HK1197379A - Contact lens cleaning system with monitor - Google Patents

Abstract

The invention monitors the neutralization process involving hydrogen peroxide solution and a hydrogen peroxide neutralization catalyst and compares measured values with theoretical values. The system monitors the chemical reaction and notifies the user of the neutralization status. In an exemplary embodiment, the initial hydrogen peroxide solution concentration is neutralized with a palladium catalyst after a period of time. A microcontroller analyzes the measurements and displays the neutralization process results using colored LED lights and/or text or images on a LCD display. In one embodiment, an apparatus adapted for use with a cleaning solution used to clean a medical device may include a trigger, a processing device in communication with the trigger, and a display device. The processing device provides a trigger count and the display device communicates with the processing device and displays a message based on the count.

Description

Contact lens cleaning system with monitor

Cross Reference to Related Applications

This patent application claims benefit from united states provisional application No. 61/445,910 filed on 23/2/2011 and united states provisional application No. 61/547,598 filed on 14/10/2011. The above-mentioned patent applications are hereby incorporated by reference in their entirety.

Is incorporated by reference

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Technical Field

The present invention relates generally to systems for cleaning and disinfecting contact lenses, and methods of using the same. In various aspects, the present invention relates to systems that use a reaction sensor to monitor the cleaning solution neutralization process and compare the measured values to theoretical values. The present invention determines whether the process is normally performed according to the measured value obtained by the reaction sensor and informs the user of the neutralized state.

Background

There are two main types of contact lens chemical disinfection systems, which are versatile and hydrogen peroxide based systems. Hydrogen peroxide based systems are generally preferred due to their rapid killing of microbial contaminants, preservative-free packaging, low user sensitivity, and neutralization to natural byproducts (e.g., water and oxygen). A disadvantage of hydrogen peroxide based systems is that they require memory of when the disinfection time starts and a calculation of the time at which the neutralization process is completed. At the same time, if too much time has elapsed since the hydrogen peroxide solution was neutralized, the sterile solution eventually re-infects and promotes microbial growth. One of the main reasons users have shifted from hydrogen peroxide based systems to multi-use is because hydrogen peroxide based systems require the user to calculate the ideal time of use for each disinfection of their contact lenses without knowing the effectiveness of the platinum catalyst work; i.e., an elapsed time sufficient to ensure complete neutralization of the peroxide to avoid chemical conjunctivitis and keratitis, and a short enough elapsed time to ensure that the microorganisms have not re-infected the sterile solution.

An example of a contact lens cleaning and disinfecting system is described in U.S. patent No. 4,687,997. The cleaning system entails inserting the lens into a disinfecting solution for a predetermined period of time and then inserting a neutralizing solution for a second predetermined period of time. The first indicator light displays a steady light when the disinfectant is in the cleaning cartridge and the second indicator light when the neutralizing solution is in the cartridge. The system distinguishes the sanitizing liquid from the neutralizing solution by measuring the conductivity of the solution in the cleaning cartridge. After a predetermined amount of time, both lights flash to indicate that the item has been sterilized and neutralized, respectively. However, the system does not monitor the efficacy of cleaning, disinfection, or solution neutralization; the indicator lights flash to show separately that the disinfection and neutralization cycle is complete over time.

Another example of a cleaning and disinfecting system is described in U.S. patent No. 6,183,705. The system uses ultrasound to clean the contact lens and heat to disinfect the contact lens solution medium. The system includes a housing, a control circuit assembly, an ultrasonic waveguide, a heating rod with two electrodes, and a graduated cleaning cup operated using an automated control circuit. The control circuit includes a microprocessor for controlling the heating rod and the ultrasonic waveguide. The microprocessor operates the ultrasonic transducer for a predetermined time and then stops. After the dwell time, the microprocessor heats the cleaning solution to a predetermined temperature of 90℃, as measured by the temperature sensor, and then turns off the heating rod to soak the lens in the hot solution for an additional predetermined time. Again, the system does not monitor the efficacy of the cleaning solution; the cleaning process is always performed along the same predetermined time interval and the indicator light only shows the stage at which the cleaning process is performed.

Summary of the invention

The present invention cleans and disinfects soft (hydrophilic) and hard gas permeable contact lenses using hydrogen peroxide solution and performs peroxide neutralization using a platinum disk. Neutralization is necessary to convert hydrogen peroxide to water and oxygen so residual solution on the contact lens does not irritate the eye during contact lens insertion. The system monitors the cleaning fluid within the device and directs the user through the contact lens cleaning process using lights and/or text cues.

The system may also monitor internal and external temperatures and confirm that the hydrogen peroxide solution is properly neutralized. Monitoring is achieved by confirming that the exothermic peroxide-neutralization process is performed at an acceptable rate. Reasons for poor neutralization may include old or expired peroxide solutions, improper storage of cleaning solutions, extreme solution temperatures, or reduced catalytic capacity of the platinum disk. The device can determine whether the user has accidentally used a bottle of saline solution in place of a bottle of hydrogen peroxide solution. If a vial of saline solution is used instead of a vial of hydrogen peroxide solution, cleaning and disinfection of the contact lens will not occur, increasing the risk of eye infection. In addition, the device minimizes the need to rinse the contact lens with saline solution after cleaning and prior to insertion into the eye; chemical conjunctivitis or keratitis can result if hydrogen peroxide is mistakenly used to replace the saline solution.

The present invention relates generally to apparatus for cleaning and disinfecting a contact lens. Apparatus, systems, and methods are provided for use with a cleaning solution for cleaning a medical device, wherein one or more messages are displayed that facilitate compliance with a conventional medical device cleaning protocol.

The following embodiments, aspects and variations thereof are exemplary and illustrative, and are not intended to limit the scope.

In one embodiment, a contact lens cleaning system comprises a contact lens holder; a vial adapted to contain a contact lens holder and a cleaning solution; a reaction sensor adapted to monitor a chemical reaction rate of the cleaning fluid; a processing device in communication with the reaction sensor to receive a reaction signal from the reaction sensor; and a display in communication with the processing device, the processing device adapted to operate the display to provide cleaning efficacy information based on the response signal. The catalyst element may be disposed within the vial and adapted to react with the cleaning solution. The reaction sensor may be a temperature sensor. The temperature sensor may be provided in the end cap covering the vial or outside the vial. The processing device may be adapted to determine the rate of temperature change from the response signal.

In embodiments, the system can determine cleaning efficacy by comparing the rate of temperature change to a theoretical rate of temperature change. The system may include an ambient temperature sensor disposed outside the vial, and may measure the temperature of the air surrounding the vial. The processing device may display cleaning efficacy information based on a temperature signal from the ambient temperature sensor. The system may include a usage counter in communication with the processing device. The processing device may display cleaning usage number information corresponding to the cleaning system.

The reaction sensor may be a pressure sensor. The system may include an outer box carrying the vials. The display may be disposed within the outer case. The display may be provided on an end cap on the vial. The system may include a solution sensor disposed within the vial. The processing device may determine the presence of the cleaning solution within the vial based on the signal from the solution sensor. The solution sensor may comprise an electrode and/or a capacitive sensor.

In another embodiment, a method of cleaning a contact lens and displaying cleaning efficacy information includes receiving a contact lens in a contact lens holder, receiving a cleaning solution in a vial, wherein the vial contains the contact lens and the contact lens holder, determining a chemical reaction rate of the cleaning solution and cleaning efficacy information based on the chemical reaction rate, and displaying the cleaning efficacy information.

The vial may further comprise a catalyst, and the chemical reaction rate may comprise a chemical reaction rate between the cleaning fluid and the catalyst. The determining step may include monitoring the temperature, monitoring the temperature of the cleaning solution, monitoring the temperature outside the vial, calculating a rate of temperature change, comparing the rate of temperature change to a theoretical rate of temperature change, and/or monitoring the temperature within the vial.

The method may include monitoring an ambient temperature outside the vial such that the determining step includes determining the chemical reaction rate based on the temperature inside the vial and the ambient temperature. The method may include counting contact lens cleaning uses and may display information related to the number of contact lens cleaning uses. The determining step may include monitoring the pressure within the vial. The method may include determining whether the vial has cleaning solution prior to the step of determining the rate of the chemical reaction.

In another embodiment, an apparatus can include a cap assembly configured to be connected to a contact lens cup, a contact lens holder extending from the cap assembly to the cup, a solution sensor connected to the cap assembly and configured to determine the presence of a solution in the cup, and a first temperature sensor connected to the cap assembly, a display, and a microcontroller within the cap. The microcontroller may be in communication with the solution sensor, the first temperature sensor, and the display.

The solution sensor may be a pair of electrodes that measure conductance or a capacitive sensor. The apparatus may include a catalyst for neutralizing the solution, and the solution may be hydrogen peroxide. The first temperature sensor may be a thermocouple or a thermistor and may be arranged to measure the temperature of the solution or the air surrounding the cup.

The apparatus may comprise a second temperature sensor. The second temperature sensor may be configured to measure the temperature of the air surrounding the cup and may be in communication with the microcontroller. The microcontroller may be adapted to receive conductivity data from the electrodes, solution temperature data from the first temperature sensor, and air temperature data from the second temperature sensor. The microcontroller may output a signal according to the data.

The signal output by the microcontroller may drive an LED on the display and may provide a text display on the display.

The text display may be provided by a liquid crystal display. A capacitive touch sensor can be connected to the end cap assembly. The device may include a battery to power the microcontroller.

In another embodiment, a method of cleaning a contact lens and displaying the status of the cleaning process can comprise receiving a contact lens in a contact lens holder. A contact lens cleaning solution can be received in a contact lens cup and a determination can be made as to whether there is cleaning solution in the cup. If the cleaning liquid is present in the cup, the method may include measuring a temperature of the cleaning liquid. The state of cleaning can be determined based on the temperature of the cleaning liquid. The state of cleanliness can be displayed.

The temperature of the air surrounding the cup can be measured. The status of cleaning can be determined from the measured air temperature and displayed on an LED display. The status may be displayed on a message display. Determining the state of cleanliness can include measuring electrical conductivity in the cup. Monitoring of the cleaning fluid may be initiated by a capacitive touch sensor.

In another embodiment, an apparatus for cleaning and disinfecting a contact lens can include a cap assembly, a contact lens holder, a cleaning fluid, a catalyst, a first temperature sensor, a display, and a microcontroller. The end cap assembly is configured to be attached to a contact lens cup. The contact lens holder extends from the end cap assembly to the cup. The cleaning fluid is contained in the cup. The catalyst is contained in the cup and is configured to neutralize the cleaning fluid. A first temperature sensor is connected to the end cap assembly. A microcontroller is in the end cap and is in communication with the first temperature sensor and the display.

In another embodiment, an apparatus, system, and method are provided for cleaning a medical device with a cleaning fluid, wherein one or more pieces of information are displayed. The information may inform the user of the cleaning protocol or conditions of the cleaning system and may facilitate compliance with an appropriate cleaning protocol, including information regarding when the medical device may be safely used, when the cleaning system should be replaced, and in some cases, consult a healthcare professional.

Another embodiment provides an apparatus adapted for use with a cleaning fluid to clean a medical device, the apparatus comprising a trigger, a processing device in communication with the trigger and which provides a count of trigger activation times, and a display device in communication with the processing device, wherein the display device displays information based on the count. In certain embodiments, the medical device may be a contact lens. For example, the display device may display the message "please change cassette and solution" when certain counts are reached, for example when the count is 180, which may be the count commonly used on a six month day basis.

Another embodiment provides an apparatus adapted for use with a cleaning fluid to clean a medical device, and may include a sensor to measure a property of the cleaning fluid or a nearby area or medical device; a processing device in communication with the detector; a display device in communication with the processing device, wherein the display device displays information based on the properties of the cleaning fluid or the nearby area or the medical device. In certain embodiments, the cleaning solution comprises hydrogen peroxide. In certain embodiments, the medical device is a contact lens. In certain embodiments, the sensor is a temperature sensor, an electronic sensor, a pressure sensor, an acoustic sensor, an optical sensor, or a gas sensor. In certain embodiments, the processing device compares the input signal from the sensor to one or more predetermined values and provides one or more output signals based on the comparison to the display device. In certain embodiments, the display device is a lamp (e.g., an LED) or a liquid crystal display.

Another embodiment provides an apparatus adapted for use with a cleaning fluid for cleaning a medical device, comprising a temperature sensor that measures a temperature profile of the cleaning fluid or a nearby area during a cleaning cycle; a processing device in communication with the temperature sensor and storing the acceptable temperature profile in a memory; a timer; and a display device in communication with the processing device, wherein different messages are displayed on the display device depending on whether the temperature distribution measured by the temperature sensor falls within or outside an acceptable temperature distribution range.

Another embodiment provides an apparatus adapted for use with a cleaning fluid for cleaning a medical device and providing a message to a user, comprising a device for measuring a property of the cleaning fluid or a nearby area or the medical device; a processing device for ((a)) receiving an input signal; ((b)) providing a comparison of the input signal with one or more predetermined values; and ((c)) providing one or more output signals based on the comparison; and means for displaying a message, wherein the message is based on the output signal.

Another embodiment provides a method of monitoring patient compliance with a protocol for cleaning a medical device with a cleaning solution, the method comprising obtaining data by measuring a property of the cleaning solution or a nearby area or the medical device, and displaying one or more messages based on the data. In some embodiments, the data may be provided to a medical professional.

Drawings

The novel structure of the invention is set forth with particularity in the following claims. The structure and advantages of this invention will be better understood by reference to the following detailed description that illustrates exemplary embodiments, in which the principles of the invention are utilized, and the accompanying drawings, in which:

figures 1A-1B illustrate an exemplary contact lens storage system. (ii) a

Figures 2A-2B illustrate another exemplary contact lens storage system. (ii) a

Fig. 3 shows an exemplary operational flow diagram. (ii) a

Figures 4A-4B illustrate another exemplary contact lens storage system. (ii) a

Fig. 5 illustrates another exemplary operational flow diagram. (ii) a

Figures 6A-6B illustrate top and side views, respectively, of another contact lens storage system. (ii) a

Figure 7 shows a side perspective view of a contact lens cleaning box and monitor. (ii) a

Figure 8A shows a side view of a contact lens end cap, lens basket and platinum catalyst. (ii) a

Figure 8B illustrates a top perspective view of a contact lens endcap illustrating the primary internal components. (ii) a

Figure 8C illustrates another top perspective view of a contact lens endcap illustrating an LED configuration. (ii) a

Figure 8D illustrates another top perspective view of a contact lens endcap, showing an LCD configuration. (ii) a

Fig. 9 shows the rate of temperature rise of the solution over time. (ii) a

Fig. 10 shows the rate as a function of the initial solution temperature. (ii) a

FIG. 11 shows the determination of equation slope and y-intercept. (ii) a

Figure 12 shows the determination of the rate at which air heats the solution in the contact lens case. (ii) a

Fig. 13 shows an example of thermistor RC time versus temperature transition. (ii) a

Fig. 14 shows a block diagram of a cleaning device for a medical device. (ii) a

Fig. 15 shows a block diagram of an exemplary temperature sensing contact lens cleaning cartridge. (ii) a

FIGS. 16A-16B illustrate another exemplary operational flow diagram. (ii) a

Figure 17 illustrates another exemplary contact lens storage system. (ii) a

Fig. 18A-18B show side and top views, respectively, of the cleaning cartridge of fig. 17.

Detailed Description

The present invention relates to systems and methods for monitoring the efficacy and status of contact lens cleaning processes, such as systems using hydrogen peroxide and a neutralization catalyst. It is an object of the present invention to provide the user with an improved determination of when the catalyst has reduced the peroxide concentration sufficiently to allow insertion of a contact lens into the eye. The improved determination (traditionally made solely on elapsed time and uncalibrated solution temperature) can greatly reduce the risk of peroxide accidentally burning the eye causing chemical conjunctivitis. Accidental burns can be caused by improper use of the hydrogen peroxide disinfection system, use of expired peroxide solutions, improper storage of the disinfecting solution, extreme disinfecting solution temperatures, rinsing the contact lens with hydrogen peroxide prior to insertion, or use of platinum catalysts with low catalytic capabilities.

Without knowing the effectiveness of the platinum catalyst in neutralizing the cleaning solution, the user needs to calculate a safe use time for each instance of disinfecting his contact lens. That is, the user needs to determine whether the elapsed time is sufficient to ensure complete neutralization of the peroxide to avoid chemical conjunctivitis, and short enough to ensure that the microorganisms have not re-infected the sterile solution. The invention automatically calculates for the user, so the user does not need to do; and the device evaluates the effect of the chemical reaction that takes place during neutralization.

The system includes a cap assembly configured to be connected to a contact lens cup or vial. Examples of cleaning cartridges comprising an end cap and a contact lens cup or vial are well known in the literature and may include other structures not shown herein. Examples of such cassettes can be found in U.S. patent nos. 4,637,919, 4,750,610, 5,186,317, 5,366,078, 5,558,846, 5,609,284, 5,609,837 and 6,148,992. Commercial examples of such boxes can be found in or asDisposable cup and disc (Shikang (, (v))) ))) and(Shikang (, (A)) ) portion of the system.

A solution sensor may be connected to the end cap assembly and configured to determine that a solution is present in the cup. In some embodiments, the system may include a reaction sensor. The reaction sensor may be adapted to monitor a chemical reaction rate of the cleaning fluid. The reaction sensor may be implemented as a temperature sensor, an electrical sensor, a pressure sensor, an acoustic sensor, an optical sensor, or a gas sensor. The system may include a first temperature sensor and a display coupled to the end cap assembly. The first temperature sensor may be implemented with a first reaction sensor and may be configured to measure a temperature of the solution. The system may further comprise a second reaction sensor in the form of a second temperature sensor configured to measure the temperature of the air surrounding the cup. The end cap assembly may include a microcontroller. The microcontroller may be in communication with the reaction sensor, the solution detector, the capacitive touch sensor, the solution sensor, the first temperature sensor, the second temperature sensor, and/or the display, and send an output signal based on the data.

In certain aspects, the devices, systems, and methods described herein may have the following advantages. In certain aspects, they can provide a convenient reminder to the user as to whether cleaning is or is not occurring properly, when the medical device can be safely used, or when the medical device should be replaced. In embodiments where the apparatus, systems or methods are used with contact lens cleaners, they may improve user compliance with processes that clean contact lenses and improve the safety and cleanliness of the lenses. In certain aspects, the use of the devices, systems, and methods described herein can increase the likelihood of proper lens cleaning, can reduce the likelihood of re-infection of a contact lens after a cleaning process, or can reduce the likelihood of eye irritation after lens cleaning. For example, for devices in which a hydrogen peroxide-based cleaning solution is used, the devices described herein can indicate to the user whether the solution is effective (i.e., whether there is sufficient peroxide in the solution to clean the lens within a specified time), whether a normal cleaning cycle is complete and the lens can be safely placed in the eye, whether the catalyst used to consume the hydrogen peroxide is functioning properly or needs to be replaced, and other aspects of the cleaning protocol. In yet another aspect, the apparatus described herein for use with a contact lens cleaning system can display a signal or message that the user should consult their optician or eye care professional. In certain aspects, use of the contact lens storage systems described herein can increase patient or user compliance with normal lens cleaning regimens or other aspects of their eye care. While some of the foregoing advantages relate to contact lens cleaning systems, these advantages also relate to corresponding apparatus, systems, and methods suitable for cleaning other medical devices, including dentures, endoscopes, catheters, ports, and the like.

The term "caddy" refers to an apparatus suitable for use with a cleaning solution for cleaning a medical device. In certain embodiments, the outer cartridge can be a device into or onto which a separate cleaning cartridge is removably placed. In other embodiments, the outer box may also be a cleaning box, i.e. a part into which the cleaning liquid can be poured directly.

The term "rinsing fluid" refers to any liquid cleaning or disinfecting fluid used to clean medical devices, such as contact lenses. The cleaning fluid may or may not include hydrogen peroxide or other peroxide compounds. The cleaning fluid may also include other ingredients. Examples of cleaning fluids that may be used in accordance with the systems described herein include (but are not limited to)Disinfectant (Shikang (A and B)) ))) and(Shikang (, (A))））。

The term "cleaning system" refers to the cleaning liquid and accompanying equipment, such as a catalyst for consuming hydrogen peroxide in a peroxide-based cleaning liquid.

The term "property" refers to a physical, chemical, electrical, optical, or other property, as well as the distribution of that property over time.

Definitions of terms used are standard definitions used in the fields of organic synthesis and pharmaceutical science, unless specifically indicated otherwise herein. Exemplary embodiments, aspects and variations are illustrated in the accompanying drawings, and the embodiments, aspects and variations, as well as the drawings disclosed herein, are intended to be illustrative, not limiting.

FIGS. 1A-B show outer cartridge 150 and cleaning cartridge 110. Referring to fig. 1A, the outer box 150 includes an outer box housing 151, an indicator lamp 152, and a display panel 154. The outer box housing 151 can be made of a suitable material, such as plastic or similar types of materials, which are well known in the art. The indicator light 152 may be a lamp or LED (light emitting diode) and the display panel may be an LCD (liquid crystal display) or similar display panel capable of displaying color or black/white/grayscale text and/or graphic images. The display may be an indicator light, such as a light or LED, or a display panel such as an LCD. These components and structures are also well known in the art.

In some embodiments, outer box 150 can include mechanisms for providing audio prompts for solution status, temperature monitoring, and other information. For example, the cartridge housing may include one or more speakers and a controller or processor. The one or more speakers may output audio from an acoustic signal provided by a controller or processor. A controller or processor may receive temperature or other data from one or more sensors. The audio message may be provided based on data provided by the sensor. For example, cartridge 150 may provide audio alerts indicating time remaining in the neutralization process, completion of the neutralization process, that the cartridge has disinfected contact lenses, that disinfection was successful or unsuccessful, that no solution was detected, and other messages. Thus, the system of the present invention may provide audio alerts instead of or in addition to visual or tactile alerts to communicate events or conditions related to contact lenses, solutions, and other aspects of the present technology.

Referring to FIG. 1B, a cleaning cartridge 110 is shown, both individually and partially disassembled. The cleaning cartridge 110 includes elements such as an end cap 112, a load beam 114, a basket 116 and catalyst 118, and a cylinder 120. Contact lens 117 is also shown. Examples of cleaning cartridges are well known in the literature and may include other structures not shown herein, or modifications to the structures shown herein. As shown, cleaning cartridge 110 may be fully assembled on cylinder 120 by reversibly securing end cap 112 (e.g., by screwing, snapping, a positive fit, a friction fit, etc.). The barrel 120 of the embodiment shown in fig. 1B includes threads or screws 3 for securing the end cap 112. The barrel 120 of the embodiment shown in fig. 1B includes threads or screws 3 for securing the end cap 112. Once fully assembled, the cleaning cartridge is removably placed in or on the outer casing.

Referring to FIG. 2A, outer box 150 is shown in a perspective side view, with outer box housing 151, indicator lights 152, and display panel 154 also shown. Fig. 2B shows a cross-sectional view of the sleeve 150 and trigger 160, which is electronically connected to a processing device 170 that is connected to and powered by a power source 180. The processing device 170 is also electronically connected to the indicator light 152 and the display panel 154. The trigger 160 is positioned such that it trips under normal operation when the cleaning cartridge 110 is placed in or on the outer casing 150. The trip trigger advances a counter within the processing device to provide a count. The processing device 170 may be a logic circuit, an integrated circuit chip, or a microprocessor, such as a computing chip, or a plurality or combination thereof. Similarly, the processor may take the form of a logic circuit, an integrated circuit chip, or a microprocessor, such as a computer chip, or a plurality or combination thereof. The power source 180 may be a battery, such as a rechargeable battery or other type of battery commonly used in small electronic devices. In some embodiments, the power source may be a power source external to the enclosure, such as a household 110V or similar power source. A small transformer is not shown and may be necessary.

Referring to FIG. 3, various aspects of the operation of certain embodiments of the caddy are illustrated. After the contact lens and rinsing fluid are placed in the cleaning cartridge (e.g., cleaning cartridge 110, FIG. 1A), the process begins at step 301. At this time, the completely assembled cartridge should be placed in the base unit. In step 302, the trigger (e.g., trigger 160, figure 2B) and its associated processing device (e.g., processing device 170, figure 2B) may be used to determine whether the contact lens case is placed in the base unit. In step 304, if a cleaning cartridge is placed therein, a counter in the processing device may count in one; otherwise, in step 303, the system may be placed in a "standby" mode. If the count reaches some predetermined indicator in step 305, the system may display a message such as "please replace cassette and solution" in step 307. The predetermined indication or other value may be stored in a memory unit, which may be part of the processing device.

For example, if the lens cleaning cartridge and solution typically have a useful life of about six months, the indicator value may be set to 180 (assuming cleaning every day for six months). Other indication values may be set, multiple indication values may be set for different messages, and the indication values may vary. When the count reaches the indicated value, the system can display an appropriate message to the user to facilitate use of the new cleaning cartridge and solution, thereby improving compliance with the appropriate lens cleaning protocol. The process is represented by step 308. At this point, the system may be reset, i.e., the counter may be reset to a zero value, for example by the user pressing a button or switch (not shown) on the base unit or by an external computing device (also not shown). Referring back to step 305, if the indicator is not reached, the user may continue normal operation of the cleaning system in step 306 and may use it for subsequent cleaning.

The message may be in the form of a light, such as from an LED or similar light, an audible signal, such as a clock, bell, recording, etc., a tactile signal, such as a blind message, or an indication to display other signals. In one embodiment, a red light is displayed when the indicator value in the processing device is reached. In another embodiment, a green light is displayed before the indicator value is reached, and when the indicator value is reached, the green light is turned off and the red light is turned on. Similarly, when the indicator value is reached, an audio signal such as a bell, clock or suitable recording may be triggered.

The message may also take the form of a text message or a graphical description that may be displayed on the LCD. An example of a text message is "please change cassette and solution" which may be displayed when the counter reaches some predetermined value, indicating that the service life of the solution and/or catalyst is about to end. One example of a graphical depiction is a graphical representation of a cleaning cartridge or a bottle of cleaning fluid. Further examples and details of the messages are described below.

Further examples of messages include: "thank you using a cleaning care lens solution"; "protection of eyes and trust"; "your contact lens is disinfected"; "your contact lenses take six hours to use; "your contact lens is ready"; "please wash hands with soap and water before removing them"; "because the solution is no longer active, please discard the contact lens solution"; "your corneal contact lens case has been purchased for six months. Please consult an optometrist. "

In various embodiments, the contact lens storage system can measure ((a)) the cleaning solution, ((b)) the vicinity (also referred to as the vicinity) of the cleaning solution (e.g., gas headspace above the cleaning solution), or ((c)) a property of one or more medical devices to be cleaned. Examples of cleaning fluid properties include temperature, conductivity, color, uv/vis absorption and distribution (e.g., temperature, time, etc.). Examples of nearby area properties include pressure, sound (e.g., sound generated by foam collapse of the solution/air interface), temperature, and distribution thereof. Examples of medical device properties include diffraction, dispersion, or other properties. Such measurements may be the basis of one or more messages as to whether the cleaning fluid is effective, working properly, needs to be replaced, whether the lens is clean and ready to be removed for use, etc., by known calculations and/or comparisons in the processing device.

Fig. 4A and 4B illustrate an embodiment of a contact lens storage system 400 showing a cleaning cartridge 110 removably placed in a base unit 450 (also referred to herein as an outer cartridge). Referring to fig. 4A, in this embodiment, a base unit housing 151 (also referred to herein as a box housing) and a display panel 154 are shown, as described above. In this embodiment, there are also two indicator lights 152A and 152B, which may be, for example, red and green lights, as described above. Depicted in dashed lines in this figure are power supply 180 (as described above), temperature sensor 492, and circuit board 495.

Fig. 4B shows cleaning cartridge 110 removably placed in base unit 450 of contact lens storage system 400, with certain structures hidden from view and certain other structures described herein. When the cleaning cartridge 110 is inserted into the base unit 450, the trigger 460 may be tripped and the roller 461 may be deflected downward. The rollers 461 may be balls, discs or similar components. The trigger 460 may be, for example, a mechanical switch (such as shown in fig. 4B) or an optical switch such as a combination of an LED IR emitter and a light detector (not shown). The temperature sensor 492 can be configured to monitor the temperature or temperature change (i.e., temperature profile) of the cleaning fluid during a cleaning cycle. An optional thermistor 494 can be present in certain embodiments for measuring a nearby temperature (e.g., a temperature outside the cleaning cartridge). The trigger 460 and the temperature sensor 492 are connected to the processing device 170 and are both powered by the power source 180. In this embodiment, the processing device 170 is also connected to the port 490. Port 490 may be, for example, a USB port that connects the system to a computer, smart phone, or similar device. Wireless connectivity may also be used (e.g.）。

Generally, when hydrogen peroxide is introduced into the cleaning cartridge 110 containing the catalyst 118, a chemical reaction occurs in which the catalyst is chemically reduced, thereby consuming the peroxide. It is recommended to consume the peroxide completely before the lens is inserted into the eye, as traces of peroxide can also cause pain to the eye. Heat is generated during the chemical reaction. The rate and extent of temperature increase during the reaction and decrease after the reaction can be measured and is a function of the amount of peroxide in solution and the amount of catalyst available, since the catalyst species, typically a metal such as platinum, is also oxidized during the reaction. Thus, in one embodiment, the temperature change or temperature profile (i.e., the shape of the temperature versus time curve) of the cleaning solution may be correlated to a change in the quality of the cleaning solution (e.g., the amount of peroxide present) or catalyst (e.g., the amount of catalyst still available). The processing device can then be programmed to compare the temperature or temperature profile to a predetermined value. Thus, different messages may be displayed on the display device depending on whether the temperature distribution measured by the temperature sensor falls within or outside the acceptable temperature distribution range.

Referring to fig. 5, various aspects of the operation of certain embodiments of a contact lens storage system are illustrated. After the contact lens and rinsing fluid are placed in the cleaning cartridge (e.g., cleaning cartridge 110, FIG. 4B), the process begins at step 501. At this time, the cartridge should be inserted into the base unit. In step 502, a trigger (e.g., trigger 460, figure 4B) and its associated processing device may be used to determine whether the contact lens case is placed in the base unit. If a cleaning cartridge is placed therein, a message, such as "sterilizing" may be displayed on a display panel (e.g., display panel 154, FIG. 4A) in step 503. If the cleaning cartridge is not placed in the base unit, the display panel may display a message such as "standby" and the base unit may be in a so-called "standby mode" in step 507. After the trigger trips, the temperature profile of the solution in the cleaning cartridge may be measured in step 504 to determine if it falls within an acceptable temperature profile. If "no," a message such as "sterilization was unsuccessful" may be displayed in step 505. Please replace the cartridge and solution. ", the box may then be removed in step 506, and a" standby "message may be displayed in step 507. If the temperature rise is found to be within an acceptable range, then in step 508, a timer begins counting a predetermined minimum disinfection time (("MDT")) for normal disinfection of a pair of contact lenses. At this point, a "sanitize normal work" message may be displayed. In step 510, the message is still displayed as long as the elapsed time is not greater than the minimum disinfection time. Once the elapsed time (("ET")) equals the minimum disinfection time in step 510, a "lenses can be safely worn" or "disinfection complete" message can be displayed in step 511. For example, the minimum sterilization time may be set to 6 hours. Other minimum sterilization times may be based on, for example, the time required to measure the temperature profile, the size and shape of the lens case and catalyst, and the cleaning system (e.g., cleaning system)，Etc.) specified recommended minimum disinfection time, etc. If the cassette is removed in step 512, the base unit returns to the standby mode. If the cassette is not removed in step 512, the timer continues to count. When the elapsed time measured by the timer reaches a predetermined upper limit of a safe storage time (("SST") in step 514, a message such as "please restart the disinfection process" may be displayed in step 515; otherwise, a "lenses may be safely worn" message is still displayed. For example, the upper limit of SST may be about 18 hours, about 24 hours, about 7 days, or other times, depending on the cleaning system used. Since the risk of re-infection may increase after this time, it may be desirable to remove the lens from the cleaning box before this time. One of ordinary skill in the art will appreciate that the processing device may include one or more memory units, may store values such as elapsed time, safe storage time, etc., and may perform the comparisons and calculations described above.

Referring to fig. 6A-B, an embodiment is shown in which the cartridge itself receives a cleaning solution (i.e., no separate cleaning cartridge is present). Referring to FIG. 6A, a side view of cartridge 800 is shown, including cartridge housing 851, indicator light 852, control buttons 853A and 853B, display 854, reservoirs 820A and 820B, and end caps 812A and 812B made of plastic or some other suitable material, which are reversibly secured (e.g., by screwing, snapping, a positive fit, a friction fit, etc.) to cartridge housing 851. Some of these components are shown in the side view of fig. 6B. The sleeve may include structures such as triggers, timers, processing devices, or power supplies that are shown in other embodiments, but not explicitly shown herein. The enclosures shown in fig. 6A-B may also include reaction sensors, such as temperature sensors, electronic sensors, pressure sensors, acoustic sensors, or gas sensors. For example, outer box 800 may include a temperature sensor of the type shown in FIG. 4B, or a pressure sensor of the type shown in FIGS. 17-18 (as in end caps 812A-B). The sleeve may also include a button or tab under the end cap receiving portion that is depressed when the end cap is reversibly secured to the sleeve. When pressed, a signal may be sent to the processing device to start a timer or display a message, similar to the trigger described above.

Figure 7 shows a side perspective view of a contact lens cleaning box and monitor in accordance with one embodiment of the present invention. The embodiment of fig. 7 has a contact lens cup 1 filled with a buffered hydrogen peroxide solution to a fill line 2.

Figure 8A shows a side view of a contact lens end cap, lens basket and platinum catalyst. The contact lens cup 1 is secured to the nut 4 of figure 8A using screws 3. The solution temperature sensor 5 monitors the solution temperature over time during the hydrogen neutralization process. In various embodiments, the solution temperature sensor 5 may be a thermistor or a thermocouple. Using the solution sensor 6, a microcontroller (not shown) senses that the contact lens is immersed in the solution and begins the monitoring process. The solution sensor 6 may comprise two electrodes, one of which is shown on the load beam of fig. 8A. The solution sensor 6 may be positioned adjacent or near the top of the lens basket 7 (not shown). The solution sensor may be a pair of conductive electrodes. In various embodiments, when sensing the presence of a solution using conduction, the microcontroller 11 may power one electrode and measure the current of the other electrode. If current flows from one electrode to the other, the microcontroller determines that the end cap is placed in solution. The solution sensor may also be a capacitive sensor. In various embodiments, the microcontroller may measure the capacitive load when the presence of the solution is sensed using the capacitive sensor. An example of a simple method of measuring capacitance is by using an RC circuit, where the charge and discharge times of the effective capacitor are measured by a microcontroller; the capacitance increase is correlated to the time increase. Examples of capacitive solution sensors can be found in U.S. patent nos. 2,409,073, 5,145,323 and 5,238,369.

A pair of contact lens baskets 7 hold the contact lens in place during the cleaning process. The platinum catalyst 8 neutralizes the hydrogen peroxide solution, which is an exothermic process. Basket hinge 9 allows contact lens basket 7 to be opened to allow contact lens insertion or removal.

Figure 8B shows a top view of a contact lens endcap showing the major internal components. The main internal components of the contact lens endcap may include a microcontroller 11, a response sensor such as an external temperature sensor 13, and a battery 12. The capacitive touch sensor 10 wakes up the microcontroller 11 from a low power sleep mode. A capacitive touch sensor 10 (typically used in a variety of handheld devices such as a mobile phone capacitive touch screen) may communicate with a microcontroller 11 to recognize a touch of a hand. The microcontroller 11 may measure the capacitive load of the touch sensor 10. When a conductive object, such as a finger, approaches the touch sensor, the capacitive load changes. Examples of touch sensors can be found in U.S. patent nos. 4,186,392, 4,736,191, and 5,650,597. The battery 12 powers the device.

The external temperature sensor 13 measures the temperature of the air surrounding the cup 1 and is calibrated for external heating or cooling of the solution. In various embodiments, the external temperature sensor 13 may be a thermistor or a thermocouple. An example of how the microcontroller 11 measures temperature by using a thermistor is the use of an RC circuit. A thermistor (for example of the 33k NTC-type), having a variable resistance with respect to temperature, can be connected to a capacitor parallel to a known fixed capacitance (for example 1000 pF). The microcontroller initially charges the capacitor to a certain high voltage (e.g., about 4.5V). When the initial voltage is reached, the charging process is stopped and the time for the thermistor to discharge the capacitor to a particular low voltage (e.g., about 1.4V) is measured. Since the resistance of the thermistor is temperature dependent, the temperature can be easily calculated by the microcontroller 11 from the time measurement between the high and low voltages. The measurement results of this example are shown in fig. 13.

In one embodiment, the microcontroller 11 may measure temperature by measuring the current generated by a thermocouple composed of two distinct thermoelectric properties using a thermocouple. The current is converted to a digital signal by an analog-to-digital converter for microcontroller processing. Since the current is temperature dependent, the microcontroller 11 can calculate the temperature from this current. Examples of thermocouples can be found in U.S. patent nos. 2,985,949 and 4,588,307.

Figure 8C shows a top view of a contact lens endcap illustrating a display constructed using LEDs. One or more of the LED colored lights 14 of fig. 8C represents the state of the solution. Figure 8D illustrates a top view of a contact lens endcap showing a display constructed using an LCD. The optional LCD display 15 may supplement or replace one or more LED lights that communicate to the user as to the status of the solution or device. The state of the solution or device may include the following text: "cleaning process of the solution being analyzed", "waiting for the solution to complete the cleaning process", "contact lenses can be safely inserted into the eye", "contact lenses cannot be safely inserted into the eye, please re-perform the cleaning process", "cleaning process is not functional, please change solution and/or cartridge" and "battery low". The prompting may be by one or more colored LED lights, e.g. red, yellow, orange, green and optionally a short message on an LCD display. The short message may include "battery", "wait", "yes", "go back", "bad", "use", "safe", "low", "clean", "analyze", "replace". In some embodiments, the prompt may be provided as an audio signal.

Example 1

The exothermic reaction monitored by the reaction sensor of the present invention can be illustrated by this embodiment. The corneal contact lens case is a plastic walled reaction vessel with a diameter of 20mm and a thickness of 2mm, such as shown in figure 7. The corneal contact lens case is thermally insulated from the environment to exclude external temperature effects. The cassette was filled with 10ml of a sterilizing solution (3% hydrogen peroxide, 0.85% sodium chloride, phosphoric acid and phosphate buffered solution) at an initial temperature of 20.0 ℃. The contact lens end cap contains a cogged platinum catalyst disk (equivalent to the common-10.4 cm2/1150 μ g platinum catalyst currently commercially available and used for contact lens care). The thermal gradient over time was recorded using an embedded thermocouple. For a 20 ℃ solution, the temperature was initially increased at a rate of about 1.5 ℃/minute. As the peroxide concentration of the solution decreases over time, the rate of temperature change (exothermic reaction) begins to slow. One competing event is the acceleration of the exothermic reaction with increasing temperature. The resulting reproducible temperature profile is shown in FIG. 9, which can be predicted using the mathematical formula:

rate ((20 ℃)) = rate of temperature change without influence of external air temperature (degrees centigrade per minute) when the solution is at 20 ℃.

The formula can also be expressed as:

rate ((20 ℃)) = ((0.00009 × time 3)) - ((0.0184 × time 2)) - ((0.0248 × time)) +1.5611

Wherein the time is the reaction time (minutes).

Although the curves appear to be polynomials, linear approximation can also be used to simplify the calculation:

rate ((20 ℃)) = ((-0.124 × time)) +1.6725

The above experiment was repeated at different initial solution temperatures. Fig. 10 shows the reaction rate depending on the initial solution temperature. As shown in fig. 10, the exothermic reaction depends on the initial temperature of the solution. The initial solution temperature decrease reduces the rate of temperature change over time, while the temperature increase accelerates the rate of temperature change over time. FIG. 11 shows the determination of equation slope and y-intercept. As shown in fig. 11, the slope and y-intercept of these plots are nearly linear with respect to the initial solution temperature. Thus, a simple mathematical calculation can be used to predict the rate of temperature change at any point in time given the initial solution temperature.

Rate ((1)) = rate of temperature change without influence of external air temperature (celsius/minute).

The formula can also be expressed as:

rate ((1)) = (((((((-0.008 × IST)) + 0.037)) × time)) + (((((0.039 × IST)) + 0.821))

Where IST is the initial solution temperature (degrees celsius) and time is the reaction time (minutes).

This can be easily calibrated since mathematical calculations cannot account for the outside air temperature that warms up the corneal contact lens case. The above experiments were performed at multiple ambient air temperatures. Figure 12 illustrates a determination of ambient air temperature versus the heating effect of a solution in a contact lens case during an exothermic disinfection process. It was found that this effect is linear with respect to the instantaneous temperature difference between the air temperature and the solution temperature. The cooling effect also fits this equation where the air temperature is lower than the solution temperature, but negative. Thus, the overall rate is:

rate ((2)) = rate of change in solution temperature without influence of exothermic neutralization reaction (degree centigrade/min) (rate of air heating solution)

The formula can be expressed as:

rate ((2)) =0.056 × ((CET-CST))

Where CST is the current solution temperature (degrees celsius) and CET is the current external temperature (degrees celsius).

The theoretical rate can then be calculated as the overall rate of change of the solution temperature. The theoretical rate can be expressed as:

theoretical rate = rate ((1)) + rate ((2))

Theoretical rate = ((-0.008 × IST + 0.037)) × time + ((0.039 × IST + 0.821)) +0.056 × ((CET-CST))

This formula only fits the specific contact lens case design, solution formulation, peroxide concentration, and catalyst design and quality. This is advantageous because abnormally high or low peroxide concentrations and/or platinum catalyst degradation can be easily identified by comparison of theoretical and actual temperature measurements.

The method of using the device can begin when the user places a contact lens in contact lens basket 7 of contact lens cap 4 and closes basket 7. The contact lens cartridge cup (reaction vessel) 1 is filled with hydrogen peroxide disinfectant/rinse up to the fill line 2. The contact lens end cap 4 is grasped by the hand of the user. The user's hand is sensed by the capacitive touch sensor 10, which wakes up the microcontroller 11 from the low power mode. The microcontroller 11 then monitors the solution sensor 6 to sense when the contact lens is immersed in the solution. For discussion purposes, conductive electrodes are used as examples of solution sensors. The exemplary solution sensor is not intended to be limiting. Microcontroller 11 can sense when the contact lens is immersed because the solution contains ions that allow electrons to flow from one electrode to the other. Since the conductive electrode 6 is located near or above the solution temperature sensor 5, the contact lens and the fill line 2, it is necessary to verify that sufficient solution is added to the contact lens cartridge cup (reaction vessel) 1. The conductive electrode 6 sends a signal to the microcontroller 11 to initiate monitoring of the contact lens solution and to turn on the reaction timer. For example, the microcontroller 11 may flash a yellow LED light 14 quickly, or cause the display to provide a message "analyze" on the LCD display 15. The microcontroller 11 may then make an initial solution temperature measurement ((IST)). In various embodiments, the microcontroller 11 can make solution temperature measurements using the solution thermistor or thermocouple 5 at 1.5 minutes and 0.5 minutes, and take the difference of these two numbers (actual rate); the microcontroller 11 also takes measurements ((CST)) at 1.0 minute (time = 1.0) using the solution thermistor or thermocouple 5 and ((CET)) using the external temperature sensor 13. The values may be used in the following exemplary formula:

theoretical rate = ((-0.008 × IST + 0.037)) × time + ((0.039 × IST + 0.821)) +0.056 × ((CET-CST))

For example, if the actual rate is within +/-20% of the theoretical rate, the device identifies that the solution and platinum catalyst are proceeding as expected; the device then slowly flashes the yellow LED light 14 or displays "clean" on the LCD display 15. For example, if the actual rate is not within +/-20% of the theoretical rate, the device identifies that the solution and platinum catalyst are not proceeding as expected; the device then flashes the red LED light 14 or displays "REDO" or "bad" on the LCD display 15.

If the device recognizes that the solution and platinum catalyst are proceeding as expected, a certain time is allowed to elapse, which is appropriate for complete hydrogen peroxide neutralization at a given solution temperature (about 6 hours at 20 ℃). At this point, the contact lens is considered ready to be worn, and the device can then slowly blink the green LED light 14 or display "use" or "safe" or "worn" on the LCD display 15. If the conductive electrode 6 and capacitive touch sensor 10 do not sense the removal of the screw cap 4 from the contact lens cup 1 containing the neutralizing solution, then the device can slowly blink the green LED lamp 14 until the contact lens cannot be safely placed in the eye at a given solution temperature (about 7 days at 20 ℃). At this point, the device then slowly blinks the red LED light 14 or displays "go again" on the LCD display 15.

The device may also count the time the cleaning process has been performed, flashing the red LED light 14 or displaying "bad" or "changed" on the LCD display 15 after a maximum number of uses has been exceeded. Audio cues may also be provided to indicate that the maximum number of uses has been exceeded. The device may also count the number of days elapsed after initial use and over a maximum number of days flash the red LED light 14 or display "bad" or "replace" on the LCD display 15.

Fig. 14 shows a block diagram of a cleaning device 700 for a medical device. The cleaning device 700 has a microcontroller 704 powered by a power supply 702. Microcontroller 704 controls and communicates with display/user interface 701, reaction sensor 703, and memory 705. The operating program and user data of the device are stored on the memory 705 and access information is required according to the microcontroller 704. The programming of the microcontroller may be initiated by a signal from the reaction sensor 703 or from the user through the display/user interface 701 (e.g., displaying a touch screen). The microcontroller 704 reads from the sensors over time, counts using the measurements and data stored in memory, and displays the results on the display/user interface 701.

Fig. 15 shows a block diagram of an exemplary temperature sensing contact lens cleaning cartridge 706. The cleaning cartridge 706 has a microcontroller 708 powered by a power supply 713. The microcontroller 708 monitors the solution sensor 711 to sense when a solution is present. When the microcontroller 708 determines that a solution is present, readings are taken from the air temperature sensor 709 and the solution temperature sensor 710. These readings, combined with calibration data stored in memory 712, are converted to temperature measurements by microcontroller 708. The microcontroller 708 then stores these historical temperature measurements in memory 712 for later retrieval. After a certain duration, the temperature measurement is retrieved by the microcontroller 708 from the memory 712. The microcontroller 708 determines the signal that should be sent to the display 707.

16A-B illustrate an example operational flow diagram for a three lamp LED display configuration. The operational flows described herein are for exemplary purposes only and are not intended to be limiting. In various embodiments, the process begins at step 720 when the cleaning cartridge (e.g., the cleaning vial of fig. 7 and the end cap of fig. 8A) is energized. In some embodiments, the device is typically in a low power sleep mode in step 721 to protect limited battery life. In step 722, the device may wake up from the low power sleep mode for a few microseconds every 1 to 3 seconds to sense whether cleaning fluid is added to the device. If no solution is detected, the device returns to sleep mode. If a solution is detected, the device quickly flashes a yellow LED light in step 723. For example, the device LED may blink twice per second. The rapid flashing may indicate that the device is determining whether the cleaning fluid and system are functioning properly. In step 724, the device delays for 5 to 15 seconds before taking the baseline temperature measurement to allow the temperatures of the cleaning solution, vial, and end cap to equilibrate. In step 725, after equilibration, initial solution and atmospheric temperature measurements are taken. The solution temperature serves as a reference point where future solution temperature rates can be determined. It is useful to make atmospheric temperature measurements as the cleaning fluid can be heated by exothermic chemical reactions or heat from the environment. Once the air temperature is known, atmospheric heating that can break down the solution gives a more accurate chemical heating measurement. In step 726, the device routinely checks whether the end cap is continuously immersed in the solution.

If no solution is detected in step 726, the LED flashes red in step 730, indicating an interruption in the cleaning process and that the contact lens cannot be safely placed in the eye. The red flashing LED continues to flash for 30 seconds and then returns to the low power sleep mode at the beginning of the sequence. If a solution is detected, the microcontroller delays for 30 seconds in step 727. In step 728, the solution and atmospheric temperature measurements are resampled or performed. In step 729, the device routinely checks whether the end cap is continuously immersed in the solution, and the process continues with the checking of the solution. In step 732, the theoretical temperature rate is calculated from a calibration of the solution temperature measurement and the atmospheric temperature measurement. In step 733, if the actual temperature rate is not within 20% of the calculated theoretical temperature rate, then in step 741 the LED flashes red to indicate that the lens cannot be safely inserted into the eye. After 30 seconds, the device may continue to wait until no solution can be detected in step 742, and then the process returns to the beginning in step 743.

In step 733, if the actual temperature rate is within 20% of the calculated theoretical temperature rate, then in step 734 the apparatus slowly flashes a yellow LED light, for example, once every 2 to 3 seconds. The purpose of the slow flashing is to indicate that the device has determined that the cleaning solution and system are functioning properly and that the device is cleaning a contact lens. In step 735, the device detects whether the end cap is continuously immersed in the solution. In step 736, if solution is detected, the device allows the rinse solution to continue for 6 hours to complete the cleaning/neutralization cycle. If 6 hours have elapsed, then in step 737 the device slowly flashes a green LED light to indicate to the user that the device has completed a cleaning/neutralization cycle and that the contact lens can be safely inserted into the eye. In step 738, the device continues to flash the green LED light until no solution is detected, and in step 743, returns to the beginning. If the solution continues to be detected in step 738 and 7 days have elapsed in step 739, the LED flashes a red light in step 740 indicating that the contact lens cannot be safely inserted into the eye. This is due to the possibility of the microorganisms re-infecting the sterile solution. The red LED light will continue to flash until no solution can be detected in step 744.

FIG. 17 shows an embodiment of a system 600 that includes a cleaning cartridge 610 and an outer cartridge 680, where the pressure in the headspace above the cleaning fluid is measured within the cleaning cartridge and a message is displayed on the outer cartridge according to the pressure profile. Cleaning cartridge 610 includes end cap 630 and may also include the aforementioned components not shown here, such as a basket holding a contact lens, catalyst, etc. In this embodiment, end cap 630 includes cartridge contacts 650A and 650B. Also shown is sleeve 680, which includes the structure described above, such as sleeve housing 151, indicator lights 152A and 152B, and display panel 154. Outer box contacts 670A and 670B are also shown.

Still referring to fig. 17, when the cartridge is placed in the sleeve 680, the cartridge contacts 650A and 650B are in electrical contact with sleeve contacts 670A and 670B. In this way, there is an electrical connection between the cartridge and the outer casing to enable other configurations of the system. The cleaning cartridge 610 also includes a cylinder 620 having an orientation component that, once placed in the outer casing, brings the cartridge contacts 650A and 650B into good contact with the outer casing contacts 670A and 670B, even if the cleaning cartridge is rotationally positioned. Such orientation members may be fins, such as the illustrated fins 621, or may be grooves, lugs, dimples, or similar structures. In this case, the sleeve also includes a corresponding receptacle, not shown, which can receive or cooperate with a structure on the barrel. Such receivers may be grooves, tabs, dimples or recesses and are not shown in the figures. For example, sleeve 680 may include a groove for receiving tab 621 when box 610 is placed in the sleeve. Other mechanisms for properly orienting the cartridge in the outer box can be readily envisioned.

Referring to fig. 18A, certain components and additional structure of the cleaning cartridge embodiment shown in fig. 17 are shown. Fig. 18A illustrates a side view of the end cap 630 of the cleaning cartridge illustrated in fig. 17.

As described above, when the peroxide-based cleaning liquid and the catalyst are used, an oxidation-reduction reaction occurs. During this reaction, oxygen bubbles are generated at the catalyst. These bubbles float to the surface of the solution, releasing oxygen thereon. If the end cap forms a suitable gas-tight seal on the cylinder, the pressure in the headspace above the solution increases with the release of gas. Fresh solution and catalyst will generate more gas than old. Messages regarding the quality and useful life of the cleaning solution and catalyst may be communicated to the user using these concepts.

Still referring to fig. 18A, end cap 630 includes a number of components that can measure the pressure of the gas generated by the reaction of peroxide with the catalyst, i.e., a reaction sensor in the form of a pressure sensor. Internal port 632 allows gas to enter bladder 633 from headspace 631, where it pushes against diaphragm 634. As pressure builds, diaphragm 634 pushes against shorting bar 636, which is disposed against spring 638 toward end cap top 643 until it contacts pins 646A and 646B. Pins 646A and 646B are connected to lines 640A and 640B, respectively, which are connected to cartridge contacts 650A and 650B, respectively.

After the cleaning cycle begins and the cartridge 610 is placed within the outer casing 680 (fig. 17), gases are generated by a chemical reaction. When the electrically conductive shorting bar 636 contacts pins 646A-B, an electrical connection is made between the two pins and the connection to the logic chip is completed. Thus, a signal may be sent to the processing device to cause a message to be displayed and/or a timer to also begin displaying the message at a later time. For example, a message such as "your contact lens is cleaning" may be displayed in, for example, display 154 when shorting bar 636 is connected to pins 646A and 646B (FIG. 17). At this point, the timer may count to a particular time, such as 6 hours, at which time a message such as "your contact lens is clean and ready" may be displayed. Alternative alternatives can be readily envisaged.

Referring again to fig. 18A, external port 642 allows gas to escape with diaphragm 634 and shorting bar 636 is disposed toward end cap tip 643. End cap 630 may also include an overflow port 644 opened by an overflow valve 648. In some cases, such systems may allow excess gas to escape from the headspace when the pressure in the headspace exceeds a certain amount.

Fig. 18B shows a top view of the endcap shown in fig. 18A. This view shows shorting bar 636, spring 638, external port 642, overflow port 644, pins 646A-B, and cartridge contacts 650A-B. In the embodiment shown in fig. 18A-B, the shorting bar 636 is shown as a disk, however, may take any other suitable shape, such as a pin or bar, oval, etc.

The above examples specifically describe an embodiment in which the temperature of the solution is measured using a temperature sensor, and another embodiment in which the pressure of the gas generated by the reaction of the peroxide with the catalyst is measured by a pressure sensor. However, the present disclosure encompasses additional embodiments in which other ways of measuring or sensing a property using a sensor may be used. Such sensors may be, for example but not limited to, electronic sensors (which include a sensor of electrical conductivity, voltage or other electronic properties, such as between two electrodes), acoustic sensors, optical sensors or gas sensors. For example, in one embodiment, the cartridge may include two electrodes (the catalyst may be one electrode) that contact the cleaning solution. As the peroxide and catalyst reaction proceeds, the difference in conductivity or voltage over time can be measured using the reaction sensor and used to start a timer or display one or more messages, as described above. In other embodiments, other types of sensors may be used to drive similar processes.

Also provided is a method of monitoring patient compliance with a protocol for cleaning a medical device with a cleaning solution, the method comprising obtaining data by measuring a property of the cleaning solution or a nearby area or the medical device, and displaying one or more messages based on the data. Data obtained from the measurements ("measurement data") may be compared to predetermined data stored in memory, and the one or more messages may be based on the comparison between the measurement data and the predetermined data. In some embodiments, the data may be provided to a medical professional. For example, in one approach, data from measuring the temperature or temperature profile of the cleaning cartridge may be obtained and compared to predetermined data, such as an acceptable temperature profile range (see discussion of FIG. 5 above). If the measurement data is within an acceptable range, a message such as "disinfect Normal work" may be displayed; otherwise a message such as "disinfection not successful" may be displayed. Data for a series of cleaning events may be stored over time. This data may be provided to the user or medical health professional ((e.g., in embodiments where the medical device is a contact lens, the optician or assessed thereby. for example, the user or medical professional may assess the data using a computer, smartphone, or similar computing device. the data may provide a history of the user's cleaning status over some time, such as six months or a year).

Any of the apparatuses or systems (e.g., enclosures) or methods described herein have the following additional structures or components. They may include a first sensor and a second sensor, wherein the first and second sensors are each of the sensors described above (thermal, optical, etc.), and wherein the first sensor measures a property related to the oxidation/reduction reaction of the peroxide and catalyst (such as a change in temperature, a change in conductivity or voltage between electrodes, pressure, sound, etc.), and the second sensor measures some "signature" of the solution. The indicia may be ((for example)) a unique absorbance that one supplier's wash is not present in the other wash. The sleeve can be programmed to operate only when this "tag" is detected. Thus, the outer box can be manufactured to operate only when a particular supplier's cleaning solution is used. In some embodiments, the apparatus or system may include a selector switch or similar input device wherein the user selects the frequency at which he or she changes contact lenses. For example, the selector switch may include a daily, weekly, biweekly, or monthly change-over option. Such selection may also be made using a computer or similar device that sends a signal to the processing device to display a message advising the user to change his contact lens.

While various exemplary embodiments, aspects and variations are provided herein, those skilled in the art will be able to recognize certain modifications, alterations, additions, and combinations and certain subcombinations of the embodiments, aspects and variations. The following claims are intended to be illustrative, and include all such modifications, alterations, additions, and combinations and certain subcombinations of the embodiments, aspects, and variations are within their scope. Thus, while temperature sensors and pressure sensors are not structural equivalents within the context of this disclosure, as temperature sensors may measure temperature using infrared detectors and pressure sensors may measure pressure of gases, the vicinity of cleaning or one or more medical devices to be cleaned, temperature sensors and pressure sensors may be equivalent structures within the context of measuring properties of cleaning fluids.

Claims (29)

1. A contact lens cleaning system, the system comprising:

a contact lens holder;

a vial adapted to contain the contact lens holder and a cleaning solution;

a reaction sensor adapted to monitor a chemical reaction rate of the cleaning fluid;

a processing device in communication with the reaction sensor to receive a reaction signal from the reaction sensor; and

a display in communication with the processing device, the processing device adapted to operate the display to provide cleaning efficacy information according to the response signal.

2. The system of claim 1, further comprising a catalyst element disposed within the vial and adapted to react with the cleaning solution.

3. The system of claim 1, wherein the reaction sensor is a temperature sensor.

4. The system of claim 3, wherein the temperature sensor is disposed within an end cap covering the vial.

5. The system of claim 3, wherein the temperature sensor is disposed outside of the vial.

6. The system of claim 3, wherein the processing device is adapted to determine a rate of temperature change from the response signal.

7. The system of claim 6, wherein the processing device is further adapted to determine cleaning efficacy by comparing the rate of temperature change to a theoretical rate of temperature change.

8. The system of claim 3, further comprising an ambient temperature sensor disposed outside the vial and adapted to measure the temperature of the air surrounding the vial, the processing device further adapted to display cleaning efficacy information based on a temperature signal from the ambient temperature sensor.

9. The system of claim 1, further comprising a usage counter in communication with the processing device, the processing device further adapted to display information corresponding to a number of cleaning uses of the cleaning system.

10. The system of claim 1, wherein the reaction sensor is a pressure sensor.

11. The system of claim 1, further comprising an outer box adapted to carry the vial.

12. The system of claim 11, wherein the display is disposed within the enclosure.

13. The system of claim 1, wherein the display is disposed within an end cap on the vial.

14. The system of claim 1, further comprising a solution sensor disposed within the vial, the processing device further adapted to determine the presence of a cleaning solution within the vial based on a signal from the solution sensor.

15. The system of claim 14, wherein the solution sensor comprises an electrode.

16. The system of claim 14, wherein the solution sensor comprises a capacitive sensor.

17. A method of cleaning a contact lens and displaying cleaning efficacy information, the method comprising:

receiving a contact lens in a contact lens holder;

receiving a cleaning solution in a vial containing the contact lens and contact lens holder;

determining a chemical reaction rate of the cleaning fluid and cleaning efficacy information according to the chemical reaction rate; and

displaying the cleaning efficacy information.

18. The method of claim 17, wherein the vial further comprises a catalyst, the chemical reaction rate comprising a chemical reaction rate between the cleaning solution and the catalyst.

19. The method of claim 17, wherein the determining step comprises monitoring temperature.

20. The method of claim 19, wherein the determining step comprises monitoring a temperature of the cleaning fluid.

21. The method of claim 19, wherein the determining step comprises monitoring a temperature outside the vial.

22. The method of claim 19, wherein the determining step comprises calculating a rate of temperature change.

23. The method of claim 22, wherein the determining step further comprises comparing the rate of temperature change to a theoretical rate of temperature change.

24. The method of claim 19, wherein the determining step comprises monitoring a temperature within the vial.

25. The method of claim 24, further comprising monitoring an ambient temperature outside the vial, the determining step comprising determining the chemical reaction rate from the temperature inside the vial and the ambient temperature.

26. The method of claim 17, further comprising counting the number of cleaning uses of the contact lens.

27. The method of claim 26, further comprising displaying information relating to the number of contact lens cleaning uses.

28. The method of claim 17, wherein the determining step comprises monitoring pressure within the vial.

29. The method of claim 17, further comprising determining whether a cleaning fluid is present in the vial prior to the step of determining a chemical reaction rate.