Identifying and regulating intracellular pressure related to the eyes
The goggle housing system with a pump and control circuit addresses patient discomfort and improves IOP and ICP measurement accuracy, facilitating early diagnosis and treatment of eye diseases.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BALANCE OPHTHALMICS INC
- Filing Date
- 2026-04-01
- Publication Date
- 2026-06-18
AI Technical Summary
Existing non-contact tonometers for intraocular pressure measurement can cause discomfort to patients and may not accurately assess the relationship between intraocular pressure (IOP) and intracranial pressure (ICP), which is crucial for diagnosing and treating eye diseases like glaucoma.
A goggle housing system with a pump and control circuit that regulates fluid pressure within cavities around the eye, allowing for precise control of intraocular pressure based on feedback from IOP and ICP measurements, without direct contact with the eye.
Enables comfortable and accurate measurement and regulation of intraocular pressure, facilitating early diagnosis and treatment of eye conditions by balancing IOP with ICP, thereby preventing or suppressing blindness.
Smart Images

Figure 2026099857000001_ABST
Abstract
Description
Technical Field
[0001] It relates to the identification and regulation of intraocular pressure related to the eye.
Background Art
[0002] Intraocular pressure measurement is important in the diagnosis and treatment of eye diseases such as glaucoma. Early diagnosis and treatment of glaucoma are the keys to suppressing or preventing blindness. Non-contact tonometers are useful devices for intraocular pressure measurement, but they may cause discomfort to patients during use.
[0003] Patent Document 1 describes a tonometer that blows a controlled air puff onto the cornea. Patent Document 2 describes an ophthalmic composite device having an intraocular pressure measurement system that blows a fluid onto the eye from a nozzle.
[0004] Patent Document 3 describes a non-invasive method and device for measuring the intraocular pressure of the eye using vibration excitation. Patent Document 4 describes a system and method for non-invasively evaluating intracranial pressure by applying a controllable contact to at least a part of the subject's eyeball while applying a force sufficient to collapse the intraocular blood vessels and correlating the collapse pressure with the intracranial pressure.
[0005] Patent Document 5 describes an assembly and method that can be used to treat, suppress, or prevent eye symptoms. Patent Document 6 describes an assembly and method that can be used to treat, suppress, or prevent eye symptoms.
Prior Art Documents
Patent Documents
[0006]
Patent Document 1
Patent Document 2
[0007] An apparatus for at least one of the diagnosis or treatment of an ocular condition may comprise: a goggle housing sized and shaped to rest on the orbit of an eye, providing within the housing one or more cavities extending around the entire exposed anterior portion of the eye; a pump in fluid communication with one or more cavities to impart fluid pressure to one or more cavities, configured to regulate the fluid pressure within one or more cavities of the goggle housing; and a control circuit having a data interface for receiving data directly or indirectly indicating at least one of intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, and controlling the pump to regulate the fluid pressure within one or more cavities based on processing the received data as a feedback control variable, the control including using further monitoring of the received data to control the pump.
[0008] This summary provides an overview of the subject matter of this patent application. It does not provide an exclusive or exhaustive description of the invention. A more detailed description is provided to offer further information regarding this patent application.
[0009] The drawings are not necessarily drawn to scale, and similar components may be represented by the same reference numerals in various drawings. Similar reference numerals with different subscripts may represent different instances of similar components. The drawings are not limiting to the various embodiments discussed herein, but are provided as schematic examples. [Brief explanation of the drawing]
[0010] [Figure 1A] Figure 1A shows a cross-section of an example of a human eye. [Figure 1B] Figure 1B shows an example of pressure associated with a physiologically normal eye. [Figure 2] Figure 2 shows an example of an assembly for applying fluid pressure to the outer surface of the eye, for purposes such as diagnosing or treating ocular symptoms, which may include ocular abnormalities. [Figure 3] Figure 3 shows an example of a goggle housing with a port. [Figure 4] Figure 4 shows an example of a multi-component goggle housing. [Figure 5] Figure 5 shows an example of a feedback control system. [Figure 6] Figure 6 shows an example of a detector device that can be used in or in combination with this device. [Figure 7] Figure 7 shows an example of a tonometer that may be included in an example of the device or used in combination with an example of the device. [Figure 8] Figure 8 shows examples of visualization assistance devices (or VADs) that can be provided with or used in combination with this device. [Figure 9] Figure 9 shows an example of how to use this device. [Figure 10] Figure 10 shows an example of how to use this device to apply pressure to the eye for monitoring ICP. [Figure 11]FIG. 11 shows an example of a method of using the present device to apply pressure for purposes such as identifying an ICP or monitoring an ICP. [Figure 12] FIG. 12 shows an example of a method of using the present device for purposes such as identifying an index of ICP. [Figure 13] FIG. 13 shows an example of a method of using the present device so that the pressure applied to the goggle housing is synchronized with the patient's cardiac cycle. [Figure 14] FIG. 14 shows an example of a method of using the present device to identify an ICP based on an index of the patient's cardiac cycle. [Figure 15] FIG. 15 shows an example of a method of using the present device for purposes such as performing an eye diagnostic examination after the end of a treatment session. [Figure 16] FIG. 16 shows an example of a method of using the present device to identify at least one of an ICP or an IOP for diagnostic purposes or the like. [Figure 17] FIG. 17 shows an example of a method of using the present device for treatment purposes including treating at least one of acute or chronic eye abnormal symptoms. [Figure 18] FIG. 18 shows an exemplary method of setting and adjusting a treatment pressure applied to the eye for purposes such as treating an eye abnormal symptom using an IOP.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1A shows a cross-sectional view of an example of a human eye 100. The eye 100 has an anterior chamber 104 and a posterior chamber 116, which are two chambers within the sclera 122. The anterior chamber 104 is generally defined as the space between the cornea 102 and the iris 106 and is filled with aqueous humor. The pupil 107 is a hole defined by the iris 106 and allows light to enter the eye 100. The lens 110 is located behind the iris 106 and is supported by the ligament 112. The ciliary process 114, which includes the ciliary body and the ciliary muscle, surrounds the lens 110 and is located behind the iris 106.
[0012] The posterior chamber 116, located between the anterior chamber 104 and the retina 120, is filled with vitreous fluid. The retina 120 is structurally and physiologically supported by the choroid 123, located between the retina 120 and the sclera 122.
[0013] The anterior chamber 104 and the posterior chamber 116 together are called the intraocular cavity of the eye 100. Although the anterior chamber 104 is distinct from the posterior chamber 116, the separation between these two chambers is fluid, and the fluid pressure due to aqueous fluid and mucus is always equal or approximately equal. The fluid pressure within the intraocular cavity can be called intraocular pressure or IOP (IntraOcular Pressure).
[0014] To transmit visual stimuli from the retina 120 to the brain for processing, the optic nerve 118 connects the retina 120 to the brain. The optic nerve 118 is surrounded by the dural sheath 119 and immersed in cerebrospinal fluid (CSF). Since the dural sheath 119 is in fluid communication with the intracranial cavity, the CSF pressure is equal to or approximately equal to the intracranial pressure (ICP).
[0015] The optic disc 150 (optic head) connects the optic nerve 118 to the retina 120. The optic disc 150 is visible on the surface of the retina 120 and may have an orange-pink color, indicating the presence of well-perfused nerve tissue, and may exhibit an oval or nearly circular shape. The optic disc 150 may have a cup-shaped depression called the optic disc cup 154 located in the center, which may appear pale in contrast to the orange-pink color of the optic disc 150.
[0016] The ratio of the diameter of the optic disc cup 154 to the diameter of the optic disc 150 can be called the cup / disc diameter ratio. In a generally healthy eye 100, such as an eye free from glaucoma, a cup / disc diameter ratio of approximately 0.3 is generally considered normal. A cup / disc diameter ratio higher or lower than approximately 0.3 may indicate damage to the optic nerve 118, such as that associated with the progression of eye diseases including glaucoma and optic disc edema.
[0017] The intraocular cavity is separated from the intracranial cavity by the cribriform plate 124, a reticular collagen membrane structure located posterior to the sclera 122. Fibers of the optic nerve 118 can pass through the cribriform plate 124 to connect the retina 120 to the brain, while the cribriform plate 124 can maintain the pressure difference between the intraocular cavity and the intracranial cavity. The medial surface 124a of the cribriform plate receives intraocular pressure (IOP), while the medial surface 124b of the cribriform plate receives intracranial pressure (ICP).
[0018] The cribriform plate 124 is more flexible than the adjacent sclera 122 and can be deformed at any time by the influence of the translaminar pressure difference (TPD), which is the difference between IOP and ICP (e.g., TPD = IOP - ICP). The translaminar pressure gradient (TPG) can be expressed as the difference between IOP and ICP divided by the thickness of the cribriform plate 124. In a normal eye 100, IOP is generally higher than ICP, and therefore the cribriform plate is usually subjected to a backward differential pressure that causes the cribriform plate 124 to curve outward from the intraocular cavity, forming a disc cup 154 in the optic nerve head 150. In a generally healthy eye 100, the physiologically normal TPD is about 4 mmHg. Under the influence of physiologically normal TPD, the cribriform plate 124 can support the optic disc 150 in a nominal position that has a cupping / disc diameter ratio of approximately 0.3.
[0019] Changes in TPD may indicate the presence of ocular symptoms, such as ocular abnormalities in eye 100. As TPD increases from a physiologically normal TPD due to the effects of increased IOP, decreased ICP, or both, the cribriform plate 124 may bend posteriorly from its nominal position by increasing the diameter of the optic disc recess 154, thereby increasing the recess / optic disc diameter ratio to a value greater than approximately 0.3. As TPD decreases from a physiologically normal TPD due to the effects of increased ICP, decreased IOP, or both, the cribriform plate 124 may bend anteriorly from its nominal position by decreasing the diameter of the optic disc recess 154, thereby decreasing the recess / optic disc diameter ratio to a value less than approximately 0.3.
[0020] Changes in TPD may be positively correlated with 100 eye diseases. For example, glaucoma may be caused by an imbalance between IOP and ICP. An increase in IOP or a decrease in ICP can create a pressure difference on the optic nerve. ICP can affect the optic nerve; for example, in pseudotumor (idiopathic intracranial hypertension), elevated ICP may cause the optic nerve to curve forward from its physiologically normal position, and in glaucoma, high IOP and low ICP may cause the optic nerve to be pushed backward from its physiologically normal position, and decreased ICP may cause cupping of the optic nerve.
[0021] Furthermore, eye diseases such as glaucoma may also be caused by other conditions, such as metabolic disorders or impairments. In a normal eye 100, such as eye 100 which has physiologically normal function, optic nerve axonal transport can meet the metabolic demands of ganglion cells crossing the cribriform plate. In an abnormal eye 100, such as eye 100 which does not have physiologically normal function, such as eye 100 which has elevated IOP, decreased ICP, or both, inhibition or, in some cases, blockage of axonal transport across the cribriform plate may occur, which can lead to ganglion cell death and the development of glaucoma.
[0022] Changes in TPD may be positively correlated with visual field defects, such as those associated with damage to the optic nerve 118 due to reduced axonal transport. Axonal transport may represent an accumulation of cellular processes necessary to maintain the survival of nerve cells in the eye 100, such as metabolic processes. Reduced axonal transport may occur when cellular processes supporting the optic nerve 118 and retina 120 are inhibited, such as when TPD increases or decreases from physiologically normal in one or both eyes 100.
[0023] The duration of axonal transport inhibition in eye 100 can affect the degree of damage to the optic nerve 118. While acute axonal transport reduction resulting from a short-term increase or decrease in TPD from a physiologically normal level may have reversible adverse effects on the optic nerve 118, chronic axonal transport changes resulting from a prolonged increase or decrease in TPD from a physiologically normal level may lead to permanent damage to the optic nerve 118.
[0024] The eye 100 is supplied with oxygenated blood from the circulatory system by several ophthalmic artery branches, including the central retinal artery 130, the anterior ciliary artery, and the posterior ciliary artery. The central retinal artery 130 perfuses the optic nerve 118 and the retina 120. Together, the anterior and posterior ciliary arteries perfuse the ciliary process 114, the iris 116, the sclera 122, and the choroid 132. Deoxygenated blood is returned to the circulatory system via the central retinal vein 133 and vortex veins, which drain into the superior and inferior ophthalmic veins. The central retinal vein 133 passes through the subarachnoid space of the optic nerve 118 and, prior to draining into the cavernous sinus, is immersed in CSF at the patient's ICP. For this reason, the pressure within the central retinal vein 133 is equal to or higher than the ICP. There is a linear correlation between the pressure within the central retinal vein 133 and the ICP.
[0025] Eye 100 may be subjected to at least three different pressures at any given time, such as atmospheric pressure acting on the exposed anterior surface of eye 100, IOP within the intraocular lumen of eye 100, and ICP on the posterior surface of eye 100. Vessels of eye 100, such as venous vessels including the central retinal vein 133, can pass through the subarachnoid space of the optic nerve 118 and may be immersed in cerebrospinal fluid at the patient's intracranial pressure, for example, before they drain into the cavernous sinus. For this reason, pressures within venous vessels, such as the luminal pressure of the central retinal vein 133, may be equal to or higher than the ICP.
[0026] The ocular pulse wave period can be characterized by the amplitude of the ocular pulse wave, such as the difference between systolic and diastolic intraocular pressure. The ocular pulse wave period, such as the systolic and diastolic intraocular pressures of eye 100, can be associated with the patient's cardiac cycle. The intracranial pulse wave period can be characterized by the amplitude of the intracranial pulse wave, such as the difference between systolic and diastolic intracranial pressure. The intracranial pulse wave period, such as the systolic and diastolic intracranial pressures, can be associated with the patient's cardiac cycle.
[0027] Figure 1B shows an example of pressure associated with a physiologically normal eye 100. IOP may be higher than ICP, such as approximately 4 mmHg higher than ICP. IOP may include a quasi-static IOP component, such as mean IOP, whose changes over time may be gradual due to the physiological state of eye 100, and a dynamic IOP component, such as fluctuating IOP, which may change in conjunction with at least one indicator of the patient's cardiac cycle. In 162, the dynamic IOP component may be in phase with the patient's cardiac cycle indicator, etc. In 164, the dynamic IOP component may be out of phase with the patient's cardiac cycle indicator. ICP may include a quasi-static ICP component, such as mean ICP, whose changes over time may be gradual due to the patient's physiological state, and a dynamic IOP component, such as fluctuating ICP, which may change in conjunction with at least one indicator of the patient's cardiac cycle. In 163, the dynamic ICP component may be in phase with the patient's cardiac cycle indicator, etc. In 165, the dynamic ICP component may be out of phase with the patient's cardiac cycle indicator.
[0028] Transmural pressure (TMP) can be defined as the difference between the intraluminal pressure of the patient's ocular vessels, such as the central retinal vein pressure (ICP), and the atrial pressure (IOP). TMP can be associated with ocular characteristics, such as SVP, which includes SVP indices such as changes in the vascular diameter of the ocular vessels. In 166, it is possible to combine in-phase dynamic IOP and in-phase dynamic ICP components to minimize the dynamic TMP component. In 167, it is possible to combine in-phase dynamic IOP and in-phase dynamic ICP components to maximize the dynamic TMP component.
[0029] Spontaneous venous pulses (SVPs) occur in venous vessels such as the central retinal vein of eye 100. SVPs occur in highly flexible vessels, such as the veins of eye 100, near areas of significant venous pressure change, such as the pressure gradient between the IOP and ICP occurring in the retrobulbar optic nerve. The pulsation characteristics of SVPs can depend on several variables, including IOP and ICP.
[0030] ICP can be assessed non-invasively by temporarily increasing the IOP in the patient's eye 100. In one example, an instrument can be placed in contact with the eye 100, such as the anterior part of the eye 100, and pressed against the eye 100 to increase the IOP of the eye 100. While the IOP of the eye 100 is being increased, a person other than the patient, such as a healthcare professional, can observe one or more vessels in the eye 100, such as veins, until at least one criterion, such as an ocular characteristic change criterion, is met. In one example, an ocular characteristic change criterion may include collapse of the central retinal vein 133, which is caused by the increase in IOP in the eye 100.
[0031] The IOP of eye 100 can be reduced by removing the instrument pressed against eye 100, allowing the collapsed blood vessels to restore their approximately circular cross-sectional shape. While reducing the IOP of eye 100, a person other than the patient, such as a medical professional, can observe one or more blood vessels, such as veins, in eye 100 until a criterion, such as an ocular characteristic recovery criterion, is achieved. Detection of the ocular characteristic recovery criterion may indicate that the affected biological tissue has recovered to an ambient state, such as the normal physiological state that existed before the instrument was pressed against eye 100. In one example, the ocular characteristic recovery criterion may include the recovery to an ambient cross-sectional shape, such as the approximately circular shape of the central retinal vein 133.
[0032] Ocular properties may represent physical properties of the patient's body, such as at least one of the physical properties of the patient's eye 100, or physical properties of the patient's body related to the patient's eye 100. Indicators of ocular properties may include numerical values related to a particular level or quantity of the ocular property. These numerical values may represent a single indicator of the ocular property, such as a first or second value, or a change in an indicator of the ocular property, such as the difference between the first and second values.
[0033] Indicators of ocular characteristics related to eye 100 may change due to the influence of forces acting on the patient's body, such as when the patient's body is subjected to inertial forces. Inertial forces can be generated in eye 100 due to rapid acceleration or deceleration of eye 100.
[0034] ocular characteristic indicators associated with eye 100 may change due to changes in hydrostatic pressure, such as hydrostatic pressure differences within the patient's body. Ocular characteristic indicators associated with eye 100 may change due to changes in IOP hydrostatic pressure and ICP hydrostatic pressure, such as when the patient moves from a first position, such as standing, to a second position, such as sitting or prone. Changes in ocular characteristic indicators affected by hydrostatic pressure differences may include changes in the inner diameter or diameter of blood vessels, such as at least one of the retinal veins or retinal arteries. Changes in the inner diameter or diameter of blood vessels may include pulsations, such as pulsations detected by imaging devices due to changes in systemic blood pressure, such as systole and diastolic phases, which may indicate a cardiac cycle.
[0035] Indicators of eye characteristics related to the eye 100 may change due to the influence of forces applied to the eye 100, such as when the eye 100 receives gauge pressure applied to the cavity 212 of the goggle housing 210 by the device 200. A force can be generated in front of the eye 100 by applying fluid pressure, such as positive or negative gauge pressure, to the cavity 212 by the pump 220.
[0036] An index of ocular characteristics associated with eye 100 can be calculated or otherwise assessed as a function of one or more parameters, including one or more indices of ocular characteristics and one or more indices of physical parameters, such as the patient's body mass index (BMI) or the patient's chronological age. An index of ICP may include an estimate of CSF pressure, such as an estimate of CSF pressure calculated based on the patient's blood pressure, BMI, and chronological age information.
[0037] Ocular properties may include intracellular pressure of the eye 100. Intracellular pressure may include pressures associated with the eye 100, such as IOP, ICP, episcleral venous pressure (EVP), or at least one of the following: intermembrane pressure difference (TPD), intermembrane pressure gradient (TPG), or orbital pressure, which are the pressures between the patient's eye 100 and the body. Intracranial pressure (ICP) may, in some cases, be called cerebrospinal fluid pressure (CSFP).
[0038] The eye properties may include physical properties of the eye 100, such as physical properties describing the structure of the eye 100, or physical properties related to the structure of the eye 100. The structure of the eye 100 may include components of the eye, such as the cribriform plate 124, the retina 120 including the retinal nerve fiber layer (RNFL), and the choroid 123. The physical properties of the structure of the eye 100 may include at least one of the following: the thickness of the structure, the color of the structure, the reflectance of the structure which can be related to the color and reflectivity of the structure, or the movement of the structure in the eye 100 relative to an external structure of the eye 100, such as at least one of a visualization support device or goggle housing 210, or relative to the structure of the eye 100, or at least one of them. In one example, the eye properties may include the movement of the cribriform plate, such as the movement relative to an external structure of the eye 100, or the movement of the cribriform plate relative to the anterior surface of the eye 100. The structure of the eye 100 may include blood vessels of the eye 100, such as arterial vessels or venous vessels that may include the central retinal vein 133. The physical properties of the blood vessels of the eye 100 may include the cross-sectional diameter (or diameter) of the vessel, such as the inner diameter of the central retinal vein 133, or the shape of the vessel, such as the cross-sectional shape of the central retinal vein 133. In one example, the pressure within the central retinal vein 133 can approximate the ICP. The physical properties of the blood vessels of the eye 100 may include at least one of the color properties or reflectance (or reflected light intensity) properties of the vessel.
[0039] Ocular characteristics may include the patient's physical parameters associated with eye 100. Physical parameters may include other metrics such as chronological age and body mass index (BMI). Physical parameters may include indicators of fluid pressure applied to eye 100, such as fluid pressure applied to the anterior part of eye 100. Physical parameters may include indicators of the cardiac cycle, such as heart rate, indicators of systemic blood pressure, such as systolic and diastolic blood pressure, or indicators of venous spontaneous pulsation. Indicators of the cardiac cycle may include at least one SVP characteristic, such as SVP frequency, changes in vascular diameter due to SVP, phase of SVP relative to systemic blood pressure, such as systemic systolic and systemic diastolic phases, blood flow velocity at SVP, or blood column oscillation associated with SVP.
[0040] Ocular properties may include the flow properties of the vascular tissue of ocular 100, such as the flow properties of the vascular tissue of ocular 100. The flow properties of the vascular tissue of ocular 100 may include at least one of the following: mean or other central tendency of blood flow velocity, which may be related to IOP and CSF levels, systolic and diastolic blood flow velocity, and blood flow density. The flow properties of the vascular tissue may change periodically, for example, the flow properties may be related to the cardiac cycle. The flow properties of the vascular tissue may be related to IOP, CSF, or both IOP and CSF, for example, the flow velocity within the vessel may be affected by changes in CSF. The flow properties may include composite properties, such as ocular properties calculated from one or more ocular properties. Composite properties may include the Pulsatility Index (PI) and the Resistivity Index (RI). ICP can be assessed using methods that may include measuring venous outflow pressure, measuring central retinal artery blood flow, and assessing ICP using at least one of the venous outflow data and its relationship to pulsation or its relationship to resistivity.
[0041] The device 200 can be used in one or more detectors 513, or in combination with one or more detectors 513, to apply fluid pressure, such as therapeutic pressure, to the eye 100. By applying therapeutic pressure to the eye 100 to treat one or more ocular symptoms of the eye 100, pressure indicators related to the eye 100, such as indicators of physiological parameters, can be adjusted.
[0042] Figure 2 shows an example of a device 200 for applying fluid pressure to the outer surface of an eye 100, for purposes such as diagnosing or treating ocular symptoms that may include ocular abnormalities. By applying fluid pressure to the eye 100, changes can be induced in the eye 100 to alter the properties of the eye 100, such as the fluid pressure associated with the eye 100.
[0043] The device 200 may include a goggle housing 210, a pump 220 in fluid communication with the goggle housing 210, a control circuit 230 that communicates electrically with the pump 220, and a positioning device 240 connected to the goggle housing 210. In one example, the device 200 may include one or more housings 210 to form a set of goggles that can be placed over a patient's eye 100 for the diagnosis or treatment of an ocular condition. In one example, the image processor circuit may include at least one of the control circuit 230 or the VAD image processor circuit.
[0044] The device 200 can provide adjustable control of IOP in the patient's eye 100, such as balancing IOP with ICP or controlling TPD in the patient's eye 100 in other ways, for the treatment of ocular abnormalities. For example, ocular abnormalities such as glaucoma can be treated by using goggles and a pump to create a light vacuum on the outer surface of the patient's eye 100 inside the goggle housing 210, such as a vacuum of 10-15 mmHg relative to the ambient atmospheric pressure outside the goggles, to lower IOP and balance TPD. For example, ocular abnormalities such as vision impairment and intracranial pressure syndrome (or VIIP), which may be caused by microgravity-induced ICP elevation, can be treated by applying positive pressure on the surface of the patient's eye 100 inside the goggle housing 210 to raise ICP and balance TPD. VIIP may be accompanied by one or more of the following diverse ocular abnormalities: hyperopia, scotoma, cottony white spots, choroidal folds, optic nerve sheath dilation, flattening of the eyeball, and optic nerve edema.
[0045] The goggle housing 210 can be sized and shaped to surround the patient's eye 100, such as by being placed on the orbit of the eye 100, without contacting the eye 100, but at a distance from it. When the goggle housing 210 is placed in contact with the patient, it may have or define a cavity 212 between the goggle housing 210 and the patient. The goggle housing 210 may extend around the eye 100, such as the entire exposed front portion of the eye 100. The goggle housing 210 may have a sealing material 214 that can be positioned along the periphery of the goggle housing 210. The goggle housing 210 can be positioned above the eye 100 so that it can be placed in contact with the patient so that the sealing material 214 forms a gasket between the goggle housing 210 and the patient. In one example, the goggle housing 210 may be positioned in contact with the patient's skin to form a gasket between the goggle housing 210 and the patient, for example, to maintain a desired fluid pressure level within the housing using a pump. In one example, the gasket may form a hermetic seal between the cavity 212 and the surrounding environment, which may include an airtight seal.
[0046] The goggle housing 210 may be constructed of a material that has sufficient rigidity to support or maintain the fluid pressure difference between the cavity 212 and the surrounding atmosphere or other areas such as the cavity 212. The fluid pressure difference may include the difference between the fluid pressure within the cavity 212 and the fluid pressure of the surrounding environment outside the goggle housing 210. The fluid pressure within the cavity 212 may act on the front of the eye 100 to impose a positive or negative force on the front of the eye 100 without causing the eye 100 to come into physical contact with a non-gaseous fluid mass or element, such as affecting the IOP within the patient's eye 100 to decouple the IOP from the ICP. The goggle housing 210 may be constructed of a light-transmitting material so that the patient can see outside through the goggle housing 210. Furthermore, the light-transmitting material may enable medical professionals to observe the eye 100, including the characteristics of the intraocular cavity, through the goggle housing 210 using measuring instruments.
[0047] Figure 3 shows an example of a goggle housing 210 having a port 320. The port 320 can function as a passage between the inner surface 216 and the outer surface 218 of the goggle housing 210 to allow fluid communication between the cavity 212 and the atmosphere surrounding the goggle housing 210. The port 320 may allow one or more objects, such as one or more measuring instruments, to be inserted through the port 320 so as to be positioned close to the eye 100. The port 320 can be located on any surface of the goggle housing 210. A first sealing joint (e.g., a valve or seal) can be located between the measuring instrument and the port 320 to form a hermetic seal or other seal between the measuring instrument and the port 320. The first sealing joint may include one or more sealing structures, such as one or more membranes, sleeves, O-rings, or bellows, and may be made of one or more sealing materials such as plastic, rubber, copolymer, or elastomer material.
[0048] The goggle housing 210 may have a stopper 322 that can be inserted into the port 320 to suppress or prevent the flow of gas, liquid, or other fluid between the cavity 212 and the atmosphere surrounding the goggle housing 210. A second seal joint may be positioned between the stopper 322 and the port 320 to form a hermetic seal between the stopper 322 and the port 320. The stopper 322 may have any volumetric shape that can be used in combination with the port 320, and the second seal joint forms a hermetic seal. The stopper 322 may have a shape having at least one tapered surface that can be inserted into the port 320, such as a frustoconical or conical cross section, the tapered surface forming a second seal joint that fits into the port 320 to form a hermetic seal. The stopper 322 may have a shape that can be formed on the port 320 by the patient. In one example, a certain amount of flexible and moldable material can be manually molded to fit into the port 320, forming a stopper 322 and a second sealing joint that fits into the port 320. The stopper 322 may be made of a light-transmitting material so that the patient can see outside through the stopper 322. The stopper 322 may include a surface coating device to cover the port 320, such as a thin film configured to be gas-impermeable. The surface coating device may have at least one adhesive surface, such as an adhesive surface configured to adhere to the surface of the goggle housing 210, such as at least one of the inner surface 216 or outer surface 218 of the goggle housing 210.
[0049] Figure 4 shows an example of a multi-component goggle housing 210. The goggle housing 210 may have a base 424 and a cap 426 that can be coupled to the base 424 at a joint 428. The base 424 can be sized and shaped to surround the eye 100, spaced away from the eye 100 without contacting the eye 100. When the base 424 is placed in contact with a patient, such as in contact with the orbit of the eye 100, it may include or define part of one or more sealed cavities 212. The base 424 may have a sealing material 214 that can be positioned along the periphery of the base 424. The base 424 can be positioned above the eye 100 so that it can be placed in contact with the user's skin so that the sealing material 214 forms a gasket between the base 424 and the skin. The base 424 can be fixed to the patient so as to maintain its position over the patient's eyes, by using at least one of the following: a positioning strap connected to the base 424 and configured to generally surround the patient's head, or an adhesive such as an adhesive applied to the interface between the base 424 and the patient.
[0050] The cap 426 can be attached to the base 424 at joints 428, etc., to form the goggle housing 210 so as to define a cavity 212 within the goggle housing 210. The cap 426 may have a port 320 for positioning one or more objects, which may include one or more measuring instruments (or parts thereof), in close proximity to the eye 100. The measuring instrument can be mounted on the cap 426 such that its distal end is in close proximity to the eye 100. In one example, mounting the measuring instrument to the cap 426 is possible by removing the stopper 322 from the port 320 and inserting at least a part of the measuring instrument into the port 320 to mount the measuring instrument to the cap 426. The measuring instrument can be mounted on the cap 426 so as to form a hermetic seal between the measuring instrument and the cap 426, by using one or more fastening connections, such as screw connections, friction connections, or fastening connections that may involve one or more fastening devices extending between the base 424 and the cap 426. One or more measuring instruments can be integrated with the cap 426 or attached to the cap 426; for example, the measuring instruments can be permanently fixed to the cap 426.
[0051] The joint 428 may include a seam between the base 424 and the cap 426. In one example, the cap 426 may be coupled to the base 424 at the joint 428 to form the goggle housing 210. The joint 428 may form a hermetic seal between the base 424 and the cap 426, for example, to support or maintain a fluid pressure difference between the cavity 212 and the atmosphere or other areas such as other cavities 212 surrounding the goggle housing 210. The joint 428 may include a joint seal, which may include a convex portion integral to the base 424, a grooved portion integral to the cap 426, and a continuous sealing component such as an O-ring gasket seated in the grooved portion of the cap 426, the continuous sealing component being configured to deform and seal when the convex portion of the base 424 strikes it, for example, to form the goggle housing 210. The joint 428 may include a joint seal comprising a convex portion integrated with the cap 426, a grooved portion integrated with the base 424, and a continuous sealing component such as an O-ring gasket seated in the grooved portion of the base 424. The continuous sealing component is configured to deform and seal when the convex portion of the cap 426 comes into contact with the base 426, such as when forming the goggle housing 210.
[0052] The goggle housing 210 can influence the visualization of the eye 100 by the measuring instrument by changing the focus between the eye 100 and the measuring instrument. Focus can be assisted or corrected between the eye 100 and the measuring instrument by using a corrective lens which may include at least one of a converging lens, a diverging lens, or a combination of both. The corrective lens can be placed between the eye 100 and the measuring instrument, such as between the eye 100 and the goggle housing 210, or between the goggle housing 210 and the measuring instrument. The corrective lens can be attached to the goggle housing 210, such as on the inner surface 216, the outer surface 218, or both. The corrective lens can be incorporated into the goggle housing 210 so as to form part of the structure of the goggle housing 210. The corrective lens can be incorporated into the cap 426 to give medical professionals or other users the opportunity to select an appropriate correction rate for use with a given measuring instrument.
[0053] Referring again to Figure 2, the pump 220 can be fluidly connected to the cavity 212 of the goggle housing 210, for example, via the tube 222. The pump 220 can influence one or more physical properties of the environment in the cavity 212, such as humidity, temperature, or fluid pressure.
[0054] Pump 220 can apply and adjust fluid pressure, such as positive or negative gauge pressure, within the cavity 212 of the goggle housing 210 to generate a force in the eye. Gauge pressure may include local pressure within the cavity 212 relative to the adjacent ambient atmospheric pressure outside the cavity, such as atmospheric fluid pressure. Positive gauge pressure may include fluid pressure within the cavity 212 that is higher than atmospheric pressure. Positive gauge pressure within the cavity 212 can act as a force that increases the pressure in front of the eye 100 relative to the IOP of the eye 100, such as to increase the IOP of the eye 100. Negative gauge pressure may include fluid pressure within the cavity 212 that is lower than atmospheric pressure. Negative gauge pressure within the cavity 212 can act as a force that decreases the pressure in front of the eye 100 relative to the IOP of the eye 100, such as to decrease the IOP of the eye 100.
[0055] The pump 220 may include one or more devices that can be selected to apply gauge pressure to the cavity 212 of the goggle housing 210. To enable the pump 220 to generate positive or negative gauge pressure within the goggle housing 210, the pump 220 may include one or more of a compression pump, a vacuum pump, or a reversible pump. For applying gauge pressure to the cavity 212 without requiring continuous operation of the pump 220, the pump 220 may have a reservoir, such as one for containing the positive or negative gauge pressure. In one example, the pump 220 may be operated for a period of time to generate an operating gauge pressure in the reservoir, and then switched off for a period of time, such as until the gauge pressure in the reservoir crosses a threshold gauge pressure, in order to maintain the operating gauge pressure in the reservoir. The pump 220 may have a reservoir for containing positive gauge pressure and a venturi valve communicating with the reservoir and the cavity 212, thereby generating negative gauge pressure in the cavity 212 by releasing a gaseous fluid from the positive gauge pressure reservoir through the venturi valve to create a vacuum with negative gauge pressure in the cavity 212.
[0056] Pump 220 may have a controllable vent that is in fluid communication with the cavity 212, for example, to adjust the gauge pressure inside the goggle housing 210. The controllable vent may include a valve, for example, to adjust the flow of gaseous fluid between the cavity 212 and the surrounding environment, and an actuator connected to the valve and control circuit 230, for example, to open and close the valve in response to command signals sent from the control circuit 230, as required to maintain a desired gauge pressure inside the cavity 212.
[0057] The pump 220 can apply pressure, such as positive or negative gauge pressure, supplied to the goggle housing 210 to generate force in the eye. The appropriate duration of the gauge pressure applied to the eye may vary depending on the eye condition being treated.
[0058] Diagnostic regimens, such as those for diagnosing ocular symptoms, may require the application of gauge pressure supplied to the cavity 212 by pump 220 over a relatively short period of time, such as seconds or minutes. For example, a procedure for diagnosing ocular symptoms, such as acute or chronic ocular symptoms like glaucoma and optic disc edema, may require application over a period of 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 16 seconds, 17 seconds, 18 seconds, 19 seconds, 20 seconds, 21 seconds, 22 seconds, 23 seconds, 24 seconds, 25 seconds, 26 seconds, 27 seconds, 28 seconds, 29 seconds, 30 seconds, 31 seconds, 32 seconds, 33 seconds, 34 seconds, This may involve applying gauge pressure using the device 200 for at least one of the following durations: 35 seconds, 36 seconds, 37 seconds, 38 seconds, 39 seconds, 40 seconds, 41 seconds, 42 seconds, 43 seconds, 44 seconds, 45 seconds, 46 seconds, 47 seconds, 48 seconds, 49 seconds, 50 seconds, 51 seconds, 52 seconds, 53 seconds, 54 seconds, 55 seconds, 56 seconds, 57 seconds, 58 seconds, 59 seconds, 60 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, or more than 10 minutes.
[0059] Treatment regimens for acute ocular conditions may require the application of gauge pressure supplied to the cavity 212 by the pump 220 over relatively short periods of time, such as minutes, hours, days, or weeks. For example, a treatment regimen for acute ocular conditions such as glaucoma and optic disc edema may involve the application of gauge pressure using the device 200 over at least one of the following periods: 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 24 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 1 week, 2 weeks, 3 weeks, or 4 weeks.
[0060] Treatment regimens for acute ocular symptoms may require the application of gauge pressure at intermittent time intervals, such as cyclical or acyclical intervals. Cyclical regimens may involve applying therapeutic pressure periodically, such as mainly at night, until acute ocular symptoms resolve, following a circadian cycle. Acyclic regimens may involve applying therapeutic pressure acyclically, such as applying it when indicators of physiological parameters, including IOP, are outside a specified range, and discontinuing it when the indicators of physiological parameters are at or within the desired level.
[0061] Treatment regimens for chronic ocular conditions such as glaucoma or optic disc edema may require the application of gauge pressure supplied to the cavity 212 by the pump 220 over relatively long periods of time, such as days, weeks, months, or years. For example, a treatment regimen for chronic ocular conditions such as glaucoma and optic disc edema may involve the application of gauge pressure using the device 200 over at least one of the following periods of time: 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, or 10 years. For example, a treatment regimen for chronic ocular conditions such as glaucoma and optic disc edema may involve the lifetime application of gauge pressure to the eye using device 200.
[0062] Treatment regimens for chronic ocular symptoms may require the application of gauge pressure at intermittent time intervals, such as cyclical or acyclic intervals. Cyclical regimens may involve applying therapeutic pressure periodically, such as during the circadian cycle, throughout the patient's lifetime, primarily at night, to restore axonal transport. Acyclic regimens may involve applying therapeutic pressure acyclically, such as when indicators of physiological parameters, including IOP, are outside a specified range, and discontinuing therapeutic pressure when the indicators of physiological parameters are at or within the desired level.
[0063] Pump 220 can modulate the gauge pressure applied to one or more housings, such as periodically and aperiodically. Periodic gauge pressure may include gauge pressure that changes in magnitude at regular intervals, such as by a sinusoidal signal, a periodic nonsinusoidal signal, and a repetitive process. In one example, the gauge pressure applied to the goggle housing 210 may change in a roughly sinusoidal manner with a period of approximately 24 hours to compensate for the natural circadian rhythm of IOP in the patient's eye 100. Periodic gauge pressure may include gauge pressure that changes in frequency, such as the time between repetition intervals of a periodic signal. In one example, the gauge pressure applied to the housing may change in frequency, such as when the gauge pressure applied to the cavity 212 may change as a function of cardiac activity, such as heart rate and blood pressure measured by a detection device such as a blood pressure monitor.
[0064] Non-periodic gauge pressure may include gauge pressure whose magnitude changes at irregular intervals, such as due to non-periodic signals and non-repeating processes. The gauge pressure applied to the housing may change non-periodicly depending on indicators of physical parameters, such as the patient's position relative to a coordinate system and the patient's position measured by an inclinometer. For example, the indicator of position may include changes in position, such as the patient moving from a first position, such as standing, to a second position, such as sitting or lying prone. The gauge pressure applied to the goggle housing 210 may change non-periodicly depending on the sum of one or more periodic and non-periodic signals. For example, the gauge pressure applied to the goggle housing 210 may include a periodic component, such as gauge pressure based on cardiac activity, and a non-periodic component, such as gauge pressure based on the patient's position.
[0065] The control circuit 230 can coordinate the operation of the device 200, such as applying fluid pressure to the cavity 212. The control circuit 230 may include a central processing unit (CPU), such as a microcontroller or microprocessor, that executes one or more programs or algorithms; a data interface 232, which includes memory such as cache memory, one or more input channels for receiving one or more data input signals from one or more components of the device 200, and data output channels for transmitting indicators of processed data signals to other components of the device 200; and a user interface (UI), such as a UI, designed to receive indicators of data input signals, such as information derived from user interaction with the device 200, and to display indicators of data output signals, such as information regarding the operating parameters or operating status of the device 200. The CPU can process one or more data input signals, such as to form a data output signal that includes a processed composite signal. The control circuit 230 can be used in a control system, such as a feedback control system, to operate or improve the performance of the device 200, for at least one of diagnostic or therapeutic applications.
[0066] The positioning device 240 can fix the goggle housing 210 to the patient so as to maintain the position of the goggle housing 210 over the patient's eye 100. The positioning device 240 can be made adjustable to fit the patient's specific anatomical structure. The positioning device 240 may include an adjustable strap. The positioning device 240 may be integrated with the goggle housing 210, for example, the positioning device may be permanently attached to the goggle housing 210. The positioning device 240 may include an adhesive, such as an adhesive applied to the goggle housing 210 and positioned between the goggle housing 210 and the patient's skin, in order to adhere the goggle housing 210 to the patient's skin. The adhesive may include any material suitable for maintaining a seal, such as a hermetic seal, between the cavity 212 and the surrounding environment, such as an adhesive approved for use on skin, such as a medical-grade adhesive.
[0067] Figure 5 shows an example of a feedback control system 500. The feedback control system 500 can be used for control such as correcting the behavior of the device 200. The feedback control system 500 may include a goggle housing 210, a pump 220, a control circuit 230, a housing sensor 506, and a detector device 508.
[0068] The goggle housing 210 can cover the eye 100. The eye characteristics of the eye 100 can be described by eye parameters 502. The eye parameters 502 can be detected by a detector device 508 that converts the eye parameters 502 into electrical signals such as a detected eye parameter signal 510 that can represent an index of the eye parameters 502. The housing pressure parameter 505 can be detected by a housing pressure sensor 506 that converts the housing pressure parameter 505 into electrical signals such as a detected housing pressure parameter 507 that can represent an index of the housing pressure parameter 505. Signals such as at least one of the detected eye parameter signal 510, the target eye parameter signal 512, or the detected housing sensor signal 507 can be received by the data interface 232. The target eye parameter signal 512 may include an electrical signal that represents an index of a target eye parameter, such as a target value of the eye characteristics. The data interface 232 is capable of communication, such as electrical communication, with the control circuit 230. The control circuit 230 can receive signals from the data interface 232, process the signals from the data interface 232, and transmit indicators of the pump control signal 501 to the pump 220, such as to form the pump control signal 501. The pump 220 can operate in accordance with the pump control signal 501 to generate a fluid pressure level 503 to supply to the goggle housing 210.
[0069] Figure 6 shows an example of a detector device 508 that can be used in or in combination with the device 200. The detector device 508 may include a pressure sensor or other device capable of detecting direct measurements of internal pressure, such as at least one of intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, by detecting a parameter related to at least one of the following: intraorbital pressure, ICP, or IOP. In one example, the relationship between ICP and IOP may include at least one indicator, such as SVP, cupping / papillary diameter ratio, changes in the radius of curvature of the eye 100, such as posterior flattening of the eyeball, or changes in the axial length of the eye 100, such as changes in the distance between the anterior surface and the posterior surface of the eye 100. The sensor system 508A can be implanted or placed in the aqueous humor of the eye 100, such as mucus or aqueous fluid, or anchored to the inner surface of the eye 100. The sensor system 508A can be configured to be used with or in combination with an intraocular lens, such as an independent sensor located close to the intraocular lens, or a sensor that is incorporated into a replacement intraocular lens during cataract surgery or the like and implanted in the eye 100.
[0070] Sensor 508A may include a passive or unpowered sensor, such as a manometer sensor system. The manometer sensor system may have a manometer pressure sensor and a manometer data receiver. The manometer pressure sensor may include a sensing element, such as a sensing element that can be implanted in the intraocular cavity by being incorporated into an implantable replacement ophthalmophotolens, so that the manometer pressure sensor may be visible through the cornea. The manometer pressure sensor may include a meniscus, such as the interface between at least two working fluids of the manometer. In one example, where the first fluid pressure and the second fluid pressure are different, the meniscus may be located at a first level when subjected to a first fluid pressure including a first IOP, and at a second level when subjected to a second fluid pressure including a second IOP.
[0071] The manometer data receiver may include an imaging device such as VAD509. VAD509 may include a camera system 509E, such as at least one of a fundus camera, a video camera, or a smartphone camera. The camera system 509E may be mounted on a frame such as a goggle housing 210. The camera system 509E may be positioned close to the patient's eye 100, such as by ensuring a clear line of sight between the camera system 509E and the manometer pressure sensor so that it is visible through the cornea. For example, the imaging device may include or be similar to one or more commercially available devices, such as a device sold by Apple Inc. (Cupertino, California) under the trademark GOOGLE GLASS®. In one example, the camera system 509E may be positioned in the cavity 212 of the goggle housing 210, such as by directing the camera towards the eye 100 and configuring it to focus on and visualize a pressure indicator of a sensor, such as the meniscus of the manometer pressure sensor.
[0072] Sensor 508A may include an active sensor or a powered sensor, such as a wireless transmitting sensor system. The system may have a pressure transducer and a pressure transducer local interface. The pressure transducer may include at least one of a battery-powered sensor or a transcutaneous-powered transducer, such that it can be implanted in the intraocular cavity to detect an indicator of ocular characteristics such as IOP. The pressure transducer local interface is capable of electrical communication with the pressure transducer, such as for wireless transmission of energy to the pressure transducer, such as powering a pressure disk sensor, and for wireless reception of data from the pressure transducer, such as an indicator of IOP. For example, sensor 508A may include or be similar to one or more intraocular pressure measurement systems and devices sold by Implandata Ophthalmic Products GmbH (Hannover, Germany) under the trademark EYEMATE®. In one example, the pressure transducer local interface may be incorporated into the device 200, such as by being located within the goggle housing 210. In the goggle housing 210, the pressure transducer local interface can be positioned close to the pressure transducer to enable wireless communication between the pressure transducer and the pressure transducer local interface.
[0073] The detector device 508 may include a direct ICP sensor 508B that detects ICP indicators by direct exposure to ICP, etc. The sensor 508B may be placed in or communicate with a part of the body receiving ICP, such as the ventricles or spinal cord. The sensor 508B may include a powered ICP sensor, such as at least one of a battery-powered sensor or a transcutaneous sensor, which can be at least partially implanted in the body to detect ICP indicators, and an indicator acquisition device, such as a device for wirelessly collecting data on ICP indicators from the powered sensor. For example, the sensor 508B may include or be similar to one or more devices and methods described in the paper "Laboratory testing of the Pressio intracranial pressure monitor" by Allin et al., published in Neurosurgery, Vol. 62, #5 (May 2008), p. 1158. For example, the sensor 508B can be implanted in the patient's ventricle or elsewhere via a surgical approach, and can also be electrically connected to a control circuit via the data interface 232.
[0074] The detector device 508 may include a device for detecting indirect measurements of internal pressure, such as intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, by detecting a parameter associated with at least one of the following: intraorbital pressure, ICP, or IOP.
[0075] The detector device 508 may include an indirect IOP sensor, such as a tonometer 508C, or other device capable of detecting an IOP index by detecting an IOP-related index. Applanation tonometry can estimate IOP based on applying the force required to flatten (or applanate) a portion of the cornea. Applanation tonometers may include non-contact tonometers, such as air puff tonometers or ocular response analyzers. Applanation tonometers may include contact tonometers, such as Goldmann tonometers, Perkins tonometers, dynamic contour tonometers, electronic press-in tonometers, rebound tonometers, air tonometers, press-in tonometers, non-corneal tonometers, or transeyelid tonometers.
[0076] Figure 7 shows an example of a tonometer 508C provided with or used in combination with an example of the device 200. The goggle housing 210 of the device 200 may have a port 320 through which a portion of the tonometer 508C can be extended to position such portion of the tonometer 508C in very close proximity to the eye 100. The port 320 may have a valve or sealing joint to form a sufficient hermetic seal between the port 320 and the tonometer 508C so that the gauge pressure in the cavity 212 of the goggle housing 210 can be maintained during the operation of the tonometer 508C for measuring the IOP of the eye 100. The tonometer 508C may include a contact tonometer, such as a rebound tonometer, including a rebound tonometer device sold by Icare Finland Oy (Espoo, Finland) under the trademark ICARE®.
[0077] The tonometer 508C may include a non-contact tonometer such as an air-puff tonometer. The air-puff tonometer may include an actuation element that can apply a pressurized air jet to the surface of the eye 100. When used in or in combination with the device 200, such as the device 200 having a cavity 212 of a first fluid pressure, the air-puff tonometer may be configured to generate a pressurized air jet, such as a pressurized air jet of a second fluid pressure that can be selected relative to (e.g., higher than) a first fluid pressure applied to the cavity 212, for example, to flatten the eye 100 in the presence of a first fluid pressure applied to the cavity 212. For example, the tonometer 508C may include or be similar to the air-puff tonometer device sold by Topcon Medical Systems Incorporated (Oakland, New Jersey, USA) under the trademark CT-80 NON-CONTACT COMPUTERIZED TONOMETER®. In one example, the goggle housing 210 can be integrated into the CT-80 such that the measuring nozzle and measuring window are located inside the goggle housing 210.
[0078] The detector device 508 may include an ocular surface sensor system 508D, such as a device capable of making sufficient contact with the eye 100, such as the surface of the sclera or cornea of the eye 100. The ocular surface sensor 508D can measure deformation of the surface of the eye 100. Such deformation can be correlated with an index of internal pressure, such as IOP. The ocular surface sensor system 508D may be incorporated into a contact lens, such as a corrective or cosmetic contact lens, or can be used in combination with a contact lens. The ocular surface sensor 508D may include a wirelessly powered microsensor device mounted on a contact lens-type device, such as for detecting one or more circumferential changes in the surface of the eye 100, such as those resulting from changes in one or more internal pressures of the eye 100, which may include IOP. The ocular surface sensor 508D may include an indicator acquisition interface circuit, which may include an indicator acquisition device such as an antenna or other transmitter, and a receiver for wirelessly collecting information on one or more indices of one or more ocular characteristics of the eye 100 detected by the ocular surface sensor. For example, the eye surface sensor system 508D may include, or be similar to, a contact lens type detection system device sold by Sensimed AG (Lausanne, Switzerland) under the trademark SENSIMED TRIGGERFISH®. In one example, the indicator acquisition interface circuit can be incorporated into the device 200, such as by being located inside the goggle housing 210. In the goggle housing 210, the indicator acquisition interface circuit can be positioned close to the pressure transducer to enable wireless communication between the indicator acquisition device and the indicator acquisition interface circuit.
[0079] The detector device 508 may include, or be used in combination with, an optical indicator sensor system 508E, which may include an implantable device that can be placed inside the eye 100, such as in an aqueous liquid or a mucus, and a detector unit. The implantable device may include a sensor that may include a pressure-sensitive nanophotonic structure. The detector unit may be incorporated into the goggle housing 210 so as to be in close proximity to the implantable device, such as in a direct line of sight to the implantable device. The detector unit may have an energy source that can excite the implantable device with electromagnetic energy from at least one of the ultraviolet frequency, visible frequency, or near-infrared frequency ranges, and may receive reflected electromagnetic energy from the implantable device. The received reflected electromagnetic energy may include indicators of eye parameters such as IOP. The received reflected electromagnetic energy may be processed by a sensor interface control circuit, for example, to detect one or more changes in optical indicators of light, such as those resulting from a change in the IOP of the eye 100.
[0080] The detector device 508 may include a blood pressure sensor system 508F that includes a device capable of detecting one or more indicators of blood pressure, such as by at least one of auscultation, oscillometric detection, or photoplethysmography (or PPG) detection. The blood pressure indicator may include one or more indicators of one or more cardiac cycle blood pressure parameters, such as systolic blood pressure, diastolic blood pressure, orbital pressure, or episcleral venous pressure, and one or more related parameters such as heart rate. Orbital pressure may include pressure such as contact pressure between the eye 100 and the orbit, such as the bones forming the orbit, such as the frontal bone, lacrimal bone, ethmoid bone, zygomatic bone, maxilla, palatine bone, and sphenoid bone.
[0081] A stethoscope may be introduced and used to detect one or more sounds from within the body that may be generated by a cardiac cycle, including at least one of the heartbeat or blood flow in a blood vessel. A stethoscope may include at least one of the following: a stethoscope such as an acoustic stethoscope or an electronic stethoscope, or a stethoscope used in or in combination with a blood pressure monitor such as a mercury sphygmomanometer or an aneroid sphygmomanometer.
[0082] Oscillometric devices can be introduced and used to detect intravascular vibrations, such as vibrations caused by blood flow within blood vessels. An oscillometric device may include one or more sensors, such as at least one of an electrostatic sensor or a capacitive sensor, and may be positioned in contact with or in close proximity to a patient, for example, to detect vibrations caused by blood flow within the patient's blood vessels.
[0083] A PPG device can be introduced and used to detect light reflections, such as from a patient's skin. A PPG device may include a light source, such as a light source that can be shone onto the patient's skin, and a light receiver, such as a receiver for receiving reflected light from the patient's skin. The light source can emit light at a selected wavelength or a variety of different wavelengths, such as green light having a wavelength of about 525 nanometers or infrared light having a wavelength of about 800 nanometers. For example, a PPG device may include, or be similar to, a device sold by Apple Inc. (Cupertino, California) under the trademark APPLE WATCH®. In one example, the APPLE WATCH can communicate with the device 200 via a wireless interface that communicates with a control circuit 230.
[0084] The detector device 508 may include an inclinometer sensor 508G. The inclinometer sensor 508G can provide an index of ocular parameters, such as one or more hydrostatic pressure indices related to the eye 100, such as hydrostatic pressure difference. The inclinometer sensor 508G may include a combination of sensors, such as a tilt sensor, an accelerometer, a multi-axis inclinometer, or at least one of a multi-axis accelerometer. The inclinometer sensor 508G can indicate the patient's relative position to a more global reference frame, such as the ground. For example, the inclinometer sensor 508G may indicate a 0-degree angle when the patient is upright relative to the ground (e.g., the patient is perpendicular to the ground) and a 90-degree angle when the patient is lying down (e.g., the patient is parallel to the ground). The inclinometer sensor 508G can indicate the patient's relative position to a local reference frame, such as an anatomical reference frame, which may include sagittal, coronal, and transverse planes. For example, the inclinometer sensor 508G can indicate a 0-degree angle when the patient is in a supine position (e.g., lying on their back) and a 180-degree angle when the patient is in a prone position (e.g., lying face down).
[0085] The detector device 508 may include a color / intensity sensor system 508H. The color / intensity sensor system may have an imaging system such as a visualization support device 509, such as a camera system 509E, and color / intensity processing software that operates on the CPU of the control circuit 230. In one example, the camera system 509E can perform visualization of a part of the eye 100, such as initial and subsequent visualizations that may include information on at least one of the indicators of color or color intensity, such as a digital image. The camera system 508E can digitize images, such as initial and subsequent digital images for processing, and transmit the digitized images to the control circuit 230, etc. By using at least one of a comparator circuit or color / intensity processing software, the difference in an indicator, such as at least one of the indicators of color or color intensity, between the initial digital image and the subsequent digital image can be identified, and the difference in the indicators can be stored using an electronic memory device, etc.
[0086] The detector device 508 may include a pressure sensor, such as a cavity pressure sensor 508I, to detect fluid pressure, such as in a sealed volume. The cavity pressure sensor 508I may include a sensing element that includes at least one of the following: a piezoelectric material, a piezoelectric resistance material, a capacitive material such as a Hall effect-based sensor, or a resistive material such as a strain gauge sensor.
[0087] The detector device 508 may include pressure sensors, such as a contact pressure sensor system 508J, to detect one or more surface pressures. The contact pressure sensor system 508J may have a contact transducer, such as at least one of piezoelectric, piezoelectric, capacitive, optical, potentiometric, or electromagnetic sensing elements, and a wireless signal interface, such as for supplying power to the contact transducer and detecting signals from the transducer. The contact pressure sensor 508J may include at least one of a strain sensor or a capacitive mat. The capacitive mat may have a first conductive member, a second conductive member adjacent to the first conductive member, and an insulating member, such as a dielectric, disposed between the first conductive member and the second conductive member. When the first conductive member approaches the second conductive member, such as due to the influence of opposing contact forces, such as forces generated between the sclera 122 and the orbit, a change in capacitance between the first conductive member and the second conductive member, such as a change proportional to the distance between the first conductive member and the second conductive member, can be detected. The contact pressure sensor system 508J can detect indicators of blood pressure, such as detecting indicators of contact pressure between two surfaces, such as force fluctuations caused by systolic and diastolic blood pressure. The contact pressure sensor system 508J can be placed between the sclera 122 and the orbit, for example, to detect orbital pressure. Orbital pressure may include one or more forces that the eye 100 exerts on the orbit due to blood pressure within the eye 100, such as those caused by systolic and diastolic blood pressure, which may change over time.
[0088] Figure 8 shows an example of a visualization support device 509 (or VAD) that may be provided with or can be used in combination with the device 200, such as to assist in the visualization of a patient's eye 100. The VAD 509 can visualize a portion of the eye, such as by varying fluid pressures within the housing, for example, to monitor indicators of ocular characteristics. The visualization may include representations of the physical structure, such as at least one of indicators of the physical structure of the patient's eye 100 or indicators of the ocular characteristics of the patient's eye 100, including images including analog or digital images. It is possible to not document the image, such as by allowing a human observer to perceive the image without saving it to computer memory or the like. It is also possible to document the image, such as by allowing an observer to perceive the image and save it to computer memory or the like, by using an imaging device such as the VAD 509.
[0089] The VAD509 may have a system that can receive images using a visualization detector and convert the received images into signals such as received electrical signals. The received electrical signals may include arrays of discrete values such as pixels and voxels that represent the received image, such as a digital image. The VAD509 can perform digital processing and other processing on the visualization of one or more images using an image processor circuit such as a VAD processor circuit incorporated into the VAD509.
[0090] VAD509 may include lenses or other devices to help a human observer visually detect indicators of ocular parameters, such as the cupid's-to-papillary ratio of a patient's eye 100. The observer can visually detect changes in indicators of physiological parameters, such as by comparing a first cupid's-to-papillary ratio of a patient's eye 100 as a result of a first gauge pressure applied to the patient's eye 100 by the device 200 with a second cupid's-to-papillary ratio of a patient's eye 100 as a result of a second gauge pressure applied to the patient's eye 100 by the device 200, for example, by evaluating changes in indicators of physiological parameters resulting from changes in pressure applied by the device 200. VAD509A may include one or more devices to improve the detection of indicators of ocular characteristics, such as at least one of a magnifying glass, such as a biomicroscope, or an ophthalmoscope, such as one with a light source.
[0091] The VAD509 may include a magnetic resonance imaging (MRI) system 509B. The MRI system 509B may include an MRI visualization detector, which may include one or more sensors capable of detecting radio frequency (RF) energy, such as energy in the frequency range of approximately 20 kilohertz to approximately 300 megahertz. The MRI system 509B can be used to generate two-dimensional or three-dimensional images of the eye.
[0092] VAD509 may include an ultrasonic system 509C. The ultrasonic system 509C may include an ultrasonic visualization detector, which may include one or more sensors, such as at least one of a piezoelectric transducer, a piezoelectric transceiver, or an array of piezoelectric transducers and transceivers, capable of detecting ultrasonic energy such as energy in the frequency range of about 20 kilohertz to about 10 gigahertz.
[0093] VAD509 may include an optical coherence tomography (OCT) system 509D. The OCT system 509D may include a visualization detector that includes one or more sensors, which may include at least one of a charge-coupled device (CCD) or a complementary metal-oxide-semiconductor (CMOS) element, to detect visible light, such as from an imaging target, and convert that light into an electrical signal, such as a pixel array suitable for electronic storage. For example, imaging of axonal transport is possible using the OCT system 509D. For example, an axonal transport imaging device may include the OCT system 509D. For example, a cribriform plate position / shape detection device may include the OCT system 509D. For example, the OCT system 509D, such as a phase-dispersive OCT system, can detect blood flow, such as changes in blood flow velocity within blood vessels.
[0094] VAD509 may include a camera system 509E. The camera system 509E may include at least one of a fundus camera, a video camera, or a smartphone camera such as a smartphone with video capture capabilities. For example, axonal transport imaging is possible by irradiating the retina of eye 100 with light at a wavelength of 490 nanometers, for example, using fluorescence angiography, and capturing the resulting image with the camera system 509E. For example, an axonal transport imaging device may include a camera system 509E.
[0095] VAD509 may include an X-ray system 509F, for example, to detect energy at one or more frequencies higher than visible light, such as in the frequency range above approximately 300 terahertz, and convert that energy into electrical signals, such as a pixel array suitable for recording. In one example, the imaging apparatus may include at least one of an X-ray computed tomography (X-ray CT) or computed axial tomography (CAT) system.
[0096] Figure 9 shows an example of how the device 200 is used, for example, to apply fluid pressure to an eye 100 within a cavity 212 of a goggle housing 210. 902 The device 200 can receive data that directly or indirectly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP. The received data can be detected from a patient, such as a patient wearing the device 200, which has a goggle housing 210 sized and shaped to rest on the orbit of an eye 100 so as to provide one or more cavities 212 extending around the entire exposed anterior portion of the eye 100 within the goggle housing 210. The device 200 can receive data in the control circuit 230, for example, via a data interface 232, from a detector device 508 or a storage device such as an electronic memory device.
[0097] In 904, the device 200 can control the pump 220, for example, to adjust the fluid pressure within the goggle housing 210, which is sized and shaped to be positioned above the patient's eye 100 without contacting the patient's eye 100, based on received data as a feedback control variable, in which case controlling the pump 220 may include further monitoring of received data for controlling the pump 220.
[0098] Receiving data that directly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, may include receiving an index of IOP detected by a fluid pressure sensor pre-implanted in the intraocular cavity of the eye, such as the direct IOP sensor system 508A, from a detector device 508 or the like. In one example, a manometer data receiver such as the camera system 509E can receive a first image of a first manometer level when there is a first pressure, and a second image of a second manometer level when there is a second pressure, using a CCD or CMOS element or the like. The camera system 508E can digitize the first and second images for processing and transmit the digitized first and second images to a control circuit 230 or the like. The difference between the first manometer level and the second manometer level may include an index such as a direct index of the detected IOP of eye 100, which is attributable to the second fluid pressure. In one example, a pressure transducer local interface can receive signals such as wireless signals from a pressure transducer, such as one implanted in the intraocular cavity of a patient's eye 100. The pressure transducer local interface can digitize the wireless signals for processing and transmit the digitized wireless signals to a control circuit 232 or the like. The wireless signals may include indicators such as direct indicators of the detected IOP of eye 100.
[0099] Receiving data that directly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, may include receiving an indicator of ICP detected by a fluid pressure sensor pre-implanted in fluid communication with the cerebrospinal region, such as a direct ICP sensor system 508B, from a detector device 508 or the like. In one example, the indicator acquisition device can receive signals such as wireless signals from an energized ICP sensor, such as one implanted in the ventricle of the patient's eye 100. The indicator acquisition device can digitize the wireless signal for processing and transmit the digitized wireless signal to a control circuit 230 or the like. The wireless signal may include indicators such as a direct indicator of the patient's detected ICP.
[0100] Receiving data that directly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, may include receiving an index of intraorbital pressure detected by a sensor pre-implanted in fluid communication with the orbit of the skull, such as a contact pressure sensor system 508J, from a detector device 508, etc. In one example, the contact pressure sensor system 508J may include a capacitive mat. A signal, such as a signal proportional to the orbital pressure, can be received via a wireless signal interface, digitized, and transmitted to the control circuit 230. The wireless signal may include an index such as a direct index of the patient's detected intraorbital pressure.
[0101] Receiving data indirectly indicating at least one of intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP may include receiving at least one of systemic blood pressure, hydrostatic pressure difference, or orbital pressure from a detector device 508, such as a sensor system including a wireless sensor and a wireless sensor receiver. The sensor system may include at least one of a blood pressure sensor system 508F and an inclinometer sensor system 508G. In one example, the wireless sensor receiver can receive signals such as wireless signals from wireless sensors in contact with the patient, such as the patient's skin. The wireless sensor receiver can digitize the wireless signals for processing and transmit the digitized wireless signals to a control circuit 230, etc.
[0102] Receiving data indirectly indicating at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, may include receiving an index of deviation from reference data, such as from VAD509. The index of deviation may include at least one of the following, such as ocular characteristics, transmembrane pressure difference (TPD) such as the cupping / papillary diameter ratio, SVP, venous evoked pulsation, or at least one of the shape or position of the cribriform plate, with reference to fixed data. The sensor system may include an OCT system 509D. In one example, the OCT system may receive an index of deviation by detecting reflected light. In one example, the OCT system 509D may emit light such as light of a specific wavelength and receive reflected light from a distant surface, such as at least one of a CCD or CMOS detector. The OCT system may digitize the detected reflected light and transmit the digitized signal to a control circuit 230, etc.
[0103] Receiving data that indirectly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, may include receiving indicators of physical parameters such as body mass index (BMI) and chronological age from a user, for example, to calculate estimates of intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP. In one example, the user interface (or UI) of the control circuit 230 may include a data input device such as a keypad to allow the control circuit 230 to receive data from a user. The received data may be stored in RAM or similar for purposes such as use in operating the device 200.
[0104] Receiving data indirectly may include receiving indicators of ocular vascular characteristics, including the diameter of the blood vessels, from a detector device 508 or the like, using an OCT system 509D. While the patient's eye 100 can receive the fluid pressure applied to the cavity 212 by the pump 220, the OCT system 509D can visualize a portion of the patient's eye 100, such as a portion containing at least one blood vessel, such as a venous vessel, through a goggle housing 210, such as a housing made of a light-transmitting material. Optical disturbances picked up by the goggle housing 210 can be mitigated by using a corrective lens, such as a corrective lens placed between the OCT system 509D and the goggle housing 210, a corrective lens placed between the goggle housing 210 and the patient's eye 100, or a corrective lens incorporated into the goggle housing 210.
[0105] The OCT system 509D can visualize changes in indicators of blood vessel diameter, such as changes in response to adjustments in the fluid pressure inside the goggle housing 210. By adjusting the fluid pressure inside the goggle housing 210, it is possible to cause deformation of blood vessels, such as dilation when the fluid pressure inside the goggle housing 210 is decreased and collapse when the fluid pressure inside the goggle housing 210 is increased. The OCT system 509D can perform visualizations such as visualization of one or more blood vessels, such as one or more visualizations performed while adjusting the fluid pressure inside the goggle housing 210, and can capture the representation of these visualizations as digital images.
[0106] The OCT system 509D can detect changes in indicators such as vascular diameter by comparing a first digital image of a portion of the patient's eye 100, which is the result of the first fluid pressure inside the goggle housing 210, with a subsequent digital image of a portion of the patient's eye 100, which is the result of the subsequent fluid pressure inside the goggle housing 210, when the first fluid pressure and the subsequent fluid pressure are different. Based on the changes detected in the vascular diameter indicator, the OCT system 509D can confirm criteria for changes in eye characteristics, such as vascular collapse, in the visualized patient's eye 100.
[0107] The analysis may include detecting changes, such as changes confirmed by comparing images, such as a first digital image resulting from a first fluid pressure and a subsequent digital image resulting from a subsequent fluid pressure, in cases where the subsequent fluid pressure is sufficient to initiate vascular collapse. Processing, such as image processing, may include using a comparator circuit. A comparator circuit can compare a first digital image and a subsequent digital image, such as corresponding array elements in the digital image, such as pixels or voxels. A comparator circuit can identify differences between a first digital image and a subsequent digital image, such as to confirm changes in vascular characteristics between the first and subsequent digital images.
[0108] Receiving data indirectly may include receiving indices of the transmembrane pressure difference (TPD), such as indices of the cupping / papillary diameter relationship, including the cupping / papillary diameter ratio, from a detector device 508 or the like. Visualization of the cupping / papillary diameter ratio can be received using a VAD 509, such as at least one of the following: an MRI system 509B, an ultrasound system 509C, an OCT system 509D, a camera system 509E such as a fundus camera or video camera or smartphone camera 509E, or an X-ray system 509F.
[0109] The cupping / papillary diameter ratio may indicate the relative magnitudes of IOP and ICP in the patient's eye 100, similar to the IOP to ICP ratio. The relationship between IOP and ICP can be evaluated by calibrating the cupping / papillary diameter ratio of each patient's eye 100, such as by changing the fluid pressure level applied in the device 200 and performing visualization of the eye 100 at the changing applied fluid pressure level. For example, by applying fluid pressure to the goggle housing 210 in gradual stages using the device 200, the fluid pressure inside the goggle housing 210 can be gradually increased or decreased, thereby changing the IOP of the patient's eye 100. Visualization of the cupping / papillary diameter ratio can be performed at each stage of the gradual fluid pressure using at least one VAD 509, and each visualization can be processed by saving the visualization to a memory device. Assuming that the ICP remains relatively constant during calibration, the cupid-to-papillary diameter ratio of each saved visualization can be identified, and based on the data acquired during calibration, the control circuit 230 or the like can process the ICP into a mathematical formula that relates it to the IOP, thereby allowing the relationship between the IOP and ICP, such as the cupid-to-papillary diameter ratio, to be identified from the progressive visualization of the patient's eye 100.
[0110] Controlling the pump 220 may involve setting the therapeutic pressure within the goggle housing 210, which may involve determining the amount or level of therapeutic pressure to be applied to the goggle housing 210 to treat ocular abnormalities. Determining the therapeutic pressure level may involve processing a received ocular characteristic index, receiving a target value for that ocular characteristic index, identifying the difference between the received ocular characteristic index and the target value for that ocular characteristic index, selecting a therapeutic pressure level based on the difference between the received ocular characteristic index and the target value for that ocular characteristic index, and transmitting a control signal to a device, such as the pump 220, that functions to supply the therapeutic pressure level to the goggle housing 210.
[0111] Processing the received ocular characteristic index may include assigning numerical values to the received ocular characteristic index. The numerical values of the received index may include values detected by a detector device 508 that has been calibrated with a calibration standard. For example, a received ocular characteristic index such as the IOP of eye 100 may include the IOP value detected by a detector device 508, such as a rebound tonometer, that has been calibrated with a calibration standard that includes at least one of a force standard or a displacement standard. The numerical values of the received ocular characteristic index may be weighted by the CPU of the control circuit 230, for example, by using numerical coefficients to convert the received index from a first parameter unit set to a second parameter unit set. In one example, the received indicator can be received in a first input channel of the control circuit 230 in a first set of parameter units such as millivolts or milliamperes, and the received indicator can be converted to a second set of parameter units such as pounds per square inch (psi) or millimeters of mercury (mmHg) by the CPU of the control circuit 230 by weighting it with a numerical coefficient that represents a conversion factor between the first set of parameter units and the second set of parameter units, such as mmHg / millivolts (mmHg / mv).
[0112] Processing received ocular characteristic indices may include calculating a composite index of ocular characteristics, such as a composite index that may include a function of one or more received indices. The composite index can be calculated using a processing unit such as the CPU of the control circuit 230. For example, a composite index of ocular characteristics, such as an estimated TPD index, can be calculated by checking the difference between a received IOP index and an estimated ICP index, such as an estimated ICP index that may be a function of a received blood pressure index and one or more indices of physical parameters such as BMI and chronological age.
[0113] Receiving target values for ocular characteristic indices may include receiving at least one target ocular parameter, such as one or more indicators of ocular characteristics, and one or more indicators of physical parameters from a medical professional prescribing the use of the device 200 to a patient, via the UI of the control circuit 230. For example, the target ocular parameters may include target values for the TPD of eye 100, such as target values in the range of approximately 2 mmHg to approximately 6 mmHg, including TPD target values of approximately 2 mmHg, approximately 3 mmHg, approximately 4 mmHg, approximately 5 mmHg, and approximately 6 mmHg. For example, the target values could include target values for 100 IOPs in each eye, such as target values in the range of approximately 10 mmHg to approximately 20 mmHg, including IOP target values of approximately 10 mmHg, 11 mmHg, 12 mmHg, 13 mmHg, 14 mmHg, 15 mmHg, 16 mmHg, 17 mmHg, 18 mmHg, 19 mmHg, and 20 mmHg. For example, the target values could include one or more indicators of the patient's physical parameters, such as BMI and patient age.
[0114] Receiving target values for ocular characteristic indicators may include calculating a composite target value for the ocular characteristic indicators based on the received target values, such as one or more ocular characteristic indicators and one or more indicators of the patient's physical parameters, using the CPU of the control circuit 230. For example, the composite target value for the TPD indicator can be calculated as a weighted sum of an ocular characteristic indicator such as blood pressure, one or more indicators of physical parameters such as body mass index (BMI) and patient age, and one or more experimental constants associated with one or more ocular characteristic indicators, including one or more experimental constants derived from a curve fitting algorithm.
[0115] Receiving target values for an ocular characteristic index may involve receiving a target value profile, such as a list of target values corresponding to discrete time points for one or more ocular characteristic indices. The magnitude of the received target values may change with respect to time, such as periodically or aperiodically. For example, the received target value profile may include a list of IOP target values, in which case the magnitude of the IOP target values changes periodically, such as in a circadian cycle or a cycle that repeats approximately every 24 hours.
[0116] Identifying the difference between a received ocular characteristic index and a target value of that index may involve linking the received index and the received target value using one or more mathematical operations, such as forming an error signal. The error signal can be used as a control signal, for example, to a pump 220 to set a gauge pressure, such as a therapeutic pressure level within the goggle housing 210. In one example, the error signal may include a value obtained by the CPU of the control circuit 230 by subtracting the value of the received target value from the value of the received index.
[0117] Mathematical operations may include any numerical, symbolic, or logical (e.g., Boolean) operations applied to one or more numbers or arrays of numbers, such as time-series values representing indicators of ocular characteristics. Numerical operations may include addition, subtraction, multiplication, division, weighting such as multiplying a number by a constant value to obtain a weighted value, and transformations by functions, such as converting a number to its logarithmic representation.
[0118] A device that functions to supply a therapeutic pressure level to the goggle housing 210, such as the pump 220, may have one or more operating characteristics, such as the power curve of an electric motor where the output (e.g., dependent variable) varies as a function of motor speed (e.g., independent variable). A control signal can be generated to incorporate the operating characteristics of the pump 220 in order to impart a therapeutic pressure level to the goggle housing 210, for example, by controlling the pump 220 using a control signal.
[0119] Selecting a therapeutic pressure level to be applied to the goggle housing 210 may include generating a control signal associated with the therapeutic pressure level, such as by calculating or identifying a control signal. Calculating a control signal may include applying one or more mathematical operations to one or more signals, such as an index of the received eye characteristics and an error signal. For example, the control signal may include linking the error signal to a function representing the operating characteristics of the pump 220 using one or more mathematical operations, such as to form a pump control signal.
[0120] Identifying control signals may involve comparing error signals to an array of control signal values, such as to identify control signals associated with therapeutic pressure levels. The array of control signal values may include a lookup table in which a functional relationship exists between independent variables, such as error signals, and dependent variables, such as control signals.
[0121] The functional relationship between the independent and dependent variables may include a linear function of the independent variable for generating a control signal. The linear function may include a combination of mathematical operations applied to at least one of one of one of the indices of ocular characteristics or one of one of one of the physical parameters, for example, when the dependent variable can be directly proportional to the independent variable. For example, to realize a pump control signal capable of operating pump 220 to supply the therapeutic pressure level necessary to treat the ocular symptoms of eye 100, the error signal can be multiplied by a system gain, such as a gain proportional to an indice of the ocular characteristic.
[0122] The functional relationship between the independent and dependent variables may include a nonlinear function of the independent variable for generating a control signal. The nonlinear function may include a combination of mathematical operations applied to one or more indicators of ocular characteristics or at least one of one or more physical parameters, such as when the dependent variable may be inversely proportional to the independent variable. The nonlinear function may also include a combination of mathematical operations applied to one or more indicators of parameters independent of the patient, such as the operating characteristics of a device, including frequency-domain and time-domain characteristics of the device operation. For example, to realize a control signal capable of operating pump 220 to supply the therapeutic pressure level necessary to treat the ocular symptoms of eye 100, the error signal can be weighted by a nonlinear function or parameter, such as a function or parameter describing the operating characteristics of pump 220, where the gauge pressure generated by pump 220 may depend on the speed of pump 220.
[0123] Transmitting an indicator of the therapeutic pressure level may involve transmitting a control signal to a device, such as a device that functions to supply a therapeutic pressure level to the goggle housing 210, via an output channel of the control circuit 230, such as a first output of the control circuit 230. In one example, the first output of the control circuit 230 may be electrically connected to the pump 220 so that the pump 220 can receive pump control signals to set or generate and control the gauge pressure supplied to the goggle housing 210. In one example, the first output of the control circuit 230 may be electrically connected to one or more valve assemblies, such as an electric valve assembly including a controllable vent and an electric venturi valve assembly, which includes one or more pressurized fluid sources, such as a fluid source that confines positive or negative gauge pressure, connected to the goggle housing 210 via the valve assembly.
[0124] Setting the therapeutic pressure within the goggle housing 210 may include applying a therapeutic pressure to the goggle housing 210 to treat ocular symptoms such as ocular abnormalities. The therapeutic pressure can be generated by a pressure source such as a pump 220 and applied to the cavity 212 of the goggle housing 210, such as by generating gauge pressure within the goggle housing 210 to treat ocular symptoms of eye 100. The applied therapeutic pressure may include gauge pressure, such as positive or negative gauge pressure applied to the goggle housing 210. The gauge pressure can be generated on demand by a pump 220 or the like, or supplied by one or more pressurized fluid sources such as a pressurized gas cylinder containing a control valve such as a pressure regulator for measuring the gauge pressure applied to the goggle housing 210.
[0125] Setting the therapeutic pressure within the goggle housing 210 may include determining the duration of the therapeutic pressure applied to the cavity 212 to treat the ocular symptoms of eye 100. The duration of the applied therapeutic pressure may depend on the ocular symptoms being treated by that pressure. For example, determining the duration of the applied therapeutic pressure may include identifying the ocular symptoms of eye 100 requiring treatment and prescribing the duration of the therapeutic pressure applied to the cavity 212. Prescribing the duration of the therapeutic pressure may include defining the length of time the therapeutic pressure is applied to the cavity 212.
[0126] Further monitoring of received data for controlling the pump may involve adjusting the therapeutic pressure, such as within the goggle housing 210. Adjusting the therapeutic pressure may involve enhancing the effect of the applied therapeutic pressure, which may include changing the level of therapeutic pressure applied to the goggle housing 210 to minimize the difference between an index of one or more received feedback signals and a target value of a received physiological parameter. Adjusting the therapeutic pressure to be applied to the eye 100 may involve using a feedback control principle, such as a closed-loop control principle, implemented using an algorithm executed on the CPU of the control circuit 224, to adjust the level of therapeutic pressure applied to the goggle housing 210.
[0127] Adjusting the therapeutic pressure within the goggle housing 210 may involve detecting one or more feedback signals from a patient wearing the device 200. These one or more feedback signals may include information about pressure indices, including indicators of physiological parameters, and indicators of therapeutic pressure levels applied to the goggle housing 210, as detected by one or more detectors 513. The device 200 can receive information about one or more feedback signals in the control circuit 224, for example, by receiving one or more feedback signals through one or more input channels of the control circuit 224.
[0128] Adjusting the therapeutic pressure level within the goggle housing 210 may involve processing one or more feedback signals. Processing feedback signals may involve calculating a composite index of physiological parameters, for example, when the composite index may be a function of one or more feedback signals.
[0129] Adjusting the therapeutic pressure level within the goggle housing 210 may include receiving updated target values for a feedback signal, such as updated target values for one or more indicators of physiological parameters and one or more indicators of the patient's physical parameters. The updated target values can be received from the user of the device 200, for example, via the UI of the control circuit 224. Receiving the updated target values may further include the CPU of the control circuit 224 calculating an updated composite target value for the feedback signal based on the received updated target values.
[0130] Adjusting the therapeutic pressure level within the goggle housing 210 may include identifying the difference between the feedback signal and the target value of the received feedback signal, such as in order to form an updated error signal.
[0131] Adjusting the treatment pressure level may include selecting an updated treatment pressure based on an updated error signal, and transmitting the updated control signal, such as an updated pump control signal, to a device such as a pump 220 that functions to supply the updated treatment pressure to the goggle housing 210.
[0132] Adjusting the fluid pressure, such as the fluid pressure level 503, may include generating a pump signal 501 in response to the detected eye parameter signal 502. The detected eye parameter signal can be detected by performing visualization of the central retinal vein 133 displaying the SVP, and by analyzing the visualizations, such as analyzing the initial and subsequent visualizations of the SVP to identify changes in at least one eye characteristic or other physiological characteristic, such as a change in inner diameter due to the SVP, between the initial and subsequent visualizations. Visualization can be performed using a VAD 509 such as an OCT system 509D. Based on the detected eye parameter signal 502, such as a change in inner diameter due to the SVP, the control circuit can generate a pump signal 501, such as an adjusted pump signal, which may be in phase with or out of phase with the detected eye parameter signal 502. In one example, a pump signal 501, such as an in-phase pump signal 501, can generate a fluid pressure level 503, such as an in-phase fluid pressure level 503, which can be applied to the goggle housing 210 to minimize the dynamic component of the TMP. For example, a pump signal 501, such as an out-of-phase pump signal 501, can generate a fluid pressure level 503, such as an out-of-phase fluid pressure level 503, which can be applied to the goggle housing 210 to maximize the dynamic component of the TMP.
[0133] Controlling the pump 220 may include processing the received data by a control circuit 230 or the like. The received data may include a composite signal 513 that includes at least one of the following: the detected eye parameter signal 510, the target eye parameter signal 512, or the housing sensor signal 507.
[0134] Controlling the pump 220 may include transmitting an indicator 501 of the processed synthetic data to the pump 220. The indicator 501 of the processed synthetic data can be transmitted by an electrical connection, such as at least one of a wired or wireless connection between the control circuit 230 and the pump 220. The pump 220 can receive an indicator 201 of the processed data, such as by an electrical interface, such as at least one of a wired or wireless interface between the control circuit 230 and the pump 220.
[0135] Figure 10 shows an example of how the device 200 is used to apply pressure to the eye 100 for monitoring ICP. 1006 In the imaging device or other visualization support device 509, a portion of the eye 100 can be visualized, such as at various different fluid pressures within the goggle housing 210, for monitoring ICP indicators.
[0136] Figure 11 shows an example of a method 1100 of using the device 200 to apply pressure to the eye 100, such as to identify or monitor the ICP. 1208, initial visualization of the patient's eye 100 can be performed at a first fluid pressure, for example, by using a goggle housing 210 that is sized and shaped to be positioned above the patient's eye 100 without contact with the patient's eye 100.
[0137] At 1110, subsequent visualization of the patient's eye 100 can be performed at a subsequent fluid pressure, such as a subsequent fluid pressure that may differ from the first fluid pressure. Subsequent visualizations may include visualizations performed after the initial visualization, such as a second visualization, a third visualization, a fourth visualization, a fifth visualization, or other visualizations.
[0138] In 1112, initial and subsequent visualizations can be used to identify changes in at least one ocular characteristic, such as changes in the fluid pressure between a first and a second fluid pressure within the housing. Ocular characteristics may include changes in the diameter of blood vessels, such as blood vessels in the ocular cavity, including venous vessels, or blood vessels in the patient's eye 100, such as episcleral venous vessels. Ocular characteristics may include vascular conditions, such as collapse of intraocular venous vessels, resulting from the fluid pressure applied to the cavity 212 of the goggle housing 210. For example, an ocular characteristic change criterion may include collapse of intraocular venous vessels, resulting from the fluid pressure applied to the cavity 212 of the goggle housing 210.
[0139] Implementing visualization may include selecting a VAD509, such as a VAD509, to achieve the objective of examining the patient's eye 100. Implementing visualization may also include selecting one or more detector devices 508, such as for use in combination with the VAD509, to achieve at least one of identifying or monitoring eye characteristics.
[0140] Identifying changes in at least one ocular characteristic may include processing the visualization using processing techniques. Processing techniques may include manually processing at least one visualization, such as by observing the visualization with the observer's eyes.
[0141] Observing visualizations may include perceiving undocumented images of the patient's eye 100, such as when an observer observes the patient's eye 100, and evaluating the eye 100 through inferences based on the observation of the undocumented images. For example, processing visualizations may include an observer, such as an ophthalmologist, observing the patient's eye 100, such as using an ophthalmoscope to visualize ocular characteristics, including the cupping / disk diameter ratio of the optic nerve 118, in order to check for indicators of possible abnormalities in the patient's eye 100, such as a cupping / disk diameter ratio that may differ from a ratio of 0.3.
[0142] Observing the visualization may involve perceiving one or more undocumented images of the patient's eye 100, such as detecting a change in at least one ocular characteristic between an initial undocumented image and a subsequent undocumented image. For example, processing the visualization may involve placing the device 200 over the patient's eye 100, applying a first fluid pressure to the cavity 212 of the goggle housing 210, visualizing ocular characteristics of the patient's eye 100, such as the cupid / papillary ratio as a result of the first fluid pressure, applying a second fluid pressure to the cavity 212, such as a second fluid pressure different from the first fluid pressure, visualizing ocular characteristics, such as the cupid / papillary ratio as a result of the second fluid pressure, and detecting a change in the cupid / papillary ratio as a result of the first and second undocumented images, such as the first and second undocumented images.
[0143] The processing technique may include digitally processing at least one visualization, such as by observing the visualization using a VAD509, which has the ability to store digital images.
[0144] Observing visualizations may include perceiving documented images of the patient's eye 100 using a VAD509 or similar device capable of storing digital images, and evaluating the eye 100 through inferences based on observation of the documented images. For example, processing visualizations may include an observer, such as an ophthalmologist, observing documented images of the patient's eye 100, such as the cupping / optic disc diameter ratio of the optic nerve 118, to check for indicators of possible abnormalities in the patient's eye 100, such as a cupping / optic disc diameter ratio that may differ from a ratio of 0.3.
[0145] Observing the visualization may involve perceiving one or more documented images of the patient's eye 100, such as detecting a change in at least one ocular characteristic between an initial documented image and a subsequent documented image. For example, processing the visualization may involve placing the device 200 over the patient's eye 100, applying a first fluid pressure to the cavity 212 of the goggle housing 210, visualizing ocular characteristics of the patient's eye 100, such as the cupid / papillary diameter ratio as a result of the first fluid pressure, applying a second fluid pressure to the cavity 212, such as a second fluid pressure different from the first fluid pressure, visualizing ocular characteristics, such as the cupid / papillary diameter ratio as a result of the second fluid pressure, in a second image, and detecting a change in the cupid / papillary diameter ratio as a result of the first and second fluid pressures, such as observing the change between the first and second images, such as the first and second digital images.
[0146] The analysis may include observing changes, such as between a first and second digital image. Observing changes may include manually processing the first and second digital images, such as identifying changes in indicators of ocular characteristics. Manual processing may include the visual detection of changes between the first and second digital images by an observer, such as changes between at least one of the pixel characteristics or voxel characteristics in the corresponding digital elements. Detecting changes may include the visual perception of the first digital image, the perception of the second digital image, and the identification of differences between the first and second digital images by an observer.
[0147] Observing changes between a first and second digital image may involve digitally processing the first and second digital images, such as to identify changes in indicators of eye characteristics. Digitally processing the first and second images may involve using a computing device to detect changes between the first and second digital images, such as changes between at least one of the pixel characteristics or voxel characteristics in the corresponding digital elements. Detecting changes may involve storing representations of the first and second digital images in the memory of a computing device, such as random access memory or RAM, and executing an algorithm, such as a digital comparator algorithm, to identify the differences between the first and second digital images. Executing an algorithm may involve invoking software code, such as software code implemented in the computing device, and applying the instruction set of the software code to the representations of the first and second digital images.
[0148] Figure 12 shows an example of how the device 200 can be used to identify ICP indicators, etc. In 1202, the initial visualization of the patient's eye 100 can be performed with a first fluid pressure in one or more cavities 212 of a goggle housing 210 that is sized and shaped to be placed over the patient's eye 100 without contact with the patient's eye 10, and the visualization is performed with the goggle housing 210 placed over the patient's eye 100.
[0149] In 1204, subsequent visualization of the patient's eye 100 can be performed using the subsequent fluid pressure in one or more cavities 212 of the goggle housing 210, with the goggle housing 210 positioned over the patient's eye 100, and the subsequent fluid pressure is different from the first fluid pressure.
[0150] In 1206, initial and subsequent visualizations can be used to identify changes in at least one visual or other physiological characteristic corresponding to the change between the first fluid pressure and the subsequent fluid pressure within the housing.
[0151] Figure 13 shows an example of how the device 200 can be used to synchronize the pressure applied to the goggle housing 210 with the patient's cardiac cycle. 1308 The fluid pressure in one or more cavities of the goggle housing 210 can be adjusted to correspond to one or more parts of the patient's cardiac cycle.
[0152] Figure 14 shows an example of a method 1400 using the device 200 to identify ICP based on indicators of the patient's cardiac cycle. In 1410, the initial and subsequent visualizations can be analyzed to identify indicators of intracellular pressure based on changes in at least one ocular or other physiological characteristic between the initial and subsequent visualizations.
[0153] Figure 15 shows an example of method 1500, such as using the device 200 to perform a diagnostic examination of the eye 100 after the completion of a treatment session. Method 1500 may include examples of using the device 200 by combining diagnostic and therapeutic methods, such as monitoring and treating at least one of acute or chronic eye abnormalities.
[0154] In 1502, the gauge pressure can be released from the goggle housing 210, which is sized and shaped to be positioned above the patient's eye 100 without contact with the eye. In 1504, visualization of the patient's eye 100 can be performed using atmospheric fluid pressure within the goggle housing 210, and this visualization is performed with the goggle housing 210 positioned over the patient's eye 100 to detect eye characteristics that meet eye characteristic recovery criteria. In one example, eye characteristic recovery criteria may include recovery to an ambient cross-sectional shape such as the approximately circular shape of the central retinal vein 133.
[0155] In 1506, gauge pressure can be applied to the goggle housing 210 to achieve the ocular characteristic change criterion. In one example, the ocular characteristic change criterion may include collapse of intraocular venous vessels, such as that caused by fluid pressure applied to the cavity 212 of the goggle housing 210.
[0156] Applying gauge pressure, such as positive or negative gauge pressure, to the patient's eye 100 may cause deformation in the patient's eye 100, such as compression due to positive gauge pressure or expansion due to negative gauge pressure, to exhibit a deformed state. A brief deformation of the patient's eye 100, such as deformation induced using the device 200 in a diagnostic examination, may cause a change in the ocular properties of the patient's eye 100, such as a transient change in the ocular properties of the patient's eye 100 relative to the basic ocular properties. The basic ocular properties, such as a first set of basic ocular properties, may include ocular properties detected from the patient's eye 100 in a relaxed state when no gauge pressure is applied to the patient's eye 100, such as ocular properties detected at ambient pressure or atmospheric pressure.
[0157] Prolonged deformation of the patient's eye 100, such as deformation induced during the therapeutic use of the device 200 on the patient's eye 100, may result in remodeling or other adaptations of the patient's eye 100 to the applied fluid pressure, such as inducing permanent changes in ocular properties that permanently alter the first set of basic ocular properties of the patient's eye 100. In other words, remodeling of the patient's eye 100, such as that resulting from prolonged deformation of the patient's eye 100 due to the use of the device 200, causes the patient's eye 100 to assume a second set of basic ocular properties, which differ from the first set of basic ocular properties.
[0158] For evaluating a patient's eye 100, such as determining the effectiveness of a treatment regimen, it may be effective to perform diagnostic tests on the patient's eye 100 in a flaccid state. The time it takes for a patient's eye 100 to transition from a deformed state to a flaccid state may vary depending on the patient's physiological function, etc.
[0159] Releasing gauge pressure from the goggle housing 210 may involve exposing the patient's eye 100 to ambient pressure so that the patient's eye 100 can recover from a deformed state to a relaxed state. Ambient pressure may include at least one of atmospheric pressure or fluid pressure unaffected by the pump 220. Gauge pressure can be released via a controllable vent by opening the controllable vent, for example, by providing a low-resistance fluid path to equalize the fluid pressure difference between the goggle housing 210 and the ambient atmosphere. Gauge pressure can also be released by turning off the pump 220 to allow bleed-off of gauge pressure within the goggle housing 210, for example, by providing a variable-resistance fluid path to equalize the fluid pressure difference between the goggle housing 210 and the ambient atmosphere.
[0160] Detecting ocular characteristics that meet the criteria for ocular characteristic recovery may include visualizing a portion of the patient's eye 100, such as a portion of the patient's eye 100 containing an indicator of ocular characteristics, and observing that visualization, for example, to compare the ocular characteristics with the criteria for ocular characteristic recovery. For example, an ocular characteristic such as the inner diameter of the central retinal vein 133 deformed by the gauge pressure inside the goggle housing 210 of the device 200 can be visualized using an OCT system 509D while the gauge pressure is being released from the goggle housing 210, and can be compared with an ocular characteristic recovery criterion such as the inner diameter of the central retinal vein 133 in a relaxed state.
[0161] Releasing the gauge pressure may include visualizing eye 100 after the criteria for recovery of eye characteristics of eye 100 have been achieved. For example, in the case of a patient's eye 100 in a relaxed state, the patient's eye 100 can be visualized to detect indicators of eye characteristics.
[0162] The inner diameter of the central retinal vein 133 in a relaxed state can be determined by measuring the inner diameter of the central retinal vein 133 in a relaxed state, such as in the eye 100 of a patient under atmospheric conditions, or by calculating an estimate of the inner diameter of the central retinal vein 133. Calculating an estimate of the inner diameter of the central retinal vein 133 may include visualizing the central retinal vein 133 under gauge pressure applied by the device 200, such as a gauge pressure sufficient to collapse the central retinal vein 133; detecting the inner diameter of the central retinal vein 133 in a deformed state, such as a collapsed state; and calculating an estimate of the inner diameter of the central retinal vein 133 in a relaxed state. Calculating an estimate of the inner diameter of the central retinal vein 133 in a relaxed state may involve dividing the inner diameter of the central retinal vein 133, as detected in a collapsed state, by a mathematical constant known as pi (π), and multiplying the estimated radius by 2 to obtain an estimate of the inner diameter of the central retinal vein 133 before deformation.
[0163] Setting treatment pressure may involve identifying ocular symptoms in eye 100, such as ocular abnormalities, for the purpose of prescribing a treatment regimen for ocular symptoms. The presence of ocular abnormalities can be identified by evaluating one or more indicators of ocular properties, such as TPD, in eye 100. Indicators of TPD may include the optic disc cupping / disk diameter ratio. Eye 100 with a cupping / disk diameter ratio of approximately 0.3 may indicate "normal" TPD in eye 100, such as eye 100 with physiologically normal function. Eye 100 with a cupping / disk diameter ratio lower or higher than approximately 0.3 may indicate "abnormal" TPD, such as eye 100 that does not have physiologically normal function, such as eye 100 that requires treatment.
[0164] A cupping / disk diameter ratio higher than approximately 0.3 may indicate the presence of ocular abnormalities such as glaucoma. For example, cupping / disk diameter ratios in the range of approximately 0.35 to 0.9, such as approximately 0.35, 0.4, 0.5, 0.6, 0.7, 0.8, and 0.9, may indicate the presence of ocular abnormalities including glaucoma. A cupping / disk diameter ratio lower than approximately 0.3 may indicate the presence of ocular abnormalities such as optic disc edema. For example, if no cupping is observed at optic disc 150, as indicated by cupping / disk diameter ratios of approximately 0.25, 0.2, 0.15, 0.1, 0.05, and a cupping / disk diameter ratio of approximately 0.00, it may indicate optic disc edema and other ocular abnormalities including disc edema.
[0165] Figure 16 shows an example of a method 1600 for identifying at least one of ICP or IOP using the device 200 for diagnostic purposes. 1602 The device 200 can be placed on a patient, such as a patient suspected of having an ocular abnormality.
[0166] In 1604, a visualization support device 509 can be selected, for example, to visualize at least a portion of the patient's eye 100. The VAD 509 can be selected based on whether IOP, ICP, or both should be measured.
[0167] At 1606, visualization can be performed in the patient's eye 100, such as the initial visualization at a first fluid pressure. The device 200 can record metadata, including the applied pressure. The initial image may include a base image, such as an image that can be compared with other images to detect changes in ocular characteristics.
[0168] In 1608, visualizations can be performed, such as a second visualization at a second fluid pressure. The second fluid pressure may differ from the first fluid pressure. In 1610, the first and second visualizations can be used to identify changes in at least one ocular or other physiological characteristic corresponding to the change between the first and second fluid pressures within the housing.
[0169] In 1612, changes in ocular characteristics can be compared to at least one change criterion, for example, to determine whether a change criterion has been met. In 1614, the second visualization can be renamed the first visualization, and subsequent visualizations can be obtained until the criteria for changes in ocular characteristics are met.
[0170] Figure 17 shows an example of a method 1700 of using the device 200 for therapeutic purposes, including treating at least one of acute or chronic eye abnormalities. In 1702, the device 200 can be placed on the patient, such as a patient diagnosed with an eye abnormality.
[0171] At 1704, the detected eye parameter signal 510 can be received via the data interface 232. In 1706, the detection eye parameter signal 510 can be processed by the control circuit 230, for example, to form a pump control signal 501. Processing may include comparing a first fluid pressure index with a setpoint, for example, to calculate an error signal. The pump control signal 501 may include a pump signal, such as a pump signal that reduces the error signal by a predetermined percentage.
[0172] In step 1708, the pump 220 can receive a pump control signal 501, for example, to adjust the fluid pressure supplied to the goggle housing 210 from a first pressure to a second pressure different from the first pressure.
[0173] With the 1710, the fluid pressure inside the goggle housing 210 can be monitored, for example, to bring the error signal to zero. With 1712, the error signal can be kept at zero over clinically significant periods.
[0174] Figure 18 shows an exemplary method 1800 for setting and adjusting therapeutic pressure applied to the eye 100 using IOP, such as for the treatment of ocular abnormalities. In 1802, the patient can wear the device 200 by positioning the goggle housing 210 over the patient's eye 100 from above so that the goggle housing 210 is in contact with the patient's skin, such as to form a hermetic seal between the goggle housing 210 and the patient's skin.
[0175] In 1804, information regarding pressure indicators, such as physiological parameter indicators including IOP, can be detected using a detector 513 including an internal detector 513b. In step 1806, the IOP indicator can be received by the control circuit 224, for example, on the first input channel of the control circuit 224.
[0176] In step 1808, the difference between the received IOP index and the IOP target value, such as the IOP target value received via the UI attached to the control circuit 224, can be identified by the CPU attached to the control circuit 224. The difference between the received IOP index and the IOP target value may be a signal such as an error signal.
[0177] In 1810, a pump command signal can be selected based on an error signal or the like, and transmitted from the CPU to another device, such as the pump 220, via one or more output channels of the control circuit 224, to control the operation of that device.
[0178] In 1812, the pump 220 can respond to receiving a pump command signal from one or more output channels of the control circuit 224 by operating the pump to generate therapeutic pressure to be applied to the goggle housing 210 of the device 200.
[0179] In 1814, therapeutic pressure can be applied to the goggle housing 210 in order to generate a therapeutic pressure level within the cavity 212 for treating eye symptoms, etc. In 1816, changes in physiological parameters such as IOP in response to the application of therapeutic pressure can be detected by a detector 513, such as an internal detector 513b. Changes in IOP may be feedback signals, such as an IOP feedback signal.
[0180] With 1818, the IOP feedback signal can be received by the control circuit 224, such as on the first input channel of the control circuit 224. In step 1820, the difference between the IOP feedback signal and the updated IOP target value, such as the IOP target value, can be determined using the CPU attached to the control circuit 224. The difference between the IOP feedback signal and the updated IOP target value may be a signal such as the updated error signal.
[0181] In 1822, an updated pump command signal can be selected, for example, based on the updated error signal, and transmitted from the CPU to other devices, such as the pump 220, via one or more output channels of the control circuit 224, to correct the operation of those devices.
[0182] In 1824, the pump 220 can respond to the receipt of an updated pump command signal by activating the pump to generate updated therapeutic pressure to be applied to the goggle housing 210 of the device 200.
[0183] [Various notes] To further illustrate the apparatus and methods of this disclosure, a non-limiting list of examples is provided below.
[0184] Embodiment 1 may encompass or employ a subject such as an apparatus for the diagnosis or treatment of at least one of ocular symptoms. The subject may include a goggle housing sized and shaped to rest on the orbit of an eye, providing within the housing one or more cavities extending around the entire exposed anterior portion of the eye; a pump in fluid communication with one or more cavities to impart fluid pressure to one or more cavities, configured to regulate the fluid pressure within one or more cavities of the goggle housing; and a control circuit having a data interface for receiving data directly or indirectly indicating at least one of intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, and controlling the pump to regulate the fluid pressure within one or more cavities based on processing the received data as a feedback control variable, wherein the control includes using further monitoring of the received data to control the pump.
[0185] Example 2 may encompass the subject matter of Example 1, or may optionally combine it with that subject matter, and optionally includes a data interface attached to the control circuit to receive data that directly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, the data to be received including at least one of the following indicators: IOP detected by a pressure sensor pre-implanted in the intraocular cavity of the eye, ICP detected by a sensor pre-implanted in fluid communication with the cerebrospinal region, or intraorbital pressure detected by a sensor pre-implanted in fluid communication with the orbit of the skull.
[0186] Example 3 may encompass or optionally combine with the subject matter of Example 1 or 2, and optionally includes a control circuit data interface for receiving data indirectly indicating at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, the data to be received including at least one of the following indicators: ocular vascular characteristics, intermembrane pressure difference including cupping / papillary diameter relationship, systemic blood pressure, body parameters including body mass index (BMI), hydrostatic pressure difference corresponding to various different body positions or postures, spontaneous or induced venous pulsation, cribriform or position of the cribriform plate, episcleral venous pressure, or orbital pressure.
[0187] Example 4 may encompass the themes of Examples 1-3, or may be optionally combined with them, and optionally includes a visualization support device for visualizing a portion of the eye at various different fluid pressures within a housing in order to monitor ICP indicators.
[0188] Example 5 may encompass the themes of Examples 1 to 4, or may optionally combine them, and may optionally include a visualization support device, which is configured to acquire an index of the indentation / nipple diameter ratio.
[0189] Example 6 may encompass the themes of Examples 1 to 5, or may optionally combine them, and may optionally include a visualization support device to provide at least a portion of the above data, the visualization support device including a fundus camera.
[0190] Example 7 may encompass the themes of Examples 1 to 6, or may optionally combine them, and may optionally include a visualization support device to provide at least a portion of the above data, the imaging device including an optical coherence tomography (OCT) system.
[0191] Example 8 may encompass the themes of Examples 1 to 7, or may optionally combine them, and optionally includes a blood pressure sensor to provide at least a portion of the above data.
[0192] Example 9 may encompass the themes of Examples 1 to 8, or may be optionally combined with them, and may optionally include a detector device to provide at least a portion of the above data by detecting a change in at least one of the following: vascular dimensions, flow characteristics, pulsation, oxygenation, or color characteristics.
[0193] Example 10 may encompass the themes of Examples 1 to 9, or may optionally combine them, and optionally includes a hydrostatic pressure difference sensor, including an inclinometer or attitude sensor, to provide at least a portion of the above data.
[0194] Example 11 may encompass the themes of Examples 1 to 10, or may optionally combine them, and optionally includes a tonometer to provide at least some of the above data, wherein the tonometer is integrated or coupled to a housing so that the tonometer can access the eye.
[0195] Example 12 may encompass the themes of Examples 1 to 11, or may optionally combine them, and optionally includes a contact lens to provide at least a portion of the above data, the contact lens having a strain sensor or other sensor incorporated for detecting eye characteristics.
[0196] Example 13 may encompass the themes of Examples 1 to 12, or may be optionally combined with them, and optionally includes an axonal transport imaging device to provide at least a portion of the above data.
[0197] Example 14 may encompass the themes of Examples 1 to 13, or may be optionally combined with them, and optionally includes a sieve plate position / shape detection device to provide at least a portion of the above data.
[0198] Example 15 may encompass or optionally combine with the themes of Examples 1 to 14, and optionally the data interface includes receiving and processing ICP indices obtained by performing an initial visualization of the patient's eye at a first fluid pressure within a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, performing visualization with the goggle housing positioned above the patient's eye; performing one or more subsequent visualizations of the patient's eye at one or more subsequent fluid pressures within the goggle housing, performing visualization with the goggle housing positioned above the patient's eye at a subsequent fluid pressure different from the first fluid pressure; and using the initial and subsequent visualizations to identify a change in at least one eye characteristic corresponding to the change between the first fluid pressure and the subsequent fluid pressure within the housing.
[0199] Example 16 may encompass or employ a subject such as an apparatus for the diagnosis or treatment of an ocular condition. The subject may include a goggle housing sized and shaped to rest on the orbit of an eye, providing within the housing one or more cavities extending around the entire exposed anterior portion of the eye; a pump in fluid communication with one or more cavities to impart fluid pressure to one or more cavities, configured to regulate the fluid pressure within one or more cavities of the goggle housing; and a visualization support device for visualizing at least a portion of a patient's eye when the goggle housing is in contact with and resting on the patient, the visualization support device communicating with the pump to regulate the fluid pressure within the cavities of the goggle housing at that time.
[0200] Example 17 may encompass the subject matter of Example 16, or may optionally combine it with that subject matter, and optionally includes a control circuit that controls a pump to adjust the fluid pressure in one or more cavities of one or more cavities of a goggle housing for visualization using a visualization support device.
[0201] Example 18 may encompass or optionally combine with the subject matter of Example 16 or 17, and optionally includes performing an initial visualization of a patient's eye at a first fluid pressure in one or more cavities of a goggle housing, and performing one or more subsequent visualizations of the patient's eye at one or more subsequent fluid pressures in the goggle housing, with the goggle housing positioned over the patient's eye, and using the initial and subsequent visualizations to identify a change in at least one eye characteristic corresponding to a change between the first fluid pressure and the subsequent fluid pressure in the housing, wherein the control circuit is configured to control a pump to adjust the fluid pressure in one or more cavities.
[0202] Example 19 may encompass the themes of Examples 16 to 18, or may optionally combine them, and optionally includes a visualization support device that includes an optical coherence tomography (OCT) device.
[0203] Example 20 may encompass the themes of Examples 16 to 19, or may optionally combine them, and optionally the visualization support device may include a fundus camera.
[0204] Example 21 may encompass the themes of Examples 16 to 20, or may optionally combine them, and optionally the visualization support device may include an ultrasonic imaging device.
[0205] Example 22 may encompass the themes of Examples 16 to 21, or may optionally combine them, and optionally, the visualization support device may include, or be coupled to, an image processor circuit for analyzing the first and subsequent visualizations to identify a change in at least one ocular or other physiological characteristic between the first and subsequent visualizations.
[0206] Example 23 may encompass or optionally combine with the themes of Examples 16-22, optionally including an image processor circuit configured to compare pixels or voxels associated with images of blood vessels between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing to identify changes in blood flow velocity.
[0207] Example 24 may encompass or optionally combine with the themes of Examples 16-23, optionally including an image processor circuit configured to compare pixels or voxels associated with an image of a blood vessel to identify changes in the color characteristics associated with the blood vessel between an initial visualization and a subsequent visualization at different applied pressures within one or more cavities of the housing.
[0208] Example 25 may encompass or optionally combine with the themes of Examples 16-24, optionally including a configuration in which the image processor circuit determines whether changes in ocular characteristics or other physiological characteristics between the initial visualization and the subsequent visualization indicate that a defined vascular diameter change criterion or other defined criterion is met.
[0209] Example 26 may encompass or optionally combine with the themes of Examples 16-25, optionally including the configuration of an image processor circuit to identify an index of internal pressure based on changes in ocular or other physiological characteristics between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing.
[0210] Example 27 may encompass or optionally combine with the themes of Examples 16-26, optionally including a configuration in which the image processor circuit correlates cerebrospinal fluid (CSF) pressure to an index of internal pressure based on changes in ocular or other physiological characteristics between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing.
[0211] Example 28 may encompass the themes of Examples 16-27, or may optionally combine them, and optionally the visualization support device includes, or is coupled to, an image processor circuit for analyzing the first and subsequent visualizations to identify a change in at least one ocular or other physiological characteristic between the first and subsequent visualizations, wherein the at least one ocular or other physiological characteristic includes at least one of the amplitude, vascular diameter, location, or other characteristics of a spontaneous or induced venous pulse.
[0212] Example 29 may encompass or optionally combine with the themes of Examples 16-28, optionally including a control circuit configured to actuate a pump to adjust the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's ocular pulse wave period.
[0213] Example 30 may encompass or optionally combine with the themes of Examples 16-29, optionally including a control circuit configured to actuate a pump to adjust the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's ocular pulse wave period.
[0214] Example 31 may encompass or optionally combine with the themes of Examples 16-30, and optionally includes a control circuit configured to operate a pump to adjust the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's cardiac cycle over multiple cardiac cycles, thereby changing (maximizing, minimizing, or mediating) the amplitude or other characteristics of vascular spontaneous pulses, venous induced pulses, or other ocular or other physiological characteristics over multiple cardiac cycles.
[0215] Example 32 may encompass or optionally combine with the themes of Examples 16-31, and optionally includes a control circuit configured to operate a pump to adjust the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's ocular pulse cycles over multiple ocular pulse cycles, thereby changing the amplitude or other characteristics of a vascular spontaneous pulse, venous induced pulse, or other ocular or other physiological characteristic over multiple ocular pulse cycles.
[0216] Example 33 may encompass or optionally combine with the themes of Examples 16-32, and optionally includes a control circuit configured to actuate a pump to adjust the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's intracranial pressure cycles over multiple intracranial pressure cycles, thereby changing the amplitude or other characteristics of a vascular spontaneous pulse, a venous induced pulse, or other ocular or other physiological characteristic over multiple intracranial pressure cycles.
[0217] Example 34 may encompass the themes of Examples 16 to 33, or may optionally combine them, and optionally, the visualization support device includes, or is coupled to, an image processor circuit for analyzing the first visualization and one or more subsequent visualizations in order to identify an index of internal pressure based on a change in at least one ocular characteristic or other physiological characteristic between the first visualization and the subsequent visualization.
[0218] Example 35 may encompass or employ a subject, such as a method, which may include receiving data directly or indirectly indicating at least one of intracranial pressure (ICP), intraocular pressure (IOP), or the relationship between ICP and IOP, and controlling a pump based on the received data as a feedback control variable to adjust the fluid pressure within a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, wherein the control includes using further monitoring of the received data to control the pump.
[0219] Example 36 may encompass the subject matter of Example 1, or may optionally combine it with that subject matter, and optionally includes receiving data that directly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, using at least one of the following indicators: IOP detected by a fluid pressure sensor pre-implanted in the intraocular cavity of the eye, ICP detected by a fluid pressure sensor pre-implanted in fluid communication with the cerebrospinal region, or intraorbital pressure detected by a sensor pre-implanted in fluid communication with the cerebrospinal region.
[0220] Example 37 may encompass or optionally combine with the subject matter of Example 35 or 36, and optionally, receiving data includes receiving data that indirectly indicates at least one of the following: intraorbital pressure, ICP, IOP, or the relationship between ICP and IOP, wherein the data to be received includes at least one of the following indicators: ocular vascular characteristics, intermembrane pressure difference including the cupping / papillary diameter relationship, systemic blood pressure, body parameters including body mass index (BMI), hydrostatic pressure difference corresponding to various different body positions or postures, spontaneous or induced venous pulsation, cribriform or position of the cribriform plate, episcleral venous pressure, or orbital pressure.
[0221] Example 38 may encompass the themes of Examples 35-37, or may be optionally combined with them, and optionally includes the use of a visualization support device for visualizing a portion of the eye at various different fluid pressures within a housing in order to monitor ICP indicators.
[0222] Example 39 may encompass the themes of Examples 35-38, or may be optionally combined with them, and optionally includes the use of a visualization support device for obtaining an index of the indentation / nipple diameter ratio.
[0223] Example 40 may encompass the themes of Examples 35 to 39, or may be optionally combined with those themes, and optionally includes using a fundus camera as a visualization support device.
[0224] Example 41 may encompass the themes of Examples 35-40, or may be optionally combined with them, and optionally includes using an optical coherence tomography (OCT) system as a visualization support device.
[0225] Example 42 may encompass the themes of Examples 35 to 41, or may be optionally combined with them, and optionally includes using blood pressure data indicators as at least part of the above data.
[0226] Example 43 may encompass the themes of Examples 35 to 42, or may be optionally combined with them, and may optionally include using at least one of the indices of spontaneous venous pulse data or evoked venous pulse data as at least part of the above data.
[0227] Example 44 may encompass the themes of Examples 35 to 43, or may be optionally combined with them, and optionally includes providing at least a portion of the above data by detecting a change in at least one of the following: vascular dimensions, flow characteristics, pulsation, oxygenation, or color characteristics.
[0228] Example 45 may encompass the themes of Examples 35 to 44, or may optionally combine them, and may optionally include using information about the patient's tilt or posture to provide at least a portion of the above data.
[0229] Example 46 may encompass or optionally combine with the themes of Examples 35-45, and optionally includes using a tonometer to provide at least some of the above data, wherein the tonometer is integrated or coupled to a housing so that the tonometer can access the eye.
[0230] Example 47 may encompass or optionally combine with the themes of Examples 35-46, and optionally includes using a contact lens to provide at least some of the above data, the contact lens having a strain sensor or other sensor incorporated to detect ocular characteristics.
[0231] Example 48 may encompass the themes of Examples 35 to 47, or may be optionally combined with them, and optionally includes using information relating to axonal transport to provide at least a portion of the above data.
[0232] Example 49 may encompass the themes of Examples 35 to 48, or may be optionally combined with them, and optionally includes using information regarding the position or shape of a sieve plate to provide at least some of the above data.
[0233] Example 50 may encompass or optionally combine with the themes of Examples 35 to 49, and optionally includes performing an initial visualization of a patient's eye at a first fluid pressure within a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, performing visualization with the goggle housing positioned above the patient's eye; performing one or more subsequent visualizations of the patient's eye at a subsequent fluid pressure within the goggle housing, performing visualization with the goggle housing positioned above the patient's eye at a subsequent fluid pressure different from the first fluid pressure; and using the initial and subsequent visualizations to identify a change in at least one eye characteristic corresponding to a change between the first fluid pressure and the subsequent fluid pressure within the housing.
[0234] Example 51 may encompass or employ a subject, such as a method, which may include: performing initial visualization of a patient's eye at a first fluid pressure in one or more cavities of a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, performing visualization with the goggle housing positioned above the patient's eye; performing subsequent visualization of the patient's eye at a subsequent fluid pressure in one or more cavities of the goggle housing, performing visualization with the goggle housing positioned above the patient's eye, at a subsequent fluid pressure different from the first fluid pressure; and using the initial and subsequent visualizations, identifying a change in at least one eye characteristic or other physiological characteristic corresponding to the change between the first fluid pressure and the subsequent fluid pressure within the housing.
[0235] Example 52 may encompass the subject matter of Example 51, or may optionally combine it with that subject matter, and optionally includes visualization including performing optical coherence tomography (OCT).
[0236] Example 53 may encompass or optionally combine with the subject matter of Example 51 or 52, and optionally includes the visualization including the use of a fundus camera.
[0237] Example 54 may encompass the themes of Examples 51 to 53, or may optionally combine them, and optionally, visualization may include performing ultrasound imaging.
[0238] Example 55 may encompass or optionally combine with the themes of Examples 51-54, and optionally includes analyzing the initial and subsequent visualizations to identify a change in at least one ocular or other physiological characteristic between the initial and subsequent visualizations.
[0239] Example 56 may encompass or optionally combine with the themes of Examples 51-55, and optionally, the analysis may include comparing pixels or voxels associated with images of blood vessels between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing to identify changes in blood flow velocity.
[0240] Example 57 may encompass or optionally combine with the themes of Examples 51-56, and optionally, the analysis may include comparing pixels or voxels associated with images of blood vessels to identify changes in blood vessel-related color characteristics between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing.
[0241] Example 58 may encompass the themes of Examples 51-57, or may be optionally combined with them, and optionally includes determining whether the analysis indicates that changes in ocular characteristics or other physiological characteristics between the initial visualization and the subsequent visualization meet a defined vascular diameter change criterion or other defined criterion.
[0242] Example 59 may encompass or optionally combine with the themes of Examples 51-58, and optionally, the analysis may include identifying an index of internal pressure based on changes in ocular or other physiological characteristics between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing.
[0243] Example 60 may encompass the themes of Examples 51-59, or may be optionally combined with them, and optionally includes analyzing the correlation of intracranial pressure (ICP) to an index of internal pressure based on changes in ocular or other physiological characteristics between initial and subsequent visualizations at different applied pressures within one or more cavities of the housing.
[0244] Example 61 may encompass or optionally combine with the themes of Examples 51-60, and optionally, the analysis may include using the initial and subsequent visualizations to identify a change in at least one ocular or other physiological characteristic between the initial and subsequent visualizations, wherein the at least one ocular or other physiological characteristic includes at least one of the amplitude, vascular diameter, location, or other characteristics of spontaneous or venous pulsation.
[0245] Example 62 may encompass or optionally combine with the themes of Examples 51 to 61, and optionally includes adjusting the fluid pressure in one or more cavities of the goggle housing to correspond to one or more parts of the patient's cardiac cycle.
[0246] Example 63 may encompass or optionally combine with the themes of Examples 51-62, and optionally includes adjusting the fluid pressure within the cavity of the goggle housing to correspond to one or more portions of the patient's ocular pulse wave period.
[0247] Example 64 may encompass or optionally combine with the themes of Examples 51-63, and optionally includes adjusting the fluid pressure in one or more cavities of the goggle housing to correspond to one or more portions of the patient's cardiac cycle over multiple cardiac cycles, in order to maximize the amplitude or other characteristics of at least one of vascular spontaneous pulses, venous induced pulses, or other ocular or other physiological characteristics over multiple cardiac cycles.
[0248] Example 65 may encompass or optionally combine with the themes of Examples 51-64, and optionally includes analyzing the initial and subsequent visualizations to identify an index of intracellular pressure based on a change in at least one ocular or other physiological characteristic between the initial and subsequent visualizations.
[0249] Example 66 may encompass or employ a subject, such as a method, which may include releasing gauge pressure from a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, performing visualization of the patient's eye with atmospheric fluid pressure within the goggle housing, performing visualization with the goggle housing positioned above the patient's eye to detect eye characteristics that have achieved an eye characteristic recovery criterion, and applying gauge pressure to the goggle housing to achieve an eye characteristic change criterion.
[0250] Example 67 may encompass the subject matter of Example 66, or may optionally combine it with that subject matter, and optionally includes releasing the gauge pressure by opening a controllable vent that is in fluid communication with the goggle housing.
[0251] Example 68 may encompass or optionally combine with the subject matter of Example 66 or 67, and optionally includes performing an initial visualization of the patient's eye with gauge pressure in a goggle housing sized and shaped to be positioned above the patient's eye without contact with the patient's eye, the initial visualization being performed immediately before releasing the gauge pressure from the goggle housing positioned above the patient's eye; performing one or more subsequent visualizations of the patient's eye, the one or more subsequent visualizations being performed after releasing the gauge pressure from the goggle housing positioned above the patient's eye; and using the initial and subsequent visualizations to confirm the realization of an eye characteristic recovery criterion in at least one eye characteristic corresponding to the release of the gauge pressure from the goggle housing.
[0252] The above description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the present invention can be carried out. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also intend examples in which only the shown or described elements are provided. Furthermore, the inventors also intend examples using any combination or substitution of the shown or described elements (or one or more embodiments thereof) with respect to any particular example (or one or more embodiments thereof) or other example (or one or more embodiments thereof) shown or described herein.
[0253] In the event of any conflict in usage between this specification and any document incorporated herein by reference, the usage herein shall prevail. In this specification, the term “one” is used to include “one” or “two or more,” as is common in patent literature, and without regard to any other examples or uses such as “at least one” or “one or more.” In this specification, the term “or” is used in the sense of a non-exclusive OR, and therefore “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise specified. In this specification, the term “contains” is used as a synonym for the corresponding term “equipped with.” Furthermore, in the claims, the terms “contains” and “equipped with” are not limiting; that is, a system, apparatus, article, composition, formulation, or process that includes elements other than those enumerated after such terms in a given claim is also considered to be within the scope of that claim. Furthermore, in the claims, terms such as “first,” “second,” and “third” are used merely as labels and do not impose numerical requirements on the subject matter.
[0254] Geometric terms such as "parallel," "perpendicular," "circular," or "square" do not require absolute mathematical rigor unless otherwise specified in the context. Rather, such geometric terms allow for manufacturing variations or functionally equivalents. For example, if an element is described as "circular" or "approximately circular," this description includes components that are not strictly circular (e.g., slightly elliptical or polygonal).
[0255] Examples of the methods described herein can be implemented, at least in part, by a machine or computer. Some examples include computer-readable or machine-readable media coded with instructions that function to configure and set up electronic devices to perform methods such as those described in the above embodiments. Implementations of such methods may include code such as microcode, assembly language code, or high-level language code. Such code may include computer-readable instructions for performing various methods. The code may form several parts of a computer program product. Furthermore, in one example, the code may be tangibly stored in one or more volatile, non-temporary, or non-volatile tangible computer-readable media during execution or at other times. Examples of these tangible computer-readable media include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact discs and digital video discs), magnetic cassettes, memory cards or memory sticks, random access memory (RAM), and read-only memory (ROM).
[0256] The above description is illustrative and not limiting. For example, the above embodiments (or one or more of them) may be used in each other or in combination with each other. Those skilled in the art may use other embodiments by examining the above description. The abstract is provided to enable readers to quickly grasp the essence of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the claims or their meaning. In addition, in the above detailed description, various features may be grouped together for the purpose of streamlining the disclosure. This should not be interpreted as meaning that any disclosed feature not described in the claims is essential to any claim. Rather, the subject matter of the invention may be fewer features than all the features of one specific embodiment disclosed. Thus, the claims are incorporated into the detailed description herein as examples or embodiments, and each claim stands independently as an individual embodiment. Such embodiments are thought to be able to be combined with each other in various combinations or permutations. The scope of the invention should be determined by referring to the appended claims, along with the entire scope of equivalents for which such claims are granted.
Claims
1. A device used for diagnosing or treating ocular symptoms in a patient's eye, A housing configured to be placed above a patient's eye to form a cavity and to form a cavity environment above the eye, wherein the cavity environment includes a cavity pressure that can change over time, The apparatus comprises an imaging system positioned in close proximity to the housing and configured to detect an indicator of spontaneous venous pulsation (hereinafter referred to as SVP) in the patient's eye.
2. The system further comprises a control circuit capable of communicating with the aforementioned imaging system, and the control circuit is The SVP indicator detected by the imaging system is monitored, The apparatus according to claim 1, further configured to control a pressure source that can communicate with the housing to adjust the cavity pressure within the housing based on a monitored SVP index.
3. The apparatus according to claim 2, wherein the control circuit is configured to control the pressure source to minimize the monitored SVP index by adjusting the cavity pressure within the housing based on the monitored SVP index detected by the imaging system.
4. The apparatus according to claim 1, wherein the imaging system includes at least one of a magnetic resonance imaging (MRI) system, an ultrasound system, an optical coherence tomography (OCT) system, a camera system, or an X-ray system.
5. The apparatus according to claim 4, wherein the camera system includes at least one of a fundus camera, a video camera, or a smartphone camera.
6. The apparatus according to claim 1, further comprising a pressure detection detector.
7. The apparatus according to claim 6, wherein the pressure detection detector includes at least one of a pressure sensor that communicates with the cavity, a pressure sensor implanted in the intraocular space of the patient's eye, a tonometer, or a direct ICP sensor system.
8. The pressure detection detector device is the tonometer. The apparatus according to claim 7, wherein the housing further includes a sealable port disposed on the surface of the housing, the sealable port being configured to form a seal between the housing and the pressure sensing device when the pressure sensing device is at least partially inserted into the cavity through the sealable port and positioned in close proximity to the patient's eye.
9. The apparatus according to claim 8, wherein the sealable port includes a seal interface configured to form a gas-impermeable seal between the housing and the pressure sensing device when the pressure sensing device is inserted into the cavity through the sealable port.
10. The apparatus according to claim 9, wherein the sealing interface includes at least one of an O-ring, a sleeve, or a bellows.
11. The apparatus according to claim 1, further comprising a motion detection detector device.
12. The apparatus according to claim 11, wherein the motion detection detector device includes at least one of an inclinometer, an accelerometer, a multi-axis inclinometer, or a multi-axis accelerometer.
13. The apparatus according to claim 1, further comprising a controllable vent disposed on the surface of the housing and in fluid communication with the cavity.
14. The apparatus according to claim 13, wherein the controllable vent is configured to equalize the pressure of the cavity environment with the surrounding environment of the cavity when in operation.
15. The apparatus according to claim 13, wherein the controllable vent is configured to reduce the humidity level of the cavity environment when in operation.