IP Library Granted Patent US 12,636,422
Granted Patent B2
US 12,636,422 · App. 18/662,232 · Granted May 26, 2026

Sinus dilation catheter

Inventors: John R. Drontle (Buffalo, MN); Anthony J. Hanson (Chaska, MN); Paul Lesch (Lino Lakes, MN)
Assignee: Stryker Corporation
A61M1/76A61B17/24A61M25/01A61M29/02A61B2017/246A61M25/0032
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,636,422
App. No.
18/662,232
Granted
May 26, 2026
Kind
B2
Abstract

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess or maxillary sinus) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Claims (39)

1 . A balloon dilation device, comprising:

a handle having a proximal end and a distal end;

an inner guide member that extends distally from the distal end of the handle, wherein the inner guide member comprises a suction lumen extending from a proximal end of the inner guide member to a distal end of the inner guide member, wherein the handle comprises a suction vent port that is in fluid communication with the suction lumen of the inner guide member and operable to control a suction force at the distal end of the inner guide member;

a shaft defining a first lumen in which the inner guide member is disposed;

an inflatable balloon coupled to a distal portion of the shaft;

an inflation lumen that defines a fluid channel between (i) an inflation port coupled to the handle and (ii) an interior of the inflatable balloon;

a suction port coupled to the handle and configured to couple to a vacuum source,

a suction tube in the handle and extending proximally from the suction vent port; and

a valve seat in the handle, wherein the suction tube fluidly couples the suction vent port to the valve seat, wherein the valve seat comprises a valve that is configured to prevent aspirate collected at the distal end of the inner guide member from entering the suction tube.

2 . The balloon dilation device of claim 1 , wherein the inner guide member, the valve seat, the suction tube, the suction vent port, and the suction port are fluidly coupled such that a suction force is simultaneously produced at the distal end of the inner guide member and the suction vent port when a vacuum source applies suction to the suction port.

3 . The balloon dilation device of claim 1 , wherein the suction tube has a longitudinal axis that is parallel to a longitudinal axis of the inner guide member.

4 . The balloon dilation device of claim 1 , wherein the shaft is slidably arranged with respect to the inner guide member.

5 . The balloon dilation device of claim 4 , further comprising a shaft advancing member configured to move the shaft and the inflatable balloon along the inner guide member from a retracted state to an extended state.

6 . The balloon dilation device of claim 5 , wherein the shaft advancing member is moveable along a slot in a surface of the handle.

7 . The balloon dilation device of claim 6 , wherein the slot comprises a distal stop that prevents the shaft from advancing distally past a predetermined position relative to the inner guide member.

8 . The balloon dilation device of claim 7 , wherein the slot has a length of about one inch to about two inches.

9 . The balloon dilation device of claim 6 , wherein the shaft advancing member extends through the slot to couple the shaft advancing member to the shaft.

10 . The balloon dilation device of claim 5 , wherein the suction vent port is disposed in a surface of the handle that is proximal of the shaft advancing member.

11 . The balloon dilation device of claim 1 , wherein the inner guide member is formed from a stainless steel hypotube.

12 . The balloon dilation device of claim 1 , wherein the inflatable balloon is disposed about the inner guide member.

13 . The balloon dilation device of claim 1 , further comprising a support member defining a tube that is disposed about a periphery of the shaft, wherein the support member has a length that extends along at least a portion of the shaft.

14 . The balloon dilation device of claim 1 , wherein the inflation lumen comprises a looped portion that is configured to provide slack to the inflation lumen such that the inflatable balloon is movable between a retracted state and an extended state while maintaining the inflatable balloon in fluid communication with the inflation port, and

wherein the inflation lumen is folded back upon itself at the looped portion.

15 . The balloon dilation device of claim 14 , wherein the looped portion of the inflation lumen is in an interior space defined by the handle.

16 . The balloon dilation device of claim 1 , wherein the inflation port and the suction port are at the proximal end of the handle.

17 . A method of using a balloon dilation device comprising:

advancing a distal end of an inner guide member of the balloon dilation device transnasally to a sinus cavity, wherein the balloon dilation device comprises:

a handle having a proximal end and a distal end,

the inner guide member that extends distally from the distal end of the handle, wherein the inner guide member comprises a suction lumen extending from a proximal end of the inner guide member to a distal end of the inner guide member, wherein the handle comprises a suction vent port that is in fluid communication with the suction lumen of the inner guide member and operable to control a suction force at the distal end of the inner guide member,

a shaft defining a first lumen in which the inner guide member is disposed,

an inflatable balloon coupled to a distal portion of the shaft,

an inflation lumen that defines a fluid channel between (i) an inflation port coupled to the handle and (ii) an interior of the inflatable balloon,

a suction port coupled to the handle and configured to couple to a vacuum source, a suction tube in the handle and extending proximally from the suction vent port; and

a valve seat in the handle, wherein the suction tube fluidly couples the suction vent port to the valve seat, wherein the valve seat comprises a valve that is configured to prevent aspirate collected at the distal end of the inner guide member from entering the suction tube;

applying, using a vacuum source, suction to the suction port; and

while applying the suction to the suction port, occluding the suction vent port to increase an amount of suction at the distal end of the inner guide member.

18 . The method of claim 17 , wherein applying the suction to the suction port comprises simultaneously producing a suction force at the distal end of the inner guide member and the suction vent port.

19 . The method of claim 17 , wherein the suction tube has a longitudinal axis that is parallel to a longitudinal axis of the inner guide member.

20 . The method of claim 17 , further comprising preventing, by the valve, aspirate collected at the distal end of the inner guide member from entering the suction tube and the valve seat.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2025
From: ENTELLUS MEDICAL, INC.
To: STRYKER CORPORATION
Reel/Frame 069827/0553 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 16, 2024
From: DRONTLE, JOHN R.; HANSON, ANTHONY J.; LESCH, PAUL
To: ENTELLUS MEDICAL, INC.
Reel/Frame 067432/0339 →
Continuity (6)
Continuation 17479580 · Sep 20, 2021
Continuation 16393594 · Apr 24, 2019
Continuation 15290930 · Oct 11, 2016
Continuation 13535076 · Jun 27, 2012
Provisional Application 61502699 · Jun 29, 2011
Related Publication 20250345577A1 · Nov 13, 2025
References Cited (167)
US 2525183A · Robison · 1950 [cited by applicant]
US 3800788A · White · 1974 [cited by applicant]
US 4737141A · Spits · 1988 [cited by applicant]
US 5021043A · Becker et al. · 1991 [cited by applicant]
US 5024658A · Kozlov et al. · 1991 [cited by applicant]
US 5169386A · Becker et al. · 1992 [cited by applicant]
US 5391199A · Ben-Haim · 1995 [cited by applicant]
US 5415634A · Glynn et al. · 1995 [cited by applicant]
US 5443489A · Ben-Haim · 1995 [cited by applicant]
US 5466222A · Ressemann et al. · 1995 [cited by applicant]
US 5470315A · Adams · 1995 [cited by applicant]
US 5632762A · Myler · 1997 [cited by applicant]
US 5645628A · Thome · 1997 [cited by applicant]
US 5795325A · Valley et al. · 1998 [cited by applicant]
US 5964767A · Tapia et al. · 1999 [cited by applicant]
US 6083188A · Becker · 2000 [cited by applicant]
US 6090132A · Fox · 2000 [cited by applicant]
US 6113567A · Becker · 2000 [cited by applicant]
US 6238364B1 · Becker · 2001 [cited by applicant]
US 6491940B1 · Levin · 2002 [cited by applicant]
US 6543452B1 · Lavigne · 2003 [cited by applicant]
US D501677S · Becker · 2005 [cited by applicant]
US 6851424B2 · Scopton · 2005 [cited by applicant]
US 7520876B2 · Ressemann et al. · 2009 [cited by applicant]
US 7678099B2 · Ressemann et al. · 2010 [cited by applicant]
US 7842062B2 · Keith et al. · 2010 [cited by applicant]
US 7879061B2 · Keith et al. · 2011 [cited by applicant]
US 7918871B2 · Truitt et al. · 2011 [cited by applicant]
US 8241266B2 · Keith et al. · 2012 [cited by applicant]
US 8277478B2 · Drontle et al. · 2012 [cited by applicant]
US 8282667B2 · Drontle et al. · 2012 [cited by applicant]
US 8348969B2 · Keith et al. · 2013 [cited by applicant]
US 8568439B2 · Keith et al. · 2013 [cited by applicant]
US 8585728B2 · Keith et al. · 2013 [cited by applicant]
US 8585729B2 · Keith et al. · 2013 [cited by applicant]
US 8623043B1 · Keith et al. · 2014 [cited by applicant]
US 8657846B2 · Keith et al. · 2014 [cited by applicant]
US 8801670B2 · Drontle et al. · 2014 [cited by applicant]
US 8834513B2 · Hanson et al. · 2014 [cited by applicant]
US 8882795B2 · Drontle et al. · 2014 [cited by applicant]
US 8888686B2 · Drontel et al. · 2014 [cited by applicant]
US 8915938B2 · Keith et al. · 2014 [cited by applicant]
US 9005284B2 · Ressemann · 2015 [cited by applicant]
US 9101739B2 · Lesch, Jr. et al. · 2015 [cited by applicant]
US 9192748B2 · Ressemann et al. · 2015 [cited by applicant]
US 9278199B2 · Keith et al. · 2016 [cited by applicant]
US 9282986B2 · Hanson et al. · 2016 [cited by applicant]
US 9283360B2 · Lesch et al. · 2016 [cited by applicant]
US 9320876B2 · Ressemann et al. · 2016 [cited by applicant]
US 9333327B2 · Setliff, III et al. · 2016 [cited by applicant]
US 9339637B2 · Drontle et al. · 2016 [cited by applicant]
US 9370650B2 · Hanson et al. · 2016 [cited by applicant]
US 9433343B2 · Drontle et al. · 2016 [cited by applicant]
US 9440049B2 · Drontle et al. · 2016 [cited by applicant]
US 9486614B2 · Drontle et al. · 2016 [cited by applicant]
US 9550049B2 · Hanson et al. · 2017 [cited by applicant]
US 9694167B2 · Keith et al. · 2017 [cited by applicant]
US 9700705B2 · Lesch, Jr. et al. · 2017 [cited by applicant]
US 9775975B2 · Ressemann et al. · 2017 [cited by applicant]
US 10022525B2 · Hanson et al. · 2018 [cited by applicant]
US 10029069B2 · Keith et al. · 2018 [cited by applicant]
US 10086181B2 · Lesch et al. · 2018 [cited by applicant]
US 11147908B2 · Drontle · 2021 [cited by applicant]
US 11980708B2 · Drontle et al. · 2024 [cited by applicant]
US 20020065455A1 · Ben-Haim et al. · 2002 [cited by applicant]
US 20020138121A1 · Fox · 2002 [cited by applicant]
US 20040064083A1 · Becker · 2004 [cited by applicant]
US 20040064150A1 · Becker · 2004 [cited by applicant]
US 20040068299A1 · Laske et al. · 2004 [cited by applicant]
US 20050240147A1 · Makower et al. · 2005 [cited by applicant]
US 20050245906A1 · Makower et al. · 2005 [cited by applicant]
US 20060004286A1 · Chang et al. · 2006 [cited by applicant]
US 20060004323A1 · Chang et al. · 2006 [cited by applicant]
US 20060063973A1 · Makower et al. · 2006 [cited by applicant]
US 20060095066A1 · Chang et al. · 2006 [cited by applicant]
US 20060100687A1 · Fahey et al. · 2006 [cited by applicant]
US 20060106361A1 · Muni et al. · 2006 [cited by applicant]
US 20060149310A1 · Becker · 2006 [cited by applicant]
US 20060210605A1 · Chang et al. · 2006 [cited by applicant]
US 20060293612A1 · Jenson et al. · 2006 [cited by applicant]
US 20070005094A1 · Eaton et al. · 2007 [cited by applicant]
US 20070073269A1 · Becker · 2007 [cited by applicant]
US 20070135803A1 · Belson · 2007 [cited by applicant]
US 20070249896A1 · Goldfarb et al. · 2007 [cited by applicant]
US 20080015472A1 · Ressemann et al. · 2008 [cited by applicant]
US 20080015626A1 · Keith · 2008 [cited by applicant]
US 20080097154A1 · Makower et al. · 2008 [cited by applicant]
US 20080097295A1 · Makower et al. · 2008 [cited by applicant]
US 20080125626A1 · Chang et al. · 2008 [cited by applicant]
US 20080172033A1 · Keith et al. · 2008 [cited by applicant]
US 20080269596A1 · Revie et al. · 2008 [cited by applicant]
US 20090209972A1 · Loushin · 2009 [cited by examiner]
US 20090216196A1 · Drontle et al. · 2009 [cited by applicant]
US 20100030113A1 · Morriss et al. · 2010 [cited by applicant]
US 20100076269A1 · Makower · 2010 [cited by applicant]
US 20100211007A1 · Lesch et al. · 2010 [cited by applicant]
US 20100274222A1 · Setliff, III et al. · 2010 [cited by applicant]
US 20100312101A1 · Drontle · 2010 [cited by examiner]
US 20110071349A1 · Drontle et al. · 2011 [cited by applicant]
US 20110224652A1 · Drontle et al. · 2011 [cited by applicant]
US 20120010646A1 · Keith et al. · 2012 [cited by applicant]
US 20120071727A1 · Hanson et al. · 2012 [cited by applicant]
US 20120283625A1 · Keith et al. · 2012 [cited by applicant]
US 20130030459A1 · Drontle et al. · 2013 [cited by applicant]
US 20130041463A1 · Ressemann · 2013 [cited by applicant]
US 20130072958A1 · Ressemann et al. · 2013 [cited by applicant]
US 20130123833A1 · Lesch et al. · 2013 [cited by applicant]
US 20140350520A1 · Drontle et al. · 2014 [cited by applicant]
US 20140357959A1 · Hanson et al. · 2014 [cited by applicant]
US 20140364700A1 · Hanson et al. · 2014 [cited by applicant]
US 20140378776A1 · Hanson et al. · 2014 [cited by applicant]
US 20150031950A1 · Drontle et al. · 2015 [cited by applicant]
US 20150045827A1 · Drontle et al. · 2015 [cited by applicant]
US 20150105818A1 · Keith et al. · 2015 [cited by applicant]
US 20150352342A1 · Lesch et al. · 2015 [cited by applicant]
US 20160038726A1 · Hanson et al. · 2016 [cited by applicant]
US 20160151614A1 · Ressemnan et al. · 2016 [cited by applicant]
US 20160166814A1 · Lesch et al. · 2016 [cited by applicant]
US 20160367286A1 · Drontle et al. · 2016 [cited by applicant]
US 20170007282A1 · Drontle et al. · 2017 [cited by applicant]
US 20170050001A1 · Drontle et al. · 2017 [cited by applicant]
US 20170113027A1 · Drontle et al. · 2017 [cited by applicant]
US 20170368319A1 · Lesch, Jr. et al. · 2017 [cited by applicant]
US 20180008806A1 · Ressemann et al. · 2018 [cited by applicant]
US 20180304051A1 · Drontle et al. · 2018 [cited by applicant]
US 20180304058A1 · Hanson et al. · 2018 [cited by applicant]
EP 0129634A1 · 1985 [cited by applicant]
EP 159815A1 · 2005 [cited by applicant]
WO 91177787A1 · 1991 [cited by applicant]
WO 9600033A1 · 1996 [cited by applicant]
WO 2005086945A2 · 2005 [cited by applicant]
Iro, H., J. Zenk, “A new device for frontal sinus endoscopy: First Clinical Report”, Department of Otorhinolaryngology, University of Eralngen-Nuremberg, Germany. Otorhinolaryngology, Head and Neck Surgery vol. 125 No. … [cited by applicant]
Petersen, Robert J., Canine Fossa Puncture, The Laryngoscope Office, Oct. 5, 1972, pp. 369-371. [cited by applicant]
Elidan, J., MD., Irrigation of the Maxillary Sinus by Canine Fossa Puncture Experience with 202 Patients, Ann Otol Rhinol Laryngol, 92:1983, pp. 528-529. [cited by applicant]
Yanagisawa, Eiji, et al., Trans-Canine-Fossa Maxillary Sinoscopy for Biopsy Via the Stammberger Technique, ENT Rhinoscopic Clinic, Aug. 2001 Rhino, pp. 1-3. [cited by applicant]
Yanagisawa, Eiji, et al., Powered Endoscopic Inferior Meatal Antrostomy Under Canine Fossa Telescopic Guidance, ENT-Ear, Nose & Throat Journal, Sep. 2001, pp. 618-620. [cited by applicant]
Sathananthar, Shanmugam, et al., Canine Fossa Puncture and Clearance of the Maxillary Sinus for the Severely Diseased Maxillary Sinus, The Laryngoscope 115: Jun. 2005, pp. 1026-1029. [cited by applicant]
Robinson, Simon, et al., Patterns of Innervation of the Anterior Maxilla: A Cadaver Study with Relevance to Canine Fossa Puncture of the Maxillary Sinus, Laryngoscope 115: Oct. 2005, pp. 1785-1788. [cited by applicant]
Bolger, William, E., et al., Catheter-Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model, Maryland Sinus Clinic, Bethesda, Maryland, and California Sinus Institute, Palo Alto, … [cited by applicant]
Friedman, Michael, M.D. et al., Functional Endoscopic Dilatation of the Sinuses (FEDS): Patient Selection and Surgical Technique, Operative Technologies in Otolaryngology, vol. 17, No. 2, Jun. 2006, pp. 126-134. [cited by applicant]
Jones, Nick, Commentary on “Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation”, Annals of Otology, Rhinology & Laryngology 115(4), pp. 300-301 (2006). [cited by applicant]
Bolger, William E., Commentary Misconceptions Regarding Balloon Catheter Dilation of Paranasal Sinus Ostia, Annals of Otology, Rhinology & Laryngology 115(10): 791-792 (2006). [cited by applicant]
Lanza, Donald, C., et al., Commentary Balloon Sinuplasty: Not Ready for Prime Time, Annals of Otology, Rhinology & Laryngology 115(10): 789-790 (2006). [cited by applicant]
Brown, Christopher, L., et al., “Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation”, Annals of Otology, Rhinology & Laryngology 115(4): 293-299 (2006). [cited by applicant]
Gottman, D., et al., “Balloon Dilatation of Recurrent Ostia Occlusion of the Frontal Sinus”, ECR Mar. 3, 2001, 2:-3:30 PM, Vienna Austria (1 page). [cited by applicant]
Entellus Medical, 510(k) Premarket Notification cover letter and Attachment B: Predicate Device Labeling, dated Aug. 15, 2007. [cited by applicant]
R. Peterson, Sinus Puncture Therreapy: Canine Fossa Puncture Method “How I Do It” Head and Neck, The Larynsgoscope 91: Dec. 1981, pp. 2126-2128. [cited by applicant]
T.G.A. Ijaduola, Use of a Foley Catheter for Short-Term Drainage of Frontal Sinus Surgery, Journ. of Laryngology and Otology, Apr. 1989, vol. 103, pp. 375-378. [cited by applicant]
A. Gatot et al., Early Treatment of Oribilal Floor Fractures with Catheter Balloon in Children, Int'l. J. of Ped. Otorhinolaryngology, 21 (1991) 97-101. [cited by applicant]
D.I. Tarasov et al., Treatment of Chronic Ethmoiditis by IntraCellular Administration of Medicines to the Ethmoidal Labyrinth, Vestn Otorinolaringol. Nov.-Dec. 1978; (6):45-47 (Abstract in English). [cited by applicant]
J.M. Robison, Pressure Treatment of Maxillary Sinusitis, J.A.M.A., May 31, 1952, pp. 436-440. [cited by applicant]
J.M. Robison, Pressure Treatment of Purulent Maxillary Sinusitis, Texas State Journal of Medicine, May 1952, pp. 281-288. [cited by applicant]
Entellus Medical, 510(k) Letter (Amendment 1) and Attachment D&E, dated Mar. 13, 2008. [cited by applicant]
Gottman et al., Balloon Dilation of Recurrent Ostial Occlusion of the Frontal Sinus, Gottman et al.: Abstract (B-0453) Mar. 2001, 22 pages. [cited by applicant]
PCT International Search Report for PCT/US2007/088834, Applicant: Entellus Medical, Inc., Forms PCT/ISA/220 and PCT/ISA/210, dated May 20, 2008 (4 pages). [cited by applicant]
PCT Written Opinion for PCT/US2007/088834, Applicant: Entellus Medical, Inc., Form PCT/ISA/237, dated May 20, 2008 (10 pages). [cited by applicant]
PCT International Search Report for PCT/US2007/66187, Applicant: Entellus Medical, Inc., Forms PCT/ISA/220 and PCT/ISA/210, dated Apr. 17, 2008 (5 pages). [cited by applicant]
PCT Written Opinion for PCT/US2007/66187, Applicant: Entellus Medical, Inc., Form PCT/ISA/237, dated Apr. 17, 2008 (5 pages). [cited by applicant]
Folweiler, David S., Nasal Specific Technique as Part of a Chropractic Approach to Chronic Sinusitis and Sinus Headaches, Journal of Manipulative and Physiological Therapeutics, vol. 18, No. 1 (Jan. 1995). [cited by applicant]
PCT International Preliminary Report on Patentability (Chapter I of the Patent Cooperation Treaty) of the International Bureau for PCT/US2007/066187, Applicant: Entellus Medical, Inc., Form PCT/IB/326, dated Oct. 30, 20… [cited by applicant]
Medtronic, ENT Image-Guided Surgery System, http://www.xomed.com/xomed_products_element.html, Jun. 3, 2009 (2 pages). [cited by applicant]
International Search Report dated Aug. 2, 2010, for PCT/US2010/037508, Applicant: Entellus Medical, Inc. (4 pages). [cited by applicant]
Written Opinion of the International Search Authority dated Aug. 2, 2010, for PCT/US2010/037508, Applicant: Entellus Medical, Inc. (4 pages). [cited by applicant]
International Preliminary Report on Patentability dated Jul. 30, 2009, for PCT/US2007/088834, Applicant: Entellus Medical, Inc. (9 pages). [cited by applicant]
PCT International Preliminary Report on Patentability (Chapter I of the Patent Cooperation Treaty) for PCT/US2010/037508, Applicant: Entellus Medical Inc., Forms PCT/IB/326 and 373, dated Dec. 15, 2011 (6pages). [cited by applicant]
Gould, James D., In-Office Balloon Dilation: Procedure Techniques and Outcomes using a Malleable Multi-Sinus Dilation Tool, undated, (5pages). [cited by applicant]
Joe, John K, Anterior and posterior nasal fontanelles, Jan. 1, 2001 (3pages). [cited by applicant]