Tissue penetration device

• US 20090138032A1
• Filed: 12/01/2008
• Published: 05/28/2009
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Alden, Don, Freeman, Dominique, Briggs, Barry Dean
• Granted Patent: US 8,636,673 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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: A61M 37/0015 : by using microneedles

Abstract

A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Claims

1. A body fluid collection system, comprising:

a housing with a body fluid sample chamber and a sample transport channel;

a penetrating member with a sharpened tip and positioned within the housing;

a tissue penetration depth selection device configured to provide a desired penetration depth of the penetrating member below a skin surface; and

a penetrating member driver configured to be coupled to the penetrating member, drive the penetrating member along a movement path to penetrate a skin surface in a first direction during a penetration phase, and withdraw the penetrating member in an opposing second direction during a retraction phase, wherein the penetrating member driver drives the penetrating member through the skin surface to a defined puncture depth and remain below the skin surface for a sufficient time for a body fluid sample to be collected during a collection phase at the body fluid sample chamber and a sample transport channel.

2. The system of claim 1, wherein the tissue penetration depth selection device is adapted for setting a mean value of a defined residual puncturing depth independently of the defined puncturing depth.

3. The system according claim 1, wherein the penetrating member driver is adapted for controlling, as a further movement phase, a further retraction phase, in which the piercing element is accelerated again and withdrawn completely from the skin.

4. The system of claim 1, wherein the system includes a retraction stop to provide that the penetrating member is stopped at the defined residual puncturing depth at the end of the retraction phase.

5. The system of claim 1, further comprising:

a reference element configured o contacting the skin surface and provide a reproducible defined puncturing depth during piercing.

6. The system of claim 5, wherein the penetrating member is moved together with the reference element.

7. The system of claim 1, wherein a position of the skin is detected prior to launch of the penetrating member.

8. The system of claim 1, wherein the penetrating member driver includes an actuator spring.

9. The system of claim 8, further comprising:

a penetrating member driver sleeve and a penetrating member plunger sleeve.

10. The system of claim 9, wherein the penetrating member driver sleeve, penetrating member plunger sleeve, and actuator spring move outward together until a plunger head contacts a bottom of a counterbore 651 at an end of a preload screw.

11. A body fluid collection system, comprising:

a sample collection unit that includes body fluid sample chamber and a sample transport channel;

a penetrating member holder for holding the sample collection unit;

a drive for driving the lancet holder through a piercing and retraction movement; and

a damping mechanism coupled to the lancet holder to damp deceleration of the lancet holder toward an end of the retraction movement.

12. The system of claim 11, wherein advancement and retraction profiles of the penetrating member through the skin are used to minimize pain, success of receiving a body fluid sample, and a spontaneous generation of the body fluid to the fluid transport channel and sample chamber.

13. The system of claim 11, wherein the housing includes an ergonomically contoured sampling area.

14. The system of claim 11, further comprising:

a sensor that activates the penetrating member driver, causing the penetrating member to pierce a skin surface and allow a blood fluid sample to be flow and be collected in the body fluid sample chamber and sample transport channel.

15. The system of claim 11, wherein sample body fluid is acquired and transported to the body fluid sample chamber without substantial contamination by ambient air.

16. The system of claim 11, wherein the advancement, retraction and collection phases are configured to provide for spontaneous body fluid generation.

17. The system of claim 11, wherein a velocity of the penetrating member in the advancement phase is greater than a velocity of the penetrating member in the retraction phase to provide for an improved success rate of a wound channel remaining open for the free passage of body fluid to a surface of the skin.

18. The system of claim 11, wherein a speed of the penetrating member is controlled and compensates for changes in skin thickness and variations in skin hydration to achieve spontaneous body fluid yield with while minimizing pain.

19. The system of claim 11, wherein the penetrating member driver is mechanically driven.

20. The system of claim 11, wherein the penetrating member driver is electronically driven.

21. The system of claim 11, wherein the damping mechanism is a mechanical stop for the penetrating member with energy transferred to the mechanical stop being minimized.

22. The system of claim 11, wherein velocities of the penetrating during the advancement and retraction phases are selected to reduce pain.

23. The system of claim 12, wherein the retraction phase occurs following sectioning of venuole/capillary mesh and provides for a free flow of body fluid to a surface of the skin.

25. A method of obtaining a body fluid sample, comprising:

(a) an introduction phase when a penetrating member is advanced from a stationary position towards a skin surface;

(b) a tissue contact phase when the distal end of the penetrating member makes initial contact with the skin surface;

(c) a tissue deformation phase when the skin surface bends depending on its elastic properties;

(d) a tissue lancing phase when the penetrating member hits an inflection point on the skin and begins to cut the skin surface and advance through tissue adjacent to the skin surface;

(e) a penetrating member rest phase that is a limit of penetration by the penetrating member into the skin; and

(f) a penetrating member retraction phase, wherein an average velocity of the penetrating member during the tissue lancing phase is greater than an average velocity of the penetrating member during the penetrating member retraction phase.

24. The system of claim 27, wherein the lower velocity of the retraction phase reduces the occurrence of a skin wound flap creating by the penetrating member from sealing.

26. The method of claim 25, wherein a success rate of body fluid collection is increased by measuring an exact depth of penetration from inflection point to the limit of penetration in the lancet rest phase.

27. The method of claim 26, wherein the measuring the exact depth of penetration always the penetrating member to reliably hit capillary beds that are a known distance underneath the surface of the skin.

28. The method of claim 25, wherein the lancet retraction phase further comprises:

a primary retraction phase when the skin pushes the penetrating member out of a wound tract, a secondary retraction phase when the penetrating member begins to become dislodged and pulls in an opposite direction of the skin, and a penetrating member exit phase when the penetrating member becomes free of the skin.

29. The method of claim 25, wherein body fluid volume is increased by using a uniform velocity to retract the penetrating member during the penetrating member retraction phase.

30. The method of claim 25, wherein the introduction phase includes a penetrating member launch phase when the penetrating member is longitudinally moving through air toward the skin.

31. The method of claim 25, wherein during the tissue deformation phase the skin bends depending on its elastic properties which are related to hydration and thickness.

32. The method of claim 25, wherein pain is reduced by minimizing a duration of the penetrating member introduction phase to provide that a fast incision to a certain penetration depth is created regardless of a duration of the deformation phase and the inflection point cutting which varies from user to user.

33. The method of claim 25, wherein body fluid collection is increased by measuring an exact depth of penetration from the inflection point to a limit of penetration in the penetrating member rest phase.

34. The method of claim 33, wherein measurement of the exact depth of penetrating provides for the penetrating member to reliably access capillary beds which are a known distance underneath the surface of the skin.

35. The method of claim 25, wherein the penetrating member includes a primary retraction phase when the skin pushes the penetrating member out of a wound tract, a secondary retraction phase when the penetrating member becomes dislodged and pulls in an opposite direction relative to the skin, and a penetrating member exit phase when the penetrating member becomes free of the skin.

36. The method of claim 35, wherein the primary retraction phase is a result of exerting a decreasing force to pull the penetrating member out of the skin as the penetrating member pulls away from the finger.

37. The method of claim 36, wherein the secondary retraction phase is a result of exerting a force in an opposite direction to dislodge the penetrating member.

38. The method of claim 37, wherein body fluid volume is increased by applying a uniform velocity to retract the penetrating member during the penetrating member retraction phase regardless of force required for the primary retraction phase or the secondary retraction phase, wherein the first and primary and secondary retraction phases vary from user to user in response to the user'"'"'s skin.