Devices and methods for treating maxillary sinus disease

• US 9,351,750 B2
• Filed: 12/16/2009
• Issued: 05/31/2016
• 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., Harfe, Daniel T., Levine, Howard
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/639,919
• Publication Number:
  US 20110112512A1
• Time in Patent Office: 2,358 Days
• Field of Search: 604/500, 604508-510, 604/514, 604/516, 604/101.05, 604/890.1, 604/174, 604/99.02, 604/99.04, 606/196, 424/434, 128/204.12
• US Class Current: 1/1
• 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 system useable for treating a disorder of a maxillary sinus, the system comprising a sinus spacer device that comprises:

(a) an elongate shaft having a lumen, a proximal end and a distal end,

(b) an expandable reservoir insertable into a paranasal sinus and 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 size that is greater than the size of a paranasal ostium, wherein a sidewall of the reservoir comprises a plurality of openings configured to allow a substance that has been introduced into the reservoir to exit the reservoir into the maxillary sinus via the openings, and

(c) a collapsible retention structure insertable into a paranasal sinus and biased to expand from a collapsed orientation to an expanded orientation to thereby prevent slipping of the reservoir outwardly from a paranasal ostium.

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

(a) a sinus spacer device insertable into a paranasal ostium, comprising;

(i) an elongate shaft having a lumen, a proximal end and a distal end,

(ii) 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 size that is greater than the size of a paranasal ostium, and

(iii) a collapsible retention structure biased to expand from a collapsed orientation to an expanded orientation to thereby prevent slipping of the reservoir outwardly from a paranasal ostium, wherein the collapsible retention structure comprises a proximal end and a distal end, wherein the distal end of the collapsible retention structure is configured to deflect outwardly away from the elongate shaft to thereby prevent slipping of the reservoir from the paranasal ostium, wherein the proximal end of the collapsible retention structure is configured to remain in contact with the elongate shaft as the distal end of the collapsible retention structure deflects outwardly; and

(b) a tubular delivery guide having a lumen through which the spacer device is insertable, wherein the tubular delivery guide is configured to constrain the collapsible retention structure in the collapsed orientation as the sinus spacer device is inserted into a paranasal ostium.

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

(a) a sinus spacer device, comprising;

(i) an elongate shaft having a lumen, a proximal end and a distal end, wherein the elongate shaft comprises a valve member,

(ii) 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 size that is greater than the size of a paranasal ostium, wherein the expandable reservoir is positioned about the elongate shaft such that the valve member of the elongate shaft is disposed within the expandable reservoir, wherein the valve member is configured to regulate the flow of the substance into the expandable reservoir, and

(iii) a collapsible retention structure insertable into a paranasal sinus between the expandable reservoir and a paranasal ostium, wherein the collapsible retention structure is biased to expand from a collapsed orientation to an expanded orientation to thereby prevent slipping of the reservoir outwardly from a paranasal ostium; and

(b) an elongate shaft having a lumen through which the spacer device is insertable.