Multiple use disposable injection pen.

(54) Title: MULTIPLE-USE DISPOSABLE INJECTION PEN.

(54) Title: MULTIPLE USE DISPOSABLE INJECTION PEN.

(57) Summary

A medicine injection pen (51) includes a housing (1) and a dose adjustment knob (2) that has at least one internal tooth (22). A brake member (5) has a plurality of axially extending grooves (52). A push or pull member (9) includes at least one outer tooth (92) that engages at least one inner tooth (22) of the dose adjustment knob (2) and at least one sprocket arm (96) engaging the plurality of axially extending grooves (52). The impeller (9) is prevented from rotating with the dose adjustment knob (2) while moving axially with the dose adjustment knob (2) during dose adjustment and dose correction, and the impeller (9 ) rotates with the dose adjustment knob (2) during an injection.

(57) Abstract

A medication injection pen (51) includes a housing (1) and a dose set knob (2) having at least one internal tooth (22). A brake member (5) has a plurality of axially extending splines (52). A driver or setback member (9) includes at least one external tooth (92) engaging the at least one internal tooth (22) of the dose set knob (2) and at least one ratchet arm (96) engaging the plurality of axially extending splines (52). The driver (9) ¡prevented from rotating with the dose set knob (2) while moving axially with the dose set knob (2) during dose setting and dose correcting, and the driver (9) rotates with the dose set knob (2 ) during an injection.

<img file="MX358144B_D0001.tif" />

PATENT TITLE No. 358144

ΙΜΡΙίΐ ^ \! ί ι ι - «« · ar * t'tHi.Mtfiu ΊββΟ *

<td>Headlines):</td><td>BECTON, DICKINSON AND COMPANY</td>

<td>Home:</td><td>1 Becton Drive, Franklin Lakes, New Jersey, 07417-1880, USA</td>

<td>Denomination.</td><td>MULTIPLE USES DISPOSABLE INJECTION PEN.</td>

Classification:

Inventor (s):

CIP: A61M5 / 315; A61M5 / 20; A61M5 / 24

CPC: A61M5 / 31528; Α61μΒ / 3154ΓγΑ61Μ6 / 31551; A61M5 / 31575; A61M5 / 31585

MICHAEL QUINN; RICHARD CRONENBERG '. *'. : -¼

Number:

MX / a / 2013/010427

Country:

US

<img file="MX358144B_D0002.tif" />

tional:

Number:

617457.391

Validity: Twenty years

VWitfmientW date March 16 dé ?. 2032

Issue Date £ from a ^ o ^ od &amp; 2018

The reference patent is granted with fueRtaae ^ o in Ms articles V ^ fr ^ i ^ i III, and 59 of the Industrial Peopiet ^ d Law.

In accordance with article 29 of the Law of the WojíartfflrSubnal lá prese ^ e ^ pafenft tie jbfea twenty Moa ^ hp'rogrogables, counted from the date of filing &lt;fe la solK ^ Jd international pagd'défti ¡afa-perB. rñéntjaar vigorqteslqs «felpchos.

Who subscribes the present tifido hfcp with fundamtjnto eh Ibdispt'íesteperios * pliers 6th fractions III and 7th tos 2 defaLey of the Industrial Property (Official Gazette of the Federation (OOF). 27 / <© l991, Reformed ef · 02 ( Ó8M9®4, ®MOrt996S2W12 / 1997, · 06/17/1995. 01/26/2004, 06/16/2005, 01/25/2006, 06/05/2009 / 06/01/2010, ISrtWáDjO, 2 & / Ο6 / 20Ϊ & ρ27 / β / 2012> ® / 04/2012 »artl ^ ftloaul », 3“ fraqqónVméiso a), 4 'and 12' sections I and III of the Regulations of the Mexican Institute of IndusthaJ Property (liOF 1Μ / Ϊ2Λ999, réfojmedL / l O1 / O7 / ÍO02, 15Λ7Τ2004, 07/28/2004 and 09/07/2007); articles 1, 3, 4, 5, section V, subsection SMÍi Iónico delJnstitet ^ Jto ^ gape / de la Propiedad Industrial (DOF

12/27/1999, amended on 10/10/2002, 29/0 ^^ (and 5 pcISP-aplel AOuerdorjue delegates powers to the Directors

Deputy Generals, Coordinator. Divisional Deputy Directors, Coordinators

Departmental and other subordinates of the Ins §ΐίβ &amp; ^^^^ 5 / „12/1999, amended on 04/02/2004, 07/29/2004,

08/04/2004 and 09/13/2007). *

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 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.

<img file="MX358144B_D0003.tif" />

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

<img file="MX358144B_D0004.tif" />

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax | 1695 || MX / 2018/65806 | MX / a / 2013/010427 | PCT patent title | 1223 | GAGV | Page (s) | mwq2Sr3Yg6DX5IHYqXFs6lyGwEs =

Digital Stamp: qrqFF1jlyNfTMHVgqQsw6 + aOQ2k74YUkqy + wAOJzVYaOgB + g1npXulHpg062fcJIQ77pGM3EVGZbzlODQpTHbKxq82

EBjDSH + y5Ej2b8CSaqCBihrh0cTwUsVqisv58CXNITzgjFrlk8t / Riri2sxJrmCGet4Ku1t6VdeXdq + m0p + Rblo3gR mB6E73t¡5yWHLHwpCAAInrolJG6tRT9dl1MK6hcV69KnqQMRVs9DST6hRnOK9J7LE2n5uV5gBo8j8qnkyyQrzHCkdG

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Ajerial No. 550, Γ-ο: ο i, í'o.-r.lo Sarita Mana Tepepan, XocIiíitiiIco, 16020. 'O.nl.ld do M'OXiCd.

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Pl / tau⁰¹³!⁰¹⁰⁴²·'¹·

IMPIAS

358/4

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0006.tif" />

MULTIPLE USE DISPOSABLE INJECTION PEN

REQUESTS

RELATED

The present application claims the benefit under the provisional patent application of

USA Serial No. 61 / 457,391, filed on

2011, which is incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to an all-purpose pen-type injection device with improved functionality, including improved dialing of a set dose and the latest improved dose control to prevent a set dose that is greater than the amount of drug from being set. left in a medicine cartridge.

BACKGROUND OF THE INVENTION

Various devices of the medicine injection pen are known in the foregoing. These prior art devices sometimes include features to allow a user to correct a dose that has been set too large, which may be referred to as highlighting.

Another feature that may be provided by some of the prior art devices is the ability to control a last dose of a drug cartridge in such a way that a user cannot set a dose greater than the remaining amount of drug in the cartridge. . This feature

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0007.tif" />

it is known as last dose control or last dose management. Both features are desired by users of such pen devices, however, prior art devices do not satisfactorily meet these needs. Many prior art devices can provide one of these features, but not both. Furthermore, many of the prior art devices require additional steps to be performed to redial, as this is cumbersome and non-intuitive for the user. Therefore, there is a need in the art to provide better highlighting functionality and ultimate dose control mechanisms together in a drug injection pen.

SUMMARY OF MODALITIES OF THE INVENTION

Illustrative embodiments of the present invention address at least the above problems and / or disadvantages and provide at least the advantages described below.

IMPI

MEXICAN INSTITUTE OE LA ERO INDUSTRIAL AGE

<img file="MX358144B_D0008.tif" />

In accordance with an illustrative embodiment of the present invention, a drug injection pen includes a housing and a dose adjustment knob having at least one internal tooth. A brake member has a plurality of axially extending grooves. An impeller includes at least one outer tooth coupled to at least one inner tooth of the dose adjustment knob and at least one sprocket arm engaging the plurality of axially extending grooves. The impeller cannot rotate with respect to the dose adjustment knob while moving axially with the dose adjustment knob during dose adjustment and dose correction and the impeller rotates with the dose adjustment knob during an injection.

In accordance with another illustrative embodiment of the present invention, a drug injection pen includes a housing and a dose adjustment knob for adjusting and correcting a dose. A brake member is axially and rotationally fixed to the housing. An impeller moves axially with the dose adjustment and dose adjustment knob, and rotates rotary with the dose adjustment knob when the set dose is injected. A hollow piston rod moves axially when the set dose is injected. A brake core member is disposed within the hollow piston rod to prevent

IMPI

MEXICAN INSTITUTE BE LA FROFIEDAT INDUSTRIAL

<img file="MX358144B_D0009.tif" />

substantially the rotational movement of the hollow piston rod.

Additional objects, advantages, and salient features of illustrative embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the accompanying drawings, discloses illustrative embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing illustrative features in addition to others and the advantages of certain illustrative embodiments of the present invention will become more apparent from the following description of certain illustrative embodiments thereof when taken in conjunction with the accompanying drawings in which:

Figure 1 is a perspective view of a first illustrative embodiment of an injection pen according to the present invention;

Figure 2A is a perspective view of the injection pen of Figure 1 with a lower pen body removed;

Figure 2B is a developed view of the assembly of the injection pen of Figure 1;

The

Figure 2C is a

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0010.tif" />

part of the upper body of the ballpoint pen of Figure 2B;

The

Figure 3 is a top cross-sectional view of the injection pen of Figure 2A;

The

Figure is a perspective view of an adjustment knob

The Figure dose of is a recoil member of the

The Figure is Figure 3 seen in

Figure 3 A perspective side perspective view of a brake tower of the

Figure 3;

The

Figure is a view of the reverse coupling;

The between

Figure the tower is a lead screw of the Figure of brake seen in the perspective member of a

3;

Figure 9 is a view in reverse of Figure

The

Figure is a coupling between the front perspective member of the reverse view, and a lead screw of Figure 3;

The

Figure 11 is a cross-sectional view of the application between dose, spindle, recoil member

Figure 12 is a perspective view of the upper tower on the brake adjusting knob section and the brake tower;

upper in cross section of the dose setting knob and

IMPI MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0011.tif" />

recoil relative to the lead screw and brake tower after setting a dose;

Figure 13 is a perspective view of a dose stop member engaging the recoil member of Figure 3;

Figure 14 is a cross-sectional elevation view of the dose adjustment knob;

Figure 15 is a cross-sectional elevation view of the. dose stop member in a starting position;

<td></td><td>The figure</td><td>16 is a vi</td><td>sta in</td><td>partial lift</td><td>in</td>

<td>section</td><td>cross</td><td>member</td><td colspan="2">dose cap in</td><td>a</td>

<td>position</td><td>final;</td><td></td><td></td><td></td><td></td>

<td></td><td>The figure</td><td>17 is a</td><td>view</td><td>in elevation of</td><td>a</td>

<td>window</td><td>indicator</td><td>arranged in</td><td>a</td><td>upper portion</td><td>of the</td>

<td colspan="2">pen body</td><td>injection</td><td>of the</td><td>Figure 1;</td><td></td>

<td></td><td>The figure</td><td>18 is a</td><td>view</td><td>in elevation of</td><td>the</td>

The indicator window in Figure 17 indicates that a set dose has not been fully injected;

Figure 19 is a perspective view of the dose adjustment knob including an indicator;

FIG. 20 is an exploded assembly view of an injection pen in accordance with a second illustrative embodiment of the present invention;

The

Figure 21 is a view in e Lg μ ari ú'f i'en 'sec ai όι · ι · ordered transverse of

IMPI «ΤΓΤυΤΟ MEXICANO Dt LA PROPIEDAD INDUSTRIAL

<img file="MX358144B_D0012.tif" />

of the injection pen of Figure 20;

Figure 22 is an exploded assembly view of an injection pen according to a third embodiment example of the present invention;

Figure 23 is a cross-sectional elevation view of the injection pen

Figure is a brake core tower and a section tower view

<td>of</td><td>the figure</td><td> 22;</td><td></td>

<td>in</td><td>perspective</td><td>goes</td><td>of a</td>

<td>of</td><td>brake</td><td>the</td><td>Figure</td>

22;

The

Figure is a perspective view of the piston coupling of the

The between the core brake tower and a

Figure 22;

Figure is a perspective view of a piston rod;

The

Figure is a perspective view of the piston coupling of the

The transverse core and a ballpoint pen between the core brake tower and the rod of the

Figure 22;

Figure 28 is one of the injection advance screw coupling seen between the in the elevation section of the brake tower

Figure 22;

according to a fourth example of embodiment of the present invention;

The

Figure 29 is a perspective view of a

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0013.tif" />

<td></td><td>The</td><td>Figure</td><td> 30 &lt;</td><td>is</td><td colspan="5">an exploded overview</td>

<td>organized</td><td>of the</td><td colspan="2">pen</td><td>of</td><td>injection</td><td>of</td><td>the figure</td><td> 29;</td><td>the</td>

<td>Figure 31</td><td>is</td><td colspan="2">a sight</td><td>in</td><td>perspective</td><td>of</td><td colspan="3">a brake tower</td>

<td>from Fig</td><td>ura</td><td> 30;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure</td><td> 32</td><td>is</td><td>a sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>

<td>tower of</td><td colspan="3">core brake</td><td>of</td><td colspan="2">Figure 30;</td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure</td><td> 33</td><td>is</td><td>a sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>

<td>screw</td><td colspan="3">advance of the</td><td colspan="2">Figure 30;</td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure</td><td> 34</td><td>is</td><td>a sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>

piston rod of Figure 30 f

The

Figure 35 is a cross sectional elevation view of the injection pen of Figure 29

The

Figure 36 is a cross-sectional elevation view of the coupling between the brake tower, brake tower core, spindle and 1-piston rod of the

Figure 30;

The

Figure is a cross-sectional elevation view of a piston rod of the

Figure 30;

tower bar

Figure 38 is a piston according to the present invention;

one with a view of the fifth of the brake core according to the perspective of an example of embodiment the fifth illustrative embodiment of the present invention;

Figure 39 is a perspective view of a

The

Figure is a view

IMPI

MEXICAN INSTITUTE

OF INDUSTRIAL PROPERTY in perspective of

<img file="MX358144B_D0014.tif" />

coupling between the brake tower piston rod of the

Figures 38 and 39;

The

Figure 41 is a cross-sectional elevation view of an injection pen according to the fifth illustrative embodiment of the present invention;

Figure 42 is a cross-sectional elevation view of an injection pen according to a sixth illustrative embodiment of the present invention;

Figure 43 is a perspective view of a

<td>screw</td><td>advance of Figure 42;</td><td></td><td></td><td></td>

<td>The</td><td>Figure 44 is a view</td><td>in</td><td>elevation</td><td>in section</td>

<td>cross</td><td>of the feed screw</td><td>the</td><td>Figure 43</td><td>r</td>

<td>The</td><td>Figure 45 is a view</td><td>in</td><td>elevation</td><td>in section</td>

<td>cross</td><td>the coupling between</td><td>the</td><td colspan="2">tower brake</td>

<td>main and</td><td>spindle of Figure 42;</td><td></td><td></td><td></td>

<td>The</td><td>Figure 46 is a view</td><td>in</td><td>elevation</td><td>in section</td>

<td>cross</td><td>from the core tower of</td><td colspan="2">brake and the</td><td>set of</td>

<td>screw</td><td>advance that is inserted into</td><td>a</td><td>tower of</td><td>brake the</td>

<td>Figure 42;</td><td></td><td></td><td></td><td></td>

<td>The</td><td>Figure 47 is a view</td><td>in</td><td>elevation</td><td>in section</td>

<td>cross</td><td colspan="3">of the lead screw before</td><td>form a</td>

pressure connection with the brake tower;

IMPI

Figure 48 is a cross sectional view of the lead screw before forming the press fit connection of the brake tower;

Figure 49 is a cross-sectional elevation view of a snap connection between the lead screw and the brake tower;

Figure 50 is a cross-sectional elevation view of a piston rod inserted into the brake tower assembly of the

Figure 49;

Figure is an elevation view from one end of the brake tower assembly of Figure 50;

Figure 52 is a developed assembly view of an injection pen according to a seventh illustrative embodiment of the present invention;

Figure 53 is a cross-sectional elevation view of the injection pen of Figure 52;

Figure 54 is a perspective view of a dose adjustment knob of the injection pen of Figure 52;

Figure 55 is a cross-sectional elevation view of the injection pen of Figure 54;

Figure 56 is a perspective view of a recoil member of the injection pen of Figure

52;

<img file="MX358144B_D0015.tif" />

IMPI

MEXICAN INSTITUTE

Figure 57 is a view in

<img file="MX358144B_D0016.tif" />

cross section of the recoil member of Figure 56;

Figure 58 is a distal perspective view of the

<td colspan="5">recoil member of Figure 56;</td><td rowspan="2">in perspective</td><td rowspan="2">of a</td>

<td></td><td>The</td><td>Figure</td><td> 59</td><td>it's a sight</td>

<td>screw</td><td>of</td><td>Advance</td><td>of the</td><td>ballpoint pen</td><td>injection</td><td>Figure</td>

<td> 52;</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure</td><td> 60</td><td>it's a sight</td><td>in perspective</td><td>of a</td>

central brake tower of the injection pen of Figure 52;

Figure 61 is a perspective view of a brake tower of the injection pen of Figure 52;

Figure 62 is a cross-sectional elevation view of the brake tower of Figure 61;

Figure 63 is a perspective view of a piston rod of the injection pen of Figure 52;

Figure 64 is a cross-sectional elevation view of the piston rod of Figure 63;

Figure 65 is a perspective view of an upper body of the ballpoint pen of the injection pen of Figure 52;

Figure 66 is a cross-sectional elevation view of the upper body ballpoint pen of Figure

65;

<img file="MX358144B_D0017.tif" />

<td></td><td></td>

<td>The figure</td><td>MEXICAN INSTITUTE 67 is a view in pe? ^ ® ^ ga</td>

<td>mechanism body</td><td>action pen injection</td>

Figure 52;

Figure 68 is a bottom plan view of the

<td colspan="2">mechanism body</td><td colspan="2">action</td><td colspan="2">the figure</td><td> 67;</td><td></td>

<td>The</td><td>Figure 69</td><td>is</td><td>a</td><td>view</td><td>in</td><td>elevation of</td><td>Body</td>

<td>of mechanism</td><td>of action</td><td>of</td><td>the 1</td><td>Figure</td><td> 67;</td><td></td><td></td>

<td>The</td><td>Figure 70</td><td>is</td><td>a</td><td>view</td><td>in</td><td>plant from</td><td>above</td>

<td colspan="3">the body of the mechanism</td><td colspan="2">action of</td><td>the</td><td>Figure 67;</td><td></td>

<td>The</td><td>Figure 71</td><td>is</td><td>a</td><td>view</td><td>in</td><td colspan="2">proximal perspective</td>

of the brake tower of the injection pen of Figure 52;

Figure 72 is a perspective view of the lead screw and the core of the brake tower prior to engagement with the brake tower of the injection pen of Figure 52;

Figure 73 is a perspective view of the lead screw connected to the brake core tower before being connected to the brake tower of Figure 72;

Figure 74 is an elevation view of the lead screw and the core of the brake tower connected to the brake tower of Figure 72;

Figure 75 is an elevation view of the coupling between the piston rod and center brake tower of the injection pen of Figure 52;

IMPI

Figure 7 6 is a view in

INDUSTRIAL transverse of an action mechanism body arranged between a dose adjustment knob and a. recoil member of an injection pen according to an eighth illustrative embodiment of the present invention;

Figure 77 is a perspective view of the body of the action mechanism of Figure 76;

Figure 78 is a partial perspective view of the recoil member of the injection pen of Figure 76;

Figure 79 is a partial perspective view of the dose adjustment knob of the injection pen of Figure 76;

Figure 80 is a cross-sectional elevation view of the injection pen of Figure 76.

In all the drawings, similar reference numerals are understood to refer to the same elements, features and structures.

<img file="MX358144B_D0018.tif" />

DETAILED DESCRIPTION OF THE ILLUSTRATIVE MODALITIES

The topics exemplified in this description are provided to aid in a general understanding of the illustrative embodiments of the invention with reference to the figures of the accompanying drawings. Consequently, the experts

IMPIAS

MEXICAN INSTITUTE OF THE «INDUSTRIAL OPIEDAD

<img file="MX358144B_D0019.tif" />

Those of ordinary skill in the art will recognize that various changes and modifications to the illustrative embodiments described herein can be made without departing from the scope and spirit of the claimed invention. Also, descriptions of known functions and constructions have been omitted for clarity and conciseness.

Figure 1 depicts a view of an injection pen 51 in accordance with a first illustrative embodiment of the present invention. As shown, the injection pen 51 includes an upper part of the pen body or housing 1, which has a plurality of injection and dose setting components. The upper body of the pen 1 is connected to a cartridge housing 14, which houses a medication cartridge 15, as shown in Figures 2A and 2B. Injection pen 51 may also include a lower pen cap 12 to cover cartridge 15 and cartridge housing 14 when the injection pen is not in use. As shown, the injection pen 51 includes a dose adjustment knob 2 that includes a knob-like portion that is rotated by a user to set a desired dose. The dose setting knob 2 also includes a plurality of numbers, as shown in Figure 2B, corresponding to a number of dosage units that is visible through a window 13 provided in the upper body of the pen 1. A user adjust dose 2 until dose window 13. Upper body

IMPI

Mexican Institute of Industrial Property

<img file="MX358144B_D0020.tif" />

rotates the “PeTilT3 of desired is visible on the pen 1 can comprise an arrow or other indicator to accurately indicate the dose is defined, the amount of external protection dose established. Once user presses set it is to avoid punctures lower pen 12.

Optionally you can also include when dose Figures 1, initial knob visible surface is shown, from which button a set

2A and 2B. Attach the Figure to the desired dose until fully injected.

can cover body second the

One by removing a needle the top cap of the pen 1 window to indicate it is complete, as an indicator or marker

19, outside of the knob through the second dose setting 2 is completed.

knob visible position notifies of shown in

27, as can be provided in dose adjustment 2 that window 55 only when the dose has returned to its position indicating that the injection process has been completed.

Figure 18 represents initial adjustment.

through dose 2 almost

As shown, from window 55 one is the user that the injection scenario when indicator 27 has returned, but not his is therefore completed.

Once marker 27 is visible in window 55, as shown in Figure 17,

IMPI the user is

INDUSTRIAL

<img file="MX358144B_D0021.tif" />

Prepared dose was fully injected.

Figure 3 depicts a cross section of an injection pen 51 in accordance with the first illustrative embodiment of the present invention. Reference to the individual components can be better understood in view of the developed assembly view shown in Figure 2B. As shown, a push button 3 is provided at a proximal end, closest to a user and furthest from a needle 56, from the upper body of pen 1. The push button 3 preferably comprises an annular rim or ring 57 which engages with a corresponding annular groove provided on the inner surface of the dose adjustment knob 2. The annular ring and annular groove is preferably a friction fit that holds the push button 3 in a biased position on the dose adjustment knob 2 under the force of a button spring 10, but allows the push button 3 to be pushed into the dose setting knob to inject a set dose.

The interior of the push button 3 accommodates a recoil bearing insert 8 which rests on an inner surface at a proximal end of a recoil member or the controller 9. The push button 3 is designed to rotate freely in the recoil bearing insert 8.

<img file="MX358144B_D0022.tif" />

cylindrical member, as shown in Figure-5, coaxial with and surrounded by the dose adjustment knob 2. The recoil member 9 is provided co-axially around a brake tower 5, as shown in Figure 6 , which is axially and rotatably fixed to the upper body of the ballpoint pen 1. The brake of the tower 5 co-axially surrounds a piston rod 6, as shown in Figure 3. The piston rod 6 includes a set of keys 62 which engage an internal groove in the brake tower 5 to rotatably lock the piston rod 6 for the brake of the tower 5. The piston rod 6 preferably includes a plurality of threads 64 provided on the inner surface thereof, as shown in Figure 3. Piston rod 6 coaxially surrounds a lead screw 4 that includes a series of thread turns 42 at least at its distal end, as shown in Figure 20. The threads of lead screw 42 are in threaded engagement with the internal thread 64 provided on the piston rod 6. As discussed below, due to its threaded engagement with lead screw 4, piston rod 6 is displaced in cartridge 15 during injection to be depressed on a stopper 16 disposed within cartridge 15 to expel a dose of medicine. A wavy bra or spring 11, as shown in Figures 2B and 3, is provided between

<img file="MX358144B_D0023.tif" />

IMPI a distal end of the industrial brake tower 5 to push the cartridge 15 in a distal direction to prevent any movement of the cartridge 15 during injection, and thus ensure that an exact dose is injected.

To set the dose using the injection pen 51 of the first illustrative embodiment, a user rotates the portion of the dose adjustment knob 2 with respect to the upper body of the pen 1. An outer surface 59 of the dose knob Dose setting 2 includes a thread 23, as best shown in Figure 19, which is in threaded engagement with a plurality of thread turns 17 (Fig. 2C) provided on the inner surface of the upper body of the pen 1, as shown in Figure 3. Accordingly, as the dose adjustment knob 2 is rotated with respect to the upper body of the pen 1, the dose adjustment knob 2 screw or advance at a distance from the upper body of the pen 1, as shown in Figure 3. The dose adjustment knob 2 includes a shoulder or annular ring 21 on the inner surface thereof near the proximal end, as shown in Figures 3 and 4. This annular shoulder 21 engages with an enlarged or head part 91 of the recoil member 9, as shown in Figures 3 and 5. The annular shoulder 21 of the dose adjustment knob 2 preferably comprises a

<img file="MX358144B_D0024.tif" />

IMPI

MEXICAN INSTITUTE Λ · plurality series of teeth or hoops of similar shape 92 provided in the widened head 91 of the recoil member 9. Preferably, the dose adjustment knob teeth 22 teeth or projections 22 that are and the teeth of the member of Setback 92 extend in opposite axial directions. During dose adjustment, the dose adjustment knob 2 is free to rotate with respect to the recoil element 9 in both clockwise and anti-clockwise directions. As this occurs, the plurality of teeth or protrusions 22 on the dose adjustment knob 2 pass the teeth 92 provided in the head portion 91 of the recoil member 9, thereby providing a tactile signal or clicking to indicate the adjustment of a dosage amount. As described later, the dose adjustment knob 2 is enabled to rotate relative to the recoil member 9 during adjustment due to a one-way sprocket that prevents the recoil member 9 from rotating together with the adjustment knob. dose 2 in the adjustment direction.

To correct a set dose that may be too high, the user simply rotates the dose adjustment knob 2 again in the opposite direction. Rotation of the dose adjustment knob 2 in this direction

IMPI

MEXICAN INSTITUTE CEU INDUSTRIAL PROPERTY

<img file="MX358144B_D0025.tif" />

does not transfer to recoil member 9 because one-way sprocket

<img file="MX358144B_D0026.tif" />

Recoil 9 and brake tower 5, as shown in Figure 7. Recoil member 9 near its distal end includes a pair of sprocket arms 96, as shown in Figure 5 and Figure 7. The pair of sprocket arms 96 engage a plurality of grooves or teeth 52 provided on the outer surface of the brake tower 5, as shown in Figure 6 and Figure 7, The sprocket arms 96 and grooves or teeth 52 are configured to allow relative rotation in one direction only, that is, the direction that allows injection of a set dose. The friction provided between the sprocket arms 96 and the teeth 52 on the brake tower 5 is greater than the friction between the corresponding teeth 92 and 22 on the recoil element 9 and the dose adjustment knob 2, respectively. Therefore, the dose adjustment knob 9 can be rotated again to correct a set dose without causing the return member 9 to rotate in this direction. Consequently, teeth 92 and 22 provided on recoil member 9 and dose adjustment knob 2, respectively, slide together to provide a clicking sound during dose redialing, as well as during

<img file="MX358144B_D0027.tif" />

normal dose adjustment, from the established dose.

IMPb indicating from es c

INDUSTRIAL

As the dose adjustment knob 2 is screwed or axially advanced out of the upper body 1 during dose adjustment, the recoil member 9 is also driven to move axially out of the body by a corresponding distance. This axial movement is caused by the engagement between the annular shoulder 21 on the dose adjustment knob 2 which pushes against the elongated upper portion 91 of the recoil member 9 during its movement out of the body. Once a desired dose is established, the user presses the push button 3, which is coupled to the recoil bearing insert 8 which is axially connected to the recoil member 9. By virtue of the force applied by the user pressing the push button 3, the recoil member 9 moves in a gear locking or coupling system with the dose adjustment knob 2 through a gear between the teeth or Respective ridges 92 and 22 provided on the dose adjustment knob 2 and recoil member 9, respectively. As the user continues to press the push button 3, the dose adjusting knob 2 is rotated and downwardly screws it into the upper body of the pen 1 through the threaded coupling between the thread 23 on the adjusting knob dose 2 and the

IMPI

Mexican INSTITUTE thread 17 ** ^ ® $

<img file="MX358144B_D0028.tif" />

top of pen 1.

The rotation of the dose adjustment knob is then transferred to the recoil element 9 due to its locking or mesh engagement. The force of the user pressing the button 3 is sufficient to overcome the friction between the gearwheel arms 96 on the recoil element 9 and the teeth or grooves 52 in the brake tower 5. As a result, the recoil member 9 is enabled to rotate in this direction. TO

1Ό As the recoil member 9 rotates relative to the brake tower 5 during injection, the sprocket arms 96 produce a tactile or clicking signal as the sprocket teeth 52 pass in the brake tower 5. This indicates to the user that injection of the set dose is taking place.

The rotation of the recoil member 9, as allowed during injection, is then transferred to the advance screw 4, which is rotatably attached to the recoil member 9 through a pin groove connection 20 provided between the screw 4 and reverse 9. As shown in Figure 9, an inner surface 60 of the recoil member 9 includes a slot or groove 98 that is engaged with a pin 48 provided at the proximal end of the lead screw 4, as shown in Figure 10. The member of

IMPI

Mbxican institute of industrial property

<img file="MX358144B_D0029.tif" />

Reverse 9 preferably includes two opposingly arranged grooves 98 for engaging two opposingly arranged pins 48 provided in the lead screw 4. Reverse member 9 moves axially relative to lead screw 4 during dose adjustment and dose correction, via interconnect pin 98 and slot as shown in Figures 11 and 12. In one embodiment, the length of slot 98 in recoil member 9 can be configured to correspond to a maximum dose to be injected in a single injection.

The lead screw is axially fixed with respect to the upper body of the ballpoint pen 1 through a press fit with the brake tower 5 which is rotatably and axially fixed to the upper body of the ballpoint pen 1 as discussed below.

As shown in the Figures the screw includes a disk shaped portion

4 with an angled surface 45 allowing the lead screw 4 to snap behind an edge or set of protuberances 54 provided within the brake tower 5, as shown, thereby axially locking the lead screw 4 with respect to the upper body of the pen 1.

As previously described, lead screw 4 includes a plurality of threads 42 at its distal end that are in threaded engagement with a plurality of

IMPI institute mexican

OF THE FMPIEBAD

INDUSTRIAL

<img file="MX358144B_D0030.tif" />

of threads 64 preferably proportionate * s to the length of the entire length of a hollow piston rod

6, as shown in Figure 3. The piston rod remains non-rotating relative to the upper body of the pen due to non-rotating engagement with the brake tower

5, which is carried out rotatably and axially fixed with respect to the upper body of the pen

one. The piston rod 6 includes a pin or a set of pins 62 at its distal end that engage with a slot (Fig.

arranged on the inner surface of the brake tower 5 to avoid relative rotation between them while allowing the piston rod 6 to move axially with respect to it. They have a flat part 43 threads 42 of the lead screw 4 corresponding to a flat part of the piston rod so that axial movement of the lead screw during dose adjustment and dose correction does not result in axial movement of piston rod 6. Consequently, rotation of lead screw 4 during injection of a dose causes thread 42 of lead screw 4 to engage thread 64 of piston rod 6, thereby moving

<td>axially piston rod</td><td> 6.</td><td></td><td></td><td></td>

<td>During the assembly,</td><td>tower</td><td>of</td><td>brake 5 se</td><td>inserts</td>

<td>in the upper body of the</td><td>pen</td><td> 1</td><td>from the</td><td>extreme</td>

distal. As shown in Figure 3, the upper body

IMPI

INSTITUTO MEXICANO M LA HtOriEDA »industrial

<img file="MX358144B_D0031.tif" />

The ballpoint pen 1 includes a transverse wall ”18 that ITmitates the movement of the brake tower 5 in the body 1 by blocking an elongated distal portion 66 of the brake tower 5, as shown. Furthermore, an inwardly protruding pin 19 is also provided distally from the transverse wall 18 on the inner surface of the upper body of the pen 1, as shown in Figure 15. The pin 19 engages with a slot 55 provided in the elongated distal portion 66 of the brake tower 5, as shown in Figure 6, to rotatably fix the brake tower 5 with respect to the upper body of the ballpoint pen 1. Preferably, a plurality of axially extending pins 19 are disposed on the inner surface of the upper body of the ballpoint pen 1, as shown in Figure

15, to engage with a plurality of grooves in the elongated distal portion 66 of the brake tower 5.

Because the piston rod 6 is not rotatable with respect to the body

1, as the lead screw 4 is rotated during injection, as described above due to its rotational engagement with the return member 9, the piston rod through its threaded engagement with the lead screw moves in the distal direction to press against the stopper provided on the medicine cartridge

15, thus expelling liquid medicine from it. A mechanical advantage is

IMPI

Πίτπτυτο MEXICAN OF THE REoPtSDA · INDUSTRY !.

<img file="MX358144B_D0032.tif" />

preferably providing such a manp.ra · qiip 1¾ dose adjustment knob 2 further moves in the axial direction as the piston rod 6 during injection, reducing the injection force to be applied by the user.

This is preferably accomplished by providing different turns for the threaded connection between the dose setting knob 2 and the upper body of the pen 1 and the threaded connection between the lead screw 4 and the piston rod 6. The ratio of the thread turns it can vary depending on the liquid medicine and the volumes of the expected doses. For example, the ratio of turns may be 4.35: 1 or 3.25: 1, but they are not limited thereto. Piston rod 6 is prevented from moving in the proximal direction because the lead screw 4 can rotate in a single direction (resulting in distal movement of the piston rod 6) due to the wheel shape toothed between the recoil element 9 and the brake tower 5. Therefore, the exact dosage can be guaranteed because the piston rod 6 maintains its coupling with the plug 16 between injections.

A dose stop member 7, as shown in Figures 2b and 13, is provided for handling the last dose, to avoid setting a dose that is larger than the remaining amount of medication in cartridge 15. Dose stop member 7 is axially slidable, but rotatably fixed with

IMPI iNsrrruTO muk / aak?

OF THE WrtESAO

INDUSTRIAL

<img file="MX358144B_D0033.tif" />

with respect to the recoil element being positioned between a pair of grooves provided on the exterior surface of the recoil element 9. The member is a half-nut-like element, exterior are as shown, which with a plurality configured for corresponding 24 provided Dose 2 represents the initial one. As it is threaded with threads 72.

engage on its surface

These threads 72 with the threads on the inside of the knob of, as shown in Figure dose stop member shown, the stop member

14. The Figure in its dose position 7 is coupled to the thread with proximal threads 24 of one or two of those provided in the threads plus dose 2 adjustment knob. During the establishment of the dose, according to dose 2 rotates relative to recoil member 9 and slide stop member in corresponding coupling with dose 2.

During reverse rotation and as is therefore also related to dose 7, the direction of the dose stop member 7 is distal by a set distance due to its injection threads 24, on the appropriate adjustment knob discussed above. knob at which dose of the limb fit engages in, the stop member will maintain its position relative to the thread 24

MEXICAN INSTITUTE Λ / 'βιγ ^' OF ΙΛ PROPERTY ΛΧΤ) industrial> <ϊΓΑ? Ϋ́ of dose setting knob 2. The τη-i ^ mhro de._topp_ Hr · dose 7 will move in the distal direction during set The dose gauge to a distal edge 73 of the dose stop member 7 adjoins an inward facing pin 26 provided on the inner surface of the dose adjustment knob 2, as shown in Figures 14 and 16. In this position, the dose stop member 7 prevents further movement in the distal direction which also prevents further rotation of the dose adjustment knob 2 to establish an additional dose. In its final position, as shown in Figure 16, the dose stop member 7 is threadedly engaged with approximately two of the more proximal threads of the threads 24 provided on the dose adjustment knob 2. As shown with respect to Figures 15 and 16, the total distance traveled by stop element dose 7, from its initial position to its final position when adjacent to pin 26 provided on dose adjustment knob 2, is greater than the length of any of the thread portions 72 and 24 provided on the dose stop member 7 and the dose adjustment knob 2, respectively.

Figures 20 and 21 illustrate another embodiment with functionality similar to that described above, as is evident from the reference numbers commonly assigned to the various components in the form of lxx. Figures 20 and 21 illustrate an alternative modality of 4 - '- stellate dose mole 7', as shown. The dose stop member 107 remains a half-nut-like member, but is elongated with a larger number of threads 172. The

IMPI

MEXICAN INSTITUTE

OF THE PFTOMEDAO

INDUSTRIAL

<img file="MX358144B_D0034.tif" />

dose stop 107 is also now threadedly coupled with a single 3/4 length 129 thread provided in the

<td>inside</td><td>of the</td><td>adjustment knob</td><td>of</td><td>dose 102.</td><td colspan="2">The member</td>

<td>top of</td><td>dose</td><td>still slipping</td><td>in</td><td>the direction</td><td>distal</td><td>with</td>

<td>respect</td><td colspan="2">to the back member</td><td> 10 9</td><td>Of the same</td><td>way</td><td>than</td>

<td colspan="2">previously,</td><td>until it adjoins</td><td>with</td><td>the pin</td><td>12 6 in</td><td>the</td>

interior of dose adjusting knob 102. Alternatively, dose stop members 7 and 107 can be configured to similarly slide in the proximal direction during dose adjustment to the

<td colspan="2">stop dose</td><td>of the</td><td>members</td><td> 7</td><td>and 107</td><td>They support</td><td>in the</td>

<td>servings</td><td>of</td><td>size</td><td>increased</td><td> 91</td><td>and 191</td><td>near to</td><td>extreme</td>

<td>proximal</td><td>of</td><td>the</td><td>members</td><td>of</td><td colspan="2">reverse 9</td><td>and 109,</td>

respectively, further impeding value of a dose that exceeds the amount of drug remaining in cartridges 15 and 115.

Figures 22-28 illustrate a third illustrative embodiment of an injection pen 200 with functionality similar to the previous illustrative embodiments. The reference numbers have been included in the represented components are substantially the same in

IMPI

MEXICAN INSTITUTE

OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0035.tif" />

the 2xx form. Each of the components, .de.1 ·. Injection pen 200 is shown in Figures 22-28 and their respective functionality is substantially the same as in the previous illustrative embodiments unless otherwise described.

The exemplary embodiment depicted in Figures 22-28 includes an additional element referred to as the central tower brake 220. The brake tower core 220 is surrounded by brake tower 205 and is axially and rotationally fixed to the brake tower 205. As shown in Figure 24, the brake of the central tower 220 includes a plurality of teeth 222 provided on an enlarged surface 223 near the proximal end thereof. The plurality of teeth 222 preferably extends axially toward a distal end. The plurality of teeth 222 is configured to engage corresponding teeth 215 provided at a proximal end of brake tower 205. Engagement of the corresponding tooth prevents relative rotation between the brake of center tower 220 and brake tower 205. The brake tower 205 is fixed both axially and rotationally to the upper body of the pen 201 in the same manner as described above. As shown, the main brake tower 220 is a substantially cylindrical element with an open side 224 that extends along an axial length of the brake tower core 220, as shown in Figure 24. Open side 224 includes approximately one fifth to one quarter of the circumference of a cross section of the tower core

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0036.tif" />

brake 220. Open side 224 forms two longitudinally extending edges 225 and 226 at each end of open side 224.

The brake tower core 220 functions to prevent rotation of the piston rod 206 relative to the brake tower 205 and thus the upper body of the pen 201. As shown in Figures 25-27, the core of Brake tower 220 is surrounded by a hollow piston rod 206. The hollow rod 206 includes a plurality of thread segments 262 provided along substantially the entire length of the hollow piston rod 206. Each of the thread segments 262 is substantially equal in length to the open side circumference portion 224 of the brake tower core 220. The thread segments 262 extend inwardly into the inner cavity of the hollow piston rod. 206. An outer surface of piston rod 206 includes a plurality of segments of window 260 that are drilled through the surface of piston rod 206 to protrude therein. Window segments 260 are provided to aid in the manufacture of the hollow piston rod · '-2f) 6 - to form the internal thread segments 262.

Piston

206 is positioned with respect to the brake core

220 such that the segments align with and protrude the brake core tower,

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0037.tif" />

• ayüda-r__a_ tower bar thread 262 on the open surface 224 as shown on the edge surfaces which of the

Figures 25 and longitudinally extending 225 and 226 abut the respective edges of the protruding thread segments 262, such that the piston rod 106 is prevented from rotating with respect to the brake tower core 220.

As in the previous embodiment examples, a lead screw 204 is provided within the hollow rod 206 of the piston. A threaded portion 242 is provided at the distal end of lead screw 204. Threaded portion 242 is configured to engage threaded segments 262 provided within piston rod 206. As in the previous embodiment examples, lead screw 204 is rotatably attached to recoil member 209 such that rotation of recoil member 209 during an injection is transferred to lead screw 204. Axial motion of the lead screw 204 relative to the brake tower core 220 is avoided in the proximal direction by the threads of the lead screw 204 being more

IΜ Ρ ί

MEXICAN INSTITUTE J

OF THE RROriEDAD H

INDUSTRIAL larger than the diameter of the opening in an extruder_-i cn

230 of the brake tower core 220, as shown in Figures 23 and 28. Axial movement of the lead screw 204 relative to the brake tower core 220 is prevented in the distal direction by a tab 229 of the lead screw 204 engaging with enlarged portion 223 of brake tower core 220. As such, due to the thread engagement between the threaded portion 242 of the lead screw 204 and thread segments 262 on the hollow rod 206 of the piston, the relative rotation of the lead screw 204 relative to the piston rod 206 (which is fixed in rotation to the brake tower 205) drives the piston rod 206 axially in the distal direction inside the cartridge 215 to expel the medicine contained therein.

Figures 29-37 illustrate a fourth embodiment example of an injection pen 300 with similar functionality to the previous illustrative embodiments. The same reference numbers have been included in the represented components are substantially the same in the 3xx form. Each of the components of the injection pen 300 shown in Figures 29 to 37 and their respective functionality is substantially the same as in the previous illustrative embodiments unless otherwise described.

IMPI iNsmirrt) Mexican

OF THE PRORITY

INDUSTRIAL

<img file="MX358144B_D0038.tif" />

The illustrative embodiment described in Figures 29-37 includes a modification of brake tower core 320. Brake tower core 320 is surrounded by brake tower 305 and is provided axially and rotationally fixed to brake tower 305. As shown in Figure 32, the brake tower core 320 has a pair of opposingly extending arms 321 and 322 extending from a proximal end 326 thereof. Tabs 324 and 325 extend upward from the ends of each of arms 321 and 322. Arms 321 and 322 are received by V-shaped notches 353 at a proximal end 354 of brake tower 305. The arms 321 and 322 receive disk-shaped portion 344 (Figure 33) from lead screw 304 such that tabs 324 and 325 abut with disk-shaped portion 344. Accordingly, lead screw 304 is allowed to rotate relative to center tower brake 320 during an injection. The brake tower 305 is both axially and rotationally attached to the upper body of the pen 30 in substantially the same manner as described above.

As shown, the brake tower core 320 is a substantially cylindrical element with an open side 327 that extends along an axial length of the brake tower core 320, as shown in Figure

32. Open side 327 includes approximately one-fifth to one-fourth the circumference of a cross section of brake tower core 320. The open side

327 forms two longitudinally extending edges 328 and

329 at each end of open side 327.

The brake tower core 320 functions to prevent rotation of the piston rod 306 relative to the brake tower 305 and thus the upper body of the pen 301. As shown in Figure 35, the tower core of Brake 320 is surrounded by a hollow piston rod 306. Hollow piston rod 306 has threads 342 that preferably extend substantially continuously along an entire internal surface 367 of piston rod 306, as shown in Figures 35 and 37. A tab or pin 361 it extends radially inward at a proximal end 362 of piston rod 306, as shown in Figure 34. A flange 366 for engaging plug 316 extends outwardly from a distal end of piston rod 306. Piston rod 306 is positioned relative to brake tower core 320 such that flange 361 is received in the open surface 327 of the brake core tower, as shown in Figure 35. In this position, the longitudinally extending pair of edges 328 and 329 adjoins the respective edges 363 and 364 of the flange

361 such that the piston rod 306 is prevented from rotating with respect to the brake tower core 320, thereby controlling the angular orientation of the piston rod 306. The flange or pin 361 is at one end

IMPI

MEXICAN INSTITUTE

BE THE PROPERTY

INDUSTRIAL

<img file="MX358144B_D0039.tif" />

<td>proximal of the bar</td><td>piston</td><td colspan="2">306 way</td><td>which can</td>

<td>stay in the opening</td><td>similar to</td><td>slot 327</td><td>of the</td><td>core of</td>

<td>320 brake tower like</td><td>the bar</td><td>piston</td><td> 306</td><td>does it move</td>

<td>distally.</td><td></td><td></td><td></td><td></td>

<td>Like</td><td>in the</td><td>examples</td><td>of</td><td>modality</td>

In the foregoing, a lead screw 304 is provided inside hollow piston rod 306, as shown in Figure 35. A threaded portion 342 is provided at the distal end of lead screw 304, as shown in Figure 33. Threaded portion 342 is configured to engage threaded segments 362 provided within piston rod 306. As in the previous embodiment examples, lead screw 304 is rotationally attached to recoil member 309 such that rotation of recoil members 309 during an injection is transferred to lead screw 304. Axial movement of the lead screw 304 relative to the brake tower core 320 is prevented in the proximal direction by the threads of the lead screw 204 being larger than the diameter of the opening at a distal end 330 of the tower core 320 brake, as shown

IMPI

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL

<img file="MX358144B_D0040.tif" />

in Figure 35. Axial movement of lead screw 304 relative to brake tower core 320 is prevented in the distal direction inward by extending through flanges 365 of brake tower 305 by engaging a slot 345 of lead screw 304 disposed between the enlarged portion 323 and the disk-shaped portion 344. As such, due to the thread engagement between the threaded portion 342 of the lead screw 304 and the threads 362 of the hollow piston rod 306, the relative rotation of the lead screw 304 relative to the piston rod 306 (which is fixed in rotation to the brake tower 305) drives the piston rod 306 axially in the distal direction within the cartridge 315 to expel the drug contained therein.

Figures 38 to 41 illustrate a fifth embodiment example of an injection pen 400 with functionality similar to the previous illustrative embodiments. The same reference numbers have been included in the represented components are substantially the same in the 4xx form. Each of the components of the injection pen 400 is shown in Figures 38 to 41 and their respective functionality is substantially the same as in the previous illustrative embodiments unless otherwise described.

The illustrative embodiment depicted in Figures 38-41 includes a further core modification of

IMPI Mexican Institute of the ρκοηεοΑπ

INDUSTRIAL

<img file="MX358144B_D0041.tif" />

brake tower 420. The brake tower core 420 is surrounded by the brake tower 405 and is axially provided and rotationally fixed to the brake tower 405. The brake of the central tower 420, as shown in Figures 39 and 40, has a plurality of teeth 422 provided on an enlarged surface 423 near a proximal end thereof. The plurality of teeth 422 preferably extends axially toward a distal end. Brake tower 405 is substantially similar to brake tower 205 shown in Figure 34 and has a plurality of corresponding teeth 215 provided at a proximal end 216 of brake tower 205 (Figure 24). The coupling between the brake tower teeth 215 (Figure 34) and the central teeth of the brake tower 422 prevents relative rotation between the brake of the central tower 420 and the brake tower 405. The brake tower 405 is both axially and rotationally attached to the upper pen body 401 in the same manner as described above.

As shown in Figure 39, the brake of the central tower 420 has substantially flat opposing walls 491 and 493 extending from the enlarged portion 423. An open side 424 is formed between the opposing walls 491 and 493 extending thereto. along an axial length of the brake tower core 420. Open side 424 includes approximately one-fifth to one-quarter the circumference of a

IMPI

MEXICAN INSTITUTE OF LA ΕΕΟΙΊΕΙ., .Υ. , INDUSTRIAL section tran

<img file="MX358144B_D0042.tif" />

of the brake tower core 420. The side - two longitudinally extending edges 425 and 426 at each end of the open side 424.

The brake tower core 420 functions to prevent rotation of the piston rod 406 relative to the brake tower 405 and thus the upper part of the pen body 401. As shown in Figures 38 and 40, the Brake tower core 420 is surrounded by a hollow piston rod 406. The hollow piston rod 406 has threads 462 that extend along an entire internal surface thereof. A hole 381 extends from a proximal end 382 to a distal end 383 of piston rod 406. Opposite ribs 384 and 385 of an opening 386 for access to hole 381 are substantially flat, as shown in Figure 38.

The piston rod 406 is positioned with respect to the brake tower core 420 such that the flat walls 491 and 493 of the brake tower core 420 are received by the flat portions 484 and 485 of the opening of the hole 486 of the piston rod 406. Lead screw 404 is inserted through the brake tower core 420 such that the threads of lead screw 442 engage the threads of piston rod 462 beyond a distal end 494 of the tower core. 420 brake.

IMPI

NWniTO MEXICANO OE LA PROMtOAO ΙΝΓΜΙ $ Τ * ΙΑΙ

<img file="MX358144B_D0043.tif" />

Rotation of lead screw 404 during an injection results in axial movement of piston rod 406 due to thread engagement therebetween. Coupling between the flat walls 491 and 493 of the brake tower core 420 and the flat parts 484 and 485 of the piston rod 406 prevent rotation of the piston rod 406 relative to the brake tower core 220 during injections.

As in the previous illustrative embodiments, the lead screw 404 is rotatably attached to a recoil member 409 such that rotation of the recoil member 409 during an injection is transferred to the lead screw 404. Axial movement of the lead screw 404 relative to the brake tower core 420 is prevented in the proximal direction by the threads of the lead screw 404 which is larger than the diameter of the opening at a distal end 494 of the brake tower 420, as shown in Figure 41. Axial movement of lead screw 404 relative to brake tower core 420 is prevented in the distal direction by a flange 429 of lead screw 404 by engaging enlarged portion 423 of center tower brake 420. As such, due to the thread engagement between the threaded portion 442 of the lead screw 404 and the threads 462 of the hollow piston rod 406, the relative rotation of the lead screw * ··· 'ί * i'

IMPI '' W'nyro Mexican PROPERTY

INDUSTRIAL

<img file="MX358144B_D0044.tif" />

404 With respect to the piston rod 406 (which is ~ ”fixed Ho ^ erT 'rotation to the brake tower 405) actuates the piston rod 406 axially in the distal direction within cartridge 415 to eject the drug contained therein.

Figures 42 to 51 illustrate a sixth embodiment example of an injection pen 500 with similar functionality to the previous illustrative embodiments. The same reference numbers that have been included in the represented components are substantially the same in the 5xx form. Each of the components of the injection pen 500 is shown in Figures 42 to 51 and their respective functionality is substantially the same as in the previous illustrative embodiments unless otherwise described.

<td>How</td><td>It is shown in</td><td>Figure</td><td>11 the</td><td>screw</td>

<td>advance 4 se</td><td>snaps</td><td>in a</td><td>ring</td><td>disrupted</td>

<td>forming a</td><td colspan="3">plurality of protuberances 54</td><td>over one</td>

On the sixth inner surface of the brake tower 5.

illustrative mode, a lead screw

504 has a continuous ring 591 where a brake tower

505 adjusted as shown in Figure 42.

The continuous ring

591 it is a flexible member to facilitate assembly as well as disassembly resistance forces due to the continuity of ring 591.

IMPI

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL

<img file="MX358144B_D0045.tif" />

Lead screw 504 has 'rosOa' ~ outer ring-542 formed at a distal end 543 to engage threads of a piston rod 506, as shown in Figures 43 and 44. Continuous ring 591 is disposed at a proximal end 544 of lead screw 504. Continuous ring 591 has an inner surface 592 and an outer surface 593. A circumferential ring 594 extends from inner surface 592 of ring 591. The circumferential ring 594 has an angled surface 595, as shown in Figure 44, to facilitate insertion of the brake tower 505.

<td></td><td>A</td><td>core</td><td>of</td><td colspan="2">tower 520 is</td><td>arranged in</td><td>the</td>

<td>screw</td><td>of</td><td>Advance</td><td> 504,</td><td>as shown</td><td>in</td><td>Figure 45.</td><td>The</td>

<td>core of</td><td>to</td><td>rre 520</td><td colspan="2">it has a surface</td><td>abi</td><td colspan="2">erta to receive</td>

<td colspan="2">the screw</td><td colspan="2">forward</td><td>504. The screw</td><td>of</td><td>advance 504 and</td><td>the</td>

<td>core</td><td>of</td><td>tower</td><td>brake</td><td> 520</td><td>I know</td><td colspan="2">they insert</td><td>continuation</td><td>to</td>

<td>through</td><td>of</td><td colspan="2">one opening 581</td><td>in</td><td>a</td><td>extreme</td><td colspan="2">proximal 583 of</td><td>the</td>

<td>tower</td><td>of</td><td>Brake</td><td>505 like</td><td>I know</td><td colspan="2">shows in</td><td>the</td><td>Figure 46.</td><td>The</td>

Opening 581 at proximal end 583 of brake tower 505 is then flexed outward to receive enlarged portion 523 of brake tower core 520, as shown in Figures 47 and 48. Lead screw 504 It has not yet been connected to brake tower 505 to allow opening 581 at proximal end 583 of brake tower 505 to decompress, thereby reducing the

IMPI Mexican institute OF PROPERTY

INDUSTRIAL

<img file="MX358144B_D0046.tif" />

tension on it. The enlarged portion. — 523, „of the brake tower core 520 is received within an internal cavity of the brake tower 505.

As shown in Figure 4 9, lead screw 504 is press-fitted to brake tower 505. Oppression of lead screw 504 in the distal direction causes the angled surface 595 of edge 594 of ring 591 flex outward along an inclined surface 584 at proximal end 583 of brake tower 505. The circumferential ring 594 snaps into a depression 585 formed in an outer surface 586 of the brake tower 505 adjacent to the proximal end 583 thereof. The 520 core brake tower has not yet been locked in rotation to the 505 brake tower of

<td colspan="2">such that</td><td>the</td><td>tower</td><td>of</td><td>core brake</td><td>52 0 is</td><td>free of</td>

<td>turn.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>How</td><td>I know</td><td>shows</td><td>in</td><td>Figure 50, the</td><td>bar</td><td>piston</td>

<td>50 6 se</td><td>inserts</td><td>in</td><td colspan="2">The cavity</td><td colspan="2">tower internal</td><td>brake 505</td>

from a distal end of it. The internal thread 562 of the piston rod 506 is threaded into the thread 542 (Figure 45) of the lead screw 504 such that the piston rod 506 is threaded in the proximal direction in the brake tower 505. Piston 506 is threaded to a proximal end 563 of piston rod 506 that adjoins enlarged portion 523 of brake tower core 520. The jackal, · -ΐιιιιιΐ ||.

IMPI

MEXICAN INSTITUTE »E LA ΙΜ · Μ (· αΒ INDUSTRIAL

<img file="MX358144B_D0047.tif" />

central brake tower 520 is pushed —eH-sta-lanente__en 1 to brake tower 505, thus locking central brake tower 520 to brake tower 505. A pin (not shown) is inserted through a break 543 into the lead screw thread 542 to facilitate locking the brake tower core 520 to the brake tower 505.

Figures 52 to 75 illustrate a seventh exemplary embodiment of an injection pen 600 with functionality similar to the preceding illustrative embodiments. The same reference numbers have been included in the depicted components are substantially the same in form 6xx. Each of the components of the injection pen 600 is shown in Figures 52 through 75 and their respective functionality is substantially the same as in the previous illustrative embodiments unless otherwise described.

The exemplary embodiment depicted in Figures 52 through 75 includes an additional element which is referred to as an action mechanism body 680, as shown in Figures 52 and 67 through 70. The action mechanism body 680 is surrounded by the dose adjustment knob 602, as shown in Figure 53. An upper surface 681 of an upper ring 682 is engaged by a push button 603. A lower surface 689 of upper ring 682 is coupled by a distal end L 690 of a recoil member

IMPI • ΜίΤΓΠΠΟ MEXICANO • E LA RTOMEDAD INOUSTWal

<img file="MX358144B_D0048.tif" />

609. A pair of flexible arms 683 are 'edT'ÍtÍc LdLlus to the top ring 682, as shown in Figures 67, 68 and 70. A bottom ring 684 is connected to the top ring 682, as shown in Figure 69. The lower ring 684 has a pair of flexible arms 685 connected to it, as shown in Figures 67 and 68. The hooks 686 are arranged at the free ends of the upper ring flexible arms 683 and the hooks 687 are arranged at the free ends of the lower ring flexible arms 687. Preferably, the inclined surfaces of the upper part of the hook ring 686 and the 687 lower ring hooks form an angle of approximately 15 degrees. An opening 688 is formed in the actuation body 680 to receive push button 603. The flexible ring upper hooks arm 686 engage teeth 691 of the dose set knob 602, as shown in Figure 53. The flexible lower ring arms hooks 687 engage teeth 692 of the recoil member 609.

Brake tower core 620 is surrounded by brake tower 605 and is provided axially and rotationally fixed to brake tower 605. As shown in Figures 60 and 72-74, brake tower core 620 has a pin 623 that extends axially to the proximal end. Pin 623 is received by a shaped notch

<img file="MX358144B_D0049.tif" />

IMPI

MEXICAN INSTITUTE

M LA PMniDA »iNaumuAt

<img file="MX358144B_D0050.tif" />

of V 653 arranged at a proximal end! of the brake tower 605. Pin 623 has inwardly tapered sides, as shown in Figures 72 through 74, to facilitate engagement with the V-shaped notch 653 of the brake tower 605, thereby rotationally locking core brake tower 620 to brake tower 605. Brake tower 605 is attached both axially and rotationally to the upper body of ballpoint pen 601 in the same manner as described above. As shown in Figure 60, the brake tower core 620 is a substantially cylindrical element with an open side 624 that extends along an axial length of the brake core tower 620. The open side 624 includes approximately one fifth to one quarter the circumference of a cross section of the brake core tower 620. Open side 624 forms two longitudinally extending edges 625 and 626 at each end of open side 624.

The brake core tower 620 operates to prevent rotation of the piston rod 606 relative to the brake tower 605 and thus the upper body of the ballpoint pen 601. As shown in Figure 53, the core tower 620 The brake caliper is surrounded by a hollow piston rod 606. The hollow piston rod 606 includes internal threads 662 that extend along substantially the entire length of the hollow piston rod 606, as shown in

IMPI 'NSTTnjTO MEXICANO os LA PROHEBAO industrial

<img file="MX358144B_D0051.tif" />

Figures 63 and 64. Piston rod 606 is offset from the brake core tower 620 in such a way that an internally extending pin 661 engages with the longitudinally extending edges 625 and 626 of such that piston rod 606 is prevented from rotating relative to brake tower core 620, as shown in Figure 75.

As in the previous embodiment examples, a lead screw 604 (Fig. 59) is provided inside hollow piston rod 606. A threaded portion 642 is provided at the distal end of lead screw 604. The Threaded portion 642 is configured to engage internal threads 662 of piston rod 606. As in the previous embodiment examples, lead screw 604 is rotationally attached to recoil member 609 such that rotation of recoil member 609 during an injection is transferred to lead screw 604. Lead screw 604 it is press-fit on brake core tower 620, which is press-fit on brake tower 605, as shown in Figures 53 and 72-74. A flange 633 of lead screw 604 is received by a slot 632 (Figure 60) of brake core tower 620 such that a proximal end of brake tower core 620 is received by an annular slot 645 of brake screw guide 604 arranged between proximal flange 646

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL and the tab 644 tab for a lip

<img file="MX358144B_D0052.tif" />

633 is separated inward - thereof ... One of the brake core tower 620 is received extending inward 665 from the brake tower 605. The axial movement of the lead screw 604 in proximal relation is supported by brake tower 605 is prevented in the direction by flange 644 of the tower core from the lip extending inwardly from the proximal brake tower from axial motion

605. The proximal brake tower 620

665 Axial motion prevention brake core of the screw is connected by a press fit to the brake 620. The relative to distal direction

620 tower advance prevents the

604, that of the axial movement of the advance screw 604

604 adjoining the brake tower a flange 646

605 avoids the screw of a distal end of the tower

605. As such, due to hollow piston lead screw 604 606, fixed lead drives the

604 rotationally with respect to the piston rod inside the cartridge 615 in the advance brake coupling between the thread 642 of the internal threads 662 in the rod relative rotation of the al screw

606 piston rod 606 (which is axially cored to move the medicament contained therein.

in the distal direction stop 616 to eject

To set the dose using the injection pen 600 of the seventh illustrative modality, the user

<img file="MX358144B_D0053.tif" />

IMPI MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY rotates the knob portion with respect to -aJ -— em-expQ ____ superior of pen 601 of dose adjustment knob 602. An outer surface 659 of the dose setting assembly 602 includes a thread 619, as shown in Figures 54 and 55, which is in threaded engagement with a plurality of threads 617 provided on the inner surface of the upper part of the pen body. 601, as shown in Figures 65 and 66. Accordingly, as the dose adjustment knob 602 is rotated relative to the top of the pen body 601, the dose adjustment knob 602 is screwed or advances a distance outside the top of the pen body 601 (Figure 3) . The dose adjustment knob 602 includes a shoulder or annular ring 621 on the inner surface thereof near the proximal end, as shown in Figure 5. Annular shoulder 621 engages with an enlarged or head portion 699 (Figs. 56-58) of recoil member 609, as shown in Figure 53. Annular shoulder 621 of set dose knob 602 preferably comprises a series of teeth or protrusions 622 that mate with a plurality of teeth or protrusions 698 provided on the enlarged head 699 of the recoil member 609. Preferably, the teeth of the dose adjustment knob 622 and the teeth of the recoil member 698 extend in opposite axial directions. During dose setting, the

IMPI

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL

<img file="MX358144B_D0054.tif" />

pQ-gka- rotate oon in both directions, counter-clockwise dose adjustment knob 602 is relative to recoil element 609 clockwise to clockwise. As this occurs, the plurality of teeth or protrusions 622 on the dose adjustment knob 602 slides past the teeth 698 provided in the head portion 699 of the recoil member 609, thereby providing a tactile signal or clicking to stop. indicate the setting of a dose quantity. As described later, the dose adjustment knob 602 is enabled to rotate relative to the recoil member 609 during adjustment because a one-way sprocket prevents the recoil member 609 from rotating along with the adjustment knob. dose 602 in the direction of adjustment.

The 680 action mechanism body facilitates the generation of a tactile or clicking signal during dose adjustment. The upper ring hooks 686 of the actuation body 680 are closed on teeth 691 (Figures 54 and 55) of the set dose knob 602 such that the actuation body rotates with the adjustment knob of dose 602 as the dose adjustment knob 602 advances out of the upper body of the 601 pen. Lower ring hooks 687 slide over teeth 692 (Figs. 56 and 57) of recoil element

609. Consequently touch signal or clicking to be adjusted a dose.

To correct a dose that was too high, the directional rotation adjustment knob did not

IMPI

MEXICAN INSTITUTE OF THE INDUSTRIAL EROMEOAD

<img file="MX358144B_D0055.tif" />

, a noise is generated to indicate to the user that it is established that there may be a user simply rotates the dose the knob is transferred to the back

602 in the opposite direction. The limb fit of to the one-way sprocket recoil 609 and the brake tower dose 602 at this recoil 609 due between the limb of

605. The recoil member 609 has a pair of wheel arms as shown in the Figures

56-58. Pair of sprocket arms 696 mates with a plurality of tooth grooves 652 provided on the outer surface of brake tower 605, as shown in Figures 61 and 62.

Arms

696 of sprocket and grooves or teeth

652 they are configured to allow relative rotation in one direction only, namely the direction that allows injection of a set dose. The friction provided between sprocket arms 696 and teeth 652 on brake tower 605 is greater than the friction between corresponding teeth 698 and 622 on recoil member 609 and dose adjustment knob 602, respectively. Therefore, the set dose knob 609 may rotate again to correct a set dose without causing rotation of the recoil member 609 in that direction. TTT ^ In-crrr &amp; sequence, teeth 692 and 622 provided on the recoil element

609 and the dose setting knob 602,

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358144B_D0056.tif" />

respectively, they slide together to provide a click sound during subsequent dose dialing, as well as during normal dose adjustment, thereby indicating correction of the set dose.

The body of action mechanism

680 also facilitates clicking or

generation of a tactile signal

<td>during the correction of</td><td>the</td><td>dose.</td><td colspan="2">Ring hooks</td>

<td>lower body 687</td><td>of</td><td colspan="3">mechanism of action 680 are</td>

<td>hooked to the teeth</td><td> 692</td><td>(Figs.</td><td>56 and 57) of the element</td><td>of</td>

<td colspan="2">recoil 609 in such a way</td><td>that he</td><td>mechanism body</td><td>of</td>

<td>action 680 is blocked</td><td>of</td><td>shape</td><td>swivel to member</td><td>of</td>

Setback Knob 609. Rotation of Dose 602 as Dose Adjustment Knob 602 is advanced back into the upper body of Pen 601 to correct the dose causing teeth 691

55) of the set dose knob

602 slides over the lower ring hooks 687 of the action mechanism body 680, thereby generating a tactile or click signal to indicate to the user that a dose is being corrected.

Consequently, the action mechanism body facilitates the generation of a tactile signal or clicks

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY ».

<img file="MX358144B_D0057.tif" />

during both dose adjustment and. the. . dose correction.

Since the dose adjustment knob 602 is screwed or axially advanced out of the upper body 601 during dose adjustment, the recoil member 609 is also forced to move axially out of the body by a corresponding distance. This axial movement is caused by engagement between the annular shoulder 621 in the dose adjustment knob 602 which pushes against the enlarged upper part 699 of the recoil member 609 during its movement out of the body. Once a desired dose is established, the user presses the push button 603 that engages the action mechanism ring 680 which is axially connected to the recoil element 609. By virtue of the force applied by the user pressing the push button 603, the recoil member 609 moves in a gear locking or latching system with the dose adjustment knob 602 through a mesh of the respective teeth or hoops 698 and 622 provided on the dose adjustment knob 602 and recoil member 609, respectively. As the user continues to press the push button 603, the dose adjustment knob 602 is rotated and screwed down into the upper body of the pen 601 by thread engagement between thread 619 on the dose adjustment knob 602 and the

IMPI

MEXICAN INSTITUTE Γ? · * OF THE PROPERTY 'Ofci INDUSTRIAL

<img file="MX358144B_D0058.tif" />

thread 617 in the upper body of r ”” &amp; Wt ± -gTafo- - 601 ·. - The rotation of the dose adjustment knob 602 is then transferred to the recoil member 609 due to its mesh engagement or mesh. The force of the user pressing button 603 is sufficient to overcome friction between sprocket arms 696 in recoil member 609 and teeth or grooves 652 in brake tower 605. As a result, recoil member 609 is enabled to rotate in this direction. As recoil member 609 rotates relative to brake tower 605 during injection, sprocket arms 696 produce a tactile or clicking signal as sprocket teeth 652 pass to brake tower 605. This indicates to the user that injection of the set dose is taking place. Because the dose adjustment knob 602 and the recoil member 609 rotate together during injection, the action mechanism body does not rotate with respect to either the dose adjustment knob 602 or the recoil member 609. Consequently, the action mechanism body 680 rotates with the dose adjustment knob 602 and the recoil element 609 such that the action mechanism body 680 does not generate a tactile signal or click when a dose is injected. established.

The rotation of recoil member 609, as allowed during injection, is then transferred,

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358144B_D0059.tif" />

to the screw cable 604, which is4 — .fi4 ^ dQ ~ ...- of-_dÍQXJiia. rotatable to recoil member 609 through a pin groove connection provided between lead screw 604 and recoil member 609. As shown in Figures 56 and 57, an internal surface 668 of recoil member 609 includes a groove or groove 697 that mates with a pin 648 provided at the proximal end of lead screw 604, as shown in Figure 59. The recoil member 609 preferably includes two oppositely arranged grooves 697 to engage two oppositely arranged pins 648 provided on the lead screw 604. The recoil member 609 moves axially relative to the lead screw 604 during adjustment of dose and dose correction, via pin 648 and interconnect slot 697 (substantially similar to Figure 10). The length of slot 697 in recoil member 609 may be configured to correspond to a maximum dose to be injected in a single injection. Lead screw 604 is axially fixed with respect to the upper pen body 601 through a pressure coupling described above with the brake tower 605, which is rotatably and axially fixed to the upper part of the pen body 601 as described later. As shown in Figures 72 through 74, lead screw 604

IMPI

MEXICAN INSTITUTE OF THE INDUSTRIAL PRORIEOAD

<img file="MX358144B_D0060.tif" />

includes the flange facing -qrre- received by depression 632 in the brake core tower 620. The flange 644 of the core of the brake tower 620 is received by the inwardly extending lip 665 of the brake tower 605, thereby axially locking the lead screw 604 to the brake tower 605 and the top of the pen body 601.

As previously described, lead screw 604 includes a plurality of threads 642 at its distal end that are in threaded engagement with internal threads 662 preferably provided along the entire length of hollow piston rod 606, as shown in Figures 53 and 64. The piston rod 606 is kept non-rotatable with respect to the upper body of the pen 601 due to the coupling between the piston rod 661 and the pin on the outer edges 625 and 626 of the brake tower core 620, as shown in Figure 75. The piston rod pin 661 is guided in its axial movement by the axially extending outer edges 625 and 626 of the brake tower core 620, thereby preventing relative rotation therebetween while allowing the piston rod 606 moves axially with respect to it. As recoil member 609 does not rotate during dose adjustment and correction, lead screw 604 does not rotate

IMPI

MEXICAN INSTITUTE M INDUSTRIAL PROPERTY

<img file="MX358144B_D0061.tif" />

during dose adjustment and correction, which prevents movement of piston rod 606 during dose adjustment and correction. Accordingly, rotation of lead screw 604 during injection of a dose causes thread 642 of lead screw 604 to engage threads 662 of piston rod 606, thereby axially moving piston rod 606.

During mounting, the brake tower 605 is inserted into the top of the pen body 601 from the distal end. As shown in Figures 53 and 66, the upper body of the pen 601 includes a transverse wall 660 that limits the movement of the brake tower

605 in body 601 by locking an elongated distal portion 666 of brake tower 605.

Furthermore, an inwardly protruding pin 663 is also provided distally from the transverse wall 660 on an inner surface 664 of the upper body of the pen 601, as shown in Figure 66. Pin 663 mates with a slot 655 provided in elongated distal portion 666 of brake tower 605, as shown in Figures 61 and 62, to rotationally fix brake tower 605 with respect to the upper body of the ballpoint pen 601. Preferably, a plurality of axially extending pins 663 are disposed on the inner surface of the upper body of the

IMPI

Mexican Institute of Industrial Property

<img file="MX358144B_D0062.tif" />

<td colspan="2">ballpoint pen 601 for</td><td>engage with</td><td colspan="2">a plurality of grooves</td>

<td> 655</td><td>in the portion</td><td>distal elongated</td><td>666 of</td><td>the brake tower</td>

<td> 635.</td><td></td><td></td><td></td><td></td>

<td></td><td>Because</td><td>that the bar</td><td>piston</td><td>606 cannot rotate</td>

<td>with</td><td colspan="2">regarding body 601, I confess</td><td>sign me</td><td>lead screw</td>

<td> 604</td><td>spins</td><td colspan="2">during the injection,</td><td>as described</td>

Previously due to its rotary engagement with recoil member 609, piston rod 606 through its threaded engagement with lead screw 604 is moved in the distal direction such that a piston rod flange 618 is pressed against the stop 616 arranged in the medicine cartridge 615, thus expelling the same liquid medicine. Piston rod 606 is prevented from moving in the proximal direction because lead screw 604 is rotatable in one direction (resulting in distal movement of piston rod 606) due to the one-way sprocket between the back member

609 and the brake tower

605.

A mechanical advantage is preferably provided such that the dose adjustment knob 602 moves more in the axial direction than the piston rod 606 during injection, reduces the injection force that must be applied by the user. This is preferably accomplished by providing different contact points for the threaded connection between the dose setting knob 602 and the upper body of the pen 601.

IMPI

MEXICAN INSTITUTE

OF THE PROPERTY

INDIJSTKL'.L

<img file="MX358144B_D0063.tif" />

and the threaded connection between lead screw 604 and piston rod 606. The relationship between threaded contact points can vary depending on the liquid medication and the expected dose volumes . For example, the contact point ratio may be 4.35: 1 or 3.25: 1, but is not limited to them. Therefore, exact dosing can be guaranteed because piston rod 606 maintains its engagement with plug 616 between injections.

A dose stop member 607, as shown in Figure 53, is provided for the last dose adjustment to prevent a dose greater than the amount of drug remaining in cartridge 615 from occurring. The dose stop member 607 is axially slidable, but fixed in rotation with respect to the recoil element 609 when placed between a pair of grooves 694 provided on the outer surface of the recoil element 609. Dose stop member 607 is a half-nut-like element (Figure 2b) that is threaded on its outer surface with a plurality of threads 672. These threads 672 are configured to engage the corresponding threads 674 provided within the dose adjustment knob 602, as shown in Figure 55. During dose adjustment, as the dose adjustment knob 602 rotates relative to the recoil member 609, and therefore also

IMPI

MEXICAN INSTITUTE • E LA FXONt'JAL INDUSTRIAL

<img file="MX358144B_D0064.tif" />

Relative to dose stop member 607, dose stop member 607 is slid in the distal direction by a distance corresponding to the set dose due to its engagement with threads 674 on dose adjustment knob 602.

During injection, because the recoil limb

609 and the dose adjusting knob 602 is rotatably engaged as discussed above, the dose stop member 607 will maintain its position relative to the threads

674 of dose adjustment knob 602. Dose stop member 607 will move in the distal direction during dose setting until a distal edge

673 of the dose cap member

607 abut with an inward facing peg

675 provided on the inner surface of the dose set knob 602, as shown in Figure 55. In this position, the dose stop member

607 Further movement in the distal direction is prevented which also prevents further rotation of the dose adjustment knob 602 to establish an additional dose.

Figures 76-80 illustrate an eighth illustrative embodiment of an injection pen with similar functionality to the injection pen of the seventh illustrative modalities shown in Figures 52-66 and 71

75. The exemplary embodiment depicted in Figures 76-80 includes a drive mechanism body.

<img file="MX358144B_D0065.tif" />

IMPI wsrmno μϊχκλνο FROM THE 'UmsOAO' NOUETUlAl

<img file="MX358144B_D0066.tif" />

replaces the 780 action mechanism body of the Figures

52-66 and 71-75. The rest of the components and functions of the injection pen are substantially similar to the injection pen 600.

The actuation body 751 is substantially ring-shaped having an upper set of teeth 752 and a lower set of teeth 753, as shown in Figures 76 and 77. Preferably, the upper teeth 752 have a slope that is opposite of the lower teeth

753. Preferably, the sloping surfaces of the upper teeth 752 and the lower teeth 753 form an angle of approximately 15 degrees. As shown in Figures 7 6 and 80, the action mechanism body 751 is disposed between an annular shoulder 725 of the dose adjustment knob 702 and an enlarged portion 731 of the recoil member 709. A plurality of teeth 721 that extend axially in the proximal direction from shoulder 725 of dose adjustment knob 702.

A plurality of teeth 723 extend axially in the distal direction from the enlarged portion 731 of the recoil member 709. A support insert 708 is received in an annular groove 726 of the recoil member 709, as shown in Figure 80. A push button 703 has a

IMPI

ICυ INDUSTR MEXICAN INDUSTRIAL PROPERTY

<img file="MX358144B_D0067.tif" />

projection 733 received by an opening 734 in bearing insert 708. A distal skirt 735 of push button 703

<td>is received from</td><td colspan="2">sliding shape</td><td>by</td><td>depression 736</td><td>adjacent</td>

<td>to an extreme</td><td>proximal</td><td>737 of</td><td>the</td><td>adjustment knob</td><td>dose</td>

<td> 702.</td><td></td><td></td><td></td><td></td><td></td>

<td>The</td><td>body of</td><td colspan="2">mechanism</td><td colspan="2">Action 751 facilitates</td>

generation of a tactile or clicking signal during dose adjustment. The upper teeth 752 of the action mechanism body 751 are locked to the teeth 721 (Fig. 79) of the dose adjustment knob 702 such that the action mechanism body 751 rotates with the dose adjustment knob 702 As the dose adjustment knob 702 advances out of the upper body of the pen. Lower teeth 753 sliding on teeth

<td>723 (Figure</td><td> 78)</td><td>of the</td><td colspan="2">member</td><td>of</td><td colspan="2">ret recess</td><td> 709.</td><td>In</td>

<td>consequence,</td><td>I know</td><td>generate</td><td>a</td><td>noise</td><td>of</td><td>the</td><td>signal</td><td colspan="2">touch OR</td>

<td>clicking</td><td colspan="3">For indicate</td><td colspan="2">to user</td><td>than</td><td>a</td><td>dose</td><td>this</td>

being tight.

The action mechanism body 751 also facilitates the generation of a tactile or clicking signal in dose correction. The lower teeth 753 of the actuation body 751 are locked to the teeth 723 (Figure 78) of the recoil member 709 such that the actuation body 751 is rotatably closed with the recoil member 709. The rotation

IMPI

MEXICAN INSTITUTE OF THE PROMEDAr;

INDUSTRIAL

<img file="MX358144B_D0068.tif" />

of the dose setting knob 702 as the dose setting knob 702 is advanced again into the upper body of the pen to correct the dose causing teeth 721 (Figure 79) of the dose setting knob 702 to slide on the lower teeth 753 of the action mechanism body 751, thereby generating a tactile signal or producing a click to indicate to the user that a dose is being corrected. Accordingly, the action mechanism body 751 facilitates the generation of a tactile signal or a clicking sound during both dose adjustment and dose correction.

Because the dose adjustment knob 702 and the recoil member 709 rotate together during an injection, the action mechanism body 751 does not rotate relative to either the dose adjustment knob 702 or the recoil member 709. Accordingly, the action mechanism body 751 rotates with both the dose adjustment knob 702 and the recoil member 709 such that the action mechanism body 751 does not generate a tactile signal or click when injection of a set dose.

While the present invention has been demonstrated, it is based on and described with reference to certain illustrative embodiments, which should not be restricted by these illustrative embodiments, but only by the claims.

IMPI

INSTITUTO MEXICANO DS LA rKOPIIDAD INDUSTRIA !.

<img file="MX358144B_D0069.tif" />

annexes and their equivalents. It is appreciated that those skilled in the art can change or modify the illustrative embodiments without departing from the scope and spirit of the present invention, as defined in the appended claims and their equivalents.

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MEXICAN INSTITUTE OF INDUSTRIAL FROPUDAD

<img file="MX358144B_D0070.tif" />