DEVICES AND METHODS FOR TREATING MAXILLARY SINUS DISEASE

• US 20110112512A1
• Filed: 12/16/2009
• Published: 05/12/2011
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Levine, Howard, Chan, Randy S., Harfe, Daniel T., Ha, Hung V., Muni, Ketan P.
• Granted Patent: US 9,351,750 B2
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Devices and methods are described for improving drainage and/or aeration of maxillary sinuses and for treating maxillary sinus disease. Spacer devices are implanted through natural or man-made openings in the maxillary sinus. In some embodiments, the spacer device is loaded with a therapeutic substance which then exits the device over a desired time period to treat maxillary sinus disease.

Claims

1. A method for treating a disorder of a maxillary sinus in a human or animal subject, the method comprising:

forming an opening into the maxillary sinus;

advancing a sinus spacer device at least partway through the opening;

deploying at least one retention member of the spacer device to retain at least part of the spacer device within the maxillary sinus;

introducing a substance into the spacer device to expand the device from a collapsed to an expanded configuration; and

leaving the spacer device in the subject for a period of between 1 day and 60 days to allow the introduced substance to exit the spacer device and treat the disorder.

2. A method according to claim 1, wherein forming an opening into a maxillary sinus comprises forming an opening between the nasal cavity and a maxillary sinus through a wall of the sinus.

3. A method according to claim 2, wherein the opening is formed by inserting a penetrator through an inferior or middle nasal meatus and into the maxillary sinus.

4. A method according to claim 3, wherein the penetrator comprises a shaft having a penetrating distal end and a curve of about 80 degrees to about 110 degrees.

5. A method according to claim 1, wherein the opening is formed such that it enters the maxillary sinus at a downward angle.

6. A method according to claim 1, wherein forming an opening into a maxillary sinus comprises forming an opening between the oral cavity and the maxillary sinus.

7. A method according to claim 6, wherein the opening is formed through the canine fossa.

8. A method according to claim 1, further comprising using an image guidance system to determine or confirm positioning of the penetrator.

9. A method according to claim 1, wherein a penetrator that has a curve and an indicator flag for indicating the direction of the curve is used to form the opening, the method further comprising using the indicator flag to determine or confirm the direction of the penetrator curve.

10. A method according to claim 1, wherein a penetrator having a lumen is used to form the opening, and wherein advancing the spacer device comprises:

advancing a guide member through the lumen of the penetrator, through the opening and into the maxillary sinus; and

advancing the spacer device over the guide member.

11. A method according to claim 10, wherein the guide member comprises a guidewire.

12. A method according to claim 1, wherein advancing the spacer device comprises:

inserting a tubular guide into the opening;

advancing the spacer device through the tubular guide; and

removing the tubular guide, leaving the spacer device positioned within the opening or maxillary sinus.

13. A method according to claim 1, wherein the spacer device comprises an elongate member having a lumen into which a stylet is receivable, and wherein advancing the spacer device comprises:

inserting a stylet into the lumen of the elongate shaft;

inserting the spacer device and stylet through the opening; and

removing the stylet.

14. A method according to claim 1, wherein the retention member comprises at least one projection and wherein the method further comprises:

maintaining said at least one projection in a collapsed position while the at least part of the spacer device is inserted through the opening; and

causing said at least one projection to transition to an extended position whereby it said at least one projection mechanically contacts at least one adjacent anatomical structure.

15. A method according to claim 14, wherein said at least one projection comprises first and second laterally opposed projections which, when in their extended positions, span a diameter of about 14 mm to about 20 mm.

16. A method according to claim 1, further comprising anchoring the spacer device.

17. A method according to claim 16, wherein anchoring the spacer device comprises suturing the spacer device to tissue.

18. A method according to claim 1, further comprising at least one of aerating the maxillary sinus and draining the maxillary sinus through a central open lumen of the spacer device.

19. A method according to claim 1, wherein the substance comprises saline solution.

20. A method according to claim 1, wherein the substance comprises a fluid, and wherein the fluid exits the spacer device through multiple pores on the device.

21. A method according to claim 1, wherein the substance comprises a therapeutic agent.

22. A method according to claim 21, wherein the therapeutic agent comprises a steroid.

23. A method according to claim 22, wherein the steroid comprises triamcinolone.

24. A method according to claim 23, wherein the spacer is constructed such that a dose of about 100 micrograms per day of triamcinolone will exit the spacer.

25. A method according to claim 1, wherein the substance continues to exit the spacer device for between about 14 days and about 21 days.

26. A method for treating a disorder of a maxillary sinus in a human or animal subject, the method comprising:

dilating a maxillary sinus ostium;

advancing a sinus spacer device at least partway through the maxillary sinus ostium;

deploying at least one retention member of the spacer device to retain at least part of the spacer device within the maxillary sinus;

introducing a substance into the spacer device to expand the device from a collapsed to an expanded configuration; and

leaving the spacer device in the subject for a period of between 1 day and 60 days to allow the introduced substance to exit the spacer device and treat the disorder.

27. A method according to claim 26 wherein the step of dilating the maxillary sinus ostium comprises dilating the maxillary sinus ostium and ethmoid infundibulum.

28. A method according to claim 27, wherein dilating the maxillary sinus ostium and ethmoid infundibulum comprises:

positioning an expandable dilator within the maxillary sinus ostium and ethmoid infundibulum; and

expanding the dilator.

29. A method according to claim 28, wherein the expandable dilator comprises a balloon, and wherein the step of expanding the dilator comprises inflating the balloon.

30. A system useable for treating a disorder of a maxillary sinus, the system comprising:

a sinus spacer device that comprises;

an elongate shaft having a lumen, a proximal end and a distal end;

an expandable reservoir attached to the distal end of the elongate shaft such that a substance may be introduced through the lumen of the elongate shaft into the expandable reservoir, thereby causing the reservoir to expand to a diameter of from about 3 mm to about 8 mm and a length of from about 1 mm to about 100 mm; and

retention projections located proximal to the expandable reservoir, said retention projections being initially disposable in a collapsed configuration and subsequently transitionable to an expanded configuration wherein the retention projections span a diameter of from about 14 mm to about 20 mm; and

a stylet having a proximal end, a distal end and an outer diameter sized to allow insertion of the stylet into the lumen of the elongate shaft.

31. A system according to claim 30 wherein the expandable reservoir is constructed to allow a substance that has been introduced into the reservoir to exit the reservoir.

32. A system according to claim 30 wherein the stylet is curved.

35. A system according to claim 30 wherein the stylet is malleable.

34. A system according to claim 33 wherein the curve in the stylet is approximately 90 degrees to approximately 110 degrees.

36. A system for treating a disorder of a maxillary sinus, the system comprising:

a sinus spacer device, comprising;

an elongate shaft having a lumen, a proximal end and a distal end;

an expandable reservoir attached to the distal end of the elongate shaft such that a substance may be introduced through the lumen of the elongate shaft into the expandable reservoir, thereby causing the reservoir to expand to a diameter of from about 3 mm to about 8 mm and a length of from about 1 mm to about 100 mm; and

retention projections located proximal to the expandable reservoir, said retention projections being initially disposable in a collapsed configuration and subsequently transitionable to an expanded configuration wherein the retention projections span a diameter of from about 14 mm to about 20 mm; and

a tubular delivery guide having a lumen through which the spacer device is insertable.

37. A system according to claim 36 wherein the tubular delivery guide has a proximal portion and a distal portion, the distal portion being more flexible than the proximal portion.

38. A system according to claim 36 wherein the tubular delivery guide has a proximal portion and a distal portion, the proximal portion being malleable.

39. A system according to claim 36 wherein the tubular delivery guide has a proximal portion and a distal portion, a curve being formed in the distal portion.

40. A system according to claim 39 wherein the curve is from approximately 80 degrees to approximately 110 degrees.

41. A system according to claim 36 further in combination with a stylet that has a distal end, said stylet being insertable into and removeable from the lumen of the elongate shaft.

42. A system according to claim 41 wherein the tubular delivery guide is curved and the stylet is sufficiently flexible to advance through the curve of the tubular guide.