Silver ion impregnation channel for endoscope, endoscope comprising silver ion impregnation channel, and method for cleaning and reprocessing such endoscope

Abstract

A channel of an endoscope includes a tube made of polytetrafluoroethylene (PTFE) having at least one additive. The at least one additive includes a carrier containing silver ions and incorporated into the tube wall, the content of silver ions in the tube being at least 0.0005% by weight of the tube.

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 endoscope channels (e.g., working channels) impregnated with silver ions, devices and systems having such channels, and methods of manufacturing, assembling, or using such devices, systems, or channels. Background Art

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

[0003] An endoscope channel according to a general configuration includes a tube made of polytetrafluoroethylene (PTFE) having at least one additive. The channel can be at least one of an air channel of an endoscope, a water channel of an endoscope, or a working channel of an endoscope. The at least one additive includes a carrier containing silver ions and incorporated into the wall of the tube, the silver ions in the tube being at least 0.0005% by weight of the tube. An endoscope including at least one such channel and a method of reprocessing (e.g., cleaning and / or disinfecting) such an endoscope are also disclosed. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1 A diagram of the parts of an endoscope.

[0005] Figure 2 A diagram showing an example of an internal channel of an endoscope.

[0006] Figure 3 A diagram of another example of an endoscope channel.

[0007] Figure 4 A diagram of yet another example of an endoscope channel. DETAILED DESCRIPTION

[0008] The disclosed embodiments include silver ion impregnated channels of endoscopes, and endoscopes including silver ion impregnated channels. Advantageously, the disclosed embodiments allow for a long-lasting antimicrobial effect to inhibit biofilm formation and serve as an adjunct solution to cleaning and disinfection procedures.

[0009] As described herein, an endoscope generally includes a proximal control portion (e.g., a handle), a distal (or "sensing") end, and an insertion tube extending between the control portion and the distal end. The insertion tube contains a tube referred to as a "working channel", which defines an internal lumen. In some cases, the working channel can define more than one internal lumen (e.g., in parallel). The term "proximal" (e.g., "proximal end") refers to a point or position closer to a doctor or other medical practitioner along the length of the endoscope when using an endoscope, and the term "distal" (e.g., "distal end") refers to a point or position closer to the tissue being viewed or treated in the patient's body along the length of the endoscope during 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, hysteroscopes, cystoscopes, urethroscopes, urethroscopes, cardioscopes, and arthroscopes.

[0010] Figure 1 1 is a diagram of the various parts of the endoscope 100. The endoscope 100 includes a control section 130, which is connected to the distal end 110 through the insertion tube 120. The control section 130 is also connected to the interface section 190 via the umbilical cord 180. In this example, the interface section 190 includes an air / water port 140, a suction nozzle 150, an electrical contact 160 and / or a light guide 170. Figure 1 An example of the configuration of the internal channel of the endoscope 100 is also shown.

[0011] The working channel of an endoscope may also be referred to as an instrument channel, a tool channel, or a biopsy channel. During the use of an endoscope, a medical instrument or tool (e.g., forceps, needles, scissors, graspers, retractors, snares, dilators, or brushes) may be introduced from the proximal end of the endoscope (e.g., via the working channel inlet) into the working channel of the endoscope to the distal end of the endoscope until the distal end of the tool approaches or reaches a desired location to enter or treat a patient's tissue (e.g., to perform surgery inside the body, retrieve a tissue sample through the working channel, etc.).

[0012] The diameter of the working channel generally depends on the outer diameter of the endoscope (e.g., the outer diameter of the insertion tube 120). For example, depending on the type of endoscope, the inner diameter of the working channel (e.g., the inner diameter of the tube of the working channel) can range from about 1 mm to about 8 mm, and in one example, about 1 mm to about 5 mm. The inner diameter of the channel can be, for example, at least 3 mm, in some examples at least 4 mm, and in one example at least 5 mm. In other examples, the inner diameter of the channel can be no more than 3 mm, in some examples no more than 2 mm, and in one example no more than 1.5 mm. More specifically, the inner diameter of the working channel can be about 1.2 mm, about 2.8 mm (e.g., for a gastroscope), about 3.2 mm (e.g., for a colonoscope (34 Fr)), about 3.8 mm (e.g., for a colonoscope (38 Fr)), or about 4.2 mm (e.g., for a duodenoscope). The inner diameter of the working channel is generally substantially constant along the length of the channel. In endoscopes for gastrointestinal diseases (e.g., gastroscopes, duodenoscopes, colonoscopes), the length of the working channel can be up to about 1 meter or 1.5 meters (measured from the working channel entrance at the control section to the working channel exit at the distal end). The ratio of the inner diameter to the outer diameter of the working channel can range from 0.75 to 0.85.

[0013] When the insertion tube is in a straight configuration (e.g. Figure 1 ), the working channel extends within the insertion tube such that the longitudinal axis of the working channel is parallel or substantially parallel to the longitudinal axis of the insertion tube. When the insertion tube is bent (e.g., during use of the endoscope), the working channel will also bend accordingly, so that the shape of the working channel may depend on how the endoscope is bent. The endoscope may include one or more articulation mechanisms that can be used to bend the insertion tube during use of the endoscope.

[0014] The working channel may also be configured to function as an aspiration channel (eg, to aspirate fluid from within the body), or the endoscope may include an aspiration channel separate from the working channel. An endoscope may have more than one working channel.

[0015] The endoscope may include one or more additional channels to provide more capabilities. For example, the endoscope may include one or more air channels, which can be used to provide air or carbon dioxide insufflation at the distal end (e.g., for better visibility). In addition or alternatively, the endoscope may include one or more water channels, which can be used to provide water to the distal end (e.g., for irrigating a wound site, for cleaning a lens). The endoscope may include a combined air / water channel. The inner diameter of the air channel, water channel, or air / water channel of the endoscope may be comparable or similar to the inner diameter of the working channel of the endoscope (e.g., within 5% or 10%), particularly for small endoscopes. In other examples, the inner diameter of the air channel, water channel, or air / water channel of the endoscope may be narrower than the inner diameter of the working channel of the endoscope (e.g., may be between 10% and 50%, in some examples as low as 30%), particularly for large endoscopes (e.g., for gastroenterology). The inner diameter of each such channel is generally substantially constant along the length of the channel. The ratio of the inner diameter to the outer diameter of each such channel may range from 0.7 to 0.8. The length of the air channel, water channel, or air / water channel in the endoscope may be comparable or similar (e.g., within 5% or 10%) to the length of the working channel of the endoscope.

[0016] Figure 2 FIG. 2 is a diagram of an example of an internal channel of an endoscope 200. The endoscope 200 includes a control unit 230 connected to the distal end 210 via an insertion tube 220. The insertion tube 220 accommodates a working channel 224 extending between a working channel inlet 232 at the control unit 230 and a working channel outlet (not labeled) at the distal end 210. The insertion tube 220 may also accommodate an air channel 222 extending between an air / water supply valve 234 at the control unit 230 and an air nozzle 214 at the distal end 210 and / or a water channel 228 extending between an air / water supply valve 234 at the control unit 230 and a water nozzle 212 at the distal end 210. In this example, the endoscope 200 may additionally or alternatively further include a water jet channel 226 extending between a water jet port (not labeled) at an interface portion (not shown) of the endoscope 200 and a corresponding outlet port (not labeled) at the distal end 210 .

[0017] Figure 3FIG. 3 is another example of an endoscope channel 300. The example shows a working channel and components of a suction system, including a working channel 324 extending between a working channel inlet 332 (e.g., at a control portion of the endoscope) and a working channel outlet (not labeled) at a distal end 310; a suction control channel 342 extending between the working channel inlet 332 and a suction control valve 336 (e.g., at a control portion of the endoscope); and a suction supply channel 346 extending between the suction control valve 336 and a suction nozzle 350 (e.g., at an interface portion of the endoscope). Figure 3 is a schematic diagram, and the relative sizes of the components shown in the figure are not drawn to scale. For large endoscopes (e.g., for gastroenterology), the length of the suction supply channel can be comparable or similar to the length of the working channel (e.g., within 5% or 10%); the length of the suction control channel can range from 80 mm to 125 mm; the inner diameter of the suction supply channel and / or the suction control channel can range from 3 mm to 5 mm (e.g., 3.2 mm, 4.0 mm, in some examples within the range of 3.2 mm to 4.0 mm); and / or the ratio of the inner diameter to the outer diameter of the suction supply channel and / or the suction control channel can range from 0.75 to 0.85.

[0018] Figure 4 A diagram of another example 400 of endoscope channels. This example shows components of an air and water channel system, including an air channel 422 extending between an air / water supply valve 434 (e.g., at a control portion of the endoscope) and an air nozzle (not labeled) at a distal end 410; a water channel 428, whose channel extends between the air / water supply valve 434 and a water nozzle (not labeled) at the distal end 410; an air supply channel 446 extending between the air / water supply valve 434 and an air / water port 440 (e.g., at an interface portion of the endoscope); and a water supply channel 447, which also extends between the air / water supply valve 434 and the air / water port 440. Figure 4 The diagrams are schematic and the relative sizes of the components shown are not drawn to scale. The length of the air channel and / or water channel of the endoscope can be comparable or similar (e.g., within 5% or 10%) to the length of the working channel of the endoscope. For large endoscopes (e.g., for gastroenterology), the length of the air supply channel and / or water supply channel can also be comparable or similar (e.g., within 5% or 10%) to the length of the working channel.

[0019] The working channel of the endoscope can be implemented as a tube made of polytetrafluoroethylene (PTFE) (e.g., including PTFE or consisting of PTFE), which is smooth, durable and particularly non-reactive. In addition or alternatively, the internal lumen of the working channel of the endoscope can be lined with a tube made of PTFE. Similarly, the air channel, water channel or air / water channel of the endoscope can be implemented as a tube made of PTFE, and / or its internal lumen can be lined with a tube made of PTFE. Similarly, the suction control channel, suction supply channel, air supply channel and / or water supply channel of the endoscope can be implemented as a tube made of PTFE, and / or the internal lumen of such channels can be lined with a tube made of PTFE. In some examples, the tube can be made of a thermoplastic polymer (particularly a different fluoropolymer) different from PTFE (e.g., instead of PTFE or in addition to PTFE).

[0020] Because an endoscope is used within the body, it is expected to become contaminated by such use and must be reprocessed (e.g., cleaned, disinfected, and / or sterilized) before the next use. Contamination may occur, particularly in the working channel: for example, when a used instrument or tissue sample is removed from the body through the channel, or when fluid is aspirated from the body through the channel. Cleaning the endoscope may include brushing the working channel and / or forcing detergents or other surfactants and / or disinfecting solutions through one, some, or all of the air channel, water channel, air / channel water, and / or working channel. Typically, the air channel, water channel, or air / water channel are too narrow to accommodate a cleaning brush.

[0021] Use and cleaning of endoscopes can cause cumulative micro-damage to the working channel. As instruments or tools (often made of metal) are passed through the working channel, they can scratch or abrade the inner surface of the channel. Brushing the channel during cleaning may also increase the surface roughness of the inner surface of the channel. Although this micro-damage may not affect the utility of the endoscope, over time it may lead to an increased tendency for biofilm formation. Biofilms form when bacteria attach to a surface and produce a polymer matrix that enables additional bacteria and other microorganisms to aggregate into persistent communities. Bacteria within biofilms are much more resistant to antimicrobial agents than planktonic (free-living) bacteria.

[0022] There may also be a risk of biofilm formation in other channels (e.g., air channels, water channels, or air / water channels). Such channels may be too narrow to be scrubbed by brushing, so cleaning of the channels is typically performed by forcing a cleaning solution (e.g., a solution containing at least one detergent and / or enzymatic cleaner) through the channels under pressure. This cleaning technique may not be as effective as scrubbing in removing biofilm or other adhesions.

[0023] Cleaning an endoscope channel (e.g., any one or more of the endoscope channels described herein) may include injecting a dispersion (e.g., suspension) stream of fine droplets of liquid in a gas into the inner lumen of the channel. The gas may include or consist primarily of, for example, one or more of air, dinitrogen, or carbon dioxide. The liquid may include or consist primarily 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 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, for example, ranging from 3500 to 100,000). The flow may be obtained from the output of the nebulizer chamber. The gas flow rate of the flow may range from ten liters to one hundred liters per minute. The concentration of droplets in the flow may vary over time (e.g., the frequency ranges from three cycles per minute to three hundred cycles). For example, such a variation may be produced by providing liquid as a pulsed discharge to the nebulizer chamber while providing gas as a continuous flow to the nebulizer chamber. The injection may be performed continuously over a duration of, for example, sixty seconds to six hundred seconds.

[0024] 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. For example, the high-level disinfectant may be configured to eliminate microorganisms (e.g., bacteria) 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), ortho-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%). After cleaning and / or HLD, one or more channels of an endoscope (e.g., any one or more of the endoscope channels described herein) can be dried by injecting gas at a low to moderate temperature (e.g., in the range of 10 degrees Celsius to 30 degrees Celsius) at a low flow rate (e.g., in the range of 1 liter to 20 liters per minute) to remove residual water (e.g., for a duration of 10 seconds to 60 seconds), and then injecting gas at a high flow rate (e.g., in the range of 20 liters to 100 liters per minute) at a moderate to high temperature (e.g., in the range of 30 degrees Celsius to 60 degrees Celsius) (e.g., for a duration of 30 seconds to 150 seconds). The gas can include or consist essentially of, for example, at least one of dinitrogen or air. During the high flow rate, the gas can be a plasma (e.g., generated by an electric discharge in a dinitrogen stream or an air stream), which can sterilize the channel. In this case, the temperature of the plasma can range from 20 degrees Celsius to 8 degrees Celsius (e.g., 30 degrees Celsius to 50 degrees Celsius), and the duration of the plasma injection period can range from 5 seconds to 60 seconds.

[0025] In addition to or as an alternative to HLD, the endoscope can be confined to a sterilizing environment (e.g., vaporized hydrogen peroxide) for a specified period of time to neutralize any biofilm or other contaminants that may remain after cleaning. This means of cleaning and HLD and / or sterilization conditions after each use has been shown to reduce the risk of cross-contamination to well below the maximum levels permitted by regulations. Nevertheless, it may still be desirable to further inhibit biofilm formation in a manner that remains effective after multiple cycles of use.

[0026] Antimicrobial coatings have been applied to medical devices intended for use within the human body, such as catheters. Although antimicrobial coatings can be applied to the interior surface of a working channel (e.g., a PTFE working channel) of an endoscope (and / or one or more other channels of an endoscope), such coatings may not be durable enough to withstand repeated use and cleaning cycles, and their use may result in flaking or other adhesion failures. The efficacy of such coatings may also degrade rapidly over time, making them impractical.

[0027] Embodiments disclosed herein include a channel (particularly a working channel) of an endoscope or a lining of an endoscope channel (particularly a working channel), the lining being made of a PTFE (or another thermoplastic polymer) tube and incorporating an antimicrobial additive (e.g., as opposed to a PTFE tube having an antimicrobial coating). The antimicrobial additive may, for example, be embedded in the substance or material of the channel (or tube), such as embedded in the wall of the channel, such that part or all of the antimicrobial additive is surrounded or enclosed by the substance or material of the channel. The antimicrobial additive may be dispersed or distributed (e.g., uniformly dispersed or distributed) throughout the substance or material of the channel or in a portion thereof, such as the entire wall thickness of the tube or a portion or fraction of the entire wall thickness of the tube (e.g., at least one quarter of the wall thickness of the tube, at least one half in some examples, and at least three quarters in one example). It is noteworthy that incorporating the antimicrobial additive into the substance of the channel or liner (also referred to herein as "impregnating" the channel or liner with the additive) is only an auxiliary antimicrobial solution and is not intended to replace the primary disinfection strategy (e.g., HLD). Other embodiments disclosed herein include a channel of an endoscope (e.g., any of a suction control channel, a suction supply channel, an air channel, a water channel, an air supply channel, a water supply channel, or a water jet channel), or a liner for such a channel in an endoscope, the liner being made of a PTFE tube and incorporating an antimicrobial additive. Other embodiments disclosed herein include an endoscope having one or more channels made of a PTFE (or another thermoplastic polymer) tube and incorporating an antimicrobial additive. Other embodiments disclosed herein include a method for reprocessing (e.g., cleaning and / or disinfecting) and / or sterilizing such an endoscope, the method comprising one or more of the cleaning, disinfecting, and / or sterilizing methods described herein and / or any other known cleaning, disinfecting, and / or sterilizing methods for endoscopes.

[0028] The antimicrobial additive includes silver ions as the active antimicrobial agent and includes a substance ("carrier") that carries the silver ions from which the silver ions can be readily released (e.g., in an ion exchange reaction and / or by melting the carrier). For example, the carrier can be incorporated into the PTFE prior to sintering the PTFE tube (e.g., by mixing a powder of the carrier into the PTFE powder prior to extrusion). Thus, a carrier that can withstand the high temperatures of the PTFE sintering process is desired. The melting temperature of PTFE is 342 degrees Celsius, and it may be desirable to use a carrier that can withstand temperatures up to 400 degrees Celsius. The example carriers described below (zeolites and phosphate glasses) can typically withstand temperatures up to 600 degrees Celsius.

[0029] An example of a suitable carrier is a zeolite, which is defined as any one or more of a class of aluminosilicate minerals that are biocompatible and have a microporous structure that can accommodate silver cations. The amount of silver ions in the zeolite carrier can range from about 0.5% to about 20% by weight of the carrier (e.g., about 1% to about 10% in some examples, about 2% to about 5% in one example, such as about 2.5%). The size of the particles of the carrier powder may affect the rate at which the silver ions are released from the carrier. The median size of the particles in the zeolite carrier can range from about 2 microns to about 4 microns, and in one example about 2.5 microns to about 3.5 microns.

[0030] Another example of a suitable carrier is phosphate glass, which is defined as any one or more of a class of glasses that are biocompatible and have a glass-forming substrate of phosphorus pentoxide (or its polymorphs) rather than silicon dioxide. Phosphate glass is a biosoluble material that can be doped with silver ions, which are incorporated into the glass structure rather than as a separate phase, and can therefore be used to deliver silver ions in a controlled manner (e.g., based on the degradation rate of the glass). The amount of silver ions in the phosphate glass carrier can be in the range of about 0.5% to about 15% by weight of the carrier (in some examples, about 0.5% to about 5%, in one example, about 0.5% to about 2%, such as about 0.9%). The median size of the particles in the phosphate glass carrier can range from about 10 microns to about 40 microns, and in one example, about 20 microns to about 30 microns. The composition of the glass can be selected by known methods to achieve a desired melting rate (e.g., degradation rate) of the phosphate glass carrier.

[0031] Silver ions may be released from the carrier in an aqueous environment (e.g., when in contact with water or other fluids during use of the endoscope). In the case of a zeolite carrier, such release may occur via an ion exchange reaction. In the case of a phosphate glass carrier, such release may occur via an ion exchange reaction and / or by melting the carrier.

[0032] As described above, the antimicrobial additive can be incorporated into the PTFE in powder form before sintering (e.g., before extrusion). The amount (e.g., content or concentration) of the carrier in the substrate of the tube can be in the range of 0.1% to 5% by weight of the substrate (e.g., 0.2% to 2%, or 0.2% to 1%, or 0.2% to 0.6%, or about 0.3%, or about 0.4%). The amount of the carrier in the tube (e.g., in the substrate of the tube) can be, for example, at least 0.1% by weight of the tube (or substrate), at least 0.2% in some examples, at least 0.5% in one example, and / or can be, for example, no more than 5% by weight of the tube (or substrate), no more than 2% in some examples, and no more than 1% in one example. The amount (e.g., content or concentration) of silver ions in the tube (e.g., in the substrate of the tube) can be at least 0.0005% (five ten-thousandths) by weight of the tube, at least 0.001% in some examples, at least 0.002% in one example, and at least 0.003% in one example. The amount of silver ions in the carrier can be at least 0.5% by weight of the carrier, in some examples at least 1%, in one example at least 2%, in one example at least 5%, and / or can be no more than 20% by weight of the carrier, in some examples no more than 15%, in one example no more than 10%, in one example no more than 5%. The substrate can include virgin PTFE, or the substrate can include PTFE modified with one or more fillers and / or other reinforcing agents. The amount of carrier in the substrate can be selected to provide the desired antimicrobial effect while maintaining the desired mechanical properties of the resulting PTFE tube, such as the desired flexibility, stiffness, and / or kink resistance and collapse resistance.

[0033] By incorporating silver ions within the tube wall (e.g., rather than within a coating on the tube surface), it is expected that the resulting antimicrobial effect will have a higher durability than if the silver ions were incorporated into a coating applied to the interior surface of the tube. Micro-damage to the interior surface of the channel (e.g., as may occur during use and / or cleaning as described herein) may even replenish the supply of antimicrobial material present on the interior surface of the tube by exposing more of the silver ions incorporated within the tube wall to the interior environment of the channel.

[0034] Silver ion impregnated channels according to embodiments described herein can be implemented to have an antimicrobial efficacy of the inner surface of the tube that persists during use of an endoscope having the channel (e.g., retained after a large number (50, 100, 200, etc.) of cleaning cycles). This antimicrobial efficacy can be expressed as a log reduction (in colony forming units (CFU)) of not less than 5.0, not less than 5.5, not less than 6.0, or not less than 6.2 for Escherichia coli, and / or a log reduction (in CFU) of not less than 3.0, not less than 3.5, or not less than 3.7 for Staphylococcus aureus. The persistence of the antimicrobial efficacy can be expressed as a change in this log reduction of not more than 0.6, not more than 0.8, not more than 1.0, or not more than 1.2 over a predetermined number (e.g., 50, 100, 200) of cleaning cycles. Additionally or alternatively, the silver ion impregnated channels according to the embodiments described herein can be implemented to have a high degree of biocompatibility (e.g., an activity of at least 95%, at least 96%, at least 97%, or at least 98% as determined by the cytotoxicity test method defined in Annex C of the international standard ISO 10993-5).

[0035] In testing of PTFE tubes, the antimicrobial efficacy of the inner surface of the tubes was maintained after 200 cleaning cycles at carrier concentrations of 0.6% and 0.9% of the tube weight. The antimicrobial efficacy was determined using the test method for antimicrobial activity of plastics defined by the International Standard ISO 22196 (International Organization for Standardization). Specifically, for PTFE tubes with carrier concentrations of 0.6% and 0.9% of the tube weight, the log reduction (in colony forming units (CFU)) of Escherichia coli was found to be 7.1 initially and 6.3 after 200 cleaning cycles, and the log reduction (in CFU) of Staphylococcus aureus was found to be 4.3 initially and 3.7 after 200 cleaning cycles. Such tubes were also found to be highly biocompatible (e.g., activity >= 98.9% as determined by the cytotoxicity test method defined in Annex C of the International Standard ISO 10993-5).

[0036] The silver ion impregnated channel according to the embodiments described herein can also be implemented as an inner layer of a lining or double-layer tube. A portion of the silver ion impregnated channel to be connected to another part of the endoscope (e.g., to other parts of the nozzle or insertion portion) can be etched to facilitate bonding (e.g., gluing) to other such parts of the endoscope. The silver ion impregnated channel can be wrapped with wire or otherwise reinforced. The silver ion impregnated channel can be implemented as an original component of the endoscope or a retrofitted part.

[0037] The principles described herein may be practiced as described to achieve implementations of silver ion impregnated channels of endoscopes and endoscopes comprising one or more silver ion impregnated channels that provide advantages such as inhibiting biofilm formation, providing a long-lasting antimicrobial effect, and / or serving as an auxiliary support feature for cleaning and disinfection procedures.

[0038] Other exemplary embodiments are provided below:

[0039] Example 1 includes a channel of an endoscope, which is a working channel and includes a tube made of polytetrafluoroethylene (PTFE), the tube having at least one additive, wherein: the at least one additive includes a carrier containing silver ions, the carrier is incorporated into the tube wall, and the content of silver ions in the tube is at least 0.0005% by weight of the tube.

[0040] Example 2 includes a channel of an endoscope, the channel including a tube made of polytetrafluoroethylene (PTFE), the tube having at least one additive, wherein: the channel is at least one of an air channel of the endoscope, a water channel of the endoscope, or a working channel of the endoscope; the at least one additive includes a carrier containing silver ions, the carrier is incorporated into the tube wall, and the content of silver ions in the tube is at least 0.0005% of the weight of the tube.

[0041] Example 3 includes a channel according to any one of Examples 1 or 2, wherein: the content of the carrier in the tube is at least 0.1% by weight of the tube; and the content of silver ions in the carrier is at least 0.5% by weight of the carrier.

[0042] Example 4 includes a channel according to any one of Examples 1 to 3, wherein the content of the carrier in the seed tube does not exceed 1% by weight of the tube.

[0043] Example 5 includes a channel according to any of Examples 1 to 4, wherein the carrier is dispersed throughout the wall thickness of the tube.

[0044] Example 6 includes the channel according to any of Examples 1 to 5, wherein the carrier is embedded within the tube wall.

[0045] Example 7 includes the channel of any of Examples 1 to 6, wherein the carrier includes phosphate glass.

[0046] Example 8 includes the channel according to Example 7, wherein the content of silver ions in the carrier does not exceed 15% by weight of the carrier.

[0047] Example 9 includes the channel according to any of Examples 1 to 8, wherein the support includes a zeolite.

[0048] Example 10 includes the channel according to Example 9, wherein the content of silver ions in the carrier does not exceed 20% by weight of the carrier.

[0049] Example 11 includes the channel according to any one of Examples 1 to 10, wherein:

[0050] The tube is made of sintered polytetrafluoroethylene and

[0051] The support is incorporated into the PTFE before sintering.

[0052] Example 12 includes the channel according to any of Examples 1 to 11, wherein the inner diameter of the tube is at least 4 mm.

[0053] Example 13 includes the channel according to any of Examples 1 to 12, wherein the inner diameter of the tube does not exceed 2 mm.

[0054] Example 14 includes an endoscope comprising a channel according to any one of Examples 1 to 13 as a working channel.

[0055] Example 15 includes a method of cleaning the endoscope of Example 14, the method comprising passing a brush through the interior lumen of a working channel.

[0056] Example 16 includes the method of Example 15, further comprising immersing the endoscope in a disinfecting solution comprising at least one high-level disinfectant.

[0057] Example 17 includes the method of any of Examples 15 and 16, further comprising exposing the interior lumen of the working channel to vaporized hydrogen peroxide.

[0058] Example 18 includes an endoscope comprising at least one channel according to any of Examples 1-13.

[0059] Example 19 includes a method of reprocessing the endoscope of Example 18, the method comprising exposing the interior lumen of at least one channel to at least one of a disinfection solution containing at least one high-level disinfectant, or a cleaning solution containing at least one detergent or enzymatic cleaner.

[0060] Example 20 includes a method of reprocessing the endoscope of Example 19, further comprising exposing an interior lumen of at least one channel to vaporized hydrogen peroxide.

[0061] 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 of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. In addition, 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.

[0062] Moreover, although illustrative 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 not limited to the examples described in this specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

[0063] 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 falling within the true spirit and scope of the present disclosure. As used herein, the indefinite articles "one" and "an" mean "one or more". Similarly, the use of plural terms does not necessarily mean plural, unless it is clear in a given context. Unless otherwise clearly 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 based on at least B". As used herein, the term "substantially", "approximately" or "about" can be replaced with "within a specified [percentage]", wherein the percentage includes 0.1%, 1%, 5% and 10%. In addition, since many modifications and variations are easily produced in the study of the present disclosure, it is not expected that the present disclosure will be limited to the exact structure and operation illustrated and described, and thus, all suitable modifications and equivalents falling within the scope of the present disclosure can be adopted.

[0064] 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 following claims.

Claims

1. A channel of an endoscope, comprising a tube made of polytetrafluoroethylene (PTFE), the tube having at least one additive, characterized in that: The channel is at least one of an air channel of the endoscope, a water channel of the endoscope, or a working channel of the endoscope; The at least one additive comprises a carrier containing silver ions and incorporated into the wall of the tube; and The content of silver ions in the tube is at least 0.0005% by weight of the tube.

2. The endoscope channel according to claim 1, characterized in that: The channel is the working channel of the endoscope.

3. The channel of the endoscope according to claim 1, characterized in that The content of the carrier in the tube is at least 0.1% by weight of the tube; and The content of silver ions in the carrier is at least 0.5% by weight of the carrier.

4. The channel of the endoscope according to claim 1, characterized in that The content of the carrier in the tube does not exceed 1% by weight of the tube.

5. The channel of the endoscope according to claim 1, characterized in that: The carrier is dispersed throughout the wall thickness of the tube.

6. The channel of the endoscope according to claim 1, characterized in that: The carrier is embedded in the wall of the tube.

7. The channel of the endoscope according to claim 1, characterized in that: The carrier includes phosphate glass.

8. The channel of the endoscope according to claim 7, characterized in that: The content of silver ions in the carrier does not exceed 15% by weight of the carrier.

9. The channel of the endoscope according to claim 1, characterized in that: The support includes zeolite.

10. The endoscope channel according to claim 9, characterized in that: The content of silver ions in the carrier does not exceed 20% by weight of the carrier.

11. The channel of the endoscope according to claim 1, characterized in that: The tube is made of sintered PTFE, and The support is incorporated into the PTFE prior to sintering.

12. The endoscope channel according to claim 1, characterized in that: The inner diameter of the tube is at least 4 mm.

13. The endoscope channel according to claim 1, characterized in that: The inner diameter of the tube does not exceed 2 mm.

14. An endoscope comprising the channel according to claim 1 as a working channel.

15. A method for cleaning an endoscope as claimed in claim 14, comprising passing a brush through the inner lumen of the working channel. 16 . The method for cleaning an endoscope according to claim 15 , further comprising immersing the endoscope in a disinfection solution containing at least one high-level disinfectant. 17 . The method for cleaning an endoscope according to claim 15 , further comprising exposing the inner lumen of the working channel to vaporized hydrogen peroxide.

18. An endoscope comprising at least one channel according to claim 1.

19. A method of reprocessing an endoscope as claimed in claim 18, the method comprising exposing the interior lumen of at least one of the channels to A disinfectant solution containing at least one high-level disinfectant; or A cleaning solution contains at least one of a detergent or an enzymatic cleaner.

20. A method of reprocessing the endoscope of claim 19, further comprising exposing the interior lumen of at least one of the channels to vaporized hydrogen peroxide.

Images