CA2276837A1 - Syringe cutting apparatus - Google Patents
Syringe cutting apparatus Download PDFInfo
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- CA2276837A1 CA2276837A1 CA 2276837 CA2276837A CA2276837A1 CA 2276837 A1 CA2276837 A1 CA 2276837A1 CA 2276837 CA2276837 CA 2276837 CA 2276837 A CA2276837 A CA 2276837A CA 2276837 A1 CA2276837 A1 CA 2276837A1
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- syringe
- needle assembly
- counting
- cutting
- needle
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Abstract
A device for destroying needle and syringe assemblies by severing a portion of the assembly including the needle and storing the severed portion within a housing for disposal. Safety features, such as an anti-reverse mechanism for preventing premature removal of the syringe from the device, and an overfill prevention mechanism for disabling the device from further use after a predetermined number of cutting sequences, are disclosed.
Description
SZ'RL~1GE CI~TT~G APPARA,TGS
Background of the nvention Field of the Invention The present invention relates generally to personal medical devices, and more particularly to a device for the destruction and disposal of hypodermic needle syringes.
Description of Related Art The treatment of various medical conditions often requires the percutaneous injection of medicines by means of a hypodermic needle and syringe. For example, persons with diabetes commonly inject themselves with insulin on a periodic basis, using a disposable, single-use insulin syringe. After injection, the syringe must be properly and safely disposed of. The sharp needle of the syringe is typically contaminated with biologic fluids and/or medicines, and presents a significant health concern.
Thus, it is desirable that used needles be collected into a puncture-proof container for safe disposal.
In addition, it is desirable that used syringes be disabled to prevent their accidental re-use, or the intentional misuse of the syringe by illegal drug users.
Various "sharps containers" have been developed for the storage and disposal of used syringe and needle assemblies. These containers typically provide a storage volume surrounded by a puncture-resistant housing, and having a tamper-proof inlet to prevent removal of contents. Many such containers are designed to receive the entire needle and syringe assembly, and are intended for stationary use, such as on a countertop or shelf.
Such containers are typically too bulky fax convenient portable, personal use.
Also, containment of intact needle and syringe assemblies presents a potential fortheirremoval and re-use.
Several known containment devices enable the destruction of needle and syringe assemblies by severing, breaking, unthreading or otherwise detaching sharp and/or contaminated portions thereof, and storing the detached portions for disposal.
Certain disadvantages to known containment devices of this variety have been found to exist.
For example, overfilling of the containment chamber can result in protrusion of needle points, and potential injury may result. Premature removal of a needle and syringe assembly, before complete detachment of sharp and/or contaminated porrkions thereof, also presents a risk of needle stack by the partially detached portion.
Thus, it has been found that needs exist for an improved apparatus and method for disabling needle and syringe assemblies and storing sharp and/or contaminated portions thereof for disposal.
um ary~he Invention The present invention provides an improved apparatus and method for disabling needle and syringe assemblies and storing sharp and/or contaminated portions thereof for disposal, In preferred embodiments, the apparatus of the present invention is compact and easy to operate, thereby enabling convenient portable, personal use.
According to example embodiments described in greater detail herein, the apparatus and method of the present invention can incorporate a counter mechanism, and an overfill prevention mechanism to prevent overfilling by disabling further operation after a predetermined number of needle and syringe assemblies have been processed. Other example embodiments described in greater detail herein prevent premature syringe removal by the user prior to complete detachment of the needle end thereof. The apparatus and method of the present invention can be configured for use with a wide array of syringe and needle assemblies. In particular applications, the apparatus and method of the present invention are adapted for use with single-use, integral needle insulin syringes such as those manufactured by Beckton Dickinson Co, or the Monoject division of Sherwood Medical Co.
1n accordance with the purposes of the invention, as embodied and broadly described herein, the invention in one aspect relates to an apparatus for disabling a syringe and needle assembly. The apparatus preferably comprises a first portion comprising a blade having a cutting edge, and a second portion, pivotally connected to the first portion, and comprising means for engaging a syringe~and needle assembly, whereby pivotal movement of the second portion relative to the first portion~causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly.
In another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and a counting mechanism for counting a number of cutting cycles effected by said apparatus.
In another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe, and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and an anti-reverse mechanism for preventing premature removal of a syringe and needle assembly prior to complete detachment of at least a needle porkion thereof.
rn another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and an overfill prevention mechanism for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus, In another aspect, the invention relates to an apparatus for detaching and disposing of a portion ~ of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a poztion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly. and a Iockout mechanism for pr,cvendng operation of said apparatus prior to loading a syringe and needle assembly therein.
In another aspect, the invention relates to an apparatus for disabling a syringe and needle assembly, the apparatus preferably comprising a first portion comprising a blade having a cutting edge, and a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle asserxibly, wvhereby pivotal z~aovement of said second portion rclaliuc to said first portion causes the syangc and needle assembly to traverse a path intersecting the cutting edge of tkxe blade to sever and detach a portion of the syringe and needle assembly. The apparatus preferably further comprises a counting mechanism for counting a number of cutting cycles effected by said apparatus. each cutting cycle comprising a cutting stroke comprising pivotal anovement of said second portion relaCive to sand first portion in a first rotational direction, and a return stmke comprising pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction, wherein said counting mechanism is incrementally advanced by movement of a counting pawl actuated by contact with said first portion. The apparatus preferably further comprises an anti-xeversc mechanism for permitting pivotal movement of said second portion relative to said first portion in the first rotational direction only until completion of the cutting stroke, wherein rotation of said counting pawl disengages the anti-reverse mechanism upon completion of the cutting stroke.
Additional features and advantages of the invention will be set forth in part in the detailed description, including the drawing figures, which follows, and in part will be obvious from the description,-or may be learned by practice of the invention.
The advantages of the invention will be realized and attained by means of the elements and combinations parkicularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.
Brief Descriution of the Draw~fn~~r~
Pigure 1 shows an exploded perspective view of an apparatus according to a preferred form of the present invention.
Figures 2a-2c show perspective views of the apparatus of Fig. 1, assembled and demonstrating a cutting sequence according to a preferred method of operation thereof.
Figures 3a and 3b show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 4a-4f show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures Sa-Sc show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 6a and 6b show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 7a.:7c show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figure 8 shows an orbital sequence of a portion of a counting mechanism according to a preferred embodiment of the present invention.
Detai ed Descrintinn o~f Preferred E bod im r.t~
The present invention may be understood more readily by reference to the following detailed description of preferred embodiments of the invention, including the appended drawing f~gures referred to herein, and the examples provided thez~ein. It is to be understood that this invention 1s not limited to the specific eznbodimcnts shown or described, which are intended as exemplary only, and not limiting of the invention as defined by the appended claims. It must also be noted that, as used in the spcciftcation and the appended clainns, the singular forms "a," "an" and "the"
include plural referents unless the context clearly dictates otherwise, lZanges may be expressed herein as from "about" or "approximately" one particular value and/or to "about"or "approximately" another particular value. When such a range is exprosscd, another embodiment znucludes from the one particular value andlvr to the other particular value. Similarly, when values are expressed as spproxiixtations, by use of the antecedent "about," or "approximately" it will be understood that the particular value forms another eratbodiment.
Referring now in detail to the drawing figures, wherein like reference numerals represent like pacts throughout, an apparatus 10 according to a preferred form of the present invention generally comprises a cutting mechanism 12 for disabling a syringe and needle assembly 14, and a housing 16 For containing detached portions 18 of disabled syringe and aeedle assemblies. The housing I6 preferably comprises a shell of plastic or other substantially puncture-resistant material enclosing a contained volume sufficient to contain a predetermined quantity of detached portions 18 of disabled syringe and needle assemblies. Por cxaz~aple, in an example embodiment of the present invention, the contained volume is sufficient to contain at least one hundred detached portions 18 of disabled single-use, integral needle Insulin syringes. 'The housing 16 preferably includes a mouth 20 adapted to engage a porkion of the cutting mcchartism 12 and receive detached portions 18 of disabled syringe and needle assemblies from the cutting mechatusmo~ 12. In preferred form, the apparatus of the present invention is of a readily portable size and shape enabling a user to carry the apparatus in a pocket or purse.
The cutting mechanism 12 is preferably adapted to engage the mouth 20 of the housing 16, and to engage and detach a portion of a syringe and needle assembly and deliver the detached portion to the contained volume of the housing. The cutting mechanism 12 optionally includes one or more sub-assemblies such as, for example, for counting the number of syringe and needle assemblies processed, and indicating the number of uses remaining; for preventing withdrawal of a syringe and needle assembly once engaged in the cutting mechanism; and/or for preventing overfilling by disabling the apparatus after a predetermined number of uses.
An example embodiment of the cutting mechanism 12 will be described with reference to the drawing figures. As seen best with reference to Fig. 1, the cutting mechanism 12 comprises a blade carrier 30, also shown in Fig. 7. The blade carrier 30 preferably includes a shoulder 32 projecting from a first face thereof, and adapted to engage the mouth 20 of the housing 16, whereby portions of syringe and needle assemblies detached by the cutting mechanism 12 are deposited in the contained volume of the housing 16. The blade carrier 30 preferably further comprises one or more slots, tabs or other engagement features for retaining a cutting blade 34, such as a razor or knife blade, in place over the mouth 20 of the housing 16. The blade 34 is preferably steel or other material capable of retaining a sharp edge. The remaining portions of the cutting mechanism are preferably formed of plastic, as by injection molding.
The blade carrier 30, according to the depicted embodiment, preferably further comprises one or more slots, tabs or other engagement features for slidably engaging a syringe stop 36. The syringe stop 36 limits the travel of the syringe and needle assembly 14 upon insertion, to properly position the syringe relative to the cutting blade 34 to sever the syringe and needle assembly 14 just above the needle.
The syringe stop 36 also functions to prevent operation of the apparatus when no syringe and needle assembly 14 is inserted therein for destruction. As seen with reference to Fig. 7, in the depicted embodiment, the syringe stop 36 includes a pair of ribs 37 which slide in the direction of insertion of the syringe and needle assembly 14 within cooperating grooves in the blade carrier 30, permitting the syringe stop 36 to travel between a first position '(shown in Fig. 7b) and a second position (shown in Fig. 7e).
Thb blade carrier 30 preferably further comprises a resilient spring area 38, for contacting a portion of the syringe stop 36 and biasing the syringe stop toward the first position. Ih the first position, a portion of the syringe stop projects outwardly of the blade carrier to prevent rotation and operation of the apparatus until the syringe stop is moved into the second position upon insertion of a syringe and needle assembly 14.
In this manner, the syringe stop functions as a lockout mechanism to prevent operation of the cutting mechanism without first loading a syringe and needle assembly. A mechanical stop, such as a termination or discontinuity in the grooves of the blade cazrier 30, limits the travel of the syringe stop at tha second position to prevent overstressing of the spring arm 38, and to accurately and consistently position the syringe and needle assembly 14 relative to the cutting blade 34. The syringe stop preferably further comprises a generally U-shaped lug 39 having interior walls converging from a larger dimension at a first end to a smaller dimension at a second end. The larger dimension is configured to freely pass a syringe and needle assembly I4 of standard diameter, whe~ceas the smaher dimension prevents passage of the syringe and needle assembly 14. The open end of the U-shaped lug 39 is preferably flared to permit a syringe and needle assembly inserted therein to readily be removed therefrom upon rotational actuation of the apparatus as will be described in greater detail below.
In the depicted embodiment, the blade carrier 30 preferably further comprises a toothed ring 40 projecting from a surface 41 opposite the shoulder 32. The toothed ring 40 preferably comprises a generally annular projection surrounding an opening 42 for passing detached portions 18 of syringe and needle assemblies 14 into the housing 16. The toothed ring 40 cooperates with an anti,-reverse pawl 44. to prevent reverse operation of the apparatus 10 after processing of a syringe and needle assembly 14 has begun, thereby requiring completion of the processing sequence and preventing premature withdrawal of the syringe and needle assembly 14, as described in greater detail below. A first dog 46 and a second dog 48 are preferably provided, offset approximately 90° circumferentially from one another and extending radially inward from the toothed ring 40, for indexing the counter mechanism, and for lifting the anti-reverse pawl 44. out of engagement with the toothed ring 40 at the end of a processing sequence to allow the apparatus to return to its stetting configuration.
The cutting mechanism of the depicted embodiment preferably further comprises a lower support plate 60, rotationally mounted to the blade cagier 30. The lower support plate 60 is preferably formed from two half plates 60a. 60b, each comprising a generally semicircular cutout 62 adapted to engage a circumferential slotted portion about the toothed ring 40, and rotationally couple the blade carrier to the remainder of the cutting mechanism I2. >jn this manner, the housing 16 and blade carrier 30 comprise a first porkion of the apparatus, and the remainder of the cutting mechanism forms a second portion of the apparatus, whereby the second portion is pivotally connected to the first portion about an axis of rotation extending generally through the center of the toothed ring 40. Each half plate 60a, 60b preferably comprises intcx~cngaging tabs and slots 64, enabling engagement with one another about the toothed ring 40 whereby a pivot surface 66 of the lower support plate 60 confronts the surface 41 of the blade carver 30. ~'he lower support plate 60 preferably comprises one or more resilient clips 68, or other means for engaging an upper support plate described in greater detail below.
The cutting mechanism 12 preferably further comprises an upper support plate 80, mounted between the half plates 60a, 60b of the lower support plate opposite the pivot surface 66. As seen best with reference to Figs, 1 and 5, the upper support plate 80 preferably coztxprises a base platform 82 with a duct 84 providing an opening For engaging a syringe and needle assembly and permitting passage of a portion of flee syringe and needle assembly therethrough. The duct 84 is offset from the axis of rotation between the first and second portions of the apparatus, whereby twisting of the apparatus through a cutting sequence, as described below, causes the syringe and needle assembly to traverse an arcuate path intersecting the cutting edge of the blade 34. The upper support plate 80 preferably further comprises a generally cylindrical counter housing 86 arranged adjacent a first end thereof and having a central longitudinal axis generally perpendicular to the plane of the base platform 82. A
counter-mounting boss 88 is preferably provided, extending generally perpendicularly from the base platform 82, along the central longitudinal axis of the cylindrical counter housing 86. The boss 88 can be generally cross-shaped in cross-section, as depicted, or can be of circular or other cross-sectional geometry as will permit rotation thereabout by elements of the counter mechanism as will be described in greater detail below. A portion of the inner wall of the generally cylindrical counter housing 86 proximal the base platform 82 is provided with a plurality of ratchet teeth 90. 1fie number of ratchet teeth 90 provided will factor into the counting and overFll-prevention lockout systems, as described in greater detail below. In a preferred embodiment, twelve ratchet teeth are provided, each spanning approximately 30° of the inner circumference of the counter housing 86. A portion of the inner wall of the generally cylindrical counter housing 86 distal the base platform 82 is provided with a plurality of concave seats 92. The number of concave seats 92 provided will also factor into the counting and overfill-prevention lockout systems, as described in greater detail below. Tn a preferred embodiment, eleven concave seats are provided, each spanning approximately 33 ° of the inner circumference of the counter housing 86. A pair of elongate slots, comprising an inboard slot 94 and an outboard slot 96 are preferably provided through a floor portion of the cylindrical counter housing 86.
First and second support ribs 98,100 are preferably provided, extending generally perpendicularly to the base platform 82 of the upper support plate 80 oil opposite sides of the duct 84 for supporting syringe guides described below. The edge of each support rib 98, 100 distal the base platform 82 is preferably provided with a spaced pair of grooves 102, 104. Corresponding grooves 102A and 1028 of the first and second support ribs 98, 100, respectively, are aligned opposite the duct 84 from one another; and corresponding grooves 104A and 104B of the first and second support ribs 98, 100, respectively, are also aligned opposite the duct 84 from one another.
One or more resilient clips 10d or other retaining means are preferably provided for attaching the upper support plate 80 to other components of the cutting mechanism, as described below. A slide support fin 108 is preferably provided, projecting fmm the base platform 82 opposite the support ribs 98, 100 from the counter housing 86.
The apparatus 10 optionally provides an anti-reverse mechanism, which is described with particular reference to a preferred embodiment shown in Figs. 1 and 6.
The anti-reverse mechanism preferably comprises the anti-reverse pawl 44 in cooperation with the teeth of the toothed ring 40 of the blade carrier 30, in the fashion of a ratchet. The anti-reverse mechanism prevents incomplete cycling of the cutting mechanism 12, requiring operation through the entire cutting cycle before returning to the start position, thereby preventing premature removal of a syringe and needle assembly before complete detachment of sharp or potentially contaminated portions thereof. The anti-reverse pawl 44 is positioned between the counter housing 86 of the upper support plate 80 and the Iower support plate 60. A small boss 110 projecting from the pawl 44 engages a cooperating recess or hole in the lower support plate 60, thereby permitting the pawl to pivot sufficiently to engage (Fig. 6a) and disengage (Fig. 6b) a tip portion 112 of the pawl 44 with teeth of the toothed ring 40 of the blade carrier 30. A tail portion 114 of the pawl 44 is anchored between the counter housing 86 of the upper support plate 80 and the lower support plate 60, and acts as a spring to bias the tip portion I 12 toward engagement with the teeth of the toothed ring 40.
When the tip portion 112 of the pawl 44 is engaged with the teeth of the toothed ring 40 of the blade Gamier 30, the cutting mechanism 12 can be rotated relative to the housing 16 only in the clockwise (CW) direction {as indicated with reference to Fig.
6b). An elongated slot 116 is provided in the pawl 44 between the boss 110 and the tip portion 112 to receive a second past of the counting pawl, described below, to lift the pawl tip 112 free of the teeth of the toothed ring 40 at the end of the cutting stroke so that the cutting mechanism 12 can thereafter be returned to the starting position.
The apparatus 10 optionally further provides an overfill prevention lockout mechanism, described according to a preferred embodiment with particular reference to Figs. 1, 3 and 4. A pair of syringe gwides 130, I32 are mounted in the grooves 102, 104, between the support ribs 98, 100, and over the duct 84 leading to the contained volume of the housing 16. Each syringe guide 130, 132 comprises a pair of outwardly projecting fingers 134 at a first end thereof, adapted to be pivotally mounted within corresponding grooves i02, 104. The body of each syringe guide 130, 132 depends from the fingers 134 toward the duct 84. Confronting faces of each syringe guide 130, 132 are provided with a semicircular groove, thereby forming a circular channel 136 between the syringe guides 130, 132 having a diameter permitting sliding engagement of a syringe and needle assembly of the type to be processed. The exterior face of each syringe guide 130, 132, opposite the grooved side, can be provided with a knob 138 for contacting adjacent components of the overfill prevention lockout mechanism, for accurate positioning and alignment.
The overfill prevention mechanism preferably further comprises a locking slide 154, depicted in preferred form by Figs. 1 and 4. The locking slide 150 preferably comprises a base 152 having a first end slidably supported on the slide support fin 108 of the upper support plate and a second end supported on an orbital reducer component of the counting mechanism described below. A portion of the base is removed to provide a clearance opening 154 for the support ribs 98, 100 and the syringe guides 130,132 to pass through. The locking slide preferably further comprises a spring arm 156 having a first end extending from the first end of the base 152, a looped medial portion, and a free end extending through the clearance opening 154. A positioning flange 158 preferably extends from the base 152, opposite the spring arm 156 and adjacent the first end of the locking slide 150, to limit travel of the locking slide 150 along the slide support 8n 108 towards the left (with reference to Fig. 4) to the position shown in Fig. 4b. When no syringe and needle assembly is inserted in the apparatus, the spring arm 156 contacts the syringe guide 130 and biases it toward syringe guide 132 to close the channel 136 and prevent escape of detached portions of syringe and needle assemblies from the contained volume of the housing 16. As a syringe and needle assembly 14 is introduced into the apparatus (Fig.
4b), the syringe guides 130, 132 open to pass the syringe and needle assembly 14 through the channel 136. Hy action of opening the syringe guides 130, 132, the locking slide 150 is contacted by the syzinge guide 132 and forced toward the right (Fig.
4a). In normal operation, the locking slide 150 is free to slide to the right, as described, over the surface of the orbital reducer. After cycling through a predetermined number of cutting cycles, and as described in greater detail below, the orbital reducer blocks sliding of the locking slide 150 to prevent introduction of additional syringe and needle assemblies.
The cutting mechanism 12 of the present invention optionally further comprises a counting mechanism 170, shown according to a preferred form in Figs. 1, 4 and 5. The counting mechanism 170 preferably comprises a counting pawl 172, a counting ratchet 174, and an orbital reducer 176, adapted to cooperate with and be received Within the counter housing 86 of the upper support plate 80. The counting mechanism 170 cooperates with the locking slide 150 and the syringe guides 130, I32, as described above, as part of the overfill prevention lockout mechanism;
and cooperates with an indicator, described below, to provide the user an indication of the number of cutting cycles remaining for use.
The counting pawl 172 preferably comprises a generally symmetrical component having a base 180 with a hole 182 extending generally centrally therethrough. First and second posts 184,186 project from a first surface of the base 180, opposite the hole 182 from one another. First and second pawl an~ns X88, 1.90 project from a second surface of the base 180, opposite the first surface, and extend inwardly from the periphery of the counting pawl 172 toward the central hole 182.
The counting pawl 172 is mounted within the counter housing 86, with the boss 88 of the upper support plate 80 projecting through the hole 180, and the first and second posts 184, 186 extending through the inboard and outboard slots 94, 96, respectively.
The inboard and outboard slots 94, 96 are preferably elongate and radiused, whereby the counting pawl 172 can rotate about the boss 88 through an arc of approximately 35 ° , The first post 184 protrudes through the inboard slot 94, and extends between the first and second dogs 46, 48 of the blade carrier 30. Clockwise (as indicated with reference to Fig. 6b) rotation of the cutting mechanism 12 through the syringe-cutting stroke brings the first post 184 into contact with the second dog 48, and causes the counting pawl 172 to rotate through an arc of approximately 35 ° about the boss S8 in a clockwise (as indicated in Pigs. Sa-b) direction. The second post 186 of the counting pawl 172 extends through the outboard slot 96 in the upper support plate 80, and projects into the slot 116 in the anti-reverse pawl 44 (see Fig. 6). As the counting pawl rotates through its arc of approximately 35 ° about the boss 88 in a clockwise (as indicated in Figs. 5a-b) direction, the second post 186 operates as an eccentric cam within the slot 116 to lift the tip 112 of the pawl 44 out of engagement with the teeth of the toothed ring 40, and permit the cutting mechanism 12 to return to its starting position. Upon return to the starting position, the first post 184 of the counting pawl 172 contacts the first dog 46 and rotates the counting pawl 172 about the boss 88 back through art arc of approximately 35 ° in the counterclockwise (CCW) direction.
The counting ratchet 174 preferably comprises a generally circular lower half comprising a plurality of ratchet teeth 200, and a centrally located hole (unshown).
The boss 88 of the upper support plate 80 extends into the centrally located hole in the bottom of the counting ratchet 174, permitting the counting ratchet 174 to rotate about the axis of the boss 88. In the preferred embodiment depicted in the figures, the counting ratchet 174 comprises twelve ratchet teeth 200, each tooth spanning approximately 30 ° of the circumference of the lower half of the counting ratchet. The number of ratchet teeth 200 on the counting ratchet 174 is preferably equal to the number of ratchet teeth 90 in the counter housing 86. Alternatively, the nuanber of ratchet teeth 200 can be an even multiple of the number of ratchet teeth 90.
Por example, in the depicted embodiment comprising twelve ratchet teeth 90, the number of ratchet teeth 200 can be twenty-four, thirty-six, and so on. The lower half of the counting ratchet 174 is mounted between the pawl arms 188, 199 of the counting pawl, with the tips of the pawl arms 188, 190 engaging the ratchet teeth 200.
An upper portion of the counting ratchet 174 preferably comprises at least one, and more preferably three, outwardly facing pawls 202. The pawls 202 engage the ratchet teeth 90 on the inner face of the counter housing 86 so that the counting ratchet 174 can rotate only in a clockwise direction, as indicated with reference to Fig. S.
Because each ratchet tooth 90 spans an arc of 30 °, in the depicted embodiment, clockwise rotation of the counting ratchet 174 by an increment of at least 30 °
advances the pawls 202 to the next set of ratchet teeth 90. The ratchet teeth 200 of the counting ratchet 174 cooperate with the pawl. arms I 88, 190 of the counting pawl 172, and the pawls 202 of the counting ratchet 174 cooperate with the ratchet teeth 90 on the inner face of the counter housing 86, so that clockwise rotation of the counting pawl 172 imparts like clockwise rotation to the counting ratchet 174, but counterclockwise rotation of the counting pawl I72 of 30°or nr~ore will index the pawl arms 188, 190 of the counting pawl 172 to a preceding set of ratchet teeth 200 of the counting ratchet 174. Because each syringe-cutting cycle causes the counting pawl I72 to cycle through an arc of approximately 35 °, first in the clockwise direction and then in the counterclockwise direction, each syringe-cutting cycle will advance the pawls 202 by one ratchet tooth 90 (30°) on the clockwise portion of the cutting cycle, and will index the pawl arms 188, 190 to a preceding set of ratchet teeth 200 on the counterclockwise portion of the cutting cycle. Thus, in the depicted embodiment wherein the counting ratchet 174 comprises twelve ratchet teeth 200, twelve syringe cutting cycles will result in a full turn of the counting ratchet 174. An eccentric boss 210 is preferably provided, projecting from the upper portion of the counting ratchet 174. The boss 210 is offset a distance from the axis of rotation of the counting ratchet 174 such that upon rotation of the counting ratchet 174, the boss 210 follows a circular, or orbital, path about the axis of rotation of the counting ratchet The orbital reducer 176 preferably comprises a generally circular disc-shaped body portion 220 having a plurality of equally spaced lobes 222 around its circumference. rn the depicted embodiment, ten semicircular lobes 222 are spaced about the circumference of the orbital reducer I76. The number of lobes 222 is selected to be less than, and most preferably one less than, the number of seats 92 in the counter housing 86. As seen best with reference to Fig. 8, the orbital reducer 176 preferably further comprises a hole 224, generally centrally located on a lower face of the body portion 220, and sized to engage the boss 210 projecting from the counting ratchet 176 with a running fit. The orbital reducer 176 is mounted in the counter housing 86, over the counting ratchet 176 with the boss 210 received in the hole in the lower face of the orbital reducer 176, and at least one lobe 222 seated in a seat 92 of the counter housing. Because of the engagement of the offset boss 210 within the hole in the lower face of the orbital reducer 176, each orbital path of the boss 210 imparted by a clockwise rotation of the counting ratchet 174 causes the orbital reducer 176 to traverse a clockwise orbital path about the inner circumference of the counter housing 86, as shown sequentially in Fig. 8, with successive lobes 222 engaging successive seats 92. Because there are fewer lobes 222 than seats 92, each clockwise orbit of the orbital reducer 176 about the center of the counter housing 86 causes the orbital reducer to rotate about its center in a counterclockwise direction, advancing rotationally by an angle corresponding to the number of lobes 222 less than the number of seats 92. For example, the orbital sequence depicted in Fig. 8 spans a single clockwise orbit of the orbital reducer 176, and the marked lobe 222' rotationally advances one seat 92 in the counterclockwise direction. Because there are ten lobes 222 and eleven seats 92 (i.e., one less lobe than seats)in the depicted embodiment, each clockwise orbit of the orbital reducer X76 causes the orbital reducer to rotationally advance in a counterclockwise direction by an angle corresponding to the arc spanned by one lobe, or 36° (360° about the circumference of the orbital reducer ten lobes = 36°). Thus, ten clockwise orbits of the orbital reducer 176 are required to advance the orbital reducer by ten lobes, resulting in one full counterclockwise rotation (360°) of the orbital reducer. Because twelve syringe cutting cycles result in a full turn of the counting ratchet 174, and correspondingly one orbit of the boss 210 and of the orbital reducer 176 within the counter housing 86, one-hundred-twenty ( 120) syringe cutting cycles result in a full rotation of the orbital reducer (ten orbits per rotarion x twelve cutting cycles per orbit = 120 cutting cycles per rotation). Of course, one of ordinary skill in the art will recognize that the number of cutting cycles per rotation can be varied by appropriate selection of the configuration of various components of the counting mechanism, including for example, the number of ratchet teeth 90 and concave seats 92 in the counter housing 86,~the number of ratchet teeth 200 on the counting ratchet 174, and/or the number of lobes 222 on the orbital reducer I76. Likewise, the directional configurations and rotational directions indicated herein are for purposes of example only, and one skilled in the art will recognize that the directional configurations and directions of rotation of the various components can be reversed, with the operation of the components relative to one another remaining the same.
The orbital reducer 176 preferably further comprises an upper surface 228 having at least one cutout portion, for cooperating with the locking slide I50 as part of the over811 prevention lockout mechanism. In the depicted embodiment, and with particular reference to Figs. 1, 4 and 5, two semi-chordal cutouts 230 are provided on the upper surface 228 of the orbital reducer 176. According to a preferred embodiment, the orbital reducer 176 is initially advanced, as shown in Fig.
4c, in the counterclockwise direction a rotational extent sufficient to permit the locking slide 150 to rest on the upper surface 228, without interaction with the cutouts 230. As the orbital reducer 176 rotates in the counterclockwise direction as a result of the syringe cutting and cycle counting operational sequence, the orbital reducer ultimately moves into the "lockout" position, as shown in Fig. 4d, wherein the end of the base 152 of the locking slide 150 aligns with the cutouts 230 in the orbital reducer 176.
The spring arm 156 biases the locking slide 150 toward clockwise rotation about the fulcrum defined by the point of contact with the slide support fin 108. Thus, when the orbital reducer 176 rotates into the lockout position and the severed syringe and needle assembly is removed from the syringe guides 130, 132, the end of the base 152 of the locking slide 150 drops into engagcment with the cutouts 230. Once engaged within the cutouts 230, the lockout slide 150 is prevented from movement toward the right (with reference to Fig. 4), thereby blocking pivotal movement of the syringe guide 132. and preventing insertion of additional syringe and needle assemblies. The extent of initial rotational advance of the orbital reducer 17b can be selected to provide a predetermined number of cutting cycles prior to activating the overfill prevention lockout mechanism. For example, for the above~described example embodiment requiring 120 cutting cycles per rotation of the orbital reducer, by initially advancing the orbital reducer a rotational extent corresponding to about twenty cutting cycles (approxirtaately 60°), the apparatus will be "lyre-.set" for 100 cutting cycles prior to actuation of the ove~ll prevention lockout mechanism.
The present invention optionally further comprises an indicator for indicating the number of cutting cycles remaining prior to actuation of the overfill prevention lockout mechanism, or alternatively for indicating the number of cutting cycles already performed. vVith reference to Pigs, 1, 2, 4 and 5, according to a preferred embodiment, the orbital reducer 176 Comprises a cross-Shaped actuator 240, having four blades at right angles to one another, projecting from the approximate center of its upper surface 228. ,An indicator dial 242 is preferably coupled to the actuator 240.
The indicator dial 242 preferably comprises a slotted circular coupling 244 wi,tla four slots spaced at 90° intervals for engaging the four blades of the cross-shaped actuator 240. and permittiztg azt a~ooiount of play between the actuator and the dial 242 sufficient to compensate for the orbital movement of the orbital reducer, while coupling the rotation of the orbital reducer to rotation of the indicator dial about a fixed axis of rotation.
The apparatus 10 of the present invention preferably further comprises a top cover 250. According to the depicted embodirxlent, and as seen best with reference to Figs. 1, 3 and 4, the top cover 250 comprises a generally oblotttg hollow shell adapted to house the components of the cutting raechanism rotationally coupled to the blade catxier 30. The top cover 250 preferably comprises one or more keys 252 for engaging the clips 106 of the upper support plate 80 to secure the cover 250 in place.
1fie cover Z50 preferably further comprises an entryway 254, adapted to receive and engage a needle and syringe assembly 14, generally aligned over the channel between the syringe guides 130. 132 and the duct 84. An opening 256 is p~t~eferably provided for receiving the indicator dial 242. Markings 258 arc preferably provided on the cover 250 and/or the indicator dial 242 for indicating the number of remaining uses or the number of prior uses. The markings can be visual, such as an arrow and/or numbering, and/or tactile, such as braille or other surface features. Zn the example embodiment requiring I20 cutting cycles per rotation of the orbital reducer, each cutting cycle advances the indicator dial by an increment of approximately 3 ° (360°
per rotation =120 cutting cycles per rotation= 3 ° per cutting cycle).
The apparatus 10 of the present invention enables a method of destructioa and disposal of syringe and needle assemblies 14, which will be described with particular reference to Figs. 2 and 3. The present invention is applicable to a variety of types of syringe and needle assemblies 14, and in example embodiments, is particularly adapted to use with integral needle, single use insulin syringes. It will be understood that the syringe and needle assembly 14 is a workpiece to ba operated upon by the apparatus 10 of the present invention, aztd does' not form a necessary element of the claimed invention. After use, the needle end of a syringe and needle assembly 14 is inserted into the entryway 254 of the apparatus 10. A slight amount of pressure will be felt by the user as the syringe and needle assenoibly 14 opens the syringe guides 130, I32 and passes through the channel 136 therebetween: ~'pon contacting the syringe stop 36, additional pressure is required on the plunger end of the syringe and needle assembly 14 to overcome the bias force applied by the spring anon 38, and move the syringe stop 36 from the first position (Fig. 7b) to the second position (Fig.
7c) against the mechanical stop. This serves to fully seat the plunger within the syringe body, and to unlock the cutting mechanism, as described above.
Substantial resistance to motion is encountered upoa the syringe atop 36 reaching the mcchtuiical stop, indicating that the syringe and needle assembly 14 is fully seated for putting.
Next, the user initiates the cutting cycle by twisting one portion of the apparatus comprising the top cover 250 and housed portions of the cutting mechanism through a cutting strolce> in a first direction relative to another portion of the apparatus comprising the housing 16 and blade Gamier 30. The apparatus is twisted in the fast direction, from a starting position (shown in Figs. 2a and 6a) toward a cutting position (shown in Fig. 2b). In the depicted embodiment, the first direcrion of rotation is clockwise when viewed from the and of the top cover 250 in the direction of indicating arrow A. The ratcheting action of the anti-reverse pawl 44 in cooperation with the teeth of the toothed ring 40 prevent reversing the twisting action until a full cutting stroke has been traversed in the first direction, thereby eliminating the possibility that the syringe ~d needle assembly 14 may be removed prior to complete detachment of its needle end. As the cutting mechanism traverses the cutting stroke, the syringe and nccdlc assembly 14, being offset from the axis of rotation, traverses an arcuate path, exiting the U-shaped lug 39 of the syringe stop 36, and intersecting the cuttaztg edge of the blade 34. The oblong shape of the top cover 250 provides the user with a degree of mechanical advantage in driving the syringe and needle assembly 14 through the blade 34 to sever the barrel of the syt~inge and the syringe plunger just above the attachment point of the needle. The cutting stroke preferably continues through an arc of approximately 100 °, as shown in Figs. 2b and 6b, ensuring that the entire syringe and needle assembly 14 has traversed the cutting edge of the blade 34, completely severing the detached portion 18 from the remainder of the syringe and needle assembly 14, Once the syringe and needle assembly 14 is clear of the U-shaped rug 39 the detached portion 18 of the syringe and needle assembly 14 is free to drop into tho contained volume of the housing 16 upon complete severing thereof. At the completion of the cutting stroke, the second dog 48 of the blade carnet 30 contacts the first post 184 of the counting pawl 172, and causes the counting pawl to rotate through a clockwise ate of approximately 35 °. As described above, rotations of tote counting pawl indexes the counting mechanism one increment, and causes the second post 1B6 of the counting pawl 172 to lift the tip 11Z of the pawl 44 out of engagement with the teeth of the toothed ring 40, thereby permitting the cutting mechanism 12 to be twisted along a return stroke in a second direction opposite the first direction and be returned to its starting position. Upon return to the starting position, the first post 184 of the counting pawl 172 contacts the first dog 46 of the blade carrier 30 and rotates the counting pawl 1?2 back through an arc of approximately 35 °
in the counterclockwise (CC'W) direction, advancing the pawl anus 188, 190 to a preceding set of ratchet teeth 200 on the counting ratchet 174, and returning the anti-reverse pawl 44 into engagement with the toothed ring 40. As shown in Fig. 2c, the detached portion 18 of the syringe and needle assembly 14 is collected for later disposal in the housing 16, and the remainder of the syringe and needle assembly 14 can be removed from the apparatus 10. At the completion of the return stroke, the syringe stop 36 returns to its first position (Fig. 7b), under the biasing influence of the spring arm 38, to prevent inadvertent operation of the device until another syringe and needle assembly 14 is inserted. The cutting cycle is then complete, and the apparatus is ready to receive and process another syringe and needle assembly. As described above, the overFlll prevention lockout mechanism permits a predetermined number of cutting cycles, preferably approximately 100, prior to disabling further use, thereby preventing overfilling and potential needle sticks that may result therefrom.
The disclosures of any publications referred to herein are hereby incorporated by reference in their entireties into this application in order to more fully describe the state of the art to which this invention pertains.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. For example, various alternate mechanical counting and lockout mechanisms, or electronic counting and lockout systems can be substituted for the above-described embodiments. Similarly, electronic indicator devices can be substituted for the above-described embodiments. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Background of the nvention Field of the Invention The present invention relates generally to personal medical devices, and more particularly to a device for the destruction and disposal of hypodermic needle syringes.
Description of Related Art The treatment of various medical conditions often requires the percutaneous injection of medicines by means of a hypodermic needle and syringe. For example, persons with diabetes commonly inject themselves with insulin on a periodic basis, using a disposable, single-use insulin syringe. After injection, the syringe must be properly and safely disposed of. The sharp needle of the syringe is typically contaminated with biologic fluids and/or medicines, and presents a significant health concern.
Thus, it is desirable that used needles be collected into a puncture-proof container for safe disposal.
In addition, it is desirable that used syringes be disabled to prevent their accidental re-use, or the intentional misuse of the syringe by illegal drug users.
Various "sharps containers" have been developed for the storage and disposal of used syringe and needle assemblies. These containers typically provide a storage volume surrounded by a puncture-resistant housing, and having a tamper-proof inlet to prevent removal of contents. Many such containers are designed to receive the entire needle and syringe assembly, and are intended for stationary use, such as on a countertop or shelf.
Such containers are typically too bulky fax convenient portable, personal use.
Also, containment of intact needle and syringe assemblies presents a potential fortheirremoval and re-use.
Several known containment devices enable the destruction of needle and syringe assemblies by severing, breaking, unthreading or otherwise detaching sharp and/or contaminated portions thereof, and storing the detached portions for disposal.
Certain disadvantages to known containment devices of this variety have been found to exist.
For example, overfilling of the containment chamber can result in protrusion of needle points, and potential injury may result. Premature removal of a needle and syringe assembly, before complete detachment of sharp and/or contaminated porrkions thereof, also presents a risk of needle stack by the partially detached portion.
Thus, it has been found that needs exist for an improved apparatus and method for disabling needle and syringe assemblies and storing sharp and/or contaminated portions thereof for disposal.
um ary~he Invention The present invention provides an improved apparatus and method for disabling needle and syringe assemblies and storing sharp and/or contaminated portions thereof for disposal, In preferred embodiments, the apparatus of the present invention is compact and easy to operate, thereby enabling convenient portable, personal use.
According to example embodiments described in greater detail herein, the apparatus and method of the present invention can incorporate a counter mechanism, and an overfill prevention mechanism to prevent overfilling by disabling further operation after a predetermined number of needle and syringe assemblies have been processed. Other example embodiments described in greater detail herein prevent premature syringe removal by the user prior to complete detachment of the needle end thereof. The apparatus and method of the present invention can be configured for use with a wide array of syringe and needle assemblies. In particular applications, the apparatus and method of the present invention are adapted for use with single-use, integral needle insulin syringes such as those manufactured by Beckton Dickinson Co, or the Monoject division of Sherwood Medical Co.
1n accordance with the purposes of the invention, as embodied and broadly described herein, the invention in one aspect relates to an apparatus for disabling a syringe and needle assembly. The apparatus preferably comprises a first portion comprising a blade having a cutting edge, and a second portion, pivotally connected to the first portion, and comprising means for engaging a syringe~and needle assembly, whereby pivotal movement of the second portion relative to the first portion~causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly.
In another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and a counting mechanism for counting a number of cutting cycles effected by said apparatus.
In another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe, and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and an anti-reverse mechanism for preventing premature removal of a syringe and needle assembly prior to complete detachment of at least a needle porkion thereof.
rn another aspect, the invention relates to an apparatus for detaching and disposing of a portion of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly, and an overfill prevention mechanism for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus, In another aspect, the invention relates to an apparatus for detaching and disposing of a portion ~ of a syringe and needle assembly, the apparatus preferably comprising a cutting blade for severing a poztion of a syringe and needle assembly to detach at least a needle portion thereof, a receptacle for receiving the detached portion of a syringe and needle assembly. and a Iockout mechanism for pr,cvendng operation of said apparatus prior to loading a syringe and needle assembly therein.
In another aspect, the invention relates to an apparatus for disabling a syringe and needle assembly, the apparatus preferably comprising a first portion comprising a blade having a cutting edge, and a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle asserxibly, wvhereby pivotal z~aovement of said second portion rclaliuc to said first portion causes the syangc and needle assembly to traverse a path intersecting the cutting edge of tkxe blade to sever and detach a portion of the syringe and needle assembly. The apparatus preferably further comprises a counting mechanism for counting a number of cutting cycles effected by said apparatus. each cutting cycle comprising a cutting stroke comprising pivotal anovement of said second portion relaCive to sand first portion in a first rotational direction, and a return stmke comprising pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction, wherein said counting mechanism is incrementally advanced by movement of a counting pawl actuated by contact with said first portion. The apparatus preferably further comprises an anti-xeversc mechanism for permitting pivotal movement of said second portion relative to said first portion in the first rotational direction only until completion of the cutting stroke, wherein rotation of said counting pawl disengages the anti-reverse mechanism upon completion of the cutting stroke.
Additional features and advantages of the invention will be set forth in part in the detailed description, including the drawing figures, which follows, and in part will be obvious from the description,-or may be learned by practice of the invention.
The advantages of the invention will be realized and attained by means of the elements and combinations parkicularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.
Brief Descriution of the Draw~fn~~r~
Pigure 1 shows an exploded perspective view of an apparatus according to a preferred form of the present invention.
Figures 2a-2c show perspective views of the apparatus of Fig. 1, assembled and demonstrating a cutting sequence according to a preferred method of operation thereof.
Figures 3a and 3b show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 4a-4f show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures Sa-Sc show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 6a and 6b show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figures 7a.:7c show detailed sectional views of portions of the apparatus depicted in Fig. 1.
Figure 8 shows an orbital sequence of a portion of a counting mechanism according to a preferred embodiment of the present invention.
Detai ed Descrintinn o~f Preferred E bod im r.t~
The present invention may be understood more readily by reference to the following detailed description of preferred embodiments of the invention, including the appended drawing f~gures referred to herein, and the examples provided thez~ein. It is to be understood that this invention 1s not limited to the specific eznbodimcnts shown or described, which are intended as exemplary only, and not limiting of the invention as defined by the appended claims. It must also be noted that, as used in the spcciftcation and the appended clainns, the singular forms "a," "an" and "the"
include plural referents unless the context clearly dictates otherwise, lZanges may be expressed herein as from "about" or "approximately" one particular value and/or to "about"or "approximately" another particular value. When such a range is exprosscd, another embodiment znucludes from the one particular value andlvr to the other particular value. Similarly, when values are expressed as spproxiixtations, by use of the antecedent "about," or "approximately" it will be understood that the particular value forms another eratbodiment.
Referring now in detail to the drawing figures, wherein like reference numerals represent like pacts throughout, an apparatus 10 according to a preferred form of the present invention generally comprises a cutting mechanism 12 for disabling a syringe and needle assembly 14, and a housing 16 For containing detached portions 18 of disabled syringe and aeedle assemblies. The housing I6 preferably comprises a shell of plastic or other substantially puncture-resistant material enclosing a contained volume sufficient to contain a predetermined quantity of detached portions 18 of disabled syringe and needle assemblies. Por cxaz~aple, in an example embodiment of the present invention, the contained volume is sufficient to contain at least one hundred detached portions 18 of disabled single-use, integral needle Insulin syringes. 'The housing 16 preferably includes a mouth 20 adapted to engage a porkion of the cutting mcchartism 12 and receive detached portions 18 of disabled syringe and needle assemblies from the cutting mechatusmo~ 12. In preferred form, the apparatus of the present invention is of a readily portable size and shape enabling a user to carry the apparatus in a pocket or purse.
The cutting mechanism 12 is preferably adapted to engage the mouth 20 of the housing 16, and to engage and detach a portion of a syringe and needle assembly and deliver the detached portion to the contained volume of the housing. The cutting mechanism 12 optionally includes one or more sub-assemblies such as, for example, for counting the number of syringe and needle assemblies processed, and indicating the number of uses remaining; for preventing withdrawal of a syringe and needle assembly once engaged in the cutting mechanism; and/or for preventing overfilling by disabling the apparatus after a predetermined number of uses.
An example embodiment of the cutting mechanism 12 will be described with reference to the drawing figures. As seen best with reference to Fig. 1, the cutting mechanism 12 comprises a blade carrier 30, also shown in Fig. 7. The blade carrier 30 preferably includes a shoulder 32 projecting from a first face thereof, and adapted to engage the mouth 20 of the housing 16, whereby portions of syringe and needle assemblies detached by the cutting mechanism 12 are deposited in the contained volume of the housing 16. The blade carrier 30 preferably further comprises one or more slots, tabs or other engagement features for retaining a cutting blade 34, such as a razor or knife blade, in place over the mouth 20 of the housing 16. The blade 34 is preferably steel or other material capable of retaining a sharp edge. The remaining portions of the cutting mechanism are preferably formed of plastic, as by injection molding.
The blade carrier 30, according to the depicted embodiment, preferably further comprises one or more slots, tabs or other engagement features for slidably engaging a syringe stop 36. The syringe stop 36 limits the travel of the syringe and needle assembly 14 upon insertion, to properly position the syringe relative to the cutting blade 34 to sever the syringe and needle assembly 14 just above the needle.
The syringe stop 36 also functions to prevent operation of the apparatus when no syringe and needle assembly 14 is inserted therein for destruction. As seen with reference to Fig. 7, in the depicted embodiment, the syringe stop 36 includes a pair of ribs 37 which slide in the direction of insertion of the syringe and needle assembly 14 within cooperating grooves in the blade carrier 30, permitting the syringe stop 36 to travel between a first position '(shown in Fig. 7b) and a second position (shown in Fig. 7e).
Thb blade carrier 30 preferably further comprises a resilient spring area 38, for contacting a portion of the syringe stop 36 and biasing the syringe stop toward the first position. Ih the first position, a portion of the syringe stop projects outwardly of the blade carrier to prevent rotation and operation of the apparatus until the syringe stop is moved into the second position upon insertion of a syringe and needle assembly 14.
In this manner, the syringe stop functions as a lockout mechanism to prevent operation of the cutting mechanism without first loading a syringe and needle assembly. A mechanical stop, such as a termination or discontinuity in the grooves of the blade cazrier 30, limits the travel of the syringe stop at tha second position to prevent overstressing of the spring arm 38, and to accurately and consistently position the syringe and needle assembly 14 relative to the cutting blade 34. The syringe stop preferably further comprises a generally U-shaped lug 39 having interior walls converging from a larger dimension at a first end to a smaller dimension at a second end. The larger dimension is configured to freely pass a syringe and needle assembly I4 of standard diameter, whe~ceas the smaher dimension prevents passage of the syringe and needle assembly 14. The open end of the U-shaped lug 39 is preferably flared to permit a syringe and needle assembly inserted therein to readily be removed therefrom upon rotational actuation of the apparatus as will be described in greater detail below.
In the depicted embodiment, the blade carrier 30 preferably further comprises a toothed ring 40 projecting from a surface 41 opposite the shoulder 32. The toothed ring 40 preferably comprises a generally annular projection surrounding an opening 42 for passing detached portions 18 of syringe and needle assemblies 14 into the housing 16. The toothed ring 40 cooperates with an anti,-reverse pawl 44. to prevent reverse operation of the apparatus 10 after processing of a syringe and needle assembly 14 has begun, thereby requiring completion of the processing sequence and preventing premature withdrawal of the syringe and needle assembly 14, as described in greater detail below. A first dog 46 and a second dog 48 are preferably provided, offset approximately 90° circumferentially from one another and extending radially inward from the toothed ring 40, for indexing the counter mechanism, and for lifting the anti-reverse pawl 44. out of engagement with the toothed ring 40 at the end of a processing sequence to allow the apparatus to return to its stetting configuration.
The cutting mechanism of the depicted embodiment preferably further comprises a lower support plate 60, rotationally mounted to the blade cagier 30. The lower support plate 60 is preferably formed from two half plates 60a. 60b, each comprising a generally semicircular cutout 62 adapted to engage a circumferential slotted portion about the toothed ring 40, and rotationally couple the blade carrier to the remainder of the cutting mechanism I2. >jn this manner, the housing 16 and blade carrier 30 comprise a first porkion of the apparatus, and the remainder of the cutting mechanism forms a second portion of the apparatus, whereby the second portion is pivotally connected to the first portion about an axis of rotation extending generally through the center of the toothed ring 40. Each half plate 60a, 60b preferably comprises intcx~cngaging tabs and slots 64, enabling engagement with one another about the toothed ring 40 whereby a pivot surface 66 of the lower support plate 60 confronts the surface 41 of the blade carver 30. ~'he lower support plate 60 preferably comprises one or more resilient clips 68, or other means for engaging an upper support plate described in greater detail below.
The cutting mechanism 12 preferably further comprises an upper support plate 80, mounted between the half plates 60a, 60b of the lower support plate opposite the pivot surface 66. As seen best with reference to Figs, 1 and 5, the upper support plate 80 preferably coztxprises a base platform 82 with a duct 84 providing an opening For engaging a syringe and needle assembly and permitting passage of a portion of flee syringe and needle assembly therethrough. The duct 84 is offset from the axis of rotation between the first and second portions of the apparatus, whereby twisting of the apparatus through a cutting sequence, as described below, causes the syringe and needle assembly to traverse an arcuate path intersecting the cutting edge of the blade 34. The upper support plate 80 preferably further comprises a generally cylindrical counter housing 86 arranged adjacent a first end thereof and having a central longitudinal axis generally perpendicular to the plane of the base platform 82. A
counter-mounting boss 88 is preferably provided, extending generally perpendicularly from the base platform 82, along the central longitudinal axis of the cylindrical counter housing 86. The boss 88 can be generally cross-shaped in cross-section, as depicted, or can be of circular or other cross-sectional geometry as will permit rotation thereabout by elements of the counter mechanism as will be described in greater detail below. A portion of the inner wall of the generally cylindrical counter housing 86 proximal the base platform 82 is provided with a plurality of ratchet teeth 90. 1fie number of ratchet teeth 90 provided will factor into the counting and overFll-prevention lockout systems, as described in greater detail below. In a preferred embodiment, twelve ratchet teeth are provided, each spanning approximately 30° of the inner circumference of the counter housing 86. A portion of the inner wall of the generally cylindrical counter housing 86 distal the base platform 82 is provided with a plurality of concave seats 92. The number of concave seats 92 provided will also factor into the counting and overfill-prevention lockout systems, as described in greater detail below. Tn a preferred embodiment, eleven concave seats are provided, each spanning approximately 33 ° of the inner circumference of the counter housing 86. A pair of elongate slots, comprising an inboard slot 94 and an outboard slot 96 are preferably provided through a floor portion of the cylindrical counter housing 86.
First and second support ribs 98,100 are preferably provided, extending generally perpendicularly to the base platform 82 of the upper support plate 80 oil opposite sides of the duct 84 for supporting syringe guides described below. The edge of each support rib 98, 100 distal the base platform 82 is preferably provided with a spaced pair of grooves 102, 104. Corresponding grooves 102A and 1028 of the first and second support ribs 98, 100, respectively, are aligned opposite the duct 84 from one another; and corresponding grooves 104A and 104B of the first and second support ribs 98, 100, respectively, are also aligned opposite the duct 84 from one another.
One or more resilient clips 10d or other retaining means are preferably provided for attaching the upper support plate 80 to other components of the cutting mechanism, as described below. A slide support fin 108 is preferably provided, projecting fmm the base platform 82 opposite the support ribs 98, 100 from the counter housing 86.
The apparatus 10 optionally provides an anti-reverse mechanism, which is described with particular reference to a preferred embodiment shown in Figs. 1 and 6.
The anti-reverse mechanism preferably comprises the anti-reverse pawl 44 in cooperation with the teeth of the toothed ring 40 of the blade carrier 30, in the fashion of a ratchet. The anti-reverse mechanism prevents incomplete cycling of the cutting mechanism 12, requiring operation through the entire cutting cycle before returning to the start position, thereby preventing premature removal of a syringe and needle assembly before complete detachment of sharp or potentially contaminated portions thereof. The anti-reverse pawl 44 is positioned between the counter housing 86 of the upper support plate 80 and the Iower support plate 60. A small boss 110 projecting from the pawl 44 engages a cooperating recess or hole in the lower support plate 60, thereby permitting the pawl to pivot sufficiently to engage (Fig. 6a) and disengage (Fig. 6b) a tip portion 112 of the pawl 44 with teeth of the toothed ring 40 of the blade carrier 30. A tail portion 114 of the pawl 44 is anchored between the counter housing 86 of the upper support plate 80 and the lower support plate 60, and acts as a spring to bias the tip portion I 12 toward engagement with the teeth of the toothed ring 40.
When the tip portion 112 of the pawl 44 is engaged with the teeth of the toothed ring 40 of the blade Gamier 30, the cutting mechanism 12 can be rotated relative to the housing 16 only in the clockwise (CW) direction {as indicated with reference to Fig.
6b). An elongated slot 116 is provided in the pawl 44 between the boss 110 and the tip portion 112 to receive a second past of the counting pawl, described below, to lift the pawl tip 112 free of the teeth of the toothed ring 40 at the end of the cutting stroke so that the cutting mechanism 12 can thereafter be returned to the starting position.
The apparatus 10 optionally further provides an overfill prevention lockout mechanism, described according to a preferred embodiment with particular reference to Figs. 1, 3 and 4. A pair of syringe gwides 130, I32 are mounted in the grooves 102, 104, between the support ribs 98, 100, and over the duct 84 leading to the contained volume of the housing 16. Each syringe guide 130, 132 comprises a pair of outwardly projecting fingers 134 at a first end thereof, adapted to be pivotally mounted within corresponding grooves i02, 104. The body of each syringe guide 130, 132 depends from the fingers 134 toward the duct 84. Confronting faces of each syringe guide 130, 132 are provided with a semicircular groove, thereby forming a circular channel 136 between the syringe guides 130, 132 having a diameter permitting sliding engagement of a syringe and needle assembly of the type to be processed. The exterior face of each syringe guide 130, 132, opposite the grooved side, can be provided with a knob 138 for contacting adjacent components of the overfill prevention lockout mechanism, for accurate positioning and alignment.
The overfill prevention mechanism preferably further comprises a locking slide 154, depicted in preferred form by Figs. 1 and 4. The locking slide 150 preferably comprises a base 152 having a first end slidably supported on the slide support fin 108 of the upper support plate and a second end supported on an orbital reducer component of the counting mechanism described below. A portion of the base is removed to provide a clearance opening 154 for the support ribs 98, 100 and the syringe guides 130,132 to pass through. The locking slide preferably further comprises a spring arm 156 having a first end extending from the first end of the base 152, a looped medial portion, and a free end extending through the clearance opening 154. A positioning flange 158 preferably extends from the base 152, opposite the spring arm 156 and adjacent the first end of the locking slide 150, to limit travel of the locking slide 150 along the slide support 8n 108 towards the left (with reference to Fig. 4) to the position shown in Fig. 4b. When no syringe and needle assembly is inserted in the apparatus, the spring arm 156 contacts the syringe guide 130 and biases it toward syringe guide 132 to close the channel 136 and prevent escape of detached portions of syringe and needle assemblies from the contained volume of the housing 16. As a syringe and needle assembly 14 is introduced into the apparatus (Fig.
4b), the syringe guides 130, 132 open to pass the syringe and needle assembly 14 through the channel 136. Hy action of opening the syringe guides 130, 132, the locking slide 150 is contacted by the syzinge guide 132 and forced toward the right (Fig.
4a). In normal operation, the locking slide 150 is free to slide to the right, as described, over the surface of the orbital reducer. After cycling through a predetermined number of cutting cycles, and as described in greater detail below, the orbital reducer blocks sliding of the locking slide 150 to prevent introduction of additional syringe and needle assemblies.
The cutting mechanism 12 of the present invention optionally further comprises a counting mechanism 170, shown according to a preferred form in Figs. 1, 4 and 5. The counting mechanism 170 preferably comprises a counting pawl 172, a counting ratchet 174, and an orbital reducer 176, adapted to cooperate with and be received Within the counter housing 86 of the upper support plate 80. The counting mechanism 170 cooperates with the locking slide 150 and the syringe guides 130, I32, as described above, as part of the overfill prevention lockout mechanism;
and cooperates with an indicator, described below, to provide the user an indication of the number of cutting cycles remaining for use.
The counting pawl 172 preferably comprises a generally symmetrical component having a base 180 with a hole 182 extending generally centrally therethrough. First and second posts 184,186 project from a first surface of the base 180, opposite the hole 182 from one another. First and second pawl an~ns X88, 1.90 project from a second surface of the base 180, opposite the first surface, and extend inwardly from the periphery of the counting pawl 172 toward the central hole 182.
The counting pawl 172 is mounted within the counter housing 86, with the boss 88 of the upper support plate 80 projecting through the hole 180, and the first and second posts 184, 186 extending through the inboard and outboard slots 94, 96, respectively.
The inboard and outboard slots 94, 96 are preferably elongate and radiused, whereby the counting pawl 172 can rotate about the boss 88 through an arc of approximately 35 ° , The first post 184 protrudes through the inboard slot 94, and extends between the first and second dogs 46, 48 of the blade carrier 30. Clockwise (as indicated with reference to Fig. 6b) rotation of the cutting mechanism 12 through the syringe-cutting stroke brings the first post 184 into contact with the second dog 48, and causes the counting pawl 172 to rotate through an arc of approximately 35 ° about the boss S8 in a clockwise (as indicated in Pigs. Sa-b) direction. The second post 186 of the counting pawl 172 extends through the outboard slot 96 in the upper support plate 80, and projects into the slot 116 in the anti-reverse pawl 44 (see Fig. 6). As the counting pawl rotates through its arc of approximately 35 ° about the boss 88 in a clockwise (as indicated in Figs. 5a-b) direction, the second post 186 operates as an eccentric cam within the slot 116 to lift the tip 112 of the pawl 44 out of engagement with the teeth of the toothed ring 40, and permit the cutting mechanism 12 to return to its starting position. Upon return to the starting position, the first post 184 of the counting pawl 172 contacts the first dog 46 and rotates the counting pawl 172 about the boss 88 back through art arc of approximately 35 ° in the counterclockwise (CCW) direction.
The counting ratchet 174 preferably comprises a generally circular lower half comprising a plurality of ratchet teeth 200, and a centrally located hole (unshown).
The boss 88 of the upper support plate 80 extends into the centrally located hole in the bottom of the counting ratchet 174, permitting the counting ratchet 174 to rotate about the axis of the boss 88. In the preferred embodiment depicted in the figures, the counting ratchet 174 comprises twelve ratchet teeth 200, each tooth spanning approximately 30 ° of the circumference of the lower half of the counting ratchet. The number of ratchet teeth 200 on the counting ratchet 174 is preferably equal to the number of ratchet teeth 90 in the counter housing 86. Alternatively, the nuanber of ratchet teeth 200 can be an even multiple of the number of ratchet teeth 90.
Por example, in the depicted embodiment comprising twelve ratchet teeth 90, the number of ratchet teeth 200 can be twenty-four, thirty-six, and so on. The lower half of the counting ratchet 174 is mounted between the pawl arms 188, 199 of the counting pawl, with the tips of the pawl arms 188, 190 engaging the ratchet teeth 200.
An upper portion of the counting ratchet 174 preferably comprises at least one, and more preferably three, outwardly facing pawls 202. The pawls 202 engage the ratchet teeth 90 on the inner face of the counter housing 86 so that the counting ratchet 174 can rotate only in a clockwise direction, as indicated with reference to Fig. S.
Because each ratchet tooth 90 spans an arc of 30 °, in the depicted embodiment, clockwise rotation of the counting ratchet 174 by an increment of at least 30 °
advances the pawls 202 to the next set of ratchet teeth 90. The ratchet teeth 200 of the counting ratchet 174 cooperate with the pawl. arms I 88, 190 of the counting pawl 172, and the pawls 202 of the counting ratchet 174 cooperate with the ratchet teeth 90 on the inner face of the counter housing 86, so that clockwise rotation of the counting pawl 172 imparts like clockwise rotation to the counting ratchet 174, but counterclockwise rotation of the counting pawl I72 of 30°or nr~ore will index the pawl arms 188, 190 of the counting pawl 172 to a preceding set of ratchet teeth 200 of the counting ratchet 174. Because each syringe-cutting cycle causes the counting pawl I72 to cycle through an arc of approximately 35 °, first in the clockwise direction and then in the counterclockwise direction, each syringe-cutting cycle will advance the pawls 202 by one ratchet tooth 90 (30°) on the clockwise portion of the cutting cycle, and will index the pawl arms 188, 190 to a preceding set of ratchet teeth 200 on the counterclockwise portion of the cutting cycle. Thus, in the depicted embodiment wherein the counting ratchet 174 comprises twelve ratchet teeth 200, twelve syringe cutting cycles will result in a full turn of the counting ratchet 174. An eccentric boss 210 is preferably provided, projecting from the upper portion of the counting ratchet 174. The boss 210 is offset a distance from the axis of rotation of the counting ratchet 174 such that upon rotation of the counting ratchet 174, the boss 210 follows a circular, or orbital, path about the axis of rotation of the counting ratchet The orbital reducer 176 preferably comprises a generally circular disc-shaped body portion 220 having a plurality of equally spaced lobes 222 around its circumference. rn the depicted embodiment, ten semicircular lobes 222 are spaced about the circumference of the orbital reducer I76. The number of lobes 222 is selected to be less than, and most preferably one less than, the number of seats 92 in the counter housing 86. As seen best with reference to Fig. 8, the orbital reducer 176 preferably further comprises a hole 224, generally centrally located on a lower face of the body portion 220, and sized to engage the boss 210 projecting from the counting ratchet 176 with a running fit. The orbital reducer 176 is mounted in the counter housing 86, over the counting ratchet 176 with the boss 210 received in the hole in the lower face of the orbital reducer 176, and at least one lobe 222 seated in a seat 92 of the counter housing. Because of the engagement of the offset boss 210 within the hole in the lower face of the orbital reducer 176, each orbital path of the boss 210 imparted by a clockwise rotation of the counting ratchet 174 causes the orbital reducer 176 to traverse a clockwise orbital path about the inner circumference of the counter housing 86, as shown sequentially in Fig. 8, with successive lobes 222 engaging successive seats 92. Because there are fewer lobes 222 than seats 92, each clockwise orbit of the orbital reducer 176 about the center of the counter housing 86 causes the orbital reducer to rotate about its center in a counterclockwise direction, advancing rotationally by an angle corresponding to the number of lobes 222 less than the number of seats 92. For example, the orbital sequence depicted in Fig. 8 spans a single clockwise orbit of the orbital reducer 176, and the marked lobe 222' rotationally advances one seat 92 in the counterclockwise direction. Because there are ten lobes 222 and eleven seats 92 (i.e., one less lobe than seats)in the depicted embodiment, each clockwise orbit of the orbital reducer X76 causes the orbital reducer to rotationally advance in a counterclockwise direction by an angle corresponding to the arc spanned by one lobe, or 36° (360° about the circumference of the orbital reducer ten lobes = 36°). Thus, ten clockwise orbits of the orbital reducer 176 are required to advance the orbital reducer by ten lobes, resulting in one full counterclockwise rotation (360°) of the orbital reducer. Because twelve syringe cutting cycles result in a full turn of the counting ratchet 174, and correspondingly one orbit of the boss 210 and of the orbital reducer 176 within the counter housing 86, one-hundred-twenty ( 120) syringe cutting cycles result in a full rotation of the orbital reducer (ten orbits per rotarion x twelve cutting cycles per orbit = 120 cutting cycles per rotation). Of course, one of ordinary skill in the art will recognize that the number of cutting cycles per rotation can be varied by appropriate selection of the configuration of various components of the counting mechanism, including for example, the number of ratchet teeth 90 and concave seats 92 in the counter housing 86,~the number of ratchet teeth 200 on the counting ratchet 174, and/or the number of lobes 222 on the orbital reducer I76. Likewise, the directional configurations and rotational directions indicated herein are for purposes of example only, and one skilled in the art will recognize that the directional configurations and directions of rotation of the various components can be reversed, with the operation of the components relative to one another remaining the same.
The orbital reducer 176 preferably further comprises an upper surface 228 having at least one cutout portion, for cooperating with the locking slide I50 as part of the over811 prevention lockout mechanism. In the depicted embodiment, and with particular reference to Figs. 1, 4 and 5, two semi-chordal cutouts 230 are provided on the upper surface 228 of the orbital reducer 176. According to a preferred embodiment, the orbital reducer 176 is initially advanced, as shown in Fig.
4c, in the counterclockwise direction a rotational extent sufficient to permit the locking slide 150 to rest on the upper surface 228, without interaction with the cutouts 230. As the orbital reducer 176 rotates in the counterclockwise direction as a result of the syringe cutting and cycle counting operational sequence, the orbital reducer ultimately moves into the "lockout" position, as shown in Fig. 4d, wherein the end of the base 152 of the locking slide 150 aligns with the cutouts 230 in the orbital reducer 176.
The spring arm 156 biases the locking slide 150 toward clockwise rotation about the fulcrum defined by the point of contact with the slide support fin 108. Thus, when the orbital reducer 176 rotates into the lockout position and the severed syringe and needle assembly is removed from the syringe guides 130, 132, the end of the base 152 of the locking slide 150 drops into engagcment with the cutouts 230. Once engaged within the cutouts 230, the lockout slide 150 is prevented from movement toward the right (with reference to Fig. 4), thereby blocking pivotal movement of the syringe guide 132. and preventing insertion of additional syringe and needle assemblies. The extent of initial rotational advance of the orbital reducer 17b can be selected to provide a predetermined number of cutting cycles prior to activating the overfill prevention lockout mechanism. For example, for the above~described example embodiment requiring 120 cutting cycles per rotation of the orbital reducer, by initially advancing the orbital reducer a rotational extent corresponding to about twenty cutting cycles (approxirtaately 60°), the apparatus will be "lyre-.set" for 100 cutting cycles prior to actuation of the ove~ll prevention lockout mechanism.
The present invention optionally further comprises an indicator for indicating the number of cutting cycles remaining prior to actuation of the overfill prevention lockout mechanism, or alternatively for indicating the number of cutting cycles already performed. vVith reference to Pigs, 1, 2, 4 and 5, according to a preferred embodiment, the orbital reducer 176 Comprises a cross-Shaped actuator 240, having four blades at right angles to one another, projecting from the approximate center of its upper surface 228. ,An indicator dial 242 is preferably coupled to the actuator 240.
The indicator dial 242 preferably comprises a slotted circular coupling 244 wi,tla four slots spaced at 90° intervals for engaging the four blades of the cross-shaped actuator 240. and permittiztg azt a~ooiount of play between the actuator and the dial 242 sufficient to compensate for the orbital movement of the orbital reducer, while coupling the rotation of the orbital reducer to rotation of the indicator dial about a fixed axis of rotation.
The apparatus 10 of the present invention preferably further comprises a top cover 250. According to the depicted embodirxlent, and as seen best with reference to Figs. 1, 3 and 4, the top cover 250 comprises a generally oblotttg hollow shell adapted to house the components of the cutting raechanism rotationally coupled to the blade catxier 30. The top cover 250 preferably comprises one or more keys 252 for engaging the clips 106 of the upper support plate 80 to secure the cover 250 in place.
1fie cover Z50 preferably further comprises an entryway 254, adapted to receive and engage a needle and syringe assembly 14, generally aligned over the channel between the syringe guides 130. 132 and the duct 84. An opening 256 is p~t~eferably provided for receiving the indicator dial 242. Markings 258 arc preferably provided on the cover 250 and/or the indicator dial 242 for indicating the number of remaining uses or the number of prior uses. The markings can be visual, such as an arrow and/or numbering, and/or tactile, such as braille or other surface features. Zn the example embodiment requiring I20 cutting cycles per rotation of the orbital reducer, each cutting cycle advances the indicator dial by an increment of approximately 3 ° (360°
per rotation =120 cutting cycles per rotation= 3 ° per cutting cycle).
The apparatus 10 of the present invention enables a method of destructioa and disposal of syringe and needle assemblies 14, which will be described with particular reference to Figs. 2 and 3. The present invention is applicable to a variety of types of syringe and needle assemblies 14, and in example embodiments, is particularly adapted to use with integral needle, single use insulin syringes. It will be understood that the syringe and needle assembly 14 is a workpiece to ba operated upon by the apparatus 10 of the present invention, aztd does' not form a necessary element of the claimed invention. After use, the needle end of a syringe and needle assembly 14 is inserted into the entryway 254 of the apparatus 10. A slight amount of pressure will be felt by the user as the syringe and needle assenoibly 14 opens the syringe guides 130, I32 and passes through the channel 136 therebetween: ~'pon contacting the syringe stop 36, additional pressure is required on the plunger end of the syringe and needle assembly 14 to overcome the bias force applied by the spring anon 38, and move the syringe stop 36 from the first position (Fig. 7b) to the second position (Fig.
7c) against the mechanical stop. This serves to fully seat the plunger within the syringe body, and to unlock the cutting mechanism, as described above.
Substantial resistance to motion is encountered upoa the syringe atop 36 reaching the mcchtuiical stop, indicating that the syringe and needle assembly 14 is fully seated for putting.
Next, the user initiates the cutting cycle by twisting one portion of the apparatus comprising the top cover 250 and housed portions of the cutting mechanism through a cutting strolce> in a first direction relative to another portion of the apparatus comprising the housing 16 and blade Gamier 30. The apparatus is twisted in the fast direction, from a starting position (shown in Figs. 2a and 6a) toward a cutting position (shown in Fig. 2b). In the depicted embodiment, the first direcrion of rotation is clockwise when viewed from the and of the top cover 250 in the direction of indicating arrow A. The ratcheting action of the anti-reverse pawl 44 in cooperation with the teeth of the toothed ring 40 prevent reversing the twisting action until a full cutting stroke has been traversed in the first direction, thereby eliminating the possibility that the syringe ~d needle assembly 14 may be removed prior to complete detachment of its needle end. As the cutting mechanism traverses the cutting stroke, the syringe and nccdlc assembly 14, being offset from the axis of rotation, traverses an arcuate path, exiting the U-shaped lug 39 of the syringe stop 36, and intersecting the cuttaztg edge of the blade 34. The oblong shape of the top cover 250 provides the user with a degree of mechanical advantage in driving the syringe and needle assembly 14 through the blade 34 to sever the barrel of the syt~inge and the syringe plunger just above the attachment point of the needle. The cutting stroke preferably continues through an arc of approximately 100 °, as shown in Figs. 2b and 6b, ensuring that the entire syringe and needle assembly 14 has traversed the cutting edge of the blade 34, completely severing the detached portion 18 from the remainder of the syringe and needle assembly 14, Once the syringe and needle assembly 14 is clear of the U-shaped rug 39 the detached portion 18 of the syringe and needle assembly 14 is free to drop into tho contained volume of the housing 16 upon complete severing thereof. At the completion of the cutting stroke, the second dog 48 of the blade carnet 30 contacts the first post 184 of the counting pawl 172, and causes the counting pawl to rotate through a clockwise ate of approximately 35 °. As described above, rotations of tote counting pawl indexes the counting mechanism one increment, and causes the second post 1B6 of the counting pawl 172 to lift the tip 11Z of the pawl 44 out of engagement with the teeth of the toothed ring 40, thereby permitting the cutting mechanism 12 to be twisted along a return stroke in a second direction opposite the first direction and be returned to its starting position. Upon return to the starting position, the first post 184 of the counting pawl 172 contacts the first dog 46 of the blade carrier 30 and rotates the counting pawl 1?2 back through an arc of approximately 35 °
in the counterclockwise (CC'W) direction, advancing the pawl anus 188, 190 to a preceding set of ratchet teeth 200 on the counting ratchet 174, and returning the anti-reverse pawl 44 into engagement with the toothed ring 40. As shown in Fig. 2c, the detached portion 18 of the syringe and needle assembly 14 is collected for later disposal in the housing 16, and the remainder of the syringe and needle assembly 14 can be removed from the apparatus 10. At the completion of the return stroke, the syringe stop 36 returns to its first position (Fig. 7b), under the biasing influence of the spring arm 38, to prevent inadvertent operation of the device until another syringe and needle assembly 14 is inserted. The cutting cycle is then complete, and the apparatus is ready to receive and process another syringe and needle assembly. As described above, the overFlll prevention lockout mechanism permits a predetermined number of cutting cycles, preferably approximately 100, prior to disabling further use, thereby preventing overfilling and potential needle sticks that may result therefrom.
The disclosures of any publications referred to herein are hereby incorporated by reference in their entireties into this application in order to more fully describe the state of the art to which this invention pertains.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. For example, various alternate mechanical counting and lockout mechanisms, or electronic counting and lockout systems can be substituted for the above-described embodiments. Similarly, electronic indicator devices can be substituted for the above-described embodiments. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Claims (24)
1. An apparatus for disabling a syringe and needle assembly, said apparatus comprising:
(a) a first portion comprising a blade having a cutting edge: and (b) a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle assembly, whereby pivotal movement of said second portion relative to said first portion causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly.
(a) a first portion comprising a blade having a cutting edge: and (b) a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle assembly, whereby pivotal movement of said second portion relative to said first portion causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly.
2. The apparatus of Claim 1, wherein said first portion further comprises a housing bounding a contained volume for collecting detached portions of syringe and needle assemblies.
3. The apparatus of Claim 1, further comprising a lockout mechanism to prevent pivotal movement of said second portion relative to said Fast portion prior to loading the apparatus with a syringe and needle assembly.
4. The apparatus of Claim 3, wherein said lockout mechanism comprises a syringe stop slidable within said first portion between a first position wherein a portion of said syringe stop blocks pivotal movement of said second portion relative to said first portion and a second position permitting pivotal movement of said second portion relative to said first portion, and biasing means for biasing the syringe stop toward said first position prior to loading the apparatus with a syringe and needle assembly.
5. The apparatus of Claim 1, further comprising an anti-reverse mechanism for permitting pivotal movement of said second portion relative to said first portion in a first rotational direction along a cutting stroke portion of a cutting cycle, and for preventing pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction until completion of the cutting stroke.
6. The apparatus of Claim 5, wherein said anti-reverse mechanism comprises a toothed ring and an interengaging anti-reverse pawl.
7. The apparatus of Claim 6, wherein said anti-reverse mechanism further comprises means for disengaging the and-reverse pawl from the toothed ring upon completion of the cutting cycle.
8. The apparatus of Claim 7, wherein the means for disengaging comprises a post movable within a slot formed in the anti-reverse pawl.
9. The apparatus of Claim 1, further comprising a counting mechanism for counting a number of cutting cycles effected by said apparatus, each cutting cycle comprising a cutting stroke comprising pivotal movement of said second portion relative to said first portion in a first rotational direction, and a return stroke comprising pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction.
10. The apparatus of Claim 9, wherein said counting mechanism comprises an orbital reducer having a first number of lobes, said orbital reduces orbitally engaged within a counter housing having a second number of seats for engaging said lobes, the second number being at least one greater than the first number, whereby orbital movement of the orbital reducer about the counter housing in a first rotational direction causes rotation of the orbital reducer in a second rotational direction opposite the first rotational direction.
11. The apparatus of Claim 10, wherein said orbital reducer is orbitally driven within said counter housing by a counting ratchet rotationally mounted within said counter housing, said counting ratchet cooperating with the counter housing to permit rotation of said counting ratchet only in the first rotational direction.
12. The apparatus of Claim 11, further comprising a counting pawl, said counting pawl rotating in the fast rotational direction upon pivotal movement of said second portion relative to said first portion in the first rotational direction, and said counting pawl rotating in the second direction upon pivotal movement of said second portion relative to said first portion in the second rotational direction, said counting pawl coupled to said counting ratchet whereby rotation of said counting pawl in the first direction imparts rotation of said counting ratchet in the first direction, but rotation of said counting pawl in the second direction does not impart substantial rotation of said counting ratchet.
13. The apparatus of Claim 9, further comprising an indicator for indicating a number of cutting cycles effected by said apparatus.
14. The apparatus of Claim 9, further comprising an overfill prevention mechanism coupled to said counting mechanism, for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus.
15, The apparatus of Claim 14, wherein said overfill prevention mechanism comprises a lockout slide slidable along a cooperating portion of said counting mechanism to permit passage of a syringe and needle assembly through a clearance opening through said lockout slide before the predetermined number of cutting cycles have been effected by said apparatus, but engaging a cooperating portion of said counting mechanism to prevent passage of a syringe and needle assembly after a predetermined number of cutting cycles have been effected by said apparatus.
16. An apparatus for detaching and disposing of a portion of a syringe and needle assembly, said apparatus comprising:
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) a counting mechanism for counting a number of cutting cycles effected by said apparatus.
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) a counting mechanism for counting a number of cutting cycles effected by said apparatus.
17. The apparatus of Claim 16, further comprising a lockout mechanism to prevent operation prior to loading the apparatus with a syringe and needle assembly.
18. The apparatus of Claim 16, further comprising an anti-reverse mechanism for preventing premature removal of a syringe and needle assembly prior to complete detachment of at least a needle portion thereof.
19. The apparatus of Claim 16, further comprising an overfill prevention mechanism coupled to said counting mechanism, for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus.
20. An apparatus for detaching and disposing of a portion of a syringe and needle assembly, said apparatus comprising:
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (o) an anti-reverse mechanism far preventing premature removal of a syringe and needle assembly prior to complete detachment of at least a needle portion thereof.
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (o) an anti-reverse mechanism far preventing premature removal of a syringe and needle assembly prior to complete detachment of at least a needle portion thereof.
21. An apparatus for detaching and disposing of a portion of a syringe and needle assembly, said apparatus comprising:
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) an overfill prevention mechanism for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus.
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) an overfill prevention mechanism for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus.
22. An apparatus for detaching and disposing of a portion of a syringe and needle assembly, said apparatus comprising:
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) a lockout mechanism for preventing operation of said apparatus prior to loading a syringe and needle assembly therein.
(a) a cutting blade for severing a portion of a syringe and needle assembly to detach at least a needle portion thereof;
(b) a receptacle for receiving the detached portion of a syringe and needle assembly; and (c) a lockout mechanism for preventing operation of said apparatus prior to loading a syringe and needle assembly therein.
23. An apparatus for disabling a syringe and needle assembly, said apparatus comprising:
(a) a first portion comprising a blade having a cutting edge;
(b) a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle assembly, whereby pivotal movement of said second portion relative to said first portion causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly;
(c) a counting mechanism for counting a number of cutting cycles effected by said apparatus, each cutting cycle comprising a cutting stroke comprising pivotal movement of said second portion relative to said first portion in a first rotational direction, and a return stroke comprising pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction, wherein said counting mechanism is incrementally advanced by movement of a counting pawl actuated by contact with said first portion; and (d) an anti-reverse mechanism for permitting pivotal movement of said second portion relative to said first portion in the second rotational direction only until completion of the cutting stroke, wherein movement of said counting pawl disengages the ants-reverse mechanism upon completion of the cutting stroke.
(a) a first portion comprising a blade having a cutting edge;
(b) a second portion, pivotally connected to said first portion, and comprising means for engaging a syringe and needle assembly, whereby pivotal movement of said second portion relative to said first portion causes the syringe and needle assembly to traverse a path intersecting the cutting edge of the blade to sever and detach a portion of the syringe and needle assembly;
(c) a counting mechanism for counting a number of cutting cycles effected by said apparatus, each cutting cycle comprising a cutting stroke comprising pivotal movement of said second portion relative to said first portion in a first rotational direction, and a return stroke comprising pivotal movement of said second portion relative to said first portion in a second rotational direction opposite the first rotational direction, wherein said counting mechanism is incrementally advanced by movement of a counting pawl actuated by contact with said first portion; and (d) an anti-reverse mechanism for permitting pivotal movement of said second portion relative to said first portion in the second rotational direction only until completion of the cutting stroke, wherein movement of said counting pawl disengages the ants-reverse mechanism upon completion of the cutting stroke.
24. The apparatus of Claim 23, further comprising an overfill prevention mechanism coupled to said counting mechanism, for preventing loading of a syringe and needle assembly into the apparatus after a predetermined number of cutting cycles have been effected by said apparatus.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US9137598P | 1998-07-01 | 1998-07-01 | |
| US60/091,375 | 1998-07-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2276837A1 true CA2276837A1 (en) | 2000-01-01 |
Family
ID=31186084
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2276837 Abandoned CA2276837A1 (en) | 1998-07-01 | 1999-06-30 | Syringe cutting apparatus |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2276837A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190362839A1 (en) * | 2017-01-12 | 2019-11-28 | The Cleveland Clinic Foundation | A system and method for monitoring surgical objects |
| CN112870493A (en) * | 2021-01-19 | 2021-06-01 | 杨万礼 | Special syringe recovery unit of hematology department |
-
1999
- 1999-06-30 CA CA 2276837 patent/CA2276837A1/en not_active Abandoned
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190362839A1 (en) * | 2017-01-12 | 2019-11-28 | The Cleveland Clinic Foundation | A system and method for monitoring surgical objects |
| US11594324B2 (en) * | 2017-01-12 | 2023-02-28 | The Cleveland Clinic Foundation | System and method for monitoring surgical objects |
| CN112870493A (en) * | 2021-01-19 | 2021-06-01 | 杨万礼 | Special syringe recovery unit of hematology department |
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| Date | Code | Title | Description |
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| FZDE | Dead |