Method for penetrating tissue

• US 8,845,549 B2
• Filed: 12/02/2008
• Issued: 09/30/2014
• 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:
  US12/326,698
• Publication Number:
  US 20090112123A1
• Time in Patent Office: 2,128 Days
• Field of Search: 600/573, 600575-579, 600/583, 606181-183
• US Class Current: 600/583
• 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 method for a system for withdrawing body fluid from a body part via a withdrawal site, comprising:

depressing skin at the withdrawal site with a penetrating member of a system for withdrawing body fluid in a direction toward a surface of the skin;

measuring an amount of elastic tenting of skin of the body part as the penetrating member depresses the skin in a direction toward a surface of the skin to determine elasticity of the skin;

storing the amount of elastic tenting of the skin in a processor of the system for withdrawing body fluid;

selecting a driver profile from a set of alternative driver profiles stored in the processor of the system for withdrawing body fluid;

penetrating the skin by driving the penetrating member in accordance with the selected driver profile;

settling at a depth setting that depends on the measured amount of elastic tenting of the skin for a certain period of dwell time that is related to the measured amount of elastic tenting of the skin before starting to withdraw from the withdrawal site; and

withdrawing body fluid from the body part via the withdrawal site.

2. The method of claim 1, wherein selecting a setting includes determining at least one of the penetrating member position and acceleration.

3. A method for withdrawing body fluid from a body part via a withdrawal site, comprising:

depressing skin at the withdrawal site with a penetrating member of an analyte measurement device in a direction toward a surface of the skin;

measuring an amount of elastic tenting of skin of the body part as the penetrating member depresses the skin during a number of prior body fluid withdrawals, the elastic skin tenting being in a direction toward a surface of the skin;

storing the amount of elastic tenting of the skin in a processor of the analyte measurement device;

selecting a driver profile from a set of alternative driver profiles stored in the processor of the analyte measurement device;

creating a puncture wound in the skin by driving the penetrating member, in accordance to the driver profile selected from the processor of the analyte measurement device, to a depth setting that depends on the measured amount of elastic tenting of the skin, for a period of dwell time that is related to the measured amount of elastic tenting of the skin; and

withdrawing body fluid from the puncture wound and into the analyte measurement device.

4. The method of claim 3, wherein at least one of the following settings is selected from the processor:

blocking or releasing of a penetrating member;

setting a puncture or brake depth of a penetrating member selected for creating an opening in the body;

setting a geometric shape of a press-on area of the analyte measurement device;

setting a cross section of an opening in a press-on area of the analyte measurement device, through which opening a penetrating member can penetrate into a surface of a body part;

selecting one of at least two press-on areas included in the analyte measurement device;

selecting one of at least two penetrating members contained in the analyte measurement device;

setting a duration of a withdrawal procedure;

displaying text on a display device; and

displaying or setting evaluation parameters which are used for analyzing body fluid.

5. The method of claim 3, further comprising:

providing an audio output of a glucose measurement.

6. The method of claim 3, wherein a depth of penetration of a penetrating member is 100 to 2500 microns.

7. The method of claim 3, wherein a depth of penetration of a penetrating member is 500 to 750 microns.

8. The method of claim 3, further comprising:

using a feedback loop coupled to a processor.

9. The method of claim 3, wherein in a first direction a penetrating member moves toward a target tissue at a speed that is different than a speed at which the penetrating member moves away from the target tissue.

10. The method of claim 3, wherein in a first direction a penetrating member moves toward a target tissue at a speed that is greater than a speed at which the penetrating member moves away from the target tissue.

11. The method of claim 9, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

12. The method of claim 9, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

13. The method of claim 9, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

14. The method of claim 9, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

15. The method of claim 3, wherein a dwell time of a penetrating member in a target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

16. The method of claim 3, wherein a dwell time of a penetrating member in a target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

17. The method of claim 3, wherein a dwell time of a penetrating member in a target tissue below a skin, surface is in the range of 100 milliseconds to 1 second.