Patient In Vivo Gut Diagnostic and Treatment Tool

• US 20140162305A1
• Filed: 06/28/2013
• Published: 06/12/2014
• Est. Priority Date: 11/30/2012
• Status: Active Grant

• Current Assignee: Shuck, L. Zane
• Original Assignee: Shuck, L. Zane
• Inventors: Shuck, L. Zane
• Granted Patent: US 8,926,526 B2
• Time in Patent Office: Days
• US Class Current: 435/29
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: G01N 33/5091 for testing the pathological state of an organism

Abstract

An orally ingestible capsule device with monitoring and control instruments is provided for practicing physicians to use in patient examining rooms. The Capsule is part of an in vivo gut healthcare system with capabilities of delivering medications to any point in the gut, administering them at any time, or autonomously based upon onboard measurements, and simultaneously measuring results, along with extra body function measurements. It is capable of delivering gut medications or autoimmune perturbation substances and simultaneously measuring responses and sample gut substances/microbes at application points. Objectives, as part of patient diagnosis, include determining microbe roles in the patient'"'"'s digestion process, along with toxic substances contributing to illnesses or diseases, such as gluten sensitivities. Capsule embodiments include a belt with pockets for substance delivery or sampling, lab-on-a-chip devices, chip-based logic, sensor/transducer, and control circuits, and data reduction and storage, for efficient, cost-effective diagnostics and treatment in minimal time.

Claims

I. I. An orally ingested capsule is invented and designed to be user friendly specifically by medical personnel to quickly and efficiently diagnose patients with illnesses or diseases of the gut, wherein said capsule is comprised of actuator articulated belts and indexed pockets with onboard autonomous and telemeter controlled circuitry that can administer medication, and sample gut matter or measure gut system responses prior to, during, and after said medication or a system perturbation substance is delivered to the gut. Focus in this configuration is upon the gut contents matter and its consequential impact.

I-1. I-1. As in claim I, wherein said capsule is comprised of multiple belts, each with a plurality of pockets of different design shapes and sizes to meet requirements and provide flexibility in obtaining samples of suitable quantity or other quality and preserved suitable for in vitro conventional laboratory analyses for both biochemical substances and microbial content, wherein as one further objective is to provide quick, simple, and inexpensive diagnostic patient care as possible.

I-2. I-2. As in claim I-1, wherein said sampling and medication operations are individually controlled by remote telemetry, and can be executed at any time “

t”

or any location “

x”

along the GI tract, and time intervals for performed operations are optional.

I-3. I-3. As in claim I through I-2, wherein one configuration of belt-pocket systems includes three side-by-side belt-pocket systems, with the center belt-pockets containing medications or perturbation substances, and the two outside belt-pockets straddling the center one contain a variety of sensors to monitor gut fluid properties or body regional in vivo environment variables of interest as pertain to the specific medical procedure, including any variables as may be affected by said particular medication/substance delivery, and said two monitoring belts with pocket sensors are positioned on each side (upstream and downstream) of medications/substance carrying belt and pocket system. One or more of these pockets may contain chip-based sensors/transducers, data reduction and logic circuits, and cells-on-a-chip sensors/transducers. This configuration system is designed for particular medical logistical procedures, such as a body system perturbation to provoke body reaction responses, wherein “

reactive”

variables are measured, and all components are specifically sized and configured for these special purposes, and extra body functions and variables are also simultaneously measured for a wide variety of reasons.

I-4. I-4. As in claim I-3, wherein instead of the two sensors belt-pocket systems straddling said medication/substance delivery belt-pocket system, two conventional belt-pocket matter sampling and preserving means belts, as in Invention I Capsule A, straddle the medication/substance delivery belt-pocket system, one upstream and one downstream. This configuration system is designed for particular medical logistical procedures, and optional autonomous or remote interactive substance delivery, largely involving microbial implication examinations, and all components are specifically sized and configured for these special purposes, and a variety of interchangeable cards are available for physician choices.

I-5. I-5. As in claim 1-3, wherein one of the two belt-pocket systems straddling said center medication/substance delivery belt-pocket system, is a conventional belt-pocket matter sampling and preserving means, as in Invention I Capsule A, and the other straddling belt-pocket system positioned on the other side of center belt contains sensors. One or more of these pockets may contain chip-based sensors/transducers, data reduction and logic circuits, and cells-on-a-chip sensors/transducers. This configuration system is designed for particular medical logistical procedures, and optional autonomous or remote interactive substance delivery, largely involving microbial implication examinations, and all components are specifically sized and configured for these special purposes, and a variety of interchangeable cards are available for physician choices.

I-6. I-6. As in claim I, wherein one or more components of ingested Capsules A, B, or C may be fabricated from normal food products, and/or FDA approved products for biomedical applications as available for 3-D or 4-D printers.

I-7. I-7. As in claims I-3 and I-5, wherein said instrumentation pockets may contain onboard chip-based data processing, reduction, and conversion, or logic circuits for expediting telemetry operations or onboard decision making.

I-8. I-8. As in claim I, wherein a physician in the interest of quickly and inexpensively getting to a conclusion or decision point for an ill patient, can prescribe a specific belt/pocket configuration for deployment at a specific point x, perhaps including medication provisions, and collect samples or administer medication, or a perturbation, as a means of forming a basis of comparison to a particular healthy human gut profile or some distribution function of a plurality of variables, either as a diagnostic or a treatment procedure.

I-9. I-9. As in claim I, wherein a prescribed configuration of Capsule components and contents is administered, in general and with protocols based upon a gut distribution function of a variety of variables, as may have been generated from some research data base, or the subject patient being treated.

II. II. A separate off-the-shelf belt and pocket system with various combinations of embodiments of claim I, except, all features of this system are differently focused and configured with different features to achieve specific “

gut system perturbation responses”

pertaining to specific gut anatomy. The strategy and methodology herein embodied is to test the patient for sensitivities, autoimmune, or other physical, chemical, biochemical, or other means of reactions by subjecting some chosen anatomical parts or regions of the gut to some specific perturbing or provoking substance or microbe, and measure responses using onboard sensors. The focus of these configurations is the gut itself as opposed to the content matter. This in vivo procedure is somewhat analogous to simpler and older in vitro methods of using scratch or skin tests to determine food, or other substance allergies.

II-1. II-1. As in claim II, wherein the substance delivery pockets may be larger in number and contain smaller quantities to test at low dosage levels, and a few pockets of larger size to contain larger quantities of same or different substances, and in some configurations, said belt passes over a guide idler roller bearing that pushes the belt against the selected and aligned housing port and in the process ruptures a very thin substance containing/confining film membrane covering said pockets, and thereby extrudes significant quantities of said substances into the precise desired section “

x”

of the gut, and above provisions of either sampling or monitoring as apriori selected are implemented.

II-2. II-2. As in any of claims I or II, belts and pockets are co-designed by multi and interdisciplinary medical personnel and physicians ranging from neurologists, endocrinologists and allergists to microbiologists and may be so filled, situated, and indexed so that iterative or repetitive tests or treatments may be conducted using stepping or reversible micro-motors for either, repeatability-verification, required larger volumes, dosages, or concentrations of medications to achieve results, or other purposes as physicians may prescribe germane to their field of specialization.

II-3. II-3. As in all of claims I and claims II-1 and II-2, wherein one to many of a patient'"'"'s prior determined distribution functions (DF) as measured by Capsules B or C, are stored on a chip, or lab-on-a-chip, and incorporated in logic circuits for triggering, subject to some parameter value within the specific DF being met to actuate some diagnostic or treatment procedure, thereby automating the process.

III. III. The capabilities and flexibilities introduced by these aforesaid belt and pocket systems are most effectively carried out within a framework of a rigid-body housing structure for precision and low-tolerance control purposes. However, some applications may require other versions of Capsule C in particular, for medication delivery, especially to smaller animals and younger humans. Other considerations are therefore given to capsule housing and internal structural components, such as, flexibility, collapsibility, inflate ability, dilatability, dissolvability, digestibility, and what the achievable limits are, based upon today'"'"'s peripheral technologies, of which are currently limited mostly by motor sizes of about 6 mm diameter. Constraints imposing such necessary considerations for more diverse applications of capsules include such things as convoluted folds and sharp bends of small and large intestines in smaller animals. Thus, other manifestations of said capsule designed features, although typically with less precision, include providing many other off-the-shelf versions of said capsules to be responsive to physician needs as part of a comprehensive gut in vivo healthcare delivery system.

III-1. III-1. As in claim III, wherein many of the structural components of Capsule C may be thin, inflated, flexible membranes and tubing with total capsule system integrated structural engineering designs, and of a diversity of dissolvable substances, some members may be inflated and pressurized with liquids or gasses prior to ingestion, and some members or pockets may be in vivo inflatable for storage of, and using, sampled gut fluids, and wherein said capabilities may be used as part of the sampling or delivery missions, or for safety and retrieval means.

III-2. III-2. As in claim III-1, wherein said designs and capabilities may be used for capsule stability during performance of prescribed functions.