Orthodontic devices for delivery of an active agent

A device comprising:

• a first polymer shell contoured to fit at least a portion of a subject's upper or lower teeth, the first polymer shell having an inner surface, an outer surface, and a first shell edge member;
• a second polymer shell dimensioned to receive the first polymer shell, the second polymer shell having an inner receiving surface and an outer external surface, and a second shell edge member,
• wherein the first edge member and the second edge member are joined to form a first gap between the outer surface and the inner receiving surface;
• and
• a first agent disposed in the first gap,
• wherein the device is configured for insertion into an oral cavity of a subject for delivery of the first agent for controlled release over a time period;
• wherein the first and second shell edge members are comprised of an inner and an outer edge;
• and
• wherein the inner edge and the outer edge of the second shell each form an arch with a length, respectively, of 12-inner and 12-outer, and the inner edge and the outer edge of the first shell each form an arch with a length, respectively, of 11-inner and 11-outer, and the first shell inner edge and the second shell inner edge are sealed at one or more discrete points along the lengths 11-inner and 12-inner, and the first shell outer edge and the second shell outer edge are sealed at one or more discrete points along the lengths 11-outer and 12-outer, to form a plurality of peripheral edge sealing points.

A kit, comprising:

• a device, comprising:
• a first polymer shell contoured to fit at least a portion of a subject's upper or lower teeth, the first polymer shell having an inner surface, an outer surface, and a first shell edge member;
• a second polymer shell dimensioned to receive the first polymer shell, the second polymer shell having an inner receiving surface and an outer external surface, and a second shell edge member,
• wherein the first edge member and the second edge member are joined to form a gap between the outer surface and the inner receiving surface;
• and
• an agent configured for insertion into the gap;
• wherein the device is configured for insertion into an oral cavity of a subject for delivery of the agent for controlled release over a time period;
• wherein the first and second shell edge members are comprised of an inner and an outer edge;
• and
• wherein the inner edge and the outer edge of the second shell each form an arch with a length, respectively, of 12-inner and 12-outer, and the inner edge and the outer edge of the first shell each form an arch with a length, respectively, of 11-inner and 11-outer, and the first shell inner edge and the second shell inner edge are sealed at one or more discrete points along the lengths 11-inner and 12-inner, and the first shell outer edge and the second shell outer edge are sealed at one or more discrete points along the lengths 11-outer and 12-outer, to form a plurality of peripheral edge sealing points.