Method and apparatus for penetrating tissue

• US 9,907,502 B2
• Filed: 12/16/2008
• Issued: 03/06/2018
• 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, Alden, Don
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US12/335,760
• Publication Number:
  US 20090124932A1
• Time in Patent Office: 3,367 Days
• Field of Search: 600573, 600575-579, 600583, 606181-183
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 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 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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 5/15184 : 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 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6886 : Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61M 5/3295 : Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

Abstract

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims

1. A puncturing system for generating a puncture wound for obtaining a sample of a body fluid from a tissue site, comprising:

a housing of the puncturing system;

a penetrating member positioned in the housing of the puncturing system;

a penetrating member driver positioned in the housing;

a coupler configured to engage at least a portion of the penetrating member in order to drive the penetrating member along a path into and through target tissue and then withdraw from the target tissue;

a body fluid analyte sensor in the housing configured to determine at least one test parameter of a body fluid;

a processor in the housing with a memory coupled to the penetrating member driver, the processor including the memory, the processor configured to select a penetrating member driver profile from a set of alternative penetrating member driver profiles based on a desired tissue penetration device performance with the processor customizing the penetrating member profile based on additional user input information, wherein the processor selects a penetrating member driver profile for setting penetration parameters of a penetrating member to create the puncture wound for a successful penetration to achieve a desired body fluid volume, the processor configured to modulate power from a power supply to the penetrating member driver through an amplifier, each penetrating member driver profile stored in the memory; and

a user interface comprising a cellular telephone interface at the housing in communication with the processor, the user interface further including an audio device positioned in the housing, wherein the audio device provides analysis information to the user and receives audio commands from the user, the user interface additionally including a sensor for detecting audio commands.

2. The system of claim 1, wherein the body fluid sensor is an analyte detecting member that detects glucose.

3. A method for using a puncturing device for producing a puncture wound to obtain a body fluid sample, comprising:

providing the puncturing device comprising a housing for the puncturing device and a penetrating member driver;

pressing a tissue interface surface of the housing of the puncturing device against a tissue site to be punctured;

storing, using a processor positioned in the housing, a set of alternative velocity profiles of the penetrating member driver, the set of alternative velocity profiles being stored in a non-volatile memory included in the housing,

generating one or more alarms that provide a user with reminders to take a measure of the body fluid using a user interface that includes a cellular telephone interface at the housing in communication with the processor;

prompting a user of the puncturing device to input information about a desired circumstance or parameter for a lancing event;

obtaining user audio commands with a sensor at the user interface of the puncturing device;

selecting, using the processor, a velocity profiles of the penetrating member driver from the set of alternative velocity profiles of the penetrating member driver based on a desired tissue penetration;

customizing, using the processor, the selected velocity profiles of the penetrating member driver based on additional user input information;

modulating, using the processor, power from a power supply to the penetrating member driver through an amplifier to follow the customized velocity profile to produce a puncture wound to obtain a body fluid using a penetrating member positioned in the housing; and

,

providing at least one output to a user selected from at least one of;

number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue, force delivered on a target tissue, energy used by a penetrating member driver to drive a penetrating member into target tissue, dwell time of a penetrating member, battery status of the system, status of the system, and a speed profile of a penetrating member.

4. The method of claim 3, further comprising detecting one or more analytes found in a body fluid.