Disclosure of Invention
The example embodiments described herein have innovative features, none of which is indispensable or solely responsible for their desirable attributes. The following description and the annexed drawings set forth in detail certain illustrative implementations of the disclosure, these implementations being indicative of several exemplary ways in which the various principles of the disclosure may be implemented. However, the illustrative examples are not exhaustive of the many possible embodiments of the disclosure. Without limiting the scope of the claims, some of the advantageous features will now be summarized. Other objects, advantages and novel features of the disclosure will be set forth in the description which follows, when considered in conjunction with the drawings, which are intended to illustrate, but not limit, the invention.
One aspect of the invention is directed to a disposable syringe comprising a hollow cylindrical barrel having a proximal end and a distal end, the distal end having a narrowed tip opening, a plunger inserted through the proximal end of the hollow cylindrical barrel, the plunger comprising a plurality of longitudinal fins extending radially from an axis, the longitudinal fins extending to the proximal end of the plunger, each longitudinal fin comprising a respective major planar surface, the longitudinal fins comprising at least a first fin, a second fin, and a third fin, wherein the major planar surfaces of the first fin are aligned with the major planar surfaces of the second fin such that the major planar surfaces of the first fin and the major planar surfaces of the second fin lie in a common plane, the major planar surfaces of the third fin are orthogonal to the common plane, the first row of holes are defined in the major planar surfaces of the first fin, the second row of holes are defined in the major planar surfaces of the second fin, and the first row of holes and the second row of holes extend parallel to the axis. The syringe further includes a spacer attached to the distal end of the plunger and a clasp including a body, a slot defined in the body, the slot configured to slidably engage a radial edge of the third fin, a pair of tabs configured to mechanically engage a pair of holes in the first and second rows of holes, and a pair of barbs at the proximal end of the clasp, the barbs facing away from the body and in a proximal direction, the barbs configured to mechanically engage an inner surface of the hollow cylindrical barrel to resist movement of the clasp in a proximal direction relative to the hollow cylindrical barrel and to slidably engage an inner surface of the hollow cylindrical barrel to permit movement of the clasp in a distal direction relative to the hollow cylindrical barrel.
In one or more embodiments, the axis is a first axis, and the holes in the first and second rows are uniformly spaced apart and aligned relative to respective second axes, the second axes being orthogonal to the first axis. In one or more embodiments, the locations of the holes in the first and second rows correspond to a predetermined volume of fluid in the syringe. In one or more embodiments, the gasket includes a gasket tip shaped to be inserted into the narrowed tip opening of the hollow cylindrical barrel.
In one or more embodiments, the syringe has a first configuration in which the plunger is fully inserted into the hollow cylindrical barrel, the tab mechanically engages a pair of proximal holes at the proximal end of the first and second rows of holes, and the catch is located between the distal and proximal ends of the hollow cylindrical barrel. In one or more embodiments, the syringe has a second configuration that occurs after the first configuration, wherein in the second configuration the plunger is partially withdrawn from the hollow cylindrical barrel, the position of the catch relative to the hollow cylindrical barrel is the same in the first configuration and the second configuration, the position of the catch relative to the plunger is closer to the distal end of the plunger in the second configuration than in the first configuration, the tabs mechanically engage a respective pair of apertures that correspond to the position of the catch relative to the plunger, and a fluid reservoir is defined between the pad and the distal end of the hollow cylindrical barrel, the fluid reservoir storing fluid. In one or more embodiments, the syringe has a third configuration that occurs after the second configuration, wherein in the third configuration the plunger is fully retracted from the hollow cylindrical barrel, the position of the catch relative to the hollow cylindrical barrel is the same in the first configuration, the second configuration, and the third configuration, the position of the catch relative to the plunger is closer to the distal end of the plunger in the third configuration than in the second configuration, the catch is located adjacent to the flange at the distal end of the plunger, the tab mechanically engages a pair of distal holes at the distal end in the first row of holes and the second row of holes, and the volume of the fluid reservoir is greater in the third configuration than in the second configuration.
In one or more embodiments, the syringe has a fourth configuration that occurs after the third configuration, wherein in the fourth configuration the plunger is partially inserted into the hollow cylindrical barrel, the tab mechanically engages the pair of distal holes, the location of the catch relative to the hollow cylindrical barrel is closer to the distal end of the hollow cylindrical barrel than in the first, second and third configurations, and the volume of the fluid reservoir is smaller in the fourth configuration than in the third configuration, such that some of the fluid flows out of the fluid reservoir through the narrowed tip opening of the hollow cylindrical barrel. In one or more embodiments, the syringe has a fifth configuration that occurs after the third configuration or the fourth configuration, wherein in the fifth configuration the plunger is fully inserted into the hollow cylindrical barrel, the tab mechanically engages the pair of distal holes, the tab is positioned adjacent to the flange at the distal end of the plunger, and the gasket is in physical contact with the distal end of the hollow cylindrical barrel, the gasket being positioned to cause fluid to flow out of the fluid reservoir through the narrowed tip opening of the hollow cylindrical barrel. In one or more embodiments, the fifth configuration is a locking configuration in which the flange prevents the catch from sliding in a distal direction relative to the plunger, the pair of barbs resist movement of the catch in a proximal direction relative to the hollow cylindrical barrel, and the position of the spacer prevents movement of the plunger in a distal direction relative to the hollow cylindrical barrel, and mechanical engagement of the tab with the pair of distal holes causes resistance in movement of the plunger in a proximal direction relative to the hollow cylindrical barrel.
In one or more embodiments, the syringe has a sixth configuration, the sixth configuration occurring after the fifth configuration, wherein in the sixth configuration the plunger breaks at a predetermined mechanical failure point of the plunger, the breaking being caused by a distal force on the plunger.
In one or more embodiments, an orientation notch is defined in the major planar surface of the third fin, the orientation notch configured to visually distinguish the third fin from the first fin and the second fin.
In one or more embodiments, the common plane is a first plane and the longitudinal fin includes a fourth fin having a major planar surface aligned with a major planar surface of the third fin such that the major planar surface of the third fin and the major planar surface of the fourth fin lie in a second plane, the second plane being orthogonal to the first plane. In one or more embodiments, an orientation notch is defined in the major planar surface of the third fin, an orientation gap is defined in the major planar surface of the fourth fin, and the orientation notch and the orientation gap are configured to visually distinguish the third fin from the first and second fins and the fourth fin from the first and second fins, respectively, and to visually distinguish the third fin from the fourth fin.
In one or more embodiments, the tab extends in a proximal direction and extends toward the first fin and the second fin.
Another aspect of the invention is directed to a method of using a disposable syringe, the method comprising placing the syringe in a fully retracted configuration, the syringe comprising a hollow cylindrical barrel having a proximal end and a distal end, the distal end having a narrowed tip opening, a plunger inserted through the proximal end of the hollow cylindrical barrel, the plunger comprising a plurality of longitudinal fins extending radially from an axis, the longitudinal fins extending to the proximal end of the plunger, each longitudinal fin comprising a respective major planar surface, the longitudinal fins comprising at least a first fin, a second fin, and a third fin, wherein the major planar surfaces of the first fin are aligned with the major planar surfaces of the second fin such that the major planar surfaces of the first fin and the second fin lie in a common plane, the major planar surfaces of the third fin are orthogonal to the common plane, the first row of holes are defined in the major planar surfaces of the first fin, the second row of holes are defined in the major planar surfaces of the second fin, and the first row of holes and the second row of holes extend parallel to the axis. The syringe further includes a washer attached to the distal end of the plunger and a catch including a body, a slot defined in the body, the slot configured to slidably engage a radial edge of the third fin, a pair of tabs configured to mechanically engage a pair of holes in the first and second rows of holes, and a pair of barbs at the proximal end of the catch, the barbs facing away from the body and in a proximal direction, the barbs configured to mechanically engage an inner surface of the hollow cylindrical barrel to resist movement of the catch relative to the hollow cylindrical barrel in the proximal direction and slidably engage the inner surface of the hollow cylindrical barrel to permit movement of the catch relative to the hollow cylindrical barrel in the distal direction. In the fully retracted configuration, the plunger is fully retracted from the hollow cylindrical barrel, a catch is located between the distal end and the proximal end of the hollow cylindrical barrel, the catch is located adjacent to a flange at the distal end of the plunger, a tab is mechanically engaged within a pair of distal holes at the distal end in the first and second rows of holes, and a fluid reservoir is defined between the gasket and the distal end of the hollow cylindrical barrel, the fluid reservoir storing fluid. The method further includes partially or fully inserting the plunger into the hollow cylindrical barrel and simultaneously with partially or fully inserting the plunger, flowing fluid out of the fluid reservoir through the narrowed tip opening of the hollow cylindrical barrel, retaining the tab in mechanical engagement with the pair of distal holes, and sliding the barb along the inner surface of the hollow cylindrical barrel in a distal direction, wherein the mechanical engagement of the tab within the pair of distal holes and the orientation of the barb automatically transition the syringe to the locked configuration after insertion of the plunger into the hollow cylindrical barrel.
In one or more embodiments, the method further includes, after the syringe is in the locked configuration, applying a separation force between the plunger and the hollow cylindrical barrel, mechanically engaging the barbs and the inner surface of the hollow cylindrical barrel to resist proximal movement of the catch relative to the hollow cylindrical barrel while applying the separation force, and mechanically engaging the tabs within the pair of distal holes to resist proximal movement of the plunger relative to the hollow cylindrical barrel while applying the separation force.
In one or more embodiments, the operation of applying a separation force breaks the plunger at a predetermined mechanical point of weakness (MECHANICAL WEAKNESS point). In one or more embodiments, the method further includes retracting the plunger from the fully inserted position to a fully retracted configuration, mechanically engaging the barbs and the inner surface of the hollow cylindrical barrel to resist proximal movement of the catch relative to the hollow cylindrical barrel while retracting the plunger, flexing the tabs while retracting the plunger to mechanically disengage the tabs from a pair of proximal holes at the proximal end in the first and second rows of holes, sliding a radial edge of the third fin in a slot of the catch while retracting the plunger to mechanically engage the pair of distal holes, and flowing fluid from the narrowed tip opening into the fluid reservoir while retracting the plunger.
In one or more embodiments, the method further includes mechanically engaging the tab with a plurality of pairs of holes between the pair of proximal holes and the pair of distal holes while retracting the plunger, and flexing the tab to mechanically disengage the tab from each pair of holes between the pair of proximal holes and the pair of distal holes.
Another aspect of the invention is directed to a disposable syringe comprising a hollow cylindrical barrel having a proximal end and a distal end, the distal end having a narrowed tip opening, a plunger inserted through the proximal end of the hollow cylindrical barrel, the plunger comprising a plurality of longitudinal fins extending radially from an axis, the longitudinal fins extending to the proximal end of the plunger, each longitudinal fin comprising a respective major planar surface, the longitudinal fins comprising at least a first fin, a second fin, and a third fin, wherein the major planar surfaces of the first fin are aligned with the major planar surfaces of the second fin such that the major planar surfaces of the first fin and the second fin lie in a common plane, the major planar surfaces of the third fin being orthogonal to the common plane, a row of holes being defined in the major planar surfaces of the first fin, and the row of holes extending parallel to the axis. The syringe further includes a washer attached to the distal end of the plunger and a catch including a body, a slot defined in the body, the slot configured to slidably engage a radial edge of the third fin, a tab configured to mechanically engage a pair of the first and second rows of holes, and a pair of barbs at the proximal end of the catch, the barbs facing away from the body and in a proximal direction, the barbs configured to mechanically engage an inner surface of the hollow cylindrical barrel to resist movement of the catch relative to the hollow cylindrical barrel in the proximal direction and to slidably engage an inner surface of the hollow cylindrical barrel to permit movement of the catch relative to the hollow cylindrical barrel in the distal direction.
Detailed Description
Disposable syringes having an automatic locking catch that prevents syringe reuse are disclosed. The syringe comprises a barrel, a plunger, an auto-lock catch and a gasket. The clasp includes a pair of tabs configured to mechanically engage a set of apertures defined in the first and second fins of the plunger. The catch is slidably attached to a third fin on the plunger, the third fin oriented orthogonal to the first fin and the second fin. The clasp includes a pair of barbs configured to mechanically engage the barrel wall to resist proximal movement of the clasp relative to the barrel and to slidably engage the barrel to permit distal movement of the clasp relative to the barrel. As soon as the plunger is pressed, the catch is activated.
After the syringe is used and when the plunger is depressed, the barbs on the catch resist movement of the catch relative to the proximal end of the barrel. The barb also resists proximal movement of the plunger relative to the barrel because the plunger is mechanically coupled to the catch. The plunger may be configured to have a predetermined point or region at which the plunger may fracture when a proximal force and/or a distal force (e.g., an excessive force in the proximal and/or distal directions) is applied to the plunger after the syringe is used. The plunger may fracture at the completion of the dose, or after pressing the plunger at any pressed distance.
The disposable syringe may be a self-destructing syringe for fixed dose immunization.
Fig. 1 is a top view of a disposable syringe 10 in a first configuration according to an embodiment. The syringe 10 includes a barrel 100, a plunger 110, a catch 120, and a gasket 130. The cartridge 100 has a hollow cylindrical body 102, the hollow cylindrical body 102 being sized to slidably receive a plunger 110. In the first configuration, the plunger 110 is fully inserted into the barrel 100.
The plunger 110 includes a plurality of fins 140 extending radially along the length of the insertable portion of the plunger 110. The first row of holes 151 and the second row of holes 152 are formed in the first fin 141 and the second fin 142, respectively.
The clasp 120 includes a pair of barbs 160 and a pair of tabs 170. The clasp 120 also includes a slot 122, the slot 122 slidably engaging the third fin 143 and mounting the clasp 120 on the third fin 143. The barbs 160 face outwardly and in a proximal direction away from the syringe tip 180 to mechanically engage the wall of the barrel 100. This orientation allows the catch 120 to slide in a distal direction relative to the barrel 100 toward the syringe tip 180 while preventing the catch 120 from sliding in a proximal direction relative to the barrel 100 toward the opening of the barrel 100. Tabs 170 are axially aligned with the rows of apertures 151, 152 and are configured to be inserted into and/or mechanically engaged within the respective apertures depending on the relative positions of the catch 120 and plunger 110.
An optional needle 190 may be attached to the syringe tip 180. Needle 190 may be used to deliver fluid (e.g., medication) to a patient or to withdraw a fluid sample from a patient. An optional needle cover 195 may cover the needle 190 until the syringe 10 is ready to be used.
The disposable syringe 10 is in the ready-to-use configuration, the assembled configuration, and/or the initial configuration of fig. 1. In this configuration, tab 170 is inserted into first aperture 201 in each row of apertures 151, 152. The first aperture 201 is the aperture at the proximal end in each row of apertures 151, 152. The first bore 201 may alternatively be referred to as a proximal bore.
Fig. 2 is a top view of the disposable syringe 10 in a second configuration according to an embodiment. The second configuration may alternatively be referred to as a partially retracted configuration. In the second configuration, the plunger 110 has been retracted in a proximal direction relative to the barrel 100, such that the plunger 110 is in a partially retracted configuration, as compared to the first configuration of the syringe 10 in fig. 1. The plunger 110 may be retracted by applying a separation force between the plunger 110 and the barrel 100 (e.g., by pulling the plunger handle 230 while holding the barrel 100, and/or by pushing the barrel 100, such as the barrel flange 240, while holding the plunger 110).
Because the catch 120 is mounted on the plunger 110 and mechanically coupled to the plunger 110 (e.g., via the tab 170), a separation force to retract the plunger 110 is also applied to the catch 120 in the proximal direction. The barbs 160 are configured to counteract a proximal force on the plunger 110 to maintain the position of the catch 120 relative to the barrel 110 (e.g., as compared to fig. 1). Because the catch 120 remains stationary, when the plunger 110 is retracted in the proximal direction, the separation force slides the plunger 110 (e.g., the fins 143) in the proximal direction relative to the catch 120. From another perspective, the separation force slides the catch 120 in a distal direction relative to the plunger (e.g., fin 143). When the catch 120 slides relative to the plunger 110 (or vice versa), the tab 170 mechanically engages the apertures 151, 152 corresponding to the relative position of the catch 120 on the plunger 110. In fig. 2, tab 170 is inserted into aperture 202. In transitioning between the first configuration (fig. 1) and the second configuration (fig. 2), tab 170 mechanically engages and/or is inserted into each pair of apertures 151, 152 between apertures 201 and 202 as clasp 120 slides relative to plunger 110, and then mechanically disengages and/or releases from each pair of apertures 151, 1552 between apertures 201 and 202 as tab 170 flexes. The pair of holes 202 are located distally compared to the pair of holes 201 such that the pair of holes 202 are located closer to the syringe tip 180 than the pair of holes 201.
In the partially retracted configuration, the fluid reservoir 210 is formed at the distal end of the cartridge 100. The fluid reservoir 210 is defined by an inner surface 220 of the barrel 100 (e.g., an inner surface of a barrel wall), the gasket 130, and the syringe tip 180. Operation of partially retracting plunger 110 causes fluid from syringe tip 180 to enter fluid reservoir 210 and flow through passage 192 in attached needle 190.
Fig. 3 is a top view of the disposable syringe 10 in a third configuration according to an embodiment. In the third configuration, the plunger 110 has been retracted in a proximal direction relative to the barrel 100, such that the plunger 110 is in a fully retracted configuration, as compared to the partially retracted configuration illustrated in fig. 2.
As the plunger 110 is further retracted, the barbs 160 continue to counteract the proximal force on the plunger 110 to maintain the position of the catch 120 relative to the barrel 100 (e.g., as compared to fig. 1 and 2). Because the catch 120 remains stationary, as the plunger 110 is further retracted in the proximal direction, the separation force causes the plunger 110 (e.g., the fins 143) to continue to slide in the proximal direction relative to the catch 120. From another perspective, the separation force causes the catch 120 to continue to slide in a distal direction relative to the plunger (e.g., fin 143). When the catch 120 slides relative to the plunger 110 (or vice versa), the tab 170 mechanically engages the apertures 151, 152 corresponding to the relative position of the catch 120 on the plunger 110. When the plunger 110 is fully retracted, the tab 170 is aligned with the pair of distal holes 203 in each row of holes 151, 152 and is inserted into the pair of distal holes 203 and/or mechanically engaged within the pair of distal holes 203. Distal hole 203 is the last hole at the distal end in each row of holes 151, 152. In the transition between the second configuration (fig. 2) and the third configuration (fig. 3), tab 170 mechanically engages holes 151, 152 between holes 202 and 203 and/or is inserted into holes 151, 152 as clasp 120 slides relative to plunger 110, and then mechanically disengages and/or releases from each pair of holes 151, 152 between holes 202 and 203 as tab 170 flexes. The hole 203 is located distally compared to the holes 201, 202 such that the hole 202 is located between the holes 201 and 203.
When tab 170 is inserted into aperture 203, the distal end of catch 120 is positioned adjacent flange 300 at the distal end of plunger 110 and/or in direct physical contact with flange 300. Flange 300 is configured to limit axial movement of catch 120 relative to the distal end of plunger 110. When the user pulls the plunger 110 in a proximal direction to further retract the plunger 110 from the barrel 110, the flange 300 prevents the catch 120 from sliding in a distal direction relative to the plunger 110. From another perspective, flange 300 prevents plunger 110 from sliding in a proximal direction relative to catch 120, such that any proximal force on plunger 110 is also applied to catch 120 (e.g., via flange 300). Because barbs 160 prevent or resist retraction of plunger 110 in a proximal direction relative to barrel 100 (e.g., as discussed above), plunger 110 cannot be further retracted.
The volume of the fluid reservoir 210 is greater when the plunger 110 is in the fully retracted configuration (fig. 3) than when it is in the partially retracted configuration (fig. 2). In some embodiments, the locations of the apertures 151, 152 correspond to a predetermined volume of the fluid reservoir 210. For example, in one embodiment, the volumetric capacity of the fluid reservoir 210 may be 0.5 ml in the fully retracted configuration. Each pair of apertures 151, 152 may correspond to a predetermined fraction (e.g., 1/8) of the volumetric capacity of the fluid reservoir 210. For example, a first pair of holes 151, 152 (e.g., first hole 201) at the proximal end in the plurality of rows of holes may correspond toOr 0.0625 ml, the second set of apertures 151, 152 immediately adjacent to the first aperture 201 may correspond toOr a fluid reservoir capacity of 0.125 ml, and so on. In general, the incremental predetermined fraction of the volumetric capacity of each pair of apertures 151, 152 may be equal toWhere N is equal to the number of pairs of apertures 151, 152 and Vol res is equal to the volumetric capacity of the fluid reservoir 210.
Note that in other embodiments, the volumetric capacity of the fluid reservoir 210 may be greater than or less than 0.5ml in the fully retracted configuration of the plunger 110. For example, the volumetric capacity of the fluid reservoir 210 in the fully retracted configuration of the plunger 110 may be 0.1 ml, 0.25 ml, 0.3 ml, 0.5ml, 1 ml, or 5ml, or another volume in the fully retracted configuration.
The operation of fully retracting the plunger 110 causes additional fluid to enter the fluid reservoir 210 (e.g., through the syringe tip 180) as compared to the operation of partially retracting the plunger 110 (fig. 2).
Fig. 4 is a top view of the disposable syringe 10 in a fourth configuration according to an embodiment. In this figure, the plunger 110 has been inserted in a distal direction relative to the barrel 100, such that the plunger 110 is in a partially inserted configuration, as compared to the fully retracted configuration illustrated in fig. 3. The plunger 110 may be inserted by applying an insertion force between the plunger 110 and the barrel 100 (e.g., by pushing the plunger handle 230 while holding the barrel 100, and/or by pulling the barrel 100, such as the barrel flange 240, while holding the plunger 110).
Because the catch 120 is mounted on the plunger 110 and mechanically coupled to the plunger 110 (e.g., via the tab 170 in the distal-end-to-hole 203), an insertion force to insert the plunger 110 is also applied to the catch 120 in the distal direction. The orientation of the barbs 160 allows the barbs 160 to slidably engage the wall of the barrel 100 to allow the catch 120 to move with the plunger 100 in a distal direction within the barrel 100. Thus, in contrast to the fully retracted configuration illustrated in fig. 3, the plunger 110, catch 120, and washer 130 are moved together in the distal direction within the barrel 100.
As the plunger 110, catch 120, and washer 130 move in the distal direction within the barrel 100, a portion of the fluid in the fluid reservoir 210 flows out of the syringe tip 180 and through the channel 192 in the needle 190.
After plunger 110 is depressed, barbs 160 resist proximal movement of catch 120 relative to barrel 100 to prevent reuse of syringe 10.
Fig. 5 is a top view of the disposable syringe 10 in a fifth configuration according to an embodiment. In this figure, the plunger 110 has been inserted distally relative to the barrel 100 such that the plunger 110 is in a fully inserted configuration, as compared to the partially inserted configuration illustrated in fig. 4.
To transition from the partially inserted configuration (fig. 4) to the fully inserted configuration (fig. 5), an insertion force is applied between the plunger 110 and the barrel 100. Because the catch 120 is mounted on the plunger 110 and mechanically coupled to the plunger 110 (e.g., via the tab 170 in the distal-end-to-hole 203), an insertion force to insert the plunger 110 is also applied to the catch 120 in the distal direction. The orientation of the barbs 160 allows the barbs 160 to slidably engage the wall of the barrel 100 to allow the catch 120 to move with the plunger 100 in a distal direction within the barrel 100. Thus, in contrast to the partially retracted configuration illustrated in fig. 4, the plunger 110, catch 120, and washer 130 are moved together in a distal direction within the barrel 100. Plunger 110, catch 120, and washer 130 move in a distal direction within barrel 100 until washer 130 contacts the distal end of barrel 100.
As the plunger 110, catch 120, and spacer 30 move in the distal direction within the barrel 100, the remainder of the fluid in the fluid reservoir 210 (fig. 4) flows out of the syringe tip 180 and through the channel 192 in the optional needle 190.
It can be seen that the spacer 130 is shaped to fit inside the distal end of the barrel 100. The shim 130 also includes an optional shim tip 530, the shim tip 530 being shaped to be inserted into the interior (e.g., channel) of the syringe tip 180. The shape of the gasket 130 allows all or substantially all of the fluid in the fluid reservoir 210 to flow out of the syringe tip 180. When the syringe 10 is used to deliver a therapeutic fluid (e.g., a drug or vaccine), the shape of the pad 130 may reduce waste that would occur with other shapes of pads having a small amount of fluid left in the syringe (e.g., in the syringe tip 130).
After the plunger 110 is partially or fully inserted into the barrel 100 (as illustrated in fig. 4 and 5, respectively), the configuration of the catch 120 automatically causes the syringe 10 to be placed in a locked configuration in which the plunger 110 cannot be retracted from its current position within the barrel 100. Ideally, the syringe 10 will be discarded in this configuration because it cannot (or at least should not) be reused. To reuse the syringe 10, the plunger 110 will need to be retracted within the barrel 100, for example, to measure another dose of medication or to collect a fluid sample from another patient. However, as discussed, the barbs 160 on the clip 120 are configured and/or oriented to prevent and/or resist movement or sliding of the clip 120 in a proximal direction within the barrel 100. Because the catch 120 is mechanically coupled to the plunger 110 (e.g., via the tab 170 and the distal-to-hole 203), the barbs 160 on the catch 120 prevent and/or resist retraction of the plunger 110.
Note that in the locked configuration, if sufficient force is applied, the plunger 110 may be retracted within the barrel 100. For example, if the proximal force applied to the plunger is greater than the locking force of the barbs 160 on the barrel 100, the plunger 110 may be retracted within the barrel 100. Additionally, if the tab 170 fails mechanically (in which case the catch 120 becomes mechanically disconnected from the plunger 110, which allows the plunger 110 to move freely within the barrel 100 relative to the catch 120), the plunger 110 may be retracted within the barrel 100.
As a further safety feature, the plunger 110 may be formed with a predetermined mechanical failure point, region, or area. The predetermined mechanical failure point/zone may be a mechanically frangible point, zone or zone on the plunger 110 as compared to the remainder of the plunger 110. The mechanical weakness may be formed by using less material in a predetermined mechanical failure point, region or zone than the remainder of the plunger 110. Additionally or alternatively, the mechanical weakness may be formed using mechanical scoring or perforation. Additionally or alternatively, the mechanical weakness may be formed by using a smaller amount of adhesive in a predetermined mechanical failure point, region or zone than other portions of the plunger 110. The predetermined mechanical failure point, region or zone is configured to render the syringe unusable when excessive force is applied to the plunger 110 (e.g., when the plunger 110 is attempted to be retracted after use or after any distal movement of the plunger 110 in the barrel 100 (e.g., relative to the initial configuration or the first configuration or another configuration)). For example, the predetermined mechanical failure point, region, or zone may be configured to render the syringe 10 unusable (e.g., to fracture some or all of the plunger 110) when a force is applied between the plunger 110 and the barrel 110, where the force may be about 16N (newtons) to about 20N, including about 17N, about 18N, about 19N, and any value or range between any two of the foregoing forces. As used herein, "about" means plus or minus 10% of the relevant value.
Fig. 6 is a top view of the disposable syringe 10 in an alternative sixth configuration according to an embodiment. In this figure, after the plunger 110 is in the fully inserted configuration (fig. 5), the plunger 110 has been retracted within the barrel 100. The proximal force on plunger 110 breaks distal end 600 of fin 140 away from flange 300, thereby rendering syringe 10 unusable. In this embodiment, the mechanical failure point/region/zone is in the junction 610 (fig. 1) between the fin 140 and the flange 300.
Fig. 7 is a top view of a cartridge 700 according to an embodiment. The cartridge 700 may be the same as or different from the cartridge 100.
The cartridge 700 includes a flange 710, a hollow cylindrical body 720, and a narrowed tip 730. A flange 710 is located at the proximal end of the barrel 700. The tip 730 is located at the distal end of the barrel 700. The hollow cylindrical body 720 and the tip 730 are aligned along an axis 740. Tip 730 contains a passageway 732 through which fluid can flow into and out of hollow cylindrical body 720. Tip 730 may be mechanically coupled to the needle. Additionally or alternatively, the tip 730 may include external threads to form a needle lock. The hollow cylindrical body 720 has an interior volume at least partially defined by a wall 722. The hollow cylindrical body 720 has an inner diameter 750, the inner diameter 750 being configured to allow the plunger to be received and mechanically engage barbs on the catch.
Various example dimensions and angles are illustrated in fig. 7 for reference purposes only.
Fig. 8 and 9 are top and side views, respectively, of a plunger 800 according to an embodiment. Plunger 800 may be the same as or different from plunger 110.
Plunger 800 includes a handle 810, a plurality of fins 820, a flange 830, and a tip 840. A handle 810 is located at the proximal end of plunger 800. A tip 840 is located at the distal end of the plunger 800. The handle 810, fins 820, flange 830, and tip 840 are aligned and/or centered with respect to an axis 850, which may be an axis of symmetry. Fins 820 extend radially from axis 850 and extend along the length of plunger 800 from flange 830 to handle 810.
The opposing fins 821, 822 include a first section 822 and a second section 824. The width of the fins 821, 822 measured relative to the axis 860 is greater in the first section 822 than in the second section 824. The combined width of the first sections 822 of the fins 821, 822 is smaller or slightly smaller than the inner diameter 750 of the hollow cylindrical body 720 (fig. 7) of the cartridge 700 to allow the first sections 822 of the fins 821, 822 to fit therein. The length of the first section 822 measured relative to the axis 850 is substantially equal to the length of the hollow cylindrical body 720 of the cartridge 700 measured relative to the axis 740. The first section 822 may be an insertable section of the fins 821, 822.
The narrowed width of the second sections 824 of fins 821, 822 is similar to an axle that a user may grasp along with handle 810. In another embodiment, the fins 821, 822 do not include the second section 824, in which case the fins 821, 822 may have a uniform width along some or all of their length that is less than or slightly less than the inner diameter 750 of the hollow cylindrical body 720.
The opposing fins 823, 824 comprise a first section 922 (fig. 9) and a second section 924. The width of the fins 823, 824, measured relative to the axis 960, is greater in the first section 922 than in the second section 924. Axes 850, 860, and 960 are orthogonal to each other. The combined width of the first sections 922 of the fins 823, 824 is smaller or slightly smaller than the inner diameter 750 of the hollow cylindrical body 720 (fig. 7) of the cartridge 700 to allow the first sections 922 of the fins 823, 824 to fit therein. The combined width of the first sections 922 of the fins 823, 824 may be approximately equal to the combined width of the first sections 922 of the fins 821, 822. The length of the first section 922 measured relative to the axis 850 may be approximately equal to or less than the length of the first section 822. In some embodiments, fins 824 may be optional.
Each fin 821-824 has a respective radial edge 881-884, the radial edges 881-884 having surfaces that are orthogonal to the major planar surfaces of the respective fins 821-824. For example, the fins 821 have radial edges 881, the radial edges 881 having surfaces that are orthogonal to the major planar surfaces of the fins 821. The fins 822 have radial edges 882, the radial edges 882 having surfaces that are orthogonal to the major planar surfaces of the fins 822. The fin 823 has a radial edge 883, the radial edge 883 having a surface that is orthogonal to the major planar surface of the fin 823. The fins 824 have radial edges 884, the radial edges 884 having surfaces that are orthogonal to the major planar surfaces of the fins 824. Each radial edge 881-884 extends along a length of a respective fin 821-824, measured relative to axis 850. The width of each radial edge defines the thickness of the respective fin 820. For example, the width of the radial edge 883 measured relative to the axis 860 defines the thickness of the fin 823.
The radial edge 883 of the fin 823 may be configured and dimensioned to receive and/or mechanically engage with a slot on the clasp (e.g., slot 122) to allow the clasp to be mounted (e.g., slidably mounted) thereon. Alternatively, the radial edge 884 of the fin 824 may be configured and dimensioned to receive and/or mechanically engage with a slot on a clip (e.g., slot 122) to allow the clip to be mounted (e.g., slidably mounted) thereon.
The narrowed width of the second section 924 of the fins 823, 824 is similar to an axis that a user can grasp along with the handle 810, for example in combination with the second section 824 of the fins 821, 822. In another embodiment, the fins 823, 824 do not include the second section 924, in which case the fins 823, 824 may have a uniform width along some or all of their length that is less than or slightly less than the inner diameter 750 of the hollow cylindrical body 720.
The orientation sections 926 of the fins 823, 824 are defined between the first section 922 and the second section 924. One or more orientation features defined in the orientation section 926 may be automatically detected by a machine (e.g., by a sensor, such as an optical sensor) to position the clasp 120 on the predetermined fin 820. The catch 120 is preferably positioned and/or mounted on the radial edge 883 of the fin 823.
In the orientation section 926, an orientation notch 900 is defined in the fin 823 and an orientation gap 910 is defined in the fin 824. The orientation notch 900 is located in a portion of the fin 823 that has approximately the same width as the first section 922 of the fin 823. The orientation notch 900 may alternatively be described as being defined at the proximal end of the first section 922 of the fin 823. The orientation gap 910 is defined in a portion of the fin 824 that has approximately the same width as the first section 922 of the fin 824. The orientation gap 910 may alternatively be described as being defined at a proximal end of the first section 922 of the fin 824 and/or between the first section 922 and the second section 924 of the fin 824. The orientation gap 910 is preferably aligned with the notch 900 and/or centered with respect to the notch 900, such as with respect to the axis 970. Axis 970 is parallel to axis 960. The orientation gap 910 is wider than the orientation notch 900 as measured relative to the axis 850.
The machine may use orientation features (e.g., orientation notches 900 and orientation gaps 910) to automatically distinguish (e.g., by optical sensors) between fins 821, 822 and fins 823, 824. The machine may also use features (e.g., notches 900 and gaps 910) to automatically distinguish (e.g., by optical sensors) fins 823 from fins 824. For example, the difference in width of notch 900 and gap 910 may be used to visually distinguish fin 823 from fin 824. The assembly machine may be mechanically configured to align the plungers in a direction to ensure that the snaps are assembled on the correct fins.
Each fin 821-824 has a respective major planar surface 831-834. The major planar surfaces 831, 832 are parallel to one another and lie in a first common plane defined by the axes 850, 860. The major planar surfaces 833, 834 of the fins 823, 824 are parallel to each other and orthogonal to the major planar surfaces 831, 832. The major planar surfaces 833, 834 lie in a second common plane defined by the axes 850, 960.
A respective row of holes 871, 872 is defined in each planar surface 831, 832. The holes 870 in each row 871, 872 are aligned along respective axes 891, 892, the axes 891, 892 being parallel to the axis 850. The holes 870 are preferably evenly spaced along each axis 891, 892 in each row 871, 872. The aligned holes 870 in the first and second rows 871, 872 form multiple pairs or groups 880 of holes, which may alternatively be referred to as columns of holes. As described above, the spacing and/or location of the apertures 870 may correspond to a volume equivalent and/or volume scale of the fluid reservoir 210 (e.g., FIG. 2). Each row 871, 872 preferably has the same number of holes 870. The holes 870 in each row 871, 872 are preferably aligned and/or centered with respect to a respective axis parallel to the axis 860. The alignment of the holes 870 in each row 871, 872 may allow the tabs 170 (e.g., fig. 1) on the buckle 120 to mechanically engage within and/or be inserted into the multiple pairs/sets 880 holes 870 in each row 871, 872.
In the embodiment illustrated in fig. 8, the aperture 870 is rectangular (e.g., in a cross-section parallel to the planar surfaces 831, 832). In other embodiments, the aperture 871 may be square, trapezoidal, triangular, oval, circular, or another shape.
In some embodiments, fins 821-824 may be integrally formed as a single structure, such as by molding or injection molding.
Fig. 10 is an end view looking from the distal end toward the proximal end of plunger 800. Flange 830 and tip 840 have been removed to further illustrate the relative orientation of fins 821-824.
Fig. 11 is a top view of a plunger 1100 according to another embodiment. Plunger 1100 is identical to plunger 800 except that plunger 1100 includes a circular aperture (e.g., in a cross-section parallel to planar surfaces 831, 832). In addition, the length of the second section 824 measured relative to the axis 850 is shorter in the plunger 1100 than in the plunger 800.
Fig. 12 is a top view of a plunger 1200 according to another embodiment. Plunger 1200 is identical to plunger 800 except that plunger 1200 contains only one row 871 of holes 870. The aperture 870 is illustrated as rectangular (e.g., in a cross-section parallel to the planar surfaces 831, 832), but may be another shape as discussed above. The holes 870 are preferably evenly spaced and aligned relative to the axis 891.
Fig. 13 is a bottom perspective view of clasp 1300 according to an embodiment. Clasp 1300 may be identical to clasp 120.
Clasp 1300 includes a body 1310, a pair of barbs 1320, and a pair of tabs 1330. The body 1310 has a generally rectangular shape, but may be another shape, such as oval or square. A slot 1312 is defined in the back of the body 1310 (which faces away from the page in the bottom view illustrated in fig. 13). The slots 1312 are configured to mount the body 1310 of the clasp 1300 to a radial edge of a fin (e.g., radial edge 883 of fin 823). For example, the slot 1312 may have a width 1322 measured relative to the axis 1301, the width 1322 being about the same as or slightly greater than the width of the radial edge of the fin to allow the slot 1312 to slidingly engage the radial edge of the fin. The slot 1312 extends the length of the body 1310 along an axis 1302, the axis 1302 being orthogonal to the axis 1301.
A dimple 1314 may be formed in the catch 1300. The dimples 1314 may reduce scraping of the cartridge wall by the flat surfaces of the clasp 1300 (e.g., on both sides of the clasp 1300). For example, without the indentation 1314, a scratch would be formed during ingestion of a dose with the plunger, and further more scratches would be formed when the plunger is depressed. Scraping is undesirable because it can affect the integrity of the syringe. Thus, the dimples 1314 (e.g., two dimples) can reduce drag on the cartridge wall and prevent the cartridge from being damaged prior to use (e.g., administration of a drug).
Each barb 1320 has a point 1322, the point 1322 facing outward (e.g., away from the axis 1302) and in a proximal direction. The points 1322 of the barbs 1322 are oriented away from each other. Barb 1300 is configured to mechanically engage the wall of the barrel when catch 1312 is pushed in a proximal direction 1340 relative to the barrel. The barbs 1300 are configured to flex inwardly and slidably engage the inside surface of the barrel when the catch 1312 is pushed in the distal direction 1350 relative to the barrel.
The tab 1330 extends away from the body 1310 and toward the fin 1400 in a proximal direction 1340, such as illustrated in fig. 14, fig. 14 being a side view of the clasp 130. Tabs 1330 are configured to mechanically engage within holes 1410 in fins 1400 and/or to be inserted into holes 1410. The tab 1330 may be flexible to allow the tab 1330 to transition from one set of holes in the fin to an adjacent set of holes when the catch is moved in the distal direction 1350 relative to the fin and plunger. For example, the tab 1330 is configured to flex away from the fin 1400 and the holes 1410 in an upward direction 1360 when the tab 1330 is inserted into one of the holes 1410 (only one representative hole is illustrated in fig. 14), and the tab 1330 is moved relative to the hole in a distal direction 1350, which causes the edge of the hole to push the tab 1330 in the upward direction 1360. The upward direction 1360 is orthogonal to the proximal direction 1340 and the distal direction 1350. The orientation of the tab 1330 is such that the tab 1330 resists buckling when a force is applied in the proximal direction 1340 so as to resist movement of the clasp 1300 in the proximal direction 1340.
Clasp 1300 may be formed of stainless steel (e.g., about 0.1 mm to about 0.3 mm thick, such as about 0.2mm thick), aluminum, plastic, and/or another material. The tab 1330 may be formed from a thinner sheet of material than the body 1310 so that the tab 1330 is flexible. For example, the young's modulus of tab 1300 may be less than the young's modulus of body 1310.
Fig. 15 is a bottom perspective view of a clasp 1500 according to another embodiment. Clasp 1500 is identical to clasp 1300 except clasp 1500 has only one tab 1330 and clasp 1300 has two tabs 1330. The catch 1500 is configured for use with the plunger 1200. Clasp 1300 is configured for use with plunger 800.
Fig. 16 is a flow chart of a method 1600 for using a disposable syringe according to an embodiment.
In step 1610, the syringe is placed in a retracted configuration. The retracted configuration may be a partially retracted configuration (e.g., as illustrated in fig. 2) or a fully retracted configuration (e.g., as illustrated in fig. 3). Placing the syringe in the retracted configuration may include applying a separation force between a plunger and a barrel of the syringe to transition the syringe from an initial configuration (e.g., as illustrated in fig. 1) to the retracted configuration. The separation force may comprise a proximal force on the plunger relative to the barrel that slides the plunger in a proximal direction relative to the barrel. When the plunger is retracted (e.g., due to insertion and/or mechanical coupling of the tab(s) on the catch and the hole in the plunger fin), the catch is releasably mechanically coupled to the plunger.
Barbs on the snap-fit (which are oriented in a proximal direction and outwardly toward the barrel wall) mechanically engage the barrel wall and resist proximal movement of the snap-fit within the barrel. The barbs are configured to slidably engage the cartridge wall when the catch is moved distally within the cartridge. The resistance to proximal movement of the catch within the barrel changes the relative positions of the catch and plunger such that the plunger moves in a proximal direction within the barrel while the catch remains in a fixed position within the barrel. As the relative positions of the catch and plunger change, the tab(s) flex and mechanically engage different hole(s) in the plunger. When the plunger is fully retracted, the tab(s) mechanically engage the hole(s) at the distal end of the plunger. The plunger is partially retracted, the tab(s) mechanically engaging one of the hole(s) between the distal and proximal ends of the plunger. When the plunger is retracted, fluid flows through the syringe tip into the fluid reservoir at the distal end of the barrel.
In step 1620, the plunger is partially or fully retracted into the barrel such that the syringe is in a partially or fully inserted configuration, for example as illustrated in fig. 3 and 4, respectively. The plunger may be inserted by applying an insertion force between the plunger and the barrel. The insertion force may cause the plunger to be inserted into the barrel. Because the catch is mechanically coupled into the plunger (e.g., via the tab(s) and hole(s) as discussed in step 1610), the insertion force causes a distal force to be applied to the plunger and catch. The orientation of the barbs on the catch allows the catch to slidably engage the cartridge wall, allowing the catch to move in the distal direction in the cartridge along with the plunger. When the plunger and the spacer attached to the distal end of the plunger are moved in the distal direction, fluid is expelled from the fluid reservoir. Fluid flows out of the syringe tip and through an optional needle attached thereto.
In the fully inserted configuration, the gasket contacts and/or is pressed against the distal end of the barrel.
In step 1630, the syringe is automatically placed in the locked configuration when the plunger is partially or fully inserted into the barrel. The locking configuration is provided by a mechanical coupling of the catch and plunger (e.g., by insertion and/or mechanical engagement of the tab(s) in the catch and the aperture in the plunger) and a configuration of the barb on the catch that resists proximal movement in the barrel. In the locked configuration, the plunger and catch resist operation of being retracted within the barrel, which will not allow the syringe to be reused.
When the plunger is partially retracted in step 1610, the tab is mechanically engaged within one of the hole(s) between the distal and proximal ends of the plunger and/or inserted into the hole(s) between the distal and proximal ends of the plunger. The tab remains engaged within the aperture(s) in steps 1620 and 1630. When a separation force is applied between the plunger and the barrel, the tab translates the proximal force on the plunger to the catch when an attempt is made to improperly reuse the syringe. Barbs on the snaps resist proximal movement of the snaps within the barrel. The resistance to proximal movement of the catch within the barrel changes the relative positions of the catch and plunger such that the plunger moves in a proximal direction within the barrel while the catch remains in a fixed position within the barrel. The plunger is moved in the proximal direction until the tab(s) engage the hole(s) at the distal end of the plunger. When the tab(s) engage the hole(s) at the distal end of the plunger, the flange at the distal end of the plunger contacts the distal end of the catch to prevent any further distal movement of the catch relative to the plunger. In other words, the flange prevents any further proximal movement of the plunger relative to the catch. The separation force is thus applied to both the plunger and the catch, and the separation force is resisted by the barb, thus locking any further proximal movement of the plunger within the barrel.
When the plunger is fully retracted in step 1610, the tab is mechanically engaged within and/or inserted into the hole(s) at the distal end of the plunger. The tab remains engaged within the aperture(s) in steps 1620 and 1630. When the tab(s) engage the hole(s) at the distal end of the plunger, the flange at the distal end of the plunger contacts the distal end of the catch to prevent any further distal movement of the catch relative to the plunger. In other words, the flange prevents any further proximal movement of the plunger relative to the catch. Any separation force is thus applied to both the plunger and the catch, and the separation force is resisted by the barb, thus locking any proximal movement of the plunger within the barrel.
In some embodiments, resistance to distal movement of the plunger within the barrel breaks the plunger at a predetermined location when the syringe is in the locked state. The predetermined location may be a mechanically weak predetermined point or area in the syringe. Breaking of the plunger may render the syringe unusable.
The present invention should not be considered limited to the particular embodiments described above, but rather should be understood to cover all aspects of the invention as fairly set out in the attached claims. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the present disclosure. The claims are intended to cover such modifications and equivalents.
Further, as described, some aspects may be implemented as one or more methods. Acts performed as part of the method may be ordered in any suitable way. Thus, embodiments may be constructed in which acts are performed in a different order than illustrated, which may involve performing some acts simultaneously, even though not shown as sequential acts in the illustrative embodiments.