The present application claims priority to European Application No. EP 20306206.2, entitled “End-Of-Dose Indicator for Medical Injection Device”, filed Oct. 14, 2020, the entire disclosure of which is hereby incorporated by reference in its entirety.
The present disclosure relates generally to indicators for medical injection devices, and, in particular embodiments or aspects, to visual indicators providing an indication that a dose of a medicament has been completely delivered and the medical injection device can be removed from the site of injection.
Medical injection devices often utilize indicators to inform users thereof that an injection has been completed. These indicators can take the form of audible, tactile, or visual indicators. However, in many cases the indicators are not sufficiently temporally delayed from the end of the dose, such that a user will remove the medical injection device from the site of injection before the entire dose of medicament has been delivered. Accordingly, there is a need in the art for a more robust indicator with a more reliable delay mechanism, such that full doses of a desired medicament is more reliably delivered.
Provided herein is an end-of-dose indicator device for a medical injection device, having a housing having a proximal end, a distal end, and a sidewall therebetween defining an interior, the housing configured to be secured to a proximal end of a medical injection device, a switch arranged within the housing interior and having an open position and a closed position, a circuit, and one or more indicators in electrical communication with the circuit, wherein the switch, when in the closed position, triggers the circuit to activate the indicator.
Also provided herein is a medical injection system having a medical injection device including an injection device housing having a proximal end, a distal end, and a sidewall therebetween defining an injection device interior, a syringe received within the injection device interior, the syringe comprising a proximal end having a piston, a distal end having a needle, and a sidewall therebetween defining a syringe interior configured to receive a medicament, a plunger rod received within the injection device interior and configured to displace the piston distally to cause the medicament to be expelled through the needle, a drive assembly configured to displace the plunger rod distally, and a plunger rod follower having a distal end operatively coupled to the plunger rod and a proximal end. The system also includes an end-of-dose indicator device having a housing having a proximal end, a distal end, and a sidewall therebetween defining an interior, the housing configured to be secured to a proximal end of a medical injection device, a switch arranged within the housing interior and having an open position and a closed position, a circuit, and one or more indicators in electrical communication with the circuit, wherein the plunger rod follower is configured such when as the plunger rod is displaced distally the proximal end of the plunger rod follower is displaced proximally and contacts the switch, moving the switch from the open position to the closed position and triggering the circuit to activate the indicator.
Further embodiments or aspects are provided in the following numbered clauses:
The use of numerical values in the various ranges specified in this application, unless expressly indicated otherwise, are stated as approximations as though the minimum and maximum values within the stated ranges are both preceded by the word “about”. As used herein, the term “about” means the stated value ±10%. In this manner, slight variations above and below the stated ranges can be used to achieve substantially the same results as values within the ranges. Also, unless indicated otherwise, the disclosure of these ranges is intended as a continuous range including every value between the minimum and maximum values. For definitions provided herein, those definitions refer to word forms, cognates and grammatical variants of those words or phrases.
The figures accompanying this application are representative in nature, and should not be construed as implying any particular scale or directionality, unless otherwise indicated. For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal” and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
Turning to
Housing 110 can assume any useful configuration to allow coupling to a medical injection device (not shown). In non-limiting embodiments or aspects, housing 110, when viewed in cross-section from the proximal end 120 or distal end 140 thereof (e.g.,
Housing 110 can be formed of any suitable material. In non-limiting embodiments, housing 110 is formed of polymeric materials, natural or synthetic rubber materials, metals, alloys, and/or combinations thereof. In non-limiting embodiments or aspects, proximal-facing outer surface 130 of housing 110 can include one or more resilient and/or elastomeric materials to provide an ergonomic feel, such as elastomeric polymers, synthetic and/or natural rubbers, foams, and combinations thereof.
With continuing reference to
In non-limiting embodiments, circuit 170 is a delay circuit, in that circuit 170 is configured, for example, with one or more capacitors, such that there is a delay between closure of switch 160 and supply of power to indicator 180. Such a delay provides an interval, for example, a pre-determined interval, between the end of delivery of medicament and the initiation of the indication. Those of skill in the art will appreciate that any suitable delay can be included based on basic circuity characteristics. In non-limiting aspects or embodiments, circuit 170 is configured to provide a delay between switch closure and initiation of the indication by at about 1, about 2, about 3, about 4, or about 5 seconds, all values and subranges therebetween inclusive.
In non-limiting embodiments or aspects, housing 110 can include one or more windows 190. One or more windows 190 can be arranged on housing 110 in any desired configuration. One or more windows 190 can be one or more openings in housing 110, and/or can include a translucent and/or transparent material that allows light to at least partially pass therethrough. In non-limiting embodiments or aspects, one or more windows 190 are arranged at proximal end 120, distal end 140, on proximal-facing outer surface 130 of housing 110, longitudinally between proximal end 120 and distal end 140 of housing 110, circumferentially about housing 110, and/or any combination thereof. In non-limiting embodiments or aspects, windows 190 are arranged as shown in
With reference to
Medical injection device 1100 can include an injection device housing 1120 having a proximal end 1130, a distal end 1140, and a sidewall 1160 therebetween defining an interior. Injection device housing 1120 can be a two-piece housing, for example, a proximal part and a distal part that can be assembled. Injection device housing 1120 can also include a window 1125.
Medical injection device 1100 can further include a syringe 1170 received in the interior thereof, and syringe 1170 can include a proximal end 1180, a distal end 1200, and a sidewall 1220 therebetween defining an interior configured to contain a composition, such as a medicament 1230. Syringe 1170 can further include at distal end 1200 thereof a needle 1210 with one or more openings therein for delivery of medicament 1230. Needle 1210 can be formed of any suitable material, and can be of any useful gauge. Syringe 1170 can further include at proximal end 1180 thereof a piston 1190. Piston 1190 can be configured to seal the interior of syringe 1170, and can be displaced distally to force medicament 1230 through needle 1210 to a site of injection. Piston 1190 can be formed of a natural rubber, a synthetic rubber, or mixtures thereof. In some aspects, the second component is formed of one or more of butyl rubber (including copolymers of isobutylene (about 97-98%) and isoprene (about 2-3%)), chlorinated butyl rubber, brominated butyl rubber, bromides of an isobutylene-paramethylstyrene copolymer, polyisoprene rubber, polybutadiene rubber, styrene ethylene butylene (SBS) rubber, styrene-isoprene (SIS) block polymers or styrene-isoprene/butadiene (SIBS), in which the content of styrene in the styrene block copolymer ranges from about 10% to about 70%, and preferably from about 20% to about 50%, epichlorohydrin rubber, styrene-butadiene (SBR) rubber, and mixtures thereof.
Syringe 1170 can be a pre-filled syringe, as is known in the art, and can include coatings, such as those including polydimethylsiloxane (PDMS) and/or other polymers, on sidewall 1220 and/or piston 1190 to reduce friction and/or reduce interactions between syringe 1170 components and compositions held within syringe 1170. In non-limiting embodiments, syringe 1170 is a unitary syringe, and needle 1210 is formed with the syringe barrel. In non-limiting embodiments or aspects, syringe 1170 includes a needle hub, which holds needle 1210. Syringe 1170 can be formed of any useful material, for example, plastic or glass, and piston 1190 can be formed of suitable materials such as natural and/or synthetic rubbers, polymeric materials, and the like.
In non-limiting embodiments or aspects, syringe 1170 can include a needle shield (not shown). In non-limiting embodiments or aspects, needle shield can be a one-piece needle shield formed of an elastomeric material, or a two-piece needle shield having an inner portion formed of an elastomeric material and an outer portion formed of a rigid material, such as a rigid polymeric material. Such needle shields are commonly referred to as rigid needle shields (RNS).
With continuing reference to
Medical injection device 1100 can further include a plunger rod follower 1260, having a proximal end, a distal end, and a protrusion 1270 extending proximally from proximal end. Plunger rod follower 1260 can be coupled to or otherwise interact with proximal end 1244 of plunger rod 1240. In non-limiting embodiments, plunger rod follower 1260 is configured to engage with plunger rod 1240 and injection device housing 1120 to cause plunger rod follower 1260 to move proximally once plunger rod 1240 has moved distally a certain amount. For example, and without limitation, proximal end 1244 of plunger rod 1240 can be received within an opening in plunger rod follower 1260, applying a radial force and engaging plunger rod follower 1260 with an inner wall of injection device housing 1120 through a friction fit between plunger rod follower 1260 and injection device housing 1120 or through interaction of plunger rod follower 1260 and one or more protrusions 1270 extending inward from housing 1120. This arrangement maintains proximal end of plunger rod follower spaced from proximal end 1130 of injection device housing and maintains protrusion 1270 within the interior of injection device housing 1120 and/or within opening 1150 in proximal end 1230 of injection device housing 1120.
As plunger rod 1240 moves distally during delivery of a medicament 1230, proximal end 1244 thereof is pulled out of engagement with plunger rod follower 1260, allowing plunger rod follower 1260, in non-limiting embodiments or aspects, to move radially inward and out of interaction with injection device housing 1120. Arrangement of the interior of injection device housing 1120 at proximal end 1130 thereof can cause plunger rod follower 1260 to move proximally, and cause protrusion 1270 to pass through opening 1150 in proximal end 1230 of injection device housing 1120. In non-limiting embodiments or aspects, movement of plunger rod follower 1260 proximally can cause plunger rod follower 1260 to contact proximal end 1130 of injection device housing 1100, causing an audible and/or tactile indication. In non-limiting embodiments or aspects, no such indication is provided, so as to reduce confusion and remove a false indication that may cause the user to remove the injection device 1100 from the site of injection before the injection is completed.
System 1000 also can include an end-of dose indicator device 1300 as described above. End-of-dose indicator device 1300 includes a housing 1310 having a proximal end 1320, distal end 1340, and sidewall 1350 therebetween defining an interior. As shown in
With continuing reference to
In non-limiting embodiments, circuit 1370 is a delay circuit as described above, in that circuit 1370 is configured, for example, with one or more capacitors, such that there is a delay between closure of switch 1360 and supply of power to indicator 1380. In non-limiting aspects or embodiments as described above, circuit 1370 is configured to provide a delay between switch closure and initiation of the indication by at about 1, about 2, about 3, about 4, or about 5 seconds, all values and subranges therebetween inclusive.
In non-limiting embodiments or aspects, housing 1310 can include one or more windows 1390. One or more windows 1390 can be arranged on housing 1310 in any desired configuration. One or more windows 1390 can be one or more openings in housing 1310, and/or can include a translucent and/or transparent material that allows light to at least partially pass therethrough. In non-limiting embodiments or aspects, one or more windows 1390 are arranged at proximal end 1320, distal end 1340, on proximal-facing surface 1330 of housing 1310, longitudinally between proximal end 1320 and distal end 1340 of housing 1310, circumferentially about housing 1310, and/or any combination thereof, for example, as described above and as shown in
With reference to
In non-limiting embodiments or aspects, medical injection device 1100 can also include a removable cap (not shown). In non-limiting embodiments or aspects, removable cap can be configured to remove any needle shield, such as an RNS, that is included with syringe 1170. In non-limiting embodiments or aspects, the cap is a two-piece cap, one portion of the two-piece cap (e.g., a cap remover) configured to be grasped by a used and pulled axially away from distal end 1140 of injection device housing and a second portion (e.g., a retainer) configured to grasp and remove a needle shield, such as an RNS (not shown).
Although the devices and systems have been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the systems and methods are not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present systems and methods contemplate that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
Number | Date | Country | Kind |
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20306206.2 | Oct 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/078224 | 10/12/2021 | WO |