CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national stage application, filed under 35 U.S.C. § 371, of International Application No. PCT/GB2015/052648, filed Sep. 11, 2015, which claims priority to GB Application Serial No. 1416453.7, filed on Sep. 17, 2014, entitled “DEVICE” and GB 1416457.8, filed on Sep. 17, 2014, entitled “DEVICE,” the entire contents of which are incorporated herein by reference for any and all purposes.

FIELD

The present invention relates to a sampling device. The sampling device comprises a separate compartment that is ejected creating an increased space or volume for a sample to be stored. The sampling device of the present invention is suitable for collecting a sample in an aquaculture environment, enclosed system or in the gastrointestinal tract of a human or an animal. The invention also relates to a method of orally administering the device to an animal and recovering the device to carry out analysis on the collected sample for diagnosing the health of the gastrointestinal tract and determining nutrient absorption and digestibility.

BACKGROUND

The ability to directly sample substances within the gastrointestinal tract of an animal is a key enabling technology for diagnosing the health of the gastrointestinal tract; understanding ileal digestion, fermentation in the colon and for investigating the relationship between specific dietary components and the biological, chemical and physio-chemical properties in the gastrointestinal tract of humans and/or animals. This includes nutrient absorption, drug metabolism, microorganism distribution, immunological status and so on.

Analyzing a sample of substance, such as a gas, a solid particle or a liquid from the gastrointestinal tract of an animal, can provide information on the pH, enzyme activity, microbial load/content and molecular composition of the sampled material including nutrient load and degree of processing information enabling the assessment of health status and diagnosis of diseases, and in particular diseases of the gastrointestinal tract can also be obtained through determination of immune factors or general immunological status, characterisation of the microflora present and presence/absence of microbial pathogens or microbes associated with health.

Early detection, identification of and location of abnormal conditions can be critical for definitive diagnosis and/or treating various pathologies. Particular control over the site of digesta sampling is also vital to the understanding of health and disease since conditions are generally site specific for example relating to either the stomach, ileum or colon as opposed to affecting the entire gastrointestinal tract. Site specific sample acquisition is also of use for understanding dietary impact and nutrition, for example, ilea processing is an important factor in diet design since the efficiency of digestion and absorption within the small intestine impacts on the luminal contents present in the distal portion of the gastrointestinal tract. Fermentation by the intestinal flora within the colon is dependent on the luminal contents reaching the colon and hence factors such as incomplete protein digestion have been associated with the formation of toxic compounds, including ammonia, di-hydrogen sulphide, in-doles and phenols, which in turn have been shown to increase the risk of colon cancer in humans. In the design of diets for “production animals”, it is also important to enhance the efficiency of nutrient availability in foodstuffs and the environmental impact of waste products from the animal.

Whilst total apparent digestibility (as measured by the percentage of ingested nutrient that is recovered in the faeces) is a key measure, this methodology has a number of shortcomings, due to the contamination of faeces with metabolic waste products and substances of non-dietary origin. Ileal digestibility is therefore a more appropriate measure of nutrient delivery. Furthermore, the outflow of the terminal ileum into the caecum can be considered as the substrate upon which the hind gut microflora act. The colonic digesta or luminal contents may therefore provide a predictor or allow assessment of the nutrients available for fermentation by the resident gastrointestinal microflora. Consequently, the ability to measure a broad range of chemical (e.g. protein, carbohydrates, fats, non-starch polysaccharides, micronutrients, anti-nutritional factors), biological and physio-chemical (e.g. viscosity) properties from within the ileal and colonic digesta represents a significant development that may in turn enable a step-change in our understanding of the effects of specific dietary components on digestive processes and its products. Such digestion products may include faecal characteristics such as faeces quality and consistency and intestinal gas or flatulence. The development of these enabling technologies may also, enable diagnosis and research into gastrointestinal diseases.

There is an ongoing need to improve known sampling devices, such that a larger volume of sample may be acquired, and sampling of liquids ranging in viscosity as well as solid samples can be acquired.

BRIEF DESCRIPTION

A sampling device is provided herein. The sampling device allows a greater range of analytical tests to be carried out on the sample and enhance the range of samples for acquisition. Furthermore, the sampling device has the capability to alter the point within the gastrointestinal tract at which the sample is captured, thereby allowing investigation of the changes in factors involved in digestion (pH, enzymes emulsifying agents etc.), dietary processing; nutrient absorption; microbial populations; immune factors and digesta viscosity throughout the length of the gastrointestinal lumen. Sampling may therefore proceed within the stomach, ileum, colon and caecum allowing sampling site to be adjusted based on the nature of the sample required.

The device of the present invention is simple, inexpensive, reliable and easy to use, without the need for constant monitoring and may be reusable. The device of the present invention can be recovered and the sample easily extracted and analysed using a variety of biological, chemical and physical assays. Both liquid and solid substances can be sampled by the device of the present invention.

The device of the invention is able to log a change in the environment over a long period of time, e.g. for 24 hours. In particular, the change in the environment along the gastrointestinal tract of an animal. The device of the invention is able to download the data stored to a computer and be easily reprogrammed to be reused. The device of the invention is able to detect and log the time pH and/or temperature at which the sample is obtained.

In particular, the device of the invention is able to collect a large amount of sample as a result of its separate compartment being ejected creating an increased volume or space for a sample to be collected and stored.

In a first aspect, a sampling device is provided. The sampling device comprises a housing, the housing comprising a chamber, at least an opening, an actuation means and a separate compartment. The separate compartment is releasably retained within the housing by a retention means and is ejectable from the housing. The device may be reuseable.

The at least one opening may be an inlet or an outlet and may comprise a one-way valve.

The actuation means may comprise a plunger, a spring, ora combination of these. The actuation means is coupled at one end of the housing of the sampling device and the separate compartment is releasably retained by a retention means within the housing at the opposing end of the sampling device.

The actuation means causes an internal substance to be drawn in through the opening into the chamber and also pushes the separate compartment through the interior of the housing until the separate compartment is ejected therefrom. The actuation means may be prevented from being ejected from the housing by a stopper, e.g., a lip, pin, lug, or protrusion, at the end of the housing from which the separate compartment is ejected from the sampling device. Increased space or volume for receiving and storing a sample within the chamber of the sampling device is provided by the ejection of the separate compartment out of the housing by the actuation means.

The retention means comprises a material that reacts to changes in the external environment of the device, e.g., the material may react to pH, temperature, light, moisture, solute concentration or enzymatic degradation. The material of the retention means may be degradable, digestible or soluble. The retention means may both react to changes in the environment external to the device, and also be degradable, digestible or soluble.

The retention means may also be activated by a trigger such as a piezoelectric means, a shape memory alloy, a muscle wire, or a sacrificial fuse. The trigger, in turn, may be activated, and/or the retention means released in response to, a change in pH, a change in temperature, a change in moisture, a change in solute concentration, a change in enzyme concentration or a change in light and/or is activated at a pre-determined time and/or at a pre-determined pH and/or at a pre-determined temperature and/or pre-determined moisture level and/or pre-determined solute concentration and/or pre-determined enzyme activity or concentration.

The retention means and/or the trigger means may also be activated automatically, pre-programmed to activate at a specific time or in response to a specific condition and/or activated remotely. In some embodiments, the retention means is a bayonet mount that is activated by a trigger means. In others, the retention means is a rubber O-ring washer that is activated by a trigger means.

The retention means may further comprise an interlocking mechanism between the housing and the separate compartment and may be fastened and/or released by rotatory, radial or linear motion or means. One example of a suitable rotary interlocking mechanism is a bayonet. One example of a suitable radial interlocking mechanism is a rubber O-ring. One example of a linear interlocking mechanism is a pin that pushes the separate compartment into place.

After the actuation means and/or retention means is activated, the separate compartment is at least partially released and at least partly disengaged from the actuating means. Desirably, the separate compartment is completely ejected from the housing of the sampling device, so that the device and the separate compartment may be recovered separately.

The separate compartment comprises at least a battery, a sensor and a microprocessor. The sensor may be a pH sensor, a temperature sensor, or a combination of these. The separate compartment may further comprise a switch, such as a pressure switch, that is adapted to record the timing at which the separate compartment is ejected from the housing of the sampling device.

In a second aspect, a method of obtaining a sample from the gastrointestinal tract of an animal is provided. The method comprises orally administering the device as claimed in any one of the previous clauses to the animal and recovering the device. The separate compartment may also desirably be recovered. The sample within the device may then be tested as desired. The animal may be a human, a companion animal, such as a horse, dog or cat, or a farm animal or a production animal such as a horse, cow, sheep and/or chicken.

