Automatic injection devices having overmolded gripping surfaces.

(54) Title: AUTOMATIC INJECTION DEVICES HAVING OVERMOLDED GRIP SURFACES.

(54) Title: AUTOMATIC INJECTION DEVICES HAVING OVERMOLDED GRIPPING SURFACES.

(57) Summary

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

(57) Abstract

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.

PATENT TITLE No. 360402

Headlines):

Home:

Denomination:

Classification:

Inventors):

ABBVIE BIOTECHNOLOGY LTD.

Clarendon House 2 Church Street, HM 11, Hamilton, BERMUDAS

AUTOMATIC INJECTION DEVICES WITH OVERMOLDED GRIP SURFACES.

......... ....... | F,_:| F IF. EIGER; MARK KURTH; SABRINA KATZ;

CIP:

CPC:

A61M5 / 31

A61M5 / 31

JOSEPI ADAI

<img file="MX360402B_D0001.tif" />

ULIAN; CHUAN JAMES C. STAI

Number

MX / a / 2016/002081

<img file="MX360402B_D0002.tif" />

Validity: Twenty years

Expiration Date: Issue Date

The reference patsnte is awarded with i

In accordance with the ai from the date of presenl

Who subscribes to the present title i (Official Gazette of the Federation 26/01/2006, 06/05/2009. 06/01/20110, and 12 * sections I and III of the Rule:

07/28/2004 and 09/07/2007); Articles 1 ", 35

Industrial Property (DOF, 12/27/1999, n powers in the Deputy General Directors! Departmental Coordinators and other subordinates 07/29/2004, 08/04/2004 and 09/13/2007).

Country:

<img file="MX360402B_D0003.tif" />

International:

012 Non-extendable, counted in beds.

the Industrial Property Law

999, 01/26/2004, 06/16/2005, the 1 * 3 · fraction V subsection a), 4^Sthe 01/07/2002, 07/15/2004, or Organic of the Mexican Institute of the 3 * and 5 * subsection a) of the Agreement that delegates Regional, Divisional Deputy Directors,. (DOF 12/15/1999. Amended on 04/022000,

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3rd of its Regulations, and 1 fraction III, 2 fraction V. 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

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Arenal

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

Original string :

NAHANNY MARISOL CANAL REYESjOOOOl 000000403,252793 | Tax Administration Service | 1695 || MX / 2019/4871 | MX / a / 2016/002081 [Normal patent title with divisional PCT | 1220jRRGO | Page (s) [agKRBZe: 3rolq + l9s1 DPDPOLYcU.

Digital stamp:

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1, Pueblo Sarna Mar ra Tepepain ,, Xochimflco, 16020, (55) 53340700 www.góD.rnwliTtpi

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AUTOMATIC INJECTION DEVICES

OVERMOLDED GRIP SURFACES

<img file="MX360402B_D0006.tif" />

RATED APPLICATIONS

This application is a non-provisional application and claims the priority of the US provisional patent application. USA No. 61 / 435,465, filed on January 24, 2011, the full content of which is expressly incorporated herein by reference in its entirety.

BACKGROUND

Automatic injection devices offer an alternative to manually operated syringes for administering therapeutic agents into the patient's body, and allow patients to self-administer therapeutic agents. Automatic injection devices can be used to administer medications in emergency conditions, for example to administer eplnephrine 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 Pat. USA Nos. 3,910,260; 4,004,577; 4,689,042; 4,755,169; and 4,795,433; the full content of which is incorporated herein by reference in its entirety. Various types of automatic injection devices are also described, for example, in

USA 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 entire content of which is incorporated herein by reference in its entirety.

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

In accordance with an exemplary embodiment, an automatic injection device is provided with a cavity release to accommodate a container. A first overmolded gripping surface is provided that extends longitudinally along a portion of the housing on a first outer surface of the housing. A second over-molded gripping surface is provided that extends longitudinally along a portion of the housing on a second external surface of the housing opposite the first external 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 to the touch, and the non-gripping surfaces of the housing are formed of a second material that has a second perception 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 higher second hardness .

In an exemplary embodiment, the automatic injection device includes a removable distal cap to protectively cover an injection needle attachable to the container; an external surface of the distal cap including an overmolded gripping surface to facilitate grasping and removal of the distal cap. In an exemplary embodiment, the automatic injection device includes a trigger button that protrudes from an opening in the housing, and includes an overmolded contact surface to facilitate actuation of the trigger button by a user.

Exemplary, the Automatic Injection device includes a proximal terminal end to cover a proximal end of the automatic injection device, the proximal terminal end having an external overmolded surface. In an exemplary embodiment, an upper surface of the proximal end end includes a cupped surface to direct and facilitate accommodation of a user's hand or fingers to grasp 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 that encloses a cavity to accommodate a container. The method includes overmolding, on the housing, a first gripping surface that extends longitudinally along a portion of the housing on a first external surface of the housing. The method also includes overmolding, on the housing, a second gripping surface that extends longitudinally along a portion of the housing on a second external surface of the housing opposite the first external surface.

In an exemplary embodiment, the first and second gripping surfaces of the housing are formed of a first material having a first feel to the touch, and the non-gripping surfaces of the housing are formed of a second material having a second perception to the touch. touch. In an exemplary embodiment, the first and second gripping surfaces of the housing are formed of a first material having a first hardness, and the surfaces which are not formed of a second material having a higher second hardness.

In an exemplary embodiment, the method includes overmolding a grasping surface onto an outer surface of a distal cap to facilitate grasping and detaching of the distal cap, and mating 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 on a trigger button to facilitate activation of the trigger button, and providing the trigger button within the cavity such that a portion of the trigger 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 coupling the proximal terminal end to a proximal end of the housing. In an exemplary embodiment, an upper surface of the proximal end end includes a cupped surface to direct 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 over-molded grip region, a second over-molded grip region, and a hollowed region abutting the first and second over-molded grip region.

In an exemplary embodiment, the region fluffs between the first and second overmolded grip region. 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 hollowed 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 outer surface that is overmolded with a gripping surface. In an exemplary embodiment, the second overmolded grip region of the housing has a tapered tubular structure.

BRIEF DESCRIPTION OF THE DRAWINGS

The above objects, aspects, characteristics and advantages and other more of the exemplary modalities will become more evident and better understood by referring 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 wherein a removable distal cap is detached and shown separately from the device housing.

Figure 2 is a right side perspective view illustrating

Ί the exemplary automatic injection device of the

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.

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

Figure 7 is a bottom view of an exemplary removed distal cap of the exemplary automatic injection device of Figures

1-3.

FIG. 8 is a top view of an exemplary proximal terminal end of the exemplary automatic injection device of FIGS.

1-3.

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

DETAILED DESCRIPTION

Exemplary modalities provide automatic injection devices that have housings that are particularly designed and configured to be handled reliably, safely, ergonomically and comfortably by users. The exemplary modalities also provide housing components for automatic injection devices that are particularly designed and configured to be handled reliably, safely, ergonomically and comfortably by users. The exemplary embodiments also provide methods of 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 gripped and handled easily, comfortably and reliably by a user. Exemplary overmolded gripping surfaces are particularly configured and positioned over the housing to prevent slipping of the user's hands, and thus avoid harm to the user and others around them. Furthermore, the exemplary overmolded gripping surfaces are particularly configured and positioned to be ergonomic and comfortable for use, particularly by physically weak users, eg older users, users suffering from rheumatoid arthritis, etc.

In user tests conducted using 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, where overmolded gripping surfaces were the primary factor in test participants' high scores of exemplary handling and grip device configurations, in Comparison with devices without overmolded gripping surfaces. For various usage factors there was a significant positive correlation between Cochin scores and exemplary device configurations, indicating that exemplary devices are well suited 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 can 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 understanding of exemplary modalities.

The terms "automatic injection 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, where the device differs from a conventional syringe by the inclusion of a mechanism to automatically deliver the therapeutic agent to the patient by injection when the mechanism is attached.

The terms "container" and "container", 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 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 with an injection needle. That is, in exemplary embodiments, a syringe may be a cartridge with a pre-attached injection needle attached to its barrel portion.

Exemplary embodiments described herein may also be practiced with respect to a syringe and 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 It is stored in this prefilled form for a period before the 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 body of the patient. 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 can be indirectly coupled with 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 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, ie, prior to the start of delivery 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 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 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 can vary according to factors such as the disease state, age, sex, and weight of the patient, and the capacity of the antibody, antibody portion, or other inhibitor TNFa to elicit a desired response from the patient. A therapeutically effective amount is also one in which any toxic or deleterious effects of the antibody, antibody portion, or other TNFa Inhibitor are outweighed by the therapeutically beneficial effects. A "prophylactically effective amount", as used herein, refers to the doses and for the times necessary to achieve the desired prophylactic result. Typically, since the prophylactic dose is used in patients before disease onset, or at an early 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, or biochemical, that is capable of being administered in a therapeutically effective amount a patient using exemplary automatic injection devices. Exemplary therapeutic agents usable in exemplary automatic injection devices may include, without limitation, agents in a liquid state. These agents may include, without limitation, adalimumab (HUMIRA®) and proteins that are in a liquid solution, for example fusion proteins and enzymes. Examples of protein 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 (asparaglnase), Epogen (epoetin alfa), Enbrel (etanercept), Fabrazyme (beta agalsidase), Infergen (interferon alfacon-1), Intron A (interferon alfa-2a), Kineret (anakinra), MYOBLOC (botulinum toxin type B), Neulasta (pegfilgrastim), Neumega (oprelvekin), Neupogen (filgrastim), Ontak (d

PEGASYS (peginterferon alfa-2a), Proleukin (aldesleukin), Pulmozyme (dornase alfa), Rebif (interferon beta-1a), Regranex (becaplermin), Retavase (reteplase), Roferon-A (interferon alpha-2), TNKase (tenecteplase), and Xigris (Drotrecogin alfa), Arcalyst (rilonacept), NPIate (romiplostim), Mircera (metoxlpolletllengllcol-epoetln beta), Cinryze (C1 esterase inhibitor), Elaprase (¡dursulfasa), Myozyme (alglucosidase alfa) (abatacept), Naglazyme (galsulfasa), Kepivance (palifermln) and Actimmune (gamma-1b interferon).

The term "dose," as used herein, refers to an amount of a therapeutic agent, such as a TNFa inhibitor, which 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, 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 TNFa inhibitor adallmumab.

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

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

<img file="MX360402B_D0007.tif" />

treatment, for example by administering a TNFa inhibitor prii at week 0, followed by a second dose of a TNFa inhibitor in 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 harmful, for example, the 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, which is farthest from an injection site in a patient's body when the device is held against the patient for an injection or to imitate an injection.

The term "distal" refers to a portion, or end, or component of an exemplary automatic injection device, which is closest to an injection site in a patient's body when the device is held against the patient for an injection or to imitate an injection.

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

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

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

The term "rectangular as used in the present in the broad sense, means exactly rectangular or approximately rectangular within some tolerance from exactly rectangular.

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

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

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

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

The term "adjoining", as used herein in a broad sense, means immediately adjoining or approximately adjoining 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 modalities are described below with reference to some illustrative modalities. Although exemplary modalities are described regarding the use of an automatic injection device to inject a dose of a therapeutic agent, the skilled artisan will recognize that exemplary modalities are not limited to illustrative modalities, and that exemplary automatic injection devices they can be used to inject any suitable therapeutic agent into a patient. Furthermore, the components of exemplary automatic injection devices and the methods of manufacturing and use of exemplary automatic injection devices are not limited to the illustrative embodiments described below.

Figures 1-8 illustrate an exemplary automatic injection device, 100, which has one or more overmolded gripping surfaces to facilitate gripping and handling of the device. The figures indicate a longitudinal axis L running substantially along the device 100, a first transv axis substantially perpendicular to the longitudinal axis L of the device, and a second transverse axis V running 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 not limited to these exemplary lengths. In some exemplary embodiments, the exemplary width of device 100 (at its widest location) 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 is not limited to these exemplary widths. In some exemplary embodiments, the exemplary thickness of device 100 (at its thickest site) 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 it is 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 part, and an exemplary thickness of approximately 2.92 centimeters at its thickest part. 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 part, and an exemplary thickness of approximately 1.52 centimeters on its part. Exemplary dimensions of the aforementioned exemplary devices allow that the device is comfortably and ergonomically supported by the grip of a user's hand. This allows a user to reliably and comfortably grip and manipulate the device for injection.

Exemplary automatic injection device 100 may include an external housing 101 for accommodating 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 of any size and shape suitable for storing and dispensing the therapeutic agent dose. Assembled housing 101 may have a shape that is designed and configured to be comfortable for a user's hand, and so that the user can comfortably and reliably hold 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 length to width (at the widest place) 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 intermediate ratios, etc. An exemplary length to thickness ratio (at the thickest 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 relationships inte

FIG. 1 is a left-side perspective view illustrating an exemplary automatic injection device 100 having an external housing 101. FIG. 2 is a right-side perspective view of exemplary automatic injection device 100 of FIG. 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 supported 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, housing 101 may be formed of a first body portion 116 and a second body portion 118 which, when cooperatively coupled to one another along their peripheral edges, enclose and provide a cavity therebetween. The first and second body portions can be cooperatively coupled to each other using any suitable technique including, without limitation, adhesion, gluing, ultrasonic welding, friction fit, snap fit, interference fit, screws, joint between protrusions and corresponding gaps , etc. The person skilled in the art will recognize that, in other exemplary embodiments, the device cavity can be enclosed in a single compom three or more body components when assembled together.

A trigger button 120 can extend from a surface of the first body portion 116. The trigger button 120, when activated by a user, can cause 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 abutting the trigger button 120 to facilitate activation of the trigger button 120. The recessed portion 126 can surround trigger button 120 in exemplary mode to accommodate a user's finger when the user depresses trigger button 120.

A transparent inspection window 128 may be provided on a 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 clarity of the agent and to see an end of injection indicator that materializes at the end of a successful injection. An exemplary inspection window 128 can be substantially elongated in shape, eg, 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 modes, a relationship between the length and width of the inspection window may include, without limitation,

3.0: 1, 3.5: 1, 4.0: 1, 4.5: 1, 5: 1, all intermediate ratios, etc.

A proximal end end 172 of the device housing can be provided to cover the proximal end of device 100.

In an exemplary embodiment, the proximal end end 172 can be coupled with the proximal end of the assembled first and second body portions. The proximal end end 172 can be of any suitable size and shape. In an exemplary embodiment, the proximal end 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 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 outer surface of the proximal end end 172 may be covered by an overmolded gripping surface 173. Corresponding recesses can be provided on the outer surface of the proximal end end 172 to accommodate the gripping surfaces.

A removable distal cap 164 can be coupled 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 injection. Distal cap 164 protects against accidental and / or unwanted contact by a user with the Injection needle. Distal cap 164 also protects the Injection needle from damage and contamination when distal cap device 164 can be of 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 distal cap 164 may have a concave cut portion 168 to accommodate part of inspection window 128.

In an exemplary embodiment, the outer surface of distal cap 164 may lack 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 removing distal cap 164 from the device. In an exemplary embodiment, the entire outer surface of distal cap 164 may be covered by an overmolded gripping surface 165.

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

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

IMPIC

<img file="MX360402B_D0008.tif" />

An exemplary modality, grip surfaces textured surfaces to enhance the tactile feel and further facilitate firm grip 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 posterior surface of the distal cap 164 to further facilitate grip of the cap 164.

In an exemplary embodiment, the distal cap 164 can be frictionally coupled with a hollowed-out or stepped portion of the housing to be held in place on the housing when the device is not in use. In an exemplary embodiment, the distal 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 is assembled together, the first body portion 116 and the second body portion 118 form a tapered tubular structure. The lateral surfaces of the body portions 116, 118, abutting the gripping surfaces 173 on the proximal end end 172, may include one or more hollow or concave portions 122, 124. In an exemplary embodiment, two cupped portions 122, 124 may be provided at opposite ends of the device abutting the fire button 120. The cupped portions allow the user's hand to settle into a comfortable position when the button is depressed. Shooting

120.

A portion of the body portions, 116, 118, abutting the recessed portions 122, 124, may be overmoulded 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 can be provided on opposite lateral surfaces of the device. A first gripping surface 154 may abut a first hollow portion 122, and a second gripping surface 156 may abut a second hollow portion 124. Corresponding gaps 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 gripping region, a second overmolded gripping region, and a hollow region abutting the first and second overmolded regions can be provided. The first over-molded grip region, the second over-molded grip region and the recessed region can cooperatively provide an ergonomic and comfortable grip area in which a user can grip the automatic injection device to perform an injection.

In this exemplary embodiment, the first overmolded gripping region may be formed by proximal end end 172 having an overmolded outer surface or shell. The second overmolded gripping region may be formed as a part of the assembly of the first body portion 116 and the body 118 having one or more overmolded gripping surfaces (eg, gripping surfaces 154, 156). In an exemplary embodiment, the overmolded second grip region may have a substantially tapered tubular structure to provide an ergonomic fit with a user's hand. The hollow region adjoining the first and second overmolded grip region 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 grip region. and the second overmolded grip region. In an exemplary embodiment, the cupped region can be provided between the first and second overmolded gripping regions. In an exemplary embodiment, the hollow 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 (which extend 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 where the front surface is transformed into the side surfaces may be pointed, or smooth and rounded to maintain an aerodynamic shape of the device and for the device. The front and / or side surfaces of the first body portion 116 can 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. The skilled artisan 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 LH plane) and left and right side 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 an aerodynamic shape of the device and for ergonomic device handling. The front and / or side surfaces of the second body portion 118 can 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. The skilled artisan will recognize that other exemplary shapes are possible for the second body portion 118 of the device.

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

Preferably, an exemplary container 160 is slidably placed in cavity 102 and coupled with an injection needle (not shown) at a distal end. The injection needle can be covered with a needle guard, 162, for example, a soft needle guard and / or a rigid needle guard. 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 diverter members) that move the container from a covered position to a projected position. When the device is in a pre-injection state, container 160 may be in a covered position, i.e., retracted into the housing.

the device, the container advancement mechanism can advance container 160 to a projected position, such that the injection needle projects from a distal end of the housing to allow the therapeutic agent to be propelled into the patient's body. The distal end of the housing may include an opening through which the needle can project.

The cavity 102 within the housing can also accommodate a trigger coupling mechanism, for example the trigger button 120. The trigger button 120, when actuated by pressing, activates the container advance mechanism which, in turn, it advances container 160 toward the injection site, drives the injection needle toward the injection site, and delivers the therapeutic agent at the injection site. In an exemplary embodiment, at least a portion of the outer surface of the trigger button 120 may be overmoulded with one or more rubberized grip surfaces to facilitate pressing of the trigger 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 over-molded grip surface. In an exemplary embodiment, the gripping surfaces on the trigger button 120 can be made a different color from the non-gripping surfaces, to provide the visual possibility of indicating which area of ​​the device is to be gripped. For example, the grip surfaces on fire button 120 may be green, while all other surfaces on the device may be one or more colors other than green.

FIG. 3 shows that a front surface of the first body portion 116 can include a first opening 119, through which the firing button 120 can protrude out of the front surface. An exemplary aperture 119 may be circular to accommodate firing button 120 with a circular cross section, although other shapes are possible. The front surface of the first body portion 116 can include a second opening 127 to accommodate the transparent inspection window 128.

As illustrated in FIG. 3, in an exemplary embodiment, the removable distal cap 164 may be frictionally coupled to 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 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 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 gradually and slightly widens to a larger width (width w2) at the distal end of proximal terminal end 172. The proximal end of the first body portion 116 abutting the proximal terminal end 172 plus hollowed out 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 end end 172. At the distal end of the recessed portions 122, 124, the first body portion 116 can be widened to a larger width of the device (width W) and gradually tapered to a narrower width (width w4) near the middle portion Of the device. In the distal portion 104 of the device, the first body portion 116 can 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 distal cap 164 may include one or more protrusions 170a, 170b (shown in Figure 5) which extend outwardly from the front surface and rear surface of the dlstal cap 164 to further facilitate grasping of the distal cap.

The skilled artisan will recognize that other forms of the 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 through, the left lateral surface of the first body portion 116, and a right gripping surface 132 to partially cover, and extend through, the right lateral surface of the first portion "an exemplary embodiment, each gripping surface 130, 132 it can be arranged between the firing button 120 and the inspection window 128. The person skilled 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 through, the left lateral surface of the second body portion 118, and a right grip surface 153 may be provided to partially cover , and extend through, the right lateral surface of the second body portion 118. When the first and second body portions are assembled, the left grip surfaces 130, 152 can form a contiguous left grip surface 154 on the housing, and the right grip surfaces 132, 153 can form a right grip surface adjoining 156 on the accommodation. The adjoining left and right gripping surfaces 154, 156 facilitate the comfortable and reliable gripping and manipulation of the device by the hand of a user, which greatly and surprisingly improves the experience of physically weak users, for example, older users and users who have rheumatoid arthritis.

In user tests conducted 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 of the participants i had a strong preference for the handling and grip of 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 gripping surfaces were the main factor in participants' high scores for the example handling and gripping device. For various usage factors, there was a significant positive correlation between the Cochin scores and the example device of the present invention with the overmolded gripping surfaces, indicating that the example device of the present invention is well suited for users with hand dysfunction.

One of skill in the art will recognize that the left and right gripping surfaces can have different sizes, shapes, and configurations than the exemplary sizes, shapes, and configurations shown in Figures 1-8. The skilled artisan 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 of skill in the art will also recognize that one or more gripping surfaces can be placed in exemplary automatic injection devices at different positions from 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 round, smooth, aerodynamic configuration.

The overmolded gripping surfaces provided in the exemplary embodiments can be formed of any suitable material that provides a smooth, high-friction first feel to a user, compared to portions of the device that lack an overmolded gripping surface that provide a second perception of hard touch and low friction 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 grip surfaces over- molded.

In an exemplary embodiment, the overmolded gripping surfaces can be formed from a first type of material that has a smooth, high-friction feel to a user, while portions of the device that lack the overmolded gripping surfaces can be formed. forming of a second type of material that has a harder touch perception and low friction for 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, non-gripping 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 low friction, hard touch feel to the user. Rigid thermoplastics can include materials such as polypropylene (PP), polyethylene (PE), high impact polystyrene (HIPS), polycarbonate (PC), acrylonitrilobutadiene-styrene (ABS), poly (ethylene terephthalate) (PET), polyamide ( PA), PC / ABS mix, and PPO / PS mixes.

Exemplary overmolded gripping surfaces can be formed from materials having any suitable material grade and hardness to provide a smooth, high-friction feel to the user. Exemplary materials of the overmolded grip surface may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanization (TPV), etc. Exemplary thermoplastic elastomers that can be used to form 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 exemplary overmolded gripping surfaces include, without limitation, Santoprene ™ thermoplastic from

ExxonMobil, etc.

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

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

FIG. 6A is a close-up front view of an exemplary left overmolded gripping surface, 130, provided in a first body portion 116 of the device 100 of FIG. 1. FIG. 6B is a close-up view of the left side of the surface. exemplary left overmolded gripper 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 may be of structure and similar configuration.

Referring to Figures 6A and 6B, the left overmold 130 may have a first longitudinal side 134 that extends over the front surface of the first body portion 116 substantially along 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 first longitudinal side 134 can extend to, and connect to, io end 138 of a first horizontal side 140 of left overmoulded gripping surface 130. The first horizontal side 140 can 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 can 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 that extends to the first longitudinal side 134 at an angle with respect 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 length of the first horizontal side 140 can inc about 2: 1, 2.5: 1, 3: 1, 3.5: 1, 4: 1, 4.5: 1, 5: 1, all intermediate ratios etc.

A distal end 144 of the first longitudinal side 134 can extend to, and connect to, an end 146 of a second horizontal side 148 of the left overmolded gripping surface 130. In an exemplary embodiment, a connection side 150 extending between ends 144, 146, may connect first longitudinal side 134 to second horizontal side 148. In an exemplary embodiment, connection side 150 may be longer than connection side 142. In exemplary embodiments, a ratio of connection side length 150 to connection side length 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 relationships, etc., but is not limited to these exemplary relationships. The second horizontal side 148 can 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, 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, 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 relationships intermediate, etc., but is not limited to these exemplary relationships.

Fig. 7 is a bottom view of an exemplary removable distal cap 164 showing the overmolded gripping surface 165. The overmolded gripping surfaces 165 can be formed of any suitable material that first provides smooth, high friction touch perception. for a user, compared to portions of the device that lack an over-molded grip surface that provides a hard, low-friction feel for 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 overmolded grip surfaces.

In an exemplary embodiment, the overmolded gripping surfaces can be formed from a first type of material that has a high friction soft touch perception, while the non-gripping surfaces are formed from a second type of material that has a low-friction hard touch perception. Exemplary overmolded gripping surfaces 165 can be formed of materials having any suitable material grade and hardness to provide a high friction soft touch perception for the user. Exemplary materials of the overmolded grip surface may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanization (TPV), etc. Exemplary thermoplastic elastomers that can be used to form exemplary limiting overmolded gripping surfaces, TRAs from KRAIBURG, TPE Dynaflex ™ from PoIyOne, TPE Versaflex ™ from PoIyOne, TPE Versollan ™ from PoIyOne, etc. Exemplary thermoplastic vulcanizates that can be used to form exemplary overmolded gripping surfaces include, without limitation, ExxonMobil Santoprene ™ thermoplastic, etc. In an exemplary embodiment, the overmolded gripping surfaces 165 can be made a different color from the non-gripping surfaces, to provide the visual possibility of indicating which area of ​​the device is to be gripped. For example, the overmolded gripping surfaces 165 on the distal cap 164 may be brown, while the non-gripping surfaces of the housing may be gray.

Figure 8 is a top view of an exemplary proximal end end 172 for covering the proximal end of the housing. In an exemplary embodiment, the outer surface of proximal end end 172 may lack any overmolded gripping surface. 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 the proximal end end 172 may be covered by an overmolded gripping surface 173.

Overmolded gripping surfaces 173 can be formed of any suitable material that provides a smooth and high friction first touch perception for a user, in c portions of the device that lack an over molded gripping surface that provides a second soft touch perception and low friction for one 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 grip surfaces overmolded.

In an exemplary embodiment, the overmolded gripping surfaces 173 can be formed from a first type of material that has a high friction soft touch perception, while the non-gripping surfaces are formed from a second type of material that has tougher low-friction touch perception. Exemplary overmolded gripping surfaces 173 can be formed of materials having any suitable material grade and hardness to provide a high friction soft touch perception for the user. Exemplary materials of the overmolded gripping surface may include, without limitation, rubber (eg, having a durometer value of 50A in one embodiment), thermoplastic elastomers (TPEs), thermoplastic vulcanizing (POS), etc. Exemplary thermoplastic elastomers that can be used to form 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 exemplary overmolded gripping surfaces include, without limitation, ExxonMobil 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 possibility of

Indicate which area of ​​the device should be grasped. For example, the overmolded gripping surfaces 173 on the proximal end end 172 may be brown, while the non-gripping surfaces of the housing may be gray.

In an exemplary embodiment, one or more flanges (projecting from the outer surface) and / or one or more grooves or holes (which are sunk toward the outer surface) may be provided on the outer surface of the proximal end end 172, to facilitate plus the grip of the proximal portion of the device. The shapes and locations of the flanges and / or grooves can be altered at will and any desired number of flanges 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 hollow 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 hollowed surface 176 can accommodate a finger on the surface

176 while the user makes an injection using the device.

In some exemplary embodiments, removable distal housing 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 can have any suitable graphic, symbol and / or number to facilitate instruction to the patient, or the automatic injection device can omit said 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, an automatic injection device housing can be provided in two or more separate housing components (eg, first and second body portions), which can be coupled together during device assembly.

In step 902 a first portion of the housing is provided or formed. In step 904, one or more gripping surfaces are overmoulded over corresponding recesses in the outer 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 one or more gripping surfaces are overmolded, corresponding on the outer surface of the second body portion, to facilitate gripping and manipulation 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 overmoulded over corresponding recesses in the outer surface of the proximal terminal end, to facilitate gripping and manipulation of the device.

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

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

In step 922, one or more internal components of the automatic injection device can 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 injection into a patient, an injection needle attached to a distal end of the container, a container advancement mechanism for making advance the container into the housing

<img file="MX360402B_D0009.tif" />

oo

oh »same to the injection site and to propel the therapeutic agent from the container during an injection, a trigger button to activate the container advance mechanism, etc.

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

In step 926, the removed distal cap can be removably attached to a distal end of the body assembly to cover an injection needle or a needle guard which, in turn, covers the injection needle.

In step 928, the proximal terminal end can be attached to 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 is to be noted that the order of the steps set forth herein can be altered at will, and that other steps / manufacturing techniques are possible and are considered within the spirit and spirit of the invention.

Automatic injection device user tests

Forty-four participants were recruited for the test, to test both the exemplary automatic injection devices of the present invention having overmolded gripping surfaces, and four alternate 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 from 1 to 40 years earlier, with an average diagnosis time 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 a phase of using the exemplary device, each participant performed a sham injection (i.e., an injection with cut-off needles and no 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, overall user experience, etc.

Device handling and grip

After performing sham injections using the different device configurations, participants were asked to provide feedback and comparative scores on handling and grip, 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 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 do not include overmolded gripping surfaces. Participants particularly preferred the overmolded rubber grips on the side of the exemplary device and its relatively large size, which makes it easy and comfortable to hold the exemplary device. Rubber overmolded grips were the primary factor in the high scores participants gave to the exemplary handling and grip device configuration, as taught herein.

In addition, a correlation analysis was performed on hand dysfunction using the Cochin hand disability scale with the scores provided for some use factors: handling and grip, ease of use, ease of starting and performing an injection, comfort at perform an injection, acceptance and general performance. For various usage factors there was a significant positive correlation between Cochin scores and the configuration of the exemplary device of the present invention, indicating that the exemplary device is highly suitable for users with hand dysfunction.

Comfort of holding and using the device

By performing simulated injections in the exemplary device use phase, test participants were asked to rate comfort by 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 configuration of the exemplary device of the present invention for its comfort when performing the injection steps, 45% giving the highest rating.

Ease of use and handling of the device

After initial exposure to the exemplary device and before 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 not including overmolded gripping surfaces. Participants rated each device configuration on a scale of 1 (very difficult) to 7 (very easy). All device configurations received high scores for perceived ease of use.

After performing simulated injections in the actual device use phase, 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). Furthermore, after performing the simulated injections using the device configuration in the third phase of use of the actual device, participants were also asked to rate the configuration on its general usability on a scale of 1 (very difficult) to 10 ( very easy).

Most of the participants (42%) found that the exemplary device configuration of the present invention is 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 exemplary device use phase, test participants were asked to rate the overall size of the exemplary device configuration of this invention and four alternate device configurations that do not include overmolded gripping surfaces, on a scale of 1 (very low confidence) to 7 (very high confidence). Overall, all device configurations received positive scores for

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<img file="MX360402B_D0010.tif" />

its general shape. In general, participants who formed a tight fist preferred 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 this invention and four alternate device configurations that do not include overmolded gripping surfaces, on a scale of 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 snug fist preferred larger devices. Regarding the configuration of the exemplary device of the present invention, many participants found that the shape fits nicely in their hand.

III. Incorporation by reference

The content of all references, including patents and patent applications cited throughout this application, is incorporated herein by reference in its entirety. The appropriate components and methods of those references can be selected for the invention and the embodiments thereof. In addition, the comj

Identified in the Background section are integral to this disclosure and can be used in conjunction with, or substitute for, the components and methods described anywhere in the disclosure within the scope of the invention.

IV. Equivalents

When describing exemplary modalities, specific terminology is used for clarity. For descriptive purposes, each specific term is intended to at least include all technical and functional equivalents that operate similarly 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 specifying parameters for various properties in exemplary modes, the parameters can be adjusted up or down by a twentieth, a tenth, a fifth, a third, a 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 without departing from the scope of the invention. Further 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. The skilled artisan will recognize that exemplary methods may include more or fewer steps than those illustrated in exemplary flowcharts, and that steps in exemplary flowcharts can be performed in a different order than shown.