Abstract: A blood lancet is disclosed that has a base; a needle mounted to the base; a cap that slides relative to the base, and a locking member located inside between the base and cap. In use, the base and cap are initially at an expanded position and the needle is retracted below a hole in the cap. When the user is ready to draw a blood sample, the user positions a finger on the cap and squeezes the base and cap together. The locking member initially resists the movement of the cap until sufficient force is applied to snap the locking member into the cap, which permits the cap to quickly retract to expose the needle and prick the user's finger. This movement also spreads apart two cantilever springs that bias the cap back toward the initial expanded position. When the user stops squeezing the base and cap together, the springs push the cap and the locking member, which is now engaging the cap, to the expanded position.

Abstract: A lancet depth adjustment assembly structured to be used use with a lancet device of the type including a lancet disposed movably within a housing so as to pass into a piercing orientation wherein a piercing tip of the lancet protrudes from a piercing aperture defined in the housing. The lancet depth adjustment assembly includes a depth adjustment element movably secured in overlying relation to the piercing aperture of the housing and having a piercing access structured to permit passage of the piercing tip of the lancet therethrough. The depth adjustment element is structured to be interposed between a finger of a patient and the piercing aperture so as to define a spacing therebetween, and accordingly define a depth to which the piercing tip, which protrudes a defined amount from the housing, penetrates the body part.

Abstract: The apparatus includes a single-use compartment assembly which includes a reservoir for blood and a needle element by which blood is obtained from the user. A vacuum system is actuated which draws blood through the needle element into the blood reservoir. An ultrasound signal is directed through the reservoir. There is no return ultrasound signal until there is sufficient blood in the reservoir. When the blood reaches a given level, it contacts a clotting agent present in the reservoir to begin the clotting process. The ultrasound signals are transmitted and return until clotting has been completed, as determined by a pre-established increase in the two-way propagation time relative to unclotted blood. The prothrombin time is then calculated and compared with an acceptable range.

Abstract: The invention describes an analytical device (1) which is suitable for collecting and examining body fluids and in particular blood. The analytical device (1) contains a test element (2) and a lancet (3) whereby the test element (2) contains the following components: 1.) a frame element (7), and 2.) at least one detection element (6) which can also be multilayered and can contain among others an erythrocyte separation layer, a spreading layer and an optical barrier layer which is directly or indirectly connected to the frame element (7) and the lancet (3) contains the following components: 1.) a needle (11) with a tip (23) and 2.) a lancet body (10) which at least partially surrounds the needle (11). The inventive device (1) is characterized in that the lancet body (10) is movably connected to the frame element (7) of the test element (2) i.e.

Abstract: A trocar useful for forming an incision in a target vessel for placement of an anastomosis device which may have an inner flange formed by radial expansion of the device and an outer flange formed by axial compression of the device. The trocar can have a smaller size during formation of the incision and a larger size when retracted over a deployment tool used to deploy the anastomosis device.

Abstract: Blood lancet system for blood withdrawal for diagnostic purposes with a housing, a lancet holder movable in the housing for holding an exchangeable lancet, and a lancet drive for driving the pricking movement of the lancet holder with the lancet contained herein. The housing has a cap at the front end in pricking direction which can be removed in order to remove a used lancet from the lancet holder.

Abstract: It has been discovered that the use of a substantially free-standing voice coil within a lancing device in coordination and combination with a stationary magnet and electronic circuit renders a much improved lancing device. The minimal weight of the free standing voice coil and the attractive forces of the magnet allow the battery-powered electronic circuit to maintain excellent control over the advancement and retraction of a lancet. When the electronic lancing device is initiated by a user, the voltage source within the electronic lancing device provides sufficient current through the voice coil such that the coil and lancet are repulsed from the magnet and propelled into the puncture site.

Abstract: A device for sampling blood from the skin of a patient by puncture. The device includes one or more lancets for lancing the skin and a fluid-conducting plate unit for transporting blood from the lancing wound. The plate unit has one or more channels for conducting fluid to one or more target locations. Preferably there is a first channel for conducting away a first portion of fluid that contains more of a fluid that is emitted initially (initial fluid) from the puncture wound and a second channel for conducting a second portion of fluid that contains less of the initial fluid from the puncture wound. Blood is drawn into the channels by capillary force. The device can be used to lance the skin and obtain a representative sample of blood with relatively simple procedures.

Abstract: The present invention provides a hollow tubular shaped biopsy needle having a hollow elliptical cross section shaped lumen therethrough, and the method for fabricating the needle and the apparatus for operating the needle. The structure of the biopsy needle of this invention is simple and easy to fabricate, and thus the production cost can be reduced. In comparison of the smaller diameter of this invented biopsy needle to the diameter of the other biopsy needles, the size of the extracted sample will be bigger and wounds of the patient can be less. The apparatus of this invention will help to reduce the operating force during extracting tissue samples, and helps rotation and straight movements of the needle.

Abstract: Three embodiments of a single-step lancet are disclosed. Each such lancet embodiment provides true one-step operation. In a single operational step requiring only a unidirectional displacement of an actuator into a housing, a lancet blade is removed from an aseptic environment which protects and retains the lancet blade in a pre-sterilized state within the housing prior to use, stores energy in an energy storage medium, activates the lancet blade to perform a lance and for safety retracts the lancet blade into the housing.

Abstract: A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and/or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: A cap for a lancing device for lancing dermal tissue is provided. The cap includes a cap body having a proximal end for connecting to the distal end of the housing of the lancing device and a contact ring attached to the distal end of the cap body. The contact ring includes an opening for a portion of the lancet of the lancing device to pass therethrough. The contact ring has a multi-contoured surface oriented generally about an axis distinct from the axis of motion of the lancet. The multi-contoured surface is designed to pressure the dermal tissue to facilitate expression of a fluid sample after lancing the dermal tissue. The fluid sample can include blood, interstitial fluid, or both.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

Abstract: A lancet depth adjustment assembly structured to be used use with a lancet device of the type including a lancet disposed movably within a housing so as to pass into a piercing orientation wherein a piercing tip of the lancet protrudes from a piercing aperture defined in the housing. The lancet depth adjustment assembly includes a depth adjustment element movably secured in overlying relation to the piercing aperture of the housing and having a piercing access structured to permit passage of the piercing tip of the lancet therethrough. The depth adjustment element is structured to be interposed between a finger of a patient and the piercing aperture so as to define a spacing therebetween, and accordingly define a depth to which the piercing tip, which protrudes a defined amount from the housing, penetrates the body part.

Abstract: A disposable lancet for puncturing skin is disclosed herein. The lancet comprises a T-shaped housing, a reciprocally movable elongated body that embeds a puncturing needle and a leaf spring to bias the elongated body towards a safe neutral position, where the puncturing device is retracted in the housing. The elongated body is generally cross-shaped and is guided by projections in the housing that define a cross-shaped passage. The leaf spring is located in the handle portion of the T-shaped housing and cooperates with the elongated body via a slit provided in the elongated body. The lancet is operated by pressing a portion of the elongated body that extends from the handle portion of the housing at one end. The lancet is then in a puncturing position, where the puncturing needle extends out of the housing at the distal end thereof. The elongated body returns to the safe neutral position when the force applied to the elongated body is no longer sufficient to overcome the biasing action of the leaf spring.

Abstract: A disposable body fluid or tissue collection vial is disclosed. The vial has a sample accessing tool and a sample delivery member for dispensing a sample of body fluid or tissue into a reagent. The vial also has a base, a sample delivery sleeve, a sample accessing sleeve, and a cap. The sample delivery sleeve detachably attaches to the base, the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve. The base may contain one or more reagents suitable for diagnostic or other uses.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: A reusable ceramic skin-piercing device. The skin-piercing device is capable of piercing the skin so as to make a sample of biological fluid available for an assay. In one embodiment, the skin-piercing device includes a skin-piercing element which is heated prior to use to a sufficiently high temperature to kill or deactivate pathogenic microorganisms. The device is heat-sterilized, being heated by passing an electrical current through a resistive element in thermal contact with the heat-conducting ceramic piercer. In another embodiment, the skin-piercing device includes a sleeve of elastomeric material with a sterilizing agent disposed in contact with the skin-piercing element. The sterilizing agent sterilizes the skin-piercing element after use.

Abstract: An assembly to be detachably mounted on a body fluid monitoring system is provided. The assembly has a lancet and a device for collecting and detecting a body fluid. The lancet has a puncture needle. In this assembly, the puncture needle is maintained in sterilized conditions until its use, and the sterilization can be conducted with no adverse effects on the detection device. A readily sterilizable lancet unit and a body fluid-collecting and detecting unit adapted for use in such an assembly as well as a body fluid-monitoring system including such an assembly are also provided. The assembly comprises a first housing having a sleeve which movably accommodates the lancet in its interior, and a second housing having the body fluid detection device. The first housing and the second housing share an opening. The lancet is sterilized before the assembly. The body fluid-collecting and detecting section has a body fluid guide on the periphery of the inlet.

Abstract: An arrangement for regulating the depth of a puncture including a sleeve, a button placed at one end of the sleeve, a piston with a puncturing tip that is slidably mounted within the sleeve, and a power spring placed between the front of the button and the piston. The other end of the sleeve (1) includes an adjusting ring (3), which has two inwardly directed half-ringed, oblique limiting members (14, 15), which are hit by fin (7) of the piston during puncturing of skin.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Abstract: A body-fluid inspection device, which sticks a skin so as to obtain a fine amount of body fluids and measures ingredients of the body fluids, includes a casing having an opening, a sticking device having a sticking needle that is allowed to protrude from the opening of the casing, and a suction device which places at least portion of a space inside the casing in a reduced-pressure state. Also included are a reduced-pressure releasing device for releasing the space inside the casing from the reduced-pressure state, a chip which is detachably attached to the opening of the casing and is provided with test paper for absorbing the body fluids that have been sucked by the body-fluid suction device, a measuring device for measuring ingredients of the body fluids that have been absorbed by the test paper, and a display device for displaying results of measurements made by the measuring device. The display device is placed on one portion of a surface of the casing.

Abstract: A single use lancet device having a housing, with an open interior and an access opening defined therein, a lancet, with a body and a piercing tip, and disposed in the open interior of the housing so as to move between a cocked orientation and a piercing orientation, a driving assembly structured to move the lancet into the piercing orientation, and a restrictor assembly having a shoulder element and a restrictor panel operatively associated with the lancet and the housing and structured to pass over the restrictor panel upon the lancet moving from its cocked orientation to its piercing orientation, and to abut the restrictor panel upon attempted movement of the lancet back into its cocked orientation after movement into the piercing orientation, thereby preventing the lancet from moving back into the cocked orientation and preventing re-use of a contaminated piercing tip.

Abstract: An apparatus and method for minimizing a subject's pain perception during an invasive medical procedure, such as blood sampling and the like. The apparatus can include a receiving surface constructed to contact a portion of the subject's skin and a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject's skin. An invasive sharp can be substantially permanently supported and moveably disposed with respect to the receiving surface such that the invasive sharp reciprocates between a first position in which the sharp is spaced from the receiving surface, away from the subject's skin, and a second position in which at least a portion of the sharp protrudes through an opening in the receiving surface.

Abstract: A device for making an incision in skin, having a housing with a slotted opening, and a triggering mechanism disposed within the housing for propelling a blade coupled thereto, through the slotted opening of the housing to make an incision in the skin. The triggering mechanism includes a finger engageable trigger located external to the housing for actuating the triggering mechanism and a spring anchoring assembly for automated machine arming the device after the triggering mechanism has been assembled into the housing.

Abstract: Cutting device for skin for obtaining small blood samples from human or animal tissue in an almost pain-free manner. A blade (13) is made to oscillate by an oscillator (14, 32) and is lowered into the tissue and again retracted at a relatively slow speed. In a first embodiment, the blade oscillates essentially parallel to the cutting edge of the blade and the tissue surface. In a second embodiment, the blade oscillates essentially perpendicular to the tissue surface. An advantage of the device of the invention is the reduced pain during pricking.

Abstract: A technique for efficiently sampling blood from body tissue by reducing pressure on the body tissue. In the present technique a body tissue is placed under reduced pressure to improve perfusion of blood in the body tissue before lancing. An embodiment of this apparatus includes a lancet carried by a piston slidable in a housing, a mechanism for transmitting mechanical energy internally in the apparatus for creating the reduced pressure on the body tissue. The apparatus also includes a driver that drives the lancet for lancing. The apparatus has a head in the housing for contacting the body tissue in an air-tight manner against suction forces. In the head facing the body tissue is a channel in which the air pressure can be reduced.

Abstract: A lancet device used to pierce a user's skin and including a lancet with a body portion and a piercing tip, a primary housing, a cover assembly with a piercing opening and structured to be matingly coupled with the primary housing to define an interior chamber, and a lancet receiving assembly movably disposed within the interior chamber and structured and disposed to hold the lancet during its driven movement between a cocked orientation, a piercing orientation and a fired orientation.

Abstract: A disposable lancing element is adapted for use in a lancing device for making an incision through a user's skin. The lancing element includes a body which defines a longitudinal axis, and has a skin-lancing member projecting from a front end thereof. A capillary tube is mounted in the body in laterally spaced relationship to the skin-lancing member and is slidable longitudinally relative to the body so as to be extended forwardly past the skin-lancing member. The body includes a plurality of circumferentially spaced, radially outwardly projecting bosses formed thereon for guiding the disposable element installation in a carrier element. The skin-lancing member may comprise a plurality of needles or barbs arranged in parallel side-by-side relationship. In lieu of a skin-lancing member, the disposable element may possess a longitudinal through-hole for conducting a skin-piercing laser light beam or pressurized fluid. A capillary tube may have an outwardly flared lower (inlet) end.

Abstract: A multi-shaft apparatus for incising a substrate of soft resilient material such as a body tissue. The incising apparatus includes two or more incision shafts each having a distal edge. The shafts are not affixed to each other and are allowed to slide against each other to drive the distal edges alternately against the substrate to incise the substrate. In the case of incising a body tissue, such alternate motion would result in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts.

Abstract: A multi-shaft apparatus for incising a substrate of soft resilient material such as a body tissue. The incising apparatus includes two or more incision shafts each having a distal edge. The shafts are not affixed to each other and are allowed to slide against each other to drive the distal edges alternately against the substrate to incise the substrate. In the case of incising a body tissue, such alternate motion would result in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts.

Abstract: A single-use, spring driven lancet is described. The device is precooked during assembly so that the user needs only to remove the safety cap prior to use. A concave trigger button with direct up and down motion releases the spring, causing the tip of the lancet to strike the subject's finger. A thin plastic fiber connection between the pull-tab and the needle safety cap prevents any compressive force from being applied to the drive spring, which effectively prevents recocking of the device.

Abstract: Lancet device having an adjustable penetration depth. The lancet device includes a housing, a cap for covering the housing and for positioning the lancet device relative to a skin surface, a needle holding member for holding a lancet which needle holding member is at least partially contained within the housing, a biasing element for biasing the needle holding member toward an extended position, and a trigger for releasing the needle holding member from a retracted position. The lancet device further includes a mechanism for adjusting a penetration depth of a lancet. The penetration depth adjustment mechanism may involve adjusting a travel distance of the needle holding member, wherein the mechanism is positioned within at least one of the housing and the cap during at least a portion of length of travel of the needle holding member. The penetration depth adjustment mechanism may involve adjusting a travel distance of the needle holding member by adjusting a length of the needle holding member.

Abstract: A lancet device for lancing skin with a lancing needle of a lancet. The lancet device includes a housing and a lancet holder within the housing which is engageable with the lancet and moveable along a longitudinal axis of the housing. The device also includes a cam which has an end surface engageable with the lancet holder, cocking structure, biasing means between the cocking structure and the cam, and a trigger which is engageable with the cam for preventing rotation of the cam during actuation of the cocking structure. Actuation of the cocking structure causes the biasing means to become loaded between the cam and cocking structure, wherein upon disengagement of the trigger from the cam, the cam rotates, causing the lancet holder to move generally along the longitudinal axis of the housing. The lancet holder includes a cam follower member which contacts the end surface of the cam. The cam follower member rides along the end surface of the cam when the cam rotates in the housing.

Abstract: A vacuum assisted lancing device (10) for obtaining capillary blood from body sites includes a plunger (12) mounted in a barrel or upper housing (24) that upon being pressed by a user, drives a lancet (18) to puncture skin at a body site. A vacuum member such as a diaphragm (38, 66) or bellows (66) is displaced by the plunger (12) and displaces air in the lancing device (10) to create a vacuum. The vacuum draws skin partially into the lancing device (10) causing blood to form at the puncture. The vacuum is then released and the blood is tested.

Abstract: After removal of a protective cap, the forward end of a barrel (1) of a skin pricker is placed against the skin and the user presses the projecting end of a trigger (6) forwards. As the trigger pivots about a fulcrum (9) of the barrel (1), a thin bridge onto a lancet (2) shears. The lancet is released, and shoots forward as a spring (3) extends, thus projecting a needle tip (4) to prick the skin. This projection is only momentary and the lancet (2), which is captive to the spring (3), is pulled back as the spring (3) reverts to a recovery position where the needle tip is safe inside the barrel. The trigger (6), although broken away from the lancet, remains captive to the barrel by the enlargement (11). The lancet cannot again be operated to eject the needle and the pricker is then intended to be discarded.

Abstract: A multi-shaft apparatus for incising a substrate of soft resilient material such as a body tissue. The incising apparatus includes two or more incision shafts each having a distal edge. The shafts are not affixed to each other and are allowed to slide against each other to drive the distal edges alternately against the substrate to incise the substrate. In the case of incising a body tissue, such alternate motion would result in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts.

Abstract: A lancet device has a two part housing (1) integrally molded in a folded-out configuration with a spring (2), a lancet body (3) encasing a needle (4), and a needle cap (5) concealing the needle tip. The spring (2) is a zig-zag connected at one end to one housing part (7) by a web (19) and merging at the other end into the lancet body (3). This is folded over with the spring (2) about the web (19) into the housing part (7), and the other housing part (6) is closer over about web hinges (8) and fastened. A trigger (9) is incorporated in the other housing part (6) and is deformable inwardly to release the lancet body (3) from a catch arrangement (14, 21) which holds the lancet retracted with the spring energized. The needle cap (5) can be used for the retraction before being removed.

Abstract: A device for sampling blood from the skin of a patient by puncture. The device includes one or more lancets for lancing the skin and a fluid-conducting plate unit for transporting blood from the lancing wound. The plate unit has one or more channels for conducting fluid to one or more target locations. Preferably there is a first channel for conducting away a first portion of fluid that contains more of a fluid that is emitted initially (initial fluid) from the puncture wound and a second channel for conducting a second portion of fluid that contains less of the initial fluid from the puncture wound. Blood is drawn into the channels by capillary force. The device can be used to lance the skin and obtain a representative sample of blood with relatively simple procedures.

Abstract: Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: A skin pricker includes a barrel and a spring loaded lancet which can be primed and then fired, momentarily to project its tip. A finger projects laterally from the lancet through a slot in the barrel and this finger is pulled back past a catch to prime the device. A weak connection between the finger and lancet allows the finger to be bent until that connection breaks, thus firing the lancet. The finger may remain captive to the barrel.

Abstract: A lancet and method of manufacture. The lancet comprises a wire sandwiched between an upper web and a lower web. A twist-off wire point cover is provided to protect the point of the wire, and to preserve its sterility until use. The method of manufacture includes the steps of heating the upper and lower webs, thermoforming a lower web wire groove and a lower web wire point recess into the lower web, loading a wire into the lower web wire groove such that its point is disposed within the lower web wire point recess, gluing the upper web to the lower web at a lidding station, and cutting twist-off slits into the upper and lower webs to provide the twist-off cover. Alternate embodiments of the lancet are disclosed which provide a lancet containing a valley to facilitate wire loading, and which provide finger grips on the upper and lower webs. A butterfly and method of manufacture are also disclosed.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.It has also been discovered that an improved design and construction of the nosepiece can provide enhanced collection of blood from the unobstructed opening in the skin.

Abstract: A cartridge for sampling and analyzing blood from the skin of a patient. The cartridge has a cartridge case, a lancet, and associated with the cartridge case an analytical region for analyzing the property of blood. The lancet has a tip for lancing the skin and is housed in the cartridge case. The lancet is operatively connected to the cartridge case such that the lancet can be pushed to extend its tip outside the cartridge case for lancing the skin to yield blood. The blood from the lancing wound is transferred to the analytical region and be analyzed.

Abstract: Body fluid is sampled from a skin incision by placing a ring against the skin and repeatedly applying an elastic pressing force to the ring, whereby a stimulator surface of the ring depresses a ring of skin and body tissue in surrounding relationship to the incision to force body fluid from the incision. The stimulator surface is inclined at an angle of 10 to 65 degrees; a width of the stimulator surface is from 5 mm to 20 mm, and an inner diameter of the stimulator surface is no less than 6.0 mm.