Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
  • B29C64/10—Processes of additive manufacturing
  • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/753—Medical equipment; Accessories therefor
  • B29L2031/7532—Artificial members, protheses
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/753—Medical equipment; Accessories therefor
  • B29L2031/7546—Surgical equipment

Definitions

• the present invention relates to a device for the manufacture of an object by depositing layers, including successive layers of materials forming, in the object, a laminated structure.
• Such devices are well known, and are described for example in US 5,136,515 and US 2003/209836. They include: - a frame bearing:
• Compacting means for compacting and solidifying the material thus deposited, and a control member for controlling the table and the dispenser in order to move the table and the dispenser relative to one another and to order the deposit of matter on the table.
• Implants allow in particular the production of bone implants in biocompatible materials, by deposition of successive layers.
• the manufacture of these implants must be done with multiple precautions, so as to avoid that they are a source of infection. Implants must therefore be manufactured in a sterile setting, with materials that are perfectly clean in the medical sense of the term. They must be packaged and transported in conditions that allow perfect traceability. Taking all these precautions is very expensive.
• US 4,976,582 also discloses an object manufacturing device by depositing layers and whose tray can, in addition, be equipped with a flexible membrane closing a sterile enclosure.
• the nozzle of the dispenser must first enter the said chamber, by piercing thereof.
• Such a device makes it possible to reduce the risks of infection of the implant manufactured, but by the principle of deposition by successive layers, the initially sterile enclosure must be pierced with a large number of holes, making it particularly difficult to maintain the conditions of sufficient sterility.
• the enclosure is pierced with many holes, it becomes particularly difficult or impossible to act on the environmental conditions of the enclosure. It will for example be impossible to maintain a significant overpressure in the enclosure, during or after the manufacture of the object.
• An object of the present invention is to allow the manufacture of implants whose sterility is sufficient to be implanted safely while reducing manufacturing costs.
• the frame is further provided with an enclosure inside which are arranged at least the plate and the end of the nozzle, and outside this enclosure are arranged at least the movement control means of the table and the dispenser and the control member.
• the implant can be manufactured directly in the operating room in which the implant is to be put in place, or in a production environment that meets the standards necessary for the manufacture of medical implants such as GMP (Good Manufacturing
• the compacting means are of the electromagnetic radiation type and working in a wavelength corresponding to the blue color. It is possible to provide a device occupying a minimum volume, while having very high working speeds because the guide means of the table are parallel type, for example as described in the US Patent 4 '976'582.
• the dispenser comprises several containers and several nozzles, at least one nozzle per container.
• Optimal conditions of manufacture of the object can be obtained with a piezoelectric type extrusion member. This makes it possible to dispense the material at a high speed and a very precise dosage. This technology allows the synchronization of the displacement of the table and the dosage of the deposited material, which guarantees an optimal homogeneity of the deposited pattern.
• the present invention also relates to the use of the device inside an operating room as a means of manufacturing implants in situ. Brief description of the drawings
• FIG. 1 and 2 show the device according to the invention respectively seen from the side and from the front;
• FIG. 3 shows in perspective a part of the table and the dispenser which is equipped with the device;
• FIG. 4 is a sectional view of a tray carrying the dispensers;
• FIG. 5 is a sectional view along a plane perpendicular to the Z axis of the drive means of the table;
• FIG. 6 and 7 respectively show an overview and a detailed view of another embodiment of the device;
• FIGS. 1 and 2 shows a means of opening the device, to allow the extraction of an implant after manufacture
• FIGS. 9 to 12 illustrate the steps for constructing an implant by means of the device according to the invention
• Figure 13 schematically illustrates an operating room portion according to the invention.
• the device represented in FIGS. 1 and 2 comprises a frame 10 provided with partitions and doors which define four housings 12, 14, 16 and 18, inside which a dispenser 20 is arranged. , a mobile table 22 and compacting means 23, which will be described more precisely hereinafter, as well as a positron sensor 24 and a control member 25.
• the walls forming the central housing 12 are fixed on the frame 10, in a manner well known to those skilled in the art, to form a sufficiently sealed enclosure to ensure cleanliness, and thus prevent physical elements (eg dusts or textile fibers), biological (for example bacteria, viruses or any other type of microorganism) or chemical (molecules in gaseous, solid or liquid form) do not penetrate inside the housing 12, an essential condition for to guarantee a sterile environment necessary for the manufacture of medical implants.
• the upper wall of the housing 12, which also forms the bottom of the housing 14 comprises a fixed partition 26 pierced with a circular hole in which is mounted a tray 28.
• a ball bearing 30 and a seal 32 are interposed between the partition 26 and the plate 28. They respectively allow to guarantee accurate pivoting and to ensure tightness between the housings 12 and 14.
• the plate 28 carries, in addition, on the side of the housing 14, a toothed gear 34 at low pitch to allow its drive.
• the partition 26 carries a motor assembly 36 equipped with an indexing system, which makes it possible to determine the angular position of the plate
• the plate 28 carries, in addition, the dispenser 20, which comprises six containers 40a to 40f each containing one of the materials to be dispensed, six nozzles 42a to 42f, each connected to one of the containers, and six bodies extrusion 44a to 44f, each ensuring the extrusion of the material contained in one of the containers 40a to 40f and the out in the housing 12 through the nozzles, as will be explained later. Note that some of the containers and extrusion members are not visible in the figures. The containers 40 and the extrusion members 44 are in the housing 14 while the free end of the nozzles 42 is in the housing 12.
• each of the six nozzles 42 could be mounted on the tray 28 by means of a micrometric screw holder, for adjusting its position along the vertical axis Z, the actuation of the micrometer screw can be manual or motorized.
• the actuation of the micrometer screw can be manual or motorized.
• the extrusion members 44a to 44f are of the piezoelectric type, thus ensuring a very precise dosage of the material extracted from them. respective container and optimal conditions of deposit, as will be explained later.
• the bottom wall of the housing 12 is formed of a plate 46 on which is mounted the table 22.
• the latter has a parallel type structure, as defined in US Patent 4'976'582. It comprises housings 47 sealingly attached to the plate 46, open towards the housing 16 and inside which are arranged motors 48 whose rotor can rotate in both directions, gear reduction gear and indexing means.
• the motors 48 form the displacement control means of the table 22.
• the motors 48 used may be EC technology (Electronic Switching), DC (Direct Current) or step-by-step, that the skilled person can easily implement.
• the reduction gears are, according to known techniques, gearless gearboxes, of the drive or planetary harmony type, and the indexing means can be Sin / Cos or TTL type encoders.
• the shafts 49 trees, through the housing wall 47 and open into the housing 12. These shafts 49 are connected to their respective motor through the gear reduction gear.
• the shafts 49 are each connected to an articulated arm 50 of the structure of the table 22.
• the arms 50 form the guide means of the table 22.
• the ends of the arms 50 are hingedly connected to a plate 52 ( Figures 1 to 3).
• the latter is intended to receive the object to be created, as will be explained later. It can be round in shape, with a diameter of about 20 to 50 mm or more depending on the part to be manufactured.
• the plate 52 can also advantageously be assembled to the articulated arms 50 in a clip-on manner, according to known techniques, in order to facilitate its installation and removal from the device.
• the shafts 49 are mounted on ball bearings 53 arranged in the housings 47.
• a seal 54 is interposed between the shaft 49 and the wall of the housing 47, so as to ensure the cleanliness of the housing 12.
• the compaction means 23 are formed of a blue light source , of a wavelength typically between 450 nm and 500 nm, mounted on one of the side walls of the housing 12. It may be formed, for example, of a laser as sold by Blue Sky Research 1537 Center Drive Drive Milpitas, CA 95035, emitting in the blue.
• the position sensor 24 is of the optical type. It is attached to the side walls of the housing 12.
• nozzles 42 aims to accurately determine the position of the end of the nozzles 42 along the vertical axis Z in their working position, this position being the most difficult to control in the device as described above. It is possible to correct a positioning defect of one or the other nozzle 42 by moving the nozzle by means of a micrometer screw as explained above, or by slightly modifying the position of the plate 52. 25 is arranged in the housing 18. It is formed of a computer connected by suitable means, for example wires, to the motors and to the indexing means of the table 22, to the extrusion members 44, to the means compaction 23 and the position sensor 24. It is provided with a screen and a keyboard, which allow the programming and control of all.
• the control member 25 could also be arranged outside the frame, and connected to the other organs of the device over the air for example.
• the housing 12 further comprises a tray 55 for purging the sets that form the containers 40, the nozzles 42 and the extrusion members 44 ( Figure 1).
• the device further comprises means for acting on the environmental parameters of the housing 12.
• the modifiable environmental parameters are as follows:
• orifices are formed in the frame 10 or in the tank 101.
• the structure of the bottom of the housing 12 is, in this variant, consisting of a single piece, a tank 101 for receiving the movable table 22. Housing is machined in the tank 101, and for receiving the motors 48 and the shafts 49, allowing the driving of the articulated arms 50.
• the tank 101 conventionally produced by molding and machining methods, makes it possible to improve the tightness of the housing 12, by limiting the number of its openings.
• the shape of the tank 101 is also optimized so the high force generated by the pressure during the sterilization does not create mechanical deformation of the drive elements that can influence the accuracy of the machine.
• FIG. 6 also shows the reduction gears 103 and the indexing means 104.
• connection between the motor 48 and the shaft 49 is performed by means of a flexible coupling 102, for example available from RW Kuppl Institute, Germany.
• a flexible coupling 102 limits the heat exchange between the housing 12 on the one hand and the reduction gears 103, the motors 48 and the indexing means 104 on the other hand. in the tank 101 to allow, if the transmitted heat proved to be too great despite the presence of the flexible coupling 102, cooling the shafts 49 by injection of a cooling fluid, typically the pressurized air.
• a cooling fluid typically the pressurized air.
• the compacting means of the material dispensed by the nozzles 42 consists of a laser, a model identical or similar to that described above, but the particularity of which is advantageously located outside the housing 12.
• the laser beam product symbolized by the arrow 111, is then guided, by optical means known to those skilled in the art, inside the housing 12 into which it enters through the intermediate glazed surface not shown, covering a hole in the turntable 28.
• the window is assembled to the turntable 28 in a sealed manner, according to practices also known to those skilled in the art.
• the laser beam 111 enters the housing 12 through the center of the plate 28, so that the positioning of the ray 111 is not modified during the rotation of the plate 28, when for example, another nozzle 42 must be used . this allows to ensure that the laser beam 111 is always oriented so as to compact the material dispensed by the active nozzle 42 located above the plate 52.
• the housing 12 has no actuator or active sensor. As indicated above, this housing 12 can be subjected to very severe environmental constraints (mainly temperature and pressure during an autoclave sterilization). The present invention thus makes it possible to use equipment that supports so-called “commercial” or “industrial” environmental constraints while subjecting the housing 12 to much more severe environmental conditions.
• the present invention makes it possible to produce sterile implants while maintaining the necessary conditions inside the housing 12 before and during the manufacture of the implant. It will therefore generally after manufacture, handled by people equipped with at least gloves or by robotic arms, and it is therefore appropriate, once the implant manufactured, to facilitate its extraction by providing a sufficient opening of the housing 12.
• the housing 12 is delimited by the tank 101 and walls 205, the sealing being ensured, in the closed position, by a seal 204.
• the opening of the housing 12 is effected by translation of the tank 101 along the vertical axis Z.
• the tank 101 is mounted on the rails 201 performing a vertical guidance.
• An articulated arm 202 comprising two segments 202a and 202b, is fixed to the frame 10 and the tank 101.
• One end of the segment 202a is connected by a hinge to the frame 10.
• One end of the segment 202b is connected by a hinge to the tank 101.
• the other end of the segment 202a is connected by a hinge to the other end of the segment 202b.
• the arm 202 is manipulated by means of an actuator 203, the actuator 203 being, for example, a ball screw driven by an electric motor or any other type of linear motor.
• the actuator 203 conventionally controlled by the control member 25, allows the deployment or the folding of the arm 202, which has the effect of moving the tank 101 vertically, respectively upwards and downwards.
• Such an actuation principle is known to those skilled in the art as a "toggle press".
• the stroke of the tank 101 is of the order of 10 to 20 cm.
• the two segments 202a and 202b are advantageously aligned vertically.
• This configuration makes it possible, on the one hand, to subject the gasket 204 to substantial compression and thus to ensure a good seal of the housing 12, and on the other hand to oppose a high resistance to opening, an essential characteristic during application. an overpressure in the housing 12, for example autoclave sterilization.
• an overpressure in the housing 12, for example autoclave sterilization is advantageously aligned vertically.
• the device according to one of the variants just described allows for 3D objects in a clean room, or sterile, which can be placed directly in the room where the object is to be used, for example in an operating room, or in a GMP production environment, to manufacture medical implants.
• a clean room or sterile
• Such an operating room will be described in more detail with reference to FIG. 13.
• the procedures and measures to be taken are considerably simplified. It is thus possible to significantly reduce costs, while improving their quality, including reducing the risk of contamination of the patient.
• the constituent material of the matrix may, for example be a pasty mixture of calcium phosphate powder mixed with a binder such as PEG, PLA or PLLA, which is added a photoinitiator such as that marketed by CIBA (CH) under the name Irgacure® 680.
• CIBA CIBA
• This photoinitiator has the effect of causing polymerization of the binder when it is subjected to blue radiation whose wavelength is between 450 nm and 500 nm, typically 470.degree. nm.
• Other photo-initiators are conceivable, being able to work from UV to NR without the procedure being fundamentally modified.
• the choice of radiation in the blue color has the advantage of reducing the risk of partially destroying bioactive materials.
• the filling of the container is in a sterile medium or in a medium called GMP, by means of a material itself sterilized.
• the container is then placed in a package ensuring the sterility of the container and its contents. It will not be released until the introduction of the container in the device.
• the pores of the implant can be filled with bioactive or bio-inductive materials, promoting, for example the growth of bones or that of veins and arteries. These materials are in the form of a hydrogel containing proteins and / or enzymes and / or cells promoting the regeneration of organs, whether bones or veins. This material, which can also be polymerized, also contains photoinitiator. For more information on this subject, reference is made to US 2005/0065281.
• Bioactive materials can not be sterilized, because their active ingredients would then be destroyed. They are therefore set up in a so-called GMP medium, proper in the medical sense of the term, in previously sterilized containers. These are also put in a protective packaging that is removed at the last moment.
• the housing 12 and the nozzles 42 are sterilized.
• the nozzles are sterilized by means of a source of gas, chlorine dioxide or ethanol for example, introduced into the housing 14 and injected into the nozzles 42.
• the nozzles can also be sterilized by heating to +200.degree. or by injection of water vapor under pressure, by techniques known to those skilled in the art.
• the housing 12 is sterilized by one of the techniques mentioned above, by regulating and controlling its temperature, its hygrometry, its pressure, its gas composition and possibly its electromagnetic environment using the previously described means.
• the containers 40 are then put in place by an operator equipped sterile manner.
• the control member 25 then ensures the filling of the nozzles 42, by successively placing each of them above the tray 55, the extrusion members 44 controlling the injection of material into the nozzles 42 to what these are full.
• the control member then brings the nozzle 42a above the plate 52, while the latter is moved along the Z axis so that the distance between the nozzle and the plate is perfectly adjusted, the 0.20mm order, defined by those skilled in the art and programmed in the control member 25.
• This distance is typically between 0.10 to 0.30 mm, so that the deposit is made in continuous, that is to say without the drops generated by the extrusion members 44 have time to form.
• the distance between the nozzle 42 and the surface where the material must be deposited is verified by means of the position sensor 24. This latter verifies the position of the nozzle 42, that of the plate 52 being considered as accurate enough to serve as a reference.
• the nozzle 42a on the plate 52 As the pasty material is deposited by the nozzle 42a on the plate 52, it is made solid and compact by subjecting it to a blue radiation sent to the place where the material is deposited, by light emission of the compaction means 23. In this way, the deposited material is practically solidified instantaneously, preventing its spreading. It has a thickness typically between 0.10 mm and 0.30 mm, depending on the desired structure. As can be seen in FIG. 9, the material contained in the container 40a is deposited in the form of lines 56 leaving between them grooves intended to receive other materials, as will be explained hereinafter (FIG. 9). .
• the control member 25 rotates the turntable 28 to bring the nozzle 42b next to the plate 52.
• the control member 25 verifies the position of the end of the nozzle 42b by interrogating the position sensor 24 and corrects, if necessary the position of the plate 52 with reference to the end of the nozzle 42b.
• the controller 25 gives the orders generating the displacement of the plate 52 and the extrusion of the material contained in the container 40b to the nozzle 42b by the actuation of the extrusion member 44b. These operations are carried out simultaneously. Moreover, the compaction means 23 are also activated, polymerizing the deposited gel. This material is disposed in some of the spaces between the lines 56 that forms the first material, to form lines 58 ( Figure 10). When the material is deposited in all preprogrammed spaces, the control member 25 rotates the turntable 28 to bring the nozzle 42c opposite the plate 52 ( Figure 11). The control member 25 verifies the position of the end of the nozzle 42c by interrogating the position sensor 24 and corrects, if necessary the position of the plate 52 with reference to the end of the nozzle 42c.
• the controller 25 gives the orders generating the displacement of the plate 52 and the extrusion of the material of the container 40c to the nozzle 42c by the actuation of the extrusion member 44c. These operations are performed simultaneously. Moreover, the compaction means 23 are also activated, polymerizing the deposited gel. This material is disposed in some of the spaces between the lines 56 that forms the first material, to form lines 60, as can be seen in Figure 11.
• a first layer 62 thus formed lines 56, 58 and 60, is then formed.
• the constituent materials form a compact but heterogeneous mass.
• the control member 25 then prepares (FIG. 12) the device for depositing a second layer 64 superimposed on the layer 62 and comprising lines 66 whose orientation is different from that of the lines 56, 58 and 60, for example orthogonal. For this purpose, it places the nozzle 42d above the plate 52, according to the procedure previously described, and it moves the latter along the axis Z, so that the space between the nozzle 42d and the layer 62 corresponds to the optimal conditions of deposit.
• the device then deposits lines 66 made of the material contained in the container 4Od polymerized during its introduction.
• the container 40d may contain the same material or other than that contained in the container 40a.
• an implant formed of different biocompatible materials some of which are also bioactive.
• the shape of these implants can be defined by programming the control member. It can simply be a parallelepiped block, then cut by the surgeon, or a piece having a more complex shape allowing an implementation with a minimum of retouching.
• FIG 13 shows schematically an operating room.
• a table 68 on which a patient 70 is lying.
• a surgeon 72 and his or her instrumentalist 73 operate in the vicinity of the table 68. They have tools 74 arranged on a serving 76.
• An apparatus 78 as described above is placed under the service 76. [0065] In this configuration, when the implant is completed, manufactured directly in the sterile space of the operating room, the surgeon
• the implant 200 can be removed by controlling the actuator 203, in order to lower the bowl
• the quality of the implant can be guaranteed, while ensuring manufacturing conditions and management the simplest possible.
• the structure of the implant may also be different from that described with, for example, a structure in which the deposited lines are all oriented in the same direction.
• the number of nozzles and containers that must include the device can be variable. It depends on the number of materials constituting the implant and the volume of the latter.
• the means for controlling the environmental conditions of the housing 12 may also advantageously be used to adjust and maintain optimal conditions before, during or after the manufacture of the implant.
• a device as just described can also be used for purposes other than the manufacture of an implant. It could thus be used to manufacture objects by deposition of successive layers in a controlled atmosphere. In this case, it is essential that the enclosure formed by the housing 12 is connected to a source of the gas defining the controlled atmosphere. Depending on the gas used, it will also be necessary to provide means for extracting the enclosure in a controlled manner. It is also possible to form a film having only one layer, homogeneous or not. Such a film could also find applications in the medical field.
• the lines constituting the object to be manufactured may have orientations other than straight. It would be, without further possible to arrange them in circles or spiral, or even in a much more complex structure, to take into account the structure that must present the finished implant.
• the width of the lines may vary depending on where the deposit is made, by changing the orders given by the control member to the dispenser 22.

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• 2008
  • 2008-09-23 US US12/679,521 patent/US20100206224A1/en not_active Abandoned
  • 2008-09-23 EP EP08804621A patent/EP2203296A1/de not_active Withdrawn
  • 2008-09-23 WO PCT/EP2008/062707 patent/WO2009040352A1/fr active Application Filing

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