Devices for physiological fluid sampling and methds of using the same

• US 20050113717A1
• Filed: 11/22/2004
• Published: 05/26/2005
• Est. Priority Date: 10/10/2001
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: ASM NuTool, Inc. (ASM International NV)
• Inventors: Matzinger, David, Quraishi, Khalid R.
• Granted Patent: US 7,070,564 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/441 : Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/489 : Blood vessels
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/80 : involving blood groups or blood types or red blood cells white blood cells G01N33/56972

Abstract

Methods and devices are provided for determining a suitable site for sampling physiological fluid. In the subject methods, a potentially suitable physiological sampling site is selected, the fluid flow of the site is characterized and the site is then determined to be suitable based on the whether the site has high or low flow. Suitability may also be determined based on the type of sample obtainable from the site, where the order of the above-described steps may be altered. The subject devices include at least one site flow characterization element for determining the flow characteristics of a potential physiological sampling site and/or at least one sample type characterization element for determining whether the vasculature is arterial, venous or neither, i.e., an interstitial fluid sampling site. The subject methods and devices are particularly suited for use in the detection of physiological sampling sites in the fingers, arms, legs, earlobes, heels, feet, nose and toes. Also provided are kits that include the subject devices for use in practicing the subject methods.

Claims

1-108. -108. (canceled)

109. A method for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said method comprising the steps of:

(a) contacting a potentially suitable site with a device configured to determine the type of physiological fluid at said potentially suitable site;

(b) determining the type of physiological fluid at said potentially suitable site; and

(c) determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on said determined fluid type.

110. The method according to claim 109, wherein said step of determining the type of physiological fluid at said potentially suitable site comprises characterizing the pulse of said potentially suitable site.

111. The method according to claim 110, wherein the step of characterizing the pulse of said site comprises characterizing the red blood cells of said physiological fluid at said potentially suitable site.

112. The method according to claim 111, wherein the step of characterizing red blood cells comprises characterizing red blood cell flux.

113. The method according to claim 109, wherein said step of determining the type of physiological fluid at said potentially suitable site comprises characterizing the hemoglobin of the physiological fluid at said potentially suitable site.

114. The method according to claim 113, wherein the step of characterizing the hemoglobin comprises determining the hemoglobin concentration of said physiological fluid at said potentially suitable site.

115. The method according to claim 113, wherein the step of characterizing the hemoglobin comprises determining the concentration of the oxygenated hemoglobin and deoxygenated hemoglobin.

116. The method according to claim 113, wherein the step of characterizing the hemoglobin comprises determining the ratio of oxygenated hemoglobin to deoxygenated hemoglobin.

117. The method according to claim 109, further comprising the step of characterizing the flow of physiological fluid at said potentially suitable.

118. The method according to claim 117, wherein said step of characterizing the flow comprises determining the temperature at said potentially suitable site.

119. The method according to claim 117, wherein said step of characterizing the flow comprises characterizing the red blood cells of said physiological fluid at said potentially suitable site.

120. The method according to claim 109, further comprising the step of accessing said physiological fluid at said site.

121. The method according to claim 120, further comprising the step of stimulating the site to enhance the volume of physiological fluid expressed from said site.

122. The method according to claim 120, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

123. The method according to claim 122, wherein said concentration determination comprises transferring a volume of said physiological sample to an analyte concentration test strip.

124. The method according to claim 122, wherein said at least one analyte is glucose and said physiological sample is blood.

125. The method according to claim 122, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

126. The method according to claim 122, wherein an automated meter performs said concentration determination automatically.