Tissue penetration device

• US 20090131965A1
• Filed: 12/16/2008
• Published: 05/21/2009
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Alden, Don, Freeman, Dominique
• Granted Patent: US 8,337,421 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150427 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 5/151 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 5/15146 : 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

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 penetrating member system for withdrawing body fluid from a body part, comprising:

a penetrating member with a tip;

a sterile protector that surrounds the tip, the sterile protector having a weakened portion along which the sterile protector at least partially separates during a puncture movement, and

wherein the tip is released to perform a puncture.

2. The penetrating member system of claim 1, further comprising:

a housing for reciprocally housing the penetrating member, the housing having an opening through which the tip is exposed for puncture during a puncture movement of the penetrating member.

3. The penetrating member system of claim 2, wherein the tip extends from the opening during a puncture movement and retracts into the opening after the puncture movement.

4. The penetrating member system of claim 2, wherein the sterile protector at least partially separates when the sterile protector engages an inner surface of the housing.

5. The penetrating member system of claim 1, wherein the weakened portion extends lengthwise along the sterile protector and is oriented substantially parallel to the tip.

6. The penetrating member system of claim 1, wherein the sterile protector divides into sub regions that protrude away from the tip after the sterile protector at least partially separates along the weakened portion.

7. The penetrating member system of claim 6, wherein the sub regions remain connected to the sterile protector during the puncture movement.

8. The penetrating member system of claim 1, wherein the sterile protector is a substantially cylindrical cap.

9. The penetrating member system of claim 1, wherein the penetrating member is a needle with the tip, the needle being at least partially surrounded by a penetrating member body.

10. The penetrating member system of claim 1, wherein the sterile protector is displaced away from the tip during the puncture movement.

11. The penetrating member system of claim 10, wherein the sterile protector slides along the penetrating member during the puncture movement.

12. The penetrating member system of claim 1, wherein the weakened portion has a plurality of weakened portions.

13. The penetrating member system of claim 1, wherein the weakened portion has a groove along which the sterile protector at least partially separates during a puncture movement.

14. A penetrating member system for pricking a body part and withdrawing body fluid, comprising:

a magazine including a plurality of chambers;

a plurality of penetrating members, one of a penetrating member being movably mounted in an associated chamber, each of a penetrating member including a tip and a sterile protector that surrounds the tip, the sterile protector having a weakened portion along which the sterile protector at least partially separates during a puncture movement; and

wherein the tip is released to perform a puncture.

15. The magazine of claim 14, wherein each chamber includes a first opening configured for receiving a driving actuator.

16. The magazine of claim 14, wherein during a puncture movement the sterile protector engages an inner surface of the chamber to cause the sterile protector to at least partially separate at the weakened portion.

17. The magazine of claim 14, wherein each chamber includes an outlet through which the tip extends during a puncture movement and through which the tip retracts into the chamber after the puncture movement.

18. The magazine of claim 14, wherein the sterile protector divides into sub-regions that protrude away from the tip after the sterile protector at least partially separates along the weakened portion.

19. The magazine of claim 18, wherein the sub-regions remain connected to the sterile protector during the puncture movement.

20. The magazine of claim 14, wherein the sterile protector is displaced away from the tip during the puncture movement.

21. The magazine of claim 20, wherein the sterile protector slides along the penetrating member during the puncture movement.

22. A method for pricking a body part with a penetrating member system that includes a housing with opening, a penetrating member moveably disposed in the housing, and a sterile protector surrounding a tip of the penetrating member, the sterile protector having a weakened portion, the method comprising:

positioning the opening on or near the body part;

moving the penetrating member toward the opening during a puncture movement until the sterile protector contacts an inner surface of the housing near the opening;

at least partially separating the sterile protector along the weakened portion;

driving the tip through the sterile protector; and

puncturing the body part.

23. The method of claim 22, wherein during the separating step the sterile protector divides into sub-regions.

24. The method of claim 23, further comprising:

preventing the sub-regions from detaching from the sterile protector.

25. The method of claim 23, further comprising:

moving the sub-regions away from the tip as the weakened portion at least partially separates.

26. The method of claim 25, wherein after the separating step the friction between the needle and the sterile protector is reduced.

27. The method of claim 22, wherein after the separating step a portion of the sterile protector surrounds at least part of the penetrating member.

28. The method of claim 22, further comprising:

moving the sterile protector relative to the tip during the puncture movement.

29. The method of claim 28, wherein the moving step includes sliding the sterile protector along the penetrating member and away from the tip.

30. A penetrating member system, comprising:

a housing with an opening;

a penetrating member with a tip and positioned in the housing, the tip configured to puncture a body part during a puncturing operation;

a sterile protector with a weakened portion; and

wherein the penetrating member is moveable between a first position and a second position, in the first position the tip being positioned within the housing and enclosed by the sterile protector, in the second position the tip being exposed through the opening and the sterile protector being at least partially separated along the weakened portion.

31. The penetrating member system of claim 30, wherein the sterile protector is a substantially cylindrical cap.

32. The penetrating member system of claim 30, wherein the sterile protector has a first end section and a second end section, the second end section including the weakened portion.

33. The penetrating member system of claim 32, wherein in the second position, the first end section circumscribes the penetrating member.

34. The penetrating member system of claim 32, wherein in the second position, the second end section remains attached to the first end section.

35. The penetrating member system of claim 32, wherein as the tip moves from the first position to the second position, the second end section engages an inner surface of the housing and at least partially separates along the weakened portion.

36. The penetrating member system of claim 35, wherein as the second end section at least partially separates along the weakened portion, the second end section divides into sub-regions that protrude away from the tip.

37. The penetrating member system of claim 35, wherein after the second end section engages the inner surface of the housing, the sterile protector moves relative to the tip.

38. The penetrating member system of claim 37, wherein the sterile protector slides relative to the tip.

39. The penetrating member system of claim 30, wherein in the second position, the sterile protector has sub-regions that protrude away from the tip.