Channel impregnated with silver ions for an endoscope, an endoscope including the channel impregnated with silver ions, and a method for cleaning and reprocessing such an endoscope

Abstract

The endoscope channel comprises a tube made of polytetrafluoroethylene (PTFE) having at least one additive. The at least one additive contains silver ions and includes a carrier incorporated into the wall of the tube, and the silver ion content in the tube is 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, without limitation, the disclosed embodiments relate to an endoscope channel (e.g., a working channel) impregnated with silver ions, devices and systems having such channels, and methods for manufacturing, assembling, or using such devices, systems, or channels.

Background Art

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

Summary of the Invention

[0003] A channel for an endoscope having a general configuration comprises a tube made of polytetrafluoroethylene (PTFE) having at least one additive. The channel may be at least one of an air channel for an endoscope, a water channel for an endoscope, and a working channel for an endoscope. The at least one additive contains silver ions and includes a carrier incorporated into the wall of the tube, and the silver ion content in the tube is at least 0.0005% by weight of the tube. Also disclosed are an endoscope comprising at least one such channel and a method of reprocessing (e.g., cleaning and / or disinfecting) such an endoscope.

Brief Description of the Drawings

[0004]

Figure 1

Figure 2

Figure 3

Figure 4

Best Mode for Carrying Out the Invention

[0005] The disclosed embodiments include an endoscope including a channel impregnated with silver ions for an endoscope and a channel impregnated with silver ions. Advantageously, the embodiments of the present disclosure suppress the formation of biofilms and enable a long-lasting antibacterial effect that serves as an aid in daily cleaning and disinfection operations.

[0006] As described herein, an endoscope typically includes a control section (e.g., a handle) located at the proximal end, a distal (or “sensing”) end, and an insertion tube extending between the control section and the distal end. The insertion tube houses a tube called a “working channel” that defines an internal lumen. In some cases, the working channel may define two or more internal lumens (e.g., in parallel). The term “proximal” (e.g., “proximal end”) refers to a point or position along the length of the endoscope that is closer to the physician or other medical practitioner during use of the endoscope, and the term “distal” (e.g., “distal end”) refers to a point or position along the length of the endoscope that approaches the position of the tissue to be observed or treated within the patient's body during use of the endoscope. Examples of types of endoscopes include, but are not limited to, bronchoscopes, sinus scopes, nasopharyngoscopes, laryngoscopes, laparoscopes, gastroscopes, duodenoscopes, colonoscopes, hysteroscopes, cystoscopes, ureteroscopes, urethroscopes, cardiac scopes, and arthroscopes.

[0007] FIG. 1 is a diagram showing a part of an endoscope 100. The endoscope 100 includes a control section 130 connected to a distal end 110 by an insertion tube 120. Further, the control section 130 is connected to an interface section 190 via an umbilical cord 180. In this example, the interface section 190 includes an air / water port 140, a suction nipple 150, electrical contacts 160, and / or an optical guide 170. Further, FIG. 1 also shows an example of the configuration of the internal channel of the endoscope 100.

[0008] The working channel of an endoscope may also be referred to as an instrument channel, a tool channel, or a biopsy channel. When using an endoscope, a medical instrument or tool (e.g., forceps, needle, scissors, grasper, retractor, snare, dilator, or brush) can be introduced into the working channel of the endoscope from the proximal end to the distal end (e.g., through the inlet of the working channel) until the distal end of the instrument approaches or reaches a desired position for accessing the patient's tissue or treating the patient's tissue (e.g., performing surgery inside the body, retrieving a tissue sample through the working channel, etc.).

[0009] The diameter of the working channel typically 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 working channel can have an inner diameter (e.g., the inner diameter of the tube of the working channel) in the range of about 1 mm to about 8 mm, in one example about 1 mm to about 5 mm. The inner diameter of the channel can be, for example, at least 3 millimeters, in some examples at least 4 millimeters, and in one example at least 5 millimeters. In other examples, the inner diameter of the channel can be 3 millimeters or less, in some examples 2 millimeters or less, and in one example 1.5 mm or less. More specifically, the working channel can have an inner diameter of about 1.2 mm, about 2.8 mm (e.g., for a gastroscope), about 3.2 mm (e.g., for a colonoscope (34Fr)), about 3.8 mm (e.g., for a colonoscope (38Fr)), or about 4.2 mm (e.g., for a duodenoscope). The inner diameter of the working channel is typically substantially constant along the length of the channel. In endoscopes for gastrointestinal applications (e.g., gastroscopes, duodenoscopes, colonoscopes), the working channel can have a length of up to about 1 meter or 1.5 meters (measured from the working channel inlet located at the control unit to the working channel outlet located at the distal end). The ratio of the inner diameter to the outer diameter of the working channel can be in the range of 0.75 to 0.85.

[0010] When the insertion tube is in a linear configuration (e.g., as shown in FIG. 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 bends (e.g., during use of the endoscope), the working channel bends accordingly, and thus the shape of the working channel may depend on how the endoscope bends. The endoscope may include one or more articulation mechanisms that can be used to bend the insertion tube during use of the endoscope.

[0011] Furthermore, the working channel may be configured to function as a suction channel (e.g., to suction fluid from the body), or the endoscope may include a suction channel separate from the working channel. The endoscope may have two or more working channels.

[0012] The endoscope can include one or more additional channels to provide further functionality. For example, the endoscope can include one or more air channels that can be used to provide a flow of air or carbon dioxide at the distal end (e.g., to improve visibility). In addition to, or alternatively to, this, the endoscope can include one or more water channels that can be used to provide a flow of water at the distal end (e.g., for wound irrigation or lens cleaning). The endoscope may include an air / water combined channel. The inner diameter of the air channel, water channel, or air / water channel of the endoscope can be equal to or similar to (e.g., within a range of 5 or 10 percent) the inner diameter of the working channel of the endoscope, particularly in the case of a particularly small endoscope. In other examples, the inner diameter of the air channel, water channel, or air / water channel of the endoscope can be narrower than the inner diameter of the working channel of the endoscope (e.g., it can be between 10 and 50 percent of the inner diameter of the working channel, and in some examples, it can be as little as 30 percent), particularly in the case of a particularly large endoscope (e.g., an endoscope for gastrointestinal applications). The inner diameter of each such channel is typically substantially constant along the length of the channel. The ratio of the inner diameter to the outer diameter of each such channel can be within a range of 0.7 to 0.8. The length of the air channel, water channel, or air / water channel within the endoscope can be equal to or similar to (e.g., within a range of 5 or 10 percent) the length of the working channel of the endoscope.

[0013] FIG. 2 is a diagram showing an example of the internal channels of the endoscope 200. The endoscope 200 includes a control unit 230 connected to a distal end 210 by an insertion tube 220. The insertion tube 220 houses a working channel 224 that extends between a working channel inlet 232 located in the control unit 230 and a working channel outlet (not labeled) located at the distal end 210. Further, the insertion tube 220 may house an air channel 222 that extends between an air / water supply valve 234 located in the control unit 230 and an air nozzle 214 located at the distal end 210, and / or a water channel 228 that extends between the air / water supply valve 234 located in the control unit 230 and a water nozzle 212 located at the distal end 210. In this example, the endoscope 200 may include, in addition to or instead of these, a water jet channel 226 that extends between a water jet port (not labeled) located in an interface portion (not shown) of the endoscope 200 and a corresponding outlet (not labeled) located at the distal end 210.

[0014] FIG. 3 is a diagram showing another example 300 of the channel of the endoscope. This example includes a working channel 324 extending between a working channel inlet 332 (e.g., located in the control unit of the endoscope) and a working channel outlet (not labeled) located at the distal end 310, a suction control channel 342 extending between the working channel inlet 332 and a suction control valve 336 (e.g., located in the control unit of the endoscope), and a suction supply channel 346 extending between the suction control valve 336 and a suction nipple 350 (e.g., located in the interface unit of the endoscope), showing the components of the working channel and the suction system. FIG. 3 is a schematic diagram, and the relative dimensions of the components shown in this figure are not shown to scale. In the case of a large endoscope (e.g., an endoscope for gastrointestinal applications), the length of the suction supply channel may be equal to or similar to (e.g., within the range of 5 or 10%) the length of the working channel, the length of the suction control channel may be in the range of 80 to 125 millimeters, the inner diameter of the suction supply channel and / or the suction control channel may be within the range of 3 to 5 millimeters (e.g., 3.2, 4.0, and in some examples within the range of 3.2 to 4.0 millimeters), and further / or the ratio of the inner diameter to the outer diameter of the suction supply channel and / or the suction control channel may be within the range of 0.75 to 0.85.

[0015] Figure 4 is a diagram showing another example 400 of the channels of an endoscope. This example shows an air channel 422 extending between an air / water supply valve 434 (located, for example, in the control section of the endoscope) and an air nozzle (not labeled) located at the distal end 410, a water channel 428 extending between the air / water supply valve 434 and a water nozzle (not labeled) located at the distal end 410, an air supply channel 446 extending between the air / water supply valve 434 and an air / water port 440 (located, for example, in the interface section of the endoscope), and also a water supply channel 447 extending between the air / water supply valve 434 and the air / water port 440, showing the components of an air and water channel system. Figure 4 is a schematic diagram, and the relative dimensions of the components shown in this figure are not shown to scale. The length of the air channel and / or water channel of the endoscope may be equal to or similar to (e.g., within a range of 5 or 10 percent) the length of the working channel of the endoscope. In the case of a large endoscope (e.g., an endoscope for gastrointestinal applications), the length of the air supply channel and / or water supply channel may also be equal to or similar to (e.g., within a range of 5 or 10%) the length of the working channel.

[0016] The working channel of the endoscope may be implemented as a tube made of polytetrafluoroethylene (PTFE) that is smooth, durable, and highly non-reactive (e.g., containing PTFE or consisting of PTFE). In addition to this, or alternatively, the inner lumen of the working channel of the endoscope may be lined with a tube made of PTFE. Similarly, the air, water, or air / water channels of the endoscope may be implemented as tubes made of PTFE, and furthermore, or alternatively, their inner lumens may be lined with tubes made of PTFE. Similarly, the suction control channel, suction supply channel, air supply channel, and / or water supply channel of the endoscope may also be implemented as tubes made of PTFE, and furthermore, or alternatively, the inner lumens of such channels may be lined with tubes made of PTFE. In some examples, the tube may be made of different thermoplastic polymers other than PTFE, particularly different fluoropolymers, instead of or in addition to PTFE, for example.

[0017] Since an endoscope is used inside the body, it is expected to be contaminated by such use and must be reprocessed (e.g., washed, disinfected, and / or sterilized) before the next use. Contamination is expected to occur, inter alia, in the working channel, for example, when the instrument or tissue sample after use is removed from the body through the channel, or when fluid is aspirated from the body through the channel. Cleaning of the endoscope can include brushing the working channel and / or passing a detergent or other surfactant and / or a disinfection solution through one, some, or all of air, water, air / water, and / or the working channel. Typically, the air, water, or air / water passages are too narrow to accept a cleaning brush.

[0018] Use and cleaning of the endoscope can cause cumulative microdamage to the working channel. When instruments or tools (typically made of metal) pass through the working channel, they can scratch or wear the inner surface of the channel. Brushing of the channel during cleaning can also increase the surface roughness of the inner surface of the channel. Such microdamage may not affect the usefulness of the endoscope, but over time it may lead to an increased tendency for biofilm formation. A biofilm is formed when bacteria attach to a surface and produce a polymeric matrix that allows further bacteria and other microorganisms to accumulate and form a persistent community. Bacteria within a biofilm are much more resistant to antimicrobial substances than planktonic (free-living) bacteria.

[0019] The risk of biofilm formation can also exist in other channels, such as, for example, air, water, or air / water channels. Such channels may be too narrow to be brushed, and thus, cleaning of the channels is typically performed by passing a cleaning liquid (e.g., a solution containing at least one detergent and / or an enzymatic detergent) through the channels under pressure. Such cleaning techniques may not be effective in removing biofilms or other deposits compared to brushing.

[0020] Cleaning of the endoscopic channel (e.g., any one or more of the endoscopic channels described herein) can include injecting into the internal lumen of the channel a flow in which fine droplets of liquid are dispersed (e.g., suspended) in a gas. The gas may include, for example, one or more of air, nitrogen, or carbon dioxide, or may be essentially composed of these. The liquid may include, for example, one or more of soaked water, distilled water, deionized water, or purified water (e.g., type II laboratory grade purified water), or may be essentially composed of these. In one example, the concentration of surfactant in the liquid does not exceed 2 mg / L. The flow may be turbulent (e.g., may have a Reynolds number greater than 2300, such as in the range of 3500 to 100,000). The flow can be obtained from the output of an atomization chamber. The gas flow rate of the flow may be in the range of 10 to 100 liters per minute. The concentration of droplets in the flow may vary over time (e.g., at a frequency in the range of 3 to 300 cycles per minute). Such a change can be generated, for example, by supplying the gas as a continuous flow to the atomization chamber while supplying the liquid as a pulsed discharge to the atomization chamber. The injection may be performed continuously over a duration in the range of, for example, 60 to 600 seconds.

[0021] After the endoscope is cleaned, a high-level disinfection (HLD) routine can be performed. The HLD routine may include immersing the endoscope in a disinfection solution containing at least one high-level disinfectant. The high-level disinfectant may be configured to eliminate microorganisms (e.g., bacteria) inside or on the surface of the endoscope or a part 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 about 0.2%, such as between 0.1% and 0.3%). After cleaning and / or after HLD, one or more channels of the endoscope (e.g., any one or more of the endoscope channels described herein) can be dried by injecting a gas (e.g., over a duration of 10 to 60 seconds) at a low to moderate temperature (e.g., within the range of 10 to 30 degrees Celsius) at a low flow rate (e.g., within the range of 1 to 20 liters per minute) to remove residual water, and then (e.g., over a duration of 30 to 150 seconds) at a moderate to high temperature (e.g., within the range of 30 to 60 degrees Celsius) at a high flow rate (e.g., within the range of 20 to 100 liters per minute). The gas may include, for example, at least one of nitrogen or air, or may be essentially composed of these. During the high-flow period, the gas may be a plasma (e.g., generated by an electric discharge in a flow of nitrogen or air) that can disinfect the channel. In such a case, the temperature of the plasma may be within the range of 20 to 8 degrees Celsius (e.g., within the range of 30 to 50 degrees Celsius), and the duration of the plasma injection period may be within the range of 5 to 60 seconds.

[0022] In addition to, or instead of, HLD, the endoscope may be confined within a sterilization environment (e.g., vaporized hydrogen peroxide) for a specified period to neutralize biofilm or other contaminants that may remain after cleaning. Such cleaning and HLD and / or sterilization protocols after each such use have been shown to reduce the risk of cross-contamination well below the maximum level permitted by regulation. Nevertheless, it may be desirable to further suppress biofilm formation in a manner that remains effective after a number of use cycles.

[0023] Antimicrobial coatings have been applied to medical devices such as catheters intended for use within the human body. It may be possible to apply an antimicrobial coating to the inner surface of a working channel (and / or one or more other channels of the endoscope), such as the PTFE working channel of the endoscope, but such coatings may not be durable enough to withstand repeated use and cleaning cycles, and their use may lead to peeling or other adhesion failures. Also, the effectiveness of such coatings may decline too rapidly over time to be practical.

[0024] The embodiments disclosed herein relate to an endoscope channel, particularly a working channel, or a liner for an endoscope channel, particularly a working channel, made of a PTFE (or other thermoplastic polymer) tube and incorporating an antibacterial additive (as opposed to, for example, a PTFE tube having an antibacterial coating). The antibacterial additive may be embedded in the substance or material of the channel (or tube), for example, such that some or all of the antibacterial additive is surrounded or encapsulated by the substance or material of the channel, for example, embedded in the wall of the channel. The antibacterial additive can be dispersed or distributed throughout the substance or material of the channel or a portion thereof, for example, uniformly dispersed or distributed, for example, throughout the thickness of the wall of the tube, or over a portion or part of the thickness of the wall of the tube (e.g., at least 1 / 4 of the thickness of the wall of the tube, in some examples at least 1 / 2, in one example at least 3 / 4). It should be noted that the incorporation of the antibacterial additive into the substance of the channel or liner (also referred to herein as "impregnation" of the channel or liner by the additive) is only intended as an auxiliary antibacterial scheme and is not intended to replace the primary disinfection strategy (e.g., HLD). Further embodiments disclosed herein relate to an endoscope channel (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 an endoscope channel, made of a PTFE tube and incorporating an antibacterial additive. Further embodiments disclosed herein include an endoscope made of a PTFE (or other thermoplastic polymer) tube and having one or more channels incorporating an antibacterial additive. Further embodiments disclosed herein are methods of reprocessing (e.g., cleaning and / or disinfecting) and / or sterilizing such an endoscope, including one or more of the cleaning, disinfecting, and / or sterilizing methods described herein and / or any other known methods of cleaning, disinfecting, and / or sterilizing an endoscope.

[0025] The antibacterial additive contains silver ions as an active antibacterial agent and has a substance (the "carrier") that supports the silver ions, and the silver ions can be easily released from the carrier (for example, released in an ion exchange reaction and / or released by melting of the carrier). The carrier can be incorporated into PTFE, for example, before sintering of the PTFE tube (for example, by mixing the powder of the carrier with the PTFE powder prior to extrusion). Therefore, a carrier that can withstand the high temperature of the PTFE sintering process is desirable. 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 exemplary carriers (zeolite and phosphate glass) described below can typically withstand temperatures up to 600 degrees Celsius.

[0026] An example of a suitable carrier is zeolite, which is defined as any one or more of a series of aluminosilicate minerals that are biocompatible and have a microporous structure capable of accommodating silver cations. The amount of silver ions in the zeolite carrier may range from about 0.5 wt% to about 20 wt% of the carrier (for example, in some examples from about 1 wt% to about 10 wt%, in one example from about 2 wt% to about 5 wt%, for example about 2.5 wt%). It is considered that the particle size of the carrier powder affects the rate of release of silver ions from the carrier. The median diameter of the particles in the zeolite carrier may range from about 2 to about 4 microns, and in one example may range from about 2.5 to about 3.5 microns.

[0027] Another example of a suitable carrier is a phosphate glass defined as any one or more of a series of glasses having a biocompatible, glass-forming substrate of phosphorus pentoxide (or its polymorphs) rather than silicon dioxide. Phosphate glasses are bio-soluble materials that can be doped with silver ions and are incorporated into the glass structure rather than being a separate phase, and can thus be used to deliver silver ions in a controlled manner (e.g., depending on the rate of degradation of the glass). The amount of silver ions in the phosphate glass carrier can range from about 0.5 wt% to about 15 wt% of the carrier (in some examples from about 0.5 wt% to about 5 wt%, in one example from about 0.5 wt% to about 2 wt%, e.g., about 0.9 wt%). The median diameter of the particles in the phosphate glass carrier can range from about 10 to about 40 microns, and in one example can range from about 20 to about 30 microns. The desired melting rate (e.g., rate of degradation) of the phosphate glass carrier can be achieved by selecting the composition of the glass by known methods.

[0028] Silver ions can be released from the carrier in an aqueous environment (e.g., when in contact with water or other fluids during use of an endoscope). In the case of a zeolite carrier, such release can occur via an ion exchange reaction. In the case of a phosphate glass carrier, such release can occur via an ion exchange reaction and / or by melting of the carrier.

[0029] As described above, the antibacterial additive may be incorporated into the PTFE as a powder before sintering (e.g., before extrusion). The amount (e.g., content or concentration) of the carrier in the base material of the tube may range from 0.1 to 5 wt% of the base material (e.g., in the range of 0.2 to 2 wt%, or in the range of 0.2 to 1 wt%, or in the range of 0.2 to 0.6 wt%, or about 0.3 wt%, or about 0.4 wt%). The amount of the carrier within the tube (e.g., within the base material of the tube) may be, for example, at least 0.1 wt% of the tube (or the base material), in some examples at least 0.2 wt%, in one example at least 0.5 wt%, and further / or may be, for example, 5 wt% or less of the tube (or the base material), in some examples 2 wt% or less, in one example 1 wt% or less. The amount (e.g., content or concentration) of silver ions within the tube (e.g., within the base material of the tube) may be at least 0.0005 wt% of the tube (5 out of 10,000 parts of 1 wt%), in some examples at least 0.001 wt%, in one example at least 0.002 wt%, in one example at least 0.003 wt%. The amount of silver ions in the carrier may be at least 0.5 wt% of the carrier, in some examples at least 1 wt%, in one example at least 2 wt%, in one example at least 5 wt%, and further / or may be 20 wt% or less of the carrier, in some examples 15 wt% or less, in one example 10 wt% or less, in one example 5 wt% or less. The base material may include virgin PTFE, or the base material may include PTFE modified with one or more fillers and / or other reinforcing agents. The amount of the carrier within the base material may be selected to provide the desired antibacterial effect while maintaining the desired mechanical properties of the resulting PTFE tube, such as the desired flexibility, rigidity, and / or resistance to torsion and crushing.

[0030] By incorporating silver ions into the wall of the tube (rather than, for example, within a coating on the surface of the tube), the resulting antibacterial effect can be expected to have higher durability than when the silver ions are incorporated into a coating applied to the inner surface of the tube. Even minor damage to the inner surface of the channel (which can occur, for example, during use and / or cleaning as described herein) can function to replenish the supply of antibacterial material present on the inner surface of the tube by exposing more of the silver ions incorporated within the wall of the tube to the internal environment of the channel.

[0031] A silver ion-impregnated channel according to the embodiments described herein can be implemented to have an antibacterial effect on the inner surface of the tube that persists (e.g., can be maintained even after a large number (50, 100, 200, etc.) of cleaning cycles) in the use of an endoscope having the channel. Such an antibacterial effect can be expressed as a logarithmic reduction of Escherichia coli of 5.0 or more, 5.5 or more, 6.0 or more, or 6.2 or more (in colony forming units (CFU)), and / or further as a logarithmic reduction of Staphylococcus aureus of 3.0 or more, 3.5 or more, or 3.7 or more (in CFU). The persistence of the antibacterial effect can be expressed as a change of 0.6 or less, 0.8 or less, 1.0 or less, or 1.2 or less in such logarithmic reduction over a predetermined number (e.g., 50, 100, 200) of cleaning cycles. In addition to, or alternatively to, this, a silver ion-impregnated channel according to the embodiments described herein can be implemented to have a high degree of biocompatibility (e.g., a survival rate of at least 95, at least 96, at least 97, or at least 98 percent as determined according to a method for tests regarding cytotoxicity as defined in Annex C of international standard ISO 10993-5).

[0032] In the tests of PTFE tubes where the concentration of the carrier carrying silver ions was 0.6 wt% and 0.9 wt% of the tube, the antibacterial effect on the inner surface of the tube was retained even after 200 cleaning cycles. The antibacterial effect was judged using the method for testing the antibacterial activity of plastics defined in the international standard ISO 22196 (International Organization for Standardization). Specifically, for PTFE tubes where the concentration of the carrier carrying silver ions was 0.6 wt% and 0.9 wt% of the tube, it was revealed that the logarithmic reduction of Escherichia coli (in colony forming units (CFU)) was initially 7.1 and 6.3 after 200 cleaning cycles, and the logarithmic reduction of Staphylococcus aureus (in CFU) was initially 4.3 and 3.7 after 200 cleaning cycles. Furthermore, it was also revealed that such tubes had a high degree of biocompatibility (for example, a survival rate of 98.9% or more determined according to the method for the test regarding cytotoxicity defined in Annex C of the international standard ISO 10993-5).

[0033] The silver ion-impregnated channels according to the embodiments described herein can also be implemented as a liner or as the inner layer of a two-layer tube. A portion of the silver ion-impregnated channel connected to another part of the endoscope (for example, the nozzle or other parts of the insertion portion) may be etched to facilitate agglomerative bonding (for example, adhesion) to such another part of the endoscope. The silver ion-impregnated channel may be wrapped with a wire or reinforced in other ways. The silver ion-impregnated channel may be implemented as an original part of the endoscope or as a retrofit.

[0034] By implementing the principles described herein as described, it is possible to obtain an endoscope with silver ion-impregnated channels and an implementation of an endoscope including one or more silver ion-impregnated channels that provide advantages such as suppression of biofilm formation, provision of a long-lasting antibacterial effect, and / or a role as an auxiliary support function for daily cleaning and disinfection operations.

[0035] Further exemplary embodiments are provided below.

[0036] Example 1 includes a channel for an endoscope, the channel being a working channel and comprising a tube made of polytetrafluoroethylene (PTFE) having at least one additive, the at least one additive containing silver ions and including a carrier incorporated within the wall of the tube, and the silver ion content in the tube being at least 0.0005% by weight of the tube.

[0037] Example 2 includes a channel for an endoscope, the channel comprising a tube made of polytetrafluoroethylene (PTFE) having at least one additive, the channel being at least one of an air channel for an endoscope, a water channel for an endoscope, or a working channel for an endoscope, the at least one additive containing silver ions and including a carrier incorporated within the wall of the tube, and the silver ion content in the tube being at least 0.0005% by weight of the tube.

[0038] Example 3 includes a channel according to Example 1 or 2, wherein the carrier content in the tube is at least 0.1% by weight of the tube and the silver ion content in the carrier is at least 0.5% by weight of the carrier.

[0039] Example 4 includes a channel according to any one of Examples 1 to 3, wherein the carrier content in the tube is 1% by weight or less of the tube.

[0040] Example 5 includes a channel according to any one of Examples 1 to 4, wherein the carrier is dispersed throughout the thickness of the wall of the tube.

[0041] Example 6 includes a channel according to any one of Examples 1 to 5, wherein the carrier is embedded within the wall of the tube.

[0042] Example 7 includes a channel according to any one of Examples 1 to 6, wherein the carrier includes phosphate glass.

[0043] Example 8 includes a channel according to Example 7, wherein the silver ion content in the carrier is 15 wt% or less of the carrier.

[0044] Example 9 includes a channel according to any one of Examples 1 to 8, wherein the carrier includes zeolite.

[0045] Example 10 includes a channel according to Example 9, wherein the silver ion content in the carrier is 20 wt% or less of the carrier.

[0046] Example 11 is a channel according to any one of Examples 1 to 10,

[0047] the tube is made by sintering PTFE,

[0048] and the carrier is incorporated into the PTFE before sintering and includes the channel.

[0049] Example 12 is a channel according to any one of Examples 1 to 11, wherein the inner diameter of the tube is at least 4 millimeters.

[0050] Example 13 is a channel according to any one of Examples 1 to 12, wherein the inner diameter of the tube is 2 millimeters or less.

[0051] Example 14 includes an endoscope having a channel according to any one of Examples 1 to 13 as a working channel.

[0052] Example 15 is a method for cleaning the endoscope of Example 14, including passing a brush through the internal lumen of the working channel.

[0053] Example 16 is the method of Example 15, further including immersing the endoscope in a disinfection solution containing at least one high-level disinfectant.

[0054] Example 17 includes a method according to the method of Example 15 or 16, further comprising exposing the internal lumen of the working channel to vaporized hydrogen peroxide.

[0055] Example 18 includes an endoscope comprising at least one channel according to any of Examples 1 to 13.

[0056] Example 19 is a method of reprocessing the endoscope of Example 18, comprising exposing the internal 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.

[0057] Example 20 is a method of reprocessing the endoscope of Example 19, further comprising exposing the internal lumen of at least one channel to vaporized hydrogen peroxide.

[0058] The above description is presented for purposes 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 a consideration of the specification and practice of the disclosed embodiments. Further, although specific components are described as being coupled to one another, such components may be integrated with one another or dispersed in any suitable manner.

[0059] Furthermore, while 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), adaptations, and / or alterations based on the present disclosure. Elements in the claims are to be broadly construed based on the language employed in the claims and are not limited to the examples described in the specification or presented during the prosecution of the present application, which examples are to be construed as non-exclusive.

[0060] The features and advantages of the present disclosure will be apparent from the detailed description, and accordingly, the appended 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 "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 specifically stated otherwise. For the purposes of this specification, the expression "A is based on B" means that "A is based at least in part on B." As used herein, the terms "substantially," "approximately," or "about" can be replaced by "[a percentage] within the range of" the specified content, and this percentage includes 0.1, 1, 5, and 10 percent. Further, since numerous modifications and variations can be readily envisioned by studying the present disclosure, it is not desirable to limit the present disclosure to the exact structures and operations illustrated and described, and accordingly, reliance can be placed on all suitable modifications and equivalents, which are included within the scope of the present disclosure.

[0061] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. The specification and examples are intended to be considered only as examples, and the true scope and spirit of the disclosed embodiments are indicated by the appended claims.

Claims

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

2. The channel according to claim 1, wherein the channel is a working channel for an endoscope.

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

4. The channel according to claim 1, wherein the content of the carrier in the tube is 1% by weight or less of the tube.

5. The channel according to claim 1, wherein the carrier is dispersed throughout the thickness of the wall of the tube.

6. The channel according to claim 1, wherein the carrier is embedded in the wall of the tube.

7. The channel according to claim 1, wherein the carrier includes phosphate glass.

8. The channel according to claim 7, wherein the content of silver ions in the carrier is 15% by weight or less of the carrier.

9. The channel according to claim 1, wherein the carrier includes zeolite.

10. The content of silver ions in the carrier is 20% by weight or less of the carrier, the channel according to claim 9.

11. The tube is made by sintering PTFE, The carrier is incorporated into the PTFE before the sintering, The channel according to claim 1.

12. The inner diameter of the tube is at least 4 millimeters, the channel according to claim 1.

13. The inner diameter of the tube is 2 millimeters or less, the channel according to claim 1.

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

15. A method of cleaning the endoscope according to claim 14, the method including passing a brush through the inner lumen of the working channel.

16. The method according to claim 15, further including immersing the endoscope in a disinfection solution containing at least one high-level disinfectant.

17. The method according to claim 15, further including 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 the endoscope according to claim 18, A disinfection solution containing at least one high-level disinfectant, or A cleaning solution containing at least one detergent or enzymatic detergent The method including exposing the inner lumen of the at least one channel to at least one of them.

20. The method of reprocessing the endoscope according to claim 19, further including exposing the inner lumen of the at least one channel to vaporized hydrogen peroxide.

Images