Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
  • B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
  • B23P21/00—Machines for assembling a multiplicity of different parts to compose units, with or without preceding or subsequent working of such parts, e.g. with programme control
  • B23P21/004—Machines for assembling a multiplicity of different parts to compose units, with or without preceding or subsequent working of such parts, e.g. with programme control the units passing two or more work-stations whilst being composed
  • B23P21/006—Machines for assembling a multiplicity of different parts to compose units, with or without preceding or subsequent working of such parts, e.g. with programme control the units passing two or more work-stations whilst being composed the conveying means comprising a rotating table
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0009—Making of catheters or other medical or surgical tubes

Definitions

• the present invention concerns a machine for the assembly of medical devices.
• infusion catheters for the medical treatment of patients requiring fluid drainage, to administer medication, or for diagnostic purposes (generally used in dialysis treatment, controlled infusions of liquid solutions, etc. ).
• the infusion catheter in question basically comprises:
• first flexible tube having a first end and a second end
• a drip chamber for the controlled administration of a product; the chamber is connected to the first end of the first tube;
• - a second flexible tube having a first end connected to the second valve and a second end; - a connector, associated with the second end of the second tube, for the attachment of the device to medical instruments.
• first and the second flexible tube that are used can be of different diameters and variable lengths, depending on the use and purpose of the device.
• second connecting valve that is used can be of different functional types (Y valve, air separator, etc.) depending on the use and purpose of the device.
• the connector that is used can be of different types depending on the use and the type of medical instrument that is to be connected.
• semi-automatic machines are used that comprise a work plane that extends along a longitudinal axis, above or alongside of which single operating stations are located that carry out the positioning or assembly of a corresponding component of the catheter.
• Each operating station located along the work plane is connected to a supply receptacle for the assembly component in question, placed lateral to the work plane.
• the structure with the longitudinally extending work plane is an extremely unwieldy structure of considerable width and length, also in relation to the number of components that have to be assembled. With such a single line of operation the productivity of the machine in relation to the size of that machine is low.
• the machine with such a structure has less operational flexibility whenever it is necessary to modify the type of tube, valve or connector, which have to be replaced from time to time in the corresponding receptacles by an operator.
• the aim of the present invention is to provide a machine for the assembly of medical devices, such as infusion catheters, which overcomes the above- mentioned drawbacks. More particularly, the aim of the present invention is to provide a machine for the assembly of medical devices, such as infusion catheters, which is able to assemble the devices with speed and accuracy, but occupying much less space for its operation.
• Further aim of the present invention is to provide a machine for the assembly of medical devices, such as infusion catheters, which is able to increase productivity and that has higher operational flexibility, and in which the components can be substituted rapidly and easily, depending on production needs. Said aims are fully obtained by the machine for the assembly of medical devices, such as infusion catheters, of the present invention, which is characterised by the features as defined in the claims below.
• FIG. 1 illustrates a machine for the assembly of medical devices, such as infusion catheters, that is the subject of the present invention, in a perspective view with some parts removed in order to highlight others;
• FIG. 2 illustrates a rotating drum that is part of the machine of figure 1, in a perspective front view and with some parts removed in order to highlight others ;
• figure 3 illustrates the rotating drum of figure 2 in a perspective rear view with regard to figure 2 and with some parts removed in order to highlight others;
• FIG. 4 illustrates the components that together form an infusion catheter which can be assembled in the machine illustrated in the previous figures, and in a perspective view;
• FIG. 5 illustrates a part of the machine illustrated in figures 1 to 3 in a schematic front view with some parts removed in order to highlight others ;
• FIG. 6 illustrates a detail of the drum of figure 2 in a schematic side view with some parts removed in order to highlight others.
• FIG 1 the machine which is the subject of the present invention and which is generally indicated by the number 100, is used for the assembly of medical devices such as infusion catheters 1, for example the catheter illustrated in figure 4.
• Each infusion catheter 1 essentially consists of a plurality of components (refer to figure 1):
• first flexible tube 2a (which can have various diameters and lengths depending on its intended purpose) having a first end and a second end;
• first flow control valve 4 associated in a point of the first tube 2a
• second connecting valve 5 (of various types, shapes or geometries, depending on the intended purpose) connected to the second end of the first tube 2a;
• a second flexible tube 2b (which can have various diameters and lengths depending on its intended purpose) having a first end connected to the second valve 5 and a second end;
• a connector 6 (of various types, shapes or geometries, depending on the intended purpose) associated to the second end of the second tube 2b.
• the machine 100 comprises a drum 7 which rotates about a horizontal axis X7.
• the drum 7 has a cylindrical surface which is subdivided in a first section 7a, a second section 7b, and a third section 7c rotating in synchronised fashion with each other about the horizontal axis X7.
• Each first 7a, second 7b and third 7b section has a corresponding first 8a, second 8b and third 8c plurality of stations for the assembly of the components of the catheter 1, uniformly distributed along the cylindrical surface and along its entire extension.
• Each of the trios composed of a first 8a, a second 8b, and a third 8b assembly station defines a single assembly line, parallel to the horizontal axis X7 of rotation, in such a way as to configure a single assembly station for a single catheter 1.
• the machine 100 also comprises a plurality of operating stations 9a-9g positioned around the rotating drum 7 and in positions which are angularly different from each other, with reference to the horizontal axis X7 of rotation.
• Each station 9a-9g is configured to intercept a first 8a or a second 8b or a third 8c assembly station, according to a predetermined sequence and following at least a partial rotation of the drum 7, to position one of the components of the catheter 1 in a corresponding first 8a, second 8b, or third 8c station, or to connect to one another at least two components of the catheter 1 positioned in the corresponding first 8a, or second 8b, or third 8c station.
• the drum defines a plurality of assembly stations for corresponding catheters, along an arc of 360 degrees, each of which works in synchronous fashion with the operating stations located around the drum.
• the drum 7 rotates in a counterclockwise direction and preferably in a discontinuous motion to allow the individual stations to perform their steps.
• the machine 100 comprises a plurality of supply receptacles 10 for the corresponding components of the catheter 1 at corresponding operating stations 9a-9g or directly at a first 8a or second 8b or third 8c assembly station.
• the plurality of receptacles 10 are positioned each at different heights with regard to a load-bearing reference surface P (see figure 5 in particular).
• load-bearing surface P refers to the surface on which the support frame of the drum 7 rests.
• At least one of the first 7a, second 7b, and third 7c sections comprises first means 11 for movement of the corresponding first 8a or second 8b or third 8c assembly station configured for moving the first 8a, or second 8b, or third 8c station parallel to the horizontal axis X7, in both directions towards or away from an adjacent station of one of the other sections 7a or 7b or 7c.
• At least one of the first 7a, second 7b, and third 7c sections comprises second means 12 for movement of the corresponding first 8a or second 8b or third 8c assembly station configured for moving the first 8a, or second 8b, or third 8c station transversely to the horizontal axis X7, in both directions towards or away from the horizontal surface, in order to move towards or away from at least one of the operating stations 9a-9g.
• first 11 and second 12 means of movement are interconnected with each other on the first 7 a or second 7b or third 7c section (here, for illustrative purposes, it is the third section 7c) in order to allow for a combined movement along two axes - parallel and transversal to the horizontal axis X7 - of the first 8a or second 8b or third 8c station (here, for illustrative purposes, it is the third station 8c).
• each of the first 7a, second 7b and third 7c section of the drum 7 defines cylindrical portions that are independent from each other, with a corresponding cylindrical surface, and connected by means of a joint rotary support shaft 17.
• first section 7a is substantially a carousel connected to the rotary shaft 17 and provided with first stations 8a.
• the first section 7a or carousel, has two subsections 7a 1 , 7a2 on which the first assembly stations 8a are positioned, defining two corresponding substations Sa l , 8a2.
• the first subsection 7a 1 comprises a plurality of substations 8a 1 defining a stationary collecting device to collect a working quantity of flexible tube 2, intended to become (subsequently) the first 2a and the second 2b flexible tube.
• the substation 8a 1 is configured to collect the flexible tube 2 between a first stretch of flexible tube 2 and a second stretch of flexible tube 2.
• the second subsection 7a2 comprises a plurality of subsections 8a2 having a device 13 for gripping and stationary positioning the first stretch of flexible tube 2 defining also the first end of the first flexible tube 2a of the drip chamber 3, when applied by a relative operating station 9a-9g to the first end of the flexible tube 2, and of the first flow control valve 4 when applied to the flexible tube 2 by a relative operating station 9.
• the flexible tube 2 can be supplied parallel to the axis X7 of rotation in such a manner as to be positioned along the three stations 8a, 8b, 8c, through a receptacle 10a having spools onto which the tube 2 is wound (figure 1).
• an apposite operating station 9a- 9g (illustrated here by a block, indicated by 9a) unwinds the tube 2 from the receptacle 10a until the length of flexible tube 2 is equal to the sum of the first 2a and the second 2b flexible tube to be used, and positions it, rolled up, on the substation 8a 1 of the first section 7a 1 .
• the first stretch of the unwound flexible tube 2 is held by the second substation 7a2, while the second stretch is positioned along the second 8b and third 8c stations for further operations and assembly (as will be described in more detail below).
• the substation 8a2 of the second subsection 7a2 arrives at several operating stations 9a-9g (indicated here by 9b and 9c) which supply and connect, on the first stretch of flexible tube 2, the drip chamber 3 to the end of the flexible tube 2 and the first flow control valve 4 along the first stretch of the tube 2.
• These two operating stations 9b and 9c are connected to corresponding receptacles 10b and 10c located overhead and supplying, respectively, the drip chamber 3 and the first flow control valve 4.
• the second section 7b (intermediate between the other two sections 7a, 7c) has a plurality of second stations 8b each having gripping members 14 to hold a part of the second stretch of the flexible tube 2.
• the third section 7c has a plurality of third stations 8c each comprising a slide 15 provided with a gripping device 16 to hold a part of the second stretch of flexible tube 2.
• Each slide 15 is at least movable in the two directions parallel to the horizontal axis X7 of rotation, at least between a first operational position near the corresponding second station 8b (figures 2 and 3 and the upper portion of 6) and a second operational position away from the corresponding second station 8b following the separation of the second stretch of flexible tube 2, performed by a relative operating station 9, in order to create the second flexible tube 2b, held by the slide 15, and the second end of the first flexible tube 2a, held by the second station 8b and onto which, subsequent to the separation from the second stretch of flexible tube 2, the second connecting valve 5 is applied by a relative operating station 9a-9g and following a rotation of the drum about the horizontal axis X7.
• the slide 15 is also transversely movable with regard to the horizontal axis X7 of rotation between a first operational position, which is raised with respect to the second station 8b, and a second operational position which is on the same plane as the second station 8b, in such a manner as to arrive, in sequence and following the corresponding rotations of the drum 7 about the horizontal axis X7 of rotation, at at least two operating stations 9a-9g for the application of the connector 6 to the second end of the flexible tube 2b and, respectively, of the second connecting valve 5 to the first end of the second flexible tube 2b.
• the slide 15 is connected to the above-mentioned first and second means 11, 12 of movement to allow the slide 15 to move in a parallel and in a transverse direction with respect to the axis X7 of rotation.
• the first means 11 of movement comprise a combination of an actuator 11a (illustrated as a block) and cylinders lib connected to the slide 15.
• the cylinders lib are arranged in parallel to the axis X7 and allow the slide to move in the two directions.
• the second means 12 of movement comprise a combination of an actuator 12a (illustrated as a block) and cylinders 12b connected to the slide 15.
• the cylinders 12b are arranged radially to the axis X7 and allow the slide to move upwards and downwards.
• a ring 18 posterior to the third section 7c a ring 18 is located which is fi ed with respect to the third section 7c.
• This ring 18 has an annular counter-surface 19 for the cylinders lib of the first means 11 of movement passing over, configured with a variable profile to allow for the stable backwards and forwards motion of the cylinders lib, as well as for their stability when raised overhead when the cylinders 12b raise the slide 15.
• each second and third station 8b and 8c could essentially be the following, during corresponding rotations of the drum 7: - separation of the second stretch of flexible tube 2 between the second station 8b and the slide 15, in order to create the second end of the first flexible tube 2a (on the second station 8b) and the second flexible tube 2b (on the slide 15) in a station 9d;
• the catheter 1 is released onto a conveyer belt 20.
• the structure of the stations, the operating stations and the architecture of the receptacles provide a high level of operational flexibility and a rapid switching of catheter types, i.e. the lengths and diameters of the flexible tubes that are to be assembled, the types of valves, etc..

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Biophysics (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Mechanical Engineering (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (2)

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Cited By (1)

Citations (6)

• 2017
  • 2017-10-30 IT IT102017000123080A patent/IT201700123080A1/it unknown
• 2018
  • 2018-10-10 WO PCT/EP2018/077581 patent/WO2019086220A1/en active Application Filing

Patent Citations (6)

Non-Patent Citations (2)

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