Blood and interstitial fluid sampling device
First Claim
1. A sampling module, comprising:
- a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and
a sample reservoir in fluid communication with a sample input port of the module body portion.
3 Assignments
0 Petitions
Accused Products
Abstract
A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.
-
Citations
92 Claims
-
1. A sampling module, comprising:
-
a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and
a sample reservoir in fluid communication with a sample input port of the module body portion. - View Dependent Claims (2, 3, 4)
-
-
5. A sampling module, comprising:
-
a module body portion comprising a lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;
a sample reservoir having an input end and a terminal end, the sample reservoir being in fluid communication with a sample input port of the module body portion; and
a vent disposed between and in fluid communication with the terminal end of the sample reservoir and the lancet channel. - View Dependent Claims (6, 7)
-
-
8. A sampling module comprising:
-
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 (9, 10)
-
-
11. A sampling module, comprising:
-
a module body portion comprising a lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;
a first sample reservoir having an input end and a terminal end, the input end of the sample reservoir being in fluid communication with a sample input port of the module body portion; and
a second sample reservoir having an input end in fluid communication with the terminal end of the first sample reservoir and having a cross sectional area that is substantially smaller than a cross sectional area of the first sample reservoir such that a sample flowing from the sample input port into the first sample reservoir will fill the first sample reservoir and then rapidly fill the second sample reservoir by capillary action.
-
- 12. A method for sampling blood comprising lancing to create a wound tract and bracing the wound tract.
-
14. A lancet module comprising
a module body portion configured to be mechanically registered and secured adjacent a lancet driver; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion. - View Dependent Claims (15, 16)
- and
- 17. A lancet module comprising a module body portion having a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel.
-
20. A sampling module comprising:
-
a module body portion configured to be mechanically registered and secured adjacent a lancet driver;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and
a sample reservoir in fluid communication with a sampling site of the module body portion. - View Dependent Claims (21, 22, 23)
-
-
24. A sampling module comprising:
-
a module body portion;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within a lancet channel of the module body portion; and
a sample reservoir which has an analytical region with sample sensors disposed within the analytical region the sample reservoir being in fluid communication with a sampling site of the module body portion.
-
- 25. A sampling module comprising a module body portion having a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.
-
32. A sampling device comprising:
-
a lancet for obtaining a blood sample from a user, said lancet having a distal end and a proximal end;
a reservoir for collecting the blood sample adjacent to the distal end of said lancet;
a lancet driver attached to the proximal end of said lancet; and
a sensor on said sampling device for detecting said user and initiating a lancing cycle. - View Dependent Claims (33, 34, 35, 36, 37)
-
-
38. A method of sampling comprising:
-
providing a sampling module having a lancet disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;
coupling the lancet of the sampling module to a lancet driver;
activating a lancing cycle by having a patient place target tissue over a sensor which detects the target tissue and initiates the lancing cycle;
lancing the target tissue to obtain a sample of blood;
collecting said sample of blood through the orifice. - View Dependent Claims (39)
-
-
40. A method of sampling comprising:
-
loading a disposable sampling module into a lancing device with a lancet disposal within a lancet channel which has an orifice on a surface of said sampling module;
initiating a lancing cycle by prompting a user sensor on said lancing device;
activating said lancing cycle by having a patient place a finger over an ergonomically contoured area located on said surface such that said finger overlaps with said orifice;
lancing the finger to obtain a sample of blood;
collecting said sample of blood through said orifice; and
informing said user to remove said finger from the ergonomically contoured active sampling area. - View Dependent Claims (41)
-
-
42. A method of sampling comprising:
-
loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample; and
collecting said blood sample. - View Dependent Claims (43)
-
-
44. A method of sampling comprising:
-
loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample;
collecting said blood sample; and
. - View Dependent Claims (45, 46, 47, 48)
-
-
49. A tissue penetration sampling device for collecting blood from the skin of a patient, the device comprising:
-
a sampling module having a sampling site, the sampling site having a sample input port, a sample reservoir in fluid communication with the sample input port, a lancet maintained within the sampling module, the lancet having a lancet tip adjacent the sample input port, and a lancet driver coupled to the lancet to drive the lancet tip through the opening to lance the skin when the lancet driver is actuated, the device being configured to allow actuation of the lancet driver, lancing of the skin, collection of the blood, and movement of the blood to the sample reservoir seamlessly by forming a substantially airtight seal at the opening when the skin is firmly pressed against the sampling site. - View Dependent Claims (50)
-
-
51. A sampling module for use in collecting blood from the skin of a patient, comprising
a body portion, a sampling site on the body portion defining a sample input port, the sampling site shaped to conform to the skin and to form a substantially airtight seal with the skin, a lancet disposed in the body portion, the lancet having a lancet tip adjacent the sample input port, wherein the lancet is operable to send the lancet tip through the opening to lance the skin of the patient, and a reservoir in fluid communication with the sample input port, the sampling acquisition module configured to allow seamless sampling of the blood, and integrated lancing of the skin, collection of the blood through the sample input port, and movement of the blood to the sample reservoir.
-
52. A method of collecting blood from the skin of a patient, the method comprising:
-
a) contacting the skin of the patient with a blood sampling device, and b) performing a single initiating act resulting in the blood sampling device lancing the skin, collecting blood from the skin, and moving blood to a reservoir within the sampling device. - View Dependent Claims (53, 54, 55)
-
-
56. A tissue penetrating system, comprising:
-
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 (82)
-
-
57. A tissue penetrating system, comprising:
-
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 (58, 59, 60, 61, 83)
-
-
62. A skin penetrating system, comprising:
-
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 (63, 64, 65, 66, 67, 68, 69, 70, 84)
-
-
71. A tissue penetrating system, comprising:
-
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 (85)
-
-
72. A method of penetrating a target tissue, comprising:
-
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 (86)
-
-
73. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
74. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
75. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
76. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
77. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
78. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
79. A tissue penetrating device, comprising:
-
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 (80)
-
-
81. A body fluid sampling system for use on a tissue site, the system comprising:
-
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.
-
-
87. A method for sampling body fluids from a patient, the method comprising:
-
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 (88, 89, 90)
-
-
91. A skin penetrating system, comprising:
-
a housing member;
a penetrating member positioned in the housing member, and a tissue pressure applicator coupled to the housing member. - View Dependent Claims (92)
-
Specification