Automatic injectors for injectable cartridges and drive control mechanisms|therefor.

(54) Title: DRIVE CONTROL MECHANISMS AND AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES.

(54) Title: AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES AND DRIVE CONTROL MECHANISMS | THEREFOR.

(57) Summary

An autosampler 50 including a housing 52, 236 having a guide 158, a drive control mechanism, a transmission mount 110, a motor 106, and a power source. Housing 52, 236 may further include a cartridge cover 72. A drive control mechanism includes a screw 114, a cartridge holder 126, 202, a plunger holder 138, 194, 226, 242, and one or more control transfer instruments 150, 204, such as a disc or cylinder . Screw 114 interconnects and connects to plunger carrier 138,194, 226, 242. Autosampler 50 is configured to accept a variety of syringes as cartridges 54, 224 for drug delivery. Cartridges 54, 224 can be ejected from injector 50 and safely disposed of after use, making the injector a reusable auto injector 50. Reusable auto injector 50 may further include one or more sensors 160,165, such as a cartridge 160 sensor. and a patient sensor 165. The novel incorporation of drive control mechanisms into the automatic injectors 50 of the present invention allows a single engine 106 and a transmission assembly 110 to operate the multi-component function, which may include the steps of: preparation and alignment of a cartridge 54, 224 for injection, removal of a safety cap or protection of needle 60, injection of the needle, delivery of the drug dose, and retraction of the syringe and / or needle 58. Manufacturing methods and methods of use are also described.

(57) Abstract

An automatic injector (50) includes a housing (52, 236) having a guide (158), a drive control mechanism, a transmission assembly (110), a motor (106), and an energy source. The housing (52, 236) may further inelude a cartridge cover (72).

A drive control mechanism includes a drive screw (114), a cartridge carrier (126, 202), a plunger carrier (138, 194, 226, 242), and one or more control transfer instruments (150, 204), such as a puck or cylinder. The drive screw (114) interfaces and connects with the plunger carrier (138,194, 226, 242). The automatic injector (50) is configured to accept a variety of syringes as cartridges (54, 224) for drug delivery. The cartridges (54, 224) may be ejected from the injector (50) and safely disposed after use, making the injector a reusable automatic injector (50). The reusable automatic injector (50) may further include one or more sensors (160,165), such as a cartridge sensor (160) and a patient sensor (165). The novel incorporation of the drive control mechanisms into the automatic injectors (50) of the present invention enables a single motor (106) and transmission assembly (110) to drive the function of multiple components, which may include the steps of: preparation and alignment of a cartridge (54, 224) for injection, removal of a safety cap or needle shield (60), needle injection, drug dose delivery, and syringe and / or needle (58) retraction. Methods of manufacture and methods of use are also disclosed.

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<img file="MX355019B_D0001.tif" />

PATENT TITLE No. 355019

<td>Headlines):</td><td>UNITRACT SYRINGE PTY LTD</td>

<td>Home:</td><td>Suite 3, Level 11,1 Chifley Square, 2000, Sydney, New South Wales, AUSTRALIA</td>

Denomination

DRIVE CONTROL MECHANISMS AND AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES.

Classification:

CIP: CPC:

Α61Μ37φΑθ [1ΐν | 5 / ^) (Α ^ Ι ^ 24

A6 ^ 37 / 00- ^ 6 ^ / 20: Ά61 ^ 24 / |

International inventor (s)

Number

The patent of refere

<img file="MX355019B_D0002.tif" />

expendable, counted to

KEVIN BQWfLMAN, GEORGE MARLÍI% STEFANIE A. H tu

Number

MX / a / 2014/015873

Country:

US

LÍS

Validity: Twenty years

Date of Ve

Ex Date

Pursuant to the as of the date of prese

Who subscribes to this title, (Official Gazette of the Federation 25/01/2006, 06/05 / 2009,06 / 01/2010, Regulations of the Mexican Institute of articles 1^or, 3°, 4^or, 5^or fraction V subsection a),

12/27/1999, amended on 10/10/2002, 07/29/20 Deputy Generals, Coordinator, Departmental Directors and other subordinates of the Mexican Institute on 08/04/2004 and 09/13/2007).

AS F. MCGEE; ARTHUR G. N; ELLEN NI CHATHAIL e (a | fe? Be la industrial.

Industrial Property Law 999, 01/26/2004, 06/16/2005, íflfo a), 4^or and 12th sections I and III of 07/2004, 07/28/2004 and 09/07/2007); (Mexican Industrial Property (DOF Agreement that delegates powers to the Directors, Divisional Sub-directors, Coordinators F. 12/15/1999, amended on 02/04/2000, 07/29/2004,

III 26/12 /

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.

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

<img file="MX355019B_D0003.tif" />

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax ^ 695 || MX / 2018/27333 | MX / a / 2014/015873 | PCT patent title | 1027 | RGZ | Page (s) 1 | PgUnKqfwqSra0x40 / jEXmKNC0BQ =

Digital label: i4seFfpSFgMWDVwyBTH5L36Z7ndvkhRQutpRDDRzRXrZnTnqt991gvOO2LepHNUNSF60P0GxyN2Hd4mADoz1kvc93B OnRkP4Q9jmGhiSZvQ5uH3nzZ7X37ZCzzOsALb8VZps + GLfG / INRCYG / ZpCTirXfCFUtxbopseDqOblZmoX + KT5F5bh 8IDA7przgYeLsW6EOjskH2186Wspeqfoi7D2oqeg3KlPoODWr5bVs6S7MNEBIWTkOc73VY¡AThrvhT3XnyJPcxyP1V / YLZblcam7VqdHsVZNKsHWBYnhvWajwVGk8mmiGOwCKP7m8gYljWnOKGGrgOTtCp / 9H2vPIQ ==

Arenal No. 550 Piso 1, Pueblo Santa María Tepepan, Xochimilco, 16020, Mexico City.

(55) 53340700 www.gob.mx/impi

<img file="MX355019B_D0004.tif" />

MX / 2018/27333

DRIVE CONTROL MECHANISMS AND INJECTORS “Mxlako '^ b¹^-⁵

<img file="MX355019B_D0005.tif" />

AUTOMATIC FOR INJECTABLE CARTRIDGES

CROSS REFERENCE TO RELATED REQUESTS

This patent application claims the benefit of Provisional Patent Application No. 61 / 683,499 filed on August 15, 2012, and No. 61 / 668,303, filed on July 5, 2012, which are incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to reusable automatic injection devices. More specifically, the embodiments of the present invention relate to electromechanical automatic injection devices, which use motor-driven drive mechanisms, incorporating replaceable injection syringes, and which perform one or more of the steps of: preparation and alignment of the injection syringe, removal of the safety cap, injection of the needle and delivery of the drug dose, and retraction of the needle and / or syringe. The present invention also relates to drive mechanisms for reusable automatic injection devices, methods of making such devices, and their methods of use.

<img file="MX355019B_D0006.tif" />

BACKGROUND OF THE INVENTION

<img file="MX355019B_D0007.tif" />

ActivAste »- ^ nanua ^ menfe-e 'prefilled cartridges are available from a variety of manufacturers, including the owner and assignee of the present invention. The owner and assignee of the present invention has developed a syringe that offers a unique and elegant integrated mechanism for retraction of the needle and / or syringe. Currently, visual, tactile or audible indicators are generally related to the end of the stroke or some other mechanical mechanism and not to the end of the dose. The syringe with the integrated needle retraction retracts the needle into the barrel, withdrawing it from the patient's skin once the dose is complete.

The prefilled cartridges are used in the administration of drug solutions, drug suspensions , vaccines, medicinal therapies, and any other liquid medication by parenteral injection. Such prefilled cartridges include a primary drug chamber, a hypodermic needle permanently attached to, 20 and in fluid communication with the drug chamber, and a piston slidably received in the drug chamber. The pistons of frequently pre-filled cartridges include a plunger subassembly, which includes an inner plunger and an outer plunger, to drive liquid medicine out of the needle. Prefilled cartridges are typically prepared by companies

<img file="MX355019B_D0008.tif" />

Contractors who fill them in a sterile filling manner, in which the drug and the cartridge are brought together in a sterile manufacturing environment, where all of the drug's components and solutions are isolated from microbial contamination.

In contrast to pre-filled cartridges activated manually, automatic injection devices, commonly known as auto-injectors, are also available. Such autoinjectors, once activated by the user, use an automatic mechanism to insert a hypodermic needle into the recipient's meat \ at the injection site and push the liquid medicine out of a medicine compartment, through the hypodermic needle. , and towards the receiver. In addition to automatic needle insertion and dose delivery, some autoinjectors also incorporate retraction mechanisms to automatically retract the needle after use. Autoinjectors have proven particularly useful in allowing a medically untrained user to administer a parenteral injection, and can provide both psychological and physical benefits for patients.

Patients who need to inject medication for chronic disease management have used auto-injectors since the first reusable auto-injector was introduced in the 1990s.

<img file="MX355019B_D0009.tif" />

Provides protection for rejiLpísate --- Primary? · Generally, a pre-filled syringe, and offers an easy way for automatic injection of medication. These devices offer increased convenience and autonomy to patients, as well as providing a competitive advantage for the pharmaceutical partner, through device differentiation and increased sales, through patient compliance with their therapy. Autoinjectors can also be beneficial for supplying large volumes (up to 1 mL currently) and viscous drugs. Autoinjectors also work to prevent injury from needle sticking, by housing the needle into a chamber, inserting the needle into the patient for drug introduction, then retracting the needle back into the housing, using, for example, mechanisms reverse drives.

Some autoinjectors are designed to accept commercially available pre-filled cartridges. Such configurations can be made in the form of cartridges for auto-injectors (eg, reusable auto-injectors) or single-use auto-injectors. The syringes developed and manufactured by the owner and assignee of the present invention offer a unique and elegant integrated retraction mechanism for the safety of the /

Prefilled and cartridge can be used on such needles.

auto-injectors, including those sold by the assignee and owner of the present invention, under commercial name

Unifill covered by one of the following:

State patents

United

Us.

6,083,199,

7,500,967,

8,021,333,

8,002,745,

8,114,050,

7,935,087

8,167,937;

Publication of

States Patent

United No.

2011/0015572 and PCT International Applications

Us.

PCT / AU2010 / 001505,

PCT / AU2010 / 001677

PCT / AU2011 / 000515, all of which are incorporated herein by reference, in their entirety, for all purposes.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to new automatic drug injection devices for delivery with a built-in multifunctional drive control mechanism. The components of the automatic injection devices are configured for repeatable functionality. Accordingly, the automatic injectors of the present invention may be single-use devices, but are preferably used as reusable automatic injectors. Consequently, multiple single-use syringes can be used

<img file="MX355019B_D0010.tif" />

as cartridges with the automatic injectors of the present invention. The reusable autoinjectors of the present invention could be adapted for use with any type of retractable or safety syringe, but for simplicity, the invention is described when using a syringe similar to those sold by the owner and assignee of the present invention, under the trade name Unifill. Autosamplers are also designed to accept a variety of syringes as cartridges from the drug container.

The novel incorporation of drive control mechanisms into the automatic injectors of the present invention allows a single motor and gear to operate the function of multiple components, which may include the steps of: preparing and aligning a cartridge for injection, injection of the needle, delivery of the drug dose, and retraction of the syringe and / or needle. Optionally, the autosampler can also go through, before injection of the needle, removing the safety cap or the needle protection from the cartridge. Additionally, optionally, the autosampler can be configured to adjust the dose volume, such as sending a portion of the drug dosage to a reservoir, prior to injection of the needle and delivery of the drug dose to the user. Using a single

A 1 device control mechanism for multiple stages of the device, greatly simplifies the functionality of the autosampler and improves the reliability, operation and manufacturing cost of the reusable autosampler.

novel hereby repeatedly these

In addition, invention tasks, the injectors are capable of making them automatic perform from reusable automatic injectors.

Novel automatic machines capable of maintaining products

The modalities of the injectors of the present invention, may be to achieve all of these an appearance and existing in the reuse of rapidity of use and critical to the advantages, market size.

while also comparable to those

Simplicity and these automatic injectors facilitate patient acceptance, both metric general patient care and home use of automatic injectors.

In one embodiment, the present invention provides an automatic mechanism, of which actuator, plunger, and one control. May include a drive control including, a screw of a cartridge carrier, or more instruments of using a motor with one or more gears, connected directly or indirectly, to the screw of for a drive injector a carrier transfer of the gear train , either drive-drive, to control the movement of the carrier of the

T cartridge and piston carrier.

Transfer instruments — etei — eonfero-l can be, for example, a spherical ball, cylinder, disk or particle, or similar instruments that can move freely to control the transfer of the other components of the drive mechanism.

control can be cylinders (eg discs).

instruments the present form and the

The of

By instrument, preferably simplicity, the transfer of control document can be referred to as the actual dimensions disk can the standard cylindrical objects.

on or disks, although vary

The one of those transfer instrument works to control components ensuring they remain annular instrument control plunger that the action of the two inside objects control mechanism and making a transfer position or between those of the drive, that they move, or that fixed, can of the drive. In contains a recess of the cartridge carrier as a to retain unit components.

The in a one-mode mechanism space, the carrier carrier contains both of which reside instrument to control the operation of the drive.

Optionally, from the plunger, while a channel, within transfer can control mechanism, additional components can be used to hold the transfer instrument in a position from which it can control the transfer function. For example, uTia '^-iguideⁱwhat has^-'below the guide can be used for this purpose.

In one embodiment, the drive control mechanism for an autosampler includes a drive drive screw, a cartridge carrier, a plunger carrier, a guide, and two control transfer instruments.

Control transfer instruments can be in several different forms, including, for example, discs.

Transfer instruments can be retained in the annular spaces within or between the components of the drive control mechanism. The plunger carrier contains recesses of the plunger carrier, the cartridge carrier contains channels, and the guide has guide recesses for each transfer control instrument to interact with controlling the operation of the drive control mechanism.

For example, at an initial stage, the components of the drive control mechanism are aligned so that one or more control transfer instruments can freely pass between the guide recess and the plunger carrier recess through the cartridge carrier channel. When there are two or more control transfer instruments, there are guide recesses, channels, and

<img file="MX355019B_D0011.tif" />

ΙΝ5ΪΖ'i ot la llo-'iluau __ corresponding piston carrier recesses'^jrRfor^-ca3a · control transfer instrument; --— ΕΪ — recess¹· Plunger carrier and guide recess can be of several different configurations. In one embodiment of the present invention, the plunger carrier recess and the guide recess are symmetrical carvings of their respective components. Each of the recesses can be, for example, ramp-shaped, to drive movement of the transfer instrument outside, toward the guide recess, or inside, toward the plunger carrier recess. Since the drive drive screw moves axially, through motor operation and interaction with a gear or transmission mount, the transfer instrument can be driven out of the plunger carrier recess into the position between the guide recess and the channel of the cartridge carrier. In another stage of operation, the recess in the guide may align with the channel of the cartridge carrier. By interacting the other aspects of the guide and the cartridge carrier, as further described below, the transfer instrument can be moved out of the guide recess and into a position between the plunger carrier recess and the cartridge carrier. This alignment can cause the plunger holder and cartridge holder to move as one integrated unit.

·. Although the plunger carrier and the -cartucheXsííí ^ * ^ moving objects carrier, the guide remains as -a fixed nhjptn through the operation of the drive control mechanism.

In another embodiment, the present invention provides an autosampler including a housing having a guide, a drive control mechanism, a transmission mount, a motor, and a power source. The autosampler may also contain .0 certain standard features, such as, for example, a microprocessor or similar control system, that are known to someone of ordinary skill in the art. The housing may further include a cartridge cover. The .5 drive control mechanism may include various components, including a drive drive screw, a cartridge carrier, a plunger carrier, and one or more control transfer instruments. The cartridge carrier interfaces and connects to a cartridge, such as a syringe, 'O that supports a drug treatment for delivery to a patient. More particularly, a cartridge holder cartridge connection feature connects to a corresponding aspect of the cartridge. This may be, for example, a tongue-and-groove connection as is known in the art. Cartridge connection feature and cartridge carrier can 'set., C.om

<img file="MX355019B_D0012.tif" />

separate that are connected or be a unified component.

The autosampler may further comprise certain optional components such as, for example, a cartridge sensor and a patient sensor, which are described further below.

The motor may be an electric motor that is coupled to, and powered by, the power source. The power source may be, for example, a disposable battery or a rechargeable battery. The motor, drive control mechanism, and other components of the autosampler can be employed to provide the force required for multiple injections over an extended period of time. A commercially available electric motor with forward and reverse output shaft rotation can be used with a programmable controller, such as a microprocessor, to control the steps of operation required to perform drug injection and retraction of the needle and / or The syringe.

The reusable autoinjector could be adapted for use with any type of retractable or safety syringe, but for simplicity, the invention is described when using a syringe similar to those sold by the owner and assignee of the present invention under the trade name Unifill. Because the components of the

V&gt; ;, ....

Autosampler and the 'control- ^ sa ^ and drive mechanism are capable of repeatedly loading, injecting, and ejecting drug cartridges for injection of drug treatments to a patient, they are considered reusable autosamplers.

In another embodiment, the present invention relates to the method for manufacturing automatic injectors. The method includes the steps of mounting a drive control mechanism, which includes a drive drive screw, a plunger carrier, a cartridge carrier, and one or more control transfer instruments. The drive control mechanism may further include a guide having one or more guide recesses, one or more recesses in the plunger carrier, and one or more channels within the cartridge carrier. One or more control transfer instruments may, for example, be a spherical ball, cylinder, disk, or particle, or similar instruments that can move freely between the other components of the drive control mechanism, but are preferably cylindrical discs. These components are dimensioned and configured such that the control transfer instrument is retained within the drive control mechanism and guide. For example, the cartridge holder may be a thin object that has holes

X- · 1 · Ύ *: τ. · ..? -í ¿Yí &lt;v rectangular through the same as^p¿c ^ a ~ a3ié's transfer instruments may reside within the channels, but would be prevented from moving laterally along the axial plane of the carrier, since they are retained on all four sides. The dimensions of the transfer instruments are such that the transfer instruments are always removably coupled with two components of the drive control mechanism and / or the guide simultaneously. The .0 method further includes the step of attaching a guide and housing to the drive control mechanism. The method may further include the steps of attaching one or more of: a power source, a motor, a transmission mount, and a control system such as a microprocessor, where the .5 mount of the transmission is done. to contact the drive drive screw. An injector or cartridge cover can also be attached to the autosampler to facilitate loading and ejecting the cartridges.

&gt; 0 In yet another embodiment, the present invention relates to a method of use for an automatic injector.

The method includes the steps of: inserting a cartridge into a cartridge holder contained in an autosampler housing, and activating the autosampler to optionally start one or more of:

removal of a needle shield, injection of urpha'-y- ^ güj / to the patient, delivery of the drug through the needle to the patient, retraction of the patient's needle into the housing, and removal of the cartridge from the cartridge carrier . Additionally, optionally, the method of use may include the step of sending a portion of the drug dosage to a reservoir or other environment, prior to injection of the needle and delivery of the drug dose to a user, in order to reduce or adjust the volume of the drug. The method may further include the steps of opening a cartridge cover to access the interior of the autosampler before inserting a cartridge into the cartridge holder, and the step of closing the cartridge cover after the cartridge has been removed. has loaded into the cartridge carrier. The method may similarly include the step of opening the cartridge cover to access the interior of the autosampler after retraction of the needle to remove the used cartridge. The user can optionally assemble the needle shield to the cartridge after the syringe has been used (i.e. drug delivery has been terminated). After the used syringe has been removed from the autosampler cartridge carrier, the autosampler resets and is ready to accept another cartridge.

- 01/01 / 0¾ and details e0 a few possible inventions; other variations this document

The embodiments shown describe only similar variations of the present are contemplated and incorporated within the scope of this description.

As will be readily appreciated by someone with ordinary experience, various parameters, shapes, and dimensions described above can be modified while remaining within the scope and scope of the present invention.

An autosampler is adapted to receive a cartridge that includes a cylinder, a needle, and a plunger mount, which includes a plunger seal.

The cartridge defines a longitudinal axis.

The autosampler includes a housing, a cartridge holder, and a plunger holder. The cartridge holder is adapted to receive at least a portion of the cartridge. The cartridge holder is positioned for movement relative to the housing in a direction parallel to the longitudinal axis of the cartridge. The piston holder is positioned for movement relative to the cartridge holder.

The plunger carrier is positioned to confront and impart movement to at least a portion of the plunger mount.

At least one transfer instrument is placed to selectively couple the cartridge carrier to the plunger carrier for movement therewith. An elongated drive device is attached to the plunger carrier.

elongated drive movement of the carrier to the longitudinal axis of the

<img file="MX355019B_D0013.tif" />

It is positioned to provide the piston in a cartridge parallel direction.

One method of operating an autosampler to inject fluid from a cartridge, includes placing the cartridge in the autosampler with at least a portion of a cylinder positioned within a cartridge holder, and a plunger assembly positioned for confrontation with a plunger carrier, one end of the cartridge needle defining a distal end of the autosampler and the opposite end of the cartridge defining a proximal end of the

<td>injector</td><td>automatic,</td><td>couple</td><td>the</td><td>carrier</td><td>of the</td><td>cartridge al</td>

<td>carrier</td><td>of the plunger,</td><td>use</td><td>a</td><td>mechanism</td><td>of</td><td>actuation</td>

<td colspan="2">unique to move the</td><td>carrier</td><td>of the</td><td>plunger and</td><td>the</td><td>carrier of</td>

<td>cartridge</td><td>to make</td><td>move along</td><td>the</td><td>cartridge</td><td>in</td><td>one direction</td>

axially to the distal end, disengage the cartridge carrier from the plunger carrier, use the drive mechanism to move the plunger carrier in the axial direction toward the distal end to distribute the fluid, and retract the plunger carrier in an axial direction towards the proximal end.

One method of operating an autosampler includes placing a first cartridge in an autosampler housing, actuating the autosampler to distribute fluid from the first cartridge.

Λ ¡íi&gt; i rétTiiiiiir

<img file="MX355019B_D0014.tif" />

cartridge from the housing, place a second cartridge in the housing, and operate the autosampler to distribute the fluid from the second cartridge.

BRIEF DESCRIPTION OF THE DRAWINGS

The following non-limiting embodiments of the invention are described herein with reference to the following drawings, wherein:

<td></td><td colspan="2">The figure</td><td>1 shows a</td><td>isometric view</td><td>of the</td>

<td> 0</td><td>injector</td><td>automatic</td><td>reusable,</td><td>in accordance with</td><td>a</td>

<td></td><td>modality,</td><td>with a</td><td>cover the</td><td>optional cartridge</td><td>of the</td>

<td></td><td colspan="2">closed accommodation and</td><td colspan="2">the injector ready for operation.</td><td></td>

<td></td><td></td><td>The figure</td><td>2 shows a</td><td>isometric view</td><td>of the</td>

<td></td><td>injector</td><td>automatic</td><td>reusable,</td><td>in accordance with</td><td>a</td>

<td> 5</td><td>modality,</td><td>with a</td><td>cover the</td><td>optional cartridge</td><td>of the</td>

<td></td><td colspan="2">open accommodation</td><td>to the charge</td><td>of a cartridge</td><td>the</td>

j eringa.

Figure 3 is a fragmentary view of a distal end of a reusable autosampler with the cartridge cover&gt; 0 in a closed position.

Figure 4 is an exploded isometric view of a housing and aspects of a drive control mechanism according to one embodiment.

Figure 5 shows an isometric view of the bottom of a reusable autosampler in accordance with the embodiment shown in Figures 1-5.

Figure 6 shows an isometric view of the components of the drive control mechanism, motor, and transmission assembly according to an embodiment of the present invention.

Figures 7-8 show top and bottom views, respectively, of the components shown in Figure 6.

Figure 9 shows an isometric view of the cartridge holder of the drive control mechanism, in accordance with an embodiment of the present invention.

Figures 10A-10E show expanded views of the components of the reusable autosampler drive control mechanism, in accordance with the mode shown in Figures 11-15, as you progress through the steps of: loading the syringe cartridge removal of the rigid needle guard, injection of the needle, delivery of the drug dose, and retraction of the needle.

Figure 11A is a side view of the reusable autosampler, in accordance with an embodiment of the present invention, shown in the syringe cartridge loading configuration.

Figure 11B is a top view of the injector

<img file="MX355019B_D0015.tif" />

INjT ,,

<img file="MX355019B_D0016.tif" />

'Jt ιΛ Η,' .. ···;: -.! .., reusable automatic shown in Figure llAM ^¹··¹Figure 12A is a view of the strawberry tree dol —- Layert nr.

reusable automatic, in accordance with an embodiment of the present invention, shown in the needle guard removal configuration.

Figure 12B is a top view of the reusable autosampler shown in Figure 12A.

Figure 13A is a side view of the reusable autosampler, in accordance with an embodiment of the present invention, shown in the injection configuration.

Figure 13B is a top view of the reusable autosampler shown in Figure 13A.

Figure 14A is a side view of the reusable autosampler, in accordance with an embodiment of the present invention, shown in the drug delivery configuration.

Figure 14B is a top view of the reusable autosampler shown in Figure 14A.

Figure 15A is a side view of the reusable autosampler, in accordance with an embodiment of the present invention, shown in the syringe / needle retraction configuration.

Figure 15B is a top view of the reusable autosampler shown in Figure 15A.

T X. V -. \

i ...

views an-

The figures

16A-16B are

<img file="MX355019B_D0017.tif" />

sides of the housing, which includes -ιηοΰΙ * · 1ί'άΑά_ι._ι. da ... -ua cartridge ejector in the loaded and unloaded positions, respectively.

Figure 17 is a side elevation view of an alternate embodiment of an automatic injector in accordance with the invention.

Figure 18 is an enlarged, fragmented view of the components of the drive control mechanism of Figure 17.

Figure 19 is a bottom view of another embodiment of an automatic injector according to the invention.

Figure 20 is a top plan view of another embodiment of an automatic injector according to the invention.

Figure 21 is a top plan view of another embodiment of an automatic injector according to the invention.

The

Figures 22A-22E are side elevation views of a housing illustrating a cartridge cover release security mechanism in accordance with aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION 'Μζ

The modalities of or &lt;.

INSTiiU '! .. · ~ .A

DE LA j ·? ·, - \. '··· ^' this - They are related to devices for

<img file="MX355019B_D0018.tif" />

the drug supply.

The components of automatic injection devices are configured for repeatable functionality, and automatic injectors are designed to accept a variety of drug containers, such as syringes, and cartridges. For the purposes of this description, the term cartridge will generally refer to syringes, which include a plunger rod for delivery of a drug from a cylinder by movement of a plunger seal, and cylinders containing the drug that do not include a plunger rod for activation of a plunger seal.

The automatic injectors of the present invention may be single-use devices, but are preferably used as reusable automatic injectors. More specifically, the embodiments of the present invention relate to electromechanical automatic injection devices, which use motor-driven drive mechanisms, incorporating replaceable injection syringes, and perform one or more of the steps of: preparation and alignment of a cartridge for injection, removal of a safety cap or needle protection, injection of the needle, delivery of the drug dose, and retraction of the syringe and / or i /¹ .

/^1,...... ϊ ¹ '2./·^

The novel incorporation of the Se mechanisms

<img file="MX355019B_D0019.tif" />

Drive control on the injectors a ^ rtamáV'tCtTS — Cte '”Ta · present invention, allows a single engine and transmission assembly to operate the function of multiple components, thus simplifying the functionality of the device and improving reliability, operation and manufacturing cost of the reusable autosampler. The present invention also relates to actuation mechanisms for automatic injection devices, methods of making such devices, and their methods of use. In addition, optionally, the autosampler can be configured to adjust the dose volume, such as sending a portion of the drug dosage to a reservoir, prior to injection of the needle and delivery of the drug dose to a user.

As used herein to describe the drive mechanisms, autosamplers, cartridges, or any other relative positions of the components of the present invention, the terms "axially or axially" generally refer to a longitudinal A-axis around which the Reusable autosampler is preferably positioned, although not necessarily symmetrical around. The terms proximal, posterior, rearward, rearward, or rearward generally refer to an axial direction in the direction of the plunger rod ir Ά «· and ·. · ¡,. · ...

the montage'·

<img file="MX355019B_D0020.tif" />

transmission. The distal terms, fr ^ atet_r ,, -hagla · ..

forehead, depressed or forward, generally refer to an axial direction in the direction of the needle or rigid needle guard. The term laterally refers to a direction in a plane normal to a longitudinal axis A. The term radial generally refers to a direction normal to axis A.

As used herein, the term glass should be understood to include other similar non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass. The term plastic can include both thermoplastic and thermosetting polymers.

Thermoplastic polymers can be softened back to their original condition by heat;

thermosetting polymers do not.

As used herein, the term "plastic" primarily refers to moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, which typically also contains other ingredients such as curing agents, fillers, bonding agents reinforcement, colorants and / or plasticizers, etc., and which can be formed or molded under pressure and heat. As used herein, the term plastic does not include glass or

<img file="MX355019B_D0021.tif" />

<img file="MX355019B_D0022.tif" />

INSTITUTO MEXICANO OBLA PROPERTY elastomers that are approved for uTYT ^ árs (? Sn applications where there is a contact dilester '· with ¹ · therapeutic fluids that can interact with the plastic or that can be degraded by substituents that could otherwise enter the liquid in the plastic. The term elastomer, elastomeric or elastomeric material, primarily refers to crosslinked thermosetting rubbery polymers, which are more easily deformable than plastics, but which are approved for use with pharmaceutical grade fluids, and which are not readily susceptible to leaching or migration of the gas.

Fluid refers primarily to liquids, but may also include suspensions of solids dispersed in liquids, and gases dissolved in, or otherwise present along with the liquids within the fluid-containing portions of the cartridges. The terms drug, medicine and medicament, are used to refer to any substance that is administered from a cartridge through a needle or cannula, and is not limited to pharmaceutical substances, but may include, for example, vitamins or minerals.

As used herein, the terms auto injector and autoinjector are intended to refer to the same reusable devices, which may also be referred to by their acronym RAI. Disc is i ν &lt;Λ · - '.

⁷· _.A \ used in this document to describe a.

of the drive control mechanism, but the term is not limited to such shape, and in one or more embodiments of the present invention, it may be a spherical ball, cylinder, cone, and other functional shape that can be freely moved when driven by one or more adjacent surfaces.

Turning first to Figures 1 and 2, an automatic injector 50 according to the invention is shown. Autosampler 50 includes a housing 52 adapted to receive and support a syringe or cartridge 54 for injection, as well as various components of the injection system. A variety of cartridges 54 can be used in the reusable autosampler 50 of the present invention, including those having characteristics of

<td>retraction</td><td colspan="2">automatic.</td><td>For example,</td><td>a syringe</td><td>of</td>

<td>security</td><td>with</td><td>retraction</td><td>integrated</td><td colspan="2">the needle can</td>

<td>be used</td><td>with</td><td>the injector</td><td colspan="2">reusable automatic 50.</td><td>A</td>

<td>example of</td><td>such</td><td>cartridge 54</td><td>in the way</td><td>from a syringe</td><td>of</td>

Safety is illustrated in Figure 2 and Figures 11A-15B, and includes a cylinder 56, a needle 58, a rigid needle guard 60, and a plunger mount 62 that includes a plunger seal 64, a dipstick plunger 66, and a plunger head 68. Cartridge 54 includes a longitudinal axis A.

In the illustrated embodiment, cylinder 56 of cartridge 54 includes an enlarged finger lip

<img file="MX355019B_D0023.tif" />

70, such ..: As-.jeÍdi ^ ¿E ^ is commonly used in standardized 56 cylinder designs. Cartridge 54 can be pre-filled with a drug or filled upon use by a user, that is, just prior to placement within reusable autosampler 50. Alternate embodiments of the cartridges 54 may include, by way of example only, cartridges 54 which have a cylinder 56 sealed by a piston seal 64, but which do not have a piston rod 66 (see, eg, Figure 21 and the following explanation).

Housing 52 may optionally be covered by a cartridge cover 72, which may likewise be of any appropriate design. In order to allow the user to see the status of the cartridge 72 of the automatic injector 50, the cover may be totally or partially translucent or transparent.

Alternately, it can be totally or partially opaque.

The cartridge cover of the

Figures 1 and 2 include a window that is positioned substantially adjacent to cylinder 56 of a supported cartridge, allowing the user to view the status of drug delivery. Optionally, window 74, the portion of the cartridge cover adjacent the window, may have dose indication markings to allow the user to identify the dose volume.

T 7 '£

. - s&gt; ·· .... L. - before, during and / or the drug contained in cartridge 54 after drug delivery.

In the illustrated embodiment, the cartridge cover is hinged to the housing

52, although an alternative arrangement may be provided. For example, the cartridge cover or housing may include matching protrusions the other of the cartridge cover 72 or the housing may include ratchets for receiving the protrusions.

Such protrusions and pawls can be provided alone, or in conjunction with a hinge arrangement, and can be provided at any appropriate location between housing 52 and cartridge case 72. In such an embodiment, as shown in Figure 3, a distal pawl 76 with a matched protrusion 78 can be placed at, or substantially close to, the distal end of autosampler 50, to ensure that the distal end of cartridge cover 72 is held rigidly with respect to housing 52, and providing a secure seal along substantially the entire contact surface between cartridge cover 72 and housing 52. Although the housing 52 and the cartridge cover 72 can be formed as separate components, the cartridge cover 72 and the housing 52 can be alternately formed as a single unit, coupled to a so-called live joint (not shown).

J 'and? - V ______, -J

The autosampler 50 can iriclui-r &lt;-adémis-Hlh body of the casing 80, which provided x -., Un.a, ^_TOap¿UÍd. &amp; cic.ia · ,. smooth outer to housing 52. Housing body 80 may be formed as a separate structure from housing 52, having an internal chamber receiving housing 52, or housing 52 and housing body 80 may be formed as a single unit . It will be appreciated that when the autosampler 50 includes a cartridge cover 72, the cartridge cover 72 can be coupled to the housing 52 by means of the housing body 80. That is, the cartridge cover 72 can be coupled to the housing body 80, which receives the housing 52. As with the housing 52 and the cartridge cover 72, the housing body 80 and the cartridge cover 72 can be formed from separately, or as a single unit, connected, for example, by a live link (not shown).

In the embodiment illustrated in Figures 1 and 2, the cartridge cover 72 is held in a closed position on the housing 52, by means of a selectively operable latch 86. In the illustrated embodiment, the cartridge cover 72 includes a protrusion 88 which is received by a recess 90 in the housing 52. A latch release 92 can be slid to the side or depressed to allow the cartridge cover 72 to be secured to, or Unlock the housing 52.

Tf&gt; 'I ··

J.

I instituted c

L&gt; 2 LA IT.'J

<img file="MX355019B_D0024.tif" />

-A '&gt;

INDUSTRIAL

Autosampler 50 may further include a user interface 96 with features "such" as a release actuator 98, which can be depressed to initiate operation of autosampler 50 or the selection of other operational features.

Other operational features may include, by way of example only, an identification of the settings based on the here 58 used in cartridge 54, or the volume of the drug carried in cartridge 54 and the volume to be dispensed, and will be explained further detail below. Autosampler 50 may further include one or more lights 100, or the like, indicating the operating status of autosampler 50.

Housing 52 may be of any appropriate design, and may be formed as a unitary structure, or may include a plurality of components. Referring to Figures 4 and 5, housing 52 is an elongated frame 102, adapted to removably support a cartridge 54 along an upper surface or along a structure associated with housing 52. Housing 52 may further support one or more of the structures associated with the operation or use of autosampler 50. More specifically, in the embodiment illustrated in Figure 5, housing 52 further supported by a drive control mechanism 104 which controls the movement of

Τ '. ...

ί.^;Λ INST'i 7,. ..... the components of the cartridge 54 within the year of my life ^ S? '. The drive control mechanism TÜ? 7 - which will ~ be described in greater detail below, can be operated by a motor 106 powered by a power source 108. Although the motor 106 and power source 108 are illustrated as are supported in housing 52, could alternatively be supported alternately, eg, within a housing body 80. Power source 108 can be in several different configurations and in a variety of sources including, for example, disposable batteries, or rechargeable or reusable batteries. A transmission mount 110 couples the rotary motion of engine 106 to drive control mechanism 104.

The reusable autosampler 50 may also contain certain standard features such as, for example, one or more control systems, such as a microprocessor (not specifically illustrated), can be used to control the timing and operating parameters of the autosampler. fifty. The operation of the control systems may optionally be based on feedback from one or more sensors, or input received from the user via the user interface 96. For example, the automatic injector 50 may include features that are associated with closing the cartridge cover 72 to the housing 52, or the position of

<img file="MX355019B_D0025.tif" />

iiMS Tí IJ · '. : ΌΚ Í.A r λ. '; .-; , release of the lock 92. In order to redlSei'h'the opportunity for an inadve ^ 4r4-4 © —dal · —í.nyec.t, p, r automatic drive 50, an optional sensor can be used to signal whether cartridge cover 72 is open or closed, allowing a control system associated with autosampler 50, to prevent actuation if cartridge cover 72 is not closed. Similarly, the structure of the automatic injector 50 or the control system can be designed to prevent opening of the cartridge cover 72, that is, the movement of the latch release 92, unless the internal components are in one or more particular positions.

The microprocessor can be configured to receive feedback from individual sensors, and cause some activity from engine 106 and transmission mount 110, based on variable feedback from one or more sensors. The attached figures exclude such control systems, since several different systems or configurations can be used, but a control system should be understood as being optionally included. The control system, as will be readily appreciated by someone having ordinary skill in the art, would accept some user activity at one or more system controls, and interpret such activity by the user to activate the features of the reusable autosampler 50. In

<img file="MX355019B_D0026.tif" />

<img file="MX355019B_D0027.tif" />

DL ι „. - --''- Ά at least one modality, the control system - esuiim microprocessor located in the ext-a-emo - next! auto injector 50, adjacent to transmission mount 110 and user interface 96 (shown in Figure 2-10E).

In accordance with one aspect of the embodiments of the invention, the autosampler 50 provides the predictable motion for actuation of a loaded cartridge 54. In some embodiments, the autosampler 50 provides repeatable motion, so that the autosampler 50 can be used repeatedly with a plurality of cartridges 54. In order to inject a patient, autosampler 50 proceeds through a plurality of steps including movement of needle 58 into target tissue, and administration of an injection by movement of plunger seal 64.

In order to provide longitudinal movement of the components of the cartridge 54 relative to the housing 52, the housing 52 supports the drive control mechanism 104, which interfaces with the motor 106 via the transmission mount 110. The Transmission 110 may have various configurations that allow movement and power to be transferred from engine 106 to drive control mechanism 104. An exemplary transmission mount 110 is shown in greater detail in Figures 5-8.

<img file="MX355019B_D0028.tif" />

<img file="MX355019B_D0029.tif" /> '' I · '. : '' 9 λ / · - · · -. &lt;“&gt; • 4-0 ''

Figures 7-8 show the computations of the drive control mechanism cTT0ⁿ4 — and — the ment-aje-— · of transmission 110 illustrated in the isometric views of Figures 5-6 from the top and bottom viewing angles. The transmission assembly 110 includes a gear train 112, which transmits the rotary motion of the motor 106 to an elongated drive device, here, a drive drive screw 114, which interfaces with the drive control mechanism 104. The elongated drive device, here, the drive screw 114, is positioned to impart movement to at least a portion of the plunger assembly 62, via the drive control mechanism 104. The drive control mechanism 104 will be described in more detail below.

It will be appreciated that gear train 112 can have various configurations allowing it to transfer motion and energy from motor 106 to drive screw 114. For example, gear train 112 may be a single gear or a pair of bevel gears that they transfer the motion of a motor 106 to a drive screw 114. Referring to Figures 5-8, in particular, in at least one embodiment of the present invention, the transmission assembly 110 includes a pinion gear 116 connected to the engine 106, a gear

<img file="MX355019B_D0030.tif" />

Τ 5 5 ~ 5 &lt;&lt; ......

ί 55 * '? ν.&gt;' ·; η;, 5. '' ', · \ compound 118, and a drive gear 120 ·. ·' „E1. Composite enqraw '118 may have a surface of the ... primary gear 122 that engages the pinion gear 116, and a surface of the secondary gear 124, which engages the drive gear 120. The drive gear 120 is connected to the drive screw 114. It will be appreciated that as the motor 106 rotates the pinion gear 116 in a clockwise direction, for example, the teeth of the pinion gear 116 engage the teeth of the primary gear surface 122 of the compound gear 118 , by rotating the compound gear 118 in a counterclockwise direction. As a result, the teeth of the secondary gear surface 124 engage with the teeth of drive gear 120 to rotate drive gear 120, as well as drive screw 114 connected in a clockwise direction of the watch.

This configuration of the transmission mount 110 allows the movement of the motor 106 to control the movement of the drive screw 114 in a way that minimizes the internal volume of the automatic injector 50, because both the engine 106 and the drive screw 114 can be placed in axial alignment. As will be readily appreciated by someone with experience, the movement of the 'ádcí-Onálftí ^^ Ó 114 screw by the transmission mount 110 - e® — eau &amp; aóte — pur la, interaction between the gear mounting teeth of the transmission transmission 110. The teeth of one or more of these gears may be radial with the center point of each gear, commonly referred to as toothed gears or by the number of other types of gears known to someone having ordinary experience in the art.

<td></td><td>A</td><td>mechanism</td><td>of</td><td>control of</td><td>actuation</td><td> 104</td>

<td>copy</td><td colspan="2">shown with</td><td>plus</td><td>detail in</td><td>Figures 6-9.</td><td>The</td>

<td>mechanism</td><td>of</td><td>control</td><td>of the</td><td>actuation</td><td>104 includes</td><td>a</td>

<td>carrier</td><td>of the</td><td>cartridge</td><td> 126,</td><td>a carrier</td><td>plunger</td><td> 138</td>

<td>placed</td><td>for</td><td colspan="2">provide</td><td>the movement</td><td>longitudinal</td><td>with</td>

<td>relationship</td><td colspan="4">cartridge holder 126, and</td><td>an instrument</td><td>of</td>

<td colspan="2">transfer</td><td colspan="2">150 placed</td><td colspan="3">to control movement</td>

<td>relative</td><td colspan="4">between the piston holder 138</td><td>and the carrier</td><td>of the</td>

<td>cartridge</td><td> 126.</td><td></td><td></td><td></td><td></td><td></td>

Cartridge holder 126 includes an elongated frame 128 having a connection feature of cartridge 130. In the illustrated embodiment, elongated frame 128 includes a pair of rails 132 with cartridge connection feature 130 positioned at a distal end of the themselves. The connecting feature of cartridge 130 is adapted to interfere with, and support the proximal end of cylinder 56 of cartridge 54. In the illustrated mode, the connection characteristic of it. &lt;cartúr-abSÍ ^ 30 includes an internal channel 134 adapted to receive ..... the flange for the enlarged finger 70 of the cartridge 54. The connection feature of the cartridge 130 may include, for example, a tongue-and-groove connection or any other removable coupling connection features known in the art. It will be appreciated by those skilled in the art, that alternate engagement can be provided in the illustrated position or in an alternate position, provided that movement of the cartridge holder 126 in the proximal or distal direction results in corresponding movement of the cylinder 56 of the cartridge 54.

In order to provide movement of the cartridge 54 to facilitate, for example, insertion of the needle 58 into the target tissue, the cartridge holder 126 is mounted for axial movement relative to the housing 52. In the illustrated embodiment, the Housing 52 includes a pair of longitudinally extending rails 136 along which the elongated frame 128 of the cartridge holder 126 is displaced. It will be appreciated, however, that relative axial movement can be facilitated by any appropriate structural arrangement. Thus, during one or more stages of operation of the autosampler 50, such as insertion and removal of a needle 58 from the target tissue, the cartridge holder 126 can move

IM '

,.&gt; k: .Λ: -L

114 i. ' the cylinder 56 of the loaded cartridge 54 proximally or distally relative to the allo j amiSTÍtd 5'2 '.'

To allow the control mechanism to administer a drug, drive 104 provides longitudinal movement of piston seal 64 within cylinder 56 of cartridge 54.

In the illustrated embodiment, the drive control mechanism 104 includes a plunger holder 138 that receives the plunger head connected to the plunger rod 66. The plunger holder

138 illustrated, includes interconnect feature

140 confronting at least a portion of a proximal end of the plunger mount 62, here, this way, movement of the distal direction, causes the plunger head 68.

Plunger Carrier 138 Plunger Head 68 and Plunger Rod 66 cause Plunger Seal 64

From there move in a distal direction into cylinder 56 to administer a medication.

Returning to the mode illustrated in Figures 6-8, for dispensing the drug from the cartridge 54, the plunger carrier 138 is mounted such that the operation of the motor 106 by mounting the transmission 110 and a drive screw

114, results in longitudinal movement relative to the housing

52.

As can best be seen in the Figure

4, the plunger carrier 138 includes an internally threaded hole 142 which is

COMPLEMENTARY MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY with externally threaded drive screw 114. In the illustrated embodiment, the internally threaded hole 142 extends through a portion 144 of the piston holder 138, which is positioned between the rails 132 of the cartridge holder 126, such that a base 146 of the piston holder 138 is displaced along an upper surface of rails 132, while portion 144 travels between rails 132.

As the drive screw 114 rotates, the plunger carrier 138 moves in a longitudinal direction the drive screw depending on the direction of rotation of the

114, as well as the configuration of the threads of the externally threaded drive screw

114 and in the internally threaded hole

142 .

The interaction and rotation of the gears of the gear train

112, driven by motor 106, drives the operation of the autosampler as the drive screw rotates

114 .

the illustrated threaded configuration and observing the autosampler from the proximal end, clockwise rotation of the motor 106 causes the drive screw 114 to move the plunger carrier

138 of injector 50 in the proximal direction relative to housing 52 as drive screw 114 rotates in a clockwise direction;

<img file="MX355019B_D0031.tif" />

Conversely, counterclockwise rotation of the motor 106 causes the drive torque 114 to rotate in a counterclockwise direction to move the piston carrier 138 in the distal direction. in relation to accommodation 52. If the drive screw 114 and the internally threaded hole 142 of the plunger holder 138 each have a thread configuration opposite to that illustrated, the direction of movement of the plunger holder 10 in the proximal or distal direction relative to the housing 52 would be the opposite.

In other words, the operation of the motor 106 rotates the drive screw 114 by means of the transmission mount 110, and the rotation of the drive screw 114 moves the piston carrier 138 in the longitudinal direction within the housing 52. In the In the illustrated embodiment, this movement of the piston holder 138 is probably used to provide selective longitudinal movement to the cartridge holder.

126, to allow movement of needle 58 in and out of the target tissue. In order to transmit this movement from the plunger holder 138 to the cartridge holder 126, one or more transfer instruments 150 are provided. As will be explained in greater detail below, the transfer instrument 150 can be selectively moved between a r^: · 'R; '1M&gt; · i ·. · ..... ··

Ot bA r&gt; · - · *. ·&gt; * * Pr ime PáH-'po's ic

<img file="MX355019B_D0032.tif" />

where the transfer instrument 15Δ —— only joins —et + cartridge holder 126 or piston holder 138, and a second position where transfer instrument 150 couples both cartridge holder 126 and piston holder 138, in effect , connecting cartridge holder 126 and plunger holder 138 together, for contemporary movement.

To provide this selective coupling, transfer instrument 150 is movably positioned within channel 152 of cartridge holder 126 (see Figure 9). Transfer instrument 150 is adapted to move laterally, partially within pawls or recesses 154, 156 in plunger carrier 138 and longitudinally extending rail guides 158 of housing 52, respectively.

Thus, when the transfer instrument 150 is placed within the channel 152 of the cartridge carrier 126 and the recess 154 of the piston carrier 138, the cartridge carrier 126 will engage the piston carrier 138 for movement with the carrier. piston 138 along actuation screw 114. Conversely, when the transfer instrument 150 is placed within the channel 152 of the cartridge holder 126 and the recess 156 of the guide 158, the cartridge holder 126 will not move with the piston holder 138;

in its

OOl place '^¹ DÉéftü íát »

IHUUÜímAL

<img file="MX355019B_D0033.tif" />

illustrated, cartridge holder 126 will not move relative to housing 52.

It will be appreciated by those skilled in the art that each of recesses 154, 156 and channel 152 could be described as openings. Furthermore, it will be appreciated that although transfer instrument 150 is described herein as moving between a first position within channel 152 of cartridge holder 126 and recess 156 of guide 158 to a second position within recess 154 of plunger carrier 138 and channel 152 of cartridge carrier 126, in an alternate mode, transfer instrument 150 could be positioned for movement between a first position within plunger carrier recess 154 138 to a second position within plunger carrier recess 154 138 and cartridge holder channel 152 126.

Furthermore, although transfer instrument 150 can be described as being positioned or coupled in channel 152 and one or the other of recesses 154, 156, transfer instrument 150 may be slightly larger than channel 152 and one or the other of rebates 154, 156 combined. For the purpose of this description and the appended claims, however, when the transfer instrument 150 is described as being positioned or coupled to one or the other first and the second terminology encompasses one of the

<img file="MX355019B_D0034.tif" />

position, it will be understood that the structural relationship, where the transfer instrument 150 is predominantly positioned in one way or another, such that the associated structures are coupled substantially together.

That is, when transfer instrument 150 is positioned predominantly within channel 152 and recess 154, plunger carrier 138 and cartridge carrier 126 are coupled together; conversely, when transfer instrument 150 is positioned predominantly within channel 152 and recess 156, cartridge holder 126 and guide 158 are coupled together.

For clarity, Figures 10A-10E show the components of the drive control mechanism 104, and their relative positions as they move during the drive steps of the autosampler 50. The illustrated embodiment includes two control transfer instruments, specifically, two transfer instruments 150 moving through respective channels 152, in cartridge holder 126 between respective recesses 154, 156 in piston holder 138 and guides 158.

Although transfer instruments 150, channel 152, and recesses 154, 156 may be of any appropriate design in the illustrated manner

INSTITUTE 5 /,:. 2 .. ·. .. t.'i

CE LA ÍROPÍEDAO, „, and, los'^fJTransfer 1'fi§TrurtfeTTtt5s 150 are in the form of a — ei-Í-ind ^ o&gt; diaeo or puck, allowing you to move smoothly within channel 152. In addition, transfer instruments 150 can be of any suitable material. By way of example only, transfer instruments 150 may be formed of a polymer, stainless steel, or a silicone or rubbery material.

The dimensions of the transfer instruments

150 they are such that the transfer instrument is always removably coupled with at least two components of the drive control mechanism 104 simultaneously. In some stages of operation, each transfer instrument 150 is removably coupled to the corresponding recess 156 in guide 158 and channel 152 (visible in Figure 9) of cartridge holder 126. In other stages of operation, each transfer instrument 150 is removably coupled with the channel 152 of the cartridge carrier 126 and the recess 154 of the piston carrier 138. This novel configuration allows a single engine 106 and transmission mount 110, operate the multi-component function, thereby simplifying the functionality of the autosampler 50 and improving the reliability, operation, and manufacturing cost of the autosampler

<img file="MX355019B_D0035.tif" />

MEXICAN INSTITUTE OF INDUSTIUAL PROPERTY

<img file="MX355019B_D0036.tif" />

reusable 50. ____________

Similarly, recesses 154, 156 of plunger carrier 138 and guides 158 may be several of different configurations. In one embodiment of the present invention, recesses 154, 156 of plunger carrier 138 and guides 158 are symmetrical within the respective components. The recesses 154, 156 have an arcuate shape that is ramp-shaped on either side to facilitate movement of the transfer instrument 150 as the transfer instrument 150 moves along the ramp-shaped surfaces. In this way, at least a partially rounded outer surface of the transfer instrument 150 can smoothly move along the ramp-shaped surfaces.

The operation of transfer instruments

150 and the respective movements of the cartridge holder

126 and piston carrier 138, can be better understood with respect to exemplary steps of operation of autosampler 50. Figures 10A-10E and 11A-11B through 15a-b show the positioning of the components of an embodiment of the automatic injector 50 through the stages of loading the cartridge 54 (Figures 10A and 11A-11B), removal of the rigid needle guard 60 (Figures 10B and 12A-12B), injection of needle 58 (Figures 10C and 13A-13B), delivery of the drug dose (Figures 10D and 14A-14B), and retraction of the needle ( Figures 10E and iny ^ c ±_lor .., .. au_lt.QmáJJ..da., 5fl

HA, 12A, 13A, 14A and 15A show the from a side view (the lines in have been removed in the interest of the

Figures 11B,

12B, 13B,

14B and automatic 50 from one view

Transfer Amplified Figures 10A-10E 150

T '

15A-15gyl · · cross section is clarity), while the

15B show the upper injector in plan.

The fragmented top views show the with the piston carrier operation of the relation to the carrier

138 and guides 158.

cartridge 126 instruments,

For clarity, the plunger carrier 138 is removed below the base 146, illustrating only portion 144 of the plunger carrier

138 moving between the rails 132 of the cartridge holder 126.

A cartridge is replaceably inserted into a reusable autosampler cartridge holder 126 and held in place through the injection and retraction process of needle 58, as shown in the Figures.

11A-15B. Cartridge 54 may be held in place within cartridge holder 126, for example, by one or more cartridge connection features 130.

A cartridge 160 sensor placed inside the cartridge holder

126 can optionally be used to detect when a cartridge 54 has been placed inside the cartridge holder

126 of the

I - - -&gt; -,

x. INSTITUTE rr ;; -, :: j

DE LA HO'iro .-. D ζ injector '^{NUU!, R,}a'htd

<img file="MX355019B_D0037.tif" />

reusable 50. In cartridge 160 it is placed in illustra-ete ·? —- e4 — sensor da.l.

the bottom of the housing 52, although it can be placed in an altered manner. Placing cartridge 54 within cartridge holder 126 so that cartridge sensor 160 detects the presence of cartridge 54 can provide an indication that allows reusable autosampler 50 to activate.

The cartridge 160 sensor may be of any suitable design. For example, the cartridge sensor 160 may be a mechanical sensor, so that placing a cartridge 54 in the cartridge holder 54 causes displacement of the mechanical sensor. Alternately or additionally, the cartridge sensor 54 may be an electrical sensor.

In addition, the sensor drive for cartridge 160, either electrical or mechanical, can be coupled with an operation of autosampler 50, such that the sensor drive for cartridge 160, for example, allows the cartridge cover 72 to close and secure, or provide a signal to a processor, which enables actuation of the autosampler 50. Upon activation, the motor 106 may cause the transmission assembly 110 to drive the drive screw 114 in the correct position, where the interlocking feature of the plunger

<img file="MX355019B_D0038.tif" />

K &amp; s. ',.

0 of the bearer of the ém'QÓl.0,

<img file="MX355019B_D0039.tif" />

in contact with or adjacent to the proximal end of the piston rod 66 of cartridge 54.

In order to facilitate removal of the rigid needle guard 60, the autosampler 50 may include a structure that engages the rigid needle guard 60 so that movement of the cartridge 54 in the proximal direction results in removal of rigid needle guard 60. As can be seen in Figures 11A and 11B, cartridge 54 can be positioned so that the rigid needle guard 60, which covers needle 58 prior to injection for safety purposes, is removably secured in pull-out characteristics. the needle guard 162 of the support housing 52. The removal characteristics of the needle guard 162 may be of any suitable design. In the illustrated embodiment, for example, the removal features of the needle guard 162 include one or more flanges 164 positioned along a proximally positioned edge of a rigid needle guard 60. Thus, according to the flanges 164 face the rigid needle guard 60 during movement of the cartridge 54 in a proximal direction, the rigid needle guard 60 disengages from the distal end of the cartridge 54. Alternately, the reusable autosampler

<img file="MX355019B_D0040.tif" />

it can be configured such that the removals of the needle guard 162 from the support housing 52 are secured in the cylinder 56 between the cylinder 56 and the rigid needle guard 60.

The function of the drive control mechanism, its components, and autosampler 50 can be better understood with reference to Figures 4, 6-8, and 10A-10E, since they relate to Figures 11A-15B. In a first stage, typically for loading a cartridge 54 into the automatic injector 50, the components of the drive control mechanism 104 are shown in Figures 10A and 11A-11B. Guide 158 contains recess 156, while plunger carrier 138 similarly contains recess 154. As described herein, guide 158 may be a separate component or a preformed appearance of housing 52. Regardless of whether guide 158 is a separate component or preformed aspect of housing 52, it is considered as a part of housing 52 for the purposes of this description. Cartridge holder 126 contains at least one channel 152. The drive control mechanism 104 may include a recess 156 within the guide 158, a recess 154 within the piston carrier 138, and a channel 152 through the cartridge holder 126 for each control transfer instrument 150 used by the auto injector 50.

By

..- · '_ Λ * example, when using two instruments of' ^ transf'eí ^ n ^ fa of the disk-shaped control in the i n-¿»υi ~ nmátí m 5 0. as shown in the Figures 10A-10E, the drive control mechanism 104 includes two guide recesses 156, two plunger carrier recesses 154, and two channels 152 that are positioned and interact with the control transfer instruments 150, respectively. When the reusable autosampler 50 is in the first stage for loading the cartridge 54, the components of the drive control mechanism 104 are aligned so that each transfer instrument 150 is freely passed between the recess in the guide 156, through cartridge holder channel 152, 126, and plunger holder recess 154, as illustrated in Figure 10A.

To move the reusable autosampler 50 into a second stage, generally considered the stage for removal of rigid needle guard 60 from needle 58, the motor 106 and the transmission assembly 110 cause the components of the control mechanism of the drive 104 move in the proximal direction. This arrangement is shown in Figures 12A and 12B. Although the rigid needle guard 60 is retained at the distal end of the reusable autosampler 50, such as by interacting with the removal characteristics of the needle guard 162 from the support housing for example components

T &lt;.......- of the mechanism of ^ W

<img file="MX355019B_D0041.tif" />

drive 104 and cartridge 54 se .nn i ·. · h-í rpr-p-ί hr _ proximal. This action separates the rigid needle guard 60 from needle 58. In one embodiment, the rigid needle guard 60 can be configured to pop out of cartridge 54 so that the rigid needle guard can be ejected from the reusable autosampler if is desired. Cartridge 54 and autosampler

50, are now ready for injection into a patient.

The

Figure 10B further details the interaction of the components of the drive control mechanism.

104 as the autosampler moves from the loading stage (shown in Figures

There is

11B) to the stage of removal of the rigid needle guard (shown in the Figures

12A and 12B).

While guide 158, and consequently recesses of guide 156, is a component in a fixed position, the cartridge carrier

126, plunger carrier 138, and drive screw 114 are all moving components. In the transition from the loading stage to the removal stage of the rigid needle guard 60, the motor 106 and the transmission assembly 110 cause the drive screw 114 to rotate, so that the piston carrier 138 becomes it moves in the proximal direction, that is, from the respective positions illustrated in Figure 10A to the respective positions illustrated in Figure 10B. As plunger holder 138 moves back and cartridge holder channel 152 152 aligns '^' oñ Γ &lt;55

154 of the plunger holder 138, the transfer instruments 150 move inward, ensuring that the transfer instruments 150 are out of the recesses in the guide 156 and in position between the channels 152 of the cartridge carrier 126 and the recesses 154 of the carrier of plunger 138, as shown in Figure 10B.

When transfer instrument 150 is formed of a rubbery material and is slightly wider than the combined depth of channel 152 and guide recess 156, transfer instrument 150 will protrude slightly into recess 154 of plunger carrier 138, when recess 154 aligns with recess 156 and channel 152. As plunger holder 138 continues to move relative to guide 158, cartridge holder 126 may move slightly with plunger holder 138 as a result of the force of transfer instrument 150 driven by the ramp-shaped surface of the recess.

<td colspan="3">154 of the</td><td colspan="2">plunger</td><td> 138.</td><td colspan="2">The force</td><td>continuous of</td><td>the</td>

<td>surface</td><td>with</td><td>shape</td><td>of</td><td>ramp</td><td>of the</td><td>discount</td><td> 154,</td><td>the force of</td><td>the</td>

<td>surface</td><td>with</td><td>shape</td><td>of</td><td>ramp</td><td>of the</td><td>discount</td><td> 156</td><td colspan="2">at the address</td>

<td>opposite to</td><td>the</td><td>long</td><td>of</td><td colspan="2">a side</td><td>opposite</td><td>of the</td><td>instrument</td><td>of</td>

<td colspan="2">transfer</td><td> 150,</td><td colspan="2">create a</td><td colspan="2">moment</td><td>than</td><td>cause that</td><td>the</td>

transfer instrument 150 to move from recess 156 to

<img file="MX355019B_D0042.tif" />

<img file="MX355019B_D0043.tif" />

the guide 158 towards the recess 154 of the piston carrier 138.

With the placement of the transfer instrument 150 in the channel 152 of the cartridge holder 126 and the recess 154 of the piston holder 138, the cartridge holder 126 and the piston holder 138 are coupled together for further movement.

This positioning of the transfer instruments 150 causes the cartridge holder 126 and the plunger holder 138 to move as a unified component. That is, as rotation of drive screw 114 causes movement of plunger holder 138 in the proximal direction, placement of transfer instruments of control 150 with recesses 154 of plunger carrier 138 and channels 152 of plunger carrier Cartridge 126 couple cartridge holder 126 to plunger holder 138 so that cartridge holder 126 also moves in the proximal direction. In this way, movement of the plunger holder 138 and cartridge holder 126 in the proximal direction moves the transfer instruments 150 away from the recesses 156 in the guide in the fixed position 158.

As indicated above, one or more control transfer instruments 150 can be used in the drive control mechanisms and automatic injectors of the present invention. In at least one modality, however, r 7.1 Ό /

I

XXX .. ·. / Two instruments —-- give ^ transfer of control in the form of ί, Ι.Ι, Ζάΰ.

to, for example, provide stronger connections, a more even distribution of force across components, and control of component movement.

Because the needle guard 60 of the cartridge 54 is removably confronted by the removal characteristics of the needle guard 162 from the housing 52 (shown in Figures 11A-11B), the rigid needle guard 60 is withdraws from needle 58 by proximal movement of cartridge holder 126 and cartridge 54. This is shown in the transition between Figures 11A-11B and 12A and 12B, as well as the transition between Figures 10A and 10B. The reusable autosampler 50 can now be placed in contact with a patient's target tissue, to inject needle 58 and deliver a drug contained within cartridge 54.

Moving to Figures 13A-13B, during the injection stage, the cartridge holder 126 and the plunger holder 138 move in the distal direction, moving the needle 58 now exposed at the distal end of the reusable autosampler 50 into a position injection into the patient's target tissue. As further described herein, an optional patient sensor 165 (shown in Figures 1, 2, and 5), can be used to detect patient contact before

<img file="MX355019B_D0044.tif" />

the injection stage. The Borebore sensor can be placed on the distal end of the reusable autosampler 50, adjacent to, and on the outside of the needle shield removal feature 162 of the support housing 52. Upon contact with a patient, patient sensor 165 can signal to a control system that the patient is ready for injection, if one or more control systems are used to control timing and movement parameters. Alternately or additionally, Patient Sensor 165 can be mechanically coupled to an arrangement that prevents drug delivery from Cartridge 54 unless Patient Sensor 165 is depressed.

As the cartridge holder 126 and the plunger holder 138 move in the distal direction, the components move from the position shown in Figure 10B to the position shown at 10c. As shown in Figure 10C, in the position where needle 58 has been inserted into the target tissue, channels 152 are re-aligned with recesses 156 in guides 158. As a result, transfer instruments 150 are able to move freely between plunger carrier recesses 154, channels 152, and guide recesses 156. Transfer instruments 150 may be in the

<img file="MX355019B_D0045.tif" />

ΙΝΓΠΠΠΌMCXI -'f · '

D £ LA fWr'.i- 'Ai

INDUSTRIAL

<img file="MX355019B_D0046.tif" />

out position (ie, in recesses of guide 156) or in position (ie, in recesses of plunger carrier 154). As the cartridge holder 126 moves in the most distal position as illustrated in Figures 13A and 13B, however, the piston holder 138 continues forward movement as a result of rotation of the drive screw 114. With continuous movement of the plunger holder 138, the transfer instruments 150 move along the ramp-shaped edges of the recesses 154 of the plunger holder 138, propelling the transfer instruments 150 out through the channels 152 in the stationary cartridge carrier 126 and into recesses 156 in guides 158. In this way, the continuous movement of the plunger holder 138 causes the transfer instruments 150 to move along the ramp-shaped sides of the recesses 154 of the plunger holder 138, to move outward when the channels 152 of the cartridge carrier 126 are aligned with recesses 156 in guide 158, decoupling transfer instruments 150 from recesses 154 in piston carrier 138, for engaging transfer instruments 150 in recesses 156 in guide 158, that is, the position illustrated in Figure 10D. In the position of Figure 10D, the piston holder 138 is free to continue the

<img file="MX355019B_D0047.tif" />

forward movement to supply the, £ 4WScó&gt; ¿

Depending on the desired injection parameters, the drug can be delivered immediately after injection of the needle.

58, or there may be a momentary delay between the two stages.

Such parameters may be programmed into the control system or user initiated, as desired for the operation of the reusable autosampler 50.

For the drug delivery step, plunger holder 138 can continue to move in the distal direction, while cartridge holder 126 is temporarily locked in place with guide 158, as illustrated in Figure 10D. The securing occurs because the transfer instruments 150 are forced out of the recesses of the plunger carrier 154 and into a position between the channels 152 of the cartridge carrier 126 and the recesses of the guide 156 of the guide 158. As the carrier As the piston 138 continues to move in the distal direction, the interlocking feature of the piston 140 of the piston holder 138 applies a force to, or pushes the distal end of the piston rod 66. Plunger rod 66 transmits axial force in the distal direction to plunger seal 64 within cylinder 56 of cartridge 54, thereby propelling drug fluid through needle 58 and into the patient.

Through

<img file="MX355019B_D0048.tif" />

INSTITUTO MEXICANO Say THE INDUSTRIAL PROPERTY the supply stage as the components of the automatic injector 50, the transfer instruments 150 remain in the out position between the channels 152 and the recesses of the guide 156, as shown in Figure lOd. It will be appreciated, however, that as the plunger carrier 138 moves to the position illustrated in Figures 14A and 14B, the portion 144 of the plunger carrier 138 positioned between the guides 158, moves beyond the position where the Portion 144 causes interference that would prevent transfer instruments 150 from moving radially inward again, that is, out of recesses 156 in guides 158 and channels 152 in cartridge holder 126.

Although any appropriate arrangement can be provided to hold the transfer instruments 150 in place, in the illustrated embodiment, a catch 166 is provided. The catch 166 can best be seen in Figure

Four. By means of a deviation element of the detent 168, such as the illustrated spring, the detent 166 is positioned and deflected into a position that at least partially covers the channels 152 in the cartridge holder 126, when the piston holder 138 is moved distally to deliver a drug from cartridge 54. In this way, the deviation element of the detent 168 and the detent 166 are configured to retain the transfer instruments 150 within the channels 152 and the recesses of the guide 156

<img file="MX355019B_D0049.tif" />

For e is shown in Figure 10D, the element — do — Hfisvi anion. d§_l retainer 168 is placed at the proximal end of, and axially around drive screw 114 between the proximal end of cartridge holder 126 and the proximal end of plunger holder 138. Retainer deflection member 168 is initially in a compressed position, but is allowed to expand along the axis of drive screw 114 when plunger holder 138 has been moved distally. Retainer deflection member 168 acts on retainer 166 and moves the latter in the distal direction when the plunger carrier 138 has moved distally. As the plunger holder 138 moves in the distal direction along the axis of the drive screw 114 during controlled drug delivery, the retainer 166, driven distally by the retainer deflection member 168, functions to hold the instruments in place. transfer 150 into drive control mechanism 104.

In order to provide controlled movement and function of retainer 166 and retainer deflection member 168, cartridge holder 126 may include a structure to guide and limit movement of retainer 166. In the illustrated embodiment, a projection 170 includes two arcuate segments 172 that extend between rails 132

<img file="MX355019B_D0050.tif" />

INSTITUTE ΜΓΧΐΟΑΗΟ OF THE INDUSTRIAL EKOÉ'IEüAD

<img file="MX355019B_D0051.tif" />

cartridge holder 126 (see Figure 9). The arcuate segments 172 are separated by longitudinally extending channels 174, which slidably receive arms 176 which extend from retainer 166 (see Figure 4).

Arms

176 and / or channels 174 may include a structure, such as elongated ends 180 of arms 176, which limit movement of retainer 166 in a distal direction.

Those of experience will appreciate that structures, such as protrusions 170 can be formed unitary with cartridge holder 126, for example, or can be formed as one or more separate components.

After the drug delivery stage has been completed, as shown in Figures 14A-14B and Figure 10D, the drive screw 114 can be moved in the proximal direction by mounting the transmission 110 and motor 106, that is, for example, to the position illustrated in Figures 15A-15B and Figure 10E. Since drive screw 114 causes movement in the proximal direction of plunger holder 138, such as rotation of drive screw 114 in the reverse or opposite direction of its previous movement, plunger holder 138 engages retainer 166 to return retainer 166 to its original position, again compressing retainer deflection member 168 to the position shown in Figure

<img file="MX355019B_D0052.tif" />

10E. As they move in a

JL ... CVY

Say LA 'the seal 166 and the bearing of the proximal direction plunger, at the drive screw 114, the transfer instruments

150 they are again allowed to move between the guide recesses 156 and the channels 152 in contact with the piston recesses 154. Once this occurs, the cartridge holder 126 also moves in the proximal direction. The movement of the piston holder

138 and the cartridge holder 126 in the proximal direction, moves the transfer instruments 150 away from the recesses in the guide 156 of the guide in the fixed position 158. This movement causes the transfer instruments 150 to move radially inward as explained above, ensuring that the transfer instruments 150 are disengaged from the recesses in the guide 156, and are placed between the channels 152 of the cartridge holder 126 and the recesses 154 of the piston holder 138. This placement of the transfer instruments 150 causes the cartridge holder 126 and the piston holder 138 to move again as a unified component. Movement of these unified components in the proximal direction causes the cartridge 54 to also move in the proximal direction.

<td></td><td>Yes</td><td>I know</td><td>uses</td><td>a</td><td>safety syringe like</td><td>a</td>

<td>cartridge</td><td> 54</td><td>of the</td><td>injector</td><td colspan="2">automatic 50, mechanisms</td><td>of</td>

<td>security</td><td>of</td><td>the</td><td>j eringa</td><td>of</td><td>security can be activated</td><td>to the</td>

'íhé tí ia n'-fe ^ -' í ^

<td>end of</td><td>the</td><td colspan="4">drug delivery stage</td>

<td>operation</td><td>of</td><td>the</td><td>syringe.</td><td>In</td><td>consequence ·, ”the ·</td>

<td>placed</td><td>in</td><td>the</td><td>carrier</td><td>of the</td><td>cartridge 126 i</td>

of injector cartridge 54— automatic 50, will be safe for removal and disposal by the user. Optionally, the user can reattach the rigid needle shield 60 to the distal end of cartridge 54, such as the distal end of barrel 56, after the syringe has been used (i.e., drug delivery has been terminated ). In the position illustrated in Figures 10E and 15A-15B, the autosampler 50 is reset to its original configuration and is again ready to accept another cartridge 54, thereby constituting a reusable autosampler 50.

As discussed above, one or more sensors can be used for security or for other reasons. For example, a patient sensor 165 can be used at a distal end of the reusable autosampler 50 to ensure that it is in contact with the patient prior to injection of the needle. A cartridge sensor 160 can be similarly used to ensure that a cartridge 54 is correctly in position within the cartridge holder 126 prior to operation. Other sensors known in the art can be used for this or other purposes, and are contemplated and encompassed within the scope of the embodiments of the present invention. Similarly, other components can be used.

<img file="MX355019B_D0053.tif" />

improve the security and functionality of the TlTyetiLur — antcimérteiew

fifty. For example, a cartridge ejector assembly 182 can be used to removably secure and eject cartridge 54 during and after operation, respectively. An example of a cartridge ejector assembly 182 is shown in Figures 2 and 5.

Another embodiment of a cartridge ejector assembly 184, shown in Figures 16A-16B, may alternatively be provided to facilitate easy removal of cartridge 54 from housing 52. Although ejector assembly 184 may be of any appropriate design, In the illustrated embodiment, an ejector pin 186 is positioned to slide from a loaded position shown in Figure

16A to the ejection position shown in Figure 16B, as a result of movement of a switching switch 188 placed on the upper surface of housing 52.

When cartridge 54 (not shown) is loaded into housing 52, the switch switch

188 it can be manually moved to a position that places the ejector pin 186 below the level of a loaded cartridge 54, or cartridge 54 can be used to depress the ejector pin 186, so that the ejector pin 186 is placed underneath the loaded cartridge 54, that is, the position shown in Figure 16A. Ejector pin

186 of this modality f ^{; i} 1

INSTITUTO MSXJCANO DE LA IROPIEDAD at irflMlpt jr

<img file="MX355019B_D0054.tif" />

switching 188 through an articulacl'ári IDO 'that gÍ &amp; a.

about an axis 192, to switch the pin of the ejector 186 between the loaded position shown in Figure 16A and the ejection position shown in Figure 16B. It will be appreciated, however, that any appropriate design can be used. For example, a cartridge ejector assembly can be configured to automatically eject a cartridge 54 upon completion of drug delivery and retraction of cartridge 54 or needle 58 and cartridge 54.

As mentioned above, there are several modifications that can be made within the contemplation of the embodiments of the present invention. For example, alternate gear trains and drive arrangements can be provided. Referring to Figure 17, in an alternate embodiment, the longitudinal movement of a plunger carrier 194 can be provided by a gear train including a rack and pinion gear arrangement 196 and pinion 198. In other words, the elongated drive device in this embodiment includes rack 196, which couples to piston carrier 194. It will be appreciated that rotation of pinion gear 198 coupled to rack 196 causes rack 196 and the associated piston carrier 194, move between the proximal and distal positions within a housing 200.

plunger 194 can be combined movement of a transfer instrument holder

11.

INST-T

V r'- '

.......... i

The movement d'é'jjNÍps ^ is selectively portted by cartridge 202 by means of 204, illustrated, for example, in Figure 18. Transfer instruments 204 switch between pawls or recesses 206, 208 on rack 196 and cartridge holder 202, respectively, through channels 210 in cartridge holder 202.

In order to provide rotary motion to the pinion gear 212, 214, a motor 216, 218 can be positioned at an appropriate angle to provide direct rotation to the pinion gear 212, 214 as shown, for example, in Figures 19. and 20, respectively. Those skilled in the art will appreciate that the gear train may alternatively include additional gears that allow the engine to extend longitudinally within the autosampler, while still using a rack to impart longitudinal movement to the carrier. plunger (not illustrated).

The reusable automatic injectors described above use a standard syringe. However, the automatic injectors of the present invention, in accordance with at least one other embodiment, may use one of the permanent plunger 228,

21, instead of a standard one, as

For example, the

230 of the carrier include an elongated 228, of the proximal end of the cylinder with a characteristic after seal necessity allowing

I Iv! λ ..

üVjTjTOTC · 7 'Σ.- yX ítf ÍA Pí-.CriJíDAD V'Mseae as i'iqMSWa rod of —.da. ... The ... illustrates in Figures 11A the interconnection characteristic of the piston 226, shown in the elongated projection in the way that during the operation 222 of the interconnection 230 of the piston 220. This the cartridge thus includes, the use of various after the reusable automatic cartridge, the piston interconnect drive controls the piston seal 220 in the distal direction by the elongated rod 228, interconnect 230 will enter rod Figure j eringa until 15B. plunger

Figure 21, can of a rod would reside within cartridge 224, and that directly acting configuration removes the one rod from the plunger, cartridges 224. In such an embodiment, 224 inserts into the injector components of the mechanism would cause feature 230 to mate directly with Cartridge 224. Axial movement of the piston carrier 226 and would cause the feature at the proximal end of cylinder 222 of cartridge 224. After this step, the function of the components of the drive control mechanism and the reusable autosampler are as described above for the steps of: removing from the rigid protection of the

<img file="MX355019B_D0055.tif" />

needle, needle injection, drug delivery and retraction of the needle. In such embodiments, a final step can be performed after retraction of the needle to ensure that cartridge 224 is removed from elongated rod 228 and the interconnecting feature of plunger 230 and plunger carrier 226. Other similar configurations can be used to this function, while remaining within the scope and contemplation of the present invention.

The autosampler can also include a cover release safety mechanism that prevents the cartridge cover from opening during certain stages of operation. In accordance with at least one embodiment of the present invention, a cartridge cover release safety mechanism can be operated by the drive control mechanism as it progresses through the steps of: loading the syringe cartridge, removing rigid needle guard, needle injection, drug dose delivery, and retraction of the needle and / or cartridge. In other words, the cover release safety mechanism allows opening of the cartridge cover only when the needle is not exposed to the user, i.e. during initial cartridge loading, when the needle guard is in place. place and / or after drug delivery and retraction £ -:.: .. ·^χ

INST1- ,:. . .

optional or needle protection. The cover release mechanism prevents opening of the cartridge cover during other stages of operation, that is, when the needle is exposed for drug delivery. In this way, the cover release safety mechanism operates to inhibit inadvertent user exposure to the needle to reduce or eliminate accidental needle stick injury to the user, providing a highly desirable safety feature.

<td></td><td>In</td><td>modality</td><td>of Figures 22A-22E,</td><td>by</td>

<td>example,</td><td>the</td><td>mechanism</td><td>release security</td><td>the</td>

<td>cover</td><td>of the</td><td colspan="2">Cartridge 232 is configured to be operated by</td><td>the</td>

<td>function</td><td>of the</td><td>mechanism</td><td>drive control.</td><td>The</td>

release actuator 234 is configured to slide in the proximal direction to release the cartridge cover (not shown) from housing 236. Cartridge cover release safety mechanism 232 includes a locking bolt 238 that is adapted to move between an obstructed position, preventing movement of release actuator 234 in a proximal direction (as shown in Figures 22B -22D), and a retracted position allowing movement of the release actuator 234 in a proximal direction (as shown in Figures 22A and 22E).

Bolt movement

<img file="MX355019B_D0056.tif" />

the clogged and retracted positions, ____ is controlled at least partially by the rocker 240. Movement of the rocker 240 is controlled at least partially by the movement of the plunger carrier 242. In the illustrated views, and for simplicity, only the portion of the carrier Plunger 242 positioned between guides 244 and plunger interaction feature 243 are illustrated. In this embodiment, the plunger carrier includes a downwardly sloping flange 245. Rocker arm 240 includes a channel 246 that receives an aspect of the lower end of locking bolt 238 and a catch arm 248 that is positioned to engage flange 245 of plunger carrier 242.

In order to control the movement of the rocker

240, a guide bolt 250 and shaft 252, both of which are fixed protrusions of housing 236. Rocker arm 240 includes a pair of channels 254, 256 positioned to receive guide bolt 250 and shaft 252, respectively, for control the movement of the rocker 240 as it slides in a plane. Rocker arm 240 is adapted to move along a predetermined path as guide channel 254 moves over guide pin 250, movement of slide channel 256 relative to axis 252 allows rocker arm 240 to slide and rotate for angular changes of rocker arm 240 relative to shaft 252.

<img file="MX355019B_D0057.tif" />

fi:

As the guide bolt 250 is displaced from the center of the guide cover 244 during the operation of the cartridge cover release safety mechanism 232, the guide bolt 250 can be reclined in the recess of the guide bolt. guide 257 of guide channel 254. Deflection elements 258, 260, such as springs coupled to housing 236 (for simplicity, the specific sections of housing 236 to which the springs are attached are not illustrated), may be used to direct the positioning of the release release safety mechanism. cartridge cover 232, specifically rocker arm 240, during operation.

Figure 22A shows the locking bolt 238 of the cartridge cover release safety mechanism 232 in the initial retracted position, allowing the latch release to be manipulated (eg, axially slid) to open the cartridge cover to load the cartridge into the autosampler. In this position, the flange 245 of the plunger carrier 242 is not in contact with the corresponding catch arm 248 of the rocker arm 240 of the cartridge cover release safety mechanism 232.

As the syringe cartridge is loaded into the autosampler, and the autosampler is activated by the user, plunger carrier flange 245 242 moves

Say axially in the proximal direction p'á'fá ^ et

<img file="MX355019B_D0058.tif" />

cartridge for removal of the rigid protector of the needle / po-g eg emplo.

As the plunger holder 242 moves proximally, the flange 245 contacts the corresponding catch arm 248 of the rocker arm 240 of the cartridge cover release safety mechanism 232, thereby pulling the catch arm 248 from the rocker arm. 240 in the proximal direction (see Figure 22B). As the rocker arm 240 is pulled proximally, the guide channel 254 slides into the guide pin 250 and the slide channel

256 it slides and rotates along axis 252. Guide bolt 250 moves in a withdrawable manner into position within recesses of guide bolt 257, causing lock bolt 238 to move upward on it. 5 obstruction position, together with the safety release.

This prevents the latch release from moving to unlock and open the cartridge cover. The rocker

240 and the locking bolt 238 are retained in this position while the actuation mechanism moves the plunger bearing O 242 to perform the drug delivery steps, including insertion of the needle and dosing of the drug to the user, as outlined. shown in Figure 22C and Figure 22D, respectively.

As shown in Figure 22E, upon termination of drug dose delivery and, optionally, plunger carrier retraction 242 in the proximal direction again, comes into contact again.

V v, r- - ·

Ijfi:

the needle and / or deMifájCtu transfers' áXldlinurite

The piston holder 242 with the catch arm 248

<img file="MX355019B_D0059.tif" />

of the rocker arm 240 of the cartridge cover release safety mechanism 232, thereby pulling the catch arm 248 of the rocker arm 240 in the proximal direction. This movement, together with the deviation force of the deviation elements 258, 260, causes the guide pin 250 to move from the recesses of the guide pin 257 of the guide channel 254 of the rocker 240, and to slide along of guide channel 254 to a final position, where the angle of the rocker arm 240 pulls the locking bolt 238 out of the obstructed position with the release of the latch. At this time, the release actuator 234 can again be freely operated to open the cartridge cover (for example, to remove the used syringe cartridge). In this way, by locking the release actuator 234 and keeping the cartridge cover in a closed and secured position during the operation of the reusable autosampler, user exposure to the cartridge is typically avoided, until the cartridge has returned to a position safe (eg, retracted, protected, covered) for the user.

As previously indicated, the

<img file="MX355019B_D0060.tif" />

τ · ν, ..transfer can be dimensioned and formed eh '^JWt^Liad * -? 5 ¥ flTa s different, while keeping your — nopootoc · mavgrinsnfi functional. In at least one embodiment, the transfer instrument may be a cylinder that functions to connect the components of the drive control mechanism and facilitate movement of the components through various stages described above. Also as described above, certain components can be single components or multiple components that work together.

These components can be separate parts that work together, for ease of manufacturing, for example, or can be a single part that provides more than one function. The shapes and configurations described herein are also merely exemplary, and other similar shapes having the same functionality may be used, within the scope and contemplation of the present invention.

In a further embodiment of the present invention, a drive control mechanism for a reusable autosampler 50 includes a drive screw 114, a cartridge holder 126, a plunger holder 138, and two transfer instruments 150. The drive mechanism The drive control may further include, for each transfer instrument, a plunger carrier recess 154 in plunger carrier 138, a

<img file="MX355019B_D0061.tif" />

<img file="MX355019B_D0062.tif" />

*· ¿5 ¹ ί / '·]

Go Jr i

MEXICAN INSTITUTE channel 152 inside the cartridge holder “Φ ^^ τμ ^ below guide 156 in guide 158. These components are dimensioned and configured so that the control transfer instruments are retained within the drive control mechanism and The Guide. For example, the cartridge holder 126 may be a thin object that has a rectangular hole through it like a channel. The transfer instrument may reside within the channel, but would be prevented from moving laterally along the axial plane of the cartridge holder 126, because it is retained on all four sides. Transfer Instrument Dimensions 150

<td>they are such</td><td>than</td><td>the instrument</td><td colspan="2">transfer always</td><td>this</td>

<td>coupled</td><td>of</td><td colspan="2">removable way with two</td><td>components</td><td>of the</td>

<td>mechanism</td><td>of</td><td>control of</td><td>actuation</td><td colspan="2">104 so</td>

<td>simultaneous</td><td colspan="2">. For example in</td><td>some stages</td><td>of operation</td><td>, the</td>

Transfer instrument 150 is removably coupled to the recess in guide 156 of guide 158 and channel 152 of cartridge carrier 126. In other stages of operation, transfer instrument 150 is removably coupled to channel 152 cartridge holder 126 and plunger holder recess 154 plunger holder 138. The drive control mechanism operates by driving the transfer instrument between the plunger carrier recess 154 of the

Τ&gt; / τ Ό Τ] i ¿yy JL ikstitv.-cx5Z! ~ A: jo Uj ^ isYí 'D¿ LA iw: LLf.o NDUsWAL * -carrier 138, channel 152 inside cartridge holder 126 , and the recess of the guide 156 from the guide 158, so that a single engine 106 and the transmission assembly

110 acting on a drive screw 114, can control the function of the multiple components, as described above.

The reusable autosamplers of the present invention are capable of accommodating partially or completely filled cartridges 54, 224 of variable capacity, including 1 mL cartridges 54, 224. The reusable autosampler could be used with retractable or safety syringes, including prefilled syringes as well as with non-safety syringes. When used with non-safety syringes, the cartridge 54, 224 is fully withdrawn into the reusable autosampler housing 52, after injection, to protect the user from exposed needles 58. After the signal for complete injection, the user can recap the non-safety syringe, while remaining in the reusable autosampler 52 housing, without risk of needle stick injury 58, since the needle tip 58 is contained within housing 52. The reusable autosampler or cartridge cover 72 can then be opened and the used cartridge 54, 224 can be safely disposed of in a container for

<img file="MX355019B_D0063.tif" />

sharp objects. The reusable autosampler would therefore provide a safe injection for non-safety syringes, in addition to working with most retractable needle syringes.

The present invention also provides reusable auto-injectors that are ergonomic, easy to use and aesthetically similar to products currently used by self-administered patients. The automatic injectors of the present invention provide sufficient force at adequate speeds to simulate an injection by a nurse or physician, while providing freedom of use for self-administered patients. The reusable automatic injectors of the present invention are also configured to withstand frequent use, such as daily use, for an extended period of time. The power source that powers the reusable auto injectors may similarly be replaceable, rechargeable, or otherwise provide power to use the injectors for an extended period of time. The present invention therefore provides a reusable autosampler with integrated safety mechanisms, enabled by incorporating a retractable needle syringe into the reusable autosampler, in a convenient and user-friendly packaging for patients.

<img file="MX355019B_D0064.tif" />

One or more of the modalities &amp; vsiS / áe

<img file="MX355019B_D0065.tif" />

above can provide characterjt, j, qg patients.

For example, the novel automatic injectors of the present invention can utilize existing or additional components within the housing to limit the depth of needle insertion. In one such modality, the features located in the accommodation or the guide can be used for this purpose. In another embodiment, mechanical limits may be integrated into the drive control mechanism, cartridge holder, plunger holder, or drive screw, to limit the extent of displacement of the syringe needle in the patient. Similarly, as described above, one or more components can be used to automatically remove the needle shield from the needle of the syringe upon activation of the reusable auto-injector.

In another embodiment, a single autosampler in accordance with the invention can be adjusted to accommodate cartridges that include needles of various lengths. In this way, a single autosampler can be used, for example, for intramuscular injections and subcutaneous injections. When adjusting for various needle lengths, the autosampler may include a mechanical adjustment and / or an electrical adjustment, for example, by means of

<img file="MX355019B_D0066.tif" />

<img file="MX355019B_D0067.tif" />

the user interface. The depth of the needle can be adjusted based on the movement of the cartridge holder within the housing, that is, as the cartridge and the needle move to the position illustrated in Figures 13A and 13B.

In accordance with another aspect of the invention, the processor of some embodiments can be programmed to precisely control the dose of the administered medication. For example, when a cartridge includes a volume greater than that required for administration, the autosampler may be directed to distribute the unnecessary volume prior to placement in the target tissue. The user interface can be used to program the autosampler to distribute the unnecessary volume prior to administration, for example, as long as the patient sensor 165 is not depressed.

Accordingly, the autosampler can be configured to send a portion of the drug dosage to a reservoir or the environment, prior to injection of the needle and delivery of the drug dose to a user, in order to reduce or adjust the drug volume. The autosampler can then be placed against the target tissue, triggering the patient sensor 165, to allow delivery of the dose. In another mode, the autosampler can be programmed to insert the

<img file="MX355019B_D0068.tif" />

programmed volume of lia ^ ufPLe ^ iCcHs ¥ © ff7 and the cartridge in the HirocníAr, prnv.-i.inal · of the target tissue.

needle, administer the then move to retract the needle

In additional modes, the autosampler may include one or more controls. For example, the autosampler may include an electronic control that can be operated via the user interface. Alternately or additionally, the autosampler may include a manual override. For example, removal of the autosampler from target tissue, such that patient sensor 165 is no longer activated, may cause the plunger holder to stop progression and the cartridge holder to retract the needle into the housing.

In another embodiment, the present invention relates to the method of making automatic injectors.

The method includes the steps of mounting a drive control mechanism including an elongated drive device, such as a drive screw 114 or a rack 196, a cartridge holder 126, a plunger holder 138, and one or more instruments. control transfer 150. The drive control mechanism may further include one or more plunger carrier recesses 154 within the plunger carrier 138, channels 152 within the cartridge carrier 126, and guide recesses 156 of the guide 158. These components are dimensioned and configured in such a way that the irsiiu.-; -: ·: Λ

Uto. . · &lt;·,. The instruments of control 150 (eg discs) aoft— of the drive control mechanism and the guide.

The method further includes the step of attaching a guide and a drive housing.

join one or more support

The method to the control mechanism of the may further include the steps of: a power source, an engine, transmission mount 110, a control system

106, such as a microprocessor, wherein the transmission assembly 110 is brought into contact with the drive screw 114. A cartridge 54 or housing 72 housing 52 may also be attached relative

The method the side

In even with a includes automatic injector top.

Another embodiment, the present invention is the method of use for an automatic injector.

the carriages contained in a and activate the injector steps of: inserting a cartridge 54 into the housing 52 of the automatic autosampler to initiate one or more of: removal of a drug-to-needle injection protection 58 cartridge optionally, needle 60, of a needle 58 through needle 58 of the, optionally, a patient, supply to the patient, retraction of the patient in the carrier housing method 52, and cartridge 126.

use may include removal of

In addition, the step of sending a portion of the dosage to the reservoir or to the environment, before the drug is injected into the

<img file="MX355019B_D0069.tif" />

needle and the dose supply of £ armacbk; in&gt; huñ

<img file="MX355019B_D0070.tif" />

in order to reduce or adjust the volume from Ί to. _ dose of the drug. Similarly, optionally, the method of use may include the step of adjusting the range of axial translation of the drive mechanism (and therefore, the syringe cartridge), to accommodate different needle lengths and / or depths. injection. The method may further include the steps of opening a cartridge cover 72 to access an interior of the autosampler prior to inserting a cartridge 54 into the cartridge holder 126, and the step of closing the cartridge cover 72 after cartridge 54 has been loaded into cartridge carrier 126. The method may similarly include the step of opening cartridge 54 or housing cover 72 52 to access an interior of the autosampler after retraction of needle 58 to remove used cartridge 54. The user can optionally reattach needle shield 60 to cartridge 54 before removing cartridge 54 from cartridge holder 126. After the used cartridge 54 has been removed from the cartridge holder 126 of the autosampler, the autosampler is reset and is ready to accept another cartridge 54.

The modalities shown and detailed in this document describe only a few possible variations of this

1171?

invention; other similar variations are contemplated and incorporated — déilLfó '·^lae ^1,1 the * breadth of this description.

As will be readily appreciated by someone with ordinary experience, various parameters, shapes, and dimensions described above, modified, while remaining within the scope and scope of the present invention.

For example, the distance the cartridge holder 126 moves in the distal direction · can be adjusted to ensure that a predetermined depth of needle insertion 58 is met. In addition or alternately, other standard components, such as elements Stop to avoid displacement of the carrier, can be used to achieve this or similar functions. Other features can be similarly adjustable. For example, the autosampler can be configured to accept different gear ratios and drive or rack screw pitches, to provide desired injection rates, for a range of drug viscosities and patient requirements. The present invention provides drive control mechanisms, reusable automatic injectors, methods of manufacturing such automatic injectors, and their methods of use. As noted above, drive control mechanisms and reusable autosamplers can be used in several different configurations comprising one or more components.

Otrns — ιτηπιρηηρηίΡ.ς They can in a similar unified way, be single components, non-components or components with multiple purposes, as described in the modalities discussed above. Such novel automatic injectors can be used, for example, by patients who require to self-inject their medication on a regular or long-term basis. Accordingly, similar to the examples provided above, the novel reusable auto-injectors of the present invention can be configured, modified, and used to initiate drug delivery and activate needle retraction, in any of several configurations, while remaining within of the breadth and scope of the present invention. Thus, the present invention is intended to cover the modifications and variations of this invention, provided that they are within the scope of the appended claims and their equivalents.

Incorporating the syringe retraction or syringe with the integrated needle retraction into a reusable auto-injector allows patients to safely self-administer a pharmaceutical treatment in a user-friendly manner. Incorporating the Features and Designs of the Novel Safety Syringe ¿LA&gt; '* 1 OAD ¡N3¿JSTklÁL

<img file="MX355019B_D0071.tif" />

The reusable autosampler provides a true indicator of end of dose. Additionally, a standard syringe can be used and retracted into the body of the autosampler to provide safety for the needle and indicate that the dose is complete. Although the syringes described herein may have integrated safety features, the automatic injectors of the present invention can be used with conventional syringes that lack such features.

Incorporation of such syringes into a disposable or reusable autosampler extends the syringe's built-in safety mechanisms into an automated drug delivery device, which is highly desirable by patients. More specifically, automatic injectors employing safety syringes with integrated needle retraction, described herein, may utilize the pre-filled syringe retraction mechanism in place of, or in addition to, other retraction mechanisms of the autosampler, such as reverse drive mechanisms. Furthermore, such automatic injectors also address a significant unmet need for an automatic injector with a true end-of-dose indicator. Currently, visual, tactile or audible indicators are generally related to career end or some other mechanism

<img file="MX355019B_D0072.tif" />

<img file="MX355019B_D0073.tif" />

mechanical, and not with the end of the dose. The safety syringe with the integrated needle retraction retracts the needle into the syringe barrel, withdrawing it from the patient's skin once the dose is complete. Therefore, incorporating such safety syringes an autosampler incorporates this true end-of-dose indicator. The embodiments of the present invention provide drive mechanisms, autosampler configurations, and methods for manufacturing and using reusable autosamplers. Such novel devices can be used, for example, by patients who require to self-inject their medication on a regular or long-term basis.

It will be appreciated that the foregoing description provides examples of the described system and technique. However, it is contemplated that other implementations of the disclosure may differ in detail from the previous examples. All references to the description or examples thereof are intended to refer to the particular example being discussed at that point, and are not intended to imply any limitation on the scope of the description more generally. All the language of distinction and contempt with respect to certain characteristics is intended to indicate a lack of preference for those characteristics, but not to exclude them from the scope of the

<img file="MX355019B_D0074.tif" />

<img file="MX355019B_D0075.tif" />

description entirely, unless · dé '- ^^ etra is indicated. ---------— —....---—

The use of the terms one, one and the, the and at least one and similar references in the context of describing the invention (especially in the context of the following claims), should be interpreted as covering the singular and plural, to Unless otherwise indicated herein or clearly contradicted by context. The use of the term at least one followed by a list of one or more articles (for example, at least one of A and B) should be interpreted as meaning an article selected from the listed articles (A or B) or any combination of two or more of the listed items (A and B), unless the context otherwise indicates here or is clearly contradicted by the context.

The exposition of the ranges of values ​​herein is merely intended to serve as a shortcut to refer individually to each separate value that falls within the range, unless otherwise indicated herein, and each separate value is incorporated in the specification as if individually set forth herein. All of the methods described here can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted otherwise by the context.

Τ Α, Γ ~ Ϊ • X: v '¿00 ·: i' 00 &lt;-A

Consequently, this description incTüyé-tod50'Tas modifications and equivalents of the materra¹Ob'J'eW ..... ErA^,prre? srt^,a '' “· in the claims annexed here, permitted by applicable law. In addition, any combination of the elements 5 described above in all possible variations thereof, is encompassed by the description, unless otherwise indicated herein or clearly contradicted otherwise by the context.

Τ 'τ. 77'- ~ y

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X. -,,

<td></td><td>Uc *. /. r 7! i. JAü INDUSTRIAL Item List</td>

<td>TITLE:</td><td>DRIVE CONTROL MECHANISMS AND INJECTORS</td>

AUTOMATIC FOR INJECTABLE CARTRIDGES

FILE: AI.140.US (based on AI.140.USP AND AI.137.USP)

ITEM NUMBER DESCRIPTION auto injector cartridge housing cylinder needle needle guard plunger mount plunger seal plunger rod plunger head enlarged finger flange cartridge cover

<img file="MX355019B_D0076.tif" />

<img file="MX355019B_D0077.tif" />

window distal ratchet protrusion housing body ratchet protrusion secure selectively operable

I Ρ ·. ·:

<td> 88</td><td>\ ·, Ϊ́ \ ') ... -, ... boss</td>

<td> 90</td><td>recess</td>

<td> 92</td><td>insurance release</td>

<td> 96</td><td>user interface</td>

<td> 98</td><td>release actuator</td>

<td> 100</td><td>lights</td>

<td> 102</td><td>elongated frame</td>

<td> 104</td><td>drive control mechanism</td>

<td> 106</td><td>engine</td>

<td> 108</td><td>power source</td>

<td> 110</td><td>transmission mount</td>

<td> 112</td><td>gear train</td>

<td> 114</td><td>drive screw</td>

<td> 116</td><td>pinion gear</td>

<td> 118</td><td>compound gear</td>

<td> 120</td><td>drive gear</td>

<td> 122</td><td>primary gear surface</td>

<td> 124</td><td>secondary gear surface</td>

<td> 126</td><td>cartridge carrier</td>

<td> 128</td><td>elongated frame</td>

<td> 130</td><td>cartridge connection feature</td>

<td> 132</td><td>pair of rails (cartridge holder)</td>

<td> 134</td><td>internal channel</td>

<td> 136</td><td>pair of longitudinally extending rails (housing)</td>

<img file="MX355019B_D0078.tif" />

138

140

142 Plunger Carrier Interconnect Feature (Plunger Carrier) Internally Threaded Hole

144 ___ portion of plunger carrier

146 transfer instruments base

150

<td> 152</td><td>channel</td>

<td> 154, 156</td><td>discounts</td>

<td> 154</td><td>discount</td>

<td> 156</td><td>discount</td>

<td> 158</td><td>guides</td>

<td> 160</td><td>cartridge sensor</td>

162 exhaust features

<td> 164</td><td>flange</td>

<td> 165</td><td>patient sensor</td>

<td> 166</td><td>catch</td>

<td> 168</td><td>retainer deflection element</td>

<td> 170</td><td>outgoing</td>

<td> 172</td><td>arched segments</td>

<td> 174</td><td>channels extending longitudinally</td>

<td> 176</td><td>arms</td>

<td> 180</td><td>elongated ends</td>

<td> 182</td><td>cartridge ejector mount</td>

Λ

-Λ and

OR.

<td></td><td>Τ ~ ΐ · ρ I.</td>

<td> 184</td><td>cartridge ejector mount</td>

<td> 186</td><td>ejector pin</td>

<td> 188</td><td>switching switch</td>

<td> 190</td><td>joint</td>

<td> 192</td><td>axis</td>

<td> 194</td><td>plunger carrier</td>

<td> 196</td><td>zipper</td>

<td> 198</td><td>pinion</td>

<td> 200</td><td>accommodation</td>

<td> 202</td><td>cartridge carrier</td>

<td> 204</td><td>transfer instruments</td>

<td> 206, 208</td><td>rebates</td>

<td> 210</td><td>channels</td>

<td> 212</td><td>pinion gear</td>

<td> 214</td><td>pinion gear</td>

<td> 216</td><td>engine</td>

<td> 218</td><td>engine</td>

<td> 220</td><td>plunger seal</td>

<td> 222</td><td>cylinder</td>

<td> 224</td><td>cartridge</td>

<td> 226</td><td>plunger carrier</td>

<td> 228</td><td>elongated rod</td>

<td> 230</td><td>interconnect feature</td>

<td> 232</td><td>cartridge cover release safety mechanism</td>

actuator

<img file="MX355019B_D0079.tif" />

housing ........... ................ 'securing bolt piston bearing rocker piston interaction characteristic guides rim channel catch arm guide bolt axis guide channel sliding channel guide pin recesses deflection elements r τ .. / .....

X. jL '., / ..

FROM THE inDUSViCAL