US10071196B2

US10071196B2 - Method for selectively powering a battery-operated drug-delivery device and device therefor

Info

Publication number: US10071196B2
Application number: US13/472,112
Authority: US
Inventors: Oz Cabiri
Original assignee: West Pharma Services IL Ltd
Current assignee: West Pharma Services IL Ltd
Priority date: 2012-05-15
Filing date: 2012-05-15
Publication date: 2018-09-11
Also published as: EP2852421A1; WO2013173092A1; US20130310753A1; EP2852421B1; CN104321092A; CN104321092B

Abstract

A method for selectively powering a battery-operated drug-delivery device, the device having a battery and a battery circuit, the method comprising: providing a battery isolator in a first position whereat it interrupts a battery circuit, whereby no power is provided to the device; and activating a fastening mechanism configured for fastening the device to a user, the activating causing the battery circuit to be uninterrupted by the isolator, such that power is provided to the device. Additionally, there is provided a selectively powered battery-operated drug-delivery device, comprising: a selectively-removable isolator disposed in a first position whereat it interrupts a battery circuit; the isolator movable to a second position whereat the battery circuit is uninterrupted by the isolator; and a mechanism for fastening the device to a user, activation of the fastening mechanism moving the isolator from the first position to the second position.

Description

BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to a selectively powered battery-operated device and, more particularly, but not exclusively, to a selectively powered battery-operated drug-delivery device, the device having a battery and a battery circuit.

It may be desirable to interrupt a battery circuit by placing, for example, a plastic tab along the battery circuit, for example, between a battery and en electrical contact or between a pair of batteries in series, thereby preventing the completion of an electrical circuit.

For example, U.S. Pat. No. 8,086,306 discloses a defibrillator device which has a removable tab disposed “between a battery terminal and an electrical contact inside the battery compartment.” The tab serves as a battery isolator, for preventing draining of the battery when the device is not in use. When it is desired to operate the device, a “user pulls the tab to remove it from the battery compartment. This completes the circuit” so that the device may be used.

U.S. Pat. No. 6,336,729 teaches an emergency light device which is powered by a battery which forms part of a battery circuit. The battery circuit also includes a pair of contacts which are biased toward each other and between which a battery insulating member is disposed, thereby interrupting the battery circuit. The device also includes a cover to which is attached an activation button connected to the insulating member. When the cover is opened, the insulating member is removed from the battery circuit, thereby causing the device to be activated, whereby the light goes on.

Additional background art includes U.S. Pat. Nos. 5,645,955 and 5,795,675.

SUMMARY OF THE INVENTION

The present invention in some embodiments relates to apparatus for selectively powering a battery-operated drug-delivery device and a selectively powered battery-operated drug-delivery device, the device having a battery and a battery circuit.

The device may include features, for example, as shown in Applicant's U.S. Patent Applications Publication Nos. 2011/0178472, 2010/0168683, and 2011/0066131; U.S. Pat. No. 7,967,795; and WO Patent No. 2011/090955.

According to an aspect of some embodiments of the present invention there is provided a method for selectively powering a battery-operated drug-delivery device, the device having a battery and a battery circuit, the method comprising: providing a battery isolator disposed in a first position whereat the isolator contacts a battery terminal so as to interrupt the battery circuit, such that no power is provided to the device; and activating a fastening mechanism of the device, the fastening mechanism configured for fastening the device to the skin of a user, the activating causing movement of the battery isolator to a second position whereat the battery circuit is uninterrupted by the isolator, such that power is provided to the device.

According to some embodiments of the invention the fastening mechanism includes an adhesive surface; and the activating includes removing a protective cover from the adhesive surface.

According to some embodiments of the invention the providing includes providing a pre-attached isolator to the protective cover.

According to some embodiments of the invention the providing includes providing the isolator as an extension of the protective cover.

According to some embodiments of the invention the protective cover includes a tab configured to facilitate removal of the protective cover from the adhesive surface; and the activating includes pulling the tab so as to remove the protective cover from the adhesive surface.

According to some embodiments of the invention the protective cover includes a single portion configured to cover the adhesive surface; and the activating includes removing the protective cover so as to expose the entire adhesive surface.

According to some embodiments of the invention the protective cover includes at least two portions, each portion configured to cover a corresponding portion of the adhesive surface; the removing including removing a particular one of the at least two portions.

According to some embodiments of the invention the isolator is attached to a particular one of the at least two portions.

According to some embodiments of the invention the device includes a battery chamber and wherein, when the isolator is in the first position, the isolator is at least partially disposed in the battery chamber adjacent at least one of the at least one battery contact.

According to some embodiments of the invention, when the isolator is in the first position, the isolator is at least partially disposed between the at least one battery contact and a corresponding battery terminal of the battery located in the battery chamber; and

the activating includes removing the isolator from between the at least one battery contact and the corresponding battery terminal of the battery located in the battery chamber.

According to some embodiments of the invention the battery circuit includes at least first and second batteries, the providing including providing the isolator in the first position whereat the isolator prevents a battery contact of the first battery from electrically contacting a battery contact of the second battery; the activating causing the isolator to be moved to the second position whereat the battery contact of the first battery electrically contacts the battery contact of the second battery.

According to some embodiments of the invention the device includes a battery chamber and wherein, when the isolator is in the first position, the isolator is at least partially disposed in the battery chamber adjacent at least one of the battery contact of the first battery and the battery contact of the second battery.

According to some embodiments of the invention, when the isolator is in the first position, the isolator is at least partially disposed in the battery chamber between the battery contact of the first battery and the battery contact of the second battery; the activating including removing the isolator from between the battery contact of the first battery and the battery contact of the second battery.

According to some embodiments of the invention the method further comprises: providing an additional battery isolator disposed in a first position whereat the additional isolator contacts a battery terminal so as to interrupt the battery circuit, such that no power is provided to the device; and activating an obstruction member of the device, the obstruction member configured for preventing a needle from projecting out of the device, the activating the obstruction member causing movement of the additional battery isolator to a second position whereat the battery circuit is uninterrupted by the additional isolator, such that power is provided to the device when the fastening mechanism is activated.

According to an aspect of some embodiments of the present invention there is provided a selectively powered battery-operated drug-delivery device, the device having a battery and a battery circuit, the device comprising: a selectively-removable isolator, the isolator disposed in a first position whereat the isolator contacts a battery terminal so as to interrupt the battery circuit, such that no power is provided to the device; the isolator configured to be movable to a second position whereat the battery circuit is uninterrupted by the isolator, such that power is provided to the device; and a fastening mechanism configured for fastening the device to the skin of a user, the fastening mechanism including a selectively removable portion, the battery isolator extending from the removable portion.

According to some embodiments of the invention the device comprises a housing, the housing including an opening through which the isolator extends when in the first position.

According to some embodiments of the invention the opening comprises a slot.

According to some embodiments of the invention the isolator extends from outside the housing, through the opening.

According to some embodiments of the invention the device further comprises a protective cover on the fastening mechanism, wherein the isolator extends from the protective cover, through the opening.

According to some embodiments of the invention the fastening mechanism includes an adhesive surface.

According to some embodiments of the invention the isolator is pre-attached to the protective cover.

According to some embodiments of the invention the isolator is an extension of the protective cover.

According to some embodiments of the invention the protective cover includes a tab configured to facilitate removal of the protective cover from the fastening mechanism.

According to some embodiments of the invention the protective cover includes a single portion configured to cover the entire the fastening mechanism.

According to some embodiments of the invention the protective cover includes at least two portions, each portion configured to cover a corresponding portion of the fastening mechanism.

According to some embodiments of the invention each of the at least two cover portions includes a tab configured to facilitate removal of the cover portion from the fastening mechanism.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a perspective view of an automatic drug injection device having a battery isolator, in accordance with an exemplary embodiment of the present invention;

FIG. 2 is a perspective view of an exemplary embodiment of the drug injection device shown in FIG. 1, wherein the battery chamber cover has been removed;

FIG. 3 is a perspective view of an exemplary embodiment of the drug injection device shown in FIG. 1, wherein the adhesive surface cover has been separated from the adhesive surface;

FIG. 4 is a schematic drawing of an exemplary embodiment of a battery circuit employing a battery isolator, in accordance with the present invention; and

FIG. 5 is a flowchart illustrating an exemplary embodiment of a method for selectively powering a battery-operated drug-delivery device, in accordance with the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

In accordance with embodiments of the invention, there is provided a device including a fastening mechanism for fastening the device to the skin of a user configured such that activating the fastening mechanism results in movement of a battery isolator from a first position whereat the isolator interrupts a battery circuit, such that no power is provided to the device, to a second position whereat the battery circuit is uninterrupted by the isolator, such that power is provided to the device. This coupling of the battery isolator to the fastening mechanism has the potential advantage of providing the device with an easy to operate method of automatically powering up the device, which signifies imminent usage thereof, with little or no complicated preparation or activation protocols.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways, as discussed herein.

Referring now to the drawings, FIG. 1 illustrates an automatic drug injection device 10 having a battery isolator in accordance with the present invention. The automatic drug injection device 10 includes a housing 12 which is sized and shaped for housing a container such as a preloaded cartridge or a vial (not shown) of a drug to be injected by a user. Such a preloaded drug cartridge or vial may contain a volume of drug in the range of, for example, 0.7 ml-5 ml. Optionally, a drug cartridge or vial may contain any other volume of drug such as, for example, 10 ml.

As used herein, the term “drug” means any type of medicament, serum, or pharmaceutical composition which it may be desired to inject into a user. Additionally, as used herein, the term “delivery” means the transfer or conveyance of a drug from a device, by needle, into a user.

With additional reference to FIG. 2, there is shown a drug injection device similar to that shown in FIG. 1, wherein a battery chamber cover 22 has been removed. Optionally, the device 10 has no battery chamber cover. As seen in FIG. 2, inside housing 12 there is provided a battery chamber 14, the chamber 14 configured for containing a battery 16 for powering the device. Battery 16 forms part of a battery circuit 17 (FIG. 4), as known in the art, and includes, in addition to battery 16,

battery contact pads

18 and 20.

Optionally, instead of device 10 being powered by a single battery having a positive contact and a negative contact at opposite ends thereof, device 10 may be powered by a battery having a pair of contacts at one end thereof such as, for example, an Energizer 9V battery, model number EN22. Optionally, instead of a single battery, device 10 may include a battery circuit containing more than one battery in series or in parallel. Optionally, device 10 may be powered by at least one battery which is welded or otherwise fastened to a battery contact so as to be in electrical contact therewith.

Battery chamber

14 is provided with an optionally removable cover 22 (FIG. 1) which may be used to close the chamber 14. Cover 22 may be attached to housing 12 by any known means (not shown) such as, for example, screws, snap-in flanges, etc. Cover 22 is removable so as to allow the insertion and removal of battery 16 and closure of battery chamber 14.

Device

10 may be provided with a compartment 24 for housing a drug vial, as known in the art, the drug to be injected by a user via a needle 26, as will be discussed herein, in more detail. Compartment 24 may be provided with a cover 25 which, optionally, must be closed in order for the device to be operational, as discussed further herein.

Needle

26 is disposed within device 10 and may, for example, be flush with top side 42 thereof, and device 10 is provided with an actuation button 28 which, upon pressing thereof, causes needle 26 to be projected out of opening 38 in device 10 in the direction of arrow 30. Pressing of actuation button 28 also causes the drug in compartment 24 to be pumped out of device 10, via needle 26. The needle projection mechanism and pumping mechanism used may be any such mechanisms known in the art and will, therefore, not be described herein. It will, however, be appreciated by persons skilled in the art that either or both of projection of needle 26 out of device 10 and pumping of the drug via needle 26 may be powered by battery 16. Optionally, if desired, needle 26 may be spring loaded, such that pressing of actuation button or any other mechanism releases the needle 26, thereby allowing it to be projected out of device 10 by action of a spring mechanism (not shown), and only pumping of the drug via the needle 26 is powered by battery 16.

Device

10 may be provided with a safety mechanism 32 intended to prevent the possibly dangerous situation resulting from inadvertent projection of the needle, for example, in the case of the actuation button being pressed accidentally. Safety mechanism 32 includes an obstruction member 34 which, in the embodiment shown, is positioned approximately in the center of top side 42 of device. It will, however, be appreciated by persons skilled in the art that, if desired, obstruction member 34 may be located at any other position on top side 42 of device 10. Obstruction member 34 is hingedly attached to housing 12 at a biased hinge 36, the hinge 36 biasing the obstruction member 34 away from an opening 38 in housing 12. Obstruction member 34 is provided with a circular aperture 40.

The safety mechanism 32 is configured such that, when in the position shown in FIG. 1, pressing of actuation button 28 may cause the needle 26 to be projected out of opening 38 and to impinge upon inner surface 35 of obstruction member 34, thereby bending needle 26. Such bending of needle 26 may render it unusable.

If, however, the top side 42 (as shown in the drawings) of device 10 is placed on the skin of a user, such as when he wants to inject the drug into his skin, contact of the user with outer surface 37 of obstruction member 34 on device 10

causes member

34 to be moved toward opening 38, in the direction of arrow 44, such that member 34 is flush with the remainder of top side 42 of device 10, and aperture 40 coincides with the projection path of needle 26 out of device 10. In this manner, member 34 does not obstruct the path of needle 26 out of device 10 and into the user's skin.

Device

10 optionally includes a processor (not shown) for controlling operation thereof. Optionally, a processor may control any or all of the functions of the device including, for example, sensing the presence of a drug vial and projecting of a needle out of the device 10.

With additional reference to FIG. 3, device 10 is also provided with a fastening mechanism 50 on top side 42, the fastening mechanism defined by an adhesive surface 52. While adhesive surface 52 is preferably configured to cover the entire top side 42 of device 10, it will be appreciated by persons skilled in the art that, if desired, adhesive surface 52 may cover only a portion of top side 42 of device. The adhesive surface 52 may optionally also cover the outer surface 37 of obstruction member 34. Alternatively, if desired, adhesive surface 52 may not cover the outer surface 37 of obstruction member 34. Adhesive surface 52 is intended to steady the device 10 on the skin of a user and to allow the user to retain the device 10 on, for example, his arm, while pressing the actuation button 28 with his other hand.

Adhesive surface

52 is provided with a cover 54 which has a size and shape similar to adhesive surface 52 and may be fabricated from any suitable material such as, for example, paper, plastic, or a laminate. If, as mentioned above, the adhesive surface 52 also covers surface 37 of obstruction member 34, cover 54 is provided with

slits

56, 57, and 58 which coincide with the location of the non-hinged

outer edges

46, 47, and 48 of obstruction member 34 and aperture 40, respectively, and, similarly, cover 54 is provided with an aperture 60 which coincides with aperture 40 in obstruction member 34.

As shown in the drawings, cover 54 may be fabricated of two

separate cover portions

54 a and 54 b, each corresponding to a portion of adhesive surface 52. Such a configuration may be advantageous as it may render cover 54 easier to remove from adhesive surface 52. Additionally, providing a cover 54 having a plurality of separate portions may facilitate removal of the cover without its tearing. The provision of a cover formed of two

separate cover portions

54 a and 54 b may provide additional advantages, as discussed further below. Alternatively, if desired, cover 54 may be fabricated of a single piece of material.

Cover

54 may be provided with a cover tab 62 which may facilitate removal of cover 54 from adhesive surface 52. Tab 62 may be formed as an extension of cover 54 and may, as in the embodiment shown, include separate

cover tab portions

62 a and 62 b on

separate cover portions

54 a and 54 b, respectively.

In accordance with an embodiment of the invention, device 10 is provided with a selectively-removable battery isolator 70. As shown in FIGS. 2 and 3, battery isolator 70 has an L-shaped configuration, including a first portion 72 disposed inside housing 12, inside battery chamber 14, between battery 16 and contact pad 18, and a second portion 76 which, in the embodiment shown, is attached to the top of adhesive cover 54, as discussed further herein. Battery isolator 70 prevents electrical contact between battery 16 and contact pad 18, thereby interrupting the battery circuit 17 of device 10, such that no power is provided to the device 10. Optionally, if desired, device 10 may be constructed such that battery isolator 70 is located at any other point along circuit 17, thereby interrupting the supply of power to device 10.

Contact pad

18 may be biased toward battery 16, thereby applying pressure in the direction of battery 16. In the embodiment shown, due to the disposition of battery isolator 70 in between battery 16 and contact pad 18, pressure will be applied by contact pad 18 to isolator 70, in the direction of battery 16.

As shown in FIGS. 1-3, L-shaped battery isolator 70 extends from inside battery chamber 14, out of an opening 74 in the top side 42 of housing 12, and terminates in a second portion 76. Isolator 70 also passes through an opening 78 in cover 54 and is fastened, for example, by gluing or welding, to the cover 54.

Optionally, instead of battery isolator 70 being attached to cover 54, battery isolator 70 may be attached to a portion of material in which the device 10 may be packaged such as, for example, protective wrapping material or blister packaging. In this manner, when a device 10 is unwrapped or when the packaging in which the device 10 is opened or removed, the battery isolator 70 may be removed from the battery chamber 14, thereby providing power to the device 10.

Isolator

70 may be fabricated of any material such as, for example, plastic, PET (polyethylene terephthalate), polycarbonate layers, or a combination thereof. Isolator 70 may be fabricated of the same material as cover 54 or, optionally, may be fabricated of a different material from that of cover 54. Preferably, in order to facilitate the removal of isolator 70 from the housing 12, the particular material may possess properties which will allow the isolator to easily slide out of the opening 74 in housing 12. For example, the thickness of the isolator may be chosen such that it has an amount of flexibility so as to allow it to easily slide out of opening 74. The thickness of the isolator may be, for example, in the range of 0.05-0.15 mm.

Additionally, first portion 72 of isolator 70 may be formed at least in part of a non-conductive material, at least at the portion thereof which is disposed along the battery circuit 17 such that it will interrupt the battery circuit, as discussed herein with reference to FIG. 4. Also, first portion 72 may be formed of a material that will not absorb moisture so as to render it electrically conductive.

It should be noted that, in the embodiment shown, each of

openings

74 and 78 is in the form of a slot, the slot sized and shaped to accommodate the battery isolator, while providing it with an unobstructed pathway via which it may be easily removed from the housing by pulling up on the adhesive cover 54, as discussed further herein.

While, in the embodiment shown, each of

openings

74 and 78 is in the form of a slot, it will be appreciated by persons skilled in the art that, if desired, any other shaped opening may be provided through which battery isolator 70 extends.

Optionally, if desired, instead of battery isolator 70 being formed as a separate piece that is fastened to the top of cover 54, battery isolator may be formed as a separate piece that is fastened to the bottom of cover 54. Alternatively, isolator 70 may optionally be formed as an extension of cover 54 and extend through opening 74 into battery chamber 14, as discussed herein. For example, during manufacture of cover 54, an extra portion of material from which the cover is formed may be left attached thereto, this extra portion of material then folded over, for example at a right angle to the cover, thereby forming an extension of the cover, the extension corresponding to first portion 72 of battery isolator 70.

As noted above, the provision of

separate cover portions

54 a and 54 b on adhesive surface 52, each cover portion having a

tab portion

62 a and 62 b, respectively, is particularly advantageous over the provision of a one-piece cover having a single tab, as discussed herein. Additionally, the particular location along the cover at which it is divided into separate portions may be significant, as will be discussed further herein. In particular, the removal of cover 54 from the adhesive surface 52, which results in removal of isolator 70 from housing 12 in accordance with embodiments of the present invention, requires a user to pull up on at least one tab, thereby applying a force to the cover (or a force to each cover portion) in a particular direction. The direction of the force applied to the cover (or cover portions) will be a combination of its components, i.e., the direction of upward pull of the tab 62 (or

tab portions

62 a and 62 b) and the direction in a plane parallel to the adhesive surface 52 in which the cover (or cover portion) is removed.

It will be appreciated by person skilled in the art that, due to the L-shaped configuration of the battery isolator 70 and the disposition of isolator first portion 72 inside housing 12, removal of first portion 72 from the housing 12 may require that a force be applied to first portion 72 having a component in a direction F₁(FIG. 3) which is substantially perpendicular to the adhesive surface 52.

If, for example, a single tab 62 on a one piece-cover 54 were positioned at the same location as shown for the two-piece tab (62 a and 62 b) shown in FIG. 3, in order to remove the adhesive cover 54 from the adhesive surface 52, a user may apply an upward force having a component in a direction F₂along the approximate center of the cover. As adhesive cover 54 is removed from adhesive surface 52, before first portion 72 of the isolator 70 is removed from housing, the second portion 76 of isolator 70 will be raised above the plane of the adhesive surface 52, together with the cover 54. As the user continues to pull up on the tab, due to the L-shaped configuration of isolator 70, removal of the portion of the cover 54 which includes the isolator second portion 76 may require the user to pull the tab upward in a direction away from the isolator, thereby twisting first portion 72 inside the housing and/or the opening 74, and thereby possibly jamming the isolator 70 inside the housing 12 and/or the opening 74. Also, due to pressure that may be applied by contact pad 18 to isolator 70, as discussed above, an additional force may be required to remove the isolator 70 from the housing, the application of this additional force causing the isolator 70 to be further twisted and/or jammed inside the housing 12 and/or the opening 74.

Optionally, there may be provided a tab, indicated by dotted lines and ref. no. 63, nearer battery isolator 70 than tab 62 shown in FIG. 3, so as to facilitate the removal of battery isolator 70 from device 10. Alternatively, the tab maybe located in the area of any other spring contact like between the batteries or the Anode side or the contact to PCB itself. All the options are acting electronically the same but may select due to mechanical constrain of specific. Specifically, in order to remove the isolator 70 from the housing 12, a force having a component in the direction of F₁is required in order to pull battery isolator 70 out of device 10, as noted above. Therefore, by positioning a tab 63 along the same side of the adhesive cover 54 as tab 62, but closer to the isolator 70, a user removing the cover 54 may apply an upward force having a component in the direction of F₂, but closer to isolator 70, for example, in the direction F₃. Therefore, as adhesive cover 54 is removed from adhesive surface 52, before first portion 72 of the isolator 70 is removed from housing, the second portion 76 of isolator 70 will be raised above the plane of the adhesive surface 52, together with the cover 54. As the user continues to pull up on the tab 63, due to the fact that the upward force applied to tab 63 is in the direction of the isolator and has components in the directions of F₁and F₃, removal of the portion of the cover 54 which includes the isolator second portion 76 is facilitated, thereby preventing twisting and/or jamming of first portion 72 inside the housing and/or the opening 74.

Alternatively, if desired, instead of providing adhesive surface 52 with a one-piece cover 54 having a single tab thereon, a pair of

cover portions

54 a and 54 b may be provided, whereby each cover portion is provided with a

respective tab portion

62 a and 62 b. This configuration of the cover may facilitate removal of the isolator 70 from device 10, while preventing its twisting and/or jamming, as discussed herein. In particular, as shown in FIG. 3, due to the provision of two

separate tab portions

62 a and 62 b, in accordance with embodiments of the invention, for each tab portion the user may apply an upward force, each having a respective component, F_aand F_b, each in a direction of the approximate center of the respective tab portion. For cover portion 62 a, to which isolator 70 may be fastened, application of an upward force having a component F_ato tab portion 62 a will achieve removal of cover portion 54 a from adhesive surface 52. As cover portion 54 a is removed, the tab portion 62 a may be pulled upward in a direction toward the isolator 70. Before first portion 72 of the isolator 70 is removed from housing 12, the second portion 76 of isolator 70 may be raised together with cover portion 54 a above the plane of the adhesive surface 52 until it is substantially perpendicular thereto. As the user continues to pull tab portion 62 a upward, the cover portion 62 a is pulled by a force having components in the directions F_aand F₁, whereby the isolator will be removed from opening 74 without twisting and/or jamming therein.

It will be appreciated by persons skilled in the art that, in addition to the provision of

separate cover portions

54 a and 54 b, the particular point of division of the cover 54 into separate portions may be chosen such that the cover portions may be removed without the isolator becoming twisted and/or jammed in the device, as discussed above.

As noted above, the particular slot size and width of opening 74 in housing 12 and opening 78 in cover 54 may be chosen so as to prevent twisting and/or jamming of the isolator portion 72 inside the housing 12, thereby facilitating its removal from the device 10. Preferably, an isolator first portion 72 may be 10 mm wide by 30 mm long, wherein the width corresponds substantially to a battery diameter and the length corresponds to a length allowing the isolator to extend out of the housing 12 and onto the cover 54. Opening 74 may be wider than the width of isolator first portion 72. For example, opening 74 may be approximately 2 mm wide. Also, opening 74 may have a thickness which is substantially greater than that of the isolator first portion 72. The thickness of opening 74 may be, for example, 1 mm.

FIG. 5 illustrates a method 100 for selectively powering a battery-operated drug-delivery device having a battery circuit and injecting the drug into a user, in accordance with the present invention. The results of actions according to the method are also illustrated. According to the method 100, as shown at 102, a battery isolator is in a first position, whereat it interrupts the battery circuit. As a result of the battery circuit being interrupted, no power is provided to the device, as shown at 104. As shown at 106, removal of a cover from an adhesive surface of the device causes a fastening mechanism of the device to be activated, as shown at 108, whereby the device may be fastened to the skin of a user. Removal of the adhesive cover also causes movement of the battery isolator to a second position whereat the battery circuit is uninterrupted by the isolator, such that power is provided to the device, as shown at 110. Optionally, after removal of the adhesive cover together with the battery isolator, if desired, the adhesive cover together with the battery isolator may be discarded.

It should be noted that the simple mechanical action 106 of removing the cover 54 from the device 10 results in completion of the battery circuit 17 (FIG. 4). This provides the device with an easy to use method of powering the device, as will be appreciated by persons skilled in the art. Once power has been supplied to the device, it may be operated as required for the injection of a drug. Specifically, once power has been supplied to the device, a user may press on the actuation button 28 (FIG. 1), thereby causing a needle to be projected out of the device and causing a drug to be pumped out of the device, as discussed herein. As discussed above, operation of device 10 may be controlled by a processor or, optionally, device 10 may not include a processor.

As discussed above, the present invention, in embodiments thereof, provides an isolator 70 which may be attached to the cover 54 (or cover

portions

54 a and 54 b) of the adhesive surface 52, thereby providing a user with a simple mechanism for removing the isolator 70 while fastening the device 10 to his skin. Therefore, aside from removing the cover 54 from the adhesive surface 52, which is an action required to operate the device 10, there are no additional actions that the user is required to perform. The invention, in embodiments thereof, therefore provides a simple, effective mechanism for completing a battery circuit of a device.

Optionally, in addition to device 10 being provided with battery isolator 70, the device may be additionally provided with a second battery isolator (not shown), thereby requiring the removal of both isolator 70 and the second battery isolator in order to power the device. For example, an additional battery isolator may be attached to or continuous with obstruction member 34 (FIG. 1), in a manner similar to that discussed herein with regard to isolator 70. Therefore, both the action of pressing down on the obstruction member 34 (FIG. 1), and the action of removing adhesive cover 54 (or cover portion 54 a), as discussed herein, may be required in order to complete battery circuit 17 (FIG. 4), thereby powering device 10.

It will be appreciated by persons skilled in the art that, in accordance with embodiments of the present invention, any combination of actions required to operate device 10, such as the actions of removing the adhesive cover, pressing down on the obstruction member 34, pressing of an actuation button 28, and closing cover 25 on drug vial compartment 24 may be required in order to power the device 10. It should be noted that, by requiring these actions, either individually and in combination, in order to power the device, as discussed herein, device 10 is provided with a simple mechanism for selectively completing battery circuit 17, requiring no action in order to remove battery isolator 70 from the device 10, other than the action(s) required to operate the device 10.

It is expected that during the life of a patent maturing from this application many relevant battery isolators will be developed and the scope of the term battery isolator is intended to include all such new technologies a priori.

The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to.”

The term “consisting of means “including and limited to”.

The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

What is claimed is:

1. A selectively powered battery-operated drug-delivery device comprising:

a unitary housing having a battery and a complete battery circuit therein;

a needle disposed within said housing and projectable at least partially out of said housing for administering a drug within said housing to a user;

a selectively-removable isolator, said isolator disposed in a first position whereat said isolator contacts a battery terminal within said housing so as to interrupt the complete battery circuit, such that no power is provided to the device;

said isolator configured to be movable to a second position whereat the complete battery circuit is uninterrupted by said isolator, such that power is provided to the device; and

an adhesive surface disposed along a side of the unitary housing, configured for fastening the device to the skin of the user, said adhesive surface being provided with a selectively removable protective cover, said isolator being an integral extension of the protective cover extending into the housing in the first position, whereby removal of the protective cover moves the isolator from the first position to the second position, thereby connecting the complete battery circuit to provide power to the device.

2. A device according to claim 1, wherein said housing includes an opening through which said isolator extends when in said first position.

3. A device according to claim 2, wherein said opening comprises a slot.

4. A device according to claim 2, wherein said isolator extends from outside said housing, through said opening.

5. A device according to claim 1, wherein said protective cover includes a tab configured to facilitate removal of the protective cover from said adhesive surface.

6. A device according to claim 1, wherein said protective cover includes a single portion configured to cover the entire said adhesive surface.

7. A device according to claim 1, wherein said protective cover includes at least two portions, each portion configured to cover a corresponding portion of said adhesive surface.

8. A device according to claim 7, wherein each of said at least two cover portions includes a tab configured to facilitate removal of the said cover portion from said adhesive surface.

9. A device according to claim 2, further comprising an actuation button for projecting the needle at least partially out of the housing for engaging the skin of the user and pumping the drug out of the housing via the needle upon pressing thereof, wherein said actuation button is powered by said battery.