US20010031931A1 - Method and apparatus for obtaining blood for diagnostic tests - Google Patents
Method and apparatus for obtaining blood for diagnostic tests Download PDFInfo
- Publication number
- US20010031931A1 US20010031931A1 US09/532,729 US53272900A US2001031931A1 US 20010031931 A1 US20010031931 A1 US 20010031931A1 US 53272900 A US53272900 A US 53272900A US 2001031931 A1 US2001031931 A1 US 2001031931A1
- Authority
- US
- United States
- Prior art keywords
- blood
- skin
- sample
- vacuum
- extracted
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150221—Valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150229—Pumps for assisting the blood sampling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15134—Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
- A61B5/15136—Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids by use of radiation, e.g. laser
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.
Description
- 1. Field of the Invention
- This invention relates to a method and apparatus for obtaining samples of blood for diagnostic purposes.
- 2. Discussion of the Art
- The prevalence of diabetes has been increasing markedly in the world. At this time, diagnosed diabetics represented about 3% of the population of the United States. It is believed that the total actual number of diabetics in the United States is over 16,000,000. Diabetes can lead to numerous complications, such as, for example, retinopathy, nephropathy, and neuropathy.
- The most important factor for reducing diabetes-associated complications is the maintenance of an appropriate level of glucose in the blood stream. The maintenance of the appropriate level of glucose in the blood stream may prevent and even reverse many of the effects of diabetes.
- Glucose monitoring devices of the prior art have operated on the principle of taking blood from an individual by a variety of methods, such as by needle or lancet. An individual then coats a paper strip carrying chemistry with the blood, and finally insert the blood-coated strip into a blood glucose meter for measurement of glucose concentration by determination of change in reflectance.
- The medical apparatus of the prior art for monitoring the level of glucose in the blood stream required that an individual have separately available a needle or lancet for extracting blood from the individual, strips carrying blood chemistry for creating a chemical reaction with respect to the glucose in the blood stream and changing color, and a blood glucose meter for reading the change in color indicating the level of glucose in the blood stream. The level of blood glucose, when measured by a glucose meter, is read from a strip carrying the blood chemistry through the well-known process of reading reflectometers for glucose oxidation.
- Generally lancets comprise a blade and a pressable end opposed thereto, with the blade having an acute end capable of being thrust into skin of a human. By striking the pressable portion, the acute end of the blade will pierce the skin, for example, of the finger. The finger lancet is primarily used to obtain small volumes of blood, i.e., less than 1 mL. Diabetics use the finger lancet to obtain volumes of blood less than 25 μL for analysis for glucose. A small amount of blood for the blood test will ooze out of the skin. There are many small blood vessels in each finger so that a finger can be squeezed to cause a larger drop of blood to ooze. The finger is one of the most sensitive parts of the body; accordingly, the finger lancet leads to even more pain than what would be experienced by extracting blood via lancet at a different body site. The finger lancet presents another problem because of the limited area available on the fingers for lancing. Because it is recommended that diabetics monitor their blood glucose levels four to six times per day, the limited area on the fingers calls for repeated lancing of areas that are already sore. Because fingers are sensitive to pain, it is a recent tendency that the arm is subjected to blood sampling. See, for example, U.S. Pat. No. 4,653,513. The device of U.S. Pat. No. 4,653,513 comprises a cylindrical housing and a lancet support, which has a gasket or flexible portion slidably accommodated in the housing. Springs will retract the lancet support to thereby reduce air pressure in the housing so that it sucks a blood sample, automatically and immediately after a lancet pierces the skin. See also U.S. Pat. No. 5,320,607, which discloses a device comprising a sealed vacuum chamber in a state of preexisting reduced pressure, a support member for the sealed vacuum chamber, the support member defining a suction portion adjacent the sealed vacuum chamber, the suction portion, in cooperation with the sealed vacuum chamber, exposing an area of the skin of a patient to a reduced pressure state when the device is actuated, and means arranged within the suction portion for slightly rupturing a portion of the area of skin of the patient exposed to the reduced pressure state.
- Because the blood volume requirements for a standard glucose test strip is typically 3 μL or more, an area of the body that can generate that much blood from a lancet wound must be used. It is believed, however, that improvements in glucose test strip technology will reduce the volume of blood needed to 1 to 3 μL. Because the finger is well supplied with blood and the amount of blood can be increased by squeezing the finger after lancing, the finger is the currently preferred body site for lancing, even though lancing of the finger is painful.
- A less painful technique for obtaining body fluids could be found if a reliable method were found for lancing a body part that is less sensitive to pain than the finger and obtaining a useful amount of blood from that body part. A body part such as the forearm is much less sensitive to pain than the finger, but the amount of blood resulting from the lancing procedure is generally of an inadequate volume for use with current detection technology. Ways of increasing blood flow to the finger are common knowledge. The recommendation is made to diabetics to run their finger under hot water prior to lancing to improve the blood flow in the finger and the amount of blood collected from the finger. Running hot water over a body part to improve blood flow is impractical for areas such as the forearm or thigh. The availability of hot water is also a concern.
- It would be desirable to develop a technique and apparatus for obtaining blood for diagnostic purposes in a painless, reliable manner.
- This invention provides a method and apparatus for extracting 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 vacuum and stretching of the skin.
- In a preferred embodiment of the method, step (a) is preceded by the step of increasing the availability of blood in the portion of the skin from which the sample is to be extracted. In this preferred embodiment, the availability of blood in the portion of the skin from which the sample is to be extracted can be increased by means of a vacuum, which is applied to the surface of the skin in the vicinity of the opening prior to forming the opening in the skin. The vacuum causes the portion of the skin in the vicinity of the blood extraction site to become engorged with blood. The vacuum also causes the portion of the skin in the vicinity of the blood extraction site to become stretched. An opening in this stretched portion of skin can be formed with a cutting or puncturing device, e.g., a lancet, or other device capable of forming an opening in the skin, e.g., a laser or a fluid jet. If a cutting or puncturing device is used to form the opening, it must be retracted from the opening prior to the step of extracting the sample of blood from the opening. This retraction will allow the unrestricted flow of blood through the opening. After the opening is formed, a vacuum is used to aid in extracting the sample of blood from the opening in the skin. The sample can be analyzed from the drops of blood that collect on the surface of the skin at the site of the opening by applying the blood directly to a glucose detector. It is preferred, however, that the sample be collected in such a manner, e.g., via a capillary tube, that it can be analyzed by conventional diagnostic devices, such as, for example, a biosensor. In another preferred embodiment, the sample can be collected in a collection zone that is integrated with a conventional diagnostic device, e.g., a biosensor.
- In an alternative of the aforementioned preferred embodiment, the availability of blood in the area of the skin from which the sample is to be extracted can be increased by means of applying thermal energy to that area of skin. The thermal energy causes the blood in that area of the skin to flow more rapidly, thereby allowing more blood to be collected per given unit of time. In this alternative embodiment, steps (a) and (b) can be carried out in the same manner as they were carried out in the aforementioned preferred embodiment.
- In another aspect of the invention, an apparatus for collecting a sample of body fluid for analysis in a diagnostic test, e.g., blood, is provided. In a preferred embodiment, the apparatus comprises:
- (a) a housing;
- (b) 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
- (c) a vacuum pump.
- It is also possible to dispense with the housing. However, the housing is preferred for the convenience of the patient and the protection of the components.
- The vacuum pump requires a source of power. If the apparatus includes a housing, the source of power can be disposed within the housing. Alternatively, the source of power can be external to the housing.
- The preferred device for forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted is a lancing assembly, which comprises a lancet for forming an opening in the skin. Alternatively, the unobstructed opening in the skin can be formed by a laser or a fluid jet.
- The vacuum pump can serve the dual purposes of (1) stretching the skin and (2) enhancing the extraction of the sample of blood from the unobstructed opening in the skin. Preferably, the vacuum pump can serve the triple purposes of (1) stretching the skin, (2) increasing the availability of blood to the area of the skin from which the sample is to be extracted, and (3) enhancing the extraction of the sample of blood from the unobstructed opening in the skin. Preferably, the housing further contains electronics having programmed instructions to switch the vacuum pump on and off to maintain the desired level of vacuum.
- The apparatus preferably contains valves, such as, for example, solenoid valves, for triggering the lancet of the lancing assembly and releasing the vacuum at the conclusion of the blood extraction procedure. The apparatus can optionally contain a heating element to increase the availability of blood to the area of the skin from which the sample is to be extracted. The apparatus can also contain a glucose detector integrated with the apparatus, e.g., a biosensor, to analyze the sample of blood collected by the apparatus.
- The method and apparatus of this invention provide several advantages over the methods and apparatus of the prior art. First, a sufficient amount of blood can be extracted from parts of the body, other than the finger, for conducting glucose monitoring tests. Second, by rendering other parts of the body suitable for extracting blood, the use of a painful finger lance can be avoided. Third, by increasing the availability of blood at the site where the blood is to be extracted, the period of time required for extracting the sample can be reduced. Because of these advantages, the diabetic patient is more likely to monitor glucose levels in the blood at the intervals prescribed by his doctor.
- FIG. 1 is a plan view of the components of a preferred embodiment of the apparatus of this invention. In this Figure, the cover of the housing is removed.
- FIG. 2 is a schematic diagram illustrating how a vacuum causes a portion of the skin to become stretched prior to the formation of an opening in the skin from which the sample of blood is extracted. FIG. 2 also illustrates the spatial relationship between the nosepiece of lancing assembly and a glucose detector, e.g., a biosensor.
- FIG. 3 is a block diagram illustrating the electronics of the preferred embodiment.
- FIG. 4 is a schematic diagram illustrating an alternative seal for the vacuum of the device of the present invention.
- The embodiments of this invention require the following steps to carry out the function of obtaining a sample of blood for carrying out a diagnostic test, e.g., glucose monitoring:
- (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.
- The step of forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted is carried out by a piercing device or some other type of device capable of forming an unobstructed opening in the skin. Piercing devices suitable for this invention include, but are not limited to, mechanical lancing assemblies. Other type of device capable of forming an unobstructed opening in the skin include, but are not limited to, lasers and fluid jets. Other types of devices capable of forming an unobstructed opening in the skin can be used, and this disclosure should not be construed so as to be limited to the devices listed. Mechanical lancing assemblies are well-known in the art. These assemblies comprise include standard steel lancets, serrated devices, and multiple tip devices. The lancets can be made from metal or plastic. Multiple tip devices provide redundancy, which can reduce the number of failures and increase the volume of blood extracted.
- Lasers suitable for forming an unobstructed opening in the skin to draw blood are also well-known in the art. See for example, U.S. Pat. Nos. 4,775,361, 5,165,418, 5,374,556, International Publication Number WO 94/09713, and Lane et al. (1984) IBM Research Report—“Ultraviolet-Laser Ablation of Skin”, all of which are incorporated herein by reference. Lasers that are suitable for forming an unobstructed opening in the skin the skin include Er:YAG, Nd:YAG, and semiconductor lasers.
- Fluid jets suitable for forming an unobstructed opening in the skin employ a high pressure jet of fluid, preferably a saline solution, to penetrate the skin.
- Regardless of what type of device is utilized to form an unobstructed opening in the skin, the opening formed by the device must be unobstructed. As used herein, the term “unobstructed” means free from clogging, hampering, blocking, or closing up by an obstacle. More specifically, the expressions “unobstructed opening in the area of the skin from which the sample is to be extracted”, “unobstructed opening in the skin”, and the like are intended to mean that the portion of the opening below the surface of the skin is free from any foreign object that would clog, hamper, block, or close up the opening, such as, for example, a needle of any type. For example, if a lancet is used to form the opening, it must be retracted from the opening prior to the commencement of the extraction of blood. Because lasers and fluid jets do not require contact with the skin to form openings in the skin, these types of devices typically provide unobstructed openings. However, these expressions are not intended to include foreign objects at the surface of the skin or above the surface of the skin, such as, for example, a glucose monitor. This feature, i.e., the unobstructed opening, can be contrasted with the opening used in the method and apparatus described in U.S. Pat. No. 5,320,607, in which the piercing and cutting means remains in the skin during the duration of the period of blood extraction. By leaving the opening unobstructed, blood can be extracted much more rapidly from the opening than it would be extracted if the piercing and cutting means were allowed to remain in the opening. In addition, the requirement of an unobstructed opening exposes the body to a foreign object either not at all or for only a very short period of time, which is welcomed by the patient.
- The step of extracting the sample of blood from the opening in the skin is carried out by a combination of extraction enhancing elements. Extraction enhancing elements suitable for use in this invention include, but are not limited to, vacuum, skin stretching elements, and heating elements. It has been discovered that when these elements are used in combination, the volume of blood extracted is greatly increased, particularly when a vacuum is applied in combination with skin stretching. In this combination, the vacuum not only causes the blood to be rapidly removed from the unobstructed opening by suction, it also causes a portion of the skin in the vicinity of the opening to be stretched. Stretching of the skin can be effected by other means, such as mechanical means or adhesives. Mechanical means include devices for pinching or pulling the skin; adhesives bring about stretching of the skin by means of pulling. It is preferred to use a vacuum to effect stretching of the skin. Like a vacuum, a heating element operates more effectively in combination with other techniques, e.g., stretching of the skin.
- In the preferred embodiment of this invention, step (a), the step of forming the unobstructed opening, is preceded by the step of increasing the availability of blood at the area of the skin from which the sample is to be extracted. The availability of blood at a given area of the skin can be increased by at least two methods. In one method, a vacuum can be used to cause blood flowing through blood vessels to pool in the area of the skin where the vacuum is applied. In another method, heat can be used to cause blood flowing through blood vessels to flow more rapidly in the area of the skin where heat is applied, thereby allowing a greater quantity of blood to be extracted from the blood extraction site per unit of time. Although the step of increasing the availability of blood in the vicinity of the blood extraction site is not required, the employment of this step can result in a greater volume of blood extracted. Elements for increasing the availability of blood at a blood extraction site that are suitable for use in this invention include, but are not limited to, vacuum, localized heating element, skin stretching element, and chemicals. As stated previously, applying a vacuum to the area of the skin from which blood is to be extracted can increase blood availability under and within the skin at the application site. The vacuum can also be used to stretch the skin upwardly into a chamber, thereby increasing pooling of blood under and within the skin. This combination of vacuum and skin stretching can be an extension of the combination used to extract blood from the opening in the skin, as previously described. It is well-known that heat can increase perfusion on the large scale of a limb or a finger. Chemical means, such as histamine, can be used to cause a physiological response to increase perfusion under and within the skin.
- In the preferred embodiments of the invention, the extracted blood is also collected. The step of collecting the sample of blood can be carried out in a variety of ways. For example, the blood can be collected in capillary tubes or absorbent paper. Alternatively, the blood can be allowed to remain in the lancet assembly, from which it can used directly in a diagnostic test. Most preferably, the sample of blood is collected on the application zone of a glucose detector, from where it can be used directly to provide an indication of the concentration of glucose in the blood. Regardless of the manner in which the blood sample is collected, the sample can be analyzed at a time later than the time of collection or at a location remote from the location of collection or both.
- A preferred embodiment of the invention will now be described in detail. Blood extraction device10 comprises a
housing 12. Disposed within thehousing 12 are avacuum pump 14, a lancingassembly 16, abattery 18, andelectronics 20. Aswitch 22 is provided to activateelectronics 20. - The
housing 12 is preferably made from a plastic material. It is preferably of sufficient size to contain all of the components that are required for forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted, extracting the sample of blood from the unobstructed opening in the skin, preferably with the aid of a vacuum and a stretching of the skin, and collecting the extracted sample in an amount sufficient to carry out a diagnostic test. Methods of preparing thehousing 12 are well-known to one of ordinary skill in the art. As stated previously, thehousing 12 is not required, but is preferred for the convenience of the patient and the protection of the components. - The
vacuum pump 14 must be capable of providing a vacuum that will provide sufficient suction to stretch the portion of the skin in the region from which the sample of blood is to be extracted. Typically, the portion of stretched skin is raised a distance of 1 to 10 mm, preferably 3 to 5 mm, from the plane of the body part of which it is a portion. As the suction provided by thevacuum pump 14 is stretching the appropriate portion of skin, the suction provided by thevacuum pump 14 also causes the stretched portion to become engorged with blood. The level of suction provided must be sufficient to cause a relatively large volume of blood to become engorged at the point that the vacuum is applied. Thevacuum pump 14 must also be capable of providing sufficient suction to extract blood from the opening in the skin at a rate sufficient to extract at least 1 μL of blood within a period of five minutes. Avacuum pump 14 that is suitable for the device of this invention can be a diaphragm pump, a piston pump, a rotary vane pump, or any other pump that will perform the required functions set forth previously. Typically, thevacuum pump 14 employs a self-contained permanent magnet DC motor. Vacuum pumps that are suitable for this invention are well-known to those of ordinary skill in the art and are commercially available. A vacuum pump suitable for use in the present invention is available from T-Squared Manufacturing Company, Nutley, N.J., and has the part number T2-03.08.004. - The
vacuum pump 14 is preferably capable of providing a pressure of down to about −14.7 psig, and is more preferably operated at from about −3.0 psig to about −10.0 psig. The area of the skin subjected to vacuum preferably ranges up to about 50 cm2, more preferably from about 0.1 to about 5.0 cm2. The period of vacuum application prior to forming the opening in the skin, i.e., for increasing the availability of blood to the application site, preferably ranges up to about 5 minutes, preferably from about 1 to about 15 seconds. The period of vacuum application subsequent to forming the opening in the skin, i.e., for aiding in the extraction of blood from the unobstructed opening, preferably ranges up to about 5 minutes, preferably from about 1 to about 60 seconds. The vacuum provided by thevacuum pump 14 can be continuous or pulsed. A continuous vacuum is preferred for the reason that it requires fewer components than does a pulsed vacuum. It is preferred that the vacuum applied not cause irreversible damage to the skin. It is preferred that the vacuum applied not produce bruises and discolorations of the skin that persist for several days. It is also preferred that the level of vacuum applied and duration of application of vacuum not be so excessive that it causes the dermis to separate from the epidermis, which results in the formation of a blister filled with fluid. - The vacuum pump feature offers significant advantages over the method and apparatus described in U.S. Pat. No. 5,320,607, in which a sealed vacuum chamber in a state of preexisting reduced pressure is used. The use of a vacuum pump provides the user with greater control of blood extraction conditions than does a sealed vacuum chamber in a state of preexisting reduced pressure. For example, if the vacuum is insufficient, energy can be provided to the vacuum pump to bring about a higher level of vacuum, thereby providing greater suction.
- The lancing
assembly 16 comprises at least one lancet. Standard lancets can be used in the lancing assembly of this invention. Narrow gauge (28 to 30 gauge) lancets are preferred. Lancets suitable for this invention can be made from metal or plastic. Lancets suitable for this invention can have single points or multiple points. The depth of penetration of the lancet preferably ranges from about 0.4 to about 2.5 mm, more preferably from about 0.4 to about 1.6 mm. The length of the lancet or lancets preferably ranges from about 1 mm to about 5 mm. The lancing assembly is preferably located so that the user can easily replace used lancets. The lancet of the lancingassembly 16 can be cocked manually or automatically, e.g., by means of a vacuum-actuated piston or diaphragm. The lancet of the lancingassembly 16 can be triggered by manually or automatically, e.g., by means of a vacuum-actuated piston or diaphragm. - Lancing assemblies are well-known in the art. Representative examples of lancing assemblies suitable for this invention are described in U.S. Pat. Nos. Re. 32,922, 4,203,446, 4,990,154, and 5,487,748, all of which are incorporated herein by reference. A particularly suitable lancing assembly for this invention is described in U.S. Pat. No. Re. 32,922. However, any lancing assembly selected should operate in conjunction with the other features of the apparatus of this invention. For example, if a vacuum is employed, the lancing assembly must be designed so that a vacuum can be formed and drawn through the assembly. The lancing assembly can be designed to allow automatic cocking and automatic triggering of the lancet.
- The
vacuum pump 14 is connected to the lancingassembly 16 by anevacuation tube 24. The air that is evacuated from the lancingassembly 16 by thevacuum pump 14 is removed via theevacuation tube 24. Theevacuation tube 24 is typically made from a polymeric material. Acheck valve 26 is placed between thevacuum pump 14 and the lancingassembly 16 at a point in theevacuation tube 24 to prevent air removed from the lancingassembly 16 by thevacuum pump 14 from flowing back to the lancingassembly 16 and adversely affecting the vacuum. - A source of power for the
vacuum pump 14 can be disposed within thehousing 12. A source of power suitable for the device of this invention is abattery 18. Alternatively, an external source of power can be used to operate thevacuum pump 14. The power source is actuated by theelectronics 20, which, in turn, is actuated by theswitch 22. - The
electronics 20 may incorporate a microprocessor or microcontroller. The function of theelectronics 20 is to switch power on and off to operate the various components in the apparatus. These components include, but are not limited to, thevacuum pump 14. Theelectronics 20 can also be use to switch power on and off to operate components in alternative embodiments, e.g., heating elements, lancets, indicating devices, and valves. Electronics suitable for this invention is the “TATTLETALE MODEL 5F” controller/data logger, commercially available from Onset Computer Corporation, 536 MacArthur Blvd. P.O. Box 3450, Pocasset, Mass. 02559-3450. Auxiliary electronic devices, such as power transistors, pressure monitors, and OP-Amps (operational amplifiers), may also be required in order to provide an interface between the controller and the operational components. All electronics required for this invention are well-known to one of ordinary skill in the art and are commercially available. Auxiliary electronic devices suitable for use in this invention include the following components:Component Source Catalog Number Mosfet Drivers International Rectifier IRLD024 El Segundo, CA Op-Amp National Semiconductor LM358 Santa Clara, CA Status LED Hewlett-Packard HLMPD150 Newark Electronics Schaumburg, IL Pressure Sensor Sensym, Inc. SDX15D4 Milpitas, CA - FIG. 3 illustrates by way of a block diagram how the foregoing electronic components can be arranged to carry out the method of the present invention.
- Operation of the blood extraction device10 will now be described. Referring now to FIGS. 1, 2 and 3, the
nosepiece 30 of the lancingassembly 16 is applied to the surface of the skin, designated herein by the letter “S”. The end of thenosepiece 30 that contacts the skin is equipped with aseal 32. The purpose of theseal 32 is to prevent air from leaking intoblood extraction chamber 34, so that thevacuum pump 14 can provide sufficient suction action for increasing the availability of blood to the area of the skin from which the sample is to be extracted, stretching the skin, and extracting the sample of blood from the unobstructed opening in the skin. Theseal 32 surrounds anopening 33 in thenosepiece 30. Theopening 33 in the nosepiece allows communication between the surface of the skin and ablood extraction chamber 34 in thenosepiece 30. Theseal 32 is preferably made of a rubber or an elastomeric material. FIG. 4 illustrates an alternative position for theseal 32. In FIG. 4, the seal is designated by thereference numeral 32′. The remaining parts of FIG. 4 are the same as those of FIG. 2, and , accordingly, retain the same reference numerals as were used in FIG. 2. - The
switch 22 is actuated, typically by being pressed, thereby activating theelectronics 20, which starts thevacuum pump 14. Thevacuum pump 14 then provides a suction action. The suction action of thevacuum pump 14 causes the skin circumscribed by theseal 32 to become engorged with blood. Engorgement of the skin with blood is accompanied by a stretching of and rising up of the skin up toopening 33. - After an appropriate period of time, which is typically pre-set by the programmer of the electronics, the lancing
assembly 16 is triggered, thereby causing thelancet 36 to penetrate the skin that has risen up to theopening 33 and that is engorged with blood. Thelancet 36 is preferably triggered automatically, by asolenoid valve 38 that causes a vacuum-actuated piston (not shown) to trigger thelancet 36. Thelancet 36 is then retracted, preferably automatically. Thereupon, the blood flows out of the unobstructed opening resulting from thelancet 36, and, aided by the vacuum generated by thevacuum pump 14, is collected. When sufficient blood has been collected or a pre-set time interval has passed, theelectronics 20 causes thevacuum pump 14 to stop. The device 10 can then be removed from the surface of the skin after another solenoid valve (not shown because it is hidden under solenoid valve 38) is opened to vent the vacuum to allow ease of removal of the device from the surface of the skin. Solenoid valves suitable for use with the apparatus described herein are commercially available from The Lee Company, Essex, Conn. and have the part number LHDA0511111H. - The blood is preferably directly collected on the application zone of a glucose detector, e.g., a reflectance strip or biosensor. The blood can then be used as the sample for a determination of glucose concentration in blood. Alternatively, the blood can be collected by other collection devices, such as, for example, a capillary tube or absorbent paper.
- The apparatus of the present invention can include a glucose detector for analyzing the blood sample extracted by the apparatus. Glucose detectors are well-known in the art. With respect to glucose monitoring, there are two major categories of glucose detectors—reflectometers and biosensors. Representative examples of reflectometers suitable for this invention are described in U.S. Pat. No. 4,627,445, incorporated herein by reference. Representative examples of biosensors suitable for this invention are described in U.S. Pat. No. 5,509,410, incorporated herein by reference.
- The glucose detector is preferably disposed in the
nosepiece 30 of the lancingassembly 16. The glucose detector must be located at a position sufficiently close to the site of blood extraction so that the quantity of extracted blood collected will be sufficient to carry out a standard glucose monitoring test. Typically, this distance will preferably be no more than 5 mm from the site of blood extraction, more preferably no more than 3 mm from the site of blood extraction, most preferably no more than 1 mm from the site of blood extraction. Care must be taken in the placement of the glucose detector so that the detector does not adversely affect the vacuum, when a vacuum is employed to aid in the extraction of blood. In addition, theglucose detector 40 should be modified, if necessary, so that the blood collected in the collection zone of the glucose detector is capable of being used to activate the glucose detector. - FIG. 2 also illustrates a manner for disposing a
glucose detector 40 in thenosepiece 30 of the lancingassembly 16. - This invention provides numerous advantages over blood extraction devices of the prior art. Among these advantages are the following:
- 1. Ability to use parts of the body, other than the finger, as a site for the extraction of blood;
- 2. Reduction of pain by eliminating the need to lance the finger;
- 3. Increase in speed of collection of blood samples by means of pre-treatment comprising a combination of stretching of the skin in conjunction with heat or vacuum or both heat and vacuum;
- 4. Incorporation of glucose detector in apparatus for extracting the blood sample.
- The following examples illustrate various features of the present invention but is not intended to in any way limit the scope of the invention as set forth in the claims. In the following examples, the term “pierce” and forms thereof and the term “puncture” and forms thereof are used interchangeably.
- This example illustrates that greater volumes of blood can be extracted and collected by applying a vacuum, pulsed or continuous, after piercing than can be extracted and collected when no vacuum is applied. No vacuum was applied prior to piercing.
- Each of four people had his forearm (dorsal forearm) punctured four times (at four different positions on the forearm) with a “BD ULTRA-FINE” lancet in a “MEDISENSE” lancet assembly (Model no. 97101) at two different levels of vacuum (−2.5 psig and −5.0 psig) and for each different vacuum pulsing frequencies (0, 0.2, 0.8, 3.2, 12.8, 25, 100 hertz). The vacuum was applied with a pipette tip having a diameter of 8 mm (“RAININ RT-200”). Four control runs without a vacuum were also carried out (one puncture per person). A total of 60 punctures per person were carried out. Accordingly, it can be seen that a total of 240 runs were carried out.
- The vacuum was applied for a duration of 30 seconds after puncturing. Blood was collected into capillary tubes. In the control runs, the samples were extracted and collected 30 seconds after puncturing. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Sensation of pain was also recorded. The following pain scores were used:
- Pain of 1=person did not feel anything or not sure if anything was felt
- Pain of 2=person felt definite prick, not as painful as piercing of finger by standard finger lancet
- Pain of 3=person felt definite pain, approximately equal to a piercing of finger by standard finger lancet
-
TABLE I Average Percent of Average Percent of volume of samples volume of samples blood sample having >1 μL blood sample having >1 μL collected at of blood collected at of blood Frequency −2.5 psig collected at −5.0 psig collected at (hertz) (μL) −2.5 psig (μL) −5.0 psig 0 1.6 69 3.1 94 (Con- tinuous) 0.2 1.1 44 3.0 94 0.8 1.1 63 75 3.2 1.5 56 3.8 75 12.8 1.8 75 3.1 100 25 2.3 75 3.2 94 100 2.4 81 2.7 88 - With no vacuum, average volume of blood collected was 0.8 μL and 31% of the samples collected contained more than 1 μL. The pain results were as follows:
pain of 1 = 81% pain of 2 = 17% pain of 3 = 2% - The control runs (no vacuum) provided much lower volumes of blood collected than did the runs where vacuum was applied. Increased vacuum resulted in higher volumes of blood extracted. The pain was minimal, with only 2% of the punctures resulting in pain comparable to that resulting from a piercing of the finger.
- This example illustrates that application of vacuum prior to piercing as well as after piercing results in a greater volume of blood extracted than does the application of vacuum only after piercing.
- Each of four people had his forearm (dorsal forearm, middle of forearm) punctured sixteen times (at sixteen different positions on the forearm) with a “BD ULTRA-FINE” lancet in a modified “MEDISENSE” lancet assembly at four different levels of vacuum. The four levels of vacuum used were −2.5, −5.0, −7.5, and −10.0 psig. The “MEDISENSE” lancet device was modified to allow vacuum to be pulled through the lancet assembly. Four punctures per person were carried out at each of the four levels of continuous vacuum. Accordingly, it can be seen that a total of 64 runs were carried out.
- Prior to puncturing, the vacuum was applied for a period of 30 seconds; subsequent to puncturing, the vacuum was applied for a period of 30 seconds. The skin was under vacuum at the time the lancet was triggered. After the lancet was triggered, the lancet assembly was removed, and the vacuum was used to apply the same level of vacuum that had been used for the vacuum prior to puncturing. The vacuum, both prior to puncturing and subsequent to puncturing, was applied with a pipette tip having a diameter of 8 mm (“RAININ RT-200”). The pipette tip of the vacuum device was held level to the plane of the skin. Blood was then collected into capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Sensation of pain was also recorded. Blood collection results are set forth in TABLE II.
TABLE II Percent of samples Average volume of blood having >1 μL of blood Vacuum level (psig) sample collected (μL) collected −2.5 4.6 94 −5.0 7.8 100 −7.5 9.2 100 −10.0 14.0 100 - The pain results were as follows:
pain of 1 = 58% pain of 2 = 31% pain of 3 = 11% - A nearly linear relationship between level of vacuum and volume of blood collected was observed. The average volume of blood collected with vacuum applied prior and after piercing was approximately twice that collected with vacuum applied only after piercing without vacuum applied prior to piercing. See the results of Example 1 for this comparison (7.8 μL vs. 3.1 μL). The volume of blood collected was always above 1 μL for all levels of vacuum, except −2.5 psig.
- This example illustrates that localized heating of the area to be pierced followed by vacuum after piercing results in a greater volume of blood being extracted than does extraction with only vacuum after piercing.
- Each of four people had his forearm (dorsal forearm, middle of forearm) punctured eight times (at eight different positions on the forearm) with a “BD ULTRA-FINE” lancet in a “MEDISENSE” lancet assembly with heat applied (45° C.) prior to piercing for two different time periods, 15 seconds and 60 seconds. A total of 32 runs were carried out, 16 runs where the pre-heating duration was 15 seconds and 16 runs where the pre-heating duration was 60 seconds.
- Heat was applied with a heating block, which was an aluminum block having a square face covered with a “KAPTON” film heater element controlled by an “OMEGA” DP41 temperature controller using a T-type thermocouple. Vacuum was applied after each puncturing for 30 seconds at −5.0 psig. Blood was collected into capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Pain was also tracked. Blood collection results are set forth in TABLE III.
TABLE III Percent of samples Pre-piercing heating Average volume of blood having >1 μL of blood duration (seconds) samples collected (μL) collected 15 6.91 94 60 11.6 100 - The pain results were as follows:
pain of 1 = 91% pain of 2 = 9% pain of 3 = 0% - The average volume of blood collected using a pre-heating duration of 15 seconds was more than twice the average volume of blood collected at a post-puncturing vacuum level of −5.0 psig., with no pre-heating. See the results of Example 1 for this comparison (6.91 μL vs. 3.1 μL). The average volume of blood collected using a pre-heating duration of 60 seconds was approximately four times the average volume of blood collected at a post-puncturing vacuum level of −5.0 psig, with no pre-heating. See the results of Example 1 for this comparison (11.6 μL vs. 3.1 μL).
- This example illustrates the effect that stretching the skin upwardly with a vacuum has on the extraction of blood.
- Each of four people had his forearm (dorsal forearm, middle of forearm) punctured eight times (at eight different positions on the forearm) with a “BD ULTRA-FINE” lancet in a “MEDISENSE” lancet assembly. Vacuum was applied for a period of 30 seconds prior to puncturing at −5.0 psig using two different vacuum fixtures. The first fixture was a 15 mm diameter vacuum fixture (i.e., a hollow cylindrical tube) used without a net strung across the opening of the tube. The second fixture was a 15 mm diameter vacuum fixture (i.e., a hollow cylindrical tube) used with a net strung across the opening of the tube. The net prevented skin from being raised up into the vacuum fixture. The same vacuum fixture used prior to puncturing was applied for a period of 30 seconds after puncturing. The fixture was held level with the plane of the skin. Four punctures were carried out per person per condition (without net, with net). Accordingly, it can be seen that a total of 32 runs were carried out. Blood was collected into capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Sensation of pain was also recorded. Blood collection results are set forth in TABLE IV.
TABLE IV Percent of samples Average volume of blood having >1 μL of blood Net across nosepiece sample collected (μL) collected No 5.2 87 Yes 0.6 19 - The pain results were as follows:
pain of 1 = 94% pain of 2 = 6% pain of 3 = 0% - The magnitude of the difference in volume of blood collected and success rates (i.e., percent of samples having >1 μL of blood collected) between the condition of stretching the skin in combination with a vacuum and the condition of not stretching the skin in combination with a vacuum was unexpected. The pain scores were low. This example demonstrates that the combination of skin stretching and applied vacuum significantly increased the volume of blood extracted.
- This example illustrates the effect the area of the extraction site has on the volume of blood collected.
- Each of four people had his forearm (dorsal forearm, middle of forearm) punctured at 32 different positions on the forearm with a “BD ULTRA-FINE” lancet in a modified “MEDISENSE” lancet assembly. The “MEDISENSE” lancet assembly had been modified with a more powerful spring and a port had been added.
- Vacuum was applied for less than five seconds prior to puncturing. The forearm was punctured under a vacuum of either −5.0 psig or −7.5 psig. The vacuum applied was maintained for 30 seconds after puncturing. The diameter of the pipette tip used to apply vacuum after puncturing was varied, with diameters of 4, 6, 8, and 10 mm being used. Four punctures per condition (diameter, vacuum level) were carried out per person. Accordingly, it can be seen that a total of 128 runs were carried out. Blood was collected into capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Sensation of pain was also recorded. Blood collection results are set forth in TABLE VA and VB.
TABLE VA vacuum level = −5.0 psig Percent of samples Vacuum diameter Average volume of blood having >1 μL of blood (mm) sample collected (μL) collected 4 0.3 0 6 1.7 69 8 3.4 94 10 4.1 100 -
TABLE VB vacuum level = −7.5 psig Percent of samples Average volume of blood having > 1 μL of Vacuum diameter (mm) sample collected (μL) blood collected 4 0.8 25 6 3.1 94 8 3.4 81 10 6.3 94 - The pain results were as follows:
pain of 1 = 89% pain of 2 = 10% pain of 3 = 1% - The volume of blood collected and success rates (i.e., percent of samples having >1 μL of blood collected) were found to vary directly with the area of skin raised up into the device by the vacuum. A much greater volume of skin was raised up into the larger diameter pipette tip than into the smaller diameter pipette tips.
- This example illustrates that a plastic multiple point lancet can be used with heat and vacuum to collect a useful amount of blood.
- Each of four people had his forearm (dorsal forearm, middle of forearm) punctured sixteen times (at sixteen different positions on the forearm) with a Greer Derma PIK® System for allergy testing (Greer Laboratories, Inc., Lenoir, N.C. 28645) modified to fit into a “MEDISENSE” lancet assembly. Pre-heating was carried out at approximately 40° C. and 45° C. for 15 and 60 seconds prior to puncturing. Four punctures were carried out per condition (temperature, time) per person. Accordingly, it can be seen that a total of 64 runs were carried out.
- Heat was applied with a heating block, which comprised an aluminum block having one face covered with a “KAPTON” film heater element controlled by an “OMEGA” DP41 temperature controller using a T-type thermocouple and the opposite face in contact with the larger base of a frustum of a cone made of copper. The larger base of the frustum had a diameter of 0.50 in. The height of the frustum was 0.50 in. The smaller base of the frustum had a diameter of 0.35 in. The smaller base had a cylindrical opening having a diameter of 0.125 in. The cylindrical opening had a common axis with the frustum. The cylindrical opening reduced the heating surface of the copper frustum. Vacuum (−5.0 psig) was applied for a period of 30 seconds after puncturing. The vacuum in contact with the skin was formed by a pipette tip having a diameter of 8 mm. The pipette tip was held level with the plane of the skin. Blood was collected into capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 μL was calculated. Sensation of pain was also recorded. Blood collection results are set forth in TABLE VI.
TABLE VI Average volume of Percent of samples Temperature (° C.)/ blood having > 1 (μL) of Time (seconds) sample collected (μL) blood collected 40/15 2.4 31 40/60 2.6 50 45/15 2.3 56 45/60 5.2 81 - The pain results were as follows:
pain of 1 = 100% pain of 2 = 0% pain of 3 = 0% - This example demonstrates that a blood extraction process employing a multi-point plastic lancet, pre-piercing heating, skin stretching, and post-piercing vacuum can extract at least 1 μL of blood at least 50% of the time.
- Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth herein.
Claims (30)
1. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:
(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;
(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin.
2. The method of , wherein said diagnostic test is a test to determine the concentration of glucose in blood.
claim 1
3. The method of , further comprising the step of increasing the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
claim 1
4. The method of , wherein a vacuum is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
claim 3
5. The method of , wherein stretching is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
claim 4
6. The method of , wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
claim 3
7. The method of , wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
claim 6
8. The method of , wherein said opening in said area of said skin from which the sample is to be extracted is formed by a lancet.
claim 1
9. The method of , wherein said lancet is cocked by means of a vacuum.
claim 8
10. The method of , wherein said lancet is triggered by means of a vacuum.
claim 8
11. The method of , wherein said extracted sample is analyzed by means of a glucose detector.
claim 1
12. The method of , wherein said glucose detector employs a reflectometer.
claim 11
13. The method of , wherein said glucose detector employs a biosensor.
claim 11
14. The method of , wherein said lancet penetrates said skin to a depth of no more than 1.6 mm.
claim 8
15. The method of , wherein said opening in said area of said skin from which the sample is to be extracted is formed by a laser.
claim 1
16. The method of , wherein said opening in said area of said skin from which the sample is to be extracted is formed by a fluid jet.
claim 1
17. The method of , wherein said blood is obtained from a forearm.
claim 1
18. The method of , wherein said blood is obtained at a pain level lower than that experienced when a finger is pierced by a standard finger lancet.
claim 1
19. An apparatus for suitable for obtaining a sample of body fluid for analysis in a diagnostic test, said apparatus comprising:
(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted; and
(b) a vacuum pump for extracting said sample from said unobstructed opening in said area of said skin.
20. The apparatus of , further including a housing.
claim 19
21. The apparatus of , wherein said device for forming said unobstructed opening comprises a lancet disposed in a lancing assembly.
claim 19
22. The apparatus of , wherein said lancing assembly comprises a nosepiece having a seal, whereby a vacuum can be formed through the lancing assembly by said vacuum pump.
claim 21
23. The apparatus of wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.
claim 19
24. The apparatus of , wherein said device for forming said unobstructed opening is a laser.
claim 19
25. The apparatus of wherein said device for forming said unobstructed opening is a fluid jet.
claim 19
26. The apparatus of , further comprising a heating element.
claim 19
27. The apparatus of , further comprising a glucose detector.
claim 19
28. The apparatus of , wherein said glucose detector is a biosensor.
claim 27
29. The apparatus of , wherein said glucose detector is a reflectometer.
claim 27
30. The apparatus of , wherein said vacuum is applied by a fixture having a major dimension ranging from about 2 mm to about 10 mm.
claim 22
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/532,729 US6283926B1 (en) | 1996-12-06 | 2000-03-22 | Method and apparatus for obtaining blood for diagnostic tests |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/759,698 US6063039A (en) | 1996-12-06 | 1996-12-06 | Method and apparatus for obtaining blood for diagnostic tests |
US09/532,729 US6283926B1 (en) | 1996-12-06 | 2000-03-22 | Method and apparatus for obtaining blood for diagnostic tests |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/759,698 Continuation US6063039A (en) | 1996-12-06 | 1996-12-06 | Method and apparatus for obtaining blood for diagnostic tests |
Publications (2)
Publication Number | Publication Date |
---|---|
US6283926B1 US6283926B1 (en) | 2001-09-04 |
US20010031931A1 true US20010031931A1 (en) | 2001-10-18 |
Family
ID=25056630
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/759,698 Expired - Lifetime US6063039A (en) | 1996-12-06 | 1996-12-06 | Method and apparatus for obtaining blood for diagnostic tests |
US09/532,729 Expired - Lifetime US6283926B1 (en) | 1996-12-06 | 2000-03-22 | Method and apparatus for obtaining blood for diagnostic tests |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/759,698 Expired - Lifetime US6063039A (en) | 1996-12-06 | 1996-12-06 | Method and apparatus for obtaining blood for diagnostic tests |
Country Status (1)
Country | Link |
---|---|
US (2) | US6063039A (en) |
Cited By (79)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20020103499A1 (en) * | 2001-01-22 | 2002-08-01 | Perez Edward P. | Lancet device having capillary action |
US20040059256A1 (en) * | 2001-09-26 | 2004-03-25 | Edward Perez | Method and apparatus for sampling bodily fluid |
US20080139903A1 (en) * | 2006-12-08 | 2008-06-12 | Isense Corporation | Method and apparatus for insertion of a sensor using an introducer |
US20080319291A1 (en) * | 2000-11-21 | 2008-12-25 | Dominique Freeman | Blood Testing Apparatus Having a Rotatable Cartridge with Multiple Lancing Elements and Testing Means |
US20090005664A1 (en) * | 2000-11-21 | 2009-01-01 | Dominique Freeman | Blood Testing Apparatus Having a Rotatable Cartridge with Multiple Lancing Elements and Testing Means |
US20090099437A1 (en) * | 2007-10-11 | 2009-04-16 | Vadim Yuzhakov | Lancing Depth Adjustment Via Moving Cap |
US20090281455A1 (en) * | 2006-01-05 | 2009-11-12 | Matsushita Electric Industrial Co., Ltd. | Blood test apparatus |
US7648468B2 (en) | 2002-04-19 | 2010-01-19 | Pelikon Technologies, Inc. | Method and apparatus for penetrating tissue |
US7666150B2 (en) | 1996-05-17 | 2010-02-23 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
US7666149B2 (en) | 1997-12-04 | 2010-02-23 | Peliken Technologies, Inc. | Cassette of lancet cartridges for sampling blood |
US20100056954A1 (en) * | 2008-09-02 | 2010-03-04 | Eli Oren | Device For Extracting Blood Samples |
US7674232B2 (en) | 2002-04-19 | 2010-03-09 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7682318B2 (en) | 2001-06-12 | 2010-03-23 | Pelikan Technologies, Inc. | Blood sampling apparatus and method |
US7699791B2 (en) | 2001-06-12 | 2010-04-20 | Pelikan Technologies, Inc. | Method and apparatus for improving success rate of blood yield from a fingerstick |
US7713214B2 (en) | 2002-04-19 | 2010-05-11 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing |
US7717863B2 (en) | 2002-04-19 | 2010-05-18 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7727168B2 (en) | 1996-05-17 | 2010-06-01 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US7731900B2 (en) | 2002-11-26 | 2010-06-08 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US7749174B2 (en) | 2001-06-12 | 2010-07-06 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge |
US7758518B2 (en) | 2001-06-08 | 2010-07-20 | Roche Diagnostics Operations, Inc. | Devices and methods for expression of bodily fluids from an incision |
US7780631B2 (en) | 1998-03-30 | 2010-08-24 | Pelikan Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US7785272B2 (en) | 2001-06-08 | 2010-08-31 | Roche Diagnostics Operations, Inc. | Test media cassette for bodily fluid testing device |
US7828749B2 (en) | 1996-05-17 | 2010-11-09 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
US7841991B2 (en) | 1996-05-17 | 2010-11-30 | Roche Diagnostics Operations, Inc. | Methods and apparatus for expressing body fluid from an incision |
US7892183B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US7901363B2 (en) | 1996-05-17 | 2011-03-08 | Roche Diagnostics Operations, Inc. | Body fluid sampling device and methods of use |
US7901362B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7901365B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7909778B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7909774B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7909777B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc | Method and apparatus for penetrating tissue |
US7914465B2 (en) | 2002-04-19 | 2011-03-29 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7976476B2 (en) | 2002-04-19 | 2011-07-12 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
US7976478B2 (en) | 2006-03-22 | 2011-07-12 | Panasonic Corporation | Blood test apparatus and method of controlling the same |
US7981056B2 (en) | 2002-04-19 | 2011-07-19 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US7981055B2 (en) | 2001-06-12 | 2011-07-19 | Pelikan Technologies, Inc. | Tissue penetration device |
US7988645B2 (en) | 2001-06-12 | 2011-08-02 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
US8007446B2 (en) | 2002-04-19 | 2011-08-30 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8021631B2 (en) | 2002-12-23 | 2011-09-20 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US8043317B2 (en) | 2000-10-31 | 2011-10-25 | Roche Diagnostics Operations, Inc. | System for withdrawing blood |
US8079960B2 (en) | 2002-04-19 | 2011-12-20 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US8197421B2 (en) | 2002-04-19 | 2012-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8221334B2 (en) | 2002-04-19 | 2012-07-17 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8251921B2 (en) | 2003-06-06 | 2012-08-28 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
US8262614B2 (en) | 2003-05-30 | 2012-09-11 | Pelikan Technologies, Inc. | Method and apparatus for fluid injection |
US8267870B2 (en) | 2002-04-19 | 2012-09-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling with hybrid actuation |
US8282576B2 (en) | 2003-09-29 | 2012-10-09 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for an improved sample capture device |
US8296918B2 (en) | 2003-12-31 | 2012-10-30 | Sanofi-Aventis Deutschland Gmbh | Method of manufacturing a fluid sampling device with improved analyte detecting member configuration |
US8333710B2 (en) | 2002-04-19 | 2012-12-18 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8372016B2 (en) | 2002-04-19 | 2013-02-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
US8414504B2 (en) | 2006-03-22 | 2013-04-09 | Panasonic Corporation | Blood test device |
US8435190B2 (en) | 2002-04-19 | 2013-05-07 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8523784B2 (en) | 2001-08-29 | 2013-09-03 | Roche Diagnostics Operations, Inc. | Analytical device with lancet and test element |
US8556829B2 (en) | 2002-04-19 | 2013-10-15 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8574895B2 (en) | 2002-12-30 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
US8652831B2 (en) | 2004-12-30 | 2014-02-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte measurement test time |
US8668656B2 (en) | 2003-12-31 | 2014-03-11 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for improving fluidic flow and sample capture |
US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
US8721671B2 (en) | 2001-06-12 | 2014-05-13 | Sanofi-Aventis Deutschland Gmbh | Electric lancet actuator |
US8784335B2 (en) | 2002-04-19 | 2014-07-22 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling device with a capacitive sensor |
US8828203B2 (en) | 2004-05-20 | 2014-09-09 | Sanofi-Aventis Deutschland Gmbh | Printable hydrogels for biosensors |
US8876755B2 (en) | 2008-07-14 | 2014-11-04 | Abbott Diabetes Care Inc. | Closed loop control system interface and methods |
US8880138B2 (en) * | 2005-09-30 | 2014-11-04 | Abbott Diabetes Care Inc. | Device for channeling fluid and methods of use |
US8965476B2 (en) | 2010-04-16 | 2015-02-24 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9031630B2 (en) | 2006-02-28 | 2015-05-12 | Abbott Diabetes Care Inc. | Analyte sensors and methods of use |
US9144401B2 (en) | 2003-06-11 | 2015-09-29 | Sanofi-Aventis Deutschland Gmbh | Low pain penetrating member |
US9226699B2 (en) | 2002-04-19 | 2016-01-05 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling module with a continuous compression tissue interface surface |
US9248267B2 (en) | 2002-04-19 | 2016-02-02 | Sanofi-Aventis Deustchland Gmbh | Tissue penetration device |
US9314194B2 (en) | 2002-04-19 | 2016-04-19 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9351680B2 (en) | 2003-10-14 | 2016-05-31 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a variable user interface |
US9375169B2 (en) | 2009-01-30 | 2016-06-28 | Sanofi-Aventis Deutschland Gmbh | Cam drive for managing disposable penetrating member actions with a single motor and motor and control system |
US9386944B2 (en) | 2008-04-11 | 2016-07-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte detecting device |
US9427532B2 (en) | 2001-06-12 | 2016-08-30 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9775553B2 (en) | 2004-06-03 | 2017-10-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
US9795747B2 (en) | 2010-06-02 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US9795326B2 (en) | 2009-07-23 | 2017-10-24 | Abbott Diabetes Care Inc. | Continuous analyte measurement systems and systems and methods for implanting them |
US9820684B2 (en) | 2004-06-03 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
US9901296B2 (en) | 2000-03-04 | 2018-02-27 | Roche Diabetes Care, Inc. | Blood lancet with hygienic tip protection |
Families Citing this family (89)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998035225A1 (en) * | 1997-02-06 | 1998-08-13 | E. Heller & Company | Small volume in vitro analyte sensor |
US6592552B1 (en) * | 1997-09-19 | 2003-07-15 | Cecil C. Schmidt | Direct pericardial access device and method |
US6706000B2 (en) * | 1997-11-21 | 2004-03-16 | Amira Medical | Methods and apparatus for expressing body fluid from an incision |
US7066884B2 (en) * | 1998-01-08 | 2006-06-27 | Sontra Medical, Inc. | System, method, and device for non-invasive body fluid sampling and analysis |
US8287483B2 (en) | 1998-01-08 | 2012-10-16 | Echo Therapeutics, Inc. | Method and apparatus for enhancement of transdermal transport |
US6103033A (en) | 1998-03-04 | 2000-08-15 | Therasense, Inc. | Process for producing an electrochemical biosensor |
US6591125B1 (en) | 2000-06-27 | 2003-07-08 | Therasense, Inc. | Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator |
US6338790B1 (en) * | 1998-10-08 | 2002-01-15 | Therasense, Inc. | Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator |
US20040171980A1 (en) | 1998-12-18 | 2004-09-02 | Sontra Medical, Inc. | Method and apparatus for enhancement of transdermal transport |
US6654625B1 (en) | 1999-06-18 | 2003-11-25 | Therasense, Inc. | Mass transport limited in vivo analyte sensor |
US6283982B1 (en) * | 1999-10-19 | 2001-09-04 | Facet Technologies, Inc. | Lancing device and method of sample collection |
US6706159B2 (en) | 2000-03-02 | 2004-03-16 | Diabetes Diagnostics | Combined lancet and electrochemical analyte-testing apparatus |
AU2001270299A1 (en) * | 2000-07-03 | 2002-01-14 | Kodiak Technologies, Inc. | Thermal container with data monitoring system |
US7310543B2 (en) | 2001-03-26 | 2007-12-18 | Kumetrix, Inc. | Silicon microprobe with integrated biosensor |
AU2002315179A1 (en) * | 2001-06-12 | 2002-12-23 | Pelikan Technologies, Inc. | Blood sampling device with diaphragm actuated lancet |
US6678542B2 (en) * | 2001-08-16 | 2004-01-13 | Optiscan Biomedical Corp. | Calibrator configured for use with noninvasive analyte-concentration monitor and employing traditional measurements |
US7004928B2 (en) | 2002-02-08 | 2006-02-28 | Rosedale Medical, Inc. | Autonomous, ambulatory analyte monitor or drug delivery device |
US7027848B2 (en) * | 2002-04-04 | 2006-04-11 | Inlight Solutions, Inc. | Apparatus and method for non-invasive spectroscopic measurement of analytes in tissue using a matched reference analyte |
WO2003088824A2 (en) * | 2002-04-19 | 2003-10-30 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
US7291117B2 (en) | 2002-04-19 | 2007-11-06 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7371247B2 (en) * | 2002-04-19 | 2008-05-13 | Pelikan Technologies, Inc | Method and apparatus for penetrating tissue |
US7303726B2 (en) | 2002-05-09 | 2007-12-04 | Lifescan, Inc. | Minimal procedure analyte test system |
IES20020794A2 (en) * | 2002-10-04 | 2003-02-19 | Minroc Techn Promotions Ltd | A down-the-hole hammer |
DE60336834D1 (en) | 2002-10-09 | 2011-06-01 | Abbott Diabetes Care Inc | FUEL FEEDING DEVICE, SYSTEM AND METHOD |
US7993108B2 (en) | 2002-10-09 | 2011-08-09 | Abbott Diabetes Care Inc. | Variable volume, shape memory actuated insulin dispensing pump |
US7727181B2 (en) * | 2002-10-09 | 2010-06-01 | Abbott Diabetes Care Inc. | Fluid delivery device with autocalibration |
US7572237B2 (en) | 2002-11-06 | 2009-08-11 | Abbott Diabetes Care Inc. | Automatic biological analyte testing meter with integrated lancing device and methods of use |
US20060184189A1 (en) * | 2002-11-15 | 2006-08-17 | Lorin Olson | Cap for a dermal tissue lancing device |
JP4359675B2 (en) * | 2002-12-13 | 2009-11-04 | アークレイ株式会社 | Puncture device |
US20040120848A1 (en) * | 2002-12-20 | 2004-06-24 | Maria Teodorczyk | Method for manufacturing a sterilized and calibrated biosensor-based medical device |
US7052652B2 (en) | 2003-03-24 | 2006-05-30 | Rosedale Medical, Inc. | Analyte concentration detection devices and methods |
US7679407B2 (en) | 2003-04-28 | 2010-03-16 | Abbott Diabetes Care Inc. | Method and apparatus for providing peak detection circuitry for data communication systems |
US8071028B2 (en) | 2003-06-12 | 2011-12-06 | Abbott Diabetes Care Inc. | Method and apparatus for providing power management in data communication systems |
US9101302B2 (en) * | 2004-05-03 | 2015-08-11 | Abbott Diabetes Care Inc. | Analyte test device |
US7384402B2 (en) * | 2004-06-10 | 2008-06-10 | Roche Diagnostics Operations, Inc. | Expression pad |
US7582262B2 (en) * | 2004-06-18 | 2009-09-01 | Roche Diagnostics Operations, Inc. | Dispenser for flattened articles |
US7512432B2 (en) * | 2004-07-27 | 2009-03-31 | Abbott Laboratories | Sensor array |
US8211038B2 (en) | 2004-09-17 | 2012-07-03 | Abbott Diabetes Care Inc. | Multiple-biosensor article |
US8224414B2 (en) | 2004-10-28 | 2012-07-17 | Echo Therapeutics, Inc. | System and method for analyte sampling and analysis with hydrogel |
CN101180093B (en) | 2005-03-21 | 2012-07-18 | 雅培糖尿病护理公司 | Method and system for providing integrated medication infusion and analyte monitoring system |
US7768408B2 (en) | 2005-05-17 | 2010-08-03 | Abbott Diabetes Care Inc. | Method and system for providing data management in data monitoring system |
US7620437B2 (en) | 2005-06-03 | 2009-11-17 | Abbott Diabetes Care Inc. | Method and apparatus for providing rechargeable power in data monitoring and management systems |
US20060281187A1 (en) | 2005-06-13 | 2006-12-14 | Rosedale Medical, Inc. | Analyte detection devices and methods with hematocrit/volume correction and feedback control |
WO2007041244A2 (en) | 2005-09-30 | 2007-04-12 | Intuity Medical, Inc. | Multi-site body fluid sampling and analysis cartridge |
US8801631B2 (en) | 2005-09-30 | 2014-08-12 | Intuity Medical, Inc. | Devices and methods for facilitating fluid transport |
US7756561B2 (en) | 2005-09-30 | 2010-07-13 | Abbott Diabetes Care Inc. | Method and apparatus for providing rechargeable power in data monitoring and management systems |
US7583190B2 (en) | 2005-10-31 | 2009-09-01 | Abbott Diabetes Care Inc. | Method and apparatus for providing data communication in data monitoring and management systems |
US8344966B2 (en) | 2006-01-31 | 2013-01-01 | Abbott Diabetes Care Inc. | Method and system for providing a fault tolerant display unit in an electronic device |
US7885698B2 (en) | 2006-02-28 | 2011-02-08 | Abbott Diabetes Care Inc. | Method and system for providing continuous calibration of implantable analyte sensors |
EP2010276B1 (en) * | 2006-04-26 | 2014-01-22 | Covidien LP | Multi-stage microporation device |
US8372015B2 (en) * | 2006-08-28 | 2013-02-12 | Intuity Medical, Inc. | Body fluid sampling device with pivotable catalyst member |
DE602007010480D1 (en) * | 2006-09-19 | 2010-12-23 | Panasonic Corp | BLOOD SENSOR AND THESE INCLUDING BLOOD TESTING INSTRUMENT |
US8579853B2 (en) | 2006-10-31 | 2013-11-12 | Abbott Diabetes Care Inc. | Infusion devices and methods |
CA2680213C (en) | 2007-03-07 | 2014-10-14 | Echo Therapeutics, Inc. | Transdermal analyte monitoring systems and methods for analyte detection |
WO2008134545A1 (en) | 2007-04-27 | 2008-11-06 | Echo Therapeutics, Inc. | Skin permeation device for analyte sensing or transdermal drug delivery |
JP5816080B2 (en) | 2008-05-30 | 2015-11-17 | インテュイティ メディカル インコーポレイテッド | Body fluid collection device and collection site interface |
WO2009149308A2 (en) * | 2008-06-04 | 2009-12-10 | Seventh Sense Biosystems, Inc. | Compositions and methods for rapid one-step diagnosis |
JP2011522594A (en) | 2008-06-06 | 2011-08-04 | インテュイティ メディカル インコーポレイテッド | Medical diagnostic apparatus and method |
CA2726067C (en) | 2008-06-06 | 2020-10-20 | Intuity Medical, Inc. | Detection meter and mode of operation |
US8560082B2 (en) | 2009-01-30 | 2013-10-15 | Abbott Diabetes Care Inc. | Computerized determination of insulin pump therapy parameters using real time and retrospective data processing |
US20100213057A1 (en) | 2009-02-26 | 2010-08-26 | Benjamin Feldman | Self-Powered Analyte Sensor |
US9033898B2 (en) | 2010-06-23 | 2015-05-19 | Seventh Sense Biosystems, Inc. | Sampling devices and methods involving relatively little pain |
CN102405018B (en) | 2009-03-02 | 2014-11-19 | 第七感生物系统有限公司 | Techniques and devices associated with blood sampling |
US8467972B2 (en) | 2009-04-28 | 2013-06-18 | Abbott Diabetes Care Inc. | Closed loop blood glucose control algorithm analysis |
DK3173014T3 (en) | 2009-07-23 | 2021-09-13 | Abbott Diabetes Care Inc | Real-time control of data on physiological control of glucose levels |
US9770560B2 (en) | 2009-11-12 | 2017-09-26 | Pourang Bral | Means and method to administer injections with little or no pain |
US10226586B2 (en) | 2011-05-26 | 2019-03-12 | Pourang Bral | Means and method to painlessly puncture skin |
US10973994B2 (en) | 2013-09-16 | 2021-04-13 | Pourang Bral | Means and method to invade skin, mucosa, and underlying tissues with little or no pain |
US8919605B2 (en) | 2009-11-30 | 2014-12-30 | Intuity Medical, Inc. | Calibration material delivery devices and methods |
US8657763B2 (en) | 2010-01-19 | 2014-02-25 | Christopher A. Jacobs | Vacuum assisted lancing system with elective vacuum release and method for blood extraction with minimal pain |
US8460210B2 (en) * | 2010-01-19 | 2013-06-11 | Christopher A. Jacobs | Vacuum assisted lancing system with controlled rate and method for blood extraction with minimal pain |
WO2011094573A1 (en) | 2010-01-28 | 2011-08-04 | Seventh Sense Biosystems, Inc. | Monitoring or feedback systems and methods |
EP2584964B1 (en) | 2010-06-25 | 2021-08-04 | Intuity Medical, Inc. | Analyte monitoring devices |
EP2593014B1 (en) | 2010-07-16 | 2015-11-04 | Seventh Sense Biosystems, Inc. | Low-pressure environment for fluid transfer devices |
US20130158482A1 (en) | 2010-07-26 | 2013-06-20 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or receiving of fluids |
US20120039809A1 (en) | 2010-08-13 | 2012-02-16 | Seventh Sense Biosystems, Inc. | Systems and techniques for monitoring subjects |
CN103370007B (en) | 2010-11-09 | 2018-12-18 | 第七感生物系统有限公司 | System and interface for blood sampling |
US20130158468A1 (en) | 2011-12-19 | 2013-06-20 | Seventh Sense Biosystems, Inc. | Delivering and/or receiving material with respect to a subject surface |
EP3235429B1 (en) | 2011-04-29 | 2023-06-07 | YourBio Health, Inc. | Devices and methods for collection of blood from a subject |
EP2701598A1 (en) | 2011-04-29 | 2014-03-05 | Seventh Sense Biosystems, Inc. | Systems and methods for collecting fluid from a subject |
BR112013027351B1 (en) | 2011-04-29 | 2022-03-03 | Seventh Sense Biosystems, Inc | Device for receiving fluid from an individual |
WO2013020103A1 (en) | 2011-08-03 | 2013-02-07 | Intuity Medical, Inc. | Devices and methods for body fluid sampling and analysis |
BR112015026222B1 (en) | 2013-04-15 | 2022-05-17 | Becton, Dickinson And Company | Biological fluid sample collection device and biological fluid examination system |
CA2912283A1 (en) | 2013-06-21 | 2014-12-21 | Intuity Medical, Inc. | Analyte monitoring system with audible feedback |
WO2017044887A1 (en) | 2015-09-09 | 2017-03-16 | Drawbridge Health, Inc. | Systems, methods, and devices for sample collection, stabilization and preservation |
US11166658B2 (en) * | 2016-07-28 | 2021-11-09 | Invitae Corporation | Blood sampling system and method |
AU2018207302B2 (en) | 2017-01-10 | 2023-07-13 | Drawbridge Health, Inc. | Devices, systems, and methods for sample collection |
JP7438137B2 (en) | 2018-05-14 | 2024-02-26 | ループ メディカル エスアー | Sample collection devices, systems, and methods for extracting and collecting samples of user fluids |
ES2940212T3 (en) | 2019-11-13 | 2023-05-04 | Loop Medical Sa | Sample collection device for extracting and collecting a sample of a fluid from a user |
Family Cites Families (47)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US32922A (en) * | 1861-07-30 | Samuel nowlan | ||
DE596981C (en) * | 1931-10-30 | 1934-05-12 | Mario Demarchi Dr | Injection syringe |
US3815579A (en) * | 1972-06-05 | 1974-06-11 | S Rose | Blood withdrawing means |
US3815529A (en) | 1973-04-04 | 1974-06-11 | Singer Co | Manual needle elevating device |
DE2642896C3 (en) * | 1976-09-24 | 1980-08-21 | 7800 Freiburg | Precision snapper for setting standard stab wounds in the skin for diagnostic purposes |
US4273639A (en) | 1979-06-20 | 1981-06-16 | Eastman Kodak Company | Capillary bridge in apparatus for determining ionic activity |
US4360016A (en) * | 1980-07-01 | 1982-11-23 | Transidyne General Corp. | Blood collecting device |
USRE32922E (en) | 1983-01-13 | 1989-05-16 | Paul D. Levin | Blood sampling instrument |
US5509410A (en) * | 1983-06-06 | 1996-04-23 | Medisense, Inc. | Strip electrode including screen printing of a single layer |
DK492083D0 (en) * | 1983-10-26 | 1983-10-26 | Medical Press Service | APPLICATION FOR EXTINGUISHING POISON FROM BUTTONS OR BIT OF INSECTS AND OTHER ANIMALS |
FR2574299B1 (en) * | 1984-12-10 | 1987-09-11 | Thiriet Lucien | RESETABLE VACUUM CARTRIDGE AND MEANS FOR CONTAINING AND USING THE VACUUM |
FR2577808A1 (en) * | 1985-02-22 | 1986-08-29 | Alain Dubos | SUCTION DEVICE, IN PARTICULAR FOR A VENOM SUCTION SUCTION CUP, COMPRISING A VACUUM PUMP CONNECTABLE TO AN EXTERNAL CHAMBER |
US4627445A (en) * | 1985-04-08 | 1986-12-09 | Garid, Inc. | Glucose medical monitoring system |
US5279294A (en) | 1985-04-08 | 1994-01-18 | Cascade Medical, Inc. | Medical diagnostic system |
WO1986007632A1 (en) | 1985-06-21 | 1986-12-31 | Matsushita Electric Industrial Co., Ltd. | Biosensor and method of manufacturing same |
WO1987000413A1 (en) * | 1985-07-26 | 1987-01-29 | Microtech Medical Company, Inc. | Non-invasive collection means and method |
US4653513A (en) | 1985-08-09 | 1987-03-31 | Dombrowski Mitchell P | Blood sampler |
DD242962B1 (en) * | 1985-11-25 | 1989-11-15 | Bezirkskrankenhaus Karl Marx S | DEVICE FOR CAPILLARY BLOOD COLLECTION |
DE3708031A1 (en) * | 1986-03-20 | 1987-11-12 | Wolfgang Dr Med Wagner | Measurement device or induction device with measurement device, or device for material recovery for a measurement device for metabolic states in the blood by puncturing under reduced pressure in a suction cup with displacement of the measurement zone outside the tip region of the puncturing device |
US4775361A (en) * | 1986-04-10 | 1988-10-04 | The General Hospital Corporation | Controlled removal of human stratum corneum by pulsed laser to enhance percutaneous transport |
EP0254203A3 (en) | 1986-07-22 | 1988-10-05 | Personal Diagnostics, Inc. | Optical analyzer |
DE3806574A1 (en) * | 1987-03-10 | 1989-09-07 | Wolfgang Dr Med Wagner | Device for metabolic control |
GB2222251A (en) * | 1987-09-08 | 1990-02-28 | Wolfgang Wagner | Device for metabolism control |
US5362307A (en) * | 1989-01-24 | 1994-11-08 | The Regents Of The University Of California | Method for the iontophoretic non-invasive-determination of the in vivo concentration level of an inorganic or organic substance |
DE58906306D1 (en) * | 1988-10-31 | 1994-01-13 | Avl Medical Instr Ag | Device for determining the concentration of at least one substance present in organic tissue. |
EP0371503B1 (en) | 1988-11-30 | 1995-03-08 | Kyoto Daiichi Kagaku Co., Ltd. | Device for assay of liquid sample |
US5054499A (en) * | 1989-03-27 | 1991-10-08 | Swierczek Remi D | Disposable skin perforator and blood testing device |
US4990154A (en) * | 1989-06-19 | 1991-02-05 | Miles Inc. | Lancet assembly |
US5037431A (en) | 1989-11-03 | 1991-08-06 | The Curators Of The University Of Missouri | Surgical liquid lance apparatus |
KR0171222B1 (en) | 1989-12-15 | 1999-02-18 | 스티브 올드함 | Redox mediator reagent and biosensor |
US5161532A (en) * | 1990-04-19 | 1992-11-10 | Teknekron Sensor Development Corporation | Integral interstitial fluid sensor |
EP0573572B1 (en) | 1991-02-27 | 1998-01-21 | Boehringer Mannheim Corporation | Improved test strip |
CA2069060C (en) | 1991-06-26 | 2003-07-29 | Daniel Shichman | Powered trocar |
WO1993003673A1 (en) | 1991-08-22 | 1993-03-04 | Cascade Medical, Inc. | Disposable reagent unit with blood or fluid guard |
JP2572823Y2 (en) * | 1992-02-13 | 1998-05-25 | 株式会社アドバンス | Simple blood sampler |
US5165418B1 (en) * | 1992-03-02 | 1999-12-14 | Nikola I Tankovich | Blood sampling device and method using a laser |
GB9207120D0 (en) * | 1992-04-01 | 1992-05-13 | Owen Mumford Ltd | Improvements relating to blood sampling devices |
JPH0617706U (en) | 1992-06-26 | 1994-03-08 | 吉彦 鈴木 | Blood pump |
US5374556A (en) * | 1992-07-23 | 1994-12-20 | Cell Robotics, Inc. | Flexure structure for stage positioning |
JPH0824680B2 (en) * | 1992-10-26 | 1996-03-13 | 日本電気株式会社 | Suction leachate sampling device |
US5643252A (en) * | 1992-10-28 | 1997-07-01 | Venisect, Inc. | Laser perforator |
JP2630197B2 (en) * | 1993-04-28 | 1997-07-16 | 株式会社ニッショー | Blood suction device |
JP3494183B2 (en) | 1993-08-10 | 2004-02-03 | 株式会社アドバンス | Simple blood collection device |
US5554153A (en) * | 1994-08-29 | 1996-09-10 | Cell Robotics, Inc. | Laser skin perforator |
JPH08317918A (en) * | 1995-05-25 | 1996-12-03 | Advance Co Ltd | Blood drawing device |
US5569223A (en) * | 1995-06-06 | 1996-10-29 | Home Access Health Corporation | Apparatus and method for enhancing blood flow to obtain a blood sample |
US5662127A (en) * | 1996-01-17 | 1997-09-02 | Bio-Plas, Inc. | Self-contained blood withdrawal apparatus and method |
-
1996
- 1996-12-06 US US08/759,698 patent/US6063039A/en not_active Expired - Lifetime
-
2000
- 2000-03-22 US US09/532,729 patent/US6283926B1/en not_active Expired - Lifetime
Cited By (174)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8696596B2 (en) | 1996-05-17 | 2014-04-15 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
US7901363B2 (en) | 1996-05-17 | 2011-03-08 | Roche Diagnostics Operations, Inc. | Body fluid sampling device and methods of use |
US8231549B2 (en) | 1996-05-17 | 2012-07-31 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US7841991B2 (en) | 1996-05-17 | 2010-11-30 | Roche Diagnostics Operations, Inc. | Methods and apparatus for expressing body fluid from an incision |
US7828749B2 (en) | 1996-05-17 | 2010-11-09 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
US7727168B2 (en) | 1996-05-17 | 2010-06-01 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US8740813B2 (en) | 1996-05-17 | 2014-06-03 | Roche Diagnostics Operations, Inc. | Methods and apparatus for expressing body fluid from an incision |
US7666150B2 (en) | 1996-05-17 | 2010-02-23 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
US7731668B2 (en) | 1996-05-17 | 2010-06-08 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US8690798B2 (en) | 1996-05-17 | 2014-04-08 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US8123701B2 (en) | 1996-05-17 | 2012-02-28 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US7666149B2 (en) | 1997-12-04 | 2010-02-23 | Peliken Technologies, Inc. | Cassette of lancet cartridges for sampling blood |
US8439872B2 (en) | 1998-03-30 | 2013-05-14 | Sanofi-Aventis Deutschland Gmbh | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US7780631B2 (en) | 1998-03-30 | 2010-08-24 | Pelikan Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US9901296B2 (en) | 2000-03-04 | 2018-02-27 | Roche Diabetes Care, Inc. | Blood lancet with hygienic tip protection |
US9839387B2 (en) | 2000-10-31 | 2017-12-12 | Roche Diabetes Care, Inc. | System for withdrawing blood |
US8043317B2 (en) | 2000-10-31 | 2011-10-25 | Roche Diagnostics Operations, Inc. | System for withdrawing blood |
US10617340B2 (en) | 2000-10-31 | 2020-04-14 | Roche Diabetes Care, Inc. | System for withdrawing blood |
US8636758B2 (en) | 2000-10-31 | 2014-01-28 | Roche Diagnostics Operations, Inc. | System for withdrawing blood |
US20080319291A1 (en) * | 2000-11-21 | 2008-12-25 | Dominique Freeman | Blood Testing Apparatus Having a Rotatable Cartridge with Multiple Lancing Elements and Testing Means |
US20090005664A1 (en) * | 2000-11-21 | 2009-01-01 | Dominique Freeman | Blood Testing Apparatus Having a Rotatable Cartridge with Multiple Lancing Elements and Testing Means |
US8641644B2 (en) * | 2000-11-21 | 2014-02-04 | Sanofi-Aventis Deutschland Gmbh | Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means |
US8257276B2 (en) | 2001-01-22 | 2012-09-04 | Roche Diagnostics Operations, Inc. | Lancet device having capillary action |
US20020103499A1 (en) * | 2001-01-22 | 2002-08-01 | Perez Edward P. | Lancet device having capillary action |
US7803123B2 (en) | 2001-01-22 | 2010-09-28 | Roche Diagnostics Operations, Inc. | Lancet device having capillary action |
US6866675B2 (en) | 2001-01-22 | 2005-03-15 | Roche Diagnostics Operations, Inc. | Lancet device having capillary action |
US8257277B2 (en) | 2001-06-08 | 2012-09-04 | Roche Diagnostics Operations, Inc. | Test media cassette for bodily fluid testing device |
US7758518B2 (en) | 2001-06-08 | 2010-07-20 | Roche Diagnostics Operations, Inc. | Devices and methods for expression of bodily fluids from an incision |
US7785272B2 (en) | 2001-06-08 | 2010-08-31 | Roche Diagnostics Operations, Inc. | Test media cassette for bodily fluid testing device |
US9538941B2 (en) | 2001-06-08 | 2017-01-10 | Roche Diabetes Care, Inc. | Devices and methods for expression of bodily fluids from an incision |
US8986223B2 (en) | 2001-06-08 | 2015-03-24 | Roche Diagnostics Operations, Inc. | Test media cassette for bodily fluid testing device |
US8192372B2 (en) | 2001-06-08 | 2012-06-05 | Roche Diagnostics Operations, Inc. | Test media cassette for bodily fluid testing device |
US7682318B2 (en) | 2001-06-12 | 2010-03-23 | Pelikan Technologies, Inc. | Blood sampling apparatus and method |
US8206317B2 (en) | 2001-06-12 | 2012-06-26 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8721671B2 (en) | 2001-06-12 | 2014-05-13 | Sanofi-Aventis Deutschland Gmbh | Electric lancet actuator |
US8206319B2 (en) | 2001-06-12 | 2012-06-26 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7749174B2 (en) | 2001-06-12 | 2010-07-06 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge |
US8679033B2 (en) | 2001-06-12 | 2014-03-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7909775B2 (en) | 2001-06-12 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge |
US8211037B2 (en) | 2001-06-12 | 2012-07-03 | Pelikan Technologies, Inc. | Tissue penetration device |
US8641643B2 (en) | 2001-06-12 | 2014-02-04 | Sanofi-Aventis Deutschland Gmbh | Sampling module device and method |
US9427532B2 (en) | 2001-06-12 | 2016-08-30 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8622930B2 (en) | 2001-06-12 | 2014-01-07 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8216154B2 (en) | 2001-06-12 | 2012-07-10 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7699791B2 (en) | 2001-06-12 | 2010-04-20 | Pelikan Technologies, Inc. | Method and apparatus for improving success rate of blood yield from a fingerstick |
US8382683B2 (en) | 2001-06-12 | 2013-02-26 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8360991B2 (en) | 2001-06-12 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7981055B2 (en) | 2001-06-12 | 2011-07-19 | Pelikan Technologies, Inc. | Tissue penetration device |
US7988645B2 (en) | 2001-06-12 | 2011-08-02 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
US8845550B2 (en) | 2001-06-12 | 2014-09-30 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8343075B2 (en) | 2001-06-12 | 2013-01-01 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8016774B2 (en) | 2001-06-12 | 2011-09-13 | Pelikan Technologies, Inc. | Tissue penetration device |
US8337421B2 (en) | 2001-06-12 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8282577B2 (en) | 2001-06-12 | 2012-10-09 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge |
US8162853B2 (en) | 2001-06-12 | 2012-04-24 | Pelikan Technologies, Inc. | Tissue penetration device |
US9694144B2 (en) | 2001-06-12 | 2017-07-04 | Sanofi-Aventis Deutschland Gmbh | Sampling module device and method |
US9802007B2 (en) | 2001-06-12 | 2017-10-31 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US8123700B2 (en) | 2001-06-12 | 2012-02-28 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge |
US9937298B2 (en) | 2001-06-12 | 2018-04-10 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8523784B2 (en) | 2001-08-29 | 2013-09-03 | Roche Diagnostics Operations, Inc. | Analytical device with lancet and test element |
US9215993B2 (en) | 2001-08-29 | 2015-12-22 | Roche Diagnostics Operations, Inc. | Analytical device with lancet and test element |
US20040267160A9 (en) * | 2001-09-26 | 2004-12-30 | Edward Perez | Method and apparatus for sampling bodily fluid |
US20040059256A1 (en) * | 2001-09-26 | 2004-03-25 | Edward Perez | Method and apparatus for sampling bodily fluid |
US7758516B2 (en) | 2001-09-26 | 2010-07-20 | Roche Diagnostics Operations, Inc. | Method and apparatus for sampling bodily fluid |
US9560993B2 (en) | 2001-11-21 | 2017-02-07 | Sanofi-Aventis Deutschland Gmbh | Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means |
US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7901365B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8197423B2 (en) | 2002-04-19 | 2012-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8197421B2 (en) | 2002-04-19 | 2012-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8221334B2 (en) | 2002-04-19 | 2012-07-17 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8157748B2 (en) | 2002-04-19 | 2012-04-17 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US8235915B2 (en) | 2002-04-19 | 2012-08-07 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US9907502B2 (en) | 2002-04-19 | 2018-03-06 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8079960B2 (en) | 2002-04-19 | 2011-12-20 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US8062231B2 (en) | 2002-04-19 | 2011-11-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US9839386B2 (en) | 2002-04-19 | 2017-12-12 | Sanofi-Aventis Deustschland Gmbh | Body fluid sampling device with capacitive sensor |
US8267870B2 (en) | 2002-04-19 | 2012-09-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling with hybrid actuation |
US7648468B2 (en) | 2002-04-19 | 2010-01-19 | Pelikon Technologies, Inc. | Method and apparatus for penetrating tissue |
US9795334B2 (en) | 2002-04-19 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US9724021B2 (en) | 2002-04-19 | 2017-08-08 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8333710B2 (en) | 2002-04-19 | 2012-12-18 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8337420B2 (en) | 2002-04-19 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8337419B2 (en) | 2002-04-19 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7674232B2 (en) | 2002-04-19 | 2010-03-09 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8007446B2 (en) | 2002-04-19 | 2011-08-30 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7988644B2 (en) | 2002-04-19 | 2011-08-02 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with sterility barrier release |
US7981056B2 (en) | 2002-04-19 | 2011-07-19 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US8366637B2 (en) | 2002-04-19 | 2013-02-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8372016B2 (en) | 2002-04-19 | 2013-02-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
US7713214B2 (en) | 2002-04-19 | 2010-05-11 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing |
US8382682B2 (en) | 2002-04-19 | 2013-02-26 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US9498160B2 (en) | 2002-04-19 | 2016-11-22 | Sanofi-Aventis Deutschland Gmbh | Method for penetrating tissue |
US8388551B2 (en) | 2002-04-19 | 2013-03-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for multi-use body fluid sampling device with sterility barrier release |
US8403864B2 (en) | 2002-04-19 | 2013-03-26 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7717863B2 (en) | 2002-04-19 | 2010-05-18 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8414503B2 (en) | 2002-04-19 | 2013-04-09 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US8430828B2 (en) | 2002-04-19 | 2013-04-30 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a multi-use body fluid sampling device with sterility barrier release |
US8435190B2 (en) | 2002-04-19 | 2013-05-07 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7976476B2 (en) | 2002-04-19 | 2011-07-12 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
US8491500B2 (en) | 2002-04-19 | 2013-07-23 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US8496601B2 (en) | 2002-04-19 | 2013-07-30 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US9339612B2 (en) | 2002-04-19 | 2016-05-17 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9314194B2 (en) | 2002-04-19 | 2016-04-19 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8556829B2 (en) | 2002-04-19 | 2013-10-15 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8562545B2 (en) | 2002-04-19 | 2013-10-22 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8574168B2 (en) | 2002-04-19 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a multi-use body fluid sampling device with analyte sensing |
US9248267B2 (en) | 2002-04-19 | 2016-02-02 | Sanofi-Aventis Deustchland Gmbh | Tissue penetration device |
US9226699B2 (en) | 2002-04-19 | 2016-01-05 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling module with a continuous compression tissue interface surface |
US8579831B2 (en) | 2002-04-19 | 2013-11-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7959582B2 (en) | 2002-04-19 | 2011-06-14 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7938787B2 (en) | 2002-04-19 | 2011-05-10 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8636673B2 (en) | 2002-04-19 | 2014-01-28 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9186468B2 (en) | 2002-04-19 | 2015-11-17 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7914465B2 (en) | 2002-04-19 | 2011-03-29 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US9089678B2 (en) | 2002-04-19 | 2015-07-28 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US9089294B2 (en) | 2002-04-19 | 2015-07-28 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
US7909777B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc | Method and apparatus for penetrating tissue |
US7909774B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8690796B2 (en) | 2002-04-19 | 2014-04-08 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7909778B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US9072842B2 (en) | 2002-04-19 | 2015-07-07 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8202231B2 (en) | 2002-04-19 | 2012-06-19 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7901362B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8784335B2 (en) | 2002-04-19 | 2014-07-22 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling device with a capacitive sensor |
US8808201B2 (en) | 2002-04-19 | 2014-08-19 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for penetrating tissue |
US7875047B2 (en) | 2002-04-19 | 2011-01-25 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with sterility barrier release |
US7892183B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US8845549B2 (en) | 2002-04-19 | 2014-09-30 | Sanofi-Aventis Deutschland Gmbh | Method for penetrating tissue |
US8905945B2 (en) | 2002-04-19 | 2014-12-09 | Dominique M. Freeman | Method and apparatus for penetrating tissue |
US7731900B2 (en) | 2002-11-26 | 2010-06-08 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US8383041B2 (en) | 2002-12-23 | 2013-02-26 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US8021631B2 (en) | 2002-12-23 | 2011-09-20 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US8574496B2 (en) | 2002-12-23 | 2013-11-05 | Roche Diagnostics Operations, Inc. | Body fluid testing device |
US8574895B2 (en) | 2002-12-30 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
US9034639B2 (en) | 2002-12-30 | 2015-05-19 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
US8262614B2 (en) | 2003-05-30 | 2012-09-11 | Pelikan Technologies, Inc. | Method and apparatus for fluid injection |
US8251921B2 (en) | 2003-06-06 | 2012-08-28 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
US9144401B2 (en) | 2003-06-11 | 2015-09-29 | Sanofi-Aventis Deutschland Gmbh | Low pain penetrating member |
US10034628B2 (en) | 2003-06-11 | 2018-07-31 | Sanofi-Aventis Deutschland Gmbh | Low pain penetrating member |
US8282576B2 (en) | 2003-09-29 | 2012-10-09 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for an improved sample capture device |
US8945910B2 (en) | 2003-09-29 | 2015-02-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for an improved sample capture device |
US9351680B2 (en) | 2003-10-14 | 2016-05-31 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a variable user interface |
US8668656B2 (en) | 2003-12-31 | 2014-03-11 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for improving fluidic flow and sample capture |
US9561000B2 (en) | 2003-12-31 | 2017-02-07 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for improving fluidic flow and sample capture |
US8296918B2 (en) | 2003-12-31 | 2012-10-30 | Sanofi-Aventis Deutschland Gmbh | Method of manufacturing a fluid sampling device with improved analyte detecting member configuration |
US9261476B2 (en) | 2004-05-20 | 2016-02-16 | Sanofi Sa | Printable hydrogel for biosensors |
US8828203B2 (en) | 2004-05-20 | 2014-09-09 | Sanofi-Aventis Deutschland Gmbh | Printable hydrogels for biosensors |
US9775553B2 (en) | 2004-06-03 | 2017-10-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
US9820684B2 (en) | 2004-06-03 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
US8652831B2 (en) | 2004-12-30 | 2014-02-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte measurement test time |
US8880138B2 (en) * | 2005-09-30 | 2014-11-04 | Abbott Diabetes Care Inc. | Device for channeling fluid and methods of use |
US7927290B2 (en) | 2006-01-05 | 2011-04-19 | Panasonic Corporation | Blood test apparatus |
US20110160614A1 (en) * | 2006-01-05 | 2011-06-30 | Panasonic Corporation | Blood test apparatus |
US20090281455A1 (en) * | 2006-01-05 | 2009-11-12 | Matsushita Electric Industrial Co., Ltd. | Blood test apparatus |
US9844329B2 (en) | 2006-02-28 | 2017-12-19 | Abbott Diabetes Care Inc. | Analyte sensors and methods of use |
US9031630B2 (en) | 2006-02-28 | 2015-05-12 | Abbott Diabetes Care Inc. | Analyte sensors and methods of use |
US8414504B2 (en) | 2006-03-22 | 2013-04-09 | Panasonic Corporation | Blood test device |
US8500655B2 (en) | 2006-03-22 | 2013-08-06 | Panasonic Corporation | Blood test apparatus and method of controlling the same |
US20110237978A1 (en) * | 2006-03-22 | 2011-09-29 | Panasonic Corporation | Blood test apparatus and method of controlling the same |
US7976478B2 (en) | 2006-03-22 | 2011-07-12 | Panasonic Corporation | Blood test apparatus and method of controlling the same |
US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
US20080139903A1 (en) * | 2006-12-08 | 2008-06-12 | Isense Corporation | Method and apparatus for insertion of a sensor using an introducer |
US20090099437A1 (en) * | 2007-10-11 | 2009-04-16 | Vadim Yuzhakov | Lancing Depth Adjustment Via Moving Cap |
WO2009048687A1 (en) * | 2007-10-11 | 2009-04-16 | Abbott Diabetes Care, Inc. | Lancing depth adjustment via moving cap |
US9386944B2 (en) | 2008-04-11 | 2016-07-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte detecting device |
US11621073B2 (en) | 2008-07-14 | 2023-04-04 | Abbott Diabetes Care Inc. | Closed loop control system interface and methods |
US10328201B2 (en) | 2008-07-14 | 2019-06-25 | Abbott Diabetes Care Inc. | Closed loop control system interface and methods |
US8876755B2 (en) | 2008-07-14 | 2014-11-04 | Abbott Diabetes Care Inc. | Closed loop control system interface and methods |
US20100056954A1 (en) * | 2008-09-02 | 2010-03-04 | Eli Oren | Device For Extracting Blood Samples |
US9375169B2 (en) | 2009-01-30 | 2016-06-28 | Sanofi-Aventis Deutschland Gmbh | Cam drive for managing disposable penetrating member actions with a single motor and motor and control system |
US9795326B2 (en) | 2009-07-23 | 2017-10-24 | Abbott Diabetes Care Inc. | Continuous analyte measurement systems and systems and methods for implanting them |
US10827954B2 (en) | 2009-07-23 | 2020-11-10 | Abbott Diabetes Care Inc. | Continuous analyte measurement systems and systems and methods for implanting them |
US8965476B2 (en) | 2010-04-16 | 2015-02-24 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US9795747B2 (en) | 2010-06-02 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
Also Published As
Publication number | Publication date |
---|---|
US6063039A (en) | 2000-05-16 |
US6283926B1 (en) | 2001-09-04 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6283926B1 (en) | Method and apparatus for obtaining blood for diagnostic tests | |
US6306104B1 (en) | Method and apparatus for obtaining blood for diagnostic tests | |
US6155992A (en) | Method and apparatus for obtaining interstitial fluid for diagnostic tests | |
US6506168B1 (en) | Apparatus and method for obtaining blood for diagnostic tests | |
US7247144B2 (en) | Methods and apparatus for sampling and analyzing body fluid | |
AU2001264976A1 (en) | Apparatus and method for obtaining blood for diagnostic tests | |
US20200405235A1 (en) | Inspection chip and inspection device | |
JP2004522500A5 (en) | ||
AU774042B2 (en) | Method and apparatus for obtaining blood for diagnostic tests | |
MXPA99005239A (en) | Method and apparatus for obtaining blood for diagnostic tests |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCF | Information on status: patent grant |
Free format text: PATENTED CASE |
|
CC | Certificate of correction | ||
FPAY | Fee payment |
Year of fee payment: 4 |
|
FPAY | Fee payment |
Year of fee payment: 8 |
|
FPAY | Fee payment |
Year of fee payment: 12 |