Automatic injection device with a dampening element

An automatic injection device including a generally cylindrical syringe body having an opening, an outlet and an inner cylindrical surface adapted to contain an injectable liquid to be injected at an injection site via the outlet; a piston disposed in the cylindrical syringe body; a driving assembly, including an elongate plunger element having a forward end adapted to be axially inserted into the generally cylindrical syringe body and an at least partial forward sealing element mounted onto the elongate plunger element adjacent the forward end for creating an at least temporary slidable seal between the elongate plunger element and the inner cylindrical surface, whereby axial insertion of the elongate plunger element and the forward sealing element into the generally cylindrical syringe body creates friction between the forward sealing element and the inner cylindrical surface and also creates an at least temporary air spring between the forward sealing element and the piston, wherein the friction and the air spring dampen motion of the elongate plunger element.

REFERENCE TO RELATED APPLICATIONS

Reference is hereby made to PCT Patent application PCT/IL2016/050929, filed Aug. 25, 2016 and entitled “REUSABLE AUTOMATICE INJECTION DEVICE”, the disclosure of which is incorporated by reference herein in its entirety.

Reference is hereby made to U.S. Provisional Patent application Ser. No. 62/641,985, filed Mar. 12, 2018 and entitled “Automatic Injection Device With a Dampening Element”, the disclosure of which is hereby incorporated by reference and priority of which is hereby claimed pursuant to 37 CFR 1.78(a) (4) and (5)(i).

FIELD OF THE INVENTION

The present invention generally relates to an auto injector, and more specifically to an auto injector adapted for parenteral administration of substances (e.g., a medication) to a living organism (human or animal).

BACKGROUND OF THE INVENTION

Many automatic injectors are known in the art. It is known that while using automatic injectors, there is a mechanical impact applied to a medicament container by a driving mechanism, this impact can damage the medicament container or cause spillage of the medicament contained therein. It is desired to provide a mechanism which prevents such damage to medicament container or spillage of medicament before activation of the automatic injector.

SUMMARY OF THE INVENTION

It is thus one object of the present invention to present a cost effective and safe auto-injector adapted for parenteral administration of substances to a patient, having a dampening mechanism incorporated therein.

The invention is further related to, but is not limited to a self-administration of patients with chronic diseases such as rheumatoid arthritis (RA), multiple sclerosis (MS), HIV, and growth hormone deficiency.

In accordance with an embodiment of the present invention, an automatic injection device including a generally cylindrical syringe body having an opening, an outlet and an inner cylindrical surface adapted to contain an injectable liquid to be injected at an injection site via the outlet; a piston disposed in the cylindrical syringe body; a driving assembly, including an elongate plunger element having a forward end adapted to be axially inserted into the generally cylindrical syringe body and an at least partial forward sealing element mounted onto the elongate plunger element adjacent the forward end for creating an at least temporary slidable seal between the elongate plunger element and the inner cylindrical surface, whereby axial insertion of the elongate plunger element and the forward sealing element into the generally cylindrical syringe body creates friction between the forward sealing element and the inner cylindrical surface and also creates an at least temporary air spring between the forward sealing element and the piston, wherein the friction and the air spring dampen motion of the elongate plunger element.

Preferably, the driving assembly, including a housing defining an axial travel path having an inner wall surface, the elongate plunger element extending along a longitudinal axis and having a rearward end arranged for axial travel along the axial travel path and defining a rearward sealing element seat and an at least partial rearward sealing element mounted onto the elongate plunger element at the rearward sealing element seat for creating an at least temporary slidable seal between the elongate plunger element and the inner wall surface.

Further preferably, the rearward sealing element seat having a rearward sealing element support which is generally perpendicular to the longitudinal axis and a forward sealing element support, facing the rearward sealing element but being angled with respect thereto and with respect to the longitudinal axis, thereby allowing the rearward sealing element to be axially tilted from an orientation perpendicular to the longitudinal axis upon rearward axial displacement of the plunger element causing at least partial disengagement of the rearward sealing element from the inner wall surface of the axial travel path.

Still further preferably, the forward sealing element is an O-ring. Yet further preferably, the rearward sealing element is an O-ring.

In accordance with an embodiment of the present invention, at least one forward sealing element seat is defined adjacent the forward end of the elongate plunger element. Preferably, the at least one forward sealing element seat includes a rearwardly-facing wall portion, a forwardly-facing wall portion facing the rearwardly-facing wall portion, a narrowed cylindrical axial portion extending therebetween and a forwardly-facing tapered wall portion formed adjacent the forwardly-facing wall portion. Further preferably, at least one protrusion is formed on the forwardly-facing wall portion and extends towards the forwardly-facing tapered wall portion. Still further preferably, the at least one rearwardly-facing wall portion has at least one slot formed therein.

Further in accordance with an embodiment of the present invention, upon forward axial displacement of the plunger element relative the syringe, the forward sealing element engages the forwardly-facing tapered wall portion, thereby providing for a relatively high level of damping of axial motion of the plunger element relative the syringe.

Preferably, the protrusion is configured to at least partially disable the air spring during forward axial displacement of the plunger element. Alternatively, the piston is displaced axially forwardly by the plunger element, without mechanical contact therebetween.

Further preferably, upon rearward axial displacement of the plunger element relative the syringe, the forward sealing element engages the rearwardly-facing wall portion, thereby providing for a relatively low level of damping of axial motion of the plunger element relative the syringe. Still further preferably, upon rearward axial displacement of the plunger element, air contained within the syringe is configured to be released via the at least one slot.

Preferably, the forward sealing element is displaceable axially along the narrowed cylindrical axial portion. Alternatively, the forward sealing element is an annular element, being fixedly attached to the plunger element and radially extends outwardly with respect to the circumference of the plunger element. Further alternatively, the forward sealing element is a rubber-edged blade set, being fixedly attached to the plunger element and radially extends outwardly with respect to the circumference of the plunger element. Still further alternatively, the plunger element includes a plunger body and a separate forward dampening portion, configured for mounting of the forward sealing element thereon, and wherein the forward sealing element is radially extends outwardly with respect to the circumference of the separate forward dampening portion.

In accordance with an embodiment of the present invention, an automatic injection device including: a generally cylindrical syringe body having an opening, an outlet and an inner cylindrical surface adapted to contain an injectable liquid to be injected at an injection site via the outlet; a piston disposed in the cylindrical syringe body; a driving assembly, including a housing defining an axial travel path having an inner wall surface, an elongate axial plunger element extending along a longitudinal axis and having a rearward end arranged for axial travel along the axial travel path and defining at least one rearward sealing element seat and an at least partial rearward sealing element mounted onto the elongate plunger element at the at least one rearward sealing element seat for creating an at least temporary slidable seal between the elongate plunger element and the inner wall surface, the rearward sealing element seat having a rearward sealing element support which is generally perpendicular to the longitudinal axis and a forward sealing element support, facing the rearward sealing element support but being angled with respect thereto and with respect to the longitudinal axis, thereby allowing the rearward sealing element to be axially tilted from an orientation perpendicular to the longitudinal axis upon rearward axial displacement of the plunger element causing at least partial disengagement of the rearward sealing element from the inner wall surface of the axial travel path.

Preferably, the elongate axial plunger element having a forward end adapted to be axially inserted into the generally cylindrical syringe body and an at least partial forward sealing element mounted onto the elongate axial plunger element adjacent the forward end for creating an at least temporary slidable seal between the elongate plunger element and the inner cylindrical surface. Further preferably, axial insertion of the elongate axial plunger element and the forward sealing element into the generally cylindrical syringe body creates friction between the forward sealing element and the inner cylindrical surface and also creates an at least temporary air spring between the forward sealing element and the piston, wherein the friction and the air spring dampen motion of the elongate axial plunger element. Still further preferably, the forward sealing element support has at least one slot formed therein.

In accordance with an embodiment of the present invention, the at least one rearward sealing element seat includes a cylindrical axial portion extending from the rearward sealing element support to the forward sealing element support and a tapered axial portion formed adjacent the rearward sealing element support. Preferably, engagement of the rearward sealing element with the forward sealing element support provides for a relatively low level of damping of axial motion of the plunger element relative the housing. Further preferably, upon forward axial displacement of the plunger element, the rearward sealing element is displaced to an orientation perpendicular to the longitudinal axis causing engagement of the rearward sealing element with the inner wall surface of the axial travel path and thus a relatively high level of damping of axial motion of the plunger element relative the housing. Still further preferably, upon forward axial displacement of the plunger element, the rearward sealing element engages the tapered axial portion. Yet further preferably, upon rearward axial displacement of the plunger element, air contained within the housing is configured to be released via the at least one slot.

In accordance with an embodiment of the present invention, upon forward axial displacement of the plunger element, a partial vacuum is created between the housing and the rearward sealing element, thus enhancing damping of forward axial motion of the plunger element relative the housing. Preferably, the rearward sealing element is displaceable axially along the cylindrical axial portion. Further preferably, the rearward sealing element is an O-ring.

In accordance with another embodiment of the present invention, a medicament module, including: a module housing at least partially surrounding a needle shield and arranged along a mutual longitudinal axis therewith; an RNS remover assembly, attached to the needle shield and configured to be detachable from the needle shield but not to be subsequently re-attachable thereto.

Preferably, the module housing has a forward end and a rearward end and at least one finger disposed between the forward end and the rearward end and wherein the finger has at least one side protrusion. Further preferably, the needle shield has at least one mounting arm formed with a recess, the needle shield has a forward circumferential rim. Still further preferably, the at least one mounting arm is also formed with at least one slot, arranged rearwardly of the recess. Yet further preferably, the recess is disposed at a forward end of the mounting arm, the recess has a forward tapered surface.

In accordance with an embodiment of the present invention, the RNS remover assembly has an outer portion and an inner portion, the inner portion is slidable relative the outer portion along the longitudinal axis. Preferably, the outer portion has at least one longitudinally extending arm, which extends to an edge surface, and wherein the at least one longitudinally extending arm is formed with a protrusion. Further preferably, the outer portion has at least one rearwardly extending arm, which extends to a rearwardmost edge surface, and wherein the at least one rearwardly extending arm is formed with an inwardly extending protrusion, having a rearwardly-facing angled edge and a forwardly-facing angled edge, both being angled with respect to the longitudinal axis.

Preferably, the needle shield has at least one mounting arm formed with a recess and at least one slot, arranged rearwardly of the recess, the needle shield also has a forward circumferential rim. Further preferably, the module housing has a forward end and a rearward end and at least one finger disposed between the forward end and the rearward end and wherein the finger has at least one side protrusion.

In accordance with an embodiment of the present invention, in a storage operative orientation, when the RNS remover assembly is attached to the needle shield, the forward end of the module housing abuts the rearwardmost edge surface of the outer portion of the RNS remover assembly.

Preferably, in the storage operative orientation, relative displacement between the module housing and the needle shield is not permitted due to engagement of the at least one side protrusion of the module housing with the at least one slot of the needle shield. Further preferably, the protrusion of the outer portion is inserted into the recess of the needle shield in the storage operative orientation. Still further preferably, the RNS remover assembly is configured to be detached from the needle shield when the RNS remover assembly being pulled forwardly relative to the needle shield. Yet further preferably, the protrusion of the outer portion is disengaged from the recess of the needle shield when the RNS remover assembly is being detached from the needle shield. Still further preferably, the RNS remover assembly is being detached from the needle shield due to slidable displacement of the rearwardly-facing angled edge of the protrusion of the outer portion relative to the tapered surface of the recess of the needle shield.

In accordance with an embodiment of the present invention, when the RNS remover assembly is being pushed forwardly with respect to the needle shield, re-attachment of the RNS remover assembly to the needle shield is prevented by engagement of the protrusion of the outer portion with the circumferential rim of the needle shield. Preferably, during re-attachment of the RNS remover assembly to the needle shield, the forward end of the module housing is spaced from the rearwardmost edge surface of the outer portion of the RNS remover assembly, thus allowing relative displacement between the needle shield and the module housing. Further preferably, during re-attachment of the RNS remover assembly to the needle shield, relative displacement between the module housing and the needle shield is allowed due to disengagement of the at least one side protrusion of the module housing from the at least one slot of the needle shield.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Reference is now made toFIG. 1A, which is a simplified pictorial illustration of an automatic injection device with a medicament module adapted to be inserted thereinto, along with a sectional view of the medicament module as taken along lines B-B inFIG. 1A, the automatic injection device and the medicament module being constructive and operative in accordance with an embodiment of the present invention. Reference is additionally made toFIG. 1B, which is a simplified exploded illustration of the automatic injection device ofFIG. 1A.

As seen inFIGS. 1A and 1B, an automatic injection device100comprises a main housing portion102, a cover portion104and an end portion105, both of which are preferably in fixed snap fit engagement with main housing portion102.

Cover portion104is preferably formed with a transparent window portion106, which is preferably in fixed snap fit engagement with cover portion104and with a user-engageable actuation button108which is pivotably mounted at one side thereof onto cover portion104.

Disposed within main housing portion102there is provided a driving assembly130, which includes a control element140, which operatively engages a multifunctional retaining element150, which, in turn operatively engages an improved plunger and damper assembly3160, which is described in detail hereinbelow.

A multifunctional engagement element170operatively engages the improved plunger and damper assembly3160and multifunctional retaining element150and is operatively engaged by either latches112or unitary latch element122.

A first compression spring180operatively engages multifunctional retaining element150and improved plunger and damper assembly3160for driving them forwardly along a longitudinal axis190in a direction indicated by an arrow192. A second compression spring194is arranged in coaxial relationship with first compression spring180and operatively engages multifunctional engagement element170for driving it forwardly along longitudinal axis190in a direction indicated by arrow192.

All components of the automatic injection device100are preferably identical to that shown inFIGS. 1A & 1Bof PCT Patent application PCT/IL2016/050929 and described therein, other than the improved plunger and damper assembly3160, which is different from the elongate damping driver element160described in the PCT/IL2016/050929. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

It is particularly seen inFIG. 1Athat the automatic injection device100is adapted to receive a medicament module200thereinto. All components of the medicament module200are identical to that shown inFIGS. 35A-35Dof PCT Patent application PCT/IL2016/050929 and described therein. In an alternative embodiment of the present invention, an improved medicament module is utilized in conjunction with the automatic injection device100, such as described in detail hereinbelow with reference toFIGS. 14-24B.

Preferably, the automatic injection device100is reusable and the medicament module200is disposable. Alternatively, both the automatic injection device100and the medicament module200are disposable. Further alternatively, both the automatic injection device100and the medicament module200are reusable.

It is seen inFIG. 1A, particularly in the sectional view of the medicament module200that needle shield240is located generally inside and coaxial with module housing1500, such that respective axes1510and1710are coaxial. It is also seen that in a “storage” operative orientation of the medicament module200, the needle shield240, is fixedly retained in the module housing1500against axial relative movement therebetween.

It is additionally seen that syringe242is fixedly retained against rearward axial motion along axis1710relative to needle shield240and module housing1500by engagement of protrusion1725of needle shield240with flange248of syringe242.

It is further seen that syringe242is fixedly retained against forward axial motion along axis1710relative to needle shield240and module housing1500by engagement of flange248of syringe242with a portion of the module housing1500.

It is also described inFIGS. 35A-35Dof PCT Patent application PCT/IL2016/050929 that needle shield240is retained against forward or rearward axial displacement relative to module housing1500along coaxial axes1510and1710.

It is also seen inFIG. 1Athat RNS remover210is located generally forwardly of the module housing1500and both inside and outside of needle shield240and coaxially therewith such that, respective axes1987,1510and1710are coaxial. It is further seen that protrusions1991of RNS remover210are seated in corresponding recesses1728of the needle shield240.

It is particularly noted that the syringe242defines an inner surface3162.

Reference is now made toFIG. 2, which is a simplified pictorial illustration of the improved plunger and damper assembly3160useful in various automatic injection devices, such as shown inFIGS. 1A& B. Reference is additionally made toFIG. 3, which is a simplified exploded view illustration of the improved plunger and damper assembly3160ofFIG. 2.

It is noted that the improved plunger and damper assembly3160is useful in various automatic injection devices, such as described in the following Published PCT Patent Applications, for example: WO2008/047372; WO2017/033193; WO2015/118550 or WO2014/174519.

As seen inFIGS. 2 & 3, the improved plunger and damper assembly3160includes a plunger and damper body3170, which is generally arranged along a longitudinal axis3172. The plunger and damper body3170is configured for receiving a rearward dampening element3174, such as an O-ring, for example and a forward dampening element3176, such as an O-ring for example.

Reference is now made toFIGS. 4A-4E, which are respectively a simplified pictorial, two simplified different side views and two orthogonal sectional illustrations of the plunger and damper body3170, forming part of the improved plunger and damper assembly3160ofFIG. 2, sections being taken along lines D-D inFIG. 4Cand lines E-E inFIG. 4B.

The plunger and damper body3170preferably has top to bottom and side to side general axial symmetry, and includes a generally planar base3180from which extends forwardly along axis3172a longitudinal rod3182having a generally rectangular cross section. The longitudinal rod3182terminates at a generally circular cylindrical portion3184having a forwardly facing contact surface3186, which lies in a plane perpendicular to axis3172.

Generally circular cylindrical portion3184is formed with respective top and bottom facing flat wall surfaces3188and3190.

Longitudinal rod3182is formed with respective top and bottom facing channels3192and3194, each having respective forward and rearward bulkhead surface3196and3198.

Longitudinal rod3182is formed with generally planar side-facing surfaces3200and3202, each terminating at a rearwardly-facing shoulder surface3204and each having a forward side protrusion3206. Each side protrusion3206preferably includes a tapered planar forward-facing surface3208, an apex3210and a tapered planar rearward-facing tapered surface3212extending from the apex3210. A generally half-circular section3214is formed on each of the planar side-facing surfaces3200and3202, adjacent the rearwardly facing shoulders3204. The half-circular sections3214define a forwardly-facing surface3216.

It is a particular feature of an embodiment of the present invention that an axial movement direction dependent forward damping control friction element seat3220is formed typically between cylindrical portion3184and the half circular sections3214and is configured for receiving the forward dampening element3176.

It is seen inFIGS. 4A-4Ethat axial movement direction dependent forward damping control friction element seat3220preferably includes a forwardly tapered section3222extending forwardly from the forwardly-facing surface3216, a narrowed cylindrical portion3224extending forwardly from the forwardly tapered section3222, terminating at a generally planar rearwardly facing surface3226, formed by the circular cylindrical portion3184.

Typically, at least one protrusion3230is formed on the forwardly-facing surface3216. Protrusion3230generally extends slightly towards forwardly tapered section3222.

Further, typically, at least one recess3232is formed on rearwardly facing surface3226. Recess3232generally extends slightly to the outer surface of circular cylindrical portion3184.

It is noted that, alternatively, series of axial movement direction dependent forward damping control friction element seats3220can be formed at the forward end of longitudinal rod3182.

It is further noted that, alternatively, the axial movement direction dependent forward damping control friction element seat3220can be formed without at least one of protrusion3230and recess3232.

Adjacent planar base3180, longitudinal rod3182includes a generally circular cylindrical portion3240from which extend a pair of rearward side protrusions3242. Each side protrusion3242preferably includes a planar forward-facing surface3244, a convex, radially outwardly facing surface3246and a planar rearward-facing surface3248.

Rearward of base3180there is formed an intermediate elongate portion3250, preferably having four radially extending stepped ribs3252, each separate by 90 degrees from its neighbors. Each of stepped ribs3252preferably includes a shoulder3254which defines a spring seat for a forward-facing end of spring180(FIG. 1B) and an elongate edge surface3256. Edge surfaces3256together serve to position spring180radially with respect to axis3172.

It is a particular feature of an embodiment of the present invention that rearwardly of intermediate elongate portion3250is a tilted axial movement direction dependent rearward damping control friction element seat3260, configured for receiving the rearward dampening element3174.

Rearward damping control friction element seat3260includes a rearwardly facing circumferential inclined surface3262, which lines in a plane disposed at an angle with respect to longitudinal axis3172, preferably having a pair of mutually oppositely radially outwardly directed slots3264. The inclined surface3262is typically slightly truncated to form a relatively small planar rearwardly facing surface3266adjacent the inclined surface3262.

Extending rearwardly from inclined surface3262is a generally circular cylindrical axial portion3270. Extending rearwardly from generally circular cylindrical axial portion3270is a generally circularly symmetric forwardly and outwardly tapered axial portion3272, which terminates at a forwardly facing planar annular surface3274, which lies in a plane generally perpendicular to the longitudinal axis3172. Planar annular surface3274faces the inclined surface3262and disposed at an angle with respect thereto.

It is appreciated that planar annular surface3274of the rearward damping control friction element seat3260and inclined surface3262of the rearward damping control friction element seat3260are defined on a single radially extending bulkhead, such as a bulkhead designated by reference numeral3280.

Rearwardly of the rearward damping control friction element seat3260there is preferably defined a rearward end portion3282having a rearwardly and inwardly tapered circumferential surface3284and a generally planar rearward facing surface3286.

Alternatively, there may be a series of rearward damping control friction element seat3260that are arranged axially one adjacent the other.

It is noted that in another embodiment of the present invention, the improved plunger and damper assembly3160can also include only one of either axial movement direction dependent forward damping control friction element seat3220adapted for mounting of forward dampening element3176thereon or axial movement direction dependent rearward damping control friction element seat3260adapted for mounting of rearward dampening element3174thereon.

Reference is now made toFIGS. 5A and 5B, which are respectively a simplified plan view illustration and a simplified sectional illustration taken along lines B-B inFIG. 5Aof a transition between respective relatively weak and relatively strong damping operative orientations of a portion of the improved plunger and damper assembly3160ofFIG. 2.

It is noted that inFIGS. 5A & 5Bonly the rearward dampening element3174is shown mounted onto axial movement direction dependent rearward damping control friction element seat3260of the improved plunger and damper assembly3160and the transition thereof is explained in detail hereinbelow.

As seen inFIGS. 5A and 5B, it is a particular feature of an embodiment of the present invention that when the improved plunger and damper assembly3160is in rearward motion, relative to main housing portion102as indicated by an arrow A and shown as stage I, the rearward dampening element3174located in the rearward damping control friction element seat3260is forced forwardly by frictional engagement with end cover105(FIG. 1B) into engagement with inclined surface3262and surrounds generally circular cylindrical axial portion3270and is generally at rest, thus providing a relatively low level of damping of axial motion of the improved plunger and damper assembly3160in rearward motion.

When the improved plunger and damper assembly3160is in forward motion, relative to main housing portion102as indicated by an arrow B and shown as stage II, rearward dampening element3174located in the rearward damping control friction element seat3260is forced rearwardly by frictional engagement with end cover105(FIG. 1B) into engagement with forwardly facing planar annular surface3274and surrounds tapered axial portion3272. Engagement of rearward dampening element3174with tapered axial portion3272forces rearward dampening element3174radially outwardly and thus increases its frictional engagement with end cover105, thus providing a relatively high level of damping of axial motion of the improved plunger and damper assembly3160in forward motion.

It is a particular feature of an embodiment of the present invention that the rearward dampening element3174is mounted onto the rearward damping control friction element seat3260of the plunger and damper body3170for creating an at least temporary slidable seal between the plunger and damper body3170and the inner facing surface931of the cylindrical portion906. The rearward damping control friction element seat3260has the forwardly facing planar annular surface3274which serves as a rearward sealing element support which is generally perpendicular to the longitudinal axis3172and the inclined surface3262, which serves as a forward sealing element support, facing the rearward sealing element but being angled with respect thereto and with respect to the longitudinal axis3172. Displacement of the rearward dampening element3174from its rearward operative orientation engaging the planar annular surface3274into its forward operative orientation engaging the inclined surface3262, allows the rearward dampening element3174to be axially tilted from an orientation perpendicular to the longitudinal axis3172upon rearward axial displacement of the plunger and damper body3170. The rearward dampening element3174in its forward operative orientation causing at least partial disengagement thereof from the inner facing surface931of cylindrical portion906.

It is an additional particular feature of an embodiment of the present invention that under rearward motion of the improved plunger and damper assembly3160, air which would otherwise be trapped between the rearward dampening element3174and the end cover105is released via slots3264. Were this air not to be released during rearward displacement of the improved plunger and damper assembly3160, it would resist required rearward motion of the improved plunger and damper assembly3160.

It is a further particular feature of an embodiment of the present invention that under forward motion of the improved plunger and damper assembly3160, a partial vacuum is created between the rearward dampening element3174and the end cover105due to sealing engagement between the rearward dampening element3174and the inner-facing surface931of the cylindrical portion906, which enhances damping of forward axial motion of the improved plunger and damper assembly3160relative to the main housing portion102.

Reference is now made toFIGS. 6A and 6B, which are respectively a simplified plan view illustration and a simplified sectional illustration taken along lines B-B inFIG. 6Aof a transition between respective relatively weak and relatively strong damping operative orientations of another portion of the improved plunger and damper assembly ofFIG. 2.

It is noted that inFIGS. 6A & 6Bonly the forward dampening element3176is shown mounted onto axial movement direction dependent forward damping control friction element seat3220of the improved plunger and damper assembly3160and the transition thereof is explained in detail hereinbelow.

As seen inFIGS. 6A & 6B, it is a particular feature of an embodiment of the present invention that when the improved plunger and damper assembly3160is in forward motion, relative to syringe242(FIG. 1A) as indicated by an arrow C and shown as stage I, forward dampening element3176located in the forward damping control friction element seat3220is forced rearwardly by frictional engagement with the inner surface3162of the syringe242(FIG. 1A) into engagement with forwardly facing surface3216as well as with protrusion3230and surrounds tapered axial portion3222. Engagement of forward dampening element3176with tapered axial portion3222forces forward dampening element3176radially outwardly and thus increases its frictional engagement with the inner surface3162of the syringe242, thus providing a relatively high level of damping of axial motion of the improved plunger and damper assembly3160in forward motion.

It is an additional embodiment of the present invention that the forward dampening element3176further enables dampening the movement of the improved plunger and damper assembly3160before engagement between the improved plunger and damper assembly3160and the piston243, thereby minimizing the risk of syringe breakage, even if the improved plunger and damper assembly3160has to travel a substantial distance up until engagement with the piston243, such as in case of injecting a low volume dosage of medication, such as under 1.5 ml, for example.

Engagement of forward dampening element3176with tapered axial portion3222forces forward dampening element3176radially outwardly, thus partially seals the volume between forward dampening element3176and the piston243, thereby causing pressure build-up therebetween and further enhances level of damping of axial motion of the improved plunger and damper assembly3160relative to syringe242in forward motion thereof.

It is noted that protrusion3230partially separates the forward dampening element3176from forwardly facing surface3216and thus provides for a small air passage, which in turn enables at least partial seal breakage between the forward dampening element3176and the piston243in order to allow air to escape in a rate which is slower than the rate of the pressure build-up. Allowing the air to escape enables engagement of the contact surface3186with piston243during forward displacement of the improved plunger and damper assembly3160. The release of the air-pressure may occur prior to starting of the medicament injection, during the medicament injection, at the end of medicament injection, or even not released at all, depending on the size of protrusion3230, or eliminating this protrusion at all.

It is further noted that in accordance with an alternative embodiment of the present invention, there is no such protrusion3230on the improved plunger and damper assembly3160, thus air remains trapped between the forward dampening element3176and the piston243, thus pressure continuously builds-up and forward displacement of the improved plunger and damper assembly3160urges forward displacement of the piston243through an air-spring formed therebetween, without any mechanical engagement between the contact surface3186and the piston243.

When the improved plunger and damper assembly3160is in rearward motion, relative to the syringe242as indicated by an arrow D and shown as stage II, the forward dampening element3176located in the forward damping control friction element seat3220is forced forwardly by frictional engagement with the inner surface3162of the syringe242(FIG. 1A) into engagement with rearwardly facing surface3226and surrounds narrowed cylindrical portion3224and is generally at rest, thus providing a relatively low level of damping of axial motion of the improved plunger and damper assembly3160in rearward motion.

It is an additional particular feature of an embodiment of the present invention that under rearward motion of the improved plunger and damper assembly3160, air which would otherwise be trapped between the forward dampening element3176and the inner volume of the syringe242is released via slots3232. Were this air not to be released, it would resist required forward motion of the syringe242relative to the improved plunger and damper assembly3160.

Reference is now made toFIGS. 7A-7C, which are respectively a simplified pictorial view and two orthogonal sectional illustrations of the automatic injection device100with the medicament module200ofFIGS. 1A & 1B, where the improved plunger and damper assembly3160ofFIG. 2is forming part of the automatic injection device100, sections being taken along perpendicular lines B-B and C-C inFIG. 7A, the automatic injection device100is shown in a charging operative orientation.

It is noted that all components of the automatic injection device100are preferably identical to that shown in PCT Patent application PCT/IL2016/050929 and described therein, other than the improved plunger and damper assembly3160, which is different from the elongate damping driver element160described in the PCT/IL2016/050929. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

It is also noted that the improved plunger and damper assembly3160is useful in various automatic injection devices, such as described in the following Published PCT Patent Applications, for example: WO2008/047372; WO2017/033193; WO2015/118550 or WO2014/174519.

It is seen inFIGS. 7B & 7Cthat in this charging operative orientation an axial force is applied on the improved plunger and damper assembly3160in a direction indicated by an arrow3300. The force is exerted on the improved plunger and damper assembly3160against the force of the first compression spring180, such that the first compression spring180is partially compressed in this operative orientation due to the fact that the first compression spring is supported against shoulder3254of the improved plunger and damper assembly3160.

As seen in enlargement A inFIG. 7C, a rearward portion of the improved plunger and damper assembly3160including a rearward portion of intermediate elongate portion3250and the rearward damping control friction element seat3260, is partially inserted in inner cylindrical volume930of generally circular cylindrical portion906of end cover105, such that rearward dampening element3174(FIG. 5A, stage I) is located adjacent the inclined surface3262of the improved plunger and damper assembly3160opposite bulkhead3280, inwardly of inner-facing surface931of generally circular cylindrical portion906of end cover105, thus exerting less frictional resistance to rearward displacement of the improved plunger and damper assembly3160, as seen in stage I inFIGS. 5A & 5B.

It is noted that in this particular embodiment of the present invention, the rearward dampening element3174is an O-ring, however it may alternatively be any other resilient element that provides for friction-fit interference between the improved plunger and damper assembly3160and the inner-facing surface931of the circular cylindrical portion906of end cover105.

It is a particular feature of an embodiment of the present invention that upon insertion of the rearward portion of the improved plunger and damper assembly3160into cylindrical volume930of generally circular cylindrical portion906of end cover105, rearward dampening element3174is forced forwardly by frictional engagement with inner-facing surface931of generally circular cylindrical portion906of end cover105into engagement with the inclined surface3262, thus positioning the rearward dampening element3174generally at rest. The positioning of the rearward dampening element3174adjacent the inclined surface3262(FIG. 5A, stage I) provides for a relatively low level of damping of axial motion of the improved plunger and damper assembly3160relative to the end cover105during rearward displacement of the improved plunger and damper assembly3160.

It is appreciated from a consideration of enlargement B inFIG. 7Bthat air compressed behind rearward dampening element3174in generally circular cylindrical portion906of end cover105is vented to the atmosphere via mutually radially outwardly directed slots3264formed on inclined surface3262(FIGS. 2-5B), thus effectively preventing air pressure resistance and resulting in that no additional force is required for rearward displacement of the improved plunger and damper assembly3160in the direction indicated by arrow3300. Were this air not to be released, it would resist required rearward motion of the improved plunger and damper assembly3160.

It is a further particular feature of an embodiment of the present invention that relatively low force is required for displacement of the improved plunger and damper assembly3160relative to end cover105due to the fact that rearward dampening element3174engages inclined surface3262, thus the profile of the rearward dampening element3174is minimized, causing lesser or no deformation of the rearward dampening element3174, thus lesser contact surface between the rearward dampening element3174and the inner-facing surface931of the generally circular cylindrical portion906of end cover105.

Due to the tilted geometry of the rearward damping control friction element seat3260, friction forces resisting to charging of the auto-injection device100are minimized in comparison to a planar geometry of damping control friction element seat where the rearward dampening element3174engages a planar surface during rearward displacement of the plunger and damper assembly. Therefore, in accordance with an embodiment of the present invention, the user can apply a relatively low force on the charging mechanism in order to charge the auto injection device100having the improved plunger and damper assembly3160.

Reference is now made toFIGS. 8A & 8B, which are respectively a simplified pictorial view and a sectional illustration of the automatic injection device100with the medicament module200ofFIGS. 1A & 1B, where the improved plunger and damper assembly3160ofFIG. 2is forming part of the automatic injection device100, section being taken along lines B-B inFIG. 8A, the automatic injection device100is shown in an activated operative orientation.

It is noted that all components of the automatic injection device100are preferably identical to that shown in PCT Patent application PCT/IL2016/050929 and described therein, other than the improved plunger and damper assembly3160, which is different from the elongate damping driver element160described in the PCT/IL2016/050929. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

It is also noted that the improved plunger and damper assembly3160is useful in various automatic injection devices, such as described in the following Published PCT Patent Applications, for example: WO2008/047372; WO2017/033193; WO2015/118550 or WO2014/174519.

It is seen inFIGS. 8B & 8Cthat in this activated operative orientation an axial force is applied onto the improved plunger and damper assembly3160by first compression spring180in a direction indicated by an arrow3310.

It is seen inFIG. 8Bthat once the auto injection device100is activated, the plunger and damper assembly3160is slightly axially displaced forwardly along axis3172and the3286of the plunger and damper assembly3160is more forwardly displaced with respect to the rearward end of the cylindrical portion906as compared toFIG. 7C. The rearward dampening element3174is forced rearwardly towards the forwardly facing planar annular surface3274of the improved plunger and damper assembly3160and causing engagement thereof with the forwardly and outwardly tapered axial portion3272. (FIG. 5A, stage II). The rearward dampening element3174is inserted in inner cylindrical volume930of generally circular cylindrical portion906of end cover105, following forward displacement of the improved plunger and damper assembly3160relative to main housing portion102and cover portion104.

It is appreciated from a consideration of enlargement A inFIG. 8Bthat engagement of rearward dampening element3174with the forwardly and outwardly tapered axial portion3272causes increased friction during forward displacement of the improved plunger and damper assembly3160thus dampening the forward displacement thereof as seen in stage II inFIGS. 5A & 5B. Upon engagement of rearward dampening element3174with the forwardly and outwardly tapered axial portion3272, the profile of the rearward dampening element3174is maximized, causing more deformation of the rearward dampening element3174, thus larger contact surface between the rearward dampening element3174and the inner-facing surface931of the generally circular cylindrical portion906of end cover105, which in turn provides for increased friction forces therebetween.

It is further appreciated that during forward motion of the improved plunger and damper assembly3160, a partial vacuum is created between rearward dampening element3174and the end cover105, which enhances damping of forward axial motion of the improved plunger and damper assembly3160relative to the main housing portion102.

It is a particular feature of an embodiment of the present invention that the enhanced friction and partial vacuum are configured for preventing damage to the syringe242and additional components of the automatic injection device100at the end of forward displacement of the improved plunger and damper assembly3160and additionally reduce noise during actuation of the automatic injection device100.

It is particularly seen inFIG. 8Bthat during forward displacement of the improved plunger and damper assembly3160, the rearward dampening element3174is forced rearwardly by frictional engagement with the inner-facing surface931of circular cylindrical portion906into engagement with tapered axial portion3272and planar annular surface3274. This engagement forces rearward dampening element3174radially outwardly and thus increases its frictional engagement with the inner-facing surface931of circular cylindrical portion906, thus providing a relatively high level of damping of forward axial motion of the improved plunger and damper assembly3160in forward direction, as indicated by arrow3310. It is noted that the angle of tapered axial portion3272can be adjusted to achieve different levels of increase in the friction/dampening of the forward displacement of improved plunger and damper assembly3160.

It is a particular feature of an embodiment of the present invention that the increased friction-fit interference between rearward dampening element3174and the inner-facing surface931of circular cylindrical portion906acts against the force of the first compression spring180, thus reduces forward advancement speed of the improved plunger and damper assembly3160relative to syringe242, thereby reducing the impact of the improved plunger and damper assembly3160on the piston243and thus minimizing the risk of breakage of syringe242and reduces the noise created by the impact.

It is seen inFIG. 8Bthat in this operative orientation the forwardly facing contact surface3186of the improved plunger and damper assembly3160does not yet engage piston243.

It is a particular feature of an embodiment of the present invention that damping force can be achieved in at least one of the following ways: friction engagement between dampening element3174and the inner-facing surface931of circular cylindrical portion906, vacuum, or a combination of both friction and vacuum.

Reference is now made toFIGS. 9A & 9B, which are respectively a simplified pictorial view and a sectional illustration of the automatic injection device100with the medicament module200ofFIGS. 1A & 1B, where the improved plunger and damper assembly3160ofFIG. 2is forming part of the automatic injection device100, section being taken along lines B-B inFIG. 9A, the automatic injection device100is shown in a start of injection operative orientation.

It is noted that all components of the automatic injection device100are preferably identical to that shown in PCT Patent application PCT/IL2016/050929 and described therein, other than the improved plunger and damper assembly3160, which is different from the elongate damping driver element160described in the PCT/IL2016/050929. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

It is also noted that the improved plunger and damper assembly3160is useful in various automatic injection devices, such as described in the following Published PCT Patent Applications, for example: WO2008/047372; WO2017/033193; WO2015/118550 or WO2014/174519.

It is seen specifically inFIG. 9Bthat there is no more friction-fit interference between the rearward dampening element3174and inner-facing surface931of the circular cylindrical portion906, thus the rearward dampening element3174is no longer operative to act against the force of spring180. It is appreciated that termination of damping force applied on the improved plunger and damper assembly3160by the rearward dampening element3174is dependent on the length of circular cylindrical portion906, such that if the circular cylindrical portion906is longer than the damping force is effective for a longer period of time and a longer longitudinal displacement extent of the improved plunger and damper assembly3160, thus the rearward dampening element3174could still be operative during a certain amount of time at the start of injection, when the forward end of the improved plunger and damper assembly3160is inserted into the syringe242.

Alternatively, the forward dampening element3176is effective for further dampening the improved plunger and damper assembly3160at the start of injection operative orientation, as is described in detail hereinbelow.

It is noted that medicament module200is mounted into automatic injection device100, as previously described with respect toFIG. 1A. The syringe242preferably having inner surface3162. Needle246is preferably mounted to the forward end of syringe242and flange248is formed at the rearward end of the syringe242. Piston243is positioned within syringe242and is configured to confine a medicament contained within syringe242.

It is appreciated that, alternatively, any type of medicament container can be inserted into the automatic injection device100in accordance with an embodiment of the present invention, such as a cartridge for example, which has a septum in its forward end, which is configured to be pierced by a needle.

It is seen inFIG. 9Bthat in this start of injection operative orientation an axial force is applied onto the improved plunger and damper assembly3160by first compression spring180in a direction indicated by an arrow3320, thus urging forward displacement of the improved plunger and damper assembly into syringe242, such that forward side protrusions3206of the improved plunger and damper assembly3160is now disposed at least partially within the syringe242.

It is a particular feature of an embodiment of the present invention that forward dampening element3176is mounted within forward damping control friction element seat3220of the improved plunger and damper assembly3160and the forward end of the improved plunger and damper assembly3160is inserted into syringe242, such that forward dampening element3176is disposed in a friction-fit interference with the inner surface3162of the syringe242.

It is a further particular feature of an embodiment of the present invention that the forward dampening element3176serves as a partial sealing element mounted onto the forward end of the plunger and damper body3170for creating an at least temporary slidable seal between the plunger and damper body3170and the inner cylindrical surface3162of the syringe242.

It is particularly seen inFIG. 9Bthat during forward displacement of the improved plunger and damper assembly3160, forward dampening element3176is urged into engagement with forwardly tapered section3222of forward damping control friction element seat3220by means of friction-fit engagement of the forward dampening element3176with the inner surface3162of the syringe242, as shown in stage I inFIG. 6A.

It is noted that in this particular embodiment of the present invention, the forward dampening element3176is an O-ring, however it may alternatively be any other resilient element that provides for friction-fit interference between the improved plunger and damper assembly3160and the inner surface3162of the syringe242.

It is seen inFIG. 9Bthat in this operative orientation the contact portion3186of the improved plunger and damper assembly3160is rearwardly spaced from piston243, such that there is no contact between the contact surface3186and the piston243. It is noted that the forward end of the improved plunger and damper assembly can initially be rearwardly spaced from flange248of the syringe242or it may alternatively be slightly inserted into the syringe242and forwardly spaced from flange248.

Engagement of forward dampening element3176with tapered axial portion3222forces forward dampening element3176radially outwardly, thus partially seals the volume between forward dampening element3176and the piston243, thereby causing pressure build-up therebetween and further enhances level of damping of axial motion of the improved plunger and damper assembly3160relative to syringe242in forward motion thereof.

It is noted that protrusion3230partially separates the forward dampening element3176from forwardly facing surface3216and thus provides for a small air passage, which in turn enables at least partial seal breakage between the forward dampening element3176and the piston243in order to allow air to escape in a rate which is slower than the rate of the pressure build-up. Allowing the air to escape enables engagement of the contact surface3186with piston243during forward displacement of the improved plunger and damper assembly3160. The release of the air-pressure may occur prior to starting of the medicament injection, during the medicament injection, at the end of medicament injection, or even not released at all, depending on the size of protrusion3230, or eliminating this protrusion at all.

It is further noted that in accordance with an alternative embodiment of the present invention, there is no such protrusion3230on the improved plunger and damper assembly3160, thus air remains trapped between the forward dampening element3176and the piston243, thus pressure continuously builds-up and forward displacement of the improved plunger and damper assembly3160urges forward displacement of the piston243through an air-spring formed therebetween, without any mechanical engagement between the contact surface3186and the piston243.

It is appreciated that, as seen inFIG. 9B, engagement of forward dampening element3176with the forwardly tapered section3222causes increased friction during forward displacement of the improved plunger and damper assembly3160thus dampening the forward displacement thereof as seen in stage I inFIGS. 6A & 6B. Upon engagement of forward dampening element3176with the forwardly tapered section3222, the profile of the forward dampening element3176is maximized, causing more deformation of the forward dampening element3176, thus larger contact surface between the forward dampening element3176and the inner surface3162of the syringe242, which in turn provides for increased friction forces therebetween, which acts against the force of the first compression spring180. Forward dampening element3176thus reduces the forward advancement speed of the improved plunger and damper assembly3160relative to the syringe242, thereby reducing the impact of the improved plunger and damper assembly3160on the piston243and thus minimizing the risk of breakage of syringe242and the noise created by the impact.

It is a particular feature of an embodiment of the present invention that axial forward insertion of the plunger and damper body3170with the forward dampening element3176into the syringe242creates friction between the forward dampening element3176and the inner surface3162of the syringe242and also creates an at least temporary air spring between the forward dampening element3176and the piston243, wherein the friction and the air spring dampen motion of the plunger and damper body3170.

It is noted that the angle of forwardly tapered section3222can be adjusted to achieve different levels of increase in the friction/dampening.

In accordance with this embodiment, air is trapped between the forward dampening element3176and the piston243, since the forward dampening element3176is disposed in a sealing relationship with the inner surface3162of the syringe242. It is a particular feature of this embodiment of the present invention that upon forward displacement of the improved plunger and damper assembly3160under the force of spring180, the pressure between the forward dampening element3176and the piston243builds up, thus causing advancement of piston243relative to syringe242without any mechanical contact between the contact surface3186of the improved plunger and damper assembly3160and the piston243. It is noted that in accordance with an embodiment of the present invention, the injection of medicament contained within syringe242may begin before engagement of the improved plunger and damper assembly3160and the piston243.

Reference is now made toFIGS. 10A-10C, which are respectively a simplified pictorial view and two orthogonal sectional illustrations of the automatic injection device100with the medicament module200ofFIGS. 1A & 1B, where the improved plunger and damper assembly3160ofFIG. 2is forming part of the automatic injection device100, sections being taken along lines B-B and C-C inFIG. 10A, the automatic injection device100is shown in a removal from the injection site operative orientation.

It is noted that all components of the automatic injection device100are preferably identical to that shown in PCT Patent application PCT/IL2016/050929 and described therein, other than the improved plunger and damper assembly3160, which is different from the elongate damping driver element160described in the PCT/IL2016/050929. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

It is also noted that the improved plunger and damper assembly3160is useful in various automatic injection devices, such as described in the following Published PCT Patent Applications, for example: WO2008/047372; WO2017/033193; WO2015/118550 or WO2014/174519.

It is seen inFIGS. 10A &10B that the entire amount of medicament is ejected from the syringe242and the piston243is disposed at the forwardmost end of the syringe242. The medicament module200is in the process of removal from the automatic injection device100in this operative orientation, thus the medicament module200, including the syringe242, are displaced forwardly with respect to the improved plunger and damper assembly3160, and as a result the improved plunger and damper assembly3160becomes more rearwardly spaced from the piston243, as indicated by an arrow3330.

It is a particular feature of an embodiment of the present invention that forward dampening element3176is mounted within forward damping control friction element seat3220of the improved plunger and damper assembly3160and the forward end of the improved plunger and damper assembly3160is still inserted into syringe242, such that forward dampening element3176is disposed in a friction-fit interference with the inner surface3162of the syringe242.

It is particularly seen inFIG. 10Bthat during forward displacement of the medicament module200relative to the improved plunger and damper assembly3160, forward dampening element3176is urged into engagement with rearwardly facing surface3226of forward damping control friction element seat3220by means of friction-fit engagement of the forward dampening element3176with the inner surface3162of the syringe242, as shown in stage II inFIGS. 6A & 6B.

It is noted that in this particular embodiment of the present invention, the forward dampening element3176is an O-ring, however it may alternatively be any other resilient element that provides for friction-fit interference between the improved plunger and damper assembly3160and the inner surface3162of the syringe242.

It is seen inFIG. 10Bthat in this operative orientation the piston243is more forwardly spaced from the contact portion3186of the improved plunger and damper assembly3160in comparison withFIG. 9B, such that there is no contact between the contact surface3186and the piston243.

It is a particular feature of an embodiment of the present invention that when the medicament module200is displaced forwardly with respect to the improved plunger and damper assembly3160, air can be released from the space between the contact portion3186and the piston243through recess3232thus relieving air pressure within this space and minimizing the air pressure resistance for removing the medicament module200from the automatic injection device100.

It is appreciated that, as seen inFIG. 10B, engagement of forward dampening element3176with the rearwardly facing surface3226of forward damping control friction element seat3220decreases the amount of friction forces during forward displacement of the medicament module200relative to the improved plunger and damper assembly3160as seen in stage II inFIGS. 6A & 6B. Upon engagement of forward dampening element3176with the rearwardly facing surface3226of forward damping control friction element seat3220, clearance is formed underneath the forward dampening element3176, which causes minimization of the forward dampening element3176profile. Profile minimization or shrinkage of the forward dampening element3176provides for smaller contact surface between the forward dampening element3176and the inner surface3162of the syringe242, which in turn provides for lower friction forces therebetween, which facilitates removal of the medicament module200from the automatic injection device100.

Reference is now made toFIGS. 11A-11C, which are respectively a simplified pictorial illustration, a side view and a sectional illustration of an improved plunger and damper assembly useful in various automatic injection devices, such as shown inFIGS. 1A& B and constructed and operative in accordance with another embodiment of the present invention, section being taken along lines C-C inFIG. 11B.

An improved plunger and damper assembly4160having a plunger and damper body4170is seen inFIGS. 11A-11C, being constructed and operative in accordance with another embodiment of the present invention. It is noted that the improved plunger and damper assembly4160is preferably identical in all respects to the improved plunger and damper assembly3160as shown and described with respect toFIGS. 2-4Chereinabove and identical reference numerals are used to indicate identical parts of the improved plunger and damper assembly3160and4160, with the exception of the following:

Instead of the forward dampening element3176in a form of an O-ring, a generally annular forward resilient dampening element4176is formed at a forward end of the plunger and damper body4170, within forward damping control friction element seat3220, typically adjacent the contact surface3186and being typically formed by overmolding. It is noted that the forward resilient dampening element4176extends radially outwardly with respect to the outer surface of longitudinal rod3182of the plunger and damper body4170.

It is noted that the annular forward resilient dampening element4176is generally fixedly attached to the plunger and damper body4170and radially extends outwardly with respect to the circumference of the plunger and damper body4170.

It is further seen inFIGS. 11A-11Cthat at least one channel4180is formed in forward resilient dampening element4176and extends generally longitudinally from circular cylindrical portion3184towards the half-circular section3214. The circular cylindrical portion3184preferably includes flat wall surface3188, which is generally aligned with channel4180.

It is noted that, alternatively, series of forward resilient dampening elements4176can be formed at the forward end of longitudinal rod3182of the plunger and damper body4170.

It is further noted that, alternatively, the forward resilient dampening element4176can be formed without channel4180.

It is a particular feature of an embodiment of the present invention that forward resilient dampening element4176is integrally formed with the plunger and damper body4170and is configured to be inserted into syringe242such that forward resilient dampening element4176is disposed in a friction-fit interference with the inner surface3162of the syringe242.

It is noted that the forward resilient dampening element4176is configured to be deformed and thus provide a friction force, as shown with respect to forward dampening element3176both during forward and rearward displacement of the improved plunger and damper assembly4160.

Specifically, when the improved plunger and damper assembly4160is mounted within the automatic injection device100in a start of injection operative orientation as shown inFIGS. 9A & 9B, and the improved plunger and damper assembly4160is adapted to be forwardly displaced along axis3172, the forward resilient dampening element4176is disposed in a friction-fit engagement with the inner surface3162of the syringe242and provides damping of the forward displacement of the improved plunger and damper assembly4160relative to the syringe242. Such damping reduces the impact of the improved plunger and damper assembly4160on the piston243and thus minimizing the risk of breakage of the syringe242and the noise created by the impact.

It is an additional embodiment of the present invention that the forward dampening element4176further enables dampening the movement of the improved plunger and damper assembly3160before engagement between the improved plunger and damper assembly4160and the piston243, thereby minimizing the risk of syringe breakage, even if the improved plunger and damper assembly4160has to travel a substantial distance up until engagement with the piston243, such as in case of injecting a low volume dosage of medication, such as under 1.5 ml, for example.

It is a further particular feature of an embodiment of the present invention that during forward displacement of the improved plunger and damper assembly4160relative the syringe242, as shown inFIGS. 9A & 9B, the forward resilient dampening element4176is deformed due to its axial displacement along the inner surface3162of the syringe242. The deformation of the forward resilient dampening element causes enhanced friction between the improved plunger and damper assembly4176and the syringe242, thus providing a relatively high level of damping of axial motion of the improved plunger and damper assembly4160in forward motion.

It is a further particular feature of an embodiment of the present invention that during forward displacement of the improved plunger and damper assembly4160, air pressure is created between forward resilient dampening element4176and the inner surface3162of the syringe242, which enhances damping of forward axial displacement of the improved plunger and damper assembly4160relative to the syringe242.

It is a particular feature of an embodiment of the present invention that axial forward insertion of the plunger and damper body4170with the forward dampening element4176into the syringe242creates friction between the forward dampening element4176and the inner surface3162of the syringe242and also creates an at least temporary air spring between the forward dampening element4176and the piston243, wherein the friction and the air spring dampen motion of the plunger and damper body4170.

In accordance with an embodiment of the present invention, air can be released from the space formed between the forward dampening element4176and the piston243via channel4180.

It is noted that in accordance with an alternative embodiment of the present invention, there is no channel4180provided in forward dampening element4176. According to this embodiment, air is trapped between the forward dampening element4176and the piston243, since the forward dampening element4176is disposed in a sealing relationship with the inner surface3162of the syringe242. It is a particular feature of this alternative embodiment of the present invention that upon forward displacement of the improved plunger and damper assembly4160under the force of spring180, the pressure between the forward dampening element4176and the piston243builds up, thus causing advancement of piston243relative to syringe242without any mechanical contact between the contact surface3186of the plunger and damper body4170and the piston243. It is noted that in accordance with an embodiment of the present invention, the injection of medicament contained within syringe242may begin before engagement of the improved plunger and damper assembly4160and the piston243.

When the improved plunger and damper assembly4160is mounted within the automatic injection device100in the removal from the injection site operative orientation as shown inFIGS. 10A-10C, and the improved plunger and the syringe242is displaced forwardly relative to the damper assembly4160, the forward resilient dampening element4176is still disposed in a friction-fit engagement with the inner surface3162of the syringe242.

It is noted that the air release is dependent on the existence and size of channel4180. In an alternative embodiment, the channel4180may be eliminated from the forward resilient dampening element4176.

Reference is now made toFIGS. 12A-12C, which are respectively a simplified pictorial illustration, a side view and a sectional illustration of an improved plunger and damper assembly useful in various automatic injection devices, such as shown inFIGS. 1A& B and constructed and operative in accordance with still another embodiment of the present invention, section being taken along lines C-C inFIG. 12B.

An improved plunger and damper assembly5160having a plunger and damper body5170is seen inFIGS. 12A-12C, being constructed and operative in accordance with another embodiment of the present invention. It is noted that the improved plunger and damper assembly5160is preferably identical in all respects to the improved plunger and damper assembly4160as shown and described with respect toFIGS. 11A-11Chereinabove and identical reference numerals are used to indicate identical parts of the improved plunger and damper assembly4160and5160, with the exception of the following:

Instead of the forward dampening element4176in a form of generally annular forward resilient dampening element, a generally rubber-edged blade set forward resilient dampening element5176is formed at a forward end of the plunger and damper body5170, within forward damping control friction element seat3220, typically adjacent the contact surface3186and being typically formed by overmolding. It is noted that the rubber-edged blade set forward resilient dampening element5176extends radially outwardly with respect to the outer surface of longitudinal rod3182of the plunger and damper body5170.

It is noted that the forward resilient dampening element5176is generally fixedly attached to the plunger and damper body5170and radially extends outwardly with respect to the circumference of the plunger and damper body5170.

It is further seen inFIGS. 12A-12Cthat the rubber-edged blade set forward resilient dampening element5176preferably includes one more circular resilient portions5178, which are generally axially spaced apart one from another and extends generally longitudinally from circular cylindrical portion3184towards the half-circular section3214.

It is noted that, alternatively, series of rubber-edged blade set forward resilient dampening element5176can be formed at the forward end of longitudinal rod3182of the plunger and damper body5170.

It is a particular feature of an embodiment of the present invention that rubber-edged blade set forward resilient dampening element5176is integrally formed with the plunger and damper body5170and is configured to be inserted into syringe242such that forward resilient dampening element5176is disposed in a friction-fit interference with the inner surface3162of the syringe242.

It is noted that flat wall surface3188is provided in the cylindrical portion3184of plunger and damper body5170, thus forming a recess therein. Corresponding recess may be provided on the resilient portions5178, or the resilient portions5178may be not fully-circumferential, leaving passage for air, and thus air which would otherwise be trapped between the contact surface3186and the piston243of the syringe242is released via these recesses.

It is noted that the rubber-edged blade set forward resilient dampening element5176is configured to be deformed and thus provide a friction force both during forward and rearward displacement of the improved plunger and damper assembly5160. The forward resilient dampening element5176at least temporarily seals the volume therebetween and between the piston243, thus creating pressure build-up between the forward resilient dampening element5176and the piston243. Upon reaching a sufficient pressure level, the forward resilient dampening element5176is deformed such that the resilient portions5178are deflected inwardly, thus allow partial air release from the volume enclosed between the forward resilient dampening element5176and the piston243.

Specifically, when the improved plunger and damper assembly5160is mounted within the automatic injection device100in a start of injection operative orientation as shown inFIGS. 9A & 9B, and the improved plunger and damper assembly5160is adapted to be forwardly displaced along axis3172, the rubber-edged blade set forward resilient dampening element5176is disposed in a friction-fit engagement with the inner surface3162of the syringe242and provides damping of the forward displacement of the improved plunger and damper assembly5160relative to the syringe242. Such damping reduces the impact of the improved plunger and damper assembly5160on the piston243and thus minimizing the risk of breakage of the syringe242and the noise created by the impact.

It is an additional embodiment of the present invention that the forward dampening element5176further enables dampening the movement of the improved plunger and damper assembly5160before engagement between the improved plunger and damper assembly5160and the piston243, thereby minimizing the risk of syringe breakage, even if the improved plunger and damper assembly5160has to travel a substantial distance up until engagement with the piston243, such as in case of injecting a low volume dosage of medication, such as under 1.5 ml, for example.

It is a further particular feature of an embodiment of the present invention that during forward displacement of the improved plunger and damper assembly5160relative the syringe242, as shown inFIGS. 9A & 9B, the resilient portions5178of rubber-edged blade set forward resilient dampening element5176are deformed due to their axial displacement along the inner surface3162of the syringe242. The deformation of resilient portions5178of the rubber-edged blade set forward resilient dampening element5176causes enhanced friction between the improved plunger and damper assembly5176and the syringe242, thus providing a relatively high level of damping of axial motion of the improved plunger and damper assembly5160in forward motion.

It is a particular feature of an embodiment of the present invention that axial forward insertion of the plunger and damper body5170with the forward dampening element5176into the syringe242creates friction between the forward dampening element5176and the inner surface3162of the syringe242and also creates an at least temporary air spring between the forward dampening element5176and the piston243, wherein the friction and the air spring dampen motion of the plunger and damper body5170.

It is a further particular feature of an embodiment of the present invention that during forward displacement of the improved plunger and damper assembly5160, air pressure is created between rubber-edged blade set forward resilient dampening element5176and the piston243, which enhances damping of forward axial displacement of the improved plunger and damper assembly5160relative to the syringe242. When the improved plunger and damper assembly5160is mounted within the automatic injection device100in the removal from injection site operative orientation as shown inFIGS. 10A-10C, and the syringe242is forwardly displaced relative to the improved plunger and damper assembly5160along axis3172, the rubber-edged blade set forward resilient dampening element5176is still disposed in a friction-fit engagement with the inner surface3162of the syringe242.

It is noted that air pressure between the plunger and damper body5170and the piston243can be released by inward deflection of resilient portions5178during injection of medicament.

Reference is now made toFIGS. 13A-13C, which are respectively a simplified pictorial illustration, a side view and a sectional illustration of an improved plunger and damper assembly useful in various automatic injection devices, such as shown inFIGS. 1A& B and constructed and operative in accordance with yet another embodiment of the present invention, section being taken along lines C-C inFIG. 13B.

An improved plunger and damper assembly6160having a plunger and damper body6170is seen inFIGS. 13A-13C, being constructed and operative in accordance with another embodiment of the present invention. It is noted that the improved plunger and damper assembly6160is preferably identical in all respects to the improved plunger and damper assembly4160as shown and described with respect toFIGS. 11A-11Chereinabove and identical reference numerals are used to indicate identical parts of the improved plunger and damper assembly4160and6160, with the exception of the following:

The improved plunger and damper assembly6160is not integrally made, rather it includes a plunger and damper body6170having a forwardly facing surface6171and a separate forward dampening portion6172having a cylindrical rod portion6173and a rearwardly facing surface6174. A generally annular forward resilient dampening element6176is formed at the forward dampening portion6172of the improved plunger and damper assembly6160, within forward damping control friction element seat3220, typically adjacent the contact surface3186and being typically formed by overmolding. It is noted that the forward resilient dampening element6176extends radially outwardly with respect to the outer surface of cylindrical rod portion6173of the forward dampening portion6172.

It is further seen inFIGS. 13A-13Cthat at least one channel6180is formed in forward resilient dampening element6176and extends generally longitudinally along the forward resilient dampening element6176.

It is noted that the annular forward resilient dampening element6176is generally fixedly attached to the forward dampening portion6172and radially extends outwardly with respect to the circumference of the forward dampening portion6172.

It is noted that, alternatively, series of forward resilient dampening elements6176can be formed at the forward dampening portion6172of the improved plunger and damper assembly6160.

It is further noted that, alternatively, the forward resilient dampening element6176can be formed without channel6180.

It is a particular feature of an embodiment of the present invention that both the plunger and damper body6170and the forward dampening portion6172with forward resilient dampening element6176are configured to be inserted into syringe242such that forward resilient dampening element6176is disposed in a friction-fit interference with the inner surface3162of the syringe242.

It is a particular feature of an embodiment of the present invention that a forward dampening portion6172is disposed within the syringe242between the piston243and the plunger and damper body6170and is spaced apart from both the piston243and the forwardly facing surface6171of the plunger and damper body6170. The forward end of the plunger and damper body6170is inserted into syringe242, and the forward dampening portion6172is disposed forwardly thereof and in a friction-fit interference with the inner surface3162of syringe242.

When the improved plunger and damper assembly6160is mounted within the automatic injection device100in a start of injection operative orientation as shown inFIGS. 9A & 9B, and the improved plunger and damper assembly6160is adapted to be forwardly displaced along axis3172, the forward resilient dampening element6176is disposed in a friction-fit engagement with the inner surface3162of the syringe242and provides damping of the forward displacement of the improved plunger and damper assembly6160relative to the syringe242. Such damping reduces the impact of the improved plunger and damper assembly6160on the piston243and thus minimizing the risk of breakage of the syringe242and the noise created by the impact.

It is an additional embodiment of the present invention that the forward dampening element6176further enables dampening the movement of the improved plunger and damper assembly6160before engagement between the improved plunger and damper assembly6160and the piston243, thereby minimizing the risk of syringe breakage, even if the improved plunger and damper assembly6160and the forward dampening portion6172has to travel a substantial distance up until engagement with the piston243, such as in case of injecting a low volume dosage of medication, such as under 1.5 ml, for example.

It is a further particular feature of an embodiment of the present invention that during forward displacement of the improved plunger and damper assembly6160relative the syringe242, as shown inFIGS. 9A & 9B, the forward resilient dampening element6176provides friction forces due to its axial displacement along the inner surface3162of the syringe242. The forward resilient dampening element6176provides for damping of axial motion of the improved plunger and damper assembly6160in forward motion.

It is a further particular feature of an embodiment of the present invention that in absence of channel6180, air pressure is created between forward resilient dampening element6176and the piston243during forward displacement of the improved plunger and damper assembly6160, which enhances damping of forward axial displacement of the improved plunger and damper assembly6160relative to the syringe242.

It is a particular feature of an embodiment of the present invention that axial forward insertion of the plunger and damper body6170with the forward dampening element6176into the syringe242creates friction between the forward dampening element6176and the inner surface3162of the syringe242and also creates an at least temporary air spring between the forward dampening element6176and the piston243, wherein the friction and the air spring dampen motion of the plunger and damper body6170.

It is noted that in accordance with an alternative embodiment of the present invention, there is no channel6180provided in forward dampening element6176. According to this embodiment, air is trapped between the forward dampening element6176and the piston243, since the forward dampening element6176is disposed in a sealing relationship with the inner surface3162of the syringe242. It is a particular feature of this alternative embodiment of the present invention that upon forward displacement of the improved plunger and damper assembly4160under the force of spring180, the pressure between the forward dampening element6176and the piston243builds up, thus causing advancement of piston243relative to syringe242without any mechanical contact between the contact surface3186of the forward dampening portion6172and the piston243. It is noted that in accordance with an embodiment of the present invention, the injection of medicament contained within syringe242may begin before engagement of the improved plunger and damper assembly6160and the piston243.

It is further noted that if channel6180is provided on the forward dampening element6176, then air pressure from the space between the forward dampening portion6172and the piston243is released via channel6180.

It is noted that the air release is dependent on the existence and size of channel6180. In an alternative embodiment, the channel6180may be eliminated from the forward resilient dampening element6176.

It is further noted that any one of forward dampening elements3176(shown inFIGS. 6A & 6B),4176(shown inFIGS. 11A-11C),5176(shown inFIGS. 12A-12C), or6176(shown inFIGS. 13A-13C), can be used in conjunction with rearward dampening element3174(shown inFIGS. 5A & 5B). Additionally, any one of forward dampening elements3176,4176or5176can be mounted on the forward dampening portion6172, which is illustrated and described in detail with reference toFIGS. 13A-13C.

Reference is now made toFIG. 14, which is a simplified drawing illustrating the automatic injection device100ofFIGS. 1A & 1Band an improved medicament module just prior to operative engagement of the improved medicament module with the automatic injection device100.

It is seen inFIG. 14that an improved medicament module7000can be inserted into operative engagement with the automatic injection device100ofFIGS. 1A & 1B.

All components of the automatic injection device100are preferably identical to that shown inFIGS. 1A & 1Bof PCT Patent application PCT/IL2016/050929 and described therein, the improved medicament module7000is similar to that shown inFIGS. 2A & 2Bof PCT Patent application PCT/IL2016/050929, but is different therefrom in various aspects which are described in detail hereinbelow. The disclosure of PCT Patent application PCT/IL2016/050929 is hereby incorporated by reference.

Preferably, the automatic injection device100is reusable and the improved medicament module7000is disposable. Alternatively, both the automatic injection device100and the improved medicament module7000are disposable. Further alternatively, both the automatic injection device100and the improved medicament module7000are reusable. It is noted that both the automatic injection device100and the improved medicament module7000are mutually disposed along longitudinal axis190.

Reference is now made toFIGS. 15A and 15B, which are respectively simplified assembled view and exploded view pictorial illustrations of the improved medicament module7000constructed and operative in accordance with an embodiment of the present invention and usable in conjunction with the reusable automatic injection device100such as that illustrated inFIGS. 1A & 1B.

As seen inFIGS. 15A and 15B, the improved medicament module7000comprises an RNS remover assembly7010, a needle shield7020, and a module housing7030, which partially encloses the needle shield7020, all mutually arranged along longitudinal axis190. The improved medicament module7000is adapted to receive a syringe242having a piston243contained therein and removable needle cover244surrounding a needle246, which extends forwardly of a syringe flange248, such as described in detail with reference toFIGS. 1A & 1B.

It is appreciated that syringe242can be any type of a medicament container, such as pre-filled syringe, cartridge.

Reference is now made toFIGS. 16A, 16B, 16C, 16D, 16E, 16F, 16G and 16H, which are simplified respective perspective, top and bottom view, side view, first and second end view and three sectional illustrations taken along lines F-F inFIG. 16B, lines G-G inFIG. 16Cand line H-H inFIG. 16Bof the module housing7030, forming part of the improved medicament module7000ofFIGS. 15A & 15B.

As seen inFIGS. 16A-16H, the module housing7030preferably is an integrally formed element, preferably injection molded of plastic and preferably has a generally cylindrical configuration including a generally tubular portion7101, which defines backward-facing generally symmetric edges7102having generally symmetric top/bottom facing windows7104and forward-facing generally symmetric edges7105. Top-bottom facing windows7104may be obviated, if module housing7030is formed of a transparent material. Generally forwardly of edges7102are a pair of inwardly directed partially azimuthal bulkheads7106, having rearwardly-facing surfaces7108.

Module housing7030is preferably side-to-side symmetric about longitudinal axis190. Module housing7030is preferably formed with a central, generally circular cylindrical portion7112and a pair of generally symmetric side-disposed longitudinal wall portions7114extending from backward-facing generally symmetric edges7102to forward-facing generally symmetric edges7105.

Fingers7116and7118extend forwardly in respective cut outs7126and7128formed in longitudinal wall portions7114and parallel to longitudinal axis190, each of fingers7116and7118preferably terminating in side-to-side facing protrusions7120and7122.

Longitudinal wall portions7114preferably each terminate rearwardly at a rearward edge7123, which defines a generally rectangular cut-out7129.

A pair of mutually spaced longitudinal ribs7130and7132are formed on opposite sides of each of the wall portions7114. Ribs7130and7132each define, together with an adjacent respective mutually facing rib7140and7142a longitudinal channel. The channels are respective designated by reference numerals7150,7152,7154and7156.

First slots7160and7162are formed along channels7152and7156respectively and second slots7164and7166are defined along channels7150and7154respectively. First slots7160and7162are generally T-shaped, such that each includes a longitudinal portion7170having a forward facing edge7172and a rearward facing edge7174and a lateral portion7176generally transversely extending from the longitudinal portion7170, The lateral portion7176has an inwardly facing edge7178.

An aperture7180is formed slightly forwardly of and spaced from the forward facing edge7172. A protrusion7181is formed between slot7160and aperture7180.

Second slots7164and7166each include a forward facing edge7182and a rearward facing edge7184.

A pair of inwardly directed side protrusions7190and7192extend inwardly from each of arms7116and7118in a plane perpendicular to axis190and each define a generally circular inwardly facing edge7194.

Reference is now made toFIGS. 17A, 17B, 17C, 17D, 17E, 17F, 17G and 17H, which are simplified respective perspective, top and bottom view, side view, first and second end view and three sectional illustrations taken along lines F-F inFIG. 17B, lines G-G inFIG. 17Cand lines H-H inFIG. 17Bof the needle shield7020, forming part of the improved medicament module7000ofFIGS. 15A & 15B.

As seen inFIGS. 17A-17H, needle shield7020preferably is an integrally formed element, preferably injection molded of plastic and preferably has a generally cylindrical configuration arranged about a longitudinal axis190.

Needle shield7020preferably includes a generally conical tubular portion7211terminating at a partially circumferential rim7212extending radially outwardly therefrom and defining a generally circular cylindrical hollow bore. Generally conical tubular portion7211preferably defines a plurality of generally longitudinal guide surfaces7215which serve to guide the axial travel of a syringe therein. Needle shield7020preferably includes a pair of side mounting arms7218and7220, extending rearwardly from tubular portion7211and having respective rearward facing edges7222and7224.

Adjacent each of rearward facing edges7222and7224there is preferably formed an inwardly directed toothed syringe retaining protrusion7225.

Each of mounting arms7218and7220is formed with a generally U-shaped outer facing protrusion7226adjacent respective edges7222and7224. Each of mounting arms7218and7220is formed with a rearward-facing flexible finger7228, a forward recess7229located between the flexible finger7228and the circumferential rim7212and a rearward slot7230as well as a pair of narrow slots7231and7232, forwardly of which are formed tapered surfaces7233and7234respectively. The forward recess7229has a forward tapered surface7235.

Rearward-facing flexible finger7228preferably is formed with an outwardly-facing protrusion7236having a forwardly-facing tapered surface7238and a rearwardly-facing tapered surface7240joined at an outermost flat surface7242.

Each of mounting arms7218and7220is preferably formed with an axial inwardly-facing surface7243, which together with side ribs7244defines a channel7245.

Mounting arm7218is formed with respective forward and rearward resilient finger portions7246and7248. Mounting arm7220is formed with respective forward and rearward resilient finger portions7250and7252. Finger portions7248and7252each include an outwardly-facing protrusion7260having a forward-facing surface7262, a rearward-facing tapered surface7264and a rearward facing edge7266. A protrusion7268is slightly forwardly spaced from protrusion7260.

A forwardly tapered surface7290connects each of the respective edges7222and7224with the respective one of protrusions7225.

A generally U-shaped aperture7292is formed between finger portion7246and7252. A similar U-shaped aperture7292is formed between finger portion7248and7250. It is seen inFIGS. 17A-17Gthat side mounting arms7218and7220preferably respectively extend from rearward extending edges7222and7224to circumferential rim7212. A rearwardly extending recess7294is formed at the forward ends of side mounting arms7218and7220, located adjacent the circumferential rim7212.

Reference is now made toFIGS. 18A and 18B, which are respectively simplified assembled view and exploded view pictorial illustrations of the RNS remover assembly7010, forming part of the improved medicament module7000ofFIGS. 15A & 15Band toFIGS. 19A & 19B, which are simplified respective pictorial and sectional illustrations of an outer portion of the RNS remover assembly7010ofFIGS. 18A & 18B, section being taken along lines B-B inFIG. 19Aand toFIGS. 20A & 20B, which are simplified respective pictorial and sectional illustrations of an inner portion of the RNS remover assembly7010ofFIGS. 18A & 18B, section being taken along lines B-B inFIG. 20A. Reference is additionally made toFIGS. 21A, 21B, 21C, and 21D, which are simplified respective first and second perspective views, end view and a sectional view taken along lines D-D inFIG. 21Cof the assembled RNS remover assembly, forming part of the improved medicament module7000ofFIGS. 15A & 15B.

As seen inFIGS. 18A-21D, the RNS remover assembly7010is preferably comprised of an outer portion7400and an inner portion7410, both of which are integrally formed elements preferably injection molded of plastic.

The outer portion7400, seen specifically inFIGS. 19A & 19B, includes a generally tubular portion7420arranged along a longitudinal axis7421extending rearwardly from a base wall7424. A generally forwardly extending circumferential protrusion7426has a generally oval cross-section and extends forwardly from base wall7424and along a certain longitudinal extent of the tubular portion7420.

The outer portion7400has a pair of rearwardly extending arms7430, each of which extends rearwardly of the generally tubular portion7420to a rearwardmost edge surface7432. Arms7430are each formed with resilient fingers7434disposed generally adjacent the base wall7424. An inwardly extending protrusion7436is formed on the inside of each of the resilient fingers7434, the protrusion has a rearwardly-facing angled edge7438and a forwardly-facing angled edge7440. Radially outwardly extending generally U-shaped protrusions7444are formed partially around the outside perimeter of each of the resilient fingers7434.

A pair of radially outwardly extending protrusions7450extend outwardly from each of arms7430and located between the U-shaped protrusions7444and the rearwardmost end7432of arms7430. The protrusions7450include a forwardly tapered surface7452, a rearwardly tapered surface7454and a flat surface7456connecting therebetween. An opening7460is formed through the pair of protrusions7450and extends into an inner volume7462that is formed by an imaginary circumference formed by the arms7430.

There are two openings7470formed through the base wall7424. The openings7470are generally spaced from each other, forming a bridge7472therebetween. Another two openings7474, each formed on one side of each of openings7470.

Two ear portions7476that are generally diametrically opposed to each other are formed on two opposite sides of the base wall7424.

The tubular portion7420has a generally annular radially inwardly extending protrusion7478including a forwardly facing circular edge7480, which is rearwardly spaced from the base wall7424.

The inner portion7410, seen specifically inFIGS. 20A & 20B, includes a generally tubular cylindrical portion7500and two arms7502which are mutually diametrically opposed to each other and extend rearwardly from the cylindrical portion7500to a rearward edge7504. The imaginary diameter formed by the two arms7502is generally greater than the diameter of the cylindrical portion7500.

A resilient finger7510is formed on each arm7502and extend forwardly from a location adjacent the rearward edge7504. Each of the resilient fingers7510has a radially inwardly extending protrusion7512, having a rearward tapered surface7514and a forwardly facing surface7516.

The cylindrical portion7500has a forward end wall7518. A circumferential opening7520is formed through the cylindrical portion7500and revolves about the longitudinal axis7421. An anchor-shaped resilient protrusion7530extends rearwardly from the forward end wall7518. The anchor-shaped resilient protrusion7530has a central portion7532and two mutually opposed side extensions7534, each having a radially outwardly extending protrusion7536that has a rearwardly facing surface7538.

It is particularly seen inFIG. 21Dthat the inner portion7410is partially inserted into the inner volume7462of the outer portion7400, specifically the cylindrical portion7500of the inner portion7410is inserted into the tubular portion7420of the outer portion7400.

It is a particular feature of an embodiment of the present invention that the anchor-shaped resilient protrusion7530of the inner portion7410is snapped behind protrusion7478of the tubular portion7420of the outer portion7400, such that rearwardly facing surface7538of resilient protrusion7530is snapped behind forwardly facing circular edge7480of protrusion7478. The inner portion7410is freely slidable with respect to the outer portion7400along longitudinal axis7421between two operative positions. First operative position is when forward end wall7518of the inner portion engages the base wall7424of the outer portion7400. Second operative position is when rearwardly facing surface7538of resilient protrusion7530is snapped behind forwardly facing circular edge7480of protrusion7478.

Reference is now made toFIGS. 22A and 22B, which are two different simplified plan views of the assembled improved medicament module7000ofFIGS. 15A & 15Bin a storage operative orientation, showing the RNS remover assembly7010ofFIGS. 18A & 18Battached to the needle shield7020ofFIGS. 17A-17H. Reference is additionally made toFIGS. 22C and 22D, which are two orthogonal section views taken along lines C-C inFIG. 22Aand lines D-D inFIG. 22Bof the assembled improved medicament module7000in the operative orientation shown inFIGS. 22A & 22B.

As seen particularly inFIGS. 22A-22D, needle shield7020is located generally inside and coaxial with module housing7030, arranged along mutual longitudinal axis190.

It is also seen that in a “storage” operative orientation, when the RNS remover assembly7010is attached to the needle shield7020, that the needle shield7020, is fixedly retained in the module housing7030against axial relative movement therebetween. Needle shield7020is retained against forward axial displacement relative to module housing7030along axis190by engagement of protrusions7226at the rearward end of the needle shield7020in cutouts7129at the edge7123of the module housing7030.

It is additionally seen that syringe242is fixedly retained against rearward axial motion along axis190relative to needle shield7020and module housing7030by engagement of protrusion7225of needle shield7020with flange248of syringe242.

It is further noted that syringe242is fixedly retained against forward axial motion along axis190relative to needle shield7020and module housing7030by engagement of flange248of syringe242with rearwardly-facing surfaces7108of bulkheads7106of module housing7030.

It is seen inFIGS. 22A-22Dthat needle shield7020is retained against forward or rearward axial displacement relative to module housing7030along longitudinal axis190by engagement of protrusions7260of finger protrusions7248and7252of needle shield7020in slots7160of the module housing7030and protrusions7260are safely held within slots7160due to engagement of protrusion7181of the module housing7030in between protrusion7260and protrusion7268of the needle shield7020. Additionally, needle shield7020is retained against rearward or forward axial displacement relative to module housing7030along axis190by engagement of protrusions7280of finger portions7246and7250of needle shield7020in slots7164of the module housing7030.

Additionally, it is seen that protrusions7190and7192of arms7116and7118respectively of module housing7030are seated in narrow slots7231and7232of the needle shield7020.

It is a particular feature of an embodiment of the present invention that in this storage operative orientation, inwardly directed side protrusions7190and7192of each of fingers7116and7118of the module housing7030are inserted into respective narrow slots7231and7232of the needle shield7020. As seen inFIGS. 22A-22D, the rearwardmost edge surface7432of the outer portion7400of the RNS remover assembly7010abuts the forward-facing generally symmetric edges7105of the module housing7030, thus contributing to the fact that the inwardly directed side protrusions7190and7192cannot disengage from narrow slots7231and7232of needle shield7020upon application of force on the improved medicament module7000in either direction.

It is also seen that RNS remover assembly7010is located generally forwardly of the module housing7030and both inside and outside of needle shield7020and coaxially therewith such that, respective axes190and7421are coaxial. More specifically, two arm portions7502of the inner portion7410of RNS remover assembly7010is located in the generally circular cylindrical hollow bore of needle shield7020. Arm portions7502of the inner portion7410of RNS remover assembly7010generally surrounds and attachably engages removable needle cover244by virtue of the engagement of inwardly directed protrusions7512of the inner portion7410of RNS remover assembly7010with a rearward edge of removable needle cover244.

As mentioned above with respect toFIGS. 21A-21D, anchor-shaped resilient protrusion7530of the inner portion7410is snapped behind protrusion7478of the outer portion7400, such that rearwardly facing surface7538of resilient protrusion7530is snapped behind forwardly facing circular edge7480of protrusion7478. The inner portion7410is freely slidable with respect to the outer portion7400along longitudinal axis7421between two positions. First position is when forward end wall7518of the inner portion engages the base wall7424of the outer portion7400. Second position is when rearwardly facing surface7538of resilient protrusion7530is snapped behind forwardly facing circular edge7480of protrusion7478. Slidable displacement of the anchor-shaped resilient protrusion7530ensures positive engagement of the protrusions7512of the inner portion7410of RNS remover assembly7010and thus in turn ensures the removal of the removable needle cover244upon detachment of the RNS remover assembly7010from the improved medicament module7000, as described in detail hereinbelow.

It is a particular feature of an embodiment of the present invention, as seen specifically inFIG. 22C, that protrusions7436of the resilient fingers7434of the outer portion7400of the RNS remover assembly7010are inserted and held within forward recesses7229of the needle shield7020, by means of engagement of forwardly facing angled edges7440of the outer portion7400of the RNS remover assembly7010with the forward tapered surfaces7235of recesses7229of the needle shield7020.

It is further seen that protrusions7236of rearward-facing flexible fingers7228of needle shield7020are seated in corresponding openings7460of the outer portion7400of the RNS remover assembly7010, thereby locking the needle shield7020to the RNS remover assembly7020.

Reference is now made toFIGS. 23A and 23B, which are respectively simplified pictorial and section view illustrations of the improved medicament module ofFIGS. 15A & 15B, showing the RNS remover assembly7010ofFIGS. 18A & 18Bdetached from the needle shield7020ofFIGS. 17A-17H, section being taken along lines B-B inFIG. 23A.

As seen inFIGS. 23A and 23B, when the RNS remover assembly7010(FIGS. 21A-21D) is detached from the needle shield7020of the improved medicament module7000, as by axial forward pulling of the RNS remover assembly7010along axis190, which is enabled by disengagement of outwardly-facing protrusions7236of needle shield7020from openings7460of RNS remover assembly7010. It is a particular feature of an embodiment of the present invention that this disengagement is only possible when the improved medicament module7000and the reusable automatic injection assembly100are in an axial operative orientation corresponding to that shown inFIGS. 45A-45Dof PCT Patent application PCT/IL2016/050929, which is incorporated by reference herein, such that ribs1315(FIGS. 21A-21Gof PCT Patent application PCT/IL2016/050929), engage protrusions7236(FIGS. 22A-22D).

The removable needle cover244is retained interiorly of the inner portion7410of the RNS remover assembly7010, preferably by engagement of inwardly directed protrusions7512of arms7502of the inner portion7410of the RNS remover assembly7010with a rearward-facing edge or adjacent to this edge of the removable needle cover244.

It is a particular feature of an embodiment of the present invention that notwithstanding the exact location of the protrusion7512of the inner portion740of the RNS remover assembly7010relative to the rearward edge of the removable needle cover244, the removable needle cover244is removed in all instances due to the slidable displacement of the inner portion7410relative the outer portion7400of the RNS remover assembly7010. This relative displacement between the two portions of the RNS remover assembly7010compensates for any manufacturing tolerances that may cause dimensional incompatibility between the removable needle cover244and the RNS remover assembly7010.

It is a particular feature of an embodiment of the present invention, as seen specifically inFIG. 23C, that upon application of force on the RNS remover assembly7010in a direction indicated by arrow7590, protrusions7436of the resilient fingers7434of the outer portion7400of the RNS remover assembly7010are disengaged from forward recesses7229of the needle shield7020, by means of rearward slidable displacement of forwardly facing angled edges7440of the outer portion7400of the RNS remover assembly7010rearwardly over the forward tapered surfaces7235of recesses7229of the needle shield7020. It is noted that rearward displacement of protrusions7436of the resilient fingers7434of the outer portion7400of the RNS remover assembly7010relative to forward tapered surfaces7235of recesses7229of the needle shield7020is facilitated by the fact that both forwardly facing angled edges7440and forward tapered surfaces7235are angled in the same direction.

Reference is now made toFIGS. 24A and 24B, which are respectively simplified pictorial and section view illustrations of the improved medicament module7000ofFIGS. 15A & 15B, shown in a mis-use orientation of the improved medicament module7000associated with the automatic injection device100ofFIGS. 1A & 1B, when the user attempts to re-attach the RNS remover assembly7010back onto the needle shield7020ofFIGS. 17A-17Hof the improved medicament module7000, section being taken along lines B-B inFIG. 24A.

An undesirable orientation is seen inFIGS. 24A and 24B, in which the user attempts to insert the RNS remover assembly7010back into the improved medicament module7000after it was already removed from it. It is appreciated that in this mis-use orientation, the user may attempt to charge a used medicament module7000into the reusable automatic injection assembly100and it is desirable to prevent such charging, thus the following structural relationships exist:

It is a particular feature of an embodiment of the present invention and is seen inFIG. 24Bthat attachment of the RNS remover assembly7010to the needle shield7020of the improved medicament module7000is prevented following detachment thereof. Once the RNS remover assembly7010is pushed rearwardly with respect to the module housing7030and needle shield7020in the direction indicated by arrow7600, in attempt to re-attach the RNS remover assembly7010back to the needle shield7020of the improved medicament module7000, it is prevented from being re-attached back to the improved medicament module7000. The re-attachment of the RNS remover assembly7010to the needle shield7020of the improved medicament module7000is prevented by means of engagement of protrusions7436of the RNS remover assembly7010with circumferential rim7212of the needle shield7020, and specifically by means of engagement of rearwardly facing angled edges7438of protrusions7436with recesses7294formed in circumferential rim7212. In this operative orientation, protrusions7436are held securely by recesses7294and prevent rearward displacement of the RNS remover assembly7010relative to needle shield7020in the direction indicated by arrow7600.

It is a further particular feature of an embodiment of the present invention that due to engagement of protrusions7436with circumferential rim7212of the needle shield7020, the protrusions7236of flexible fingers7228of needle shield7020are prevented from being inserted into openings7460of the RNS remover assembly7010.

It was previously described inFIGS. 64A-64Cof PCT Patent application PCT/IL2016/050929, which is incorporated by reference herein, that medicament module200/300without the RNS remover210cannot be charged into the automatic injection assembly100. Similarly, the improved medicament module7000cannot be charged into the automatic injection assembly100once the RNS remover assembly7010is removed therefrom and is prevented to be mounted back on to the improved medicament module7000, as described hereinabove.

It is a particular feature of an embodiment of the present invention that a gap is formed between the rearwardmost edge surface7432of the outer portion7400of the RNS remover assembly7010and the forward-facing generally symmetric edges7105of the module housing7030, such that the outer portion7400of the RNS remover assembly7010is forwardly spaced from the module housing7030and the user is not able to apply force on the module housing7030through the RNS remover assembly7010. This gap between the RNS remover assembly7010and the module housing7030is created due to engagement of inwardly-facing protrusions7436of the RNS remover assembly7010with the circumferential rim7212of the needle shield7020. It is mentioned hereinabove with reference toFIGS. 22A-22Dthat inwardly directed side protrusions7190and7192of each of fingers7116and7118of the module housing7030are inserted into respective narrow slots7231and7232of the needle shield7020.

It is previously described and illustrated with reference toFIGS. 22A-22Dthat the rearwardmost edge surface7432of the outer portion7400of the RNS remover assembly7010abuts the forward-facing generally symmetric edges7105of the module housing7030, thus the inwardly directed side protrusions7190and7192cannot disengage from narrow slots7231and7232of needle shield7020upon application of force on the improved medicament module7000in either direction.

In comparison, it is seen specifically inFIGS. 24A and 24Bthere is a gap between the RNS remover assembly7010and the module housing7030, thus upon application of longitudinal force on the improved medicament module7000, such as during pushing the improved medicament module7000into the automatic injection device100during charging, as shown inFIGS. 64A-64Cof PCT Patent application PCT/IL2016/050929, axial displacement between the module housing7030and the needle shield7020is permitted. This axial displacement causes disengagement of fingers7116and7118of the module housing7030from narrow slots7231and7232of the needle shield7020and thus in turn does not allow charging of a used improved medicament module7000into automatic injection device100, as described in detail with reference toFIGS. 64A-64Cof PCT Patent application PCT/IL2016/050929.

This invention generally relates to a reusable automatic injection device for parenteral administration of substances (e.g., a medication) to a living organism (human or animal). The administration may be delivered into the subcutaneous tissue.

The invention is further related to, but is not limited to a self-administration of patients with chronic diseases such as rheumatoid arthritis (RA), multiple sclerosis (MS), HIV, and growth hormone deficiency.

It is appreciated that in accordance with an embodiment of the present invention the medicament is enclosed in a pre-filled syringe, but it can alternatively be used with other drug enclosures such as vials or ampoules, where a vial adaptor or an ampoule adaptor is used to reconstitute, mix, or pump the drug into the syringe prior to injection. The pre-filled syringe can be either a conventional one chambered pre-filled syringe with a ready-to-inject liquid form drug, or it can be a multiple-chambered pre-filled syringe.

The reusable automatic injection device provides an automatic needle insertion through the skin, which therefore overcomes the main obstacle in self-administration, i.e., the needle phobia; the user does not see the needle through all the procedure, i.e., before, during and after injection.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been specifically shown and described hereinabove. Rather the scope of the invention includes both combinations and sub-combinations of features described and shown hereinabove as well as modifications thereof which would occur to persons reading the foregoing description and which are not in the prior art.