IP Library Granted Patent US 9,579,178
Granted Patent B2
US 9,579,178 · App. 13/940,940 · Granted Feb 28, 2017

Oral appliance for delivering a medicament

Inventor: Peter John Zegarelli (Sleepy Hollow, NY)
A61C19/066A61C19/063A61C19/08
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Quick Facts
Patent No.
US 9,579,178
App. No.
13/940,940
Granted
Feb 28, 2017
Kind
B2
Abstract

An oral appliance is provided for delivering a medicament to at least a portion of teeth and/or soft tissue areas inside a mouth, the oral appliance comprising an interior surface having a porous material disposed on at least a portion of the interior surface of the oral appliance, the porous material containing a medicament and the interior surface being formed to fit contours of at least the portion of the teeth and/or soft tissue areas inside the mouth and being capable of supporting and holding the porous material in contact with at least the portion of the teeth and/or soft tissue areas inside the mouth to deliver the medicament.

Claims (28)

1. An oral appliance for delivering a medicament to a portion of teeth and soft tissue areas inside a mouth, the oral appliance comprising an interior surface having a porous material disposed on a portion of the interior surface of the oral appliance, the porous material containing a medicament and the interior surface being formed to fit contours of the portion of the teeth and soft tissue areas inside the mouth and being capable of supporting and holding a contacting surface of the porous material in contact with the portion of the teeth and soft tissue areas inside the mouth to deliver the medicament, wherein the porous material is a single continuous piece configured to be supported and held within a cargo area, wherein the cargo area is continuous and configured to extend all around a gum line perimeter from a buccal area to a lingual area, the cargo area corresponding to a gum line, the cargo area including an internal space provided by an extension of an internal wall surface of the interior surface that is for holding and supporting the porous material, wherein the porous material in the cargo area is disposed between the gum line and the teeth, and the porous material retains the medicament in the gum line and the teeth.

2. An oral appliance according to claim 1 , wherein the porous material comprises a sponge or foam and the oral appliance is pre-filled with one or more doses of medicament and is disposable or reusable.

3. An oral appliance according to claim 2 , wherein the sponge or foam comprises a cushion zone.

4. An oral appliance according to claim 1 , wherein the interior surface is formed from a hard thermoplastic sheet material molded to correspond to the contours of the portion of the teeth and soft tissue areas inside the mouth up to and including muco-buccal folds, hard and soft palates, lining mucosa, attached gingival tissue, and/or mouth floor.

5. An oral appliance according to claim 1 , wherein the porous material corresponds to the contours of a portion of the teeth and soft tissue areas inside the mouth adjacent to buccal and lingual soft tissues.

6. An oral appliance according to claim 1 , wherein the porous material contacts one or more teeth and soft tissue areas inside the mouth and adjacent buccal and lingual soft tissues areas.

7. An oral appliance according to claim 1 , wherein the porous material and/or interior surface contacts the soft tissue and teeth at or near a gingival margin or sulcus.

8. An oral appliance according to claim 1 , wherein at least one of: (i) the porous material has a depth of from about 1 mm to about 5 mm; (ii) the porous material has a width of from about 1 mm to about 10 mm; or the oral appliance has a thickness of from about 0.06 inches to about 0.2 inches.

9. An oral appliance according to claim 1 , wherein the porous material and/or interior surface contacts the oral soft tissue and teeth and extends substantially the length of the gingival margin where the medicament is to be delivered.

10. An oral appliance according to claim 1 , wherein the porous material and/or interior surface contacts the oral soft tissue and extends to at least one of (i) a muco-gingival junction; (ii) at least 2 mm to 5 mm buccally beyond a gingival margin; or (iii) at least 2 mm to 5 mm lingually beyond a gingival margin.

11. An oral appliance according to claim 1 , wherein the porous material delivers at least one of (i) a bolus dose of the medicament; (ii) a single dose of the medicament; or (iii) multiple doses of the medicament.

12. An oral appliance according to claim 1 , wherein the medicament comprises at least one analgesic, whitening agent, breath freshener, anti-inflammatory, anticalculus agent, antimicrobial, anesthetic, muscle relaxant, selective H-2 antagonists, anticaries agent, nutrient, vitamin, mineral, herbal product, or mixtures thereof.

13. An oral appliance according to claim 1 , wherein the oral appliance is constructed from a digital data set or a physical model thereof representing at least a portion of the teeth and/or soft tissue areas inside the mouth.

14. An oral appliance according to claim 1 , wherein the oral appliance is constructed from a digital data set or a physical model thereof representing all of the teeth and soft tissue areas inside the mouth.

15. An oral appliance according to claim 1 , wherein the porous material is saturated with liquid medicament for optimum flow to deliver the medicament.

16. An oral appliance according to claim 1 , wherein the porous material comprises a hydrogel.

17. An oral appliance according to claim 1 , wherein the cargo area comprises a trapezoidal section.

18. An oral appliance according to claim 1 , wherein the porous material has increased thickness and a trapezoidal section to lock into the cargo area.

19. An oral appliance according to claim 1 , wherein the oral appliance is a custom fit oral appliance.

20. An oral appliance according to claim 1 , wherein the porous material protrudes from the inner surface and is configured to maintain contact with the teeth and soft tissue after healing has occurred.

21. An oral appliance according to claim 1 , wherein the porous material extends to the occlusal surfaces of the teeth.

22. An oral appliance according to claim 1 , wherein the oral appliance has two closed ends.

23. An oral appliance according to claim 1 , wherein the porous material has a portion having increased thickness that is complementary to and locks into the cargo area.

24. A method of delivering medicament to teeth and soft tissue areas inside a mouth, the method comprising: providing an oral appliance comprising an interior surface and a porous material disposed on the interior surface of the oral appliance and containing a medicament, the interior surface being formed to fit contours of the teeth and soft tissue areas inside the mouth and being capable of holding a contacting surface of the porous material in contact with the teeth and soft tissue areas inside the mouth; and covering at least the portion of the teeth and soft tissue areas inside the mouth with the oral appliance supporting the porous material so that the porous material contacts the teeth and soft tissue areas inside the mouth to deliver the medicament, wherein the porous material is a single continuous piece configured to be supported and held within a cargo area, the cargo area being a portion of the oral appliance that is configured to be continuous and extends all around a gum line perimeter from a buccal area to a lingual area, the cargo area corresponding to a gum line, the cargo area including an internal space provided by an extension of an internal wall surface of the interior surface that is for holding and supporting the porous material, wherein the porous material in the cargo area is disposed between the gum line and the teeth, and the porous material retains and seals the medicament in the gum line and the teeth; applying the oral appliance to the teeth such that the medicament is released passively.

25. A method according to claim 24 , further comprising maintaining the oral appliance for a sufficient time to allow a therapeutically effective amount of the medicament to be delivered.

26. A method according to claim 24 , wherein the medicament comprises at least one analgesic, whitening agent, anti-inflammatory, anticalculus agent, antimicrobial, anesthetic, selective H-2 antagonists, anticaries agent, nutrient, vitamin, mineral, herbal product, or mixtures thereof.

27. A method according to claim 24 , wherein the medicament comprises at least one systemic drug.

28. A method according to claim 24 , wherein the porous material comprises a hydrogel.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2019
From: ZEGARELLI, PETER J.
To: EMANATE BIOMEDICAL INC.
Reel/Frame 049569/0475 →
Continuity (3)
Continuation 13370763 · Feb 10, 2012
Continuation 11986727 · Nov 26, 2007
Related Publication 20140023994A1 · Jan 23, 2014