HK1116646A - Disposable lancet and lancing cap combination for increased hygiene - Google Patents

Description

Disposable lancet and lancing cap combination for improved hygiene

Background

The present invention relates generally to bodily fluid sampling devices, and more particularly, but not exclusively, to disposable lancet and lancet cap sampling devices and techniques for sampling fluid with such devices.

The acquisition and detection of body fluids is useful for many purposes and is of growing importance for use in medical diagnostics and therapy and in other diverse applications. In the medical field, it is desirable for the placement operator to routinely, quickly and reproducibly test outside of a laboratory environment and obtain rapid results. Detection may be performed on a variety of bodily fluids, and for certain applications, particularly with respect to detection of blood and/or interstitial fluid. Such fluids may be tested for a variety of fluid characteristics or for analytes contained within the fluid to identify medical conditions, determine treatment response, and assess treatment progress, among other things.

For example, a common medical test is to measure blood glucose levels for diabetes. Diabetics must test their blood glucose levels several times a day. Blood glucose levels may be determined directly by analyzing a blood sample or indirectly by analyzing other fluids, such as interstitial fluid. Other medical tests may analyze a bodily fluid sample for various characteristics or components, as is well known in the art. For example, such analysis can be performed on hematocrit, cholesterol, uric acid, coagulum, and the like.

The detection of a body fluid basically involves the steps of obtaining a fluid sample, transferring the sample to a detection device, detecting the fluid sample and displaying the result. These steps are typically performed in a plurality of separate instruments or devices.

In one form, a body fluid sampling device includes a lancet that forms an incision and a micro-collection tube that collects body fluid. However, lancing and collecting are two separate actions, which require hand coordination and dexterity to perform both actions. This is often difficult for elderly or pre-adults.

Another form of collecting a body fluid sample is to use an aspiration type blood collection device. The device establishes suction between the lancing position and the device end when the lancet retention mechanism is retracted after puncturing the skin. A flexible gasket around the end of the device assists in sealing the end around the puncture site while the user attempts to draw a sample from the puncture site or the user pulls back on the device to release the seal. The septum over the puncture site may also create a vacuum. Such devices only draw bodily fluids while the device and skin create a vacuum to create suction pressure. However, after the air is expelled, the suction pressure will cease and no additional body fluid will be collected.

An alternative form of collecting and measuring body fluid uses coaxial syringes and capillaries arranged within a spacing member. The spacing member limits the penetration depth of the injector and forces body tissue around the injector when the injector is within the skin to improve the flow of interstitial fluid to the incision. However, it will be appreciated that the slit will tend to close against the syringe thus limiting any advantages that may be achieved.

One problem associated with some lancing devices that control or adjust the depth of penetration to reduce lancing pain is that the blood lancet device does not collect blood from the incision.

Some forms of disposable lancing devices include plastic injection devices that can alternatively be used as syringe-like injection devices and lancing devices with disposable solid needle lancets depending on the configuration. However, such devices do not collect a body fluid sample.

One problem associated with some lancing devices is that the device must be cleaned to maintain proper hygiene between uses of the instrument and to prevent cross-contamination and/or contamination. Cross-contamination of blood samples can be a problem if more than one person uses the device and the device is not properly cleaned between each use. Contamination of blood samples can be a problem if one uses the device repeatedly without properly cleaning the device between each use.

In experimental settings, body fluid samples are often collected from a patient and then transferred to a test device in a controlled manner. For example, some blood glucose monitoring systems require a body fluid sample to be applied to a test disposable in contact with a test instrument. In such cases, directly contacting the patient's incised finger or other incised body part with the detection disposable has some risk of contamination by the bodily fluids of the preceding patient. In particular in a hospital setting, a patient is lanced with such a system, the sample is collected by capillary action in a microtube and then the sample is supplied from the tube to a detection disposable. However, this technique also creates problems of hygiene and cross-contamination and is inconvenient because it requires the use and disposal of three components, the test disposable, the lancet and the blood collection set.

Another problem associated with some lancing devices is that the fingertip is typically lanced to obtain an adequate blood sample and repeated lancing of the fingertip can be painful due to the high concentration of nerves at the fingertip. Thus, alternate locations on the body with fewer nerve endings may provide a weaker pain zone to sample blood or other bodily fluids. However, these alternative locations may produce less body fluid when lancing than the tips of the fingers. It is therefore important to reduce the amount of fluid required to be detected at the alternate locations. To adequately detect body fluid obtained from an alternate site, sufficient fluid must be expressed and collected from the incision before the fluid can be detected.

Yet another problem associated with some lancing and testing devices is that such devices are disposed of independently of each other thus creating additional hazardous waste.

Accordingly, there is a need for improvements in this area.

Disclosure of Invention

One aspect of the present invention is directed to a body fluid testing device that includes a test strip mounted to a housing to form a chamber. The cavity slidably receives the incision forming member. The test strip has a skin-contacting portion that includes an expression surface to express fluid from the incision.

A further aspect relates to a body fluid testing device. The apparatus includes a housing having an opening to receive the sheet from the incision forming member. The opening controls the penetration depth into the skin as the sheet of the incision forming member slides in the opening and the incision forming member penetrates the skin.

Yet another aspect relates to a body fluid testing device. The device includes a housing with an extension member to contact the skin and a test strip attached to the housing. The test strip and the extension member define a channel sized and arranged to draw bodily fluid from an incision in the skin by capillary action. The incision forming member forms an incision in the skin and is partially received within the channel.

Another aspect relates to a method of sampling bodily fluid. The method includes providing a body fluid sampling device comprising an incision forming member, a test strip, and a housing. An incision is formed in the skin with an incision forming member. The test strip includes an expression surface that expresses bodily fluid from the incision. The housing and test strip form a chamber or channel for collecting body fluid from the incision by capillary action. The device includes means for analyzing body fluid from the incision site. Further aspects include processing of the body fluid testing device.

Another aspect relates to a method of sampling bodily fluid. The method includes providing a body fluid sampling device comprising an incision forming member, a test strip, and a housing. An incision is formed in the skin with an incision forming member. The housing and test strip are pressed against the skin surrounding the incision to express fluid from the incision. The housing and test strip form a chamber for collecting body fluid from the incision by capillary action. The test strip analyzes the body fluid from the incision.

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

Drawings

FIG. 1 is a first cross-sectional view of a body fluid testing device in a retracted position according to one embodiment.

FIG. 2 is a second cross-sectional view of the body fluid testing device of FIG. 1 in an extended position.

Fig. 3 is a perspective view of the apparatus of fig. 1.

Fig. 4 is an exploded view of the apparatus of fig. 1.

Fig. 5 is a rotated view of the device of fig. 1 prior to forming an incision in skin.

FIG. 6 is a rotated view of the FIG. 1 device forming an incision in skin.

Fig. 7 is a view of the rotation of the device of fig. 1 during expression of fluid from the skin.

Fig. 8 is a perspective view of a body fluid testing device according to a second embodiment.

Fig. 9 is an exploded view of the apparatus of fig. 8.

Fig. 10 is an exploded view of a body fluid testing device according to a third embodiment.

Fig. 11 is a perspective view of the device of fig. 10 in a retracted position.

Fig. 12 is a perspective view of a body fluid testing device according to a fourth embodiment.

Fig. 13 is an exploded view of the apparatus of fig. 12.

FIG. 14 is a rotated view of the FIG. 12 device prior to forming an incision in skin.

FIG. 15 is a rotated view of the FIG. 12 device forming an incision in skin.

Fig. 16 is a view of the rotation of the device of fig. 12 during expression of fluid from the skin.

FIG. 17 is a third cross-sectional view of the body fluid testing device of FIG. 1 in a retracted position with a retraction mechanism.

FIG. 18 is a fourth cross-sectional view of the body fluid testing device of FIG. 1 in an extended position with an actuation mechanism.

FIG. 19 is a fifth cross-sectional view of a body fluid testing device according to a fifth embodiment in a retracted position.

FIG. 20 is a fifth cross-sectional view of the body fluid testing device of FIG. 19 in an extended position.

Fig. 21 is a perspective view of the apparatus of fig. 19 in an extended position.

Fig. 22 is an exploded view of the apparatus of fig. 19.

FIG. 23 is a rotated view of the FIG. 19 device prior to forming an incision in skin.

FIG. 24 is a rotated view of the FIG. 19 device forming an incision in skin.

Detailed Description

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. It will thus be appreciated that those skilled in the art to which the invention relates will readily appreciate that many alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein.

One embodiment of the present invention generally relates to a disposable body fluid testing device that reduces the number of steps involved in forming an incision, collecting a body fluid sample from the incision, and testing the body fluid sample. A body fluid testing device or cartridge includes an incision forming member, a housing, and a test strip having an expression surface. The test strip is attached to the housing to form a cavity within which the incision forming member is slidably received. In one form, the cavity is sized to draw fluid by capillary action. In another form, the test strip is configured to draw fluid by capillary action. The body fluid testing device is operable by slidably moving an incision forming member to form an incision in a person's skin. More particularly, the bodily fluid detection apparatus is operable to lance the skin with the incision forming member and express bodily fluid from the incision with the expression surface. The expression surface forces fluid out of the incision. In another embodiment, body fluid is expressed from the incision by pressing the test strip and housing against the skin surrounding the incision. In one embodiment, after lancing the skin, the incision forming member is retracted into the cavity, and the body fluid is collected by capillary action through the cavity and tested with a test strip. In another embodiment, the incision forming member is retracted into the cavity after lancing the skin and the test strip is configured to collect and test body fluid from the incision. In another embodiment, for increased hygiene, it is contemplated that the body fluid testing device may be disposed of after testing the body fluid sample. Another body fluid testing device must be used for the next testing of the body fluid sample. For example, a user disposes of the device after one use of the body fluid testing device and uses another body fluid testing device when the user needs to test the body fluid at a later time.

A cartridge or body fluid testing device 30 according to one of the embodiments of the present invention will now be described with reference to fig. 1, 2, 3 and 4. As depicted in fig. 1, the body fluid testing device 30 includes a test strip 40 for analyzing a body fluid.

In the illustrated embodiment, as depicted in FIG. 1, test strip 40 includes a skin contacting portion 42 and a distal portion 44. The skin contacting portion 42 includes an expression surface 46 capable of expressing fluid from the incision. The expression surface 46 facilitates fluid flow from the incision site, such as by applying pressure to a region near the incision to draw or withdraw fluid from the incision. Test strip 40 can analyze the fluid by, for example, optical (e.g., reflectance, absorbance, fluorescence, RAMAN, etc.) devices, electrochemical (e.g., amperometric, potentiometric, or coulometric) devices, and/or magnetic analysis. In one embodiment, test strip 40 optically analyzes the fluid with a chemical reagent. In another embodiment, test strip 40 electrochemically analyzes the fluid with soluble chemical reagents and/or reagents that are immobilized to the electrodes. In other embodiments, test strip 40 may have other shapes. For example, test strips 40 may be rectangular, cylindrical, or oval in shape, etc. to form test strips 40, to name a few. The test strip is a commercially available test strip, for example from Roche Diagnostics under the trade name ACCU-CHEK GO^®The test strip of (1) or a trademark name ACCU-CHEK COMPACT from Roche Diagnostics^®The test strip of (1).

As can be seen from fig. 1, 2 and 4, the body fluid testing device 30 comprises an incision forming member 50 for forming an incision in the skin of a person. The incision forming member 50 includes a sampling portion 52 and an opposing end 54. The incision forming member 50 also includes a test strip facing surface 56 and a housing facing surface 58. In one form, the surface 56 facing the test strip is coated with or made of a hydrophilic material to enhance capillary action or affinity. In another form, the housing facing surface 58 is coated with or made of a hydrophobic material to repel bodily fluids toward the test strip facing surface 56. It is contemplated that in other embodiments the incision forming member 50 is coated with or made of a combination of hydrophobic and hydrophilic materials to direct fluid toward the test strip 40. By directing fluid to the test strip 40, the amount of fluid required for testing may be reduced. The incision forming member 50 is configured to form an incision in skin. In the illustrated embodiment, the incision forming member 50 includes a needle 60 for forming an incision. The incision may include any opening in the skin that allows access to bodily fluids. In the illustrated embodiment, the needle 60 forms an incision but it should be appreciated that in other embodiments the incision forming member 50 may include other devices to form an incision or to lacerate the skin. For example, incision forming member 50 may include a lancet, a laser, a blade, and/or a high velocity fluid stream to form an incision, to name a few. The needle 60 includes a needle tip 62 for contacting the skin and a needle end 64. The incision forming member 50 is configured to slidably engage within the cavity 66. The cavity 66 encloses the incision forming member 50. In one embodiment, the cavity 66 is sized to draw fluid by capillary action. In another embodiment, the cavity 66 is sized such that the expression surface 46 draws fluid. Different materials may have different affinities for the fluid, such that forming the expression surface 46 and the sampling portion 52 in different materials will provide a change in capillary affinity between these portions. Capillary affinity is also altered by treating or coating the expression surface 46, for example to provide a resulting surface that is more or less hydrophilic. In addition, capillary affinity is also altered by treating or coating the sampling portion 52 and/or the surface 56 facing the test strip to provide a more or less hydrophilic resulting surface. The present invention is operable in any manner in which capillary affinity is varied. In another embodiment, the incision forming member 50 has a tab 68. When the tab 68 is engaged by an actuation mechanism of a type well known to those skilled in the art, the tab 68 actuates the incision forming member 50. In the illustrated embodiment, the sheet 68 has a generally rectangular shape, but it should be appreciated that the sheet 68 may be shaped differently in other embodiments. For example, the sheet 68 may be circular or oval in shape.

As depicted in fig. 1, 2, and 4, the body fluid testing device 30 includes a housing 70 attached to the test strip 40, the housing 70 forming the cavity 66. The housing 70 includes a first portion 72 and an opposing second portion 74. As depicted in fig. 4, the housing 70 also includes an inner surface 76 and an outer surface 78. In one embodiment, the housing 70 includes an opening 80 configured to receive the tab 68 of the incision forming member 50. In the illustrated embodiment, the opening 80 has a generally rectangular shape, but it should be appreciated that the opening 80 may be shaped differently in other embodiments. By way of non-limiting example, the opening 80 may be a slot, slit, or rectangle with rounded ends or any other shape that matches the shape of the tab 68. In the illustrated embodiment, the tab 68 slides within the opening 80. The length of the opening 80 is advantageous in the illustrated embodiment because it determines the extent of movement of the tab 68 and the depth of penetration of the incision forming member 50 into the skin of a person. In another embodiment, an actuation mechanism may be coupled to the tab 68 to further limit the movement of the tab 68 within the opening 80.

The depth of penetration of the incision generally controls the production of fluid, particularly in conjunction with the characteristics of the incision location. The present invention is useful for various body fluids, including blood or interstitial fluid. The body fluid testing device may be configured to produce blood or interstitial fluid, for example, by controlling the distance that the incision forming device extends into the skin of a user. For example, a depth of 0.25mm to 4mm will typically produce blood from the dermis, while a depth of 0.05mm to 0.5mm will produce interstitial fluid from the epidermis.

As depicted in FIGS. 1 and 3, test strip 40 is attached to housing 70 such that a cavity 66 is formed in which incision forming member 50 is slidably received. However, it should be appreciated that test strip 40 may be attached to housing 70 in other manners. By way of non-limiting example, the test strip 40 may be attached to the housing 70 by an adhesive, a clip mechanism, a weld and/or a snap mechanism, etc., to name a few. Still further, test strip 40 and housing 70 may be molded as one body instead of two separate attachable elements. In the illustrated embodiment, the housing 70 has a semi-tubular shape and the incision forming member 50 has a semi-cylindrical shape. In the illustrated embodiment, the semi-tubular shape of the housing 70 is advantageous because it is easy to manufacture and grasp by a user. It should be appreciated that the housing 70 and the incision forming member 50 may be shaped differently in other embodiments. For example, the housing 70 may be a rectangular container and the incision forming member 50 may be rectangular in shape. In the illustrated embodiment, the cavity 66 has a semi-cylindrical shape, but it should be appreciated that the cavity 66 may be shaped differently in other embodiments.

As can be seen in FIGS. 3 and 4, test strip 40 is attached to housing 70 to align skin contacting portion 42 with first portion 72. The skin contacting portion 42 and the first portion 72 express fluid from the incision, such as by applying pressure to the area surrounding the incision to draw or withdraw fluid from the incision. By way of non-limiting example, the skin contacting portion 42 and the first portion 72 express fluid by, for example, applying pressure to the skin surrounding the incision and/or squeezing or compressing the skin surrounding the incision.

The operation of the body fluid testing device 30 according to one embodiment will now be described with reference to fig. 1, 2, 5 and 6. Fig. 1 and 5 illustrate the relative positions of the incision forming member 50 such that the needle tip 62 is retracted towards the distal portion 44 of the test strip 40 beyond the skin contacting portion 42 before the body fluid testing device 30 is placed on the user' S skin S. The incision forming member 50 is retracted by a retraction mechanism as shown in fig. 17. The retraction mechanism 51 has an arm 53 coupled to the tab 68 to retract the incision forming member 50. In an alternative embodiment, arm 53 of retraction mechanism 51 is coupled to end portion 54 to retract incision forming member 50. The opening 80 that receives the tab 68 limits the movement of the incision forming member 50. The skin contact portion 42 is placed against the skin S. Fig. 2 and 6 illustrate the relative positions of the incision forming member 50 after the end portion 54 is driven toward the sampling portion 52 to lance the user' S skin S with the needle tip 62 to form the incision I. The incision forming member 50 can be actuated or driven toward the skin S using an actuation mechanism of a lancing device such as that shown in fig. 18. The actuation mechanism 61 has an arm 63 coupled to a tab 68 to drive the incision forming member 50 towards the skin S. In an alternative embodiment, the arm 63 of the actuation mechanism 61 is coupled to the end portion 54 to drive the incision forming member 50 towards the skin S. After the incision I is made in the skin S, the needle tip 62 is withdrawn from the user' S skin S. Fig. 1 and 5 also illustrate the relative position of the incision forming member 50 after the sampling portion 52 is retracted towards the end 54, thereby removing the needle tip 62 from the user' S skin S. In one form, the incision forming member 50 can be retracted by a retraction mechanism as shown in fig. 17. The arm 53 of the retraction mechanism 51 is attached to the tab 68 to move the tab 68 within the opening 80 and thereby retract the incision forming member 50. In another form, an arm 53 of a retraction mechanism 51 is attached to the end portion 54 to retract the incision forming member 50.

FIG. 7 illustrates the expression of body fluid from the incision I with the skin contacting portion 42 remaining in contact with the skin S, according to one embodiment. When the sampling portion 52 is withdrawn from the skin S, the body fluid B is expressed from the incision I. In one form, the expression surface 46 presses against the skin S to facilitate the flow of fluid B out of the incision I. In another form, the skin contacting portion 42 of the test strip 40 and the first portion 72 of the housing 70 are pressed against the skin S to facilitate the flow of fluid B from the incision I. The skin contacting portion 42 and the first portion 72 express fluid B from the incision I, for example by applying pressure to the skin S around the incision I to draw or withdraw fluid B from the incision I. In one form, the cavity 66 collects fluid B from the incision I by capillary action after expressing the body fluid B. The body fluid B is also drawn by capillary action of the cavity 66 onto the test strip 40 for testing. In another form, expression surface 46 of test strip 40 is configured to collect body fluid B after body fluid B is expressed. Further, the extruding surface 46 is coated with a hydrophilic material to collect the body fluid B by capillary action.

As should be appreciated, the body fluid testing device 30 shown in fig. 1, 2, 5, 6 and 7 improves the speed of use and ease of use of the device for simultaneously expressing body fluid and collecting the body fluid for testing. Because the expression surface 46 and the cavity 66 are combined into one device, the user will quickly be able to express and collect bodily fluids. It should be appreciated that the body fluid testing device 30 is useful for alternate site testing where sufficient fluid must be expressed and collected from the incision to test the fluid. In one embodiment, the body fluid testing device 30 is disposable, thus leaving the retraction mechanism and/or actuation mechanism for later use with another body fluid testing device 30. In the illustrated embodiment, the body fluid testing device 30 is arranged as a single unit, thus reducing hazardous waste.

In one embodiment illustrated in fig. 8 and 9, body fluid testing device 30 includes an end cap 90 to detachably cover a front portion 92 of testing device 30. The end cap 90 includes a front end wall 94 opposite a rear end 96, the rear end 96 being configured to store the front portion 92. In the illustrated embodiment, the end cap 90 is semi-cylindrical in shape. In other forms, the end cap 90 may be rectangular, oval, elliptical, or any other shape that fits the front portion 92. The rear end 96 includes an opening 98 for storing the needle tip 62 and the needle 60. A variety of configurations may be used to attach end cap 90 to front portion 92. For example, the end cap 90 may be pushed onto the front portion 92. To use the test device 30, the end cap 90 is removed from the front portion 92. In one form, the end cap 90 may be separated from the front portion 92 by turning, rotating or pulling the end cap 90 relative to the front portion 92. As should be appreciated, other forms of attaching and/or detaching end cap 90 from front portion 92 may be used.

It should be appreciated that the placement of the end cap 90 on the front section 92 protects the sterility of the needle tip 62 and needle 60. Further, the end cap 90 is separated from the front section 92 for use to expose the needle tip 62. After use of the body fluid testing device 30, the end cap is placed over the front portion 92. As should be appreciated, placement of end cap 90 onto front portion 92 after use of body fluid testing device 30 ensures safe and hygienic disposal of testing device 30 by enclosing front portion 92 contaminated with body fluid.

Fig. 10 and 11 illustrate a body fluid testing device 30 according to an alternative embodiment of the present invention. As depicted in fig. 10, the incision forming member 50 and the housing 70 are detachably molded to form one body. In the illustrated embodiment, the incision forming member 50 is attached to the housing 70 by a pair of connectors 100. The pair of connectors 100 are made of any material that allows the incision forming member 50 to be separated or detached from the housing 70. By way of non-limiting example, the connector 100 may be made of a flexible plastic material or rubber, to name a few. In one embodiment, during the manufacturing process, the housing 70 is rotated such that the openings 80 are aligned onto the tabs 68 of the incision forming member 50. In another embodiment, in operation of the body fluid testing device 30, the user will rotate the housing 70 such that the opening 80 is aligned over the tab 68 of the incision forming member 50. Opening 80 receives sheet 68. Test strip 40 is attached to housing 70. As illustrated in fig. 11, the needle tip 62 is retracted toward the distal end portion 44 of the test strip 40 beyond the skin contacting portion 42. In one form, the pair of connectors 100 are moved away from the incision forming member 50 and the housing 70 to separate the end portions 54 of the incision forming member 50 from the second portion 74 of the housing 70. In another form, the pair of connectors 100 are used to separate the end portions 54 of the incision forming member 50 from the second portion 74 of the housing 70. As should be appreciated, the removal and/or disconnection of the pair of connectors 100 releases the movement of the incision forming member 50 relative to the housing 70. However, in other forms the pair of connectors 100 are configured to allow unrestricted movement of the incision forming member 50 relative to the housing 70.

In an alternative embodiment illustrated in fig. 12 and 13, the body fluid testing device 30 includes an extension 110. Extension 110 has a skin contacting portion 112 for contacting the skin and a distal portion 114 for contacting first portion 72. Extension 110 extends from first portion 72 into alignment with skin contacting portion 42 of test strip 40. In one form, extension 110 and test strip 40 are aligned in a parallel relationship. Incision forming member 50 is configured to be slidably engaged within cavity 66, however sampling portion 52 cannot extend beyond distal portion 114. The alignment of extension 110 and test strip 40 forms channel 120. In one form, the channel 120 is sized to draw fluid by capillary action or affinity. In another form, the channel 120 is sized such that the test strip surface 46 draws fluid. Different materials may have different fluid affinities, such that forming the expression surface 46 and extension 110 from different materials will provide a change in capillary affinity between these portions. Treating or coating the expression surface 46 to provide a resulting surface that is more or less hydrophilic changes the capillary affinity. Capillary affinity may also be altered by treating or coating the extension 110 to provide a resulting surface that is more or less hydrophilic. The present invention is operable in any manner in which capillary affinity is varied.

The operation of the body fluid testing device 30 will now be described with reference to fig. 12, 14 and 15. In fig. 14 and 15, the test strip 40 is removed for clarity. Fig. 12 and 14 illustrate the relative positions of the incision forming member 50 such that the needle tip 62 is retracted towards the distal end portion 114 beyond the skin contacting portion 112 before the body fluid testing device 30 is placed on the user' S skin S. The incision forming member 50 is retracted by a retraction mechanism, wherein the retraction mechanism is coupled to the tab 68 to retract the incision forming member 50. In another form, a retraction mechanism is coupled to end portion 54 to retract incision forming member 50. The opening 80 that receives the tab 68 limits the movement of the incision forming member 50. The skin contact portion 42 is placed against the skin S. Fig. 15 illustrates the relative position of the incision forming member 50 after the end portion 54 has been driven toward the sampling portion 52, thereby driving the needle tip 62 through the channel 120 and into the skin S of the user such that the needle tip 62 forms an incision I. A needle tip 62 or other device that forms an incision in the skin extends through the channel 120 beyond the extension 110 to form an incision in the skin. The incision forming member 50 can be actuated or driven toward the skin S using an actuation mechanism of the lancing device. An actuation mechanism may be coupled to the tab 68 or the end portion 54 to drive the incision forming member 50 toward the skin S. Also illustrated in fig. 14, the needle tip 62 is withdrawn from the user' S skin S and the sampling portion 52 is withdrawn toward the end portion 54.

FIG. 16 illustrates the expression of bodily fluids from the incision I with the skin contacting portion 42 and the skin contacting portion 112 held in contact with the skin S, according to one embodiment. When the sampling portion 52 is withdrawn from the skin S, the body fluid B is expressed from the incision I. The skin contacting portion 42 and the skin contacting portion 112 express bodily fluid B from the incision I, such as by applying pressure to the skin S around the incision I to draw or withdraw bodily fluid B from the incision I. The capillary action through the channel 120 draws the body fluid B onto the test strip 40 for testing. When body fluid B is expressed, the expressed surface 46 of test strip 40 collects body fluid B.

In another embodiment illustrated in fig. 19, 20, 21 and 22, body fluid testing device 30 includes a cover 130 to attach test strip 40 to housing 70. The cover 130 extends from the second portion 74 of the housing 70 toward the first portion 72 of the housing 70. In the illustrated embodiment, the cover 130 is adhesively attached to the housing 70. By way of non-limiting example, the cover 130 may be attached to the housing 70 by a clip mechanism, welding, and/or by a snap mechanism, to name a few. The incision forming member 50 is configured to slidably engage within the channel 140. The alignment of test strip 40 and housing 70 forms a channel 140. In one form, the channel 140 is sized to draw fluid by capillary action or affinity. In another form, the channel 140 is sized such that the test strip surface 46 draws fluid. Different materials may have different fluid affinities such that an expression surface 46 and sampling portion 52 formed of different materials will provide a capillary affinity that varies between these portions. Treating or coating the expression surface 46 to provide a resulting surface that is more or less hydrophilic changes the capillary affinity. Capillary affinity may also be altered by treating or coating the expression surface 46 to provide a resulting surface that is more or less hydrophilic. The present invention is operable in any manner in which capillary affinity is varied.

As shown in fig. 21, the incision forming member 50 includes a sheet 68. A retraction mechanism or actuation mechanism is coupled to the tab 68 to limit the movement or motion of the incision forming member 50 within the channel 140. In the embodiment illustrated in fig. 23, the retraction mechanism 51 has an arm 53 coupled to a tab 68 to retract the incision forming member 50. The test strip 40 in fig. 23 and 24 is removed for clarity. In operation, the arm 53 of the retraction mechanism 51 retracts the needle tip 62 toward the distal end portion 44 of the test strip 40 beyond the skin contacting portion 42. As shown in fig. 24, the actuating mechanism 61 has an arm 63 coupled to a tab 68 to actuate the incision forming member 50. The arm 63 of the actuating member 61 is coupled to the tab 68 to drive the incision forming member 50 towards the skin S to form an incision I with the needle tip 62 in the skin of the user. After forming the incision I in the skin S, the needle tip 62 is withdrawn from the user' S skin S by retracting the incision forming member 50. In the illustrated form, the incision forming member 50 is retracted by an arm 53 of a retraction mechanism 51, as shown in fig. 23. The arm 53 of the retraction mechanism 51 is attached to the tab 68 to move the tab 68 thereby moving the needle tip 62 away from the user' S skin S and retracting the incision forming member 50.

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 scope of the invention are desired to be protected.

Claims (18)

1. A bodily fluid sampling device, comprising:

a disposable cartridge, comprising:

an incision forming member configured to be actuated to form an incision in skin,

a test strip for detecting body fluid from an incision, the test strip having an expression surface configured to express body fluid from the incision when pressed against skin, and

a housing coupled to the test strip, the housing and the test strip defining a cavity configured to draw bodily fluid onto the test strip by capillary action, wherein the incision forming member is slidably disposed within the cavity.

2. The body fluid testing device of claim 1, further comprising an actuation mechanism.

3. The body fluid testing device of claim 2, wherein:

the disposable cartridge is detachably coupled to the actuation mechanism to allow processing and replacement of the cartridge; and

the incision forming member is actuated by an actuation mechanism.

4. The body fluid testing device of claim 2, wherein:

the housing includes an opening;

the incision forming member includes a sheet slidably engaged with the opening; and

wherein the tab actuates the incision forming member to form the incision when the tab is engaged by the actuation mechanism.

5. The body fluid testing device of claim 2, wherein the actuation mechanism is operable to retract the incision forming member into the cavity to draw fluid from the incision into the cavity.

6. The body fluid testing device of claim 1, further comprising a retraction mechanism; and

the incision forming member is detachably coupled to the retraction mechanism to allow retraction of the incision forming member.

7. The body fluid testing device of claim 1, wherein the incision forming member comprises a needle.

8. The body fluid testing device of claim 1, wherein:

the housing has a semi-tubular shape; and

the incision forming member has a semi-cylindrical shape.

9. The body fluid testing device of claim 1, wherein the expression surface is coated with a hydrophilic material.

10. The body fluid testing device of claim 1, wherein the incision forming member is coated with a hydrophilic material.

11. The body fluid testing device of claim 1, wherein the housing includes one or more connectors to connect with the incision forming member.

12. The body fluid testing device of claim 11, wherein the connector is made of a flexible material.

13. The body fluid testing device of claim 11, wherein the connector is configured to separate from the incision forming member.

14. The body fluid testing device of claim 1, further comprising:

a cover covering the incision forming member to protect sterility of the incision forming member; and

wherein the incision forming member, the test strip, and the housing are configured to receive a cover.

15. The body fluid testing device of claim 1, wherein the test strip is configured to generate a signal to analyze the body fluid from the incision.

16. The body fluid testing device of claim 15, wherein the test strip has a wicking surface to transport body fluid to the test strip.

17. A body fluid testing device, comprising:

an actuating member; and

a disposable cartridge detachably coupled to an actuation member, the cartridge comprising:

an incision forming member configured to be actuated by the actuating member to form an incision in skin;

a test strip;

a housing coupled to the test device, wherein the test strip and the housing define a cavity; and

wherein the cartridge has an expression surface configured to express fluid when pressed against skin.

18. The body fluid testing device of claim 17, wherein the housing includes an extension member configured to contact skin; and wherein the incision forming member is at least partially received within the cavity.