Patent Application
20160029977
The present invention relates generally to continuous glucose monitoring (CGM) devices used to continuously monitor subcutaneous glucose using optical interrogation of a glucose binding protein (GBP) to determine the concentration of glucose in a user. More particularly, the present invention relates to on-body sensors (OBS) incorporating CGM devices and having covers with integrated output displays.
In patients with diabetes, glucose levels need to be monitored to maintain a healthy balance of glucose in the body. Glucose levels can be monitored by GBP coated sensors such as on-body CGM devices. CGM devices can have a needle or probe that is inserted into the tissue of a user to measure the glucose levels in the surrounding tissue fluid.
Conventionally, on-body CGM devices are usually small and configured to be secured to the skin of a user's abdomen during each sensor wear period. A transmitter is incorporated into the CGM device and communicates with a handheld receiver. The data collected by the CGM device is transferred to the receiver at intervals throughout the wear period.
Without a display incorporated into the OBS, a user must carry a separate device to inspect the information obtained by and/or processed by the CGM device. Therefore, a patient often does not have the benefit of knowing current glucose levels or trends due to not having a data receiving device to receive, process and display the data from the CGM device.
It is also important to maintain a low profile CGM device in order to reduce interference with the activities of the user and reduce possible skin irritation. Without a low profile CGM device normal body movement of a user can cause unwanted micro-motion of the needle or probe which can compromise the data collected by the CGM device. Additionally, the shape and exterior configuration of the on-body CGM device can catch on a user's clothing causing additional irritation to the user and even malfunction of the device itself.
An object of illustrative embodiments of the present invention is to substantially address the above and other concerns, and provide improved structure to OBS devices.
Another object of illustrative embodiments of the present invention is to provide an OBS device that will provide an on-body output display.
Another object of illustrative embodiments of the present invention is to provide an on-body display that can be conveniently inspected by a user in multiple positions.
Another object of illustrative embodiments of the present invention is to provide an on-body display that maintains an overall low profile of the OBS such that interference with the movements of a user is minimized.
Another object of illustrative embodiments of the present invention is to allow a patient to move freely while maintaining the proper positioning of the OBS device.
Another object of illustrative embodiments of the present invention is to enable the OBS device to flex and move with the user, but reduce micro-motions of the needle that can cause malfunction of the OBS and injure the user.
These and other objects are substantially achieved by providing an illustrative OBS cover for a CGM device wherein the cover includes an integrated on-body output display having a reduced profile while maintaining structural and positional integrity, thereby improving the effectiveness, comfort, durability and securement of the OBS device.
The various objects, advantages and novel features of illustrative 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:
As will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements and arrangements of CGM devices disclosed herein. Although reference will be made to the illustrative embodiments depicted in the drawings and the following descriptions, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed invention.
The LED 24 emits light that is selectively filtered by a filter 26 fixed to a top surface of the LED 24. The optical coupler 12 is positioned above the LED 24 and photodiode 22 and directs the light emitted from the LED 24 into a fiber 28 positioned adjacent to the LED 24. The fiber 28 runs through the length of a needle 30. The needle 30 is used to insert the fiber 28 into a user to provide contact between the fiber 28 and biomaterial, such as GBP, beneath the skin of the user. The GBP coats or is deposited on the end of the needle 30 and contacts blood or interstitial fluid (ISF) after insertion into the user.
The optical coupler 12 includes a plastic connector 33 having three integral lenses, an LED lens 32, a fiber lens 34 and a detector lens 36. The plastic connector also includes a pair of inclined glass mounting surfaces 37 and a mirrored surface 39 that reflects light emitted from the LED 24 through the fiber lens 34 and into the fiber 28 to transmit light to the GBP. The glass mounting surfaces 37 are configured to support and fix filters at a predetermined angle with respect to the photodiode 22, the LED 24 and the fiber 28. The plastic connector 31 can be manufactured as a single injection molded component, reducing the number of individual parts of the optical coupler 12 that need to be manufactured and assembled. The plastic connector 31 can also be formed by other desired manufacturing processes capable of forming a single unitary component.
The optical coupler 12 includes a first glass filter 38 and a second glass filter 40. The first glass filter 38 is fixed to the second glass filter 40 via gluing or another desired securing mechanism. The glued first and second glass filters 38 and 40 are also fixed or glued to the inclined glass mounting surfaces 37. After the first and second glass filters 38 and 40 are fixed together, only two components need to be positioned during assembly, the fixed glass filters 38 and 40 and the inclined surfaces of the 37 of the optical coupler 12. This simplified assembly reduces possible misalignment of components and potential failure of the CGM sensor 10. Additionally, by fixing the first and second glass filters 38 and 40 together and then directly fixing them to the inclined surfaces of the optical coupler 12, less light is lost and/or diffused during operation, thereby improving the efficiency of the optical coupler 12, as opposed to other known optical couplers that require the light to travel in and out of more open air spaces which cause increased inefficiency in light transfer.
The first glass filter 38 includes a first dichroic filter coating 42 on the surface of the glass filter 38 mounted to the glass mounting surfaces 37. The first dichroic filter coating 42 reflects the light wavelengths emitted by the LED and transmits emission light wavelengths emitted from the GBP via the fiber 28.
The second glass filter 40 includes a second dichroic filter coating 44 on the same surface that is mounted to the first glass filter 38. The second dichroic filter coating 44 reflects shorter emission wavelengths representing a signal band and transmits longer wavelengths representing a reference band. A mirror surface 46 is formed on the surface of the second glass filter 40 opposite to the surface mounted to the first glass filter 38. The mirrored surface 46 reflects all wavelengths, but is particularly used to reflect the long wavelengths transmitted by the second dichroic filter coating 44.
Microcontroller 21 is provided at least for operating and controlling the photodiode 22, LED 24 and output display 27. Microcontroller 21 is preferably fully programmable prior to installation within the CGM device to precisely control the operation of the photodiode 22 and data transmitted to the output display 27 via hard-wired connection 23. The microcontroller 21 can also be programmable to manipulate and modify the type of data displayed on the output display 27. For example, the microcontroller 21 can transmit data to the output display 27 relating to a user's current glucose levels, glucose trends, CGM device malfunction notifications, when the output display 27 is illuminated or shut down, and glucose measurement intervals. Additional data processing and transmission can also be provided by the microcontroller 21.
The above defined fiber optic CGM device 10 can be housed within a cover 25, as described previously, or modified to utilize the illustrative OBS covers described below. Additionally, alternative optical CGM devices known in the art can also be modified to include the illustrative OBS covers described below.
An OBS cover encloses and protects the CGM device 10 from environmental conditions that may adversely affect and/or damage the components of the CGM device 10.
In an illustrative embodiment in accordance with the present invention, as shown in
Other illustrative embodiments of output displays can include pop-up type displays, mirrored surface displays, tethered displays having a coiled connection with the CGM device and displays oriented on a side surface of the cover as opposed to a top surface as previously disclosed. Other illustrative embodiments of displays can also include modular displays that are removable from the CGM device cover. Modular displays, for example, can be magnetically secured to the cover or mechanically secured using a snap fit engagement, rail locking mechanism, disconnectable tether or adhesive. For example, the display can include an e-ink paper display with adhesive backing.
In an alternative illustrative embodiment in accordance with the present invention, microcontroller 21 can include a transceiver compatible with a transceiver integral with the e-paper display 77. Thus the microcontroller 21 can transmit data to be displayed by the e-paper display 77. Other alternative transmission systems can also be used to transmit data from the microcontroller to the e-paper display 77. Medical devices currently use radio frequency (RF) wireless communications such as Bluetooth®, Zigbee®, 802.11, or other conventional solutions. Some medical devices even communicate via a line-of-sight using infrared (IR) technology. Wireless communication systems, since they do not require a line of sight, are preferred over IR technology.
Conventional wireless technology is a driving contributor in the cost of medical devices that use their respective technologies. Advantageously, in an alternative illustrative embodiment in accordance with the present invention, the illustrative embodiment shown in
In an illustrative embodiment in accordance with the present invention, a PAN transceiver can be integrated with the microcontroller 21 to establish a personal area network to communicate with the output display 827 via a “near field” electric field that transmits data using the human body as a transport medium. The microcontroller 21 and the output display each need PAN transceivers, respectively, in order to communicate to each other through the body.
In an illustrative embodiment in accordance with the present invention, a PAN communication system ensures that only people in direct contact with a user are capable of detecting the signals propagating across the user's body. Alternatively, in conventional wireless technologies, a transmitted signal can be detected by anyone with a receiver in the respective range of the wireless technology. The necessary transceiver components for realizing the functionality of the illustrative personal area network discussed above, are widely available and relatively low in cost.
In an illustrative embodiment in accordance with the present invention, utilizing the PAN communication system can enable a user to secure the e-paper display 827 on an alternative area on a user's body, separate from the CGM device. E-paper displays 827 can also be relatively inexpensive and thus, disposable after short term use, enabling a user to replace the e-paper displays after exercising, for example.
Although only a few illustrative 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 illustrative embodiments, and various combinations of the illustrative embodiments are possible, 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.
This application claims the benefit under 35 U.S.C. §119 (e) of U.S. Provisional Application No. 61/782,019, filed on Mar. 14, 2013, in the U.S. Patent and Trademark Office, the entire disclosure of which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US14/22613 | 3/10/2014 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61782019 | Mar 2013 | US |
