JP2003525782A - Modular bolster device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a modular bolster device which can be rapidly developed by being applied to an injection molding system for plastic parts constituting a dry powder inhaler or the like. A modular bolster device includes a tool block and a plurality of stackable cavity plates. The cavity plate 14 has an emission point and a runner 15 and an emission point 16. By combining the cavity plate 14, a cavity corresponding to the plastic component 17 to be manufactured is formed.

Description

Detailed Description of the Invention

The present invention relates to a new tool making method and a new process for using such tools.

Traditionally, the only option available to designers and technicians when designing plastic components is to make the desired plastic from prefabricated components made from bulk material procured in the form of sheets or bars. Was in getting the component. However, there are many problems with making plastic parts that make this method unsatisfactory. For example, not all materials are available as materials in sheet form, flexible hinges and springs are difficult to make identical, and small features are difficult to make. Therefore, off-the-shelf parts have typically only been used to form prototype prototypes. Thus, the designer could design and manufacture a preforming mold tool, and only then could complete the conceptual design and prototype. These prefabricated mold tools are
It is usually a reduced version of the final fabrication tool and can take up to 20 weeks to fabricate.

Recently, techniques such as stereolithography have emerged, enabling the production of a one-time disposable model that can be used as a “master” for a resin mold that enables the production of small volume parts. It was However, the number of materials that can be produced in this way is limited and this technique is only suitable for the development of prototype prototypes.

Traditionally, mold tools for fabrication are usually divided into three parts. (I) one or more cavities corresponding to the shape of the component to be made; (ii) a stationary half that includes the delivery or delivery system; and (iii) a moving half that includes the protrusion system.

The purpose of these molds is to make high volume, low cost components on automated injection molding machines. However, these tools are often complex and difficult to change if further optimization of the design is required.

With the ever-increasing need to reduce the time it takes to commercialize new products, it is important that a multi-functional approach be taken in the development of medical devices such as inhalers. This is a team of designers, engineers and scientists working together from the early stages of product development to ensure that the final inhaler design is suitable and available for use in critical medical trials. Means you have to do it.

Conventional tools have long lead times in fabrication, ie the time from start to finish, and due to the difficulty in changing these types of tools,
It is regarded as an obstacle to the rapid development of the device.

The development of new devices requires a versatile approach for designers, engineers, scientists and medical personnel. Prototype design and rapid engineering are the first important steps in this process. We use the appropriate materials for potential unique interactions, such as electrostatic interactions between certain pharmaceuticals / excipients and certain plastic materials, to make prototypes fast and economical. We have discovered a new tooling technique based on the manufacture of rigid tools consisting of plates or partial parts, which are made to be One further advantage of this technique is that the tools can be easily changed as the prototype of the device is refined.

[0009]   We have developed a new solution to the problems associated with rapid fabrication of hardenable tools.

Thus, in the present invention, we provide at least one pair of plates that may be stacked to form a cavity, the plate comprising a delivery and projection system, and a product. An injection molding system is provided that includes a cavity molding machine used to mold.

The injection molding system of the present invention is particularly suitable for the manufacture of small plastic devices such as medical devices such as inhalers. Inhaler devices produced by the system of the invention may be, for example, metered dose inhalers (MDI) and especially dry powder inhalers (DPI)
Any conventional known inhalation device such as can be configured. Examples of DPIs worth mentioning are the CLICKHALER® and TECHNOHALER® trademarks available from Innovata Biomed, UK. CLICKHALER is described in International Publication No. WO 92/00771, the specification of which is hereby incorporated by reference. TECHNOHALER is described in International Publication No. WO 93/16748, the specification of which is hereby incorporated by reference.

The cavity or cast molding apparatus used in the system of the present invention comprises an assembly of plates and segments. The plate is preferably a wire eroded plate.

In one further aspect of the invention, we provide a method of manufacturing a plastics device that includes injecting molten plastic material into an injection molding system, as described above.

We provide a plastic device manufactured by the method described above. The plastic device may be a medical device, such as an inhalation device, such as a DPI.

In one embodiment of the invention, the method of the invention comprises a body forming a storage chamber for storing a substance to be delivered, the body forming an inhalation passage through which air aspirated through the mouthpiece passes. And a metering member operable to transfer a volume dose of the substance from the storage chamber to the inhalation passage, the metering member being recessed to obtain at least one dispensing cup. Movable between a first position having a metering surface formed and the metering cup being sent to the suction passage, and a second position in which the metering cup is open upwards. And a metering member, the inhaler comprising cup content discharge means, the cup content discharge means including a dose of the substance in the dispense cup. Send to the road Any material that remains in the dispensing cup after being dispensed and before the dispensing cup is again sent to the storage chamber has a tendency to fall out of the dispensing cup under the effect of gravity. Included is means for moving each said dispensing cup into position.

In one further embodiment of the invention, the method of the invention comprises, for example, dispensing a plurality of desired volume doses of a flowable substance, a storage chamber for storing the substance, and a communication with the storage chamber. And a first and second element, each metering device capable of being intimately sealed to an inner wall of the outlet conduit to form an intermediate dosing space of a desired dose volume. And a substance surrounding each of the metering devices in the storage chamber, together with each of the metering devices, into the outlet conduit in the respective dosing space, Comprising the manufacture of a TECHNOHALER, such as a dispenser, characterized by means for advancing the dispenser sequentially from within the storage chamber into the outlet conduit.

The novel method of the present invention solves the manufacturing and lead time related difficulties in conventional mold tool making and eliminates the complex overhang and delivery system used in hardened tooling. The projecting and delivery system includes one common delivery system and is replaced by a modular bolster device with a cavity device assembled from wire erosion plates and segments.

In use, the cast molding device may be manually assembled and loaded into the modular bolster device while in the press. A material such as plastic can then be injected into the tool. Once cooled, the entire cast molding machine is manually removed. The plate may then be disassembled, the components removed, the cavities reassembled and the process repeated. By using wire erosion, plate-type tools can be quickly made within a day for simple parts, and even very complex shapes can take only a week.

The main advantage of this system is that parts can be molded with suitable fabrication materials, allowing designers to
It lies in the fact that molded parts can be changed very quickly, the finishing device can be quickly assembled and thus tested early. Furthermore, the prefabrication tool can be reliably manufactured. This is because the molded parts have already been tested and the time for tool development is reduced.

The method of the present invention is particularly suitable for manufacturing small plastic medical devices such as inhalation devices.

The advantages of the method of the invention are that injection-molded parts can be used to form complex models and that the device can be tested and refined without the need to make preform molds. The ability to perform early testing using the final material without material compatibility issues;
Significant cost savings and time savings over conventional methods.

[0022]   The present invention will now be described, by way of example only, with reference to the accompanying drawings.

In FIG. 1, a prior art injection molding system 1 comprises a moving half 2 and a stationary half 3. The stationary half 3 comprises an injection point and a runner 4 and a component cavity 5. The exercise half 2 comprises a protruding point 6. The moving half 2 comprises a female connector 7 located at each corner 8 which can engage a corresponding male connector 9 located at each corner 10 of the stationary half 3. A plastic component 11 is also shown.

In FIG. 2, the modular bolster device 12 comprises a tool block 13 and a plurality of stackable cavity plates 14 with injection points and runners 15 and injection points 16. A plastic component 17 is also shown.

Example 1 CLICKHALER The initial design was made in CAD to create three new component plate tools required by the new design. Minor changes from these parts were made with respect to the gear teeth and the location of the flexible ratchet fingers. Within a month, a new design working model was created that was suitable for laboratory testing to confirm the injection weight performance and dose consistency of the new inhaler design. The component design was then made in a fully cured cavity for use in a modular bolster system, which allowed the device to be made for medical testing. The entire program took about 3 months.

Example 2 TECHNOHALER The TECHNOHALER is a new inhaler currently being developed by Innovata Biomed that provides powder in multiple unit doses. TECHNO
HALER has a unique powder dispensing system that allows a series of spools to be pre-filled at the factory and then dispensed from the carousel in the machine.
This increases the accuracy of the dosing and protects the individual doses of powder from moisture. A prototype of the concept model was created using the plate molding technique described above. Now that a working prototype of the equipment mechanism and casing has been obtained, the engineering team
The design could be evaluated without the need to make expensive prefabricated mold tools.

[Brief description of drawings]

[Figure 1]   It is a perspective view which shows the molding tool in the injection molding system of a prior art.

[Fig. 2]   1 is a perspective view of a cavity injection molding (casting injection molding) system of the present invention.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), OA (BF , BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, G M, KE, LS, MW, MZ, SD, SL, SZ, TZ , UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, B Z, CA, CH, CN, CR, CU, CZ, DE, DK , DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, J P, KE, KG, KP, KR, KZ, LC, LK, LR , LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, R O, RU, SD, SE, SG, SI, SK, SL, TJ , TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW

Claims (10)

[Claims] 1. A modular bolster device comprising stackable plates that can be stacked to form a cavity to form a particular device. 2. The modular bolster device according to claim 1, which is used for manufacturing an inhaler. 3. The modular bolster device according to claim 2, wherein the inhaler is a dry powder inhaler. 4. The modular bolster device according to claim 3, wherein the inhaler is a CLICKHALER. 5. The modular bolster device of claim 3, wherein the inhaler is a TECHNOHALER. 6. A method of manufacturing a medical device, comprising manufacturing a medical device using the modular bolster device according to claim 1. 7. The medical device is an inhaler, the inhaler being a body having a storage chamber for storing a substance to be delivered and having an inhalation passage through which air inhaled through a mouthpiece passes. A body and a metering member operable to transfer a volume dose of the substance from the storage chamber to the inhalation passage, the metering member comprising:
A first position having a metering surface which is recessed to obtain at least one metering cup, the metering cup being fed to the suction passage, and the metering cup being directed upwards; A metering member movable between an open second position, the inhaler comprising a cup content ejecting means, the cup content ejecting means comprising a dose of the substance within the dispensing cup. Any substance remaining in the dispensing cup after it has been placed in the dispenser and delivered to the inhalation passage and before the dispenser cup is again delivered to the storage chamber is subjected to the weighing by the action of gravity. 7. A method as claimed in claim 6, characterized in that each of the dispensing cups is moved to a position which tends to fall out of the dispensing cup. 8. The medical device is a device for dispensing a plurality of desired volume doses of a flowable substance, the dispensing device comprising a storage chamber for storing the substance and an outlet communicating with the storage chamber. Conduits, the dispensing device comprising first and second end elements each of which may be tightly sealed to an inner wall of the outlet conduit so as to form an intermediate dosing space of the desired dosing volume with each dispensing device. A plurality of weighing devices having
Sequentially from within the storage chamber into the outlet conduit to cause the substance surrounding each metering device within the storage chamber to enter the outlet conduit within the respective dosing space with each metering device. 7. The method of claim 6, characterized by means for advancing the metering device. 9. A method of using the modular bolster device of claim 1 in the manufacture of a medical device. 10. A modular bolster device substantially the same as described with reference to the accompanying description and drawings.