Systems and methods for intra-oral drug delivery

• US 8,439,674 B2
• Filed: 12/13/2011
• Issued: 05/14/2013
• Est. Priority Date: 11/30/2004
• Status: Active Grant

• Current Assignee: Align Technology Incorporated
• Original Assignee: Align Technology Incorporated
• Inventors: Li, Chunhua, Carlyle, Wenda C., De Smedt, Philippe, Abolfathi, Amir, Kuo, Eric E., Tricca, Robert E., Chen, Jennifer C., Wu, Benjamin M.
• Primary Examiner(s): PATEL, YOGESH P
• Application Number:
  US13/324,882
• Publication Number:
  US 20120082950A1
• Time in Patent Office: 518 Days
• Field of Search: 433/80, 433 88- 9, 433/24, 433/6, 433215- 8, 128859-862, 424/422, 424/435, 604/94.01, 604/187, 604/264, 601162-165
• US Class Current: 433/24
• CPC Class Codes: A61C 19/063 Medicament applicators for teeth or gums, e.g. treatment with fluorides
• CPC Class Codes: A61C 7/00 Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
• CPC Class Codes: A61C 7/008 using vibrating means
• CPC Class Codes: A61C 7/08 Mouthpiece-type retainers or positioners, e.g. for both the lower and upper arch arch-shaped medicament applicators for teeth or gums A61C19/063; mouthguards for protecting the teeth of sportsmen A63B71/085
• CPC Class Codes: A61C 8/00 Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools fastening of peg-teeth in the mouth A61C13/30
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Systems and methods are disclosed for intra-oral delivery of drugs.

Claims

1. A device for delivering one or more substances, comprising:

a dental device comprising a shell formed of a material and the dental device configured to move a number of teeth and including one or more reservoirs formed in the shell;

at least one of the reservoirs supplied with the one or more substances; and

a nozzle formed of the material as a portion of the shell and connected to the at least one reservoir and configured to be inserted into a gum of a patient to fluidly release the one or more substances from at least one reservoir at a first preselected dose at a first predetermined time period and to fluidly release the one or more substances from at least one reservoir at a second preselected dose at a second predetermined time period, wherein the nozzle is shaped to conform to the gum for prolonged placement therein.

2. The device of claim 1, wherein the one or more substances include a therapeutically effective amount of a drug or a bioactive agent.

3. The device of claim 1, wherein the one or more substances provide one or more results selected from the group of results including:

accelerating tooth movement;

decelerating tooth movement;

accelerating tooth movement by degrading collagen in the oral tissue;

accelerating tooth movement by degrading elastin in the oral tissue;

accelerating tooth movement by increasing the expression of endogenous enzymes that degrade collagen;

accelerating tooth movement by increasing the expression of endogenous enzymes that degrade elastin;

accelerating tooth movement by increasing the activity of endogenous enzymes that degrade collagen;

accelerating tooth movement by increasing the activity of endogenous enzymes that degrade elastin;

accelerating tooth movement by causing degradation of glycosaminoglycans or proteoglycans;

inducing irritation of the oral structure;

inducing inflammation of a bone structure;

inducing inflammation of surrounding tissue;

inducing inflammation of a bone structure or surrounding tissue by increasing the local concentration of interleukin-1, interleukin-6, tumor necrosis factor-alpha, or transforming growth factor-beta;

relieving oral pain involved with dental movement;

relieving pain from alveolar ridge augmentation and orthognathic treatment;

providing fresh breath;

altering tooth movement by stimulating bone resorption;

altering tooth movement by reducing bone resorption; and

preventing tooth relapse by causing an increase in the number of crosslinks between tissue matrix proteins in the oral environment.

4. The device of claim 1, further configured to deliver one of the one or more substances to a specific location within the gum and to deliver a different one of the one or more substances to a different location within the gum.

5. The device of claim 1, further comprising a supply of energy thereto.

6. The device of claim 1, wherein the energy comprises electric, light, heat, sound, magnetic or electromagnetic energy.

7. The device of claim 1, wherein the device is configured to fluidly release the one or more substances without active physical manipulation of the at least one reservoir.

8. The device of claim 1, wherein the device is designed from scans of the patient'"'"'s dentition.

9. The device of claim 1, wherein the device is designed to dispense the one or more substances in a predetermined sequence.

10. The device of claim 1, wherein the device is designed to dispense the substance in two or more different preselected dosages for delivery at two or more different predetermined periods.

11. The device of claim 1, further configured to sample an intra-oral substance in the patient'"'"'s mouth, whether the intra-oral substance has been delivered to or is already present in the mouth;

and diagnose a body condition based on a result of the intra-oral substance sample.

12. The device of claim 11, wherein the body condition comprises a disease.

13. The device of claim 11, further configured to perform a close-loop delivery of the substance within the mouth based on the result of the intra-oral substance sample.

14. The device of claim 11, further configured to transmit the result of the intra-oral substance sample to a remote computer for diagnosis.

15. The device of claim 1, wherein at least one of the one or more substances contains at least one of the following active ingredients:

trypsin;

elastase;

papain;

aminobenzoate potassium;

cathepsin;

amylolytic enzyme;

proteolytic enzyme;

celluloytic enzyme;

lipase;

prostaglandin E2;

prostaglandin F2alpha;

heparin;

relaxin;

conconavalen A;

nicotine;

hyaluronidase;

alpha-L-iduronidase;

catabolin;

estradiol;

genipin;

carbodiimide;

glutaraldehyde;

formaldehyde;

1,6-diaminohexane;

bioflavonoids;

or reducing sugars including glucose, ribose, or derivatives thereof.

16. The device of claim 1, wherein at least one of the one or more substances alters tooth movement by stimulating or reducing bone resorption.

17. The device of claim 1, wherein at least one of the one or more substances contains a bisphosphonate.

18. The device of claim 1, wherein a first reservoir of the one or more reservoirs is supplied with a first substance of the one or more substances and a second reservoir of the one or more reservoirs is supplied with a second substance of the one or more substances.

19. The device of claim 18, wherein the first substance is different from the second substance.

20. The device of claim 18, wherein the first substance is the same as the second substance.

21. The device of claim 18, wherein a third reservoir of the one or more reservoirs is supplied with a third substance of the one or more substances, wherein the first and third substances are different from the second substance.

22. The device of claim 1, wherein one of the one or more substances comprises analgesics.

23. The device of claim 1, wherein the nozzle is configured to be inserted into the gum on a lingual side of the number of teeth.

24. The device of claim 1, wherein the nozzle is configured to be inserted into the gum on a frontal side of the number of teeth.

25. The device of claim 24, wherein the dental device includes a second nozzle configured to be inserted into the gum on a lingual side of the number of teeth.

26. The device of claim 1, wherein a dispensing mechanism of the nozzle is chemically activated.

27. The device of claim 1, wherein a dispensing mechanism of the nozzle is electronically activated.

28. The device of claim 1, wherein the dental device includes a processor thereon for controlling a dispensing mechanism of the nozzle.

29. A system for delivering one or more substances, comprising:

a plurality of appliances, comprising shells formed of a material, configured to move a number of teeth of a patient, wherein at least one of the appliances includes;

a reservoir formed in the shell; and

a nozzle formed of the material as a portion of the shell, connected to the reservoir, and configured to be inserted into a gum of the patient to fluidly release a substance from the reservoir at a first preselected dose at a first predetermined time period and to fluidly release the substances from the reservoir at a second preselected dose at a second predetermined time period, wherein the nozzle is shaped to conform to the gum for prolonged placement therein.

30. The system of claim 29, wherein the plurality of appliances are designed from scans of the patient'"'"'s dentition.

31. The system of claim 30, wherein at least one of the plurality of appliances is designed to dispense a plurality of substances in a predetermined sequence.

32. The system of claim 30, wherein two or more of the plurality of appliances are designed to dispense the substance in two or more different preselected dosages for delivery at two or more different predetermined periods.

33. The system of claim 29, wherein the reservoir is supplied with the substance.

34. The system of claim 29, wherein the nozzle is configured to be inserted into the gum on a lingual side of the number of teeth.

35. The system of claim 29, wherein the nozzle is configured to be inserted into the gum on a frontal side of the number of teeth.

36. The system of claim 35, wherein the at least one of the appliances includes a second nozzle configured to be inserted into the gum on a lingual side of the number of teeth.

37. The system of claim 29, wherein a dispensing mechanism of the nozzle is chemically activated.

38. The system of claim 29, wherein a dispensing mechanism of the nozzle is electronically activated.

39. The system of claim 29, wherein the at least one appliance includes a processor thereon for controlling a dispensing mechanism of the nozzle.

40. The system of claim 39, wherein the processor is configured to control the dispensing mechanism of the nozzle in a close-loop manner.

41. The system of claim 29, wherein the shell includes a cavity shaped to be removably placeable over a number of teeth.