Abstract:
A system for reprocessing contaminated medical instruments includes at least one reprocessing unit, the reprocessing unit being adapted to perform the reprocessing of at least one of a predetermined type of contaminated medical instrument. The system also includes an electronic controller including a user input device, an electronic processor, associated memory, and an operating system capable of being run on the processor. The controller is operably coupled to the reprocessing unit to enable control of the operation of the reprocessing unit. A control program for the controller for disposition in the memory is provided. The control program establishes at least one protocol of processing steps for effecting the reprocessing of the medical instrument in the reprocessing unit. A monitor provides a visual display of various operating conditions of the system.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    This invention relates generally to a system for the reprocessing of a contaminated device having internal passageways before such a device is reused in a clean environment. The term “reprocessing,” as used herein constitutes the washing, disinfecting, sterilizing and/or pasteurizing of such a device. The term “device” as used herein constitutes any devices having internal passageways that require such reprocessing, including, but not limited to, medical instruments and medical devices. The terms “medical instrument” and “medical device” are understood to constitute devices having one passageway or a plurality of passageways, including, but not limited to endoscopes, colonoscopes, and other flexible and rigid medical instruments. 
         [0002]    Some automated systems for reprocessing devices having internal passageways for reuse are generally available and are commonly relied upon. For example, systems for reprocessing medical instruments having passageways are used by hospitals to safeguard patients and hospital employees from exposure to infection and cross-contamination. Such systems are manufactured by several different companies including, Custom Ultrasonics, Inc., of Ivyland, Pa., the assignee of the present invention and application. For example there are reprocessing units in the prior art adapted for cleaning, disinfecting and sterilizing flexible scopes, e.g., upper and lower gastrointestinal scopes, colonoscopes and duodescopes. 
         [0003]    Prior art reprocessing systems, suitable in particular for reprocessing medical instruments, operate in accordance with a predetermined protocol of reprocessing steps. The protocol is based upon the specific cleaning requirements of the particular instruments being cleaned. The reprocessing steps are precisely timed and sequenced in order to assure optimal results, based upon the correct combination of water temperature, detergent and chemical agents. Thus, parameters such as wash and rinse cycle time, chemical immersion cycle time and water temperature and pressure were preset by the reprocessing unit manufacturer and could not be altered by an end user of the system. U.S. Pat. No. 5,761,069, issued to Weber, et. al. teaches a system for cleaning medical instruments having a database of protocols corresponding to differing medical instruments for permitting a user to load and execute the protocol corresponding to the instrument being reprocessed. 
         [0004]    An exemplary protocol for cleaning a medical instrument could include the following reprocessing steps, after the instrument has been placed in the cleaning basin of the reprocessing unit: (1) wash the internal and external surfaces of the instrument with a measured detergent-water mixture for a preset period of time; (2) activate ultrasonic crystals while washing; (3) drain the detergent-water mixture after the wash cycle is completed; (4) after draining, rinse the internal and external surfaces of the instrument with water at a preset temperature for a preset period of time; (5) introduce and circulate disinfectant over and through the instrument for a preset period of time; (6) drain the disinfectant from the wash basin; and (7) after draining of the disinfectant is complete, rinse the instrument with water; and (8) re-rinse the instrument with water. 
         [0005]    One current reprocessing system uses a computer that runs on a DOS system. A user may activate such reprocessing system simply by turning the system on and directing the reprocessing system to execute a particular reprocessing protocol. Although this may be convenient for the user, it does not prevent an unauthorized user from accessing and using the system. Additionally, since the system&#39;s computer does not recognize which user is accessing the system, there is no way to track which user operated the system at a particular time. Although current systems are largely automated, there are instances in which human error can play a role in inadequate or ineffective reprocessing of a medical instrument. Therefore, there is a need for a reprocessing system which can only be activated and operated upon a user&#39;s entering of information, e.g., a password, into the computer, which uniquely identifies the specific user. Moreover, concerns of security and accountability give rise to a need for a system which can store data identifying which user ran which reprocessing cycle on a particular instrument. 
         [0006]    Current reprocessing systems are not adaptable to be linked into a local area network, such as that in a hospital. There is a need for data associated with the running of a reprocessing cycle to be transferred over a network, so that such data may be easily accessed by other people, such as a nurse administrator. Such data might include, for example, the name of the user of the reprocessing system, the identity of the specific instrument(s) reprocessed during a particular reprocessing cycle, the name of the patient(s) on which the instrument(s) was used and the name of the doctor(s) who used the instrument(s). In the unfortunate event that a patient is infected by one of the reprocessed instruments, it would be helpful for information regarding the reprocessing sequence of that instrument to be readily available over the network. This would improve patient care since those users who do not run reprocessing cycles properly could be held accountable. 
         [0007]    When a user of a current reprocessing system is having trouble using the system or if the system appears to be malfunctioning, the user often contacts the manufacturer and/or distributor of the system by telephone to obtain technical assistance. When this is done, the user must verbally describe the problem and what he/she sees on the display screen of the system. In some cases, this process can be inefficient and unnecessarily time consuming. There is therefore a need for the manufacturer and/or distributor to have remote access to the particular system, so that the manufacturer and/or distributor could view the visual display on the system&#39;s monitor and control the system, thereby more efficiently and effectively assisting the user. 
         [0008]    At times, the system configuration settings of reprocessing systems are accessed in order to reconfigure system parameters. This task is generally not done by medical facility staff, but rather, by representatives of the manufacturer and/or distributor of the system. In order to ensure that persons other than manufacturer and/or distributor representatives do not have access to system configuration settings (one concern being that the system may be improperly reconfigured so as to ineffectively reprocess instruments), current systems generally have a password for such access, intended to be known only by certain manufacturer and/or distributor personnel, e.g., representatives. For example, one such system currently has a permanent three-digit password with which one can gain access to system configuration settings. However, a permanent password, or even one that is only changed occasionally, may at some point be learned by those not intended to have access to the system configuration settings. There is a need, therefore, for greater security to prevent unintended users from having access to system configuration settings. 
         [0009]    Current systems generally employ a liquid disinfectant (or liquid chemical germicide) to be used in the reprocessing of instrument(s). These systems have compartments or reservoirs for storage of the disinfectant so that it can be used upon initiating a reprocessing sequence. Some liquid disinfectants must be maintained within a particular temperature range, or else they may lose their effective properties. When the system is shut down, e.g., at night or on weekends, the first user to initiate the system currently has no way of knowing whether the disinfectant stored within a compartment of the system has been consistently maintained at an appropriate temperature. It is therefore the general practice to simply dispose of the disinfectant stored within the system after the system has been shut down. Disinfectant can be expensive and therefore there is a need to prevent any unnecessary waste of disinfectant stored within compartments of reprocessing systems. 
         [0010]    There is also a need for a reprocessing system with software capable of threading, i.e., directing more than one function of the reprocessing system at one time. 
       SUMMARY OF THE INVENTION 
       [0011]    A system for reprocessing contaminated medical instruments includes at least one reprocessing unit, the reprocessing unit being adapted to perform the reprocessing of at least one of a predetermined type of contaminated medical instrument. The system also includes an electronic controller including a user input device, an electronic processor, associated memory, and an operating system capable of being run on the processor. The controller is operably coupled to the reprocessing unit to enable control of the operation of the reprocessing unit. A control program for the controller for disposition in the memory is provided. The control program establishes at least one protocol of processing steps for effecting the reprocessing of the medical instrument in the reprocessing unit. A monitor provides a visual display of various operating conditions of the system. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0012]    The invention will be described in conjunction with the following drawings in which like reference numerals designate like elements and wherein: 
           [0013]      FIG. 1  is an elevational view of a reprocessing unit suitable for use with the present invention. 
           [0014]      FIG. 2  shows a top view of the reprocessing basin of the reprocessing unit of  FIG. 2  including a device to be reprocessed. 
           [0015]      FIG. 3  show a flow chart representation of a process for use with the system and method of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]    Referring now to  FIGS. 1 ,  2 , there is shown a reprocessing system  80  suitable for use with the present invention, and a view of a reprocessing basin  12  (a.k.a. processing chamber) within the reprocessing system  80 . Custom Ultrasonics, Inc., of Ivyland, Pa., the assignee of the present invention and application, is the manufacturer of the System  83  Plus and MiniFlex, both of which are embodiments of the system  80  of the present invention. 
         [0017]    The reprocessing basin  12  holds a device  96  having internal passageways  98   a - e  for reprocessing of the device  96  by the reprocessing system  80 . In a preferred embodiment of the invention, the device  96  being reprocessed by the reprocessing system  80  can be a medical instrument  96 . In particular, the system and method of the invention are well suited for application to medical instruments including flexible scopes such as endoscopes that are used for upper and lower gastrointestinal studies, bronchoscopes, cystoscopes, and ENT, urology and gynecology flexible endoscopes. 
         [0018]    The reprocessing system  80  includes a keyboard  40 , a monitor  28 , a printer  32 , and an associated personal computer (not shown) for permitting a user of the reprocessing system  80  to communicate with and control the reprocessing system  80 . The reservoir  16  of the reprocessing system  80  includes the sensors  34 ,  36 ,  38  for controlling devices such as a heater, a pump and a vacuum device (not shown) in order to protect against failure conditions such as overflow conditions in the reservoir  16 . A removable door  42  within the reprocessing basin  12  covers additional sensors (not shown) for providing further operational capability and safety protection during the operation of the reprocessing system  80 . The door stops  30  are provided to stop the motion of the rotatable doors  31  covering the reservoir  16  and the reprocessing basin  12  when they are opened. 
         [0019]    In a preferred embodiment, the reprocessing basin  12  can hold more than one device  96  upon a mesh for reprocessing of the internal passageways  98   a - e  thereof according to conventional reprocessing protocols. The reprocessing system  80  is adapted to provide fluid flows of differing pressures to the device  96  or devices  96  being reprocessed when the internal passageways  98   a - e  have differing diameters. The reprocessing system  80  is adapted to perform the multi-pressure reprocessing operations using a single pump (not shown), and to provide an indication of an obstruction in any of the internal passageways  98   a - e  of the device or devices  96  as described in more detail below. The single pump of the reprocessing system  80  can be a diaphragm pump, an oscillating pump, or any other type of pump known to those skilled in the art. 
         [0020]    The reprocessing basin  12  includes the supply ports  123   a - 1  that can be selectively used to apply fluids at different fluid flow rates to the medical instruments  96  for reprocessing of the medical instruments  96 . For example, the supply port  123   j  can be capped and reserved for use when needed. The supply port  123   a  can be used to blow off a fluid flow which is unusable due to difficulty in regulating and measuring their flow rates, as described in more detail below. In this example, at least the supply ports  123   a - 1  that are not capped or blown off can be vented into the reprocessing basin  12  or coupled to the internal passageways  98   a - e  of a medical instrument  96  as needed. 
         [0021]    For example, an internal biopsy passageway  98   a  of the medical instrument  96  can be coupled to the supply port  123   b  by way of the tubing segment  132   b , and an internal water channel passageway  98   b  of the medical instrument  96  can be coupled to the supply port  123   c  by way of the tubing segment  132   c . The internal passageway  98   c  can be coupled to the supply port  123   d  by way of the tubing segment  132   d , and the internal suction passageway  98   d  can be coupled to the supply port  123   e  by way of the tubing segment  132   e . The internal elevator water channel passageway  98   e  can be coupled to the supply port  123   l  by way of the tubing segment  132   l . Typical diameters for some of the passageways  98   a - e  can be 0.508 millimeters to 4.8 millimeters. 
         [0022]    In one embodiment of the present invention (not shown), the computer of the reprocessing system  80  has stored within its memory data identifying at least one potential user of the system  80 . Any and all potential users of the reprocessing system  80  are assigned a unique username and password to access the system  80 . The system cannot be activated and a reprocessing sequence cannot be run without a user entering his/her username and password. Additionally, when a user enters a username and password, the computer or another electronic data storage device records the identity of the user who activated the system  80  and/or ran a reprocessing sequence. In this way, a record is maintained as to which user ran which reprocessing sequence. Although entering of a username and password is a preferred way to identify which user ran which sequence, there are many other possibilities as to how this may be achieved. For example, a user may be assigned a user identification card which has a magnetic strip, a bar code, a RFID tag or a RFID reader, or biometric data, which may be read by an input device operably connected to the computer. One advantage to requiring a user to identify himself/herself prior to accessing the system  80  is for security purposes, i.e., to ensure that only those persons intended to have access to the system  80  have access. Another advantage is that users who do not operate the system  80  properly may be held accountable. This improves patient service because patients may be at risk of contracting an infectious disease as a result of a medical device used on the patient which was not properly reprocessed. 
         [0023]    In a related embodiment of the present invention (not shown), in addition to user identification data being recordable on an electronic data storage device, other data related to the reprocessing of the instruments may also be recorded onto the electronic data storage device. Such data may include data identifying the specific instrument that underwent reprocessing, data identifying the patient on which the instrument was used, data identifying the physician who conducted a procedure with the instrument, data regarding the temperature of the disinfectant used during reprocessing and data regarding the type of disinfectant used during reprocessing. 
         [0024]    In another embodiment of the present invention (not shown), the computer of the reprocessing system  80  is part of a local area network, which allows the computer to transfer data associated with the reprocessing of instruments to other computers within the network. For example, the data generated in conjunction with the running of a reprocessing sequence may be transferred via the network to the computer of a nurse administrator or another hospital employee. 
         [0025]    In another embodiment of the present invention (not shown), the computer of the reprocessing system  80  is accessible and operable by a remote user, such as the manufacturer and/or distributor of the system  80 . In the event that a user is having difficulty using the system  80  or the system  80  appears to be malfunctioning, the manufacturer and/or distributor may remotely access the computer of the system  80  for purposes of troubleshooting and assisting the user. 
         [0026]    In another embodiment of the present invention (not shown) the system&#39;s computer has system configuration settings stored in its memory. The settings store parameters of reprocessing protocols, for example, wash and rinse cycle time, chemical immersion cycle time and water temperature and pressure. If these parameters are improperly altered, it may render a reprocessing protocol ineffective, thereby detracting from the integrity of the system  80  as programmed and configured by its manufacturer and/or distributor. Therefore, in one embodiment of the present invention, the system configuration settings may be accessed only by entering a special password into the computer. It is intended that the password should not be known by users of the system  80 , but rather, preferably by representatives of the manufacturer and/or distributor. Moreover, the password is changed periodically in order to prevent its dissemination to unintended users. In a preferred embodiment, the password is changed daily. For example, the manufacturer and/or distributor of the system  80  may actively change the password. Alternatively, the manufacturer and/or distributor of the system  80  would have access to an algorithm-generated password. In either case, if a representative of the manufacturer and/or distributor is at the site of a particular system  80 , the representative may contact the manufacturer and/or distributor in order to obtain the appropriate password for that particular system  80  at that particular time. Upon obtaining the appropriate password, the representative may access the system configuration settings in order to make any desired changes. It is also preferred that the password not be short in length, but rather, it should be several characters long, e.g., twelve characters. 
         [0027]    In another embodiment of the present invention (not shown) the computer of the system  80  provides the user with threading capabilities, i.e., to allow the user to operate more than one function of the system  80  at one time. 
         [0028]    In another embodiment of the present invention (not shown) the system  80  further includes a compartment for storage of liquid disinfectant used for reprocessing medical instruments. Disinfectants often must be stored within a particular temperature range, or else they may lose their effectiveness. Therefore the compartment includes a temperature sensor to measure the temperature of the disinfectant. The compartment further includes a temperature regulator, e.g., a heater, to maintain the temperature of the disinfectant at a desired level. In one embodiment, measurements from the temperature sensor are periodically communicated to and stored in the computer of the system  80 , or alternatively to another electronic data storage device. Temperature sensor measurements would preferably be communicated every 0.2 seconds to 10 minutes, and even more preferably every 1 to 5 seconds. A record of the temperature of the disinfectant could thereby be maintained, to ensure that the temperature was adequate at all times for the particular disinfectant. Additionally, the temperature regulator and sensor would continue to function even when the system  80  is not activated, is in “sleep mode”, when the monitor  28  displays a “screen saver”, and/or when the system is otherwise off (preferably, the system  80  is left on 24 hours a day, 7 days a week). In this way, even when the system  80  is inactive, e.g., during nights and weekends, users would be assured that the disinfectant in the compartment was maintained at an appropriate temperature at all times. This would obviate the need to dispose of the disinfectant before running a new reprocessing sequence. 
         [0029]    In another embodiment of the present invention (not shown) the computer of the system  80  monitors and controls the temperature of disinfectant and water used during the reprocessing of a medical instrument. 
         [0030]    In yet another embodiment of the present invention, upon completion of a reprocessing sequence, the printer  32  would automatically print information pertinent to the operations of the system  80 , or any other information stored on the computer&#39;s memory. Such information may relate to one or more of the following reprocessing parameters: date and time of initiating the system  80 , model and serial number of the medical instrument(s) which underwent reprocessing, physician name, patient name, technician name, detergent name, disinfectant name, time the reprocessing sequence started, wash time, rinse time, disinfectant time, temperature of the disinfectant, first rinse time, second rinse time, third rinse time, time the reprocessing sequence was completed and total time duration of the complete reprocessing sequence. In a related embodiment, in the event the printer  32  malfunctions or there is not a proper connection between the printer  32  and the computer, the problem would be communicated to the user, e.g., in the form of a dialogue box on the screen of the monitor  28 . Failure to document and print-out these reprocessing parameters and include this documentation in the patient&#39;s medical file may hinder an investigation in the event an infection or outbreak is identified. Thus, optimally, the system  80  would be unable to run a reprocessing sequence unless and until such information, or some of such information is entered into the computer. 
         [0031]    Referring now to  FIG. 3 , there is shown a flow chart representation of a process for use with the system and method of the invention. To perform this process a user can enter a username and a password into the computer of system  80  for the purpose of authentication. Accordingly, the user can view a main control screen, and use a main control screen to access to operate the system  80 . In addition to providing access to the system  80  the main control screen can offer the user access to options such as obtaining reports, going into a night mode, logging off or shutting down. In a preferred embodiment the system is connected to a local area network, such as a hospital network, and to the internet. 
         [0032]    The user can then prepare and attach the scope to be reprocessed by the system  80 . Those skilled in the art will understand that the scope to be processed should be wiped down and that the insertion tube should be wiped down to remove lubricant and gross contaminants without exerting excessive pressure on bending rubber. The scope can be tested for leaks. Air, water and suction buttons can be removed and an appropriately sized cleaning brush can be passed through the suction/biopsy channel exiting at the distal tip and at the connector. The brush tip can be cleaned and removed. The user can clean the suction button housing and select and attach all appropriate instrument adapters for processing. A check can be made that all adapters are secure and the liquid can flow thorough all tubing. 
         [0033]    The user can then select the desired functions. For example the user can select wash, disinfect or purge function. Before the system  80  performs the requested function on the attached scope, a second entering of a username and a password can be required. Furthermore, additional entering of usernames and passwords can be required at any time during the process of  FIG. 3 . This requirement can help to identify which user initiates each process. It also helps to prevent or remedy any errors during the process. For example, if a user tries to empty disinfectant from the system  80 , adjust any parameters of the process, or start or stop a cycle during the process of  FIG. 3  a new entry of a username and password can be required. This can help protect the user, the system  80 , the scope, the hospital and the patient. 
         [0034]    Additionally, an embodiment made available to administrators, charge nurses and bio-med staff for checking and fixing medical equipment can include additional screens to provide additional functionality beyond the functionality available to other users. The additional functionality can include, for example, functions for adding or deleting users and physicians. 
         [0035]    Furthermore, any changes to the configuration of the system  80  can be restricted to the manufacturer or distributor of the system using usernames and passwords. Accordingly, the manufacturer or distributor can enter a user name and password at a remote location and change the configuration of the process as needed. The software controlling the operations of the system  80  can be modified or updated by the manufacturer or distributor from the remote location. The user can be notified prior to such updating and given the option of permitting the update to continue. For example, an option to perform a wash only function can be enabled or disabled from the remoter location. Additionally, any of the operations of the system  80  can be performed from the remote location. The username and password used by the manufacturer or distributor can be changed periodically in order to enhance security. 
         [0036]    Any required modifications and updating of the system  80  can be performed automatically on a periodic basis or on an as-needed basis. In one embodiment selected error detection algorithms performed by the system  80  can result in error messages to the user and to the manufacturer or distributor in order to permit the manufacturer or distributor to assist the user in correcting the error. The manufacturer or distributor can view operation of the system  80  from the remote location in response to automatically transmitted error messages or call for assistance from the user in order to further assist in correcting the errors. The manufacturer or distributor can also run diagnostic algorithms from the remote location. 
         [0037]    Operating system threading capabilities can be used to permit the manufacturer or distributor to monitor the activities of each individual machine bay within the system  80 , including the inputs, the outputs and the temperature of any elements of the system  80 . For example, the potency and temperature of the disinfectant can be monitored. The monitored parameters can all be monitored on a recurring basis, for example every three seconds. The results of all monitoring operations can be saved by the user or by the manufacturer or distributor. The results can be stored either on the system  80  computer or on a server located at a site operated by the manufacturer or distributor. 
         [0038]    The user can enter patient, physician, and scope information relevant to the reprocessing operation into the system  80 . As previously described, an individual entry of a username and password can be required in order to implement the entry of the patient or physician data. In a preferred embodiment all such information for a period of time, for example, for a period of a day, can be entered at one time. Patient information and physician information can then be adjusted as necessary during the period of time if needed. Thus, for example, if it is determined that a scheduled patient appointment is canceled the scope reserved for the patient can be removed. 
         [0039]    When the system  80  and the user are ready the reprocessing of the scope can begin, with or without a further entry of a username and password. During reprocessing, the system  80  can provide displays to the user and/or the remote manufacturer or distributor. For example, the system  80  can display information such as the number of cycles completed, the number of cycles remaining, the percentage of the total reprocessing time, and the input and output flows of all fluids used during the reprocessing. The displays can indicate the operation of the ultrasonics, pumps such as drain pumps, drain valves, water valves, oscillating pumps, reservoir pumps, reservoir returns, residual drains, and detergent pumps. The monitored and displayed information can include the automated injection of alcohol. Additionally, patient, physician and scope information can be displayed. The display of relevant information allows staff to identify instruments and perform other operations without touching and opening the door of the system  80 . For example, the user can check the model of the scope the within the system  80  by viewing the display or obtaining a printout. Thus, the user can obtain the information without incurring any risk of splashing or contamination. 
         [0040]    In one preferred embodiment the user can be permitted to enter notes at any time during the reprocessing operations. Notes, messages, or other information can be printed out by the user or by the manufacturer or distributor. The information can be printed out at the system  80  or at the location of the server of the manufacturer or distributor. The notes, monitored information, or any other information, can be saved in the system  80  database or the manufacturer or distributor server database. Furthermore, the information can be made available as part of reports on the reprocessing session. Operation of the process of  FIG. 3  can be terminated or returned to the beginning in order to perform further reprocessing. 
         [0041]    It will be understood by those skilled in the art that a client program running on a remote computer with encrypted data transmissions can permit an approved remote user, such as a facility manager, a unit manager, a nurse manager, bio-med personnel, etc., to produce any desired charts and reports based on data stored within the system  80  or at the server operated by the manufacturer. This can include remote administration and adding, editing and deletion of, but not limited to, endoscopes, physicians, employees and users. Product information, industry alerts, and marketing updates can also be received by the client program. The client program can contain, but is not limited to, up to date manuals, product brochures, parts, price listings, etc. 
         [0042]    The client program, back up database data, and any other reports and data may be transmitted over an encrypted connection. They may also be saved to a rewritable CD which is local to the computer running the client. Additionally, the system and method of the invention permits identification and logon by way of RFID, Wi-Fi based RFID technology, scanning employee cards or bar codes, and/or biometric based technologies. 
         [0043]    The channel monitoring performed by the invention can be completely integrated to permit every monitored channel to be controlled and monitored by the software implementing the process of  FIG. 3 . Therefore, obstructions and/or blockages in the instrument channels, adapters, and inline filters can be monitored. The monitored information can be logged at any remote location, any location within the local area network, or at any location connected to the internet. Furthermore, determinations of flow level below or above a predetermined range can be made from any location. The determinations can be performed using RFID technology, and they can be performed whether a scope adapter is connected or unconnected to the scope. They can also be performed whether the scope adapter is connected or unconnected to the system  80 . 
         [0044]    Any or all of the various aforementioned embodiments may be combined to form further embodiments of the present invention. While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.