US20160120452A1 - Blood glucose management - Google Patents

Abstract

This disclosure provides equipment and processes for blood glucose management. Embodiments may comprise a lancet device that includes a base that supports a lancet and a cover. The cover can move controllably from an un-depressed position to a depressed position when a predetermined force is applied. The cover can provide access to the lancet in the depressed position. In another aspect, a biological test kit may include a reusable module and a disposable module. The disposable module may include one or more lancet devices such as that described above to collect a biological sample, one or more strip stations supporting biological strips and a disposable module connector. The reusable module may support measuring equipment to measure a property of the biological sample and a reusable module connector that engages removably with the disposable module connector.

Description

RELATED APPLICATION
• This application claims priority to provisional application U.S. Ser. No. 61/817,172 filed Apr. 29, 2013, the disclosure of which is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELD
• This disclosure relates to technology for collecting biological samples to measure a biological property.
BACKGROUND
• Monitoring blood glucose several times per day is a recommended way for controlling blood glucose levels in patients managing diabetes. Good blood glucose control minimizes loss of life, reduces limb amputations, and enhances quality of life for hundreds of millions of people. It is often recommended by physicians that patients managing diabetes monitor blood glucose levels typically four times a day to mitigate the risks of poor blood glucose control.
• Devices for managing blood glucose typically include a lancing tool. In operation, the tool is opened, and a disposable lancet can be uncovered and inserted into the tool. The user can position the tip against his or her finger and actuate the tool. After that, the blood sample can be transported to a glucose measuring device for analysis. After the lancing event is complete, standard practice is for the user to re-open the tool, and remove and dispose of the lancet. The devices may offer additional features such as a means for the user to enter a depth of insertion of the tool via a dial or a similar input mechanism.
• Blood flow and pain while lancing can be adjusted by the depth of insertion of the lancet. A lancet that is inserted deeper than levels recommended for a specific user can cause a high volume of blood flow and significant pain. By contrast, a lancet that is inserted less deep than recommended levels introduces less pain, but does not draw sufficient quantity of blood for testing blood glucose levels. The lancet can also be replaced with each use to prevent risk of infection. Replacing a lancet with each use can also prevent the lancet from becoming duller with use, and consequently provide less pain while lancing. Pain, expense, and user-unfriendliness are common reasons why diabetes patients may be less likely to monitor their blood glucose levels with diligence.
SUMMARY
• In one aspect, this disclosure teaches an easy-to-use lancet device that produces a sufficient amount of blood without causing undue pain so that patients are more likely to monitor biological properties for disease management. A lancet device can include a base that includes a support surface, a lancet and a cover. The cover can include a peripheral edge along which the cover is connected to the base, a cover region, a lancet aperture, and a peripheral hinge near the peripheral edge. The cover region can cover the lancet when the cover is in an un-depressed position. The lancet can be configured to protrude through the lancet aperture when the cover is in a depressed position. The peripheral hinge can facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force.
• A method of collecting a biological sample may include providing a lancet device such as that discussed above. A predetermined force can be applied on the cover region. The cover can move from an un-depressed position in which the cover region covers the lancet to a depressed position in which the lancet protrudes through the lancet aperture and exposes biological fluid. A quantity of the biological fluid as the biological sample can be collected.
• Certain lancet devices in accordance with embodiments of the present invention may have one or more advantages. For example, the lancet device can be easy to use because it eliminates assembly of multiple pieces. The lancet device can controllably move the skin surface onto and off of a lancet to minimize pain and maximize blood flow. In some instances, different lancet devices can be offered for users with different anatomical features—e.g., one lancet device for users with relatively thick finger skin, and another lancet device for users with relatively thin finger skin. Some embodiments with multiple lancet stations provide visual evidence of which lancet stations have been used and which ones have not yet been used. Some embodiments prevent a lancet station from being used more than once. Some embodiments provide feedback (e.g., audible and/or tactile) as lancing occurs to increase patient comfort. The lancet device can provide increased compliance because of its small size, portability and less pain during use, fewer complications during collection of the biological sample and decreased total cost.
• In another aspect, this disclosure teaches a compact biological test kit for measuring a property of a biological sample that enables re-use of reusable components and disposal of disposable components. The biological test kit can include a reusable module and a disposable module. The disposable module can include one or more lancet devices, such as those described elsewhere herein, and one or more strip stations. The strip station can support one or more biological test strips that can interact with the collected biological sample. The reusable module can support measuring equipment that can measure a property of the biological sample. A reusable module connector and a disposable module connector may removably connect the reusable module and the disposable module. A display monitor can be included with the reusable module to display the measured property.
• Certain biological test kits in accordance with embodiments of the present invention may have one or more advantages. For example, the biological test kit can offer ease of use and portability. In some embodiments, different components can be replaced at different intervals. For example, in embodiments with a reusable module and a disposable module, the disposable module may be replaced with each use (or after a relatively small number of uses), while the reusable module may be replaced at significantly longer intervals. In embodiments in which the disposable module is made up of a lancet station module and a strip station module, the lancet station module and the strip station module can be replaced at different intervals. Multiple lancing events can be performed with the same device, enabling a user to monitor blood glucose levels at a recommended interval. The biological test kit can enable one finger operation. In some embodiments, the entire biological test kit can be roughly the size of a credit card, which can make it more accessible, portable, increase testing compliance and enable a connected real-time management of glucose.
• The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
BRIEF DESCRIPTION OF DRAWINGS
• FIG. 1 is a front elevation view of a lancet device according to embodiments of the invention with the cover in an un-depressed position.
• FIG. 2 is a front elevation view of the lancet device ofFIG. 1 with the cover in a depressed position.
• FIG. 3 is a front elevation view of a lancet device according to embodiments of the invention with the cover in the depressed position.
• FIG. 4(a) is a front elevation view of a lancet device according to embodiments of the invention with the cover in the un-depressed position.
• FIG. 4(b) is a top plan view of a lancet device ofFIG. 4(a).
• FIG. 5(a) is a front elevation view of a lancet device according to embodiments of the invention with the cover in the un-depressed position.
• FIG. 5(b) is a top plan view of the lancet device ofFIG. 5(a).
• FIG. 6 is a graph that shows the force applied to the lancet cover at various stages of use of a lancet device.
• FIG. 7 is a front elevation view of a lancet device according to embodiments of the invention with the cover in the un-depressed position.
• FIG. 8 is a top plan view of a lancet device according to embodiments of the invention.
• FIG. 9(a) is a front elevation view of a lancet device according to embodiments of the invention with the cover in the un-depressed position, and a cap in a capped position.
• FIG. 9(b) is a top plan view of the lancet device ofFIG. 9(a) with the cap in the capped position.
• FIG. 10(a) is a top plan view of a biological test kit according to embodiments of the invention.
• FIG. 10(b) is a front elevation view of the biological test kit ofFIG. 10(a).
• FIG. 11 is an exploded front elevation view of a biological test kit according to embodiments of the invention.
• FIG. 12 is an exploded perspective view of a biological test kit according to embodiments of the invention.
• FIG. 13 is a perspective view of a biological test kit according to embodiments of the invention.
• FIG. 14 is a top plan view of a biological test kit according to embodiments of the invention.
• FIG. 15 is a top plan view of a biological test kit according to embodiments of the invention.
• FIG. 16 is a perspective view of a biological test kit according to embodiments of the invention.
• FIG. 17 is a perspective view of a biological test kit according to embodiments of the invention.
DETAILED DESCRIPTION
• The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing examples of the present invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of ordinary skill in the field of the invention. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives.
• Embodiments of the invention include alancet device100 to collect biological samples. Thelancet device100 can include abase102, alancet104, and acover106. The base102 can include asupport surface108. The base102 can be made of a material that is rigid in comparison to thecover106. The base102 can be made of materials such as a rigid polymer, metal, etc. The base102 can be of any desired size or shape. The base102 may be operably coupled to thecover106. Thesupport surface108 may be a generally planar surface that can house thelancet104. Thesupport surface108 in the illustrated embodiment is an upper surface of thebase102. Thesupport surface108 can be made of similar materials as thebase102 and can be rigid in comparison to thecover106.
• The base102 can support alancet104, which can extend away from thesupport surface108 at an angle of approximately 90°. In many embodiments, thelancet104 can remain stationary with respect to thebase102. Thelancet104 can include a lancingedge150 adapted to make an incision or a puncture on a surface (e.g., skin). Thelancet104 can be made of materials such as stainless steel or similar alloys. The lancingedge150 can be fabricated by grinding or a similar machining technique so that the lancing edge is of a specific geometry and sharpness to pierce a surface such as skin without causing thelancet104 to break. Thelancet104 can be configured to pierce the skin of a user to collect a quantity of blood sample.
• Thecover106 can be operably coupled to thebase102 of thelancet device100. Thecover106 can include aperipheral edge110 along which the cover is connected to the base. In some embodiments, thecover106 can be coupled to the base102 at a selected location near theperipheral edge110. In some embodiments, thecover106 can be coupled to thebase102 along the entireperipheral edge110. Thecover106 can be made of a polymeric material that has a sufficiently large elasticity to move a specific distance when a specified force is applied on the cover. The polymeric or metallic material may be selected to include favorable elastic properties that allow the cover to move in a controlled manner. Instead of or in addition to engineered polymers, a spring, foam, cam and helix device, or other suitable mechanism can be included between thecover106 and the base102 that facilitates controlled movement of the cover when a predetermined depression force is applied.
• Thecover106 can include acover region120 configured to cover thelancet104 when thecover106 is in an un-depressed position. Thecover region120 has a hemispherical or domed shape in the un-depressed position in the illustrated embodiment. The height of the cover region above the base is indicated as “h”, and the diameter of the cover region in the un-depressed position is indicated as “d”. It can be appreciated that thecover region120 can have any desired shape in the un-depressed position such as a cuboidal cover region with rounded edges or similar shapes. In some embodiments, thecover106 can include a diving board configuration. In some embodiments, thecover region120 can comprise a cover region geometry that includes cover region edges122 and124. The cover region edges122 and124 define a cover region wall thickness “a”. Thecover region120 can move a specific distance when a predetermined depression force is applied on thecover region120. The predetermined depression force can cause thecover region120 to move in a controlled manner from the un-depressed position, to a depressed position, shown inFIGS. 2 and 3. When the cover region is in the depressed position, thecover region120 provides access to thelancet104.
• In some embodiments, thecover106 can include aperipheral hinge116 near theperipheral edge110 as shown inFIG. 4(a). In some embodiments, theperipheral hinge116 can include peripheral hinge geometry. The peripheral hinge geometry can comprise a variety of configurations. For example, in some embodiments, peripheral hinge edges112,114 can define a peripheral hinge wall thickness “b” as shown inFIG. 4(a). In some embodiments, the peripheral hinge geometry can includeperipheral hinge edge112 orperipheral hinge edge114 but not both. In some embodiments, the peripheral hinge geometry can include rounded or angular hinges. Peripheral hinge edges112,114 can include or can be replaced by curved, angled or box-shaped notches or projections near theperipheral edge110. For instance, the notches can be angled as V or H-shaped notches with a projection of complementary shape. The notches or projections can act as a hinge joint and can resemble a knee or an elbow joint. It can be appreciated that other hinge shapes that introduce a similar effect can be included without any loss of functionality. Theperipheral hinge116 facilitates the controlled movement of thecover106 from the un-depressed position to the depressed position upon application of a predetermined depression force.
• In many embodiments, the peripheral hinge geometry can differ from the cover region geometry. For example, the cover region thickness “a” can be different from the peripheral hinge thickness “b”. In some embodiments, the peripheral hinge wall thickness “b” is between approximately 25% and approximately 50% of the cover region wall thickness “a”. In some embodiments, the peripheral hinge wall thickness “b” is less than half of the cover region wall thickness “a”. In some embodiments, the peripheral hinge wall thickness “b” is between ⅔ and ¾ the cover region wall thickness “a”. In some embodiments, the peripheral hinge wall thickness “b” is less than ⅔ the cover region wall thickness “a”. In some embodiments, the peripheral hinge wall thickness “b” is less than ¾ the cover region wall thickness “a”. The cover region thickness “a” and the peripheral wall hinge thickness “b” can be varied during fabrication of the device.
• Thelancet device100 can be configured such that thecover106 moves from the un-depressed position to the depressed position upon application of a predetermined force that a typical user would be capable of applying. In some embodiments, the predetermined depression force can be between approximately 500 and approximately 1500 grams. In some embodiments the predetermined depression force can be between approximately 700 grams and approximately 2000 grams. In some embodiments, the predetermined depression force can be between approximately 800 grams and approximately 1200 grams. In some embodiments, the predetermined depression force can be between approximately 700 grams and approximately 800 grams. In some embodiments, the predetermined depression force can be between approximately 800 grams and approximately 900 grams. In some embodiments, the predetermined depression force can be between approximately 900 grams and approximately 1000 grams. In some embodiments, the predetermined depression force can be between approximately 1000 grams and approximately 1100 grams. In some embodiments, the predetermined depression force can be between approximately 1100 grams and approximately 1200 grams. In some embodiments, the predetermined depression force can be between approximately 1200 grams and approximately 1300 grams. In some embodiments, the predetermined depression force can be between approximately 1300 grams and approximately 1400 grams. In some embodiments, the predetermined depression force can be between approximately 1400 grams and approximately 1500 grams. In some embodiments, the predetermined depression force can be between approximately 1500 grams and approximately 1600 grams. In some embodiments, the predetermined depression force can be between approximately 1600 grams and approximately 1700 grams. In some embodiments, the predetermined depression force can be between approximately 1700 grams and approximately 1800 grams. In some embodiments, the predetermined depression force can be between approximately 1800 grams and approximately 1900 grams. In some embodiments, the predetermined depression force can be between approximately 1900 grams and approximately 2000 grams. In some embodiments, the predetermined depression force can be greater than 2000 grams. The distance traveled by thecover region120 between the un-depressed (shown as dashed lines inFIGS. 2-3) and the depressed position, is indicated by a depression depth “f” inFIGS. 2-3. The depression depth “f” can be between approximately 0.2 millimeters and approximately 4 millimeters when the predetermined force is applied. Different configurations with different required depression forces may be offered for different kinds of users. The depression depth can be adjusted by including a design of thecover region120 with a diameter “e” and a height “g” that are different from the illustrated diameter “d” and the illustrated height “h”.
• In some embodiments, thecover106 can include alancet aperture132 through which thelancet104 is configured to protrude when thecover106 is in a depressed position. Thelancet aperture132 is illustrated as a circular opening inFIG. 5(b), but can also be of other shapes. The diameter or the opening size of thelancet aperture132 is at least equal to the thickness of the lancet as shown inFIG. 5(a) so that thelancet104 protrudes out of thelancet aperture132 when thecover106 is in the depressed position. Thelancet aperture132 may be introduced in thecover region120 by cutting or tearing thecover region120 appropriately to the required geometry and dimensions of thelancet aperture132. Thelancet104 can protrude through thelancet aperture132 to a protrusion height “c” when thecover106 is in the depressed position as shown inFIGS. 2-3. In some embodiments, the protrusion height “c” of thelancet104 can be between approximately 0.3 millimeters and approximately 1.2 millimeters. The protrusion height “c” can be selected so that optimal quantity of biological sample is collected. For example, if the lancet device is used for collecting blood from a user by lancing the user's finger skin, an appropriate protrusion height “c” can ensure optimal quantity of blood is drawn from the user's finger and at the same time minimizing pain in the user due to lancing. Anatomical features such as thickness of the finger skin, pain tolerance, and blood flow through a user's blood vessels can be considered by a user in deciding on a suitable protrusion height of the lancet. A user can, for instance, apply less force on thecover region120 of thelancet device100, causing the protrusion height “c” to be lower, than in the case if the user where to apply more force on thecover region120.
• In some embodiments, thecover106 can be configured to provide an auditory and/or tactile response as thecover106 moves from the un-depressed position to the depressed position upon application of the predetermined depression force. When thelancet device100 is used to collect a biological sample such as a blood sample from a user by lancing the user's skin, the auditory and/or tactile response can facilitate lower pain perception by a user. In some embodiments, thecover106 is engineered from a material such that the material provides an auditory response when it moves from the un-depressed position to the depressed position. In some such embodiments, the auditory response can be a pleasing sound (e.g., a snapping sound) when the force due to the user's finger pressure on thecover106 equals the predetermined depression force. The pleasing sound can cause the user to perceive lower pain due to lancing. In some such embodiments, the pleasing sound can be accompanied by a tactile response (e.g., a sensation that thecover106 has snapped past a threshold point), which can cause lower pain perception. In some embodiments, the tactile response can be provided with little or no auditory response. In some embodiments, thelancet104 does not vibrate during lancing leading to lower pain perception.
• In some embodiments, thecover106 can be configured to provide a force response. This force response is illustrated inFIG. 6. The force response facilitates movement of thecover106 from the depressed position back to the un-depressed position upon removal of the predetermined depression force. In some embodiments, thecover106 is made of materials that can be engineered to provide the force response. The force response can be used to facilitate lower pain perception by a user. As shown inFIG. 6, thecover106 can be configured such that when the force due to finger pressure equals the predetermined depression force (FIG. 6, Point2), the design features of thecover106 can move from resisting the depression force to acceleration in downward movement until it reaches a designed stop (FIG. 6, Point3). After the skin has been lanced due to this movement, the depression force can lift from the cover (FIG. 6, Point4). The design features of thecover region120 can create a spring-like response accelerating thecover106 back up which pushes upward and lifting the skin off the lancet104 (FIG. 6, Point5). Finally the skin is lifted from thecover106 so that no force is applied (FIG. 6, Point6).
• In some embodiments, thecover106 can include arelease aperture134 to release trapped air that might impede controlled movement of thecover106. Therelease aperture134 can be located near theperipheral edge110 of thecover106. Therelease aperture134 is illustrated as a circular opening inFIG. 5(b). It can be appreciated that therelease aperture134 can be of other geometrical shapes without loss of functionality. Therelease aperture134 can be of a size on the order of the size of thelancet aperture132. Any trapped air near theperipheral edge110 of thecover106 can resist movement of thecover region120 toward the depressed position when the predetermined force is applied. Therelease aperture134 allows the trapped air near the peripheral edge110 (the air cannot escape through thelancet aperture132 because thelancet aperture132 is essentially sealed by the user's skin) to escape through therelease aperture134 outwardly from theperipheral edge110, thereby facilitating controlled movement of thecover region120 between the un-depressed and depressed positions.
• In some embodiments, thecover106 can include aspike162 extending toward thebase102. The spike can be of a material similar to thelancet104, or other suitable material. In this embodiment, thelancet device100 can include acavity164 on thebase102 under thecover106. Thecavity164 may include acavity wall166 that holds pressurized gas. As thecover106 moves from the un-depressed position to the depressed position, thespike162 can moves toward thecavity164, eventually piercing thecavity wall166. Thecavity164 can release pressurized gas upon being pierced by thespike162. The released gas can exert pressure on thecover106 to push thecover106 from the depressed position back to the un-depressed position. The pressurized gas combination can be used in addition to thecover106 with engineered materials capable of providing a force response.
• In some embodiments, the base102 can include avisual indicator170 that shows if the cover has been moved from the un-depressed position to the depressed position as shown inFIG. 8. The base102 can be made of a material that can be configured to provide a pattern or a color change. The color or pattern change can occur when the applied force on thecover region120, such as due to finger pressure when lancing, exceeds the predetermined depression force. Thevisual indicator170 can include a color or pattern changing surface made of materials such as pressure sensitive coating or films operably coupled to thebase102. Thevisual indicator170 facilitates a user in identifying whether a lancet device was previously used and allow for single use of a lancet device. Visual indicators other than those shown may be incorporated into lancet devices in various embodiments of the present invention.
• In some embodiments, the base102 can include astop180 under thecover106. Thestop180 can be configured to dictate a distance by which thelancet104 is configured to protrude through the lancet aperture when thecover106 is in the depressed position. The size of thestop180 can be determined during manufacture based on the depth of insertion of thelancet104. Thestop180 is illustrated as a rectangular projection inFIG. 3. It can be appreciated that thestop180 can have any desired shape, such as a hemispherical projection or other shapes. Thestop180 can be fabricated from materials similar to thebase102. Thestop180 can be included with the base102 as a single component during fabrication.
• In some embodiments, the lancet device can include acap140 as shown inFIGS. 9(a)-9(b). Thecap140 can operably couple with the base102 by ahinge connection142 as shown in the illustrated embodiment, or by similar mechanical fasteners. Thecap140 can be made of materials similar to that of thebase102. Thecap140 can be positioned from a capped position to an uncapped position. In the capped position, thecap140 is in close proximity to thebase102, and encloses thecover106, thereby preventing access to thelancet104. In the uncapped position, thecap140 facilitates access to thelancet104. Thecap140 can be configured to act as a sterile barrier when in the capped position to isolate thelancet104 from contaminants.
• In use, alancet device100 such as those discussed elsewhere herein can be used for collecting blood from a user for monitoring glucose. In some embodiments, thelancet device100 can be used for collecting similar biological samples. A user can apply a force on thecover region120. The force applied by the user can be due to finger pressure. The force applied on thecover region120 may increase as indicated by the force ramp during stages1-2 inFIG. 6. If the force applied by the user is equal to or greater than a predetermined force, thecover106 can move from an un-depressed position in which the cover region covers the lancet to a depressed position during stage2-3 inFIG. 6. Thelancet104 protrudes through thelancet aperture132 in the depressed position and exposes biological fluid. A quantity of the biological fluid as the biological sample can be collected during stages3-4 inFIG. 6.
• When the user stops applying force on thecover region120, thecover region120 exerts a pushing force opposite to the force applied by the user. The pushing force can be as a result of tension in thecover region120 due to its material elasticity and/or by one or more mechanical tensioning elements included in the cover region as discussed elsewhere herein. The pushing force from thecover region120 gradually increases as shown by the force ramp during stages4-5 inFIG. 6. Whenstage5 is reached, thecover region120 has moved from the depressed position back to the un-depressed position. The user can then remove the finger from the lancet device and proceed to provide the biological sample for the desired purpose.
• Some embodiments of the present invention involve abiological test kit200. Thebiological test kit200 can include areusable module210 and adisposable module220. In some embodiments, thedisposable module220 andreusable module210 can be fabricated as a single, integral module and cannot be modularly connected to and disconnected from one another. In many embodiments, thedisposable module220 can be removably connected with thereusable module210. Thebiological test kit200 is illustrated as having a rectangular shape inFIG. 7, but can have any desired shape such as square or oval without loss of functionality. In the illustrated embodiment, the biological test kit has a length “x”, a width “y” and a thickness “z”. The thickness “z” of thebiological test kit200 can be substantially less than the length “x” or the width “y”. Thebiological test kit200 can be fabricated by molding a rigid polymer material such as plastic or by machining a similar material. In some embodiments, the thickness “z” can be less than or equal to ½ inch. In some embodiments, the thickness “z” can be less than or equal to 0.35 inches. In some embodiments, the thickness “z” can be less than or equal to 0.2 inches.
• In some embodiments, thereusable module210 can include areusable module housing212, measuringequipment214, and areusable module connector216. Thereusable module housing212 can include a generally planar support surface to support the measuringequipment214. In some embodiments, thereusable module housing212 may include a second support surface. The second support surface can house thereusable module connector216. The planar support surface and the second support surface can be any of the surfaces of thereusable module210. In the illustrated embodiment, the planar support surface supporting themeasuring equipment214 is the top surface of thereusable module housing212. The support surface that houses thereusable module connector216 is a lateral surface of thereusable module housing212. Any of the top, bottom, front, back or lateral surfaces can house the measuringequipment214 andreusable module connector216 without loss of functionality of thebiological test kit200.
• The measuringequipment214 and thereusable module210 connector can be supported by thereusable module housing212. The measuringequipment214 can be configured to measure a property of a biological sample. The measuringequipment214 can include a sensor that can measure a specific property of the biological sample by electro-chemical means or other methods known in the arts. The measuringequipment214 can, for instance, be configured to measure blood glucose level. For example, a chemical reaction can occur between a specific quantity of blood glucose, and an enzyme or a reagent that generates an electric current at an electrode. The measuringequipment214 can then be configured to sense the electric current and calibrated to correlate a specific value of an electric current to a blood glucose level.
• In some embodiments, thereusable module210 can include adisplay monitor218 supported by thereusable module housing212 and configured to display the measured property. The display monitor218 can be a LCD panel or LED or similar display device that can display the measured property and/or other relevant information. The display monitor218 can be supported by thereusable module housing212 by any of the known methods, including microfabrication techniques. In the illustrated embodiment, thedisplay monitor218 is a rectangular panel of diagonal length “w.” It may be appreciated that the display monitor218 can be of any desired size or shape to display the measured property (e.g., as alphanumeric characters). Thedisplay monitor218, for instance, can display blood glucose level as a numerical value in milligrams per deciliter, when thebiological test kit200 collects blood from users for diabetes management.
• Thedisposable module220 can include adisposable module housing222, at least one lancet station, at least one strip station, and adisposable module connector226. Thedisposable module housing222 can be made of a rigid polymer material such as plastic. Thedisposable module housing222 may include a support surface to house at least one lancet station and one strip station, and can be adapted to provide support to multiple lancet and strip stations or other components. In some embodiments, thedisposable module housing222 can include a second support surface that house thedisposable module connector226.
• Thefirst lancet station240 can be supported by and is stationary relative to thedisposable module housing222. Thefirst lancet station240 is illustrated in the embodiment as comprising a circular station, though other configurations are contemplated as within the scope of this disclosure. Thefirst lancet station240 can include a device such as thelancet device100 described elsewhere herein. Thefirst lancet station240 can comprise a cover supported by thedisposable module housing222. The cover can be fabricated from a polymeric material with sufficient elasticity to depress to a specific height upon application of a predetermined force. The cover can include an aperture that provides access to a lancet. The lancet can be supported by the disposable module housing. Thefirst lancet station240 can include any of the embodiments of thelancet device100. Thefirst lancet station240 can facilitate the generation of a first biological sample. The first biological sample, for instance, can be a small quantity of blood for monitoring blood glucose.
• Thefirst strip station250 can be supported by thedisposable module housing222. Thefirst strip station250 can include a firstbiological strip260 configured to receive the first biological sample. The firstbiological strip260 can be rectangular with a thickness much smaller than length and width. The firstbiological strip260 can be fabricated from a sheet of polymeric material with coatings to generate a signal that can be input to themeasuring equipment214 when exposed to the first biological sample. The firstbiological strip260 can include a coating of an enzyme or a reagent that can electro-chemically react with the first biological sample. Thefirst strip station250 can be configured to provide the first biological sample to themeasuring equipment214 for measurement of the property.
• Thedisposable module connector226 can be supported by thedisposable module housing222 and can be modularly connectible to thereusable module connector216. In some embodiments, thedisposable module connector226 and thereusable module connector216 can together comprise an interlocking fastener. The disposable andreusable module connectors226 and216 can be mechanical connectors such as clips, latches, hooks and loops or similar fasteners. The disposable andreusable module connectors226 and216 can be adhesive connectors.
• In some embodiments, thedisposable module housing222 can include first and secondsub-module housing280,290 as shown inFIG. 12. The first and secondsub-module housing280,290 can be fabricated from similar materials as thedisposable module220. The firstsub-module housing280 can be configured to support thefirst lancet station240. The firstsub-module housing280 can include a firstsub-module connector282. In the illustrated embodiment, the firstsub-module housing280 supports thefirst lancet station240 on a generally planar top surface of the firstsub-module housing280. The firstsub-module connector282 is supported on a generally planar lateral surface of the firstsub-module housing280. Any of the top, bottom, front, back or lateral surfaces of the firstsub-module housing280 can support the firstsub-module connector282.
• The secondsub-module housing290 can be configured to support thefirst strip station250. The secondsub-module housing290 supports thefirst strip station250 on a generally planar top surface. The secondsub-module housing290 can include a secondsub-module connector292 that is modularly connectible to the firstsub-module connector282. The secondsub-module connector292 is shown supported on a generally planar lateral surface of the secondsub-module housing290. Any of the top, bottom, front, back or lateral surfaces of the secondsub-module housing290 can support the secondsub-module connector292. The first and secondsub-module connectors282 and292 can removably connect by mechanical means such as clips, latches, hook and loop fasteners. An adhesive film can be applied on the first and secondsub-module connectors282 and292. It can be appreciated that either of the first sub-module280 or second sub-module290 can be fabricated together with thereusable module210 to form a non-separable module. In such an embodiment, the non-separable module can be removably connected with the remaining sub-module by connectors similar to those discussed elsewhere herein. Many variations are contemplated depending on the desired application.
• In some embodiments, thebiological test kit200 can have an overall thickness “z” of approximately 12.7 millimeters. In some embodiments, thebiological test kit200 can have a thickness “z” of less than one centimeter and approximately 5 millimeters. In some embodiments, thebiological test kit200 can have a length of less than 10 centimeters and approximately 8 centimeters. In some embodiments, thebiological test kit200 can have a width of approximately 5 centimeters. Thebiological test kit200 can be fabricated from polymers such as sheets of plastic by machining the sheets to specific dimensions and providing the reusable anddisposable module housings212,222 with means to couple to afirst lancet station240, afirst strip station250,measurement equipment214, display monitor218 and other components as discussed above. Thebiological test kit200 can be fabricated by techniques such as molding.
• In some embodiments, the disposable module can include asecond lancet station242 and asecond strip station252. Thesecond lancet station242 and thesecond strip station252 can be similar in size and shape to thefirst lancet station240 and thefirst strip station250. Thesecond lancet station242 and thesecond strip station252 can be supported by thedisposable module housing222. Thesecond lancet station242 can be configured to remain stationary relative to thedisposable module housing222. Thesecond lancet station242 can be configured to facilitate generation of a second biological sample. The second biological sample can be similar to the first biological sample. The second biological sample can be substantially distinguishable from the first biological sample in composition.
• Thesecond strip station252 can include a secondbiological strip262 configured to receive the second biological sample. The secondbiological strip262 can be of a size and shape to be supported by thesecond strip station252. The secondbiological strip262 can be fabricated from a sheet of polymeric material with coatings to generate a signal that can be input to themeasuring equipment214 when exposed to the second biological sample. The secondbiological strip262 can include a coating of an enzyme or a reagent that can electro-chemically react with the second biological sample. Thesecond strip station252 can be configured to provide the second biological sample to themeasuring equipment214 for measurement of the property.
• It should be understood that, while embodiments discussed elsewhere herein include one or two lancet stations and one or two strip stations, some biological test kits can have other numbers of lancet stations and/or strip stations. For example, some embodiments include four lancet stations (e.g., thebiological test kit200 ofFIG. 11). Some embodiments include different numbers of lancet stations, such as three, five, six, and so on. Some embodiments include different numbers of strip stations, such as three, five, six, and so on. In many embodiments, the number of lancet stations is equal to the number of strip stations. Such embodiments can facilitate one use of a lancet station for each strip station. In some embodiments, the number of lancet stations and/or strip stations on a disposable module can be tied to the number of times per day a category of patients must measure a biological sample. For example, if a significant percentage of diabetic patients are encouraged to check their blood glucose levels five times per day, a biological test kit can be offered that includes five lancet stations and five strip stations so that the patients can use one disposable module per day.
• In some embodiments, the measuringequipment214 of thebiological test kit200 can include a correlation mechanism configured to identify a measured biological sample as having originated from thefirst strip station250 or the second strip station252 (or other strip stations). The measuringequipment214 can be configured to provide whether the measured biological sample originated from thefirst strip station250 or thesecond strip station252 to the display monitor218 for display in a manner known in the art, such as integrated circuit board connections, or similar means. In the embodiment shown inFIGS. 7-10, thebiological test kit200 includes four lancet stations and four strip stations. It can be appreciated that more than two lancet and strip stations can be included in thebiological test kit200. The measuringequipment214 can be adapted to include a correlation mechanism that can identify a measured biological sample as having originated from one of the many strip stations.
• In some embodiments, thereusable module210 can include a wireless transmitter supported by thereusable module housing212. The wireless transmitter can be configured to transmit a signal representative of the measured property to a separate device for display. The wireless transmitter can be a Bluetooth transmitter that can interface with a mobile device that is adapted with a Bluetooth receiver, or any similar transmission device. The mobile device may be a cell phone or tablet devices that can receive signals transmitted wirelessly, and store the measured property.
• In some embodiments, thereusable module210 can include a mobile device case connector supported by thereusable module housing212. The mobile device case connector can be configured to detachably connect thereusable module210 to a mobile device case. The mobile device case connector can be supported by any of the top, bottom, front, back or lateral surfaces of thereusable module housing212. The mobile device case connector can be a clip, latch, hook-and-loop fastener or similar mechanism that can removably connect with a mobile device case. The mobile device case connector can be an adhesive coating or film. Thebiological test kit200 can be coupled to a mobile device case such as a cell phone case or a tablet device case for ease of carrying.
• In some embodiments, thedisposable module220 can include an insulindelivery device connector234 supported by thedisposable module housing222 as shown inFIG. 13. The insulindelivery device connector234 can be configured to detachably connect thedisposable module220 to aninsulin delivery device230. The insulindelivery device connector234 can be supported by any of the top, bottom, front, back or lateral surfaces of the disposable module housing. The insulindelivery device connector234 can be a clip, latch, hook-and-loop fastener or similar mechanism that can removably connect with aninsulin delivery device230. The insulindelivery device connector234 can be an adhesive coating or film. Theinsulin delivery device230 can be an insulin storage container with asyringe232 for delivering insulin in users who monitor and manage blood glucose levels. Theinsulin delivery device230 can be removably connected to thereusable module210 by the insulindelivery device connector234. It should be understood that thedisposable module220 andreusable module210 need not be removably connected and be fabricated as a single module. In such an embodiment, theinsulin delivery device230 can be removably connected with the single module by the insulindelivery device connector234. It should also be understood that theinsulin delivery device230 can be supported by thereusable module210 in some embodiments.
• FIG. 14 shows abiological test kit300 according to some embodiments. Thebiological test kit300 can include areusable module310 and adisposable module320. In some embodiments, thedisposable module320 andreusable module310 can be fabricated as a single module. In many embodiments, thedisposable module320 and thereusable module310 can be fabricated as separate modules removably connectable to one another. Thereusable module310 can include areusable module housing312, measuringequipment314 and a reusable module connector316 (not shown). Thedisposable module320 can include adisposable module housing322, afirst lancet station340, afirst strip station350, and a disposable module connector326 (not shown). Thedisposable module320 can be removably connected to thereusable module310 by the disposable module connector326 and the reusable module connector316. Thefirst strip station350 can include aslot354 in the disposable module housing and astrip container356 positioned in theslot354. Theslot354 and thestrip container356 can be fabricated from materials such as plastic. The size of the slot and thestrip container356 are such that thestrip container356 can store a first biological strip360 (or other biological strips) and thestrip container356 can slide in and out of theslot354. Thestrip container356 can be configured to slide into and out of theslot354 between a closed position and an open position. Thestrip container356 can be adapted to provide access to the firstbiological strip360 when in the open position, as shown inFIG. 13. Thestrip container356 can be configured to house a second biological strip362 (or other biological strips). It can be appreciated theslot354 and thestrip container356 can be positioned on thereusable module310. In some embodiments of thebiological test kit300, the reusable and disposable modules may not form a removable connection and are fabricated as a non-separable or integral module. In such an embodiment, theslot354 and thestrip container356 can be positioned on the non-separable module and configured similar to means discussed above.
• FIGS. 15-17 illustrate abiological test kit400 according to some embodiments. Thebiological test kit400 can include areusable module410 and adisposable module420. Thedisposable module420 andreusable module410 can be fabricated as a single module. Thereusable module410 can include areusable module housing412, measuringequipment414 and a reusable module connector416. Thedisposable module420 can include adisposable module housing422, afirst lancet station440, afirst strip station452, and a disposable module connector426 (not shown). Thedisposable module420 can be removably connected to thereusable module410 by the disposable module connector426 and the reusable module connector416. Thefirst strip station452 can include arecess472 defined in thedisposable module housing422 and astrip station cover474. Therecess472 shown as a shaded portion inFIG. 14 can be configured to hold a firstbiological strip462. Therecess472 can be cut or machined on thedisposable module housing422 to accommodate the firstbiological strip462. Asecond strip station450 can include a secondbiological strip460 positioned in a recess similar to therecess472 and covered by thestrip station cover474. Thestrip station cover474 and the secondbiological strip460 are indicated by dashed lines inFIG. 14. It should be understood that such an embodiment can include any number of strip stations, as discussed elsewhere herein.
• Thestrip station cover474 can be removably connected to thedisposable module housing422. The strip station cover can be configured to cover therecess472 and prevent access to the firstbiological strip462 when in a covered position. Thestrip station cover474 can be configured to permit access to the firstbiological strip462 when in an uncovered position. Thestrip station cover474 can be removably connected to thedisposable module housing422 by mechanical fasteners or adhesives. Thestrip station cover474 can be a film containing an adhesive to removably connect to thedisposable module housing422. Thestrip station cover474 can be peeled to remove the adhesive connection between thestrip station cover474 and thedisposable module housing422. In the illustrated embodiment shown inFIG. 15,strip station cover474 prevents access to the firstbiological strip462 in a covered position. A secondbiological strip460 can be accessed when a corresponding strip station cover is in an uncovered position.FIGS. 16 and 17 show thestrip station cover474 according to some embodiments. In the illustrated embodiments, thestrip station cover474 includes a groove that is configured to engage with thedisposable module housing422 by a friction fit. In the illustrated embodiments inFIGS. 15-17, the first andsecond strip stations450 and452 are located on thedisposable module420. It can be appreciated that thebiological test kit400 can be fabricated as a single component without two modules that can be removably connected (E.g.: the disposable and the reusable module forming a single module). In such an embodiment, thestrip station cover474 forms a friction fit with the single module.
• In use, a biological test kit such as those discussed elsewhere herein can be used for managing blood glucose by periodically testing blood glucose levels. The biological test kit can include a lancet device such as those discussed elsewhere herein. The lancet device can be used to collect a quantity of a biological sample, such as blood from the user. A biological test strip such as glucose strips supported by a strip station can interact with the collected biological sample by electro-chemical or other means. The lancet device and the strip station can be supported by a disposable module. Measuring equipment supported on a reusable module can measure a biological property, such as blood glucose level in milligrams per deciliter. A display monitor supported on the reusable module can display the measured blood glucose level.
• A user can repeat this procedure with a second lancet station and a second strip station included on the disposable module of the biological kit. Once the user has used all the lancet stations and all the strip stations on the disposable module of the biological kit, the user can disengage the disposable module by removing the connection between the disposable module connector and the reusable module connector. The reusable module can be retained by the user and another disposable module comprising lancet devices and strip stations can be removably connected to the reusable module using techniques discussed elsewhere herein.
• Various examples of the invention have been described. Although the present invention has been described in considerable detail with reference to certain disclosed embodiments, the embodiments are presented for purposes of illustration and not limitation. Other embodiments incorporating the invention are possible. One skilled in the art will appreciate that various changes, adaptations, and modifications may be made without departing from the spirit of the invention and the scope of the appended claims.

Claims (2)

1. A lancet device comprising:

(a) a base that includes a support surface;

(b) a lancet supported by the base and extending away from the support surface at an angle of approximately 90°;

(c) a cover that includes (i) a peripheral edge along which the cover is connected to the base, (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position, the cover region having a cover region geometry, (iii) a lancet aperture through which the lancet is configured to protrude when the cover is in a depressed position, and (iv) a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force.

2-26. (canceled)

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