The present invention relates generally to a safety feature for an infusion device, and in particular, for a wearable infusion device such as a patch pump, wherein the safety feature prevents inadvertent activation of the infusion device.
Devices for delivering medicament to a patient are known in the art. One type of drug delivery device is identified as a wearable infusion device or patch pump. These devices are intended for attachment to a patient's skin for self-administration of a medicament, such as insulin. Wearable infusion devices are generally intended for patients who prefer only a single needle insertion in a 2-3 day period, rather than 8-12 normal insulin injections in the same period. The advantage of wearable infusion devices is that the patient is subjected to fewer needle sticks than other delivery methods, such as a syringe or an injection pen.
When the wearable infusion device is attached to a patient's skin and activated, a hollow needle from the infusion device is injected into the patient's skin, and a drive mechanism to administer the medicament to the patient via the needle is actuated. Typically, in an infusion device, the needle is in communication with a reservoir containing the medicament. U.S. Pat. No. 5,858,001 to Tsals et al., incorporated herein by reference, discloses an infusion device which is activated by a swivel action of a main body containing a reservoir of medicament in relation to a member attached to a patient's skin. Upon activation, the device of Tsals et al. is primed and causes a needle to penetrate the skin of a patient and administer the medicament. The needle remains attached to the skin until the device is removed. Other types of infusion devices are known in the art.
In some infusion devices, activation can be awkward or imprecise, causing discomfort to the user. For instance, in the device of Tsals et al., a pivoting action of a main body containing the medicament reservoir and the needle against a member attached to the patient's skin is required, which requires additional space for activation, possible discomfort to the user, possible exposure of the needle to unwanted contact, and other related problems. Prior art infusion devices may also be prone to accidental activation since they sometimes lack safety devices that can prevent accidental activation.
Accordingly, a need exists for an improved infusion device, particularly a wearable infusion device, in which activation of the device is discrete, sanitary and accurate, and that minimizes the likelihood of unintended activation.
An object of the present invention is to provide an infusion device, particularly a wearable infusion device, that is capable of precise activation, the infusion device having a safety feature to minimize the likelihood of accidental activation, while providing optimal comfort of use and convenience to the user.
This and other objects are substantially achieved by providing an infusion device with a safety feature that is intended to prevent accidental activation of the infusion device, wherein the safety device conforms to the shape of the infusion device to minimize bulkiness and discomfort to the user.
The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which:
The wearable infusion device 1 includes a main body 10 in which a reservoir (not shown) is housed. The reservoir is filled with a required amount of liquid medicament, typically insulin, sufficient to deliver insulin to the user for an extended period, e.g. 2-3 days. An adhesive liner 3 is attached to the back surface of the infusion device 1 and can adhere to the skin of a user at a location suitable for insulin therapy, such as the abdomen.
The infusion device 1 houses a hollow delivery needle (not shown) for delivering liquid medicament from the internal reservoir to the user via the needle. The infusion device 1 also includes a drive mechanism (not shown) for priming the delivery needle such that medicament flows to the needle from the reservoir, and for driving the delivery needle into the user's skin to deliver the medicament to the user. In order for the delivery of medicament to the patient to occur, the user/patient attaches the infusion device 1 to his or her skin via the adhesive liner 3 and activates a push button 15, which actuates the drive mechanism to insert the needle to the user's skin and deliver insulin to the patient.
The infusion device 1 also includes a safety feature for preventing accidental activation of the push button 15. The safety feature includes a wall portion 12 that protrudes from the main body 10 and that is preferably positioned near the push button 15, as illustrated in
The safety cover 2 is slidable on the main body 10 to expose the push button 15, so that the user can intentionally push the push button 10 at the appropriate time. In one embodiment, the main body 10 includes guide rails 11a, 11b on the upper and lower sides of the main body 10 (see
In another embodiment, the guide rails 11a, 11b on the main body 10 and the corresponding grooves 23 on the safety cover 2 may be replaced with magnets (not shown) for attaching and/or sliding the safety cover 2 to the main body 10. The use of magnetic forces can accurately position the safety cover 2 in relation to the push button 15. In another embodiment, the main body 10 includes one or more magnets (not shown) and the safety cover 2 includes corresponding metallic or magnetic structures (not shown), such that the safety cover 2 is attachable to the main body 10. In yet another embodiment, the safety cover 2 includes one or more magnets (not shown) and the main body 10 includes corresponding metallic or magnetic structures (not shown), such that the safety cover 2 is attachable to and slidable on the main body 10. As illustrated in
In one embodiment, as illustrated in
To assist in maintaining the safety cover 2 at the first position, in which the safety cover 3 shields the push button, as illustrated in
The protruding wall portion 12 is preferably configured around a periphery of the push button 15. For instance, the wall portion 12 can be a half-moon shape that recedes at its ends, as illustrated in
With the cover 2 removed, as illustrated in
When the push button 15 is actuated, the delivery needle (not shown) extends from a back surface of the main body 10 of the infusion device 1. As illustrated in
Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.
This application claims priority under 35 USC §119(e) from U.S. Provisional Patent Application Ser. No. 61/624,214, filed on Apr. 13, 2012, the disclosure of which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2013/036391 | 4/12/2013 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2013/155426 | 10/17/2013 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5858001 | Tsals | Jan 1999 | A |
7780639 | Van Lue | Aug 2010 | B2 |
20040025877 | Crowder | Feb 2004 | A1 |
20040116847 | Wall | Jun 2004 | A1 |
20080125065 | Das | May 2008 | A1 |
20090240240 | Hines | Sep 2009 | A1 |
20090326472 | Carter et al. | Dec 2009 | A1 |
20110112484 | Carter et al. | May 2011 | A1 |
Number | Date | Country |
---|---|---|
2739926 | Nov 2005 | CN |
101478999 | Jul 2009 | CN |
WO-2011084951 | Jul 2011 | WO |
Entry |
---|
Chinese Office Action dated Apr. 28, 2016 that issued in counterpart Patent Application No. 201380026302.X. |
Number | Date | Country | |
---|---|---|---|
20150080799 A1 | Mar 2015 | US |
Number | Date | Country | |
---|---|---|---|
61624214 | Apr 2012 | US |