Patent Application
20230119081
The present application relates generally to devices and methods for delivering agents into a subject’s body and, more particularly, to auto-injectors and/or gas-powered drive systems for injection devices, and to methods for making and using such devices.
There are many applications involving delivery of a medicament or other agent subcutaneously, intramuscularly, or otherwise into a patient’s body. For example, auto-injectors are available that include a predetermined dose of the agent that may be delivered automatically into the patient’s body, e.g., after placement against the patient’s skin and activation. Generally, such auto-injectors are spring-loaded syringes that are activated to release the spring, which generates sufficient force to penetrate the skin with a needle and deliver the dose within the syringe. For viscous fluids, the forces required to develop fluid flow can be higher than spring-powered systems can provide. When springs can be used, they must generate a relatively high force that requires springs of high mass. Consequently, such auto-injectors may make substantial noise, create pressure spikes in the syringe leading to glass breakage, vibrate, and/or may drive the needle forcefully into the patient’s skin, which may cause pain and/or may startle the user, particularly when the patient is administering the injection themselves.
Therefore, improved devices and methods for delivering agents into a patient’s body would be useful.
The present application relates generally to devices and methods for delivering agents into a subject’s body and, more particularly, to auto-injectors and/or gas-powered drive systems for injection devices, and to methods for making and using such devices.
In accordance with one example, a drive module is provided for an injection device for delivering one or more agents into a subject’s body that includes an elongate drive housing including a first end and a second end, and a chamber; a source of pressurized gas communicating with a passage into the chamber; a plunger slidably disposed within the chamber comprising a proximal end including a piston and a distal end, the plunger configured such that gas entering the chamber from the passage causes the plunger to move 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 agents from an injector module based on movement of the plunger, wherein the piston comprises one or more passages configured to allow gas from the canister entering the chamber to pass through the piston into the chamber around the plunger. Optionally, the plunger may include a plunger chamber extending from an opening in the proximal end communicating with the second such that pressurized gas from the canister entering the chamber fills the plunger chamber.
In accordance with another example, a device is provided for delivering one or more agents into a patient’s body that includes a) a drive module including an elongate 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 via an intermediate passage; a puncture mechanism within the first chamber adjacent the first end including a puncture pin; a canister containing pressurized gas including a penetrable septum disposed adjacent the puncture pin; an actuator configured to move one of the puncture mechanism and the canister to cause the puncture pin to penetrate the septum and cause the gas within the canister to flow through the first chamber around the canister, through the intermediate passage, and into the second chamber; and a plunger slidably disposed within the second chamber comprising a proximal end including a piston and a distal end, the plunger configured such that gas entering the second chamber from the passage causes the plunger to move 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 agents from an injector module based on movement of the plunger. The device also includes an injector module including an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents; a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger; and a needle extending from the injector module opposite the drive housing and communicating with the agent chamber for delivering the one or more agents from the agent chamber when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber, wherein the piston comprises one or more passages configured to allow gas from the canister entering the first chamber to pass through the piston into the chamber around the plunger.
The devices herein may be used to perform an injection, e.g., a method including inserting the needle through a patient’s skin; and activating an actuator to deliver pressurized gas from the source through the passage into the chamber, thereby moving the plunger from the initial position to the extended position and, consequently, advancing the piston within the agent chamber to deliver the one or more agents through the needle into the patient’s body.
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features and design elements of the drawings are not to-scale. On the contrary, the dimensions of the various features and design elements are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures.
Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill 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 potential and exemplary methods and materials are now described.
It must 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, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.
Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.
Turning to the drawings,
Generally, the drive module 10 includes an elongate drive housing 12 containing a puncture mechanism 30 including a puncture pin 34, a gas canister or other source of pressurized gas 40, and a plunger 50. The housing 12 includes an enclosed first or proximal end 14 and an open second or distal end 16 aligned along a longitudinal axis 18. The housing 12 may be formed as a single, integral component, e.g., from metal, such as steel, aluminum, and the like, plastic, and/or composite material, by one or more of cold drawing, molding, casting, machining, and the like. Alternatively, the housing 12 may be formed from multiple, separate components that are substantially permanently attached together, e.g., by one or more of welding, soldering, fusing, bonding with adhesive, interference fit, and the like.
The housing 12 includes a first or proximal portion 20 adjacent the first end 14 defining a first chamber 22 for receiving the canister 40 and puncture mechanism 30, and a second or distal portion 24 adjacent the second end 16 defining a second chamber 26 communicating with the first chamber 22 via an intermediate passage 28. Both housing portions 20, 24 may have a generally cylindrical or other appropriate shape, e.g., defining a substantially uniform outer and/or inner diameter.
As shown, the puncture mechanism 30 may be provided within the first chamber 22 adjacent the intermediate passage 28 and the canister 40 may be located proximal to the puncture mechanism 30 with a septum 44 of the canister 40 spaced apart initially from the puncture pin 34. Alternatively, the puncture mechanism 30 may be provided 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 the puncture mechanism 30, e.g., again with the puncture pin 34 initially spaced apart from the septum 44.
Generally, with particular reference to
In the example shown in
The pin sleeve 32 may be biased to the active position and restrained in the inactive position, e.g., by one or more catches 36 on the drive housing 12 restraining the pin sleeve 32 in the inactive position. For example, a compression spring 38 may be disposed around the pin sleeve 32 and/or otherwise coupled between the housing 12 and the pin sleeve 32 to direct the pin sleeve 32 from the inactive position to the active position when activated.
For example, as shown in
When the septum 46 is penetrated, gas within the cavity 48 is released into the first chamber 22, e.g., such that the gas travels distally around the canister 40, through the intermediate passage 28, and into the second chamber 26. For example, the drive housing 12 and canister body 42 may have corresponding diameters to provide sufficient clearance to allow the gas to travel distally around the canister 40 within the first chamber 22 and enter the intermediate passage 28, as described elsewhere herein.
Optionally, the intermediate passage 28 may have a relatively small diameter to provide a restrictor to reduce the pressure rise time. Alternatively, a precision orifice (not shown) may be inserted between the first and second chambers 22, 26, if desired to act as a restrictor. For example, an orifice may i) slow down the transient flow of gas, slowing the rise of pressure imparted to the plunger 50, e.g., providing a soft-start to the injection, reducing/eliminating pressure shock waves in the fluid to be injected in the syringe and possibly reducing patient pain as the drug injection is gently initiated; and/or ii) slow down the steady state flow of gas, reducing the otherwise pressure imparted to the plunger 50, providing a limiting effect to the flow rate of the drug injected into the patient.
Returning to
Generally, the syringe 70 includes a barrel 74 and a piston or stopper 76 slidably disposed therein to enclose the agent chamber 72. A needle 78 may extend from a closed distal end 74a of the barrel 74. In one example, the syringe 70 may be a pre-filled syringe, e.g., formed from glass, plastic, and the like, filled with a predetermined volume of agent, e.g., corresponding to a single dose for a patient. The agent chamber 72 may include one or more therapeutic and/or diagnostic agents, e.g., a viscous fluid having a viscosity greater than water, e.g., between about one and two thousand centipoise (1.0-2000 cP), e.g., including large proteins and/or other medicaments that require substantial force and/or time to deliver.
Optionally, one or more flanges or other features 75 may be provided on a proximal end 74b of the barrel 74 that may engage one or more detents, ridges, or other features (not shown) within the injector housing 62. For example, during manufacturing or assembly, a syringe 70 may be selected that may be inserted into the interior 64 through the proximal end 62a of the injector housing 62, e.g., until the needle 78 extends partially through the distal end 62b and the flange 75 on the syringe 70 is captured by the feature(s) on 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 encapsulate the components and provide the injector device 8 ready for use.
Alternatively, the injector module 60 may include an integral barrel (not shown) defining the agent chamber 72 and carrying the needle 78. For example, the injector housing 62 may define a substantially enclosed agent chamber (not shown) that slidably receives the piston 76 and includes a needle 78 permanently mounted to the injector housing 62 for delivering the agent within the agent chamber 72. In a further alternative, the syringe 70 (or injector housing 62 with integral agent chamber) may include a distal port (not shown) without a needle, such that a separate needle (also not shown) may be coupled to the port, e.g., using a Luer fitting, mating threads, and/or other cooperating connectors, immediately before an injection or otherwise as desired.
The piston 76 may be coupled to the distal end 54 of the plunger 50, e.g., during assembly of the injector housing 62 to the outer sleeve 66, such that subsequent advancement of the plunger 50 causes the piston 76 to advance within the agent chamber 72 to direct the one or more agents through the needle 78 into a patient’s body, e.g., automatically upon activation of the puncture mechanism 30, as described further elsewhere herein. Optionally, a plunger adapter 58 may be provided that may provide an interface between the distal end 54 of the plunger 50 and the piston 76, e.g., to provide connectors therebetween and/or ensure proper spacing such that the piston 76 is advanced in conjunction with the plunger 50.
The plunger 50 may be an elongate rod or other member including a proximal end 52 and a distal end 54 that is slidably disposed within the second chamber 26 such that the plunger 50 that is movable from an initial or retracted position (e.g., shown in
During use, the drive module 10 may be coupled to an injector module or other delivery device (or already integrated into such a device), and used to deliver one or more agents within an agent housing of the delivery device (not shown). For example, the injector module may house a syringe including an injection piston in its proximal end and a needle on its distal end and containing a preset volume of agent for delivery, similar to the devices disclosed in U.S. Pat. No. 11,071,824.
Once the delivery device is positioned as desired, e.g., inserting the needle into a target location of the subject’s body, an actuator of the delivery device may be activated to cause the puncture pin 34 to penetrate the septum 44 of the canister 40, thereby causing pressurized gas from the canister 40 to pass through the first chamber 22 and intermediate passage 28 into the second chamber 26. The resulting pressure applies a distal force to the piston 53, causing the plunger 50 to advance from the initial position (
As can be noted from
Turning to
The puncture mechanism 30 and canister 40 may be provided within the first chamber 122 adjacent the intermediate passage 128 with the septum 44 of the canister 40 spaced apart initially from the puncture pin 34, e.g., oriented distally as shown or oriented proximally (not shown), also similar to the drive module 10. An actuator may be provided that may move one or both of the puncture mechanism 30 and/or canister 40 to cause the puncture pin 34 to penetrate the septum 44 and release the gas, similar to the drive module 10 and the devices disclosed in U.S. Pat. No. 11,071,824, incorporated by reference herein.
The plunger 150 may be an elongate rod or other member including a proximal end 152 and a distal end 154 that is slidably disposed within the second chamber 126 such that the plunger 150 is movable from an initial or retracted position (e.g., shown in
Unlike the drive module 10, however the plunger 150 includes a piston 153 on the proximal end 152 that includes one or more passages 153a that extend between proximal and distal surfaces of the piston 153. For example, the piston 153 may include a plurality of circular or other enclosed passages 153a spaced apart from one another around a circumference of the piston 153. Alternatively, the passage(s) may be grooves formed in the outer surface of the piston 153 (not shown) that extend between the proximal and distal surfaces. The piston 153 may be sized and/or shaped to slidably engage a wall of the second chamber 126, e.g., to allow the plunger 150 to move from the initial to the extended position, but does not require O-rings or other seals. For example, the piston 153 may be a cylindrical head having a larger outer diameter than the plunger 150 that is integrally molded or otherwise formed with the plunger 150, or that is manufactured separately and permanently attached to the plunger 150.
As can be seen in
Optionally, the plunger 150 may also include a plunger chamber 156, e.g., extending from the open proximal end 152 of the plunger 150 to the closed distal end 154. Consequently, when the septum 44 of the canister 40 is initially penetrated, gas within the canister 40 may pass freely from the first chamber 122 through the intermediate passage 128 and into the second chamber 126, i.e., through the passage(s) 153a into the second chamber 126 around the plunger 150 and into the plunger chamber 156, as described further below.
During use, the drive module 110 may be coupled to an injector module or other delivery device (or already integrated into such a device) and used to deliver one or more agents within an agent housing of the delivery device (not shown). For example, the drive module may be coupled to an injector module housing a syringe including a piston in its proximal end and a needle on its distal end and containing a preset volume of agent for delivery, similar to the devices disclosed in U.S. Pat. No. 11,071,824.
Once the delivery device is positioned as desired, e.g., after inserting the needle into a target location of a subject’s body (or placing the auto-injector against the skin), an actuator the of the delivery device may be activated to cause the puncture pin 34 to penetrate the septum 44 of the canister 40, thereby causing pressurized gas from the canister 40 to pass through the first chamber 122 and intermediate passage 128 into the second chamber 126. As with the drive module 10, the resulting pressure applies a distal force to the plunger 150, causing the plunger 150 to advance from the initial position (
However, as can be noted from
Although the drive module 110 includes a canister and puncture mechanism as the source of pressurized gas, it will be appreciated that the drive module 110 may include other sources of pressurized gas that may be actuated to release the pressurized gas into the second chamber 126, i.e., around and/or into the chamber 156 of the plunger 150, to advance the plunger 150 with minimized force drop. For example, an external canister or gas source may be connected to the drive module 110 before use, or the gas canister may include arrangements other than a septum and puncture pin to release the gas from the canister.
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 should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
The present application claims benefit of co-pending U.S. Provisional Application Serial No. 63/255,884, filed Oct. 14, 2021, the entire disclosure of which is expressly incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63255884 | Oct 2021 | US |
