The present disclosure relates to an injection device for injecting a drug product, such as a therapeutic agent, into a patient.
One of the most common routes of administration for drug products is by injection, such as intravenous, subcutaneous, or intramuscular injection. A syringe containing a drug product is often used for the injection, which is often carried out by trained medical personnel. In certain instances, a patient is trained in the use of the syringe to allow for self-injection. Moreover, certain drug products are formulated in pre-filled syringes for patient use, to avoid the need for the patient to fill the syringe. Some patients, however, may be averse to carrying out self-injection with a manual syringe, particularly if the patient lacks the dexterity to manipulate the syringe to fill the syringe and inject the drug product from the syringe. Automatic injection devices offer an alternative to a manual syringes for delivering a drug product, as automatic injection devices are easier to use.
The present disclosure provides injection devices with an end of dose indicator assembly that is simultaneously viewable from at least two different directions. The end of dose indicator assembly may be a binary indicator.
In an embodiment, the present disclosure provides an injection device including a housing having an internal volume and a viewing portion. A movable seal is disposed in the internal volume and is movable from an initial position to an injection end position to urge a drug product out of the housing. An indicator assembly is disposed in the internal volume and includes a dose end indicator. The indicator assembly is biased from a dose remaining position toward a dose end position where the dose end indicator is visible through the viewing portion. A release mechanism releasably holds the indicator assembly in the dose remaining position and is linked to the movable seal such that the movable seal reaching the injection end position causes the release mechanism to release the indicator assembly to the dose end position.
The foregoing and other objects, features and advantages of the exemplary embodiments will be more fully understood from the following description when read together with the accompanying drawings, in which:
The present disclosure provides injection devices with an indicator assembly including a dose end indicator viewable from at least both a side and a top of the injection device for indicating when an injection is completed. The indicator assembly is disposed in a housing of the injection device and is biased from a dose remaining position toward a dose end position where the dose end indicator is simultaneously visible from two or more different viewing positions through a viewing portion of the housing. A release mechanism releasably holds the indicator assembly in the dose remaining position. A movable seal that is linked to the release mechanism moves to an injection end position to release the indicator assembly into the dose end position.
The devices presented herein can be used for injecting a variety of drug products into a patient. In one embodiment, the injection device can be configured in the form of an automatic injection device. In some embodiments, the automatic injection device is configured in the form of a pen, i.e., a portable autoinjector that enables an individual to administer a dosage of a drug product. In other embodiments, the injection device can be configured as a traditional syringe or other type of injection device for injecting drug products.
As used herein, an “automatic injection device” (or “autoinjector”) is intended to refer to a device that enables an individual (also referred to herein as a user or a patient) to self-administer a dosage of a drug product. The automatic injection device differs from a standard syringe by the inclusion of a mechanism for automatically inserting the needle at an injection site, automatically delivering the drug product to the individual by injection, and automatically retracting the needle from the injection site when the mechanism is engaged.
As used herein, the term “drug product” refers to a composition intended for use in medical diagnosis, cure, treatment, or prevention of disease. A drug product may be a therapeutic agent or a combination of therapeutic agents. A drug product may include a therapeutic protein, for example, a peptide or antibody, or antigen-binding portion thereof. A drug product may include an anesthetic, steroid, and/or any other therapeutic agent(s). In one embodiment, a drug product represents a mixture of two or even more pharmacologically active agents. In some embodiments, the drug product is a liquid therapeutic agent which includes one or more biological agents, such as a protein, or antibody. For example, the liquid therapeutic agent can be a monoclonal antibody targeting interleukin 23A, such as risankizumab. In yet another example embodiment, the liquid therapeutic agent may comprise an antibody drug conjugate (ADC). Additional details regarding possible therapeutic agents, including are provided in U.S. Pat. No. 8,679,061, the contents of which are incorporated by reference herein in its entirety. The drug product may have any suitable volume, for example between about 0.5 ml and about 4 ml, e.g. about 2.25 ml.
As used herein, the term “proximal” refers to the portion or end of an injection device or component in the injection device furthest from an injection site of the user when the device is held against the person for an injection.
As used herein, the term “distal” refers to the portion or end of an injection device or a component of the injection device closest to an injection site of the user during an injection.
As used herein, the term “dose end” or “end of dose” refers to a movable seal, for example, a bung or a piston reaching a termination point within the barrel of a syringe following compression of a drug product through an aperture of the syringe to deliver a volume of the drug product for treatment of a patient for which the drug product is indicated.
The present disclosure provides injection devices with a binary end-of-dose (“EOD”) indicator that does not deploy until the injection is complete. In some embodiments, the indicator is incorporated in a single-use automatic injection device to alert a user that the injection is complete, and that the injection device may be discarded. In some embodiments, the indicator is incorporated in a re-usable injection device, such as an infusion pump, to indicate that a complete dose has been delivered and the user may, for example, replace a drug product container holding the dose.
Referring now to the drawings, and more particularly to
In some embodiments, the injection device 100 may not include a cap. In such embodiments the viewing portion 111 may be formed in the proximal end 112 of the housing 110 through at least three viewing surfaces 114A, 114B, 114C to allow a user to view the indicator assembly 120 while holding the injection device 110 in hand. The same principles of the viewing portion 111 described with respect to the cap 114 are equally applicable to an embodiment of the injection device 100 formed without a cap.
The viewing portion 111 may be formed as an aperture or other opening in the housing 110 that is partially or fully covered by a viewing window 115. In some embodiments, the viewing window 115 is a generally translucent material and substantially transparent to allow a user to clearly view the indicator assembly 120 through the viewing portion 111. The viewing portion 111 may be formed, for example, about a longitudinal axis LA of the housing 110 extending through the proximal end 112 and the distal end 113. In some embodiments, the viewing portion 111 has a viewing portion width VPW that extends on an arc that is defined between approximately 1° and approximately 180° about the longitudinal axis LA to allow visibility through the viewing portion 111 from a variety of angles. In some embodiments, the viewing portion 111 has a viewing portion length VPL that is equal to a radius R of the housing 110, relative to the longitudinal axis LA.
A movable seal 250, for example a piston or a bung in
The movable seal 250 is movable from an initial position, illustrated in
With further reference to
In some embodiments, the indicator assembly 120 includes a dome 224 with a first portion 122 and a second portion 223, with each portion 122, 223 being a respective half of the dome 224. The first portion 122 is visible through the viewing portion 111 when the indicator assembly 120 is in the dose remaining position and the second portion 223, which includes the dose end indicator 221, is visible through the viewing portion 111 when the indicator assembly 120 is in the dose end position. In some embodiments, some of the first portion 122 may also be visible through the viewing portion 111 when the indicator assembly 120 is in the dose end position. The first portion 122 may include a visual indicator 124 that is visually distinct from the dose end indicator 221. The visual indicator 124 may be a first color or other type of visual marking, such as a symbol, that is visually distinct from the dose end indicator 221. The visual indicator 124 may be, for example, a light or white colored portion while the dose end indicator 221 is a dark color, such as black, red, etc., that is visually distinct from the visual indicator 124. While the visual indicator 124 is illustrated as having a first color and the dose end indicator 221 is illustrated as having a second color that is different from the first color, in some embodiments the visual indicator 124 may be a symbol or text, such as an X or the phrase “dose remaining,” while the dose end indicator 221 is a different symbol or text that conveys that the dose has ended, such as a checkmark or the phrase “dose completed.” It should thus be appreciated that there are many different ways in which the visual indicator 124 may convey that there is at least some dose of drug product remaining and the dose end indicator 221 may convey to a user that the dose has been delivered.
In some embodiments, the first portion 122 and the second portion 223 of the dome 224 may be integral or otherwise connected with one another to move together, i.e., static relative to one another, so movement of the dome 224 causes movement of both of the portions 122, 223. In some embodiments, the indicator assembly 120 may be disposed on one side of a partition 225 disposed in the internal volume V to separate the indicator assembly 120 from a cavity 226 in the housing 110 that houses the movable seal 250 and other components of the injection device 100.
In some embodiments, an indicator assembly biaser 231, for example, illustrated as a torsion spring, bears on the indicator assembly 120 to bias the indicator assembly 120 from the dose remaining position toward the dose end position. In some embodiments, the biaser 231 is placed in an indicator assembly biaser cavity 232 formed adjacent to the partition 225. The biaser 231 may store, for example, rotational energy in a constrained position that, when released, pivots a portion or all of the indicator assembly 120 about the longitudinal axis LA, which thus defines a pivoting axis of the indicator assembly 120. While the exemplary embodiment illustrated in
Referring specifically now to
The release mechanism 240 may be coupled or linked directly or indirectly to the movable seal 250 by, for example, a tensioner 242, illustrated as a monofilament fiber or wire. In some embodiments, the tensioner 242 is slacked when the movable seal 250 is in the initial position, as illustrated in
In some embodiments, a needle shroud or other element may also be directly or indirectly coupled to or linked to the movable seal 250, independently of or dependently on linkage of the indicator assembly 120 to the movable seal 250, and deploys when the movable seal 250 reaches the injection end position. In this manner, the needle shroud may be deployed in temporal sequence with the dose end position of indicator assembly. Many types of needle shrouds are conventional and may be readily incorporated in the injection device 100. Similarly, the injection device 100 may include a syringe carrier holding a syringe that translates along the longitudinal axis LA with the movable seal 250 to urge drug product out of the housing 110. Many types of syringe carriers are conventional and may be readily incorporated in the injection device 100.
A stop 228, illustrated as a surface, is positioned in the internal volume V adjacent to the indicator assembly 120 such that the stop 228 prevents the indicator assembly 120 from moving past the dose end position. For example, the stop 228 may be placed in a rotation path of the dome 224 such that the second portion 223 hits the stop 228 when the indicator assembly 120 reaches the dose end position, with the abutment of the second portion 223 against the stop 228 preventing the dome 224 from further rotating.
To use the injection device 100, a user depresses or otherwise actuates an element, such as a firing button or plunger or a component at a distal end 113 of the injector (e.g. a distal end of a needle shroud), so the movable seal 250 translates along the longitudinal axis LA toward the distal end 113 to urge drug product out of the housing 110 through, for example, a needle 190. As the movable seal 250 translates, or otherwise moves, the tensioner 242 linking the release mechanism 240 to the movable seal 250 becomes taut, if not already taut, and allows the movable seal 250 to pull the release mechanism 240 toward the distal end 113. When the movable seal 250 reaches the injection end position in which the movable seal 250 has fully moved to urge drug product out of the housing 110, the release mechanism 240 releases the indicator assembly 120 to the dose end position by, for example, pulling out of the release mechanism opening 241 and thus out of contact with the contact surface 227. When the release mechanism 240 releases the indicator assembly 120, the bias on the indicator assembly 120 is configured to move the indicator assembly 120 to the dose end position where the dose end indicator 221 is visible through the viewing portion 111 of the housing 110, alerting a user that the dose has ended. The indicator assembly 120 contacting the stop 228, or another element, upon reaching the dose end position may be configured to provide a vibration, or other type of tactile feedback, in the housing 110. The indicator assembly 120 contacting the stop 228, or another element, upon reaching the dose end position may also, or alternatively, may be configured to provide a “click” or other type of audible feedback. While the movement of the movable seal 250 is illustrated as pulling the release mechanism 240, in some embodiments the movable seal 250 reaching the injection end position pushes, or causes pushing of, the release mechanism 240 to release the indicator assembly 120.
Referring now to
During the injection, a movable seal 250′ translates along the longitudinal axis LA to urge drug product out of the housing 110′. When the movable seal 250′ translates along the longitudinal axis LA to the injection end position, the release mechanism 240′ releases the injection assembly 120′. After the release mechanism 240′ releases the injection assembly 120′, the injection assembly 120′ rotates about the firing button 380 from the dose remaining position to the dose end position where one or more dose end indicators 221′, rather than one or more visual indicators 124′, are visible through the viewing portion 111′. As illustrated in
In another exemplary embodiment illustrated in
The injection devices 100, 300, 400 disclosed herein provide an indicator assembly 120, 120′, 120″ with a dose end indicator 221, 221′, 221″ that becomes visible through the viewing portion 111, 111′, 111″ when the movable seal 250, 250′ reaches the injection end position. In this sense, the indicator assembly 120, 120′, 120″ is a binary indicator that conveys that the movable seal 250, 250′ has reached the injection end position, which generally corresponds to the injection ending and the dose of drug product being urged out of the housing 110, 110′, via the release mechanism 240, 240′ releasing the indicator assembly 120, 120′, 120″ to the dose end position when the movable seal 250, 250′ reaches the injection end position. In some embodiments, such an indicator assembly 120, 120′, 120″ may forego so-called “dose progress indicators,” which indicate how much dose is remaining in the injection and may be confusing to users. The viewing portion 111, 111′ and the indicator assembly 120, 120′, 120″ may also be placed adjacent to the proximal end 112, 112′ of the injection device 100, 300, 400, rather than a middle portion of the device 100, 300, 400, so the indicator assembly 120, 120′, 120″ is simultaneously viewable from a variety of viewing directions and angles while performing the injection. In some embodiments, the indicator assembly 120, 120′, 120″ is viewable from at least two different viewing directions. Further, the release mechanism 240, 240′ releasably holding the indicator assembly 120, 120′, 120″ may be linked to the movable seal 250, 250′ such that the release mechanism 240, 240′ releases the indicator assembly 120, 120′, 120″ with little, if any, detrimental effect, such as friction sticking of the movable seal 250, 250′, on the movement of the movable seal 250, 250′ to the injection end position.
In some embodiments, the injection device 100, 300, 400 may include one or more other indicators in addition to the indicator assembly 120, 120′, 120″. For example, the injection device 100, 300, 400 may include an additional indicator that “clicks” or otherwise indicates when the injection has finished and the dose of drug product has been urged out of the housing 110, 110′. The additional indicator may be, for example, a button or other type of element that pops out of the housing 110, 110′ when the injection finishes. Thus, the additional indicator may provide a tactile and/or audible indication to alert a user that the injection has finished.
With reference now to
In some embodiments, the indicator assembly 520 is biased by a biaser 531, illustrated as a compression spring, from a dose remaining position, in which one or more visual indicators 524, illustrated as X's, of a first portion 522 of the indicator assembly 520 are visible through the viewing portion 511 as illustrated in
In another exemplary embodiment illustrated in
In some embodiments, and referring now to
In some embodiments a first portion of an indicator assembly is movable relative to a second portion of the indicator assembly. For example, one of the portions may be viewable through the viewing portion of the housing when the indicator assembly is in the dose remaining position. When the indicator assembly reaches the dose end position, one of the portions may move out of, or alternatively into, view through the viewing portion to indicate that the dose has been ejected from the housing.
From the foregoing, it should be appreciated that the injection devices 500, 600 provide a binary end of dose indicator assembly 520, 520′ that can convey to users that a dose of drug product has been injected without indicating progress of the injection. By having the indicator assembly 520, 520′ pivoted about the pivot axis PA extending orthogonally, or in some embodiments transversely, to the longitudinal axis LA, the indicator assembly 520, 520′ can be formed with a relatively small size. The relatively small size of the indicator assembly 520, 520′ may assist with, for example, assembly of the injection device 500, 600 and allow other components to fit within the injection devices 500, 600.
Referring now to
The release mechanism 840 may be disposed in a release mechanism opening 826 formed in the partition 825 and at least partially surrounded by, or embedded within, a plug 841 that seals the release mechanism opening 826 and maintains fluid isolation between the first fluid space S1 and the second fluid space S2. In some embodiments, an indicator assembly 820, which may be similar to any of the previously described indicator assemblies, is disposed in the first fluid space S1 of the housing 810 and sealed off from the second fluid space S2 of the housing 810 in which the movable seal 850 is disposed. The release mechanism 840 may be linked to the movable seal 850 by a tensioner 870, which may be a monofilament wire or similar element, such that movement of the movable seal 850 to an injection end position causes the release mechanism 840 to release the indicator assembly 820. The injection device 800 further includes a valve 890 that extends into the second fluid space S2 of the housing 810 to, for example, selectively inject pressurized fluid into the second fluid space S2 of the housing 810, increasing the fluid pressure in the second fluid space 82 and driving the movable seal 850 when the valve 890 is activated.
When the valve 890 activates, pressurized fluid enters the second fluid space S2 of the housing 810 and urges the movable seal 850 toward the injection end position. As the movable seal 850 moves toward the injection end position, the movable seal 850 pressurizes the third fluid space S3 to urge drug product from the housing 810 and pulls the release mechanism 840 via the tensioner 870. Once the movable seal 850 reaches the injection end position, the release mechanism 840 releases the indicator assembly 820 to a dose end position so a user may see that the injection has ended. In some embodiments, the movable seal 850 fully pulls the release mechanism 840 through the release mechanism opening 826 upon reaching the injection end position, establishing a path for the fluid pressure in the second fluid space S2 to vent and equalize with the pressure in the first fluid space S1. In some embodiments, the burst of fluid venting into the first fluid space S1 may partially or fully drive the indicator assembly 820 to the dose end position. Alternatively, in some embodiments, at least a portion of the release mechanism 840 remains in the release mechanism opening 826 upon the movable seal 850 reaching the injection end position, maintaining the fluid separation between the first fluid space S1 and the second fluid space S2.
Referring now to
In another embodiment, illustrated in
In another embodiment, illustrated in
It should be appreciated from the foregoing that indicator assemblies disclosed herein may be used to indicate an injection has ended in injection devices that utilize pressurized fluid, rather than solid elements, to drive the injection. Thus, the indicator assemblies disclosed herein may be incorporated and function in many different types of injection devices, unlike many conventional indicators.
While the previously described injection devices 100, 300, 400, 500, 600, 800 are configured so their respective indicators are binary EOD indicators, in some embodiments the injection devices 100, 300, 400, 500, 600, 800 are configured so their respective indicators convey injection progress.
To convey progressive injection progress, and referring now to
To convey step-wise injection progress, and referring now to
In describing exemplary embodiments, specific terminology is used for the sake of clarity. For purposes of description, each specific term is intended to at least include all technical and functional equivalents that operate in a similar manner to accomplish a similar purpose. Additionally, in some instances where a particular exemplary embodiment includes a plurality of system elements or method steps, those elements or steps may be replaced with a single element or step. Likewise, a single element or step to may be replaced with a plurality of elements or steps that serve the same purpose. Further, where parameters for various properties are specified herein for exemplary embodiments, those parameters may be adjusted up or down by 1/20th, 1/10th, ⅕th, ⅓rd, ½nd, and the like, or by rounded-off approximations thereof, unless otherwise specified. Moreover, while exemplary embodiments have been shown and described with references to particular embodiments thereof, those of ordinary skill in the art will understand that various substitutions and alterations in form and details may be made therein without departing from the scope of the invention. Further still, other aspects, functions and advantages are also within the scope of the invention.
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/682,592, filed Jun. 8, 2018, the disclosure of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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62682592 | Jun 2018 | US |