MXPA95001294A - Method to produce packing media for medical products as contact lenses in particular sua contact lenses - Google Patents

Abstract

The present invention relates to a method for producing a package for medical products such as contact lenses, in particular disposable contact lenses, with at least one support comprising a removable closure member for at least one medical product, for a fluid protector that moistens the medical product, each support being constructed as a plastic bottle, with the following stages of production: a) forming a bottle body with an integrally formed neck, from an extruded tube or by two regions therein, in a blow mold for each support, b) while the bottle body is still placed in the mold by blowing, the protective fluid and the medical product are introduced in the latter, c) then the closure member is integrally formed in the neck and thus Support is hermetically sealed

Description

PACKAGING FOR MEDICINAL PRODUCTS Description Field of the Invention The present invention relates to a packaging for contact lenses, particularly for disposable contact lenses, in the form of a plastic bottle having a peelable cap. Background of the Invention A conventional package for contact lenses is the packaging based on ampules or "blisters". An excessively flat sheet of plastic has a plurality of deformations that generally have a semi-spherical shape on one side. Each of these deformations stores a contact lens. To protect contact lenses against drying such a receptacle formed by a deformation is also filled with some protective liquid. On the opposite side of the receptacles a metal film is connected to the flat portions of the sheet so that all the receptacles will be firmly sealed. Summary of the Invention An object of the present invention is to provide an improved package for medicinal products, such as contact lenses and particularly disposable contact lenses.

This object is achieved according to the present invention by a package comprising a first receptacle, configured as a plastic bottle for receiving a contact lens and a protective liquid for cleaning the contact lens, as well as a detachable plug attached to the bottle. Another object of the present invention involves providing an improved method for packaging medical products, such as contact lenses and in particular disposable contact lenses. The above object is achieved according to the present invention through a method of producing a package for medicinal products comprising the steps of forming a receptacle with a bottle body and a neck configured from an extruded tube in an apparatus of blow molding while the body of the bottle is still located in the blow molding apparatus, inserting a protective liquid and a medicinal product into the receptacle and after inserting the protective liquid and the medicinal product into the receptacle, forming a stopper that will be sealed firmly on the neck, from the extruded tube. As it is an autonomous unit and by eliminating the use of glues and bonding materials, the packaging according to the present invention guarantees a high level of safety against microbial and chemical contamination. The packaging is especially useful for disposable contact lenses. However, the package can also be used for other medicinal products. Since each receptacle is configured as a bottle, the package is especially easy to manipulate when opened. As for the packaging of ampoules or blisters developed to carry solid parts, a bottle constructed to receive and contain liquids offers the advantage that during the opening of the package no protective liquid is spilled. The bottle is filled and sealed in the conventional manner for ampoules. Thus, the manufacturing cost can be kept very low. The inner cross section of the neck portion, in all directions, exceeds the cross section of a contact lens or any other medicinal product stored therein. This arrangement prevents the contact lens from locking on the neck of the package during its introduction and removal, in any orientation. As a result of the special construction of the separation or break line in an annular zone with decreased thickness of the wall, advantageously in the basic form of a constriction, it is easy to open the bottle. The plug can advantageously be constructed in such a way that even after the receptacle is opened, it can be resealed firmly. Thus, the protective liquid can be safely stored until it is disposed of as a waste material, or a receptacle can contain more than a single contact lens. With the construction of manual contact areas in the plug, detachment or rupture of the plug from the rest of the receptacle is facilitated. In a preferred embodiment, a holding device holds the medicinal product, such as a contact lens, inside a receptacle so that when the cap is removed the medicinal product can be easily removed from the receptacle. Advantageously, the retaining device can be configured as an insert that can be removed from the receptacle. Then you can take a contact lens without any difficulty. It is possible to build a single piece. In a construction in which the receptacle and the retainer are separated from the plug, all parts are easier to manufacture than in a one-piece construction.

By constructing a thread integrated into a part of the receptacle the retainer device can be guided and secured in a defined position within the receptacle before and during breakage of the cap, and this device will be guided during its removal. When the retainer device together with the cap is detachable from the receptacle, the opening process is simplified. If the contact lens is a soft contact lens, the retaining device can advantageously be advantageously configured as a clamping device. The soft contact lens can be retained securely in the embracing device either in its rolled or folded condition and can be easily removed. Advantageous is the one-piece shape of the package with a plurality of receptacles, for example, in the form of a block of ampoules in which a number of supports are located one after the other. With break points located between the individual receptacles, receptacles can be separated therebetween. The handling during the removal of the contact lens is facilitated considerably. The method for producing the package according to the present invention has the advantage that bottle bodies and stoppers can be produced at low cost, especially in terms of a simultaneous production of a plurality of receptacles or bottle bodies. With the filling of the protective liquid and the contact lenses and also with the closure while the bottle bodies are still in the blow mold, sterility and low protection costs can be achieved, all without any problem. Other objects, advantages and salient features of the present invention will be apparent from the following detailed description, which, taken in conjunction with the accompanying drawings, represents preferred embodiments of the present invention. Brief Description of the Drawings With reference to the drawings forming a part of this text: Figure 1 is a side elevational view of a package according to a first embodiment of the present invention. Figure 2 is a side elevational view of the package of Figure 1 with the cap inserted into the neck and sealed after the other end of the cap has been peeled off. Figure 3 is a top view on the package of Figure 1.

Figure 4 is a side elevational view of a package according to the second embodiment of the present invention, partially in section through the area of the line of rupture. Figure 5 is a top view of the package according to Figure 4. Figure 6 is a side elevational view, partly in section, of a package according to a third embodiment of the present invention. Figure 7 is a side view, partly in section, of a package according to a fourth embodiment of the present invention. Figure 8 is a top view in section taken along line VIII-VIII of Figure 7 of the lens holder carrying a soft lens in folded condition. Figure 9 is a partially sectioned side view of a package according to a fifth embodiment of the present invention, and Figure 10 is a top view on the package according to Figure 9. Detailed Description of the Invention The first embodiment of the package according to the present invention has a receptacle in the form of a vial for a contact lens and a protective liquid. This receptacle can be resealed after opening. The receptacle 1 is shown in Figure 1, roughly in full scale. It is made of plastic. The receptacle 1 has an axially symmetrical bottle body 1 'connected to an axially symmetrical neck 3. The end of the bottle body 1', opposite the neck 3, is closed with a concave or convex bottom to the inside. In the connection to the bottle body 1 ', the neck 3 has three segments one after the other. The inner diameter of each segment is smaller than that of the body of the bottle 1 '. A first cylindrical ring is joined to another ring with a similar cylindrical shape but having a larger diameter. The second ring is joined to a segment that tapers conically until it reaches a detachment or break line 5. The break line 5 has the same diameter as the first ring of the neck 3. A plug 7 is attached to the neck 3 through the break line 5. The main, cylindrical, prolonged part of the plug 7 has its outer diameter identical to that of the second ring of the neck 3. The end of the plug 7, adjacent to the neck 3, has a tapered area that tapers conically towards the line of rupture 5. The zone g of ahusamiéhto connects the plugóh to the neck 3 and the line of totuta 5 * Then the line of Jrotuira 5 is formed by the ba'e of a constriction area. The thickness of the breakage line 5, in relation to all other airs, is reduced so much that the plug 7 can be relatively easily separated from the neck 3 with a relatively light force by means of a rotation or rotation of the head. stopper relative to the bottle body l1. Two contact depressions 9, one in opposition to the other, are formed on the outer covering face of the main part of the plug 7. At the end of the plug 7, opposite the breaking line 5, there is provided a shutter 11 with a cylindrical part. The outer diameter of the cylindrical part corresponds to the inner diameter of the neck 3, especially in the breaking line 5 and in the area of the first ring of the neck 3. The free end of the shutter 11 is formed by a hemisphere. If the receptacle 1, which is illustrated in the closed state in Figure 1, is open, the plug 7 can be rotated and its end having the plug 11 can be inserted into the neck 3, as shown in Figure 2. It is then tightly seals receptacle 1 due to the tight fit dimensions of shutter 11 and the inside diameter of neck 3.

Upon completion of the fabrication, the receptacle 1 contains a contact lens and a protective liquid to keep the contact lens clean and sterile within the bottle body 1 '. The interior cross-sectional dimensions of the neck 3 are selected to be superior to the transverse dimensions of the contact lens in all directions. Thus, the contact lens can be removed through the neck 3 without a jam. To obtain the contact lens when required, the receptacle 1 is opened by breaking the unit in the detachment or breakage line 5. If receptacle 1 contains more than a single contact lens or if no contact element is available. waste of the protective liquid during the opening of the receptacle 1, the latter can be firmly resealed by introducing the obturator 11 into the neck 3. In the second exemplary embodiment of Figures 4 and 5 the receptacle 101 is similarly constructed as a plastic bottle in the shape and size of a vial, which contains a contact lens and a protective liquid for the contact lens. The receptacle 101 has a bottle body 101 ', as in the first embodiment, which remains axially symmetrical and which is constructed with a concave or convex bottom to the interior. At the end of the bottle body 101 »opposite the bottom a cylindrical annular neck 103 is attached to the bottle body. A disc-shaped part or annular plate projects radially from the outer cover face of the neck 103 and has internal and external demarcations. The inner demarcation is connected to the neck 103 while the outer demarcation is attached to a plug 107. This section has a decreased thickness of the wall compared to the other parts of the receptacle 101, so that it forms a detachment line or break 105 between the neck 103 and the plug 107. The plug 107 has a cylindrical area, axially parallel to the neck 103. One end of the plug is attached to the part of material forming the line of rupture 105. The other end of this cylindrical area is sealed with a curved covering and carries a contact point or member take 109. The contact member 109 has a rectangular configuration and is attached on one narrow side to the other part of the plug 107. Along the other three sides, the contact point 109 has a lath. This strip has a circular configuration in cross section, perpendicular to the plane of the contact point 109. By rotating or overturning the contact element 109 in relation to the bottle body 101 ', it breaks in the line of break 105. Then it is disconnect the plug 107 from the neck 103 and the contact lens can be removed.

When the contact lens is packaged to float highly in the receptacle, difficulties may arise during its removal. The user's finger may get wet and become sticky during the extraction as it has come into contact with the protective liquid. These problems can be avoided by the use of a retainer device for the contact lens. The third embodiment of the package, illustrated in Figure 6, shows a package with a retainer 213 for at least one medicinal product, such as a contact lens, and especially a disposable contact lens. The container 201 comprises a neck 203 with a rupture cap 207 as configured in the second embodiment. The retainer 213 is arranged or mounted to the interior of the container 201. A support cap 217 of the retainer 213 is partially arranged in the area of the neck 203 and partly enclosed by the cap 207. A bar-type lens holder 215 can be mounted on the support cover 217. The support 215 and the cover 217 form the retaining device 213 projecting into the bottle part of the container 201. The retaining device 213 is constructed as an insert. When the plug 207 is broken, the retainer 213 can be removed from the container 201. The support lid 217 is formed in a piece that consists of three parts. A first cylindrical part of the support lid 217 is attached to the lens holder 215. A lid 217 has a smaller diameter than the neck 203. When the container 201 is closed, the first cylindrical part is arranged within the neck 203. A second cylindrical part of the support cap 217 has a diameter that is greater than the inside diameter of the neck 203 and is attached to the first cylindrical portion of the support cap 217 on its side opposite the lens holder. The second cylindrical part of the support cap 217 is arranged within the cap 207. The two cylindrical portions of the support cap 217 have concentric axes and are positioned with the front faces facing each other. These axes are also concentric with the axis of the lens holder 215 configured at least partially as a rod. On the front face opposite the first cylindrical part, the second cylindrical part of the support lid 213 has a tap member that is located inside the plug 207. The lens holder 215 is configured at its end opposite the support lid 217 for holding firmly a hard lens inserted in the lens holder 215. In the production of the packing arrangement according to the present invention, the retaining device is formed separately from the container 201 and the cap 207 and is formed before them. After the construction of the neck 203 and after filling of the protective liquid with all the lenses, the retaining device is inserted up to a certain distance in the container 201 until the second cylindrical part of the support lid 217 comes into contact with the end of the neck 203. Finally the cap 207 is formed. This keeps the support cap 217 in position on the end of the neck as long as the neck is pressed against the free end of the pick-up device. After the break of the plug 207, the retainer 213 can be removed from the container 201. Due to the separate construction of the plug 207 and the retainer 213, the tools and the steps of conventional methods for the production of ampoules are still used. With the use of soft lenses, instead of hard lenses, the contact lens could be inverted during the removal of conventional contact lens containers. The production this problem is prevented by fixing the soft lens. The fourth embodiment of the package, which is illustrated in Figures 7 and 8, shows a detachable retainer device in conjunction with the plug. The retainer device is configured as a clamping device for a soft lens, folded, or folded on itself. The container 301 is configured up to the plug 307 in the same manner as in the second and third embodiment. The support cover 317 of the retaining device 313 has, as in the third embodiment, a part that communicates with the neck, however, it is configured conically in the fourth embodiment. A cylindrical part, with a diameter whose size is greater than the inner diameter of the neck, is supported by the support lid 317, present at the end of the neck. Instead of having the socket arrangement constructed on the support cover 317, the cover of the fourth embodiment has a disc or a plate, arranged concentrically with respect to the other parts of the support cover 317 and which is configured with perfect adjustment as to its shape on the side of the support cap 317 opposite the part entering the neck. The diameter of the disk of the plate is greater than the diameter of the other parts of the support cover 317. The plate is inserted in an annular recess present on the inner side of the cap 307. Thus the retaining device 313 is fixed in relation to the stopper 307. The production and insertion of the retainer device takes place through the same method as in the third embodiment. However, the plug 307 is formed in such a way that it passes firmly around the support cover 317. The lens holder 315 of the retaining device 313 is configured as a clamping device. Two symmetrical, tongue-like parts, each with the cross-sectional shape of a circular segment, leave an intermediate space free. A bent soft lens is inserted into the interspace and secured in the package during the production of this package. After detachment or rupture of the cap 307, the soft lens can be removed from the retainer 313 while the user's fingers remain dry. The soft lens unfolds or unfolds automatically and rests on the finger in the manner required for its use. After opening the package it can advantageously be resealed. Resealing is particularly important when packing more than a single contact lens or when the protective liquid needs to be changed or disposed of as waste material. The fifth embodiment of the package illustrated in Figures 9 and 10, for medicinal products such as contact lenses, especially disposable contact lenses, has a retainer device with a screw system. The thread communicates even inside the threaded envelope of the container.

A container 401 has a bottle body for the protective liquid and a neck 403 configured as in the other embodiments. A threaded casing 419, which has an internal thread, is constructed within the neck 403 but preferably is not configured in one piece with the neck. The neck 403 and the threaded casing 419 intercommunicate by means of an undulating structure present on the relevant sides facing each other. The threaded casing 419 is immobile with respect to the longitudinal axis of the container 401 so that the threaded casing 419 forms a part of the container 401. As in the embodiments, from the first to the fourth inclusive, a removable cap 407 is attached to the neck 403 by means of a tear line 405. The plug 407 has wing or lobe type pickup members 409 arranged diametrically in interposition on each side of the container shaft 401. The support cap 417 of the retainer 413 is provided with a thread external 417 'in a portion thereof that is received in the neck 403. The external thread 417' communicates with the internal thread of the threaded wrapper 419 and fits securely therein. By the contact between neck 403 and threaded casing 419, by contacting the threaded casing 419 and the support cap 417 and due to the mounting of a shoulder or support cap 417 on a shoulder of the threaded casing 419, they are firmly interconnected as the threaded casing 419 and the support lid. Thus, when the plug 407 is broken, the container 401 is sealed firmly. As part of a retainer device, the lens holder 415 has a hole at its end facing downwardly from the support lid 417. The lens holder 415 can receive a lens soft rolled Otherwise the lens holder 415 has the same construction as the lens holder of the fourth embodiment, however it is configured with a larger internal dimension. For the opening of the container 401, before and during the rupture or the detachment of the plug 407, the retainer 413 is secured in a defined position within the container 401. After detachment of the plug 407, the retainer 413 must be detached by unscrewing or it must be unscrewed from the threaded casing 419. The threaded casing 419 guides the holding device 413 to be able to remove the contact lens from the lens holder 415. After removing the contact lens, with the help of the thread between the retaining device 413 and the casing threaded 419, the container 401 may be resealed by reattaching the retainer 413 in the threaded wrapper 419.

During production, the retaining device and the threaded casing can be advantageously prefabricated and interconnected by screwing and the lens holder can be provided with a contact lens before this set of insert parts is put in place in the neck, after the construction of the bottle body and filling of the protective liquid in the neck partially built and integrated. After the threaded wrap assembly and retaining device is inserted into the neck, the undulating structure of the neck can be formed by tightening the neck radially inwardly on the threaded wrapper. This production system has been disclosed in the North American Patent Number 4,425,090 in the name of Hansen, whose material is incorporated in this text as a reference material. The lens holder for hard lenses and for soft lenses folded or rolled up which is described in the third, fourth and fifth embodiment could be combined with any of the support caps described in these embodiments to obtain different modalities. In addition, the shapes and dimensions of the bottle and plug of the different embodiments can be combined with the different retainer devices. For larger packaging units, a packing arrangement of a plurality of containers can be advantageously provided. In such a packaging arrangement, the containers are advantageously parallel and they will be arranged with a small spacing between them to form a block. To stabilize such a block during handling, for example, for an even larger number of units, hollow bodies could be formed from the edge areas of the scrap, as shown for example in the North American Patent Application Number. Series 07 / 637,971, entitled "Procedure to Produce Hollow Plastic Receptacles", which was presented on January 9, 1991 in the name of Bernd Hansen, whose subject is included in this text as a reference material. The lines of breakage or detachment can be advantageously formed between the individual containers and can be arranged in the area of the edges of the scrap. After removal of the first contact lens from a container, the empty container can be broken and the package arrangement can be brought to the dimensions corresponding to the number of contact lenses still stored therein. Then the packing arrangement assumes the most manageable and convenient way. For the method of producing the package or the packaging arrangement, the tool preferably has four parts. An extruded tube of plastic material is inserted between two lower halves of the tool.

Through the pressure inside the tube and / or the vacuum pressure present outside, a bottle body is formed for each container, with a bottom and a shaped neck. In the packaging arrangements with hollow bodies in the areas of the edges of the scrap, these hollow bodies are preferably formed simultaneously with the bodies of the bottles. In the next step of the method, with the body of the bottle still located in the blow mold, the protective liquid, as well as the contact lens or other medicinal product is introduced into the container. In the embodiments with retainer devices, these devices are prefabricated, preferably in a complete form of plastic material, equipped with a similar contact lens and after the introduction of the protective liquid are mounted in any container. In the last step of the method, both upper halves of the tool are guided to the packaging arrangement and thus the plug or the plugs on the neck or collars can be formed. This will keep the containers firmly sealed and the tool can then release the finished packaging arrangement. While various embodiments have been selected to illustrate the invention, those skilled in the art will understand that it is possible to introduce various changes and modifications without departing from the scope of the invention as defined in the appended claims.

Claims (15)

1. NOVELTY OF THE INVENTION Having described the foregoing invention, the content of the following CLAIMSI is claimed as property 1. A package for medicinal products comprising: a first container configured as a plastic bottle for receiving a contact lens and a protective liquid which serves to clean the contact lens, and a removable cap attached to the bottle. A package according to claim 1, wherein the container comprises a bottle body with a neck, said neck having internal cross-sectional dimensions greater than the dimensions of the medicinal product in all directions, and in which the cap is coupled to the neck by a break line. 3. A package according to claim 2, wherein the breaking line comprises an annular zone with a reduced wall thickness. 4. A package according to claim 3, wherein the annular zone comprises a construction formed in the container. 5. A package according to claim 1, wherein the container is configured as a vial. A package according to claim 2, wherein the plug comprises a plug formed at one end of the plug opposite the line of rupture, the plug being received within the neck to seal the closed neck. A package according to claim 6, in which the plug comprises a cylindrical outer cover face of relatively large dimensions in a position adjacent to the break line and two intake depressions, arranged in the opposite position. A package according to claim 2, wherein the plug comprises a pick-up element extending essentially in a radial plane on an end thereof opposite to the line of tear. A package according to claim 2, wherein the container comprises a retainer device inserted therein and extractable therefrom to retain a contact lens. A package according to claim 9, wherein the retainer device is formed separately from the plug. A package according to claim 9, wherein the retainer devices comprise a threaded portion that comes into screw contact with an associated part of the container. 12. A package according to claim 9, wherein the cap is coupled to the retainer device for simultaneous removal of the container. 13. A package according to claim 9, wherein the retaining device comprises a clamping element for a bent soft contact lens. A package according to claim 1, in which a second container configured similarly to the first container is coupled to the first container and is located adjacent thereto, and a line of rupture extending between the first and the second container to separate the the containers. 15. A method for producing a package for medicinal products comprising the steps of: forming a container with a bottle body and a neck formed from an extruded tube in a blow molding apparatus while the body of The bottle is still placed in the blow molding apparatus, inserting a protective liquid and a medicinal product into the container, and after inserting the protective liquid and the medicinal product into the container, forming a stopper so that it is sealed firmly on the container. neck from the extruded tube.