reprocessing tank

Abstract

A reprocessing tank can be used to help reprocess instruments, such as endoscopes, in an automated reprocessor. The reprocessing tank can include various features such that the tank can include and transition between a closed configuration, an open configuration, and a sterilization configuration. In particular, during a reprocessing procedure, the reprocessor can transition the tank to the sterilization configuration.

Description

Technical Field

[0001] This application is a divisional application of Chinese application number 201980084699.5. The subject matter disclosed herein relates to systems for the reprocessing of medical devices, particularly the automated reprocessing of endoscopes. Background Technology

[0002] Endoscopes are reusable medical devices. Between medical procedures, endoscopes should be reprocessed, i.e., cleaned, where this is done to avoid causing infection or disease in the subject. As documented in various news reports, endoscopes are difficult to clean. See, for example, Chad Terhune, “Superbug outbreak: UCLA will test new scope cleaning machine,” LA Times, July 22, 2015, http: / / www.latimes.com / business / la-fi-ucla-superbug-scope-testing-20150722-story.html (last accessed October 30, 2017). Typically, endoscope reprocessing is performed through a sterilization procedure that includes at least the following steps: removing foreign objects from the endoscope, cleaning the endoscope, and sterilizing the endoscope by immersing it in a disinfectant capable of substantially killing microorganisms on it, such as bacteria that cause infection. An exemplary disinfectant is manufactured and distributed by the applicant. OPA solution, an advanced sterilization product, is a division of Johnson & Johnson Company (“ASP”), Ethicon US, LLC.

[0003] Endoscopic reprocessing can be performed by healthcare professionals or by machines such as automated endoscope reprocessors (“AERs”), like ASPs. This is performed with the aid of an endoscope cleaner and reprocessor. At the point of care, the initial reprocessing step should be performed immediately after or shortly after the endoscope's use in a procedure to remove the bioburden from the endoscope before it dries out. The initial steps are typically performed by a nurse and include wiping the endoscope, immersing it in a detergent solution, aspirating the detergent through the endoscope, aspirating air through the endoscope, and rinsing the passageway. After performing the initial steps, the endoscope can be transported to a reprocessing area for further reprocessing, such as sterilization in an AER. After sterilization, the endoscope can be stored for its next use. Summary of the Invention

[0004] This document discloses a reprocessing box for instruments, such as medical devices, particularly endoscopes, which can be used to assist in the reprocessing of instruments in automated reprocessors, such as automated endoscope reprocessors. The reprocessing box may include a first section having a first housing and a first panel. The first housing has a first cylinder, and the first panel is connected to a first piston at least partially disposed within the first cylinder. The first panel may include a first port disposed through the first panel and a first valve disposed in the first port. A first tube may be connected to the first valve.

[0005] The reprocessing chamber may further include a second section having a second housing and a second panel. A hinge may connect the first housing to the second housing. The second housing may further include a second cylinder. Therefore, the second panel may include a connection to a second piston at least partially disposed within the second cylinder. The second panel may further include a second port disposed through the second panel and a second valve disposed in the second port. A second tube may be connected to the second valve.

[0006] In a closed configuration, the first panel can contact the first housing, and the first housing can contact the second housing. In a further closed configuration, the second panel can contact the second housing. In a disinfection configuration, the first panel can be displaced from the first housing such that the first panel does not contact the first housing. In a further disinfection configuration, the second panel can be displaced from the second housing such that the second panel does not contact the second housing. In at least one disinfection configuration, the first panel can be angled outward from the first housing. In a further or alternative disinfection configuration, the second panel can be angled outward from the second housing.

[0007] In addition, the reprocessing box may include a manifold. The manifold may be at least partially located on the first panel. Alternatively or additionally, the manifold may be integrated into a first or second section of the box. The manifold may include at least one inlet port and at least four outlet ports, such as eight outlet ports.

[0008] The container may also include a discharge port. It may also include a nozzle attached to at least one of the output ports. The nozzle may include a rotary nozzle.

[0009] According to the following methods and variations, the reprocessing box can be used to assist in the reprocessing of medical devices. First, the reprocessing box can be opened to an open configuration. Second, a medical device, such as an endoscope, can be placed in the reprocessing box. Third, the reprocessing box can be closed to a closed configuration. Fourth, the reprocessing box can be placed in a reprocessor. Fifth, the reprocessing box can be configured for sterilization. Sixth, the medical device can be sterilized, for example, by spraying the endoscope with a disinfectant. Additionally, before spraying the endoscope with disinfectant, a cleaning agent can be sprayed on the endoscope. Seventh, the reprocessing box can be returned to a closed configuration.

[0010] In some variations of this method, the fluid delivery component may be fitted to a port of the reprocessing chamber. This port may include the inlet port of a manifold. The port may be additionally or alternatively disposed through one side of the reprocessing chamber. The lumen of the medical device may also be connected to the port. Therefore, the sterilization step may include sterilizing the lumen of the medical device. Attached Figure Description

[0011] Although this specification concludes with claims, which specifically point out and clearly claim protection for the subject matter described herein, it is believed that the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements, and wherein:

[0012] Figure 1 The reprocessing bin in a closed configuration is depicted;

[0013] Figure 2 Depicting the first disinfection configuration Figure 1 Reprocessing box;

[0014] Figure 3 Describes the configuration in the open state. Figure 1 Reprocessing box;

[0015] Figure 4 Describing the configuration as with Figure 1 The first fluid delivery assembly is coupled with the reprocessing tank;

[0016] Figure 5 Depicting the second disinfection configuration Figure 1 Reprocessing box;

[0017] Figure 6 Depicting what can be combined with Figure 1 The second fluid delivery component used in conjunction with the reprocessing tank;

[0018] Figure 7 A reprocessing box in a closed configuration is described; the reprocessing box includes a manifold.

[0019] Figure 8 Depicting the open configuration Figure 7 The reprocessing box; and

[0020] Figure 9 A cross-sectional view of the reprocessing box, including the integrated manifold, is depicted. Detailed Implementation

[0021] The following detailed description should be read with reference to the accompanying drawings, in which the same elements in the various drawings are indicated by the same numerals. The drawings, not necessarily drawn to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example rather than limitation. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, substitutions, and uses of the invention, including what is currently considered the best mode for carrying out the invention.

[0022] As used herein, the terms “about” or “approximately” for any numerical value or range indicate a suitable dimensional tolerance that allows a collection of parts or components to be used for its intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of ±10% of the stated value; for example, “about 90%” can refer to a numerical range from 81% to 99%. Furthermore, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the system or method to human use, although use of the invention in human patients represents a preferred embodiment.

[0023] This article describes a reprocessing box that can be used for the sterilization and subsequent storage of medical devices via AER (Automatic Erector Discharge). The reprocessing box 100... Figure 1 The configuration is shown as off in [the image / image]. Figure 2 The image shows the disinfection configuration, and in Figure 3 The box is shown in the open configuration. Box 100 includes a first section 102 and a second section 104. The first section 102 includes a first housing 106 having a first panel 108. The second section 104 includes a second housing 110 having a second panel 112. The first housing 106 and the second housing 110 are hinged together, allowing the first section 102 and the second section 104 to rotate relative to each other to open the box configuration. Figure 1 The configuration to be turned off has been changed to Figure 3 The open configuration. Sections 102 and 104 can be made of any robust material, including metals and plastics, or combinations thereof. For example, the entire box 100 can be made of one or more materials or combinations thereof. Stainless steel is an exemplary metal, and polycarbonate is an exemplary plastic. Thus, at least a portion of the box can be transparent, translucent, or opaque.

[0024] At least one hook, such as two hooks 114, can be attached to housing 106 or housing 110 and can be secured to another housing, such that the two housings can be secured to each other, similar to a briefcase. A handle may be additionally provided near the hooks on one of the two housing components. Thus, certain features of the case 100 can be described as resembling a conventional briefcase.

[0025] The housing 100 may additionally include various ports disposed through housings 106 and 110. For example, as shown, ports 116, 118, 120, and 122 are disposed through panel 108. These ports may respectively contain valves 124, 126, 128, and 130, which may be check valves, duckbill valves, umbrella valves, or X-fragm valves, such as those manufactured by Minivalve, Inc., Cleveland, Ohio. Although four ports and valves are shown, any number of valves and ports may be suitably present, such as between one port and ten ports, and between one valve and ten valves. These ports and valves may provide fluid delivery to the AER access fluid delivery assembly 132 inside the housing 100 during the sterilization process. Figure 4 ), and contaminants are restricted from entering the container during storage after the procedure.

[0026] Fluid delivery assembly 132 may be included as a sub-assembly of the AER and disposed within the reprocessing chamber. In addition to delivering liquid into tank 100, assembly 132 may also be used to configure the tank from... Figure 1 The closing position has been changed to Figure 2 The disinfection configuration. For example, component 132 can be connected to the wall of the reprocessing chamber via a linear actuator, such that the linear actuation of component 132 moves component 132 away from the wall, toward the chamber 100, and eventually into contact with the chamber 100.

[0027] Once component 132 extends from its original position and onto the housing, it engages with a capture feature of the housing 100's connection feature for mechanical manipulation purposes, such as movement of panel 108 away from housing 106. The capture feature may be a spring-loaded cam or mechanical fingers that engage with the connection feature by press-fit, friction fit, or snap-fit. The connection feature may include slots 134 and 136. A cover 140, such as a flexible sheet of silicone, may be attached to the inner surface of panel 108 above slots 134 and 136 to allow engagement of component 132 while providing a barrier to the exterior of panel 108 to limit contaminants from entering the housing through slots 134 and 136 during post-process storage. Alternatively, a second cover 142 may be included, such that cover 140 covers slot 134 while cover 142 covers slot 136.

[0028] Once the capture feature of component 132 engages with the connection feature of housing 100, component 132 translates back toward the wall, i.e., its original position, pulling surface 108 away from housing 106 to transition housing 100 from a closed configuration to a sterilized configuration. After the cycle is complete, the housing wall returns to the closed configuration, and the capture feature is released to detach component 132 from the connection feature of housing 100. Releasing the capture feature can be associated with an individual movement of component 132, such as negative travel from its original position.

[0029] Figure 2 The image reflects a case 100 in a sterilization configuration, in which panel 108 is displaced from housing 106, while panel 112 is displaced from housing 110. As mentioned above, slots 134 and 136 may engage with features on assembly 132 such that assembly 132 may pull panel 108 away from housing 106 or push panel 108 back into contact with housing 106. Cylinders or pistons (e.g., 170, 174, 178) may be disposed within cylinders (e.g., 172, 176, 180 (concealed)) of housing 106 and may assist in guiding panel 108 between the two positions corresponding to the closed and sterilization configurations. Alternatively or additionally, panel 106 may move between its two positions without the assistance of assembly 132. For example, a motor, such as a stepper motor, may be included within at least one cylinder in the cylinder to move its corresponding piston into and out of the cylinder. The motor may be battery powered. Alternatively or additionally, a spring (e.g., spring 144) may be included within either of the cylinders or around either of the pistons to help return the housing 100 to its closed configuration. A gasket or gasket material may be adhered around the periphery of the housing 106, panel 108, or both, such that the housing 106 and panel 108 form a seal when the housing 100 is in the closed configuration. Similarly, a gasket or gasket material may be adhered around the housing 110, panel 112, or both, such that the housing 110 and panel 112 form a seal when the housing 100 is in the closed configuration.

[0030] Alternative disinfection configurations Figure 5 This is reflected in the configuration. In this sterilization setup, panels 108 and 112 are angled outwards from their corresponding housings 106 and 110. This can be achieved by giving some pistons a longer stroke than others. For example, in Figure 5 In this case, piston 170 extends further outside cylinder 172 than piston 174 extends further outside cylinder 176.

[0031] Figure 3The image reflects a case 100 in an open configuration, where sections 102 and 104 are positioned at 90 degrees or approximately 90 degrees relative to each other, in a configuration similar to the open configuration of a conventional briefcase. In this open configuration, a medical device, such as an endoscope 10, can be placed in the case before a sterilization procedure or removed from the case after a sterilization procedure. Additionally or alternatively, case 100 may include one or more tubes, such as... Figure 3 As shown, there are four tubes 151, 153, 155, and 157. One end of each tube can be connected to valves 124, 126, 128, or 130, for example, valve 128. The other ends of these tubes can be connected to the lumen of the endoscope, for example, via a port on control body 12, a port on optical connector 13, or via the distal end of insertion tube 16. This connection facilitates the delivery of disinfectant, cleaning agent, water, or air through the lumen of the endoscope.

[0032] The container 100 may additionally include a discharge slot 149, which may be covered by a door or cover 147 hinged around at least one hinge 161. Thus, the discharge slot can be opened during the disinfection process to allow liquids (e.g., disinfectants, cleaning agents, water) to drain from the container 100, but should be closed after the process during storage to avoid contamination.

[0033] AER's fluid delivery component 132 in Figure 4 As shown in the diagram. Component 132 can be considered a manifold and includes at least one pipe or water pipe for guiding fluid (e.g., disinfectant, cleaning agent) from a corresponding supply source to tank 100. For example, as Figure 4 As can be seen, component 132 includes tubes 152, 154, 156, and 158. The proximal portion of each of these tubes can be connected via a larger tube 160 to a fluid supply source within the AER, which maintains each of the tubes 152, 154, 156, and 158 for tissue preparation and prevents stress on the tube connections during manipulation of component 132 during sterilization procedures. The distal ends of each tube 152, 154, 156, and 158 can be supported by support clamps and connected to corresponding nozzles 162, 164, 156, and 158. Figure 4 The nozzles are concealed in the middle, and 166 and 168 are fitted together. These nozzles are configured to insert into ports 116, 118, 120 and 122 and open valves 124, 126, 128 and 130. In this way, fluid (e.g. disinfectant, cleaning agent, water or air) can be delivered into the tank 100 via the tubes, nozzles and valves.

[0034] Figure 6A second fluid delivery assembly 146 is shown, which can be used as a supplement to or alternative to assembly 132. Assembly 146 includes a manifold 184 supported by two support rods 148 and 150, and the manifold 184 is connected to a supply line 186, which is connected to a supply source of the AER, such as air, water, disinfectant, or cleaning agent. The manifold 184 also includes nozzles 188, 190, and 192 from which fluid can exit. When the chamber 100 is in the sterilization configuration, the manifold 184 can be inserted into the chamber 100 through the space between panel 108 and housing 106 or the space between panel 112 and housing 110. Thus, in embodiments including assemblies 132 and 146, assembly 132 can be used, or at least primarily used, to allow fluid to flow through the endoscope lumen, while assembly 146 can be used, or at least primarily used, to spray fluid onto the exterior of the endoscope.

[0035] Figure 7 and Figure 8 Alternative embodiments of the reprocessing box 200 in both closed and open configurations are described. Box 200 includes a first section 202 having a first panel 208 and a second section 204 having a second panel 212. A first manifold 260 may be disposed on the section 202 including panel 208. A second manifold 261 may be disposed on the section 204 including panel 212. Manifold 260 may include an inlet port 262, and manifold 261 may include an inlet port 263. Manifolds 260 and 261 may also include various outlet ports. For example, as in... Figure 8 As can be seen, manifold 261 includes eight outlet ports 265. It may also include at least one tube 251 for connecting one of the outlet ports 265 to the lumen of endoscope 10. Thus, fluid (e.g., air, disinfectant, water, or cleaning agent) introduced into one or both of inlets 262 and 263 can be introduced into the housing 200 and the endoscope lumen to disinfect the endoscope. In a further embodiment, one or more of the outlet ports 265 may be equipped with nozzles 266, such as rotary nozzles.

[0036] Additional flow mechanisms can be provided to the reprocessing bins, including bins 100 and 200. One such flow mechanism is an integrated manifold, such as... Figure 9 As shown. Figure 9A section 302 of box 300 is shown, which is similar to section 102 or 104 of box 100, or section 202 or 204 of box 200. A manifold includes a tube 352 in the body of section 302 and wraps around almost the entire contour of the body starting from a first inlet or inlet port 324, such that the section includes the manifold. Additional inlets to tube 352, such as a second inlet 326, may be provided. One or more outlet ports 362 may connect tube 352 to the interior of section 302, such that fluid (e.g., disinfectant, water, cleaning agent, or air) input through at least the first inlet 324 may exit from port 362, preferably as a powerful jet, and enter the interior of the box. Ideally, the number of outlet ports exceeds the number of inlets. Thus, for example, there may be one or two inlet ports, and four to twelve outlet ports. Figure 7 and 8 As shown, the manifold includes one inlet port and eight outlet ports. Finally, it may include an exhaust port 349.

[0037] Using the embodiments shown and described herein, the applicant has designed methods and variations thereof for sterilizing medical devices, particularly endoscopes, using an AER. For example, a reprocessing box, such as box 100, can be received in a closed configuration, for example... Figure 1 The box can be opened to an open configuration, for example. Figure 3 As reflected in the description, a medical device, such as an endoscope, can be placed in a portion of the housing, such as section 102. The lumen of the medical device can be connected to ports and valves via tubes (e.g., tubes 151, 153) through which fluid can be introduced into the housing and the medical device (e.g., ports 16, 118 and valves 124, 126). The housing can then be returned to a closed configuration. The housing can then be placed into and secured within the sterilization chamber of the AER. Alternatively, the housing can be placed into the sterilization chamber of the AER prior to any of the steps described above.

[0038] With the endoscope housed inside the case, after setting the case in a closed configuration within the sterilization chamber of the AER, the sterilization procedure can begin. The case can then be placed in the sterilization configuration, for example... Figure 2 or Figure 5As shown. That is, at least one panel (e.g., 108 or 112) of a component of the housing (e.g., 102 or 104) can be moved from a position where it contacts the housing (e.g., 106 or 110) of that component to a position where it does not contact the housing. This can be achieved by pulling the panel away from the housing, for example, by pulling or pushing the panel away from the housing. The panel can be pulled away from the housing by first engaging a fluid delivery assembly (e.g., 132) with a mating feature (e.g., slots 134 and 136) of the panel. The fluid delivery assembly can then be removed from the housing, thereby pulling the panel along with it. Pistons (e.g., 172, 178) can help guide the panel; the pistons are connected to the panel and disposed within a cylinder (e.g., 172, 180), which is connected to or integral with the housing. The panel can be pushed by the fluid delivery assembly or returned to contact the housing by the force generated by one or more springs (e.g., 178) disposed around one or more pistons in a piston extending by displacement. Furthermore, one or more cylinders in the cylinder may include stepper motors, etc., to push and pull the panel between a closed configuration and a sterilization configuration. When the box is in sterilization configuration, various fluids (e.g., cleaning agents, disinfectants, water, and air) can be introduced into the box and the medical device to clean, sterilize, and dry them. This fluid can be introduced into the box via the space between the panel and the housing, for example by fluid delivery assembly 146, or through a port provided through the panel, for example by fluid delivery assembly 132. The box 100 can then be returned to the closed configuration. The reprocessing procedure can be ended, and the box can be removed from the AER. The box can then be stored together with the sterilized medical device inside.

Claims

1. A reprocessing box, comprising: The first section includes, The first housing has a first cylinder. A first panel is connected to a first piston, which is at least partially disposed within the first cylinder; The first port is set through the first panel; and A first valve is installed through the first port; The second section includes a second housing and a second panel; A hinge connecting the first housing to the second housing, wherein the first panel contacts the first housing to define a closed configuration of the reprocessing chamber; and A fluid delivery assembly, connected to the first panel, such that, in the closed configuration, the fluid delivery assembly enables the first panel to move away from the first housing in a first direction, and prevents the first panel from moving toward the second housing in a second direction opposite to the first direction.

2. The reprocessing box according to claim 1, wherein the first panel is angled outward from the first housing.

3. The reprocessing tank according to claim 1, further comprising a first pipe connected to the first valve.

4. The reprocessing chamber of claim 3, wherein the second housing further comprises a second cylinder, and the second panel includes a connection to a second piston at least partially disposed within the second cylinder.

5. The reprocessing chamber according to claim 4, wherein the second panel comprises: The second port is set through the second panel; and A second valve is installed in the second port.

6. The reprocessing chamber of claim 5, wherein the second panel contacts the second housing.

7. The reprocessing chamber of claim 5, wherein the second panel is displaced from the second housing and does not contact the second housing.

8. The reprocessing chamber of claim 7, wherein the second panel is angled outward from the second housing.

9. The reprocessing tank according to claim 5, further comprising a second pipe connected to the second valve.

10. The reprocessing tank according to claim 1, further comprising a manifold.

11. The reprocessing chamber of claim 10, wherein the manifold is at least partially disposed on the first panel.

12. The reprocessing chamber of claim 10, wherein the manifold is integrated in the first section of the chamber.

13. The reprocessing tank of claim 10, wherein the manifold includes at least one inlet port and at least four outlet ports.

14. The reprocessing tank of claim 13, wherein the manifold includes one inlet port and eight outlet ports.

15. The reprocessing tank according to claim 13 further includes a discharge port.

16. The reprocessing tank of claim 13, further comprising a nozzle attached to at least one of the outlet ports.

17. The reprocessing chamber of claim 16, wherein the nozzle comprises a rotary nozzle.

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