CN212662367U

CN212662367U - Wearable non-liquid medicine injection device

Info

Publication number: CN212662367U
Application number: CN201890000573.6U
Authority: CN
Inventors: Z.刘; T.怀特赫斯特; M.陈; C.吕
Original assignee: Verily Life Sciences LLC
Current assignee: Verily Life Sciences LLC
Priority date: 2017-01-09
Filing date: 2018-01-09
Publication date: 2021-03-09
Anticipated expiration: 2028-01-09
Also published as: EP3565618A1; WO2018129519A1

Abstract

The utility model relates to a device for inciting somebody to action injectable substance injects in user, a serial communication port, include: a housing defining a chamber having a first end and a second end; a piston disposed toward a first end of the chamber and translatable within the chamber; a hollow needle disposed within the chamber and extending from a front face of the piston toward the second end of the chamber; an energetic material disposed within the first end of the chamber and behind the piston to force the piston and the hollow needle toward the second end of the chamber in response to activation of the energetic material; and a drug strip disposed within the hollow needle and comprising an injectable substance.

Description

Wearable non-liquid medicine injection device

Cross Reference to Related Applications

The present application claims priority from U.S. provisional application No. 62/505457 entitled "System and method for Wearable Emergency Drug Injection Devices" (Systems and Methods for Wearable Emergency Drug Injection Devices) filed on 12.5.2017 and U.S. provisional application No. 62/444237 entitled "Electronically Actuated Drug Delivery System" (filed on 9.1.2017), the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to a wearable non-liquid drug injection device, in particular to a system and method for on-demand delivery of non-liquid drugs from a wearable drug injection device.

Background

A person with certain medical conditions may require drugs that respond to certain physiological conditions. Medical needles are widely used in patient care and treatment procedures, particularly in the delivery of drugs to patients. In one common form, a hollow hypodermic needle is used to deliver a selected drug transdermally from a syringe or the like. In another common form, an insertion needle is used to percutaneously place a soft and relatively flexible tubular cannula, and then the needle is inserted to remove and then infuse medical fluids or drugs through the cannula into the patient. For example, some diabetics may monitor their blood glucose to bring the blood glucose level as close to normal as possible without causing hypoglycemia. The drugs for treating diabetes are achieved by lowering blood glucose levels. In response to hyperglycemia, a person or healthcare provider may inject insulin, such as with a hypodermic needle or insertion needle for a tubular cannula, to help lower blood glucose levels.

Some people are unwilling or hesitant to pierce their own skin with medical needles and therefore encounter difficulty in proper needle placement for proper drug administration. This difficulty may be due to insufficient manual dexterity or skill to achieve proper needle placement, or alternatively anxiety associated with anticipated discomfort due to needle penetration through the skin. This problem can be overcome using an automatic drug delivery device. In another common form, medical needles are provided in automatic injectors for quickly and easily placing the insertion needle through the skin of a patient at the correct insertion angle and with an insertion speed and force that minimizes patient discomfort. For example, some people are severely allergic to allergens such as peanut or insect bites and allergic reactions may occur as a result of exposure to allergens. Epinephrine (adrenal hormone) is the primary treatment for anaphylaxis and has no absolute contraindications for its use. In response to an allergic reaction, the person or healthcare provider may inject epinephrine, such as with an off-the-shelf auto-injector, e.g., EpiPon^TMTo stop the allergic reaction.

Although such as EpiPon^TMThe automatic injector of (1) is capable of automatically placing an insertion needle through the skin of a patient at the correct insertion angle to deliver a drug, but still requires manual intervention by the patient or healthcare provider (e.g., someone still has to position the injector on the skinAnd activating the trigger for injection). However, during an emergency situation, the user may not have the ability to seek assistance or self-administer a medication. Thus, having a wearable drug injection device that is capable of delivering a drug on demand when the device receives a signal that a user requires a drug may likewise be life saving.

A major challenge in delivering medication on demand from a medication injection device is the need to wear the device and should be able to maintain a discreet footprint on the patient, i.e., a small overall size and low profile, to maintain customer satisfaction. However, many drugs such as glucagon are typically stored as 1mL solutions (liquid solutions or dry liquid mixture solutions) in one or more chambers of a drug injection device, which occupy a significant portion of the overall size of the drug injection device. Therefore, the ability to minimize the space occupied by drug storage is important to the success of wearable drug injection devices. Furthermore, optimizing the automatic on-demand delivery of drugs is important for the overall treatment of medical conditions and the adoption of such delivery devices. Accordingly, there is a need for systems and methods having the ability to automatically deliver medication on demand from a wearable medication injection device.

SUMMERY OF THE UTILITY MODEL

One general aspect includes a device for injecting an injectable substance into a user includes a housing defining a chamber having a first end and a second end. The device also includes a piston disposed toward the first end of the chamber and translatable within the chamber. The device also includes a hollow needle disposed within the chamber and extending from a front face of the piston toward the second end of the chamber. The device also includes an energetic material disposed within the first end of the chamber and behind the piston to force the piston and the hollow needle toward the second end of the chamber in response to activation of the energetic material. The device further comprises a drug strip disposed within the hollow needle and comprising an injectable substance.

Implementations may include one or more of the following features. The drug strip includes one or more polymers and the injectable substance is in a non-liquid form that is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed within the one or more polymers. The device also includes a spring disposed within the chamber and extending from a front face of the piston toward the second end of the chamber. The device also includes a rear hub attached to the end of the drug strip and disposed within the chamber and in front of the piston. The device further includes a snap feature disposed at the second end of the chamber, wherein the snap feature includes a mating structure that engages and locks the rear hub in position at the second end of the chamber once the piston is forced toward the second end of the chamber in response to activation of the energetic material. The device also includes an opening in the housing to the external environment. The device further includes a needle guide defining a curved path that forces the hollow needle to bend toward the opening. The device also includes a reusable portion comprising: a starting circuit and a receiver, wherein the starting circuit is connectable to the energetic material and configured to activate the energetic material upon receiving an activation command from the receiver. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium.

Another general aspect includes a device for injecting an injectable substance into a user, comprising: a first portion including a start circuit; and a second portion connected to the first portion. The second portion includes a chamber. The second portion further includes a piston disposed within the chamber. The second portion further includes a needle disposed within the chamber on the first side of the piston. The second portion further includes an energetic material disposed within the chamber on the second side of the piston and connected to the firing circuit. The second portion further includes a drug strip disposed within the needle, wherein the drug strip includes an injectable substance in a non-liquid form.

Implementations may include one or more of the following features. The first portion further includes a battery and one or more capacitors, the battery is configured to store charge in the one or more capacitors, and the starting circuit is configured to: (i) activating the energetic material by coupling one or more capacitors to an activator in contact with the energetic material, and (ii) releasing the stored charge and initiating an exothermic reaction of the energetic material. The drug strip includes one or more polymers and the injectable substance is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed within the one or more polymers. The injectable substance comprises epinephrine or glucagon. The device also includes a spring disposed within the chamber on the first side of the piston. The device also includes a rear hub attached to an end of the drug strip and disposed within the chamber on the first side of the piston. The device further includes a snap feature disposed within the chamber on the first side of the piston, wherein the snap feature includes a mating structure that engages and locks the rear hub in place once the piston is forced through the chamber in response to activation of the energetic material. The device also includes an opening into a second portion of the external environment. The device may further include a needle guide defining a curved path that forces the needle to bend toward the opening, wherein the needle comprises a hollow tube having one tip with an opening. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium.

A system of one or more computers may be configured to perform particular operations or actions by installing software, firmware, hardware, or a combination thereof on the system that in operation causes or causes the system to perform the actions. The one or more computer programs may be configured to perform particular operations or actions by including instructions that, when executed by a data processing apparatus, cause the apparatus to perform the actions. One general aspect includes a method for delivering an injectable substance to a user, including receiving a command to deliver the injectable substance at a first circuit. The method further includes activating an energetic material disposed within a chamber of the injection device to initiate an exothermic reaction that forces a piston through the chamber and drives a needle external to the injection device into a user, wherein a drug strip is disposed within the needle and includes an injectable substance in a non-liquid form. The method further comprises retracting the needle from outside the injection device into the chamber, wherein the drug strip remains in the user upon retraction of the needle. The method further includes delivering the injectable substance to a user. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

Implementations may include one or more of the following features. In the method: the drug strip includes one or more polymers and the injectable substance is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed within the one or more polymers. The method may further comprise delivering the injectable substance to the user by passive diffusion of the injectable substance from the drug strip into the user. In this method, initiating an exothermic reaction causes an increase in pressure behind the piston, which eventually exceeds the force of the spring in the chamber, causing the spring to compress and the piston to pass through the chamber. In this method, retracting the needle includes releasing pressure behind the piston such that when the force of the spring eventually exceeds the pressure, the piston passes through the chamber, retracting the needle into the chamber. In this method, when the piston passes through the chamber and drives the needle outside the injection device, the piston transports a rear hub attached to the end of the drug strip through the chamber and into contact with a snap feature engaging the rear hub, and engagement of the snap feature with the rear hub allows the drug strip to remain in the user while retracting the needle. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium.

Drawings

The invention will be better understood in view of the following non-limiting drawings, in which:

fig. 1 shows a block diagram of a medical injection device according to various embodiments;

fig. 2 shows a block diagram of an exemplary system for controlling a medical injection device, in accordance with various embodiments;

fig. 3-13 illustrate different views and stages of an exemplary wearable medical injection device according to various embodiments; and

fig. 14 illustrates an exemplary flow chart for delivering an injectable substance to a user with a wearable medical injection device, in accordance with various embodiments.

Detailed Description

I. Brief introduction to the drawings

As discussed herein, a problem associated with conventional drug injection devices is that they typically require some form of manual control (e.g., holding the device during injection), and the injected drug is typically stored as a bulk liquid solution. These limitations are detrimental to fully autonomous drug injection devices that may be worn by a user. To address these issues, various embodiments of the systems and/or methods described herein relate to connected wearable drug injection devices that can inject a substance or drug on demand in a non-liquid form such that no liquid solution is required and the overall size and profile of the drug injection device can be reduced. As used herein, "injectable substance" or "drug" includes any desired agent or mixture of agents, and the like, for administration of one or more active agents to an area of a patient. For example, suitable injectable substances or drugs may include epinephrine, glucagon, or a glucagon activating solution, or other drugs or chemicals. As used herein, "non-liquid" refers to a substance that is not a liquid. For example, the non-liquid form may be a solid form of a substance, such as a dry powder medicament. A drug injection device is a device or system having electronic circuit components and/or software configured to deliver a non-liquid substance through an injection needle to a specific site (e.g., subcutaneously or subcutaneously) of a patient.

One or more parts of the drug injection device may be worn on the body of the patient. For example, a user with a medical condition (e.g., diabetes or severe allergy to a substance) may use a wearable drug injection device according to the present disclosure. In this example, a user (also referred to as a "wearer") obtains a device that is about 20mm wide, about 25mm long, and about 1cm high. The example device has two halves that are joined together to form the complete device. The first half may be disposable and have means to store and deliver a dose of injectable substance (e.g. 1mg drug powder). Specifically, the front half includes a piston, a spring, an energetic material, and a hollow needle. Within the needle is a small detachable strip that is about 100um wide, about 50um thick, about 5mm long and contains an injectable substance, such as a drug in dry form (as used herein, "drug strip" when combined). The medicament strip is held at the rear end by a hub. As used herein, the terms "substantially," "about," and "approximately" are defined as largely but not necessarily completely specified (and including completely specified), as understood by one of ordinary skill in the art. In any disclosed embodiment, the terms "substantially", "about" or "approximately" may be substituted with "within" the specified "[ percentage ], where the percentage includes 0.1%, 1%, 5%, and 10%.

The back half of the device (in this example the reusable half) comprises circuitry for receiving a command to inject the injectable substance and activating the energetic material in response to the command. For example, the wearer may press a button on the reusable half to trigger a circuit to activate the charge. Alternatively, the circuitry may receive commands wirelessly from another device, such as a wearer's smartphone, continuous glucose monitor, biosensor, insulin pump, or the like. In this example, the circuit is configured to activate the energetic material on demand, e.g., in response to a signal received from a continuous glucose monitor. The energetic material may be activated by heating the energetic material, which causes a highly exothermic reaction, thereby releasing gas and heat rapidly. The pressure spike from the exothermic reaction forces the piston towards the end of the device and drives the hollow needle and drug strip into the wearer. When the needle and drug strip meet the end of travel, the needle is retracted by the spring and the hub of the drug strip engages a feature at the end of the device, forcing the drug strip to remain in place within the wearer. When the drug band is within the wearer, the drug will passively elute into the wearer. After completion, the wearer can pull the device down and the drug strip will naturally pull out with the device.

Advantageously, these methods provide a drug injection device with small overall size and low profile, which is possible because the conventional liquid holding chamber is removed from the device and replaced with a drug strip stored in a hollow needle. Furthermore, these methods allow on-demand drug delivery without user interaction (full automation). Also advantageously, the drug may be multiplexed on a drug strip to deliver a "mixture of active agents". For example, a portion of the strip may include glucagon, while a second portion of the strip may include an activator for glucagon, which may be simultaneously delivered to the area of interest to enable the glucagon to be metabolized by the wearer. Furthermore, the drug strips described herein may personalize the drug injection device for each individual patient.

Medicament injection device or system

Fig. 1 illustrates a block diagram of a medical injection device 100 in accordance with various aspects. In various embodiments, the device 100 includes two

portions

105 and 110 that are connected but separable from each other. First portion 105 includes an electronic component 115 that can be separated from second portion 110 to allow for reuse of electronic component 115. The second part 110 comprises a chamber 120 for accommodating a syringe comprising a needle 125, such as a hollow needle. In some embodiments, the needle 125 comprises a hollow tube having a pointed tip with a small opening (e.g., fully open, slotted, or partially open) at one end and a blunt tip that is open or closed at the other end. The syringe may be used to drive the needle 125, optionally through the needle cap 130, and into the skin of the user. Within the needle 125 is a detachable drug strip 135 having a width of about 15 to 150 μm, for example a width of 100 μm, a thickness of about 25 to 75 μm, for example a thickness of about 50 μm, and a length of about 2.0 to 7.5mm, for example a length of 5mm, and containing an injectable substance, such as a drug in dry form.

In some embodiments, the tape 135 is constructed of one or more polymers such as silicone, Polytetrafluoroethylene (PTFE), Polyetheretherketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), Polycaprolactone (PCL), polyethylene and Cyclic Olefin Copolymers (COCs), Perfluoroether (PFA), Fluorinated Ethylene Propylene (FEP), polyimide, and polyester. As discussed herein, an injectable substance includes any desired agent or mixture of agents, etc., for administering one or more active agents to an area of a user. For example, suitable injectable substances or drugs may include epinephrine, glucagon, or a glucagon activating solution, or other drugs or chemicals. The injectable substance of strip 135 is in a non-liquid form, which is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed in the one or more polymers. For example, during manufacture of the strip 135, the drug may be immobilized onto the polymeric strip by depositing the injectable substance in liquid form onto the surface of the polymer and/or absorbing the injectable substance into the polymer to create an intermediate assembly (polymeric strip and injectable substance in liquid form), and then freeze-drying the intermediate assembly using standard lyophilization methods to create the final assembly or drug strip (strip 135).

In some embodiments, the injectable substance may include multiple drugs that are multiplexed on a drug strip to deliver an "active agent mixture. For example, a portion of the strip may include glucagon, while a second portion of the strip may include an activator for glucagon, which may be simultaneously delivered to the area of interest to enable the glucagon to be metabolized by the wearer. Further, the strip 135 may have various doses and/or types of medications that are personalized for the user of the device 100, thus personalizing the device 100 to the user. In certain embodiments, because the needle 125 is hollow, the strip 135 may be stored in the needle 125 within the chamber 120. Upon actuation of the injection mechanism, the tape 135 is forced into the user through the needle 125. When the band 135 is within the wearer, the injectable substance may be passively eluted into the wearer. After delivery of the injectable substance into the wearer, the second portion 110 may be discarded.

In some embodiments, the device 100 is designed to be worn flush with the wearer's body, such as on the upper arm or torso. With respect to the description of length, width, and height, the height of the device 100 refers to how far the device 100 extends over the wearer's skin when worn. Conversely, length and width refer to the dimensions of the circumference of the device 100. In certain embodiments, the device 100 is about 15mm to 30mm wide, such as 20mm wide, about 15mm to 35mm long, such as 25mm long, and about 0.5cm to 3cm thick, such as 1cm thick. The needles 125 may be oriented to extend parallel to the wearer's skin; however, the needle guide 140 defines a curved path that forces the needle 125 to curve toward the wearer's skin at an angle of about 30, 35, 40, or 45 degrees from its original orientation. In some embodiments, the needle 125 is formed from a flexible material, such as a nickel titanium alloy (e.g., nitinol), to allow the needle 125 to bend at an angle of up to 45 degrees (or more) without disrupting or impeding the travel path of the strap 135 through the interior of the needle 125. In certain embodiments, the needle 125 is a 22 gauge (gauge) needle, a 23 gauge needle, or a 25 gauge needle. Such device dimensions and needle dimensions provide a mechanism suitable for injecting the tape 135 into a wearer, while providing a device 100 that maintains a small size with a low profile and causes a tolerable amount of discomfort; however, other suitable device sizes and needle sizes and diameters may be employed.

In various embodiments, the housing 142 of the second portion 110 defines a chamber 120 that houses a syringe. The syringe may also include a piston 145, the piston 145 being initially positioned at a first end of the chamber 120 opposite the opening 150 of the housing 142 to the external environment. In some embodiments, chamber 120 is in fluid communication with opening 150. In other embodiments, the chamber 120 is closed from the opening 150 by the needle cap 130. The piston 145 may translate within the chamber 120 (e.g., may move from a first end of the chamber toward a second end). The needle 125 extends from the front of the plunger 145 toward the second end of the chamber (the end near the opening 150). In some embodiments, the needle 125 is attached to a front surface of the plunger 145. Thus, when the plunger is activated and moved toward the opening 150, the needle 125 and the strap 135 located in front of the plunger 145 are forced optionally through the needle cap 130 and the opening 150. Piston 145 may be sized to have approximately the same cross-sectional area as chamber 120 to prevent the contents of chamber 120 from sliding around piston 145, or as described herein, to prevent gas pressure generated behind piston 145 from dissipating by escaping around piston 145. Further, in some embodiments, the piston 145 has one or more seals attached around the perimeter of the piston 145 to prevent such leakage of material or gas through the piston 145.

The syringe may also include an energetic material 155 (e.g., a propellant) disposed behind the piston 145 and connected to one or more electronic components 115 in the first portion 105. When energetic material 155 is activated by one or more electronic components 115, energetic material 155 may undergo an exothermic reaction and create a pressure within a portion of chamber 120 behind piston 145, thereby forcing piston 145 toward a second end of chamber 120 having opening 150. In some embodiments, energetic material 155 comprises a nitrocellulose material. In certain embodiments, energetic material 155 may be modified to produce a faster burning or slower burning material based on the design of apparatus 100. For example, the energetic material 155 may be a nitrocellulose material in a cotton-based format for faster burn, or a paper-based format for a slower burn format. Suitable energetic materials may be selected based on the size and composition of the chamber 120, needle 125, strip 135, piston 145, and/or spring 160.

The syringe may further include a spring 160 disposed within the chamber 120 and extending from the front of the piston 145 toward the second end of the chamber (the end proximate the opening 150). In some embodiments, the spring 160 abuts the front surface of the piston 145. A spring 160 (optionally coupled to the needle cap 130) may be provided to hold the piston 145 in place within the chamber 120 (e.g., abutting the energetic material 155) and enable retraction of the needle 125 once the energetic material 155 pushes the piston 145 toward the second end of the chamber 120. For example, the pressure generated by the energetic material 155 may initially overcome the force of the spring 160, but as the gas from the exothermic reaction dissipates, e.g., through the vent 167, the pressure within the chamber 120 drops and the spring 160 may eventually overcome the pressure and retract the needle 125. In some embodiments, the needle 125 is retracted by the spring 160 when the needle 125 and the strap 135 meet at the end of their travel into the wearer. In additional or alternative embodiments, other needle retraction mechanisms may be employed, such as another propellant charge located beneath the needle cap 130.

In some embodiments, a rear hub 165 is attached to one end of the band 135 and is initially disposed within the chamber 120 and in front of the piston 145. Additionally, a snap feature 170 is provided at a second end of the chamber 120. The snap feature 170 includes a mating structure, such as a clip, to engage the rear hub 165 and lock the rear hub in position at the second end of the chamber 120 once the piston 145 is forced toward the second end of the chamber 120 in response to activation of the energetic material 155. The attachment of the rear hub 165 with the end of the strap 135 and the snap feature 170 allows the strap 135 to remain in place within the wearer during and after retraction of the needle 125.

While the second portion 110 includes a mechanism for storing and injecting the strips 135, the first portion 110 includes a means for receiving a command (or commands) to initiate an exothermic reaction of the energetic material 155 and ultimately drive the strips 135 into the wearer. In various embodiments, the first portion 110 includes a starter circuit 175, a battery 180 or other power source or connection, a wireless receiver 185, and an antenna 190. To initiate the exothermic reaction of energetic material 155, a command may be received from a remote device, such as a wearer's smartphone or biosensor (e.g., a continuous glucose monitor), through antenna 190 and receiver 185, and may be relayed to activation circuit 175. In response to receiving the command, start circuit 175 may apply a signal, voltage, or current to energetic material 155 using power provided by battery 180. In some embodiments, energetic material 155 is activated by an electrical discharge. For example, to provide for discharge, the starter circuit 175 charges one or more capacitors using the battery 180 prior to receiving a command. Upon receiving a command from receiver 185, start circuit 175 couples the capacitor, optionally in turn to an activator (e.g., an electrical lead or conductive contact) in contact with energetic material 155, allowing the capacitor to discharge and initiate an exothermic reaction of energetic material 155.

In addition to the starter circuit 175, battery 180 and receiver 185, other electronic components may also be provided within the first portion 110, such as a battery charging circuit 192, a power supply and filtering circuit 195 and a microcontroller 197, for example an ASIC defined on a field programmable gate array ("FPGA"). Still further electronic components may be included within the first portion 110 to implement various features in accordance with the present disclosure. Although the embodiments discussed herein employ wireless commands to activate the activation circuit 175, it is to be understood that it is contemplated that the device 100 may alternatively have a wired connection to another device, such as a biosensor, or may have a button or other wearer manipulable device ("operator") to activate the activation circuit 175. Further, although the embodiment shown in fig. 1 has two

portions

105, 110 that may be separated from each other, in some examples, the apparatus 100 may be formed from a single portion that includes the components described above or other components in accordance with the present disclosure. Thus, rather than providing a disposable second portion 110 and a reusable first portion 105, the entire device can be reused or discarded.

Fig. 2 shows a block diagram of an example system 200 for controlling a medical injection device 205 (e.g., the medical injection device 100 as discussed with respect to fig. 1). In various embodiments, the apparatus 205 communicates with the remote device 210 via a communication link 215 such that at least the remote device 210 can transmit signals and the apparatus 205 can receive signals (in other embodiments, both the apparatus 205 and the remote device 210 can transmit and receive signals). Remote device 210 may be any suitable apparatus having a wireless transmitter, such as a smartphone, a smart watch, a blood pressure sensor, a continuous glucose monitor, or the like. Such remote devices may be handheld or wearable devices or larger devices, such as one or more sensing systems found in a hospital or other medical office. The communication link 215 may be any suitable wireless or wired communication means between two devices, such as bluetooth, bluetooth low energy ("BLE"), wireless network technology (e.g., Wi-Fi), near field communication ("NFC"), etc. While the apparatus 205, the remote device 210, and the communication link 215 are described herein as a wearable system with respect to several described embodiments, it should be understood that various systems and arrangements including the apparatus 205, the remote device 210, and the communication link 215 are contemplated without departing from the spirit and scope of the present disclosure. For example, the system 200 may include the apparatus 205 and the remote device 210 within a distributed environment, such as a cloud computing environment, and the apparatus 205 and the remote device 210 may communicate via one or more communication networks. Examples of communication networks include, but are not limited to, the internet, a Wide Area Network (WAN), a Local Area Network (LAN), an ethernet, a public or private network, a wired network, a wireless network, and the like, as well as combinations thereof.

In some embodiments, remote device 210 is a continuous glucose monitor that senses and stores the glucose level of the wearer over time. Glucose levels may be accessed wirelessly by various devices, such as a wearer's smartphone, insulin pump, or an exemplary wearable drug injection device according to the present disclosure. The apparatus 210 may be configured with one or more glucose level thresholds below which the wearer is experiencing a hypoglycemic event, and above which the wearer is experiencing a hyperglycemic event. The device 210 may periodically measure the glucose level of the wearer and compare them to one or more glucose level thresholds. If the measured glucose level (or several consecutive measured glucose levels) exceeds one or more glucose level thresholds, the apparatus 210 may determine a hyperglycemic or hypoglycemic event. The device 210 may alert the wearer, such as by sending a signal to the wearer's insulin pump to trigger an audible alarm, and to trigger insulin delivery in the event of a hyperglycemic event. In the event of a hypoglycemic event, the device 210 may also send a signal (e.g., a command signal) to the device 205 to cause the injection mechanism to deliver a dose of glucagon to the wearer. For example, the device 210 may first send a signal to the wearer's insulin pump (if the wearer has one) and continue to monitor the wearer's glucose level to detect whether the wearer's glucose level continues to exceed one or more glucose level thresholds. If the glucose level does not continue to exceed one or more glucose level thresholds, the device 210 may determine that appropriate action has been taken to mitigate the hypoglycemic event (e.g., the wearer has eaten). However, if after a predetermined period of time (e.g., 5 minutes) the hypoglycemic event continues or worsens, the device 210 may determine that intervention is required and send a signal to the device 205 to cause a dose of glucagon to be injected into the wearer. Such an example may be desirable because it may allow the wearer to increase their glucose level even if they do not respond, for example, due to sleep or unconsciousness. While this embodiment relates to hypoglycemic events and continuous glucose monitors, other biosensors may be employed or in lieu of other pathologies and treatments. For example, in some examples a biosensor such as blood pressure, electrocardiogram, blood oxygen, etc. may be employed to detect a medical event such as an allergic reaction, etc., and then the biosensor or other device such as a smartphone may be triggered to send a signal to the device 205 to cause an injectable substance, such as epinephrine, etc., to be injected into the wearer. Thus, different medical events may be automatically addressed or mitigated by the combination of the remote device 210 and the wearable drug injection apparatus 205, which may address emergency situations or may allow for a full medical response to occur in time if desired.

Reference is now made to fig. 3-13, which illustrate different views and stages of an exemplary wearable medical injection device 300. In particular, fig. 3 shows a disposable portion 305 (e.g., the second portion 110 discussed with respect to fig. 1) of a wearable medical injection device 300 that may be connected to a reusable portion (e.g., the first portion 105 discussed with respect to fig. 1). As shown, the reusable portion may be releasably coupled to the disposable portion 305 by a connector 310. The connector 310 may include a plug and/or clip that engages the reusable portion to releasably secure the disposable portion 305 and the reusable portion together. In various embodiments, the housing 315 of the disposable portion 305 defines a chamber 320, the chamber 320 including a piston 325 with one or more sealing rings 330, an energetic material 335, a spring 340, a needle 345, a drug strip 350, a rear hub 355, a needle guide 360, and a snap feature 365. The chamber may have an opening 370 to allow the needle 345 and strip 350 to exit the device 300 through the needle guide 360 and an exhaust port 375 to allow gases generated by the energetic material 335 to escape from the chamber 320. Although fig. 3 shows the vent port 375 releasing gas directly into the environment of the wearer, in some examples, the vent port 375 may vent the gas into the needle retraction mechanism.

As shown in fig. 3, 5, 8 and 11, during the storage phase of the injectable substance, an energetic material 335 (e.g., a propellant) may be disposed behind the piston 325 and connected to one or more electronic components in the first portion by at least a portion of the connector 310 (e.g., the conductive material of the connector). The spring 340 has a sufficient amount of force such that it can hold the piston 325 near the energetic material 335 at the first end 380 of the chamber 320 during the storage phase. The spring 340 may be constructed of one or more materials such as iron, carbon, silicon, manganese, and chromium. The exact composition of the spring 340 depends on the desired characteristics of the device 300, which may include the load that the spring 340 will need to withstand, how many stress and strain cycles the spring 340 will be subjected to, the temperature at which the spring 340 must operate, whether the spring 340 needs to withstand heat or corrosion, how "plastic" (easy to form) the spring 340 needs to be during its initial manufacture and forming, and the like.

As further shown in fig. 3, 5, 8 and 11, during the storage stage of the injectable substance, a needle 345, a strip 350 and a rear hub 355 may be disposed within the chamber 320. Rear hub 355 is attached to the end of strip 350 and may be positioned adjacent to piston 325 toward first end 380 of chamber 320. In this position, the rear hub 355 does not engage the snap feature 365. The needle 345 may be attached to the piston 325 through an opening in the rear hub 355. The needle 345 may be oriented in the chamber 320 to extend parallel to the wearer's skin; however, the needle guide 360 defines a curved path that forces at least a portion of the needle 345 to curve toward the wearer's skin (e.g., a C-shaped curve) at an angle that deviates from its initial orientation by about 25 degrees, 30 degrees, 35 degrees, 40 degrees, or 45 degrees during the storage phase. As shown in fig. 4, the needle 345 may be hollow to allow the strip 350 to be stored within the needle 345 and delivered into the wearer through the needle 345. In some embodiments, the needle 345 comprises a hollow tube having a sharpened tip with an opening (e.g., fully open, slotted, or partially open) at one end and an open or closed blunt tip at the other end. The opening in the needle 345 allows the strip 350 to be loaded into the needle 345 (for storage) and allows the strip 350 to be delivered to a user (from within the needle 345 and into the user). Additionally, the needle 345 may be constructed of a flexible material, such as a suitable plastic or metal material (e.g., nitinol). In this example, the needle 345 is sufficiently flexible that it can be bent at an angle between 25 and 45 degrees without permanent deformation while maintaining an unobstructed path through the needle 345. As shown in fig. 5-10, the needle guide 360 forms or is coupled to an opening 370 to provide a path through which the needle 345 is forced to bend at an angle toward the wearer's skin. Thus, when the needle 345 is driven by the piston 325, the needle 345 moves and passes through a path formed in the needle guide 360 and bends toward the wearer's skin.

Upon receiving a command signal from the receiver, the activation circuit activates the exothermic reaction of the energetic material 335 and the piston 325 is driven from the first end 380 to the second end 385 of the chamber 320 such that the needle 345 and strip 350 are driven from the opening 370 into the wearer's skin. As shown in fig. 6, 9 and 12, during the injection phase of the injectable substance, the needle 345 and the strip 350 are driven from the opening 370 into the skin of the wearer via the needle guide 360, and the rear hub 355 remains attached to one end of the strip 350 but is disposed at the second end 385 of the chamber 320. In this position, the rear hub 355 engages the snap feature 365. In some embodiments, the snap feature 365 is a clip with two hooks for engaging a lip of the rear hub 355 and thereby retaining the rear hub 355 at the second end 385 of the chamber 320. The spring 340 is compressed at the second end 385 of the chamber 320 by the pressure generated by the exothermic reaction of the energetic material 335.

Once the strip 350 has exited the device 300 via the needle 345 and entered the wearer, the device 300 may retract the needle 345 via the spring 340. For example, the pressure generated by the energetic material 335 may initially overcome the force of the spring 340, but when the pressure dissipates, e.g., through the exhaust port 375, the spring 340 may eventually overcome the pressure and retract the needle 345. In additional or alternative embodiments, other needle retraction mechanisms may be employed, such as another propellant charge located below the needle cap. As shown in fig. 7, 10 and 13, during the delivery phase of the injectable substance, the needle 345 is retracted into the chamber 320 and the piston 325 can be positioned again at the first end 380 of the chamber 320. For example, the spring 340 has a sufficient amount of force such that it can hold the piston 325 near the energetic material 335 at the first end 380 of the chamber 320 during the delivery phase. In addition, the first portion 390 of the strap 350 remains outside of the device and inside of the wearer. Second portion 395 of strip 350 remains attached to rear hub 355, and rear hub 355 remains engaged with catch feature 365 so that strip 350 does not retract with needle 345. When the first portion 390 of the strip 350 is inside the wearer, the injectable substance can be passively eluted into the wearer. Once the injectable substance has been delivered, the wearer can pull down on device 300 and, due to the attachment of strip 350 to rear hub 355 and the attachment of rear hub 355 to housing 315 via snap features 365, strip 350 will naturally pull out of the wearer.

Method for delivering a drug

Fig. 4 shows a simplified flow diagram depicting a process performed for delivering an injectable substance to a user, in accordance with various embodiments. As noted herein, the flowchart of fig. 4 illustrates the architecture, functionality, and operations of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

Fig. 4 depicts a simplified flow diagram 400 showing a process for delivering an injectable substance to a user wearing an injection device. This process will be described with respect to the apparatus 100 shown in fig. 1 and the system shown in fig. 2; however, any suitable device or system according to the present disclosure may be employed, such as the exemplary devices shown in fig. 3-13. In step 405, the device 100 receives a command (or commands) to deliver an injectable substance. In this example, device 100 receives a command from remote device 210 via a BLE wireless activation signal. To send the command, the remote device 210 may first establish a communication connection with the apparatus 100, such as by pairing with the apparatus using the BLE protocol, and then authenticate itself to the apparatus 100, for example, by providing encrypted communications that include a digital signature or certificate. After establishing communication and authenticating itself to the apparatus 100, the remote device 210 sends an activation signal that may include a command. And in this example the remote device 210 does not need such a feature while authenticating itself to the apparatus 100. Instead, remote device 210 may simply transmit an activation signal, such as by broadcasting the activation signal, which may include a command.

In response to receiving the command (or commands) to deliver the injectable substance, device 100 activates energetic material 155 to generate pressure and force piston 145 toward the opposite end of the chamber, step 410. In this example, the starter circuit 175 closes a switch to discharge a capacitor onto an energizer that is in contact with the energetic material 155. The discharge from the capacitor ignites the energetic material 155 and initiates an exothermic reaction. The exothermic reaction produces a gas that fills chamber 120 and increases the pressure in chamber 120 behind piston 145. The pressure eventually exceeds the force of the spring 160 and the piston 145 passes through a portion of the chamber 120, forcing the needle 125 and the detachable drug strip 135 through the needle guide 140, optionally through the needle cap 130 and the opening 150 of the device 100. If the device 100 is worn by a patient, the needle 125 and the detachable drug strip 135 are injected into the wearer.

In step 415, the device 100 retracts the needle 125. If the device 100 is worn by a patient, a portion of the drug strip 135 remains in the wearer during retraction of the needle 125. In this example, the spring 160 is compressed by the movement of the piston 145 and the pressure generated by the exothermic reaction. After a sufficient amount of gas dissipates, for example, through the exhaust port 167, the spring 160 can eventually overcome the pressure and retract the needle 125. In additional or alternative embodiments, other needle retraction mechanisms may be employed, such as another propellant charge located below the needle cap 130. At step 420, the portion of the band 135 left within the wearer delivers the injectable substance to the wearer. For example, the injectable substance may be passively eluted from the strip 135 into the wearer. Once the injectable substance has been delivered, the wearer can pull down the device 100 and the strap 135 will naturally pull out of the wearer due to the attachment of the strap 135 to the rear hub 165 and the attachment of the rear hub 165 to the housing 142 via the snap feature 170.

Although the present invention has been described in detail, modifications within the spirit and scope of the invention will be apparent to those skilled in the art. It should be understood that various aspects of the present invention and portions of the various embodiments and various features described above and/or in the appended claims may be combined or interchanged either in whole or in part. In the foregoing description of various embodiments, those embodiments that refer to another embodiment may be combined as appropriate with other embodiments as will be understood by those skilled in the art. Furthermore, those skilled in the art will appreciate that the foregoing description is by way of example only, and is not intended to limit the invention.

Claims

1. A wearable non-liquid drug injection device, comprising:

a housing defining a chamber having a first end and a second end;

a piston disposed toward a first end of the chamber and translatable within the chamber;

a hollow needle disposed within the chamber and extending from a front face of the piston toward the second end of the chamber;

an energetic material disposed within the first end of the chamber and behind the piston to force the piston and the hollow needle toward the second end of the chamber in response to activation of the energetic material;

a spring disposed within the chamber and extending from a front face of the piston toward a second end of the chamber; and

a drug strip disposed within the hollow needle and comprising an injectable substance.

2. The wearable non-liquid drug injection device of claim 1, wherein the drug band comprises one or more polymers and the injectable substance is in a non-liquid form that is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed within the one or more polymers.

3. The wearable non-liquid drug injection device of claim 2, further comprising a rear hub attached to an end of the drug band and disposed within the chamber and in front of the piston.

4. The wearable non-liquid drug injection device of claim 3, further comprising a snap feature disposed at the second end of the chamber, wherein the snap feature comprises a mating structure that engages the rear hub and locks the rear hub in position at the second end of the chamber once the piston is forced toward the second end of the chamber in response to activation of the energetic material.

5. The wearable non-liquid drug injection device of claim 1 or 2, further comprising:

an opening in the housing to an external environment; and

a needle guide defining a curved path that forces the hollow needle to bend toward the opening.

6. The wearable non-liquid drug injection device of claim 1 or 2, further comprising a reusable portion comprising: a starting circuit and a receiver, wherein the starting circuit is connectable to the energetic material and configured to activate the energetic material upon receiving an activation command from the receiver.

7. A wearable non-liquid drug injection device, comprising:

a first portion including a start circuit; and

a second portion connected to the first portion and comprising:

a chamber;

a piston disposed within the chamber;

a needle disposed within the chamber on a first side of the piston;

an energetic material disposed within the chamber on the second side of the piston and connected to the firing circuit;

a spring disposed within a chamber on a first side of the piston; and

a drug strip disposed within the needle, wherein the drug strip comprises an injectable substance in a non-liquid form.

8. The wearable non-liquid drug injection device of claim 7, wherein the first portion further comprises a battery and one or more capacitors, the battery is configured to store charge in the one or more capacitors, and the activation circuit is configured to: (i) activating the energetic material by coupling the one or more capacitors to an activator in contact with the energetic material, and (ii) releasing the stored charge and initiating an exothermic reaction of the energetic material.

9. The wearable non-liquid drug injection device of claim 7, wherein the drug band comprises one or more polymers and the injectable substance is at least one of: (i) disposed on a surface of the one or more polymers, and (ii) absorbed within the one or more polymers.

10. The wearable non-liquid drug injection device of claim 7, 8 or 9, wherein the injectable substance comprises epinephrine or glucagon.

11. The wearable non-liquid drug injection device of claim 7, 8 or 9, further comprising a rear hub attached to an end of the drug strip and disposed within the chamber on the first side of the piston.

12. The wearable non-liquid drug injection device of claim 11, further comprising a snap feature disposed within a chamber on a first side of the piston, wherein the snap feature comprises a mating structure that engages and locks the rear hub in place once the piston is forced through the chamber in response to activation of the energetic material.

13. The wearable non-liquid drug injection device of claim 7, 8 or 9, further comprising:

an opening in the second portion to an external environment; and

a needle guide defining a curved path that forces the needle to bend toward the opening, wherein the needle comprises a hollow tube having one tip with an opening.