Peroxide-resistant flexible endoscope and method for reprocessing or sterilizing such an endoscope

Abstract

The peroxide-resistant endoscope includes an interface section, a control section coupled to the interface section, and an insertion section coupled to the control section.

Description

[Technical Field]

[0001] The present disclosure relates generally to surgical devices, methods of manufacturing surgical devices, and methods of using surgical devices. More specifically, but not by way of limitation, the disclosed embodiments relate to peroxide-resistant flexible endoscopes and methods for manufacturing, assembling, or using such devices. [Background technology]

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

[0003] A peroxide-resistant flexible endoscope according to a general configuration includes an interface section, a control section coupled to the interface section, and an insertion section coupled to the control section. The insertion section includes a curved section, an insertion tube extending from the distal end of the control section to the proximal end of the curved section, and a tip section at the distal end of the curved section. The peroxide-resistant flexible endoscope also includes a light-carrying bundle (LCB) extending from the interface section to the tip section. The outer casing of the curved section consists essentially of fluorocarbon rubber, and the LCB is lubricated with a first lubricant including at least one solid lubricant and not containing more than 10% molybdenum disulfide by weight. The outer casing of the insertion tube is bonded to the outer casing of the curved section with an epoxy adhesive. Methods for reprocessing (e.g., cleaning, cleaning and disinfecting, cleaning and sterilizing, etc.) or sterilizing such endoscopes are also disclosed. [Brief explanation of the drawings]

[0004] [Figure 1] 1 is a diagram of a flexible endoscope according to some embodiments. [Figure 2] 1 illustrates an example of a distal end of a flexible endoscope, according to some embodiments. [Figure 3]1 illustrates an example of articulation of a curved portion of a flexible endoscope, according to some embodiments. [Figure 4] 10A-10C illustrate angulation wires for a flexible endoscope, according to some embodiments. [Figure 5A] FIG. 5 illustrates a flowchart of a process 500 for reprocessing an endoscope, according to some embodiments. [Figure 5B] FIG. 5 illustrates a flowchart of a process 502 for reprocessing an endoscope, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0005] Disclosed embodiments include peroxide-resistant flexible endoscopes and methods for reprocessing or sterilizing such endoscopes. Advantageously, embodiments of the present disclosure enable endoscopes that can undergo many cycles of sterilization in an atmosphere of vaporized hydrogen peroxide without significant decomposition.

[0006] As described herein, an endoscope typically includes a control section (e.g., a handle) at a proximal end, a distal (or "sensing") end, an insertion tube extending between the control section and the distal end, and an interface section connected to the control section by an umbilical cord. The term "proximal" (e.g., "proximal end") refers to a point or location along the length of the endoscope that is closer to a physician or other medical practitioner when the endoscope is in use, and the term "distal" (e.g., "distal end") refers to a point or location along the length of the endoscope that is closer to the location of tissue to be observed or treated within a patient when the endoscope is in use. Types of endoscopes include, but are not limited to, bronchoscopes, sinusoscopes, nasopharyngoscopes, laryngoscopes, laparoscopes, gastroscopes, duodenoscopes, colonoscopes, echoscopes, hysteroscopes, cystoscopes, uroscopes, urethroscopes, cardioscopes, and arthroscopes.

[0007] 1 is a diagram of an endoscope 100 that may be implemented to be peroxide resistant. As used herein, the term "peroxide resistant" means that the endoscope can undergo many cycles of sterilization (e.g., 50, 100, 200) in an atmosphere of vaporized hydrogen peroxide without experiencing at least some of the following defects, and in some instances, none of the following defects: peeling, cracking, deformation, discoloration (e.g., bleaching), or failure to be watertight.

[0008] The endoscope 100 includes an insertion section 110, a control unit 130, and an interface unit 170. The endoscope 100 is a flexible endoscope, meaning that at least a portion of the insertion section 110 (e.g., a curved section 118) is bendable relative to the longitudinal axis of the insertion section 110. The insertion section 110 includes an insertion tube 112 coupled to the control unit 130 (e.g., to a strain relief boot 134), a tip section 114, and the curved section 118 extending between the insertion tube 112 and the tip section 114. The control unit 130 is further connected to the interface unit 170 via an umbilical cord 190. In this example, the interface unit 170 includes a strain relief boot 172 joined to the umbilical cord 190, a light guide plug or port 174, one or more electrical contacts 176, a water jet port 178, an air / water port 180, a vent connector 182, and a housing 184. 1, the insertion section 110 and umbilical cord 190 are shown in dashed lines and are shown at reduced length. In a gastrointestinal endoscope (e.g., a gastroscope, duodenoscope, or colonoscope), the insertion section 110 and umbilical cord 190 may be up to about 1 meter or 1.5 meters in length.

[0009] The endoscope includes a light-carrying bundle or LCB, e.g., a light guide fiber bundle, particularly a light guide fiber bundle containing multiple optical fibers housed within an elastomeric casing. Hereinafter, reference will be made to a light guide fiber bundle as an example of a light-carrying bundle. In other examples, other types of waveguides may be used instead of or in addition to optical fibers. The number of individual fibers (or waveguides) within the LCB may range from several hundred to over 1,000, and each fiber within the LCB may have a diameter, for example, in the range of approximately 0.01 to 0.03 mm. In the endoscope 100, the LCB extends from the endoscope's interface section (e.g., from the light guide plug 174), through the umbilical cord 190, the control section 130, and the insertion section 110, to the distal end 114, where it provides illumination to the working area within the patient's body through an optical glass window (also referred to as an "illumination window") in the distal end 114. FIG. 2 shows a diagram of an example tip 214 including an objective lens 216 and an illumination window 217 attached to the body 215 of the tip 114 by adhesive 218 .

[0010] The LCB may be flexible and may curve along with the tube through which it extends (e.g., the umbilical cord 190, the insertion section 110). Such bending of the LCB can cause fibers within the LCB to slide against one another, and the friction caused by such movement can lead to fiber breakage. The risk of fiber breakage due to bending can be particularly high in the curved section 118, as it may be desirable to configure the curved section 118 to curve with a small radius of curvature, e.g., less than 10 cm, in some instances less than 5 cm, and in one instance less than 2 cm. To reduce friction against the fibers and thereby avoid fiber breakage, the LCB is typically lubricated. For example, the fibers of the LCB may be coated with a lubricant to reduce friction between them. A lubricant may also be provided to reduce friction between the fibers and the inner surface of the LCB casing, and the outer surface of the LCB casing may be further 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 the insertion section 110, such as the working channel, air and / or water lines, etc.). In addition to protecting the fibers from breakage, such lubrication can also reduce the force required to bend the tube through which the LCB extends.

[0011] The curved portion 118 is configured to allow the tip 114 to move at least laterally (e.g., side to side) relative to the insertion tube 112. For example, the curved portion 118 may have an inner skeleton including an elongated cylinder that is bendable in at least one direction and at least one plane. Such an elongated cylinder may be formed by a series of substantially cylindrical tubular members (e.g., rings) pivotally connected along a central axis or by other articulatable structures. In some implementations, the curved portion 118 is bendable in two directions within a plane (e.g., up and down). FIG. 3 shows a diagram of such an embodiment 318 of the curved portion 118. In other embodiments, the curved portion 118 is also bendable in a second plane that is perpendicular (or substantially perpendicular) to the first plane. In this case, for example, the curved portion 118 may be bendable in both the up, down, left, and right directions.

[0012] Such movement of the curved portion 118 can be controlled by an operator of the endoscope 100 by manipulating one or more actuators, e.g., control knobs, of the control unit 130. The force applied by the control unit 130 may be provided to the curved portion 118, for example, by one or more angulation wires (also referred to as "control wires") that extend from the control unit 130 (e.g., from one or more actuators, which may be knobs or levers), through the insertion portion 110, and to the distal end of the curved portion 118.

[0013] 4 shows an example 400 of endoscope 100 that includes angulation wires 436 and 438. In this example, by rotating one or both of control knobs 442 and 444, angulation wires 436 and 438 bend bending portion 418 in response to an applied force (e.g., by an endoscope operator). The surfaces of the angulation wires may be coated with a lubricant to reduce the amount of force that must be applied to control portion 130 to achieve a desired movement of bending portion 118.

[0014] Because endoscopes are used inside the body, they are expected to become contaminated through such use and must be reprocessed (e.g., cleaned, disinfected, and / or sterilized) before subsequent use. Cleaning an endoscope can include soaking the endoscope in a cleaning solution (e.g., a solution containing at least one detergent and / or enzymatic cleaner) and can also include mechanical cleaning, such as brushing one or more internal passages of the endoscope and / or wiping the exterior of the endoscope (e.g., with gauze and / or a sponge).

[0015] Additionally or alternatively, flushing an endoscope may include injecting a stream of a dispersion (e.g., suspension) of fine droplets of liquid in a gas into the internal lumen of the endoscope passage. The gas may include, or consist essentially of, one or more of, for example, air, dinitrogen, or carbon dioxide. The liquid may include, or consist essentially of, one or more of, for example, osmotic water, distilled water, deionized water, or purified water (e.g., Type II laboratory-grade purified water). In one example, the concentration of surfactant in the liquid does not exceed 2 mg / L. The stream may be turbulent (e.g., have a Reynolds number greater than 2300, such as in the range of 3500 to 100,000). The stream may be obtained from the output of an atomization chamber. The gas flow rate of the stream may be in the range of 10 to 100 liters per minute. The concentration of droplets in the stream may vary over time (e.g., at a frequency in the range of 3 to 300 cycles per minute). Such a change can be produced, for example, by supplying the gas to the atomization chamber as a continuous stream while supplying the liquid to the atomization chamber as pulsed injectors, which may be continuous for durations ranging from, for example, 60 to 600 seconds.

[0016] After cleaning the endoscope, a high-level disinfection (HLD) routine can be performed. The HLD routine can include immersing the endoscope in a disinfectant solution containing at least one high-level disinfectant. The high-level disinfectant can be configured, for example, to eliminate microorganisms (e.g., bacteria, viruses, mycobacteria, fungi, bacterial endospores, etc.) in or on the endoscope or portions thereof. Examples of high-level disinfectants that can be included in the disinfectant solution include glutaraldehyde (e.g., at a concentration of 2% or more, 2.4% or more, 3% or more), orthophthalaldehyde (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 of 0.1% to 0.3%, e.g., about 0.2%, or at a concentration of at least 1820 mg / L).

[0017] After cleaning and / or HLD, one or more of the endoscope's conduits (e.g., any one or more of the endoscope conduits described herein) can be dried. Such drying can be gravity-based or can be performed by suspending the endoscope in a drying cabinet (and circulating heated, dried, filtered, and / or sterilized air, optionally under positive pressure, within the cabinet). In another example, one or more conduits can be dried by injecting gas at a low to moderate temperature (e.g., in the range of 10 to 30 degrees Celsius) at a low flow rate (e.g., in the range of 1 to 20 liters per minute) to remove residual water (e.g., for a duration of 10 to 60 seconds), followed by injecting gas at a high flow rate (e.g., in the range of 20 to 100 liters per minute) at a moderate to high temperature (e.g., in the range of 30 to 60 degrees Celsius) (e.g., for a duration of 30 to 150 seconds). The gas can include, or consist essentially of, at least one of nitrogen and air, for example. During periods of high flow, the gas may be plasma (e.g., generated by discharge in a nitrogen or air stream) capable of sterilizing the pipeline. In such cases, the temperature of the plasma may be within a range of 20 to 80 degrees Celsius (e.g., within a range of 30 to 50 degrees Celsius), and the duration of the plasma injection period may be within a range of 5 to 60 seconds.

[0018] FIG. 5A shows a flowchart of a process 500 for reprocessing an endoscope (e.g., endoscope 100), including the steps of sanitizing the endoscope (e.g., according to any of the above examples) (block 510), performing an HLD routine 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). When such a process is performed using a liquid chemical sterilant (LCS) (e.g., peracetic acid), a 6-log or greater reduction in the number of bacterial endospores can be achieved, and this process may be referred to as "just-in-time" (JIT) sterilization. One example of an LCS system that may be used for JIT sterilization is the Steris System 1E (Steris, Mentor, Ohio). Health and safety regulations may require endoscopes reprocessed using JIT sterilization to be reprocessed before use if more than three weeks have passed since the HLD routine 520 was performed.

[0019] Sterilization methods for medical devices include autoclaving (e.g., sterilization using steam under pressure). However, flexible endoscopes are heat-sensitive devices and can be irreversibly damaged if temperature limits are exceeded. Colonoscopes, gastroscopes, or duodenoscopes, for example, can be damaged if reprocessed at temperatures above 75 degrees Celsius or even 60 degrees Celsius.

[0020] In addition to or instead of HLD, it may be desirable to sterilize an endoscope (e.g., endoscope 100) using a low-temperature sterilization process. Figure 5B shows a flowchart of a process 502 for reprocessing an endoscope (e.g., endoscope 100), which includes cleaning the endoscope (e.g., according to any of the examples above) (block 510), drying the endoscope (e.g., according to any of the examples above) (block 530), boxing and packaging the endoscope (block 550), and subjecting the endoscope to a low-temperature terminal sterilization process (block 560). The term "terminal sterilization" refers to a process that has been demonstrated to achieve at least a 12-log reduction in bacterial endospores (e.g., verified with a sterility assurance level (SAL) of 10 or less). As used herein, the term "terminally sterilized endoscope" refers to an endoscope that has been sterilized using a process verified with a sterility assurance level (SAL) of 10 or less.

[0021] Boxing and packaging of the endoscope (block 550) can include wrapping the endoscope in a sterilization wrap before subjecting it to a low-temperature terminal sterilization process in block 560. If the endoscope remains wrapped after the sterilization process in block 560 is complete, the sterilization shelf life of the endoscope can be as long as three to six months. The sterilization wrap can be made of (e.g., includes or consists of) one or more nonwoven materials, such as multiple layers of extruded fibers (e.g., extruded polyolefin fibers). In some examples, the sterilization wrap includes one or more meltblown inner layers of extruded polyolefin fibers encapsulated between two spunbonded outer layers of extruded polyolefin fibers. One example of such a product is Halyard SMART-FOLD* Sterilization Wrap (Owens & Minor, Richmond, Virginia).

[0022] An example of a low-temperature terminal sterilization process at block 560 involves enclosing the endoscope in a moist sterilizing atmosphere of ethylene oxide (EtO) for a specified period of time (e.g., 1-6 hours), typically at a temperature between 37° C. and 63° C. 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.

[0023] Another example of a low-temperature sterilization process in block 560 involves enclosing the endoscope in a sterilizing atmosphere of vaporized hydrogen peroxide (VHP) for a specified period of time (e.g., 60-70 minutes). Such a process may use a high concentration of hydrogen peroxide (e.g., 50%-70%, e.g., 59%) and / or may be performed under vacuum (e.g., at a pressure of 14 Torr or less). The temperature at which such a process is performed may be below approximately 70°C (e.g., below approximately 65, 60, or 55°C). An example of a VHP system that may be used for terminal sterilization is the Steris VPro Max (Steris, Mentor, Ohio). Such a process may include applying an electric field to the sterilization chamber to generate plasma; in such cases, the duration of exposure of the endoscope to the plasma may be within the range of 5-30 minutes. An example of a VHP system that includes such plasma generation and may be used for terminal sterilization is the Sterrad 100NX (Advanced Sterilization Products, Irvine, California).

[0024] As mentioned above, lubrication of the endoscope's LCB and / or angulation wires is important to avoid damage to the endoscope and achieve the desired articulation performance. Molybdenum disulfide is a solid lubricant commonly used for both purposes. Unfortunately, molybdenum disulfide is incompatible with the use of vaporized hydrogen peroxide for endoscope sterilization because molybdenum disulfide can react with vaporized hydrogen peroxide to form sulfuric and sulfurous acids. These acids can attack the elastomers and other components of the endoscope, potentially causing the elastomers to embrittle, deteriorate, and / or crack after as few as eight or twelve sterilization cycles.

[0025] It may be desirable to lubricate the LCB and / or angulation wires of an endoscope without using molybdenum disulfide. To this end, the endoscope can include a first lubricant for lubricating the LCB. The first lubricant may include at least one solid lubricant and may not include (e.g., contain) molybdenum disulfide. In one example, a mixture (e.g., a suspension or dispersion) of carbon fluoride (graphite fluoride) in silicone oil is used as a first lubricant for lubricating the LCB of a peroxide-resistant endoscope (e.g., endoscope 100). Such a mixture may be used, for example, in place of a lubricant containing molybdenum disulfide. Such a mixture can be used to coat the fibers of the LCB and / or to coat the inner surface of the LCB casing. Alternatively or additionally, such a mixture can also be used to coat the outer surface of the LCB casing. One example of a fluorocarbon that may be suitable for use in such a mixture has the trade name CEFBON CMC (Central Glass Co., Ltd., Tokyo, Japan) and is characterized by a fluorine content of 62-64% by weight and an average particle size of 5 microns. In other examples, fluorocarbons with different fluorine contents and / or different average particle sizes may be used. The fluorine content may be, for example, 40% by weight or more, in some cases 50% by weight or more, in one case 60% by weight or more, and / or 80% by weight or less, in some cases 70% by weight or less, and in one case 65% by weight or less. The average particle size may be, for example, 2 microns or more, in some cases 4 microns or more, and / or 10 microns or less, in some cases 6 microns or less.

[0026] 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 include a small amount (e.g., 15 or 20% by weight or less) of molybdenum disulfide. In one example, the amount of molybdenum disulfide in the first lubricant does not exceed 10% by weight, as endoscope 100 as described herein has been shown to be peroxide resistant for up to 125 reprocessing cycles, even with such an amount of molybdenum disulfide in the first lubricant. In another example, the amount of molybdenum disulfide in the first lubricant does not exceed 5% by weight, and in a further example, the amount of molybdenum disulfide in the first lubricant does not exceed 2% by weight.

[0027] Additionally or alternatively, the endoscope may include a second lubricant for lubricating the angulation wires. The second lubricant may include at least one solid lubricant and may not include (e.g., contain) 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 for lubricating one or more angulation wire(s) of a peroxide-resistant endoscope (e.g., endoscope 100). Such a lubricant may be used, for example, in place of a lubricant containing molybdenum disulfide. The nanographite may have an average particle size ranging from 0.2 to 50 microns, in some examples ranging from 1 micron to 30 microns, and in one example ranging from 5 microns to 20 microns.

[0028] In another example, a mixture of nanographite and powdered PTFE is used as a second lubricant to lubricate one or more angulation wire(s) of a peroxide-resistant endoscope (e.g., endoscope 100). Such a mixture may be used, for example, in place of a lubricant containing molybdenum disulfide. The nanographite in the mixture may have an average particle size ranging from 0.2 to 50 microns, in some examples from 1 micron to 30 microns, and in one example from 5 microns to 20 microns. The powdered PTFE in the mixture may have an average particle size ranging from 0.1 to 50 microns, in some examples from 1 micron to 30 microns, and in one example from 5 microns to 20 microns.

[0029] Alternatively, the second lubricant may include at least one solid lubricant (e.g., according to either of the examples described in the previous two paragraphs) and may include a small amount (e.g., 15 or 20% by weight or less) of molybdenum disulfide. In one example, the amount of molybdenum disulfide in the second lubricant does not exceed 10% by weight, in another example, the amount of molybdenum disulfide in the second lubricant does not exceed 5% by weight, and in a further example, the amount of molybdenum disulfide in the second lubricant does not exceed 2% by weight.

[0030] Even in the absence of molybdenum disulfide, the strong oxidizing effects of the vaporized hydrogen peroxide atmosphere can degrade endoscope components (e.g., elastomers, adhesives), and free radicals generated by the use of plasma can also degrade components that are otherwise resistant to oxidation by vaporized hydrogen peroxide. Therefore, it may be desirable to implement elastomeric (e.g., rubber) components of endoscope 100 using peroxide-resistant materials.

[0031] In endoscope 100, the outer casing of insertion tube 112 and / or umbilical cord 190 may be made of (e.g., include or consist of) polyurethane, which resists degradation from repeated exposure to an atmosphere of vaporized hydrogen peroxide. While polyurethane is inexpensive and non-reactive, it may not be flexible enough for use in other portions of a peroxide-resistant endoscope, such as the outer casing of curved sections and strain relief boots. It may be desirable to use a peroxide-resistant material that is more flexible than polyurethane for such portions of the endoscope, such as fluorocarbon rubber or silicone rubber.

[0032] In one example, the outer casing of the curved section 118 of the endoscope 100 is made of (e.g., includes or consists of) fluorocarbon rubber. In some examples, the outer casing of the curved section 118 may consist essentially of fluorocarbon rubber, meaning that the outer casing may include additives other than fluorocarbon rubber that do not substantially affect its resistance to VHP or the products of the reaction between molybdenum disulfide and VHP. For example, the fluorocarbon rubber content of the outer casing of the curved section 118 may 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 may be crosslinked in three dimensions.

[0033] Alternatively or additionally, one or more of the strain relief boots of the peroxide-resistant endoscope may be made of (e.g., include or consist of) silicone rubber. For example, one or more of the strain relief boots 132, 134, 172 of the endoscope 100 may be made of silicone rubber. In some examples, one or more strain relief boots may consist essentially of silicone rubber, meaning that one or more strain relief boots may include additives other than silicone rubber that do not substantially affect the resistance to VHP or the reaction products of molybdenum disulfide and VHP. For example, the silicone rubber content of each strain relief boot may 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. Other flexible components of the endoscope 100 that may be made of silicone rubber include the covers for each of the one or more control buttons of the control unit 130 and / or one or more port covers.

[0034] Other components of an endoscope that may degrade (e.g., peel, crack, deform, or discolor) when repeatedly exposed to vaporized hydrogen peroxide may include adhesives and coatings. It may be desirable to implement one or more adhesives or coatings on the endoscope 100 using an epoxy compound. In one example, the adhesive 218 that secures the illumination window 217 to the body 215 of the distal end section 214 is an epoxy adhesive. The epoxy adhesive may be a two-component adhesive including a base resin and a hardener (e.g., a curing agent) and may 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, bisphenol A epoxy resin (e.g., bisphenol A, epichlorohydrin polymer, also known as bisphenol A-type liquid epoxy resin, CAS number 25068-38-6, or Japan ENCS number 7-1283). The hardener may include, for example, polyamidoamine. The weight ratio of the base resin to the hardener in the epoxy adhesive may be greater than 2 to 1, and in some instances may be at least 2.5 to 1, and in some instances may be at least 2.8 or 2.9 to 1. In these or other instances, the weight ratio of the base resin to the hardener in the epoxy adhesive may be 4 to 1 or less, and in some such instances may be 3.5 to 1 or less, and in some such instances may be 3.2 or 3.1 to 1 or less. The curved portion 118 may 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 above). The tip 114 (e.g., tip 214) may be at least partially secured to the curved portion 118 by an epoxy adhesive (e.g., an epoxy adhesive according to any of the examples above).

[0035] In any of these cases, curing the adhesive bond may include maintaining the temperature of the joint where the epoxy adhesive was applied within a cure temperature range for a cure period. The cure temperature range may be, for example, within 1, 2, 5, or 10% of the cure point temperature. In some examples, the cure point temperature may be 75 degrees Celsius, in other examples, the cure point temperature may be 80 degrees Celsius, in other examples, the cure point temperature may be 85 degrees Celsius, and in other examples, the cure point temperature may be 90 degrees Celsius. The cure 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 up to 135 minutes.

[0036] Additionally or alternatively, the adhesive securing 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 above). In some examples, an epoxy coating (e.g., a two-component epoxy adhesive having a weight ratio of base resin to hardener greater than 2, and in some examples, at least 2.5 to 1, and in some examples, at least 2.8 or 2.9 to 1, or 4 to 1 or less, and in some such examples, 3.5 to 1 or less, and in some such examples, 3.2 or 3.1 to 1 or less) may be used to coat the outer surface of the casing of the insertion tube 112 and / or coat the joint (e.g., bond) between the casing of the insertion tube 112 and the curved portion 118.

[0037] Other components of an endoscope that may deteriorate (e.g., peel, crack, deform, or discolor) when repeatedly exposed to vaporized hydrogen peroxide include metal and plastic components. For example, it may be desirable to implement such 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 interface portion 170, one or more ports of control unit 130, and / or body 215 of tip section 214 are made or formed from stainless steel. Additionally or alternatively, interface portion housing 184, the housing of control unit 130, and / or one or more actuators of control unit 130 (e.g., one or more control knobs and / or levers) may be made from (e.g., include or consist of) polyphenylene oxide. In some examples, one or more plastic labels on interface portion 170 and / or control portion 130 (e.g., indicating model number, serial number, instructions, warnings, etc.) may be made of (e.g., may include or consist of) polyolefin and / or PET.

[0038] The principles described herein can be implemented as described to obtain an endoscopic implementation that offers advantages such as resistance to degradation (e.g., no peeling, cracking, deformation, discoloration, or watertight failure) even after multiple cycles of exposure to an atmosphere of vaporized hydrogen peroxide.

[0039] Typically, the process of sterilizing an endoscope by enclosing it in an atmosphere of vaporized hydrogen peroxide, as described above, requires that the cleaned reusable medical device be extremely dry, as residual fluids may interfere with the sterilization process. Therefore, it may be desirable to dry the endoscope after cleaning is complete and before sterilization with vaporized hydrogen peroxide is initiated. Such drying may include gravity-based drying (e.g., in a drying cabinet), as described above, and / or drying by injecting gas into one or more (e.g., all) of the endoscope's lines, as described above (e.g., at a low flow rate and low to moderate temperature, followed by a high flow rate and moderate to high temperature). After drying is complete, the process of sterilizing an endoscope by enclosing it in an atmosphere of vaporized hydrogen peroxide may be performed. No further drying is performed after the sterilization process is complete.

[0040] In some examples, a peroxide-resistant flexible endoscope (e.g., endoscope 100) according to any of the embodiments described herein is reprocessed by performing one or more cleaning processes (e.g., immersion, brushing, wiping, and / or injection of a stream of dispersion liquid described herein, and / or one or more other cleaning processes), followed by one or more HLD processes (e.g., an 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 of the embodiments described herein is reprocessed by performing one or more cleaning processes (e.g., immersion, brushing, wiping, and / or injection of a stream of dispersion liquid described herein, and / or one or more other cleaning processes), followed by one or more sterilization processes (e.g., containing the endoscope in a sterile atmosphere of vaporized hydrogen peroxide and / or one or more other sterilization processes).

[0041] Further exemplary embodiments are provided below.

[0042] Example 1 is an endoscope including an interface portion, a control portion coupled to the interface portion, an insertion portion coupled to the control portion, the insertion portion including a curved portion, an insertion tube extending from a distal end of the control portion to a proximal end of the curved portion, and a tip portion at the distal end of the curved portion, and an optical beam (LCB) extending from the interface portion to the tip portion. In this embodiment, the outer casing of the curved section consists essentially of fluorocarbon rubber, the first lubricant for lubricating the LCB includes at least one solid lubricant and does not contain more than 10% molybdenum disulfide by weight, the outer casing of the insertion tube is bonded to the outer casing of the curved section by a first curing epoxy adhesive, and immediately prior to curing of the first epoxy adhesive, the first epoxy adhesive includes a first base resin component and a first curing agent, and the ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5 (2.5) to 1 by weight.

[0043] Example 2 includes the endoscope according to example 1, wherein the outer casing of the insertion tube includes polyurethane.

[0044] Example 3 includes the endoscope according to any of examples 1 and 2, wherein the at least one solid lubricant of the first lubricant includes a fluorocarbon.

[0045] Example 4 includes the endoscope according to any one of Examples 1 to 3, wherein the first lubricant includes silicone oil.

[0046] Example 5 includes the endoscope according to any one of Examples 1 to 4, wherein the outer casing of the curved portion is joined to the tip portion with a second epoxy adhesive.

[0047] Example 6 includes the endoscope described in any of Examples 1 to 5, wherein the tip portion includes a main body and at least one piece of optical glass, and the at least one piece of optical glass is bonded to the main body by a third epoxy adhesive.

[0048] Example 7 is the endoscope according to Example 6, and the main body of the distal end portion is made of stainless steel.

[0049] Example 8 includes the endoscope of any of Examples 6 and 7, wherein the at least one piece of optical glass is bonded to the LCB.

[0050] Example 9 includes an endoscope according to any of the preceding examples, wherein the endoscope further includes at least one angulation wire extending through the insertion section and configured to transmit force to move the tip section relative to the insertion tube, and wherein the second lubricant lubricating the at least one angulation wire includes at least one solid lubricant and does not include more than 10% molybdenum disulfide by weight.

[0051] Example 10 includes the endoscope of example 9, wherein the at least one solid lubricant of the second lubricant includes nano-graphite.

[0052] Example 11 includes the endoscope according to any of examples 9 and 10, wherein the at least one solid lubricant of the second lubricant includes polytetrafluoroethylene (PTFE).

[0053] Example 12 includes an endoscope according to any of the previous examples, further including a coating covering an exterior surface of the outer casing of the insertion tube and including a flexible epoxy adhesive.

[0054] Example 13 includes an endoscope according to any of the previous examples, further including a strain relief boot joined to the control section and the insertion section and consisting essentially of silicone rubber.

[0055] Example 14 includes an endoscope according to any of the preceding examples, wherein the first lubricant does not include more than 2% molybdenum disulfide by weight.

[0056] Example 15 includes a method of reprocessing an endoscope of any of Examples 1 to 14, the method including exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

[0057] Example 16 includes the method of example 15, further including exposing the interior lumen of the at least one conduit 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.

[0058] Example 17 includes the method of example 16, further including, after exposing the interior lumen of the at least one conduit to at least one of a disinfecting solution and a cleaning solution, drying the endoscope before exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

[0059] Example 18 includes the method of example 15, further including drying the endoscope before exposing the endoscope to the atmosphere containing vaporized hydrogen peroxide.

[0060] Example 19 includes the method of any of examples 17 and 18, wherein drying the endoscope includes suspending the endoscope in a drying cabinet.

[0061] Example 20 includes the method of any of examples 17 and 18, wherein drying the endoscope includes injecting gas into one or more passages of the endoscope.

[0062] Example 21 includes the method of example 20, wherein drying the endoscope includes injecting gas into the one or more conduits at a flow rate in the range of 1 to 20 liters per minute and a temperature in the range of 10 to 30 degrees Celsius, and then injecting gas into the one or more conduits at a flow rate in the range of 20 to 100 liters per minute and a temperature in the range of 30 to 60 degrees Celsius.

[0063] The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to the precise form or embodiment disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. Further, while certain components are described as being coupled to one another, such components may be integrated with one another or distributed in any suitable manner.

[0064] Furthermore, although exemplary embodiments are described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., combinations of aspects across various embodiments), adjustments, and / or variations based on this disclosure. Elements in the claims should be interpreted broadly based on the language used in the claims and not limited to the examples described herein or during prosecution of this application, which examples should be construed as non-exclusive.

[0065] The features and advantages of the present disclosure will be apparent from the detailed specification, and accordingly, the appended claims are intended to cover all systems and methods falling within the true spirit and scope of the present disclosure. As used herein, the indefinite articles "a" and "an" mean "one or more." Similarly, the use of plural terms does not necessarily indicate a plurality unless it is clear in a given context. Words such as "and" or "or" mean "and / or" unless expressly stated otherwise. For purposes of this specification, the phrase "A is based on B" means "A is based on at least B." As used herein, the terms "substantially," "approximately," or "about" can be substituted with "within [a percentage] of" the specified content, where this percentage includes 0.1, 1, 5, and 10 percent. Furthermore, because numerous modifications and variations will readily occur to those skilled in the art upon studying this disclosure, it is not desired to limit the disclosure to the exact structure and operation shown and described; all suitable modifications and equivalents may therefore be resorted to, being within the scope of the present disclosure.

[0066] 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 a true scope and spirit of the disclosed embodiments being indicated by the appended claims.

Claims

1. An endoscope, An interface section; a control unit coupled to the interface unit; an insertion section coupled to the control section, A curved portion and an insertion tube extending from a distal end of the control portion to a proximal end of the curved portion; an insertion portion including a tip portion at a distal end of the curved portion; a light-carrying bundle (LCB) extending from the interface portion to the tip portion; at least one angulation wire extending through the insertion section and configured to transmit a force that moves the tip section relative to the insertion tube; the outer casing of said curved portion consists essentially of fluorocarbon rubber; a first lubricant lubricating the LCB comprising at least one solid lubricant and not containing more than 10% by weight of molybdenum disulfide; a second lubricant lubricating the at least one angulation wire comprises at least one solid lubricant and does not comprise more than 10% by weight of molybdenum disulfide; an outer casing of the insertion tube is bonded to the outer casing of the curved portion with a first epoxy adhesive; Immediately before the first epoxy adhesive is cured, the first epoxy adhesive comprises a first base resin component and a first curing agent; An endoscope, wherein the ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5 (2.5) to 1 by weight.

2. An endoscope, An interface section; a control unit coupled to the interface unit; an insertion section coupled to the control section, A curved portion and an insertion tube extending from a distal end of the control portion to a proximal end of the curved portion; an insertion portion including a tip portion at a distal end of the curved portion; a light-carrying bundle (LCB) extending from the interface portion to the tip portion; the outer casing of said curved portion consists essentially of fluorocarbon rubber; a first lubricant lubricating the LCB comprising at least one solid lubricant and not containing more than 10% by weight of molybdenum disulfide; an outer casing of the insertion tube is bonded to the outer casing of the curved portion with a first epoxy adhesive; a coating film covering an outer surface of the outer casing of the insertion tube and including a flexible epoxy adhesive; Immediately before the first epoxy adhesive is cured, the first epoxy adhesive comprises a first base resin component and a first curing agent; An endoscope, wherein the ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5 (2.5) to 1 by weight.

3. The endoscope of claim 1 or claim 2, wherein the outer casing of the insertion tube comprises polyurethane.

4. 3. The endoscope of claim 1, wherein the at least one solid lubricant of the first lubricant comprises a fluorocarbon.

5. The endoscope according to claim 1 or claim 2, wherein the first lubricant includes silicone oil.

6. 3. The endoscope according to claim 1, wherein the outer casing of the curved portion is bonded to the tip portion by a second epoxy adhesive.

7. the tip includes a body and at least one piece of optical glass; 3. The endoscope of claim 1, wherein the at least one piece of optical glass is bonded to the body by a third epoxy adhesive.

8. The endoscope according to claim 7 , wherein the body of the tip portion is made of stainless steel.

9. The endoscope of claim 1 , wherein the at least one solid lubricant of the second lubricant comprises nano-graphite.

10. The endoscope of claim 1 , wherein the at least one solid lubricant of the second lubricant comprises polytetrafluoroethylene (PTFE).

11. 3. The endoscope of claim 1 or claim 2, wherein the endoscope further comprises a strain relief boot joined to the control section and the insertion section and consisting essentially of silicone rubber.

12. 3. The endoscope according to claim 1, wherein the first lubricant does not contain more than 2% molybdenum disulfide by weight.

13. An endoscope, An interface section; a control unit coupled to the interface unit; an insertion section coupled to the control section, A curved portion and an insertion tube extending from a distal end of the control portion to a proximal end of the curved portion; an insertion portion including a tip portion at a distal end of the curved portion; a light-carrying bundle (LCB) extending from the interface portion to the tip portion; the outer casing of said curved portion consists essentially of fluorocarbon rubber; a first lubricant lubricating the LCB comprising at least one solid lubricant and not containing more than 10% by weight of molybdenum disulfide; an outer casing of the insertion tube is bonded to the outer casing of the curved portion with a first epoxy adhesive; Immediately before the first epoxy adhesive is cured, the first epoxy adhesive comprises a first base resin component and a first curing agent; a ratio of the first base resin component to the first curing agent in the first epoxy adhesive is at least 2.5 (2½) to 1 by weight; the outer casing of the curved portion is bonded to the tip portion with a second epoxy adhesive; An endoscope in which the main body included in the tip portion is formed from stainless steel.

14. 10. A method for reprocessing an endoscope according to claim 1, comprising exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

15. 3. A method for reprocessing an endoscope according to claim 2, including the step of exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

16. 14. A method for reprocessing an endoscope according to claim 13, comprising exposing the endoscope to an atmosphere containing vaporized hydrogen peroxide.

17. an internal lumen of at least one conduit of the endoscope; a disinfectant solution containing at least one high-level disinfectant; or further comprising exposing the cleaning solution to at least one of a detergent or an enzymatic cleaning agent; 17. The method according to any one of claims 14 to 16.

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

19. 17. The method of any one of claims 14 to 16, further comprising the step of drying the endoscope before exposing it to the atmosphere containing vaporized hydrogen peroxide.

20. 20. The method of claim 18, wherein the step of drying the endoscope comprises suspending the endoscope in a drying cabinet.

21. 20. The method of claim 18, wherein the step of drying the endoscope comprises injecting gas into one or more passages of the endoscope.

22. 22. The method of claim 21, wherein the step of drying the endoscope comprises the steps of injecting the gas into the one or more conduits at a flow rate in the range of 1 to 20 liters per minute and a temperature in the range of 10 to 30 degrees Celsius, and thereafter injecting the gas into the one or more conduits at a flow rate in the range of 20 to 100 liters per minute and a temperature in the range of 30 to 60 degrees Celsius.

Images