WO2023187799A1 - Reusable drug delivery device - Google Patents

Reusable drug delivery device Download PDF

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Publication number
WO2023187799A1
WO2023187799A1 PCT/IN2022/050795 IN2022050795W WO2023187799A1 WO 2023187799 A1 WO2023187799 A1 WO 2023187799A1 IN 2022050795 W IN2022050795 W IN 2022050795W WO 2023187799 A1 WO2023187799 A1 WO 2023187799A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug delivery
delivery device
needle
injection
reusable drug
Prior art date
Application number
PCT/IN2022/050795
Other languages
French (fr)
Inventor
Arjun B S
Ajay Krishnan A
Adithya Kumar
Paramesh H
Hardik Jeetendra Pandya
Original Assignee
Indian Institute Of Science
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Indian Institute Of Science filed Critical Indian Institute Of Science
Publication of WO2023187799A1 publication Critical patent/WO2023187799A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159Dose expelling manners
    • A61M5/31591Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M2005/3142Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3553Range remote, e.g. between patient's home and doctor's office
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission

Definitions

  • Anaphylaxis or anaphylactic shock is a severe condition that is caused due to an allergic reaction due to a substance from which a person is allergic. It may occur within a few seconds or a couple of minutes from the exposure of the allergic substance onto the patient’s body. It generally results in release of a flood of chemicals that may lead to a person to experience a variety of conditions during such an allergic reaction. For example, the blood pressure of the target person may drop accompanied with the narrowing of the airway of the throat thereby, restricting the ability to breathe. Thus, high mortality and morbidity are observed for anaphylactic shocks and therefore, it leads to thousands of deaths each year. Statistically, it has been observed that adults between the ages of 20-40 years and especially, females are more prone to having anaphylaxis.
  • epinephrine also known as adrenaline injections are administered into the muscle of the patient to treat anaphylaxis.
  • epinephrine is a sympathomimetic catecholamine that exerts its pharmacologic effects on both alpha and beta- adrenergic receptors. It has a dose dependent response on alpha and beta receptors that leads to different pharmacological effects in the body that aids the muscles in the airways to relax and tightens the blood vessels of the patient, thereby increasing the blood pressure.
  • the patient may be placed in a reclining position such that their feet is elevated through which normal blood flow within the body may be restored.
  • FIG.1 illustrates a reusable drug delivery device for delivering a drug to a patient, as per one implementation of the present invention
  • FIG. 2 illustrates an exploded view of a reusable drug delivery device, as per one implementation of the present invention
  • FIG. 3 illustrates an electronic module accommodated inside a reusable drug delivery device for sending a distress signal to emergency service nodes, as per one implementation of the present invention
  • FIG. 4 illustrates a method for using a reusable drug delivery device for delivery a drug to a patient, as per one implementation of the present invention
  • FIGS. 5 illustrates a method for dissembling a reusable drug delivery device for replacing a syringe unit, as per one implementation of the present invention.
  • Epinephrine auto-injector are devices that usually come with a preloaded amount of epinephrine, and they also have a mechanism that is already activated to inject the patient with the drug when it is used. In a crisis, the use of such auto-injectors is preferred over manual drug injection by the patient as they provide better results and might ensure effective treatment.
  • the existing mechanism for these auto-injectors is single use in nature and therefore, they may not be reused or reactivated by the users.
  • Such devices do not provide any mechanism to replace the expired drugs.
  • Such devices usually come with pre-filled proprietary syringes that makes it difficult for a user to replace the expired drugs using relatively cheaper generic drugs available in pharmacy outlets or other alternative.
  • the device will have to be replaced, leading to a recurring economic burden to the end-users and this also causes environmental pollution as well.
  • the reusable drug delivery device may operate interchangeably between a deactivated state and an actuated state to be used to deliver the drug such as, but not limited to, epinephrine to the patient.
  • a deactivated state the device is ready for administering the drug, and once it transitioned to actuated state, the drug present inside the device may get administered.
  • the present example of drug, i.e., epinephrine is only indicative and other examples of drugs may also be used without deviating from the scope of the present subject matter.
  • the reusable drug delivery device may include a hollow top casing and a hollow bottom casing.
  • the hollow top casing further includes a first end and a second end, and the hollow bottom casing includes a needle injection end.
  • Examples of shapes of the hollow top casing include, but may not be limited to, cylindrical, spherical, cuboidal, cubical, etc. The present set of examples of shapes is only indicative. Other examples of shapes may also be used without deviating from the scope of the present subject matter.
  • the first end of the hollow top casing is provided with a safety cap.
  • the safety cap is moveable between a first position (closed state) and a second position (open state).
  • the hollow top casing further accommodates an injection mechanism slider longitudinally extending through it.
  • the injection mechanism slider includes a first closed end to be popped up from the first end of the hollow top casing and a second open end. Through this second open end, the injection mechanism slider allows insertion of an injection mechanism holder and when inserted, the injection mechanism holder compresses a button spring which is present inside the injection mechanism slider.
  • the injection mechanism holder may further include an injection spring and a syringe accommodated inside it. The syringe accommodated inside the reusable drug delivery device, when in the deactivated state, may compress the injection spring, which on actuation retracts to its original position causing the syringe to move out of the device to administer the drug.
  • the reusable drug delivery device further includes a retraction mechanism holder including a longitudinally extending hollow opening.
  • the retraction mechanism holder further includes an outer surface which accommodates a needle retraction spring and a needle retractor.
  • Each and every component of reusable drug delivery device as described herein may be manufactured using any medical grade material such as but not limited to polypropylene, polyethylene, nylon, polyether-ether-ketone (PEEK), etc., among other possible medical grade materials.
  • PEEK polyether-ether-ketone
  • non-medical grade materials may also be used to fabricate the components such as but not limited to rubber, metal, polymers, etc., among other possible materials may be used as well.
  • the reusable drug delivery device may include other components as well within its structure without deviating from the scope of the invention, which may be described in detail in accompanying figures.
  • the reusable drug delivery device implementing the claimed subject matter may be used for the auto administration or injection of any drug in a solution (liquid) form subcutaneously (under the skin) or intramuscularly (into the muscle).
  • the patient may use this reusable drug delivery device (hereafter, referred as device) to inject epinephrine into their muscle through their skin surface and treat their symptoms.
  • device reusable drug delivery device
  • the patient or any medical service provider places and presses the device onto a position, such as any part of the body, where the drug needs to be administered.
  • a patient needs to administer epinephrine into their thigh muscles to ensure proper treatment.
  • the patient may open the safety cap provided at the first end of the hollow top casing of the device to expose the first closed end of the injection mechanism slider (which works as an actuator for actuating the device).
  • the patient may actuate the device by pressing the top closed end of the injection mechanism slider to trigger movement of syringe.
  • a syringe may move from its resting position and is pushed outward from the device towards the delivery site.
  • the button spring which is compressed in deactivated state retracts to its original form causing the injection mechanism holder to move.
  • the injection spring accommodated inside the injection mechanism holder moves causing the syringe connected to it to move towards a needle injection end.
  • the needle of the syringe moves outside from the needle injection end, penetrating the muscle of the patient at the desired delivery site.
  • its movement may be restricted by a stopper, and the drug may be delivered to the muscle.
  • a stopper there is a plunger attached between the injection spring and the syringe which may get pushed due to the retraction of the injection spring to its original state.
  • restrictive force from the stopper and the push provided by the plunger lead to delivery of the drug into the thigh or any desired drug delivery site.
  • the amount of drug that is present inside the syringe that needs to be administered into the patient may be calculated beforehand and may be compensated in the design of the device.
  • the needle retractor may pop or moves outwards from the needle injection end to cover the exposed needle.
  • the needle retraction spring which gets compressed by the needle retractor while applying pressure during administration of drug, may retracts to its original state on releasing the pressure. This retraction of needle retraction spring pushes the needle retractor outwards to cover the exposed needle of the syringe. This will act as a needle retraction mechanism. Therefore, ensuring the safe operation of the device and reducing the likelihood of injuries due to an exposed needle.
  • an electronic module accommodated inside the device may be configured or adapted to transmit a distress signal to the emergency response numbers or emergency service nodes in the locality of the patient.
  • this signal may include the patient’s geo-location data and patient medical details.
  • Such transmission of distress signal with location data and patient data facilitates identification of patient’s health by the emergency service nodes.
  • One of the main disadvantages of the conventional devices is their one-time or single usage, to overcome this the present device has been made reusable. To reuse the device, the top part of the device is unscrewed from the bottom part of the device to replace the old syringe from within with a new one and the device again changes its state to the deactivated state.
  • the patients may replace the syringe with an expired drug with a new drug.
  • this may be done by opening the casing of the device followed by removing the expired drug and replacing it with a new one.
  • FIG. 1 illustrates a reusable drug delivery device 100 for delivering a drug to a patient, as per one implementation of the present invention.
  • the reusable drug delivery device 100 may be depicted in the form of a cylindrical pipe alike a pen however, this should not be constructed as a limitation. This depiction should be construed as one of possible physical implementation of the reusable drug delivery device 100 among variety of possible implementations such as a cubical or cuboidal device, spherical device, etc.
  • the reusable drug delivery device 100 (hereinafter, referred to as device 100) may include a hollow top casing 102 and a hollow bottom casing 104.
  • the hollow top casing 102 and the hollow bottom casing 104 form the outer body of the device 100.
  • all the mechanical and electrical components of the device 100 may be placed within the hollow top casing 102 and the hollow bottom casing 104.
  • the hollow top casing 102 include a first end 106 and a second end 108 and the hollow bottom casing 104 include a needle injection end 1 10.
  • a syringe provided in the device 100 comes out from the needle injection end 1 10.
  • the needle injection end 1 10 may be placed against the desired drug delivery site such that when the device 100 is activated or actuated, the needle emerging from the needle injection end 1 10 of the device 100 may inject the drug present in the syringe subcutaneously or intramuscularly to the patient.
  • the first end 106 of the hollow top casing 102 is further provided with a safety cap 1 12.
  • the safety cap 1 12 may provide the functionality of a safety lock that might prevent any accidental usage of the device 100.
  • the device 100 may not operate until and unless the safety cap 1 12 is either opened or removed from the first end 106 of the hollow top casing 102 of the device 100.
  • the safety cap 1 12 is either hinged, or coupled, or connected at the first end 106 of the hollow top casing 102.
  • the safety cap 1 12 is moveable between a first position (closed state) and a second position (open state).
  • first position closed state
  • second position open state
  • the safety cap 112 exposes an actuator for actuating a syringe unit present inside the device 100.
  • the safety cap 1 12 when flipped back to the first position is to cover the actuator to prevent inadvertent pressing of the actuator, thereby reducing the chances of false application of the drug at undesired sites.
  • the hinge mechanism illustrated in FIG. 2 allows reapplication of the safety cap 1 12 onto the first end 106 of the hollow top casing 102 enabling reusability of the device 100.
  • the safety cap 1 12 may be attached to the device 100 with the help of a friction fit as well.
  • above disclosed mechanism for connecting the safety cap 1 12 onto the first end 106 of the hollo top casing 102 provide single finger use mechanism to expose the actuator.
  • the above disclosed components or components which may be described later in the specification may be manufacture using any medical grade material such as but not limited to polypropylene, polyethylene, nylon, poly-ether-ether- ketone (PEEK), etc., among other possible medical grade materials.
  • PEEK poly-ether-ether- ketone
  • non-medical grade materials may also be used to fabricate different components of the device 100 such as but not limited to rubber, metal, polymers, etc., among other possible materials may be used as well.
  • the hollow top casing 102 of the device 100 may further include a drug inspection slot 1 14.
  • the drug inspection slot 1 14 may be implemented as a cut out or opening in the hollow top casing 102 of the device 100, such that it enables the patient to check whether the drug present inside the hollo top casing 102 is expired/degraded/used or not.
  • this drug inspection slot 1 14 may also enable the patient to check the quantity and quality of drug available in the device 100, thereby making it easier to recognize whether the device 100 can be used or not.
  • the drug inspection slot 1 14 may be carved onto the outer surface of the hollow top casing 102 providing a view to the user to check application status of the drug present inside the syringe.
  • FIG. 2 illustrates an exploded view of the reusable drug delivery device 200, as per one implementation of the present invention.
  • the reusable drug delivery device 200 (hereafter, referred to as device 200) may be similar to that of device 100 as described in FIG. 1 .
  • the device 200 may also include the hollow top casing 102, hollow bottom casing 104, safety cap 1 12 and drug inspection slot 1 14.
  • device 200 may include an injection mechanism slider 202 which may be enclosed inside the hollow top casing 102.
  • the injection mechanism slider 202 includes a hollow opening longitudinally extending between a first closed end 204 and a second open end 206.
  • the shape of the injection mechanism slider 202 is same as that of the hollow top casing 102, but its dimensions are so adjusted that it is accommodated inside the hollow top casing 102 and is moveable to and from inside the hollow top casing 102.
  • the hollow top casing 102 is such designed that it encloses a portion of the injection mechanism slider 202.
  • the device 200 may further include an injection mechanism holder 208 to be accommodated inside the injection mechanism slider 202.
  • the injection mechanism holder 208 includes a bottom portion 210 and an extension member 212 extending longitudinally from the bottom portion 210.
  • the bottom portion 210 of the injection mechanism holder 208 is threaded like a screw.
  • the injection mechanism holder 208 when accommodated onto the injection mechanism slider 202, is to cause the extension member 212 of the injection mechanism holder 208 to pass into the hollow opening of the injection mechanism slider 202.
  • the injection mechanism slider 202 further accommodates a button spring 228.
  • the injection mechanism holder 208 compresses the button spring 228 against the first closed end 204 of the injection mechanism slider 202.
  • the device 200 may further include a syringe 216 housed or accommodated inside the injection mechanism holder 208.
  • the syringe 216 is attached to a syringe holder 218 which combinedly referred to as a syringe unit 214.
  • the syringe unit 214 When the device 200 is in deactivated state, the syringe unit 214 is accommodated into a plunger 230 which in turn is attached to an injection spring 220.
  • the syringe unit 214, the plunger 230 and the injection spring 220 may be collectively referred to as a needle mechanism.
  • the needle mechanism when accommodated inside the injection mechanism holder 208 causes the injection spring 220 to get compressed by the combination of plunger 230 and the syringe unit 214.
  • the device 200 further includes an injection retraction mechanism.
  • the injection retraction mechanism includes a retraction mechanism holder 222, a needle retraction spring 224 and a needle retractor 226.
  • the retraction mechanism holder 222 further includes a longitudinally extending hollow opening and an outer surface, wherein the outer surface further accommodates the needle retraction spring 224 which subsequently followed by the needle retractor 226.
  • the hollow bottom casing 104 including the needle injection end 1 10 accommodates or encloses the retraction mechanism holder 222, the needle retraction spring 224 and the needle retractor 226.
  • the device 200 may further include a stopper such as a sleeve spring 232 positioned at the end of the needle retractor 226 near to the needle injection end 1 10.
  • the sleeve spring 232 restricts the movement of the syringe holder 218 beyond the needle injection end 1 10. For example, on actuation, the syringe unit 214 of the device 200 moves towards the needle injection end 1 10 due to the retraction of the button spring 228 and injection spring 220.
  • the plunger 230 attached to one of the ends of the syringe unit 214 is pushed further to administer the drug comprised in the syringe 216 intramuscularly through the desired drug delivery site.
  • the device 200 may further include an electronic module (not shown in FIG. 2) which may generate and release a distress signal to inform the emergency services in the patient’s locality.
  • the distress signal may include the patient’s location and other medical details.
  • the emergency services include, but may not be limited to, nearby hospitals, clinics, and dispensary. Such transmission of distress signal informs the nearby emergency service nodes about the status of the patient, and if data present in the distress signal represent severe condition, the emergency service node may reach the patient to provide all possible medical attention and treatment. In view of this, there is no requirement for the patient to reach nearby emergency service node itself and reduces chances of mortality in case of server health conditions.
  • FIG. 3 illustrates a reusable drug delivery device (either device 100 or device 200) including an electronic module 302 for sending a distress signal to emergency service nodes, as per one implementation of the present invention.
  • the electronic module 302 (referred hereafter as module 302) is implemented in a reusable drug delivery device, such as device 100 or 200 as per the present disclosure.
  • the module 302 may further include a processing unit 304 and a memory 306.
  • the module 302 may further include other components, such as interfaces to communicate over the network or with external storage or computing devices, display, input/output interfaces, operating systems, applications, data, and the like, which have not been described here for brevity.
  • the processing unit 304 may include a processor(s).
  • the processor may be implemented as a dedicated processor, a shared processor, or a plurality of individual processors, some of which may be shared.
  • the processor may fetch and execute computer-readable instructions, from a machine-readable storage medium (not shown in FIG. 3 for brevity).
  • the machine-readable storage medium may include non-transitory computer-readable medium including, for example, volatile memory such as RAM (Random Access Memory), or nonvolatile memory such as EPROM (Erasable Programmable Read Only Memory), flash memory, and the like.
  • the processing unit 304 may be implemented as a microprocessor, microcomputer, microcontroller, digital signal processor, central processing unit, state machine, logic circuitry, and/or any device that may manipulate signals based on operational instructions.
  • the processing unit 304 may be a single computational unit or may include multiple such computational units, without deviating from the scope of the present subject matter.
  • the memory 306 may include any computer-readable medium known in the art including, for example, volatile memory, such as Static Random-Access Memory (SRAM) and Dynamic Random-Access Memory (DRAM), and/or non-volatile memory, such as Read-Only Memory (ROM), Erasable Programmable ROMs (EPROMs), flash memories, hard disks, optical disks, and magnetic tapes.
  • volatile memory such as Static Random-Access Memory (SRAM) and Dynamic Random-Access Memory (DRAM)
  • non-volatile memory such as Read-Only Memory (ROM), Erasable Programmable ROMs (EPROMs), flash memories, hard disks, optical disks
  • the module 302 may also be connected to a central emergency service server or a centralized server (not shown here for the sake of brevity) over a network.
  • the network may be a private network or a public network and may be implemented as a wired network (such as but not limited to optical fiber), a wireless network, or a combination of a wired and wireless network.
  • the network may also include a collection of individual networks, interconnected with each other and functioning as a single large network, such as the Internet.
  • GSM Global System for Mobile Communication
  • UMTS Universal Mobile Telecommunications System
  • PCS Personal Communications Service
  • TDMA Time Division Multiple Access
  • CDMA Code Division Multiple Access
  • NTN Next Generation Network
  • PSTN Public Switched Telephone Network
  • LTE Long Term Evolution
  • ISDN Integrated Services Digital Network
  • the module 302 may further include units 308 and data 310.
  • the units 308 may be implemented as a combination of hardware and programming resources, for example, programmable instructions to implement a variety of functionalities of the units 308.
  • such combinations of hardware and programming resources may be implemented in several different ways.
  • the units 308 when implemented as a hardware, may be a microcontroller, embedded controller, or super l/O-based integrated circuits.
  • the programming for the units 308 may be executable instructions. Such instructions may be stored on a non- transitory machine-readable storage medium which may be coupled either directly with the module 302 or indirectly (for example, through networked means).
  • the units 308 may include a processing resource, for example, either a single processor or a combination of multiple processors, to execute such instructions.
  • the non- transitory machine-readable storage medium may store instructions that, when executed by the processing resource, implement units 308.
  • the units 308 may be implemented as electronic circuitry.
  • the units 308 in turn may include a geo-location unit 312, a transmission unit 314 and other unit(s) 316.
  • the other unit(s) 316 may implement functionalities that supplement applications or functions performed by the module 302 or any of the units 308.
  • the data 310 includes data that is either stored or generated as a result of functionalities implemented by any of the units 308 of the module 302. It may be further noted that information stored and available in the data 310 may be utilized by the units 308 for performing various functions by the module 302.
  • data 310 may include a geo-location data 318, a patient data 320 and other data 322.
  • Such different data 310 may be utilized for performing various functions, as will be described below.
  • the present approaches may be applicable to other examples without deviating from the scope of the present subject matter.
  • the blocks representing units 308 and data 310 are indicated as being within the module 302 for the sake of explanation only. Any one or more blocks within units 308 and data 310 may be implemented as separate blocks outside the module 302, with the different functional blocks being utilized for sending a distress signal to the emergency services or centralized locations for further processing of the collected data, as will be described further below.
  • the module 302 may send a distress signal to emergency service nodes (not shown in FIG. 3) present nearby patient.
  • the generation of distress signal is based on the assessment of the patient’s location by the geo-location unit 312 and is being transmitted to the nearby emergency service nodes using the transmission unit 314.
  • the geo-location unit 312 may determine the location of the patient.
  • the geo-location unit 312 may utilize satellite navigation to locate the patient.
  • the determination of the location may be done using one of or a plurality of systems such as but not limited to Global Positioning System (GPS), Global Navigation Satellite system (GLONASS), BeiDou, Galileo positioning system, Navigation with Indian Constellation (NavIC) and Quasi-Zenith Satellite System (QZSS) among other possible positioning systems or technologies.
  • GPS Global Positioning System
  • GLONASS Global Navigation Satellite system
  • NavIC Navigation with Indian Constellation
  • QZSS Quasi-Zenith Satellite System
  • the geo-location unit 312 may save the location of the patient as geo-location data 318 and share it with the nearby emergency service node.
  • the transmission unit 314 may also be coupled to a central emergency service server (not shown in FIG. 3) which in turn is connected to emergency service nodes.
  • the transmission unit 314 may share the distress signal with the emergency service nodes.
  • the distress signal includes geo-location data 318 of the patient and other patient data 320 may also be included in the distress signal.
  • the patient data 320 include information pertaining to the identity of the patient and or other historical medically relevant information.
  • the transmission unit 314 may determine the emergency service nodes that are available in the patient’s locality and may only share the distress signal with identified nodes to ensure that timely assistance is provided to the patient without wasting medical resources. In certain scenarios, the condition of the patient may be critical and it wouldn’t be possible for the patient to travel to the emergency service nodes on its own. In such cases, sharing the distress signal by the module 302 with the emergency service nodes as soon as the patient injects themselves with the drug allows the patient to receive timely medical assistance.
  • FIG. 4 illustrates an exemplary method 400 for injecting a drug inside the muscle of a patient using a reusable drug delivery device, as per one implementation of the present invention.
  • the method 400 may be implemented in a variety of medical devices, for the ease of explanation, the present description of the example method 400 is provided in reference to the above-described reusable drug delivery device 100 and 200 (collectively referred to as device 100, 200). It is pertinent to note that the order in which the method 400 is described is not intended to be construed as a limitation, and any number of the described method steps may combine in any order to implement the method 400, or an alternative method. It may be understood that the steps of the method 400 may be performed by the device 100, 200.
  • a reusable drug delivery device such as device 100 or device 200 may be grasped and placed near the desired drug delivery site of the patient.
  • Such grasping and positioning of the device 100, 200 may be performed by the patient itself or by a medical service provider (which for bring clarity is referenced hereafter as a user).
  • a medical service provider which for bring clarity is referenced hereafter as a user.
  • the user needs to administer epinephrine into their thigh muscles to ensure proper treatment.
  • the device 100, 200 may be grasped using a single hand ensuring little or no difficulty to the user while administering the drug to the patient.
  • the user touches and presses the device 100, 200 onto the desired drug delivery site, in present case it is thighs of the user.
  • the needle retractor 226 pushed upwards which in turn compresses the needle retraction spring 224.
  • such compression helps the needle retraction spring 224 to store an amount of energy which on retraction forces the needle retractor 226 to come out of the device 100, 200.
  • the above described pressing of the device 100, 200 ensures erect position while administering the drug which eventually helps in efficient application of drug.
  • the user may open or remove the safety cap 1 12 of the device 100, 200.
  • the user may simply use their thumb of a hand in which the device 100, 200 is grasped to flip the safety cap 1 12 and disengage the safety lock of the device 100, 200.
  • the safety cap 1 12 is moveable between the first position and the second position and when flipped from first position to the second position, exposes the first closed end 204 of the injection mechanism slider 202 which on pressing activates the syringe unit to administer the drug to the patient.
  • this safety cap 1 12 allows the device 100, 200 to be used single handedly while ensuring safety against unintended use, thereby making it easier for patient to administer the drug to the user.
  • the user may press the actuator for actuating the device 100, 200.
  • the first closed end 204 of the injection mechanism slider 202 is popped out of the first end 106.
  • the device 100, 200 gets actuated enabling movement of the syringe unit 214 out of the device 100, 200 through the needle injection end 1 10.
  • the button spring 228 gets retracted to its original form which in turn pushes the injection mechanism holder 208 towards the needle injection end 1 10.
  • injection mechanism holder 208 causes the injection spring 220 to gets retracted to its original form which in turn further pushes the syringe unit 214 along with the plunger 230 towards the needle injection end 1 10. Due to such movement of syringe unit 214, the needle of the syringe 216 gets intramuscularly inserted inside the thigh of the user.
  • the syringe holder 218 is restricted by the sleeve spring 232 near the needle injection end 110 thereby, allowing the plunger 230 to push further the needle of the syringe 216 to intramuscularly administer the drug into the thigh of the user.
  • the user may release the pressure which is applied on the device 100, 200 while delivering the drug.
  • the user may either releases the pressure or pulls the device 100, 200 back away from the desired drug delivery site.
  • the needle retractor 226 comes out of the from the needle injection end 1 10 covering the exposed needle of the syringe 216.
  • pressure is applied on the device 100, 200 which in turn compresses the needle retraction spring 224.
  • the needle retraction spring 224 gets retracted to its original form, pushing the needle retractor 226 to come out of the needle injection end 110, thereby covering the exposed needle to prevent any injuries that may occur due to an exposed needle.
  • the user closes or flips the safety cap 1 12 back to the first position.
  • the user may flip the safety cap 1 12 to the first position to close the first end 106 of the hollow top casing 102, thereby preventing future inadvertent actuation of the device 100, 200.
  • FIG. 5 illustrates a method 500 for dissembling a reusable drug delivery device for replacing a syringe unit, as per one implementation of the present invention.
  • the method 500 may be implemented in a variety of medical devices, for the ease of explanation, the present description of the example method 500 is provided in reference to the above-described reusable drug delivery device 100 and 200 (collectively referred to as device 100, 200). It is pertinent to note that the order in which the method 500 is described is not intended to be construed as a limitation, and any number of the described method steps may combine in any order form to implement the method 500, or an alternative method. It may be understood that the steps of the method 500 may be performed by the device 100, 200.
  • a reusable drug delivery device such as device 100, 200, accommodated with a dose of drug is shown.
  • This device 100, 200 is used by any patient or any medical service provider to administer the drug to the patient by actuating the syringe unit 214.
  • a used reusable drug delivery device is shown. As shown in step 504, the drug present inside the device 100, 200 is administered and the needle retractor 226 is actuated to cover the exposed needle.
  • the device may be opened to become two or more separate units (as shown in step 506). These units maybe attached together to form the assembled device using a threaded joint or other reusable joining techniques. These individual units house the needle injection mechanism, needle retraction mechanism, syringe with drug, safety cap etc. As shown in FIG. 5, the device 100, 200 is dissembled to open the device 100, 200.
  • the dissembled device as shown in step 506 includes a top unit 510, a syringe unit 512 and a bottom unit 514. In an example, similar to device as described in FIG. 1 and FIG.
  • the top unit 510 includes hollow top casing 102, safety cap 112, injection mechanism slider 202, button spring 228, injection mechanism holder 208, and injection spring 220.
  • the syringe unit 512 includes syringe 216 and syringe holder 218.
  • the bottom unit 514 includes hollow bottom casing 104, retraction mechanism holder 222, needle retraction spring 224, needle retractor 226 and sleeve spring 232.
  • the retraction mechanism holder 222 comprised in the bottom unit 514 is a threaded end for enabling locking of the retraction mechanism holder 222 with the injection mechanism holder 208 of the top unit 510 to form a closed structure.
  • the bottom portion 210 of the injection mechanism holder 208 is complimentarily threaded with respect to the threaded end of the retraction mechanism holder 222 to get locked with the retraction mechanism holder 222.
  • the reassembled reusable drug delivery device 100, 200 includes a new syringe, such as syringe 216, which may be replaced due to its inefficiency or it may be used.

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Abstract

Examples of a reusable drug delivery device (100, 200) and a method (400) of using the reusable drug delivery device (100, 200) for delivering a drug to a patient are described. The reusable drug delivery device (100, 200) may include a hollow top casing (102) including a first end (106) with a safety and a second end (108). The hollo top casing (102) encloses an injection mechanism slider (202), an injection mechanism holder (208), an injection spring (220), and a button spring (228). The reusable drug delivery device (100, 200) may further include a hollow bottom casing (104) which encloses a retraction mechanism holder (222), a needle retraction spring (224), and a needle retractor (226). The reusable drug delivery device (100, 200) further includes a syringe unit (214) comprising a syringe (216) and a syringe holder (218).

Description

REUSEABLE DRUG DELIVERY DEVICE
BACKGROUND
[0001] Anaphylaxis or anaphylactic shock is a severe condition that is caused due to an allergic reaction due to a substance from which a person is allergic. It may occur within a few seconds or a couple of minutes from the exposure of the allergic substance onto the patient’s body. It generally results in release of a flood of chemicals that may lead to a person to experience a variety of conditions during such an allergic reaction. For example, the blood pressure of the target person may drop accompanied with the narrowing of the airway of the throat thereby, restricting the ability to breathe. Thus, high mortality and morbidity are observed for anaphylactic shocks and therefore, it leads to thousands of deaths each year. Statistically, it has been observed that adults between the ages of 20-40 years and especially, females are more prone to having anaphylaxis.
[0002] Conventionally, epinephrine (also known as adrenaline) injections are administered into the muscle of the patient to treat anaphylaxis. As may be understood, epinephrine is a sympathomimetic catecholamine that exerts its pharmacologic effects on both alpha and beta- adrenergic receptors. It has a dose dependent response on alpha and beta receptors that leads to different pharmacological effects in the body that aids the muscles in the airways to relax and tightens the blood vessels of the patient, thereby increasing the blood pressure. Further, the patient may be placed in a reclining position such that their feet is elevated through which normal blood flow within the body may be restored.
BRIEF DESCRIPTION OF FIGURES
[0003] The detailed description is provided with reference to the accompanying figures, wherein:
[0004] FIG.1 illustrates a reusable drug delivery device for delivering a drug to a patient, as per one implementation of the present invention; [0005] FIG. 2 illustrates an exploded view of a reusable drug delivery device, as per one implementation of the present invention;
[0006] FIG. 3 illustrates an electronic module accommodated inside a reusable drug delivery device for sending a distress signal to emergency service nodes, as per one implementation of the present invention;
[0007] FIG. 4 illustrates a method for using a reusable drug delivery device for delivery a drug to a patient, as per one implementation of the present invention; and
[0008] FIGS. 5 illustrates a method for dissembling a reusable drug delivery device for replacing a syringe unit, as per one implementation of the present invention.
[0009] Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements. The figures are not necessarily to scale, and the size of some parts may be exaggerated to more clearly illustrate the example shown. Moreover, the drawings provide examples and/or implementations consistent with the description; however, the description is not limited to the examples and/or implementations provided in the drawings.
DETAILED DESCRIPTION
[0010] Various devices and methods may be used for treating anaphylaxis. The most common treatment protocol suggested to people with a history of anaphylaxis involves carrying an epinephrine auto-injector. Epinephrine auto-injector are devices that usually come with a preloaded amount of epinephrine, and they also have a mechanism that is already activated to inject the patient with the drug when it is used. In a crisis, the use of such auto-injectors is preferred over manual drug injection by the patient as they provide better results and might ensure effective treatment. [0011] However, the existing mechanism for these auto-injectors is single use in nature and therefore, they may not be reused or reactivated by the users. Further, such devices do not provide any mechanism to replace the expired drugs. Such devices usually come with pre-filled proprietary syringes that makes it difficult for a user to replace the expired drugs using relatively cheaper generic drugs available in pharmacy outlets or other alternative. Hence, irrespective of the condition of the auto-injector, i.e., used or not used, the device will have to be replaced, leading to a recurring economic burden to the end-users and this also causes environmental pollution as well.
[0012] Furthermore, users need to be trained regarding the proper use of the auto-injectors. According to studies, unintentional injections are accidently delivered to a finger or thumb around 90% of the time. These cause intense pain locally but usually completely resolve in some time. The cause of unintentional injections has been attributed to design flaws, where the device is mistaken for a pen or the user mistakes which end of the device contains the needle. To prevent this unintentional use, conventional autoinjectors usually come with safety mechanisms to prevent accidental injections while carrying the device. Here, it is pertinent to note that these mechanisms may often require two hands to be operated. However, considering the vulnerability of the patient under anaphylaxis, a safety mechanism or a safety lock that is single hand operated is desired.
[0013] Examples of a reusable drug delivery device and a method of using the reusable drug delivery device for delivering a drug to a patient are described. The present subject matter may be utilized to overcome the above-mentioned technical disadvantages which are present with respect to the prior auto-injector devices. In an example, the reusable drug delivery device may operate interchangeably between a deactivated state and an actuated state to be used to deliver the drug such as, but not limited to, epinephrine to the patient. For example, in deactivated state, the device is ready for administering the drug, and once it transitioned to actuated state, the drug present inside the device may get administered. The present example of drug, i.e., epinephrine, is only indicative and other examples of drugs may also be used without deviating from the scope of the present subject matter.
[0014] The reusable drug delivery device may include a hollow top casing and a hollow bottom casing. The hollow top casing further includes a first end and a second end, and the hollow bottom casing includes a needle injection end. Examples of shapes of the hollow top casing include, but may not be limited to, cylindrical, spherical, cuboidal, cubical, etc. The present set of examples of shapes is only indicative. Other examples of shapes may also be used without deviating from the scope of the present subject matter.
[0015] The first end of the hollow top casing is provided with a safety cap. In an example, the safety cap is moveable between a first position (closed state) and a second position (open state). The hollow top casing further accommodates an injection mechanism slider longitudinally extending through it. In an example, the injection mechanism slider includes a first closed end to be popped up from the first end of the hollow top casing and a second open end. Through this second open end, the injection mechanism slider allows insertion of an injection mechanism holder and when inserted, the injection mechanism holder compresses a button spring which is present inside the injection mechanism slider. The injection mechanism holder may further include an injection spring and a syringe accommodated inside it. The syringe accommodated inside the reusable drug delivery device, when in the deactivated state, may compress the injection spring, which on actuation retracts to its original position causing the syringe to move out of the device to administer the drug.
[0016] The reusable drug delivery device further includes a retraction mechanism holder including a longitudinally extending hollow opening. The retraction mechanism holder further includes an outer surface which accommodates a needle retraction spring and a needle retractor. Each and every component of reusable drug delivery device as described herein may be manufactured using any medical grade material such as but not limited to polypropylene, polyethylene, nylon, polyether-ether-ketone (PEEK), etc., among other possible medical grade materials. In an example, non-medical grade materials may also be used to fabricate the components such as but not limited to rubber, metal, polymers, etc., among other possible materials may be used as well. It may be further noted that, the reusable drug delivery device may include other components as well within its structure without deviating from the scope of the invention, which may be described in detail in accompanying figures. As may be evident to a person skilled in the art, the reusable drug delivery device implementing the claimed subject matter may be used for the auto administration or injection of any drug in a solution (liquid) form subcutaneously (under the skin) or intramuscularly (into the muscle).
[0017] In operation, on the onset of an allergic reaction, the patient may use this reusable drug delivery device (hereafter, referred as device) to inject epinephrine into their muscle through their skin surface and treat their symptoms. In an example, initially, the patient or any medical service provider places and presses the device onto a position, such as any part of the body, where the drug needs to be administered. For example, during anaphylaxis as per medical studies, a patient needs to administer epinephrine into their thigh muscles to ensure proper treatment. Once the device is pressed, the patient may open the safety cap provided at the first end of the hollow top casing of the device to expose the first closed end of the injection mechanism slider (which works as an actuator for actuating the device).
[0018] Thereafter, the patient may actuate the device by pressing the top closed end of the injection mechanism slider to trigger movement of syringe. In an example, when the actuator is pressed by the patient, a syringe may move from its resting position and is pushed outward from the device towards the delivery site. In one example, on actuating the device, the button spring which is compressed in deactivated state retracts to its original form causing the injection mechanism holder to move. In response to the movement of injection mechanism holder, the injection spring accommodated inside the injection mechanism holder moves causing the syringe connected to it to move towards a needle injection end.
[0019] As a result of such relative motion of different components of the device, the needle of the syringe moves outside from the needle injection end, penetrating the muscle of the patient at the desired delivery site. Further, once the syringe has moved a predefined distance, its movement may be restricted by a stopper, and the drug may be delivered to the muscle. For example, there is a plunger attached between the injection spring and the syringe which may get pushed due to the retraction of the injection spring to its original state. Hence, restrictive force from the stopper and the push provided by the plunger lead to delivery of the drug into the thigh or any desired drug delivery site.
[0020] In one example, the amount of drug that is present inside the syringe that needs to be administered into the patient may be calculated beforehand and may be compensated in the design of the device. After the delivery of the drug, as soon as the pressure applied on the thigh by the device is released, the needle retractor may pop or moves outwards from the needle injection end to cover the exposed needle. In an example, the needle retraction spring which gets compressed by the needle retractor while applying pressure during administration of drug, may retracts to its original state on releasing the pressure. This retraction of needle retraction spring pushes the needle retractor outwards to cover the exposed needle of the syringe. This will act as a needle retraction mechanism. Therefore, ensuring the safe operation of the device and reducing the likelihood of injuries due to an exposed needle.
[0021] Returning to present example, after delivering the drug to a patient, an electronic module accommodated inside the device may be configured or adapted to transmit a distress signal to the emergency response numbers or emergency service nodes in the locality of the patient. In an example, this signal may include the patient’s geo-location data and patient medical details. Such transmission of distress signal with location data and patient data facilitates identification of patient’s health by the emergency service nodes. One of the main disadvantages of the conventional devices is their one-time or single usage, to overcome this the present device has been made reusable. To reuse the device, the top part of the device is unscrewed from the bottom part of the device to replace the old syringe from within with a new one and the device again changes its state to the deactivated state. Therefore, in an example, the patients may replace the syringe with an expired drug with a new drug. In one example this may be done by opening the casing of the device followed by removing the expired drug and replacing it with a new one. These and other approaches are further described in conjunction with the accompanying figures, i.e., FIGS. 1 -5.
[0022] FIG. 1 illustrates a reusable drug delivery device 100 for delivering a drug to a patient, as per one implementation of the present invention. In the present example, although, the reusable drug delivery device 100 may be depicted in the form of a cylindrical pipe alike a pen however, this should not be constructed as a limitation. This depiction should be construed as one of possible physical implementation of the reusable drug delivery device 100 among variety of possible implementations such as a cubical or cuboidal device, spherical device, etc. [0023] The reusable drug delivery device 100 (hereinafter, referred to as device 100) may include a hollow top casing 102 and a hollow bottom casing 104. In an example, the hollow top casing 102 and the hollow bottom casing 104 form the outer body of the device 100. In one example, all the mechanical and electrical components of the device 100 may be placed within the hollow top casing 102 and the hollow bottom casing 104. The hollow top casing 102 include a first end 106 and a second end 108 and the hollow bottom casing 104 include a needle injection end 1 10. In an example, on actuating the device 100, a syringe provided in the device 100 comes out from the needle injection end 1 10. In an example, the needle injection end 1 10 may be placed against the desired drug delivery site such that when the device 100 is activated or actuated, the needle emerging from the needle injection end 1 10 of the device 100 may inject the drug present in the syringe subcutaneously or intramuscularly to the patient.
[0024] The first end 106 of the hollow top casing 102 is further provided with a safety cap 1 12. In an example, the safety cap 1 12 may provide the functionality of a safety lock that might prevent any accidental usage of the device 100. In one example, the device 100 may not operate until and unless the safety cap 1 12 is either opened or removed from the first end 106 of the hollow top casing 102 of the device 100.
[0025] In an example, the safety cap 1 12 is either hinged, or coupled, or connected at the first end 106 of the hollow top casing 102. The safety cap 1 12 is moveable between a first position (closed state) and a second position (open state). For example, on flipping the safety cap 1 12 from the first position to the second position, the safety cap 112 exposes an actuator for actuating a syringe unit present inside the device 100. On the other hand, the safety cap 1 12, when flipped back to the first position is to cover the actuator to prevent inadvertent pressing of the actuator, thereby reducing the chances of false application of the drug at undesired sites.
[0026] Thus, if a patient wishes to operate the device 100, they need to open or remove the safety cap 1 12 to expose the actuator for actuating the device 100. Example ways by which the safety cap 112 may be attached to the device 100 include, but may not be limited to, hinge mechanism, coupling mechanism, or any other possible way. In one example, the hinge mechanism (illustrated in FIG. 2) allows reapplication of the safety cap 1 12 onto the first end 106 of the hollow top casing 102 enabling reusability of the device 100.
[0027] In another example, the safety cap 1 12 may be attached to the device 100 with the help of a friction fit as well. Thus, to allow the device 100 to support single handed operation while ensuring the safety of the patient as well, above disclosed mechanism for connecting the safety cap 1 12 onto the first end 106 of the hollo top casing 102 provide single finger use mechanism to expose the actuator. In one example, the above disclosed components or components which may be described later in the specification may be manufacture using any medical grade material such as but not limited to polypropylene, polyethylene, nylon, poly-ether-ether- ketone (PEEK), etc., among other possible medical grade materials. In another example, non-medical grade materials may also be used to fabricate different components of the device 100 such as but not limited to rubber, metal, polymers, etc., among other possible materials may be used as well.
[0028] Returning to the present example, the hollow top casing 102 of the device 100 may further include a drug inspection slot 1 14. In an example, the drug inspection slot 1 14 may be implemented as a cut out or opening in the hollow top casing 102 of the device 100, such that it enables the patient to check whether the drug present inside the hollo top casing 102 is expired/degraded/used or not. In another example, this drug inspection slot 1 14 may also enable the patient to check the quantity and quality of drug available in the device 100, thereby making it easier to recognize whether the device 100 can be used or not. In another example, the drug inspection slot 1 14 may be carved onto the outer surface of the hollow top casing 102 providing a view to the user to check application status of the drug present inside the syringe.
[0029] FIG. 2 illustrates an exploded view of the reusable drug delivery device 200, as per one implementation of the present invention. In an example, the reusable drug delivery device 200 (hereafter, referred to as device 200) may be similar to that of device 100 as described in FIG. 1 . As described in FIG. 1 , the device 200 may also include the hollow top casing 102, hollow bottom casing 104, safety cap 1 12 and drug inspection slot 1 14. In addition to this, device 200 may include an injection mechanism slider 202 which may be enclosed inside the hollow top casing 102. The injection mechanism slider 202 includes a hollow opening longitudinally extending between a first closed end 204 and a second open end 206. In an example, the shape of the injection mechanism slider 202 is same as that of the hollow top casing 102, but its dimensions are so adjusted that it is accommodated inside the hollow top casing 102 and is moveable to and from inside the hollow top casing 102. In an example, the hollow top casing 102 is such designed that it encloses a portion of the injection mechanism slider 202. [0030] The device 200 may further include an injection mechanism holder 208 to be accommodated inside the injection mechanism slider 202. The injection mechanism holder 208 includes a bottom portion 210 and an extension member 212 extending longitudinally from the bottom portion 210. In one example, the bottom portion 210 of the injection mechanism holder 208 is threaded like a screw. In an example, the injection mechanism holder 208, when accommodated onto the injection mechanism slider 202, is to cause the extension member 212 of the injection mechanism holder 208 to pass into the hollow opening of the injection mechanism slider 202.
[0031] In one example, the injection mechanism slider 202 further accommodates a button spring 228. When the injection mechanism holder 208 is inserted inside the injection mechanism slider 202 and the device 200 is in a deactivated state, the injection mechanism holder 208 compresses the button spring 228 against the first closed end 204 of the injection mechanism slider 202. In addition, the device 200 may further include a syringe 216 housed or accommodated inside the injection mechanism holder 208. In an example, the syringe 216 is attached to a syringe holder 218 which combinedly referred to as a syringe unit 214.
[0032] When the device 200 is in deactivated state, the syringe unit 214 is accommodated into a plunger 230 which in turn is attached to an injection spring 220. In an example, the syringe unit 214, the plunger 230 and the injection spring 220 may be collectively referred to as a needle mechanism. The needle mechanism when accommodated inside the injection mechanism holder 208 causes the injection spring 220 to get compressed by the combination of plunger 230 and the syringe unit 214. After the syringe unit 214, the device 200 further includes an injection retraction mechanism. The injection retraction mechanism includes a retraction mechanism holder 222, a needle retraction spring 224 and a needle retractor 226. In an example, the retraction mechanism holder 222 further includes a longitudinally extending hollow opening and an outer surface, wherein the outer surface further accommodates the needle retraction spring 224 which subsequently followed by the needle retractor 226.
[0033] In an example, the hollow bottom casing 104 including the needle injection end 1 10 accommodates or encloses the retraction mechanism holder 222, the needle retraction spring 224 and the needle retractor 226. As describe above, the device 200 may further include a stopper such as a sleeve spring 232 positioned at the end of the needle retractor 226 near to the needle injection end 1 10. In an example, the sleeve spring 232 restricts the movement of the syringe holder 218 beyond the needle injection end 1 10. For example, on actuation, the syringe unit 214 of the device 200 moves towards the needle injection end 1 10 due to the retraction of the button spring 228 and injection spring 220. Such movement of the syringe unit 214 caused by retraction of button spring 228 and injection spring 220 is restricted by the sleeve spring 232. In addition, the plunger 230 attached to one of the ends of the syringe unit 214 is pushed further to administer the drug comprised in the syringe 216 intramuscularly through the desired drug delivery site.
[0034] The device 200 may further include an electronic module (not shown in FIG. 2) which may generate and release a distress signal to inform the emergency services in the patient’s locality. In an example, the distress signal may include the patient’s location and other medical details. In one example, the emergency services include, but may not be limited to, nearby hospitals, clinics, and dispensary. Such transmission of distress signal informs the nearby emergency service nodes about the status of the patient, and if data present in the distress signal represent severe condition, the emergency service node may reach the patient to provide all possible medical attention and treatment. In view of this, there is no requirement for the patient to reach nearby emergency service node itself and reduces chances of mortality in case of server health conditions.
[0035] FIG. 3 illustrates a reusable drug delivery device (either device 100 or device 200) including an electronic module 302 for sending a distress signal to emergency service nodes, as per one implementation of the present invention. The electronic module 302 (referred hereafter as module 302) is implemented in a reusable drug delivery device, such as device 100 or 200 as per the present disclosure. The module 302 may further include a processing unit 304 and a memory 306. Although not depicted, the module 302 may further include other components, such as interfaces to communicate over the network or with external storage or computing devices, display, input/output interfaces, operating systems, applications, data, and the like, which have not been described here for brevity.
[0036] The processing unit 304 may include a processor(s). The processor may be implemented as a dedicated processor, a shared processor, or a plurality of individual processors, some of which may be shared. Among other capabilities, the processor may fetch and execute computer-readable instructions, from a machine-readable storage medium (not shown in FIG. 3 for brevity). The machine-readable storage medium may include non-transitory computer-readable medium including, for example, volatile memory such as RAM (Random Access Memory), or nonvolatile memory such as EPROM (Erasable Programmable Read Only Memory), flash memory, and the like.
[0037] The processing unit 304 may be implemented as a microprocessor, microcomputer, microcontroller, digital signal processor, central processing unit, state machine, logic circuitry, and/or any device that may manipulate signals based on operational instructions. The processing unit 304 may be a single computational unit or may include multiple such computational units, without deviating from the scope of the present subject matter. [0038] The memory 306 may include any computer-readable medium known in the art including, for example, volatile memory, such as Static Random-Access Memory (SRAM) and Dynamic Random-Access Memory (DRAM), and/or non-volatile memory, such as Read-Only Memory (ROM), Erasable Programmable ROMs (EPROMs), flash memories, hard disks, optical disks, and magnetic tapes.
[0039] In one example, the module 302 may also be connected to a central emergency service server or a centralized server (not shown here for the sake of brevity) over a network. In such a case, the network may be a private network or a public network and may be implemented as a wired network (such as but not limited to optical fiber), a wireless network, or a combination of a wired and wireless network. The network may also include a collection of individual networks, interconnected with each other and functioning as a single large network, such as the Internet. Examples of such individual networks may include, but are not limited to, Global System for Mobile Communication (GSM) network, Universal Mobile Telecommunications System (UMTS) network, Personal Communications Service (PCS) network, Time Division Multiple Access (TDMA) network, Code Division Multiple Access (CDMA) network, Next Generation Network (NGN), Public Switched Telephone Network (PSTN), Long Term Evolution (LTE), and Integrated Services Digital Network (ISDN).
[0040] The module 302 may further include units 308 and data 310. The units 308 may be implemented as a combination of hardware and programming resources, for example, programmable instructions to implement a variety of functionalities of the units 308. In examples described herein, such combinations of hardware and programming resources may be implemented in several different ways. For example, when implemented as a hardware, the units 308 may be a microcontroller, embedded controller, or super l/O-based integrated circuits. The programming for the units 308 may be executable instructions. Such instructions may be stored on a non- transitory machine-readable storage medium which may be coupled either directly with the module 302 or indirectly (for example, through networked means). In an example, the units 308 may include a processing resource, for example, either a single processor or a combination of multiple processors, to execute such instructions. In the present examples, the non- transitory machine-readable storage medium may store instructions that, when executed by the processing resource, implement units 308. In other examples, the units 308 may be implemented as electronic circuitry.
[0041] The units 308 in turn may include a geo-location unit 312, a transmission unit 314 and other unit(s) 316. The other unit(s) 316 may implement functionalities that supplement applications or functions performed by the module 302 or any of the units 308. The data 310, on the other hand, includes data that is either stored or generated as a result of functionalities implemented by any of the units 308 of the module 302. It may be further noted that information stored and available in the data 310 may be utilized by the units 308 for performing various functions by the module 302. In an example, data 310 may include a geo-location data 318, a patient data 320 and other data 322.
[0042] Such different data 310 may be utilized for performing various functions, as will be described below. The present approaches may be applicable to other examples without deviating from the scope of the present subject matter. It may be noted that the blocks representing units 308 and data 310 are indicated as being within the module 302 for the sake of explanation only. Any one or more blocks within units 308 and data 310 may be implemented as separate blocks outside the module 302, with the different functional blocks being utilized for sending a distress signal to the emergency services or centralized locations for further processing of the collected data, as will be described further below.
[0043] Once the patient administered the drug present inside the device 100 to the desired delivery site, the module 302 may send a distress signal to emergency service nodes (not shown in FIG. 3) present nearby patient. The generation of distress signal is based on the assessment of the patient’s location by the geo-location unit 312 and is being transmitted to the nearby emergency service nodes using the transmission unit 314. In the context of the present example, at first the geo-location unit 312 may determine the location of the patient. In an example, the geo-location unit 312 may utilize satellite navigation to locate the patient. In one example, the determination of the location may be done using one of or a plurality of systems such as but not limited to Global Positioning System (GPS), Global Navigation Satellite system (GLONASS), BeiDou, Galileo positioning system, Navigation with Indian Constellation (NavIC) and Quasi-Zenith Satellite System (QZSS) among other possible positioning systems or technologies. Other approaches for determining the position of the patient may also be used without deviating from the scope of the present subject matter. Returning to the present example, the geo-location unit 312 may save the location of the patient as geo-location data 318 and share it with the nearby emergency service node. In another example, the transmission unit 314 may also be coupled to a central emergency service server (not shown in FIG. 3) which in turn is connected to emergency service nodes.
[0044] Returning to the present example, the transmission unit 314 may share the distress signal with the emergency service nodes. In an example, the distress signal includes geo-location data 318 of the patient and other patient data 320 may also be included in the distress signal. The patient data 320, in one example, include information pertaining to the identity of the patient and or other historical medically relevant information. In yet another example, the transmission unit 314 may determine the emergency service nodes that are available in the patient’s locality and may only share the distress signal with identified nodes to ensure that timely assistance is provided to the patient without wasting medical resources. In certain scenarios, the condition of the patient may be critical and it wouldn’t be possible for the patient to travel to the emergency service nodes on its own. In such cases, sharing the distress signal by the module 302 with the emergency service nodes as soon as the patient injects themselves with the drug allows the patient to receive timely medical assistance.
[0045] FIG. 4 illustrates an exemplary method 400 for injecting a drug inside the muscle of a patient using a reusable drug delivery device, as per one implementation of the present invention. Although, the method 400 may be implemented in a variety of medical devices, for the ease of explanation, the present description of the example method 400 is provided in reference to the above-described reusable drug delivery device 100 and 200 (collectively referred to as device 100, 200). It is pertinent to note that the order in which the method 400 is described is not intended to be construed as a limitation, and any number of the described method steps may combine in any order to implement the method 400, or an alternative method. It may be understood that the steps of the method 400 may be performed by the device 100, 200.
[0046] At step 402, a reusable drug delivery device, such as device 100 or device 200 may be grasped and placed near the desired drug delivery site of the patient. Such grasping and positioning of the device 100, 200 may be performed by the patient itself or by a medical service provider (which for bring clarity is referenced hereafter as a user). As described above, during anaphylaxis as per medical studies, the user needs to administer epinephrine into their thigh muscles to ensure proper treatment. In an example, the device 100, 200 may be grasped using a single hand ensuring little or no difficulty to the user while administering the drug to the patient.
[0047] At step 404, the user touches and presses the device 100, 200 onto the desired drug delivery site, in present case it is thighs of the user. In response to pressing the device 100, 200, the needle retractor 226 pushed upwards which in turn compresses the needle retraction spring 224. In an example, such compression helps the needle retraction spring 224 to store an amount of energy which on retraction forces the needle retractor 226 to come out of the device 100, 200. The above described pressing of the device 100, 200 ensures erect position while administering the drug which eventually helps in efficient application of drug.
[0048] At step 406, the user may open or remove the safety cap 1 12 of the device 100, 200. For example, the user may simply use their thumb of a hand in which the device 100, 200 is grasped to flip the safety cap 1 12 and disengage the safety lock of the device 100, 200. In an example, as described above, the safety cap 1 12 is moveable between the first position and the second position and when flipped from first position to the second position, exposes the first closed end 204 of the injection mechanism slider 202 which on pressing activates the syringe unit to administer the drug to the patient. As may be understood, the use of this safety cap 1 12 allows the device 100, 200 to be used single handedly while ensuring safety against unintended use, thereby making it easier for patient to administer the drug to the user.
[0049] At step 408, the user may press the actuator for actuating the device 100, 200. For example, on flipping the safety cap 1 12 from the first end 106 of the hollow top casing 102, the first closed end 204 of the injection mechanism slider 202 is popped out of the first end 106. On pressing the first closed end 204, the device 100, 200 gets actuated enabling movement of the syringe unit 214 out of the device 100, 200 through the needle injection end 1 10. For example, on pressing the first closed end 204, initially, the button spring 228 gets retracted to its original form which in turn pushes the injection mechanism holder 208 towards the needle injection end 1 10.
[0050] Such movement of injection mechanism holder 208 causes the injection spring 220 to gets retracted to its original form which in turn further pushes the syringe unit 214 along with the plunger 230 towards the needle injection end 1 10. Due to such movement of syringe unit 214, the needle of the syringe 216 gets intramuscularly inserted inside the thigh of the user. As the syringe unit 214 and the plunger 230 attached with the injection spring 220 move outwards, the syringe holder 218 is restricted by the sleeve spring 232 near the needle injection end 110 thereby, allowing the plunger 230 to push further the needle of the syringe 216 to intramuscularly administer the drug into the thigh of the user.
[0051] At step 410, once the drug comprised in the device 100, 200 is administered or delivered, the user may release the pressure which is applied on the device 100, 200 while delivering the drug. In an example, to release the pressure, the user may either releases the pressure or pulls the device 100, 200 back away from the desired drug delivery site. In response to the released pressure, the needle retractor 226 comes out of the from the needle injection end 1 10 covering the exposed needle of the syringe 216. In one example, as described above in step 404, pressure is applied on the device 100, 200 which in turn compresses the needle retraction spring 224. On releasing such pressure, the needle retraction spring 224 gets retracted to its original form, pushing the needle retractor 226 to come out of the needle injection end 110, thereby covering the exposed needle to prevent any injuries that may occur due to an exposed needle.
[0052] At step 412, the user closes or flips the safety cap 1 12 back to the first position. For example, once the drug is administered and the needle retractor covers the exposed needle, the user may flip the safety cap 1 12 to the first position to close the first end 106 of the hollow top casing 102, thereby preventing future inadvertent actuation of the device 100, 200.
[0053] FIG. 5 illustrates a method 500 for dissembling a reusable drug delivery device for replacing a syringe unit, as per one implementation of the present invention. Although, the method 500 may be implemented in a variety of medical devices, for the ease of explanation, the present description of the example method 500 is provided in reference to the above-described reusable drug delivery device 100 and 200 (collectively referred to as device 100, 200). It is pertinent to note that the order in which the method 500 is described is not intended to be construed as a limitation, and any number of the described method steps may combine in any order form to implement the method 500, or an alternative method. It may be understood that the steps of the method 500 may be performed by the device 100, 200.
[0054] At step 502, a reusable drug delivery device, such as device 100, 200, accommodated with a dose of drug is shown. This device 100, 200 is used by any patient or any medical service provider to administer the drug to the patient by actuating the syringe unit 214.
[0055] At step 504, a used reusable drug delivery device is shown. As shown in step 504, the drug present inside the device 100, 200 is administered and the needle retractor 226 is actuated to cover the exposed needle.
[0056] Once the device is used, the device may be opened to become two or more separate units (as shown in step 506). These units maybe attached together to form the assembled device using a threaded joint or other reusable joining techniques. These individual units house the needle injection mechanism, needle retraction mechanism, syringe with drug, safety cap etc. As shown in FIG. 5, the device 100, 200 is dissembled to open the device 100, 200. The dissembled device as shown in step 506 includes a top unit 510, a syringe unit 512 and a bottom unit 514. In an example, similar to device as described in FIG. 1 and FIG. 2, the top unit 510 includes hollow top casing 102, safety cap 112, injection mechanism slider 202, button spring 228, injection mechanism holder 208, and injection spring 220. The syringe unit 512 includes syringe 216 and syringe holder 218. Further, the bottom unit 514 includes hollow bottom casing 104, retraction mechanism holder 222, needle retraction spring 224, needle retractor 226 and sleeve spring 232. Hence, after the drug is injected, the device may be opened into separate components, these individual parts then may be reset by assembling a new syringe in the syringe unit to reset the individual units to their initial configuration.
[0057] In an example, the retraction mechanism holder 222 comprised in the bottom unit 514 is a threaded end for enabling locking of the retraction mechanism holder 222 with the injection mechanism holder 208 of the top unit 510 to form a closed structure. As described above, the bottom portion 210 of the injection mechanism holder 208 is complimentarily threaded with respect to the threaded end of the retraction mechanism holder 222 to get locked with the retraction mechanism holder 222.
[0058] At step 508, a reassembled reusable drug delivery device is shown. The reassembled reusable drug delivery device 100, 200 includes a new syringe, such as syringe 216, which may be replaced due to its inefficiency or it may be used.
[0059] Although examples for the present disclosure have been described in the context of delivering epinephrine to treat anaphylaxis, it is pertinent to note that the present approach may be applied for injecting drugs subcutaneously or intramuscularly and for treating a plethora of other medical conditions as well. Other such examples would also be within the scope of the claimed subject matter.
[0060] Although examples for the present disclosure have been described in language specific to structural features and/or methods, it is to be understood that the appended claims are not necessarily limited to the specific features or methods described. Rather, the specific features and methods are disclosed and explained as examples of the present disclosure.

Claims

I/We Claim:
1 . A reusable drug delivery device (100) comprising: a hollow top casing (102) comprising a first end (106) and a second end (108); a safety cap (1 12) provided at the first end (106) of the hollow top casing (102); an injection mechanism slider (202) comprising a hollow opening longitudinally extending between a first closed end (204) and a second open end (206), wherein the injection mechanism slider (202) is shaped to be accommodated inside the hollow top casing (102); an injection mechanism holder (208) comprising: a bottom portion (210); an extension member (212) longitudinally extending from the bottom portion (210), wherein when the injection mechanism holder (208) is accommodated onto the injection mechanism slider (202) is to cause the extension member (212) to pass into the hollow opening of the injection mechanism slider (202); a syringe (216) to be accommodated inside the injection mechanism holder (208) and is to compress an injection spring (220) when the reusable drug delivery device (100) is in a deactivated state; a retraction mechanism holder (222) comprising a longitudinally extending hollow opening; a needle retraction spring (224) to be accommodated around an outer surface of the retraction mechanism holder (222); and a needle retractor (226) positioned next to the needle retraction spring (224) around the outer surface of the retraction mechanism holder (222).
2. The reusable drug delivery device (100) as claimed in claim 1 , wherein the injection mechanism slider (208) further accommodates a button spring (228), and wherein the button spring (228) is to be compressed, when the injection mechanism holder (208) is accommodated onto the injection mechanism slider (202) and the reusable drug delivery device (100) is in a deactivated state.
3. The reusable drug delivery device (100) as claimed in claim 1 , wherein the syringe (216) is attached to a syringe holder (218) forming a syringe unit (214), wherein the syringe unit (214) on inserting inside the injection mechanism holder (208) is accommodated into a plunger (230) which in turn is attached to the injection spring (220).
4. The reusable drug delivery device (100) as claimed in claim 1 , wherein the reusable drug delivery device (100) further comprises: a hollow bottom casing (104) comprising a needle injection end (1 10), wherein the hollow bottom casing (104) accommodates the retraction mechanism holder (222), the needle retraction spring (224) and the needle retractor (226); and a drug inspection slot (1 14) carved on to an outer surface of the hollow top casing (102) providing a view to check application status of the drug present inside the syringe unit (214).
5. The reusable drug delivery device (100) as claimed in claim 1 , wherein the reusable drug delivery device (100) further comprises a sleeve spring (232) accommodated inside the retraction mechanism holder (222) for restricting movement of the syringe holder (218) beyond the needle injection end (1 10) of the hollow bottom casing (104).
6. The reusable drug delivery device (100) as claimed in claim 1 , wherein the safety cap (1 12) is hinged, coupled, or connected at the first end (106) of the hollow top casing (102) and is moveable between a first position and a second position, and wherein the safety cap (1 12), when flipped from the first position to the second position, is to expose the first closed end (204) of the injection mechanism slider (202) for actuating the syringe unit (214).
7. The reusable drug delivery device (100) as claimed in claim 5, wherein, the safety cap (1 12), when in the first position is to cover the first end (106) of the hollow top casing (102) to prevent inadvertent pressing of the first closed end (204) of the injection mechanism slider (202).
8. The reusable drug delivery device (100) as claimed in claim 1 , wherein the reusable drug delivery device (100) is to switch from the deactivated state to an actuated state, when the first closed end (204) of the injection mechanism slider (202) is pressed.
9. The reusable drug delivery device (100) as claimed in claim 2 to 8, wherein the button spring (228) retracts from a compressed state to the decompressed state in response to pressing the first closed end (204) of the injection mechanism slider (202).
10. The reusable drug delivery device (100) as claimed in claim 9, wherein the button spring (228) on retracting to its decompressed state in response to pressing the first closed end (204) of the injection mechanism slider (202) is to further: move the injection mechanism holder (208) towards needle injection end (1 10), wherein the force generated due to the retraction of the button spring (228) causes the injection mechanism holder (208) to move towards needle injection end.
1 1. The reusable drug delivery device (100) as claimed in claim 10, wherein movement of the injection mechanism holder (208) is to further push the injection spring (220) which in response get retracted to its original position and enable movement of the syringe unit (214) towards the needle injection end (1 10).
12. The reusable drug delivery device (100) as claimed in claim 1 , wherein on touching and pressing the reusable drug delivery device (100) on a desired drug deliver site, the needle retractor (226) moves to compress the needle retraction spring (224).
13. The reusable drug delivery device (100) as claimed in claim 12, wherein on releasing the applied pressure, the needle retraction spring (224) retracts to decompressed state causing the needle retractor (226) to come out of the needle injection end (1 10) to cover a needle of the syringe unit (214) to prevent inadvertent touching of the needle while handling the reusable drug delivery device (100).
14. The reusable drug delivery device (100) as claimed in claim 1 , wherein the retraction mechanism holder (222) comprises a threaded end for enabling locking of the retraction mechanism holder (222) with the injection mechanism holder (208) to form a closed structure, wherein the bottom portion (210) of the injection mechanism holder (208) is complimentarily threaded with respect to the threaded end of the retraction mechanism holder (222) to get locked with the retraction mechanism holder (222).
15. The reusable drug delivery device (100) as claimed in claim 1 , wherein the reusable drug delivery device (100) further comprises an electronic module (302) for transmitting a distress signal to a centralized server, wherein the distress signal comprises a geo-location data (318) and a patient data (320).
PCT/IN2022/050795 2022-03-29 2022-09-06 Reusable drug delivery device WO2023187799A1 (en)

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IN202241018326 2022-03-29

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104602736A (en) * 2012-09-05 2015-05-06 爱康医学农业合作协会有限公司 Electronic auto-injection device
WO2021222908A1 (en) * 2020-05-01 2021-11-04 Koska Family Limited Medical injectors and systems and methods for an injection management platform

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104602736A (en) * 2012-09-05 2015-05-06 爱康医学农业合作协会有限公司 Electronic auto-injection device
WO2021222908A1 (en) * 2020-05-01 2021-11-04 Koska Family Limited Medical injectors and systems and methods for an injection management platform

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