Electronic capsule for treating gastrointestinal disease

• US 8,147,482 B2
• Filed: 04/11/2007
• Issued: 04/03/2012
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Medimetrics Personalized Drug Delivery B.V.
• Inventors: Shimizu, Jeff, Trovato, Karen I.
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): THOMAS, JR, BRADLEY G
• Application Number:
  US12/305,118
• Publication Number:
  US 20090275923A1
• Time in Patent Office: 1,819 Days
• Field of Search: 604/890.1, 604/891.1, 604/67, 600/118, 600/424, 600/348, 600/368, 424/452, 424/451
• US Class Current: 604/891.1
• 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 treatment of a disease in a 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;

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

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

at least one sensor configured to communicate with the electronic control circuitry; and

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

wherein the drug is substantially dispensed at the diseased tissue sites by the electronic control circuitry activating the drug dispensing device in response to detection of a biological condition by the at least one sensor,

wherein the at least one sensor is a threshold sensor that detects a level of the biological condition crossing a predetermined threshold, and

wherein the electronic control circuitry is configured to start a timer for the dispensing of the drug into the gastrointestinal tract in response to the level of the biological condition crossing the predetermined threshold.

2. The capsule of claim 1 wherein the at least one sensor is configured for sensing one or more biological conditions in the gastrointestinal tract;

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

3. The capsule of claim 1 wherein the biological condition sensed by the at least one sensor comprises a pH level.

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

wherein upon receiving a signal from the second communications device, the wireless communication device communicates with the electronic control circuitry device to activate the electronic control circuitry device 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.

13. The capsule of claim 1, wherein the biological condition sensed by the at least one sensor comprises a pH level, and the at least one sensor is a threshold sensor that detects the pH level crossing the predetermined threshold for starting the timer for the dispensing of the drug into the gastrointestinal tract.

14. The capsule of claim 13, wherein a rate of the dispensing of the drug is proportional to an amount the pH level that differs from the predetermined threshold.

15. The capsule of claim 1, wherein the biological condition sensed by the at least one sensor comprises presence or absence of bacteria or enzymes.

16. The capsule of claim 1, wherein the biological condition sensed by the at least one sensor comprises presence or absence of blood.

21. The capsule of claim 1, wherein the drug dispensing device includes a valve which is opened by the electronic control circuitry to dispense the drug from the drug reservoir into the gastrointestinal tract, and wherein the electronic control circuitry is configured to open the valve by a fixed amount for a first period of time to dispense the drug at a fixed rate, and to vary opening of the valve during a second period of time to dispense the drug at a variable rate.

7. A method for administration of a drug for treatment of a disease in a 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 the acts of:

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

detecting of a biological condition by at least one sensor included in the capsule, wherein the capsule further includes a drug dispensing device and a controller; and

in response to the detecting act, activating the drug dispensing device by the controller for 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 detecting act includes detecting a level of the biological condition crossing a predetermined threshold, and

wherein the activating act includes starting a timer for the dispensing of the drug into the gastrointestinal tract in response to the level of the biological condition crossing the predetermined threshold.

8. The method of claim 7 further comprising the act of communicating the sensed biological condition to the controller to dispense the drug according to the drug release profile, or to determine or modify the drug release profile.

9. The method of claim 7 wherein the biological condition sensed by the at least one sensor comprises a pH level.

10. The method of claim 7 further comprising wirelessly communicating signals between the capsule and an external device located exterior to the body of the mammal;

wherein the dispensing act is performed in response to a signal from the external device.

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.

17. The method of claim 7, wherein the biological condition sensed by the at least one sensor comprises a pH level, and the at least one sensor is a threshold sensor that detects the pH level crossing the predetermined threshold for starting the timer for the dispensing of the drug into the gastrointestinal tract.

18. The method of claim 17, further comprising the act of varying a rate of the dispensing of the drug in proportion to an amount the pH level that differs from the predetermined threshold.

19. The method of claim 7, wherein the biological condition sensed by the at least one sensor comprises presence or absence of bacteria or enzymes, or presence or absence of blood.

20. The method of claim 7, wherein the capsule further comprises a drug reservoir for storing the drug;

and

a non-digestible outer protective shell housing the drug reservoir, the drug dispensing device and the controller;

wherein the drug dispensing device is configured to dispense or stop the dispensing of the drug from the drug reservoir into the gastrointestinal tract;

wherein the controller is configured to communicate with the drug dispensing device for regulating amount and time interval for dispensing of the drug into the gastrointestinal tract by the drug dispensing device according to a predetermined drug release profile,

wherein the controller comprises a memory for storage or updating of data specific to the predetermined drug release profile for the mammal;

and wherein the at least one sensor is configured to detect the biological condition and communicate the detected biological condition to the controller for activating the drug dispensing device to dispense the drug in the gastrointestinal tract.

22. The method of claim 7, wherein the activating act includes opening a valve of the drug dispensing device by a fixed amount for a first period of time to dispense the drug at a fixed rate, and varying the opening of the valve during a second period of time to dispense the drug at a variable rate.