Adapter device and method for connecting two surgical instruments with a leak detection device and reprocessing device

Abstract

The invention relates to an adapter device 20 and a method for connecting two surgical instruments 11, 12 to a leak detection device 7. The invention further relates to the reprocessing device 1 comprising the leak detection device 7 and the adapter device 20. The adapter device 20 has a Y-shaped section 20a with three legs 21, 22, 23. The three legs 21, 22, 23 comprise a first leg 21, which is designed to be connected to the leak detection device 7, a second leg 22, which is designed to be connected to a first surgical instrument 11, and a third leg 23, which is designed to be connected to a second surgical instrument 12.The adapter device 20 is designed to create an airtight connection between the leak detection device 7 and the surgical instruments 11, 12, enabling the leak detection device 7 to simultaneously pressurize the first surgical instrument 11 and the second surgical instrument 12 with pressurized gas. The third leg 23 has a flow control element 24 designed to change the flow resistance of the third leg 23 depending on the flow direction.

Description

[0001] The invention relates to an adapter device for connecting two surgical instruments to a leak detection device of a reprocessing unit. The invention further relates to a reprocessing unit and a method for connecting two surgical instruments to a leak detection device.

[0002] Surgical instruments, such as endoscopes, require reprocessing after each use to prevent contamination of other patients. Reprocessing involves cleaning and disinfecting the surgical instruments and is often performed by automated reprocessing units. These units typically have one or more baskets in which the surgical instruments are placed. To clean not only the exterior but also the internal channels of the surgical instruments, the internal channels are usually connected to tubes that apply a cleaning solution and compressed air to clean, disinfect, and dry the channels.

[0003] This requires that certain critical parts of the endoscope, such as the camera or fibers, be detached from the channels and outer casing to protect them from water. This detached section of the endoscope is connected to a leak detector to ensure it remains sealed and pressurized during reprocessing. A preliminary leak test must always be performed before cleaning begins. During this process, the leak detector first identifies the presence of an endoscope by accessing the connected volume, which then needs to be filled. The leak detector then pressurizes the protected portion of the endoscope to the required test pressure and assesses whether the pressure is maintained over time.

[0004] When reprocessing small surgical instruments, such as bronchoscopes, it is possible to arrange two such instruments in a single basket to speed up the reprocessing of multiple instruments. These small surgical instruments are then connected to the leak detection device via a Y-shaped adapter to pressurize both instruments simultaneously.

[0005] However, when using such an adapter, the reprocessing device cannot detect whether one or two endoscopes are connected to the leak detection device. Furthermore, the detection of a leak in one of the surgical instruments is reduced because the pressure loss due to the leak is halved by splitting the compressed air flow into two streams. This means that the pressure drop from one endoscope is partially absorbed by the second connected endoscope.

[0006] JP H08-243 080 A shows a device for cleaning and disinfecting endoscopes. An air supply hose is connected to the device via a connector. The air supply hose splits into two hoses to supply air to different inlets of the endoscope.

[0007] EP 3 449 804 A1 discloses a method and a device for simultaneously testing adapter connections and checking the patency of endoscope channels. The device is connected via an adapter to two inlets of the endoscope channels simultaneously using two hoses.

[0008] The object of the present invention is to improve the detection and testing of a leak between two surgical instruments connected by a single leak detection device.

[0009] This problem is solved by an adapter device for connecting two surgical instruments to a leak detection device of a reprocessing device, wherein the adapter device has a Y-shaped section with three legs, the three legs comprising a first leg designed to be connected to the leak detection device, a second leg designed to be connected to a first surgical instrument, and a third leg designed to be connected to a second surgical instrument, wherein the adapter device is designed to create an airtight connection between the leak detection device and the surgical instruments in order to enable the leak detection device to simultaneously pressurize the first surgical instrument and the second surgical instrument with pressurized gas, wherein the third leg comprises a flow control element.wherein the flow control element is designed to change the flow resistance of the third leg depending on the flow direction.

[0010] By using a Y-shaped adapter device, which is equipped with a flow control element in one of its arms, the flow resistance of the pressurized gas changes depending on the flow direction. Compared to connecting only a single surgical instrument to the leak detection device, the time required to pressurize and the time required to depressurize are different.

[0011] Flow resistance is the resistance of the pressurized gas, e.g., air, as it flows through the third limb. Increasing the flow resistance in the third limb makes it take longer to pressurize or release the pressure in the second surgical instrument.

[0012] The flow control element is located in the third leg. The second leg, in particular, does not have a flow control element. This makes it possible to distinguish whether only one surgical instrument, two surgical instruments, or no surgical instrument at all is connected to the leak detection device.

[0013] The adapter device may have additional parts besides the Y-shaped section. For example, the adapter device may have tubular extensions of the first leg, the second leg, and / or the third leg.

[0014] Preferably, the flow control element is designed to increase the flow resistance in a first direction, while the flow control element is designed not to change or decrease the flow resistance in a second direction opposite to the first. By increasing the flow resistance in the first direction and decreasing, or at least not increasing, the flow resistance in the opposite second direction, the reprocessing device is able to detect the use of the adapter device. By measuring the time required to pressurize and release the pressure within the surgical instruments, and comparing these times with the case where only a single surgical instrument is connected, the reprocessing device can differentiate between these two cases.

[0015] Preferably, the first direction is towards the leak detection device, and the second direction is away from the leak detection device. Thus, the flow resistance for the gas increases when the gas flows from the second surgical instrument towards the leak detection device. When the gas flows from the leak detection device towards this second surgical instrument, the flow resistance remains unchanged or even decreases. This allows differentiation between the various connection scenarios without hindering the leak test. It should be noted that a pressure drop over time due to a leak is at least one order of magnitude smaller than a pressure drop due to air release.

[0016] According to one embodiment, the flow control element comprises a diaphragm, the diaphragm being designed to increase the flow resistance in the first direction and not to change or decrease the flow resistance in the second direction. The diaphragm slows the flow in the first direction but does not impede the flow in the second direction.

[0017] According to one embodiment, the flow control element includes a throttle valve. The throttle valve has two parallel channels, one of which is a one-way valve and the other has a reduced diameter. This increases the flow resistance in the first direction but does not restrict the flow in the second direction.

[0018] For example, if the throttle valve reduces the flow by 50%, filling is twice as fast as emptying if only one endoscope is connected. The same applies if only one endoscope is connected. However, if both endoscopes are connected simultaneously, filling is 1.5 times faster than emptying.

[0019] According to another embodiment, the third leg has two parallel channels, the flow control element comprising a one-way valve, the one-way valve being located in one of the two channels. In other words, the third leg is divided into the two channels, at least in part along its length. One of the two channels has the one-way valve. In particular, the other channel does not have a one-way valve or a similar flow control element. The one-way valve provides a different flow resistance depending on the flow direction. When the one-way valve is open, the flow resistance of the third leg is unimpeded. In the opposite direction, however, the gas can only flow through the other channel when the one-way valve is closed, thereby reducing the flow resistance of the third leg.In particular, the beginnings of the two channels are connected and the ends of the two channels are connected.

[0020] Preferably, the combined flow resistance of the two channels of the third leg is equal to the flow resistance of the second leg when the one-way valve is open, wherein the combined flow resistance of the two channels of the third leg is greater than the flow resistance of the second leg when the one-way valve is closed. By designing the flow resistance of the two channels in this way, the gas flow is only restricted in one direction, while the gas can flow freely in the other direction.

[0021] The problem is further solved by a reprocessing device comprising a leak detection device and an adapter device according to one of the preceding embodiments, wherein the leak detection device has a connection part designed to be connected to the first leg of the adapter device.

[0022] The reprocessing device embodies the same advantages and features as the adapter device described above.

[0023] In particular, the leak detection device is integrated into the reprocessing unit. The reprocessing unit may have an interior with one or more baskets. The baskets are designed to hold the surgical instruments while they are being reprocessed. Two small surgical instruments, such as bronchoscopes, can be placed on a single level of the reprocessing unit. In other words, the surgical instruments are placed in the same basket. The adapter device is used to connect both to the leak detection device.

[0024] Preferably, the reprocessing device comprises a control unit, wherein the control unit is configured to measure a pressurization time and a pressure release time, the pressurization time being the time required to pressurize all surgical instruments connected to the leak detection device, and the pressure release time being the time required to release the pressure from all surgical instruments connected to the leak detection device. The control unit is further configured to determine, by comparing the pressurization time and the pressure release time, whether one or two surgical instruments are connected to the leak detection device. The control unit can be called a controller and can be a computer or similar device.

[0025] If only a single surgical instrument is connected to the leak detection device, the adapter is not used. Instead, the surgical instrument is connected to the leak detection device via a simple tube or similar connector. In this case, the pressurization time and the depressurization time are usually the same.

[0026] If two surgical instruments are connected to the leak detection device, the adapter is used to connect them. Since the third arm of the adapter exhibits flow resistance depending on the flow direction, the pressurization and depressurization times of the second surgical instrument connected to the third arm differ. Consequently, the pressurization and depressurization times measured by the leak detection device also differ. Thus, by comparing the pressurization and depressurization times, the control unit can determine whether zero, one, or two surgical instruments are connected to the leak detection device. This can be achieved with a simple software routine. Apart from the adapter, no hardware modifications to the reprocessing device are required.Older reprocessing devices can be brought up to date by replacing the adapter device and installing a simple software update.

[0027] The problem is further solved by a method for connecting two surgical instruments to a leak detection device of a reprocessing device, wherein an adapter device is connected to the leak detection device, a first surgical instrument and a second surgical instrument, wherein the adapter device has a Y-shaped section with three legs, the three legs comprising a first leg connected to the leak detection device, a second leg connected to the first surgical instrument and a third leg connected to the second surgical instrument, wherein the adapter device establishes an airtight connection between the leak detection device and the surgical instruments, wherein the leak detection device simultaneously pressurizes the first surgical instrument and the second surgical instrument with pressurized gas, and wherein the third leg comprises a flow control element.wherein the flow control element changes the flow resistance of the third leg depending on the flow direction.

[0028] The method embodies the same features and advantages as the adapter device and the reprocessing device discussed above.

[0029] Preferably, the flow control element increases the flow resistance in a first direction, wherein the flow control element does not change or decrease the flow resistance in a second direction opposite to the first direction.

[0030] Preferably, the first direction is a direction towards the leak detection device, wherein the second direction is a direction away from the leak detection device.

[0031] According to one embodiment, the flow control element has a diaphragm, wherein the diaphragm increases the flow resistance in the first direction and does not change or decrease the flow resistance in the second direction.

[0032] According to another embodiment, the third leg has two parallel channels, wherein the flow control element has a one-way valve, the one-way valve being arranged in one of the two channels.

[0033] Preferably, the combined flow resistance of the two channels of the third leg is equal to the flow resistance of the second leg when the one-way valve is open, wherein the combined flow resistance of the two channels of the third leg is greater than the flow resistance of the second leg when the one-way valve is closed.

[0034] Preferably, the reprocessing device comprises a control device, wherein the control device is designed to measure a pressurization time and a pressure release time, wherein the pressurization time is the time required to pressurize all surgical instruments connected to the leak detection device, wherein the pressure release time is the time required to release the pressure from all surgical instruments connected to the leak detection device, wherein the control device further determines, by comparing the pressurization time and the pressure release time, whether one or two surgical instruments are connected to the leak detection device.

[0035] Further embodiments of the invention will become apparent from the description of the embodiments according to the invention together with the claims and the accompanying drawings. Embodiments according to the invention can fulfill individual features or a combination of several features.

[0036] The invention is described below with reference to exemplary embodiments without limiting the general inventive concept, with regard to the disclosure of all aspects not explained in detail in the text.

[0037] For details according to the invention, explicit reference is made to the drawings. The drawings show: Fig. 1. A schematic, simplified perspective drawing of a reprocessing device for reprocessing surgical instruments, Fig. 2 a schematic, simplified drawing of a first embodiment of an adapter device and Fig. 3 a second embodiment of an adapter device.

[0038] In the drawings, identical or similar elements or corresponding parts are provided with the same reference numerals, so that a corresponding re-presentation is omitted.

[0039] Fig. Figure 1 shows a schematic, simplified representation of a reprocessing device 1 designed to reprocess surgical instruments 11, for example, endoscopes. The reprocessing device 1 has a housing 2 with an opening and a door 8. One or more baskets 3 are arranged inside the opening and can be pulled out of the reprocessing device 1 along rails 4. To control the reprocessing device 1, it includes a user interface 5 and a control unit 6, for example, a computer.

[0040] During the reprocessing of the surgical instruments 11, the instruments are cleaned and disinfected externally. In addition, the internal channels of the surgical instruments 11 are cleaned and disinfected. For this purpose, the surgical instruments 11 are rinsed with a cleaning fluid and then dried with pressurized gas. Before this can be done, the connection to the surgical instruments 11 is checked by a leak detection device 7, which, for example, blows compressed air into the internal channels to check whether the connection is correct. To check for leaks, the leak detection device 7 typically pressurizes the internal channels of the surgical instruments 11 before depressurizing them again. If there is an anomaly in the resulting pressure, such as a pressure drop, this indicates a leak or a faulty connection.

[0041] Fig. Figure 2 shows a simplified, schematic drawing of an adapter device 20 for simultaneously connecting the leak detection device 7 to two surgical instruments 11, 12. The adapter device 20 has a Y-shaped section 20a with a first leg 21, a second leg 22, and a third leg 23. The first leg 21 is designed to be connected to a connecting part 21a of the leak detection device 7, the second leg 22 is designed to be connected to the first surgical instrument 11, and the third leg 23 is designed to be connected to a second surgical instrument 12.

[0042] The use of such a Y-shaped adapter device 20 allows two surgical instruments 11, 12 to be connected to a single leak detection device 7. Normally, however, the reprocessing device 1 could not identify how many surgical instruments 11, 12 are connected to the leak detection device 7. For this reason, the third leg 23 has a flow control element 24, in this case a diaphragm. This flow control element 24 is designed to change the flow resistance in one direction, but not in the opposite direction. For example, during the pressure release step, when the gas flows in a first direction 31 from the surgical instruments 11, 12 toward the leak detection device 7, the flow control element 24 increases the flow resistance and thus the time required to release the pressure.However, during the pressurization step, when the gas flows in the opposite, second direction 32 from the leak detection device 7 towards the surgical instruments 11, 12, the flow control element 24 does not impede the gas flow and does not change either the flow resistance or the time required for pressurization. This allows the control unit 6 to detect the number of surgical instruments 11, 12 connected to the leak detection device 7 by measuring the pressurization time and the pressure release time. For example, if only the first surgical instrument 11 is connected, the pressurization time is approximately equal to the pressure release time. If only the second surgical instrument 12 is connected to the adapter device 20, the pressurization time may be half as long as the pressure release time.If both surgical instruments 11, 12 are connected, the pressure application time is shorter, but not quite half as short as the pressure release time.

[0043] Fig. Figure 3 shows another simplified, schematic representation of a different embodiment of the adapter device 20. Fig.Section 3 of the Y-shaped section 20a has a third leg 23 with two channels 23a and 23b. These channels run parallel for at least part of the length of the third leg 23. Only one of the two channels 23a and 23b has the flow control element 24, which is a one-way valve. The one-way valve completely blocks the gas flow in the first direction 31, while it does not impede the gas flow in the second direction 32. However, due to the other channel 23b, gas will still flow even when the one-way valve is closed. Thus, the one-way valve increases the flow resistance in the first direction 31 without changing the flow resistance in the second direction 32.

[0044] All mentioned embodiments, including those discernible from the drawings alone, as well as individual embodiments disclosed in combination with other embodiments, are considered essential to the invention, both individually and in combination. Embodiments of the invention can be fulfilled by individual embodiments or by a combination of several embodiments. Features combined with the words "in particular" or "especially" are to be treated as preferred embodiments. Reference symbol list 1 Reprocessing device 2 cases 3 basket 4 rail 5 User Interface 6 Control unit 7 Leakage testing device 8 Door 11, 12 surgical instrument 20 adapter device 20a Y-shaped section 21 first thigh 21a Connection part 22 second thigh 23 third thigh Channels 23a and 23b 24 Flow control element 31 first direction 32 second direction

Claims

Adapter device (20) for connecting two surgical instruments (11, 12) to a leak detection device (7) of a reprocessing device (1), wherein the adapter device (20) has a Y-shaped section (20a) with three legs (21, 22, 23), the three legs (21, 22, 23) comprising a first leg (21) designed to be connected to the leak detection device (7), a second leg (22) designed to be connected to a first surgical instrument (11), and a third leg (23) designed to be connected to a second surgical instrument (12), wherein the adapter device (20) is designed to create an airtight connection between the leak detection device (7) and the surgical instruments (11, 12) to enable the leak detection device (7) to simultaneously test the first surgical instrument (11) and the second surgical instrument (12) with to apply compressed gaswherein the third leg (23) has a flow control element (24), wherein the flow control element (24) is designed to change a flow resistance of the third leg (23) depending on the flow direction. Adapter device (20) according to claim 1, wherein the flow control element (24) is designed to increase the flow resistance in a first direction (31), wherein the flow control element (24) is designed not to change or decrease the flow resistance in a second direction (32) opposite to the first direction. Adapter device (20) according to claim 2, wherein the first direction (31) is a direction towards the leak detection device (7), wherein the second direction (32) is a direction away from the leak detection device (7). Adapter device (20) according to claim 2 or 3, wherein the flow control element (24) has a diaphragm, wherein the diaphragm is designed to increase the flow resistance in the first direction (31) and not to change or decrease the flow resistance in the second direction (32). Adapter device (20) according to one of claims 1 to 4, wherein the third leg (23) has two parallel channels (23a, 23b), wherein the flow control element (24) has a one-way valve, wherein the one-way valve is arranged in one of the two channels. Adapter device (20) according to claim 5, wherein the combined flow resistance of the two channels (23a, 23b) of the third leg (23) is equal to the flow resistance of the second leg (22) when the one-way valve is open, wherein the combined flow resistance of the two channels (23a, 23b) of the third leg (23) is greater than the flow resistance of the second leg (22) when the one-way valve is closed. Reprocessing device (1) comprising a leak detection device (7) and an adapter device (20) according to any one of claims 1 to 6, wherein the leak detection device (7) has a connecting part (21a) designed to be connected to the first leg (21) of the adapter device. Reprocessing device (1) according to claim 7, comprising a control device (6), wherein the control device (6) is configured to measure a pressurization time and a pressure release time, wherein the pressurization time is the time required to pressurize all surgical instruments (11, 12) connected to the leak detection device (7), wherein the pressure release time is the time required to release the pressure from all surgical instruments (11, 12) connected to the leak detection device (7), wherein the control device (6) is further configured to detect, by comparing the pressurization time and the pressure release time, whether one or two surgical instruments (11, 12) are connected to the leak detection device (7). Method for connecting two surgical instruments (11, 12) to a leak detection device (7) of a reprocessing device (1), wherein an adapter device (20) is connected to the leak detection device (7), a first surgical instrument (11) and a second surgical instrument (12), wherein the adapter device (20) has a Y-shaped section (20a) with three legs (21, 22, 23), wherein the three legs (21, 22, 23) comprise a first leg (21) connected to the leak detection device (7), a second leg (22) connected to the first surgical instrument (11) and a third leg (23) connected to the second surgical instrument (12), wherein the adapter device (20) establishes an airtight connection between the leak detection device (7) and the surgical instruments (11, 12).wherein the leak detection device (7) simultaneously pressurizes the first surgical instrument (11) and the second surgical instrument (12) with pressurized gas, wherein the third leg (23) has a flow control element (24), wherein the flow control element (24) changes a flow resistance of the third leg (23) depending on the flow direction. Method according to claim 9, wherein the flow control element (24) increases the flow resistance in a first direction (31), wherein the flow control element (24) does not change or decrease the flow resistance in a second direction (32) opposite to the first direction. Method according to claim 10, wherein the first direction (31) is a direction towards the leak detection device (7), wherein the second direction (32) is a direction away from the leak detection device (7). Method according to claim 10 or 11, wherein the flow control element (24) has a membrane, wherein the membrane increases the flow resistance in the first direction (31) and does not change or decrease the flow resistance in the second direction (32). Method according to one of claims 9 to 12, wherein the third leg (23) has two parallel channels (23a, 23b), wherein the flow control element (24) has a one-way valve, wherein the one-way valve is arranged in one of the two channels (23a, 23b). Method according to claim 13, wherein the combined flow resistance of the two channels (23a, 23b) of the third leg (23) is equal to the flow resistance of the second leg (22) when the one-way valve is open, wherein the combined flow resistance of the two channels (23a, 23b) of the third leg (23) is greater than the flow resistance of the second leg (22) when the one-way valve is closed. A method according to any one of claims 9 to 14, wherein the reprocessing device (1) comprises a control device (6), wherein the control device (6) measures a pressurization time and a pressure release time, wherein the pressurization time is the time required to pressurize all surgical instruments (11, 12) connected to the leak detection device (7), wherein the pressure release time is the time required to release the pressure from all surgical instruments (11, 12) connected to the leak detection device (7), wherein the control device (7) further determines, by comparing the pressurization time and the pressure release time, whether one or two surgical instruments (11, 12) are connected to the leak detection device (7).

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