Abstract:
The invention relates to a multipurpose device for the safe handling of sharp surgical implements and comprises a molded thermoplastic body that includes a container portion and a scalpel holder section. Magnetic material in the container holds scalpel blades and/or needles after use and magnetic material on the holder section presents a needle for pick-up by a needle holder. The scalpel holder section supports a scalpel or scalpels in cantilever fashion for convenient gripping and withdrawal by a surgeon. The body has a shape and surface characteristics that assures a secure hand grip even in wet conditions.

Description:
This application is a continuation of application Ser. No. 10/634,072, filed Aug. 4, 2003 now U.S. Pat. No. 7,036,661, which application is a continuation-in-part of application Ser. No. 09/847,969, filed May 2, 2001 now abandoned, which application claims the priority of U.S. Provisional Application No. 60/203,363, filed May 10, 2000. 
    
    
     TECHNICAL FIELD 
     The invention relates to an improved design for a container which is a health care safety product designed to help protect against accidental injury during the passage of sharp instruments; i.e., suture needles and scalpels within the performance of any surgical procedure. It does not involve direct patient contact. 
     BACKGROUND OF THE INVENTION 
     There are approximately 500,000 to 800,000 needle stick injuries reported each year regarding healthcare professionals in the United States. Other than in the patient&#39;s room, these accidents occur most often in the operating room. As a result of this significant health hazard, health device manufacturers have developed various products designed to protect healthcare professionals. These items include retractable syringes, “sharps” containers, syringe covers, syringe guards, etc. While needle sticks associated with syringes account for an estimated 75% of the problem, it is estimated that most of the remaining 25% are the result of sticks associated with suturing during surgical procedures or during the unprotected passing of these sharps. It is this niche which has not been adequately adressed by suture manufacturers who have left it up to the discretion of the end user to provide their own protection. 
     The Occupational Safety &amp; Health Administration (OSHA) in directive #CPL2-2.44D, issued Nov. 5, 1999 mandated a change in the Federal Blood Borne Pathogens Act. They called for a shift in work practice controls and issued a call for engineering solutions for use when sharps are passed from one individual to another. The Act states, “The employer must use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent.” Further, they specifically called for the elimination of “hand-to-hand” or direct passing of all sharps. The overall goal is to reduce the risk of accidental needle or scalpel injuries during this process. 
     Additionally, they issued four engineering design requirements which include: 
     (1) A thick safety feature that provides a barrier between the hands and needle after use. The safety feature should allow or require the worker&#39;s hands to remain behind the needle at all times; 
     (2) The safety feature is an integral part of the device and not an accessory; 
     (3) The safety feature is in effect before disassembly and remains in effect after disposal to protect users and trash handlers; and 
     (4) The safety feature is as simple as possible, requiring little or no training to use effectively. 
     The apparatus of the present invention is designed to meet all of OSHA&#39;s design requirements while remaining user friendly and without the incorporation of new hand movements during an operation. It is compact, hand-held, and functions for both suture needles of all sizes as well as scalpels. Additionally, it functions as a safe return device (i.e., passing of sharps occurs in two directions). Moreover, it acts as a counting device for needles and also functions as a temporary storage and/or disposable container for used suture needles and scalpels. Known efforts to date have been focused on prevention of syringe needle sticks with retractable syringes. Simple guard type devices are also available for some scalpels. No other multi-functional yet simple device for use with suture needles and scalpels that also satisfies the new OSHA requirements is known. 
     The Prior Art fails to recognize the value in coupling slots for use with sharp implements which effectively immobilize the sharp implement for transfer purposes, coupled with a magnetically enhanced disposal compartment for easy counting and disposal. By using the novel design of the present invention, coupled with the new system arrangement of the essential elements of the invention, a more flexible configuration is shown which overcomes the inherent limitations of the teachings of the Prior Art as well as permitting a wider range of applications, not permitted with the presently available systems. 
     SUMMARY OF THE INVENTION 
     The invention eliminates many of the inherent limitations of the Prior Art by designing an apparatus which, in one embodiment, is composed of a rectangular box of clear plastic with approximately half of the box top open. Magnets are embedded within to secure the needle mounted in a special slot. A sliding door on the top half holds sharps (i.e. used suture needles and scalpel blades). The scalpel anchors are similarly embedded and designed to cover the scalpel itself while exposing only the handle. In this preferred embodiment, it is designed for single use, although reusable versions are contemplated. 
     It is an object of this invention to provide an apparatus which is designed to meet all of OSHA&#39;s new regulations, be hand-held and compact, with dual functions for both suture needles as well as scalpels. 
     These and other objects of this invention will be evident when viewed in light of the drawings, detailed description, and appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may take physical form in certain parts and arrangements of parts, a preferred embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof, and wherein: 
         FIG. 1  is a top view of the apparatus comprising this invention showing a sliding door in a partially open position; 
         FIG. 2  is a side elevational view of the apparatus shown in  FIG. 1 ; 
         FIG. 3  is a cross-sectional view as may be taken at the line  3 - 3  in FIG;  2 ; 
         FIG. 4  is a top view of the sliding door; 
         FIG. 5  is an enlarged cross-sectional view of the door shown in  FIG. 4  as taken at the line  5 - 5  thereof; 
         FIG. 6  is a cross-sectional view taken at the line  6 - 6  in  FIG. 2  and showing an alternative configuration for a wall which divides the two compartments of the apparatus; 
         FIG. 7  is a perspective view of the main body of a second version of a sharp instrument handling device shown with its cover open; 
         FIG. 8  is a perspective view of a bottom side of the device of  FIG. 7 ; 
         FIG. 9  is a plan view of the device of  FIG. 7  shown with the cover open and with a magnetic sheet including a counting grid within a closable container portion of the body and a magnetic sheet on a forward or proximal end of the device; 
         FIG. 10  is a side elevational view of the device of  FIG. 7 ; 
         FIG. 11  is a perspective view of the device of  FIG. 7  in a hand-held orientation and carrying a scalpel for presentation to a surgeon; and 
         FIG. 12  is a perspective view of the bottom side of the device carrying a suture pack. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings wherein the showings are for purposes of illustrating the preferred embodiment of the invention only and not for purposes of limiting the same, the Figures show the apparatus for sharp implement transfer, counting and temporary disposal or storage of the present invention. 
     This device is hand-held and at least partially constructed of clear plastic with embedded magnets. The chosen material of construction must be capable of withstanding a sterilization environment, although in one embodiment, it will only be used once. Traditionally, suture needles, scalpels and other sharps are passed “hand-to-hand” or directly from assistant to surgeon. As an example, in the course of an operation, the passing of sharps occurs in the following steps. The assistant removes the needle from the sterile package and mounts the needle on a needle holder. The needle is exposed. The assistant then “passes” the needle and holder to the surgeon using direct, hand-to-hand technique. The surgeon, when completed, then passes the needle back to the assistant. Again, the needle/scalpel remains exposed at all times during this process. 
     The needle escort provides protection during each step of the above procedures. First, the assistant uses a needle holder to mount the needle within the protective escort device. Secondly, the needle escort device is passed with the hands behind the needle, as specified in OSHA requirements. The only way for the surgeon to access the needle is with a needle holder, not with the use of hands or fingers. When complete, the surgeon disposes the needle in the top retractably sealable box where the used needle remains until the end of the case, at which time all needles are easily counted and the entire device is properly disposed of, in a permanent fashion, in an appropriate permanent sharps disposal container. The needle escort is unique in that it incorporates protection without being cumbersome. It is lightweight and disposable. It is designed for both forward and backward passing of instruments and eliminates direct hand-to-hand passing and exposure during the above process. 
     As seen in  FIGS. 1 and 2 , the apparatus  10  comprises a two-compartment system in which sterilized sharp implements are removably positionable for suturing use in exposed holding and handling receptacle  12  and sharp implements for either storage or subsequent disposal are placed in sealable disposal and storage compartment  14 . The apparatus has a pair of longitudinal side walls  16 , a pair of end walls  34 , 36 , a floor  50 , and in a preferred embodiment, an inner wall  18  which separates the holding and handling receptacle  12  from the disposal and storage compartment  14 . 
     As illustrated in  FIGS. 1 and 3 , the holding and handling receptacle  12  comprises a pair of longitudinal side walls  16 , floor  50 , inner wall  18 , which in a preferred embodiment is shared with adjacent disposal and storage compartment  14 , and exterior receptacle end wall  36 . In one embodiment of the invention end wall  36  is discontinuous at three locations, although this number could be increased or decreased, and optionally, eliminated. As evidenced in  FIG. 1 , a pair of slots  44  are shown in spaced apart relationship to each other and positioned toward longitudinal side walls  16 . These openings are available for scalpel insertion and holding when passed from a physician&#39;s assistant to a physician. In a preferred embodiment, a third opening  52  is present which in cooperation with V-shaped notch  24  in floor  50  facilitates linkage with suture material, i.e., thread which is held in engagement with the apparatus  10  through suture card (not shown) which is secured via opposed rails  26 . 
     As illustrated in  FIGS. 1 and 6 , the sealable disposal and storage compartment  14  comprises a pair of longitudinal side walls  16 , a floor  50 , an inner wall  18 , which in a preferred embodiment is shared with adjacent holding and handling receptacle  12 , and exterior compartment end wall  34 . The end wall is slightly lowered in comparison to side walls  16  to accommodate sliding engagement of a securely fastenable covering device  20 , which for safety purposes, prevents the sharp implement from falling out of the apparatus when it is positioned in a manner other than laying flat on a horizontal surface. In a preferred embodiment, this covering device  20  will be slidably positionable via grooves  22  inside exterior walls  16  of disposal and storage compartment  14  and commonly shared interior wall  18 . The longitudinal side walls  16  preferably have an indentation  28  contained at approximately the mid-point along the length to accommodate holding the apparatus between a thumb and a finger of a user. 
     In order to securely position the sharp implements and/or needles, a pair of magnets  46  are securely positioned on floor  50  adjacent end wall  36  of holding and handling receptacle  12 . For disposal, at least one magnet  38  is positioned in disposal and storage compartment  14  for securing the sharp implements prior to closing of the receptacle by cover member  20 . Optionally, as best illustrated in  FIG. 4 , the covering device will have a pair of laterally extending hooks  30  for stop positioning of the cover member  20  against longitudinal side walls  16  and a protruding lip  40  along two longitudinal sides and one interior side of the cover member for insertion into grooves  22  on the interior of longitudinal side walls  16  of disposal and holding compartment  14 . For ease of movement, a plurality of grooves  32  are either molded as raised edges or cut into cover member  20 . In a preferred embodiment, a first raised ridge  42   a  as best seen in  FIG. 5 , is molded into cover member  20  on the under side for ensuring secure engagement with an interior side of lowered end wall  34  of the disposal and holding compartment  14  of cover member  20 . Additionally, a second raised ridge  42   b  is shown positioned interiorly of first raised ridge  42   a  to minimize the possibility of cover member  20  falling to the floor upon lateral peripheral movement by a user effected to opening the cover member. 
     As seen in  FIG. 3 , a pair of openings  44  in exterior receptacle end wall  36  permit insertion of scalpel blades with associated grooved handles, said handle grooves typically being normal to the longitudinal axis of the scalpel and dimensioned so as to frictionally fit into openings  44  in end wall  36 . In one embodiment of this invention, foam or flexible inserts  48  are positioned within opening  44  so as to accommodate differently sized scalpel handles. 
     When the device is being used in association with suture materials (not shown), typically provided in sterile elongated packaging dimensioned so as to be frictionally positionable within inwardly directed legs  26  after removal of the packing material, the sterilized needle with suture material threadably attached, is positioned using a needle holder onto magnets  46  with suture material passing through notch  24  in floor  50 . After the threaded needle has been positioned onto magnets  46 , the needle holder is disengaged from the needle and apparatus  10  held in a forward facing position exposed to the physician or suture technician. After passing, the needle is reattached to the needle holder for use by the physician or suture technician to effect the closure. Upon completion of the closure, the needle is deposited onto magnet  38  in the disposal and holding compartment  14  after opening of securedly refastenable lid  20 , followed by disengagement of the needle holder and closure of lid  20 . 
     While securedly refastenable lid  20  has been described so far as a slidably repositionable device with a ridge which is guided by a groove in the disposal and holding compartment  14 , there is no need to limit it to such. One of the key considerations is the degree of integrity of the closure coupled with the magnet which is positioned along at least a portion of the bottom of the compartment. Alternative lid configurations could include, a hinged arrangement with frictional snap fit characteristics. Yet further embodiments, include encasing the magnet into either the floor of the compartments or in separable plastic inserts dimensioned so as to be positionable within either one or both of the compartments. This is anticipated to be helpful when the device is intended for multiple uses, and sterilized multiple times. 
     In light of the sterilization requirement, it is important that any plastic which is employed to manufacture the apparatus be capable of withstanding sterilization environments. Typical of sterilizable polymers would include the following non-limiting examples: poly(meth)acrylics, e.g., poly(meth)acrylic acids and esters thereof, e.g., poly(meth)acrylates, polyamides such as nylon, polyesters and polyolefins such as polyethylene, including ultra high molecular weight polyethylene and crosslinked polyethylenes or polypropylene, polyetherimides, acetal copolymers, polyethersulfones, polyarylethersulfones, polysulfones, PPO (polyphenylene oxide &amp; styrene), polystyrenes, polycarbonates, and ABS (acrylonitrile butadiene styrene). 
     In order to implement the OSHA directives, it is important that cover member  20  be transparent or translucent so as to enable counting of the sharps contained within disposal and holding compartment  14 . Other structural members of the apparatus need not have either the transparent or translucent characteristic. 
       FIGS. 7-12  illustrate another version of a sharp surgical instrument handling device  55  constructed in accordance with the invention. The main part of the device  55  comprises a one-piece or unitary injection molded body  56 . The body  56  is formed of a suitable thermoplastic such as polypropylene with various thin wall portions having, for the most part, a generally uniform thickness. The body  56  has two principal sections, a box-like container section  57  and a specialized implement support section  58 . The illustrated device  55  has an overall length ( FIG. 10 ) of about 7⅝″. Ideally, the corners of various parts of the body are rounded to avoid cutting or tearing of gloves worn by medical personnel. The box section  57  is generally rectangular in plan view ( FIG. 9 ) and is relatively shallow by virtue of having a depth of about ⅕ its major length measured in the longitudinal direction of the device  55 , that is, the lengthwise direction of the body  56 . The box section  57  includes a bottom wall  59 , end walls  61 ,  62 , and sidewalls  63 ,  64 . The bottom wall  59 , at an area remote from the support section  58 , includes a pair of molded-in supports or feet  66  that depend downward from the bottom wall proper. A lid or cover  67  is joined to one of the side walls  64  with a living hinge  68 . The lid  67  is molded in the open position of  FIG. 7  and can be closed over the container  57  as indicated in  FIG. 11 . The cover  67  is large enough to fully close the container  57  and is releasably locked in a closed position by a resiliently deflectable latch formed on a free edge  71  of the cover  67 . A hole  72  in the latch  69  receives a small projection  73  on a sidewall  63  ( FIG. 8 ). 
     A magnetic sheet  76  ( FIGS. 9 ,  11 ) is assembled on the bottom wall  59  on the inside of the container or box  57  by suitable adhesive or other means. Printed or otherwise marked on the exposed side of the magnetic sheet  76  is a rectangular grid of a color contrasting with the sheet that is used to count or register sharp implements such as used scalpel blades and needles by receiving a separate one of the implements in a single one of the grid spaces. The cover  67  is preferably sufficiently transparent to enable the grid and any sharps on the magnetic sheet  76  to be seen therethrough. 
     The implement support section  58  has a base wall  80  that, as shown, can be coplanar with the bottom wall  59  of the box section  57 . Opposed vertical walls  81  reinforce the base wall  80  by interconnecting it with the container box section end wall  61 . The base wall  80  has square or rectangular apertures  82  that simplify the tooling required to mold a plurality of right angle tabs  83 . The tabs  83  serve as support feet for the device  55  and to resiliently grip a suture pack as described below. The bottom surfaces of the tabs  83  and feet  66  are preferably coplanar and are provided with double-side adhesive-coated foam-like pads  84  of known construction. The lower surfaces of the pads  84 , ideally, have peel-away release liner material which, when removed, enables the device  55  to be adhered to a supporting surface such as a surgical drape or table. The sidewalls  81  are formed with concave areas  86  that cooperate to create a wasp waist configuration adjacent the container box  57  so as to produce a comfortable and secure finger grip across these areas  86  ( FIG. 11 ). 
     Finger guards  88  extend laterally from upper edges of the walls  81  and longitudinally beyond the forward end of these walls and the base wall  80 . The finger guards  88  are cupped downwardly along the majority of the length of their free edges  89  towards the bottom face of the device, i.e. they are concave from the lower face of the device  55 . The free edges  89  of the finger guards remain above the plane of the bottom wall  59  and coplanar base wall  80  so as to not interfere with the function of the feet  66  and tabs  83  for supporting the device  55  in a stable manner on a flat surface. 
     At a forward end of the base wall  80  are two scalpel holding locations  91  each formed by a pair of opposed gripping elements in the form of upstanding or vertical tabs  92 . The tabs  92  lie in planes oblique to the longitudinal direction of the device  55  so that the tabs in a free state converge towards one another with reference to the rearward direction. Edges  93  of the pair tabs in a free state are spaced from one another to define a gap  94 . The central tabs  92  are supported on fingers  96  having vertical and horizontal segments. At their upper ends, the tabs  92  are formed with inclined camming edges  97  such that the gap  94  between the tab edges widens with increasing distance from the base wall  80 . A space or notch  98  exists between the fingers  96  and extends a limited distance into the base wall  80 . 
     An upstanding or vertical rib  101  near the box  57  is aligned in the longitudinal direction with each gap  94 . As indicated, each rib  101  is formed with a lengthwise deep groove  102  dividing the rib into two portions and leaving only a very thin membrane  100  of material between these portions adapted to be cut by a scalpel blade. Alternatively, a very narrow slot can be substituted for the groove and thin membrane. At their free ends, the ribs  101  each have a V-shaped notch  103  centered with the respective groove  102  and forming with the groove a narrow throat area for laterally confining a scalpel blade. The box cover  67  has two retainer tabs  104  that are located to overlie respective ones of the rib grooves  102  when the cover is closed over the box  57 . The base wall  80  is covered with a magnetic sheet  106  ( FIG. 9 ) that includes a notch with portions that straddle along each side of the notch  98 . The magnetic sheet  106  is mounted on the box wall with adhesive or other suitable means. 
     The four right angle tabs or legs  83  on the lower face of the base wall  80  are arranged in opposed pairs so that a longitudinal channel or receiving zone  109  is bounded by them and the base wall. A commercially available suture pack  110  comprising a plastic carrier supporting a needle and suture thread can be assembled into this receiving zone by pushing it between the tabs  83  and the lower surface of the base wall  80  from a loading zone formed by the lower face of the container box bottom wall  59  forward of the rear feet  66 . A molded projection  115  ( FIG. 8 ) stops the suture pack at an appropriate location. The right angle tabs or feet  83  are spaced from the plane of the base wall  80  so that they are resiliently flexed when the pack  110  is inserted and the pack is thereby reliably frictionally retained in position. 
       FIG. 12  illustrates a feature of the invention where the device  55  is used for presenting a suture needle  116  to a needle holder. As shown, the needle  116 , which can be drawn from the suture pack  110 , is positioned in straddled relation to the portion of the notch  98  in the base wall  80  and a complementary notch in the magnetic sheet  106 . The needle  116  is held in the desired location by the magnetic attraction developed by the portions of the magnetic sheet  106  on opposite sides of the notch  98 . The nose of a needle holder partially shown at  117  easily enters the area of the notch  98  and grips the mid-section of the needle  116 . The needle  116  is then simply lifted off the magnetic sheet  116  for use. 
       FIG. 11  illustrates a manner of use of the device  55  that affords the least change in a surgeon&#39;s paradigm in being directly handed a scalpel by an attendant nurse and can therefore be highly preferably over other techniques and devices that avoid direct hand-to-hand exchange of scalpels. One or two scalpels  111  are mounted on the device  55  by forcing the scalpel blade  112  into a receiving zone of the membrane created by the groove  102  in an associated rib  101  and beneath the tabs  104  on the container cover  67 . It will be understood that these elements along with the box end wall  61  confine or restrain the blade end of the scalpel  111  in essentially all directions except forward (away from the box end wall  61 ). 
     The convergent sides of the V-shaped notches  103  help to direct and center the scalpel blade  112  with the relevant blade rib  101  thereby facilitating action of the blade cutting into the membrane at the groove  102  or the alternative slot. During insertion of the scalpel blade  112  into the blade rib  101 , the scalpel handle can be held above a respective gripping slot or gap  94 . With the blade  112  set in the receiving zone formed by the rib  101 , the scalpel handle, designated  113 , is pushed down into the gap  94  in pitch motion preferably until it abuts the base wall  80  adjacent the gap. The convergent camming edges  97  at the gap  94  serve as cams to spread the tabs  92  to accommodate the particular width of the scalpel handle  113 . A study of  FIG. 9  shows that the vertical tabs  92  are oriented so that only their edges  93  engage the handle  113 . The tab edges  93  are sharp enough to interengage with and grip typical serrations or ribs  114  on the scalpel handle  113 . Because the tabs  92  are oblique to the longitudinal direction, they work like finger traps and prevent forward longitudinal movement of the scalpel, i.e. movement away from the container or box  57 . 
     Because the grip of the tabs  92  is secure and reliable, the device  55  can be held upright or nearly upright ( FIG. 11 ) by an attending nurse for presentation to a surgeon during an operation without the risk of a scalpel accidentally slipping out of the device. The scalpel  111  is simply retrieved from the device by pulling the handle  113  upwardly or away from the plane of the base wall  80 , in pitch motion, so that the handle slides out of the gap  94  in a direction perpendicular to the base wall. It will be understood that the device  55  can alternatively be supported horizontally by a nurse or a support surface, and the scalpel  111  will be safely and securely held with the handle in cantilever relation to the support section  58  with its mid-section resting on the base wall  80 . 
     The device  55  is ergonomically configured so that it can be securely gripped by the fingers of the nurse such as in the situation depicted in  FIG. 11 . The exterior of the walls  81 , and, if desired, most or all of the remaining exterior of the body  56 , except the cover  67 , is formed with a non-slip surface by suitable surface treatment of the mold. Such body surfaces, preferably, have as a minimum surface roughness that which is formed by a vapor hone mold surface. The wasp waist section afforded by the concave areas  86  provides a secure grip between the thumb and a finger or fingers. The downwardly cupped edges  89  of the finger guards  88  automatically enable the person holding the device to locate his or her fingers so that they remain behind the guards  88 . The cupped area on the forward end of the flanges or guards  88  is especially effective in receiving and constraining the small finger or pinky. Note that the finger guards are similarly useful when originally placing or replacing a scalpel on the device. With a person&#39;s fingers protected by the guards, the risk of an accidental stick or cut is effectively eliminated. 
     While the invention has been shown and described with respect to particular embodiments thereof, this is for the purpose of illustration rather than limitation, and other variations and modifications of the specific embodiments herein shown and described will be apparent to those skilled in the art all within the intended spirit and scope of the invention. Accordingly, the patent is not to be limited in scope and effect to the specific embodiments herein shown and described nor in any other way that is inconsistent with the extent to which the progress in the art has been advanced by the invention.