Multi-Shot Injection Patch

Abstract

This wearable multi-shot injection patch comprises: a base that has a bottom surface and a top surface and is configured so that the bottom surface is disposed against a patient's skin; a first container that is supported by the base and accommodates a first drug; a second container that is supported by the base and accommodates a second drug; a first pyrotechnic charge disposed between the top surface and the first container inside the base; a second pyrotechnic charge disposed between the top surface and the second container inside the base; and one or more electronic components configured to detonate the first pyrotechnic charge and the second pyrotechnic charge.

Description

[Technical field]

[0001] The present disclosure relates to apparatus and methods for needle-free injection of medications. More particularly, the apparatus and methods relate to wearable devices that provide multiple needle-free injections of medications through a patient's skin. [Background technology]

[0002] Needle-free injection systems are known. The motive forces employed by these systems include pyrotechnics, springs, or electromagnetic actuators, etc. (see, for example, U.S. Patent Publication 1). However, the devices of these systems are of single-shot design and have a significant length, making them unsuitable as wearable devices. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2016-49246 A Summary of the Invention [Problem to be solved by the invention]

[0004] In certain medical applications, it may be advantageous to utilize a needle-free injection device. Certain embodiments of the present invention provide multiple needle-free injection devices mounted on a single wearable patch. For example, a doctor may require a patient to receive an injection of a medication every three hours for three days. Currently, if the patient is unable to inject themselves, or if the type of injection is not suitable for the patient to administer themselves, a medical professional may need to make frequent visits to the patient, or the patient may need to make frequent visits to a health clinic, or may need to be hospitalized while undergoing treatment. An embodiment of the present invention allows the patient to wear the device of the present invention and automatically administer the necessary injections, possibly while performing normal daily activities. [Means for solving the problem]

[0005] In certain embodiments, each injection device is activated by an electrical current that ignites a pyrotechnic charge within the injection device. In certain embodiments, electronics are employed to control the activation or ignition of each injection device. In certain embodiments, the electronics can independently activate or ignite each injection device. In certain embodiments, the patch is compact and thin enough to be worn by the patient so that injections can be administered remotely or in a predetermined time sequence.

[0006] In certain embodiments, the patch is about 5 mm to 10 mm thick. In certain embodiments, the patch is suitable as a wearable device. In certain embodiments, where each injection device has a diameter of about 5 mm to 10 mm, several injection devices can be placed on the same wearable patch.

[0007] In some embodiments, the wearable multi-shot injection patch can include a base having a bottom surface and a top surface. The bottom surface is configured to be placed against the patient's skin. The patch further includes a first receptacle supported by the base and containing a first medicament, and a second receptacle supported by the base and containing a second medicament. A first pyrotechnic charge is disposed within the base between the top surface and the first receptacle. A second pyrotechnic charge is disposed within the base between the top surface and the second receptacle. The one or more electronic components are configured to trigger the first pyrotechnic charge and the second pyrotechnic charge. A first nozzle is supported by the base and is disposed on an opposite side of the first receptacle from the first pyrotechnic charge. A second nozzle is supported by the base and is disposed on an opposite side of the second receptacle from the second pyrotechnic charge.

[0008] In some embodiments, a wearable multi-shot injection patch can include a base having a bottom surface and a top surface. The bottom surface is configured to be placed against the skin of a patient. Two or more containers are supported by the base and contain a solution including one or more medicaments and other ingredients. The two or more containers release the solution simultaneously or sequentially by using a pyrotechnic charge that is ignited by an electrical pulse to cause the solution to penetrate (permeate) the skin of the patient.

[0009] In some embodiments, a wearable injection patch can include a base having a bottom surface and a top surface. The bottom surface is configured to be placed against a patient's skin. The reservoir is formed by an outer wall and contains a medicament. The outer wall is supported by the base. A pyrotechnic charge is disposed within the base between the reservoir and the outer wall.

[0010] In some embodiments, a method for manufacturing a wearable multi-shot injection patch can include providing a first subassembly having a bottom surface and a top surface and including a plurality of containers disposed between the bottom surface and the top surface. The bottom surface is configured to be placed against a patient's skin. Each container in the plurality of containers contains a medicament. The method continues by providing a second subassembly including a plurality of chambers. Each chamber in the plurality of chambers contains a pyrotechnic charge. The method continues by joining the second subassembly to the top surface of the first subassembly such that the plurality of chambers are disposed on opposite sides of the plurality of containers from the bottom surface.

[0011] In some embodiments, a method for injecting a medicament through a patient's skin with a wearable patch having a bottom surface and a top surface can include attaching (adhering) a bottom surface of a wearable patch to the patient's skin, the bottom surface including a plurality of containers and a plurality of chambers aligned with the plurality of containers, the plurality of containers being disposed between the bottom surface and the top surface, each container housing a medicament, and each of the plurality of chambers being disposed between the plurality of containers and the top surface, each chamber having a pyrotechnic charge; and detonating the pyrotechnic charge in at least one of the plurality of chambers and compressing at least one of the plurality of containers to eject the medicament from at least the container through the patient's skin.

[0012] In some embodiments, a wearable multi-shot injection patch can include a base having a bottom surface and a top surface, the bottom surface configured to be placed against a patient's skin, a first container supported by the base and housing a first medicament, a second container supported by the base and housing a second medicament, a first pyrotechnic charge disposed within the base between the top surface and the first container, and a second pyrotechnic charge disposed within the base between the top surface and the second container. Effect of the Invention

[0013] The disclosed technology provides a wearable injection patch for needle-free injection of medication through a patient's skin. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a perspective view of an embodiment of a patch including multiple injection devices distributed throughout the patch, in accordance with a preferred embodiment of the present invention. [Diagram 2] FIG. 2 is a top view of the patch of FIG. 1 showing one or more electronic components for detonating multiple pyrotechnic charges for multiple injection devices. [Diagram 3]FIG. 3 is a perspective exploded view of the patch of FIG. 1, showing two or more containers containing a solution aligned below and above the clamping sheet, a mask layer, and a number of pyrotechnic charges. [Figure 4] FIG. 4 is a cross-sectional view of the patch of FIG. 2 taken along section plane 4-4 of FIG. 2, showing three nozzles of the multiple injection devices covered by removable release liners before the patch is attached to a patient's skin. [Diagram 5] FIG. 5 is a cross-sectional view similar to FIG. 4, except that the release liner has been removed and one of the pyrotechnic charges has been detonated to eject solution from its nozzle and into the patient's skin. [Figure 6] FIG. 6 is a perspective exploded view of a first component assembly of a patch including one or more electronic components, a plurality of pyrotechnic charges, a mask layer, and a sheet. [Figure 7A] Fig. 7A is a cross-sectional view of the first component assembly of Fig. 6 taken along section plane 7A-7A of Fig. 6 and showing a circuit board supporting one of the pyrotechnic charges assembled to the lower surface of the mask layer. The sheet is shown assembled to the upper surface of the mask layer such that one of the diaphragms in the sheet is aligned with one of the chambers in the mask layer. [Figure 7B] FIG. 7B is a cross-sectional view similar to FIG. 7A, except that a circuit board is assembled on the bottom surface of the mask layer and a sheet is assembled on the top surface of the mask layer. [Figure 8] 8 is a perspective exploded view of a second part assembly of the patch including a clamping sheet and two or more reservoirs aligned with recesses in the clamping sheet. A removable release liner is shown positioned above the clamping sheet. [Figure 9A] 9A is a cross-sectional view of the second component assembly of FIG. 8 taken along section plane 9A-9A of FIG. 8, showing one of two or more containers assembled in one of the recesses of the clamping sheet. A removable release liner is shown above the clamping sheet. [Figure 9B]FIG. 9B is a cross-sectional view similar to FIG. 9A, except that a container has been inserted into a recess in the clamping sheet and a release liner has been attached to the clamping sheet. [Figure 10] FIG. 10 shows an alternative embodiment of the container of FIG. 4 having a truncated triangular shape. [Figure 11] FIG. 11 shows an alternative embodiment of the container of FIG. 4 having a truncated pentagonal shape. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. Note that each configuration and their combinations in each embodiment are merely examples, and addition, omission, substitution, and other modifications of the configurations are possible as appropriate within the scope of the present invention. The present disclosure is not limited by the embodiments, but is limited only by the claims.

[0016] 1 is a perspective view of an embodiment of a patch 10 including multiple injection devices 11 (see FIG. 5) distributed throughout the patch 10, in accordance with a preferred embodiment of the present invention. In certain embodiments, the patch 10 comprises a base 12 having a bottom surface 14 and a top surface 16. The bottom surface 14 is configured to be placed against a patient's skin 13, as best seen in FIG. 5.

[0017] In certain embodiments, patch 10 includes two or more reservoirs 18(a)-(i). In certain embodiments, two or more reservoirs 18(a)-(i) are supported by base 12. In certain embodiments, two or more reservoirs 18(a)-(i) contain a drug. In certain embodiments, the drug is a solution 44. In certain embodiments, solution 44 includes one or more drugs and other ingredients. In certain embodiments, the drug or solution 44 in two or more reservoirs 18(a)-(i) are the same. In certain embodiments, the drug or solution 44 in two or more reservoirs 18(a)-(i) are different. In certain embodiments, the drug or solution 44 in two or more reservoirs 18(a)-(i) are different but complementary to one another.

[0018] In certain embodiments, each of the two or more containers 18(a)-(i) comprises a flexible, spherical-shaped container for receiving the solution 44. In certain embodiments, the solution 44 is received by injecting the solution 44 into the two or more containers 18(a)-(i). In certain embodiments, the solution 44 is injected into the two or more containers 18(a)-(i) prior to assembly of the patch 10. In certain embodiments, the solution 44 is injected into the two or more containers 18(a)-(i) during assembly of the patch 10. In certain embodiments, the solution 44 is injected into the two or more containers 18(a)-(i) after assembly of the patch 10.

[0019] In certain embodiments, the patch 10 comprises a plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the plurality of pyrotechnic charges 20(a)-(i) are supported by the base 12. The plurality of pyrotechnic charges 20(a)-(i) may comprise any suitable ignition material. In certain embodiments, each of the plurality of pyrotechnic charges 20(a)-(i) comprises a mixture of zirconium and potassium perchlorate. In certain embodiments, the mixture further comprises a binder. In certain embodiments, the plurality of pyrotechnic charges 20(a)-(i) are deposited as a wet slurry and then dried.

[0020] The multiple pyrotechnic charges 20(a)-(i) are configured to release the solution 44 from the two or more containers 18(a)-(i) in a controlled manner. In certain embodiments, the two or more containers 18(a)-(i) desirably have sufficient flexibility such that the combustion and expansion of the pyrotechnic charge 20 can deform the containers sufficiently to eject the solution 44 or agent through one or more nozzles 26(a)-(i) associated with each of the two or more containers 18(a)-(i). As the solution 44 is ejected, it desirably penetrates the patient's skin 13. In certain embodiments, the multiple pyrotechnic charges 20(a)-(i) cause the solution 44 to be ejected from the multiple (two or more) containers 18(a)-(i) simultaneously. In certain embodiments, the multiple pyrotechnic charges 20(a)-(i) release the solution 44 sequentially (sequentially) from multiple (two or more) containers 18(a)-(i).

[0021] In certain embodiments, the solution 44 released by the multiple pyrotechnic charges 20(a)-(i) penetrates (penetrates) the skin 13 to a desired depth in the skin 13. In certain embodiments, the desired depth is predefined. In certain embodiments, the desired depth is determined based at least in part on the composition of the released agent or solution 44. For example, the desired depth can be set to a different depth for each injection device 11 on the same patch 10.

[0022] In certain embodiments, the patch 10 includes one or more electronic components 22 for initiating (igniting) the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 are supported by the base 12.

[0023] In certain embodiments, the one or more electronic components 22 are configured to generate an electrical current to detonate the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 are configured to selectively detonate the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 are configured to independently detonate each of the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 are configured to simultaneously detonate two or more of the plurality of pyrotechnic charges 20(a)-(i).

[0024] In certain embodiments, one or more of the electronic components 22 are configured to be remotely controlled. In certain embodiments, one or more of the electronic components 22 are configured to be controlled in a predetermined time sequence.

[0025] In certain embodiments, the one or more electronic components 22 comprise a controller. In certain embodiments, the controller is a microcontroller. In certain embodiments, the controller is programmable. In certain embodiments, the one or more electronic components 22 are programmed with the number of injections required, the injection interval, and the appropriate reservoirs 18(a)-(i) that house the desired medication or solution 44. In certain embodiments, once the patch 10 is applied to the patient's skin 13, the patch 10 automatically administers the medication without intervention from a medical professional.

[0026] In certain embodiments, the controller is configured to store instructions for detonating at least one of the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the instructions specify a detonation interval for the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 include a timer. In such embodiments, the controller may be configured to detonate at least one of the plurality of pyrotechnic charges 20(a)-(i) based at least in part on the timer.

[0027] In certain embodiments, the one or more electronic components 22 include a receiver configured to receive a wireless signal. In such embodiments, the one or more electronic components 22 may be configured to detonate at least one of the plurality of pyrotechnic charges 20(a)-(i) based at least in part on the wireless signal. In certain embodiments, the receiver is configured to receive a wireless signal from a patient. In certain embodiments, the receiver is configured to receive a wireless signal from a medical professional.

[0028] In certain embodiments, the patch 10 includes a user interface configured for a patient to activate one or more electronic components 22 to detonate at least one of the plurality of pyrotechnic charges 20(a)-(i).

[0029] In certain embodiments, the patch 10 includes an energy source for the one or more electronic components 22. In certain embodiments, the energy source is supported by the base 12. In certain embodiments, the energy source may be a battery 24. In certain embodiments, the battery 24 powers the one or more electronic components 22 to fire a selected injection device 11. In certain embodiments, the one or more electronic components 22 deliver a first electrical pulse to a selected one or more of the plurality of pyrotechnic charges 20(a)-(i) during a first time frame and then deliver a second electrical pulse to another selected one or more of the plurality of pyrotechnic charges 20(a)-(i) during a second time frame.

[0030] FIG. 2 is a plan view of the patch 10 of FIG. 1, showing one or more electronic components 22 for detonating multiple pyrotechnic charges 20(a)-(i) for multiple injection devices 11.

[0031] In the illustrated embodiment, the patch 10 includes nine injection devices 11 arranged in a grid pattern. Of course, the disclosure is not so limited. The patch 10 can include as few as two injection devices 11. In other embodiments, the patch 10 includes more than nine injection devices 11.

[0032] In the illustrated embodiment, two or more containers 18(a)-(i) have the same size. Of course, the disclosure is not so limited. In certain embodiments, at least one container 18(a)-(i) has a different size than another container 18(a)-(i). In certain embodiments, size is a measure of the outer diameter of a container 18(a)-(i). In certain embodiments, size is a measure of the inner diameter of a container 18(a)-(i). In certain embodiments, size is a measure of the volume of a container 18(a)-(i).

[0033] In certain embodiments, the volumes of the containers 18(a)-(i) are selected based at least in part on the agent or solution 44 contained within the containers 18(a)-(i). For example, a first agent may be more effective than a second agent and therefore require a larger dose. To accommodate changes in dose size, a single patch 10 may include containers 18(a)-(i) having different volumes. In certain embodiments where a patch 10 includes similarly sized containers 18(a)-(i) and a change in dose size is required, one or more electronic components 22 may detonate two or more of the multiple pyrotechnic charges 20(a)-(i) to increase the size of the dose.

[0034] The injection devices 11 can be arranged in a symmetrical or asymmetrical pattern across the base 12 of the patch 10. For example, in certain embodiments, the injection devices 11 are arranged in a square pattern, a circular pattern, or any other spatial arrangement across the base 12 of the patch 10.

[0035] In certain embodiments, a cluster of injection devices 11 are disposed across the base 12 of the patch 10. In certain embodiments, the injection devices 11 in a single cluster are grouped in a linear fashion. In other embodiments, the injection devices 11 in a single cluster are grouped closely together in a single location on the patch 10 (e.g., a circle).

[0036] In the illustrated embodiment, one or more electronic components 22, including a battery 24, are disposed on the periphery of the patch 10. In other embodiments, the one or more electronic components 22 are embedded in the base 12 between the injection devices 11. In other embodiments, the one or more electronic components 22 are disposed on the top surface 16 of the patch 10. In other embodiments, the one or more electronic components 22 are disposed on a side of the base 12.

[0037] 2, each of the two or more containers 18(a)-(i) includes one of the nozzles 26(a)-(i). In certain embodiments, the nozzles 26(a)-(i) are supported by the base 12. In certain embodiments, the nozzles 26(a)-(i) are positioned on an opposite side of the two or more containers 18(a)-(i) from the plurality of pyrotechnic charges 20(a)-(i). In the illustrated embodiment, the nozzles 26(a)-(i) are arranged in a grid pattern across the patch 10.

[0038] As shown in FIG. 2, each nozzle 26(a)-(i) is aligned with one of the containers 18(a)-(i). In certain embodiments, each nozzle 26(a)-(i) is in fluid communication with one of two or more containers 18(a)-(i). In certain embodiments, two or more nozzles 26(a)-(i) are in fluid communication with one of two or more containers 18(a)-(i). In certain other embodiments, each nozzle 26(a)-(i) is in fluid communication with two or more containers 18(a)-(i). For example, the pyrotechnic charge 20 for the first injection device 11 ejects a medicament or solution 44 from one of the containers 18 through the nozzle 26(a), and then the second injection device 11 ejects a medicament or solution 44 from another one of the containers 18 through the nozzle 26(a). Also, for example, the pyrotechnic charge 20 for a first injection device 11 may eject a medicament or solution 44 from one of the containers 18 through nozzle 26(a) while at the same time a second, possibly adjacent, injection device 11 ejects a medicament or solution 44 from another one of the containers 18 through nozzle 26(a).

[0039] The nozzles 26(a)-(i) can extend at least partially beyond the downstream ends of the two or more containers 18(a)-(i). The nozzles 26(a)-(i) can be configured to output the agent or solution 44 from the two or more containers 18(a)-(i). In some embodiments, the nozzles 26(a)-(i) can output the agent or solution 44 in a pressurized manner. For example, the nozzles 26(a)-(i) can direct the pressurized agent or solution 44 toward the patient's skin 13.

[0040] In certain embodiments, the size of the nozzles 26(a)-(i) is selected based at least in part on the desired depth to which the agent will penetrate (penetrate) the skin 13. For example, the size of the nozzles 26(a)-(i) may be selected to achieve a desired velocity of the jet of agent or solution 44 exiting the nozzles 26(a)-(i) that achieves the desired depth of penetration through the skin 13. In certain embodiments, the diameter of the nozzles 26(a)-(i) is smaller than the diameter of the two or more containers 18(a)-(i) when at least the plurality of pyrotechnic charges 20(a)-(i) are undetonated.

[0041] In some embodiments, the nozzles 26(a)-(i) can output the agent or solution 44 in a predetermined direction. For example, the nozzles 26(a)-(i) can output the agent or solution 44 along a front-to-back axis (longitudinal axis) of the nozzles 26(a)-(i). In some embodiments, the nozzles 26(a)-(i) can direct the agent or solution 44 to a predetermined location on the patient's skin 13. In some embodiments, two or more of the nozzles 26(a)-(i) are aligned to direct the agent or solution 44 to the same location on the patient's skin 13.

[0042] For example, in certain embodiments, the first nozzle 26 is positioned such that when the one or more electronic components 22 detonate the first pyrotechnic charge 20, at least a portion of the first agent 44 exits the first nozzle 26 and penetrates the patient's skin 13. The second nozzle 26 is positioned such that when the one or more electronic components 22 detonate the second pyrotechnic charge 20, at least a portion of the second agent 44 exits the second nozzle 26 and penetrates the patient's skin 13. In certain embodiments, the first nozzle 26 and the second nozzle 26 are positioned relative to each other such that at least a portion of the first agent 44 penetrates the patient's skin 13 at a location different from the location at which at least a portion of the second agent 44 penetrates the patient's skin 13. In certain other embodiments, the first nozzle 26 and the second nozzle 26 are positioned relative to each other such that at least a portion of the first agent 44 penetrates the patient's skin 13 at the same location as at least a portion of the second agent 44 penetrates the patient's skin 13.

[0043] In certain embodiments, the nozzles 26(a)-(i) are manufactured as integral elements with the two or more containers 18(a)-(i). For example, the nozzles 26(a)-(i) can be formed by an opening through the wall of the two or more containers 18(a)-(i). In alternative embodiments, the nozzles 26(a)-(i) are manufactured as separate elements from the two or more containers 18(a)-(i) and then positioned relative to the two or more containers 18(a)-(i). In certain embodiments, the nozzles 26(a)-(i) are positioned relative to the two or more containers 18(a)-(i) by gluing, ultrasonically welding, or clamping the nozzles 26(a)-(i) to the two or more containers 18(a)-(i). In certain embodiments, the separately manufactured nozzles 26 can be positioned relative to an opening through the wall of the containers 18. In such embodiments, the inner diameter of the nozzle 26 may be smaller than the diameter of the opening in the wall of the container 18 to provide a narrower flow path that accelerates the jet of drug or solution 44 out of the container 18.

[0044] In certain embodiments, nozzles 26(a)-(i) have a constant inner diameter. In certain embodiments, nozzles 26(a)-(i) have an inner diameter that converges in the direction of the flow (flow path). In certain embodiments, nozzles 26(a)-(i) have an inner diameter that diverges in the direction of the flow (flow path). In certain embodiments, nozzles 26(a)-(i) have an inner diameter that converges and then diverges in the direction of the flow.

[0045] In certain embodiments, nozzles 26(a)-(i) may have one or more vanes formed within the internal flow path. In certain embodiments, one or more vanes are sized and shaped to straighten solution 44 passing through nozzle 26. The vanes may reduce turbulence within solution 44 as it is expelled from nozzle 26. In certain embodiments, nozzle 26 is formed as a screen. In certain embodiments, the screen has a plurality of pores. In certain embodiments, the pores are micropores.

[0046] In the illustrated embodiment, two or more containers 18(a)-(i) each include a single nozzle 26. Of course, the disclosure is not so limited. In certain embodiments, a single container 18 may include multiple nozzles 26. In embodiments in which a container 18 is associated with multiple nozzles 26, each nozzle 26 may have the same or a different size as other nozzles 26 associated with the same container 18.

[0047] Figure 3 is a perspective exploded view of the patch 10 of Figure 1 showing two or more containers 18(a)-(i) prior to insertion into the clamping sheet 50. Figure 3 further illustrates the layered arrangement of the clamping sheet 50, sheet 40, and mask layer 36 over the multiple pyrotechnic charges 20(a)-(i). Also shown is the manner in which a removable release liner 48 is disposed over the patch 10.

[0048] In certain embodiments, the patch 10 comprises a printed circuit board (PCB) or circuit board 28 that supports the multiple pyrotechnic charges 20(a)-(i). In certain embodiments, the circuit board 28 is flexible to allow the bottom surface 14 of the base 12 to conform to the surface of the patient's limb or torso. In certain embodiments, the circuit board 28 need not be flexible. For example, for application to a patient area with less curvature, the circuit board 28 only needs to be curved or flexible enough to contact the skin 13. For example, a smaller patch 10 may be less flexible or curved since it will have a similarly smaller contact surface on the skin 13. In certain embodiments, the circuit board 28 further supports one or more electronic components 22.

[0049] In certain embodiments, the circuit board 28 includes at least one trace 32(a)-(i) extending between the one or more electronic components 22 and each of the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the at least one trace 32(a)-(i) is configured to enable the one or more electronic components 22 to individually detonate each of the plurality of pyrotechnic charges 20(a)-(i). In certain embodiments, the one or more electronic components 22 and the plurality of pyrotechnic charges 20(a)-(i) are arranged such that the one or more electronic components 22 are directly electrically connected to the plurality of pyrotechnic charges 20(a)-(i) without the use of the at least one trace 32(a)-(i).

[0050] In certain embodiments using at least one wire 32(a)-(i), the at least one wire 32(a)-(i) may follow any path between the one or more electronic components 22 and the plurality of pyrotechnic charges 20(a)-(i) on the circuit board 28. For example, in the illustrated embodiment, a portion 30 of the at least one wire 32(a)-(i) extends laterally from the one or more electronic components 22 before each wire 32 individually turns to extend generally longitudinally towards its respective pyrotechnic charge 20.

[0051] Each trace 32 (i.e., trace 32(a)) may comprise two separate wires for completing at least a portion of an electrical circuit with one or more electronic components 22. In certain embodiments, each pyrotechnic charge 20 is associated with two wires in each trace 32. The two traces 32 or wires form part of an electrical circuit between one or more electronic components 22 and each of the multiple pyrotechnic charges 20.

[0052] In certain embodiments, the patch 10 includes a clamping sheet 50. In certain embodiments, the clamping sheet 50 supports two or more containers 18(a)-(i). For example, in certain embodiments, the two or more containers 18(a)-(i) are inserted into respective recesses 56(a)-(i) in the clamping sheet 50. In certain embodiments, each recess 56(a)-(i) is formed as a flow stagnation portion in the clamping sheet 50. In certain embodiments, each flow stagnation portion is sized and shaped to generally conform to an outer surface of the two or more containers 18(a)-(i).

[0053] In certain embodiments, the top openings (closest to the seat 40) in the recesses 56(a)-(i) are sized to facilitate insertion of two or more containers 18(a)-(i) into the recesses 56(a)-(i) of the clamping seat 50 during assembly. In certain embodiments, the openings (at the top of the recesses 56) have a diameter equal to or greater than the maximum diameter of the two or more containers 18(a)-(i). In certain other embodiments, the openings (at the top of the recesses 56) have a diameter slightly smaller than the maximum diameter of the two or more containers 18(a)-(i) but still allow for insertion of two or more containers 18(a)-(i) into the recesses 56(a)-(i) of the clamping seat 50 during assembly.

[0054] In certain embodiments, the bottom surface (closest to the release liner 48) of each recess 56(a)-(i) includes an opening through the clamping sheet 50. In certain embodiments, the openings (at the bottom surface of the recesses 56) are sized smaller than the diameters of the two or more containers 18(a)-(i). In this manner, the two or more containers 18(a)-(i) are inhibited from passing through the openings (at the bottom surface) of the clamping sheet 50 as the multiple pyrotechnic charges 20(a)-(i) deform the two or more containers 18(a)-(i) to eject solution 44.

[0055] In certain embodiments, the patch 10 comprises a sheet 40. In certain embodiments, the sheet 40 comprises a polymeric material. In certain other embodiments, the sheet 40 comprises a non-polymeric material. In certain embodiments, the sheet 40 is disposed on an opposite side of the two or more containers 18(a)-(i) from the clamping sheet 50. In certain embodiments, the sheet 40 is joined to the clamping sheet 50 by, for example, ultrasonic welding, gluing, clipping, and clamping. When assembled, the sheet 40 provides a barrier between the plurality of pyrotechnic charges 20(a)-(i) and the two or more containers 18(a)-(i).

[0056] In certain embodiments, the sheet 40 includes one or more diaphragms 42(a)-(i). In the illustrated embodiment, each diaphragm 42(a)-(i) is associated with one of the two or more containers 18(a)-(i). In certain embodiments, each diaphragm 42(a)-(i) is associated with two or more of the two or more containers 18(a)-(i). In certain embodiments, the sheet 40 includes a single diaphragm 42 and a perimeter portion surrounding the single diaphragm 42.

[0057] In certain embodiments, the diaphragms 42(a)-(i) are flexible. In certain embodiments, the diaphragms 42(a)-(i) are more flexible than the rest of the sheet 40 (other than the diaphragm 42). In certain embodiments, the diaphragms 42(a)-(i) are as flexible as the rest of the sheet 40. The flexibility of the diaphragms 42(a)-(i) may enable the diaphragms 42 to protrude into the recesses 56(a)-(i) of the clamping sheet 50 in response to a pressure spike generated by the multiple pyrotechnic charges 20(a)-(i) and compress the two or more containers 18(a)-(i).

[0058] In certain embodiments, the sheet 40 is generally flat and has a constant thickness throughout the sheet 40. In certain embodiments, the sheet 40 is generally flat except in the areas of the diaphragms 42(a)-(i). In certain embodiments, the thickness of the sheet 40 in the areas of the diaphragms 42(a)-(i) is less than the thickness of the remainder of the sheet 40. In certain embodiments, the areas of the diaphragms 42(a)-(i) have a dome shape. In certain embodiments, the areas of the diaphragms 42(a)-(i) have a shape that generally matches the shape of the portions of the two or more containers 18(a)-(i) adjacent the diaphragms 42 when assembled.

[0059] In certain embodiments, the patch 10 includes a mask layer 36. In certain embodiments, the mask layer 36 forms a spacer between the circuit board 28 and the two or more containers 18(a)-(i). In certain embodiments, the mask layer 36 forms a barrier between adjacent pyrotechnic charges 20(a)-(i). In certain embodiments, the barrier inhibits one injection device 11 from sympathetically activating another injection device 11.

[0060] In certain embodiments, the mask layer 36 comprises one or more chambers 38. In certain embodiments, each chamber 38 has a cylindrical shape. In certain other embodiments, each chamber 38 has a square shape or any other shape. In certain embodiments, each of the one or more chambers 38 is associated with one injection device 11. In the illustrated embodiment, each of the one or more chambers 38(a)-(i) is associated with one of the plurality of pyrotechnic charges 20(a)-(i).

[0061] In the illustrated embodiment, each of the one or more chambers 38(a)-(i) has an open top and an open bottom. In certain embodiments, one or both of the top and bottom of each of the one or more chambers 38(a)-(i) are closed. In the illustrated embodiment, the one or more chambers 38(a)-(i) extend in a direction away from the circuit board 28. In other embodiments, the mask layer 36 is flipped upside down relative to the embodiment shown in FIG. 3, and in such embodiments, the one or more chambers 38(a)-(i) extend in a direction toward the circuit board 28.

[0062] In certain embodiments, the mask layer 36 is bonded or otherwise attached to the circuit board 28 via ultrasonic welding, adhesive, clipping, clamping, or other attachment means. In some embodiments, the mask layer 36 is compressed between the sheet 40 and the circuit board 28. In certain embodiments, the mask layer 36 is bonded or otherwise attached to the sheet 40 by ultrasonic welding, adhesive, clipping, clamping, or other attachment means. In certain embodiments, the mask layer 36 comprises a polymeric material. Of course, the disclosure is not so limited and the mask layer 36 can be made from a non-polymeric material.

[0063] 4 is a cross-sectional view of the patch 10 taken along section plane 4-4 in FIG. 2 and shows the nozzles 26(d), 26(e), 26(f) covered by a removable release liner 48 before the patch 10 is attached to the patient's skin 13. In certain embodiments, a seal 46 is disposed within the nozzles 26(a)-(i). The seal 46 inhibits leakage of the solution 44 from the two or more containers 18(a)-(i) when the injection device 11 is not actuated. Once the injection device 11 is actuated, pressure within the two or more containers 18(a)-(i) caused by compression of the containers 18 breaks the seal 46, allowing the solution 44 to pass and exit the nozzle 26.

[0064] In certain embodiments, the patch 10 comprises a plurality of resistive wires 34(a)-(i). FIG. 4 shows resistive wires 34(d), 34(e), 34(f). In certain embodiments, the resistive wires 34(a)-(i) are in contact with a plurality of pyrotechnic charges 20(a)-(i). In the illustrated embodiment, the resistive wire 34(d) is in contact with the pyrotechnic charge 20(d). In the illustrated embodiment, the resistive wire 34(e) is in contact with the pyrotechnic charge 20(e). In the illustrated embodiment, the resistive wire 34(f) is in contact with the pyrotechnic charge 20(f).

[0065] In certain embodiments, the resistive wires 34(a)-(i) are further in electrical contact with at least one of the wirings 32 (see FIG. 3). In the illustrated embodiment, the resistive wire 34(d) is in contact with the wiring 32(d). In the illustrated embodiment, the resistive wire 34(e) is in contact with the wiring 32(e). In the illustrated embodiment, the resistive wire 34(f) is in contact with the wiring 32(f). As described above, each wiring 32 (i.e., the wiring 32(e)) can comprise two separate wires for completing at least a portion of an electrical circuit with one or more electronic components 22. For example, one or more electronic components 22 can be electrically connected to one end of each of the two wires of the wiring 32(d). Each end of the resistive wire 34(d) can then be electrically connected to one of the other ends of each of the two wires of the wiring 32(d) completing the electrical circuit.

[0066] In a particular embodiment, resistive wire 34 has a diameter of 20 microns. In some embodiments, resistive wire 34 has a length of 0.5 mm. In some embodiments, resistive wire 34 has a resistance of 1 ohm. Of course, the disclosure is not so limited. Resistive wires 34(a)-(i) can have any length, diameter, and / or resistance value.

[0067] FIG. 5 is a cross-sectional view similar to FIG. 4, except that the release liner 48 has been removed and one of the pyrotechnic charges 20(e) has been detonated to eject (discharge) the solution 44 from its nozzle 26(e) and into the patient's skin 13. In FIG. 5, pressure from the burning pyrotechnic charge 20(e) moves or pushes a portion of the container 18(e) further into the recesses 56(a)-(i) of the clamping seat 50, increasing the pressure within the container 18(e). In this manner, the pyrotechnic charge 20(e) provides pressure to force a jet of solution 44 through the nozzle 26(e) and into or through the skin 13. The burning pyrotechnic charge 20(e) itself does not pass through the nozzle 26(e) and does not enter or penetrate the skin 13.

[0068] In certain embodiments, the burned pyrotechnic charge 20(e) is contained within the patch 10. In certain other embodiments, the burned pyrotechnic charge 20(e) is allowed to escape through the nozzle 26(e), but at a velocity sufficiently attenuated so as not to enter the skin 13.

[0069] In certain embodiments, when the solution 44 is ejected from the container 18(e), the sheet 40 and / or the wall of the container 18(e) do not rupture, maintaining a barrier between the burned pyrotechnic charge 20(e) and the patient's skin 13. In certain embodiments, when the solution 44 is ejected from the container 18(e), both the sheet 40 and the wall of the container 18(e) rupture, but the size and shape of the rupture, for example, sufficiently attenuates the rate at which the burned pyrotechnic charge 20(e) escapes so that the burned pyrotechnic charge does not enter the skin 13. In such embodiments, the source of force that propels the solution 44 into the skin 13 is still the driving force (momentum) of the solution 44 itself, and not accidental contact between the skin 13 and any post-burn pyrotechnic charge 20(e) that may have escaped from the patch 10.

[0070] In certain embodiments, the height of the chambers 38(a)-(i) is selected to provide sufficient space between the plurality of pyrotechnic charges 20(a)-(i) and the sheet 40 to allow pressure from the burning pyrotechnic charges 20(a)-(i) to adequately compress the two or more containers 18(a)-(i) releasing the solution 44 without rupturing the two or more containers 18(a)-(i). In certain embodiments, the height of the chambers 38(a)-(i) is selected to provide sufficient space between the plurality of pyrotechnic charges 20(a)-(i) and the sheet 40 to allow pressure from the burning pyrotechnic charges 20(a)-(i) to adequately compress the two or more containers 18(a)-(i) releasing the solution 44 without rupturing the sheet 40. In certain embodiments, the height of the chamber 38 is selected to provide sufficient space between the plurality of pyrotechnic charges 20(a)-(i) and the sheet 40 to allow the pressure from the burning pyrotechnic charges 20(a)-(i) to adequately compress the two or more containers 18(a)-(i) releasing the solution 44 without causing the sheet 40 and any of the two or more containers 18(a)-(i) to rupture. In certain embodiments, the height of the chamber 38 is selected to provide sufficient space between the plurality of pyrotechnic charges 20(a)-(i) and the sheet 40 to allow the pressure of the burning pyrotechnic charge 20 to adequately compress the two or more containers 18(a)-(i) releasing the solution 44 while attenuating the pressure of the burning pyrotechnic charge 20 that may escape through a rupture of the sheet 40 and the containers 18(a)-(i).

[0071] 6 is an exploded perspective view of a first subassembly of patch 10 including one or more electronic components 22, a plurality of pyrotechnic charges 20(a)-(i), a mask layer 36, and a sheet 40. The mask layer 36 includes a plurality of chambers 38(a)-(i) for the plurality of pyrotechnic charges 20(a)-(i).

[0072] Figure 7A is a cross-sectional view of the first component assembly of Figure 6 taken along section plane 7A-7A of Figure 6 and shows the circuit board 28 supporting the pyrotechnic charge 20(b) assembled to the underside of the mask layer 36. The sheet 40 is shown assembled to the top side of the mask layer 36 such that the diaphragm 42(b) in the sheet 40 is aligned with the chamber 38(b) in the mask layer 36.

[0073] Figure 7B is a cross-sectional view similar to Figure 7A, except that circuit board 28 is assembled to the bottom surface of mask layer 36 and sheet 40 is assembled to the top surface of mask layer 36. In certain embodiments, one or all of the components of the first part assembly are joined to one another by, for example, ultrasonic welding, gluing, clipping, or clamping.

[0074] 8 is a perspective exploded view of a second subassembly of patch 10 including a clamping sheet 50 and two or more receptacles 18(a)-(i). In the embodiment shown, the two or more receptacles 18(a)-(i) are aligned with recesses 56(a)-(i) in clamping sheet 50. A removable release liner 48 is shown disposed above clamping sheet 50.

[0075] In certain embodiments, patch 10 includes an adhesive layer 54. In certain embodiments, adhesive layer 54 is configured to secure patch 10 to a patient's skin 13. In certain embodiments, adhesive layer 54 is configured to allow patch 10 to be secured to a patient's skin 13 for a period of time (continuously).

[0076] In certain embodiments, the release liner 48 includes a tab 52 for facilitating removal of the release liner 48 from the clamp sheet 50. In certain embodiments, the patch 10 includes a strap coupled to the base 12. The strap is configured to be secured around a limb or torso of the patient to maintain contact between the patient's skin 13 and the underside 14.

[0077] Figure 9A is a cross-sectional view of the second component assembly of Figure 8 taken along section plane 9A-9A of Figure 8 and shows container 18(b) installed in one of recesses 56(a)-(i) of clamping sheet 50. Release liner 48 is shown above clamping sheet 50.

[0078] Figure 9B is a cross-sectional view similar to Figure 9A, except that container 18(b) is inserted into recesses 56(a)-(i) of clamping sheet 50 and release liner 48 is attached to clamping sheet 50. In certain embodiments, one or all of the components of the second part assembly are joined to one another by, for example, ultrasonic welding, gluing, clipping, or clamping.

[0079] In certain embodiments, the first component assembly of FIG. 7B and the second component assembly of FIG. 9B are joined together, for example, by ultrasonic welding, gluing, clipping, or clamping, to form the final assembly of patch 10 as illustrated in FIG. 4.

[0080] In certain embodiments, a method for manufacturing a patch 10 begins by providing a first component assembly as shown in FIG. 7B. The first component assembly has a bottom surface, a top surface, and two or more containers 18(a)-(i) disposed between the bottom surface and the top surface. The bottom surface is configured to be disposed against the skin 13 of a patient. In certain embodiments, each container 18 in the two or more containers 18(a)-(i) contains a solution or agent 44. The method continues with providing a second component assembly as shown in FIG. 9B. The second component assembly has a plurality of chambers 38(a)-(i). In certain embodiments, each chamber 38 in the plurality of chambers 38(a)-(i) contains one of the plurality of pyrotechnic charges 20(a)-(i). The method continues with bonding the second component assembly to the top surface of the first component assembly such that the plurality of chambers 38(a)-(i) are disposed on opposite sides of the two or more containers 18(a)-(i) from the bottom surface. In certain embodiments, the multiple chambers 38(a)-(i) are aligned with two or more containers 18(a)-(i) when at least a second component assembly is joined to the first component assembly. The method continues with the first component assembly and the second component assembly being joined together, for example by ultrasonic welding, gluing, clipping, or clamping, to form a final assembly.

[0081] Figure 10 shows another embodiment of the two or more containers 18(a)-(i) of Figure 4 having a truncated triangular shape. Figure 11 shows another embodiment of the two or more containers 18(a)-(i) of Figure 4 having a truncated pentagonal shape. Of course, the shape of the two or more containers 18(a)-(i) is not limited to the disclosed shapes and can instead have any shape.

[0082] The following additional notes are provided regarding the above embodiment. (Appendix 1) a base having a bottom surface and a top surface, the bottom surface configured to be placed against the patient's skin; a first container supported by the base and containing a first medicament; a second container supported by the base and containing a second medicament; a first pyrotechnic charge disposed within the base between the upper surface and the first container; a second pyrotechnic charge disposed within the base between the upper surface and the second container; one or more electronic components configured to initiate the first and second pyrotechnic charges; A wearable multi-shot injection patch comprising: (Appendix 2) one or more electronic components configured to initiate the first and second pyrotechnic charges; a first nozzle supported by the base and positioned on an opposite side of the first container from the first pyrotechnic charge; a second nozzle supported by the base and positioned on an opposite side of the second container from the second pyrotechnic charge; 2. The wearable multi-shot injection patch of claim 1, further comprising: (Appendix 3) the first nozzle is positioned such that when the one or more electronic components detonate the first pyrotechnic charge, at least a portion of the first agent exits the first nozzle and penetrates the skin of the patient; 3. The wearable multi-shot injection patch of claim 2, wherein the second nozzle is positioned such that when the one or more electronic components detonate the second pyrotechnic charge, at least a portion of the second medicament is ejected from the second nozzle and penetrates the patient's skin. (Appendix 4) 4. The wearable multi-shot injection patch of claim 3, wherein the first nozzle and the second nozzle are positioned relative to each other such that at least a portion of the first medicament penetrates the patient's skin at a location different from a location at which at least a portion of the second medicament penetrates the patient's skin. (Appendix 5) 4. The wearable multi-shot injection patch of claim 3, wherein the first nozzle and the second nozzle are positioned relative to each other such that at least a portion of the first medicament penetrates the patient's skin at the same location as at least a portion of the second medicament penetrates the patient's skin. (Appendix 6) 6. The wearable multi-shot injection patch of any of claims 1 to 5, wherein the base has a circuit board, the bottom surface of the circuit board being flexible so that it can conform to the surface of a patient's limb or torso. (Appendix 7) 7. The wearable multi-shot injection patch of any of claims 1 to 6, wherein the base includes an adhesive layer configured to adhere the wearable multi-shot injection patch to the patient's skin. (Appendix 8) 8. The wearable multi-shot injection patch of any of claims 1 to 7, further comprising a strap connected to the base and securable around the patient's limb or torso to maintain contact between the bottom surface and the patient's skin. (Appendix 9) 9. The wearable multi-shot injection patch of any of claims 1 to 8, wherein the one or more electronic components are configured to generate an electrical current to detonate the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 10) 10. The wearable multi-shot injection patch of any of claims 1 to 9, wherein the one or more electronic components are configured to selectively detonate the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 11) 10. The wearable multi-shot injection patch of any of claims 1 to 9, wherein the one or more electronic components are configured to independently detonate each of the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 12) 10. The wearable multi-shot injection patch of any of claims 1 to 9, wherein the one or more electronic components are configured to simultaneously detonate both the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 13) 13. The wearable multi-shot injection patch of any of claims 1 to 12, wherein the one or more electronic components are configured to be remotely controlled. (Appendix 14) 13. The wearable multi-shot injection patch of any of claims 1 to 12, wherein the one or more electronic components are configured to be controlled in a predetermined time sequence. (Appendix 15) 15. The wearable multi-shot injection patch of any of claims 1 to 14, wherein the one or more electronic components comprise a microcontroller, the microcontroller configured to store instructions for detonating at least one of the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 16) 16. The wearable multi-shot injection patch of claim 15, wherein the instructions specify an interval for detonating the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 17) 17. The wearable multi-shot injection patch of claim 15 or 16, wherein the one or more electronic components comprise a timer, and the microcontroller is configured to detonate at least one of the first pyrotechnic charge and the second pyrotechnic charge based at least in part on the timer. (Appendix 18) 18. The wearable multi-shot injection patch of any of claims 1 to 17, further comprising a battery configured to power the one or more electronic components. (Appendix 19) 19. The wearable multi-shot injection patch of any of claims 1 to 18, wherein the one or more electronic components comprise a receiver configured to receive a wireless signal, and the one or more electronic components are configured to detonate at least one of the first pyrotechnic charge and the second pyrotechnic charge based at least in part on the wireless signal. (Appendix 20) 20. The wearable multi-shot injection patch of claim 19, wherein the receiver is configured to receive the wireless signal from the patient. (Appendix 21) 20. The wearable multi-shot injection patch of claim 19, wherein the receiver is configured to receive the wireless signal from a medical professional. (Appendix 22) 22. The wearable multi-shot injection patch of any of claims 1 to 21, further comprising a user interface configured for the patient to activate the one or more electronic components to detonate the first pyrotechnic charge and / or the second pyrotechnic charge. (Appendix 23) 23. The wearable multi-shot injection patch of any of claims 1 to 22, wherein the base comprises at least one first wiring extending between the one or more electronic components and the first pyrotechnic charge. (Appendix 24) 24. The wearable multi-shot injection patch of any of claims 1 to 23, wherein the base comprises at least one first wiring extending between the one or more electronic components and the second pyrotechnic charge. (Appendix 25) 24. The wearable multi-shot injection patch of claim 23, wherein the base further comprises a resistive wire in contact with the first pyrotechnic charge and electrically connected to the first wiring. (Appendix 26) 25. The wearable multi-shot injection patch of claim 24, wherein the base further comprises a resistive wire in contact with the second pyrotechnic charge and electrically connected to the second wiring. (Appendix 27) 27. The wearable multi-shot injection patch of claim 25 or 26, wherein the resistive wire has a diameter of 20 microns. (Appendix 28) 28. The wearable multi-shot injection patch of any of claims 25 to 27, wherein the resistive wire has a length of 0.5 mm. (Appendix 29) 29. The wearable multi-shot injection patch of any of claims 25 to 28, wherein the resistive wire has a resistance of 1 ohm. (Appendix 30) 30. The wearable multi-shot injection patch of any of claims 1-29, wherein the first pyrotechnic charge and the second pyrotechnic charge comprise at least one of zirconium and potassium perchlorate. (Appendix 31) 31. The wearable multi-shot injection patch of any of claims 1 to 30, wherein the first pyrotechnic charge and the second pyrotechnic charge comprise a dry slurry. (Appendix 32) the base includes a mask layer that defines a first chamber and a second chamber; the first pyrotechnic charge is disposed in the first chamber and the second pyrotechnic charge is disposed in the second chamber; 32. The wearable multi-shot injection patch of any of claims 1-31, wherein at least a portion of the first chamber and at least a portion of the second chamber form a barrier between the first pyrotechnic charge and the second pyrotechnic charge. (Appendix 33) 33. The wearable multi-shot injection patch of claim 32, wherein the mask layer comprises a polymeric material. (Appendix 34) the base further comprises a sheet disposed between the mask layer and both the first container and the second container; 34. The wearable multi-shot injection patch of claim 32 or 33, wherein the sheet has a first diaphragm positioned over the first chamber and a second diaphragm positioned over the second chamber. (Appendix 35) 35. The wearable multi-shot injection patch of claim 34, wherein the sheet and the mask layer are joined together by any of ultrasonic welding, gluing, clipping, and clamping. (Appendix 36) 36. The wearable multi-shot injection patch of claim 34 or 35, wherein each of the first diaphragm and the second diaphragm has a dome shape. (Appendix 37) 37. The wearable multi-shot injection patch of claim 36, wherein each of the first container and the second container has a spherical shape. (Appendix 38) the first diaphragm is flexible such that when the one or more electronic components detonate the first pyrotechnic charge, the first pyrotechnic charge creates a pressure spike causing the first diaphragm to move toward the first container and eject at least a portion of the first agent from the first container; the second diaphragm is flexible such that when the one or more electronic components detonate the second pyrotechnic charge, the second pyrotechnic charge creates a pressure spike causing the second diaphragm to move toward the second container and eject at least a portion of the second agent from the second container. 38. The wearable multi-shot injection patch of any of claims 34 to 37. (Appendix 39) 39. The wearable multi-shot injection patch of any of claims 1 to 38, wherein the first container and the second container are disposed at least partially within the base. (Appendix 40) the first nozzle is disposed in the first opening; and and an outer wall defining the second container and having a second opening, the second nozzle being disposed in the second opening. A wearable multi-shot injection patch as described in appended claim 2. (Appendix 41) a first nozzle is sized and shaped such that at least a portion of the first agent ejected from the first nozzle forms a jet of liquid having a velocity sufficient to penetrate the patient's skin to a desired depth at a first location; the second nozzle is sized and shaped such that at least a portion of the second agent ejected from the second nozzle forms a jet of liquid at the second location having a velocity sufficient to penetrate the patient's skin to a desired depth; A wearable multi-shot injection patch as described in appended claims 2 or 40. (Appendix 42) 42. The wearable multi-shot injection patch of any one of claims 1 to 41, wherein the base further comprises a clamping sheet, and the first container and the second container are disposed within the clamping sheet. (Appendix 43) 43. The wearable multi-shot injection patch of any one of claims 1 to 42, wherein the first medicament is the same as the second medicament. (Appendix 44) 44. The wearable multi-shot injection patch of any of claims 1-43, wherein the first medicament is different from the second medicament. (Appendix 45) 45. The wearable multi-shot injection patch of claim 44, wherein the first medicament is complementary to the second medicament. (Appendix 46) 46. ​​The wearable multi-shot injection patch of claim 1-45, wherein the one or more electronic components detonate the first pyrotechnic charge and the second pyrotechnic charge simultaneously or sequentially. (Appendix 47) 1. A method for making a wearable multi-shot injection patch, comprising: providing a first component assembly having a bottom surface and a top surface, the first component assembly including a plurality of containers disposed between the bottom surface and the top surface, the bottom surface being configured to be placed against a patient's skin, each of the plurality of containers containing a medicament; providing a second subassembly having a plurality of chambers, each of the plurality of chambers having a pyrotechnic charge; bonding the second subassembly to the top surface of the first subassembly such that the chambers are disposed on an opposite side of the containers from the bottom surface; A method for producing a multi-shot injection patch comprising: (Appendix 48) 48. The method of claim 47, wherein the plurality of chambers are aligned with the plurality of reservoirs when at least the second component assembly is joined to the first component assembly. (Appendix 49) 49. The method for manufacturing a multi-shot injection patch according to claim 47 or 48, wherein the second component assembly is joined to the first component assembly by any of ultrasonic welding, gluing, clipping, and clamping. (Appendix 50) 1. A method of injecting a medication through a patient's skin using a wearable patch having a bottom surface and a top surface, comprising: attaching the bottom surface of the wearable patch to the patient's skin, the patch including a plurality of containers and a plurality of chambers aligned with the plurality of containers, the plurality of containers being disposed between the bottom surface and the top surface, each container housing a medicament, and each of the plurality of chambers being disposed between the plurality of containers and the top surface, each chamber having a pyrotechnic charge; detonating the pyrotechnic charge in at least one of the plurality of chambers and compressing at least one of the plurality of containers to eject the agent from at least the container through the patient's skin; An injection method comprising:

[0083] <Terminology> Although specific embodiments and examples are disclosed herein, the subject matter of the present invention extends beyond the examples in the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the specific embodiments described above. For example, in any method or process disclosed herein, the acts or steps (operations) of the method or process may be performed in any suitable order and are not necessarily limited to the specific disclosed order. Although various steps (operations) may be described in sequence as multiple separate steps (operations) in a manner that may be helpful in understanding a particular embodiment, the order of description should not be construed to imply that these steps (operations) are order dependent. Furthermore, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages in these embodiments are described. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one aspect, advantage, or group of advantages as taught herein, without necessarily achieving other aspects or advantages as may be taught or suggested herein.

[0084] It should be understood that features, materials, properties, or combinations thereof described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere herein to the extent compatible therewith. All features disclosed herein (including the accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except where at least some of such features and / or steps are mutually exclusive. Not necessarily all such aspects or advantages are achieved by any particular embodiment. For example, the one or more features include: 1) a container for the medicament, 2) a nozzle in the container, 3) an outer wall forming the container, 4) an opening in the container, 5) an outlet smaller than the container for accelerating the medicament, 6) a structure for compressing the container to eject the medicament, 7) a diaphragm sheet, 8) a structure for pushing the diaphragm sheet to eject the medicament, 9) a particular chamber shape, 10) a structure for inhibiting the pyrotechnic charge (explosive powder) from contacting the skin, and / or 11) a structure for inhibiting the pyrotechnic charge from mixing with the medicament. Thus, protection is not limited to the details of the foregoing embodiments. Protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including the claims, abstract, and drawings), or to any novel one, or any novel combination, of steps in the methods or processes so disclosed.

[0085] Moreover, certain features that are described in the disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in a particular combination, one or more features from a claimed combination can, in some cases, be carved out of the combination and the combination claimed as a subcombination or a variation of the subcombination.

[0086] Furthermore, although steps may be shown in the figures or described herein in a particular order, such steps need not all be performed in the particular order or sequential order shown to achieve the desired results. Other steps not shown or described may be incorporated into the exemplary methods and processes. For example, one or more additional steps may be performed before, after, simultaneously with, or between the steps described. Furthermore, steps may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from those shown. Depending on the embodiment, some of the above steps may be omitted and other steps may be added. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. Also, the separation of various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the components and systems described may generally be integrated into a single product or packaged into multiple products.

[0087] For the purpose of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages can be achieved according to a particular embodiment. Thus, for example, a person skilled in the art will recognize that the present disclosure can be embodied or carried out in a manner that achieves one advantage or a group of advantages taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0088] For purposes of explanation, the term "horizontal" as used herein is defined as a plane parallel to the plane or surface of the floor or ground of the area in which the described apparatus is used or the described method is performed, regardless of its orientation. The term "floor" may be substituted for the term "ground". The term "vertical", as defined, refers to a direction perpendicular to the horizontal. Terms such as "above", "below", "bottom", "top", "side", "higher", "lower", "upper", "over" and "under" are defined relative to the horizontal plane.

[0089] In particular, conditional terms used herein, such as "can," "could," "might, may," "eg," and the like, are generally intended to convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not, unless otherwise specified or understood in the context in which they are used. Thus, such conditional terms do not generally imply that features, elements, and / or steps are somehow required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included in or should be performed in any particular embodiment, with or without other input or instructions. Terms such as "comprises," "includes," "having," and the like, are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (and not exclusive), e.g., when used to connect a list of elements, the term "or" may mean one, some, or all of the elements in the list.

[0090] Conjunctions such as "at least one of X, Y, and Z," unless otherwise noted, are understood apart from the context in which they are commonly used to convey that an article, term, etc. can be either X, Y, or Z. Thus, such conjunctions do not generally imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0091] As used herein, "degree of language," such as the terms "approximately," "about," "generally," and "substantially," refer to a value, amount, or characteristic that is close to the stated value, amount, or characteristic and still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from strictly parallel by no more than 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other.

[0092] Although the multi-shot patch has been disclosed in the context of specific embodiments and examples, it will be understood by those skilled in the art that the multi-shot patch and subassembly extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the embodiments, as well as modifications and equivalents thereof. Accordingly, the scope of the multi-shot patch disclosed herein should not be limited by the specific disclosed embodiments described above, but should be determined only by a fair reading of the following claims.

[0093] Each feature disclosed herein may be combined with any other feature disclosed herein. [Explanation of symbols]

[0094] 10... Patch 11...Injection device 12...Base 18...container 20. Pyrotechnic Charge 22 Electronic Components 26 Nozzle 28 Circuit board 32 Wiring 36 Mask layer 38. Chamber 40...sheets 42 Diaphragm 50···Clamp seat

Claims

1. a base having a bottom surface and a top surface, the bottom surface configured to be placed against the patient's skin; a first container supported by the base and containing a first medicament; a second container supported by the base and containing a second medicament; a first pyrotechnic charge disposed within the base between the upper surface and the first container; a second pyrotechnic charge disposed within the base between the upper surface and the second container; one or more electronic components configured to initiate the first and second pyrotechnic charges; Equipped with the base has a circuit board, the first pyrotechnic charge and the second pyrotechnic charge are supported on the circuit board, and a spacer is formed between the first container and the second container and the circuit board; A wearable multi-shot injection patch.

2. a first nozzle supported by the base and positioned on an opposite side of the first container from the first pyrotechnic charge; a second nozzle supported by the base and positioned on an opposite side of the second container from the second pyrotechnic charge; 10. The wearable multi-shot injection patch of claim 1, further comprising:

3. A wearable multi-shot injection patch as described in claim 1 or 2, wherein the bottom surface of the circuit board is flexible so that it can conform to the surface of a patient's limb or torso.

4. 4. The wearable multi-shot injection patch of claim 1, wherein the base includes an adhesive layer configured to adhere the wearable multi-shot injection patch to the patient's skin.

5. 5. Any of claims 1 to 4, further comprising a strap connected to the base and securable around a limb or torso of the patient to maintain contact between the bottom surface and the patient's skin.

10. A wearable multi-shot injection patch according to any one of claims 1 to 9.

6. 6. The wearable multi-shot injection patch of claim 1, wherein the one or more electronic components are configured to selectively detonate the first pyrotechnic charge and the second pyrotechnic charge or to detonate both simultaneously.

7. 7. The wearable multi-shot injection patch of claim 1, wherein the one or more electronic components are configured to be remotely controlled or controlled in a predetermined time sequence.

8. 8. The wearable multi-shot injection patch of claim 1, wherein the one or more electronic components comprise a microcontroller, the microcontroller configured to store instructions for detonating the first pyrotechnic charge and / or the second pyrotechnic charge.

9. 9. The wearable multi-shot injection patch of claim 1, wherein the one or more electronic components comprise a receiver configured to receive a wireless signal, and the one or more electronic components are configured to detonate at least one of the first pyrotechnic charge and the second pyrotechnic charge based at least in part on the wireless signal.

10. A method of treating a patient comprising: providing a device for treating a patient comprising: providing a device for treating a patient having a patient body; and a first container supported by the base and containing a first medicament; a second container supported by the base and containing a second medicament; a first pyrotechnic charge disposed within the base between the upper surface and the first container; a second pyrotechnic charge disposed within the base between the upper surface and the second container; one or more electronic components configured to initiate the first and second pyrotechnic charges; Equipped with the base includes a mask layer that defines a first chamber and a second chamber; the first pyrotechnic charge is disposed in the first chamber and the second pyrotechnic charge is disposed in the second chamber; at least a portion of the first chamber and at least a portion of the second chamber form a barrier between the first pyrotechnic charge and the second pyrotechnic charge; the base further comprises a sheet disposed between the mask layer and both the first container and the second container; The sheet has a first diaphragm disposed to cover the first chamber and a second diaphragm disposed to cover the second chamber. A wearable multi-shot injection patch.

11. 11. The wearable multi-shot injection patch of claim 10, wherein the first diaphragm and the second diaphragm each have a dome shape.

12. 12. The wearable, multi-shot injection patch of claim 11, wherein the first reservoir and the second reservoir each have a spherical shape.

13. When the one or more electronic components detonate the first pyrotechnic charge, the first pyrotechnic charge creates a pressure spike that moves the first diaphragm toward the first container and ejects at least a portion of the first agent from the first container. The diaphragm of one is flexible, the second diaphragm is flexible such that when the one or more electronic components detonate the second pyrotechnic charge, the second pyrotechnic charge creates a pressure spike causing the second diaphragm to move toward the second container and eject at least a portion of the second agent from the second container.

13. A wearable multi-shot injection patch according to any one of claims 10 to 12.

14. 14. The wearable multi-shot injection patch of claim 1, wherein the base further comprises a clamping sheet, the first container and the second container being disposed within the clamping sheet.

15. 1. A method for making a wearable multi-shot injection patch, comprising: providing a first subassembly having a bottom surface and a top surface, the first subassembly including a plurality of containers disposed between the bottom surface and the top surface, the bottom surface being configured to be placed against a patient's skin, each of the plurality of containers containing a medicament; providing a second subassembly comprising a plurality of chambers, each of said plurality of chambers having a pyrotechnic charge; bonding the second subassembly to the top surface of the first subassembly such that the chambers are disposed on an opposite side of the containers from the bottom surface; Including, the second subassembly includes a circuit board; the plurality of chambers are aligned with the plurality of containers at least when the second subassembly is joined to the first subassembly, thereby forming spacers between the plurality of containers and the circuit board. A method for manufacturing a multi-shot injection patch.

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