Frontal sinus spacer

• US 8,764,729 B2
• Filed: 12/22/2008
• Issued: 07/01/2014
• 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., Chan, Randy S., Van, Nga K.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US12/341,602
• Publication Number:
  US 20090198216A1
• Time in Patent Office: 2,017 Days
• Field of Search: 604/500, 604508-510, 604/514, 604/516, 606/196, 424/434
• 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 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 device deploy to retain the sinus spacer device in the paranasal sinus;

after advancing the substance delivery sinus spacer device, introducing a substance into a substance eluting reservoir of the sinus spacer device so that the substance elutes from the reservoir through multiple apertures;

separating the sinus spacer device from the catheter; and

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

2. The method of claim 1, wherein the guide device, the sinus spacer device and the catheter are advanced into the nostril together, and wherein the sinus spacer device is then advanced out of the distal end of the guide device.

3. The method of claim 1, wherein introducing the substance comprises introducing a steroid.

4. The method of claim 3, wherein introducing the steroid comprises introducing triamcinalone acetonide.

5. The method of claim 1, wherein the substance is in the form of a suspension and wherein the method further comprises adding additional liquid to the reservoir.

6. The method of claim 1, wherein introducing the substance into the reservoir causes the reservoir to expand.

7. The method of claim 1, wherein the sinus spacer device and the substance are delivered to a frontal paranasal sinus.

8. The method of claim 1, wherein the sinus spacer device and the substance are delivered to a maxillary paranasal sinus.

9. The method of claim 1, wherein the sinus spacer device and the substance are delivered to a sphenoid paranasal sinus.

10. The method of claim 1, wherein the sinus spacer device and the substance are delivered to a ethmoid paranasal sinus.

11. The method of claim 1, wherein the sinus spacer device is left behind in the paranasal sinus for a period of between seven and ninety days, the method further comprising removing the sinus spacer device from the paranasal sinus.

12. The method of claim 1, further comprising attaching the sinus spacer device to mucosal tissue using a suture loop coupled with the sinus spacer device.

13. The method of claim 1, wherein separating the sinus spacer device from the catheter comprises cutting at or near a junction of the sinus spacer device and the catheter.

14. The method of claim 1, further comprising attaching a handle to the guide device before advancing the guide device into the nostril.