CN101198366A - Methods and devices for assisting patient self-administration - Google Patents

Abstract

The invention relates to a manual injection pen (1) suitable for injecting liquid medicine through a non-electric mechanism (33). The injection pen (1) has a plurality of sensors (50, 70, 200) which sense when a user takes a specific action with the device. In addition, the injection pen (1) is also equipped with a sound generator (10), which can emit specific sounds corresponding to specific actions taken by the user. In this way, a specific sound signal can be emitted for each specific action.

Description

Methods and devices for assisting patient self-administration

technical field

The present invention generally relates to the treatment of disease and treatment in the context of patient self-administration. In particular, the present invention relates to a device and method for making self-administration easy and/or enjoyable. The present invention also relates to methods of administering drugs and methods of marketing devices and medicaments to patients. This is especially useful for patients who have to inject their own medicine, but it is not meant to be limited to injection devices.

Background technique

Many diseases, such as diabetes and growth disorders, often require patient self-administration. In many cases, the drug cannot be taken orally. Although many new routes of administration have been developed, self-injection of these drugs is often still required; in particular, there is currently a strong push for pulmonary delivery of insulin. While devices are currently available for self-injecting or inhaling medication, such devices generally do not incorporate user-friendly feedback. Although some infusion pumps include some alarm systems, generally discrete dose metering devices such as injection pens do not provide much information to the user in the form of audible feedback. Typically, such pens include only a very simple mechanical click mechanism that "clicks" for each increment set on the pen.

Contents of the invention

The present invention improves the patient's experience with self-administration. In one embodiment, a drug delivery device, such as an injection pen, has a speaker or other output device capable of delivering audible, visual and/or tactile feedback to the patient. For example, in one embodiment, the device emits a sound when the user initially touches the device, when the user changes a setting, or when a drug is successfully delivered from the device.

While the present invention may include electromechanically driven drug delivery devices, it may also include low complexity devices that rely on purely mechanical components to deliver the drug.

In some embodiments, the emitted sound may be selected by the user from a variety of sounds, or downloaded to the device from an external source or computer network such as the Internet.

In one of its embodiments, the invention is embodied as a drug delivery device, such as an injection pen. The pen has one or more sensors that sense when the user starts using the pen or even just touches the pen. The sensors can detect various actions taken by the user. These actions include picking up the pen, removing the cap, attaching to the needle, adjusting the dose, inserting the needle into the user's skin, injecting the dose, removing the needle from the user's skin, replacing the cap, etc. . The device includes a voice chip or other electronic or mechanical mechanism that can produce sound. The device also includes an interface that allows the voice mode to be downloaded to the device.

In one of these embodiments, various voice modes are pre-loaded into the device. The speech mode may be selected based on the intended user of the device. For example, in an injection pen marketed to children, the sounds could be made to mimic the sounds of popular children's cartoons or from other areas of popular children's culture. Thus, this aspect of the invention is one of many methods that may be useful in vending a device and/or vending a drug contained within a device for a particular patient population.

In another embodiment, the present invention can provide a means of educating the user on the proper operation of the device. For example, when the present invention is incorporated into a pen device, the user can be taught to properly operate the pen through synthesized voice commands. Even when the patient is sufficiently trained to use this particular device, the present invention is useful in alerting the patient, for example by leaving the needle under the skin for a predetermined time after injection, alerting the user that their drug supply is running low, or Reminds the user that the drug is running low.

Description of drawings

Figure 1 shows an exemplary embodiment of the present invention in the form of an injection pen.

Detailed ways

In this exemplary embodiment, the invention is incorporated into a standard injection pen, such as an insulin injection pen. Such injection pens are disclosed in US patents US6277098, US6302855, US6248090, US6004297, US6235004, and US5626566, the entire contents of which are incorporated herein by reference.

As shown in Figure 1, the pen 1 has a mechanical dose setting mechanism 11 and a mechanical drive mechanism 33 for expelling medicine from the pen. This pen includes a processor 10, a speaker 20 connected to the processor and a user Input section 30,40. The user input is used to control volume or other functions, such as controlling a switch.

The pen may also include various sensors, such as a tactile sensor 50 that responds when the user touches the pen. The tactile sensor 50 can be any sensor that reacts when it is in contact with a user, such as a pressure sensor, an impedance change sensor, a resistance sensing system or other devices that can detect when in contact. In addition, the pen 1 also includes a number of other sensors for detecting the movement of various components. For example, the injection pen 1 may include a cap removal sensor 70 that senses when the cap 100 is removed.

Additionally, other sensors may also be incorporated into the dose setting mechanism and triggered by setting the dose. These sensors may be moving contacts or rely on magnetic contacts or other types of sensors that sense movement of the dose setting mechanism. Furthermore, the pen 1 also includes a needle insertion type sensor 200 connected to the injection needle so that it is triggered when the needle is inserted into the skin surface. Typically, these sensors are connected to the processor 10 so that when the sensor is triggered, a signal is sent to the processor. The processor 10 is configured to generate sound or to be connected, linked or cooperated with a sound generating device such as a sound cart to generate a sound signal capable of driving a speaker 20 .

In this embodiment, all sound signals sent to the speakers are identical. In another embodiment, the sound signal can vary depending on which sensor is triggered. For example, removing the cap 100 produces one sound, rotating the dose setting mechanism produces a different sound, and inserting the needle into the skin produces yet another sound.

If the pen 1 contains a needle insertion sensor 200, the processor can be programmed to warn the user with an audible prompt when the needle is removed from the skin. This time can be programmed to correspond to the time required to keep the needle in the skin after injection (eg 10 seconds, typically 4-8 seconds).

In some embodiments, delivery devices incorporating the present invention may also include visual or tactile displays. Thus, the processor can display a selection menu for the user, and the user can select an option through the user input part 30 .

Some embodiments may also include an input unit 300 that allows the user to download audio signals, such as music, into the pen 1 . The input is configured to allow wired downloading or to accept wireless communication with an external device, such as a personal computer or a network such as the Internet.

In some embodiments, the patient can be alerted using a sound or a patient feedback system. For example, the device can be configured to sound or send other audible or visual signals or tactile reminders to the patient when the device has not been used for a period of time. For example, if the device is not used in the morning, the device emits an audible signal. Other reminders, such as failure to deliver the normal daily dose can also trigger the sound. Multiple sounds can be used for different reminders. Accordingly, the present invention can be used to increase patient compliance and thus improve patient treatment and outcomes.

Example 1

A pen can be constructed as shown in FIG. 1 . Additionally the following can also be incorporated into this pen. The pen is preloaded with music from popular children's movies about fictional toys that come true. The hero in the movie is a space toy that can make special sounds. In particular, the hero is able to make specific sounds in lasers when being shot, and will say unique mottos as it goes on adventures.

In this embodiment, when the cap is removed from the pen, the pen makes a laser sound similar to the hero's laser sound when being shot. When the user adjusts the dose, another sound similar to that produced while watching a movie is produced. Another sound is emitted from the pen as the user inserts the needle into the surface of the skin. This sound can reassure the user, telling him that the painful part is over, or that the user is "very brave" or other words or sounds of encouragement. When enough time has passed and the needle needs to be pulled out, the pen will emit the Hero Toys motto.

Example 2

According to Embodiment 1, it is possible to make a TV commercial to show children using the injection pen. Television commercials may be displayed during and before and after the movie that provides the sound for the pen. Since the movie is aimed at children, the ad is also aimed at children. Assuming a sufficient audience of children, the potential number of children who would view the ad and need the pen can be calculated. Thus, the present invention can provide a method of introducing children and their parents to new drug delivery technologies by watching children's television or movies so that those in need can be helped.

Claims (5)

1. A manual injection pen (1) for injecting liquid medicine through a non-electric mechanism (33), characterized in that the pen (1) includes: a. one or more sensors (50, 70, 200) that sense when a user takes an action with the device, and b. A sound generator (10) that emits specific sounds corresponding to specific actions taken by the user. 2. The manual injection pen according to claim 1, characterized in that the sounder (10) comprises a processor (10). 3. Manual injection pen according to claim 1 or 2, characterized in that the sounder (10) is capable of providing audible indications to the patient using the pen. 4. The manual injection pen according to claim 2 or 3, characterized in that the processor (10) receives signals from a plurality of sensors (50, 70, 200), and according to the combination of the received signals Sound or audible indication. 5. The manual injection pen according to any one of claims 1 to 4, characterized in that the manual injection pen (1) further comprises an input part allowing sound files to be downloaded into the sound generator (10).

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