Automatic injection devices having overmolded gripping surfaces.

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Mexican Property

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PATENT TITLE NO. 337208

Owner (s): ABBVIE BIOTECHNOLOGY LTD.

Address: Clarendon House, 2 Church Street, Hamilton, HM 11, BERMUDA

Designation: AUTOMATIC INJECTION DEVICES HAVING OVERMOLDED GRIPPING SURFACES ¿U:. .

Classification: lnt.CI.8: A61B5 / 15; A61M5 / 31

Inventor (s): JOSEPH F. JULIAN; CHUAN Ll; AARON B. EIGER; MARK KURTH; SABRINA

KATZ; ADAM CALIF; JAMES C. STANGO

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V goncia: Twenty

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The reference attempt is

Ddponfbnmidad with the artfct copied from the chos

Qi | fen susente the present Industrial Priority (Daily

11/2004, 06/16/2005, fl / 25/2006, 0 * 5 / 2009,06 / 01/2010, 18 ίηφο a), 4th and 12th fraction i and III of the Regulations of the Mexican Institute &lt;&gt; / 2004 and I ey of '05 / 1999, industrial.

printable, v before the and 7th bis 2 of the 0/1996, 12/25/1997, 1 '04 / 2012); Articles 1, 3, action V Industrial (DOF 12/14/1999.

Organic of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1st, 3rd and 5th Clause a) of the Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisional Directors, Heads of Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

Issue Date: February 17, 2016

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Mxfal 2013) 0086 Η

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AUTOMATIC INJECTION DEVICES

GRIPPING SURFACES SQBREMQLDEXIO ^ .fgg

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RATED REQUESTS

This application is a non-provisional application and claims priority from US Provisional Patent Application No. 61 / 435,465, filed January 24, 2011, the entire contents of which are expressly incorporated herein by reference in its entirety. .

BACKGROUND

Automatic injection devices offer an alternative to manually operated syringes for delivering therapeutic agents into the body of patients, and allow patients to self-administer therapeutic agents. Automatic injection devices can 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 the administration of antiarrhythmic drugs and selective thrombolytic agents during a heart attack; see, for example, US Patent Nos. 3,910,260; 4,004,577; 4,689,042; 4,755,169; and 4,795,433; the entire content of which is incorporated herein in its entirety by reference. Various types of injection devices

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Automatic machines are also described, for example, in the patents of E

US 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 in International Patent Publication No. WO / 2008/005315, the full content of which is incorporated herein in its entirety by reference.

Conventionally, an automatic injection device houses a syringe and, when operated, causes the syringe to move forward and a needle to project from the housing, such that a therapeutic agent contained in the syringe is propelled into the body of the syringe. a patient.

BRIEF DESCRIPTION OF THE INVENTION

Exemplary embodiments provide automatic injection devices, housing components for automatic injection devices, and methods for manufacturing them. An exemplary housing of an automatic injection device may be overmolded with one or more gripping surfaces to facilitate grasping and manipulation of the automatic injection device by a user when performing an injection. In an exemplary embodiment, a left overmolded grip surface may extend along a left side of the housing, and a right overmolded grip surface may extend along a right side of the housing opposite the left side.

In accordance with an exemplary embodiment, a

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Automatic injection s provides a housing that encloses a cavity to accommodate a container. A first overmolded gripping surface extending longitudinally along a portion of the housing is provided on a first external surface of the housing. A second overmolded gripping surface extending longitudinally along a portion of the housing is provided on a second outer surface of the housing opposite the first outer surface.

In an exemplary embodiment, the first and second overmolded gripping surfaces of the housing are formed of a first material having a first feel feel, and the non-gripping surfaces of the housing are formed of a second material having a second feel. touch. In an exemplary embodiment, the first and second overmolded gripping surfaces of the housing are formed of a first material having a first hardness, and the non-gripping surfaces of the housing are formed of a second material having a second higher hardness. .

In an exemplary embodiment, the automated Injection device includes a removable distal cap to protectively cover an injection needle engageable with the container; an outer surface of the distal cap including an overmolded gripping surface to facilitate gripping and removal of the distal cap. In an exemplary embodiment, the Automatic Injection device includes a fire button that protrudes from an opening in the housing, and includes an overmolded contact surface to facilitate removal.

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actuation of the fire button by a user. In an exemplary embodiment, the automatic injection device includes a proximal end end to cover a proximal end of the automatic injection device, the proximal end end having an external overmolded surface. In an exemplary embodiment, an upper surface of the proximal end end includes a recessed surface to direct and facilitate accommodation of a user's hand or fingers to grasp the automatic injection device.

According to another exemplary embodiment, a method is provided for assembling an automatic injection device. The method includes providing a housing that encloses a cavity to accommodate a container. The method includes overmolding, onto the housing, a first gripping surface that extends longitudinally along a portion of the housing onto a first external surface of the housing. The method also includes overmolding, onto the housing, a second gripping surface that extends longitudinally along a portion of the housing onto a second outer surface of the housing opposite the first outer surface.

In an exemplary embodiment, the first and second gripping surfaces of the housing are formed of a first material having a first feel feel, and the non-gripping surfaces of the housing are formed of a second material having a second feel to the touch. touch. In an exemplary embodiment, the first and second gripping surfaces of the housing are formed of a first material that

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has a first hardness, and the non-gripping surfaces of the housing are formed of a second material that has a second, higher hardness.

In an exemplary embodiment, the method includes overmolding a gripping surface onto an external surface of a distal cap to facilitate gripping and detaching of the distal cap, and engaging the distal cap with a distal end of the housing to protectively cover a needle. injection. In an exemplary embodiment, the method includes overmolding a grip surface over a fire button to facilitate activation of the fire button, and providing the fire button within the cavity so that a portion of the fire button protrudes from an opening. in the accommodation.

In an exemplary embodiment, the method includes overmolding a gripping surface onto an outer surface of a proximal terminal end, and mating the proximal terminal end with a proximal end of the housing. In an exemplary embodiment, an upper surface of the proximal end end includes a recessed surface for directing a user's hand or fingers to grasp the Automatic Injection device.

In accordance with another exemplary embodiment, an automatic injection device is provided that includes a housing that encloses a cavity to accommodate a container. The housing includes a first overmolded grip region, a second overmolded grip region, and a recessed region abutting the first and second overmolded grip regions.

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In an exemplary embodiment, the recessed region is disposed between the first and second overmolded grip regions. In an exemplary embodiment, the width of the housing in the recessed region is less than the width of the housing in the first overmolded grip region and the width of the housing in the second overmolded grip 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 end end of the housing having an outer 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

The foregoing objects, aspects, characteristics and advantages and other exemplary modalities will become more evident and will be better understood with reference to the following description, taken in conjunction with the attached drawings, in which:

FIG. 1 is a left side perspective view illustrating an exemplary automatic injection device in which a removable end cap is detached and depicted separately from the device housing.

Figure 2 is a right side perspective view illustrating

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the j mplar automatic injection device of figure 1.

Figure 3 is a schematic left-side 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 close-up front view of an exemplary left grip surface provided on a first body portion of the device of Figures 1-3.

FIG. 6B is a close-up view of the left side of the exemplary left gripping surface of FIG. 6A.

Figure 7 is a bottom view of an exemplary removable end cap of the exemplary automatic injection device of the figures.

1-3.

Figure 8 is a top view of an exemplary proximal end end of the exemplary automatic injection device of the figures.

1-3.

Figure 9 is a flow chart of an exemplary method of forming an exemplary automatic injection device.

DETAILED DESCRIPTION

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OF INDUSTRIAL PROPERTY

Exemplary embodiments provide automatic injection devices having housings that are particularly designed and configured to be reliably, safely, ergonomically and comfortably operated by users. Exemplary embodiments also provide housing components for automatic injection devices that are particularly designed and configured to be reliably, safely, ergonomically and comfortably handled by users. The exemplary embodiments also provide methods for manufacturing the exemplary housings for automatic injection devices, and automatic injection devices that include the exemplary housings.

In an exemplary embodiment, one or more overmolded gripping surfaces may be provided on an external surface of an exemplary automatic injection device housing, to allow the device to be easily, comfortably and reliably grasped and manipulated by a user. Exemplary overmolded gripping surfaces are particularly configured and positioned on the housing to prevent slipping of the user's hands, and thus avoid injury to the user and others around. Furthermore, exemplary overmolded gripping surfaces are particularly configured and positioned to be ergonomic and comfortable for use, particularly by physically infirm users, eg, older users, users who

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suffer from rheumatoid arthritis, etc. ^instof the property

In user tests performed using the exemplary automatic injection devices, test participants appreciated the exemplary overmolded gripping surfaces on the sides of the devices and the relatively large size and ergonomic shape of the device. Test participants gave high handling and grip scores of exemplary devices, with overmolded grip surfaces being the main factor in test participants' high scores of 10 exemplary device configurations for handling and grip, compared to devices without overmolded gripping surfaces. For various wearing factors there was a significant positive correlation between the Cochin scores and the exemplary device configurations, indicating that the exemplary devices are very suitable for use by users with hand dysfunction.

An exemplary automatic injection device can contain a dose of a TNFa inhibitor, and can be used to administer it. In an exemplary embodiment, the TNFa inhibitor may be an antibody to human TNFa or antigen-binding portion thereof. In an exemplary embodiment, the antibody to human TNFa or antigen-binding portion thereof can be adalimumab (HUMIRA®) or golimumab.

I. Definitions

Some terms are defined in this section to facilitate the

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understanding of exemplary modalities. Industrial - The terms "nyecetén-aulumátruu device and" autoinjector, "as used herein, refer to a device that allows a patient to self-administer a therapeutically effective dose of a therapeutic agent, wherein the device differs of a conventional syringe by the inclusion of a mechanism to automatically deliver the therapeutic agent to the patient by injection when the mechanism is engaged.

The terms "container and" package, as used herein, refer to a syringe or cartridge that can be used in an exemplary automatic injection device to retain 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 the administration of the therapeutic agent to a patient. In an exemplary embodiment, a distal end of the barrel portion of a syringe can be coupled with a sterile hypodermic injection needle. In an exemplary embodiment, a distal end of the barrel portion of a cartridge may not engage an injection needle. That is, in exemplary embodiments, a syringe can be a cartridge with a pre-attached injection needle engaged with its barrel portion.

Exemplary modalities described in

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this for a syringe assembly using a cartridge assembly. Similarly, exemplary embodiments described herein with respect to a cartridge assembly can also be practiced using a syringe assembly.

The term "prefilled 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 is stored in this prefilled form for a period prior to 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 the body of a patient to deliver a dose of a therapeutic agent into the body. of the patient. In an exemplary embodiment, the injection needle can be directly coupled, or otherwise contacted, with a syringe assembly or a cartridge assembly that retains 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 by means of a syringe needle and / or a transfer mechanism that provides fluid communication between the syringe or cartridge assembly and injection needle.

The term "pre-injection state", as used herein, refers to a state of an automatic injection device prior to device activation, that is, prior to initiation of delivery.

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of a therapeutic agent contained in the device.

The term "injection state", as used herein, refers to one or more states of an automatic injection device during delivery of a therapeutic agent contained in the device.

The term "post-injection state", as used herein, refers to the termination 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 termination of delivery of a therapeutically effective dose of the therapeutic agent.

An automated injection device provided according to 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 effective amount, at the doses and for the times necessary, to achieve the desired therapeutic result. A therapeutically effective amount of the antibody, antibody portion, or other TNFa inhibitor may vary according to factors such as the disease state, the age, sex, and weight of the patient, and the capacity of the antibody, antibody portion, or other inhibitor. of TNFa to elicit a desired response in the patient. A therapeutically effective amount is also one in which any toxic or deleterious effects of the antibody, antibody portion or other TNFα inhibitor are outweighed by the therapeutically beneficial effects. An “amount prophylactically

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INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL effective ”, as used herein, refers to an effective amount, at the doses and for the times necessary, to achieve the desired prophylactic result. Typically, since the prophylactic dose is used in patients before the onset of the disease, or at an early stage of the 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, which is capable of being administered in a therapeutically effective amount. to a patient using exemplary automatic injection devices. Exemplary therapeutic agents usable in exemplary automated injection devices may include, without limitation, agents in a liquid state. These agents can include, without limitation, adalimumab (HUMIRA®) and proteins that are in a liquid solution, for example fusion proteins and enzymes. Examples of proteins in solution include, without limitation, 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), Fabrazyme (agalsidase beta), Infergen (interferon alfacon-1), Intron A (interferon alpha-2a), Kineret (anakinra), MYOBLOC (botulinum toxin type B), Neulasta (pegfilgrastim), Neumega

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MEXICAN INSTITUTE

FROM THE LTsk-Z PROPERTY!

INDUSTRIAL (oprelvekin), Neupogen (filgrastim), Ontak (denileukin diftitox), PEGASYS (peginterferon alfa-2a), Proleukin (aldesleukin), Pulmozyme (dornase alfa), Rebif (interferon beta-1a), Regranex (becaplevase) (reteplase), Roferon-A (interferon alfa-2), TNKase (tenecteplase), and Xigris (Drotrecogin alfa), Arcalyst (rilonacept), NPIate (romiplostim), Mircera (methoxypolyethylene glycol-epoetin beta), Cinryze (esterase inhibitor) C1), Elaprase (idursulfase), Myozyme (alglucosidase alfa), Orencia (abatacept), Naglazyme (galsuifase), Kepivance (palifermin), and Actimmune (gamma-1b interferon).

The term "dose, as used herein, refers to an amount of a therapeutic agent, such as a TNFa inhibitor, that is administered to a patient preferably using the usable automatic injection device of the invention. In one embodiment, the dose comprises an effective amount including, for example, without limitation, 20mg, 30mg, 40mg, 50mg, 60mg, 70mg, 80mg, 90mg, 100mg, 110mg, 120mg , 130 mg, 140 mg, 150 mg, and 160 mg, of the TNFa inhibitor adalimumab.

The term "dosage", as used herein, refers to the administration of a therapeutic agent (eg, an anti-TNFa antibody) to achieve a therapeutic goal (eg, the treatment of rheumatoid arthritis).

The term "dosage regimen", as used herein, refers to a program of treatment with a therapeutic agent, such as a TNFa inhibitor, for example a program of treatment over a prolonged period and / or throughout the course d

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INSTITUTO MEXICANO DE LA PROPERTY treatment, for example administering a first fldW '¹ of ^ -or TNFa inhibitor at week 0, followed by one-fifth dose of a TNFa inhibitor on a biweekly dosing regimen.

The term "treatment", as used herein, refers to a therapeutic treatment and also to prophylactic or suppressive measures for the treatment of a disorder, such as a disorder in which TNFa is deleterious, for example, rheumatoid arthritis.

The term "patient or" user, "as used herein, refers to any type of animal, human or non-human, to which a therapeutic agent can be administered using exemplary automatic injection devices.

The term "proximal" refers to a portion, or end, or component of an exemplary automatic injection device, that is farthest from an injection site in the body of a patient when the device is held against the patient for an injection. or to mimic 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 in a patient's body when the device is held against the patient for an injection. or to mimic an injection.

The term "flat", as used herein, in a broad sense, means exactly flat or approximately flat within some tolerance from exactly flat.

The term "concave" as used herein in a sense

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INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL broad, means exactly concave or approximately concave within some tolerance from exactly concave.

The term "convex, as used herein in a broad sense, means exactly convex or approximately convex within some tolerance from exactly convex.

The term "elliptical", as used in a broad sense herein, means exactly elliptical or roughly elliptical within some tolerance from exactly elliptical.

The term "oval", as used in a broad sense herein, means exactly oval or approximately oval within some tolerance from exactly oval.

The term "rectangular" as used in a broad sense herein, means exactly rectangular or approximately rectangular within some tolerance of exactly rectangular.

The term "parallel", as used in a broad sense herein, means exactly parallel or approximately parallel within some tolerance from exactly parallel.

The term "straight" as used in a broad sense herein, means exactly straight or approximately straight within some tolerance from exactly straight.

The term "Equal", as used in a broad sense herein, means exactly the same or approximately the same within some tolerance.

The term "adjacent", as used herein in a broad sense, means immediately adjacent or approximately

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adjacent within some tolerance.

The term "abutting", as used in a broad sense herein, means immediately abutting or approximately abutting within some tolerance.

The term "transverse axis", as used herein, refers to an axis that is substantially perpendicular to a longitudinal axis.

II. Exemplary modalities

Exemplary embodiments are described below with reference to some illustrative embodiments. Although exemplary embodiments are described with respect to the use of an automated injection device to inject a dose of a therapeutic agent, one of ordinary skill in the art will recognize that exemplary embodiments are not limited to illustrative embodiments, and that exemplary automated injection devices they can be used to inject any suitable therapeutic agent into a patient. Furthermore, the exemplary automatic injection device components and the exemplary automatic injection device manufacturing and use methods 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 to facilitate gripping and handling of the device. The figures indicate a longitudinal axis L which runs substantially along the

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INSTl TUTO MEXICANO Dt LA PROPERTY long of the device 100, a first transverse axis' W ^ that runs substantially perpendicular to the longitudinal axis L of the device, and a second transverse axis V that runs substantially perpendicular to both the longitudinal axis L and the first transverse axis H .

In some exemplary embodiments, the exemplary length of device 100 may be approximately 10.2, 11.4, 12.2, 12.7, 14, 15.2, 16.5, 16.8, 17, 17.3, 17.5, 17.8, 19.1, 20.3, 21.6, 22.9, 24.1, 25.4 centimeters, but is not limited to these exemplary lengths. In some exemplary embodiments, the exemplary width of device 100 (at its widest site) may be approximately 1.3, 1.5, 1.8, 2,

2.3, 2.5, 2.8, 3, 3.3, 3.6, 3.8, 4.1, 4.3, 4.6, 4.8, 5.1, 5.3, 5.6, 5.8, 6.1,

6.4, 6.6, 6.9, 7.1, 7.4, 7.6 centimeters, but not limited to these exemplary widths. In some exemplary embodiments, the exemplary thickness of device 100 (at its thickest) may be approximately

0.3, 0.5, 0.8, 1, 1.3, 1.5, 1.8, 2, 2.3, 2.5, 2.79, 2.82, 2.84, 2.87, 2.9,

2.92, 2.95, 2.97, 3, 3.02, 3.05, 3.3, 3.6, 3.8, 4.1, 4.3, 4.6, 4.8, 5.1, 5.3, !

5.6, 5.8, 6.1, 6.4, 6.6, 6.9, 7.1, 7.4, 7.6 centimeters, but not limited to these exemplary thicknesses. In an exemplary embodiment, device 100 may have an exemplary length of approximately 16.99 centimeters, an exemplary width of approximately 3.71 centimeters at its widest, and an exemplary thickness of approximately 2.92 centimeters at its thickest. In another exemplary embodiment, device 100 may have an exemplary length of approximately 12.19 centimeters, an exemplary width of approximately 2.03 centimeters at its widest, and an exemplary thickness of

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MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL _ approximately 1.52 centimeters at its thickest part. The exemplary dimensions of the cited exemplary devices allow the device to be comfortably and ergonomically held by the grip of a user's hand. This allows a user to reliably and comfortably grasp and manipulate the device to perform an injection.

Exemplary automatic injection device 100 may include an external housing 101 for housing a container, such as a syringe or cartridge. The container can be pre-filled with a dose of a therapeutic agent to be injected into the body of a patient. The device housing 101, in its assembled form, can be any suitable size and shape to hold and dispense the dose of the therapeutic agent. The assembled housing 101 can be shaped that is designed and configured to be comfortable for 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 longitudinal axis L is much greater than its width taken along a first transverse axis H and its thickness taken along a second transverse axis V. An exemplary ratio of the length to width (at the widest site) of the device can be, without limitation, 2: 1, 3: 1, 4: 1, 5: 1, 6: 1, 7 : 1, 8: 1, 9: 1, 10: 1, all ratios in between, etc. An exemplary ratio of length to thickness (at the thickest site) of the device can be, without limitation, 2: 1, 3: 1, 4: 1,

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5: 1, 6: 1, 7: 1, 8: 1, 9: 1, 10: 1, all Intermediate ratios, etc.

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, housing 101 of 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 greater in a proximal portion 106 of the housing 101 than in 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 held and manipulated. comfortably and ergonomically by the hand of a user.

The housing 101 of the device 100 can be formed of a plurality of body components that are assembled together. In an exemplary embodiment, the housing 101 may be formed of a first body portion 116 and a second body portion 118 which, when cooperatively engaged with each other along their peripheral edges, enclose and provide a cavity between the two. The first and second body portions may be cooperatively engaged with each other using any suitable technique including, without limitation, adhesion, gluing, ultrasonic welding, friction fit, snap fit, interference fit, screws, bonding between projections and corresponding gaps. , etc. One skilled in the art will recognize that, in other exemplary embodiments, the cavity of the

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Device can be enclosed in a single body component or in three or more body components when assembled together.

A fire button 120 may extend from a surface of the first body portion 116. The fire button 120, when activated by a user, can cause the device 100 to perform an injection. In an exemplary embodiment, a recessed or concave portion 126 may be provided on the first body portion 116 that abuts the fire button 120 to facilitate activation of the fire button 120. The recessed portion 126 may surround the fire button 120 in an exemplary embodiment to accommodate a finger of a user when the user presses the fire button 120.

A transparent inspection window 128 may be provided on one surface of the first body portion 116 to allow a user to view the contents of device 100. Transparent inspection window 128 may allow the user to view the therapeutic agent contained in device 100 , for example, to ensure agent clarity and to see an injection end 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 pointed or rounded edges), an elongated elliptical shape, etc., 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 modalities, a relationship between the length and width of the

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Inspection window can include, without limitation, 1.5: 1, 2.0: 1, 2.5: 1, 3.0: 1, 3.5: 1, 4.0: 1, 4.5: 1, 5: 1, all ratios in between, etc.

A proximal end end 172 of the device housing may be provided to cover the proximal end of the device 100. In an exemplary embodiment, the proximal end end 172 may mate with the proximal end of the assembled first and second body portions. The proximal terminal end 172 can be 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 a portion of the outer surface of the proximal end 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 outer surface of the proximal end end 172 may be covered by an overmolded grip surface 173. Corresponding recesses may be provided on the outer surface of the proximal end end 172 to accommodate the grip surfaces.

A removable distal cap 164 6e may mate with the distal end of the assembled first and second body portions to cover the distal end of device 100 to prevent exposure of the injection needle prior to an injection. The distal cap 164 protects against accidental and / or unwanted contact by a user with the injection needle. The distal cap 164 also protects the injection needle.

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INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL against damage and contamination when the device is not in use. The end cap 164 can be any suitable size and shape. In an exemplary embodiment, end cap 164 may have a substantially tubular configuration with a substantially oval or elliptical shape. In an exemplary embodiment, a front surface of the end cap 164 may have a concave cutout portion 168 to accommodate part of the Inspection window 128.

In an exemplary embodiment, the outer surface of the end cap 164 may be devoid of overmolded gripping surfaces. In other exemplary embodiments, the outer surface of distal cap 164 may be overmolded with one or more gripping surfaces 165 to facilitate gripping and removal of distal cap 164 from the device. In an exemplary embodiment, the entire outer surface of the end cap 164 may be covered by an overmolded gripping surface 165.

Corresponding recesses may be provided on the outer surface of the end cap 164 to accommodate the gripping surfaces.

In an exemplary embodiment, one or more ridges (which protrude from the outer surface) and / or one or more slots or holes (which are recessed toward the outer surface) may be provided in the gripping surfaces 165 on the end cap 164, to further facilitate the grip and manipulation of the device. The shapes and locations of the ridges and / or grooves can be altered at will and any desired number of ridges and / or grooves can be provided. In an exemplary embodiment, the ridges and / or grooves may extend substantially perpendicular to the longitudinal axis L of the device. In

<img file="MX337208B_D0026.tif" />

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0027.tif" />

In an exemplary embodiment, grip surfaces 165 may include textured surfaces to enhance tactile sensation and further facilitate firm grip of the device. In an exemplary embodiment, the end cap 164 may include one or more projections 170a, 170b (shown in Figure 5) that extend outwardly from the front surface and the rear surface of the distal cap 164 to further facilitate grasping of the cap. 164.

In an exemplary embodiment, end cap 164 may frictionally engage with a recessed or stepped portion of the housing to be retained in position on the housing when the device is not in use. In an exemplary embodiment, end cap 164 may include a protrusion to lock and / or attach the cap to the housing until the user is ready to perform an injection. Any suitable coupling mechanism can be used in accordance with the teachings of the exemplary embodiments.

When the proximal end 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 body portions 116, 118, abutting gripping surfaces 173 on proximal end 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 ends of the device abutting the firing button 120. The recessed portions allow the user's hand to be accommodated in a comfortable position when the stop button is depressed. Shooting

120.

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0028.tif" />

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 handling of the device. In an exemplary embodiment, two gripping surfaces 154, 156 may be provided on opposite side surfaces of the device. A first gripping surface 154 may abut a first recessed portion 122, and a second gripping surface 156 may abut a second recessed portion 124. Corresponding recesses may be provided on the outer surface of the first body portion 116 to accommodate the surfaces. grip.

In an exemplary housing for an automatic injection device, a first overmolded grip region, a second overmolded grip region, and a recessed region abutting the first and second overmolded regions may be provided. The first overmolded grip region, the second overmolded grip region, and the recessed region can cooperatively provide an ergonomic and comfortable grip area in which a user can grasp the automatic injection device to perform an injection.

In this exemplary embodiment, the first overmolded grasping region may be formed by the proximal end end 172 having an overmolded outer surface or cover. The second overmolded grip region can be formed as a part of the

11V1 Γ 1

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL assembly of the first body portion 116 and the second body portion 118 having one or more overmolded gripping surfaces (eg, gripping surfaces 154, 156). In an exemplary embodiment, the second overmolded grip region may have a substantially tapered tubular structure to provide an ergonomic fit with a user's hand. The recessed region abutting the first and second overmolded grip regions may be formed by an assembly portion of the first body portion 116 and the second body portion 118 that is narrower in width than the first overmolded grip region. and the second overmolded grip 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 overmolded gripping surfaces.

Figure 3 illustrates a schematic 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 flat front surface (extending substantially along the LH plane ) and left and right lateral surfaces (extending substantially along the LV plane). The front surface of the first body portion 116 can be contiguously and integrally transformed into the left and right side surfaces of the first body portion 116. The edges at which the front surface transforms into the side surfaces can be pointed, o smooth and where to keep

MEXICAN INSTITUTE

OF THE PROPERTY You go «e¿3

INDUSTRIAL a rhodynamic 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 fits ergonomically 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 skilled 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 flat front surface (extending substantially along the plane L₇H) and left and right lateral surfaces (extending substantially along the LV plane). The front surface of the second body portion 118 can be contiguously and integrally transformed into the left and right side surfaces of the second body portion 118. The edges where the front surface transforms into the side surfaces can be pointed, or smooth and rounded 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 fits ergonomically 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.

<img file="MX337208B_D0029.tif" />

As illustrated in FIG. 3, the first body portion 116 and the second body portion 118 can be cooperatively coupled with one another along their peripheral edges to enclose and provide a cavity 102 between them. The second and upper body portions can be cooperatively coupled with one another using any suitable joining technique including, without limitation, adhesion, gluing, ultrasonic welding, friction fit, snap fit, interference fit, screws, interlocking bonding. and corresponding gaps, etc. The skilled artisan will recognize that, in other exemplary embodiments, the cavity of the device 102 may be enclosed in a single body component or in three or more body components when assembled together.

Preferably, an exemplary container 160 is slidably positioned in cavity 102 and engages an injection needle (not shown) at a distal end. The injection needle can be covered with 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 container 160 within and with respect to the housing, and to propel the therapeutic agent from container 160 to perform an Injection. The container advancement mechanism may include one or more actuators (eg, one or more diverting members) that move the container from a covered position to a projecting position. When the device is in a pre-injection state, the container 160 may be in a position

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0030.tif" />

covered, that is, retracted within the housing. When the device is actuated, the container advancement mechanism can advance the container 160 to a projecting position, such that the injection needle projects from a distal end of the housing to allow the therapeutic agent to be propelled into the body. of the patient. The distal end of the housing may include an opening through which the needle can project.

The cavity 102 within the housing may also accommodate a firing engagement mechanism, for example, firing button 120. Firing button 120, when actuated by depressing, activates the container advancement mechanism which, in turn, advances container 160 toward the injection site, drives the injection needle toward the injection site, and delivers the therapeutic agent to the injection site. In an exemplary embodiment, at least a portion of the external surface of the fire button 120 may be overmolded with one or more rubber covered gripping surfaces to facilitate depressing the fire button with a finger or hand of the user. In an exemplary embodiment, the entire outer surface of the fire button may be covered by an overmolded grip surface. In an exemplary embodiment, the gripping surfaces on the fire button 120 can be made a different color from the non-gripping surfaces, to provide the visual ability to indicate which area of ​​the device is to be gripped. For example, the grip surfaces on the fire button 120 may be green, while all other surfaces on the device may be green.

<img file="MX337208B_D0031.tif" />

INSTITUTO MEXICANO DE LA PROPERTY one or more colors other than green. industrial

Figure 3 shows that a surface frerrtBt^rixte- ° Tar^{, t}The body portion 116 may include a first opening 119, through which the fire button 120 may protrude out of the front surface. An exemplary aperture 119 may be circular to accommodate fire 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 opening 127 to accommodate the transparent inspection window 128.

As illustrated in FIG. 3, in an exemplary embodiment the removable end cap 164 may frictionally engage with a recessed or stepped portion 166 of the housing to be retained in place in the housing when the device is not in use.

Figure 4 illustrates a front surface of first body portion 116 of exemplary automatic injection device 100. Figure 5 illustrates a left-side view of first body portion 116 and second body portion 118 assembled in device 100 .

As illustrated in FIG. 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 gradually and slightly widens to a larger width (width w2) at the distal end of the proximal terminal end 172. The proximal end of the first portion body 116

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL abutting the proximal terminal end 172 ~ may inelute one or more recessed portions 122, 124, on the sides. The recessed portions 122, 124 can create a narrow neck 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 can be widened to a greater width of the device (width W) and can gradually taper to a narrower width (width w4) near the middle 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). The second body portion 118 may have a shape and configuration substantially similar to the first body portion 116. As illustrated in Figure 5, in an exemplary embodiment the removable end cap 164 may include one or more projections 170a, 170b (shown in FIG. 5) extending outwardly from the front surface and the rear surface of the distal cap 164 to further facilitate gripping of the distal cap.

One skilled in the art will recognize that other forms of exemplary automatic injection device 100 are possible.

As illustrated in Figures 4 and 5, in an exemplary embodiment a left gripping surface 130 may be provided to partially cover, and extend across, the left lateral surface of the first body portion 116, and a right gripping surface 132 to partially cover, and extend across,

ΙΜΡΙ

MEXICAN INSTITUTE

OF PROPERTY Vfesajgji the right lateral surface of the first portion of cuéf'P ^ 'Tl 6. έπτ an exemplary embodiment, each gripping surface 130, l32^,1These are provided between the firing button 120 and the inspection window 128. One of ordinary skill in the art will recognize that other locations of the gripping surfaces 130, 132 are possible. Similarly, in an exemplary embodiment, a left grip surface 152 may be provided to partially cover, and extend across, the left side surface of the second body portion 118, and a right grip surface 153 may be provided to partially 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 grip surfaces 130, 152 may form a contiguous left grip surface 154 on the housing, and the right grip surfaces 132, 153 may form a right grip surface adjoining 156 on the accommodation. The adjoining left and right grip surfaces 154, 156, facilitate reliable and comfortable grip and manipulation of the device by the hand of a user, which dramatically and surprisingly improves the experience of physically weak users, for example, older users and users have rheumatoid arthritis.

In user tests performed using the exemplary automatic injection devices, test participants liked the over-molded grip surfaces on the sides of the device, the ridges on the over-molded grip surfaces, and the relatively large size and ergonomic shape.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0032.tif" />

Of the device. The majority of test participants (58%) had a strong preference for handling and grasping an exemplary automatic injection device of the present invention. Overall, the sample device configuration received a high average rating of 8.1 out of 10.0. Overmolded grip surfaces were the main factor in participants' high scores of the example device for handling and grip. For various wear factors, there was a significant positive correlation between the Cochin scores and the example device of the present invention with the overmolded grip surfaces, indicating that the example device of the present invention is very suitable for users. with hand dysfunction.

One skilled in the art will recognize that the left and right gripping surfaces may have different sizes, shapes and configurations from the exemplary sizes, shapes and configurations shown in Figures 1-8. One skilled in the art will recognize that more or fewer gripping surfaces can be provided on exemplary automatic injection devices than the exemplary left and right gripping surfaces shown in Figures 1-8. One skilled in the art will also recognize that exemplary automatic injection devices may place one or more gripping surfaces at positions other than the exemplary positions shown in Figures 1-8. Furthermore, the person skilled in the art will recognize that in some exemplary embodiments the contour of each gripping surface may have a configuration

MEXICAN INSTITUTE

..,. . . I- FROM THE PROPERTY WJ5a J aerodynamic, round, smooth. industrial

Overmolded gripping surfaces— ^ pauisias__e.n ___ Exemplary embodiments may be formed of any suitable material that provides a high-friction, soft-touch first feel to a user, compared to portions of the device that lack a gripping surface. Overmolded that provide a low friction, hard second feel to a user. The difference in sensory perceptions provides the possibility of touch to a user, indicating that the device should be grasped in the regions provided with the over-molded gripping surfaces.

In an exemplary embodiment, the overmolded gripping surfaces can be formed of a first type of material that has a soft, high friction feel to a user, while the portions of the device lacking the overmolded gripping surfaces can be form of a second type of material that has a harder and low friction feel to a user. In an exemplary embodiment, the overmolded gripping surfaces can be formed from a first material with a lower hardness, while the non-gripping surfaces can be formed from a second material with a higher hardness.

For example, the non-grip surfaces can 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 feel to the user. Rigid thermoplastics can include materials

MEXICAN INSTITUTE 'OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0033.tif" />

such as polypropylene (PP), polyethylene (PE), polystyrene (PS), high impact polystyrene (HIPS), polycarbonate (PC), acrylonitrilobutadiene-styrene (ABS), polyethylene terephthalate (PET), polyamide (PA ), PC / ABS mix, and PPO / PS mixes.

Exemplary overmodeled gripping surfaces can be formed of materials having any suitable grade and material hardness to provide a high friction, soft touch feel to the user. Exemplary overmolded grip surface materials may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanizate (TPV), etc. Exemplary thermoplastic elastomers that can be used to form the exemplary overmolded gripping surfaces include, without limitation, TPEs from KRAIBURG, TPE Dynaflex ™ from PoIyOne, TPE Versaflex ™ from PoIyOne, TPE Versollan ™ from PoIyOne, TPE OnFlex ™ from PoIyone, etc. . Exemplary thermoplastic vulcanizates that can be used to form the exemplary overmolded gripping surfaces include, without limitation, ExxonMobil Santoprene ™ thermoplastic, and the like.

In an exemplary embodiment, the overmolded gripping surfaces can be made a different color from the non-gripping surfaces to provide the visual ability to indicate which area of ​​the device is to be gripped. For example, the left and right overmolded gripping surfaces can be d brown, while the non-gripping surfaces d I

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0034.tif" />

housing can be gray.

As illustrated in figure 5, one or more ribs (protruding from the outer surface) and / or one or more slots or holes (which are recessed toward the outer surface) can be provided on an exemplary -TiiudullLlUd 158a, 158b , 158c (illustrated in Figures 5 and 6B) on the left overmolded grip surface 154, and / or the right overmolded grip surface 156, to further facilitate gripping and handling of the device. The shapes and locations of the ridges and / or grooves can be altered at will and any desired number of ridges and / or grooves can be provided. In an exemplary embodiment, the ridges and / or grooves may extend substantially perpendicular to the longitudinal axis L of the device. In an exemplary embodiment, the overmolded gripping surfaces may include textured surfaces to enhance tactile feel and further facilitate firm grip of the device.

Figure 6A is a close-up front 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 close-up view of the left side of the 20 exemplary left overmolded gripping surface 130 of FIG. 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, 25 may be of similar structure and configuration.

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0035.tif" />

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 one 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, 10 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, terminating 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 with the first horizontal side 140. In an exemplary embodiment, the first horizontal side 140 may include a beveled edge that extends toward the first longitudinal side 134 at an angle relative to the 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 larger than the first horizontal side 140. An exemplary ratio of the length of the first longitudinal side 134 to the

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0036.tif" />

length of the first horizontal side 140 may include, without limitation, approximately 2: 1, 2.5: 1, 3: 1, 3.5: 1, 4: 1, 4.5: 1, 5: 1, all ratios in between, etc.

A distal end 144 of the first longitudinal side 134 may extend toward, and connect to, an end 146 of a second horizontal side 148 of the left overmolded gripping surface 130. In an exemplary embodiment, a connecting side 150 extends between the ends 144, 146, may connect the first longitudinal side 134 with the second horizontal side 148. In an exemplary embodiment, the connecting side 150 may have a greater length than the connecting side 142. In exemplary embodiments, a ratio of the length of the connection side 150 to the length of the connection side 142 may include, without limitation, 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, etc., but 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, terminating at the peripheral edge of the first body portion 116.

In an exemplary embodiment, the first longitudinal side 134 may be substantially larger than 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 any horizontal side may include, without limitation limitation, approximately 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 ratios intermediate, etc.,

IMPI but is not limited to these exemplary relationships.

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0037.tif" />

Figure 7 is a bottom view of an exemplary romovibto diotol mole 164 showing the overmolded grip surface 165. The overmolded grip surfaces 165 may be formed of any suitable material that first provides a soft and high feel to the touch. friction for a user, as compared to portions of the device that lack an overmolded gripping surface that provides a hard, low friction feel to a user. The difference in sensory perceptions provides the possibility of touch to a user, indicating that the device should be grasped in the regions provided with the over-molded gripping surfaces.

In an exemplary embodiment, the overmolded gripping surfaces can be formed from a first type of material having a high friction soft feel, while the non-gripping surfaces are formed from a second type of material having a high friction. low friction hard touch feel. Exemplary overmolded gripping surfaces 165 can be formed of materials having any suitable grade and material hardness to provide a high friction soft touch feel to the user. Exemplary overmolded grip surface materials may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanizate (TPV), etc. Exemplary thermoplastic lastomers that can be used to form

<img file="MX337208B_D0038.tif" />

Exemplary overmolded gripping surfaces include, without limitation, TPEs from KRAIBURG, TPE Dynaflex ™ from PoiyOne, TPE Versaflex ™ from PoiyOne, TPE Versollan ™ from PoiyOne, TPE OnFlex ™ from PoIyone, etc. Exemplary thermoplastic vulcanizates that can be used to form the exemplary overmolded gripping surfaces include, without limitation, ExxonMobil's Santoprene ™ thermoplastic, and the like. In an exemplary embodiment, the overmolded gripping surfaces 165 can be made a different color from the non-gripping surfaces, to provide the visual ability to indicate which area of ​​the device is to be gripped. For example, the overmolded gripping surfaces 165 on the end cap 164 may be brown in color, while the non-gripping surfaces of the housing may be gray.

Figure 8 is a top view of an exemplary proximal end 172 for covering the proximal end of the housing. In an exemplary embodiment, the outer surface of proximal terminal end 172 may be devoid of any overmolded gripping surfaces. In other exemplary embodiments, at least a portion of the outer surface of the proximal end 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 outer surface of proximal terminal end 172 may be covered by an overmolded gripping surface 173.

The overmolded gripping surfaces 173 can be formed from any suitable material that provides a first feel to the

<img file="MX337208B_D0039.tif" />

soft, high-friction touch for a user, compared to portions of the device lacking an over-molded grip surface that provide a second, low-friction, soft-touch feel for a user. The difference in sensory perceptions provides the possibility of touch to a user indicating that the device should be gripped in the regions provided with the overmolded gripping surfaces.

In an exemplary embodiment, the overmolded gripping surfaces 173 can be formed of a first type of material having a high friction soft feel, while the non-gripping surfaces are formed of a second type of material having a harder, low-friction feel. Exemplary overmolded gripping surfaces 173 can be formed of materials having any suitable grade and material hardness to provide a high friction soft touch feel to the user. Exemplary overmolded grip surface materials may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanizate (TPV), etc. Exemplary thermoplastic elastomers that can be used to form the exemplary overmolded gripping surfaces include, without limitation, TPEs from KRAIBURG, TPE Dynaflex ™ from PoIyOne, TPE Versaflex ™ from PoIyOne, TPE Versollan ™ from PoIyOne, TPE OnFlex ™ from PoIyone, etc. . Exemplary thermoplastic vulcanizates that can be used to form the overmolded gripping surfaces

IMPI

Examples include, without limitation, ExxonMobil Santoprene ™ thermoplastic, etc. In an exemplary embodiment, the overmolded gripping surfaces 173 can be made a different color from the non-gripping surfaces, to provide the visual ability to indicate which area of ​​the device is to be gripped. For example, the overmolded gripping surfaces 173 on the proximal terminal end 172 may be brown in color, while the non-gripping surfaces of the housing may be gray in color.

In an exemplary embodiment, one or more ridges (which protrude from the outer surface) and / or one or more slots or holes (which are recessed toward the outer surface) may be provided on the outer surface of the proximal terminal end 172, to facilitate plus the grip of the proximal portion of the device. The shapes and locations of the ridges and / or grooves can be altered at will and any desired number of ridges and / or grooves can be provided. In an exemplary embodiment, the overmolded grip surfaces 173 may include textured surfaces to enhance tactile feel and further facilitate firm grip of the device. In an exemplary embodiment a wraparound groove may be provided

174 around the circumference of proximal terminal end 172, and a concave or recessed surface 176 may be provided on top of proximal terminal end 172 to orient and guide a user's hand and fingers in the device. For example, the concave or recessed surface 176 can accommodate a finger on the surface

176 while the user performs an injection using I device.

<img file="MX337208B_D0040.tif" />

ΙΜΡΙ

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0041.tif" />

In some exemplary embodiments, housing 101, removable end cap 164, and / or proximal end end 172 of device 100 may further include graphics, symbols, and / or numbers to facilitate use of the automatic injection device. For example, distal cap 164 may include a representation of an arrow on an external surface pointing toward 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. ). The person skilled in the art will recognize that the automatic injection device may have any suitable graphic, symbol and / or number to facilitate patient instruction, or the automatic injection device may omit such graphics, symbols and / or numbers.

Figure 9 is a flow chart of an exemplary method for assembling an automatic injection device. In an exemplary embodiment, a housing of an automatic injection device can be provided in two or more separate housing components (eg, first and second body portions), which can be coupled to each other during assembly of the device.

In step 902 a first portion of the housing is provided or formed. In step 904, one or more gripping surfaces are overmolded over corresponding recesses in the outer surface of the first body portion, to facilitate gripping and handling of the device during an injection.

In step 906 a second housing body portion is provided or formed. In step 908, one or more one or more

IMPI

INSTITUTO MÉXIvANO ¿E LA PROPERTY IflBUETRIAJ.

<img file="MX337208B_D0042.tif" />

Gripping surfaces are overmolded over corresponding recesses in the outer surface of the second body portion, to facilitate gripping and handling of the device during an injection.

In step 910 a proximal end end of the housing is provided or formed. In step 912, one or more one or more gripping surfaces are overmolded over corresponding recesses in the outer surface of the proximal terminal end, to facilitate gripping and handling of the device.

In step 914 a removable end cap of the housing is provided or formed. In step 916, one or more gripping surfaces are overmolded over corresponding recesses in the outer surface of the distal cap, to facilitate removal of the distal cap prior to performing an injection.

In step 918 a housing firing button is provided or formed. In step 920, one or more gripping surfaces are overmolded onto the outer surface of the fire button to facilitate activation of the fire button to perform an injection.

At step 922, one or more internal components of the automatic injection device may be placed in a cavity defined between the upper and lower body portion. Exemplary device components may include, without limitation, a container (eg, a syringe) prefilled with a therapeutic agent for injecting into a patient, an injection needle coupled to a distal end of the container, a container advance mechanism.

MEXICAN INSTITUTE

OWNED by CecwS

INDUSTRIAL to advance the container into and with respect to the e) injection site and to propel the therapeutic agent from the container during an injection, a firing button to activate the container advancement mechanism, etc.

In step 924, the second and upper body portions can be cooperatively coupled to form a body assembly that encloses and retains the internal components within the cavity. In an exemplary embodiment, the body portions can be engaged at their peripheral edges. Any suitable coupling or joint may be used in step 924 including, without limitation, adhesion, gluing, ultrasonic welding, friction fit, press fit, interference fit, corresponding screws, protrusions and gaps, etc.

At step 926, the removable distal cap can be removably engaged at a distal end of the body assembly to cover an injection needle or a needle shield which, in turn, covers the injection needle.

In step 928, the proximal end end can be engaged in a proximal end of the body assembly.

Any suitable manufacturing technique can be used to form any of the device components, including, without limitation, injection molding. The device components can be formed of any suitable material including, without limitation, plastic, thermoplastic, polycarbonate, metal, etc.

It should be noted that the order of the steps outlined herein can be altered at will, and that other steps / techniques are possible.

MEXICAN INSTITUTE

<img file="MX337208B_D0043.tif" />

OF THE PROPERTY manufacture and are considered within the spirit and scope of^rand^{&gt; u}fa "'pre§ invention.

User tests of the automatic invection device

Forty-four test participants were recruited to test both the exemplary automatic injection devices of the present invention having overmolded gripping surfaces, and four alternating automatic injection devices without the gripping surfaces. Most of the participants had rheumatoid arthritis (RA) at the time of the test. Participants were diagnosed with RA 1 to 40 years earlier, with an average time of diagnosis of 9 years. Four participants had Crohn's disease at the time of the test.

Test procedure

Each participant tested the different exemplary automatic injection device configurations. In particular, in one phase of using the exemplary device, each participant performed a sham injection (ie, an injection with cut needles and without medication) using the devices. After the participant performed the sham injection, each 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 for example questions about size, shape, ease of handling, grip comfort, general user experience, etc.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0044.tif" />

Device Handling and Grip -After performing simulated injections using the different device configurations, participants were asked to provide feedback and comparative scores on handling and grip, general ease of use, and comfort when performing the injection steps. All device configurations were rated on a scale from 1 (very negative) to 10 (very positive).

The majority of participants (58%) had a strong preference for handling and gripping the exemplary device configuration of the present invention compared to four alternate device configurations that did not include overmolded grip surfaces. Participants particularly preferred the rubber overmolded grips on the side of the exemplary device and its relatively large size, which make holding the exemplary device easy and comfortable. Rubber overmolded grips were the main factor in the high scores that participants gave to the exemplary device configuration for handling and grip, as taught herein.

In addition, a correlation analysis on hand dysfunction was done using the Cochin Hand Disability Scale with the scores provided for some factors of use: handling and grip, ease of use, ease of starting and performing an injection, comfort at hand. perform an injection, acceptance and overall performance. For various usage factors there was a significant positive correlation between Cochin scores and device configuration

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0045.tif" />

exemplary of the present invention, indicating that this exemplary device configuration is well suited for users with hand dysfunction.

Comfort of holding and use of the device

When performing simulated injections in the wearing phase of the exemplary device, test participants were asked to rate comfort in holding the exemplary device configuration of the present invention and four alternate device configurations that do not include overmolded gripping surfaces. Participants rated each device configuration on a scale of 1 (very low confidence) to 7 (very high confidence). Most of the participants preferred the exemplary device configuration of the present invention for its convenience in performing the injection steps, with 45% giving the highest rating.

Ease of use and handling of the device

Following initial exposure to the exemplary device and prior to receiving instructions or a demonstration of use, test participants were asked about the perceived ease of use of the exemplary device configuration of the present invention and four alternate device configurations. that do not include overmolded gripping surfaces. Participants rated each device configuration on a scale from 1 (very difficult) to 7 (very easy). All device configurations received high

IMPI scores s for perceived ease of use.

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0046.tif" />

After performing simulated injections in the use phase of the real device, the test participants were asked to rate the ease of handling of each device configuration. Participants rated each device configuration on a scale of 1 (very low confidence) to 7 (very high confidence). In addition, after performing the simulated injections using the device configuration in the third phase of using the real device, participants were also asked to rate the configuration on its general usability on a scale of 1 (very difficult) to i 10 ( very easy).

The majority of participants (42%) found the exemplary device configuration of the present invention to be easier to use compared to four alternate device configurations that do not include overmolded gripping surfaces. Overall, the exemplary device configuration of the present invention received a high average score of 7.97 out of 10.0.

Device size

After performing simulated injections in the use phase of the exemplary device, test participants were asked to rate the overall size of the exemplary device configuration of the present invention and four alternate device configurations that do not include overmolded gripping surfaces, on a scale from 1 (very low confidence) to 7 (very high confidence). Overall, all device configurations received positive scores for

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX337208B_D0047.tif" />

its general shape. In general, participants who struggled to form a tight fist preferred the larger devices. The exemplary device configuration of the present invention generally received the highest scores.

Device shape

After performing simulated injections in the actual device use phase, test participants were asked to rate the overall shape of the exemplary device configuration of the present invention and four alternate device configurations that do not include overmolded gripping surfaces, on a scale from 1 (very low confidence) to 7 (very high confidence).

All device configurations generally received positive scores for their overall size. Overall, test participants who struggled to form a tight fist preferred the larger devices. With regard to the configuration of the exemplary device of the present invention, many participants found that the shape fits comfortably in their hand.

III. Incorporation by reference

The contents of all references, including patents and patent applications cited throughout this application, are incorporated herein by reference in their entirety. Appropriate components and methods from those references can be used for the invention.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX337208B_D0048.tif" />

and the modalities of the same. Furthermore, the components and methods identified in the Background section are integral with this disclosure and may be used in conjunction with, or substitute for, the components and methods described elsewhere in the disclosure within the scope of the invention.

IV. Equivalents

In describing exemplary modalities, specific terminology is used for clarity. For descriptive purposes, each specific term is intended, at the very least, to include all technical and functional equivalents that operate in a similar manner to achieve a similar purpose. Additionally, in some cases where a particular exemplary embodiment includes a plurality of system elements or method steps, the elements or steps may be replaced with a single element or step. Similarly, a single element or step can be replaced with a plurality of elements or steps that serve the same purpose. In addition, when parameters are specified for various properties in exemplary modes, the parameters can be adjusted up or down by one twentieth, one tenth, one fifth, one third, one half, etc., or by rounded approximations thereof, to unless otherwise specified. Furthermore, although exemplary embodiments have been shown and described with reference to particular embodiments thereof, those skilled in the art will understand that various substitutions and alterations can be made in form and detail.

<img file="MX337208B_D0049.tif" />

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL ——- without deviating from the scope of the invention. Furthermore, other aspects, functions and advantages are also within the scope of the invention.

Exemplary flow charts are provided for illustrative purposes and are non-limiting examples of the 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 flow charts, and that the steps in the exemplary flow charts may be performed in a different order than that shown.