Methods and apparatuses for identifying leaks in endoscope shields

Abstract

Methods and apparatuses for identifying leaks in endoscopic shields may include a leak testing device configured for coupling to an endoscopic shield device. The device may include a body that includes an interface that includes a seal configured to fluidly isolate an internal cavity of the endoscopic shield device. A chamber of the device may be configured to enclose a proximal end or ends of an internal shield of the endoscopic shield device. A pressure port of the device can be used to pressurize the internal cavity of the endoscopic shield device such that any leakage defects of the endoscopic shield device can be detected by leakage of the fluid (e.g., water, air, vacuum) from the pressurized internal cavity of the endoscopic shield device.

Description

METHODS AND APPARATUSES FOR IDENTIFYINGLEAKS IN ENDOSCOPE SHIELDSCLAIM OF PRIORITY

[0001] This patent application claim priority to U.S. provisional patent application no. 63 / 724,269, titled “METHODS AND APPARATUSES FOR IDENTIFYING LEAKS IN ENDOSCOPE SHIELDS” and filed on 11 / 22 / 2024, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0003] Endoscopes are used to view inside a body and typically include a long thin tube with lighting and a imaging device (e.g., camera) at the distal end. In some cases, the endoscopes are reusable and must be thoroughly cleaned and disinfected after use and before reuse. However, endoscopes are difficult to clean because they typically have a long length, may have multiple lumens, and may include a multitude of small, ornate parts constructed from a wide variety of materials with regions that may shelter microbes. Flexible endoscopes can be particularly difficult to clean, because they can be very long (up to 2 meters in length) and because they are built from plastics and elastomers that offer less durability than their (metal) rigid endoscope counterparts. Microbe sheltering regions may include areas where multiple parts of the endoscope meet, in cracks and connections, and regions where there are scratches and localized damage. Often, endoscopes are inserted into pathogen-rich environments, such as blood, feces, urine, and diseased and infected tissue. Reusable endoscopes are expected to survive a very large number of cases - often over one thousand - over a long period of time, e.g., several years.However, such long-life expectations create issues: a careful analysis of endoscopes shows them to be often damaged both internally and externally. The repair of endoscopes is logistically taxing, requires constant quality-control and inspection, requires expensive back-up devices, shipping, receiving and proper packaging and transport, and is very expensive: a reusable scope typically has lifetime repair costs that equal the cost of the initial purchase. Because reusableendoscopes are expected to last for years, it inherently means that clinicians are performing endoscopy with outdated technology.

[0004] Cleaning endoscopes also requires considerable capital equipment, as well as their requisite space, training, maintenance, and repair. Successful cleaning of endoscopes requires the successful execution of highly detailed procedures often by staff that have significant turnover, are ill-trained, are hurried, are in poor communication with the end-user, and are working without all of the necessary tools. Further, despite the impression that re-use is good for the environment, the cleaning of endoscopes creates a remarkably large amount of landfill - gloves, wipes, brushes, personal protective gear, connectors, tubing, test strips, and hazardous chemicals. The chemical cleaning agents are harsh for the scope, the facility, the environment, and the people performing the cleaning.

[0005] Importantly, such cleaning processes may clean an endoscope, but the processed endoscope is not sterile (the goal is HLD, High Level Disinfection), because many of the endoscope’s materials cannot withstand the rigors of the requisite chemicals, temperatures, or radiation. Sterilization via ethylene oxide would require long exposure and aeration times, is hazardous to personnel and patients, and has created a large number of very public recent adverse worker health and environmental issues. Sterilization via peroxide is new and promising, but it would still suffer from the majority of above-listed maladies. In the worst case, peroxidesterilized devices would be sterile, but would still maintain debris burden which could be transferred from case-to-case. Endoscope contamination is pervasive and, in the worst cases, has resulted in disease transmission and documented deaths.

[0006] Surgical drapes and shrouds are effectively used to create a sterile field around a surgical site and establish a physical barrier that reduces the risk of device contamination and surgical site infections. Similarly, hygienic draping or sheathing can be applied to endoscopes. Sheathing can free technicians to pursue more important work, as they are no longer required to clean waste (e.g., feces) from endoscope. Sheathing, including for both manual and robotic / telerobotic endoscopy, may effectively physically isolate the device from the patient during surgical procedures. However, improvements over existing sheathing technology are needed. As such, a new class of devices known as shields have been proposed that offer multiple benefits including multiple layers of protection, armoring with fibers and metal, and with sealable internal and external protection elements. Shields may be configured to be rigidized by the application of pressure; thus, it may be particularly helpful to test for pressure leaks in these apparatuses, and to insure that the endoscope is or has been adequately protected.

[0007] Thus, there is a need for methods, components and apparatuses to address these issues.SUMMARY OF THE DISCLOSURE

[0008] Described herein are methods and apparatuses (e.g., devices, systems or assemblies) for identifying leaks in endoscopic shield devices. The methods and apparatuses are well suited for testing endoscopic shield devices for endoscopes but may also be suitable for testing sheaths and endoscopic shields for other catheter devices. Methods may include coupling a leak testing device to the endoscopic shield device, optionally immersing the device, pressurizing the endoscopic shield device, and checking for signs of leakage. The device may include features that is configured to accommodate features of a rigidizing endoscopic shield device.

[0009] In general, the endoscopic shield device may form an impermeable contamination barrier, which may be impermeable to fluid and / or solids. The endoscopic shield may be sterile or sterilized. Optionally the endoscopic shield does not have to be sterile, but may be clean and may prevent contamination of the endoscope to which it is attached. The endoscope does not need to be sterile or remain sterile, but may be kept clean and free of contaminants by the shield devices described herein. In particular both external and internal (e.g., channels, lumen, etc.) of the endoscope may be kept clean and free of contaminants as the shield devices described herein may effectively generate a barrier to prevent contamination. Importantly, the endoscopic shield devices are configured to be removed without contamination of the endoscope covered by the endoscopic shield device, either externally or internally.

[0010] The leak testing devices described herein are configured to isolate and pressurize the endoscopic shield device. The leak testing device may include a body configured to couple to a proximal end region of the endoscopic shield device. The body includes an interface including a seal that is configured to fluidly isolate the tubular cavity of the endoscopic shield device. The body also includes a chamber that is configured to enclose at least one proximal end, including at least one internal shield of the endoscopic shield device. The leak testing device also includes a pressure port that is configured to provide fluid access to the tubular cavity of the endoscopic shield device when the body is coupled with the endoscopic shield device, such that fluid can enter the tubular cavity of the endoscopic shield device via the pressure port to pressurize the tubular cavity of the endoscopic shield device, and such that any leakage defects of the endoscopic shield device can be detected by leakage of the fluid from the pressurized tubular cavity of the endoscopic shield device.

[0011] In general, the methods described herein may include immersing the shield device (before or after removal from the endoscope) into a fluid (e.g., water) to test for leaking as described herein, e.g., looking for bubbles, etc. Alternatively or additionally, the shield device may instead be coated with a bubble-forming material (e.g., surfactant, gel, etc.) that may form bubbles indicating a leak, tear, etc.

[0012] The leak testing device may be configured to be coupled with a port adapter at a proximal end of the endoscopic shield device. The leak testing device may include a lock that is configured to lock the device to the proximal end region of the endoscopic shield device in a sealed state. The leak testing device may include multiple seals that are configured to fluidically isolate the tubular cavity of the endoscopic shield device. The body may be configured to be coupled with a port adapter of the endoscopic shield device. The interface may include an outer interface portion that is configured to interface with an exterior surface of the port adapter, and an inner interface portion is configured to interface with an interior surface of the port adapter. The outer interface portion may include a first seal, and the inner interface portion may include a second seal. The interface may include a ring shape that corresponds to ring-shaped interface regions of the port adapter. The seal may be an annular seal. The external shield may include multiple layers that are configured to rigidize the external shield upon application of pressure between at least two of the layers, wherein the seal of the device is further configured to fluidically isolate one or more regions between the at least two of the layers of the external shield such that the fluid can pressurize the one or more regions between the at least two of the layers during pressurization of the tubular cavity of the endoscopic shield device.

[0013] In some examples, a method of leak testing an endoscope shield device includes sealing an opening at a proximal end of the internal shield of the endoscopic shield device; sealingly coupling a leak testing device to a proximal end region of the endoscopic shield device; pressurizing the chamber of the leak testing device and the tubular cavity of the endoscopic shield device; and checking for any leakage from the pressurized endoscopic shield device. Sealingly coupling the leak testing device to the proximal end region of the endoscopic shield device may include positioning sealed proximal end of the internal shield of the endoscopic shield device within a chamber of the leak testing device; and engaging an interface of the leak testing device with the endoscopic shield device such that the chamber of the leak testing device and the tubular cavity of the endoscopic shield device are in isolation together, wherein the interface provides an air tight seal between the leak testing device and the endoscopic shield device. The method of claim 19, wherein checking for any leakage comprises immersing the pressurized endoscopic shield device in a fluid and checking for any bubbles emanating from the pressurized endoscopic shield device. Given that the device may be buoyant, the methods and apparatuses described herein may ensure that the device is fully immersed under the testing fluid in some embodiments. The method may further include removing the endoscopic shield device from the endoscope prior to leak testing the endoscopic shield device. The leak testing may perform prior to use of the endoscopic shield device on an endoscope, after use of the endoscopic shield device on an endoscope, or both. Sealingly coupling the leak testing device to theendoscopic shield device may include activating a lock to lock the leak testing device to the proximal end region of the endoscopic shield device in a sealed state. The method may further include pressurizing one or more regions between two or more layers of the external shield as the chamber of the leak testing device and the tubular cavity of the endoscopic shield device are pressurized.

[0014] For example, described herein are leak testing apparatus for identifying that an endoscope shield has a leak that may include: a body configured to couple to a proximal end region of the endoscope shield, wherein the endoscope shield includes an external shield and at least one internal shield extending through a lumen of the external shield; a chamber within the body that is configured to receive at least a portion of the at least one internal shield; a seal interface configured to fluidly isolate the lumen of the external shield in communication with the chamber; and a pressure port that is configured to provide fluid access to the chamber, such that a fluid can be applied within the lumen of the external shield under pressurize to detect leakage of the fluid through the endoscope shield.

[0015] The body may be configured couple to a handle at a proximal end of the endoscope shield. For example, the body may include a lock configured to releasably secure the body to the proximal end region of the endoscope shield.

[0016] The seal interface may comprise an O-ring or other seal, including face seals, radial seals, o-ring boss seals, or other types of seals. The seal interface may comprise multiple seals arranged in series. The body may be configured to couple to a port adapter of the endoscope shield. The seal interface may comprise an outer interface surface that is configured to mate with an exterior surface of the port adapter, and an inner interface surface that is configured to mate with an interior surface of the port adapter. The outer interface surface may comprise a first seal, and the inner interface surface includes a second seal. The second seal may be an annular seal. Any of these apparatuses (or methods of using them) may include a port seal configured to seal a pressure port on a proximal end of the endoscope shield.

[0017] In some cases the apparatus may include the endoscope shield and / or endoscope. In particular, any of these apparatuses may include a rigidizing endoscope shield and / or endoscope.

[0018] For example, an apparatus may include: an endoscope shield comprising an external shield having a lumen configured to fit over an endoscope, an internal shield or shields configured to fit into the endoscope, and a cap configured to engage with a distal end of the endoscope to secure the endoscope shield over the endoscope; a leak testing apparatus configured to couple to the endoscope shield and comprising: a body configured to couple to a proximal end region of the endoscope shield; a chamber within the body that is configured to receive at least a portion of the internal shield extending proximal to the external shield; a sealinterface configured to fluidly isolate the tubular cavity of the endoscope shield; and a pressure port that is configured to provide fluid access to the chamber, such that a fluid can be applied within the lumen of the external shield under pressurize to detect leakage of the fluid through the endoscope shield.

[0019] The endoscope shield may be a rigidizing shield comprising a support layer, a rigidizing layer and a bladder layer, wherein the bladder layer is configured to be driven against the rigidizing layer by the application of pressure (positive, negative, or both) to rigidize the endoscope shield. The body may be configured to couple to a handle at a proximal end of the endoscope shield. As mentioned, any of these apparatuses may include a lock configured to releasably secure the body to the proximal end region of the endoscope shield. The seal interface may comprise an O-ring. In some cases, the seal interface comprises multiple seals arranged in series. The body may be configured to couple to a port adapter of the endoscope shield. The seal interface may comprise an outer interface surface that is configured to mate with an exterior surface of the port adapter, and an inner interface surface that is configured to mate with an interior surface of the port adapter.

[0020] The outer interface surface may comprise a first seal, and the inner interface surface includes a second seal. The second seal may be an annular seal. Any of these apparatuses may include a port seal configured to seal a pressure port on a proximal end of the endoscope shield.

[0021] Also described herein are methods of testing an endoscope shield for a leak, using any of these apparatuses. For example, a method may include: sealing a leak testing device to a proximal end of an endoscope shield; applying fluid within the leak testing device; and detecting any fluid leaking from the endoscope shield. Sealing the leak testing device may comprise coupling the leak testing device to the proximal end of the endoscope shield so that a sealed-off proximal end of an internal shield of the endoscope shield is within a chamber of the leak testing device. In some cases sealing the leak testing device comprises engaging a seal interface of the leak testing device with the endoscope shield such that a chamber of the leak testing device is in fluid communication with a lumen of the endoscope shield.

[0022] Any appropriate fluid may be applied. For example, applying fluid within the leak testing device may comprise pressurizing a chamber of the leak testing device. Checking for any leakage may comprise immersing the endoscopic shield in a liquid (for example, water) and checking for any bubbles emanating from the pressurized endoscopic shield device. Checking for any leakage may comprise checking for liquid emanating from the pressurized endoscopic shield in air.

[0023] Any of these methods may include removing the endoscope shield from an endoscope before sealing the leak testing device to the endoscope shield. In any of these methods sealingthe leak testing device may comprise activating a lock to lock the leak testing device to the proximal end region of the endoscope shield. Applying fluid within the leak testing device may comprise applying air within the leak testing device. For example, applying fluid within the leak testing device further comprises applying the fluid from a chamber of the leak testing device and between two or more layers of the endoscope shield.

[0024] Any of the methods described herein may be utilized in conjunction with methods used to ensure that the system - which may be buoyant - remains fully immersed in a liquid so that any bubbles could best be observed. For example, the apparatus may include weights or tethers to hold the shield submerged. For example these apparatus may include a net or netting material or a cage into which the shield may be inserted (coiled and / or extended. The net / netting material be weighted and / or tethered to the bottom of the bath. In some cases the apparatus may be part of a bath or chamber to hold fluid.

[0025] In some cases, the apparatus and methods described herein may detect a leak by detecting a change in pressure, without requiring submerging into a bath or adding a bubbleforming composition (e.g., water with surfactant, glycerol, etc.).

[0026] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.

[0027] These and other aspects and details are described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Novel features of embodiments described herein are set forth with particularity in the appended claims. A better understanding of the features and advantages of the embodiments may be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings.

[0029] FIGS. 1A-1C illustrate an example of an endoscope that may be used with the shield apparatuses described herein.

[0030] FIGS. 2A-2C illustrate an example of a telescoping assembly including an endoscope that may be used with the shield apparatuses described herein.

[0031] FIGS. 2D1 and 2D2 show an example of a portion of the rigidizing shield of FIGS. 2A-2C in both a flexible (FIG. 2D1) and rigid (FIG. 2D2) state. The bladder layer is formed of a single sheet or layer.

[0032] FIGS. 2D3 and 2D4 show an example of a portion of the rigidizing shield of FIGS. 2A-2C in both a flexible (FIG. 2D3) and rigid (FIG. 2D4) state, having an out-and-back bladder layer (e.g., formed of multiple sheets or layers).

[0033] FIGS. 3A-3C schematically illustrate examples of endoscope shields. FIG. 3A shows an example having a relatively short external shield that may be secured to the distal end region of an outer tube. FIG. 3B shows an example including a proximal attachment on the external shield. FIG. 3C shows an example having a long external shield that may extend beyond the length of the outer tube and / or endoscope member.

[0034] FIGS. 3D-3G illustrate an example of a system including an endoscope (FIG. 3D), a rigidizing shield (FIG. 3E), and an outer endoscope (FIG. 3F). FIG. 3G shows the assembly with an optional second rigidizing shield.

[0035] FIGS. 4A and 4B illustrate an example of an endoscopic shield (e.g., a rigidizing shield) for shielding an endoscope. FIG. 4A shows a perspective side view; and FIG. 4B shows a side view. FIGS. 4C and 4D shows the ends of the internal shields of the shield, before (FIG. 4C) and after (FIG. 4D) sealing them closed and flat.

[0036] FIGS. 5A and 5B illustrate an example of a leak testing device that is configured to mate with a port adapter of the endoscopic shield device in FIGS. 4A and 4B. FIG. 5A shows a side view; and FIG. 5B shows a front perspective view.

[0037] FIGS. 5C and 5D illustrate an example of the leak testing device in FIGS. 5A and 5B coupled with the port adapter of the endoscopic shield device in FIGS. 4A and 4B. FIG. 5C shows a side perspective view; and FIG. 5D shows a side view.

[0038] FIG. 6 A illustrates a section view of the shield apparatus in FIGS. 4A and 4B.

[0039] FIG. 6B illustrates an example section view of the leak testing device in FIGS. 5A and 5B that is coupled with the port adapter of the endoscopic shield device in FIGS. 4A and 4B.

[0040] FIGS. 6C and 6D illustrate an example partially transparent view of the leak testing device in FIGS. 5A and 5B coupled with the port adapter of the endoscopic shield device in FIGS. 4A and 4B. FIG. 6C shows a side perspective view; and FIG. 6D shows a side view.

[0041] FIG. 7 is a flowchart indicating a method of testing an endoscopic shield device for leaks.

[0042] FIG. 8 shows another example of a leak testing device coupled to a shield.

[0043] FIG. 9 shows an example of a leak testing device coupled to a shield.

[0044] FIGS. 10 A- 10C illustrate on example of a method of coupling a leak testing device, similar to that shown in FIG. 8, to a rigidizing shield.

[0045] FIGS. 11A-11C illustrate an example of a method of coupling a leak testing device, similar to that shown in FIG. 9, to a shield.DETAILED DESCRIPTION

[0046] The apparatuses (e.g., devices, systems and assemblies) and methods described herein may be used to test the integrity of endoscopic shield devices for endoscopes and other catheter devices. In some examples, these apparatuses may be configured to test a rigidizing shield for one or more leaks.

[0047] In general, an endoscopic shield device may be configured to cover external and internal surfaces of the endoscope to protect the endoscope from contamination. The leak testing apparatuses described herein may be configured for proximal attachment to the endoscopic shield to isolate an inner chamber of the endoscopic shield device. The assembly may then be pressurized with positive or negative pressure to test for leaks. In some cases the leak testing apparatus may include multiple one or more ports. In some cases the leak testing apparatus may be configured such that it is a flexible body that is squeezed to create the requisite test pressure, such that the captured volume, once compressed, is pressurized to test the device, such that no further source of pressure is needed, such that no port is necessary. Also describe described herein are leak testing apparatuses that do not include an inlet, but seal off the proximal end(s) of the shield and use one or more ports of the shield (e.g., the shield handle) to apply pressure (e.g., positive pressure, such as air) to test for leaks.

[0048] The inner chamber of the endoscopic shield device may have a tubular shape including an internal lumen that may receive a tubular shape of the endoscope body. For example, an endoscopic shield device may include an external shield that covers an external surface of the catheter and one or more internal shields that cover surfaces of one or more internal lumens of the catheter. The external shield may be rigidizing. See, e.g., U.S. patent no. 11937778, titled “APPARATUSES AND METHODS FOR DETERMINING IF AN ENDOSCOPE IS CONTAMINATED,” filed on May 30, 2023, and U.S. patent application no. 18 / 325,974, titled “ENDOSCOPE SHEATH APPARATUSES,” filed on 5 / 30 / 2023, each of which is herein incorporated by reference in its entirety. It may be difficult to detect leaks from a shield, and particularly a rigidizing shield, in which the proximal end may have a number of different ports, as well as protruding inner shields. The apparatuses and method described herein may allow for quick and effective techniques for detecting a leak which may be particularly useful in a clinical setting in which speed and accuracy are particularly important. Further, it is also important that leak testing be performed in a manner that prevents or reduces the possibility of cross-contamination, which is challenging with elongate, flexible devices.

[0049] Thus, the endoscopic shield device may define a tubular shaped cavity with one or more lumens.

[0050] Once the leak testing device is coupled with the endoscopic shield device, the internal chamber of the shield may be exposed to fluid (e.g., gas, air, CO2, liquid). Any leakage of the fluid from the internal chamber of the shield may then be detected. If leakage is not detected, the endoscopic shield device may be deemed to adequately protect the endoscope from contamination. If leakage is detected, the endoscopic shield device may have structurally failed or it may have included a defect that may have caused the endoscope to be exposed to contamination, thereby meaning that the endoscope would either need to be specially cleaned before further use, or disposed of.

[0051] The leakage testing may be performed after use and exposure to contamination (e.g. after a medical procedure) or may be performed prior to use. If performed after use, a positive leakage result indicates that the endoscope may have been contaminated and should be thoroughly cleaned before reuse (or disposed of); whereas a negative leakage result indicates that the endoscope was not contaminated and may be subject to less cleaning or no cleaning. If the performed before use, a positive leakage result indicates that the endoscopic shield device is defective and should not be used; whereas a negative leakage result indicates that the endoscopic shield device is intact and okay to use.

[0052] The apparatuses and methods described herein may be used to test leakage in endoscopic shield devices, shield assemblies and apparatuses, such as those described in PCT application PCTUS2023066293, filed April 27, 2023 and titled “HYGIENIC SHIELD FOR ENDOSCOPY,” which is incorporated herein by reference in its entirety.

[0053] The endoscopic shield devices described herein may be used with a single endoscope. An endoscope may refer to an elongate instrument which can be introduced into the body and may include one or more lumens extending therethrough and may be used for examining, treating and / or diagnosing an interior region of a body. Any of these endoscopes may include imaging (e.g., typically by a CCD, CMOS chip, or fiber optic material) to give a view from the distal end of the device. The endoscope may also be referred to as a catheter, and may include one (or more than one) internal lumen extending the length of the endoscope. For example, in FIG. 1A, the endoscope 100 includes an elongate flexible (or in some examples, selectively rigidizable) body that extends from a distal end 113 to a proximal end 111. The endoscope includes a first lumen 105 (e.g., a working channel) and a second lumen 107 and a camera 109. The first lumen may be a working channel through which one or more tools may be inserted or / or manipulated for acting on tissue at the distal end of the endoscope within the body. The second lumen may be, e.g., a suction, a fluid (air, water, etc.) application lumen, or the like. The lumen (e.g., the internal working channel) may extend the length of the endoscope. The endoscope may be any appropriate length and width and may generally be formed of abiocompatible material. FIG. IB shows a cross-section through the endoscope of FIG. 1A, and FIG. 1C shows a distal end view of the endoscope of FIG. 1 A.

[0054] FIGS. 2A-2C illustrate an example of an assembly 200 including an endoscope 201 that is coaxially arranged within a rigidizing shield (e.g., outer tube 203). The endoscope 201 (shown visible through the shield 203) may be similar or identical to the endoscope shown in FIG. 1A-1C, and may include one or more internal lumens 105, 107 (e.g., working channel 105) and may be configured to slide axially 220 within the shield 203. FIG. 2B show a section through the assembly of FIG. 2A and FIG. 2C shows a distal end view of the assembly of FIG. 2A and 2B along line C. In some examples the assembly may be a telescoping assembly including the endoscope 201 and the shield 203 configured to be flexible but may be selectively rigidized. The shield may include a distal cap 297 that is sealed to the outer shield body 213 of the shield 203 and to one or more inner shields 207, 205 that slide through and protect the inner lumen 105, 107 of the endoscope. The cap 297 at the distal end of the shield may include optics (e.g., lenses, etc.) and a deflector 292 for spraying fluid (e.g., water) to clear the lens through which a camera from the endoscope may image. An endoscope or endoscope assembly such as those shown schematically in FIGS. 1A-1C and 2A-2C may be used with any of the endoscope endoscopic shield devices (e.g., shield assemblies) described herein. FIGS. 2D1-2D2 shows a section (D) through a portion of a shield such as the one shown in FIGS. 2A-2C, and a portion of the endoscope, illustrating the rigidizing outer shield 203 of FIGS. 2A-2C, including the layers forming the rigidizing shield. Note that in some examples the shield is not rigidizing and may not include all of the layers shown. The shield may also include a coating, for example a hydrophilic coating, which could be positioned radially outward of layer 203.

[0055] For example, in FIG. 2D1 the shield 203 is shown in a flexible state (non-rigidized), and includes an outer support layer 211, which may be reinforced, e.g., by a coil 213 or other materials. The outer support layer may generally resist radial expansion, but may be flexible along its length. For example, the outer support layer may be a flexible polymeric material (within which one or more supporting elements, e.g., a fiber or a wire, such as a helically wound flat wire 213) may be embedded. The rigidizing shield in this example also includes a rigidizing layer 215, formed of plurality of lengths of filaments that may cross each other, and in the flexible configuration(s) may slide over each other relatively feely. In sone examples all or some of the rigidizing layer may be formed of axial lengths (“axials”) that extend in the long axis of the shield. In some cases all or some of the rigidizing layer may be formed of a knit, woven and / or braided material. In some cases the plurality of lengths of filaments forming the rigidizing layer may be formed of a single filament (e.g.,. a woven, tubular layer) or a plurality of filaments. The rigidizing layer may reside in a space or gap region 219 between the outer supportlayer 211 and a bladder layer 217. The bladder layer may form a single (as in FIGS. 2D1 and 2D2) or a double layered (as in FIGS. 2D3-2D4) forming a radially inwards surface that may be driven, by positive and / or negative pressure, against or away from the rigidizing layer. All of these layers may be formed as tubular layers, which together form the sleeve. In FIG. 2D1, the bladder layer is separated from the outer surface of the endoscope 101 which is within the lumen 220 of the shield so that a space or gap is present.

[0056] FIG. 2D1 shows the rigidizing shield in an un-rigidized, e.g., flexible, state. In this configuration the bladder layer 217 is separated from outer layer 211 and the rigidizing layer 215 is within the gap region 219 so that the lengths of filament (and / or axial lengths) forming the rigidizing layer 215 are free to slide over each other. In some cases this separation between the bladder layer 217 and the support layer 211 may be maintained by a positive pressure within the gap 219 and / or negative pressure within the lumen 220 of the shield. Alternatively, the pressure within the lumen 220 may be open to atmosphere and / or the gap 219 may be vented to atmosphere (typically at a proximal handle region). FIG. 2D2 shows the shield apparatus in a rigid configuration, in which the bladder layer 217 is driven against the rigidizing layer 215, compressing the lengths of filament of the rigidizing layer against each other and against the outer support layer 211, as shown. Since the lengths of filament are locked in position, in some cases against each other and / or against and between the outer layer 211 and the bladder layer 217, the shield is rigid; for example, the pressure of the bladder layer against the lengths of filament may control the rigidity by increasing or decreasing this compression and the shield is prevented from bending, e.g., made rigid. This may be accomplished by the application of positive and / or negative pressure. For example, the bladder layer may be driven against the rigidizing layer by applying positive pressure within the lumen 220 of the shield, and / or may be driven against the rigidizing layer by applying a negative pressure within the gap between the outer support layer 211 and the bladder layer 217, and / or may apply positive pressure between the layers forming the bladder layer 217 (which may be, for example, a tubular layer that inverts over itself to form a double layered bladder tube). In some cases both positive and negative pressure may be applied; alternatively just positive pressure may be applied. Positive pressure may be applied by applying a fluid (e.g., air, saline, etc.) and / or negative pressure may be applied by removing the fluid. In some cases air is used to apply positive pressure.

[0057] FIGS. 2D3 and 2D4 illustrate a similar example in which the bladder layer is an out- and-back bladder layer 217’. In this example, pressure (e.g., positive and / or negative pressure may also or alternatively be applied between within the bladder layer 217. For example, in FIG. 2D3, the rigidizing shield is shown in a flexible state and the rigidizing layer (e.g., the lengths of filament, axials, etc.) are free to move, allowing bending. The bladder layer may be kept awayfrom the rigidizing layer by one or more of applying negative pressure within the bladder layer (e.g., collapsing the two, out-and-back sheets of the bladder layer collapsed) and / or negative pressure may be applied in the lumen 220 of the shield, and / or positive pressure may be applied in the gap region 219 between the outer support layer 211 and the bladder layer. FIG. 2D4 shows the same shield region rigidized by expanding the layers (e.g., the out-and-back sheets) of the bladder layer to drive the radially outward sheet / layer 217” against the rigidizing layer, and the radially inward sheet / layer 217”’ against the endoscope 101, inflating the region 277 within the bladder layer.

[0058] FIGS. 3A-3C illustrate examples of endoscope shields and endoscopic shield devices, which collectively shield an endoscope from contamination during use when the endoscope is inserted within the human body. The shields illustrated in FIGS. 3A-3C are shown unattached or unconnected to either an endoscope or an endoscope assembly (e.g., an outer tube and an inner endoscope member). The endoscopic shield devices of FIGS. 3A-3C each define a tubular cavity that is shaped to accept a tubular shape of the endoscope. In FIG. 3A for example the endoscope assembly 300 includes a distal cap 327 that is configured to secure to and over a distal end region of an endoscope. For example, the distal cap 327 may snap onto the distal end, e.g., the distal cap may connect to the distal end of the catheter by a deflectable snap on either the distal cap, the distal end of the endoscope, or both. For example, the distal cap may include a bendable or flexing member to releasably lock (e.g., by a “snap fit”) the distal cap onto the distal end of the endoscope. In some examples the distal cap may secure (releasably secure) to a distal end of an endoscope by a clamping or spring-loaded mechanism. In some examples the distal cap may couple by engaging a screw-on or threaded region. In some examples the distal cap 327 may couple by a friction fit (e.g., the distal cap may include one or more shear surfaces that are configured to secure the distal cap to the distal end of the endoscope). In some examples the distal cap may couple magnetically to the distal end region of the scope to secure the distal cap to the distal end. In some examples the distal cap may be secured to the distal end of the scope by a bayonet connector or a shear pin.

[0059] In FIG. 3 A an external shield 302 is shown sealing connected (e.g., fused, welded, integrally formed, etc.) to the distal cap 327. The external shield may be flexible and in particular may be sufficiently thin or thin- walled that it may be lightweight and may move relative to the outer tube (not shown) as the endoscope moves in and out of the outer tube and / or rotates relative to the outer tube. The example shown in FIG. 3 A includes a single internal shield 315 extending proximally within the external shield, and sealing connected to the distal cap 327. The sealing connection between the distal cap 327 and the internal shield 315 is such that the internal lumen of the internal shield 315 is open to the body so that fluids may be applied through theendoscope without compromising the endoscopic shield between the patient and the endoscope. In FIGS. 3A-3C the internal shield forms only a single lumen as shown in this example, in other examples multiple lumen structures may be used, such multi-lumen catheters. Thus, as shown in FIG. 3 A the internal shield may form an opening 315’ through the distal cap that is continuous with the internal shield 315 shown.

[0060] In this example the external shield 302 is shorter than the internal shield 315, and the internal shield 315 extends proximally 331 from out of the external shield. In some examples, a short external shield may be coupled to an outer tube (not shown in FIG. 3A) such as an overtube, and may be sealed to the outside so that the outer tube may act with the external shield to protect the endoscope extending within the outer tube.

[0061] FIG. 3B illustrates another example of an endoscope shield device 300’ (e.g., endoscopic shield device) similar to that shown in FIG. 3A, but with a second internal shield 317, having a distal opening 317’ through the distal cap 327 that may pass material or tools into and out of the endoscope to treat tissue. Thus, the endoscope endoscopic shield device 300’ defines a tubular cavity that includes two lumens (formed by the first and second internal shields 315, 317). In FIG. 3B the second internal shield 317 may form a working channel liner that may line the working channel of the endoscope. The internal shields may be catheters, including multi-lumen catheters. The external shield 315 in FIG. 3B may be similar to that shown in FIG. 3A and may be relatively short, e.g., may couple to an outer tube (not shown). In any of these endoscopic shield devices described herein the external shield may include a proximal attachment on the external shield configured to secure the external shield to an outer surface of an outer tube that is coaxially arranged over the endoscope.

[0062] FIG. 3C shows a endoscopic shield device 300” similar to that shown in FIG. 3B, including a first internal shield 315 that opens 315’ through the distal cap 327 and a second internal shield 317 (e.g., working channel liner) that also opens 317’ through the distal cap 327, both sealingly attached to the distal cap, and an external shield 302’ that is elongate and sealingly coupled to the distal cap at a distal end and may optionally include a proximal attachment region or proximal attachment 321 for attaching to either the endoscope or an outer tube that is configured to coaxially fit over the endoscope.

[0063] The endoscopic shield devices may comprise a flexible, thin material. In some cases, the shields are made of a resilient material. The internal shields may be made of the same material as the external shield or be made of a different material than the external shield. The external shield and / or internal shield may be comprised of one or more materials, including plastics, elastomers, plastomers, or composite materials. The shield may be formed of a single material having different regions (e.g., thin-walled region and thicker-walled or ruggedizedregion) or a shield may be formed of different materials that are coupled (e.g., fused, sealed, etc.) together.

[0064] As mentioned, the endoscopic shield device may be configured as rigidizing shields. The shields may be referred to as field- installable shields, as they may be quickly and easily inserted over an endoscope to convert the endoscope into a rigidizing endoscope, which may be converted between flexible and rigid configurations by the application of pressure. The rigidizing shield may convert a flexible endoscope into a rigidizing endoscope by coupling the rigidizing shield over (and in some cases into) the endoscope. The endoscope may then be selectively rigidized, e.g., converted between highly flexible and less flexible (e.g., rigid) states by the application of pressure (e.g., positive and / or negative pressure). In examples the converted “rigidizing endoscope” may be used with a second rigidizing member, e.g., a rigidizing overtube. The examples of rigidizing apparatuses described herein may use pressure (positive pressure and / or negative pressure) to selectively and controllable rigidize.

[0065] For example, FIGS. 3D-3G illustrate a system including an endoscope 350, having one or more lumens (e.g., in this example, a first lumen 351 and a second lumen 355), and a rigidizing endoscope endoscopic shield device 385. The rigidizing endoscope shield device 385 includes a distal cap 377 that is configured to attach to the distal end region of the endoscope 350 and includes one or more internal shields (in this example, a first internal shield 365 and a second internal shield 367) that are configured to fit within the endoscope 350. The rigidizing endoscope shield device 385 also includes a rigidizable external shield 352. The rigidizable external shield 352 is a tubular shield that is sealed to the distal cap 377. The external shield 352 may have an inner diameter that is slightly greater than the outer diameter of the inner endoscope 350. The rigidizable external shield 352 may include a rigidizing layer or region that engages with a compression layer (which may be or may include a bladder) that applies force to the rigidizing layer to rigidize the rigidizing layer or in some cases, to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizable external shields 352 may include a rigidizing layer that could include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, crossing filaments, or other materials forming the rigidizing layer. For example, the rigidizing layer may comprise multiple strand lengths or strand segments that cross over each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply force to drive the crossing strand lengths or strand segments against each other. In some examples the rigidizing layer may be a braided layer, however any of these apparatuses may instead or in addition include a general rigidizing layer comprising crossing strand lengths or strand segments. The examples of rigidizing apparatuses described herein may use pressure (positive pressure)and / or negative pressure to selectively and controllable rigidize. In some examples the method described herein may be used with any appropriate rigidizing apparatus.

[0066] FIG. 3F shows an example of the assembled inner catheter 350 and the rigidizing endoscope shield device 385. The inner rigidizing shields are inserted into the lumen of the endoscope, the distal cap is coupled to the distal end of the endoscope, and the outer rigidizing endoscope shield 352 extends over the outer surface of the endoscope.

[0067] Any of these systems may also optionally include a second, outer, endoscope 389, as shown in FIG. 3G. Thus, these apparatuses may be used in a nested configuration. The outer endoscope may also be rigidizing in some configurations. As mentioned, the outer endoscope 389 (e.g., overtube) may be one-time / disposable, and / or may be reusable (e.g., by cleaning or by shielding). Similarly, the endoscope shield device may be single use / disposable or may be reusable (e.g., by cleaning). The endoscope may be reusable, and may include, e.g., a camera, illumination, pull cables, coil pipe assembly, bending section, etc. The inner endoscope may be inserted into a fresh endoscope shield device and secured in place for a procedure, and then unsecured and removed after a procedure.

[0068] In any of the endoscopic shield device examples, the distal cap may be clear (transparent) to allow imaging through or may include a window region configured to align with a camera region of an endoscope. In some examples, the distal cap has an anti-reflective or antiglare coating.

[0069] The endoscopic shield devices described herein may include any number of internal shields (e.g., 1, 2, 3, 4, 5, 6 or more). The endoscopic shield devices described herein may include any number of internal lumens (e.g., 1, 2, 3, 4, 5, 6 or more).

[0070] Described herein are methods and apparatuses that are configured to test the endoscopic shield devices, such as those shown in FIGS. 3A-3G, for leakage. The testing may occur, for example, before or after using the endoscopic shield device to cover an endoscope (or endoscope assembly) during a medical procedure and where the outer surface of the endoscopic shield device has been exposed to contaminants. If used after exposure to contaminants during a medical procedure, the testing may be used to confirm that the shield has remained leak-free, and that the underlying endoscope therefore remains clean. If used before exposure to contaminants, the testing may be used to confirm that the shield is defect free and useable for protecting the endoscope.

[0071] FIGS. 4A and 4B show an example of an endoscopic shield device 400 configured as a rigidizing endoscopic shield device. In this example, the endoscopic shield device 400 includes an external shield 401, a first internal shield 403, a second internal shield 405 and a port adapter 409. The external shield 401 may be configured to transition between relatively rigid and flexiblestates, as described herein. The external shield 401, the first internal shield 403, and the second internal shield 405 are coupled together at a distal end by a distal cap 407. The shields 401, 403, 405 may be sealed with (e.g., fused, welded, integrally formed, bonded, etc.) to the distal cap 407, as discussed above, to provide a contamination endoscopic shield to an endoscope (or endoscope assembly) that the endoscopic shield device 400 is configured to cover.

[0072] The port adapter 409 (also referred to as a manifold) is coupled with a proximal region of the shields 401, 403, 405. In this example, the port adapter 409 includes a first port 411 and a second port 413 that provide fluid access into and / or out of a tubular shaped cavity formed by the endoscopic shield device and / or between one or more layers of the external shield 401. These ports may be positioned in the general proximal region, but do not necessarily need to be located in the most proximal port of the device. For example, positive and / or negative pressure may be supplied within one or both of the first and second ports 411, 413 to activate the rigidization of the endoscopic shield device 400.

[0073] The port adapter 409 is configured to mate with a leak testing device 500 shown in FIGS. 5A-5D. In this example, a proximal end of the port adapter 409 has a locking feature 415 that is configured to engage with a corresponding locking feature of the device 500. In this example, the locking feature 415 includes slots that are configured to accept corresponding protruding features of the device to reversibly lock the device 500 to the port adapter 409. This configuration may be referred to as a bayonet fitting. In this case, the slots are configured to lock the device 500 to the port adapter 409 upon relative rotation of the device 500 and the port adapter 409. For example, a portion of the slot run circumferentially partially around the port adapter 409 to capture a protrusion of the device 500 within the slot upon relative rotation.

[0074] As mentioned, in use, the shield, including a rigidizing shield as described above, may be inserted both over and into an endoscope to protect it from contaminants and to form a rigidizing endoscope. Once it has been used, e.g., as part of a procedure within a body, such as part of a colonoscopy procedure, the assembly may be removed and the shield may be taken off; if the shield has remained intact, the endoscope covered by the shield may remain relatively clean, and may be prepared for further use, including inserting into another shield, for use in the same or a different patient. As part of the removal process the inner shield(s), e.g., first and second internal shields 403, 405, may be sealed before removing from the scope to prevent contamination of the scope. In some cases these internal shields may be crimped, as shown in FIGS. 4C and 4D. FIG. 4C shows the first internal shield 403, configured as a multi-lumen catheter, and a scone internal shield 405, having a somewhat larger diameter, in the unclosed configuration. The internal shields may be heat sealed. The internal shields may be RF sealed, the internal shields may be plugged. It may be adhesively blocked. Before removing the shieldfrom the endoscope both of these internal shields may be closed (e.g., crimped) as shown in FIG. 4D. In this example, the first 403’ and second 405’ inner shields are sealed closed by applying heat and crimping them so that the ends 463, 465 are sealed shut. Once the ends of the internal shields are sealed, the endoscope may be removed from the shield, including sliding the internal shields through the lumen (e.g., working channel(s)) of the endoscope without contaminating the endoscope. The proximal end, including the sealed ends, of the shieled, both the outer shield and the inner shield(s), may be coupled to a leak testing apparatus (e.g., testing device), as described in greater detail below.

[0075] FIGS. 5A-5D show the leak testing device 500 that is configured for removable attachment with the endoscopic shield device 400 for leak testing. FIGS. 5A and 5B show the device 500 itself, uncoupled from the endoscopic shield device 400. The device 500 includes a body 501 that includes an interface for coupling with the endoscopic shield device 400. For example, the body 501 includes an outer interface portion 505 that is configured to interface with an exterior surface of a proximal end of the port adapter 409, and inner interface portion 507 that is configured to interface within an interior surface of the proximal end of the port adapter 409 (e.g., the lumen of the port adapter 409). In this example, outer interface portion 505 and the inner interface portion 507 each have a ring shape (e.g., corresponding to the ring-shaped interface regions of the port adapter 409) and that are coaxially arranged. In this example, the inner interface portion 507 protrudes distally with respect to the outer interface portion 505, which may help to provide mating engagement with the port adapter 409.

[0076] The body 501 includes a channel 508 that provides access to a chamber (shown in FIGS. 6B-6D) within the body 501. The chamber is shaped (e.g., large enough) to accept the proximal ends of the first and second internal shields 403, 405. The chamber is configured to enclose proximal ends of the first and second inner shields 403, 405.

[0077] The body 501 may include one or more seals to seal the body 501 with the endoscopic shield device 400 and fluidically isolate the tubular cavity of the endoscopic shield device. In this example, the outer interface portion 505 includes a first seal 509 that provides a seal between the outer interface portion 505 and the port adapter 409, and the inner interface portion 507 includes a second seal 511 that provides a seal between the inner interface portion 507 and the port adapter 409. In this example, the first and second seals 509, 511 are annular seals (e.g., O-rings). Although in this example two seals 509, 511, the body 501 may include any number of seals (e.g., 1, 2, 3, 4 or more seals).

[0078] The leak testing apparatus (device 500) in this example includes a pressure port 503, which provides access to chamber of the body 501, and to the tubular shaped lumen of the endoscopic shield device 400 when coupled with the device 500. Thus, when the device 500 iscoupled with the port adapter 409, as shown in FIGS. 5C and 5D, the tubular shaped lumen of the endoscopic shield device 400 (in which the endoscope was, or will be, positioned in) can be closed but accessible via the pressure port 503. The pressure port 503 may be configured to couple with a positive or negative pressure line, which is operationally coupled with a positive pressure or negative pressure (e.g., vacuum) source. The assembly including the shield and the leak testing apparatus, may be processed to detect a leak from the shield, for example by inserting the assembly into a liquid bath (to identify bubbles) and / or coating it with a material that will form bubbles when a leak is present. For positive pressure, the presence of released bubbles (or pressure leak down) would be an indicator of failure. For negative pressure, a change in pressure (or ingress into 501) would be an indicator of failure. In some cases, the pressure port 503 includes a valve that is configured to open and close.

[0079] The device 500 includes a lock that is configured to lock the device 500 with the endoscopic shield device 400. For example, an inner surface of the outer interface portion 505 includes locking features 513 that are configured to slide within the corresponding features 415 (slots) of the port adapter 409. As described, the locking features of the device 500 and the port adapter 409 are configured to sealingly lock together when the device 500 is rotated with respect to the port adapter 409 (once the locking feature 513 (protrusion) has been slid within the locking feature 415 (slot)).

[0080] FIG. 6A shows a cross-section view of the endoscopic shield device 400, including the port adapter 409. This cross-section view shows the tubular shaped lumen 602 formed by the endoscopic shield device 400, including the external shield 401, the internal shield 403 and the distal cap 407. The tubular shaped lumen 602 is where the endoscope (or endoscope assembly) is placed within to shield the endoscope (or endoscope assembly) from contamination during a medical procedure.

[0081] FIG. 6B shows a cross-section view of the device 500 coupled with the endoscopic shield device 400. The first seal 509 and the second seal 511 provide an airtight seal between the device 500 and the port adapter 409. FIGS. 6C and 6D show partially transparent views of the device 500 coupled with the endoscopic shield device 400. The distal openings of the inner shields 403, 405 can be sealed, e.g., by crimping, plugging, adhesively bonding, welding (e.g., heat or RF) or melting, to seal off their inner lumens before positioning with the chamber 604 of the body 501.

[0082] Once the device 500 is coupled with the port adapter 409, suction, pressurized gas (‘insufflation’) or fluid (e.g., saline) may be supplied within the tubular shaped lumen 602 via the pressure port 503 to test the integrity of the endoscopic shield device 400. For example, pressurized air may be supplied via the pressure port 503 to test whether the endoscopic shielddevice 400 has any leakage defects by the leakage of air. Air leakage may be detected, for example, by placing the port adapter 409 and the device 500, while pressurized with air, within a container of fluid (e.g., water) so that any leaks will be apparent by the formation of bubbles in the fluid. In addition, the test can be used to identify where in any leakage defects are located within the endoscopic shield device 400. In any of these examples the shield (or the assembly of the shield and leak tester) may be weighed down so that it is under water, or to contain it within a net, cage, etc. so that it remains immersed.

[0083] In some cases, the pressure (e.g., air pressure) within the tubular shaped cavity 602 is monitored, for example, using a pressure sensor. The pressure sensor may be coupled to the pressure port 503. The pressure sensor may track a pressure decay curve that may be reported and / or analyzed to determine if there is a leak, suggesting contamination. The pressure data may be reported to the operator and / or an apparatus (e.g., computer) may automatically or semi- automatically determine if there is a leak based on the pressure data. For example, the apparatus may include software, hardware and / or firmware to receive pressure data configured to analyze the pressure data (e.g., decay curve), compare the pressure response to predetermined values to determine if there is a leak.

[0084] The leakage test procedure may be performed at any time. For example, the test may be performed prior to or after a medical procedure. If the leak test is performed after the endoscopic shield device 400 was used in the medical procedure and the endoscopic shield device 400 is found not to have a leak, the endoscope (or endoscope assembly) can be determined to be properly shielded by the endoscopic shield device. On the other hand, if the endoscopic shield device 400 is found to have leak, the endoscope (or endoscope assembly) may have been exposed to contamination during the medical procedure and should be more rigorously cleaned prior to reuse (or portions of the endoscope assembly could be discarded). If the leak test is performed prior to the medical procedure and the endoscopic shield device 400 was not found to have a leak, the endoscopic shield device 400 may be deemed acceptable to use. If the leak test is performed prior to the medical procedure and the endoscopic shield device 400 was found to have a leak, the endoscopic shield device 400 may be discarded in favor of a different endoscopic shield device.

[0085] Although in the example endoscopic shield device 400 shown in FIGS. 4A-6D includes two internal shields 403 and 405 and two corresponding lumens, the device 500 may be configured to test an endoscopic shield device having any number of internal shields and lumens (e.g., 1, 2, 3, 4, 5, or more). For example, the chamber 604 of the body 501 may be configured to accommodate any number of internal shields. FIG. 6D also schematically illustrates an example of an apparatus (e.g., leak testing apparatus) that is configured to include a seal for sealing off arigidizing port (e.g., rigidizing port seal 638) on an endoscope shield. The rigidizing port seal may be coupled to (or integrated with) the leak testing apparatus, including the body portion of the leak testing apparatus, or it may be a separate component. In the example shown schematically in FIG. 6D the rigidizing port seal 638 is tethered to the body of the leak testing apparatus by a tether 670.

[0086] FIG. 7 is a flowchart indicating an example method for leak testing an endoscopic shield device for an endoscope. In this example, the endoscopic shield device includes an external shield and at least one internal shield that define a tubular cavity that is shaped to accept a tubular shape of the endoscope. The external shield and / or internal shield(s) may be configured as rigidizable shield(s). As such, the external shield and / or internal shield(s) may include multiple layers (e.g., rigidizing layer, compression layer, bladder), as described herein.

[0087] At 701, the endoscopic shield device is optionally removed from an endoscope, for example, after a medical procedure where the covered endoscope was exposed to contaminants. Thus, the leak testing procedure is performed after the endoscopic shield device has been already used. In other cases, the leak testing procedure is performed prior to exposure to contaminants (i.e., prior to the medical procedure).

[0088] As mentioned, the proximal opening(s) of the internal shield(s) of the endoscope endoscopic shield device is / are sealed 703. Sealing the proximal openings may include fusing (e.g., heat sealing, heat welding, RF welding, plugging, adhesively bonding, ultrasonic welding, etc.), crimping and / or adhesively bonding the proximal end(s) of the internal shield(s). In some cases, sealing may include placing stopper(s) within the proximal opening(s) of the internal shield(s).

[0089] Once the internal shield(s) is / are sealed, at 705 a leak testing device is coupled to a proximal end region of the endoscopic shield device. The device may include a chamber that is configured to enclose the sealed proximal end(s) of the internal shield(s) of the endoscopic shield device. The device may also include an interface that is configured to interface and engage with a proximal end of the endoscopic shield device. For example, the interface may be configured to interface and engage with a port adapter coupled with the external and internal shields of the endoscopic shield device. The interface may include one or more seals (e.g. O-rings, elastomeric seals, etc.) to create a fluid-tight (e.g., airtight) seal with the endoscopic shield device (e.g., port adapter of the endoscopic shield device). In some cases, the device may include a lock that is configured to lock the device to the proximal end region of the endoscopic shield device in a sealed state.

[0090] Once the leak testing device is coupled to and sealed with the proximal end region of the endoscopic shield device, at 707 an internal cavity of the endoscopic shield device ispressurized. The internal cavity of the endoscopic shield device may include the tubular cavity for housing the tubular shaped endoscope therein. There may be an external pressure source that is a machine, such as those commercially available from Uson. The pressure source may be a syringe, with a known volume that corresponds to a known pressurization value when fully actuated. The pressures source may be a syringe coupled to a pressure gage. If the external shield and / or the at least one internal shield of the endoscopic shield device includes multiple layers (e.g., configured for pressure rigidization), the internal cavity may also include regions between the multiple layers. Thus, the pressure testing may test the integrity of the external shield and the one or more internal shields; and the testing may also test the integrity of the multiple layers within the external shield and / or one or more internal shields. Pressurizing the internal cavity may involve applying pressure (positive or negative) within the chamber of the device via a pressure port of the leak testing device, which is then distributed throughout the internal cavity of the endoscopic shield device. In some cases, during testing where a positive pressure is applied, the positive pressure may range between about 50 mmHg and 500 mmHg (e.g., between about 100-400 mmHg, between about 100-300 mmHg, between about 140-250 mm Hg, between about 50-250 mmHg, etc.). In cases where a negative pressure (vacuum) is applied. In some cases, negative pressure may be applied between about full vacuum and a tenth vacuum (e.g., between full vacuum and half vacuum, between quarter vacuum and full vacuum, etc.).

[0091] Note that although these methods and apparatuses are configured for testing a shield for leaks after use, in some cases the apparatus may be configured test for leaking before use. For example, the leak testing apparatus may either receive the temporarily sealed inner shield(s) within the body, or may pass the inner shield(s) out of the body and seal around them. In any of these methods and apparatuses the inner shield(s) may be temporarily plugged, e.g., by the use of a plug (e.g., silicone plug, etc.) or by adhesive or by heat or RF or force-sealing (e.g., crimping) for testing, then removing the seal (e.g., cutting the sealed region) before use.

[0092] In general, as part of a post-cleaning, “ready-for-use” determination testing, endoscopes may be pressure tested from within, within a testing range (e.g., within the ranges of about 200 mmHg, and examined to determine a loss of pressure and / or formation of bubbles within a water bath; should bubbles emanate from the endoscope during this testing, the tester knows that the endoscope is no longer sealed and has the potential to be contaminated, such that the endoscope needs to be repaired or disposed-of.

[0093] In the apparatuses and methods described herein the shield apparatus may instead be tested by providing pressure, in some cases through the leak testing apparatus, as described herein, and examining for loss or pressure and / or bubbles of the shield apparatus. The testingpressure applied (e.g., between 50-500 mmHg) may be applied via a syringe (E.g., a 60 cc syringe) or a pressure applicator that may include a pressure gauge. In some cases, using a syringe may include the use without requiring a pressure sensors, and may be used by pushing a syringe coupled to the leak testing apparatus to develop the pressure within the assembly of the leak testing apparatus and the lumen of the shield assembly. Either the leak testing apparatus or the syringe may include a valve (e.g., stopcock, etc.) or a one-way vale in line with the port connected to the syringe to maintain the pressure inserted into the assembly from the syringe. In some cases, e.g., in a leak testing apparatus such as shown in FIGS. 6A-6D, the body region 604 may include or may be configured as an adapter between the port 409 and a pressure syringe source. In some cases the pressure-applying source (e.g., syringe, pump, etc.) may be coupled to the body at a port 503. As mentioned above, in some cases the leak testing apparatus may not include a port and instead the pressure may be applied through one or of the proximal ports on the rigidizing shield (e.g., first or second ports 411, 413). Thus, in some cases test pressure may be applied by coupling a syringe to the first or second ports. The leak tester may therefore not necessarily include a separate port.

[0094] At 709, any leakage from the cover may be detected from the pressurized cover. One way of detecting leakage is by using a positive gas (e.g., air) pressure and placing the endoscopic shield device, with the leak testing device attached, within a container of liquid (e.g., water). Alternatively, a leak detector liquid may be applied to the endoscopic shield device. Any leakage defects may become evident by the presence of bubbles. An advantage of using this method is that the site of any leakage defect in the cover may be easily identified based on the location of the emanating bubbles. Alternatively or additionally, the pressure may be monitored, for example, using a pressure gauge (e.g., coupled to the pressure port of the leak testing device). If the pressure decays over a period of time, the cover can be determined to have a leakage defect. Any pressure changes may be detected whether using positive or negative (vacuum) pressure.

[0095] If the leak testing procedure was performed after the endoscopic shield device was exposed to contaminants (e.g., after the covered endoscope was used in a medical procedure) and results of the test indicate that the endoscopic shield device has a leak, this indicates that endoscope may be contaminated and therefore needs thorough cleaning. If results of the test indicate that the endoscopic shield device does not have a leak, this indicates that endoscope was not contaminated and therefore does not need cleaning or at less thorough cleaning.

[0096] If the leak testing procedure was performed prior to the endoscopic shield device being exposed to contaminants (e.g., before using the covered endoscope in a medical procedure) and results of the test indicate that the endoscopic shield device has a leak, this indicates that the endoscopic shield device is defective and should not be used. If results of the test indicate thatthe endoscopic shield device does not have a leak, this indicates that endoscopic shield device is intact and can be used as a contamination endoscopic shield for an endoscope. For example, the sealed proximal end(s) of the internal shield(s) may be opened so that the internal shield(s) are operational.

[0097] FIGS. 8 and 9 illustrate alternative examples of leak testing apparatuses. In any of these apparatuses the leak testing apparatus may be injection molded. In general, as shown in FIG. 8, the body region may be configured to have a minimal internal volume, and the draft of the internal volume may be narrow. Thus, in any of these apparatuses the pressurization may be relatively minimal (e.g., 40 cc or less, 35 cc or less, 30 cc or less, 25 cc or less, 20 cc or less 15 cc or less, 10 cc or less, 8 cc or less, 7 cc or less, 5 cc or less, etc.). This may make it easier to apply test pressure (e.g., from a syringe) and may reduce the wall stress. In general the leak testing apparatus may be molded.

[0098] FIG. 8 shows a cross-section through one example of a leak testing apparatus including (leak testing device 800) coupled to a rigidizing shield, including an outer shield and one or more inner shields. In FIG. 8 a single inner shield 403 is visible, including crimped proximal end 863, within a body chamber 804 of the apparatus. The first leak test apparatus includes a seal 809 (and may also include a second seal, as described above) to provide an airtight seal between the leak test apparatus 800 and a port adapter 409 of a shield. In FIG. 8 the leak test apparatus 800 coupled with the endoscopic shield device 400. The distal openings of the inner shield(s) are shown sealed, e.g., by crimping, welding (e.g., heat or RF) or melting, to seal off their inner lumen(s) before positioning with the chamber 804 of the body 801.

[0099] In FIG. 8 the variation shown has a very low internal volume (e.g., less than 20 cc) when the shield is coupled. As mentioned, this may help facilitate testing. Once the leak test apparatus 800 is coupled with the port adapter 409, suction, pressurized gas (‘insufflation’) or liquid (e.g., saline) may be supplied within the tubular shaped lumen 802 via the pressure port 503 (and / or via a port on the shield) to test the integrity of the endoscopic shield device 400. For example, pressurized air may be supplied via the pressure port 503 to test whether the endoscopic shield device 400 has any leakage defects by the leakage of air. Air leakage may be detected, for example, by holding the port adapter 409 and the device 500, while pressurized with air, within a container of fluid (e.g., water) so that any leaks will be apparent by the formation of bubbles in the fluid. In addition, the test can be used to identify where in any leakage defects are located within the endoscopic shield device 400. As mentioned, the shield (or the assembly of the shield and leak tester) may be weighed down so that it is under water, or to contain it within a net, cage, etc. so that it remains immersed.

[0100] In FIG. 8 (and corresponding FIGS. 10A-10C), the handle of the leak test apparatus including a base handle region (e.g., body) that may be molded and includes a luer connection for coupling to a pressure source. The apparatus may include a valve (e.g., stopcock, one-way valve, etc.). The pressure source may be a syringe (E.g., 60 cc syringe, 30 cc syringe, 10 cc syringe, etc.). In some cases the leak test apparatus is configured to couple to the proximal end of the shield, e.g., by including alA twist lock securing the leak test apparatus to the shield (e.g., a proximal adapter). Once connected, the leak testing assembly including the rigidizing shield may be pressurized. For example, FIGS. 10A-10C illustrate coupling of the shield 400 with the leak test apparatus 800. In FIG. 10A the leak test apparatus 800 receives the inner shield(s) 403, 405 within the inner chamber by coupling the leak test apparatus to the proximal end of the shield (see arrow 1001). In FIG. 10B the leak test apparatus may be secured to the shield assembly by rotating it (e.g., one quarter turn 1003) to engage a releasable lock (e.g., in FIGS. 10A-10C a pin on the shield engages a locking channel on the leak test apparatus). FIG. 10C shows the two engaged with each other.

[0101] FIG. 9 shows another example of a leak test apparatus 900. In this example a separate source of pressure is not needed to test for leaks once coupled to a shield 400. Instead, the body of the leak test apparatus include a squeeze blub region 944 and an inlet control 946 (e.g., exhaust button) with internal check valves, shown in FIGS. 11A-11C. that may be used to apply pressure into the lumen of the shield 400. As shown in FIG. 11A-11C, the leak test apparatus 900 includes a squeeze bulb 944 and is configured to sealing couple to the shield as described in the examples above. The squeeze bulb may be formed as an elastomeric material (e.g., polymer) that may be squeezed to apply pressure and upon release may have a restoring force to resume the uncompressed configuration. The squeeze bulb may be sized so that its squeeze-actuation creates the requisite required test pressure. The squeeze bulb may be connected to an internal chamber 904 that may receive the inner shield(s) and may be fluidly connected to the lumen of the shield (e.g., the lumen of the outer shield that receives the endoscope). The inner chamber of the squeeze bulb may be coupled to this inner chamber by a one-way valve, e.g., a check valve, that allows the flow of pressurized air (or other fluid) from the squeeze bulb into the chamber 904, but prevents return flow. In some cases more than one valve may be used.

[0102] The squeeze bulb is also connected to a pair of check valves 948, 949. The first of these check valves 948, which is coupled to the region between an inlet and the squeeze bulb, may be configured to allow flow of air (or other fluid) into the squeeze bulb, but not out of the squeeze bulb. However, the second check valve, which may be released by the inlet control (release button 946), which may prevent the passage of air into the bulb (or into the inlet into the bulb) unless the control is activated, disabling the second valve 949.

[0103] FIGS. 1 IB-11C illustrate operation of this variation of a leak test apparatus to test for leaks in a shield that is coupled to the leak test apparatus. For example, in FIG. 1 IB the bulb 944 may be manually squeezed, driving pressurized air from the squeeze bulb through the into the chamber 904 and into the check valve 950 between the squeeze bulb and the chamber, pressuring the shield. Additional air may be allowed from outside of the squeeze bulb by pushing the release button 946 to disengage the rear check valve 949, and allow flow through the second check valve 948, as shown in FIG. 11C, resorting the squeeze bulb to the original configuration so that it may be squeezed again (after disengaging the release button 946) to apply additional positive air pressure within the shield. The leak test apparatus may be manually operated with a single hand.

[0104] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0105] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0106] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0107] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singularforms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0108] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0109] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0110] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0111] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0112] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0113] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0114] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Suchembodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. An apparatus for determining whether an endoscope shield has a leak, the apparatus comprising: a body configured to sealingly couple to the endoscope shield, wherein the endoscope shield includes an external shield and at least one internal shield extending through a lumen of the external shield; a chamber within the body that is configured to receive at least a portion of the at least one internal shield; and a pressure port that is configured to provide fluid access to the chamber, such that pressure can be applied to assess potential leakage through the endoscope shield.

2. The apparatus of claim 1, wherein the body is configured couple to a handle at a proximal end of the endoscope shield.

3. The apparatus of claim 1, wherein the body is configured to receive internal shield member(s) that have been sealed at their proximal ends.

4. The apparatus of claim 1, further comprising a lock configured to releasably secure the body to the proximal end region of the endoscope shield.

5. The apparatus of claim 1, wherein the seal interface comprises an elastomeric seal.

6. The apparatus of claim 1, wherein the seal interface comprises multiple seals arranged in series.

7. The apparatus of claim 1, wherein the body is configured to couple to a port adapter of the endoscope shield.

8. The apparatus of claim 1, in which the body is a rigid pressure vessel.

9. The apparatus of claim 1, in which the body is a flexible pressure vessel.

10. The apparatus of claim 1, in which the body is squeezeable and pressure is created by squeezing the body.

11. The apparatus of claim 1, wherein the seal interface comprises an outer interface surface that is configured to mate with an exterior surface of the port adapter, and an inner interface surface that is configured to mate with an interior surface of the port adapter.

12. The apparatus of claim 11, wherein the outer interface surface comprises a first seal, and the inner interface surface includes a second seal.

13. The apparatus of claim 12, wherein the second seal is an annular seal.

14. The apparatus of claim 1, further comprising a port seal configured to seal a pressure port on a proximal end of the endoscope shield.

15. An apparatus comprising: an endoscope shield comprising an external shield having a lumen configured to fit over an endoscope, an internal shield configured to fit into the endoscope, and a cap configured to engage with a distal end of the endoscope to secure the endoscope shield over the endoscope; a leak testing apparatus configured to couple to the endoscope shield and comprising: a body comprising an internal chamber, wherein the body is configured to sealingly couple the internal chamber to the endoscope shield, such that a pressurized fluid within the internal chamber can be applied to the endoscope shield to detect leakage of the fluid through the endoscope shield.

16. The apparatus of claim 15, such that it contains a chamber that is within the body so that the chamber is configured to receive at least a portion of the internal shield extending proximal to the external shield.

17. The apparatus of claim 15, in which the body comprises a flexible pressure vessel that has a volume that, when squeezed, delivers pressure to test the shield system for leak integrity.

18. The apparatus of claim 15, further comprising a seal interface configured to fluidically isolate the tubular cavity of the endoscope shield.

19. The apparatus of claim 15, wherein the endoscope shield is a rigidizing shield comprising a support layer, a rigidizing layer and a bladder layer, wherein the bladder layer is configured to be driven against the rigidizing layer by the application of pressure to rigidize the endoscope shield.

20. The apparatus of claim 15, wherein the body is configured to couple to a handle at a proximal end of the endoscope shield.

21. The apparatus of claim 15, further comprising a lock configured to releasably secure the body to the proximal end region of the endoscope shield.

22. The apparatus of claim 18, wherein the seal interface comprises an elastomeric seal.

23. The apparatus of claim 18, wherein the seal interface comprises multiple seals arranged in series.

24. The apparatus of claim 18, wherein the body is configured to couple to a port adapter of the endoscope shield.

25. The apparatus of claim 18, wherein the seal interface comprises an outer interface surface that is configured to mate with an exterior surface of the port adapter, and an inner interface surface that is configured to mate with an interior surface of the port adapter.

26. The apparatus of claim 25, wherein the outer interface surface comprises a first seal, and the inner interface surface includes a second seal.

27. The apparatus of claim 26, wherein the second seal is an annular seal.

28. The apparatus of claim 15, further comprising a port seal configured to seal a pressure port on a proximal end of the endoscope shield.

29. A method of testing an endoscope shield for a leak, the method comprising: sealingly coupling a leak testing device to a proximal end of an endoscope shield; applying positive or negative pressure within the leak testing device; and detecting any leak from the endoscope shield.

30. The method of claim 29, wherein sealing the leak testing device comprises coupling the leak testing device to the proximal end of the endoscope shield so that a sealed-off proximal end of an internal shield of the endoscope shield is within a chamber of the leak testing device.

31. The method of claim 29, wherein applying positive or negative pressure comprises applying negative pressure.

32. The method of claim 29, wherein applying positive or negative pressure comprises applying positive pressure.

33. The method of claim 29, wherein applying positive or negative pressure comprises squeezing the to deliver the leak testing pressure.

34. The method of claim 29, wherein sealing the leak testing device comprises engaging a seal interface of the leak testing device with the endoscope shield such that a chamber of the leaktesting device is in fluid communication with a lumen of the endoscope shield.

35. The method of claim 29, wherein applying fluid within the leak testing device comprises pressurizing a chamber of the leak testing device.

36. The method of claim 29, wherein checking for any leakage comprises immersing the endoscopic shield in a liquid and checking for any bubbles emanating from the pressurized endoscopic shield device.

37. The method of claim 29, wherein checking for any leakage comprises checking for liquid emanating from the pressurized endoscopic shield in air.

38. The method of claim 29, further comprising removing the endoscope shield from an endoscope before sealing the leak testing device to the endoscope shield.

39. The method of claim 29, wherein sealing the leak testing device comprises activating a lock to lock the leak testing device to the proximal end region of the endoscope shield.

40. The method of claim 29, wherein applying fluid within the leak testing device comprises applying air within the leak testing device.

41. The method of claim 29, wherein applying fluid within the leak testing device further comprises applying the fluid from a chamber of the leak testing device and between two or more layers of the endoscope shield.

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