Veterinary medical device

Abstract

A monitoring device for determination of abnormalities associated with animal mammary glands 5 with a housing 2 to accommodate an animal teat and an agent 3. There is a physiological monitor such as a

Description

Fast and accurate physiological monitoring, diagnostics and prognosis are very important with regard to mammary gland assessments and detection of abnormalities, obstructions or illnesses in animals such as farmed ruminants due not least to the negative economic impact by loss or reduction in essential milk productivity. Non-invasive physiological monitoring of the mammary gland of animals such as farmed ruminants is considered vital to the healthcare of the animal and the public at large. Non-invasive, continuous and reliable physiological monitoring of the mammary gland of animals such as farmed ruminants is considered vital to the overall health status of the animal. Many non-invasive physiological monitoring systems, require the equipment which senses or detects the physiologically relevant parameters maintain an effective skin contact while at the same time relying on other established approaches such as mathematical models, numerical simulations, empiric methods or comparative analysis, which deliver inconsistent and often inaccurate readings or imaged which can be misleading to physicians. Moreover, most of the currently employed by veterinary professionals non-invasive physiological monitoring techniques reply or devices and systems which can be cumbersome and difficult to exploit with ease including ambulatory measurements, “water bath” techniques and vertical scanning. However, these methods have serious disadvantages, which mainly consist in the safety of the operator, as well as the impossibility of obtaining a reliable image. These issues are exacerbated further still when measurements and determinations are obtained from for instance restless or anxious animals. Since the udder is a highly sensitive organ in restless animals these methods present a challenge to veterinary' practitioners rendering these approached unsafe and any determination unreliable. As can be readily seen, there is an unmet need for a more accurate device or system which can effectively and reliably determine physiological characteristics, parameters, biomarkers, tissue modifications or the like, of an animal mammary gland. This unmet need is at least in part addressed by the present invention. SUMMARY OF THE INVENTION In one aspect of the present invention, there is provides a medical device comprising, a main housing being configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element; and a subsidiary module operatively associated with the main housing; wherein the agent forms a monitoring interface between the teat and the subsidiary' module enabling physiological determinations of the teat. In some embodiments of the present invention, there is provided a medical device as described herein, wherein operatively associated with the monitoring interface and the subsidiary' module is at least one physiological monitor device. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the at least one physiological monitor device senses, monitors, visualises or determines one or more physiological characteristics, parameters, biomarkers, tissue modifications or the like. In some embodiments of the present invention, there is provided a medical device as described herein, wherein at least one physiological monitor device senses, monitors, visualises or determines one or more predetermined physiological characteristics, parameters, biomarkers, tissue modifications or the like. In some embodiments of the present invention, there is provided a medical device as described herein, wherein at least one physiological monitor device senses, monitors, diagnosis or determines a condition, disorder or disease. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the physiological monitor device senses, monitors physiological parameters or determines treatment of disease or disorder continuously and / or in real-time. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the physiological monitor device comprises a sonic transducer. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the sonic transducer is an ultrasound module. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the tissue modification is one or more selected from the group consisting of mastitis, ulcerative mammillitis, lump, abnormal tissue mass, tumour, cancer teat edema, teat obstructions, haemolactia, abscess, and teat sphincter anomalies. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the agent is characterised with conductive properties which facilitate the formation of a monitoring interface between the teat and the subsidiaiy module to enable physiological determinations. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the agent is selected from the group consisting of water, phosphate buffered saline (PBS), water-based gel, ultrasound gel and the like. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the gel is ultrasound gel. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the animal teat is monitored continuously in real-time. In some embodiments of the present invention, there is provided a medical device as described herein, wherein the supporting element comprises a handle or a biasing element. In one aspect of the present invention, there is provides a method of determining the physiological characteristics of an animal teat, the method comprising the steps of: a. providing a medical device comprising a main housing configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element and a subsidiary module comprising at least one physiological monitor device operatively associated with the mam housing and the agent; b. placing the teat in the main housing configured to accommodate the teat and the agent, and c. conducting physiological determinations of the animal teat. In some embodiments of the present invention, there is provided a method of determining the physiological characteristics of an animal teat, wherein the agent is characterised with conductive properties which facilitate the formation of a monitoring interface between the teat and the subsidiary module to enable physiological determinations. In some embodiments of the present invention, there is provided a method of determining the physiological characteristics of an animal teat, wherein operatively associated with the monitoring interface and the subsidiary module is at least one physiological monitor device. In some embodiments of the present invention, there is provided a method of determining the physiological characteristics of an animal teat, wherein the physiological monitor device is an ultrasound module. In some embodiments of the present invention, there is provided a medical device as described herein or a method of determining the physiological characteristics of an animal wherein the animal is a farmed animal selected from the group consisting of sheep, goat, cow, camel, buffalo or the like. These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description, and claims. BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1. Medical device comprising supporting element (1), main housing (2) configures to accommodate an animal mammary' gland such as a teat (5) and an agent (3), and a subsidiary' module (4). FIGURE 2. Ultrasonography image of a mammary gland using the medical device of the present invention depicting the following physiological and structural features: teat orifice (1), teat canal (2), rosette of Furstenberg (3), teat w all (4), teat cistern (5) and agent accommodated in main housing (6). FIGURE 3. Medical device placed in situ on the mammary gland of an animal. FIGURE 4. Medical device comprising supporting element (1) with extendable handle (2); main housing containing an agent such as water or ultrasound gel configured to accommodate an animal mammary gland such as a teat (3); and mounting means for subsidiary module such as clamps for securing or fixing ultrasound apparatus (4). DETAILED DESCRIPTION OF THE INVENTION Throughout this disclosure, various scientific publications, patents and published patent specifications are referenced by an identifying citation. The disclosures of these publications, patents and published patent specifications are hereby incorporated by reference into the present disclosure to more fully describe the state of the art to which this disclosure pertains. As used herein, certain terms may have the following defined meanings. As used herein the term ‘‘animal” mean a vertebrate, such as a four-legged animal. Preferably the animal is a farmed animal. Preferably the animal is cow, buffalo, camel, donkey, goat, sheep, horse, moose, reindeer, yak. Preferably the patient is a cow or a buffalo. As used in the specification and the claims, the singular form “a,” “an” and “the” include singular and plural references unless the context clearly dictates otherwise. For example, the term “biomarker” includes a single or plurality of biomarkers or physiological parameters. As used herein, the term "comprising" means including, made up of, composed of encompass, consist of, constitute and incorporate. All numbers or numerals as used herein that indicate amounts, ratios of materials, physical properties of materials, and / or use are to be understood as modified or qualified by the term "about," except as otherwise explicitly indicated. As used herein, the term "about" includes the recited number or number and + / - 10% from the recited numeral or number. By way of non-limiting example, the term "about ten (10)" would encompass nine (9) to eleven (11) or 9-11. Recitation of ranges of values herein are not intended to be limiting, referring instead individually to any and all values falling within the range, unless otherwise indicated, and each separate value within such a range is incorporated into the specification as if it were individually recited herein. The term “substantially” refers to up to 80% or more of an entirety’. Recitation of ranges of values herein are not intended to be limiting, referring instead individually to any and all values falling within the range, unless otherwise indicated, and each separate value within such a range is incorporated into the specification as if it were individually recited herein. By way of example, according to the present invention, the patellar is positioned substantially centrally in the trochlear groove of the affected joint. As used herein, the term "substantially free" means that the content is sufficiently low or negligent that no appreciable danger to the patient will result from exposure during use of any of the medical devices or the methods of the present invention. For purposes of this disclosure, the term “aligned” means parallel or substantially parallel. Also, for purposes of this disclosure, the term "length" means the longest dimension of an object such as supporting element. Also, for purposes of this disclosure, the term “width” means the dimension of an object from side to side. For the purposes of this disclosure, the term “above” generally means superjacent, substantially superjacent, or higher than another object although not directly overlying the object or mammary gland such as udder or teat. Further, for purposes of this disclosure, the term “mechanical communication” generally refers to components being in direct physical contact with each other or being in indirect physical contact with each other where movement of one component affect the position of the other such as a physiological monitor device and mammary gland such as an udder or teat. As used herein, the term “at least one”, unless otherwise indicated, refers to one or more for example images, examinations, biomarker, physiological parameter, supporting element, subsidiary module, physiological monitor integer, tissue modification, disease or conditions which can be determined by the device of the present invention or generally used or measured in the methods of the present invention. By way of example, at least one examination means one examination or type of examination, it also refers to 2 examinations or A pes of examination, it also refers to 3 examinations or types of examination, it also refers to 4 examinations or types of examination or more; at least one image means one image derived from any scanning device, it also refers to 2 images derived from any scanning device or more, it also refers to 3 images derived from any scanning device or more, it also refers to 4 images derived from any scanning device or more. A scanning device includes a sonic transducer, ultrasound module or the like. By way of example, at least one tissue modification includes at least one or more selected from the group consisting of mastitis, ulcerative mammillitis, tumour, cancer teat edema, teat obstructions, haemolactia, abscess, and teat sphincter anomalies. In some embodiments, the at least one physiological monitor device senses, monitors, diagnosis or determines a condition, disorder or disease The term “biomarker” as used herein, refers to a characteristic that can be objectively measured and evaluated as an indicator of normal and disease processes or physiological response. A “biomarkef’ is a parameter that can be used to measure the onset or progress of disease or condition or the effect of treatment. The parameter can be chemical, physical, biological, molecular, epigenetic or behavioural. Preferably the chemical, physical, biological, epigenetic or molecular parameter affects or influences the mammary gland of an animal. Preferably the chemical, physical, biological, epigenetic or molecular parameter affects or influences the lactation of the mammary gland of an animal. Preferably the chemical, physical, biological, epigenetic or molecular parameter affects or influences the involution of the mammary' gland of an animal. Preferably, the disease or condition is mastitis. Preferably the disease or condition is ulcerative mammillitis. Preferably the disease or condition is tumour of the mammary gland. Preferably the disease or condition is cancer teat edema. Preferably the disease or condition is teat obstructions. Preferably the disease or condition is haemolactia. Preferably the disease or condition is abscess. Preferably the disease or condition is teat sphincter anomalies. Preferably the disease or condition is a physiologically abnormal mass as compared to placebo or control. Preferably the disease or condition is an abnormal tissue mass as compared to placebo or control. Preferably the disease or condition is a lump. Preferably the disease or condition is a tumour mass. Preferably the disease or condition is a tumour lump. As used herein, the term “treatment” or “treating” refers to an amelioration, prophylaxis, or reversal of a disease, condition or disorder, or of at least one discernible symptom or condition thereof in an animal. It is also contemplated that the treatment, as described herein throughout and based on data and images, leads to one or more of clinical improvement, reduction in the severity of a symptom or disease and reduction in recurrence. It is also contemplated that the treatment, as described herein throughout and based on data and images, leads to clinical improvement and enhancement of rate of recovery. In some embodiments, “treatment” or “treating” refers to an amelioration, prophylaxis, or reversal of at least one measurable physical parameter related to the disease or disorder being treated, not necessarily discernible in or by the animal. In some embodiments, “treatment” or “treating” refers to inhibiting or slowing the progression of a disease, disorder or condition, either physically, e.g., stabilisation of a discernible symptom, physiologically, e.g. stabilisation of a physical parameter, or both. In some embodiments, “treatment” leads to partial or complete remission of the disease, condition or disorder. In some embodiments, “treatment” leads to clinical improvement in an animal affected by mastitis. In some embodiments, “treatment” leads to reduction in the severity of disease in an animal affected by mastitis. In some embodiments, “treatment” leads to reduction in the recurrence of disease in an animal affected by mastitis. In some embodiments, “treatment” leads to clinical improvement and enhancement of the rate of recovery of an animal affected by mastitis. In some embodiments, “treatment” leads to clinical improvement or substantial reversal of mastitis, ulcerative mammillitis, tumour, cancer teat edema, teat obstructions, haemolactia, abscess, and teat sphincter anomalies of the animal. In some embodiments, “treatment” leads to return to physiologically normal involution of the mammary gland of the animal. Throughout the specification, when a portion is “connected” or “coupled” to another portion, such as monitoring interface to subsidiary module or main housing to supporting element, this includes not only a case of being “directly connected or coupled” but also a case of being “electrically connected” with another element interposed therebetween, as well as for example “WiFi connected”, “Bluetooth connected” or the like. In some embodiments of the present invention, “connected” or “coupled” means operatively associated. In some embodiments, the subsidiaiy module is operatively associated with the main housing. In some embodiments, operatively associated with the monitoring interface and the subsidiaiy module is at least one physiological monitor device. For purposes of this disclosure, the term “length” means the longest dimension of an object. Also, for purposes of this disclosure, the term “width” means the dimension of an object or gland from side to side. For the purposes of this disclosure, the term “above” generally means supeijacent, substantially superjacent, or higher than another object although not directly overlying the object or gland. Further, for purposes of this disclosure, the term “mechanical communication” generally refers to components being in direct physical contact with each other or being in indirect physical contact with each other where movement of one component affect the position of the other. Throughout the specification, when a member or integer is said to be located “on” another member or integer, this includes not only a case in which the member or integer is in contact with another member or integer but also a case in which there is another member or integer between the two members or integers. As an example, an agent forms a monitoring interface between a mammary gland such as a teat and a subsidiary7 module. As used herein, the term “alteration” may be used interchangeably with the terms, “alter” or “modify” such as increase or decrease in the level of a metabolite such as a chemical or a biomarker detected and / or analysed and / or monitored, by the device of the present invention. In some embodiments, the alteration is at least 0.001%, 0.005%, 0.01%, 0.05%, 0.08%, 0.1%, 0.15%, 0.2%, 0.4%, 1%, 2%, 2.5%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or greater compared to control or base level. In some embodiments the alteration or delay may be at least 0.1, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10-fold or greater compared to control or base level. In some embodiments the alteration of the parameter is statistically significant. In some embodiments the effectiveness or the device of the present invention is determined qualitatively. In some embodiments the alteration is determined qualitatively. In some embodiments the alteration is determined quantitatively. In some embodiments, alteration is assessed by a qualitative step and / or a quantifying step. In further embodiments, the qualitative step and / or a quantifying step is performed on a sample using the device of the present invention. In further embodiments, the qualitative step and / or a quantifying step is performed on a subject using the device of the present invention. In further embodiments, the qualitative step and / or a quantifying step is performed continuously. In further embodiments, the qualitative step and / or a quantifying step is performed in real-time. In further embodiments, the qualitative step and / or a quantifying step is performed continuously in real-time. In further embodiments, the present disclosure the capillaiy pulse wave and the arterial pulse wave are determined simultaneously, sequentially or concomitantly. In further embodiments, the present disclosure may also be implemented in the form of a recording medium including instructions executable by a computer, such as a program module executed by the computer. Computer-readable media may be any available media that may be accessed by a computer and include both volatile and nonvolatile media and removable and nonremovable media. In addition, the computer-readable media may include all computer storage media. The computer storage media includes both volatile and nonvolatile media and removable and non-removable media implemented by any method or technology of storing information, such as a computer readable instruction, a data structure, a program module, and other data. The storage may be in the iCloud. The use of any and all examples, or exemplary’ language (“e.g.,” "such as,” or the like) provided herein, is intended merely to better illuminate the embodiments and does not pose a limitation on the scope of the embodiments or the claims. No language in the specification should be construed as indicating any unclaimed element as essential to the practice of the disclosed embodiments. In the following description, it is understood that terms such as “first,” “second,” “top,” “bottom,” “up,” “down”, "upper", "lower", "above", "below", "beneath", "front", "back", "over", "under", "left", "right", “dorsal”, “volar”, “palm side”, “back side” etc. are used with reference to the orientation of some of the components of the medical device of the present invention. Since constituents or components in various embodiments described here can be positioned in anumber of different orientations, locations of the body, directional terminology7 is used for purposes of illustration only and is in no way limiting. The directional terminology’ is intended to be construed broadly, and therefore should not be interpreted to preclude components being oriented in different ways. The disclosure illustratively described herein can suitably be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. Thus, for example, the terms “comprising”, “including,” containing”, etc. shall be read expansively and without limitation. The following detailed description is of the best currently contemplated modes of carry ing out exemplary embodiments of the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims. Broadly, an embodiment of the present invention provides a medical device, comprising: a. a main housing being configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element; and b. a subsidiary module operatively associated with the main housing; wherein the agent forms a monitoring interface between the teat and subsidiary module enabling physiological determinations of the teat. Referring to Figure 1, the present invention may include a medical device comprising supporting element (1), main housing (2) configured to accommodate a mammary gland of an animal such as a teat (5), a monitoring interface facilitated by an agent (3), and a subsidiary module (4). According to some embodiments, operatively associated with the monitoring interface and contained in the main housing and the subsidiary module, are one or more physiological monitor device or integer. According to some embodiments, operatively associated with the monitoring interface and contained in the main housing are one or more physiological monitor device or integer. According to some embodiments, operatively associated with the monitoring interface and the subsidiary' module, are one or more physiological monitor device or integer. In some embodiments of the present invention, the monitoring interface, the main housing and the subsidiary module may be connected via Bluetooth, WiFi or the like. In some embodiments of the present invention, the at least one physiological monitor device senses, monitors, visualises or determines one or more physiological characteristics, parameters, biomarkers, tissue modifications or the like. In some embodiments of the present invention, the at least one physiological monitor device is capable of qualitatively sensing, monitoring, visualising or determining one or more physiological characteristics, parameters, biomarkers, tissue modifications or the like. In some embodiments of the present invention, the at least one physiological monitor device is capable of generating improved quality of sensing, monitoring, visualising or determining of one or more physiological characteristics, parameters, biomarkers, tissue modifications or the like compared to previously employed methods such as ambulatory measurements, “water bath” techniques and vertical scanning. In some embodiments of the present invention, the at least one physiological monitor device senses, monitors, visualises or determines one or more predetermined physiological characteristics, parameters, biomarkers, tissue modifications or the like. In some embodiments of the present invention, the at least one physiological monitor device senses, monitors, diagnosis or determines a condition, disorder or disease. In some embodiments of the present invention, the physiological monitor device senses, monitors or determines treatment of disease or disorder continuously and / or in real-time. In some embodiments of the present invention, the physiological monitor device or integer comprises a sonic transducer. In some embodiments the sonic transducer is suitable for medical imaging. In some embodiments the sonic transducer is suitable for medical imaging of an animal mammary gland. In some embodiments the sonic transducer is suitable for medical imaging of an animal teat. In some embodiments the sonic transducer is a portable ultrasound machine. Preferably the portable ultrasound machine incorporates both an ultrasound transducer and an imaging system. In some embodiments of the present invention, the portable ultrasound device can be detect or determine the presence of a lump in the mammary gland such as a teat comprising a main housing configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element; and a subsidiary module operatively associated with the main housing; wherein the agent forms a monitoring interface between the teat and subsidiary module enabling physiological determinations of the teat, and generating ultrasound image information on the basis of the received ultrasound signal; and a communication unit for transmitting the ultrasound image information to an external terminal. In some embodiments an agent alters the relationship between the mammary gland such as the teat and the subsidiary' module. In some embodiments an agent effectively alters the relationship between the mammary gland such as the teat and the subsidiary module such as the physiological monitor device or integer. In some embodiments of the present invention, the sonic transducer is an ultrasound module. Turning to Figure 3, showing an in situ use of the device of the present invention comprising a subsidiary device such as a vertical ultrasound probe (3) and transducer. In some embodiments, the ultrasonic transducer (2) is operatively secured to the main housing (2) as shown in Figure 1. The transducer (2) in Figure 3 converts alternating current energy above 20 KHz to mechanical vibrations of the same frequency to produce acoustic waves. The transducer (2) can be connected to a conventional drive connected via a plug to a conventional AC supply. Turning to Figure 4 showing a medical device comprising supporting element (1) with extendable handle (2); main housing containing an agent such as water or ultrasound gel configured to accommodate an animal mammary gland such as a teat (3); and mounting means for subsidiary module such as clamps for securing or fixing ultrasound apparatus (4). In some embodiments of the present invention, the tissue modification is one or more selected from the group consisting of mastitis, ulcerative mammillitis, lump, abnormal tissue mass, tumour, cancer teat edema, teat obstructions, haemolactia, abscess, and teat sphincter anomalies. In some embodiments of the present invention, the agent is characterised with conductive properties which facilitate the formation of a monitoring interface between the mammary gland such as the teat and the subsidiary module to enable physiological determinations. Preferably, the agent is hypoallergenic. Preferably, the agent is sterile. Preferably, the agent is non-sterile. In some embodiments of the present invention, the agent is no-sterile. Without w ishing to be bound by theory, it is contemplated that within the context of the present invention, the agent acts as a coupling conduit during the used of the device and the methods described herein such as diagnostic imaging procedures or determining the physiological characteristics or parameters of a mammary gland such as a teat. Referring here to Figures 1 when an ultrasound transducer (4) is placed against the main housing of the device (2) of the present invention which main housing is configured to accommodate the mammary gland (5) which is itself in intimate and continuous contact with the agent (3), ultrasound transducer sends or transmits through the agent high-frequency sound waves such as above 20 KHz into the mammary gland such as the teat. These sound waves are effectively transmitted thought the agent and bounce back from the tissue within the mammary gland such as the teat, creating a reflection that is captured back by the transducer and used to create an image. Without the employ of an agent, the high frequency sound waves would not be able to penetrate the skin of the mammaiy gland of the animal such as the teat as effectively and without interference, resulting in a fuzzy or distorted image. This would generate data such as reflection data and images, which are unreliable for physiological determinations as contemplated by the present invention. These issues are exacerbated further still when any measurements, reflections, determinations and / or images are obtained from for instance restless or anxious animals. In addition, since the mammaiy gland such as the udder or the teat is a highly sensitive organ in restless animals this present a challenge to veterinary' practitioners when try ing to collect safely reliable physiological determinations. The present invention provides a more accurate device or system which can effectively and reliably determine physiological characteristics, parameters, biomarkers, tissue modifications or the like, of an animal mammary gland. The present invention provides a safer approach to animal examination generating effective and reliably determinations of physiological characteristics, parameters, biomarkers, tissue modifications or the like, of an animal mammary gland. Referring here to Figure 2 showing an ultrasonography image of a mammary gland using the medical device of the present invention depicting the following physiological and structural features: teat orifice (1), teat canal (2), rosette of Furstenberg (3), teat wall (4), teat cistem (5) and agent accommodated in main housing (6). In some embodiments of the present invention, the agent is selected from the group consisting of water, phosphate buffered saline (PBS), water-based gel, ultrasound gel and the like. In some embodiments the agent is de-ionised water. It is intended within the context of the present invention that the agent alters the interaction between the mammary gland such as the teat and the subsidiary module enabling physiological determinations of the teat. In some embodiments of the present invention, wherein the gel is ultrasound gel. In some embodiment, agent forms an effective skin contact and thus the formation of a monitoring interface between the subsidiary module and the teat which facilitated improved quality physiological determinations to be generated. In some embodiments of the present invention, the animal teat is monitored continuously in realtime. In some embodiments of the present invention, the operatively associated physiological monitor integers may include sensors, biomarkers, or the like, which can sense or monitor physiological parameters in real-time. In some embodiments of the present invention, the operatively associated physiological monitor integers may include sensors, biomarkers, or the like, which can sense or monitor predetermined physiological parameters. In some embodiments of the present invention, the operatively associated physiological monitor integers may include sensors, biomarkers, or the like, which can sense or monitor predetermined physiological parameters in real-time. In some embodiments of the present invention, the operatively associated physiological monitor integers may include sensors, biomarkers, or the like, which can sense or monitor predetermined physiological parameters continuously in real-time. In some embodiments of the present invention, the operatively associated physiological monitor integers may include sensors, biomarkers, or the like, which can sense, monitor or determine treatment of disease or disorder continuously and / or in real-time. In some embodiments the main housing incorporating a supporting element. In some embodiments the supporting element comprises a handle or a biasing element. In some embodiments the supporting element comprises a securing element. In some embodiments the handle can be a rod or a telescopic pole. In some embodiments the supporting element comprises a biasing element. In some embodiments the supporting element comprises a securing element. In some embodiments the securing element can be a strap. In some embodiment, the biasing component may be a resilient material such as elastic, thermoplastic, rubber or spring. In some further embodiments the securing element can be a handle strap. Generally speaking, configuration of the securing elements and the biasing component are intended to hold the main housing and the monitoring interface to facilitate an effective skin contact with the mammary gland or teat. According to a further aspect of the present invention, there is provided a method for determining the physiological characteristics or parameters of an animal teat, the method comprising the steps of: a. providing a medical device comprising a main housing configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element and a subsidiary module comprising at least one physiological monitor device operatively associated with the main housing and the agent; b. placing the teat in the main housing configured to accommodate the teat and the agent, and c. conducting physiological determinations of the animal teat. Monitoring, such as continuous monitoring or continuous monitoring in real-time of physiological characteristics of the mammary gland such as a teat of an animal, is also contemplated in the present invention which can enable transformative diagnostic and further management tools. It is also contemplated with the present invention that determinations, images and other forms of data which are collected by the medical device of the present invention can be processed and presented as mean standard deviation (mSD). In some embodiments of the present invention, data which are collected by the medical device of the present invention can be correlated using computational software analysis. In some embodiments of the present invention, data which are collected by the medical device of the present invention can be correlated using artificial intelligence (AI). In some embodiments of the present invention, data which are collected by the medical device of the present invention are correlated using self-learning AI. Data Processing In some embodiments, the data collected from the device can be processed remotely. After normalisation and pre-processing of the data, MetIDQ™ software (Biocrates) can be used for peak integration and calculation of for example mammary gland specific molecular biomarker, tissue abnormality indicators, epigenetic signatures and the like. If the measurements were outside the measurable range, values were imputed as follows: concentrations below the detection limit (LOD) per was set to half of the lowest measured concentrations. Concentrations below the limit of quantification (LOQ) can be set to half of the LOQ. In addition, concentration higher than the highest calibration standard concentration can be set to the highest standard concentrations. In some further embodiments, the data collected from the device has to be processed using machine learning and simulated training data. An embodiment of the present disclosure may also be implemented in the form of a recording medium including instructions executable by a computer, such as a program module executed by the computer. Computer-readable media may be any available media that may be accessed by a computer and include both volatile and nonvolatile media and removable and non-removable media. In addition, the computer-readable media may include all computer storage media. The computer storage media includes both volatile and nonvolatile media and removable and nonremovable media implemented by any method or technology of storing information, such as a computer readable instruction, a data structure, a program module, and other data. Statistical Analysis Analysis can be carried out on the device itself or remotely using systems and software programs known in the art such as for example IBM SPSS version 25. Variables in measurement and data with skewed distributions can be log-transformed to ensure normality. Comparisons can be performed with t-test, Wilcoxon-Mann-Whitney, and one-way ANOVA as appropriate. Significance was defined as p<0.05. Non-parametric tests were used for comparing ordinal or non-normal variables. Data can be presented as mean standard deviation (mSD). Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the disclosure claimed. It will also be appreciated that the device(s), method(s), use(s), detector(s), sensor(s), physiological biomarker(s) may be subject to numerous rearrangements, modifications and substitutions w ithout departing from the scope of the present disclosure as set forth and defined by the following claims. * * *

Claims

1. A medical device comprising,a. a main housing being configured to accommodate an animal teat and an agent, the main housing incorporating a supporting element; andb. a subsidiary module operatively associated with the main housing;wherein the agent forms a monitoring interface between the teat and subsidiary module enabling physiological determinations of the teat.

2. A medical device according to claim 1, wherein operatively associated with the monitoring interface and the subsidiary module is at least one physiological monitor device or integer.

3. A medical device according to claim 2, wherein the at least one physiological monitor device senses, monitors, visualises or determines one or more physiological characteristics, parameters, biomarkers, tissue modifications or the like.

4. A medical device according to any one of claims 2 or 3, wherein the at least one physiological monitor device senses, monitors, visualises or determines one or more predetermined physiological characteristics, parameters, biomarkers, tissue modifications or the like.

5. A medical device according to any one of claims 2 to 4, wherein at least one physiological monitor device senses, monitors, diagnosis or determines a condition, disorder or disease.

6. A medical device according to any one of claims 2 to 5, wherein the physiological monitor device senses, monitors or determines treatment of disease or disorder continuously and / or in real-time.

7. A medical device according to any one of claims 2 to 6, wherein the physiological monitor device or integer comprises a sonic transducer.

8. A medical device according to claim 7, wherein the sonic transducer is an ultrasound module.

9. A medical device according to any one of claims 1 to 7, wherein tire tissue modification is one or more selected from the group consisting of mastitis, ulcerative mammillitis, lump, abnormal tissue mass, tumour, cancer teat edema, teat obstructions, hacmolactia. abscess, and teat sphincter anomalies.

10. A medical device according to anyone of claims 1 to 9, wherein the agent is characterised with conductive properties which facilitate the formation of a monitoring interface between the teat and the subsidiary module to enable physiological determinations.

11. A medical device according to claim 10, wherein the agent is selected from the group consisting of water, phosphate buffered saline (PBS), water-based gel, ultrasound gel and the like.

12. A medical device according to claim 11, wherein the gel is ultrasound gel.

13. A medical device according to any one of claims 1 to 12, wherein tire animal teat is monitored continuously in real-time.

14. A medical device according to anyone of the preceding claims, wherein the supporting element comprises a handle or a biasing element.

15. A method of determining the physiological characteristics or parameters of an animal teat, the method comprising the steps of:a. providing a medical device comprising a main housing configured to accommodate an animal teat and an agent, tire main housing incorporating a supporting element and a subsidiary module comprising at least one physiological monitor device operatively associated with tire main housing and the agent;b. placing the teat in the main housing configured to accommodate the teat and the agent, andc. conducting physiological determinations of the animal teat.

16. A method according to claim 15, wherein the agent is characterised with conductive properties which facilitate the formation of a monitoring interface between the teat and the subsidiary module to enable physiological determinations.

17. A method according to anyone of claims 15 or 16, wherein operatively associated with the monitoring interface and the subsidiary module is at least one physiological monitor device.

18. A method according to anyone of claims 15 to 17, wherein the physiological monitor device is an ultrasound module.

19. A medical device according to anyone of claims 1 to 14 or a method according to anyone of claims 15 to 18, wherein the animal is a farmed animal selected from the group consisting of sheep, goat, cow, camel, buffalo or the like.

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