Body fluid lancing, acquiring, and testing cartridge design
First Claim
Patent Images
1. A disposable device for analyzing body fluid, comprising:
- a container which can be inserted into a measuring apparatus, the container having a disk-like configuration and containing a plurality of sampling members formed as a lancet wheel, each of the sampling members having a proximal body portion and a distal skin piercing tip extending at an angle from the proximal body portion to form a contact portion between the proximal body portion and the distal skin piercing tip, the proximal body portion attached to a rim of the lancet wheel, the distal skin piercing tip configured to pierce skin of a body part, and the contact portion disposed at a bend between the proximal body portion and the distal skin piercing tip configured for transfer of a body fluid sample;
a plurality of test members corresponding to the plurality of sampling members for receiving body fluid obtained by the skin-piercing, wherein the plurality of test members are fixed in a plurality of retaining chambers of the container; and
wherein each of the sampling members is configured to move from an initial state wherein the sampling member does not contact the test member to a skin-piercing state wherein the sampling member rotates away from the test member to form an incision in skin, and further wherein each of the sampling members is configured to move from the skin-piercing state to a transfer state wherein the sampling member rotates towards the test member so that the contact portion is in fluidic connection with the test member to transfer body fluid after the skin-piercing.
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Abstract
A disposable device for analyzing body fluid especially for blood sugar tests includes a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing. In one form, the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.
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Citations
49 Claims
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1. A disposable device for analyzing body fluid, comprising:
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a container which can be inserted into a measuring apparatus, the container having a disk-like configuration and containing a plurality of sampling members formed as a lancet wheel, each of the sampling members having a proximal body portion and a distal skin piercing tip extending at an angle from the proximal body portion to form a contact portion between the proximal body portion and the distal skin piercing tip, the proximal body portion attached to a rim of the lancet wheel, the distal skin piercing tip configured to pierce skin of a body part, and the contact portion disposed at a bend between the proximal body portion and the distal skin piercing tip configured for transfer of a body fluid sample; a plurality of test members corresponding to the plurality of sampling members for receiving body fluid obtained by the skin-piercing, wherein the plurality of test members are fixed in a plurality of retaining chambers of the container; and wherein each of the sampling members is configured to move from an initial state wherein the sampling member does not contact the test member to a skin-piercing state wherein the sampling member rotates away from the test member to form an incision in skin, and further wherein each of the sampling members is configured to move from the skin-piercing state to a transfer state wherein the sampling member rotates towards the test member so that the contact portion is in fluidic connection with the test member to transfer body fluid after the skin-piercing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. An apparatus, comprising:
an integrated cartridge having drop-in assembly of components, including a test ring component having a plurality of test sections; a lancet wheel component having a lancet rim with a plurality of lancets extending radially inward from the lancet rim, each of the lancets having a leg portion and a lancet tip extending substantially transverse to the leg portion to form a curved contact portion therebetween wherein the curved contact portion is in fluidic connection with the lancet tip, wherein the curved contact portion is configured to contact one of the plurality of test sections to deposit a body fluid sample on the test section; and a frame component having an egg crate shape with a plurality of chambers to facilitate drop-in assembly of the lancet wheel component onto the frame component. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. A method, comprising:
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assembling an integrated disposable cartridge, wherein said assembling includes dropping a lancet wheel into a circular frame, the lancet wheel having a rim with a plurality of radially inwardly extending lancets, each of the lancets having a leg portion and a lancet tip extending at an angle from the leg portion to form a contact portion between the leg portion and the lancet tip, wherein the contact portion is in fluidic connection with the lancet tip and is configured to contact a test section to deposit a body fluid sample on the test section, the frame having a plurality of spokes defining a plurality of chambers; positioning each of the lancets in one of the chambers; attaching a test ring having a continuous strip of chemistry onto the frame; and sectioning the test ring into a plurality of test sections by the plurality of spokes, each of the test sections positioned under one of the lancets such that each of the lancets is configured to rotate away from the test section to form an incision. - View Dependent Claims (36, 37, 38, 39)
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40. A method, comprising:
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providing an integrated disposable cartridge including a frame, a lancet wheel having a plurality of lancets extending radially inward from a rim, and a test ring having a plurality of test sections, each of the plurality of lancets has a lancet tip that extends at an angle from a leg portion to define a contact portion between the lancet tip and the leg portion, the lancet tip having a capillary groove that extends to the contact portion, wherein the contact portions are configured to contact the plurality of test sections; forming an incision in tissue with one of the lancets by rotating the lancet away from the plurality of test sections; collecting a body fluid sample with the capillary groove on the lancet; withdrawing the lancet from the incision in tissue by rotating the lancet towards the plurality of test sections; and transferring the body fluid sample from the capillary groove on the lancet to one of the test sections by contacting the test section with the contact portion of the lancet to release the body fluid sample. - View Dependent Claims (41, 42, 43)
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44. An apparatus, comprising:
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an integrated cartridge having drop-in assembly of components, including a lancet wheel component having a lancet rim with a plurality of lancets extending radially inward from the lancet rim, each of the lancets having means for forming an incision in skin and means for transferring a body fluid sample to a test element, a frame component having an egg crate shape with a plurality of chambers to facilitate drop-in assembly of the lancet wheel component onto the frame component, a test ring component having a continuous strip of chemistry that spans a circumference of the test ring component, the test ring component being sectionable into a plurality of test elements, and wherein the plurality of chambers are configured to section the test ring component into the plurality of test elements and each of the lancets is positioned next to one test element such that the means for transferring the body fluid sample is in fluidic contact with the one test element to deposit the body fluid sample. - View Dependent Claims (45, 46, 47, 48)
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49. An apparatus, comprising:
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an integrated cartridge having drop-in assembly of components, including a lancet wheel component having a plurality of lancets, each of the lancets having a leg portion and a lancet tip extending substantially transverse to the leg portion to form a contact portion therebetween, and a frame component having a plurality of chambers to facilitate drop-in assembly of the lancet wheel component onto the frame component; a test ring component having a continuous strip of chemistry that spans a circumference of the test ring component, the test ring being sectionable into a plurality of test sections, wherein the plurality of chambers are configured to section the test ring component into the plurality of test sections and each of the lancets is positioned next to one test section; and wherein the leg portion is resilient to move between a first position wherein the lancet tip forms an incision and a second position wherein the contact portion is in fluidic connection with the test section to deposit a body fluid sample.
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Specification