In Vivo Device and Method for Researching GI Tract Processes, Microbes, and Variables Associated with Illnesses and Diseases

• US 20140163416A1
• Filed: 06/28/2013
• Published: 06/12/2014
• Est. Priority Date: 11/16/2012
• Status: Active Grant

• Current Assignee: Shuck, L. Zane
• Original Assignee: Shuck, L. Zane
• Inventors: Shuck, L. Zane
• Granted Patent: US 8,915,863 B2
• Time in Patent Office: Days
• US Class Current: 600/562
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions

Abstract

An orally ingested capsule has capabilities of sampling gut substances and microbes before, during and after delivery of system perturbation substances, to the gut at any point or time. Sensors are provided to simultaneously measure, monitor, record, and transmit data in real time obtained within the exact vicinity of substance deployment and microbial assisted digestive processes occur. In vivo collected samples are collected and preserved for extensive in vitro analysis. Digestive processes and dysfunctions involving proteins that result in “gluten sensitivities” and dozens of gut-based diseases that develop in stages, and have been mysteries for over 2,000 years, can be analyzed. The capabilities were developed to permit research within the heretofore inaccessible and important regions of the small intestine where villi functions are compromised, and in the upper colon. Special focus includes determining roles microbes and their byproduct substances in cascade play in autoimmune system responses and diseases.

Claims

I. I. In addition to the capabilities of Capsule A device of simultaneously sampling, preserving, and extracting microbes and other matter from the gut utilizing battery-powered, micro-motor driven belts with pockets, this invention is a device and method that also delivers protected masses in belt pockets to the human gut, exposes or deploys them upon command, and simultaneously samples, extracts, and preserves adjacent matter, using different or same pockets in belt, from the gut in proximity to the delivered mass upon command, and makes simultaneous measurements and transmits said data upon command.

I-1. I-1. As in I above, wherein certain pockets within said belt(s) are indexed for selection and deployment into service, independently or simultaneously, either to deliver, or sample, mass upon command at any point in time “

t”

or location “

x”

along the entire GI tract. Said indexing is accomplished by telemeter remote switching, using reversible and/or stepping micro-motor driven belts.

I-2. I-2. As in I above, wherein belt 1 is a sampling belt with start/stop provisions and sealed identical as in Capsule A, but in addition, is divided into two belts 1-a and 1-b, that straddle an in-between belt 2, which is used for mass delivery and the pockets are opened or closed upon command Purpose of this arrangement is to create the capability to inject matter, of any substance or microbe, into the gut at any time “

t”

or point “

x”

, and immediately in the same vicinity, and simultaneously measure the consequences of said injected substance on both sides of the injection to prove cause/effect relationships. Said straddle arrangement provides the capability of measuring said consequences, or system perturbation, for any upstream or downstream orientation of Capsule B within the gut, since its elongated shape will result in one or the other positions within the gut. Furthermore, wherein said straddle belt arrangement eliminates uncertainty in cause/effect relationships, and greatly reduces by orders of magnitude in this case the number of extraneous variables for analysis and modeling purposes. Such elimination of orders of magnitude of variables can greatly enhance microbiome associations, different taxonomic level and taxometric investigations above species to below strains or alleles, and for example, sequencing at the taxonomic phylum level of microbes associated with individual foods, or proteins.

I-3. I-3. As in I above, wherein a third belt 3 is positioned adjacent to one other side of belts 1-a or 1-b and containing a plurality of sensor/transducer/transmitter components inside individual belt pockets that can individually or in combination, be selected upon command to expose sensors/transducers to the immediate gut environment (without interference and prior to, during, and post injection of substances from belt 2) to immediately measure cause/effect relationships with background data simultaneously any detectable changes, of any detectable phenomena, and of any disciplinary nature. Exposing sealed sensors upon command prevents sensor exposure to the hazardous acidic conditions of range pH of 2 or 3 in the stomach, unless otherwise chosen. Examples of said sensors include, but are not limited to, noise or acoustic waves, pH, temperature, pressure, electrical conductivity/resistance, opacity, reflectivity.

I-4. I-4. As in I-2 above, wherein following a period of exposure “

t”

of substances in one or more belt pockets to the gut environment, the pocket is closed and sealed suitable for solids, liquids, gases, and microbe, later in vitro sample analysis. One example of purpose is the substances contained in the pockets may be specific microbe baits, or other FDA approved chemicals, or other foods that when processed by microbes create or possess specific chemical, electrical, physical, toxicity, or other distinct characteristics, that may lead to an understanding of gluten based toxins that create an auto immune response, and said toxins can thereby be analyzed as to origin, process and content. In as much as passage of food products through the gut, and their digestive process is a function of time, it is further claimed that this invented method and process allows not only for a single snapshot sample testing, but a dynamic, time-dependent digestive process to be sampled (and thereby in vitro analyzed) in a semi-continuous or discrete sampling manner, and simultaneously, due to multiple belt pockets, including determining direct cause/effect relationships anywhere within selected sites, and throughout the entire GI tract in one pass.

I-5. I-5. As in claim I-2 above wherein belt 2 pockets may contain substances that can be released, in any however improbable situation of the capsule B being stuck, and wherein such FDA approved substances as laxatives, dilation chemicals, vinegar, or olive oil can be discharged, as in “

a rescue exercise”

feature to facilitate either disintegrating the food, or capsule component blockage, enlarge the aperture or existing gut diameter, or lubricate the gut to flush the total blockage substances of whatever nature, downstream. Included in this claim is the important capability of slow release of olive oil in the portion of the colon where most of the water has been extracted.

I-6. I-6. As in claim I-4, wherein as passage of food products through the gut and their digestive process is a function of time, it is further claimed that this invented method and process allows not only for a single snapshot sample testing, but a dynamic, time-dependent digestive process to be sampled and thereby analyzed, including the exposure of the same bait products from different pockets at delta time intervals apart, and controlled exposure times suitable to arrive at, for example, effective macro-level “

reaction rate”

or “

rate-processing constants”

for diagnostic, analysis, and modeling purposes. The significance of such capability could be manifested such that the “

microbe-assisted, biochemical reaction rates of digestion”

at a particular gut cross section “

x”

may be significant to healthy versus unhealthy conditions for diagnosis, as pertain to the conversion and absorption of nutrients, especially by compromised villi. Likewise, the rates of process creation of toxins are essential for determining causes of toxins associated with gluten sensitivities and Celiac.

I-7. I-7. As in claim I-6 wherein, likewise this Capsule B invention can create and introduce time-dependent controlled processes and control variables to provide the feasibility for investigation of the time-dependent rates of process creation of toxins essential for determining causes of toxins associated with gluten sensitivities and Celiac. Thus, this Capsule B claimed capability also provides for and facilitates the feasibility of discovery of fundamental dynamic stages of protein transformation processes in the gut involving polypeptides, peptide bonds, ribosomes, tRNA, mRNA, at the molecular level, along with specific microbe strain roles, via in vitro investigation. Although for convenience, general reference herein has been made to microbes, microbiota, and bacteria strains associated with gut fluids, it also explicitly includes intraspecies, and however unlikely, other potential actors, such as, archaea, viruses, and retroviruses.

II. II. Capsule B now includes a belt with pockets containing substances being delivered to the gut as in claim I and I-2, but with a thin film covering, that when exposed to the gut environment, such as by opening a housing port, still maintains the contents inside the pocket sealed from the chyme and all gut content matter, in general.

II-1. II-1. As in claim II whereas, said belt pocket film is of a specific design substance or material, that when attacked in some biochemical manner becomes dissolved, thereby exposing the contents of said belt pocket to the gut adjacent matter of whatever chemical or microbial content.

II-2. II-2. As in claim II, except said film of a specific indexed pocket is of specific design substance to attract some specific strain or species of bacteria or other microbe as its specific preferred food, in contrast to the preferred foods of other strains or species of microbes. Whereas also, other adjacent pockets in the same belt may or may not contain the same exact substances, and the pocket covering films may be of other specific design substances to attract same or other microbes of a preferred food, and all pockets of which can be closed and preserved for in vitro sampling, testing and analysis.

II-3. II-3. As in claim II-2, wherein, a plurality of housing ports may be opened at the same time exposing said pocket film covers, wherein select indexed pockets may be exposed for different periods of time “

t”

, or different gut positions “

x” and

upon individual commands each may be independently sealed and preserved for in vitro sampling, testing and analysis. One example for such a test being to determine the process by which autoimmune system toxins are produced, and to test a hypothesis that such toxins may be produced by cascaded events involving different species or strains of microbes processing different microbe byproducts, as an explanation for Celiac, gluten, or other protein, or other food product sensitivities.

II-4. II-4. As in claim II-3, wherein said pocket covering film degradation may be sensed by various means, and said signals are monitored/stored/transmitted by telemetry for purposes of experiment decision making.

II-5. II-5. As in claim II-3, wherein in addition to in vitro-analysis of in vivo-data and evidence, in vivo measurements are also simultaneously and continuously made within belt 3, recorded and transmitted to further correlate with said in vitro data analysis, as well as, correlate with extra body symptoms, observations and measurements, including, but not limited to, “

stomach growling”

, bloating, acid reflux, diarrhea, dizziness, and dozens of other well documented symptoms associated with the complex food digestion and nutrient absorption processes.

II-6. II-6. As in claims II-1, II-2 and II-4, wherein said film on pocket may be dissolved or ruptured by various means to expose cells-on-a-chip to gut fluids and microbes at some point of interest x, such as jejunum villi and micro-villi, to discover, identify, and locate sources, processes of creation, and chemical composition of toxins as may be first detected by cells-on-a-chip, and with further intimate chip contact actually identify and classify the toxin or its toxicity, and in the process, for example, discover the cause of such diseases as Celiac, or gluten, or other protein sensitivities of the autoimmune system. Said cells-on-the-chip may furthermore be the subject patient'"'"'s own cells functioning as a sensor/transducer and the toxin substance and associated microbes captured/sampled.

III. III. Capsule B embodiments as a system constitutes a method and apparatus-based platform station from which a plurality of applications can be used to conduct a plethora of data gathering means, tests, analyses, diagnoses, and data reduction/interpretations to analyze the gastrointestinal tract processes and functions, and help diagnose its malfunctions.

III-1. III-1. As in claim III, wherein control of belt 3 position within Capsule B constitutes also a repositioning process capability that can be used for orienting the transmitting antenna for optimal extra body signal strength reception.

III-2. III-2. As in claim III, wherein various components may be made of FDA approved substances for use in biomedical applications, especially as manufactured by using 3-D or 4-D printing, and bio-nano-materials, and in addition, said construction materials may be made from regular food products normally consumed and digested by humans.

III-3. III-3. As in claim III, wherein measurements made within belt 3 pocket instruments may trigger alerts for decision making in general, or automated responses in an interactive manner.

III-4. III-4. As in claim III, wherein sensors in said belt pockets may be of a biosensor type, that incorporates biomaterials, microbes or hybrid sensors/transducers such as organs-on-a-chip.

III-5. III-5. As in claim III, wherein human safe substances deposited in belt 3 pockets and connected by one or more electrodes, including to the capsule exterior housing, create sufficient low-voltage potentials to constitute an in vivo battery of sufficient energy to power low-power requirement chips or other electronic/bio-electronic devices.

III-6. III-6. As in claim III, wherein some instrumentation contained within belt 3 pockets require sufficient low voltage and low energy levels to derive their power requirements from telemeter sources, or combined gut capsule and exterior body skin electrodes and applied potentials

III-7. III-7. As in claim III, wherein a new method of gut analysis, representation and modeling is created with embodiments of constructing numerical polynomial functions from a plurality of experimental data variables obtained from measurements of belt collected samples from Capsules A and B, as “

Distribution Functions”

of

     1) gut length,

     2) each other,

     3) calculated variables, or

     4) other data sets. Likewise, said Distribution Functions can be created for a plurality of dependent variables as available from future data bases, such as, healthy or unhealthy, diseased, or other variables and correlated as a means of determining the sources of illnesses and diseases.

III-8. III-8. As in claim III, wherein an in vivo tool provides for interactive biofeedback measurements of biochemical, bioelectric, muscular or other means, for example, autoimmune or brain responses to an in vivo perturbation of various means from within, or origin from, a belt pocket, and the immediate response is measured from another belt pocket.

III-9. III-9. As in claim III, wherein Capsule B is used as a research tool to explore, prove/disprove concepts and hypotheses pertaining to the digestion process, and create data that provides for detailed distribution functions that individually or in totality depict and characterize the digestion process for any specific food introduced at any point within the GI tract.

III-10. III-10. As in claim III, wherein as a research data mining tool, it emulates the gut and its contents characteristics in a sense to capture more infinitesimal-like, large-volume data sets of various gut properties “

as is” and

“

as perturbed”

, and some pockets within said belt system contain lab-in-a-chip based sensors for a multiplicity of variables and phenomena, and adjacent belt pockets contain huge data set storage provisions of the order of gigabytes.