WO2025117942A1

WO2025117942A1 - Large volume self stable auto injector

Info

Publication number: WO2025117942A1
Application number: PCT/US2024/058066
Authority: WO
Inventors: Jeffery A. LETTMAN; Chris Evans
Original assignee: Noble International LLC
Current assignee: Noble International LLC
Priority date: 2023-11-30
Filing date: 2024-12-02
Publication date: 2025-06-05
Anticipated expiration: 2026-05-30

Abstract

An injection device (100), including: a housing (102); a compressed gas canister (106) configured to contain a compressed gas (108); a flexible package (110) configured to contain a medicament (112); and a needle (114). During a transition to an activated state of the apparatus the apparatus is configured to release the compressed gas and thereby compress the flexible package. At least when the flexible package is being compressed a flow path exists that originates inside the flexible package and that exits the flexible package via the needle.

Description

LARGE VOLUME SELF STABLE AUTO INJECTOR

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and incorporates by reference the contents of U.S. Provisional Application No. 63/604,460, filed November 30, 2023.

FIELD OF THE INVENTION

The invention relates to a self-stable auto injector for administering a relatively large volume of medicament.

BACKGROUND OF THE INVENTION

Proper needle insertion into a patient is an essential component of proper delivery of medicament. The success of these procedures depends on accurate placement and correct technique during insertion of the needle into a target region of a patient. Accuracy of an injection can be hampered by certain factors, including a fear of needles leading to failure to administer an injection, or improper administration of an injection. Lack of knowledge and/or experience in administering injections to oneself or to others may also lead to improper injection administration. In addition, certain conditions such as rheumatoid arthritis (RA) may limit manual dexterity and also lead to improper injection administration.

Moreover, certain conditions require relatively large doses (e.g., 2-7 cc) of medicament. This dosage amount is in contrast to prior art prefilled syringes and auto injectors which are designed to administer relatively small drug volumes (e.g., < 2mL) in under fifteen (15) seconds. Subcutaneous self-delivery of these high-volume doses can significantly improve patients’ quality of life. With the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume medicament is becoming possible. To date, self-administration of these relatively large doses has been met with limited success. Consequently, there is room in the art for improvement. BRIEF DESCRIPTION OF THE DRAWINGS

The invention is explained in the following description in view of the drawings that show:

FIG. 1 A to FIG. 1 B are schematic side views showing internal components of an example embodiment of an auto injector disclosed herein.

FIG. 1 C is a schematic side view of the auto injector of FIG 1 A.

FIG. 1 D is a schematic bottom view of the auto injector of FIG 1 A.

FIG. 1 E is a schematic top view of the auto injector of FIG 1 A.

FIG. 2 is a schematic side view showing internal components of another example embodiment of an auto injector disclosed herein.

FIG. 3A to FIG. 3B are schematic side views showing internal components of another example embodiment of an auto injector disclosed herein.

FIG. 4 is a schematic side view showing internal components of another example embodiment of an auto injector disclosed herein.

FIG. 5A to FIG. 5B are schematic side views showing internal components of another example embodiment of an auto injector disclosed herein.

FIG. 6A to FIG. 6B are schematic views of another example embodiment of an auto injector disclosed herein.

FIG. 7A to FIG. 7D are various schematic views showing external and internal components of another example embodiment of an auto injector disclosed herein.

FIG. 8A to FIG. 8F are various schematic views showing an example embodiment of a workflow associated with the auto injector of FIG. 7A.

FIG. 9A to FIG. 9B are various schematic views showing external and internal components of another example embodiment of an auto injector disclosed herein.

FIG. 10A to FIG. 10C are various schematic views showing an example embodiment of a workflow associated with the auto injector of FIG. 9A.

FIG. 11 A to FIG. 11 B are various schematic views showing external and internal components of another example embodiment of an auto injector disclosed herein.

FIG. 12A to FIG. 12D are various schematic views showing an example embodiment of a workflow associated with the auto injector of FIG. 11 A.

FIG. 13 is a schematic view of another example embodiment of an auto injector disclosed herein. FIG. 14 is a schematic view showing external and internal components of another example embodiment of an auto injector 1400 disclosed herein.

FIG. 15 is a schematic view showing external and internal components of another example embodiment of an auto injector 1500 disclosed herein.

FIG. 16A and FIG. 16B are end views of an example embodiment of an auto injector 1600 disclosed herein.

DETAILED DESCRIPTION OF THE INVENTION

The present inventors have developed a unique and innovative large-volume, low-profile, and stable injection device designed to require minimal effort to maintain in position during extended drug delivery cycles (e.g., >30 seconds) which are associated with high volume injections (e.g., 2-7 cc). When in position to deliver medication, the injection device has a low center of gravity which enables a tipping angle greater than 45 degrees. This makes the injection device far more stable than typical pen style auto injectors which have tipping angles of about three (3) degrees. In embodiments, an injection device may refer to an auto injector or a non auto injector injection device, and in some embodiments may refer to an injection training device which may include a device without a needle, or with out a medicament or without both a needle and a medicament.

This stability is enabled through various features shown in embodiments described herein. A first feature, in one embodiment of the invention described herein includes a primary packaging of the medicament. Unlike glass vials which necessitate a vertical tube arrangement, the primary packaging allows the mass of the medicament to be located low in the auto injector and to be distributed in wide flat packaging in one non-limiting embodiment, both of which help keep the center of gravity of the auto injector low. In some non-limiting embodiments, the primary packaging may include a flexible packaging. A second feature includes a broad, and thereby inherently stabilizing, auto-injector base that is positioned against the injection site and which depresses and flattens the skin prior to the injection. A third feature may include a compressed gas propellant which can be used to exert pressure on the flexible primary packaging to eject the medicament therefrom. In standard auto injectors, a compressed spring assembly needs to be positioned vertically, above the glass vial, to drive the plunger towards the injection site. This arrangement makes the associated pen shaped devices less stable. In at least one embodiment of the proposed device, the compressed gas cylinder may be located close to the base, lowering the center of gravity of the device, and increasing the stability.

The auto injector may be of a design like that of a computer mouse, in a nonlimiting example, to reduce the amount of dexterity required to accurately position and activate the device. After is the device is positioned on the injection site, the auto injector can be activated by pressing the auto injector into the injection site using a finger and/or a proximal portion the palm. Alternatively, the auto injector can be activated by pressing an activation button on the injector, for example. The mouse shape of the injector body orients the palm substantially parallel to the skin at the injection site so that activation of the device requires a simple pressing action, in one embodiment. This simple movement can be beneficial to those with limited mobility, such as patients suffering from rheumatoid arthritis. Once activated, the gas in the pressurized cylinder is released and used to create force that compresses the flexible package and forces the medicament out of the needle, in one example.

In some embodiments, one or more of these features may be included. In one non-limiting embodiment, all three features may be included in the auto injector. The mouse shaped body of the device is a non-limiting example for the design of the body of the device.

FIG. 1 A to FIG. 1 E are various schematic views of an embodiment of an auto injector disclosed 100 herein. The auto injector 100 includes a housing 102 that defines an interior volume 104, a compressed gas canister 106 configured to contain a compressed gas 108; a flexible package 1 10 disposed in the interior volume 104, configured to contain a medicament 1 12, which may be made of a clear material in one non-limiting embodiment, and which may be one of multiple flexible packages or a single flexible package; and a needle 114.

During a transition from an unactivated state to an activated state of the auto injector 100, the auto injector 100 is configured to cause a release of the compressed gas 108 from the compressed gas canister 106 into the interior volume 104. This, in turn, increases pressure in the interior volume 104, which causes an associated compression of the flexible package 110. In this example embodiment, the released compressed gas 108 acts directly on the flexible package 110. The compression creates a flow of the medicament 112 out of the flexible package 110 via the needle 114. In another, non-limiting embodiment, the compressed gas 108 may selectively activate one of multiple flexible packages within the auto injector, either simultaneously, or sequentially.

In this example embodiment, the auto injector 100 further includes a base 120 that is selectively positionable relative to the housing 102. As shown in FIG. 1 A, the base 120 is extended relative to the housing 102. When so extended, the base 120 fully shrouds (extends past) a tip of the needle 114 to protect the needle 114 from unintended contact with, for example, the user. As shown in FIG. 1 B, the base 120 has been pushed into the housing 102 and is thereby retracted relative to the housing 102.

In an example embodiment, pressing the base 120 into the housing 102 causes a transition of the auto injector 100 to an activated state. This may be achieved in any number of ways. For example, a gas activation feature 122 may be associated with the base 120, wherein said gas activation feature 122 may contact the compressed gas canister 106 and thereby release the compressed gas 108 when the base 120 is moved into the retracted position as shown in FIG. 1 B.

Alternately, pressing an activation button 126 that is operatively associated with the compressed gas canister 106 may cause the transition of the auto injector 100 to the activated state. The activation button 126 may be configured to resemble a scroll button, or a left click button, or a right click button on a mouse, or the like, in non-limiting embodiments.

In one embodiment, the auto injector 100 may further include a needle activation assembly 130 that comprises the needle 114 and a needle activator 132. The needle activator 132 is configured to transition the needle 114 from a retracted position shown in FIG. 1 A to an extended position shown in FIG. 1 B during the transition to the activated state. This may be achieved in any number of ways. For example, a needle activation feature 134 may be associated with the base 120 and be caused to contact the needle activator 132 and thereby extend the needle when the base 120 is moved into the retracted position shown in FIG. 1 B. The auto injector 100 may further include a seal 140 between the base 120 to help seal the interior volume 104 to help retain the compressed gas 108 in the interior volume 104 for as long as necessary to complete the dispensing operation.

The housing 102 of the auto injector 100 may further include a viewing window 142 configured to enable viewing of the flexible package 1 10 as the flexible package 110 is compressed. This permits monitoring of how much medicament has been delivered at various times during the dispensing operation, particularly when the flexible package comprises a clear material.

The housing 102 of the auto injector 100 may further include a sound feature 144 such as a whistle that provides an audible whistle noise as the compressed gas 108 in the interior volume 104 escapes through the sound feature 144. A volume and duration of the whistle produced by the sound feature 144 can provide an indication of how much medicament has been delivered at various times during the dispensing operation. The sound feature 144 may include a speaker, in one non-limiting embodiment.

The auto injector 100 may further include a selectively positionable locking switch 146 (travel stop) configured to prevent the base 120 from being moved into the housing 102 when the locking switch 146 is in a locked position shown in FIG. 1A. In this locked position, the locking switch 146 will physically abut a locking stop 148 that is associated with the housing 102. This physical abutment will prevent the base 120 from being pushed into the housing 102. In one embodiment, this will prevent activation of the auto injector 100. When moved to an unlocked position shown in FIG. 1 B, the locking switch 146 will not physically abut the locking stop 148. This will permit the base 120 to be pushed into the housing 102. Alternately, instead of moving the locking switch 146 to the unlocked position, the locking switch 146 may be removable from the auto injector 100 to permit the movement of the base 120, in another embodiment. The locking switch 146 may also act as a sterile barrier over the needle 114 in one example preventing contaminants from contacting the needle 114.

In this example embodiment, the locking switch 146 may also act as a selectively positionable needle guard and is configured to prevent the needle 114 from protruding past the base 120 when the needle guard 146 is in a guarded position as shown in FIG. 1 A protecting a user from an unintentional contact with the needle 114. When in the unguarded position, the needle 114 is free to protrude past the base 120 as is also shown in FIG. 1 B.

The auto injector 100 may further include a peel strip 150 to keep the at least one of the needle 114 sterile (a sterile peel strip) and an adhesive 152 disposed on a bottom 154 of the base 120. The peel strip 150 may be secured to the bottom 154 via the adhesive 152.

The peel strip 150 may also or alternately act as a positive stop (a positive stop peel strip) in addition to or alternate to the locking stop 148. When so configured, the positive stop peel strip 150 may contact the needle 1 14 and this physical abutment will prevent the base 120 from being pushed into the housing 102. Once the positive stop peel strip 150 is removed, the base 120 would be free to be pushed into the housing 102. In such a configuration, the positive stop peel strip 150 may be made of materials not easily punctured by the needle 114 such as a plastic or a metal in a suitable thickness. In this example embodiment, only once the positive stop peel strip 150 is removed is the auto injector 100 ready for injection.

The adhesive 152 shown in FIG. 1 D may be used to gently secure the base 120 to a user’s skin during the dispensing operation.

The auto injector 100 may further include a resilient member 156, shown in FIGS. 1 A-1 B, such as a coil spring, a leaf spring, or a compressible material such as rubber or foam, in non-limiting examples. The resilient member 156 may be used to bias the base 120 away from the housing 102.

FIG. 2 is a schematic side view showing internal components of another example embodiment of an auto injector 200 disclosed herein. In this example embodiment, the auto injector 200 includes a second needle activation assembly 130B that includes a second needle 1 14B and a second needle activator 132B, a second locking switch 146B, and a second locking stop 148B.

The second needle 114B operates similar to the needle 1 14 and is used to create a second flow path of the medicament out of the flexible package 1 10.

The second needle activator 132B operates similar to the needle activator 132, may be operatively associated with the needle activator 132, may be activated when the needle activator 132 is activated, and is used to activate the second needle 114B. The second locking switch 146B and the second locking stop 148B operate similar to the locking switch 146 and the locking stop 148 to selectively prevent the base 120 from being pushed into the housing 102 and to selectively prevent the second needle 114B from protruding past the base 120 when in the guarded position shown in FIG. 2. The second locking switch 146B may be operatively associated with the locking switch 146 and thereby move with the locking switch 146 or be caused to move when the locking switch 146 is moved.

One flexible package 110 is shown, but there could be more than one. For example, there could be one or more separate flexible packages 110 for each needle 114, 114B. The embodiment of the auto injector 200 shown in FIG. 2 may optionally include a resilient member 156 as in the embodiment of the auto injector 100 shown in FIG. 1A-1 B.

The auto injector 200 also includes a communication device 258 in wired or wireless data communication with the activation button 126, with the compressed gas canister 106, with the needle activator 132, with the second needle activator 132B, and with a digital progress indicator 242D. The communication device 258 can communicate wirelessly or via wire with an external device and can provide data to the external device regarding whether the activation button 126, the compressed gas canister 106, the needle activator 132, and/or the second needle activator 132B have been activated.

The communication device 258 is also in wired or wireless data communication with a medicament sensor 204. The medicament sensor 204 may be any sensor capable of determining whether medicament has been dispensed and/or how much medicament has been dispensed. The communication device 258 can also relay that information to the external device.

The auto injector 200 may further include a digital progress indicator 242D. The communication device 258 may provide data from the medicament sensor 204 to the digital progress indicator 242D to digitally indicate the progress of the dispensing operation.

FIG. 3A to FIG. 3B are schematic side views showing internal components of another example embodiment of an auto injector 300 disclosed herein. In this example embodiment, the needle 314 is held in a fixed position that is the same in both the unactivated state shown in FIG. 3A and the activated state in FIG. 3B. The transition from the unactivated state to the activated state occurs simply by pressing the base 120 into the housing 102. This exposes the needle 314 and also brings the gas activation feature 122 into contact with the compressed gas canister 106, which releases the compressed gas 108. This configuration does not have a separate activation switch but could if manual activation via the activation switch is preferred over the gas activation feature 122.

The auto injector 300 further includes a medicament seal 302 disposed inside of the flexible package 1 10 between the medicament 112 and the needle 314. A dry volume 304 exists within the medicament seal 302. The compression caused by the release of the compressed gas 108 upon activation compresses the flexible package 110 and medicament therein. As the medicament 112 is compressed the medicament 112 presses the medicament seal 302 onto the needle 314 until the needle 314 pierces the medicament seal 302. Once the needle 314 pierces the medicament seal 302, the needle 314 is in fluid communication with the medicament 1 12, a flow path is established from an interior 306 of the flexible package 1 10 and through and then out of the needle 314, and the medicament is dispensed.

FIG. 4 is a schematic side view showing internal components of another example embodiment of an auto injector 400 disclosed herein. In this example embodiment, the auto injector 400 includes one or more thermally conductive plates 402 positioned on at least a portion of a bottom surface 404 of the base 420. Due to adiabatic cooling, when the compressed gas 108 is released, it will rapidly cool as it expands to fill the interior volume 104. Selecting a base material which can conduct heat (e.g., aluminum) will take advantage of this cooling effect by providing a numbing effect on the injection site. The thermally conductive plate 402 may have an annular (washer) shape and be disposed to permit the needle 314 to pass through a middle of the annular shape. There may be any number of thermally conductive plates 402 and they may take any shape. The numbing impact on the injection site may serve to dsitract a user from the injection or to decrease sensation experienced during injection or removal of the needle or delivery of medicament therethrough.

In the auto injector 400, the compressed gas canister 106 is configured to cause released compressed gas 108 directly onto the thermally conductive plate 402 so that the released compressed gas impinges the thermally conductive plate 402. This configuration provides maximum cooling of the thermally conductive plate 402. However, the released compressed gas 108 may not be directed onto the thermally conductive plate 402 but instead released generally into the interior volume 104. Alternately, some released compressed gas 108 may be guided directly onto the thermally conductive plate 402 and some may be guided generally into the interior volume 104. In such a combination embodiment, the amount of the released compressed gas 108 that is guided directly onto the thermally conductive plate 402 may be selected to provide an optimum amount of cooling of the thermally conductive plate 402, or to provide selective cooling of the plate over a period of time. In an alternative embodiment, the thermally conductive plate may be heated to provide other beneficial effects to a user prior to, during, or following injection. The heating of the plate may occur by function of use of the device as described herein, or by associating the plate with a heating element prior to use of the auto injector.

FIG. 5A to FIG. 5B are schematic side views showing internal components of another example embodiment of an auto injector 500 disclosed herein. The auto injector 500 includes two base pieces 520A, 520B and a separation apparatus 502. During the transition to the activated state, the separation apparatus 502 spreads the two base pieces 520A, 520B apart, thereby increasing a gap 504 therebetween. This separating action spreads the skin, thereby improving the injection process.

The separating action may be achieved in any number of ways. As shown, the separation apparatus 502 is an actuator that is in communication with the compressed gas canister 106 and configured to be activated when the compressed gas canister 106 is activated. Alternately, there may be a gradual separation that occurs progressively as the two base pieces 520A, 520B are moved into the housing 102. For example, angled surfaces may be present on the 520A, 520B and may interact with cooperating angled surfaces on the housing 102 to cause the two base pieces 520A, 520B to progressively separate as the two base pieces 520A, 520B move into the housing 102. The auto injector 500 shown in FIGS. 5A-5B may include an adhesive on at least a portion of its base pieces 520A, 520B to allow for easier spreading of the skin during use.

FIG. 6A to FIG. 6B are schematic views of another example embodiment of an auto injector 600 disclosed herein. A shape of the auto injector 600 is configured to resemble the shape of a computer mouse and example dimensions are shown. Visible are the housing 602, the activation button 626, and the viewing window 642.

FIG. 7A to FIG. 7D are various schematic views showing external and internal components of another example embodiment of an auto injector 700 disclosed herein.

As can be seen in FIG. 7A to FIG. 7B, the auto injector 700 includes a housing 702, two needles 714 that remain in a fixed position and that are laterally disposed relative to a longitudinal axis 760 of the housing 702, a base 720 that at least partially shrouds the two needles 714 when in the unactivated position, and in some embodiments, the base may fully shroud the two needles, and wherein said base 720 can be pushed into the housing 702, an activation button 726, and the viewing window 742.

In one embodiment, a height of the auto injector 700 may be between 0.5-5 inches. In one particular, non-limting embodiment, the height of the auto injector is 1 .4 inches. In one embodiment, a width of the auto injector may be between 0.5 and 10 inches. In one particular, non-limiting embodiment, the width of the auto injector may include 2.25 inches. In yet another embodiment, a length of the auto injector may include 0.5-10 inches. In a particular, non-limiting embodiment, the length of the auto injector may include 3.75 inches. In an embodiment wherein the auto injector is 1 .4 inches in height, 2.25 inches in width and 3.75 inches in length, auto injector 700 is wider (along two axes) than tall (along the third axis) and the resulting low center of gravity provides a very stable auto injector 700. Other dimensions are possible. It is preferred to keep the height not greater than two (2) inches.

As can be seen in FIG. 7C to FIG. 7D, auto injector 700 includes a housing 702 that defines an interior volume 704, a compressed gas canister 706 configured to contain compressed gas 708, and a flexible package 710 configured to contain a medicament 712. In this example embodiment, a bladder 762, which may comprise an inflatable bladder, is disposed in the interior volume 704, and is in fluid communication with the compressed gas canister 706. The inflatable bladder 762 may be configured to receive compressed gas 708 that is released from the compressed gas canister 706 during use in one embodiment. During the transition to the activated state, the release of the compressed gas 708 may at least partially inflate the inflatable bladder 762 and inflation of the inflatable bladder 762 may cause the associated compression of the flexible package 710. In this example embodiment, the inflatable bladder 762 may press directly against the flexible package 710 to compress the flexible package 710 and dispense the medicament through at least one of the two needles 714. In another embodiment, this action causes delivery of medicament through both of the two needles 714. The flexible package 710 rests on a package platform 764 to aid in the compression of the flexible package 710 by squeezing the flexible package 710 between the inflatable bladder 762 and the package platform 764.

FIG. 8A to FIG. 8F include various schematic views showing an example embodiment of a workflow associated with the auto injector of FIG. 7A.

In a first step shown in FIG. 8A, the auto injector 700 is handled and the medicament 712 is inspected. In a second step shown in FIG. 8B, the auto injector 700 is aligned on a preferred injection site. In this example embodiment, the preferred injection site is the abdomen. Other injection sites are also possible, such as the thigh and the shoulder.

In a third step shown in FIG. 8C to FIG. 8F, the auto injector 700 is pressed down on the skin of the injection site and the activation button 726 is pressed. In this embodiment, pressing the auto injector 700 pushes the base 720 into the housing 702 to expose the needles 714, causing the needles to penetrate the skin. Pressing the activation button 726 releases the compressed gas 708 into the inflatable bladder 762. The inflatable bladder 762 inflates, which compresses the flexible package 710. As the flexible package 710 is compressed, the medicament 712 is ejected through the needles 714 into the skin. The delivery of medicament 721 may continue until the injection is complete, in one embodiment.

FIG. 9A to FIG. 9B are various schematic views showing external and internal components of another example embodiment of an auto injector 900 disclosed herein.

The auto injector 900 includes a housing 902 that defines an interior volume 904, a compressed gas canister 906 configured to contain compressed gas 908, and a flexible package 910 configured to contain a medicament 912, two needles 914 that remain in a fixed position and that are aligned with a longitudinal axis 960 of the housing 902, an activation button 926, an inflatable bladder 962, and a package platform 964. There is no base in this example embodiment, so the needles are exposed. An optional removable protective and/or sterile cover for the needles 914 may be separately provided.

FIG. 10A to FIG. 10C are various schematic views showing an example embodiment of a workflow associated with the auto injector 900 if FIG. 9A.

In a first step that is similar to that of FIG. 8A but not separately shown, the auto injector 900 is handled and the medicament 912 is inspected. In a second step that is similar to that of FIG. 8B but not separately shown, the auto injector 900 is aligned on a preferred injection site.

In a third step shown in FIG. 10A to FIG. 10C, the auto injector 900 is pressed down on the skin of the injection site and the activation button 926 is pressed. In this embodiment, pressing the auto injector 900 simply causes the fixed needles 914 to penetrate the skin. Pressing the activation button 926 releases the compressed gas 908 into the inflatable bladder 962. The inflatable bladder 962 inflates, which compresses the flexible package 910. As the flexible package 910 is compressed, the medicament 912 is ejected through the needles 914 into the skin until the injection is complete.

FIG. 11 A to FIG. 11 B are various schematic views showing external and internal components of another example embodiment of an auto injector 1100 disclosed herein.

As can be seen in FIG. 11A to FIG. 11B, the auto injector 1100 includes a housing 1102 that defines an interior volume 1104, a compressed gas canister 1106 configured to contain compressed gas 1108, a flexible package 1110 configured to contain a medicament 1112, two needles 1114 that remain in a fixed position and that are disposed along a longitudinal axis 1160 of the housing 1102, a base 1120 that fully shrouds the two needles 1114 when in the unactivated position and that can be pushed into the housing 1102, a gas activation feature 1122, an inflatable bladder 1162 disposed in the interior volume 1104, and a package platform 1164. There is no activation button in the example embodiment. The activation/release of the compressed gas 1108 occurs when the base 1120 is pushed into the housing 1102 enough to cause the gas activation feature 1122 to activate the compressed gas canister 1106 and release the compressed gas 1108.

FIG. 12A to FIG. 12D are various schematic views showing an example embodiment of a workflow associated with the auto injector of FIG. 11 A. In a first step that is similar to that of FIG. 8A but not separately shown, the auto injector 1100 is handled and the medicament 1112 is inspected. In a second step that is similar to that of FIG. 8B but not separately shown, the auto injector 1100 is aligned on a preferred injection site.

In a third step shown in FIG. 12C to FIG. 12D, the auto injector 1100 is pressed down on the skin of the injection site. In this embodiment, pressing the auto injector 1100 pushes the base 1120 into the housing 1102 to expose the fixed needles 1114, which penetrate the skin. Pushing the base 1120 into the housing 1102 causes the gas activation feature 1122 to activate/release the compressed gas 1108 into the inflatable bladder 1162. The inflatable bladder 1162 inflates, which compresses the flexible package 1110. As the flexible package 1110 is compressed, the medicament 1112 is ejected through the needles 1114 into the skin until the injection is complete.

FIG. 13 is a schematic view of another example embodiment of an auto injector 1300 disclosed herein. In this auto injector 1300, a removable cartridge 1370 having at least a flexible package (not shown) of medicament (not shown) can be installed, an injection can be delivered, and the removable cartridge 1370 can be replaced with a fresh removable cartridge to thereby ready the auto injector 1300 for the next injection. Alternately, the flexible package (not shown) of medicament (not shown) can be removed from the removable cartridge 1370 and the removable cartridge 1370 with a fresh flexible package (not shown) of medicament (not shown) can be installed for the next injection.

FIG. 14 is a schematic view showing external and internal components of another example embodiment of an auto injector 1400 disclosed herein.

Like the example embodiment of FIG. 9, the auto injector 1400 of FIG. 14 includes a housing 1402 that defines an interior volume 1404, a compressed gas canister 1406 configured to contain compressed gas 1408, and a flexible package 1410 configured to contain a medicament 1412, two needles 1414A, 14B that remain in a fixed position and that are aligned with a longitudinal axis 1460 of the housing 1402, an activation button 1426, an inflatable bladder 1462, and a package platform 1464. There is no base in this example embodiment, so the needles are exposed. An optional removable protective and/or sterile cover for the needles 1414 may be separately provided. In this example embodiment, the flexible package 1410 includes a first compartment 1410A having a first medicament 1412A and a second compartment 141 OB having a second medicament 1412B. The first compartment 1410A and the second compartment 141 OB may be separated from each other by a partition 141 OP. The first compartment 1410A is operatively associated with the first needle 1414A and the second compartment 141 OB is operatively associated with the second needle 1414B.

The workflow associated with the auto injector of FIG. 14 may be the same as the workflow associated with the auto injector of FIG. 9A. However, when the inflatable bladder 1462 inflates, it compresses both the first compartment 1410A and the second compartment 141 OB while the partition 141 OP remains intact. This, in turn, ejects the first medicament 1412A from the first needle 1414A and the second medicament from the second needle 1414B.

The distance 1414D between the centers of the needles 1414A, 1414B can vary depending on the application. In instances where the injections are to be considered separate events by the body, the needles 1414A, 1414B should be spaced a minimum of one (1 ) inch apart to align with current guidelines established by the Centers for Disease Control and Prevention. In instances where the first medicament 1412A is related to the second medicament 1412B, the needles should be located closer together than one (1 ) inch. An example of the latter is where one medicament may aid in the absorption of the other medicament.

In an alternate example embodiment, the partition 141 OP remains intact until the inflatable bladder 1462 presses on the flexible package 1410. Subsequently, the partition 141 OP breaks and allows the first medicament 1412A and the second medicament 1412B to mix before and/or during the injection process.

In this example embodiment, the auto injector 1500 includes a housing 1502 that defines an interior volume 1504, a compressed gas canister 1506 configured to contain compressed gas 1508, a flexible package 1510 configured to contain a medicament 1512, a base 1520, and a gas activation feature 1522. In this example embodiment, an inflatable bladder 1562 is disposed in the interior volume 1504, is in fluid communication with the compressed gas canister 1506, and is configured to receive compressed gas 1508 that is released from the compressed gas canister 1506. The inflatable bladder 1562 of this example embodiment at least partly surrounds the flexible package 1510.

Like the example embodiment of FIG. 1 , movement of the gas activation feature 1522 with the base 1520 as the base 1520 is pressed inward causes the transition to the activated state. During the transition to the activated state, the release of the compressed gas 1508 inflates the inflatable bladder 1562. The compressed gas 1508 is then trapped in a space 1570 between the inflatable bladder 1562 and the flexible package 1510 and acts directly upon the flexible package 1510 to expel the medicament 1512. While the flexible package 1510 and the inflatable bladder 1562 shown are spherical, any suitable shape can be used.

In an alternate example embodiment, the inflatable bladder 1562 may have a different shape such as a shape of a ring and the flexible package 1510 may be at least partly disposed inside the ring. Expansion of the inflatable bladder 1562 would reduce an inner diameter of the ring which would compress the flexible package 1510 and thereby expel the medicament 1512.

FIG. 16A and FIG. 16B are end views of an example embodiment of an auto injector 1600 (without a movable base) disclosed herein. Gravity exerts a gravitational force on a center of gravity 1620 of the auto injector 1600 in a direction of gravity 1622. When the bottom of the auto injector 1600 (the part in contact with the surface, which can be the movable base in other example embodiments), is parallel to the horizon 1624, a tilt angle 1626 between the direction of gravity 1622 and a normal 1628 of the bottom 1654 is zero. As the auto injector 1600 rotates from being horizontally oriented, the tilt angle 1626 increases.

So long as the center of gravity 1620 is disposed horizontally between ends 1654L, 1654R of the bottom 1654, (as shown in FIG. 16B), the auto injector 1600 will not topple over. For example, the auto injector 1600 of FIG. 16B has been tilted from the horizontal position shown in FIG. 16A. The center of gravity 1620 remains disposed horizontally between the ends 1654L, 1654R. If the auto injector 1600 in FIG. 16B is released, it will return to the position shown in FIG. 16A. However, if the auto injector

that is horizontally past the end 1654R, (as shown in FIG. 16B), the auto injector 1600 (which is not otherwise constrained) will topple over under the influence of gravity. When the center of gravity 1620 reaches an end 1614L, 1614R, the tilt angle 1626 is the maximum tilt angle. Upon exceeding the maximum tilt angle, an unconstrained body will then topple over.

In the example embodiment shown, in which the width of the bottom 1654 is 2.25” and the center of gravity 1620 is, for example, 3/4 inch above the bottom 1654 as shown in FIG. 16A, the tilt angle 1622 can reach up to approximately 56 degrees (the maximum tilt angle of this configuration) before the center of gravity 1620 reaches the right end 1654R.

In another example embodiment, the center of gravity 1620 is 1 .125” above the bottom 1654 as shown in FIG. 16A. In this example embodiment, the maximum tilt angle 1626 is 45 degrees. Dimensions of various example embodiments disclosed herein are selected to ensure that when in position to deliver medication, the maximum tilt angle 1626 exceeds 45 degrees.

The maximum tilt angle 1626 is a property of the auto injector 1600 that is determined by the geometry of the auto injector 1600 in isolation. For example, if the bottom 1654 of the auto injector 1600 of FIG. 16B is firmly adhered to a surface, the auto injector 1600 of FIG. 16B may not topple over if tilted past the maximum tilt angle because the bottom 1654 is adhered to the surface. Nonetheless, the maximum tilt angle remains unchanged.

Adhesive 1652 may optionally be disposed on the bottom 1654 of the auto injector 1600. The adhesive 1652 may be applied to most or all of the bottom (as shown in FIG. 1 D) or may be selectively applied to the bottom 1654 as shown in FIG. 16A and FIG. 16B. A total adhesive force of an auto injector 1600 with adhesive 1652 applied is influenced at least by an adhesive strength of the adhesive and an amount of an area of the bottom 1654 to which the adhesive 1652 is applied. By selectively choosing an adhesive material with a suitable adhesive strength, and selectively choosing how much area of the bottom 1654 to which the adhesive 1652 is applied, one can achieve a desired total adhesive force. A relatively greater adhesive force can be achieved by using an adhesive 1652 with a high relatively adhesive strength and applying it to most or all of the bottom 1654. Alternately, a relatively lesser adhesive force can be achieved by using an adhesive 1652 with relatively a low adhesive strength and applying it to less than all of the bottom 1654.

In an example embodiment, the adhesive strength is not sufficient to bond the auto injector 1600 to the surface (e.g., skin) to which the auto injector 1600 is adhered to the extent that the auto injector 1600 remains attached to the surface at all tilt angles. The adhesive strength results in an adhesion that is more tacky than sticky.

In an example embodiment, the adhesive 1652 has an adhesive strength that is sufficient to prevent sliding of the auto injector 1600 along a surface to which the bottom 1654 is adhered up to a respective tilt angle of the auto injector 1600. Beyond the respective tilt angle, the adhesive strength is insufficient (in shear) to prevent the auto injector 1600 from sliding along the surface and/or insufficient (in tension) to prevent the auto injector 1600 from separating from the surface should the respective tilt angle be exceeded.

In an example embodiment, the respective tilt angle is the respective maximum tilt angle of the auto injector 1600.

In an example embodiment, the respective tilt angle is less than the respective maximum tilt angle of the auto injector 1600.

In an example embodiment, the respective tilt angle is greater than the respective maximum tilt angle of the auto injector 1600 but less than one hundred eighty (180) degrees. In an example embodiment, the adhesive 1652 has an adhesive shear strength that is insufficient to prevent sliding of the auto injector 1600 along the surface to which the bottom 1654 is adhered at a respective tilt angle of the auto injector 1600 of ninety (90) degrees.

In an example embodiment, the adhesive 1652 has an adhesive shear strength that is sufficient to prevent sliding of the auto injector 1600 along the surface to which the bottom 1654 is adhered at respective tilt angles of the auto injector 1600 of up to ninety (90) degrees, but is insufficient to prevent sliding of the auto injector 1600 along the surface to which the bottom 1654 is adhered at a respective tilt angle of the auto injector 1600 of ninety (90) degrees.

In an example embodiment, the adhesive 1652 has an adhesive tensile strength that is insufficient to prevent separation of the auto injector 1600 from the surface to which the bottom 1654 is adhered at a respective tilt angle of the auto injector 1600 of one hundred eighty (180) degrees.

In an example embodiment, the adhesive 1652 has an adhesive tensile strength that is sufficient to prevent separation of the auto injector 1600 from the surface to which the bottom 1654 is adhered at respective tilt angles of the auto injector 1600 of up to one hundred eighty (180) degrees, but is insufficient to prevent separation of the auto injector 1600 from the surface to which the bottom 1654 is adhered at a respective tilt angle of the auto injector 1600 of one hundred eighty (180) degrees.

The auto injector embodiments disclosed herein may be entirely or partly disposable. In an example embodiment, the housing 102 may be composed of paper molded pulp and thereby disposable as recyclable paper, which would reduce the environmental impact.

While various embodiments of the present invention have been shown and described herein, it will be obvious that such embodiments are provided by way of example only. Numerous variations, swapping of features among embodiments, changes, and substitutions may be made without departing from the invention herein. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

Claims

CLAIMS The invention claimed is:

1 . An injection device, comprising: a housing that defines an interior volume; a compressed gas canister configured to contain a compressed gas; a package disposed in the interior volume and configured to contain a medicament; and a needle; wherein during a transition to an activated state of the injection device, the injection device is configured to cause a release of the compressed gas and thereby cause delivery of medicament from the package; and wherein the release creates a flow of the medicament out of the package via the needle.

2. The injection device of claim 1 , wherein the package further comprises a flexible package, and wherein during the transition to the activated state the compressed gas is released into the interior volume of the housing and is in direct contact with the flexible package to cause the associated compression of the flexible package.

3. The injection device of claim 2, further comprising an inflatable bladder in the interior volume; wherein during the transition to the activated state the release of the compressed gas inflates the inflatable bladder and inflation of the inflatable bladder causes the associated compression of the flexible package.

4. The injection device of claim 3, wherein the inflatable bladder is in direct contact with the flexible package.

5. The injection device of claim 3, wherein the inflatable bladder at least partly surrounds the flexible package.

6. The injection device of claim 5, wherein the compressed gas is released into and trapped in a space between the inflatable bladder and the flexible package and compresses the flexible package.

7. The injection device of claim 1 , further comprising a base that is selectively positionable relative to the housing; wherein pressing the base into the housing automatically causes the transition to the activated state.

8. The injection device of claim 1 , further comprising an activation button, wherein pressing the activation button causes the transition to the activated state.

9. The injection device of claim 1 , further comprising an adhesive disposed on a bottom surface of the housing.

10. The injection device of claim 1 , further comprising a base that is selectively positionable relative to the housing.

11 . The injection device of claim 10, wherein the needle is in a fixed position; and wherein in an inactivated state of the injection device the base fully shrouds a tip of the needle.

12. The injection device of claim 11 , wherein pressing the base into the housing exposes the needle.

13. The injection device of claim 1 , further comprising a needle activation assembly comprising the needle and configured to extend the needle during the transition to the activated state.

14. The injection device of claim 2, the housing further comprising a viewing window configured to enable viewing of the flexible package as the flexible package is compressed.

15. The injection device of claim 10, further comprising a selectively positionable locking switch configured to prevent the base from being moved into the housing when the locking switch is in a locked position.

16. The injection device of claim 10, further comprising a selectively positionable needle guard configured to prevent the needle from protruding past the base when the needle guard is in a guarded position.

17. The injection device of claim 10, further comprising an adhesive disposed on a bottom surface of the base.

18. The injection device of claim 17, wherein the adhesive comprises an adhesive shear strength that is insufficient to prevent sliding of the injection device along a surface to which the bottom surface of the base is adhered when the injection device is disposed at a tilt angle of ninety (90) degrees.

19. The injection device of claim 17, wherein the adhesive comprises an adhesive tensile strength that is insufficient to prevent separation of the injection device from a surface to which the bottom surface of the base is adhered when the injection device is disposed at a tilt angle of one hundred eighty (180) degrees.

20. The injection device of claim 17, further comprising a sterile peel strip disposed on the adhesive on the bottom surface and effective to keep the needle sterile.

21 . The injection device of claim 17, further comprising a positive stop peel strip disposed on the adhesive on the bottom surface and effective to act as a positive stop by abutting the needle when the base is moved toward the housing.

22. The injection device of claim 2, further comprising a second needle, wherein the compression also creates a second flow of the medicament out of the flexible package via the second needle.

23. The injection device of claim 2, further comprising a second needle; wherein the flexible package comprises: a first compartment configured to contain the medicament and to deliver the medicament through the needle during the compression; and a second compartment configured to contain a second medicament and to deliver the second medicament through the second needle during the compression.

24. The injection device of claim 2, further comprising a medicament seal disposed inside the flexible package between the medicament and the needle, wherein the compression causes the needle to pierce the medicament seal and establish the flow of the medicament out of the flexible package.

25. The injection device of claim 10, wherein the base comprises a thermally conductive plate that defines at least a portion of a bottom surface of the base.

26. The injection device of claim 25, wherein the injection device is configured to direct compressed gases being released from the compressed gas canister onto the thermally conductive plate to cool the thermally conductive plate.

27. The injection device of claim 10, wherein the base comprises two base pieces and a separation injection device, and wherein during the transition to the activated state the separation injection device spreads the two base pieces apart.

28. The injection device of claim 1 , wherein an overall height of the injection device is under two (2) inches.

29. The injection device of claim 2, further comprising a removable cartridge comprising the flexible package.

30. An injection device, comprising: a housing; a compressed gas canister configured to contain a compressed gas; a flexible package configured to contain a medicament; and a needle; wherein the injection device is configured to be transitioned from an unactivated state to an activated state; and wherein during a transition to the activated state the injection device is configured to release the compressed gas; to cause released compressed gas to cause the flexible package to be compressed; and to eject the medicament from the flexible package via the needle as the flexible package is compressed.

31 . The injection device of claim 30, wherein the injection device is configured to release the compressed gas into an interior volume of the housing and to put the compressed gas into direct contact with the flexible package to compress the flexible package.

32. The injection device of claim 30, further comprising an inflatable bladder in an interior volume of the housing; wherein the injection device is configured to release the compressed gas into the inflatable bladder to inflate the inflatable bladder and thereby compress the flexible package.

33. The injection device of claim 30, further comprising a base that is selectively positionable relative to the housing.

34. The injection device of claim 33, wherein the injection device is configured to be transitioned from the unactivated state to the activated state by pushing the base into the housing.

35. The injection device of claim 30, further comprising an activation button; wherein the injection device is configured to be transitioned from the unactivated state to the activated state by pushing the activation button.

36. The injection device of claim 30, further comprising a needle activation assembly comprising the needle and configured to extend the needle during the transition to the activated state.

37. The injection device of claim 30, further comprising a second needle, wherein during the transition to the activated state the injection device is configured to also eject the medicament from the flexible package via the second needle.

38. The injection device of claim 30, wherein an overall height of the injection device is under two (2) inches.

39. An injection device, comprising: a housing; a compressed gas canister configured to contain a compressed gas; a flexible package configured to contain a medicament; and a needle; wherein during a transition to an activated state of the injection device the injection device is configured to release the compressed gas and thereby compress the flexible package; and wherein at least when the flexible package is being compressed a flow path exists that originates inside the flexible package and that exits the flexible package via the needle.

40. The injection device of claim 39, wherein the injection device is configured to release the compressed gas into an interior volume of the housing and to put the compressed gas into direct contact with the flexible package to compress the flexible package.

41 . The injection device of claim 39, further comprising an inflatable bladder; wherein the injection device is configured to release the compressed gas into the inflatable bladder to inflate the inflatable bladder and thereby compress the flexible package.

42. The injection device of claim 39, further comprising a base that is selectively positionable relative to the housing; wherein the injection device is configured to be transitioned to the activated state by pushing the base into the housing.

43. The injection device of claim 39, further comprising an activation button; wherein the injection device is configured to be transitioned to the activated state by pushing the activation button.

44. The injection device of claim 39, further comprising a needle activation assembly comprising the needle and configured to extend the needle during the transition to the activated state.

45. The injection device of claim 39, further comprising a second needle; wherein during the transition to the activated state the injection device is configured to also eject the medicament from the flexible package via the second needle.

46. The injection device of any one of claims 1 , 30, and 39, wherein the injection device comprises an auto injector.