US20020020500A1 - Method and system for manufacturing elastomeric articles - Google Patents
Method and system for manufacturing elastomeric articles Download PDFInfo
- Publication number
- US20020020500A1 US20020020500A1 US09/839,229 US83922901A US2002020500A1 US 20020020500 A1 US20020020500 A1 US 20020020500A1 US 83922901 A US83922901 A US 83922901A US 2002020500 A1 US2002020500 A1 US 2002020500A1
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- Prior art keywords
- rim
- elastomeric
- film
- carrier plate
- station
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- 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
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/10—Forming by pressure difference, e.g. vacuum
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- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
-
- 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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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- 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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
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- 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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/78—Means for handling the parts to be joined, e.g. for making containers or hollow articles, e.g. means for handling sheets, plates, web-like materials, tubular articles, hollow articles or elements to be joined therewith; Means for discharging the joined articles from the joining apparatus
- B29C65/7858—Means for handling the parts to be joined, e.g. for making containers or hollow articles, e.g. means for handling sheets, plates, web-like materials, tubular articles, hollow articles or elements to be joined therewith; Means for discharging the joined articles from the joining apparatus characterised by the feeding movement of the parts to be joined
- B29C65/7861—In-line machines, i.e. feeding, joining and discharging are in one production line
- B29C65/7867—In-line machines, i.e. feeding, joining and discharging are in one production line using carriers, provided with holding means, said carriers moving in a closed path
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/05—Particular design of joint configurations
- B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
- B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
- B29C66/112—Single lapped joints
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/05—Particular design of joint configurations
- B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
- B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
- B29C66/114—Single butt joints
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
- B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
- B29C66/832—Reciprocating joining or pressing tools
- B29C66/8322—Joining or pressing tools reciprocating along one axis
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/87—Auxiliary operations or devices
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91411—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91421—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the joining tools
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91441—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature the temperature being non-constant over time
- B29C66/91443—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature the temperature being non-constant over time following a temperature-time profile
- B29C66/91445—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature the temperature being non-constant over time following a temperature-time profile by steps
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
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- 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
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/04—Combined thermoforming and prestretching, e.g. biaxial stretching
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
- B29K2995/0037—Other properties
- B29K2995/007—Hardness
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- 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/12—Surface bonding means and/or assembly means with cutting, punching, piercing, severing or tearing
- Y10T156/1317—Means feeding plural workpieces to be joined
- Y10T156/1343—Cutting indefinite length web after assembly with discrete article
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/17—Surface bonding means and/or assemblymeans with work feeding or handling means
- Y10T156/1702—For plural parts or plural areas of single part
- Y10T156/1744—Means bringing discrete articles into assembled relationship
- Y10T156/1768—Means simultaneously conveying plural articles from a single source and serially presenting them to an assembly station
Definitions
- the present invention relates generally to a method and system for manufacturing elastomeric articles and more specifically to a method and system for manufacturing a device having a plurality of elastomeric portions, one of which is a relatively thin nonplanar portion and the other of which is a relatively thick portion, such as the devices of the types described in U.S. Pat. No. 5,295,984 for collecting vaginal discharge and/or vaginal delivery of substances such as medication, the entire disclosure of which is incorporated herein by reference.
- the system may be used, for example, to produce a particular product whose relatively thick portion may be an elastomeric rim and whose relatively thin portion may be a nonplanar thin elastomeric reservoir.
- devices of this type may be injection molded in one piece.
- injection molding is inappropriate because the reservoir component must be a very thin film.
- the reservoir may be vacuum-formed from a sheet of elastomeric material.
- a common method of producing a device whose reservoir is a very thin film is simply to attach a pre-formed reservoir to a separately formed rim.
- the pre-formed reservoir is difficult to manage because the very thin elastomeric film is fragile, sticks to itself and fails to retain its shape after it has been vacuum-formed.
- a plurality of first elastomeric portions is heat sealed to a second elastomeric portion having a planar form to create intermediate components that are subsequently placed in a vacuum mold in which the planar second elastomeric portion is formed to create a nonplanar thin portion.
- a sheet of elastomeric film is heat sealed to a batch of elastomeric rims to create drumheads that are subsequently placed in a vacuum mold in which the film portion is vacuum formed from the drumheads to form reservoirs.
- FIG. 1 is a plan view of a preferred embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 2 is an elevation view of a second preferred embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 3 is a perspective view of part of a carrier plate used in the system of FIG. 1.
- FIG. 4 is a cross-sectional view taken along section line IV-IV of FIG. 3.
- FIG. 5 is a perspective view of the load station of the system of FIG. 1.
- FIG. 6 is a perspective view of the heat seal station of the system of FIG. 1.
- FIG. 7 is a blown-up perspective view of the heat seal station of FIG. 4.
- FIG. 8 is a cross-sectional view taken along section line VIII-VIII of FIG. 7.
- FIG. 9 is a view like FIG. 8 showing the heat seal tools welding the film to the rims.
- FIG. 10 is an elevation cross-sectional view taken along section line X-X of FIG. 1 of the pre-heat station of the system of FIG. 1.
- FIG. 11 is an elevation cross-sectional view taken along section line XI-XI of FIG. 1 of the vacuum forming station of the system of FIG. 1.
- FIG. 12 is a cross-sectional view of the vacuum cavity of the vacuum forming station of FIG. 11.
- FIG. 13 is an elevation view of the unload station of the system of FIG. 1.
- FIG. 14 is a perspective view of a device produced by the system of FIG. 1.
- FIG. 15 is a perspective view of a preferred system for determining the orientation of the rims prior to being inserted into the carriers.
- FIG. 16 is an elevation view of the system of FIG. 15.
- FIG. 17 is a top view of the system of FIG. 15.
- FIG. 18 is top view of a preferred system for determining the roundness-and flatness of the rims prior to being inserted into the carriers.
- FIG. 19 is an elevation sectional view of an apparatus for testing the finished devices for defects.
- FIG. 20 is a top view of a second embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 21 is a plan view of another embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- a device 214 (see FIG. 14) having an elastomeric rim 200 and a thin, vacuum-formed, film reservoir 202 attached to the rim 200 will now be described.
- the embodiment shown in the figures is especially adaptable for menstrual fluid collection.
- the rim 200 is injection molded in a sixteen cavity injection mold with a hot runner system and small heated gates that leave vestiges 218 (see FIGS. 8 and 9) formed on one side of the rim 200 , which give the rim 200 an orientation.
- the molding operation may leave between 2 and 8 gate vestiges on the molded rim 200 (2 gate vestiges being shown in FIGS. 8 and 9).
- the reservoir 202 is made from a sheet of elastomeric film 204 .
- the film 204 is manufactured by a flat die processor and delivered to the manufacturing facility of the present invention in rolls 42 .
- FIGS. 1 and 2 there being shown a preferred embodiment of a manufacturing system according to the present invention.
- the manufacturing system of FIG. 1 includes five stations: the load station 20 , the heat seal station 40 , the pre-heat station 60 , the vacuum forming station 80 and the unload station 100 .
- the manufacturing system is controlled by two programmable logic controllers (PLC) 10 which sequence the actions of the equipment. These activities may be automated or actuated at various points by operator controls.
- PLC programmable logic controllers
- FIG. 1 shows the stations being arranged in a carousel connected by a conveyor 12 having a pair of chain assemblies 14 that carry the carrier plate 16 .
- FIG. 2 shows the station being arranged in a line in which a walking beam system 317 carries the carrier plate 16 to each station: the heat seal station 340 , the pre-heat station 360 , the vacuum forming station 380 , and the unload station 400 .
- Elevators 320 are located at each ends of the line of FIG. 2, which raise and lower the carrier plate 16 . The elevators 320 enable some of the stations to be stacked above others, which conserves floor space in the factory.
- FIG. 20 shows a top view of the station of FIG. 2.
- FIG. 21 shows a plan view of another embodiment of the invention where the rims 200 are fed onto the carrier plates 16 by loading the rims 200 onto two separate carrier plates 16 at one time before the carrier plate 16 proceeds to each station.
- the rims 200 are poured into a trough shaped pre-feeder 522 before traveling to a pair of centrifugal feeders 524 .
- the centrifugal feeders 524 discharge the rims 200 into a pair of lanes 526 in a flat orientation for insertion into the carrier plates 16 .
- the assembly may include a device (not shown) for inspecting the rims 200 prior to insertion into the carrier plates 16 to determine the roundness, flatness and orientation of the rims 200 .
- the carrier plate 16 may be conveyed to each of the manufacturing stations by the conveying arrangement of either FIG. 1 or FIG. 2, as well as by others known in the art.
- FIG. 1 shows that the carrier plate 16 of the present invention is square, and sized to accommodate a plurality of devices.
- the carrier plate 16 is approximately 36 inches by 36 inches and approximately 0.3125 inches thick.
- One hundred holes 18 are formed in the carrier plate in ten rows of ten. The diameter of the holes 18 is designed to produce a friction fit between the rims 200 and the holes 18 when the rims 200 are inserted into the holes 18 . As seen in FIGS. 3 and 4, the holes 18 extend through the entire carrier plate 16 .
- the carrier plate 16 includes annular ridges 19 around each hole 18 .
- a recess 15 is defined between the annular ridges 19 .
- the depth of the recess and the height of the ridges are dimensioned such that a lower stripper plate 58 fits within the recess and the ridges 19 lend support to the rims 200 during the heat sealing process.
- the rims 200 are poured into a trough-shaped pre-feeder 22 at the load station 20 .
- the rims 200 then travel to a pair of centrifugal feeders 24 which discharge the rims 200 into a pair of lanes 26 in a flat orientation.
- the assembly may include a module 240 (shown in FIGS. 15 - 18 ) that inspects the rims 200 and diverts them such that they fall with the side including the vestige oriented upwards.
- the lanes 26 carry the rims 200 over to the carrier plate 16 which has been placed in position.
- FIG. 15 This figure shows a preferred embodiment where the assembly includes a module 240 that inspects the rims 200 and diverts them such that they fall with the vestige 218 oriented upwards.
- the rim 200 is molded with a series of protrusion 222 on the inside surface of the rim 200 .
- the protrusions 222 are not in the center of the inside surface, but are offset and aligned closer to one edge of the inside of the rim 200 .
- the protrusions 222 are located opposite the vestiges 218 .
- the protrusions 222 are sized and spaced to be sufficiently distinct to be detected by a vision detection system as discussed below.
- the protrusions 222 are spaced around the inside circumference of the rim 200 and are about 0.25 inches in length, about 0.0625 inches wide and have a height of from about 0.005 inches to about 0.010 inches.
- the rim 200 may include as many protrusions 222 as are required for efficient operation.
- the rim 200 includes about 10 protrusions 222 located along the interior circumference of the rim 200 .
- the protrusions 222 serve at lease two different purposes.
- the protrusions 222 facilitate the extraction of the molded rim 200 from the cavity in the molding operation to the core side to enhance efficient cycling of the molding operation of the rim 200 .
- the offset protrusions 222 are also recognizable by the video camera 241 and serve to differentiate one edge of the rim 200 from the other. Only one edge of the rim 200 has vestiges 218 and through this process all of the rims 200 will be oriented with the vestiges 218 facing the same direction. Detecting the protrusions 222 on the inside circumference of the rim 200 is important so that the rim 200 may be oriented such that the film 204 is welded onto the rim 200 where the vestiges 218 are present. This ensures that the vestiges 218 are not left exposed, which in some cases, if the vestiges 218 are present, may irritate the user.
- FIG. 15 To ensure that the rims 200 are properly oriented, reference is made to FIG. 15.
- the rims 200 are stood up on their edge in the elevating conveyors 242 and moved toward the camera 241 . As they move toward the camera 241 , the rims 200 are compressed to produce a flattened segment 243 which in the illustrated embodiment is about one and one-half inches long allowing the camera 241 to view the protrusions 222 on the interior circumference of the rims 200 .
- the camera 241 recognizes the position of the protrusions 222 on the inside circumference of the rim 200 and signals an orienting device 244 farther down the track which orients the rims 200 with the vestiges 218 pointed upward.
- the camera 241 preferably uses AcuytyTM software from IVS Express Vision to recognize the presence of the protrusions 222 , and therefore the orientation of the rim 200 and to contact the rotating vane 246 to orient the rims before placing them in the carrier plate 16 .
- FIGS. 16 and 17. show the rim 200 moving through the elevating conveyors 242 to a preferred orienting device 244 for orientating the rims 200 .
- the orienting device 244 preferably comprises a stationary vane 245 and a rotating vane 246 which is in contact with a rotary solenoid 248 .
- the rotary solenoid 248 senses the signal from the camera 241 and signals the rotating vane 246 to tip the rim 200 in a direction 247 so that the vestiges 218 are facing upward on the discharge conveyor 26 .
- the discharge conveyor 26 may include a wall 249 that maintains the rims 200 oriented in two rows for insertion in the carrier plate 16 .
- the module 240 includes an additional rim inspection device 260 (FIG. 18) to determine whether the rim 200 is within predetermined tolerances for both roundness and flatness.
- the rim inspection device 260 is preferably located after-the rim orienting device 244 .
- the rim inspection device 260 has a machine vision system 265 which views the rim 200 as the rim 200 moves along a conveyor 26 and a flatness detection device 267 .
- the rims 200 pass the rim inspection device 260 at a rate of about 300 to 400 per minute.
- the rim inspection device 260 inspects the rims 200 for both roundness and flatness. To inspect the rims 200 for roundness, each rim 200 is inspected by the machine vision system 265 .
- the machine vision system 265 includes a camera 261 which takes an electronic image of the rim 200 .
- the machine vision system 265 evaluates the rim 200 at several points to determine whether the rim 200 meets predetermined physical characteristics so that the rim 200 has sufficient roundness for use in the device 214 by comparing the electronic image obtained from the rim 200 to a predetermined range of acceptable images. If the rim 200 is determined to be insufficiently round for use in the device 214 , the rim 200 is discarded by an actuated air jet (not shown).
- the machine vision system 265 may use the AcuytyTM Intelligent Vision software as described above.
- the flatness detection device 267 includes a plurality of photocells 263 which scan across the top of the rim 200 as they move along the conveyor 26 .
- the photocell beam 262 is set at a predetermined height above the conveyor 26 .
- the photocells 263 scan across the conveyor 26 to a photocell receptor 264 . If a photocell beam 262 is broken, the rim inspection system 260 discards the rim 200 through the use of an actuated air jet (not shown).
- the rims 200 are singulated, or removed individually, either by a robotic arm 30 , as seen in FIG. 5, or by some other escapement device.
- the rims 200 are then inserted into the holes 18 of the carrier plate 16 .
- a robotic hand 34 may be used to take the rims 200 from the lanes 26 and insert them into the carrier plate 16 .
- stops 13 are formed on the conveyor 12 that index the carrier plate 16 two rows at a time so that the robotic arm 30 may insert two rows of rims 200 into the carrier plate 16 before the carrier plate 16 is moved to the next stop 13 .
- the rims 200 could be scooped from a singulated row and put into a coin changer type escapement which would manually place each rim 200 into a funnel that is aligned with the holes 18 in the carrier plate 16 and insertion rams may travel through the insertion chute to push the rims 200 into the holes 18 .
- the rims 200 are held in the carrier plate 16 by a friction fit, which prevents the rims 200 from falling out of the carrier plate 16 during the balance of the manufacturing process until the devices are formed and unloaded from the carrier plate 16 .
- the friction fit enables the rims 200 to be loaded into the carrier plate 16 from the top and unloaded through the bottom because it eliminates the need for a ledge formed within the hole 18 that could support the rims 200 . Because the holes 18 do not contain a ledge or any other protrusion, the rims 200 may be pushed all the way through the holes 18 .
- their motion in the X-Y direction see FIG. 6) is completely restricted.
- the heat seal station 40 includes a support table 59 , which supports the carrier plate 16 , a feeder mechanism 46 which advances the film 204 though the heat seal station 40 , and two film rolls 42 .
- the film is thin, approximately 0.011 inches, and is threaded through several cylinders 45 to create a slack loop 44 .
- the film 204 is threaded between an upper stripper plate 56 and a lower stripper plate 58 , which are spaced apart a sufficient distance to allow the film 204 to be threaded between them. In a preferred embodiment, this distance is about 0.25 inches.
- the film 204 is finally grasped by the feeder mechanism 46 .
- the film 204 that remains after the heat seal process, i.e., the scrim 206 is discarded into a scrap box 48 .
- the feeder mechanism 46 advances the film 204 such that a fresh portion of the film 204 is located above the carrier plate 16 .
- a lower stripper plate 58 having holes formed in it that are aligned with the position of the rims 200 within the annular ridges 19 , is then lowered to rest within the recess 15 of the carrier plate 16 , as seen in FIG. 8.
- Gravity pulls the film 204 downward so that the film 204 touches the lower stripper plate 58 and contacts the top of the rims 200 .
- the film 204 lies on the tops of the rims 200 such that it is essentially flat.
- An upper stripper plate 56 assists in keeping the film 204 in position.
- An array of heat seal tools 50 is then lowered though the upper stripper plate 56 to touch the film 204 , as seen in FIG. 9.
- Each heat seal tool 50 is dimensioned to position the pressure point of the tool 50 precisely on the rim shoulder 216 where there is relief for the edge of the tool 50 such that no vestige is formed by the weld.
- the flexibility and resiliency of the elastomeric rim 200 allows for wider tolerances in the alignment of the rims 200 with the weld tools 50 .
- the force from the heat seal tool transfers through the carrier plate 16 to the support table 59 , which supports the load. In a preferred embodiment, the carrier plate 16 does not support the load produced by the heat seal tool 50 .
- the heat seal tool 50 is heated by a cal rod style heater 52 with five heat seal tools 50 per bar.
- the heated bars are mounted to a water-cooler platen 54 .
- the heat seal tools 50 are maintained at approximately 360 degrees F.
- the heat seal tools 50 are lowered to extend through both the upper and lower stripper plates 56 , 58 , they touch the film 204 (FIG. 9) for about four seconds to weld the film 204 to the rims 200 .
- the welded combination of a rim 200 and the film 204 within the rim 200 is referred to as a drumhead 208 .
- the vestige 218 formed on the rim 200 is oriented upward, as seen in FIGS.
- the film 204 is sealed over it so that the vestige 218 is not visible and does not protrude from the rim 200 of the device 214 to irritate the vaginal canal.
- welding the film 204 to the vestige 218 side of the rim 200 produces a more comfortable, and thus, superior device 214 .
- the heat seal tools 50 remain in position while the stripper plates 56 , 58 are lifted together such that the film 204 not part of the drumheads 208 is severed from the rims 200 . This severing occurs because the film 204 around each heat seal tool 50 becomes molten as the tool 50 welds the film directly under the tool 50 to the rims 200 . In addition, the edges of the heat seal tools 50 are sharpened slightly.
- the heat seal tools 50 are then lifted up to retract the tools 50 through the stripper plates 56 , 58 .
- the upper stripper plate 56 removes any remaining film 204 from the heat seal tools 50 .
- the carrier plate 16 containing the newly formed drumheads 208 is then conveyed to the pre-heat station 60 .
- FIG. 10 showing the pre-heating station 60 .
- a pre-heating station is needed in order to raise the temperature of the drumheads 208 to the temperature necessary for effective vacuum extrusion.
- the drumheads should be about 250 degrees F. when they arrive at the vacuum forming station.
- the film 204 is known to cool very rapidly after removal from a heat source.
- the pre-heat station must be close to the vacuum forming station in order to minimize the transfer time between these stations. Low transfer time enables the pre-heating station to be maintained at a lower temperature, reduces the amount of time required in the pre-heating station and thus, the over all time of the manufacturing process, reduces the capacity of heater needed, and produces less heat waste.
- the pre-heat station 60 includes an infrared heater 62 which includes several heating elements encased by ceramic insulating material. The heating elements are spaced closely together to prevent uneven heating. A quartz radiating panel extends across the heating elements parallel to the carrier plate 16 . This panel diffuses the heat produced by the heating elements and reduces the chance of uneven heating. Uneven heating may hinder the formation of the reservoir during the vacuum forming step 80 because the temperature of the drumheads 208 should be uniform in order for the film 204 to be extruded properly.
- the temperature of the radiating panel is monitored with a thermocouple and is maintained in a preferred embodiment at about 1450 degrees F.
- the temperature of the drumheads 208 is regulated by the amount of time spent in the pre-heat station 60 and the distance between the radiating panel and the drumheads 208 . Heater mounts 64 are used to adjust the height of the radiating panel.
- the carrier plate 16 remains in the pre-heat station for approximately eight seconds. When the drumheads leave the pre-heat station 60 , they should be warm enough to be able to enter the vacuum forming station 80 at a temperature appropriate for proper vacuum formation. In a preferred embodiment, this temperature is approximately 270 degrees F. The carrier plate 16 is then conveyed to the vacuum forming station 80 rapidly in order to reduce the amount of heat loss.
- the pre-heat station 60 could be eliminated if a heated surface were placed inside the heat seal tool 50 which would touch both the film 204 and raise its temperature to the proper thermoforming temperature.
- the vacuum form station 80 includes one hundred vacuum form cavities 82 mounted to a stationary upper platen 84 in an arrangement of ten rows of ten to correspond to the hundred drumheads 208 .
- Each vacuum cavity 82 has vacuum holes 94 through which air is drawn to create a vacuum.
- each cavity 82 has five 0.015 inch diameter holes 94 .
- the holes 94 join together in an internal plenum 98 within the vacuum cavity 82 from which a single vacuum line (not shown) runs out of the individual cavity 82 .
- the vacuum line includes a sensor (not shown) that monitors whether a proper vacuum has been drawn within the individual cavity 82 and relays this information to the PLC's that control the manufacturing process.
- the vacuum cavities 82 are maintained at a temperature that reduces the likelihood of freeze-off and optimizes the effectiveness of the vacuum forming process. In a preferred embodiment, this temperature is approximately 150 degrees F.
- a water chiller or heater 86 is provided to chill or-heat the vacuum cavities 82 as needed.
- the vacuum forming station also includes one hundred mandrels 92 extending from a first lower platen 90 .
- the mandrels 92 are arranged in ten rows of ten and are aligned with the center of the vacuum cavities 82 .
- the mandrels 92 are maintained at approximately 220 degrees F, or between 20 and 30 degrees less than the film 204 of the drumheads 208 .
- a water chiller or heater 96 is provided to chill or heat the mandrels 92 as needed.
- the carrier plate 16 is raised by a second lower platen 88 and pressed to the vacuum cavities 82 to create a seal between each rim 200 and each vacuum cavity 82 .
- the rim 200 acts as its own o-ring as a result of the flexibility and resiliency produced by the formulation of the elastomeric material of which the rim 200 is made.
- the vacuum cavities 82 do not contact the carrier plate 16 .
- the first lower platen 90 is then raised to bring the mandrels into contact with the film 204 of the drumheads 208 at the center of the rims 200 . Since the film 204 temperature is greater than that of the mandrels 92 , the mandrels 92 act as heat sinks and cool the film 204 at the centers of the drumheads 208 .
- a vacuum is introduced into the vacuum cavities 82 about one to about one and one half seconds after the mandrels 92 contact the film 204 , as the first lower platen 90 begins to lower.
- the vacuum extrudes the film 204 into the cavities 82 and forms the reservoirs 202 .
- the film 204 at the centers of the drumheads 208 travels the farthest into the cavities 82 , it is important to cool this film 204 so that it does not stretch too thinly in reaction to the force produced by the vacuum. Because the center is cooler and does not stretch as much as the warmer portions of the film 204 , the sides of the film 204 must stretch more in order for the cavity 82 to be filled by the film 204 .
- the reservoirs 202 are produced with the proper thickness at their centers.
- maintaining the temperature of the vacuum cavity 82 prevents freeze-off and contributes to the accuracy of the thickness of the reservoir.
- the reservoir's 202 thickness varies from about 0.010-0.011 inches closest to the rim 200 , to about 0.004-0.007 inches at the shoulder 210 , to about 0.001-0.003 inches at the dimple 212 .
- the vacuum is discontinued and the second lower platen 88 is lowered.
- the whole vacuum forming operation should take between ten and fifteen seconds.
- the PLC notes the location of any vacuum cavity 82 that fails to produce a proper vacuum so that the device 214 in that location may be rejected at the unload station 100 .
- the carrier plate 16 is then conveyed to the unload station 100 .
- the device 214 is vacuum formed.
- the device 214 may be formed by other methods such as, physically forming the device with a mandrel or press type tool and/or creating a pressure differential between a first side of the film and a second side of the film 204 .
- the pressure differential formed between the first and second side of the film 204 may be at any combination of pressures above, below or at atmospheric pressure so long as there is a pressure differential between the first and second sides of the film 204 .
- the carrier plate 16 is positioned in the unload station 100 .
- a servo controlled positioner regulates the position of the carrier plate 16 and enables the PLC to determine whether a particular device 214 should be rejected.
- the unload station 100 includes a first discharge row 104 of rams 102 that are capable of moving vertically individually.
- the rams 102 are dimensioned to fit the rims 200 .
- the unload station 100 also includes a second discharge row (not shown) of rams (not shown) that move vertically in unison.
- the rams are dimensioned to fit the rims 200 .
- the carrier plate is positioned such that one of its ten rows of devices are under the first discharge row 104 .
- the PLC determines which devices 214 are acceptable and actuates the individual rams 102 corresponding to acceptable devices 204 .
- the rams 102 move vertically and push on the rims 200 to eject the acceptable devices 214 .
- the acceptable devices 214 fall onto a conveyor 106 and are carried to the packaging station (not shown).
- the carrier plate 16 then is positioned such that the first row of ten devices is under the second discharge row (not shown) and a second row of ten devices is positioned under the first discharge row 104 .
- the second discharge row moves its rams in unison to eject into a rejection bin 108 the remaining devices, which correspond to rejected devices whose vacuum sensor indicated that a proper vacuum was not maintained.
- the carrier plate 16 is again advanced until all ten rows of devices have traveled through both the first and second discharge rows.
- the unloading operation similarly could be programmed such that the rejected devices 214 are pushed out of the carrier plate 16 by the individually movable rams 102 on the first discharge row 104 and the acceptable devices 214 are ejected in unison. In either system, sensors are provided to assure that no devices 214 remain in the carrier plate 16 .
- FIG. 19 Another embodiment of the invention comprises using an automated inspection system 250 .
- the automated inspection system 250 is located along the manufacturing system after the vacuum forming system 80 .
- the automated inspection system 250 positions the carrier plate 16 between a press platen 252 and a support platen 254 .
- the automated inspection system 250 seals the bottom of the cup 214 .
- the cup 214 is sealed by engaging the rim 200 with the seal cup 255 to create a seal.
- Air is pumped into the cup 214 from the compressed air source 256 through air lines 257 . Air pressure is built up within each cup 214 .
- the compressed air source 256 is shut off by a valve 259 when the cup 214 has been administered a predetermined amount of air.
- a pressure transducer 258 measures the change in pressure in the cup 214 . Preferably the pressure is measured for several seconds. A loss of pressure indicates that a hole exists in the cup 214 .
- the cups 214 that exhibit a change in pressure measured by the pressure transducer 258 are identified and that information is passed to the ejection equipment in the unload station 100 .
- the chemical composition of the elastomeric material used in the above-described method and system for manufacturing elastomeric articles contributes to the manufacturing advantages.
- the elastomeric material should be capable of performing certain functions which may vary depending on the particular device that is being manufactured by the above-described method and depending on the particular use of the manufactured device. For example, when the device is used for intravaginal applications, certain physical characteristics are desired, as described below.
- use of the device for delivery of agents or substances such as, medicines, spermicide, anti-bacterial agents, and others, may be taken into account in determining the desired composition of the device.
- the material should produce a rim having a certain compression strength and hardness. Another important property of the rim material of such a device is its ability to relax and conform to the walls of the vagina as its temperature is increased from room temperature to body temperature.
- the compression hoop stress of a material refers to the self-restoring force of a device made of the material.
- compression hoop strength means the force needed to maintain diametrically opposed portions of the elastomeric rim 200 in contact with each other when the rim 200 of an intravaginal device is at room temperature.
- An appropriate compression hoop strength for the rims 200 of an intravaginal device is from about two hundred and fifty grams to about one thousand grams. At these values, the self-restoring force of the elastomeric rim 200 is great enough to ensure that the rim 200 will expand with enough strength to form the desired seal against the wall of the vaginal canal, and to ensure that the device 214 will not become inadvertently dislodged, but not so great that the device is difficult to insert the device 214 or for it to contribute to cramping or cause other discomforts.
- Hardness refers to the degree of stiffness of the material when it is in the shape of the rim 200 .
- the rim 200 of the intravaginal device described should be stiff enough to maintain its shape and provide the desired elastomeric self-restoring force and yet flexible enough to adjust comfortably to individual shapes.
- the preferred balance between stiffness and flexibility for the material of the rim 200 is obtained when the material has a Shore A hardness of approximately fifty five to approximately seventy five, preferably sixty to seventy, according to the following test method: ASTM D2240.
- TPE thermoplastic elastomer
- Low density polyethylene is a relatively hard and stiff material that provides stiffness to a blend, improves processibility, and is relatively inexpensive. Low density polyethylene enhances the weldability of the rim material to the reservoir material because polyethylene heat welds readily to itself. Since TPE's are relatively soft materials, their combination in appropriate proportions with low density polyethylene produces a blended material whose compression hoop strength and hardness vary depending on the amounts of polyethylene and TPE.
- TPE's have anisotropic flow properties, which means that its molecular chains can be caused to orient during plastic flow to increase stiffness perpendicular to the direction of injection molding. Without the anisotropic flow properties, it would be difficult to achieve the desired stiffness perpendicular to the injection molding direction.
- a preferred TPE is a styrenic-olefinic block copolymer marketed by Shell Chemical Company under the trademark “Kraton.”
- the ratio of polyethylene to the TPE may be adjusted to control the stiffness and flexibility of the rim 200 .
- a preferred ratio is about 1:2, polyethylene to TPE, but it may vary from about 50:50 to about 15:85. This material is preferred because it is toxicologically acceptable for internal wear, readily available, economical, and readily processible.
- the blend gives the rim 200 the proper springiness to maintain the friction fit within the carrier plate 16 and to provide a seal with the heat seal tool 50 and vacuum cavities 82 .
- the second elastomeric portion is a nonplanar film reservoir portion 202 that is thermoformed from a planar sheet of elastomeric material 204 , like in the embodiment described above, the elastomeric reservoir material should have many of the same performance characteristics as the rim material.
- the film 204 must be able to be welded easily and it must be toxicologically acceptable for internal wear.
- the sheet of film 204 for menstruation applications is approximately 0.011 inches thick but may be between about 0.007 and about 0.020 inches thick.
- the thickness of the film 204 may be different.
- the thickness of the film 204 may be somewhat greater.
- a planar sheet is used because it is easier to handle and weld onto the rim 200 than a thin nonplanar elastomeric component.
- the finished thin film reservoir for menstruation applications, is preferably approximately 0.002 inches thick at its thinnest point, but the thinnest portion's thickness may vary between about 0.002 and about 0.006 inches.
- the thickness of the film reservoir may be different.
- the thickness of the film reservoir may be somewhat greater. Therefore, if necessary, the film material should be able to be thermoformed to about twenty percent of its original thickness.
- TPE/low density polyethylene formulation Use of a TPE/low density polyethylene formulation is preferable for the film formulation for many of the same reasons described above.
- a low density polyethylene/TPE mixture is nontoxic and produces good weld characteristics when welding to the rim because polyethylene is readily heat welded to itself. Controlling the ratio of polyethylene to TPE produces a desired level of stiffness and flexibility. A preferred ratio is about 1:2 but it may vary from about 50:50 to about 15:85.
- the film 204 formulation also performs well in the thermoforming process because it may be drawn deeply within the vacuum cavity 82 without creating holes or thin spots. Other performance advantages of this material include the material's soft and fleshy feel which make the device more comfortable, its quiet performance when compressed or wrinkled. The components are also readily available and economical.
- thermoplastic elastomers could be used to make the devices 214 , but these compounds would not necessarily provide the superior and reliable welding characteristics, the economics, or the product performances found in the above-described formulations of the rim 200 and film 204 .
Abstract
A method of manufacturing a device having a first elastomeric portion and a second elastomeric portion, the second elastomeric portion being formed into a nonplanar shape, i.e., a vaginal discharge collection device that is formed of an elastomeric rim and a flexible film reservoir, including the steps of loading a rim into a carrier plate, laying film over the rim, heat sealing the film to the rim, preheating the rim and film, drawing the film into a chamber by creating a vacuum to form the collector, and removing the collector from the carrier plate.
Description
- This application claims the benefit of U.S. Provisional Application No. 60/021,236, filed Jul. 3, 1996.
- The present invention relates generally to a method and system for manufacturing elastomeric articles and more specifically to a method and system for manufacturing a device having a plurality of elastomeric portions, one of which is a relatively thin nonplanar portion and the other of which is a relatively thick portion, such as the devices of the types described in U.S. Pat. No. 5,295,984 for collecting vaginal discharge and/or vaginal delivery of substances such as medication, the entire disclosure of which is incorporated herein by reference.
- The system may be used, for example, to produce a particular product whose relatively thick portion may be an elastomeric rim and whose relatively thin portion may be a nonplanar thin elastomeric reservoir. In manufacturing methods of the prior art, devices of this type may be injection molded in one piece. For some devices, however, injection molding is inappropriate because the reservoir component must be a very thin film. In order to achieve this thinness, the reservoir may be vacuum-formed from a sheet of elastomeric material. A common method of producing a device whose reservoir is a very thin film is simply to attach a pre-formed reservoir to a separately formed rim. However, the pre-formed reservoir is difficult to manage because the very thin elastomeric film is fragile, sticks to itself and fails to retain its shape after it has been vacuum-formed.
- In one aspect of the invention, a plurality of first elastomeric portions is heat sealed to a second elastomeric portion having a planar form to create intermediate components that are subsequently placed in a vacuum mold in which the planar second elastomeric portion is formed to create a nonplanar thin portion.
- In one application of the present invention, a sheet of elastomeric film is heat sealed to a batch of elastomeric rims to create drumheads that are subsequently placed in a vacuum mold in which the film portion is vacuum formed from the drumheads to form reservoirs.
- It is an object of the present invention to provide a method of manufacturing a device having an elastomeric rim and a thin, flexible film reservoir attached to the rim.
- It is a further object of the present invention to provide a method of manufacturing a vaginal device.
- It is another object of the present invention to provide a method of manufacturing a device that is capable of delivering substances or other agents within the vagina.
- It is a further object of the present invention to provide a method of manufacturing a vaginal discharge collector.
- It is another object of the present invention to provide a method of mass producing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim.
- It is still a further object of the present invention to provide a method of manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim in which a film is first heat sealed to the rim before the vacuum-forming occurs.
- It is another object of the present invention to provide a method of manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim that monitors whether an appropriate vacuum was formed during the vacuum-forming step and applies this information to separate rejected devices from acceptable ones.
- It is an object of the present invention to provide a method for orienting the rims from the molding process such that each molded rim is identically positioned prior to the heat sealing and vacuum molding processes.
- It is another object of the present invention to provide a method for automatically testing the devices to determine the presence of manufacturing or material defects within the finished device.
- Other objects and advantages of the present invention will become apparent from the following detailed description and drawings which illustrate preferred embodiments of the present invention.
- FIG. 1 is a plan view of a preferred embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 2 is an elevation view of a second preferred embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 3 is a perspective view of part of a carrier plate used in the system of FIG. 1.
- FIG. 4 is a cross-sectional view taken along section line IV-IV of FIG. 3.
- FIG. 5 is a perspective view of the load station of the system of FIG. 1.
- FIG. 6 is a perspective view of the heat seal station of the system of FIG. 1.
- FIG. 7 is a blown-up perspective view of the heat seal station of FIG. 4.
- FIG. 8 is a cross-sectional view taken along section line VIII-VIII of FIG. 7.
- FIG. 9 is a view like FIG. 8 showing the heat seal tools welding the film to the rims.
- FIG. 10 is an elevation cross-sectional view taken along section line X-X of FIG. 1 of the pre-heat station of the system of FIG. 1.
- FIG. 11 is an elevation cross-sectional view taken along section line XI-XI of FIG. 1 of the vacuum forming station of the system of FIG. 1.
- FIG. 12 is a cross-sectional view of the vacuum cavity of the vacuum forming station of FIG. 11.
- FIG. 13 is an elevation view of the unload station of the system of FIG. 1.
- FIG. 14 is a perspective view of a device produced by the system of FIG. 1.
- FIG. 15 is a perspective view of a preferred system for determining the orientation of the rims prior to being inserted into the carriers.
- FIG. 16 is an elevation view of the system of FIG. 15.
- FIG. 17 is a top view of the system of FIG. 15.
- FIG. 18 is top view of a preferred system for determining the roundness-and flatness of the rims prior to being inserted into the carriers.
- FIG. 19 is an elevation sectional view of an apparatus for testing the finished devices for defects.
- FIG. 20 is a top view of a second embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- FIG. 21 is a plan view of another embodiment of a system for manufacturing a device having an elastomeric rim and a thin, vacuum-formed, film reservoir attached to the rim according to the present invention.
- The method of manufacturing a device214 (see FIG. 14) having an
elastomeric rim 200 and a thin, vacuum-formed,film reservoir 202 attached to therim 200 will now be described. The embodiment shown in the figures is especially adaptable for menstrual fluid collection. For other types of applications, it may be desirable to use appropriate materials and appropriately shaped vacuum forming apparatus so as to shape the devices to desirable forms, such as, for example those described in U.S. Pat. No. 5,295,984, depending upon the desired application, such as substance delivery. - The
rim 200 is injection molded in a sixteen cavity injection mold with a hot runner system and small heated gates that leave vestiges 218 (see FIGS. 8 and 9) formed on one side of therim 200, which give therim 200 an orientation. The molding operation may leave between 2 and 8 gate vestiges on the molded rim 200 (2 gate vestiges being shown in FIGS. 8 and 9). Thereservoir 202 is made from a sheet ofelastomeric film 204. Thefilm 204 is manufactured by a flat die processor and delivered to the manufacturing facility of the present invention inrolls 42. - Refer now to FIGS. 1 and 2, there being shown a preferred embodiment of a manufacturing system according to the present invention. The manufacturing system of FIG. 1 includes five stations: the
load station 20, theheat seal station 40, thepre-heat station 60, thevacuum forming station 80 and theunload station 100. The manufacturing system is controlled by two programmable logic controllers (PLC) 10 which sequence the actions of the equipment. These activities may be automated or actuated at various points by operator controls. - A
carrier plate 16 containing the devices travels through each station. FIG. 1 shows the stations being arranged in a carousel connected by aconveyor 12 having a pair ofchain assemblies 14 that carry thecarrier plate 16. FIG. 2 shows the station being arranged in a line in which awalking beam system 317 carries thecarrier plate 16 to each station: theheat seal station 340, thepre-heat station 360, thevacuum forming station 380, and theunload station 400.Elevators 320 are located at each ends of the line of FIG. 2, which raise and lower thecarrier plate 16. Theelevators 320 enable some of the stations to be stacked above others, which conserves floor space in the factory. FIG. 20 shows a top view of the station of FIG. 2. - FIG. 21 shows a plan view of another embodiment of the invention where the
rims 200 are fed onto thecarrier plates 16 by loading therims 200 onto twoseparate carrier plates 16 at one time before thecarrier plate 16 proceeds to each station. Therims 200 are poured into a trough shaped pre-feeder 522 before traveling to a pair ofcentrifugal feeders 524. Thecentrifugal feeders 524 discharge therims 200 into a pair oflanes 526 in a flat orientation for insertion into thecarrier plates 16. The assembly may include a device (not shown) for inspecting therims 200 prior to insertion into thecarrier plates 16 to determine the roundness, flatness and orientation of therims 200. - The
carrier plate 16 may be conveyed to each of the manufacturing stations by the conveying arrangement of either FIG. 1 or FIG. 2, as well as by others known in the art. - FIG. 1 shows that the
carrier plate 16 of the present invention is square, and sized to accommodate a plurality of devices. In a preferred embodiment, thecarrier plate 16 is approximately 36 inches by 36 inches and approximately 0.3125 inches thick. One hundredholes 18 are formed in the carrier plate in ten rows of ten. The diameter of theholes 18 is designed to produce a friction fit between therims 200 and theholes 18 when therims 200 are inserted into theholes 18. As seen in FIGS. 3 and 4, theholes 18 extend through theentire carrier plate 16. Thecarrier plate 16 includesannular ridges 19 around eachhole 18. Arecess 15 is defined between theannular ridges 19. The depth of the recess and the height of the ridges are dimensioned such that alower stripper plate 58 fits within the recess and theridges 19 lend support to therims 200 during the heat sealing process. - The
rims 200 are poured into a trough-shaped pre-feeder 22 at theload station 20. Therims 200 then travel to a pair ofcentrifugal feeders 24 which discharge therims 200 into a pair oflanes 26 in a flat orientation. The assembly may include a module 240 (shown in FIGS. 15-18) that inspects therims 200 and diverts them such that they fall with the side including the vestige oriented upwards. Thelanes 26 carry therims 200 over to thecarrier plate 16 which has been placed in position. - Refer now to FIG. 15. This figure shows a preferred embodiment where the assembly includes a
module 240 that inspects therims 200 and diverts them such that they fall with thevestige 218 oriented upwards. Therim 200 is molded with a series ofprotrusion 222 on the inside surface of therim 200. Theprotrusions 222 are not in the center of the inside surface, but are offset and aligned closer to one edge of the inside of therim 200. In the illustrated embodiment, theprotrusions 222 are located opposite thevestiges 218. Theprotrusions 222 are sized and spaced to be sufficiently distinct to be detected by a vision detection system as discussed below. In the illustrated embodiment, theprotrusions 222 are spaced around the inside circumference of therim 200 and are about 0.25 inches in length, about 0.0625 inches wide and have a height of from about 0.005 inches to about 0.010 inches. Therim 200 may include asmany protrusions 222 as are required for efficient operation. Preferably, therim 200 includes about 10protrusions 222 located along the interior circumference of therim 200. - The
protrusions 222 serve at lease two different purposes. Theprotrusions 222 facilitate the extraction of the moldedrim 200 from the cavity in the molding operation to the core side to enhance efficient cycling of the molding operation of therim 200. The offsetprotrusions 222 are also recognizable by thevideo camera 241 and serve to differentiate one edge of therim 200 from the other. Only one edge of therim 200 hasvestiges 218 and through this process all of therims 200 will be oriented with thevestiges 218 facing the same direction. Detecting theprotrusions 222 on the inside circumference of therim 200 is important so that therim 200 may be oriented such that thefilm 204 is welded onto therim 200 where thevestiges 218 are present. This ensures that thevestiges 218 are not left exposed, which in some cases, if thevestiges 218 are present, may irritate the user. - To ensure that the
rims 200 are properly oriented, reference is made to FIG. 15. Therims 200 are stood up on their edge in the elevatingconveyors 242 and moved toward thecamera 241. As they move toward thecamera 241, therims 200 are compressed to produce a flattenedsegment 243 which in the illustrated embodiment is about one and one-half inches long allowing thecamera 241 to view theprotrusions 222 on the interior circumference of therims 200. Thecamera 241 recognizes the position of theprotrusions 222 on the inside circumference of therim 200 and signals anorienting device 244 farther down the track which orients therims 200 with thevestiges 218 pointed upward. Thecamera 241 preferably uses Acuyty™ software from IVS Express Vision to recognize the presence of theprotrusions 222, and therefore the orientation of therim 200 and to contact therotating vane 246 to orient the rims before placing them in thecarrier plate 16. - Further reference is made to FIGS. 16 and 17. These figures show the
rim 200 moving through the elevatingconveyors 242 to apreferred orienting device 244 for orientating therims 200. The orientingdevice 244 preferably comprises astationary vane 245 and arotating vane 246 which is in contact with arotary solenoid 248. Therotary solenoid 248 senses the signal from thecamera 241 and signals therotating vane 246 to tip therim 200 in adirection 247 so that thevestiges 218 are facing upward on thedischarge conveyor 26. Thedischarge conveyor 26 may include awall 249 that maintains therims 200 oriented in two rows for insertion in thecarrier plate 16. - In a preferred embodiment, the
module 240 includes an additional rim inspection device 260 (FIG. 18) to determine whether therim 200 is within predetermined tolerances for both roundness and flatness., Therim inspection device 260 is preferably located after-therim orienting device 244. Therim inspection device 260 has amachine vision system 265 which views therim 200 as therim 200 moves along aconveyor 26 and aflatness detection device 267. Preferably, therims 200 pass therim inspection device 260 at a rate of about 300 to 400 per minute. - The
rim inspection device 260 inspects therims 200 for both roundness and flatness. To inspect therims 200 for roundness, eachrim 200 is inspected by themachine vision system 265. Themachine vision system 265 includes acamera 261 which takes an electronic image of therim 200. Themachine vision system 265 evaluates therim 200 at several points to determine whether therim 200 meets predetermined physical characteristics so that therim 200 has sufficient roundness for use in thedevice 214 by comparing the electronic image obtained from therim 200 to a predetermined range of acceptable images. If therim 200 is determined to be insufficiently round for use in thedevice 214, therim 200 is discarded by an actuated air jet (not shown). Themachine vision system 265 may use the Acuyty™ Intelligent Vision software as described above. - The
flatness detection device 267 includes a plurality ofphotocells 263 which scan across the top of therim 200 as they move along theconveyor 26. Thephotocell beam 262 is set at a predetermined height above theconveyor 26. Thephotocells 263 scan across theconveyor 26 to aphotocell receptor 264. If aphotocell beam 262 is broken, therim inspection system 260 discards therim 200 through the use of an actuated air jet (not shown). - At this point the
rims 200 are singulated, or removed individually, either by arobotic arm 30, as seen in FIG. 5, or by some other escapement device. Therims 200 are then inserted into theholes 18 of thecarrier plate 16. Arobotic hand 34 may be used to take therims 200 from thelanes 26 and insert them into thecarrier plate 16. When arobotic arm 30 is used with aconveyor 12, stops 13 are formed on theconveyor 12 that index thecarrier plate 16 two rows at a time so that therobotic arm 30 may insert two rows ofrims 200 into thecarrier plate 16 before thecarrier plate 16 is moved to thenext stop 13. In the alternative, rather than using a robotic arm arrangement, therims 200 could be scooped from a singulated row and put into a coin changer type escapement which would manually place eachrim 200 into a funnel that is aligned with theholes 18 in thecarrier plate 16 and insertion rams may travel through the insertion chute to push therims 200 into theholes 18. - In either case, the
rims 200 are held in thecarrier plate 16 by a friction fit, which prevents therims 200 from falling out of thecarrier plate 16 during the balance of the manufacturing process until the devices are formed and unloaded from thecarrier plate 16. The friction fit enables therims 200 to be loaded into thecarrier plate 16 from the top and unloaded through the bottom because it eliminates the need for a ledge formed within thehole 18 that could support therims 200. Because theholes 18 do not contain a ledge or any other protrusion, therims 200 may be pushed all the way through theholes 18. When therims 200 are within thecarrier plate 16, their motion in the X-Y direction (see FIG. 6) is completely restricted. - In the embodiment shown, after one hundred
rims 200 are inserted into thecarrier plate 16 so that all of theholes 18 contain arim 200, theplate 16 is conveyed to theheat seal station 40. Refer now to FIGS. 6-9. Theheat seal station 40 includes a support table 59, which supports thecarrier plate 16, afeeder mechanism 46 which advances thefilm 204 though theheat seal station 40, and two film rolls 42. The film is thin, approximately 0.011 inches, and is threaded throughseveral cylinders 45 to create aslack loop 44. Then, thefilm 204 is threaded between anupper stripper plate 56 and alower stripper plate 58, which are spaced apart a sufficient distance to allow thefilm 204 to be threaded between them. In a preferred embodiment, this distance is about 0.25 inches. Thefilm 204 is finally grasped by thefeeder mechanism 46. Thefilm 204 that remains after the heat seal process, i.e., thescrim 206, is discarded into ascrap box 48. - When the
carrier plate 16 is positioned on the support table 59, thefeeder mechanism 46 advances thefilm 204 such that a fresh portion of thefilm 204 is located above thecarrier plate 16. Alower stripper plate 58, having holes formed in it that are aligned with the position of therims 200 within theannular ridges 19, is then lowered to rest within therecess 15 of thecarrier plate 16, as seen in FIG. 8. Gravity pulls thefilm 204 downward so that thefilm 204 touches thelower stripper plate 58 and contacts the top of therims 200. Thefilm 204 lies on the tops of therims 200 such that it is essentially flat. Anupper stripper plate 56 assists in keeping thefilm 204 in position. - An array of
heat seal tools 50, also referred to as weld tools, is then lowered though theupper stripper plate 56 to touch thefilm 204, as seen in FIG. 9. Eachheat seal tool 50 is dimensioned to position the pressure point of thetool 50 precisely on therim shoulder 216 where there is relief for the edge of thetool 50 such that no vestige is formed by the weld. The flexibility and resiliency of theelastomeric rim 200 allows for wider tolerances in the alignment of therims 200 with theweld tools 50. The force from the heat seal tool transfers through thecarrier plate 16 to the support table 59, which supports the load. In a preferred embodiment, thecarrier plate 16 does not support the load produced by theheat seal tool 50. - As seen in FIG. 7, the
heat seal tool 50 is heated by a calrod style heater 52 with fiveheat seal tools 50 per bar. The heated bars are mounted to a water-cooler platen 54. Theheat seal tools 50 are maintained at approximately 360 degrees F. When theheat seal tools 50 are lowered to extend through both the upper andlower stripper plates film 204 to therims 200. The welded combination of arim 200 and thefilm 204 within therim 200 is referred to as adrumhead 208. When thevestige 218 formed on therim 200 is oriented upward, as seen in FIGS. 8 and 9, thefilm 204 is sealed over it so that thevestige 218 is not visible and does not protrude from therim 200 of thedevice 214 to irritate the vaginal canal. Thus, welding thefilm 204 to thevestige 218 side of therim 200 produces a more comfortable, and thus,superior device 214. - After the weld is formed, the
heat seal tools 50 remain in position while thestripper plates film 204 not part of thedrumheads 208 is severed from therims 200. This severing occurs because thefilm 204 around eachheat seal tool 50 becomes molten as thetool 50 welds the film directly under thetool 50 to therims 200. In addition, the edges of theheat seal tools 50 are sharpened slightly. Theheat seal tools 50 are then lifted up to retract thetools 50 through thestripper plates upper stripper plate 56 removes any remainingfilm 204 from theheat seal tools 50. Thecarrier plate 16 containing the newly formeddrumheads 208 is then conveyed to thepre-heat station 60. - Refer now to FIG. 10 showing the pre-heating
station 60. A pre-heating station is needed in order to raise the temperature of thedrumheads 208 to the temperature necessary for effective vacuum extrusion. In a preferred embodiment, the drumheads should be about 250 degrees F. when they arrive at the vacuum forming station. Thefilm 204 is known to cool very rapidly after removal from a heat source. As a result, the pre-heat station must be close to the vacuum forming station in order to minimize the transfer time between these stations. Low transfer time enables the pre-heating station to be maintained at a lower temperature, reduces the amount of time required in the pre-heating station and thus, the over all time of the manufacturing process, reduces the capacity of heater needed, and produces less heat waste. - The
pre-heat station 60 includes aninfrared heater 62 which includes several heating elements encased by ceramic insulating material. The heating elements are spaced closely together to prevent uneven heating. A quartz radiating panel extends across the heating elements parallel to thecarrier plate 16. This panel diffuses the heat produced by the heating elements and reduces the chance of uneven heating. Uneven heating may hinder the formation of the reservoir during thevacuum forming step 80 because the temperature of thedrumheads 208 should be uniform in order for thefilm 204 to be extruded properly. The temperature of the radiating panel is monitored with a thermocouple and is maintained in a preferred embodiment at about 1450 degrees F. The temperature of thedrumheads 208 is regulated by the amount of time spent in thepre-heat station 60 and the distance between the radiating panel and thedrumheads 208. Heater mounts 64 are used to adjust the height of the radiating panel. - The
carrier plate 16 remains in the pre-heat station for approximately eight seconds. When the drumheads leave thepre-heat station 60, they should be warm enough to be able to enter thevacuum forming station 80 at a temperature appropriate for proper vacuum formation. In a preferred embodiment, this temperature is approximately 270 degrees F. Thecarrier plate 16 is then conveyed to thevacuum forming station 80 rapidly in order to reduce the amount of heat loss. - The
pre-heat station 60 could be eliminated if a heated surface were placed inside theheat seal tool 50 which would touch both thefilm 204 and raise its temperature to the proper thermoforming temperature. - Refer now to FIGS. 11 and 12. The
vacuum form station 80 includes one hundredvacuum form cavities 82 mounted to a stationaryupper platen 84 in an arrangement of ten rows of ten to correspond to the hundreddrumheads 208. Eachvacuum cavity 82 has vacuum holes 94 through which air is drawn to create a vacuum. In a preferred embodiment, eachcavity 82 has five 0.015 inch diameter holes 94. Theholes 94 join together in aninternal plenum 98 within thevacuum cavity 82 from which a single vacuum line (not shown) runs out of theindividual cavity 82. The vacuum line includes a sensor (not shown) that monitors whether a proper vacuum has been drawn within theindividual cavity 82 and relays this information to the PLC's that control the manufacturing process. The vacuum cavities 82 are maintained at a temperature that reduces the likelihood of freeze-off and optimizes the effectiveness of the vacuum forming process. In a preferred embodiment, this temperature is approximately 150 degrees F. A water chiller orheater 86 is provided to chill or-heat thevacuum cavities 82 as needed. - The vacuum forming station also includes one hundred
mandrels 92 extending from a firstlower platen 90. Themandrels 92 are arranged in ten rows of ten and are aligned with the center of thevacuum cavities 82. Themandrels 92 are maintained at approximately 220 degrees F, or between 20 and 30 degrees less than thefilm 204 of thedrumheads 208. A water chiller orheater 96 is provided to chill or heat themandrels 92 as needed. - The
carrier plate 16 is raised by a secondlower platen 88 and pressed to thevacuum cavities 82 to create a seal between eachrim 200 and eachvacuum cavity 82. Therim 200 acts as its own o-ring as a result of the flexibility and resiliency produced by the formulation of the elastomeric material of which therim 200 is made. The vacuum cavities 82 do not contact thecarrier plate 16. The firstlower platen 90 is then raised to bring the mandrels into contact with thefilm 204 of thedrumheads 208 at the center of therims 200. Since thefilm 204 temperature is greater than that of themandrels 92, themandrels 92 act as heat sinks and cool thefilm 204 at the centers of thedrumheads 208. - A vacuum is introduced into the
vacuum cavities 82 about one to about one and one half seconds after themandrels 92 contact thefilm 204, as the firstlower platen 90 begins to lower. The vacuum extrudes thefilm 204 into thecavities 82 and forms thereservoirs 202. Because thefilm 204 at the centers of thedrumheads 208 travels the farthest into thecavities 82, it is important to cool thisfilm 204 so that it does not stretch too thinly in reaction to the force produced by the vacuum. Because the center is cooler and does not stretch as much as the warmer portions of thefilm 204, the sides of thefilm 204 must stretch more in order for thecavity 82 to be filled by thefilm 204. Thus, thereservoirs 202 are produced with the proper thickness at their centers. In addition, maintaining the temperature of thevacuum cavity 82 prevents freeze-off and contributes to the accuracy of the thickness of the reservoir. In one application of a preferred embodiment of thevacuum forming station 80, the reservoir's 202 thickness varies from about 0.010-0.011 inches closest to therim 200, to about 0.004-0.007 inches at theshoulder 210, to about 0.001-0.003 inches at thedimple 212. - After a predetermined time, the vacuum is discontinued and the second
lower platen 88 is lowered. The whole vacuum forming operation should take between ten and fifteen seconds. The PLC notes the location of anyvacuum cavity 82 that fails to produce a proper vacuum so that thedevice 214 in that location may be rejected at the unloadstation 100. Thecarrier plate 16 is then conveyed to the unloadstation 100. - As described above the
device 214 is vacuum formed. However, thedevice 214 may be formed by other methods such as, physically forming the device with a mandrel or press type tool and/or creating a pressure differential between a first side of the film and a second side of thefilm 204. The pressure differential formed between the first and second side of thefilm 204 may be at any combination of pressures above, below or at atmospheric pressure so long as there is a pressure differential between the first and second sides of thefilm 204. Further, when thedevice 214 is formed through a pressure differential, there may be created such a pressure differential so that thedevice 214 is formed by pushing or pulling thefilm 204 to form thedevice 214. - Refer now to FIG. 13. The
carrier plate 16 is positioned in the unloadstation 100. A servo controlled positioner regulates the position of thecarrier plate 16 and enables the PLC to determine whether aparticular device 214 should be rejected. The unloadstation 100 includes afirst discharge row 104 oframs 102 that are capable of moving vertically individually. Therams 102 are dimensioned to fit therims 200. The unloadstation 100 also includes a second discharge row (not shown) of rams (not shown) that move vertically in unison. The rams are dimensioned to fit therims 200. - The carrier plate is positioned such that one of its ten rows of devices are under the
first discharge row 104. The PLC determines whichdevices 214 are acceptable and actuates theindividual rams 102 corresponding toacceptable devices 204. Therams 102 move vertically and push on therims 200 to eject theacceptable devices 214. Theacceptable devices 214 fall onto aconveyor 106 and are carried to the packaging station (not shown). Thecarrier plate 16 then is positioned such that the first row of ten devices is under the second discharge row (not shown) and a second row of ten devices is positioned under thefirst discharge row 104. The second discharge row (not shown) moves its rams in unison to eject into arejection bin 108 the remaining devices, which correspond to rejected devices whose vacuum sensor indicated that a proper vacuum was not maintained. Thecarrier plate 16 is again advanced until all ten rows of devices have traveled through both the first and second discharge rows. The unloading operation similarly could be programmed such that the rejecteddevices 214 are pushed out of thecarrier plate 16 by the individuallymovable rams 102 on thefirst discharge row 104 and theacceptable devices 214 are ejected in unison. In either system, sensors are provided to assure that nodevices 214 remain in thecarrier plate 16. - Refer now to FIG. 19. Another embodiment of the invention comprises using an
automated inspection system 250. Theautomated inspection system 250 is located along the manufacturing system after thevacuum forming system 80. Theautomated inspection system 250 positions thecarrier plate 16 between apress platen 252 and asupport platen 254. When thecarrier plate 16 is positioned between thepress platen 252 and thesupport platen 254 theautomated inspection system 250 seals the bottom of thecup 214. Thecup 214 is sealed by engaging therim 200 with theseal cup 255 to create a seal. Air is pumped into thecup 214 from the compressedair source 256 throughair lines 257. Air pressure is built up within eachcup 214. Thecompressed air source 256 is shut off by avalve 259 when thecup 214 has been administered a predetermined amount of air. Apressure transducer 258 measures the change in pressure in thecup 214. Preferably the pressure is measured for several seconds. A loss of pressure indicates that a hole exists in thecup 214. Thecups 214 that exhibit a change in pressure measured by thepressure transducer 258 are identified and that information is passed to the ejection equipment in the unloadstation 100. - The chemical composition of the elastomeric material used in the above-described method and system for manufacturing elastomeric articles contributes to the manufacturing advantages. In addition to having certain characteristics to improve manufacturability, the elastomeric material should be capable of performing certain functions which may vary depending on the particular device that is being manufactured by the above-described method and depending on the particular use of the manufactured device. For example, when the device is used for intravaginal applications, certain physical characteristics are desired, as described below. In addition, use of the device for delivery of agents or substances such as, medicines, spermicide, anti-bacterial agents, and others, may be taken into account in determining the desired composition of the device.
- When the first elastomeric portion is the
rim 200 of the vaginal device described above, which may be used as a vaginal discharge collector, the material should produce a rim having a certain compression strength and hardness. Another important property of the rim material of such a device is its ability to relax and conform to the walls of the vagina as its temperature is increased from room temperature to body temperature. The compression hoop stress of a material refers to the self-restoring force of a device made of the material. As used herein, the term “compression hoop strength” means the force needed to maintain diametrically opposed portions of theelastomeric rim 200 in contact with each other when therim 200 of an intravaginal device is at room temperature. An appropriate compression hoop strength for therims 200 of an intravaginal device is from about two hundred and fifty grams to about one thousand grams. At these values, the self-restoring force of theelastomeric rim 200 is great enough to ensure that therim 200 will expand with enough strength to form the desired seal against the wall of the vaginal canal, and to ensure that thedevice 214 will not become inadvertently dislodged, but not so great that the device is difficult to insert thedevice 214 or for it to contribute to cramping or cause other discomforts. - Hardness refers to the degree of stiffness of the material when it is in the shape of the
rim 200. Therim 200 of the intravaginal device described should be stiff enough to maintain its shape and provide the desired elastomeric self-restoring force and yet flexible enough to adjust comfortably to individual shapes. The preferred balance between stiffness and flexibility for the material of therim 200 is obtained when the material has a Shore A hardness of approximately fifty five to approximately seventy five, preferably sixty to seventy, according to the following test method: ASTM D2240. - One way to produce an elastomeric portion having these characteristics would be to mix polyethylene with a thermoplastic elastomer (TPE). Low density polyethylene is a relatively hard and stiff material that provides stiffness to a blend, improves processibility, and is relatively inexpensive. Low density polyethylene enhances the weldability of the rim material to the reservoir material because polyethylene heat welds readily to itself. Since TPE's are relatively soft materials, their combination in appropriate proportions with low density polyethylene produces a blended material whose compression hoop strength and hardness vary depending on the amounts of polyethylene and TPE. For example, TPE's have anisotropic flow properties, which means that its molecular chains can be caused to orient during plastic flow to increase stiffness perpendicular to the direction of injection molding. Without the anisotropic flow properties, it would be difficult to achieve the desired stiffness perpendicular to the injection molding direction.
- A preferred TPE is a styrenic-olefinic block copolymer marketed by Shell Chemical Company under the trademark “Kraton.” The ratio of polyethylene to the TPE may be adjusted to control the stiffness and flexibility of the
rim 200. A preferred ratio is about 1:2, polyethylene to TPE, but it may vary from about 50:50 to about 15:85. This material is preferred because it is toxicologically acceptable for internal wear, readily available, economical, and readily processible. In addition, the blend gives therim 200 the proper springiness to maintain the friction fit within thecarrier plate 16 and to provide a seal with theheat seal tool 50 andvacuum cavities 82. - When the second elastomeric portion is a nonplanar
film reservoir portion 202 that is thermoformed from a planar sheet ofelastomeric material 204, like in the embodiment described above, the elastomeric reservoir material should have many of the same performance characteristics as the rim material. For example, thefilm 204 must be able to be welded easily and it must be toxicologically acceptable for internal wear. The sheet offilm 204 for menstruation applications is approximately 0.011 inches thick but may be between about 0.007 and about 0.020 inches thick. For other applications the thickness of thefilm 204 may be different. For example, for substance delivery applications, the thickness of thefilm 204 may be somewhat greater. A planar sheet is used because it is easier to handle and weld onto therim 200 than a thin nonplanar elastomeric component. The finished thin film reservoir, for menstruation applications, is preferably approximately 0.002 inches thick at its thinnest point, but the thinnest portion's thickness may vary between about 0.002 and about 0.006 inches. For other applications the thickness of the film reservoir may be different. For example, for substance delivery applications, the thickness of the film reservoir may be somewhat greater. Therefore, if necessary, the film material should be able to be thermoformed to about twenty percent of its original thickness. - Use of a TPE/low density polyethylene formulation is preferable for the film formulation for many of the same reasons described above. A low density polyethylene/TPE mixture is nontoxic and produces good weld characteristics when welding to the rim because polyethylene is readily heat welded to itself. Controlling the ratio of polyethylene to TPE produces a desired level of stiffness and flexibility. A preferred ratio is about 1:2 but it may vary from about 50:50 to about 15:85. The
film 204 formulation also performs well in the thermoforming process because it may be drawn deeply within thevacuum cavity 82 without creating holes or thin spots. Other performance advantages of this material include the material's soft and fleshy feel which make the device more comfortable, its quiet performance when compressed or wrinkled. The components are also readily available and economical. - Other types of thermoplastic elastomers could be used to make the
devices 214, but these compounds would not necessarily provide the superior and reliable welding characteristics, the economics, or the product performances found in the above-described formulations of therim 200 andfilm 204. - The above description and drawings are only illustrative of preferred embodiments of the present invention, and it is not intended that the present invention be limited thereto. Any modification of the present invention which comes within the spirit and scope of the following claims is to be considered part of the present invention.
Claims (24)
1. A method of manufacturing a device having a first elastomeric portion and a second elastomeric portion, said second elastomeric portion being formed into a nonplanar shape, said method comprising the steps of:
loading said first elastomeric portion into a carrier plate;
laying said second elastomeric portion over said first elastomeric portion;
heat sealing said second elastomeric portion to said first elastomeric portion;
preheating said first and second elastomeric portions;
drawing said second elastomeric portion into a chamber by creating a vacuum to form a nonplanar shape; and
removing the device from said carrier plate.
2. A method of manufacturing a vaginal discharge collector having a rim and a reservoir, said method comprising the steps of:
loading a rim into a carrier plate;
laying film over said rim;
heat sealing said film to said rim;
preheating said rim and film to approximately 290 degrees F. for approximately 8 seconds;
conveying said carrier plate into a vacuum chamber while maintaining said rim and film at an approximate temperature of 250 degrees F.;
elevating a second lower platen containing at least one mandrel heated to approximately 220 degrees F. which comes into contact with a center portion of said film;
cooling said center portion of said film with said mandrel;
drawing said film into said chamber by creating a vacuum to form the reservoir; and
removing the collector from said carrier plate.
3. The method of claim 2 , wherein said rim is formed by an injection molding process.
4. The method of claim 3 , wherein said rim is molded in a injection mold cavity comprising a hot runner system and small heated gates that leave at least one vestige formed on one side of said rim.
5. The method of claim 2 , wherein said rim has a compression hoop strength from about two hundred and fifty grams to about one thousand grams.
6. The method of claim 2 , wherein said rim has a Shore A hardness of approximately fifty five to approximately seventy five.
7. The method according to claim 6 , wherein said rim comprises polyethylene and a thermoplastic elastomer.
8. An apparatus for the manufacture of a device having an elastomeric rim and a first elastomeric portion, said first elastomeric portion being formed in a nonplanar shape, said apparatus comprising:
a load station for loading said elastomeric rim onto a carrier plate;
a heat seal station for applying said first elastomeric portion to said elastomeric rim;
a preheat station to raise the temperature of said elastomeric rim and said first elastomeric portion from a first temperature to a second temperature;
a forming station for forming the first elastomeric portion of the device into a nonplanar shape; and
an unloading station for unloading said device.
9. The apparatus according to claim 8 , wherein said forming station is a vacuum form station for vacuum extracting the first elastomeric portion into a nonplanar shape.
10. The apparatus according to claim 9 , wherein said elastomeric rim is held in the carrier plate by a friction fit.
11. The apparatus according to claim 10 , wherein the carrier plate frictionally contacts the outer surface of said elastomeric rim.
12. The apparatus according to claim 11 , wherein the carrier plate has openings at the top and bottom of said elastomeric rim.
13. The apparatus according to claim 8 , wherein said loading station comprises a means to orient said elastomeric rim for placement into said carrier plate.
14. The apparatus according to claim 13 , wherein said means to orient said elastomeric rim comprises visual inspection means to orient said elastomeric rim so that a vestige formed on said elastomeric rim during the molding process are oriented in a predetermined direction.
15. The apparatus according to claim 14 , wherein said visual inspection means is arranged to visually inspect said elastomeric rim and relay a signal to an orienting device so that said elastomeric rim is oriented with the vestige facing upward in said carrier plate.
16. The apparatus according to claim 15 , wherein said visual inspection means includes a camera.
17. The apparatus according to claim 14 , wherein said apparatus additionally includes means to inspect the flatness and roundness of said elastomeric rims.
18. The apparatus according to claim 8 , wherein said first elastomeric portion is a film which is pulled over said carrier plate housing a plurality of said elastomeric rims.
19. The apparatus according to claim 18 , wherein said heat seal station comprises a means to weld said first elastomeric portion in a film to said elastomeric rim.
20. The apparatus according to claim 19 , wherein said heat seal station further comprises a means to cut the excess film away from said elastomeric rim.
21. The apparatus according to claim 20 , wherein said device is preheated from the first temperature to the second temperature in said pre-heat station while said first elastomeric portion is in the form of a film welded onto said elastomeric rim.
22. The apparatus according to claim 21 , wherein said first elastomeric portion is extracted into a nonplanar shape.
23. The apparatus according to claim 8 , wherein said apparatus additionally comprises a testing means to determine whether said device has been adequately formed.
24. The apparatus according to claim 23 , wherein said testing means comprise pressure testing means.
Priority Applications (1)
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US09/839,229 US20020020500A1 (en) | 1996-07-03 | 2001-04-23 | Method and system for manufacturing elastomeric articles |
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US2123696P | 1996-07-03 | 1996-07-03 | |
US08/886,010 US6241846B1 (en) | 1996-07-03 | 1997-07-03 | Apparatus for manufacturing elastomeric articles |
US09/839,229 US20020020500A1 (en) | 1996-07-03 | 2001-04-23 | Method and system for manufacturing elastomeric articles |
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DE69834568T2 (en) * | 1997-11-07 | 2007-05-03 | The Johns-Hopkins University | DEVICE FOR THE SIMULTANEOUS EXTRACTION OF ACTIVE SUBSTANCES IN THE CERVICAL AND VAGINAL CHANNEL |
WO2006058409A1 (en) * | 2004-09-23 | 2006-06-08 | Diva International Inc. | Menstrual cup |
US7845355B2 (en) * | 2005-05-19 | 2010-12-07 | Reprotect, Inc. | Intravaginal device with improved rim designs and methods of making same |
US8287270B2 (en) | 2009-09-30 | 2012-10-16 | Printpack Illinois Inc. | Methods and systems for thermoforming with billets |
DE102017101383A1 (en) * | 2017-01-25 | 2018-07-26 | Fun Factory Gmbh | Hygiene product, especially menstrual cup with ergonomic shape |
DE102019000523B4 (en) * | 2019-01-24 | 2021-12-09 | Illig Maschinenbau Gmbh & Co. Kg | Device and method for punching molded parts from thermoplastic plastic film |
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-
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- 1997-07-03 JP JP50441098A patent/JP4303788B2/en not_active Expired - Lifetime
- 1997-07-03 KR KR1019980710902A patent/KR20000022465A/en not_active Application Discontinuation
- 1997-07-03 BR BR9715048A patent/BR9715048A/en not_active Application Discontinuation
- 1997-07-03 AU AU35885/97A patent/AU732781B2/en not_active Expired
- 1997-07-03 EP EP97932423A patent/EP0921826A4/en not_active Ceased
- 1997-07-03 US US08/886,010 patent/US6241846B1/en not_active Expired - Lifetime
- 1997-07-03 IL IL12788097A patent/IL127880A0/en unknown
- 1997-07-03 CA CA 2259506 patent/CA2259506C/en not_active Expired - Lifetime
- 1997-07-03 WO PCT/US1997/011464 patent/WO1998000184A1/en not_active Application Discontinuation
-
2001
- 2001-04-23 US US09/839,229 patent/US20020020500A1/en not_active Abandoned
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090133364A1 (en) * | 2007-11-27 | 2009-05-28 | William Michael Oliver | Sealer and Interchangeable Tooling Therefor |
US7614202B2 (en) | 2007-11-27 | 2009-11-10 | Atlas Vac Machine Co., Llc | Sealer and interchangeable tooling therefor |
US20120188208A1 (en) * | 2011-01-20 | 2012-07-26 | Breit Solutions, LLC | Interface enhancement component for use with electronic touch-screen devices |
Also Published As
Publication number | Publication date |
---|---|
US6241846B1 (en) | 2001-06-05 |
AU732781B2 (en) | 2001-04-26 |
CA2259506A1 (en) | 1998-01-08 |
EP0921826A1 (en) | 1999-06-16 |
BR9715048A (en) | 2001-01-16 |
CA2259506C (en) | 2006-12-19 |
AU3588597A (en) | 1998-01-21 |
JP4303788B2 (en) | 2009-07-29 |
KR20000022465A (en) | 2000-04-25 |
EP0921826A4 (en) | 2002-07-24 |
IL127880A0 (en) | 1999-10-28 |
JP2000514726A (en) | 2000-11-07 |
WO1998000184A1 (en) | 1998-01-08 |
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Legal Events
Date | Code | Title | Description |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |