METHODS AND APPARATUS FOR SAMPLING AND ANALYZING BODY FLUID
First Claim
1. A method of collecting a bodily fluid sample from an incision in the skin comprising:
- pressing against the skin a stimulator sleeve of a bodily fluid sampling device around the incision to express the bodily fluid sample; and
moving a capillary tube of the bodily fluid sampling device towards the incision by moving the capillary tube relative to the stimulator sleeve while the sleeve remains in contact with the skin.
4 Assignments
0 Petitions
Accused Products
Abstract
A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.
114 Citations
78 Claims
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1. A method of collecting a bodily fluid sample from an incision in the skin comprising:
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pressing against the skin a stimulator sleeve of a bodily fluid sampling device around the incision to express the bodily fluid sample; and
moving a capillary tube of the bodily fluid sampling device towards the incision by moving the capillary tube relative to the stimulator sleeve while the sleeve remains in contact with the skin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of collecting a sample of bodily fluid from an incision in the skin, comprising:
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pressing against the skin a stimulator sleeve of a bodily fluid sampling device around the incision to express at least a drop of the bodily fluid; and
moving a means for collecting the bodily fluid in the bodily fluid sampling device towards the drop by moving the means for collecting the bodily fluid relative to the stimulator sleeve while the sleeve remains in contact with the skin. - View Dependent Claims (11, 12, 13)
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14. A sampling module comprising:
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a module body portion having a sampling site adjacent a lancet exit port where the sharpened distal tip of the lancet exits a distal end of the module body portion that includes a sample cavity in a distal end surface of the module body portion;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion and extendable from the lancet exit port; and
a sample reservoir in fluid communication with a sample cavity of the module body portion. - View Dependent Claims (15, 16)
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17. A tissue penetrating system, comprising:
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a penetrating member driver;
a cartridge with a distal port and a proximal port and coupled to the penetrating member driver;
an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of a body fluid disposed in the sample chamber;
a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the sample chamber; and
a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting. - View Dependent Claims (18)
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19. A tissue penetrating system, comprising:
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a penetrating member driver;
a cartridge with a distal port and a proximal port and coupled to the penetrating member driver;
an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of a body fluid disposed in the sample chamber;
a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the sample chamber; and
a human interface providing at least one output. - View Dependent Claims (20, 21, 22, 23, 24)
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25. A skin penetrating system, comprising:
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a housing member;
a penetrating member positioned in the housing member, and an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of a body fluid disposed in the sample chamber, wherein a tip of the penetrating member is configured to extend through an opening of the sample chamber. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33)
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34. A tissue penetrating system, comprising:
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a penetrating member driver;
a cartridge with a distal port and a proximal port and coupled to the penetrating member driver;
an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of a body fluid disposed in the sample chamber; and
a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the sample chamber. - View Dependent Claims (35)
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36. A method of penetrating a target tissue, comprising:
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providing a tissue penetrating system with a penetrating member and an analyte detecting member coupled to a sample chamber;
advancing a penetrating member through the target tissue;
withdrawing the penetrating member from the target tissue;
receiving a body fluid in the sample chamber. - View Dependent Claims (37)
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38. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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39. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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40. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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41. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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42. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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43. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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44. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment. a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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45. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment. a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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46. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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47. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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48. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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49. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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50. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
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51. A method of obtaining a sample of capillary whole blood from a target tissue, comprising
providing a penetrating system that includes a tissue stabilizing member; -
applying skin stimulation to a skin surface site with the tissue stabilizing member;
introducing a penetrating member through the skin surface site to form an incision; and
collecting blood from the incision in the penetrating system. - View Dependent Claims (52)
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53. A tissue penetrating device, comprising:
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a housing;
at least one penetrating member a penetrating member driver coupled to the at least one penetrating member;
a tissue stabilizer member coupled to the housing; and
a human interface providing at least one output. - View Dependent Claims (54, 55, 56, 57, 58)
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59. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment. a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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60. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid;
a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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61. A method comprising:
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providing a penetrating member driver;
installing a visual display on said penetrating member driver where said display when coupled to a processor, relays penetrating member information selected from;
lancing performance or lancing setting.
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62. A method comprising:
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providing a lancet driver;
installing a visual display on said lancet driver where said display when coupled to a processor, relays lancet information selected from;
lancing performance or lancing setting.
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63. A skin penetrating system, comprising:
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a housing member;
a penetrating members positioned in the housing member, and a tissue stabilizing device coupled to the housing member.
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64. A skin penetrating system, comprising:
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a housing member;
a penetrating member positioned in the housing member, and a tissue pressure applicator coupled to the housing member. - View Dependent Claims (70)
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65. A method for sampling body fluids from a patient, the method comprising:
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using a human interface on a lancet driver to communicate information to the patient;
actuating said lancet driver to drive a lancet into the patient in a manner sufficient to obtain said body fluid sample. - View Dependent Claims (66, 67, 68, 69)
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71. A device for determining the concentration of an analyte in a physiological sample, said device comprising:
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(a) a housing having an aperture;
(b) a lancing element having a lancet held therein disposed within said housing;
(c) means for activating said lancing element to displace said lancet through said aperture to provide an incision in an area of skin to provide physiological sample at the surface of said incised area of skin; and
(d) means for determining whether a sufficient amount of said physiological sample is present at the surface of said incised area of skin for analyte concentration determination. - View Dependent Claims (72, 73, 74, 75, 76, 77, 78)
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Specification