Ethmoidotomy system and implantable spacer devices having therapeutic substance delivery capability for treatment of paranasal sinusitis

• US 8,864,787 B2
• Filed: 04/09/2008
• Issued: 10/21/2014
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Muni, Ketan P., Ha, Hung V., Chang, John Y., Chan, Randy S., Van, Nga K., Makower, Joshua, Facteau, William M., Levine, Howard L.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US12/100,361
• Publication Number:
  US 20080287908A1
• Time in Patent Office: 2,386 Days
• Field of Search: 604/500, 604508-510, 604/514, 604/516, 606/196, 128/204.12, 128/207.18, 424/434, 424/45, 514 35- 36
• US Class Current: 606/196
• 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 sinusitis, the method comprising:

obtaining or providing a substance eluting reservoir, said reservoir being inflatable from a non-expanded configuration to an expanded configuration and, when in said expanded configuration, having a side wall, proximal and distal tapers and a plurality of openings, the reservoir being mounted on a shaft that has a lumen through which the steroid may be introduced into the reservoir;

inserting the reservoir into a paranasal sinus or ostium of a paranasal sinus while the reservoir is in the non-expanded configuration; and

introducing a steroid through the shaft lumen and into the reservoir while the reservoir is positioned within the paranasal sinus or ostium of a paranasal sinus thereby inflating the reservoir to the expanded configuration and causing steroid to pass through the openings of the reservoir at a rate that is effective to treat the sinusitis;

wherein the method further comprises shortening the shaft so that the shaft does not protrude out of the patient'"'"'s nose.

2. A method according to claim 1, wherein introducing the steroid comprises introducing a Triamcinolone Acetonide suspension.

3. A method according to claim 2 wherein the reservoir delivers a dose of approximately 100 μ

g Triamcinolone Acetonide per day.

4. A method according to claim 1, wherein the steroid is in the form of a suspension and wherein the method further comprises adding additional liquid to the reservoir.

5. A method according to claim 1, wherein the method further comprises adding additional steroid to the reservoir.

6. A method according to claim 1, wherein introducing the steroid comprises introducing the steroid in solution form.

7. A method according to claim 6, wherein the steroid solution comprises at least one steroid dissolved in at least one cyclodextrin.

8. A method according to claim 1, wherein the openings are formed in the side wall of the reservoir.

9. A method according to claim 1 wherein a surgical opening is created to access an ethmoid sinus and wherein the reservoir is inserted, while in the non-expanded configuration, through that surgical opening and into the ethmoid sinus.

10. A method according to claim 1 wherein the reservoir is inserted, while in the non-expanded configuration, through or into an ostium of a frontal, maxillary or sphenoid sinus.

11. A method according to claim 1 wherein the shortening of the shaft so that the shaft does not protrude out of the patient'"'"'s nose occurs after the steroid has been introduced into the reservoir.

12. A method according to claim 1 wherein the reservoir remains in place for a period of days following introduction of the steroid into the reservoir.

13. A method according to claim 1 wherein the reservoir is constructed and the amount of steroid introduced is such that steroid will continue to pass through the openings of the reservoir at a rate that is effective to treat the sinusitis for 28 days.