WO2018213543A1 - Système d'injection automatique planaire - Google Patents

Système d'injection automatique planaire Download PDF

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Publication number
WO2018213543A1
WO2018213543A1 PCT/US2018/033134 US2018033134W WO2018213543A1 WO 2018213543 A1 WO2018213543 A1 WO 2018213543A1 US 2018033134 W US2018033134 W US 2018033134W WO 2018213543 A1 WO2018213543 A1 WO 2018213543A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
energy storage
housing
storage unit
medicament
Prior art date
Application number
PCT/US2018/033134
Other languages
English (en)
Inventor
Christopher Joseph KUEHN
Original Assignee
Kuehn Christopher Joseph
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 Kuehn Christopher Joseph filed Critical Kuehn Christopher Joseph
Publication of WO2018213543A1 publication Critical patent/WO2018213543A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users

Definitions

  • This document relates generally to needle-injection, and more particularly, but not by way of limitation, to planar auto-injection systems, apparatus, and methods.
  • An automatic Needle-Injection System (NIS), often referred to as auto- injector or an auto-injector system, is a device designed for the
  • NIS neurodegenerative medicine
  • drugs can be administered through an NIS, including, for example, anti-opiates, antitoxins, anti-venoms, emergency glucose medication for diabetics, emergency doses of epinephrine as a treatment for acute anaphylaxis, etc.
  • Auto-injectors typically include one of two types of auto-injection systems: a cartridge injection system, or a syringe injection system.
  • a needle component is usually manufactured separately from the medicament storage container, such as a glass or plastic syringe, and, upon activation of the auto-injector, the needle component punctures a seal in the medicament storage container, opening fluid
  • the needle component is often manufactured in direct contact with a primary container, and a medicament does not flow until pressurized by an energy storage member.
  • Each primary auto-injection system has benefits and drawbacks.
  • One drawback is standardization of the mechanisms used to move or pressurize a medicament storage container within an auto-injector.
  • a lack of differentiation between primary containers or medicament storage containers has led to the stagnation of new designs of auto-injectors.
  • Auto-injectors using these standard primary containers or medicament storage containers are generally large and cylindrical to incorporate the standard container held within, and are not intuitive to use or easily carried by users that need them within arm's reach at all times.
  • Custom sizes and shapes of primary containers and medicament storage containers were once difficult to manufacture; however, recent innovations in materials science, molding capabilities, and sealing technologies have enabled auto-injector manufacturers to create viable custom-shaped primary containers and medicament storage containers, for example, smaller than current models, substantially in one axis, without sacrificing mechanical or compatibility requirements of clinically- studied auto-injectors.
  • This document discusses, among other things, systems, apparatus, and methods including an apparatus having a housing, a needle movable from a first position wherein the needle is contained within the housing to a second position wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing, multiple energy storage units to aid injection of a medicament through the needle, including a first energy storage unit to drive the needle and a second energy storage unit to pressurize and expel a medication from a medicament storage container, and an actuation mechanism configured to actuate the multiple energy storage units.
  • the housing can include a visible window through which the needle can be viewed in the first position prior to injection. Methods of forming such apparatus are disclosed, as well as systems including such apparatus, methods of operation, and other embodiments.
  • FIG. 1 illustrates an isometric view of a Needle-Injection System (NIS) in a stored state having a safety cover.
  • NIS Needle-Injection System
  • FIG. 2 illustrates an isometric view of an NIS after a safety cover has been removed.
  • FIG. 3 illustrates an open -face view of an NIS including a mechanical detainment system to hold the multiple energy storage units in armed positions.
  • FIG. 4 illustrates an isometric, open-faced view of an NIS including a mechanical detainment system in a post-activation state.
  • FIG. 5 illustrates a sectional view of a fluid containment unit and injection system in a stored state.
  • FIG. 6 illustrates a top-down sectional view of a fluid containment unit and injection system in an activated state.
  • FIG. 7 illustrates an NIS including a visible window through which a needle can be viewed in a first position prior to injection.
  • the present inventors have recognized, among other things, systems, apparatus, and methods for providing accurate dosage delivery with an apparatus having a substantially planar form, for example, using multiple energy storage mechanisms, in certain examples, actuated in a single actuation, substantially simultaneously.
  • the planar auto-injection system can include a housing having a visible window through which a needle can be viewed, allowing a user to easily acquire the location of the needle prior to injection, improving device safety and compliance.
  • the planar auto-injection system can include a relatively flat primary container, smaller than s traditional Needle-Injection Systems (NIS).
  • NIS Needle-Injection Systems
  • a first energy storage unit can drive a needle from a first position, where the needle is located entirely within the primary container, to a second position, where at least a portion of the needle (e.g., a portion of the needle for insertion into tissue) is located outside of the primary container.
  • a second energy storage unit e.g., one or more spring-drive plungers, etc.
  • the multiple energy storage units provide a number of advantages, including enabling smaller actuation force (e.g., thinner, smaller springs, etc.) in contrast to a single energy storage unit configured to apply force to a needle and to a medicament storage container. Separate first and second energy storage units also enable different forces to be applied to the needle and to the medicament storage container. Further, a single actuation mechanism can trigger the multiple energy storage units at the same time, simplifying actuation and delivery of the medicament, and in certain examples, enabling a slimmer, smaller profile of the housing.
  • actuation force e.g., thinner, smaller springs, etc.
  • the planar auto-injection system can include a sterility mechanism that allows for the use of a non-standard fluid path from a medicament storage container to a cannula.
  • a fluid communication channel can couple the medicament storage container to a channel in the needle.
  • the communication channel can contain a seal to prevent fluid flow from the medicament storage container to the needle until the auto-injection apparatus is intentionally activated.
  • the seal can include a set of O-rings surrounding a cylinder that acts as an on/off fluid switch.
  • the seal can include a frangible seal that configured to be punctured to enable fluid communication.
  • the compartmentalized auto-injection apparatus can include a needle cover (e.g., a sharps protection unit) that can automatically extend to cover an extended needle.
  • the needle cover and housing of the compartmentalized auto- injection device can include features for intuitive and mistake-proof activation, including one or more of chamfered edges along the contact surface, one or more abutments on the needle cover to indicate needle port location, flanges or on the housing to dictate where a user's fingers should be located, or a grip-free needle guard design.
  • a standard injection procedure of an auto-injection device may contain three or four steps. First, remove any outer protective casing, which can protect the device from mechanical stresses during storage, and ensure an unused device. Second, remove any safety units, such as a safety pin or tab, protecting against accidental or unintended activation. Third, position the injector at a proper, intended injection site. Fourth, activate the device, either by placing pressure on the distal end of the device (e.g., a needle end of the device) or by using a separate activation button, lever, or other actuator positioned elsewhere on the device.
  • FIG. 1 illustrates an isometric view of an example Needle-Injection System (NIS) in a stored state having a safety cap 3.
  • the NIS can include two sections of housing, a top housing 1 and a bottom housing 2.
  • the housing can contain components within, and can be held together by fasteners 8, snap features, or one or more other mechanisms.
  • the housing can include grips on three of the four major edges, first and second lateral edges 4, and a proximal edge 5 (e.g., opposite the distal end where the needle exits at activation).
  • the housing can include flanges 6 to aid hand placement or application of force for a user.
  • the grips can extend all the way around the first and second lateral edges 4 and the proximal edge 5 of the NIS.
  • the safety cap 3 can cover a needle guard 7 and an actuation mechanism, and can include grips 9 to aid in removal of the safety cap 3 from the NIS. When the safety cap 3 is in place, it can keep the user from accidentally activating the NIS.
  • FIG. 2 illustrates an isometric view of an example NIS with a safety cap 3 removed.
  • the safety cap 3 can be removed from a side of the NIS, and can be coupled to the NIS using a detent system and groove 12 on the needle guard 7.
  • a feature of the safety cap 3, such as a shoulder or other mechanical feature, when attached to the needle guard 7, can prohibit activation of the NIS, or movement of the needle guard and actuation mechanism.
  • the needle guard 7 and a surface 11 of an actuation mechanism can be pressed against a user, and activated, deploying a needle through a needle port 10, such as to inject a medicament or other substance into a user.
  • FIG. 3 illustrates an open-face view of an example NIS including a mechanical detainment system to hold multiple energy storage units in armed positions in a pre-activation state.
  • the NIS can include an energy storage mechanism and an actuation mechanism.
  • the energy storage mechanism can include two springs compressed by an arming bar 13 along spring guide rods 16.
  • an arming screw 14 and anchoring nut 15 can provide a system that aids in arming the springs and holding them in place throughout the useful life of the device.
  • the first energy storage unit can include a first spring
  • the second energy storage unit can include a second spring.
  • the first and second springs can apply the same force, or apply separate forces to drive the needle and pressurize and expel the stored medication.
  • the actuation mechanism can include one or more flippers 19 and pins 18 configured to retain first and second rods 17 (e.g., a plunger rod and a needle rod, etc.) and contain the first and second springs.
  • the actuation mechanism can include one or more other mechanical actuators configured to retain or release one or more rods or springs.
  • FIG. 4 illustrates an isometric, open-faced view of an example NIS including a mechanical detainment system in a post-activation state.
  • the needle guard 7 can be compressed by the user to activate the NIS, sliding actuation rods 21 towards the proximal end of the housing, aligning actuation slots 20 on the actuation rods 21 with the flippers 19, allowing the flippers to displace the energy storage mechanism to move the plunger and needle rods 17 to their activated position, extending a needle 23 and expelling the medication from a medicament storage container 24.
  • FIG. 5 illustrates a sectional view of a fluid containment unit and injection system in a stored state, including a sterility closure mechanism to contain a fluid line in a sterile condition over the life cycle of an NIS.
  • the medicament storage container 24 can be closed off using a side cap 25, stopper 26, and set of o-rings 28.
  • the needle 23 can be kept sterile by a sterility sheath 22.
  • the sterility sheath 22 can be welded on to the medicament storage container 24.
  • the o-rings 28 can be kept in place by caps 30 on the proximal and distal end of the storage container.
  • a fluid communication port 27, which facilitates flow of the medication to the needle 23, can be held within the sterility sheath 22 for sterile storage.
  • FIG. 6 illustrates a top-down sectional view of a fluid containment unit and injection system in an activated state.
  • the plunger and needle rods 17 can be forced by the energy storage mechanism into positions that force the needle 23 out of the distal end of the housing through the needle port 10 and pressurize the medicament using the stopper 26 through the fluid communication port 27 which is now in line with a chamber of the medicament storage container 24 after passing a seal of the o-rings 28.
  • FIG. 7 illustrates an example NIS including a visible window through which a needle 23 can be viewed in a first position prior to injection activation or injection.
  • the needle guard 7, a clear window 31, and a needle sterility cover 32 that keeps the needle 23 sterile until injection can be translucent or near translucent to assist the user in identifying the location of the needle 23 in the NIS.
  • Method examples described herein can be machine or computer-implemented at least in part. Some examples may include a computer- readable medium or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform methods as described in the above examples.
  • An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.
  • An example (e.g., "Example 1”) of subject matter can include a housing; a needle movable from a first position, wherein the needle is contained within the housing, to a second position, wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing; a medicament storage container in fluid communication with the needle in the second position; multiple energy storage units to aid injection of a medicament through the needle, including a first energy storage unit to drive the needle and a second energy storage unit to pressurize and expel a medication from the medicament storage container; and an actuation mechanism configured to actuate the multiple energy storage units.
  • Example 2 the subject matter of Example 1 can optionally be configured such that the actuation mechanism includes a single actuator to actuate the multiple energy storage units.
  • Example 3 the subject matter of any one or more of Examples 1-2 can optionally be configured such that the actuation mechanism is configured to actuate the first and second energy storage mechanisms simultaneously.
  • Example 4 the subject matter of any one or more of Examples 1-3 can optionally be configured such that that the first energy storage unit includes a first spring configured to apply a first force and a second energy storage unit includes a second spring configured to apply a second force, and the first energy storage unit is separate from the second energy storage unit.
  • Example 5 the subject matter of any one or more of Examples 1-4 can optionally be configured such that the actuation mechanism includes first and second flippers configured to release the multiple energy storage units, a plunger rod, and a needle rod.
  • Example 6 the subject matter of any one or more of Examples 1-5 can optionally be configured such that the housing includes a visible window through which the distal end of the needle is visible in the first position prior to injection, or prior to driving the needle to the second position.
  • Example 7 the subject matter of any one or more of Examples 1-6 can optionally be configured such that the housing has a length along a first axis, a width along a second axis perpendicular to the first axis, and a thickness along a third axis perpendicular to the first and second axes, wherein the thickness is smaller than the width, and wherein the width is smaller than the length.
  • Example 8 the subject matter of any one or more of Examples 1-7 can optionally be configured such that the thickness is smaller than the width by at least a factor of 2, and smaller than the length by at least a factor of 3.
  • Example 9 the subject matter of any one or more of Examples 1-8 can optionally be configured such that the thickness is smaller than the width by at least a factor of 4, and smaller than the length by at least a factor of 6.
  • Example 10 the subject matter of any one or more of Examples 1- 9 can optionally be configured to include grips on a proximal edge of the housing and on first and second lateral edges of the housing.
  • An example (e.g., "Example 11") of subject matter can include: driving a needle from a first position, wherein the needle is contained within a housing, to a second position, wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing, using a first energy storage unit; pressurizing and expelling a medication from a medicament storage container in fluid communication with the needle in the second position using a second energy storage unit; and actuating the first and second energy storage units using an actuation mechanism configured to actuate the multiple energy storage units.
  • Example 12 the subject matter of Example 11 can optionally be configured such that actuating the first and second energy storage units includes simultaneously actuating a first spring configured to apply a first force and a second spring configured to apply a second force using a single actuator, wherein the first energy storage unit is separate from the second energy storage unit.
  • Example 13 the subject matter of any one or more of Examples 1- 12 can optionally be configured such that actuating the first and second energy storage units includes simultaneously releasing first and second flippers to release the first energy storage unit and a plunger rod, and the second energy storage unit and a needle rod.
  • Example 14 the subject matter of any one or more of Examples 1- 13 can optionally be configured such that the housing includes a visible window through which the distal end of the needle is visible in the first position prior to injection, or prior to driving the needle to the second position.
  • Example 15 the subject matter of any one or more of Examples 1- 14 can optionally be configured to include grips on a proximal edge of the housing and on first and second lateral edges of the housing.
  • An example (e.g., "Example 16") of subject matter can include: a housing; and a needle movable from a first position, wherein the needle is contained within the housing, to a second position, wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing, wherein the housing includes a visible window through which the distal end of the needle is visible in the first position prior to injection.
  • Example 17 the subject matter of Example 16 can optionally be configured to include a medicament storage container in fluid communication with the needle in the second position; multiple energy storage units to aid injection of a medicament through the needle, including a first energy storage unit to drive the needle and a second energy storage unit to pressurize and expel a medication from the medicament storage container; and an actuation mechanism configured to actuate the multiple energy storage units.
  • An example (e.g., "Example 18") of subject matter can include: driving a needle from a first position, wherein the needle is contained within a housing, to a second position, wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing, using a first energy storage unit, wherein the housing includes a visible window through which the distal end of the needle is visible in the first position prior to driving the needle to the second position.
  • Example 19 the subject matter of Example 18 can optionally be configured to include: pressurizing and expelling a medication from a medicament storage container in fluid communication with the needle in the second position using a second energy storage unit; and actuating the first and second energy storage units using an actuation mechanism configured to actuate the multiple energy storage units.
  • An example (e.g., "Example 20") of subject matter can include: a housing; a needle movable from a first position, wherein the needle is contained within the housing, to a second position, wherein a proximal end of the needle is within the housing and a distal end of the needle is outside of the housing; and grips on a proximal edge of the housing and on first and second lateral edges of the housing.
  • Example 21 the subject matter of Example 20 can optionally be configured to include a medicament storage container in fluid communication with the needle in the second position; multiple energy storage units to aid injection of a medicament through the needle, including a first energy storage unit to drive the needle and a second energy storage unit to pressurize and expel a medication from the medicament storage container; and an actuation mechanism configured to actuate the multiple energy storage units.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne, entre autres, des systèmes, un appareil et des procédés comprenant un appareil ayant un boîtier, une aiguille mobile depuis une première position dans laquelle l'aiguille est contenue à l'intérieur du boîtier vers une seconde position dans laquelle une extrémité proximale de l'aiguille se trouve à l'intérieur du boîtier et une extrémité distale de l'aiguille est à l'extérieur du boîtier, de multiples unités de stockage d'énergie pour aider à l'injection d'un médicament à travers l'aiguille, comprenant une première unité de stockage d'énergie pour entraîner l'aiguille et une seconde unité de stockage d'énergie pour mettre sous pression et expulser un médicament d'un récipient de stockage de médicament, et un mécanisme d'actionnement configuré pour actionner les multiples unités de stockage d'énergie. L'invention concerne également des procédés de formation d'un tel appareil, ainsi que des systèmes comprenant un tel appareil, des procédés de fonctionnement et d'autres modes de réalisation.
PCT/US2018/033134 2017-05-18 2018-05-17 Système d'injection automatique planaire WO2018213543A1 (fr)

Applications Claiming Priority (2)

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US201762507956P 2017-05-18 2017-05-18
US62/507,956 2017-05-18

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WO2018213543A1 true WO2018213543A1 (fr) 2018-11-22

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2058020A2 (fr) * 2005-02-01 2009-05-13 Intelliject, LLC Dispositifs, systèmes et procédés pour l'administration de médicaments
WO2016160341A1 (fr) * 2015-04-03 2016-10-06 Adrenacard Inc. Système d'auto-injection compartimenté

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2058020A2 (fr) * 2005-02-01 2009-05-13 Intelliject, LLC Dispositifs, systèmes et procédés pour l'administration de médicaments
WO2016160341A1 (fr) * 2015-04-03 2016-10-06 Adrenacard Inc. Système d'auto-injection compartimenté

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