BLOOD SAMPLING DEVICE

• US 20070088377A1
• Filed: 12/18/2006
• Published: 04/19/2007
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Facet Technologies LLC
• Original Assignee: Facet Technologies LLC
• Inventors: LeVAUGHN, Richard, RUF, Christopher, ROBBINS, Avi, SOLIS, Mitchell, KENNEDY, Gwenn, HEATH, Jason, STOHR, Herbert, LOHRENGEL, Armin, OSTERTAG, Wolfgang
• Granted Patent: US 8,870,903 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• 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 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices

Abstract

A device for sampling and/or analyzing blood or other body fluid of a subject. A housing contains a plurality of lancets and optionally includes test elements to take up a sample of blood, an evaluation system and a display. A complete system that can be handled as a single device, for example in the form of a wristwatch, includes a multiplicity of test elements and lancets, which can be brought successively to a working position to perform multiple measurements. A cassette or carrier includes multiple lancets and/or test elements, for insertion into the device.

Claims

1-68. -68. (canceled)

69. A testing device comprising:

a housing; and

a cartridge mountable within the housing, said cartridge comprising a plurality of lancets and a plurality of test elements.

70. The testing device of claim 69, wherein the housing comprises a generally circular disk.

71. The testing device of claim 70, wherein the housing further comprises a wristband, and wherein the generally circular disk has the appearance of a wristwatch.

72. The testing device of claim 69, wherein the housing is openable and the cartridge is replaceable therein.

73. The testing device of claim 69, further comprising an analysis device for evaluating an analyte of a body fluid.

74. The testing device of claim 73, wherein the analysis device is a blood-sugar meter.

75. The testing device of claim 73, further comprising a display.

76. The testing device of claim 75, wherein the display is switchable between a time display for use as a watch, and an analyte display associated with the analysis device for use as a blood-sugar meter.

77. The testing device of claim 69, wherein the lancets are arranged in a generally circular array in the cartridge and wherein each lancet comprises a needle oriented generally radially within the circular array.

78. The testing device of claim 77, wherein the circular array comprises an open position with no lancet, and a positioning indicator at the open position for assisting in replacement of the cartridge within the housing.

79. The testing device of claim 69, wherein at least one spring is associated with each of the plurality of lancets.

80. The testing device of claim 69, further comprising an advancing mechanism for sequential use of the plurality of lancets and the plurality of test elements.

81. The testing device of claim 69, further comprising a sensor for triggering the device upon contact with a subject'"'"'s skin.

82. A cartridge for use in a testing device, the cartridge comprising:

a plurality of lancet needles; and

a plurality of test elements.

83. The cartridge of claim 82, further comprising a carrier for mounting the cartridge to the testing device.

84. The cartridge of claim 82, wherein the cartridge is generally circular.

85. The cartridge of claim 82, wherein each of the plurality of lancet needles is generally radially oriented.

86. The cartridge of claim 82, wherein each of the plurality of test elements comprise electrical contacts.

87. A cartridge for use in a testing device, the cartridge comprising:

a plurality of movably mounted lancet needles; and

a carrier allowing the cartridge to be mounted to the testing device.

88. The cartridge of claim 87, wherein the plurality of movably mounted lancet needles are generally radially oriented and arranged in a ring on the carrier.

89. A lancing device comprising:

at least one lancet having a lancet cap covering a sharp lancet tip;

decapping means for separating the lancet cap from the lancet tip;

cap displacement means for moving the lancet cap out of a path of travel of the lancet; and

cap retention means for securing the removed lancet cap within the lancing device.

90. The lancing device of claim 89, comprising a plurality of lancets arranged in a planar array, wherein the path of travel of the lancet lies in the plane of said planar array, and wherein the cap displacement means moves the lancet cap transverse to the plane of said planar array.

91. The lancing device of claim 90, wherein the plurality of lancets are contained in a replaceable cartridge, said cartridge comprising the cap retention means.

92. The lancing device of claim 89, further comprising an actuator for initiating operation of both the decapping means and the cap displacement means.

93. A lancing device comprising:

a housing for receiving a cartridge containing a plurality of lancets;

a drive mechanism for sequentially engaging each of the plurality of lancets; and

an actuator operable through an actuation stroke, wherein an advancing portion of the actuation stroke advances the plurality of lancets for sequential engagement with the drive mechanism, and wherein a charging portion of the actuation stroke energizes the drive mechanism.

94. The lancing device of claim 93, wherein each of the plurality of lancets comprises a removable cap, and wherein the charging portion of the actuation stroke decaps one of the plurality of lancets.

95. The lancing device of claim 93, wherein the actuator comprises at least one cam path.

96. A lancing device comprising:

a housing for receiving a cartridge containing a plurality of lancets arranged in a planar array; and

a drive mechanism for sequentially engaging each of the plurality of lancets, wherein the drive mechanism comprises a plunger for driving an active one of the lancets through a lancing stroke, said plunger being co-planarly aligned with the planar array of lancets.

97. The lancing device of claim 96, wherein the drive mechanism further comprises a drive spring also co-planarly aligned with the planar array of lancets.

98. The lancing device of claim 97, wherein the drive mechanism further comprises a return spring also co-planarly aligned with the planar array of lancets.

99. The lancing device of claim 96, wherein the plunger of the drive mechanism comprises an open receiver jaw in the plane of the array of lancets.

100. A lancing device comprising a drive mechanism for sequentially engaging lancets of a multi-lancet array, each of the lancets of the multi-lancet array having an engagement portion, and the drive mechanism comprising a drive plunger defining an open channel extending therethrough for receiving the engagement portion of an active lancet of the multi-lancet array.

101. The lancing device of claim 100, wherein the engagement portion comprises a projection extending laterally from a rear end of each lancet.

102. A lancing device comprising:

an outer shell;

a carrier disk rotationally mounted within the outer shell, and defining a plurality of guide paths; and

a plurality of lancets, each lancet translationally mounted within a corresponding one of the plurality of guidepaths.

103. The lancing device of claim 102, wherein the carrier disk further defines a plurality of cap-removal paths, each cap removal path extending generally perpendicularly to a corresponding one of the plurality of guidepaths.