HK1118002B - Dynamic integrated lancing test strip with sterility cover - Google Patents

Description

Dynamic integrated lancing test strip with sterile sheath

Background

The present invention relates generally to body fluid sampling devices and more particularly, but not exclusively, to integrated lancing test strips with a lancet contained within a sterile sheet.

The acquisition and testing of bodily fluids is useful for many purposes, and is becoming increasingly important in medical diagnosis and treatment of, for example, diabetes, or other applications. In the medical field, it is desirable that non-professional operators perform routine, rapid and repeatable tests outside of a laboratory setting, and that results be obtained quickly, with the resulting test information being readable. Various body fluids may be tested, and for some specific applications, testing may involve testing of blood and/or body tissue fluids, among others. Testing at home is difficult for many patients, particularly those with limited hand dexterity, such as the elderly or diabetics. For example, diabetics can experience numbness or tremor in their extremities, such as their hands, which makes self-testing difficult because they cannot accurately position the test strip to collect the blood sample. In addition, wounds of diabetics also recover relatively slowly, and therefore, it is desirable that the depth of the incision be small.

An integrated lancing test strip has recently been developed in which a lancet is integrated into the test strip to form a self-contained disposable unit. Such an integrated unit simplifies the collection and testing of bodily fluid samples to some extent, however, there are many problems to be solved in order to commercially implement such a unit. One of the problems is how to maintain the sterility of the lancet so as to minimize the risk of infection. In practice, conventional plastic or syringe-type caps are not accessible by integrated lancing test strips for several reasons, particularly for those designs in which the lancet is movable relative to the rest of the test strip. For a typical syringe-type cap, the cap can be removed from the lancet by pulling or twisting the cap to close the lancet. However, this is difficult, if not practically impossible, if it is desired to remove the cap from the lancet without destroying or destroying the integrated device. Moreover, it is difficult to automatically remove the cap. One trend is to make the lancet smaller and thinner to create smaller trauma or smaller invasive incisions, thereby promoting healing of the incision while making self-monitoring less painful. However, due to its thin nature, the lancet is more prone to bending or other damage, especially when the protective cap is removed. Also, the pulling or twisting action can damage the test strip when the cap is removed, such as damaging delicate electrodes in an electrochemical-type test strip, or even cause separation of the lancet from the test strip.

Integrated devices have been proposed in which the lancet is enclosed in a sterile plastic body or a molded plastic plug that can close the end of the lancet cavity. In lancing, the lancet pierces the body and extends from the body and the needle pierces the body tissue. Such a design is suitable for an automated system, since the lancet can function without having to remove the protective cap. However, this type of design is less suitable for the clip type, drum type, dark box type, insert box type, considering its characteristics of bulkiness and rigidity. The encapsulating plastic gives rise to a rather large outer shape which does not allow a tight fitting of a plurality of integrated devices into one sealing device. The device itself is too rigid for a roll-to-roll cassette type design due to certain rigid properties of the closure material. In addition, the plastic injection molding process required to manufacture such integrated devices can make the devices rather expensive and difficult to assemble. This design also limits the extent to which the lancet can be made small because the lancet must be sufficiently rigid to puncture the seal.

Another integrated disposable design has also been proposed in which the entire unit is sealed into a protective envelope. However, this design requires the entire disposable unit to be sterilized at the same time, which causes a number of difficulties. Unfortunately, lancet sterilization techniques, such as radiation, can adversely affect the chemistry of the test strip. Therefore, the accuracy of the test strip is severely hampered if not compensated for. In order to compensate for such variations occurring during sterilization, samples from multiple sterilization batches need to be taken to calculate adjustments or calibration values for a single batch. Prior to use, lot calibration values need to be entered into the meter (meter), either manually or automatically, to compensate for lot variations. In addition, certain lancet sterilization techniques are also less practical if the lancet is combined with a test strip because such techniques tend to damage or even destroy components on the test strip. There is also the potential for undesirable cross-contamination between the lancet and the test strip if they are sealed in the same protective envelope. For example, components of the test strip, such as chemical components, biological components, adhesives, or the like, can intrude into the enclosure onto the lancet, thereby potentially compromising the sterility of the lancet.

Another problem that needs to be addressed prior to the commercial implementation of integrated lancing test strips is to ensure that a sufficient amount of body fluid is collected at the time of sampling. Desirably, the integrated device only lightly contacts the skin as the body fluid is sampled. If the integrated device is pressed too heavily against the skin, the flow of body fluid from the incision may be blocked, which sometimes results in insufficient sample volume. However, if the test strip is not in contact at all, it may be too far away for the drop of blood to reach the test strip capillary inlet. When sufficient body fluid for testing cannot be collected, the integrated device is typically discarded and the test is performed again with a new integrated device. To further complicate matters, the skin elasticity varies from person to person and from part to part of the body of a single individual, which increases the difficulty of positioning the test strip. For example, children's skin is more elastic than the skin of the elderly. When the sampling device is pressed against the skin, the more elastic child's skin will bend and wrinkle more than the elderly's inelastic skin. The varying heights of the rugosities of the skin from individual to individual increases the difficulty in designing a meter that accurately positions the test strip without contacting the skin, or only slightly contacting the skin, so that fluid flow is not disturbed, yet fluid drops from the incision can still be contacted for the purpose of collecting the fluid.

Therefore, there is a need for further contributions in this area of technology.

SUMMARY

One aspect relates to an integrated lancing test strip with a test strip adapted to analyze body fluid and an enclosure (packet) to which the test strip is coupled. The cuff includes an incision forming member for forming an incision in body tissue. The sterility sheet covers the enclosure to maintain sterility of the incision forming member and prevent cross-contamination between the test strip and the incision forming member. The sterility sheet allows the incision forming member to be sterilized separately from the test strip.

Another aspect relates to a technique in which a sterile envelope is achieved by placing the lancet in a sterile sheet to form a lancet envelope. After the lancet is sterilized, the integrated lancing test strip is assembled by attaching the lancet enclosure to the test strip.

Yet another aspect relates to a meter that includes a holder configured to hold a test strip. An adjustment mechanism cooperates with the holder to position the test strip relative to the body tissue with the incision, which reduces the compressive force applied to the body tissue. By reducing the pressing force applied to the body tissue, the flow constriction (flow constriction) of the body fluid from the incision is reduced when the body fluid is collected with the test strip.

Other forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from the detailed description and the accompanying drawings.

Brief description of the drawings

FIG. 1 is a first top exploded view of an integrated lancing test strip according to one embodiment.

Fig. 2 is a second top exploded view of the integrated lancing test strip of fig. 1.

Fig. 3 is a third top exploded view of the integrated lancing test strip of fig. 1.

FIG. 4 is a top perspective view of the integrated lancing test strip of FIG. 1 with the lancet in an extended position.

Fig. 5 is a bottom exploded view of the integrated lancing test strip of fig. 1.

FIG. 6 is a first bottom perspective view of the integrated lancing test strip of FIG. 1 with the lancet in a retracted position.

FIG. 7 is a second bottom perspective view of the integrated lancing test strip of FIG. 1 with the lancet in an extended position.

FIG. 8 is a first front perspective view of the meter when loaded with the integrated lancing test strip of FIG. 1.

FIG. 9 is a second front perspective view of the meter of FIG. 8 when loaded with the integrated lancing test strip of FIG. 1

FIG. 10 is a rear perspective view of the gauge of FIG. 8

FIG. 11 is a perspective view of the gauge of FIG. 8 with the housing removed

FIG. 12 is a cross-sectional view of the gauge of FIG. 8

FIG. 13 is an enlarged cross-sectional view of the actuator mechanism of the meter of FIG. 8

FIG. 14 is a perspective view of the meter of FIG. 8 when the integrated lancing test strip of FIG. 1 is loaded

FIG. 15 is a perspective view of the cam arm of the meter of FIG. 8 engaging the integrated lancing test strip of FIG. 1

FIG. 16 is a perspective view of the meter of FIG. 8 and the integrated lancing test strip of FIG. 1 prior to lancing.

FIG. 17 is a perspective view of the meter of FIG. 8 and the integrated lancing test strip of FIG. 1 in a lancing state.

FIG. 18 is a perspective view of the meter of FIG. 8 and the integrated lancing test strip of FIG. 1 in a sampling configuration.

Description of selected embodiments

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. Although some features that are not relevant to the present invention may be apparent to those skilled in the relevant art(s) for the sake of clarity, the invention is described in detail below.

One of the many embodiments of the present invention relates to an integrated lancing test strip that includes a unique sterile closure system. The integrated lancing test strip includes a lancet to form an incision that is attached to a test strip to analyze body fluid from the incision. The lancet is at least partially enclosed by a sterility sheet that serves to maintain sterility of the lancet and to simplify manufacturing of the integrated lancing test strip. By enclosing the lancet in a sterile sheet, the lancet can be sterilized separately from the test strip and then attached to the test strip after sterilization. As a result, this separable or modular construction of the lancet and the test strip allows the lancet to be sterilized without adversely affecting the chemical enzymes in the test strip, which can affect the accuracy of the test results. With the sterility sheet, the integrated lancing test strips also have a compact profile, which facilitates the incorporation of a plurality of integrated lancing test strips into a sheet clip, drum, cartridge, insertion cartridge, or the like. In addition, the sterility sheet can reduce cross-contamination between the lancet and the test strip before, during, and after use. In one form, the integrated lancing test strip is loaded into a lancing device or meter configured to fire the lancet. The meter includes an adjustment mechanism that allows the user to adjust the position of the test strip relative to the skin during sampling. The adjustment mechanism allows the user to compensate for factors such as skin elasticity, skin type, body part size and changes in applied compression force, to name a few. An adjustment mechanism may be used to compensate for this different condition to allow the test strip to be positioned close enough to collect a sample of bodily fluid, but too close to impede the flow of bodily fluid from the wound.

First, an integrated lancing test strip or device 20 according to one embodiment of the present invention will be described with reference to FIGS. 1, 2, 3, 4, 5 and 6. Referring to FIG. 1, the integrated lancing test strip 20 includes a lancet assembly or incision forming member 22 for forming an incision in body tissue, a sterile sheet or foil 24 for maintaining the sterility of the lancet, and a test strip 26 for obtaining body fluid from the incision. The lancet 22 and test strip 26 in the illustrated embodiment are both generally flat, such that the integrated lancing test strip 20 has an overall flat appearance. Being flat, the plurality of integrated lancing test strips 20 can be incorporated into a sheet clip, drum, cartridge, insertion cassette, or the like, such that the plurality of integrated lancing test strips 20 can be used without separate loading and/or separate disposal of the used integrated device 20. For example, the generally flat shape allows a plurality of integrated lancing test strips 20 to be stacked on top of each other in a clip or rolled up on a spool inserted into a cartridge. Moreover, the overall flat shape allows for the manufacture of the integrated lancing test strip 20 with a continuous process in which the component material layers are layered to form adjacent strips of the integrated lancing test strip 20 that can be cut into individual units or remain attached for insertion into a cartridge or the like. Nonetheless, it should be appreciated that in other embodiments, the integrated lancing test strip 20 can have other different overall shapes.

As seen in FIGS. 1 and 5, the lancet assembly 22 has a holding element or guide member 28 for guiding a lancet member or lancet 30 during lancing. The lancet 30 can be slidably retained in a guide slot or opening 31, with the guide slot or opening 31 being defined by the retainer 28. The guide slot 31 guides the movement of the lancet 30 during both extension and retraction during lancing. In the illustrated embodiment, the lancet 30 and the holder 28 are separate components that are not directly attached together. However, in another embodiment, the lancet 30 and the holder 28 can be interconnected. For example, the lancet assembly 22 has breakable tabs that connect the lancet 30 to the holder 28 to hold the lancet 30 in a particular position during manufacture and prior to lancing, which can reduce the risk of injury. During lancing, the tabs are broken so that the lancet 30 can extend from the integrated lancing test strip 20. In another example, a spring for retracting the lancet 30 connects the holder 28 to the lancet 30.

As shown, the end stops 32 of the retainer 28 extend inwardly at the slot openings 34 of the guide slot 31 to limit the movement of the lancet 30 so that the lancet 30 is retained in the guide slot 31, as shown in FIG. 7. The lancet 30 has a body portion 35 with one or more stop edges 36 on the body portion 35, the stop edges 36 being wider than the slot opening 34. When the lancet 30 is fully extended, the stop edge 36 of the lancet 30 contacts the end stop 32 and, therefore, the travel of the lancet 30 is limited. However, in other embodiments, the firing mechanism used to fire the lancet 30 can limit the travel of the lancet 30. A neck 37 of the lancet 30, which is slightly smaller than the size of the slot opening 34, extends from the body portion 35 of the lancet 30. The neck 37 is received between the end stops 32 as the lancet 30 is extended so that the end stops 32 can limit undesired rotation of the lancet 30 when body tissue is punctured. The lancet 30 extending from the neck 37 has a blade portion or tip 38 configured to incise body tissue. In the illustrated embodiment, the lancet defines an engagement notch 39 to couple the lancet 30 to the firing mechanism. In one form, the lancet assembly 22 is at least partially made of medical grade stainless steel, but it will be appreciated that the lancet assembly 22 can be made of other materials, such as ceramic and/or plastic. It is also contemplated that the guide member 28 and the lancet 30 can be made of different materials and/or manufactured separately. In one embodiment, the guide member 28 and lancet 30 are formed by a photolithographic technique in which a metal sheet is lithographically printed to form both the guide member 28 and lancet 30, and in another embodiment, the lancet assembly 22 is made by a stamping technique. In still other embodiments, the lancet assembly 22 can be made by other techniques as will occur to those of skill in the art.

Referring to fig. 1 and 2, after the lancet assembly 22 is formed, the lancet assembly 22 can be enclosed within a sterility sheet 24. As will be appreciated from the discussion below, the lancet assembly 22 can be enclosed in the sterility sheet 24 before, during, or after the lancet assembly 22 is sterilized. In the illustrated embodiment, the sterility sheet 24 is a metal sheet, while in another embodiment, the sterility sheet 24 is made of plastic. It will be appreciated that the sterility sheet 24 can be made of other types of materials. In manufacture, the sterility sheet 24 is folded into two flaps 40 with a crease or crease 42 between the two flaps 40, as shown in fig. 1. After folding, the lancet assembly 22 in FIG. 2 is sandwiched between the two flaps 40 so that the fold 42 closes the slot opening 34 of the guide slot 31. As shown in FIG. 3, the flaps 40 are secured to opposite sides (flat sides) of the lancet assembly 22 such that the lancet 30 is sealed within the guide slot 31 and the slot opening 34 is closed by the fold 42. In one form, an adhesive is used to secure the sterility sheet to the guide member 28. Adhesive is applied to the guide member 28 around the guide slot 31 but not to the lancet 30 so that the lancet 30 can still slide within the guide slot 31. Although an adhesive is used in the illustrated embodiment, it should be understood that the sterility sheet 24 and guide member 28 can be sealed in other ways, such as by heat sealing techniques. In the illustrated embodiment, the edges of the flaps 40 are not sealed together, but it is contemplated that in other embodiments, the edges of the sterility sheet 24 can be sealed together to form a pocket that can enclose the entire lancet assembly 22. In another embodiment, instead of crimping the sterility sheet 24, two sterility sheets 24 are bonded together with the lancet assembly 22 sandwiched therebetween. For clarity, the drawings show only how a single integrated lancing test strip 20 is formed, but it is contemplated that in one embodiment, the integrated lancing test strip 20 is formed in a continuous process. In a continuous process, the sterility sheet 24 is a continuous strip that is unwound from a reel and folded around the continuous strip or ribbon of lancet assemblies 22, wherein the lancet assemblies 22 are likewise unwound from the reel.

Once joined together, the lancet assembly 22 and the sterility sheet 24 form a lancet enclosure or sleeve 44. As described above, the lancet assembly 22 can be sterilized before it is enclosed in the sterility sheet 24. The lancet assembly 22 can be sterilized using any of a variety of sterilization techniques as would occur to those of skill in the art, such as by chemical sterilization, thermal sterilization, and/or radiation sterilization techniques, to name a few. It should be understood that all or a portion of the lancet assembly 22 may be sterilized. For example, it is also possible to sterilize only the lancet 30 and the guide groove 31. In another embodiment, the lancet assembly 22 is sterilized after the lancet assembly 22 is enclosed within the lancet enclosure 44. In one form, once the lancet 30 is enclosed by the sterility sheet 24, it is sterilized using radiation sterilization techniques. With the lancet package 44, the lancet assembly 22 can be sterilized without exposing the test strip to undesirable lancet sterilization effects.

In the illustrated embodiment, the test strip 26 is an electrochemical-type test strip. In another particular form, the test strip 26 includes a modified versionBrand test strips (roche diagnostics GmbH), but it is contemplated that other types of test strips may be used. For example, in other embodiments, the test strip 26 may comprise an optical-type test strip, or may otherwise analyze a bodily fluid sample. At one end, the test strip 26 in the illustrated embodiment includes a connection 46 with electrical contacts 47, the electrical contacts 47 communicating the sample indicator value to the meter. Opposite the connection 46, the test strip 26 has a capillary channel 48 with a capillary opening 49, the capillary opening 49 being configured to draw a body fluid sample from the incision formed by the lancet 30 through a wicking action. It should be understood that the test strip within the capillary channel 48The analysis zone 26 includes an analysis region that includes electrodes, such as a working electrode, a counter electrode, a reference electrode, and reagents for analyzing the bodily fluid sample. In one form, the connection 46 is connected to a meter to which sample indicator values from the electrodes of the analysis zone are transferred via electrical contacts.

Turning to fig. 5 and 6, a sterilized lancet package 44 is attached to the test strip 26 to form the integrated lancing test strip 20. As depicted, the lancet package 44 is attached at one end of the test strip 26 to the capillary opening 49 proximate the capillary channel 48. Specifically, the guide slot opening 34 of the lancet assembly 22 and the capillary opening 49 of the test strip 26 are positioned adjacent to each other in a side-by-side relationship such that the capillary channel opening 49 can be positioned in an approximated position for collecting body fluid when the lancet 30 forms an incision. The test strip 26 is attached to the exterior of the sterility sheet 24, and the sterility sheet 24 encloses the lancing member 22 to complete the integrated test strip 20. In one form, the test strip 26 is attached to the lancet package 44 by an adhesive, but it will be appreciated that the test strip 26 and lancet package 44 may be attached in other ways. In one form, the lancet package 44 is attached to the test strip 26 such that the edges of the two are aligned with each other. However, in other embodiments, the edge of the lancet package 44 and the edge of the test strip 26 can be offset from one another. For example, in the illustrated embodiment, the edge of the lancet package 44 is slightly recessed from the edge of the test strip 26 at the capillary opening 49, as demarcated by the fold 42. By recessing the lancet package 44, fluid flow to the capillary channel opening 49 is facilitated. In another example, the sterility sheet 24 is positioned with the crease 42 extending past the edge of the test strip 26. In this example, all or a portion of sterility sheet 24 can be hydrophobic and/or hydrophilic, such that fluid flow can be directed to capillary channel 48. In one particular form, the sterility sheet 24 extends from the test strip 26 such that the sterility sheet 24 serves as a flexible wicking sheet for drawing bodily fluids into the capillary channel 48.

To draw body fluid to the capillary channel opening 49 and away from the lancet 30, the test strip 26 of the illustrated embodiment has a body fluid directing slot 50 facing the lancet package 44. To enhance the flow of bodily fluids to capillary passage opening 49, sterility sheet 24 can be treated and/or made hydrophobic. When the sterility sheet 24 is hydrophobic, the sterility sheet can scrape or scrape body fluid off the lancet 30 as the lancet 30 retracts back into the guide slot 31. It is contemplated that the scraping action of sterility sheet 24 will increase the amount of body fluid sampled and make lance 30 cleaner for disposal. As previously mentioned, the risk of cross-contamination between the lancet 30 and the test strip 26 is reduced when the lancet 30 is sealed within the lancet package 44.

In fig. 3 and 4, the test strip 26 further defines a relief slot 51 through which the blade tip of the cam arm will extend when engaging the lancet 30 during loading and firing. Additionally, the relief groove 51 may be used to vent air from the capillary channel 48 when collecting body fluids. The length of the relief slot 51 is generally close to the length of the lancing stroke of the mechanism used to actuate the lancet 30. When the lancet package 44 is attached to the test strip 26, the engagement notch 39 on the lancet 30 is aligned with the relief slot 51 of the test strip 26. As will be described in greater detail below, the blade tips of the cam arms for the firing mechanism extend through the engagement notch 39 of the lancet 30 into the relief slot 51. In doing so, the blade tip will pierce the sterility sheet 24. Between lancets, the cam arm extends and retracts the lancet 30 relative to the test strip 26 by the blade. When the lancet 30 is extended, the tip 38 of the lancet 30 pierces the sterility sheet 24 at the crease 42, as shown in FIGS. 4 and 7. In one form, the sterility sheet 24 is weakened at the fold 42 to assist the lancet 30 in puncturing it, but in other forms the fold 42 is not weakened. Once the lancet 30 is retracted back into the guide slot 31, as shown in FIG. 6, the two flaps 40 of the sterility sheet 40 can frictionally retain the lancet 30 therein. By engaging the lancet 30 in this manner, the risk of accidental puncturing by the integrated lancing test strip 22 is reduced because it is more difficult to manually and/or accidentally actuate the lancet 30. It should be appreciated that the lancet assembly 22 can incorporate other structures for engaging the lancet 30. For example, the engagement notch 39 on the lancet 30 can be replaced by a projection or knob. It is also contemplated that the lancet can also be fired in a non-mechanical and/or non-contact technique that does not require puncturing the sterility sheet 24. For example, in another embodiment in which the lancet 30 is magnetized, the lancet 30 can be magnetically fired by voice coil actuation. When the lancet 30 is enclosed in the sterility sheet 24 both before and after lancing, the risk of contamination is reduced, as is the risk of accidental injury.

A lancing device or meter 60, according to one embodiment, as shown in fig. 8, 9 and 10, is configured for lancing body tissue and collecting and analyzing body fluid from the body tissue with the integrated lancing test strip device 20. In one embodiment, the meter 60 includes a display screen or other type of output mechanism for outputting sample indicator values from the integrated lancing test strip 20. The meter 60 in the illustrated embodiment is configured to adjust the relative position of the test strip 26 to the skin during sampling. Referring to fig. 8, the lancing device 60 includes a cap 62 configured to contact body tissue and a firing mechanism 63 having a trigger knob 64, the trigger knob 64 being used to actuate the firing mechanism 63. The lancing device 60 further includes an adjustment control or mechanism 66 for adjusting the sampling position of the test strip 26 and a housing 68 with an end plate 69 that houses the components of the lancing device 60. As shown in fig. 8 and 9, the lid 62 is hingedly coupled to the housing 68 so that the lid 62 can be swung open to allow loading of the integrated lancing test strip 20 (fig. 9). The lid 62 further includes a latch 70 having an opening that engages a locking tab 71 on the housing 68 to lock the lid in place after loading of the integrated lancing test strip 20, as shown in FIG. 8. The expression member 72 is coupled to the cap 62, the expression member 72 defining a sampling opening 73, and the lancet 30 lancing the skin through the sampling opening 73 such that the test strip 26 can collect body fluid from the incision. In the illustrated embodiment, the compression member 72 is annular and is threadably coupled to the cap 62 such that the compression member 72 is telescopically movable to adjust the height of the compression member 72 relative to the cap 62. The proximity of the test strip 26 to the target body tissue can be adjusted by the user by rotating the squeezing member 72. This adjustment may be made on an individualized basis based on a number of factors, such as the size of the body part to be sampled and the strength with which the user typically presses against the skin. Surrounding sampling opening 73, compression member 72 has a skin or body tissue contacting surface 74, and contacting surface 74 is configured to contact the skin during lancing and sampling. In the illustrated embodiment, the skin contacting surface 74 is angled inwardly to promote the expression of bodily fluids from the incision when the cap 62 is pressed against the skin.

As can be seen in FIG. 10, the firing mechanism 63 includes a firing button 76, and once in the triggered state, the user may actuate the firing mechanism 63 by depressing the firing button 76. In the illustrated embodiment, the firing mechanism 63 comprises a spring-driven firing mechanism of the type well known to those skilled in the art. To trigger the firing mechanism, the trigger knob 64 is pulled and the potential energy created by pulling the knob 64 is stored by a spring in the firing mechanism 63. When the user depresses the firing button 76, the potential energy stored in the spring is released and this energy is used to fire the lancet 30. After the lancet 30 is fully extended, the firing mechanism 63 is retracted to retract the lancet 30 from the target body tissue. It should be appreciated that the lancing device 60 can also include other types of firing mechanisms known to those skilled in the art, such as a motorized and/or pneumatic type firing mechanism.

The lancing device 60 is shown in FIG. 11 with a portion of the housing 68 removed and in FIG. 12 a cross-sectional view of the lancing device 60 is shown. As shown, the firing mechanism 63 extends through and is secured to an end floor 69 of the housing 68. On the opposite side of the trigger knob 64, the firing mechanism 63 has an actuation arm 80, the actuation arm 80 being configured to extend from the firing mechanism 63 upon a needle stick and to subsequently retract, as indicated by the double arrow 81. In the illustrated embodiment, the actuation arm 80 is rod-shaped, but the actuation arm 80, as well as other portions of the firing mechanism 63, may have shapes other than those shown in further embodiments. To provide a compact configuration for the lancing device 60, the lancing device 60 includes a drive connector 82, and the connector 82 is connected to an actuation arm 80 of the firing mechanism 63. The drive connector 82 is configured to transmit force from the firing mechanism 63 to the actuation assembly 84, which physically fires the integrated lancing test strip 20. In the illustrated embodiment, the drive connector 82 is L-shaped such that the firing mechanism 63 and the actuation assembly 84 may be positioned in a side-by-side relationship to provide the lancing device 60 with an overall compact shape. The actuating assembly 84 includes a bearing block 84, the bearing block 84 having a bearing channel 85 that can receive a bearing rib. A support block 84 is connected to the drive connector 82 and a support rib 86 is secured to the housing 86 by the firing mechanism 63. As the actuation arm 80 of the firing mechanism 63 extends and retracts, the support block 84 slides relative to the support ribs 86.

Referring to fig. 12 and 13, the actuation assembly 84 includes a strip holder 90 for holding and actuating the integrated lancing test strip 20. The strip holder 90 defines a cam arm channel 92 in which a cam arm 94 is rotatably disposed. As shown, the cam arm 94 is rotatably coupled to the retainer 90 by a pivot pin 96, but it should be appreciated that the cam arm 94 and retainer could be rotatably coupled together in other manners. Looking to fig. 13, the retainer 90 further defines a sliding connector arm cavity 98 in which a connector arm 100 is slidably disposed. The connector arm 100 is connected to a connector block or member 102 so that the connector block 100 can slide relative to the holder 90. The connector block 102 defines a connector slot 104, the connector slot 104 being shaped to receive the connection portion 46 of the test strip 26. Within the connector slot 104, the connector block 102 in one form includes electrical contacts that contact the contacts 47 on the test strip 26 to communicate the indicator value from the test strip 26 to the meter 60.

At one end thereof, the cam arm 94 has a cam member or portion 106, the cam member or portion 106 having a cam surface 108 that is angled or tapered to engage the connector block 102. Beside the cam portion 106, the cam arm 94 has a limit tab 110, the limit tab 110 configured to contact the retainer 90 to limit rotation of the cam arm 94. On the opposite side of the cam portion 106, the cam arm 94 has a lancet engaging blade 112, the blade 112 being relatively sharp for puncturing the sterility sheet 24 of the integrated lancing test strip 20. During loading of the integrated lancing test strip 20, the connector block 102 is pushed further into the lancing device 60 and toward the cam portion 106 of the cam arm 104. When the connector block 102 engages the cam surface 108 of the cam portion 106, the cam arm 94 is rotated such that the blade 112 pierces the sterility sheet 24. After cutting the sterility sheet 24, the blade 112 extends into the engagement notch 39 of the lancet 30 to enable the cam arm 94 to hold the lancet 30 during lancing. The relief notch 51 on the test strip 26 ensures that the blade 112 extends completely through the engagement notch 39 so that the cam arm 94 fully engages the lancet 30. In the illustrated embodiment, the integrated lancing test strip 20 is loaded with the lancet assembly 28 facing the blade 112 such that the blade 112 first extends through the engagement slot 39 of the lancet 30 before extending through the relief slot 51 of the test strip 26. It is contemplated that the integrated lancing test strip 20 in other embodiments can be flipped over to be positioned in the opposite manner. That is, when loaded, the test strip 26 faces the blade 112 such that the blade first extends through the relief notch 51 of the test strip 26 to engage the lancet 30. In the illustrated embodiment, the retainer 90 has one or more detent mechanisms 114, and the detent mechanisms 114 engage one or more detent openings 116 in the cam arm 94 to hold the cam arm 94 in place during a needle prick. In one embodiment, detent mechanism 114 includes a ball detent, but it will be appreciated that other types of mechanisms may be used to hold cam arm 94 in place. In the illustrated embodiment, the blade 112 is hook-shaped or angled to facilitate removal of the integrated lancing test strip 20 after sampling and/or testing. Next to the blade 112, a cover 118 is fixed to the holder 90. The cover 118 and the holder 90 together define a test strip retention slot 120 that receives and retains the integrated lancing test strip 20 during lancing and sampling. Referring again to fig. 12, the strip holding slot 120 is aligned with the sampling opening 73 in the lid 70 so that the integrated lancing test strip 20 can sample bodily fluids without obstruction.

As described above, the adjustment control 66 allows the position of the test strip 26 relative to the skin to be adjusted during sampling so that the test strip 26 does not bleed off the incision by pressing too hard on the skin. As shown in fig. 11 and 12, the adjustment control member 66 is threadably secured to the end plate 69, the adjustment control member 66 extending through the end plate 69 and engaging the stop member 122, the stop member 122 facing the connector block 102. At least a portion of the stop member 122 is received in the guide channel 124 (fig. 11) to prevent rotation of the stop member 122 when the adjustment control member 66 is rotated. By twisting the adjustment control 66, the distance between the stop 122 and the connector block 102 may be increased or decreased. In operation, the stop 122 limits the travel of the connector block 102, which in turn limits how far the test strip 26 can be retracted away from the target body tissue, and thus, the distance between the capillary opening 49 of the test strip 26 and the target body tissue surface can be controlled. As a result, the test strip 26 may remain close to or in light contact with the body tissue without risking obstruction of blood flow from the wound. It is contemplated that adjustment mechanism 66 may include other types of adjustment mechanisms. By way of non-limiting example, another form of adjustment mechanism includes a motor capable of moving the stop 122. The position of the stop 122 may be adjusted manually by the user via one or more buttons on the gauge 60 or automatically by the gauge 60. In one form, the meter 60 automatically adjusts the position of the test strip 26 in one form based on the relative position of the skin as obtained by the sonar-type detector and/or the optical detection sensor.

The integrated lancing test strip 20 can form an incision and collect body fluid from the incision using a variety of techniques. In one technique, the test strip 26 remains stationary relative to the lancing device 60, moving the lancet 30 forward and backward to pierce the skin. In another technique, the lancet 30 remains fixed relative to the test strip holder 90 while the test strip 26 can move with the connector block 102. When the test strip 26 contacts the skin, the test strip 26 is pushed back by the skin so that the lancet 30 is exposed to pierce the skin or other body tissue. The test strip 26 can contact the skin without variations in skin height having a significant effect on the penetration depth of the lancet 30.

To facilitate understanding and appreciation of the features of the integrated lancing test strip 20 and meter 60, the body fluid sampling technique will be described with reference to fig. 14, 15, 16, 17, and 18. However, as will be appreciated from the foregoing discussion, other methods of sampling bodily fluids may be used. Referring to FIG. 14, loading of the integrated lancing test strip 20 is accomplished by pushing the integrated lancing test strip 20 into the meter 60, as indicated by the direction of arrow 130. The connection portion 46 of the test strip 26 is received into the connector block 102, as shown in fig. 13. As the integrated lancing test strip 20 is pushed further into the meter 60, the connector block 102 engages a cam surface 108 on the cam arm 94 to rotate the cam arm 94 in a teeter-totter manner. The rotation of the cam arm 94 causes the blade 112 on the cam arm 94 to puncture the sterility sheet 24 on the integrated lancing test strip 20 such that the blade 112 engages the engagement notch 39 in the lancet 30, as shown in FIG. 15. Once the cam arm 94 is rotated to engage the lancet 30, the detent mechanism 114 locks the position of the cam arm 94 to prevent inadvertent disengagement during lancing. As the integrated lancing test strip 20 is advanced further into the meter 60 (fig. 15), the blade 112 on the cam arm 94 forms a slit 132 in the sterility sheet 24, as indicated by the direction of arrow 130. The slits 132 in the sterility sheet 24 allow for smooth movement of the lancet 30 and cam arm 94 during retraction. Once the connector 102 contacts the stop 122, the integrated lancing test strip 20 is fully loaded.

In one embodiment, when the integrated lancing test strip 20 is fully loaded, the lancet 30 remains completely sealed within the pocket formed by the sterility sheet 24 until lancing is initiated. In another embodiment, as shown in FIG. 15, once the integrated lancing test strip 20 is fully loaded, the tip 38 of the lancet 30 slightly pierces the crease 42 of the sterility sheet 42. However, to prevent accidental injury, the tip 38 of the lancet 30 does not extend past the edge of the test strip 26. During loading of the meter 60, the cover 62 of the meter 60 is rotated away in the manner shown in fig. 9. Once loaded, the cover 62 of the gauge 60 is rotated and locked into the firing position, as shown in fig. 8. The firing mechanism 63 is triggered by pulling on the knob 64. Prior to initiating lancing, the sampling opening 73 of the cap 62 is positioned over a target body part or tissue 134, such as the skin 134 of a finger as shown in FIG. 16, such that the compression member 72 contacts the body part 134. It will be appreciated that the firing mechanism 63 may be activated before or after the gauge 60 is placed against the target body part 134.

Referring to fig. 10, 12 and 17, the user depresses the firing button 76 of the firing mechanism 63 to initiate a needle stick. Upon firing, the actuation arm 80 (FIG. 12) extends from the firing mechanism 63 and the drive connector 82 transmits this extending force to the holder 90, thereby causing the holder 90 to likewise move toward the body part 134. As the holder 90 moves, the integrated lancing test strip 20 also moves. When the cam arm 94 is attached to the holder 90 and the blade 112 of the cam arm 94 is secured to the lancet 30, the lancet 30 extends along with the rest of the integrated lancing test strip 20 toward the body part 134. Once the test strip 20 contacts the body part 134, the frictional force causing the test strip 26 to move with the holder 90 cannot move the test strip 26 any further and the test strip 26 rests against the body tissue 134. Although the test strip 26 stops moving, the lancet 30 continues to move because the lancet 30 is still engaged with the cam arm 94 of the holder 90 that is still moving. Thus, upon contacting the body tissue 134, the test strip 26 is pushed back and the tip 38 of the lancet 30 is exposed such that the tip 38 penetrates the body tissue 134, as shown in FIG. 17. The lancet 30 continues to extend until the firing mechanism 63 reaches its maximum stroke length, as indicated by the direction of arrow 135 in FIG. 17. After forming the incision 136 in the body tissue 134, the firing mechanism 63 retracts the holder 90, which in turn retracts the lancet 30 and other portions of the integrated lancing test strip 20. In another embodiment, the test strip 26 does not contact the skin during lancing, but rather, the lancet tip 38 is exposed by contacting the back side of the compression member 72.

As previously mentioned, the adjustment control 66 controls the position of the test strip 26 relative to the body tissue 134 via the stop 122 to prevent constriction of fluid flow from the incision 136. As the holder 90 retracts, the integrated lancing test strip 20 retracts along with the connector block 102 until the connector block 102 contacts the stop 122, thereby limiting retraction of the test strip 26. Although the test strip 26 stops retracting, the cam arm 94 continues to retract along with the lancet 30 in the direction 130, as shown in FIG. 18, such that the lancet 30 retracts into the guide slot 31 of the lancet assembly 22. Once retracted, the lancet 30 can be contained within the sterility sheet 24, which can reduce the risk of accidental injury and reduce bio-contamination exposure during disposal. In one form, the sterility sheet 24 can act as a wiper blade to wipe away body fluid 138 or other contaminants from the lancet 30 so that the integrated lancing test strip 20 is substantially clean after use and when the amount of body fluid required for testing is increased. In one example, the sterility sheet 24 is hydrophobic to enhance the ability to scrape body fluid 138 from the lancet 30.

Referring to fig. 18, the edge of the test strip 26 is spaced slightly from the surface of the body tissue 134, but is still positioned close enough to collect body fluid 138 from the incision 136. It should be noted that the user may twist the adjustment control 66 so that the integrated lancing test strip 20 may be brought into light contact with the body tissue 134 or the test strip 26 may be spaced a distance from the body tissue 134 during sampling, if desired. It is also contemplated that other components such as a flexible wicking sheet or the like may contact the skin during sampling. Behind the capillary opening 49, the lancet 30 is recessed such that when the lancet 30 is retracted, the lancet 30 does not contact the body tissue 134 and is sufficiently behind the capillary opening 49 for the body fluid 138 to reach the capillary opening 49 of the test strip 26 before reaching the opening formed in the sterility sheet 24 by the lancet 30. For example, in one embodiment, the lancet 30 is retracted 0.5mm to 0.75mm behind the capillary opening 49. By recessing the lancet package 44 in the manner shown, expression of the body fluid 138 from the incision 136 is not impeded by the presence of the lancet 30. If desired, the user may apply the meter 30 to the body tissue 134 to cause the expression member 72 to express the body fluid 138 from the incision 136. Once the body fluid 138 begins to flow out of the incision 134, the capillary channel 49 of the test strip 26 collects the body fluid 138. As previously mentioned, the test strip 26 has a notch 50, and the notch 50 directs the flow of fluid toward the opening 39 of the capillary channel 49 and away from the lancet 30.

After a sufficient amount of the body fluid 138 has been collected, the body fluid 138 is analyzed using the test strip 26, and the results of the test are displayed by a display device on the meter 60 and/or transmitted to another device, such as a computer, for further analysis. Once the integrated lancing test strip 20 has been used, the integrated test strip 20 is removed from the meter 60 for disposal. Upon removal of the integrated lancing test strip 20, the lid 62 is pivoted outwardly to allow the user to remove the integrated lancing test strip 20, as shown in FIG. 9. To remove the integrated test strip 20, the user pulls the integrated test strip 20 from the meter 60. Referring to fig. 13, when the user pulls out the integrated test strip 20, the hooked or angled shape of the blade 112 causes the rotating cam arm 94 to rotate away from the integrated lancing test strip 20. This rotational movement disengages the cam arm 94 from the detent mechanism 114, allowing the cam arm 94 to rotate freely. As the integrated lancing test strip 20 is pulled further, the cam arm 94 continues to rotate until the blade 112 disengages from the engagement notch 39 on the lancet 30. After the integrated lancing test strip 20 is disengaged from the cam arm 94, the integrated test strip 20 can be completely removed from the meter 60 for processing or further analysis, if desired. For subsequent testing, a new integrated lancing test strip 20 can be loaded into the meter 60 in the manner described above.

It should be appreciated from the foregoing discussion that the integrated lancing test strip 20 and meter 60 can be used to sample and analyze bodily fluids from various body parts, such as the fingers and other alternative parts, such as the forearm. In addition, the integrated lancing test strip 20 can also be used to analyze a wide variety of different types of bodily fluids, such as bodily interstitial fluid or blood, to name a few. It should also be recognized that the features of the integrated lancing test strip 20 can be modified for use with other types of meters other than those shown in the figures. Rather, the meter 60 described above can also be used with other types of sampling devices other than the integrated lancing test strip 20 described above.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. All publications, patents and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

Claims (23)

1. A body fluid sampling device comprising:

an integrated lancing test strip including a test strip adapted to analyze bodily fluid and an envelope coupled directly to the test strip adapted to analyze bodily fluid;

wherein the envelope comprises

An incision forming member for forming an incision in body tissue, and

a sterility sheet enclosing the incision forming member to maintain sterility of the incision forming member and prevent cross-contamination between the test strip adapted to analyze bodily fluids and the incision forming member, wherein the sterility sheet allows the incision forming member to be sterilized separately from the test strip adapted to analyze bodily fluids;

the body fluid sampling device further comprises a guide member having a guide slot in which the incision forming member is slidably disposed, wherein the guide slot defines a guide slot opening through which the incision forming member extends during lancing; and

wherein the sterility sheet is folded to form two flaps with a crease therebetween, the crease closes the guide slot opening, and the guide member is sandwiched between the flaps to close the guide slot.

2. The device of claim 1, wherein the incision forming member defines an engagement opening that engages the incision forming member during lancing.

3. The apparatus of claim 2, further comprising:

a measuring device comprising

A cam arm having a blade that pierces the sterility sheet to engage the engagement opening of the incision forming member, an

A firing mechanism coupled to the cam arm to fire the incision forming member.

4. The device of claim 3, wherein the meter includes an adjustment mechanism to adjust the position of the test strip adapted to analyze the bodily fluid relative to the bodily tissue at the time of sampling in order to reduce flow constriction of the bodily fluid from the incision.

5. The device of claim 3 wherein the test strip adapted to analyze bodily fluids defines a release opening that aligns with the engagement opening to allow the blade to extend completely through the engagement opening on the incision forming member.

6. The device of claim 2, wherein the test strip adapted to analyze bodily fluid defines a release opening that is aligned with the engagement opening.

7. The device of claim 1, wherein the test strip adapted to analyze body fluid defines a capillary opening into which the body fluid is drawn, and the test strip adapted to analyze body fluid defines a notch positioned proximate the cuff to direct a flow of the body fluid away from the incision forming member.

8. The apparatus of claim 1,

the incision forming member comprises a lancet; and

both the envelope and the test strip adapted for analyzing body fluid are substantially flat so as to allow for a compact assembly.

9. The device of claim 1, wherein the sterility sheet is hydrophobic to scrape bodily fluids from the incision forming member when retracted.

10. The apparatus of claim 1, further comprising:

a mechanism for analyzing the body fluid, wherein the mechanism for analyzing the body fluid comprises the test strip adapted to analyze the body fluid;

a mechanism for forming the incision, wherein the mechanism for forming the incision comprises the incision forming component; and

a mechanism for maintaining the sterility of the incision forming member, wherein the mechanism for maintaining the sterility of the incision forming member comprises the sterile sheet.

11. A method of forming the bodily fluid sampling device of claim 1, comprising: forming said envelope by closing said incision forming member into said sterile sheet;

sterilizing the incision forming member;

assembling the integrated lancing test strip by attaching the enclosure to the test strip adapted to analyze body fluid after sterilizing the incision forming component.

12. The method of claim 11, wherein the sterilizing occurs after the envelope is formed.

13. The method of claim 11, wherein the sterilizing occurs prior to forming the envelope.

14. The method of claim 11,

forming the envelope comprises

Providing a ribbon comprising a plurality of said incision forming elements, and

the band is sandwiched between the sterility sheets by folding the sterility sheets around the band.

15. The method of claim 14, further comprising cutting the integrated lancing test strip from the ribbon.

16. The method of claim 11, further comprising:

creating an engagement opening in the incision forming member;

creating a release notch in the test strip adapted to analyze bodily fluid; and

wherein assembly of the integrated lancing test strip includes aligning the engagement opening of the incision forming member with the release slot of the test strip adapted to analyze bodily fluid.

17. A meter comprising the bodily fluid sampling device of claim 1, comprising:

a holder configured to hold the test strip adapted to analyze a bodily fluid; and

an adjustment mechanism cooperating with the holder to position the test strip adapted to analyze bodily fluid relative to a body tissue having an incision for reducing pressure applied to the body tissue to reduce flow constriction of bodily fluid from the incision when the bodily fluid is collected with the test strip adapted to analyze bodily fluid.

18. The measurer of claim 17, further comprising:

a firing mechanism coupled to the holder to fire and retract the incision forming member toward and from the body tissue.

19. The gauge of claim 18, wherein the adjustment mechanism comprises:

a connector coupled to an end of the test strip adapted to analyze bodily fluid distal from the bodily tissue, wherein the connector is disposed to be slidable relative to the holder; and

a stop member movable relative to the connector to adjust a distance between the stop member and the connector, wherein the stop member is positioned to limit a stroke of the connector when the incision forming member is retracted.

20. The measurer of claim 18, further comprising:

the incision forming member defines an engagement opening;

a connector coupled to one end of the test strip adapted to analyze bodily fluid;

a cam arm rotatably coupled to the holder, wherein the cam arm includes a cam portion and a blade configured to pierce the sterility sheet; and the connector is slidable relative to the holder to contact the cam portion and rotate the cam arm to cause the blade of the cam arm to pierce the sterility sheet and engage the engagement opening in the incision forming member when the integrated lancing test strip is loaded.

21. The gauge of claim 17, further comprising a connector connecting the firing mechanism to the holder in a side-by-side orientation for compactly assembling the firing mechanism and the holder.

22. The measurer of claim 17, further comprising:

a housing in which the retainer is disposed;

a cover coupled to the housing; and

a expression member threadably coupled to the cap to allow the expression member to move relative to the cap in a telescoping manner, wherein the expression member defines a sampling opening through which the test strip adapted to analyze a body fluid samples the body fluid.

23. The measurer of claim 17, further comprising:

a mechanism for holding the test strip adapted to analyze body fluid; and

a mechanism for positioning said test strip adapted to analyze body fluid relative to said body tissue.