Swallowable multi-nozzle dosing device for releasing medicines in the gastrointestinal tract

• US 8,597,279 B2
• Filed: 10/17/2007
• Issued: 12/03/2013
• Est. Priority Date: 10/31/2006
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Medimetrics Personalized Drug Delivery B.V.
• Inventors: Dijksman, Johan Frederik, Pierik, Anke, Rensen, Judith Margreet, Shimizu, Jeff, Zou, Hans, Schram, Ivar
• Primary Examiner(s): SHUMATE, VICTORIA PEARL
• Application Number:
  US12/447,808
• Publication Number:
  US 20100049120A1
• Time in Patent Office: 2,239 Days
• Field of Search: 604/66, 604/67, 604/890.1, 604/891.1, 424/451, 424/457
• US Class Current: 604/890.1
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A capsule and methodology for dispensing a medicament in the gastrointestinal tract of a mammal is disclosed, the gastrointestinal tract having tissue sites of interest. The capsule may include a medicament reservoir; medicament dispensing means such as a plurality of piezoelectric droplet jet nozzle dispensers; a power source; electronic control circuitry means and/or detecting means capable of communicating with a medicament dispensing means for regulating the amount and time interval for dispensing of the medicament into the gastrointestinal tract by the medicament dispensing means; and a non-digestible outer protective shell housing, e.g., the medicament reservoir, medicament dispensing means and electronic control circuitry means. A plurality of the nozzle dispensers of the medicament dispensing means can be positioned tangentially to a surface of the housing such that during release of a medicament, the capsule is caused to rotate and/or translate so as to discharge the medicament homogeneously onto tissue sites of interest. In addition, by using multiple nozzles and releasing medicament at high speed, this facilitates medicament absorption by the intestines in the gastrointestinal tract.

Claims

1. An ingestible capsule for dispensing a medicament at or near tissue sites of interest, the capsule comprising:

a sidewall;

a medicament reservoir for storing the medicament, disposed within the sidewall;

at least one piezoelectric droplet jet nozzle dispenser in fluid communication with the medicament reservoir, each at least one piezoelectric droplet jet nozzle dispenser including a nozzle arranged to eject medicament through the sidewall, along a dispensing axis angled at a non-zero angle relative to an axis normal the sidewall at the nozzle;

a controller communicating with the dispenser to control release of the medicament through the nozzle; and

a power source for providing power to one or more components of the capsule.

2. The capsule of claim 1, further comprising a sensor adapted to sense one or more biological conditions;

wherein the sensor cooperates with the controller to selectively dispense the medicament according to the medicament release profile, and/or to determine and/or modify such medicament release profile.

3. The capsule of claim 2, wherein the biological condition sensed by the sensor is selected from a group consisting of pH level, presence or absence of bacteria or enzymes, anatomical location at or ncar the tissue site of interest, and the presence or absence of blood.

4. The capsule of claim 1, further comprising a wireless communicator adapted to transmit signals to and/or receive signals from a remote communicator, wherein when the wireless communicator is adapted to receive signals, upon receiving a signal from the remote communicator, the wireless communicator cooperates with the controller so as to modify and/or dispense the medicament according to the medicament release profile.

5. The capsule of claim 1, wherein the capsule is used to administer a medicament intended to treat a disease seiected from a group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

6. The capsule of claim 1, wherein the capsule is used to administer a medicament intended to treat Crohn'"'"'s Disease or Ulcerative Colitis and the medicament is selected from a group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant medicaments, immunomodulators, probiotics and antibiotics.

7. The capsule of claim 1, wherein the capsule has a housing that is manufactured from at least one material selected from a group consisting of PELLETHANE 2363 polyetherurethane series of materials, ELASTHANE polyethemrethane, PURSIL thermoplastic silicone polyether urethane, and CARBOSIL silicone polycarbonate urethane.

8. The capsule of claim 1, further comprising a sensor adapted to sense rotation of the capsule.

9. The capsule of claim 1, wherein the controller comprises a real-time clock to provide a reference for elapsed traveling time of the capsule within the gastrointestinal tract.

10. The capsule of claim 1, wherein ejection of medicament along the dispensing axis causes the capsule to rotate, thereby discharging the medicament homogeneously onto the tissue sites of interest.

11. A method for dispensing a medicament in the gastrointestinal tract of a mammal, the gastrointestinal tract having tissue sites of interest, the method comprising:

orally administering an ingestible capsule accommodating the medicament, the capsule comprising a sidewall;

a medicament reservoir within the sidewall storing a medicament; and

at least one piezoelectric droplet jet nozzle dispenser including a nozzle arranged to eject medicament through the sidewall, along a dispensing axis angled, at a non-zero angle, relative to an axis normal the sidewall at the nozzle; and

rotating the capsule proximate the tissue site of interest by ejecting the medicament along the dispensing axis according to a medicament release profile.

12. The method of claim 11, further comprising sensing one or more biological conditions in the gastrointestinal tract, and based on the sensing step, dispensing the medicament according to the medicament release profile, and/or determining or modifying the medicament release profile.

13. The method of claim 12, wherein the biological condition sensed in the sensing step is selected from a group consisting of pH level, presence or absence of bacteria or enzymes, anatomical location in the gastrointestinal tract and the presence or absence of blood.

14. The method of claim 11, wherein the capsule has first wireless communication means for receiving signals from a second wireless communication means, and further comprising, upon receipt of a signal from the second communications means, dispensing the medicament according to the medicament release profile.

15. The method of claim 11, wherein the method is employed to administer a medicament for the treatment of a disease selected from a group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

16. The method of claim 11, wherein the method is employed to administer a medicament for the treatment of Crohn'"'"'s Disease or Ulcerative Colitis and the medicament is selected from a group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant medicaments, immunomodulators, probiotics and antibiotics.

17. The method of claim 11, wherein the capsule has a housing that is manufactured from at least one material selected from a group consisting of PELLETHANE 2363 polyethcrurethane series of materials, ELASTHANE polyetherurcthane, PURSIL thermoplastic silicone polyether urethane, and CARBOSIL silicone polycarbonate urethane.

18. The method of claim 11, further comprising sensing when the capsule has rotated a defined amount and-stopping dispensing of the medicament.

19. The method of claim 11, wherein the control means includes a real-time clock to provide a reference for elapsed traveling time of the capsule.

20. The method of claim 11, wherein one or more of the nozzle dispensers are positioned tangentially to the surface of a housing to the capsule such that during discharge of the medicament, the capsule is caused to rotate and/or translate so as to discharge the medicament homogeneously onto one or more tissue sites of interest.

21. A capsule comprising:

a reservoir for storing a medicament; and

at least one piezoelectric droplet jet nozzle dispenser in fluid communication with the medicament reservoir, each at least one piezoelectric droplet jet nozzle dispenser including a nozzle arranged to eject medicament through a sidewall of the capsule along a dispensing axis angled, at a non-zero angle, relative to an axis normal the sidewall at the nozzle, wherein the medicament is retained by one or more micelles so as to be dispensable in accordance with a medicament release profile.

22. The capsule of claim 21, wherein the micelles aid in the absorption of medicament at one or more tissue sites of interest.

23. A capsule comprising:

a reservoir for storing one or more medicaments;

at least one piezoelectric droplet jet nozzle dispenser in fluid communication with the medicament reservoir, each at least one piezoelectric droplet jet nozzle dispenser including a nozzle arranged to eject medicament through a sidewall of the capsule along a dispensing axis angled, at a non-zero angle, relative to an axis normal the sidewall at the nozzle; and

a pressure sensor for detecting contraction pressure associated with at least one peristaltic contraction, wherein one or more medicaments are retained via said capsule so as to be dispensed in response to detection of one or more peristaltic contractions.