FRONTAL SINUS SPACER

• US 20090198216A1
• Filed: 12/22/2008
• Published: 08/06/2009
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Van, Nga K., Ha, Hung V., Muni, Ketan P., Chan, Randy S.
• Granted Patent: US 8,764,729 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 17/3417 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 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0226 specifically adapted for the nose
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• 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 2210/0618 Nose
• 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 25/0662 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. 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 substance delivering sinus spacer system for delivering a substance to a frontal paranasal sinus, the system comprising:

a curved delivery guide configured to extend through a nostril to position a distal end of the guide in or near an ostium of a frontal paransal sinus while a proximal end of the guide is located outside of the nostril;

an elongate substance delivery catheter having a proximal end and a distal end; and

a substance delivering sinus spacer device extending from and in fluid communication with the distal end of the delivery catheter, the spacer device including;

an elongate tubular shaft with an atraumatic tip;

an expandable reservoir attached to the shaft and into which the therapeutic substance may be loaded; and

at least two collapsible retention members configured adjacent and longitudinally overlapping the reservoir.

2. The system of claim 1, further comprising a sheath removably disposed over the sinus spacer device to hold the retention members in a collapsed configuration, the sheath comprising a stop at or near its proximal end for stopping advancement of the sheath through the delivery guide.

3. The system of claim 2, wherein the substance delivery catheter comprises a marker disposed along part of its length such that when the delivery catheter and sheath are advanced into the guide, when a distal end of the marker reaches the proximal end of the sheath the atraumatic tip of the sinus spacer is positioned at the distal end of the guide, and when a proximal end of the marker reaches the proximal end of the sheath the collapsible retention members are positioned outside of the distal end of the guide.

4. The system of claim 1, wherein the curved delivery guide comprises a rigid proximal portion and a flexible, curved distal portion.

5. The system of claim 4, wherein the delivery guide further comprises a radiopaque distal tip.

6. The system of claim 1, wherein the substance delivery catheter is opaque and the sinus spacer device is translucent.

7. The system of claim 1, further comprising a suture loop coupled with the sinus spacer device for attached the sinus spacer to tissue inside the nasal cavity or frontal sinus outflow tract.

8. The system of claim 1, wherein the catheter further comprises a luer connection coupled with its proximal end for coupling the catheter with a source of the substance.

9. The system of claim 1, further comprising a handle removably couplable with the proximal end of the guide.

10. The system of claim 1, further comprising an amount of the substance.

11. The system of claim 1, wherein the substance comprises a steroid.

12. The system of claim 11, wherein the steroid comprises triamcinolone acetonide.

13. The system of claim 1, wherein the reservoir of the sinus spacer device has 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.

14. The system of claim 2, wherein each opening has a diameter of about 20 microns to about 40 microns.

15. The system of claim 1, wherein the retention members of the sinus spacer device comprise looped wings.

16. The system of claim 15, wherein the retention members have a wing span of between about 13 mm and about 16 mm in an expanded configuration.

17. The system of claim 1, wherein the retention members are diametrically opposed on the shaft.

18. The system of claim 1, wherein the retention members are staggered along a longitudinal dimension of the device.

19. The system of claim 1, wherein retention members are attached along a common side of the shaft.

20. A method for delivering a substance to a paranasal sinus, the method comprising:

advancing a guide device through a nostril to position a distal end of the guide device in or near a natural ostium of a paranasal sinus;

advancing a substance delivery sinus spacer device extending from a distal end of an elongate catheter out of the distal end of the guide device and into the paranasal sinus such that retention members on the sinus spacer deploy to retain the spacer in the paranasal sinus;

introducing a substance into a substance eluting reservoir of the sinus spacer so that the substance elutes from the reservoir through multiple apertures;

separating the sinus spacer from the catheter; and

removing the guide and the catheter from the nostril, leaving the sinus spacer behind in the paranasal sinus.

21. The method of claim 20, wherein the guide, the spacer and the catheter are advanced into the nostril together, and wherein the spacer is then advanced out of the distal end of the guide.

22. The method of claim 20, wherein introducing the substance comprises introducing a steroid.

23. The method of claim 22, wherein introducing the steroid comprises introducing triamcinalone acetonide.

24. The method of claim 20, wherein the therapeutic substance is in the form of a suspension and wherein the method further comprises adding additional liquid to the reservoir.

25. The method of claim 20, wherein introducing the substance into the reservoir causes the reservoir to expand.

26. The method of claim 20, wherein the sinus spacer and the substance are delivered to a frontal paranasal sinus.

27. The method of claim 20, wherein the sinus spacer and the substance are delivered to a maxillary paranasal sinus.

28. The method of claim 20, wherein the sinus spacer and the substance are delivered to a sphenoid paranasal sinus.

29. The method of claim 20, wherein the sinus spacer and the substance are delivered to a ethmoid paranasal sinus.

30. The method of claim 20, wherein the sinus spacer is left behind in the paranasal sinus for a period of between seven and ninety days, the method further comprising removing the spacer from the paranasal sinus.

31. The method of claim 20, further comprising attaching the sinus spacer to mucosal tissue using a suture loop coupled with the spacer.

32. The method of claim 20, wherein separating the sinus spacer from the catheter comprises cutting at or near a junction of the spacer and the catheter.

33. The method of claim 20, further comprising attaching a handle to the guide device before advancing the guide device into the nostril.