KR20150126657A - Re-useable injector device for syringe - Google Patents

Re-useable injector device for syringe Download PDF

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Publication number
KR20150126657A
KR20150126657A KR1020157027577A KR20157027577A KR20150126657A KR 20150126657 A KR20150126657 A KR 20150126657A KR 1020157027577 A KR1020157027577 A KR 1020157027577A KR 20157027577 A KR20157027577 A KR 20157027577A KR 20150126657 A KR20150126657 A KR 20150126657A
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KR
South Korea
Prior art keywords
housing
assembly
injector device
syringe
outer housing
Prior art date
Application number
KR1020157027577A
Other languages
Korean (ko)
Other versions
KR101780191B1 (en
Inventor
토비 코위
Original Assignee
테바 파마슈티칼 인더스트리즈 엘티디
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Priority claimed from US13/790,487 external-priority patent/US8652100B1/en
Priority claimed from CA2808875A external-priority patent/CA2808875A1/en
Priority claimed from EP13158407.0A external-priority patent/EP2774639B1/en
Application filed by 테바 파마슈티칼 인더스트리즈 엘티디 filed Critical 테바 파마슈티칼 인더스트리즈 엘티디
Publication of KR20150126657A publication Critical patent/KR20150126657A/en
Application granted granted Critical
Publication of KR101780191B1 publication Critical patent/KR101780191B1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/202—Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2418—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for damping shocks on ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2492—Ampoule holder connected to rest of syringe via snap connection

Abstract

The injector device includes an injector body for receiving the injector; And an injection assembly configured to dispense the medicament from the syringe at a dispensing step. Certain types of injection devices include a rapid completion indicator that indicates when the injection is complete. Certain types of injector devices are configured to dispense two different pharmaceutical agents having different viscosities from a syringe without any change to the injector devices without altering the syringes. Certain types of injector devices include safety devices that inhibit the firing of the injector device until the front and rear housing assemblies are positioned at predetermined rotational and axial positions relative to one another.

Figure P1020157027577

Description

≪ Desc / Clms Page number 1 > RE-USEABLE INJECTOR DEVICE FOR SYRINGE &

The medicament may be dispensed from the syringe using an injector device. Some injector devices are spring-loaded so the user only needs to trigger the trigger to dispense the drug. Certain types of injector devices also automatically inject the needle into the injection site prior to dispensing the drug. For example, certain types of injector devices start to operate when the forward of the injector device is pushed against the injection site. Certain types of injector devices are "one-shot" devices. Other types of injector devices are configured to be reused by allowing the used syringe to be switched out to a replacement syringe. Certain types of injector devices include an indicator that provides an indication of how many times the injector device has injected the drug or how many drugs have been dispensed.

According to some aspects of the present disclosure, an injector device includes a first housing assembly configured to hold a syringe; A second housing assembly; A locking member; And an interlocking assembly configured to rotatably attach the first housing assembly to the second housing assembly in a specific rotational position. The second housing assembly includes an outer housing and an inner housing. The inner housing is configured to be axially fixed relative to the first housing assembly. The outer housing is configured to move axially relative to the first housing assembly between an extended position and a retracted position. The second housing assembly includes an injection assembly configured to actuate a syringe to inject a medicament from the syringe. The second housing assembly includes a trigger member configured to fire the injection assembly only when the outer housing is in the retracted position. The second housing assembly includes a biasing member that biases the outer housing to an extended position. The locking member securely holds the outer housing in the extended position. The interlocking assembly is configured to release the locking member such that the outer housing is retracted relative to the first housing assembly in a retracted position against deflection of the deflection member.

According to other aspects of the present disclosure, an injector device includes an injector body including a front assembly and a rear assembly that cooperate to form an interior; syringe; And an injection assembly disposed within the interior of the syringe body. The front assembly includes a front housing, a syringe carrier movable between a rearward position and a forward position relative to the front housing, a first damper disposed rearward of the front housing, and a second damper disposed rearward of the syringe carrier. The syringe carrier engages the first damper when in the forward position and the syringe carrier is spaced from the first damper when in the back position. The syringe is configured to be coupled to the syringe carrier for movement with the syringe carrier. The syringe includes an ampoule, a needle, and a plunger. The needle extends from the first end of the ampoule and the plunger extends from the second end of the ampoule. At least a portion of the ampoule engages the second damper. The ampoule is configured to hold a common volume of any one of the two or more different pharmaceutical agents in the injector device without modification. The first of the two different pharmaceutical agents has a first viscosity and the second of the two different pharmaceutical agents has a second viscosity different from the first viscosity. The injector assembly is configured to dispense the drug formulation held by the syringe. The injector assembly includes a ram driven by a constant load spring. The release of the constant force spring drives the syringe carrier from the rearward position to the forward position until the syringe carrier engages the first damper. The constant force spring drives the plunger within the ampule of the syringe after the syringe carrier is positioned in the forward position. The first and second dampers cooperate to prevent damage to the ampoule during movement of the syringe carrier and plunger movement.

According to certain aspects of the present disclosure, the injector device includes a sudden completion indicator member disposed within the interior of the injector body. The quick completion indicator member is configured to move between a first position and a second position with respect to the injector body. The rapid completion indicator member is visible through the window in the injector body when in the first position and through the window when in the second position. The movement of the rapid completion indicator member from the first position to the second position is activated upon completion of the dispensing step.

Additional aspects of the various aspects of the invention will be set forth in the detailed description which follows. Aspects of the present invention may relate to individual features and combinations of features. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention's inventive concepts, on the basis of the disclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate several aspects of the present disclosure. A brief description of the drawing is as follows:
1 is a front perspective view of an exemplary injector apparatus constructed in accordance with the principles of the present disclosure;
Figure 2 is a front perspective view of the injector device of Figure 1 with the lid remover removed from the injector device;
Figure 3 is an exploded view of the injector device of Figure 1;
Figure 4 is a side view of the injector device of Figure 1 with the front assembly separated axially from the rear assembly;
Figure 5 is an axial cross-sectional view of the injector device of Figure 4 with the front assembly flipped to face the rear assembly;
Figure 6 is a side view of the injector device of Figure 4 with the front end of the front assembly inserted into the front end of the rear assembly to mount the injection system of the injector device;
Figure 7 is an axial cross-sectional view of the injector device of Figure 6;
Figure 8 is an axial cross-sectional view of the front assembly of the injector device of Figure 1 shown with the syringe loaded into the front assembly;
Figure 9 is an enlarged view of a cross section of the forward end of the injector device of Figure 1 with the syringe loaded so that the cover remover of the front assembly engages the needle cover;
Figure 10 shows a lid remover and needle cover removed from the injector device of Figure 9;
11 is a side view of the front assembly of FIG. 10 with the syringe loaded therein and the lid remover removed;
Figure 12 is a perspective view of the rear assembly of Figure 4, shown in axial cross-section and separated from the front assembly;
Figure 13 is a side view of the injector device of Figure 1 disposed in an extended position of the rear housing;
Figure 14 is a side view of the injector device of Figure 13, with the rear housing disposed in a retracted position;
Figure 15 is an axial cross-sectional view of the injector device of Figure 13;
Figure 16 is an axial cross-sectional view of the injector device of Figure 14,
Figure 17 is a perspective view of the inner housing of the rear assembly that is positioned relative to the illustrated front assembly away from the outer housing of the rear assembly so that the interlocking arms and the rearwardly extending tabs are visible;
18 is an enlarged perspective view of a portion of Fig. 17;
Figure 19 is a rear perspective view of the front assembly of Figure 16 showing a lateral cross-section of the interlocking arm;
20 is a perspective view of a trigger button disposed about the ledge structure of the inner housing;
FIG. 21 is an axial cross-sectional view of the injector device of FIG. 16 wherein the trigger button is depressed and the ram of the injection assembly is released from the cocked position and the syringe carriage is bottomed out;
22 is an axial cross-sectional view of the injector device of FIG. 21 with the plunger fully withdrawn from the syringe and a rapid completion indicator located in the forward position;
Figure 23 is a perspective view of the injector device of Figure 2, in which the needle of the injector projects from the front of the injector device and the completion indicator is located in the forward position.

DETAILED DESCRIPTION OF THE INVENTION Reference will now be made in detail to the exemplary aspects of the present disclosure illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

In general, the present disclosure relates to an injector device configured to hold a syringe and an injection assembly. The injection assembly is configured to dispense the drug from the syringe (i.e., to release fluid from the syringe) in a dispensing step. In some embodiments, the injection assembly is also configured to move the syringe from the retracted position to the extended position to inject (i.e., insert the needle into the injection position) into the syringe in the injection step. In certain embodiments, the injector device is reusable. For example, the syringe can be removed after use and replaced with a new syringe.

According to some embodiments, the injector device has a completion indicator indicating that the medicament has been dispensed and the user can withdraw the needle from the injection position. In certain embodiments, the completion indicator is a quick completion indicator. For example, the completion indicator only operates at the completion of the distribution step. As used herein, the term " at completion "refers to a time including a moment of completion, a time immediately after completion, a time within a few milliseconds before and after completion (i.e., Quot;). The display provided by the quick completion indicator is not changed until the dispensing is complete. In some implementations, the quick completion indicator includes a window and a color change is visible through this window when the distribution is complete. In certain implementations, the expedited completion indicator includes an audible tone that is generated when distribution is complete. In certain implementations, the quick completion indicator includes both a color change and an audible tone.

According to some embodiments, the injector device is configured for use with syringes that can have any one of two or more different formulations. The formulation used in the syringe can be switched between the two formulations without adjustment to the injector device. For example, the injector device may be used with a first syringe having a special medication of 20 milligrams in a particular volume. The first syringe can be replaced with a second syringe containing 40 milligrams of the drug in the same volume after injection. The injector device may be injected and dispensed into the second syringe without any adjustment to the injector device.

The same injector device may receive either the first or second syringe. For example, the sizes of the first syringe and the second syringe may be substantially the same. Parts of the injector device need not be modified to switch to a formulation that is scaled or moved or otherwise being loaded. For example, the same constant load spring, the same ram arrangement and the same plunger depth can be used with both syringes. Thus, prior to each injection, the user may select whether to inject the injector device with either the first or second agent. The syringe carrier and the damping zones on the carrier holder suppress the breakage of the syringe during scanning and dispensing. For example, the damping zones may be damaged by syringe breakage during injection (e.g., cracking, breaking, and / or fracturing of the ampoule, deformation or displacement of the needle hub relative to the ampule, Or other impairments). ≪ / RTI >

According to some embodiments, the injector device includes safety devices that precisely assemble the injector device and press it against the injection position in a predetermined amount of force and inhibit the firing of the injector device until the trigger is actuated. For example, even when the trigger button of the injector device is depressed when a predetermined amount of force is not applied to the injector device, the injection assembly will not operate to inject into the syringe or dispense the drug. In some embodiments, the injector device includes a front assembly and a rear assembly, which are rotationally aligned and axially moved toward each other before the trigger will trigger the injection assembly.

 Figures 1 and 2 illustrate an exemplary injector device 100 extending between a front face 101 and a rear face 102. The injector device 100 has opposing side surfaces 103 that extend between the front side 101 and the back side 102. Generally, the injector device 100 is configured to dispense medicament from the frontal surface 101 when triggered at the rear surface 102. The injector device 100 also has opposing end surfaces 104 extending between the side surfaces 103 and between the front 101 and the back side 102. In some embodiments, the side surfaces 103 have a greater lateral dimension than the end surfaces 104. [

 The injector device 100 includes a front assembly 110 and a rear assembly 130 that are coupled to each other. The front assembly 110 is configured to hold the syringe 180 (Fig. 8). The rear assembly 130 is configured to hold the injection assembly 140 (FIG. 12). In some embodiments, the front and rear assemblies 110, 130 may be releasably coupled together to provide for the entry and exit of the injector apparatus 100 into and out of the injector apparatus 100. For example, the front assembly 110 can be threaded, latched, snapped, frangibly or otherwise releasably coupled onto the rear assembly 130. Release of the front assembly 110 from the rear assembly 130 allows the user to replace the syringe in the front assembly 110. [

As shown in Figure 3, the front assembly 110 includes a syringe carrier 111 configured to be slidably mounted within the carrier support 114 between a forward position and a rearward position. The syringe carrier 111 is configured to hold the syringe 180 (Fig. 8) so that the front of the syringe 180 extends forward of the carrier 111 (see, e.g., Fig. 10). When the syringe carrier 111 is in the backward position, the syringe 180 does not protrude from the front surface 101 of the injector device 100 (see, e.g., Fig. 15). When the syringe carrier 111 is in the forward position, the syringe (i.e., at least a portion of the needle 185) protrudes from the front surface 101 of the injector device 100 (see, e.g., Fig. 21). The carrier spring 116 deflects the syringe carrier 111 toward the rearward position. In particular, the first end of the carrier spring 116 abuts and abuts against the hub 113 of the syringe carrier 111 and the second end of the spring 116 abuts against the interior shoulder within the carrier support 114 Touch. An intermediate portion of the carrier spring 116 extends over the support section 112 of the syringe carrier 111. [

In some embodiments, damper device 190 is provided on syringe carrier 111 and carrier support 114 to inhibit fracture of syringe 180 (FIG. 8) during injection and dispensing Reference). For example, the damper device 190 may be positioned within the syringe 180 when the syringe 180 is advanced within the front assembly 110 and / or when the plunger 182 (Fig. 8) Thereby reducing the risk of breakage. In some embodiments, the damper device 190 includes one or more dampers disposed on the front housing assembly 110 and / or the syringe carrier 111. In various embodiments, the dampers are formed of an elastic material such as rubber, foam, or gel.

In some embodiments, the first damper 192 is positioned at least on a rearward facing surface of the carrier support 114 (Figure 7). The first damper 192 is configured to engage the syringe carrier 111 when the syringe carrier 111 is in the forward position. The first damper 192 absorbs energy from the syringe carrier 111 when the syringe carrier 111 reaches the rearward position. Accordingly, the first damper 192 suppresses the transfer of energy to the syringe 180. In some embodiments, a second damper 196 is disposed on the syringe carrier 111 to engage the syringe 180 (FIG. 7). The second damper 196 cooperates with the first damper 192 to urge the syringe 180 (e.g., the syringe 180) when the syringe carrier 111 engages the carrier support at the forward position and / or when the syringe plunger is fully depressed within the syringe 180. [ ).

In some embodiments, the first damper 192 includes one or more gasket sections disposed on the carrier support 114 and facing the syringe carrier 111. In other embodiments, the first damper 192 is also a portion of the gripping member 194 that extends over the outer surface of the front assembly 110 (FIG. 5). In certain embodiments, the gripping member 194 is a soft / elastic / compressible material (e.g., rubber) that is over-molded or otherwise formed on the exterior of the carrier support 114. In some embodiments, the second damper 196 includes a gasket ring disposed in the through-passageway of the syringe carrier 111. In certain embodiments, at least a portion of the second damper 196 is seated on a rearward facing surface of the syringe carrier 111. The rear end of the syringe 180 rests on the second damper 196 (Fig. 9).

The front assembly 110 also includes a depth adjustment assembly that controls the distance the needle 185 (FIG. 10) of the syringe 180 protrudes from the front surface 101 of the injector device 100 during injection. Referring again to FIG. 3, the depth adjusting assembly includes a depth adjuster 117 disposed within a depth adjuster housing 122 that couples to a carrier support 114. For example, the depth adjuster 117 may form external threads 118 that engage internal threads 123 of the housing 122 (FIG. 3). In some embodiments, the latch arms 119 of the depth adjuster 117 may interact with the notched inner surface 115 (Figure 3) of the carrier support 114 to allow the depth adjuster 117, respectively. Each distinct rotation position corresponds to a different needle depth. In other embodiments, a notched inner surface may be provided on the regulator housing 122. [

The display portion 121 (Figs. 1 and 2) is provided on the outer surface of the depth adjuster 117 to indicate how far the needle is projected and set. For example, a series of numbers representing the length or distance may be arranged in a spiral pattern around the outer periphery of the depth adjuster 117. The regulator housing 122 forms a window 124 through which the depth adjuster 117 is visible (FIG. 1). When the depth adjuster 117 is screwed along the regulator housing 122, the display portions 121 are circulated under the window 124. In some implementations, the display portions 121 are spaced apart to correspond to distinct rotational positions formed by the notched inner surface 115 of the carrier support 114. For example, in some embodiments, the new display portion 121 is visible through the window 124 at each rotational position of the depth adjuster 117. In other embodiments, the new display 121 appears at predetermined rotational positions. In some embodiments, the display portions 121 are large enough to facilitate reading of the display portion 121 by the user. For example, at least a part of the display portion 121 may be 4 mm in height.

The depth adjuster 117 forms a gripping surface 120 (FIG. 2) facing the front face 101 of the injector device 100. To adjust the depth of the syringe needle, the user grasps the gripping surface 120 of the depth adjuster 117 and rotates the depth adjuster 117 clockwise or counterclockwise. Movement in one direction increases the depth of the needle by moving the depth adjuster 117 backward with respect to the adjuster housing 122. Movement in the other direction reduces the depth of the needle by moving the depth adjuster 117 forward relative to the adjuster housing 122.

The cover remover 125 is configured to mount on the front 101 of the injector apparatus 100 (FIG. 1). The cover remover 125 covers the gripping surface 120 of the depth adjuster 117 when mounted on the front assembly 110 (see, e.g., Fig. 8). The cover remover 125 is configured to be fixed to the regulator housing 122 without being fixed in the direction of rotation relative to the depth adjuster 117. The rotational movement of the cover remover 125 does not cause the rotational movement of the depth adjuster 117. [ The axial movement of the cover remover 125 also does not cause axial movement of the depth adjuster 117. Rather, the axial movement of the lid remover 125 in front of the depth adjuster 117 removes the lid remover 125 from the regulator housing 122 (see, e.g., Fig. 10). The cover remover 125 is configured to remove the cover 186 covering the needle 185 of the syringe 180 (see FIG. 10). Thus, the syringe 180 can be mounted to the front assembly 110 while the lid 186 covers the needle 185 (see FIG. 8). The lid remover 125 facilitates removal of the lid 186 without the possibility of contact between the user and the needle 185.

As shown in FIG. 9, the lid remover 125 includes an outer wall 126 having a size that fits around the outer periphery of the lid adjuster 117. The outer latch arms 127 extend rearward from the outer wall 126 and are fixed to the regulator housing 122 (Fig. 9). The lid remover 125 also includes an inner wall 128 having a size that fits within the depth adjuster 117 and around the needle lid 186 (see FIG. 9). The inner latch arms 129 extend rearward from the inner wall 128 to catch the edges of the needle cover 186. The cover remover 125 is removed from the front assembly 110 by unlatching the outer latch arm 127 by pulling the cover remover 125 forward with sufficient force to the front assembly 110 (see FIG. 10). The inner latch arm 129 carries or transports the needle cover 186 when the lid remover 125 is moved away from the front assembly 110 (see FIG. 10).

3, the rear assembly 130 includes an outer housing device 131, an injection assembly 140, an inner housing 150, and a triggering device 170. As shown in FIG. In some embodiments, the rear assembly 130 includes an interlocking device 160 that connects the rear assembly 130 to the front assembly 110 (see, e.g., FIG. 15). The interlocking device 160 is shown in more detail herein as an injector device 100 in which the injector assembly 140 can not be actuated (see Figures 13 and 15) and the injector assembly 140, (See Figs. 14 and 16) in which the first and second actuators can be actuated. In some embodiments, the rear assembly 130 includes an indicator assembly 175 (FIG. 3) that provides a completion indicator as described in more detail herein.

The inner housing 150 of the rear assembly 130 includes a hollow body 151 having an open end and a closed end (see FIGS. 12 and 17). The open end forms part of the interlocking device 160 (Fig. 12). The closed end is formed by the ceiling structure 154 and the rezzing device 152 extends rearward from this ceiling structure (Fig. 17). The rest device 152 forms one or more rearward facing shoulders positioned in a rearwardly spaced apart position from the ceiling structure 154 (FIGS. 17 and 21). In one exemplary embodiment, the rest device 152 includes two rearward facing shoulders. The guiding structure 153 extends rearward of the rest device 152 (Figs. 12 and 17).

3, the injection assembly 140 includes a ram 141 and a constant load spring 149 that deflects the ram 141 toward the front face 101 of the injector device 100. As shown in FIG. At least a portion of the ram 141 is disposed within the inner housing 150 between the open end and the closed end. The ram 141 is configured to move (e.g., slide) within the inner housing 150 between at least the cocked position (FIG. 7) and the "bottomed out" The ram 141 is positioned at the closed end of the inner housing 150. When in the withdrawn position the ram 141 is positioned at the closed end of the inner housing 150, The ram 141 may be positioned forward of the inner housing 150 when in its maximum withdrawal position.

 The ram 141 forms an abutment surface 142 facing the front surface 101 side of the injector device 100 (FIG. 3). The abutment surface 142 is configured to push in contact with the plunger 182 of the syringe 180 as it moves toward the maximum withdrawn position (see Figures 21 and 22). In one exemplary embodiment, the bonding surface 142 is flat (see FIG. 5). In some embodiments, the abutment surface 142 is spaced from the plunger 182 when the ram 141 is in the retracted position (see Figs. 15 and 16).

The ram 141 also includes a latch arm 144 that extends through the hole in the ceiling structure 154 to the rest device 152 (see FIG. 12). The latch arms 144 form latching lugs 145 that are configured to rest on the rearwardly facing shoulders of the rest device 152 to releasably secure the ram 141 in the retracted position in the retracted position (For example, see Fig. 20). The lugs 145 of the latch arm 144 are configured to hold the ram 141 against the deflection of a constant load spring 149 to hold the ram 141 in the retracted position.

The ram 141 also forms a spring support section 143 (FIG. 3) at an intermediate position between the engagement surface 142 and the latch arm 144. 3) is mounted to spring support section 143 and a constant force spring 149 is wrapped or otherwise mounted around barrel 148 (see, for example, Fig. 12 Reference). The opposite end of the spring 149 is clamped or fastened or otherwise secured between the inner housing 150 and the interlocking device 160 (see FIG. 12).

The outer housing arrangement 131 includes a rear outer housing 132 that receives the inner housing 150 (see FIG. 3). The trigger arrangement 170 is mounted at the rear end of the rear outer housing 132 (see FIG. 3). In some embodiments, the triggering device 170 includes a forwardly extending latch arm 172 (Figs. 3 and 20) snapped-in or otherwise secured to the inner shoulders formed by the rear outer housing 132, (For example, see Fig. 7). The button 171 protrudes rearward from the rear outer housing 132 (see, e.g., Fig. 7).

Button 171 is actuated relative to the rear outer housing 132 between the ready position (e.g., see FIG. 5) and the depressed position (see FIG. 12, for example). The button 171 is further disposed in the rear outer housing 132 when in the depressed position than when in the ready position. The trigger spring 174 deflects the button 171 to its starting position (see FIG. 5). A ramped structure 173 extends forward along the hollow interior of the button 171 (Figs. 12 and 20). Causing the ramp type structure 173 to move forward relative to the rear outer housing 132 by moving the button 171 from the ready position to the depressed position against the bias of the trigger spring 174. [

 In some embodiments, an indicator assembly 175 may be disposed between the inner housing 150 and the rear outer housing 132 (see FIGS. 3, 12, and 22). The indicator assembly 175 includes an indicator body 176 (see FIG. 3). In some embodiments, the indicator body 176 includes a colored surface. In other embodiments, the indicator body 176 includes a surface on which the indicia is printed. In some embodiments, the indicator body 176 also includes a track follower 178 that extends radially inward from the body 176 to interact with the inner housing body 151 22).

 The indicator body 176 is configured to slide along the exterior of the inner housing body 151 between a rearward (i.e., restrained) position (FIG. 21) and a forward (i.e. biased) position (FIG. 22). The biasing member (i.e., indicator spring 179) biases the indicator body 176 toward the forward position. In some embodiments, one or more of the tracks 156 or cuts extend longitudinally along the peripheral wall of the hollow body 151 of the inner housing 150 (Fig. 17). In certain embodiments, the track follower 178 of the indicator body 176 is configured to extend and slide along one of the tracks 156 to inhibit rotational movement of the indicator body 176 (FIG. 12). In some embodiments, the track follower 178 can be used to reset the indicator member 176 during priming of the injection assembly 140 as described in more detail herein.

The indicator body 176 is held against the bias of the indicator spring 179 by a stop 158 (Figs. 17 and 20) provided on the inner housing 150. Fig. The stops 158 are disposed on one or more flexible arms 157 that extend into one or more of the cuts in the hollow body 151 (see FIG. 17). In some embodiments, the arms 157 are configured to bend radially inward toward the interior of the hollow body 151. The stop members 158 extend outwardly from the flexible arms 157. The indicator spring 179 is strong enough to push the indicator body 176 over the stop members 158 thereby pressing the stop member 158 into the interior of the inner housing 150 into the incision 22). However, when the ram 141 is placed in the retracted position in the inner housing 150 (see, for example, FIG. 21), the ram 141 is moved inwardly of the stop member 158 . Thus, the stop member 158 holds the indicator body 176 against the bias of the indicator spring 179 until the ram 141 is moved to the deflected position.

The rear outer housing 132 forms one or more window apertures 133 (Figure 3) through which the indicator body 176 is visible when the indicator body 176 is in the forward position (e.g., 23). The indicator body 176 is not visible through the window aperture 133 when the indicator body 176 is in the rearward position (see, e.g., Fig. 1). In one embodiment, the rear housing 132 forms a window aperture 133 on only one of the side surfaces 103 of the housing 132. The rear housing 132 forms a window aperture 133 in both side surfaces 103 of the housing 132 and the indicator body 176 forms two indicator bodies 176. In other embodiments, In certain embodiments, the window arrangement 134 (FIG. 3) may be tightly disposed within the rear outer housing 132 in the window aperture 133. The window arrangement 134 is formed of a transparent or semi-transparent material that fills the aperture 133 to protect the interior of the injector device 100.

The outer housing arrangement 131 also includes an intermediate outer housing 137 that is assembled with a rear outer housing 132 (see Figure 3). The intermediate outer housing 137 defines a support structure 138 that extends inwardly from the inner surface of the middle outer housing 137 (see FIG. 12). The support structure 138 forms a forward facing shoulder 139 (Fig. 12).

In some embodiments, one or both of the housings 132, 137 include gripping surfaces 135, 137, respectively, to facilitate gripping of the injector device 100 (see FIG. 1). In some embodiments, the gripping surfaces 135,137 extend over at least a portion of the outer flat surfaces of the housings 132,137. In certain embodiments, the gripping surfaces 135,137 are formed of a compressible material. In one exemplary embodiment, the gripping surfaces 135, 137 are formed of rubber.

The interlocking locking arrangement 160 couples the front assembly 110 to the rear assembly 130 (see FIG. 15). The interlocking locking arrangement 160 includes an interlocking body 161 that forms internal threads 162 at the front end (Figs. 3 and 12). The rear end of the interlocking body 161 is configured to attach to the inner housing 150 (Figure 12). The internal screw 162 has a size that engages an external screw 163 disposed on the carrier support 114 (see FIG. 11) to releasably couple the rear assembly 130 to the front assembly 110.

In some embodiments, internal threads 162 and external threads 163 are configured to facilitate rapid threading of the front and rear assemblies 110, 130. For example, in certain embodiments, each of the internal threads 162 and external threads 163 extend approximately two or less of the inner circumference of the respective assembly 110, 130 (Figs. 11 and 12) 12). In certain embodiments, each of the internal threads 162 and external threads 163 extend about the inner circumference at about one time and less than two times. In certain embodiments, inner threads 162 and outer threads 163 each extend approximately one or less times the inner periphery of each assembly 110,130. In certain embodiments, each of the inner and outer threads 162, 163 extend about half the inner circumference of the respective assembly 110, 130.

As shown in FIG. 12, the inner housing 150 is configured to releasably lock to the intermediate outer housing 137. The inner housing 150 defines an interlocking arm 155 extending forward of the stationary shoulder 164. The interlocking arm 155 includes a flexible arm configured to deflect inward relative to the rest of the inner housing 150 (see FIG. 15). The interlocking portion 155 includes a latching hook extending radially outwardly from the arm 155 to form a rearward facing shoulder 159 (FIG. 12). The free end of the interlocking arm 155 forms a ramped or contoured surface 169 that tapers or curves laterally across the arm 155 (see FIGS. 18 and 19).

When the rear outer housing 132 and the middle outer housing 137 are mounted on the inner housing 150, the support member 138 of the middle housing 137 engages with the fixed shoulder 164 of the inner housing 150, And is disposed between the rearward-facing shoulders 159 of the rear portion (FIG. 12). Thus, the outer housing assembly 131 is held stationary relative to the inner housing 150 and the mutual locking body 161. A portion of the interlocking body 161 (e.g., a band) extends between the front assembly 110 and the rear assembly 130 (see FIG. 13).

FIGS. 4-7 illustrate how the injector apparatus 100 is mounted (i.e., how the ram 141 (FIG. 3) moves from its maximum withdrawn position to its retracted position). As shown in FIG. 4, the front assembly 110 is removed from the rear cooking utensil 130 (e.g., by unscrewing the carrier support 114 from the interlocking body 161). As shown in FIG. 5, the front assembly 110 is flipped so that the lid remover 125 faces the rear assembly 130. 6 and 7, the front end of the front assembly 110 is inserted into the rear assembly 130 and slid rearward within the inner housing 150. As shown in FIG.

The front end of the front assembly 110 engages the ram 141 and pushes the ram 141 rearward within the inner housing 150 toward the ceiling structure 154 (see FIG. 6). For example, in some embodiments, the cover remover 125 is pressed against the abutment surface 142 of the ram 141. In other embodiments, the depth adjuster 117 is pressed against the bonding surface 142. The ram 141 is moved backward against the deflection of the constant force spring 149. [ The ceiling structure 154 prevents the ram 141 from moving too far backward. Since the ram 141 is moved rearwardly, the latch arm 144 is locked to the ceiling structure 154 until the latch lugs 145 are resting on the rear shoulder of the ledge arrangement 152 at the retracted position (see Fig. 20) And moves toward the rear-aligning body 152.

  FIGS. 8-11 illustrate mounting the syringe 180 into the front assembly 110. FIG. The syringe 180 includes an ampoule 181 configured to hold the medicament. The plunger 182 extends to the piston or bung 183 which seals the medicament in the ampule 181 through the rear end of the ampule 181. Needle 185 (FIG. 10) couples to needle hub 184 at the front end of ampule 181. The lid 186 surrounds the needle 185 (see, e.g., Fig. 9). The cover 186 prevents the person handling the syringe from being stuck or stuck by the needle 185 by chance.

As shown in FIG. 8, the syringe 180 is inserted into the rear end of the front assembly 110. The covered end of the syringe 180 is inserted through the syringe carrier 111 so that the support section 112 of the carrier 111 surrounds a portion of the ampule 181 (e.g., see Figs. 9 and 10) . The syringe 180 is inserted far enough into the front assembly 110 so that the needle cover 186 extends from the inner walls 128 of the lid remover 125. The latch arms 129 of the inner walls 128 are hooked to the ends of the lid 186 or otherwise secured onto the ends of the lid (see FIG. 9).

10, when the lid remover 125 is pulled to the front of the front assembly 110, the lid remover 125 is engaged with the lid 186, thereby removing the lid 186 from the needle 185 Remove. As shown in Fig. 11, the gripping surface 120 of the depth adjuster 117 is accessible when the lid remover 125 is removed. The plunger 182 extends rearward of the ampule 181 and the front assembly 110 when the syringe is mounted on the syringe carrier 111.

12 illustrates a cross-sectional view of the rear assembly 130 after the injection assembly 140 is mounted and the injector device 100 has been disabled. While in the disabled configuration, the actuation of the trigger 170 will not fire the injection assembly 140. The ram 141 is disposed in the retracted position and the latching lugs 145 of the ram 141 are placed on the resting device 152 of the inner housing body 151. The constant force spring 149 is pulled.

The indicator body 176 is held in a limited position against the deflection of the indicator spring 179. [ In particular, the ram 141 inhibits the flexible arms 157 of the inner housing 150 from bending inwardly, allowing the stop 158 (Fig. 18) to maintain the indicator body 176 . Moreover, the shoulder 147 of the ram 141 may engage the track follower 178 to inhibit forward movement of the indicator body 176 (FIG. 12). The shoulder 147 may also be pressed against the track follower 178 when mounting the infusion device 140 to reset the indicator body 176 in a rearward position (see, e.g., FIGS. 5 and 7).

While the injector device 100 is in an inoperative state, the inner housing body 151 is axially fixed relative to the outer housing assembly 131 (see FIG. 12). The fixed shoulder 164 of the inner housing body 151 abuts one end of the support member 138 of the middle outer housing 137 so that the inner shoulder 164 of the inner housing 150 Thereby suppressing forward axial movement. The latching hook of the interlocking arm 155 (i.e., the rearward facing shoulder 159) engages the shoulder 139 at the end of the opposite end of the support member 138, Thereby suppressing the forward axial movement of the housing 132 (Fig. 12). The trigger spring 174 also deflects the rear outer housing 132 to an extended position relative to the inner housing 150 (FIG. 12). For example, one end of the spring 179 is seated on the ceiling structure 154 of the inner housing 150 and the opposite end of the spring 179 is pressed against the inside of the button 171 (Fig. 12 Reference).

As shown in FIG. 12, the injection assembly 140 does not operate even when the trigger button 171 is pressed while the rear outer housing 132 is disposed at the extended position. Depressing the trigger button 171 into the rear outer housing 132 causes the ramp structure 173 to move forwardly toward the ledge structure 152 of the inner housing 150 within the button 171. [ However, even when the button 171 is fully depressed, the ramp structure 173 does not reach the latching lugs 145 of the ram latching arm 144. Thus, the button ramp structure 173 can not unlatch the latch arm 144 from the ledge structure 152, thereby actuating the injection assembly 140.

Figures 13-19 illustrate how the injector apparatus 100 is switched from an inoperative configuration to an operable configuration. The front assembly 110 is attached to the rear assembly 130 so that the band of the mutual locking body 161 is visible between the carrier support 114 and the middle outer housing 137. [ The first alignment indicator 165 of the front assembly 110 aligns with the second alignment indicator 166 of the rear assembly 130. For example, the front assembly 110 is threaded into the rear assembly 130 until the first and second alignment indicators 165, 166 point toward each other to indicate rotational alignment of the front and rear assemblies 110, Can be assembled. 14, when the front and rear assemblies 110, 130 are rotationally aligned, the rear assembly 130 can be moved axially forwardly toward the front assembly 110 to form an intermediate outer housing 137 ) (See Figs. 13 and 14).

15 and 16 are axial cross-sectional views of the injector device 100 showing the transition from inoperative configuration to operational configuration. The axial spacing between the housing structure 150 of the inner housing 150 and the rear end 102 of the rear outer housing 132 is such that even when the trigger button 171 is pressed, It is sufficient to maintain the separation of the ramp structure 173 of the trigger button 171 from the latch lugs 145 of the injector device 100 (for example, see FIG. 15) The trigger button 171 does not actuate the injection assembly 140.

Since the latching arm 155 is unlocked (i.e., bent inward), the rear outer housing 132 is biased against the bias of the trigger spring 174 relative to the inner housing 150 and the front assembly 110 And can be moved to the retracted position. The rear outer housing 132 moves to cover the mutual locking body 161 so that the mutual locking body 161 is no longer visible to the user. Sliding the rear outer housing 132 to the retracted position causes the trigger button 171 to become closer to the redering structure 152 and the ram latching lugs 145, as shown in FIG. The ramp structure 173 is now engaged with the latching lugs 145 of the ram latch arm 144 by pushing the trigger button 171 of the operative injector device 100.

FIGS. 17-19 illustrate how mutual locking device 160 enables switching of injector device 100 from an inoperative configuration to an operational configuration. As shown in FIG. 17, the front assembly 110 includes one or more rearward extending tabs 167 (e. G., Disposed behind the carrier support 114). 19, the rearwardly extending tabs 167 form a ramp-shaped or otherwise contoured surface 168 which is in contact with the surface of the interlocking arm 155 of the inner housing 150 And has a shape that interacts with a ramp or otherwise shaped surface 169 at the free end. For example, a tab 167 may ride over a snap-over surface 169a of the contoured surface 169. In certain embodiments, the tab 167 forms an audible sound (e.g., a click sound) when the tab 167 rides over the snap-over surface 169a.

When the front assembly 110 is threadedly coupled to the rear assembly 130, the tabs 167 extending rearward of the front assembly 110 engage the interlocking arms 155 with a radius < RTI ID = 0.0 > Engage the free end of the interlocking arm 155 so as to deflect inward in the direction of the arrow. The inward bending of the interlocking arm 155 moves the latching hook of the interlocking arm 155 (and thus the rearwardly facing shoulder 159) away from the support member 138 of the inner housing 150 15). The rear outer housing assembly 132 can be moved forward relative to the interlocking body 161 while the interlocking arms 155 are held in an inwardly bent position (see FIG. 16).

In some embodiments, the interlocking assembly 160 includes a latch spring 189 (FIG. 3) that deflects the interlocking arm 155 radially outwardly from the locked position. In some embodiments, the latch spring 189 provides support for the interlocking arm 155 to prevent breakage of the repeated post-use arm 155. In such embodiments, the interlocking arms 155 are primarily deflected toward the locked position by the material elasticity and resilience of the interlocking arms 155 themselves. In other embodiments, the latch spring 189 serves to retain the interlocking arm 155 in the locked position.

FIGS. 16 and 20-22 illustrate the operation of the injection assembly 140 of the injector apparatus 100. FIG. As shown in FIG. 16, the injector device 100 is arranged in an operable configuration to initiate injection. The carrier spring 116 biases the syringe carrier 111 backward and the needle 185 is disposed within the depth adjuster 117. The syringe plunger 182 extends rearward toward the ram 141 disposed in the retracted position. In certain embodiments, the abutment surface 142 of the ram 141 is axially spaced from the syringe plunger 182. In other embodiments, the ram 141 contacts the syringe plunger 182. The trigger button 171 is within each of the latching lugs 145 of the ram latch arms 144.

The ramp structure 173 is pushed in the direction F in which the ramp structure 173 is bent away from the rest structure 152 of the inner housing 150 by pressing the trigger button 171 in the pressing direction D, And pushes the latching lug 145 of the arm 144. In certain embodiments, the re- sidemember 152 is configured to move the latching lugs 145 in the side bending direction F until the latching lugs 145 clear the re- siding structure 152, (See Fig. 20) which causes the ram 141 to move backward against the deflection of the cam 149. The ram 141 is no longer held against the deflection of the constant load spring 149. As the latching lugs 145 expose the ledge structure 152,

As shown in Fig. 21, the constant load spring 149 pulls the ram 141 forward toward the deflection position when the ram 141 is no longer held in the retracted position. When the ram 141 is moved forward, the abutment surface 142 of the ram 141 engages the syringe plunger 182. However, the ram 141 does not immediately move the plunger 182 within the ampule 181. Rather, the carrier spring 116 begins to compress before the plunger 182 begins to move within the ampule 181 because the compression resistance of the carrier spring 116 is sufficiently low. When the carrier spring 116 is compressed, the syringe carrier 111 moves forward relative to the carrier support 114 until the hub 113 of the syringe carrier 111 engages the front wall of the carrier support 114 (For example, engaged with the first damper 192). The syringe carrier 111 carries the syringe 180 forward, thereby injecting the needle 185 into the injection site.

As shown in FIG. 22, the ram 141 presses the plunger 182 into the ampule 181 to dispense the medicament. The forward force of the ram 141 is sufficient to overcome the resistance of the plunger 182 when the syringe carrier 111 is fully drawn out (i.e., engaged with the front wall). Since the ram spring 149 is a constant load shifting ring, the medicament is dispensed from the injector 180 at a more consistent rate than using a coil spring. After the medication is dispensed, the ram spring 149 maintains a forward pressure on the syringe plunger 182. Thus, the syringe needle 185 remains extended from the forward end 101 of the injector device 100, even after the injector device 100 has been removed from the injection site.

Referring to Figures 16, 21, and 22, a rapid completion indicator 175 is automatically activated by the injection assembly 140. 16, the indicator body 176 is disposed in the rearward position against the deflection of the indicator spring 179 prior to actuation of the trigger button 171. As shown in FIG. When in the retracted position, the ram 141 suppresses the bending of the inner housing 150 toward the inside of the arm 157. Thus, the stop member 158 (FIG. 20) holds the indicator body 176 against the bias of the spring 179. In addition, the shoulder 147 of the ram 141 engages the track follower 178 of the indicator body 176 (Fig. 16). As shown in FIG. 21, the indicator body 176 is still held in the rearward position because the ram 141 still extends along a portion of the flexible arms 157.

22, the indicator body 176 is deflected relative to the stop member 158 to expose the flexible arms 157 when the ram 141 moves sufficiently forward within the inner housing 150, Thereby enabling inward movement of member 158. In the illustrated example, when the piston 183 is fully drawn out of the syringe ampule 181, the ram 141 exposes the flexible arm 157. In other embodiments, when the plunger 182 has been moved sufficiently forward to dispense a batch of medicament from the syringe 180 (e.g., even when the piston 183 is not "fully drawn out" The ram 141 causes the flexible arm 157 to be exposed.

The indicator spring 179 pushes the indicator body 176 forward relative to the inner housing 150. As the housing 176 slides forward, the track follower 178 slides within the longitudinal track 156 formed in the side wall of the inner housing body 151. The track follower 178 suppresses the rotation of the indicia member 176 when the indicator member 176 moves forward. Thus, the track follower 178 inhibits the indicator body 176 from aligning with the window 134 and moving away from the peripheral alignment (FIG. 1).

  As shown in Fig. 22, the indicator body 176 aligns radially with the window 134 when the medicament is dispensed. As shown in Figure 1, the inner housing body 151 is visible through the window 134 before the indicator body 176 aligns with the window 134. As shown in FIG. 22, the indicator body 176 is visible through the window 124 when dispensing is complete. In some embodiments, the indicator body 176 is a different color (e.g., red) than the inner housing body 151 (e.g., white). Thus, an abrupt color change in the window 134 indicates the completion of the injection process.

As noted above, the phrase "at completion" includes the time of completion, time immediately after completion, or time within a few milliseconds before or after completion (e.g., by tolerance within the injection device) Frame can be referred to. When multiple events occur "on completion", they can occur simultaneously, in another event immediately following an event, or within several milliseconds within each other. In some embodiments, when the track follower 178 engages the shoulder 177 of the inner housing 150 when the indicator body 176 reaches a forward position (see FIG. 22), the track follower 178 engages the audible Noise (e.g., "click"). Thus, in some implementations, the quick completion indicator 175 generates audible noise to send a completion signal of the dispensing step.

In some embodiments, the indicator spring 179 is sufficiently strong to appear at the same time as the indicator body 176 fills the window 134. For example, the indicator spring 179 may move the indicator body 176 significantly forward so that the user can not follow the movement of the front end of the indicator body 176 along the window 134. Movement of the indicator body 176 relative to the window 134 is not subject to movement of the plunger 182 in the syringe ampoule 181 (i. E., Separated from movement of the plunger). For example, when the flexible arm 157 is exposed, the indicator body 176 moves forward by the indicator spring 179 without being affected by the position of the ram 141 in the inner housing body 151.

The injector device 100 is configured for use with a syringe containing an injectable fluid. One suitable exemplary fluid contained within the syringe is glatiramer acetate. Glutamer acetate (GA), also known as Copolymer-1, is shown to be effective in treating multiple sclerosis (MS) (Lampert, 1978). Daily subcutaneous infusion of glatiramer acetate (20 mg / infusion) resulted in the appearance of new lesions by recurrence rates, progression of the disorder, magnetic resonance imaging (MRI) (Johnson, 1995) and appearance of "black holes" (Filippi, 2001).

COPAXONE® is a trade name for a formulation containing glatiramer acetate as an active ingredient. Glatiramer Acetate is approved to reduce the frequency of recurrences in relapsing-remitting multiple sclerosis (RRMS). Glatiramer Acetate contains four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine, which have an average molar fraction of COPAXONE® of 0.141, 0.427, 0.095 and 0.338, It consists of acetate salts of synthetic polypeptides. In COPAXONE®, the average molecular weight of glatiramer acetate is 4,700 to 11,000 daltons. Chemically, glatiramer acetate is a designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structure is as follows:

(Glu, Ala, Lys, Tyr ) x ACH 3 COOH

(C 5 H 9 NO 4 AC 3 H 7 NO 2 AC 6 H 14 N 2 O 2 AC 9 H 11 NO 3 ) P APC 2 H 4 O 2

CAS-147245-92-9.

Recurrent relief The recommended dosing schedule for COPAXONE® for multiple sclerosis is subcutaneously injected at 20 mg / d (Physician's Desk Handbook). Additional information on dosing schedules may also be found in U.S. Patent Nos. 3,849,550; 5,800,808; 5,859, 964, 5,981, 589; 6,048, 898; 6,054, 430; 6,214, 791; 6,342, 476; And 6,362,161, the disclosures of which are hereby incorporated by reference herein.

Although the mechanism of its action is not fully described, it is believed that the GA is bound to a major histocompatibility complex (MHC) molecule and displayed as an antigen in the groove of this molecule. Alternatively, GA is thought to be enveloped by antigen presenting cells (APCs) and fragments are then provided. Either way, the provision of GA results in the generation of GA-specific T cells. Through still unclear mechanisms, GA-specific T-cells are mostly biased T helper 2 (Th2). Th2 cells produce Th2 cytokines that inhibit the production of cytokines by Th1 cells or macrophages, and are intended to be anti-inflammatory agents. Unlike interferon-beta, which has a distinctly strong action in the blood-brain barrier (BBB) that reduces the migration of inflammatory cells to the CNS, GA has a negligible effect on BBB, suggesting that GA-specific Th2 lymphocytes (Young et al., 2002).

Some aspects of the injector device include (a) a first housing assembly configured to hold a syringe; (b) a second housing assembly including an outer housing and an inner housing; (c) a locking member firmly holding the outer housing in an extended position; And (d) an interlocking assembly configured to rotatably attach the first housing assembly to the second housing assembly at a particular rotational position. The inner housing is configured to be axially fixed relative to the first housing assembly. The outer housing is configured to move axially relative to the first housing assembly between the extended and retracted positions. The second housing assembly includes an injection assembly configured to actuate the syringe to inject the medicament from the syringe. The second housing assembly includes a trigger member configured to launch the injection assembly only when the outer housing is in the retracted position. The second housing assembly includes a biasing member that biases the outer housing to an extended position. The interlocking assembly is also configured to release the locking member when the first and second housing assemblies are in a particular rotational position. The outer housing is actuated relative to the first housing assembly in the depressed position against deflection of the biasing member when the locking member is released.

In certain example implementations, the first housing assembly includes a first alignment indicator, and the outer housing of the second housing assembly includes a second alignment indicator, wherein the first and second alignment indicators are positioned between the first and second alignment indicators, 2 When the housing assemblies are oriented to a particular rotational position.

In certain example implementations, the interlocking assembly includes an interlocking band visible between the first housing assembly and the second housing assembly when the outer housing is disposed in an extended position, wherein when the outer housing is in the retracted position Interlocking bands are not visible.

In certain example implementations, the locking member includes a flexible latching hook disposed on the inner housing, the latching hook configured to engage a shoulder disposed on the interior of the outer housing, wherein the interlocking assembly includes a first And a tab that bends the latching hook away from the shoulder when the second housing assemblies are directed to a particular rotational position.

In certain example implementations, the trigger member is mounted to the outer housing and includes a button configured to move between a ready position and a pushed position. The button is spaced far enough away from the injection assembly when the outer housing is located in the extended position, thereby inhibiting the button from firing the injection assembly even when in the depressed position. By moving the outer housing to the retracted position, the button is moved sufficiently close to the injection assembly to allow firing of the injection assembly when the button is moved to the depressed position.

In certain example implementations, the injection assembly includes a ram and a spring biasing the ram toward the syringe. The ram includes a flexible latch arm that engages a shoulder formed by the inner housing to hold the ram against deflection of the spring. Moving the buttons sufficiently close to the injection assembly involves moving the button within the range of the flexible latch such that movement of the button to the depressed position biases the flexible latch away from the shoulder to release the ram.

In certain example implementations, the biasing member deflects the outer housing toward the extended position by deflecting the button away from the inner housing and toward the ready position.

In certain example implementations, the outer housing moves relative to the first housing assembly when the first housing assembly is abutted against the injection side and the user grasps the outer housing and pushes the outer housing toward the injection site.

In certain example implementations, the syringe contains a formulation comprising glatiramer acetate. In one exemplary implementation, the formulation comprises 20 mg glatiramer acetate per ml of formulation. In one exemplary implementation, the formulation comprises 40 mg of glatiramer acetate per ml of formulation.

In certain example implementations, the syringe includes a needle configured to extend from a first housing assembly during a dispensing step, wherein the first housing assembly includes a depth adjuster that changes the length of the needle extending from the first housing assembly.

In certain example implementations, the depth adjuster is actuated between separate stop positions, each separate stop position corresponding to a different needle depth, by moving the depth adjuster to one of the different stop positions, Select the needle depth.

In certain example implementations, the needle cover remover is assembled on the depth adjuster. The needle cover remover is configured to couple with the depth adjuster such that the depth adjuster is fixed in the axial and rotational directions during any movement of the needle cover remover.

In certain example implementations, a number is displayed on the depth adjuster to indicate the needle depth, wherein the displayed number is at least 4 mm in size.

In certain example implementations, the second housing assembly includes a compressible gripping surface that extends over a portion of the exterior of the second housing assembly.

In certain example implementations, each of the first and second housing assemblies includes a threaded region that secures to the other threaded region for coupling the first and second housing assemblies.

In certain example implementations, each of the threaded regions includes a thread extending approximately within the inner periphery of the respective housing assembly.

In certain example implementations, the threads of each threaded region extend approximately half of the inner circumference of each housing assembly.

In certain example implementations, the first housing assembly includes a first tab and the second housing assembly defines a snap-over surface, wherein when the first and second housing assemblies are threaded together, Over surface, wherein the first tab creates an audible sound when the first tab is raised over the snap-over surface.

In certain example implementations, a rapid completion indicator member is disposed within the interior of the outer housing. The quick completion indicator member is configured to move relative to the outer housing between the first and second positions. Wherein the rapid completion indicator member is visible through the window when in the first position but not through the window formed in the outer housing and in the second position wherein movement from the first position to the second position of the quick completion indicator member is effected by the dispensing It is activated upon completion of the step.

In certain example implementations, the color change is visible through the window as the fast completion indicator member moves from the first position to the second position.

In certain example implementations, the injector device generates an audible tone upon completion of the dispensing step.

In certain example implementations, the rapid completion indicator member is deflected toward the second right hand by a biasing member, wherein the injection assembly comprises at least one stationary member that holds the quick completion indicator member against deflection of the biasing member, The stop member automatically releases the indicator member upon completion of the dispensing step.

The above specification, examples and data provide a complete description of the manufacture and use of the present invention. Numerous embodiments of the invention can be made without departing from the spirit and scope of the invention, which in the claims hereafter falls within the scope of the appended claims.

references

1. Lampert, autoimmune and virus-induced dehydration diseases, review, Am. J. Path. , 1978, 91: 176-208.

2. Johnson, et al., Copolymer 1 Reduces recurrence and improves disability in relapsing remitting multiple sclerosis: a result of Phase III manifolds, double-blind placebo-controlled trial. Copolymer 1 Multiple Sclerosis Study Group, Neurol. , ≪ / RTI > 1995, 45: 1268.

3. Filippi et al., Glatiramer Acetate Reduces the Rate of MS Transition to Black Hole, Neurol . , ≪ / RTI > 2001, 57: 731-733.

4. The table in the doctor's Manual for "COPAXONE®", Thompson Reuters - doctors desk Handbook Inc., Montvale, NJ, 2008, 3110-3113 for.

5. Young (2002) "Differential mechanisms of the action of interferon-β and glatiramer acetate in MS" Neurology , 59: 1-7.

Claims (24)

As an injector device,
(a) a first housing assembly configured to hold a syringe;
(b) a second housing assembly comprising an outer housing and an inner housing, the inner housing configured to be axially fixed relative to the first housing assembly, the outer housing having a first The second housing assembly configured to move axially with respect to the housing assembly, the second housing assembly including an injection assembly configured to actuate the syringe to inject a medicament from the syringe, the second housing assembly having an outer housing in a retracted position A second housing assembly including a biasing member configured to deflect the outer housing to an extended position;
(c) a locking member firmly holding the outer housing in the extended position; And
(d) an interlocking assembly configured to rotatably attach a first housing assembly to a second housing assembly at a particular rotational position, the interlocking assembly further comprising a locking member, when the first and second housing assemblies are in a particular rotational position, Wherein the outer housing is movable relative to the first housing assembly to a retracted position against deflection of the biasing member when the locking member is released,
Injector device. The method according to claim 1,
Wherein the first housing assembly includes a first alignment indicator and the outer housing of the second housing assembly includes a second alignment indicator wherein the first and second alignment indicators are configured to allow the first and second housing assemblies to rotate When aligned to a position,
Injector device. The method according to claim 1,
The interlocking assembly includes an interlocking band that is visible between the first housing assembly and the second housing assembly when the outer housing is in its extended position, wherein the interlocking band is invisible when the outer housing is in the retracted position ,
Injector device. The method according to claim 1,
Wherein the locking member comprises a flexible latching hook disposed in the inner housing, the latching hook configured to engage a shoulder disposed within the outer housing, the interlocking assembly having a first and a second housing assemblies, And a tab for bending the latching hook away from the shoulder when oriented in the rotational position.
Injector device. 5. The method of claim 4,
Wherein the trigger member is mounted to the outer housing and is configured to be moved between a ready position and a pushed position, wherein when the outer housing is disposed in the extended position, the button is spaced far enough away from the injection assembly, And moving the outer housing to a retracted position to move the button sufficiently close to the injection assembly to enable firing of the injection assembly when the button is moved to the depressed position doing,
Injector device. 6. The method of claim 5,
The injection assembly includes a spring biasing the ram and ram toward the syringe, the ram including a flexible latch arm engaging a shoulder formed by the inner housing to hold the ram against deflection of the spring, Moving the button sufficiently close to the injection assembly may include moving the button into the range of the flexible latch such that movement of the button to the depressed position pushes the flexible latch away from the shoulder to release the ram,
Injector device. The method according to claim 6,
The biasing member deflecting the outer housing toward the extended position by deflecting the button away from the inner housing and toward the ready position,
Injector device. 5. The method of claim 4,
Wherein the outer housing moves relative to the first housing assembly when the first housing assembly is pressed against the injection side and the user grasps the outer housing and pushes the outer housing toward the injection site.
Injector device. The method according to claim 1,
Wherein the syringe comprises a formulation comprising glatiramer acetate,
Injector device. 10. The method of claim 9,
The formulation is a 1 milliliter (milliliter) formulation containing 20 mg of glatiramer acetate,
Injector device. 10. The method of claim 9,
The formulation is a 1 mL formulation containing 40 mg of glatiramer acetate,
Injector device. The method according to claim 1,
Wherein the syringe includes a needle configured to extend from a first housing assembly during a dispensing step and wherein the first housing assembly includes a depth adjuster that changes the length of the needle extending from the first housing assembly,
Injector device. 13. The method of claim 12,
Wherein the depth adjuster is actuated between separate stop positions, each separate stop position shifting the depth adjuster to one of the different stop positions corresponding to different needle depths to select a corresponding needle depth,
Injector device. 13. The method of claim 12,
Wherein the needle cap liner is configured to be coupled to the first housing assembly such that the depth adjuster is axially and rotationally movable during any movement of the needle lid remover, To remain fixed,
Injector device. 13. The method of claim 12,
Numbers are displayed in the depth adjuster to indicate the needle depth, the displayed numbers being at least 4 mm in size,
Injector device. The method according to claim 1,
Wherein the second housing assembly includes a compressible gripping surface extending over a portion of the exterior of the second housing assembly.
Injector device. The method according to claim 1,
Wherein each of the first and second housing assemblies includes a threaded region and the threaded region is secured to another threaded region to couple the first and second housing assemblies,
Injector device. 18. The method of claim 17,
Wherein each of the threaded regions includes a thread extending approximately within an inner circumference of the respective housing assembly.
Injector device. 19. The method of claim 18,
Wherein the threads of each of the threaded regions extend approximately half the inner circumference of the respective housing assembly,
Injector device. 19. The method of claim 18,
The first housing assembly includes a first tab and the second housing assembly forms a snap-over surface, and the first tab is configured such that the first and second housing assemblies are threaded together Over surface and the first tab generates an audible sound as the first tab rides over the snap-over surface,
Injector device. The method according to claim 1,
Wherein the rapid completion indicator member is configured to move relative to the outer housing between a first position and a second position, the quick completion indicator member is configured to move between a first position and a second position, And wherein movement of the quick completion indicator member from the first position to the second position is visible upon completion of the dispensing step, felled,
Injector device. 22. The method of claim 21,
A color change is visible through the window as the rapid completion indicator member moves from the first position to the second position,
Injector device. 22. The method of claim 21,
Wherein the injector device generates an audible sound upon completion of the dispensing step,
Injector device. 22. The method of claim 21,
Wherein the rapid completion indicator member is deflected toward the second position by a biasing member and the injector assembly includes at least one stop member for holding the quick completion indicator against deflection of the biasing member, And automatically releasing the indicator member upon completion of the dispensing step,
Injector device.
KR1020157027577A 2013-03-08 2014-03-07 Re-useable injector device for syringe KR101780191B1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US13/790,487 2013-03-08
US13/790,487 US8652100B1 (en) 2013-03-08 2013-03-08 Re-useable injector device for syringe
CA2808875 2013-03-08
CA2808875A CA2808875A1 (en) 2013-03-08 2013-03-08 Re-useable injector device for syringe
EP13158407.0A EP2774639B1 (en) 2013-03-08 2013-03-08 Re-useable injector device for syringe
EP13158407.0 2013-03-08
PCT/IB2014/000860 WO2014140820A2 (en) 2013-03-08 2014-03-07 Re-useable injector device for syringe

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KR20150126657A true KR20150126657A (en) 2015-11-12
KR101780191B1 KR101780191B1 (en) 2017-09-21

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KR (1) KR101780191B1 (en)
AU (2) AU2014229581B2 (en)
BR (1) BR112015021548A2 (en)
CL (1) CL2015002524A1 (en)
EA (1) EA029122B1 (en)
IL (1) IL240559B (en)
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GB2460398A (en) * 2008-05-20 2009-12-02 Owen Mumford Ltd Auto-injector having a magnetic injection indicator and a needle sheath retainer
GB2463034B (en) * 2008-08-28 2012-11-07 Owen Mumford Ltd Autoinjection devices
PT2275086E (en) * 2009-07-15 2012-05-18 Teva Pharma Reduced volume formulation of glatiramer acetate and methods of administration
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GB2474308A (en) * 2009-10-12 2011-04-13 Pa Knowledge Ltd Syringe auto-injector system suitable for variable doses
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WO2012072552A1 (en) * 2010-11-29 2012-06-07 Sanofi-Aventis Deutschland Gmbh Medicated module for use with auto-injector delivery device
CA3021845C (en) * 2011-04-20 2022-03-29 Amgen Inc. Autoinjector apparatus

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AU2014229581A1 (en) 2015-09-17
JP6073507B2 (en) 2017-02-01
MX2015011451A (en) 2016-06-10
EA201591666A1 (en) 2016-01-29
KR101780191B1 (en) 2017-09-21
EA029122B1 (en) 2018-02-28
PE20151576A1 (en) 2015-11-19
ZA201506670B (en) 2016-12-21
AU2014229581B2 (en) 2016-12-22
BR112015021548A2 (en) 2017-07-18
AU2017201949A1 (en) 2017-04-13
JP2016513485A (en) 2016-05-16
NZ630376A (en) 2016-09-30
CL2015002524A1 (en) 2016-02-19
IL240559B (en) 2019-06-30
IL240559A0 (en) 2015-10-29

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