Injector.

(54) Title: INJECTOR. (54) Title: INJECTOR.

(57) Summary

An injector is described that includes a syringe accommodated along an axial axis, a removable cover for removable coupling with the syringe and a cover removal assembly that includes an external portion that is engageable by a user and is axially movable in a direction of disengagement of the cover along an axial travel path with relative to the longitudinal axis and an internal portion that includes at least one coupling portion that is engageable with the removable cover, whereby axial movement of the inner portion in the direction of disengagement of the cover removes the removable cover from the syringe, at least one of the outer portion and the inner portion is configured such as to provide an axially floating lost motion coupling between the outer portion and the inner portion.

(57) Abstract

An injector including a syringe arranged along a longitudinal axis, a removable cover for removable engagement with the syringe and a cover removal assembly including an outer portion which is engagable by a user and is movable axially in a cover disengagement direction along an axial travel path with respect to the longitudinal axis and an inner portion which ineludes at least one engagement portion which is engagable with the removable cover, whereby axial movement of the inner portion in the cover disengagement direction removes the removable cover from the syringe, at least one of the outer portion and the inner portion being configured such as to provide an axially floating lost motion engagement between the outer portion and the inner portion.

I KNOW

Αίββίΐ *** · »secwtama» »imwwíÁ

Headlines):

Home:

Institute

Mexican Property

Industrial

PATENT TITLE NO. 336571

ELCAM MEDICAL AGRICULTURAL COOPERATIVE ASSOCIATION LTD.

Kibbutz Bar-Am, 13860, ISRAEL

Denomination: INJECTOR. Classification: IC 8: A61M5 / 20

<img file="MX336571B_D0001.tif" />

<img file="MX336571B_D0002.tif" />

fractions lll and 7 ° bis 2 of IsS-ey of the Federation (DOF) 06/27/1991, amended on 08/02/1994, 10/25/1996, 12/26/1997, -f / 05/1999, dustrial ration.

Twenty unprofitable years, before subsections a), 4th and 12th fractions I and lll of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, amended on 07/01/2002, 07/15/19 2004, 07/28/2004 and 09/07/2007); Articles 1, 3, 4, 5, section V, subsection a), 16 sections I and lll and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 27/12 / 19Θ9, amended on 10/10/2002 , 07/29/2004, 08/04/2004 and 09/13/2007); 1st. 3rd and 5th subsection a) of the Agreement that delegates powers to the Deputy Directors General, Coordinator, Divisional Directors, Holders 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).

<img file="MX336571B_D0003.tif" />

Issue Date: January 25, 2016

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

<img file="MX336571B_D0004.tif" />

Arenal No, 650, Floor 1_;

Coi. Pueblo Santa María Tepepan,

Xochimilco Delegation,

CP 15020, Mexico City

Tea! (55) 53 34 0/00 www iropi cob.mx

MX / 2016/6187

3%5?\

4y | / i l20). | Oo € 6? L

INJECTOR

IMPI

Mexican Institute of Industrial Property

<img file="MX336571B_D0005.tif" />

Field of the Invention

The present invention relates to injectors in general.

Background of the Invention

The following patent publications are believed to represent the current state of the art:

United States Patent No. 7,597,685;

United States Patent Publications Nos.

2007/0156088; 2008/0009789; 2008/0249477 and 2010/0137810; and

International Publications Nos. W02008 / 029280 and

W02009 / 040601.

Brief Description of the Invention

<td></td><td>The</td><td>Present</td><td>invention</td><td>seeks to provide</td><td>a</td>

<td>injector</td><td colspan="2">improved.</td><td></td><td></td><td></td>

<td></td><td>I know</td><td>provides</td><td>of this</td><td>mode according to</td><td>a</td>

<td>modality</td><td colspan="2">preferred of the</td><td>Present</td><td>invention an injector</td><td>than</td>

<td>It includes</td><td>a</td><td colspan="2">syringe accommodated</td><td>throughout a</td><td>axis</td>

<td colspan="2">longitudinal,</td><td colspan="4">a removable cover for coupling</td>

<td>removable</td><td>with</td><td>The syringe</td><td colspan="3">and a cover removal mount</td>

including an external portion that is user attachable and is axially movable in a cover disengagement direction along an axial travel path with respect to the longitudinal axis and a portion

Ref. 242850

<img file="MX336571B_D0006.tif" />

INSTITUTE Me J

DE internal PH including at least one coupling portion which is engageable with the removable cover, whereby axial movement of the internal portion in the direction of disengagement of the cover removes the removable cover from the syringe, at least one of the outer portion and the inner portion is configured such as to provide an axially floating lost motion coupling between the outer portion and the inner portion, whereby axial movement of the outer portion in the cover decoupling direction produces corresponding axial movement of the inner portion in the cover decoupling direction along at least a portion of the axial travel path, the length of the axial travel portion is a function of the relative axial positioning of the removable cover and the syringe.

Also provided, in accordance with a preferred embodiment of the present invention, is an injector including a syringe accommodated along a longitudinal axis, a removable cover for removable coupling with the syringe, and a cover removal assembly including a portion external which is user attachable, and is axially movable in a cover disengagement direction along an axial travel path with respect to the longitudinal axis, and an inner portion that includes at least one coupling portion that

<img file="MX336571B_D0007.tif" />

It is engageable with the removable cover, whereby axial movement of the inner portion in the direction of cover disengagement removes the removable cover from the syringe, the inner portion is configured such as to limit the position of at least one coupling portion with relative to the removable cover in a direction opposite to the cover decoupling direction after mutual decoupling of the inner portion and the removable cover.

In accordance with a preferred embodiment of the present invention at least one of the outer portion and the inner portion is configured such as to provide an axially floating lost motion coupling between the outer portion and the inner portion, whereby variations in the axially relative positioning of the removable cap and syringe and / or relative in the axial positioning of the cap and syringe with respect to one or more other parts of the injector such as the housing are taken into account, whereby the axial movement of the outer portion in the cover decoupling direction produces the corresponding axial movement of the inner portion in the cover decoupling direction along at least a portion of the axial travel path, the length of the portion of the axial travel path that is a function of the positioning

<img file="MX336571B_D0008.tif" />

A further feature of an embodiment of the present invention is that axially floating motion can be advantageous in cases where the device is accidentally dropped onto the outer portion. The previously described axially floating motion coupling between the outer portion and the inner portion can prevent transmission of the resulting impact to the syringe, and therefore preserves its integrity.

Preferably, at least one coupling portion is positionable between the removable cover and a portion of the syringe lying rearwardly thereof.

In accordance with a preferred embodiment of the present invention, the axially floating lost motion coupling between the outer portion and the inner portion accommodates variations in the axially relative positioning of the cover and syringe. Preferably, the axially floating lost motion coupling between the outer portion and the inner portion accommodates manufacturing tolerances and variations in axially relative positioning of the multiple parts of the injector.

Preferably, the inner portion is configured such as to limit the position of at least one

<img file="MX336571B_D0009.tif" />

<img file="MX336571B_D0010.tif" />

coupling portion relative to the '' UUbiértci '' itíiiitivible in a direction opposite to the cover decoupling direction after mutual coupling of the inner portion and the removable cover.

Also provided in accordance with another preferred embodiment of the present invention, is an injector that includes a syringe accommodated along a longitudinal axis, a removable cover for removable coupling with the syringe, and a cover remover that includes at least a portion coupling that is engageable with the removable cover, whereby the axial movement of the cover remover in a cover decoupling direction, removes the removable cover from the syringe, the cover remover is configured such as to limit the position of at least one coupling portion relative to the removable cover in a direction opposite to the cover disengagement direction after mutual coupling of the oar cover vedor and removable cover. This structure may be advantageous, for example, in cases where the cover remover is made of plastic material and the slow advancement of at least one coupling portion may otherwise occur during storage of the device, thereby possibly reducing reliability. removal of the removable cover.

Preferably, the syringe includes a needle.

IMPI

MEXICAN INSTITUTE OF THE FRC'PIi-DAD INDUSTRIAL

<img file="MX336571B_D0011.tif" />

fixedly mounted on it. Also, the remoVlblt cover? Includes a removable needle cover that covers the needle. Preferably, the removable needle cover includes a relatively rigid outer portion and a relatively elastic inner portion.

Brief Description of the Figures

The present invention will be more fully appreciated from the following detailed description, taken in conjunction with the figures in which:

FIG. 1 is a simplified exploded view illustrating an injector constructed and operative in accordance with a preferred embodiment of the present invention;

Figures 2A and 2B are respective simplified assembled respective top and side views of the injector of Figure 1 in an operational orientation prior to use;

Figure 2C is a simplified sectional illustration of the injector of Figures 2A and 2B, taken along lines IIC-IIC in Figure 2B;

Figures 3A, 3B, 3C and 3D are, respectively, a simplified pictorial illustration of an internal portion of a cover removal assembly forming part of the injector of Figures 1-2C, a simplified top view of the internal portion, a simplified side view of the inner portion and a simplified sectional illustration taken along the lines IIID-IIID in Figure 3C;

<img file="MX336571B_D0012.tif" />

Figures 4A, 4B, 4C and 4D are 7 — w «npn? Hvaniente. a simplified pictorial illustration of an outer portion of a cover removal assembly forming part of the injector of Figures 1-2C, a simplified side view of the outer portion, a simplified extreme view of the outer portion, and a simplified sectional illustration taken along the IVD-IVD lines in Figure 4B;

Figure 4E is a simplified partially cutaway pictorial illustration of the outer portion shown in Figures 4A-4D;

Figures 5A and 5B are, respectively, a simplified side view pictorial illustration of the injector of Figures 1-2C and a simplified sectional illustration, taken along the lines VB-VB in Figure 5A, of the inner and external of the cover removal assembly assembled, assembled to the injector in a typical pre-use operational orientation;

Figures 6A-6D are simplified sectional illustrations of the inner and outer portions of the injector-assembled cover removal assembly, in four stages of cover removal for a shorter syringe length and typically more rearward cover position;

Figures 7A-7D are simplified sectional illustrations of the inner and outer portions of the injector assembled cover removal assembly, in four

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY cover removal stages for a longer syringe length and a typically more backward cover position;

Figures 8A-8D are simplified sectional illustrations of the inner and outer portions of the injector-mounted cover removal assembly, in four stages of cover removal for a shorter syringe length and a typically more forward cover position;

Figure 9 is a simplified illustration of a complete cover decoupling from the injector; and

Figures 10A, 10B and 10C are, respectively, simplified illustrations in top and side view of the injector of Figure 9 following the complete cover decoupling from the injector, and a simplified sectional illustration of the injector of Figures 9-10B, taken at along the XC-XC lines in Figure 10B.

Detailed description of the invention

Reference is now made to Figure 1, which is a simplified exploded view of an injector 1000 constructed and operative in accordance with a preferred embodiment of the present invention, to Figures 2A and 2B, which are a top and side view respective, simplified, assembled illustrations of the injector of Figure 1 in an operational orientation before use, and to the

<img file="MX336571B_D0013.tif" />

IMPI

INSTI1 MEXICAN UTO OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0014.tif" />

Figure 2C, which is a simplified sectional illustration? of the injector of Figures 2A and 2B, taken along the lines IIC-IIC in Figure 2B. Injector 100.0 generally extends along an axis 1010.

The injector 1000 comprises a needle protection element 1030, which is placed by a compression spring 1032 within a leading end of a leading housing 1034, having a leading edge 1036. The leading housing 1034 is operative to engage, in a front end thereof, a cover removal assembly 1038, including an outer portion 1039 and an inner portion 1040.

A syringe 1041, including a rear flange 1042 and a front face surface 1043 and having a hypodermic needle 1044 fixedly mounted thereon, the needle of which is covered by a removable needle cover 1045, such as a rigid needle guard (RNS ,) is operatively coupled by a plunger 1046 accommodated for axial movement along axis 1010. The removable needle cover 1045 preferably includes a relatively rigid outer portion 1047 and a relatively elastic inner portion 1048. The relatively rigid outer portion 1047 is formed with a circumferential trailing edge 1049 and a front surface 1050 having an opening 1051. The syringe 1041 and the plunger 1046

IMPI

V Mexican INSTITUTE

PROPERTY t

INDUS ERIAL

<img file="MX336571B_D0015.tif" />

they are preferably located within front housing 1034. Syringe 1041 may be a conventional syringe, such as a commercially available syringe sold under the catalog designation BD-Hypak^MR or it can be any other suitable syringe or cartridge. It is appreciated that the length of conventional syringes typically varies within manufacturing tolerances of +/- 0.5mm. It is also appreciated that the axial position of the removable needle cover 1045 relative to the rear flange 1042 typically varies within the manufacturing tolerances of +/- 1.3 mm. Various other manufacturing tolerances, which may affect the axial position of the removable needle cover 1045 relative to the front housing 1034, may accumulate to a total of +/- 1.1 mm. It is appreciated that the aforementioned tolerances are merely exemplary in that other syringes may have different tolerances.

Plunger 1046 selectively mates with a selectable drive assembly 1057, which includes a selectable drive element 1058 and a pair of elastomeric motion damping elements 1059. The selectable drive assembly 1057 is preferably at least partially seated within a rear housing 1060, in front of a main compression spring 1062, also seated inside the

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0016.tif" />

rear housing 1060. Primary compression spring 1062 provides selectable front axial displacement to selectable drive assembly 1057. Selectable operation of plunger 1046 by selectable drive assembly 1057 causes plunger 1046 to inject the liquid contents of syringe 1041 through of the hypodermic needle 1044.

The rear housing 1060 has associated therewith a drive button 1070, operative to selectively drive the operation of the selectable drive assembly 1057. Inside rear housing 1060 are seated a rear end element 1080, operative to seal the rear end of rear housing 1060, and a plunger lock member 1090, cooperative with rear end element 1080 and operative to secure piston 1046 when the contents Liquids from the 1041 syringe should not be injected through the 1044 needle.

Reference is now made to Figures 3A, 3B, 3C, and 3D, which are, respectively, a simplified pictorial illustration of an internal portion of a cover removal assembly that is part of the injector of Figures 1-2C, a view simplified top of the inner portion, a simplified side view of the inner portion, and a simplified sectional illustration taken along the lines IIID-IIID in Figure 3C.

<img file="MX336571B_D0017.tif" />

msxÍgano institute

OF INDUSTRIAL PROPERTY

Inner portion 1040 is preferably formed as a one-piece, unit injection molded element, and includes a generally circular cylindrical base portion 1100 having a rear facing surface 1101. Alternatively, inner portion 1040 may be assembled multi-part. From a respective opposing face sites 1102 and 1104 on an outer surface 1106 thereof, a pair of mutually facing identical flexible arms 1110 extend. Arms 1110 generally extend axially parallel to a longitudinal axis lili.

Each arm 1110 includes a pair of axially mutually spaced base portions 1112 which extend outwardly and axially from base portion 1100, a main arm portion 1114, a narrowed portion 1116, and an end portion 1118. Each end portion 1118 preferably includes a mating portion, preferably in the form of a pair of internal front teeth 1120, each having a tapered back face surface 1122 and an oppositely tapered forward face surface 1124. Facing each of the surfaces 1124 is a corresponding inwardly tapered, backward-facing end surface 1125 of the main arm portion 1114 on each side of the narrowed portion 1116. Each portion

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0018.tif" />

End 1118 also includes respectively inward and outwardly tapered inner and outer face back ends 1126 and 1128, respectively.

Base portion 1100 preferably includes a pair of axial grooves 1130 which extend forward from an axially rear end thereof of intermediate arms 1110.

A pair of inward facing teeth 1132 are positioned inward and outward of the cylindrical base portion 1100 intermediate each pair of axial base portions 1112. Each of the teeth 1132 has an inward facing surface and radially forward, tapering forward 1134 and a rearward facing surface 1136 that is generally perpendicular to the lili axis. The teeth 1132 are each preferably supported on a bridge portion 1138 which lies outward and forward of the cylindrical base portion 1110, bridging each pair of axial base portions 1112 forward.

Reference is now made to Figures 4A, 4B, 4C, and 4D, which are, respectively, a simplified pictorial illustration of the outer portion 1039 of the cover removal assembly 1038 that is part of the injector 1000 of Figures 1-2C, a simplified side view of the outer portion 1039, a simplified outer view of the portion

IMPI »»

MEXICAN INSTITUTE

FROM OWNERSHIP 'external 1039 and a simplified sectional illustration rSrmt along lines IVD-IVD in Figure 4tí, —tar

Figure 4E, which is a simplified, cutaway, pictorial illustration of the outer portion shown in Figures 4A-4D.

As seen in Figures 4A-4E, the outer portion 1039 is in the form of a generally cylindrical cap having a generally cylindrical overall shape with a partially flattened circular cross section perpendicular to an axis 1200. As seen in Figures 4A-4E, outer portion 1039 includes a base 1201, a pair of edge surfaces 1202, each having an arrangement of grip enhancement protuberances 1204, and a pair of side surfaces 1206, each having a cutout 1208 generally square, facing backwards, formed therein. Base 1201 has a forward facing surface

1209.

Base 1201 is preferably formed with a central opening 1210 communicating with the interior of a cylindrical, generally tubular, back-facing tubular portion 1212. Tubular portion 1212 has a tapered rear-facing end surface 1216 and includes a pair of axially extending, mutually circumferentially spaced protuberances 1218, as well as a pair of mutually circumferentially extending recesses 1220

15'

MEXIC »INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX336571B_D0019.tif" />

spaced, generally evenly spaced between protuberances 1218. Holes 1220 each include a forward-facing circumferential surface 1221 that is generally perpendicular to axis 1200.

Base 1201 is formed with a pair of arcuate openings 1222 each of which communicates with a corresponding recess 1220 and with the interior of outer portion 1039 outside of tubular portion 1212.

The needle protection element 1030 is preferably identical to that shown in Figures 6567B of the PCT Published Patent Application WO

2008/047372 and described herein. The description of the

PCT Published Patent Application WO 2008/047372 is hereby incorporated by reference.

As described in detail in the Request for

PCT Published Patent WO 2008/047372, the needle protection element 1030 includes a pair of restriction elements, which prevent actuation of the device when a user presses actuation button 1070 when the device is not pressed against the body of the user. A cylindrical portion having a front end including a generally circular hole, through which the needle passes during drug injection is provided at a front portion of the needle shield member 1030. After the 'IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0020.tif" />

injection, the cylindrical portion is lazade — 4 »eíiu — ajdeJ ^ LlxLa. relative to the needle, thereby covering the needle and preventing accidental needle bites.

Front housing 1034 is preferably identical to that shown in Figures 68-7OC of PCT Published Patent Application WO 2008/047372 and described herein. The description of PCT Published Patent Application WO 2008/047372 is incorporated by reference herein.

As described in detail in the Request for

PCT Published Patent WO 2008/047372, front housing 1034 includes at a rear end thereof a cutout portion 1402 adapted to accommodate actuation button 1070.

As seen in Figure 1, plunger 104 6 includes a threaded boss 1470, which threadably engages a corresponding threaded plug (not shown) formed on a posterior surface of the piston of syringe 1043. To the rear of the threaded boss 1470 is a generally circular cylindrical portion 1472 having a first transverse sectional radius, followed by a relatively short circular cylindrical portion 1474 having a second transverse sectional radius greater than the first radius and defining a shoulder of face back 1475.

Behind portion 1474 is a third

IMPI

MEXICAN INSTITUTE DB INDUSTRIAL PROPERTY cylindrical portion in general circular 1476 that has a third transverse sectional radius, generally equal to the first radius. To the rear of portion 1476 is a toothed portion 1477 formed, each tooth thereof having a generally transverse forward facing portion and a sloping rearward facing portion. The particular shape of the teeth of the toothed portion 1477 enables backward movement of the plunger 1046 at any time, and requires a specific configuration of the device in order to enable forward movement of the plunger 1046.

Plunger 1046 is preferably symmetrically positioned about a longitudinal axis.

The selectable drive assembly 1057 is preferably identical to that shown in Figures 7173B of PCT Published Patent Application WO

2008/047372 and described herein. The description of PCT Published Patent Application WO 2008/047372 is incorporated by reference herein.

As described in detail in Request for

PCT Published Patent WO 2008/047372, the selectable drive assembly 1057 includes a selectable drive element 1058 and the elastomeric motion damping elements 1059. The selectable drive element 1058 includes a generally cylindrical, rear-facing portion and a pair of arms

<img file="MX336571B_D0021.tif" />

IMPI

<img file="MX336571B_D0022.tif" />

longitudinal. At a front end of the bay one of the __ longitudinal arms provides a hinged first finger, which has formed on it a pair of protrusions facing inward. The inward-facing protuberances are adapted to engage the flange 1042 of the syringe 1041 to retain it in position prior to actuation of the injector and to control its forward movement during actuation thereof.

Backwardly facing the first hinged finger on each of the longitudinal arms is a second hinged finger, which has an inward-facing protrusion, which is adapted to move backward on the 1041 syringe after injection, when the Needle guard 1030 is shifted backwards.

Generally along and parallel to the second hinged fingers third hinged fingers are formed, each including an inclined face-in protrusion operative to displace plunger 1046 during injection, and a pair of protrusion face-out protrusions, which are operative to flex inward the hinged third fingers during actuation, and that they couple the needle protection element 1030 and are operative to move it forward as soon as the injector disengages from the body of the i KJAL

<img file="MX336571B_D0023.tif" />

user.

A cylindrical portion of the selectable drive assembly 1057 includes protrusions on opposite sides thereof, which are adapted to hold the selectable drive assembly 1057 in place, when the injector is in its storage position, when bumped against the drive button 1070. The cylindrical portion also has seated therein the motion damping elements 1059 which engage an internal surface of the rear housing 1060, and are thereby operative to retard forward movement of the selectable drive assembly 1057, whereby retards forward movement of syringe 1041 and plunger 1046 during injection.

The rear housing 1060 is preferably identical to that shown in Figures 74-76C of PCT Published Patent Application WO 2008/047372 and described herein. The description of PCT Published Patent Application WO 2008/047372 is incorporated by reference herein.

As described in detail in the Request for

PCT Published Patent WO 2008/047372, the rear housing 1060 is preferably an integrally formed element, preferably injection molded from plastic, and preferably has a general configuration

IMP

Mexican Institute of Industrial Property

<img file="MX336571B_D0024.tif" />

cylindrical arranged around an axis ítiigiLuri-i nr¹ The rear housing 1060 includes a tube, which includes a front portion having an inward facing surface that includes four longitudinally extending guide ribs, generally equally spaced. Also formed on the inward facing surface are a pair of inward facing protuberances whose width tapers in a forward facing direction, up to a point, thereby defining a generally triangular engagement surface for the damping elements. elastomeric movement 1059. Placed adjacent the wide end of each of the protuberances are an inclined recess and a cylindrical recess, which serve to guide the elastomeric damping elements 1059 upwardly from their engagement with the protrusions.

Formed on a pair of generally equally spaced external face surfaces of the tube are respective protruding outward structures, generally rectangular. The additional protuberances are located internally of the respective structures and are centered adjacent posterior ends thereof. These protrusions are accommodated in snap fit coupling plugs of the front housing 1034 during factory assembly of the device, and with

IMPI

INSTITUTO MEXICANO DELA PROPERTY INDUSTRIAL this maintains the connection between the rear housing 1060 and the front housing 1034. Formed in the tube adjacent to a rear end of it are a pair of side cutouts, each having a lowered front edge. Placed forward from each edge is a protrusion facing outward, generally rectangular.

The actuator button 1070 is preferably identical to that shown in Figures 77A-79B of PCT Published Patent Application WO 2008/047372 and described herein. The description of PCT Published Patent Application WO 2008/047372 is incorporated by reference herein.

The rear end element 1080 is preferably identical to that shown in Figures 8385C of the PCT Published Patent Application WO

<img file="MX336571B_D0025.tif" />

<td>2008/047372 and described</td><td>at the moment.</td><td>The description</td><td>of</td>

<td colspan="2">PCT Published Patent Application</td><td>WO 2008/047372</td><td>I know</td>

<td>incorporates by reference</td><td>at the moment.</td><td></td><td></td>

<td colspan="2">The element of assurance</td><td>piston 1090</td><td>is</td>

<td>preferably identical</td><td>to that one shown</td><td>in the figures</td><td> 80-</td>

<td>82B of the Request</td><td colspan="2">of the PCT Published Patent</td><td>wo</td>

<td>2008/047372 and described</td><td>at the moment.</td><td>The description</td><td>of</td>

<td colspan="2">PCT Published Patent Application</td><td>WO 2008/047372</td><td>I know</td>

incorporated by reference herein.

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

Various additional steps of typical use of the injector of Figures 1-2C are illustrated in Figures 86E-86L of PCT Published Patent Application WO 2008/047372 and described herein. The description of PCT Published Patent Application WO 2008/047372 is incorporated by reference herein.

Reference is now made to Figures 5A and 5B, which are, respectively, a simplified side view pictorial illustration of the injector of Figures 1-2C and a simplified sectional illustration of the inner and outer portions of the cover removal assembly, assembled to the injector in a typical operational orientation prior to use, relative to syringe 1041, needle 1044, and removable needle cover 1045. It is a particular feature of the present invention that the structure that will now be described in detail with reference to Figure 5B results in the reliable removal of needle cover 1045, notwithstanding the cumulative manufacturing tolerances described above in relation to the various portions of the injector.

The illustration in Figure 5B shows syringe 1041 having a length along the lili axis, which is within its manufacturing tolerances as described hereinabove, but not at either end thereof. Similarly, the illustration in Figure 5B

<img file="MX336571B_D0026.tif" />

1045 along the axis lili in a position relative to the syringe 1041 that is within its manufacturing tolerances as described herein above, but not at either end thereof.

As seen in Figure 5B, when the injector is in typical pre-use operational orientation, the forward facing surface 1043 is placed along the lili axis in front of and at a typical 7.5mm clearance from the leading edge 1036 of the front housing 1034. The rear facing edge 104 9 of the relatively rigid outer portion 1047 of the removable needle cover 1045 is positioned along the lili axis in front of and at a typical 8.8 mm clearance from the front edge 1036 of the front housing 1034.

The rear facing surface 1101 of the inner portion 1040 lies up against the forward facing surface 1050 of the relatively rigid outer portion 1047 of the removable needle cover 1045 and is positioned along the lili axis rearward of and at a typical 9.4 mm spacing of forward facing surface 1209 from base 1201 of outer portion 1039. The forward facing surface 1209 of the base 1201 of the outer portion 1039 is placed along the lili axis in front of and at a typical 44.6 mm spacing from the

<img file="MX336571B_D0027.tif" />

INSTiTU '

Γ *&gt; P ι. · - £ E tA PRÚHCn_TO3 FEATURE Front edge 1036 of front housing 1034.

The cylindrical base portion 1100 of the inner portion 1040 partially overlaps the generally circular cylindrical rear-facing tubular portion 1212 of the outer portion 1039, in axially sliding relation thereto, with the protrusions 1218 (not shown) of the outer portion 1039 lying in axial sliding engagement with corresponding axial grooves 1130 of inner portion 1040. The teeth 1132 of the inner portion 1040 lie in axial sliding engagement with the corresponding recesses 1220 of the outer portion 1039.

It is noted that each tooth 1120 of the inner portion 1040 lies immediately behind and in engagement with the rear facing edge 1049 of the removable needle cover 1045. It is also noted that the forward facing circumferential surface 1221 of the outer portion 1039 it lies rearwardly of and is spaced from the rearward facing surfaces 1136 of the teeth 1132 of the inner portion 1040.

Reference is now made to Figures 6A-6D, which are simplified sectional illustrations of the inner and outer portions of the injector-mounted cover removal assembly, in four stages of cover removal for a shorter syringe length and a cover position typically further back.

<img file="MX336571B_D0028.tif" />

<img file="MX336571B_D0029.tif" />

<img file="MX336571B_D0030.tif" />

Figure 6A shows the syringe, length along the lili axis, which is the shortest possible length that is within its manufacturing tolerances, as previously described herein. Similarly, Figure 6A shows the axial placement of the removable needle cover 1045 along the lili axis in the most rearward position relative to syringe 1041 that is within its manufacturing tolerances, as described above in the present.

As seen in Figure 6A, when the injector is in a typical pre-use operational orientation, the forward-facing surface 1043 is positioned along the lili axis in front of and a typical 4.8 mm clearance from the leading edge 1036 of the front housing 1034. The rearward facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle cover 1045 is positioned along the lili axis in front of and at a typical spacing of 5.4 mm from the front edge 1036 of the front housing 1034.

The rear facing surface 1101 of the inner portion 1040 lies up against the forward facing surface 1050 of a relatively stiff outer portion 1047 of the removable needle cover 1045 and is positioned along the lili axis in a backward direction. already a typical 12.8 mm spacing from the

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0031.tif" />

Forward facing surface 1209 of base 1201 of outer portion 1039. Forward facing surface 1209 of base 1201 of outer portion 1039 is positioned along the lili axis in front of and at a typical 44.6mm spacing of the front edge 1036 of the front housing

1034.

The cylindrical base portion 1100 of the inner portion 1040 partially overlaps the generally circular cylindrical rear-facing tubular portion 1212 of the outer portion 1039, in axial sliding relation thereto, with the protrusions 1218 (not shown) of the outer portion 1039 lying in axial sliding engagement with corresponding axial grooves 1130 of inner portion 1040. The teeth 1132 of the inner portion 1040 lie in axial sliding engagement with the corresponding recesses 1220 of the outer portion 1039.

The forward facing circumferential surface 1221 is seen to lie rearward of and in touch engagement with the rearward facing surfaces 1136 of the teeth 1132 of the inner portion 1040.

Returning now to Figure 6B, it is observed that the cover removal assembly 1038 is moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 6A-6D, such that the forward facing surface 1209 1201 serving base

IMPI

Mexican Institute of Industrial Property

<img file="MX336571B_D0032.tif" />

Outer 1039 is positioned along the lili axis at a typical 47mm clearance from the front edge 1036 of the front housing 1034. The axial clearance between the forward facing surface 1043 and the front edge 1036 of the front housing 1034, remains at a typical 4.8 mm gap.

In this case, due to the extremely short length of the syringe and the most rearward position of the cover, there is no axially floating lost motion coupling between the outer portion 1039 and the inner portion 1040, since the rear facing surfaces 1136 of the teeth 1132 of the inner portion 1040 are engaged by and pulled forward by the forward-facing circumferential surface 1221 of the outer portion 1039, causing corresponding movement of the inner portion 1040 with the removable needle cover 1045 within it, and thereby axial separation along the lili axis of the rearward facing edge 1049 of the relatively rigid outer portion 1047 of the cover of removable needle 1045 from front edge 1036 of front housing 1034, increases to 7.8 mm.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039, remains 12.8 mm.

IMPI

MEXICAN INSTITUTE OF PROPIEDAC 'industrial

<img file="MX336571B_D0033.tif" />

Returning now to Figure 6C, it is observed that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 6A-6D, such that the forward facing surface 1209 of the base 1201 of the outer portion 1039 is placed along the lili axis at a typical 49.4 mm spacing from the leading edge 1036 of the front housing 1034.

In this case, due to the extremely short length of the syringe and the most rearward cover position, there is no axially floating lost motion coupling between the outer portion 1039 and the inner portion 1040 and thus the axial separation along from the lili axis of the rear facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle cover 1045 from the front edge 1036 of the front housing 1034, increases to 10.2 mm.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 remains 12.8 mm.

Returning now to Figure 6D, it is noted that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 6A-6D, such that the

<img file="MX336571B_D0034.tif" />

IMPI

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL &amp; · · forward facing surface 1209 of base 1201 of outer portion 1039 is positioned along the lili axis at a typical 53mm clearance from leading edge 1036 of front housing 1034.

There is no axially floating lost motion coupling between the outer portion 1039 and the inner portion 1040, and thus the axial spacing along the lili axis of the rearward facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle 1045 from the front edge 1036 of the front housing 1034 is increased to 13.8 mm.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 remains 12.8 mm.

Reference is now made to Figures 7A-7D, which are simplified sectional illustrations of the inner and outer portions of the injector assembled cap removal assembly, in 4 stages of cap removal for a longer syringe length and a typically more rear deck position.

Figure 7A shows syringe 1041 having a length along the lili axis, which is the longest possible length that is within its manufacturing tolerances as described herein above.

<img file="MX336571B_D0035.tif" />

Similarly, Figure 7A shows placement 'axTST'TlU removable needle cover 1045 along the lili axis in the most rearward position relative to syringe 1041 that is within its manufacturing tolerances as described above in Present.

As seen in Figure 7A, when the injector is in a typical pre-use operating orientation, the forward facing surface 1043 is placed along the lili axis in front of and at a typical 9.9mm spacing from the leading edge 1036. front housing 1034.

The rearward facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle cover 1045 is positioned along the lili axis in front of and a typical 10.2 mm gap from the front edge 1036 of the front housing 3034.

The rear facing surface 1101 of the inner portion 1040 lies upward against the forward facing surface 1050 of the relatively rigid outer portion 1047 of the removable needle cover 1045, and is positioned along the lili axis rearward of and at a typical 8mm separation from the forward facing surface 1209 of the base 1201 from the outer portion 1039. The forward facing surface 1209 of the base 1201 of the outer portion 1039 is placed along the lili axis in front of and a typical 44.6 mm spacing from the

<img file="MX336571B_D0036.tif" />

industrial

IMPI »^NST1S ^ ÍIoS

<img file="MX336571B_D0037.tif" />

leading edge 1036 of front housing 1034. —-- The cylindrical base portion 1100 of the inner portion 1040 partially overlaps the generally circular cylindrical rearward-facing tubular portion 1212 of the outer portion 1039, in axially sliding relationship therewith, with the protrusions 1218 (not shown) of outer portion 1039 lying in axial sliding engagement with corresponding axial slots 1130 of inner portion 1040. The teeth 1132 of the inner portion 1040 lie in axial sliding engagement with the corresponding recesses 1220 of the outer portion 1039. The forward-facing circumferential surface 1221 of the outer portion 1039 is seen to lie backward and spaced from the surfaces facing back 1136 of teeth 1132 of inner portion 1040.

Returning now to Figure 7B, it is observed that the cover removal assembly 1038 is moved forward with respect to the front housing 3034, counterclockwise in the direction of Figures 7A-7D, such that the forward facing surface 1209 The base 1201 of the outer portion 1039 is placed along the lili axis at a typical 47mm spacing from the leading edge 1036 of the front housing 1034. The axial gap between the forward facing surface 1043 and the leading edge 1036 of the front housing 1034 remains at

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0038.tif" />

a typical 9.9mm gap. '

Due to the axially floating lost motion coupling between the outer portion 1039 and the inner portion 1040, this forward motion does not change the axial spacing along the lili axis between the rear facing edge 1049 of the relatively rigid outer portion 1047 of removable needle cover 1045 and front edge 1036 of front housing 1034, which remains at a typical 10.2mm gap.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 is increased to 10.4 mm.

Returning now to Figure 7C, it is observed that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 7A-7D, such that the forward facing surface 1209 of the base 1201 of the outer portion 1039 is placed along the lili axis at a typical spacing of 49.4 mm from the leading edge 1036 of the front housing

1034.

Due to the axially floating lost motion coupling between outer portion 1039 and inner portion 1040, this forward motion does not

IMPI

MEXICAN INSTITUTE CE IA INDUSTRIAL PROPERTY

<img file="MX336571B_D0039.tif" />

it changes the axial clearance along the lili axis between the rear facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle cover 1045 and the leading edge 1036 of the front housing 1034, which remains at a typical clearance of 10.2 mm. It is observed that the forward-facing circumferential surface 1221 lies rearwardly of and in tactile engagement with the backward-facing surfaces 1136 of the teeth 1132 of the inner portion 1040.

The axial spacing between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 is increased to 12.8 mm.

Returning now to Figure 7D, it is observed that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 7A-7D, such that the forward facing surface 1209 of base 1201 of outer portion 1039 is positioned along the lili axis at a typical 58.1 mm spacing from leading edge 1036 of front housing 1034.

At this stage there is no remaining available axially floating lost motion between the outer portion 1039 and the inner portion 1040 since the rear facing surfaces 1136 of the teeth 1132 of

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY the inner portion 104 0 are coupled by y'j winged forward by- the forward-facing circumferential surface 1221 of the outer portion 1039, causing a corresponding movement of the inner portion 1040 with the needle cover removable 1045 inside it, and thus the axial spacing along the lili axis of the rear facing edge 1049 of the relatively rigid outer portion 1047 of the removable needle cover 1045 from the leading edge 1036 of the front housing 1034 is increased to 18.9 mm.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 remains 12.8 mm.

Reference is now made to Figures 8A-8D, which are simplified sectional illustrations of the inner and outer portions of the cover removal assembly assembled on the injector in four stages of cover removal for a shorter syringe length and position. deck typically further forward.

Figure 8A shows syringe 1041 having a length along the lili axis, which is the shortest possible length that is within its manufacturing tolerances as described herein above. Similarly, Figure 8A shows the axial placement of

<img file="MX336571B_D0040.tif" />

MEXICAN INSTITUTE V &lt;· (

BE THE PROPERTY t «M

INDUSTRIAL the removable needle cover 1045 along the lili axis at the most forward location relative to the 1041 syringe which is within its manufacturing tolerances as previously described herein.

As seen in Figure 8A, when the injector is in a typical pre-use operating orientation, the forward facing surface 1043 is placed along the lili axis in front of and at a typical separation, 4.8 mm from the leading edge. 1036 of the front housing 1034. The rear facing edge 1049 of the relatively stiff outer portion 1047 of the removable needle cover 1045 is positioned along the lili axis in front of and a typical 10.2mm gap from the front edge 1036 of the front housing 1034.

The rear facing surface 1101 of the inner portion 1040 lies up against the forward facing surface 1050 of the relatively stiff outer portion 1047 of the removable needle cover 1045, and is positioned along the lili axis in a forward direction. behind and at a typical 8mm separation from the forward facing surface 1209 of the base 1201 from the outer portion 1039. The forward facing surface 1209 of the base 1201 of the outer portion 1039 is positioned along the lili axis in front of and at a typical spacing of 44.6 mm from the leading edge 1036

<img file="MX336571B_D0041.tif" />

ΙΜΡ_ ^WST,nJ7 '? * í^w'^cYear

PE INDUSTRIAL PROPERTY

<img file="MX336571B_D0042.tif" />

front housing 1034.

The cylindrical base portion 1100 of the inner portion 1040 partially overlaps the cylindrical, generally circular, backward-facing tubular portion 1212 of the outer portion 1039, in axially sliding relationship therewith, with the protrusions 1218 (not shown) of the outer portion 1039 lying in axial sliding engagement with corresponding axial grooves 1130 of inner portion 1040. The teeth 1132 of the inner portion 1040 lie in axial sliding engagement with the corresponding recesses 1220 of the outer portion 1039. It is noted that the. Circumferential forward-facing surface 1221 of outer portion 1039 lies backward and spaced from rearward facing surface 1136 of teeth 1132 of inner portion 1040.

Returning now to Figure 8B, it is observed that the cover removal assembly 1038 is moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 8A-8D, such that the forward facing surface 1209 The base 1201 of the outer portion 1039 is placed along the lili axis at a typical 47mm spacing from the leading edge 1036 of the front housing 1034. The axial gap between the forward facing surface 1043 and the leading edge 1036 of the front housing 1034 remains at

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0043.tif" />

a typical separation of 4.8 mm.

Due to the axially floating lost motion coupling between the outer portion 1039 and the inner portion 1040, this forward motion does not change the axial spacing along the lili axis between the rear facing edge 1049 of the relatively rigid outer portion 1047 of removable needle cover 1045 and leading edge 1036 of front housing 1034, which remains at a typical 10.2mm gap.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 is increased to 10.4 mm.

Returning now to Figure 8C, it is observed that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 8A-8D, such that the forward facing surface 1209 of base 1201 of outer portion 1039 is positioned along the lili axis at a typical 49.4mm spacing from leading edge 1036 of front housing 1034.

Due to the axially floating lost motion coupling between outer portion 1039 and inner portion 1040, this forward motion does not change the axial clearance along the lili axis between the edge

IMPI

DELA PRO.'EDA O INDUSTRIAL MEXICAN INSTITUTE

<img file="MX336571B_D0044.tif" />

Backward facing 1049 of the relatively stiff ovt ^ rnA pcxoion 1047 of the removable needle cover 1045 and the leading edge 1036 of the front housing 1034, which remains at a typical 10.2mm spacing. It is observed that the forward-facing circumferential surface 1221 lies to the rear of and in tactile engagement with the rear-facing surfaces 1136 of the teeth 1132 of the inner portion 1040.

The axial spacing between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 is increased to 12.8 mm.

Returning now to Figure 8D, it is observed that the cover removal assembly 1038 is further moved forward with respect to the front housing 1034, counterclockwise in the direction of Figures 8A-8D, such that the forward facing surface 1209 of the base 1201 of the outer portion 1039 is placed along the lili axis at a typical spacing of 53 mm from the leading edge 1036 of the front housing 1034.

At this stage there is no remaining available axially floating lost motion between the outer portion 1039 and the inner portion 1040 since the rear facing surfaces 1136 of the teeth 1132 of the inner portion 1040 are engaged by and pulled toward

IMPI

MEXICAN INSTITUTE

OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0045.tif" />

forward by the forward-facing circumferential surface 1221 of the outer portion 1039, causing corresponding movement of the inner portion 1040 with the removable needle cover 1045 therein, and thus axial separation along the lili axis of the rear facing edge 1049 of the relatively rigid outer portion 1047 of removable needle cover 1045 from the front edge 1036 of the front housing 1034 is increased to 13.8 mm.

The axial separation between the rear facing surface 1101 of the inner portion 1040 and the forward facing surface 1209 of the base 1201 of the outer portion 1039 remains 12.8 mm.

Figures 9 - 10C show complete decoupling of cover removal assembly 1038 and removable needle cover 1045 from the remainder of the injector.

It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly previously described herein. Rather, the scope of the invention is intended to include the combinations and sub-combinations of various features described herein above as well as the modifications and variations thereof which could occur to persons skilled in the art after reading the foregoing.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0046.tif" />

and that they are not in the prior art. - ___, ___,

It is noted that in relation to this date, the best method known by the applicant to put the aforementioned invention into practice is the one that is clear from the present description of the invention.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX336571B_D0047.tif" />