Ethmoidotomy System and Implantable Spacer Devices Having Therapeutic Substance Delivery Capability for Treatment of Paranasal Sinusitis

• US 20080287908A1
• Filed: 04/09/2008
• Published: 11/20/2008
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Ha, Hung V., Makower, Joshua, Muni, Ketan P., Chan, Randy S., Facteau, William M., Chang, John Y., Van, Nga K., Levine, Howard L.
• Granted Patent: US 8,864,787 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 2090/062 penetration depth
• CPC Class Codes: A61F 11/20 Ear surgery
• 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 25/0075 Valve means
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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
• 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

Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Claims

1. A method for treating ethmoid sinusitis in a patient using a penetrator that has a distal tip and a stopping mark or member located a spaced distance proximal to the distal tip, said spaced distance being less than the known distance between the ethmoid bulla and the ipsalateral sphenoid sinus, the method comprising:

forming an ethmoidotomy channel by advancing the penetrator through the ethmoid bulla in a direction that is non-perpendicular to the skull base and generally directed toward the ipsalateral sphenoid sinus;

stopping advancement of the penetrator when the stopping mark or member is approximately flush with the ethmoid bulla; and

removing the penetrator.

2. A method according to claim 1, further comprising inserting a spacer device into the ethmoidotomy channel.

3. A method according to claim 2, wherein inserting the spacer device comprises advancing it through a sheath delivered at least partway through the ethmoidotomy channel by the penetrator.

4. A method according to claim 1, wherein advancing the penetrator comprises advancing a needle.

5. A method according to claim 1, wherein advancing the penetrator comprises advancing a drill.

6. A method according to claim 1, wherein stopping advancement of the mark or member comprises viewing a mark of a color on the penetrator that is different from the color of blood or mucosal tissue.

7. A method according to claim 1, wherein stopping advancement of the stopping mark or member comprises feeling tactile feedback from the penetrator as a stopping member contacts the ethmoid bulla.

8. A method according to claim 1, further comprising releasing a stopping member selected from the group consisting of a shoulder, a projection, a wire loop and a wing from within a sheath disposed over a portion of the penetrator.

9. A method according to claim 1, wherein stopping advancement of the stopping mark or member comprises contacting a stopping member on the penetrator with the patient'"'"'s nose.

10. A sinus penetrator device useable for forming an opening in one or more paranasal sinus or ethmoid air cell, the device comprising:

an elongate penetrator having a proximal end and a distal end; and

a stopping mark or member which substantially limits the depth to which the penetrator can penetrate into the sinus or air cell.

11. A device according to claim 10, wherein the penetrator comprises a needle.

12. A device according to claim 10, wherein the penetrator comprises a drill.

13. A device according to claim 10, wherein the stopping mark or member comprises a mark of a color that is different from the color of blood or mucosal tissue so as to be visually distinguishable.

14. A device according to claim 10, wherein the penetrator comprises an elongate member having a curve formed therein.

15. A device according to claim 14, wherein the curve is located about 20 mm to about 24 mm from a distal end of the penetrator.

16. A device according to claim 14, wherein the curve forms and angle of about 33 degrees.

17. A device according to claim 14, wherein the curve has a radius of curvature of about 0.75.

18. A device according to claim 10, wherein the penetrator comprises a needle in combination with a sheath that is positionable over the needle.

19. A device according to claim 18, wherein the stopping mark or member is located on the sheath at a location approximately 2 cm from a distal end of the sheath.

20. A device according to claim 10, wherein the device is to be used for penetration through the ethmoid bulla, and wherein the stopping mark or member comprises a stop member that abuts against the ethmoid bulla as the penetrator is advanced.

21. A device according to claim 20, wherein the stopping mark or member is located such that the distance to which the penetrator may be advanced through the ethmoid bulla is less than the distance between the ethmoid bulla and the ipsalateral sphenoid sinus, thereby substantially preventing the penetrator from entering the sphenoid sinus.

22. A device according to claim 10, wherein the stopping mark or member comprises a shoulder, projection, wire loop or wing that extends generally laterally from the penetrator.

23. A device according to claim 10, wherein the stopping mark or member comprises a stop member that abuts against the subject'"'"'s nose thereby limiting the extent to which the penetrator can be inserted into the nose.

24. A device for forming an ethmoidotomy in an ethmoid sinus of a patient'"'"'s head, the device comprising:

an elongate penetrator member having a proximal end and a sharp distal end;

a handle coupled with the penetrator member at or near the proximal end; and

a sighting member disposed along the handle or the elongate member at a location to make it visible from an extracorporeal vantage point when the distal end of the elongate member is inserted into the patient, wherein the sighting member is useable by a user of the device to generally aim the distal end of the penetrator in a desired direction within the patient'"'"'s head.

25. A device according to claim 24, wherein the handle comprises a top elongate member and a bottom elongate member that is attached to and substantially parallel to the top elongate member.

26. A device according to claim 25, further comprising a distal grip portion attached to distal ends of the top and bottom elongate members.

27. A device according to claim 24, which is fully or partially coated with an elastomeric material.

28. A device according to claim 24, wherein the sighting member comprises a fin.

29. A device according to claim 24, wherein the sighting member comprises a member that extends in a plane that is substantially parallel to a plane in which the elongate penetrator extends from the handle.

30. A device according to claim 29, wherein the sighting member further comprises a member that extends in a plane that is substantially normal to the plane in which the elongate penetrator extends from the handle.

31. A device according to claim 24, wherein the elongate working member has a curve, a proximal portion proximal to the curve and a distal portion distal to the curve, and wherein at least a portion of the sighting member is parallel to the distal portion of the elongate working member to thereby provide an indication of the direction or trajectory on which the distal portion of the elongate working member is being advanced.

32. A device according to claim 24, wherein the penetrator member comprises a needle.

33. A device according to claim 24, wherein the penetrator member comprises a drill.

34. A device according to claim 24, further comprising a stopping mark or member that limits the depth to which the penetrator can penetrate into the paranasal sinus or air cell.

35. A device according to claim 34, wherein the penetrator comprises a needle in combination with a sheath that is positionable over the needle.

36. A device according to claim 35 wherein the stopping mark or member is located on the sheath at a location approximately 2 cm from a distal end of the sheath.

37. A substance delivering spacer device that may be loaded with a therapeutic substance for delivery of the therapeutic substance, the device comprising:

an elongate tubular shaft;

an expandable reservoir on the shaft into which the therapeutic substance may be loaded, the reservoir having a substantially cylindrical side wall and tapered ends, openings being formed in the sidewall and tapered ends of the reservoir such that a therapeutic substance loaded into the reservoir will elute through the openings and out of the reservoir.

38. A device according to claim 37, wherein each opening has a diameter of about 20 microns to about 40 microns in diameter.

39. A device according to claim 38, wherein approximately 768 of the openings are formed in the reservoir.

40. A device according to claim 39, wherein approximately 672 openings are formed in the substantially cylindrical side wall and approximately 48 openings are formed in each tapered end of the reservoir.

41. A device according to claim 37, wherein the reservoir has an overall length of about 16 mm.

42. A device according to claim 41, wherein the substantially cylindrical side wall of the reservoir has a length of about 13 mm and each tapered end portion has a length of about 1.5 mm.

43. A device according to claim 42, wherein the reservoir has a diameter of about 3.0 mm to about 3.5 mm when fully expanded.

44. A device according to claim 37, further comprising one or more retention members that frictionally engage adjacent tissue to hold the device in a desired location within a patient'"'"'s body.

45. A device according to claim 37, further comprising one or more suture receiving members to facilitate suturing of the device in place within a patient'"'"'s body.

46. A device according to claim 37, further comprising a constraining sheath that has a retracted position and an advanced position, said constraining sheath extending over said reservoir while the reservoir is in a collapsed state and the constraining sheath is in the advanced position.

47. A device according to claim 46 wherein at least a portion of the constraining sheath is transparent or sufficiently translucent to allow a user to see through the constraining sheath.

48. A system comprising a substance delivering spacer device according to claim 37 in combination with a sinus penetrator and a sheath, the sheath being disposed over the sinus penetrator, wherein the penetrator and sheath are configured to be advanced through a wall of a paranasal sinus or air cell, the penetrator being thereafter removable to leave the sheath in place, wherein the substance delivering spacer device is advanceable into the sheath, the sheath being thereafter removable, leaving the substance delivering spacer device in place within the sinus or air cell and a substance being thereafter injectable into the reservoir such that the substance will elute from the reservoir into the paranasal sinus or air cell.

49. A method for treating sinusitis, the method comprising:

placing an implantable device having a substance eluting reservoir within a paranasal sinus or within the ostium of a paranasal sinus;

introducing a steroid into the substance eluting reservoir so that the steroid elutes from the reservoir in an amount that is effective to treat the sinusitis.

50. A method according to claim 49, wherein introducing the steroid comprises introducing a Triamcinolone Acetonide suspension.

51. A method according to claim 49, wherein the steroid is in the form of a suspension and wherein the method further comprises adding additional liquid to the reservoir.

52. A method according to claim 49, wherein the method further comprises adding additional steroid to the reservoir.

53. A method according to claim 49, wherein introducing the steroid comprises introducing a steroid solution.

54. A method according to claim 53, wherein the steroid solution comprises at least one steroid dissolved in at least one cyclodextrin.

55. A method according to claim 49, wherein the reservoir is expandable and, when substantially fully expanded, has a working length of about 16 mm and proximal and distal tapers of about 1.5 mm each, a diameter of about 3.0 mm and a total of about 768 openings through which the therapeutic substance may elute.