US20200278338A1 - Diagnostic medical device and methods of use thereof - Google Patents

Abstract

A medical device to test bodily fluid, the device comprising a light emitting source, the light emitting source arranged to emit light inside the medical device; a test strip port, the test strip port comprising a test strip port receptacle to receive a test strip; and the light emitting source and the test strip port arranged such that, when the light emitting source emits light, at least a portion of the light emitted from the light emitting source is redirected inside the medical device to provide redirected light inside the medical device, and at least a portion of the redirected light lights the test strip port from inside the medical device in a manner than the redirected light is visible outside the test strip port.

Description

RELATED APPLICATIONS
• This application is a divisional of pending U.S. Non-Provisional patent application Ser. No. 15/009,979, filed Jan. 29, 2016, the entire contents of which is incorporated by reference herein by reference in its entirety.
TECHNICAL FIELD
• The present disclosure relates to handheld electronic devices, and more particularly to diagnostic (fluid testing) medical devices.
BACKGROUND INFORMATION
• Medical devices include diagnostic devices to determine a medical condition of a patient or other person. Diagnostic medical devices include fluid testing medical devices, which may be used to test bodily fluids of a person. One such diagnostic medical device is a blood glucose meter, which is used as a diagnostic device to determine blood glucose levels of a person having diabetes mellitus.
• Blood glucose meters use a test strip that receives a blood sample from a person when placed thereon. The blood glucose meter includes a test strip port to receive the test strip. The test strip includes electrical contacts that are electrically coupled to the meter when the test strip is inserted into the meter. The meter may then determine a blood glucose level by measuring electrical current passed through the electrical contacts of the strip, and provide a determination of the glucose concentration level in the person's blood with an algorithm.
• As may be appreciated, a person may have to measure their blood glucose level at various times during a day. As such, the blood glucose meter typically remains with the person. Unfortunately, the meter may be stored or otherwise placed in environments where solid (e.g. dirt) and liquid (e.g. water) debris may enter the test strip port, which may damage the blood glucose meter from proper operation.
• It also may be appreciated that a person may have to measure their blood glucose level at night. As such, if surrounding artificial light is not present, it may become difficult to properly place the test strip in the test strip port.
SUMMARY
• The present disclosure provides medical devices, particularly diagnostic (fluid testing) medical devices which make use of a test strip to test bodily fluid of a body, particularly that of a person or animal. More particularly, the diagnostic medical devices may be blood glucose meters, which are used as diagnostic devices to a determine blood glucose level of a person or animal having diabetes mellitus.
• The diagnostic (fluid testing) medical devices disclosed herein include a test strip port having a test strip port receptacle to receive the test strip. The test strip port may be lighted to assist in proper placement of a test strip in the test strip port at night or otherwise low light conditions. The test strip port may also be protected from egress of solid particulate as well as liquid.
• In certain embodiments, a medical device to test bodily fluid may comprise a light emitting source, the light emitting source arranged to emit light inside the medical device; a test strip port, the test strip port having a test strip port receptacle to receive a test strip; and the light emitting source and the test strip port arranged such that, when the light emitting source emits light, at least a portion of the light emitted from the light emitting source is redirected inside the medical device to provide redirected light inside the medical device, and at least a portion of the redirected light lights the test strip port from inside the medical device in a manner than the redirected light is visible outside the test strip port.
• In certain embodiments, the test strip port may include a light guide comprising a light guide annular ring defining a light guide annular ring opening, the light guide annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the light guide annular ring opening; and the light guide is arranged to receive light emitted from the light emitting source and redirect at least a portion of the light from the light emitting source towards the light guide annular ring to light the light guide annular ring from inside the medical device. In certain embodiments, the light guide is translucent or transparent.
• In certain embodiments, the light guide may be formed from a thermoplastic polymer composition. In certain embodiments, the thermoplastic polymer composition may include at least one translucent polymer and/or at least one transparent polymer. In certain embodiments, the thermoplastic polymer composition may include at least one of polycarbonate, polyurethane, polystyrene and polymethyl methacrylate.
• In certain embodiments, the medical device to test bodily fluid may further comprise an outer cover which is detachable from the medical device and reattachable to the medical device, and the test strip port may be fastened to the outer cover. In certain embodiments, the light guide of the test strip port may be fastened to the outer cover.
• In certain embodiments, the test strip port may include a test strip connector, the test strip connector including electrical contacts which electrically couple with the test strip, and the light guide may form a pocket with the outer cover which receives a portion of the test strip connector.
• In certain embodiments, the light emitting source may be arranged such that, when a test strip is received into the test strip port receptacle, the light from the light emitting source is aimed substantially transverse to a longitudinal axis of the test strip and towards the test strip.
• In certain embodiments, the light guide may be arranged to redirect at least a portion of the light from the light emitting source approximately ninety degrees towards the light guide annular ring such that the redirected light travels substantially parallel to the longitudinal axis of the test strip.
• In certain embodiments, the test strip port may further comprise a seal which inhibits ingress of at least one of solid particulate and water into the test strip port receptacle.
• In certain embodiments, the seal may provide an ingress protection rating of IP22 when tested in accordance with International Standard IEC 60529:1989+A1:1999(E) of the International Electrotechnical Commission.
• In certain embodiments, the seal may include a closure flap which extends over at least a portion of the test strip port receptacle.
• In certain embodiments, the test strip port may include a light guide comprising a light guide annular ring defining a light guide annular ring opening, the light guide annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the light guide annular ring opening, and the light guide may be arranged to receive light emitted from the light emitting source and redirect at least a portion of the light from the light emitting source towards the light guide annular ring to light the light guide annular ring from inside the medical device, the seal closure flap may extend over at least a portion of the light guide annular ring opening to inhibit the ingress of at least one of the solid particulate and the water into the test strip port receptacle.
• In certain embodiments, the seal may comprise a seal annular ring defining a seal annular ring opening, the seal annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the seal annular ring opening.
• In certain embodiments, the seal may be formed from an elastomeric polymer composition. The elastomeric polymer composition may include at least one translucent polymer and/or at least one transparent polymer, and the elastomeric polymer composition may include at least one elastomer. The at least one elastomer may be a (silicone) rubber. In certain embodiments, the seal may be translucent or transparent.
• The present disclosure also provides a handheld electronic device comprising a main body, a cover engageable to the main body by engagement of a snap-fit connection and disengageable from the main body by disengagement of the snap-fit connection, the snap-fit connection engageable by translational motion of the cover relative to the main body, and the snap-fit connection disengageable by rotational motion of the cover relative to the main body, while the snap-fit connection is not disengageable by translational motion of the cover relative to the main body.
• In certain embodiments, the main body comprises a center axis and at least two resilient cantilevered arms, and the at least two resilient cantilevered arms are arranged to move towards and away from the center axis.
• In certain embodiments, the at least two resilient cantilevered arms are arranged to move towards each other during engagement of the snap-fit connection.
• In certain embodiments, the at least two resilient cantilevered arms each include at least one engagement tab, the cover includes at least two engagement tab receptacles, and each of the at least two engagement tab receptacles is configured to receive one of the engagement tabs.
BRIEF DESCRIPTION OF THE DRAWINGS
• The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and better understood by reference to the following description of embodiments described herein taken in conjunction with the accompanying drawings, wherein:
• FIG. 1 is a front (plan) view of a medical device according to the present disclosure;
• FIG. 2 is a top end view of the medical device ofFIG. 1;
• FIG. 3 is a partial perspective view of the medical device ofFIG. 1;
• FIG. 4A is a rear (plan) view of the medical device ofFIG. 1 with a test module;
• FIG. 4B is a rear (plan) view of the medical device ofFIG. 1 without the test module;
• FIG. 5 is an inner perspective view of the test module;
• FIG. 6A is a side view of the medical device ofFIG. 1 before the test module is attached to the main body of the medical device;
• FIG. 6B is cross-sectional end view of the medical device ofFIG. 6A taken alongline6B-6B ofFIG. 6A;
• FIG. 6C is an enlarged cross-sectional end view of the portion of the medical device withincircle6C ofFIG. 6B;
• FIG. 7A is a side view of the medical device ofFIG. 1 while the test module is being attached to the main body of the medical device;
• FIG. 7B is cross-sectional end view of the medical device ofFIG. 7A taken alongline7B-7B ofFIG. 7A;
• FIG. 7C is an enlarged cross-sectional view of the portion of the medical device withincircle7C ofFIG. 7B;
• FIG. 7D is partial cross-sectional plan view of the medical device ofFIG. 7A taken alongline7D-7D ofFIG. 7A;
• FIG. 8A is a side view of the medical device ofFIG. 1 after the test module is attached to the main body of the medical device;
• FIG. 8B is cross-sectional end view of the medical device ofFIG. 8A taken alongline8B-8B ofFIG. 8A;
• FIG. 8C is an enlarged cross-sectional view of the portion of the medical device withincircle8C ofFIG. 8B;
• FIG. 8D is partial cross-sectional plan view of the medical device ofFIG. 8A taken alongline8D-8D ofFIG. 8A;
• FIG. 9A is a side view of the medical device ofFIG. 1 during removal of the test module where the test module is rotated at an angle A of 5 degrees relative to the x-y plane and longitudinal axis LA;
• FIG. 9B is a side view of the medical device ofFIG. 1 during removal of the test module where the test module is rotated at an angle A of 15 degrees relative to the x-y plane and longitudinal axis LA;
• FIG. 10 is an inner view of a cover of the test module of the medical device ofFIG. 1 before assembly of the electronic components with the cover;
• FIG. 11 an inner view of the test module of the medical device ofFIG. 1 after assembly of the electronic components with the cover;
• FIG. 12 is a close-up inner view of the test module ofFIG. 11 without the electronic components;
• FIG. 13 is close-up inner view of the test module ofFIG. 11;
• FIG. 14 a perspective view of a light guide of the test module of the medical device ofFIG. 1;
• FIG. 15 is a perspective view of the light guide and a seal of the test module of the medical device ofFIG. 1;
• FIG. 16 is a cross-sectional side view of the test module of the medical device ofFIG. 5 taken along line16-16 ofFIG. 13 without the cover; and
• FIG. 17 is a cross-sectional side view of the medical device ofFIG. 1 taken along line17-17 ofFIG. 1 with a test strip inserted in the test strip port.
DETAILED DESCRIPTION
• It may be appreciated that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention(s) herein may be capable of other embodiments and of being practiced or being carried out in various ways. Also, it may be appreciated that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting as such may be understood by one of skill in the art.
• By way of brief introduction, the present disclosure discloses medical devices, particularly diagnostic (fluid testing) medical devices which make use of a test strip to test bodily fluid of a person or animal. More particularly, the diagnostic medical devices may be blood glucose meters, which are used as diagnostic devices to a determine blood glucose level of a person or animal having diabetes mellitus.
• Referring now to the drawings, particularlyFIGS. 1-5, there is shown a handheld, electronic, diagnostic (fluid testing)medical device10, and more particularly a blood glucose meter. As shown,device10 includes atest strip port32. As best shown inFIGS. 2-3,test strip port32 comprises atest strip receptacle34 to receive adisposable test strip2 therein (see e.g.FIG. 17). More particularlytest strip2 may be a blood glucose test strip. Whilemedical device10 may be referred to in particular embodiments herein as a blood glucose meter, the disclosure should not be understood as being limited to blood glucose meters.
• Blood glucose meter10 includes comprises amain body12. Among other features,main body12 includes a visualoutput display panel14 to display test results.
• Main body12 also includes anenclosure16 which contains thevisual display14.Enclosure16 comprises afront housing18 and arear housing20 which provide a housing to protect at least a portion of the main body electronic components contained in theblood glucose meter10.
• Blood glucose meter10 also includes a removable/detachable and replaceable/reattachable test module30 which includes thetest strip port32. However, the configuration of thetest module30 andmain body12, and more particularly the following assembly/latching mechanism, may inhibit disassembly/unlatching of thetest module30 by a patient, or other individual/person unauthorized for such removal.
• As shown,test module30 may be mechanically fastened to the main body, particularly by twomechanical fasteners22, which may particularly comprise threaded fasteners such as screws.
• Test module30 comprises atest module cover36 to whichelectronic components40 of thetest module30 are fastened, which includes at least one printed circuit board.
• Referring now toFIGS. 6A-8D, thetest module30 may be assembled to themain body12 with a snap-fit connection by being pressed onto themain body12, particularly with an assembly force F being applied to thetest module30 transverse to a Cartesian plane CP (parallel with the z-axis) of themain body12, which may be understood as the x-y reference plane of the Cartesian x, y, z coordinate system (shown inFIGS. 1 and 2).
• More particularly, in addition to the use of separatemechanical fasteners22,test module30 may also be detachably fastened tomain body12 by a positive mechanical engagement which provides the snap-fit connection. As shown inFIGS. 6A-6C, the positive mechanical engagement may be created by two opposingengagement tabs44 provided on the lateral outer sides of resilient cantileveredarms46 of themain body12, which enter two opposing mating engagement tab receptacles48, respectively, formed in thecover36.
• During assembly, as shown inFIGS. 7A-7D, and more particularlyFIG. 7C, eachengagement tab44 of resilient cantileveredarms46 bears against an inwardly directed opposingengagement tab49 oftest module cover36, respectively forcing eachcantilevered arm46 to move inwards from an initial first position (as shown inFIG. 6C) and deflect with elastic deformation towards one another, which inward deflection is biased by the resiliency thereof. More particularly, eachcantilevered arm46 may rotate about the z-axis in the x-y (Cartesian) plane, with each arm moving predominately in the x direction towards the center of themain body12.
• As shown inFIG. 7C, once eachcantilevered arm46 moves to a second position at which thearm46 deflects inwards a sufficient distance to enable theengagement tabs44 of eacharm46 to clear theopposing engagement tab49 oftest module cover36, and enter engagement tab receptacles48 provided by thetest module cover36, the resiliency of each cantileveredarms46 may then return eachcantilevered arm46 to its first position as shown inFIGS. 8A-8D, and more particularlyFIG. 8C. More particularly, as eachengagement tab44 enters theengagement tab receptacle48 formed in thetest module cover36, the cantileveredarms46 rotate outwards to form the positive mechanical engagement and complete assembly of the overlap snap fit connection.
• Once assembled, transversely extendingperipheral lip43 and ribs37 (FIG. 5) of thetest module30 may positively mechanically engage within a mating transverseperipheral groove45 and rib receptacles39 (transverse to the x-y plane) of themain body12, respectively, to inhibit thetest module30 from sliding off themain body12 along the x-y plane.
• As set forth above, thetest module30 may be initially secured bymechanical fasteners22. However, themechanical fasteners22 may be removed in the field. To thwart disassembly oftest module30 in the absence ofmechanical fasteners22, as also explained above, thetest module30 is first configured to inhibit being slid off themain body12 along the x-y plane. Furthermore, the positive mechanical engagement formed between themain body12 andtest module30 inhibits thetest module30 from being separated transverse to the x-y plane.
• Referring now toFIGS. 9A-9B, in order to disassembletest module30 from themain body12 after the removal ofmechanical fasteners22, thetest module30 may be rotated relative to themain body12. More particularly, thetest module30 may be rotated about an axis transverse to the longitudinal axis LA (e.g. x-axis), which is shown further as a center axis, particularly by lifting laterally extendingmedial edge47 oftest module cover36. In such manner, amedial region41 of thetest module30 may be lifted relative to aperipheral region42 of thetest module30. As themedial region41 of thetest module30 is raised, such may cause eachengagement tabs44 on the lateral outer sides of resilient cantileveredarms46 of themain body12 to once again bear against inwardly directed opposingengagement tab49 oftest module cover36, respectively forcing eachcantilevered arm46 to cantilever inwards, forcing eachcantilevered arm46 to deflect inwards with elastic deformation towards one another, which is biased by the resiliency thereof. Once each cantileveredarm46 deflects inwards a sufficient distance to enable theengagement tabs44 to clearengagement tabs49 and exit engagement tab receptacles48 formed incover36, thetest module30 is passively released and the resiliency of each cantileveredarms46 may then return eachcantilevered arm46 to its first position.
• The configuration of thetest module30 andmain body12, and more particularly the foregoing disassembly mechanism, is configured to passively release thetest module30 when thetest module30 is rotated at an angle A of 5-30 degrees relative to the longitudinal axis LA, and more particularly 10-20 degrees relative to the longitudinal axis LA.
• Now, to further thwart undesirable disassembly of thetest module30, as themedial region41 of thetest module30 is lifted relative to aperipheral region42 of thetest module30, the force required to lift the medial region increases (due to increasing resistance of the positive mechanical engagement) as the angle A increases, until thetest module30 is passively released. In light of such, to a person untrained in disassembly of thetest module30, the increase in force to lift themedial region41 may give an impression that thetest module30 may break if lifted in a manner as set forth above, causing attempted disassembly to be abandoned. However, no portion of themain body12 ortest module30 is intended to break.
• From the foregoing description, amedical device10 is provided in which thetest module cover36 is engageable to themain body12 by engagement of a snap-fit connection and disengageable from themain body12 by disengagement of the snap-fit connection. More particularly, the snap-fit connection is engageable by translational motion of the test module cover36 relative to themain body12, and disengageable by rotational motion of the test module cover36 relative to themain body12, while not being disengageable by translational motion of the test module cover36 relative to themain body12. It should be understood thatmedical device10 may be any electronic device, and not be limited to a medical device.
• Furthermore, it should be understood that themain body12 comprises a center axis, such as the longitudinal axis LA, and the cantileveredarms46 are arranged to move towards and away from the center axis, particularly during engagement/disengagement of the snap-fit connection. More particularly, the cantileveredarms46 are arranged to move towards each other, as well as away from each other during engagement/disengagement of the snap-fit connection.
• Turning to operation of thetest module30, andFIGS. 10-17, the entrance to thetest strip receptacle34 is provided by a narrow slot (through hole)38 formed in thetest module cover36. Referring particularly toFIG. 16, thetest strip receptacle34 thereafter extends throughseal50,light guide52 and into atest strip connector54, which electrically couplestest strip2 to theelectronic components40 of thetest module30. Once atest strip2 is inserted withintest strip receptacle34 and properly seated therein, and blood is placed thereon, theblood glucose meter10 may then determine a blood glucose level by measuring electrical current passed through the electrical contacts of thetest strip2 in a known manner, and provide a determination of the glucose concentration level in the blood.
• In order to light thetest strip port32 to assist in proper placement of atest strip2 in thetest strip port32 at night or otherwise low light conditions,light guide52 receives light from alight emitting source24 of theblood glucose meter10 which may be located in the main body12 (seeFIG. 17).Light emitting source24 may comprise at least one light emitting diode (InGaN, water clear lens, viewing angle 120°/20.5) which emits white (visible) light in a wavelength of 390-700 nm (or frequency range of 430-770 THz) and a luminous intensity in a range of 200-900 millicandela, and more particularly 400-700 millicandela, when tested in accordance with CIE127-2007 (I_F=5 mA) standards.
• As best shown byFIGS. 14-15,light guide52 includes aU-shaped section60 and an oblongannular ring section62 defining a slot (through hole)64. As shown,U-shaped section60 includes ahorizontal center span66 disposed between two spaced apartvertical stanchions72 which are transverse to thecenter span66.Center span66 includes a centrally disposed cylindricallight receiving post68 having a planar, circularlight receiving surface70 arranged to receive light from thelight emitting source24 of themain body12.
• As shown byFIG. 12-13, thevertical stanchions72 of theU-shaped section60 are fastened to the inner surface oftest module cover36, particularly by adhesive. Thecenter span66 and thestanchions72 form arecess pocket74 which contains anend lip portion56 oftest strip connector54. Together, thecenter span66 of theU-shaped section60 of thelight guide52 and theend lip portion56 oftest strip connector54 define a portion of thetest strip receptacle34, including aslot76 therebetween to accommodatetest strip2 as it extends throughslot38 in thetest module cover36,slot64 in the oblongannular ring section62 of thelight guide52 and completely intotest strip connector54.
• In order to transmit light,light guide52 is formed of a light transmissive polymer composition. As used herein, a light transmissive polymer composition may be characterized as providing integral transmission of at least 60% of incident light in the visible spectrum (about 400-700 nm wavelength), and more preferably at least 70% of incident light in the visible spectrum, and even more preferably, at least 80% or 90% of incident light in the visible spectrum. A light transmissive polymer composition may be optically translucent and, more preferably, an optically transparent. The light transmissive polymer composition may be a thermoplastic polymer composition which is suitable for injection molding. The thermoplastic light transmissive polymer composition may comprise at least one transparent polymer such as polycarbonate, polyurethane, polystyrene and polymethyl methacrylate.
• With the foregoing arrangement, thelight emitting source24 is arranged to emit light inside themedical device10. In addition, thelight emitting source24 and thetest strip port32 are arranged such that, when thelight emitting source24 emits light, at least a portion of the light emitted from thelight emitting source24 is redirected inside themedical device10 to provide redirected light inside themedical device10, and at least a portion of the redirected light lights thetest strip port32 from inside themedical device10.
• More particularly, thelight guide52 is arranged to receive light emitted from thelight emitting source24 and redirect at least a portion of the light from thelight emitting source24 towards the light guideannular ring62 to light the light guideannular ring62 from inside themedical device10.
• More particularly, thelight emitting source24 is arranged such that, when atest strip2 is received into the teststrip port receptacle34, the light from thelight emitting source24 is aimed substantially transverse to a longitudinal axis of thetest strip2 and towards thetest strip2. Thelight guide52 is arranged to redirect at least a portion of the light from thelight emitting source24 approximately ninety degrees towards the light guideannular ring62 such that the redirected light travels substantially parallel to the longitudinal axis of thetest strip2.
• When light is emitted from light emittingsource24 intolight receiving post68 oflight guide52,light guide52 is configured such that the light from the oblongannular ring section62 of thelight guide52 will be emitted in the form of annular ring around thetest strip2, which may be oriented substantially parallel with the longitudinal axis of thetest strip2 upon insertion of thetest strip2 into thetest strip port32.
• Whileblood glucose meter10 may be configured to automatically light thetest strip port32 in response to receiving atest strip2 therein,blood glucose meter10 may also be configured to lighttest strip port32 in response to manual push button activation, such as by pushing activation (on/off)button26 as shown inFIGS. 2 and 3. To save power, theblood glucose meter10 may include an ambientlight sensor28 to disable such functionally when ambient light is above a predetermined level.
• While visible (white) light may be preferred to light thetest strip2, light emittingsource24 may be configured to emit various individual colors of the electromagnetic spectrum. For example, thelight emitting source24 may emit red (620-700 nm), yellow (570-590 nm) or green (495-565 nm) light as an indicator of port status (e.g. green is ready for use, yellow is not ready for use and red is to report an error), or the light may blink to remind the patient to test their blood glucose level.
• Test strip port32 may also be protected from egress of solid particulate as well as liquid byseal50. Similar tolight guide52,seal50 includes an oblongannular ring section92 defining a slot (through hole)94. Oblongannular ring section92 is disposed on anintermediate section80 of thelight guide52 disposed between ashoulder82 of theU-shaped section60, and the oblongannular ring section62. Oblongannular ring section92 forms a seal against theshoulder82 of theU-shaped section60 and the inner surface oftest module cover36 surroundingslot38 formed in thetest module cover36. In this manner, external debris is inhibited from enteringtest strip port32 betweenseal50 andtest module cover36.
• Oblongannular ring section92 further includes an elastically deformable U-shapedentrance door flap96 which is in a closed position whentest strip2 is not within thetest strip port32, and which may rest against (i.e. be in connect with the inner side of oblongannular ring section62 oflight guide52. At this time, theentrance door flap96 is in a closed position which substantially closesslot64 of thelight guide52 to inhibit external debris from enteringtest strip port32, and more particularly inhibits debris from entering thetest strip receptacle34 beyondslot64 in the oblongannular ring section62 of thelight guide52.
• Whentest strip2 is inserted withintest strip port32, elastically deformableentrance door flap96 deforms elastically inward, particularly along ahinge portion98, upon being contacted bytest strip2 to openslot64 in the oblongannular ring section62 of thelight guide52 and correspondinglyopen slot94 in the oblongannular ring section92 ofseal50.Entrance door flap96 may rotate at an angle θ in a range of, for example of 60 to 90 degrees.
• Seal50 may be particularly formed of an elastomeric polymer composition. As used herein, an elastomeric polymer composition may be characterized as a composition that has an elongation at 23° C. of at least 100%, and which, after being stretched to twice its original length and being held at such for one minute, may recover in a range of 50% to 100% within one minute after release from the stress. More particularly, the elastomeric polymer composition may recover in a range of 75% to 100% within one minute after release from the stress, and even more particularly recover in a range of 90% to 100% within one minute after release from the stress. The elastomeric polymer composition may be a composition with a Tg below room temperature and which is at most, 50% crystalline (i.e., the material contains an amorphous phase of 50% or greater, up to 100% amorphous phase). The elastomeric polymer composition may comprise a thermoplastic polymer composition which is suitable for injection molding. The elastomeric polymer composition may comprise at least one thermoplastic elastomer, such as styrene block polymers, such as styrene block copolymers (e.g. styrene-butadiene copolymer) and styrene block terpolymers (e.g. styrene-butadiene-styrene terpolymer, styrene-ethylene/butylene-styrene terpolymer, styrene-ethylene/propylene-styrene terpolymer); polyolefin blends (e.g. polypropylene and ethylene-propylene-diene monomer rubber, polypropylene and nitrile rubber, ethylene-propylene rubber); elastomeric alloys such as melt-processable rubbers and thermoplastic vulcanizates; polyolefins; polyurethanes; polyesters; and rubbers such as natural rubber, neoprene rubber, acrylic rubber, butadiene rubber, butyl rubber, ethylene-propylene rubber, ethylene propylene diene monomer rubber, fluorocarbon rubber, isoprene rubber, nitrile rubber, polyurethane rubber and silicone rubber.
• Theseal50 may also be formed of a rigid polymer composition, particularly where thehinge portion98 may be configured as a living hinge. Example materials include polypropylene or acrylonitrile-butadiene-styrene.
• Furthermore, the elastomeric polymer composition ofseal50 may also be a light transmissive polymer composition. As used herein, a light transmissive polymer composition may be characterized as providing integral transmission of at least 60% of incident light in the visible spectrum (about 400-700 nm wavelength), and more preferably at least 70% of incident light in the visible spectrum, and even more preferably, at least 80% or 90% of incident light in the visible spectrum. A light transmissive polymer composition may be optically translucent and, more preferably, an optically transparent.
• With the foregoing constriction, seal50 of thetest strip port32 ofblood glucose meter10 may passively seal to inhibit external debris, liquid (e.g. water) and solid (e.g. dirt), from entering the test strip port. More particularly,test strip port32 may be sealed to meet IP22 fluid and particulate ingress requirements for home use medical products per International Electrotechnical Commission International Standard IEC 60529:1989+A1:1999(E), which is incorporated herein by reference.
• The IP Code, International Protection Marking or IEC standard 60529, sometimes interpreted as Ingress Protection Marking or IP Rating, classifies and rates the degree of protection provided against intrusion (body parts such as hands and fingers), dust, accidental contact, and water by mechanical casings and electrical enclosures. It is published by the International Electrotechnical Commission (IEC) as noted above.
• For example, an electrical socket rated IP22 is protected against insertion of fingers and will not be damaged or become unsafe during a specified test in which it is exposed to vertically or nearly vertically dripping water. The first digit indicates the level of protection that the enclosure provides against ingress of solid foreign objects. A level of 2 corresponds to the enclosure providing protection against ingress of objects greater than 12.5 mm, which is effective against fingers or similar objects. The second digit indicates the level of protection that the enclosure provides against harmful ingress of water. A level of 2 corresponds to the enclosure providing protection against ingress of dripping water when tilted up to 15 degrees (i.e. vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15° from its normal position). The enclosure is tested for 10 minutes, with a water equivalent to 3 mm rainfall per minute.
• Furthermore, when light is emitted from light emittingsource24 intolight receiving post68 oflight guide52,light guide52 is configured such that light will be transmitted and directed into the oblongannular ring section92 ofseal50 such that light from the oblongannular ring section92 of theseal50 will be emitted in the form of annular ring around thetest strip2.
• Moreover, when light is emitted from light emittingsource24 intolight receiving post68 oflight guide52,light guide52 is configured such that light will be transmitted and directed into thedoor flap96 ofseal50 such that light will be emitted from thedoor flap96 of theseal50.
• In addition to the foregoing,medical device10 may also provide protection against electrostatic discharge (ESD). For example,medical device10 may comply with International Standard IEC 60601-2-24:2012, as tested per IEC 61000-4-2: 2008, incorporated by reference, (Electromagnetic compatibility (EMC)—Part 4: Testing and measurement techniques—Section 2: Electrostatic Discharge Immunity Test) at a level of +/−8 kV contact discharge and +/−15 Kv air discharge.
• While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.
LIST OF REFERENCE CHARACTERS
• • 2 test strip
  • 10 medical device
  • 12 main body
  • 14 visual display
  • 16 main body enclosure
  • 18 front housing
  • 20 rear housing
  • 22 mechanical fasteners
  • 24 light emitting source
  • 26 light emitting source activation (on/off) push button
  • 28 ambient light sensor
  • 30 test module
  • 32 test strip port
  • 34 test strip receptacle
  • 36 test module cover
  • 37 ribs
  • 38 test module cover slot
  • 39 rib receptacles
  • 40 test module electronic components
  • 41 medial region
  • 42 peripheral region
  • 43 transverse lip
  • 44 engagement tab
  • 45 transverse groove
  • 46 cantilevered arm
  • 47 medial edge
  • 48 engagement tab receptacle
  • 49 engagement tab
  • 50 seal
  • 52 light guide
  • 54 test strip connector
  • 56 test strip connector end portion
  • 60 U-shaped section
  • 62 oblong annular ring section
  • 64 oblong annular ring section slot
  • 66 center span
  • 68 light receiving post
  • 70 light receiving surface
  • 72 stanchion
  • 74 recess pocket
  • 76 slot
  • 80 intermediate section
  • 82 shoulder
  • 92 oblong annular ring section
  • 94 oblong annular ring section slot
  • 96 entrance door flap
  • 98 hinge portion
  • A angle

Claims (20)

What is claimed is:

1. A device, comprising:

a main body; and

a test module detachably coupled to the main body, the test module including a cover engageable to the main body by engagement of a snap-fit connection and disengageable from the main body by disengagement of the snap-fit connection, wherein the snap-fit connection is engageable by translational motion of the cover relative to the main body, and wherein the snap-fit connection is disengageable by rotational motion of the cover relative to the main body.

2. The device ofclaim 1, wherein the snap-fit connection is not disengageable by translational motion of the cover relative to the main body.

3. The device ofclaim 1, wherein the main body comprises a center axis and at least two resilient cantilevered arms, and wherein the at least two resilient cantilevered arms are arranged to move towards and away from the center axis.

4. The device ofclaim 3, wherein the at least two resilient cantilevered arms are arranged to move towards each other during engagement of the snap-fit connection.

5. The device ofclaim 3, wherein the at least two resilient cantilevered arms each include at least one engagement tab, wherein the cover includes at least two engagement tab receptacles, and wherein each of the at least two engagement tab receptacles is configured to receive one of the engagement tabs.

6. A device, comprising:

a main body; and

a test module detachably coupled to the main body, wherein the test module comprises a cover including a receptacle operable to receive a biasable arm of the main body for coupling the main body and the cover together, and wherein the cover includes a rib engageable within a rib receptacle of the main body to restrict motion of the cover relative to the main body.

7. The device ofclaim 6, the cover further comprising an engagement tab operable to engage a corresponding engagement tab of the biasable arm to restrict translational motion of the cover away from the main body.

8. The device ofclaim 7, the engagement tab of the cover comprising a sloped surface operable to bias the biasable arm relative to a center axis of the main body as the engagement tab and the corresponding engagement tab engage one another.

9. The device ofclaim 7, the corresponding engagement tab of the biasable arm comprising a sloped surface operable to bias the biasable arm relative to a center axis of the main body as the engagement tab and the corresponding engagement tab engage one another.

10. The device ofclaim 9, the main body further comprising a second biasable arm, wherein the biasable arm and the second biasable arm are operable to move relative to the center axis of the main body when the main body and the cover are coupled together.

11. The device ofclaim 6, the cover further comprising a test strip receptacle.

12. The device ofclaim 6, wherein the rib extends from an inner surface of the cover.

13. The device ofclaim 6, the test module further comprising one or more electronic components and a test strip connector coupled to the cover, the test strip connector operable to receive a test strip.

14. A handheld electronic device, comprising:

a main body; and

a test module detachably coupled to the main body, wherein the test module comprises a cover including an engagement tab operable to engage a biasable arm of the main body for securing the main body and the cover together, and wherein the cover includes a rib engageable within a rib receptacle of the main body to restrict motion of the cover and the main body relative to one another.

15. The handheld electronic device ofclaim 14, the biasable arm comprising a corresponding engagement tab, wherein the engagement tab and the corresponding engagement tab are operable to engage one another to restrict translational motion of the cover relative to the main body.

16. The handheld electronic device ofclaim 15, the corresponding engagement tab comprising a sloped surface operable to bias the biasable arm relative to a center axis of the main body as the engagement tab and the corresponding engagement tab engage one another.

17. The handheld electronic device ofclaim 16, the main body further comprising a second biasable arm, wherein the biasable arm and the second biasable arm are operable to move relative to the center axis of the main body when the main body and the cover are coupled together.

18. The handheld electronic device ofclaim 14, the cover further comprising a test strip receptacle.

19. The handheld electronic device ofclaim 14, the test module further comprising one or more electronic components coupled to the cover.

20. The handheld electronic device ofclaim 14, wherein the rib extends from an inner surface of the cover.

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