Method and apparatus for penetrating tissue

• US 9,724,021 B2
• Filed: 12/08/2014
• Issued: 08/08/2017
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Boecker, Dirk, Alden, Don
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US14/563,833
• Publication Number:
  US 20150313515A1
• Time in Patent Office: 974 Days
• Field of Search: 600573, 600575, 600576, 600583, 600584, 606167, 606171, 606172, 606181, 606182, 606183
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150152 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 5/150221 Valves
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15113 : 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 5/15123 : comprising magnets or solenoids
• 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 5/15169 : 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 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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: G01N 27/28 : Electrolytic cell components
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Claims

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

a controllable drive force generator;

a plurality of penetrating members operatively coupled to said controllable drive force generator, each of a penetrating member of the plurality of penetrating members at least partially positioned adjacent to an analyte detecting member in a sample chamber, the sample chamber configured to receive body fluid from a wound in tissue created by each of a penetrating member of the plurality of penetrating member, and the analyte detecting member being configured to determine at least one analyte level using a body fluid sample of less than about 1 microliter;

a feedback loop coupled to a processor, the processor storing controllable drive force generator profiles in a memory, the processor configured to select a controllable drive force generator profile from a set of alternative controllable drive force generator profiles based on a controllable drive force generator performance, the processor configured to modify a selected controllable drive force generator profile and in response modulate a power from a power supply to the controllable drive force generator to provide a controllable velocity trajectory for each of a penetrating member of the plurality of penetrating members into the tissue site and out of the tissue site, the processor configured to monitor position and speed of each of a penetrating member of the plurality of penetrating members as it moves in a first direction to and through the target tissue site;

a support member with a surface that carries the plurality of penetrating members, said support member being movable to move each of a penetrating member of the plurality of penetrating members to a launch position associated with said controllable drive force generator.

2. The system of claim 1, further comprising a plurality of analyte detecting members positioned to receive body fluid.

3. The system of claim 1, wherein:

the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 microliter of the body fluid.

4. The system of claim 1, wherein:

the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 microliter of the body fluid.

5. The system of claim 1, wherein:

the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 microliter of the body fluid.

6. The system of claim 1, wherein:

the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 microliter of the body fluid.

7. The system of claim 1, wherein:

the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 microliter of a body fluid disposed in the sample chamber.

8. The system of claim 1, wherein the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 microliter of a body fluid disposed in the sample chamber.

9. The system of claim 1, wherein the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 microliter of a body fluid disposed in the sample chamber.

10. The system of claim 1, wherein the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 microliter of a body fluid disposed in the sample chamber.

11. The system of claim 1, wherein the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 microliter of a body fluid disposed in the sample chamber.

12. The system of claim 1, wherein each of a penetrating member of the plurality of penetrating members is an elongate member without molded attachments.

13. The system of claim 1,

wherein a penetrating member exit is configured to be positioned against the tissue site when each of a penetrating member of the plurality of penetrating members contacts the tissue site.