Abstract:
The present invention is a scalpel blade removal device comprising an opening in a wall defining a first blade guide, extending to a narrowing upward ramp bounded by left and right guide walls. A horizontal top ramp extends from the distal end of the upward ramp, bounded by left and right guide towers. A spring loaded notch device is adapted to lock behind a proximal end of a scalpel blade seated on a scalpel, where the scalpel is inserted in the opening and the blade edge is driven up the ramp to the top ramp. When the notch device is locked behind that end of the scalpel blade, the scalpel is pulled back, causing the scalpel blade to slide off the scalpel handle. A sharps container incorporates the removal device, a reinforced latch, a scalpel resting location, and needle cover removers.

Description:
This application is a continuation in part of Ser. No. 60/425,866 filed Nov. 12, 2002. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to the removal of blades from scalpel handles. 
     During or at the end of a surgical procedure, disposable scalpel blade must be removed from non-disposable scalpel handles. During surgery, some of the disposable blades may get dull or become contaminated and must be replaced by new sharp, sterile blades. 
     A prior art scalpel handle  10  is shown in  FIG. 1  and has a handle portion  12  and a narrow inserted portion  14  connected by a neck portion  16 . The inserted portion  14  is located at the forward end of the handle  10  and is adapted to hold a blade  18 . The inserted portion  14  has a rounded front end  20  and a rounded rear end  22  with grooves  24  provided around the outer periphery. The blade  18  has a keyed slot  26  with a narrow portion  28  and a wider portion  30  located towards the rear of the slot  26 . In operation, the front end  20  of the inserted portion  14  is inserted into the wider portion  30  of the slot  26  and the narrow portion  28  of the slot  26  slides in the grooves  24  until the rear of the slot  26  clears the rear end  22  of the inserted portion  14 , at which point the blade  18  is fitted in place on the inserted portion  14 . When the blade  18  is in its normal position on the inserted portion  14  of the handle  10 , the rear end  22  of the inserted portion  14  engages a rear edge  32  of the blade slot  26 , which prevents the blade  18  from moving along its slot  26  along the grooves  24  of the inserted portion  14 . 
     In a simple but dangerous maneuver, to remove a blade  18  from the knife handle  10 , a nurse will typically use a surgical tool or his or her fingers to disengage the rear edge  32  of the slot  26  of the blade  18  from the rear end  22  of the inserted portion  14  of the handle  10 , and then begin sliding the blade slot  26  along the inserted portion  14 . This results in an uncontrolled bending of the blade  18  within its elastic limit so that when the inserted portion  14  reaches the wider portion  30  of the slot  26 , the blade  18  has a tendency to snap upward. Such bending and sliding of the blade is dangerous because it may cut the nurse. The blade may also be propelled away from the operating area where someone would have to retrieve. The blade may then be lost temporarily. Furthermore, while removing a blade  18  from a handle  10 , the nurse&#39;s hand may be cut if his or her hand accidentally slips along the blade  18 . 
     Thus, there is a need to facilitate the safe removal and disposal of blades from surgical knife handles. One such attempt to address this problem is the surgical blade removal and disposal device disclosed in U.S. Pat. No. 4,318,473. This patent discloses the use of a blade removing portion which has a guide integral with a case for guiding the handle and its associated blade therethrough. The guide includes a slot deeper than the handle for receiving the handle and for permitting the handle to move downward. The guide also includes a shoulder positionable under the blade for supporting the rear of the blade. When the handle moves downward in the slot, the inserted portion pulls the central portion of the blade down causing it to bow on the shoulder and the forward portion of the case releasing the rear edge of the blade between the blade slot and the handle and permitting the slot of the handle to slide on the inserted portion. The guide also has a stop integral with the case rearward of the shoulder and above the top of the blade prior to bowing the blade for engaging the rear of the blade. The stop also functions to prevent rearward motion of the blade when it is bowed so that the inserted portion moves in the slot to a wider portion of the slot thereby disengaging the blade from the handle. An abutment forward of the guide and integral with the case positioned over the forward portion of the blade and a guard over the rear of the blade prevent the forward and rear portions of the blade from snapping off the case when the blade is disengaged from the inserted portion. 
     However, this surgical blade removal and disposal device suffers from a number of drawbacks. First, in order to facilitate safe and proper removal of blades, the blade must be placed at a proper angle in the guide means to allow the blade removal operation to take place. Second, the blade must be aligned appropriately within the guide means. Third, although a larger blade may be removed by this surgical blade removal and disposal device, the removal of such large blades requires bending and twisting of the handle and the blade, which is both dangerous and difficult. 
     In U.S. Pat. No. 5,729,879 discloses a blade removal device with a blade seat for receiving the blade, a handle seat for receiving the handle, a dividing wall provided between the blade seat and the handle seat and having a sharp curved edge for separating the blade from the handle, and a restraining wall for restraining the blade from rearward movement once the blade has been positioned in the blade seat and the handle withdrawn rearwardly. The present inventor has found that his design in this patent needed improved guidance for the handle and blade. The present inventor also found that the entirely rigid device was in some instances difficult to operate to remove a scalpel handle. 
     In addition to the safe removal and disposal of surgical blades, the surgical staff must maintain strict accountability for all surgical sharps and/or instruments to ensure that none remain in the patient after surgery, or that none of the surgical sharps and/or instruments are lost or lying around the operating room which may cause injury to the unwary. After removal of a blade, it is placed in a disposal unit so that an accounting can be made of the disposed blades and other sharp objects which when added to the unused blades must equal the number of all blades brought into the surgery. 
     SUMMARY OF THE INVENTION 
     The present invention is a scalpel blade removal device. This device gives the user a relatively broad opening into which the user inserts the bladed end of the scalpel. The broad opening extends to a sliding ramp, where, after inserting the bladed end into the broad opening, a forward-driven blade edge moves up the sliding ramp. When the user hits the end of the sliding ramp to come to rest on a top ramp, the user merely pulls rearward on the scalpel handle to pull the blade safely free. 
     More specifically, the invention comprises a broad opening in a sidewall. The sidewall can be located in any convenient location, although a preferred location is a sidewall of a disposable sharps container, as shown in U.S. Pat. No. 5,729,879. 
     This broad opening is a first blade guide. This first blade guide has generally vertical edges preventing sideways slipping of the blade or handle when a user inserts the bladed end of the scalpel into it. Immediately adjacent to and extending from the broad opening, a narrowing upward ramp is bounded by left and right guide walls. 
     A broad opening extending to a narrowing upward ramp bounded by left and right guide walls causes the bladed end of a scalpel to be forced from a broad path to a tightly controlled one as the blade edge slides up the upward ramp. The user avoids having to use extreme care to put the scalpel into a relatively narrow path and keep it there. A horizontal top ramp extends from the distal or top end of the upward ramp. An entry to this top ramp is bounded by left and right guide towers. 
     In the operation of removing a blade from a scalpel handle, a spring loaded notch device is fixed to the left side of the left guide wall. The notch device is adapted to lock behind a proximal end of a scalpel blade as it passes by the notch device on its way up the upward ramp. The blade at this stage is fixed on the scalpel handle, but can be removed quite easily once the notch device locks onto the a scalpel proximal end of a scalpel blade as it passes by the notch device on its way up the upward ramp. Thus, the invention blade remover is simple to operate. Blades are easily removed from scalpel handles in a safe and simple operation. 
     A sharps container incorporates the removal device, a reinforced latch, a scalpel resting location, and needle cover removers. The sharps container has an upper half and a bottom half connected by three hinges. The upper half and the bottom half are then opened or closed, where the closed position causes a secure latch to keep the container closed. Magnetic sheets line the bottom half for retaining the blades and other sharps. In one form, counting indicia are printed on the magnetic sheets for counting blades and other sharps that are to be disposed. A pad lines the upper half with counting indicia are printed on the pad to count needles and other small sharps. 
     This disposable sharps container is a unitary, low cost plastic case which sits flat on any surface. Once all the blades have been removed and placed in the sharps container, the sharps container is easily and effectively sealed so that it does not open and expose the blades and/or other sharp objects such as hypodermic needles or suture needles to the environment. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a prior art non-disposable scalpel handle and a disposable blade separated from the handle. 
         FIG. 2  is a top view of a bottom half of a disposable sharps container box with the invention blade remover incorporated into its side wall and adjacent floor. 
         FIG. 3  is a perspective and broken away view of the invention blade remover. 
         FIG. 4  is a top view of the device of  FIG. 2  with the notch device in an unflexed position. 
         FIG. 5  is a cross section  74  view of the device of  FIG. 4 . 
         FIG. 6  is a top view of the device of  FIG. 2  with the notch device pressed back to receive a back end of a scalpel blade. 
         FIG. 7  is a cross section  74  view of the device of  FIG. 6 . 
         FIG. 8  is the view of  FIG. 6  with a scalpel handle and connected blade inserted in the blade remover, with the left side of the scalpel end and blade pressing back the notch device. 
         FIG. 9  is the device of  FIG. 8  with the scalpel handle pulled rearward so that a rearmost edge of the blade is effectively engaged in the notch device. 
         FIG. 10  is a perspective view of a disposable sharps container with a hinged top and bottom parts of a disposable sharps container with the invention blade remover, hypodermic needle sheath removers, scalpel rests, secure sidewall closures for the openings of the invention blade remover, hypodermic needle sheath removers, and scalpel rests, and secure latch means. 
         FIG. 11  is a perspective view of a U-shaped part of the hinge of the box of  FIG. 10 . 
         FIG. 12  is perspective view of the hinge of the box of  FIG. 10 . 
         FIG. 13  is cross section  89  of the latch means of the box of  FIG. 10 . 
         FIG. 14  is cross section  87  of the latch means of the box of  FIG. 10 . 
         FIG. 15  shows the cross sections of  FIGS. 13 and 14  joined in a closed position of the latch means of the box of  FIG. 10 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention is now discussed with reference to the figures. 
       FIG. 1  shows, as described above, a prior art scalpel handle  12  and blade  18 . Section  40  runs along a bottom edge of handle  12  and a mid section of inserted portion  14  and neck portion  16 . In  FIGS. 8 and 9 , section  40  will permit viewing of the operation of the invention blade remover. 
       FIG. 2  shows a top view of a disposable sharps container  42  with the invention blade remover  50 . The blade remover  50  will now be discussed with reference to  FIGS. 3 through 7  that show several aspects of blade remover  50 . 
     Blade remover  50  comprises a first blade guide is an opening defined by a bottom of upward ramp  65  and sidewall edges  64  and  72 . It is through this opening that the forwardmost part of the bladed end of the scalpel is inserted in a first operating step of the blade remover. A particularly critical aspect of the invention is upward ramp  65 . Ramp  65  extends upward from about a 15 to 75 degree angle relative to a floor of a sharps container  42  ( FIG. 2 ). Ramp  65  extends from its lowest and broadest point at the opening forming the first blade guide upward to its highest and narrowest point at its intersection to top ramp  68 . In operation, blade edge  34  will slide from the lowest to highest point of ramp  65  and thereafter to rest on top ramp  68 . 
     Upward ramp  65  is bounded on its right side by curved wall  63 , where the surface  70  (shown in  FIGS. 4 and 5 ) abuts the right side of blade  18  or scalpel handle  10  as the scalpel is inserted into the invention blade remover. Upward ramp  65  is bounded on its left side in part by a low wall  78 , where the surface  66  abuts the blade  18  as the scalpel is inserted into the invention blade remover. Low wall  78  is only part of the guiding means for the blade and scalpel handle as they are inserted into the blade remover. Flexible wall  53  extends inward from an attachment  52  with a sidewall. Attachment  52  is near to edge  72 . Flexible wall  53  comprises a surface  51 . Flexible wall surface  51  combines with low wall surface  66  to abut a left side of blade  18  or scalpel handle  10  as the scalpel is inserted into the invention blade remover. Flexible wall surface  51  combines with low wall surface  66  to provide as effective guiding means for a left side of the scalpel as surface  70  (shown in  FIGS. 4 and 5 ) provides for the right side of the scalpel. 
     However, flexible wall  53  serves a more important function than guiding a right side of the scalpel in operation of the blade remover. At the end of flexible wall  53  is notch  56  at short end  55 . Notch  56  is the notch that is urged into position behind back end  33  of blade  18  ( FIG. 1 ) that will retain blade  18  in place while scalpel handle  10  is pulled free from blade  18 . 
     The structure of flexible wall  53  is unique. At attachment  52 , flexible wall  53  has a vertical height of about the height of the sidewall. At short end  55 , the vertical height is about from one tenth to about two thirds the vertical height of the sidewall. Cutout  67  extends around the lower periphery of flexible wall  53  except at attachment  52 . Thus, flexible wall is free to move in a side to side motion like a tightly spring loaded swinging door.  FIGS. 4 and 6  show that distal end  54  can be pressed sideways respectively in directions  69  and  69 ′.  FIG. 4  shows flexible wall  53  in a rest state.  FIG. 6  shows flexible wall  53  after it has been pressed left.  FIGS. 6 and 7  show the position of flexible wall  53  after a blade and scalpel handle have been inserted into the blade remover. This operation is discussed in more detail with respect to  FIGS. 8 and 9 . 
     Flexible wall  53  is cleverly formed during a single molding step with the rest of sharps container box  42  ( FIG. 2 ). The peripheral cutout  67  provides the insertion point for the support wall of the mold for the sides of flexible wall  53 . 
     At the top of upward ramp  65  is top ramp  68 . Horizontal top ramp  68  is bounded on the left by edge  58  of lateral extension  57  and a right surface of wall  59 . Horizontal top ramp  68  is bounded on the right by a left surface of tower  62 . The left and right side boundaries of top ramp  68  continue the guiding means for the blade and scalpel handle as they slide off of the upward ramp  65  and onto top ramp  68 . 
     Operation of the blade remover is now discussed with reference to  FIGS. 8 and 9 .  FIGS. 8 and 9  use a section  40  of scalpel handle  10  with blade  18  ( FIG. 1 ) so that operation of the blade remover is easily seen.  FIG. 8  is a view of the operation of the blade remover after:
         1. a user holding the handle  10  has inserted the tip of blade  18  into the opening of the first blade guide;   2. the user continues insertion of the scalpel into the blade remover so that edge  34  of blade  18  slides up ramp  65  and almost to top ramp  68 ;   3. the scalpel has traveled from a broad path at the first blade guide to a narrow path toward the top of upward ramp  65 ; and   4. in traveling to the narrow path, a left side of the scalpel presses against surface  54  to move flexible wall  53  to the position shown in  FIGS. 6 and 7 .       

       FIG. 9  is a view of the operation of the blade remover after:
         1. the user continues insertion of the scalpel so the edge  34  of blade  18  rests on top ramp  68 ;   2. the back end  33  of blade  18  passes by notch  56 , whereafter surface  54  springs into contact with neck  16  immediately behind back end  33 ; and   3. the user pulls back on handle  10  so that back end  33  firmly engages notch  56 .       

       FIG. 9  shows that blade  18  is fixed in the blade remover. The user then continues to pull back on handle  10 , causing blade  18  to remain in place as shown in  FIG. 9  and eventually disengage from handle  10  entirely. When blade  18  has disengaged from handle  10 , blade  18  falls harmlessly along path  82  into the sharps container. 
     The above blade remover is a dramatic advance in the art. A scalpel is guided from a broad opening to a narrow path that forces the scalpel to push back the notched end of a flexible wall, where the back end of the blade is caught in that notch. Blade removal is a safe and simple operation thereafter. 
       FIGS. 10 through 15  show a sharps container with a top  83  and bottom  84 . Three hinges  85  are formed from U-shaped half  95  on bottom  84  and laterally supported pivot rods  95 . Hinges  85  permit top  83  and bottom  84  to be separated. Hinges  85  are operated so that top  83  can close with an almost hermitic seal to bottom  84 . Extensions  91  are adapted to closely seal openings for blade remover  92 , needle sheath removers  93 , and two side be side scalpel rests  94  in bottom  84 . The tight sealing of top  83  to bottom  84  prevents any sharps contained in the closed box from being shaken so that a sharp point emerges from the box to harm medical personnel. 
     Each of the two scalpel rests  94  comprise two aligned notches. One aligned notch is made in box sidewall B and the other aligned notch is in an interior wall A. The notch in sidewall B is aligned with a notch in wall A so that a scalpel with handle and blade can be rest in those notches. A rearward part of the scalpel handle is supported on a bottom edge of the handle in the notch in sidewall B. A more forward part of the scalpel handle and/or its blade are supported at a bottom edge in the notch in wall A. The scalpel rests are extremely important to a surgical procedure. For a long, long time, surgeons and nurses have not had a place to safely and temporarily store a bladed scalpel. If the bladed scalpel is laid down on a surgical tray or on a table top, its straight structure makes is subject to being swept along by movement of gauze or hemostats. That sweeping often means the scalpel ends up on the floor. The present scalpel rests eliminate that risk by providing a place to temporarily store bladed scalpels with other sharps. This temporary storage forces personnel to pay careful attention to a central location for all stored sharps, including needles and blades. 
     Latch means for the sharps container comprise top extension  86  and bottom receiver  88 . Sections  87  and  88  show the latch means in more detail. Top extension  86  comprises a shield box  105  that extends from the sidewalls  102  of top  83 . A similar shield box  101  extends from the sidewalls  98  of bottom  84 . These shield boxes prevent sharps contained in the closed sharps container to emerge from or harm a person who will re-open the sharps container.  FIG. 13  shows that opening  99  is generally made in the sidewall bounded by shield box  101  so edge part  100  forms a generally straight edge for engaging a lip  103 ′ of extension  103  of receiver  88 . An opening  106  is formed in sidewalls  102  for molding of extension  103  as attached to the floor edge of top  83 .  FIG. 15  shows the sharps container of  FIG. 10  in a closed position. In a box closing operation, a tip of extension  103  moves past a box edge of receiver  88  until lip  103 ′ springs into engaging connection as shown in  FIG. 15 . This structure of latch means has proven to be surprisingly effective in preventing opening of the sharps container after dropping or striking with a heavy object. 
     The above design options will sometimes present the skilled designer with considerable and wide ranges from which to choose appropriate apparatus and method modifications for the above examples. However, the objects of the present invention will still be obtained by that skilled designer applying such design options in an appropriate manner.