NZ739694B2 - Automatic injection devices having overmolded gripping surfaces - Google Patents
Automatic injection devices having overmolded gripping surfaces Download PDFInfo
- Publication number
- NZ739694B2 NZ739694B2 NZ739694A NZ73969412A NZ739694B2 NZ 739694 B2 NZ739694 B2 NZ 739694B2 NZ 739694 A NZ739694 A NZ 739694A NZ 73969412 A NZ73969412 A NZ 73969412A NZ 739694 B2 NZ739694 B2 NZ 739694B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- overmolded
- exemplary
- gripping
- body portion
- overmolded gripping
- Prior art date
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/3157—Means providing feedback signals when administration is completed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
injection device (100) is disclosed. The injection device (100) comprises: a first body portion (116); a second body portion (118) cooperatively engageable to the first body portion (116) to form a gripping region of the device (100) at a proximal portion (106) and to define an injection region of the device at a distal portion (104); a first overmolded gripping surface (154) disposed along a first side of the gripping region; a second overmolded gripping surface (156) disposed along a second side of the gripping region opposite the first overmolded gripping surface (154); a first recessed portion (122) abutting the first overmolded gripping surface (154); a second recessed portion (124) abutting the second overmolded gripping surface (156); a firing button (120) that extends from a recessed surface (126) of the first body portion (116); an inspection window (128) disposed in the injection region to allow a user to view a content of a container disposed within the injection device (100); a removable cap (164) couplable to the distal portion (104) of the device (100), the removable cap (164) having a concave cutout portion (168) for accommodating part of the inspection window (128); and a third overmolded gripping surface (165) disposed over an exterior surface of the removable cap (164). f the device at a distal portion (104); a first overmolded gripping surface (154) disposed along a first side of the gripping region; a second overmolded gripping surface (156) disposed along a second side of the gripping region opposite the first overmolded gripping surface (154); a first recessed portion (122) abutting the first overmolded gripping surface (154); a second recessed portion (124) abutting the second overmolded gripping surface (156); a firing button (120) that extends from a recessed surface (126) of the first body portion (116); an inspection window (128) disposed in the injection region to allow a user to view a content of a container disposed within the injection device (100); a removable cap (164) couplable to the distal portion (104) of the device (100), the removable cap (164) having a concave cutout portion (168) for accommodating part of the inspection window (128); and a third overmolded gripping surface (165) disposed over an exterior surface of the removable cap (164).
Description
AUTOMATIC INJECTION DEVICES HAVING OVERMOLDED GRIPPING
SURFACES
CROSS-REFERENCE TO RELATED APPLICATION
This is a divisional application of New Zealand Patent Application No. 722287, the
disclosure of which is incorporated in this divisional application in its entirety by reference.
BACKGROUND
[0001a] Automatic injection devices offer an alternative to manually-operated syringes for
administering therapeutic agents into patients’ bodies and allowing patients to self-administer
therapeutic agents. Automatic injection devices may be used to administer medications under
emergency conditions, for example, to administer epinephrine to counteract the effects of a
severe allergic reaction. Automatic injection devices have also been described for use in
administering anti-arrhythmic medications and selective thrombolytic agents during a heart
attack. See, for example, U.S. Patent Nos. 3,910,260; 4,004,577; 4,689,042; 4,755,169; and
4,795,433, the entire contents of which are incorporated herein in their entirety by reference.
Various types of automatic injection devices are also described in, for example, U.S. Patent Nos.
3,941,130; 4,261,358; 5,085,642; 5,092,843; 5,102,393; 5,267,963; 6,149,626; 6,270,479; and
6,371,939; and International Patent Publication No. WO/2008/005315, the entire contents of
which are incorporated herein in their entirety by reference.
Conventionally, an automatic injection device houses a syringe and, when operated,
causes the syringe to move forwardly and a needle to project from the housing so that a
therapeutic agent contained in the syringe is ejected into a patient’s body.
SUMMARY OF INVENTION
Accordingly, the present invention provides in one aspect an injection device,
comprising:
a first body portion;
a second body portion cooperatively engageable to the first body portion to form a
gripping region of the device at a proximal portion thereof and to define an injection region of
the device at a distal portion thereof;
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a first overmolded gripping surface disposed along a first length of the gripping region;
a second overmolded gripping surface disposed along a second length of the gripping
region opposite the first overmolded gripping surface;
a first recessed portion abutting the first overmolded gripping surface;
a second recessed portion abutting the second overmolded gripping surface;
a firing button that extends from a recessed surface of the first body portion;
an inspection window disposed in the injection region to allow a user to view a content
of a container disposed within the injection device;
a removable cap couplable to the distal portion of the device, the removable cap having
a concave cutout portion for accommodating part of the inspection window; and
a third overmolded gripping surface disposed over an exterior surface of the removable
cap.
Exemplary embodiments provide automatic injection devices, housing components for
automatic injection devices and methods for fabricating the same. An exemplary housing of an
automatic injection device may be overmolded with one or more gripping surfaces to facilitate
gripping and manipulation of the automatic injection device by a user when performing an
injection. In an exemplary embodiment, an overmolded left gripping surface may extend along a
left side of the housing and an overmolded right gripping surface may extend along a right side
of the housing opposite to the left side.
In accordance with an exemplary embodiment, an automatic injection device is provided
with a housing enclosing a cavity for accommodating a container. A first overmolded gripping
surface is provided to extend longitudinally along a portion of the housing on a first exterior
surface of the housing. A second overmolded griping surface is provided to extend
longitudinally along a portion of the housing on a second exterior surface of the housing
opposite to the first exterior surface.
In an exemplary embodiment, the first and second overmolded gripping surfaces on the
housing are formed of a first material having a first touch perception, and non-gripping surfaces
on the housing are formed of a second material having a second touch perception. In an
exemplary embodiment, the first and second overmolded gripping surfaces on the housing are
formed of a first material having a first hardness, and non-gripping surfaces on the housing are
formed of a second material having a second higher hardness.
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In an exemplary embodiment, the automatic injection device includes a removable distal
cap for protectively covering an injection needle couplable to the container, an exterior surface
of the distal cap including an overmolded gripping surface for facilitating gripping and removal
of the distal cap. In an exemplary embodiment, the automatic injection device includes a firing
button protruding from an aperture in the housing and including an overmolded contact surface
for facilitating actuation of the firing button by a user. In an exemplary embodiment, the
automatic injection device includes a proximal terminal end for covering a proximal end of the
automatic injection device, the proximal terminal end having an overmolded exterior surface. In
an exemplary embodiment, a top surface of the proximal terminal end includes a recessed
surface for directing and facilitating accommodation of a user’s hand or finger for gripping the
automatic injection device.
In accordance with another exemplary embodiment, a method is provided for assembling
an automatic injection device. The method includes providing a housing enclosing a cavity for
accommodating a container. The method includes overmolding, on the housing, a first gripping
surface extending longitudinally along a portion of the housing on a first exterior surface of the
housing. The method also includes overmolding, on the housing, a second gripping surface
extending longitudinally along a portion of the housing on a second exterior surface of the
housing opposite to the first exterior surface.
In an exemplary embodiment, the first and second gripping surfaces on the housing are
formed of a first material having a first touch perception, and non-gripping surfaces on the
housing are formed of a second material having a second touch perception. In an exemplary
embodiment, the first and second gripping surfaces on the housing are formed of a first material
having a first hardness, and non-gripping surfaces on the housing are formed of a second
material having a second higher hardness.
In an exemplary embodiment, the method includes overmolding a gripping surface on
an exterior surface of a distal cap to facilitate gripping and removal of the distal cap, and
coupling the distal cap to a distal end of the housing for protectively covering an injection
needle. In an exemplary embodiment, the method includes overmolding a gripping surface on a
firing button to facilitate activation of the firing button, and providing the firing button within
the cavity so that part of the firing button protrudes from an aperture in the housing.
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In an exemplary embodiment, the method includes overmolding a gripping surface on
an exterior surface of a proximal terminal end, and coupling the proximal terminal end to a
proximal end of the housing. In an exemplary embodiment, a top surface of the proximal
terminal end includes a recessed surface for directing a user’s hand or finger for gripping the
automatic injection device.
In accordance with another exemplary embodiment, an automatic injection device is
provided including a housing enclosing a cavity for accommodating a container. The housing
includes a first overmolded gripping region, a second overmolded gripping region, and a
recessed region abutting the first and second overmolded gripping regions.
In an exemplary embodiment, the recessed region is disposed between the first and
second overmolded gripping regions. In an exemplary embodiment, a width of the housing at
the recessed region is smaller than a width of the housing at the first overmolded gripping region
and a width of the housing at the second overmolded gripping region. In an exemplary
embodiment, the recessed region lacks a gripping surface.
In an exemplary embodiment, the first overmolded gripping region is formed by a
proximal terminal end of the housing having an exterior surface that is overmolded with a
gripping surface. In an exemplary embodiment, the second overmolded gripping region of the
housing has a tapered tubular structure.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the present invention will now be described, by way of
example only, with reference to the accompanying drawings wherein:
Figure 1 is a left side perspective view illustrating an exemplary automatic injection
device in which a removable distal cap is removed and pictured separately from the housing of
the device.
Figure 2 is a right side perspective view illustrating the exemplary automatic injection
device of Figure 1.
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Figure 3 is a left side exploded perspective view of the exemplary automatic injection
device of Figures 1 and 2.
Figure 4 is a front view of the exemplary automatic injection device of Figures 1-3.
Figure 5 is a left side view of the exemplary automatic injection device of Figures 1-3,
the right side view being a mirror image of the left side view.
Figure 6A is a front close-up view of an exemplary left gripping surface provided on a
first body portion of the device of Figures 1-3.
Figure 6B is a left side close-up view of the exemplary left gripping surface of Figure
Figure 7 is a bottom view of an exemplary removable distal cap of the exemplary
automatic injection device of Figures 1-3.
Figure 8 is a top view of an exemplary proximal terminal end of the exemplary
automatic injection device of Figures 1-3.
Figure 9 is a flowchart of an exemplary method for forming an exemplary automatic
injection device.
DESCRIPTION OF EMBODIMENTS
Exemplary embodiments provide automatic injection devices having housings that are
particularly designed and configured for reliable, safe, ergonomic and comfortable handling by
users. Exemplary embodiments also provide housing components for automatic injection
devices that are particularly designed and configured for reliable, safe, ergonomic and
comfortable handling by users. Exemplary embodiments also provide methods for fabricating
exemplary housings for automatic injection devices and automatic injection devices including
exemplary housings.
In one exemplary embodiment, one or more overmolded gripping surfaces may be
provided on an exterior surface of an exemplary automatic injection device housing in order to
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allow the device to be easily, comfortably and reliably gripped and manipulated by a user. The
exemplary overmolded gripping surfaces are particularly configured and positioned on the
housing to prevent slippage from the hands of the user, and thereby to avoid injury to the user
and others in the vicinity. Furthermore, the exemplary overmolded gripping surfaces are
particularly configured and positioned to be ergonomic and comfortable to use, particularly by
physically weak users, for example, older users, users who suffer from rheumatoid arthritis, and
the like.
In user tests performed using exemplary automatic injection devices, test participants
appreciated exemplary overmolded gripping surfaces on the sides of the devices and the
relatively large size and ergonomic shape of the device. The test participants provided high
ratings for handling and grip of exemplary devices, in which the overmolded gripping surfaces
were the primary factor in test participants’ high ratings of exemplary device configurations for
handling and grip, compared to devices without overmolded gripping surfaces. For several
usability factors, there was a significant positive correlation between Cochin scores and
exemplary device configurations, which indicates that exemplary devices are well-suited for use
by users with hand dysfunction.
An exemplary automatic injections device may contain and may be used to administer a
dose of a TNFα inhibitor. In an exemplary embodiment, the TNFα inhibitor may be a human
TNFα antibody or antigen-biding portion thereof. In an exemplary embodiment, the human
TNFα antibody or antigen-binding portion thereof may be adalimumab (HUMIRA®) or
golimumab.
I. Definitions
Certain terms are defined in this section to facilitate understanding of exemplary
embodiments.
The terms “automatic injection device” and “autoinjector,” as used herein, refer to a
device that enables a patient to self-administer a therapeutically effective dose of a therapeutic
agent, wherein the device differs from a conventional syringe by the inclusion of a mechanism
for automatically delivering the therapeutic agent to the patient by injection when the
mechanism is engaged.
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The terms “vessel” and “container,” as used herein, refer to a syringe or cartridge that
may be used in an exemplary automatic injection device for holding a dose of a therapeutic
agent.
The terms “syringe” and “cartridge,” as used herein, refer to a sterile barrel portion of
an automatic injection device that is filled with a dose of a therapeutic agent prior to distribution
or sale of the device to a patient or other non-medical professional for administration of the
therapeutic agent to a patient. In an exemplary embodiment, a distal end of the barrel portion of
a syringe may be coupled to a sterile hypodermic injection needle. In an exemplary
embodiment, a distal end of the barrel portion of a cartridge may not be coupled to an injection
needle. That is, in exemplary embodiments, a syringe may be a cartridge with a pre-attached
injection needle coupled to its barrel portion.
Exemplary embodiments described herein with reference to a syringe assembly may
also be implemented using a cartridge assembly. Similarly, exemplary embodiments described
herein with reference to a cartridge assembly may also be implemented using a syringe
assembly.
The term “pre-filled syringe,” as used herein, refers to a syringe that is filled with a
therapeutic agent immediately prior to administration of the therapeutic agent to a patient, and a
syringe that is filled with a therapeutic agent and stored in this pre-filled form for a period of
time before administration of the therapeutic agent to a patient.
The terms “injection needle” and “needle,” as used herein, refer to a needle in an
automatic injection device that is inserted into a patient’s body to deliver a dose of a therapeutic
agent into the patient’s body. In an exemplary embodiment, the injection needle may be directly
coupled to or may otherwise be in contact with a syringe assembly or a cartridge assembly that
holds a dose of the therapeutic agent. In another exemplary embodiment, the injection needle
may be indirectly coupled to the syringe or cartridge assembly, for example, via a syringe needle
and/or a transfer mechanism that provides fluid communication between the syringe or cartridge
assembly and the injection needle.
The term “pre-injection state,” as used herein, refers to a state of an automatic injection
device prior to activation of the device, i.e., prior to the start of delivery of a therapeutic agent
contained in the device.
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The term “injection state,” as used herein, refers to one or more states of an automatic
injection device during the delivery of a therapeutic agent contained in the device.
The term “post-injection state,” as used herein, refers to completion of delivery of a
therapeutically effective dose of a therapeutic agent contained in the device, or removal of the
device from the patient prior to completion of delivery of a therapeutically effective dose of the
therapeutic agent.
An automatic injection device provided in accordance with exemplary embodiments
may include a “therapeutically effective amount” or a “prophylactically effective amount” of an
antibody or antibody portion of the invention. A “therapeutically effective amount,” as used
herein, refers to an amount effective, at dosages and for periods of time necessary, to achieve the
desired therapeutic result. A therapeutically effective amount of the antibody, antibody portion,
or other TNFα inhibitor may vary according to factors such as the disease state, age, sex, and
weight of the patient, and the ability of the antibody, antibody portion, or other TNFα inhibitor
to elicit a desired response in the patient. A therapeutically effective amount is also one in which
any toxic or detrimental effects of the antibody, antibody portion, or other TNFα inhibitor are
outweighed by the therapeutically beneficial effects. A “prophylactically effective amount,” as
used herein, refers to an amount effective, at dosages and for periods of time necessary, to
achieve the desired prophylactic result. Typically, since a prophylactic dose is used in patients
prior to or at an earlier stage of disease, the prophylactically effective amount will be less than
the therapeutically effective amount.
The terms “substance” and “therapeutic agent,” as used herein, refer to any type of
drug, biologically active agent, biological substance, chemical substance or biochemical
substance that is capable of being administered in a therapeutically effective amount to a patient
employing exemplary automatic injection devices. Exemplary therapeutic agents usable in
exemplary automatic injection devices may include, but are not limited to, agents in a liquid
state. Such agents may include, but are not limited to, adalimumab (HUMIRA®) and proteins
that are in a liquid solution, e.g., fusion proteins and enzymes. Examples of proteins in solution
include, but are not limited to, Pulmozyme (Dornase alfa), Regranex (Becaplermin), Activase
(Alteplase), Aldurazyme (Laronidase), Amevive (Alefacept), Aranesp (Darbepoetin alfa),
Becaplermin Concentrate, Betaseron (Interferon beta-1b), BOTOX (Botulinum Toxin Type A),
Elitek (Rasburicase), Elspar (Asparaginase), Epogen (Epoetin alfa), Enbrel (Etanercept),
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Fabrazyme (Agalsidase beta), Infergen (Interferon alfacon-1), Intron A (Interferon alfa-2a),
Kineret (Anakinra), MYOBLOC (Botulinum Toxin Type B), Neulasta (Pegfilgrastim),
Neumega (Oprelvekin), Neupogen (Filgrastim), Ontak (Denileukin diftitox), PEGASYS
(Peginterferon alfa-2a), Proleukin (Aldesleukin), Pulmozyme (Dornase alfa), Rebif (Interferon
beta-1a), Regranex (Becaplermin), Retavase (Reteplase), Roferon-A (Interferon alfa-2), TNKase
(Tenecteplase), and Xigris (Drotrecogin alfa), Arcalyst (Rilonacept), NPlate (Romiplostim),
Mircera (methoxypolyethylene glycol-epoetin beta), Cinryze (C1 esterase inhibitor), Elaprase
(idursulfase), Myozyme (alglucosidase alfa), Orencia (abatacept), Naglazyme (galsulfase),
Kepivance (palifermin) and Actimmune (interferon gamma-1b).
The term “dose” or “dosage,” as used herein, refers to an amount of a therapeutic agent,
such as a TNFα inhibitor, which is administered to a patient preferably using the wearable
automatic injection device of the invention. In one embodiment, the dose comprises an effective
amount, for example, including, but not limited to, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg,
80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, and 160 mg, of the TNFα
inhibitor adalimumab.
The term “dosing,” as used herein, refers to the administration of a therapeutic agent
(e.g., an anti-TNFα antibody) to achieve a therapeutic objective (e.g., treatment of rheumatoid
arthritis).
The term “dosing regimen,” as used herein, refers to a treatment schedule for a
therapeutic agent, such as a TNFα inhibitor, e.g., a treatment schedule over a prolonged period
of time and/or throughout the course of treatment, e.g. administering a first dose of a TNFα
inhibitor at week 0 followed by a second dose of a TNFα inhibitor on a biweekly dosing
regimen.
The term “treatment,” as used herein, refers to therapeutic treatment, as well as
prophylactic or suppressive measures, for the treatment of a disorder, such as a disorder in
which TNFα is detrimental, e.g., rheumatoid arthritis.
The term “patient” or “user,” as used herein, refers to any type of animal, human or
non- human, that may be administered a therapeutic agent using exemplary automatic injection
devices.
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The term “proximal” refers to a portion or end or component of an exemplary
automatic injection device that is farthest from an injection site on a patient’s body when the
device is held against the patient for an injection or for mimicking an injection.
The term “distal” refers to a portion or end or component of an exemplary automatic
injection device that is closest to an injection site on a patient’s body when the device is held
against the patient for an injection or for mimicking an injection.
The term “planar” is used herein, in a broad lay sense, to mean exactly planar or
approximately planar within some tolerance from the exactly planar.
The term “concave” is used herein, in a broad lay sense, to mean exactly concave or
approximately concave within some tolerance from the exactly concave.
The term “convex” is used herein, in a broad lay sense, to mean exactly convex or
approximately convex within some tolerance from the exactly convex.
The term “elliptical” is used herein, in a broad lay sense, to mean exactly elliptical or
approximately elliptical within some tolerance from the exactly elliptical.
The term “oval” is used herein, in a broad lay sense, to mean exactly oval or
approximately oval within some tolerance from the exactly oval.
The term “rectangular” is used herein, in a broad lay sense, to mean exactly rectangular
or approximately rectangular within some tolerance from the exactly rectangular.
The term “parallel” is used herein, in a broad lay sense, to mean exactly parallel or
approximately parallel within some tolerance from the exactly parallel.
The term “straight” is used herein, in a broad lay sense, to mean exactly straight or
approximately straight within some tolerance from the exactly straight.
The term “equal” is used herein, in a broad lay sense, to mean exactly equal or
approximately equal within some tolerance.
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The term “adjacent” is used herein, in a broad lay sense, to mean immediately adjacent
or approximately adjacent within some tolerance.
The term “abut” is used herein, in a broad lay sense, to mean immediately abutting or
approximately abutting within some tolerance.
The term “transverse axis” is used herein to refer to an axis that is substantially
perpendicular to a longitudinal axis.
II. Exemplary Embodiments
Exemplary embodiments are described below with reference to certain illustrative
embodiments. While exemplary embodiments are described with respect to using an automatic
injection device to provide an injection of a dose of a therapeutic agent, one of ordinary skill in
the art will recognize that exemplary embodiments are not limited to the illustrative
embodiments and that exemplary automatic injection devices may be used to inject any suitable
therapeutic agent into a patient. In addition, components of exemplary automatic injection
devices and methods of making and using exemplary automatic injection devices are not limited
to the illustrative embodiments described below.
Figures 1-8 illustrate an exemplary automatic injection device 100 having one or more
overmolded gripping surfaces for facilitating gripping and manipulation of the device. The
figures indicate a longitudinal axis L that runs substantially along the length of the device 100, a
first transverse axis H that runs substantially perpendicular to the longitudinal axis L of the
device, and a second transverse axis V that runs substantially perpendicular to both longitudinal
axis L and first transverse axis H.
In some exemplary embodiments, an exemplary length of the device 100 may be about
4, 4.5, 4.8, 5, 5.5, 6, 6.5, 6.6, 6.7, 6.8, 6.9, 7, 7.5, 8, 8.5, 9, 9.5, 10 inches, but is not limited to
these exemplary lengths. In some exemplary embodiments, an exemplary width of the device
100 (at its widest location) may be about 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6,
1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0 inches, but is not limited to these
exemplary widths. In some exemplary embodiments, an exemplary thickness of the device 100
(at its thickest location) may be about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.11,
1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3,
14247789_1:hxa
2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0 inches, but is not limited to these exemplary thicknesses. In an
exemplary embodiment, the device 100 may have an exemplary length of about 6.69 inches, an
exemplary width of about 1.46 inches at the widest portion, and an exemplary thickness of about
1.15 inches at the thickest portion. In another exemplary embodiment, the device 100 may have
an exemplary length of about 4.8 inches, an exemplary width of about 0.8 inches at the widest
portion, and an exemplary thickness of about 0.6 inches at the thickest portion. The exemplary
dimensions of the recited exemplary devices allow the device to be conformably and
ergonomically held in the grip of a user’s hand. This allows a user to reliably and comfortably
grip and manipulate the device in order to perform an injection.
Exemplary automatic injection device 100 may include an outer housing 101 for
housing a container, such as a syringe or cartridge. The container may be pre-filled with a dose
of a therapeutic agent to be injected into a patient’s body. The housing 101 of the device, in its
assembled form, may have any suitable size and shape for storing and dispensing the dose of the
therapeutic agent. The assembled housing 101 may have a shape that is designed and configured
to be conformable to a user’s hand and so that the user can comfortably and reliably hold the
device 100 during an injection. In an exemplary embodiment, the assembled housing 101 may
have an elongated structure so that its length taken along the longitudinal axis L is much greater
than its width taken along the first transverse axis H and its thickness taken along a second
transverse axis V. An exemplary ratio of the length to the width (at the widest location) of the
device may be, but is not limited to, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, all intermediate
ratios, and the like. An exemplary ratio of the length to the thickness (at the thickest location) of
the device may be, but is not limited to, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, all
intermediate ratios, and the like.
Figure 1 is a left side perspective view illustrating an exemplary automatic injection
device 100 having an outer housing 101. Figure 2 is a right side perspective view of the
exemplary automatic injection device 100 of Figure 1. In an exemplary embodiment, the
housing 101 of the device 100 may have a tapered tubular structure with a substantially elliptical
or oval cross-section. In the tapered tubular structure, the width of the housing 101 may be
larger at a proximal portion 106 of the housing 101 than at a distal portion 104 of the housing
101. The tapered tubular shape of the exemplary housing allows the device to be streamlined
and to be conformably and ergonomically held in and manipulated by a user’s hand.
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The housing 101 of the device 100 may be formed of a plurality of body components
that are assembled together. In an exemplary embodiment, the housing 101 may be formed from
a first body portion 116 and a second body portion 118 that, when cooperatively engaged to
each other along their peripheral edges, enclose and provide a cavity therebetween. The first and
second body portions may be cooperatively engaged to each other using any suitable technique
including, but not limited to, bonding, gluing, ultrasonic welding, friction fit, snap fit,
interference fit, screws, attachment between corresponding protrusions and recesses, and the
like. One of ordinary skill in the art will recognize that, in other exemplary embodiments, the
cavity of the device may be enclosed in a single body component or in three or more body
components when assembled together.
A firing button 120 may extend from a surface of the first body portion 116. The firing
button 120, when activated by a user, may cause an injection to be performed by the device 100.
In an exemplary embodiment, a recessed or concave portion 126 may be provided on the first
body portion 116 abutting the firing button 120 to facilitate activation of the firing button 120.
The recessed portion 126 may surround the firing button 120 in an exemplary embodiment to
accommodate a user’s finger as the user presses on the firing button 120.
A transparent inspection window 128 may be provided in a surface of the first body
portion 116 to allow a user to view the contents of the device 100. The transparent inspection
window 128 may allow the user to view a therapeutic agent contained in the device 100, for
example, to ensure clarity of the agent, and to view an end-of-injection indicator that
materializes at the end of a successful injection. An exemplary inspection window 128 may be
substantially elongated in shape, for example, an elongated rectangle (with sharp or rounded
edges), an elongated elliptical shape, and the like, although other shapes are possible. In the
elongated inspection window 128, the length extending along the longitudinal axis L may be
substantially greater than the width extending along the first transverse axis H. In exemplary
embodiments, a ratio between the length and the width of the inspection window may include,
but is not limited to, 1.5:1, 2.0:1, 2.5:1, 3.0:1, 3.5:1, 4.0:1, 4.5:1, 5:1, all intermediate ratios, and
the like.
A proximal terminal end 172 of the device housing may be provided to cover the
proximal end of the device 100. In an exemplary embodiment, the proximal terminal end 172
may be coupled to the proximal end of the assembled first and second body portions. The
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proximal terminal end 172 may take any suitable size and shape. In an exemplary embodiment,
the proximal terminal end 172 may have a substantially tubular configuration with a
substantially oval or elliptical shape. In an exemplary embodiment, at least part of the exterior
surface of the proximal terminal end 172 may be overmolded with one or more gripping
surfaces 173 to facilitate gripping of the proximal portion of the device. In an exemplary
embodiment, the entire exterior surface of the proximal terminal end 172 may be covered by an
overmolded gripping surface 173. Corresponding recesses may be provided on the exterior
surface of the proximal terminal end 172 to accommodate the gripping surfaces.
A removable distal cap 164 may be coupled to the distal end of the assembled first and
second body portions to cover the distal end of the device 100 in order to prevent exposure of
the injection needle prior to an injection. The distal cap 164 protects against accidental and/or
unwanted contact of a user with the injection needle. The distal cap 164 also protects against
damage to and contamination of the injection needle when the device is not in use. The distal
cap 164 may take any suitable size and shape. In an exemplary embodiment, the distal cap 164
may have a substantially tubular configuration with a substantially oval or elliptical shape. In an
exemplary embodiment, a front surface of the distal cap 164 may have a concave cutout portion
168 for accommodating part of the inspection window 128.
In an exemplary embodiment, the exterior surface of the distal cap 164 may lack
overmolded gripping surfaces. In other exemplary embodiments, the exterior surface of the
distal cap 164 may be overmolded with one or more gripping surfaces 165 for facilitating
gripping and removal of the distal cap 164 from the device. In an exemplary embodiment, the
entire exterior surface of the distal cap 164 may be covered by an overmolded gripping surface
165. Corresponding recesses may be provided on the exterior surface of the distal cap 164 to
accommodate the gripping surfaces.
In an exemplary embodiment, one or more ridges (that protrude from the exterior
surface) and/or one or more grooves or divots (that are depressed into the exterior surface) may
be provided at the gripping surfaces 165 on the distal cap 164 to further facilitate gripping and
manipulation of the device. The shapes and locations of the ridges and/or grooves may be
altered as desired, and any desired number of ridges and/or grooves may be provided. In an
exemplary embodiment, the ridges and/or grooves may extend substantially perpendicularly to
the longitudinal axis L of the device. In an exemplary embodiment, the gripping surfaces 165
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may include textured surfaces to improve the tactile feel and further facilitate firm gripping of
the device. In an exemplary embodiment, the distal cap 164 may include one or more
protrusions 170a, 170b (shown in Figure 5) that extend outwardly from the front surface and the
back surface of the distal cap 164 to further facilitate gripping of the cap 164.
In an exemplary embodiment, the distal cap 164 may frictionally engage a recessed or
stepped portion of the housing in order to be retained in position on the housing when the device
is not in use. In an exemplary embodiment, the distal cap 164 may include a boss for locking
and/or joining the cap to the housing until the user is ready to perform an injection. Any suitable
mating mechanism may be used in accordance with the teachings of exemplary embodiments.
When the proximal terminal end 172, the first body portion 116 and the second body
portion 118 are assembled together, they form a tapered tubular structure. Side surfaces of the
body portions 116, 118 abutting the gripping surfaces 173 on the proximal terminal end 172
may include one or more recessed or concave portions 122, 124. In an exemplary embodiment,
two recessed portions 122, 124 may be provided at opposite sides of the device abutting the
firing button 120. The recessed portions allow the hand of the user to be accommodated in a
comfortable position when pressing the firing button 120.
A portion of the body portions 116, 118 abutting the recessed portions 122, 124 may be
overmolded with one or more gripping surfaces 154, 156 to facilitate holding and manipulation
of the device. In an exemplary embodiment, two gripping surfaces 154, 156 may be provided at
opposite side surfaces of the device. A first gripping surface 154 may abut a first recessed
portion 122, and a second gripping surfaces 156 may abut a second recessed portion 124.
Corresponding recesses may be provided on the exterior surface of the first body portion 116 to
accommodate the gripping surfaces.
In an exemplary housing for an automatic injection device, a first overmolded gripping
region, a second overmolded gripping region and a recessed region abutting the first and second
overmolded gripping regions may be provided. The first overmolded gripping region, the second
overmolded gripping region and the recessed region may cooperatively provide an ergonomic
and comfortable gripping area at which a user may grip the automatic injection device in order
to perform an injection.
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In this exemplary embodiment, the first overmolded gripping region may be formed by
the proximal terminal end 172 having an overmolded outer surface or covering. The second
overmolded gripping region may be formed part of the assembly of the first body portion 116
and the second body portion 118 having one or more overmolded gripping surfaces (for
example, gripping surfaces 154, 156). In an exemplary embodiment, the second overmolded
gripping region may have a substantially tapered tubular structure for providing an ergonomic fit
with a user’s hand. The recessed region abutting the first and second overmolded gripping
regions may be formed by a portion of the assembly of the first body portion 116 and the second
body portion 118 that is narrower in width than the first overmolded gripping region and the
second overmolded gripping region. In an exemplary embodiment, the recessed region may be
provided between the first and second overmolded gripping regions. In an exemplary
embodiment, the recessed region may lack any overmolded gripping surfaces.
Figure 3 illustrates an exploded view of the exemplary automatic injection device 100
of Figures 1 and 2. In an exemplary embodiment, the first body portion 116 may include a
substantially planar front surface (extending substantially along the L-H plane) and left and right
side surfaces (extending substantially along the L-V plane). The front surface of the first body
portion 116 may contiguously and integrally transition to left and right side surfaces of the first
body portion 116. The edges at which the front surface transitions to the side surfaces may be
sharp, or smooth and rounded in order to maintain a streamlined shape of the device and for
ergonomic handling of the device. The front and/or side surfaces of the first body portion 116
may be substantially flat or slightly convex so that the assembled housing ergonomically fits
within a user’s hand. The front surface may be wider at the proximal portion 106 of the device
than at the distal portion 104. One of ordinary skill in the art will recognize that other
exemplary shapes are possible for the first body portion 116 of the device.
In an exemplary embodiment, the second body portion 118 may include a substantially
planar front surface (extending substantially along the L-H plane) and left and right side
surfaces (extending substantially along the L-V plane). The front surface of the second body
portion 118 may contiguously and integrally transition to left and right side surfaces of the
second body portion 118. The edges at which the front surface transitions to the side surfaces
may be sharp, or smooth and rounded in order to maintain a streamlined shape of the device and
for ergonomic handling of the device. The front and/or side surfaces of the second body portion
118 may be substantially flat or slightly convex so that the assembled housing ergonomically
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fits within a user’s hand. The front surface may be wider at the proximal portion 106 of the
device than at the distal portion 104. One of ordinary skill in the art will recognize that other
exemplary shapes are possible for the second body portion 118 of the device.
As illustrated in Figure 3, the first body portion 116 and the second body portion 118
may be cooperatively engaged to each other along their peripheral edges to enclose and provide
a cavity 102 therebetween. The upper and second body portions may be cooperatively engaged
to each other using any suitable technique including, but not limited to, bonding, gluing,
ultrasonic welding, friction fit, snap fit, interference fit, screws, attachment between
corresponding protrusions and recesses, and the like. One of ordinary skill in the art will
recognize that, in other exemplary embodiments, the cavity 102 of the device may be enclosed
in a single body component or in three or more body components when assembled together.
An exemplary container 160 is preferably slidably positioned in the cavity 102 and is
coupled to an injection needle (not shown) at a distal end. The injection needle may be covered
by a needle shield 162, for example, a soft needle shield and/or a rigid needle shield. A
container advancement mechanism may be provided within the housing to mechanically
advance the container 160 within and relative to the housing and to eject the therapeutic agent
from the container 160 for performing an injection. The container advancement mechanism may
include one or more actuators (e.g., one or more biasing members) that move the container from
a sheathed position to a projecting position. When the device is in a pre-injection state, the
container 160 may be in a sheathed position, i.e., retracted within the housing. When the device
is actuated, the container advancement mechanism may advance the container 160 to a
projecting position so that the injection needle projects from a distal end of the housing to allow
ejection of the therapeutic agent into a patient’s body. The distal end of the housing may
include an aperture through which the needle may project.
The cavity 102 within the housing may also accommodate a firing engagement
mechanism, for example, the firing button 120. The firing button 120, when actuated by
depressing, activates the container advancement mechanism that, in turn, advances the container
160 toward the injection site, drives the injection needle into the injection site and delivers the
therapeutic agent into the injection site. In an exemplary embodiment, at least a portion of the
exterior surface of the firing button 120 may be overmolded with one or more rubberized
gripping surfaces to facilitate pressing of the firing button by a user’s finger or hand. In an
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exemplary embodiment, the entire exterior surface of the firing button may be covered by an
overmolded gripping surface. In an exemplary embodiment, the gripping surfaces on the firing
button 120 may be colored differently from the non-gripping surfaces to provide a visual
affordance to indicate which area of the device should be gripped. For example, the one or more
gripping surfaces on the firing button 120 may be green, while all other surfaces on the device
may be one or more colors that are not green.
Figure 3 shows that a front surface of the first body portion 116 may include a first
aperture 119 through which the firing button 120 may protrude outside the front surface. An
exemplary aperture 119 may be circular to accommodate the firing button 120 with a circular
cross-section, although other shapes are possible. The front surface of the first body portion 116
may include a second aperture 127 for accommodating the transparent inspection window 128.
As illustrated in Figure 3, in an exemplary embodiment, the removable distal cap 164
may frictionally engage a recessed or stepped portion 166 of the housing in order to be retained
in position on the housing when the device is not in use.
Figure 4 illustrates a front surface of the first body portion 116 of the exemplary
automatic injection device 100. Figure 5 illustrates a left side view of the first body portion 116
and the second body portion 118 as assembled in the device 100.
As illustrated in Figure 4, an exemplary automatic injection device 100 may have a
tapered tubular shape with a substantially elongated, elliptical cross-section. The proximal
terminal end 172 of the device may have a narrower proximal end (width w1) that broadens
slightly and gradually to a larger width (width w2) at the distal end of the proximal terminal end
172. The proximal end of the first body portion 116 abutting the proximal terminal end 172
may include one or more recessed portions 122, 124 at the sides. The recessed portions 122,
124 may create a narrow necked portion (width w3) that is narrower than the adjacent width
(width w2) of the proximal terminal end 172. At the distal end of the recessed portions 122,
124, the first body portion 116 may widen to the largest width of the device (width W) and may
gradually taper to a narrower width (width w4) near the mid-portion of the device. At the distal
portion 104 of the device, the first body portion 116 may have a substantially uniform narrow
width (width w4).
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The second body portion 118 may have a substantially similar shape and configuration
as the first body portion 116. As illustrated in Figure 5, in an exemplary embodiment, the
removable distal cap 164 may include one or more protrusions 170a, 170b (shown in Figure 5)
that extend outwardly from the front surface and the back surface of the distal cap 164 to further
facilitate gripping of the distal cap.
One of ordinary skill in the art will recognize that other shapes are possible in
exemplary automatic injection device 100.
As illustrated in Figures 4 and 5, in an exemplary embodiment, a left gripping surface
130 may be provided to partly cover and extend across the left side surface of the first body
portion 116, and a right gripping surface 132 may be provided to partly cover and extend across
the right side surface of the first body portion 116. In an exemplary embodiment, each gripping
surface 130, 132 may be disposed between the firing button 120 and the inspection window 128.
One of ordinary skill will recognize that other placements of the gripping surfaces 130, 132 are
possible. Similarly, in an exemplary embodiment, a left gripping surface 152 may be provided to
partly cover and extend across the left side surface of the second body portion 118, and a right
gripping surface 153 may be provided to partly cover and extend across the right side surface of
the second body portion 118. When the first and second body portions are assembled, the left
gripping surfaces 130, 152 may form a contiguous left gripping surface 154 on the housing, and
the right gripping surfaces 132, 153 may form a contiguous right gripping surface 156 on the
housing. The left and right contiguous gripping surfaces 154, 156 facilitate reliable and
comfortable gripping and manipulation of the device by a user’s hand, which markedly and
surprisingly improves the user experience of physically weak users, for example, older users and
users suffering from rheumatoid arthritis.
In user tests performed using exemplary automatic injection devices, test participants
liked the overmolded gripping surfaces on the sides of the device, the ridges on the overmolded
gripping surfaces, and the relatively large size and ergonomic shape of the device. Most test
participants (58%) strongly preferred the handling and grip of an example automatic injection
device of the present invention. Overall, the example device configuration received a high
average rating of 8.1 out of 10.0. The overmolded gripping surfaces were the primary factor in
the participants’ high ratings of the example device for handling and grip. For several usability
factors, there was a significant positive correlation between Cochin scores and the example
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device of the present invention with the overmolded gripping surfaces, which indicates that the
example device of the present invention is well-suited for those with hand dysfunction.
One of ordinary skill in the art will recognize that the left and right gripping surfaces
may have different sizes, shapes and configurations than the exemplary sizes, shapes and
configurations shown in Figures 1-8. One of ordinary skill in the art will recognize that more or
fewer gripping surfaces may be provided on exemplary automatic injection devices that the
exemplary left and right gripping surfaces shown in Figures 1-8. One of ordinary skill in the art
will also recognize that one or more gripping surfaces may be positioned on exemplary
automatic injection devices in positions other than the exemplary positions shown in Figures 1-
8. Further, one of ordinary skill in the art will recognize that the outline of each gripping surface
may have a smooth, rounded, streamlined configuration in some exemplary embodiments.
The overmolded gripping surfaces provided in exemplary embodiments may be formed
of any suitable material that provides a first soft and high-friction touch perception to a user, as
compared to the portions of the device that lack an overmolded gripping surface which provide a
second hard and low-friction touch perception to a user. The difference in the sensory
perceptions provides a touch affordance to a user, indicating that the device is to be gripped at
regions provided with the overmolded gripping surfaces.
In an exemplary embodiment, the overmolded gripping surfaces may be formed of a
first type of material having a soft, high-friction touch perception to a user, while the portions of
the device lacking overmolded gripping surfaces may be formed of a second type of material
having a harder, lower-friction touch perception to a user. In an exemplary embodiment, the
overmolded gripping surfaces may be formed of a first material with a lower hardness, while the
non-gripping surfaces may be formed of a second material with a higher hardness.
For example, the non-gripping surfaces may be formed of any rigid thermoplastic
material or rigid substrate suitable for use in a medical device application and suitable for
providing a hard, low-friction touch perception to the user. Rigid thermoplastics can include
materials such as polypropylene (PP), polyethylene (PE), polystyrene (PS), high impact
polystyrene (HIPS), polycarbonate (PC), acrynitrile-butadiene-styrene (ABS), poly(ethylene
terephthalate) (PET), polyamide (PA), PC/ABS blend and PPO/PS blends.
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Exemplary overmolded gripping surfaces may be formed of materials having any
suitable material grade and hardness for providing a soft, high-friction touch perception to the
user. Exemplary overmolded gripping surface materials may include, but are not limited to,
rubber (for example, having a durometer of 50A in one embodiment), thermoplastic elastomers
(TPEs), thermoplastic vulcanizate (TPV), and the like. Exemplary thermoplastic elastomers that
may be used to form exemplary overmolded gripping surfaces include, but are not limited to,
TPEs from KRAIBURG, the DynaflexTM TPE from PolyOne, the VersaflexTM TPE from
PolyOne, the VersollanTM TPE from PolyOne, the OnFlexTM TPE from Polyone, and the like.
Exemplary thermoplastic vulcanizates that may be used to form exemplary overmolded gripping
surfaces include, but are not limited to, the Santoprene™ thermoplastic from ExxonMobil and
the like.
In an exemplary embodiment, the overmolded gripping surfaces may be colored
differently from the non-gripping surfaces to provide a visual affordance to indicate which area
of the device should be gripped. For example, the left and right overmolded gripping surfaces
may be maroon in color while the non-gripping surfaces on the housing may be grey in color.
As illustrated in Figure 5, in an exemplary embodiment, one or more ridges (that
protrude from the exterior surface) and/or one or more grooves or divots (that are depressed into
the exterior surface) 158a, 158b, 158c (as illustrated in Figures 5 and 6B) may be provided at the
left overmolded gripping surface 154 and/or the right overmolded gripping surface 156 to
further facilitate gripping and manipulation of the device. The shapes and locations of the ridges
and/or grooves may be altered as desired, and any desired number of ridges and/or grooves may
be provided. In an exemplary embodiment, the ridges and/or grooves may extend substantially
perpendicularly to the longitudinal axis L of the device. In an exemplary embodiment, the
overmolded gripping surfaces may include textured surfaces to improve the tactile feel and
further facilitate firm gripping of the device.
Figure 6A is a front close-up view of an exemplary left overmolded gripping surface
130 provided on a first body portion 116 of the device 100 of Figure 1. Figure 6B is a left side
close- up view of the exemplary left overmolded gripping surface 130 of Figure 6A. The right
overmolded gripping surface 132 of the first body portion 116, the left overmolded gripping
surface 152 of the second body portion 118, and the right overmolded gripping surface 153 of
the second body portion 118 may be similar in structure and configuration.
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Referring to Figures 6A and 6B, the left overmolded gripping surface 130 may have a
first longitudinal side 134 that extends on the front surface of the first body portion 116
substantially along the longitudinal axis L. In an exemplary embodiment, the first longitudinal
side 134 of the left overmolded gripping surface 130 may be substantially linear, while in
another exemplary embodiment, the first longitudinal side 134 may be slightly concave or
convex. A proximal end 136 of the first longitudinal side 134 may extend toward and connect
with an end 138 of a first horizontal side 140 of the left overmolded gripping surface 130. The
first horizontal side 140 may extend across the left side surface of the first body portion 116
substantially along the second transverse axis V, ending at the peripheral edge of the first body
portion 116.
In an exemplary embodiment, a connecting side 142 extending between ends 136, 138
may connect the first longitudinal side 134 to the first horizontal side 140. In an exemplary
embodiment, the first horizontal side 140 may include a beveled edge extending to the first
longitudinal side 134 at an angle to both longitudinal axis L and the first transverse axis H.
In an exemplary embodiment, the first longitudinal side 134 of the left overmolded
gripping surface 130 may be substantially longer than the first horizontal side 140. An
exemplary ratio of the length of the first longitudinal side 134 to the length of the first horizontal
side 140 may include, but is not limited to, about 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, all
intermediate ratios, and the like.
A distal end 144 of the first longitudinal side 134 may extend toward and connect with
an end 146 of a second horizontal side 148 of the left overmolded gripping surface 130. In an
exemplary embodiment, a connecting side 150 extending between the ends 144, 146 may
connect the first longitudinal side 134 to the second horizontal side 148. In an exemplary
embodiment, the connecting side 150 may have a length greater than that of the connecting side
142. In exemplary embodiments, a ratio of the length of the connecting side 150 to the length of
the connecting side 142 may include, but is not limited to, 1.5:1, 1.75:1, 2:1, 2.25:1, 2.5:1,
2.75:1, 3:1, 3.25:1, 3.5:1, 3.75:1, 4:1, all intermediate ratios, and the like, but is not limited to
these exemplary ratios. The second horizontal side 148 may extend across the left side surface
of the first body portion 116 substantially along the second transverse axis V, ending at the
peripheral edge of the first body portion 116.
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In an exemplary embodiment, the first longitudinal side 134 may be substantially
longer than either the first horizontal side 140 or the second horizontal side 148. An exemplary
ratio of the length of the first longitudinal side 134 to the length of either horizontal side may
include, but is not limited to, about 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 5.5:1, 6:1, 6.5:1, 7:1, all
intermediate ratios, and the like.
Figure 7 is a bottom view of an exemplary removable distal cap 164 showing the
overmolded gripping surface 165. The overmolded gripping surfaces 165 may be formed of any
suitable material that provides first a soft and high-friction touch perception to a user, as
compared to the portions of the device that lack an overmolded gripping surface which provide a
hard and low-friction touch perception to a user. The difference in the sensory perceptions
provides a touch affordance to a user, indicating that the device is to be gripped at regions
provided with the overmolded gripping surfaces.
In an exemplary embodiment, the overmolded gripping surfaces may be formed of a
first type of material having a soft, high-friction touch perception, while the non-gripping
surfaces are formed of a second type of material having a harder, lower-friction touch
perception. Exemplary overmolded gripping surfaces 165 may be formed of materials having
any suitable material grade and hardness for providing a soft, high-friction touch perception to
the user. Exemplary overmolded gripping surface materials may include, but are not limited to,
rubber (for example, having a durometer of 50A in one embodiment), thermoplastic elastomers
(TPEs), thermoplastic vulcanizate (TPV), and the like. Exemplary thermoplastic elastomers that
may be used to form exemplary overmolded gripping surfaces include, but are not limited to,
TPEs from KRAIBURG, the DynaflexTM TPE from PolyOne, the VersaflexTM TPE from
PolyOne, the VersollanTM TPE from PolyOne, the OnFlexTM TPE from Polyone, and the like.
Exemplary thermoplastic vulcanizates that may be used to form exemplary overmolded gripping
surfaces include, but are not limited to, the Santoprene™ thermoplastic from ExxonMobil and
the like. In an exemplary embodiment, the overmolded gripping surfaces 165 may be colored
differently from the non-gripping surfaces to provide a visual affordance to indicate which area
of the device should be gripped. For example, the one or more overmolded gripping surfaces
165 on the distal cap 164 may be maroon in color while the non-gripping surfaces on the
housing may be grey in color.
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Figure 8 is a top view of an exemplary proximal terminal end 172 for covering the
proximal end of the housing. In an exemplary embodiment, the exterior surface of the proximal
terminal end 172 may lack any overmolded gripping surfaces. In other exemplary embodiments,
at least part of the exterior surface of the proximal terminal end 172 may be overmolded with
one or more gripping surfaces 173 to facilitate gripping of the proximal portion of the device. In
an exemplary embodiment, the entire exterior surface of the proximal terminal end 172 may be
covered by an overmolded gripping surface 173.
The overmolded gripping surfaces 173 may be formed of any suitable material that
provides a first soft and high-friction touch perception to a user, as compared to the portions of
the device that lack an overmolded gripping surface which provide a second soft and low-
friction touch perception to a user. The difference in the sensory perceptions provides a touch
affordance to a user, indicating that the device is to be gripped at regions provided with the
overmolded gripping surfaces.
In an exemplary embodiment, the overmolded gripping surfaces 173 may be formed of
a first type of material having a soft, high-friction touch perception, while the non-gripping
surfaces are formed of a second type of material having a harder, lower-friction touch
perception. Exemplary overmolded gripping surfaces 173 may be formed of materials having
any suitable material grade and hardness for providing a soft, high-friction touch perception to
the user. Exemplary overmolded gripping surface materials may include, but are not limited to,
rubber (for example, having a durometer of 50A in one embodiment), thermoplastic elastomers
(TPEs), thermoplastic vulcanizate (TPV), and the like. Exemplary thermoplastic elastomers that
may be used to form exemplary overmolded gripping surfaces include, but are not limited to,
TPEs from KRAIBURG, the DynaflexTM TPE from PolyOne, the VersaflexTM TPE from
PolyOne, the VersollanTM TPE from PolyOne, the OnFlexTM TPE from Polyone, and the like.
Exemplary thermoplastic vulcanizates that may be used to form exemplary overmolded
gripping surfaces include, but are not limited to, the Santoprene™ thermoplastic from
ExxonMobil and the like. In an exemplary embodiment, the overmolded gripping surfaces 173
may be colored differently from the non-gripping surfaces to provide a visual affordance to
indicate which area of the device should be gripped. For example, the one or more overmolded
gripping surfaces 173 on the proximal terminal end 172 may be maroon in color while the non-
gripping surfaces on the housing may be grey in color.
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In an exemplary embodiment, one or more ridges (that protrude from the exterior
surface) and/or one or more grooves or divots (that are depressed into the exterior surface) may
be provided on the exterior surface of the proximal terminal end 172 to further facilitate
gripping of the proximal portion of the device. The shapes and locations of the ridges and/or
grooves may be altered as desired, and any desired number of ridges and/or grooves may be
provided. In an exemplary embodiment, the overmolded gripping surfaces 173 may include
textured surfaces to improve the tactile feel and further facilitate firm gripping of the device. In
an exemplary embodiment, a wrap-around groove 174 may be provided around the
circumference of the proximal terminal end 172 and a concave or recessed surface 176 may be
provided at the top of the proximal terminal end 172 in order to orient and guide a user’s hand
and fingers to the device. For example, the concave or recessed surface 176 may accommodate a
finger on the surface 176 while the user is performing an injection using the device.
In some exemplary embodiments, the housing 101, the removable distal cap 164 and/or
the proximal terminal end 172 of the device 100 may further include graphics, symbols and/or
numbers to facilitate use of the automatic injection device. For example, the distal cap 164 may
include a depiction of an arrow on an outer surface pointing towards the distal end of the device
to indicate how the device should be held relative to the patient (i.e., with the distal end adjacent
to the injection site). One of ordinary skill in the art will recognize that the automatic injection
device may have any suitable graphics, symbols and/or numbers to facilitate patient instruction,
or the automatic injection device may omit such graphics, symbols and/or numbers.
Figure 9 is a flowchart of an exemplary method of assembling an exemplary automatic
injection device. In an exemplary embodiment, a housing of an exemplary automatic injection
device may be provided in two or more separate housing components (for example, first and
second body portion) that may be coupled together during assembly of the device.
In step 902, a first body portion of the housing is provided or formed. In step 904, one
or more gripping surfaces are overmolded on corresponding recesses on the exterior surface of
the first body portion to facilitate gripping and manipulation of the device during an injection.
In step 906, a second body portion of the housing is provided or formed. In step 908,
one or more gripping surfaces are overmolded on corresponding recesses on the exterior surface
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of the second body portion to facilitate gripping and manipulation of the device during an
injection.
In step 910, a proximal terminal end of the housing is provided or formed. In step 912,
one or more gripping surfaces are overmolded on corresponding recesses on the exterior surface
of the proximal terminal end to facilitate gripping and manipulation of the device.
In step 914, a removable distal cap of the housing is provided or formed. In step 916,
one or more gripping surfaces are overmolded on corresponding recesses on the exterior surface
of the distal cap to facilitate removal of the distal cap before performing an injection.
In step 918, a firing button of the housing is provided or formed. In step 920, one or
more gripping surfaces are overmolded on the exterior surface of the firing button to facilitate
activation of the firing button to perform an injection.
In step 922, one or more internal components of the automatic injection device may be
positioned in a cavity defined between the upper and second body portions. Exemplary device
components may include, but are not limited to, a container (e.g., a syringe) pre-filled with a
therapeutic agent for injecting into a patient, an injection needle coupled to a distal end of the
container, a container advancement mechanism for advancing the container within and relative
to the housing toward the injection site and for ejecting the therapeutic agent from the container
during an injection, a firing button for activating the container advancement mechanism, and the
like.
In step 924, the upper and second body portions may be cooperatively engaged to form
a body assembly that encloses and holds the internal components within the cavity. In an
exemplary embodiment, the body portions may be coupled at their peripheral edges. Any
suitable coupling or joining may be used in step 924 including, but not limited to, bonding,
gluing, ultrasonic welding, friction fit, snap fit, interference fit, screws, corresponding
protrusions and recesses, and the like.
In step 926, the removable distal cap may be removably coupled at a distal end of the
body assembly to cover an injection needle or a needle shield that, in turn, covers the injection
needle.
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In step 928, the proximal terminal end may be coupled at a proximal end of the body
assembly.
Any suitable fabrication technique may be used to form any of the device components
including, but not limited to, injection molding. The device components may be formed of any
suitable material including, but not limited to, plastics, thermoplastics, polycarbonates, metals,
and the like.
It is noted that the order of the steps discussed herein may be altered as desired and that
other fabrication steps/techniques are possible and are considered within the spirit and scope of
the present invention.
Automatic Injection Device User Tests
Forty-four test participants were recruited to test both the exemplary automatic
injection devices having overmolded gripping surfaces of the present invention and four
alternate automatic injection devices without such gripping surfaces. A majority of the
participants were suffering from rheumatoid arthritis (RA) at the time of the test. The
participants were diagnosed with RA from 1 to 40 years ago, with an average age of diagnosis
of 9 years ago. Four participants were suffering from Crohn’s disease at the time of the test.
Test Procedure
Each test participant tested the different exemplary automatic injection device
configurations. In particular, in an example device use phase, each test participant performed a
simulated injection (i.e., an injection with clipped needles and no medicament) using the
devices. After he/she performed a simulated injection, each test participant was asked a series of
follow- up questions designed to assess the participant’s approval of the form and function of
the devices. These questions included questions on, for example, the size, shape, ease of
handling, comfort of holding, overall user experience, and the like.
Device Handling and Gripping
Upon performing simulated injections using the different device configurations, test
participants were asked to provide feedback and comparative ratings on handling and grip,
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overall ease of use, and comfort in performing the injection steps. All device configurations
were rated on a scale of 1 (very negative) to 10 (very positive).
Most test participants (58%) strongly preferred the handling and grip of the example
device configuration of the present invention, compared to four alternate device configurations
that did not include overmolded gripping surfaces. Test participants particularly liked the
rubberized overmolded grips on the side of the example device and its relatively large size,
which made the example device easy and comfortable to hold. The rubberized overmolded grips
were the primary factor in participants’ high ratings of the example device configuration for
handling and grip as taught herein.
Furthermore, a correlation analysis was performed on hand dysfunction using the
Cochin hand disability scale with the ratings provided for certain usability factors: handling and
gripping, ease of use, ease of starting and performing an injection, comfort of performing
injection, acceptability and overall preference. For several usability factors, there was a
significant positive correlation between Cochin scores and the example device configuration of
the present invention, which indicates that this example device configuration is well-suited for
those with hand dysfunction.
Comfort of Device Holding and Use
Upon performing simulated injections in the example device use phase, test participants
were asked to rate the comfort of holding the example device configuration of the present
invention and four alternate device configurations that did not include any overmolded gripping
surfaces. Test participants rated each device configuration on a scale from 1 (very low
confidence) to 7 (very high confidence). Most test participants favored the example device
configuration of the present invention for comfort in performing injection steps, with 45% rating
it the highest.
Ease of Device Use And Handling
Upon initial exposure to the example device and before receiving instructions or a
demonstration on use, test participants were asked about the perceived ease of use of the
example device configuration of the present invention and four alternate device configurations
that did not include any overmolded gripping surfaces. Test participants rated each device
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configuration on a scale from 1 (very difficult) to 7 (very easy). All of the device configurations
received high ratings for their perceived ease of use.
Upon performing simulated injections in the actual device use phase, test participants
were asked to rate the ease of handling each device configuration. Test participants rated each
device configuration on a scale from 1 (very low confidence) to 7 (very high confidence).
Furthermore, upon performing simulated injections using the device configuration in the third
actual device use phase, test participants were also asked to rate the configurations on their
overall ease of use on a scale of 1 (very difficult) to 10 (very easy).
Most test participants (42%) found the example device configuration of the present
invention easiest to use compared to four alternate device configurations that did not include
overmolded gripping surfaces. Overall, the example device configuration of the present
invention received a high average rating of 7.97 out of 10.0.
Device Size
Upon performing simulated injections in the example device use phase, test participants
were asked to rate the overall size of the example device configuration of the present invention
and four alternate device configurations that did not include any overmolded gripping surfaces
on a scale of 1 (very low confidence) to 7 (very high confidence). All of the device
configurations generally received positive ratings for their overall shape. In general, test
participants who struggled to form a tight fist preferred larger devices. The example device
configuration of the present invention generally received the highest ratings.
Device Shape
Upon performing simulated injections in the actual device use phase, test participants
were asked to rate the overall shape of the example device configuration of the present invention
and four alternate device configurations that did not include any overmolded gripping surfaces
on a scale of 1 (very low confidence) to 7 (very high confidence).
All of the device configurations generally received positive ratings for their overall
size. In general, test participants who struggled to form a tight fist preferred larger devices. With
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respect to the example device configuration of the present invention, many participants found
that the shape fit nicely in their hand.
III. Incorporation by Reference
The contents of all references, including patents and patent applications, cited
throughout this application are hereby incorporated herein by reference in their entirety. The
appropriate components and methods of those references may be selected for the invention and
embodiments thereof. Still further, the components and methods identified in the Background
section are integral to this disclosure and can be used in conjunction with or substituted for
components and methods described elsewhere in the disclosure within the scope of the
invention.
IV. Equivalents
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 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, 1/5th, 1/3rd, 1/2nd, 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.
Exemplary flowcharts are provided herein for illustrative purposes and are non-limiting
examples of methods. One of ordinary skill in the art will recognize that exemplary methods
may include more or fewer steps than those illustrated in the exemplary flowcharts, and that the
steps in the exemplary flowcharts may be performed in a different order than shown.
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Claims (8)
1. An injection device, comprising: a first body portion; a second body portion cooperatively engageable to the first body portion to form a gripping region of the device at a proximal portion thereof and to define an injection region of the device at a distal portion thereof; a first overmolded gripping surface disposed along a first side of the gripping region; a second overmolded gripping surface disposed along a second side of the gripping region opposite the first overmolded gripping surface; a first recessed portion abutting the first overmolded gripping surface; a second recessed portion abutting the second overmolded gripping surface; a firing button that extends from a recessed surface of the first body portion; an inspection window disposed in the injection region to allow a user to view a content of a container disposed within the injection device; a removable cap couplable to the distal portion of the device, the removable cap having a concave cutout portion for accommodating part of the inspection window; and a third overmolded gripping surface disposed over an exterior surface of the removable cap.
2. The injection device of claim 1, further comprising one or more grooves or divots depressed into the first overmolded gripping surface and the second overmolded gripping surface.
3. The injection device of claim 1, further comprising one or more protrusions extending outwardly from a front surface and a back surface of the removable cap.
4. The injection device of claim 1, wherein the gripping region has a tapered structure.
5. The injection device of claim 1, wherein a front surface of the first body portion is flat.
6. The injection device of claim 5, wherein a front surface of the second body portion is flat. 22858461_1
7. The injection device of claim 6, wherein side surfaces of the first body portion are convex.
8. The injection device of claim 7, wherein side surfaces of the second body portion are convex. AbbVie Biotechnology Ltd. By the Attorneys for the Applicant SPRUSON & FERGUSON Per: 22858461_1 REPLACEMENT SHEET Proximal Portion 106 Distal Portion 104 124 100
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161435465P | 2011-01-24 | 2011-01-24 | |
US61/435,465 | 2011-01-24 | ||
NZ722287A NZ722287B2 (en) | 2011-01-24 | 2012-01-24 | Automatic injection devices having overmolded gripping surfaces |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ739694A NZ739694A (en) | 2019-08-30 |
NZ739694B2 true NZ739694B2 (en) | 2019-12-03 |
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