Method and apparatus for penetrating tissue

• US 9,795,334 B2
• Filed: 07/09/2007
• Issued: 10/24/2017
• 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, Hegener, Jason
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/774,778
• Publication Number:
  US 20080021491A1
• Time in Patent Office: 3,760 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 positioned in the housing member and a plurality of sample chambers. Each sample chamber is associated with a penetrating member. A tissue stabilizing member has a tissue interface surface configured to be applied to a tissue surface and provide for spontaneous flow of blood for sample capture. The tissue stabilizing member is coupled to the housing.

Claims

1. A tissue penetrating device, comprising:

a housing member;

an electronic penetrating member driver positioned in the housing member a plurality of penetrating members positioned in the housing member,

each penetrating member coupled to and driven by the electronic penetrating member driver;

a first processor coupled to the electronic penetrating member driver and to a feedback loop, the first processor storing penetrating member driver profiles in a memory, selecting a penetrating member driver profile from a set of alternative driver profiles based on a desired tissue penetration performance, and modifying an electronic penetrating member driver profile based on additional user input information, the first processor configured to modulate power from a power supply to the electronic penetrating member driver in response to a modification of the electronic penetrating member driver profile;

a plurality of sample chambers positioned in the housing member, each sample chamber associated with a penetrating member;

an interface coupled with the first processor coupled to a second processor, the second processor including a sleep mode and can run intermittently to conserve power, the second processor providing an alarm time set;

a real time clock coupled to one or more alarms to provide a user with a reminder of a next penetrating event; and

an interface surface that is coupled to the housing member.

2. The device of claim 1, wherein the interface surface includes a tissue stabilizing member to cause at least a portion of the tissue surface to press in an inward direction relative to the housing member.

3. The device of claim 2, wherein the interface surface is configured to enhance fluid flow from a wound created below the tissue surface.

4. The device of claim 2, wherein the interface surface is configured to stretch the tissue surface.

5. The device of claim 2, wherein the interface surface is configured to apply a force to the tissue surface.

6. The device of claim 2, wherein the interface surface is configured to be positioned to at least partially surround an impact location of the penetrating member on the tissue surface.

7. The device of claim 2, wherein the interface surface is a stimulating member.

8. The device of claim 1, further comprising:

a vacuum source configured to assist creation of a low pressure environment in the interface surface or along a fluid path to a sample chamber.

9. The device of claim 1, wherein each sample chamber has a volume no greater than 1 μ

L.

10. The device of claim 1, wherein in a first direction each of the penetrating members moves toward the tissue surface at a speed that is different than a speed at which each of the penetrating members moves away from the tissue surface.

11. The device of claim 1, wherein in a first direction each penetrating member moves toward the tissue surface at a speed that is greater than a speed at which the penetrating member moves away from the tissue surface.

12. The device of claim 10, wherein a speed of a penetrating member in the first direction towards is the range of 0.05 to 60 m/sec.

13. The device of claim 10, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

14. The device of claim 10, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

15. The device of claim 1, wherein further comprising:

an interface coupled to the clock.

16. The device of claim 1, wherein in a first direction the penetrating member driver moves each penetrating member toward the tissue surface at a speed that is different than a speed at which each of the penetrating members moves away from the tissue surface.

17. The device of claim 1, wherein in a first direction each penetrating member moves by the penetrating member driver towards the tissue surface at a speed that is greater than a speed at which the penetrating member moves away from the tissue surface.

18. The device of claim 17, wherein a speed of a penetrating member in the first direction towards is the range of 0.05 to 60 m/sec.

19. The device of claim 17, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

20. The device of claim 17, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.