DRIVE MODULE FOR AN INJECTOR AND SYSTEM AND METHOD USING SUCH DRIVE MODULE - Patent application

Abstract

An injection device for delivering a medicament into a subject's body includes a drive module and an injector module. The drive module includes a canister and a puncture mechanism in a first chamber, a plunger in a second chamber communicating with the first chamber, and an actuator for moving the puncture mechanism to cause the puncture pin to pierce a septum of the canister and cause gas in the canister to flow through the first chamber and into the second chamber. The plunger includes a proximal end and a distal end including a piston, and is configured such that gas entering the second chamber moves the plunger from an initial position to an extended position for delivering one or more medicaments from the injector module, the piston including one or more passages allowing gas from the canister to pass through the piston and into the second chamber around the plunger.

Description

[Technical field]

[0001] The present application relates generally to devices and methods for delivering medicaments into the body of a subject, and more particularly to automatic injectors and / or gas-powered drive systems for injection devices, as well as methods of making and using such devices.

[0002] Related Application Data This application claims the benefit of co-pending U.S. Provisional Application No. 63 / 255,884, filed October 14, 2021, the entire disclosure of which is expressly incorporated herein by reference. [Background technology]

[0003] There are many applications involving the delivery of drugs or other agents into a patient's body, either subcutaneously, intramuscularly, or otherwise. For example, auto-injectors are available that contain a preset dose of an agent that is automatically delivered into the patient's body after application to the patient's skin and actuation. Typically, such auto-injectors are spring-loaded syringes that, upon actuation, release a spring, which generates sufficient force to cause the needle to penetrate the skin and deliver the dose in the syringe. For viscous fluids, the force required to cause the fluid flow may be greater than what a spring-powered system can provide. If a spring is used, a relatively large force must be generated, which requires a spring with a large mass. As a result, such auto-injectors can make significant noise, generate pressure spikes in the syringe that can lead to glass breakage, vibrate, and / or drive the needle into the patient's skin, which can cause pain and / or frighten the user, especially if the patient is performing the injection himself.

[0004] Therefore, improved devices and methods for delivering pharmaceutical agents into the body of a patient would be useful. Summary of the Invention

[0005] The present application relates generally to devices and methods for delivering medicaments into the body of a subject, and more particularly to automatic injectors and / or gas-powered drive systems for injection devices, as well as methods of making and using such devices.

[0006] According to one embodiment, there is provided a drive module for an injection device for delivering one or more medicaments into a body of a subject, the drive module comprising: an elongated drive housing including a first end and a second end and a chamber; a pressurized gas source in communication with a passageway into the chamber; a proximal end including a piston and a distal end and a plunger slidably disposed within the chamber, wherein gas entering the passageway into the chamber is configured to move the plunger from an initial position to an extended position, wherein the distal end of the plunger extends from the second end of the drive housing to deliver one or more medicaments from the injector module based on movement of the plunger; and a plunger including one or more passageways configured to allow gas from a canister entering the chamber to pass through the piston and into the chamber around the plunger. Optionally, the plunger includes a plunger chamber extending from an opening at the proximal end in communication with the second, wherein pressurized gas from the canister entering the chamber can fill the plunger chamber.

[0007] According to another embodiment, there is provided a device for delivering one or more medicaments into a patient's body, the device including: a) a drive module, the drive module including an elongated drive housing having a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end via an intermediate passage; a puncture mechanism in the first chamber adjacent the first end, the puncture mechanism including a puncture pin; a canister containing pressurized gas including a pierceable septum disposed adjacent the puncture pin; and a drive module configured to drive one of the puncture mechanism and the canister to puncture the puncture pin. the actuator configured to pierce the septum with a piston and pass gas in the canister through the first chamber around the canister and through the intermediate passage into the second chamber; and a plunger slidably disposed within the second chamber having a proximal end and a distal end including a piston, wherein gas entering the second chamber from the passage is configured to move the plunger from an initial position to an extended position, wherein the distal end of the plunger extends from the second end of the drive housing for delivery of one or more medicaments from the injector module based on movement of the plunger. The device also includes an injector module coupled to the drive housing and comprising: an injector housing holding a medicament chamber containing one or more medicaments; a piston slidably disposed within the medicament chamber and coupled to a distal end of the plunger; and a needle extending from the injector module opposite the drive housing and in communication with the medicament chamber for delivering the one or more medicaments from the medicament chamber when the plunger moves from a retracted position to an extended position to advance the piston within the medicament chamber, the piston including one or more passageways configured to allow gas from a canister entering the first chamber to pass through the piston and into the chamber around the plunger.

[0008] The devices herein can be used to perform injections, for example, to perform a method comprising the steps of inserting a needle into a patient's skin and actuating an actuator to deliver pressurized gas from a source through a passageway into a chamber, thereby moving a plunger from an initial position to an extended position, thereby advancing a piston in the medication chamber to deliver one or more medications into the patient's body through the needle.

[0009] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0010] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings, in which: It is emphasized that, according to common practice, the various features and design elements of the drawings are not drawn to scale. Conversely, dimensions of the various features and design elements have been arbitrarily expanded or reduced for clarity. The drawings include the following figures: [Figure 1] FIG. 1 is a side view of an exemplary autoinjector device. [Diagram 2] 2A and 2B are cross-sectional views of the autoinjector device of FIG. 1 taken along plane AA, showing details of the gas-powered drive module and the injector module. [Diagram 3] 3A and 3B are cross-sectional views of an example of a gas-powered drive module that can be incorporated into the device of FIGS. 1-2B, showing the drive module before and after actuation, respectively. [Figure 4] 4A and 4B are side cross-sectional views of an alternative example of a drive unit for a gas-powered injector, similar to the drive module shown in FIGS. 3A and 3B, but with the canister and pin mechanism in reverse orientation. [Diagram 5] 5A and 5B are side cross-sectional views of a syringe driver that minimizes force drop during advancement of the driver's plunger. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Before describing the embodiments, it is to be understood that the invention is not limited to particular embodiments described, as such may, of course, vary, and the scope of the present invention will be limited only by the appended claims. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0012] Where a range of values ​​is given, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, is also specifically disclosed unless the context clearly dictates otherwise. Each smaller range between any stated value or intervening value in a stated range and any other stated value or intervening value in a stated range is encompassed within the invention. The upper and lower limits of such smaller ranges may each be independently included or excluded within the range, and each range is encompassed within the invention, whether or not both or either are included in the smaller range, subject to the specifically excluded limit in the stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also intended to be included within the invention.

[0013] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some possible exemplary methods and materials are described herein.

[0014] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "compound" includes a plurality of such compounds, and a reference to a "polymer" includes a reference to one or more polymers and equivalents thereof known to those skilled in the art.

[0015] In this specification, certain ranges are indicated by the term "about" before the numerical values. The term "about" is used in this specification to provide literal support for the exact numerical value following the term and for a numerical value close to or close to the numerical value following the term. In determining whether a numerical value is close to or close to a specifically stated numerical value, the close or close unstated numerical value may be a numerical value that provides a substantial equivalent to the specifically stated numerical value in the context in which it is presented.

[0016] Returning to the drawings, FIGS. 1-3B show an example of an injection device 8 including a gas-powered drive cartridge or module 10 and an injector cartridge or module 60 coupled to the drive module 10, which may include similar components and / or function similarly to any of the examples described herein. Overall, the device 8 is an automatic injector having a drive module 10 that, upon actuation, provides a force or power to automatically deliver one or more agents contained within the injector module 60, as described elsewhere herein, similar to the injector disclosed, for example, in U.S. Pat. No. 11,071,824, the entire disclosure of which is expressly incorporated herein by reference. As used herein, an "agent" may include one or more therapeutic and / or diagnostic compounds or materials, for example, in liquid or gas form, in solution or suspension, and in viscous fluids.

[0017] Figures 3A and 3B show one example of a drive module 10 that may be incorporated into an automatic injector 8 (or other injection device) used to deliver one or more medications into a subject's body. Figures 4A and 4B show a drive module 10 in which the canister 40 and pin mechanism 30 are reversed, but which otherwise operates similarly. In one example, the drive module 10 may be integrated into or coupled to a syringe module or other injection device that contains the medication.

[0018] Generally, drive module 10 includes an elongated drive housing 12 that houses a puncture mechanism 30 including a puncture pin 34, a gas canister or other source of pressurized gas 40, and a plunger 50. Housing 12 includes a sealed first or proximal end 14 and an open second or distal end 16 aligned along a longitudinal axis 18. Housing 12 may be formed as a single, integral component, for example, from a metal such as steel, aluminum, plastic, and / or composite material by one or more of cold drawing, molding, casting, machining, etc. Alternatively, housing 12 may be formed from multiple separate components that are substantially permanently attached to one another, for example, by one or more of welding, soldering, fusing, adhesive bonding, interference fitting, etc.

[0019] The housing 12 includes a first or proximal portion 20 adjacent the first end 14 that defines a first chamber 22 for receiving the canister 40 and the puncture mechanism 30, and a second or distal portion 24 adjacent the second end 16 that defines a second chamber 26 that communicates with the first chamber 22 via an intermediate passage 28. Both housing portions 20, 24 may have a generally cylindrical or other suitable shape, for example, defining a substantially uniform outer and / or inner diameter.

[0020] As shown, the puncture mechanism 30 may be disposed within the first chamber 22 adjacent the intermediate passage 28, and the canister 40 may be disposed proximally relative to the puncture mechanism 30, with a septum 44 of the canister 40 initially spaced from the puncture pin 34. Alternatively, the puncture mechanism 30 may be disposed within the first chamber 22 immediately adjacent the first end 14, and the canister 40 containing compressed gas may be disposed within the first chamber 22 adjacent to the puncture mechanism 30, e.g., with the puncture pin 34 also initially spaced from the septum 44.

[0021] Generally, and with particular reference to FIGS. 3A and 3B, the canister 40 includes a body 42 and a cap 44 including a septum 46 joined to the body 42, thereby providing a sealed cavity 48 filled with a fluid including a liquefied gas, such as carbon dioxide or a fluorocarbon gas, compressed to a pressure sufficient to at least partially liquefy the gas in the cavity 48. Alternatively, a fluid that remains in a gaseous state can be stored in the cavity 48, including a gas such as argon, nitrogen, helium argon, or other combinations thereof. As described elsewhere herein, the fluid contained in the cavity 48 can be used to drive the infusion device 8 to provide a desired potential energy or expelling force, for example, to inject one or more agents from the injector module 60 into the patient's body. In one example, the body 42 and cap 44 can be formed from stainless steel or other desired or suitable metal, plastic, or composite material, for example, by one or more of drawing, pressing, machining, casting, molding, and the like. For example, the body 42 may be deep drawn from a round sheet metal blank, such as type 305 stainless steel, using one or more dies and punches (not shown) to form a main barrel region 42a, a closed base or first end 42b, a tapered shoulder region 42c, and an open neck region or second end 42d that defines an opening or passageway into which the cap 44 is attached. Additional information regarding usable canisters and methods of making the same can be found in U.S. Publication No. 2017 / 0258583, the entire disclosure of which is expressly incorporated herein by reference.

[0022] 3A and 3B, the puncture mechanism 30 includes a pin sleeve 32 slidably disposed about the first chamber 22 adjacent the first end 14, i.e., between the second end 42d and cap 44 of the canister 40 and the proximal wall 14a, and / or sealed by proximal and distal O-rings surrounding the first chamber 22. The pin sleeve 32 carries a puncture pin 34 and is axially movable within the first chamber 22, as described elsewhere herein, between, for example, an inactivated position in which the puncture pin 34 is spaced apart from the septum 46 (FIG. 3A), and an activated position in which the puncture pin 34 pierces the septum 46 to release gas from the cavity 48 of the canister 40 (FIG. 3B).

[0023] The pin sleeve 32 may be biased to the actuated position and restrained in the inoperative position, for example, by one or more catches 36 in the drive housing 12 that restrain the pin sleeve 32 in the inoperative position. For example, a compression spring 38 may be disposed about the pin sleeve 32 and / or otherwise coupled between the housing 12 and the pin sleeve 32 to urge the pin sleeve 32 from the inoperative position to the actuated position upon actuation.

[0024] 3A and 3B, the spring 38 may be captured between the distal flange 32a of the pin sleeve 32 and the proximal wall 14a of the drive housing 12. A pair of catches 36 may be attached to the drive housing 12 and are pivotable from an outward position (FIG. 3A) in which the catches 36 contact the distal flange 32a to prevent movement of the pin sleeve 32 from the inactivated position to an inward position (not shown) in which the catches 36 release the distal flange 32a to allow the spring 38 to guide the pin sleeve 32 distally to the activated position, e.g., a sufficient distance for the puncture pin 34 to penetrate the septum 46 of the canister 40.

[0025] When septum 46 is pierced, gas within cavity 48 is released into first chamber 22 such that, for example, gas travels distally around canister 40 and through intermediate passage 28 into second chamber 26. For example, drive housing 12 and canister body 42 may have corresponding diameters that provide sufficient clearance to allow gas to travel distally within first chamber 22, around canister 40, and into intermediate passage 28, as described elsewhere herein.

[0026] Optionally, the intermediate passage 28 can have a relatively small diameter to provide a restrictor to reduce pressure rise time. Alternatively, if desired to function as a restrictor, a precision orifice (not shown) can be inserted between the first and second chambers 22, 26. For example, the orifice can i) slow the transient flow of gas and slow the rise in pressure applied to the plunger 50, e.g., providing a soft start to the injection, reducing / eliminating pressure shock waves in the injected fluid in the syringe, reducing pain to the patient as drug injection begins more gradually, and / or ii) slow the steady state flow of gas and reducing other pressures applied to the plunger 50, providing a limiting effect on the flow rate of drug injected to the patient.

[0027] 1-2B, generally, injector 60 includes an injector housing 62 that is coupled to drive housing 12 and houses therein a syringe 70 including a drug chamber 72 that contains one or more drugs or other medicaments. For example, injector housing 62 can include a first or proximal end 62a that can be coupled to drive housing 12, e.g., to an outer sleeve 66 to which at least a portion of drive housing 12 can be secured, e.g., using one or more of an interference fit, one or more cooperating connectors, adhesive bonding, etc., and a second or distal end 62b opposite drive housing 12. In one example, proximal end 62a of injector housing 62 communicates with interior 64 of injector housing 62, and distal end 62b is at least partially sealed.

[0028] Generally, the syringe 70 includes a barrel 74 and a piston or stopper 76 slidably disposed therein to enclose the drug chamber 72. A needle 78 can extend from a closed distal end 74a of the barrel 74. In one example, the syringe 70 can be a pre-filled syringe formed, for example, from glass, plastic, etc., and filled with a preset amount of drug, for example, corresponding to a single patient dose. The drug chamber 72 can contain one or more therapeutic and / or diagnostic drugs, for example, viscous fluids having a viscosity greater than water, for example, about 1-2000 centipoise (1.0-2000 cP), that require significant force and / or time to deliver, for example, large proteins and / or other drugs.

[0029] Optionally, the proximal end 74b of the barrel 74 may be provided with one or more flanges or other features 75 that may engage with one or more detents, ridges or other features (not shown) in the injector housing 62. For example, during manufacture or assembly, a syringe 70 may be selected (e.g., a syringe that is inserted through the proximal end 62a of the injector housing 62 into the interior 64 until a needle 78 extends partially through the distal end 62b and a flange 75 of the syringe 70 is captured by one or more features of the injector housing 62). The proximal end 62a of the injector housing 62 may then be coupled to the outer sleeve 66 of the drive module 10 to enclose the components and provide an injector device 8 that is ready for use.

[0030] Alternatively, the injector module 60 can include an integral barrel (not shown) that defines a drug chamber 72 and carries a needle 78. For example, the injector housing 62 can define a substantially enclosed drug chamber (not shown) that slidably receives a piston 76 and can include a needle 78 permanently attached to the injector housing 62 for delivering the drug in the drug chamber 72. In yet another alternative, the syringe 70 (or the injector housing 62 with integral drug chamber) can include a needle-less distal port (not shown), in which case a separate needle (also not shown) can be coupled to the port immediately prior to injection or as needed, for example, using a luer fitting, mating threads and / or other cooperating connector.

[0031] The piston 76 is coupled to the distal end 54 of the plunger 50, e.g., upon assembly of the syringe housing 62 to the outer sleeve 66, such that subsequent advancement of the plunger 50 advances the piston 76 within the medicament chamber 72 to direct one or more medicaments through the needle 78 and into the patient's body, e.g., automatically upon actuation of the puncture mechanism 30, as further described elsewhere herein. Optionally, a plunger adapter 58 can be provided that can provide an interface between the distal end 54 of the plunger 50 and the piston 76, e.g., to provide a connector therebetween and / or to ensure proper spacing so that the piston 76 advances in conjunction with the plunger 50.

[0032] Plunger 50 may be an elongated rod or other member including a proximal end 52 and a distal end 54 that is slidably disposed within second chamber 26 and is movable from an initial or retracted position (e.g., as shown in FIG. 3A ) to a final or extended position (e.g., as shown in FIG. 3B ) in which distal end 54 extends from second end 16 of drive housing 12. A piston or other seal 53, such as one or more O-rings, is provided at proximal end 52 of plunger 50 that slidably engages a wall of second chamber 26.

[0033] In use, the drive module 10 may be coupled to (or pre-integrated with) an injector module or other delivery device and used to deliver one or more medicaments within a medicament housing (not shown) of the delivery device. For example, the injector module may include an injection piston at its proximal end, a needle at its distal end, and house a syringe containing a preset amount of medicament for delivery, similar to the device disclosed in U.S. Pat. No. 11,071,824.

[0034] Once the delivery device is positioned at a desired location, e.g., by inserting a needle into a target location on a subject's body, an actuator of the delivery device is actuated to cause the puncture pin 34 to pierce the septum 44 of the canister 40, thereby allowing pressurized gas from the canister 40 to flow through the first chamber 22 and the intermediate passage 28 into the second chamber 26. The resulting pressure exerts a distal force on the piston 53, advancing the plunger 50 from an initial position (FIG. 3A) to an extended position (FIG. 3B). Alternatively, the needle may initially be clear of the patient's skin when the distal end is applied to the skin, and actuation may advance the needle to pierce the skin and deliver the medicament, and / or retract the needle after delivery, similar to the injector of U.S. Pat. No. 11,071,824.

[0035] As can be seen from FIGS. 3A and 4A, when the septum 44 is first punctured, the initial volume that the gas must fill (including the first chamber 22 around the canister 40 and the second chamber 26 proximal to the piston 53) is relatively small. However, as the plunger 50 advances, the volume in the second chamber 26 that the gas must fill increases significantly. Because the initial pressure in the canister 40 is fixed (set at the time of filling), the pressure decreases significantly as the released gas fills the increasing volume. Because the distal force that the gas exerts on the piston 53 is proportional to this pressure, the force exerted on the plunger 50 also decreases significantly as the plunger 50 moves distally. This resulting decrease in force can cause the plunger 50 to slow down as it advances, which can slow delivery times and / or cause incomplete delivery of the drug, exacerbating the force decrease, especially if the drug being delivered is viscous.

[0036] 5A and 5B, another example of a drive module 110 is shown that may be incorporated into an injection device, such as device 8, and may provide significantly reduced force drop as compared to drive module 10. Similar to drive module 10, drive module 110 includes an elongated drive housing 112 that houses a puncture mechanism 30 including a puncture pin 34, a gas canister or other source of pressurized gas 40, and a plunger 150. Housing 112 also includes a first or proximal portion 120 adjacent first end 114 that defines a first chamber 122 for receiving canister 40 and puncture mechanism 30, and a second or distal portion 124 adjacent second end 116 that defines a second chamber 126 in communication with first chamber 122 via intermediate passage 128, all of which may be configured substantially similarly to drive module 10.

[0037] The puncture mechanism 30 and canister 40 are disposed within the first chamber 122 adjacent the intermediate passage 128 with the septum 44 of the canister 40 initially spaced from the puncture pin 34, e.g., oriented distally as shown, or oriented proximally (not shown) similar to the drive module 10. Similar to the drive module 10 and the device disclosed in U.S. Pat. No. 11,071,824 (incorporated herein by reference), an actuator can be provided to move one or both of the puncture mechanism 30 and / or canister 40 to cause the puncture pin 34 to pierce the septum 44 and release gas.

[0038] Plunger 150 may be an elongated rod or other member including a proximal end 152 and a distal end 154 that is slidably disposed within second chamber 126 and is movable from an initial or retracted position (e.g., as shown in FIG. 5A ) to a final or extended position (e.g., as shown in FIG. 5B ) in which distal end 154 extends from second end 116 of drive housing 112.

[0039] Unlike the drive module 10, however, the plunger 150 includes a piston 153 at a proximal end 152, which includes one or more passages 153a extending between the proximal and distal faces of the piston 153. For example, the piston 153 can include a plurality of circular or other enclosed passages 153a spaced apart from one another around the circumference of the piston 153. Alternatively, the one or more passages can be grooves (not shown) formed in an outer surface of the piston 153 extending between the proximal and distal faces. The piston 153 can be sized and / or shaped to slidably engage the wall of the second chamber 126 to, for example, allow the plunger 150 to move from an initial position to an extended position, but does not require an O-ring or other seal. For example, the piston 153 can be a cylindrical head having a larger outer diameter than the plunger 150, and can be integrally molded or otherwise formed with the plunger 150, or can be manufactured separately and permanently attached to the plunger 150.

[0040] 5A, one or more passages 153a communicate between a region of the second chamber 126 proximal to the piston 153 and a region distal to the second chamber 126 surrounding the plunger 150. The second end 116 of the housing 112 can include one or more O-rings or other seals 117 that can slidably engage the plunger 150, for example, to provide a fluid-tight seal without substantially impeding axial movement of the plunger 150.

[0041] Optionally, the plunger 150 may also include a plunger chamber 156, e.g., extending from an open proximal end 152 to a closed distal end 154 of the plunger 150. As a result, when the septum 44 of the canister 40 is initially pierced, gas within the canister 40 may freely pass from the first chamber 122 through the intermediate passage 128 into the second chamber 126, i.e., through one or more passages 153a into the second chamber 126 around the plunger 150, and into the plunger chamber 156, as described further below.

[0042] In use, the drive module 110 may be coupled to (or pre-integrated with) an injector module or other delivery device and used to deliver one or more medicaments within a medicament housing (not shown) of the delivery device. For example, the drive module may be coupled to an injector module that contains a syringe that includes a piston at its proximal end and a needle at its distal end and contains a preset amount of medicament for delivery, similar to the device disclosed in U.S. Pat. No. 11,071,824.

[0043] Once the delivery device is positioned as desired, for example after inserting a needle into a target location on a subject's body (or applying an autoinjector to the skin), an actuator on the delivery device can be actuated to cause the puncture pin 34 to pierce the septum 44 of the canister 40, thereby passing pressurized gas from the canister 40 through the first chamber 122 and intermediate passage 128 into the second chamber 126. As with the drive module 10, the resulting pressure exerts a distal force on the plunger 150, thereby advancing the plunger 150 from an initial position (FIG. 5A) to an extended position (FIG. 5B).

[0044] However, as can be seen from FIG. 5A, when the septum 44 is first punctured, the initial volume that the gas must fill (including the first chamber 122 around the canister 40, the second chamber 126 around the plunger 150, and optionally the plunger passage 156) is substantially larger than in the drive module 10. This may result in a lower initial pressure, but as the plunger 150 advances, the change in the volume that the gas must fill increases only minimally (e.g., the volume that the plunger 150 occupies in the second chamber 126 is displaced out of the distal end 116 of the housing 112). As a result, because the volume change is minimized, the force exerted by the pressure acting on the plunger 150 remains substantially constant or is only slightly reduced, particularly compared to the drive module 10. This minimizes the reduction in the force exerted on the plunger 150, which may result in a more uniform rate of delivery of the drug from the delivery device, especially when the drug being delivered is viscous.

[0045] While drive module 110 includes a canister and puncture mechanism as a source of pressurized gas, it will be appreciated that drive module 110 may include other sources of pressurized gas that may be actuated to release pressurized gas into second chamber 126, i.e., around and / or within chamber 156 of plunger 150, to advance plunger 150 with minimal drop in force. For example, an external canister or gas source may be connected to drive module 110 prior to use, and the gas canister may include features other than a septum and puncture pin for releasing gas from the canister.

[0046] While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail, It is to be understood, however, that the invention is not limited to the specific forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. 1. A drive module for an infusion device for delivering one or more medications into a body of a subject, comprising: an elongated drive housing including a first end and a second end and a chamber; a source of pressurized gas in communication with a passageway into the chamber; a plunger slidably disposed within the chamber, the plunger including a proximal end and a distal end including a piston, wherein gas entering the chamber from the passageway is configured to move the plunger from an initial position to an extended position, wherein the distal end of the plunger extends from the second end of the drive housing for delivering one or more medicaments from the injector module based on movement of the plunger; the piston including one or more passages configured to allow gas from a canister entering the chamber to pass through the piston and into the chamber around the plunger.

2. 2. The drive module of claim 1, The drive module of claim 1, wherein the plunger includes a plunger chamber extending from an opening at a proximal end communicating with a second opening, and pressurized gas from a canister entering the chamber fills the plunger chamber.

3. 2. The drive module of claim 1, a drive module further comprising an actuator for opening a path from the pressurized gas source through the passageway into the chamber;

4. The drive module according to any one of claims 1 to 3, the pressurized gas source a lancing mechanism having a pin holder containing a lancing pin within the drive housing adjacent the first end; a canister containing pressurized gas, the canister including a pierceable septum disposed adjacent to the piercing pin, the pin holder being movable between an inactivated position in which the piercing pin is spaced from the septum and an activated position in which the piercing pin pierces the septum to allow gas within the canister to flow through the passageway and into the second chamber; an actuator for guiding the pin holder from an inactive position to an active position.

5. 5. The drive module of claim 4, The actuator one or more catches on the drive housing adjacent the pin holder for restraining the pin holder in an inoperative position; a drive module comprising: an actuation sleeve slidably disposed in the drive housing and including a proximal end disposed distal to the one or more catches, wherein proximal movement of the actuation sleeve disengages the one or more catches, thereby automatically moving the pin holder from a non-actuated position to an actuated position to actuate the drive module.

6. 5. The drive module of claim 4, the pin holder includes a lead screw having threads that cooperate with a first end of the drive housing, and rotation of the lead screw moves the lead screw from an inactive position to an active position.

7. 7. The drive module of claim 6, the actuator includes a rotary handle attached to a first end of the drive housing and coupled to the lead screw, the handle rotatable relative to the drive housing to move the lead screw from an inactive position to an active position.

8. 5. The drive module of claim 4, 10. A drive module comprising: an actuator including a handle pivotally coupled to the drive housing; and a link bar coupled between the handle and the pin holder, wherein rotation of the handle about a pivot causes the link bar to guide the pin holder from an inactive position to an active position.

9. 5. The drive module of claim 4, The drive module, characterized in that the actuator includes an actuation button extending from the drive housing and coupled to the pin holder, the actuation button being advanceable to direct the pin holder distally a distance sufficient to move the pin holder from an inactivated position to an activated position.

10. 5. The drive module of claim 4, A drive module characterized in that the partition of the canister is oriented proximally within the drive housing, the puncture mechanism is positioned proximal to the canister, the puncture pin faces distally toward the partition, and distal movement of the pin holder moves the puncture pin distally to penetrate the partition.

11. 5. The drive module of claim 4, A drive module characterized in that the partition of the canister is oriented distally within the drive housing, the puncture mechanism is positioned distal to the canister, the puncture pin faces proximally toward the partition, and proximal movement of the pin holder moves the puncture pin proximally to penetrate the partition.

12. 1. A device for delivering one or more drugs into a patient's body, comprising: a) a drive module according to any one of the preceding claims; b) an injector module, said injector module comprising: an injector housing coupled to the drive housing and holding a medicament chamber containing one or more medicaments; an injector piston slidably disposed within the medication chamber and coupled to a distal end of the plunger; a needle extending from the injector module opposite the drive housing, the needle communicating with the drug chamber for delivering one or more drugs from the drug chamber when the plunger moves from a retracted position to an extended position to advance the piston within the drug chamber.

13. 1. A device for delivering one or more drugs into a patient's body, comprising: a drive module and an injector module; a) the drive module: an elongated drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end through an intermediate passage; a puncture mechanism in the first chamber adjacent the first end, the puncture mechanism including a puncture pin; a canister containing pressurized gas, the canister including a pierceable septum disposed adjacent to the puncture pin; an actuator configured to move one of the puncture mechanism and the canister to cause the puncture pin to pierce the septum and allow gas within the canister to flow through the first chamber around the canister and further through the intermediate passage into the second chamber; a plunger slidably disposed within the second chamber, the plunger including a proximal end including a piston and a distal end, wherein gas entering the second chamber from a passageway is configured to move the plunger from an initial position to an extended position, wherein the distal end of the plunger extends from the second end of the drive housing for delivering one or more medicaments from the injector module upon movement of the plunger; b) the injector module comprises: an injector housing coupled to the drive housing and holding a medicament chamber containing one or more medicaments; a piston slidably disposed within the medication chamber and coupled to a distal end of the plunger; a needle extending from the injector module opposite the drive housing, the needle communicating with the medicament chamber for delivering one or more medicaments from the medicament chamber when the plunger moves from a retracted position to an extended position to advance the piston within the medicament chamber; the piston including one or more passages configured to allow gas from the canister entering the first chamber to pass through the piston and into the chamber around the plunger.

14. 14. The device of claim 13, 10. A device comprising: a plunger having a plunger chamber extending from an opening at a proximal end communicating with a second chamber; and pressurized gas from the canister entering the second chamber fills the plunger chamber.

15. 14. The device of claim 13, The device further comprises a needle guard, the needle guard being movable between a protective position that covers the needle and a retracted position that exposes the needle for injection, the needle guard being coupled to the actuator and slidable along the drive housing such that when guided to the retracted position, the needle guard activates the actuator.

16. 16. The device of claim 15, The device wherein the needle guard is biased to a protective position.

17. 17. The device of claim 16, an actuation sleeve slidably disposed in the drive housing and coupled to the needle guard; a spring coupled between the actuation sleeve and the drive housing to bias the needle guard to a protective position.

18. 14. The device of claim 13, The device, characterized in that the puncture mechanism comprises a pin sleeve slidably positioned within the first chamber adjacent the first end and carrying the puncture pin, the pin sleeve being movable between an inactivated position in which the puncture pin is spaced from the septum and an activated position in which the puncture pin penetrates the septum, the pin sleeve being biased to the activated position and restrained in the inactivated position by the actuator.

19. 20. The device of claim 18, The device is characterized in that the actuator includes one or more catches on the drive housing that restrain the pin sleeve in an inoperative position, and the actuation sleeve is configured to disengage from the one or more catches to allow the pin sleeve to automatically move from the inoperative position to the actuated position.

20. 17. The device according to claim 15 or 16, The device further includes a locking mechanism for preventing proximal movement of the needle guard from its protective position until the locking mechanism is released.

21. The device according to any one of claims 13 to 19, The device, wherein the syringe housing includes a window that allows observation of the piston within the medication chamber.

22. The device according to any one of claims 13 to 19, The device, characterized in that the puncture mechanism comprises a sleeve slidably positioned within the first chamber adjacent the first end and carrying the puncture pin, the sleeve being movable between an inactivated position in which the puncture pin is spaced from the septum and an activated position in which the puncture pin penetrates the septum, the sleeve being biased to the activated position and restrained in the inactivated position by the actuator.

23. The device according to any one of claims 13 to 19, The device, wherein the injector module further includes a syringe mounted within the injector housing, the syringe including a barrel defining the medication chamber, the needle extending from a distal end of the syringe, and the piston being slidable within the barrel.

24. 24. The device of claim 23, A device, wherein one or both of the syringe and the injector housing include one or more connectors for securing the syringe within the injector housing.

25. 25. The device of claim 24, The device is characterized in that the injector housing has a proximal end connectable to the distal end of the drive module and defines an opening for introducing the syringe therein and engaging the one or more connectors prior to connecting the injector housing to the drive module.

26. 25. The device of claim 24, The device further comprising a plunger adapter coupling a distal end of the plunger to the piston for moving the piston in direct response to movement of the plunger.

27. 25. The device of claim 24, The device wherein the injector housing includes one or more windows for viewing the syringe during operation of the device.

28. 14. The device of claim 13, The device, characterized in that the puncture mechanism includes a pin holder slidably positioned within the first chamber adjacent the first end and carrying the puncture pin, the pin holder being movable between an inactivated position in which the puncture pin is spaced from the septum and an activated position in which the puncture pin penetrates the septum, and the actuator is coupled to the pin holder to move the pin holder from the inactivated position to the activated position.

29. 29. The device of claim 28, the pin holder includes a lead screw having threads that cooperate with a first end of the drive housing, and rotation of the lead screw moves the lead screw from an inactive position to an active position.

30. 30. The device of claim 29, a rotation handle attached to a first end of the drive housing and coupled to the lead screw, the handle rotatable relative to the drive housing to bring the lead screw from an inactive position to an active position.

31. 30. The device of claim 29, the actuator comprising a handle pivotally coupled to the drive housing and a link bar coupled between the handle and the pin holder, wherein rotation of the handle about a pivot causes the link bar to guide the pin holder from an inactive position to an active position.

32. 29. The device of claim 28, The device, characterized in that the actuator includes an actuation button extending from the drive housing and coupled to the pin holder, the actuation button being advanceable to direct the pin holder distally a distance sufficient to move the pin holder from an inactivated position to an activated position.

33. 29. The device of claim 28, a septum of the canister facing proximally within the first chamber, the puncture mechanism being positioned proximal to the canister, the puncture pin facing distally toward the septum, and distal movement of the pin holder causing the puncture pin to move distally and penetrate the septum.

34. 14. The device of claim 13, A device characterized in that the partition of the canister is oriented distally within the first chamber, the puncture mechanism is positioned distally of the canister within the first chamber, and the puncture pin is oriented proximally toward the partition.

35. 35. The device of claim 34, The device, wherein the actuator is configured to move the canister distally within the first chamber to cause the puncture pin to penetrate the septum.

36. 1. A drive module for an infusion device for delivering one or more medications into a body of a subject, comprising: an elongated drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end through an intermediate passage; a puncturing mechanism including a puncturing pin within the first chamber; a canister containing pressurized gas, the canister including a pierceable septum disposed adjacent to the piercing pin, wherein one or both of the canister and the piercing mechanism are movable between an inactivated position in which the piercing pin is spaced from the septum and an activated position in which the piercing pin pierces the septum to allow gas within the canister to flow into the second chamber through the first chamber and the intermediate passage; a plunger slidably disposed within the second chamber, the plunger including a proximal end including a piston and a distal end, wherein gas entering the second chamber is configured to move the plunger from an initial position to an extended position, wherein the distal end of the plunger extends from the second end of the drive housing for delivering one or more medicaments from the injector module based on movement of the plunger; the piston including one or more passages configured to allow gas from the canister entering the second chamber to pass through the piston and into the second chamber around the plunger.

37. 37. The drive module of claim 36, The drive module of claim 1, wherein the plunger includes a plunger chamber extending from an opening at a proximal end that communicates with the second chamber, and wherein pressurized gas from the canister entering the second chamber fills the plunger chamber.

38. 38. The drive module of claim 37, The drive module further includes an actuator for bringing one or both of the lancing mechanism and the canister from an inactivated position to an activated position.

39. 1. A device for delivering one or more drugs into a patient's body, comprising: a) a drive module according to any one of claims 36 to 38; b) an injector module, said injector module comprising: an injector housing coupled to the drive housing and holding a medicament chamber containing one or more medicaments; an injector piston slidably disposed within the medication chamber and coupled to a distal end of the plunger; a needle extending from the injector module opposite the drive housing, the needle communicating with the drug chamber for delivering one or more drugs from the drug chamber when the plunger moves from a retracted position to an extended position to advance the piston within the drug chamber.

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