ENDOSCOPE SHEATH DEFLECTION DEVICES

Info

Publication number: 20150087911
Type: Application
Filed: Sep 23, 2014
Publication Date: Mar 26, 2015
Inventors: Gregory S. Konstorum (Stamford, CT), Ming J. Cheng (W. Warwick, RI)
Application Number: 14/493,581

Abstract

An endoscope sheath comprising: a tube having: a proximal end having a proximal end region and a distal end; and a conduit that extends through a portion of the endoscope sheath so that the proximal end region of the endoscope sheath and the distal end of the endoscope sheath are in fluid communication when an endoscope is inserted inside the endoscope sheath; and wherein the endoscope sheath is configured to receive all or a portion of the endoscope; wherein the distal end of the endoscope sheath has a flow director configured to direct irrigation fluid across a lens on the distal end of the endoscope; and wherein the flow director is a flexible flap.

Description

Description

FIELD

The present teachings generally relate to an endoscope sheath that receives all or a portion of an endoscope and more specifically to a deflection device at a distal end of the endoscope sheath that directs irrigation fluid from the distal end in a predetermined manner.

BACKGROUND

Endoscopes are typically used for minimally invasive surgery or to provide access to an internal location of a patient so that a doctor is provided with visual access. Endoscopes, during use, may be inserted into a location that may include debris that may cover the end of the endoscope and especially cover an imaging device located at the end of the endoscope. For example, an endoscope being used for surgery may become covered by blood and the blood may impair the vision of a surgeon so that surgery becomes increasingly difficult. Attempts have been made to provide various devices to assist a surgeon in clearing the debris from the imaging device of the endoscope and restore vision. These devices may remove some of the debris from the imaging device of the endoscope, however, these devices may not remove all of the debris and/or may leave spots on the imaging device, which may result in continued impairment. These devices may have features that attempt to control the flow of fluid, suction, or both at the end of the endoscope in an attempt to clear debris from the endoscope. Further, many of the features at the end of the sheath are configured to align the sheath with the endoscope and these feature perform little if any directing of fluid across the end of the endoscope.

Examples of some endoscope cleaning devices may be found in U.S. Pat. Nos. 5,413,092; 5,575,756; 5,989,183; 6,110,103; 6,447,446; 7,811,228; and 8,079,952, all of which are incorporated by reference in their entirety herein for all purposes. It would be attractive to have an endoscope sheath having an alignment device (i.e., an arm) that aligns a tip of an endoscope sheath with endoscope tips of various viewing angles. It would be attractive to have an endoscope sheath that directs fluid and/or suction across a distal end of the endoscope so that debris and other imagine blocking substances are removed from the distal tip of the endoscope. It would be attractive to have an endoscope sheath that angles fluid and/or suction across the imaging sensor of the endoscope so that the imaging sensor is cleared of debris, fluid spots, droplets, and interference. What is needed is an endoscope sheath that is configured to receive fluid, suction, one or more functional devices, or a combination thereof so that the fluid, suction, one or more functional devices, or a combination thereof are extended across a distal end of the endoscope.

SUMMARY

The present teachings meet one or more of the present needs by providing: an endoscope sheath comprising: a tube having: a proximal end having a proximal end region and a distal end; and a conduit that extends through a portion of the endoscope sheath so that the proximal end region of the endoscope sheath and the distal end of the endoscope sheath are in fluid communication when an endoscope is inserted inside the endoscope sheath; and wherein the endoscope sheath is configured to receive all or a portion of the endoscope; wherein the distal end of the endoscope sheath has a flow director configured to direct irrigation fluid across a lens on the distal end of the endoscope; and wherein the flow director is a flexible flap.

Another possible embodiment of the present teachings comprises: an endoscope sheath comprising: a proximal end having a proximal end region and a distal end; a conduit creating fluid communication between the proximal end region of the endoscope sheath and the distal end of the endoscope sheath when an endoscope is inserted inside the endoscope sheath; and a flow director at the distal end of the endoscope sheath; and wherein the distal end of the endoscope sheath has a first hole sized to fit around a distal end of the endoscope and at least partially align with a viewing lens, a visual port, or both of the endoscope so that the endoscope can view features of interest through the first hole, and wherein the flow director is configured as a flange including one or more second holes that are configured to direct irrigation flow distally from the endoscope and into a surgical site.

Yet another possible embodiment of the present teachings provides: an endoscope sheath comprising: a proximal end and a distal end; a flow director connected to the distal end of the endoscope sheath, the flow director including: one or more connection arms that form a fixed connection with an endoscope, a endoscope sheath, or both; a channel extending through the flow director that directs flow of an irrigation fluid across a distal end of the endoscope; and wherein flow of the irrigation fluid is changed from a first direction to a second direction by the flow director.

The teachings herein provide an endoscope sheath having an arm that aligns a tip of an endoscope sheath with endoscope tips of various angles. The teachings provide an endoscope sheath that directs fluid and/or suction across a distal end of the endoscope so that debris and other imagine blocking substances are removed from the distal tip of the endoscope. The teachings provide an endoscope sheath angles fluid and/or suction across the imaging sensor of the endoscope so that the imaging sensor is free of debris, fluid spots, and interference. The teachings herein provide an endoscope sheath that is configured to receive fluid, suction, one or more functional devices, or a combination thereof so that the fluid, suction, one or more functional devices, or a combination thereof are extended across a distal end of the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a top view of an endoscope sheath;

FIG. 1B illustrates a proximal end view of an endoscope sheath of FIG. 1A;

FIG. 1C illustrates a distal end view of an endoscope sheath of FIG. 1A;

FIG. 2 illustrates a cross sectional view of FIG. 1C along lines A-A;

FIG. 3A illustrates a side view of an endoscope inserted in the endoscope sheath of FIG. 1A;

FIG. 3B illustrates a distal end view of FIG. 3A;

FIG. 3C illustrates a close-up view of the distal end of the endoscope and sheath of FIG. 3A;

FIG. 3D illustrates a close-up side view of the distal end of the endoscope and sheath of FIG. 3A;

FIG. 3E illustrates a cross sectional view of FIG. 3B cut along line 3E-3E;

FIG. 3F illustrates a perspective view of a distal end of FIG. 3E;

FIG. 3G illustrates a perspective view of a distal end of a tube of a sheath;

FIG. 3H illustrates a bottom perspective view of a flow director;

FIG. 4 illustrates a side view of a tube of a sheath that includes a second opening;

FIG. 5A illustrates a side view of a tube of a sheath that includes a second opening extending parallel to the axis of the tube;

FIG. 5B illustrates a distal end view of the tube of FIG. 5A;

FIG. 6A illustrates a side view of a tube of a sheath that includes a second opening extending at an angle relative to the axis of the tube;

FIG. 6B illustrates a distal end view of the tube of FIG. 6A;

FIG. 7A illustrates an end plug of a sheath;

FIG. 7B illustrates a cross-sectional view of the end plug of FIG. 7A;

FIG. 8A1 illustrates a cross-sectional view of a multi-lumen sheath;

FIG. 8A2 illustrates a close-up view of the distal end of the multi-lumen sheath of FIG. 8A1;

FIG. 8B illustrates a cross-sectional view of the multi-lumen sheath of FIG. 8A cut along lines 8B-8B;

FIG. 8C illustrates a distal end view of the multi-lumen sheath of FIG. 8A viewed along line 8C-8C;

FIG. 8D illustrates a perspective view of the distal end of the multi-lumen sheath of FIG. 8A1;

FIG. 9 illustrates an example of the endoscope cleaner system of the teachings herein; and

FIG. 10 illustrates another example of a system including the endoscope sheath of the teachings herein.

DETAILED DESCRIPTION

The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the teachings, its principles, and its practical application. Those skilled in the art may adapt and apply the teachings in its numerous forms, as may be best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present teachings as set forth are not intended as being exhaustive or limiting of the teachings. The scope of the teachings should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description.

The present application claims priority to U.S. Provisional Patent Application Ser. No. 61/882,652, filed on Sep. 26, 2013, the contents of which are incorporated by reference herein in their entirety for all reasons. The present teachings provide an endoscope sheath for use in a system. The system of the teachings herein includes an irrigation source and a suction source that are both connected to an endoscope sheath that is in communication with an endoscope. The system may include one or more control modules. The system may function to clean an endoscope. Preferably, the system functions to clean a distal tip of an endoscope. More preferably, the system functions to clean an imaging device of an endoscope. The system may include one or more functional components that may extend proximate to a distal end of an endoscope or beyond a distal end of an endoscope. The system may provide one or more conduits relative to the endoscope. The system may protect the endoscope. The system may include one or more sources of irrigation fluid for use with the system, and the one or more sources of irrigation fluid, suction, or both may be controlled by one or more control modules.

The one or more control modules may function to control the amount of fluid, suction or both applied to a predetermined area, an area of interest, the endoscope, or a combination thereof. The one or more control modules may be powered by electricity, battery powered, or both. The one or more control modules may include one or more pumps, one or more valves, one or more user interfaces, or a combination thereof. The one or more user interfaces may be one or more control knobs, one or more selectors, one or more indicators, one or more user controls, one or more devices for changing a parameter, or a combination thereof. The one or more control modules may include any of the pumps discussed herein and based upon feedback from the user interface may control the pump to perform the selected parameter. The control module may include a microprocessor, a computer, a control algorithm, or a combination thereof. The control module may control one more valves located within the system, connected to the control module, or both. The one or more control modules may perform a suction function, an irrigation function, or a combination of both upon a selection by the user as is indicated by the user interface. The control module may control the running speed, pumping duration, or both of the pump so that irrigation fluid is moved to the sheath. The irrigation fluid may function to clean an endoscope, clear debris from a location proximate to the endoscope, be bioabsorbable, or a combination thereof. The irrigation fluid may function to move solid particles, move opaque fluids, or both. The irrigation fluid may be applied with a pressure. The pressure of the irrigation fluid may be varied by changing the height of the irrigation source relative to the sheath so that the head of the irrigation fluid is increased or decreased. The pressure of the irrigation fluid may be sufficiently high so that the irrigation fluid may be redirected by a flow director. The irrigation fluid may be applied with a pressure of about 0.10 MPa or more, about 0.20 MPa or more, about 0.30 MPa or more, or even about 0.50 MPa or more. The irrigation fluid may be applied with a pressure of about 3 MPa or less, about 2 MPa or less, about 1 MPa or less, or even about 0.75 MPa or less. The irrigation fluid may be applied with a sufficient amount of pressure that the surface tension of the irrigation fluid wicks the irrigation fluid across the distal end, the imaging portion, or both of the endoscope (e.g., the pressure may be low enough that the irrigation fluid remains in contact with the endoscope, the sheath, or both). The irrigation fluid may be applied with a gravity feed, thus, the pressure of the irrigation fluid may be determined by the height of an irrigation source. For example, the irrigation source may be an IV bag and the height of the IV bag may determine the amount of pressure and/or force generated at the distal tip of the sheath, endoscope, or both. The irrigation fluid may be applied by a pump that pumps the fluid at a predetermined pressure. The irrigation fluid may be continuously applied, intermittently applied, or both during an application cycle. The pressure of the irrigation fluid may change when the irrigation fluid reaches the end of an endoscope sheath so that the fluid cleans the endoscope, creates turbulence at the end of the endoscope, or both. Preferably, the pressure is sufficiently low so that the flow across the endoscope is laminar. The pressure of the irrigation fluid may be varied based upon the size, length, or both of an irrigation line extending between an irrigation source and the sheath. The irrigation source may be a reservoir that fluid is drawn from by a fluid movement mechanism (e.g., a pump) and moved through the sheath to provide irrigation to a distal end of an endoscope, to clean an endoscope, or both.

The pump may function to circulate irrigation fluid, move irrigation fluid through one or more lines, move fluid through a sheath, or a combination thereof. The pump may function to create a negative pressure (e.g., suction or vacuum). The pump may move fluid with an impeller. The pump may be a lobe pump, a centrifugal pump, a positive displacement pump, a rotary positive displacement pump, a diaphragm pump, peristaltic pump, rope pump, a gear pump, a screw pump, a progressing cavity pump, a roots-type pump, a plunger pump, or a combination thereof. Preferably, the pump moves a constant amount of fluid upon being activated, a constant amount of fluid may be varied from application to application, or both. More preferably, the pump is a peristaltic pump.

The one or more irrigation lines may function to connect the sheath to an irrigation source. The irrigation lines may function to create a head so that pressure is created and the irrigation fluid is applied with a force. The irrigation line may be flexible, movable, or both. The irrigation line may be made of any material that is compatible with the irrigation fluid, a patient, use in a surgical procedure, or a combination thereof. The irrigation line may connect the sheath to an irrigation source, a suction source, or both (i.e., suction may be applied through the irrigation line).

The suction source may function to remove fluid, debris, opaque fluids, unwanted material, or a combination thereof from a point of interest, from a distal end of the sheath, a distal end of the endoscope, or a combination thereof. The suction source may function to perform a drying function, remove fluid spots, or both. The suction source may be a pump, reversal of a motor, a common suction source, a hospital suction source, or a combination thereof. The suction source may apply a sufficient amount of vacuum to remove a predetermined amount of fluid in a predetermined amount of time. For example, the suction source may apply suction so that 10 ml of fluid may be removed in 1 to 2 seconds. The suction source may apply a continuous suction, intermittent suction, or both.

The suction line may function to connect to the sheath so that suction may be pulled through the sheath. The suction line may function to connect the sheath to a suction source. The suction line may assist is moving fluids, removing fluids, removing debris, removing opaque fluids, removing particles, or a combination thereof. The suction line may be any line that may assist in creating a vacuum at a distal tip of the endoscope, the sheath, or both. The suction line and the irrigation line may be the same line. The suction line and the irrigation line may be connected to a common line. The suction line and the irrigation line may be connected by one or more fittings, one or more valves or both.

The one or more valves may function to allow only one functions (e.g., irrigation or suction) to work at a time. The one or more valves may function to block the irrigation line, the suction line, or both. The one or more valves may only allow suction or irrigation to be applied at a given time. The one or more valves may be or include a check valve, a back flow preventer, or both. The one or more valves may be located proximate to the sheath, proximate to the irrigation source, proximate to the suction source, or a location therebetween. Each of the lines may include a valve. If more than one valve is present the valves may be electrically connected, hydraulically connected, fluidly connected, or a combination thereof so that if one valve is opened another valve is closed. The two or more valves (e.g., a first valve and a second valve) may be electrically connected, electrically controlled, or both. The two or more valves may be operated in a sequence (e.g., one opened and then one closed), operated simultaneously, operated on a delay, or a combination thereof. For example, only one valve may be open at a time. In another example, one may close and after a time delay another may open. The one or more valves may be part of a common fitting, located proximate to a common fitting, or both.

The one or more common fittings may function to connect two or more lines into a common line. The one or more common fittings may function to connect a suction line and an irrigation line to a common port. The one or more common fittings may connect a single line to multiple devices so that multiple devices may be used simultaneously, in series, in parallel, or a combination thereof. For example, the common fitting may connect a suction line and an irrigation line to a common line that is connected to a sheath and, during operation, an irrigation fluid may be applied and then after a delay and/or immediately when the irrigation fluid ceases to be applied, suction may be applied to the suction line so that irrigation fluid, excess irrigation fluid, debris, particles, opaque fluids, or a combination thereof are removed from the distal end of the endoscope. The one or more common fittings may have two or more openings, three or more openings, four or more openings, or even five or more openings. Each opening may receive at least one line and fluidly connect the one or more lines together. More than one common fitting may be used to connect multiple lines together. For example, a first common fitting with three openings may be connected to second common fitting with three openings so that two tubes are connected to one opening of the first common fitting and one tube is connected to each of the other two openings. Preferably, the common fitting is generally “Y” shaped and two of the openings lead into a third opening that is connected to a common line and/or a delivery line.

The common line may function to deliver irrigation fluid, suction, or both to a sheath. The common line may function to provide a combination of multiple different fluids, devices, suction levels, fluid pressures, or a combination thereof. The common line may provide a single access point between the irrigation source, the suction source, or both and the sheath. The common line may have an increased cross-sectional area (e.g., diameter) relative to the cross-sectional area of the irrigation line, the suction line, or both. The common line may be the same size as one or both of the irrigation line, the suction line, or both. The common line may extend between the common fitting and a port of the sheath. The common line may be a delivery line.

The delivery line may function to deliver fluids to a sheath. The delivery line may function to deliver suction to the sheath. The delivery line and the common line are preferably the same line. The delivery line, common line, or both may be used during an application cycle.

The application cycle may be any cycle where an endoscope is cleaned. The application cycle may be a cycle where a combination of different items are applied, a combination of different sequences are performed, or both. The application cycle may be a cycle where an irrigation fluid and suction are applied in a sequence to clean an endoscope. The application cycle may be a combination of one or more applications of fluid, one or more applications of suction, or both. The application cycle may be an application of fluid and immediately thereafter an application of suction to remove excess fluid form a point of interest, the distal end of the endoscope, the distal end of the sheath, or a combination thereof. The application cycle may have no delay between an end of the application of an irrigation fluid and the beginning of the application of suction. For example, upon completion of the irrigation fluid being applied the suction may immediately begin. The application cycle may be varied by a user. The application cycle may include only an application of fluid (i.e., a flushing cycle, a washing manner) with no suction. The application cycle may be user activated for a predetermined amount of time. The application cycle may be activated based upon a duration a user activates a switch. For example, a user may pre-set the activation cycle so that one touch of the switch causes the irrigation fluid to run for 5 seconds. The user may pre-set the activation cycle so that no suction is used. The application cycle may concurrent application of fluid and suction. For example, suction may begin being applied before the irrigation fluid is turned off. The application cycle of the irrigation fluid, the suction, or both may be changed by a user changing a selector, actuating a control longer, changing an input, or a combination thereof. The application cycle may be sufficiently long so that an image sensor of an endoscope is clear and good images may be taken.

The endoscope may function to provide an image to a surgeon, a doctor, a nurse, any other person who desires visual access to a remote location, or a combination thereof. The endoscope may be used for non-invasive surgery. The endoscope may be used for orthoscopic surgery. The endoscope may be inserted in a cut in tissue. The endoscope may be used for insertion into an orifice including an ear, nose, throat, rectum, urethra, or a combination thereof. The endoscope may have a generally circular cross-section. The endoscope may have a tubular section that is generally cylindrical. The endoscope may have a tubular section extending to the distal end and a handpiece connected to the tube and extending to the proximal end. The endoscope may include one or more image sensors in a distal end region.

The endoscope may include two or more image sensors. The endoscope may include an image sensor at the most distal point of the endoscope. The endoscope may include an image sensor that is located on an angle. The angle of the image sensor, viewing face, or both may be about 0°, 20°, 30°, 45°, 60°, 70°, or a combination thereof. The image sensor may provide black and white images, color images, thermal images, or a combination thereof. Preferably, the image sensor, imaging device, or both are located substantially at the distal end. The angle of the image sensor, the viewing face, or both may dictate the angle, shape, viewing cone, or a combination thereof of the endoscope.

The viewing cone may be an area that of visibility of the endoscope. The viewing cone may be variable, adjustable, or both. The angle of the viewing cone may be movable. The angle of the viewing cone may be predetermined based upon the type of endoscope selected. The angle of the viewing cone may not be affected by the flow director, lumen, sheath, or a combination thereof. The viewing cone may extend outward from the distal end of the endoscope in a cone shape.

The distal end of the endoscope may function to be inserted into a patient so that a feature of interest may be viewed through minimally invasive means. The distal end of the endoscope may be the leading portion of the endoscope (i.e., the first portion hat enters a patient). The distal end may function to provide washing functions, suction functions, irrigating functions, or a combination thereof that direct the irrigation fluid and suction across the viewing face of the endoscope, the lens, or both. The distal end of the endoscope may be on an opposing end of the endoscope as a proximal end. The proximal end may function to be gripped by a user. The proximal end may function to provide controls to a user. The proximal end may provide an interface for connecting other functional components such as an imaging device (e.g., a camera). The proximal end may function to provide power, sensing, suction, fluid, control, a connection point to outside devices, or a combination thereof to the distal end of the endoscope. The proximal end may be retained out of the patient and the distal end may be inserted in the patent. A shoulder may be located between the distal end and the proximal end.

The shoulder may function to prevent the proximal end from entering a patient. The shoulder may function to form a connection point with a tube of the endoscope. The shoulder may be a terminal portion of a proximal end of the endoscope. The shoulder may prevent a sheath from axially moving towards the proximal end of the endoscope. The shoulder may be a distal end of the proximal end portion of the endoscope. The shoulder may be generally vertical, generally flat, generally orthogonal to the longitudinal axis of the tubular section of the sheath, or a combination thereof. One or more light posts may be located in a distal end region of the proximal portion of the endoscope and the light post may be located on a proximal portion of the endoscope relative to the shoulder (e.g., between the shoulder a visual port but closer to the shoulder end then a visual port end).

The light post may function to provide light into the endoscope. The light post may direct light into the endoscope and out of the tube of the endoscope so that a feature of interest is illuminated. The light post may provide light so that a user can see features of interests that are located in low light conditions. The light post may be rigid. The light post may be immobile and/or fixedly connected to the endoscope so that the light post has a fixed position on the endoscope. The light post may be made of metal, plastic, a biocompatible material, or a combination thereof. The light post may be integral with a main portion of the proximal end. The light post may be made of metal and some other biocompatible material. The one or more light posts may provide light through the endoscope, so that the visual port may be used for observing a feature of interest at a distal end of the endoscope.

The visual port may function to provide a viewing window for a user. The visual port may function to allow a user to observe a feature of interest. The visual port may function to provide an output so that an image is displayed on a monitor. The visual port may provide visual access through the endoscope to a user. The visual port may provide a connection point to a camera that displays the image on a larger image device such as a television or a monitor. The visual port may be an optical window at the proximal end that provides visual access to a viewing lens at the distal end.

The viewing lens may function to provide a window that an image sensor views through. The viewing lens may function to protect an image sensor (e.g., a camera). The viewing lens may be a cover over an image sensor. The viewing lens may be a viewing face of the endoscope and vice versa. The viewing face may be a surface of the endoscope that an image is generated through. The viewing lens may have a cross-sectional length (e.g., diameter) that is less than the cross-sectional length of the endoscope. The viewing lens may have a largest dimension that is larger than the cross-sectional thickness of the endoscope. For example, when the endoscope has an imaging device at a 70° angle the viewing lens may be greater than the cross-sectional length of the endoscope. The viewing lens may protect the imaging device (e.g., camera) from fluid, damage, corrosion, or a combination thereof. The viewing lens may cover one or more imaging devices or even two or more imaging devices. The viewing lens when in use may become covered with debris, fluid, blood, opaque fluids, or a combination thereof. The viewing lens may be inhibited from allowing a clear image to be formed. The viewing lens may be partially or fully covered by a sheath, be partially or fully surrounded by a sheath, or both. Preferably, the sheath is located proximate to the viewing lens without interfering with the range of vision created by the viewing lens.

The sheath may function to provide one or more conduits, lumen, or both for a fluid, suction, a functional device, or a combination thereof to extend out of a distal end region of the sheath. The sheath may function to form one or more lumen for fluid, suction, a functional device, or a combination thereof to extend out of a distal end region of the sheath. The sheath may be open at both ends. The sheath may be open at the distal end and the proximal end so that an endoscope may be inserted into the proximal end and extend through the sheath and view a feature of interested located near the distal end. The distal end of the sheath may have a stop that located the distal end of the endoscope relative to the distal end of the sheath. The sheath may function to provide cleaning, washing, or both of an endoscope. The sheath may provide a conduit, a lumen, or both that extends from a proximal end to a distal end. The sheath may include one or more lumen, create one or more lumen, or both. The sheath may include one or more parts that when connected together create a conduit that provides irrigation fluid, suction, or both to a distal end of the endoscope. The sheath may substantially mirror the shape of the endoscope. Thus, for example, if the endoscope has a circular cross-section then then sheath has a circular cross section. The sheath may function as an endoscope cleaner. The sheath may have a distal end and a proximal end with a longitudinal axis that extends therebetween.

The distal end of the sheath may function to direct irrigation fluid, suction, or both across the viewing lens, the distal end, or both of the endoscope. The distal end may function to open, be open, or both so that irrigation fluid may exit the sheath. The distal end may function to not interfere with the imaging capabilities of the endoscope. The distal end may open out so that pressure of the irrigation fluid drops as the irrigation fluid reaches the distal end. The distal end may be free of any integrally formed pieces that direct irrigation fluid, suction, or both across a distal end of the endoscope. The distal end may be free of any extensions that extend from the distal end. The distal end may be free of any pieces that extend from a portion of a distal most end of the sheath. The distal end may be substantially equal around a circumference of the sheath. The distal end region may include one or more annular gaps (e.g., a ring shaped gap). One or more slots may be located in a distal end region proximate to the distal end of the sheath.

The one or more slots may function to receive one or more flow directing devices. The one or more slots may function to connect one or more flow directing devices to a distal end of the sheath. The one or more slots may be a through hole. The one or more slots may function to retain one or more flow directing devices at a distal end of the sheath, the distal end of the endoscope, or both. The one or more slots may be located in a distal end region of the sheath, a tube of the sheath, or both. The one or more slots may have any shape that receives and maintains a flow directing device in a distal end region. The one or more slots may have a shape that is square, round, rectangular, diamond, rhombus, regular, irregular, symmetrical, asymmetrical, includes one or more inwardly projecting portions, one or more fingers, or a combination thereof. The one or more slots may have any shape that retains a flow directing device within an end region of the sheath. If more than one slot is present the slots may be located adjacent, in the same plane, in a line, be axially spaced apart, radially spaced apart, or a combination thereof. The one or more slots may each receive a flow directing device and the flow directing device may be any flow directing device discussed herein and preferably one or more flexible flaps.

The one or more flexible flaps may function to direct fluid across a distal end of an endoscope. The one or more flexible flaps may be a flow director. The one or more flexible flaps may function to clean, wash, or both a distal end of an endoscope. The one or more flexible flaps may function to direct an irrigation fluid from one edge of a sheath to a second edge of a sheath. The one or more flexible flaps may be opened by pressure of the irrigation fluid. The one or more flexible flaps may be opened by a pressure of about 0.05 MPa or more, about 0.1 MPa or more, about 0.2 MPa or more, or even about 0.3 MPa or more. The one or more flexible flaps may be elastically deformable. The one or more flexible flaps may be self-closing. The one or more flexible flaps may open during an application of irrigation fluid and close when the application of irrigation fluid is complete. The one or more flexible flaps may be made of a single material and a central portion of the flexible flap may move and permit fluid flow across the distal end. The one or more flexible flaps may be made of two or more materials and one material may be flexible or have a lower flexing point so that the material with the lower flexing point deforms during an application of irrigation fluid. The flexible flap may allow a variable amount of irrigation fluid to exit. The flexible flap may vary the direction of the irrigation fluid. For example, initially upon irrigation fluid being applied the flexible flap may direct fluid directly across the image sensor and as the flexible flap opens the fluid may extend further from the image sensor. The one or more flexible flaps may include an elastomer, an elastomeric material, rubber, metal, plastic, a thermoplastic, a thermoset, or a combination thereof. The one or more flexible flaps may cover one or more openings in the sheath, one or more lumen, one or more portions of the endoscope, or a combination thereof. The one or more flexible flaps may receive the endoscope regardless of the angle of the endoscope (e.g., 0°, 30°, 45°, 60°, 70° etc. . . . ). Each of the one or more flexible flaps may be configured to receive a specific endoscope with a specific angle. The one or more flexible flaps may extend across about 3 percent or more, 5 percent or more, or 10 percent or more of the sheath opening. The one or more flexible flaps may extend across about 50 percent or less, about 40 percent or less, or about 30 percent or less of the sheath opening (i.e., the opening that the endoscope gathers images through). The one or more flexible flaps may extend across an opening of the sheath without interfering with imaging by the endoscope. The one or more flexible flaps may extend across the opening of the sheath without contacting the endoscope. The one or more flexible flaps may contact a portion of the endoscope. The one or more flexible flaps may contact the endoscope without impairing imaging capabilities of the endoscope. The one or more flexible flaps may include one or more flap connectors.

The one or more flap connectors may function to connect the flexible flaps to a sheath. The one or more flap connectors may function to extend into a slot in a sheath. The one or more flap connectors may extend all of the way through a slot in a sheath. The one or more flap connectors may form a friction fit, an interlocking fit, a mechanical connection, a snap fit, or a combination thereof with a sheath and preferably a slot in the sheath. The flap connector may extend from a flap body.

The flap body may function to assist in connecting the flexible flap to the sheath. The flap body may extend between one or more flap directors and one or more flap connectors. The flap body may function to direct fluid toward the distal end of the endoscope, across a distal end of the endoscope. The one or more flap connectors may extend from a main portion, a central portion, or both of the flap body. The one or more flap connectors may extends from a side of the flap body, a distal end, a proximal end, or a combination thereof. The location of the flap connector relative to the flap body may vary based upon the angle of the endoscope that the flexible flap is to be used with. The flap body may extend along an inside of a sheath. The flap body may be flexible. The flap body may be rigid. The flap body may be more rigid than the flap director. The flap body may be thicker than the flap director so that the flap director is flexible and the flap body is inflexible. The flap body may assist in forming a lumen in the sheath, may direct fluid along an inside of a sheath, or both. The flap director may form a cantilever connection with one or more flap directors.

The flap directors may function to direct fluid across a distal end of the endoscope. The flap directors may function to move when irrigation fluid is being applied. The flap directors may change the direction of irrigation fluid, suction, or both throughout an application of irrigation fluid, suction or both. For example, when irrigation fluid is first applied the flexible flap may direct irrigation fluid directly across the endoscope and as the duration of application continues the angle the irrigation fluid is directed may increase and during the application of suction the reverse may occur. The flap directors may extend at an angle relative to the flap body. The flap directors may extend at an angle of about 75 degrees or more, about 90 degrees or more, about 105 degrees more, about 115 degrees more, about 125 degrees or more, or even about 135 degrees more relative to the flap body. The flap directors may extend an angle of about 180 degrees or less, about 165 degrees or less, about 150 degrees or less, or even about 140 degrees or less. When more than one flap director is present the flap directors may actuate individually. The flexible flap may include two or more flap directors, three or more flap directors, or even four or more flap directors. The one or more flap directors may be movable relative to each other. The one or more flap directors may be separated by one or more flap slots.

The one or more flap slots may separate one or more flap directors. The one or more flap slots may function to allow for individual movement of two or more flap directors. The one or more flap slots may extend substantially the same length as the flap directors. The one or more flap slots may extend to a distal end of the sheath. The one or more flap slots may be a cut in the flap directors so that two or more discrete flap directors are formed. The one or more flap slots may be square, rectangular, triangular, diamond shaped, symmetrical, asymmetrical, or a combination thereof. The size and shape of the one or more flap slots may determine the amount of force and/or pressure required to move the flap director. For example, a longer flap (e.g., 5 mm) slot may lower the strength of the flap directors relative to a shorter flap slot (e.g., 2 mm). The flap slot may be about 1 mm or more, about 2 mm or more, about 3 mm or more, about 4 mm or more, or even about 5 mm or more in length, width, or both. The flap lot may be about 20 mm or less, about 15 mm or less, or about 10 mm or less in length, width, or both. The one or more flap slots may allow the imaging device, the viewing cone, or both to view through the flexible flap. The one or more flap slots may be aligned with the opening in the sheath.

The opening in the sheath that the endoscope gathers images through may be a first opening in the sheath. The first opening in the sheath may be a primary opening. The first opening in the sheath may align with an end of the endoscope. The first opening may function to locate the distal end of the endoscope laterally, longitudinally, radially, or both with respect to the distal end of the sheath. The first opening may function to allow the endoscope to gather images without interference. The first opening may function to mirror the angle of the viewing lens, the imaging device, imaging sensor, viewing face, or a combination thereof. The first opening may extend at an angle relative to the longitudinal axis of the sheath. The first opening may extend perpendicular to the longitudinal axis of the sheath. The first opening may be located adjacent to a second opening.

The second opening may function to irrigate fluid located proximate to the distal end of the endoscope. The second opening may function to direct fluid away from the distal end of the endoscope. The second opening may be directed towards the first opening, away from the first opening, parallel to the first opening, at an angle relative to the first opening, or a combination thereof. The second opening may extend at an angle relative to the longitudinal axis. The second opening may extend at an angle of about 0° or more, 15° or more, 30° or more, 45° or more, 60° or more, 70° or more with the longitudinal axis, the first opening, or both. The second opening may direct fluid at an angle of about 0° or more, 15° or more, 30° or more, 45° or more, 60° or more, 70° or more with the longitudinal axis, the first opening, or both. The second opening may be a through hole. The second opening may be a second lumen that is created by an inner wall in the sheath. The first opening and the second opening may be a weep port and a lavage port. The second opening may be created by a flexible flap. The second opening be partially covered or fully covered by the flexible flap. The second opening may be absent when a flexible flap is used. The second opening may be located outside of the flexible flap, on an opposite side of the sheath as the flexible flap, or both. The second opening may be located in a thicker portion of the sheath wall. For example, the cross-sectional thickness of the sheath wall may not be uniform and the second opening may extend through a thicker portion of the sheath. The sheath may include one or more features around a circumference of the sheath that are configured to receive a through hole, form a through hole, form the second opening, or a combination thereof. The sheath may include a portion that folds back upon itself creating a pocket and the second opening may extend through a portion of the fold. The second opening may be integrally formed in the sheath. The second opening may be formed in the sheath after the sheath is formed. The second opening may be adjustable, static, fixed, or a combination thereof. The second opening may include an insert that is adjustable. The second opening may include an insert that has elastomeric capabilities and adjusts flow out of the second opening, provides a variable direction of flow out of the second opening, or both. The second opening may extend from a lip, opposite a lip, through a lip, or a combination thereof.

The sheath may include one or more lips. The one or more lips may be a flow director. The one or more lips may function to assist in directing irrigation fluid across the lens, imaging device, or both of the endoscope. The one or more lips may function to substantially mirror the shape of the endoscope. The one or more lips may overhang the endoscope. The one or more lips may provide a protective cover for the endoscope. The one or more lips may only be used when a flexible flap is used. The one or more lips may be located on a distal end opposite a proximal end of the sheath.

The proximal end of the sheath may function to create a connection with the endoscope. The proximal end may align the sheath relative to the endoscope. The proximal end of the sheath may axially align the sheath relative to the endoscope, radially align the sheath relative to the endoscope, axially align the distal ends of the sheath and the endoscope, the sheath axially relative to a light post of the endoscope, the sheath rotationally relative to a light post of the endoscope, or a combination thereof. The proximal end may receive all or a portion of the endoscope. The proximal end may contact a shoulder of the endoscope. A longitudinal axis may extend between the proximal end and the distal end of the sheath. The longitudinal axis may extend through a through hole, channel, lumen, or a combination thereof that extends the length of the sheath. The endoscope may extend within the sheath along the longitudinal axis. The longitudinal axis may extend from a connection point between the endoscope and the sheath and through a tube of the sheath.

The tube may function to receive the imaging device of the endoscope. The tube may be located at the distal end of the endoscope. The tube may be generally the same size and shape as the endoscope. For example, if the endoscope has a generally circular cross-section then the tube may have a generally circular cross-section. The tube may have a shape that is different than the endoscope. The tube may be any shape so that the tube is configured to receive the endoscope. The tube may be connected to: a hub, integrally formed with a hub, in fluid communication with a port, connected to a port, include a through hole that is in communication with a port, or a combination thereof. The tube may be connected to a handpiece at the proximal end. The tube may be integrally formed with a handpiece. The tube may have a uniform wall thickness, a variable wall thickness, or both. The wall thickness may vary along the length of the tube. The wall thickness may vary along the circumference of the tube. For example, the tube may have a wall that is twice as thick on a bottom half of the tube than a top half of a tube when viewing the tube in a cross-section. The tube may include the lip, slot, flexible flap, first opening, second opening, end plug, first lumen, second lumen, weep port, lavage port, flow director, or a combination thereof discussed herein. The tube may include one or more positioning devices along its length. The one or more positioning devices may be one or more dimples.

The one or more dimples may function to position an endoscope within a sheath, a tube of the sheath, or both. The one or more dimples may function to position the endoscope within the sheath. The one or more dimples may create a space, a conduit, a lumen, or a combination thereof between a wall of the sheath and the endoscope. The one or more dimples may be a portion of the wall of the sheath that extends inward. The one or more dimples may be generally round, square, oval, triangular, rounded, have a flat surface, have a rounded surface, be hemispherical, or a combination thereof. The one or more dimples may be located on opposing sides of the tube. The one or more dimples may be located along the length. For example, the tube may include dimples that are spaced apart from the proximal end to the distal end so that the endoscope and sheath are fully supported relative to each other along their length. If more than one dimple is present the dimples may be located adjacent, in the same plane, in a line, be axially spaced apart, radially spaced apart, or a combination thereof. The one or more dimples may be located on the same side of the sheath as the port, opposite side of the sheath as the port, or both.

The port may function to provide access into the tube of the sheath. The port may function to provide a fluid connection, a connection with one or more irrigation sources, a connection with one or more suction sources, one or more common lines, one or more delivery lines, or a combination thereof. The port may form a fixed connection with one or more lines so that suction, irrigation fluid, or both may be provided through the port. The port may provide direct access to the inside of the tube. The port may be configured so that one or more functional elements (e.g., a cutting tool, a cauterizing tool, or both) may gain access to the inside of the tube of the sheath, may extend out of the distal end of the sheath, or both. For example, the port may receive items that do not flow. The port may be part of a handpiece of the sheath. The port may be part of the tube, the hub, or both.

The hub may function to connect the sheath to the endoscope. The hub may function to seal the sheath to the endoscope. The hub may surround a portion of the endoscope. The hub may function to create a fluid seal with the endoscope so that irrigation fluid, suction, or both do not leak. The hub may receive a shoulder of the endoscope so that the shoulder and the hub form a fluidly sealed connection. The hub may have a circular cross section. The hub may taper as it extends towards the distal end of the sheath. The hub may be large enough to receive all or a portion of the endoscope. The hub may partially extend around the endoscope, fully extend around the endoscope, or a combination of both. The hub may have a thicker section that connects to the tube. The hub may be fastened to the tube. The hub may be connected to the tube by a mechanical fastener such as threads, a snap, a one way connection system, a series of ribs, or a combination thereof. The hub may connect to the tube by one or more adhesives. The hub may include a collar, an arm, or both that receive all or a portion of the endoscope.

The collar may be an integral part of the hub. The collar may function to axially align, rotationally align, or both the endoscope and the sheath. The collar may form a majority of the hub (e.g., 50 percent or more, 60 percent or more, or 70 percent or more). The collar may function to prevent rotational movement. The collar may function to prevent axial movement. The collar may function to receive all or a portion of the endoscope. The collar may function to receive a light post of the endoscope. The collar may surround the light post. The collar may extend partially around the light post. The collar may include one or more flares that extend proximally from the collar.

The flare may function to create a sealed connection with the endoscope. The flare may create a fluid seal with the endoscope so that irrigation fluid, suction, or both cannot escape between the endoscope and the flare. The flare may be flexible so that the flare forms a seal. The flare may be elastically deformable so that the flare forms a compression fitting with the endoscope. The flare may be partially deformable, include a deformable region, include rubber, include an elastomer, include elastic, or a combination thereof. The flare may be axially compressed when the endoscope is inserted in the sheath. The flare may form a circumferential seal about a shoulder of the endoscope, an end of the proximal end region, around the tube, or a combination thereof. The flare may axially extend from the hub of sheath. The flare may radially extend from the hub. The flare may be located partially within the hub and partially out of the hub. The flare may have a facing surface that contacts an endoscope.

The facing surface may function to create a seal with an endoscope. The facing surface may contact a shoulder of the endoscope. The facing surface may create a seal with the endoscope, the shoulder of the endoscope, or both. The facing surface may surround a portion of the endoscope. For example, the facing surface may extend around the tube, the shoulder, or both to create a seal. The facing surface may be made of a pliable material that forms a seal. The facing surface may be made of an elastomer, may include an elastomer, or both. The facing surface may elastically deform. The facing surface may be longitudinally extendable. The length of the facing surface may be longitudinally extendable. The facing surface may extend from the hub. The facing surface may have a portion that extends radially outward. The hub may include one or more spacers.

The one or more spacers may function to axially align the endoscope within the sheath. The one or more spacers may contact a shoulder of the endoscope and align the endoscope within the sheath. The spacer may contact an endoscope so that the endoscope is axially aligned within the tube. The one or more spacers may be optional. The spacer may be located proximate to one or more O-rings.

The one or more O-rings may function to form a seal between the sheath and a tube of the endoscope. The one or more O-rings may function to prevent fluid from traveling towards the proximal end of the endoscope. The one or more O-rings may function to create a seal. The one or more O-rings may be located within the hub, proximate to a collar of the hub, or both. The one or more O-rings may be made of any material that forms a seal. The one or more O-rings may create a circumferential seal, a thrust seal, or both. The one or more O-rings may be axially compressed, radially compressed, radially expanded, or a combination thereof. The one or more O-rings may include one or more through holes. The one or more O-rings may elastically deform. The one or more O-rings may be made of an elastomer, include elastic, include rubber, include a deformable material, include a deformation region, or a combination thereof. The one or more O-rings may be located proximate to a locking ring.

The one or more locking rings may lock the O-ring to the sheath, the endoscope, or both. The one or more locking rings may function to lock two or more components together. The one or more locking rings may include a through hole so that the endoscope extends through the tube and the locking ring.

A through hole may extend from a proximal end to a distal end of the sheath. A through hole may be sufficiently large so that the endoscope and fluid (e.g., irrigation fluid, suction, or both) may pass from the distal end to the proximal end of the sheath. The tube may include one or more through holes in the sheath. The through hole in the tube may open directly to a point of interest, an internal location of a patient, or both. The through hole may include one or more flow directors.

The one or more flow directors may function to direct fluid from the distal end of the sheath, suction at the distal end of the sheath, or both. The one or more flow directors may function to direct irrigation fluid across an imaging device, into contact with an imaging device, at an angle relative to an imaging device, or a combination thereof. The one or more flow directors may be part of the tube. The one or more flow directors may be a discrete piece. The one or more flow directors may be partially part of the tube and partially a discrete piece. The one or more flow directors may be an extension. The one or more flow directors may be formed by bending, cutting, folding, or a combination thereof. The one or more flow directors may be made of metal, plastic, a biocompatible material, or a combination thereof. The one or more flow directors may be formed by removing material. The one or more flow directors may be formed by grinding, cutting, or both. The one or more flow directors may be formed by performing more than one of the aforementioned manufacturing steps. For example, the material may be folded and then polished so that there are no sharp edges. The one or more flow directors may be made by molding, injection molding, or both. The one or more flow directors may be a lip, a flexible flap, end plug, or a combination thereof.

The one or more end plugs may function to direct fluid from a distal end of a sheath. The one or more end plugs may function to direct irrigation fluid, suction, or both across an imaging device, the face of the endoscope, a viewing lens of the endoscope, or a combination thereof. The one or more end plugs may direct irrigation fluid, suction, or both at an angle relative to the endoscope, viewing lens, face, or a combination thereof. The one or more end plugs may connect to an inner wall of the sheath, an outer wall of the sheath, or both the inner wall and the outer wall of the sheath. The one or more end plugs may be integrally formed with the sheath. The one or more end plugs may be discrete from the sheath and connected to the tube of the sheath. The one or more end plugs may connect to a distal end region of the sheath. The one or more end plugs may include one or more radially extending lips.

The one or more radially extending lips may function to direct fluid entering and/or exiting the one or more end plugs, the sheath, a tube of a sheath, or a combination thereof. The one or more radially extending lips may function to angle fluid and/or suction across the endoscope, the imaging device, a face, a viewing lens, or a combination thereof. The one or more radially extending lips may direct the fluid at an angle relative to the longitudinal axis of the sheath. The one or more radially extending lips may extend substantially around a circumference of the sheath. The one or more radially extending lips may extend around about 30° or more, about 45° or more, about 60° or more, about 90° or more, or even about 135° or more. The one or more radially extending lips may extend around about 360° or less, about 270° or less, preferably about 180° or less, or even more preferably about 150° or less. The one or more radially extending lips may extend from a distal end of the end plugs. The radially extending lip may form a top side of a channel. The radially extending lip may extend in both the axial direction and an angle relative to the axial direction (e.g., perpendicular). The one or more lips may direct fluid across the distal end of the endoscope, the imaging device, a facing surface a viewing lens, or a combination thereof. The angle the fluid may be directed by the one or more lips is about 30° or more, about 45° or more, about 60° or more, or about 75° or more (e.g., about 90°). The angle the fluid may be directed by the one or more lips is about 180° or less, about 150° or less, about 135° or less, or about 115° or less. The one or more radially extending lips may extend over one or more channels, create one or more channels, or both.

The one or more channels may function to provide a fluid path at a distal end region of the sheath. The one or more channels may direct irrigation fluid, suction, or both relative to the endoscope. The one or more channels may extend from a proximal end to a distal end of the end plug. The one or more channels may have any shape so that fluid flows through the channels. The one or more channels may have a continuous cross sectional area, cross-sectional shape, cross-sectional size, or a combination thereof. The one or more channels may taper as the channel approaches the distal end. The one or more channels may increase in size and the channel approaches the distal end. The one or more channels may be a single channel. The height, width, thickness, or a combination thereof of the channel may vary as the channel radially extends around the sheath, endoscope, or both. For example, the channel may start with a first dimension at a first end and a second dimension at a second end where the first dimension is a factor of two or more, three or more, or even four or more than the second dimension at the second end. The cross-sectional area of the channel may vary along the length of the channel. The size of the channel may exponentially increase in size as the channel extends around the circumference. The channel may provide different flow rates, flow pressures, flow forces, or a combination thereof along the circumference of the endoscope. The channel may be formed between two opposing surface. The channel may be formed between a lip and a cross-bar.

The cross-bar may function to form all or a portion of a channel. The cross-bar may function to provide radial support, axial support, or both of the lip, the connection arms, the front wall, or a combination thereof. The cross-bar may function to create a connection with an endoscope, a sheath, or both. The cross-bar may have a uniform thickness, length, width, or a combination thereof. The cross-bar may vary in thickness, length, width, or a combination thereof. The cross-bar may substantially mirror the shape of the endoscope, sheath, or both. The cross-bar may be made of one piece. The cross-bar and the lip may be connected together, part of one unitary piece, or both. The cross-bar and lip may be two discrete pieces. The cross-bar may be covered by the lip in the axial direction. The cross-bar may be partially covered or fully covered at one end. The cross-bar may be open at a distal end of the end plug. The cross-bar may terminate before the lip and a front wall may extend in front of the channel, the cross-bar, or both at an angle relative to the axial direction.

The front wall may be a part of the lip. The front wall may function to change the direction of fluid flow. The front wall may direct fluid across the front of the endoscope. The front wall may function to direct irrigation fluid across a lens, an imaging device, distal end, or a combination thereof of an endoscope. The front wall may direct fluid from one side to a second opposing side. The front wall may be tapered so that irrigation fluid flow is equally distributed across the endoscope, more irrigation fluid is applied in a central portion, or both. The front wall may vary in angle so that irrigation fluid flow is varied across the endoscope. The front wall may direct irrigation fluid at an angle of about 135 degrees or less, about 105 degrees or less or about 95 degrees or less relative to the axial direction, the first direction of flow, or both. The front wall may direct irrigation fluid at an angle of about 45 degrees or more, about 60 degrees or more, or about 75 degrees or more relative to the axial direction, the direction of flow, or both. Preferably, the front wall may direction irrigation fluid at substantially a 90 degree angle relative to the axial direction, the first direction of flow, or both. The front wall may direct irrigation fluid, suction, or both from a first direction to a second direction so that the endoscope is cleaned. The front wall may extend from, be connected to, or include one or more connection arms.

The one or more connection arms may function to connect the end plug to the sheath. The one or more connection arms may function to connect the end plug to the endoscope. The one or more connection arms may function to connect the end plug to a sheath so that a force is prevented from moving the end plug axially, radially or both on the sheath. The one or more connection arms may function to create a force so that the end plug is prevented from moving axially, radially, or both on the endoscope. The one or more connection arms may extend partially and/or fully around the sheath, the endoscope, or both. The one or more connection arms may create a radial force on the sheath, the endoscope, or both. The one or more connection arms may be integrally connected to the sheath. The one or more connection arms may be connected to the sheath by a fastener. The one or more fasteners may be a rivet, a screw, a set screw, a threaded member, a detent, a one sided locking member, or a combination thereof. For example, a one sided locking member may be ramp shaped and when slid over the ramp the one sided locking member may prevent the end piece from being moved in an opposing direction. The one or more connection arms may be connected to the sheath by an adhesive. The one or more connection arms may be mechanically connected (e.g., ultrasonically welded, friction welded, resistive welded, heat staking, or a combination thereof) to the endoscope, sheath, or a combination of both. The connection arms may be heat shrinkable. The connection arms may be adjustable so that the length of the connection arms are shortened to form a fixed connection with the sheath, the endoscope, or both. The one or more connection arms may form a receiving region between the one or more connection arms.

The receiving region may function to receive the sheath, the endoscope, or both. The receiving region may function to form a fixed connection with the sheath, the endoscope, or both. The receiving region may be generally circular in shape. The receiving region may be substantially the same shape as the endoscope, the lumen or both. The receiving region may extend into a recess in the sheath, the endoscope, or both. The receiving region may be a through hole, an absence of material, or both. The receiving region may be shrinkable, variable in size, or both. The receiving region may be shaped so that the end plug may be extended over the sheath and a fixed connection formed. The sheath may include one or more lumen.

The sheath may be a multi-lumen sheath. The multi-lumen sheath may function to provide a through hole for the endoscope and one or more through holes for fluids (e.g., irrigation fluid, suction, or both). The multi-lumen sheath may function to provide access from a proximal end to a distal end of the sheath. The multi-lumen sheath may function to provide access for one or more fluids, one or more functional devices, or both. The multi-lumen sheath may include at least two lumen that extend through the sheath. Each of the lumen include a proximal end and a distal end. Each of the proximal ends and distal ends of each of the lumen may be align. Each of the proximal ends, the distal ends, or both may be the same length, different lengths, or both. The proximal ends, distal ends, or both may end at different locations so that one lumen extends past one or more of the other lumen. The multi-lumen sheath may include at least a first lumen and a second lumen.

The first lumen may function to receive all or a portion of the endoscope. The first lumen may function to receive at least the distal end of the endoscope. The first lumen may function to extend substantially the length of the sheath, the tube of the sheath, or both. The first lumen may be the largest lumen of the sheath. The first lumen may be the primary lumen of the sheath. The first lumen may have a cross-sectional area that is a factor of 2 or more, 3 or more, 4 or more, or even 5 or more larger than the second lumen or any other lumen. The first lumen may extend from substantially the proximal end to substantially the distal end. The first lumen may be substantially the same size as the endoscope. The first lumen may be separated by the other lumen (e.g., the second lumen) by a wall.

The second lumen may function to receive fluid, a functional tool, or both. The second lumen may function to assist in cleaning an endoscope. The second lumen may provide access from substantially the proximal end to substantially the distal end of the sheath. The second lumen may be located only at the distal end region (i.e., last 20 percent or less), only at the proximal end region (i.e., last 20 percent or less), extend the entire length of the sheath, extend the entire length of the tube, or a combination thereof. Preferably, the second lumen is only located within the distal end region of the tube of the sheath. The second lumen may have a different length then the first lumen. The second lumen may terminate at a location where the second lumen can provide irrigation fluid, suction, or both to the distal end of the endoscope, clean the endoscope, or both. The second lumen and the first lumen may be generally parallel. The second lumen may include a portion that directs fluid towards the first lumen, the endoscope, or both. The second lumen may have a portion that is angled towards the first lumen, the endoscope, or both. The second lumen may be formed by a space created between a wall of the tube and the endoscope, one or more inner walls, or both.

The one or more inner walls may function to create two or more lumen. The one or more inner walls may function to separate two or more lumen. The one or more inner walls may be a continuous wall, an intermittent wall, a solid wall, a perforated wall, or a combination thereof. The one or more inner walls may be located only at the distal end region (i.e., the last 20 percent or less), only at the proximal end region (i.e., the last 20 percent or less), extend the entire length of the sheath, extend the entire length of the tube, or a combination thereof. The one or more inner walls may form separate channels within the tube of the sheath. The one or more inner walls may bias the endoscope into contact with an opposing wall of the sheath. The one or more inner walls may form a tight fit with the endoscope at a location along its length. Preferably, the inner wall contacts the distal end of the endoscope so that the distal end is located within the sheath. The one or more inner walls may function to provide a channel for fluids to pass but not interfere with the endoscope. The one or more inner walls may include one or more weep ports.

The one or more weep ports may be a through hole in the inner wall. The one or more weep ports may function to direct irrigation fluid, suction, or both across a distal end of the endoscope. The one or more weep ports may function to clean an endoscope, dry an endoscope, remove opaque substances from a viewing lens, a visual port, a viewing face, or a combination thereof of an endoscope. The one or more weep ports may flow fluid across an endoscope. The one or more weep ports may be a through hole in an inner wall of the sheath tube. The one or more weep ports may be any shape so that fluid, suction, or both are directed along a distal end of the endoscope. The one or more weep ports may be circular, oval, square, rectangular, extend around a circumference of the tube, or a combination thereof. The one or more weep ports may extend between the first lumen and the second lumen. The one or more weep ports may allow irrigation fluid to flow into the first lumen from the second lumen so that the end of the endoscope is flooded with fluid and then when vacuum is applied the excess fluid is removed. The one or more weep ports may be located proximate to and/or work in conjunction with one or more lavage ports.

The one or more lavage ports may function to provide irrigation fluid to a location distal from the sheath the endoscope or both. The one or more lavage ports may function to clean a feature of interest while the endoscope is cleaned. The one or more lavage ports may reduce the pressure of the irrigation fluid extending out of the weep port. The one or more lavage ports may extend from the second lumen, extend through an end plate covering the second lumen, or both. The one or more lavage ports may irrigate a site of interest (e.g., a surgical site). The one or more lavage ports may remove debris, opaque substances, or both from a site of interest. The one or more lavage ports may allow for a functional tool (e.g., a gripping tool, a cauterizing tool, a cutting tool, or a combination thereof) to extend through the sheath and into the site of interest.

FIG. 1A illustrates a top view of sheath 90 for use with an endoscope cleaner system (not shown). The sheath 90 includes a distal end 92 and a proximal end 94. A tube 96 and hub 98 extending between the distal end 92 and the proximal end 94. The hub 98 includes a port 106 for receiving suction, an irrigation fluid, or both, and a collar 100 for creating a connection with an endoscope (not shown).

FIG. 1B illustrates an end view of the sheath 90 from the proximal end 94. The port 106 is shown extending from the hub 98 and a through hole 152 is shown extending through the tube 96 and hub 98.

FIG. 1C illustrates a view of the sheath 90 from the distal end 92. A through hole 152 is shown extending through the sheath 90.

FIG. 2 illustrates a cross sectional view of the sheath 90 of FIG. 1A cut along lines A-A of FIG. 1C. The sheath 90 includes a tube 96 connected to a hub 98. The hub 98 includes an optional spacer 128 between an end of the tube 96 and a mating surface of the hub 98. An O-ring 130 is located in the hub proximate to a locking ring 132 for creating connection between the hub 98 and an endoscope (not shown).

FIG. 3A illustrates an endoscope 60 extending into a sheath 90. The endoscope 60 includes a proximal end 64 including a visual port 74. The endoscope 60 includes a distal end 92 that extends to a distal end 62 of a sheath 90, and a viewing cone 78 of the endoscope is shown. The sheath 90 includes a tube 96 extending from a distal end 92 to a hub 98. The hub 98 includes a port 106 for receiving suction, an irrigation fluid, or both. The hub 98 terminates at a proximal end 94 that receives a shoulder 70 and a light port 72 of the endoscope 60.

FIG. 3B illustrates an end view of the sheath 90 and endoscope 60 from a distal end view 62, 92. The visual port 74 and light post 72 of the endoscope 60 extend outward from the endoscope 60 at the proximal end 64.

FIG. 3C illustrates a close up end view of the distal end 92 of the sheath 90 of FIG. 3B. The sheath 90 includes a viewing face 114 proximate to a viewing lens 76 of an endoscope 60 (as illustrated the viewing lens 76 is a 45 degree lens). The sheath 90 includes a flow director 158 that is a flexible flap 118 which is located between the sheath 90 and the endoscope 60. The flexible flap 118 is at least partially openable and closeable so that fluid can be directed across the viewing scope 76 of the endoscope 60. The flexible flap 118 is free of extension over the viewing lens 76 of the endoscope 60 so that vision of the endoscope 60 is not impeded by the flexible flap 118.

FIG. 3D illustrates a close up side view of a sheath 90 of FIG. 3A. The sheath 90 includes a distal end 92 with a viewing face 114 so that the endoscope can view through the sheath 90 as is illustrated by viewing cone 78. The sheath 90 includes a slot 116 that receives a portion of a flexible flap 118. The flexible flap 118 extends between an endoscope 60 and the sheath 90.

FIG. 3E illustrates a close-up view a distal end 92 of the sheath 90 of FIG. 2. The distal end 92 includes a slot 116 that extends through the sheath 90 and receives a flexible flap 118. The sheath 90 includes a dimple 134 along its length that contacts an endoscope (not shown) so that the endoscope is moved and a gap is formed in a selected region between the endoscope and sheath 90. The gap creates a lumen and/or conduit between the endoscope and the sheath for fluid to travel through.

FIG. 3F illustrates a perspective view of a sheath 90 and an endoscope 60. The endoscope 60 as illustrated has a viewing lens 76 with a 0 degree angle and a flexible flap 118 that extends between the sheath 90 and the endoscope 60. A portion of the flexible flap 118 extends through a slot 116 in the sheath 90 so that a connection is formed between the flexible flap 118 and the sheath 90.

FIG. 3G illustrates a perspective view of a slot 116 in the tube 96 of a sheath 90.

FIG. 3H illustrates a bottom perspective view of a flow director 158 that is configured as a flexible flap 118 that substantially mirrors an angle of an endoscope (e.g., 75 degree angle as shown). The flexible flap 118 includes a flap connector 300 that extends through a slot (not shown) in a tube of a sheath. The flap connector 300 extends from a flap body 302 and the flap body 302 includes a pair of flap directors 304 that are separated by an optional slot 306.

FIG. 4 illustrates a sheath 90 including a dimple 134 and a flow director 158. The dimple 134 is located along the length of the shaft 90 so that the endoscope is biased to one side of the sheath 90 forming a gap between the endoscope (not shown) and the sheath 90. The sheath 90 includes a longitudinal axis 95 that extends the length of the sheath 90. The distal end 92 of the sheath 90 includes a first opening 124 and the flow director 158 which is configured as a second opening 126 that extends in a direction 127 and forms an angle (a) with the longitudinal axis 95.

FIG. 5A-5B illustrate a sheath 90 having a first opening 124 and a second opening 126 at a distal end 92. FIG. 5A is a perspective view of the sheath 90. The sheath 90 includes a longitudinal axis 95 with a dimple 134 located along the longitudinal axis. The sheath 90 has a second opening 126 that extends in the direction 127 at an angle that is substantially parallel to the longitudinal axis 90. The angle the second opening 126 extends is a 0° angle relative to the longitudinal axis 95. FIG. 5B illustrates a distal end 92 view of the sheath 90 showing the shape of the first opening 124. The second opening 126 is located in the sheath and projects through the flange 136 that extends partially around an outer edge of the sheath 90.

FIGS. 6A-6B illustrate a sheath 90 having a first opening 124 and a second opening 126. FIG. 6A illustrates the second opening 126 extending in the direction 127 at an angle (β) relative to the longitudinal axis 95. The second opening 126 is a flow director 158 that directs flow from the sheath at the angle (β). The angle (β) as illustrated is a 60° angle, however, the angle may be a 0°, 30°, 45°, 50°, or 70°. FIG. 6B illustrates view of the proximal end 92 of the sheath 90. The sheath 90 includes a first opening 124 and a second opening 126. The second opening 126 is located in a flange 136 that extends partially around the sheath 90.

FIG. 7A illustrates a view of a flow director 158 that is an end plug 190 which can be connected to an end of a sheath 90 (not shown) to control flow of an irrigation fluid (not shown). The end plug 190 includes a radially extending lip 192 that extends over a cross bar 196 creating a channel 194 therebetween. The channel 194 terminates at a front wall 198 that changes the direction of the fluid and distributes the fluid to a selected location. The end plug 190 includes a pair of opposing connection arms 202 that include a receiving region 204 therebetween for receiving and connecting to a distal end of an endoscope (not shown).

FIG. 7B is a cross-sectional view of FIG. 7A along lines 7B-7B. The flow director 158 when configured as an end plug 190 includes a radially extending lip 192 extending above a cross bar 196 forming a channel 194 therebetween. The channel 194 turns at a front wall 198 so that fluid extends in the direction 200 and then turns in the direction 200′. A receiving region 204 forms a through hole that extends between two opposing connection arms 202 that form a connection with an endoscope (not shown).

FIGS. 8A1 through 8D illustrate a sheath 90 that is a multi-lumen sheath 160. The sheath 90 is connected to a hub 98 that includes a port 106 for ingress and egress of fluids. FIG. 8A1 illustrates a cross-sectional view of a multi-lumen sheath 160. A proximal end 94 of the sheath 90 includes a flare 110 with a facing surface 112 extending therefrom. The hub 98 includes a port 106 and the hub 98 is connected to a tube 96. The tube 96 has a first lumen 168 having a length 170 and a second lumen 172 having a length 174 that are different so that the first lumen 168 extends beyond the second lumen 172 in the proximal end 94 direction. The first lumen 168 and the second lumen 172 are separated by an inner wall 176.

FIG. 8A1 illustrates a close-up view of the first lumen 168 and the second lumen 172 of the multi-lumen sheath 160. The first lumen 168 and the second lumen 172 are separated by an inner wall 176. The inner wall includes a weep port 182 that moves fluid across a distal end of an endoscope (not shown) to clean the endoscope. A lavage port 184 is located in the end of the sheath 160 at the end so that fluid may extend out of the end to irrigate an area surrounding the sheath 160.

FIG. 8A2 illustrates a close up view of the distal end 92 of the multi-lumen sheath 160 of FIG. 8A1. The multi-lumen sheath 160 includes an inner wall 176 that creates a first lumen 168 and a second lumen 172. The inner wall 176 includes a weep port 182 extend there through. A lavage port 184 extends through the distal end of the multi-lumen sheath 160 so that fluid can flow out the distal end of the multi-lumen sheath 160.

FIG. 8B illustrates cross-sectional view the sheath 90 of FIG. 8A2 cut along line 8B-8B. As illustrated the first lumen 168 and the second lumen 172 are separate and the inner wall 176 extends there between.

FIG. 8C is an end view of the sheath 90 of FIG. 8A2 when viewed from the end along line 8C-8C. As illustrated only the first lumen 168 is visible and the second lumen 172 is connected to a lavage port 184 that extends through the distal end 92 of the sheath 90.

FIG. 8D illustrates a perspective view of the multi-lumen sheath 160. The end of the multi-lumen sheath 160 includes an inner wall 176 that creates and separates a first lumen 168 and a second lumen 172. The inner wall 176 includes a weep port 182 that allows irrigation fluid and/or suction to extend from the second lumen 172 into the first lumen 168 to clean an endoscope (not shown). A lavage port 184 extends from an end of the second lumen 172 and the sheath 160 so that irrigation fluid and/or suction can be applied from the distal end.

FIG. 9 illustrates an endoscope cleaning system 2. The endoscope cleaning system 2 includes an irrigation source 4 connected to an irrigation line 6 that is connected to a control module 30 that includes a pump 14 for controlling flow of irrigation fluid between the irrigation source 4 and a sheath 90. The control module 30 includes a power source 20 and a controller and/or microprocessor (not shown) that is in communication with a user interface 31 for controlling the control module 30. The system 2 includes a suction source 10 that is connected to the control module 30. The control module 30 includes a valve 8 in the suction line that is connected to a sheath 90, which receives a portion of an endoscope. The valve 8 for controls suction between the suction source 10 and the sheath 90 so that suction may be turned off during all or portion of the application cycle of the irrigation fluid. The irrigation line 6 and the suction line 12 are connected together at a common fitting 16 that connects the irrigation line 6 and the suction line 12 to a common line 18/delivery line 42 for supplying a fluid or suction to the sheath 90 for cleaning an endoscope (not shown).

FIG. 10 illustrates a control module 30 that includes a pump 14, a power source 20, a user interface 31, and one or more valves 8. The irrigation source 4 is gravity fed into the pump 14 and then the pump 14 sends fluid through the irrigation line 6 to the sheath 90 so that the sheath 90 washes the endoscope 60. The suction source 10 is connected to a valve 8 of the control module 30 that controls suction being drawn through the suction lines 12. Both the irrigation lines 6 and the suction lines 12 are connected to a common fitting 16 and a single common line 18/delivery line 42 extend from the common fitting 16 to the sheath 90. The suction line 12 may include a valve 8 that is a passive check valve to prevent irrigation fluid from being forced into the suction line.

Any numerical values recited herein include all values from the lower value to the upper value in increments of one unit provided that there is a separation of at least 2 units between any lower value and any higher value. As an example, if it is stated that the amount of a component or a value of a process variable such as, for example, temperature, pressure, time and the like is, for example, from 1 to 90, preferably from 20 to 80, more preferably from 30 to 70, it is intended that values such as 15 to 85, 22 to 68, 43 to 51, 30 to 32 etc. are expressly enumerated in this specification. For values which are less than one, one unit is considered to be 0.0001, 0.001, 0.01 or 0.1 as appropriate. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application in a similar manner.

Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints. The use of “about” or “approximately” in connection with a range applies to both ends of the range. Thus, “about 20 to 30” is intended to cover “about 20 to about 30”, inclusive of at least the specified endpoints.

The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. The term “consisting essentially of” to describe a combination shall include the elements, ingredients, components or steps identified, and such other elements ingredients, components or steps that do not materially affect the basic and novel characteristics of the combination. The use of the terms “comprising” or “including” to describe combinations of elements, ingredients, components or steps herein also contemplates embodiments that consist essentially of the elements, ingredients, components or steps. By use of the term “may” herein, it is intended that any described attributes that “may” be included are optional.

Plural elements, ingredients, components or steps can be provided by a single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step might be divided into separate plural elements, ingredients, components or steps. The disclosure of “a” or “one” to describe an element, ingredient, component or step is not intended to foreclose additional elements, ingredients, components or steps.

It is understood that the above description is intended to be illustrative and not restrictive. Many embodiments as well as many applications besides the examples provided will be apparent to those of skill in the art upon reading the above description. The scope of the teachings should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. The omission in the following claims of any aspect of subject matter that is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventors did not consider such subject matter to be part of the disclosed inventive subject matter.

Claims

1. An endoscope sheath comprising:

a tube having: a proximal end having a proximal end region and a distal end; and

a conduit that extends through a portion of the endoscope sheath so that the proximal end region of the endoscope sheath and the distal end of the endoscope sheath are in fluid communication when an endoscope is inserted inside the endoscope sheath; and

wherein the endoscope sheath is configured to receive all or a portion of the endoscope;

wherein the distal end of the endoscope sheath has a flow director configured to direct irrigation fluid across a lens on the distal end of the endoscope; and

wherein the flow director is a flexible flap.

2. The endoscope sheath of claim 1, wherein the tube includes a slot and at least a portion of the flexible flap extends through the slot.

3. The endoscope sheath of claim 2, wherein the flexible flap is free of extension across a viewing lens, a viewing port, or both of the endoscope so that optics of the endoscope are not impeded by the flexible flap.

4. The endoscope sheath of claim 1, wherein the flexible flap is sufficiently flexible so that movement of fluid from the endoscope sheath moves the flexible flap to an open position.

5. The endoscope sheath of claim 1, wherein the flexible flap is elastically deformable or sufficiently rigid so that the flexible flap is self-closing after a fluid apply.

6. The endoscope sheath of claim 1, wherein the flexible flap covers the conduit or a portion of the conduit when the flexible flap is in the closed position.

7. An endoscope sheath comprising:

a proximal end having a proximal end region and

a distal end;

a conduit creating fluid communication between the proximal end region of the endoscope sheath and the distal end of the endoscope sheath when an endoscope is inserted inside the endoscope sheath; and

a flow director at the distal end of the endoscope sheath; and

wherein the distal end of the endoscope sheath has a first hole sized to fit around a distal end of the endoscope and at least partially align with a viewing lens, a visual port, or both of the endoscope so that the endoscope can view features of interest through the first hole, and

wherein the flow director is configured as a flange including one or more second holes that are configured to direct irrigation flow distally from the endoscope and into a surgical site.

8. The endoscope sheath of claim 7, wherein the endoscope sheath includes a longitudinal axis and the one or more second holes extends substantially parallel to the longitudinal axis.

9. The endoscope sheath of claim 7, wherein the endoscope sheath includes a longitudinal axis and the one or more second holes extends at an angle of about 15 degrees or more or about 90 degrees or less from the longitudinal axis.

10. The endoscope sheath of claim 9, wherein the endoscope sheath includes a longitudinal axis and the one or more second holes extends at an angle from about 30 degrees to about 75 degrees.

11. The endoscope sheath of claim 7, wherein the second hole is round, oblong, a slit, or a combination thereof.

12. The endoscope sheath of claim 7, wherein the flow director is a separate piece that connects to a distal end of the endoscope sheath.

13. The endoscope sheath of claim 12, wherein the flow director includes a pair of connecting arms that grip the endoscope sheath and form a fixed connection with the distal end of the endoscope sheath.

14. An endoscope sheath comprising:

a proximal end and

a distal end;

a flow director connected to the distal end of the endoscope sheath, the flow director including: one or more connection arms that form a fixed connection with an endoscope, a endoscope sheath, or both; a channel extending through the flow director that directs flow of an irrigation fluid across a distal end of the endoscope; and

wherein flow of the irrigation fluid is changed from a first direction to a second direction by the flow director.

15. The endoscope sheath of claim 14, wherein the channel extends between a radially extending lip and a cross bar.

16. The endoscope sheath of claim 14, wherein a front wall changes the flow of the irrigation fluid from the first direction to the second direction so that the flow is directed across a face of an endoscope.

17. The endoscope sheath of claim 14, wherein an area of the channel varies along its length.

18. The endoscope sheath of claim 14, wherein a width of the channel at one end is narrower than a width of the channel at an opposing end.

19. The endoscope sheath of claim 14, wherein the flow director is offset from the distal end of the endoscope sheath so that a center of an opening of the endoscope sheath and a center of the flow director are offset.