WO2021263009A1

WO2021263009A1 - Surgical sharps handling device and related methods

Info

Publication number: WO2021263009A1
Application number: PCT/US2021/038938
Authority: WO
Inventors: David S. Kirn; Kevin J. MAUDSLEY
Original assignee: Kirn Medical Design, Llc
Priority date: 2020-06-24
Filing date: 2021-06-24
Publication date: 2021-12-30

Abstract

A device for handling at least one sharp during a surgical procedure includes a housing having a first side and a first surface, a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath. The first leg of the push plate is generally coplanar with the first side and a second leg of the push plate Is generally coplanar with the first surface in the normal position and the second leg defines an aperture for at least partially receiving a hypodermic sheath. The housing may be modular in design.

Description

SURGICAL SHARPS HANDLING DEVICE AND RELATED METHODS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

63/043,218, filed June 24, 2020, the disclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This document relates generally to the handling, collection, and disposal of sharps found in operating theaters, such as needles, scalpel blades, and cannulas, and more specifically with devices for safely handling, collecting, and/or disposing of such sharps.

BACKGROUND OF THE INVENTION

[0003] Safe collection and disposal of all sharps is a requirement for all open surgical procedures. This necessarily includes maintaining an accurate count of all sharps. Counting boxes are the most frequently used devices for these purposes. A counting box typically consists of a plastic box which opens to form two counting trays. A first tray traditionally includes a foam pad for sticking suture needles into and a second tray may have a magnetic plate for holding removed/discarded scalpel blades and cannulas. The counting box provides an organized means of collecting used sharps, organizing them in a single area for easy counting, and safely disposing of them by closing and discarding the box at the completion of the procedure. While effective for its particular purpose, the traditional counting box design has certain limitations and/or shortcomings relating to the broader aspects of handling sharps before, during, and after the procedure.

[0004] Accordingly, a need exists for devices and related methods for safely handling, collecting, and/or disposing of sharps found in operating theaters. Sharps herein includes scalpel blades, needles, and sharp and blunt microcannulas, intravenous cannulas, and nasal cannulas.

[0005] Safe handling of sharps, including the physical support of a syringe or cannula in a sterile manner during a procedure, takes on additional importance when the procedure requires the serial use of multiple sharps. For example, the use of microcannulas has been introduced as a superior method for the injection of fillers as an effective and safe anti -aging treatment. Such treatments were traditionally accomplished using only fine needles to inject the filler at multiple precise locations under the skin. Recently, however, the treatments also utilize microcannulas which have a flexible blunt tip. In this example, a small and shallow entry point is created using a fine needle, limiting pain and bleeding, and a microcannula is subsequently inserted through the opening. The flexible blunt tip of the cannula is directed through the entry point under the skin to inject filler at multiple desired sites. The process may be repeated at different entry point locations. Generally, movement of the cannula under the skin in this manner is accomplished with minimal tissue injury and pain, if any, and the number of entry points may be significantly reduced.

[0006] Such devices) may further support the safe and efficient handling of multiple shaips during a procedure including, for example, removal of a needle and sheath from a syringe, replacement of a hypodermic sheath, and/or removal and disposal of a scalpel blade. Even more, such devices may be provided in a modular design including, in certain embodiments, integration into a traditional counting box to ensure safe collection and disposal of the sharps.

SUMMARY OF THE INVENTION

[0007] In accordance with the purposes and benefits described herein, a device for handling at least one sharp during a surgical procedure is provided. The device includes a housing having a first side and a first surface, a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a first leg of the push plate is generally coplan ar with the first side and a second leg of the push plate is generally coplanar with the first surface in the normal position and the second leg defines an aperture for at least partially receiving a hypodermic sheath.

[0008] In another embodiment, the housing includes a generally U-shaped recess opening and extending along the first surface. In still another embodiment, the housing further includes a depression formed in a second side of the housing. In yet another, the depression extends into a midpoint of the second side. In still another embodiment, the depression extends from a midpoint of the second side through the first surface of the housing.

[0009] In one other embodiment, the device further includes first and second rests, each rest defining a recess. In another embodiment, the recesses defined by the first and second rests open along the first surface of the housing. In still another, the first and second rests partially define a depression formed in a second side of the housing.

[0010] In yet another embodiment, the at least one push plate is generally L-shaped. In another, the push plate includes a dimple. In still another embodiment, the housing includes a frame and an insert. In another, the first surface forms a portion of the frame. In yet another, the receiver forms a portion of the insert.

[0011] In yet still another embodiment, the receiver includes at least two cylindrical plates for receiving the hypodermic sheath.

[0012] In another embodiment, the device further includes a retaining clip extending from the second leg of the push plate. In yet another embodiment, the retaining clip includes a barb at a distal end for engaging a flange of the hypodermic sheath to prevent withdrawal of the hypodermic sheath when the push plate is in the normal position.

[0013] In one other embodiment, at least one of the at least two cylindrical plates include a protrusion extending toward the other of the at least two cylindrical plates to hinder rotation of the hypodermic sheath. In another, the protrusion is a tab. In yet another, the protrusion is a longitudinally extending rib and yet another, the longitudinally extending rib extends the length of the at least one of the at least two cylindrical plates.

[0014] In still another embodiment, the housing includes first and second portions. In yet another embodiment, the first portion includes the first side and the push plate and the second portion includes the depression. In yet another, the first and second portions are attached to form the housing. In still one other embodiment, the receiver is supported by the second portion of the housing.

[0015] In another embodiment, a device for handling at least one sharp during a surgical procedure includes a modular housing having first and second portions, a push plate attached to a side of the first portion by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a leg of the push plate is generally coplanar with a first surface of the first portion in the normal position and defines an aperture for at least partially receiving the hypodermic sheath.

[0016] In yet another embodiment, the housing includes a recess opening and extending along a first surface of the second portion. In still another, the housing further includes a depression formed in a side of the second portion of the housing. In one other embodiment, the depression extends from a midpoint of the side of the second portion through a surface of the second portion.

[0017] In one other embodiment, the device further includes first and second rests, each rest defining a recess. In still another, the recesses defined by the first and second rests open along the surface of the second portion. In yet another embodiment, the first and second rests partially define a depression formed in the side of the second portion.

[0018] In yet still another embodiment, the at least one push plate is generally L-shaped. In another, the receiver includes at least two cylindrical plates for receiving the hypodermic sheath.

[0019] In yet another embodiment, the device further includes a retaining clip extending from the second leg of the push plate. In another, the retaining clip includes a barb at a distal end for engaging a flange of the hypodermic sheath to prevent withdrawal of the hypodermic sheath when the push plate is in the normal position.

[0020] In one other embodiment, at least one of the at least two cylindrical plates include a protrusion extending toward the other of the at least two cylindrical plates to hinder rotation of the hypodermic sheath. In still another, the protrusion is a longitudinally extending rib.

[0021] In still one other embodiment, the first and second portions are attached to form the housing and in one other embodiment, the receiver is supported by the second portion of the housing.

[0022] In another embodiment, a device for removing a scalpel blade from a handle includes a housing having a floor and a first surface defining an aperture for receiving the scalpel blade and at least a portion of the handle, a push plate is attached to the first surface by a hinge around which the push plate pivots from a normal position to a depressed position, and at least one push bar extends from the push plate for engaging the scalpel blade for at least partially removing the blade from the handle.

[0023] In still another embodiment, the hinge is a living hinge. In another, the at least one push bar extends from the push plate for limiting a depth of insertion of the scalpel blade. In yet another embodiment, the at least one push bar extends from the push plate and engages the handle for limiting the depth of insertion of the scalpel blade. In yet another, the push plate includes a dimple.

[0024] In one other embodiment, the housing includes a frame and an insert and in another, the first surface forms a portion of the frame.

[0025] In yet another embodiment, the device for removing a scalpel blade from a handle further includes first and second walls extending from the frame which, together with the insert and the floor, define a chamber for receiving the blade. In another embodiment, the insert includes a sloping wall which defines a portion of the chamber for receiving the blade. In still another, the frame includes the first surface.

[0026] In yet another embodiment, the device for removing a scalpel blade from a handle further includes a support block supported by the insert for supporting the handle when inserted into the aperture.

[0027] In still yet one other embodiment, a tool for replacing a needle into a hypodermic sheath having a flange includes a housing having a first side and a first surface defining an aperture for at least partially receiving the hypodermic sheath and the needle, a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of the hypodermic sheath and the needle.

[0028] In another embodiment, the hinge is a living hinge and in one other, the at least one push plate is generally L-shaped. In still another embodiment, a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with the first surface. In still another, the push plate includes a dimple. [0029] In still another embodiment, the housing includes a frame and an insert. In yet another, the first surface forms a portion of the frame and in yet another, the receiver forms a portion of the insert.

[0030] In one other embodiment, the receiver includes at least two cylindrical plates for receiving the sheath. In still another embodiment, the tool for replacing a needle into a hypodermic sheath having a flange further includes a retaining clip extending from the second leg of the push plate. In another embodiment, the retaining clip includes a barb at a distal end for engaging the sheath flange to prevent withdrawal of the sheath when the push plate is in the normal position.

[0031] In yet one additional embodiment, a device for handling and disposing of at least one sharp during a surgical procedure includes a housing including a first tool for removing a scalpel blade from a handle and a second tool for replacing a needle into a hypodermic sheath having a flange, and first and second trays hingedly attached to the housing.

[0032] In another embodiment, the housing has a first side and a first surface, and the second tool for replacing a needle into a hypodermic sheath having a flange further includes a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with the first surface in the normal position and the second leg defines an aperture for at least partially receiving a hypodermic sheath.

[0033] In yet another embodiment, the housing is a modular housing having first and second portions, and the second tool for replacing a needle into a hypodermic sheath having a flange further includes a push plate attached to a side of the first portion by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a leg of the push plate is generally coplanar with a first surface of the first portion in the normal position and defines an aperture for at least partially receiving the hypodermic sheath.

[0034] In still another embodiment, the housing has a floor and a first surface defining an aperture for receiving a scalpel blade and at least a portion of the handle, and the first tool for removing a scalpel blade from a handle includes a push plate is attached to the first surface by a hinge around which the push plate pivots from a normal position to a depressed position, and at least one push bar extends from the push plate for engaging the scalpel blade for at least partially removing the blade from the handle.

[0035] In yet another embodiment, the device for handling and disposing of at least one sharp during a surgical procedure further include a tool for handling at least one sharp during a surgical procedure and in still another embodiment, the housing is modular having first, second and third portions.

[0036] In another embodiment, the device for handling at least one sharp during a surgical procedure includes a receiver supported by the third portion of the housing for receiving at least a portion of a hypodermic sheath. In another, the third portion of the housing includes a recess opening and extending along a first surface of the second portion.

[0037] In still another embodiment, the third portion of the housing includes first and second rests, each rest defining a recess and in another, the recesses defined by the first and second rests open along the surface of the third portion. In another, the first and second rests partially define a depression formed in the third portion.

[0038] In the following description, there are shown and described several embodiments of devices and tools for handling, collection, and disposal of sharps found in operating theaters and related methods. As it should be realized, the methods and described devices and tools are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the methods and devices as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0039] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the invention and together with the description serve to explain certain principles thereof. In the drawing figures: [0040] Figure 1 is a perspective view of a surgical sharps handling device;

[0041] Figure 2 is a perspective view of an alternate embodiment of the surgical sharps handling device;

[0042] Figure 3 is a perspective view of the surgical sharps handling device including a needle replacement tool;

[0043] Figure 4 is a perspective view of a typical hypodermic needle and connector both alone and inserted into a sheath;

[0044] Figure 5 is a cross section plan view of a sheath inserted into a receiver,

[0045] Figure 6 is a partial perspective view of the sheath/needle removal tool illustrating ribs extending lengthwise along each of the pair of opposing plates;

[0046] Figure 7 is a perspective view of an alternate embodiment of a device for handling and disposing of at least one sharp during a surgical procedure;

[0047] Figure 8 is a perspective view of another alternate embodiment of a device for handling and disposing of at least one sharp during a surgical procedure including two counting trays;

[0048] Figure 9 is a perspective view of the embodiment shown in Figure 8 with the counting trays in an open position;

[0049] Figure 10 is an exploding perspective view of a central block of the device for handling and disposing of at least one sharp illustrating an outer frame and an insert;

[0050] Figure 11 is a cross section plan view of scalpel;

[0051] Figure 12 is a cross section plan view of scalpel blade removal tool;

[0052] Figure 13 is a cross section plan view of a needle reinsertion too; and

[0053] Figure 14 is a partial perspective view of the sheath/needle removal tool illustrating ribs extending lengthwise along each of the pair of opposing plates. [0054] Reference will now be made in detail to the present preferred embodiments of the needle and scalpel blade counting box and related methods for removing a scalpel blade, replacing a hypodermic sheath, and/or removing a needle and sheath, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.

DETATLED DESCRIPTION

[0055] Reference is now made to Figure 1 which illustrates one embodiment of a surgical sharps handling device 10 combining tools for supporting a syringe with an attached hypodermic needle or microcannula during a procedure, removing a needle from the hypodermic sheath, and replacing the needle into the sheath. In other embodiments, each tool could be a standalone item to be provided in addition to a traditional counting box, the tools could be combined as described and shown in Figure 1 as portions of the device in modular fashion, or one or more of the tools may be integrated into a traditional counting box.

[0056] As shown in Figure 1, the device 10 includes a syringe support tool 12 or first portion including a base 14 having a depression (designated reference numeral 15) formed therein. The depression 15 is designed to receive at least a tip of a digit (not shown), a partial thumb for example, in order to securely handle the device 10. In the described embodiment, the depression is generally U-shaped and extends generally from a midpoint of the base 14 through an upper surface 22. The depression 15 is gently contoured forming flat walls and smooth transitions. While the location of the depression 15 is not critical, the purpose of the depression is to assist in grasping the device 10 during use or otherwise. Opposing first and second rests 16, 18 partially define the depression 15. Each such rest further defines a generally U-shaped recess (designated reference numeral 20) opening along the upper surface 22 of the tool 12. During use, one or more syringes with an attached needle or microcannula (not shown) may be placed across the first and second rests 16, 18 which collectively provide two-point support for the syringe/cannula.

[0057] In an alternate embodiment shown in Figure 2. for example, the depression 15 may resemble a hole extending generally into the midpoint of the base 14. In this embodiment, the depression 15 would not extend through the upper surface 22. Rather, a single, generally U-shaped, recess 21 opening and extending along the upper surface 22 of the tool 12 may be formed serving as a single, elongated rest 23 for a syringe/cannula (not shown). Alternate embodiments may similarly include two or more depressions and three or more rests providing at least three support points for a syringe and variations in the size, number, and/or location of depressions (e.g., below a midpoint and/or depressions for multiple digits).

[0058] As best shown in Figure 3, the handling device 10 also includes a needle replacement tool 24 or second portion. The needle replacement tool 24 includes an aperture 26 for receiving a syringe sheath 30. As shown in Figure 4, a hypodermic needle 32 is typically attached to a Luer- lok^® or other brand connector 34 which may be inserted at least partially into a sheath 30, as shown in dash line, when not in use. The sheath 30 provides safekeeping for the needle 32 prior to its removal for use, during periods of inactivity during a procedure, and subsequent to its use. In other words, good practice dictates the replacement or re-insertion of the needle 32 back into the sheath 30 during periods of inactivity and certainly after completion of the procedure.

[0059] As shown in Figure 5, an insert 36 of the needle replacement tool 24 includes a receiver

38 for receiving the sheath 30 after its insertion through the aperture 26. In the described embodiment, the receiver 38 includes a pair of opposing cylindrical plates 40 which may be integrally molded with the insert 36. During insertion, the plates 40 progressively impinge upon and fractionally engage the sheath 30. A retaining clip 42 secures the sheath 30 in the inserted position and extends from a push plate 44 adjacent the aperture 26. As best shown in Figure 3, the push plate 44 is generally L-shaped and extends from and is attached to a side wall 46 of an outer frame 48 by a living hinge 50. In this manner, the push plate 44 pivots about the living hinge 50 from a biased or normal position to a depressed position. In the normal position, a first leg 52 of the push plate 44 is generally coplanar with the side wall 46 and a second leg 54 of the push plate is generally coplanar with the top surface 28 of the outer frame 48. A dimple 56 may be formed in the first leg 52 of the push plate 44 to serve as a push button for the user.

[0060] During insertion of the sheath 30, the user may engage the dimple 56 to move the push plate 44 and retaining clip 42 from the normal position to the depressed position. Moving the retaining clip 42 accommodates insertion of the sheath 30 through the aperture 26 and into the pair of opposing cylindrical plates 40 until a flange 58 of the sheath contacts the second leg 54 of the push plate top surface 28. In the described embodiment, the aperture 26 is sized to receive the sheath 30 but not the sheath flange 58. In this manner, the second leg 54 of the push plate 44 precludes further insertion of the sheath. Once the sheath 30 is inserted a sufficient distance such that the sheath flange 58 passes a tapered surface 60 of the retaining clip 42, the dimple 56 of the push plate 44 is released allowing the retaining clip to return to its normal position and capture the sheath in position.

[0061] Alternatively, insertion of the sheath 30 into the aperture 26 alone may be sufficient to move the push plate 44 from the normal position through contact with the retaining clip 42. An audible click alerts the user that the push plate 44 has subsequently automatically returned to the normal position wherein the sheath flange 58 is locked in position. In both described embodiments, the sheath 30 partially extends through the opposing cylindrical plates 40.

[0062] As best shown in Figure 5, a barb 62 formed on the retaining clip 42 extends beyond an outer diameter of the aperture 26 and precludes removal of the sheath 30. In other words, the barb 62 of the retaining clip 42 prevents removal of the sheath 30 from the outer frame 48 via contact with the sheath flange 58. Once captured, the user may withdraw the needle 32 from the sheath 30 by pulling it vertically upward leaving the sheath retained in the outer frame 48. The sheath 30 remains captured within the outer frame 48 for safe reinsertion of the needle 32 both during intermittent use and after completion of the procedure.

[0063] If the user desires to return the needle 32 to the sheath 30, that may be safely accomplished by vertical ly reinserting the needle into the sheath with a downward trajectory. The hypodermic needle 32 and syringe may remain in the outer frame 48 for use as needed. During surgical procedures, medications to be used on the sterile field are frequently kept in cups. If the user desires to add additional medication to the syringe, then the user may unscrew the syringe from the connector 34/needie 32 leaving the needle and sheath 30 in the outer frame 48. Depression 1.5 in the base 14 may be used to secure the device 10 while unscrewing the syringe from the connector 34.

[0064] As illustrated in Figure 6, at least one of the pair of opposing plates 40 includes a longitudinally extending rib 64 that engages lengthwise protrusions 66 on the sheath 30 to prevent rotation of the sheath and allow the connector 34 to be unscrewed. In other embodiments, the at least one rib 64 could be one or more tabs, protrusions, etc. so long as the alternate structure is sufficient to prevent rotation of the sheath 30. In this manner, the syringe may be refilled from the cup and then reconnected to the needle 32 in the outer frame 48. [0065] In other alternate embodiments, as shown in Figure 7, for example, lire syringe support tool 12 and the pair of opposing cylindrical plates 40 may be integrally molded. As shown, a support 67 extends between the pair of opposing cylindrical plates 40 and an inner wall 68 which partially defines the depression 15. In such embodiments, the base 14 of the support tool 12 and the needle replacement tool 24 are modular but attached whether releasably or fixedly. In the embodiment shown, a barbed arm 70 extends from the needle replacement tool 24 into the base 14 such that the barb releasably secures the tools. Of course, the tools may be secured together in other known manners including, for example, adhesives or plastic welding.

[0066] Once the needle 32 is reinserted into the sheath 30 and no longer needed, the entire syringe, including the needle and sheath, may be removed from the outer frame 48 and appropriately discarded. In this instance, the push plate 44 is depressed at the dimple 56 which moves the retaining clip 42 and releases the sheath flange 58 for withdrawing of the syringe, needle, and sheath from the outer frame 48. The user may dispose of the syringe, needle 32 and sheath 30 as a unit, or safely remove the sheath and needle from the syringe for disposal by unscrewing the syringe from the connector 34/needle 32 as described above. This provides additional safety as compared to the additional handling of the exposed needle for disposal. Alternatively, the hypodermic needle 32 and sheath 30 may be left in the outer frame 48 for disposal along with the device 10.

[0067] In another alternate embodiment show in Figure 8, a device for handling and disposing of at least one sharp during a surgical procedure 70 includes one or more tools for (1) removing a scalpel blade, (2) replacing a needle into a hypodermic sheath, and/or (3) removing a needle and sheath, into a traditional counting box. In another embodiment, each tool could be a standalone item to be provided in addition to a traditional counting box, the tools could be combined as a standalone item, or one or more of the tools may be integrated into a traditional counting box.

[0068] In Figure 8, the device for handling and disposing of at least one sharp 70 forms an integrated counting box having a central block 72 or unit and has two trays 74 and 76 hingedly attached thereto. The trays 74 and 76 open, as shown in Figure 9, providing traditional counting trays including a blade counting tray on the left side, which may include a magnetic pad or sheet 78 for securing loose blades (not shown), and a needle counting tray on the right side, which may include a foam pad 80 for securing removed needles (not shown). The magnetic pad 78 and/or foam pad 80 may have a printed grid to facilitate sorting and counting of the blades and needles. In other words, the tools for removing the scalpel blade, replacing the needle into the hypodermic sheath, and/or removing the needle and sheath are incorporated into a traditional counting box.

[0069] As in a traditional counting box, the blade counting tray 74 and the needle counting tray 76 are removably attached to the central block 72 via integrally molded hinges 82 and a lock 84. In the described embodiment, the hinges 82 provide a range of motion of at least ninety degrees and are positioned on the central block 72 so that the trays 74, 76 may rest horizontally on a flat surface in an open configuration shown in Figure 9. In a closed configuration, shown in Figure 8, the trays 74, 76 abut walls 86 of the central block 72. A recess may be formed in the central block 72 to accommodate needles extending from the foam pad 80 when the counting tray 76 is in the closed position.

[0070] As shown in Figure 10, the central block 72 of the device for handling and disposing of at least one sharp 70 includes an outer frame 88 and an insert 90. The outer frame 88 and the insert 90 are configured to snap together but alternate embodiments may utilize adhesives or plastic welding. Each component contributes to the functionality of the central block 72. In other words, the tools for (1) removing a scalpel blade, (2) replacing a needle into a hypodermic sheath, and/or (3) removing a needle and sheath are integrally molded into the outer frame 88 and/or the insert 90 in the described embodiment.

[0071] Addressing the scalpel blade removal tool first, a top surface 92 of the outer frame 88 defines an aperture 94 for receiving a scalpel blade 96 and handle 98. As shown in Figure 11, a boss 100 typically secures the scalpel blade 96 to the handle 98 and within a slot 102 defined by the handle 98. To remove the blade 96, a proximal portion of the blade 104 is deflected at a position adjacent the handle 98, or lifted away from the handle, a sufficient distance to clear the boss 100, and gently slid over the boss and out of the handle. This is the traditional manner for removal of a scalpel blade from a handle.

[0072] Accordingly, the tool for removing the scalpel blade must perform this function but in a safe manner, i.e., avoiding sticks and cuts to surgical personnel. As shown in Figure 12, the scalpel blade 96 (lower end) and handle 98 are inserted into the aperture 94 such that the handle is seated against a handle support block and guide 106. A push plate 108 (best shown in Figure 9) extends from and is attached to the top surface 92 by a living hinge 110. In this manner, the push plate 108 may pivot about the living hinge 110 from a biased or normal position where the push plate is generally flush with the outer frame 88 to a depressed position when pressed by a user. A dimple 112 may be formed in the push plate 108 to serve as a push button for the user. When the push plate 108 is depressed, push bars 114 extending from the push plate engage the scalpel blade 96 adjacent the handle 98 and deflect the proximal portion 104 of the blade as described above. In addition, the push bars 114 establish a depth of insertion for the scalpel handle 98 whether the push plate 108 is in the normal or depressed position.

[0073] Once the push plate 108 is depressed and the blade 96 deflected, the handle 98 is withdrawn from the central block 72 leaving the blade 96 to fall into a holding chamber 116. In the described embodiment, the holding chamber 116 is defined by lateral walls 118 forming a part of the central block 72 and a sloping back wall 120 and floor 122 form a part of the insert 74 as shown in Figure 12. The sloping back wall 120 ensures that the proximal portion 104 of the blade 96, i.e., the non-sharp end, is tilted or angled leftward during removal such that the proximal portion falls away from the sloping back wall 120. In this manner, the proximal portion 104 of the removed blade 96 may be secured through an aperture 124 defined by the central block 72 immediately below the push plate 108 as best shown in Figure 9.

[0074] A method of use of the scalpel blade removal tool includes the step of inserting the scalpel handle 98 with attached blade 96 into the aperture 94 at the top of the outer frame 88. Insertion depth and orientation of the scalpel blade 96 is governed through contact of the handle 98 with the block and guide 106, and push bars 114. When the handle 98 is seated, the user depresses the dimple 112 on the push plate 108 moving the push bars 114 to engage the proximal portion 104 of the blade 96 and bend it so that it can clear the boss 100 on the handle 98 which keeps the blade in place. The block and guide 106 support the handle 98 and blade 96 in position while the blade is deflected by the push bars 114. The user then withdraws the handle 98. The blade 96 is held captured by the upper edge of the recess 102 and is therefore pulled off the handle 98 as the handle is withdrawn. The blade 96 then falls into the chamber 118 directly below. An aperture 124 in the front of the chamber 118 allows the user access to remove the blade 96 for placement of the blade on the counting tray 78. [0075] The shape of the chamber 118 as well as the fact that the mechanism is tilted off- vertical, approximately five degrees, is designed to encourage the blade 96 to be presented out of the aperture 114 exposing the non-sharp, proximal portion 104 of the blade. Alternatively, an integrally molded spring may be employed to direct the blade in a desired orientation to the chamber aperture.

[0076] Turning to the needle replacement tool, the tool is similar in many regards to the tool described above with regard to Figure 3. In this embodiment, the needle replacement tool includes an aperture 126 as shown in Figures 9 and 10 for receiving a syringe sheath (e.g., sheath 58). As shown in Figure 4 and described above, a hypodermic needle 32 is typically attached to a Luer- lok^® or other brand connector 34 which may be inserted at least partially into the sheath 30 when not in use. The sheath 30 provides safekeeping for the needle 32 prior to its removal for use and subsequent to its use which is dictated by good practice.

[0077] Turning to Figure 13, the insert 90 includes a receiver 128 for receiving the sheath 30 after its insertion through the aperture 126. In the described embodiment, the receiver 128 includes a pair of opposing cylindrical plates 130 which may be integrally molded with the insert 90. During insertion, the plates 130 progressively impinge on and thereby frictional! y engage the sheath 58. A retaining clip 132 secures the sheath 58 in the inserted position and extends from a second push plate 134 adjacent the aperture 126. As best shown in Figure 9, the second push plate 134 is generally L-shaped and extends from and is attached to a side wall 86 of the outer frame 88 by a living hinge 136. In this manner, the push plate 134 pivots about the second living hinge 136 from a biased or normal position to a depressed position. In the normal position, a first leg 138 of the push plate 134 is generally coplanar with the side wall 86 and a second leg 140 of the push plate is generally coplanar with the top surface 92 of the outer frame 88. A dimple 142 may be formed in the first leg 138 of the push plate 134 to serve as a push button for the user.

[0078] During insertion of the sheath 58, the user may engage the dimple 142 to move the push plate 134 and retaining clip 132 from the normal position to the depressed position. Moving the retaining clip 132 accommodates insertion of the sheath 30 through the aperture 126 and into the pair of opposing cylindrical plates 130 until a flange 58 of the sheath contacts the second leg 134 of the push plate top surface 144. In the described embodiment, the aperture 126 is sized to receive the sheath 30 but not the sheath flange 58. In this manner, the second leg 134 of the push plate 134 precludes further insertion of the sheath. Once the sheath 30 is inserted a sufficient distance such that the sheath flange 58 passes a tapered surface 146 of the retaining clip 132, the dimple 142 of the push plate 134 is released allowing the retaining clip to return to its normal position and capture the sheath in position.

[0079] As described above, insertion of the sheath 30 into the aperture 126 alone may be sufficient to move the push plate 134 from the normal position through contact with the retaining clip 132. An audible click alerts the user that the push plate 134 has subsequently automatically returned to the normal position wherein the sheath flange 58 is locked in position. In both described embodiments, the sheath 30 partially extends through the opposing cylindrical plates 130.

[0080] As best shown in Figure 13, a barb 148 formed on the retaining clip 132 extends beyond an outer diameter of the aperture 126 and precludes removal of the sheath 58. In other words, the barb 148 of the retaining clip 132 prevents removal of the sheath 58 from the central block 72 via contact with the sheath flange 58. Once captured, the user may withdraw the needle 32 from the sheath 30 by pulling it vertically upward leaving the sheath retained in the central block 72. The sheath 30 remains captured within the central block 72 for safe reinsertion of the needle 32 both during intermittent use and after completion of the procedure.

[0081] If the user desires to return the needle 32 to the sheath 30, that may be safely accomplished by vertically reinserting the needle into the sheath with a downward trajectory. The hypodermic needle 32 and syringe may remain in the central block 72 for use as needed. During surgical procedures, medications to be used on the sterile field are frequently kept in cups. If the user desires to add additional medication to the syringe, then the user may unscrew the syringe from the connector 34/needle 32 leaving the needle and sheath 30 in the central block 72.

[0082] As illustrated in Figure 14, at least one of the pair of opposing plates 130 includes a longitudinally extending rib 150 that engages lengthwise protrusions 152 on the sheath 30 to prevent rotation of the sheath and allow the connector 34 to be unscrewed. In other embodiments, the at least one rib 150 could be one or more tabs, protrusions, etc. so long as the alternate structure is sufficient to prevent rotation of the sheath 30. In this manner, the syringe may be refilled from the cup and then reconnected to the needle 32 in the central block 72. [0083] Once the needle 32 is reinserted into the sheath 30 and no longer needed, the entire syringe, including the needle and sheath, may be removed from the central block 72 and appropriately discarded, in this instance, the push plate 134 is depressed at the dimple 142 which moves the retaining clip 132 and releases the sheath flange 58 for withdrawing of the syringe, needle, and sheath from the central block 72. The user may dispose of the syringe, needle 32 and sheath 30 as a unit, or safely remove the sheath and needle from the syringe for disposal by unscrewing the syringe from the connector 34/needle 32 as described above. This provides additional safety as compared to the additional handling of the exposed needle for disposal. Alternatively, the hypodermic needle 32 and sheath 30 may be left in the central block 72 for disposal along with the remainder of the sharps. In such a scenario, the needle 60 is visible for counting purposes at the completion of the procedure.

[0084] The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For example, the central block 72 may include one or more integrally molded scalpel blade attachment tools. Such a tool may include a contour recess 154 with a tapered wall 156 as shown in Figure 8, for example. In use, the scalpel blade 96 is retained in a generally vertical position within the recess 154 by the tapered wall(s) 156 with the attachment aperture 94 in the blade remaining exposed. The sharp surface of the blade 96 is shielded from the user within the recess 154. The scalpel handle 98 may be slid onto the blade 96 while the blade is retained, and the assembled scalpel may be removed for use by pulling the assembly upward.

[0085] In another embodiment of the invention shown in Figure 15, a surgical sharps handling device 160 combines tools for supporting a syringe with an attached hypodermic needle or microcannula during a procedure, removing a needle from the hypodermic sheath, and replacing the needle into the sheath in a modular manner. In essence, each of the tools are standalone or modular components that are interchangeably connected. As shown, a needle replacement tool 162 is attached to a syringe support tool 164 utilizing a tongue 168 and groove connector 170. A scalpel blade removal tool 166 is similarly attached to an opposing side of the syringe support tool 164. In alternate embodiments, any two of these tools can be combined to form a surgical sharps handling device and/or the described arrangement of the tools may be altered. For instance, the scalpel blade removal tool 166 may be in the central position with the syringe support tool 164 forming an end of the device 160. Regardless of arrangement, the various tools perform the same functions in the same manner as described herein. It should be noted, however, that one or more depressions 172 may be utilized to support use of the device during operation. Such depressions could be formed on any one or more of the modular tools. All such modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.

Claims

WHAT is CLAIMED:

1. A device for handling at least one sharp during a surgical procedure, comprising: a housing having a first side and a first surface: a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position; and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with the first surface in the normal position and the second leg defines an aperture for at least partially receiving a hypodermic sheath.

2. The device for handling at least one sharp during a surgical procedure of claim 1, wherein the housing includes a generally U-shaped recess opening and extending along the first surface.

3. The device for handling at least one sharp during a surgical procedure of any of claims 1- 2, wherein the housing further includes a depression formed in a second side of the housing.

4. The device for handling at least one sharp during a surgical procedure of claim 3, wherein the depression extends into a midpoint of the second side.

5. The device for handling at least one sharp during a surgical procedure of claim 3, wherein the depression extends from a midpoint of the second side through the first surface of the housing.

6. The device for handling at least one sharp during a surgical procedure of claim 1, further comprising first and second rests, each rest defining a recess.

7. The device for handling at least one sharp during a surgical procedure of claim 6, wherein the recesses defined by the first and second rests open along the first surface of the housing.

8. The device for handling at least one sharp during a surgical procedure of any of claims 6- 7, wherein the first and second rests partially define a depression formed in a second side of the housing.

9. The device for handling at least one sharp during a surgical procedure of any of claims 1- 8, wherein the at least one push plate is generally L-shaped.

10. The device for handling at least one sharp during a surgical procedure of any of claims 1- 9, wherein the push plate includes a dimple.

11. The device for handling at least one sharp during a surgical procedure of any of claims 1- 10, wherein the housing includes a frame and an insert.

12. The device for handling at least one sharp during a surgical procedure of claim 1 L wherein the first surface forms a portion of the frame.

13. The device for handling at least one sharp during a surgical procedure of claim 11, wherein the receiver forms a portion of the insert.

14. The device for handling at least one sharp during a surgical procedure of any of claims 1- 13, wherein the receiver includes at least two cylindrical plates for receiving the hypodermic sheath.

15. The device for handling at least one sharp during a surgical procedure of any of claims 1- 14, further comprising a retaining clip extending from the second leg of the push plate.

16. The device for handling at least one sharp during a surgical procedure of claim 15, wherein the retaining clip includes a barb at a distal end for engaging a flange of the hypodermic sheath to prevent withdrawal of the hypodermic sheath when the push plate is in the normal position.

17. The device for handling at least one sharp during a surgical procedure of any of claims 14- 16, wherein at least one of the at least two cylindrical plates include a protrusion extending toward the other of the at least two cylindrical plates to hinder rotation of the hypodermic sheath.

18. The device for handling at least one sharp during a surgical procedure of claim 17, wherein the protrusion is a tab.

19. The device for handling at least one sharp during a surgical procedure of claim 17, wherein the protrusion is a longitudinally extending rib.

20. The device for handling at least one sharp during a surgical procedure of claim 19, wherein the longitudinally extending rib extends the length of the at least one of the at least two cylindrical plates.

21. The device for handling at least one sharp during a surgical procedure of any of claims 1- 20, wherein the housing includes first and second portions.

22. The device for handling at least one sharp during a surgical procedure of claim 21, wherein the first portion includes the first side and the push plate and the second portion includes the depression.

23. The device for handling at least one sharp during a surgical procedure of claim 21 , wherein the first and second portions are attached to form the housing.

24. The device for handling at least one sharp during a surgical procedure of claim 21, wherein the receiver is supported by the second portion of the housing.

25. A tool for handling at least one sharp during a surgical procedure, comprising: a modular housing having first and second portions; a push plate attached to a side of the first portion by a hinge around which the push plate pivots from a normal position to a depressed position; and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a leg of the push plate is generally coplanar with a first surface of the first portion in the normal position and defines an aperture for at least partially receiving the hypodermic sheath.

26. The tool for handling at least one sharp during a surgical procedure of claim 25, wherein the housing includes a recess opening and extending along a first surface of the second portion.

27. The tool for handling at least one sharp during a surgical procedure of any of claims 25- 26, wherein the housing further includes a depression formed in a side of the second portion of the housing.

28. The tool for handling at least one sharp during a surgical procedure of claim 27, wherein the depression extends from a midpoint of the side of the second portion through a surface of the second portion.

29. The tool for handling at least one sharp during a surgical procedure of claim 26, further comprising first and second rests, each rest defining a recess.

30. The tool for handling at least one sharp during a surgical procedure of claim 29, wherein the recesses defined by the first and second rests open along the surface of the second portion.

31. The tool for handling at least one sharp during a surgical procedure of any of claims 29- 30, wherein the first and second rests partially define a depression formed in the side of the second portion.

32. The tool for handling at least one sharp during a surgical procedure of any of claims 25- 31, wherein the at least one push plate is generally L-shaped.

33. The tool for handling at least one sharp during a surgical procedure of any of claims 25- 32, wherein the receiver includes at least two cylindrical plates for receiving the hypodermic sheath.

34. The tool for handling at least one sharp during a surgical procedure of any of claims 25- 34, further comprising a retaining clip extending from the second leg of the push plate.

35. The tool for handling at least one sharp during a surgical procedure of claim 34, wherein the retaining clip includes a barb at a distal end for engaging a flange of the hypodermic sheath to prevent withdrawal of the hypodermic sheath when the push plate is in the normal position.

36. The tool for handling at least one sharp during a surgical procedure of any of claims 33- 35, wherein at least one of the at least two cylindrical plates include a protrusion extending toward the other of the at least two cylindrical plates to hinder rotation of the hypodermic sheath.

37. The tool for handling at least one sharp during a surgical procedure of claim 36, wherein the protrusion is a longitudinally extending rib.

38. The tool for handling at least one sharp during a surgical procedure of claim 25, wherein the first and second portions are attached to form the housing.

39. The tool for handling at least one sharp during a surgical procedure of claim 25, wherein the receiver is supported by the second portion of the housing.

40. A tool for removing a scalpel blade from a handle, comprising: a housing having a floor and a first surface defining an aperture for receiving the scalpel blade and at least a portion of the handle; a push plate is attached to the first surface by a hinge around which the push plate pivots from a normal position to a depressed position; at least one push bar extends from the push plate for engaging the scalpel blade for at least partially removing the blade from the handle.

41. The tool for removing a scalpel blade from a handle of claim 40, wherein the hinge is a living hinge.

42. The tool for removing a scalpel blade from a handle of any of claims 40-41, wherein the at least one push bar extends from the push plate for limiting a depth of insertion of the scalpel blade.

43. The tool for removing a scalpel blade from a handle of claim 42, wherein the at least one push bar extends from the push plate and engages the handle for limiting the depth of insertion of the scalpel blade.

44. The tool for removing a scalpel blade from a handle of any of claims 40-43, wherein the push plate includes a dimple.

45. The tool for removing a scalpel blade from a handle of any of claims 40-43, wherein the housing includes a frame and an insert.

46. The tool for removing a scalpel blade from a handle of claim 45, wherein the first surface forms a portion of the frame.

47. The tool for removing a scalpel blade from a handle of claim 45, further comprising first and second walls extending from the frame which, together with the insert and the floor, define a chamber for receiving the blade.

48. The tool for removing a scalpel blade from a handle of claim 47, wherein the insert includes a sloping wall which defines a portion of the chamber for receiving the blade.

49. The tool for removing a scalpel blade from a handle of claim 45, wherein the frame includes the first surface.

50. The tool for removing a scalpel blade from a handle of claim 45, further comprising a support block supported by the insert for supporting the handle when inserted into the aperture.

51. The tool for removing a scalpel blade from a handle of any of claims 45-51, wherein the at least one push bar engages the scalpel blade for at least partially removing the blade from the handle when the at least one push bar is in the depressed position.

52. The tool for removing a scalpel blade from a handle of claim 45, wherein the frame defines an aperture through which the scalpel blade is retrieved after removal.

53. A tool for replacing a needle into a hypodermic sheath having a flange, comprising: a housing having a first side and a first surface defining an aperture for at least partially receiving the hypodermic sheath and the needle; a push plate is attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position; and a receiver supported by the housing for receiving at least a portion of the hypodermic sheath and the needle.

54. The tool for replacing a needle into a hypodermic sheath having a flange of claim 53, wherein the hinge is a living hinge

55. The tool for replacing a needle into a hypodermic sheath having a flange of claim 53, wherein the at least one push plate is generally L-shaped.

56. The tool for replacing a needle into a hypodermic sheath having a flange of claim 55, wherein a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with the first surface.

57. The tool for replacing a needle into a hypodermic sheath having a flange of claim 53, wherein the push plate includes a dimple.

58. The tool for replacing a needle into a hypodermic sheath having a flange of claim 53, wherein the housing includes a frame and an insert.

59. The tool for replacing a needle into a hypodermic sheath having a flange of claim 58, wherein the first surface forms a portion of the frame.

60. The tool for replacing a needle into a hypodermic sheath having a flange of claim 58, wherein the receiver forms a portion of the insert.

61. The tool for replacing a needle into a hypodermic sheath having a flange of claim 60, wherein the receiver includes at least two cylindrical plates for receiving the sheath.

62. The tool for replacing a needle into a hypodermic sheath having a flange of claim 56, further comprising a retaining clip extending from the second leg of the push plate.

63. The tool for replacing a needle into a hypodermic sheath having a flange of claim 62, wherein the retaining clip includes a barb at a distal end for engaging the sheath flange to prevent withdrawal of the sheath when the push plate is in the normal position.

64. A device for handling and disposing of at least one sharp during a surgical procedure, comprising: a housing including a first tool for removing a scalpel blade from a handle and a second tool for replacing a needle into a hypodermic sheath having a flange; and first and second trays hingedly attached to the housing.

65. The device for handling and disposing of at least one sharp during a surgical procedure of claim 64, wherein the housing has a first side and a first surface, and the second tool for replacing a needle into a hypodermic sheath having a flange further includes a push plate attached to the first side by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with the first surface in the normal position and the second leg defines an aperture for at least partially receiving a hypodermic sheath.

66. The device for handling and disposing of at least one sharp during a suigical procedure of any of claims 64, wherein the housing is a modular housing having first and second portions, and the second tool for replacing a needle into a hypodermic sheath having a flange further includes a push plate attached to a side of the first portion by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by the housing for receiving at least a portion of a hypodermic sheath, wherein a leg of the push plate is generally coplanar with a first surface of the first portion in the normal position and defines an aperture for at least partially receiving the hypodermic sheath.

67. The device for handling and disposing of at least one sharp during a surgical procedure of any of claims 64-66, wherein the housing has a floor and a first surface defining an aperture for receiving a scalpel blade and at least a portion of the handle, and the first tool for removing a scalpel blade from a handle includes a push plate is attached to the first surface by a hinge around which the push plate pivots from a normal position to a depressed position, and at least one push bar extends from the push plate for engaging the scalpel blade for at least partially removing the blade from the handle.

68. The device for handling and disposing of at least one sharp during a surgical procedure of any of claims 64-67, further comprising a tool for handling at least one sharp during a surgical procedure.

69. The device for handling and disposing of at least one sharp during a surgical procedure of claim 68, wherein the housing is modular having first, second and third portions.

70. The device for handling and disposing of at least one sharp during a surgical procedure of any of claims 68-69, wherein the tool for handling at least one sharp during a surgical procedure includes a receiver supported by the third portion of the housing for receiving at least a portion of a hypodermic sheath.

71. The device for handling and disposing of at least one sharp during a surgical procedure of claim 70, wherein the third portion of the housing includes a recess opening and extending along a first surface of the second portion.

72. The device for handling and disposing of at least one sharp during a surgical procedure of claim 70, wherein the third portion of the housing includes first and second rests, each rest defining a recess.

73. The device for handling and disposing of at least one sharp during a surgical procedure of claim 72, wherein the recesses defined by the first and second rests open along the surface of the third portion.

74. The device for handling and disposing of at least one sharp during a surgical procedure of claim 73, wherein the first and second rests partially define a depression formed in the third portion.

75. A device for handling and disposing of at least one sharp during a surgical procedure, comprising: a syringe support tool; and at least one of a scalpel blade removal tool and a needle replacement tool connected to the syringe support tool.

76. The device for handling and disposing of at least one sharp during a surgical procedure of claim 75, wherein the syringe support tool and the at least one scalpel blade removal tool and the needle replacement tool are connected to the syringe support tool using at least one tongue and groove connector.

77. The device for handling and disposing of at least one sharp during a surgical procedure of claim 75, wherein the needle replacement tool includes a push plate attached to a first side of the needle replacement tool by a hinge around which the push plate pivots from a normal position to a depressed position, and a receiver supported by a housing for receiving at least a portion of a sheath, wherein a first leg of the push plate is generally coplanar with the first side and a second leg of the push plate is generally coplanar with a first surface of the needle replacement tool in the normal position and the second leg defines an aperture for at least partially receiving the hypodermic sheath.

77. The device for handling and disposing of at least one sharp during a surgical procedure of any of claims 75-76, wherein the syringe support tool includes a recess opening and extending along a first surface of the syringe support tool.

78. The device for handling and disposing of at least one sharp during a surgical procedure of claim 75-76, wherein the syringe support tool includes first and second rests, each rest defining a recess.

79. The device for handling and disposing of at least one sharp during a surgical procedure of claim 78, wherein the recesses defined by the first and second rests open along the first surface of the syringe support tool.

80. The device for handling and disposing of at least one sharp during a surgical procedure of claim 78, wherein the first and second rests partially define a depression formed in the syringe support tool.