Apparatuses and methods for injecting medicaments

The disclosure relates to injectors that are configured to inject and deliver medicaments and other fluids from a syringe into a target site.

FIELD

The invention relates to injectors for medicaments and other fluids. Specifically, to injectors configured to inject a medicament and other fluids from a syringe.

BACKGROUND

Many methods are used to inject medicaments and other fluids into a target site. These include syringes, auto-injectors, and drug pumps. The medicament can be injected at a variety of depths. For example, the medicament can be injected into the epidermis, the dermis, the subcutaneous region, or into the muscles (intramuscular). Medicament or other fluids can also be delivered intravenously, intraosseusly, and/or to other parts of the body such as into the eye. Some of these devices are specifically intended for at home use by a patient. These devices can be used to deliver a variety of medicaments. For example, the injectors can be used for the delivery of epinephrine to patients who are at risk of anaphylaxis. Such devices include the ANAPEN™ injector sold by Lincoln Medical Ltd. of the United Kingdom and the EPIPEN® injector sold by Mylan Inc. of Pennsylvania.

Many injectors use powerful springs to drive a plunger rod into a pre-filled syringe and inject the medicament into the tissue while pushing the injector into the side of the leg or other body location. Some of these injectors have the advantage of visually shielding the needle before and/or after use, thereby benefiting patients who have a fear of needles. Present injectors can contain more than twenty-six parts, including electronics and even speakers, and may be complicated to assemble due to the amount and complexity of the parts, which contributes to high prices for the user. The additional parts also increase the chance of failure of these complex devices.

SUMMARY

In one or more embodiments, an injector includes an outer tubular sleeve defining a longitudinal axis. In one or more embodiments, the injector includes a cam disposed within the outer sleeve. In one or more embodiments, the injector includes an inner sleeve disposed partially within the outer sleeve and a first end of the inner sleeve is configured to engage with the cam. In one or more embodiments, the injector includes a syringe comprising a barrel, a needle mounted to an end of the barrel, a plunger, and a seal slidably mounted in the barrel. In some embodiments, the plunger is engaged with the outer sleeve in a fixed spatial relationship such that the plunger and outer sleeve translate as a unit throughout operation of the injector. In some embodiments, the outer sleeve is disposed and configured for axial translation relative to the inner sleeve from a first configuration. In some embodiments, the inner sleeve is configured to extend from the outer sleeve a first distance to a second configuration in which the inner sleeve extends from the outer sleeve a second distance that is less than the first distance. In some embodiments, the inner sleeve is further configured to extend from the outer sleeve a to a third configuration in which the inner sleeve extends from the outer sleeve a third distance that is greater than the second distance and the cam rotates from a first position to a second position thereby restricting the inner sleeve from axially translating with respect to the outer sleeve.

In one or more embodiments, a medicament delivery system includes an injector. In some embodiments, the injector includes an outer tubular sleeve defining a longitudinal axis. In some embodiments, the injector includes a cam disposed within the outer sleeve. In some embodiments, the injector includes an inner sleeve disposed partially within the outer sleeve and a first end of the inner sleeve is configured to engage with the cam. In some embodiments, the injector includes a syringe comprising a barrel, a needle mounted to an end of the barrel, a plunger, and a seal slidably mounted in the barrel. In some embodiments, the plunger is engaged with the outer sleeve in a fixed spatial relationship such that the plunger and outer sleeve translate as a unit throughout operation of the injector. In some embodiments, the outer sleeve is disposed and configured for axial translation relative to the inner sleeve from a first configuration. In some embodiments, the inner sleeve is configured to extend from the outer sleeve a first distance to a second configuration in which the inner sleeve extends from the outer sleeve a second distance that is less than the first distance. In some embodiments, the inner sleeve is further configured to extend from the outer sleeve a to a third configuration in which the inner sleeve extends from the outer sleeve a third distance that is greater than the second distance and the cam rotates from a first position to a second position thereby restricting the inner sleeve from axially translating with respect to the outer sleeve. In one or more embodiments, the medicament delivery system includes an adapter configured to couple to a second end of the inner sleeve.

DETAILED DESCRIPTION

The present disclosure describes an injector for injecting medicament into a target site. The injector provides for easy use by a medical professional, caregiver, or self-administration by patient and is configured for reliable use after being stored for long periods of time. In addition, because the injector utilizes a low number of parts, it is inexpensive and easy to manufacture. The injectors described herein can be used to deliver, for example, epinephrine, ketamine, atropine, diazepam, or naloxone.

FIG. 1shows a side view of an injector100according to one embodiment, andFIG. 2shows a side cross-sectional view of the injector100.FIG. 3shows an exploded view of the injector100. The injector100includes a plunger102, a biasing member104, a syringe106, a cam108, an inner sleeve110, an outer sleeve112, a needle cover engagement member114, and a cap116. As shown inFIG. 2, the syringe106is disposed in a chamber defined by the inner sleeve110, the outer sleeve112, and the cap116. As described in further detail herein, when a user desires to inject the medicament contained in the syringe106, the user removes the cap116and selectively deploys the needle of the syringe106to inject the medicament.

FIG. 4shows an exploded view of the cam108, the inner sleeve110, and the outer sleeve112. As described in further detail herein, the cam108, the inner sleeve110, and the outer sleeve112work together to: (i) cover the needle of the syringe prior to insertion of the needle in the injection site; (ii) provide audible (e.g., a “click”) and/or tactile feedback upon completion of injection of the medicament; and (iii) cover the needle of the syringe after completion of injection to prevent inadvertent needle stick injuries.

As shown inFIG. 2, the cam108is disposed within the outer sleeve112and is configured for axial translation within the outer sleeve112. As described in more detail herein, the cam108is also configured to rotate within the outer sleeve112during use of the injector100.FIG. 5Ashows a perspective view of the cam108andFIG. 5Bshows an end view of the cam108. The cam108includes a cylindrical body120and a ring122extending from the cylindrical body120and having a larger outer diameter than the cylindrical body120—for example, at one end of the cylindrical body120. The cam108further includes a plurality of protrusions124extending radially outward from the ring122. The protrusions124are circumferentially spaced around the ring122. The protrusions124are configured to guide translation and rotation of the cam108within the outer sleeve112during use, as described herein. The cam108further includes cam elements126extending from the outside of the cylindrical body120—for example, adjacent to the ring122. The cam elements126each include a cam face128. The cam faces128are angled relative to the circumference of the cylindrical body120such that engagement with corresponding faces on the inner sleeve110imparts a circumferential force on the cam108that causes the cam108to rotate at desired times during operation of the injector100, as described in detail herein. The cylindrical body120defines an aperture130to allow for the passage of the plunger102.

FIG. 6shows a perspective view of the inner sleeve110, andFIG. 37shows a perspective view of an alternative inner sleeve110.FIG. 7shows a detailed perspective view of an end of the inner sleeve110.FIG. 8shows a cross-sectional perspective view of the inner sleeve110.FIG. 9shows an end view of the inner sleeve110. The inner sleeve110includes a cylindrical body134extending from a first end136to a second end138. The inner sleeve110further includes a ring140extending from the cylindrical body134and having a larger outer diameter than the cylindrical body134and a plurality of projections142extending radially outward from the ring140—for example, at the first end136of the cylindrical body134. As described in further detail herein, the projections142are configured to restrict rotation of the inner sleeve110in the outer sleeve112during operation of the injector100. The inner sleeve110further includes a plurality of cam teeth144extending from the first end136of the cylindrical body134. The cam teeth144each include an angled face146(i.e., angled relative to the circumference of the cylindrical body134) configured to engage a cam face128of the cam elements126of the cam108during operation of the injector100to cause rotation of the cam108, as described in detail herein. As shown inFIGS. 8 and 9, the inner sleeve110further includes a plurality of ribs148extending radially inward from the cylindrical body134and extending longitudinally along the cylindrical body134. The ribs148locate and retain the syringe106in position when it is disposed within the cylindrical body134of the inner sleeve110. The inner sleeve110further includes a window150extending through the inner sleeve110that allows a user to view the contents of the syringe106before injection (e.g., after removal of the cap116). It is noted that the inner sleeve110illustrated inFIG. 37includes one or more of the same or similar features as the inner sleeve110illustrated inFIG. 6, and the inner sleeve110ofFIG. 37is provided to show that inner sleeve110may include any number of cam teeth144, such as six cam teeth, to correspond to the number of cam elements126of cam108.

The inner sleeve110further includes ridges152extending from the cylindrical body134at the second end138of the cylindrical body134. The ridges152each extend partially around the circumference of the inner sleeve110and include faces that are disposed at an acute angle with respect to a circumference of the cylindrical body134. As described in further detail herein, the ridges152allow for the connection of adapters to the injector100by engaging with threads of the adapters.

The inner sleeve110further includes a rib154extending from a front face156of the inner sleeve110and extending circumferentially around an aperture158through the front face156. The aperture158is configured to allow the passage of the needle of the syringe106therethrough during operation of the injector. As described in further detail herein, the rib154is configured to engage a diaphragm of an adapter coupled to the injector100to seal the inner sleeve110to the adapter.

FIG. 10shows a perspective view of the outer sleeve112, andFIG. 11shows a cross-sectional perspective view of the outer sleeve112. The outer sleeve112includes a cylindrical body160for housing the inner sleeve110, the cam108, and the syringe106. The cylindrical body160extends from a first end162to a second end164. The outer sleeve112includes a plurality of first ribs166and a plurality of second ribs168each extending inward from the cylindrical body160. The first ribs166extend from the second end164and toward the first end162, however, the first ribs166do not extend all the way to the first end162. As described further herein, this allows the cam108to rotate within the outer sleeve112at a specific stage of operation of the injector100, specifically at completion of injection of the medicament. The second ribs168are spaced apart from the second end164. As described in further detail herein, this allows the cam108to rotate within the outer sleeve112at a specific stage of operation of the injector100, specifically after removal of the injector100from the injection site and extension of the inner sleeve110. In various embodiments, the first166and second168ribs extend parallel to the longitudinal axis A of the injector100(shown inFIG. 3). The first ribs166define a shoulder170configured to engage the ring140on the inner sleeve110, when the inner sleeve110is extended, to locate the inner sleeve110.

The outer sleeve112further includes fingers172extending from the second end164of the cylindrical body160. A groove174is defined in the outside of the fingers172. The groove174is configured to receive a bead on the cap116to couple the cap116to the outer sleeve112, as described in more detail herein. The outer sleeve112also includes ramped projections176configured to engage the cap116when the cap116is in place on the injector100. The ramped projections176may extend outward from the cylindrical body160and along the outside of one or more of the fingers172. The ramped projections176may have surfaces that are inclined relative to the longitudinal axis of the outer sleeve112. As described in more detail herein, the inclined faces cause the cap116to be pushed outward, away from the first end162of the outer sleeve112when the cap116is twisted relative to the outer sleeve112. The fingers172can flex inward (toward the longitudinal axis A) during installation and removal of the cap116.

The outer sleeve112has apertures178at the first end162configured to receive teeth of the plunger102to couple the plunger102to the outer sleeve112, as described herein. The outer sleeve112also has ramps180at the first end162to provide a lead in for the teeth of the plunger102.

FIGS. 18A and 18Bshow perspective and cross-sectional side views, respectively, of the cap116. The cap116can include features that allow a user to grasp the cap116and remove it from the injector100. The cap116includes a bead182extending circumferentially around the inside of the cap116to engage the groove174in the outer sleeve112. The cap116defines recesses184extending into the end of the cap116and configured to receive the ramped projections176of the outer sleeve112. When the cap is twisted by a user, the sides of the recesses184contact the ramped projections176. This contact imparts an axial force on the cap116that pushes the cap116axially, way from the outer sleeve112to assist the user in removing the cap116from the injector100. The cap116has a boss186at its bottom end. The boss186includes a groove187that is configured to receive a portion of the needle cover engagement member114.

As shown inFIG. 19, the needle cover engagement member114includes a cylindrical body188and teeth190extending inward from the cylindrical body188. The teeth190are configured to engage the needle cover of the syringe106. The teeth190can be formed by pressing portions of the cylindrical body188inward, toward the center of the cylindrical body188. The needle cover engagement member114further includes feet192to engage the cap116to couple the needle cover engagement member114to the cap116. Specifically, the feet192engage the groove187in the cap116. Hence, the removal of the cap116also removes the needle cover from the syringe106.

FIG. 31shows a side view of the syringe106andFIG. 32shows a side cross-sectional view of the syringe106. The syringe106may be pre-filled with a medicament and includes a barrel194, a needle196, a needle cover198, and a plunger seal200. The barrel194can be a glass barrel, such as those constructed from straight cane glass. Alternatively, the barrel194can be constructed of a polymeric material. The barrel194can be coated with a material to reduce chemical interactions between the barrel194and the medicament. The needle196is mounted at the distal end of the barrel194and defines a lumen through which medicament can be delivered from the barrel194to the target site. The needle196can be attached to the barrel194using any appropriate method, such as staking and adhesives. The plunger seal200is disposed within the barrel194and is configured for axial translation within the barrel194. The plunger seal200can be constructed of an elastomeric material and provide a seal against the inner wall of the barrel194to maintain the sterility of the medicament prior to use.

FIG. 20shows a perspective view of the plunger102. The plunger102includes a cap portion202and a plunger rod204extending from the cap portion202. The plunger rod204can include a threaded portion205at the end opposite the cap portion202for engaging the plunger seal200of the syringe106. During assembly of the injector100, the plunger rod204is inserted through aperture130in the cam108and through the aperture158in the inner sleeve110so that the plunger rod204can engage the plunger seal200of the syringe106. The plunger102can further include one or more arms206extending from the cap portion202for engaging the apertures178in the outer sleeve112to lock the plunger102to the outer sleeve112, as shown inFIG. 2, for example. Each arm206can include an outwardly extending tooth208for engaging the aperture178. During assembly, each tooth208contacts a respective one of the ramps180on the outer sleeve112and the arm206flexes radially inward. When the tooth208reaches the aperture178the arm206flexes back toward its natural position such that the tooth208engages the aperture178. With the teeth208engaged with the apertures178, the plunger102is locked to the outer sleeve112such that they translate together during use, as described herein. As illustrated, for example, inFIGS. 20 and 21, the plunger102can further include a clip210extending from the cap portion202that can be used to clip the injector100to a belt or other item for ease of transportation and retrieval of the injector100. In another example, as illustrated inFIGS. 38 and 39, the plunger102can alternatively include an alligator clip211that can be used to clip the injector100to a belt or other item for ease of transportation and retrieval of the injector100. In some cases, the alligator clip211may be molded into a portion of the injector100. For example, an end213of the alligator clip211may be molded into the outer sleeve112of the injector, thereby securing the alligator clip211to the injector100. In some other cases, the alligator clip211may be removably coupled to the injector100. For example, the end213of the alligator clip211may include a ring-like structure that when placed on the outer sleeve112expands over the outer sleeve112and snaps around the surface of the outer sleeve112to fasten to the injector100. In such cases, the alligator clip211may be a separate component from the plunger102.

In some embodiments, as shown inFIG. 21, the cap116of the plunger102includes an indicator212that corresponds to the type of medicament contained in the syringe106. For example, the indicator212can be in the shape of a circle, an oval, a hexagon, a trapezoid, a heart, a star, or any other appropriate or desired shape.

The biasing member104can be, for example, a helical coil spring. However, it should be understood that the biasing member104can take on other forms. For example, the biasing member104can be a compressible, elastomeric component.

The operation of the injector100will now be described.FIGS. 1 and 2show side and side cross-sectional views, respectively, of the injector100in an initial configuration, which may be the configuration in which the injector100is provided to users. In this initial configuration, the cap116is in place on the injector100and is coupled to the outer sleeve112. Specifically, the ramped projections176on the outer sleeve112are disposed in the recesses184on the cap116and the bead182on the cap116is disposed in the groove174in the outer sleeve112. In addition, the teeth190of the needle cover engagement member114are engaged with the needle cover198of the syringe106. When the user is ready to use the injector100, the user can twist and/or pull the cap116with respect to the outer sleeve112to remove the cap116from the injector100. Removal of the cap116also removes the needle cover198due to the engagement of the teeth190with the needle cover198.

FIGS. 12A and 12Bshow side and side cross-sectional views, respectively, of the injector100after removal of the cap116. As can be seen in these figures, the inner sleeve110is extended, as a result of the force applied by the biasing member104, such that the inner sleeve110shields the needle196of the syringe106. As shown inFIG. 12B, the biasing member104is positioned such that one end of the biasing member104is in contact with the cap portion202of the plunger102and the opposite end of the biasing member104is in contact with the cam108. With the injector100in the configuration shown inFIGS. 12A and 12B, the biasing member104may be fully extended or nearly fully extended. As a result, the biasing member104is not imparting a large force on the inner sleeve110or the other components of the injector100. This allows the injector100to be stored for long durations without fear that components will be damaged or become permanently deformed as a result of being exposed to high forces during storage. This may provide an advantage over prior art devices that include springs or other biasing members that are in a compressed or loaded state during storage. The ring140of the inner sleeve110is in contact with the shoulder170of the outer sleeve112to prevent the inner sleeve110from falling out of the outer sleeve112.

FIG. 16Ashows an end view of the outer sleeve112, the inner sleeve110, and the cam108when the injector100is in the configuration shown inFIGS. 12A and 12B, andFIG. 17Ashows a cross-sectional perspective view of the same components in this configuration. The other components of the injector100are not shown for illustrative purposes. As shown inFIG. 34, the cam teeth144of the inner sleeve110are in contact with the cam elements126of the cam108. Any appropriate number of cam teeth144and cam elements126can be used. For example, in one embodiment, the inner sleeve110includes seven cam teeth144(as shown in, for example,FIG. 7) and the cam108includes seven cam elements126(as shown in, for example,FIG. 5A). In another example, in another embodiment, the inner sleeve110includes six cam teeth144(as shown in, for example,FIG. 37) and the cam108includes six cam elements126that correspond to the six cam teeth144. The angle that the interfacing surfaces (cam faces128and angled faces146) make with the longitudinal axis A can be chosen to provide the desired circumferential force on the cam108. For example, in one embodiment, these interfacing surfaces each define a helix angle of about 30 degrees with respect to the longitudinal axis A.

As shown inFIG. 33, the projections142of the inner sleeve110are disposed on opposite sides of respective first ribs166of the outer sleeve112, with this engagement preventing rotation of the inner sleeve110with respect to the outer sleeve112during use of the injector100. For example, projections142-1and142-2are positioned on opposite sides of first rib166-1. Each protrusion124of the cam108is positioned between a first rib166and a second rib168of the outer sleeve112. For example, as shown inFIGS. 16A and 17A, the protrusion124-1is positioned between first rib166-1and second rib168-1. The inner sleeve110can include more projections142than the cam108has protrusions124. As a result, the inner sleeve110can include a projection142on each side of each first rib166while the cam108has a protrusion124on only a single side of each first rib166.

When the user wishes to inject the medicament contained in the syringe106, the user brings the second end138of the inner sleeve110into contact with the injection site (i.e., the patient's tissue). With the inner sleeve110in contact with the injection site, applying pressure on the plunger102causes the outer sleeve112to translate toward the injection site and over the inner sleeve110, thereby compressing the biasing member104. As the outer sleeve112travels forward, the projections142of the inner sleeve110and the protrusions124of the cam108slide along the first ribs166and the second ribs168.

As the plunger102and the outer sleeve112translate forward, the syringe106is also moved forward as a result of the pressure applied by the plunger102on the plunger seal200. The forward movement of the syringe106causes the needle196to extend through the aperture158at the end of the inner sleeve110, as shown inFIGS. 13A and 13B, and be inserted into the injection site (i.e., the patient's tissue). The biasing member104is not shown inFIGS. 13 and 14for clarity, but it should be understood that the biasing member104would be present and compressed in these configurations. The syringe106moves forward until the flange194aat the end of the barrel194contacts the end of the ribs148in the inner sleeve110. With the flange194ain contact with the ribs148, further translation of the syringe barrel194with respect to the inner sleeve110is prevented and continued depression of the plunger102causes translation of the plunger seal200within the barrel194and injection of the medicament stored within the barrel194. This position is shown inFIGS. 14A and 14B. The length of the ribs148(i.e., the distance from the end of the ribs148to the front face of the inner sleeve110) can be chosen to provide the desired insertion depth of the needle196. Because the contact of the flange194aof the syringe barrel194with the ribs148controls the extent of the needle196that extends from the inner sleeve110, changing the length of the ribs148may change the depth of insertion. Changing the length of the ribs148may also be used to customize the injector100for use with different syringes106or needles196. This controlled depth of insertion provides advantages in controlling the depth of insertion to ensure the medicament is injected in the proper location (e.g., intramuscular injections).

When the end of the injection is reached (i.e., when the desired amount of medicament in the syringe106has been injected), the protrusions124of the cam108reach the end of the first ribs166. Once the protrusions124clear the first ribs166, the contact of the cam faces128of the cam elements126and the angled faces146of the projections142on the inner sleeve110causes the cam108to rotate. As can be seen by comparing the position of protrusion124-1inFIGS. 16A and 16Band inFIGS. 17A and 17B, the cam108has rotated counterclockwise. Rotation of the cam108causes each protrusion124to contact a respective one of the second ribs168(e.g., protrusion124-1contacts second rib168-2). This contact can provide audible (e.g., a “click”) and/or tactile feedback to the user that injection is complete (e.g., a clicking sound). The length of the first ribs166can be chosen to achieve the desired stroke of the plunger rod205—and, thereby, the plunger seal200—within the syringe barrel194. This ensures the proper amount of medicament is delivered prior to the audible or tactile indication that delivery is complete. The length of the first ribs166can be customized based on the length of the syringe barrel194. This may allow the injector100to be configured for different syringe sizes without modifying each of the components of the injector100. For example, the plunger102, the cam108, the inner sleeve110, and the cap116can be used with an outer sleeve112that has first ribs166customized to fit a particular syringe. This may reduce tooling costs and simplify and reduce the amount of inventory that a manufacturer must carry.

After completion of the injection, the user can begin to remove the injector100from the injection site. As the user does so, the inner sleeve110and cam108, under the urging of the biasing member104, travel back toward the second end164of the outer sleeve112to the position shown inFIGS. 15A and 15B. When the protrusions124of the cam108reach the end of the second ribs168, the contact of the cam faces128of the cam elements126and the angled faces146of the cam teeth144again causes rotation of the cam108. In this case, the cam108rotates such that the cam elements126move toward, and may come in contact with, the vertical faces147(shown inFIG. 7) of the cam teeth144. When the cam108comes to a stop, each protrusion124of the cam108is aligned and in contact with the end of a respective one of the second ribs168. For example, as shown inFIGS. 16C and 17C, protrusion124-1is aligned with and in contact with the end of second rib168-2. In this position, the cam108and inner sleeve110cannot translate axially within the outer sleeve112. Thus, the inner sleeve110and the outer sleeve112are locked in their positions. As a result, the inner sleeve110cannot be retracted and the needle196cannot again be exposed from the end of the inner sleeve110. This prevents inadvertent needle stick injuries that can occur with prior art injectors.

In another aspect, as shown inFIGS. 22-26, a Luer adapter300to be used with the injector100is provided. The Luer adapter300allows the medicament in the syringe106to be provided to a patient via, for example, an intravenous line. The Luer adapter300includes a body302having a cylindrical portion304and a tip306at one end of the cylindrical portion304. The cylindrical portion304defines a cavity308that is open at the end of the cylindrical body302that is opposite the tip306. The cavity308is configured to at least partially receive the injector100. The adapter300includes an interior wall310defining threads to engage the ridges152at the end of the inner sleeve110to couple the adapter300to the inner sleeve—for example, by way of a ¼ turn thread engagement.

At the end of the tip306, the adapter300includes a Luer connector314. The Luer connector314can be a male Luer connector for connection to a female Luer fitment of a tubing set. Alternatively, the Luer connector314can be a female Luer connector for connection to a male Luer fitment. The connection of the adapter300with the tubing set may, for example, use locking or slipping type Luer connections, such as those sold under the names LUER-LOK™ and LUER-SLIP™ by Becton Dickinson.

The adapter further includes a diaphragm316positioned within the tip306. The diaphragm316includes a frustoconical portion318and a flange320. The flange320is configured to be positioned between a shoulder of the adapter300and the inner sleeve110. The diaphragm316can be sealed by ribs on the inner sleeve (e.g., rib154) and the shoulder of the adapter300. During use, the frustoconical portion318of the diaphragm316is pierced by the needle196of the syringe106. The diaphragm316can be constructed from, for example, an elastomeric material. The diaphragm316is configured to ensure that the medicament is delivered though the Luer connector314and does not leak from the injector100or the Luer adapter300.

The connector314and the diaphragm316together define a channel322within which the needle196is at least partially disposed while the medicament is injected, as shown inFIG. 26.

The adapter300can further include finger flanges324extending outward from the cylindrical portion304. To deliver the medicament from the syringe106, the user can grasp the injector100with the user's fingers around the finger flanges324and with the cap portion202of the plunger102resting against the user's palm. The user can then squeeze to cause dispensing of the medicament. After dispensing the medicament, the user can release to allow the inner sleeve110to slide outward with respect to the inner sleeve110, as described above, such that the needle196is retracted from the diaphragm316. With the position of the inner sleeve110locked, the user can then remove the adapter300from the injector100and dispose of both the injector100and the Luer adapter300.

FIG. 25shows the adapter300coupled to the injector100. As shown, the second end138of the inner sleeve110is engaged with the diaphragm316and the needle196is disposed in the inner sleeve110.FIG. 26shows the injector100and the adapter300after depression of the plunger102and the outer sleeve112to extend the needle196and pierce the frustoconical portion318of the diaphragm316such that it is disposed in the channel322. With the needle196in this position, depression of the plunger102causes the medicament to be dispensed through tubing coupled to the Luer connector314.

In another embodiment, a nasal spray adapter400is provided for use with the injector100. The nasal spray adapter400allows the medicament in the syringe106to be provided to a patient via nasal delivery. The nasal spray adapter400includes a body402having a cylindrical portion404and a tip406at one end of the cylindrical portion404. The cylindrical portion404defines a cavity408configured to partially receive the injector100. The adapter400includes an interior wall410defining threads to engage the ridges152at the end of the inner sleeve110to couple the adapter400to the inner sleeve—for example, by way of a ¼ turn thread engagement.

At the end of the tip406, the adapter400includes an aperture412to allow medicament to be expelled into a user's nasal passages via a spray. The adapter400further includes a diaphragm416positioned within the tip406. The diaphragm416includes a frustoconical portion418and a flange420. The flange420is configured to be positioned between a shoulder of the adapter400and the second end138of the inner sleeve110. The diaphragm416can be sealed by ribs on the inner sleeve110(e.g., rib154) and the adapter400. During use, the frustoconical portion418of the diaphragm416is pierced by the needle196of the syringe106, as shown inFIG. 30, so that the medicament can be expelled through the aperture412. The diaphragm416can be constructed from, for example, an elastomeric material. The diaphragm416is configured to ensure that the medicament is delivered though the aperture412and does not leak from the injector100or the adapter400.

Further, as shown inFIG. 28an atomizing insert414can be positioned in the tip406adjacent to the aperture412. The atomizing insert414may convert the medicament into fine particles or droplets for delivery to the patient via the aperture412. The atomizing insert414is shown in more detail in the cross-sectional views ofFIGS. 29 and 30and inFIGS. 35 and 36. As shown inFIGS. 29 and 30, the atomizing insert414is positioned in the tip406between the diaphragm416and the aperture412.FIG. 36shows an exploded view of the atomizing insert414. The atomizing insert414may include an inner member430and an outer member432. The outer member432defines an inner passage436within which the inner member430is disposed.FIG. 36shows a perspective view of the inner member430. The inner member430may be substantially cylindrical and include one or more channels438extending longitudinally along the length of the inner member430. The channels438allow for the flow of medicament between the inner member430and the outer member432toward the aperture412. The inner member430may further include tracks440formed in the distal face442of the inner member. Each track440extends from a respective channel438toward a center of the inner member430. The tracks440may meet at the center of the distal face442adjacent to the aperture412. The tracks440may follow curved paths such that they impart a swirling motion on the medicament traveling toward the aperture412.

The adapter400can further include finger flanges424extending outward from the cylindrical portion404. To deliver the medicament from the syringe106, the user can grasp the injector100with the user's fingers around the finger flanges424and with the cap portion202of the plunger102resting against the user's palm. The user can then squeeze to cause dispensing of the medicament. After dispensing the medicament, the user can release to allow the inner sleeve110to slide outward with respect to the inner sleeve110, as described above, such that the needle196is retracted from the diaphragm416. With the position of the inner sleeve110locked, the user can then remove the adapter400from the injector100and dispose of both the injector100and the nasal spray adapter400.

The nasal spray adapter400allows for the medicament to be delivered intranasally, which avoids the need for an insertion of a needle into the patient, which may be preferable for some patients, specifically, those with a fear of needles or those with missing limbs or who lack adequate peripheral circulation. By delivering the medicament across the mucosal membrane, and to the patient's blood stream, the injector with nasal spray adapter400delivers an effective dose of delivery. This can be particularly useful for medicaments used to treat opioid overdoses, such as Naloxone.

In various embodiments, a kit is provided. The kit includes the injector100, the Luer adapter300, and the nasal spray adapter400. By providing the nasal spray adapter400and the Luer adapter300, the medicament can be delivered either via the spray nozzle to the mucosal membranes, intravenously using the Luer adapter300, or via the needle intramuscularly, subcutaneously, intraosseously, or at any other appropriate depth. This provides the user or patient with the option at time of delivery, allowing them to choose the method of delivery which is more comfortable or most effective for them.

In another embodiment, a method of operating an injector is provided. The method includes removing a cap from the injector. The method includes placing an end of an inner sleeve against the target location. With the injector in place, a force is applied to an outer sleeve. Applying the force to the outer sleeve (i) causes axial translation of the outer sleeve and a syringe relative to the inner sleeve, (ii) causes a needle of a syringe to extend out from the distal end of the inner sleeve and into the target location, and (iii) causes the flange on the syringe barrel to contact a rib on the inner sleeve. Subsequently, a continued force is applied to the outer sleeve and plunger. Applying the continued force to the outer sleeve causes translation of a plunger rod and a seal within the syringe to cause delivery of the medicament. After delivery of the medicament, the injector is removed from the target location. A biasing member applies a force on the inner sleeve to cause the inner sleeve to translate in the distal direction with respect to the outer sleeve to cover the needle of the syringe such that the inner sleeve is locked in place with respect to the outer sleeve.

In another embodiment, a method of using an injector and a nasal spray adapter to deliver a medicament intranasally is provided. A cap of the injector is first removed. The nasal spray adapter is engaged with the injector. A tip of the nasal spray adapter is placed within or adjacent to a nostril of the patient. An outer sleeve of the injector is translated toward the tip of the nasal spray adapter to expel the medicament through the tip of the nasal spray adapter and to the patient.

In another embodiment, a method of using an injector to deliver a medicament intravenously is provided. A cap of the injector is first removed. A Luer adapter is connected to the injector. The Luer adapter is coupled to a tubing set. An outer sleeve of the injector is translated toward the Luer fitment to deliver the medicament through the Luer connector, through the tubing set, and to the patient.

While the foregoing description and drawings represent preferred or exemplary embodiments of the present invention, it will be understood that various additions, modifications and substitutions may be made therein without departing from the spirit and scope and range of equivalents of the embodiments described herein. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other forms, structures, arrangements, proportions, sizes, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. In addition, numerous variations in the methods/processes described herein may be made without departing from the spirit of the invention. One skilled in the art will further appreciate that the invention may be used with many modifications of structure, arrangement, proportions, sizes, materials, and components and otherwise, used in the practice of the invention, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention.