MXPA06006098A - Endoscope reprocessor connectors having reduced occlusion - Google Patents

Abstract

An occlusion minimizing connector connects a lumen in a lumen device to a source of sterilization fluid in an endoscope reprocessor. The connector has a sealing portion shaped to engage a surface on the lumen device. The sealing portion is formed of a resilient material biasing a sealing surface into contact with the surface on the lumen device. The biasing is such that the seal is maintained when pressure within the flow passage is below a predetermined level preventing leakage of the flow past the sealing portion. When pressure within the flow passage is above the predetermined level fluid leaks past the sealing portion to bathe the surface on the lumen device. Thus, the surface will not be occluded during a cleaning process.

Description

ENDOSCOPE REPROCESSOR CONNECTORS THAT HAVE REDUCED OCCLUSION ANTECEDENTS OF THE TECHNIQUE The present invention relates to endoscope reprocessors and connectors for them. Specifically, to connectors which reduce the insulation between the endoscope and the connector. Endoscopes and similar medical devices that have channels or lumens formed through them are increasingly being used in performing medical procedures. The popularity of these devices has led to demand improvements in the decontamination of these devices between uses, both in terms of the speed of decontamination and the effectiveness of decontamination. A popular method for cleaning and disinfecting or sterilizing said endoscopes employs an automated endoscope reprocessor which washes and subsequently disinfects or sterilizes the endoscope. In general, said unit comprises a tank with a selectively open and closed cover element to provide access to the tank. The pumps are connected to various channels through the endoscope to flow fluid through them and an additional pump makes fluid flow over the outer surfaces of the fluid. endoscope Typically, a wash cycle with detergent is followed by rinsing and then a sterilization or disinfecting and rinsing cycle. Various connections must be made to the endoscope to achieve flow through its channels. The contact between the endoscope and a connector can lead to an occlusion. The typical procedure requires that these surfaces be manually cleaned and carved with sterilization fluid before the connection is made, however, it would be advisable to treat these areas during the reprocessing cycle of the endoscope. The patent of E.U.A. No. 6,041, 794 to Lin et al., Discloses a connector for such use which prevents occlusion. A spring-loaded surface moves away from the connection under increased fluid pressure to provide fluid contact with the surface of the endoscope at the connection point. The patents of E.U.A. Nos. 6,485,684, 6,585,943, 5,795,403 and ,833,935, describe connectors which fit loosely on the endoscope to allow a flow leak beyond the connector.

BRIEF DESCRIPTION OF THE INVENTION A connector according to the present invention connects a lumen in a lumen device with a fluid source in an endoscope reprocessor. The connector comprises a coupling configured to mate with a port connected to the lumen in the lumen, the port includes a first sealing surface. A flow passage passes through the connector. A sealing portion, formed of elastic material, is movably connected to the flow passage and includes a second sealing surface configured to mate with the first sealing surface. The sealing portion is adapted to engage with the first sealing surface under a condition of a first flow in the connector and is further adapted to uncouple from the first sealing surface under a condition of a second flow, different to the first flow, in the connector. When uncoupled, the flow fluid, such as a wash fluid or a disinfecting or sterilizing fluid, can make contact with the first sealing surface in the port. In one aspect of the invention, the elastic material of the sealing portion biases the second sealing surface into contact with the first sealing surface when engaged therewith, the deflection being such that the second sealing surface is sealed against the sealing surface. first sealing surface when the pressure within the flow passage associated with the first flow is below a predetermined level thus preventing leakage of the flow. When the pressure within the flow passage associated with the second flow is above the predetermined level, the second surface is not sealed against the first surface, thus allowing the flow over the first sealing surface. In a different aspect of the invention, the elastic material of the sealing portion biases the second sealing surface away from contact with the first sealing surface when coupled therewith, the deflection being such that the second sealing surface is not seals against the first sealing surface when the pressure within the flow passage associated with the first flow is below a predetermined level thereby allowing flow over the first sealing surface. The sealing portion is oriented such that when the pressure within the flow passage associated with the second flow is above the predetermined level, said pressure pushes the second sealing surface into contact with the first sealing surface thus preventing the leakage of the flow. Preferably, the sealing portion is formed integrally with the connector. The first sealing surface may be cylindrical and the sealing portion comprises an annular flange sized to be positioned against the first sealing surface. Preferably, the sealing portion comprises a free distal edge. A good material for the sealing portion is silicone. Preferably, the first flow is associated with a pressure in the sealing portion of less than 0.84 kg / cm2 gauge and the second flow is associated with a pressure in the sealing portion of greater than 0.84 kg / cm2 gauge. Alternatively, the first flow is associated with a pressure in the sealing portion of greater than 0.35 kg / cm2 gauge and the second flow is associated with a pressure in the sealing portion of less than 0.35 kg / cm2 gauge.

A method according to the present invention connects a port on a lumen device with an endoscope reprocessor and flows fluid through the port. The method comprises the steps of: attaching a coupling in the endoscope reprocessor to the port, the coupling has a flow passage therethrough and a fixed sealing portion movably to the flow passage, the sealing portion can be moving from a first position to a second position, and the sealing portion is formed of an elastic material that deflects it towards one of the first or second position; flowing a first flow through the flow passage and into the port causing the sealing portion to move to the first position; flowing a second different flow through the flow passage causing the sealing portion to move to the second position; and wherein one of the first position and the second position comprises a sealing position in which the sealing portion is sealed against a first sealing surface in the port to prevent the flow from passing, and wherein the other of the first position and the second position comprises a non-sealing position in which the sealing portion is away from the first sealing surface to allow flow over the first sealing surface. In one aspect of the invention, the first position is the sealing position. The sealing portion can be biased towards the first position. In one aspect of the invention, the second flow has a higher pressure than the first flow. This can be created by increasing the volume of the second flow. The highest pressure can be approximately 0.35 to 0.84 kg / cm2 gauge. In another aspect of the invention, the second flow is in a different direction to the first flow. The flows can be from a wash fluid, an antimicrobial agent, or other flows in an endoscope reprocessor.

BRIEF DESCRIPTION OF THE DRAWINGS The invention may take form in various components and arrangements of components and in various steps and arrangements of steps. The drawings are for the sole purpose of illustrating the preferred embodiments, and will not be construed as limiting the invention. Figure 1 is a front elevational view of a decontamination apparatus in accordance with the present invention; Figure 2 is a schematic illustration of the decontamination apparatus shown in Figure 1, showing only a single decontamination tank for clarity purposes; Figure 3 is a fragmentary view of an endoscope suitable for processing in the decontamination apparatus of Figure 1; Figure 4 is a fragmentary view of a connector according to the present invention for connection to the endoscope of Figure 3; Fig. 5 is a fragmentary view of an alternative connector according to the present invention for connection to the endoscope of Fig. 3; Figure 6 is a fragmentary view of an alternative connector according to the present invention for connection to the endoscope of Figure 3; Figure 7 is a fragmentary view of an alternative connector according to the present invention for connection to the endoscope of Figure 3; Fig. 8 is a fragmentary view of a channel connector according to the present invention for use in the endoscope of Fig. 3; Figure 9 is a fragmentary view of a channel connector and spacer according to the present invention for use in the endoscope of Figure 3; Figure 10 is a fragmentary view of an alternative connector according to the present invention for connection to the endoscope of Figure 3; and Figure 11 is a fragmentary view of an alternative connector according to the present invention for connection to the endoscope of Figure 3.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY The figure shows a decontamination apparatus for decontaminating endoscopes and other medical devices which include channels or lumens formed therethrough; Figure 2 shows the apparatus in the form of a block diagram. The decontamination apparatus generally includes a first station 10 and a second station 12 which are at least substantially similar in all respects to provide decontamination of two different medical devices simultaneously or in series. The first and second decontamination reservoirs 14a, 14b receive the contaminated devices. Each reservoir 14a, 14b is selectively sealed by a cap 16a, 16b, respectively, preferably in a microbial blocking relationship to prevent entry of environmental microbes into the reservoirs 14a, 14b during decontamination operations. The covers may include a microbial removal filter or HEPA air filter formed therein for ventilation. A control system 20 includes one or more microcontrollers, such as a programmable logic controller (PLC), for controlling decontamination operations and user interface. Although a control system 20 is shown here controlling both decontamination stations 10, 12, those skilled in the art will recognize that each station 10, 12 may include a dedicated control system. A visual display 22 displays decontamination parameters and machine conditions for an operator and at least one printer 24 prints a legible automatic printed output of the decontamination parameters so that a record is attached or attached to the contaminated device or its storage package. The visual display 22 is preferably combined with a touch-sensitive screen input device. Alternatively, a keyboard or the like is provided for the input of decontamination procedure parameters and for machine control. Other visual calibrators 26 such as pressure gauges and the like provide digital or analog output of decontamination test data or leakage of medical devices. Figure 2 schematically illustrates a station 10 of the decontamination apparatus. Those skilled in the art will recognize that decontamination station 12 is preferably similar in all respects to station 10 illustrated in Fig. 2. However, station 12 has not been shown in Fig. 2 for purposes of clarity. In addition, the decontamination apparatus may be provided with a single decontamination station or with multiple stations. The decontamination reservoir 14a receives an endoscope 200 (see Figure 3) or another device therein for decontamination. Any internal channel of endoscope 200 is connected to discharge lines 30. Each discharge line 30 is connected to an outlet of a pump 32. Pumps 32 are preferably peristaltic pumps or the like which pump fluid, such as liquid or air, to through the discharge lines 30 and any internal channel of the medical device. Specifically, the pumps 32 can either withdraw liquid from the reservoir 14a through a filtered drain 34 and a first valve S1, or can extract decontaminated air from an air supply system 36 through a valve S2. The air supply system 36 includes a pump 38 and an air filter for removing microbes 40 that filters microbes that come from an incoming air stream. It is preferable that each discharge line 30 be provided with a dedicated pump 32 to ensure adequate fluid pressure and facilitate the individual monitoring of the fluid pressure in each discharge line 30. A pressure switch or sensor 42 is in communication of fluid with each discharge line 30 to detect excessive pressure in the discharge line. Any detected excessive pressure indicates a partial or complete blockage, for example, by body tissue or dry bodily fluids, in a channel of the device to which the relevant discharge line is connected. The isolation of each discharge line 30 with respect to the other allows the particular blocked channel to be easily identified and isolated, depending on which sensor 42 detects the excessive pressure. The reservoir 14a is in fluid communication with a water source 50 such as a tap or service water connection that includes hot and cold water inlets and a mixing valve 52 which flows into a rupture tank 56. A filter for removal of microbes 54, such as a filter with an absolute pore size of 0.2 μm or smaller, decontaminates the incoming water which is supplied to the rupture tank 56 through the air space to prevent reflux. A pressure type level sensor 59 monitors the liquid levels within the reservoir 14a. An optional water heater 53 can be provided if an adequate source of hot water is not available. The condition of the filter 54 can be monitored by directly monitoring the flow rate of the water through it or indirectly by monitoring the tank fill time using a floating switch or the like. When the flow rate falls below a selected threshold, this indicates a partially clogged filter element that requires replacement. A reservoir drain 62 drains fluid from the reservoir 14a through an elongated helical tube 64 into which elongated portions of the endoscope 200 can be inserted. The drain 62 is in fluid communication with a recirculation pump 70 and a drainage pump 72. The recirculation pump 70 recirculates liquid from the reservoir drain 62 to a spray nozzle assembly 60 which sprinkles the liquid to the reservoir 14a and to the endoscope 200. The coarse and fine sieves 71 and 73, respectively, filter particles into the reservoir. the recirculation fluid. The drain pump 72 pumps liquid from the reservoir drain 62 to a service drain 74. A level sensor 76 monitors the liquid flow from the pump 72 to the utility drain 74. The pumps 70 and 72 can be simultaneously operated so that the liquid is sprayed into the reservoir 14a while it is drained to cause the flow of residue out of the reservoir and out of the device. Of course, a simple pump and a valve assembly can replace the double pumps 70, 72. An in-line heater 80, with temperature sensors 82, downstream of the recirculation pump 70 heats the liquid at optimum temperatures for cleaning and disinfection . A switch or pressure sensor 84 measures the downstream pressure of the circulation pump 70. The detergent solution 86 is measured in the upstream flow of the circulation pump 70 through a metering pump 88. A float switch 90 indicates the level of detergent available. As a rule, only a small amount of disinfectant 92 is required. To more accurately measure this, an assortment pump 94 fills a pre-chamber 96 under control of a high / low level switch 98 and, of course, the system control 20. A measuring pump 100 measures a precise amount of disinfectant as needed. Endoscopes and other reusable medical devices often include a flexible outer housing or shell that surrounds the individual tubular elements and the like that form the inner channels and other parts of the device. This housing defines a closed interior space, which is isolated from the tissues and fluids of the patient during medical procedures. It is important that the cover remains intact, without cuts or other holes that allow contamination of the interior space under the cover. Therefore, the decontamination apparatus includes means for testing the integrity of said cover. An air pump, either the pump 38 or another pump 110, pressurizes the interior space defined by the cover of the device through a conduit 112 and a valve S5. Preferably, a microbial removal filter or HEPA 113 air filter removes microbes from the pressurizing air. An overpressure switch 114 prevents accidental overpressure of the cover. After total pressurization, the valve S5 closes and a pressure sensor 116 seeks a decrease in pressure in the conduit 112 which would indicate the escape of air through the cover. A valve S6 selectively vents the conduit 112 and the cover through an optional filter 118 when the test procedure is completed. An air damper 120 equals the pressure pulsation of the air pump 110. Preferably, each station 10 and 12 contain a drip reservoir 130 and a spill sensor 132 to alert the operator to potential leaks. An alcohol supply 134 controlled by an S3 valve can supply alcohol to the pumps of the channel 32 after the rinsing steps to help remove water from the channels of the endoscope. The flow rates in the supply lines 30 can be monitored through the channel 32 pumps and the pressure sensors 42. The channel pumps 32 are peristaltic pumps which provide a constant flow. If one of the pressure sensors 42 detects a too high pressure, the associated pump 32 is out of cycle. The flow rate of the pump 32 and its percentage in time provide a reasonable indication of the flow velocity in an associated line 30. These flow rates are monitored during the procedure to verify blockages in any of the endoscope channels. Alternatively, the drop in pressure from the moment the pump 32 is out of cycle can also be used to estimate the flow velocity, with faster decay rates associated with higher flow rates. A more accurate measurement of flow velocity in a single channel may be advisable to detect more subtle blockages. A measuring tube 136 having a plurality of level indicating sensors 138 is fluidly connected to the inputs of the channel pumps 32. A preferred sensor arrangement provides a reference connection at a low point in the measuring tube and a plurality of sensors 138 arranged vertically thereon. By passing a current from the reference point through the fluid to the sensors 138, it can be determined which sensors 138 are submerged and therefore determine the level within the measuring tube 136. Other level detection techniques can also be applied. When the valve S1 is closed and an S7 ventilation valve is opened, the channel pumps 32 extract exclusively from the measuring tube. The amount of fluid that is extracted can be determined very precisely based on the sensors 138. When running each channel pump in isolation, the flow between them can be determined accurately based on time and volume of fluid emptied from the measuring tube. In addition to the input and output devices described above, all electrical and electromechanical devices shown are operatively connected to and controlled by the control system 20. Specifically, and without limit, the switches and sensors 42, 59, 76, 84, 90, 98, 114, 116, 132 and 136 provide input I to microcontroller 28 which controls the decontamination and other operations of the machine in accordance therewith. For example, microcontroller 28 includes outputs O that are operatively connected to pumps 32, 38, 70, 72, 88, 94, 100, 110, valves S1-S7, and heater 80 to control these devices for effective decontamination. and other operations. Further referring to Figure 3, an endoscope 200 has an upper portion 202, in which openings 204 and 206 are formed, and in which, during normal use of the endoscope 200, an air / water valve and a valve are disposed. of suction. A flexible insertion tube 208 is fixed to the upper part 202, which tube accommodates a combined air / water channel 210 and a combined suction / biopsy channel 212. A separate air channel 213 and water channel 214, which at the location of a junction 216 are fused in air / water channel 210, are disposed at the top 202. In addition, a separate suction channel 217 and biopsy channel 218, which at the location from the junction 220 are fused in the suction / biopsy channel 212, are accommodated in the upper part 202. In the upper part 202, the air channel 213 and the water channel 214 open towards the opening 204 for the valve of air / water. The suction channel 217 opens towards the opening 206 for the suction valve. In addition, a flexible feed hose 222 connects to the top 202 and accommodates the channels 213 ', 214', and 217 'which through the openings 204 and 206, are connected to the air channel 213, to the air channel. water 214 and suction channel 217, respectively. In practice, the supply hose 222 is also referred to as the housing of the light conductor. The mutually connecting channels 213 and 213 ', 214 and 214', 217 and 217 'will be referred to below in a general manner, such as the air channel 213, the water channel 214 and the suction channel 217. A connection 226 for the air channel 213, connections 228 and 228a for the water channel 214 and a connection 230 for the suction channel 217 are arranged in the end section 224 (also referred to as the light conductor connector) of the flexible hose 222 When connection 226 is in use, connection 228a is closed. A connection 232 for the biopsy channel 218 is disposed at the top 202. A channel separator 240 is shown inserted into the openings 204 and 206. It comprises a body 242, and plug elements 244 and 246 which respectively occlude the openings 204 and 206. A coaxial insert 248 in the plug member 244 extends into the opening 204 and terminates in an annular flange 250 which occludes a portion of the opening 204 to separate the channel 213 from the channel 214. When connecting the lines 30 with the openings 226, 228, 228a, 230 and 232, the cleaning and disinfecting liquid can flow through the endoscope channels 213, 214, 217 and 218 and out of a distal tip 252 of the endoscope 200 through the channels 210 and 212. The channel separator 240 ensures that said liquid flows through the endoscope 200 without leakage through the openings 204 and 206 and isolates the channels 213 and 214 from each other so that each has its own independent flow path ndiente. One skilled in the art will appreciate that various endoscopes having different channel and aperture arrangements will likely require modifications to the channel separator 240 to accommodate such differences and at the same time occlude ports in the upper portion 202 and keep the channels spaced apart from each other to that each channel can be downloaded independently of the other channels. Otherwise, a block in a channel can simply redirect the flow to an unblocked channel connected. A leak port 254 in the end section 224 leads to an inner portion 256 of the endoscope 200 and is used to verify the physical integrity thereof, especially to ensure that no leakage has formed between any of the channels and the interior 256 or from the outside to the inside 256.

The proper connection to the various channels of the endoscope is necessary to ensure its proper cleaning and sterilization. The connections are made with a connection assembly (not shown) comprising a set of flexible tubes of which one end is connected to ports in the endoscope reprocessor associated with the pumps of channel 32. The other end has a connector adapted to be coupled with a connection in the endoscope 200. Since endoscopes vary by manufacturer and model, different connection kits are usually provided to fit different endoscopes. Figure 4 shows a connector 300 for connecting to a connection 228 (see also figure 3) in the endoscope 200. A tubular body 302 terminates in a seal 304. The body and seal 302 and 304 are formed of an elastic material such as silicone or plastic or elastic polymer. Body 302 can be formed of a material other than seal 304 and more than elastic, it can be rigid. The seal 304 is bent inward, and the curve continues until it finally widens outwardly. Preferably, its thickness decreases as it continues to widen away from the body 302. The pins 308 extend radially outwardly from the body 302. Preferably, the pins 308 are molded with the body 302. They are attached to spring clips 310 which they are fixed to a stop 312 in the endoscope 200 adjacent to the connection 228. There are two flow paths through! connector 300. A first flow path 314 occurs under low pressure. The seal 304 engages the connection 228 and prevents the fluid from escaping. Therefore, the flow enters the connection 228. A second flow path 316 occurs under higher pressures. When the pressure exceeds the coupling force of seal 304, fluid leaks past seal 304 and bathes an external surface 318 of connection 228. Spring clips 310 prevent connector 300 from detaching from connection 228. pressure under which seal 304 moves away from its contact with a surface at connection 228 depends on the size of the connection. For a large connection, a pressure of 0.70 to 0.70 kg / cm2 gauge could be adequate, while for a smaller connection a pressure of approximately 0.35 kg / cm2 gauge would suffice. Pressures greater than approximately 1.47 kg / cm2 gauge may exceed the maximum recommended pressure for most endoscopes. Referring now to Figure 5, some connections in the endoscope 200, such as the water channel connection 228a, end in an annular flange 320. A connector 322 is connected to said connection 228a. The connector 322 comprises a cylindrical body 324 having an expanded diameter section 326, preferably with a taper 328. A distal portion 330 of the expanded diameter section 326 extends internally radially to form a mating surface 332 which rests on flange 320 to hold connector 322 on connection 228a. The body 324 extends distally from the expanded diameter section 326 and terminates in a seal 334 similar to the seal 304. A low pressure flow path 336 passes through the connector 322 and into the connection 228a, with the seal 334 preventing the leakage. Under conditions of higher pressure, a second flow path 338 opens as the seal 334 disengages from the connection 228a. Referring further to Figure 6, other connections in the endoscope 200, such as the connection 230, are in the form of a hose tab 340. A connector 342 engages the hose tab 340 on the connection 230. The connector 342 it comprises a cylindrical body 344 having an internal diameter slightly larger than the wider diameter of the hose tongue 340. The body 344 terminates in a seal 346. The seal 346 engages the connection 230 proximally of the hose tongue 340 and operates as in the two previous modalities. further, engages with the hose tab 340 to prevent connector 342 from decoupling from connection 230. Therefore, a low pressure flow path 348 passes through connector 342 and into connection 230 and a flow path Higher pressure 350 passes between the hose tab 340 and the body 344 and beyond the seal 346. Referring now to Figure 7, some connections in the endoscope 200 comprise one or more outwardly extending annular flanges 352 as in the connection 232. A connector 354 is connected to the connection 232. The connector 354 comprises a body 356 which expands outwards 358 towards a section of expanded diameter 360 which improves the access of fluids to the flanges 352. expanded diameter section 360 terminates distally with an inwardly extending annular flange 362. A seal 364 extends inward toward the expanded diameter section 360 from the widening 358. Flange 362 on connector 354 engages flange 352 on connection 232 to hold connector 354 on connection 232. A first flow path 366 passes from connector 354 to connection 232. This flow path will remain even low higher pressures due to the direction in which the seal 364 widens from the body 356. Rather than providing a second flow path when changing the pressure, here, the flow is reversed to provide an inverted flow path 368. These parts they are immersed in the same liquid that flows through the connector 354 so that when the flow is reversed, a portion of the fluid surrounding the connector 354 is drawn into the connector 354 beyond the seal 364 thereby contacting the surfaces remaining at connection 232. A second seal (not shown) may be provided at connector 354 on flange 362 and may be oriented to allow reverse flow. The channel connector 240 provides another possible source of occlusion. Figures 8 and 9 show an alternative of non-occlusion. Rather than being formed as a one-piece unit such as the channel separator 240, it comprises an air / water valve channel connector 370 for insertion into the opening 204 for the air / water valve and a channel separator and connector. suction valve 374 for insertion in opening 206 for the suction valve. A one-piece unit could also work. The air / water valve channel connector 370 comprises a cylindrical body 376 open at a distal end 378 thereof. A seal 380 is located at distal end 378 and extends toward the interior surface of opening 204.

Unlike seals in the above embodiments, this seal 308 is smaller in circumference when relaxed than the circumference of opening 204 and therefore at the beginning is out of engagement with surface 204. A proximal end 382 of body 376 is closed and extends radially outwardly, downwardly and inwardly to form an annular rim 383 which engages an outwardly extending annular flange 384 around the opening 204. In normal operation, the fluid will flow through the channel 217 'beyond the seal 308 by bathing the surfaces of the opening 204. The fluid can also enter through the opening 204 since these parts are immersed in fluid. As the flow increases, it pushes the seal 308 against the surface of the opening 204, as illustrated in FIG. 8. The fluid subsequently flows out through the suction channel 217. The valve channel connector and separator suction 374 comprises a body 386 having a proximal end construction similar to the air / water valve channel connector 370 that is closed and terminates in a flange 388 for engagement with a flange 390 around the opening 206. At one end distal 392 of body 386, a first seal 394 extends distally outwardly and a second seal 396 extends outward and proximally. The seals 394 and 396 are disposed within the opening 206 outward from where the channel 214 'and the water channel 214 coincide with the opening 206. A third seal 398 widens outward and distally from the body 386 and is arranged outwardly from where the channel 213 'and the air channel 213 intersect the opening 206. As with the channel connector 370, the seals 394, 396 and 398 do not engage with the surface of the opening 206 when they are relaxed . These expand as fluid flows into opening 206 from lines 213 'and 214'. Figure 10 illustrates a further concept of a non-occlusion connector 400 in accordance with the present invention. Similar to connector 300 of Figure 4, connector 400 comprises a body 402 and a seal 404 held in connection 228 by spring clips 406 connected to body 402 by pins 408. Body 402 is annular, with an internal diameter exceeding the external diameter of the connection 228, and the seal 404 is formed by the body 402 tapering distally to a smaller diameter sufficient to couple the connection 228. Preferably, the seal 404 also thins distally. A first flow path 410 passes through the connection 228 and with increasing pressure, as from an increment flow, the seal 404 separates from the connection 228 to create a second flow path 412 beyond the 404 seal and bathing the remainder of the outer surface of the connection 228. Figure 11 illustrates an additional connector 420 for the connection 228. It has an annular body 422, with pins 424 and fasteners 426 for attachment to the connection 228. The body 422 terminates in a distal seal 428 similar to the seal 404. However, the body 422 and especially the seal 428 have a smaller diameter compared to the previous embodiment. The seal 428 terminates in a smaller diameter than an internal diameter of the connection 428 and is placed therein. Under lower flows the fluid passes between the seal 428 and the connection 228 as shown in Figure 11. Under stronger pressure, such as from an increased flow through the connector 420, the seal 428 expands to couple the connection 228 and then direct the entire flow through it. The cleaning and sterilization cycle in detail comprises the following steps.

Step 1. Open the lid Pressing a pedal (not shown) opens the lid of the tank 16a. There is a separate pedal for each side. If the pedal pressure is removed, the movement of the lid stops.

Step 2. Position and connect the endoscope The insertion tube 208 of the endoscope 200 is inserted into the helical circulation tube 64. The end section 224 and the upper section 202 of the endoscope 200 are located within the reservoir 14a, with the feeding hose 222 wound inside the reservoir 14a with a diameter as wide as possible.

The discharge lines 30, preferably with color code, are joined, one for each, to the openings of the endoscope 226, 228, 228a, 230 and 232. Air line 112 is also connected to connector 254. A guide located in station 10 provides a reference for color-coded connections.

Step 3. Identify the user, the endoscope, and the specialist for the system Depending on the configuration selectable by the client, the control system 20 may suggest the user code, the patient ID, the endoscope code, and / or the specialist's code. This information may be entered manually (via the touch-sensitive screen) or automatically such as by the use of an optical bar-coded detector (not shown).

Step 4. Close the reservoir cap Closing the cap 16a preferably requires the user to simultaneously press a hardware button and a button 22 of the touch screen (not shown) to provide a fail-safe mechanism to prevent hands of the user are grasped or tightened when closing the reservoir lid 16a. If the hardware button or the software button is released while the lid 16a is in the closing procedure the movement will stop.

Step 5. Start program The user presses a button 22 of the touch screen to start the washing / disinfection procedure.

Step 6. Pressurize the endoscope body and measure the leak rate The air pump starts and the pressure inside the endoscope body is monitored. When the pressure reaches 250 mbar, the pump is stopped, and the pressure is allowed to stabilize for 6 seconds. If the pressure does not reach 250 mbar in 45 seconds the program stops and the user is notified of the leak. If the pressure falls below 100 mbar during the stabilization period of 6 seconds, the program stops and the user is notified of the condition. Once the pressure has stabilized, the pressure drop is monitored in the course of 60 seconds. If the pressure drops more than 10 mbar in 60 seconds, the program is stopped and the user is notified of the condition. If the pressure drop is less than 10 mbar in 60 seconds, the system continues with the next step. A slightly positive pressure is maintained within the body of the endoscope for the remainder of the procedure to prevent the fluids from leaking internally.

Step 7. Verify connections A second leak test verifies the connection sufficiency for the various ports 226, 228, 228a, 230, 232 and the proper placement of the channel separator 240. A quantity of water is admitted to the reservoir 14a in order of immersing the distal end of the endoscope in the helical tube 64. The valve S1 closes and the valve S7 opens and the pumps 32 are run in the reverse direction to extract a vacuum and to finally remove the liquid in the channels of the endoscope 210 and 212. The pressure sensors 42 can be monitored to ensure that the pressure in any channel does not fall more than a predetermined amount in a given time frame. If it does, this probably indicates that one of the connections was not made correctly and the air will escape in the channel. In any case, in the presence of an unacceptable pressure drop, the control system 20 will cancel the cycle and indicate a probably faulty connection, preferably with an indication of which channel is failing. The volume of liquid that is withdrawn in the measuring tube 136 in a given amount of time is measured and compared against a known standard for the model and channel of the particular endoscope. If the volume varies from the standard amount this will indicate a failure. If the connection to port 226, etc., is not hermetic, the air will leak internally and sufficient volume will be prevented from entering the measuring tube 136. Similarly, an obstruction within the endoscope channel will prevent sufficient volume from entering the tube. measurement 136.

Pre-rinse The purpose of this step is to discharge water through the channels to remove residual material before washing and disinfecting the endoscope 200.

Step 8. Fill reservoir The reservoir 14a is filled with filtered water and the water level is detected by the pressure sensor 59 below the reservoir 14a.

Step 9. Pump water through the channels Water is pumped via pumps 32 through the interior of channels 213, 214, 217, 218, 210 and 212 directly to drain 74. This water is not recirculated around the surfaces of the endoscope 200 during this stage.

Step 10. Drain As the water is pumped through the channels, the drain pump 72 is activated to ensure that the reservoir 14a is also emptied. The drain pump 72 will be turned off when the drain switch 76 detects that the drain procedure is complete.

Step 11. Blow air through the channels During the draining procedure, sterile air is blown through the air pump 38 through all the channels of the endoscope simultaneously to minimize the potential remnant.

Washed Step 12. Fill the tank The tank 14a is filled with hot water (35 ° C). The temperature of the water is controlled by controlling the mixing of heated and unheated water. The water level is detected by the pressure sensor 59.

Step 13. Add detergent The system adds enzymatic detergent to the water circulating in the system by means of the peristaltic measuring pump 88. The volume is controlled by controlling the assortment time, the pump speed, and the inside diameter of the pump. peristaltic pump tube.

Step 14. Circulating the wash solution The detergent solution is actively pumped through the internal channels and onto the surface of the endoscope 200 for a predetermined period, typically from one to five minutes, preferably around three minutes, by the pumps of the channel 32 and the external circulation pump 70. The in-line heater 80 maintains the temperature at approximately 35 ° C.

Step 15. Start blogging test After the detergent solution has been circulated for a couple of minutes, the flow rate through the channels is measured. If the flow rate through the channels is less than a predetermined speed for that channel, the channel is identified as blocked, the program is stopped, and the user is notified of the condition. The peristaltic pumps 32 are run at their predetermined flow rates and out of cycle in the presence of unacceptable high pressure readings in the associated pressure sensor 42. If a channel is blocked the predetermined flow rate will trigger the pressure sensor 42 indicating the inability to adequately pass this flow velocity. Since the pumps are peristaltic, their operating flow rate combined with the percentage of time out of cycle due to pressure, will provide the current flow rate. The flow rate can also be estimated based on the pressure drop from the moment the pump 32 is out of cycle.

Step 16. Drain The drain pump 72 is activated to remove the detergent solution from the reservoir 14a and the channels. The drain pump 72 is turned off when the drain level sensor 76 indicates that the drain is complete.

Step 17. Blow air During the sterile air drainage procedure is blown through all the channels of the endoscope simultaneously to minimize the potential remnant.

Rinse Step 18 Fill the tank The tank 14a is filled with hot water (35 ° C). The temperature of the water is controlled by controlling the mixing of hot and unheated water. The water level is detected by the pressure sensor 59.

Step 19. Rinsing The rinse water is circulated within the channels of the endoscope (by means of the pumps of the channel 32) and on the outside of the endoscope 200 (by means of the circulation pump 70 and the spray arm 60) during 1 minute.

Step 20. Continue the blogging test As the rinse water is pumped through the channels, the flow rate through the channels is measured and if it falls below the predetermined speed for any given channel, the channel is identified as blocked, the program is stopped, and the user is notified of the condition.

Step 21. Drain. The drain pump is activated to remove the rinse water from the tank and the channels.

Step 22. Blow air During the draining procedure, sterile air is blown through all the channels of the endoscope simultaneously to minimize potential remnants.

Step 23. Repeat rinsing Steps 18 through 22 are repeated to ensure maximum rinse of the enzymatic detergent solution from the surfaces of the endoscope and reservoir.

Disinfect Step 24. Fill the tank The tank 14a is filled with very hot water (53 ° C). The temperature of the water is controlled by controlling the mixture of hot and unheated water. The water level is detected by the pressure sensor 59. During the filling process, the pumps of the channel 32 are turned off to ensure that the disinfectant in the tank is in the concentration in use before circulating through the channels .

Step 25. Add disinfectant A measured volume of disinfectant 92, preferably CIDEX OPA ortho -lallaldehyde concentrated solution, available from Advanced Sterilization Products Division Ethicon, Inc., Irvine, CA, is drawn from disinfectant measuring tube 96 and supplied in the water in the reservoir 14a by means of the measuring pump 100. The volume of disinfectant is controlled by the positioning of the filling sensor 98 relative to the lower part of the assortment tube. The measuring tube 96 is filled until the upper level switch detects liquid. The disinfectant 92 is removed from the measuring tube 96 until the level of the disinfectant in the measuring tube is just below the tip of the collection tube. After the necessary volume is supplied, the measuring tube 96 is refilled from the disinfectant bottle 92. The disinfectant is not added until the tank is filled, so that in case of a problem of water assortment, The concentrated disinfectant is not left in the endoscope without water to rinse it. While the disinfectant is added, the pumps of channel 32 are turned off in order to ensure that the disinfectant in the reservoir is found in the concentration in use before undoing through the channels.

Step 26. Disinfect The disinfectant solution in use is actively pumped through the internal channels and on the surface of the endoscope, ideally for a minimum of 5 minutes, by means of the channel pumps and the external circulation pump. The temperature is controlled by in-line heater 80 at approximately 52.5 ° C.

Step 27. Verification of the flow During the disinfection procedure, the flow through each channel of the endoscope is verified by regulating the supply of a measured quantity of solution through the channel. The valve S1 is closed, and the valve S7 is opened, and in turn each channel pump 32 supplies a predetermined volume to its associated channel from the measuring tube 136. This volume and the time it takes to supply provides a flow rate very accurate through the channel. Anomalies in the flow velocity expected for a channel of that diameter and length are weakened by the control system 20 and the procedure is stopped.

Step 28. Continue blogging test Since a disinfectant solution in use is pumped through the channels, the flow rate through the channels is also measured as in step 15.

Step 29. Drain The drain pump 72 is activated to remove the disinfectant solution from the tank and the channels.

Step 30 Blow air During the draining procedure, sterile air is blown through all the channels of the endoscope simultaneously to minimize potential remnants.

Final rinse Step 31. Fill the tank The tank is filled with sterile hot water (45 ° C) that has passed through a 0.2 μ filter.

Step 32. Rinse. The rinse water is circulated within the channels of the endoscope (by means of the pumps of the channel 32) and on the outside of the endoscope (by means of the circulation pump 70 and the spray arm 60) for 1 minute.

Step 33. Continue block test As rinse water is pumped through the channels, the flow rate through the channels is measured as in step 15.

Step 34. Drain The drain pump 72 is activated to remove the rinse water from the tank and the channels.

Step 35. Blow air During the draining procedure, sterile air is blown through all the channels of the endoscope simultaneously to minimize potential remnants.

Step 36. Repeat rinsing Steps 31 to 35 are repeated two more times (a total of 3 post-disinfecting rinses) to ensure maximum reduction of disinfectant residues from endoscope 200 and reprocessor surfaces.

Final spill test Step 37. Pressurize endoscope body and measure leak rate Repeat step 6.

Step 38. Indicate the completion of the program. The successful completion of the program is indicated on the touch screen.

Step 39. De-pressurize the endoscope From the time the program is completed until the time when the lid opens, the pressure inside the endoscope body is normalized to atmospheric pressure when the S5 ventilation valve is opened for 10 seconds each minute.

Step 40 Identify the user Depending on the user's selected configuration, the system will prevent the cover from opening until a valid user identification code is entered.

Step 41. Store program information Information about the completed program, including user ID, endoscope ID, specialist ID and patient ID are stored with the sensor data obtained through the program.

Step 42. Print program record If a printer is connected to the system, and if requested by the user, a record of the disinfection program will be printed.

Step 43. Remove the endoscope. Once the user's valid identification code has been entered, the lid can be opened (using the pedal as in step 1 above). The endoscope is then disconnected from the discharge lines 30 and removed from the reservoir 14a. The lid can then be closed using both hardware and software buttons as described in step 4 above. The invention has been described with reference to preferred embodiments. Obviously, modifications and alterations will occur to others after reading and understanding the above detailed description. It is intended that the invention be constructed as including all such modifications and alterations as long as they are within the scope of the appended claims or their equivalents.

Claims (18)

NOVELTY OF THE INVENTION CLAIMS

1. - A connector for connecting a lumen in a lumen device to a fluid source in an endoscope reprocessor, the connector comprising: a coupling configured to couple with a port connected to the lumen in the lumen device where the port includes a first sealing surface; a flow passage; a sealing portion which is movably connected to the flow passage and which comprises a second sealing surface formed to couple the first sealing surface; the sealing portion formed of an elastic material; and the sealing portion adapted to mate with the first sealing surface under a condition of a first flow in the connector and further adapted to uncouple from the first sealing surface under a condition of a second flow, different from the first flow, in the connector.

2. The connector according to claim 1, further characterized in that the elastic material of the sealing portion deflects the second sealing surface in contact with the first sealing surface when coupled with it, the deviation being such that the second sealing surface is sealed against the first sealing surface when the pressure within the flow passage related to the first flow is below a predetermined level preventing leakage of the flow and because the second surface is not sealed against the first surface when the pressure within the flow passage related to the second flow is above the predetermined level thus allowing flow over the first sealing surface.

3. The connector according to claim 1, further characterized in that the elastic material of the sealing portion deflects the second sealing surface away from contact with the first sealing surface when coupled with it, the deviation being such that the second sealing surface is not sealed against the first sealing surface when the pressure within the flow passage related to the first flow is below a predetermined level allowing leakage of the flow and wherein the sealing portion is oriented from so that when a pressure within the flow passage related to the second flow is above the predetermined level said pressure pushes the second sealing surface in contact with the first sealing surface thereby preventing leakage of the flow.

4. The connector according to claim 1, further characterized in that the sealing portion is formed integral with the connector.

5. The connector according to claim 1, further characterized in that the first sealing surface is cylindrical and wherein the sealing portion comprises an annular flange measured to be placed against the first sealing surface.

6. - The connector according to claim 1, further characterized in that the sealing portion comprises a free distal edge.

7. The connector according to claim 1, further characterized in that the sealing portion is formed of silicone.

8. The connector according to claim 1, further characterized in that the first flow is related to a pressure in the sealing portion less than 0.84 kg / cm2 gauge and the second flow is related to a pressure in the largest sealing portion at 0.84 kg / cm2 gauge.

9. The connector according to claim 1, further characterized in that the first flow is related to a pressure in the sealing portion less than 0.35 kg / cm2 gauge and the second flow is related to a pressure in the larger sealing portion at 0.35 kg / cm2 gauge.

10. A method for connecting a port in a lumen device to an endoscope reprocessor and flowing fluid through the port; the method comprises the steps of: attaching a coupling in the endoscope reprocessor to the port, the coupling having a flow passage therethrough, and a sealing portion that is movably fixed to the flow passage, the movable seal portion from a first position to a second position, and the sealing portion formed of an elastic material that deviates in one of the first or second position; flowing a first flow through the passage of the flow and into the port causing the sealing portion to move in the first position; flowing a second different flow through the flow passage which causes the sealing portion to move in the second position; and wherein one of the first position and the second position comprises a sealing position wherein the sealing portion is sealed against a first sealing surface in the port to prevent the flow from passing, and wherein the other first position and the second position comprises a non-sealed position wherein the sealing portion is away from the first sealing surface to allow flow over the first sealing surface.

11. The method according to claim 10, further characterized in that the first position is the sealing position.

12. The method according to claim 11, further characterized in that the sealing portion is biased toward the first position.

13. The method according to claim 10, further characterized in that the sealing portion is biased towards the first position.

14. The method according to claim 10, further characterized in that the second flow has a pressure greater than the first flow.

15. - The method according to claim 14, further characterized in that the upper pressure is created by increasing the volume of the second flow.

16. The method according to claim 14, further characterized in that the second flow has a pressure above 0.84 kg / cm2 gauge.

17. The method according to claim 10, further characterized in that the second flow is in a different direction to the first flow.

18. The method according to claim 10, further characterized in that the first flow comprises a fluid selected from a list consisting of: wash fluid, an antimicrobioan agent and combinations thereof.