Tissue penetration device

• US 20090131829A1
• Filed: 12/16/2008
• Published: 05/21/2009
• 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
• Granted Patent: US 9,339,612 B2
• Time in Patent Office: Days
• 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 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 method for creating a puncture wound in the epidermis of a body part to obtain a body fluid sample, comprising:

creating a skin opening in the epidermis at a puncture site to a first depth without reaching blood carrying tissue during a skin-opening step;

allowing the epidermis at the puncture site to relax; and

inserting a penetrating member into the skin opening to a second depth that reaches blood carrying tissue to create a puncture wound for collecting the body fluid sample during a sample collection step.

2. The method of claim 1, wherein the penetrating member is decelerated at an end of the skin-opening step and then accelerated again in the sample collection step.

3. The method of claim 2, wherein the penetrating member is stopped at the end of the skin-opening step.

4. The method of claim 3, wherein the penetrating member is retracted at the end of the skin-opening step.

5. The method of claim 4, wherein the penetrating member is completely withdrawn from the epidermis at the end of the skin-opening step.

6. The method of claim 1, further comprising:

after inserting the penetrating member into the skin opening to the second depth, retracting the penetrating member into a collection position where a tip of the penetrating member remains within the skin.

7. The method of claim 6, further comprising:

decelerating the penetrating member as it approaches the collection position.

8. A method of using a penetrating member apparatus to create a puncture wound in an epidermis of a body part to obtain a body fluid sample, the penetrating member apparatus including a penetrating member, a drive for reciprocating the penetrating member, and a housing having an opening from which the penetrating member is accessible for contacting a body part the method comprising:

(a) contacting the apparatus with a body part from which a body fluid sample is to be obtained;

(b) advancing the penetrating member to a first distance relative to the apparatus and create a skin opening in the epidermis with a first depth that does not reach blood carrying tissue;

(c) allowing the epidermis around the skin opening to relax; and

(d) advancing the penetrating member a second distance into the skin opening to a second depth that reaches blood carrying tissue and create a puncture wound for collecting the body fluid sample.

9. The method of claim 8, wherein the first distance is less than the second distance.

10. The method of claim 8, further comprising:

after step (b) retracting the penetrating member.

11. The method of claim 8, further comprising:

after step (b) completely withdrawing the penetrating member from the body part.

12. The method of claim 8, further comprising;

after step (d) retracting the penetrating member into a collection position where a tip of the penetrating member remains within the skin.

13. The method of claim 12, further comprising:

decelerating the penetrating member as it approaches the collection position.

14. A handheld apparatus for creating a puncture wound, comprising:

a penetrating member;

a drive for moving the penetrating member toward and away from a skin surface;

a control device for controlling the movement of the penetrating member, the control device being operable to, (i) move the penetrating member in a skin opening step a first distance toward the skin to create a skin opening, slow or pause movement of the penetrating member for a sufficient time to allow the epidermis at a puncture site to relax, and (iii) move the penetrating member toward the skin a second distance and create a puncture wound for collecting a body fluid sample.

15. The apparatus of claim 14, wherein the control device is operable to retract the penetrating member before moving the penetrating member toward the skin the second distance.

16. The apparatus of claim 14, further comprising:

a housing with a housing opening associated with a pressure ring for contacting a body part in which a puncture wound is to be created