Abstract:
A bag member for receiving used surgical sponges in a surgical sponge storing system, composed of a first sheet of flexible material forming a main bag having a periphery, and a plurality of second bag members mounted to the first sheet and forming sponge holding bags. A surgical sponge storage and counting system for use in a surgical operating room, composed of: a pail; a stand mounted on wheels for permitting the stand to be rolled across an operating room floor; a pail supporting member for supporting the pail; a unit for mounting the pail supporting member on the stand and for adjusting the height of the pail above the floor; and a bag member receivable in the pail for containing and storing used surgical sponges.

Description:
This application is a continuation in part of patent application Ser. No. 08/404,285 filed Mar. 14, 1995 now U.S. Pat. No. 5,658,077, which is a continuation in part of patent application Ser. No. 08/204,674, filed Mar. 2, 1994, abandoned. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to the disposal of surgical sponges. 
     Surgical procedures frequently involve the use of sponges, sometimes referred to as swabs, to absorb blood and other body fluids at the operating field, for example to permit unobstructed viewing of the region being operated upon. Before completion of the surgical procedure, all of the sponges which have been introduced into the patient&#39;s body must have been removed. This requires that personnel in the operating room keep track of the number of sponges which have been placed in the patient&#39;s body, and the number of sponges subsequently removed therefrom. 
     Standard procedures which have been developed for this purpose include those in which used sponges which have been removed from the patient&#39;s body during surgery are counted in groups of a given number, typically five or ten sponges to a group, each counted group is placed in a container, such as a plastic bag, and before the surgical procedure has been completed, typically by suturing the incisions made during surgery, all groups of used sponges are counted to verify that all sponges which have been used are accounted for. 
     After a sponge has been withdrawn from the patient, it is common practice to drop or throw the sponge into a bucket, known in the art as a kick bucket, which rests on the floor at a location selected so as not to interfere with the surgical procedure. A kick bucket is typically a bucket mounted on wheels to be easily moved across the operating room floor. Buckets of this type are marketed by various companies, including Vollrath Group Inc., Gallaway, Tenn. 38036 and Blickman Health Industries, Inc., Fairlawn, N.J. 07410. 
     At various times during an operation, sponges will be transferred from the bucket to a storage and disposal unit constructed to permit a count of used sponges to be maintained. 
     One commercially available disposal system consists simply of a set of clear plastic bags each of which is intended to store five sponges of one type, such as laparotomy sponges, or ten sponges of another type, such as raytex sponges. After the given number of sponges has been placed in the bag, it is closed. The bag is transparent, so that the sponges remain visible for observation by attending physicians. Bags of this type are distributed, for example, by Sage Products Inc. of Crystal Lake, Ill. 60014. 
     Another commercially available system is composed of a clear plastic component provided with a plurality of pockets. Either five or ten sponges, depending on the type, can be counted into each pocket. Here again, the sponges remain visible and, at the completion of surgery, the number of pockets which have been filled with sponges can be counted to produce a sponge count. Products of this type are marketed by, for example, Kendall Healthcare Products Company, under the trade name Curity”, as well as by the above-identified Sage Products Inc. 
     The known systems described above have a number of drawbacks. For example, because available kick buckets generally rest on the floor, it is not possible for the operating room personnel to reliably drop or toss the sponges into the kick bucket. As a result, it frequently occurs that a certain number of used sponges, contaminated with blood, will be dropped onto the operating room floor, splashing blood-borne pathogens on the operating room floor, and must then be picked up by operating room personnel. 
     Then, the kick bucket must be displaced to the location where they are to be counted into bags or pockets and the person collecting the sponges must repeatedly bend over to pick up the sponges. 
     Thus, overall, the sponges must be subjected to a considerable amount of handling after use, with the risk of contamination of operating room personnel increasing with the amount of handling required. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a bag member for receiving used surgical sponges and a surgical sponge storage and counting system employing such bag members which eliminate or minimize the drawbacks encountered in the prior art. 
     A more specific object of the invention is to reduce the number of handling procedures required to transfer a used sponge from the patient to a location for final counting, containment and disposal. 
     Another object of the invention is to reduce the number of occasions on which a sponge will be dropped on the floor or blood from the sponge will drip on the floor of the operating room. 
     Another object of the invention is to reduce the physical demands imposed on operating room personnel in connection with disposal of used sponges. 
     Yet another specific object of the invention is to facilitate the transfer of used sponges to individual counting bags, or pockets, followed by sealing of the bags for final disposal. 
     The above and other objects are achieved, according to the present invention, by a bag member for receiving used surgical sponges in a surgical sponge storing system, comprising: a first sheet of flexible material forming a main bag having a periphery, and a plurality of second bag members mounted to the first sheet and forming sponge holding bags. 
     The objects according to the invention are further achieved by a surgical sponge storage and counting system for use in a surgical operating room, comprising: a pail; a stand mounted on wheels for permitting the stand to be rolled across an operating room floor; a pail supporting member for supporting the pail; means for mounting the pail supporting member on the stand and for adjusting the height of the pail above the floor; and a bag member as described above, receivable in the pail for containing and storing used surgical sponges. 
     In order to aid in the understanding of this invention, it can be stated in essentially summary form that it is directed to a sponge counting bag which is formed of front and back sheets of substantially transparent synthetic polymer composition material. The front and back sheets are closed at the bottom and side edges. The back sheet extends upward, and the front sheet is folded down at its top edge to form a cuff. The cuff is wrinkled on its free edge to permit easy opening of the bag. The sponge counting bag may have a reopenable, fold-down flap or may have a plurality of such bags arranged one above the other. 
     It is thus a purpose and advantage of this invention to provide a sponge counting bag which is easy to open so that sponges can be readily placed therein at the end of a surgical procedure so that they may be readily counted. 
     It is a further object and advantage of this invention to provide a sponge counting bag which facilitates placement of the sponges in the counting bag for subsequent counting by having a cuff thereon which is readily grasped or single-finger manipulated to pull the bag open. 
     It is a further purpose and advantage of this invention to provide a flap on the sponge counting bag which can releaseably close the bag. 
     The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages thereof, may be best understood by reference to the following description, taken in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1A is a perspective, partly exploded, view of an embodiment of a surgical sponge hold apparatus according to the invention. 
     FIG. 1B is an elevational view of one of the components of the apparatus shown in FIG.  1 A. 
     FIG. 1C is, an elevational, cross-sectional view showing portions of the apparatus of FIG. 1A associated with a bag member according to the invention and an additional plastic liner. 
     FIG. 1D is a plan view of the bag member shown in FIG.  1 C. 
     FIG. 1 is an isometric view of the first preferred embodiment of the sponge counting bag of this invention. 
     FIG. 2 is an enlarged section taken generally along line  2 — 2  of FIG.  5 . 
     FIG. 3 is an enlarged section of a portion of the bag shown in FIG. 2 showing the easy manipulation of the wrinkled edge. 
     FIG. 4 is a section similar to FIG. 2 showing the bag filled with sponges and showing its flap closed. 
     FIG. 5 is an isometric view of the second preferred embodiment of the sponge counting bag this invention, with parts broken away. 
     FIG. 6 is an enlarged section taken generally along the line  6 — 6  of FIG. 5, with parts broken away. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1A shows one embodiment of apparatus according to the invention which can be employed for initial collection of used surgical sponges during the course of a surgical procedure. This apparatus includes a stand  102  composed of a base  104  whose legs are provided-with casters  106  and an upright  108  extending vertically from base  104 . Upright  108  preferably is a hollow tubular member. 
     Mounted above base  104  is a catch basin  110  provided at the center of its bottom nut  112  for receiving a threaded rod  114 . Rod  114  extends into tubular upright  108  and is engaged by a locking, or latching, member  116  which is constructed to be manually operable in order to allow rod  114 , and thus basin  110 , to be moved vertically to a desired height above the operating room floor. When basin  110  is at the desired height, locking member  116  is released to automatically hold rod  114  in place with respect to upright  108 . Locking member  116  can be of any known type which locks cooperating members in position when released. 
     The top surface of basin  110  carries a pail supporting member  120  composed of a plurality of flat bands  126  bent to have substantially an L shape with a short horizontal leg and a long upright leg, and a ring  128 . The short legs of bands  126  are welded to basin  110  and the tops of the long legs of bands  126  are welded to ring  128 . The components of supporting member  120  are shaped to provide a conforming receptacle for a pail  130 . 
     Nut  112  may be welded to basin  110  and rod  114  is secured into nut  112 . Thus, rod  114  is easily removable from basin  110  for cleaning. 
     With the apparatus illustrated in FIGS. 1A and 1B, the height of bucket  130  above the floor of the operating room can be readily adjusted over a given range to a height which is most convenient for the operating room personnel responsible for transferring used sponges to, and subsequently removing used sponges from, bucket  130 . At the same time, the advantages of conventional kick buckets, i.e. their ability to be easily rolled to any desired location in the operating room, is maintained. 
     If, during use, it should be found that bucket  130  has not been placed at the most convenient height, its height can be readily adjusted by actuating locking member  116 , manually raising basin  110  or supporting member  120  and releasing locking member  116  when pail  130  is at the desired height. 
     The height adjustable kick bucket illustrated in FIGS. 1A and 1B can be employed in accordance with conventional practice in the art, i.e. used sponges can be dropped or placed in a liner in pail  130 , and the sponges can then be counted for subsequent disposal. 
     However, according to a further feature of the invention, the system shown in FIG. 1A may be supplemented by a novel plastic bag member according to the invention, as shown in FIGS. 1C and 1D. FIG. 1C illustrates pail supporting member  120  and pail  130  of the device shown in FIGS. 1A and 1B. As illustrated in FIG. 1C, there may be provided, between pail supporting member  120  and pail  130 , a lining sheet  140  made of any suitable nonporous plastic material which will overlie, and act as a liner for, the interior of basin  110 . Then, pail  130  is placed in supporting member  120  with sheet  140  interposed therebetween. 
     According to the invention, bag member  150  is constituted by a sheet  152  of nonporous plastic material, which may be any material acceptable for storage and disposal of infectious waste, such as used surgical sponges. Sheet  152  is configured to have the form of a bag with a periphery, or outer edge,  154 . Thus, sheet  152  can be installed to serve as a liner for the interior of pail  130 . 
     In further accordance with this aspect of the invention, sheet  152  carries a plurality of sponge holding bags  156  each having an open end  158  for receiving used sponges. The side of each bag  156  which is remote from sheet  152  is given a sufficient length to provide a flap  160  which can be gripped at a safe distance from the bag opening provides a guide surface for safely directing sponges into the bag and can be folded into the associated open end  158  in order to loosely close the associated bag  156 . 
     Each bag  156  may be bonded, as by cementing or heat sealing, to sheet  152 , for example along a line  162  adjacent the associated open end  158 . 
     It will be noted that in the embodiment illustrated in FIGS. 1C and 1D, sponge holding bags  156  are oriented such that their open ends  158  face away from edge  154  of sheet  152  and toward the interior, or center, of the bag formed by sheet  152 . With this orientation, as is apparent from a consideration of FIGS. 1C and 1D, when bag member  150  is inserted into pail  30 , the peripheral portion of bag member  150 , or sheet  152 , is draped over the edge of pail  130  so that the open ends  158  of sponge holding bags  156  are oriented upwardly, in the normal position for receiving items. 
     Thus, in the use of bag member  150 , during the course of an operation, used sponges will be placed in the portion of bag member  150  which lines the interior of pail  130 . At any time during the surgical procedure, when a sufficient number of used sponges have accumulated, the sponges can be counted into sponge holding bags  156  and after the predetermined number of sponges has been counted into a bag  156 , flap  160  may be folded over into opening  158  so as to enclose the sponges therein and thus loosely close the associated bag. 
     The opposing faces of each bag  156  are sealed together along a sealing line (not visible) which extends over a portion of the height of the bag from the bottom thereof to divide the interior of bag  156  into two halves. The manner in which this sealing line is employed will be described in detail below. 
     In accordance with the usual practice in this art, each bag  156  may be employed to receive five sponges of one type, such as laparotomy sponges, or ten sponges of a second type, such as raytex, sponges. In the former case, the operating room personnel may break the dividing seal in the associated bag  156 , simply by pressing down on the seal with the first sponge introduced or with the hand before introducing the first sponge. In the case when ten sponges are to be stored in a bag  156 , the dividing seal is left intact and five sponges are placed to each side of the dividing seal. 
     If the sponges being disposed of are the type equipped with string tabs, a portion of the string tab of each sponge may be allowed to hang outside the associated bag  156  when sponges are initially counted and introduced therein. Then, each string tab may be placed fully within the associated bag  156  at the time of a subsequent sponge count. After the appropriate number of sponges has been counted into a bag  156 , and flap  160  has also been folded into bag  156 , the number and type of sponges therein can be written on the bag with a suitable marker. 
     After all four bags  156  have been filled with the requisite number of sponges, and the count has been verified by any approved procedure, edge  154  of sheet  152  can be lifted in order to bring bags  156  to the interior of bag member  150 . As this is being done, bags  156  will roll or flip over toward the interior and bottom of bag member  150 . Then, to complete the sealing process, the edge of sheet  152  may be torn away along a perforation  166 , providing a thin strip of plastic which can be used to tie the open end of bag member  150  closed. Bag member  150  is thin ready for final disposal. 
     The system according to the invention offers the further advantage of reducing the risks associated with airborne and blood borne pathogens because contaminated sponges are never removed from the apparatus until final disposal. 
     All of the parts of bag member  150  are preferably made of a material or materials which are nonpermeable, transparent and safely incinerable. 
     While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. 
     Specific Embodiment of Sponge Counting Bags 
     The first preferred embodiment of the sponge counting bag of this invention is generally indicated at  10  in FIGS. 1,  2  and  4 . The bag  10  is made of substantially transparent flexible synthetic polymer composition sheet material such as polyethylene. The bag has a front layer  12  and a back layer  14 . These layers are attached together along bottom edge  16  and left and right edges  18  and  20  to create a bag having an opening  22  at its top. The back layer extends upward above the bag opening to form closure flap  24 . The closure flap has a height almost as tall as the bag from its bottom edge to its opening so that the closure flap can be pulled down over the front for substantial overlap over the bag opening. 
     A line of pressure sensitive adhesive  26  is provided on the front of the flap  24 . The line of adhesive is covered by protective release strip  28 . The release strip  28  covers the adhesive  26  until adhesive closure of the bag is desired, whereupon the release strip is removed. It is shown half pulled off in FIG.  5 . After it is removed, the flap is pulled down over the front of the bag and is attached closed by means of the pressure sensitive adhesive, as seen in FIG.  4 . The adhesive is of such nature as to be sufficiently aggressive to securely hold down the closure flap to hold the bag closed under ordinary circumstances. However, the aggressiveness of the adhesive is sufficiently limited so that, if it is required that the bag be reopened, such can be accomplished without tearing the bag. After closure, if the closure flap is lifted, the bag can be opened without tearing. 
     Another important feature of the bag  10  is the folding down of the upper edge of the front layer to form folded-down flap or cuff  30 . The cuff  30  is stretched along its lower edge  32  to form wrinkles  34 . The wrinkles can be achieved by any convenient means such as by hot corrugated rollers or by direct application of heat, such as infrared or laser application. In this latter case of the application of heat, the polymer material is such that, when heat is applied, wrinkling occurs. Since there are wrinkles adjacent the lower edge of the cuff, this lower edge cannot lie directly flat against the front layer  12 . As a consequence, a finger  36  can readily engage under the cuff  30  to pull open the opening  22  seen in FIG.  3 . The wrinkling prevents the inconvenience and delay which sometimes occurs when two polymer layers must be separated. 
     The sponge counting bag  10  has a tack seal  38  between its front and back layers, see FIGS. 1 and 2. This tack seal is substantially midway between the left and right edges  18  and  20 . The tack seal is about one-third the way up the bag  10  between its bottom edge  16  and opening  22 . The tack seal is not a very localized one, but may be a ring to spread the sealing. The tack seal is configured so that it holds the front and back together moderately well but, when a larger bag volume is required, the tack seal can be pulled apart without making an opening in the front or back layers of the bag. 
     When the sponge counting bag  10  is in use, it is held up by the top edge of the closure flap  24  in the open position shown in FIGS. 1 and 2. When the sponges are small, the tack seal  38  is left attached. Five small sponges can be placed in an upright column on each side of the tack seal. Thus, the tack seal holds the columns of sponges in line for recounting even after the bag is closed. However, when the sponges are larger, larger bag volume is required so that the tack seal is pulled apart. 
     Sponges  40  are placed in the bag to a determined count until the bag is full, as seen in FIG.  4 . When full, the release strip  28  is removed and the closure flap is pulled down and sealed. If a recount is necessary, just prior to closing of the operating incision by the surgeon, the sponges in the bag can be counted through the transparency thereof, or if there are several layers, the bag can be reopened by pulling open the flap so that the individual sponges can be separated, counted and replaced into the bag. This permits easy recounting and easy resealing. 
     A second preferred embodiment of the sponge counting bag of this invention is shown in FIGS. 5 and 6 where it is generally indicated at  50 . The sponge counting bag  50  comprises a plurality of attached bags arranged one above the other. The sponge counting bag  50  comprises a back layer  52  of flexible substantially transparent, thermoplastic synthetic polymer composition material, such as polyethylene. In the original manufacture of the sponge counting bag  50 , the back layer is folded up all the way to the back top edge  54 . The bottom fold  56  closes the bottom of the lowermost sponge bag  58  of the upright string of sponge counting bags. The folding up of the back layer provides front layer  60 , front layer  62 , and front layer  64 , respectively, of the lower sponge bag  58 , the intermediate sponge bag  56  and the upper sponge bag  68 . The three sponge bags illustrated are sealed at their left and right edges  70  and  72  by heat sealing. In addition, the lower closure of the intermediate and upper sponge bags  66  and  68  are formed by heat-sealing along heat seal bottom edge lines  74  and  76 . The openings of the lower and intermediate bags  58  and  66  are created by slitting the front layer at slit lines  78  and  80 . This creates flaps or cuffs  82  and  84 . These cuffs are folded down, as shown. They may have to be separated at their edges for proper folding. The top edge of the front sheet is also folded down at the upper sponge bag to create flap or cuff  86 . It may be necessary to reheat-seal the edges of these cuffs in order to hold them down, as shown. The cuffs are wrinkled along their lower, free edge. Wrinkles  88 ,  90  and  92  are shown. These wrinkles permit easy opening of each of the bags, as desired. The entire bag system  50  is retained in place by hanging it from convenient hooks which engage in support holes  94  and  96 . The set of bags  50  also has tack seals,  98 ,  100  and  102  for the same purpose as the tack seal  38 . 
     The system of sponge counting bags  50  is used in much the same manner as the use of the sponge counting bag  10 . The system of bags  50  is supported from suitable hooks engaging in its support holes near the top edge. Each of the individual bags is then positioned for accessibility. When a used sponge is received, the nurse places it in one of the bags. This is accomplished by slipping a finger under the wrinkled edge which opens that bag without difficulty. This provides ease and speed of operation. The sponges in the bags are visible so that they may be counted at the end of the surgical procedure. 
     Specific Embodiment of the Sponge Counting Bag System with a Pail System The sponge counting bag embodiment just described for FIG. 1 is preferably used as attachable by adhesive means described therefor to the sheet  52  of FIG. 1C for example, along line  62  adjacent to the associated open end  58 . Another embodiment of the present invention is shown in FIG. 1A whereby the multiple bag system described for FIGS. 5 and 6 is effectively draped from an extension of the pail support pole such that the lowest edge of the sponge counting bag system is held substantially above the rim of the pail  130  of FIG.  1 A. This arrangement eliminates the need for the sponge counting bags preferably adhered to sheet  152  of FIG. 1C since the sponge counting function is achieved with a vertically accessible sponge counting bag system. 
     FIG. 1A further shows sponge counting bag pole support  200  which supports lower pole  201 , height/rotation adjustment  202 , and upper pole  204  such that sponge counting bag  50  hangs vertically above or just outside of the horizontal upper edge of pail  130 . It is seen that sponges  209  may be deposited in sponge counting bag  50  by drawing open a bag section at flap  86 . Sponge counting bag  50  is hung from holes  96  on hooks  205  which extend from wire frame  207 . Wire frame  207  is supportively attached along horizontal extension  206  of upper pole  204 . Wire frame  207  also may support documents related to sponge counting according the SpongTrak™ system. 
     Thus, according to this embodiment, routine deposition of used sponges may be made to a lined pail  130  during surgical procedures and the easily visible sponge counting bag  50  displays the results of subsequent counting and deposit of the sponges in pail  130  to the separate sections of sponge counting bag  130 . This development provides at a glance from operating room personnel, even if located relatively far from the sponge counting bag  50 , a quick visual check of the blood volume removed from a patient during surgery in the sponges. Since each of the bag sections of sponge counting bag  50  will contain a pre-determined number of sponges, i.e. five to 10, visual inspection of the number of sealed bag sections will quickly indicate by simple multiplication the approximate total number of sponges used and the degree of body fluid saturation in each one. It is a further advantage that the series of bag sections in sponge counting bag  50  provides a visual history of the progress of bodily fluid removal during the surgical procedure.