Autoinjector system

Abstract
An autoinjector system for injecting a fluid medicament into a patient includes a re-usable autoinjector, and a disposable cassette loaded with a hypodermic syringe pre-filled with a fluid medicament. The autoinjector includes a first motor for injecting a needle of the hypodermic syringe into the patient and a second motor for expelling the fluid medicament from the syringe.
Description
FIELD

The present disclosure relates to a system and method for injecting medicaments into a patient from a hypodermic syringe. More particularly, the present disclosure relates to an auto-injector and a cassette useable with the auto-injector, which conceals the injection needle of a hypodermic syringe before and after an injection.


BACKGROUND

Pre-filled hypodermic syringes provide several advantages for the home-use market. These advantages include that pre-filled syringes may be prepared for each medicament with exactly the required dosage. Further, they are easily operated, by merely advancing the stopper of the syringe. Aside from the costs of the particular medication that is being used, pre-filled syringes are also economically manufactured. Consequently, all these advantages make pre-filled syringes commercially appealing.


Nevertheless, pre-filled syringes also have a significant drawback in the marketplace. Specifically, many users are either frightened by an exposed needle or feel they are inherently incapable of performing an injection. Because of aversions to exposed needles, as well as the many health and safety issues that may be involved, various types of injectors and other devices have been developed for the specific purpose of concealing needles from the user and automating the injection task to assist the user in performing the injection.


In order to inject a fluid medicament into a patient when using a hypodermic syringe, generally three separate and distinct tasks must be performed. These are: 1) insertion of the needle into the patient; 2) injection of the fluid medicament from the syringe into the patient; and 3) withdrawal of the needle after the injection has been completed. For each task, the magnitude and direction of forces on the syringe, as well as the location of their application, are different from the other tasks. For instance, compare the task of inserting the needle, with the task of injecting the fluid medicament. Insertion of the needle requires that only minimal forces be applied on the syringe, and that they be applied for only a very short period of time. On the other hand, injection of the medicament requires a much greater force be applied. Further, this force must be applied on the plunger of the syringe for what will typically be a relatively longer period of time. In comparison with both of these tasks, needle withdrawal requires the application of a force in the opposite direction. These, and other similar considerations, become important when the injection process is to be automated.


Springs for generating forces on a syringe in an automated process have been used heretofore for various purposes. A characteristic of springs, however, is that the magnitude and direction of a spring force are not variable. Consequently, springs do not lend themselves for so-called multi-tasking operations. This is particularly so where precise control over a syringe injection operation is required, and different magnitude forces are sequentially required in the same direction (e.g. needle insertion and medicament injection). This can be particularly problematic in situations where it may be desirable to use the same device, at different times, to inject different medications, with different fluid viscosities.


In addition to the mechanical considerations mentioned above, the design of an auto-injector also requires user-friendly considerations. In particular, it is desirable that the injection needle of a syringe be operationally concealed from the view of a user. Preferably, this concealment may be maintained before, during and after an injection procedure. Further, it is desirable that operation of the syringe be limited to only those times when the syringe is properly positioned for an injection.


Accordingly, an improved medicament injection system is needed, which hides the syringe needle during use, is capable of accommodating different force requirements during an injection procedure, is relatively easy and inexpensive manufacture, and is easy to use.


SUMMARY

In accordance with the present disclosure, a system for injecting fluid medicaments into a patient from a pre-filled hypodermic syringe, employs a cassette that is pre-loaded with the pre-filled syringe. For this combination, the hypodermic syringe can be loaded into the cassette during manufacture, or be subsequently loaded by a contract service provider. In either case, the syringe needle is concealed inside the cassette and hidden from the view of the end-user. Importantly, the only preparation required by the end-user (e.g. the patient that is to self-administer the fluid medicament) is to mount the cassette onto a drive mechanism.


Structurally, the system of the present disclosure envisions a pr-filled syringe that will have a needle, and it will have a stopper for expelling the fluid medicament from the syringe through the needle. Further, the pre-filled syringe will be firmly held on the cassette in a position where the syringe needle is concealed and hidden from view. As envisioned for the present disclosure, the pre-filled hypodermic syringe can be firmly held in the concealed position, in any of several different ways. These include, the use of a latching mechanism, an adhesive, or a flexible abutment.


Once the cassette has been loaded with the pre-filled hypodermic syringe, the cassette can be engaged with a drive mechanism. In detail, the drive mechanism includes two separate motors that perform two different functions. A first motor is provided for engaging the syringe in its concealed position where its needle is hidden. With this engagement, the first motor then moves the syringe and its needle from the concealed position and into an exposed position where the needle is extended for insertion into the patient. While the needle is inserted into the patient, a second motor is provided for pushing the stopper on the syringe to expel fluid medicament from the syringe. After the injection has been completed, the first motor then withdraws the syringe and its needle back into the concealed position. Importantly, after it has been withdrawn the syringe is again firmly held in the concealed position, inside the cassette. Thus, the needle remains hidden from view at all times during an injection procedure. Further, as noted above, the syringe is firmly held inside the cassette to insure the syringe needle does not inadvertently extend from the cassette.


In operation, an end-user mounts a pre-loaded cassette on the drive mechanism. The end-user then removes a protective cover from the syringe needle and positions the system at a site where an injection is to be made. A button on the system is then pushed to activate the drive mechanism for an injector procedure. After the injection has been completed, the cassette, with its now empty syringe, can be removed from the drive mechanism and discarded.


In accordance with the present disclosure an autoinjector system includes a disposable cassette that operates in combination with a reusable injector. Prior to an engagement of the cassette with the injector, however, a pre-filled syringe is mounted and latched onto the cassette. When latched, the syringe is held on the cassette in a home position. For the present disclosure, this pre-filled syringe may be of any type syringe well-known in the pertinent art that has a fluid chamber with an injection needle at its distal end, and a plunger that can be advanced into the fluid chamber. When the cassette, with syringe, is engaged with the injector, the system is ready for use.


Operation of the system of the present disclosure requires two separate motors that are individually mounted on the injector. Though they are mechanically independent of each other, the respective operations of these two motors must be coordinated. Specifically, a first motor is used to effect movements of the entire syringe assembly (i.e. syringe chamber, injection needle and plunger are all moved together). On the other hand, a second motor is employed to advance the plunger into the fluid chamber for performing an injection of a fluid medicament.


In a duty cycle of the system, the first motor moves a drive rod into engagement with the syringe. With this engagement, the drive rod also releases the latch that otherwise holds the syringe in the home position. After the syringe has been released, the first motor then advances the syringe in a distal direction on the cassette. This movement inserts the injection needle into a patient. Further, the first motor can be used to abruptly stop the needle when a specified needle depth has been achieved. The first motor can then be used to help stabilize the needle during an injection of the medical medicament from the syringe.


As mentioned above, the injection of medical medicament from the syringe is accomplished using the second motor. In detail, once the needle has been properly inserted into the patient, the second motor moves a pusher to urge against the plunger of the syringe to advance the plunger into the fluid chamber of the syringe. Importantly, the second motor can be programmed to advance the plunger into the fluid chamber at a predetermined rate(s) for compliance with an injection protocol.


After the injection has been completed, the second motor withdraws the pusher. The first motor is then used again. Specifically, the first motor is now used to withdraw the injection needle from the patient, and to return the syringe to the home position on the cassette, where it is re-latched onto the cassette. The cassette can then be removed from the injector and discarded.


In order to control the concerted operations of the first and second motors, the system includes a microcomputer that is mounted on the injector. Importantly, the microcomputer operates the motors with different forces, and at different speeds for different purposes. More specifically, the first motor must operate quickly to insert the needle (e.g. about 0.1 meters/second (m/s) to 1.0 m/s), but it does not require much force to do so. Similarly, needle withdrawal by the first motor requires a minimal force. Unlike the first motor, however, the second motor will typically be required to generate greater forces for the injection of fluid medicament. And, accordingly, it will also typically operate at slower speeds. Further, and most importantly, different injections (i.e. advancements of the syringe plunger by the second motor) may require different injection rates. Thus, the second motor requires speed control provided by the microcomputer.


Together with the components mentioned above, the system of the present disclosure may employ a capacitance skin sensor of a type well known in the pertinent art. If used, such a sensor will allow the user to ascertain whether the system has been properly positioned for an injection. In detail, a metal foil is positioned at the extreme distal end of the injector to establish a capacitance signal whenever the foil is in contact with a skin surface of the patient. The function of this signal is actually two-fold. First, it can be used to prevent initial operation, if the system is not properly positioned. And, second, it can be used to interrupt operation of the system, if it becomes improperly positioned during an injection.


Further disclosed herein is a system for injecting a medicament into a patient. The system comprises an injector and a medicament cassette. The medicament cassette comprises a housing, a sleeve movable in the housing between first and second positions, and a syringe comprising a chamber for containing a medicament and an injection needle extending from the syringe chamber. The syringe chamber is at least partially disposed in the sleeve and the injection needle has a skin penetrating end opposite the syringe chamber. The skin penetrating end is disposed within the housing when the sleeve is in the first position and the skin penetrating end extends out from the housing when the sleeve is in the second position. The injector comprises a surface for removably mounting the cassette thereon, and a motor driven link having a first end engageable with a portion of the sleeve when the cassette is mounted on the surface. The link is provided for moving the sleeve from the first position to the second position.


Still further disclosed herein is a system for injecting a medicament. The system comprises an injector and a medicament cassette comprising a syringe for containing a medicament. The injector comprises a plunge rod for expelling the fluid medicament from the syringe, a motor for driving the plunge rod, and a switch operatively coupled to the motor, for allowing a user to set the motor to one of a plurality of different speeds. The plurality of different speeds correspond to a plurality of different injection rates of the system.


Also disclosed herein is a medicament cassette for an autoinjector. The medicament cassette comprises a housing, a sleeve movable in the housing between first and second positions, and a syringe comprising a chamber for containing a medicament and an injection needle extending from the syringe chamber. The syringe chamber is at least partially disposed in the sleeve. The injection needle has a skin penetrating end opposite the syringe chamber, the skin penetrating end disposed within the housing when the sleeve is in the first position and the skin penetrating end extending out from the housing when the sleeve is in the second position. A portion of the sleeve engages a drive link of the autoinjector, when the cassette is mounted on or in the autoinjector.


Further disclosed herein is an injector for injecting a medicament into a patient. The injector comprises a surface for removably mounting a cassette thereon, the cassette having disposed therein a sleeve holding a syringe containing the medicament and a motor driven link having a first end engageable with a portion of the cassette when the cassette is mounted on the surface, the link for moving the sleeve from the first position to the second position.


Also disclosed is a system for injecting a medicament into a patient, comprising an injector and a medicament cassette. The medicament cassette comprises a housing and a syringe comprising a chamber for containing a medicament and an injection needle extending from the syringe chamber, the injection needle having a skin penetrating end opposite the syringe chamber, the skin penetrating end disposed within the housing when the syringe is in a first position and the skin penetrating end extending out from the housing when the syringe is in a second position. The injector comprises a surface for removably mounting the cassette thereon, a motor driven link having a first end engageable with a portion of the syringe when the cassette is mounted on the surface, the link for moving the syringe from the first position to the second position.


Also disclosed is a medicament cassette for an autoinjector, comprising a housing and a syringe. The syringe comprises a chamber for containing a medicament and an injection needle extending from the syringe chamber, the injection needle having a skin penetrating end opposite the syringe chamber, the skin penetrating end disposed within the housing when the syringe is in a first position and the skin penetrating end extending out from the housing when the syringe is in a second position. A portion of the syringe engages a drive link of the autoinjector, when the cassette is mounted on or in the autoinjector.


Further disclosed is a system for injecting a medicament into a patient, comprising an injector and a medicament cassette. The injector comprises a surface for removably mounting the cassette thereon and a motor driven link having a first end for operating the cassette in a needle injection mode.


Further disclosed is a system for injecting a medicament, comprising an injector and a medicament cassette. The injector comprises a plunge rod for expelling a fluid medicament from a syringe, a motor for driving the plunge rod, and a switch operatively coupled to the motor, for allowing a user to select one of a plurality of different medicament injection rates of the system.





BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made in detail to the aspects of the present disclosure, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout.



FIG. 1 is a perspective view of an exemplary embodiment of an autoinjector system for injecting a medicament into a patient.



FIG. 2 is an exploded perspective view of a cassette of the autoinjector system of FIG. 1 with a pre-loaded, pre-filled hypodermic syringe.



FIG. 3A is a sectional view of the pre-loaded cassette, as seen along the line 3-3 of FIG. 1, with the pre-filled hypodermic syringe in a needled concealed (proximal) position.



FIG. 3B is a sectional view of the pre-loaded cassette shown in FIG. 3A with the syringe in a needled extended (distal) position after drug delivery.



FIG. 4 is an exploded perspective view of another embodiment of the cassette.



FIG. 5 is a sectional view of an alternate embodiment of the pre-loaded cassette, as seen along the line 3-3 in FIG. 1.



FIG. 6 is a perspective view of another exemplary embodiment of the autoinjector system showing the cassette engaged with the autoinjector.



FIG. 7 is an exploded perspective view of the cassette of the autoinjector system of FIG. 6 and its component elements.



FIG. 8A is a perspective view of the cassette and a motor/drive system of the autoinjector system of FIG. 6 in position at the beginning and at the end of a duty cycle.



FIG. 8B is a view of the components shown in FIG. 8A with the syringe in the cassette being advanced by a first motor of the motor/drive system for insertion of the syringe needle into a patient.



FIG. 8C is a view of the components shown in FIG. 8B with the plunger in the syringe being advanced by a second motor of the motor/drive system for injection of a fluid medicament from the syringe into the patient.



FIG. 9 is a perspective exploded view of yet another exemplary embodiment of the autoinjector system comprising reusable autoinjector and a corresponding disposable cassette.



FIG. 10A is a perspective top view of an exemplary embodiment of an internal frame of an autoinjector similar to the one shown in FIG. 9 with a delivery motor/drive system attached thereto.



FIG. 10B is a perspective bottom view of the internal frame shown in FIG. 10A with a injection motor/drive system attached thereto.



FIG. 10C is a perspective top view of the internal frame shown in FIG. 10A with autoinjector control components attached thereto.



FIG. 10D is a perspective bottom view of the internal frame shown in FIG. 10A with autoinjector control components attached thereto.



FIG. 11A is an exploded top view of a cassette similar to the one shown in FIG. 9.



FIG. 11B is an exploded side view of a cassette similar to the one shown in FIG. 9.



FIG. 11C is an exploded bottom view of a cassette similar to the one shown in FIG. 9.



FIG. 12 is a perspective view of the an inner sleeve and syringe of a cassette similar to the one shown in FIGS. 9 and 11A-11C.



FIG. 13 is a perspective exploded view of the inner sleeve/syringe shown in FIG. 12 and a housing of the cassette similar to the one shown in FIGS. 9 and 11A-11C.



FIG. 14 is a bottom view of the cassette shown in FIG. 9.



FIG. 15 is table showing injection rates of three different samples of an autoinjector system set at low medium and high delivery motor speed settings for solutions of three different viscosities in centipoise.



FIG. 16 is a perspective exploded view of an alternate embodiment of the cassette that omits the inner sleeve.





DETAILED DESCRIPTION

Referring to FIG. 1, an exemplary embodiment of an autoinjector system for injecting a medicament into a user/patient (a user of the system or another person or animal) is shown and is designated by reference numeral 100. The system 100 generally includes a disposable cassette 112 and a re-usable drive mechanism or autoinjector 114. The autoinjector 114 includes a cradle 116 that is dimensioned to receive and hold the cassette 112 on the autoinjector 114. The autoinjector 114 includes a first (injection) motor 118 (shown in phantom) and a section (delivery) motor 120 (also shown in phantom). The motors 118 and 120 may comprise any suitable, well known type of motor including without limitation, stepper motors and reluctance motors. The motors 118 and 120 each includes a drive system for converting the rotary motion of the motor to linear motion. Such drive systems include without limitation, lead screw/worm gear drive systems, rack and pinion drive systems, and any other linear drive or transmission system which enables the motors 118 and 120 to individually exert axially directed forces on contents of the cassette 112. These forces will need to be directed substantially along the axis 122. Activation of the motors 118 and 120 for the generation of these forces is accomplished by manipulation of a button 124 provided with the autoinjector 114.


Referring to FIG. 2, the cassette 112 comprises a housing 126 having hollow, tubular shaped structure for holding a hypodermic syringe 128 comprising an injection needle 130 that is affixed to the distal end of a fluid chamber 132. A conventional finger grip 134 is provided at the proximal end of the fluid chamber 132. Also, a stopper or plunger 136 is disposed in the proximal end of the fluid chamber 132 to expel fluid medicament from the fluid chamber 132 through the needle 130. A protective cover 138 may be provided to cover the needle 130 when system 100 is not in operational use, and a cap 140 is employed to grip the protective cover 138.


Prior to an operation of the system 100, the cassette 112 is pre-loaded with the syringe 128, which has been pre-filled with an appropriate dose of the desired medicament (e.g., a fluid medicament). Before pre-loading the cassette 112, the protective cover 138 is positioned over the needle 130 on syringe 128. The pre-filled syringe 128 is then inserted into the housing 126 through its proximal end 142. The cap 140 can then be inserted through the distal end 144 of the housing 126 to engage the cap 140 with the protective cover 138.


The cassette 112 (pre-loaded with the pre-filled syringe 128) may be mounted on the autoinjector 114, as shown in FIG. 1, by merely inserting the cassette 112 into the cradle 116 of the autoinjector. When inserted, the opposing protrusions (only protrusion 146a is shown) formed on the housing 126 of the cassette 112 engage with respective recesses 148a and 148b to stabilize the cassette 112 on autoinjector 114.


In one exemplary embodiment, as shown in FIG. 3A, the pre-filled syringe is firmly held inside the cassette 112 with the injection needle 130 of the syringe 128 concealed inside the cassette 112 and thereby hidden from the user/patient's view (a needle concealed position or proximal position) by opposing bumps 150a and 150b formed on inner surfaces of resilient arms 152a and 152b, respectively, of the housing 126 of the cassette 112. The bumps 150a and 150b firmly hold the syringe 128 in a home position (the needle concealed position) until resilient arms 152a and 152b are flexed outwardly by an axial force exerted by the syringe 128, as the drive system of the first motor 118 pushes the syringe 128 through the housing 126 of the cassette 112 to move the injection needle 130 from the needle concealed (proximal) position into a needle extended (distal) position, as shown in FIG. 3B. In this distal position, the syringe 128 is retained in the cassette 112 by stops 153a and 153b provided on inner surfaces of the cassette housing 126, while the injection needle 130 extends from the cassette housing 126 for insertion into a user/patient.


In one exemplary embodiment, the drive system of the first motor 118 engages the syringe 128 in a manner that allows the first motor 118 to retract the syringe 128 and thus the injection needle 130 from the extended (distal) position, thereby returning the injection needle 130 to its concealed (proximal) position with the syringe 128 firmly held in the housing 126 in the home position by the bumps 150a and 150b and the resilient arms 152a and 152b.


In an alternative embodiment, a single motor may be used in place of the first and second motors 118 and 120. The use of the single motor requires an appropriate drive or transmission which is capable of converting the rotary motion of the motor to linear motion and selectively applying the linear motion to the syringe 128 or the stopper 136.



FIG. 4 shows an alternate embodiment of the cassette 112, which includes an inner sleeve 154 and an housing 156. The inner sleeve 154 is a hollow, substantially tube-shaped structure defining a lumen 158. Formed on the outer surface of the inner sleeve 154 is a proximal projection 160 and a distal projection 162 that are axially aligned with each other. The housing 156 defines a lumen 164 and an axially aligned slot 166. Resilient arms 168a and 168b are formed on the housing 156 and are positioned to extend toward the proximal open end of the slot 166. The resilient arms 168a and 168b are respectively formed with detents 170a and 170b and ramps 172a and 172b. The resilient arms 168a and 168b and their corresponding detents 170a and 170b and ramps 172a and 172b define a latch mechanism.


The cassette of FIG. 4 is be pre-loaded with the syringe 128, according to one exemplary embodiment, by inserting the inner sleeve 154 into the lumen 164 of the housing 156 so that the proximal projection 160 on the inner sleeve 154 is positioned and held in the detents 170a and 170b of the resilient arms 168a and 168b, and then inserting the hypodermic syringe 128 into the lumen 158 of the inner sleeve 154. This places the injection needle 130 of the syringe 128 in the concealed (proximal) position within the cassette 112. Subsequently, movement of the syringe 128 through the housing 156, which moves the injection needle 130 from the needle concealed (proximal) position to the needle extended (distal) position is accomplished by the drive system of the first motor 118. In one exemplary embodiment, the drive system of the first motor 18 may include a bar (not shown) that pushes against the proximal projection 160 of the inner sleeve 154, thereby causing the arms 168a and 168b to spread and therefore, release the proximal projection 160 from their grasp. The inner sleeve 154, with syringe 128 firmly held therein, may then be moved in a distal direction through the lumen 164 of the housing 156. This distal movement continues until the distal projection 162 contacts an end abutment 174 of the slot 166. The injection needled 130 of the syringe 128 is now in the needled extended (distal) position. Subsequently, the drive system bar of the first motor 118 may be used to apply a pulling force on the proximal projection to withdraw the inner sleeve 154 in a proximal direction through the lumen 164 of the housing 156. This proximal movement continues until the proximal projection 160 on inner sleeve 154 again engages with the detents 170a and 170b, thereby returning the syringe 128 to the home position and thus placing the injection needle 130 into the corresponding needle concealed (proximal) position.



FIG. 5 shows yet another embodiment of the cassette 112. In this embodiment, an adhesive 176 is disposed on the inner surface of the housing 126 to firmly hold the syringe 128 in the needle concealed (proximal) position. The adhesive 176, or a similar type of restraining element, can be used either directly between the syringe 128 and the housing 126 of the cassette 112, as shown in FIG. 5. The adhesive 176 selectively releases the syringe 128 and then re-adheres to the syringe 28 in response to the push and pull forces exerted on the syringe 128 by the drive system of the first motor 118.


In one exemplary method of operation of the system 100, a pre-loaded cassette 112 is positioned in the cradle 116 of the autoinjector 114, which engages the syringe 128 (FIGS. 3A-3B and FIG. 5) or the proximal projection 160 of the inner sleeve 154 of the cassette 112 (FIG. 4) with the linear drive system of the first motor 118. Prior to an injection, the cap 140 is removed from the cassette 112. Because the cap 140 is attached to the protective cover 138 covering the needle 130 of the syringe 128, the protective cover 138 is also removed. The system 100 is now ready for an injection.


With the system 100 positioned at an injection site (not shown), the button 124 on autoinjector 114 is depressed. Depression of the button 124 causes the linear drive system of the first motor 118 to apply a pushing force to the syringe 128 (FIGS. 3A-3B and FIG. 5) or the proximal projection 160 of the inner sleeve 154 of the cassette 112 (FIG. 4), to move the syringe 128 from the home position where the injection needle 130 is in the needle concealed (proximal) position to an inject position where the injection needled 130 is in the needle extended (distal) position, thereby causing the needle 130 of syringe 128 to penetrate into tissue of the user/patient for an injection. At this time, the linear drive system of the second motor 120 pushes on the stopper 136 of the syringe 128 to expel medicament from the fluid chamber 132 of the syringe 128. After an injection has been completed, the first motor 118 is again activated to apply a pulling force to the syringe 128 (FIGS. 3A-3B and FIG. 5) or the proximal projection 160 of the inner sleeve 154 of the cassette 12 (FIG. 4), to withdraw the syringe 128 from the inject position where the injection needle 130 is in the needle extended (distal) position to the home position, where the injection needle 130 is in the needle concealed (proximal) position. The cassette 112, along with the expended syringe 128, can then be removed from the cradle 116 of the autoinjector 114 and discarded.



FIG. 6 shows another exemplary embodiment of the autoinjector system designated by reference numeral 200. As shown, the system 200 generally includes a disposable cassette 212 and a re-useable autoinjector 214. Further, as shown in phantom in FIG. 6, a motor/drive system 216 and a microcomputer or controller 218 are mounted inside the autoinjector 214. The microcomputer 218 is activated by depressing a button 220 on the autoinjector 214. When activated, the microcomputer 218 controls the operation of the motor/drive system 216 for its interaction with the cassette 212.


As shown in FIG. 7, the cassette 212 includes a housing 222, a inner sleeve 224 and a hypodermic syringe 226 including a fluid chamber 228 for holding a medicament, an injection needle 230, and a plunger 232 that is moveable within the fluid chamber 228 to expel medicament from the chamber 228 through the injection needle 230. The syringe 226 is formed with an orifice 234 that allows for contact with the plunger 232. The syringe 226 is fixedly joined with the inner sleeve 224 and this combination (i.e. syringe 226 and inner sleeve 224) is incorporated with the housing 222 to establish the cassette 212.


Still referring to FIG. 7, the inner sleeve 224 includes a projection or protrusion 236. The housing 222 is formed with a fixation member 238 that is dimensioned for engagement with the autoinjector 214 (FIG. 6). The fixation member 238 engages with the autoinjector 214 to position the cassette 212 in an operational alignment with the motor/drive system 216. The cassette 212 may be fixedly held on the autoinjector 214 during an operation duty cycle of the system 200, and selectively removed from the autoinjector 214 after its use.


As shown in FIG. 7, the housing 222 is formed with a latch mechanism 240. The latch mechanism 240 includes a pair of opposed, resilient arms 242a and 242b that are respectively formed with detents 244a and 244b. As shown, the resilient arms 242a and 242b extend toward the proximal end of a slot 246 that extends along the side 248 of the housing 222.


When assembled, the cassette 212 forms and integral unit and is intended for use only so long as there is medicament in the fluid chamber 228 of the syringe and, it is thereafter disposable. Prior to assembly, the fluid chamber 228 of the syringe 226 will be pre-filled with a defined dose of medicament. The pre-filled syringe 226 is then inserted into the inner sleeve 224 where it is fixedly held. Movements of the inner sleeve 224 will thus result in a corresponding movement of the syringe 226. The combination (i.e. syringe 226 and inner sleeve 224) is then joined with the housing 222. When so joined, the protrusion 236 on inner sleeve 224 fits in the detents 244a and 244b between the resilient arms 242a and 242b. Accordingly, the injection needle 230 of the syringe 226 is held inside and concealed in the housing 222 of the cassette 212 in a needle concealed (proximal) position. In this configuration, the cassette 212 may be installed in or onto the autoinjector 214 substantially as shown in FIG. 6.


Referring collectively to FIGS. 8A-8C, one exemplary method of operation of the system 200 will now be described. Although the autoinjector 214 is not shown in FIGS. 8A-8C, the cassette 212 and the motor/drive system 216, shown therein, are to be considered as being operationally positioned within the autoinjector 214 as shown in FIG. 6. The motor/drive system 216 shown in FIG. 8A, includes a first (injection) motor 250 and section (delivery) motor 254. The motors 250 and 254 may comprise any suitable, well known type of motor including without limitation, stepper motors and reluctance motors. The motors 250 and 254 each includes a drive system for converting the rotary motion of the motor to linear motion. Such drive systems include without limitation, lead screw/worm gear drive systems, rack and pinion drive systems, and any other linear drive or transmission system. The drive system associated with the first motor 250 includes a drive rod 252 which is moved by the first motor 250. The drive system associated with the second motor 254 includes a pusher 256 which is moved by the second motor 254. The operations of the first motor 250 and the second motor 254 are both controlled by the microcomputer 218.


In overview, a duty cycle for the system 200 may be envisioned as a series of sequential changes in the configuration of cassette 212. For system 200, these configuration changes are caused by separate operations of the first motor 250 and the second motor 254. In compliance with these operations, a complete duty cycle for the system 200 will constitute, in order, configurations shown from FIG. 8A, to FIG. 8B, to FIG. 8C, and then in reverse order from FIG. 8C, back to FIG. RB and FIG. 8A.



FIG. 8A, shows the cassette 212 with the syringe 226 in a home position, which places the injection needle 230 in the needle concealed (proximal) position. In the home position, the protrusion 236 on inner sleeve 224 is held by the latch mechanism 240 on housing 222. Consequently, the injection needle 230 of the syringe 226 is held and concealed within the cassette 212. FIG. 8B shows the cassette 212 with the syringe 226 moved into an injection position via the first motor 250, which advances the drive rod 252, wherein the injection needle 230 has been extended from the cassette 12 through a hole 258 at the distal end 260 of the autoinjector 214 (FIG. 6). With this advancement, the drive rod 252 interacts with the latch mechanism 240 to release protrusion 236, thereby allowing a distal movement of the now unlatched syringe 226 and inner sleeve 224 on the housing 222. This movement is controlled by the microcomputer 218 and is performed with sufficient force to allow the injection needle 230 to penetrate into the skin tissue of a user/patient. Preferably, this movement of the syringe 226 from the home position (FIG. 8A) to the injection position (FIG. 8B) is accomplished at a speed of about 0.1 m/s to about 1.0 m/s. Further, the first motor 250 may be pre-programmed to stabilize the syringe 226 in the injection position.


With the syringe 226 in the injection position (FIG. 8B), the microcomputer 218 then activates the second motor 254 to move the pusher 256 against the plunger 232 in the fluid chamber 228 (FIG. 7). The microcomputer 218 may be pre-programmed to advance the plunger 232 at an appropriate speed for injection of the medicament, which typically comprises a fluid medicament, from the fluid chamber 228.



FIG. 8C shows the autoinjector assembly 200 after completion of the injection. As mentioned above, completion of the injection duty cycle requires the pusher 256 to be withdrawn. This withdrawal of the pusher 256 is accomplished by the second motor 254. Once the pusher 256 has been withdrawn (FIG. 8B), the first motor 250 is again activated by the microcomputer 218 to withdraw the drive rod 252. The drive rod 252 then pulls the protrusion 236 back and into engagement with the latch mechanism 240, thereby placing the syringe 226 in the home position and the injection needle 230 in the needle concealed (proximal) position. The cassette 212 can then be removed from the autoinjector 214 and discarded.


As an additional feature of the system 200, a sensor 262 may be provided at the distal end of the autoinjector 214. In one exemplary embodiment, the sensor 262 is positioned adjacent the hole 258 of the cassette 212. The sensor 262, in one exemplary embodiment, is of a type that will react to capacitance that can be measured between the sensor 262 and the skin of the user/patient. The sensor 262 determines when the autoinjector 214 is in physical contact with a user/patient's skin. The microcomputer 218 will operate a duty cycle for the system 200 only when such contact is indicated. Otherwise, there can be no operation of the system 200.



FIG. 9 shows yet another exemplary embodiment of the autoinjector system generally designated by reference numeral 300. The system 300 generally includes a disposable cassette 312 and a re-useable autoinjector 314. The autoinjector 314 includes a housing 315 having a cut-out 315a for receiving the cassette 312. The autoinjector housing 315 further includes a recess 315b for receiving a pair of opposing, lateral tabs 312a formed on a proximal end of the cassette 312, when the cassette 312 is positioned in the cut-out 315a of the autoinjector housing 315. The recess 315b of the autoinjector housing 315 and the lateral tabs 330a of the cassette 312 cooperate to securely retain the cassette 312 on the autoinjector 314 and to prevent longitudinal movement of the cassette 312 when the autoinjector 314 is operated. The autoinjector housing 315 also includes an injection button 320 for activating the system 300 and a plurality of indicator lights 321 (e.g., LEDs) for indicating the status of the system 300. A skin sensing sensor 374 is provided at a distal end of the autoinjector 314 for sensing when the distal end of the autoinjector 314 is in physical contact with a user/patient's skin. The autoinjector system 300 will operate only when such contact is indicated. The cassette 312 includes a cap 340 inserted through an aperture (not visible) in a distal end of the cassette 312, which is used for gripping a protective needle shield that covers an injection needle of a syringe contained within the cassette 312, as will be explained in greater detail further on.


Referring now to FIGS. 10A-10D and initially to FIG. 10A, the autoinjector 314 includes an elongated internal frame 316, which is rigidly secured within the autoinjector housing 315 (FIG. 9). The frame 316 includes a cassette support section 316a and motor/drive system and controller (MDC) support section 316b. The cassette support section 316a forms the bottom of the housing cut-out 315a and defines a mounting surface for the cassette 312 (FIG. 9). A motor/drive system 349 is rigidly mounted to MDC support section 316b of the internal frame 316. The motor/drive system 349 includes a first (injection) motor 350 (FIG. 10B) and a second (delivery) motor 354 (FIG. 10A). The first and second motors 350, 354 may comprise any suitable well-known type of motor including, without limitation, stepper motors and reluctance motors. Each of the first and second motors 350, 354 is associated with a drive system for converting the rotary motion of the motor to linear motion. Such drive systems include, without limitation, lead screw/worm gear drive systems, rack and pinion drive systems, and any other linear drive or transmission system that is capable of converting rotary motor motion into linear motion. As shown in FIG. 10B, the first motor 350 is associated with a rack and pinion drive system 352 including a rack member 352a and a pinion 353b, and as shown in FIG. 10A, the drive system associated with the second motor 354 comprises a lead screw drive system 356 comprising a gear drive 356a and lead screw 356b.


Referring again to FIG. 10B, the distal end of the rack member 352b of the rack and pinion drive system 352 forms a drive link 352c. As shown in FIG. 9, the drive link 352c has a free end 352d that extends up through a longitudinally extending, elongated opening 316b in the cassette support section 316a to operate a syringe insertion mechanism of the cassette 312. When the first motor 350 is operated, the rack and pinion drive system 352 moves the drive link 352c in a linear manner such that the free end 352d thereof moves distally and proximally in the longitudinal opening 316b of the cassette support section 316a. A first position sensor 353 is provided for sensing the position and speed of the drive link 352c, as will be explained further on.


Referring again to FIG. 10A, the lead screw 356b of the lead screw drive system 356 drives an elongated pusher 356c. The elongated pusher 356c has a free end 356d which operates a medicament delivery mechanism of the cassette 312. When the second motor 354 is operated, the lead screw drive system 356 moves the pusher 356a in a linear manner such that free end 356d thereof moves longitudinally within the autoinjector 314 in a distal or a proximal direction. A second position sensor 355 is provided for sensing the position and speed of the pusher 356a, as will be explained further on.


Referring now to FIG. 10C, the MDC support section 316b of the internal frame 316 also supports certain control components of the autoinjector 314. These control components include a printed circuit board assembly 318 which defines a microcomputer or controller 319. The printed circuit board assembly 318 includes the injection button 320 and the indicator lights 321 described earlier, and an audible indicator in the form of a piezo-buzzer 322. The controller 319 executes one or more pre-determined programs that control the operation of the first and second motors 350 and 354. A power supply 323 for powering the first and second motors 350 and 354, and all the control components of the autoinjector 314, is also supported by the MDC support section 316b of the internal frame 316. In one exemplary embodiment, the power supply 323 comprises, without limitation, a control circuit, such as a step-up DC to DC convertor, and a battery, such as a rechargeable lithium battery.


As shown in FIG. 10D, the cassette support section 316a of the internal frame also supports certain control components of the autoinjector 314. These control components include a cassette detection switch 370, a speed selection switch 372, and the earlier described skin sensor 374. The power supply 323 also supports the power requirements of these control components. A flexible interconnect 371 is provided for connecting the cassette detection switch 370, the speed selection switch 372, and the skin sensor 374 with the printed circuit board assembly 318.


As shown in FIG. 9, the cassette detection switch 370 is actuated, in one exemplary embodiment, by an actuator button 370a that extends through an aperture in the cassette support section 316a and engages the cassette 312 when same is mounted on the cassette support section 316a. The speed selection switch 372 may be actuated by a button or like actuator 372a extending through another aperture in the cassette support section 316a. A distal end 374a of the skin sensor 374 forms a distal end of the autoinjector housing 315 so that it can make contact with a user/patient's skin.


Referring collectively to FIGS. 11A-11C, the cassette 312 includes a housing 330, an inner sleeve 331 slidably moveable in the housing 330, a hypodermic syringe 326 fixedly disposed in the inner sleeve 331, and the earlier described cap 340. The syringe 326 includes a fluid chamber 326a pre-filled with a predetermined dose of a fluid medicament of a predetermined viscosity, an injection needle 326b (shown with broken lines) extending from a distal end of the fluid chamber 326a, a removable needle shield 326c covering the injection needle 326b, and a plunger 326d moveable within the fluid chamber 326a for expelling medicament from the chamber 326a through the injection needle 326b. The viscosity of the fluid medicament typically ranges between about 1 centipoise to about 320 centipoise, although syringes with fluid medicaments having viscosities greater than 320 centipoise may also be used by appropriate selection of the second motor 354 and/or drive system 356.


As shown in FIG. 12, the inner sleeve 331 includes a pair of locking detents 331a formed on a proximal end of the inner sleeve 331. The locking detents 331a are configured for engaging a finger flange 326e formed on the proximal end of the fluid chamber 326a of the syringe 326, to fixedly retain the syringe 326 in the inner sleeve 331.


As collectively shown in FIGS. 13 and 14, one of the locking detents 331a of the inner sleeve 331 includes a projection or protrusion 331b which engages a latch mechanism 360 formed on the cassette housing 330. The latch mechanism 360 includes a pair of opposed, resilient locking arms 360a that extend proximally from the proximal end of a longitudinally elongated slot 361 formed in a side of the housing 330. The locking arms 360a define locking detent slots 360b through which the protrusion 331b extends.


The cassette 312 is assembled, in one exemplary embodiment, by first inserting the pre-filled syringe 326 into the inner sleeve 331 so that the finger flanges 326e of the fluid chamber 326a are lockingly engaged by the locking detents 331a. The inner sleeve 331 with the pre-filled syringe 326, is then inserted into the housing 330 of the cassette 312 so that the protrusion 331b of the inner sleeve 331 spreads apart- and slides between the locking arms 360a of the housing 330 and then enters the detents slots 360b of the locking arms 360a, where it is latched. Once assembled, the syringe 326 is now in a home position with the injection needle 336b of the syringe 326 concealed in the housing 330 of the cassette 312 in a needle concealed (proximal) position. In an alternate embodiment, the cassette 312 is assembled by first inserting an empty inner sleeve 331 into the housing 330 of the cassette 312 and then inserting the pre-filled syringe 326 into the empty inner sleeve 331.


The first position sensor 353 is provided for sensing the position and speed of the drive link 352c. The position information provided by the first position sensor 353 may be used, in one exemplary embodiment, for identifying when the syringe 326 is in the home position and for determining when the syringe 326 is in a brake position, i.e., a position within the cassette just prior to the needled extended (distal) position. The syringe typically enters the brake position just after the injection needle 326b has penetrated the user/patient's skin. The brake position information allows the controller 319 to stop the first motor 350 quickly and in a manner that minimizes shock and vibration, when the inner sleeve 331/syringe 326 hit an end stop which defines the injection position. The speed information provided by the first position sensor 353 may be used for maintaining the speed of the syringe moving from the home position to the injection position.


The speed selection switch 372 has two or more settings, each of which corresponds to a different, user/patient selectable medicament injection speed (measured in seconds). This allows selection of a medicament injection speed that is most comfortable for the user/patient. In one exemplary embodiment, when the user/patient selects one of the two or more medicament injection speeds using the actuator 372a of the speed selection switch 372, the user/patient is actually setting the voltage applied to the second motor 354 to one of two or more different voltages. The actual medicament injection speed or speed of delivery, however, depends on the load force experienced by the second motor 354 (i.e., the load force applied to the plunger 326d by the pusher 356c). The load force, in turn, depends on the gauge and/or length of the injection needle, medicament viscosity, plunger/fluid chamber friction, motor and drive system tolerances, and cassette tolerances, and other system factors. When the load force experienced by the second motor 354 increases, the speed of the second motor 354 will decrease at the fixed voltage setting thereby decreasing the delivery time/rate of the autoinjector system 300. Similarly, when the load force experienced by the second motor 354 decreases, the speed of the second motor 354 will increase at the fixed voltage setting, thereby increasing the delivery time/rate of the autoinjector system 300. Therefore, in one exemplary embodiment, the controller 319 of the autoinjector 314 is pre-programmed with a feedback control program that compensates for the load force variations experienced by the second motor 354, thereby maintaining the medicament injection speed of the second motor 354. Accordingly, the autoinjector system 300 is capable of providing consistent delivery times/rates for each speed setting of the second motor 354. In one exemplary embodiment, the feedback control program executed by the controller 319 maintains the speed setting of the second motor 354 by measuring the speed of the pusher 356a via the position sensor 355 and then, increasing or decreasing the voltage of the second motor 354 in real-time to maintain a constant pusher speed and therefore provide a constant delivery time/rate for the selected speed setting.


The following discussion describes one exemplary method for operating the autoinjector system 300. First, the user/patient sets the actuator of 372a the speed switch 372 to desired speed setting. The speed switch 372 allows the user/patient to set the second motor 354 to one of a plurality of different medicament injection rates (in seconds) of the autoinjector system 300. FIG. 15 is a table showing injection rates (in seconds) of three different samples (CM2-1, CM2-2, CM2-3) of the autoinjector system 300 set at low, medium, and high delivery motor speed settings for solutions of three different viscosities in centipoise (cP) (1 cP, 19 cP and 29 cP). In one exemplary embodiment, the second motor 354 and drive system 356 are selected to exert up to about 34 pounds of force on the plunger 326d of the syringe 326 (which equates to about 700 psi inside of the fluid chamber 326a of the syringe 326). In other embodiments, the second motor 354 and drive system 356 may be selected to exert more than 34 pounds of force on the plunger 326d of the syringe 326.


Next, the cassette 312 is mounted onto the autoinjector 314 by placing the cassette 312 into the cut-out of the autoinjector housing 315 so that the cassette 312 rests on the cassette support member 316a with the lateral tabs 330a of the cassette housing 330 disposed in the recess 315b of the autoinjector housing 315, (FIG. 9). When so mounted, the cassette 312 depresses the actuator 372a of the cassette detection switch 372 and the protrusion 331b of the cassette inner sleeve 331 engages the free end 352d of the drive link 352c. With the cassette detection switch actuator 372a depressed, the controller 319 will cause audible indicator 322 to sound and the indicator lights 312 to blink in a manner which indicates that the system is ready for use. The user/patient then removes the cap 340 from the cassette 312, thereby removing the needle shield from the syringe 326 and withdrawing it from inside the cassette 312. Next, the user/patient places the distal end of the autoinjector 315 against the user/patient's skin. If the skin sensor senses the user/patient's skin, the controller 319 will cause the indicator lights to light steadily, indicating to the user/patient that the autoinjector system 300 is ready to inject. The user/patient starts the injection by pressing the injection button 320 which energizes the first motor 350 in a first rotary direction, which advances the drive link 352c in the distal direction thereby unlatching the protrusion 331b of the inner sleeve 331 from the latch mechanism 360, thereby allowing a distal movement of the now unlatched inner sleeve 331 containing the syringe 326, relative to the cassette housing 330. The drive link 352c, therefore, moves the syringe 326 from the home position, where the needle 326b is in the needle concealed (proximal) position to the injection position, where the needle 326b is in a needle extended (distal) position and penetrating into the skin tissue of the user/patient. The first motor 350 and drive system 352 are both selected to provide a syringe injection speed, (the speed of the syringe moving from the home position to the injection position) of about 0.01 m/s to about 5.0 m/s, although other syringe injection speeds are possible by selection of an appropriate motor and/or drive system. In other embodiments, the syringe injection speed ranges between about 0.1 m/s to about 1.0 m/s. In some embodiments, a second speed position switch (not shown) may be provided for allowing the user/patient to select between two or more syringe injection speeds, to make the needle injection more comfortable.


With the syringe 326 now in the injection position, the controller 319 energizes the second motor 354 in a first rotary direction, which advances the pusher 356c in the distal direction against the plunger 326d in the fluid chamber 326a of the syringe 326 to inject the fluid medicament from the fluid chamber 326a of the syringe 326. In one embodiment, the controller 310 pauses the autoinjector 314 after completion of the fluid medicament injection to allow pressure to dissipate in the syringe 326 so that all the medicament is delivered and no “dribbling” of medicament occurs. Upon completion of the fluid medicament injection, the controller 319 energizes the second motor 354 in a second rotary direction, which pulls the pusher 356c in the proximal direction, thereby partially withdrawing the pusher 356c from the fluid chamber 326a of the syringe 326 to allow the injection needle to be withdrawn from the user/patient. Once the pusher 356 has been partially withdrawn, the controller 319 energizes the first motor 350 in a second rotary direction, which pulls the drive link 352c back in the proximal direction. Because the free end of the drive link 352c is coupled to the protrusion 331b of the inner sleeve 331, the drive link 352c pulls the inner sleeve 331 containing the spent syringe 326 back to the home position where the protrusion 331b is again latched by the latch mechanism 340, thereby placing the injection needle 330 in the needle concealed (proximal) position again. The controller 319 then energizes the second motor 354 again in the second rotary direction to fully withdraw the pusher 356c from the fluid chamber 326a of the syringe 326. The cassette 312 can now be removed from the autoinjector 314 and discarded.


The autoinjector system 300 may be suitably adapted to provide any desired medicament injection rate. In one exemplary embodiment of the autoinjector system, the medicament injection rates range between about 2.0 seconds and about 15.0 seconds.


In one exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity of about 1 centipoise and the medicament injection rates range between about 2.9 seconds and about 5.0 seconds.


In another exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity of about 19 centipoise and the medicament injection rates range between about 4.4 seconds and about 9.6 seconds.


In a further exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity of about 29 centipoise and the medicament injection rates range between about 7.5 seconds and about 11.8 seconds.


In one exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity of about 19 centipoise.


In another exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 1 centipoise and about 320 centipoise.


In still another exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 5 centipoise and about 40 centipoise.


In yet another exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 10 centipoise and about 35 centipoise.


In a further exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 15 centipoise and about 30 centipoise.


In still a further exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 20 centipoise and about 25 centipoise.


In still a further exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 16 centipoise and about 42 centipoise.


In yet a further exemplary embodiment of the autoinjector system, the medicament comprises a fluid medicament having a viscosity ranging between about 1 centipoise and about 29 centipoise.



FIG. 16 shows an alternate embodiment of the cassette designated by reference numeral 326′. The inner sleeve shown in the embodiment of FIGS. 11A-11C and 12-14 has been omitted and the fluid chamber 326a′ of the syringe 326′ has been provided with a projection or protrusion 326p that engages the latch mechanism 360 formed on the cassette housing 330. The free end 352d of the drive link 352c of the autoinjector 314 (FIG. 9) engages the protrusion 326p to move the syringe 326′ from the home position to the injection position.


Although the autoinjector system and its elements have been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the autoinjector system and its elements, which may be made by those skilled in the art without departing from the scope and range of equivalents of the system and its elements.

Claims
  • 1. An injector for injecting a medicament into a patient, the injector comprising: a surface configured to removably mount a cassette thereon, the cassette having a syringe containing the medicament movably disposed therein;a housing;a frame disposed with the housing, the frame including a cassette support portion providing the surface;a motor driven link having a first end engageable with a portion of the cassette when the cassette is mounted on the surface, the link for moving the syringe from a first position to a second position;a rack and pinion drive system,wherein the rack and pinion drive system includes a rack member, the rack member having a distal end forming the link, andwherein the link comprises a tab extending through an opening in the cassette support portion to engage the cassette.
  • 2. The injector according to claim 1, further comprising a motor driven plunge rod for expelling the medicament contained in the syringe at a specified medicament delivery rate.
  • 3. The injector according to claim 2, further comprising a motor for driving the plunge rod, the motor being speed adjustable to allow a user to select the medicament delivery rate.
  • 4. The injector according to claim 3, further comprising a controller for automatically maintaining the selected medicament delivery rate.
  • 5. The injector according to claim 2, further comprising a second motor for driving the link.
  • 6. The injector according to claim 1, further comprising a motor for driving the link.
  • 7. The injector according to claim 1, further comprising: an injection motor operable coupled to the rack and pinion drive system; anda delivery motor.
  • 8. The injector according to claim 7, further comprising a lead screw drive system coupled to the delivery motor.
  • 9. The injector according to claim 7, wherein the frame further includes a drive support portion, the injection motor and the delivery motor being mounted to the drive support portion.
  • 10. The injector according to claim 7, further comprising a controller configured to execute programs that control the operation of the injection motor and the delivery motor.
  • 11. The injector according to claim 10, further comprising a speed selection switch, the controller configured to control operation of the delivery motor according to a selected medicament delivery rate from the speed selection switch.
  • 12. The injector according to claim 10, further comprising a skin sensor accessible on an exterior of the housing, the skin sensor configured to indicate to the controller when the skin sensor is in physical contact with a patient's skin.
  • 13. The injector according to claim 12, further comprising indicator lights, the controller configured to illuminate the indicator lights in response to the skin sensor indicating physical contact with the patient's skin to indicate that the injector is ready to inject.
  • 14. The injector according to claim 10, further comprising an injection button for activating the injector.
  • 15. The injector according to claim 1, further comprising a cassette detection switch.
  • 16. The injector according to claim 15, wherein the cassette detection switch includes an actuator disposed adjacent to the cassette support portion, the actuator configured to be actuated by a cassette mounted on the cassette support portion.
RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 15/952,296, filed on Apr. 13, 2018, which is a divisional of U.S. application Ser. No. 12/993,163, filed on May 27, 2011, which is the US National phase of PCT/US09/44693, filed May 20, 2009, and claims the benefit of priority as a continuation-in-part of U.S. application Ser. No. 12/123,888, filed May 20, 2008 and as a continuation-in-part of U.S. application Ser. No. 12/178,447, filed Jul. 23, 2008, the entire contents of each of these applications are incorporated herein by reference.

US Referenced Citations (486)
Number Name Date Kind
2525398 Collins Oct 1950 A
2565081 Maynes Aug 1951 A
2701566 Krug Feb 1955 A
2702547 Glass Feb 1955 A
3051173 Johnson et al. Aug 1962 A
3064650 Lewis Nov 1962 A
3203269 Perrine Aug 1965 A
3212685 James et al. Oct 1965 A
3297210 Lucas Jan 1967 A
3623474 Heilman et al. Nov 1971 A
3720211 Kyrias Mar 1973 A
3859996 Mizzy et al. Jan 1975 A
3964481 Gourlandt et al. Jun 1976 A
4108177 Pistor Aug 1978 A
4198975 Haller Apr 1980 A
4231368 Becker Nov 1980 A
4273122 Whitney et al. Jun 1981 A
4276879 Yiournas Jul 1981 A
4333459 Becker Jun 1982 A
4373526 Kling Feb 1983 A
4421107 Estes et al. Dec 1983 A
4465478 Sabelman et al. Aug 1984 A
4493704 Beard et al. Jan 1985 A
4502488 Degironimo et al. Mar 1985 A
4504263 Steuer et al. Mar 1985 A
4515590 Daniel May 1985 A
4573975 Frist et al. Mar 1986 A
4585439 Michel Apr 1986 A
4613328 Boyd Sep 1986 A
4617016 Blomberg Oct 1986 A
4636201 Ambrose et al. Jan 1987 A
4685903 Cable et al. Aug 1987 A
4758227 Lancaster et al. Jul 1988 A
4787893 Villette Nov 1988 A
4790823 Charton et al. Dec 1988 A
4838857 Strowe et al. Jun 1989 A
4877034 Atkins et al. Oct 1989 A
4902279 Schmidtz et al. Feb 1990 A
4919596 Slate et al. Apr 1990 A
4986818 Imbert et al. Jan 1991 A
5013299 Clark May 1991 A
5024616 Ogle, II Jun 1991 A
5034003 Denance Jul 1991 A
5080104 Marks et al. Jan 1992 A
5085641 Sarnoff et al. Feb 1992 A
5092843 Monroe et al. Mar 1992 A
5098400 Crouse et al. Mar 1992 A
5112317 Michel May 1992 A
5114404 Paxton et al. May 1992 A
5114406 Gabriel et al. May 1992 A
5176643 Kramer et al. Jan 1993 A
5180371 Spinello Jan 1993 A
D334233 Schaechter Mar 1993 S
5200604 Rudko et al. Apr 1993 A
5221268 Barton et al. Jun 1993 A
5271413 Dalamagas et al. Dec 1993 A
5300029 Denance Apr 1994 A
5318522 D Antonio Jun 1994 A
5352196 Haber et al. Oct 1994 A
5354286 Mesa et al. Oct 1994 A
5354287 Wacks Oct 1994 A
5382785 Rink Jan 1995 A
5393497 Haber et al. Feb 1995 A
5425715 Dalling et al. Jun 1995 A
5431627 Pastrone et al. Jul 1995 A
5451210 Kramer et al. Sep 1995 A
5456670 Neer et al. Oct 1995 A
5458263 Ciammitti et al. Oct 1995 A
5478316 Bitdinger et al. Dec 1995 A
5540664 Wyrick Jul 1996 A
5569190 D Antonio Oct 1996 A
5569197 Helmus et al. Oct 1996 A
5569212 Brown Oct 1996 A
5578014 Erez et al. Nov 1996 A
5584815 Pawelka et al. Dec 1996 A
5593390 Castellano et al. Jan 1997 A
5599302 Lilley et al. Feb 1997 A
5616132 Newman Apr 1997 A
5647851 Pokras Jul 1997 A
5647853 Feldmann et al. Jul 1997 A
5665071 Wyrick Sep 1997 A
5681291 Galli Oct 1997 A
5690618 Smith et al. Nov 1997 A
5695472 Wyrick Dec 1997 A
5698189 Rowe et al. Dec 1997 A
5709662 Olive et al. Jan 1998 A
5720729 Kriesel Feb 1998 A
5728074 Castellano et al. Mar 1998 A
5746714 Salo et al. May 1998 A
5779675 Reilly et al. Jul 1998 A
5779683 Meyer Jul 1998 A
5807346 Frezza Sep 1998 A
5843036 Olive et al. Dec 1998 A
5868711 Kramer et al. Feb 1999 A
5911703 Slate et al. Jun 1999 A
5919159 Lilley et al. Jul 1999 A
5921963 Erez et al. Jul 1999 A
5921966 Bendek et al. Jul 1999 A
5928158 Aristides Jul 1999 A
5945046 Hehl et al. Aug 1999 A
5957897 Jeffrey Sep 1999 A
5968063 Chu et al. Oct 1999 A
5993412 Deily Nov 1999 A
5993423 Choi Nov 1999 A
6019745 Gray Feb 2000 A
6019747 McPhee Feb 2000 A
6051896 Shibuya et al. Apr 2000 A
6090082 King et al. Jul 2000 A
6099503 Stradella Aug 2000 A
6104941 Huey et al. Aug 2000 A
6149626 Bachynsky et al. Nov 2000 A
6159184 Perez et al. Dec 2000 A
6171276 Lippe et al. Jan 2001 B1
6171283 Perez et al. Jan 2001 B1
6183442 Athanasiou et al. Feb 2001 B1
6190361 Gettig et al. Feb 2001 B1
6203530 Stewart, Sr. Mar 2001 B1
6210369 Wilmot et al. Apr 2001 B1
6213987 Hirsch et al. Apr 2001 B1
6241709 Bechtold et al. Jun 2001 B1
6245043 Villette Jun 2001 B1
6248093 Moberg Jun 2001 B1
6270479 Bergens et al. Aug 2001 B1
6270481 Mason et al. Aug 2001 B1
6280421 Kirchhofer et al. Aug 2001 B1
6290683 Erez et al. Sep 2001 B1
6318647 Gaw Nov 2001 B1
6344030 Duchon et al. Feb 2002 B1
6344032 Perez et al. Feb 2002 B1
6371939 Bergens et al. Apr 2002 B2
6387078 Gillespie, III May 2002 B1
6406456 Slate et al. Jun 2002 B1
6447482 Roenborg et al. Sep 2002 B1
6454743 Weber Sep 2002 B1
6503454 Hadimioglu et al. Jan 2003 B1
6520928 Junior Feb 2003 B1
6540672 Simonsen et al. Apr 2003 B1
6544234 Gabriel Apr 2003 B1
6547755 Lippe et al. Apr 2003 B1
6562006 Hjertman et al. May 2003 B1
6569123 Alchas et al. May 2003 B2
6569127 Fago et al. May 2003 B1
6599272 Hjertman et al. Jul 2003 B1
6641561 Hill et al. Nov 2003 B1
6645169 Slate et al. Nov 2003 B1
6645177 Shearn Nov 2003 B1
6648858 Asbaghi Nov 2003 B2
6652483 Slate et al. Nov 2003 B2
D483116 Castellano Dec 2003 S
6656163 Marshall et al. Dec 2003 B1
6656164 Smith Dec 2003 B1
6669664 Slate et al. Dec 2003 B2
6692469 Weekes et al. Feb 2004 B1
6743202 Hirschman et al. Jun 2004 B2
6746427 Duchon et al. Jun 2004 B2
6752787 Causey et al. Jun 2004 B1
6767336 Kaplan Jul 2004 B1
6770052 Hill et al. Aug 2004 B2
6796957 Carpenter et al. Sep 2004 B2
6805686 Fathallah et al. Oct 2004 B1
6808507 Roser Oct 2004 B2
6817986 Slate et al. Nov 2004 B2
6835193 Epstein et al. Dec 2004 B2
6854620 Ramey Feb 2005 B2
6890319 Crocker May 2005 B1
6932793 Marshall et al. Aug 2005 B1
6979316 Rubin et al. Dec 2005 B1
6986760 Giambattista et al. Jan 2006 B2
7008399 Larsen et al. Mar 2006 B2
7011649 De et al. Mar 2006 B2
7025774 Freeman et al. Apr 2006 B2
7041085 Perez et al. May 2006 B2
7066909 Peter et al. Jun 2006 B1
7094230 Flaherty et al. Aug 2006 B2
7097637 Triplett et al. Aug 2006 B2
7104400 Kiehne Sep 2006 B2
7118553 Scherer Oct 2006 B2
7226450 Athanasiou et al. Jun 2007 B2
7255684 Zubry Aug 2007 B2
7273469 Chan et al. Sep 2007 B1
7290573 Py et al. Nov 2007 B2
7291132 Deruntz et al. Nov 2007 B2
7297135 Jeffrey Nov 2007 B2
7297136 Wyrick Nov 2007 B2
7357790 Hommann et al. Apr 2008 B2
7361160 Hommann et al. Apr 2008 B2
7370759 Hommann May 2008 B2
7381201 Gilbert et al. Jun 2008 B2
7390319 Friedman Jun 2008 B2
7442185 Amark et al. Oct 2008 B2
7449012 Young et al. Nov 2008 B2
7476217 Martin et al. Jan 2009 B2
7500963 Westbye et al. Mar 2009 B2
7500966 Hommann Mar 2009 B2
7553294 Lazzaro et al. Jun 2009 B2
7597685 Olson Oct 2009 B2
7635348 Raven et al. Dec 2009 B2
7635350 Scherer Dec 2009 B2
7648483 Edwards et al. Jan 2010 B2
7654987 Hommann et al. Feb 2010 B2
7670314 Wall et al. Mar 2010 B2
7686789 Nemoto et al. Mar 2010 B2
7731686 Edwards et al. Jun 2010 B2
D619706 Schon et al. Jul 2010 S
7749195 Hommann Jul 2010 B2
7760099 Knight Jul 2010 B2
7785292 Harrison Aug 2010 B2
D625015 Hansen et al. Oct 2010 S
7828776 Nemoto et al. Nov 2010 B2
D628690 Galbraith Dec 2010 S
7857791 Jacobs et al. Dec 2010 B2
7887513 Nemoto et al. Feb 2011 B2
7901377 Harrison et al. Mar 2011 B1
7909796 Weber Mar 2011 B2
7918823 Edwards et al. Apr 2011 B2
7922695 Wiegel et al. Apr 2011 B2
D637713 Nord et al. May 2011 S
7938803 Mernoe et al. May 2011 B2
D642261 York et al. Jul 2011 S
7976499 Grunhut et al. Jul 2011 B2
8012120 Slate et al. Sep 2011 B2
8012125 Fago et al. Sep 2011 B1
8016797 Gratwohl et al. Sep 2011 B2
8043262 Streit et al. Oct 2011 B2
8048037 Kohlbrenner et al. Nov 2011 B2
8052645 Slate et al. Nov 2011 B2
D650070 Mori Dec 2011 S
8088096 Lauchard et al. Jan 2012 B2
8105271 Matusch Jan 2012 B2
8141417 Gibson et al. Mar 2012 B2
8152779 Cabiri Apr 2012 B2
8177749 Slate et al. May 2012 B2
8221356 Enggaard et al. Jul 2012 B2
8226610 Edwards et al. Jul 2012 B2
8277414 Barrow-Williams et al. Oct 2012 B2
8298171 Ishikawa et al. Oct 2012 B2
8308687 Carrel et al. Nov 2012 B2
8337472 Edginton et al. Dec 2012 B2
D673677 Noda et al. Jan 2013 S
8343103 Moser Jan 2013 B2
8376985 Pongpairochana et al. Feb 2013 B2
D679008 Schroeder et al. Mar 2013 S
D679391 Chinowsky et al. Apr 2013 S
8491538 Kohlbrenner et al. Jul 2013 B2
8523803 Favreau Sep 2013 B1
8591465 Hommann Nov 2013 B2
D694879 Julian et al. Dec 2013 S
8603026 Favreau Dec 2013 B2
8603027 Favreau Dec 2013 B2
8609621 Bedzyk et al. Dec 2013 B2
8628723 Vandergaw Jan 2014 B2
D702343 Dale et al. Apr 2014 S
D702835 Vinchon Apr 2014 S
8690827 Edwards et al. Apr 2014 B2
8696628 Grunhut Apr 2014 B2
8716711 Iwasaki May 2014 B2
D718439 Woehr et al. Nov 2014 S
8900204 Geertsen Dec 2014 B2
8911410 Ekman et al. Dec 2014 B2
8960827 McMillin et al. Feb 2015 B2
8961473 Heald Feb 2015 B2
8968255 Oakland Mar 2015 B2
9011386 Kronestedt et al. Apr 2015 B2
9138542 Smith Sep 2015 B2
D748783 Zhang et al. Feb 2016 S
9278177 Edwards et al. Mar 2016 B2
D757254 Wohlfahrt et al. May 2016 S
D765241 Holland Aug 2016 S
D768851 Rozwadowski et al. Oct 2016 S
D768852 Rozwadowski et al. Oct 2016 S
9616173 Slate et al. Apr 2017 B2
9649443 Klintenstedt et al. May 2017 B2
9925336 Slate et al. Mar 2018 B2
9974904 Burk et al. May 2018 B2
10092703 Mounce et al. Oct 2018 B2
10092706 Denzer et al. Oct 2018 B2
D898908 Denzer et al. Oct 2020 S
20010005781 Bergens et al. Jun 2001 A1
20010011163 Nolan et al. Aug 2001 A1
20010018548 Silverman et al. Aug 2001 A1
20010018937 Nemoto Sep 2001 A1
20010034502 Moberg et al. Oct 2001 A1
20010047153 Trocki et al. Nov 2001 A1
20020016569 Critchlow et al. Feb 2002 A1
20020022066 Matsubayashi et al. Feb 2002 A1
20020029018 Jeffrey Mar 2002 A1
20020045864 Perez et al. Apr 2002 A1
20020095120 Larsen et al. Jul 2002 A1
20020099334 Hanson et al. Jul 2002 A1
20020133113 Madsen et al. Sep 2002 A1
20020133114 Itoh Sep 2002 A1
20020151855 Douglas et al. Oct 2002 A1
20020156426 Gagnieux et al. Oct 2002 A1
20030036725 Lavi et al. Feb 2003 A1
20030050592 Slate et al. Mar 2003 A1
20030065536 Hansen et al. Apr 2003 A1
20030105430 Lavi et al. Jun 2003 A1
20030114798 Langley et al. Jun 2003 A1
20030233070 De La Serna et al. Dec 2003 A1
20030236502 De et al. Dec 2003 A1
20040019326 Gilbert et al. Jan 2004 A1
20040039336 Amark et al. Feb 2004 A1
20040054327 Gillespie Mar 2004 A1
20040068266 Delmotte Apr 2004 A1
20040116861 Trocki et al. Jun 2004 A1
20040129803 Dolder et al. Jul 2004 A1
20040133154 Flaherty et al. Jul 2004 A1
20040133162 Trocki et al. Jul 2004 A1
20040153008 Sharf et al. Aug 2004 A1
20040208845 Michal et al. Oct 2004 A1
20040225262 Fathallah et al. Nov 2004 A1
20040258756 McLoughlin Dec 2004 A1
20050020979 Westbye et al. Jan 2005 A1
20050027255 Lavi et al. Feb 2005 A1
20050033242 Perez et al. Feb 2005 A1
20050049561 Hommann et al. Mar 2005 A1
20050054987 Perez et al. Mar 2005 A1
20050080377 Sadowski et al. Apr 2005 A1
20050148869 Masuda Jul 2005 A1
20050165404 Miller Jul 2005 A1
20050171476 Judson et al. Aug 2005 A1
20050171477 Rubin et al. Aug 2005 A1
20050197650 Sugimoto et al. Sep 2005 A1
20050203466 Hommann et al. Sep 2005 A1
20050209569 Ishikawa et al. Sep 2005 A1
20050261633 Khalaj Nov 2005 A1
20050261693 Miller et al. Nov 2005 A1
20050277885 Scherer Dec 2005 A1
20060022363 Konno et al. Feb 2006 A1
20060030819 Young et al. Feb 2006 A1
20060157064 Davison et al. Jul 2006 A1
20060173408 Wyrick Aug 2006 A1
20060251646 Utku Nov 2006 A1
20060258990 Weber Nov 2006 A1
20060270985 Hommann et al. Nov 2006 A1
20070021720 Guillermo Jan 2007 A1
20070025879 Vandergaw Feb 2007 A1
20070027430 Hommann Feb 2007 A1
20070066938 Iio et al. Mar 2007 A1
20070100281 Morris et al. May 2007 A1
20070112301 Preuthun et al. May 2007 A1
20070112310 Lavi et al. May 2007 A1
20070118081 Daily et al. May 2007 A1
20070135767 Gillespie et al. Jun 2007 A1
20070142787 Scherer Jun 2007 A1
20070149925 Edwards et al. Jun 2007 A1
20070167920 Hommann Jul 2007 A1
20070173770 Stamp Jul 2007 A1
20070197954 Keenan Aug 2007 A1
20070197968 Pongpairochana et al. Aug 2007 A1
20070219498 Malone et al. Sep 2007 A1
20070233001 Burroughs et al. Oct 2007 A1
20070239114 Edwards et al. Oct 2007 A1
20070250010 Hohlfelder et al. Oct 2007 A1
20070265568 Tsals et al. Nov 2007 A1
20080015510 Sandoz et al. Jan 2008 A1
20080039795 Slate et al. Feb 2008 A1
20080051711 Mounce et al. Feb 2008 A1
20080051714 Moberg et al. Feb 2008 A1
20080051715 Young et al. Feb 2008 A1
20080097325 Tanaka et al. Apr 2008 A1
20080132841 Chiwanga et al. Jun 2008 A1
20080140007 Glynn Jun 2008 A1
20080262423 Ingram et al. Oct 2008 A1
20080262434 Vaillancourt Oct 2008 A1
20080312602 Barrow-Williams et al. Dec 2008 A1
20090018494 Nemoto et al. Jan 2009 A1
20090018505 Arguedas et al. Jan 2009 A1
20090024112 Edwards et al. Jan 2009 A1
20090043253 Podaima Feb 2009 A1
20090076383 Toews et al. Mar 2009 A1
20090149744 Nemoto et al. Jun 2009 A1
20090254060 Hetherington Oct 2009 A1
20090270672 Fago Oct 2009 A1
20090281505 Hansen et al. Nov 2009 A1
20090292246 Slate et al. Nov 2009 A1
20090299288 Sie et al. Dec 2009 A1
20090299290 Moberg Dec 2009 A1
20090312705 Grunhut et al. Dec 2009 A1
20090322545 Gibson et al. Dec 2009 A1
20090326459 Shipway et al. Dec 2009 A1
20100016793 Jennings et al. Jan 2010 A1
20100016795 McLoughlin Jan 2010 A1
20100021456 Miossec et al. Jan 2010 A1
20100022955 Slate et al. Jan 2010 A1
20100036318 Raday et al. Feb 2010 A1
20100036320 Cox et al. Feb 2010 A1
20100042054 Elahi et al. Feb 2010 A1
20100112679 Vandergaw May 2010 A1
20100152655 Stamp Jun 2010 A1
20100152659 Streit et al. Jun 2010 A1
20100160894 Julian et al. Jun 2010 A1
20100185152 Larsen et al. Jul 2010 A1
20100198060 Fago et al. Aug 2010 A1
20100268170 Carrel et al. Oct 2010 A1
20100312195 Johansen et al. Dec 2010 A1
20110004165 Lio Jan 2011 A1
20110023281 Schraga Feb 2011 A1
20110044998 Bedian et al. Feb 2011 A1
20110047153 Betz Feb 2011 A1
20110092915 Olson et al. Apr 2011 A1
20110097229 Cauley et al. Apr 2011 A1
20110098655 Jennings et al. Apr 2011 A1
20110137286 Mudd et al. Jun 2011 A1
20110144594 Sund et al. Jun 2011 A1
20110152781 Brunnberg et al. Jun 2011 A1
20110160580 Perkins et al. Jun 2011 A1
20110166512 Both et al. Jul 2011 A1
20110184383 Hasegawa Jul 2011 A1
20110190693 Takatsuka et al. Aug 2011 A1
20110190702 Stumber Aug 2011 A1
20110196339 Hirschel et al. Aug 2011 A1
20110202011 Wozencroft Aug 2011 A1
20110213315 Sweeney et al. Sep 2011 A1
20110224616 Slate et al. Sep 2011 A1
20110224620 Johansen et al. Sep 2011 A1
20110224621 Johansen et al. Sep 2011 A1
20110230833 Landman et al. Sep 2011 A1
20110245761 Jennings et al. Oct 2011 A1
20110257596 Gaudet Oct 2011 A1
20110257604 Banik Oct 2011 A1
20110264046 Nyholm et al. Oct 2011 A1
20110270220 Genosar Nov 2011 A1
20120035472 Bruce et al. Feb 2012 A1
20120035538 Elmen et al. Feb 2012 A1
20120056019 Renz et al. Mar 2012 A1
20120059319 Segal Mar 2012 A1
20120089119 Slate et al. Apr 2012 A1
20120101439 Slate et al. Apr 2012 A9
20120172815 Holmqvist Jul 2012 A1
20120238961 Julian et al. Sep 2012 A1
20120253314 Harish et al. Oct 2012 A1
20120265142 Slate et al. Oct 2012 A1
20120296286 Raab et al. Nov 2012 A1
20120323176 Watanabe et al. Dec 2012 A1
20130018313 Kramer et al. Jan 2013 A1
20130018315 Blomquist Jan 2013 A1
20130030383 Keitel Jan 2013 A1
20130035647 Veasey et al. Feb 2013 A1
20130046248 Raab Feb 2013 A1
20130110049 Cronenberg et al. May 2013 A1
20130110054 Raab et al. May 2013 A1
20130112521 Ekman et al. May 2013 A1
20130131595 Ekman et al. May 2013 A1
20130131601 Pommereau et al. May 2013 A1
20130190719 Smith et al. Jul 2013 A1
20130190721 Kemp et al. Jul 2013 A1
20130204198 Burnell et al. Aug 2013 A1
20130204204 Butler et al. Aug 2013 A1
20130218092 Davies et al. Aug 2013 A1
20130226091 Nzike et al. Aug 2013 A1
20130261558 Hourmand et al. Oct 2013 A1
20130274668 Barrow-Williams et al. Oct 2013 A1
20130281936 Kemp et al. Oct 2013 A1
20130289491 Kramer et al. Oct 2013 A1
20130310744 Brereton et al. Nov 2013 A1
20130310761 Plumptre Nov 2013 A1
20130317430 Brereton et al. Nov 2013 A1
20130317480 Reber et al. Nov 2013 A1
20130324935 Brereton et al. Dec 2013 A1
20130338601 Cowe Dec 2013 A1
20140046259 Reber et al. Feb 2014 A1
20140148784 Anderson et al. May 2014 A1
20140194854 Tsals Jul 2014 A1
20140236087 Alderete et al. Aug 2014 A1
20140257197 Madsen et al. Sep 2014 A1
20140276448 Muller-Pathle et al. Sep 2014 A1
20140296825 Lemaire et al. Oct 2014 A1
20140303556 Travanty Oct 2014 A1
20140316369 Centeno et al. Oct 2014 A1
20140330203 McLoughlin et al. Nov 2014 A1
20140330216 Weaver et al. Nov 2014 A1
20140336590 Hourmand et al. Nov 2014 A1
20140364808 Niklaus et al. Dec 2014 A1
20150045729 Denzer et al. Feb 2015 A1
20150080809 Dasbach et al. Mar 2015 A1
20150136809 Hamann et al. May 2015 A1
20150141923 Wurmbauer et al. May 2015 A1
20150151046 Nagel et al. Jun 2015 A1
20150165130 Butler et al. Jun 2015 A1
20150217057 Hogdahl Aug 2015 A1
20160022914 Mounce et al. Jan 2016 A1
20160120751 Mounce et al. May 2016 A1
20160271326 Slate et al. Sep 2016 A1
20170043105 Elmen Feb 2017 A1
20170157326 Slate et al. Jun 2017 A1
Foreign Referenced Citations (188)
Number Date Country
2009249027 Aug 2014 AU
2074565 Feb 2000 CA
2594627 Aug 2006 CA
102007061775 Jul 2009 DE
0654279 May 1995 EP
1219312 Jul 2002 EP
1227423 Jul 2002 EP
1518575 Mar 2005 EP
1859827 Nov 2007 EP
0620748 Jul 2010 EP
2654832 Oct 2013 EP
2121536 Nov 1998 ES
2390175 Dec 1978 FR
2581548 Nov 1986 FR
2592307 Jul 1987 FR
2622457 May 1989 FR
2716375 Aug 1995 FR
87559 Jun 1993 IL
877559 Jun 1993 IL
63-139563 Jun 1988 JP
02-008157 Jan 1990 JP
07-503384 Apr 1995 JP
07-184938 Jul 1995 JP
07-185000 Jul 1995 JP
11-276583 Oct 1999 JP
2000-237309 Sep 2000 JP
2001-518366 Oct 2001 JP
2002-531228 Sep 2002 JP
2002-543931 Dec 2002 JP
2003-180828 Jul 2003 JP
2003-220142 Aug 2003 JP
2005-131007 May 2005 JP
2005-514082 May 2005 JP
2005-287676 Oct 2005 JP
2005-530565 Oct 2005 JP
2006-507061 Mar 2006 JP
2006-230701 Sep 2006 JP
2006-523507 Oct 2006 JP
2006-528040 Dec 2006 JP
2007-500561 Jan 2007 JP
2007-507260 Mar 2007 JP
2007-111518 May 2007 JP
2007-127086 May 2007 JP
2007-522853 Aug 2007 JP
2007-529243 Oct 2007 JP
2008-508961 Mar 2008 JP
2009-511177 Mar 2009 JP
2010-051828 Mar 2010 JP
2010-511414 Apr 2010 JP
2015-186876 Oct 2015 JP
6038884 Dec 2016 JP
2017-023813 Feb 2017 JP
200833383 Aug 2008 TW
200833387 Aug 2008 TW
200836787 Sep 2008 TW
200840606 Oct 2008 TW
201004667 Feb 2010 TW
201004668 Feb 2010 TW
8606967 Dec 1986 WO
8703494 Jun 1987 WO
8707160 Dec 1987 WO
9118634 Dec 1991 WO
9206725 Apr 1992 WO
9208506 May 1992 WO
9221392 Dec 1992 WO
9302728 Feb 1993 WO
9313817 Jul 1993 WO
9324160 Dec 1993 WO
9325256 Dec 1993 WO
9406494 Mar 1994 WO
9407553 Apr 1994 WO
9521645 Aug 1995 WO
9525555 Sep 1995 WO
9531235 Nov 1995 WO
9534333 Dec 1995 WO
9600594 Jan 1996 WO
9621482 Jul 1996 WO
9626754 Sep 1996 WO
9638190 Dec 1996 WO
9707839 Mar 1997 WO
9731665 Sep 1997 WO
9813077 Apr 1998 WO
9817332 Apr 1998 WO
9821408 May 1998 WO
9828032 Jul 1998 WO
9917823 Apr 1999 WO
9920327 Apr 1999 WO
9921600 May 1999 WO
9965548 Dec 1999 WO
0002605 Jan 2000 WO
0009186 Feb 2000 WO
0024441 May 2000 WO
0025846 May 2000 WO
0100261 Jan 2001 WO
0137903 May 2001 WO
0141835 Jun 2001 WO
0189634 Nov 2001 WO
0207812 Jan 2002 WO
0211792 Feb 2002 WO
0249691 Jun 2002 WO
0260513 Aug 2002 WO
0292153 Nov 2002 WO
0303934 Jan 2003 WO
0306099 Jan 2003 WO
0308023 Jan 2003 WO
0324385 Mar 2003 WO
0339634 May 2003 WO
0347659 Jun 2003 WO
0347663 Jun 2003 WO
0390509 Nov 2003 WO
2003103749 Dec 2003 WO
2004000395 Dec 2003 WO
2004004809 Jan 2004 WO
2004004825 Jan 2004 WO
2004069303 Aug 2004 WO
2004084795 Oct 2004 WO
2004108193 Dec 2004 WO
2005032449 Apr 2005 WO
2005053771 Jun 2005 WO
2005070481 Aug 2005 WO
2005077441 Aug 2005 WO
2005079440 Sep 2005 WO
2005089831 Sep 2005 WO
2005094923 Oct 2005 WO
2006015501 Feb 2006 WO
2006017732 Feb 2006 WO
2006020609 Feb 2006 WO
2006062788 Jun 2006 WO
2006063015 Jun 2006 WO
2006084821 Aug 2006 WO
2006086774 Aug 2006 WO
2007002053 Jan 2007 WO
2007044980 Apr 2007 WO
2007047200 Apr 2007 WO
2007053779 May 2007 WO
2007075677 Jul 2007 WO
2007099044 Sep 2007 WO
2007126851 Nov 2007 WO
2007138299 Dec 2007 WO
2007138313 Dec 2007 WO
2007140610 Dec 2007 WO
2008004670 Jan 2008 WO
2008021776 Feb 2008 WO
2008024810 Feb 2008 WO
2008048750 Apr 2008 WO
2008064092 May 2008 WO
2008075033 Jun 2008 WO
2008083313 Jul 2008 WO
2008093063 Aug 2008 WO
2008094984 Aug 2008 WO
2008095124 Aug 2008 WO
2008107670 Sep 2008 WO
2008113772 Sep 2008 WO
2008139458 Nov 2008 WO
2008139460 Nov 2008 WO
2008146021 Dec 2008 WO
2009006725 Jan 2009 WO
2009019437 Feb 2009 WO
2009097325 Aug 2009 WO
2009125879 Oct 2009 WO
2009143255 Nov 2009 WO
2010023481 Mar 2010 WO
2010026414 Mar 2010 WO
2010076275 Jul 2010 WO
2010089313 Aug 2010 WO
2010091133 Aug 2010 WO
2010099850 Sep 2010 WO
2010100213 Sep 2010 WO
2010127449 Nov 2010 WO
2011014525 Feb 2011 WO
2011056888 May 2011 WO
2011057065 May 2011 WO
2011089206 Jul 2011 WO
2012000871 Jan 2012 WO
2012000940 Jan 2012 WO
2012022771 Feb 2012 WO
2012080481 Jun 2012 WO
2012103140 Aug 2012 WO
2012145685 Oct 2012 WO
2012164389 Dec 2012 WO
2012164394 Dec 2012 WO
2012164397 Dec 2012 WO
2013001378 Jan 2013 WO
2013034984 Mar 2013 WO
2013034986 Mar 2013 WO
2013065055 May 2013 WO
2014143815 Sep 2014 WO
2014144096 Sep 2014 WO
Non-Patent Literature Citations (138)
Entry
Australian Patent Application No. 2009249027, Notice of Acceptance, dated Aug. 7, 2014.
Australian Patent Application No. 2009249027, Office Action, dated Jul. 24, 2013.
Australian Patent Application No. 2012245231, Notice of Allowance, dated Oct. 4, 2016.
Australian Patent Application No. 2012245231, Office Action, dated Jul. 5, 2016.
Australian Patent Application No. 2012245231,Office Action, dated Oct. 19, 2015.
Australian Patent Application No. 2014268139, Office Action, dated Jul. 19, 2016.
Australian Patent Application No. 2014268140, Office Action, dated Jul. 22, 2016.
Australian Patent Application No. 2014268140, Office Action, dated Sep. 2, 2016.
Australian Patent Application No. 2017200125, Office Action, dated Sep. 18, 2017.
Australian Patent Application No. 2017202210, Office Action, dated Oct. 25, 2018.
Australian Patent Application No. 2018253467, Office Action, dated Dec. 6, 2019.
Australian Patent Application No. 2019202863, Office Action, dated Sep. 13, 2019.
Canadian Patent Application No. 2724641, Office Action, dated Dec. 15, 2016.
Canadian Patent Application No. 2724641, Office Action, dated Jun. 4, 2015.
Canadian Patent Application No. 2724641, Office Action, dated May 27, 2019.
Canadian patent application No. 2724641, Office Action, dated Sep. 29, 2017.
Canadian patent application No. 2833748, Office Action, dated Aug. 12, 2016.
Canadian Patent Application No. 2833748, Office Action, dated May 2, 2017.
Canadian Patent Application No. 2833748, Office Action, dated Nov. 23, 2015.
Canadian Patent Application No. 3021845, Office Action, dated Aug. 19, 2019.
Canadian Patent Application No. 3021845, Office Action, dated May 7, 2020.
European Patent Application No. 09751483.0, Extended Search Report, dated Aug. 1, 2013.
European Patent Application No. 09751483.0, Office Action, dated Apr. 10, 2015.
European patent Application No. 09751483.0, Office Action, dated Aug. 1, 2016.
European Patent Application No. 09751483.0, Office Action, dated May 14, 2014.
European Patent Application No. 09751483.0, Office Action, dated Nov. 16, 2015.
European patent application No. 12774589.1, Extended Search Report, dated Feb. 23, 2015.
European Patent Application No. 12774589.1, Extended Search Report, dated Jul. 8, 2015.
European Patent Application No. 12774589.1, Office Action, dated Oct. 31, 2017.
European Patent Application No. 14763010.7, Extended Search Report and Opinion, dated Jan. 10, 2017.
European patent application No. 14763010.7, Partial Supplementary Search Report, dated Oct. 24, 2016.
European Patent Application No. 14765760.5, Extended Search Report, dated Jan. 11, 2017.
European Patent Application No. 14765760.5, Office Action, dated Jul. 9, 2019.
European patent application No. 14765760.5, Partial Supplementary Search Report, dated Oct. 24, 2016.
European Patent Application No. 19154409.7, European Search Report and Search Opinion, dated Oct. 31, 2019.
European Patent Application No. 19191313.6, European Search Report, dated Dec. 16, 2019.
International Patent Application No. PCT/US2009/044693, International Search Report, dated Jul. 21, 2009.
International Patent Application No. PCT/US2009/044693, Written Opinion of the International Searchina Authority, dated May 20, 2009.
International Patent Application No. PCT/US2012/034535, International Search Report and Written Opinion, dated Aug. 17, 2012.
International Patent Application No. PCT/US2014/027950, International Search Report and Written Opinion, dated Oct. 7, 2014.
International Patent Application No. PCT/US2014/028363, International Search Report and Written Opinion, dated Aug. 18, 2014.
International Preliminary Report on Patentability for corresponding International Application No. PCT/US2009/044693, dated Nov. 23, 2010.
International Preliminary Report on Patentability for corresponding International Application No. PCT/US2012/034535, dated Oct. 22, 2013.
International Preliminary Report on Patentability for corresponding International Application No. PCT/US2014/027950, dated Sep. 15, 2015.
International Preliminary Report on Patentability for corresponding International Application No. PCT/US2014/028363, dated Sep. 15, 2015.
Japanese Patent APPiication No. 2015-171851, Office Action, dated Feb. 6, 2017.
Japanese Patent Application No. 2011-510683, Final Office Action, dated Jun. 1, 2015.
Japanese Patent Application No. 2011-510683, Notice of Allowance, dated Oct. 5, 2015.
Japanese Patent Application No. 2011-510683, Office Action, dated Jul. 30, 2013.
Japanese Patent Application No. 2011-510683, Office Action, dated Jun. 30, 2014.
European Application No. 22177279.1, European Search Report and Opinion, dated Sep. 19, 2022.
U.S. Appl. No. 16/832,987, Non-Final Office Action, dated Sep. 29, 2022.
European Patent Application No. 19/154,409, Decision to grant a European patent, dated Jun. 17, 2022.
Japanese Patent Application No. 2020-041954, Office Action, dated Jun. 20, 2022.
U.S. Appl. No. 16/810,414, Notice of Allowance, dated Jul. 14, 2022.
Japanese Patent Application No. 2021-078657, Office Action, dated Jun. 6, 2022.
U.S. Appl. No. 16/810,414, Notice of Allowance, dated Apr. 13, 2022.
CA Patent Application No. 3070644, Examination Report, dated Aug. 16, 2021.
Canadian Patent Application No. 3021845, Office Action, dated Dec. 4, 2020.
Japanese Application No. 2020-041954 Notice of Reasons for Rejection dated Jan. 4, 2021.
Japanese Patent Application No. 2020-041954, Decision of Rejection, dated Aug. 2, 2021.
U.S. Appl. No. 13/269,750, Office Action, dated Nov. 18, 2015.
U.S. Appl. No. 13/454,531, Final Office Action, dated Sep. 23, 2016.
U.S. Appl. No. 13/454,531, Non-Final Office Action, dated Dec. 28, 2012.
U.S. Appl. No. 13/454,531, Notice of Allowance, dated Oct. 5, 2015.
U.S. Appl. No. 13/454,531, Office Action, dated Apr. 21, 2015.
U.S. Appl. No. 13/454,531, Office Action, dated Oct. 7, 2014.
U.S. Appl. No. 14/112,479, Final Office Action, dated Feb. 27, 2017.
U.S. Appl. No. 14/112,479, Non-Final Office Action, dated Jul. 12, 2017.
U.S. Appl. No. 14/112,479, Non-Final Office Action, dated Jul. 29, 2016.
U.S. Appl. No. 15/167,068, Final Office Action, dated Apr. 24, 2019.
U.S. Appl. No. 15/167,068, Non-Final Office Action, dated Feb. 14, 2020.
U.S. Appl. No. 15/167,068, Non-Final Office Action, dated Oct. 18, 2018.
U.S. Appl. No. 15/167,068, Non-Final Office Action, dated Oct. 9, 2019.
U.S. Appl. No. 15/167,068, Notice of Allowance, dated Jul. 2, 2020.
U.S. Appl. No. 15/782,925, Final Office Action, dated Oct. 11, 2019.
U.S. Appl. No. 15/782,925, Non-Final Office Action, dated Oct. 7, 2020.
U.S. Appl. No. 15/782,951, Notice of Allowance, dated May 20, 2020.
U.S. Appl. No. 15/782,951, Notice of Allowance, dated Oct. 11, 2019.
U.S. Appl. No. 15/952,296, Non-Final Office Action, dated Jan. 14, 2020.
U.S. Appl. No. 15/952,296, Notice of Allowance, dated Jun. 1, 2020.
U.S. Appl. No. 16/026,294, Final Office Action, dated Jul. 30, 2020.
U.S. Appl. No. 16/026,294, Non-Final Office Action, dated Mar. 18, 2020.
U.S. Appl. No. 16/026,294, Notice of Allowance, dated Oct. 16, 2020.
Japanese Patent Application No. 2014-021052, Final Office Action, dated Apr. 20, 2015.
Japanese Patent Application No. 2014-021052, Notice of Allowance, dated Aug. 24, 2015.
Japanese Patent Application No. 2014-021052, Office Action, dated Jan. 5, 2015.
Japanese Patent Application No. 2014-506591, Notice of Allowance, dated Oct. 3, 2016.
Japanese Patent Application No. 2014-506591, Office Action, dated Jan. 4, 2016.
Japanese Patent Application No. 2015-186876, Office Action, dated Jul. 15, 2016.
Japanese Patent Application No. 2016-214237, Notice of Reasons for Rejection, dated Sep. 4, 2017.
Japanese Patent Application No. 2016-502669, Notice of Reasons for Rejection, dated Jan. 14, 2020.
Japanese Patent Application No. 2017-089529, Notice of Reasons for Rejection, dated Apr. 2, 2018.
Japanese Patent Application No. 2017-089529, Notice of Reasons for Rejection, dated Sep. 14, 2018.
Japanese Patent Application No. 2018-086731, Decision of Rejection, dated Feb. 3, 2020.
Japanese Patent Application No. 2018-188224, Notice of Reasons for Rejection, dated Aug. 5, 2019.
Japanese Patent Application No. 2018-228060, Notice of Reasons for Rejection, dated Oct. 21, 2019.
Japanese Patent Application No. 2019-070580, Notice of Reasons for Rejection, dated Feb. 25, 2020.
Mexican Patent Application No. MX/a/2010/012691, Office Action, dated Feb. 10, 2014.
Mexican Patent Application No. MX/a/2010/012691, Office Action, dated Sep. 24, 2014.
Taiwan Patent Application No. 103109332, Office Action, dated Aug. 22, 2016.
Taiwan Patent Application No. 103109475, Office Action, dated Aug. 26, 2016.
Taiwan Patent Application No. 106100512, Office Action, dated Dec. 4, 2017.
U.S. Appl. No. 12/123,888, Final Office Action, dated Apr. 8, 2010.
U.S. Appl. No. 12/123,888, Notice of Allowance, dated Jan. 12, 2012.
U.S. Appl. No. 12/123,888, Notice of Allowance, dated Oct. 3, 2011.
U.S. Appl. No. 12/123,888, Office Action, dated Dec. 22, 2010.
U.S. Appl. No. 12/123,888, Office Action, dated Jun. 8, 2011.
U.S. Appl. No. 12/123,888, Office Action, dated Oct. 5, 2009.
U.S. Appl. No. 12/178,447, Final Office Action, dated Mar. 30, 2010.
U.S. Appl. No. 12/178,447, Non-Final Office Action, dated Dec. 22, 2010.
U.S. Appl. No. 12/178,447, Non-Final Office Action, dated Oct. 15, 2009.
U.S. Appl. No. 12/178,447, Notice of Allowance, dated Apr. 6, 2011.
U.S. Appl. No. 12/178,447, Notice of Allowance, dated Jun. 24, 2011.
U.S. Appl. No. 12/454,531, Non-Final Office Action, dated Apr. 21, 2015.
U.S. Appl. No. 12/454,531, Non-Final Office Action, dated Sep. 13, 2013.
U.S. Appl. No. 12/454,531, Office Action, dated Dec. 28, 2012.
U.S. Appl. No. 12/993,163, Final Office Action, dated Feb. 22, 2016.
U.S. Appl. No. 12/993,163, Non-Final Office Action, dated Dec. 27, 2013.
U.S. Appl. No. 12/993,163, Non-Final Office Action, dated Jul. 28, 2016.
U.S. Appl. No. 12/993,163, Non-Final Office Action, dated Sep. 11, 2014.
U.S. Appl. No. 12/993,163, Office Action, dated May 8, 2015.
U.S. Appl. No. 13/269,150, Final Office Action, dated Oct. 18, 2016.
U.S. Appl. No. 13/269,740, Office Action, dated Apr. 2, 2013.
U.S. Appl. No. 13/269,740, Office Action, dated Jun. 21, 2013.
U.S. Appl. No. 13/269,740, Office Action, dated May 20, 2013.
U.S. Appl. No. 13/269,750, Final Office Action, dated Dec. 26, 2013.
U.S. Appl. No. 13/269,750, Final Office Action, dated Oct. 18, 2016.
U.S. Appl. No. 13/269,750, Non-Final Office Action, dated Aug. 21, 2014.
U.S. Appl. No. 13/269,750, Non-Final Office Action, dated Jun. 21, 2013.
U.S. Appl. No. 13/269,750, Non-Final Office Action, dated May 3, 2016.
U.S. Appl. No. 13/269,750, Notice of Allowance, dated Feb. 8, 2017.
U.S. Appl. No. 13/269,750, Office Action, dated Aug. 10, 2015.
U.S. Appl. No. 13/269,750, Office Action, dated Mar. 12, 2015.
Japanese Application No. 2021-078657, Notice of Reasons for Rejection, dated Jan. 16, 2023.
U.S. Appl. No. 16/832,987, Notice of Allowance, dated Apr. 4, 2023.
U.S. Appl. No. 16/832,987, Notice of Allowance, dated Mar. 24, 2023.
U.S. Appl. No. 16/832,987, Requirement for Restriction/Election, dated Apr. 12, 2023.
Related Publications (1)
Number Date Country
20200390976 A1 Dec 2020 US
Divisions (1)
Number Date Country
Parent 12993163 US
Child 15952296 US
Continuations (1)
Number Date Country
Parent 15952296 Apr 2018 US
Child 17003665 US
Continuation in Parts (2)
Number Date Country
Parent 12178447 Jul 2008 US
Child 12993163 US
Parent 12123888 May 2008 US
Child 12178447 US