Adhesive bonding and miscellaneous chemical manufacture – Methods – Surface bonding and/or assembly therefor
Reexamination Certificate
1998-11-02
2001-10-30
Mayes, Curtis (Department: 1734)
Adhesive bonding and miscellaneous chemical manufacture
Methods
Surface bonding and/or assembly therefor
C156S238000, C156S220000, C156S269000, C156S289000, C156S324000
Reexamination Certificate
active
06309500
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of continuous line manufacturing, and more particularly to the field of manufacturing laminated and contoured components on a continuous manufacturing line.
DESCRIPTION OF RELATED ART
Laminated devices or components are available in many forms for a variety of purposes. Wound dressings, surgical dressings, medical adhesives and other like medical devices are often laminated to provide a skin-contacting layer, a backing layer and a release sheet layer.
The skin-contacting layer is used as a dressing or adhesive function and may be comprised of a variety of materials depending on the purpose of the device. Exemplary materials include hydrocolloid adhesives, hydrogels, non-wovens, foams, etc. It may be advantageous to contour, or shape the skin-contacting layer to provide conformability.
The backing layer is often attached to the skin-contacting layer to provide a protective covering. The release sheet layer is attached to the skin-contacting layer on the side opposite the backing layer with a release coating to permit removal of the release sheet layer during application. Each layer may be composed of other layers, or sub-layers depending on the application for which the device is intended. For example, the skin-contacting layer may have an adhesive layer attached to a moisture-absorbing or moisture-removing layer, such as a foam or non-woven.
Examples of wound dressings and methods for manufacturing such dressings are taught by Chen (U.S. Pat. No. 3,339,546) and Samuelson (U.S. Pat. No. 4,867,748, issued Sep. 19, 1989).
Other medical devices that may be laminated for purposes of application or packaging include fixation wafers for prostheses (e.g. breast prostheses) and ostomy wafers. Other devices that may be laminated and contoured include inner-soles for shoes. Instead of a skin-contacting layer such devices may include shock-absorbing materials, such as foam, soft rubber or other suitable materials. These materials may be covered by protective plastic films such as, polypropylene, polyethylene, polyurethane, etc.
Laminated devices may be difficult to manufacture. Because such devices may be high-volume devices, the method used for their manufacture should be as efficient as possible. Incremental costs may be magnified substantially as the volume of devices increases. In the case of medical devices, the need to manufacture in clean room or other specially controlled environment further complicates the process. Clean rooms may be expensive to maintain, particularly for high-grade medical devices that must be manufactured in clean rooms.
In addition, devices that are contoured may be more difficult to manufacture. Such contouring may involve shaping the materials comprising the devices at elevated temperature. The shaping may be performed using methods that stress the materials to a point at or near the ability of the materials to maintain a useful structure. For example, wound dressings may have backing layers made of polyethylene films that provide a flexible and impermeable covering for the skin-contacting layer. These materials may not have the strength to permit shaping at elevated temperatures.
One method for manufacturing wound dressings having skin-contacting layers made of hydrocolloid-adhesive and gel-like adhesive taught by Jensen in U.S. Pat. No. 5,133,821 (hereinafter Jensen '821) uses an in-line, substantially continuous process that minimizes the time and energy needed to make the dressings. Jensen '821 teaches a method in which the adhesive layer is covered by a protective layer on one surface and a release sheet layer on the opposing surface. The layers are contoured at a contouring station to produce a first laminate. The first laminate is carried through a delaminating station, which removes the protective layer to expose the surface of the adhesive. The exposed surface is then covered by a carrier layer at a laminating station and cut into discrete wound dressings at a cutting station.
The advantage of using the process in Jensen '821 is that the adhesive layer is protected by a protective layer during the contouring. The protective layer is made of paper or polyester that is coated with silicone for easy release during the removal of the layer. The backing layer is applied after the contouring of the adhesive layer such that the backing layer is not subject to the forces applied to the adhesive during contouring nor to the elevated temperatures that may be required to perform the contouring.
One problem with the methods taught in Jensen '821 is that the adhesive layer is exposed during the process. Because the laminating station adds the carrier layer to the exposed surface of the adhesive, or the layer to be contoured, the likelihood of introducing air pockets between the adhesive and the carrier layer is increased. It would be desirable to maintain the adhesive surface covered during the process.
The methods taught in Jensen '821 also include steps that add to the time required to manufacture the laminated and contoured devices. It would be further desirable to reduce the time to manufacture the laminated and contoured devices.
In addition, the laminating station may have the effect of deforming the contour achieved by the contouring station when the carrier layer is pressed to the exposed adhesive. It would be desirable to eliminate the need to apply too much pressure to the contoured adhesive surface.
The process in Jensen '821 yields substantial waste due to the removal of the protective layer prior to the addition of the backing layer. The cost of the waste is magnified when materials such as polyester are used. It would be desirable to reduce the cost of manufacturing laminated and contoured devices by eliminating the need to add and then remove a layer.
It would be further desirable to reduce the time required to carry out the process of manufacturing the laminated and contoured devices.
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Jensen Jarl B.
Jensen Robert
Mayes Curtis
McDonnell & Boehnen Hulbert & Berghoff
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