Devices and methods for dilating a paranasal sinus opening and for treating sinusitis
Medical devices which are adapted to be inserted into a patient for a limited period of time using minimally invasive insertion procedures for dilating a stenotic opening, such as a stenotic sinus opening, are provided. The devices and methods can be used for treating sinusitis and other nasal and/or sinus disorders.
1. A device for dilating a stenotic opening of a paranasal sinus in a subject, the device comprising:
(a) a self-expanding osmotic driver comprising a first osmotic driver and a second osmotic driver positioned distal to the first driver, the self-expanding osmotic driver configured to expand an expandable portion from a non-expanded configuration to an expanded configuration, the expandable portion disposed peripherally around the first and second osmotic drivers and configured to expand from the non-expanded configuration to the expanded configuration, wherein the non-expanded configuration is sized to be positioned within the stenotic opening; and
(b) a drug reservoir positioned between the first and second drivers and within the expandable portion.
2. The device of claim 1 , wherein the drug reservoir is configured to release a drug as the first and second osmotic drivers expand from a non-expanded configuration to an expanded configuration.
3. The device of claim 1 , wherein the expandable portion comprises an elastic semipermeable membrane, wherein the drug diffuses through the membrane during use of the device.
4. The device of claim 1 , wherein the drug is water soluble.
5. The device of claim 1 , wherein the drug is selected from an antibiotic, an anti-inflammatory drug, a local anesthetic, an analgesic or a combination thereof.
6. The device of claim 1 , wherein the driver is configured to expand the expandable portion from the non-expanded configuration to the expanded configuration over a period of 0.5 hours or more.
7. The device of claim 1 , wherein the driver is configured to expand the expandable portion from the non-expanded configuration to the expanded configuration over a period of 2 hours or less.
8. The device of claim 1 , wherein each of the first and second osmotic drivers comprises an osmotically active agent.
9. The device of claim 1 , comprising a conduit defining an interior lumen, wherein the conduit comprises a distal end configured to be in fluid communication with an interior cavity of the paranasal sinus in the subject and a proximal end configured to be in fluid communication with a nasal cavity in the subject, and wherein the conduit is configured to allow fluid flow between the interior cavity of the paranasal sinus and the nasal cavity when the device is positioned within the stenotic opening.
10. The device of claim 1 , wherein the expandable portion comprises a semipermeable membrane.
11. The device of claim 1 , comprising a proximal anchor proximate to the proximal end of the device, wherein the proximal anchor is configured to maintain the device within the stenotic opening during device expansion.