US20080167527A1 - Surgical systems and methods for biofilm removal, including a sheath for use therewith - Google Patents

Abstract

Systems, methods, and apparatuses for one or more of reducing, removing, or preventing growth of bacterial biofilms are provided, including an endoscopic procedure using a surgical instrument adapted to dispense a pressurized flow of irrigant through a nozzle to substantially remove a layer of bacterial biofilm.

Description

BACKGROUND
• Bacterial biofilms develop in variety of bodily cavities, including those of the ear, such as the middle ear, and of the nose, such as the frontal or maxillary sinuses, for example. Regardless, the bacteria that generate biofilms often (but not necessarily) are a result of inflammatory insult to tissues, including inflammation arising due to fungi, temperature and pressure changes, allergens, or other sources. The emergence of bacterial growth and associated symptoms is often a cyclical, escalating process with initiation of the inflammatory process facilitating increased bacterial production, which, in turn, causes more inflammation, and so forth. Once bacterial growth has been established, the bacteria will often aggregate, stop dividing, and begin forming protective bacterial biofilm layers, or “slime layers,” comprised of polysaccharide matrices.
• The protective bacterial biofilm interferes with the body's natural immune response as well as traditional methods of treatment, often times resulting in chronic, recurrent infections and associated symptoms. In particular, the bacteria emit exotoxins, which incite the body's immune system to respond with white cells. However, the bacterial biofilm interferes with the efficacy of the white cells' ability to attack the bacteria. The biofilm can also act as a barrier against topical administration of antibiotics and other medicaments. Biofilm-forming bacteria also present obstacles to traditional, antibiotic treatments that act to kill dividing bacteria. In particular, the bacteria in a biofilm-forming state may have already ceased cell division, rendering such antibiotics largely ineffective.
• For example, relative to chronic rhinosinusitis and other similar ailments, bacteria in the nose can be viewed as a continuum. Some bacterias (e.g., certain strains of pseudomonas and staph aureus) form robust biofilms. Others (e.g., h. flu) form relatively mild biofilms. The biofilms may or may not include or contain fungi. Each of these microbes has a somewhat different or complimentary inflammatory pathway and interacts with the host's immune system differently. For example, staph aureus produces a lipopolysaccharide matrix that acts as an antigen and causes a host response, as well as toxins (e.g., staph exotin A and B, toxicshock syndrome toxin 1 and 2) that can produce an antigenic and even hyperantigenic (hyperinflammatory) response. Other microbes can also produce inflammatory-inciting toxins.
• Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure used to treat sinusitis, an infection of the sinuses. FESS opens up sinus air cells and sinus ostia (openings) with an endoscope. The use of FESS as a sinus surgical method has now become widely accepted. For reference, the term “functional” is meant to distinguish this type of endoscopic surgery from non-endoscopic, more conventional sinus surgery procedures.
• The purpose of FESS is typically to restore normal drainage of the sinuses, which requires ventilation through the ostia. In particular, a muco-ciliary transport process maintains a constant flow of mucus out of the sinuses with the hair-like cilia of a ciliated epithelium layer acting to direct the flow of mucus toward the ostia. Where there is insufficient ventilation or mucous transportation, infection and inflammation can result, a condition known as sinusitis. Sinusitis often develops from an infection where the maxillary and frontal sinuses meet near the nose or, occasionally, from a dental infection. Regardless, sinusitis causes the cilia to work less efficiently and causes the mucous membranes of the sinuses to become engorged, resulting in obstruction of the ostia. The ensuing lack of ventilation and drainage produce conditions which are ripe for bacterial infection, including biofilm-forming bacteria. As described above, such bacterial biofilms often interfere with effective treatment of bacterial infections, such as chronic rhinosinusitis.
• With the foregoing background, it has been postulated that effective treatment of recurrent, chronic inflammatory diseases, such as sinusitis, including chronic rhinosinusitis, requires therapies addressing associated bacterial infections and bacterial biofilms.
SUMMARY
• Some embodiments address a system for removal of bacterial biofilm from a target site of a human patient. Some systems include an irrigation duct, a nozzle, an aspiration duct, an endoscope, and a removable endoscope sheath. The irrigation duct is in communication with a fluid source. The nozzle communicates with the irrigation duct, the nozzle positioned to dispense the fluid directly at a target site. The aspiration duct is in communication with a vacuum source, the aspiration duct terminating at a distal inlet for aspirating fluid dispensed from the nozzle. The endoscope has an elongated insertion tube defining a working end adapted to facilitate imaging the target site. The removable endoscope sheath provides a barrier over at least a portion of the insertion tube during imaging. In particular, at least one of the irrigation duct and the aspiration duct is associated with the endoscope sheath.
• Other embodiments relate to endoscope sheaths for use in removing bacterial biofilm from a target site of a human patient. Some sheaths include an elongated, flexible outer sleeve adapted to receive an insertion tube of an endoscope. The outer sleeve defines a distal end maintaining a viewing window. The sheath also includes an irrigation duct formed as an elongated tube having a distal end maintaining a nozzle. The nozzle is secured adjacent the viewing window and is oriented to direct a pressurized stream of fluid away from the viewing window and directly against a layer of bacterial biofilm to mechanically remove the bacterial biofilm without substantially damaging an underlying structure of the target site.
• Still other embodiments relate to methods of removing bacterial biofilm from a target site of a human patient. Some methods include providing a system for removal of bacterial biofilm from a target site. The system includes an endoscope having an insertion tube defining a working end, an irrigation duct connected to a nozzle, an aspiration duct having an inlet, and a removable endoscope sheath for covering the insertion tube. At least one of the irrigation duct and the aspiration duct is part of the removable endoscope sheath. Each of the working end of the endoscope, the inlet of the aspiration duct, and the nozzle, respectively, is disposed proximate the target site, the target site including a layer of bacterial bio film adhered to a surface. The target site is imaged with the working end of the endoscope. A flow of fluid is dispensed through the nozzle, via the irrigation duct, toward the target site to mechanically remove a substantial portion of the layer of bacterial biofilm from the surface. The removed bacterial biofilm and the dispensed fluid are collected with the inlet end of the aspiration duct. Unlike conventional treatment techniques, the method can interrupt the inflammatory process of a patient by eradicating the underlying biofilm and source of toxins and other antigens and harbor for fungi.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a simplified, side view of a system for removal of bacterial biofilm, according to some embodiments.
• FIG. 2 is a side view of an endoscope useful with the system ofFIG. 1.
• FIG. 3 is a perspective view of a handle portion of the system ofFIG. 1.
• FIG. 4 is a cross-sectional view of the handle ofFIG. 3.
• FIG. 5 is a front perspective view of a removable endoscope sheath portion of the system ofFIG. 1.
• FIG. 6 is a side view of the sheath ofFIG. 5, with a portion shown in broken lines.
• FIG. 7 enlarged, perspective view of a portion of the sheath ofFIG. 5 with a portion of the sheath shown in broken lines.
• FIG. 8 is an enlarged, top cross-sectional view of a distal portion of the sheath ofFIG. 5, with a portion of the sheath shown in broken lines to assist in understanding.
• FIG. 9 is a side, cross-sectional view of a surgical instrument portion of the system ofFIG. 1, upon final assembly.
• FIG. 10 illustrates use of the instrument ofFIG. 9 relative to a human anatomy otherwise shown in simplified form.
• FIG. 11 is a side, cross-sectional view of a duct assembly useful with the system ofFIG. 1 in some other embodiments.
• FIG. 12 illustrates the duct assembly ofFIG. 1 in a deployed state.
• FIG. 13 is a side, cross-sectional view of another duct assembly useful with the system ofFIG. 1 in other embodiments.
• FIG. 14 illustrates the duct assembly ofFIG. 13 in a deployed state.
DETAILED DESCRIPTION
• Aspects of embodiments described herein relate to systems, methods, and apparatuses for one or more of reducing, removing, or preventing growth of bacterial biofilms. In particular, surgical biofilm removal systems, methods, and apparatuses adapted for such use will be understood with reference to the text and accompanying drawings.
• FIG. 1 shows a surgicalbiofilm removal system20, according to some embodiments. Thesystem20 includes a biofilm removalsurgical instrument22, alight source24, alight connector26, afluid source28, a fluid connector30, avacuum source32, avacuum connector34, animaging device36, animaging connector38, and acontroller39. In general terms, thelight source24 provides light to theinstrument22 through thelight connector26; thefluid source28 provides fluid to theinstrument22 through the fluid connector30; and thevacuum source32 provides vacuum flow, or aspiratory flow, to theinstrument22 through thevacuum connector34. Thecontroller39 controls operation of thesystem20 and is shown as being associated generally with thefluid source28, although thecontroller39 is optionally a stand-alone device or physically associated with any of the other system components, including, for example, theinstrument22.
• In some embodiments, theinstrument22 includes anendoscope40, ahandle42, and aremovable endoscope sheath44. In general terms, theendoscope40 is secured relative to thehandle42, with thehandle42 being used, in part, to facilitate maneuvering of theendoscope40. Thesheath44 is secured over theendoscope40, and in some embodiments, thesheath44 is also secured to thehandle42. Thesheath44 provides a protective barrier for theendoscope40 and is adapted to facilitate delivery of pressurized fluid in substantially removing a layer of biofilm (not shown), as subsequently described.
• As shown inFIG. 2, theendoscope40 can include various optical components and is generally adapted to image internal bodily structures (FIG. 10). In some embodiments, theendoscope40 includes an eyepiece50, a focus ring52, ahousing54, acontrol assembly56, a connection post58, and aninsertion tube60 that defines a workingend62 of theendoscope40. In general terms, at least a portion of theinsertion tube60 is disposed inside a human body (not shown) with the workingend62 of theendoscope40 being disposed at a target site (FIG. 10) to be imaged. “Imaging,” “adapted to image,” and similar language should be understood to be inclusive of direct visualization through the optical components of theendoscope40 as well electronic visualization and/or data analysis via electronic imaging, for example using the imaging device36 (FIG. 1) or other electronics.
• In some embodiments, the eyepiece50 is connected to thehousing54 for direct visualization and/or electronic visualization as referenced above, with the focus ring52 being disposed about the eyepiece50 and usable to bring images, or image data, into focus. Thehousing54 maintains various optical components of theendoscope40 and includes a body portion66 and a neck portion68. The body portion66 is relatively bulbous in shape. In turn, the neck portion68 extends in a tapering manner from the body portion66 and distally forms anannular connector flange69 from within which theinsertion tube60 projects.
• With continued reference toFIG. 2, in some embodiments, thecontrol assembly56 and the connection post58 are maintained by the body portion66. In turn, theinsertion tube60 is maintained by the neck portion68 and projects from theconnector flange69 as referenced above. During operation, thecontrol assembly56 is adapted to control selective bending of theinsertion tube60. The connection post58 is adapted for connection to thelight connector26, which, in combination with other components of theendoscope40, provides light at the workingend62 of theendoscope40.
• In some embodiments, theinsertion tube60 includes optical components, such as a fiber-optic bundle (not shown), and is substantially elongate, defining a proximal portion70, which is connected to thehousing54, and adistal portion72, which, more specifically, defines the workingend62 of theendoscope40. The proximal portion70 is substantially rigid while thedistal portion72 is adapted to be selectively bendable as indicated generally by broken lines inFIG. 2. For example, thedistal portion72 is optionally formed of a flexible material, a series of links, vertebrae, or is otherwise suited to embody bendability. Theendoscope40 includes components for actuating thedistal portion72, including those known to one having ordinary skill in the art, where thecontrol assembly56 is operable by a user to actuate bending of thedistal portion72 to aim the workingend62 in a desired direction.
• For reference,FIG. 2 shows thedistal portion72 in several positions with the use of broken lines. Although, the direction of bending is shown as being within a plane of the drawing sheet, or within a “drawing plane,” it should be understood that thedistal portion72 additionally or alternatively is selectively bendable in a plane orthogonal to the drawing plane, or any number of planes for that matter. It should also be noted that, in other embodiments, both the proximal anddistal portions70,72 are substantially flexible, or alternatively, substantially rigid. In still other embodiments, the proximal portion70 is selectively bendable and/or substantially flexible, while thedistal portion72 is substantially rigid. From this, it is readily understood that a variety of endoscope configurations are contemplated in association with the instrument22 (FIG. 1).
• During operation of theendoscope40, light is optionally provided to the workingend62 to illuminate an internal bodily structure or other target site being imaged, with associated images, or image data, being transmitted back from the workingend62 through theinsertion tube60 to the eyepiece50 and/or associated electronic devices, such as theimaging device36.
• Returning toFIG. 1, thehandle42 can similarly assume a variety of forms. One example configuration of thehandle42 is shown in greater detail inFIGS. 3 and 4, and includes or defines an interior80 and optionally includes agrip portion82, asupport portion84, atrigger assembly86, first tubing88, and asecond tubing89. As a point of reference, thetubings88,89 are removed from the view ofFIG. 3 to better illustrate other features of thehandle42.
• In some embodiments, thegrip portion82 extends from abutt end90 and can be characterized as being structured according to a pistol-grip configuration. In terms of use, thegrip portion82 is ergonomically designed to assist a user (not shown) with grasping and manipulating the instrument22 (FIG. 1) during use. Alternatively, thegrip portion82 can assume a variety of other shapes and/or sizes, and defines at least a portion of the interior80 along which thetrigger assembly86 and the first andsecond tubings88,89 are maintained, as described below.
• With specific reference toFIG. 3, thesupport portion84 is connected to thegrip portion82, and in some embodiments is integrally formed with thegrip portion82, for example via injection molding. Regardless, thesupport portion84 forms ascope cradle96 adapted to releasably retain the endoscope40 (FIG. 2), and a sheath interface98 adapted to releasably retain the sheath44 (FIG. 1).
• Thescope cradle96 includes or defines aproximal bracket100, ahousing carriage102, and adistal bracket104. Theproximal bracket100 is substantially U-shaped and is configured to form a complementary fit with the endoscope40 (FIG. 2), for example a frictional fit with the eyepiece50 (FIG. 2). Theproximal bracket100 is optionally adapted to flex apart to some extent in order to facilitate a releasable, friction fit with the eyepiece50. If desired, theproximal bracket100 additionally or alternatively includes a variety of means for releasably securing the eyepiece50 in theproximal bracket100, including, for example, detents, magnets, clips, adhesives, retaining pins, and others.
• In turn, thedistal bracket104 is substantially U-shaped according to some embodiments and includesdetents107,108, where thedistal bracket104 is configured to form a complementary fit with the neck portion68 of the endoscope40 (FIG. 2). In this regard, thedistal bracket104 can be adapted to flex apart to some extent in order to facilitate a releasable, friction fit with the neck portion68. In particular, thedetents107,108 are used in some embodiments to assist in frictionally and releasably securing the neck portion68 in thedistal bracket104. If desired, thedistal bracket104 additionally or alternatively includes a variety of means for releasably securing the neck portion68 in thedistal bracket104, including, for example, additional detents, magnets, clips, adhesives, retaining pins, and others.
• Thehousing carriage102 is sized and shaped to receive and support the endoscope40 (FIG. 2) as maintained in the proximal anddistal brackets100,104. If desired, thehousing carriage102 also includes means for releasably securing theendoscope40, such as those mentioned in association with the proximal anddistal brackets100,104. In some embodiments, thehousing carriage102 defines aconcave surface106 adapted to receive the body portion66 of theendoscope40 such that there is room for thecontrol assembly56, and asloped surface109 for receiving and/or supporting part of the neck portion68.
• With reference betweenFIGS. 3 and 4, the sheath interface98 of thegrip portion82 forms afirst receptacle110 and a second receptacle112 for sealingly receiving complementary features of the sheath44 (FIG. 1), as will be further elucidated in the ensuing discussion. Additionally, the first andsecond receptacles110,112 optionally form first and second fittings114,116 (FIG. 4), respectively, within the interior80 (FIG. 4) of thehandle42.
• In some embodiments, thetrigger assembly86 includes atrigger member120, a trigger sensor122, such as a switch, and aconnector124. Thetrigger member120 extends external to thegrip portion82 and is adapted to be actuated by a user (not shown), for example via a sliding interface relative to thegrip portion82. As best shown inFIG. 4, thetrigger member120 can be slidably retained within a collet125 that further retains a biasing device126 (e.g., a spring) that serves to bias thetrigger member120 to the extended position (relative to the grip portion82) reflected inFIGS. 3 and 4. Activation of thetrigger member120 thus entails a pushing force being applied thereon, sufficient to overcome a force of the biasing device126 to thus slide thetrigger member120 inwardly relative to the collet125. Other actuation arrangements of thetrigger member120 are also acceptable.
• The trigger sensor122 is adapted to provide an output indicative of actuation (e.g., sliding movement) of thetrigger member120, and thus can assume a variety of forms appropriate for sensing movement of thetrigger member120. Theconnector124, in turn, is adapted to carry, or transmit, the output from the trigger sensor122. Thus, theconnector124 can assume a variety of forms (e.g., tubing, wire, etc.), and is connected to the controller39 (FIG. 1). For example, theconnector124 is connected to the trigger sensor122 and protrudes externally to thehandle42 through thebutt end90 of thegrip portion82.
• With specific reference toFIG. 4, the first tubing88 of thehandle42 is connected to thefirst receptacle110 via the first fitting114. The first tubing88 extends through the interior80 of thehandle42 and out of thebutt end90 of thegrip portion82. Thesecond tubing89 of thehandle42 is connected to the second receptacle112 via the second fitting116. Thesecond tubing89 also extends through the interior80 of thehandle42 and out of thebutt end90 of thegrip portion82. As a point of reference, a portion of thesecond tubing89 is hidden from view behind the first tubing88 inFIG. 4.
• FIG. 5 shows thesheath44 of thesystem20 from a perspective view, according to some embodiments. For reference, thesheath44, or portions thereof, is optionally disposable. Alternatively, thesheath44 can be reusable and adapted for sterilization or otherwise adapted to be cleaned. In some embodiments, thesheath44 includes a manifold128, abarrier portion130, an aspiration duct132 (referenced generally), and an irrigation duct134 (referenced generally). In general terms, the manifold128 is adapted to be releasably connected to the endoscope40 (FIG. 2) and the handle42 (FIG. 3). In turn, thebarrier portion130 is adapted for insertion into a patient's anatomy.
• Thebarrier portion130 includes anouter sleeve135, and, in some embodiments, is assembled to define adistal segment136. Thedistal segment136 is described below as being bendable in association with some embodiments; it will be understood, however, that a remainder of thebarrier portion130 can be substantially flexible, rigid, malleable, or combinations thereof as desired. Alternatively, thedistal segment136 can be substantially rigid and not bendable.
• With additional reference toFIG. 6 (that otherwise illustrates portions of theouter sleeve135 with broken lines), in some embodiments, the manifold128 includes or forms aprimary frame137, asleeve hub138 and aninsertion tube guide140. The manifold128 also defines an interior142 (FIG. 9) and forms ascope connector144 and ahandle interface146. Thescope connector144 is adapted to be releasably secured to the connector flange69 (FIG. 2) of the endoscope40 (FIG. 2).
• In some embodiments, thesleeve hub138 projects distally from theframe137 and is adapted to form a complementary fit with thebarrier portion130. Theinsertion tube guide140 is an annular, hollow body, projecting distally from thesleeve hub138. Theinsertion tube guide140 is adapted to slidably receive the insertion tube60 (FIG. 2) of the endoscope40 (FIG. 2) according to some embodiments.
• Thescope connector144 extends from theframe137 opposite thesleeve hub138, and includes a plurality of projections orfingers148. In addition, thescope connector144 can include afirst release member150 and a substantially similar second release member (hidden in the view ofFIG. 6) opposite thefirst release member150, in some embodiments. In particular, one or more of the plurality ofprojections148 are adapted to be deflected upon insertion within the connector flange69 (FIG. 2) of the endoscope40 (FIG. 2) to releasably mate therewith. Thefirst release member150 and the second release member are associated with one or more of the plurality ofprojections148 such that depression of the respective release member(s)150 causes one or more of the plurality ofprojections148 to deflect inwardly to release thescope connector144 from theconnector flange69. In this manner, thescope connector144 acts according to what can be described as a “spring clip and release” or a “quick connect and release” mechanism in combination with thehandle interface146.
• In some embodiments, thehandle interface146 forms afirst coupling head154 andsecond coupling head156, which are adapted to be insertable within, as well as form complementary fits with, the first andsecond receptacles110,112 (FIG. 4), respectively, of the handle42 (FIG. 4). Each of the first and second coupling heads154,156 optionally includes a plurality of other sealing means160, such as o-rings, for forming a vacuum-tight and/or a liquid-tight seal, for example, with the first andsecond receptacles110,112, respectively.
• In some embodiments, theouter sleeve135 includes a substantiallycylindrical sleeve body178 defining aproximal end174, adistal end176, and a central lumen or similaropen space180. Theouter sleeve135 also includes aviewing window182. For reference thedistal end176 is sealed to theviewing window182, as well as the aspiration andirrigation ducts132,134 such that thecentral lumen180 is closed off, or sealed, from environment at thedistal end176. However, it is contemplated that in other embodiments, thedistal end176 is not sealed or is open, providing a path into thecentral lumen180. As referenced above, inFIGS. 6-8, a border of thesleeve body178 is shown with broken lines to better allow understanding of features residing within thesleeve body178.
• Thesleeve body178 is optionally formed of a substantially flexible, and, in some embodiments, elastomeric material. Although the figures reflect thesleeve body178 as being substantially circular in transverse cross-section, it should be understood that, in some embodiments, thesleeve body178 optionally conforms to theaspiration duct132 and/orirrigation duct134 to a greater extent than shown. Additionally or alternatively, thesleeve body178 is substantially rigid or substantially malleable in other embodiments.
• In order to give a point of reference as to the variety of sheath configurations contemplated, it should be noted that in some embodiments, substantially all thesleeve body178 of theouter sleeve135 is flexible, or bendable; in other embodiments, thesleeve body178 is flexible proximate thedistal end176 and more rigid proximate theproximal end174, or vice versa; and in still other embodiments, substantially all of thesleeve body178 is substantially rigid.
• As best shown inFIG. 7, theviewing window182 includes ahousing184 and alens186 secured to thehousing184, where thehousing184 is hollow and adapted to receive the working end62 (FIG. 2) of the endoscope40 (FIG. 2) such that the workingend62 abuts or comes in close proximity to thelens186 upon final assembly. Theviewing window182 is secured within thecentral lumen180 at or adjacent thedistal end176 of thesleeve body178. For example, theviewing window182 is optionally adhesively secured at thedistal end176. For reference, and as alluded to above, thedistal end176 of thesleeve body178 is optionally sealed to thelens186 to help prevent environment at thedistal end176 from entering thecentral lumen180.
• With reference toFIGS. 6,8, and9, theaspiration duct132 is formed of, or defined by, a plurality of sections190, including a manifold section190A, a proximal sleeve section190B (largely obscured by theirrigation duct134 inFIG. 6), and a distal sleeve section190C. Theaspiration duct132 can be supported by a reinforcement assembly192 (FIG. 8), and defines a proximal end194 (FIG. 9), a distal inlet end196 (FIG. 8), a distal inlet197 (FIG. 8), and a lumen198 (FIG. 8) for conveying an aspiratory flow between the proximal anddistal ends194,196. For reference, the plurality of tubular sections190 is formed as a single, continuous component; as separate, connected components; or combinations thereof, according to various embodiments. Theaspiration duct132, is optionally substantially flexible, substantially rigid, substantially malleable, or combinations thereof.
• As best shown inFIG. 9 (that otherwise illustrates theinstrument22 upon final assembly), the manifold section190A is optionally substantially rigid and/or formed as a part of the manifold128, for example being injection molded as a single piece with themanifold128. In other embodiments, the manifold section190A is formed of a separate, substantially elongate, flexible, tube (or “cannula”). Regardless, the manifold section190A of theaspiration duct132 is in fluid communication with thefirst coupling head154 of the manifold128 and defines a portion of the lumen198 (FIG. 8) of theaspiration duct132.
• With specific reference toFIGS. 6 and 8, in some embodiments, the proximal sleeve section190B (largely hidden) of theaspiration duct132 is substantially rigid and/or is formed continuously with the manifold section190A (FIG. 9), for example being injection molded as a single piece with the manifold section190A. In other embodiments, the proximal sleeve section190B is formed of a separate, substantially elongate, flexible, tube (or “cannula”), in fluid communication with the manifold section190A. Regardless, the proximal sleeve section190B extends distally from, and is in fluid communication with, the manifold section190A and defines a portion of thelumen198.
• As best shown inFIG. 8, in some embodiments, the distal sleeve section190C is substantially flexible and/or is formed as a separate, substantially elongate, tube (or “cannula”), in fluid communication with the proximal sleeve section190B. As will be described in greater detail below, flexibility of the distal sleeve section190C allows selective bending of the distal portion72 (FIG. 2) of the endoscope40 (FIG. 2) according to some embodiments. In other embodiments, the distal sleeve section190C is substantially rigid and/or is formed continuously with the proximal sleeve section190B as a single piece. Regardless, the distal sleeve section196C of theaspiration duct132 extends distally from, and is in fluid communication with, the proximal sleeve section190B and defines a portion of thelumen198.
• As mentioned above, theaspiration duct132, and in particular the distal sleeve section196C thereof, can be supported by thereinforcement assembly192. With this in mind, thereinforcement assembly192 can include areinforcement member200 and anend piece202. Thereinforcement assembly192 is maintained within the distal sleeve section190C, proximal thedistal inlet end196.
• Thereinforcement member200 is optionally a spring-like member which is bendable, yet resistant to being radially collapsed. Thus, thereinforcement member200 provides the distal sleeve section190C with some resistance to collapsing, while still being bendable, for example, where the distal sleeve section190C is otherwise formed of a substantially flexible member that might collapse under the negative pressure of an aspiratory flow. It should also be noted that in other embodiments, thereinforcement member200 is disposed around the distal sleeve section190C, or even as an integral component of the distal sleeve section190C.
• Theend piece202 is tubular and is optionally substantially rigid, assisting with reinforcement of the distal sleeve section190C according to some embodiments. For reference, theend piece202 and/or thedistal inlet end196 of theaspiration duct132 is optionally sealed to thedistal end176 of theouter sleeve135 to help prevent contamination of thecentral lumen180 of theouter sleeve135.
• Theirrigation duct134 is similar to theaspiration duct132, and includes (with combined reference toFIGS. 6,8, and9) a plurality of sections210, including a manifold section210A, aproximal sleeve section210B, and a distal sleeve section210C. Theirrigation duct134 is fluidly connected to anozzle212, and defines a proximal end214 (FIG. 9), adistal outlet end216, a distal outlet217 (FIG. 7), andcentral lumen218 for conveying a fluid (not shown) between the proximal anddistal ends214,216 and out thedistal outlet217. For reference, the plurality of sections210 is formed as a single, continuous component; as separate, connected components; or combinations thereof, according to various embodiments. Theirrigation duct134, is optionally substantially flexible, substantially rigid, substantially malleable, or combinations thereof. Although, it should be noted that the distal sleeve section210C is bendable in some embodiments to accommodate flexibility of the bendable section136 (FIG. 5) of the barrier portion130 (FIG. 5).
• With reference toFIG. 9, the manifold section210A is optionally substantially rigid and/or formed as a part of the manifold128, for example being injection molded as a single piece with themanifold128. In other embodiments, the manifold section210A is formed of a separate, substantially elongate, flexible, hollow, tube, which can also be described as a “cannula.” Regardless, the manifold section210A of theirrigation duct134 is in fluid communication with thesecond coupling head156 of the manifold128 and defines a portion of the lumen218 (FIG. 8) of theirrigation duct134.
• With reference betweenFIGS. 6 and 9, in some embodiments, theproximal sleeve section210B is substantially rigid and/or is formed continuously with the manifold section210A, for example being injection molded as a single piece with the manifold section210A. In other embodiments, theproximal sleeve section210B is formed of a separate, substantially elongate, flexible, tube (or “cannula”), in fluid communication with the manifold section210A. Regardless, theproximal sleeve section210B of theirrigation duct134 extends distally from, and is in fluid communication with, the manifold section210A and defines a portion of the lumen218 (FIG. 8) of theirrigation duct134.
• In some embodiments, the distal sleeve section210C is substantially flexible and/or is formed as a separate, substantially elongate, tube (or “cannula”), in fluid communication with theproximal sleeve section210B. As will be described in greater detail below, flexibility of the distal sleeve section210C allows selective bending of thebendable section136 of theendoscope40 according to some embodiments. In other embodiments, the distal sleeve section210C is substantially rigid and/or is formed continuously with theproximal sleeve section210B as a single piece. Regardless, the distal sleeve section210C of theirrigation duct134 extends distally from, and is in fluid communication with, theproximal sleeve section210B and defines a portion of the lumen218 (FIG. 8) of theirrigation duct134.
• With reference toFIG. 8, thenozzle212 is a hollow, tube (or “cannula”) adapted to act as a flow restricter in some embodiments. Thenozzle212 defines thedistal outlet217 in some embodiments, causing fluid to be ejected from theirrigation duct134 according to a desired flow rate and/or flow pattern, such as, a jet, spray, stream, aerosol, or other flow pattern. Thenozzle212 is maintained within thecentral lumen218 at the distal sleeve section210C, at or adjacent the distal outlet end216 of theirrigation duct134. In some embodiments, thenozzle212 and/or the distal outlet end216 of theirrigation duct134 is sealed to thedistal end176 of theouter sleeve135 to help prevent environmental contamination of thecentral lumen180 of theouter sleeve135 while still allowing a flow of fluid through thenozzle212 and out of thedistal outlet217.
• With reference toFIG. 6, thesheath44 is assembled according to some embodiments by disposing the proximal anddistal sleeve sections190B,190C,210B,210C, of theaspiration duct132 and theirrigation duct134, respectively, within thecentral lumen180 of theouter sleeve135. In turn, theproximal end174 of theouter sleeve135 is secured, releasably or otherwise, over thesleeve hub138 of themanifold128. The distal ends196,216 of the aspiration andirrigation ducts132,134, respectively, are sealed to thedistal end176 of theouter sleeve135 in some embodiments to help close thelumen180 of theouter sleeve135 from environment at thedistal end176 thereof. However, it should be understood that the aspiration andirrigation ducts132,134 themselves, and in particular thecentral lumens198,218 (FIG. 8), respectively, at thedistal inlet end196 anddistal outlet end216 are exposed, or open, through thedistal end176 of theouter sleeve135 such that irrigant can pass out of theirrigation duct134 and inspiratory flow and associated, aspirated matter can pass into theaspiration duct132 proximate thedistal end176 of theouter sleeve135.
• With reference toFIG. 7, in some embodiments, the distal outlet end216 of theirrigation duct134 is secured relative to thedistal end176 of theouter sleeve135 such that the nozzle212 (referenced generally) points longitudinally in substantially the same direction as theviewing window182. In this manner, the working end62 (FIG. 2) endoscope40 (FIG. 2) can be used to observe an area or target that a flow of irrigant from thenozzle212 is striking when the irrigant is within a field of view of theendoscope40. In other embodiments, thenozzle212 and theviewing window182 are oriented to define an intersection point (i.e., where the longitudinal line-of-sight from theviewing window182 intersects the longitudinal line of flow from the nozzle212) distal to theviewing window182, to promote viewing of the flow of irrigant proximate the intersection point. Thedistal inlet end196 of theaspiration duct132 is also secured relative to theouter sleeve135 and/orirrigation duct134, according to some embodiments, such that thedistal inlet end196 points in a substantially similar direction as thenozzle212 and/orviewing window182, although other orientations are also contemplated.
• In view of the above, it should be understood that in some embodiments, at least one of the aspiration andirrigation ducts132,134 is associated with thesheath44. As used herein, “associated with the sheath” is indicative of at least one of theducts132,134, respectively, being included as a part of thesheath44, such as being disposed or formed within theouter sleeve135, on theouter sleeve135, or being secured relative to theouter sleeve135. Furthermore, it should be understood that in some embodiments, the distal sleeve sections190C,210C of the aspiration andirrigation ducts132,134, as well as at least a corresponding portion of theouter sleeve135, respectively, form thebendable section136 of thebarrier portion130 such that it is repeatably bendable in conjunction with selective bending of theendoscope40, as previously alluded to, and as subsequently described.
• Assembly of thesurgical instrument22 according to some embodiments is described below with reference toFIG. 9. Theendoscope40 is secured to thehandle42 by releasably receiving the eyepiece50 of theendoscope40 in the proximal bracket100 (FIG. 4) of thehandle42. The neck portion68, and in particular, theconnector flange69, of theendoscope40, in turn, is releasably received in the distal bracket104 (FIG. 4) of thehandle42. With theendoscope40 so-received, the body portion66 rests over theconcave surface106, while allowing room for actuation of thecontrol assembly56, with the neck portion68, in turn, resting over and/or against the slopedarea109 of thehousing carriage102.
• In some embodiments, theendoscope40 is assembled to thesheath44 as follows. Theinsertion tube60 of theendoscope40 is slid through thescope connector144 and theinsertion tube guide140 of the manifold128, and into thecentral lumen180 of theouter sleeve135, such that the working end62 (referenced generally) is received against the lens186 (FIG. 7). With the workingend62 so-received, the workingend62 is secured relative to thesheath44, and in particular relative to theirrigation duct134, theaspiration duct132, and the nozzle212 (FIG. 8).
• Theendoscope40 is releasably secured to thehandle42 by inserting thescope connector144 of thehandle42 into theconnector flange69 of theendoscope40 to releasably secure the two, as previously referenced. From the foregoing, it should be understood that features and methods for assembling theinstrument22 as provided above are not only releasable, but also quick and intuitive in nature according to some embodiments.
• Returning toFIG. 1, other components of thesystem20 can assume a variety of forms. For example, thelight source24 can be adapted to provide illumination to theendoscope40, is secured to the connection post58 of theendoscope40 via thelight connector26, and can be of a type known to those of skill in the art. As previously referenced, thelight source24 provides light to theinstrument22, for illuminating a target site (FIG. 10).
• Thefluid source28 includes apump250 connected to a reservoir252. In some embodiments, thepump250 is a peristaltic pump, such as those typically used in association with surgical and/or endoscopic procedures, thepump250 serving to pressurize a flow of fluid from the reservoir252 to theinstrument22 as described below. The reservoir252 includes one or more IV bags, for example, filled with an irrigant, including the irrigating fluids described in U.S. patent application Ser. No. 11/431,495, entitled, “Biofilm Extracellular Polysaccharide Solvating (EPS) System,” and filed on May 10, 2006, the contents of which are incorporated herein by reference. In some embodiments, the irrigant includes medicaments, including those adapted to interfere with bacterial biofilm re-growth, surfactants, gels, antimicrobials, steroids, growth hormones, chemicals for reducing biofilm adhesion force, and others.
• Thefluid source28 is fluidly connected to theinstrument22 via the fluid connector30, which is a tubing set, for example. In particular, the fluid connector30 is in fluid communication with (or is formed as part of) thesecond tubing89 of thehandle42. Thesecond tubing89, in turn, is in fluid communication with the irrigation duct134 (FIG. 9) of thesheath44 upon assembly of theinstrument22. This places theirrigation duct134 in fluid communication with thefluid source28. It should also be noted that, in some embodiments, the fluid connector30 can include an auxiliary inlet or port (not shown), for introducing medicaments into irrigant (not shown) flowing from thefluid source28 and toirrigation duct134, for example, medicaments such as those previously referenced.
• The vacuum source32 (referenced generally) is adapted to provide an aspiratory, or vacuum flow, to theinstrument22 via thevacuum connector34. Thevacuum source32 is optionally of a type commonly used in association with surgical and/or endoscopic procedures and can include acollection canister250 fluidly connecting a source of negative pressure (not shown) to thevacuum connector34. Thevacuum connector34 is placed into fluid communication with, or is formed as part of, the first tubing88 of thehandle42 and the source ofnegative pressure32. The first tubing88, in turn, is in fluid communication with the aspiration duct132 (FIG. 9) of thesheath44 upon assembly of theinstrument22. In this manner, theaspiration duct132 is in fluid communication with thevacuum source32 according to some embodiments, such that an aspiratory flow is “pulled” through theaspiration duct132 with thevacuum source32. Additionally, in some embodiments, thecanister250 serves as a disposal means, such as a disposal tank, for collecting debris and other matter aspirated using theinstrument22, including those generally used in surgical and/or endoscopic procedures.
• Theimaging device36 is optionally an image sensor, such as a video camera, display, and/or other imaging electronics, including those typically used in association with endoscopic procedures. Theimaging device36 is connected to theinstrument22 via theimaging connector38. In particular, theimaging connector38 is placed into optical communication with the eyepiece50 of theendoscope40. As is conventionally known, theimaging device36 and theendoscope40 are used for imaging before, during, and/or after a surgical procedure using theinstrument22.
• As previously referenced, thecontroller39 controls operation of thesystem20 and is designated as being physically associated with thefluid source28, although thecontroller39 is optionally a stand-alone device or physically associated with any of the other system components, including, for example, thehandle42 orsheath44 of theinstrument22. In some embodiments thecontroller39 includes a microchip, memory, and/or other appropriate control electronics.
• Thecontroller39 is placed in communication with theinstrument22 and thefluid source28. For example, thecontroller39 is electrically connected to theinstrument22 via theconnector124 of the trigger assembly86 (referenced generally). Thecontroller39 can also be placed in direct or indirect communication with thefluid source28 and/orvacuum source32 via wiring or alternate means as appropriate, for example using wireless transmitters and receivers. Regardless, in some embodiments, actuation of thetrigger assembly86 sends a signal to thecontroller39, which in turn activates thefluid source28 to provide a flow of irrigant to theinstrument22 as desired. In some embodiments, thecontroller39 can further control operation of thevacuum source32, either directly or indirectly. It should also be noted that thecontroller39 can be programmed to operate thesystem20 according to a variety of desired irrigation and/or aspiration profiles, including ramped actuation, time delays, varied flow patterns, and others.
• The surgicalbiofilm removal system20 can be employed to perform a variety of procedures at various anatomical locations of a patient. By way of but one example,FIG. 10 illustrates internalbodily structures300 of a patient, including sinus cavities such asmaxillary sinuses310A,310B and frontal sinuses312A,312B, which are accessed through nares314A,314B. It should be noted that external features of the patient, including the nares314A,314B, are shown in dotted lines. For some procedures with which thesystem20 is useful (e.g., a patient suffering from chronic rhinosinusitis), afirst target site316 can be designated in association with a surface of themaxillary sinus310A for description of a surgical methodology for substantially removing a layer of biofilm. It should be understood, however, that similar principles apply across embodiments, including a variety of target sites associated with a variety of internal bodily structures, such as sinus cavities (the maxillary, frontal, sphenoid, and others), cavities of the ear (the middle ear, and others), etc. With that in mind, in some embodiments, thefirst target site316 is ciliated epithelium of themaxillary sinus310A that has an associated layer of bacteria and associated biofilm (not shown). In other embodiments, thetarget site316 is an artificial structure (not shown), such as sinus packing or a stent covered with a layer of bacterial biofilm, for example.
• With combined reference toFIG. 1 andFIG. 10, and with the foregoing description of thesystem20 in mind, some methods of removing bacterial biofilm (not shown) from one or more target sites internal to a patient include the following: setting up thesystem20; inserting a distal portion of theinstrument22 into themaxillary sinus310A; aiming the distal portion of the instrument22 (in particular the nozzle212 (FIG. 8)) at thetarget site316; delivering a pressurized flow of irrigant (not shown) from the irrigation duct134 (FIG. 8) and thenozzle212 to thetarget site316 to remove a substantial amount of the bacterial biofilm; and aspirating the irrigant, removed biofilm, and/or bodily secretions (not shown) away from thetarget site316 through the distal inlet197 (FIG. 7) of the aspiration duct132 (FIG. 8).
• In some embodiments, a functional endoscopic sinus surgery (FESS) is also performed prior to, or concurrently with, insertion of theinstrument22. For example, theendoscope40, and more generally, theinstrument22, is optionally adapted for, and/or used in combination with other implements as desired for, gaining access to thetarget site316 as part of an FESS procedure.
• Setting up thesystem20 according to some embodiments includes releasably securing theendoscope40, thehandle42, and thesheath44 together as previously described, where friction fit, detent, and/or “spring clip and release” mechanisms according to some embodiments provide a releasable assembly, that is quick and intuitive in nature. Other system components, including thelight source24,fluid source28,vacuum source32,imaging device36, andcontroller39 are connected to theinstrument22 as appropriate. Additionally, a sterile barrier320 (illustrated schematically inFIG. 1), such as sheeting or others commonly used in surgical and/or endoscopic procedures, is set up around theinstrument22 and the patient in some embodiments to help maintain a sterile operating environment.
• As referenced above, although some embodiments of acting upon a target site to remove a layer of biofilm are described with reference to themaxillary sinus310A and thetarget site316, it should be understood that biofilm removal at with other target sites and/or other cavities, including sinus cavities or cavities of the middle ear (not shown), proceeds in a substantially similar manner. With this in mind, inserting the distal portion of theinstrument22 into themaxillary sinus310A includes a practitioner (not shown) grasping thehandle42 and inserting the working end62 (FIG. 2) of the endoscope40 (FIG. 2) (as positioned within thesheath44 as previously described) into the nares314A and toward themaxillary sinus310A. In some embodiments, theendoscope40 acquires images during insertion in order to assist a surgeon or other practitioner guiding theinstrument22.
• With additional reference toFIG. 2, thedistal portion72 of theendoscope insertion tube60 is then selectively bent using thecontrol assembly56 to aim the workingend62 of theendoscope40 in a desired direction and/or to facilitate insertion of theinstrument22 into themaxillary sinus310A. The distal,bendable section136 of thesheath44 is also bent in conjunction with the selective bending of thedistal portion72. In particular, thedistal end176 of theouter sleeve135, including the viewing window182 (FIG. 5), is moved with movement of the workingend62 of theendoscope40. Additionally, the distal ends196,216 (FIG. 8) of the aspiration andirrigation ducts132,134 (FIG. 8) respectively, as well as the nozzle212 (FIG. 8) are also aimed, or otherwise track along with the workingend62 of theendoscope40.
• In some embodiments, the user (not shown) determines that theinstrument22 is properly “aimed” or otherwise disposed as desired in themaxillary sinus310A relative to a target site for debriding. For example, the user optionally determines proper positioning using images acquired with theendoscope40 and displayed to the user with theimaging device36. In some embodiments, the user identifiestarget site316 by observing the presence/location of the layer of biofilm, for example by evaluating images displayed to the user with theimaging device36.
• The user (not shown) then prompts delivery of a pressurized flow of irrigant to thetarget site316 to effectuate removal or eradication of a substantial amount of the bacterial biofilm (not shown) from thetarget site316 by squeezing the trigger member120 (FIG. 3). In response to this actuation, a signal is sent to thecontroller39 that in turn prompts activation of thefluid source28 to provide a flow of irrigant through the irrigation duct134 (FIG. 8) and the nozzle212 (FIG. 8). It is contemplated that the flow of irrigant will be directed through thenozzle212 at a variety of flow rates according to various embodiments, including a flow rate from about 2 ml/s to about 12 ml/s. In some embodiments, thesystem20 is adapted to cause pulsed flow through thenozzle212, in others substantially continuous flow, and in still others, a flow pattern other than pulsed or substantially continuous flow.
• In some embodiments, the flow of irrigant dispensed from thenozzle212 directly impinges upon, or otherwise directly strikes, thetarget site316 to mechanically agitate and remove a substantial portion, or substantially all, of the biofilm (not shown). In other words, thenozzle212 is able to be pointed directly at thetarget site316 as previously described when sufficiently accessible with theinstrument22, such that a mechanical “scrubbing” action is accomplished. It should be noted that the pressure and/or flow rate of the irrigant is selected to promote mechanical removal of the biofilm without substantial damage to underlying tissue, such as a ciliated epithelium layer. For example, in some embodiments, a pressure of less than about 50 psi at thetarget site316 is selected, although other pressures are contemplated.
• In some embodiments, aspiration of bacterial biofilm, bacteria, mucous, secretions, dead tissue, or other unwanted matter is accomplished using the aspiration duct132 (FIG. 8), for example during and/or after dispensing the irrigant (not shown) against thetarget site316. Theinstrument22 is operated to selectively or continuously activate thevacuum source32 in response to the user pulling the trigger member120 (FIG. 3), for example concurrently with irrigation or with some time differential (for example, before or after irrigation). The unwanted matter is removed from proximate thetarget site316 and is optionally directed to thebiological collection canister250 associated with thevacuum source32.
• The systems and methods described above are highly useful in surgically treating various maladies associated with multiple different anatomical locations or target sites. For example, in addition to sinus and inner ear target sites, the systems and methods of the present disclosure can be used to treat target site(s) in patient's lungs (e.g., cystic fibrosis in the respiratory epithelium of the lungs), urological and/or gynecological (e.g., urinary tract infections), etc.
• In view of the above, a method for removing biofilm from a surface within an internal bodily cavity (or other target site) under endoscopic visualization is provided according to some embodiments. It should be noted that various functions of theinstrument22 are optionally provided according to alternative embodiments, such as those described below in association withFIGS. 11-14.
• FIG. 11 shows aduct assembly400 optionally forming a part of the system20 (FIG. 1) according to some other embodiments. In some embodiments, theduct assembly400 is not otherwise associated with the sheath44 (FIG. 5) and is usable as a separate, distinct component. With this in mind, theduct assembly400 includes an inner tube (or “inner cannula”)410 and an outer tube (or “outer cannula”)412.
• Theinner tube410 is elongate and hollow, and defines aproximal end420, adistal end422, and adistal portion424 proximate thedistal end422. Aconnector428, such as a luer connector, is assembled to at theproximal end420. In some embodiments, thedistal portion424 defines a natural bend and is substantially flexible, such that thedistal portion424 is bendable into a substantially straight or less bent configuration upon exertion of an outside force, but will recover the natural bend upon removal of the external force (it being understood that in the view ofFIG. 11, thedistal portion424 is deflected to, or held in, a straightened state).
• Theouter tube412 is elongate and hollow, and defines aproximal end430, adistal end432, and adistal portion434 proximate thedistal end432. In some embodiments, thedistal portion434 defines a bend and is substantially less flexible, or relatively rigid, in comparison to thedistal portion424 of theinner tube410.
• FIG. 12 shows theduct assembly400 ofFIG. 11 in a deployed state, versus a retracted state as shown inFIG. 11. In particular, theinner tube410 is coaxially and slidably received in theouter tube412 such that thedistal end422 of theinner tube410 can initially be housed within theouter tube412 in the retracted state and be slid out of thedistal end432 of theouter tube412 to define the deployed state. In some embodiments, the natural bend of thedistal portion424, in combination with the bend of thedistal portion434, causes thedistal end422 of theinner tube410 to travel through an arcuate path as thedistal end422 is deployed from theouter tube412. In operation, this allows thedistal end422 to be deployed to a target site in relatively tight areas, such as the sinus cavities. In particular, theduct assembly400 defines a relatively elongate and compact retracted state, but can be used to curve around into hard to reach areas in the deployed state.
• In terms of use, theduct assembly400 is optionally used to functionally and/or physically replace use of the aspiration duct132 (FIG. 8), wherein theduct assembly400 is connected to the vacuum source32 (FIG. 1) using theconnector428 to aspirate proximate thetarget site316, for example. It should also be noted that a reinforcement member, such as one similar to the reinforcement member192 (FIG. 8), is optionally used in association with theduct assembly400, for example proximate thedistal end422 of theinner tube410. Additionally, if desired, theduct assembly400 can similarly serve instead as an irrigation duct, with a nozzle similar to the nozzle212 (FIG. 8), for example, secured proximate thedistal end422 of theinner tube410. Thus, where theduct assembly400 is used, methods of biofilm removal include disposing an inlet end of an aspiration duct non-concurrently with disposing a nozzle of an irrigation duct proximate a target site, according to some embodiments where an irrigation duct and aspiration duct of thesystem20 are not physically associated with one another, for example where theduct assembly400 is used to replace (physically or functionally) features of the sheath44 (FIG. 1), according to some embodiments.
• FIG. 13 shows analternative duct assembly500 optionally forming a part of the system20 (FIG. 1). In some embodiments, theduct assembly500 is not otherwise associated with the sheath44 (FIG. 1) and is usable as a separate, distinct component. Theduct assembly500 includes an inner tube (or “inner cannula”)510 and an outer tube (or “outer cannula”)512.
• Theinner tube510 is elongate and hollow and defines aproximal end520, adistal end522, adistal portion524 proximate thedistal end522, aproximal portion526 more proximate theproximal end520 and anintermediate portion528 between the distal andproximal portions524,526. Aconnector530, such as a luer connector, is mounted to theinner tube510 at theproximal end520. In some embodiments, each of the distal andproximal portions524,526 are substantially inflexible, while theintermediate portion528 defines a natural bend and is substantially flexible, such that thedistal portion524 is collapsible toward theproximal portion526 into a more bent configuration upon exertion of an outside force, but will recover the natural bend upon removing the external force.
• The outer tube512 is elongate and hollow, and defines aproximal end530, adistal end532, and aretainer534 proximate thedistal end532. In some embodiments, theretainer534 is sized and shaped to receive thedistal portion524 of theinner tube510.
• FIG. 14 shows theduct assembly500 ofFIG. 13 in a deployed state versus a collapsed state as shown inFIG. 13. In particular, theduct assembly500 defines a collapsed state where theinner tube510 is coaxially and slidably received in the outer tube512 such that thedistal end522 of theinner tube510 is bent back toward theproximal portion526, with thedistal end522 received in theretainer534. Theinner tube510 is then slid distally in the outer tube512 to release thedistal end522 from theretainer534, such that theintermediate portion528 transitions back to the natural bend and theduct assembly500 defines the deployed state. In operation, inserting theduct assembly500 in the collapsed state allows theduct assembly500 to be deployed to a target site in relatively tight areas, such as the sinus cavities. In particular, theduct assembly500 defines a relatively compact collapsed state, but can be used to hook or curve around into hard to reach areas, such as sinus cavities, in the deployed state.
• In terms of use, theduct assembly500 is optionally used to functionally and/or physically replace use of the aspiration duct132 (FIG. 8), wherein theduct assembly500 is connected to the vacuum source32 (FIG. 1) using theconnector530 to aspirate proximate the target site316 (FIG. 10), for example. It should also be noted that a reinforcement member, such as one similar to the reinforcement member192 (FIG. 8), is optionally used in association with theduct assembly500, for example proximate thedistal end522 of theinner tube510. Additionally, if desired, theduct assembly500 can similarly serve instead as an irrigation duct, with a nozzle similar to the nozzle212 (FIG. 8), for example, secured proximate thedistal end522 of theinner tube510. Thus, where theduct assembly500 is used, methods of biofilm removal include disposing an inlet end of an aspiration duct non-concurrently with disposing a nozzle of an irrigation duct proximate a target site, where the irrigation duct and aspiration duct are not physically associated with one another. In other words, where theduct assembly500 is used for aspiration or irrigation and is separate from the sheath44 (FIG. 1), for example, theduct assembly500 is disposed at thetarget site316 at a different time than thesheath44, according to some embodiments.
• The systems and methods of the present disclosure provide a marked improvement over previous techniques and devices used to treat various ailments, such as chronic rhinosinusitis. By effectuating biofilm eradication using a focused, pressurized fluid, a more complete treatment is provided to the patient on a minimally invasive basis. Further, with sinus and other applications, drainage pathway(s) are restored, ventilation of the treatment site is provided (thus minimizing opportunities for biofilm re-growth), and other functional endoscopic sinus surgery treatments can be provided (e.g., topical application of medicaments, irrigation, etc.).
• Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present invention. For example, the duct assemblies described herein are optional components for the biofilm removal system, and thus can be eliminated, as can one or more of the other components apart from the surgical instrument.

Claims (20)

1. A system for removal of bacterial biofilm from a target site of a human patient, the system comprising:

an irrigation duct in communication with a fluid source;

a nozzle communicating with the irrigation duct, the nozzle positioned to dispense the fluid directly at a target site;

an aspiration duct in communication with a vacuum source, the aspiration duct terminating at a distal inlet for aspirating fluid dispensed from the nozzle;

an endoscope having an elongated insertion tube defining a working end adapted to facilitate imaging the target site; and

a removable endoscope sheath for providing a barrier over at least a portion of the insertion tube during imaging;

wherein at least one of the irrigation duct and the aspiration duct is associated with the endoscope sheath.

2. The system ofclaim 1, wherein the endoscope insertion tube defines a substantially rigid proximal portion and a selectively bendable distal portion, and further wherein the endoscope includes a control assembly for actuating bending of the distal portion to aim the working end in a desired direction.

3. The system ofclaim 2, wherein the nozzle is secured relative to the working end of the insertion tube such that the nozzle can be selectively aimed with selective bending of the insertion tube.

4. The system ofclaim 2, wherein the distal end of the aspiration duct is secured relative to the working end of the insertion tube such that the aspiration duct can be selectively aimed with selective bending of the insertion tube.

5. The system ofclaim 1, wherein the aspiration duct further includes a reinforcement member proximate the inlet to reinforce the distal end of the aspiration duct against collapsing.

6. The system ofclaim 1, wherein the aspiration duct is substantially flexible and further wherein the reinforcement member is a bendable spring.

7. The system ofclaim 1, wherein the irrigation duct is in communication with the pressurized fluid via a tubing set for conveying a flow of the pressurized fluid from a fluid source to the irrigation duct, the tubing set having an auxiliary inlet for introducing a medicament into the flow of pressurized fluid from the fluid source to the irrigation duct.

8. The system ofclaim 1, wherein the aspiration duct is formed by:

an outer tube defining a distal end and a bend proximal the distal end; and

a flexible inner tube slidably received within the outer tube, such that the inner tube extends curvilinearly from the distal end of the outer tube upon extension of the inner tube from the distal end of the outer tube.

9. The system ofclaim 1, wherein the aspiration duct is formed by:

an outer tube defining a distal end and a proximal end, the outer tube comprising a body defining an inner lumen and a retainer proximate the distal end; and

an inner tube defining a first portion and a second portion with a naturally-curved and flexible section between the first portion and the second portion,

wherein the inner tube naturally defines a deployed state characterized by a first distance between the first portion and the second portion and is elastically deflectable to a collapsed state characterized by a second, smaller relative distance between the first portion and the second portion;

wherein the first portion of the inner tube is slidably received in the inner lumen of the outer tube and the second portion is received in the retainer of the outer tube to maintain the inner tube in the collapsed state.

10. An endoscope sheath for use in removing bacterial biofilm from a target site of a human patient, the sheath comprising:

an elongated, flexible outer sleeve adapted to receive an insertion tube of an endoscope, the outer sleeve defining a distal end maintaining a viewing window; and

an irrigation duct formed as an elongated tube having a distal end maintaining a nozzle, the nozzle being secured adjacent the viewing window and oriented to direct a pressurized stream of fluid away from the viewing window and directly against a layer of bacterial bio film to mechanically remove the bacterial biofilm without substantially damaging an underlying structure of the target site.

11. A method of removing bacterial biofilm from a target site of a human patient, comprising:

providing a system for removal of bacterial biofilm from a target site, the system including an endoscope having an insertion tube defining a working end, an irrigation duct connected to a nozzle, an aspiration duct having an inlet, and a removable endoscope sheath for covering the insertion tube, wherein at least one of the irrigation duct and the aspiration duct is part of the removable endoscope sheath;

disposing the working end of the endoscope, the inlet of the aspiration duct, and the nozzle, respectively, proximate the target site, the target site including a layer of bacterial biofilm;

imaging the target site with the working end of the endoscope;

dispensing a flow of fluid through the nozzle, via the irrigation duct, toward the target site to mechanically remove a substantial portion of the layer of bacterial biofilm; and

collecting the removed bacterial biofilm and the dispensed fluid with the inlet end of the aspiration duct.

12. The method ofclaim 11, wherein the bacterial biofilm is characterized by an adhesion force, and further wherein the fluid is adapted to chemically reduce the adhesion force.

13. The method ofclaim 11, wherein substantially all the layer of bacterial biofilm is removed with the dispensed fluid.

14. The method ofclaim 11, further comprising applying a medicament to the target site through the irrigation duct, the medicament adapted to interfere with bacterial biofilm re-growth.

15. The method ofclaim 11, further comprising delivering a medicament to the target site through the irrigation duct, the medicament selected from the group consisting of a surfactant, a gel, an antimicrobial, a steroid, a growth hormone, and combinations thereof.

16. The method ofclaim 11, wherein the flow of fluid is directed through the nozzle at a flow rate from about 2 ml/s to about 12 ml/s.

17. The method ofclaim 11, wherein the target site is within a sinus cavity.

18. The method ofclaim 11, wherein the target site includes ciliated epithelium.

19. The method ofclaim 11, wherein the inlet end of the aspiration duct is non-concurrently disposed proximate the structure relative to disposing the nozzle of the irrigation duct proximate the structure.

20. The method ofclaim 11, wherein the method is performed in treating chronic rhino sinusitis.

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