Handheld diabetes managing device with light pipe for enhanced illumination

A handheld diabetes management device for providing enhanced illumination includes a housing with an access port and a light aperture. The housing further includes a coupling member on an inner surface thereof. Furthermore, the device includes a measurement engine housed within the housing and communicating with the access port for analyzing body fluid disposed on a dosing area of a diabetes test element. Also, the device includes a circuit board communicating with the measurement engine. The device further includes a light source mounted to the circuit board and a light pipe coupled to the housing via the coupling member. The light pipe is disposed adjacent the light source to receive light from the light source travelling in a first direction. The light pipe redirects the light along a second direction to be emitted out of the housing through the light aperture toward the dosing area of the diabetes test element.

FIELD

The present disclosure relates to a handheld diabetes managing device and, more particularly, relates to a handheld diabetes managing device with a light pipe for enhanced illumination of a test element.

BACKGROUND

Diabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body's ability to produce and/or use insulin. There are three main types of diabetes. Type 1 diabetes usually strikes children and young adults, and may be autoimmune, genetic, and/or environmental. Type 2 diabetes accounts for 90-95% of diabetes cases and is linked to obesity and physical inactivity. Gestational diabetes is a form of glucose intolerance diagnosed during pregnancy and usually resolves spontaneously after delivery.

In 2009, according to the World Health Organization, at least 220 million people worldwide suffer from diabetes. In 2005, an estimated 1.1 million people died from diabetes. Its incidence is increasing rapidly, and it is estimated that between 2005 and 2030, the number of deaths from diabetes will double. In the United States, nearly 24 million Americans have diabetes with an estimated 25 percent of seniors age 60 and older being affected. The Centers for Disease Control and Prevention forecast that 1 in 3 Americans born after 2000 will develop diabetes during their lifetime. The National Diabetes Information Clearinghouse estimates that diabetes costs $132 billion in the United States alone every year. Without treatment, diabetes can lead to severe complications such as heart disease, stroke, blindness, kidney failure, amputations, and death related to pneumonia and flu.

Diabetes is managed primarily by controlling the level of glucose in the bloodstream. This level is dynamic and complex, and is affected by multiple factors including the amount and type of food consumed, and the amount of insulin (which mediates transport of glucose across cell membranes) in the blood. Blood glucose levels are also sensitive to exercise, sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to individual patients. The dynamic nature of blood glucose and insulin, and all other factors affecting blood glucose, often require a person with diabetes to forecast blood glucose levels. Therefore, therapy in the form of insulin or oral medications, or both, can be timed to maintain blood glucose levels in an appropriate range.

Management of diabetes is time-consuming for patients because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Diagnostic information, such blood glucose, is typically obtained from a capillary blood sample with a lancing device and is then measured with a handheld blood glucose meter. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Prescribed therapies may include insulin, oral medications, or both. Insulin can be delivered with a syringe, an ambulatory infusion pump, or a combination of both. With insulin therapy, determining the amount of insulin to be injected can require forecasting meal composition of fat, carbohydrates and proteins along with effects of exercise or other physiologic states. The management of lifestyle factors such as body weight, diet, and exercise can significantly influence the type and effectiveness of a therapy.

Management of diabetes involves large amounts of diagnostic data and prescriptive data acquired in a variety of ways: from medical devices, from personal healthcare devices, from patient-recorded logs, from laboratory tests, and from healthcare professional recommendations. Medical devices include patient-owned bG meters, continuous glucose monitors, ambulatory insulin infusion pumps, diabetes analysis software, and diabetes device configuration software. Each of these systems generates and/or manages large amounts of diagnostic and prescriptive data. Personal healthcare devices include weight scales, blood pressure cuffs, exercise machines, thermometers, and weight management software. Patient recorded logs include information relating to meals, exercise and lifestyle. Lab test results include HbAlC, cholesterol, triglycerides, and glucose tolerance. Healthcare professional recommendations include prescriptions, diets, test plans, and other information relating to the patient's treatment.

There are times in which the diabetes patient may wish to perform personal glucose testing in low light conditions. For instance, the patient may want to perform the test in a dark or poorly lit room. Because the test requires a certain amount of precision (e.g., proper placement of a blood droplet on the dosing area of a test strip), it can be difficult to complete the test in such conditions. Thus, there is a need for a handheld diabetes management device for providing enhanced illumination in such situations.

SUMMARY

A handheld diabetes management device for providing enhanced illumination on a dosing area of a diabetes test element is disclosed. The diabetes management device includes a housing with a light aperture and an access port for the diabetes test element. The light aperture is formed on a sidewall of the housing. The light aperture and the access port are separated by a portion of the housing. The housing further includes a coupling member on an inner surface thereof. The device also includes a measurement engine housed within the housing and communicating with the access port for analyzing a body fluid disposed on the dosing area of the diabetes test element. Moreover, the device includes a circuit board housed within the housing and communicating with the measurement engine. Still further, the device includes a light source mounted to the circuit board and a light pipe that is coupled to the housing via the coupling member. The light pipe is disposed adjacent the light source to receive light from the light source travelling in a first direction, and the light pipe redirects the light along a second direction to be emitted out of the housing through the light aperture toward the dosing area of the diabetes test element. The second direction is at a nonzero angle relative to the first direction. Additionally, in some embodiments, the circuit board includes a control processor, and the light source operably communicates with the control processor to provide a visual feedback signal indicating a status of the body fluid analysis. The light pipe transmits the visual feedback signal through the light aperture. Also, in some embodiments, the light pipe includes a first portion and a second elongated portion having a distal end adjacent the light aperture of the housing. The first portion has a first surface facing the light source for receiving light from the light source and a substantially flat reflecting surface at a nonzero angle relative to the first surface. The reflecting surface reflects the light received from the first surface toward the second elongated portion and directs the light out of the housing via the light aperture, such that the light illuminates only the blood dosing area on the test element.

Moreover, a method of providing enhanced illumination on a dosing area of a diabetes test element of a handheld diabetes management device is disclosed. The method includes providing the handheld diabetes management device having a housing. The housing includes a light aperture and an access port for the diabetes test element. The light aperture is formed on a sidewall of the housing, and the light aperture and the access port are separated by a portion of the housing. The housing further includes a coupling member on an inner surface thereof. The handheld diabetes management device also includes a measurement engine housed within the housing and communicating with the access port for analyzing a body fluid disposed on the dosing area of the diabetes test element. The handheld diabetes management device additionally includes a circuit board housed within the housing and communicating with the measurement engine. The handheld diabetes management device further includes a light source mounted to the circuit board, and the handheld diabetes management device also includes a light pipe that is coupled to the housing via the coupling member. The light pipe is disposed adjacent the light source. The method further includes illuminating the light source such that the light pipe receives light from the light source travelling in a first direction. Also, the method includes redirecting the light with the light pipe along a second direction to be emitted out of the housing through the light aperture toward the dosing area of the diabetes test element. The second direction is at a nonzero angle relative to the first direction.

DETAILED DESCRIPTION

Referring initially toFIGS. 1 and 2, an exemplary embodiment of a portable, handheld diabetes management device10is illustrated according to the present teachings. The diabetes management device10can be used for analyzing a body fluid disposed on a dosing area12of a diabetes test element14. For instance, as will be discussed, the test element14can be a disposable glucose test strip of a known type. A droplet of blood can be applied to the dosing area12while the test element14is inserted within the device10, and the device10can analyze the droplet to detect the blood glucose level therein. It will be appreciated, however, that the device10could be used for analyzing any other suitable characteristic of any other body fluid without departing from the scope of the present disclosure.

The device10can include a housing16. The housing16can include a first portion18, an elongate second portion20, and a center portion19. The first, center, and second portions18,19,20can be removably coupled together such that the center portion19is disposed between the first and second portions18,20, to define an interior space therebetween, and to house various components therein, as will be discussed below.

Moreover, the housing16can include and can define an access port22. The access port22can be a slot that is defined in the center portion19. The access port22can removably receive the test element14as will be discussed below.

The housing16can include a light aperture24. In some embodiments, the light aperture24can be a through hole with an ovate shape extending through a sidewall21of the first portion18of the housing16. Furthermore, the light aperture24can be adjacent the access port22; however, the light aperture24can be separated at a distance from the access port22. Specifically, the light aperture24and the access port22can be separated by an intervening portion23of the sidewall21of the first portion18of the housing16such that the light aperture24and access port22are completely separate and distinct from each other.

Referring now toFIGS. 3,4, and7, various internal components that are housed by the housing16will be discussed. For instance, the device10can include a circuit board30. The circuit board can be a printed circuit board with various circuits and circuit components included thereon. For instance, as shown inFIG. 7, a control processor31can be included on the circuit board30for controlling various functions of the device10as will be discussed. Furthermore, a light source32(FIGS. 3,4, and7) can be mounted to the circuit board30. The light source32can be of any suitable type, such as a light emitting diode (LED). The circuit board30, the control processor31, and the light source32can each be housed within the housing16.

The device10can additionally include a measurement engine34(FIGS. 3 and 7). The measurement engine34can be of a known type for analyzing the body fluid applied to the test element14as discussed above. The measurement engine34can be operably mounted to the circuit board30and can communicate with the access port22. As such, when the test element14is inserted within the access port22and the body fluid is applied, the measurement engine34can perform the predetermined analysis. Moreover, the measurement engine34can include associated software and logic (e.g., within the control processor31) for performing and controlling the analysis of the body fluid.

As shown inFIGS. 1,2, and4the device10can include a display40. The display40can be operably connected to the control processor31for displaying various information (e.g., text, graphics, icons, and other objects) relating to the operation of the device10. The display40can be operably supported by the first portion18of the housing16.

Referring now toFIGS. 3-7, the device10will be discussed in additional detail. As shown, the device10can additionally include a light pipe61. The light pipe61can be made out of or include a light transmissive material. For instance, the light pipe61can be made out of or include a rigid, polymeric, light transmissive material. In other embodiments, the light pipe61can be made out of or include a flexible, light transmissive material.

As shown inFIGS. 5-7, the light pipe61can generally include a first portion63and a second portion65. The first and second portions63,65can be integrally connected so as to be monolithic.

The first portion63can be a block with substantially flat surfaces and with chamfered edges. For instance, the first portion63can include a first surface67(FIG. 7) and a second surface69that are opposite and substantially parallel to each other. The first portion63can also include a plurality of side surfaces71a-71dthat each extend substantially perpendicular to the first and second surfaces67,69. The side surfaces71a,71ccan be opposite and substantially parallel to each other. The side surfaces71b,71dcan be opposite and substantially parallel to each other. Moreover, the first portion63can include a reflecting surface73that extends between the second surface69and the side surface71b. The reflecting surface73can be substantially flat and disposed at an acute angle θ1relative to the first surface67. As will be discussed, the angle θ1can be selected so that light transmitted through the first portion63can reflect off of the reflecting surface73toward the second portion65and along an axis XLPof the second portion65.

The second portion65can be substantially elongate, tubular, and can have a substantially straight longitudinal (second) axis XLP. The second portion65can have a rounded (e.g., circular or ovate) or rectangular cross section taken perpendicular to the longitudinal axis XLP. The second portion65can also include a proximal end75, which is connected directly to the side surface71dof the first portion63, and a distal end77that is opposite and spaced apart from the proximal end75. As shown, the second portion65can be tapered between the proximal and distal end75,77. Also, the distal end77can be substantially flat and can be beveled so as to define a plane that is disposed at an acute angle α relative to the longitudinal axis XLP(FIGS. 5 and 6).

It will be appreciated that the first and second portions63,65of the light pipe61can have any other suitable shape. For instance, the first portion63can have one or more rounded (convex or concave) outer surfaces. Moreover, the second portion65can have a non-linear longitudinal axis XLPand/or can any number of flat surfaces in cross section. Furthermore, the distal end77can have convex or concave curvature (e.g., to function as a lens for focusing light transmitted through the light pipe61).

The light pipe61can be coupled to the housing16as shown inFIGS. 3 and 4. For instance, the housing16can include a coupling member78for retaining the light pipe61. In some embodiments, the coupling member78can include a plurality of thin, integrally coupled walls79that extend from an inner surface81of the first portion18of the housing16toward the circuit board30. As shown inFIG. 3, the light pipe61can be received between the walls79to be retained therebetween. The walls79can be shaped and sized so as to define a recess that closely matches the outer periphery of the light pipe61. In some embodiments, the light pipe61can be retained between the walls79by friction, by an interference fit, by adhesives, by a fastener, or in any other manner.

When the light pipe61is mounted to the housing16, the first surface67can be exposed from the walls79of the first portion18of the housing16(FIG. 3). Also, when the light pipe61is mounted, the first surface67can be disposed adjacent the light source32such that the first surface67directly faces the light source32(FIGS. 3 and 7).

Furthermore, when the light pipe61is mounted to the housing16, the distal end77of the second portion65can be disposed adjacent the light aperture24. For instance, the distal end77can be exposed from the housing16via the light aperture24. Also, it will be appreciated that the distal end77can be angled with respect to the longitudinal axis XLPsuch that the distal end77is substantially flush with the area of the housing16surrounding the light aperture24.

During operation, as shown inFIG. 7, light from the light source32can be emitted toward the light pipe61in a first direction D1(e.g., substantially perpendicular to the first surface67. The first surface67can receive the light traveling in the first direction D1and transmit the light toward the reflecting surface73. The light can reflect from the reflecting surface73and be redirected toward a second direction D2. The second direction D2can be at a nonzero angle θ2relative to the first direction D1. For instance, in some embodiments, the angle θ2can be approximately ninety degrees (90°). Once the light is redirected toward the second direction D2, the light can travel along (e.g., substantially parallel to) the longitudinal axis XLPand out of the distal end77of the light pipe61. Thus, the light pipe61can efficiently transmit the light generated by the light source32out of the housing16through the light aperture24. In some embodiments, because the taper of the second portion65of the light pipe61, the transmitted light can be concentrated as it travels through the second portion65.

Also as shown inFIGS. 1 and 2, the light pipe61can be disposed such that the longitudinal axis XLPis substantially directed toward and aligned with the dosing area12of the test element14. As such, the light transmitted from the light pipe61can illuminate the dosing area12as represented by an arrow inFIGS. 1 and 2. In some embodiments, the light pipe61can be focused on the dosing area12to distinguish the dosing area12from other portions of the test element14(e.g., only the dosing area12of the test element14is illuminated by the light pipe61). As such, the user can more easily recognize where to apply a blood droplet for glucose analysis, and proper application of the blood droplet to the dosing area12is more likely.

It will also be appreciated that the device10can provide enhanced illumination efficiently and cost effectively. The light pipe61can be relatively inexpensive. The circuit board30can be manufactured independently with the light source32included thereon before being assembled within the housing16. Then, during assembly of the device10, the light pipe61can be easily mounted to the housing16, and the circuit board30can be housed within the housing16, such that the light pipe61is in its proper position for receiving light from the light source32. The light pipe61is then ready for transmitting light out of the housing16toward the test element14.

In some embodiments, the control processor31can control the light source32such that the light source32provides a visual feedback signal. The visual feedback signal (i.e., the light from the light source32) can be transmitted through the light pipe61.

The visual feedback signal can be of any suitable type. For instance, the light source32can be controlled such that the light emitted by the light source32changes colors (e.g., from blue light to red light, etc.). Also, the light source32can be controlled such that the light is emitted in a predetermined pattern, and the pattern can change to provide feedback. Specifically, the light source32can be illuminated for a predetermined amount of time, and then the light source32can begin blinking, and/or the blinking can speed up or slow down to provide visual feedback.

The feedback signal can be provided for any suitable purpose. For instance, the feedback signal can inform the user that the glucose analysis has been performed successfully, or that there has been an error in performing the glucose analysis. Also, the feedback signal can inform the user that the test element14is faulty and/or is not communicating properly with the measurement engine34. Still further, the feedback signal can inform the user of the results of the analysis (e.g., high glucose level, low glucose level, and/or satisfactory glucose level). It will be appreciated that this visual feedback can be provided in addition to or as an alternative to audible feedback provided by the speaker of the device10and/or by messages or other objects displayed on the display40.

Additionally, as shown schematically inFIG. 7, the device10can include a switch82that selectively turns the light source32on and off. The switch82can be of any suitable type, such as a mechanical switch (e.g., displaceable button, slider, etc.), an electronic switch, and the like. Furthermore, the switch82can automatically turn the light source32on and off in response to other events. For instance, the light source32can turn on automatically when the device10is powered up. Also, the light source32can be operably coupled to an ambient light sensor70, such as a photocell or other similar device, and when ambient light levels are below a predetermined limit, the switch82can automatically illuminate the light source32. In still other embodiments, the light source32can automatically illuminate upon insertion of the test element14into the access port22. The switch82can be designed such that the device10can conserve energy.

Referring now toFIG. 8, a method83of operating the light pipe61of the device10is illustrated according to various exemplary embodiments. As shown, the method83can begin at block85, wherein the switch82is changed from OFF to ON. As discussed above, the switch82can automatically and/or manually turn ON. The method83continues in block87, wherein the light source32begins to illuminate.

Then, in decision block89, it is determined whether the test element14is satisfactory for performing the glucose analysis. For instance, if the test element14is inserted improperly, if the test element14is defective, etc. (decision block89answered negatively), then block91follows. In block91, the control processor31causes the light source32to provide a “test strip fail” feedback signal. As mentioned above, this feedback signal can be a change in color, illumination pattern, etc., informing the user that the test element14needs to be replaced before the analysis can be performed. Subsequently, the method83can restart until a new test element14is replaced and is satisfactory for performing the analysis.

If there is no problem with the test element14(decision block89answered affirmatively), then the glucose analysis can be performed in block93. As mentioned above, the light from the light pipe can illuminate and distinguish the dosing area12of the test element14to help guide the user, even in low ambient light conditions.

Next, in decision block94, it is determined whether the measurement engine34has successfully analyzed the blood on the test element14. If not (decision block94answered negatively), then block95follows, and the control processor31causes the light source32to provide a “test fail” feedback signal. This signal can be different (e.g., in light color, light pattern, etc.) from the signal provided in block91. Subsequently, the method83can restart until the test is performed successfully.

However, if the test is successful (decision block94answered affirmatively), then the control processor31can cause the light source32to provide a “test success” feedback signal in block96. Again, this signal can be different than the other feedback signals discussed above.

Subsequently, in decision block97, it can be determined whether the detected glucose level is within a satisfactory range. If the glucose level is within this range (decision block97answered affirmatively), then a “satisfactory” feedback signal can be output in block98. This feedback signal can be different than each of the feedback signals discussed above in blocks91and95. Moreover, if the detected glucose is either above or below this satisfactory range (decision block97answered negatively) one or more feedback signals can be provided at block99. It will be appreciated that a “high detected glucose level” feedback signal can provided if the detected glucose level is above the satisfactory range, and a “low detected glucose level” feedback signal can be provided if the detected level is below the satisfactory range. The “high” and “low” feedback signals can be different from each other and can be different from each of the other feedback signals of blocks91,95, and98.

Thus, the light pipe61and associated components of the device10can assist the user in performing analyses, especially in low ambient light conditions. Furthermore, the device10can provide various types of feedback to further assist the user.