Systems, devices, and methods for monitoring and / or controlling pressure of a fluid

Abstract

Embodiments of the present disclosure relate to an implant for implantation into a vessel or bodily area / cavity of the body and, in some embodiments, includes a pressure sensor that determines a bodily fluid pressure within a bodily fluid cavity or vessel, and / or a magnetic valve assembly, for controlling pressure of the bodily fluid within the vessel or bodily area. The valve, in some embodiments, includes at least one magnet and an ASIC sensor for determining at least one characteristic of the at least one magnet, including, for example, position and magnetic field strength. In some embodiments, the implant includes a second magnet, where like poles of the first and the second magnets face one another so as to operate as a valve upon exposure of one of the magnets to the pressure of the bodily fluid within the bodily area.

Description

SYSTEMS, DEVICES, AND METHODS FOR MONITORINGAND / OR CONTROLLING PRESSURE OF A FLUIDRelated Applications

[0001] This disclosure claims benefit of and priority to U.S. provisional patent application no. 63 / 560,628, filed March 1, 2024, and entitled, “Systems, Devices, and Methods for Monitoring Pressure of a Bodily Fluid,” the entire disclosure of which is herein incorporated by reference.Technical Field

[0002] Embodiments described herein relate to fluid pressure monitoring sensors, as well as fluid pressure controlling devices. More particularly, embodiments of the disclosure are directed to bodily fluid pressure-sensing and bodily fluid pressure controlling technology that includes a magnetic mechanism.Background

[0003] Open-angle glaucoma (OAG) is a prevalent and potentially debilitating eye disease that affects millions of individuals worldwide (more than 80 million people worldwide). OAG is characterized by gradual, painless damage to the optic nerve, often leading to vision impairment or blindness if left untreated. Among the various risk factors associated with OAG, advancing age, family history of the disease, and ethnicity are noteworthy contributors (individuals of African ancestry and certain Asian populations are at high risk). As the aging population continues to grow, the incidence of glaucoma is expected to rise, presenting a significant healthcare challenge.

[0004] One of the key factors associated with the development and progression of OAG is intraocular pressure (IOP). Intraocular pressure refers to the fluid pressure within the eye's anterior chamber, primarily determined by the balance between the production and drainage of aqueous humor. Elevated IOP is a primary risk factor for glaucoma, as it can lead to mechanical compression and damage of the optic nerve, resulting in vision loss.

[0005] The precise management of IOP is crucial in the clinical care of glaucoma patients. Monitoring IOP allows clinicians to assess disease progression, tailor treatment regimens, andmake timely interventions to preserve vision. Furthermore, IOP fluctuations throughout the day, known as diurnal variations, can influence the progression of glaucoma. Therefore, continuous and accurate monitoring of IOP is of paramount importance for effective glaucoma management.

[0006] Despite the recognized significance of IOP monitoring, existing methods have notable limitations. Conventional techniques involve periodic measurements obtained during clinic visits, providing only a snapshot of IOP dynamics. This intermittent monitoring fails to capture important variations in IOP, which can occur throughout the day and night. For many patients, particularly those with limited access to healthcare, attending in-person clinic visits can be challenging. Moreover, patient compliance with follow-up appointments is known to be lacking, potentially resulting in suboptimal disease management.

[0007] Non-invasive methods used at home offer some advantages in terms of patient convenience. However, they too have their limitations. For example, these methods typically rely on external devices that can be uncomfortable to wear for extended periods and may not provide continuous monitoring. For elderly patients, operating these devices can be challenging due to technological complexities. Additionally, they rely heavily on patient compliance; however, patients may forget to take measurements or find the process cumbersome, potentially leading to gaps in data collection and suboptimal disease management.

[0008] Invasive methods for IOP monitoring, while offering continuous measurements, present their own set of challenges. Some invasive devices rely on batteries that require periodic recharging, raising concerns about safety and potential heat generation during the recharging process. This creates an additional layer of patient compliance that can be burdensome.

[0009] Furthermore, invasive methods are susceptible to sensor drifting, which can result in inaccurate measurements over time.

[0010] Sensor drifting refers to the phenomenon where the measurements obtained from a sensor or device gradually deviate or change over time without any corresponding changes in the actual parameter being measured, in this case, intraocular pressure (IOP). Sensor drifting can occur for various reasons, including material fatigue in sensors that rely on multilayer polymers or elastic membranes. Over time, the materials in the sensor may undergo wear and fatigue due to repeated pressure changes, temperature fluctuations, and exposure to bodily fluids, leading to changes in the sensor's performance. As a result, recurrent calibration is oftennecessary to correct for sensor drifting and maintain measurement accuracy, introducing complexity and potential challenges in both patient and physician compliance. Achieving the level of accuracy required for IOP monitoring, particularly within the range of +2 mmHg to -2 mmHg compared to Goldman tonometry, the gold standard pressure measurement method, has been a persistent concern.

[0011] Some existing technologies include ocular implants for IOP monitoring (e.g., Eyemate IO). However, clinical trials in which the implant’s pressure measurements were compared to the gold standard method for pressure measurement (GAT- Goldmann Applantaion Tonometry) demonstrated a 95% confidence interval of limits of agreement of 10.2 to -3.8 mmHg, suggesting possible issues interpreting individual results on top of some safety concerns. Other implant devices (e.g., Eyemate SC) when 12-month performance and accuracy was evaluated, showed there might be a need for recurrent sensor calibration due to signal drifting (different levels of agreement with gold standard measurements over time). Furthermore, the 95% confidence interval of limits of agreement was -5.1 to 6.7 mmHg, implying a margin for improvement in terms of clinically meaningful accuracy. Lastly, other existing implants (e.g., IOP Connect, QSmart) are designed to operate on battery power, requiring extra safety measures and recurrent battery recharge that could potentially prove to be harmful due to heat generation during the battery recharge process and require an extra layer of patient compliance.

[0012] Given the multifaceted challenges associated with existing methods, there is a compelling need for improved technologies that overcome these limitations, enabling continuous, accurate, and safe IOP monitoring for individuals with glaucoma, while minimizing the demands on both patients and healthcare providers. To address these challenges effectively, the ideal pressure sensor for intraocular pressure monitoring should possess several key attributes, including exceptional accuracy, longevity to mitigate sensor drifting over time, freedom from reliance on batteries to ensure patient safety and convenience, and biocompatibility to minimize the risk of adverse reactions within the eye. Developing such a sensor represents a critical advancement in the field of ophthalmology, with the potential to revolutionize glaucoma management and improve the quality of life for patients worldwide.

[0013] Despite the recognized significance of IOP monitoring, existing methods have notable limitations. For example, non-invasive methods lack accuracy and do not allow for continuous monitoring, whereas invasive methods are prone to sensor drifting and require recharging.Therefore, there is a need for systems, devices, and methods that enable monitoring, and / or controlling intraocular pressure that address drawbacks of current systems.Summary of The Disclosure

[0014] In some embodiments of the present disclosure, a bodily fluid pressure monitoring method is provided and includes implanting at least part of a housing of a bodily-fluid pressure sensing device (PSD) within or adjacent to a fluid-containing cavity (which may also be referred to in this disclosure as a fluid container area), or vessel, where the housing includes an inner volume (which may also be referred to as a chamber or first chamber, i.e., chamber and volume used interchangeably, such terms used interchangeably throughout) divided into a first portion and a second portion by a first magnet. The second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon a pressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume. The method can further include sensing a characteristic of the first magnet based on the position of the first magnet within the inner volume, where the position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, and the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel, and determining the pressure of the bodily fluid within the cavity or vessel can be determined based on the sensed characteristic of the first magnet.

[0015] Such embodiments may include one and / or another of (and in some embodiments, if not mutually exclusive, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the following features, functionality, steps, structure, and clarifications:- the housing includes a second magnet, where the second magnet can be arranged within the first portion of the inner volume; like poles of each of the first magnet and the second magnet are arranged such that they face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet; o repulsive force(s) counterbalances intraocular pressure (IOP) fluctuations;o one or more (preferably all) of magnets used in at least some embodiments are high-grade neodymium N52 magnets (although alternative magnet types with comparable force characteristics may also be used); o generated repulsive force(s) is configured to oppose pressure exerted by a fluid volume within the IOP range of 0-30 mmHg; and / or o generated repulsive force(s) can be achieved by configuring at least one of (and preferably a plurality of, and more preferably all of) the magnetic field strength, polarity, and spatial arrangement, to produce a controlled repulsive force(s) that correlates with the hydrostatic pressure acting on the implant / device, the force(s) output is tunable based on at least one of (and preferably a plurality of, and more preferably, all of) magnet selection, geometry, and separation distance, allowing adaptability for various clinical applications;- the characteristic is magnetic field, and the sensor comprises a magnetic field sensor;- the magnetic field sensor is arranged at a first location on or adjacent the housing;- the PSD comprises a micro-electromechanical system (MEMS);- the magnetic field sensor is configured to sense a magnetic field strength;- the strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel;- the strength of the magnetic field of the first magnet depends on its location relative to the magnetic field sensor;- the strength of the magnetic field of the first magnet depends on its location relative to the first location;- the positions of the first magnet within the inner volume is additionally determined by a / the repulsive force generated between the first magnet and the second magnet;- the first portion of the inner volume includes a medium or structure to retain or aid in retaining the first magnet at a particular position within the inner volume;- the housing comprises any geometric shape including a tubular structure;- the housing includes a vent configured to vent the first portion;o the vent can be configured to allow a / the medium contained within first portion to flow in and / or out of the vent; a second housing, the second housing optionally comprises any geometric shape including a tubular shape;- the second housing including a second inner volume (which may also be referred to as a chamber or a second chamber, such terms used interchangeably herein throughout) is configured to allow a / the medium from the first portion to flow into and / or out of the second inner volume via a / the vent; a seal;- the first magnet includes a seal; at least one of receiving and transmitting radio-frequency (RF) signals;- the housing includes or is arranged adjacent to an application-specific-integrated-chip (ASIC);- the magnetic field sensor is a component of an / the application-specific-integrated-chip (ASIC);- the RF signals are received and / or transmitted via the ASIC; at least one of the housing and the ASIC include an antenna for ultimately receiving and / or transmitting RF signals;- the bodily fluid pressure within the cavity or vessel is determined by at least one of the ASIC and an external device;- transmitting the determined bodily fluid pressure via RF signals; harvesting energy from RF-signals transmitted to the PSD, the energy used to power the PSD; harvesting energy is accomplished by a / the ASIC;- the PSD is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the PDS and instructing the PSD to determine and / or transmit the characteristic of the first magnet;- the external device determines the bodily fluid pressure within the cavity or vessel based on the transmitted characteristic;at least one of the first magnet and a / the second magnet comprises neodymium; at least one of the housing and a / the second housing comprises a biocompatible nonmagnetizing material;- the non-magnetizing material comprises a polymer; at least one of the first magnet and a / the second magnet are each enclosed in a biocompatible non-magnetizing material; the non-magnetizing material comprises a polymer which may be PMMA;- the non-magnetizing material is hydrophobic;- the magnetic field sensor provides one or more signals corresponding the sensed magnetic fields of the first magnet;- the PSD further includes an analog-to-digital converter (ADC) configured to convert analog signals from the MEMS into a digital signal;- the ADC is part of a / the application-specific-integrated-chip (ASIC); a thickness of the PSD does not exceed 3 mm (in some embodiments, between 0.25mm- 1mm, 0.5mm-1.5mm, 0.75mm-2mm, lmm-2mm, or between lmm-3mm, and ranges therebetween of any of the preceding); a length of the PSD does not exceed 10 mm; (in some embodiments, between 2mm- 10mm, 3mm- 10mm, 4mm-8mm, 6mm-7mm, or between 5mm- 10mm, and ranges therebetween of any of the preceding); a width of the PSD does not exceed 3 mm; (in some embodiments, between 0.25mm- 1mm, 0.5mm-1.5mm, 0.75mm-2mm, lmm-2 mm, or between lmm-3mm, and ranges therebetween);- the first housing and the second housing are arranged parallel to one another; an inner diameter of the second housing is greater than an inner diameter of the first housing;- the inner diameter of the second housing is at least twice the size of the inner diameter of the first housing;- the inner diameter of the first housing does not exceed 0.80 mm (in some embodiments, between 0.05mm-0.8mm, 0.1mm-0.8mm, and ranges therebetween of any of thepreceding) and the inner diameter of the second housing does not exceed 1.5 mm (in some embodiments, between 0.2mm-1.5mm, 0.5mm-1.5mm, and ranges therebetween of any of the preceding);- the inner diameter of the second housing is configured such that compression of the medium in the first housing is less than 2mm (in some embodiments, between 0.5mm- 2mm, between 0.5mm-lmm, between 0.5mm-1.5mm, and ranges between any of the preceding); as the bodily fluid flows into the second portion of the first inner volume causing the first magnet to move in a first direction away from the opening; as the bodily fluid flows out from the second portion of the inner volume causing the first magnet to move in a second direction towards the opening;- bodily fluid flows into the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel increases and flows out of the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel decreases;- the distance between the first magnet and the second magnet depends on an equilibrium between the repellant force between the first magnet and second magnet and a force applied on the first magnet by a volume of bodily fluid flowing into the second portion of the inner volume;- the bodily fluid is ocular fluid and the cavity is at least a portion of a segment or chamber of an eye of the patient; and- the bodily fluid is ocular fluid and the cavity is at least a portion of the anterior segment of an eye of the patient.

[0016] In some embodiments, a bodily fluid pressure monitoring device is provided and includes a housing, at least a portion of which is configured for implantation within or adjacent to a fluid-containing cavity or vessel, wherein the housing includes an inner volume divided into a first portion and a second portion by a first magnet. The second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon a pressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume. The device also includes a sensor configured to sense a characteristic of the first magnet based onthe position of the first magnet within the inner volume. The position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, and the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel. The pressure of the bodily fluid within the cavity or vessel can be determined based on the sensed characteristic of the first magnet.

[0017] In some embodiments, an implantable pressure regulating device for regulating a bodily fluid within a body vessel or bodily area, and includes a biocompatible housing including a size, shape, and material for seamless integration with or within tissue while minimizing an inflammatory response thereof, the biocompatible housing including a first chamber, a conduit that connects the first chamber to a drainage site; and a pressure-sensitive magnetic valve (PSMV) assembly positioned within or adjacent to the conduit, the PSMV configured for selective fluid flow based on one or more lOPs. The magnetic valve include a first magnet arranged so as to respond to an IOP level to modulate an open and a closed state of the valve and a second magnet arranged with respect to the first magnet such that like poles of each of the first magnet and the second magnet face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.

[0018] Such embodiments, both at least with respect to two preceding paragraphs, may include one and / or another of (and in some embodiments, if not mutually exclusive, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the following features, functionality, steps, structure, and clarifications:- the housing includes a second magnet;- the second magnet is arranged within the first portion of the inner volume; like poles of each of the first magnet and the second magnet are arranged such that they face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet;- the characteristic is magnetic field, and the sensor comprises a magnetic field sensor;- the magnetic field sensor is arranged at a first location on or adjacent the housing;- the device comprises a micro-electromechanical system (MEMS);- the magnetic field sensor is configured to sense a magnetic field strength;- the strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel;- the strength of the magnetic field of the first magnet depends on its location relative to magnetic field sensor;- the strength of the magnetic field of the first magnet depends on its location relative to the first location;- the positions of the first magnet within the inner volume is additionally determined by a / the repulsive force generated between the first magnet and the second magnet;- the first portion of the inner volume includes a medium or structure to retain or aid in retaining the first magnet at a particular position within the inner volume;- the housing comprises a tubular structure;- the housing includes a vent configured to vent the first portion; o the vent can be configured to allow a / the medium contained within first portion to flow in and / or out of the vent; a second housing;- the second housing including a second inner volume is configured to allow a / the medium from the first portion to flow into and / or out of the second inner volume via a / the vent; a seal;- the first magnet includes a seal; at least one of receiving and transmitting radio-frequency (RF) signals;- the housing includes or is arranged adjacent to an application-specific-integrated-chip (ASIC), and wherein optionally, the ASIC comprises or includes a determination means for determining the pressure of the bodily fluid within the cavity or vessel based on the sensed characteristic of the first magnet;- the magnetic field sensor is a component of an / the application-specific-integrated-chip (ASIC);- the RF signals are received and / or transmitted via the ASIC; at least one of the housing and the ASIC include an antenna for ultimately receiving and / or transmitting RF signals;- the bodily fluid pressure within the cavity or vessel is determined by the ASIC;- transmitting the determined bodily fluid pressure via RF signals; harvesting energy from RF-signals transmitted to the device, the energy used to power the device; harvesting energy is accomplished by a / the ASIC;- the device is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the device and instruct the device to determine the bodily fluid pressure within the cavity or vessel to which the device is implanted; at least one of the first magnet and a / the second magnet comprises neodymium; at least one of the housing and a / the second housing comprises a biocompatible nonmagnetizing material;- the non-magnetizing material comprises a polymer; at least one of the first magnet and a / the second magnet are each enclosed in a biocompatible non-magnetizing material; the non-magnetizing material comprises a polymer which may be PMMA;- the non-magnetizing material is hydrophobic;- the MEMS transmits one or more signals corresponding the sensed magnetic fields of the first magnet;- the device further includes an analog-to-digital converter (ADC) configured to convert analog signals from the MEMS into a digital signal;- the device is part of a / the application-specific-integrated-chip (ASIC); a thickness of the device does not exceed 3 mm (in some embodiments, between 0.25mm-lmm, 0.5mm-1.5mm, 0.75mm-2mm, lmm-2mm, or between lmm-3mm, and ranges therebetween of any of the preceding); a length of the device does not exceed 10 mm (in some embodiments, between 2mm- 10mm, 3mm- 10mm, 4mm-8mm, 6mm-7mm, or between 5mm- 10mm, and ranges therebetween of any of the preceding);a width of the device does not exceed 3 mm (in some embodiments, between 0.25mm- 1mm, 0.5mm-1.5mm, 0.75mm-2mm, lmm-2 mm, or between lmm-3mm, and ranges therebetween);- the first housing and the second housing are arranged parallel to one another; an inner diameter of the second housing is greater than an inner diameter of the first housing;- the inner diameter of the second housing is at least twice the size of the inner diameter of the first housing;- the inner diameter of the first housing does not exceed 0.80 mm (in some embodiments, between 0.05mm-0.8mm, 0.1mm-0.8mm, and ranges therebetween of any of the preceding) and the inner diameter of the second housing does not exceed 1.5 mm (in some embodiments, between 0.2mm-1.5mm, 0.5mm-1.5mm, and ranges therebetween of any of the preceding); as the bodily fluid flows into the second portion of the first inner volume causing the first magnet to move in a first direction away from the opening; as the bodily fluid flows out from the second portion of the inner volume causing the first magnet to move in a second direction towards the opening;- bodily fluid flows into the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel increases and flows out of the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel decreases;- the distance between the first magnet and the second magnet depends on an equilibrium between the repellant force between the first magnet and second magnet and a force applied on the first magnet by a volume of bodily fluid flowing into the second portion of the inner volume; and- the bodily fluid is ocular fluid and the cavity is at least a portion of a segment or a chamber of an eye of the patient.

[0019] In some embodiments, a bodily fluid pressure monitoring system is provided and includes a device according to any of the device, and an external unit configured for any of communication and supplying power to the device, as well as a / the determination means fordetermining the pressure within the fluid containing cavity or vessel. In such embodiments, the determination means comprises a processor, the determination means comprises an application-specific-integrated-chip (ASIC). The external unit can be configured to at least one of transmission of RF-signals at a predetermined frequency to a / the ASIC and receive data transmitted via RF-signals by the device.

[0020] Such embodiments may include one and / or another of (and in some embodiments, if not mutually exclusive, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the following features, functionality, steps, structure, and clarifications:- the determination means includes a processor;- the determination means includes an application-specific-integrated-chip (ASIC);- the external unit is configured to at least one of transmission of RF-signals at a predetermined frequency to a / the ASIC and receive data transmitted via RF-signals by the device; and- the external unit includes a memory configured to store data and a display for displaying information to a user.

[0021] In some embodiments, a method for dynamically regulating fluid outflow in response to pressure (IOP) fluctuations is provided. In some embodiments, this is for regulating pressure of a fluid within a body cavity or vessel (e.g., ocular fluid in the eye). In some embodiments, the functionality can be applied to other subject areas including other animals, as well as other non-life science areas (e.g., commercial and industrial applications). In some embodiments, the method includes magnetically controlling a valve that opens when pressure fluid pressure within a cavity or vessel exceeds a predefined threshold (e.g., intraocular pressure, or IOP, within the eye).

[0022] Such embodiments may include one and / or another of (and in some embodiments, if not mutually exclusive, a plurality of) the following features, functionality, steps, structure, and clarifications: magnetically controlling the valve includes closing the valve upon normalization of the IOP;dynamically regulating fluid outflow and / or controlling the valve is performed without the need of a stand-alone power source; and operation of the valve minimization of a risk of hypotony by preventing excessive drainage when the IOP is within a physiological range.

[0023] In some embodiments, an implantable pressure regulating device for regulating a bodily fluid within a body vessel or bodily area, and includes a biocompatible housing including a size, shape, and material for seamless integration with or within tissue while minimizing an inflammatory response thereof, the biocompatible housing including a first chamber, a conduit that connects the first chamber to a drainage site; and a pressure-sensitive magnetic valve (PSMV) assembly positioned within or adjacent to the conduit, the PSMV configured for selective fluid flow based on one or more lOPs. The magnetic valve include a first magnet arranged so as to respond to an IOP level to modulate an open and a closed state of the valve and a second magnet arranged with respect to the first magnet such that like poles of each of the first magnet and the second magnet face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.

[0024] In some embodiments, a movable magnetic device operatively coupled to a valve to modulate fluid passage based on pressure variations is provided.

[0025] Magnets used in any of the disclosed embodiments, can use a multitude of different magnet type and material, including, but not limited to any material, device, or system capable of generating a repulsive force within a pressure range (e.g., IOP of 0-30mm Hg), including alternative permanent magnets, electromagnets, or hybrid magnetic assemblies designed to achieve the same functional effect. In some embodiments, the pressure range can be between l-30mmHg, 2-30mmHg, 5-30mmHg, 10-30mmHg, 15-30mmHg, 20-30mmHg, 25-30mmHg, and ranges between any of the preceding).

[0026] These and other embodiments of the inventions disclosed herein will be made even more clear by reference to the following detailed description and drawings, a brief description of which is provided immediately below.Brief Description of the Drawings

[0027] FIG. 1 is a schematic block diagram of a system for monitoring intraocular pressure, according to some embodiments of the disclosure.

[0028] FIG. 2A is a diagram of a cross-section of an implant for monitoring intraocular pressure, according to some embodiments of the disclosure.

[0029] FIG.2B is a diagram of an electronic circuitry of the implant for monitoring intraocular pressure, according to some embodiments of the disclosure.

[0030] FIG. 3 is an upper plan view of the implant for monitoring intraocular pressure, according to some embodiments of the disclosure.

[0031] FIG. 4 is a lower plan view of the implant for monitoring intraocular pressure, according to some embodiments of the disclosure.

[0032] FIG. 5 shows a magnet of the implant with a coating, according to some embodiments of the disclosure.

[0033] FIG. 6A shows the implant under high intraocular pressure conditions, according to some embodiments of the disclosure.

[0034] FIG. 6B shows the implant under low intraocular pressure conditions, according to some embodiments of the disclosure.

[0035] FIG. 7 depicts forces acting on the magnet of FIG. 5, according to some embodiments of the disclosure.

[0036] FIG. 8 is a flowchart of an example method of using a system including an implant to monitor intraocular pressure, according to some embodiments of the disclosure.

[0037] FIG. 9 is a diagram of a cross-section of an intraocular pressure-regulated magnetic drainage system, according to some embodiments of the disclosure.

[0038] FIG. 10A shows the intraocular pressure-regulated magnetic drainage system under high intraocular pressure conditions, according to some embodiments of the disclosure.

[0039] FIG. 10B shows the intraocular pressure-regulated magnetic drainage system under low intraocular pressure conditions, according to some embodiments of the disclosure.Detailed Description

[0040] The primary objective of at least some of the embodiments of the inventions disclosed herein is an advanced implantable pressure sensor designed for the monitoring, and / or (in some embodiments), control of intraocular pressure (IOP). Importantly, embodiments disclosed herein were developed for accuracy and longevity. By focusing on providing precise andreliable measurements over an extended period, embodiments of the present disclosure address the need for a more effective and durable solution in managing conditions such as glaucoma.

[0041] Accordingly, embodiments described herein relate to an implant including a pressure sensor that uses a repulsive magnetic force acting between two magnets and a magnetic field sensor to accurately gauge intraocular pressure. In some embodiments, a / the magnet may be subject to magnetic repulsive force from one side, and intraocular pressure from an opposite side, such that the location of the magnet along a tube changes depending on the equilibrium point where magnetic repulsion equals the force generated by the intraocular pressure. In some embodiments, the location of the magnet in the tube is monitored using a magnetic field sensor placed at the point where intraocular fluid enters the implant. In some embodiments, measurements of the magnetic field can be used to calculate the intraocular pressure.

[0042] In some embodiments, the pressure sensor includes a compliant membrane that prevents intraocular fluid from leaking into a medium disposed in the tube between the repulsive magnets. In some embodiments, the compliant membrane may be coupled to the magnet such that the compliant membrane allows the intraocular fluid to exert force on the moving magnet through the compliant membrane.

[0043] In some embodiments, by employing magnetic components, the pressure sensor ensures not only precision, but also an extended operational lifespan. Lack of a battery-free approach allows for passive monitoring of IOP and enables timely interventions thereby enhancing overall management of ocular conditions.

[0044] In some embodiments, the implant includes Micro-electromechanical System (MEMS), application-specific integrated circuit (ASIC), and a communication interface (e.g., an antenna) to receive momentary energy supply through a radio frequency energy harvesting mechanism, collect intraocular pressure data, and to transmit IOP data to an external reading device. Such data transmission ensures that healthcare professionals can access comprehensive and up-to-date IOP records, facilitating informed decision-making in the management of ocular health.

[0045] FIG. 1 is a schematic diagram of a system 1000 including implant 100 for monitoring a pressure of a bodily fluid, including, for example, intraocular pressure, according to some embodiments. As shown, the implant 100 may include a housing 105 (or one or more housings 105) including a medium 109, one or more magnet(s) 103, and optionally, a compliant member, which can be referred to as a seal, 104 disposed therein. In some embodiments, the housing105 may be or include one or more tubular members. “Tubular,” s (for example, in some embodiments, any geometric shape can be used, thus “tubular” will be used throughout to include any geometric shape) members. For example, the housing 105 may include a first tubular member and a second tubular member in fluid communication with one another via an opening positioned along a sidewall of each tubular member. The implant, according to some embodiments, may be considered a micro-electromechanical system (MEMS).

[0046] In some embodiments, the housing 105 (e.g., one or more of the tubular members) may define an inner volume which can be configured to hold or contain a medium 109. The first tubular member may define a first inner volume, and the second tubular member may define a second inner volume. In some embodiments, the first inner volume of the first tubular member may include a first portion configured to hold or contain the medium 109, and a second portion configured to be in fluid communication with the vessel or bodily fluid cavity (e.g., anterior chamber of the eye). In some embodiments, the one or more magnet(s) 103 may include a single magnet, and in some embodiments, a pair of magnets disposed adjacent to or in the first portion of the first inner volume. For example, a first (or single) magnet (which divides the first inner volume into the first and second portions) may produce a magnetic field that changes depending on a position of the first magnet relative to a sensor on the device, which is located adjacent the first volume. For example, as the first magnet moves closer to the sensor, the sensed magnetic field of the first magnet increases. Such movement of the first magnet is based on at least the bodily fluid pressure moving the first magnet along the first inner volume.

[0047] In some embodiments, a second magnet may be affixed to an end of the first tubular member (and in some embodiments, adjacent the first portion), which is arranged such that like-poles of the first and second magnet face each other such that a repulsive magnetic field is established between the first and second magnets. This functionality can be used in addition to or in place of the medium contained in the first portion of the first inner volume, so as to position the first magnet so that its magnetic field can be adequately sensed by the sensor, i.e., sense the magnetic field of the first magnet as it moves in the first inner volume and is balanced between the first portion and the second portion by the bodily fluid pressure and the repulsive force generated between the two magnets.

[0048] Accordingly, in some embodiments, a distance between the first magnet and the second magnet may be dependent on at least one of (i) the repulsive force between the first magnet and the second magnet and (ii) a volume of bodily fluid (e.g., the aqueous humour 110) in the second portion of the first inner volume acting on the first magnet. In some embodiments, themagnet(s) 103 may include a coating disposed around at least a portion thereof. For example, the first magnet and / or the second magnet may each be encapsulated in a polymeric coating. The polymeric coating may help the first magnet to move smoothly through the first tubular member (e.g., may reduce friction between the first magnetic and an inner wall of the first tubular member).

[0049] In some embodiments, a seal (e.g., a compliant member, a membrane, a plug, etc.) 104 may be operatively coupled to or disposed in first tubular member and configured to fluidically isolate the first portion of the first inner volume from the second portion of the first inner volume. The seal 104 may be affixed to the first magnet and / or arranged adjacent to an end of the first magnet. The seal 104 may be configured to allow movement of the first magnet relative to the second magnet. For example, as a volume of intraocular fluid (e.g., the aqueous humour 110) flows into the second portion of the first inner volume, the intraocular fluid may exert a force on the seal 104 causing the seal 104 to deform (e.g., in a first direction). The deformation of the seal 104 may allow the fluid to exert the force on the first magnet. Conversely, as intraocular fluid 110 flows out of the second portion of the first inner volume, the repellant force acting on the first magnet may be greater than the force exerted by the intraocular fluid 110 such that the repellant force pushes the first magnet away from the second magnet. In response to the first magnet being repelled, the seal 104 may deform (e.g., in a second direction opposite the first direction) to allow the first magnet to move away from the second magnet.

[0050] The medium 109 may include any suitable liquid, gas, semi-liquid and / or semi-solid material. For example, the medium 109 may include, for example, medical air. In some embodiments, as the first magnet moves closer to the second magnet, the medium 109 may flow from the first portion of the first inner volume to the second inner volume of the second tubular member via the first opening. Conversely, as the first magnet moves away from the second magnet, the medium 109 may flow from the second inner volume of the second tubular member into the first portion of the first inner volume via the first opening. In some embodiments, movement of the medium 109 between the first tubular member and the second tubular member may enable movement of the first magnet through the first portion. Note, in some embodiments, if a gas medium is used, a vent may not be needed or used, in that, the medium gas merely compresses and expands depending upon the position of the first magnet (and bodily fluid pressure).

[0051] In some embodiments, the magnet(s) 103 may be operationally coupled to an electrical circuitry and / or structure, such as sensor 120. In some embodiments, the sensor 120 mayinclude a magnetic force sensor configured to measure the magnetic field of the first magnet and / or the second magnet. In some embodiments, the sensor 120 may include a position sensor configured to measure the position of the first magnet in the first tubular member. In some embodiments, the sensor may be connected to and / or comprises an application specific integrated circuit (ASIC).

[0052] In some embodiments, the implant 100 may further include a communication interface 126 (which may be or include, e.g., an antenna) configured to communicate information between the implant 100 and an external device 130 positioned external to the eye of the patient. In some embodiments, communication interface may be the ASIC or be a component thereof. The implant 100 may include one or more processors 122 operatively coupled to the implant 100 and configured to at least partially process and / or analyze data collected by the sensor 120, and / or send collected data or signals to the external unit via a / the antenna. In some embodiments, the sensor 120 and / or the communication interface 126 may be connected to the processor(s) 122. In some embodiments, the sensor 120 and / or communication interface 126 may be onboard the processor(s) 122. The external device 130 may include a power source 134, one or more processor(s) 132, and a memory 136. In some embodiments, the memory 136 may be configured to store information corresponding to the raw and / or processed sensor data as well as information about the patient (e.g., age, sex, medical history, etc.).

[0053] In some embodiments, the processor(s) 122, 132 can be any suitable processing device(s) configured to run and / or execute a set of instructions or code. For example, the processors 122, 132 can be and / or can include one or more data processors, image processors, graphics processing units (GPU), physics processing units, digital signal processors (DSP), analog signal processors, mixed-signal processors, machine learning processors, deep learning processors, finite state machines (FSM), compression processors (e.g., data compression to reduce data rate and / or memory requirements), encryption processors (e.g., for secure wireless data and / or power transfer), and / or the like. The processors 120, 132 can be, for example, a general-purpose processor, central processing unit (CPU), microprocessor, microcontroller, Field Programmable Gate Array (FPGA), an ASIC (as indicated above), a processor board, a virtual processor, and / or the like. In some embodiments, computations are shared between a field-programmable gate array (FPGA) chip and a microcontroller to optimize for real-time or near real-time operations. The processors 122, 132 can be configured to run and / or execute application processes and / or other modules, processes and / or functions associated with the implant 100. The underlying device technologies may be provided in a variety of componenttypes, for example, metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like generative adversarial network (GAN), polymer technologies (e.g., silicon-conjugated polymer and metal- conjugated polymer-metal structures), mixed analog and digital, and / or the like. In some embodiments, the processor(s) 122, 132 may include an analog-to-digital converter (ADC) to convert the analog (and / or continuous) signals received from implant 100 into a digital signal such that the digital signal can be transmitted to the external device 130. That said, in some embodiments, the collected information regarding the magnet characteristic (e.g., location, field strength) can be analog, and signals sent to the external device can also be analog.

[0054] In some embodiments, the ASIC may include an ADC to convert an analog signal (e.g., from the sensor 120) to a digital signal, and the digital signal may be processed by the microcontroller and wirelessly transmitted to the external device 130 via the communication interface (e.g., the antenna). In some embodiments, the ASIC may be configured for radio frequency energy harvesting. For example, the ASIC may include a component (e.g., the antenna) configured to receive radio-waves at a predetermined frequency and to convert the radio-waves into a direct electrical current that at least momentarily powers the implant 100 (e.g., the ASIC, sensor, and the like), and / or any other components of the implant 100. In some embodiments, the power source 134 of the external device 130 may be configured to transmit radio-waves at the predetermined frequency to the processor(s) 122 (e.g., the ASIC) to power the MEMS (e.g., the sensor 120).

[0055] In some embodiments, the communication interface 126 can be any suitable device(s) and / or interface(s) that can communicate with the components of the implant 100 and the external devices 130. In some embodiments, the communication interface 126 can be configured to communicate information between the implantable device 100 and the processor(s) 132. Moreover, the communication interface 126 can include one or more wireless interfaces.

[0056] In some embodiments, the processor(s) 122 may be configured to receive radio-waves at the predetermined frequency from the power source 134 of the external device 130 to power the electrical circuitry of the implant 100. The radio-waves may be converted into electrical current to power the sensor 120 such that the sensor collects data / signals from the magnet(s) 103 (e.g., position and / or magnetic field strength data). In some embodiments, a processor (which may be included in the ASIC) can be configured to receive data from the sensor 120 and to process that data (e.g., determine the magnitude of the magnetic field, determine themagnitude of the bodily fluid pressure (e.g., intraocular) based on the magnitude of the magnetic field, etc.). In some embodiments, the processor(s) 122 may be configured to receive information from the sensor 120 and optionally the external device 130. In some embodiments, the processor(s) 122 may be configured to partially process the sensor data, then optionally, send the partially processed data to the processor 132 to complete the processing. In some embodiments, signals corresponding to the raw and / or processed sensor data may be sent as radio-waves by the communication interface 126 to the processor 132 of the external device 130. In some embodiments, the processor(s) 122 may be configured to harvest radio-frequency energy, receive data from the sensor 120 optionally the external device 130 corresponding to the magnetic field strength from the processor, process the data received to determine the magnitude of the magnetic field based on the data received, and transmit radio-waves corresponding to the magnetic field and / or the intraocular pressure to the external device 130.

[0057] The system 1000 may enable accurate and convenient monitoring of a bodily fluid in a cavity (a chamber / area of an eye) or vessel (e.g., blood vessel). In some embodiments, the external device 130 may be configured to communicate with one or more additional external devices (e.g., via a remote server) such that a third party (e.g., the patient, a researcher, a medical practitioner) can access information related to the system 1000. The additional external devices may be configured to store information corresponding to the implant 100 and / or the patient. Therefore, the system 1000 may enable monitoring of intraocular pressure of the patient over time. In some embodiments, the memory 136 of the external device 130 can be any suitable memory device(s) configured to store data, information, computer code or instructions (such as those described herein), and / or the like. In some embodiments, the memory 136 can be and / or can include one or more of a random-access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, an erasable programmable readonly memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory 136 can store instructions to cause the processor(s) 122, 132 to execute modules, processes, and / or functions associated with the system 1000, such as models, calculations, or other algorithms to collect and analyze data related to the implant 100 (e.g., the magnetic field strength of the magnet(s) 103) and the eye of the patient (e.g., intraocular fluid).

[0058] FIG. 2A is a diagram of a cross-section of an implant 200 for monitoring intraocular pressure, according to some embodiments. The implant may be configured to be implantedinto, for example, an anterior chamber of an eye of a patient (or a body cavity or vessel). As shown, the implant 200 includes a first tubular member 211 and a second tubular member 205 in fluid communication with one another via a first opening 207. In some embodiments, the first tubular member 211 and the second tubular member 205 are arranged adjacent and / or parallel to one another. The first tubular member 211 and the second tubular member 205 each define an inner volume. In some embodiments, the first tubular member 211 includes a pair of magnets 201, 203 disposed therein. The pair of magnets 201, 203 may be positioned to repel one another such that a repellant force between the pair of magnets 201, 203 increases as the magnets are closer together, and decreases as the magnets are further apart. A first magnet 203 (and in some embodiments, an only magnet) may be configured to move through the inner volume of the first tubular member 211 longitudinally. A second magnet 201 may be affixed to a first end of the first tubular member 211 such that the second magnet 201 is stationary.

[0059] At least a portion of the inner volume of each tubular member 205, 211 can be configured to contain a medium 209. In some embodiments, the inner volume of the first tubular member 211 includes a first portion and a second portion. The medium 209 and one or more of the magnets 201, 203 may be disposed in the first portion, and the second portion may be configured to receive bodily fluid from the cavity or vessel where it is implanted. In some embodiments, a second end of the first tubular member 211 may define an opening 206 through which the bodily fluid from may flow. The first opening 207 may facilitate the movement of the medium 209 (if used) that can fill the inner volume; in the embodiments including two magnets, the medium would fill the space therebetween. In some embodiments, the first tubular member 211 includes a seal 204 disposed therein and configured to separate the first portion of the inner volume from the second portion of the inner volume. In some embodiments, the seal may be configured to help fluidically isolate the first portion of the inner volume from the second portion of the inner volume. As such, the seal 204 fluidically isolates, in embodiment including two magnets, magnets 201, 203 from bodily fluid (e.g., from inside the eye - e.g., the aqueous humor). The seal may be a compliant (e.g., deformable, inflatable, flexible) membrane. The seal 204 may include two characteristics: first, it may be waterproof (e.g., fluid impermeable, impermeable to liquids, and / or impermeable to water or other polar liquids), preventing the fluid from leaking into the space between the fixed and moving magnets. Second, the compliant member can have the ability to expand or contract based on the pressure of the incoming ocular fluid.

[0060] The position of the first magnet 203 relative to the second magnet 201 may depend on both (1) a repulsive force produced by the magnetic fields of the magnets and (2) a force from the bodily fluid being monitored in the second portion of the inner volume of the first tubular member 211. For example, with the implant being used to monitor ocular fluid, as ocular pressure increases, intraocular fluid may enter the second portion of the inner volume of the first tubular member 211 via the second opening 206. As intraocular fluid flows into the second portion, the intraocular fluid may move the seal 204 toward the first end of the first tubular member 211 (e.g., toward the magnets 201, 203). The seal 204 may bend (deform, inflate, expand, etc.) toward the first magnet 203. In some embodiments that include a second magnet, the movement and ultimate position of the first magnet 203 may also depend upon the repulsive magnetic force acting between the magnets. If the force exerted by the ocular fluid on the seal 204 and therefore the first magnet 203 is greater than the repulsive force acting between the magnets 201, 203, then the first magnet will move closer to the second magnet 201, and the distance between the pair of magnets decreases. Conversely, as the intraocular pressure decreases, intraocular fluid may flow out of the second portion of the inner volume via the second opening 206, and the seal 204 may bend (deform, deflate, compress, etc.) toward the second end of the first tubular member 211 (e.g., away from the second magnet 203). If the force exerted by the ocular fluid on the seal 204 and therefore the first magnet 203 is weaker than the repulsive force between the magnets 201, 203, then the first magnet will move away from the second magnet 201, and the distance between the pair of magnets increases. The seal 204 may fluidically isolate the pair of magnets 201, 203 from the intraocular fluid while allowing the first magnet 203 to move through the inner volume of the first tubular member 211.

[0061] The seal may include any suitable material configured to deform and fluidically isolate the first portion of the first inner volume from the second portion of the inner volume. In some embodiments, the seal may include a material including, but not limited to, polyurethane (for example).

[0062] As shown, in some embodiments, a length 214 of the implant 200 may not exceed 10 mm. In some embodiments, the length 214 of the implant 200 may be in a range of about 5 mm to about 10 mm, inclusive of all ranges and subranges therebetween. In some embodiments, a thickness of the implant may not exceed 3 mm. In some embodiments, the thickness of the implant 200 may be in a range of about 1 mm to about 3 mm, inclusive of all ranges and subranges therebetween. In some embodiments, a width 215 of the implant 200 may not exceed3 mm. In some embodiments, the width 215 of the implant 200 may be in a range of about 1 mm to about 3 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the implant 200 may be constructed from a non-magnetizing polymer material (e.g., the tubular members 211, 205 may be formed from a material including the polymer material). In some embodiments, the polymer material may include poly methyl methacrylate (PMMA), which can be both rigid and transparent. In some embodiments, the tubular members 211, 205 may have a circular cross-section (or oval cross-section). In some embodiments, the first tubular member 211 has an inner diameter that is smaller than an inner dimeter of the second tubular member 205. In some embodiments, the inner diameter of the first tubular member 211 is half as large as the inner diameter of the second tubular member 205. In some embodiments, an inner diameter of the second tubular member may not exceed 1 ,5mm, and an inner diameter of the first tubular member 211 may not exceed 0.75mm. In some embodiments, the inner diameter of the first tubular member 211 may be in a range of about 0.40mm to about 1.0mm, inclusive of all ranges and subranges therebetween. In some embodiments, the inner diameter of the second tubular member 205 may be in a range of about 0.80mm to about 2.0mm, inclusive of all ranges and subranges therebetween.

[0063] In some embodiments, one and / or another of the magnets may include a magnetizing material. In some embodiments, one and / or another of the magnets may include any suitable magnetizing or ferromagnetic material including, but not limited to, Neodymium, Cobalt, Alnico, Nickel, Ferrite, Gadolinium, Steel, Iron, Dysprosium, or a suitable combination thereof. In some embodiments, the magnetizing material may include neodymium. In some embodiments, second magnet 201 may be enclosed in a non-magnetizing polymeric material 202 and both the second magnet 201 and the non-magnetizing polymeric material 202 are fixed in place. The first magnet 203 may include the magnetizing material (e.g., neodymium) and may be enclosed in a non-magnetizing hydrophobic polymer 212 which enables the first magnet 203 to smoothly move inside the first tubular member 211. In some embodiments, the non-magnetizing polymer may be any suitable material including, but not limited to, PMMA.

[0064] The implant 200 can be positioned within a bodily fluid cavity or vessel, e.g., inside the eye, such that the second end (e.g., shown on the right side of FIG. 2A), which includes the opening 206, faces the anterior chamber of the eye, allowing the entry of intraocular fluid 210 into the implant 200. As shown, at or near the second end of the implant 200 (e.g., near opening 206), an ASIC integration 208 located outside of tubular members 205, 211. This chip may include a magnetic field sensor and / or b) an Application-specific integrated circuit (ASIC)designed for radio frequency energy harvesting, as well as data processing and transmission. The magnetic field sensor may enable the measurement of the magnetic field strength generated by magnet 203. This measurement varies according to the distance between magnet 203 and magnetic field sensor 208 that is located close to opening 206; when the moving magnet is farther away, the magnetic field weakens, and vice versa.

[0065] FIG. 2B is a schematic diagram of the electronic circuitry coupled to the implant, according to an embodiment. The electronic circuitry configured to receive momentary energy supply (e.g., from the wireless power source 234) for use in measuring the magnetic field strength generated by magnet 203 and converting the energy supply into a continuous electrical signal. This energy is supplied by the ASIC component (not shown), which receives momentary energy supply through a radio frequency energy harvesting-based component that receives radio-waves at a specific frequency and converts them into a direct electrical current that momentarily powers the ASIC and MEMS 224 components thereafter. In response to receiving power from the ASIC, the MEMS 224 may be configured to receive sensor data from the sensor 220.

[0066] In some embodiments, the ASIC component consists of an Analog-Digital Converter (ADC) 221 that converts the analog and continuous signal coming out of the implant (e.g., sensor) into a digital signal. This signal is then processed by a microcontroller 225, and / or transmitted to an external device. The microcontroller 225 can be connected to a transmission system 226 (e.g., the same as or similar to the communication interface 126) with an antenna that wirelessly broadcasts the data to an external receiving device.

[0067] FIG. 3 is an upper plan view of the implant 200 for monitoring intraocular pressure, according to some embodiments. As shown in FIG. 3, the opening 207 is included on a sidewall of the second tubular member 205 (e.g., the sidewall proximate to the first tubular member 211, not shown). The second tubular member includes the medium 209 disposed therein. The electronic circuitry 208 may be coupled to at least a portion of the second tubular member 205 at or near an end of the second tubular member.

[0068] FIG. 4 is a lower plan view of the implant 200, according to some embodiments. As shown, the magnets 201, 203 are disposed in the first portion of the inner volume of the first tubular member 211. The seal 204 separates the magnets 201, 203 and the medium 209 from the second portion of the inner volume. The first tubular member 211 includes the opening 206 at the second end such that intraocular fluid 210 may flow into the second portion of the innervolume. The opening 207 is disposed along a portion of the sidewall of the first tubular member 211 corresponding to the first portion of the inner volume of the first tubular member 211. The electronic circuitry 208 can be coupled at or near the second end of the first tubular member 211.

[0069] FIG. 5 shows the magnet 203 of the implant 200 including a coating 212, according some embodiments. As shown, magnetic material 213 is encapsulated or coated by coating 212 (e.g., a polymeric coating).

[0070] FIG. 6A shows the implant 200 under high intraocular pressure conditions, according to some embodiments. As shown, fluid 210 enters tubular member 211 through opening 206, from the anterior chamber of the eye. This fluid 210 inflates the seal 204 (e.g., the compliant membrane) to an extent dependent on the intraocular pressure within the eye. This inflation exerts a force that pushes the moving magnet 203 (e.g., the first magnet). The fixed magnet 201 (e.g., the second magnet) has an opposite orientation compared to an orientation of magnet 203, thereby generating a repulsive magnetic force between the magnets 201, 203. The magnitude of the magnetic repulsion is dependent on the distance between the two magnets 201, 203. For example, the closer the magnets 201, 203 are to one another, the more powerful the repulsion force. Therefore, two opposing forces act on the moving magnet 203: a force resulting from intraocular pressure (or bodily fluid from a cavity or blood vessel), and a force in the opposite direction resulting from magnetic repulsion with the fixed magnet. The position of the moving magnet in the tube depends on the equilibrium of these forces. Under high intraocular pressure conditions (FIG. 6A), the pushing force of intraocular pressure is greater than the repulsive force between the two magnets, which in some embodiments, cause the seal 204 to deform in a first direction (e.g., enter a first expanded configuration) and magnet 203 to approach the fixed magnet 201. As the magnets 201 and 203 get closer to one another (e.g., the distance between the magnets 201, 203 decreases), the repulsive force between the magnets 201, 203 strengthens. The moving magnet 203 stops at a new position where there is equilibrium between the forces acting on it.

[0071] FIG. 6B shows the implant under low bodily fluid pressure conditions, according to some embodiments. Under low bodily fluid pressure conditions, the pushing force of intraocular pressure is smaller than the repulsive force between the two magnets 201, 203, causing the moving magnet 203 to move away from fixed magnet 201. In some embodiments, the moving magnet 203 moving away from the fixed magnet 201 may cause the seal 204 to return to a rest configuration (e.g., a non-expanded configuration). In some embodiments, themoving magnet 203 moving away from the fixed magnet 201 may cause the seal 204 to deform in a second direction opposite the first direction (e.g., a second expanded configuration). As the magnets 201, 203 move apart, the repulsive force between them weakens. The moving magnet 203 stops at a new position where there is equilibrium between the forces acting on it.

[0072] FIG. 7 is a diagram of the implant 200 showing the opposing forces acting on the moving magnet 203. As shown, the force due to the fluid in the eye (e.g., the force caused by increasing intraocular pressure) acts on the magnet in a first direction (e.g., toward the first end of the tubular member 211, that is, the repulsive magnetic force acting on the magnet 203 in a second opposing direction.

[0073] FIG. 8 is a flowchart of an example method of using a system including an implant to monitor intraocular pressure of a patient, according to some embodiments. While the method is described as using a system with implant 200, it should be appreciated that the method is equally applicable to any system and implant described herein. In some embodiments, the method includes positioning the implant 200 inside an eye of a patient with the opening of the implant facing an anterior chamber of the eye such that ocular fluid flows through the opening into the second portion of the first inner volume, at step 801. In some embodiments, depending upon the intraocular pressure, the ocular fluid can move the movable magnet 203 toward the stationary magnet 201 and move the movable magnet 203 away from the stationary magnet 201 when ocular fluid flows out of the second portion of the first inner volume. In some embodiments, the method may include transmitting radio-waves with a predetermined frequency from an external generator to power the sensor 120. At step 802, the method may include converting the radio-waves provided to the implant 200 by an external generator (e.g., the power source of the external device) into electrical current to power at least the sensor of the electronic circuitry 208. In some embodiments, the method may include measuring a magnetic field strength of the moving magnet 203 using the sensor at step 803. In some embodiments, the magnetic field strength correlated to the distance between the moving magnet 203 and a magnetic field sensor included in the component 208. At step 804, the method may include determining the intraocular pressure of the eye based on the sensed magnetic field strength. The method may further include sending measurements obtained by the sensor to the external device via a communication interface onboard the implant, the external device configured to determine the intraocular pressure. In some embodiments, the information from the implant may be stored on the external device and / or presented to a user via a display of the external device.

[0074] In some embodiments, a method can include receiving at least part of a housing within or adjacent to a bodily fluid cavity or vessel of a patient, wherein the housing includes an inner volume including a second magnet in or adjacent to the inner volume and a first magnet configured to move within the first volume relative to the second magnet based upon the bodily fluid pressure in the cavity or vessel. In some embodiments, at least one of a seal and the second magnet divide the inner volume into a first portion and a second portion; sensing the strength of the magnetic field of the second magnet. The strength of the magnetic field of the first magnet depends upon its position relative to the magnetic field strength sensor. The position of the first magnet may be determined by at least one of bodily fluid flowing into or out of the second portion of the inner volume and a repellant force between the first magnet and the second magnet. The method may further include determining a pressure of the bodily fluid via its correlation to the sensed strength of the magnetic field of the second magnet.

[0075] Similar to other embodiments disclosed herein, FIGs. 9-10B illustrate an intraocular pressure-regulated magnetic drainage system. To this end, FIG. 9 illustrates a diagram of a cross-section of an intraocular pressure-regulated magnetic drainage system 920, according to some embodiments. The intraocular pressure-regulated magnetic drainage system may be configured to be implanted into, for example, an eye (or a body cavity or vessel). As shown, the intraocular pressure-regulated magnetic drainage system 920 includes a first tubular member 921 and a second tubular member 927. The first tubular member 921 and the second tubular member 927 each define an inner volume. The first tubular member 921 leads fluid 930 from a bodily fluid cavity or vessel (for example the anterior chamber of an eye) into the second tubular member 927 and more specifically to the magnetic valve assembly 922. The magnetic valve assembly 922 may be comprised of a first magnet 923 and an opening 924. The opening 924 leads the fluid 930 out of the drainage system when the magnetic valve assembly 922 is open to a drainage site, for example, the subconjunctival space of an eye. The second tubular member 927 can include a pair of magnets 923, 925 disposed therein. In some embodiments, the second tubular member may be at least partially filled with a non-magnetizing material 926 such as PMMA. The pair of magnets 923, 925 may be positioned to repel one another such that a repellant force between the pair of magnets 923, 925 increases as the magnets are closer together, and decreases as the magnets are further apart. A first magnet 923 (and in some embodiments, an only magnet) may be configured to move through the inner volume of the second tubular member 927 longitudinally. A second magnet 925 may be affixed to a first end of the second tubular member 927 such that the second magnet 925 is stationary.

[0076] The opening of the valve according to a threshold pressure (e.g., IOP), which can be referred to as a valve opening pressure, depends upon the distance between the two repulsive magnets. The closer the distance, the higher the pressure threshold.

[0077] FIG. 10A shows the intraocular pressure-regulated magnetic drainage system 920 under high intraocular pressure conditions, according to some embodiments. As shown, fluid 930 enters a first tubular member 921 from the bodily fluid cavity or vessel (e.g., the anterior chamber of an eye or first chamber of the eye). The fluid volume 930 entering the first tubular member 921 exerts a force on the magnet 923 pushing it in a first direction (e.g., towards the second magnet 925). The second magnet 925 exerts a magnetic repulsive force on the first magnet 923 due to its opposite magnetic pole orientation. The magnitude of the magnetic repulsion depends on the distance between the two magnets 923, 925. For example, the closer the magnets 923, 925 are to one another, the more powerful the repulsion force. Therefore, two opposing forces act on the first magnet 923 : a force resulting from intraocular pressure (or bodily fluid from a cavity or blood vessel), and a force in the opposite direction resulting from magnetic repulsion with the second magnet 925. The position of the first magnet 923 in the second tubular member 927 depends on the equilibrium of these forces. Under high intraocular pressure conditions (FIG. 10A), the fluid volume 930 entering the first tubular member 921 exerts a force on the first magnet 923 that is higher than the repulsive force acting between the two magnets 923 and 925, pushing the first magnet 923 in a first direction towards the second magnet 925 and moving the magnetic valve assembly 922 to an open state. Under this open state, the fluid 930 flows through an opening 924 towards a drainage site, such as the subconjunctival space of an eye. The opening can also be referred to as a conduit, and in some embodiments, may include a length and a diameter.

[0078] As the magnets 923 and 925 get closer to one another (i.e., the distance between the magnets 223, 225 decreases), the repulsive force between the magnets 923, 925 increases. The first magnet 923 stops at a new position where there is an equilibrium between the forces acting on it.

[0079] FIG. 10B shows the intraocular pressure-regulated magnetic drainage system under low bodily fluid pressure conditions, according to some embodiments. Under low bodily fluid pressure conditions, the force exerted on the first magnet 923 by the fluid volume 930 entering the magnetic valve assembly 922 is smaller than the repulsive force acting between the two magnets 923 and 925. Under the new force conditions acting on the first magnet 923, it moves in a second direction away from the second magnet 925, turning the magnetic valve assembly922 back to a closed state. Under the closed state condition, the fluid 930 do not have access to flow through the opening 924 backwards from a drainage site, such as the subconjunctival space of an eye.

[0080] As the magnets 923 and 925 move apart, the repulsive force acting between them weakens. The first magnet 923 now stops at a new position where there is equilibrium between the forces acting on it.

[0081] The following chart illustrates exemplary embodiments for any of the disclosed embodiments which use repulsive magnetic force between two magnets to open a conduit, passage, or valve, regarding a type of magnet, the magnet diameter and length, and a distance between the magnets, and associated threshold fluid pressure (P).Examples of Some of the Embodiments of the disclosureExample 1. A bodily fluid pressure monitoring method including implanting at least part of a housing of a bodily-fluid pressure sensing device (PSD) within or adjacent to a fluid-containing cavity or vessel, where the housing includes an inner volume divided into a first portion and a second portion by a first magnet, and where the second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon apressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume; sensing a characteristic of the first magnet based on the position of the first magnet within the inner volume, where: the position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, and the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel; and determining the pressure of the bodily fluid within the cavity or vessel based on the sensed characteristic of the first magnet.Example 2. The method of example 1, where the housing includes a second magnet.Example 3. The method of example 2, where the second magnet is arranged within the first portion of the inner volume.Example 4. The method of any of examples 2-3, where like poles of each of the first magnet and the second magnet are arranged such the first and second magnets face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.Example 5. The method of any of examples 1-4, where the characteristic is magnetic field, and the sensor includes a magnetic field sensor.Example 6. The method of example 5, where the magnetic field sensor is arranged at a first location on or adjacent the housing.Example 7. The method of any of examples 5-6, where the PSD corresponds to a microelectromechanical system (MEMS).Example 8. The method of any of examples 5-7, where the magnetic field sensor is configured to sense a magnetic field strength.Example 9. The method of any of examples 5-8, where the strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel.Example 10. The method of any of examples 5-9, where the sensed strength of the magnetic field of the first magnet depends on its location relative to the magnetic field sensor.Example 11. The method of any of examples 6-9, where the sensed strength of the magnetic field of the first magnet depends on its location relative to the first location.Example 12. The method of any of examples 2-11, where the positions of the first magnet within the inner volume is additionally determined by a / the repulsive force generated between the first magnet and the second magnet.Example 13. The method of any of examples 1-12, where the first portion of the inner volume includes a medium or structure to retain or aid in retaining the first magnet at a particular position within the inner volume.Example 14. The method of any of examples 1-13, where the housing includes any geometric shape including a tubular structure.Example 15. The method of any of examples 1-14, where the housing includes a vent configured to vent the first portion.Example 16. The method of example 15, where the vent is configured to allow a / the medium contained within first portion to flow in and / or out of the vent.Example 17. The method of any examples 1-16, further includes a second housing, the second housing optionally comprises any geometric shape including a tubular shape.Example 18. The method of example 17, where the second housing including a second inner volume is configured to allow a / the medium from the first portion to flow into and / or out of the second inner volume via a / the vent.Example 19. The method of any of examples 1-18, further includes a seal.Example 20. The method of any of examples 1-18, where the first magnet includes a seal.Example 21. The method of any of examples 1-20, further includes at least one of receiving and transmitting radio-frequency (RF) signals.Example 22. The method of any of examples 1-21, where the housing includes or is arranged adjacent to an application-specific-integrated-chip (ASIC).Example 23. The method of any of examples 5-22, where the magnetic field sensor is a component of an / the application-specific-integrated-chip (ASIC).Example 24. The method of example 22, where the RF signals are received and / or transmitted via the ASIC.Example 25. The method of any of examples 22-24, where at least one of the housing and the ASIC include an antenna for ultimately receiving and / or transmitting RF signals.Example 26. The method of any of examples 22-25, where the bodily fluid pressure within the cavity or vessel is determined by at least one of the ASIC and an external device.Example 27. The method of any of examples 21-26, further includes transmitting the determined bodily fluid pressure via RF signals.Example 28. The method of any of examples 1-27, further includes harvesting energy from RF-signals transmitted to the PSD, the energy used to power the PSD.Example 29. The method of examples 27, where harvesting energy is accomplished by a / the ASIC.Example 30. The method of any of examples 1-29, where the PSD is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the PDS and instructing the PSD to determine and / or transmit the characteristic of the first magnet.Example 31. The method of example 29, where the external device determines the bodily fluid pressure within the cavity or vessel based on the transmitted characteristic.Example 32. The method of any of examples 1-31, where at least one of the first magnet and a / the second magnet is neodymium.Example 33. The method of any of examples 1-32, where at least one of the housing and a / the second housing includes a biocompatible non-magnetizing material.Example 34. The method of example 33, where the non-magnetizing material is a polymer.Example 35. The method of any of examples 1-34, where at least one of the first magnet and a / the second magnet are each enclosed in a biocompatible non-magnetizing material.Example 36. The method of example 35, where the non-magnetizing material is a polymer which may be PMMA.Example 37. The method of any of examples 33-36, where the non-magnetizing material is hydrophobic.Example 38. The method of any of examples 5-37, where the magnetic field sensor provides one or more signals corresponding the sensed magnetic fields of the first magnet.Example 39. The method of any of examples 7-38, where the PSD further includes an analog- to-digital converter (ADC) configured to convert analog signals from the MEMS into a digital signal.Example 40. The method of example 39, where the ADC is part of a / the application-specific- integrated-chip (ASIC).Example 41. The methods of any of examples 1-40, where a thickness of the PSD does not exceed 3 mm;Example 42. The method of any of examples 1-41, where a length of the PSD does not exceed10 mm.Example 43. The method of any of examples 1-42, where a width of the PSD does not exceed3 mm.Example 44. The method of any of examples 17-43, where the first housing and the second housing are arranged parallel to one another.Example 45. The method of any of examples 17-44, where an inner diameter of the second housing is greater than an inner diameter of the first housing.Example 46. The method of any of examples 17-45, where the inner diameter of the second housing is at least twice the size of the inner diameter of the first housing.Example 47. The method of any of examples 17-46, where the inner diameter of the first housing does not exceed 0.80 mm and the inner diameter of the second housing does not exceed 1.5 mm.Example 48. The method of any of examples 17-47, where the inner diameter of the second housing is configured such that compression of the medium in the first housing is less than 2mm.Example 49. The method of any of examples 1-48, such that as the bodily fluid flows into the second portion of the first inner volume causing the first magnet to move in a first direction away from the opening.Example 50. The method of any of examples 1-49, such that as the bodily fluid flows out from the second portion of the inner volume causing the first magnet to move in a second direction towards the opening.Example 51. The method of any of examples 1-50, where bodily fluid flows into the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel increases and flows out of the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel decreases.Example 52. The method of any of examples 2-51, where the distance between the first magnet and the second magnet depends on an equilibrium between the repellant force between the first magnet and second magnet and a force applied on the first magnet by a volume of bodily fluid flowing into the second portion of the inner volume.Example 53. The method of any of examples 1-52, where the bodily fluid is ocular fluid and the cavity is at least a portion of a segment or chamber of an eye of the patient.Example 54. The method of any of examples 1-53, where the bodily fluid is ocular fluid and the cavity is at least a portion of the anterior segment of an eye of the patient.Example 55. A bodily fluid pressure monitoring device including a housing, at least a portion of which is configured for implantation within or adjacent to a fluid-containing cavity or vessel, where the housing includes an inner volume divided into a first portion and a second portion by a first magnet, where the second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon a pressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume; a sensor configured to sense a characteristic of the first magnet based on the position of the first magnet within the inner volume, where the position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel; and the pressure of the bodily fluid within the cavity or vessel is determined based on the sensed characteristic of the first magnet.Example 56. The device of example 55, where the housing includes a second magnet.Example 57. The device of example 56, where the second magnet is arranged within the first portion of the inner volume.Example 58. The device of any of examples 55-57, where like poles of each of the first magnet and the second magnet are arranged such that the first and second magnets face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.Example 59. The device of any of examples 55-58, where the characteristic is magnetic field, and the sensor includes a magnetic field sensor.Example 60. The device of example 59, where the magnetic field sensor is arranged at a first location on or adjacent the housing.Example 61. The device of any of examples 59-60, where the device corresponds to a microelectromechanical system (MEMS).Example 62. The device of any of examples 59-61, where the magnetic field sensor is configured to sense a magnetic field strength.Example 63. The device of any of examples 59-62, where the sensed strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel.Example 64. The device of any of examples 59-63, where the sensed strength of the magnetic field of the first magnet depends on its location relative to magnetic field sensor.Example 65. The device of any of examples 59-63, where the sensed strength of the magnetic field of the first magnet depends on its location relative to the first location.Example 66. The device of any of examples 56-65, where the positions of the first magnet within the inner volume is additionally determined by a / the repulsive generated between the first magnet and the second magnet.Example 67. The device of any of examples 55-66, where the first portion of the inner volume includes a medium or structure to retain or aid in retaining the first magnet at a particular position within the inner volume.Example 68. The device of any of examples 55-67, where the housing corresponds to a tubular structure.Example 69. The device of any of examples 55-68, where the housing includes a vent configured to vent the first portion.Example 70. The device of example 69, where the vent is configured to allow a / the medium contained within first portion to flow in and / or out of the vent.Example 71. The device of any of examples 55-70, further includes a second housing.Example 72. The device of example 71, where the second housing including a second inner volume is configured to allow a / the medium from the first portion to flow into and / or out of the second inner volume via a / the vent.Example 73. The device of any of examples 55-72, further includes a seal.Example 74. The device of any of examples 55-72, where the first magnet includes a seal.Example 75. The device of any of examples 55-74, further includes at least one of receiving and transmitting radio-frequency (RF) signals.Example 76. The device of any of examples 55-75, where the housing includes or is arranged adjacent to an application-specific-integrated-chip (ASIC), and where optionally, the ASIC includes a determination means for determining the pressure of the bodily fluid within the cavity or vessel based on the sensed characteristic of the first magnet;Example 77. The device of any of examples 59-76, where the magnetic field sensor is a component of an / the application-specific-integrated-chip (ASIC).Example 78. The device of example 77, where the RF signals are received and / or transmitted via the ASIC.Example 79. The device of any of examples 77-78, where at least one of the housing and the ASIC include an antenna for ultimately receiving and / or transmitting RF signals.Example 80. The device of any of examples 77-79, where the bodily fluid pressure within the cavity or vessel is determined by the ASIC.Example 81. The device of any of examples 79-80, further includes transmitting the determined bodily fluid pressure via RF signals.Example 82. The device of any of examples 55-81, further includes harvesting energy from RF-signals transmitted to the device, the energy used to power the device.Example 83. The device of example 82, where harvesting energy is accomplished by a / the ASIC.Example 84. The device of any of examples 55-83, where the device is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the device and instruct the device to determine the bodily fluid pressure within the cavity or vessel to which the device is implanted.Example 85. The device of any of examples 55-84, where at least one of the first magnet and a / the second magnet is neodymium.Example 86. The device of any of examples 55-85, where at least one of the housing and a / the second housing includes a biocompatible non-magnetizing material.Example 87. The device of example 86, where the non-magnetizing material is a polymer.Example 88. The device of any of examples 56-87, where at least one of the first magnet and a / the second magnet are each enclosed in a biocompatible non-magnetizing material.Example 89. The device of example 88, where the non-magnetizing material is a polymer which may be PMMA.Example 90. The device of any of examples 86-89, where the non-magnetizing material is hydrophobic.Example 91. The device of any of examples 61-90, where the ASIC transmits one or more signals corresponding the sensed magnetic field of the first magnet.Example 92. The device of any of examples 61-91, where the device further includes an analog-to-digital converter (ADC) configured to convert analog signals from the MEMS into a digital signal.Example 93. The device of example 92, where the device is part of a / the application-specific- integrated-chip (ASIC).Example 94. The devices of any of examples 55-93, where a thickness of the device does not exceed 3 mm.Example 95. The device of any of examples 55-94, where a length of the device does not exceed 10 mm.Example 96. The device of any of examples 55-95, where a width of the device does not exceed 3 mm.Example 97. The device of any of examples 71-96, where the first housing and the second housing are arranged parallel to one another.Example 98. The device of any of examples 71-97, where an inner diameter of the second housing is greater than an inner diameter of the first housing.Example 99. The device of any of examples 71-98, where the inner diameter of the second housing is at least twice the size of the inner diameter of the first housing.Example 100. The device of any of examples 71-99, where the inner diameter of the first housing does not exceed 0.80 mm and the inner diameter of the second housing does not exceed 1.5 mm.Example 101. The device of any of examples 55-100, where the inner diameter of the first housing does not exceed 0.80 mm and the inner diameter of the second housing does not exceed 1.5 mm.Example 102. The device of any of examples 71-101, where the inner diameter of the second housing is configured such that compression of the medium in the first housing is less than 2mm.Example 103. The device of any of examples 55-102, s as the bodily fluid flows into the second portion of the first inner volume causing the first magnet to move in a first direction away from the opening.Example 104. The device of any of examples 55-102, such that bodily fluid flows out from the second portion of the inner volume causing the first magnet to move in a second direction towards the opening.Example 105. The device of any of examples 55-104, where bodily fluid flows into the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel increases and flows out of the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel decreases.Example 106. The device of any of examples 56-105, where the distance between the first magnet and the second magnet depends on an equilibrium between the repellant force between the first magnet and second magnet and a force applied on the first magnet by a volume of bodily fluid flowing into the second portion of the inner volume.Example 107. The device of any of examples 55-106, where the bodily fluid is ocular fluid and the cavity is at least a portion of a segment or a chamber of an eye of the patient.Example 108. A bodily fluid pressure monitoring system including a device according to any of examples 55-107 and an external unit configured for any of communication and supplying power to the device, as well as a / the determination means for determining the pressure within the fluid containing cavity or vessel.Example 109. The system of example 108, where the determination means includes a processor.Example 110. The system of examples 108 or 109, where the determination means includes an application-specific-integrated-chip (ASIC).Example 111. The system of any of examples 108-110, where the external unit is configured to at least one of transmission of RF-signals at a predetermined frequency to a / the ASIC and receive data transmitted via RF-signals by the device.Example 112. The system of example 111, where the external unit includes a memory configured to store data and a display for displaying information to a user.Example 113. A method for dynamically regulating fluid outflow in response to intraocular pressure (IOP) fluctuations.Example 114. The method of example 113, where the method includes magnetically controlling a valve that opens when IOP exceeds a predefined threshold.Example 115. The method of example 114, where magnetically controlling the valve includes closing the valve upon normalization of the IOP.Example 116. The method of any of examples 113-115, where dynamically regulating fluid outflow and / or controlling the valve is performed without the need of a stand-alone power source.Example 117. The method of any of examples 113-116, where the method results in a minimization of a risk of hypotony by preventing excessive drainage when the IOP is within a physiological range.Example 118. An implantable pressure regulating device for regulating a bodily fluid within a body vessel or bodily area, the device including a biocompatible housing including a size, shape, and material for seamless integration with or within tissue while minimizing an inflammatory response thereof, the biocompatible housing including a first chamber; a conduit that connects the first chamber to a drainage site; and a pressure-sensitive magnetic valve (PSMV) assembly positioned within or adjacent to the conduit, the PSMV configured for selective fluid flow based on one or more lOPs, the magnetic valve including a first magnet arranged so as to respond to an IOP level to modulate an open and a closed state of the valve; and a second magnet arranged with respect to the first magnet such that like poles of each of the first magnet and the second magnet face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.Example 119. The device of example 118, where the drainage site corresponds to the subconjunctival space of an eye to which the device is implanted.Example 120. The device of example 118 or 119, where the PSMV is configured to open when the pressure of the bodily fluid exceeds a predefined threshold and is configured to close when pressure is below the threshold.Example 121. The device of any of examples 118-120, where each magnetic is a ferromagnetic component configured to maintain a closed state under normal bodily fluid pressure conditions and an open state under an elevated pressure state.Example 122. The device of any of examples 120-121, further includes a threshold adjustability mechanism configured to adjust the predefined pressure threshold.Example 123. The device of example 122, where the threshold adjustability mechanism includes the second magnet or an additional magnet.Example 124. The device of any of examples 118-123, where like poles of each of the first magnet and the second magnet are arranged such that the first and second magnets face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.Example 125. The device of any of examples 118-124, where the open and closed states of the magnetic valve assembly depends on the position of the first magnet.Example 126. The device of any of examples 118-125, where a position of the first magnet is determined by the pressure of the bodily fluid within the vessel or bodily area.Example 127. The device of any of examples 118-126, further includes a sensor configured to sense a characteristic of the first magnet based on the position of the first magnet within the first chamber.Example 128. The device of example 127, where the position of the first magnet within the first chamber is determined by the pressure of the bodily fluid within the cavity or vessel.Example 129. The device of any of examples 127 and 128, where the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel.Example 130. The device of any of examples 127-129, where the pressure of the bodily fluid within the cavity or vessel is determined based on the sensed characteristic of the first magnet.Example 131. The device of any of examples 127-130, where the characteristic is magnetic field, and the sensor comprises a magnetic field sensor.Example 132. The device of example 131, where the magnetic field sensor is arranged at a first location on or adjacent the housing.Example 133. The device of any of examples 118-132, where the device corresponds to a micro-electromechanical system (MEMS).Example 134. The device of any of examples 131-133, where the magnetic field sensor is configured to sense a magnetic field strength.Example 135. The device of any of examples 131-134, where the sensed strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel.Example 136. The device of any of examples 131-135, where the sensed strength of the magnetic field of the first magnet depends on its location relative to magnetic field sensor.Example 137. The device of any of examples 131-136, where the sensed strength of the magnetic field of the first magnet depends on its location relative to the first location.Example 138. The device of any of examples 118-137, where the positions of the first magnet within the inner volume is additionally determined by a / the repulsive generated between the first magnet and the second magnet.Example 139. The device of any of examples 118-138, where the first portion of the first chamber includes a medium or structure to retain or aid in retaining the first magnet at a particular position within the inner volume.Example 140. The device of any of examples 118-139, where the housing corresponds to a tubular structure.Example 141. The device of any of examples 118-140, further includes a second housing.Example 142. The device of example 141, where the second housing including a second chamber configured to allow a / the medium from the first portion to flow into and / or out of the second inner volume via the conduit.Example 143. The device of any of examples 118-142, further includes a seal.Example 144. The device of any of examples 118-143, where the first magnet includes a seal.Example 145. The device of any of examples 118-144, further includes at least one of receiving and transmitting radio-frequency (RF) signals.Example 146. The device of any of examples 118-145, where the housing includes or is arranged adjacent to an application-specific-integrated-chip (ASIC), and where optionally, the ASIC includes a determination means for determining the pressure of the bodily fluid within the cavity or vessel based on the sensed characteristic of the first magnet.Example 147. The device of any of examples 131-146, where the magnetic field sensor is a component of an / the application-specific-integrated-chip (ASIC).Example 148. The device of example 147, where the RF signals are received and / or transmitted via the ASIC.Example 149. The device of any of examples 147-148, where at least one of the housing and the ASIC include an antenna for ultimately receiving and / or transmitting RF signals.Example 150. The device of any of examples 147-149, where the bodily fluid pressure within the cavity or vessel is determined by the ASIC.Example 151. The device of any of examples 149-150, further includes transmitting the determined bodily fluid pressure via RF signals.Example 152. The device of any of examples 118-151, further includes harvesting energy from RF-signals transmitted to the device, the energy used to power the device.Example 153. The device of example 152, where harvesting energy is accomplished by a / the ASIC.Example 154. The device of any of examples 118-153, where the device is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the device and instruct the device to determine the bodily fluid pressure within the cavity or vessel to which the device is implanted.Example 155. The device of any of examples 118-154, where at least one of the first magnet and a / the second magnet is neodymium.Example 156. The device of any of examples 118-155, where at least one of the housing and a / the second housing includes a biocompatible non-magnetizing material.Example 157. The device of example 156, where the non-magnetizing material is a polymer.Example 158. The device of any of examples 156-157, where at least one of the first magnet and a / the second magnet are each enclosed in a biocompatible non-magnetizing material.Example 159. The device of example 158, where the non-magnetizing material is a polymer which may be PMMA.Example 160. The device of any of examples 156-159, where the non-magnetizing material is hydrophobic.Example 161. The device of any of examples 153-160, where the ASIC transmits one or more signals corresponding the sensed magnetic field of the first magnet.Example 162. The device of any of examples 153-161, where the device further includes an analog-to-digital converter (ADC) configured to convert analog signals from the MEMS into a digital signal.Example 163. The device of example 162, where the device is part of a / the application- specific-integrated-chip (ASIC).Example 164. The devices of any of examples 118-163, where a thickness of the device does not exceed 3 mm.Example 165. The device of any of examples 118-164, where a length of the device does not exceed 10 mm.Example 166. The device of any of examples 118-165, where a width of the device does not exceed 3 mm.Example 167. The device of any of examples 141-166, where the first housing and the second housing are arranged parallel to one another.Example 168. The device of any of examples 141-167, where an inner diameter of the second housing is greater than an inner diameter of the first housing.Example 169. The device of any of examples 141-168, where the inner diameter of the second housing is at least twice the size of the inner diameter of the first housing.Example 170. The device of any of examples 141-169, where the inner diameter of the first housing does not exceed 0.80 mm and the inner diameter of the second housing does not exceed 1.5 mm.Example 171. The device of any of examples 118-100, where the inner diameter of the first housing does not exceed 0.80 mm and the inner diameter of the second housing does not exceed 1.5 mm.Example 172. The device of any of examples 141-171, where the inner diameter of the second housing is configured such that compression of the medium in the first housing is less than 2mm.Example 173. The device of any of examples 118-172, such that as the bodily fluid flows into the second portion of the first inner volume causing the first magnet to move in a first direction away from the opening.Example 174. The device of any of examples 118-173, such that as the bodily fluid flows out from the second portion of the inner volume causing the first magnet to move in a second direction towards the opening.Example 175. The device of any of examples 118-174, where bodily fluid flows into the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel increases and flows out of the second portion of the inner volume when the bodily fluid pressure within the cavity or vessel decreases.Example 176. The device of any of examples 119-175, where the distance between the first magnet and the second magnet depends on an equilibrium between the repellant force between the first magnet and second magnet and a force applied on the first magnet by a volume of bodily fluid flowing into the second portion of the inner volume.Example 177. The device of any of examples 118-176, where the bodily fluid is ocular fluid and the cavity is at least a portion of a segment or a chamber of an eye of the patient.Example 178. A movable magnetic device operatively coupled to a valve to modulate fluid passage based on pressure variations.Example 179. The device of example 178, further including one and / or another of (and in some embodiments, if not mutually exclusive, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the features, functionality, steps, structure, and clarifications of any of examples 1-177.Example 180. The method, device, and / or system of any of examples 1-179, where, in the case of at least two magnets, like poles of each of the first magnet and the second magnet are arranged such that they face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet; repulsive force(s) counterbalances intraocular pressure (IOP) fluctuations; one or more (preferably all) of magnets used in at least some embodiments are high-grade neodymium N52 magnets (although alternative magnet types with comparableforce characteristics may also be used); generated repulsive force(s) is configured to oppose pressure exerted by a fluid volume within the IOP range of 0-30 mmHg; and / or generated repulsive force(s) can be achieved by configuring at least one of (and preferably a plurality of, and more preferably all of) the magnetic field strength, polarity, and spatial arrangement, to produce a controlled repulsive force(s) that correlates with the hydrostatic pressure acting on the implant / device, the force(s) output is tunable based on at least one of (and preferably a plurality of, and more preferably, all of) magnet selection, geometry, and separation distance, allowing adaptability for various clinical applications.Example 181. The method, device, and / or system of any of examples 1-179, where an / the opening of a / the valve is according to a threshold pressure (e.g., IOP), which can be referred to as a valve opening pressure, depends upon the distance between the two repulsive magnets. The closer the distance, the higher the pressure threshold.General Considerations

[0082] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that any and all parameters, dimensions, materials, and configurations described herein are meant to be an example and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the inventive teachings disclosed herein is / are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the claims supported by the disclosure, and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are also directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope ofthe present disclosure (thus, such two or more features can be inventive embodiments that can be claimed).

[0083] The various embodiments described and / or illustrated herein may also be combined together, and / or, combined with one or more features, as well as complete systems, devices and / or methods, to yield yet other embodiments and inventions. Moreover, some embodiments, may be distinguishable from the prior art by specifically lacking one and / or another feature disclosed in the particular prior art reference(s); i.e., claims to such embodiments are distinguishable from the prior art by including one or more negative limitations so as to be patentable based on lacking such feature(s).

[0084] As noted above, various inventive concepts may be embodied as one or more methods. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously.

[0085] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The terms “can” and “may” are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to) for a particular embodiment s).

[0086] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0087] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0088] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0089] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

What is currently claimed:

1. A bodily fluid pressure monitoring method comprising: implanting at least part of a housing of a bodily-fluid pressure sensing device (PSD) within or adjacent to a fluid-containing cavity or vessel, wherein the housing includes an inner volume divided into a first portion and a second portion by a first magnet, and wherein: the second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon a pressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume; sensing a characteristic of the first magnet based on the position of the first magnet within the inner volume, wherein: the position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, and the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel; and determining the pressure of the bodily fluid within the cavity or vessel based on the sensed characteristic of the first magnet.

2. The method of claim 1, wherein the characteristic is magnetic field, and the sensor comprises a magnetic field sensor.

3. The method of claim 2, wherein the PSD comprises a micro-electromechanical system (MEMS).

4. The method of claim 2, wherein the sensed strength of the magnetic field of the first magnet depends on its location relative to the magnetic field sensor.

5. The method of claim 2, wherein the positions of the first magnet within the inner volume is additionally determined by a / the repulsive force generated between the first magnet and the second magnet.

6. The method of claim 2, further comprising at least one of receiving and transmitting radio-frequency (RF) signals.

7. The method of claim 1, further comprising harvesting energy from RF-signals transmitted to the PSD, the energy used to power the PSD.

8. The method of claim 1, wherein the PSD is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the PDS and instructing the PSD to determine and / or transmit the characteristic of the first magnet.

9. A bodily fluid pressure monitoring device comprising: a housing, at least a portion of which is configured for implantation within or adjacent to a fluid-containing cavity or vessel, wherein the housing includes an inner volume divided into a first portion and a second portion by a first magnet, wherein: the second portion includes a bodily fluid opening for allowing the bodily fluid to flow into and out of the second portion depending upon a pressure of the bodily fluid within the cavity or vessel, and the flow of bodily fluid into and out of the opening is configured to move the first magnet within the inner volume; a sensor configured to sense a characteristic of the first magnet based on the position of the first magnet within the inner volume, wherein:the position of the first magnet within the inner volume determined by the pressure of the bodily fluid within the cavity or vessel, the characteristic is correlated to the pressure of the bodily fluid within the cavity or vessel; and the pressure of the bodily fluid within the cavity or vessel is determined based on the sensed characteristic of the first magnet.

10. The device of claim 9, wherein the characteristic is magnetic field, and the sensor comprises a magnetic field sensor.

11. The device of claim 10, wherein the device comprises a micro-electromechanical system (MEMS).

12. The device of claim 10, wherein the sensed strength of the magnetic field of the first magnet correlates to a particular bodily fluid pressure of the bodily fluid within the cavity or vessel.

13. The device of claim 9, wherein the positions of the first magnet within the inner volume is additionally determined by a / the repulsive generated between the first magnet and a second magnet.

14. The device of claim 9, further comprising at least one of receiving and transmitting radio-frequency (RF) signals.

15. The device of claim 9, further comprising harvesting energy from RF-signals transmitted to the device, the energy used to power the device.

16. The device of claim 9, wherein the device is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the device and instruct the device to determine the bodily fluid pressure within the cavity or vessel to which the device is implanted.

17. A bodily fluid pressure monitoring system comprising: a device according to any of claims 9-16; and an external unit configured for any of communication and supplying power to the device, as well as a / the determination means for determining the pressure within the fluid containing cavity or vessel.

18. The system of claim 17, wherein the external unit is configured to at least one of transmission of RF-signals at a predetermined frequency to a / the ASIC and receive data transmitted via RF-signals by the device.

19. A method for dynamically regulating fluid outflow in response to intraocular pressure (IOP) fluctuations.

20. The method of claim 19, wherein the method comprises magnetically controlling a valve that opens when IOP exceeds a predefined threshold.

21. The method of claim 19, wherein dynamically regulating fluid outflow and / or controlling the valve is performed without the need of a stand-alone power source.

22. An implantable pressure regulating device for regulating a bodily fluid within a body vessel or bodily area, the device comprising:a biocompatible housing including a size, shape, and material for seamless integration with or within tissue while minimizing an inflammatory response thereof, the biocompatible housing including a first chamber; a conduit that connects the first chamber to a drainage site; and a pressure-sensitive magnetic valve (PSMV) assembly positioned within or adjacent to the conduit, the PSMV configured for selective fluid flow based on one or more lOPs, the magnetic valve comprising: a first magnet arranged so as to respond to an IOP level to modulate an open and a closed state of the valve; and a second magnet arranged with respect to the first magnet such that like poles of each of the first magnet and the second magnet face one another so as to generate a repulsive magnetic force between the first magnet and the second magnet.

23. The device of claim 22, wherein the PSMV is configured to open when the pressure of the bodily fluid exceeds a predefined threshold and is configured to close when pressure is below the threshold.

24. The device of claim 23, further comprising a threshold adjustability mechanism configured to adjust the predefined pressure threshold.

25. The device of claim 22, further comprising a sensor configured to sense a characteristic of the first magnet based on the position of the first magnet within the first chamber.

26. The device of claim 25, wherein the characteristic is magnetic field, and the sensor comprises a magnetic field sensor.

27. The device of claim 22, further comprising harvesting energy from RF-signals transmitted to the device, the energy used to power the device.

28. The device of claim 22, wherein the device is configured to receive RF-signals transmitted from an external device, the RF-signals providing at least one of energy to power the device and instruct the device to determine the bodily fluid pressure within the cavity or vessel to which the device is implanted.

29. The device of claim 22, wherein at least one of the first magnet and a / the second magnet comprises neodymium.

30. A movable magnetic device operatively coupled to a valve to modulate fluid passage based on pressure variations within a vessel or a cavity of a human body.

31. A device, apparatus, system or method according to any of the disclosed embodiments.

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