Abstract:
A ring shaped medical positioner and method for its manufacture the positioner includes a ring shaped insert wrapped in a surgical vinyl. The vinyl is divided into a first and second pieces, the first piece being formed by forming dyes engaging opposite sides of the vinyl, which is stretched between the dyes and progressively relaxed as the material is drawn into the female forming dye by the male dye and suction. The insert is placed within the formed surgical vinyl. The second piece is a flat disc which is placed over one of the surfaces of the insert and sealed to the edges of the first piece of vinyl to thereby provide a wrinkle free covering which may be easily disinfected for repeated use.

Description:
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: 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a view in perspective of a surgical positioner typical of the type manufactured by the process disclosed herein; 
     FIG. 2 is a cross sectional view taken substantially along lines  2 — 2  of FIG. 1; 
     FIG. 3 is an exploded view in perspective of a molding press and blank of surgical vinyl illustrating the manner in which one portion of the vinyl is formed into a shape for encapsulating a foam rubber ring; 
     FIG. 4 is cross sectional view of the press illustrated in FIG. 3, the press being shown with the jaws open and the vinyl blank disposed between the jaws; 
     FIG. 5 is a view similar to FIG. 4, but illustrating the platens of the press in a position in which molding of the vinyl is initiated; 
     FIG. 6 is a view similar to FIGS. 4 and 5, but illustrating the platens of the press fully closed together; 
     FIG. 7 is an exploded view in perspective illustrating the manner in which the surgical positioner is installed in another press for sealing the surgical vinyl around the foam rubber component; 
     FIG. 8 is a view similar to FIG. 7 but illustrating the components installed in the press with the platens of the press open; and 
     FIG. 9 is an enlargement of one of the corners of the positioner illustrating the manner in which the vinyl is sealed around the foam rubber and the edges of the vinyl are trimmed. 
     FIG. 10 is a perspective view of a surgical positioner for pediatric patient typical of the type manufactured by the process disclosed herein. 
     FIG. 11 is a perspective view of a head and neck surgical positioner designed for a patient in the supine position. 
     FIG. 12 is a perspective view of a slotted head and neck surgical positioner designed for the patient in the prone position. 
     FIG. 13 is a perspective view of a surgical positioner for protecting the foot and heel of a patient. 
     FIG. 13A is a rear view of the surgical positioner of FIG. 13 shown with the hook &amp; loop straps and tabs fastened. 
     FIG. 13B is a perspective view of the surgical positioner of FIG. 13 shown in a first manner of use protecting a patient&#39;s foot and ankle. 
     FIG. 13C is a perspective view of the surgical positioner of FIG. 13 shown in an alternative manner of use protecting a patient&#39;s foot and ankle. 
     FIG. 14 is a perspective view of a universal pad surgical positioner. 
     FIG. 15 is a perspective view of a surgical positioner designed to protect the ulnar nerve of a patient. 
     FIG. 16 is a perspective view of a surgical positioner designed to protect the arm or leg of a patient. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings, a surgical positioner is generally indicated by the numeral  10  and includes an annular ring or mass of polyurethane foam/foam rubber or other derformable material generally indicated by the numeral  12  which is covered by a covering or overlay of elastic surgical vinyl or other suitable material which may be treated to be bacterially resistant consisting of a contoured section  14  that is sealed against a substantially flat portion of surgical vinyl  16 . The portions  14  and  16  are sealed to each other around the outer juncture  18  between the members  14  and  16  and also around the inner juncture  20 . Accordingly, the positioner  10  includes an outer circumferential surface  22 , an inner circumferential surface  24 , an upper transverse surface  26 , and a lower transverse surface  28 . The ring of foam rubber  12  maybe formed in any manner well known to those skilled in the art. The surgical vinyl covering is a thermal formable, polyester backed commercial grade stretchable vinyl, obtainable from Uniroyal, Inc., to which common antibacterial agents have been added. 
     Referring now to FIGS. 3-6, a blank  30  of the aforementioned surgical vinyl that is to be formed into the upper contoured vinyl member  14  is clamped along its edges by movable clamps  32 , through which tension is applied to the blank  30 , thereby stretching the blank  30  to a size approximately thirty percent (30%) larger than the nominal size. The blank  30  is sufficiently large that multiple copies of the upper contour member  14  will be formed in a single blank; for example, the blank  30  as illustrated is large enough that four copies of the upper contoured member  14  are formed simultaneously. 
     The blank  30  is stretched between a male die forming member indicated by the numeral  34  which is mounted on lower platen  36  of a press generally indicated by the numeral  38 . The lower platen  36  includes a plenum  40  which is connected to a vacuum source (not shown) through vacuum hose  42 . The male die forming members  34  are circumscribed by passages  44  that communicate with the plenum  40 . Female die members  46  are mounted on upper platen  48  and are adapted to receive the male die member  34  to thereby form the blank  30  into copies of the upper contoured vinyl member  14 . 
     Accordingly, the upper platen  48  and lower platen  36  are advanced toward one another until the outer peripheral edge  50  of the lower die member is engaged by the vinyl blank  30 , as illustrated in FIG. 5, thereby forming a sealed chamber  52  between the blank  30  and the lower die members. Accordingly, suction applied through hose  42  creates a partial vacuum in the plenum  40 , thereby drawing air through passages  44  as the male and female die members are brought together. At the same time, the clamps  32  are allowed to move toward one another, thereby progressively relaxing the tension on the blank  30  as the vinyl is forced into the cavities of the dies by a combination of the movement of the male die into the female die member, and by the suction applied through the passages  44 . Since the relaxation of the vinyl blank  30  is controlled as the vinyl is forced into the mold, the vinyl can be formed without wrinkles or creases, since the suction applied also assures that the blank is properly drawn around the die members. As discussed above, the vinyl blank  30  is a thermal formed vinyl, so that the dies  34  and  46  are heated, thereby permanently forming the vinyl into the shape of the upper contoured vinyl member  14 . 
     After the upper contoured vinyl members  14  are formed, the press is opened, the formed blank  30  is removed from the press, and the copies of the contoured member  14  are cut from the blank  30 , to provide an untrimmed contour member as indicated at  54  in FIG.  7 . Forming rings  56 ,  58  are provided in a lower platen  60  of another press generally indicated by the numeral  61 . The forming rings  56 ,  58  define an annular volume  62  then accepts the contoured portion  64  of the untrimmed formed vinyl member  54 . After the contoured portion  64  is installed in volume  62 , the deformable ring  12  is placed in the contoured portion  64 . Unformed sheet  66  is then laid over the untrimmed vinyl blank  54  and deformable ring  12 , as clearly shown in FIG.  8 . In the preferred embodiment the same stretchable material was utilized for sheet  66 ; however, as the second sheet does not necessarily have to be stretched, a different material may be used. The upper platen  68  and lower platen  60  are then advanced toward one another, until the upper platen  68  engages the untrimmed vinyl  66 . The upper platen  68  is provided with heating elements  70  (FIG.  9 ), which heat the vinyl and cause the edge portions  18  to fuse together because of heating and transonic energy applied through the upper platen  68 . The upper edges of the rings  56  and  58  are provided with a knife edge  72  which trims off the excess  74  of the untrimmed member  54  and sheet  66 . The finished product can then be removed from between the rings  56  and  58 . 
     Alternate embodiments of surgical positioners embodying the inventive concept disclosed herein are illustrated in FIGS. 10-16. These embodiments are manufactured by the same process or method described for making the ring of FIG.  1 . FIG. 10 shows a medical positioner generally indicated as  80  which is similar to surgical positioner  10 , but is designed to protect the head of a pediatric patient and is therefore smaller. Pediatric positioner  80  includes an outer circumferential surface  82  and an inner circumferential surface  84  defining a central opening  85 . Pediatric positioner  80  has the general shape of a ring and includes an upper transverse surface  86  and a lower transverse surface  88 . Central opening  85  is designed to accommodate the back of a head of a pediatric patient lying in the supine position. 
     An alternate embodiment head and neck positioner generally indicated as  90  is shown in FIG.  11 . Postioner  90  includes an outer surface  92  which may be, for example, either generally square, rectangular or cylindrical and an inner circumferential surface  94  which defines a generally central opening  95 . Head and neck positioner  90  also includes an upper surface  96  and a lower transverse surface  98 . Head positioner  90  further includes a neck support contour  99  for supporting the neck of a patient lying in the supine position with the back of the patient&#39;s head aligned in the central opening  95 . 
     A prone head support positioner is shown generally as  100  in FIG. 12 for supporting the head of a patient lying in a prone or face down position. Prone positioner  100  includes an outer surface  102  and an inner surface  104  defining a generally central opening or slot  105 . Outer surface  102  is shown as being generally square, but as with all positioner embodiments, may be changed to any desired shape such as circular, rectangular or elliptical. In the preferred embodiment of prone positioner  100 , central opening  105  has a shape similar to that of a bicycle seat having a wider portion  105   a  and a more narrow portion  105   b . The positioner is designed so that the patient&#39;s forehead would coincide with wider portion  105   a , and the patient&#39;s chin area would coincide with the more narrow portion  105   b . Prone head positioner  100  also includes an upper surface  106  preferably having a concaved profile to more readily conform to the patient&#39;s face and a flat lower transverse surface  108 . 
     Now referring to FIGS. 13, and  13 A-C, a foot and heel positioner is generally indicated as  110 . In the preferred embodiment, the foot and heel positioner has a generally rectangular shape having an outer surface  112  and an upper surface  114  defining a multiplicity of grooves  115  running generally parallel to one another and transverse to the length of foot and heel positioner  110 . Positioner  110  also includes a lower transverse surface  116 . Along one side of positioner  110  is a pair of tabs  117   a ,  117   b . As shown in FIG. 13, tab  117   a  has either hook or loop material attached to the bottom side thereof while tab  117   b  has the mating hook or loop material  118   b  to mate and fasten to material  118   a . Tabs  117   a ,  117   b  are preferably an extension of the covering material wrapped about the cushioning material within positioner  110 . The hook and loop material  118   a ,  118   b  are preferably attached to respective tabs  117   a ,  117   b  using adhesive or stitching. On the side of positioner  110  opposite tabs  117   a ,  117   b  and preferably at the corners of the positioner are a hook and loop strap  119  and a mating hook or loop tab  120 . As with tabs  117   a ,  117   b , one of either strap  119  and tab  120  carries a hook material while the other carries the mating loop material so that strap  119  may be fastened to tab  120 . 
     The purpose of the grooves  115  is to increase the bending flexibility of positioner  110  so as to be able to bend the positioner to conform around the foot and heel of a patient as shown in FIGS. 13A-C. In FIG. 13A, the foot and heel positioner is illustrated from an end view as bent about grooves  115  and secured by the hook and loop material on tabs  117   a ,  117   b  as well as strap  119  and tab  120 . The foot and heel positioner is depicted in FIGS. 13B and 13C showing two different manners of securing the positioner about a foot  122 . In FIG. 13B, positioner  110  is wrapped around the heel and ankle of the patient. Strap  119  is placed about the upper portion of a patient&#39;s ankle while tabs  117   a ,  117   b  are fastened and located adjacent the bottom rear portion of foot  122 . In FIG. 13C, positioner  110  is shown wrapped about the bottom and side portions of foot  122 . Strap  119  is placed over the top front portion of the foot while tabs  117   a ,  117   b  are fastened behind the heel portion  124  of the patient&#39;s foot and secured to one another with the hook and loop material. 
     A universal pad medical positioner generally indicated as  130  is shown in FIG.  14 . In the preferred embodiment, the universal pad has a generally rectangular shape defined by outer surface  132 . Universal pad positioner  130  also includes an upper surface  134 , defining generally parallel transverse grooves  135 , and a lower transverse surface  136 . Universal pad positioner  130  can be placed anywhere beneath the patient where it is desire to provide a cushioning effect such as beneath the shoulders, back, buttocks or chest of the patient. As with foot and heel positioner  110 , grooves  135  in universal pad positioner  130  provide increased flexibility and cushioning of the pad. 
     In FIG. 15, an ulnar nerve protector medical positioner is generally indicated as  140  which has a generally elliptical shape defined by outer surface  142 . Ulnar protector positioner  140  also includes an upper surface  144 , which defines transversly extending and generally parallel grooves  145 , and a lower transverse surface  146 . A hook or loop strap  147  is attached at one end of ulnar protector positioner  140  and at the opposite end  148  of the positioner, the mating hook or loop material to strap  147  is attached to bottom surface  146 . Of course, a tab similar to  120  may also be attached to end  148  and the hook or loop material affixed thereto. As with foot and heel positioner  11 , grooves  145  increase the flexibility and allow ulnar protector positioner  140  to be srapped about the elbow and forearm of a patient. The positioner can then be secured by fastening strap  147  to the hook or loop material at end  148 . 
     In FIG. 16, an arm or leg pad positioner is generally indicated as  150 . Positioner  150  is similar to ulnar protector positioner  140  except that it does not have an attached strap or hook and loop material. Positioner  150  has a generally elliptical shape defined by an outer surface  152  and an upper surface  154  defining transverse generally parallel grooves  155 . A lower transverse surface is designated as  156 . 
     While the invention has been taught with specific reference to the above embodiments and some variations have been suggested above, one skilled in the art will recognize that other changes can be made in form and detail without departing from the spirit and scope of the invention. For example, instead of the hook and loop fasteners that are shown attached to some of the embodiments, separate, disposable hook and loop straps and/or fasteners may be used to wrap around any of the positioners for securing the same about the body part of the patient. It would also be possible to substitute the hook and loop fasteners with straps and buckles, snaps or any other well known fastening means. One could also replace the openings shown in the various embodiments of head positioners with a partial opening or recessed area. The shape of the area contoured to support the head may also be varied. Furthermore, the shape, spacing, or orientation of the transverse grooves may be varied as desired. Also, the universal pad positioner  130  or any of the other pads may be molded to more comfortably assume a particular body part shape such as shoulders, chest or buttocks. As such, the described embodiments are to be considered in all respects as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the independent claims rather than by the description.