Delivery of substances to animals

Abstract

A method of delivering a substance to an animal includes using a controller to topically deliver an initial dose of the substance to the skin of the animal, followed by one or more administrations of the substance to the skin of the animal, wherein the initial dose includes multiple sub-initial doses delivered at discrete time intervals separated from one another by time gaps, during which no administrations are delivered, and wherein the total amount of the sub-initial doses equals the initial dose.

Description

[Technical Field]

[0001] The present invention relates generally to methods for the delivery of substances, such as drugs and pharmaceuticals, to animals, and more particularly to methods and protocols for the delivery of substances to the hair, fur or skin of animals. [Background technology]

[0002] A drug delivery device for delivering a substance to a pet is described in PCT patent application WO2014 / 028427. The delivery device has an actuation chamber containing an actuation substance sealed by a chamber membrane. Summary of the Invention

[0003] The present invention seeks to provide an improved, controllable drug delivery device, which may or may not be wearable on an animal or the like, as described in more detail below. The delivery device is for delivering substances such as, but not limited to, drugs, pharmaceuticals, pheromones, fragrances, deodorants, etc. It should be noted that the terms "substance" and "drug" are used interchangeably throughout and include not only drugs, pharmaceuticals, pheromones, fragrances, or deodorants, but also any chemical used to produce a desired result. The delivery devices of the present invention may be of any size and shape.

[0004] Some of the substances that can be delivered by the delivery device include anti-flea compounds, anti-mite compounds, anti-parasitic compounds, anti-fungal compounds, anti-bacterial compounds, anti-viral compounds, sedatives, analgesics, and other pain relievers, as well as others in the form of liquids, gels, ointments, and other flowable substances, referred to herein as fluids. The substances may be topical / external / treatment, topical use / treatment, or systemic use / treatment, or topical and systemic treatment. For example, formulations may include, but are not limited to, topical chemical actives such as fipronil, permethrin, and imidacloprid to treat (e.g., kill and / or repel) fleas, ticks, mosquitoes, flies, and other external ectoparasites. The substances may include, but are not limited to, transdermal systemic actives such as moxidectin and selamectin, which enter the body through the skin to treat endoparasites such as earthworms, hookworms, and roundworms.

[0005] The delivery device of the present invention includes a controller for controlling drug delivery according to different protocols, as described in more detail below.

[0006] Thus, according to non-limiting embodiments of the present invention, there is provided a method of delivering a substance to an animal, the method comprising using a controller to locally deliver an initial dose of a substance to the skin (or fur / hair) of the animal, followed by one or more administrations of the substance to the skin of the animal, wherein the initial dose comprises a plurality of sub-initial doses delivered at discrete time intervals separated from one another by time gaps, during which no administrations are delivered, and wherein the total amount of the sub-initial doses is equal to the initial dose.

[0007] According to non-limiting embodiments of the present invention, the agent is a pest control agent, and the initial dose provides a concentration of the active agent on the skin (or fur / hair) that exceeds a first active agent concentration threshold level necessary to achieve an efficacy level for killing pests that infested the animal prior to administration of the initial dose, and one or more subsequent doses are sufficient to maintain a concentration of the active agent on the skin (or fur / hair) that exceeds a second active agent concentration threshold level, which may or may not be less than the first active agent concentration threshold level, to achieve an efficacy level for killing or preventing or preventing / repelling re-infection of the animal during the treatment period.

[0008] According to a non-limiting embodiment of the present invention, one or more subsequent doses are less than the initial dose.

[0009] According to a non-limiting embodiment of the present invention, the initial dose is zero.

[0010] According to a non-limiting embodiment of the present invention, the method includes varying the dosage of the substance using a controller.

[0011] According to a non-limiting embodiment of the present invention, the administration of a substance is modified to take into account environmental factors.

[0012] According to a non-limiting embodiment of the present invention, the administration of the substance is altered to account for climate change, temperature changes, or humidity changes.

[0013] According to a non-limiting embodiment of the present invention, the administration of the substance is modified taking into account the immunity level of the pest / parasite.

[0014] According to a non-limiting embodiment of the present invention, administration of the substance is modified to take into account the presence of allergens, irritants, or pests.

[0015] According to a non-limiting embodiment of the present invention, the method includes using a controller to vary the time interval between administrations of the substance.

[0016] According to a non-limiting embodiment of the present invention, the method includes using a controller to vary the duration of administration of the substance.

[0017] According to a non-limiting embodiment of the present invention, the method includes using a controller to vary the dosage of the substance.

[0018] According to a non-limiting embodiment of the present invention, the method includes using a controller to select between different administration protocols, wherein an initial dose of the administration protocol is selected from zero to an amount greater than zero, and one or more subsequent doses are selected from zero to an amount greater than zero.

[0019] According to a non-limiting embodiment of the present invention, the choice of one administration protocol is made by the veterinarian or animal owner.

[0020] According to a non-limiting embodiment of the present invention, selection of one of the administration protocols is performed through an application using a communications link (such as, but not limited to, a smartphone, personal communications device, computer, etc.).

[0021] According to non-limiting embodiments of the present invention, the selection of one of the administration protocols or the setting of specific administration parameters is made taking into consideration at least one of the following parameters from the database: the specific animal breed, the animal's weight, hair length, the time the animal spends indoors or outdoors, usage history, seasonality, season, geography, the animal's immune level, adverse or allergic reactions to the substance, climate, temperature, humidity, anxiety factors, and behavioral data.

[0022] According to non-limiting embodiments of the present invention, the method includes using a controller to synergistically combine local administration of a substance with a health device, which may be a separate device or a health function integrated into the device. Data collection, analysis, and calculation of administration instructions can be performed using cloud servers, big data, and communication links without limitation.

[0023] According to a non-limiting embodiment of the present invention, the substance comprises a combination of different substances.

[0024] According to a non-limiting embodiment of the present invention, the local delivery of the substance further induces systemic changes in the animal.

[0025] According to a non-limiting embodiment of the present invention, a method of delivering a substance to an animal is provided, the method comprising the steps of delivering a substance to the skin or fur / hair of the animal using a controller, sensing a parameter associated with the substance or the animal, and using feedback from the sensor to control further delivery of the substance to the skin of the animal.

[0026] The present invention seeks to provide an improved, controlled drug delivery device that combines drug delivery to pets with pet health, as described in more detail below. The delivery device is for delivering substances such as, but not limited to, drugs, pharmaceuticals, fragrances, pheromones, and deodorizers. It should be noted that the terms "substance" and "drug" are used interchangeably throughout, and these terms encompass not only drugs, pharmaceuticals, fragrances, or deodorizers, but also any chemical used to produce a desired result. The delivery device of the present invention may be of any size and shape.

[0027] Some of the substances that can be delivered by the delivery device include, but are not limited to, anti-flea compounds, anti-tick compounds, anti-parasitic compounds, anti-fungal compounds, anti-bacterial compounds, anti-viral compounds, sedatives, pain relievers and other pain relievers, pest or parasite deterrents / repellents or control agents, and others in the form of liquids, gels, ointments, and other flowable substances, referred to herein as fluids. The present invention is applicable to any animal, including, but not limited to, farm animals such as dogs, cats, horses, cows, sheep, goats, or other pets or animals. Alternatively, some embodiments are applicable to humans.

[0028] According to a non-limiting embodiment of the present invention, a method of caring for an animal is provided, the method comprising using a health controller to compare a health parameter of the animal to a known value of the health parameter, and using a delivery controller to control drug delivery to the animal, the delivery controller including the health controller or distinct from said health controller.

[0029] The method uses a health controller or a delivery controller to control drug delivery to the animal as a function of the comparison. The known value of the health parameter can be a parameter within a range defined in a health protocol as a normal range, or a previously measured parameter, or can be derived from learning or studying the animal's previous behavior or previous health parameters, or is a previously stored parameter.

[0030] The health controller or delivery controller provides information about the animal's drug delivery or health to a user and / or veterinarian. The health controller or delivery controller can receive information about drug delivery and the animal's health and can modify drug delivery or animal health parameters accordingly. Drug delivery includes local drug delivery to the animal's skin, fur, or coat, and health is the local or systemic health of the animal. Drug delivery includes a timed sequence of administration, at least one bolus, or a combination thereof. Drug delivery includes delivery of different drugs or two or more separate drugs administered independently. Drug delivery includes delivering drugs via an article worn by the animal, such as a collar, harness, bracelet, or other means.

[0031] The health controller or delivery controller receives information from the drug delivery sensor and the health sensor. The health sensor includes a movement sensor that senses movement of the animal. The health sensor includes multiple movement sensors, each of which senses movement of a different part of the animal, and the health controller or delivery controller interprets the movement as a parameter of the animal's health. The health sensor includes a temperature sensor that senses the animal's body temperature or ambient temperature, or a pulse sensor that senses the animal's pulse, or a chemical sensor that senses at least one of respiration, sweat, exudates, tears, hormone secretions, and saliva, or an optical sensor, or an accelerometer.

[0032] The health or delivery controller modifies the delivery of the drug taking into account environmental factors, climate change, changes in ambient temperature or humidity, immunity levels of parasites, or the presence of allergens, irritants or pests.

[0033] The health controller or delivery controller may vary the time interval between administrations of the drug, or the duration of administration of the drug, or the dosage of the drug.

[0034] The health controller or delivery controller can be used to select between different administration protocols, where an initial bolus amount of the administration protocol is selected from zero to greater than zero, and one or more subsequent administrations are selected from zero to greater than zero. The selection can be made by a veterinarian or the animal owner, or through an application using a communications link. The selection of one of the administration protocols is made taking into account at least one of the following parameters: a database, the particular animal's breed, the animal's weight, hair length, the amount of time the animal spends indoors or outdoors, usage history, seasonality, time of year, geography, parasite immunity level, adverse or allergic reactions to the substance, climate, temperature, humidity, anxiety factors, and behavioral data.

[0035] According to non-limiting embodiments of the present invention, an animal care apparatus is provided, the animal care apparatus including a health controller configured to compare a health parameter of the animal with a known value of the health parameter, and a delivery controller configured to control drug delivery to the animal, where the delivery controller includes the health controller or is distinct from the health controller. A computer-implemented method for caring for an animal includes providing an application to an interface device, such as a smartphone or other device, having a computer processor and memory storing computer code, the application related to the animal's health parameters and drug delivery to the animal. The animal care apparatus includes an interface device having a computer processor and memory storing computer code for executing the application related to the animal's health parameters and drug delivery to the animal. [Brief explanation of the drawings]

[0036] The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the drawings in which:

[0037] [Figure 1A-B]1A and 1B are simplified graphical illustrations of initial administration and resulting concentrations of active ingredients on the skin of an animal, respectively, according to non-limiting embodiments of the present invention. [Figure 2A-B] 2A and 2B are simplified graphical illustrations of continuous microdosing and the resulting concentration of an active ingredient on an animal's skin, respectively, according to a non-limiting embodiment of the present invention. [Figure 3A-B] 3A and 3B are simplified graphical illustrations of treatments (including initial dosing and continuous microdosing) and resulting concentrations of active ingredients on the skin of animals, respectively, according to non-limiting embodiments of the present invention. [Figure 3C-D] 3C and 3D are simplified graphical illustrations of treatments (including initial administration and continuous microdosing) and resulting concentrations of active ingredients on the skin of an animal, respectively, according to another non-limiting embodiment of the present invention. [Figure 4] FIG. 4 is a simplified graphical representation of microdosing of a substance, such as, but not limited to, 20 microdoses of 13.4 μl spaced one minute apart, in accordance with a non-limiting embodiment of the present invention. [Figure 5] FIG. 5 is a simplified block diagram of a substance delivery and wellness system and method for animals, constructed and operative in accordance with a non-limiting embodiment of the present invention. [Figure 6A-B] 6A and 6B are simplified diagrams of an apparatus for substance delivery and wellness for animals, constructed and operative in accordance with a non-limiting embodiment of the present invention. [Figure 6C] FIG. 6C is a simplified block diagram of the components of the device of FIGS. 6A and 6B. DETAILED DESCRIPTION OF THE INVENTION

[0038] Thus, the present invention provides controlled administration during treatment. The substance is delivered to the skin / hair / fur of the animal (the term "skin" is used throughout this specification to encompass skin, hair, fur, etc.). The substance, or at least the active ingredient of the substance, spreads to the skin or other parts of the body, such as by, but not limited to, diffusion.

[0039] In contrast to other delivery methods, such as injection or ingestion, one of the challenges of administering topical substances to an animal's skin is that the topical substance must be dispersed or diffused over the skin. If the substance does not disperse properly, pools of the substance can accumulate in one spot or zone on the skin. This creates a localized concentration of the substance, which has many drawbacks. First, it can cause a local overdose of the substance, which can be harmful (e.g., skin irritation or burns). Second, the localized concentration of the substance is not delivered properly at the required rate, significantly reducing its effectiveness. Third, a greasy spot can form, which can transfer some of the substance to the person petting the animal or the animal's surroundings, potentially contaminating them. Fourth, because the substance is concentrated locally, there is a risk of spillage of the substance into the surrounding area, such as on a collar, device (discussed in more detail below), or backflow onto the person petting the animal, resulting in an insufficient amount of the substance being distributed and dispersed over the animal's skin.

[0040] There are many situations where a higher initial dose of substance needs to be delivered at the beginning of treatment to address the initial infestation, such as when an animal is already infected with a pest before treatment begins. As parasites (fleas, ticks, etc.) grow and gain strength, and populations become abundant on animals, it becomes more difficult to treat or eliminate the pre-treatment infestation. Localized delivery of a one-time bolus can create the aforementioned pooling effect, with all its drawbacks. The present invention provides a solution to this problem.

[0041] The initial administration (e.g., a bolus administration) may not be a single, large dose. Instead, it may be a series of individual doses that avoid pooling problems and allow for improved or optimal diffusion of the topical substance to the animal's skin. Note that a topical formulation may also be a systemic formulation that enters the animal's body through the skin (for the treatment of internal parasites or other systemic treatments, such as analgesia). Alternatively, the initial administration may be a single large dose, or may be administered continuously over a predetermined period lasting a few seconds, minutes, hours, or days, or as a series of successive smaller doses or pulses of administration.

[0042] Non-limiting examples of substance delivery protocols are shown in Figures 1A, 1B, 2A, 2B, 3A and 3B. An example of initial administration is shown in Figure 4.

[0043] The illustrated examples include administration of a relatively large initial dose (FIGS. 1A and 1B) or successively lower doses of substance over the course of ongoing treatment (FIGS. 2A and 2B).

[0044] For example, in Figure 1A, instead of a single bolus, an initial dose of 20 microdoses of 13.4 μl is delivered at 1-minute intervals over a 20-minute period. As seen in Figure 1B, this results in a concentration of the active ingredient on the animal's skin that is initially very high and then decreases rapidly asymptotically over time.

[0045] The protocols of Figures 1A and 1B may not be effective long term, but are intended to be effective in treating pre-treatment infections.

[0046] In contrast to the example of Figures 1A and 1B, the example of Figures 2A and 2B shows a continuous treatment plan. In this non-limiting example, 1.34 ml of an anti-flea and tick topical / spot formulation containing fipronil and s-methoprene (commonly used for manual administration / treatment of medium-sized dogs for a one-month anti-flea and tick treatment) is administered in small doses over an extended treatment period.

[0047] In one example of the present invention, a daily dose of 13.4 μl (1% of the recommended manual monthly dose) is automatically administered daily by the device. The fipronil concentrations on the animal's skin resulting from this treatment are shown in Figure 2B. As can be seen, within approximately 20 days, the concentrations converge to a steady-state concentration level and remain at this level as long as daily microdosing treatment continues. While such a protocol is effective in the long term, it may not treat pre-treatment infections.

[0048] FIG. 3A shows another treatment involving an initial dose and continuous microdoses, and FIG. 3B shows the resulting concentrations on the skin of animals treated with this treatment.

[0049] For example, if the individual doses = 1% of the total recommended monthly dose (usually administered manually once a month) = 13.4 μl, then instead of 20% of the initial dose, 20 1% doses can be administered. As shown in Figure 4, there is little time between them, such as 1 minute between doses. This corresponds to a single initial dose of 20 x 13.4 μl = 268 μl. Subsequently, as shown in Figures 2A and 3A, successive daily doses of 13.4 μl are administered throughout the treatment period (e.g., 10 days, 30 days, 100 days, 1 year, or other period). Dividing the initial dose into 20 doses avoids pooling issues and is highly effective for treating early infections.

[0050] The amount of material in the initial administration is defined to achieve a high concentration of active ingredient on the animal's skin that exceeds a first concentration threshold level (Level 1, as seen in FIG. 3B ), which is the concentration level required to achieve early kill of the pre-treatment infection, i.e., to achieve efficacy against the pre-treatment infection (without limitation, initial kill can be achieved within 4, 12, 24, 48, 72, or 96 hours, depending on the amount of formulation administered in the initial administration). However, according to one embodiment of the present invention, the initial administration is still much less, such as, but not limited to, only about 20% of the monthly recommended dosage in the manual. That is, the initial administration only treats the pre-treatment infection, killing or eliminating only pests already present on the animal. In other words, the initial administration is not intended to treat or repel infection later during treatment, but only at the beginning of treatment.

[0051] The amount of material in the continued treatment is prescribed to achieve a concentration of the active ingredient on the animal's skin that exceeds a second concentration threshold level (Level 2 as seen in Figure 3B), which is the concentration level required to treat or repel subsequent infections already during treatment, i.e., to achieve efficacy against continued infection. The second efficacy level for continued killing or repelling will typically be significantly lower than the first efficacy level for treating the pre-treatment infection.

[0052] It is noted that the substance is delivered in a particular dosage containing a particular level of active ingredient or active ingredients (referred to in the singular as active ingredient), which level of active ingredient provides a level of effectiveness for treating (preventing, killing, repelling, etc.) pests. Thus, a first amount of active ingredient provides a first level of efficacy, a second amount of active ingredient provides a second level of efficacy, and so on.

[0053] Figure 3C shows an automated microdosing treatment protocol, including an initial dose and continuous microdosing, compared to a monthly manual spot-on treatment. Figure 3D shows a comparison of the concentrations on the animal's skin obtained for the two treatments. In Figure 3C, the microdosing protocol includes a 1 / 5 sub-dose on the first day (compared to the manual monthly dose) followed by 1 / 100 daily sub-doses. The sub-doses are fipronil and s-methoprene formulations and are compared to commercially available monthly manual dosing. Figure 3D compares the amount of insecticide on the skin / fur of a pet administered according to one embodiment of the present invention, as opposed to manual spot-on administration. While the efficacy of the present invention is clearly superior to manual administration, exposure to toxic substances is significantly lower and therefore much safer.

[0054] Thus, the protocols of the present invention initially achieve an initial kill or repulsion (for example, but not limited to, using only about 20% of the recommended monthly manual dosing), and then continue continuous treatment with, but not limited to, only 1% (or less) of the average daily dosing, sufficient to treat or repel new infections during treatment. Treatment can continue indefinitely (without degradation) as long as continuous microdosing treatment continues.

[0055] Thus, the present invention dramatically reduces the amount of drug used and reduces unnecessary exposure to chemicals while achieving consistent treatment over the long term as the microdosing treatment protocol is continued. Generally, the controller may control the time interval between doses, the duration of doses, or the average dose rate to provide consistently equal doses (delivered by a given drug delivery amount).

[0056] If the half-life of the drug is significantly longer than the time interval between individual doses, these individual doses will maintain a stable dosage level in the animal's skin / hair / fur. There may be slight variations in the concentration level of the active ingredient between individual doses, but these will be relatively small and will not impair the effectiveness of the treatment.

[0057] By controlling the average administration rate, the amount or concentration of the active drug on the animal's skin / coat / fur can be controlled. Increasing the average administration rate by shortening the time interval between individual administrations increases the amount or concentration of the active drug on the animal's skin / hair / fur.

[0058] As noted above, higher levels or concentrations of a substance are required on or in an animal to treat a pre-treatment infection. This is called the initial kill threshold level. An amount of a substance that exceeds the initial kill threshold level for a sufficient period of time achieves the required initial kill effect.

[0059] Once the pre-treatment infection is eliminated, a lower level or concentration of the substance is sufficient to maintain a clean animal and to treat, treat, or repel new infections. This level is called the persistent or continuous killing threshold level.

[0060] As noted above, the first efficacy level (Level 1) is the concentration of active ingredient needed to treat the initial infection, and the second efficacy level (Level 2) is typically a lower concentration than the first efficacy level that is needed to control or prevent further infection after eradication or reduction of the effects of the initial infection.

[0061] Thus, the administration protocol in one aspect of the present invention achieves an early killing effect to treat the initial infection and a long-term sustained killing or repellent effect, while minimizing exposure to toxic substances and minimizing the substance or total amount of substance required.

[0062] The delivery device of the present invention includes a controller for controlling drug delivery, which follows different protocols in combination with the health of the animal. The controller integrates drug delivery to the animal with the animal's well-being.

[0063] In the prior art, drug delivery systems are separate from animal health systems. In the prior art, detection of health parameters typically involves a period of observation by the animal's owner or veterinarian. Only after the observation is made are decisions regarding drug delivery made.

[0064] In contrast, in the present invention, drug delivery is controlled and monitored throughout the entire treatment period, and the animal's health status is also monitored. Drug delivery and animal health are presented to the user and / or veterinarian in an integrated system. In some cases, control of drug delivery is related to the animal's health or specific indicators of the animal's health. This results in a synergistic effect between health and drug delivery, but the amount of drug delivered can be adjusted in response to specific conditions and is significantly reduced because the drug is administered before health issues worsen. Furthermore, because the animal is treated with the drug immediately, the animal's health and well-being are maintained, leading to improved health status and reduced medical costs.

[0065] The controller (including multiple controllers operating in coordination) can communicate via any communication link, smartphone application (app), etc. The one or more devices for drug delivery and health condition sensing may be a single unit or multiple units, e.g., with some reusable and some disposable. The one or more devices may all be on the animal, one or more may be on the animal and one or more may not be on the animal, or one or more may not all be on the animal, and may use inter-device communication (wired or wireless) or alternatively may not require inter-device communication.

[0066] An overall block diagram of the system is shown in Figure 5. The controller may communicate (wired or wirelessly) with databases, users, veterinarians, hospitals, animal owners, drug suppliers, etc. The controller may communicate with any type of health sensor, such as, but not limited to, an animal temperature sensor, an ambient temperature sensor, a humidity sensor, an animal pulse sensor, an animal respiration sensor, a microphone, an animal movement or activity sensor (e.g., an accelerometer, etc.), a location sensor (e.g., a GPS, etc.), an animal oxygen saturation sensor, or other additional sensors.

[0067] Health in the prior art is very often subjective, with the pet owner or veterinarian determining the animal's health status by looking at the animal, without taking temperature or blood tests, or providing feedback on the results of taking some action (such as administering pain medication). In the present invention, health is made more objective and measurable, removing the guesswork from the subjective opinions of the prior art. In the present invention, health is a comparison of a health parameter or parameters (such as the animal's temperature, ambient temperature, humidity, the animal's pulse, the animal's breathing, the animal's sounds, the animal's movement or activity, geographic location, weather conditions, the animal's oxygen saturation, and many others) with a known health parameter or parameters. For example, known health parameters are stored in a database and include what is considered to be an animal's normal temperature range or normal ranges for other parameters, such as normal head movement, leg movement, etc.

[0068] As another example, the known health parameters may be parameters previously measured for the animal. In this manner, the animal's health is a function of the current health parameters compared to previous health parameters previously measured for the animal (e.g., but not limited to, seconds, minutes, hours, days, weeks, months, etc.). The animal's health can be assessed and learned over time based on changes in the health parameters measured over time. Even small changes over time can be important indicators of a particular animal's health. For example, a consistent decline in an animal's activity level over time correlated with other indicators, such as asymmetrical gait, may indicate pain caused by a medical problem in the joint or specific joint. Such health indicators can help veterinarians prescribe medications for animals and determine recommended dosages. Additionally or alternatively, such health indicators may be used as feedback for automated closed-loop administration of medications.

[0069] As another example, the known health parameters may be parameters previously measured or previously defined as normal ranges for animals of similar age, weight, breed, and other characteristics, in which case the health of the animal is a function of the current health parameters compared to parameters previously measured or previously defined as normal ranges for animals of similar age, weight, breed, and other characteristics.

[0070] The controller compares the sensed health parameter with a normal range for the parameter. The controller can control drug delivery based on this comparison. Alternatively, the controller can control drug delivery and then compare the sensed health parameter with a normal range for the parameter after drug activation, and then further control drug delivery based on this comparison. The comparison, analysis, and decision-making can also be performed or assisted by a remote portion of the system or user, such as an animal owner's smartphone, a veterinary computer, a cloud server, or other system.

[0071] A non-limiting example of integrating drug delivery and health includes controlling the amount of repellent (spot-on or otherwise) administered depending on the drug delivery protocol and anti-parasite and animal behavior (indoor vs. outdoor, animal scratching rate indicating the presence of parasites such as fleas, irritability, and other pet health indicators).

[0072] The system detects pulling or other behaviors by detecting short, rapid, and increasing amplitude (e.g., at a frequency of several cycles per second) series of movements or accelerations that are easily distinguishable from other animal movements such as running, walking, and breathing.

[0073] It should be noted that monitoring / sensing scratching or other behavior provides instructions and feedback to the system of the present invention, allowing the system to modify the dosage in accordance with such feedback. Furthermore, these instructions and feedback can be used to indicate and alert the end of treatment (or advance warning that treatment is about to end within a certain time), a system malfunction, or other alert to the user / veterinarian. It should be noted that, independent of these specific instructions and feedback, the system can indicate and alert the end or completion of treatment (or advance warning that treatment is about to end within a certain time), a system malfunction, or other alert to the user / veterinarian.

[0074] Another non-limiting example of integrating drug delivery and health includes selecting treatment protocols and / or amounts of antiparasitic and repellent substances depending on environmental conditions (such as, but not limited to, ambient temperature, humidity, time and season, geographic area / location, time of day, etc.) and providing drug delivery and / or health information.

[0075] In addition to sensors within the device providing instructions regarding a specific animal, relevant information is provided via a communications link from a database (provided by a cloud server) to further support / improve treatment / substance administration. For example, the system provides relevant geographically relevant information such as, but not limited to, the presence and expected level of activity of parasites in a particular region and in a particular season, the level of immunity of parasites to formulations used in a particular area (and therefore the need for higher dosages of the formulation), etc.

[0076] Another non-limiting example of integrating drug delivery and health includes controlling the protocol and amount of analgesic medication according to the animal's behavior (level and profile of behavior and animal movement indicative of pain level, or detection of lameness or abnormal behavior as an indicator of pain, or other biological indicators of stress or pain in the animal).

[0077] Another non-limiting example of the integration of drug delivery and health includes the administration of sedatives (such as certain pheromones) to calm animal subjects to detected levels of stress / anxiety / restless behavior / other symptoms.

[0078] Another non-limiting example of drug delivery and health integration includes transmitting drug / substance delivery and health information to a database (e.g., a cloud-based database) and providing a service whereby a medical professional references the database to provide diagnoses, consents, medical test results, etc. to the user or pet owner. In this manner, the system of the present invention provides monitoring, tracking, learning, diagnostic, and reporting services for the animal's health status, while providing clear comparisons of health parameters or indicators over time and alerting or identifying changes relative to previous health parameters, as described above.

[0079] The delivery or administration of medicines, medications, or substances, and the collection, tracking, or analysis of health parameters or information are part of animal healthcare. Integrating these functions into one system unifies the treatment and assessment of an animal's health status, improving overall animal healthcare.

[0080] The availability and immediate access to animal health data compared to normal ranges (e.g., derived from other animals and available via cloud server databases) supports animal owners and veterinary services in providing the best possible care and treatment.

[0081] The integration of drug delivery and health into one system, along with immediate access or availability to an extensive database of knowledge and understanding of animal health, provides a unique synergistic effect to the present invention, as the combined effect of drug delivery and health (including comparison of health indicators over time and an extensive database of animal health knowledge) significantly improves both drug delivery and health. Sensed health indicators are important in assessing and monitoring an animal's health status, as animals cannot readily communicate all types of health indicators to their owners / veterinarians.

[0082] Applicator Description 6A, 6B, and 6C, there is shown a device for delivering a substance to an animal (also called an applicator), constructed and operative in accordance with a non-limiting embodiment of the present invention.

[0083] As seen in, but not limited to, FIG. 6C, applicator 59 includes a controller 60 including one or more batteries 61, a microcontroller 62, and a microactuator 63, and a cartridge 64 (capsule, container, etc.) containing a spot-on formulation reservoir 65 and a microdosing cell 66 designed to dispense a fixed microdose (e.g., measured in microliters) of formulation at a time. Microdosing cell 66 has an inlet and an outlet port. The inlet port is connected to a sealed formulation reservoir 65, and the outlet port is connected to a retractable dosing probe 67. According to a predetermined dosing protocol, a single measured microdose of the formulation is dispensed from the probe onto the animal's skin at a time.

[0084] Figure 6A shows the applicator attached to a pet's collar. The collar with the applicator attached is placed around the animal's neck, and the dosing probe is gently pressed against the animal's skin.

[0085] The probe can be retracted into the device in a variety of ways. For example, the probe may be spring-loaded. As another example, the probe may be retractable or bellows-like so that it collapses into itself when retracted. As another example, the probe may be resilient and flexible (e.g., made from an elastomeric material or a flexible plastic-lined hinge) so that it deforms when pressed into the device. Note that non-retractable probes can present problems when used with a wide variety of fur types. For example, a short, fixed-length probe may be usable on short-haired animals but may be ineffective on long-haired animals, whereas conversely, a long, fixed-length probe may be usable on long-haired animals but may be ineffective on short-haired animals because the probe would move the device away from the animal's skin. The retractability of the probe allows the device to be used on all types of fur.

[0086] Most active ingredients (active ingredients) used in spot-on formulations dissipate over time following a similar pattern (very close, first order exponential decay), so the amount of active ingredient at any given time is expected to follow the following formula: A(t)=A(0)*e- kt where A is the effective dose, either A(t) at any time or A(0) at t=0. k is the decay rate constant of the particular active ingredient. Therefore, the level of the active ingredient at any time depends directly on its dissipation characteristics and the dose administered, A(t=0) = A(0).

[0087] For manual monthly spot-on treatment, to maintain a certain minimum level of active ingredient (e.g., effective level), after, say, 30 days, a relatively high dose needs to be applied on day 0 (as seen in Figures 3C and 3D). This amount increases dramatically with increasing claimed treatment time.

[0088] As a result, pets, their humans, and the environment are repeatedly exposed to high levels of the active ingredient in "overdoses" with each monthly treatment.

[0089] In one aspect of the present invention, a treatment protocol is based on applying microdoses of the formulation at successive intervals throughout a prolonged treatment period (e.g., but not limited to, a 3-month treatment). This protocol maintains a desirable level of the active ingredient on the skin throughout the treatment period while minimizing the total amount of formulation used and completely avoiding "overdose" peaks of high levels of the active ingredient. This protocol balances the requirements of safety and efficacy, allowing for long-term treatment with the topical formulation. The applicator is designed to automatically administer the microdosed formulation according to the treatment protocol, eliminating the need for manual administration of the formulation.

[0090] In one non-limiting application of the present invention, the applicator is designed and programmed to fit four dog weight categories in a manner similar to commercially available spot-on products. Each weight category is assigned an appropriate dosing protocol to maintain a defined average daily dose (ADD) appropriate for that particular weight category. Note that smaller dogs in each weight category will receive a higher average daily dose per kg of dog weight compared to larger dogs in that weight category. Alternatively, the applicator can be configured / programmed to administer an average daily dose calculated and customized for each individual dog's specific weight. Setting the specific animal's weight can be done by the user or authorized personnel, such as a veterinarian, via a smartphone app or other communication means. In this way, every dog, or other animal, is treated with the exact desired / optimized dose.

[0091] Calculated average daily dose (ADD) for a specific dog: TIFF0007743086000001.tif26170

[0092] Calculated average daily dose (ADD) for a specific dog: TIFF0007743086000002.tif17170where (ΔT) is the time difference between two successive individual administrations.

[0093] Therefore, to adjust each applicator to the average daily dose required for each particular dog, the time difference (ΔT) between two successive individual doses is calculated and determined as follows: TIFF0007743086000003.tif21170

Claims

1. 1. An animal care device comprising: a health controller configured to compare a health parameter of the animal with a known value of said health parameter; a delivery controller configured to control drug delivery to the animal based on the comparison by the health controller, the delivery controller including the health controller or distinct from the health controller; the delivery controller is configured to topically deliver an initial dose of a substance greater than zero to the skin of the animal, followed by one or more subsequent doses of the substance greater than zero to the skin of the animal; The initial dose comprises a plurality of sub-initial doses delivered at discrete time intervals separated from one another by time gaps, the total amount of the sub-initial doses being equal to the initial dose.

2. 10. The animal care device of claim 1, the substance is a pest control substance, and the initial dose provides a concentration of one or more active substances on the skin that exceeds a first activity concentration threshold level required to achieve a first efficacy level for initial kill of pests that infested the animal prior to administration of the initial dose, and the initial kill is achieved within 4, 12, 24, 48, 72, or 96 hours.

3. 10. The animal care device of claim 1, the initial dose provides a concentration of one or more active agents on the skin that exceeds a first activity concentration threshold level required to achieve a first efficacy level for killing pests that infested the animal prior to administration of the initial dose; followed by administering one or more subsequent doses of the substance to the animal's skin; wherein the one or more subsequent administrations result in a concentration of one or more active agents on the skin that exceeds a second active concentration threshold level required to achieve a second efficacy level for killing or preventing or preventing re-infection of the animal.

4. 4. The animal care device of claim 3, The apparatus, wherein the second validity level is lower than the first validity level.

5. 10. The animal care device of claim 1, the delivery controller is configured to locally deliver doses of a substance to the skin of the animal at discrete time intervals separated from one another by time gaps; Each of the time gaps is less than the half-life of one or more active substances on the skin, thereby maintaining the concentration of the one or more active substances on the skin above an efficacy threshold throughout the entire treatment period.

6. 10. The animal care device of claim 1, The device, wherein the delivery controller is configured to locally deliver doses of a substance to the animal's skin at discrete time intervals separated from one another by a time gap, and wherein the device does not cause greasy spots or spills or pooling of the substance on the skin.

7. 10. The animal care device of claim 1, wherein said one or more subsequent doses are less than said initial dose.

8. 10. The animal care device of claim 1, wherein the delivery controller is configured to vary the dosage of the substance.

9. 9. The animal care device of claim 8, A device that varies the dosage of the substance taking into account environmental factors, climate change, temperature changes, humidity changes, the animal's immunity level, or the presence of allergens, irritants, or pests.

10. 10. The animal care device of claim 1, The device, wherein the delivery controller is configured to vary the time interval between administrations of the substance, the duration of administration of the substance, or the amount of administration of the substance.

11. 10. The animal care device of claim 1, the delivery controller is configured to select between different administration protocols; The initial dose of the administration protocol is selected from an amount greater than zero, and the one or more subsequent doses are selected from an amount greater than zero.

12. 12. The animal care device of claim 11, The device is characterized in that the selection of one of the administration protocols is made taking into consideration at least one of the parameters consisting of a database, the specific animal breed, the animal's weight, hair length, the time the animal spends indoors or outdoors, usage history, seasonality, season, geography, the animal's immune level, adverse or allergic reactions to the substance, climate, temperature, humidity, anxiety factors, and behavioral data.

13. 10. The animal care device of claim 1, The apparatus, wherein the delivery controller is configured to synergistically combine local administration of the substance in cooperation with a health device.

14. 10. The animal care device of claim 1, The device, wherein the substance comprises a combination of different substances.

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