Gastrointestinal bioreactor

• US 20040213825A1
• Filed: 04/24/2003
• Published: 10/28/2004
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Mark M Levy
• Original Assignee: Mark M Levy
• Inventors: Levy, Mark M.
• Granted Patent: US 7,611,480 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0014 removed from the body
• CPC Class Codes: A61M 2202/0057 retained by adsorption
• CPC Class Codes: A61M 2202/0064 changed by biological action
• CPC Class Codes: A61M 2202/0445 Proteins immunoglobulin A61M2202/0417; beta-2-microglobulin A61M2202/0421; thrombin A61M2202/0425; haemoglobin A61M2202/0433
• CPC Class Codes: A61M 2202/20 Pathogenic agents
• CPC Class Codes: A61M 2210/1042 Alimentary tract A61M2210/0618 takes precedence

Abstract

An in-vivo bioreactor device producing a dialysis effect by acting within the gastrointestinal tract for the removal of undesirable concentrated intestinal or blood substances or metabolites is disclosed. The ingestible device is comprised of a body wall that surrounds an internal compartment. Along the wall of the shell are openings located around the periphery that allow bodily fluids to enter and exit device. The wall of the device is comprised in whole or at least in part of materials that are impermeable to the passage of external fluids and maintains its physical and chemical integrity in the environment of use during its activity. Semi-permeable membranes located either internally or externally of the device are able to withstand all physiological temperatures and pH and act in a similar manner to dialysis membranes that are used for the separation of substances in suspensions, solutions, tissue cultures, etc. Treatment materials, including fixing agents that act in a similar manner to ion exchange resins, biologically active agents including proteins, enzymes, or live bacteria, and medicinal agents, can be placed in the internal cavity of the device for the treatment of various conditions.

Claims

1. An in-vivo bioreactor device comprising:

a swallowable, at least partly non-digestible housing having an external shell and defining at least one internal cavity,

at least one membrane provided relative to the at least one internal cavity to selectively allow predetermined constituents of a fluid to pass therethrough while retaining other fluidic constituents;

wherein

predetermined constituents in the gastrointestinal tract are retained in association with the at least one membrane to selectively remove said constituents upon introduction of the device into the gastrointestinal tract.

2. The device of claim 1, further comprising at least one treatment material within the at least one internal cavity, the treatment material selectively treating predetermined constituents within the at least one cavity and the at least one membrane enabling the passage of predetermined fluidic constituents out of the at least one cavity.

3. The device of claim 1, wherein the at least one membrane is provided by the housing material, having characteristics to allow passage of predetermined fluidic constituents while filtering other constituents.

4. The device of claim 1, wherein the at least one membrane is provided by a separate membrane material positioned relative to the housing to allow passage of a fluid therethrough.

5. The device of claim 1, wherein the at least one membrane filters materials selected from the group consisting of toxins, creatine, uric acid, hepatic toxic metabolites, alcohol metabolites, electrolytes, therapeutic or medicinal agents, detergents, renal metabolites, poisonous substances and heavy metals or combinations thereof from gastrointestinal fluids, and blood located within the gastrointestinal tract.

6. The device of claim 1, further comprising a pump to cause gastrointestinal fluids to pass through the at least one membrane.

7. The device of claim 1, wherein the treatment material binds certain materials therewith, so as to remove the materials from the body upon expulsion of the device from the body.

8. The device of claim 1, wherein the treatment materials are selected from the group consisting of binding agents, ion-exchange resins, charcoal, hyaluronic acid, natural extracts synthetic or natural gels or combinations thereof.

9. The device of claim 1, wherein the treatment materials are materials that convert predetermined substances to a less toxic or a less active configuration.

10. The device of claim 9, wherein the treatment materials are selected from the group consisting of proteins, enzymes, live bacteria or combinations thereof, and converted substances pass through the device and are returned to the gastrointestinal tract.

11. The device of claim 1, wherein the at least one internal cavity houses a pump to process gastrointestinal fluids and expel the processed fluids back to the gastrointestinal tract actively or passively through a valve or a membrane located within the at least one internal cavity.

12. The device of claim 1, wherein the housing has a variable dimension.

13. The device of claim 1, wherein the device further comprises a marker for identifying the device in the body using non-invasive imaging processes.

14. The device of claim 1, wherein the internal cavity is sectioned into at least two compartments.

15. A method of removing toxins from the gastrointestinal tract with an in-vivo bioreactor, the method comprising the steps of:

providing a swallowable, at least partly non-digestible housing having an external shell and defining at least one internal cavity, at least one membrane located relative to the at least one internal cavity to selectively allow predetermined fluidic constituents to pass therethrough while retaining other constituents,

ingesting at least one housing;

passing gastrointestinal fluids, blood, and metabolites located within the gastrointestinal tract through the housing and at least one membrane;

filtering toxins located within the gastrointestinal fluids and the blood or the metabolites through the membrane, wherein the toxins are retained in the membrane, whereby the toxins or metabolites are isolated from the gastrointestinal fluids or the blood; and

excreting the housing through natural ways using peristaltic motion of the gastrointestinal tract.

16. The method of claim 15, further comprising the step of providing at least one treatment material within the at least one internal cavity, the treatment material selectively treating the predetermined constituents within the at least one cavity and the at least one membrane enabling the passage of predetermined fluidic constituents out of the at least one cavity.

17. The method of claim 15, wherein more than one of the housings are ingested to increase the filtering of the toxins.

18. A method of biochemically processing materials located in the gastrointestinal tract with an in-vivo bioreactor, the method comprising the steps of:

providing a swallowable, at least partly non-digestible housing having an external shell and defining at least one internal cavity, at least one membrane provided relative to the at least one internal cavity to selectively allow predetermined constituents of a fluid to pass therethrough, and a treatment material within the at least one internal cavity, the treatment material selectively treating the predetermined constituents within the at least one cavity and the at least one membrane enabling the passage of predetermined fluidic constituents out of the at least one cavity;

ingesting at least one housing;

having gastrointestinal fluids, blood, and metabolites located within the gastrointestinal tract osmotically pass through the housing;

converting at least one toxic substance in said gastrointestinal fluids, blood, and metabolites to a less toxic and less active conformation by means of the treatment material;

enabling the return of at least one converted substance passage to the gastrointestinal tract; and

excreting the housing through natural ways using peristaltic motion of the gastrointestinal tract.

19. An in-vivo bioreactor device comprising:

a swallowable, at least partly non-digestible housing having an external shell and defining at least one internal cavity,

at least one membrane provided relative to the at least one internal cavity to selectively allow predetermined constituents of a fluid to pass therethrough; and

a treatment material within the at least one internal cavity, the treatment material selectively removing predetermined constituents from the fluids within the at least one cavity and the at least one membrane enabling the passage of predetermined fluidic constituents out of the at least one cavity.

20. An in-vivo bioreactor device comprising:

a swallowable, at least partly non-digestible housing having an external shell and defining at least one internal cavity, wherein the housing has at least one inlet opening and at least one outlet opening;

at least one membrane located relative to the at least one outlet opening, such that upon flow of fluids from the inlet to the outlet, the membrane will selectively filter predetermined constituents in the fluid.