ELECTRONIC CAPSULE FOR TREATING GASTROINTESTINAL DISEASE

• US 20090275923A1
• Filed: 04/11/2007
• Published: 11/05/2009
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Shimizu, Jeff, Trovato, Karen I.
• Granted Patent: US 8,147,482 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/06 Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia

Abstract

The present invention discloses an ingestible capsule containing drug and a method for controlled administration of the drug in a mammal for treatment of a disease of the GI tract. The capsule has electronic control means for dispensing the drug substantially to the diseased tissue sites of the GI tract, according to a pre-determined drug release profile obtained prior to administration from the specific mammal.

Claims

1. An ingestible capsule for administering a drug for the treatment of a disease in the gastrointestinal tract of a mammal according to a pre-determined drug release profile, the gastrointestinal tract having sites of diseased tissue and normal tissue, the capsule comprising:

a drug reservoir for storing the drug;

drug dispensing means for dispensing or stopping the dispensing of the drug from the drug reservoir into the gastrointestinal tract;

electronic control circuitry means communicating with the drug dispensing means for regulating the amount and time interval for dispensing of the drug into the gastrointestinal tract by the drug dispensing means according to the predetermined drug release profile, wherein the electronic control circuitry means further comprises memory means for storage or updating of data specific to the pre-determined drug release profile for the mammal; and

a non-digestible outer protective shell housing the drug reservoir, drug dispensing means and electronic control circuitry means;

wherein the drug is substantially dispensed at the diseased tissue sites.

2. The capsule of claim 1 further comprising sensor means within the capsule for sensing one or more biological conditions in the gastrointestinal tract;

wherein the sensor means communicates with the electronic control circuitry means for activating the control circuitry means to dispense drug according to the drug release profile, or to determine or modify the drug release profile.

3. The capsule of claim 2 wherein the biological condition sensed by the sensor means is selected from the group consisting of pH level, presence or absence of bacteria or enzymes, and the presence or absence of blood.

4. The capsule of claim 1 further comprising a wireless communication means for transmitting and/or receiving signals to and from a second communications means located exterior to the body of the mammal;

wherein upon receiving a signal from the second communications means, the wireless communication means communicates with the electronic control circuitry means to activate the control circuitry means to dispense drug according to the drug release profile.

5. The capsule of claim 1 wherein the disease is selected from the group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

6. The capsule of claim 1 wherein the disease is Crohn'"'"'s Disease or Ulcerative Colitis and the drug is selected from the group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant drugs, immunomodulators, probiotics and antibiotics.

7. A method for administration of a drug for the treatment of a disease in the gastrointestinal tract of a mammal according to a pre-determined drug release profile, the gastrointestinal tract having sites of diseased tissue and normal tissue, the method comprising:

orally administering to the mammal an ingestible capsule that includes the drug;

dispensing the drug in the gastrointestinal tract according to a predetermined drug release profile, wherein the drug is substantially dispensed at the diseased tissue sites;

wherein the capsule comprises;

a drug reservoir for storing the drug;

drug dispensing means for dispensing or stopping the dispensing of the drug from the drug reservoir into the gastrointestinal tract;

electronic control circuitry means communicating with the drug dispensing means for regulating the amount and time interval for dispensing of the drug into the gastrointestinal tract by the drug dispensing means according to the predetermined drug release profile, wherein the electronic control circuitry means further comprises memory means for storage or updating of data specific to the pre-determined drug release profile for the mammal; and

a non-digestible outer protective shell housing the drug reservoir, drug dispensing means and electronic control circuitry means.

8. The method of claim 7 wherein the capsule further comprises sensor means within the capsule for sensing one or more biological conditions in the gastrointestinal tract;

wherein the sensor means communicates with the electronic control circuitry means for activating the control circuitry means to dispense drug according to the drug release profile, or to determine or modify the drug release profile.

9. The method of claim 8 wherein the biological condition sensed by the sensor means is selected from the group consisting of pH level, presence or absence of bacteria or enzymes, and the presence or absence of blood.

10. The method of claim 7 further comprising a wireless communication means for transmitting and/or receiving signals to and from a second communications means located exterior to the body of the mammal;

wherein upon receiving a signal from the second communications means, the wireless communication means communicates with the electronic control circuitry means to activate the control circuitry means to dispense drug according to the drug release profile.

11. The method of claim 7 wherein the disease is selected from the group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

12. The method of claim 7 wherein the disease is Crohn'"'"'s Disease or Ulcerative Colitis and the drug is selected from the group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant drugs, immunomodulators, probiotics and antibiotics.