HK1149516B - Needle-free injection device with nozzle auto-disable - Google Patents

Description

Needleless injection device with self-disabled nozzle

Cross Reference to Related Applications

This application is related to U.S. patent application "NEEDLE-FREE INJETION DEVICE WITH AUTO-DISABLE (self-disabling needleless injection device)" filed on 26.11.2007, the disclosure of which is incorporated herein by reference.

Background

Needleless injection systems provide an alternative to standard fluid delivery systems, which typically use a needle adapted to pierce the outer surface of a subject. Typically, needleless injection systems are designed to eject fluid from the fluid chamber with sufficient pressure to allow the fluid to penetrate the target to the desired extent. For example, common applications for needle-free injection systems include delivering intradermal, subcutaneous, and intramuscular injections to or through the skin of a subject. For each of these applications, the fluid must be ejected from the system with sufficient pressure to enable the fluid to penetrate the tough outer dermal layer of the recipient's skin.

Examples of needleless injection systems and components can be found in the following documents: U.S. patents 4,592,742, 4,596,556, 4,790,824, 4,940,460, 4,941,880, 5,062,830, 5,064,413, 5,312,335, 5,312,577, 5,383,851, 5,399,163, 5,503,627, 5,505,697, 5,520,639, 5,746,714, 5,782,802, 5,893,397, 5,993,412, 6,096,002, 6,132,395, 6,216,493, 6,264,629, 6,319,224, 6,383, 168, 6,415,631, 6,471,669, 6,506,177, 6,572,581, 6,585,685, 6,607,510, 6,641,554, 6,645,170, 6,648,850, 6,623,446, 6,676,630, 6,689,0936,709,427, 6,716,190, 6,752,780, 6,752,781, 6,783,509, 6,935,384, 6,942,645, 6,979,310, 6,981,961, 7,056,300, and 7,156,823; U.S. patent application publications 2005/0119608 and 2006/0189927; and international publication WO 00/72908, the disclosure of which is incorporated herein by reference in its entirety and for all purposes.

Disclosure of Invention

The present disclosure relates to a nozzle assembly for a needle-free injection device. The disclosed nozzle assembly includes a nozzle body including an injection chamber and one or more outlet orifices, and a plunger configured to move through the injection chamber toward the one or more outlet orifices. In some embodiments, the plunger includes a first portion and a second portion removably joined by a frangible region. In some embodiments, the plunger includes a deformable extension configured to selectively couple the plunger to a drive assembly of a needle-free injection device.

The advantages of the disclosed nozzle assembly may be more readily understood after a consideration of the drawings and the detailed description.

Drawings

Fig. 1 is a cross-sectional view of an example of a nozzle assembly coupled to an example of a needle-free injection device having a delivery system and an actuation system.

Fig. 2 shows a nozzle assembly coupled to a delivery system of a needle-free injection device, the nozzle assembly including a nozzle body and a plunger.

Figure 3 shows the nozzle assembly of figure 2 retracted by the delivery system to draw a dose of injectate into the nozzle assembly.

FIG. 4 shows the nozzle assembly of FIG. 3 after delivery of an injection, wherein the plunger breaks through along the frangible region leaving a portion of the plunger in the nozzle body.

Fig. 5 shows an example of a frangible region of the plunger.

Fig. 6 illustrates an example of a nozzle assembly including an intradermal nozzle assembly and a vial adapter.

Fig. 7 shows a cross-sectional view of the intradermal nozzle assembly.

FIG. 8 illustrates a nozzle assembly including a plunger having an extension to couple the plunger to a ram of a delivery system; the ram includes an arcuate portion.

FIG. 9 illustrates a nozzle assembly including a plunger having an extension to couple the plunger to a ram of a delivery system; the ram includes a cutting portion.

Fig. 10 shows the nozzle assembly of fig. 9 with the extension deformed outwardly from the ram.

FIG. 11 illustrates a nozzle assembly including a plunger having an extension to couple the plunger to a ram of a delivery system; the ram includes an inclined portion.

Fig. 12 shows the nozzle assembly of fig. 11 with the extension deformed outwardly from the ram.

Detailed Description

Fig. 1 shows an example of a needle-free injection device 10 and a nozzle assembly 100. Although the disclosed injection device is reusable, the nozzle assembly includes various self-disabling features to inhibit reuse of the nozzle assembly. For example, the nozzle may be replaced after each injection or after multiple injections.

The device 10 includes a body 12 to enclose various systems for performing injections. The body is generally sized and shaped to grip comfortably in a user's hand and may take any suitable configuration. Body 12 may be formed from injection molded plastic, although various other materials and manufacturing methods are suitable.

As shown in fig. 1, the body 12 may include various sub-portions, such as housings 14, 16. The housings may be configured to move relative to each other to actuate various systems. In the example shown in fig. 1, one or more of the housings may be rotatable relative to the other housing and/or about a central axis 18 to actuate various components of the device.

The body includes an opening 20 at the end of the device to receive a nozzle assembly. The body may include other apertures, such as one or more viewing ports, to provide feedback or indication to the user of the device. The aperture may be aligned with indicia, such as an arrow or text, that indicates proper operation of the device by the user or communicates information to the user, such as the current configuration or state of the device.

The nozzle assembly 100 is configured to be selectively coupled to a delivery system. The nozzle assembly surrounds the injectate and provides an interface with the skin of the recipient. As shown in fig. 1-4, the nozzle assembly 100 includes a nozzle body 110 that forms an injection chamber 112 having one or more outlet orifices 114. The nozzle assembly also includes a plunger 116 configured to move through the injection chamber toward the bore to expel the injectant.

The device 10 may include one or more systems and perform injections. For example, the device of fig. 1 includes a delivery system 22 and an actuation system 24. The delivery system 22 provides a contact surface for delivering injectate to a subject and delivers the injectate by expelling the injectate from the device. The delivery system 22 is configured to expel a quantity of fluid, such as a medicament, from the device. The word "medicament" as used herein is intended to include, by way of example and not limitation, any drug, medicine, therapeutic agent, vaccine, cosmetic or other material capable of being administered by injection. An actuation system 24 prepares the device for delivery of an injection and actuates delivery of the injection.

The delivery system 22 includes a drive assembly 26 to provide a driving force to perform the injection. In some versions of the device, a transmission assembly 28 may be provided to couple the nozzle assembly and the drive assembly.

Actuation system 24 includes a priming assembly 30 (e.g., a tensioner) to selectively position the drive assembly to provide a driving force to deliver an injection. The trigger assembly 32 assists the user in selectively actuating the drive assembly to deliver an injection, either directly or indirectly through the transmission assembly.

The structure and operation of a needleless INJECTION device configured to receive the nozzle assembly 100 can include those disclosed in U.S. published patent application 2005/0119608 and related U.S. patent application "NEEDLE-FREE INJECTION DEVICE WITH AUTO-DISABLE", filed on 26.11.2007. In the illustrative arrangement shown in fig. 1, the drive assembly 26 includes a drive source 40 (e.g., a spring) that is disposed between spring stop members 42, 44 such that the spring stop members are closer together compressing the spring, while decompression of the spring urges the stop members away from each other. Relative rotation between the housing portions (e.g., rotation of the housing 16 relative to the housing 14) actuates the tightener 30, which causes the distal spring stop to move toward the proximal spring stop to compress the spring. When the spring is compressed, the device is said to be in a tightened configuration. In the example of fig. 1, the tightener 30 is rotated in a first direction and acts on the inner tightening core 46 to move the screw 48 relative to the tightening core, thereby moving the distal spring stop to the left.

As also shown in fig. 1, the nozzle assembly 100 may be coupled to the device by placing the nozzle assembly in the device through the opening 20, such as by inserting the nozzle assembly along the axis 18. The nozzle body may include one or more guides 118, as shown in fig. 2-4 and 6, to assist the user in positioning the nozzle assembly relative to the device. The guide and opening may be similarly shaped to assist the user in aligning the nozzle assembly. For example, as shown in fig. 6, the nozzle body may be configured to be inserted into the device and then rotated to lock the guide into the device.

In the example shown in fig. 1, insertion of the nozzle assembly changes the configuration of the device so that an injection can be made. Thus, the device is disabled (i.e., prevented from releasing the spring) until the nozzle assembly is engaged. For example, the nozzle assembly of fig. 1 moves the drive assembly 28 (e.g., in the form of a ram 50 extending along the central axis of the device) to the right, which allows the one or more locking members 52 to engage the ram, thereby coupling the actuation system to the delivery system. Because the rearward movement of the ram engages the proximal spring stop, the spring stop members are then interconnected and ready to be retracted relative to the housing 14 to withdraw the ram and plunger, thereby drawing a dose of injectate into the nozzle body.

The rear housing 16 is rotatable in a second direction (opposite the first direction during spring compression) to withdraw the plunger and the two spring stop members (to the right with respect to fig. 1). As shown in fig. 1, movement of the plunger to the right draws the injectate into the chamber 112 through the orifice 114. During a metered injection, the housings 14 and 16 may translate relative to one another as desired.

To deliver the injection, a trigger assembly 32 (e.g., in the form of a button) is actuated to push the ram and plunger toward the exit orifice(s). For example, when the trigger assembly of fig. 1 is depressed, the bushing 54 is pushed towards the exit aperture and provides a recess to receive the locking member 52. The ram is thus free to travel through the device. Because the distal spring stop remains in place, the decompression of the spring pushes the proximal spring stop member toward the exit orifice(s), which moves the ram and plunger toward the orifice(s) to deliver the injection.

In the example shown in fig. 1-4, the nozzle plunger 116 includes a first portion 120 and a second portion 122 coupled together by a frangible region 124. The first portion 120 may be referred to as a proximal portion because it is closest to the outlet orifice. The second portion 122 may be referred to as a distal portion or base because it is farther from the exit orifice. The proximal portion may be configured to break away from the distal portion along the frangible region and embed into the proximal end of the injection chamber, thereby preventing the injectate from entering the nozzle body. For example, to inhibit reuse of the nozzle assembly, the proximal end portion may be retained in the injection chamber, for example in the lead-in portion 126 proximate the bore, with the distal end portion of the plunger retracted from the injection chamber.

The frangible region may be configured to be generated in response to a force applied along a longitudinal axis of the plunger (along the central axis 18, as shown in fig. 1). For example, ram 50 can include impact region 60 to apply a suitable force to the frangible region when triggering an injection. As illustrated in FIG. 1, delivery of the injectate is completed when the ram 50 moves toward the exit orifice(s) 114. Continued force of the impact region 60 against the plunger may push the distal portion 122 of the plunger forward. However, because the proximal portion 120 is prevented from further movement by the interior of the nozzle body (e.g., the lead-in portion 126), the frangible region breaks, as shown in FIG. 4. The proximal portion may become embedded in the nozzle body to prevent reuse of the nozzle assembly. Further, because there is no contact between the injectate and the distal portion, the distal portion can be removed from the ram without requiring the user to contact the injectate.

Fig. 4 and 5 show an example of the frangible region 124 after the proximal portion has been separated from the distal portion of the plunger. As shown, the frangible region includes a finger 128 that disengages from, for example, a post 130 to separate the plunger portions.

As shown in fig. 1-4 and 6, the plunger may be at least partially visible through the nozzle body. The plunger may include first and second visually distinct regions such that movement of the plunger through the nozzle body may be measured. For example, the proximal portion 120 may include an overmolded tip 132 (best seen in fig. 1) such that the tip is visibly distinguished from the remainder of the proximal portion. In another configuration, the proximal portion is visually distinguishable from the distal portion. The injection chamber 112 may include a dose scale 140, as shown in fig. 6, to incrementally measure the injection dose drawn into the chamber. In some versions of the device, the dose scale includes markings, and the first and second visually distinct regions of the plunger are configured to align with the markings. Additionally or alternatively, the dose scale may be a pre-moulded dose scale having a rib to indicate each measuring unit.

Fig. 6 also shows a nozzle assembly 100 suitable for delivering an intradermal injection. The intradermal nozzle assembly may include a number of outlet orifices 114. For example, the nozzle assembly may include three orifices arranged in a triangular configuration, four orifices arranged in a square configuration, and so forth. The exit orifice may be laser drilled to produce an orifice diameter smaller than that provided by typical nozzle assemblies. For example, the exit orifice may have a diameter equal to or less than 0.003 inches. The outlet holes may be formed using the methods described in U.S. patent application No.11/765,245, the disclosure of which is incorporated herein by reference.

As shown in fig. 6 and 7, the plunger 116 includes a proximal portion 120 and a distal portion 122 having different diameters. For example, the distal portion may have a diameter that is greater than the diameter of the proximal portion. The small diameter portion acts as a pressure multiplier and allows greater dose accuracy, for example for intradermal doses of 50 to 150 μ L. For example, reducing the plunger diameter while maintaining the spring force increases the pressure used to deliver the injection without changing the ram and plunger travel length. Thus, the multi-orifice nozzle provides increased delivery pressure with the same device in combination with a small plunger diameter. For example, the device disclosed in fig. 1 may be coupled to a nozzle assembly having a distal plunger portion with a diameter adapted to couple with the drive assembly 28 and a proximal plunger portion with a diameter adapted to deliver injections at different tissue depths. The device and corresponding spring 40 and spring travel length may be used with a nozzle assembly having a proximal plunger diameter suitable for delivering intradermal, subcutaneous and intramuscular injections. A smaller plunger diameter enables a wider range of materials from which the plunger 116 may be formed. For example, as previously described, by using different plunger materials, the plunger may provide first and second visually distinct regions, making it easier to measure the movement of the plunger through the nozzle body, thereby providing greater dose accuracy. The two diameter plungers may be formed of different materials such that each diameter is formed of a different color plastic resin. For example, the plunger may be formed as a single piece in an injection molding machine using an "overmolding" or "overmolding" process such that a portion of the plunger is a different color than the remainder of the plunger.

The nozzle assembly may include a tension ring 150 to maintain skin tension of the subject during the injection process. Vial adapter 160 may engage the nozzle body to couple the nozzle assembly to a vial of injectate during dosing of the nozzle assembly. The vial adapter may be coupled to the porous nozzle using a luer taper engagement.

Another method of preventing reuse of the nozzle assembly is by providing a nozzle assembly with a self-disabling feature that prevents the plunger and ram from being coupled together after an injection is made. For example, a portion of the plunger may be deformable to prevent coupling of the plunger with the ram after delivery of an injection. In the following example, the nozzle assembly is coupled to the device such that the plunger is coupled to the drive assembly, such as by snapping onto the ram. The device may then be surrounded (surround), fitted (armed) and dosed as described previously, thereby preparing for injection. Once the device has been actuated, the ram may deform a portion of the nozzle assembly (e.g., a portion of the plunger), thereby preventing reuse of the nozzle assembly. The ram may be formed of a hard and/or substantially rigid material, such as steel, and the plunger may be formed of a frangible, soft and/or substantially deformable material, such as a plastic, particularly high impact polystyrene or polycarbonate.

Figures 8-12 illustrate a deformable plunger to prevent reuse of the nozzle assembly. The distal portion 120 of the plunger 116 may include an extension 170 configured to couple the plunger to a drive assembly of a needle-free injection device. To prevent reuse of the nozzle assembly, the extension may be configured to deform upon activation of the device (arming), for example, in response to a force applied along a longitudinal axis of the plunger. In the example shown in fig. 8, ram 50 includes an impact region 60 configured to apply a force to the plunger to deliver an injection and deform a set of extensions radially outward such that the plunger cannot grip the ram. The ram is thus unable to retract the plunger to draw the second dose of injectate into the nozzle assembly.

The extensions may be configured to couple the plunger to various geometries, such as to various shapes of ram impact regions 60. The impact region may include an arcuate portion 62 configured to urge the extension away from the drive member. For example, as shown in fig. 8, the distal portion 122 of the plunger may include an extension configured to grip a spherical impact region of the ram that deforms the extension outward to prevent the extension from further gripping the ram. In the example shown in fig. 9 and 10, the impact region of the ram may include a sharp region, such as a cutting portion 64, configured to deform a set of extensions outwardly upon impact (as shown in fig. 10). Thus, at the start of actuation of the device, the ram deforms a portion of the plunger by circumferential shear. In some configurations of the device, the ram may include a sloped portion 66, such as a wedge-shaped impact region, that pushes a set of extensions apart so that the ram is no longer gripped by the extensions once the device has been activated. The wedge may also be in the form of a separate member that is driven to the trailing end (i.e., distal portion) of the plunger to drive the extensions apart. This member may be retained in the plunger to prevent the extension from being forced back into a position that attempts to bypass the self-disabling mechanism.

As shown in fig. 1 and 8, the needle-free injection device may include a release mechanism 70, such as a ramp, to receive the deformed extension. The ramp may be biased, for example, by a spring 72 to urge the plunger away from the ram and thereby assist in removing the used nozzle assembly. For example, as shown in fig. 12, once the extension 170 is deformed outwardly, the extension rests on the ramp 70. Retraction of the ram will then push the ram out of engagement with the plunger.

While the invention has been shown and described with reference to the foregoing operational principles and preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the invention. The present invention is intended to embrace all such alterations, modifications and variations. The subject matter of the inventions includes all novel and non-obvious combinations and subcombinations of the various elements, features, functions and/or properties disclosed herein. Inventions embodied in various combinations and subcombinations of features, functions, elements, and/or properties may be claimed through presentation of claims in a later application.

Claims (14)

1. A nozzle assembly for a needle-free injection device, comprising:

a nozzle body comprising an injection chamber and one or more outlet orifices; and

a plunger configured to push an injection through the one or more outlet apertures and comprising an extension configured to couple the plunger to a drive assembly of a needle-free injection device, wherein the extension is configured to deform radially outward in response to a force applied along a longitudinal axis of the plunger toward the one or more outlet apertures.

2. A needle-free injection device configured to receive the nozzle assembly of claim 1, comprising a drive assembly having a drive member configured to couple with the plunger and urge the plunger through the injection chamber to expel injectate through the one or more outlet orifices, the drive member comprising an impact region configured to apply a force to the plunger toward the one or more outlet orifices and thereby deform the extension radially outward.

3. The needle-free injection device of claim 2, wherein the impact region comprises an arcuate portion configured to urge the extension away from the transmission member.

4. The needle-free injection device of claim 2, wherein the impact region comprises a cut portion configured to push the extension away from the transmission member.

5. The needle-free injection device of claim 2, wherein the impact region comprises a sloped portion configured to urge the extension away from the transmission member.

6. The needle-free injection device of claim 2, wherein the device comprises a ramp configured to receive the deformed extension and biased to urge the plunger away from the drive member.

7. A nozzle assembly for a needle-free injection device, comprising:

a nozzle body comprising an injection chamber and one or more outlet orifices; and

a plunger configured to move through the injection chamber toward the one or more outlet orifices, the plunger comprising a first portion and a second portion removably joined by a frangible region, the plunger further comprising an extension configured to couple the plunger to a drive assembly of a needle-free injection device, wherein the drive assembly is configured to push the plunger toward the one or more outlet orifices and thereby deform the extension radially outward.

8. The nozzle assembly of claim 7, wherein the first and second portions are configured to break away along the frangible region and at least one of the first and second portions is configured to remain in the injection chamber after an injection is completed.

9. The nozzle assembly of claim 7, wherein the frangible region is configured to be generated in response to a force applied along a longitudinal axis of the plunger.

10. A needle-free injection device configured to receive the nozzle assembly of claim 7, comprising a drive assembly having a drive member configured to couple with the plunger and urge the plunger through the injection chamber toward the one or more outlet orifices to expel injectate through the one or more outlet orifices, the drive member comprising an impact region configured to force the plunger and thereby deform the extension radially outward.

11. The needle-free injection device of claim 10, wherein the impact region comprises an arcuate portion configured to urge the extension away from the transmission member.

12. The needle-free injection device of claim 10, wherein the impact region comprises a cut portion configured to push the extension away from the transmission member.

13. The needle-free injection device of claim 10, wherein the impact region comprises a sloped portion configured to urge the extension away from the transmission member.

14. The needle-free injection device of claim 10, wherein the device comprises a ramp configured to receive the deformed extension and biased to urge the plunger away from the drive member.