Ophthalmic treatment device and method using independent pressure source - Patents.com
By independently controlling the environment of the left and right eye and using different treatment pressure regimens to deal with binocular diseases in each eye, the problem of difficulty in dealing with abnormal intraocular pressure in the prior art is solved, and personalized treatment and better treatment effects are achieved for each eye.
Patent Information
- Application Number
- JP2023190769
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-06-28
- Filing Date
- 2023-11-08
- Publication Date
- 2025-04-07
- Estimated Expiration
- 2039-06-27
AI Technical Summary
The prior art is difficult to effectively deal with abnormal ocular pressure caused by binocular diseases such as glaucoma or optic cephaloem, and treatment plans are difficult to personalize for different progress rates of each eye.
A system and method are designed to treat each eye by independently controlling the environment of the left and right eye, employing different treatment pressure regimens, including using left and right covers to define the cavity of each eye, and adjusting the cavity pressure of each eye separately through the left and right pressure sources.
Personalized treatment for each eye can be achieved, and binocular diseases can be effectively managed and the treatment effect and quality of patients can be improved.
Smart Images

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Abstract
Description
[Background technology]
[0001] Binocular diseases, such as binocular diseases associated with glaucoma or optic disc edema, can insidiously rob a patient of their vision without proper care. Measurement of asymmetric intraocular pressure (IOP) levels in a patient, such as when different IOP levels can be detected in the patient's left and right eyes, can indicate the presence of ocular disease and the need for different treatment regimens, such as a different treatment regime for each of the patient's left and right eyes. Because the progression of binocular diseases can affect the patient's left and right eyes at different rates, a device that can apply separate treatment protocols, such as a different treatment protocol for each of the left and right eyes, can greatly improve patient outcomes.
[0002] Dupps (US Pat. No. 5,393,633) refers to a system for characterizing biomechanical properties of tissue that includes an imaging system and a perturbation element that includes a transparent chamber and a pump.
[0003] Kang (US Pat. No. 5,399,633) describes a miniature nebulizer for eye treatment that includes a goggle unit having an air hole and at least one air chamber that communicates with the air hole and fits over the user's eye. A number of exhaust holes are provided in the goggle unit to exhaust air.
[0004] Skiba's U.S. Patent No. 5,333,636 describes a mask that is worn around the eyes and includes one or more mist outlets and an atomizer that atomizes medication so that the mist exits the mist outlets to deliver the medication to one or both eyes.
[0005] Guillon (U.S. Patent No. 5,333,633) describes an eye cover adapted to provide a sealed area around a user's eyes, a means for holding the eye cover in place, and a means for supplying dry air to the eye cover. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] U.S. Patent No. 7,935,058 [Patent Document 2] U.S. Patent No. 5,807,357 [Patent Document 3] US Patent Application Publication No. 2002 / 0124843 [Patent Document 4] US Patent Application Publication No. 2007 / 0265505 Summary of the Invention
[0007] Eye diseases such as glaucoma and optic disc edema affect over 60 million people (ages 40-80) worldwide, with the number of patients estimated to increase to 110 million by 2040. Although eye diseases are often bilateral (e.g., affecting both eyes of a patient), glaucoma and optic disc edema often do not affect both eyes equally or at the same rate of progression. In fact, treating eye diseases with two different treatment regimens, such as a left treatment regimen for the left eye and a right treatment regimen for the right eye, allows caregivers to customize treatment procedures to a patient's unique disease, such as significantly improving patient outcomes.
[0008] The inventors have recognized, inter alia, that there is a need in the art for systems and methods that can apply treatment regimens to an eye, such as applying a left treatment regimen to a left eye and a right treatment regimen to a right eye, or simultaneously applying a left treatment regimen to a left eye and a right treatment regimen to a right eye, to treat, inhibit or prevent an ocular disease. The devices and methods described herein can control, such as establish, regulate and maintain, an ocular environment on a patient's eye, such as at least one of a left ocular environment on a patient's left eye or a right ocular environment on a patient's right eye. In one example, control of the left ocular environment can be independent of the right ocular environment, and control of the right ocular environment can be independent of the left ocular environment. In one example, the ocular environment can include a working fluid, where the working fluid can include a working fluid property, such as at least one of a working fluid pressure or a working fluid composition.
[0009] Independent control of the left ocular environment and the right ocular environment, as applied to the patient's left eye and the patient's right eye, respectively, allows treatment regimens to be tailored to each individual patient's ocular disease, such as improving disease management, which can improve patient outcomes. This specification describes, among other things, devices and methods of control, such as simultaneous independent control of the left ocular environment on a patient's left eye and the right ocular environment on a patient's right eye, to treat, inhibit or prevent ocular disease.
[0010] The device can include a left cover sized and shaped to fit over a left eye to define a left cavity between the left cover and the front of the patient's left eye, and a right cover sized and shaped to fit over a right eye to define a right cavity between the right cover and the front of the patient's right eye. The device can include a left pressure source for applying a left working fluid to the left cavity, such as a left pressure source configured to adjust fluid pressure in the left cavity. The left pressure source can generate a left cavity pressure, such as a left cavity gauge pressure including a positive left cavity gauge pressure and a negative left cavity gauge pressure. The device can include a right pressure source for applying a right working fluid to the right cavity, such as a right pressure source configured to adjust fluid pressure in the right cavity. The right pressure source can generate a right cavity pressure, such as a right cavity gauge pressure including a positive right cavity gauge pressure and a negative right cavity gauge pressure. The right pressure source can be separate from the left pressure source, e.g., the left pressure source can be configured to generate a left cavity pressure independent of the right pressure source and the right pressure source can be configured to generate a right cavity pressure independent of the left pressure source. In generating a left cavity pressure in the left cavity with the left pressure source and a right cavity pressure in the right cavity with the right pressure source, the device can apply different gauge pressures to each of the left and right eyes independently, such as to improve treatment of ocular disease by tailoring treatment pressure regimens to each of the left and right eyes.
[0011] A summary of several non-limiting aspects of the present subject matter follows. Aspect 1 may include or use subject matter (such as an apparatus, system, device, method, means for performing a plurality of operations, or a device-readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), such as an apparatus for applying a treatment regimen to an eye, such as applying a left treatment regimen to a left eye and a right treatment regimen to a right eye, or simultaneously applying a left treatment regimen to a left eye and a right treatment regimen to a right eye, to treat, inhibit, or prevent an ocular disease. A left cover sized and shaped to fit over a patient's left eye can define a left cavity between the left cover and an anterior surface of the left eye. A left pressure source in communication with the left cavity can be configured to adjust fluid pressure in the left cavity. A right cover sized and shaped to fit over a patient's right eye can define a right cavity between the right cover and an anterior surface of the right eye. A right pressure source in communication with the right cavity can be configured to adjust fluid pressure in the right cavity. A control circuit coupled to at least one of the left pressure source or the right pressure source can be configured such that the left pressure source can regulate the fluid pressure in the left cavity independent of the right pressure source and the right pressure source can regulate the fluid pressure in the right cavity independent of the left pressure source.
[0012] Aspect 2 may include or use, or may optionally be combined with the subject matter of aspect 1 for optional inclusion or use, a left cavity sensor in communication with the left cavity for detecting an indicator of a left eye environment in the left cavity, a right cavity sensor in communication with the right cavity for detecting an indicator of a right eye environment in the right cavity, and a redundant sensor configured to detect at least one of an indicator of the left eye environment, an indicator of the right eye environment, or an indicator of a relationship between the indicator of the left eye environment and the indicator of the right eye environment.
[0013] Aspect 3 may include or use an apparatus, or may optionally be combined for optional inclusion or use with the subject matter of one or any combination of aspects 1 or 2, wherein the left cavity sensor includes a left pressure sensor detecting an indication of left pressure in the left cavity, the right cavity sensor includes a right pressure sensor detecting an indication of right pressure in the right cavity, and the redundant sensor includes a redundant sensor detecting an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment.
[0014] Aspect 4 may include or use an apparatus, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 1-3, where the redundant sensor includes a differential pressure sensor configured to detect a difference between an indication of left pressure in the left cavity by a left differential pressure sensor and an indication of right pressure in the right cavity by a right differential pressure sensor.
[0015] Embodiment 5 may include or use a redundant sensor including a differential signal sensor configured to sense a difference between an indication of left pressure from the left cavity sensor by the left differential signal sensor and an indication of right pressure from the right cavity sensor by the right differential signal sensor, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 1-4.
[0016] Aspect 6 may include or use, or may optionally be combined with the subject matter of one or any combination of Aspects 1-5 for optionally including or using, a system control circuit configured to receive and process at least one of an indication of the left eye environment in the left cavity, an indication of the right eye environment in the right cavity, or an indication of the relationship between the left eye environment and the right eye environment.
[0017] Aspect 7 may include or use a control circuit including a left control circuit coupled to a left pressure source and capable of receiving and processing at least one of an indication of a left ocular environment or an indication of a relationship between the left ocular environment and a right ocular environment, and a right control circuit in communication with a right pressure source and capable of receiving and processing at least one of an indication of a right ocular environment or an indication of a relationship between the left ocular environment and a right ocular environment, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of Aspects 1-6.
[0018] Embodiment 8 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 1-7, a left control circuit including a left control circuit configured to adjust a left pressure source to generate a non-atmospheric pressure in the left cavity toward a left target cavity pressure in the left cavity, and a right control circuit including a right control circuit configured to adjust a right pressure source to generate a non-atmospheric pressure in the right cavity toward a right target cavity pressure in the right cavity.
[0019] Aspect 9 may include or use, or may be optionally combined with the subject matter of one or any combination of aspects 1-8 for optionally including or using, a left biosensor in communication with a left control circuit and configured to sense at least one of an indication of left intraocular pressure (IOP) in a left eye or an indication of cerebrospinal fluid pressure (CSFP) in the patient, and a right biosensor in communication with a right control circuit and configured to sense at least one of an indication of right IOP in a right eye or an indication of CSFP in the patient.
[0020] Embodiment 10 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 1-9, including a left control circuit including a left control circuit configured to receive an indication of left IOP and adjust a left pressure source to generate a non-atmospheric pressure toward a left target IOP level [G] based on the received indication of left IOP, and a right control circuit including a right control circuit configured to receive an indication of right IOP and adjust a right pressure source to generate a non-atmospheric pressure toward a right target IOP level based on the received indication of right IOP.
[0021] Aspect 11 may include or use, or may be optionally combined with the subject matter of one or any combination of Aspects 1-10 for optional inclusion or use, a left control circuit that may be configured to generate a non-atmospheric pressure toward a left target IOP level, the left control circuit including a left target IOP level in the left eye in a range of about 10 mmHg to about 21 mmHg, and a right control circuit that may be configured to generate a non-atmospheric pressure toward a right target IOP level, the right control circuit including a right target IOP level in the right eye in a range of about 10 mmHg to about 21 mmHg.
[0022] Aspect 12 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of aspects 1-11, including a left control circuit configured to adjust a left pressure source to generate a non-atmospheric pressure in the left cavity to equalize an index of a left translaminar pressure gradient (TLPG) associated with the left eye, where equalizing the index of the left TLPG includes lowering the index of the left TLPG from a first left TLPG level to a lower second left TLPG level, and a right control circuit configured to adjust a right pressure source to generate a non-atmospheric pressure in the right cavity to equalize an index of a right TLPG associated with the right eye, where equalizing the index of the right TLPG includes lowering the index of the right TLPG from a first right TLPG level to a lower second right TLPG level.
[0023] Embodiment 13 may include or utilize, or may be optionally combined for optionally including or use with the subject matter of one or any combination of embodiments 1-12, a left control circuit including a left control circuit configured to adjust a left pressure source to generate a non-atmospheric pressure in the left cavity to improve the indicator of axonal transport in the left optic nerve of the left eye, and a right control circuit including a right control circuit configured to adjust a right pressure source to generate a non-atmospheric pressure in the right cavity to improve the indicator of axonal transport in the right optic nerve of the right eye, wherein improving the indicator of axonal transport includes increasing a rate of axonal transport from a first axonal transport level to a second higher axonal transport level.
[0024] Aspect 14 may include or use, or may be optionally combined for optionally including or using, the subject matter of one or any combination of Aspects 1-13, a left control circuit including a left control circuit configured to adjust a left pressure source to generate a non-atmospheric pressure in the left cavity to treat, inhibit or prevent ocular disease in the left eye, and a right control circuit including a right control circuit configured to adjust a right pressure source to generate a non-atmospheric pressure in the right cavity to treat, inhibit or prevent ocular disease in the right eye.
[0025] Aspect 15 can include or use, or can be optionally combined with the subject matter of one or any combination of Aspects 1-14 to optionally include or use, a left passive cavity check valve in communication with the left cavity and configured to limit left pressure in the left cavity to a left cracking pressure, and a right passive cavity check valve in communication with the right cavity and configured to limit right pressure in the right cavity to a right cracking pressure.
[0026] Aspect 16 may include or use subject matter (such as an apparatus, system, device, method, means for performing an action, or a device-readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), or may be optionally combined with the subject matter of one or any combination of aspects 1-15 to optionally include or use a method of using the apparatus. The apparatus may include a left cover sized and shaped to fit over a left eye to define a left cavity between the left cover and the front of the patient's left eye, a left pressure source in communication with the left cavity and configured to adjust fluid pressure in the left cavity, a right cover sized and shaped to fit over a right eye to define a right cavity between the right cover and the front of the patient's right eye, and a right pressure source in communication with the right cavity and configured to adjust fluid pressure in the right cavity, the left pressure source configured to adjust fluid pressure in the left cavity independently of the right pressure source, and the right pressure source configured to adjust fluid pressure in the right cavity independently of the left pressure source. The method can include receiving, by the device, at least one of an indication of a left ocular environment, an indication of a right ocular environment, an indication of a left intraocular pressure (IOP) in the left eye, an indication of a right IOP in the right eye, or an indication of a cerebrospinal fluid pressure (CSFP) in the patient. The method can include adjusting at least one of a left pressure source to generate a non-atmospheric pressure in the left cavity based on at least one of the received indications, or a right pressure source to generate a non-atmospheric pressure in the right cavity based on at least one of the received indications.
[0027] Aspect 17 may include or use a method, or may optionally be combined for optionally including or use with the subject matter of one or any combination of Aspects 1-16, where the step of receiving an indication includes receiving an indication of a left ocular environment including an indication of left cavity pressure, the step of adjusting the pressure source includes adjusting the left pressure source based on the indication of the left cavity pressure, the step of receiving an indication includes receiving an indication of a right ocular environment including an indication of right cavity pressure, and the step of adjusting the pressure source includes adjusting the right pressure source based on the indication of the right cavity pressure.
[0028] Aspect 18 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Aspects 1-17, where the step of receiving an indication includes receiving an indication of left IOP, the step of adjusting the pressure source includes adjusting the left pressure source based on the indication of left IOP, the step of receiving an indication includes receiving an indication of right IOP, and the step of adjusting the pressure source includes adjusting the right pressure source based on the indication of right IOP.
[0029] Aspect 19 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Aspects 1-18, where the step of receiving an indication includes receiving an indication of left cavity pressure and left IOP, the step of adjusting the pressure source includes adjusting the left pressure source based on the indication of the left cavity pressure and left IOP, the step of receiving an indication includes receiving an indication of right cavity pressure and right IOP, and the step of adjusting the pressure source includes adjusting the right pressure source based on the indication of the right cavity pressure and right IOP.
[0030] Aspect 20 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 1-18, where the step of receiving an indication includes receiving an indication of a left translaminar pressure difference (TPD) associated with a left eye, the step of adjusting the pressure source includes adjusting a left pressure source to equalize the indication of the left TPD, the step of receiving an indication includes receiving an indication of a right TPD associated with a right eye, the step of adjusting the pressure source includes adjusting a right pressure source to equalize the indication of the right TPD, and equalizing the indication of the TPD includes reducing the indication of the TPD from a first TPD level to a lower second TPD level.
[0031] Aspect 21 may include or use subject matter (such as an apparatus, system, device, method, means for performing a plurality of operations, or a device-readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), such as an apparatus for adjusting fluid pressure applied to at least one of a left cavity located over a left eye of a patient or a right cavity located over a right eye of a patient to treat, inhibit, or prevent an ocular disease. The apparatus may include a differential sensor in communication with the left and right cavities configured to sense at least one of an indication of a left ocular environment in the left cavity, an indication of a right ocular environment in the right cavity, or an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment. The apparatus may include a control circuit in communication with the system sensor configured to receive and process at least one of an indication of a left ocular environment in the left cavity, an indication of a right ocular environment in the right cavity, or an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment.
[0032] Aspect 22 may include or use at least one of a left cavity sensor coupled to a system control circuit for detecting an indicator of a left eye environment in the left cavity, or a right cavity sensor coupled to a system control circuit for detecting an indicator of a right eye environment in the right cavity, or may be optionally combined with the subject matter of aspect 21 for optional inclusion or use.
[0033] Aspect 23 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of aspects 21 or 22, including a differential sensor including a differential pressure sensor configured to detect a difference between an indication of left pressure in the left cavity sensed by a left differential pressure sensor and an indication of right pressure in the right cavity sensed by a right differential pressure sensor.
[0034] Example 24 may include or use, or may optionally be combined for optionally including or using, the subject matter of one or any combination of Examples 21-23, including a differential sensor including a differential signal sensor configured to detect a difference between an indication of left pressure from a left pressure sensor detected by a left differential signal sensor and an indication of right pressure from a right pressure sensor detected by a right differential signal sensor.
[0035] Embodiment 25 can include or use, or can optionally be combined with the subject matter of one or any combination of embodiments 21-24 for optionally including or using, a pressure source in communication with at least one of the left cavity or the right cavity and configured to apply a non-atmospheric pressure to at least one of the left cavity or the right cavity.
[0036] Embodiment 26 can include or use a pressure source including a pressure source configured to apply non-atmospheric pressure to the left and right cavities, or can be optionally combined for optionally including or using the subject matter of one or any combination of embodiments 21-25.
[0037] Embodiment 27 may include or use, or may be optionally combined with the subject matter of one or any combination of embodiments 21-26 to optionally include or use, a left cavity valve in communication with the left cavity and configured to adjust an index of left pressure in the left cavity, and a right cavity valve in communication with the right cavity and configured to adjust an index of right pressure in the right cavity.
[0038] Embodiment 28 may include or use a left valve including at least one of a passive left valve or an active left valve, and a right valve including at least one of a passive right valve or an active right valve, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 21-27.
[0039] Embodiment 29 may include or use, or may optionally be combined with the subject matter of one or any combination of embodiments 21-28 for optionally including or using, a left cavity valve including an active left cavity valve configured to adjust an indication of a left pressure based on at least one of the indications received by the system control circuit, and a right cavity valve including an active right cavity valve configured to adjust an indication of a right pressure based on at least one of the indications received by the system control circuit.
[0040] Aspect 30 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of aspects 21-29, a left biosensor in communication with the system control circuitry configured to detect at least one of an indication of left intraocular pressure (IOP) in a left eye or an indication of cerebrospinal fluid pressure (CSFP) in a patient, and a right biosensor in communication with the system control circuitry configured to detect at least one of an indication of right IOP in a right eye or an indication of CSFP in a patient, wherein the left cavity valve includes an active left cavity valve configured to adjust the indication of left pressure based on at least one of the indications received from the left biosensor, and the right cavity valve includes an active right cavity valve configured to adjust the indication of right pressure based on at least one of the indications received from the right biosensor.
[0041] Embodiment 31 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 21-30, including a system control circuit including a left control circuit configured to receive an indication of left IOP and adjust a left pressure in the left cavity via an active left valve toward a left target IOP level based on the received indication of left IOP, and a right control circuit configured to receive an indication of right IOP and adjust a right pressure in the right cavity via an active right valve toward a right target IOP level based on the received indication of right IOP.
[0042] Embodiment 32 may include or use, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of embodiments 21-31, a left control circuit configured to adjust a left pressure in the left cavity by a left active valve to equalize an index of a left transcriboid plate pressure difference (TPD) associated with a left eye, where equalizing the index of the left TPD includes lowering the index of the left TPD from a first left TPD level to a lower second left TPD level, and a right control circuit configured to adjust a right pressure in the right cavity by a right active valve to equalize an index of a right TPD associated with a right eye, where equalizing the index of the right TPD includes lowering the index of the right TPD from a first right TPD level to a lower second right TPD level.
[0043] Embodiment 33 may include or utilize, or may be optionally combined with the subject matter of one or any combination of embodiments 21-32 for optionally including or using, a left control circuit configured to adjust a left pressure in the left cavity by a left active valve sufficient to improve the indicator of axonal transport in the left optic nerve of the left eye, and a right control circuit configured to adjust a right pressure in the right cavity by an active right valve sufficient to improve the indicator of axonal transport in the right optic nerve of the right eye, wherein improving the indicator of axonal transport includes increasing a rate of axonal transport from a first axonal transport level to a second higher axonal transport level.
[0044] Example 34 may include or use, or may be optionally combined for optionally including or using, the subject matter of one or any combination of Examples 21-33, including a left control circuit configured to adjust a left pressure in the left cavity via an active left valve to treat, inhibit or prevent ocular disease in the left eye, and a right control circuit configured to adjust a right pressure in the right cavity via an active right valve to treat, inhibit or prevent ocular disease in the right eye.
[0045] Embodiment 35 may include or use, or may be optionally combined with the subject matter of one or any combination of embodiments 21-34 to optionally include or use, a passive left valve in communication with the left cavity and configured to limit left pressure in the left cavity to a left cracking pressure, and a passive right valve in communication with the right cavity and configured to limit right pressure in the right cavity to a right cracking pressure.
[0046] Aspect 36 may include or use subject matter (such as an apparatus, a system, a device, a method, a means for performing a plurality of operations, or a device-readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), or may be optionally combined with subject matter of one or any combination of aspects 21-35 to optionally include or use a method of using an apparatus. The apparatus may include a system sensor including a left pressure sensor in communication with the left cavity for sensing an indication of a left pressure in the left cavity, a right pressure sensor in communication with the right cavity for sensing an indication of a right pressure in the right cavity, and a redundant sensor, a system control circuit in communication with the system sensor and configured to receive and process at least one of the indication of the left pressure or the indication of the right pressure, an active left valve in communication with the left cavity and in communication with the system control circuit, and an active right valve in communication with the right cavity and in communication with the system control circuit. The method may include sensing, by the system sensor, an indication of the left pressure in the left cavity and an indication of the right pressure in the right cavity. The method may include adjusting at least one of an active left valve based on an indication of the sensed left pressure, or an active right valve based on an indication of the sensed right pressure.
[0047] Aspect 37 may include or use, or may be optionally combined with the subject matter of one or any combination of Aspects 21-36 for optionally including or using, a left biosensor in communication with the system control circuitry configured to detect at least one of an indication of left intraocular pressure (IOP) in a left eye or an indication of cerebrospinal fluid pressure (CSFP) in the patient, and a right biosensor in communication with the system control circuitry configured to detect at least one of an indication of right IOP in a right eye or an indication of CSFP in the patient, wherein the step of adjusting at least one of the active left valve or the active right valve includes adjusting at least one of the active left valve based on at least one of the indications received from the left biosensor or the active right valve based on at least one of the indications received from the right biosensor.
[0048] Aspect 38 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Aspects 21-37, where the step of adjusting at least one of the active left valve or the active right valve includes adjusting at least one of the active left valve to change the left pressure toward a left target IOP level based on the received indication of left IOP, or the active right valve to change the right pressure toward a right target IOP level based on the received indication of right IOP.
[0049] Aspect 39 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 21-38, where the step of adjusting at least one of the active left valve or the active right valve includes adjusting at least one of the active left valve to equalize a measure of left transcriboid pressure difference (TPD) associated with the left eye, or the active right valve to equalize a measure of right TPD associated with the right eye, and where equalizing the measure of TPD includes reducing the measure of TPD from a first TPD level to a lower second TPD level.
[0050] Aspect 40 may include or use a method, or may optionally be combined for optionally including or use with the subject matter of one or any combination of Aspects 21-39, wherein the step of adjusting at least one of the active left valve or the active right valve comprises adjusting at least one of the active left valve to achieve a left pressure in the left cavity sufficient to improve the indicator of axonal transport in the left optic nerve of the left eye, or the active right valve to achieve a right pressure in the right cavity sufficient to improve the indicator of axonal transport in the right optic nerve of the right eye, wherein improving the indicator of axonal transport comprises increasing a rate of axonal transport from a first axonal transport level to a second higher axonal transport level.
[0051] Aspect 41 may include or use subject matter (such as an apparatus, system, device, method, means for performing a plurality of operations, or a device readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), such as an apparatus for limiting fluid pressure levels applied to a left and right eye of a patient. The apparatus may include a pressure source in communication with a left cavity located over the left eye and a right cavity located over the right eye, configured to adjust an indication of fluid pressure in the left and right cavities. The apparatus may include a differential sensor in communication with the left and right cavities, configured to sense at least one of an indication of a left ocular environment in the left cavity, an indication of a right ocular environment in the right cavity, or an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment.
[0052] Embodiment 42 may include or use, or may optionally be combined with the subject matter of embodiment 41 for optionally including or using, at least one of a left cavity sensor coupled to the left cavity for detecting an indication of the left ocular environment in the left cavity, or a right cavity sensor coupled to the right cavity for detecting an indication of the right ocular environment in the right cavity.
[0053] Aspect 43 may include or use an apparatus, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of aspects 41 or 42, wherein the differential sensor includes a differential pressure sensor configured to detect a difference between an indication of left pressure in the left cavity sensed by a left differential pressure sensor and an indication of right pressure in the right cavity sensed by a right differential pressure sensor.
[0054] Example 44 may include or use an apparatus, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Examples 41-43, wherein the differential sensor includes a differential signal sensor configured to detect a difference between an indication of left pressure from a left cavity sensor by a left differential signal sensor and an indication of right pressure from a right pressure sensor by a right differential signal sensor.
[0055] Embodiment 45 may include or use a system control circuit configured to communicate with a pressure source to receive and process at least one of an indication of a left ocular environment in the left cavity, an indication of a right ocular environment in the right cavity, or an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment, or may optionally be combined for optional inclusion or use with the subject matter of one or any combination of embodiments 41-44.
[0056] Aspect 46 may include or use an apparatus, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 41-45, where the indicator of the left ocular environment includes an indicator of left pressure in the left cavity, the indicator of the right ocular environment includes an indicator of right pressure in the right cavity, and the indicator of the relationship between the left ocular environment and the right ocular environment includes an indicator of a difference between the indicator of the left pressure and the indicator of the right pressure.
[0057] Example 47 may include or use a system control circuit including a pressure source circuit configured to adjust operation of the pressure source based on at least one of the received indicators, or may be optionally combined for optional inclusion or use with the subject matter of one or any combination of Examples 41-46.
[0058] Example 48 may include or use, or may optionally be combined for optionally including or using, the subject matter of one or any combination of Examples 41-47, a pressure source circuit including a pressure source logic circuit configured to generate a system fault based on at least one of the received indicators.
[0059] Embodiment 49 may include or use, or may optionally be combined for optional inclusion or use with the subject matter of one or any combination of embodiments 41-48, a pressure source circuit including a pressure source circuit configured to generate a system fault when at least one of an indication of left pressure exceeds a left pressure safety level or an indication of right pressure exceeds a right pressure safety level.
[0060] Embodiment 50 may include or use an apparatus, or may optionally be combined for optional inclusion or use with the subject matter of one or any combination of embodiments 41-49, wherein the indicator of the relationship between the left eye environment and the right eye environment includes an indicator of a difference between the left pressure indicator and the right pressure indicator, and the pressure source circuit includes a pressure source circuit configured to generate a system fault if the indicator of the difference exceeds a pressure difference safety level between the left pressure and the right pressure.
[0061] Embodiment 51 may include or use, or may be optionally combined with the subject matter of one or any combination of embodiments 41-50 to optionally include or use, a left valve in communication with the left cavity and configured to limit fluid pressure in the left cavity to a left pressure safety level, and a right valve in communication with the right cavity and configured to limit fluid pressure in the right cavity to a right pressure safety level.
[0062] Aspect 52 can include or use, or can optionally be combined with the subject matter of one or any combination of aspects 41-51 to optionally include or use, a left valve and a right valve, where at least one of the left pressure safety level or the right safety pressure level is in the range of about -50 mmHg to about 50 mmHg gauge.
[0063] Aspect 53 can include or use, or can optionally be combined with the subject matter of one or any combination of aspects 41-52 to optionally include or use, a left valve and a right valve, where at least one of the left pressure safety level or the right safety pressure level is in the range of about -35 mmHg to about 35 mmHg gauge.
[0064] Embodiment 54 can include or use a left valve and a right valve, where at least one of the left valve or the right valve includes a passive valve, or can be optionally combined with the subject matter of one or any combination of embodiments 41-53 to optionally include or use.
[0065] Embodiment 54 can include or use a left valve and a right valve, where at least one of the left valve or the right valve includes an active valve, or can be optionally combined with the subject matter of one or any combination of embodiments 41-53 to optionally include or use.
[0066] Aspect 56 may include or use subject matter (such as an apparatus, a system, a device, a method, a means for performing a plurality of operations, or a device-readable medium including a plurality of instructions that, when executed by a device, cause the device to perform a plurality of operations), or may be optionally combined with the subject matter of one or any combination of aspects 41-55 to optionally include or use a method of using the apparatus. The apparatus may include a pressure source in communication with a left cavity located over a left eye of a patient and a right cavity located over a right eye of a patient, and a system sensor including a left cavity sensor for detecting an indication of a left ocular environment in the left cavity, a right cavity sensor for detecting an indication of a right ocular environment in the right cavity, and a redundant sensor for detecting a relationship between the indication of the left ocular environment and the indication of the right ocular environment. The method may include detecting, by the system sensor, an indication of a left pressure in the left cavity and an indication of a right pressure in the right cavity. The method may include limiting pressure applied by the pressure source to the left and right cavities.
[0067] Aspect 57 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 41-56, including at least one of a left passive valve in communication with the left cavity or a right passive valve in communication with the right cavity, and the step of limiting the pressure includes selecting at least one of a left cracking pressure of the left passive valve or a right cracking pressure of the right passive valve.
[0068] Aspect 58 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Aspects 41-57, including at least one of a left active valve in communication with the left cavity and a right active valve in communication with the right cavity, and the step of limiting the pressure includes opening at least one of the left active valve or the right active valve based on at least one of an indication of the detected left pressure or an indication of the detected right pressure.
[0069] Example 59 may include or use a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of Examples 41-57, where opening at least one of the left active valve or the right active valve includes opening at least one of the left active valve or the right active valve based on a difference between an indication of a detected left pressure and an indication of a detected right pressure.
[0070] Aspect 60 may include or be used as a method, or may be optionally combined for optionally including or use with the subject matter of one or any combination of aspects 41-57, wherein the step of limiting pressure includes adjusting operation of the pressure source based on at least one of an indication of detected left pressure or an indication of detected right pressure.
[0071] This Summary is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive description of the invention. The Detailed Description is included to provide further information regarding the present patent application.
[0072] In the drawings, which are not necessarily drawn to scale, like numerals may describe like components in different figures. Like numerals with different letter suffixes may represent different instances of like components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present specification. [Brief description of the drawings]
[0073] [Figure 1] 1 illustrates an example of an apparatus for controlling the environment above a patient's eye, according to at least one example of the present disclosure. [Figure 1A] 1 illustrates an example of an apparatus including an example of a manual pressure source, according to at least one example of the present disclosure. [Figure 2A-2B]1 illustrates a side view of an example of a positive pressure cavity check valve in a closed position and an open position in accordance with at least one example of the present disclosure. [Figure 3A-3B] 1 illustrates a side view of an example of a negative pressure cavity check valve in a closed position and an open position in accordance with at least one example of the present disclosure. [Figure 4] 1 illustrates an example of a check valve assembly in accordance with at least one example of the present disclosure. [Figure 5A] 1 illustrates an example of a conduit, such as a first dual lumen conduit, in accordance with at least one example of the present disclosure. [Figure 5B] 1 illustrates an example of a conduit, such as a second dual lumen conduit, in accordance with at least one example of the present disclosure. [Figure 5C] 1 illustrates an example of a conduit, such as a third dual lumen conduit, in accordance with at least one example of the present disclosure. [Figure 6] 1 illustrates an example of an apparatus that can control a left ocular environment on a patient's left eye and a right ocular environment on a patient's right eye, in accordance with at least one example of the present disclosure. [Figure 7] 1 shows a schematic diagram of an example device that may include sensors, such as redundant sensors, in accordance with at least one example of the present disclosure. [Figure 8] 1 shows an example of a device that can independently control the left ocular environment on a patient's left eye and the right ocular environment on a patient's right eye with a single pressure source. [Figure 9] 1 shows a schematic diagram of an example device capable of controlling the ocular environment on a patient's eye by at least one of a main pressure source, a left pressure source, or a right pressure source. [Figure 10] 1 shows a schematic diagram of a second example device capable of controlling the ocular environment on a patient's eye by means of a one-way valve in communication with a main pressure source. [Figure 11] A schematic diagram of a third example device is shown that can control the ocular environment on a patient's eye by a one-way valve in communication with a main pressure source and at least one of the left cavity valve or the right cavity valve. [Figure 12] An example method is provided for using the device to receive an indication and adjust a pressure source based on the received indication. [Figure 13]An example method is provided for using the device to sense an indication and adjust a valve based on the sensed indication. [Figure 14] An example method is provided for using the device to sense the indicator and limit the pressure applied to the cavity. [Figure 15] 1 shows an example block diagram of an example computer that can be used as a control circuit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0074] 1 shows an example of such a device 100 for controlling the environment above a patient's eye. In one example, the patient's eye can include organs of the visual system, portions of the organs, such as the anterior surface of the patient's eye, and surrounding tissue. The device 100 can include a cover 110, a fluid regulator 120, a sensor 130, a control circuit 140, and a pressure source 150.
[0075] The cover 110 can be sized and shaped to surround and be spaced apart from the patient's eye, such as without contacting the eye, including the anterior surface of the patient's eye. The cover 110 can be sized and shaped to surround and cover both the patient's eyes, such as the patient's left and right eyes. In one example, the cover 110 can include a mask, such as the cover 110 similar in shape and function to a diving or snorkeling mask. The cover 110 can include a lens portion 182, such as to allow the patient to see outwardly through the cover 110, or to allow viewing of the eye, such as the external structures of the eye, including the cornea, or the internal structures of the eye, including the retina, inwardly through the cover 110. The lens portion 182 can act as a corrective lens for the patient, such as to correct astigmatism of the eye. The lens portion 182 can include a lens blank, such as an A8 lens blank, that can be shaped as a prescription lens for the patient. Lens portion 182 may include an interchangeable lens portion 182, e.g., a first lens portion of device 100 may be interchangeable with a second lens portion, such as to change the lens power presented to the patient. The inner surface of lens portion 182 may be treated, such as with an anti-fog coating, to prevent condensation from obscuring the patient's vision.
[0076] The cover 110 can define a sealed cavity 112, such as when placed over the eye and against the patient. The cavity 112 can define a sealed cavity 112 over both eyes, such as when the cover 110 includes a mask positioned over the patient's left eye and the patient's right eye. In one example, the cavity 112 can define a spatial volume, such as a spatial volume defined between an inner surface 188 of the cover 110 and a front surface of the patient's eye. The cavity 112 can contain a working fluid, such as a liquid or gaseous fluid, that can form an ocular environment in contact with the patient's eye. In one example, the ocular environment can be used to characterize a physiological condition of the patient's eye, for example, the ocular environment can include physiological components including biomarkers released from the eye. Information sensed by the device 100, such as biomarkers sensed from the working fluid in the cavity 112, can provide patient information to a medical professional, such as to diagnose an ocular disease associated with the patient's eye. In one example, the ocular environment can be used to treat a patient's eye, for example, device 100 can adjust the ocular environment to change at least one of the pressure or working fluid composition within cavity 112 to treat an ocular disease.
[0077] The eye disease may describe an eye condition, such as a physiological condition of the eye, that may affect the patient's vision. The eye disease may include at least one of an acute eye disease, such as an eye disease that may last for a period measured in seconds, minutes, or days, or a chronic eye disease, such as an eye disease that may last for a period measured in days, weeks, months, or years. In one example, the eye disease may include an abnormal eye disease, such as an eye condition. The eye condition may include at least one of glaucoma, optic disc edema, Fuchs dystrophy, diabetic retinopathy, macular degeneration, such as wet or atrophic macular degeneration, cataracts, dry eye, corneal infection, meibomian gland disease, Demodex, corneal ectasia, or periocular skin laxity.
[0078] Ocular diseases may be affected by device 100, such as by exposing a patient's eye, including an anterior portion of the eye, to an ocular environment within cavity 112. In one example, glaucoma may be treated, inhibited, or prevented by device 100, such as by exposing the eye to an ocular environment including a negative gauge pressure. In one example, optic disc edema may be treated, inhibited, or prevented by device 100, such as by exposing the eye to an ocular environment including a positive gauge pressure. In one example, an aerobic eye infection may be treated, inhibited, or prevented by device 100, such as by exposing the eye to an aerobic environment (e.g., an environment without oxygen), such as to address an underlying cause of the aerobic eye infection.
[0079] One or more eye disorders can be affected, such as simultaneously, by device 100 by exposing the eye to the environment within cavity 112. In one example, if a patient is suspected of having one or more eye disorders, such as glaucoma and optic disc edema, device 100 can treat, inhibit, or prevent the multiple eye disorders, such as by exposing the patient's eye to an ocular environment that includes an aerobic ocular environment at negative gauge pressure, such as a negative pressure environment for treating glaucoma and an aerobic environment for treating aerobic ocular infections.
[0080] The ocular environment may be defined by an indication of a working fluid property, such as an indication of a working fluid property within the cavity 112. The working fluid property may include at least one of a working fluid flow within the cavity 112, such as a working fluid volumetric flow rate, including at least one of a volumetric flow rate into or out of the cavity 112, a working fluid humidity within the cavity 112, such as a relative humidity of the working fluid within the cavity 112, a working fluid temperature within the cavity 112, a working fluid pressure within the cavity 112, such as a working fluid gauge pressure within the cavity 112, including a pressure difference between the working fluid pressure within the cavity and the atmospheric pressure of the environment surrounding the cavity, or a working fluid composition within the cavity 112, such as a working fluid composition measured by at least one of constituent fluid concentrations or partial fluid pressures.
[0081] The cover 110 can hold a working fluid against the patient, such as in contact with an anterior portion of the patient's eye to form an ocular environment within the cavity 112. Exposing the patient's eye to the ocular environment can affect an ocular treatment, such as at least one of a diagnostic procedure on the eye, such as a diagnostic test, or a therapeutic procedure on the eye, such as to treat, inhibit, or prevent an ocular disease associated with the eye. In one example, the ocular treatment can include at least one of exposing the eye to a working fluid pressure within the cavity 112, such as to apply a force to an anterior portion of the eye, or exposing the eye to a working fluid composition within the cavity 112, such as a working fluid comprised of one or more constituent fluids, including one or more therapeutic fluids.
[0082] The cover 110 can maintain a gauge pressure in the cavity 112, such as a fluid pressure difference between the working fluid in the cavity and the surrounding atmosphere. In one example, gauge pressure can be defined as the pressure difference between the working fluid pressure in the cavity 112 and the atmospheric pressure surrounding the cover 110. A positive gauge pressure, such as when the working fluid pressure in the cavity 112 is higher than atmospheric pressure, can provide a compressive working fluid force against the anterior surface of the eye, such as to increase intraocular pressure (IOP) in the eye. A negative gauge pressure, such as when the working fluid pressure in the cavity 112 is lower than atmospheric pressure, can provide a negative (or "vacuum") working fluid force against the anterior surface of the eye, such as to decrease IOP in the eye.
[0083] The working fluid force applied to the front surface of the eye can include a perturbation force, such as a force for a diagnostic test, that can be applied to the front surface of the eye for a period of time sufficient to allow measurement of the deflection of the eye from a first position to a second position. In one example, application of the perturbation force for a period of time measured in seconds or minutes can be sufficient for deflection measurements. The perturbation force can be generated by a positive gauge pressure in the cavity 112 to apply a positive perturbation force to the eye, such as to reduce the curvature of the eye for diagnostic tests including diagnostic measurements. The perturbation force can be generated by a negative gauge pressure in the cavity 112 to apply a negative perturbation force to the eye, such as to increase the curvature of the eye for diagnostic tests including diagnostic measurements.
[0084] The force applied to the anterior surface of the eye can include a therapeutic force, such as a force that applies a therapy regimen to the anterior surface of the eye for a period of time sufficient to treat an ocular disease, including an acute ocular disease or a chronic ocular disease. In one example, applying a therapeutic force for a period of time measured in days, weeks, months, or years can be applied depending on the ocular disease being treated. The therapeutic force can be generated by a positive gauge pressure, such as to apply a positive therapeutic compressive force to the eye, such as to increase the intraocular pressure (i.e., IOP) of the eye to inhibit, treat, or prevent an ocular disease, including optic disc edema. The therapeutic force can be generated by a negative gauge pressure, such as to apply a negative therapeutic force to the eye, such as to decrease the IOP of the eye to inhibit, treat, or prevent an ocular disease, including glaucoma.
[0085] The working fluid may be comprised of one or more constituent fluids, such as a combination of one or more liquids or gases. The working fluid may include a combination of two constituent fluids, such as a combination of gaseous nitric oxide or gaseous carbon dioxide. The constituent fluids may include a therapeutic fluid, e.g., a component of the constituent fluid may be absorbed through the eye to inhibit, treat or prevent ocular disease. For example, the working fluid may include a combination of nitrogen and nitric oxide, e.g., a nitric oxide component may be absorbed through the surface of the eye to promote vasodilation of blood vessels in the eye to treat ocular disease, including glaucoma.
[0086] The treatment fluid is carbon dioxide (CO 2 ), oxygen (O 2 ), nitric oxide (NO), ozone (O 3 ), nitrogen (N 2The therapeutic gas may include gaseous therapeutic fluids such as helium (He), hydrocarbons including fluorocarbons and perfluorocarbons, sulfur hexafluoride, cannabinoids including tetrahydrocannabinol (THC) and cannabidiol (CBD), combinations of two or more gaseous therapeutic fluids. In one example, the therapeutic gas may include a mixture of at least one of carbon dioxide, oxygen, or nitric oxide, such as for treating ocular disorders. In one example, the therapeutic gas may include a mixture of nitric oxide and oxygen, including a mixture of 50% nitric oxide and 50% oxygen, a mixture of helium and oxygen (also known as heliox), and Medical Air, including Medical Grade Air USP. In one example, the therapeutic gas mixture may include a mixture of nitric oxide and oxygen, such as a mixture of 50% nitric oxide and 50% oxygen, including gases from The BOC Group plc under the trade name ENTONOX, such as for treating ocular disorders. In one example, the therapeutic gas combination can include a mixture of helium and oxygen, such as a mixture of 21% oxygen and 79% helium, also known as heliox, for treating ocular diseases, etc. In one example, the therapeutic gas combination can include a mixture of at least one of fluorine or chlorine, for treating ocular diseases, including ocular infections, etc. In one example, the therapeutic gas combination can include a mixture of less than about 21% volume fraction of O, such as for treating aerobic ocular infections. 2 or mixtures containing a volume fraction of oxygen greater than about 21% O, such as for treating aerobic eye infections. 2 The mixture may include at least one of a mixture containing a higher volume fraction of oxygen than ambient air, such as a mixture containing
[0087] The treatment fluid may include a liquid treatment fluid, such as a treatment solution. The treatment solution may be water (H 2The therapeutic solution may include a solvent, such as a therapeutic solute, such as a therapeutic solute. The therapeutic solute may include at least one of vitamin A, a B vitamin, such as riboflavin (vitamin B2), vitamin C, vitamin D, vitamin E, beta-carotene, zinc, lutein, or folic acid. The therapeutic solution may be converted from a liquid therapeutic fluid to a gaseous therapeutic fluid, such as by a nebulizer or atomizer that forms a therapeutic mist or fog for delivery to the cavity 112 and contact with the patient's eye. In one example, the patient's eye may be exposed to a gaseous therapeutic fluid, such as a therapeutic mist including vitamin A, to achieve a first therapeutic outcome, such as treating a corneal ulcer. In one example, the patient's eye may be exposed to a gaseous therapeutic fluid, such as a therapeutic mist including riboflavin, and then exposed to an enhancing energy, such as ultraviolet light, to achieve a second therapeutic outcome, such as promoting corneal cross-linking to treat keratoconus.
[0088] The cover 110 can include a first port 114. The first port 114 can be located on a surface of the cover 110, for example, the first port 114 can extend from an outer surface 187 of the cover 110 to an inner surface 188 of the cover 110 to allow access to the ocular environment within the cavity 112. The first port 114 can include a septum, such as a flexible septum, located over the first port 114 to isolate the cavity 112 from the surrounding environment. The flexible septum can maintain a gauge pressure, such as at least one of a positive gauge pressure or a negative gauge pressure, within the cavity 112.
[0089] The flexible diaphragm can include a resealable diaphragm, such as a septum formed from a self-sealing material, including a self-sealing polymeric material, that can allow for the insertion and withdrawal of an instrument into and through the cavity 112 while maintaining a gauge pressure in the cavity 112. In one example, the resealable septum allows a hypodermic needle to be inserted and withdrawn through the resealable septum while maintaining a gauge pressure (e.g., a positive gauge pressure or a negative gauge pressure) in the cavity 112. For example, the resealable septum allows a hypodermic needle to be placed in proximity to the eye, such as to contact a therapeutic fluid with the eye, while maintaining a gauge pressure in the cavity 112.
[0090] The flexible diaphragm can include a measurement diaphragm, such as a diaphragm that enables a sensor, such as sensor 130, to sense an indication of the ocular environment in cavity 112 without contacting the ocular environment. In one example, a pressure sensor can be positioned in contact with the measurement diaphragm covering first port 114 of cover 110, such as to sense an indication of working fluid pressure in cavity 112 through the pressure measurement diaphragm.
[0091] The cover 110 may include a second port 116 extending from an outer surface 187 of the cover 110 to an inner surface 188 of the cover 110. In one example, the second port 116 may connect the cavity 112 to a pressure source 150, such as by a conduit 117.
[0092] The cover 110 may include a seal 119, such as to provide an interface between the cover 110 and the patient, including a cover-patient interface, to enhance patient comfort when wearing the device 100. The seal may also act as a barrier, such as to separate the ocular environment in the cavity 112 from the surrounding environment. The seal 119 may be attached to the periphery of the cover 110, such as at least a portion of the periphery of the cover 110. In one example, the seal 119 may extend continuously around the periphery of the cover, such as to form a sealing surface between the cover 110 and the patient to separate the volume of the cavity 112 from the surrounding environment.
[0093] The apparatus 100 can include a cavity check valve 189. The cavity check valve 189 can be located in the apparatus 100 in communication with the cavity 112, such as in at least one of the cover 110, including any surface of the cover 110, the conduit 117, the control circuit 140, or the pressure source 150. In one example, the cavity check valve 189 can be located proximate to the first port 114, such as in, on, or above the first port 114.
[0094] The cavity check valve 189 can limit the actuation fluid pressure applied to the cavity 112. In one example, the cavity check valve 189 can be used as a safety valve, such as to ensure that the pressure in the cavity 112 does not exceed a cavity pressure level that could cause eye damage. In one example, the cavity check valve 189 can limit the pressure in the cavity 112 to a target cavity pressure level.
[0095] The cavity check valve 189 can include a cracking pressure as a characteristic of the cavity check valve 189 that can control the initiation of fluid flow through the valve. In one example, the cracking pressure can indicate an inlet pressure level of the cavity check valve 189 at which fluid can begin to flow through the cavity check valve 189. The actuation fluid pressure in the cavity 112 can be limited to a target cavity pressure level by selecting or setting the cracking pressure of the cavity check valve 189, such as by selecting or setting the cracking pressure of the cavity check valve 189 to be equal to the target cavity pressure level.
[0096] The cavity check valve 189 may include a passive cavity check valve, such as a flapper valve or a poppet valve. The cracking pressure of the passive cavity check valve may be adjusted, such as by changing the dimensions of the passive cavity check valve or the components of the passive cavity check valve. In one example, the cracking pressure of the flapper cavity check valve may be adjusted, such as by changing at least one of the flapper check valve dimensions (e.g., length, width, thickness), the flapper check valve construction material (e.g., type of material, durometer of material, single or multi-layer material, valve stiffness) or the flapper check valve hinge. In one example, the cracking pressure of the poppet cavity check valve may be adjusted, such as by changing at least one of the poppet valve dimensions (e.g., spring stiffness, poppet diameter).
[0097] 2A and 2B show side views of an example of a positive pressure cavity check valve, such as a flapper valve, configured to control pressure in cavity 112 to a target positive cavity pressure level. The target positive cavity pressure level may be specified by a medical professional, such as to treat, inhibit, or prevent an eye disease. The positive pressure cavity check valve may be located on cover 110, such as on exterior surface 187 of cover 110, to allow positive pressure working fluid to flow from cavity 112 to the surrounding environment.
[0098] 2A, cavity check valve 189 can be in a closed position, e.g., working fluid cannot exit cavity 112 through cavity check valve 189 to the ambient environment. In the closed position, device 100 can maintain a positive gauge pressure environment in cavity 112, such as a positive gauge pressure level that is less than a target positive cavity pressure level. The target positive cavity pressure level can be controlled, such as by setting a cracking pressure of the positive pressure cavity check valve equal to the target positive cavity pressure level.
[0099] 2B, cavity check valve 189 can be in an open position to allow working fluid to exit cavity 112 through cavity check valve 189 to the surrounding environment, such as when the positive gauge pressure in cavity 112 is equal to or greater than the positive target cavity pressure level. In the open position, device 100 can limit the positive gauge pressure environment in cavity 112 to a pressure level approximately equal to the positive target cavity pressure level, such as to protect the eyes from excessive working fluid pressure.
[0100] 3A and 3B show side views of an example of a negative pressure cavity check valve, such as a flapper valve, configured to control pressure in cavity 112 to a negative target cavity pressure level. The negative target cavity pressure level may be specified by a medical professional, such as to treat, inhibit, or prevent an eye disease. The negative pressure cavity check valve may be located on cover 110, such as on an inner surface 188 of cover 110, to allow fluid from the surrounding environment to flow into cavity 112.
[0101] 3A, cavity check valve 189 can be in a closed position, e.g., ambient fluid cannot pass from the ambient environment through cavity check valve 189 into cavity 112. In the closed position, device 110 can maintain a negative gauge pressure environment in cavity 112, such as a negative gauge pressure level that is higher than a negative target cavity pressure level. The negative target cavity pressure level can be controlled, such as by setting a cracking pressure of the negative pressure cavity check valve equal to the negative target cavity pressure level.
[0102] 3B, cavity check valve 189 can be in an open position to allow ambient fluid to pass from the ambient environment through cavity check valve 189 into cavity 112, such as when the negative gauge pressure in cavity 112 is equal to or less than the negative target cavity pressure level. In the open position, device 100 can limit the negative gauge pressure environment in cavity 112 to a pressure level approximately equal to the negative target cavity pressure level, such as to prevent possible damage to the eye from excessive working fluid pressure.
[0103] As the patient's ocular condition changes, such as improving or worsening, the medical professional can adjust the prescribed treatment regimen, such as to change at least one of the positive or negative target cavity pressure levels. The device 100 can include a check valve assembly 190, such as a replaceable check valve assembly 190, that adjusts the target cavity pressure level in the cavity 112. In one example, the device 100 with a first check valve assembly including a first cavity check valve with a first cracking pressure set at a first target pressure level can be replaced with a second check valve assembly including a second cavity check valve with a second cracking pressure set at a second target pressure level, such as to implement a change in the prescribed patient treatment regimen including a change in the target cavity pressure level.
[0104] 4 illustrates a side view of an example of a check valve assembly 190, such as a flapper check valve assembly, in an open position. The cavity check valve assembly 190 can include a base 192 having a first face 193, a second face 194 parallel to the first face 193, a base perimeter 195 extending from the first face 193 to the second face 194, a base port 196 extending through the base 192 from the first face 193 to the second face 194, and a cavity check valve 189 located on the first face 193 above the base port 196, such as at least a portion of the base port 196.
[0105] The check valve assembly 190 can be located on the device 100 in communication with the cavity 112, such as on at least one of the cover 110, the conduit 117, the control circuit 140, or the pressure source 150, including any surface of the cover 110. The cavity check valve assembly 190 can be located in contact with the cover 110, for example, the base perimeter 195 can be in contact with at least a portion of the cover 110, such as at least one of the surface of the port 114, the outer surface 187, or the inner surface 188. The cavity check valve assembly 190, such as a positive pressure check valve assembly, can be configured to control the pressure in the cavity 112 to a positive target cavity pressure level, for example, the check valve assembly 190 can be located in the port 114 such that the cavity check valve 189 can be located outside of the cavity 112. A cavity check valve assembly 190, such as a negative pressure check valve assembly, can be configured to control the pressure in the cavity 112 to a negative target cavity pressure level, for example, the check valve assembly 190 can be located in the port 114 such that the cavity check valve 189 can be located inside the cavity 112.
[0106] Referring again to FIG. 1 , the fluid regulator 120 can regulate the flow of fluid between two reservoirs, such as the flow of fluid between the cavity 112 and a fluid source 170, such as a pressurized gas cylinder. The fluid regulator 120 can include a regulator valve, such as one that regulates the flow of fluid between a first reservoir and a second reservoir. The regulator valve can include a passive valve, such as a check valve that closes when the pressure exceeds a critical value. In one example, the fluid regulator 120 with a check valve can be located between the cover 110 and the fluid source 170, and if the pressure of the fluid source 170 exceeds a critical value, such as a pressure that may cause damage to the patient's eye, the check valve can close to isolate the pressure of the fluid source 170 from the patient's eye, such as to protect the patient's eye from excessive force. The regulator valve can include an active valve, such as an electrically operated valve, including a servo valve, or a proportional valve, such as a piezoelectrically actuated proportional valve. In one example, the regulator valve can receive a control signal, such as from a control circuit 140, to adjust the position of an electrically-modulated spool relative to the valve body, such as to regulate fluid flow through the electrically-operated valve.
[0107] The fluid regulator 120 may be attached to the fluid source 170, such as to regulate the flow of fluid from the fluid source 170 to the cavity 112. The fluid source 170 may include a fluid container, such as a storage container of pressurized gaseous fluid. The fluid source 170 may include a generator, such as a device that concentrates or distills a constituent fluid from another fluid. In one example, the generator may include a concentrator, such as an oxygen concentrator or a carbon dioxide concentrator. In one example, the generator may include an atomizer, such as an ultrasonic humidifier or an aerosolizer, that converts a liquid therapeutic fluid, such as a miscible solution or colloidal suspension, into a gaseous working fluid, such as a therapeutic mist or fog.
[0108] Fluid regulator 120 can be in communication with device 100, for example, fluid regulator 120 can be in communication with cavity 112. In one example, fluid regulator 120 can be connected to cover 110, such as by a conduit 117 that communicates directly with cover 110 through second port 116. In one example, fluid regulator 120 can be connected to conduit 117 that communicates with cover 110 by a tube connector 118, such as a Y-connector. In one example, fluid regulator 120 can be connected to control circuit 140, such as for receiving a control signal from control circuit 140 to adjust a position of a servo valve.
[0109] The sensor 130 may sense an indication of the ocular environment within the cavity 112, such as at least one of an indication of a property of a working fluid within the cavity 112, or an indication of a physiological parameter of a patient. The sensor 130 may include sensor circuitry, such as a sensor circuitry, to receive the indication of the physical parameter sensed by the sensor 130 and process the received indication, such as an indication comprising an electrical signal suitable for reception by at least one of the control circuit 140 or the pressure source 150.
[0110] The sensor 130 can be located proximate to the device 100, such as in communication with the cavity 112 or at least partially attached to the patient. In one example, the sensor 130 can be separate from the device 100. For example, the sensor 130 can include a handheld pressure gauge, such as pressed against a measuring diaphragm located over the port 114 to sense an indication of the working fluid pressure in the cavity 112. In one example, the sensor 130 can be in fluid communication with the cavity 112, for example, the sensor 130 can be located within the cavity 112 or on the control circuit 140 in fluid communication with the cavity 112. In one example, the sensor 130 can be at least partially attached to the patient, such as the surface of the eye, including the anterior surface of the eye, or the patient tissue covering the skull, including tissue over the frontal, parietal, sphenoid, temporal, cheekbone, maxilla, occipital, and mandible bones. For example, the sensor 130 may include an electroretinography device, a portion of which may include electrodes attached to patient tissue to sense indicia of electrical activity in the patient, including electrical activity associated with a pattern electroretinography (or PERG) test. The sensor 130 may be in electrical communication with a device, such as at least one of the control circuitry 140 or the pressure source 150. The sensor 130 may provide at least one of continuous or periodic (e.g., intermittent) sensing of the working fluid, such as for monitoring an indication of the ocular environment by the sensor 130, or an indication of a physiological parameter associated with the patient, such as IOP or CSFP.
[0111] The sensor 130 may include a flow sensor, such as a device that detects an indication of working fluid flow rate including at least one of a volumetric flow rate or a mass flow rate into or out of the cavity 112. The sensor 130 may include a humidity sensor, such as a device that detects an indication of a relative humidity of the working fluid in the cavity 112. The sensor 130 may include a thermometer, such as a device that detects an indication of a temperature of the working fluid in the cavity 112. The sensor 130 may include a displacement sensor, such as a device that detects an indication of displacement including an optical coherence tomography device configured to detect displacement of a structure associated with the patient's eye.
[0112] The sensor 130 may include a pressure sensor, such as a device that senses an indication of the working fluid pressure within the cavity 112. The pressure sensor may be located in proximity to the cavity 112, such as in communication with the cavity 112. In one example, the pressure sensor may be located within the cavity 112.
[0113] A static cavity pressure level within cavity 112, such as the pressure level sensed by the pressure sensor when pressure source 150 is not regulating the actuating fluid pressure within cavity 112, may be the same anywhere within cavity 112. A dynamic cavity pressure level, such as the pressure level sensed by the pressure sensor when pressure source 150 is regulating the actuating fluid pressure within cavity 112, may vary depending on the location of the pressure sensor in communication with cavity 112.
[0114] The sensor 130 may include a pressure sensor combined with another indicator, such as an indicator of an operating condition of the pressure source 150, to estimate a static cavity pressure level in the cavity 112. In one example, a pressure sensor, such as a pressure-flow sensor including a sensor capable of measuring both the working fluid pressure (static and dynamic) and the working fluid flow rate at a measurement location, may be located proximate the pressure source 150, such as an inlet or outlet port of the pressure source 150, to include circuitry, such as a sensor circuit, that senses an indicator of dynamic pressure at the pressure sensor location and receives an indicator of the operating condition of the pressure source 150, including an indicator of flow rate (e.g., pump speed may be proportional to flow rate). The pressure-flow sensor may process at least one of the indicator of dynamic pressure or the indicator of flow rate, such as to generate a control signal that the pressure source 150 may receive to achieve a static cavity pressure, such as a target pressure level, in the cavity 112. The control signal may be based on a relationship between the indicator of dynamic pressure and the indicator flow rate, such as a relationship between pressure and flow rate, including a relationship described by a pQ (e.g., pressure-flow) chart, which may take into account the operating characteristics of the pressure source 150.
[0115] In one example, the pressure sensor can be located proximate to the pressure source 150. The control circuit 140 can be configured to receive an indication of the dynamic pressure from the pressure sensor and an indication of the operating conditions of the pressure source 150, including an indication of the pump speed. The control circuit 140 can process at least one of the indication of the dynamic pressure or the indication of the operating conditions of the pressure source 150, such as to form a control signal that the pressure source 150 can receive to achieve a static cavity pressure level, such as a target pressure level, in the cavity 112.
[0116] The sensor 130 may include a concentration sensor, such as a device that senses an indication of a chemical component in the working fluid. 2 ), oxygen (O 2 ), nitric oxide (NO), ozone (O 3), nitrogen, helium (He), hydrocarbons including fluorocarbons and perfluorocarbons, sulfur hexafluoride, cannabinoids including tetrahydrocannabinol (THC) and cannabidiol (CBD), or a combination of therapeutic gases.
[0117] The sensor 130 may include a biomarker sensor, such as a device that detects an indication of a biomarker in a working fluid that includes a biomarker released from or detected in a patient's eye. The biomarker may indicate a physiological condition of the eye, such as a state of distress where medical intervention may be required. The biomarker sensor may include a volatile gas sensor, including a quartz crystal nanobalance (QCN) sensor, to detect an indication of ketones in the working fluid. The biomarker sensor may include a glucose sensor, including an optical coherence tomography (OCT) imaging system, to detect an indication of blood glucose levels in the patient. The biomarker sensor may include an oxygen sensor, including a non-invasive optical oxygen sensor, to detect an indication of oxygen in the patient's eye or in the working fluid. The biomarker sensor may include a salinity sensor, to detect an indication of dissolved salts in the patient's eye or in the working fluid. The biomarker sensor can include an aptamer-based sensor, such as one that detects an indicator of vascular endothelial growth factor (i.e., VEGF) in the patient's eye or in the working fluid. The biomarker sensor can include an enzyme sensor, such as one that detects an enzyme, including matrix metallopeptidase 9 (MPP-9) enzyme, in the patient's eye or in the working fluid. The biomarker sensor can include a protein sensor, such as one that detects a protein, including brain-derived neurotrophic factor (BDNF) protein, in the patient's eye or in the working fluid.
[0118] The sensor 130 may include a biosensor, such as a sensor configured to sense an indication of a physiological parameter associated with the patient. The physiological parameter may include an indication of a physiological process associated with the patient, such as a process associated with the patient's eye or a process associated with the physiological activity of the patient's eye. In one example, the physiological parameter may include at least one of an indication of intraocular pressure (IOP) in the patient's eye (e.g., an IOP level), an indication of cerebrospinal fluid pressure (CSFP) associated with the patient (e.g., a CSFP level), an indication of cardiac activity, such as at least one of systemic blood pressure or heart rate. The physiological parameter may include an indication of retinal activity, as measured by an electroretinogram device, including a pattern electroretinogram (or PERG) device.
[0119] The control circuitry 140 can enable and regulate the operation of the device 100. In one example, the control circuitry 140 can be communicatively coupled to, such as coupled to, at least one of the fluid regulator 120, the sensor 130, the pressure source 150, or the fluid source 170.
[0120] The control circuit 140 may include a data interface configured to receive signals, such as at least one of an indicator of the ocular environment sensed by the sensor 130. In one example, the sensed indicator may include at least one of an indicator of the ocular environment, such as an indicator sensed from the sensor 130, or an indicator of a relationship between an indicator of a left ocular environment and an indicator of a right ocular environment. The control circuit 140 may process the received signals, such as into a processed signal, and transmit the processed signal to one or more components of the device 100. The control circuit 140 may communicate with the fluid regulator 120, such as to adjust a position of a regulator valve to control the working fluid composition. The control circuit 140 may communicate with the sensor 130, such as to receive and process indicators of the ocular environment, including sensed data from the sensor 130. The control circuit 140 may communicate with a pressure source 150, such as to adjust at least one of a working fluid pressure or a working fluid flow rate in the device 100.
[0121] The control circuitry 140 may provide a communication interface, such as to allow a user to operate and interact with the device 100. The communication interface may include a graphical user interface (i.e., GUI), such as to convey information to or receive information from the user, including information about the device 100 (e.g., readings of detected indicators, fault status, etc.). The information received from the user may include at least one of information for managing basic functions of the device 100, such as cycling power to the device 100, or an indication of user preferences, such as operating parameters including target levels defining a treatment protocol and safety parameters such as maximum and minimum limits. In one example, the communication interface may receive a safety pressure level, such as at least one of a maximum or minimum pressure level in the cavity 112 selected by the user to prevent damage to the patient's eye.
[0122] The control circuitry 140 may include a data acquisition unit (or DAC) that monitors and records indices, such as indices of the ocular environment sensed by the sensor 130. Indices of the ocular environment may be monitored and recorded by the control circuitry 140 over a period of time, such as a period of seconds, minutes, hours, days, years, or the lifespan of a patient.
[0123] The control circuitry 140 may include a processing unit, such as a programmable central processing unit (CPU). The CPU may execute instructions that implement a method of using the device 100, such as to treat, inhibit, or prevent an eye disease in a patient. In one example, the CPU may be a component of a computer, such as computer 1500.
[0124] The CPU can be configured as a control circuit, such as a feedback control circuit, that can receive information, such as at least one of an indication sensed by the sensor 130, an indication of a user preference from the communication interface, or an indication of a processed signal, including a signal processed by the CPU, and process the sensed indication, such as to form a control signal.
[0125] The CPU may be configured as a pressure feedback control circuit, such as generating a control signal (e.g., a pressure source control signal) to the pressure source 150 to adjust the pressure level within the cavity 112, such as based on an indication of the cavity pressure level from a pressure sensor in communication with the cavity 112.
[0126] In one example, the pressure source control signal may be based on an indication of a cavity pressure, such as the pressure in cavity 112, to achieve a target pressure level in cavity 112. The pressure feedback control circuit may receive an indication of the working fluid pressure in cavity 112, such as an indication of a cavity pressure level sensed by a sensor 130 that includes a pressure sensor in communication with cavity 112. The pressure feedback control circuit may process the received indication of the pressure level to form a control signal, such as a control signal that adjusts pressure source 150 to achieve the target pressure level in cavity 112.
[0127] Processing the received indication of pressure may include calculating an indication, such as calculating an indication of a difference between the indication of the cavity pressure level and an indication of a user preference, including a cavity pressure setpoint level received from the communication interface to form an indication of a cavity pressure differential value. Processing the received indication may include generating a control signal based on the indication of the cavity pressure differential value by a proportional-integral-derivative (PID) control algorithm executing on the CPU to regulate the pressure source 150. Generating the control signal may include generating a control signal that minimizes the difference between the indication of the received pressure level and the cavity pressure setpoint level.
[0128] In one example, the pressure source control signal can be based on an indication of a physiological parameter associated with the patient, such as an indication of IOP in the patient's eye, to achieve a target IOP level in the patient's eye. The pressure feedback control circuit can receive an indication of an IOP level in the patient's eye, such as an indication of an IOP level sensed by a sensor 130 that includes a biosensor configured to sense IOP. The pressure feedback control circuit can process the received indication of the IOP level to form a control signal, such as a control signal to adjust the pressure source 150 to achieve a target cavity pressure level in the cavity 112, such as a target cavity pressure level sufficient to achieve the target IOP level in the patient's eye.
[0129] Processing the received indication of IOP may include calculating a difference between the indication of IOP level and an indication of user preferences, including an IOP setpoint level, received from the communications interface to generate an IOP difference value. Processing the received indication may include generating a control signal based on the IOP difference value by a proportional-integral-derivative (PID) control algorithm executing on the CPU to regulate pressure source 150. Generating the control signal may include generating a control signal that minimizes a difference between the received indication of pressure level and the cavity pressure setpoint level.
[0130] The CPU can be configured as a concentration feedback control circuit to generate regulator control signals that adjust the chemical component levels within the cavity 112 . In one example, the regulator control signal can be based on an indication of a chemical constituent associated with the working fluid, such as an indication of nitric oxide (NO) concentration, to achieve a target NO concentration level in the working fluid. The concentration feedback control circuit can receive an indication of an NO concentration level in the working fluid, such as an indication of an NO level sensed by a sensor 130 that includes a concentration sensor configured to detect NO. The concentration feedback control circuit can process the received indication of the NO level to form a control signal, such as a control signal that adjusts regulator 120 to achieve a target NO concentration level in cavity 112.
[0131] Processing the received indication of NO concentration may include calculating a difference between the indication of NO concentration and an indication of user preferences, including an NO setpoint level, received from the communications interface to generate a NO difference value. Processing the received indication may include generating a control signal based on the NO difference value. Processing the received indication may include generating a control signal based on the NO difference value by a proportional-integral-derivative (PID) control algorithm executing on the CPU to regulate regulator 120. Generating the control signal may include generating a control signal that minimizes the difference between the received indication of NO concentration and the NO setpoint level.
[0132] The control circuit 140 may include a pressure source circuit, such as a pressure source circuit configured to adjust operation of the pressure source 150 based on at least one of the indicators sensed by the sensor 130. The pressure source circuit may include a pressure source logic circuit, such as a pressure source logic circuit configured to generate a system fault based on at least one of the sensed indicators received at the data interface or an indicator of a user preference received through the communication interface. In one example, the pressure source logic circuit may generate a system fault upon occurrence of a fault event, such as when an indicator of cavity pressure in the cavity 112 exceeds a pressure safety level, such as a pressure safety level set by a user through the communication interface.
[0133] The control circuitry 140 can include a power source to provide electrical energy to the device 100. In one example, the power source can include a battery, such as a lithium ion battery, and a transformer, such as to receive power from a wall outlet for use in the device 100 at a specified voltage and current. The control circuitry 140 can include a heating element, such as a heating element in communication with the treatment fluid, including a heating element located on a surface of the cover 110, including the inner surface 188 of the cover 110, that increases the temperature of the treatment fluid.
[0134] The pressure source 150 may be configured to generate a volumetric fluid flow within the device 100, such as to move the working fluid from the pressure source 150 to the cavity 112 or to move the working fluid from the cavity 112 to at least one of the pressure source 150 or the ambient environment. The pressure source 150 may be configured to apply a non-atmospheric pressure to the cavity 112, such as to adjust an indication of the fluid pressure, including an indication of the pressure level within the cavity 112, from a first pressure level to a second pressure level different from the first pressure level.
[0135] The pressure source 150 can include a pump, such as a pump capable of generating at least one of a positive gauge pressure or a negative gauge pressure. The pressure source 150 can include a powered pressure source, such as a pump including a positive displacement pump or a centrifugal pump. For example, the pressure source 150 can include a diaphragm vacuum pump. The pressure source 150 can include a manual pressure source, such as a hand pump including a bellows-style pump. In one example, the pressure source 150 can be integrated into a component of the device 100, such as the cover 110.
[0136] 1A illustrates an example of an apparatus 101 that includes an example of a manual pressure source. In one example, apparatus 101 can include all of the components of apparatus 100. Apparatus 101 can include a bellows cover 111, such as at least one of a left bellows cover 111A or a right bellows cover 111B, a cavity check valve 189, such as at least one of a left cavity check valve 189A or a right cavity check valve 189B, and a seal 119, such as at least one of a left seal 119A or a right seal 119B.
[0137] The bellows cover 111 can be sized and shaped to surround and be spaced from the patient's eye, such as without contacting the eye, including the front of the eye. The bellows cover 111 can be sized and shaped to surround and cover both of the patient's eyes, such as the patient's left and right eyes. In one example, the bellows cover 111 can include a mask, such as a bellows cover 111 similar in shape and function to a diving or snorkeling mask.
[0138] The bellows cover 111 can include a bellows portion, such as a portion of the bellows cover 111 between the lens 182 and the seal 119. The bellows portion can assume a first bellows position, such as defined by a first bellows distance between the lens 182 and the seal 119. The bellows portion can assume a second bellows position, such as a position displaced from the first bellows position. The bellows portion can exhibit resistance to movement, e.g., an external force can be required to displace the bellows portion from the first bellows position to the second bellows position. The level of resistance to movement can be controlled, e.g., through selection of bellows material and design of the bellows portion, including the number of bellows folds. The bellows portion can exhibit resiliency, e.g., a tendency of the bellows portion to recover to an equilibrium position, including a force equilibrium position, after removal of the external force.
[0139] The second bellows position can include a compressed bellows position to generate a negative gauge pressure (e.g., a vacuum) on the patient's eye. In one example, the distance between the lens 182 and the seal 119 can be reduced from a first bellows position when a compressive force is applied to the bellows cover 111 to a compressed bellows position, or the like. When the bellows cover 111 moves from the first bellows position to the compressed bellows position, the volume of the cavity 112 can be reduced, such as to increase the working fluid pressure in the cavity 112, which can then evacuate a volume of working fluid from the cavity 112, such as through the check valve 189. When the compressive force is removed, the resilience of the bellows portion can restore the third bellows position, such as between the first bellows position and the compressed bellows position, such as to provide a "suction" or negative gauge pressure on the patient's eye.
[0140] The second bellows position can include an extended bellows position to generate a positive gauge pressure (e.g., an increase in pressure compared to atmospheric pressure) on the patient's eye. In one example, the distance between the lens 182 and the seal 119 can increase from the first bellows position to the extended bellows position, etc., when an expansion force is applied to the bellows cover 111. When the bellows cover 111 moves from the first bellows position to the extended bellows position, the volume of the cavity 112 can increase, such as to reduce the working fluid pressure in the cavity 112, and the cavity 112 can then receive a volume of ambient air from the surrounding environment, such as through the check valve 189. When the external force is removed, the resilience of the bellows portion can restore the third bellows position, such as a position between the first bellows position and the extended bellows position, such as to provide a "pressurized" or positive gauge pressure on the patient's eye.
[0141] Pressure source 150 can include a pressure source, such as a pressurized gas cylinder, or a source of pressurized fluid separate from apparatus 100 that can be used to regulate the working fluid pressure in cavity 112. Pressure source 150 can include a pressure source used in combination with an auxiliary device to regulate the pressure in the cavity. In one example, pressure source 150 can include a Venturi-type pump, such as a Venturi jet pump, in combination with a pressure source to regulate the fluid pressure in cavity 112.
[0142] The pressure source 150 may be characterized by a physical characteristic, such as a relationship between physical characteristics. A useful criterion for comparing the performance of several sources of flow includes a volume-pressure characteristic, such as a relationship between the volume of working fluid flow from the source and the pressure, such as a static pressure, resulting from the fluid flow. In one example, the pressure source 150 may be characterized by a volume-pressure characteristic, such as a pQ chart.
[0143] The pressure source 150 can generate a pressure in the cavity 112, such as to adjust the pressure in the cavity 112 to move toward or achieve a target cavity pressure in the cavity 112. The target cavity pressure can include a cavity pressure that affects a measurement procedure, including a diagnostic procedure, on the patient's eye. In one example, the pressure in the cavity 112 can be adjusted by the pressure source 150 toward a target cavity pressure, such as a first target cavity pressure that affects a first displacement of the anterior surface of the patient's eye. An indication of the first displacement can be sensed by the sensor 130, which includes a displacement sensor. A second target cavity pressure can then affect a second displacement of the anterior surface of the patient's eye, such as an indication of a second displacement that can be sensed by the displacement sensor. A difference between the indications of the displacement between the first and second target pressures can provide an estimate of a physiological parameter, such as an estimate of an indication of IOP in the patient's eye.
[0144] The target cavity pressure may include a cavity pressure that affects a treatment of the patient's eye, such as a cavity pressure prescribed by a medical professional to treat, inhibit or prevent an ocular disease. In one example, the pressure in cavity 112 may be adjusted by pressure source 150 toward a target cavity pressure that affects an indicator of a physiological parameter of the patient's eye, including an indicator of an IOP level in the patient's eye that may be detected by sensor 130 that includes a biosensor configured to detect an indicator of IOP. A treatment of the patient's eye may be affected by pressure source 150, such as by adjusting the pressure source to achieve a target cavity pressure in cavity 112 that affects a desired indicator of an IOP level in the patient's eye.
[0145] The target cavity pressure can include a target IOP cavity pressure, such as a pressure applied to the cavity 112 to achieve a target IOP level in the patient's eye. The target IOP cavity pressure can include a cavity pressure that can adjust or achieve an IOP level in the patient's eye, such as to increase or decrease the IOP level in the patient's eye. The target IOP levels can include an IOP level in the range of about 5 mmHg to about 30 mmHg, an IOP level in the range of about 10 mmHg to about 21 mmHg, and an IOP level in the range of about 12 mmHg to about 18 mmHg.
[0146] Translaminar pressure describes the pressure difference across the lamina cribrosa. Translaminar pressure difference (TPD) can be defined as the difference between the intraocular pressure in a patient's eye and the cerebrospinal fluid pressure in the patient's body. Translaminar pressure gradient (TPG) is related to TPD and can be defined as the difference between IOP and CSFP per unit thickness of the lamina cribrosa. Indications of TPD, such as TPD levels, can indicate the physiological health of a patient's eye, such as the presence or absence of ocular disease. A physiologically normal eye, such as a patient's eye without ocular disease, can be characterized by a normal TPD level, such as a normal TPD level ranging from about -4 mHg to about 4 mmHg. In contrast, non-normal eyes, such as patient eyes with eye diseases including glaucoma, can be characterized by TPD levels that are outside the range of normal TPD levels, for example, such TPD levels can be less than about -4 mmHg or greater than about 4 mmHg.
[0147] The target cavity pressure can include a target equalization cavity pressure, such as a pressure applied to the cavity 112 that can equalize the TPD level in the eye. The cavity pressure that can equalize the TPD level in the eye can include any pressure applied to the cavity 112 that can reduce the TPD level in the eye, such as from a first TPD level to a second TPD level, including where the absolute value of the second TPD level can be less than the absolute value of the first TPD level.
[0148] The target cavity pressure may include a target transcriba pressure difference (TPD) cavity pressure, such as a pressure applied to the cavity 112 that can achieve a target TPD level in the patient's eye. The target TPD cavity pressure may include a pressure level applied to the cavity 112 sufficient to adjust the TPD level of the patient's eye to a range, such as a target TPD level range. The target TPD level range may include at least one of a TPD level range of about -4 mmHg to about 4 mmHg, a TPD level range of about -7 mmHg to about 7 mmHg, or a TPD level range of about -10 mmHg to about 10 mmHg. In one example, the normal TPD level range may include a TPD level range of about -4 mmHg to about 4 mmHg.
[0149] Adjusting the TPD, such as adjusting the TPD in the patient's eye from a first TPD level to a second TPD level lower than the first TPD level, can improve physiological processes in the patient's eye, such as to improve the health of the patient's eye. Axonal transport, such as a collection of cellular processes responsible for maintaining cellular viability in the patient's optic nerve, can be adversely affected by the presence of elevated TPD, such as when the indication of TPD in the patient's eye is not within a normal TPD level range. Indications of axonal transport levels, such as in the optic nerve, can be sensed by a sensor 130 that includes an axonal transport sensor. In one example, the axonal transport sensor can include at least one of an optical coherence tomography (OCT) imaging system or a confocal scanning laser ophthalmoscope (CSLO) system.
[0150] The target cavity pressure can include a target axonal transport cavity pressure, such as a cavity pressure applied to cavity 112 to achieve a target axonal transport level in the patient's eye. The target axonal transport cavity pressure can include a cavity pressure that can improve (or increase) an indicator of an axonal transport level in the eye, such as from a first indicator of an axonal transport level to a second indicator of an axonal transport level, where the second indicator of an axonal transport level can be higher than the first indicator of an axonal transport level.
[0151] The rate of axonal transport may vary based on the physiological component being transported, etc. In one example, "slow" axonal transport may refer to the movement of cytoplasmic components along the axon, including, for example, the cytoskeleton of intermediary metabolism and soluble enzymes. Target axonal transport levels for slow axonal transport components, etc. may include axonal transport levels ranging from about 0.2 mm / day to about 2 mm / day. In one example, "fast" axonal transport may refer to the movement of mitochondrial polypeptides, such as synaptic vesicle polypeptides, and neuropeptides along the axon. Target axonal transport levels for fast axonal transport components, etc. may include axonal transport levels ranging from about 50 mm / day to about 100 mm / day for mitochondrial polypeptides, etc., and axonal transport levels ranging from about 100 mm / day to about 200 mm / day for neuropeptides, etc.
[0152] The target cavity pressure may include a target treatment cavity pressure that treats, inhibits, or prevents an ocular disease in a patient's eye. A target treatment cavity pressure for treating an ocular disease can include a cavity pressure selected to modulate an indicative physiological parameter, such as a physiological parameter sensed by the sensor 130. In one example, modulating the indicative physiological parameter can include alleviating a subjective patient symptom, such as alleviating patient discomfort, or improving patient function, such as patient function impaired by an ocular disease or condition.
[0153] The target treatment cavity pressure for inhibiting ocular disease can include a cavity pressure selected to maintain patient function, such as to halt or slow further decline in patient function due to a diagnosed ocular disease. In one example, maintaining a measure of patient function can include minimizing fluctuations in a measure of a physiological parameter of the patient's eye. For example, the target treatment cavity pressure for inhibiting ocular disease can include a cavity pressure selected to minimize fluctuations in a measure of IOP over a period of time.
[0154] The target treatment cavity pressure for preventing ocular disease can include a cavity pressure selected as a preventative measure applied to the patient's eye before the ocular disease manifests. In one example, for a patient exhibiting a prognostic characteristic for ocular disease, such as an abnormal cup-to-disc ratio as a potential indicator of glaucoma, the device 100 can apply a cavity pressure to the patient's eye, such as at a pressure level suitable for the patient's physiology, such that the physiological process does not progress to a clinical diagnosis of ocular disease. Thus, the target cavity pressure level can include a cavity pressure level sufficient to adjust the cup-to-disc diameter ratio in the patient's eye from a first cup-to-disc diameter ratio to a second cup-to-disc diameter ratio lower than the first cup-to-disc diameter ratio, such as to reduce the cup-to-disc diameter ratio in the patient's eye.
[0155] The conduit 117 may provide a patient fluid transmission path between one or more components of the device 100, such as a continuously open fluid transmission path between the cavity 112 and at least one of the sensor 130 or the cavity 112 and the pressure source 150. The conduit 117 may include lumens, such as one or more lumens.
[0156] 5A illustrates a cross-section of an example of a conduit 117, such as a first dual lumen conduit. The first dual lumen conduit can include a first lumen 113A defined by a first lumen wall 115A and a second lumen 113B defined by a second lumen wall 115B, e.g., the first lumen 115A can be located adjacent to the second lumen 115B. In one example, the first lumen 113A can provide a fluid communication path between a pressure source 150 and the cavity 112, e.g., the pressure source 150 can transport a working fluid through the lumen 113A to the cavity 112 to achieve a target cavity pressure level. In one example, the second lumen 113B can provide a fluid communication path between the cavity 112 and a sensor 130, such as an actuating fluid pressure sensor located in the control circuit 140, such that the sensor 130 can detect an indication of the cavity pressure level within the cavity 112, such as for use as a feedback signal to control the operation of the pressure source 150.
[0157] Potential operational hazards of device 100 may include occlusion of conduit 117, such as a condition of conduit 117 that may interrupt a patent fluid transmission path, including a kink in conduit 117. In one example, a kink may include an occlusion, such as an occlusion due to a bending force applied to conduit 117, where at least one of first lumen 113A or second lumen 113B may fold and collapse, e.g., a first portion of an inner surface of the lumen may contact a second portion of an inner surface of the lumen, preventing fluid transmission through the lumen. A kink in conduit 117 between cavity 112 and a sensor 130, such as an actuating fluid pressure sensor located in control circuit 140, may result in the pressure source 150 becoming uncontrollable, e.g., control circuit 140 may command pressure source 150 to generate a cavity pressure level based on an erroneous indication of cavity pressure level from sensor 130.
[0158] In one example, a kink in the first lumen 113A may cause fluid communication between the cavity 112 and the actuating fluid pressure sensor to cease, for example, causing the actuating fluid pressure sensor to sense an erroneous indication of the cavity pressure level, including no cavity pressure level (e.g., an indication of a cavity pressure level of about 0 mmHg gauge). The erroneous indication of the cavity pressure level may cause the control circuit 140 to command the pressure source 150 to adjust, e.g., increase or decrease, fluid transfer to the cavity 112, such as to operate the pressure source 150 to compensate for the cavity pressure level in the cavity 112, such as to achieve or maintain a target cavity pressure level. Continued detection of the erroneous indication of the cavity pressure level may cause the pressure source 150 to operate in a "runaway" (i.e., uncontrolled) condition, such as to generate cavity pressure levels that may be damaging to the patient's eye. To avoid a runaway condition, the conduit 117 may include features, such as one or more features designed to improve the safety of the device 100, such as the operational safety of the device 100 due to blockage of the conduit 117.
[0159] FIG. 5B shows a cross-section of an example of a second dual lumen conduit, such as conduit 117, in which the first lumen wall 115A can contact the second lumen wall 115B, such as to form a first lumen 113A and a second lumen 113B within the second lumen wall 115B.
[0160] FIG. 5C shows an example of a third dual lumen conduit, such as conduit 117, in which the first lumen 113A can be located entirely within the second lumen 113B, e.g., the first lumen wall 115A can be separate from the second lumen wall 115B.
[0161] The patency of the conduit 117 can be controlled, such as by the orientation of the first lumen 113A relative to the second lumen 113B. In one example, a kink in a conduit 117, such as at least one of the example conduits 117 shown in Figure 5B or 5C, can occlude the first lumen 113A, such as by preventing fluid transfer from the pressure source 150 to the cavity 112, but can leave the second lumen 113B open and prevent the second lumen 113B from collapsing, such as by preventing an outer surface of the first lumen wall 115A from contacting a first portion of the inner surface of the second lumen 113B with a second portion of the inner surface of the second lumen 113B.
[0162] The patency of the conduit 117 can be controlled, such as by the design of the conduit 117, including the design of at least one of the first lumen 113A or the second lumen 113B. The dimensions of the conduit 117 can be selected, such as to maintain the patency of the second lumen 113B. In one example, the thickness of the first lumen wall 115A can be different from the thickness of the second lumen wall 115B, such as to prevent a first portion of the second lumen 113B from collapsing, such as when the conduit 117 is subjected to a bending force. The material used to construct the conduit 117 can be selected to maintain the patency of the second lumen 113B. In one example, the type or durometer of the material used to form the first lumen wall 115A can be different from the type or durometer of the material used to form the second lumen wall 115B, such as to prevent a first portion of the second lumen 113B from collapsing, such as when the conduit 117 is subjected to a bending force.
[0163] Conduit 117 may include a reinforcing structure, such as to prevent blockage of at least one of first lumen 113A or second lumen 113B. The reinforcing structure may include a coil of wire, such as a wire coil, located in and extending around at least one of first lumen wall 115A or second lumen wall 115B.
[0164] The cross-sectional shape of the conduit 117 can assume any shape that does not affect the function of the conduit 117. The cross-sectional shape of the conduit 117, such as the cross-sectional shape of the first lumen 113A and the cross-sectional shape of the second lumen 113B, can include at least one of a circle, an ellipse, a crescent, a triangle, a rectangle, or any polygonal cross-sectional shape.
[0165] The flexibility of the conduit 117 can be controlled, such as the overall stiffness of the conduit 117 due to the stiffness of the first lumen wall 115A and the second lumen wall 115B. In one example, the stiffness of the conduit 117 can be reduced by a structural configuration of the conduit 117, such as a structural configuration that minimizes a moment of inertia associated with the cross-sectional shape of the conduit 117. For example, a first dual lumen conduit having a first moment of inertia or the like can demonstrate a higher overall stiffness, such as in bending or torsion, when compared to at least one of a second dual lumen conduit having a second moment of inertia or a third dual lumen conduit having a third moment of inertia, such as where the first moment of inertia can be greater than the second moment of inertia or the third moment of inertia. In one example, the second dual lumen conduit or the third dual lumen conduit can minimize a torsional bias, such as a torsional bias that may result from at least one of bonding or extrusion, when compared to the first dual lumen conduit.
[0166] 6 illustrates an example of an apparatus 600 that can control an ocular environment on a patient's eye, such as at least one of a left ocular environment on a patient's left eye or a right ocular environment on a patient's right eye. Controlling the ocular environment can include at least one of establishing, adjusting or maintaining an indicator of the ocular environment on the patient's eye, such as an indicator of the working fluid cavity pressure in cavity 112. In an example, controlling the left ocular environment can be independent of the right ocular environment and controlling the right ocular environment can be independent of the left ocular environment.
[0167] The device 600 can include a left system 602 comprising a left cover 110A sized and shaped to fit over a patient's left eye to define a left cavity 112A between the left cover 110A and the front of the left eye, a right system 604 comprising a right cover 110B sized and shaped to fit over a patient's right eye to define a right cavity 112B between the right cover 110B and the front of the right eye, a bridge 606 for positioning the left system 602 relative to the right system 604, etc. In one example, the left system 602 can include at least one of the devices 100, and the right system 604 can include at least one of the devices 100.
[0168] The device 600 may include system control circuitry 640 that facilitates, coordinates, and controls the operation of the device 600. The system control circuitry 640 may be configured to receive and process an indicator of an ocular environment, such as at least one of an indicator of a left ocular environment, an indicator of a right ocular environment, or an indicator of a relationship between the indicator of the left ocular environment and the indicator of the right ocular environment.
[0169] The system control circuitry 640 may include at least one of a left control circuitry 140A, such as a left control circuitry 140A, that enables, regulates and controls the operation of the left system 602, or a right control circuitry 140B, such as a right control circuitry 140B, that enables, regulates and controls the operation of the right system 602. In one example, the left control circuitry 140A may be configured to control the operation of the left system 602 independently of the right system 604, and the right system 604 may be configured to control the operation of the right system 604 independently of the left system 602. In one example, the left control circuitry 140A may be capable of receiving and processing at least one of an indication of a left eye environment or an indication of a relationship between the left eye environment and the right eye environment. In one example, the right control circuitry 140B may be capable of receiving and processing at least one of an indication of a right eye environment or an indication of a relationship between the left eye environment and the right eye environment.
[0170] The system control circuit 640 can include a pressure source circuit, such as a pressure source circuit configured to adjust operation of the pressure source based on at least one of an indicator of a left ocular environment, an indicator of a right ocular environment, or an indicator of a relationship between the indicator of the left ocular environment and the right ocular environment. In one example, the pressure source circuit can include at least one of a left pressure source circuit, as coupled to the left control circuit 140A, or a right pressure source circuit, as coupled to the right control circuit 140B.
[0171] The pressure source circuit can include a pressure source logic circuit, such as a pressure source logic circuit, configured to generate a system fault based on at least one of the received indicators, such as indicators received by the system control circuitry 640. In one example, the pressure source logic circuit can generate a system fault upon occurrence of a fault event, such as at least one of an indicator of left pressure in the left cavity 112A exceeding a left pressure safety level or an indicator of right pressure in the right cavity 112B exceeding a right pressure safety level. In one example, the pressure source logic circuit can generate a system fault if a relationship between an indicator of left eye environment and an indicator of right eye environment exceeds a "relevant safety level." For example, the pressure source logic circuit can generate a system fault if a difference between an indicator of pressure in the left cavity 112A and an indicator of pressure in the right cavity 112B exceeds a relevant safe pressure level. The relevant safe pressure level can be defined by a user, such as by a communication interface associated with the control circuitry 140.
[0172] The system control circuitry 640 can be configured to enable, coordinate, and control operation of the device 600, such as in a master-slave control configuration. As an example, a first control circuitry can receive and process indicators of the ocular environment, and a second control circuitry can communicate with the first control circuitry to receive the processed indicators from the first control circuitry and coordinate operation of the device 600, such as at least one of the left system 602 or the right system 604. In one example, the first control circuitry can include the left control circuitry 140A and the second control circuitry can include the right control circuitry 140B. In one example, the first control circuitry can include the right control circuitry 140B and the second control circuitry can include the left control circuitry 140A.
[0173] In one example, the left control circuit 140A can control the cavity pressure in the left cavity 112A, such as by adjusting the left pressure source 150A to achieve a target cavity pressure in the left cavity 112A. For example, the left control circuit 140A can include a control mechanism, such as a feedback control mechanism, based on an indication of a physiological parameter from the left sensor 130A, such as an indication of an IOP level in the left eye sensed by the left biosensor, and be configured to process the received physiological parameter, such as to adjust the left pressure source 150A to achieve a target cavity pressure level in the left cavity 112A based on the received physiological parameter, such as the received indication of the left IOP level.
[0174] In one example, the left control circuit 140A can control the left working fluid composition in the left cavity 112A, such as by adjusting the left fluid regulator 120A to achieve a target fluid composition in the left cavity 112A. For example, the left control circuit 140A can receive an indication of the left ocular environment from the left sensor 130A, such as an indication of nitric oxide (NO) levels in the left cavity sensed by a left NO concentration sensor, and process the received indication of the left ocular environment, such as to adjust the left fluid regulator 120A to achieve a target fluid concentration level in the cavity 112A based on the received physiological parameter, such as the received indication of NO levels in the left cavity 112A.
[0175] The right control circuit 140B can enable, regulate and control the operation of the right system 604, including the right eye environment within the right cavity 112B, independently from the left control circuit 140A. For example, right control circuit 140B can control at least one cavity pressure in right cavity 112B, such as by adjusting right pressure source 150B to achieve a target cavity pressure in cavity 112B, or the right working fluid composition, such as by adjusting right fluid regulator 120B to achieve a target fluid composition in cavity 112B.
[0176] Apparatus 600 can control the left-eye environment in left cavity 112A separately from the right-eye environment in right cavity 112B, and can control the right-eye environment in right cavity 112B separately from the left-eye environment in left cavity 112A. In one example, left system 602 can control at least one of left cavity pressure or left working fluid concentration in left cavity 112A independently from right system 604, and right system 604 can control at least one of right cavity pressure or right working fluid concentration in right cavity 112B independently from left system 602.
[0177] The left eye environment can include the left cavity pressure in the left cavity 112A as sensed by the left pressure sensor 130A through the left conduit 117A. The right eye environment can include the right cavity pressure in the right cavity 112B as sensed by the right pressure sensor 130B through the right conduit 117B.
[0178] In one example, the left pressure source 150A can establish, regulate, maintain, etc., control, a left cavity pressure in the left cavity 112A. For example, the left pressure source 150A and the left fluid regulator 120A can be in communication with the left cavity 112A, such as through a second left port 116A, to generate a left positive gauge pressure in the left cavity 112A, such as for delivering a makeup fluid from the left fluid regulator 120A into the left cavity 112A. The left cavity check valve 189A in communication with the left cavity 112A can be configured to limit the left cavity pressure in the left cavity 112A to a target left cavity pressure level, such as including a target positive left cavity pressure level or a target negative left cavity pressure level.
[0179] In one example, the right pressure source 150B can establish, regulate, maintain, etc., control a first right cavity pressure in the right cavity 112B. For example, the right pressure source 150B and the right fluid regulator 120B can communicate with the right cavity 112B, such as through the second right port 116B, to generate a right positive gauge pressure in the right cavity 112B, such as to deliver a makeup fluid from the right fluid regulator 120B into the right cavity 112B. The right cavity check valve 189B in communication with the right cavity 112B can be configured to limit the right cavity pressure in the right cavity 112B to a target right cavity pressure level, etc. In one example, the first left cavity pressure can be adjusted, such as increased or decreased, independently of the right pressure source 150B, and the first right cavity pressure can be adjusted, such as increased or decreased, independently of the left pressure source 150A.
[0180] The left eye environment can include a left working fluid composition in the left cavity 112A, and the right eye environment can include a right working fluid composition in the right cavity 112B. In one example, the left fluid regulator 120A can control a first left working fluid composition in the left cavity 112A. In one example, the right fluid regulator 120B can control, e.g., establish and maintain, a first right working fluid composition in the right cavity 112B. In one example, the first left working fluid composition can be adjusted, e.g., increasing or decreasing a concentration of a component of the first left working fluid, independently of the right fluid regulator 120B, and the first right working fluid composition can be adjusted, e.g., increasing or decreasing a concentration of a component of the first right working fluid, independently of the left fluid regulator 120A.
[0181] The device 600 can sense a left eye environment on the left eye with a left sensor 130A, etc., and a right eye environment on the right eye with a right sensor 130B, etc. In one example, the left sensor 130A can sense the left eye environment independent of the right environment, and the right sensor 130B can sense the right eye environment independent of the left environment.
[0182] In one example, a left sensor 130A, such as a left cavity sensor in communication with the left cavity 112A, can sense an indication of the left ocular environment within the left cavity 112A. The left cavity sensor can include at least one of a left flow sensor to sense an indication of fluid flow within the left cavity 112A, a left humidity sensor to sense an indication of humidity within the left cavity 112A, a left temperature sensor to sense an indication of temperature within the left cavity 112A, a left pressure sensor to sense an indication of pressure within the left cavity 112A, or a left composition sensor to sense an indication of working fluid composition, such as working fluid component concentrations, within the left cavity 112A.
[0183] In one example, a right sensor 130B, such as a right cavity sensor in communication with the right cavity 112B, can sense an indication of a right ocular environment in the right cavity 112B. The right cavity sensor can include at least one of a right flow sensor to sense an indication of a fluid flow rate in the right cavity 112B, a right humidity sensor to sense an indication of a humidity in the right cavity 112B, a right temperature sensor to sense an indication of a temperature in the right cavity 112B, a right pressure sensor to sense an indication of a pressure in the right cavity 112B, or a right working fluid composition, such as a right working fluid component concentration. In one example, the left sensor 130A can sense an indication of a left ocular environment in the left cavity 112A independently of the right sensor 130B, and the right sensor 130B can sense an indication of a right ocular environment in the right cavity 112B independently of the left sensor 130A.
[0184] 7, the device 600 can process, via the control circuitry 140, indicators of the ocular environment sensed by the sensors 130, such as at least one of the left sensor 130A, the right sensor 130B, or the redundant sensor 732. In one example, the control circuitry 140 can include a left control circuit including a left display capable of processing and displaying at least one of the indicators of the left sensor 130A or the indicators of the redundant sensor 732, and a right control circuit including a right display capable of processing and displaying at least one of the indicators of the right sensor 130B or the indicators of the redundant sensor 732.
[0185] 7 illustrates a schematic diagram of an example apparatus 600 that can include a sensor 130, such as a redundant sensor 732. The redundant sensor 732 can be in communication with a cavity 112, such as in communication with at least one of the left cavity 112A, the right cavity 112B, the left sensor 130A, or the right sensor 130B.
[0186] The redundant sensor 732 can be configured to sense an indicator of an ocular environment, such as at least one of an indicator of a left ocular environment in the left cavity 112A, an indicator of a right ocular environment in the right cavity 112B, or an indicator of a relationship between the indicator of the left ocular environment and the indicator of the right ocular environment. In one example, the redundant sensor 732 can be configured to verify or otherwise confirm proper operation of a sensor 130, such as at least one of the left sensor 130A or the right sensor 130B, that is monitored by the redundant sensor 732.
[0187] The redundant sensor 732 may include a differential sensor, such as a differential sensor including a left differential sensor in communication with the left cavity and a right differential sensor in communication with the right cavity, that detects at least one of an indicator of the left eye environment, an indicator of the right eye environment, or an indicator of a relationship between the indicator of the left eye environment and the indicator of the right eye environment. In one example, the differential sensor may detect a difference between an indicator of the left eye environment, such as an indicator of pressure in the left cavity 112A, and an indicator of the right eye environment, such as an indicator of pressure in the right cavity 112B.
[0188] The left differential sensor may include at least one of a left differential flow sensor to sense an indication of fluid flow rate in the left cavity 112A, a left differential humidity sensor to sense an indication of humidity in the left cavity 112A, a left temperature sensor to sense an indication of temperature in the left cavity 112A, a left differential pressure sensor to sense an indication of pressure in the left cavity 112A, or a left differential composition sensor to sense an indication of working fluid composition such as working fluid component concentrations in the left cavity 112A. The left differential sensor may include a left differential signal sensor in communication with a sensor 130, such as at least one of left sensor 130A or right sensor 130B, that receives an indication of the ocular environment sensed by sensor 130, such as an electrical signal representative of the indication of the ocular environment sensed by sensor 130.
[0189] The right differential sensor may include at least one of a right differential flow sensor to sense an indication of fluid flow rate in the right cavity 112B, a right differential humidity sensor to sense an indication of humidity in the right cavity 112B, a right differential temperature sensor to sense an indication of temperature in the right cavity 112B, a right differential pressure sensor to sense an indication of pressure in the right cavity 112B, or a right differential composition sensor to sense an indication of working fluid composition such as working fluid component concentrations in the right cavity 112B. The right differential sensor may include a right differential signal sensor in communication with a sensor 130, such as at least one of the left sensor 130A or the right sensor 130B, that receives an indication of the ocular environment sensed by the sensor 130, such as an electrical signal representative of the indication of the ocular environment sensed by the sensor 130.
[0190] 8 illustrates an example of a device 800 that can independently control a left ocular environment on a patient's left eye and a right ocular environment on a patient's right eye, such as with a single pressure source. The device 800 can include at least one of a cavity valve 890 or a cavity reservoir 892.
[0191] The apparatus 800 can include a cavity valve 890, such as a cavity valve 890 in communication with the cavity 112. The cavity valve 890 can be coupled to, or in communication with, at least one of the sensor 130, the control circuit 140, or the pressure source 150. In one example, the cavity valve 890 can include at least one of a left control valve 890A in communication with the left cavity 112A, or a right control valve 890B in communication with the right cavity 112B.
[0192] Cavity valves 890 can control the actuating fluid pressure in cavity 112, such as to achieve a target cavity pressure in cavity 112. With reference to FIGURE 8, left control valve 890A can control the actuating fluid pressure in cavity 112A, and right control valve 890B can control the actuating fluid pressure in cavity 112B.
[0193] Cavity valve 890 may include a passive cavity valve, such as passive cavity check valve 189 as previously described in this application. Cavity valve 890 may include a single passive cavity check valve 189, such as to maintain pressure in cavity 112 in the absence of continuous operation of pressure source 850. The lack of continuous operation of pressure source 850 may include many advantages, such as increasing the battery life of battery-powered pressure source 850.
[0194] The passive cavity check valve 189 can include a positive pressure cavity check valve. In one example, the pressure source 850 can be activated, such as by flowing a working fluid from the pressure source 850 through the positive pressure cavity check valve into the cavity 112, to provide a positive gauge pressure in the cavity 112. If the pressure source 850 is de-energized, such as when the pressure source 850 is turned off for a period of time, the positive pressure cavity check valve can close, such as to maintain the positive gauge pressure in the cavity 112. A sensor 130, such as in communication with at least one of the control circuit 840 or the pressure source 850, can sense the pressure in the cavity 112 and re-activate the pressure source 850, such as when the positive gauge pressure in the cavity 112 can drop below a threshold pressure level that includes a target positive cavity pressure level.
[0195] The passive cavity check valve 189 can include a negative pressure cavity check valve. In one example, the pressure source 850 can be activated to provide a negative gauge pressure in the cavity 112, such as by drawing hydraulic fluid from the cavity 112 through the negative pressure cavity check valve to the pressure source 850. If the pressure source 850 is de-energized, such as when the pressure source 850 is turned off for a period of time, the negative pressure cavity check valve can close, such as to maintain the negative gauge pressure in the cavity 112. A sensor 130, such as in communication with at least one of the control circuit 840 or the pressure source 850, can sense the pressure in the cavity 112 and re-activate the pressure source 850, such as when the negative gauge pressure in the cavity 112 can rise above a threshold pressure level that includes a target negative cavity pressure level.
[0196] The cavity valve 890 may include a combination of one or more passive cavity check valves 189, such as a passive combination cavity valve, that achieves a target cavity pressure range in the cavity 112. In one example, the cavity valve 890 may include at least one of a left passive combination cavity valve 890A or a right passive combination cavity valve 890B. The target cavity pressure range may be defined by an upper target cavity pressure level and a lower target cavity pressure level, such that the upper target cavity pressure level may be greater than the lower target cavity pressure level. In one example, the passive combination cavity valve may include a first passive cavity check valve having a first cracking pressure selected as the upper target cavity pressure level and a second passive cavity check valve having a second cracking pressure selected as the lower target cavity pressure level.
[0197] The passive combination cavity valve can be used as a safety device, such as to prevent damage to a patient's eye from excessive positive or negative applied pressure, including excessive pressure resulting from improper or unexpected operation of pressure source 850. In one example, a positive gauge pressure can be applied to cavity 112 in communication with the passive combination cavity valve acting as a safety device, such as having a first cracking pressure selected to be greater than a target positive cavity pressure level, including 10%, 20%, 30%, 40% or 50% greater than the target positive cavity pressure level, and a second cracking pressure selected at approximately 0 mmHg gauge pressure. In this configuration, device 800 can protect against excessive positive pressure from the first cracking pressure and excessive negative pressure from the second cracking pressure. In one example, a negative gauge pressure can be applied to cavity 112 in communication with a passive combination cavity valve acting as a safety device having a first cracking pressure selected to be less than a negative target cavity pressure level, including 10%, 20%, 30%, 40% or 50% less than the negative target cavity pressure level, and a second cracking pressure selected at about 0 mmHg gauge pressure. In this configuration, device 800 can protect against excessive negative pressure due to the first cracking pressure and excessive positive pressure due to the second cracking pressure.
[0198] A passive combination cavity valve can be used as a metering device to vary the pressure in cavity 112 based on the actuating fluid flow rate from pressure source 850 and an orifice area of cavity valve 890. In one example, a passive combination cavity valve can be specified to effect pressure in cavity 112 based on the volume-pressure characteristics of pressure source 850, including a pQ curve, or the like.
[0199] The cavity valve 890 can include an active cavity valve. In one example, the cavity valve 890 can include at least one of a left control valve 890A or a right control valve 890B. The active cavity valve can include a flow metering portion, such as a valve component that controls the flow rate through the active cavity valve, and an actuation portion, such as an actuator component that adjusts the flow metering portion. In one example, the active cavity valve can include at least one of a servo valve or a proportional valve, such as a servo valve or a proportional valve configured for use with at least one of a hydraulic actuating fluid or a pneumatic actuating fluid.
[0200] The active cavity valve can be adjusted to control pressure within cavity 112, such as a target cavity pressure, such as to control fluid flow between cavity 112 and the ambient environment. In one example, the active cavity valve can be adjusted to allow at least one of fluid flow from cavity 112 to the ambient environment when the cavity pressure is higher than the ambient environment, or fluid flow from the ambient environment into cavity 112 when the cavity pressure is lower than the ambient environment.
[0201] The active cavity valve can be configured to adjust the pressure in the cavity 112, such as from a first cavity pressure level to a second cavity pressure level different from the first cavity pressure level. The active cavity valve can adjust the pressure in the cavity 112 based on a sensed indicator, such as a sensed indicator received and processed by the control circuit 140. In one example, the left active cavity valve can be configured to adjust the indicator of the left cavity pressure based on at least one of an indicator received from a left biosensor, such as at least one of an indicator of a left IOP level, an indicator of a CSFP level, an indicator of a relationship between the left IOP and the CSFP, such as an indicator of a left TPD, or an indicator of cardiac activity, such as at least one of a systemic blood pressure or a heart rate. In one example, the right active cavity valve can be configured to adjust the indicator of the right cavity pressure based on at least one of indicators received from the right biosensor, such as at least one of an indicator of a right IOP level, an indicator of a CSFP level, an indicator of a relationship between right IOP and CSFP, such as an indicator of a right TPD, or an indicator of cardiac activity, such as at least one of a systemic blood pressure or a heart rate.
[0202] In one example, the control circuit 840 can control the cavity pressure in the left cavity 112A, such as by adjusting at least one of the pressure source 850 or the left control valve 890A to achieve a target cavity pressure in the left cavity 112A. For example, the left control circuit 140A can include a control mechanism, such as a feedback control mechanism, based on an indication from a received physiological parameter from the left sensor 130A, such as an indication of an IOP level in the left eye sensed by the left biosensor, and can be configured to process the received physiological parameter, such as to adjust at least one of the pressure source 850 or the left control valve 890A to achieve a target cavity pressure level in the left cavity 112A based on the received physiological parameter, such as the received indication of the left IOP level.
[0203] In one example, the control circuit 840 can control the cavity pressure in the right cavity 112B, such as by adjusting at least one of the pressure source 850 or the right control valve 890B to achieve a target cavity pressure in the right cavity 112B. For example, the control circuit 840 can include a control mechanism, such as a feedback control mechanism, based on an indication from a received physiological parameter from the right sensor 130B, such as an indication of an IOP level in the right eye sensed by the right biosensor, and can be configured to process the received physiological parameter, such as to adjust at least one of the pressure source 850 or the right control valve 890B to achieve a target cavity pressure level in the right cavity 112B based on the received physiological parameter, such as the received indication of the right IOP level.
[0204] The apparatus 800 can include a cavity check valve 189 similar to the cavity check valve 189 previously described herein. In one example, the cavity check valve 189 can include at least one of a left cavity check valve 189A, such as a left passive cavity check valve, or a right cavity check valve 189B, such as a right passive cavity check valve.
[0205] The device 800 can include a cavity reservoir 892, such as a cavity reservoir 892 in communication with the cavity 112. The cavity reservoir 892 can include at least one of a left cavity reservoir 892A and a right cavity reservoir 892B.
[0206] The cavity reservoir 892 can serve to adjust a measure of system elastance in the device 800, such as to improve the device's ability to achieve a target cavity pressure. System elastance can be characterized by at least one of the ratio of the change in pressure for a given change in volume, such as E=ΔP / ΔV, or the inverse of the system compliance, such as C=1 / E=ΔV / ΔP. In one example, a measure of system elastance can be equivalent to a measure of component elastance, and a measure of system compliance can be equivalent to a measure of component compliance. A "high" elastance fluid system refers to a fluid system that may have rapid pressure changes as a function of volume change. In one example, an active cavity valve may be unable to achieve a target cavity pressure in a high elastance device 800, such as due to a slow feedback response that results in the target cavity pressure being exceeded. Adjusting the elastance, such as by decreasing system elastance or increasing system compliance, can improve control of device 800, such as by decreasing the rate of pressure change due to volume change to minimize feedback tracking error.
[0207] The cavity reservoir 892 can include an auxiliary volume, such as a volumetric space in communication with the cavity 112 that includes at least one of a fluid accumulator or an expansion chamber. In one example, the auxiliary volume can be defined as any additional volume of the cavity 112, such as any component in fluid communication with the cavity 112, beyond the minimum volume required to deliver pressure to the patient's eye.
[0208] The amount of auxiliary volume in cavity reservoir 892 can be selected, such as to adjust the system elastance to change system delays and errors when pressurizing device 800. The auxiliary volume can be adjusted from a first auxiliary volume level to a second auxiliary volume. In one example, the second auxiliary volume level can be less than the first auxiliary volume level, such as to increase the system elastance. When increasing the system elastance, system delays for device 800 including pressure system delays can be reduced. In one example, the second auxiliary volume level can be greater than the first auxiliary volume level, such as to decrease the system elastance. When decreasing the system elastance, system delays for device 800 including pressure system delays can be increased.
[0209] Cavity reservoir 892 can include a highly compliant portion of device 800, such as a highly compliant portion of device 800 in fluid communication with cavity 112. A highly compliant portion can include a portion of device 800 in fluid communication with cavity 112, such as a portion of device 800 that demonstrates a higher rate of variability in component compliance than the lowest compliance component of cavity 112 or any component in fluid communication with cavity 112. The rate of variability in component compliance can range from about 1% to about 25%, about 25% to about 50%, about 50% to about 75%, or about 75% to about 100% as compared to the lowest compliance component of the system.
[0210] The highly compliant portion may include an elastic portion, such as the portion of device 800 in communication with cavity 112 that demonstrates a higher rate of variation in component compliance than the lowest compliant component of the system. In one example, the elastic portion may include a membrane, such as a flexible diaphragm as previously described herein.
[0211] The device 800 may include a system control circuit 840 similar to the control circuit 140 including the left control circuit 140A and the right control circuit 140B as previously described herein. The control circuit 840 may be configured to include a left system control circuit, such as a left system control circuit configured to receive an indication of the left ocular environment, such as from a left sensor 130A including a left biosensor, and adjust the pressure in the left cavity toward a left target IOP via a left control valve 890A based on at least one of the received indications of the left ocular environment, such as a received indication of the left IOP. The control circuit 140 may be configured to include a right system control circuit, such as a right system control circuit configured to receive an indication of the right ocular environment, such as from a right sensor 130A including a right biosensor, and adjust the pressure in the right cavity toward a right target IOP via a right control valve 890B based on at least one of the received indications of the right ocular environment, such as a received indication of the right IOP.
[0212] The left control circuit can be configured to adjust the left pressure in the left cavity 112A via the left active valve to equalize an indication of a left transcriboid plate pressure difference (TPD) associated with the left eye. The right control circuit can be configured to adjust the right pressure in the right cavity via the right active valve to equalize an indication of a right transcriboid plate pressure difference (TPD) associated with the right eye. In one example, equalizing an indication of TPD can include lowering the indication of TPD from a first TPD level to a second lower TPD level, such as at least one of a first left TPD level to a second lower left TPD level or a first right TPD level to a second lower right TPD level.
[0213] The left control circuit can be configured to adjust the left pressure in the left cavity by the left active valve sufficient to improve the indicator of axonal transport in the left optic nerve of the left eye, and the right control circuit can be configured to adjust the right pressure in the right cavity by the right active valve sufficient to improve the indicator of axonal transport in the right optic nerve of the right eye. In one example, improving the indicator of axonal transport can include adjusting the rate of axonal transport, e.g., increasing the rate of axonal transport from a first axonal transport level to a second axonal transport level, where the second axonal transport level can be higher than the first axonal transport level. In one example, improving the indicator of axonal transport can include adjusting the rate of axonal transport, e.g., decreasing the rate of axonal transport from a first axonal transport level to a second axonal transport level, where the second axonal transport level can be lower than the first axonal transport level.
[0214] The apparatus 800 can include a pressure source 850 similar to pressure source 150 as previously described herein. The pressure source 850 can be configured to apply a non-atmospheric pressure to the apparatus 800, such as to at least one of the left cavity 112A or the right cavity 112B. In one example, the pressure source 850 can be configured to pressurize or otherwise apply a non-atmospheric pressure to both the left cavity 112A and the right cavity 112B, such as to the left cavity 112A and the right cavity 112B simultaneously.
[0215] FIG. 9 shows a schematic diagram of an example device 900 capable of controlling an ocular environment on a patient's eye, such as at least one of a left ocular environment on a patient's left eye or a right ocular environment on a patient's right eye, with at least one of a main pressure source, a left pressure source, or a right pressure source.
[0216] The apparatus 900 can include a main pressure source 950, such as a pressure source similar to pressure source 150, in communication with a left pressure source 950A, such as a pressure source similar to left pressure source 150A, and a right pressure source 950B, such as a pressure source similar to right pressure source 150. The main pressure source 950 can draw working fluid from the surrounding environment, such as at port 951.
[0217] The apparatus 900 can include a manifold 975 that directs a flow of working fluid from a pressure source, such as at least one of a main pressure source 950, a left pressure source 950A, or a right pressure source 950B, to at least one of a left cavity 112A of the left cover 110A or a right cavity 112B of the right cover 110B. The manifold 975 can include a left column 977A with an inlet port 979A and an outlet port 981A, a right column 977B with an inlet port 979B and an outlet port 981B, and a center column 977C in communication with the left column 977A and the right column 977B. The manifold 975 may include control valves, such as electrically operated control valves including servo valves or proportional valves, including a left control valve 983A located adjacent to the left inlet port 979A to control the left working fluid flow into the left column 977A, a right control valve 983 located adjacent to the right inlet port 979B to control the right working fluid flow into the right column 977B, and a central control valve 983C in communication with the central column 977C to control the left and right working fluid flows between the left column 977A and the right column 977B.
[0218] The device 900 can control indicators of the ocular environment on the patient's left eye and the patient's right eye, for example, control of an indicator of left pressure in the left cavity 112A can be independent of an indicator of right pressure in the right cavity 112B, which can be independent of an indicator of left pressure in the left cavity 112B. In one example, the left control valve 983A and the right control valve 983B can be in an open state, such as to maximize volumetric flow through the left control valve 983A and the right control valve 983B, and the central control valve 983C can be in a closed state, such as to prevent volumetric flow through the central control valve 983C to isolate the left cavity 112A from the right cavity 112B, and similarly to isolate the right cavity 112B from the left cavity 112A. The primary pressure source 950 can be operated to generate a primary volumetric fluid flow in the device 900, such as to provide approximately equal primary volumetric flows in the left column 977A and the right column 977B. The primary pressure source 950 can be operated, such as to generate at least one of a positive gauge pressure or a negative gauge pressure in the left cavity 112A and the right cavity 112B.
[0219] Each of the left cover 110A and the right cover 110B can include a seal 119A, 119B to control fluid flow into and out of the cavities 112A, 112B. In one example, the seals 119A, 119B can control ambient air from entering the left and right cavities 112A, 112B, such as when a negative gauge pressure is applied to the left and right cavities 112A, 112B. In one example, the seals 119A, 119B can control working fluid from leaving the left and right cavities 112A, 112B, such as when a positive gauge pressure is applied to the left and right cavities 112A, 112B. The seal permeability can be controlled, such as from about 0% permeability (e.g., sealed) to about 100% permeability. In one example, the seal permeability can be controlled to a range, such as at least one of a range of about 0% permeability to about 25% permeability, a range of about 25% permeability to about 50% permeability, a range of about 50% permeability to about 75% permeability, or a range of about 75% permeability to about 100% permeability.
[0220] Seal permeability can be affected by tailoring the characteristics of the cover-patient contacting surface, e.g., the sealing surface that contacts the patient. A smooth sealing surface, such as a sealing surface that is in full contact with the patient, can form a continuous sealing surface around the patient's eye, such as providing a seal between the cover 110A, 110B and the patient. A non-smooth surface, such as a sealing surface that is not in full contact with the patient, can form a semi-continuous sealing surface around the patient's eye, such as providing a semi-permeable seal between the cover 110A, 110B and the patient. Non-smooth surfaces can include surfaces formed by materials with non-smooth surface finishes, including synthetic leather and elastomers with surface features formed therein, e.g., elastomers with at least one or more molded protrusions or molded depressions formed in the surface of the elastomer that inhibit the formation of a continuous sealing surface around the patient's eye.
[0221] Seal permeability can be affected by properties of the seal material, such as at least one of the porosity of the seal material, the size of the pores in the seal material, or the distribution of pore sizes in the seal material. In one example, the seal material can be formed with a specified total porosity, such as a range from about 0% porosity to about 100% porosity.
[0222] The ocular environment within the cavities 112A, 112B can be affected by features of the covers 110A, 110B, for example, the cover features can affect changes in the ocular environment similar to the effects of seal permeability. In one example, the cover features can include vents, such as one or more vents, that can extend from the outer surface 187 of the cover 110 to the inner surface 188 of the cover 110 to communicate the cavities 112 with the surrounding environment.
[0223] The adjustment of the ocular environment can be affected by characteristics of the vents, such as the vent surface area, including the total vent surface area, or the number of vents in the covers 110A, 110B. The vent surface area can affect the rate of fluid exchange between the cavity 112 and the surrounding environment, where for example the rate of fluid exchange can be determined by the surface area of the vents. The number of vents can affect the rate of fluid exchange, where for example the number of vents can affect the total vent surface area, where for example the rate of fluid exchange between the cavity 112 and the surrounding environment can be determined by the total surface area of the vents.
[0224] The pressure in the left and right cavities 112A, 112B can be varied, such as by adjusting the resistance offered to the primary volumetric fluid flow in the device 900. In one example, the open state of at least one of the left and right control valves 983A, 983B can be adjusted, such as from about 0% open to 100% open, to offer a resistance to the primary volumetric fluid flow, thereby adjusting the primary volumetric fluid flow in the left and right columns 977A, 977B. As a result, the gauge pressure in the left and right cavities 112A, 112B can be varied depending on the opening area offered by the left and right control valves 983A, 983B.
[0225] The pressure in the left cavity 112A and the right cavity 112B can be altered, such as by varying the total volumetric fluid flow in the device 900. In one example, the left pressure source 950A and the right pressure source 950B can be actuated to generate a left volumetric fluid flow resulting from the left pressure source 950A and a right volumetric fluid flow resulting from the right pressure source 950B. The left pressure source 950A and the right pressure source 950B can be actuated independently, e.g., the left volumetric flow resulting from the left pressure source 950A can be different from the right volumetric flow resulting from the right pressure source 950B. In adjusting the amount of energy applied to each of the left pressure source 950A and the right pressure source 950B, the independent left and right volumetric flows can allow for independent control of an index of left pressure in the left cavity 112A and an index of right pressure in the right cavity 112B.
[0226] Similarly, the device 900 can control an indication of the ocular environment on the patient's left eye and the patient's right eye, for example, control of an indication of left pressure in the left cavity 112A can depend on an indication of right pressure in the right cavity 112B, which can depend on an indication of left pressure in the left cavity. In one example, the central control valve 983C can be opened, such as from about 0% open to about 100% open, to communicate the left cavity 112A with the right cavity 112B and communicate the right cavity 112B with the left cavity 112A. In adjusting the amount of energy applied to each of the left pressure source 950A and the right pressure source 950B, the independent left and right volumetric flows can be mixed through a central control valve 983C, e.g., the left pressure in the left cavity 112A can depend on the right pressure source 950B and the right pressure in the right cavity 112B can depend on the left pressure source 950A. In one example, the left control valve 983A and the right control valve 983B can be opened, such as from about 0% open to about 100% open, to throttle at least one of the left volumetric flow due to the left pressure source 950A or the right volumetric flow due to the right pressure source 950B, e.g., the left pressure in the left cavity 112A can depend on the right pressure source 950B and the right pressure in the right cavity 112B can depend on the left pressure source 950A.
[0227] 10 shows a schematic diagram of a second example device 1000 that can control an ocular environment on a patient's eye, such as at least one of a left ocular environment on a patient's left eye or a right ocular environment on a patient's right eye, with a one-way valve in communication with a primary pressure source 950. The device 1000 can be similar to the device 900 and can include a one-way valve 1091, such as a valve that can allow fluid flow in a forward direction but prevent fluid flow in a reverse direction. The one-way valve 1091 can be located in communication with the primary pressure source 950, the left pressure source 950A, and the right pressure source 950B, such as between the primary pressure source 950 and the left pressure source 950A and the right pressure source 950B.
[0228] The one-way valve 1091 may be oriented in a forward direction toward the left and right cavities 112A, 112B. When the main pressure source 950 is activated (e.g., the pressure source 950 is turned "on"), the one-way valve 1091 may be opened to allow flow from the main pressure source 950 into the left and right cavities 112A, 112B, such as to generate a positive gauge pressure in the cavities 112A, 112B. When the power to the main pressure source 950 is removed (e.g., the pressure source 950 is turned "off"), the one-way valve 1091 may be closed, such as to maintain a positive gauge pressure in the left and right cavities 112A, 112B. By activating the left pressure source 950A and the right pressure source 950B, the gauge pressure in the left cavity 112A and the right cavity 112B can be adjusted, e.g., adjusted to increase or decrease the gauge pressure, to generate volumetric flow into the device 900 (e.g., the gauge pressure in the cavities can increase) or to generate volumetric flow out of the device 900 (e.g., the gauge pressure in the cavities can decrease).
[0229] In one example, the left positive gauge pressure in the left cavity 112A and the right positive gauge pressure in the right cavity 112B can be independently adjusted, such as by closing the control valves 983A, 983B, and 983C, such as by generating positive gauge pressure with the main pressure source 950 and maintaining and isolating the positive gauge pressure in the left cavity 112A and the right cavity 112B. The left pressure source 950A and the right pressure source 950B can be independently operated to adjust the gauge pressure in the left cavity 112A and the right cavity 112B, such as by increasing or decreasing the positive gauge pressure in the left cavity 112A independently from the right cavity 112B.
[0230] The one-way valve 1091 can be oriented in a forward direction toward the main pressure source 950. When the main pressure source 950 is activated (e.g., pressure source 950 is turned "on"), the one-way valve 1091 can be opened to allow flow from the left and right cavities 112A, 112B to the main pressure source 950, such as to generate negative gauge pressure in the cavities 112A, 112B. When power to the main pressure source 950 is removed (e.g., pressure source 950 is turned "off"), the one-way valve 1091 can be closed, such as to maintain negative gauge pressure in the left and right cavities 112A, 112B.
[0231] In one example, the left pressure in the left cavity 112A and the right pressure in the right cavity 112B can be independently adjusted, such as by closing the control valves 983A, 983B, and 983C, such as by generating a negative gauge pressure with the main pressure source 950 and maintaining and isolating the negative gauge pressure in the left cavity 112A and the right cavity 112B. The left pressure source 950A and the right pressure source 950B can be independently operated to adjust the gauge pressure in the left cavity 112A and the right cavity 112B, such as by increasing or decreasing the negative gauge pressure in the left cavity 112A independently from the right cavity 112B.
[0232] 11 shows a schematic diagram of a third example device 1100 that can control an ocular environment on a patient's eye, such as at least one of a left ocular environment on a patient's left eye or a right ocular environment on a patient's right eye, via a one-way valve 1091 in communication with a main pressure source and at least one of a left control valve 890A or a right control valve 890B. Device 1100 can be similar to device 1000 and can include a cavity valve 890, such as cavity valve 890 described herein above, including a left control valve 890A and a right control valve 890B.
[0233] The left control valve 890A can be in communication with the left cavity 112A, such as by being attached to the manifold 975 at a left port 984A. In one example, the left port 984A can be in communication with the column 977A, such as by having the left port 984A in communication with the left cavity 112A. The right control valve 890B can be in communication with the right cavity 112A, such as by being attached to the manifold 975 at a right port 984B. In one example, the right port 984B can be in communication with the column 977B, such as by having the right port 984B in communication with the right cavity 112B.
[0234] A device, such as at least one of devices 100, 600, 800, 900, 1000, or 1100, may be used to treat, inhibit, or prevent an eye disease in a patient. A process, such as a diagnostic or treatment regimen, may be implemented on a patient, such as a patient involved with an eye disease or the potential presence of an eye disease. In one example, a patient may be admitted by a medical professional, e.g., a patient may initiate contact with a medical professional to undergo at least one of screening, diagnosis, or treatment of an eye disease. In one example, a patient may be selected by a medical professional, e.g., a patient may be contacted or otherwise invited by a medical professional to undergo at least one of screening, diagnosis, or treatment of an eye disease. Selection by a medical professional may include selection based on screening criteria, such as criteria that identify "at risk" patients from an overall population for examination by a medical professional. Screening criteria may include patient screening criteria (or criteria specific to an individual patient), such as patient physiological parameters including age, weight, stress level, or genetic markers. Screening criteria can include environmental screening criteria (or criteria specific to the patient's living environment), such as the patient's place of residence, the patient's occupation, or potential exposure to substances identified in eye disease.
[0235] An eye disorder can be manifested as symptoms, such as the patient's symptoms of having an eye disorder. Symptoms can include patient discomfort, such as pain or other visual complaints, including blurred vision, or the physiological condition of the patient's eye, such as abnormal indices of IOP, CSFP, or cup-disc diameter ratio.
[0236] FIG. 12 illustrates an example method 1200 of using an apparatus, such as apparatus 100, to receive an indication and adjust a pressure source based on the received indication. The device 100 may include a left cover sized and shaped to fit over a patient's left eye to define a left cavity 112A between the left cover 110A and the front of the left eye, a left pressure source 150A in communication with the left cavity 112A and configured to adjust the fluid pressure in the left cavity 112A, a right cover 110B sized and shaped to fit over a patient's right eye to define a right cavity 112B between the right cover 110B and the front of the right eye, and a right pressure source 150B in communication with the right cavity 112B and configured to adjust the fluid pressure in the right cavity 112B, where the left pressure source 150A may be configured to adjust the fluid pressure in the left cavity 112A independently from the right pressure source 150B, and the right pressure source 150B may be configured to adjust the fluid pressure in the right cavity 112B independently from the left pressure source 150A.
[0237] At 1202, the device 100, e.g., at least one of the left pressure source 150A and the right pressure source 150B, can receive an indication of an ocular environment, such as a left ocular environment in the left cavity 112A sensed by the left sensor 130A or a right ocular environment in the right cavity 112B sensed by the right sensor 130B, an indication of IOP, such as a left intraocular pressure (IOP) in the patient's left eye sensed by the left sensor 130A or a right IOP in the patient's right eye sensed by the right sensor 130B, or an indication of cerebrospinal fluid pressure (CSFP) in the patient sensed by the left sensor 130A or the right sensor 130B. In one example, the left pressure source 150A can include a left control circuit 140A to receive the sensed left indication, and the right pressure source 150B can include a right control circuit 140B to receive the sensed right indication.
[0238] At 1204, at least one of the left pressure source 150A or the right pressure source 150B may be adjusted based on at least one of the received indicators, etc. In one example, the left pressure source 150A may be adjusted to generate a left non-atmospheric pressure in the left cavity 112A based on one of the received left indicators, and the right pressure source 150B may be adjusted to generate a right non-atmospheric pressure in the right cavity 112B based on at least one of the received right indicators.
[0239] In one example, the left pressure source 150A can receive an indication of the left ocular environment, such as an indication of left pressure in the left cavity 112A, and the left pressure source 150A can be adjusted based on the received indication of left pressure in the left cavity 112A, etc. The right pressure source 150B can receive an indication of the right ocular environment, such as an indication of right pressure in the right cavity 112A, and the right pressure source 150B can be adjusted based on the received indication of right pressure in the right cavity 112B, etc.
[0240] In one example, left pressure source 150A can receive an indication of left IOP from the patient's left eye via sensor 130A, such as a left IOP sensor, and left pressure source 150A can be adjusted based on the received indication of left IOP in the patient's left eye, etc. Right pressure source 150B can receive an indication of right IOP from the patient's right eye via sensor 130B, such as a right IOP sensor, and right pressure source 150B can be adjusted based on the received indication of right IOP in the patient's right eye, etc.
[0241] In one example, the left pressure source 150A can receive an indication of the left ocular environment, such as an indication of the left pressure in the left cavity 112A and an indication of the left IOP from the patient's left eye. The left pressure source 150A can then be adjusted based on the received indication of the left pressure in the left cavity 112A and the received indication of the left IOP in the left eye, etc. The right pressure source 150B can receive an indication of the right ocular environment, such as an indication of the right pressure in the right cavity 112A, and the right pressure source 150B can then be adjusted based on the received indication of the right pressure in the right cavity 112B, etc. The right pressure source 150B can receive an indication of the right ocular environment, such as an indication of the right pressure in the right cavity 112B and an indication of the right IOP from the patient's right eye. The right pressure source 150B can then be adjusted based on the received indication of the right pressure in the right cavity 112B and the received indication of the right IOP in the right eye, etc.
[0242] In one example, the left pressure source 150A can receive, such as by the left control circuit 140A, an index of left IOP and an index of CSFP. The left control circuit 140A can process the received indexes, such as to form an index of left transcriboid plate pressure difference (TPD). The left pressure source 150A can then adjust, such as to equalize the index of left TPD based on the received index of left TPD. The right pressure source 150B can receive, such as by the right control circuit 140B, an index of right IOP and an index of CSFP. The right control circuit 140B can process the received indexes, such as to form an index of right transcriboid plate pressure difference (TPD). The right pressure source 150B can then adjust, such as to equalize the index of right TPD based on the received index of right TPD.
[0243] Equalizing the index of TPD can include changing the index of TPD, such as decreasing the index of TPD from a first TPD level to a lower TPD level. 13 illustrates an example method 1300 for using an apparatus to sense an indication and adjust a valve based on the sensed indication. The apparatus may include at least one of apparatus 100, apparatus 600, apparatus 800, or a combination of the components of the apparatus described above. The apparatus may include a left sensor 130A in communication with the left cavity 112A including a left pressure sensor sensing an indication of a left pressure in the left cavity 112A, a right sensor 130B in communication with the right cavity 112B including a right pressure sensor sensing an indication of a right pressure in the right cavity 112B, and a system sensor including a redundant sensor, a system control circuit 640 in communication with the system sensor and configured to receive and process at least one of the indication of the left pressure or the indication of the right pressure, a left control valve 890A in communication with the left cavity 112A and in communication with the system control circuit 640, and a right control valve 890B in communication with the right cavity 112B and in communication with the system control circuit 640.
[0244] At 1302, the device can sense an indication pressure, such as an indication of left pressure and an indication of right pressure. The left cavity 112A and the right cavity 112B can be pressurized by a pressure source 850, such as to a positive or negative non-atmospheric pressure level. The device can sense an indication of the ocular environment, such as an indication of pressure by a system sensor. In one example, the device can sense an indication of left pressure in the left cavity 112A by a left pressure sensor and an indication of right pressure in the right cavity 112B by a right pressure sensor.
[0245] At 1304, the apparatus may adjust the valves based on the indications of the sensed pressures, such as an indication of a sensed left pressure and an indication of a sensed right pressure. A left valve, such as left control valve 890A in communication with left cavity 112A, may be adjusted based on an indication of the sensed left pressure in left cavity 112A, etc. In adjusting the left control valve 890A, the pressure in left cavity 112A may be changed, such as to achieve a target cavity pressure in left cavity 112A. A right valve, such as right control valve 890B in communication with right cavity 112B, may be adjusted based on an indication of the sensed right pressure in right cavity 112B, etc. In adjusting the right control valve 890B, the pressure in right cavity 112A may be changed, such as to achieve a target cavity pressure in right cavity 112B.
[0246] In one example, the left sensor 130A can include a left biosensor configured to sense at least one of an indication of a left intraocular pressure (IOP) in the left eye or an indication of a cerebrospinal fluid pressure (CSFP) in the patient in communication with the system control circuit 640. A left valve, such as the left control valve 890A in communication with the left cavity 112A, can be adjusted based on at least one of the indication of the sensed left pressure in the left cavity 112A, the indication of the sensed left IOP, or the indication of the sensed CSFP, etc. In adjusting the left control valve 890A, the pressure in the left cavity 112A can be adjusted to change the left pressure towards a left target IOP level, for example, the left pressure in the left cavity 112A can be adjusted to achieve a left IOP level including a left target IOP level in the left eye based on the received indication of the left IOP.
[0247] In one example, the right sensor 130B may include a right biosensor configured to sense at least one of an indication of right intraocular pressure (IOP) in the right eye or an indication of cerebrospinal fluid pressure (CSFP) in the patient in communication with the system control circuit 640. A right valve, such as the right control valve 890B in communication with the right cavity 112B, may be adjusted based on at least one of the indication of the right pressure in the sensed left cavity 112A, the indication of the sensed right IOP, or the indication of the sensed CSFP, etc. In adjusting the right control valve 890B, the pressure in the right cavity 112B may be adjusted to change the right pressure toward a right target IOP level, for example, the right pressure in the right cavity 112B may be adjusted to achieve a right IOP level including a right target IOP level in the right eye based on the received indication of right IOP.
[0248] In one example, adjusting the active left valve can include adjusting the active left valve to change the left pressure in the left cavity 112A, such as to equalize a measure of left transcriboid plate pressure difference (TPD) associated with the left eye. Adjusting the active right valve can include adjusting the active right valve to change the right pressure in the right cavity 112B, such as to equalize a measure of right transcriboid plate pressure difference (TPD) associated with the right eye. Equalizing a measure of TPD can include changing the measure of TPD, such as decreasing the measure of TPD from a first TPD level to a second, lower TPD level.
[0249] In one example, adjusting the active left valve can include adjusting the active left valve to vary the left pressure in the left cavity 112A, such as to achieve a left pressure sufficient to improve an index of axonal transport in the left optic nerve of the left eye, and adjusting the active right valve can include adjusting the active right valve to vary the right pressure in the right cavity 112B, such as to achieve a right pressure sufficient to improve an index of axonal transport in the right optic nerve of the right eye.
[0250] 14 illustrates an example method 1400 for using a device to sense indicators and limit pressure applied to a cavity. The device may include at least one of device 100, device 600, device 800, or a combination of components of the devices described above. The device may include a pressure source 150 in communication with a left cavity 112A located over a left eye of a patient and a right cavity 112B located over a right eye of a patient, and system sensors including a left cavity sensor 130 for sensing an indicator of a left ocular environment in the left cavity, a right cavity sensor 130B for sensing an indicator of a right ocular environment in the right cavity, and a redundant sensor 732 for sensing a relationship between the indicator of the left ocular environment and the indicator of the right ocular environment.
[0251] At 1402, the device can sense an indication pressure, such as an indication of left pressure and an indication of right pressure. The left cavity 112A and the right cavity 112B can be pressurized by a pressure source 850, such as to a positive or negative non-atmospheric pressure level. The device can sense an indication of the ocular environment, such as an indication of pressure by a system sensor. In one example, the device can sense an indication of left pressure in the left cavity 112A by a left pressure sensor and an indication of right pressure in the right cavity 112B by a right pressure sensor.
[0252] At 1404, the device can limit pressure applied to the left cavity 112A and the right cavity 112B, etc. A valve 890, such as a passive valve, can be selected to limit the actuation fluid pressure in the cavity 112, such as based on characteristics of the valve 890, including a cracking pressure of the valve. Limiting the pressure applied to the left cavity 112A can include at least one of selecting a left control valve 890A, such as a passive left valve in communication with the left cavity 112A, or selecting a left cracking pressure associated with the left passive valve, such as to limit the left pressure applied to the left eye in the left cavity 112A. The left cracking pressure can be selected to include a left target pressure, such as a left target cavity pressure level. Limiting the pressure applied to the right cavity 112B can include at least one of selecting a right control valve 890B, such as a passive right valve in communication with the right cavity 112B, or selecting a right cracking pressure associated with the right passive valve, such as to limit the right pressure applied to the right eye in the right cavity 112B. The right cracking pressure can be selected to include a right target pressure, such as a right target cavity pressure level.
[0253] A valve 890, such as an active valve, in communication with the cavity 112 may be selected, such as to limit the hydraulic fluid pressure in the cavity 112. Limiting the pressure applied to the left cavity 112A may include opening an active left valve, such as based on an indication of a left pressure in the left cavity 112A sensed by a left sensor 130A including a left pressure sensor. The indication of the left pressure in the left cavity 112A may include an indication of a difference between an indication of the left pressure in the left cavity 112A and a left safe pressure level, such as at least one of a maximum pressure level or a minimum pressure level in the left cavity 112A. Limiting the pressure applied to the right cavity 112B may include opening an active right valve, such as based on an indication of a right pressure in the right cavity 112B sensed by a right sensor 130B including a right pressure sensor. The indication of the right pressure in the right cavity 112B may include an indication of a difference between the indication of the right pressure in the right cavity 112B and a right safe pressure level, such as at least one of a maximum pressure level or a minimum pressure level in the right cavity 112A.
[0254] The pressure source 150 can be adjusted, such as to limit the hydraulic fluid pressure in the cavity 112. Adjusting the operation of the pressure source 150 can include adjusting the pressure in the cavity 112, such as by adjusting an indication of the hydraulic fluid flow rate provided by the pressure source 150. The indication of the hydraulic fluid flow rate can include varying the operation of the pressure source 150, such as increasing or decreasing the speed of the pump to affect the hydraulic fluid flow rate of the pump. Limiting the pressure applied to the left cavity 112A can include adjusting the operation of the left pressure source 150A based on at least one of a left pressure in the left cavity 112A or a difference between an indication of the left pressure in the left cavity 112A and a left safety pressure level, etc. Limiting the pressure applied to the right cavity 112B can include adjusting the operation of the right pressure source 150B based on at least one of a right pressure in the right cavity 112B or a difference between an indication of the right pressure in the right cavity 112B and a right safety pressure level, etc.
[0255] Various notes and examples The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, certain embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples that use any combination or permutation of the illustrated or described elements (or one or more aspects thereof) with respect to a particular example (or one or more aspects thereof) shown or described herein, or with respect to other examples (or one or more aspects thereof).
[0256] In the event of a conflicting usage between this specification and any document incorporated herein by reference, the usage in this specification shall control. The terms "a" and "an" are used herein to include one or more, as is common in the patent literature, regardless of any other instances or usages of "at least one" or "one or more." The term "or" is used herein to refer to an exclusive or, and "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. The terms "including" and "in which" are used herein as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to those recited after such terms in a claim is still considered to be within the scope of that claim. Moreover, in the following claims, the terms "first," "second," "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects.
[0257] The method examples described herein may be implemented at least in part by a machine or computer. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform the method as described in the examples above. Such method implementations may include code, such as microcode, assembly language code, higher level language code, etc. Such code may include computer-readable instructions to perform various methods. The code may form part of a computer program product. Further, in one example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), etc.
[0258] FIG. 15 illustrates an example block diagram of an example computer 1500 that can be used as the control circuit 140. Methods can be implemented in the control circuit 140. The control circuit 140 can include a computer 1500 that can perform any one or more of the techniques or methods discussed herein. The machine 1500 can be a local or remote computer, or a processing node in an on-the-go (OTG) device, such as a smartphone, tablet, or wearable device. The machine 1500 can operate as a standalone device or can be connected (e.g., networked) to other machines. In an example, the machine can be directly coupled to or integrated with the device 100, such as any component of the device 100. When the processor 1502 is directly coupled to the device 100, some components of the machine 1500 can be omitted to provide a lightweight and flexible device (e.g., a display device, a UI navigation device, etc.). In a networked arrangement, the machine 1500 can operate in a server-client network environment in the capacity of a server machine, a client machine, or both. In one example, the machine 1500 can function as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. The machine 1500 can be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify operations to be performed by the machine. In one example, the machine 1500 can include purpose-designed circuitry, such as a printed circuit board, capable of performing the functions and methods disclosed throughout this specification.Additionally, although only a single machine is illustrated, the term "machine" may be construed to include any collection of machines that individually or together execute a set (or sets) of instructions that implement any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations, etc.
[0259] Examples such as those described herein may include or operate with logic or multiple components or mechanisms. A circuit may include a collection of circuits (e.g., simple circuits, gates, logic, etc.) implemented with tangible entities including hardware. The membership of a circuit may be flexible over time and variability of the underlying hardware. A circuit includes members that can perform specified operations, either alone or in combination, while operating. In one example, the hardware of a circuit may be invariably designed (e.g., hardwired) to perform a predetermined operation. In one example, the hardware of a circuit may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) that include computer-readable media (e.g., magnetically, electrically, movable arrangements of particles of invariable mass, etc.) that are physically altered to encode instructions for a predetermined operation. In connecting the physical components, the underlying electrical properties of the hardware components are altered, for example, from insulators to conductors or vice versa. The instructions enable the embedded hardware (e.g., an execution unit or a loading mechanism) to generate members of the hardware circuitry via variable connections to perform some portion of a predetermined operation when in operation. Thus, the computer-readable medium is communicatively coupled to other components of the circuitry when the device is in operation. In one example, any one of the physical components may be used in more than one member of more than one circuitry. For example, during operation, an execution unit may be used in a first circuit of a first circuitry at one time and reused by a second circuit of the first circuitry or by a third circuit of the second circuitry at a different time.
[0260] The machine (e.g., computer system) 1500 may include a hardware processor 1502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1504, and a static memory 1506, some or all of which may communicate with each other via an interlink (e.g., a bus) 1508. The machine 1500 may further include a display unit 1510, an alphanumeric input device 1512 (e.g., a keyboard), and a user interface (UI) navigation device 1514 (e.g., a mouse). In one example, the display unit 1510, the input device 1512, and the UI navigation device 1514 may be touch screen displays. The machine 1500 may further include a storage device (e.g., a drive unit) 1516, a signal generating device 1518 (e.g., a speaker), a network interface device 1520, and one or more sensors 1521, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensor. In one example, the sensors 1521, including, for example, the sensor 130, may include wearable assistive device-based sensors and environmental sensors, as described above. The machine 1500 may include an output controller 1528, such as a serial (e.g., Universal Serial Bus (USB)), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection, to communicate with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).
[0261] The storage device 1516 can include a machine-readable medium 1522 on which is stored one or more sets of data structures or instructions 1524 (e.g., software) that embody or are utilized by any one or more of the techniques or functions described herein. The instructions 1524 can reside, completely or at least partially, in the main memory 1504, in the static memory 1506, or in the hardware processor 1502 during their execution by the machine 1500. In one example, one or any combination of the hardware processor 1502, the main memory 1504, the static memory 1506, or the storage device 1516 can constitute a machine-readable medium.
[0262] Although the machine-readable medium 1522 is illustrated as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) configured to store one or more instructions 1524.
[0263] The term "machine-readable medium" can include any medium that can store, encode, or carry instructions executed by the machine 1500, cause the machine 1500 to perform any one or more of the techniques of this disclosure, or store, encode, or carry data structures used by or related to such instructions. Non-limiting machine-readable storage media can include solid-state memory, and optical and magnetic media. In one example, a massive machine-readable medium includes a machine-readable medium having a plurality of particles with an unchanging (e.g., stationary) mass. Thus, a massive machine-readable medium is not a transitory propagating signal. Certain examples of massive machine-readable media can include non-volatile memory such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks.
[0264] The instructions 1524 may further be transmitted or received over a communications network 1526 using a transmission medium via a network interface device 1520 utilizing any one of a number of transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communications networks include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile telephone networks (e.g., cellular networks), plain old telephone service (POTS) networks, wireless data networks (e.g., the Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, the IEEE 802.16 family of standards known as WiMax®), the IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In one example, the network interface device 1520 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to a communications network 1526. In one example, the network interface device 1520 may include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term "transmission medium" is intended to include any intangible medium capable of storing, encoding, or carrying instructions executed by the machine 1500, and includes digital or analog communications signals or other intangible media that facilitate communication of such software.
[0265] The above description is intended to be illustrative, not limiting. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used by those of ordinary skill in the art who have reviewed the above description. The Abstract is provided in accordance with 37 CFR 1.72(b) to enable the reader to quickly ascertain the nature of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Additionally, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that any unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the invention may lie in less than all features of a particular disclosed embodiment. Accordingly, it is contemplated that the following claims will be incorporated into the Detailed Description as an example or embodiment, with each claim standing on its own as a separate embodiment, and that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The technical ideas contained in the present disclosure are described below. (Appendix 1) 1. An apparatus comprising: a left cover sized and shaped to fit over the patient's left eye to define a left cavity between the left cover and the front of the patient's left eye; a left pressure source in communication with the left cavity and configured to adjust fluid pressure within the left cavity; a right cover sized and shaped to fit over the patient's right eye to define a right cavity between the right cover and the front of the patient's right eye; a right pressure source in communication with the right cavity and configured to regulate a fluid pressure within the right cavity; and a control circuit connected to at least one of the left pressure source and the right pressure source, the system control circuit configured such that the left pressure source can regulate the fluid pressure in the left cavity independent of the right pressure source and the right pressure source can regulate the fluid pressure in the right cavity independent of the left pressure source. (Appendix 2) a left cavity sensor in communication with the left cavity and configured to sense an indication of a left eye environment within the left cavity; a right cavity sensor in communication with the right cavity and configured to sense an indication of a right ocular environment within the right cavity; a redundant sensor configured to sense at least one of the indicator of the left eye environment, the indicator of the right eye environment, and an indicator of a relationship between the indicator of the left eye environment and the indicator of the right eye environment; 2. The apparatus of claim 1, comprising a system sensor including: (Appendix 3) the left cavity sensor includes a left pressure sensor sensing an indication of left pressure within the left cavity; the right cavity sensor includes a right pressure sensor sensing an indication of right pressure within the right cavity; 3. The apparatus of claim 2, wherein the redundant sensor includes a redundant sensor that senses an indicator of a relationship between the indicator of the left eye environment and the indicator of the right eye environment. (Appendix 4) 3. The apparatus of claim 2, wherein the redundant sensor includes a differential pressure sensor configured to sense a difference between an indication of left pressure in the left cavity by a left differential pressure sensor and an indication of right pressure in the right cavity by a right differential pressure sensor. (Appendix 5) 3. The apparatus of claim 2, wherein the redundant sensor includes a differential signal sensor configured to detect a difference between an indication of left pressure from the left cavity sensor by a left differential signal sensor and an indication of right pressure from the right cavity sensor by a right differential signal sensor. (Appendix 6) 3. The apparatus of claim 2, wherein the system control circuitry is configured to receive and process at least one of an indication of the left eye environment in the left cavity, an indication of the right eye environment in the right cavity, and an indication of a relationship between the left eye environment and the right eye environment. (Appendix 7) The system control circuit, a left control circuit coupled to the left pressure source and capable of receiving and processing at least one of an indication of the left ocular environment and an indication of a relationship between the left ocular environment and the right ocular environment; and a right control circuit in communication with the right pressure source and capable of receiving and processing at least one of an indication of the right ocular environment and an indication of a relationship between the left ocular environment and the right ocular environment. (Appendix 8) the left control circuit includes a left control circuit configured to adjust the left pressure source to generate a non-atmospheric pressure in the left cavity toward a left target cavity pressure in the left cavity; 8. The apparatus of claim 7, including a right control circuit configured to adjust the right pressure source to generate a non-atmospheric pressure in the right cavity toward a right target cavity pressure in the right cavity. (Appendix 9) a left biosensor in communication with the left control circuit and configured to sense at least one of an indication of left intraocular pressure (IOP) in the left eye and an indication of cerebrospinal fluid pressure (CSFP) in the patient; and a right biosensor in communication with the right control circuit and configured to sense at least one of an indication of right IOP in the right eye and an indication of CSFP in the patient. (Appendix 10) the left control circuit configured to receive the indication of left IOP and adjust the left pressure source to generate a non-atmospheric pressure toward a left target IOP level [G] based on the received indication of left IOP; 10. The apparatus of claim 9, further comprising a right control circuit configured to receive the indication of right IOP and adjust the right pressure source to generate a non-atmospheric pressure toward a right target IOP level [G] based on the received indication of right IOP. (Appendix 11) the left control circuit configured to generate a non-atmospheric pressure toward the left target IOP level includes a left target IOP level in the left eye ranging from about 10 mmHg to about 21 mmHg; 11. The device of claim 10, wherein the right control circuitry configured to generate a non-atmospheric pressure toward the right target IOP level includes a right target IOP level in the right eye ranging from about 10 mmHg to about 21 mmHg. (Appendix 12) the left control circuit configured to adjust the left pressure source to generate a non-atmospheric pressure in the left cavity to equalize an index of a left transcriboid pressure gradient (TLPG) associated with the left eye, wherein equalizing the index of the left TLPG includes reducing the index of the left TLPG from a first left TLPG level to a second left TLPG level, 10. The device of claim 9, wherein the right control circuit includes a right control circuit configured to adjust the right pressure source to generate a non-atmospheric pressure in the right cavity to equalize an index of a right TLPG associated with the right eye, and equalizing the index of the right TLPG includes reducing the index of the right TLPG from a first right TLPG level to a lower second right TLPG level. (Appendix 13) the left control circuit configured to adjust the left pressure source to generate a non-atmospheric pressure in the left cavity to enhance an indication of axonal transport in the left optic nerve of the left eye; the right control circuit configured to adjust the right pressure source to generate a non-atmospheric pressure in the right cavity to improve an indication of axonal transport in the right optic nerve of the right eye; 10. The apparatus of claim 9, wherein improving the indicator of axonal transport comprises increasing a rate of axonal transport from a first axonal transport level to a higher second axonal transport level. (Appendix 14) the left control circuit configured to regulate the left pressure source to generate a non-atmospheric pressure in the left cavity to treat, inhibit or prevent an ocular disease in the left eye; 10. The device of claim 9, further comprising a right control circuit configured to regulate the right pressure source to generate a non-atmospheric pressure in the right cavity to treat, inhibit or prevent an ocular disease of the right eye. (Appendix 15) 2. The apparatus of claim 1, comprising a left passive cavity check valve communicating with the left cavity and configured to limit left pressure in the left cavity to a left cracking pressure; and a right passive cavity check valve communicating with the right cavity and configured to limit right pressure in the right cavity to a right cracking pressure. (Appendix 16) 1. A method of using a device, the device comprising: a left cover sized and shaped to fit over a patient's left eye to define a left cavity between the left cover and a front of the patient's left eye; a left pressure source in communication with the left cavity and configured to regulate fluid pressure in the left cavity; a right cover sized and shaped to fit over a patient's right eye to define a right cavity between the right cover and a front of the patient's right eye; and a right pressure source in communication with the right cavity and configured to regulate fluid pressure in the right cavity, the left pressure source configured to regulate fluid pressure in the left cavity independently from the right pressure source and the right pressure source configured to regulate fluid pressure in the right cavity independently from the left pressure source. receiving, by the device, at least one of an indication of left ocular environment, an indication of right ocular environment, an indication of left intraocular pressure (IOP) in the left eye, an indication of right IOP in the right eye, and an indication of cerebrospinal fluid pressure (CSFP) in the patient; adjusting at least one of the left pressure source to generate a non-atmospheric pressure in the left cavity based on at least one of the received indicators, and the right pressure source to generate a non-atmospheric pressure in the right cavity based on at least one of the received indicators. (Appendix 17) receiving an indication includes receiving an indication of the left ocular environment including an indication of a left pressure source, and adjusting the pressure source includes adjusting the left pressure source based on the indication of the left cavity pressure; 17. The method of claim 16, wherein the step of receiving an indication includes receiving an indication of the right ocular environment including an indication of a right pressure source, and the step of adjusting the pressure source includes adjusting the right pressure source based on the indication of the right cavity pressure. (Appendix 18) receiving an indication includes receiving an indication of the left IOP, and adjusting the pressure source includes adjusting the left pressure source based on the indication of the left IOP; 17. The method of claim 16, wherein receiving an indication comprises receiving an indication of the right IOP, and adjusting the pressure source comprises adjusting the right pressure source based on the indication of the right IOP. (Appendix 19) receiving an indication includes receiving an indication of the left cavity pressure and the left IOP; and adjusting the pressure source includes adjusting the left pressure source based on the indication of the left cavity pressure and the left IOP; 17. The method of claim 16, wherein the step of receiving an indicator includes receiving an indicator of the right cavity pressure and right IOP, and the step of adjusting the pressure source includes adjusting the right pressure source based on the indicators of the right cavity pressure and right IOP. (Appendix 20) the step of receiving an indication includes receiving an indication of a left transcriboid pressure difference (TPD) associated with the left eye, and the step of adjusting the pressure source includes adjusting the left pressure source to equalize the indication of the left TPD; the step of receiving an indication includes receiving an indication of a right TPD associated with the right eye, and the step of adjusting the pressure source includes adjusting the right pressure source to equalize the indication of the right TPD; 17. The method of claim 16, wherein equalizing the indicator of TPD includes reducing the indicator of TPD from a first TPD level to a lower second TPD level. (Appendix 21) 1. An apparatus for adjusting fluid pressure applied to at least one of a left cavity located over a left eye of a patient and a right cavity located over a right eye of the patient to treat, inhibit or prevent an ocular disorder, the apparatus comprising: a differential sensor in communication with the left cavity and the right cavity and configured to sense at least one of an indication of a left eye environment in the left cavity, an indication of a right eye environment in the right cavity, and an indication of a relationship between the indication of the left eye environment and the indication of the right eye environment; and a control circuit in communication with the system sensor and configured to receive and process at least one of an indication of the left eye environment in the left cavity, an indication of the right eye environment in the right cavity, and an indication of a relationship between the indication of the left eye environment and the indication of the right eye environment. (Appendix 22) 22. The apparatus of claim 21, comprising at least one of a left cavity sensor coupled to the system control circuitry and configured to detect an indicator of a left eye environment in the left cavity, and a right cavity sensor coupled to the system control circuitry and configured to detect an indicator of the right eye environment in the right cavity. (Appendix 23) 22. The apparatus of claim 21, wherein the differential sensor includes a differential pressure sensor configured to sense a difference between an indication of left pressure in the left cavity sensed by a left differential pressure sensor and an indication of right pressure in the right cavity sensed by a right differential pressure sensor. (Appendix 24) 22. The apparatus of claim 21, wherein the differential sensor includes a differential signal sensor configured to detect a difference between an indication of left pressure from the left pressure sensor sensed by a left differential signal sensor and an indication of right pressure from the right pressure sensor sensed by a right differential signal sensor. (Appendix 25) 22. The apparatus of claim 21, comprising a pressure source in communication with at least one of the left and right cavities and configured to apply a non-atmospheric pressure to at least one of the left and right cavities. (Appendix 26) 26. The apparatus of claim 25, wherein the pressure source comprises a pressure source configured to apply a non-atmospheric pressure to the left cavity and the right cavity. (Appendix 27) a left cavity valve in communication with the left cavity and configured to adjust the index of the left pressure within the left cavity; 23. The apparatus of claim 22, further comprising: a right cavity valve in communication with the right cavity and configured to adjust the indication of the right pressure in the right cavity. (Appendix 28) 28. The apparatus of claim 27, wherein the left valve comprises at least one of a passive left valve and an active left valve, and the right valve comprises at least one of a passive right valve and an active right valve. (Appendix 29) 29. The apparatus of claim 28, wherein the left cavity valve includes an active left cavity valve configured to adjust the left pressure index based on at least one of the indicators received by the system control circuit, and the right cavity valve includes an active right cavity valve configured to adjust the right pressure index based on at least one of the indicators received by the system control circuit. (Appendix 30) a left biosensor in communication with the system control circuitry and configured to sense at least one of an indication of left intraocular pressure (IOP) in the left eye and an indication of cerebrospinal fluid pressure (CSFP) in the patient; a right biosensor in communication with the system control circuitry and configured to sense at least one of an indication of right IOP in the right eye and an indication of CSFP in the patient; 28. The apparatus of claim 27, wherein the left cavity valve includes an active left cavity valve configured to adjust the indication of left pressure based on at least one of the indications received from the left biosensor, and the right cavity valve includes an active right cavity valve configured to adjust the indication of right pressure based on at least one of the indications received from the right biosensor. (Appendix 31) the system control circuit includes a left control circuit configured to receive the indication of left IOP and adjust a left pressure in the left cavity toward a left target IOP level via the active left valve based on the received indication of left IOP; 31. The apparatus of claim 30, wherein the system control circuitry includes a right control circuit configured to receive the indication of right IOP and adjust right pressure in the right cavity toward a right target IOP level via the active right valve based on the received indication of right IOP. (Appendix 32) the system control circuit includes a left control circuit configured to adjust a left pressure in the left cavity by the left active valve to equalize a measure of a left transcriboid pressure difference (TPD) associated with the left eye, and equalizing the measure of the left TPD includes reducing the measure of the left TPD from a first left TPD level to a second left TPD level, which is lower; 31. The apparatus of claim 30, wherein the system control circuit includes a right control circuit configured to adjust the right pressure in the right cavity by the right active valve to equalize an index of a right TPD associated with the right eye, and equalizing the index of the right TPD includes reducing the index of the right TPD from a first right TPD level to a lower second right TPD level. (Appendix 33) the system control circuitry includes a left control circuit configured to adjust a left pressure in the left cavity by the left active valve sufficient to improve an indication of axonal transport in a left optic nerve of the left eye; the system control circuitry includes a right control circuit configured to adjust a right pressure in the right cavity by the active right valve sufficient to improve an indication of axonal transport in the right optic nerve of the right eye; 31. The apparatus of claim 30, wherein improving the indicator of axonal transport comprises increasing a rate of axonal transport from a first axonal transport level to a higher second axonal transport level. (Appendix 34) the system control circuitry includes a left control circuit configured to regulate a left pressure in the left cavity by the active left valve to treat, inhibit or prevent an ocular disease in the left eye; 31. The device of claim 30, wherein the system control circuitry includes a right control circuit configured to regulate a right pressure in the right cavity by the active right valve to treat, inhibit or prevent an ocular disease in the right eye. (Appendix 35) 22. The apparatus of claim 21, comprising a passive left valve in communication with the left cavity and configured to limit a left pressure in the left cavity to a left cracking pressure; and a passive right valve in communication with the right cavity and configured to limit a right pressure in the right cavity to a right cracking pressure. (Appendix 36) 10. A method of using an apparatus comprising: a system sensor including a left pressure sensor in communication with a left cavity and sensing an indication of a left pressure in the left cavity, a right pressure sensor in communication with a right cavity and sensing an indication of a right pressure in the right cavity, and a redundant sensor; a system control circuit in communication with the system sensor and configured to receive and process at least one of the indication of the left pressure and the indication of the right pressure; an active left valve in communication with the left cavity and in communication with the system control circuit; and an active right valve in communication with the right cavity and in communication with the system control circuit, sensing with the system sensors an indication of the left pressure in the left cavity and an indication of the right pressure in the right cavity; and adjusting at least one of the active left valve based on an indication of the sensed left pressure, and the active right valve based on an indication of the sensed right pressure. (Appendix 37) the device includes a left biosensor in communication with the system control circuitry and configured to sense at least one of an indication of left intraocular pressure (IOP) in the left eye and an indication of cerebrospinal fluid pressure (CSFP) in the patient; and a right biosensor in communication with the system control circuitry and configured to sense at least one of an indication of right IOP in the right eye and an indication of CSFP in the patient; 37. The method of claim 36, wherein adjusting at least one of the active left valve and the active right valve includes adjusting the active left valve based on at least one of the indicators received from the left biosensor, and at least one of the active right valve based on at least one of the indicators received from the right biosensor. (Appendix 38) 38. The method of claim 37, wherein adjusting at least one of the active left valve and the active right valve includes adjusting at least one of the active left valve to change a left pressure toward a left target IOP level based on the received indication of left IOP, and the active right valve to change a right pressure toward a right target IOP level based on the received indication of right IOP. (Appendix 39) adjusting the at least one of the active left valve and the active right valve includes adjusting the active left valve to equalize a measure of left transcriboid pressure difference (TPD) associated with the left eye and the active right valve to equalize a measure of right transcriboid pressure difference (TPD) associated with the right eye; 38. The method of claim 37, wherein equalizing the indicator of TPD includes reducing the indicator of TPD from a first TPD level to a lower second TPD level. (Appendix 40) adjusting the at least one of the active left valve and the active right valve includes adjusting the active left valve to achieve a left pressure in the left cavity sufficient to improve an indication of axonal transport in the left optic nerve of the left eye, and adjusting at least one of the active right valve to achieve a right pressure in the right cavity sufficient to improve an indication of axonal transport in the right optic nerve of the right eye; 38. The method of claim 37, wherein improving the indicator of axonal transport comprises increasing the rate of axonal transport from a first axonal transport level to a higher second axonal transport level. (Appendix 41) 1. A device for limiting fluid pressure levels applied to a patient's left and right eyes, comprising: a pressure source in communication with a left cavity overlying the left eye and a right cavity overlying the right eye and configured to adjust a measure of fluid pressure within the left cavity and the right cavity; and a differential sensor in communication with the left and right cavities and configured to sense at least one of an indication of a left eye environment in the left cavity, an indication of a right eye environment in the right cavity, and an indication of a relationship between the indication of the left eye environment and the indication of the right eye environment. (Appendix 42) 42. The apparatus of claim 41, comprising at least one of a left cavity sensor coupled to the left cavity and configured to detect an indicator of a left ocular environment within the left cavity, and a right cavity sensor coupled to the right cavity and configured to detect an indicator of the right ocular environment within the right cavity. (Appendix 43) 42. The apparatus of claim 41, wherein the differential sensor includes a differential pressure sensor configured to sense a difference between an indication of left pressure in the left cavity sensed by a left differential pressure sensor and an indication of right pressure in the right cavity sensed by a right differential pressure sensor. (Appendix 44) 42. The apparatus of claim 41, wherein the differential sensor includes a differential signal sensor configured to sense a difference between an indication of left pressure from the left cavity sensor by a left differential signal sensor and an indication of right pressure from the right pressure sensor by a right differential signal sensor. (Appendix 45) 42. The apparatus of claim 41, comprising a system control circuit in communication with the pressure source and configured to receive and process at least one of an indication of the left ocular environment in the left cavity, an indication of the right ocular environment in the right cavity, and an indication of a relationship between the indication of the left ocular environment and the indication of the right ocular environment. (Appendix 46) 46. The apparatus of claim 45, wherein the indicator of the left ocular environment includes an indicator of left pressure in the left cavity, the indicator of the right ocular environment includes an indicator of right pressure in the right cavity, and the indicator of a relationship between the left ocular environment and the right ocular environment includes an indicator of a difference between the indicator of left pressure and the indicator of right pressure. (Appendix 47) 46. The apparatus of claim 45, wherein the system control circuitry includes a pressure source circuit configured to adjust operation of the pressure source based on at least one of the received indicators. (Appendix 48) 48. The apparatus of claim 47, wherein the pressure source circuit includes a pressure source logic circuit configured to initiate a system fault based on at least one of the received indicators. (Appendix 49) 9. The apparatus of claim 8, comprising a pressure source circuit configured to cause the system fault when at least one of the indication of left pressure exceeds a left pressure safety level or the indication of right pressure exceeds a right pressure safety level. (Appendix 50) the index of the relationship between the left eye environment and the right eye environment includes an index of a difference between the index of the left pressure and the index of the right pressure, 49. The apparatus of claim 48, comprising a pressure source circuit configured to cause the system fault if the difference indication exceeds a pressure differential safety level between the left pressure and the right pressure. (Appendix 51) 42. The apparatus of claim 41, comprising a left valve in communication with the left cavity and configured to limit fluid pressure in the left cavity to a left pressure safety level; and a right valve in communication with the right cavity and configured to limit fluid pressure in the right cavity to a right pressure safety level. (Appendix 52) 52. The apparatus of claim 51, wherein at least one of the left pressure safety level and the right safety pressure level is in the range of about -50 mmHg to about 50 mmHg gauge. (Appendix 53) 52. The apparatus of claim 51, wherein at least one of the left pressure safety level and the right pressure safety level is in the range of about -35 mmHg to about 35 mmHg gauge. (Appendix 54) 52. The apparatus of claim 51, wherein at least one of the left valve and the right valve comprises a passive valve. (Appendix 55) 52. The apparatus of claim 51, wherein at least one of the left valve and the right valve comprises an active valve. (Appendix 56) 13. A method of using an apparatus, the apparatus comprising: a pressure source in communication with a left cavity overlying a left eye of a patient and a right cavity overlying a right eye of a patient; and a system sensor including a left cavity sensor for sensing an indicator of a left ocular environment in the left cavity, a right cavity sensor for sensing an indicator of a right ocular environment in the right cavity, and a redundant sensor for sensing a relationship between the indicator of the left ocular environment and the indicator of the right ocular environment, the method comprising: sensing with the system sensors an indication of left pressure in the left cavity and an indication of right pressure in the right cavity; and limiting pressure applied by the pressure source to the left and right cavities. (Appendix 57) the apparatus includes at least one of a left passive valve in communication with the left cavity and a right passive valve in communication with the right cavity; 57. The method of claim 56, wherein limiting pressure includes selecting at least one of a left cracking pressure of the left passive valve and a right cracking pressure of the right passive valve. (Appendix 58) the apparatus includes at least one of a left active valve in communication with the left cavity and a right active valve in communication with the right cavity; 57. The method of claim 56, wherein limiting pressure includes opening at least one of the left active valve and the right active valve based on at least one of the indication of the sensed left pressure and the indication of the sensed right pressure. (Appendix 59) 59. The method of claim 58, wherein opening at least one of the left active valve and the right active valve includes opening at least one of the left active valve and the right active valve based on a difference between the indication of the sensed left pressure and the indication of the sensed right pressure. (Appendix 60) 57. The method of claim 56, wherein limiting pressure includes adjusting operation of the pressure source based on at least one of the indication of the detected left pressure and the indication of the detected right pressure.
Claims
1. 1. An apparatus for adjusting fluid pressure applied to at least one of a left cavity located over a left eye of a patient and a right cavity located over a right eye of the patient to treat, inhibit, or prevent an ocular disorder, the apparatus comprising: a differential sensor in communication with the left cavity and the right cavity and configured to sense at least one of an indicator of a left ocular environment in the left cavity, an indicator of a right ocular environment in the right cavity, and an indicator of a relationship between the indicator of the left ocular environment and the indicator of the right ocular environment, the differential sensor including a differential pressure sensor configured to sense a difference between an indicator of left pressure in the left cavity sensed by a left pressure sensor and an indicator of right pressure in the right cavity sensed by a right pressure sensor; and a control circuit in communication with the differential sensor and configured to receive and process at least one of an indication of the left eye environment in the left cavity, an indication of the right eye environment in the right cavity, and an indication of a relationship between the indication of the left eye environment and the indication of the right eye environment.
2. 2. The apparatus of claim 1, comprising at least one of a left cavity sensor coupled to the control circuit and configured to sense an indicator of a left ocular environment in the left cavity, or a right cavity sensor coupled to the control circuit and configured to sense an indicator of a right ocular environment in the right cavity.
3. 2. The apparatus of claim 1, wherein the differential sensor comprises a differential signal sensor configured to sense a difference between an indication of left pressure from a left pressure sensor sensed by a left signal sensor and an indication of right pressure from a right pressure sensor sensed by a right signal sensor.
4. The apparatus of claim 1 , comprising a pressure source in communication with at least one of the left cavity and the right cavity and configured to apply a non-atmospheric pressure to at least one of the left cavity and the right cavity.
5. The apparatus of claim 4 , wherein the pressure source comprises a pressure source configured to apply a non-atmospheric pressure to the left cavity and the right cavity.
6. a left cavity valve in communication with the left cavity and configured to adjust an indication of a left pressure within the left cavity; 3. The apparatus of claim 2, further comprising: a right cavity valve in communication with the right cavity and configured to adjust an indication of a right pressure within the right cavity.
7. The apparatus of claim 6 , wherein at least one of the left cavity valve and the right cavity valve comprises a passive valve.
8. The apparatus of claim 6 , wherein at least one of the left cavity valve and the right cavity valve comprises an active valve.
9. a left biosensor in communication with the control circuitry and configured to sense at least one of an indication of left intraocular pressure (IOP) in the left eye and an indication of cerebrospinal fluid pressure (CSFP) in the patient; a right biosensor in communication with the control circuit and configured to sense at least one of an indication of a right IOP in the right eye and an indication of a CSFP in the patient; 7. The apparatus of claim 6, wherein the left cavity valve includes an active left valve configured to adjust the indication of left pressure based on at least one of the indications received from the left biosensor, and the right cavity valve includes an active right valve configured to adjust the indication of right pressure based on at least one of the indications received from the right biosensor.
10. the control circuitry includes a left control circuit configured to receive the indication of left IOP and adjust a left pressure in the left cavity toward a left target IOP level via the active left valve based on the received indication of left IOP; 10. The apparatus of claim 9, wherein the control circuitry includes a right control circuit configured to receive the indication of right IOP and adjust the right pressure in the right cavity toward a right target IOP level via the active right valve based on the received indication of right IOP.
11. the control circuitry includes a left control circuit configured to adjust a left pressure in the left cavity by the active left valve to equalize a measure of a left transcriboid pressure difference (TPD) associated with the left eye; Equalizing the left TPD index includes reducing the left TPD index from a first left TPD level to a second lower left TPD level; the control circuit includes a right control circuit configured to adjust the right pressure in the right cavity by the active right valve to equalize an index of right TPD associated with the right eye; 10. The apparatus of claim 9, wherein equalizing the measure of right TPD includes reducing the measure of right TPD from a first right TPD level to a lower second right TPD level.
12. the control circuit includes a left control circuit configured to adjust a left pressure in the left cavity by the active left valve to improve an indication of axonal transport in the left optic nerve of the left eye; the control circuit includes a right control circuit configured to adjust a right pressure in the right cavity by the active right valve to improve an indication of axonal transport in the right optic nerve of the right eye; 10. The device of claim 9, wherein improving the indicator of axonal transport comprises increasing a rate of axonal transport from a first axonal transport level to a second higher axonal transport level.
13. the control circuit includes a left control circuit configured to regulate a left pressure in the left cavity by the active left valve to treat, inhibit, or prevent an ocular disease in the left eye; 10. The device of claim 9, wherein the control circuitry includes a right control circuit configured to regulate a right pressure in the right cavity by the active right valve to treat, inhibit, or prevent an ocular disease in the right eye.
14. 2. The apparatus of claim 1, comprising a passive left valve in communication with the left cavity and configured to limit a left pressure in the left cavity to a left cracking pressure, and a passive right valve in communication with the right cavity and configured to limit a right pressure in the right cavity to a right cracking pressure.
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