Medical devices with physiological sensors

Abstract

A medical device can include a fluid chamber configured to contain fluid, a plunger comprising a stopper and configured to be moveable within the fluid chamber, and a pressure sensor disposed at least partially within the plunger such that the pressure sensor is in fluid communication with the fluid chamber. The device also includes a calibration sensor configured to generate calibration data and a controller in electrical communication with the pressure sensor. The controller is configured to receive pressure data from the pressure sensor while the fluid chamber is in fluid communication with the interior of a patient, receive calibration data from the calibration sensor, generate a pressure reading based on the pressure data and calibration data, transmit the pressure reading to a display interface, and cause the display interface to display the pressure based on the pressure reading.

Description

MEDICAL DEVICES WITH PHYSIOLOGICAL SENSORSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 574,685, entitled “MEDICAL DEVICES WITH PHYSIOLOGICAL SENSORS”, and filed April 4, 2024, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.TECHNICAL FIELD

[0002] Implementations of the present disclosure relate to systems and techniques for monitoring and measuring physiological parameters during medical procedures. More specifically, implementations of the present disclosure relate to devices and methods for real-time pressure monitoring within patient tissue.BACKGROUND

[0003] Physiological parameters associated with a patient tissue can be valuable at supporting and promoting the health of the patient. One type of physiological parameters includes pressure measurements. For example, intraocular pressure (IOP) measurements can be valuable for patients by helping practitioners pressurizing or repressurizing the patient’s eye to a physiologically appropriate level. Cataract surgery, a prevalent procedure necessary for restoring vision impaired by lens opacification, requires precise TOP management to ensure successful outcomes and avoid postoperative complications like astigmatism or vision loss. Current IOP measurement techniques, such as tonometry, are often impractical during surgery due to their invasive nature, risk of exacerbating surgical incisions, and disruption to the surgical workflow. Additionally, reliance on subjective methods, like tactile assessment, introduces variability and potential inaccuracies into the surgical process. There is a need for an integrated solution that allows for continuous, accurate physiological parameter (e.g., IOP) monitoring, which may prevent interruptions to various surgical processes, thereby enhancing patient safety, improving patient outcomes, reducing the risk of postoperative complications, among many other benefits.SUMMARY

[0004] The systems, methods, and devices described herein each have several aspects, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this disclosure, several non-limiting features will now be described briefly.

[0005] In some embodiments, an insertion ophthalmic device is described. This device includes a coupling unit with a fluid channel that can be releasably connected to a syringe’s fluid outlet, facilitating fluid flow. A display interface on the device shows intraocular pressure (IOP) readings. The sensing unit, attached to the coupling unit, includes a pressure sensor in fluid communication with the fluid channel. This sensor can detect pressures between 0 and 100 mmHg and generate a signal reflecting the IOP relative to the external environment. A controller processes this signal, converting it into a readable pressure value displayed on the interface. The device’s power source energizes both the sensor and controller. Additionally, a cannula, made of rigid material and having a small inner diameter, extends from the coupling unit and inserts into the eye to deliver fluid, forming part of a comprehensive fluid chamber system sensed by the pressure sensor.

[0006] In some embodiments, an intermediate sensing device includes a coupling unit and a sensing unit. The intermediate device connects to both a fluid container and a patient interface (e.g., cannula). The intermediate device can measure one or more physiological parameters, such as pressure. The sensing unit can include a controller that obtains the physiological parameters and transmits physiological readings to a display interface.

[0007] In some embodiments, a medical device comprises a fluid chamber configured to contain fluid. The medical device includes a plunger comprising a stopper and a plunger housing configured to be moveable within the fluid chamber. The medical device includes a pressure sensor disposed at least partially within the plunger such that the pressure sensor is configured to be in fluid communication with the fluid chamber. The medical device includes a calibration sensor configured to generate calibration data. The medical device includes a controller in electrical communication with the pressure sensor. The controller can receive, from the pressure sensor, pressure data while the fluid chamber is in fluid communication within an interior of a patient. The controller can receive, from the calibration sensor, the calibration data. The controller can generate a pressure reading based on the pressure data and the calibration data, wherein the pressure reading is indicative of a pressure of the interior of the patient. The controller can transmit the pressurereading to a display interface. The controller can cause the display interface to display the pressure based on the pressure reading.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The following drawings and the associated descriptions arc provided to illustrate implementations of the present disclosure and do not limit the scope of the claims. Aspects and many of the attendant advantages of this disclosure will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings:

[0009] FIG. 1A schematically shows an example insertion sensing device having a physiological sensor, according to some implementations.

[0010] FIG. IB schematically shows example insertion sensing device having a physiological sensor, according to some implementations.

[0011] FIG. 1C schematically shows an example insertion sensing device having a physiological sensor at or near a tip of the cannula, according to some implementations.

[0012] FIG. ID schematically shows a detail of an example tip of a cannula with a physiological sensor, according to some implementations.

[0013] FIG. IE schematically shows an example The fluid injection sensing device with a physiological sensor, according to some implementations.

[0014] FIG. IF schematically shows an example intermediate sensing device having a physiological sensor, according to some implementations.

[0015] FIG. 2 schematically shows an example insertion sensing device having a relief valve, according to some implementations.

[0016] FIG. 3A shows a perspective view of the insertion sensing device, according to some implementations.

[0017] FIG. 3B shows a side view of the insertion sensing device of FIG. 3 A.

[0018] FIG. 3C shows a top view of the insertion sensing device of FIG. 3 A.

[0019] FIG. 4A shows an example fluid injection sensing device, according to some implementations .

[0020] FIG. 4B shows a cross-section of a detail view of the fluid injection sensing device.

[0021] FIG. 5 A shows a top view of an example intermediate sensing device, according to some implementations.

[0022] FIG. 5B shows a perspective view of the example intermediate sensing device of FIG. 5A, according to some implementations.

[0023] FIG. 5C shows a cross- section of a side view of the example intermediate sensing device of 5 A, according to some implementations.

[0024] FIG. 6A shows a perspective view of a fluid injection sensing device, according to some implementations.

[0025] FIG. 6B shows the fluid injection sensing device of FIG. 6A without the housings of the sensing unit and the interface control unit, according to some implementations.

[0026] FIG. 6C shows a cross section side view of the fluid injection sensing device of FIG. 6 A, according to some implementations.

[0027] FIG. 7 shows an example method of displaying one or more physiological parameters.

[0028] FIG. 8A shows an exploded view of an example medical device, according to some implementations.

[0029] FIG. 8B shows a perspective view of the medical device (e.g., as seen by a user during operation) of FIG. 8A, according to some implementations

[0030] FIG. 8C shows a cutaway view of the medical device of FIGS. 8A-8B, with a portion of the plunger housing removed, along with the fluid chamber.

[0031] FIG. 8D shows a cross section of a portion of an example medical device, according to some embodiments.

[0032] FIG. 9 shows an example method of generating a physiological reading, according to some implementations.

[0033] FIG. 10 example system components of an example system according to example implementations of the present disclosure.DETAILED DESCRIPTION

[0034] Although certain preferred implementations, embodiments, and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed implementations to other alternative implementations and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of theparticular implementations described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain implementations; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various implementations, certain aspects and advantages of these implementations are described. Not necessarily all such aspects or advantages are achieved by any particular implementation. Thus, for example, various implementations may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0035] The present disclosure relates to advanced medical devices, such as those where sensing an environment within human tissue is helpful or necessary. For example, the embodiments described herein may be used in ophthalmic surgeries such as cataract surgeries, spinal fluid pressure measurements, compartment pressure measurements, venous or other blood pressure systems, gas (e.g., air) pressure within a patient (e.g., nasal pressure, intrapulmonary pressure within the lungs, intraperitoneal pressure (IPP)), and / or nutrient or other analyte measurements in human body fluids and / or tissues (e.g., blood, urine, spinal fluid, saliva, fat tissue, muscle tissue, stomach acid, etc.), such as oxygen concentration or electrolyte concentration. Although generally referencing a human patient, a patient may also include an animal, such as a pet, livestock, and / or other animal (e.g., horse, dog, cow, pig, mouse, monkey, etc.). It can be valuable to have the device be portable, light, fully self-contained, and / or disposable (e.g., one- use), which variously apply to the embodiments described herein. For example, disposable devices can improve assurances that the device is sterilized and safe. Moreover, many devices cannot be reasonably sterilized and thus cannot be used in a sterile field of a surgical operation.

[0036] For example, measuring the pressure in cerebrospinal fluid (CSF) can be helpful for diagnosing and managing various medical conditions that affect the brain and spinal cord. The CSF surrounds and cushions these structures, and its pressure can indicate the presence of issues such as infections, bleeding, or brain tumors.

[0037] Measuring the pressure of the spinal fluid is frequently done by a procedure called a lumbar puncture (e.g., spinal tap). In this procedure, a doctor inserts a cannula into a lower part of the spinal column, where the CSF is located. Once the cannula is in place, the fluid’s pressure can be measured, and a sample of the fluid can be collected for analysis. Embodiments of medical devices (e.g., sensing devices, intermediate devices, implantable devices, and / or insertion devices) described herein can be used to aid a practitioner in, for example, measuring the CSF pressure. Such measurements may be made in real time, with higher accuracy and / or precision, and more conveniently track pressure changes in the CSF.

[0038] As another example, measuring compartment pressure in a patient using a cannula can be used to diagnose and / or treat a condition called compartment syndrome. Compartment syndrome occurs when pressure builds up within the muscles, which can reduce blood flow, preventing nourishment and oxygen from reaching nerve and muscle cells. Failure to detect and diagnose compartment syndrome in a timely manner can lead to muscle and / or nerve damage and may even require amputation if not treated promptly. Embodiments described herein can measure the compartment pressure in real time and determine the severity of the condition. For example, a cannula of or associated with a medical device (e.g., sensing devices, intermediate devices, implantable devices, and / or insertion devices) can be inserted into the affected muscle compartment. The device or system can measure the pressure and allow a doctor or assistant to assess the severity of any compartment syndrome.

[0039] In further examples of pressure sensing, embodiments described herein can be used in the context of nasal and / or intrapulmonary pressure sensing. For example, when delivering gas to a patient (e.g., via a nasal cavity or channel), if delivered gas continues to flow into a blocked, collapsed, or otherwise impeded conduit leading into a nasal cannula, a dangerous situation may arise. The pressure may build up in the conduit and cause the conduit to burst. Additionally or alternatively, the gas could force its way through the impeded portion of the conduit and into the nasal cannula, driving unwanted pressure in the patient's lungs or airway. Embodiments described herein could reduce or prevent such risks and thus damage to a patient.

[0040] In some examples, drug or other analyte delivery may be needed for a patient. The delivery of the drug may be sensitive to a pressure at the site of delivery (e.g., within an eye, lung, ear, or brain of a patient). Additionally or alternatively, the amount of drug or analyte to be delivered may need to be precisely measured to avoid over- or under-delivery of the dose.Accordingly, embodiments described herein can prevent an over- or under-pressurization of an interior of a patient tissue and / or an over- or under-dosing of an analyte (c.g., drug, nutrient, etc.).

[0041] As a further example, embodiments described herein may include a temperature sensor that can detect elevated or depressed temperatures within a tissue of a patient. This may be done by measuring the temperature of fluid in communication with and / or extracted from a tissue of a patient. For example, an insertion sensing device may include a physiological sensor at or near a tip of a cannula (and / or elsewhere in the medical device or system) to quickly and accurately measure a temperature of the patient’s tissue or body fluid therein. In this way, abrupt changes in a patient’s temperature can be readily sensed and presented (e.g., displayed) to a practitioner.

[0042] Yet another example includes analyte sensing. Embodiments described herein may include one or more glucose sensors, oxygen sensors (e.g., blood oxygen sensors), electrolyte sensors, pH sensors, and / or other analyte sensors to give a medical practitioner a measurement of a patient’s target analyte levels. These analytes may be accessible via a cannula tip and thus quickly, accurately, and / or conveniently measured. For example, it may be useful to identify certain proteins that may serve as biomarkers for one or more diseases or other medical conditions. As another example, a blood oxygen concentration may be measured via a cannula tip, as described herein. In some embodiments, the medical device may include a blood glucose sensor that can be attached to (e.g., implanted on or in) a patient. The medical device may measure a continual blood glucose level based on an analyte reading and / or on a calibration reading (e.g., another analyte reading, temperature reading, pressure reading, etc.).

[0043] Other examples include in ophthalmology, such as cataract and retinal surgeries. It can be necessary to re-pressurize a patient’s eye at or near a conclusion of a cataract or other surgery. Knowing the pressure of the patient’s intraocular pressure (IOP) can be beneficial to avoid complications and / or promote healthful patient outcomes. Traditional methods rely on subjective assessment (e.g., manually pressing on a surface of the eye), which can lead to variability in measurements and thus potential health risks. Embodiments described herein can integrate a pressure sensor within a surgical instrument to provide real-time, accurate measurements of IOP, enhancing surgical precision and patient safety.

[0044] Current cataract surgery techniques lack real-time IOP monitoring, relying instead on the surgeon’s experience and tactile feedback (“palpation”). Reliance on palpation can lead to inaccuracies in pressure estimation, risking postoperative complications such asastigmatism or elevated TOP. Embodiments described herein can address this gap by offering an objective and precise method to monitor TOP continuously during surgery.

[0045] Various embodiments integrate the flow of the fluid during the injection process with the TOP measurement. This integration can allow for seamless operation during surgery, improving the standard surgical workflow while providing critical TOP data without additional steps or equipment. A sensing unit can include a pressure sensor positioned to measure the fluid pressure within a fluid channel. The fluid within the patient’s eye, the cannula, and a syringe can form a composite fluid chamber. When the composite fluid chamber reaches pressure equilibrium, the device may be able to measure the IOP of the patient’s eye while the cannula is inserted into the patient’s eye. Additionally or alternatively, the pressure sensor may be disposed at or near a tip of the cannula such that the pressure sensor is inserted into the eye of the patient, thus providing a direct measurement of the IOP of the patient’s eye.

[0046] Further in the ophthalmic context, embodiments described herein may allow theIOP to be measured during partial thickness cornea transplant surgery (e.g., lamellar keratoplasty). During the procedure, gas (e.g., air, sulfur hexafluoride (SFe) may be injected into the eye to pressurize the eye to help the partial thickness tissue adhere. Tracking this pressure using embodiments herein can help avoid post-operative complications by better managing the pressure in real-time.

[0047] In some embodiments (e.g., within an ophthalmic context), the medical device may include a fluorescence sensor (e.g., additionally or alternatively to a pressure sensor) to detect and / or quantify retained viscoelastic material following ocular procedures such as cataract surgery. The fluorescence sensor may be integrated into the assembly of the medical device (e.g., cannula, syringe, intermediate device, implantable device, etc.). One or more optical components may be positioned within the medical device to analyze fluid samples drawn through the device (e.g., into a fluid chamber of a syringe and / or of an intermediate device). For example, the fluorescence sensor can be embedded within a plunger housing, near the fluid chamber, and / or within a stopper. An optical pathway for the sensor may be aligned to detect fluorescence emissions from within a tissue of a patient (e.g., within an eye of the patient). The device can include an excitation light source (e.g., an LED, laser diode) configured to emit a target wavelength of light for exciting fluorescent dye within the viscoelastic material. Upon excitation, the viscoelastic can emit light at a longer wavelength, which may be detected by a photodetector of the medical device (e.g., aspectrometer within the medical device) and / or a device remote from the medical device. The detected fluorescence intensity can correlate with a concentration of viscoelastic material in the sampled fluid. If viscoelastic material is retained, the practitioner may seek to continue to remove additional viscoelastic material. The sensor can be calibrated against known and / or expected viscoelastic concentrations so that the system can provide a quantitative assessment of retained viscoelastic. Additionally or alternatively the medical device may alert the practitioner if material above a threshold amount remains in the tissue (e.g., anterior chamber of the eye).

[0048] It may be valuable to identify a fluid-filled tissue space within the body. This may be done by stopping fluid flow at a particular time (e.g., based on a predetermined pressure measurement) and then resuming fluid flow once a threshold condition is met (e.g., when the measured pressure drops below a predetermined pressure threshold). For example, an epidural tissue-space may be a target location for delivering anesthesia to lower extremities of a patient’s body, such as during labor and delivery. The epidural tissue-space is a fluid filled space that is very narrow and traditionally identified via a “loss-of-resistance” technique, relying on a change of friction to signal when the space has been reached. The needle is further advanced until the subjective “feel” of resistance by the clinician results in a distinct “back-pressure” on the plunger. One problem with this technique is loss of fluid into the tissues when the tip of the needle is in ligament tissue. Identification of narrow or small target tissue sites, like the epidural tissue-space can be quickly and accurately identified using embodiments described herein.

[0049] Embodiments described herein can also measure a blood pressure (e.g., venous blood pressure, arterial blood pressure). For example, the device may couple (e.g., as a syringe embodiment, intermediate device embodiment) to a catheter that is in fluid communication with a blood vessel of a patient.

[0050] Various embodiments can include a controller connected to or otherwise coupled with the sensing unit. This controller can process signals (e.g., pressure signals, analyte signals, temperature signals, etc.) from the physiological sensor and convert the signals into a readable value displayed on a user interface. The user interface may be integrated into the medical device and / or may be remote from the medical device. In some embodiments, the device can include an onboard power supply. This can allow for mobility during the surgery or other investigation done by the practitioner. Some embodiments may be constructed so that the deviceis disposable in part or in whole. Some of the device or system components may be reusable while others may be disposable.

[0051] Reference will now be made to the figures. The embodiments shown in the figures are nonlimiting and serve to provide examples of embodiments described herein. FIG. 1 A schematically shows an example insertion sensing device 104 having a physiological sensor 120, according to some implementations. Although particular detail has been provided to the example of the medical device 300 below, any one or combination of features and / or details described with regal’d to the medical device 300 can apply to any insertion device embodiment (e.g., the insertion sensing device 104). As shown in FIG. 1A, the sensing system 100 includes an insertion sensing device 104 and a fluid injection device 112. The insertion sensing device 104 may be operatively coupled with the fluid injection device 112 to provide some or all of the functionality described herein related to the insertion sensing device 104. The insertion sensing device 104 may be coupled (e.g., releasably couplable) to the fluid injection device 112 by coupling an insertion device coupling unit 108 to the fluid container coupling unit 126. The fluid injection device 112 can include a syringe. In some embodiments, the fluid injection device 112 can include a fluid pump or other actuator coupled to a fluid container (e.g., IV bag). In still further embodiments, the fluid injection device 112 can include a passive fluid delivery system (e.g., an IV bag delivery system relying on gravity pressure) without a fluid pump or other fluid actuator.

[0052] When the insertion sensing device 104 and the fluid injection device 112 are coupled together, the fluid inlet 106 of the insertion sensing device 104 and the fluid outlet 114 of the fluid injection device 112 may be in fluid communication. This may allow the fluid in the fluid chamber 118 to be ejected or expelled by the fluid actuator 122 or a fluid driver out of the fluid outlet 114 and into the fluid inlet 106. Fluid may then pass through the fluid channel 110 and through an interior of the cannula 128 and into an interior of the patient tissue (e.g., inside an eye, inside muscle tissue, inside a spinal column, inside a blood vessel, etc.).

[0053] The insertion device coupling unit 108 can be connected to or otherwise coupled to a sensing unit 116. The insertion device coupling unit 108 may be referred to as a cannula “hub” in some contexts. The sensing unit 116 can have a housing that includes a physiological sensor 120 and a controller 124 therein for communicating with the physiological sensor 120. The controller 124 can include a memory and one or more processors, such as hardware and / or electrical processors. The memory can store instructions thereon readable by the one ormore processors to perform one or more methods described herein. In some embodiments the controller 124 includes one or more microcontrollers.

[0054] The cannula 128 can include an elongate, generally hollow tube. The cannula 128 may be formed from a rigid material. For example, aluminum or other metals are commonly used in the ophthalmic and surgical contexts. However, in some embodiments the cannula 128 may be formed of rigid polymer, such as polyethylene, polypropylene, polystyrene, polyvinyl chloride (PVC), polycarbonate, and / or other sufficiently rigid material(s). In certain embodiments, particularly where structure integrity of the cannula is important, such as whenever the cannula is to be inserted through a patient’s tissue (e.g., skin, cornea, muscle, vascular tissue, stomach lining, etc.), a metal or hard polymer may be used. The material of the cannula 128 may be selected for biocompatibility of the target tissue in which the cannula 128 may be injected or inserted. The cannula 128 can have an inner diameter (ID) and outer diameter (OD) sufficient to eject fluid at reasonable fluid flux.

[0055] This may depend on the medical context. For example, in the context of ophthalmic procedures, a higher gauge (e.g., smaller ID and OD) cannula 128 may be preferred to reduce the size of required incisions in the cornea or other parts of the eye. Additionally, a high fluid flux may not be required due to the relatively small volume of the eye. By contrast, a moderate gauge size may be used in a compartment pressure and / or spinal / epidural context. For environments involving flowing blood (e.g., vascular tissue), a much lower gauge size (e.g., larger ID and OD) may be preferred. Accordingly, an ID of the cannula 128 may be about 0.05 mm, about 0.1 mm, about 0.13 mm, about 0.16 mm, about 0.19 mm, about 0.21 mm, about 0.26 mm, about 0.35 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 1 mm, about 1.3 mm, about 1.6 mm, about 1.8 mm, about 2.2 mm, about 2.4 mm, about 2.7 mm, have any value therein, or fall within a range having endpoints therein. In some embodiments, the cannula 128 has an ID less than about 0.3 mm. An OD of the cannula 128 may be about 0.15 mm, about 0.2 mm, about 0.23 mm, about 0.26 mm, about 0.29 mm, about 0.31 mm, about 0.36 mm, about 0.45 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.3 mm, about 1.6 mm, about 1.8 mm, about 2.1 mm, about 2.5 mm, about 2.7 mm, about 3 mm, about 3.4 mm, have any value therein, or fall within a range having endpoints therein. In some embodiments, the cannula 128 has an OD less than about 0.5 mm.

[0056] In some contexts, and thus in some embodiments, a more resilient and / or flexible material may be used. For example, in contexts where the cannula 128 may be inserted into a nasal passage of the patient or where the cannula is otherwise not inserted into a patient’s tissue (e.g., certain portions of a cannula that may be part of a catheter), a preference for less rigid materials may be selected. Such a material may allow for more “play” in the cannula 128, perhaps allowing for movement of the cannula 128 and / or of other elements interfacing with the cannula 128. In such contexts, embodiments may include a cannula 128 with more flexible polymers (e.g., polyurethane, polyethylene), silicone, rubber, and / or thermoplastic elastomers.

[0057] The cannula 128 may include two or more elongate tubes, lumens, or cannulas. In some embodiments, a first cannula is configured to expel fluid into and / or intake fluid from an interior of a patient tissue. A second cannula can be in fluid communication with the physiological sensor 120. For example, in such contexts the physiological sensor 120 may include a resilient membrane or diaphragm configured to be responsive to pressure (e.g., fluid pressure) incident thereon. In some embodiments, the first and second cannulas of the cannula 128 are parallel to one another. In some embodiments the first and second cannulas are both configured to terminate within the interior of the patient tissue. In other embodiments, at least one of the cannulas (e.g., the second cannula) is configured to have a terminus before a terminus of the other cannula.

[0058] FIG. IB shows another example of an insertion sensing device 104 of a sensing system 100, according to certain implementations. As shown, the insertion sensing device 104 can include a sensing unit 116 having a physiological sensor 120, a controller 124, apower source 140, a pull-tab 144, and / or a user interface 136.

[0059] The insertion sensing device 104 and the fluid injection device 112 can be coupled along a fluid axis 148. The cannula 128 may be disposed completely or partially along the fluid axis 148. The cannula 128 may include one or more bends. For example, in some embodiments (e.g., in embodiments with a more rigid cannula 128), the cannula 128 can include an axial portion and an inclined portion (not shown in FIG. IB; see, e.g., FIG. 3C). The axial portion of the cannula 128 may extend from the insertion device coupling unit 108 along the fluid axis 148. The inclined portion can form an angle (e.g., obtuse angle) subtending the axial portion and the inclined portion. In some embodiments, the angle is between about 110° and about 170°. In some embodiments, the angle is about 135°. Such angles can allow a practitioner to more precisely target regions of the patient’s body. The angle selected may be based on the applicationneeded. For example, for getting around hard tissue, a bend with a sharper (e.g., less obtuse) angle may be selected. Additionally or alternatively, a bend may be preferred by practitioners in ophthalmological settings since manipulating the device inside the eye may include angular restrictions due to the physiology of the eye. By contrast, a very obtuse angle, or possible a straight angle, may be selected if direct access to a tissue is preferred (e.g., in compartment pressure measurements, in some cataract surgery settings, etc.).

[0060] The sensing unit 116 can be attached or otherwise coupled to the insertion device coupling unit 108. The sensing unit 116 can include any one or combination of features described with regard to the flexible PCB 394 and / or the rigid PCB 395, and / or any electronic components coupled thereto. One or more physiological sensors of the physiological sensor 120, the controller 124, the pull-tab 144, the power source 140, and / or the user interface 136 may be disposed at a radially different distance from the fluid axis 148. For example, one or more of these elements may be stacked on one another in a radial direction. Such a compact arrangement can allow for easier manufacture of the sensing unit 116. Additionally or alternatively a radially compact arrangement can allow for one or more elements to be combined into a separate module that may be removable from the rest of the sensing unit 116. In some embodiments, the sensing unit 116 is configured to be removably attached to the insertion device coupling unit 108. This may be valuable, for example, if the sensing unit 116 is to be reused from procedure to procedure where one or more other elements of the insertion sensing device 104 (e.g., the rest of the insertion sensing device 104 aside from the sensing unit 116) can be disposable.

[0061] In some embodiments, the whole insertion sensing device 104 (e.g., including the sensing unit 116) is configured to be disposable. The sensing unit 116 may have a relatively small form factor. For example, in some embodiments, the sensing unit 116 has a length or circumference of less than about 20 mm. Additionally or alternatively, the sensing unit 116 can have a width of less than about 20 mm and / or a depth of less than about 10 mm, or even less than 8 mm in some embodiments. Such a small form factor can allow the device to couple the fluid injection device 112 without impeding its functionality. Additionally, a small form factor allows the device to be used properly by a practitioner without creating such a heavy off-axis force that may disturb practitioners during its use. A smaller form factor than this raises serious engineering constraints related to, for example, power budget of the power source 140, functionality of the user interface 136, and accuracy of the physiological sensor 120. While taken individually, “better”versions of one or more of these elements may already exist, working in concert this form factor achieves functionality that has not been achieved previously for the contexts provided herein.

[0062] The sensing unit 116 may be approximately form a rectangular prism or a cylinder. The sensing unit 116 and the insertion device coupling unit 108 may be welded, adhered, molded (e.g., injection molded), or otherwise merged together to form a unitary structure such that the sensing unit 116 and the insertion device coupling unit 108 cannot be separated without substantially damaging one or both of the units. The unitary structure may include one or more of glass, polycarbonate, and / or polypropylene. In other embodiments, however, the sensing unit 116 may be releasably coupled to the insertion device coupling unit 108, such as in FIGS. 6A-6C.

[0063] In some embodiments, one or more of these elements may be disposed circumferentially about the fluid axis 148. For example, the physiological sensor 120 and the controller 124 may be disposed at nearly the same radial distance from the fluid axis 148. Circumferential disposition of elements about the fluid axis 148 can improve ergonomics of the insertion sensing device 104 for a practitioner (e.g., clinician, doctor, assistant, nurse, surgeon, technician, etc.). Additionally or alternatively, it may reduce effective outer diameter of the insertion sensing device 104.

[0064] The physiological sensor 120 can include one or more sensors. The physiological sensor 120 can be configured to be in fluid communication with the fluid channel 110 of the insertion sensing device 104. This may allow the physiological sensor 120 to directly sense one or more physiological parameters of the fluid therein. The physiological sensor 120 may include a sensing surface having a face. A normal of the face may be transverse (e.g., substantially orthogonal) to the fluid axis 148. The physiological sensor 120 can include one or more types of sensors. Types of physiological sensors include pressure sensors, optical sensors, chemical sensors, temperature sensors, electrical sensors, and / or analyte sensors. For example, pressure sensors may include membrane- or diaphragm-based sensors, resistive sensors, capacitive sensors, fiber optic sensors, piezoelectric sensors, optical sensors, strain gauge sensors, silicon-on-insulator (SOI) sensors, microelectromechanical systems (MEMS) sensors, ceramic pressure sensors, ionization gauges, ultrasound transducers, and / or Hall effect sensors.

[0065] The physiological sensor 120 can include, for example, a MEMS sensor that integrates mechanical and electrical components to obtain an electrical signal that can then be converted to a pressure reading. In some embodiments, the physiological sensor 120 includes aMEMS pressure sensor that has a sensing surface of less than about 200 microns and an outer diameter of about 330 microns (about 1 Fr). In some embodiments, such a physiological sensor 120 is located at or near’ the tip of the cannula 128 (see, e.g., FIG. 1C below). Due to the size, functionality, and cost, the MEMS sensors may allow for disposable (e.g., single-procedure use) pressure sensing capabilities. This can improve design by making the elements smaller as they may not need to be subject to sanitization between procedures. Additionally or alternatively, the physiological sensor 120 can include a piezoelectric sensor that relies on subtle changes in movement to generate an electrical signal. For example, certain embodiments include MEMS sensors having one or more piezoelectric sensor elements therein.

[0066] In some embodiments, the insertion sensing device 104 includes a fiber optic sensor that includes a resilient and / or deformable surface (e.g., membrane, diaphragm). The surface may be in fluid communication with a target site within an interior of the patient’s tissue (e.g., eye, muscle tissue, blood vessel, epidural tissue-space, interspinous tissue, interior of ear, etc.). Additionally or alternatively, the surface may be in fluid communication with a fluid that is itself in fluid communication with a surface of the patient tissue, a pressure within which may be a target for pressure sensing. The insertion sensing device 104 can emit coherent light onto the deformable surface and determine a change in pressure based on interference patterns in the light. Additionally or alternatively, the physiological sensor 120 can include different kinds of optical sensors that use the coherent light to detect changes in interference patterns in the light.

[0067] In some embodiments, the physiological sensor 120 may include a strain gauge that includes resistive and / or capacitive sensors that measure the deformation of the strain gauge in response to a change in a pressure. Various sensing technologies described herein (e.g., MEMS) may include strain gauges. In some embodiments, the physiological sensor 120 can include a SOI sensor. The SOI sensor may include a silicon layer that is less than about 5 microns, and in some embodiments less than about 1 micron, thick. Pressure applied to the SOI sensor results in mechanical stress in the silicon layer. This stress changes the electrical resistance of the piezoresistive materials in the device layer of the SOI pressure sensor. Embodiments with SOI sensors enjoy the benefits of reduced parasitic capacitance due to the insulating layer, which improves the performance of the physiological sensor 120. Such embodiments also offer better isolation of the physiological sensor 120 from the substrate, thus improving sensitivity and stability and reduced temperature sensitivity.

[0068] The physiological sensor 120 can additionally or alternatively include a glucose or other electrochemical sensor. For example, the physiological sensor 120 can include a chemical catalyst, such as a biochemical catalyst (e.g., enzyme). Some embodiments include a glucose sensor having an enzyme, such as glucose oxidase (GOx) or glucose dehydrogenase (GDH), that is configured to catalyze oxidation of the glucose. The physiological sensor 120 can be configured to track an amount of gluconic acid and / or hydrogen peroxide is catalyzed in a bodily fluid (e.g., blood, interstitial fluid, saliva, etc.). The physiological sensor 120 may receive an electrical signal based on (e.g., directly proportional to) the amount of glucose that has been oxidized. The physiological sensor 120 may be configured to measure a relative glucose concentration and / or an absolute glucose level.

[0069] In some embodiments, the physiological sensor 120 includes a blood oxygen sensor. The blood oxygen sensor can include a first light source (e.g., LED) configured to emit light the red spectrum (e.g., between about 620 nm and 750 nm, and in some embodiments about 660 nm) and a second light source configured to emit light in the infrared spectrum (e.g., between about 750 nm and 1200 nm, and in some embodiments around 940 nm). The oxygenated hemoglobin (e.g., oxyhemoglobin) and deoxygenated hemoglobin (e.g., deoxyhemoglobin) will absorb light differently at these wavelengths. The physiological sensor 120 can include a detector such that a blood sample sits or flows between the detector and the physiological sensor 120. As the physiological sensor 120 emits light from the first and second light sources, the detector can capture light that has passed through the blood sample between the detector and the physiological sensor 120. Based on the different absorbance at each wavelength, the controller 124 can calculate a ratio of the red light to the infrared light and convert this ratio into a blood oxygen reading. The blood oxygen reading may correspond to an oxygen saturation percentage and / or absolute value of blood oxygen in the blood sample.

[0070] The physiological sensor 120 can be configured to measure a pressure within a tissue of the patient. The pressure may correspond to a fluid pressure, such as a liquid pressure or gas pressure. For example, the physiological sensor 120 can be configured to determine an intraocular pressure (IOP) of a patient, a compartment pressure of a patient’s body part (e.g., leg, arm), a blood pressure within the patient’s vascular system, an air pressure within the patient’s respiratory system, a sinus pressure, a middle ear pressure, and / or other fluid pressure of the patient. The pressure measured may be an absolute pressure or a relative pressure to an atmosphereexterior to the patient’s tissue. For example, measurement of TOP may be a relative pressure measurement relative to atmosphere exterior to the patient’ s eye.

[0071] The physiological sensor 120 can include a pressure sensor configured to measure pressure within the interior of the patient’s tissue. The pressure sensor can be configured to measure about 1 mmHg, about 2 mmHg, about 3 mmHg, about 5 mmHg, about 8 mmHg, about 10 mmHg, about 12 mmHg, about 15 mmHg, about 17 mmHg, about 20 mmHg, about 22 mmHg, about 25 mmHg, about 30 mmHg, about 35 mmHg, about 40 mmHg, about 45 mmHg, about 50 mmHg, about 60 mmHg, about 100 mmHg, about 150 mmHg, about 180 mmHg, about 200 mmHg, about 250 mmHg about 300 mmHg, any value therein, or fall within a range having endpoints therein. In some embodiments, for example, the pressure sensor can measure a relative and / or absolute pressure of between about 0 mmHg and about 40 mmHg. In the context of IOP, compartment pressure, a relative pressure greater than about 30 mmHg may be considered abnormal and may require correction or even medical attention. Accordingly, the pressure sensor may be able to measure what is considered a normal range and at least some range outside the normal range, in order to confirm that a pressure is in fact abnormal. The accuracy of the pressure sensor may be between about 2% and about 10% of some “correct” value, depending on the pressure range, with higher pressure ranges tending to be more accurate.

[0072] The physiological sensor 120 can be in fluid communication with the fluid channel 110 of the insertion sensing device 104. Fluid can be injected into and / or removed from the interior of the patient tissue using the fluid actuator 122. The fluid actuator 122 can drive fluid out of the fluid chamber 118 via the fluid outlet 114 of the fluid injection device 112. The fluid chamber 118 may be configured to contain less than about 5 mL of fluid at once. The fluid may pass into the fluid inlet 106 and through the fluid channel 110 of the insertion sensing device 104. The fluid can pass through an interior of the cannula 128 and into the interior of the patient tissue. The physiological sensor 120 can be configured to measure the pressure applied by the fluid actuator 122 during delivery of fluid into and / or during removal of fluid from the interior of the patient tissue. The fluid actuator 122 can include a plunger flange, a plunger, and / or a piston (or seal). The seal can include a rubber or other resilient material. The fluid channel 110 may have a substantially larger inner diameter (ID) than an ID of the cannula 128. The ID of the fluid channel 110 may be less than about 4 mm and / or greater than about 1 mm.

[0073] In some embodiments, the physiological sensor 120 can be configured to measure a fluid pressure within the interior of the patient tissue once the fluid has reached pressure equilibrium (e.g., “equalized”). This may be possible when the interior of the target site to be measured forms a closed substantially closed fluid chamber with the interior of the cannula 128, the fluid channel 110, and the fluid chamber 118. This is possible in compartment pressure measurements since the muscle tissue of the patient’s body part is effectively a closed fluid system. Measurements of IOP using this method are also usually possible since the interior of the eye is generally effectively a closed fluid system. This is because at the conclusion of an eye procedure, the surgeon or nurse will typically repressurize the eye with some solution (e.g., saline solution), which helps to keep the incisions made into the eye closed. Moreover, during the cataract surgery, another fluid (e.g., viscoelastic) is often injected into the eye to keep the IOP at a proper physiological level. When the eye has a sufficient IOP (e.g., greater than about 5 mmHg), the insertion sensing device 104 can generally rely on a closed pressure system to allow the physiological sensor 120 to measure the pressure inside the eye or other tissue even though the physiological sensor 120 may be disposed some distance from the target site. If the system creates a closed fluid pressure system, this may be referred to as a composite fluid chamber where the fluid pressure is measurable (e.g., substantially uniform) throughout the composite fluid chamber.

[0074] The controller 124 can be operatively coupled to the physiological sensor 120 such that the controller 124 and the physiological sensor 120 can communicate power and / or information with each other. The controller 124 can include one or more controllers. One or more of the controllers may be coupled (e.g., connected) to the insertion sensing device 104 and / or remote from the insertion sensing device 104. In some embodiments, one or more controllers of the controller 124 may be remote from and / or communicate with the physiological sensor 120 via a wireless data interface. The controller 124 can include instructions thereon that, when executed by the one or more processors, can perform various tasks. For example, the controller 124 can cause the physiological sensor 120 to obtain various physiological readings of and / or physiological signals from an interior of the patient tissue. The controller 124 can receive one or more physiological signals and convert the one or more physiological signals into one or more physiological readings that can be read by another electrical device, such as the user interface 136. The physiological signals may be in a first information form, and the physiological readings may be in a second information form. Example information forms include a voltage value, a resistancevalue, a current value, a displacement, a frequency, an amplitude, and the like. For example, the physiological signals may correspond to an analog voltage signal, and / or the physiological readings may correspond to a digital frequency signal. Signals and readings may be of a different type (e.g., analog, digital, electromagnetic, etc.) or of a common type. The controller 124 may be configured to convert the first information form into the second information form. In some embodiments, the first and second information forms are the same and / or are of the same type.

[0075] The controller 124 may transmit the one or more physiological readings to the user interface 136 and / or cause the user interface 136 to display one or more indications of the physiological signal(s) received, based on the one or more physiological readings.

[0076] The power source 140 can be a mobile power source (e.g., a battery) and / or a wired power source. The power source 140 can be configured to generate a current output of at least about 1 mAh, at least about 1.5 mAh, at least about 2 mAh, at least about 2.5 mAh, at least about 3 mAh, at least about 4 mAh, at least about 5 mAh, at least about 10 mAh, at least about 50 mAh, any value therein, or fall within a range having any values therein as end points. Although greater current output may be generally desired, physical constraints (e.g., of a housing of the sensing unit 116, space constraints of the insertion sensing device 104) and electrical constraints (e.g., type of controller, sensitivity of electrical components, space for electrical resistive elements, etc.) may influence a choice of the current output. Other constraints, such as medical, regulatory, and / or other constraints may influence the choice for the selected current output of the power source 140. For example, in some embodiments, the power source 140 can generate a current output of at least 1.0 mAh.

[0077] A maximum current output of the power source 140 may determine how long the power source 140 can power one or more of the components of the sensing unit 116 and / or other components of the insertion sensing device 104. The power source 140 can have a maximum current of at least about 0.25 mA, at least about 0.5 mA, at least about 0.75 mA, at least about 1 mA, at least about 2 mA, at least about 3 mA, at least about 5 mA, at least about 7 mA, at least about 10 mA, at least about 12 mA, at least about 15 mA, at least about 20 mA, at least about 25 mA, at least about 50 mA, any value therein, or fall within a range having any values therein as end points. As with current output described above, greater maximum current output can provide additional benefits, but physical, electrical, medical, regulatory, and / or other constraints mayinfluence the choice for the selected maximum current output of the power source 140. In some embodiments, the maximum current output of the power source 140 is at least about 2 mA.

[0078] Measures of voltage output may be more helpful in certain contexts. The power source 140 may be able generate a voltage of at least about 0.5 V, at least about 0.75 V, at least about 1 V, at least about 1.25 V, at least about 1.5 V, at least about 2 V, at least about 2.5 V, at least about 3 V, at least about 3.5 V, at least about 5 V, at least about 7 V, at least about 10 V, any value therein, or fall within a range having any values therein as end points. The relationship between voltage and current output of the power source 140 may be related according to Ohm’s law. Accordingly, the measured current output may be based on a total resistance of the controller and / or other electrical components described herein of the insertion sensing device 104. In some embodiments, the voltage output is at least 1.0 V.

[0079] The power source 140 may be generally cylindrical in some embodiments. For example, the power source 140 may include a button battery. The power source 140 may include an A 10 battery in some embodiments. In some embodiments, the power source 140 may be rechargeable (see, e.g., the charging interface 206 of FIG. 6C).

[0080] The pull-tab 144 may be configured to electrically insulate the power source 140 from one or more elements of the insertion sensing device 104. For example, the power source 140 may insulate the power source 140 from one or more elements of the user interface 136, such as the controller 124, the physiological sensor 120, and / or the user interface 136. The pull-tab 144 may be configured to allow user manipulation to remove the pull-tab 144. Removal of the pull-tab 144 can initiate electronic functionality of the insulated elements. The pull-tab 144 can thus reduce leakage of electrical power from the power source 140 when the insertion sensing device 104 or any part thereof (e.g., the sensing unit 116) is not in use and / or not yet ready to be used. The pulltab 144 can be particularly beneficial in embodiments where the power source 140 includes a disposable battery and / or where the sensing unit 116 is configured to be disposable. In some embodiments, the insertion sensing device 104 is configured to be disposable in its entirety. However, in some embodiments the sensing unit 116 and / or elements thereof may be configured to be reusable (e.g., the interface control unit 226 of FIGS. 6A-6C).

[0081] The user interface 136 may include a display interface that can show graphical images and / or text using one or more display technologies including, but not limited to LED, OLED, LCD, or e-ink. The user interface 136 can receive the physiological (e.g., pressure, analyte,temperature, etc.) reading from the controller 124 and display a corresponding physiological parameter based on the physiological reading. The physiological parameter may include an intraocular pressure (IOP) or other fluid pressure (e.g., a compartment pressure, air pressure), a blood oxygen concentration or level, a glucose concentration or level, a temperature, an electrolyte concentration or level, a pH level, and / or some other measurable physiological parameter.

[0082] In some embodiments, the user interface 136 can be configured to receive user input, such as via one or more interface control elements (e.g., an alphanumeric pad). The user interface control elements can allow a user to provide information or interact with the insertion sensing device 104, to modify the settings of the insertion sensing device 104, respond to request for certain actions (e.g., installing a software) and the like. The interface control elements can include an alphanumeric pad having a plurality of keys with numerical, alphabetical, and symbol characters. In different embodiments, the keys of the alphanumeric pad may be capacitive or mechanical. The user may be a practitioner (e.g., a surgeon, doctor, nurse, technician, etc.) or a patient receiving the insertion by the sensing system 100. Additionally or alternatively, the user may be an authorized user, such as a different clinician or healthcare provider, or a parent or guardian of the patient.

[0083] In some other embodiments, the user interface 136 may include a touchscreen display that produces output and accepts input enabling a two-way interaction between the user and the sensing system 100. The touchscreen display may be any input surface that shows graphical images, text, and / or other communicative data. The touchscreen may be configured to register a position of touches on the user interface 136. The touchscreen display may accept input via capacitive touch, resistive touch, or other touch technology. The input surface of the touchscreen display can register the position of touches on the surface. In some examples, the touchscreen display can register multiple touches at once. In some embodiments, the keypad may be a display of a keypad. For example, an alphanumeric pad can include user- selectable letters, numbers, and / or symbols that may be displayed on the touchscreen display. In some examples, the touchscreen may present one or more user-interface screens to a user enabling the user to modify one or more therapy settings of the ambulatory medicament device.

[0084] In some examples, the user interface 136 may comprise one or more interface control elements (e.g., displayed on the touchscreen display, tactile elements located near the display interface) enabling a user to access physiological parameters, modify parameter settings,and / or otherwise modify outputs from the user interface 136 by interacting with these control elements. For example, the user may modify the physiological parameter settings by changing one or more control parameters using a corresponding interface control element.

[0085] In some embodiments, the sensing system 100 and / or portions thereof (e.g., the insertion sensing device 104) can include a communication system having one or more digital data interfaces configured to send and / or receive digital data via a wired or a wireless data link. For example, the communication system may include one or more wireless transceivers, one or more antennas, and / or one or more electronic systems (e.g., front end modules, antenna switch modules, digital signal processors, power amplifier modules, etc.) that support communication over one or more communication links and / or networks. In some examples, each transceiver may be configured to receive or transmit different types of signals based on different wireless standards via the one or more antennas (e.g., an antenna chip). Some transceivers may support communication using a low power wide area network (LPWAN) communication standard. In some examples, one or more transceivers may support communication with wide area networks (WANs) such as a cellular network transceiver that enables 3G, 4G, 4G-LTE, or 5G. Further, one or more transceivers may support communication via a Narrowband Long-Term Evolution (NB-LTE), a Narrowband Intemet-of-Things (NB-IoT), or a Long-Term Evolution Machine Type Communication (LTE-MTC) communication connection with the wireless wide area network. In some cases, one or more transceivers may support Wi-Fi® communication. In some cases, one or more transceivers may support data communication via a Bluetooth or Bluetooth Low Energy (BLE) standard. In some examples, one or more transceivers may be capable of down-converting and / or up-converting a baseband or data signal from and / or to a wireless carrier signal. In some examples, the communication system may wirelessly exchange data between other components of the sensing system 100 (e.g., the user interface 136), a mobile device (e.g., smart phone, a laptop, a wearable device, etc.), a Wi-Fi network, WLAN, a wireless router, a cellular tower, a Bluetooth device, etc. The antenna may be capable of sending and receiving various types of wireless signals including, but not limited to, Bluetooth, LTE, or 3G. For example, in some embodiments the sensing unit 116 includes a wireless transceiver configured to wirelessly transmit and / or receive physiological data (e.g., physiological readings) to and / or from the user interface 136 and / or a separate display interface.

[0086] The communication system may be housed within the sensing unit 116 or within a separate unit (c.g., an interface management unit, such as the interface control unit 226 of FIG. 6A). The communication system may receive data (e.g., physiological data, signals, and / or readings; calibration data; proximity data; orientation data, etc.) from the controller 124 and / or from the physiological sensor 120. Additionally or alternatively, the communication system may transmit the received data to a remote system (e.g., the user interface 136, a smart phone, a wearable device, etc.) for display and / or for further analysis.

[0087] In some examples, the communication system may support direct end-to-end communication between the sensing system 100 and a server or a cloud network. In some examples the sensing system 100 may communicate with an intermediary device (e.g., a smart phone or other mobile devices, a personal computer, a notebook, an iPad, etc.). In some embodiments, the sensing system 100 may include an eSIM card that stores information that may be used to identify and authenticate a mobile subscriber. The eSIM card may enable the sensing system 100 to function as an Internet of Things (loT) device that can communicate over a network that supports communication with loT devices. In other embodiments, the sensing system 100 may be configured to transmit data using a narrowband communication protocol such as 2G or EDGE. Using a cellular connection, the sensing system 100 may be paired with a mobile device at inception and permit real-time data access to the sensing system 100 by a healthcare provider. In certain implementations, the sensing system 100 may include a geolocation receiver or transceiver, such as a global positioning system (GPS) receiver. In some embodiments the communication system may include a Near Field Communication (NFC) sub-system that enables contactless data exchange among one or more elements of the sensing system 100 and other elements of the sensing system 100 and / or an electronic device located in the remote from (e.g., in the same room, in the same building, in a separate building) the sensing system 100.

[0088] The sensing system 100 can include a fluid injection device 112 that is configured to couple to the insertion sensing device 104. The fluid injection device 112 can couple to the insertion sensing device 104 via a respective fluid container coupling unit 126 and a insertion device coupling unit 108. The insertion device coupling unit 108 and / or the fluid container coupling unit 126 can couple to each other via Luer connections. In some embodiments, the insertion device coupling unit 108 and the fluid container coupling unit 126 couple together via friction fit, screw fit, snap fit, and / or another fit type. The fit type may allow for manual couplingand / or decoupling of the insertion sensing device 104 to and / or from the fluid injection device 112. In some embodiments, the insertion sensing device 104 and the fluid injection device 112 arc configured to couple to one another along the fluid axis 148. Additionally or alternatively, the fluid injection device 112 (e.g., using the fluid actuator 122) may be configured to drive fluid out of the fluid outlet 114 along the fluid axis 148. In some embodiments, the fluid injection device 112 is substantially radially symmetric about the fluid axis 148.

[0089] FIG. 1C schematically shows an example insertion sensing device 104 having a physiological sensor 120 (or a portion thereof) at or near a tip of the cannula 128, according to some implementations. The physiological sensor 120 may include any of the sensors and / or include any of the functionality described above with respect to FIGS. 1A-1B. Inclusion of the physiological sensor 120 at or near the tip of the cannula 128 can allow for direct sensing of the target physiological parameter(s) of the interior of the patient tissue. For example, the physiological sensor 120 can include a temperature sensor that, when inserted into the interior of the patient tissue, can directly sense the temperature, which may be more rapid and / or accurate than a similar temperature sensor located only within the sensing unit 116. As another example, a physiological sensor 120 that includes a pressure sensor at the tip of the cannula 128 can allow for direct sensing of the pressure within the interior of the patient tissue. This can result in more accurate and / or more rapid pressure readings. For example, if the pressure sensor is inserted into a patient eye to measure IOP, the IOP can be measured without needing to wait for the closed fluid system to reach equilibrium. Instead, the pressure sensor can interface directly with the interior of the patient tissue. This may be particularly beneficial in the context of measuring blood pressure, IOP, compartment pressure, epidural tissue pressure, and / or respiratory pressure (e.g., within a nasal passage) or sinus pressure.

[0090] Inclusion of the physiological sensor 120 (or a portion thereof) at or near the tip of the cannula 128 can allow for potentially greater options of physiological sensors or even sensor types. For example, as noted above, a blood oxygen sensor may include both a light source (e.g., a plurality of light sources) and a photodetector. Accordingly, some embodiments include a portion of the physiological sensor 120 near the tip of the cannula 128 while the light source can be disposed in the sensing unit 116. In this way, a blood sample that is within an interior of the cannula 128 can be sensed for blood oxygen level.

[0091] In some embodiments, it may be beneficial to arrange the physiological sensor 120 at the tip of the cannula 128 and have the fluid outlet from the cannula interior 178 via a sidewall outlet 182, as shown in FIG. ID. FIG. ID schematically shows a detail of an example tip of a cannula with a physiological sensor, according to some implementations. As shown in FIG. ID, the fluid exiting (or entering) the cannula 128 can do so via a side of the cannula 128 (e.g., off-axis). Such an arrangement may be in addition or alternative to an outlet disposed along the fluid axis 148 and / or at a proximal tip of the cannula 128. The arrangement shown in FIG. ID can allow for the physiological sensor 120 to be at the tip of the cannula 128 without substantially increasing the effective outer diameter of the cannula 128.

[0092] This arrangement may be particularly beneficial when the cannula 128 is to be inserted through a patient tissue, such as skin or eye tissue. Smaller incisions can reduce patient pain, fluid (e.g., blood) loss, and long-term complications from the incisions. Additionally or alternatively, smaller incisions may promote faster healing of the incision site. Moreover, a smaller outer diameter may incentivize adoption by practitioners who may be used to a particular outer diameter of the cannulas in their procedures. For example, an incision in cataract surgeries may be less than about 4 mm, and a commonly used 27-gauge cannula may have an outer diameter of about 0.413 mm. Effectively larger cannula diameters may result in more damage to the incision site as the practitioner seeks — sometimes effectively, sometimes not effectively — to insert the cannula 128 through the incision, perhaps multiple times. Accordingly, in some embodiments the physiological sensor 120 has an outer diameter (OD) no greater than an outer diameter of the cannula 128. The OD of the pressure sensor can be different, such as the ODs listed above for the cannula 128.

[0093] In some embodiments, a physiological sensor 120 in the arrangement shown in FIG. ID can include a pressure sensor, such as a MEMS pressure sensor, a fiber optic pressure sensor, and / or another pressure sensor using a thin membrane or diaphragm, as described herein. For example, some embodiments can include a MEMS pressure sensor that is less than about 0.5 mm thick (e.g., S Series sensor made by Merit Medical Systems), less than about 0.33 mm thick (e.g., integrated sensor made by Millar), less than about 0.1 mm thick (C39 sensor made by TDK Electronics), or even less than about 0.09 mm thick (e.g., P2490 sensor made by AZO Sensors). Some embodiments can include a fiber optic pressure sensor having a fiber diameter of less thanabout 0.1 mm and a tip of less than about 0.22 mm (e.g., made by OpSens). Some embodiments include a tip having a diameter of less than about 0.1 mm.

[0094] In embodiments where the physiological sensor 120 is at the distal tip of the cannula 128, such as shown in FIG. ID, the physiological sensor 120 may be powered via one or more electrical leads 186 disposed along a sidewall of the cannula 128. Additionally or alternatively, some embodiments may include data connections (e.g., electrical, optical) to the controller 124 disposed along the sidewall of the cannula 128 and connect to the controller 124 and / or the power source 140. In such embodiments, the electrical and / or data connections may be coated in an electrically and / or optically insulative material. The insulative material may be configured to prevent electrical power / signal and / or optical signal from leaking into the interior of the patient tissue. In some embodiments, the insulative material comprises a biocompatible material, such as one described herein.

[0095] In some embodiments, such as those where the outer diameter of the cannula 128 is not a restriction, the physiological sensor 120 may be disposed along a sidewall of the cannula 128 (e.g., as shown in FIG. 1C). In such embodiments, power and / or data connections may run along a sidewall of the cannula 128 to the controller 124 and / or to the power source 140.

[0096] FIG. IE shows an example sensing system 100 having an insertion device 102 and a fluid injection sensing device 130. The insertion device 102 and the fluid injection sensing device 130 may be configured to be coupled to one another. The fluid injection sensing device 130 can include a sensing unit 116. Although particular detail has been provided to the example of the medical device 300 below, any one or combination of features and / or details described with regard to the medical device 300 can apply to any fluid injection sensing device embodiment (e.g., the fluid injection sensing device 130). For example, the medical device 300 may be characterized as a fluid injection sensing device. The insertion device 102 can include one or more features of the insertion sensing device 104 described above. Additionally or alternatively, the fluid injection sensing device 130 can include one or more features of the fluid injection device 112 and / or of the sensing unit 116 described above. For example, the fluid injection sensing device 130 can include a fluid actuator 122 that is configured to eject fluid out of the injection device fluid channel 138 via the fluid chamber 118. Additionally or alternatively, the fluid injection sensing device 130 can be configured to inject fluid into the insertion device 102 via the fluid inlet 106.

[0097] The fluid injection sensing device 130 can include an elongate fluid injection device coupling unit 132 (e.g., relative to that of the fluid injection device 112) to provide space for the sensing unit 116. The fluid injection sensing device 130 can include a barrel flange and / or a plunger flange to allow convenient manipulation by a practitioner of the fluid injection sensing device 130.

[0098] The sensing unit 116 of the fluid injection sensing device 130 can include one or more features as described above. Additionally or alternatively, the features of the sensing unit 116 of the fluid injection sensing device 130 may be adapted for the unique features of the fluid injection sensing device 130. For example, the sensing unit 116 can be attached or otherwise coupled to the fluid injection device coupling unit 132. One or more physiological sensors of the physiological sensor 120, the controller 124, the pull-tab 144, the power source 140, and / or the user interface 136 may be disposed at a radially different distance from the fluid axis 148. For example, one or more of these elements may be stacked on one another in a radial direction. Such a compact arrangement can allow for easier manufacture of the sensing unit 116. Additionally or alternatively a radially compact arrangement can allow for one or more elements to be combined into a separate module that may be removable from the rest of the sensing unit 116. In some embodiments, the sensing unit 116 is configured to be removably attached to the insertion device coupling unit 108. This may be valuable, for example, if the sensing unit 116 is to be reused from procedure to procedure where one or more other elements of the fluid injection sensing device 130 (e.g., the rest of the fluid injection sensing device 130 aside from the sensing unit 116) can be disposable. In some embodiments, the whole fluid injection sensing device 130 (e.g., including the sensing unit 116) is configured to be disposable.

[0099] In some embodiments, one or more of these elements may be disposed circumferentially about the fluid axis 148. For example, the physiological sensor 120 and the controller 124 may be disposed at nearly the same radial distance from the fluid axis 148. Circumferential disposition of elements about the fluid axis 148 can improve ergonomics of the fluid injection sensing device 130 for a practitioner. Additionally or alternatively, it may reduce effective outer diameter of the fluid injection sensing device 130.

[0100] The physiological sensor 120 can include one or more sensors. The physiological sensor 120 can be configured to be in fluid communication with the injection device fluid channel 138. This may allow the physiological sensor 120 to directly sense one or morephysiological parameters of the fluid therein and / or of the fluid in the fluid chamber 118. For example, the physiological sensor 120 may be configured to sense a fluid pressure of the fluid within the fluid chamber 118 once the fluid has reached equilibrium. The physiological sensor 120 can include one or more types and / or one or more physiological sensors, as described above with respect to FIGS. 1A-1D.

[0101] FIG. IF shows an example sensing system 100 having an insertion device 102, an intermediate sensing device 150, and a fluid injection device 112. The sensing system 100 may have only one or two of these elements. The insertion device 102 and / or the fluid injection device 112 may be configured to couple to the intermediate sensing device 150. For example, the insertion device coupling unit 108 of the insertion device 102 may be configured to couple to a distal end of an intermediate coupling unit 152 of the intermediate sensing device 150. Additionally or alternatively, the fluid container coupling unit 126 of the fluid injection device 112 may be configured to couple to a proximal end of the intermediate coupling unit 152.

[0102] The intermediate sensing device 150 can include a sensing unit 116. Although particular detail has been provided to the example of the medical device 300 below, any one or combination of features and / or details described with regard to the medical device 300 can apply to any intermediate device embodiment (e.g., the intermediate sensing device 150). The intermediate sensing device 150 can include one or more features of the insertion sensing device 104 and / or the fluid injection sensing device 130 described above, where appropriate. How the features of the insertion sensing device 104 and / or the fluid injection sensing device 130 can be applied to the intermediate sensing device 150 will be clear to one of ordinary skill in the art, so the specifics are not repeated here in an effort to avoid needless repetition. Additionally or alternatively, the intermediate sensing device 150 can include one or more features of the sensing unit 116 described above. For example, the intermediate sensing device 150 can include an intermediate device fluid channel 154 that is configured to be in fluid communication with the fluid channel 110 and / or the fluid chamber 118. The intermediate device fluid channel 154 may be configured to contain no more than about 2 mL, and in some embodiment no more than 1 mL, of fluid at one time.

[0103] The sensing unit 116 of the intermediate sensing device 150 can include one or more features as described above. The features of the sensing unit 116 of the intermediate sensing device 150 may be adapted for the unique features of the intermediate sensing device 150. Forexample, the sensing unit 116 can be attached or otherwise coupled to the intermediate sensing device 150. One or more physiological sensors of the physiological sensor 120, the controller 124, the pull-tab 144, the power source 140, and / or the user interface 136 may be disposed within the intermediate sensing device 150 at a radially different distance from the fluid axis 148. For example, one or more of these elements may be stacked on one another in a radial direction. Such a compact arrangement can allow for easier manufacture of the sensing unit 116. Additionally or alternatively a radially compact arrangement can allow for one or more elements to be combined into a separate module that may be removable from the rest of the sensing unit 116. In some embodiments, the sensing unit 116 is configured to be removably attached to the insertion device coupling unit 108. This may be valuable, for example, if the sensing unit 116 is to be reused from procedure to procedure where one or more other elements of the intermediate sensing device 150 (e.g., the rest of the intermediate sensing device 150 aside from the sensing unit 116) can be disposable. In some embodiments, the whole intermediate sensing device 150 (e.g., including the sensing unit 116) is configured to be disposable. In some embodiments, the intermediate sensing device 150 is reusable but the insertion device 102 and / or the fluid injection device 112 are configured to be disposable.

[0104] In some embodiments, one or more of these elements may be disposed circumferentially about the fluid axis 148. For example, the physiological sensor 120 and the controller 124 may be disposed at nearly the same radial distance from the fluid axis 148. Circumferential disposition of elements about the fluid axis 148 can improve ergonomics of the insertion intermediate sensing device 150 for a practitioner. Additionally or alternatively, it may reduce effective outer diameter of the intermediate sensing device 150.

[0105] The physiological sensor 120 can include one or more sensors. The physiological sensor 120 can be configured to be in fluid communication with the intermediate device fluid channel 154. This may allow the physiological sensor 120 to directly sense one or more physiological parameters of the fluid therein, of the fluid in the fluid chamber 118, and / or fluid in the fluid channel 110. For example, the physiological sensor 120 may be configured to sense a fluid pressure of the fluid within the fluid chamber 118 and / or within the fluid channel 110 of the insertion device 102 once the fluid has reached equilibrium. The physiological sensor 120 can include one or more types and / or one or more physiological sensors, as described above with respect to FIGS. 1A-1D.

[0106] FIG. 2 schematically shows an example insertion device 102 having a relief valve 160, according to certain implementations. The relief valve 160 can be configured to prevent a delivery of a pressure beyond a threshold pressure out of the insertion device 102 (e.g., via the cannula 128).

[0107] The insertion device 102 can include a pressure plate 164, a relief valve 160, a resilient member 156, a relief fluid chamber 168, and / or a relief outlet 172. Additionally or alternatively, the insertion device 102 can include one or more features described above with regal’d to the insertion sensing device 104. For example, the insertion device 102 can include a insertion device coupling unit 108 configured to couple (e.g., via the insertion device coupling unit 108) to a fluid injection device 1 f 2, a fluid injection sensing device 130, and / or an intermediate sensing device 150.

[0108] Fluid can enter the insertion device 102 via the fluid inlet 106. Fluid entering the insertion device coupling unit 108 can flow through a main channel but be redirected to the relief outlet 172 if a fluid pressure of the fluid delivered into the fluid inlet 106 is beyond a threshold fluid pressure. In some embodiments, the threshold fluid pressure is adjustable (e.g., manually adjustable) using an adjustment element (not shown). The fluid may come from a fluid source, such as the intermediate sensing device 150, fluid injection device 112, and / or fluid injection sensing device 130 described above. If the fluid pressure injected into the fluid channel 110 is beyond the fluid pressure, the fluid may cause the relief valve 160 to contact the pressure plate 164 (e.g., to open the relief valve), thus driving additional fluid away from a distal end of the cannula 128 and into the relief outlet 172. The resilient member 156 can automatically drive the relief valve 160 to contact the pressure plate 164 once the target pressure has been applied. The resilient member 156 may be coupled to the relief valve 160 and / or to the pressure plate 164.

[0109] In some embodiments, the fluid pressure may come from drawing fluid into the insertion device 102 via the cannula 128. In such embodiments, it may be beneficial to open the relief valve 160 by closing the main fluid chamber so that the fluid pressure does not drop below a threshold pressure.

[0110] FIGS. 3A-3C show various views of an example insertion sensing device 104, according to certain implementations. As shown, the user interface 136 includes a display screen. The display screen may include a touch screen interface. FIG. 3A shows a perspective view of the insertion sensing device 104. FIG. 3B shows a side view of the insertion sensing device 104 ofFIG. 3 A. FIG. 3C shows a top view of the insertion sensing device 104 of FIG. 3 A. The Luer threads can be seen at the proximal end of the insertion sensing device 104. Structural ribs of the insertion sensing device 104 can be seen running parallel to the fluid axis.

[0111] As shown in FIG. 3C, the cannula 128 may include one or more bends. For example, in some embodiments (e.g., in embodiments with a more rigid cannula 128), the cannula 128 can include an axial portion and an inclined portion. The axial portion of the cannula 128 may extend from the insertion device coupling unit 108 along the fluid axis 148. The inclined portion can form an angle 0 subtending the axial portion and the inclined portion.

[0112] FIG. 4A shows an example fluid injection sensing device 130, according to some implementations. FIG. 4B shows a cross-section of a detail view of the fluid injection sensing device 130. The fluid outlet 114 of the fluid injection sensing device 130 is disposed within a portion of the fluid injection device coupling unit 132. The Luer threads of the fluid injection device coupling unit 132 can be seen. The fluid injection sensing device 130 shown in FIG. 4A may be referred to as a “syringe-type” medical device. Other examples of syringe-type medical devices include those described with respect to FIGS. 6A-6C and FIGS. 8A-8D.

[0113] FIGS. 5A-5C show various views of an example intermediate sensing device 150, according to some implementations. FIG. 5A shows a top view thereof, FIG. 5B shows a side view thereof, and FIG. 5C shows a side view cross section thereof.

[0114] FIGS. 6A-6C show various views of an example fluid injection sensing device 230, according to some implementations. The fluid injection sensing device 230 can include a fluid chamber 218, a fluid actuator 222, a fluid injection sensing device coupling unit 232, a fluid outlet 214, a sensing unit 216, and an interface control unit 226. The interface control unit 226 can include a user interface 236 and / or one or more interface control elements 248.

[0115] The interface control unit 226 can be configured to be removably coupled to the sensing unit 216. The interface control unit 226 can have a housing that couples to the fluid chamber 218 via a coupling interface 208 (shown in FIG. 6C). The coupling interface 208 can include a guiding interface for convenient orientation of the interface control unit 226 relative to the sensing unit 216 and / or relative to the fluid chamber 218 during manual coupling of the sensing unit 216 with the interface control unit 226. The coupling interface 208 may include a guide rail or other guide track. A corresponding receiving element of the interface control unit 226 may uniquely couple to the coupling interface 208 in only a specified orientation. This correspondencebetween the coupling interface 208 and the receiving element of the interface control unit 226 can enhance the safety of the fluid injection sensing device 230 by reducing the chance of malfunction of the fluid injection sensing device 230 and / or of any elements thereof.

[0116] The interface control elements 248 can allow a user to interact with (e.g., provide user input into) the fluid injection sensing device 230. As noted above, the interface control elements 248 can be configured to allow a user to access one or more physiological parameters sensed by the fluid injection sensing device 230, modify one or more parameter settings, and / or otherwise modify outputs from the user interface 236 by interacting with these control elements. For example, the user may modify the physiological parameter settings by changing one or more control parameters using a corresponding interface control element. In some embodiments, the interface control elements 248 include one or more indicators configured to provide user feedback. The indicators may include visual (e.g., light), tactile (e.g., haptic), and / or auditory indicators. The user interface 236 can include one or more features of the user interface 136 described above. For example, the user interface 236 may include a display screen and / or a touch screen interface.

[0117] FIG. 6B shows the fluid injection sensing device 230 of FIG. 6A, but with the housings of the interface control unit 226 and the sensing unit 216 removed. FIG. 6C shows a cross-sectional view of the fluid injection sensing device 230 of FIG. 6A. As shown, the interface control unit 226 can include a power source 240. The power source 240 may include a battery such as a lithium battery. In some embodiments, the power source 240 includes a rechargeable lithium polymer battery. The power source 240 may be recharged via a charging interface 206 (shown in FIG. 6C). The charging interface 206 may be included in the interface control unit 226. For example, the interface control unit 226 may be decoupled from the sensing unit 216 (e.g., along the coupling interface 208) and conveniently charged. The charging interface 206 can include a USB, lightning, micro-USB, USB Type C, USB Type A, and / or a wireless charging port.

[0118] The interface control unit 226 can include a user interface controller 244. The user interface controller 244 can be configured to take input from the one or more interface control elements 248 and incorporate it into the system. Additionally or alternatively, the user interface controller 244 can receive output from the sensing unit controller 242 and / or the physiological sensor 220 to convert one or more physiological readings to a display of corresponding physiological parameters. The user interface controller 244 can include a wireless transceiver configured to communicate with a remote user interface (not shown). For example, the userinterface controller 244 can be configured to transmit physiological parameter data and / or corresponding display data to a remote user interface via, for example, Wi-Fi and / or Bluetooth. The user interface controller 244 can include a microcontroller configured to convert data from one form to another. The microcontroller can include an ESP32 module.

[0119] The sensing unit 216 can include the physiological sensor 220 and the sensing unit controller 242. The physiological sensor 220 can be fluidly protected via one or more O-rings, as shown in FIG. 6C. The sensing unit controller 242 may include one or more features of the controller 124 described above. Additionally or alternatively, the physiological sensor 220 can include one or more features of the physiological sensor 120 described above. The physiological sensor 220 can transmit sensed data to the user interface controller 244. In some examples, the physiological sensor 220 communicates with the user interface controller 244 via digital (e.g., not analog) data. The sensing unit 216 can be configured to couple to the interface control unit 226 via a unit interface 210. The unit interface can include a magnetic interface. The magnetic interface can bias the unit interface such that the sensing unit 216 and the interface control unit 226 are biased in an electrically connected configuration. For example, the sensing unit 216 and the interface control unit 226 can couple to one another via MagSafe electrical connectors. In some embodiments, the sensing unit 216 will not operate unless and until the interface control unit 226 is coupled thereto.

[0120] The fluid chamber 218 and the sensing unit 216 can be configured to be disposable. Additionally or alternatively, the interface control unit 226 can be configured to be reusable. Thus, ergonomic coupling between the sensing unit 216 and the interface control unit 226 is preferred.

[0121] As the fluid actuator 222 is manually operated by a user (e.g., a practitioner), the fluid actuator 222 can push fluid within the fluid chamber 218 through the injection device fluid channel 238 and out of the fluid outlet 214. The fluid outlet 214 may be coupled to another device, such as an insertion device 102, an insertion sensing device 104, and / or an intermediate sensing device 150. The fluid within the fluid chamber 218 and the injection device fluid channel 238 may come to hydrostatic equilibrium. At equilibrium, the physiological sensor 220 can sense the one or more physiological parameters (e.g., fluid pressure) associated with the fluid. For example, the physiological sensor 220 may be able to measure the intraocular pressure (IOP)within a patient’s eye, a compartment pressure within a patient’s body part, and / or an epidural tissue pressure.

[0122] FIG. 7 shows an example method 700 of displaying one or more physiological parameters. The method 700 may be performed by any system described herein, such as the one or more controllers (e.g., sensing unit 116, the sensing unit 216, the user interface controller 244 the medical device 300, the controller 397, etc.). At block 704 the system can receive, from a physiological sensor, the physiological signal. At block 708, the system can convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue. At block 712 the system can cause the physiological reading to be transmitted to a display interface. At block 716 the system can cause the display interface to display the physiological parameter based on the physiological reading. Additional and / or fewer steps may be implemented in the method 700 than shown.

[0123] FIG. 8A shows an exploded view of an example medical device 300, according to some implementations. Although reference will be made to a pressure device and to a syringetype device throughout the discussion of FIGS. 8A-8D, these features are described for illustrative purposes. Other sensors described herein can be incorporated in place of or in addition to the pressure sensor. Additionally or alternatively, the features described with respect to a syringe-type device can similarly apply to embodiments of an insertion (e.g., cannula), intermediate, and / or implantable medical device. For example, any feature and / or detail described above with respect to the sensing system 100, the insertion device 102, the fluid injection sensing device 130, the intermediate sensing device 150, the fluid injection sensing device 230, etc. can be incorporated into the medical device 300. The details, if not repeated here, are omitted simply to avoid unnecessary repetition. Similarly, any feature described with regard to the medical device 300 can be included in embodiments of the sensing system 100, the insertion device 102, the fluid injection sensing device 130, the intermediate sensing device 150, and / or the fluid injection sensing device 230.

[0124] The medical device 300 shown can include a fluid chamber 304, a plunger 324, and / or a stopper 372. In some embodiments, the medical device 300 includes a finger flange 358. The fluid chamber 304 can be disposed along a fluid axis 306. The fluid chamber 304 may be configured to contain fluid (e.g., liquid) for injection and / or pressure measurement. Although themedical device 300 is described as a pressure sensing device, in some examples the medical device 300 can additionally or alternatively sense other physiological information described herein.

[0125] The fluid chamber 304 can include a syringe barrel. The fluid chamber 304 may be configured to hold up to 1 mL of fluid, up to 3 mL of fluid, up to 5 mL of fluid, up to 10 mL of fluid, up to 20 mL of fluid, up to 50 mL of fluid, any value therein, or fall within a range having any values therein as endpoints. For example, in some embodiments the fluid chamber 304 can hold up to 5 mL. The fluid chamber 304 includes a sidewall 308, which defines the outer structure of the chamber. The sidewall 308 can provide mechanical integrity and / or fluid containment. At the proximal end, a chamber flange 312 of the fluid chamber 304 can be configured to facilitate manipulation and / or controlled actuation of the plunger 324 during use. In some examples, the chamber flange 312 may be configured to receive a finger flange 358 thereon. The fluid chamber 304 can include a coupling portion 316 located at the distal end of the fluid chamber 304. The coupling portion 316 may include Luer threads that are configured to couple to a cannula, a needle, a catheter, and / or another medical device component. The coupling portion 316 may include a fluid channel 320 through which fluid can pass from the fluid chamber 304 out of the medical device 300, such as into said cannula, needle, catheter, and / or other medical device component. The fluid channel 320 can be in fluid communication with a fluid inlet of another medical device component. This coupling portion 316 can allow releasable attachment of the medical device 300 to a patient interface (e.g., cannula, needle, catheter).

[0126] The plunger 324 can include a plunger housing 328 and / or various electronics described herein. The plunger 324 can be configured to be movably disposed within the fluid chamber 304 along a fluid axis 306. The plunger housing 328 can include a plunger body 334, a plunger neck 350, and / or a plunger head 354. The plunger body 334 can engage with an inner surface of the sidewall 308 to maintain a fluid-tight (e.g., liquid tight) seal. For example, the fluid- tight seal may be able to withstand fluid pressures of at least 10 psi. If the fluid-tight seal can withstand pressures greater than 10 psi, it may be too difficult for a practitioner to easily expel fluid from the fluid chamber 304 without upsetting accuracy of use. Less than 10 psi, and the fluid- tight seal may not be strong enough to withstand normal human pressures, particularly when a cannula or other fluidics element is attached to the coupling portion 316 of the plunger 324. Along its exterior, the plunger body 334 can include at least one track 338, such as a first track 338a and / or a second track 338b. The track 338 can facilitate guided axial movement and / or preventrotation of the plunger 324 relative to the fluid chamber 304 during actuation. The plunger housing 328 can additionally or alternatively include a display aperture 342 configured to allow a user to view a displayed pressure (e.g., IOP) measurement (e.g., in real time) while manipulating the device.

[0127] At its distal end, the plunger 324 can terminate in a plunger head 354. The plunger head 354 can interface with a stopper 372, such as to form a sealing mechanism. The plunger neck 350 can be positioned between the plunger body 334 and the plunger head 354. The plunger neck 350 can form a circumferential recess that enables secure coupling of the stopper 372 to the plunger head 354. The stopper 372 can include a resilient material, such as silicone rubber, thermoplastic elastomer (TPE), poly isoprene, butyl rubber, and / or fluoroelastomer. The stopper 372 can have a durometer configured to balance fluid seal, lubrication, durability, and / or ease of manipulation of the medical device 300. For certain embodiments using viscous liquids or biological materials, a durometer of between about 40-50 Shore A is preferred. In some embodiments where, for example, general saline or other relatively inert fluids may be used, a durometer of between about 50-60 Shore A is preferred. In embodiments where higher pressures and / or where more precise, consistent sealing is beneficial, durometers of between about 60-70 Shore A (or greater) may be used. In some embodiments, a durometer of greater than 50 Shore A is appropriate, which helps balance both durability and seal reliability.

[0128] With reference to FIG. 8D, which shows a cross section of a portion of the medical device 300, the stopper 372 can include a distal surface 376 that is configured to directly contact the fluid contained within the fluid chamber 304. Additionally or alternatively, the stopper 372 can include a stopper aperture 378. The stopper aperture 378 may be configured to accommodate a pressure sensor 388 therein. Although reference to a pressure sensor is provided here as an example, any other physiological sensor may be incorporated additionally or in the place of the pressure sensor 388. The stopper 372 may include a circumferential flange 382, such as at a proximal end of the stopper 372. The circumferential flange 382 can improve a stability of coupling of the stopper 372 to the plunger neck 350 and / or the plunger head 354. The coupling between the stopper 372 and the plunger neck 350 and / or the plunger head 354 can form a second fluid seal to prevent, for example, fluid ingress into an interior of the plunger housing 328 during normal pressures. For example, the pressure sensor 388 may be configured to maintain normal operation or functionality (e.g., not be permanently damaged) for pressures below 40 psi at the pressuresensor 388. Tn some embodiments, if the pressure sensor 388 can withstand pressures greater than 40 psi and maintain operation, the pressure sensor 388 may fail in some other metric, such as a necessary level of precision, an overly demanding electrical budget relative to the small form factor of the medical device 300, or some other limitation. The second fluid seal can extend at least 350° about the fluid axis 306. A second fluid seal that extends less than 350° about the plunger neck 350 may not provide sufficient structural integrity of the plunger neck 350, the second fluid seal, and / or of the flexible PCB 394. Additionally or alternatively, in some embodiments, if the second fluid seal extends greater than about 350° about the plunger neck 350 may prevent access of an electronic component into the plunger head 354 from the plunger body 334. A second fluid seal that extends at least than 350° can help prevent leakage between the fluid chamber 304 and the interior of the plunger 324. In some embodiments, the stopper 372 can be configured to be in contact with one or more of the head 354 of the plunger housing 328, a proximal interior surface 384 of the stopper 372, and / or a distal interior surface 386 of the stopper 372. In some embodiments, the stopper 372 may be configured to be in simultaneous contact with each of these elements.

[0129] With continued reference to FIG. 8A, a finger flange 358 can be positioned about the chamber flange 312. The finger flange 358 can provide a stable grip point for user actuation of the medical device 300. The finger flange 358 can include a finger flange 358. The finger flange 358 can be formed of one or more finger flange portions 358a, 358b. The finger flange portions 358a, 358b can snap together using a snap fit. The finger flange 358 can extend beyond an extension of the chamber flange 312. The finger flange 358 can house a magnet 362, which can interact with a Hall effect sensor 391. The Hall effect sensor 391 and / or other proximity sensor can be disposed within the plunger housing 328, such as on a rigid printed circuit board (PCB) 395. Additionally or alternatively the medical device 300 can include one or more other calibration sensors, such as a temperature sensor, a humidity sensor, a gyroscope, an optical sensor, a load cell, and / or other calibration device. The calibration sensor can sense data that can be used to correct an offset of the pressure sensor 388 (and / or other physiological sensor) of the medical device 300. The sensed data may be calibration data, such as liquid calibration data. The liquid calibration data can be useful in correcting one or more errors inherent in liquids. For example, the Hall effect sensor 391 (e.g., in combination with the magnet 362) can be configured to generate proximity data. The proximity data can allow the controller 397 to determine the position of theplunger 324 relative to the fluid chamber 304. This can provide an indication of a height of a fluid (c.g., liquid) column that may provide a pressure reading distortion. The size constraints of the medical device 300 have previously made incorporation of the elements described herein into a compact and functional fluid device. For example, only recently have innovations in physiological (e.g., pressure) sensor and other sensor technology (e.g., calibration sensors) allowed for such a compact integration of the unique combination of elements described herein — particularly into a syringe-like device that includes a stopper, plunger, and fluid chamber — together into a common housing that can sensitively and accurately measure physiological parameters (e.g., pressure) without sacrificing functionality and reliability.

[0130] The medical device 300 can include an accelerometer 392. The Hall effect sensor 391 and the accelerometer 392 can work together to determine the orientation of the medical device 300 relative to Earth’s gravitational field. The Hall effect sensor 391, housed within the plunger housing 328, can detect the position of the plunger 324 by measuring the distance between itself and the magnet 362 housed within the finger flange 358. This measurement provides data on how far the plunger has been depressed, which directly correlates to the amount of liquid within the fluid chamber 304. However, the effective fluid column height within the cannula is affected by the orientation of the medical device 300. The fluid column can distort pressure readings within the common fluid chamber due to hydrostatic effects. To correct for this distortion, the accelerometer 392 detects an angle 0 of the device relative to vertical by measuring gravitational acceleration along multiple axes (e.g., x, y, and z). This orientation data is then used to compute the effective fluid column height.

[0131] The effective fluid column height heff is calculated based on the actual liquid column height h within the fluid chamber and the tilt angle 0. When the device is perfectly vertical (0 = 0°), the full height of the liquid column contributes to the pressure reading. However, when the device is tilted at an angle 0, the vertical component of the liquid column contributing to the pressure is given by:

[0132] This correction is necessary because the hydrostatic pressure exerted by the liquid is proportional to its vertical height rather than its absolute length along the cannula. The controller 397 receives data from both the Hall effect sensor 391 (which provides the total fluidcolumn height h) and the accelerometer 392 (which provides the tilt angle 0) to computeThe corrected pressure reading is then determined using:

[0133] where PmeaSured isthe raw pressure reading from the pressure sensor 388, p is the fluid density, and g is the acceleration due to gravity. By applying this correction, the device ensures that the final pressure reading is not distorted by variations in orientation, providing an accurate pressure reading regardless of how the user holds the device.

[0134] Additionally or alternatively, the finger flange 358 can include a finger flange protrusion 368. The finger flange protrusion 368 can be oriented inward toward the plunger 324. The finger flange protrusion 368 can engage with a corresponding track 338 to constrain rotational movement. This can ensure consistent axial motion of the plunger 324. In some embodiments, the medical device 300 includes a plurality of finger flange protrusions 368a, 368b that can couple to respective tracks 338a, 338b. The track 338 can be disposed axially to prevent rotation of the plunger 324 relative to the fluid chamber 304 and / or relative to the finger flange 358. This constrained axial movement can ensure that a distance measurement between the magnet 362 and the Hall effect sensor 391 results in reliable fluid column data.

[0135] The medical device 300 can include a pressure sensor 388 and / or other physiological sensor described herein. Although reference will be made to the pressure sensor 388, one or more other physiological sensors may be disposed in place of or additionally to the pressure sensor 388. The pressure sensor 388 can be positioned within the stopper aperture 378. For example, a pressure sensor face 390 of the pressure sensor 388 can be oriented such that a normal of the pressure sensor face 390 is parallel to the fluid axis 306. This arrangement allows the sensor to measure fluid pressure within the fluid chamber 304 and the fluid channel 320. In some embodiments, the pressure sensor 388 is oriented as shown, for example, in FIG. 4B or FIG. 6C. The pressure sensor 388 can be positioned within the stopper 372 such that is in contact with the proximal interior surface 384 of the stopper. The pressure sensor can be configured to be in fluid communication with the fluid channel 320, such that any variation in pressure within the fluid chamber 304 (e.g., any variation of pressure within a common chamber that may include an interior of patient, such as an interior of a tissue) can be accurately sensed. The pressure sensor face 390 can be recessed within the aperture 378 of the stopper 372, allowing a column of liquid to form within the aperture at the face of the pressure sensor. The aperture 378 can have a height (e.g.,measured along the fluid axis) of less than about 1 mm, less than about 2 mm, less than about 2 mm, less than about 2 mm, less than about 2 mm, less than about 2 mm, less than about 2 mm, less than about 2 mm, less than any value therein, or fall within a range having endpoints therein. For example in some embodiments, the height is less than about 5 mm. A heigh of less than 5 mm will significantly reduce the accumulation of air bubbles within the aperture 378. Thus, having a height of less than 5 mm will increase the accuracy of the medical device 300.

[0136] In some embodiments, this liquid column may be shorter than a column of liquid that the calibration sensor (e.g., the Hall effect sensor 391 and / or the accelerometer 392) are configured to compensate for, which may include a fluid column extending from the pressure sensor face 390 to a distal end of the medical device 300, to a distal end of a coupled cannula, to a distal end of a needle or catheter, and / or to a distal end of an interior of a tissue of a patient. The pressure sensor 388 can interact with the fluid at the pressure sensor face 390 to measure a pressure (e.g., IOP) of a common chamber pressure that includes the fluid chamber 304 and the interior of the patient tissue. The pressure sensor 388 may be configured to measure pressures within a range of 0 to 100 mmHg to a precision of at least one-tenth of a mmHg. The pressure sensor 388 may measure an absolute pressure. In some embodiments, the pressure sensor 388 measures a relative pressure relative to a pressure outside the medical device 300 (e.g., atmospheric pressure). The pressure sensor 388 may be configured to measure an analog or digital pressure signal.

[0137] The pressure sensor 388 may be coupled to a flexible PCB 394. The flexible PCB 394 may couple to a rigid PCB 395. The rigid PCB 395 can be partially or fully disposed within the plunger housing 328. The rigid PCB 395 can house various electronics, such as the Hall effect sensor 391, the accelerometer 392, the power source 393, the display interface 344, a PCB switch 398, the controller 397. In some embodiments the rigid PCB 395 includes the pressure sensor 388. The rigid PCB provides a stable platform for the electronic components. For example, the Hall effect sensor 391 can be placed on the rigid PCB 395 to ensure reliable interaction with the magnet 362 housed in the finger flange 358.

[0138] The flexible PCB 394 can interconnect various components within the medical device 300. The flexible PCB 394 can be bent and / or routed around other components without causing damage or interference. The flexible PCB can include the pressure sensor 388 and can allow for functional installment of the pressure sensor 388 within the medical device 300 (e.g., within the plunger 324 and / or stopper 372.

[0139] The controller 397, housed within the plunger housing 328, processes signals from the pressure sensor 388, the Hall effect sensor 391, and an accelerometer 392 to generate a corrected sensor reading (e.g., as described above regarding the corrected pressure reading). This pressure reading can be then transmitted to the display interface 344. For example, the controller 397 may be in communication with a wireless data interface (not shown). The controller 397 can instruct the wireless data interface to send and / or receive signals from a remote computing device. Examples of such data interfaces and / or remote computing devices are further described with respect to FIG. 10. Additionally or alternatively, the display of values may on a remote computing device, such as a smart phone, hospital computer, the cloud, or other devices described herein (e.g., with respect to FIG. 10). The controller 397 may include a microcontroller and can serve as the central processing unit of the medical device 300. The controller 397 may integrate data from multiple sources (e.g., sensors) to compute and / or cause to display an accurate pressure measurement. The controller 397 can be disposed within the plunger housing 328. The controller 397 can be in electrical communication with the pressure sensor 388, the Hall effect sensor 391, the accelerometer 392, the power source 393, and / or display interface 344.

[0140] The controller 397 can access calibration data such as a calibration distance, which may correspond to an expected fluid column length. For example, the expected fluid column length may be an effective height of a cannula or needle (e.g., above the pressure sensor 388) measured from a distal end of the medical device 300 (e.g., when the cannula or needle is properly coupled to the medical device 300). This calibration distance can correct for any additional fluid column height that exceeds an effective height of a fluid column within the fluid chamber 304. For example, the calibration distance may be about 0.5 cm, about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, any value therein, or fall within a range having endpoints therein. For example, in some embodiments, the calibration distance is about 2 cm. Additionally or alternatively, the controller 397 can access other calibration data, such as a calibration temperature, calibration voltage, calibration magnetic field, a calibration weight, a calibration pressure, and / or other calibration data. The calibration data may be useful in modifying the final pressure (or other physiological) reading described herein.

[0141] In some embodiments, the controller 397 can access a calibrating pressure signal from the pressure sensor 388 when the fluid chamber 304 is not in fluid communication with a target pressure chamber (e.g., an interior of a patient tissue). The calibrating pressure signalcan allow the device to establish a baseline pressure. Once the fluid chamber 304 is in fluid communication with a target fluid chamber, the controller can access a second pressure signal, which includes a preliminary pressure reading that may include a hydrostatic pressure from the fluid column. To remove the distortion of the hydrostatic artifact (e.g., due to weight of the fluid column) from the preliminary pressure reading, the controller can access proximity data from the Hall effect sensor 391 and / or an orientation signal from the accelerometer 392. The proximity data can allow the controller 397 to determine the fluid level within the fluid chamber 304. The orientation signal can be used to calculate an orientation of the fluid chamber 304. The proximity data and / or the orientation signal may be used by the controller 397 to calculate an effective fluid column height.

[0142] Using these inputs, the controller 397 can generate a corrected pressure reading by factoring in the calibrating pressure signal, the measured pressure signal, the calibration distance, the fluid level data, and / or the orientation data. This corrected value represents the actual pressure within the fluid chamber 304 and thus also within a composite chamber that include the fluid chamber 304 and the target chamber (e.g., the patient interior). At hydrostatic equilibrium, the pressure sensor 388 can sense the fluid pressure associated with a target position inside the composite chamber (e.g., an intraocular pressure (IOP) of the patient’s eye). The controller 397 can then transmit this computed pressure value to the display interface 344 in real-time, allowing the user to receive a real-time, accurate pressure reading of the target chamber. Additionally or alternatively, the controller 397 may transmit the pressure value to a remote computing system (e.g., via any wired or wireless data interface described herein). The remote computing system may be configured to display an indication of the pressure value. In some embodiments, the electronics of the medical device 300 allow for a soft latching power circuit architecture. This architecture can prevent damage to the medical device 300 during, for example, sterilization, can improve battery life, and / or maintain continuous operation during use.

[0143] FIG. 8B shows a perspective view of the medical device 300 (e.g., as seen by a user during operation) of FIG. 8A, according to some implementations. As shown, the medical device 300 includes a fluid chamber 304, a plunger 324, a finger flange 358, an actuator 346, a display interface 344, and / or a coupling portion 316.

[0144] The fluid chamber 304 can form a main body (e.g., main chamber) of the medical device 300 and may be configured to contain fluid for injection and / or pressuremeasurement. The sidewall 308 defines an outer boundary of the fluid chamber 304 and can provide structural integrity. At the proximal end of the medical device 300, the plunger 324 is designed for axial movement within the fluid chamber 304. Additionally or alternatively, the plunger 324 may be configured not to rotate about the fluid axis. The plunger 324 enables the user to control fluid displacement through manual actuation. The plunger 324 extends outward from the proximal end of the fluid chamber 304, allowing the user to press or retract the plunger 324 to manipulate fluid flow within the fluid chamber 304.

[0145] The finger flange 358 can be adjacent to the proximal end of the medical device 300 (e.g., between the fluid chamber 304 and a proximal portion of the plunger 324. The finger flange 358 can extend outward from the fluid chamber 304 to provide a grip surface, allowing the user to hold and control the medical device 300. Additionally or alternatively, the finger flange 358 can house the magnet 362.

[0146] The actuator 346 can be a button, switch, lever, and / or other movable mechanical feature that can allow user interaction with the electronic components to, for example, turn on the medical device 300 (e.g., the display interface 344). In some embodiments, the actuator 346 may serve as a mechanism to engage electronic functionalities such as pressure measurement or data transmission. For example, the actuator 346 may be coupled with one or more electronic elements of the medical device 300. For example, the actuator 346 may be operatively coupled with the PCB switch 398. Additionally or alternatively, the actuator 346 may be actuated to “zero”, tare, and / or recalibrate the medical device 300. The actuator 346 may be manipulated to achieve additional or alternative functions. For example, in some embodiments, the actuator 346 may be actuated to zero the measurement, toggle between sensor displays (e.g., from displaying pressure to displaying a parameter measured from another physiological sensor described herein), toggle between measurement types (e.g., absolute pressure vs. relative pressure), toggle a measurement unit (e.g., mmHg, kPa, psi, etc.), enter a setup and / or pairing (e.g., with Bluetooth) mode, initiate software updates, start / stop a measurement cycle, toggle a brightness of the display, initiate a factory reset, and / or power the device on / off. The response of the medical device 300 to the actuator 346 may be based on type of actuation received. For example, a short press of the actuator 346 may toggle a function while pressing and holding the actuator 346 in a particular position (e.g., depressed, extended, etc.) may toggle the device on or off. Additionally or alternatively, a double- or triple- actuation of the actuator 346 may achieve a different change in the functionalityof the medical device 300 (e.g., of one or more sensors thereof) and / or a display of the display interface 344.

[0147] The display interface 344 can be visible through the display aperture 342. In some embodiments, the display interface 344 is integrated into an external surface of the medical device 300. The display interface 344 can be configured to provide real-time feedback to the user, such as pressure (and / or other physiological parameter) readings, device status, and / or other relevant physiological data. The display interface 344 can include one or more LEDs, OLEDs, LCDs, and / or other visual indicator. Additionally or alternatively, in some embodiments the medical device 300 includes an audible indicator, such as a monotone, two-tone, and / or other auditory feedback interface. The audible indicator can indicate a quantitative measurement (e.g., of the pressure reading), a relative measurement (e.g., higher pitch corresponding to a value closer to a target physiological value, a constant pitch indicating that a target value or target range has been achieved, etc.), a functionality report (e.g., indicating a failure mode has been entered, indicating an error reading, etc.), and / or some other auditory indication. In some embodiments, the medical device 300 can additionally or alternatively provide haptic feedback, such as an indication of a physiological reading and / or any indication that may be indicated with the audible indicator. The medical device 300 may provide visual, auditory, and haptic feedback in some embodiments.

[0148] At the distal end of the fluid chamber 304, the coupling portion 316 can enable attachment to external medical components, such as a cannula, needle, and / or catheter. The coupling portion 316 may incorporate Luer threads or another compatible connection mechanism to ensure secure and reliable coupling. The fluid channel 320 extends through the coupling portion 316, providing a controlled pathway for fluid movement between the medical device 300 and any connected external component.

[0149] FIG. 8C shows a cutaway view of the medical device 300 of FIGS. 8A-8B, with a portion of the plunger housing 328 removed along with the fluid chamber 304. The plunger 324 extends through the plunger housing 328 and terminates in the plunger head 354, which is configured to be in fluid communication with the fluid in the fluid chamber 304. The plunger head 354 can be shaped to engage with a sealing mechanism and / or fluid channel (not shown in this figure) to, for example, regulate fluid displacement within the fluid chamber 304. The plunger neck 350 can be a narrower portion of the plunger 324 between the plunger head 354 and the plunger body 334. The plunger neck 350 can be configured to couple to a collar of the stopper 372(e.g., formed by the circumferential flange 382). Thus, a difference in radius between the plunger neck 350 and plunger body 334 can better ensure a secure coupling of the stopper 372 to the plunger 324. The electronics port 399 can allow the flexible PCB 394 to fit therein. And / or the electronics port 399 can include an opening in the plunger head 354 to allow a slot for the pressure sensor 388 within the plunger head 354.

[0150] The plunger housing 328 can accommodate (e.g., house) the internal electronics described herein and / or serve as a structural element that can maintain structural integrity in response to axial pressures described herein applied thereto. The plunger housing 328 can be 3D printed and / or injection molded.

[0151] Within the plunger housing 328, the rigid PCB 395, the flexible PCB 394, the display interface 344, the PCB switch 398, the power source 393, the Hall effect sensor 391, the accelerometer 392, and / or at least a portion of the pressure sensor 388 may be located. The pressure sensor 388 can be positioned within the device to detect changes in pressure within the composite fluid chamber (e.g., the fluid chamber 304 and a cavity within the patient). The pressure sensor 388 can convert detected pressure fluctuations into electrical signals, which can be transmitted to control electronics, such as the controller 397. The flexible PCB 394 can allow for proper placement (e.g., orientation, stability) within the plunger head 354. Additionally or alternatively, the flexible PCB 394 can accommodate movement of the plunger 324 without disrupting electrical communication between the pressure sensor 388 and the controller 397.

[0152] The PCB switch 398 can be in mechanical and / or electrical communication with the actuator 346. The PCB switch 398 can be integrated into the rigid PCB 395 to allow user input and / or activation of specific device functions. The PCB switch 398 may serve as a manual control mechanism, enabling the user to initiate pressure measurements, reset the device, toggle between operational modes, and / or perform any other function described above with regard to the actuator 346.

[0153] In some implementations, a largest width (e.g., diameter) of the plunger housing 328 may be at least twice the largest width (e.g., diameter) of the plunger neck 350. This ratio can provide sufficient space to house electronic components, including the Hall effect sensor 391, accelerometer 392, and display interface 344, while ensuring that the plunger neck 350 remains naiTow enough to move smoothly within the fluid chamber 304 and / or that the plunger neck 350 is narrow enough to fit the stopper 372 thereon. Additionally, by maintaining this ratio, the displayinterface 344 can be positioned on the plunger housing 328, making it more visible to a user when the syringe is in use.

[0154] In some embodiments, a minimum diameter of the stopper aperture 378 may be between 20% and 60% of a maximum diameter of the plunger head 354. This ratio ensures that a controlled volume of fluid passes through the aperture while preventing excessive accumulation of air bubbles therein, which could otherwise introduce noise into pressure readings. Maintaining this aperture ratio relative to the plunger head 354 can allow for better alignment of the pressure sensor face 390 with the aperture, leading to more accurate and repeatable pressure measurements.

[0155] In some examples, a largest dimension of the finger flange 358 may be at least 25% of the total length of the plunger 324. This ratio provides a stable grip for the user while maintaining ergonomic handling. For example, in some embodiments the plunger 324 is approximately 30% longer than a standard 5 mL syringe plunger. By ensuring that the finger flange 358 is sufficiently large, the user can exert controlled force when depressing or retracting the plunger, reducing strain and improving precision when obtaining pressure readings. Additionally or alternatively, this size of finger flange 358 may allow the magnet 362 to be properly housed therein.

[0156] In some implementations, the plunger body 334 may have a largest width (e.g., diameter) that is at least two times the smallest width (e.g., diameter) of the plunger neck 350. This ratio allows for the plunger body 334 to house the necessary electronic components, such as the controller 397, power source 393, and flexible PCB 394, while keeping the plunger neck 350 narrow enough to maintain a proper seal with the stopper 372. Additionally, by ensuring that the plunger body 334 is sufficiently larger than the plunger neck 350, the transition between these elements can create a natural alignment stop, preventing unwanted movement or misalignment during use.

[0157] In some embodiments, the pressure sensor face 390 may have a diameter that is at least 70% of the diameter of the stopper aperture 378. This ratio ensures that the pressure sensor 388 captures a sufficient cross-section of the fluid column while sufficiently reducing exposure to peripheral flow disturbances that could introduce reading errors. By keeping the pressure sensor face 390 within this range relative to the stopper aperture 378, the system can balance sensitivity with structural protection, preventing excessive fluid ingress that could damage the sensor.

[0158] In some examples, the display aperture 342 may have a width that no greater than 70% of the largest width of a face (c.g., where the display aperture 342 is located as shown in FIG. 8 A) of the plunger housing 328. This ratio ensures that the display interface 344 remains large enough to present clear, easily readable information to the user while maintaining sufficient structural integrity of the plunger housing 328.

[0159] In some embodiments, the stopper height 380 may be between at least 30% greater than a total length of the plunger head 354. This ratio allows the stopper 372 to maintain sufficient coupling with the plunger head 354 for creating a reliable second fluid seal, while ensuring that the plunger head 354 retains sufficient structural integrity and / or to protect the pressure sensor 388. By keeping this proportional relationship, the stopper 372 can compress effectively to prevent leaks while still allowing smooth plunger movement within the barrel.

[0160] In some embodiments, the pressure sensor face 390 is positioned axially between the distal surface 376 of the stopper 372 and the distal interior surface 386 of the stopper 372. This arrangement can ensure in some embodiments that the pressure sensor 388 forms a proper seal within the stopper 372, preventing fluid leakage while maintaining direct contact with the fluid for accurate pressure readings.

[0161] In some implementations, the proximal interior surface 384 of the stopper 372 is positioned axially between the pressure sensor face 390 and the distal surface 376 of the stopper 372. This configuration may contribute to the sealing function of the pressure sensor 388 and / or provide structural support by securing the pressure sensor 388 between the plunger head 354 and the stopper 372 (depending on the embodiment). This structural integration helps stabilize the pressure sensor 388, reducing mechanical stress and ensuring its longevity and measurement accuracy.

[0162] In some examples, the distal-most surface of the pressure sensor 388 is positioned proximal to the distal-most surface of the distal surface 376 of the stopper 372. This recessed positioning protects the pressure sensor 388 from direct external forces or impacts that could otherwise compromise its function. By preventing direct exposure of the pressure sensor 388 at the extreme distal end of the device, this relationship may additionally or alternatively safeguard sensitive electronics, such as the flexible PCB 394, from mechanical damage during handling or use.

[0163] In some embodiments, a center of the flexible PCB 394 may be positioned axially between a center of the rigid PCB 395 and the pressure sensor 388. This placement can improve integrity of the assembly of the pressure sensor 388 and stopper 372 and / or ensure that the flexible PCB 394 facilitates necessary electrical connections without interfering with the pressure-sensing function. By placing the flexible PCB 394 between these components, the design balances mechanical flexibility with structural integrity.

[0164] In some implementations, when the medical device 300 is in a closed configuration (e.g., when the fluid chamber 304 is essentially empty), the magnet 362 and the Hall effect sensor 391 are positioned generally at the same axial position (e.g., radially aligned). This alignment promotes improved interaction between the Hall effect sensor 391 and the magnet 362. For example, it may allow the Hall effect sensor 391 to detect the maximum possible magnetic field strength of any normal orientation of the medical device 300. By optimizing the relative positioning of these components, the device improves proximity sensing accuracy, which directly enhances the reliability of fluid level measurement and feedback.

[0165] In some examples, a center of the display interface 344 is positioned axially between the actuator 346 and one or more of the Hall effect sensor 391 and / or pressure sensor 388. These relationships can promote proper and / or improved manipulation of the actuator 346 and / or improved visual access to the display interface 344. The arrangements may additionally or alternatively enhance ergonomic usability, such as by making adjustments or readings more intuitive for the user.

[0166] In some embodiments, the length of the display interface 344 extends generally along the fluid axis 306. This orientation increases (e.g., maximizes) the available display size within the given form factor of the medical device 300.

[0167] In some implementations, the display interface 344 and the power source 393 are positioned on opposite faces of the rigid PCB 395. This arrangement can contribute to an ergonomic balance of the medical device 300 to improve accurate manipulation by a human user. Additionally or alternatively, this arrangement can provide a balanced weight distribution for the plunger head 354, which may improve structural integrity of the rigid PCB 395. Additionally or alternatively, this relationship can help stabilize electronic components disposed on the rigid PCB 395, such as the Hall effect sensor 391 and / or the accelerometer 392, reducing unintended movement or misalignment during use and / or over time.

[0168] In some embodiments, the Hall effect sensor 391 is configured to be axially, radially, and / or circumferentially fixed relative to the track 338. This fixed positioning ensures that calibration data, such as proximity data and / or liquid calibration data, remain consistent and reliable throughout operation of the medical device 300. By securing the Hall effect sensor 391 in a stable location, the system reduces errors caused by sensor drift or misalignment, ultimately improving the accuracy of position detection and fluid level tracking.

[0169] FIG. 9 shows an example method 900 of generating a physiological reading, according to some implementations. The method 900 may be performed by any system described herein, such as the one or more controllers (e.g., sensing unit 116, the sensing unit 216, the user interface controller 244, the medical device 300, the controller 397, etc.). Additional and / or fewer steps may be implemented in the method 900 than shown.

[0170] At block 904 the system can receive physiological data while a fluid chamber of a medical device is in fluid communication within an interior of a patient (e.g., within a tissue of the patient). The physiological data may be received while the fluid chamber is in fluid communication with the interior of the patient tissue. In some embodiments, the system may access a calibration distance (e.g., corresponding to a fluid column length of a cannula or catheter) when coupled to the medical device. In some embodiments, the method 900 can include receiving (e.g., from a pressure sensor in response to manipulation of a button or other actuator) a calibrating pressure signal. The system may receive the calibrating pressure signal while the fluid chamber is not in fluid communication with the interior of the patient tissue (e.g., interior of eye).

[0171] At block 908, the system can receive calibration data. For example, the system can receive (e.g., from a proximity sensor) proximity data. The proximity sensor may include a Hall-effect sensor, optical sensor, capacitive sensor, and / or other sensor. For example, a Hall-effect sensor may detect a proximity of a magnet within the medical device and determine the proximity data therefrom. The system may generate (e.g., based on the proximity data) fluid level data indicative of a fluid level within a fluid chamber. Additionally or alternatively, the system may receive (e.g., from an accelerometer) orientation data. The orientation data may be indicative of an orientation of the fluid chamber of the medical device relative to Earth’ s gravitational field. The calibration data can include the proximity and / or orientation data.

[0172] At block 912 the system can generate a physiological reading based on the physiological data and the calibration data. For example, the system may generate a pressurereading based on the calibrating pressure signal, the pressure signal, the calibration distance, the liquid level data, and / or the orientation data.

[0173] At block 916 the system can transmit the pressure reading to a display interface. Additionally or alternatively, the system may cause the display interface to display a physiological value based on the physiological reading.

[0174] FIG. 10 depicts example system components of an example system 1000 according to example implementations of the present disclosure. The example system 1000 can include the computing system 1005 and the computing system 1050 that are communicatively coupled over one or more networks 1045.

[0175] The computing system 1005 can include one or more computing devices 1010. The computing devices 1010 of the computing system 1005 can include one or more processors 1015 and a memory 1020. The processors 1015 can be any suitable processing device (e.g., a processor core, a microprocessor, an ASIC, an FPGA, a controller, a microcontroller, etc.) and can be one processor or a plurality of processors that are operatively connected. The memory 1020 can include one or more non-transitory computer-readable storage media, such as RAM, ROM, EEPROM, EPROM, one or more memory devices, flash memory devices, etc., and combinations thereof.

[0176] The memory 1020 can store information that can be accessed by the processors 1015. For instance, the memory 1020 (e.g., one or more non-transitory computer-readable storage mediums, memory devices) can include computer- readable instructions 1025 that can be executed by the processors 1015. The instructions 1025 can be software written in any suitable programming language or can be implemented in hardware. For example, the instructions 1025 can be generated using a behavioral modeling tool. Additionally, or alternatively, the instructions 1025 can be executed in logically or virtually separate threads on processors 1015.

[0177] For example, the memory 1020 can store instructions 1025 that, when executed by the processors 1015, cause the processors 1015 to perform operations such as any of the operations and functions of any of the computing systems described herein or computing devices (e.g., the controller 124, the controller 224, the controller 397, the sensing system 100, the insertion device 102, the fluid injection sensing device 230, the medical device 300, etc.), as described herein.

[0178] The memory 1020 can store data 1030 that can be obtained, received, accessed, written, manipulated, created, or stored. The data 1030 can include, for instance, SoC information or other data / information described herein. In some implementations, the computing devices 1010 can access or store data in one or more memory devices that are remote from the computing system 1005, such as one or more memory devices of the computing system 1050.

[0179] The computing devices 1010 can also include a communication interface 1035 used to communicate with one or more other systems (e.g., computing system 1050). The communication interface 1035 can include any circuits, components, software, etc., for communicating via one or more networks (e.g., 1045). In some implementations, the communication interface 1035 can include, for example, one or more of a communications controller, receiver, transceiver, transmitter, port, conductors, software, or hardware for communicating data / information.

[0180] The computing system 1050 can include one or more computing devices 1055. The computing devices 1055 can include one or more processors 1060 and a memory 1065. The one or more processors 1060 can be any suitable processing device (e.g., a processor core, a microprocessor, an ASIC, an FPGA, a controller, a microcontroller, etc.) and can be one processor or a plurality of processors that are operatively connected. The memory 1065 can include one or more non-transitory computer-readable storage media, such as RAM, ROM, EEPROM, EPROM, one or more memory devices, flash memory devices, etc., and combinations thereof.

[0181] The memory 1065 can store information that can be accessed by the processors 1060. For instance, the memory 1065 (e.g., one or more non-transitory computer-readable storage mediums, memory devices) can store data 1075 that can be obtained, received, accessed, written, manipulated, created, or stored. The data 1075 can include, for instance, physiological data, pressure data, calibration data, correction data, display data, battery state data, battery conditions, or other data or information described herein. In some implementations, the computing system 1050 can access data from one or more memory devices that are remote from the computing system 1050.

[0182] The memory 1065 can also store computer-readable instructions 1070 that can be executed by the processors 1060. The instructions 1070 can be software written in any suitable programming language or can be implemented in hardware. Additionally, or alternatively, the instructions 1070 can be executed in logically or virtually separate threads on processors 1060. Forexample, the memory 1065 can store instructions 1070 that, when executed hy the processors 1060, cause the processors 1060 to perform any of the operations or functions described herein, including, for example, any of the operations and functions of any of the computing systems (e.g., medical devices described herein, etc.) or computing devices (e.g., user devices, medical devices, clinics, healthcare facilities, hospitals, home centers, etc.), as described herein.

[0183] The computing devices 1055 can also include a communication interface 1080 used to communicate with one or more other systems. The communication interface 1080 can include any circuits, components, software, etc., for communicating via one or more networks (e.g., 1045). In some implementations, the communication interface 1080 can include, for example, one or more of a communications controller, receiver, transceiver, transmitter, port, conductors, software, or hardware for communicating data / information.

[0184] The networks 1045 can be any type of network or combination of networks that allows for communication between devices. In some implementations, the networks 1045 can include one or more of a local area network, wide area network, the Internet, secure network, cellular network, mesh network, peer-to-peer communication link, or some combination thereof and can include any number of wired or wireless links. Communication over the networks 1045 can be accomplished, for instance, via a network interface using any type of protocol, protection scheme, encoding, format, packaging, etc.

[0185] FIG. 10 illustrates one example system 1000 that can be used to implement the present disclosure. Other computing systems can be used as well. Computing tasks discussed herein as being performed at computing devices remote from the devices described herein (e.g., the insertion device 102, the fluid injection sensing device 230, the medical device 300, etc.) can instead be performed at the device, or vice versa. Such configurations can be implemented without deviating from the scope of the present disclosure. The use of computer-based systems allows for a great variety of possible configurations, combinations, and divisions of tasks and functionality between and among components. Computer- implemented operations can be performed on a single component or across multiple components. Computer-implemented tasks or operations can be performed sequentially or in parallel. Data and instructions can be stored in a single memory device or across multiple memory devices.Example Embodiments

[0186] Below is a list of non-limiting examples of embodiments described herein. These examples are for illustrative purposes and should not be viewed to restrict or limit the disclosure herein in any way.

[0187] In a 1st Example, an insertion ophthalmic device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a syringe and cause a flow of fluid through the fluid channel generally along a fluid axis; a display interface configured to display intraocular pressure (IOP) of an interior a patient’s eye; a sensing unit coupled to the coupling unit, the coupling unit comprising: a pressure sensor configured to be in fluid communication with the fluid channel, the pressure sensor comprising a face having a normal that is transverse to the fluid axis, the pressure sensor configured to generate a pressure signal in response to an equilibrium fluid pressure of fluid within the fluid channel, the pressure sensor configured to measure an IOP of between 0 and 100 mmHg, wherein the IOP corresponds to a relative IOP compared to an exterior of the patient’s eye; a controller in electrical communication with the pressure sensor, the controller configured to: receive, from the pressure sensor, the pressure signal; convert the pressure signal to a pressure reading indicative of the IOP of the interior of the patient’s eye; transmit the pressure reading to the display interface; and cause the display interface to display the IOP based on the pressure reading; and a power source configured to be in electrical communication with the controller and with the pressure sensor, wherein the pressure sensor is disposed between the fluid channel and the display interface as well as between the fluid channel and the power source; and a cannula comprising a rigid material forming a hollow interior having an inner diameter of less than 0.3 mm, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the patient’s eye for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel, wherein the insertion ophthalmic device is configured to at least partially form a composite fluid chamber having a uniform pressure throughout the composite fluid chamber at pressure equilibrium configured to be sensed by the pressure sensor, the composite fluid chamber comprising: the fluid outlet of the syringe; the fluid channel of the coupling unit; the interior of the cannula; and the interior of the patient’s eye.

[0188] In a 2nd Example, the insertion ophthalmic device of Example 1 , further comprising a removable pull-tab configured to electrically insulate the power source from at least the controller.

[0189] In a 3rd Example, the insertion ophthalmic device of Example 2, wherein in response to a user’s manual removal of the pull-tab, power is delivered to at least the controller from the power source.

[0190] In a 4th Example, the insertion ophthalmic device of any of Examples 1-3, wherein the power source is configured to generate a current output of at least 1 mAh with a maximum current of at least 2 mA.

[0191] In a 5th Example, the insertion ophthalmic device of any of Examples 1-4, wherein a length of the sensing unit along the fluid axis is less than 20 mm, and wherein a depth of the sensing unit orthogonal to the fluid axis is less than 8 mm.

[0192] In a 6th Example, the insertion ophthalmic device of any of Examples 1-5, wherein the coupling unit is configured to releasably couple with the syringe via a Luer fitting.

[0193] In a 7th Example, an insertion medical device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a sensing unit comprising: a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel; and a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue; and cause the physiological reading to be transmitted to a display interface; and a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel.

[0194] In an 8th Example, the insertion medical device of Example 7, wherein the coupling unit is configured to cause a flow of fluid through the fluid channel generally along a fluid axis.

[0195] In a 9th Example, the insertion medical device of Example 8, wherein the physiological sensor comprises a face having a normal that is transverse to the fluid axis.

[0196] In a 10th Example, the insertion medical device of any of Examples 7-9, wherein the physiological sensor comprises a pressure sensor.

[0197] In an 11th Example, the insertion medical device of Example 10, wherein the controller is configured to convert the physiological signal to a pressure reading indicative of an interior pressure of between 0 and 100 mmHg.

[0198] In a 12th Example, the insertion medical device of Example 11, wherein the pressure reading is indicative of a relative interior pressure compared to a pressure exterior to the patient tissue.

[0199] In a 13th Example, the insertion medical device of any of Examples 7-12, wherein the fluid channel has an inner diameter greater than an inner diameter of the cannula.

[0200] In a 14th Example, the insertion medical device of Example 13, wherein the inner diameter of the fluid channel is less than 4 mm.

[0201] In a 15th Example, the insertion medical device of any of Examples 7-14, wherein the insertion medical device is configured to at least partially form a composite fluid chamber comprising: the fluid outlet of the fluid container; the fluid channel of the coupling unit; the interior of the cannula; and the interior of the patient tissue.

[0202] In a 16th Example, the insertion medical device of any of Examples 7-15, further comprising a display interface configured to indicate the physiological parameter of the interior of the patient tissue.

[0203] In a 17th Example, the insertion medical device of Example 16, wherein the display interface is electrically coupled to the controller.

[0204] In an 18th Example, the insertion medical device of any of Examples 16-17, wherein the physiological sensor is disposed between the fluid channel and the display interface.

[0205] In a 19th Example, the insertion medical device of any of Examples 16-18, wherein the display interface comprises a plurality of LED indicators.

[0206] In a 20th Example, the insertion medical device of Example 19, wherein the plurality of LED indicators comprises fewer than 10 LED indicators.

[0207] In a 21 st Example, the insertion medical device of any of Examples 16-20, wherein the display interface comprises an interactive graphical user interface configured to receive user input.

[0208] In a 22nd Example, the insertion medical device of any of Examples 7-21, further comprising a wireless transceiver configured to wirelessly transmit the physiological reading to a display interface.

[0209] In a 23rd Example, the insertion medical device of Example 22, wherein the wireless transceiver comprises a Bluetooth transceiver.

[0210] In a 24th Example, the insertion medical device of any of Examples 22-23, further comprising the display interface.

[0211] In a 25th Example, the insertion medical device of any of Examples 7-24, wherein the controller is further configured to cause the display interface to display the physiological parameter based on the physiological reading.

[0212] In a 26th Example, the insertion medical device of any of Examples 7-25, further comprising a power source configured to be in electrical communication with the controller and with the physiological sensor.

[0213] In a 27th Example, the insertion medical device of Example 26, wherein the physiological sensor is disposed between the fluid channel and the power source.

[0214] In a 28th Example, the insertion medical device of any of Examples 26-27, wherein the power source is configured to generate a current output of at least 1 mAh.

[0215] In a 29th Example, the insertion medical device of any of Examples 26-28, wherein the power source is configured to generate a maximum current of at least 2 mA.

[0216] In a 30th Example, the insertion medical device of any of Examples 26-29, further comprising a removable pull-tab configured to electrically insulate the power source from at least the controller.

[0217] In a 31st Example, the insertion medical device of Example 30, wherein in response to a user’s manual removal of the pull-tab, power is delivered to at least the controller from the power source.

[0218] In a 32nd Example, the insertion medical device of any of Examples 7-31, wherein a length of the sensing unit is less than 20 mm.

[0219] In a 33rd Example, the insertion medical device of Example 32, wherein a depth of the sensing unit orthogonal to the length is less than 8 mm.

[0220] In a 34th Example, the insertion medical device of any of Examples 7-33, wherein the coupling unit is configured to releasably couple with the fluid container via a Luer fitting.

[0221] In a 35th Example, the insertion medical device of any of Examples 7-34, wherein the coupling unit is configured to releasably couple to the fluid container via at least one of a snap fit or a screw fit.

[0222] In a 36th Example, the insertion medical device of any of Examples 7-35, wherein the hollow interior of the cannula comprises an inner diameter of less than 0.3 mm.

[0223] In a 37th Example, the insertion medical device of any of Examples 7-36, wherein the cannula comprises an outer diameter of less than 3 mm.

[0224] In a 38th Example, the insertion medical device of any of Examples 7-37, wherein the cannula comprises: an axial portion extending from the coupling unit; and an inclined portion forming an obtuse angle subtending the axial portion and the inclined portion.

[0225] In a 39th Example, the insertion medical device of Example 38, wherein the obtuse angle is between about 110° and 170°.

[0226] In a 40th Example, the insertion medical device of any of Examples 7-39, wherein the sensing unit comprises a housing that substantially forms a rectangular' prism.

[0227] In a 41st Example, the insertion medical device of Example 40, wherein the housing of the sensing unit has a length of less than 20 mm, a width of less than 20 mm, and a depth of less than 10 mm.

[0228] In a 42nd Example, the insertion medical device of any of Examples 7-41, wherein the sensing unit is connected to the coupling unit.

[0229] In a 43rd Example, the insertion medical device of Example 42, wherein the sensing unit and the coupling unit form a unitary structure.

[0230] In a 44th Example, the insertion medical device of Example 43, wherein the unitary structure comprises at least one of a glass, a polycarbonate, or a polypropylene.

[0231] In a 45th Example, the insertion medical device of any of Examples 7-44, wherein the sensing unit is releasably coupled to the coupling unit.

[0232] In a 46th Example, an insertion medical device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to rclcasably couple with a distal end of a fluid outlet of a fluid container; a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel, the physiological signal indicative of a physiological parameter of an interior of a patient tissue; a display interface configured to indicate the physiological parameter of the interior of the patient tissue; and a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel.

[0233] In a 47th Example, an insertion medical device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel, the physiological signal indicative of a physiological parameter of an interior of a patient tissue; a power source configured to be in electrical communication with the physiological sensor; and a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel.

[0234] In a 48th Example, an insertion medical device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel, the physiological signal indicative of a physiological parameter of an interior of a patient tissue; a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patienttissue; and cause the physiological reading to be transmitted to a display interface; and a power source configured to be in electrical communication with the physiological sensor and with the controller.

[0235] In a 49th Example, an insertion medical device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel, the physiological signal indicative of a physiological parameter of an interior of a patient tissue; a wireless transceiver configured to wirelessly transmit a physiological reading indicative of the physiological parameter to a display interface; and a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel.

[0236] In a 50th Example, a fluid injection sensing device comprising: a fluid chamber configured to store fluid for injection along a fluid axis into an interior of a tissue of a patient; a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a proximal end of a fluid inlet of a cannula hub; a fluid driver configured to drive fluid out of the fluid channel of the coupling unit and into the fluid inlet of the cannula hub; and a sensing unit comprising: a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel; and a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue; and cause the physiological reading to be transmitted to a display interface.

[0237] In a 51st Example, the fluid injection sensing device of Example 50, wherein the fluid chamber comprises a fluid chamber of a fluid container.

[0238] In a 52nd Example, the fluid injection sensing device of any of Examples 50- Sl, wherein the fluid chamber is configured to contain at least 5 mL of fluid.

[0239] In a 53rd Example, the fluid injection sensing device of any of Examples 50-52, wherein the fluid driver comprises a plunger of a fluid container.

[0240] In a 54th Example, the fluid injection sensing device of any of Examples SO-53, wherein the fluid driver is configured to be manually manipulated to drive the fluid out of a fluid outlet of the fluid chamber.

[0241] In a 55th Example, the fluid injection sensing device of any of Examples SO-54, further comprising the cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel of the coupling unit.

[0242] In a 56th Example, the fluid injection sensing device of Example 55, wherein the hollow interior of the cannula comprises an inner diameter of less than 0.3 mm.

[0243] In a 57th Example, the fluid injection sensing device of any of Examples 55-56, wherein the cannula comprises an outer diameter of less than 3 mm.

[0244] In a 58th Example, the fluid injection sensing device of any of Examples 55-57, wherein the cannula comprises: an axial portion extending substantially parallel with the fluid axis; and an inclined portion forming an obtuse angle subtending the axial portion and the inclined portion.

[0245] In a 59th Example, the fluid injection sensing device of Example 58, wherein the obtuse angle is between about 110° and 170°.

[0246] In a 60th Example, the fluid injection sensing device of any of Examples 55-59, wherein the fluid injection sensing device is configured to at least partially form a composite fluid chamber comprising: the fluid chamber; the fluid channel of the coupling unit; the interior of the cannula; and the interior of the patient tissue.

[0247] In a 61stth Example, the fluid injection sensing device of any of Examples 50-60, wherein the coupling unit is configured to cause a flow of fluid through the fluid channel generally along a fluid axis.

[0248] In a 62ndth Example, the fluid injection sensing device of Example 51-61, wherein the physiological sensor comprises a face having a normal that is transverse to the fluid axis.

[0249] In a 63rdth Example, the fluid injection sensing device of any of Examples 50- 62, wherein the physiological sensor comprises a pressure sensor.

[0250] In a 64th Example, the fluid injection sensing device of Example 63, wherein the controller is configured to convert a pressure signal to a pressure reading indicative of an interior pressure of between 0 and 100 mmHg.

[0251] In a 65th Example, the fluid injection sensing device of Example 64, wherein the pressure reading is indicative of a relative interior pressure compared to a pressure exterior to the patient tissue.

[0252] In a 66th Example, the fluid injection sensing device of any of Examples 50-65, wherein the fluid channel has an inner diameter smaller than an inner diameter of the fluid chamber.

[0253] In a 67th Example, the fluid injection sensing device of any of Examples SO-66, wherein an inner diameter of the fluid channel is less than 4 mm.

[0254] In a 68th Example, the fluid injection sensing device of any of Examples SO-67, further comprising a display interface configured to indicate the physiological parameter of the interior of the patient tissue.

[0255] In a 69th Example, the fluid injection sensing device of Example 68, wherein the display interface is electrically coupled to the controller.

[0256] In a 70th Example, the fluid injection sensing device of any of Examples 68- 69, wherein the physiological sensor is disposed between the fluid channel and the display interface.

[0257] In a 71st Example, the fluid injection sensing device of any of Examples 68-70, wherein the display interface comprises a plurality of LED indicators.

[0258] In a 72nd Example, the fluid injection sensing device of Example 71, wherein the plurality of LED indicators comprises fewer than 10 LED indicators.

[0259] In a 73rd Example, the fluid injection sensing device of any of Examples 68-72, wherein the display interface comprises an interactive graphical user interface configured to receive user input.

[0260] In a 74th Example, the fluid injection sensing device of any of Examples SO-73, further comprising a wireless transceiver configured to wirelessly transmit the physiological reading to a display interface.

[0261] In a 75th Example, the fluid injection sensing device of Example 74, wherein the wireless transceiver comprises a Bluetooth transceiver.

[0262] In a 76th Example, the fluid injection sensing device of any of Examples SO-75, further comprising the display interface.

[0263] In a 77th Example, the fluid injection sensing device of any of Examples SO-76, wherein the controller is further configured to cause the display interface to display the physiological parameter based on the physiological reading.

[0264] In a 78th Example, the fluid injection sensing device of any of Examples SO-77, further comprising a power source configured to be in electrical communication with the controller and with the physiological sensor.

[0265] In a 79th Example, the fluid injection sensing device of Example 78, wherein the physiological sensor is disposed between the fluid channel and the power source.

[0266] In an 80th Example, the fluid injection sensing device of any of Examples 78-79, wherein the power source is configured to generate a current output of at least 1 mAh.

[0267] In an 81st Example, the fluid injection sensing device of any of Examples 78-80, wherein the power source is configured to generate a maximum current of at least 2 mA.

[0268] In an 82nd Example, the fluid injection sensing device of any of Examples 78-81, wherein the power source comprises a battery.

[0269] In an 83rd Example, the fluid injection sensing device of any of Examples 78-82, further comprising a removable pull-tab configured to electrically insulate the power source from at least the controller.

[0270] In an 84th Example, the fluid injection sensing device of Example 83, wherein in response to a user’s manual removal of the pull-tab, power is delivered to at least the controller from the power source.

[0271] In an 85th Example, the fluid injection sensing device of any of Examples SO-84, wherein a length of the sensing unit along the fluid axis is less than 20 mm.

[0272] In an 86th Example, the fluid injection sensing device of any of Examples SO-85, wherein a depth of the sensing unit orthogonal to the fluid axis is less than 8 mm.

[0273] In an 87th Example, the fluid injection sensing device of any of Examples SO-86, wherein the coupling unit is configured to releasably couple with the cannula hub via a Luer fitting.

[0274] In an 88th Example, the fluid injection sensing device of any of Examples 50-87, wherein the coupling unit is configured to rclcasably coupled to the cannula hub via at least one of a snap fit or a screw fit.

[0275] In a 89th Example, the fluid injection sensing device of any of Examples SO-88, wherein the sensing unit comprises a housing that substantially forms a rectangular prism.

[0276] In a 90th Example, the fluid injection sensing device of Example 89, wherein the housing of the sensing unit has a length of less than 20 mm, a width of less than 20 mm, and a depth of less than 10 mm.

[0277] In a 91st Example, the fluid injection sensing device of any of Examples 50-90, wherein the sensing unit is connected to the coupling unit.

[0278] In a 92nd Example, the fluid injection sensing device of any of Examples 89- 91, wherein the sensing unit and the coupling unit form a unitary structure.

[0279] In a 93rd Example, the fluid injection sensing device of Example 92, wherein the unitary structure comprises at least one of a glass, a polycarbonate, or a polypropylene.

[0280] In a 94th Example, the fluid injection sensing device of any of Examples SO- 93, wherein the sensing unit is releasably coupled to the coupling unit.

[0281] In a 95th Example, an intermediate sensing device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with both a distal end of a fluid outlet of a fluid container and a proximal end of a fluid inlet of a cannula hub; and a sensing unit comprising: a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel; and a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue; and cause the physiological reading to be transmitted to a display interface.

[0282] In a 96th Example, the intermediate sensing device of Example 95, wherein the fluid channel is configured to contain no more than 1 mL of fluid.

[0283] In a 97th Example, the intermediate sensing device of any of Examples 95-96, further comprising the cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be insertedinto the interior of the patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel of the coupling unit.

[0284] In a 98th Example, the intermediate sensing device of Example 97, wherein the hollow interior of the cannula comprises an inner diameter of less than 0.3 mm.

[0285] In a 99th Example, the intermediate sensing device of any of Examples 97-98, wherein the cannula comprises an outer diameter of less than 3 mm.

[0286] In a 100th Example, the intermediate sensing device of any of Examples 97-99, wherein the cannula comprises: an axial portion extending from the coupling unit; and an inclined portion forming an obtuse angle subtending the axial portion and the inclined portion.

[0287] In a 101st Example, the intermediate sensing device of Example 100, wherein the obtuse angle is between about 110° and 170°.

[0288] In a 102nd Example, the intermediate sensing device of any of Examples 95-101, wherein the intermediate sensing device is configured to at least partially form a composite fluid chamber comprising: the fluid outlet of the fluid container; the fluid inlet of the cannula hub; the fluid channel of the coupling unit; and the interior of the patient tissue.

[0289] In a 103rd Example, the intermediate sensing device of any of Examples 95-102, wherein the coupling unit is configured to cause a flow of fluid through the fluid channel generally along a fluid axis.

[0290] In a 104th Example, the intermediate sensing device of Example 103, wherein the physiological sensor comprises a face having a normal that is transverse to the fluid axis.

[0291] In a 105th Example, the intermediate sensing device of any of Examples 95- 104, wherein the physiological sensor comprises a pressure sensor.

[0292] In a 106th Example, the intermediate sensing device of any of Examples 105, wherein the controller is configured to convert a pressure signal to a pressure reading indicative of an interior pressure of between 0 and 100 mmHg.

[0293] In a 107th Example, the intermediate sensing device of Example 106, wherein the pressure reading is indicative of a relative interior pressure compared to a pressure exterior to the patient tissue.

[0294] In a 108th Example, the intermediate sensing device of any of Examples 95- 107, wherein the fluid channel has an inner diameter of less than 4 mm.

[0295] In a 109th Example, the intermediate sensing device of any of Examples 95- 108, further comprising a display interface configured to indicate the physiological parameter of the interior of the patient tissue.

[0296] In a 110th Example, the intermediate sensing device of Example 109, wherein the display interface is electrically coupled to the controller.

[0297] In a 111th Example, the intermediate sensing device of any of Examples 109-110, wherein the physiological sensor is disposed between the fluid channel and the display interface.

[0298] In a 112th Example, the intermediate sensing device of any of Examples 109-111, wherein the display interface comprises a plurality of LED indicators.

[0299] In a 113th Example, the intermediate sensing device of Example 112, wherein the plurality of LED indicators comprises fewer than 10 LED indicators.

[0300] In a 114th Example, the intermediate sensing device of any of Examples 109-113, wherein the display interface comprises an interactive graphical user interface configured to receive user input.

[0301] In a 115th Example, the intermediate sensing device of any of Examples 95-114, further comprising a wireless transceiver configured to wirelessly transmit the physiological reading to a display interface.

[0302] In a 116th Example, the intermediate sensing device of Example 115, wherein the wireless transceiver comprises a Bluetooth transceiver.

[0303] In a 117th Example, the intermediate sensing device of any of Examples 109-116, further comprising the display interface.

[0304] In a 118th Example, the intermediate sensing device of any of Examples 109-117, wherein the controller is further configured to cause the display interface to display the physiological parameter based on the physiological reading.

[0305] In a 119th Example, the intermediate sensing device of any of Examples 95-118, further comprising a power source configured to be in electrical communication with the controller and with the physiological sensor.

[0306] In a 120th Example, the intermediate sensing device of Example 119, wherein the physiological sensor is disposed between the fluid channel and the power source.

[0307] In a 121 st Example, the intermediate sensing device of any of Examples 119-120, wherein the power source is configured to generate a current output of at least 1 mAh.

[0308] In a 122nd Example, the intermediate sensing device of any of Examples 119-121, wherein the power source is configured to generate a maximum current of at least 2 mA.

[0309] In a 123rd Example, the intermediate sensing device of any of Examples 119-122, wherein the power source comprises a battery.

[0310] In a 124th Example, the intermediate sensing device of any of Examples 119-123, further comprising a removable pull-tab configured to electrically insulate the power source from at least the controller.

[0311] In a 125th Example, the intermediate sensing device of Example 124, wherein in response to a user’s manual removal of the pull-tab, power is delivered to at least the controller from the power source.

[0312] In a 126th Example, the intermediate sensing device of any of Examples 95- 125, wherein a length of the sensing unit is less than 20 mm.

[0313] In a 127th Example, the intermediate sensing device of Example 126, wherein a depth of the sensing unit orthogonal to the length is less than 8 mm.

[0314] In a 128th Example, the intermediate sensing device of any of Examples 95-127, wherein the coupling unit is configured to releasably couple with the cannula hub via a Luer fitting.

[0315] In a 129th Example, the intermediate sensing device of any of Examples 95-128, wherein the coupling unit is configured to releasably coupled to the cannula hub via at least one of a snap fit or a screw fit.

[0316] In a 130th Example, the intermediate sensing device of any of Examples 95-129, wherein the sensing unit comprises a housing that substantially forms a rectangular prism.

[0317] In a 131st Example, the intermediate sensing device of Example 130, wherein the housing of the sensing unit has a length of less than 20 mm, a width of less than 20 mm, and a depth of less than 10 mm.

[0318] In a 132nd Example, the intermediate sensing device of any of Examples 95- 131, wherein the sensing unit is connected to the coupling unit.

[0319] In a 133rd Example, the intermediate sensing device of Example 132, wherein the sensing unit and the coupling unit form a unitary structure.

[0320] In a 134th Example, the intermediate sensing device of Example 133, wherein the unitary structure comprises at least one of a glass, a polycarbonate, or a polypropylene.

[0321] In a 135th Example, the intermediate sensing device of any of Examples 95134, wherein the sensing unit is releasably coupled to the coupling unit.

[0322] In a 136th Example, an insertion sensing device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, the cannula configured to be inserted into the interior of patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel; a physiological sensor disposed at a distal end of the cannula, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the interior of the patient tissue; and a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue; and cause the physiological reading to be transmitted to a display interface.

[0323] In a 137th Example, the insertion sensing device of Example 136, wherein the physiological sensor is configured to be in fluid communication with the fluid channel of the coupling unit.

[0324] In a 138th Example, the insertion sensing device of any of Examples 136-137, wherein the physiological sensor comprises a pressure sensor, and wherein the physiological parameter comprises a fluid pressure.

[0325] In a 139th Example, the insertion sensing device of Example 138, wherein the controller is configured to convert the physiological signal to a pressure reading indicative of an interior pressure of between 0 and 100 mmHg.

[0326] In a 140th Example, the insertion sensing device of Example 139, wherein the pressure reading is indicative of a relative interior pressure compared to a pressure exterior to the patient tissue.

[0327] In a 141st Example, the insertion sensing device of any of Examples 139-140, wherein the pressure sensor is configured to sense fluid pressures of between 5 and 40 mmHg.

[0328] In a 142nd Example, the insertion sensing device of any of Examples 139-141 , wherein the pressure sensor comprises at least one of a MEMS sensor, an optical sensor, an optical fiber, a diaphragm, a piezoelectric material, or an ultrasound transducer.

[0329] In a 143rd Example, the insertion sensing device of any of Examples 138-142, wherein the fluid channel has an inner diameter greater than an inner diameter of the cannula.

[0330] In a 144th Example, the insertion sensing device of Example 143, wherein the inner diameter of the cannula is less than 3 mm.

[0331] In a 145th Example, the insertion sensing device of any of Examples 143-144, wherein an outer diameter of the cannula is less than 4 mm.

[0332] In a 146th Example, the insertion sensing device of Example 145, further comprising a display interface configured to indicate the physiological parameter of the interior of the patient tissue.

[0333] In a 147th Example, the insertion sensing device of Example 146, wherein the display interface is electrically coupled to the controller.

[0334] In a 148th Example, the insertion sensing device of any of Examples 146-147, wherein the display interface comprises a plurality of LED indicators.

[0335] In a 149th Example, the insertion sensing device of any of Examples 146-148, wherein the display interface comprises an interactive graphical user interface configured to receive user input.

[0336] In a 150th Example, the insertion sensing device of any of Examples 136-149, further comprising a wireless transceiver configured to wirelessly transmit the physiological reading to a display interface.

[0337] In a 151st Example, the insertion sensing device of Example 150, wherein the wireless transceiver comprises a Bluetooth transceiver.

[0338] In a 152nd Example, the insertion sensing device of Example 151, further comprising the display interface.

[0339] In a 153rd Example, the insertion sensing device of any of Examples 136-, further comprising a power source configured to generate a current output of at least 1 mAh and electrically coupled to the controller and to the physiological sensor.

[0340] In a 154th Example, the insertion sensing device of Example 153, wherein the power source is configured to generate a maximum current of at least 2 mA.

[0341] In a 155th Example, the insertion sensing device of Example 154, further comprising a removable pull-tab configured to electrically insulate the power source from at least the controller.

[0342] In a 156th Example, the insertion sensing device of Example 155, wherein in response to a user’s manual removal of the pull-tab, power is delivered to at least the controller from the power source.

[0343] In a 157th Example, the insertion sensing device of any of Examples 136-156, wherein the coupling unit is configured to releasably couple with the fluid container via a Luer fitting.

[0344] In a 158th Example, the insertion sensing device of any of Examples 136-157, wherein the physiological sensor has an outer diameter no greater than an outer diameter of the cannula.

[0345] In a 159th Example, the insertion sensing device of any of Examples 136-158, wherein the physiological sensor is configured to be inserted into the interior of the patient tissue.

[0346] In a 160th Example, the insertion sensing device of any of Examples 136-159, wherein the cannula and physiological sensor are configured to cause fluid to be expelled from the cannula transverse to an extended portion of the cannula.

[0347] In a 161st Example, the insertion sensing device of any of Examples 136-160, wherein the cannula and physiological sensor are configured to cause fluid to be expelled from a sidewall of the cannula.

[0348] In a 162nd Example, the insertion sensing device of any of Examples 136-161, wherein a width of the physiological sensor is less than 0.35 mm.

[0349] In a 163rd Example, the insertion sensing device of any of Examples 136-162, wherein electrical leads connecting the physiological sensor and the controller extend along at least a portion of the cannula.

[0350] In a 164th Example, an insertion device comprising: a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a distal end of a fluid outlet of a fluid container; a cannula comprising a rigid material forming a hollow interior, the cannula connected to and extending axially from the coupling unit, a distal end of the cannula configured to be inserted into the interior of patient tissue for delivering fluid therein, wherein the cannula is in fluid communication with the fluid channel of the coupling unit; and arelief valve in fluid communication with both the fluid outlet of the fluid container and an interior of the cannula, the relief valve configured to open in response to a fluid pressure greater than a threshold fluid pressure.

[0351] In a 165th Example, the insertion device of Example 164, wherein the relief valve is further configured to cause fluid that would otherwise increase the fluid pressure beyond the threshold fluid pressure to flow away from the distal end of the cannula.

[0352] In a 166th Example, the insertion device of any of Examples 164-165, further comprising a relief fluid chamber fluidly coupled to the relief valve.

[0353] In a 167th Example, the insertion device of Example 166, wherein, in response to the fluid pressure being greater than the threshold fluid pressure, the relief valve is configured to guide additional fluid into the relief fluid chamber via a relief outlet.

[0354] In a 168th Example, the insertion device of any of Examples 164- 167, wherein the threshold fluid pressure is less than 50 mmHg.

[0355] In a 169th Example, the insertion device of any of Examples 164-168, further comprising a pressure plate configured, in response to the threshold fluid being greater than the threshold fluid pressure, to contact the relief valve to reduce fluid flow through the cannula.

[0356] In a 170th Example, the insertion device of Example 169, further comprising a resilient member configured to cause the relief valve to contact the pressure plate in response to threshold fluid being greater than the threshold fluid pressure.

[0357] In a 171st Example, the insertion device of Example 170, wherein the resilient member is connected to the relief valve.

[0358] In a 172nd Example, the insertion device of any of Examples 170-171, wherein the threshold fluid pressure is manually adjustable.

[0359] In a 173rd Example, a disposable ophthalmic device comprising: a housing of the disposable ophthalmic device, the housing configured to be releasably coupled to a fluid container, the housing comprising: a fluid inlet configured to be in fluid communication with a fluid outlet of the fluid container; a pressure sensor configured to output a pressure reading; a data interface in electrical communication with the pressure sensor, the data interface configured to transmit the pressure reading to a display interface; and an electrical interface couplable to a power supply, the electrical interface being in electrical communication with the pressure sensor and the data interface; and a cannula coupled to the housing, the cannula configured to be inserted into aportion of a patient’s eye, the cannula comprising: a first cannula configured to be in fluid communication with the fluid inlet of the housing; and a second cannula comprising a resilient membrane configured to be deformed based on a pressure incident thereon, the second cannula being in fluid communication with the pressure sensor of the housing.

[0360] In a 174th Example, the disposable ophthalmic device of Example 173, further comprising the display interface and a data wire connecting the data interface and the display interface.

[0361] In a 175th Example, the disposable ophthalmic device of any of Examples 173- 174, wherein the cannula comprises: an axial portion extending substantially parallel with an axis of the fluid container; and an inclined portion forming an obtuse angle subtending the axial portion and the inclined portion.

[0362] In a 176th Example, the disposable ophthalmic device of Example 175, wherein the obtuse angle is between about 110° and 170°.

[0363] In a 177th Example, the disposable ophthalmic device of any of Examples 173-176, wherein the housing is releasably coupled to the fluid container via at least one of a snap fit or a screw fit.

[0364] In a 178th Example, the disposable ophthalmic device of any of Examples 173-177, wherein the housing further comprises a second fluid inlet configured to be in fluid communication with a second fluid outlet of the fluid container, and wherein the cannula further comprises a third cannula configured to be in fluid communication with the second fluid inlet of the housing.

[0365] In a 179th Example, the disposable ophthalmic device of any of Examples 173-178, wherein a diameter of the first cannula is greater than a diameter of the second cannula.

[0366] In a 180th Example, the disposable ophthalmic device of any of Examples 173-179, wherein a diameter of the first cannula is less than 3 mm.

[0367] In a 181st Example, the disposable ophthalmic device of any of Examples 173-180, wherein the housing is substantially cylindrical, and wherein a diameter of the housing is no greater than about four times a diameter of the cannula.

[0368] In a 182nd Example, the disposable ophthalmic device of any of Examples 173-181, wherein the cannula comprises at least one of a glass, a polycarbonate, or a polypropylene.

[0369] In a 183rd Example, a fluid injection sensing device comprising: a fluid chamber configured to store fluid for injection along a fluid axis into an interior of a tissue of a patient; a coupling unit comprising a fluid channel configured to be in fluid communication with and to releasably couple with a proximal end of a fluid inlet of a cannula hub; a fluid driver configured to drive fluid out of the fluid channel of the coupling unit and into the fluid inlet of the cannula hub; a sensing unit comprising a physiological sensor configured to be in fluid communication with the fluid channel, the physiological sensor configured to generate a physiological signal in response to a physiological parameter of fluid within the fluid channel; and an interface control unit comprising a user interface, the interface control unit being removably couplable to the sensing unit at a unit interface, the user interface configured to display an indication of the physiological parameter of the fluid within the fluid channel.

[0370] In a 184th Example, the fluid injection sensing device of Example 183, further comprising: a controller in electrical communication with the physiological sensor, the controller configured to: receive, from the physiological sensor, the physiological signal; convert the physiological signal to a physiological reading indicative of a physiological parameter within an interior of a patient tissue; and cause the physiological reading to be transmitted to the user interface.

[0371] In a 185th Example, the fluid injection sensing device of any of Examples 184, wherein the controller is disposed within a housing of the sensing unit.

[0372] In a 186th Example, the fluid injection sensing device of any of Examples 184-185, further comprising a second controller configured to receive a physiological reading from the controller and to cause the user interface to display the indication of the physiological parameter based on the physiological reading.

[0373] In a 187th Example, the fluid injection sensing device of any of Examples 183-186, further comprising a power source configured to be in electrical communication with the physiological sensor and with the controller.

[0374] In a 188th Example, the fluid injection sensing device of Example 187, wherein the power source is disposed within the interface control unit.

[0375] In a 189th Example, the fluid injection sensing device of any of Examples 187- 188, wherein the power source is configured to be in electrical communication with the physiological sensor and the controller via the unit interface.

[0376] In a 190th Example, the fluid injection sensing device of any of Examples 187-189, wherein the unit interface comprises a magnetic interface configured to bias the unit interface into an electrically connected configuration.

[0377] In a 191st Example, the fluid injection sensing device of any of Examples 183-190, further comprising a coupling interface configured to guide the interface control unit into a proper orientation during coupling with the sensing unit.

[0378] In a 192nd Example, the fluid injection sensing device of Example 191-191, wherein the coupling interface comprises a guide rail.

[0379] In a 193rd Example, the fluid injection sensing device of any of Examples 183-192, further comprising a charging interface disposed within a housing of the interface control unit configured to allow reusability of the interface control unit.

[0380] In a 194th Example, the fluid injection sensing device of any of Examples 183-193, wherein at least the fluid chamber and the sensing unit are configured to be disposable.

[0381] In a 195th Example, the fluid injection sensing device of any of Examples 183-194, further comprising one or more interface control elements configured to allow a user to provide input into the user interface.

[0382] In Example 196, a medical device comprising: a fluid chamber configured to contain fluid; a plunger comprising a stopper and a plunger housing configured to be moveable within the fluid chamber; a pressure sensor disposed at least partially within the plunger such that the pressure sensor is configured to be in fluid communication with the fluid chamber; a calibration sensor configured to generate calibration data; a controller in electrical communication with the pressure sensor, the controller configured to: receive, from the pressure sensor, pressure data while the fluid chamber is in fluid communication within an interior of a patient; receive, from the calibration sensor, the calibration data; generate a pressure reading based on the pressure data and the calibration data, wherein the pressure reading is indicative of a pressure of the interior of the patient; transmit the pressure reading to a display interface; and cause the display interface to display the pressure based on the pressure reading.

[0383] In Example 197, the medical device of Example 196, wherein the fluid chamber comprises: a sidewall; a chamber flange; and a coupling portion at a distal end of the fluid chamber and comprises a fluid channel configured to be in fluid communication with and to releasably couple to a proximal end of a fluid inlet of a fluid coupling, the coupling portion configured tocause, in response to axial movement of the plunger within the fluid chamber, a flow of a fluid through the fluid channel generally along a fluid axis.

[0384] In Example 198, the medical device of any of Examples 196-197, wherein the plunger housing comprises: a body comprising: a track disposed axially along an exterior of the body; a display aperture configured to allow viewing of a display of the pressure of the interior the patient; and a button configured to interact with electronics of the medical device.

[0385] In Example 199, the medical device of Example 198, wherein the plunger housing further comprises: a head at a distal end of the plunger; and a neck comprising a circumferential recess between the body and the head of the plunger housing, the circumferential recess configured to couple with a circumferential flange of the stopper.

[0386] In Example 200, the medical device of any of Examples 196-199, further comprising a finger flange comprising a flange housing configured to be fixedly coupled about a chamber flange of the fluid chamber, the flange housing configured to fixedly house a magnet relative to the finger flange, wherein the flange housing comprises a protrusion configured to couple to the track of the plunger housing and to prevent rotation of the plunger relative to the magnet about a fluid axis.

[0387] In Example 201, the medical device of any of Examples 196-200, wherein the stopper has a durometer greater than 50 Shore A and is configured to provide a first fluid seal with a sidewall of the fluid chamber.

[0388] In Example 202, the medical device of any of Examples 200-201, wherein the stopper comprises: a distal surface configured to be in contact with the fluid and to drive the fluid into or out of the fluid chamber, the distal surface forming an aperture within a center of the distal surface of the stopper, the aperture being generally disposed about the fluid axis; and a circumferential flange disposed at a proximal end of the stopper, the circumferential flange forming a collar configured to couple about a neck of the plunger housing.

[0389] In Example 203, the medical device of Example 202, wherein the aperture has an axial height of less than 5 mm.

[0390] In Example 204, the medical device of any of Examples 196-203, wherein a fit of the stopper is configured to result in simultaneous contact between a head of the plunger housing and each of a proximal interior surface and a distal interior surface of the stopper, forming a secondfluid seal configured to prevent fluid ingress into an interior of a body of the plunger housing for pressures below a threshold pressure at a surface of the stopper.

[0391] In Example 205, the medical device of Example 204, wherein the second fluid seal is formed for at least 350° about the fluid axis.

[0392] In Example 206, the medical device of any of Examples 204-205, wherein the threshold pressure is 10 pounds per square inch (psi).

[0393] In Example 207, the medical device of any of Examples 196-206, wherein the pressure sensor is further configured to: be in contact with a proximal interior surface of the stopper; include a face having a normal parallel to a fluid axis, the face configured to be recessed within an aperture of the stopper such that a column of fluid forms within the aperture of the stopper at the face of the pressure sensor; and generate a plurality of pressure signals in response to a fluid pressure within the fluid chamber.

[0394] In Example 208, the medical device of any of Examples 196-207, wherein the pressure sensor is further configured to measure a pressure between 0 and 100 mmHg to a precision of at least a tenth of a mmHg, wherein the pressure corresponds to a relative pressure compared to atmosphere.

[0395] In Example 209, the medical device of any of Examples 196-208, wherein the pressure sensor is further configured to maintain functionality in response to pressures below 40 psi applied thereto.

[0396] In Example 210, the medical device of any of Examples 196-209, wherein the calibration sensor comprises a proximity sensor comprising a Hall effect sensor disposed within the plunger housing, the Hall effect sensor configured to generate proximity data based on a distance between the Hall effect sensor and a magnet.

[0397] In Example 211, the medical device of Example 210, wherein the magnet is configured to be housed in a flange housing.

[0398] In Example 212, the medical device of any of Examples 196-211, wherein the calibration sensor comprises an accelerometer configured to generate orientation data indicative of an orientation of the fluid chamber relative to Earth’s gravitational field.

[0399] In Example 213, the medical device of Example 212, wherein the controller is further configured to: receive, from the accelerometer, the orientation data; and generate, based onthe orientation data, orientation data indicative of the orientation of the fluid chamber relative to Earth’s gravitational field.

[0400] In Example 214, the medical device of Example 213, wherein generating the pressure reading is further based on the orientation data.

[0401] In Example 215, the medical device of any of Examples 196-214, wherein the controller is further configured to: access a calibration distance corresponding to a fluid column length of a cannula when coupled to the medical device.

[0402] In Example 216, the medical device of Example 215, wherein generating the pressure reading is further based on the calibration distance.

[0403] In Example 217, the medical device of any of Examples 196-216, wherein the controller is further configured to: receive, from the pressure sensor in response to manipulation of a button, a calibrating pressure signal.

[0404] In Example 218, the medical device of Example 217, wherein generating the pressure reading is further based on the calibrating pressure signal.

[0405] In Example 219, the medical device of any of Examples 196-218, wherein the controller is further configured to: generate, based on the calibration data, fluid level data indicative of a fluid level within the fluid chamber.

[0406] In Example 220, the medical device of Example 219, wherein generating the pressure reading is further based on the fluid level data.

[0407] In Example 221, the medical device of any of Examples 196-220, wherein the pressure reading is indicative of an intraocular pressure (IOP) of an interior of a patient’s eye.

[0408] In Example 222, the medical device of any of Examples 196-221, further comprising processing electronics comprising: a sensor module disposed at least partially within the stopper; and a main portion disposed within a body of the plunger housing.

[0409] In Example 223, the medical device of any of Examples 196-222, further comprising a power source housed within the plunger housing and configured to be in electrical communication with the controller and with the pressure sensor.

[0410] In Example 224, the medical device of Example 223, wherein the power source comprises a soft latching power circuit architecture.

[0411] In Example 225, the medical device of any of Examples 196-224, wherein the pressure sensor is disposed between a distal end of the fluid chamber and the display interface as well as between the distal end of the fluid chamber and the power source.

[0412] In Example 226, the medical device of Example 225, wherein the medical device is configured to at least partially form a composite fluid chamber having a measurable pressure throughout the composite fluid chamber at hydrostatic equilibrium, the composite fluid chamber comprising: the fluid chamber of the medical device; a fluid inlet of a fluid channel of a patient interface coupled to the medical device; and an interior of the patient.

[0413] In Example 227, an ophthalmic device comprising: a fluid chamber disposed along a fluid axis and configured to contain liquid, the fluid chamber comprising: a sidewall; a chamber flange; and a coupling portion at a distal end of the fluid chamber and comprising a fluid channel configured to be in fluid communication with and to releasably couple to a proximal end of a fluid inlet of a cannula; a plunger comprising a plunger housing configured to be disposed in and moveable within the fluid chamber, wherein the coupling portion of the fluid chamber is configured to cause, in response to axial movement of the plunger within the fluid chamber, a flow of the liquid through the fluid channel generally along the fluid axis, wherein the plunger housing comprises: a body comprising: a track disposed axially along an exterior thereof; a display aperture configured to allow viewing of a display of the intraocular pressure (IOP) of an interior a patient’s eye; and a button configured to interact with electronics of the ophthalmic device; a head at a distal end of the plunger; and a neck comprising a circumferential recess between the body and the head of the plunger housing; a finger flange comprising a flange housing configured to be fixedly coupled about the chamber flange of the fluid chamber, the flange housing configured to house a magnet configured to be fixed relative to the finger flange, wherein the flange housing comprises a protrusion configured to couple to the track of the plunger housing and to prevent rotation of the plunger about the fluid axis relative to the magnet; a stopper coupled to the head of the plunger housing and comprising a resilient material having a durometer greater than 50 Shore A, the stopper configured to provide a first liquid seal with the sidewall of the fluid chamber, wherein the stopper comprises: a distal surface configured to be in contact with the liquid and to drive the liquid into or out of the fluid chamber, the distal surface forming an aperture within a center of the distal surface of the stopper and generally disposed about the fluid axis, the aperture having an axial height of less than 5 mm; and a circumferential flange disposed at a proximal end of thestopper, the circumferential flange forming a collar configured to couple about the neck of the plunger housing, wherein a fit of the stopper is configured to result in simultaneous contact between the head of the plunger housing and each of a proximal interior surface and a distal interior surface of the stopper, forming a second liquid seal for at least 350° about the fluid axis, the second liquid seal configured to prevent fluid ingress into an interior of the body of the plunger housing for pressures below 40 pounds per square inch (psi) at the second liquid seal; a pressure sensor configured to be housed at least partially within the stopper such that the pressure sensor is configured to: be in contact with the proximal interior surface of the stopper; be in fluid communication with the fluid channel; include a face having a normal parallel to the fluid axis, the face configured to be recessed within the aperture of the stopper such that a column of liquid forms within the aperture of the stopper at the face of the pressure sensor; generate a plurality of pressure signals in response to a liquid pressure within the fluid channel; measure an IOP between 0 and 100 mmHg to a precision of at least a tenth of a mmHg, wherein the IOP corresponds to a relative IOP compared to atmosphere; and maintain operation in response to pressures below 40 psi; a proximity sensor comprising a Hall effect sensor disposed within the plunger housing, the Hall effect sensor configured to generate proximity data based on a distance between the Hall effect sensor and the magnet housed in the flange housing; an accelerometer configured to generate an orientation signal indicative of an orientation of the fluid chamber relative to Earth’s gravitational field; a controller in electrical communication with the pressure sensor and disposed within the plunger, the controller configured to: access a calibration distance corresponding to a fluid column length of the cannula when coupled to the ophthalmic device; receive, from the pressure sensor in response to manipulation of a button, a calibration signal; generate, based on the calibration signal, the fluid pressure reading; access, from the accelerometer, the orientation signal indicative of the orientation of the fluid chamber relative to Earth’s gravitational field; and based on the orientation signal, generate orientation data indicative of the orientation of the fluid chamber relative to Earth’s gravitational field; and generate the IOP based on the orientation data.Other Considerations

[0414] It is to be understood that not necessarily all objects or advantages may be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that certain embodiments may be configured to operate in a mannerthat achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein.

[0415] All of the processes described herein may be embodied in, and fully automated via, software code modules executed by a computing system that includes one or more computers or processors. The code modules may be stored in any type of non-transitory computer-readable medium or other computer storage device. Some or all the methods may be embodied in specialized computer hardware. Further, the computing system may include, be implemented as part of, or communicate with an automated blood glucose system, an ambulatory medicament system, or an ambulatory medical device.

[0416] Many other variations than those described herein will be apparent from this disclosure. For example, depending on the embodiment, certain acts, events, or functions of any of the algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (for example, not all described acts or events are necessary for the practice of the algorithms). Moreover, in certain embodiments, acts or events can be performed concurrently, for example, through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, different tasks or processes can be performed by different machines and / or computing systems that can function together.

[0417] The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a processing unit or processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor can also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Althoughdescribed herein primarily with respect to digital technology, a processor may also include primarily analog components. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.

[0418] Conditional language such as, among others, “can,” “could,” “might” or “may,” unless specifically stated otherwise, are otherwise understood within the context as used in general to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment.

[0419] Disjunctive language such as the phrase “at least one of X, Y, or Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (for example, X, Y, and / or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.

[0420] Any process descriptions, elements or blocks in the flow diagrams described herein and / or depicted in the attached figures should be understood as potentially representing modules, segments, or portions of code which include one or more executable instructions for implementing specific logical functions or elements in the process. Alternate implementations are included within the scope of the embodiments described herein in which elements or functions may be deleted, executed out of order from that shown, or discussed, including substantially concurrently or in reverse order, depending on the functionality involved as would be understood by those skilled in the art.

[0421] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “aprocessor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0422] Many variations and modifications may be made to the above-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure.

Claims

WHAT IS CLAIMED IS:

1. A medical device comprising: a fluid chamber configured to contain fluid; a plunger comprising a stopper and a plunger housing configured to be moveable within the fluid chamber; a pressure sensor disposed at least partially within the plunger such that the pressure sensor is configured to be in fluid communication with the fluid chamber; a calibration sensor configured to generate calibration data; and a controller in electrical communication with the pressure sensor, the controller configured to: receive, from the pressure sensor, pressure data while the fluid chamber is in fluid communication within an interior of a patient; receive, from the calibration sensor, the calibration data; generate a pressure reading based on the pressure data and the calibration data, wherein the pressure reading is indicative of a pressure of the interior of the patient; transmit the pressure reading to a display interface; and cause the display interface to display the pressure based on the pressure reading.

2. The medical device of Claim 1, wherein the plunger housing comprises: a body comprising: a track disposed axially along an exterior of the body; a display aperture configured to allow viewing of a display of the pressure of the interior the patient; and a button configured to be operably coupled with electronics of the medical device; a head at a distal end of the plunger; and a neck forming a circumferential recess between the body and the head of the plunger housing, the circumferential recess configured to couple with a circumferential flange of the stopper.

3. The medical device of Claim 2, further comprising a finger flange comprising a flange housing configured to be fixedly coupled about a chamber flange of the fluid chamber, the flange housing configured to fixedly house a magnet therein, wherein the flange housing comprises a protrusion configured to couple to the track of the plunger housing and to prevent rotation of the plunger relative to the magnet about a fluid axis.

4. The medical device of Claim 3, wherein the stopper comprises: a distal surface configured to be in contact with the fluid and to drive the fluid into or out of the fluid chamber, the distal surface forming an aperture within a center of the distal surface of the stopper, the aperture being generally disposed about the fluid axis; and a circumferential flange disposed at a proximal end of the stopper, the circumferential flange forming a collar configured to couple about a neck of the plunger housing.

5. The medical device of Claim 4, wherein a fit of the stopper is configured to result in simultaneous contact between a head of the plunger housing and each of a proximal interior surface and a distal interior surface of the stopper, forming a second fluid seal configured to prevent fluid ingress into an interior of a body of the plunger housing for pressures below a threshold pressure at a surface of the stopper.

6. The medical device of Claim 1, wherein the pressure sensor is further configured to: be in contact with a proximal interior surface of the stopper; include a face having a normal parallel to a fluid axis, the face configured to be recessed within an aperture of the stopper such that a column of fluid forms within the aperture of the stopper at the face of the pressure sensor; and generate a plurality of pressure signals in response to a fluid pressure within the fluid chamber.

7. The medical device of Claim 1, wherein the calibration sensor comprises a proximity sensor comprising a Hall effect sensor disposed within the plunger housing, the Hall effect sensor configured to generate proximity data based on a distance between the Hall effect sensor and a magnet.

8. The medical device of Claim 7, wherein the magnet is configured to be housed in a flange housing.

9. The medical device of Claim 1 , wherein the calibration sensor comprises an accelerometer configured to generate orientation data indicative of an orientation of the fluid chamber relative to Earth’s gravitational field.

10. The medical device of Claim 9, wherein the controller is further configured to: receive, from the accelerometer, the orientation data; and generate, based on the orientation data, orientation data indicative of the orientation of the fluid chamber relative to Earth’s gravitational field.

11. The medical device of Claim 10, wherein generating the pressure reading is further based on the orientation data.

12. The medical device of Claim 1, wherein the controller is further configured to: generate, based on the calibration data, fluid level data indicative of a fluid level within the fluid chamber.

13. The medical device of Claim 12, wherein generating the pressure reading is further based on the fluid level data.

14. The medical device of Claim 1, wherein the pressure sensor is disposed: between a distal end of the fluid chamber and the display interface; and between the distal end of the fluid chamber and a power source.

15. The medical device of Claim 1, wherein the medical device is configured to at least partially form a composite fluid chamber having a measurable pressure throughout the composite fluid chamber at hydrostatic equilibrium, the composite fluid chamber comprising: the fluid chamber of the medical device; and an interior of the patient.

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