Medical positioner and method for its manufacture

Beds – Support for users body or part thereof – With substantial foam component

Reexamination Certificate

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Details

C005S621000, C005S630000, C005S636000, C005S737000, C128S845000

Reexamination Certificate

active

06625831

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a reusable surgical positioner for supporting body members during surgery, and to a process encasing a polyurethane insert in medical grade vinyl by thermal vacuum forming the vinyl, installing the insert in the vinyl, and sealing the vinyl around the insert to provide a product for reusable use in various health care venues such as surgery.
2. Discussion of the Prior Art
Surgical positioners are used to position, support and prevent injury to the human body for patients undergoing surgery. These positioners are commonly made out of polyurethane foam, and are discarded after use. For example, donut shaped positioners are used to position the head of a patient during surgery in some procedures, and then discarded.
SUMMARY OF THE INVENTION
Such positioners are discarded because it is impossible to insure that the positioner is properly cleaned after use. In order to insure a clean and sterile environment, the foam positioner must be encapsulated in a surgical vinyl, which may be cleaned and disinfected for reuse. Of course, the vinyl cannot be sewn or otherwise attached by processes that punch holes in the vinyl because holes provide areas where bacteria may be lodged and where it is difficult or impossible to clean and disinfect. Prior art positioners using gel filled surgical vinyl are available, but these have proven to be unsatisfactory because the gel conducts heat. Since operating rooms are maintained at a relatively low temperature (usually about 62° F.), the gel filled positioners remain at this temperature, thus draining heat from the patient and retarding circulation in that portion of the body where the positioner is used. Polyurethane foam has heretofore not been covered with surgical vinyl because of difficulties in applying the vinyl to the polyurethane foam in a manner such that wrinkles, creases, etc. in the vinyl covering polyurethane foam, which may harbor harmful bacteria, are eliminated. The present invention relates to a surgical positioner and a method for its manufacture, in which surgical vinyl encapsulates a deformable material such as polyurethane foam or foam rubber in a manner in which creases, wrinkles, etc. are eliminated and heat sealing is used to provide a seam that is resistant or impenetrable to bacteria and so that sewing, and the resulting needle holes, are eliminated. Accordingly, the positioner can be used repeatedly and disinfected after each use in the same manner in which other operating room appliances are disinfected, that is, by wiping with a cleaning pad which has been dipped in disinfectant.
These and other advantages of the present invention will become apparent from the following description with reference to the accompanying drawings in which:


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