- Patent Number:
5,924,863
- Appl. No:
08/872,778
- Application Filed:
June 11, 1997
- Abstract:
A device useful for delivering a predetermined treatment agent using a non-adhesive carrier for controlled regional release where the relationship between pore size, molecular weight, concentration and the like are predetermined to achieve specific predetermined time and quantity of release. The device includes a mouthguard shaped for extended contact with a substantial portion of the users mouth, such as all of the teeth and gums, for example, so as to provide treatment to a major region of the mouth as opposed to specific topical points of treatment. The mouthguard is held in position by properly fitting it to the patient, such as by softening and molding in situ. The portion of the mouthguard that is in direct contact with the region of treatment is formed from a polymeric material having a network of porous cavities that are sized to incorporate the treatment agent and release that agent over a predetermined period of time. The specific rate of release is controlled by balancing the molecular weight, molecule size, cavity dimensions, and specific properties of the carrying fluid, such as surface tension, solubility and viscosity. Specific preferred treating agents are sodium fluoride for cavity prevention and saliva control agents used during athletic sport participation.
- Inventors:
Jacobs, Allison J. (Bainbridge Island, WA); Schwendeman, Stephen (Dublin, OH)
- Claim:
We claim
- Claim:
1. A dual tray assembly useful for delivering a predetermined treatment agent to a major region of a user's mouth, comprising
- Claim:
an outer tray with a horseshoe shaped configuration having an open U-shaped cross section; and
- Claim:
means for forming a non-adhesive mouthguard carrier for controlled regional release, said carrier means being formed from a polymeric material having a network of porous cavities defining a treatment release region, said cavities being sized to incorporate a treatment agent and release said agent over a predetermined period of time, said carrier comprising an inner tray with a horseshoe shaped configuration having an open U-shaped cross section which extends over the teeth that removably nests inside the outer carrier tray making a dual tray assembly; the inner tray being made of a thermoplastic compound that is soft and pliable at elevated temperatures but is hard and flexible at body temperatures after the dual tray assembly at elevated temperature is placed in the patient's mouth and is conformed by pressure applied to the inner tray through the dual tray assembly; and
- Claim:
a treating agent in a treating fluid for release from said porous cavities in said treatment release region to provide for release of said agent over a predetermined contact time with a substantial portion of the users mouth, said agent having a molecular weight and concentration in said treating fluid such that the specific rate of release of said agent is controlled by the relationship of the molecular weight and molecule size of said agent, the cavity dimensions, and the specific properties of the carrying fluid.
- Claim:
2. The assembly of claim 1, wherein said inner tray has a thickness small enough for said outer carrier tray to replicate said conformation to the teeth and said outer carrier tray is made of a thermoplastic material that is soft at elevated temperatures so as to conform to said inner tray when said inner tray is being conformed to said set of teeth being modeled.
- Claim:
3. The dual tray assembly of claim 1, wherein the inner tray is pliable at temperatures between 145.degree.-160.degree. F.
- Claim:
4. The dual tray assembly of claim 1, wherein said inner tray is hard at temperatures below 120.degree. F.
- Claim:
5. The dual tray assembly of claim 1, wherein said inner tray can be repeatedly molded to the shape of the patient's teeth.
- Claim:
6. The dual tray assembly of claim 1, wherein said outer carrier tray wall is thicker than said inner tray wall.
- Claim:
7. The dual tray assembly of claim 6, wherein said inner tray has a wall thickness between 0.25 mm and 1.25 mm.
- Claim:
8. The dual tray assembly of claim 1, wherein said inner tray material includes polycaprolactone polymer.
- Claim:
9. The dual tray assembly of claim 8, wherein said inner tray thermoplastic material is principally polycaprolactone polymer.
- Claim:
10. The device of claim 1, wherein said specific properties of said treating fluid comprise its surface tension and viscosity.
- Claim:
11. The device of claim 1, wherein said properties further include the degree of solubility of said agent in said fluid.
- Claim:
12. The device of claim 1, wherein said agent is a source of fluoride for treatment of said teeth.
- Claim:
13. The device of claim 1, wherein said agent is a saliva control agent.
- Claim:
14. A dual tray assembly useful for delivering a predetermined treatment agent to a major region of a user's mouth, comprising
- Claim:
a carrier tray configured generally to conform to a patient's teeth; and
- Claim:
means for forming a non-adhesive mouthguard carrier for controlled regional release, said carrier means being formed from a thermoplastic compound including 50% to 80% by weight polycaprolactone and 10% to 40% by weight of ethylene vinyl-acetate, said compound having a network of porous cavities defining a treatment release region, said cavities being sized to incorporate a treatment agent and release said agent over a predetermined period of time, said carrier comprising an inner tray with a horseshoe shaped configuration having an open U-shaped cross section which extends over the teeth that removably nests inside the carrier tray making a dual tray assembly; and
- Claim:
a treating agent in a treating fluid for release from said porous cavities in said treatment release region to provide for release of said agent over a predetermined contact time with a substantial portion of the users mouth, said agent having a molecular weight and concentration in said treating fluid such that the specific rate of release of said agent is controlled by the relationship of the molecular weight and molecule size of said agent, the cavity dimensions, and the specific properties of the treating fluid.
- Claim:
15. The assembly of claim 14, wherein said polycaprolactone has a molecular weight ranging from 40,000 to 80,000.
- Claim:
16. The assembly of claim 14, wherein said ethylene vinyl-acetate has a proportion of vinyl acetate ranging from 24.3% to 25.7% by weight and a melt index between about 17.3 and 20.9 decigrams/minute.
- Claim:
17. The assembly of claim 14, wherein said inner tray further includes 5% to 10% by weight of a polystyrene butadiene copolymer.
- Claim:
18. The assembly of claim 14, wherein said inner tray further includes 1% to 15% silica filler.
- Claim:
19. The assembly of claim 14, wherein said carrier tray is made from an ethylene vinyl-acetate.
- Claim:
20. The device of claim 14, wherein said specific properties of said treating fluid comprise its surface tension and viscosity.
- Claim:
21. The device of claim 14, wherein said properties further include the degree of solubility of said agent in said fluid.
- Claim:
22. The device of claim 14, wherein said agent is a source of fluoride for treatment of said teeth.
- Claim:
23. The device of claim 14, wherein said agent is a saliva control agent.
- Claim:
24. A dual tray assembly useful for delivering a predetermined treatment agent to a major region of a user's mouth, comprising
- Claim:
a non-adhesive mouthguard carrier for controlled regional release, said carrier being formed from a polymeric material having a network of porous cavities defining a treatment release region, said cavities being sized to incorporate a treatment agent and release said agent over a predetermined period of time, said carrier comprising an inner tray with a horseshoe shaped configuration having an open U-shaped cross section which extends over the teeth that removably nests inside the outer carrier tray making a dual tray assembly; the inner tray being made of a thermoplastic compound that is soft and pliable at elevated temperatures but is hard and flexible at body temperatures after the dual tray assembly at elevated temperature is placed in the patient's mouth and is conformed by pressure applied to the inner tray through the dual tray assembly; and
- Claim:
25. The assembly of claim 24, wherein said inner tray has a thickness small enough for said outer carrier tray to replicate said conformation to the teeth and said outer carrier tray is made of a thermoplastic material that is soft at elevated temperatures so as to conform to said inner tray when said inner tray is being conformed to said set of teeth being modeled.
- Claim:
26. The dual tray assembly of claim 24, wherein the inner tray is pliable at temperatures between 145.degree.-160.degree. F. and hard at temperatures below 120.degree. F.
- Claim:
27. The dual tray assembly of claim 24, wherein said outer carrier tray wall is thicker than said inner tray wall and wherein said inner tray material includes polycaprolactone polymer.
- Claim:
28. The dual tray assembly of claim 24, wherein said specific properties of said carrying fluid comprise its surface tension and viscosity.
- Claim:
29. The device of claim 24, wherein said agent is selected from the group consisting of a source of fluoride for treatment of said teeth and a saliva control agent.
- Current U.S. Class:
433/80; 433/37
- Current International Class:
A61G 1702
- Patent References Cited:
3624909 December 1971 Greenberg
4428373 January 1984 Seid et al.
4531914 July 1985 Spinello
5011407 April 1991 Pelerin
5415544 May 1995 Oxman et al.
5503552 April 1996 Diesso
- Primary Examiner:
Lucchesi, Nicholas D.
- Attorney, Agent or Firm:
Munday, John S.
- Accession Number:
edspgr.05924863
Processing Request
No Comments.