Drug-coated balloon

• US 10,603,473 B2
• Filed: 07/26/2019
• Issued: 03/31/2020
• Est. Priority Date: 01/22/2015
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Kaufman, Richard E., Stankus, John Joseph, Su, James
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US16/523,836
• Publication Number:
  US 20200016377A1
• Time in Patent Office: 249 Days
• Field of Search: 604514
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/065 Throat; Pharynx
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 2210/0675 Eustachian tube
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2210/105 Oesophagus
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Described here are devices, systems, and methods for treating conditions or diseases of the nose, ear, or throat with an expandable device having a drug coating. The expandable devices may be delivered to a body cavity in a low-profile configuration and expanded to contact surrounding tissue. The expandable devices may deliver or release the drug coating to the tissue. Multiple expansions of a single device may be employed during treatment. Various coating excipients and manufacturing parameters for the expandable devices may also be adjusted to enhance or slow transfer of the drug coating and/or release of the drug to the target tissue site. The drug transferred to the tissue may act as an in situ depot that enables maintenance of a therapeutic level of locally delivered drug for a desired time period after removal of the expandable devices.

Claims

1. A system for delivering treatment to a nasal, otic, or throat tissue site, comprising:

an expandable device having a low-profile configuration and an expanded configuration, and having a drug coating on an external surface thereof;

a delivery device having a sheath, the expandable device disposed within the sheath in the low-profile configuration until deployment at one or more target tissue sites; and

an inflation source in fluid communication with the expandable device, configured to expand the expandable device one or more times, where expansion of the expandable device transfers a portion of the drug coating from the external surface of the expandable device to the one or more target tissue sites, and where transfer of the drug coating maintains a therapeutic level of local drug delivery.

2. The system of claim 1, wherein the inflation source is configured to deliver a fluid or a gas to an interior of the expandable device and thereby expand the expandable device, and wherein the inflation source is further configured to withdraw the fluid or gas from the interior of the expandable device and thereby collapse the expandable device.

3. The system of claim 1, wherein the drug coating comprises at least one of a local anesthetic, painkiller, vasoconstrictor, antiseptic, antioxidant, anti-inflammatory agent, anti-allergen agent, anti-cholinergic agent, antihistamine, anti-infective agent, anti-platelet agent, anti-coagulant, anti-thrombotic agent, anti-scarring agent, anti-proliferative agent, chemotherapeutic agent, anti-neoplastic agent, decongestant, healing promoting agent, vitamin, hypersomolar agent, immunomodulator, immunosuppressive agent, mucolytic, or combination thereof.

4. The system of claim 1, wherein the drug coating comprises mometasone furoate or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof.

5. The system of claim 1, wherein the drug coating comprises a drug and one or more excipients, with a drug to excipient ratio ranging from 3:

1 to 1;

3.

6. The system of claim 5, wherein the excipient comprises at least one of a poly(vinyl pyrrolidone), polysorbate, poly(ethylene glycol), phospholipid, fatty acid, sodium dodecyl sulfate, poloxamer, hydroxypropyl-beta-cyclodextrin, sucrose fatty acid monoester, or combination thereof.

7. The system of claim 1, wherein the drug coating comprises at least one of a chitosan, collagen, elastin, silk, silk-elastin, alginate, cellulose, dextran, polyalkoanates, hyaluronic acid, gelatin, and gellan, polylactide, poly(lactide-co-glycolide), poly(lactide-co-ε

-caprolactone), polyglycolide, polyhydroxybutyrate, polyhydroxyvalerate, poly(ethylene glycol), polydioxanone, polyglactin, poly(ε

-caprolactone), polyglyconate, poly(glycolide-co-trimethylene carbonate), poly(sebacic acid), poly(ester urethane), poly(ester urethane) urea, cross-linked PEG, polyNIPAAM, PEG-PLA block copolymer, poloxamer or combination thereof.

8. The system of claim 1, wherein the drug in the drug coating has a dose density ranging from about 100 μ

g/cm² to about 600 μ

g/cm².

9. The system of claim 1, wherein the drug coating has a thickness on the external surface of the expandable device of from about 10 μ

m to about 500 μ

m.

10. The system of claim 1, wherein the delivery device further comprises an optical fiber that illuminates the position of the device with respect to the target tissue sites.

11. The system of claim 1, wherein the expandable device is expanded at multiple target tissue sites.

12. The system of claim 11, wherein the expandable device has a plurality of pleats or folds that promote return to the low-profile configuration and prevent loss of the drug coating after each expansion at the multiple target tissue sites.

13. The system of claim 1, wherein the drug coating is patterned on the exterior surface of the expandable device in a configuration for anatomy specific to the at least one target tissue sites.

14. The system of claim 1, wherein the delivery device has a malleable distal tip.

15. The system of claim 1, further comprising a topcoat applied on the drug coating, the topcoat being configured to dissolve upon contact with the at least one target tissue sites.

16. The system of claim 1, wherein the delivery device further comprises a guidewire, with the expandable device arranged to move along the guidewire.

17. A method of treating a nasal, otic, or throat condition, comprising:

providing an expandable device comprising a drug coating on an external surface thereof and having a low-profile configuration and an expanded configuration;

delivering the expandable device in the low-profile configuration to a target tissue site;

transferring a portion of the drug coating from the external surface to the target tissue site by at least one expansion of the expandable device;

removing the expandable member from the target tissue site; and

maintaining a therapeutic level of local drug delivery at the target tissue site from the transferred drug coating for a time period effective to treat the target tissue site.

18. The method of claim 17, wherein the expandable device is expanded at multiple target tissue sites, and wherein transfer of drug coating to each target tissue site is by at least one expansion of the expandable device at each target tissue site.

19. The method of claim 17, wherein transfer of drug coating delivers about 0.5 mg to about 3.0 mg of the drug to the target tissue site.

20. The method of claim 17, wherein the nasal condition is selected from the group consisting of post-surgical inflammation, turbinate hypertrophy, rhinosinusitis, and rhinitis.

21. The method of claim 17, wherein the target tissue site is a maxillary sinus, a frontal sinus, an ethmoidal sinus, a sphenoidal sinus, a sinus ostium, an inferior turbinate, a middle turbinate, a superior turbinate, a nasal cavity, the osteomeatal complex, the nasopharynx, adenoid tissue, or a combination thereof.

22. The method of claim 17, wherein the otic condition is selected from the group consisting of post-surgical inflammation, otitis media, Meniere'"'"'s disease, Eustachian tube dysfunction, and tinnitus, and wherein the target tissue site is the Eustachian tube, external ear canal, or middle ear.

23. The method of claim 17, wherein the throat condition is selected from the group consisting of post-surgical pain, esophageal cancer, airway stenosis, chronic laryngitis, tonsillitis, and epiglottitis.

24. The method of claim 17, wherein the expandable device is an inflatable balloon that distends upon inflation to the expanded configuration at an inflation pressure between about 2 atm and 16 atm.

25. The method of claim 17, wherein each expansion of the expandable device is a time period of from about 5 seconds to about 5 minutes.

26. The method of claim 17, wherein the time period effective to treat the target tissue site is up to 90 days.

27. The method of claim 17, wherein about 60% of the drug coating is transferred to the target tissue site upon expansion of the expandable device.

28. The method of claim 17, wherein about 40% of the drug coating is transferred to the target tissue site upon expansion of the expandable device.

29. The method of claim 17, wherein about 25% of the drug coating is transferred to the target tissue site upon expansion of the expandable device.

30. The method of claim 17, wherein about 20% of the drug coating is transferred to the target tissue site upon expansion of the expandable device.