Blood sampling device

• US 20040230216A1
• Filed: 12/12/2003
• Published: 11/18/2004
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Facet Technologies LLC
• Original Assignee: Facet Technologies LLC
• Inventors: Ostertag, Wolfgang, Ruf, Christopher J., Kennedy, Gwenn E., Heath, Jason R., Solis, Mitchell, Lohrengel, Armin, Robbins, Avi M., Stohr, Herbert, Levaughn, Richard W.
• Granted Patent: US 7,150,755 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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. (Cancelled).

69. A lancet cartridge for a lancing device comprising:

a plurality of lancets, each lancet comprising a protective cap;

a carrier retaining said plurality of lancets in a plane and defining a path of travel within the plane for each of said plurality of lancets;

at least one guide member in engagement with the protective cap of each of said plurality of lancets; and

a spring biasing the protective cap of each of said plurality of lancets out of the plane.

70. The lancet cartridge of claim 69, wherein the protective cap of each lancet comprises a pair of recesses on opposed sides thereof, and wherein the carrier comprises a guide member engaged in each of said recesses to constrain the protective cap to motion along a path out of said plane.

71. The lancet cartridge of claim 70, wherein the carrier comprises a recess for receiving the protective cap of each of said plurality of lancets upon separation of the cap from the lancet and retaining said protective cap out of the path of travel of the lancet.

72. The lancet cartridge of claim 69, wherein the carrier comprises a pair of upright walls bounding the sides of each of said plurality of lancets to define the path of travel of the lancets.

73. The lancet cartridge of claim 69, wherein each spring comprises a loop having a pair of legs and a cross-member extending between the legs, said cross-member engaging the protective cap of each of said plurality of lancets.

74. The lancet cartridge of claim 69, wherein the carrier is a generally circular disk, and wherein the plurality of lancets are arranged generally radially about the perimeter of the carrier.

75. The lancet cartridge of claim 69, wherein each lancet comprises at least one cantilevered spring element for engagement with said carrier to bias the lancet toward a retracted position.

76. A lancet cartridge comprising:

at least one lancet having a protective cap removably mounted thereon, said at least one lancet constrained to a generally linear path of travel;

a spring for biasing the protective cap of each lancet out of the path of travel upon separation of the protective cap from the lancet.

77. The lancet cartridge of claim 76, further comprising at least one guide member in engagement with the protective cap to guide the protective cap out of the path of travel of the lancet under the influence of the spring.

78. The lancet cartridge of claim 76, wherein said spring comprises a flat section in engagement with the protective cap of each said lancet.

79. The lancet cartridge of claim 76, wherein each lancet is slidably mounted on a carrier, said carrier comprising walls defining a path of travel for each lancet.

80. The lancet cartridge of claim 79, wherein each spring comprises a generally U-shaped member having a pair of legs straddling said walls, and a cross-member extending between the pair of legs, and wherein the path of travel of each lancet extends through said generally U-shaped member.

81. The lancet cartridge of claim 79, wherein each lancet comprises a resilient tongue for engagement with said carrier to bias the lancet toward a retracted position.

82. The lancet cartridge of claim 79, wherein the carrier is a generally circular disk, and wherein the plurality of lancets are arranged generally radially about a central axis of the disk.

83. A lancet cartridge for replaceable insertion in a lancing device, said cassette comprising:

a disk-shaped carrier having a first face comprising a series of teeth for cooperative engagement with an advancing mechanism of the lancing device and a second face comprising walls defining a plurality of radial paths; and

a plurality of lancets, each lancet translationally mounted in one of said radial paths.

84. The lancet cartridge of claim 83, further comprising a spring for biasing a separable endcap portion of each lancet out of a plane defined by the plurality of radial paths.

85. The lancet cartridge of claim 84, wherein the separable endcap portion of each lancet defines at least one groove extending along a side face thereof, and wherein said carrier comprises a guide member in engagement with each said groove to guide the end cap in a direction generally perpendicular to the plane defined by the plurality of radial paths upon separation of said end cap from the lancet.

86. The lancet cartridge of claim 83, further comprising a cantilevered arm comprising a locating finger for alignment within a cartridge alignment recess of the lancing device.

87. The lancet cartridge of claim 83, further comprising a cartridge stop for preventing re-use of the plurality of lancets.

88. The lancet cartridge of claim 83, wherein said series of engagement teeth permit advancement in a first direction and prevent advancement in a second direction opposite the first direction.

89. A method of obtaining a sample of body fluid using a lancing device, said method comprising:

cocking the lancing device to engage a first lancet with a drive mechanism, arm the drive mechanism, separate a protective cap from said first lancet, and remove the protective cap from a path of travel of the first lancet; and

actuating the lancing device to drive the first lancet along the path of travel.

90. The method of claim 89, further comprising again cocking the lancing device to engage a second lancet with the drive mechanism, arm the drive mechanism, separate a protective cap from said second lancet, and remove the protective cap from a path of travel of the second lancet.