US20230381457A1 - Devices and method for maxillary sinus lavage - Google Patents

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.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This patent application is a continuation of U.S. patent application Ser. No. 17/892,538 filed Aug. 22, 2022 and published as U.S. Publication No. 2022/0401698, which is a continuation of U.S. patent application Ser. No. 16/266,554 filed Feb. 4, 2019 and issued as U.S. Pat. No. 11,433,221 on Sep. 6, 2022, which is a continuation of U.S. patent application Ser. No. 16/190,227 filed Nov. 14, 2018 and issued as U.S. Pat. No. 11,167,109 on Nov. 9, 2021, which is a continuation of U.S. patent Application No. filed Oct. 18, 2017 and issued as U.S. Pat. No. 10,166,369 on Jan. 1, 2019, which is a continuation of U.S. patent application Ser. No. 13/800,163 filed on Mar. 13, 2013 and published as U.S. Patent Publication No. 2013/0274600 on Oct. 17, 2013, now abandoned, which claims priority to U.S. Patent Application No. 61/675,595 filed on Jul. 25, 2012 and also claims priority to U.S. Patent Application No. 61/623,730 filed on Apr. 13, 2012, the entire disclosures of which are expressly incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention relates, in general, to medical devices and, in particular, to medical devices and related methods for the treatment of sinus conditions.
BACKGROUND OF THE INVENTION
• The paranasal sinuses are hollow cavities in the skull connected by small openings, known as ostia, to the nasal canal. Each ostium between a paranasal sinus and the nasal cavity is formed by a bone covered by a layer of mucosal tissue. Normally, air passes into and out of the paranasal sinuses through the ostia. Also, mucus is continually formed by the mucosal lining of the sinuses and drains through the ostia and into the nasal canal.
• Sinusitis is a general term that refers to inflammation in one or more of the paranasal sinuses. Acute sinusitis can be associated with upper respiratory infections or allergic conditions, which may cause tissue swelling and temporarily impede normal trans-ostial drainage and ventilation of the sinuses, thereby resulting in some collection of mucus and possibly infection within the sinus cavities. Chronic sinusitis is a long term condition characterized by persistent narrowing or blockage of one or more sinus ostia, resulting in chronic infection and inflammation of the sinuses. Chronic sinusitis is often associated with longstanding respiratory allergies, nasal polyps, hypertrophic nasal turbinates and/or deviated internasal septum. While acute sinusitis is typically caused by infection with a single pathogen (e.g., one type of bacteria, one type of virus, one type of fungus, etc.), chronic sinusitis is often associated with multiple pathogen infections (e.g., more than one type of bacteria or more than one genus of micro-organism).
• Chronic sinusitis, if left untreated, can result in irreparable damage to the tissues and/or bony structures of the paranasal anatomy. The initial treatment of chronic sinusitis usually involves the use of drugs such as decongestants, steroid nasal sprays and antibiotics (if the infection is bacterial). In cases where drug treatment alone fails to provide permanent relief, surgical intervention may be indicated.
• The most common surgical procedure for treating chronic sinusitis is functional endoscopic sinus surgery (FESS). FESS is commonly performed using an endoscope and various rigid instruments inserted through the patient's nostril. The endoscope is used to visualize the positioning and use of various rigid instruments used for removing tissue from the nasal cavity and sinus ostia in an attempt to improve sinus drainage.
• A technique known as the Balloon Sinuplasty™ procedure and a system for performing the procedure has been developed by Acclarent Inc, of Menlo Park, CA for treatment of sinusitis. A number of US patents and patent applications including U.S. Pat. Nos. 7,645,272, 7,654,997, and 7,803,150 describe various embodiments of the Balloon Sinuplasty™ procedure as well as various devices useable in the performance of such procedure. In the Balloon Sinuplasty™ procedure, a guide catheter is inserted into the nose and positioned within or adjacent to the ostium of the affected paranasal sinus. A guidewire is then advanced through the guide catheter and into the affected paranasal sinus. Thereafter, a dilation catheter having an expandable dilator (e.g. an inflatable balloon) is advanced over the guidewire to a position where the dilator is positioned within the ostium of the affected paranasal sinus. The dilator is then expanded, causing dilation of the ostium and remodelling of bone adjacent to the ostium, without required incision of the mucosa or removal of any bone. The catheters and guidewire are then removed and the dilated ostium allows for improved drainage from and ventilation of the affected paranasal sinus.
• Before or after performing a FESS or Balloon Sinuplasty™ procedure, it may be useful or necessary to irrigate the paranasal sinus. A device described in US2008/0183128, now abandoned, may be used for irrigating a paranasal sinus. The irrigation catheter may be advanced through a guide catheter and into an ostium or the sinus for purposes of, for example irrigation, suctioning, substance delivery and culture retrieval.
• There is a continuing need for improved methods and devices for treating the paranasal sinus. Although the irrigation catheter described above is easy to use, it would be useful to provide an improved catheter for irrigating the maxillary sinuses.
SUMMARY OF THE INVENTION
• In a first aspect, the invention is a catheter for the lavage of a maxillary sinus comprising a distal portion having an elongate shaft with a bend angle of between about 90 degrees and 140 degrees. The lavage catheter distal portion further has a distal irrigation tube that is in coaxial arrangement with the elongate shaft. An actuator that is located between a distal hub and a proximal hub is used for advancing the distal irrigation tube into the maxillary sinus. The lavage catheter further includes a proximal portion with an irrigation luer and irrigation tubing.
• In one embodiment of the lavage catheter, the irrigation tip has a distal tip opening.
• In another embodiment, the irrigation tip has and one or more radially facing openings.
• In another embodiment the distal irrigation tube is a flexible material selected from the group consisting of nylon, polyethylene, polyether ether ketone or polyether block amides.
• In a further embodiment, the distal irrigation tube is a polyether block amide.
• In still another embodiment, the lavage catheter includes one or more direct visualization markers.
• In another embodiment, the lavage catheter includes one or more radiographic markers.
• In a further embodiment, the distal irrigation tube surrounds the elongate shaft.
• In yet a further embodiment, the distal irrigation tube is surrounded by the elongate shaft.
• In still another embodiment, the lavage catheter comprises an illuminating fiber.
• In another embodiment, the distal irrigation tip has a tapered configuration.
• In another aspect, the invention is a catheter for the lavage of a maxillary sinus. The catheter includes a distal portion and a proximal portion. The distal portion in includes an elongate shaft with a bend angle of between about 90 degrees and 140 degrees, a distal irrigation tube in coaxial arrangement with the elongate shaft, and a handle with an actuator. The proximal portion of the catheter has an irrigation luer and irrigation tubing. The actuator is useful for advancing the distal irrigation tube into the maxillary sinus.
• In one embodiment, the actuator has a light access port and the distal portion of the catheter includes an illuminating fiber.
• In another aspect, the invention is a kit for the lavage of a maxillary sinus. The kit includes a catheter and an endoscope. The catheter includes a distal portion and a proximal portion. The distal portion has an elongate shaft with a bend angle of between about 90 degrees and 140 degrees, a distal irrigation tube coaxially arranged with the elongate shaft, an illuminating fiber, and a handle with an actuator. The actuator has a light access port for insertion of the endoscope. The actuator is useful for advancing the distal irrigation tube into the maxillary sinus. The proximal portion of the catheter has an irrigation luer and irrigation tubing,
• In another aspect, the invention includes a method for lavaging a maxillary sinus. The method includes positioning a lavage catheter comprising a proximal portion, and a distal portion in the nasal anatomy. The distal portion comprises an irrigation tip. The method further includes connecting a fluid source to the irrigation catheter; with one hand, advancing the irrigation tip into the maxillary sinus; and delivering fluid to the maxillary sinus from the fluid source though the lavage catheter.
• In a further embodiment, the method includes delivering the fluid at a flow rate of between 50 ml/min and 250 ml/min.
• In yet another embodiment, the delivered 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, anti-allergenic agents, allergens, anti-proliferative agents, hemostatic agents, cytotoxic agents, and biological agents or combinations of any of the above.
• In another aspect, the invention is directed to a kit for the lavage of a maxillary sinus. The kit comprises a maxillary lavage catheter and a illuminating fiber connector. The catheter comprises a distal portion and a proximal portion. The catheter distal portion comprises an elongate shaft with a bend angle of between about 90 degrees and 140 degrees, a distal irrigation tube in coaxial arrangement with said elongate shaft, an illuminating fiber, and a handle. The handle comprises an actuator. The catheter proximal portion comprises an irrigation luer and irrigation tubing. The actuator is useful for advancing the distal irrigation tube into the maxillary sinus. The illuminating fiber connector connects the illuminating fiber to a light source, wherein the illuminating fiber connector allows for rotation of the catheter while the catheter is connected to the light source.
• In another aspect, the invention is directed to a kit for the lavage of a maxillary sinus. The kit comprises a catheter and fluid delivery system. The catheter comprises a distal portion and a proximal portion. The distal portion comprises an elongate shaft with a bend angle of between about 90 degrees and 140 degrees, a distal irrigation tube in coaxial arrangement with the elongate shaft, an illuminating fiber, and a handle comprising an actuator. The proximal portion comprises an irrigation luer and irrigation tubing. The actuator is useful for advancing the distal irrigation tube into the maxillary sinus. The fluid delivery system provides for continuous fluid delivery to the catheter.
• In a further embodiment, the fluid delivery system comprises a syringe, a fluid reservoir, a first one-way valve for directing fluid from the syringe into the catheter when pressure is applied to the syringe and a second one-way valve for directing fluid from the fluid reservoir into the catheter when pressure is released from the syringe.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG.1 is a side view of a medical device according to an embodiment of the present invention in a retracted configuration.
• FIG.2 is a side view of the medical device ofFIG.1 in an extended configuration.
• FIG.3 is a side view of a further embodiment of the medical device according to the invention.
• FIG.4 is an enlarged view of the distal portion of the medical device ofFIG.3 in an extended configuration.
• FIG.5 is a side view of yet another embodiment of the medical device according to the invention.
• FIG.6 is an enlarged view of the distal end of the medical device ofFIG.5 according to the invention.
• FIG.7 is a top view of still another embodiment of the medical device according to the invention.
• FIG.8 is a top view of yet another embodiment of the medical device according to the invention.
• FIG.9 is a schematic diagram of a continuous fluid injection system for use with the medical device according to the invention.
• FIG.10A is a light cable connector for use in connecting a light cable to the medical device according to the invention.
• FIG.10B is a side cut-away view of the light cable connector ofFIG.10A.
DETAILED DESCRIPTION
• The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict exemplary embodiments for the purpose of explanation only and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
• As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.
• Medical devices according to embodiments of the present invention are beneficial in that, for example, their configuration provides for a particularly efficient preparation and treatment of a patient's sinus and is mechanically simple. Moreover, the simplicity of the medical devices provides for them to be manufactured in a cost effective manner. In addition, the medical device according to embodiments of the present invention is sufficiently stiff that it can be beneficially employed to access sinus anatomy followed by a convenient suction and/or irrigation of the sinus.
• FIG.1 is a side view of amaxillary lavage catheter100 according to an embodiment of the present invention. Themaxillary lavage catheter100 has adistal portion102 and aproximal portion106.
• Thedistal portion102 in the embodiment shown inFIG.1 includes anelongate shaft108 with sufficient stiffness to access the maxillary sinus that further includes adistal end110 and aproximal end112. Thedistal end110 of theelongate shaft108 has a bend angle that is optimal for access to the maxillary sinus such that it can be maneuvered to access behind the uncinate process. Accordingly, the bend angle is between about 90° and 140°, often between about 100° and 130° and often about 110° or about 120°. The elongate shaft may be of any material that will maintain its shape when inserted into the patient's anatomy including but not limited to a polymeric material selected from the group including but not limited to nylon, polycarbonate, and styrene, or a biocompatible metal including but not limited to stainless steel, but will often be a stainless steel hypotube that may or may not be coated or colored, often in black, white or blue. Alternatively, theelongate shaft108 may be made of a malleable material including but not limited to annealed stainless steel that can be shaped appropriately for accessing the maxillary sinus.
• Thedistal portion102 of themaxillary lavage catheter100 additionally includes adistal irrigation tube114 that is in coaxial arrangementelongate shaft108. In the embodiment shown inFIG.1, thedistal irrigation tube114 surrounds theelongate shaft108, but in an alternative embodiment, thedistal irrigation tube114 may be surrounded by theelongate shaft108. Thedistal irrigation tube114 may be of any flexible material that can be used to extend into the maxillary sinus as will be described further below, including but not limited to a flexible, biocompatible polymer material, such as nylon, polyethylene, polyether ether ketone (PEEK), or polyether block amides (e.g. Pebax for example) and that may be braided or not braided. In the embodiment shown inFIG.1, the material is Pebax.
• Thedistal end110 of thedistal irrigation tube114 includes a soft,atraumatic tip118. The softatraumatic tip118 may be of a low durometer pebax material and it may be of tapered construction for easy access into the maxillary sinus. Theatraumatic tip118 may further have one or more radially facing openings to facilitate irrigation, often one, two or three openings of between about 0.5 to about 1.5 mm, often between about 0.8 and 1.0 mm. Thelavage catheter100 is designed to irrigate the sinus through theatraumatic tip118 at a flow rate of between about 50 ml/min and 250 ml/min and often between about 75 ml/min and 125 ml/min. The diameter of theopening212 of the atraumatic tip is between about 0.5 mm and 1.5 mm, and is often between about 0.9 mm and 1.0 mm. Further, instead of delivering fluid, a vacuum may be applied and a culture may be obtained by suctioning through theatraumatic tip118.
• Thedistal portion102 of themaxillary lavage catheter100 additionally includes aproximal hub132 and adistal hub136. Between theproximal hub132 and thedistal hub136 are stiffeningelements138 and140, and anactuator142. Theactuator142 has aproximal end150 and adistal end152. Theproximal end112 of theelongate shaft108 extends through theproximal hub132 and connects to thedistal end122 of theproximal irrigation tube120. Theproximal end115 of thedistal irrigation tube114 is connected to thedistal end152 of theactuator142. The stiffeningelements138 and140 extend from the proximal end of thedistal hub136 through theactuator142 to thedistal end160 orproximal hub132. As shown inFIG.1, when theproximal irrigation tube120 is fully retracted, theproximal end150 ofactuator142 is adjacent to thedistal end160 of theproximal hub132.
• Thedistal hub136 andproximal hub132 are configured for one-handed operation of themaxillary lavage catheter100. Thenarrow portion170 of thedistal hub136 may be for grasped while theridge172 on theactuator142 is pushed toward thedistal hub136 with the thumb. Alternatively, thenarrow portion170 of thedistal hub136 is may be grasped by the thumb and one or more fingers while theridge172 on theactuator142 can be drawn toward thedistal hub136 with one finger. In this way, as is shown inFIG.2, thedistal irrigation tube114 is extended beyond thedistal end110 of theelongate shaft108 and into the maxillary sinus. Similarly, removal from the nasal anatomy can be effected by the thumb or single finger of the physician user as pressure is applied on theridge172, pushing it away from the nasal anatomy, retracting thedistal irrigation tube114 and the removing the maxillary lavage catheter from the nasal anatomy. In an alternative embodiment, a spring may be included to automatically retract thedistal irrigation tube114 following irrigation of the maxillary sinus. Although the embodiments shown inFIGS.1 and2 shown thedistal irrigation tube114 coaxially surrounding theelongate shaft108, contemplated herein is also a configuration where in the irrigation tubeelongate shaft108 coaxially surrounds thedistal irrigation tube114.
• Another embodiment of themaxillary lavage catheter800 according to the invention is shown inFIG.8 having adistal portion802 and aproximal portion804 and alight cable connector806. In this embodiment, ahandle808 and anactuator810 are included on thedistal portion802 of thecatheter800. The handle has anopening812 with adistal end814 and aproximal end816. When theactuator810 is seated against theproximal end816 of theopening812, the irrigation tubing (not shown, seeFIG.3) of themaxillary lavage catheter800 is contained within the maxillary lavage catheter. When theactuator810 is advanced in a one-handed fashion, with a single finger or thumb, and seated against thedistal end814 of theopening800, the irrigation tubing (not shown, seeFIG.4) is extended out of thedistal end818 of themaxillary lavage catheter800.
• As shown inFIG.1, theproximal portion106 of themaxillary lavage catheter100 includes aproximal irrigation tube120 with aproximal end124 and adistal end122. Theproximal end124 of theproximal irrigation tube120 contains aluer connector126 and the distal end connects to theproximal end112 of theelongate shaft108. Theluer connector126 connects theproximal end124 of theproximal irrigation tube120 with a source of irrigation for lavage of the maxillary sinus. A syringe (e.g., having a volume of about 10 cc to about 60 cc, for example) may be connected toluer connector126. The syringe may be used to drive the irrigation fluid out of theatraumatic tip118 by hand pressure by the operator on a hand pushable plunger of the syringe. Fluid pressures of about 4 to about 6 pounds per square inch (psi) are typically generated when using a 60 cc syringe, and pressures of about 15 to about 25 psi can be generated using a 10 cc syringe with flow rates of between about 50 ml/min and 250 ml/min, and often between about 75 ml/min and 125 ml/min. Alternatively, theluer connector126 may be connected to a vacuum source to apply suction to the maxillary sinus. Further, a pulsation device may be included to achieve pulsatile delivery of the irrigation fluid. An in-line valve assembly may be included between the fluid source, in this case a syringe, and the catheter, in this case theluer connector126. In a particular embodiment, to maximize irrigation efficiency, the valve assembly prevents flow when the applied force is low and allows fluid to pass one the pressure reaches a desired threshold.
• Further, apump device900 as shown inFIG.9 may be included to allow the user to continuously inject irrigation fluid without having to disconnect and refill the syringe. Thedevice900 may be constructed of asyringe902 with anintegrated spring904 that serves to force theplunger906 back in the direction ofarrow908 after the user has squeezed theplunger906 in the direction ofarrow910, toward thesyringe body912 and then released the pressure. Thedistal end914 of thesyringe902 is attached to aconnector916. Theconnector916 is also connected to a one-way exiting valve918 and a one-way entering valve920. Attached at the other side of the one-way exiting valve918 is tubing leading to the maxillary lavage catheter100 (shown inFIG.1). Attached to the other side of the one-way entering valve920 is afluid reservoir922, where the reservoir may be any type of fluid reservoir such as a fluid bath or a fluid bag. In this way, when the user pushers theplunger906 in the direction ofarrow910, the fluid is force through the exiting one-way valve918 to themaxillary lavage catheter100. When the force on theplunger906 is removed, thespring904 forces the plunger back, drawing irrigation fluid from thefluid reservoir922 through the entering one-way valve920 and into thesyringe body912. Filling of the syringe may also be accomplished by the user pulling back on theplunger906.
• Direct visualization markers and/or radiographic markers may be disposed along thelavage catheter100distal portion102. Generally, “direct visualization markers” refers to markers that may be viewed during use with the naked eye or by an endoscope. In one embodiment, flexibledistal portion102 may have a dark color, such as black, dark blue, dark grey or the like or may be transparent, and markers may have a light color, such as white, green, red or the like. In some embodiments, markers may have different colors and/or different widths to facilitate distinguishing the markers from one another during use. This contrast in colors may facilitate viewing the markers in a darkened operation room and/or when using an endoscope inside a patient in the presence of blood. Additionally one or more illumination fibers may be included in thelavage catheter100 to confirm access of the maxillary sinus.
• Lavage catheter100 is configured to irrigate into and suction fluids out of the maxillary sinus.Lavage catheter100 is sized appropriately to be delivered into adult as well as pediatric maxillary sinuses.Lavage catheter100 can also be used to deliver diagnostic or therapeutic substances into the sinuses or other areas in the paranasal space. Examples of such diagnostic or therapeutic substances include, but are not limited to: contrast agents, pharmaceutically acceptable salt or dosage form of an antimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic, antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., an NSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., an expectorant or mucolytic), an anesthetic agent with or without vasoconstrictor (e.g., Xylocaine with or without epinephrine, Tetracaine with or without epinephrine), an analgesic agent, an agent (anti-allergenic agent) that prevents of modifies an allergic response (e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen or another substance that causes secretion of mucous by tissues, anti-proliferative agents, hemostatic agents to stop bleeding, cytotoxic agents e.g. alcohol, and biological agents such as protein molecules, stem cells, genes or gene therapy preparations.
• In the method of the invention, the distal end of thelavage catheter100 is inserted deep into the maxillary sinus. Theactuator142 is slid from a first position adjacent theproximal hub132 to a second position adjacent thedistal hub136, there by advancing theatraumatic tip118 of thedistal irrigation tube114 well into the maxillary sinus. Irrigation is performed as irrigation fluid is pushed through theopening212 in theatraumatic tip118 using a syringe or other fluid introduction device attached to theluer connector126. Once lavage is complete, theactuator142 is retracted back to its first position adjacent theproximal hub132 and thelavage catheter100 is removed from the patient's anatomy.
• FIG.3 is a side view of amaxillary lavage catheter300 according to a further embodiment of the present invention. Similar to thelavage catheter100 shown inFIGS.1 and2, theirrigation tube314 coaxially surrounds the elongate shaft308 (seeFIG.4). Once thedistal end310 of thecatheter300 is positioned behind the uncinate near the maxillary sinus, thedistal end316 of theirrigation tube314 is advanced by slidingactuator342 on handle344 in the distal direction, thereby advancingirrigation tube314 into the sinus where irrigation occurs.FIG.3 shows theirrigation tube314 prior to advancement, andFIG.4 shows theirrigation tube314 following advancement into the sinus. Theirrigation tube314 is sufficiently flexible to navigate through the infundibular space, enter the sinus atraumatically, and provide adequate irrigation when flushed with sterile water, saline, or other liquid from a standard syringe or fluid injection device. Irrigation takes place through theelongate shaft308 and through irrigation holes at thedistal end316 of theirrigation tube314. The narrow tip envelope and curve allow for easy access and positioning behind the uncinate. Anatraumatic tip318 prevents damage to surrounding tissue while locating the ostium. The small distal end316 (approximately 1.5 mm to 2.5 mm in diameter) makes it easier to position thedistal end316 of theirrigation tube314 behind the uncinate. This provides theirrigation tube314 direction once it is actuated. The side irrigation holes of thedistal end316 and front blockage at theatraumatic tip318 allow for spray in all directions to effectively clean the sinus. Theatraumatic ball tip318 minimizes the risk of tissue damage while accessing the sinus.
• FIG.5 is a side view of a maxillary lavage catheter500 according to a further embodiment of the present invention. In this embodiment, theirrigation tube514 is coaxially surrounded by the elongate shaft508 (seeFIG.6). Once thedistal end510 of the catheter500 is positioned behind the uncinate near the maxillary sinus, thedistal end516 of theirrigation tube514 is advanced by slidingactuator542 in the distal direction, thereby advancingirrigation tube514 into the sinus where irrigation occurs.FIG.5 shows theirrigation tube514 prior to advancement, andFIG.6 shows theirrigation tube514 following advancement into the sinus. Theirrigation tube514 is sufficiently flexible to navigate through the infundibular space, enter the sinus atraumatically, and provide adequate irrigation. Irrigation takes place through theelongate shaft508 and through irrigation holes at thedistal end516 of theirrigation tube514. The narrow tip envelope and curve allow for easy access and positioning behind the uncinate. Anatraumatic tip518 prevents damage to surrounding tissue while locating the ostium. The small distal end516 (approximately 1.3 mm to 2.3 mm in diameter) makes it easier to position thedistal end516 ofirrigation tube514 behind the uncinate. This provides theirrigation tube514 direction once it is actuated. The side irrigation holes and front blockage on theatraumatic tip518 allow for spray in all directions to effectively clean the sinus. Theatraumatic ball tip518 minimizes the risk of tissue damage while accessing the sinus.
• Delivery of thelavage catheter100 of the current invention may be additionally or alternatively visualized by using an endoscope or by using fluoroscopy, electromagnetic or optical guidance, including 3-dimensional visualization such as CT or MRI visualization or other known visualization techniques. In one embodiment of the invention, one or more light fibers may be included in the lumen of thedistal irrigation tube114 such that advancement of theatraumatic tip118 into the maxillary sinus can be observed as a result of the transillumination of the maxillary sinus. Alternatively, thedistal irrigation tube114 may comprise a dual lumen tube, one lumen for irrigation and one for containing the light fibers for transillumination of the maxillary sinus. In the embodiment of the invention shown inFIG.7 a light fiber (or light fibers) can be integrated into thecatheter700 at thedistal tip end702 and theactuator704 of thehandle706. Thecatheter700 may be advanced into the sinus and positioned therein under endoscopic visualization. Once thecatheter700 is advanced into the sinus, the endoscope may be removed so that it can be used as a light source. The light end of the endoscope is placed at light access point708 by placing it directly onto theactuator704 as shown inFIG.7. This configuration eliminates the need for an extra light source and requires no additional steps by the user. After confirmation, the endoscope can be placed back into the nasal cavity for further endoscopic visualization.
• In an alternative embodiment, an extra light source could be provided to connect to the one or more light fibers. Connection of the one or more light fibers to the light source can be accomplished with a rotatinglight cable connector1000 as shown inFIGS.10A and10B. Using thislight cable connector1000, the user can rotate themaxillary lavage catheter100 while it is attached to a light source without the weight of the light cable (not shown) inhibiting rotation.
• As shown inFIG.10B, theconnector1000 contains agrommet1002 that is attached to theproximal end1112 of thetubing1004. The light fiber1006 (which may actually be one or more light fibers) is contained within thelumen1008 of thetubing1004. Thegrommet1002 is designed to float freely inside theconnector1002, thereby allowing thetubing1004 to spin freely when it is rotated. Thegrommet1002 is larger than thedistal hole1010 of theconnector1000, such that thegrommet1002, and therefore thetubing1004 is prevented from being pulled from theconnector1000 longitudinally.
• The invention has been described with reference to certain examples or embodiments of the invention, but various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise specified or if to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process have been described or listed in a particular order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or process unworkable for its intended purpose. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

Claims (21)

1-22. (canceled)

23. A catheter comprising:

(a) a shaft assembly comprising:

(i) an elongate shaft including a distal end, the distal end of the elongate shaft having a bend angle configured to promote access to a passageway associated with drainage of a paranasal sinus, and

(ii) a flexible irrigation tube coaxially disposed within the elongate shaft, the flexible irrigation tube having an atraumatic distal tip configured to deliver at least one fluid to the paranasal sinus, the flexible irrigation tube being configured to translate relative to the elongate shaft from a retracted position to an extended position while the distal end of the elongate shaft is adjacent to the passageway; and

(b) a handle assembly extending proximally from the shaft assembly, the handle assembly comprising:

(i) a proximal end,

(ii) a distal end, and

(iii) an actuator disposed between the proximal and distal ends of the handle assembly, the actuator being configured to translate from a proximal position to a distal position to actuate translation of the flexible irrigation tube of the shaft assembly from the retracted position toward the extended position while the distal end of the elongate shaft is adjacent to the passageway associated with drainage of the paranasal sinus for advancing the atraumatic distal tip of the flexible irrigation tube through the passageway and into the paranasal sinus.

24. The catheter ofclaim 23, the bend angle being between about 90 degrees and about 140 degrees.

25. The catheter ofclaim 24, the bend angle being between about 100 degrees and about 130 degrees.

26. The catheter ofclaim 25, the bend angle being about 110 degrees.

27. The catheter ofclaim 23, the distal end being bendable such that the bend angle is variable.

28. The catheter ofclaim 23, the atraumatic distal tip being configured to suction the at least one fluid out of the paranasal sinus.

29. The catheter ofclaim 23, the atraumatic distal tip comprising one or more radially facing openings.

30. The catheter ofclaim 29, the one or more radially facing openings being configured to spray the irrigation fluid in a plurality of directions to clean the paranasal sinus.

31. The catheter ofclaim 23, the atraumatic distal tip comprising a distal tip opening.

32. The catheter ofclaim 23, the actuator being disposed entirely between the proximal and distal ends of the handle assembly.

33. The catheter ofclaim 23, the actuator being configured to be moved with a finger or thumb of a hand while the handle assembly remains grasped by the hand.

34. The catheter ofclaim 23, the actuator being configured to remain positioned between the proximal end of the handle assembly and the distal end of the handle assembly when the actuator is in the proximal position, the actuator being further configured to remain positioned between the proximal end of the handle assembly and the distal end of the handle assembly when the actuator is in the distal position.

35. The catheter ofclaim 23, the handle assembly including an exterior surface, the actuator being configured to slide along the exterior surface of the handle assembly from the proximal position to the distal position to actuate translation of the flexible irrigation tube of the shaft assembly from the retracted position toward the extended position.

36. A catheter comprising:

(a) a shaft assembly comprising:

(i) an elongate shaft configured to access a passageway associated with drainage of a paranasal sinus,

(ii) a flexible irrigation tube coaxially disposed within the elongate shaft, the flexible irrigation tube being configured to translate relative to the elongate shaft from a retracted position to an extended position while a distal end of the elongate shaft is adjacent to the passageway, and

(iii) an atraumatic distal tip configured to deliver at least one fluid to the paranasal sinus; and

(b) a handle assembly extending proximally from the elongate shaft assembly, the handle assembly comprising:

a body comprising:

(A) a proximal end, and

(B) a distal end, and

(ii) an actuator disposed between the proximal and distal ends of the body, the actuator being configured to translate from a proximal position to a distal position to actuate translation of the flexible irrigation tube of the shaft assembly from the retracted position toward the extended position while the distal end of the elongate shaft is adjacent to the passageway associated with drainage of the paranasal sinus for advancing the atraumatic distal tip of the shaft assembly through the passageway and into the paranasal sinus.

37. The catheter ofclaim 36, the elongate shaft being bendable.

38. The catheter ofclaim 36, the atraumatic distal tip comprising one or more radially facing openings.

39. The catheter ofclaim 36, the atraumatic distal tip comprising a distal tip opening.

40. A method for lavaging a paranasal sinus of a patient with a catheter having (i) a shaft assembly and (ii) a handle assembly extending proximally from the shaft assembly, the method comprising:

(a) positioning a distal end of an elongate shaft of the shaft assembly adjacent to a passageway associated with drainage of the paranasal sinus; and

(b) translating an actuator disposed between proximal and distal ends of the handle assembly from a proximal position to a distal position to actuate translation of a flexible irrigation tube of the shaft assembly relative to the elongate shaft from a retracted position toward an extended position while the distal end of the elongate shaft is adjacent to the passageway, thereby advancing an atraumatic distal tip of the flexible irrigation tube through the passageway and into the paranasal sinus.

41. The method ofclaim 40, further comprising at least one of:

(a) delivering at least one fluid to the paranasal sinus via the atraumatic distal tip of the flexible irrigation tube; or

(b) suctioning at least one fluid out of the paranasal sinus via the atraumatic distal tip of the flexible irrigation tube.

42. The method ofclaim 40, further comprising bending the elongate shaft from a first configuration to a second configuration prior to positioning the distal end adjacent to the passageway, the second configuration defining a bend angle selected to promote access to the passageway.

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