JP6275615B2 - Self-injection device with needle cover with anti-start device - Google Patents

Self-injection device with needle cover with anti-start device Download PDF

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JP6275615B2
JP6275615B2 JP2014208091A JP2014208091A JP6275615B2 JP 6275615 B2 JP6275615 B2 JP 6275615B2 JP 2014208091 A JP2014208091 A JP 2014208091A JP 2014208091 A JP2014208091 A JP 2014208091A JP 6275615 B2 JP6275615 B2 JP 6275615B2
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portion
device
needle
reservoir
activation
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JP2015027567A (en
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クリステンセン コーリー
クリステンセン コーリー
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ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company
ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company
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    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A61M2005/14256Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means with means for preventing access to the needle after use
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14506Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons mechanically driven, e.g. spring or clockwork

Description

  The present invention relates generally to substance delivery devices with improved patient convenience, ease of use, and efficiency. The present invention also generally relates to patch-like stand-alone substance injection or self-injection devices that can be used to deliver a variety of substances or drugs to a patient. More particularly, the present invention relates to a patch-like infusion or self-injection device having a needle cover incorporating a selective activation prevention device.

  Many people, such as those suffering from diseases such as diabetes, use some form of infusion therapy, such as daily insulin infusions, to maintain close control of blood glucose levels. Currently, in the example of insulin infusion therapy, two main types of daily insulin therapy are performed. The first scheme includes a syringe and an insulin pen. These devices are simple to use and relatively low in cost, but usually require needle sticks after every 3 to 4 injections per day. The second scheme involves infusion pump therapy and requires the purchase of an expensive pump that will not be usable in about three years. The high cost (approximately 8 to 10 times the daily cost of syringe therapy) and limited pump life are major barriers for this type of therapy. Insulin pumps are also relatively old technology and very cumbersome to use. In addition, from a lifestyle standpoint, the tubing that connects the pump to the delivery point on the patient's abdomen (called the “infusion set”) is very inconvenient and these pumps are relatively heavy and carry the pump Is a burden. However, from the patient's point of view, the vast majority of patients who have used a pump prefer to continue using the pump for life. This is because infusion pumps are more complex than syringes and pens, but offer the advantage that insulin is infused continuously, administration is accurate, and delivery schedules can be programmed. As a result, glucose is more finely controlled and the sense of health is improved.

  With the development of pump therapy being observed and the increasing number of daily injections, there is growing interest in better therapies. In this and similar infusion examples, the best of daily injection therapy (low cost and ease of use) and insulin pump therapy (continuous infusion and accurate dosing) to fully meet this growing interest There is a need for an insulin delivery or infusion format that combines these features and avoids the respective drawbacks.

  Attempts have been made to provide a low cost and convenient to use or “wearable” drug infusion device. Some of these devices are intended to be partially or wholly disposable. Theoretically, this type of device can provide many of the advantages of an infusion pump without cost and inconvenience. Unfortunately, many of these devices suffer from patient discomfort (depending on the gauge and / or length of the needle used), between the substance being delivered and the material used within the structure of the infusion device. Compatibility and interaction, as well as inadequacies that can occur if not properly activated by the patient (eg, injection is “wet” as a result of premature device activation). In particular, when short and / or fine gauge needles are used, challenges in manufacturing and in controlling the penetration depth of the needle have also been faced. There has also been a problem of the possibility that a needle touching a person who contacts a used device may cause injury.

  Accordingly, there is a need for an alternative to current infusion devices such as infusion pumps for insulin that further simplify manufacturing and use improvements for insulin and non-insulin applications.

US Pat. No. 6,568,143 International Publication No. 02/083214 Pamphlet

Biochem Biophys Acta, 1989,67,1007; Rubins et al., Microbial Pathogenesis, 25, 337-342

  One aspect of the present invention is a patch-like injection or self-injection that allows for the injection of a desired substance and can be conveniently worn against the skin while minimizing discomfort by using one or more microneedles. Is to provide a device. An additional aspect of the present invention is to provide such an infusion or self-injection device that prevents premature activation of the infusion or self-injection device.

  The above and / or other aspects of the present invention include a body in which a reservoir for containing a medicament is disposed, and an injection needle that penetrates the patient's skin, the pathway for the medicament between the reservoir and the patient This is accomplished by providing a drug delivery device that includes a needle that provides The device is also placed in the body and moves from the pre-activated position to the activated position to activate the device, and covers the syringe needle to prevent the rotor from moving and preventing the device from starting Needle cover.

  The above and / or other aspects of the present invention are also realized by providing a drug delivery device that includes a body in which a reservoir for containing a medicament is disposed and an injection needle that penetrates the patient's skin. The device also includes a needle cover having a first portion that covers the needle and a second portion that can be moved from a first position that prevents activation of the device to a second position that allows activation of the device. including.

  The above and / or other aspects of the present invention also include a body having a reservoir for containing a pharmaceutical product and a rotor rotatably disposed within the body, wherein the device is activated when the rotor rotates. This is accomplished by providing a drug delivery device that includes a rotating rotor and a needle that penetrates the patient's skin and that provides a path for the medication between the reservoir and the patient. The device also includes a needle cover that covers the injection needle and a needle cover clip that is disposed on the needle cover and that rotates from a first position that prevents rotation of the rotor to a second position that allows rotation of the rotor. Including.

  The above and / or other aspects of the present invention also provide a drug delivery device having a body in which a reservoir for containing a pharmaceutical product is disposed, a rotor that activates the device, and an injection needle that penetrates the patient's skin. This is accomplished by providing a method for controlling activation. In this method, a needle cover is disposed on the injection needle of the device, and a portion of the needle cover that is located outside the device body is rotated into the opening of the device body, and the rotor is engaged with the rotor. Preventing the motor from rotating to the activated position.

  Additional and / or other aspects and advantages of the present invention will be set forth in part in the description which follows, and in part will be apparent from the description, or may be learned from practice of the invention.

The above and / or other aspects and advantages of embodiments of the present invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings.
1 is a perspective view of one embodiment of a patch-like infusion or self-injection device in a pre-activated state prior to activation. FIG. FIG. 2 is a partially exploded view of the injection device of FIG. 1 in a pre-activated state. FIG. 2 is a partially exploded view of the infusion device of FIG. 1 in a pre-activated state with the actuator button rotated away to show further details. FIG. 2 is a more detailed exploded view of the infusion device of FIG. 1 in a pre-activated state. FIG. 2 is a cross-sectional view of the infusion device of FIG. 1 in a pre-activated state. FIG. 2 is a cross-sectional view of the infusion device of FIG. 1 in a pre-activated state with the activator button rotated away. FIG. 2 is a partially exploded view of the injection device of FIG. 1 during installation of a safety mechanism. FIG. 2 is a partially exploded view of the injection device of FIG. 1 after activation. FIG. 2 is a more detailed exploded view of the injection device of FIG. 1 after activation. FIG. 2 is a cross-sectional view of the injection device of FIG. 1 after activation. FIG. 2 is a partially exploded view of the injection device of FIG. 1 after placement of the safety mechanism. FIG. 2 is a cross-sectional view of the injection device of FIG. 1 after placement of the safety mechanism. It is a figure which shows the bottom face of a safety mechanism. It is a figure which further shows the structure of a safety mechanism. It is a figure which shows the administration completion indicator in the injection | pouring device of FIG. 1, and its operation | movement. It is a figure which shows the administration completion indicator in the injection | pouring device of FIG. 1, and its operation | movement. It is a figure which shows the administration completion indicator in the injection | pouring device of FIG. 1, and its operation | movement. It is a figure which shows the administration completion indicator in the injection | pouring device of FIG. 1, and its operation | movement. FIG. 3 shows an embodiment of an injection device having an injection port. FIG. 2 shows one embodiment of a rotor in the injection device of FIG. FIG. 2 shows a needle cover in the injection device of FIG. It is a figure which shows interaction of each rotor of FIG. 17 and FIG. 18, and a needle | hook cover. FIG. 2 is a perspective view of one embodiment of a needle cover clip in the injection device of FIG. FIG. 2 is a side view of one embodiment of a needle cover clip within the injection device of FIG. 1. FIG. 2 is a perspective view of one embodiment of a rotor in the injection device of FIG. 1. FIG. 2 is a perspective view of one embodiment of a rotor in the injection device of FIG. 1. FIG. 2 shows an embodiment of the injection device of FIG. FIG. 2 shows an embodiment of the injection device of FIG. FIG. 22 is a cross-sectional view of the injection device of FIG. 1 and the interaction of the rotor of FIGS. 21A and 21B with the needle cover clip of FIGS. 20A and 20B. FIG. 22 is a cross-sectional view of the injection device of FIG. 1 and the interaction of the rotor of FIGS. 21A and 21B with the needle cover clip of FIGS. 20A and 20B.

  Reference will now be made in detail to embodiments of the invention. Examples of these embodiments are illustrated in the accompanying drawings and refer to the same elements with the same reference numerals throughout the drawings. In the described embodiments, the invention is illustrated by reference to the drawings.

  Embodiments of the invention described below provide convenient patch-like infusion or self-delivery to deliver a pre-measured dose of a substance, such as a liquid drug or drug, to a patient over a period of time or all at once. It can be used as an injection device 100. The device is preferably provided to the end user in a pre-filled state, i.e. with the drug or medicament already in the reservoir of the device. The patch-like infusion or self-injection device 100 described herein (eg, as shown in FIG. 1) can be used by a patient and / or caregiver, but for convenience, the device user is referred to herein below. Is called “patient”. For further convenience, terms such as “vertical” and “horizontal” and “top” and “bottom” are used to denote the relative orientation relative to the infusion device 100 disposed on the horizontal surface. However, it will be appreciated that the injection device 100 is not limited to such an orientation, and the injection device 100 can be used in any orientation. Furthermore, the terms “infusion device” and “self-injection device” are used to describe a device embodying the present invention, but are not meant to be limiting. Infusion devices without a self-injection function are also within the scope of the invention, as are self-injection devices that do not perform continuous infusion. For convenience, but not for purposes of limitation, the term “infusion device” is used in the following description.

  The patch-like infusion device 100 of FIG. 1 is standalone and is attached to the patient's skin surface by an adhesive disposed on the bottom surface of the infusion device 100 (described in more detail below). After proper positioning and activation by the patient, one or more patient needles (e.g., microneedles) via the needle manifold using the pressure that the spring is released to apply to the flexible reservoir in the device The contents of the reservoir can be emptied through. The substance in the reservoir is then delivered through the patient's skin by microneedles that are driven into the skin. It will be appreciated that other embodiments are possible where the spring is replaced with a different type of stored energy device that can have mechanical, electrical, and / or chemical properties.

  As will be appreciated by those skilled in the art, there are many ways to construct and use the patch-like infusion device 100 disclosed herein. Reference is made to the embodiments illustrated in the drawings and the following description, however, the embodiments disclosed herein are not meant to be exclusive of the various alternative designs and embodiments encompassed by the disclosed invention. . In each of the disclosed embodiments, the device is referred to as an infusion device, but the device can also inject material at a much faster (bolus) rate than is typically achieved by a typical infusion device. For example, the contents can be delivered within a short period of a few seconds, or within a long period of a few days.

  In one embodiment of the device shown in FIGS. 1-12, the pushbutton design of the patch-like infusion device 100 is shown, and the activation and activation of the device is realized in a single multi-function / multi-step process. FIG. 1 shows an assembled embodiment of an injection device 100 in a pre-activated state. 2-6 show a partially exploded view and a cross-sectional view of the injection device 100 in a pre-activated state, FIG. 7 shows a partial exploded view of the injection device 100 during installation of the safety mechanism, and FIG. FIG. 10 shows an exploded view and a cross-sectional view of the injection device 100 after activation, and FIGS. 11 and 12 show an exploded view and a cross-sectional view of the injection device 100 after placement of the safety mechanism. The infusion device 100 can be pre-activated (eg, as shown in FIGS. 1, 2, and 5), activated or activated (eg, as shown in FIGS. 8-10), retracted, That is, it is configured to operate between safe states (eg, as shown in FIGS. 11 and 12).

  As shown in FIG. 1, one embodiment of a patch-like infusion device 100 includes a lower container 104, a safety mechanism 108, a flexible needle cover portion 112 of a needle cover 114, an upper container 116, a reservoir sub The assembly 120 includes an end-of-dose indicator (EDI) 124 and an activation device button 128 that includes a patient interface surface 132. In addition, as shown in FIGS. 2-6, the injection device 100 also includes a rotor or activation ring 136, a pressure spring 140, a dome-shaped metal plunger 144, and a drive spring 148.

  The flexible needle cover portion 112 provides patient and device safety by protecting at least one needle 152 (described in more detail below) and providing a sterile barrier. Needle cover portion 112 protects needle 152 during device manufacture, protects the patient prior to use, and provides a sterility barrier at any point prior to removal. According to one embodiment, the needle cover portion 112 is attached by a press fit with the needle manifold 154, in which at least one needle 152 is disposed. Further, according to one embodiment, the needle opening 156 (described in more detail below) of the safety mechanism 108 is shaped to closely correspond to the periphery of the needle cover portion 112.

  For example, as shown in FIGS. 2, 3, 5, 6, 8, 10, and 12, the reservoir subassembly 120 includes a reservoir 160, a reservoir dome seal 164, and a valve 168. Needle 152 and at least one channel 172 (see, eg, FIG. 8) disposed between valve 168 and needle 152 to provide a flow path therebetween. The reservoir 160 includes a dome 176. Further, the reservoir subassembly 120 includes a removable needle cover portion 112 to selectively cover at least one needle 152. According to one embodiment, the reservoir subassembly 120 also includes a reservoir arm seal 180 that covers the channel 172. The needle 152 preferably includes a needle manifold 154 and a plurality of microneedles 152.

  For example, as shown in FIG. 5, the reservoir dome seal (flexible membrane) 164 of the reservoir subassembly 120 is disposed between the plunger 144 and the dome 176. The contents of the reservoir (eg, pharmaceutical material) for the infusion device 100 are placed in the space between the reservoir dome seal 164 and the dome 176. The combination of reservoir dome seal 164, dome 176, and the space therebetween defines reservoir 160. The dome 176 is preferably transparent so that the contents of the reservoir can be observed. The reservoir dome seal 164 can be made from a non-intumescent material or laminate, such as a metal coated membrane or other similar substance. For example, one possible flexible laminate film that can be used in the reservoir dome seal 164 can provide an attachment mechanism for the first polyethylene layer and a third metal layer selected based on barrier properties. It includes a second chemical layer known to those skilled in the art and a fourth layer comprising polyester and / or nylon. By utilizing a metal-coated or metallized membrane together with a rigid portion (eg, dome 176), the barrier properties of reservoir 160 are improved, thereby improving the content of the contents contained within reservoir 160. Increase or improve shelf life. For example, if the contents of the reservoir contain insulin, the main contact materials in the reservoir 160 are linear low density polyethylene (LLDPE), low density polyethylene (LDPE), cyclic olefin copolymer (COC), and Teflon (registered) Trademark). As described in more detail below, the main contact materials in the remaining flow paths of the reservoir contents are also COC and LLDPE, and thermoplastic elastomers (TPE), medical grade acrylic, stainless steel, and needle adhesives (For example, an ultraviolet curable adhesive). Such materials that contact the contents of the reservoir 160 for extended periods of time preferably pass ISO 10-993 and other applicable biocompatibility tests.

  More preferably, the reservoir subassembly 120 can be stored in the relevant controlled environment without adversely affecting the contents for a predetermined shelf life of the reservoir contents and can be applied in various environmental conditions. Further, the barrier provided by the components of the reservoir subassembly 120 cannot transport gas, liquid, and / or solid material to and from the contents at a rate faster than is acceptable to meet the desired shelf life. Like that. In the embodiments shown above, the reservoir material can be stored and operated within a temperature range of about 34 to 120 degrees Fahrenheit (about 1 to 50 degrees Celsius) and has a shelf life of 2 years or more. be able to.

  In addition to meeting stability requirements, the reservoir subassembly 120 further ensures operation by passing any number of leak tests, such as holding a 30 psi (206900 Pa) sample without leakage for 20 minutes. Can do. Additional filling, storage, and delivery benefits resulting from the reservoir configuration include minimal head space and flexibility, as described in more detail below.

  In one embodiment, reservoir 160 is evacuated prior to filling. By evacuating the reservoir 160 prior to filling and minimizing the vacuum in the dome 176, the headspace and excess waste in the reservoir 160 can be minimized. Further, the reservoir shape can be configured to match the type of biasing mechanism (eg, pressure spring 140 and plunger 144) used. Further, the evacuated flexible reservoir 160 is used during filling to minimize any air or bubbles in the filled reservoir 160. It is also very beneficial to use a flexible reservoir 160 when the infusion device 100 is subject to external pressure or temperature fluctuations that can lead to an increase in the internal pressure of the reservoir. In such a case, the flexible reservoir 160 expands and contracts with the contents of the reservoir, thereby preventing possible leaks due to expansion and contraction forces.

  Yet another feature of reservoir 160 includes the ability to allow automated particle inspection when filled or when used by a patient. One or more reservoir barriers, such as the dome 176, can be molded from a transparent transparent plastic material so that the substance contained in the reservoir can be inspected. The permeable transparent plastic material is preferably a cyclic olefin copolymer characterized by high permeability and transparency, low extractability, and biocompatibility with the substance contained in the reservoir 160. Suitable materials are those from Zeon Chemicals, L., Louisville, Kentucky. P. Available under the name “BD CCP Resin” and is described by the US Food and Drug Administration and DMF 16368. In such applications, the reservoir 160 contains minimal features that can interfere with inspection (ie, allows rotation during inspection).

  A channel arm 172 is provided in the form of at least one flexible arcuate arm that extends from valve 168 to needle manifold 154 or microneedle 152. A groove 174 (see, for example, FIG. 2) is formed in the arc-shaped arm. Reservoir arm seal 180 covers groove 174 to provide a fluid pathway between valve 168 and needle manifold 154 or microneedle 152. The fluid path between reservoir 160 and microneedle 152 (eg, disposed within channel arm 172 as shown in FIG. 8) is constructed from a material similar or identical to the materials described above with respect to reservoir 160. For example, channel arm 172 can be constructed from the same material as dome 160 and reservoir arm seal 180 can be constructed from the same material as reservoir dome seal 164. According to one embodiment, both channel arms 172 are used as a fluid path between valve 168 and needle manifold 154 or microneedle 152. According to another embodiment, only one channel arm 172 is used as a fluid path and the remaining channel arms 172 provide structural support. In such an embodiment, groove 174 extends completely from valve 168 to needle manifold 154 or microneedle 152 only in channel arm 172 used as a fluid path.

  The channel arm 172 must be flexible enough to withstand the actuation force. Unlike the position of the channel arm 172 in FIGS. 2 and 8, when the microneedle 152 is driven into the patient's skin, the channel arm 172 (covered by the reservoir arm seal 180 in FIG. It is elastically deformed (which will be explained in more detail below). During such deformation, the channel arm 172 must maintain fluid path integrity between the valve 168 and the needle manifold 154 or microneedle 152. Furthermore, the material for the channel arm 172 satisfies a number of biocompatibility and storage tests. For example, as shown in Table 1 below, if the contents of the infusion device include insulin, the main contact material in reservoir 160 is linear low density polyethylene, cyclic olefin copolymer, and Teflon. And transparent transparent plastics. The main contact material in the remaining flow path (channel 62) between the reservoir 160 and the microneedles 152 of the needle manifold 154 is COC and / or medical grade acrylic, LLDPE, TPE, and stainless steel, and needle adhesion Contains agents.

  More particularly, the microneedle 152 can be constructed from stainless steel and the needle manifold 154 can be constructed from polyethylene and / or medical grade acrylic. Such materials preferably pass the ISO 10-993 biocompatibility test when in contact with the contents of the reservoir for extended periods of time.

  A valve 168 disposed between the reservoir 160 and the channel 172 selectively allows and restricts fluid flow between the reservoir 160 and the channel 172. Valve 168 moves between a pre-activated position (eg, as shown in FIGS. 2, 3, and 6) and an activated position (eg, as shown in FIGS. 8-10). When in the activated position, the valve allows fluid flow between reservoir 160 and channel 172, and thus to needle manifold 154 and microneedle 152.

  In use, the valve 168 is ultimately pushed into the activated position by movement of the activator button 128, as best shown by movement of the valve 168 between FIGS. As shown in FIG. 10, the movement of valve 168 advances the enlarged distal end of valve 168 so that drug flows from reservoir 160 into channel 172 and through the fluid path to needle manifold 154. Can flow.

  Although the embodiments described above include at least one needle 152 or microneedle 152, a plurality of illustrated microneedles 152, such as two, can be accommodated. Each microneedle 152 is preferably at least 31 gauge or less, such as 34 gauge, and is secured within a needle manifold 154 that can be placed in fluid communication with the reservoir 160. The microneedles 152 can be of different lengths or gauges when two or more are included in the infusion device 100, or both can be of different lengths and gauge combinations, and the length of the body. One or a plurality of ports can be accommodated, and if any of the microneedles 152 has a single port, the ports should be located near the tip of the microneedle 152 or near the slope of the tip Is preferred.

  According to one embodiment, the gauge of the microneedle 152 determines the delivery rate of the reservoir contents of the infusion device 100. It is practical to use a plurality of 34 gauge microneedles 152 to deliver reservoir contents when infusion occurs over a period longer than that associated with immediate syringe injection, which generally requires a much larger cannula or needle. is there. In the disclosed embodiments, any microneedles 152 that target the intradermal or subcutaneous space can be used, but the illustrated embodiment provides an intradermal micro that is 1 to 7 mm (ie, 4 mm) in length. A needle 152 is included. The configuration of the microneedles 152 can be a linear or non-linear array and can include any number of microneedles 152 required for a particular application.

  As described above, the microneedle 152 is positioned within the needle manifold 154. Within the needle manifold 154, each microneedle 152 is provided with at least one fluid communication path or channel 172. The manifold may simply have a single path to one or more microneedles 152, or may provide multiple fluid paths or channels that route the reservoir contents to each microneedle 152 separately. it can. These paths or channels can further include a tortuous path for the contents to travel, thereby affecting fluid pressure and delivery rate and acting as a flow restrictor. The channel or path within the needle manifold 154 can be a range of widths, depths, and configurations depending on the field of application, with the channel width typically ranging from about 0.015 inch (0.381 mm) to 0.04 inch. (1.016 mm), preferably 0.02 inch (0.508 mm), and is constructed to minimize dead space in the manifold.

  According to one embodiment, reservoir subassembly 120 has a pair of holes 184 and 188 to aid in alignment of reservoir subassembly 120 with respect to lower container 104. Inserted into the respective holes 184 and 188 are a first post 192 and a second post 196 (described in more detail below) of the lower container 104.

  4, 7, and 9 are exploded views with the reservoir subassembly 120 removed, wherein the lower container 104 includes a substantially cylindrical housing 200, and a pressure spring 140 and plunger 144 within the housing 200. Is placed. According to one embodiment, the cylindrical housing 200 includes a plurality of concave channels 204 for guiding a respective plurality of legs 208 and legs 212 of the plunger 144 as the plunger translates within the housing 200. . Collectively, the leg 208 and the foot 212 constitute a plunger tab 214. For example, as shown in FIGS. 4, 7, and 9, the concave channel 204 extends from the upper part of the cylindrical housing 200 only to a portion that goes down the cylindrical housing 200. Located below the recessed channel 204 is an opening 216 through which the foot 212 of the plunger 144 can extend out of the cylindrical housing 200. Opening 216 is substantially L-shaped and has a horizontal portion located at the base of cylindrical housing 200 and a vertical portion substantially aligned with concave channel 204.

  When the injection device 100 is in a pre-activated state, the pressure spring 140 is compressed by the plunger 144 (eg, as shown in FIGS. 4-6), and the foot 212 of the plunger 144 is horizontal to the opening 216. Substantially disposed within the portion. The force of the pressure spring 140 biases the foot 212 of the plunger 144 toward the top of the horizontal portion of the opening 216 (ie, the bulge of the cylindrical housing 200). Together, as will be described in greater detail below, the pressure spring 140 and plunger 144 form a pressure system for pressurizing the reservoir 160 when the infusion device 100 is activated.

  As described in more detail below, a pre-activated position (eg, as shown in FIGS. 2-4) and an activated position (eg, FIGS. 8-8) around the base of the cylindrical housing 200 10), the rotor 136 rotates. When the rotor 136 rotates from the pre-activated position to the activated position, at least one foot engaging surface 220 (eg, shown in FIG. 4) of the rotor 136 causes at least one of the legs 212 of the plunger 144 to move. And the plunger 144 is rotated so that the foot 212 is aligned with the vertical portion of the opening 216 and the recessed channel 204. At this point, the pressure spring 140 moves the plunger 144 upward and the foot 212 is guided by the raised channel 204.

  A pressure spring 140 is included in the infusion device 100 to exert an essentially uniform force on the reservoir 160 to push the contents out of the reservoir 160. The pressure spring 140 is used to store energy that pressurizes the reservoir 160 when released in use. The pressure spring 140 is held in a compressed state by the engagement between the leg 212 of the plunger 144 and the cylindrical housing 200. This engagement prevents pressure spring 140 from stressing the membrane of reservoir 160 (described below) or any remaining device components (other than lower container 104 and plunger 144) during storage. Plunger 144 is sufficiently rigid to withstand the tension and deformation of the spring and should not be disturbed by service loads.

  As described above, when the rotor 136 rotates from the pre-activated position to the activated position, the rotor 136 engages at least one of the legs 212 of the plunger 144 and causes the legs 212 to engage the openings 216. The plunger 144 is rotated to align with the vertical portion and the concave channel 204. The compressed pressure spring 140 then moves the plunger 144 upward, thereby exerting a force on the membrane of the reservoir 160. The pressure spring 140 preferably applies a pressure of about 1 psi (6895 Pa) to 50 psi (344800 Pa) within the reservoir 116, more preferably about 2 psi (13790 Pa) to about 25 psi (172400 Pa) for intradermal delivery of the reservoir contents. It can be configured to occur. For subcutaneous injection or infusion, a range of about 2 psi (13790 Pa) to 5 psi (34480 Pa) will be sufficient.

  According to one embodiment, the activator button 128 includes a patient interface surface 132 that the patient presses to activate the infusion device 100. Activator button 128 also includes a hinge arm 224 and an activation arm 228 (eg, both shown in FIG. 3). The hinge arm 224 of the activator button 128 includes a cylindrical portion having an opening. The activation arm 228 includes a tab 230 (see, eg, FIG. 3). According to one embodiment, the tab 230 includes a bearing surface 232 and a locking surface 234 disposed adjacent to the cantilevered end of the bearing surface 232. According to one embodiment, the tab 230 forms an acute angle with respect to the main portion of the activation arm 228.

  A first post 192 disposed in the lower container 104 extends upward from the lower container 104. According to one embodiment (eg, as shown in FIGS. 4 and 7), the base of the first post 192 includes a pair of flat side surfaces 236 and a pair of rounded side surfaces 240. Further, for example, as shown in FIGS. 4 and 7, the second post 196 and the first drive spring base 244 and the second drive spring base 248 extend upward from the lower container 104. As will be described in more detail below, the first drive spring base 244 and the second drive spring base 248 secure the respective ends of the drive spring 148. The first drive spring base 244 is disposed adjacent to the second post 196, and a space is provided between the first drive spring base 244 and the second post 196.

  According to one embodiment, FIGS. 3 and 6 illustrate positioning the activator button 128 relative to the lower container 104 for assembly of the activator button 128. In this position, the opening of the cylindrical portion of the hinge arm 224 allows the activator button 128 to slide horizontally (through the flat side 236) and engage the first post 192. The hinge arm 224 (and thus the activator button 128) can then rotate around the first post 192. As the activation arm 228 enters the space between the second post 196 and the first drive spring base 244, the cantilevered end of the bearing surface 232 of the tab 230 passes through the retaining surface 252 of the second post 196. Until at least one of the tab 230 and the activation arm 228 is elastically deformed. The cantilevered end of the bearing surface 232 of the tab 230 exceeds the retaining surface 252 (see, eg, FIG. 4) of the second post 196 and the locking surface 234 of the tab 230 engages the retaining surface 252 so that an audible click And providing tactile feedback to signal that the activator button 128 has reached the pre-activated position.

  Referring again to FIGS. 2 to 4 and 7 to 9, the rotor 136 further includes an activation protrusion 256 and a drive spring holder 260. The activation arm 228 of the activation device button 128 engages the activation projection 256 when the patient depresses the activation device button 128, thereby rotating the rotor 136 from the previously activated position to the activated position.

  The drive spring holder 260 maintains the drive spring 148 in the pre-activated position when the rotor 136 is in the pre-activated position. As described above, the first drive spring base 244 and the second drive spring base 248 fix the both ends of the drive spring 148. A substantially U-shaped protrusion for engaging with the drive spring holder 260 of the rotor 136 is located approximately at the midpoint of the drive spring 148, for example, as shown in FIGS. Thus, when the rotor 136 reaches the pre-activated position and the drive spring 148 engages the drive spring holder 260, the drive spring 148 is maintained in tension. When drive spring holder 260 releases drive spring 148 (i.e., when the rotor rotates from a previously activated position to an activated position, e.g., as shown in Figs. 8-10), drive spring 148 becomes microscopic. The needle 152 is driven to extend outside the injection device 100 through the opening 300 in the lower container 104 (and also through the opening in the safety mechanism 108, as will be described in more detail below).

  Thus, as will be described in more detail below, activation and activation of the infusion device 100 implemented in a single multifunction / multi-step process can be achieved by the patient depressing the activation button 128 and the activation button 128. Rotating the rotor 136 for engagement between the activation arm 228 and the activation protrusion 256 of the rotor 136. As described above, the rotation of the rotor 136 rotates and releases the plunger 144 to pressurize the fluid in the reservoir 160. Furthermore, rotation of the rotor 136 releases the drive spring 148 from the drive spring holder 260, thereby driving the microneedle 152 to extend outside the injection device 100. A single multi-function / multi-step process also activates valve 168 from a pre-actuated position so that when activator button 128 is depressed, activator button 128 engages valve 168 and moves valve 168. Moving to a designated position, thereby starting to flow fluid between the reservoir and microneedle 152 via channel 172.

  As described above, the patch-like infusion device 100 also includes a safety mechanism 108. A lock needle safety mechanism 108 is provided to prevent inadvertent or accidental needle stick injury, prevent intentional reuse of the device, and shield exposed needles. The safety mechanism 108 is automatically activated as soon as the infusion device 100 is removed from the patient's skin surface. According to one embodiment described in more detail below, a flexible adhesive pad 264 adheres to the lower portion of the lower container 104 and the lower portion of the safety mechanism 108. The adhesive pad 264 contacts the patient's skin and holds the infusion device 100 in place on the skin surface during use. For example, as shown in FIGS. 11 and 12, when removing the infusion device 100 from the skin surface, the safety mechanism 108 extends to a position that shields the microneedles 152. When fully extended, the safety mechanism 108 is locked in place to prevent accidental injury or exposure to the patient needle 152.

  In general, passive safety systems are most desirable. This allows the device to self-protect if it is accidentally removed or if the patient forgets that there is a safety step. One typical application for this infusion device 100 is to provide human growth hormone, which is usually given at night, so the device can be used even if it is thought that it will take less than 10 minutes to deliver. A wearing patient (such as a child) can actually be considered wearing the device overnight. Without a passive system, the microneedle 152 may pierce the patient or caregiver if the injection device 100 is removed. The solution is to limit operations in use or include a passive safety system.

  There are usually three options for safety systems. The first option is to retract the needle 152 into the device. The second option is to shield the needle 152 and remove access, and the third option is to break the needle 152 to prevent injury to the needle. Other systems, such as active systems, further utilize manual shielding and / or destruction of safety features or manual release by pressing a button or similar operation. A detailed description of the passive safety embodiment of the present invention is provided below.

  One safety embodiment of the present invention is an embodiment of a passive fully sealed extraction design, such as a safety mechanism 108. 5, 10 and 12 are perspective cutaway views of the infusion device 100 showing the safety mechanism 108 before, after and after activation of the safety mechanism 108, respectively.

  When the infusion device 100 is removed from the skin, the flexible adhesive pad 264 (attached to both the bottom surface of the lower container 104 and the bottom surface of the safety mechanism 108) pulls the safety mechanism 108 and locks into place. From the skin surface. In other words, the force required to remove the adhesive pad from the skin surface is greater than the force required to deploy the safety mechanism 108. According to one embodiment, for example, as shown in FIG. 13, the safety mechanism 108 includes a flat surface portion 268 that contacts the patient's skin. The flat surface 268 is the portion where a portion of the adhesive pad 264 (shown as a dotted line in FIG. 13) is attached to the safety mechanism 108 and the adhesive pad 264 is removed from the skin by the patient when the infusion device 100 is removed from the skin. From the patient, thereby shielding the microneedles 152 that would otherwise be exposed when the infusion device 100 is removed from the patient. When the safety mechanism 108 is fully extended, the safety mechanism 108 is locked in place to prevent accidental injury or exposure to the microneedle 152.

  According to one embodiment, the adhesive pads 264 are provided in substantially two parts, one located in the bulk of the bottom surface of the lower container 104 and the other located on the bottom surface of the safety mechanism 108. When the injection device 100 is removed, the two patches move independently and the safety mechanism 108 can rotate relative to the lower container 104. According to another embodiment, the two parts are formed as an integral flexible adhesive pad 264, one part is placed in the bulk of the bottom surface of the lower container 104 and the other part is the bottom surface of the safety mechanism 108. Placed in.

  According to one embodiment, the safety mechanism 108 is a stamped metal part. According to another embodiment, the safety mechanism 108 is made from substantially the same material as the lower container 104. As shown in FIG. 14, the safety mechanism 108 includes a front shield 272, a pair of insertion tabs 276 disposed in the rear portion of the safety mechanism 108, and an upper rear end portion of the outer peripheral portion 284 of the safety mechanism 108, respectively. It includes a pair of pivot tabs 280 disposed, a guide post 288 extending upwardly from the substantially flat lower inner surface of the safety mechanism 108 and a lock post 292 also extending upwardly from the lower inner surface of the safety mechanism 108. The front shield 272 extends above the outer peripheral portion 284 and shields the patient from the microneedle 152 when the safety mechanism 108 is deployed. The guide post 288 includes a cutout therein that engages a safety retaining protrusion 296 (eg, as shown in FIGS. 7 and 9) of the rotor 136 when the rotor 136 is in a pre-activated position, so that the injection device 100 The safety mechanism 108 is prevented from being placed before the activation.

  Further, as described above, the safety mechanism 108 includes a needle opening 156. Prior to deployment of the safety mechanism 108, the needle opening 156 at least partially overlaps the opening 300 in the lower container 104 to provide a space for moving the microneedle 152. The lock posts 292 are each disposed adjacent to the front edge of the needle opening 156. The lower container 104 includes a guide post opening 304 (eg, as shown in FIGS. 7 and 9) and a pair of insertion tab openings 308 (eg, as shown in FIG. 4) positioned adjacent the opposite edges of the lower container 104. One) and a pair of pivot stops 312 (eg, shown in FIGS. 7 and 9) disposed on opposite sides of the lower container 104.

  Referring again to FIG. 14, the insertion tabs 276 each include a connection portion 316 and an extension portion 320. According to one embodiment, the connecting portion 316 extends from the lower inner surface of the safety mechanism 108 toward the rear of the injection device 100 at an angle that is not perpendicular to the lower inner surface of the safety mechanism 108. Each extension portion 320 extends from the extension portion 320 to a respective outer side of the safety mechanism 108 at a substantially right angle. To combine the safety mechanism 108 with the lower container 104, the safety mechanism 108 is held at an angle of about 45 ° relative to the lower container 104 and the insertion tab 276 is inserted into the insertion tab opening 308. The safety mechanism 108 is then rotated to a position such that the guide post 288 is inserted into the guide post opening 304 and the lower inner surface of the safety mechanism 108 contacts the bottom surface of the lower container 104 substantially parallel.

  Referring again to FIGS. 7 and 9, these figures show the rotor 136 in the activated position, but the disassembled nature of FIGS. 7 and 9 is the stage at which the safety mechanism 108 is combined with the lower container 104. It is convenient to show. However, it will be appreciated that the safety mechanism 108 must be assembled to the lower container prior to activation. As shown in FIG. 4, after rotating the safety mechanism 108 upward, the safety mechanism 108 translates backward relative to the lower container 104, and thus the pivot tab 280 is moved to the respective leading edge of the pivot stop 312. The lock post 292 is disposed adjacent to the side edge of the opening 300 of the lower container 104, and the safety retaining protrusion 296 of the rotor 136 is disposed on the guide post 288. Engage.

  Returning to FIG. 14, each lock post 292 includes a post extension 324 that extends substantially perpendicularly from the flat lower inner surface of the safety mechanism 108 and a wedge portion 328 disposed at the end of the post extension 324. As the height of the wedge portion 328 relative to the lower inner surface of the safety mechanism 108 increases, the width of the wedge portion 328 also increases.

  When the safety mechanism 108 is positioned and rotated downward relative to the lower container 104, the wedge portions 328 act against the respective side edges of the opening 180 of the lower container 104 and elastically deform the lock posts 192 toward each other. Let When the safety mechanism 108 is fully deployed, the tab 280 is located within the pivot stop 312. In addition, the upper edge of the wedge portion 328 passes through the lower edge of the opening 300 and the lock post 292 returns to a substantially undeformed state, providing audible clicks and tactile feedback, and the safety mechanism 108 is fully positioned. Therefore, it informs that the microneedle 152 is covered. Returning to FIGS. 11 and 12, after the safety mechanism 108 is fully positioned and the lock post 292 has returned to a substantially undeformed state, the upper edge of the wedge portion 328 is the lower container adjacent to the opening 300. Engage with the bottom surface of 104, thereby preventing the safety mechanism 108 from rotating upward relative to the lower container 104 to expose the microneedles 152. Further, as described above, the front shield 272 shields the patient from the microneedle 152.

  Thus, the safety mechanism 108 is a passive safety embodiment that is provided as a single part and provides a good lock that does not break under human load. With this passive safety mechanism, no additional force is applied to the skin during injection and the microneedle 152 is safely held in the injection device 100 after use.

  After using the infusion device 100, the patient can examine the device once more to confirm that the full dose has been delivered. For this purpose, as shown in FIGS. 15A-15D, the infusion device 100 includes an end of dose indicator (EDI) 124. The EDI 124 includes a main body 332 and a first arm 336 and a second arm 340 that extend substantially horizontally with respect to the top of the main body 332.

  The EDI 124 also includes a spring arm 344 that curves upward from the top of the body 332. According to one embodiment, the spring arm 344 pushes the lower side of the reservoir subassembly 120 to elastically bias the EDI 124 toward the lower container 104 so that, for example, during shipping and handling of the infusion device 100, the EDI 124 So that you don't get out of it.

  Returning to FIG. 4, the body 332 is disposed within the EDI channel 348 and translates substantially vertically within the EDI channel 348. The EDI channel is adjacent to one of the recessed channels 204 that guide the legs 208 and legs 212 of the plunger 144. The first arm 336 extends across the entire top of this concave channel 204.

  Returning to FIG. 15A, a vertical extrusion 352 extends upward from the end of the second arm 340. When the reservoir contents are delivered, the vertical extrusion extends through the EDI opening 356 (see, eg, FIG. 15C) in the upper container 116 to signal that the end of administration has been reached. According to one embodiment, EDI 124 is formed as a unitary structure.

  As shown in FIG. 15B, one of the legs 212 of the plunger 144 contacts the first arm of the EDI 124 as the plunger 144 is advanced upward within the cylindrical housing 200 for the pressure spring 140 after activation. The foot 212 lifts the EDI 124 upward to overcome the bias of the spring arm 344 and the vertical pusher 352 extends increasingly through the EDI opening 356 during delivery of the reservoir contents. Referring again to FIG. 10, the vertical extrusion 352 extends partially from the injection device 100. After delivery of the reservoir contents is complete and the plunger has achieved the full stroke, the vertical extrusion 352 is fully extended, as shown in FIG. 15D. Thus, the EDI 124 uses the linear movement of the plunger 144 to generate a linear movement of the EDI 124 that can be seen outside the infusion device 100, thereby conveying delivery of the reservoir contents.

  FIG. 16 illustrates one embodiment of an injection device 400 having an injection port 404. The injection port provides access to an exhaust or partially filled reservoir 408 so that the patient can inject a substance or combination of substances into the reservoir prior to activation. Alternatively, a pharmacist or pharmacist can use injection port 404 to fill infusion device 400 with a substance or combination of substances prior to sale. In substantially all other respects, the injection device 400 is similar to the injection device 100 described above.

  The operation of the injection device 100 will now be described. The above-described embodiments of the present invention preferably include a push button (activator button 128) design, where the infusion device 100 is positioned and attached to the skin surface and biased and / or activated by pressing the activator button 128. Can be made. More particularly, in a first step, the patient removes the device from a sterile package (not shown) and removes the release liner (discussed in more detail below) of the adhesive pad 264. The patient also removes the needle cover 114 (also discussed in more detail below). When the infusion device 100 is removed from the package, the patient is in a pre-activated state prior to use (see, eg, FIGS. 1, 2, 4, and 5) so that the patient Both the device and the contents within the device can be inspected, including inspection of missing or damaged, expiration date (s), drug turbidity or color change.

  The next step is to position and apply the infusion device 100 to the patient's skin surface. Like a pharmaceutical patch, the patient presses the injection device 100 firmly against the skin. One side of the adhesive pad 264 adheres to the bottom surface of the lower container 104 and the bottom surface of the safety mechanism 108, and the opposite side of the adhesive pad 264 secures the infusion device 100 to the patient's skin. In an alternative embodiment, the adhesive pad 264 can be replaced with an adhesive applied directly to the bottom surface of the lower container 104 and the bottom surface of the safety mechanism 108. Such adhesive should be covered by a release liner prior to use of the injection device 100. These bottom surfaces (the bottom surface of the lower container 104 and the safety mechanism 108) can be flat, undulated, or formed into any suitable shape, and the adhesive pad 264 is secured over these bottom surfaces. Is done. As discussed in more detail below, according to one embodiment, prior to shipping, a release liner, such as a membrane, is attached to the patient side of the adhesive pad 264 to protect the adhesive during shipping. As described above, prior to use, the patient removes the release liner, thereby exposing the adhesive pad 264 (or adhesive) and placing it on the skin.

  After removing the release liner, the patient can place the infusion device 100 on the skin and press down to confirm proper adhesion. After being properly positioned as described above, the device is activated by depressing the activation device button 128. This activation step releases the plunger 144 and the pressure spring 140, which allows the plunger 144 to press the flexible membrane of the reservoir 160 (reservoir dome seal 164), thereby pressurizing the reservoir. This activation step also serves to release the drive spring 148 from the drive spring holder 260 of the rotor 136, thereby driving the microneedle 152 to extend outside the infusion device 100 (opening 300 and safety in the lower container 104). Microneedle 152 is placed in the patient (through needle opening 156 of mechanism 108). In addition, the activation step opens valve 168 and establishes a fluid communication path between reservoir 160 and microneedle 152 via channel 172 (see, eg, FIGS. 8-10). Each of these operations can be realized with a single push button action, resulting in significant benefits. Furthermore, another significant benefit includes the use of a continuous fluid communication path that is fully configured within the reservoir subassembly 120.

  After activation, the patient typically leaves the infusion device 100 in place or wears the device for a period of time (such as 10 minutes to 72 hours) until the reservoir contents are completely delivered. The patient then removes and discards the device without damaging the underlying skin or tissue. When intentionally or accidentally removed, one or more safety features are placed to shield the exposed microneedles 152. More particularly, when the infusion device 100 is removed from the skin by the patient, the adhesive pad 264 acts to position the safety mechanism 108 from the infusion device 100, thereby normally if the infusion device 100 is removed from the patient. The microneedles 152 that should be exposed are shielded. When the safety mechanism 108 is fully extended, the safety mechanism 108 is locked in place to prevent accidental injury or exposure to the microneedle 152. However, the safety feature can be configured not to be placed if the activator button 128 is not pressed and the microneedle 152 is not extended, thereby preventing placement of the safety mechanism prior to use. . After use, the patient can examine the device again to confirm that the full dose has been delivered. For example, the patient can observe the interior of the reservoir through the permeable dome 176 and / or examine the EDI 124.

  The described embodiments are suitable for use in administering various substances, including drugs and pharmaceuticals, to patients, particularly human patients. As used herein, a pharmaceutical includes a biologically active substance that can be delivered through the body membrane and body surface, particularly the skin. Examples include antibiotics, antiviral agents, analgesics, anesthetics, appetite suppressants, anti-arthritic agents, antidepressants, antihistamines, anti-inflammatory agents, anti-neoplastic agents, DNA vaccines, as described in more detail below. Includes vaccines. Other substances that can be delivered to the patient intradermally or subcutaneously include human growth hormone, insulin, proteins, peptides, and fragments thereof. Proteins and peptides can be naturally occurring, synthetic, or recombinantly produced. Furthermore, the device can be used in cell therapy, such as during intradermal injection of dendritic cells. Still other substances that can be delivered by the method of the present invention, such as described in US Pat. No. 5,637,097, entitled “Method of Intradermally Injecting Substances”, the entire contents of which are expressly incorporated herein by reference, are diseases. Can be selected from the group consisting of drugs, vaccines, etc. used in the prevention, diagnosis, mitigation, treatment, or recovery of: α1-antitrypsin, anti-angiogenic agents, antisense, butorphanol, calcitonin and Analogs, ceredes, COX-II blockers, hull agents, dihydroergotamine, dopamine agonists and antagonists, enkephalins and other opioid peptides, epidermal growth factor, erythropoietin and analogs, follicle stimulating hormone, G-CSF, glucagon, GM- CSF, granisetron, growth hormone and the like Analogs (including growth hormone releasing hormone), growth hormone antagonists, hirudin analogs such as hirudin and hirulog, IgE antibodies, insulin, insulinotropin and the like, insulin-like growth factor, interferon, interleukin, luteinizing hormone, Luteinizing hormone-releasing hormone and analogs, low molecular weight heparin, M-CSF, metoclopramide, midazolam, monoclonal antibodies, narcotic analgesics, nicotine, non-steroidal anti-inflammatory drugs, oligosaccharides, ondansetron, parathyroid hormone and the like , Parathyroid hormone antagonist, prostaglandin antagonist, prostaglandin, recombinant soluble receptor, scopolamine, serotonin agonist and antagonist, sildenafil, ter Tallin, thrombolytic agents, tissue plasminogen activator, TNF and TNF antagonists, vaccines with or without carriers / adjuvants, addiction, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease, meningococcus, measles, mumps, rubella, chickenpox, yellow fever, respiratory syncytial virus, tick-borne Japanese encephalitis, pneumococci, streptococcus, typhoid, influenza, type A, Hepatitis including hepatitis B, C, and E, otitis media, rabies, polio, HIV, parainfluenza, rotavirus, Epstein Barr virus, CMV, Chlamydia, unclassifiable hemophilus, Moraxella catarrhalis, human papilloma virus Tuberculosis including BCG, hemorrhoids, asthma, atherosclerotic malaria (atheros) thrombosis malaria), Escherichia coli, Alzheimer, Helicobacter pylori, Salmonella, diabetes, cancer, herpes simplex, human papillomas, etc., including but not limited to subunit proteins, peptides And polysaccharides, polysaccharide conjugates, toxoids, gene-based vaccines, live vaccines, reassortants, inactivated vaccines, whole cells, viruses and bacterial vectors), and other substances include cold remedies Anti-addiction agent, anti-allergic agent, antiemetic agent, anti-obesity agent, anti-osteoporosis agent, anti-infective agent, analgesic agent, anesthetic agent, appetite suppressant, anti-arthritis agent, anti-asthma agent, anti-convulsant agent, anti Depressant, anti-diabetic agent, antihistamine, anti-inflammatory agent, anti-migraine agent, anti-anxiety agent, anti-emetic, anti-malignant tumor Agents, antiparkinsonian drugs, antidiarrheals, antipsychotics, antipyretic drugs, antiacetylcholine drugs, benzodiazepine antagonists, vasodilators including systemic blood vessels, coronary blood vessels, peripheral blood vessels, and cerebral blood vessels, bone stimulators, central nervous stimulants, Hormones, hypnotics, immunosuppressants, muscle relaxants, parasympathetic blockers, parasympathomimetics, prostaglandins, proteins, peptides, polypeptides and other macromolecules, psychostimulants, sedatives, sexual dysfunction and All major therapeutic agents such as tranquilizers and major diagnostic agents such as tuberculin and other hypersensitivity drugs are included.

  Vaccine formulations that can be delivered by the systems and methods of the present invention, as described in US Pat. No. 5,077,028, entitled “Vaccine Delivery System”, the entire contents of which are expressly incorporated herein by reference, are directed against human pathogens. An antigen or antigen composition capable of eliciting an immune response can be selected from the group consisting of HIV-1 (such as tat, nef, gp120, or gp160), gD or Human herpesvirus (HSV) such as its derivatives or early proteins such as ICP27 from HSV1 or HSV2, cytomegalovirus (CMV (especially human) (such as gB or a derivative thereof), rotavirus (including attenuated virus), Epstein-Barr virus (gp350 or its induction Etc.), derived from varicella-zoster virus (such as VZV, gp1, II, and IE63), or hepatitis B virus (eg, hepatitis B surface antigen or derivative thereof), hepatitis A virus (HAV), type C Hepatitis virus, and other viral pathogens such as paramyxovirus, respiratory syncytial virus (such as RSV, F and G proteins or derivatives thereof), parainfluenza virus, measles A virus, mumps virus, human papilloma virus (HPV, eg HPV 6, 11, 16, 18), flavivirus (eg yellow fever virus, dengue virus, tick-borne encephalitis virus, Japanese encephalitis virus), or Influenza virus (whole or inactivated virus) Or whole influenza virosomes such as HA, NP, NA, or M proteins, or purified or recombinant proteins thereof, or combinations thereof), or gonococci and Neisseria meningitidis (eg, capsular polysaccharides and conjugates thereof, transferrin binding protein, lactoferrin binding protein, PilC, adhesin), Streptococcus pyogenes (eg, M protein or fragment thereof, C5A protease, lipoteichoic acid), group B Moraxella, including Streptococcus, Neisseria, including Streptococcus mutans, Soft gonococci, Cataract, also known as Blanchamella catarrhalis (eg, high and low molecular weight adhesins and invasins), Hundred Days Bordetella spp. (Eg, ESAT6, antigens 85A, B), including fungi (eg, pertactin, pertussis toxin, or derivatives thereof, filamentous hemagglutinin, adenylate cyclase, fimbria), parapertussis, and bronchial septic bacteria Or C), Mycobacterium genus including M. bovine, L. bacterium, M. avian, Yone, Smegma, L. Legionella genus including pneumofila, enterotoxic Escherichia coli (eg, colonization factor, heat-labile toxin or derivative thereof, heat-stable toxin or derivative thereof), enterohemorrhagic E. coli, enteropathogenic E. coli (eg, Shiga toxin-like toxin) Or a derivative thereof), Escherichia genus including Vibrio cholerae (for example, cholera toxin or derivatives thereof), Shigella Sonne, Shiga Shigella, Shigella including flexinel Shigella, Enterocolitica (eg, Yop) Protein), Yersinia, including Plasmodium pestis and pseudotuberculosis, Jejuni (eg, toxins, adhesins, and invasins) and C.I. Campylobacter genus including coli, Salmonella including Salmonella including Salmonella enterococcus, Listeria including Listeria, Helicobacter including Pseudomonas (eg, urease, catalase, vacuolating toxin), Pseudomonas aeruginosa Pseudomonas genus containing bacteria, Staphylococcus aureus, Staphylococcus genus including Staphylococcus epidermidis, Fecaris, E.E. Enterococcus containing fesium, tetanus (eg, tetanus toxin and derivatives thereof), botulinum (eg, botulinum toxin and derivatives thereof), C.I. Corynebacterium, including Clostridium spp., Including C. difficile (eg, Clostridial toxin A or B and derivatives thereof), Bacillus spp., Including Bacillus anthracis (eg, botulinum toxin, and derivatives thereof), Diphtheria (eg, diphtheria toxin, and derivatives thereof) Genus B. Burgdorferi (eg, OspA, OspC, DbpA, DbpB), B.I. Galini (eg, OspA, OspC, DbpA, DbpB), B.I. Afzeli (eg, OspA, OspC, DbpA, DbpB), B.I. Andersoni (eg, OspA, OspC, DbpA, DbpB), B.I. Borrelia spp. Erichia, including Equi and human granulocyte pathogens, Rickettsia, including spotted fever rickettsia, trachoma pathogens (eg, MOMP, heparin binding protein), Chlamydia pneumoniae pathogens (eg, MOMP, heparin binding protein), parrot pathogens Chlamydia, including L. Leptospira, including interrogans, syphilis treponema (eg, rare outer membrane proteins), T. Denticola, T. Derived from bacterial pathogens such as Treponema, including hyodysenteria, or Plasmodium, including Plasmodium falciparum, Toxoplasma, including Toxoplasma gondii (eg, SAG2, SAG3, Tg34), Endophytic Amoeba, including Shigella amoeba , B. Babesia spp. Trypanosoma genus including Cruz, Giardia genus including Rumble flagellate, Leishmania genus including large Leishmania, P. C. pneumoniae including C. pneumoniae, C. pneumoniae including vaginal trichomonas, C. pneumoniae including S. mansoni, and Candida spp. Derived from yeasts such as the genus Cryptococcus including neoformans.

  These also include other preferred specific antigens against Mycobacterium tuberculosis such as TbRa12, TbH9, TbRa35, Tb38-1, Erd14, DPV, MTI, MSL, mTTC2, and hTCC1. Proteins for Mycobacterium tuberculosis include fusion proteins and variants thereof, and at least two, preferably three, polypeptides of Mycobacterium tuberculosis are fused into a larger protein. Preferred fusions include Ra12-TbH9-Ra35, Erd14-DPV-MTI, DPV-MTI-MSL, Erd14-DPV-MTI-MSL-mTCC2, Erd14-DPV-MTI-MSL, DPV-MTI-MSL-mTCC2, TbH9. -DPV-MTI is included. Most preferred antigens for Chlamydia include, for example, high molecular weight protein (HWMP), ORF3, and putative membrane protein (Pmps). Preferred bacterial vaccines include Streptococcus pneumoniae (eg, capsular polysaccharides and conjugates thereof, PsaA, PspA, streptolysin, choline binding protein), and protein antigen pneumolysin (Non-patent Document 1) and mutant detoxification derivatives thereof. Antigens derived from Streptococcus, including Other preferred bacterial vaccines include H.P. Influenza B bacteria (“Hib”, eg, PRP and its conjugates), unclassifiable H. Included are antigens from influenza, such as OMP26, high molecular weight adhesins, P5, P6, D and D lipoproteins, and fimbrin and fimbrin derived peptides, or hemophilus species including several copies of variants or fusion proteins thereof. Derivatives of hepatitis B surface antigen are well known in the art and include, in particular, PreS1 and PreS2S antigens. In one preferred embodiment, the vaccine formulation of the invention comprises the HIV-1 antigen, gp120, particularly when expressed in CHO cells. In a further embodiment, the vaccine formulation of the invention comprises gD2t as defined herein above.

  In addition to the delivery of the substances listed above, the infusion device 100 can be used to retrieve the substance from the patient or to monitor the level of substance in the patient. Examples of substances that can be monitored or collected include blood, interstitial fluid, or plasma. The recovered material can then be analyzed for analytes, glucose, drugs, and the like.

  As described above, according to one embodiment, infusion device 100 includes a rotor 136 and a needle cover portion 112 of needle cover 114, shown separately in FIGS. 17 and 18, respectively. The rotor 136 includes an activation protrusion 256, a drive spring holder 260, and a safety holding protrusion 296. Needle cover portion 112 includes an eyelet 512 having an eyelet opening 516 and a pair of flanges 520. The spacing between the flanges 520 closely corresponds to the width of the drive spring holder 260, so that when the rotor 136 is in the pre-activated position and the needle cover portion 112 engages the needle manifold 154, FIG. As shown, the flange 520 engages the drive spring holder 260 to maintain the rotor 136 in a pre-activated position. In order to allow rotation of the rotor 136 from the previously activated position to the activated position, the needle cover portion 112 must first be disconnected from engagement with the drive spring holder 260.

  As described above, according to one embodiment, the needle cover portion 112 is attached to the needle manifold 154 via a press fit. Since the portion of the needle cover portion 112 that contacts the needle manifold 154 has flexibility, such press fitting is facilitated. However, such flexibility may be undesirable for the function of the flange 520 to maintain the rotor 136 in a pre-activated position. Thus, the needle cover portion 112 can be manufactured using a two-shot molding process, and therefore the portion of the needle cover portion 112 that contacts the needle manifold 154 remains flexible to accommodate press fit. The flange 520 can be sufficiently rigid to maintain the rotor 136 in a pre-activated position.

  In order to avoid the cost of such a two-moulding process and prevent premature activation of the injection device, alternative embodiments of the rotor and needle cover are shown in FIGS. 20A, 20B, 21A, 21B, and Shown in FIGS. 20A and 20B are a perspective view and a side view of one embodiment of a needle cover clip 560 that engages the needle cover portion 112 to form the needle cover 114. As shown in FIG. 20A, the needle cover clip 560 includes a body portion 564, a handle portion 568, a cantilever clip portion 572, and a lockout pin 576 that extends substantially perpendicular to the body portion 564. Needle cover clip 560 is combined with needle cover portion 112 by inserting cantilevered clip portion 572 into eyelet opening 516. As discussed in more detail below, according to one embodiment, the eyelet 512 is sufficiently flexible to allow rotation of the needle cover clip 560 relative to the needle cover portion 112.

  Materials for needle cover clip 560 can include, but are not limited to, polycarbonate or other thermoplastics, and / or metals such as stainless steel. According to one embodiment, the needle cover clip 560 includes a plurality of materials. For example, the body portion 564, the handle portion 568, and the cantilevered clip portion 572 can be made from polycarbonate and the lockout pin 576 can be made from a metal such as stainless steel. As will be appreciated by those skilled in the art, the material and sizing for lockout pin 576 should be sufficiently rigid to prevent premature rotation of the rotor.

  21A and 21B are perspective views of both sides of an alternative embodiment of the rotor 580. FIG. The rotor 580 includes an activation protrusion 584, a drive spring holder 588, and a safety holding protrusion 592. The functions of the activation protrusion 584, the drive spring holder 588, and the safety retaining protrusion 592 are similar to the corresponding portions described above with respect to the rotor 136. Therefore, for the sake of brevity, further description of these portions of the rotor 580 is omitted to the extent they are similar. The drive spring holder 588 includes an engagement slot 596 on the lower surface of the rotor 580 of FIG. As discussed in more detail below, the shape of the engagement slot 596 corresponds to the lockout pin 576 so that the lockout pin 576 can be inserted into the engagement slot 596.

  22 and 23 illustrate an embodiment of the infusion device 100 in which a release liner covers the adhesive pad 264 releasably. In FIG. 22, the release liner 600 has a liner opening 604 that is aligned with the needle cover opening 262 in the adhesive pad 264, the needle opening 156 of the safety mechanism 108, and the opening 300 in the lower container 104. Thus, the needle cover portion 112 can be inserted into the liner opening 604 and brought into contact with the needle manifold 154. According to another embodiment, as discussed in more detail below, these openings (eg, 262, 156, and 300) are such that the body portion 564 of the needle cover clip 560 is substantially parallel to the release liner 600. When the needle cover clip 560 is rotated, the lockout pins pass through these openings and engage the engagement slot 596 of the rotor 580 when the rotor 580 reaches the pre-activated position. It is big enough.

  In contrast, in FIG. 23, the release liner 608 has an auxiliary liner opening 612 that is aligned with the respective auxiliary opening in the adhesive pad 264, the safety mechanism 108, and the lower container 104, and thus When the body portion 564 of the needle cover clip 560 is rotated so that it is substantially parallel to the release liner 600, the lockout pins pass through their respective auxiliary openings and the rotor 580 is in a pre-activated position. When it arrives, it engages with the engagement slot 596 of the rotor 580. Such aligned auxiliary openings can provide additional support to lockout pin 576 to withstand rotation of rotor 580.

  Referring to FIGS. 24 and 25, the rotor 580 is in a pre-activated position and the needle cover portion 112 is disposed on the needle manifold 154 and covers the needle 152. In FIG. 24, the cantilever clip portion 572 is disposed within the eyelet opening 516 of the eyelet 512. Eyelet 512 is sufficiently flexible to allow rotation of cantilevered clip portion 572 within eyelet opening 516. When the needle cover clip 560 is rotated so that the body portion 564 of the needle cover clip 560 is substantially parallel to the bottom surface of the lower container 104, the lockout pin 576 is removed from the release liner 600, the adhesive pad 264, the safety mechanism 108, And through aligned openings in lower container 104 (eg, 262, 156, and 300), rotor 580 receives lockout pin 576 and engagement slot 596, as shown in FIG. Engagement of lockout pin 576 within engagement slot 596 of rotor 580 prevents rotor 580 from rotating from a previously activated position, thereby preventing premature activation. Such a feature is advantageous, for example, when shipping and storing the injection device 100.

  As shown in FIGS. 24 and 25, when the rotor 580 is in the pre-activated position and the needle cover portion 112 is placed in the needle manifold 154, the flange 520 is engaged with the drive spring holder 588 of the rotor 580. Match. This feature provides positioning of the orientation of the needle cover 114 relative to the lower container 104. In other words, the engagement between the flange 520 and the drive spring holder 588 aligns the needle cover 114 and the lockout pin 576 and engages the engagement slot 596 of the rotor 580.

  To prepare the infusion device 100 for activation, the user rotates the needle cover clip 560 away from the lower container 104, disconnects the lockout pin 576 from the engagement slot 596 of the rotor 580, and the handle portion 568. To detach needle cover portion 112 from needle manifold 154, thereby uncovering needle 152.

  According to one embodiment, the liner opening 604 is larger than the eyelet 512 but smaller than the flange 520 and the needle cover opening 262 of the adhesive pad 264 is sized larger than the needle cover portion 112. During assembly of the infusion device, the assembler first press fits the needle cover portion 112 onto the needle manifold 154 and then attaches the adhesive pad 264 and release liner 600 to the lower container 104. After the adhesive pad 264 and release liner 600 are installed, the eyelet 512 passes through the liner opening 604 and the flange 520 contacts the release liner 600. The assembler then inserts the cantilevered clip portion 572 into the eyelet opening 516. In such embodiments, the release liner 600 is captured between the needle cover clip 560 and the needle cover portion 112 so that when the needle cover 114 is removed from the injection device, the release liner 600 is also automatically removed. , Thereby increasing patient convenience, ease of use, and efficiency. Further, by optionally maintaining the connection between the needle cover 114 and the release liner (eg, 600) after removal from the infusion device 100, in the described embodiment, by simplifying the disposal itself, Patient convenience, ease of use, and efficiency can be further increased.

  After removing the needle cover 114 and release liner 600, the user activates the infusion device 100 by depressing the activator button 128 as described above.

  According to one embodiment (not shown), the needle cover clip and the needle cover portion are integrally formed as a single structure, for example using a two piece molding process. In such embodiments, the needle cover clip has a substantially fixed angle with respect to the needle cover portion. In other words, the needle cover clip does not rotate relative to the needle cover portion.

  Although only some exemplary embodiments of the present invention have been described in detail above, many modifications are possible in the exemplary embodiments without substantially departing from the novel teachings and advantages of the present invention. This will be easily understood by those skilled in the art. Accordingly, all such modifications are intended to be included within the scope of the appended claims and their equivalents.

Claims (11)

  1. A drug delivery device comprising:
    A main body in which a reservoir for storing medicines is arranged;
    A needle that penetrates the patient's skin, the needle providing a pathway for the medicament between the reservoir and the patient;
    A needle cover having a first portion that covers the needle and a second portion that is movable from a first position that prevents activation of the device to a second position that allows activation of the device; and, rotating said first portion and said second portion Ri insertable der through the same opening in the body, the second portion, in order to prevent the activation, which is disposed inside the body a needle cover Ru engageable der the child,
    A device comprising:
  2.   The device of claim 1, wherein the second portion is adapted to prevent activation of the device until the first portion is removed to expose the needle.
  3.   The device of claim 1, wherein the second portion comprises a pin.
  4.   The device of claim 1, wherein the second portion extends directly from the first portion.
  5.   The device according to claim 1, wherein the first portion and the second portion are integrally formed as an integral structure.
  6.   The device of claim 1, wherein the needle cover comprises a needle cover clip that is rotatable relative to the first portion.
  7. The device of claim 6 , wherein the second portion is disposed on the needle cover clip.
  8. A drug delivery device comprising:
    A main body in which a reservoir for storing medicines is arranged;
    A needle that penetrates the patient's skin, the needle providing a pathway for the medicament between the reservoir and the patient;
    Have a second portion that is movable to a second position that allows the activation of the device from a first position preventing the activation of the first portion and the device for covering the injection needle, said second portion , in order to prevent the activation, and the needle cover Ru engageable der the rotor disposed inside the body,
    With
    The device wherein the second portion extends directly from the first portion.
  9. The device of claim 8 , wherein the second portion is adapted to prevent activation of the device until the first portion is removed to expose the needle.
  10. The device according to claim 8 , wherein the first part and the second part are integrally formed as an integral structure.
  11. 9. The device of claim 8 , wherein the first portion and the second portion are insertable into the same opening in the body.
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Publication number Priority date Publication date Assignee Title
US7250037B2 (en) * 2002-07-22 2007-07-31 Becton, Dickinson And Company Patch-like infusion device
EP2609946B1 (en) * 2003-08-12 2018-05-16 Becton, Dickinson and Company Patch-like infusion device with shielding member
US8945071B2 (en) * 2010-09-02 2015-02-03 Becton, Dickinson And Company Self-injection device having needle cover with activation preventer

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