Peroxide resistant flexible endoscope and reprocessing or sterilization method thereof

Abstract

A peroxide resistant endoscope includes an interface portion, a control portion coupled to the interface portion, and an insertion portion coupled to the control portion.

Description

Technical Field

[0001] The present disclosure generally relates to surgical devices, methods of manufacturing surgical devices, and methods of using surgical devices. More specifically, but not limited to, the disclosed embodiments relate to peroxide-resistant flexible endoscopes and methods of manufacturing, assembling, or using the same. Background Art

[0002] An endoscope is a surgical instrument that can be used to access (eg, view or remove) or treat tissue within a patient's body by inserting one or more medical tools through an incision or body orifice. Summary of the invention

[0003] A peroxide-resistant flexible endoscope according to a general configuration includes an interface portion, a control portion coupled to the interface portion, and an insertion portion coupled to the control portion. The insertion portion includes a bend, an insertion tube extending from the distal end of the control portion to the proximal end of the bend, and a distal tip at the distal end of the bend. The peroxide-resistant flexible endoscope also includes a light-carrying beam (LCB) extending from the interface portion to the distal tip. The outer shell of the bend is mainly composed of fluorocarbon rubber, the LCB is lubricated by a first lubricant, the first lubricant includes at least one solid lubricant and does not contain more than 10% by weight of molybdenum disulfide, and the outer shell of the insertion tube is bonded to the outer shell of the bend by an epoxy adhesive. A method for reprocessing (e.g., cleaning, cleaning and disinfection, cleaning and sterilization, etc.) or sterilization of such an endoscope is also disclosed. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1 is a schematic diagram of a flexible endoscope according to some embodiments.

[0005] Figure 2 is a schematic diagram of an example of a distal tip of a flexible endoscope according to some embodiments.

[0006] Figure 3 is a schematic diagram showing an example of articulation of a bending portion of a flexible endoscope according to some embodiments.

[0007] Figure 4 is a schematic diagram illustrating the angulated lines of a flexible endoscope according to some embodiments.

[0008] Figure 5A A flowchart illustrating a reprocessing process 500 for an endoscope according to some embodiments

[0009] Figure 5B A flow chart of a reprocessing process 502 for an endoscope is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0010] The disclosed embodiments include peroxide-resistant flexible endoscopes and methods for reprocessing or sterilizing such endoscopes. Advantageously, the disclosed embodiments allow an endoscope to undergo multiple sterilization cycles in an atmosphere of vaporized hydrogen peroxide without significant degradation.

[0011] As described herein, an endoscope generally includes a control portion (e.g., a handle) at a proximal end, an insertion tube extending between the control portion and the distal end, and an interface portion coupled to the control portion by an umbilical cord. The term "proximal end" (e.g., "proximal end") refers to a point or position that is closer to a doctor or other medical practitioner along the length of the endoscope during the use of the endoscope, and the term "distal end" (e.g., "distal end") refers to a point or position that is closer to the tissue location to be observed or treated in the patient's body along the length of the endoscope during the use of the endoscope. The types of endoscopes include, but are not limited to, for example, bronchoscopes, sinusoscopes, nasopharyngeal scopes, laryngoscopes, laparoscopes, gastroscopes, duodenoscopes, colonoscopes, ultrasonic endoscopes, hysteroscopes, cystoscopes, urethroscopes, urethroscopes, cardioscopes, and arthroscopes.

[0012] Figure 1 is a schematic diagram of an endoscope 100 that may be implemented as peroxide resistant. As used herein, the term "peroxide resistant" means that the endoscope can undergo multiple (e.g., 50, 100, 200) sterilization cycles in an atmosphere of vaporized hydrogen peroxide without experiencing at least some of the following defects, and in some examples without experiencing any of the following defects: peeling, cracking, deformation, fading (e.g., bleaching), or water resistance failure.

[0013] The endoscope 100 includes an insertion portion 110, a control portion 130, and an interface portion 170. The endoscope 100 is a flexible endoscope, which means that at least a portion of the insertion portion 110 (e.g., the bend 118) is bendable relative to the longitudinal axis of the insertion portion 110. The insertion portion 110 includes an insertion tube 112 coupled to the control portion 130 (e.g., a strain relief boot 134), a distal tip 114, and the bend 118 extending between the insertion tube 112 and the distal tip 114. The control portion 130 is connected to the interface portion 170 via an umbilical cord 190. In this example, the interface portion 170 includes a strain relief boot 172 coupled to the umbilical cord 190, a light guide plug or port 174, one or more electrical contacts 176, a water spray port 178, an air / water port 180, a ventilation connector 182, and a housing 184. In Figure 1 In the figure, for ease of illustration, the insertion portion 110 and the umbilical cord 190 are depicted in broken lines, indicating that the lengths of these components have been shortened. In a gastrointestinal endoscope (e.g., a gastroscope, a duodenoscope, a colonoscope), the length of each of the insertion portion 110 and the umbilical cord 190 may be up to approximately 1 meter or 1.5 meters.

[0014] The endoscope includes a light-carrying bundle or LCB, for example, an optical waveguide bundle, in particular, a fiber optic bundle including a large number of optical fibers and encapsulated in an elastomeric shell. In the following, a fiber optic bundle is used as an example of a light-carrying bundle. In other examples, other types of waveguides can be used instead of or in addition to the optical fibers. The number of individual fibers (or waveguides) in the LCB can range from several hundred to thousands, and the diameter of each fiber in the LCB can range from, for example, about 0.01 mm to 0.03 mm. In the endoscope 100, the LCB extends from the interface portion of the endoscope (e.g., from the optical fiber plug 174), through the umbilical cord 190, the control portion 130 and the insertion portion 110 to the distal tip 114, where it provides illumination to the working area in the patient's body via an optical glass window (also called an "illumination window") of the distal tip 114. Figure 2 A schematic diagram of an example 214 of a distal tip 114 is shown, the distal tip 114 including an objective lens 216 and an illumination window 217 attached to a body 215 of the distal tip 214 by an adhesive 218 .

[0015] -The LCB may be flexible, and it may bend with the tubes (e.g., umbilical cord 190, insertion portion 110) through which it extends. Such bending of the LCB may cause the fibers therein to slide against each other, and the friction generated by such movement may cause the fibers to break. Because it may be desirable to configure the bend 118 to bend to a smaller radius of curvature, for example, less than 10 cm, less than 5 cm in some examples, and less than 2 cm in one example, the risk of fiber breakage due to bending may be particularly high in the bend 118. In order to avoid fiber breakage by reducing friction with the fibers, the LCB is typically lubricated. For example, a lubricant may be applied to the fibers of the LCB to reduce friction therebetween. A lubricant may also be provided to reduce friction between the fibers and the inner surface of the shell of the LCB, and the outer surface of the shell of the LCB may also be lubricated to reduce friction between the LCB and other internal components of the endoscope (e.g., other tubes within the umbilical cord 190 and / or insertion portion 110, such as working channels, air and / or water channels, etc.). In addition to protecting the fibers from breakage, such lubrication may also reduce the force required to bend the tube through which the LCB extends.

[0016] The bend 118 is configured to allow the distal tip 114 to move at least laterally (e.g., from side to side) relative to the insertion tube 112. For example, the bend 118 can have an internal skeleton that includes an elongated cylinder that is bendable in at least one direction and at least one plane. Such an elongated cylinder can be formed by a series of generally cylindrical tubular members (e.g., rings) pivotally connected along a central axis or by some other articulated structure. In some embodiments, the bend 118 is bendable in two directions (e.g., up and down) in a plane. Figure 3Schematic diagram of such an embodiment 318 of the curved portion 118 is shown. In other embodiments, the curved portion 118 may also be bent in a second plane perpendicular (or substantially perpendicular) to the first plane. In this case, for example, the curved portion 118 may be bent in any direction of the upper, lower, left, and right directions.

[0017] The operator of the endoscope 100 can control such movement of the bending portion 118 by manipulating one or more actuators (e.g., control knobs) of the control portion 130. The force applied to the bending portion 118 at the control portion 130 can be provided, for example, by one or more angulated wires (also referred to as "control wires"). The angulated wires extend from the control portion 130 (e.g., from one or more actuators, which can be knobs or levers), through the insertion portion 110, to the distal end of the bending portion 118.

[0018] Figure 4 An example 400 of an endoscope 100 including angled lines 436 and 438 is shown. In this example, the angled lines 436 and 438 cause the curved portion 418 to bend in response to an applied force (e.g., a force applied by an operator of the endoscope) by rotating one or both of the control knobs 442 and 444. In order to reduce the amount of force that must be applied at the control 130 to achieve the desired movement of the curved portion 118, a lubricant may be applied to the surface of the angled lines.

[0019] Because an endoscope is used within the body, it is expected that it will become contaminated from such use and must be reprocessed (e.g., cleaned, disinfected, and / or sterilized) prior to its next use. Cleaning the endoscope can include soaking the endoscope in a cleaning solution (e.g., a solution containing at least one detergent and / or an enzymatic cleaner); it can also include mechanical cleaning, such as brushing one or more internal channels of the endoscope and / or wiping the exterior of the endoscope (e.g., using gauze and / or using a sponge).

[0020] Additionally or alternatively, cleaning the endoscope may include injecting a dispersion (e.g., suspension) stream of fine droplets of liquid in a gas into the lumen of an endoscope channel. The gas may include, for example, one or more of air, dinitrogen, or carbon dioxide or may be mainly composed thereof. The liquid may include, for example, one or more of osmotic water, distilled water, deionized water, or purified water (e.g., Type II laboratory grade purified water) or may be mainly composed thereof. In one example, the concentration of the surfactant in the liquid does not exceed 2 mg / L. The flow may be turbulent (e.g., the Reynolds number may be higher than 2300, such as in the range of 3500 to 100,000). The flow may be obtained from the output of the atomization chamber. The gas flow rate of the flow may be in the range of 10 to 100 liters per minute. The concentration of the droplets in the flow may vary over time (e.g., the frequency is in the range of 3 to 300 cycles per minute). This variation may be produced, for example, by providing the liquid to the atomization chamber as a pulsed discharge while providing the gas to the atomization chamber as a continuous flow. The injection may be performed continuously over a duration range of, for example, 60 to 600 seconds.

[0021] After cleaning the endoscope, a high-level disinfection (HLD) procedure may also be performed. The HLD procedure may include immersing the endoscope in a disinfection solution containing at least one high-level disinfectant. The high-level disinfectant may, for example, be configured to remove microorganisms (e.g., bacteria, viruses, mycobacteria, fungi, bacterial endospores, etc.) in or on the endoscope or a portion thereof. Examples of high-level disinfectants that may be included in the disinfection solution include glutaraldehyde (e.g., at a concentration of 2% or more, 2.4% or more, 3% or more), o-phthalaldehyde (OPA, e.g., at a concentration of 0.5% or more, 0.55% or more, 0.6% or more), and peracetic acid (e.g., at a concentration between 0.1% and 0.3%, such as about 0.2%; or at a concentration of at least 1820 mg / L).

[0022] After cleaning and / or HLD, one or more channels of the endoscope (e.g., any one or more of the endoscope channels described herein) may be dried. Such drying may be gravity-based and may be performed by hanging the endoscope in a drying cabinet (and possibly circulating heated, dried, filtered, and / or sterilized air within the cabinet and possibly under positive pressure). In another example, one or more channels may be dried by injecting a gas at a low flow rate (e.g., in the range of 10 to 30 degrees Celsius) at a low to moderate temperature (e.g., in the range of 10 to 30 degrees Celsius) to remove residual water (e.g., for a duration of 10 to 60 seconds), and then injecting a gas at a high flow rate (e.g., in the range of 20 to 100 liters per minute) at a high to moderate temperature (e.g., in the range of 30 to 60 degrees Celsius) (e.g., for a duration of 30 to 150 seconds). The gas may include, for example, at least one of dinitrogen or air or consist essentially of it. During the high flow rate, the gas may be a plasma (e.g., generated by an electrical discharge in a dinitrogen or air stream), which may sterilize the channel. In this case, the temperature of the plasma may be in the range of 20 to 80 degrees Celsius (eg, in the range of 30 to 50 degrees Celsius), and the duration of the plasma injection period may be in the range of 5 to 60 seconds.

[0023] Figure 5A A flow chart of a reprocessing process 500 for an endoscope (e.g., endoscope 100) is shown, the process 500 including cleaning the endoscope (e.g., according to any of the above examples) (block 510), performing a HLD procedure on the endoscope (e.g., according to any of the above examples) (block 520); drying the endoscope (e.g., according to any of the above examples) (block 530); and storing the endoscope in a cabinet (e.g., according to any of the above examples) (block 540). If such a process is performed using a liquid chemical sterilant (LCS) such as peracetic acid, a six-log reduction or more in the number of bacterial endospores can be achieved, and the process may be referred to as "just in time" (JIT) sterilization. An example of an LCS system that can be used for JIT sterilization is the Steris System 1E (Steris, Mentor, OH). If more than three weeks have passed since the HLD procedure 520 was performed, health and safety regulations may require that an endoscope that was reprocessed using JIT sterilization be reprocessed again before use.

[0024] Methods for sterilizing medical devices include autoclaving (e.g., sterilization using pressurized steam). However, flexible endoscopes are heat-sensitive devices that can be irreversibly damaged if temperature limits are exceeded. For example, a colonoscope, gastroscope, or duodenoscope can be damaged if reprocessed at temperatures exceeding 75 or even 60 degrees Celsius.

[0025] In addition to or as an alternative to HLD, it may be desirable to sterilize an endoscope, such as endoscope 100 , using a low temperature sterilization process. Figure 5B A flow chart of a reprocessing process 502 for an endoscope (e.g., endoscope 100) is shown, the process 502 including cleaning the endoscope (e.g., according to any of the above examples) (box 510), drying the endoscope (e.g., according to any of the above examples) (box 530); boxing and wrapping the endoscope (box 550); and low-temperature terminal sterilization of the endoscope (box 560). The term "terminal sterilization" means a process that has been demonstrated to achieve at least a 12-log reduction in bacterial endospores (e.g., with a validated sterilization assurance level (SAL) of no more than 10^-6). As used herein, the term "terminally sterilized endoscope" means an endoscope that has been sterilized using a process that has been validated to have a sterilization assurance level (SAL) of no more than 10^-6.

[0026] The boxing and wrapping of the endoscope (frame 550) can include packaging the endoscope in a sterilization package before the endoscope is subjected to the low temperature terminal sterilization process of frame 560. If the endoscope is still wrapped after the sterilization process of frame 560 is completed, the sterile life of the endoscope may be as long as 3 to 6 months. The sterilization package can be made of (e.g., including or consisting of) one or more nonwoven materials, such as multiple layers of extruded fibers (e.g., extruded polyolefin fibers). In some examples, the sterilization package includes one or more meltblown inner layers of extruded polyolefin fibers, which are enclosed between two spunbond outer layers of extruded polyolefin fibers. An example of such a product is the Halyard SMART-FOLD* sterilization package (Owens & Minor, Richmond, VA).

[0027] One example of a low temperature terminal sterilization process of block 560 includes confining the endoscope in a moist sterilizing atmosphere of ethylene oxide (EtO), typically at a temperature between 37 and 63 degrees Celsius, for a specified period of time (e.g., 1 to 6 hours). However, due to the high toxicity of EtO, such a process also requires a subsequent degassing period of up to 48 hours before the endoscope can be used.

[0028] Another example of a low temperature sterilization process of block 560 includes confining the endoscope in a sterilizing atmosphere of vaporized hydrogen peroxide (VHP) for a specified period of time (e.g., 60 to 70 minutes). Such a process may use a high concentration (e.g., 50% to 70%, such as 59%) of hydrogen peroxide and / or may be performed in a vacuum (e.g., at a pressure of 14 Torr or less). The temperature at which such a process is performed may be less than about 70 degrees Celsius (e.g., less than about 65, 60, or 55 degrees Celsius). An example of a VHP system that can be used for terminal sterilization is the Steris VPro Max (Steris, Mentor, OH). Such a process may include applying an electric field to a sterilization chamber to generate a plasma, in which case the duration of exposure of the endoscope to the plasma may be in the range of 5 to 30 minutes. An example of a VHP system that includes such plasma generation and can be used for terminal sterilization is the Sterrad 100NX (Advanced Sterilization Products, Irvine, CA).

[0029] As mentioned above, lubrication of the LCB and / or the angled lines of the endoscope is important to avoid damage to the endoscope and to achieve the desired articulation performance. Molybdenum disulfide is a solid lubricant commonly used for both purposes. Unfortunately, molybdenum disulfide is incompatible with vaporized hydrogen peroxide used for endoscope sterilization because it may react with vaporized hydrogen peroxide to form sulfuric acid and sulfurous acid. These acids may attack the elastomers and other components of the endoscope and may cause the elastomers to become brittle, degrade, and / or crack after only 8 or 12 sterilization cycles.

[0030] It may be desirable to lubricate the LCB and / or angled wire of an endoscope without using any molybdenum disulfide. To this end, the endoscope may include a first lubricant that lubricates the LCB. The first lubricant may include at least one solid lubricant and may be free of (e.g., free of any) molybdenum disulfide. In one example, a mixture (e.g., a suspension or dispersion) of fluorinated carbon (graphite fluoride) in silicone oil is used as a first lubricant to lubricate the LCB of a peroxide-resistant endoscope (e.g., endoscope 100). For example, such a mixture may be used to replace a lubricant containing molybdenum disulfide. Such a mixture may be used to coat the fibers of the LCB and / or to coat the inner surface of the shell of the LCB. Alternatively or additionally, such a mixture may also be used to coat the outer surface of the shell of the LCB. An example of a fluorinated carbon suitable for use in such a mixture has the trade name CEFBON CMC (CentralGlass Co., Ltd., Tokyo, JP), which is characterized by a fluorine content of 62 to 64% by weight and an average particle size of 5 microns. In other examples, fluorinated carbons having different fluorine contents and / or different average particle sizes may be used. The fluorine content may be, for example, not less than 40% by weight, in some examples not less than 50% by weight, in one example not less than 60% by weight, and / or may be not more than 80% by weight, in some examples not more than 70% by weight, and in one example not more than 65% by weight. The average particle size may be, for example, not less than 2 microns, in some examples not less than 4 microns, and / or may be not more than 10 microns, and in some examples not more than 6 microns.

[0031] Alternatively, the first lubricant may include at least one solid lubricant (e.g., according to any of the examples described in the previous paragraph) and may also contain a small amount (e.g., no more than 15 wt % or 20 wt %) of molybdenum disulfide. In one example, because the endoscope 100 described herein has been shown to withstand peroxides for up to 125 reprocessing cycles even with a certain amount of molybdenum disulfide in the first lubricant, the amount of molybdenum disulfide in the first lubricant does not exceed 10 wt %. In another example, the amount of molybdenum disulfide in the first lubricant does not exceed 5 wt %, and in another example, the amount of molybdenum disulfide in the first lubricant does not exceed 2 wt %.

[0032] Additionally or alternatively, the endoscope may include a second lubricant that lubricates the angled wires. The second lubricant may include at least one solid lubricant and may be free of (e.g., free of any) molybdenum disulfide. In some examples, the second lubricant may be different from the first lubricant. In one example, nanographite is used as a second lubricant to lubricate one or more (possibly all) angled wires of a peroxide-resistant endoscope (e.g., endoscope 100). Such a lubricant may, for example, be used in place of a lubricant containing molybdenum disulfide. The average particle size of the nanographite may be in the range of 0.2 to 50 microns, in some examples in the range of 1 to 30 microns, and in one example in the range of 5 to 20 microns.

[0033] In another example, a mixture of nanographite and powdered PTFE is used as a second lubricant to lubricate one or more (possibly all) angled lines of a peroxide-resistant endoscope (e.g., endoscope 100). For example, this mixture can be used to replace a lubricant containing molybdenum disulfide. The average particle size of the nanographite in the mixture can be in the range of 0.2 to 50 microns, in some examples in the range of 1 to 30 microns, and in one example in the range of 5 to 20 microns. The average particle size of the powdered PTFE in the mixture can be in the range of 0.1 to 50 microns, in some examples in the range of 1 to 30 microns, and in one example in the range of 5 to 20 microns.

[0034] Alternatively, the second lubricant may include at least one solid lubricant (e.g., according to any of the examples described in the previous two paragraphs), and may also contain a small amount (e.g., no more than 15 wt % or 20 wt %) of molybdenum disulfide. In one example, the amount of molybdenum disulfide in the second lubricant does not exceed 10 wt %; in another example, the amount of molybdenum disulfide in the second lubricant does not exceed 5 wt %; in another example, the amount of molybdenum disulfide in the second lubricant does not exceed 2 wt %.

[0035] Even without molybdenum disulfide, the strong oxidizing effect of the atmosphere of vaporized hydrogen peroxide may degrade components of the endoscope (e.g., elastomers, adhesives), and the free radicals generated using the plasma may also degrade components that would not otherwise be oxidized by the vaporized hydrogen peroxide. Thus, it may be desirable to implement elastomeric (e.g., rubber) components of the endoscope 100 using peroxide-resistant materials.

[0036] In the endoscope 100, the housing of the insertion tube 112 and / or the umbilical cord 190 can be made of (e.g., include or consist of) polyurethane, which is resistant to degradation due to repeated exposure to an atmosphere of vaporized hydrogen peroxide. Although polyurethane is inexpensive and inert, it may not be flexible enough to be used in other components of the peroxide-resistant endoscope, such as the housing of the bend and the strain relief boot. These components of the endoscope may require the use of a more flexible peroxide-resistant material than polyurethane, such as fluorocarbon rubber or silicone rubber.

[0037] In one example, the outer shell of the curved portion 118 of the endoscope 100 is made of (e.g., includes or consists of) fluorocarbon rubber. In some examples, the outer shell of the curved portion 118 can be composed primarily of fluorocarbon rubber, meaning that the outer shell can also contain additives other than fluorocarbon rubber that do not substantially affect its resistance to VHP or the reaction product of molybdenum disulfide and VHP. For example, the fluorocarbon rubber content of the outer shell of the curved portion 118 can be at least 80% by weight, in some examples at least 90% by weight, in one example at least 95% by weight, and in one example at least 98% by weight. The fluorocarbon rubber can be three-dimensionally cross-linked.

[0038] Alternatively or in addition, one or more strain relief boots of the peroxide resistant endoscope can be made of (e.g., include or consist of) silicone rubber. For example, one or more of the strain relief boots 132, 134, and 172 of the endoscope 100 can be made of silicone rubber. In some examples, one or more strain relief boots may be primarily composed of silicone rubber, meaning that the strain relief boots may also contain additives other than silicone rubber that do not substantially affect their resistance to VHP or the reaction products of molybdenum disulfide and VHP. For example, the silicone rubber content of the corresponding strain relief boots can be at least 80 weight percent, in some examples at least 90 weight percent, in one example at least 95 weight percent, and in one example at least 98 weight percent. Other flexible components of the endoscope 100 that can be made of silicone rubber include a cover for each of the one or more control buttons of the control portion 130 and / or one or more port covers.

[0039] Other components of the endoscope that may degrade (e.g., peel, crack, deform, or fade) after repeated exposure to vaporized hydrogen peroxide may include adhesives and coatings. It may be desirable to use epoxy compounds to implement one or more adhesives or coatings of the endoscope 100. In one example, the adhesive 218 that secures the illumination window 217 to the body 215 of the distal tip 214 is an epoxy adhesive. The epoxy adhesive may be a two-component adhesive including a base resin and a curing agent (e.g., a hardener), and may also include other components (e.g., one or more fillers (e.g., silica) or colorants (e.g., carbon black)). The base resin may include, for example, a bisphenol A epoxy resin (e.g., bisphenol A, epichlorohydrin polymer; also known as bisphenol A type liquid epoxy resin, CAS no. 25068-38-6 or Japanese ENCS no. 7-1283). The curing agent may include, for example, polyamidoamine. The ratio of base resin to curing agent in the epoxy adhesive (by weight) can be greater than 2:1, can be at least 2.5:1 in some examples, and can be at least 2.8:1 or 2.9:1 in some examples. In these or other examples, the ratio of base resin to curing agent in the epoxy adhesive (by weight) can be no more than 4:1, can be no more than 3.5:1 in some such examples, and can be no more than 3.2:1 or 3.1:1 in some such examples. The bend 118 can be at least partially secured to the insertion tube 112 by an epoxy adhesive (e.g., an epoxy adhesive according to any of the examples described above). The distal tip 114 (e.g., the distal tip 214) can be at least partially secured to the bend 118 by an epoxy adhesive (e.g., an epoxy adhesive according to any of the examples described above).

[0040] In any of these cases, curing of the adhesive bond may include maintaining the temperature of the joint to which the epoxy adhesive is applied within a curing temperature range for a curing time. The curing temperature range may be, for example, within 1%, 2%, 5%, or 10% of the curing point temperature. In some examples, the curing point temperature may be 75 degrees Celsius; in other examples, the curing point temperature may be 80 degrees Celsius; in other examples, the curing point temperature may be 85 degrees Celsius; in other examples, the curing point temperature may be 90 degrees Celsius. The curing time may be at least 90 minutes, in some examples at least 115 minutes, in some examples at least 120 minutes, and in some examples at least 115 minutes and no more than 135 minutes.

[0041] Additionally or alternatively, the adhesive that secures the electrical contacts 176 to the housing 184 of the interface portion 170 may be an epoxy adhesive (e.g., an epoxy adhesive according to any of the examples described above). In some examples, an epoxy coating (e.g., a two-component epoxy adhesive, wherein the ratio of base resin to curing agent (by weight) may be greater than 2:1, may be at least 2.5:1 in some examples, and may be at least 2.8:1 or 2.9:1 in some examples, and may be no greater than 4:1, may be no greater than 3.5:1 in some such examples, and may be no greater than 3.2:1 or 3.1:1 in some such examples) may be used to coat the outer surface of the housing of the insertion tube 112 and / or the connection between the housing of the insertion tube 112 and the curved portion 118 (e.g., an adhesive).

[0042] Other components of the endoscope may degrade (e.g., peel, crack, deform, or discolor) after repeated exposure to vaporized hydrogen peroxide, including metal components and plastic components. It may be desirable to implement these components using peroxide-resistant materials, such as stainless steel, polyphenylene oxide, polyolefin, or polyethylene terephthalate (PET). In one example, one or more ports and / or connectors of the interface portion 170, one or more ports of the control portion 130, and / or the body 215 of the distal tip 214 are made or formed of stainless steel. Additionally or alternatively, the housing 184 of the interface portion, the housing of the control portion 130, and / or one or more actuators (e.g., one or more control knobs and / or levers) of the control portion 130 may be made of (e.g., include or consist of) polyphenylene oxide. In some examples, one or more plastic labels (e.g., indicating a model, serial number, direction, warning, etc.) on the interface portion 170 and / or the control portion 130 may be made of (e.g., include or consist of) polyolefin and / or PET.

[0043] The principles described herein can be practiced as described to achieve endoscope embodiments that provide advantages such as resistance to degradation (e.g., without any flaking, cracking, deformation, fading, or failure of water resistance) even after multiple cycles of exposure to vaporized hydrogen peroxide atmospheres.

[0044] Typically, because residual liquids may interfere with the sterilization process, the process of sterilizing an endoscope by confining it to an atmosphere of vaporized hydrogen peroxide, as described above, requires that the cleaned reusable medical device be very dry. Therefore, it may be necessary to dry the endoscope after cleaning is completed and before sterilization using vaporized hydrogen peroxide is initiated. Such drying may include gravity-based drying (e.g., in a drying cabinet) as described above and / or may include drying by injecting gas into one or more (e.g., all) channels of the endoscope as described above (e.g., at a low flow rate and medium-low temperature, then at a high flow rate and medium-high temperature). After drying is completed, the endoscope may be sterilized by confining it to an atmosphere of vaporized hydrogen peroxide. After the sterilization process is completed, no further drying is performed.

[0045] In some examples, a peroxide-resistant flexible endoscope (e.g., endoscope 100) according to any embodiment described herein is reprocessed by performing one or more cleaning processes (e.g., soaking, brushing, wiping, and / or injecting a flow of a dispersion described herein, and / or one or more other cleaning processes), and then performing one or more HLD processes (e.g., the HLD routine described herein and / or one or more other HLD processes). In other examples, a peroxide-resistant flexible endoscope (e.g., endoscope 100) according to any embodiment described herein is reprocessed by performing one or more cleaning processes (e.g., soaking, brushing, wiping, and / or injecting a flow of a dispersion described herein, and / or one or more other cleaning processes), and then performing one or more sterilization processes (e.g., confining the endoscope in a sterilizing atmosphere of vaporized hydrogen peroxide, and / or one or more other sterilization processes).

[0046] Further exemplary embodiments are provided below.

[0047] Example 1 includes an endoscope, which includes an interface portion; a control portion coupled to the interface portion; an insertion portion coupled to the control portion, the insertion portion including a bending portion, an insertion tube extending from the distal end of the control portion to the proximal end of the bending portion, and a distal tip at the distal end of the bending portion; and a light-carrying beam (LCB) extending from the interface portion to the distal tip. In this embodiment, the outer shell of the bending portion is mainly composed of fluorocarbon rubber, the first lubricant lubricating the LCB includes at least one solid lubricant and does not contain more than 10% by weight of molybdenum disulfide, the outer shell of the insertion tube is bonded to the outer shell of the bending portion by a first curing epoxy adhesive, and before the first epoxy adhesive is about to be cured: the first epoxy adhesive includes a first base resin component and a first curing agent, and the weight ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5 (two and one-half):1.

[0048] Example 2 includes an endoscope according to Example 1, wherein the outer shell of the insertion tube includes polyurethane.

[0049] Example 3 includes an endoscope according to any of Examples 1 and 2, wherein the at least one solid lubricant of the first lubricant includes a fluorinated carbon.

[0050] Example 4 includes an endoscope according to any of Examples 1 to 3, wherein the first lubricant includes silicone oil.

[0051] Example 5 includes an endoscope according to any of Examples 1 to 4, wherein the housing of the bending portion is bonded to the distal tip by a second epoxy adhesive.

[0052] Example 6 includes an endoscope according to any of Examples 1 to 5, wherein the distal tip includes a body and at least one piece of optical glass, and wherein the at least one piece of optical glass is bonded to the body by a third epoxy adhesive.

[0053] Example 7 includes an endoscope according to Example 6, wherein the body of the distal tip is formed of stainless steel.

[0054] Example 8 includes an endoscope according to any of Examples 6 and 7, wherein at least one piece of optical glass is bonded to the LCB.

[0055] Example 9 includes an endoscope according to any of the preceding examples, the endoscope further comprising at least one angled line extending through the insertion portion and configured to transmit force to cause the distal tip to move relative to the insertion tube, wherein a second lubricant that lubricates the at least one angled line comprises at least one solid lubricant and does not contain more than 10 weight percent molybdenum disulfide.

[0056] Example 10 includes an endoscope according to Example 9, wherein the at least one solid lubricant of the second lubricant includes nanographite.

[0057] Example 11 includes an endoscope according to any of Examples 9 and 10, wherein the at least one solid lubricant of the second lubricant includes polytetrafluoroethylene (PTFE).

[0058] Example 12 includes an endoscope according to any of the preceding examples, wherein the endoscope further includes a coating film covering an outer surface of the insertion tube housing, the coating film including a flexible epoxy adhesive.

[0059] Example 13 includes an endoscope according to any of the preceding examples, wherein the endoscope further comprises a strain relief boot coupled to the control portion and the insertion portion and consisting primarily of silicone rubber.

[0060] Example 14 includes an endoscope according to any of the preceding examples, wherein the first lubricant does not contain more than 2 weight percent molybdenum disulfide.

[0061] Example 15 includes a method of reprocessing an endoscope according to any of Examples 1 to 14, the method comprising exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

[0062] Example 16 includes the method of Example 15, further comprising exposing the lumen of at least one channel of the endoscope to at least one of: a disinfecting solution containing at least one high-level disinfectant or a cleaning solution containing at least one detergent or enzymatic cleaner.

[0063] Example 17 includes the method of Example 16, further comprising drying the endoscope after exposing the lumen of the at least one channel to at least one of the disinfecting solution and the cleaning solution and before exposing the endoscope to the atmosphere containing vaporized hydrogen peroxide.

[0064] Example 18 includes the method of Example 15, further comprising drying the endoscope prior to exposing the endoscope to the atmosphere containing vaporized hydrogen peroxide.

[0065] Example 19 includes the method of any of Examples 17 and 18, wherein drying the endoscope comprises hanging the endoscope in a drying cabinet.

[0066] Example 20 includes the method of any of Examples 17 and 18, wherein drying the endoscope comprises injecting a gas into one or more channels of the endoscope.

[0067] Example 21 includes the method of Example 20, wherein drying the endoscope comprises injecting gas into one or more channels at a flow rate of 1 to 20 liters per minute and a temperature of 10 to 30 degrees Celsius, followed by injecting gas into one or more channels at a flow rate of 20 to 100 liters per minute and a temperature of 30 to 60 degrees Celsius.

[0068] The foregoing description is given for the purpose of illustration. It is not exhaustive and is not limited to the precise forms or embodiments disclosed. Modifications and adaptations to the embodiments will be apparent from consideration of the disclosed specification and practice. Furthermore, although certain components are described as being coupled to each other, these components may be integrated with each other or distributed in any suitable manner.

[0069] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., aspects of the various embodiments), adaptations, and / or changes based on the present disclosure. The elements in the claims are to be interpreted in a broad manner based on the language employed in the claims, and are not limited to the examples described in this specification or during prosecution of the application, which examples are to be interpreted as non-exclusive.

[0070] According to the detailed description, the features and advantages of the present disclosure are obvious, therefore, the attached claims are intended to cover all systems and methods that fall within the true spirit and scope of the present disclosure. As used herein, the indefinite articles "one" and "an" refer to "one or more". Similarly, the use of plural terms does not necessarily mean plural unless it is clear in a given context. Unless otherwise explicitly stated, words such as "and" or "or" mean "and / or". For the purpose of this document, the phrase "A is based on B" means "A is at least based on B". As used herein, the terms "substantially", "approximately" or "about" can be replaced with "[percentage] within" specified, where percentages include 0.1%, 1%, 5% and 10%. Further, since many modifications and changes are easily seen by studying the present disclosure, it is not expected that the present disclosure will be limited to the exact configuration and operation shown and described, so all suitable modifications and equivalents falling within the scope of the present disclosure can be adopted.

[0071] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein.It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosed embodiments being indicated by the following claims.

Claims

1. An endoscope, comprising: Interface department; a control portion coupled to the interface portion; an inserting portion coupled to the control portion, the inserting portion comprising: Bending part, an insertion tube extending from the distal end of the control portion to the proximal end of the bending portion, and a distal tip at the distal end of the bend; and A light carrying beam (LCB) extending from the interface portion to the distal tip, in, The outer shell of the bending part is mainly composed of fluorocarbon rubber. A first lubricant for lubricating the LCB includes at least one solid lubricant and does not contain more than 10 wt. % of molybdenum disulfide, and The outer shell of the insertion tube is bonded to the outer shell of the bending portion by a first cured epoxy adhesive, and Wherein, before the first epoxy adhesive is about to be cured: The first epoxy adhesive comprises a first base resin component and a first curing agent, and The weight ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5, i.e., two and a half:

1.

2. The endoscope according to claim 1, characterized in that The outer shell of the insertion tube includes polyurethane.

3. The endoscope according to claim 1, characterized in that The at least one solid lubricant of the first lubricant includes a fluorinated carbon.

4. The endoscope according to claim 1, characterized in that The first lubricant includes silicone oil.

5. The endoscope according to claim 1, characterized in that The housing of the bend is bonded to the distal tip by a second epoxy adhesive.

6. The endoscope according to claim 1, characterized in that The distal tip includes a body and at least one piece of optical glass, and Wherein, the at least one piece of optical glass is bonded to the main body by a third epoxy adhesive.

7. The endoscope according to claim 6, characterized in that The body of the distal tip is formed from stainless steel.

8. The endoscope according to claim 6, characterized in that The at least one piece of optical glass is bonded to the LCB.

9. The endoscope of claim 1, further comprising at least one angled line extending through the insertion portion and configured to transmit a force to cause the distal tip to move relative to the insertion tube, It is characterized in that The second lubricant lubricating the at least one angled line includes at least one solid lubricant and does not contain more than 10 wt % of molybdenum disulfide.

10. The endoscope according to claim 9, characterized in that The at least one solid lubricant of the second lubricant includes nanographite.

11. The endoscope according to claim 9, characterized in that: The at least one solid lubricant of the second lubricant includes polytetrafluoroethylene (PTFE).

12. The endoscope according to claim 1, characterized in that The endoscope further includes a coating film covering an outer surface of the outer shell of the insertion tube, the coating film including a flexible epoxy adhesive.

13. The endoscope according to claim 1, characterized in that The endoscope also includes a strain relief shoe coupled to the control portion and the insertion portion and made primarily of silicone rubber.

14. The endoscope according to claim 1, characterized in that The first lubricant does not contain more than 2 weight percent of molybdenum disulfide.

15. The method of reprocessing an endoscope according to claim 1, comprising exposing the endoscope to an atmosphere comprising vaporized hydrogen peroxide.

16. The method of claim 15, further comprising exposing the lumen of at least one channel of the endoscope to at least one of: A disinfectant solution containing at least one high-level disinfectant, or A cleaning solution comprising at least one detergent or an enzymatic cleaner.

17. The method of claim 16, further comprising drying the endoscope after exposing the lumen of the at least one channel to at least one of a disinfecting solution and a cleaning solution and before exposing the endoscope to the atmosphere comprising vaporized hydrogen peroxide.

18. The method of claim 15, further comprising drying the endoscope prior to exposing the endoscope to the atmosphere comprising vaporized hydrogen peroxide.

19. The method according to claim 17, characterized in that The drying the endoscope includes hanging the endoscope in a drying cabinet.

20. The method according to claim 17, characterized in that The drying the endoscope includes injecting a gas into one or more channels of the endoscope.

21. The method according to claim 20, characterized in that The drying of the endoscope includes injecting the gas into the one or more channels at a flow rate of 1 to 20 liters per minute and a temperature of 10 to 30 degrees Celsius, and then injecting the gas into the one or more channels at a flow rate of 20 to 100 liters per minute and a temperature of 30 to 60 degrees Celsius.

Images