JP2004532695A - Apparatus and method for sampling body fluid - Google Patents

Abstract

The system and method for collecting bodily fluid from an incision in the skin includes a sampling device 14 that includes an incision device 14 coupled to the housing 12. The cutting device 14 includes a through portion 18 that extends out of the housing 12 and includes a bent portion, an angled portion, or a beveled portion. The housing 12 and / or the cutting device 14 define a sampling passage 28 adjacent to the insertion portion 18 or having an inlet opening inside the insertion portion. The insertion portion 18 prevents body tissue from clogging the inlet opening 30 and facilitates the collection of bodily fluids at the incision location. In another aspect, the present invention provides a test unit 60 that incorporates the sampling device 10 and that is operable to collect bodily fluids from the incisions and analyze the properties or components of bodily fluids. The invention also includes a method for cutting skin using a sampling device as described and collecting the generated bodily fluid. In a further embodiment, the present invention includes a combination of the above systems and squeezing and / or testing systems and methods with a single integrated device.

Description

【Technical field】
[0001]
[Reference of related application / patent]
This application discloses U.S. Provisional Patent Application No. 60 / 297,098 (1123P) filed on June 8, 2001 and U.S. Provisional Patent Application No. 60 / 324,514 (1127P) filed on September 26, 2001. ) It claims the specification and claims its priority. The aforementioned pending disclosure is incorporated herein by reference.
[0002]
The present invention relates to the sampling of bodily fluids obtained from cuts in the skin, and more particularly to devices and methods utilizing curved, angled or distorted cutting devices to facilitate collection of bodily fluids. The invention also includes a combination of such devices and methods with a display and / or test system.
[Background Art]
[0003]
The acquisition and testing of bodily fluids is useful for many purposes and continues to increase in importance for use in medical diagnostics and therapy, as well as other versatile applications. In the field of medicine, facility operators routinely, quickly and reproducibly perform tests outside of the laboratory settings, produce quick results, and can read the test information that is provided. desired. The test can be performed on a variety of bodily fluids, and for certain applications it is particularly relevant for testing blood and / or interstitial fluid. Such bodily fluids are those in which various properties of the bodily fluid, or analytes contained in the bodily fluid, are tested, such as to confirm a medical condition, determine a therapeutic response, assess the progress of treatment, and the like.
[0004]
Testing a bodily fluid basically involves obtaining a bodily fluid sample, transferring the sample to a test device, performing a test on the bodily fluid sample, and displaying the results. These steps are generally performed by a plurality of separate instruments or devices.
[0005]
One method of obtaining a bodily fluid sample involves inserting a hollow needle or syringe into a blood vessel or artery to withdraw a blood sample. However, there are several limitations to such direct blood sampling, including pain, infection, hematoma, and other bleeding disorders. In addition, direct sampling of vascular blood is not appropriate for routine repetition, can be extremely difficult, and is not recommended for patients to perform on their own.
[0006]
Another common technique for collecting a body fluid sample is to make a cut in the skin to allow the body fluid to exit to the surface of the skin. A lancet, knife or other cutting device is used to make a cut in the skin. The obtained blood or vascular blood is collected in a small tube or other container, or brought into direct contact with the test strip. Fingertips are often used as a source of bodily fluids because of the high concentration of conduits that make good amounts of blood. However, since the nerve terminal is also large at the fingertip and makes a blood vessel, cutting the fingertip can be painful. Other sampling sites, such as palms, forearms, earlobes, etc., are also useful for sampling and are less painful. However, they also produce less blood. Therefore, these separate sites may be used for test systems that require relatively small amounts of fluid, or if steps are taken to facilitate the emergence of fluid from the incised site. It is generally appropriate to use them only in such cases.
[0007]
Various methods and systems for incising the skin are known in the art. Exemplary lance devices include, for example, U.S. Pat. No. 35,803 issued to Lange et al. On May 19, 1998, and U.S. Pat. U.S. Pat. No. 5,879,311 issued to Dunchon et al. On Feb. 16, 1999; U.S. Pat. No. 983, US Pat. No. 6,183,489 issued to Douglas et al. On Feb. 6, 2001, US Pat. No. 6,332,871 issued to Douglas et al. On Dec. 25, 2001, and 1999. U.S. Pat. No. 5,964,718 issued to Dunchon et al. On Oct. 12, 2012 is known. A typical commercial lance butting device is the Acuchek Softclick lancet.
[0008]
Patients are often encouraged to drain body fluid at the incision site, such as by applying pressure to the site surrounding the incision, to draw or pump fluid from the incision site. Mechanical devices are also known that facilitate the appearance of bodily fluids from the incision site. Such devices include, for example, US Pat. No. 5,879,311 issued to Dunchon et al. On Feb. 16, 1999, and US Pat. No. 5,857, issued to Douglas on Jan. 12, 1999. U.S. Pat. No. 6,183,489 issued to Douglas et al. On Feb. 6, 2001; U.S. Pat. No. 5,951,492 issued to Douglas et al. On Sep. 14, 1999; U.S. Pat. No. 5,951,493 issued to Douglas et al. On Sep. 14, 1999; U.S. Pat. No. 5,964,718 issued to Danchon et al. On Oct. 12, 1999; U.S. Patent No. 6,086,545, issued to Lo et al. A typical commercial product that facilitates the emergence of bodily fluids from an incision is the Amira Atrust Blood Glucose System.
[0009]
Obtaining the generated body fluid, hereinafter referred to as "sampling" of the body fluid, can take various forms. As soon as the bodily fluid comes to the surface of the skin by making the cut, the sampling device is brought into contact with the bodily fluid. Such devices include, for example, a system in which a tube or test strip is placed adjacent to the incision site prior to making the incision, or moved to the incision site immediately after the incision is made. Can be included. The sampling tube can obtain body fluids by suction or by capillary action. Such sampling systems include, for example, U.S. Pat. No. 6,048,352 issued to Douglas et al. On Apr. 11, 2000, and U.S. Pat. 099,484, and U.S. Patent No. 6,332,871 issued to Douglas et al. On December 25, 2001. Examples of commercial sampling devices include Roche Compact, Amira Atrast, Glucometer Ellite and Terasense Freestyle specimens.
[0010]
Body fluids are analyzed for various properties and components as is well known in the art. For example, such analysis is directed to hematocrit, blood glucose, coagulation, lead, iron, and the like. The test system includes means such as optical (eg, reflectance, absorbance, fluorescence, Raman, etc.), electrochemical, and magnetic means for analyzing the sampled bodily fluid. Examples of such systems include U.S. Pat. No. 5,824,491 issued to Priest et al. On Oct. 20, 1998, and U.S. Pat. 962,215 and US Pat. No. 5,776,719 issued to Douglas et al. On July 7, 1998.
[0011]
Typically, test systems utilize the reaction of the body fluid to be tested with the auxiliaries contained in the test system. For example, optical test strips generally rely on a color change, i.e., a change in wavelength that is absorbed or reflected by the dye formed by the auxiliary system used. See, for example, U.S. Patent Nos. 3,802,842, 4,061,468, and 4,490,465.
[0012]
A common medical test is the measurement of blood glucose levels. Glucose levels can be measured directly by analysis of blood or indirectly by analysis of other bodily fluids, such as interstitial fluid. Diabetic patients are generally instructed to measure their blood glucose levels several times a day, depending on the nature and intensity of their diabetes. Based on the pattern observed at the measured glucose level, the patient and the physician will determine the appropriate level of insulin to administer, taking into account such issues as diet, exercise and other factors.
[0013]
When testing for the presence of an analyte such as glucose in a body fluid, a test system that utilizes oxidation / reduction generated using oxidase / peroxidase detection chemistry is commonly used. The test aid is exposed to body fluids for a suitable period of time, so discoloration occurs if analyte (glucose) is present. Typically, the magnitude of this change is proportional to the concentration of the analyte therein. The color of the auxiliary is then compared to a known standard so that the amount of analyte therein can be determined. This measurement can be made, for example, by visual check or by an instrument such as a reflectance spectrophotometer or blood glucose meter at a selected wavelength. Electrochemistry and other systems for testing bodily fluids for the properties of components are also well known.
[0014]
The present invention provides for enhancing the sampling of bodily fluids from the incision by forming the incision in a manner that facilitates the collection of bodily fluids, particularly at the site of the incision. The invention further includes the use of a passageway located near the incision to collect bodily fluids.
DISCLOSURE OF THE INVENTION
[0015]
The present invention provides various systems and methods for sampling bodily fluids from an incision in the skin. Sampling is achieved using a notching device with curved, angled or distorted penetrations. The invention encompasses combined systems, including expression and / or test systems, and separate collection devices.
[0016]
In accordance with one aspect of the present invention, there is provided a sampling device including a notching device coupled to a housing. The notching device includes a penetrating portion extending out of the housing and includes a curved, angled or distorted penetrating portion. The housing and / or the scoring device is adjacent to the insertion portion and has a sampling passage therein with an inlet opening. The insertion portion prevents the inlet opening from becoming blocked or clogged by body tissue, and facilitates collection of bodily fluids at the incised site.
[0017]
In another aspect, the invention provides a method for incorporating a sampling device and making a cut in the skin, collecting fluid from the cut, and analyzing the properties or components of the fluid. The invention also includes a method of cutting a skin and collecting a bodily fluid created by using a sampling device as described. In yet another aspect, the invention includes the above systems and methods combined with display and / or test systems and methods, particularly in a single, integrated device.
BEST MODE FOR CARRYING OUT THE INVENTION
[0018]
To facilitate an understanding of the principles of the invention, reference will be made to the embodiments illustrated in the drawings and will be described in a particular language. Nevertheless, it is not intended to limit the scope of the invention, but to such and further modifications of the described apparatus and method, and the principles of the invention as set forth therein. It is to be understood that further applications of the above are considered to normally occur to those skilled in the art to which the invention pertains.
[0019]
The present invention provides various devices and methods that are useful for collecting bodily fluids by making cuts in the skin. The invention is useful for making cuts and for facilitating the collection of bodily fluids at the cut site. As used herein, the term "notch" is intended to refer to an opening in the skin that allows direct access to bodily fluids. The term "cut" is intended to mean making a cut in the skin so that bodily fluids can be directly accessed. The term "notch site" is intended to include a site where a cut is made or made, unless it is clear from the context or obvious language that it is otherwise.
[0020]
The present invention includes a cutting device having an insertion portion, defined as the end of the cutting device that enters the skin during the process of forming a cut in the skin. In accordance with the present invention, the insertion portion is shaped to enhance the collection of bodily fluids at the incision site. In one embodiment, the insertion portion includes a curved or angled component that enters the skin. In another embodiment, the insertion portion is quite straight, but positioned at an angle to the skin, and the straight portion moves along its long axis so that it does not enter the skin. The insertion part is made to enter the skin. The latter embodiment is also referred to herein as a "distorted" penetration. The result in all cases is that the penetrating portion tends to push a portion of the tissue laterally as it continues to move below the skin line. This reduces the pool of bodily fluid at the notch by creating additional space, not occupied by the penetrating portion, for bodily fluid to be collected, especially while the penetrating portion remains below the skin line. Promote.
[0021]
The cutting device is formed with the housing so as to provide a sampling passage on the protected side of the insertion portion. In particular, the cutting device includes an outer portion, defined as the side of the penetration that tends to push the skin away from the cut. For example, for a cutting device having a curved insertion portion, the outer portion is outside the curve. The cutting device also includes an inner portion, defined as the side of the insertion portion opposite the outer portion. The collection passage includes an intake opening located inside the insertion portion of the cutting device. In this way, the intake opening is protected by the penetration when the cutting device is inserted into the skin, thereby preventing the intake opening from being blocked or clogged, and also allowing bodily fluids to pass through the intake opening. Increases the ability to collect at the incision site adjacent to.
[0022]
The length of the insertion portion depends on the desired depth of penetration of the cutting device. This in turn relates to factors such as the location of the fluid sampling, the condition of the skin at that location, and the type of fluid desired for sampling. Therefore, the depth of penetration generally controls the fluid produced, especially in connection with the properties of the incision site. The present invention is useful for various body fluids including blood or interstitial fluid. The cutting device may also be shaped to create either blood or interstitial fluid, for example, by controlling the distance that the cutting device extends into the skin of the user. For example, a depth of 0.25 mm to 4 mm typically creates blood from the dermis, while a depth of 0.05 mm to 0.5 mm typically creates interstitial fluid from the epidermis. Therefore, the length of the insertion portion of the cutting device varies greatly, the preferred length falls in the range of 0.05 mm to 4 mm, and the more preferred length for use in interstitial fluid is 0.05 mm to 0.5 mm. And 0.25 mm to 4 mm for use with blood. Thus, the insertion portion is shaped to provide a non-square portion, ie, a curved, angled or beveled component, within this distance from the tip of the non-cutting device.
[0023]
Referring to the drawings, a first embodiment of the present invention is shown in FIGS. 1-2, which includes a sampling device 10 used to cut a skin and collect body fluid. The sampling device includes a housing 12 and a cutting device 14 coupled to the housing. The cutting device 14 includes an insertion portion 18 extending outward from the housing. The cutting device 14 comprises a lancet 16 including an insertion portion 18 extending outwardly from the housing. The insertion portion includes the insertion end 20 and is curved along its length direction. The insertion portion includes an inner portion 22 and an opposing outer side 24 inside the curved portion. The cutting device further comprises a cylinder 26 defining a passage 28 with an intake opening 30 located on the inner side 22 of the cutting device adjacent the insertion end 20. As previously described, the penetrating portion may instead provide an angle, a curvature and / or a combination of angles, or a non-linear, non-perpendicular configuration as it enters the skin to form a cut. It may be formed in any other form.
[0024]
Sampling device 10 further includes a test strip holder 32 defining an interior chamber 34 for fluid communication with passage 28. The specimen holder also includes an open end 36 into which the specimen 38 (FIG. 3) is inserted. The holder also includes a transparent window 40, or, alternatively, an opening in conjunction with the passage 28 to allow the meter 42 to read the specimen when it is used.
[0025]
The sampling device 10 is used as follows. The housing 12 and the lancet 16 are positioned below the skin 44 in the position shown in FIG. The housing and lancet are then advanced down toward the skin to form cuts 46 in the skin to the desired depth. The penetrating portion is shown in FIG. 4 as including the entire length of the cutting device extending outside the housing, but the penetrating portion may instead include only a portion of this length. This penetration is advanced toward the skin along direction 48 (FIG. 3).
[0026]
As shown in FIG. 4, the curved surface of the lancet 16 tends to push the skin on the outside 24 of the curved surface away from the cut, creating a gap therein in which the bodily fluid 50 can be collected on the inside. The lancet is held in this position within the skin for a short time and the lancet is almost immediately or From It is removed within a very short time, on the order of seconds. Maintaining the lancet in the notch facilitates the collection of bodily fluids. However, the lancet is typically removed relatively quickly to avoid causing undue discomfort to the user.
[0027]
The lancet and the housing are moved away from the skin a sufficient distance to collect bodily fluids in the sampling passage. In one aspect, the lancet is fully spaced from the cut as shown in FIG. As bodily fluid creates a droplet at the cut site, it contacts the inlet opening 30 and is drawn into the sampling passage, such as by capillary action or vacuum. Alternatively, the lancet is partially retracted from the notch to an intermediate position as shown in FIGS. For example, the scoring device may position the inlet opening above, at, or below the skin line. In each case, bodily fluid can be collected at the incision site and then drawn into the sampling passage. The use of a curved insertion section facilitates the collection of bodily fluids and prevents the entrance opening from being blocked or clogged by body tissue.
[0028]
Thereby, bodily fluids can be collected for further use or analysis. In one aspect of the invention, the sampling device operates exclusively as a tool for creating and collecting body fluids. In another aspect, the sampling device is operable to test a property or component of a bodily fluid. For example, as shown in the drawing, bodily fluid received in passageway 28 moves to a test strip 38 located in holder 32 by capillary action or other action. The bodily fluid contacts the underside of the test strip and thereby wets the appropriate test area located in conjunction with the window 40. This test area may consist of chemical auxiliaries read by optical means, electrochemical test systems, or other test systems of a type well known to those skilled in the art. As noted, the test strips include auxiliaries that react with bodily fluids to develop a color or produce other changes read by meter 42. It is therefore understood that the sampling device easily provides a system for creating, collecting and analyzing bodily fluids separately or all in a single, integrated unit.
[0029]
It is a feature of the present invention that the sampling device is useful as an integrated unit that can be discarded after each use. This makes new cutting devices and sampling paths available for each new use. In this regard, the test system may also be provided for disposal with the sampling device. This first embodiment of the sampling device is shown using another test piece received in the holder. However, it should be appreciated that the sampling device may instead include an integrated test area, such as a chemical aid placed directly on the surface of the sampling device. In either approach, the test system is also disposable with the sampling system and is provided in the form of a cartridge that is easily exchanged in a supporting test unit.
[0030]
Referring now to FIGS. 5-8, a test unit useful in combination with the sampling system of FIGS. 1-4 is shown in somewhat schematic form. The test unit 60 includes a body 62, a display 64, at least one button 66 for activating the unit, a calibration interface 68, and the sampling system 10 (FIG. 7). Calibration interface 68 is adapted to receive a device containing information for calibration of test unit 60. For example, the calibration interface 68 is adapted to receive a microchip that contains the constants required for the microchip to be calibrated for a certain number of uses and / or to perform tests on a test unit. I have.
[0031]
Test unit 60 includes conventional means for moving the sampling device forward and backward. For example, the test unit may include a nose cone 70 and a translatable carriage 72 associated therewith. The test unit also includes a carriage and supported sampling between a first, extended position for creating a cut in the human skin and a second retracted position for receiving the bodily fluid collected at the cut. Includes drive and return springs (not shown) that function in a conventional manner to move the device. The function and configuration of such springs and associated mechanisms are well known to those skilled in the art and will not be described further here. Optical housing 74 is coupled to carriage 72 and includes a light source, such as an LED, and a device for receiving light reflected from the test area of the test strip.
[0032]
Test units of the general type described are well known to those skilled in the art. The Odyssey One-Step System of Amira is a commercial example of such a test unit. Specimens of the type described herein are also well known in the art and are disclosed in US Pat. No. 5,968,765 issued to George et al. On Oct. 19, 1999; US Pat. No. 5,876,957 issued to Douglas et al. And US Pat. No. 6,121,011 issued to Duclase et al. On Sep. 19, 2000. . The disclosures of the aforementioned patents are incorporated herein by reference. However, it will be appreciated that the sampling system of the present invention is useful for a wide variety of such test units and systems, and is therefore not limited to a particular unit or system.
[0033]
To use the test unit 60, the test strip 38 is inserted into the holder 32 and the unit is positioned to poke a desired area of skin, such as a fingertip or forearm. The sampling system 10 consisting of the housing 12 and the cutting device 14 is initially in a retracted position with the lancet inside the test unit 60. The lancet is quickly moved into the skin by the drive spring to make a cut. The return spring then retracts the lancet to a desired sampling location within or just above the skin surface. The bodily fluid is thereby received in the sampling passage and travels to the test area for analysis. The test unit may be further activated to display test results to a user.
[0034]
In another aspect, the sampling device 10 includes a remote end surface 76 adapted to be received against a surface portion 78 of the nose cone 70. This represents the extended position of the sampling device for the creation of the cut, and the surface portion 78 acts as a hard stop for the forward movement of the sampling device. This reduces the pain associated with the procedure by providing a hard stop. This is because the patient's skin is not used to stop the advancement of the needle. In addition, since the hard stop controls the forward movement of the sampling device, a drive spring with a larger force constant may be utilized that drives the spring into the patient's skin at a higher speed.
[0035]
Referring to FIG. 9, another embodiment of the sampling device of the present invention is shown. The sampling device 80 includes a housing 82 and a cutting device 84. However, compared to the previous embodiment, the sampling device 80 also includes a tube 86 defining a sampling passage 88 with an inlet opening 90 on the interior side 92 of the cutting device. Sampling device 80 may be otherwise configured to function in the manner described with respect to the embodiment of FIG.
[0036]
In another embodiment of the present invention, the sampling device includes an oblique cutting device. As shown in FIG. 10, by moving the straight insertion portion at an angle to the long axis of the insertion portion toward the skin, the provision of an oblique cutting device can be achieved in a single approach. The sampling device 100 is similar to the embodiment of FIG. 9 except that the cutting device 102 includes a straight insertion portion 104. Further, the sampling device is positioned at an angle to the skin surface 106 and is at right angles to the skin surface and is angled or oblique relative to the long axis 110 of the penetrating portion 104. Moving along the direction 108 toward the skin. This direction of movement is similar in that the outer side 112 encounters the skin tissue and pushes it aside as the insertion portion forms the cut, which has a similar function to that obtained in the non-linear portion of FIG. This is apparent from FIG. Furthermore, the inlet opening 114 of the sampling passage 116 is protected by being arranged on the inner side 118 of the insertion part. This embodiment of FIG. 10 further contemplates the use of a more standardized version of the present invention, but which may be beveled, poked, or otherwise cut when applied to the skin to make a cut. It represents that it is.
[0037]
A second alternative skewed insertion section is shown in FIG. 11, where the sampling device 130 includes a housing 132 and a cutting device 134 that includes a straight insertion portion 136. However, the straight insertion portion 136 extends outwardly from the housing 132 at an angle to the housing centerline 138 and with an axis of travel 140 relative to the housing relative to the skin surface 142. The sampling device further includes a tube 144, a sampling passage 146, and an inlet opening 148. In this embodiment, the scoring device and tube are shown as being completely straight and extending at an angle within housing 132. However, it will be appreciated that the scoring device and / or tube need not be perfectly straight and may therefore be oriented differently within the housing.
[0038]
The sampling device 130 is used by pushing the penetrating portion 136 against the skin 142 along the direction of the movement 140, which is different from the long axis of the penetrating portion. The result is the same as in the previous embodiment, since the penetration protects the entry opening from the skin tissue and facilitates the collection of bodily fluids at the incision site.
[0039]
In the above embodiments, the sampling passage may be formed as part of a hollow needle or other cutting device, or separate therefrom. For example, the previous embodiment of FIGS. 10 and 11 is shown with separate cutting devices and capillaries defining a sampling passage. Alternatively, the housing may define a sampling passage without the use of a capillary, such as by a passage formed directly in the housing. In addition, the cutting device may instead consist of a hollow element that includes a through end and defines a sampling path, for example, as shown in the embodiment of FIG.
[0040]
It will be appreciated from the foregoing description that some forms of sampling system comprising the present invention are useful independently of the presence or type of expression and / or test system. However, in some embodiments, the sampling mechanism and method are coupled to a representation and / or test system. It will be recognized by those skilled in the art that the function of the sampling system is achieved independently of these other systems, and is therefore useful with various systems as known to those skilled in the art. Will. However, it is advantageous that the sampling system be combined with other systems in a single, integrated device and described in the invention described in the section of the prior art and in the patents identified elsewhere. The disclosure of such patents is hereby incorporated by reference as it would be useful in combination with a wide range of incision, representation and testing systems, including those.
[0041]
As shown in the drawings, such an integrated device preferably operates such that it must be relocated at any time during the cutting, rendering, sampling and testing system process. More particularly, the device preferably performs a cutting, rendering, sampling and testing system to provide complete, integrated monitoring of bodily fluids. In accordance with this approach, the device is moved relative to the skin and maintained in this position while the incision is formed, and also while the resulting drops of bodily fluid exit and are carried into the sampling device. The body fluid is then analyzed by the test system and the results of the analysis are provided to the user. Therefore, all of these operations can be accomplished by a single, integrated unit, providing a simple, fast and reliable way to collect and test body fluids.
[0042]
Although the invention has been illustrated and described in detail in the drawings and foregoing description, it is to be understood that this is illustrative and that the nature of the invention is not intended to be limiting; It should be understood that is shown and described, and that all changes and modifications that come within the spirit of the invention are desired to be protected.
[Brief description of the drawings]
[0043]
FIG. 1 is a side cross-sectional view of a sampling device constructed in accordance with one embodiment of the present invention.
FIG. 2 is a partial front plan view of the sampling device of FIG. 1, showing details of an end of the scoring device.
FIG. 3 is a side cross-sectional view of the sampling device of FIG. 1 positioned adjacent to the skin.
FIG. 4 is a side cross-sectional view of the sampling device of FIG. 1 being received in the skin and forming a cut in the skin.
FIG. 5 is a front elevation view of a useful test apparatus in accordance with the present invention.
FIG. 6 is a lateral front elevation view of the test apparatus of FIG. 5;
FIG. 7 is a front and side cross-sectional view of the test apparatus of FIG. 5, particularly showing the reception of the sampling apparatus therein.
FIG. 8 is a front and side cross-sectional view of the test apparatus of FIG. 5, particularly showing the reception of the sampling apparatus therein.
FIG. 9 is a side cross-sectional view of another embodiment of the sampling device of the present invention.
FIG. 10 is a side cross-sectional view of another embodiment of the sampling device of the present invention, showing a distorted insertion portion for the notch forming device.
FIG. 11 is a side cross-sectional view of another embodiment of the sampling device of the present invention having a distorted insertion portion.

Claims (26)

A housing,
A cutting device coupled to the housing, the cutting device including an insertion portion having an insertion end, the insertion portion having an inner side and an outer side, and the outer side between the insertion portion into the skin. Is shaped to include a non-perpendicular portion with respect to the skin, and at least one of the housing and the cutting device defines a sampling passage having an inlet opening on an interior side of the insertion portion adjacent the insertion end. Cutting device,
A sampling device for collecting body fluid from a cut in the skin, comprising: The sampling device according to claim 1, wherein the sampling passage is a capillary passage. The sampling device according to claim 1, further comprising a test system connected to the cutting device in fluid communication with the sampling passage. The sampling device according to claim 3, wherein the test system comprises a test piece. 4. The sampling device of claim 3, wherein the test system is associated with a single, disposable unit. 2. A sampling device according to claim 1, wherein said cutting device comprises a curved, hollow needle defining a sampling passage. The sampling device of claim 1 wherein said cutting device comprises a hollow angled needle and defines a sampling passage. The sampling device of claim 1, wherein the housing defines a sampling passage remote from the cutting device. 9. The sampling device of claim 8, wherein said housing is mounted within said housing to define a sampling passage. A system housing,
A sampling device including a cartridge housing and a cutting device connected to the cartridge housing, wherein the cutting device includes an insertion portion having an insertion end, the insertion portion has an inner side and an outer side, and the outer side has an insertion portion. During insertion into the skin, the cartridge housing and at least one of the cutting devices are configured to include an inlet opening at an interior side of the insertion portion adjacent the insertion end. Wherein the sampling device is attached to the system housing and receives a first extended position for creating a cut into the human skin and a bodily fluid collected at the cut. With a second retracted position for
A sampling device for collecting body fluid from an incision in the skin. The sampling system of claim 10, further comprising means for moving the sampling device between a first and a second position. The sampling device according to claim 10, wherein the sampling passage is a capillary passage. 11. The sampling device of claim 10, further comprising a test system in fluid communication with the sampling passage and connected to the cutting device. 14. The sampling device according to claim 13, wherein the test system comprises a test piece. 14. The sampling device of claim 13, wherein the test system is associated with a single, disposable unit. 11. The sampling device of claim 10, wherein the cutting device comprises a curved, hollow needle defining a sampling passage. 11. The sampling device of claim 10, wherein the cutting device comprises an angled hollow needle and defines a sampling passage. The sampling device of claim 10, wherein the cartridge housing defines a sampling passage remote from the cutting device. 19. The sampling device of claim 18, wherein said cartridge housing includes a capillary mounted within said housing and defines a sampling passage. Between a sampling device including a housing and a cutting device connected to the housing, a cutting device including an insertion portion having an insertion end, an insertion portion having an inner side and an outer side, and insertion of the insertion portion into the skin. The outer side, which is shaped to include a non-perpendicular portion with respect to the skin, at least one of the housing and the cutting device defines a sampling passage having an inlet opening on the inner side of the insertion portion adjacent the insertion end. What was established,
From advancing the sampling device against the skin to penetrate the skin at the penetration of the cutting device, and maintaining the cutting device adjacent to the skin to collect bodily fluids from the cut into the sampling passage through the inlet opening; A method of collecting body fluid from a cut in the skin. 21. The method of claim 20, further comprising providing a vacuum into the sampling passage to draw body fluid through the inlet opening. 21. The method of claim 20, wherein the sampling passage comprises a capillary passage, and wherein bodily fluid is drawn into the sampling passage through the inlet opening by capillary action. 21. The method of claim 20, further comprising testing the collected bodily fluid. 21. The method of claim 20, wherein the insertion portion is curved. 21. The method of claim 20, wherein the piercing portion is straight and the advancing comprises advancing the piercing portion at a non-perpendicular angle with respect to the skin. 21. The method of claim 20, wherein the cutting device is a hollow needle.