Patent Publication Number: US-2022219936-A1

Title: Equipment for winding medical tubing

Description:
RELATED APPLICATIONS 
     The present application is a national phase of PCT Application No. PCT/IB2020/053491, filed on Apr. 14, 2020, which claims the benefit of EP Application No. EP19169329.0, filed Apr. 15, 2019and EP Application No. EP19179055.9, filed Jun. 7, 2019. The entire contents of these applications are incorporated herein by reference. 
    
    
     TECHNICAL DOMAIN 
     The present invention discloses an equipment for winding medical tubing employing automated and sequentially-arranged workstations, which can be operated simultaneously. 
     STATE OF THE ART 
     Flexible plastic tubing is produced for a variety of sectors, ranging from engineering (automotive, aerospace), agriculture, horticulture and water management, plumbing, hydraulics, oil and gas, as well as the medical and healthcare. The specifications of the tubing, such as dimensions, material and its chemical and physical properties, are adapted to its specific use, whereby a coiled or wound assembly of the tubing generally eases the packaging, transport, use and manipulation of the tubing. To this end, different types of coiling machines, mostly employing motorised rotating reels, have been developed for industrial tubing and are available on the market today. 
     Yet, for the medical sector large-scale automated winding of medical tubing remains an unmet need, with medical tubing still primarily being wound by hand. Apart from the limitations in processing speed and the increased risk of contamination which come with the manual handling of the tubing, inconsistencies in winding and waste of material due to mis-manipulation of the tubing are more likely to occur when compared to an automated process. 
     Many medical devices include plastic tubing for fluid or gas transfer, Such medical tubing must comply with international norms and display adequate quality requirements concerning its sterility, performance, ingredients, etc. 
     In its practical application medical tubing is handled by medically-trained professionals, but also by untrained patients. For both user groups a simple and safe manipulation of the medical tubing without the risk of causing damage or entanglement of the tubing, is adamant. In order to mitigate these risks, it is critical to provide the tubing in a suitably organised state, such as a wound or coiled state. 
     To this end, several solutions for winding medical tubing have been developed employing desk top equipment, by way of example: http://www.medicalsysforindustry.com/custom%20tube%20coilers.html. However, these solutions are extremely limited in their processing rate and are therefore primarily useful for individual laboratories, but not suited for large-scale industrial operations. 
     CN108313424 describes an automatic winding and bagging mechanism for a medical catheter. The automatic winding and bagging mechanism comprises a rack, a catheter winding mechanism and a bagging grinding device, and the catheter winding mechanism and the bagging grinding device are sequentially arranged on the rack. The throughput of this mechanism is limited. 
     US2018008798 discloses a device for holding coils of medical tubing to simplify packaging and handling thus making it easier for patient to manipulate each coil of tubing and reducing the probability of entanglement. This solution is particularly suited to organize medical tubing conveying medical fluid in connection with dialysis machines, as it simplifies the handling of the tubing in a clinical or in a domestic setting. However, this method does not provide a solution for winding large volumes of medical tubing at industrial scale. 
     CN108313424 relates to an automatic winding and bagging mechanism for a medical catheter. The equipment comprises a rack, a catheter winding mechanism and a bagging grinding device. The catheter winding mechanism comprises a workbench, a catheter clamping assembly, a winding disc, a catheter pressing assembly, a catheter containing box and a pushing device. 
     DE3523848 discloses a device for winding and cutting, in particular medical tubes, with a rotating body to which a clamp and guide for fixing the tube to be wound are attached. The rotating body is rotated in such a way that the tube can be wound and cut to different lengths with an adjustable winding circumference. 
     The medical catheter winding device disclosed in CN103523560 provides a solution to ensure tight and firm winding of the catheter. It comprises a tensioning mechanism for enabling the catheter to be kept in a tight state when the catheter is wound. 
     EP1452474 discloses a method for the automated production of bobinless cable coils, wherein the cable strands can be predetermined in their length and are drawn off a cable reel. Each cable strand is wound to a coil and fixed in this form. 
     U.S. Pat. No. 6,135,164 describes an apparatus for preparing and positioning U-shaped loops of wires on a conveyor of a harness making machine. The invention employs vertically moveable transfer grippers to transfer the wire loops from the cutting station to the grippers of the conveyor. 
     The advantage of providing medical tubing organized in a wound state is further emphasized in document US2013/0006226 describing a compact catheter assembly, whereby the wound state of the catheter enhances its safe use, thus preventing hygiene-related medical issues. 
     None of the approaches provided today provides a satisfactory solution for safe, industrial-scale winding of medical tubing at a high and adjustable processing rate. 
     BREIF SUMMARY OF THE INVENTION 
     One objective of the present invention is to provide an equipment for winding medical tubing which is adapted for industrial-scale manufacturing, thereby increasing efficiency of winding medical tubing. 
     Another objective is to propose an equipment for winding medical tubing which is capable of operating in a controlled environment, thereby reducing the risk of contamination. 
     According to one aspect, those objectives are achieved by providing an equipment for winding medical tubing, employing a plurality distinct operational units performing automated tasks and which are capable of operating simultaneously comprising:
         (i) one or more conveying units arranged for conveying medical tubing to one or more bending units;   (ii) one or more said bending units arranged for bending medical tubing in a U shape;   (iii) one or more loading units adapted for individually picking and transporting each medical tubing after its bending from the bending unit to the winding unit;   (iv) one or more winding units for winding medical tubing, comprising a winding nest arranged for receiving medical tubing from said loading unit, and a winding module adapted for winding medical tubing after its deposition into said winding nest;       

     The equipment for winding medical tubing may furthermore comprise:
         (i) one or more unloading units adapted for individually picking and transporting each medical tubing after its winding from said winding unit to a packaging unit;   (ii) one or more packaging units for packaging each tubing after its winding, said packaging units capable of receiving the wound medical tubing from said unloading unit and employing a sliding cover plate for maintaining medical tubing in its wound state.       

     According to another aspect, said one or more operational units can be arranged and combined with other operational units in sequentially arranged and simultaneously operating working stations, including
         (i) one or more preparation stations each comprising said conveying unit(s)s said bending unit(s); and/or   (ii) one or more winding stations for winding medical tubing, each comprising said winding units) arranged on a winding station plate;       

     This equipment effectively solves the above-mentioned problems of the prior art with automated, sequentially-arranged units and sequentially arranged workstations which can operate simultaneously and are adapted for industrial-scale manufacturing to match a specific production line speed, thereby increasing efficiency and safety of winding and packaging medical tubing. 
     Each workstation can comprise a plurality of units in parallel and/or serial arrangement. 
     The number of units of each type might be increased to improve the through put. 
     The number of workstations of each type might be increased to improve the throughput. 
     The number of units and/or workstations of different types might be different. For example, the number of slow units with a low throughput might be higher that the number of fast units with a higher throughput. 
     Different units and/or units of the same type might be mounted in parallel. For example, the equipment might comprise a plurality of bending units in parallel, and/or a plurality of winding units and/or winding stations in parallel. 
     Workstation of the same type may be mounted in parallel arrangement. Workstation of different types may be mounted in serial arrangement. 
     Optionally, the equipment may further comprise one or more said packaging units for packaging each tubing after its winding, said packaging units. 
     The arrangement of the units permits the equipment to operate efficiently and at a high and adjustable throughput rate due to the following favourable aspects:
         (i) The process is fully automated, and   (ii) a plurality of each workstation as well as a plurality of each unit can be employed, and   (iii) the units of the workstations are capable of operating simultaneously   (iv) the processing speed of each unit and the number of each unit and workstation can be optimised to achieve a favourable throughput rate.       

     Advantageously, in the bending unit the medical tubing is arranged in a “U”-shape with optimal dimensions for the winding process in the winding unit. 
     As a further advantage, the ratio between the number of bending units, the number of loading units and the number of winding stations can be optimised to achieve efficient and smooth operations as well as a favourable throughput rate. 
     Furthermore, this advantageous “U”-shape is maintained by the loading unit throughout the transfer of the medical tubing to the winding unit. The disposition of the medical tubing in said “U” shape which is adjusted to the dimension of the winding unit permits consistent and rapid winding without straining or damaging the medical tubing. 
     Advantageously, the distal end of the tubing is received below the plate of the winding station by rotatable jaws, which are connected to and rotating with the winding module, permitting winding of the medical tubing around the vertical axis of the winding module, thus facilitating a favourable compact arrangement of several winding units. 
     As an additional advantage, the rotatable jaws are operated by fixed jaw grippers which are actuated by an independent motor, thus permitting the rotatable jaws an unlimited range of freedom. 
     The rotatable jaws favourable perform a rotating movement along the vertical axis of the winding module together with the rotating winding core, which is actuated by a motor. 
     For the duration of the automated winding of the medical tubing around the axis, tube jaws favourably keep the tube positioned within the winding nest and below the level of the winding station plate. 
     The wound medical tubing is advantageously raised along the vertical axis to the level of the winding station plate in a controlled movement preventing the tubing from being compressed or damaged and presented to the grippers of the unloading unit which optionally transfer the medical tubing to the packaging unit. 
     Advantageously, the ratio between the number of winding stations, which may contain a plurality of winding units, and the number of the unloading units can be optimised to achieve efficient and coordinated operations as well as a favourable throughput rate. 
     Once the medical tubing has been placed in the packaging container a cover plate is advantageously positioned over it in an automated gliding movement, which prevents the unwinding of the wound medical tubing. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Examples of the practical implementation of the invention are disclosed in the description and illustrated by the attached figures of which: 
         FIG. 1  is a schematic representation of the modular organisation of the operational units and workstations. 
         FIG. 2A  is a schematic representation of the preparation station; 
         FIG. 2B  is a perspective view of the bending unit lever indicating the direction of its automated movement; 
         FIG. 3  is a top view of the preparation station, identifying the conveying unit and the bending unit; 
         FIG. 4  is a schematic representation of the winding station; 
         FIG. 5  is a perspective view of a winding unit from above the winding station plate, comprising the winding nest and the winding module; 
         FIG. 6  is a perspective view of the winding unit from below the winding station plate; 
         FIG. 7A  is a side view of the winding module 
         FIG. 7B  is a top view of the winding module 
         FIG. 7C  is a perspective view of the winding module 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention describes an equipment for automated winding of medical tubing employing sequentially arranged operational units and workstations, comprising a plurality of units. A first workstation  1 , called preparation station, comprises at least one conveying unit  2  and at least one bending unit  3 . A second workstation  5 , called winding station, comprises at least one, but preferably a plurality of winding units  24 . One or more loading units  4  connect the operational processes of the preparation station  1  to the winding station  5 . One or more unloading units  6  connect the operational processes of the winding station  5  to a packaging unit  7 . 
     The equipment of the present invention is configured to wind different type of medical tubing  10 , such as but not limited to catheters, dialysis tubing, fluid management (drainage), respiratory equipment, biopharmaceutical equipment and others. 
       FIG. 1  exemplifies an arrangement of the equipment comprising a preparation station  1 , a loading unit  4 , two winding stations  5 , an unloading unit  6  and a packaging unit  7 . The preparation station  1  comprises a conveying unit  2  configured to dispose medical tubing  10  ( FIG. 2 ) into three bending units  3 . The medical tubing  10  ( FIG. 2 ) might be transferred by the loading unit  4  servicing two separate winding stations  5  comprising each three of winding units  24 , each comprising a winding nest  16  ( FIG. 4 ) and three winding modules  17  ( FIG. 4 ). The unloading unit  6  might be configured to alternatingly remove medical tubing  10  ( FIG. 2 ) from two winding stations  5  and transfer it to the packaging unit  7 , The above-mentioned numbers of workstations and different units are intended to be an example and can be varied according to specific needs. 
     Optionally, the loading unit  4  and the unloading unit  6  might be equipped with sensors able to detect, if a receiving cavity, such as the winding nest  16  ( FIG. 4 ) or the packaging container, is unloaded before the deposition of the medical tubing  10   
     ( FIG. 4 ) in either the receiving cavity, thus enabling the equipment to operate in a highly coordinated and efficient manner. 
     Optionally, the winding station  5  might be moved from proximity of the preparation station  1  to proximity of the packaging unit  7  during the winding process in order to minimise the transfer distances of the medical tubing  10  and to increase efficiency of the process. 
       FIG. 2A  illustrates the possible composition of a preparation station comprising a conveying unit  2  and three sequentially arranged bending units  3  and parts of the loading unit  4  with its tube grippers  12 .  FIG. 2B  illustrates the binding unit lever  13  in two possible positions, wherein its rotating movement performed to stretch the bent medical tubing  10  is indicated by arrows. 
     As shown in  FIGS. 2A and 2B , the ends of the medical tubing  10  are fastened by end grippers  8  of the bending unit  3  and arranged in a “U” shape with the aid of two open end grippers  14  located next to the end grippers  8  and a lever  13 , which moves the middle section of the medical tubing  10  in the opposite direction of its ends. The distance between the end grippers  8  configured to fasten the medical tubing  10  and the lever  13  can be adapted to suit the length of the medical tubing. 
       FIG. 3  illustrates the preparation station  1 , in which the medical tubing  10  is delivered to the binding unit  3  by the conveying unit  2 , which employs end grippers  8  ( FIG. 2A ) to fasten the ends of the medical tubing  10 . 
     The medical tubing  10  is received in its “U” shape by the loading unit  4  ( FIG. 1 ), which comprises a plurality of grippers to transfer and subsequently dispose the medical tubing  10  in its maintained “U” shape in the winding nest  16  of the winding station  5 , which is depicted in  FIG. 4 . For each piece of medical tubing  10 , the loading unit  4  ( FIG. 2A ) employs two end grippers grasping the ends of the medical tubing and one tube gripper  12  ( FIG. 2A ) grasping the middle section of the medical tubing. The plurality of grippers is adjusted to suit the plurality of bending units  3  and the plurality of winding stations  5 . The loading unit  4  ( FIG. 1 ) can transfer medical tubing  10  to a plurality of winding stations  5  ( FIG. 1 ) in an alternating manner. 
     The medical tubing : 10  is configured to be positioned in the winding nest  16 , shown in  FIG. 4 , which is milled into a winding station plate  15 , whereby the distal end of the medical tubing is lowered into a descending groove  20  as shown in in  FIGS. 7  A to C. The ends of the medical tubing are fastened by a fixed gripper  22  at the level of the winding station plate  15  and by rotatable jaws  18  ( FIG. 5 ), which are actuated by fixed jaw grippers  23  ( FIG. 5 ) and positioned below the winding station plate  15 . 
     In a subsequent step, the medical tubing  10  is wound vertically around the winding core  19  of the winding module as shown in  FIGS. 7  A to C, whereby the rotatable jaws  18  clasping one end of the medical tubing are attached to and perform the rotating movement with the winding module  17 . 
     The winding of the medical tubing  10  around the vertical axis of the winding core  19 , as opposed to horizontal coiling in a disc-like shape, facilitates a compact arrangement with several winding units  24  in parallel, as shown in  FIG. 4 . 
     During the automated winding of the medical tubing around the winding core  19 , tube jaws  2 : 1  ( FIG. 5 ), which are connected to the winding station plate  15  and can be moved into close proximity of the winding core  19  and away from it in a rotating movement, keeping the medical tubing positioned within the winding nest  16  and below the level of the winding station plate  15 . 
     The wound medical tubing is raised to the level of the winding station plate  15  ( FIG. 5 ) and received by the unloading unit  6  ( FIG. 1 ), which employs a plurality of grippers suited to the number of medical tubing to be transferred. The unloading unit  6  subsequently transfers the medical tubing to the packaging unit  7  ( FIG. 1 ). 
     Upon release and deposition of the medical tubing in the packaging container, a sliding cover plate is moved onto the packaging container in a gliding movement in order to prevent the wound medical tubing from unwinding. 
     REFERRENCE NUMBERS USED IN THE FIGURES 
     
         
           1  Preparation station 
           2  Conveying unit 
           3  Bending unit 
           4  Loading unit 
           5  Winding station 
           6  Unloading unit 
           7  Packaging unit 
           8  End grippers 
           9  Bending station plate 
           10  Medical tubing 
           11 Alternative lever position adjusted to length of tubing 
           12  Tube gripper 
           13  Lever 
           14  Open end grippers 
           15  Winding station plate 
           16  Winding nest 
           17  Winding module 
           18  Rotatable jaws 
           19  Winding core 
           20  Descending groove 
           21  Tube jaws 
           22  Fixed grippers 
           23  Fixed jaw grippers 
           24  Winding unit