Medical injector with coupled body portions

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SPANISH OFFICE OF

PATENTS AND TRADEMARKS

SPAIN lllllllllllllllllllllllllllllllllllllllllll © Publication number: 2 736 182 © Int. Cl .:

A61M 5/178

A61M 5/32

A61M 5/24

A61M 5/20

A61M 5/31

A61M 5/34

A61M 5/00

A61M 5/315 (2006.01) (2006.01) (2006.01) (2006.01) (2006.01) (2006.01) (2006.01) (2006.01)

TRANSLATION OF EUROPEAN PATENT

T3 @ Date of submission and number of the international application: 18.09.2009 PCT / US2009 / 057446 © Date and number of international publication:

(se) Date of submission and number of the European application: © Date and publication number of the European concession:

25.03.2010

18.09.2009

08.05.2019

WO10033782

E 09815254 (9)

EP 2337597 @ Title: Medical injector with attached body parts © Priority:

18.09.2008 US 192465 P © Date of publication and mention in BOPI of the patent translation:

12.26.2019 © Owner / s:

BECTON, DICKINSON AND COMPANY (100.0%)

Becton Drive

Franklin Lakes, NJ 07417-1880, US © Inventor / es:

JETER, RUANE, S .; CRONENBERG, RICHARD, A .; VEDRINE, LIONEL and

PATEL, ATUL @ Agent / Representative:

ELZABURU, SLP

ES 2 736 182 T3

Notice: Within nine months from the date of publication in the European Patent Bulletin, of the mention of granting the European patent, any person may object to the European Patent Office to the granted patent. The opposition must be in writing and be motivated; It will only be considered as formulated once payment of the opposition fee has been made (art. 99.1 of the

Convention on the Granting of European Patents).

ES 2 736 182 T3

DESCRIPTION

Medical injector with attached body parts

Field of the Invention

This invention relates to medical injectors and, more particularly, to medical injectors having plunger drive mechanisms.

Background of the invention

Medical injectors are well known in the prior art, including injectors having internal drive mechanisms to advance the plunger. The advance of the plunger can be used to carry out the automatic reconstitution of a medicament of two or more parts and to cause the automated injection. More specifically, the automation of the advance of the plunger can be used to cause the combination of a multi-part medicament (for example, wet / dry). In addition, or alternatively, the automated advance of the plunger can cause a needle to advance for the injection and / or the medication to pass through the needle during the injection. Such automatic action requires a firing mechanism. There are concerns about the activation of premature or failed firing.

WO 2004/098687 A1 describes a multipath actuator for a sterile syringe.

WO 2005/077441 A2 describes an electronically controlled portable injection device for injecting preset doses of liquid medications, according to the preamble of claim 1.

US 2005/0197650 A1 describes an administration apparatus for medical use, comprising a compression and expansion mechanism for a piston rod assembly.

WO 99/59663 describes a modular drug delivery system for use by cardiothoracic surgeons and interventional cardiologists for the administration of molecular and cellular therapies that target genes, molecules and peptides.

Summary of the invention

The subject matter of this invention is defined in independent claim 1.

This document provides a medical injector that includes first and second body parts, each of which has a longitudinal axis and is configured to engage in a coupling. The first and second body parts are complementaryly formed so that they can move around the coupling. The medical injector also includes an axially movable plunger; request element for advancing the plunger a predetermined distance; and, a releasable retainer for releasably retaining the plunger in a first state against the force of the solicitation element. In an initial state, the axes of the first and second body parts are not aligned and the plunger is in the first state. In a coupled state, the axes of the first and second body parts are axially aligned, and the releasable retainer releases the plunger, which allows the solicitation element to advance the plunger a predetermined distance. Said releasable retainer comprises a movable cam member that includes a protruding stop member formed to engage by interference with a shoulder of the plunger so as to releasably retain said plunger in a first state against the force of said solicitation means. Advantageously, the present invention provides a medical injector having an automatic plunger drive that trips when the pen injector is assembled, thus minimizing premature or failed activations.

These and other features of the present invention will be better understood by studying the following detailed description and the accompanying drawings.

Brief description of the drawings

Figures 1 and 2 show a medical injector formed according to the object in the pre-assembled and assembled states, respectively;

Figures 3 and 4 are cross-sectional views of a medical injector formed according to the present invention;

Figure 5 is a schematic of a releasable retainer according to the present invention;

Figure 6 is a cross-sectional view of a medical injector formed according to the present invention having a reservoir configured for reconstitution;

Figures 7 and 8 show an arrangement for achieving relative movement of components;

Figure 9 is an exploded view of components usable with the present invention;

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Figure 10 is a cross-sectional view taken along line 10-10 of Figure 9;

Figure 11 is a perspective view of a dose button usable with the present invention;

Figure 12 is an exploded view of the present invention;

Figures 13-16 show the operation of a medical injector formed according to the present invention; Y

Figures 17-20 show cover configurations that can be used with the present invention.

Detailed description of the invention

With reference to the figures, a medical injector is shown and is generally designated by reference number 10. The medical injector 10 may be of various types, but is preferably of the pen injector type. Medical injector 10 can be used to administer various injectable liquids, particularly medications.

With reference to FIG. 1, the medical injector 10 includes first and second body parts 12, 14 that are connected by movement with respect to the coupling 16. Preferably, the coupling 16 is an articulated connection. The first and second body parts 12, 14 are formed in a complementary manner to be assembled with one another with sufficient movement, for example rotation, around the coupling 16. As shown in Figure 1, the longitudinal axes L1, L2 of the first and second body parts 12, 14 are not axially aligned (not collinearly) in an initial state of the medical injector 10. The state is shown in Figure 2 assembly of the medical injector 10 where the longitudinal axes L1, L2 are axially aligned.

The first and second body parts 12, 14 are preferably formed of rigid material and in different extensions accommodate different parts of the medical injector 10. Preferably, to facilitate assembly as shown in Figure 3, a reduced diameter part 18 is formed in one of the first and second body parts 12, 14 with a corresponding telescopic part 20 which is formed in the other of the first and second body parts 12, 14. In this manner, the first and second body parts 12, 14 can be assembled with the telescopic part 20 that is disposed on the reduced diameter part 18. In addition, cooperating locking elements 22, such as cooperating retainers and grooves, can be provided. , gear teeth and / or other pressure blocking features to lock together the first and second body parts 12, 14 once assembled.

As shown in the figures, particularly in figures 7 and 8, the coupling 16 may be a pin hinge where brackets 24 are provided in the first and second body parts 12, 14 that are together to rotate around a pin center 26. As those skilled in the art will appreciate, a live hinge can also be used for coupling 16. The coupling 16 is positioned and formed to allow adequate movement, for example rotation, around it by allowing the first and second body parts 12, 14 to come together and form the medical injector 10.

The medical injector 10 includes an axially movable piston 28. The piston 28 may be formed as a single piece or by modular components. Modular components can be fixed together or adjacently, but not connected, in order to move together. The piston 28 is initially located in the second body part 14. A solicitation element 30 is also arranged, configured and positioned to advance the piston 28 a predetermined distance. Preferably, the solicitation element 30 is a compression or helical spring, but other solicitation elements can also be used. Preferably, the solicitation element 30 is positioned in the second body part 14.

A releasable retainer 32 is provided configured and positioned to releasably retain the plunger 28 in a first initial state against the force of the solicitation element 30. The releasable retainer 32 is configured such that, by assembling the first body parts and second 12, 14, the releasable retainer 32 releases the piston 28, thereby allowing the solicitation element 30 to advance the piston 28 the predetermined distance.

It is preferred that the plunger 28 be advanced in a distal direction. As used herein, distal refers to a direction towards a patient during use, while proximal refers to a direction away from a patient during use.

The releasable retainer 32 is a movable cam member 34, as shown in Figures 3-5. As shown in Figures 3 and 4, when assembling the first and second body parts 12 14, a cam arm 36 moves, for example by interfering the coupling with a part or component of the first body part 12, causing thus the displacement of the cam member 34. The cam member 34 includes a protruding stop member 38 formed to engage by interference with a shoulder 40 of the plunger 28, causing it to retain in a first initial state, before use. With the displacement of the cam member 34, the cam member 34 releases the shoulder 40, thus allowing the solicitation element 30 to distally actuate the piston 28. It is preferred that the cam member 34 is pivotally connected to the second body part 14, so that it is rotatable relative to it. The displacement of cam member 34 can be achieved by

EN 2 736 182 T3 mutual coupling of the ramp surface 42 of the cam arm 36 acting against the coupling surface 44 of the cam member 34 under the movement of the cam arm 36, resulting in a sufficient rotation of the cam member 34 to clear the stop member 38 with respect to shoulder 40.

The medical injector 10 includes a reservoir 46 disposed in the first body part 12 formed to accommodate the medication or other substance 48 for injection in a patient. As shown in Figure 3, the reservoir 46 may be a single chamber disposed in a cylinder 50 sealed at a proximal end by a septum 52 and sealed at a distal end by a plug 54 that is formed to be slidable through the cylinder 50 in order to push the substance 48 from there, as is known in the art. The medical injector 10 also includes a needle mounting surface 56 having features 58 formed thereon to mount a needle 60 thereto. Needle 60 may include a hub 62 having mounting characteristics 64 disposed therein for cooperative engagement with features 58 during assembly of needle 60 on needle mounting surface 56. The features 58 and the mounting features 64 can be of any known cooperating element that allows a mechanical connection between them, such as threads or bayonet lock, and / or a mutual frictional coupling, such as a Luer mount. The needle mounting surface 56 can be formed in the first body part 12 or in a component thereof.

Needle 60 also includes a needle cannula 61 having a distal end 63, formed for insertion into a patient, and a proximal end 65.

The reservoir 46 can be configured to accommodate multiple components that can be mixed for reconstitution. For example, as shown in Figure 6, the reservoir can accommodate first and second mixable components 66, 68. The plug 54 may be associated with the tank 46 such that the distal advance of the plug 54 along a Default distance will cause mixing of the first and second mixable components 66, 68. Any known arrangement can be used to allow such mixing. By way of non-limiting example, the first and second mixable components 66, 68 may be separated by a secondary plug 70. The secondary plug 70 divides the tank 46 into first and second chambers 72, 74, respectively, accommodating the mixable components first and second 66, 68. Sept 52 seals the distal end of the first chamber 72, while the cap 54 is placed to seal the proximal end of the second chamber 74. Preferably, if a dry component is used as one of the mixable components, the component can be mixed in Dry is located in the first chamber 72.

One or more bypass channels 76 are formed in the wall of the reservoir 46. In an initial state, as shown in Figure 6, the secondary plug 70 is located at least partially proximal with respect to the bypass channels 76 to define a joint between the first and second chambers 72, 74 and to define a joint between the second chamber 74 and the bypass channels 76. With distal advance of the plug 54, and with the second mixable component 68, which is wet and generally incompressible, the movement force of the plug 54 is transmitted to the secondary plug 70 through the second mixable component 68. With sufficient distal movement of the secondary plug 70, the second chamber 74 communicates with the bypass channels 76, thus allowing the second mixable component 68 to be introduced into the first chamber 72 with an additional distal movement of the plug 54. With a Sufficient distal advance of the cap 54, the second chamber 74 is crushed with none or substantially none of the second mixable component 68 remaining therein. In addition, the secondary plug 70 is located to define a joint between the first chamber 72 and the bypass channels 76. The first and second mixable components 66, 68 are mixed within the first chamber 72, such as by agitation of the medical injector 10 , to produce the injectable substance 48, ready for injection.

The cylinder 50 of the reservoir 46 may be the cylinder of a separate medicament cartridge, as shown in the figures, or a part of the medical injector 10, particularly the first body part 12.

As those skilled in the art will recognize, other arrangements can be used to allow reconstitution. In addition, systems with more than two parts can be used, such as three-part systems, etc. Active medical ingredients may be included in one or both of the first and second mixing components 66, 68. The first mixable component 66 may be dry (for example, a powder or granular substance) and / or a liquid (for example, fluid ( porridge or liquid)). As mentioned above, the second mixable component 70 is preferably only a wet fluid component, such as a liquid or a porridge.

The distal advance of the piston 28 under the force of the solicitation element 30 can be used to achieve one or more objectives. The piston 28 is configured to act against the plug 54 and cause its displacement. With the tank 46 configured for reconstitution, the self-reconstitution of the contents of the tank 46 can be achieved. In addition, or alternatively, the medical injector 10 may be configured to be an auto-injector, where the needle 60 is initially housed within the first body part 12 and pushed out by the force of the solicitation element 30 to pierce the skin of a patient, for example, with the forward movement of the reservoir 46, as is known in the art. In addition, or alternatively, the distal advance of the plunger 28 may cause the administration of the contents of the reservoir 46 through the injected needle.

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Depending on the desired effect, the medical injector 10 can be configured to cause the piston 28 to move a predetermined distance. A physical stop, such as the mutual coupling between the shoulder 40 and a proximal end 78 of the reservoir 46 (for example, the proximal end of the cylinder 50), can be used to limit the distal advance of the piston 28. In certain circumstances, the piston 28 can advance distally without the needle 60 being mounted on the medical injector 10. Therefore, the tank 46 is not ventilated during such an action. With the needle 60 subsequently mounted in the tank 46, any residual gas trapped in the tank 46 is purged through the needle 60. It may be preferred not to provide a physical stop to the distal advance of the piston 28. Thus, the contents of the tank 46 can be compressed to the fullest under the force of the solicitation element 30. With the subsequent assembly of the needle 60 in the medical injector 10, the reservoir 46 is thus vented, which allows for greater distal advance of the plunger 28. This secondary distal advance may assist in priming the needle 60 for use.

Figure 6 shows the medical injector 10 in a state prior to use. As shown herein, the reservoir 46 can be a medicament cartridge that can be separated from the first body part 12. One or more cartridge retention hooks 80 can be provided to act against the cylinder 50 by holding it in the first body part 12. It is preferable that the cartridge retaining hooks 80 are elastic to allow outward deflection when loading the reservoir 46 in the first body part 12.

It is preferred to provide a cartridge retainer 82 that includes a sleeve 84 within which the reservoir 46 is disposed. In addition, it is preferred that the needle mounting surface 56 and the cartridge retainer hooks 80 be formed in the element of cartridge retention 82. The cartridge retaining element 82 can be retained in the first body part 12 by any known fixing arrangement, such as a mechanical connection, for example, pressure coupling or friction connections, and / or chemical or adhesive connections, such as fusion, welding or gluing.

The movement of one or more of the components with respect to the first and / or second body parts 12, 14 may be desired. To obtain such relative movement, with reference to Figures 7 and 8, a pinion 86 can be mounted on one of the first and second body parts 12, 14 with a corresponding rack 88 mounted on the component intended for relative movement. As shown in the figures, the cartridge retention element 82 may be configured for movement with respect to the first body part 12. For this purpose, the cartridge retention element 82 may be nested within the first body part 12 with zipper 88 located in it. The pinion 86 and the rack 88 are formed with teeth 87, 89 formed for a cooperating engagement coupling. With the movement around the coupling 16, the pinion 86 rotates and causes a linear translation of the rack 88, which causes the cartridge retaining element 82 to move with respect to the first body part 12. This linear translation allows various axial adjustments of reservoir 46, or other components. The needle mounting surface 56 can be formed in the cartridge retaining element 82 and initially made to hide in the first body part 12 (Figure 1) with a subsequent distal advance by translating the cartridge retaining element 82 causing the needle mounting surface 56 to be exposed (figure 2). In this way, a control can be established on the correct synchronization of the needle mounting surface 56 during the preparation sequence of the medical injector 10. In particular, it may be desired to expose the needle mounting surface 56 only after reconstitution, if reconstitution is used.

The medical injector 10 may be a fixed dose injector configured to administer single or multiple fixed doses. In addition, medical injector 10 can be configured to allow dose adjustment for single or multiple doses. In a preferred embodiment, the medical injector 10 is a single variable dose self-reconstitution injector.

As those skilled in the art will appreciate, various configurations can be used to allow dose adjustment. By way of non-limiting example, and with reference to Figures 9 and 10, a button shank 90 may be provided with a plurality of support surfaces 92 axially and radially spaced.

The bearing surfaces 92 are axially aligned with a coupling surface 94 formed in the piston 28, such that, with a sufficient distal displacement of the button rod 90, at least one of the bearing surfaces 92 will be made to be engage with the coupling surface 94 and transmit a force of movement to the piston 28. In this way, the distal displacement of the button rod 90 can be transmitted to the piston 28. In addition, the length of the stroke corresponding to the movement of the piston 28 can be adjusted depending on the bearing surface 92 that is in engagement with the coupling surface 94. The greater the initial distance of the bearing surfaces 92 from the surface of coupling 94, the lower the corresponding dose to be administered. Regardless of the amount of dose selected, it is preferred that the button rod 90 has a fixed stroke length for distal displacement during the administration of an injection. The other bearing surfaces 92 have a greater movement lost with the distal movement of the button shank 90 and, therefore, a shorter coupling distance with the coupling surface 94. The extent of the movement of the piston 28 dictates the extent of movement of the cap 54 and, therefore, dictates the amount of the injectable solution 48 to be ejected from the reservoir 46 in an injected dose.

The dose is selected by turning a dose button 96 that is fixed to the button rod 90 to rotate with it. The dose button 96 and the button rod 90 can be connected in any known manner, including by cooperating mechanical elements. To prevent the dose knob 96 from turning inadvertently before the

ES 2 736 182 T3 suitable preparation of the medical injector 10, such as before mixing the mixable components 66, 68, the assembly of the first and second body parts 12, 14, and so on, the button rod 90 can be coupled with the plunger 28 to prevent relative rotation between them with the plunger 28 which is non-rotatably coupled with the second body part 14. With reference to FIG. 9, the plunger 28 may have one or more lobes 98 formed to nest in the corresponding channels 100 formed in the second body part 14. The plunger 28 may slide along the channels 100 without turning with respect to to them. In turn, the plunger 28 may have one or more internal grooves 102 in which the corresponding keys 104 that protrude from the plunger 28 are initially nested. With the distal advance of the piston 28, the piston 28 can be disengaged from the button shank 90 to allow relative rotation between them.

Furthermore, with reference to Figures 9 and 10, a slot 106 can be formed in the button shank 90 corresponding to a rib 108 formed in the plunger 28. In an initial state, the rib 108 is nested within the groove 106 for avoid relative rotation between piston 28 and button rod 90. Once the distal advance of the plunger 28 is completed, such as with a complete reconstitution, the plunger 28 can be advanced so that the rib 108 is removed from the groove 106 and the key 104 is removed from the internal groove 102. The button shank 90 can then turn freely to adjust a dose. Alternatively, the rib 108 may still be partially nested in the groove 106 even after the distal advance of the plunger 28, such as in a constituted dessert state. With this configuration, the button rod 90 can be displaced proximally so that the rib 108 is removed from the slot 106, thus allowing subsequent dose adjustment. The dose is administered causing a distal advance of button 90 once the dose has been adjusted correctly.

It is noted that the coupling surface 94 may be located at a proximal end 110 of the rib 108.

It is preferred that the dose button 96 be releasably retained in the positions corresponding to the various dose settings. Thus, it is preferred that once a dose has been adjusted, there is no rotation of the dose knob 96 during distal displacement thereof, thus preventing improper support surfaces 92 from engaging with the coupling surface 94 Such an arrangement is described in US Pat. No. 6,793,646. As shown in US Pat. No. 6,793,646, and with reference to Figures 11 and 12, one or more tabs 110 can be formed on the dose knob 96 that can be selectively coupled with one or more positioning channels 112 formed in the second body part 14. The positioning channels 112 may be circumferentially spaced and positioned to represent dose adjustments corresponding to the support surfaces 92. The tabs 110 are nested in the positioning channels 112 at given radial positions of the dose button 96 corresponding to different dose sizes. With the rotation of the dose button 96, the tabs 110 are made to move away from the dose positioning channels 112. The positioning channels 112 maintain the radial position of the dose button 96.

In addition, it is preferred that the dose knob 96 has limited axial movement to allow a fixed stroke length of distal advance for dose administration. The second body part 14 may be provided with a reduced diameter opening 116 sized and positioned to engage by interference with the button shank 90 after a predetermined measure of proximal movement. The stroke of an injection is defined by the extension of the proximal movement of the button rod 90.

For use, the medical injector 10 is initially presented in the state shown in Figure 1, where the first and second body parts 12, 14 are separated. To prepare its use, the first and second body parts 12, 14 are they move around the coupling 16 to reach the assembled state shown in Figure 2. It is preferable that a needle is not mounted on the medical injector 10 before assembly. With the assembly, the piston 28 is advanced distally under the force of the movement by means of the solicitation element 30. Reconstitution and / or other effects are achieved by this automated movement. Next, the needle 60 is mounted on the medical injector 10 as shown in Figure 13. The needle 60 may be provided with a cap or shield 60A. Any gas trapped in the tank 46 is purged through the needle 60 and the needle 60 can be primed for use.

With reference to Figures 14 and 15, a dose can be selected by proximally extracting the dose button 96. The proximal extraction of the dose button 96 is limited, as described above. Once removed, dose button 96 can be turned to a desired setting. Marks 116 may be provided to represent doses. Marks 116 may include numerical representations and a pointer or other indicator. With reference to Figure 16, the needle 60 is made to pierce the skin of a patient and then the dose button 96 is pressed to make the button rod 90 advance distally. The coupling of the selected surfaces between the bearing surfaces 92 and the coupling surface 94 causes the plunger 28 to actuate the plug 54 to administer an injection.

With the pre-use assembly of the medical injector 10, a cover 118 can be provided to at least partially cover the first and second body parts 12, 14, in particular around the coupling 16 as shown in Figures 17-20.

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The lid 118 may be formed of a rigid material with a general cup shape. A loading opening 120 can be formed in the lid 118 placed on the first body part 12 to allow the reservoir 46 to pass through it and be loaded into the first body part 12. In this way, a medical injector 10 it can be stored without the reservoir 46 being located therein. The tank 46 can be loaded into the medical injector 5 10 without having to remove the lid 118 therefrom. In addition, the lid 118 may be formed to accommodate one or more of the needles 60 inside. To maintain a clean and sterile environment within the lid 118, a sterility barrier 122, such as a removable film, is preferably provided to cover the loading opening 120. The lid 118 can also be configured to form a tight seal around the medical injector 10. A complementary compartment 124 can be provided with the lid 118 to completely enclose the medical injector 10.

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