HK1121660B - Integrated lancing test strip with retractable lancet - Google Patents

Description

Integrated lancing test strip with retractable lancet

Background

The present invention relates generally to body fluid sampling devices and more particularly, but not exclusively, to an integrated lancing test strip with a unique retractable lancet (lancet).

The acquisition and testing of bodily fluids is useful for many purposes, and is becoming increasingly important in medical diagnosis and treatment, such as 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 particular applications, testing may involve testing of blood and/or interstitial fluid, among others. Various characteristics of the fluids, or analytes contained within the fluids, can be obtained by testing these fluids to identify medical conditions, determine treatment responses, assess treatment progress, and for similar purposes.

Testing of body fluids involves the steps of taking a fluid sample, transferring the sample to a testing device, manipulating the test on the fluid sample, and displaying the results. These steps are typically performed by a plurality of separate instruments or devices. These procedures are difficult for patients, especially those with limited hand dexterity, such as the elderly or those suffering from physiological conditions, such as diabetics. Diabetics suffer from a number of symptoms that make self-monitoring difficult. For example, diabetics can sometimes experience numbness or tremor in their extremities, such as their hands, and wounds tend to heal more slowly in diabetics. In a typical procedure, a patient first lances the skin with a lancet to create an incision in the skin. To ensure that a sufficient number of capillaries can be cut to provide an adequate body fluid sample, the incision must typically be relatively deep, which can be quite painful for the patient. The incision often still does not provide a sufficient amount of sampled bodily fluid and the patient must again express fluid from the incision. If the patient is not careful during the expression of the liquid, the liquid may become contaminated, which may lead to failure of the extracted sample. Once a sufficient amount of fluid is collected as a droplet on the skin, the patient needs to position the test strip in a position to contact and absorb the droplet in a sufficient amount for testing. Often the droplets of fluid are quite small and patients, especially those with hand motor control problems, may experience great difficulty in positioning the test strip when collecting a sample from the droplet. It is to be appreciated that such procedures can be frustrating for patients, and therefore, they may perform the test less often or even stop the test altogether.

More recently, integrated lancing test strips have been developed that incorporate a test strip with a lancet to form a stand-alone disposable unit. While such integrated units have somewhat simplified the collection and testing of liquid samples, there are a number of problems that need to be solved before they can be implemented as a commercial unit. One of the problems relates to the interaction between the lancet and the test strip during fluid collection. In one type of design, the lancet is fixed relative to the test strip and can extend past the edge of the test strip. During lancing, the entire integrated lancing test strip is fired (fire) by the lancing mechanism to form an incision, and after the incision is formed, the entire integrated lancing test strip is typically retracted away from the skin to remove the blade from the incision, thereby promoting blood flow and reducing pain.

With the lancet fixed relative to the test strip, a number of difficulties can be created in sampling the fluid. For example, as described above, the lancet typically extends from the test strip proximate the capillary opening for the test strip. In this position, the lancet blade can interfere with the collection of body fluid by contaminating droplets of blood on the skin and/or drawing blood away from the capillary channel. In addition, the distance that the capillary must be retracted is directly proportional to the length of the lancet blade that extends from the test strip. The greater penetration depth caused by the long lancet blade generally increases the amount of bleeding from the incision, but the large length lancet necessitates a greater retraction of the test strip from the skin, which in turn reduces the chance that blood will be successfully drawn into the capillary channel of the test lancet. Conversely, a short lancet reduces the distance of the test strip from the skin, but a short lancet typically results in a smaller volume of liquid sample from the incision. Here, the retraction of the entire integrated device is sometimes inconsistent and can therefore lead to some unexpected consequences. If the integrated device is retracted too far from the skin, the capillary channel may not be able to contact the liquid droplet on the skin, resulting in an incomplete test or an insufficient amount of sampling required for the test.

Some previous integrated disposable designs have been proposed in which a lancet is secured to a body that holds a separate sensor (sensor) and then rotated into position to collect the body fluid. However, the bodies for this type of disposable are usually made of extruded plastic (extruded plastic), which makes them rather bulky and expensive to manufacture. Due to their bulky nature, disposables of this type are difficult to incorporate into boxes (magazines), drums (drums), cases (cases), cartridges (cartridges), and the like.

To alleviate some of these difficulties, integrated lancing test strips have been developed in which the lancet is movable relative to the test strip. However, this design still has a number of disadvantages. One of the problems relates to the maintenance of the sterility of the lancet to reduce the risk of infection. In practice, conventional plastic or syringe-type caps used to maintain the sterility of typical lancets cannot be incorporated into a movable lancet design for several reasons. In a typical syringe-type cap, the cap seals the lancet, and the cap can be removed by pulling or twisting the cap away from the lancet. However, due to its removable nature, it is difficult, if not practically impossible, to remove the cap from the lancet without destroying the integrated device. For example, the lancet can move when the cover is pulled, which can hinder the removal of the cover, and if pulled too heavily, the lancet can become detached from the rest of the integrated lancing test strip. Another problem associated with movable lancet designs relates to the positioning of the capillary opening in the test strip after lancing. In a typical sampling procedure, one end of the test strip contacts the skin during lancing to control the penetration depth of the lancet, and this end remains in contact with the skin as fluid is collected from the incision. However, the pressing force applied to the skin by the test strip being held against can cause the fluid flow from the incision to contract, and as such, the amount of fluid sample may be too small for accurate analysis. Other systems retract the test strip from the skin, but this is prone to positioning errors that cause the capillary channel opening to be too far from the skin to collect liquid. In either case, secure handling of the integrated device is always important. Because the lancet is movable, it sometimes extends from the test strip after lancing, thereby creating a potential risk of nicking. A spring or other biasing mechanism may be used to bias the lancet into a hidden position within the device, but occasionally the integrated device is subjected to compression or impact that exposes the lancet, creating a risk of puncture after use.

Therefore, further contributions in this area of technology are needed.

Summary of The Invention

One aspect of the present invention relates to an integrated lancing test strip device. The integrated lancing test strip device includes a lancet configured to form an incision in tissue, and a test strip coupled to the lancet for analyzing body fluid. The retention mechanism acts as a detent to hold the lancet in a stationary position relative to the test strip prior to forming the incision. The retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip to reduce the risk of contamination of the body fluid with the lancet during collection of the fluid with the test strip.

Another aspect relates to a unique method of collecting bodily fluids. In this way, the lancet is held in a fixed position relative to the test strip in the integrated lancing test strip device. An incision is formed in tissue by at least a portion of the lancet extending from the test strip. The lancet is released from the fixed position and, after the incision is formed, the lancet is retracted into the integrated lancing test strip device. After the lancet is retracted, the test strip can be used to collect body fluid from the incision.

Yet another aspect relates to an integrated lancing test strip device that includes means for creating an incision in tissue and means for analyzing body fluid from the incision. The device further comprises means for holding the means for creating an incision relative to the means for analyzing body fluid and releasing the means for creating an incision upon application of a force.

Yet another aspect relates to an instrument that includes an integrated lancing test strip device. The integrated lancing test strip device includes a test strip for analyzing bodily fluids. The test strip has a capillary channel with an opening for drawing body fluid by a siphon action. The test strip is flat. The lancet is directly coupled to the test strip for forming an incision in tissue. An actuation device is coupled to the integrated lancing test strip device. The actuation device is configured to fire the lancet into the tissue. The actuation device is configured to rotate the lancet away from the incision to reduce interference by the lancet as body fluid from the incision is drawn into the capillary channel of the test strip.

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

Brief description of the drawings

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

FIG. 2 is a bottom view of the FIG. 1 integrated device with the lancet in a static position.

FIG. 3 is a bottom view of the FIG. 1 integrated device with the lancet in a retracted position.

Fig. 4 is the integrated device of fig. 1 lancing the skin to form an incision.

FIG. 5 is the integrated device of FIG. 1 collecting fluid from an incision.

FIG. 6 is a side view of an actuation device for firing the integrated device of FIG. 1.

Fig. 7 is a side view of the device of fig. 6 during lancing.

FIG. 8 is a side view of the FIG. 6 device with the lancet retracted.

Fig. 9 is a side view of the device of fig. 6 during sampling with the device of fig. 1 wiped across the incision.

FIG. 10 is a top view of an integrated lancing test strip device according to another embodiment.

Fig. 11 is a bottom view of the integrated device of fig. 10.

FIG. 12 shows the device of FIG. 10 lancing the skin to form an incision.

FIG. 13 shows the FIG. 10 device with the lancet retracted from the incision.

FIG. 14 shows the FIG. 10 device with the lancet in a fully retracted position for collecting fluid from the incision.

FIG. 15 is a top view of an integrated lancing test strip device according to yet another embodiment.

FIG. 16 shows the device of FIG. 15 lancing the skin to form an incision.

FIG. 17 shows the FIG. 15 device with the lancet retracted from the incision.

FIG. 18 shows the device of FIG. 15 positioned to sample bodily fluid from the incision.

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 further 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. One embodiment of the invention is described in detail below, but some features that are not relevant to the invention are not shown for the sake of clarity, as will be apparent to those skilled in the relevant art.

An integrated lancing test strip or disposable according to one of many embodiments of the present invention includes a test strip and a lancet. The lancet is attached to the test strip such that the lancet is initially in a static (non-movable) position relative to the rest of the test strip, but can move into the device after lancing the skin. In one embodiment, frangible tabs are used to hold the lancet in place, while in another embodiment, tabs in the device act as detents to engage and hold the lancet in place. This ability to secure the lancet in place prior to lancing gives the device the ability to use a conventional protective cap to maintain the sterility of the lancet. By securing the lancet in place, the protective cap can be relatively easily pulled or twisted away from the lancet, either manually or automatically. Once the cap is removed, the integrated disposable, which is the lancing component, is fired by the lancing mechanism to create a body fluid sampling incision. After the incision is created, the lancet is retracted (moved) into the device so that the lancet is moved away from the incision, thus clearing the obstruction to the capillary channel of the test strip from contacting and collecting bodily fluids. With the obstruction cleared, body fluid can then be easily drawn into the capillary channel of the test strip without interference from the lancet with sample collection. In one form, the lancet is retracted in a linear fashion, and in another form, the lancet is rotated during retraction. The lancing device housing the integrated lancing test strip includes a firing mechanism for firing the integrated device, a stabilizer strip, a lancet stabilizer arm, and a deflection arm. The deflection arm bends the integrated disposable toward the sweeping motion of the sampling droplet to improve contact with the sample. In yet another embodiment, the lancet remains stationary after lancing, but the entire integrated lancing test strip is rotated such that the capillary channel offset from the lancet is rotated into position over the incision.

An integrated lancing test strip device or disposable 30 according to one embodiment of the present invention is shown in FIGS. 1, 2 and 3. As shown in FIG. 1, the integrated device 30 includes a test strip 32, the test strip 32 being coupled to a lancet 34. In the illustrated embodiment, the test strip 32 is an electrochemical type test strip, but it should be recognized that other types of test strips can be used, such as colorimetric or optical type test strips, to name a few. The test strip 32 includes a connector portion 36 with electrical contacts that connect the integrated device 30 to a sampling device or meter so that the integrated device 30 can transmit test results to the meter. The test strip 32 also includes an analysis portion or region 38 in which the liquid sample is analyzed.In one form, the analysis portion 38 includes reagents and electrodes, such as working, counter and reference electrodes, for analyzing the liquid sample. The test strip 32 includes a capillary channel 40 having a capillary channel opening 41 to transport body fluid to the analysis portion 38. The analysis section 38 is located at one end of the capillary channel 40, opposite the capillary channel opening 41. The capillary channel 40 is sized and configured to enable the wicking of bodily fluids from the channel opening 41 onto the analysis portion 38. The illustrated capillary channel 40 is Y-shaped, but it is contemplated that in other embodiments the channel 40 may be shaped differently. To assist in drawing liquid, the capillary channel 40 may include a discharge opening or slot. Moreover, the integrated lancing test strip 30 has a generally flat profile in the illustrated embodiment. Because flat, the integrated device 30 can be formed by sandwiching sheets of various components together to form a stand-alone integrated device 30. The flat shape also allows multiple integrated devices 30 to be grouped together into, for example, boxes, drums, magazines, cartridges, and the like, to allow multiple tests without having to reload the meter with additional integrated devices 30. It should be recognized that the integrated device 30 may also be loaded and used in a meter on a separate substrate. In one particular form, the test strip 32 includes ACCU-CHEKBrand test strips (Roche Diagnostics GmbH), but it is contemplated that other types of test strips could be used. Moreover, it is contemplated that in other embodiments, the integrated device 30 may have a different overall shape. By way of non-limiting example, the integrated device 30 in other embodiments may have a circular overall shape.

With continued reference to FIG. 1, the lancet 34 is sealed within a protective cover 42 to maintain the sterility of the lancet 34. In one form, the cap 42 is a plastic cover that can be pulled or twisted away from the lancet 34 prior to use. The cover 42 may be manually removed by a user and/or automatically removed by a meter. It is contemplated that boot 42 may take other forms. For example, in another embodiment, the protective cover 42 comprises two sheets of film that are peeled off the lancet 34 prior to use. Turning to FIG. 2, the integrated device 30 includes a lancet guide channel 44 in which the lancet 34 is disposed. In one form, a sheet or layer of material covers the lancet channel 44 to retain the lancet 34 within the lancet channel 44. The lancet channel 44 extends longitudinally along the integrated device 30 such that the lancet is retracted in a linear manner. It should be understood that in other embodiments, the lancet channel 44 can be shaped otherwise to allow the lancet 34 to retract in other manners. In one embodiment, the lancet channel 44 is formed directly in the test strip 32, while in another embodiment, the channel 44 is defined by a separate spacer component that is attached to the test strip 32. It should be understood that the lancet channel 44 can be defined in other ways as well. In the illustrated embodiment, the lancet 34 is generally flat, but in other embodiments, the lancet 34 can be circular or have other overall shapes. In the illustrated embodiment, the lancet channel 44 that receives the lancet 34 and the opening 41 of the capillary channel 40 are longitudinally aligned with each other on opposite sides of the test strip 32 such that the capillary channel opening 41 is positioned in close proximity to the incision formed by the lancet 34 to facilitate fluid collection. It should be understood from the description of the other embodiments that in other embodiments, the lancet 34 and the capillary channel opening 41 are offset from one another.

Within the lancet channel 44, the device 30 has a retention mechanism or structure 45 that acts as a detent mechanism to hold the lancet 34 in place relative to the test strip 32 prior to lancing and to allow the lancet 34 to retract into the lancet channel 44 after lancing. With the retention structure 45, the protective cover 42 can be easily removed from the lancet 34 without damaging the integrated lancing test strip 30. For example, if the integrated device 30 does not have the retention mechanism 45, the lancet 34 may be completely removed from the lancet channel 44 by a pulling and/or twisting action when the cover 42 is removed. In the depicted embodiment, the retention mechanism 45 is configured to frictionally retain the lancet 34 within the lancet channel 44 after lancing, as shown in FIG. 3. This, in turn, eliminates the need to place the cover 42 or some other protective structure over the lancet 34 after use, and also reduces the chance of injury during handling. Some typical integrated lancing test strip designs with movable lancets require springs to retract and bias the lancet into the test strip so that the lancet is covered during processing. However, springs can be expensive, especially for high volume items such as disposable integrated lancing test strips, and are not always strong enough to retain the lancet within the test strip to prevent accidental cuts. It should be appreciated that the retention mechanism 45 eliminates the need for a spring in the integrated device, and as such, the above-mentioned difficulties are reduced or even eliminated. Although not required, it is contemplated that in other embodiments, a spring can be used in conjunction with the retention mechanism 45 to maintain the lancet 34 within the lancet channel 44.

As shown in FIGS. 2 and 3, the retention mechanism 45 includes one or more frangible tabs 46 that secure the lancet 34 to the wall of the lancet channel 44. As shown, two frangible tabs 46 connect two opposing sides of the lancet 34 to the test strip 32. The tabs 46 in this embodiment prevent longitudinal movement as well as rotational movement of the lancet 34. The tabs 46 can also be used to hold the lancet 34 within the integrated device 30 after the incision is formed, by frictional engagement with the lancet 34. The projections 46 are configured to break when a particular force is applied to retract the lancet 34. In one form, the frangible tabs 46 are made of a breakable plastic material that is strong enough to hold the lancet 34 in place during lancing, but that is also capable of breaking to allow retraction of the lancet 34. It should be understood that the projections 46 may be made of other materials. Moreover, it is contemplated that the retention mechanism 45 can include other types of mechanisms and/or structures for holding the lancet 34 relative to the test strip 32 such that the lancet 34 can be released by the application of a force. For example, the retention mechanism 45 can include an adhesive that is applied between the lancet 34 and the test strip 32. The adhesive holds the lancet 34 in place during lancing, but releases the lancet 34 when a predetermined (or greater) force is applied between the lancet 34 and the test strip 32 during retraction. In another embodiment, a ball and spring type detent mechanism is used to hold the lancet 34 in place. It is contemplated that in other embodiments, the retention mechanism 45 can be configured to release the lancet 34 and allow the lancet 34 to move once the protective cover 42 is removed from the lancet 34.

The lancet 34 has an engagement hole or opening 48 defined in a body 50 of the lancet 34 that is used to engage the lancet 34. Although the engagement hole 48 in the embodiment is circular, the engagement hole 48 can be other shapes in other embodiments and/or include other types of structures for coupling the lancet 34 to a lancing device. In fig. 2 and 3, a lancet tip or blade 52 for puncturing the skin or other tissue extends from the lancet body 50. In the illustrated embodiment, the lancet body 50 is wider than the lancet tip 52. At the interface between the lancet body 50 and the tip 52, the lancet 34 has a depth penetration edge 53 that limits the penetration of the lancet 34 into the skin or other tissue.

Prior to lancing, the retention mechanism 45 in one embodiment holds the lancet 34 with the lancet tip 52 extending from the test strip 32, as shown in FIGS. 1 and 2. With this arrangement, the entire integrated device 30 can be fired against the skin, with the tabs 46 breaking as the lancet 34 retracts within the lancet channel 44. As shown in FIG. 4, the locking tabs 46 hold the lancet 34 fixed in position during lancing so that the lancet tip 50 extends from the test strip 32 during lancing of the skin. A penetration edge 53 on the lancet 34 limits the penetration depth of the lancet tip 52 into the skin or tissue. The penetrating edge 53 also provides a reference surface for vertically spacing the edge of the test strip 32 from the skin 54, which in turn promotes blood flow through the incision 56. As described above, contact between the test strip 32 and the skin 54 creates a pressing force that constricts the flow of fluid to the incision. By spacing the test strip 32 from the skin 54 in this manner, the likelihood of fluid flow constriction is reduced. At the same time, this also ensures that the test strip 32 is not spaced too far from the skin 54 to collect an adequate sample of body fluid 58, such as blood, interstitial fluid and other fluids.

Prior to lancing the skin 54, the skin 54 may be stimulated to promote fluid flow, if desired. After the incision 56 is formed in the skin 54, the lancet 34 is retracted into the lancet channel 44 of the device 30, as shown in FIG. 5. During retraction, the lancet 34 will move, but the test strip 32 remains vertically stationary relative to the skin 54, thus maintaining the separation between the test strip 32 and the skin 54. Because the lancet 34 is located inside the integrated device 30, the lancet 34 does not interfere with fluid collection. After the incision 56 is formed, the body fluid 58 may be expressed from the incision 56, either manually or automatically, in a manner known to those skilled in the art. As the body fluid 58 flows out of the incision 56, the fluid 58 is drawn into the capillary passage 40 by siphoning. It should be appreciated that a portion of the integrated lancing test strip 30 can be hydrophobic and/or hydrophilic to direct the flow of liquid. The liquid 58 is then drawn into the analysis zone 38 where the liquid 58 is analyzed and the results of the analysis are transmitted to the meter via the connector portion 36. The tabs 46 help retain the tip 52 of the lancet 34 within the channel 44 after the lancet 34 is retracted, thus reducing the risk of accidental skin punctures when handling the integrated device 30. By securing the lancet 34 relative to the test strip 32 during lancing, and thereafter allowing the lancet 34 to retract independently of the test strip 32, the spacing of the test strip 32 from the skin 54 can be accurately determined and maintained, thereby facilitating collection of the body fluid 58 from the incision 56.

In another embodiment, the retention mechanism 45 holds the lancet 34 stationary prior to lancing, while the lancet tip 52 is positioned within the integrated device 30 in the manner shown in FIG. 3. By positioning the lancet tip 52 within the integrated device 30 prior to use, the risk of accidental injury caused by the lancet 34 is reduced. The opening of the lancet channel 44 is sealed to maintain sterility, and/or the integrated device 30 can be packaged in other ways to maintain sterility. In this embodiment, the tabs 46 break during lancing so that the lancet 34 can move relative to the test strip 32 both when extended and when retracted. After lancing, the frictional engagement between the frangible tabs 46 and the lancet 34 helps to retain the lancet 34 within the integrated device 30.

The actuation device (or meter) 60 shown in FIG. 6 is used to fire and retract the integrated lancing test strip device 30 shown in FIG. 1. It should be appreciated, however, that the device 60 may also be used to actuate other types of integrated lancing test strips, such as for the other embodiments described herein. As shown, the device 60 includes a lancing mechanism 62 for firing the lancet 34, and a connector 64 that connects the integrated device 30 to the lancing mechanism 62. In one form, the lancing mechanism 62 includes a motor, such as an electric or pneumatic type motor, while in another form, the lancing mechanism 62 is a spring-driven device. It is to be appreciated that the lancing mechanism 62 can include other types of functionally similar devices, as would occur to one skilled in the art. Connector 64 engages test strip connector 36 to transmit the test results to a signal converter or meter that processes the results. The device 60 further includes a lancet stabilizer/retractor arm 66 with an engagement member or pin 68, the engagement member or pin 68 being configured to engage the engagement hole 48 in the lancet 34. In conjunction with the lancing mechanism 62, the retractor arm 66 is configured to retract the lancet 34 into the integrated device 30. The device 60 further incorporates a deflection mechanism 70 for deflecting the test strip 32 to deflect the capillary channel 40 in the test strip 32 over the incision 56 to collect the body fluid 58.

As shown, the deflection mechanism 70 includes a deflection arm 72 and a test strip stabilizer 74. The deflection arm 72 and the strip stabilizer 74 each include opposing cam surfaces 76, 78, the opposing cam surfaces 76, 78 engaging one another to bend the strip stabilizer 74. The strip stabilizer 74 further includes an engagement portion or pillow button (block) 80 that engages the integrated lancing test strip 30. To deflect the test strip 32, the deflection arm 72 is extended by the lancing mechanism 62. As the deflection arm 72 extends, the cam surface 76 on the deflection arm 72 pushes against the cam surface 78 on the strip stabilizer 74. This action bends the strip stabilizer 74 to push the pillow button 80 against the test strip 32. As a result, the test strip 32 bends such that the opening 41 of the capillary channel 40 wipes across the incision 56.

Fig. 7, 8 and 9 show the operation and configuration of the actuation device 60 during the lancing, retraction and sampling phases, respectively. As shown in fig. 7, the connector 64 along with the retractor arm 66 are fired in unison by the lancing mechanism 62 to fire the integrated device 30 against the skin 54. As shown in FIG. 8, the lancet 34 forms an incision 56 in the skin 54, and after the incision 56 is formed, the retractor arm 66 retracts the lancet 34 away from the skin 54 while the connector 64 remains fixed in position. So that the tabs 46 in the lancet channel 44 break to allow the lancet 34 to move relative to the test strip 32 and the lancet 34 to retract into the integrated device 30. Droplets of body fluid 58 from the incision 56 form on the skin 54. To collect the liquid 58, the deflection mechanism 70 sweeps the test strip 32 over a droplet of the liquid 58. It should be noted that by retracting the lancet 34 within the integrated device 30, the overall flexibility of the test strip 32 can be increased to facilitate bending of the test strip 32. Referring to FIG. 9, the lancing mechanism 62 extends a deflection arm 72 toward the skin 54. As the deflection arm 72 extends, the cam surface 76 on the deflection arm 72 pushes against the cam surface 78 on the test strip stabilizer 74. This action bends the test strip stabilizer 74 causing the pillow button 80 to push against the test strip 32. Thus, the test strip 32 bends so that the opening 41 of the capillary channel 40 wipes across the incision 56. This sweeping of the test strip 32 over the incision 56 may occur only once or may be repeated a number of times. The liquid 58 drawn into the capillary channel 40 is analyzed as described above and the results of the analysis are transmitted to the meter via connector 64.

An integrated lancing test strip device 84 according to another embodiment is shown in FIGS. 10 and 11. It can be seen that the integrated device 84 of fig. 10 has many of the same features as the previously described embodiments. For the sake of clarity and brevity, these common features will not be described in great detail, but reference is made to these features in the foregoing discussion. The integrated device 84 includes the test strip 32, as described above, with the connector 36 for connection to a meter. As before, the test strip 32 has a capillary channel 40 with a capillary opening 41, and an analysis portion 38 for testing a body fluid sample.

On the opposite side of the capillary channel 40, the integrated device 84 in FIG. 11 has a lancet 86 that is pivotally coupled to the test strip 32. The lancet 86 in the illustrated embodiment retracts in a rotational manner, rather than in a longitudinal or linear manner. Specifically, the lancet 86 is pivotally coupled to the test strip 32 by a pivot pin 88. The lancet 86 and the pivot pin 88 are positioned within a lancet channel 90, the lancet channel 90 being generally circular to allow the lancet 86 to rotate while reducing the size of the lancet channel 90. It should also be appreciated that in other embodiments, the lancet channel 90 can be shaped otherwise. The lancet 86 includes a lancet body 50 with a lancet tip 52 extending from the lancet body 50 for forming an incision in the skin. The lancet body 50 is wider than the lancet tip 52 to form a penetrating edge 53, and the penetrating edge 53 is used to control the penetration depth of the lancet 86 and to position the capillary opening 40 perpendicularly relative to the skin. The lancet body 50 defines one or more pivot openings 92 located radially outward from the pivot pin 88 to allow torque to be applied to rotate the lancet 86. In the illustrated embodiment, the lancet 86 has two pivot openings 92 located on opposite sides of the pivot pin 88. It should be understood that the lancet 86 can have more or less pivot openings 92 than shown, and that the pivot openings 92 can be shaped differently. It should be further appreciated that the lancet 86 can be modified to be rotated by other types of mechanisms.

The integrated device 84 in FIG. 11 has a retention mechanism or structure 93 that acts as a detent mechanism to secure the lancet 86 relative to the test strip 32. In the fig. 11 embodiment, the retention mechanism 93 includes one or more retention pins or recesses (dimple) 94. The lancet 86 is held rotationally fixed or immovable relative to the test strip 32 by two retaining pins 94 positioned on opposite sides of the lancet 86 when the lancet 86 is in the extended position. In one form, the pin 94 is in the form of a plastic projection that extends within the lancet channel 90, but it should be understood that the pin 94 can be formed of other materials. The pins 94 may also be oriented in other ways than those shown. It is further contemplated that other types of retention mechanisms or structures 93 may be used. In the illustrated embodiment, the lancet tip 52 is covered by the protective cover 42 to maintain the sterility of the lancet 86 and prevent accidental puncturing. As described above, by having the lancet 86 in an immovable state, the protective cap 42 can be easily removed prior to use. In another embodiment, prior to use, the lancet 86 is positioned such that the lancet tip 52 is located within the lancet channel 90, as shown in FIG. 14. As the lancet tip 52 enters the lancet channel 90, the risk of accidental injury is reduced. To maintain the sterility of the lancet 86, the opening of the lancet channel 90 can be sealed and/or the entire integrated device 84 can be packaged in a sterile enclosure.

Fig. 12, 13 and 14 illustrate various stages of sampling fluid from an incision with the integrated lancing test strip 84. Turning to FIG. 12, the entire integrated device 84 is fired against the skin 54 with the lancet 86 in an immovable position with the lancet tip 52 extending from the test strip 32. The retention pin 94 holds the lancet 86 in a fixed position relative to the test strip 32. After the incision 56 is made in the skin 54, the lancet 86 is retracted by a rotational motion, as shown in FIGS. 13 and 14. Prior to rotating the lancet 86, the integrated device 84 in one embodiment is pulled slightly away from the skin 54 so that the lancet tip 52 is removed from the incision 56. In another embodiment, the lancet 86 is rotated to enlarge the incision 56 while it is still in the incision 56. By enlarging the incision 56, a greater amount of body fluid 58 will flow out of the incision 56 at a given penetration depth. If desired, after the incision 56 is formed, the liquid 58 may be automatically or manually squeezed from the incision 56.

To rotate the lancet 86, in one embodiment, the opposing pin openings 92 are engaged by a modified stabilizer/retractor arm 66 (FIG. 6), the modified stabilizer/retractor arm 66 including two engagement pins 68 for engaging the pin openings 92. In this embodiment, the modified retractor arm 66 includes a motor to rotate the engagement pin 68. However, in other embodiments, other mechanisms that perform similar functions, such as pneumatic motors, linkages, pulleys, and the like, can be used. Moreover, it is contemplated that the lancet 86 can be rotated in other manners. When pressure is applied as rotation begins, the retaining pin 94 allows rotation of the lancet 86. As shown in FIG. 14, the lancet 86 continues to rotate until one side of the lancet 86 engages both retaining pins 94 so that the lancet tip 52 is inside the integrated device 84. If desired, the lancet 86 can be further rotated and locked in a particular position such that the lancet tip 52 extends away from the incision 56. With the retention pin 94 engaged to one side of the lancet 86, the lancet 86 cannot protrude from the test strip 32 unless an external force is applied. Likewise, droplets of body fluid 58 can be drawn into the capillary channel 40 of the test strip 32 without the lancet 86 interfering with fluid collection. In one form, the modified version of the actuator device 60 of fig. 6 can be used to bend the test strip 32 to sweep the test strip across the incision 54. In another embodiment, the test strip 84 may collect liquid without a bending or sweeping motion. It is contemplated that a portion of the integrated device 84 may be manufactured, treated, and/or configured to be hydrophobic or hydrophilic to direct the flow of the bodily fluid 58. For example, in one form, the lancet channel 90 is coated with a hydrophobic coating such that the bodily fluid 58 is directed away from the lancet channel 90.

An integrated lancing test strip device 100 according to another embodiment that collects liquid with a rotational motion will be described with reference to FIGS. 15, 16, 17, and 1-8. As shown in fig. 15, the integrated device 100 shares many of the same features as the previously described embodiments. Again for the sake of clarity and brevity, these common features will not be described in great detail below, but reference may be made to the foregoing description of these features.

As noted above, some of the aforementioned integrated disposable designs have been proposed in which the lancet is secured to a body that holds a separate sensor that is then rotated into position to collect the bodily fluid. However, the main body of this type of disposable is usually made of extruded plastic (extruded plastic), which makes them rather bulky and expensive to produce. Due to their bulky nature, disposables of this type are difficult to incorporate into boxes, drums, magazines, cylinders. In contrast, the shape of the integrated lancing test strip 100 of the FIG. 15 embodiment is generally flat and compact, which makes the integrated lancing test strip 100 ideal for use in cartridges, drums, magazines, cartridges, and the like. The integrated lancing test strip 100 of FIG. 15 is also simpler to manufacture compared to previous disposable designs. For example, in one embodiment, the integrated lancing test strip 100 is formed by laminating or adhering a series of strips or sheets of material, which is desirable for a continuous manufacturing process. The integrated lancing test strip 100 can also omit a separate body.

As shown, the integrated device 100 includes a test strip 102 with a connector portion 36 and a lancet 104 coupled to the test strip 102. In the illustrated embodiment, the lancet 104 is secured to the test strip 102. In other embodiments, however, the lancet 104 is movably coupled to the test strip 102, such as described in the previous embodiments. For example, the lancet 104 can be coupled to the test strip 102 via a detent mechanism that allows the lancet 104 to retract inside the integrated device 100 so that the lancet 104 does not interfere with fluid collection. In the fig. 15 embodiment, test strip 102 is an electrochemical-type test strip, but it is to be understood that other types of test strips, such as colorimetric-type test strips, may be used. As can be seen, the lancet 104 is offset from the central longitudinal axis 106 of the integrated device 100 such that the lancet 104 extends along one side of the test strip 102 parallel to the longitudinal axis 106. To provide a compact profile, the lancet 104 in the illustrated embodiment is generally flat, and the lancet 104 includes a lancet tip 52 for forming an incision in tissue, and a body portion 50 that connects the lancet tip 52 to the rest of the lancet 104.

Referring to fig. 15, test strip 102 defines a capillary channel 108 having an analysis portion 38 for analyzing a bodily fluid sample. The capillary channel 108 has an opening 110 that is offset from the longitudinal axis 106 of the test strip 102 and is inclined at an angle 112 relative to the longitudinal axis 106. In one form, the angle 112 between the capillary opening 110 and the longitudinal axis 106 is an oblique angle. As shown, the capillary passage 108 has a boomerang (boomerang) shape, while the capillary passage opening 110 is Y-shaped and has a curved opening. However, it is contemplated that in other embodiments, the channel 108 may be differently shaped. The illustrated test strip 102 is generally rectangular, with the exception that the test strip 102 has a truncated corner 114 at the capillary channel opening 110. The truncated corner 114 allows the capillary channel opening 110 to rotate in the incision position without the test strip 102 contacting the skin or body fluid droplets, which could potentially cause fluid contamination.

By the ability to rotate the lancet 104 away, the capillary channel 108 is able to collect a bodily fluid sample without interference from the lancet 104 with the sample collection. In some embodiments, the integrated device 100 is rotated between 30 ° and 180 ° to collect the liquid sample. To reduce rotation of the test strip 102, the lancet 104 and the capillary channel 108 are positioned near the same end of the test strip 102. However, it is also contemplated that the lancet 104 and the capillary channel 108 can be positioned differently for other embodiments. For example, the orientation of the lancet 104 and the capillary channel 108 can be reversed such that the capillary channel 108 extends parallel to the longitudinal axis 106 and the lancet 104 extends in a non-parallel manner relative to the longitudinal axis 106. In one form, the integrated lancing test strip 100 can be manually rotated by the user after the incision is formed, while in another form, the meter automatically rotates the integrated lancing test strip 100. To automatically rotate the integrated device 100, the integrated device 100 includes a coupling structure 114 that allows a retrofit of the actuation device 60 of FIG. 6 or some other type of meter to rotate the integrated device. In the illustrated embodiment, the test strip 102 has one or more engagement holes 116, and the test strip 102 is held and rotated by the engagement holes 116. It is contemplated that other types of coupling structures having different configurations may be used to rotate the integrated device 100.

Referring now to fig. 16, 17 and 18, the various stages of collecting and analyzing a bodily fluid sample with the integrated device 100 are shown. As shown in FIG. 16, the lancet 104 can be used to lance the skin 54 by firing the entire integrated lancing device 100 toward the skin 54. After the skin 54 is cut, the entire integrated device 100 is retracted from the skin 54 to facilitate fluid flow from the incision 56, as shown in FIG. 17. If desired, after the incision 56 is formed, the body fluid 58 is expressed, either manually or automatically, by stimulating the skin 54 surrounding the incision 56. Once a sufficient amount of fluid 58 has collected on the skin 54, the entire integrated device 100 is rotated to enable the capillary channel 108 to collect the body fluid 58 from the incision 56, as shown in FIG. 18. The test strip 102 is rotated so that the lancet 104 moves away without obstructing the capillary 108 of the test strip 102 from the body fluid 58. In embodiments where the lancet 104 is not secured to the test strip 102, the lancet 104 can be retracted within the integrated device 100 to further reduce the likelihood that the lancet 104 will interfere with fluid collection and reduce the risk of accidental sticks by the lancet 104. As described above, the integrated device 100 can be rotated manually by the user, such as by repositioning the entire meter, or automatically by the meter rotating the entire integrated lancing device 100. The body fluid 58 is then drawn into the analysis zone 38 by the capillary channel 108 and the sample is analyzed in the analysis zone 38. In the illustrated embodiment, the integrated device 100 is connected to a signal converter or meter via a test strip connector 36, and the analysis results are transmitted to the meter via the connector 36.

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 (15)

1. An integrated lancing test strip device (30), comprising:

a lancet (34) configured to form an incision in tissue,

a test strip (32) coupled to the lancet for analyzing the body fluid from the incision, an

A retention mechanism (45) that holds the lancet in a fixed position relative to the test strip prior to the incision being formed, wherein when in the fixed position, at least a portion of the lancet extends from the test strip and an incision is formed by the lancet with the portion extending from the test strip, and the retention mechanism is configured to release the lancet to retract the lancet relative to the test strip to reduce interference caused by the lancet during collection of the body fluid with the test strip.

2. The device of claim 1, further comprising a protective cover covering at least a portion of the lancet, wherein the retention mechanism retains the lancet during removal of the protective cover.

3. The device of claim 1, wherein the retention mechanism comprises one or more frangible protrusions coupled between the lancet and the test strip, wherein the frangible protrusions are configured to fracture upon application of a predetermined force to allow retraction of the lancet.

4. The device of claim 1, wherein the retention mechanism comprises one or more retention pockets that engage the lancet, wherein the pockets are configured to release the lancet upon application of a predetermined force to allow retraction of the lancet.

5. The device of claim 1, wherein the lancet is configured to retract in translation relative to the test strip.

6. The device of claim 1, wherein the lancet is rotatably coupled to the test strip for rotational retraction relative to the test strip.

7. The device of claim 1, wherein the lancet defines one or more engagement openings for transmitting force during retraction.

8. The device of claim 1, wherein the retention mechanism is configured to hold the lancet in a retracted position after the incision is formed to reduce the risk of injury during handling of the integrated lancing test strip device.

9. The apparatus of claim 1, further comprising:

an actuation mechanism coupled to the integrated lancing test strip device, wherein the actuation mechanism includes a deflection mechanism configured to sweep the test strip over bodily fluids from the incision.

10. The device of claim 9, wherein the actuation mechanism comprises a retraction mechanism configured to apply a force to release the lancet from the holding mechanism and retract the lancet.

11. An integrated lancing test strip system, comprising:

the integrated lancing test strip device of claim 1, and

an actuation device coupled to the integrated lancing test strip device, the actuation device configured to rotate the lancet away from the incision to reduce interference caused by the lancet as body fluid from the incision is drawn into the capillary channel of the test strip.

12. The integrated lancing test strip system of claim 11, wherein:

the lancet is pivotably coupled to the test strip; and

the actuation device is configured to rotate the lancet relative to the test strip.

13. The integrated lancing test strip system of claim 11, wherein:

the lancet is fixed to the test strip;

the capillary channel is angled in a non-parallel manner with respect to the lancet;

the actuation device is configured to rotate the lancet from the incision by rotating the entire integrated lancing test strip device.

14. The integrated lancing test strip system of claim 13, wherein the test strip has a truncated corner at the capillary channel opening to reduce contamination of the bodily fluid when the integrated lancing test strip device is rotated.

15. The integrated lancing test strip system of claim 11,

wherein the actuation device incorporates a deflection mechanism to deflect the test strip such that the capillary channel in the test strip is deflected over the incision to collect body fluid.