Method and apparatus for penetrating tissue

• US 20070043305A1
• Filed: 10/19/2006
• Published: 02/22/2007
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique
• GRANTED PATENT: US 8,007,446 B2
• Time in patent office: 0 Days
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• 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 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F13/0059; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A body fluid sampling system for use on a tissue site has a housing and a penetrating member driver at least partially within the housing. At least one cartridge is in the housing. The cartridge includes an analyte sensor in a sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member. A penetrating member is associated with the sample chamber. Each penetrating member, and its associated sample chamber, has a combined occupied volume of no more than about 5.0 cm³. The penetrating member is at least partially co-located with the analyte sensor in the sample chamber. The sample chamber receives body fluid from a wound in tissue created by a penetrating member, and the analyte sensor determines analyte levels using a body fluid sample of less than about 1 microliter. A transport mechanism engages the cartridge. The penetrating member is operatively engaged with the penetrating member driver when moved into position by the transport mechanism. The driver provides the force to advance the penetrating member. A user interface on the housing displays information to a user.

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil based penetrating member driver;

a plurality of cartridges;

a plurality of penetrating members, each of a penetrating member and its associated sample chamber having a combined occupied volume of no more than about 5.0 cm³;

a transport mechanism configured to engage said cartridges, wherein each of said cartridges are operatively engaged with said penetrating member driver when moved into position by said transport mechanism; and

a human interface providing at least one output.

2. The system of claim 1, further comprising:

a processor coupled to the penetrating member driver and configured to change a direction and magnitude of force exerted on a penetrating member as it penetrates or advances through the target tissue.

3. The system of claim 1, further comprising:

a penetrating member sensor configured to detect a penetrating member position during target tissue penetration.

4. The system of claim 1, wherein the at least one output is selected from, a penetration event of a penetrating member, number of penetrating members remaining, time of day, alarm, penetrating member trajectory waveform profile information, force for last penetration event, the last penetration event, how or low battery status, analyte status, time to change cassette status, jamming malfunction, and system status.

5. The system of claim 1, wherein the human interface is selected from an LED, an LED digital display, an LCD display, a sound generator, a buzzer, and a vibrating device.

6. The system of claim 1, wherein the housing is selected from at least one of, a telephone, a watch, a PDA, electronic device, medical device, point of care device and a decentralized diagnostic device.

7. The system of claim 1, further comprising:

an input device coupled to the housing, the input device selected from one or more pushbuttons, a touch pad independent of the display device, or a touch sensitive screen on a visual display.

8. The system of claim 1, further comprising:

a data exchange device for coupling the tissue penetrating system to support equipment.

9. The system of claim 8, further comprising:

a data interface configured to couple the tissue penetrating system to support equipment with a data interface.

10. The system of claim 1, further comprising:

a data exchange device for coupling the tissue penetrating system to support equipment selected from one of the following;

personal computer, modem, PDA and a computer network.

11. The system of claim 1, wherein the human interface includes a real time clock and one or more alarms a user can set for reminders of when a next target tissue penetration event is needed.

12. The system of claim 1, wherein the human interface is coupled to receive signals from a human interface processor separate from a processor coupled to the penetrating member driver.

13. The system of claim 12, wherein the human interface processor has a sleep mode and runs intermittently to conserve power.

14. The system of claim 1, further comprising:

a memory for storing at least one of, a number of penetrating members used, number of target tissue penetrating events, time and date of the last selected number of target tissue penetrating events, time interval between alarm and target tissue penetrating event, stratum corneum thickness, time of day, energy consumed by a penetrating member driver to drive a penetrating member into the target tissue, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, a target tissue relaxation parameter, force delivered on the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue, a tissue target tissue relaxation parameter, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue, information relative to consumed sensors and information relative to consumed penetrating members.

15. The system of claim 8, wherein the human interface processor has logic that provides an alarm time set for a first subset of days and a second alarm time set for a second subset of days.

16. The system of claim 110, wherein the first subset of days is Monday thru Friday and the second subset of days is Saturday and Sunday.

17. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil based penetrating member driver;

a plurality of cartridges;

a plurality of penetrating members, each of a penetrating member and its associated sample chamber having a combined occupied volume of no more than about 5.0 cm³;

a transport mechanism configured to engage said cartridges, wherein each of said cartridges are operatively engaged with said penetrating member driver when moved into position by said transport mechanism; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

18. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil based penetrating member driver;

a plurality of cartridges;

a plurality of penetrating members, each of a penetrating member and its associated sample chamber having a combined occupied volume of no more than about 5.0 cm³;

a transport mechanism configured to engage said cartridges, wherein each of said cartridges are operatively engaged with said penetrating member driver when moved into position by said transport mechanism; and

a human interface providing at least one output.

19. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion 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; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

20. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion 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; and

a human interface providing at least one output.

21. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

22. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; and

a human interface providing at least one output.

23. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

24. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and

a human interface providing at least one output.

25. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 tissue stabilizer device suitable for stretching a surface of a tissue site, said stabilizer at least partially surrounding the penetrating member exit; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

26. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 tissue stabilizer device suitable for stretching a surface of a tissue site, said tissue stabilizer at least partially surrounding the penetrating member exit; and

a human interface providing at least one output.

27. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 pressure applicator coupled to the housing; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

28. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 pressure applicator coupled to the housing;

a tissue stabilizer device suitable for stretching a surface of a tissue site, said tissue stabilizer at least partially surrounding the penetrating member exit; and

a human interface providing at least one output.

29. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 μ

L of the fluid; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

30. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 μ

L of the fluid; and

a human interface providing at least one output.

31. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 μ

L of the fluid; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

32. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil 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 μ

L of the fluid; and

a human interface providing at least one output.