Patent Publication Number: US-2023145128-A1

Title: Skin sensor triggering signal

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to an automated medicament delivery device, and more particularly to such a device having a skin sensor for detecting whether the medicament delivery device has been detached or removed from the skin of the user. 
     BACKGROUND 
     Medicament delivery devices for self-administration have been on the market for a number of years. In order for the devices to be handled by non-professionals, they have to be easy to use and intuitive. Further, since many of the drugs are vital or at least very important to the patient there is a desire from physicians and other professionals to obtain information that the patients medicate according to prescribed schemes. The desired information could include the type of drug, delivery times and dates, dose size. Additional information that could be beneficial to the physician is that the drug has being taken using the correct procedure according to instructions for use; that the drug has the prescribed temperature during drug delivery; that the right injection depth has been used and that the correct injection speed has been used, when the medicament delivery device is an injector. 
     In order to obtain this information from the medicament delivery device, a number of solutions have been presented, including communication mechanisms which will enable wireless communication with a remote terminal device such as a cellular or a mobile phone. However, the human body has a negative effect on antenna performance. Therefore, it is harder for the medicament delivery device to make a strong wireless connection with a remote terminal device when the medicament delivery device is attached to the user. As such, there is a need to know when the medicament delivery device has been detached from the skin of the user in order to establish a successful wireless communication with a remote device with minimal power dissipation. 
     SUMMARY 
     The present disclosure relates to a device and methods of use for detecting whether a medicament delivery device has been detached or removed from a user such that a signal is triggered and information about the status of the medicament delivery device can be sent. 
     In particular, the present disclosure provides a medicament delivery device comprising: (a) a housing having a first region and a second region, wherein the housing is configured to receive a medicament container containing a medicament, (b) a delivery needle extending from the second region of the housing, wherein the delivery needle is configured to penetrate a skin of a user to thereby deliver the medicament from the medicament container into the user, (c) a skin sensor positioned at least partially within the housing, (d) a transmitter positioned within the housing, (e) at least one memory storage element including unique identification data associated with the medicament delivery device and/or the user, (f) at least one processor, and (g) data storage including program instructions stored thereon that when executed by the at least one processor, cause the medicament delivery device to: (i) determine, via the skin sensor, whether or not the medicament delivery device is attached to the skin of the user, (ii) in response to a determination that the medicament delivery device is attached to the skin of the user, prevent transmission of the unique identification data from the transmitter, and (iii) in response to a determination that the medicament delivery device is not attached to the skin of the user, transmit, via the transmitter, the unique identification data to one or more external receivers. 
     These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    illustrates a simplified block diagram of a medicament delivery device, according to an example embodiment. 
         FIG.  2 A  illustrates a top perspective view of a medicament delivery device, according to an example embodiment. 
         FIG.  2 B  illustrates a bottom perspective view of the medicament delivery device of  FIG.  2 A , according to an example embodiment. 
         FIG.  3    is a schematic drawing of a wireless communication system, according to an example embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The example embodiments described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein. 
     Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example embodiment may include elements that are not illustrated in the Figures. 
     Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item. 
     As used herein, apparatus, element and method “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the apparatus, element, and method “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, “configured to” refers to existing characteristics of an apparatus, element, and method which enable the apparatus, element, and method to perform the specified function without further modification. For purposes of this disclosure, an apparatus, element, and method described as being “configured to” perform a particular function can additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function. 
     Further, in the following description, the wording medicament delivery device will be used. In this context, medicament delivery devices may include a number of devices capable of delivering certain doses of medicament to a user. The medicament delivery devices may be of either disposable type or re-usable type and may be provided with medicament containers suitably arranged for specific drugs in specific forms. 
     With reference to the figures,  FIG.  1    illustrates a simplified block diagram of a medicament delivery device  100 , according to an example embodiment. As shown in FIG.  1 , the medicament delivery device  100  includes a housing  102  having a first region  104  and a second region  106  The housing  102  is configured to receive a medicament container  108  containing a medicament  110 . In one example the first region  104  is located on one side of the housing  102 , and the region  106  is located on another side of the housing  102 . The medicament delivery device  100  also includes a delivery needle  112  extending from the second region  106  of the housing  102 . The delivery needle  112  is configured to penetrate a skin of a user to thereby deliver the medicament  110  from the medicament container  108  into the user. The medicament delivery device  100  also includes a skin sensor  114  positioned at least partially within the housing  102 , and a transmitter  116  positioned within the housing  102 . In some examples, the medicament delivery device  100  also includes an antenna  117  operably connected to the transmitter  116 . 
     As further shown in  FIG.  1   , the medicament delivery device  100  further includes at least one memory storage element  118 . The at least one memory storage element  118  includes unique identification data associated with the medicament delivery device and/or the user. Such unique identification data may comprise information including a type of medicament  110  in the medicament delivery device  100 , historical delivery times and dates, historical dose sizes, a most recent delivery time and dose size, and additional patient information. The unique identification data may be compared with prescribed drug delivery intervals and/or dose sizes in order to detect any deviations. Any deviations may then be transmitted to the physician of the user for follow up. 
     The medicament delivery device  100  further includes at least one processor  120 , and data storage  122  including program instructions  124  stored thereon that when executed by the at least one processor  120 , cause the medicament delivery device  100  to perform functions. In one example, at least one processor may be a field programmable gate array (FPGA). In particular, the functions include (i) determining, via the skin sensor  114 , whether or not the medicament delivery device  100  is attached to the skin of the user, (ii) in response to a determination that the medicament delivery device  100  is attached to the skin of the user, prevent transmission of the unique identification data from the transmitter  116 , and (iii) in response to a determination that the medicament delivery device  100  is not attached to the skin of the user, transmit, via the transmitter  116 , the unique identification data to one or more external receivers. One advantage of the functions (i, ii iii) is a lower power consumption, as transmittal failure and reattempts for transmitting the unique identification data to one or more external receivers may be reduced. Transmittal failures may can be more likely when the delivery device  100  being attached to the user. The user&#39;s body may have a screening effect on the antenna  117 . A lower power consumption may eventually have an impact on manufacture costs with reduced power needs, as less, less powerful or smaller parts needed. 
     In one example, such external receivers may comprise smart devices. In this context, smart devices may include electronic devices that are provided with processors that are capable of running computer programs as well as storage space to store programs as well as data retrieved from different external sources. It is further to be understood that the smart devices are provided with communication systems that are capable of communicating with data networks in order to access different databases. It is to be understood that databases may be accessed via the internet, so called cloud services, and/or databases that are connected directly to and accessed via local area networks. It is further to be understood that the smart devices in this context comprise some sort of human-machine interface for two-way communication. The human-machine interface may comprise displays, keyboards, microphones, loudspeakers, I/O-ports for connection of peripherals. Further the smart devices may be provided with antennas for wireless communication with the networks. Also, the smart devices may be arranged with receiving and transmitting mechanisms capable of communicating with near-field communication (NFC) tags as well as programs capable of establishing and handling the communication with the NFC tags. 
     The skin sensor  114  may take a variety of forms. In particular, the skin sensor  114  may comprise one or more of a capacitive sensor, a temperature sensor, an ambient light sensor, a pulse oximeter, a heart rate sensor, or an inertial measurement unit (e.g., an accelerometer and gyroscope). The skin sensor  114  is configured to determine whether the medicament delivery device  100  is attached to the skin of the user. The skin sensor  114  may make such a determination constantly, or the skin sensor  114  may make such a determination periodically (e.g., every 1 minutes, every 5 minutes, or every 10 minutes). One advantage of the skin sensor  114  making such determination constantly or periodically may be that as the medical device  100  may be attached to the user with for example on behalf a wrist band, and a predetermined time laps after the activation button was launched may not determine if the medical device has been detached from the user. In one example, the skin sensor  114  is configured to contact the skin of the user when the medicament delivery device  100  is attached to the skin of the user. In another example, the skin sensor  114  is configured to be spaced away from the skin of the user when the medicament delivery device  100  is attached to the skin of the user. 
       FIG.  2 A  illustrates a top perspective view of the medicament delivery device  100 , according to an example embodiment. As shown in  FIG.  2 A , the first region  104  of the housing  102  may include an activation button  126 . In use, a user translates the activation button  126  to inject the medicament  110  though the delivery needle  112  and into the user. 
       FIG.  2 B  illustrates a bottom perspective view of the medicament delivery device  100  of  FIG.  2 A , according to an example embodiment. As shown in  FIG.  2 B , the second region  106  of the housing  102  may include a cutout  128 . In such an example, the skin sensor  114  is positioned in the housing  102  such that the skin sensor  114  is aligned with the cutout  128  in the second region  106  of the housing  102 . 
       FIG.  3    is a schematic drawing of a communication system  200 , according to an example embodiment. In the communication system  200 , a computing device  202  communicates with the medicament delivery device  100  using a wireless communication link  204 . The computing device  202  may be any type of device that can receive data and display information corresponding to or associated with the data. For example, the computing device  202  may be any external receiver, including a smart device (e.g., a mobile phone, a tablet, or a personal computer as non-limiting examples). 
     Thus, the computing device  202  may include a display system  206  comprising a processor  208  and a display  210 . The display  210  may be, for example, an optical see-through display, an optical see-around display, or a video see-through display. In response to a determination that the medicament delivery device  100  is not attached to the skin of the user, the medicament delivery device  100  transmits, via the transmitter  116 , unique identification data for receipt by the computing device  202 . In particular, the processor  208  may receive the data unique identification data from the medicament delivery device  100 , and configure the data for display on the display  210 . Depending on the desired configuration, processor  208  can be any type of processor including, but not limited to, a microprocessor, a microcontroller, a digital signal processor, or any combination thereof. 
     The computing device  202  may further include on-board data storage, such as memory  212  coupled to the processor  208 . The memory  212  may store software that can be accessed and executed by the processor  208 , for example. The memory  212  can include any type of memory now known or later developed including but not limited to volatile memory (such as RAM), non-volatile memory (such as ROM, flash memory, etc.) or any combination thereof. 
     According to an example embodiment, the computing device  202  may include program instructions that are stored in the memory  212  (and/or possibly in another data-storage medium) and executable by the processor  208  to facilitate the various functions described herein. Although various components of the communication system  200  are shown as distributed components, it should be understood that any of such components may be physically integrated and/or distributed according to the desired configuration of the computing system. 
     The medicament delivery device  100  and the computing device  202  may contain hardware to enable the wireless communication link  204 , such as processors, transmitters, receivers, antennas, etc., as discussed above. 
     In one example, the wireless communication link  204  may comprise near-field communication (NFC) technology, Bluetooth® radio technology, communication protocols described in IEEE 802.11 (including any IEEE 802.11 revisions), Cellular technology (such as GSM, CDMA, UMTS, EV-DO, WiMAX, or LTE), or Zigbee® technology, among other possibilities. 
     In use, the skin sensor  114  detects (either constantly or periodically) whether or not the medicament delivery device  100  is attached to the skin of the user. In one example, the skin sensor  114  begins detecting whether or not the medicament delivery device  100  is attached to the skin of the user after the medicament delivery device  100  determines that a dose of medicament  110  from the medicament container  108  has been delivered to the user. If a determination is made that the medicament delivery device  100  is still attached to the skin of the user, transmission of unique identification data from the transmitter  116  is prevented. However, if a determination is made that the medicament delivery device  100  is not attached to the skin of the user, the unique identification data is transmitted from the transmitter  116  to one or more external receivers. Such a process helps to establish a successful wireless communication between the medicament delivery device  100  and a remote device with minimal power dissipation. 
     It will be appreciated that other arrangements are possible as well, including some arrangements that involve more or fewer steps than those described above, or steps in a different order than those described above. 
     While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of the devices and methods can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the claims.