# US 11,433,221 B2 · Devices and method for maxillary sinus lavage > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,221 B2 - Document ID: US11433221B2 - Status: Granted - Kind: B2 - Application number: 16/266,554 - Filed: 2019-02-04 - Published: 2019-07-25 - Granted: 2022-09-06 - Earliest claimed: 2012-04-13 - Assignees: Acclarent, Inc. - Applicants: Acclarent, Inc. - Inventors: Thomas R. Jenkins; Jessica Liberatore; Sandra W. Ruggles; Jessica K. Chan - Web page: https://patentgrep.com/patent/US11433221B2 ## CPC - A61M 25/0147: {with movable mechanical means, e.g. pull wires} - A61B 1/07: using light-conductive means, e.g. optical fibres - A61M 3/0279: {Cannula; Nozzles; Tips; their connection means} - A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure} - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) - A61M 25/0152: {with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes} - A61B 1/233: for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes} - A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)} - A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers} - A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system} - A61M 2025/0006: {which can be secured against axial movement, e.g. by using a locking cuff} - A61M 2025/0175: {having telescopic features, interengaging nestable members movable in relations to one another} - A61M 2210/0681: Sinus (maxillaris) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A lavage catheter for the treatment of a maxillary sinus is described. The catheter comprises a proximal portion and a distal portion. The distal portion comprises an irrigation tip. The irrigation tip has a tip opening through which fluid may be delivered by one handed operation of the catheter. A method for lavaging the maxillary sinus includes inserting the lavage catheter into a patient's anatomy and advancing the irrigation tip into the maxillary sinus using one hand. ## Claims ### Claim 1 A method for lavaging a paranasal sinus of a patient, the method comprising: (a) providing a lavage catheter instrument comprising: (i) a malleable elongate shaft formed from a malleable material, (ii) a distal irrigation tube in coaxial arrangement with and coupled with the malleable elongate shaft, wherein the distal irrigation tube includes at least one irrigation hole, (iii) a hub disposed proximal to both the malleable elongate shaft and the distal irrigation tube, (iv) a proximal irrigation tube having a proximal end and a distal end, wherein the distal end of the proximal irrigation tube connects to a proximal end of the malleable elongate shaft and the distal irrigation tube, and (v) a luer connector coupled with the proximal end of the proximal irrigation tube, wherein the luer connector is configured to be coupled with a syringe to provide irrigation fluid for lavage of the paranasal sinus; (b) shaping the malleable elongate shaft prior to inserting the lavage catheter instrument into the patient; (c) fluidly coupling the syringe to the luer connector of the lavage catheter instrument; (d) positioning distal portions of the malleable elongate shaft and the proximal irrigation tube within the paranasal sinus of the patient under visual guidance of an endoscope; and (e) delivering the irrigation fluid in pulses from the syringe and through the at least one irrigation hole to lavage the paranasal sinus. ### Claim 2 (depends on 1) The method of claim 1, wherein delivering the irrigation fluid to the paranasal sinus is performed under visual guidance of the endoscope. ### Claim 3 (depends on 1) The method of claim 1, wherein delivering the fluid further comprises manually moving a hand pushable plunger of the syringe to eject the fluid through the syringe. ### Claim 4 (depends on 1) The method of claim 1, wherein the delivering of the irrigation fluid occurs at a flow rate of between 50 ml/min and 250 ml/min. ### Claim 5 (depends on 1) The method of claim 1, wherein shaping the malleable elongate shaft further comprises shaping the malleable elongate shaft to have a bend angle of between about 90 degrees and 140 degrees. ### Claim 6 (depends on 1) The method of claim 1, wherein the at least one irrigation hole includes a plurality of radially facing irrigation holes allowing the irrigation fluid to spray in all directions to clean the paranasal sinus. ### Claim 7 (depends on 1) The method of claim 1, wherein the distal irrigation tube has two lumens, where a first lumen of the distal irrigation tube carries irrigation fluid from the syringe to the at least one irrigation hole. ### Claim 8 (depends on 1) The method of claim 1, wherein the syringe has a volume of about 10 cc to about 60 cc. ### Claim 9 (depends on 8) The method of claim 8, wherein the syringe has a volume of 60 cc. ### Claim 10 (depends on 1) The method of claim 1, wherein the irrigation fluid is selected from the group consisting of water, saline, contrast agents, antimicrobial agents, anti-inflammatory agents, decongestants, mucous thinning agents, anesthetic agents, analgesic agents, antiallergenic agents, allergens, anti-proliferative agents, hemostatic agents, cytotoxic agents, and biological agents or combinations of any of the above. ### Claim 11 (depends on 1) The method of claim 1, wherein the method further comprises viewing one or more direct visualization markers to ensure proper placement of the lavage catheter instrument. ### Claim 12 (depends on 1) The method of claim 1, further comprising viewing one or more direct visualization markers with the naked eye or with the endoscope. ### Claim 13 (depends on 1) The method of claim 1, wherein the paranasal sinus comprises a maxillary sinus. ### Claim 14 (depends on 1) The method of claim 1, wherein the malleable material is annealed stainless steel, wherein shaping the malleable elongate shaft further comprises shaping the annealed stainless steel to access a maxillary sinus. ### Claim 15 A method for lavaging a paranasal sinus of a patient, the method comprising: (a) providing a lavage catheter instrument comprising: (i) a malleable elongate shaft formed from a malleable material, (ii) a distal irrigation tube in coaxial arrangement with the malleable elongate shaft, wherein the distal irrigation tube includes at least one irrigation hole, wherein the distal irrigation tube has first and second lumens, (iii) a hub disposed proximal to both the malleable elongate shaft and the distal irrigation tube, (iv) a proximal irrigation tube having a proximal end and a distal end, wherein the distal end of the proximal irrigation tube connects to a proximal end of the malleable elongate shaft and the distal irrigation tube, and (v) a luer connector coupled with the proximal end of the proximal irrigation tube, wherein the luer connector is configured to be coupled with a syringe to provide irrigation fluid for lavage of the paranasal sinus; (b) shaping the malleable elongate shaft prior to inserting the lavage catheter instrument into the patient; (c) fluidly coupling a fluid reservoir with the hub of the lavage catheter instrument; (d) fluidly coupling the syringe to the luer connector of the lavage catheter instrument; (e) positioning distal portions of the malleable elongate shaft and the proximal irrigation tube within the paranasal sinus of the patient; (f) delivering the irrigation fluid from the syringe, through the first lumen, and through the at least one irrigation hole to lavage the paranasal sinus; and (g) suctioning the paranasal sinus to remove the irrigation fluid. ### Claim 16 (depends on 15) The method of claim 15, wherein delivering the irrigation fluid from the syringe to the paranasal sinus is performed under visual guidance of an endoscope. ### Claim 17 (depends on 15) The method of claim 15, wherein delivering the irrigation fluid further comprises manually moving a hand pushable plunger of the syringe to eject the irrigation fluid. ### Claim 18 (depends on 15) The method of claim 15, wherein delivering the irrigation fluid further comprises delivering the irrigation fluid in pulses from the syringe and through the single irrigation hole to lavage the paranasal sinus. ### Claim 19 A method for lavaging a paranasal sinus of a patient, the method comprising: (a) providing a lavage catheter instrument comprising: (i) a malleable elongate shaft formed from a malleable material, (ii) a distal irrigation tube in coaxial arrangement with the malleable elongate shaft, the distal irrigation tube comprising: (A) an outer surface, (B) at least one irrigation hole, and (C) a plurality of direct visualization markers disposed on the outer surface, (iii) a hub disposed proximal to both the malleable elongate shaft and the distal irrigation tube, (iv) a proximal irrigation tube having a proximal end and a distal end, wherein the distal end of the proximal irrigation tube connects to a proximal end of the malleable elongate shaft and the distal irrigation tube, and (v) a luer connector coupled with the proximal end of the proximal irrigation tube, wherein the luer connector is configured to be coupled with a syringe to provide irrigation fluid for lavage of the paranasal sinus; (b) shaping the malleable elongate shaft prior to inserting the lavage catheter instrument into the patient; (c) fluidly coupling the syringe to the luer connector of the lavage catheter instrument; (d) positioning distal portions of the malleable elongate shaft and the proximal irrigation tube within the paranasal sinus of the patient by viewing the plurality of direct visualization markers disposed on the outer surface using an endoscope; and (e) delivering the irrigation fluid from the syringe and through the at least one irrigation hole to lavage the paranasal sinus. ### Claim 20 (depends on 19) The method of claim 19, wherein the distal irrigation tube has two lumens, where a first lumen of the distal irrigation tube carries irrigation fluid from the syringe to the at least one irrigation hole.