Method and apparatus for multi-use body fluid sampling device with sterility barrier release

• US 20080300614A1
• Filed: 05/27/2008
• Published: 12/04/2008
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Cane, Mike, Alden, Don, Freeman, Dominique M., Schumann, Matt, Beadman, Miko
• Granted Patent: US 8,388,551 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 device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

Claims

1. A multi-lancet cartridge, comprising:

a disk-shaped cartridge housing;

a driver positioned in the disk-shaped cartridge housing;

a disk-shaped carrier rotationally received in the cartridge housing;

a plurality of penetrating members carried by the carrier, each of a penetrating member having a lancet body and a lancet tip extending from the body, each of a penetrating member being configured to be coupled to a,

an advancement device configured to move the disk shaped carrier in a rotational movement in preparation of placing a lancet in an active position for being launched to a tissue site;

at least one penetrating member sterility barrier that provides a sterile environment for a tip of a penetrating member;

a device that removes the at least one penetrating member sterility barrier out of a path of travel from the penetrating member upon launch of the penetrating member while at the active position.

2. The cartridge of claim 1, wherein the penetrating members are radially arranged on the carrier.

3. The cartridge of claim 1, wherein the cartridge housing has a single penetrating member opening that defines the active penetrating member position, wherein the tip of the active-positioned penetrating member extends through the single penetrating member opening during its launch stroke.

4. The cartridge of claim 3, wherein the penetrating members are radially arranged on the carrier and the cartridge housing has an outer circumferential rim with the single penetrating member opening defined therein.

5. The cartridge of claim 4, wherein the cartridge housing has a radial launch channel that receives and guides the active-positioned penetrating member in its launch stroke, wherein the radial launch channel and the single penetrating member opening are aligned and cooperatively define the active penetrating member position.

6. The cartridge of claim 1, wherein the cartridge housing has a radial launch channel that receives and guides the active-positioned penetrating member in its launch stroke, wherein the radial launch channel defines the active penetrating member position.

7. The cartridge of claim 1, wherein the penetrating members and the carrier have cooperating engagement surfaces that prevent the penetrating members from moving radially except when in the active penetrating member position.

8. The cartridge of claim 7, wherein the cooperating engagement surfaces include a foot on each of the penetrating members and a circular foot channel defined by the cartridge housing that engages the feet of the penetrating members.

9. The cartridge of claim 8, wherein the cartridge housing has a radial launch channel that receives and guides the active-positioned penetrating member in its launch stroke, wherein the radial launch channel defines the active penetrating member position, and wherein the radial launch channel extends through the circular foot channel to permit the active-positioned penetrating member to move radially in its launch stroke.

10. The cartridge of claim 1, wherein the carrier has an array of radial guide channels that receive and guide the penetrating members in their launch strokes when the penetrating members are sequentially advanced into the active position.

11. A multi-penetrating member cartridge for use with and replaceable in a launch device having an advancer mechanism and a drive mechanism, comprising:

a disk-shaped cartridge housing having a radial launch channel and an outer circumferential rim with a single penetrating member opening therein, the radial launch channel and the single penetrating member opening are aligned and cooperatively define an active penetrating member position;

a disk-shaped carrier rotationally received in the cartridge shell; and

a radial array of penetrating members carried by the carrier, each of a penetrating member having a penetrating member body and a penetrating member tip extending from the body, wherein the carrier is engageable and moveable by the advancer mechanism to rotate the carrier of penetrating members within the cartridge housing to sequentially advance the penetrating members into an active penetrating member position, and wherein an active one of the penetrating members in the active position is engageable and movable by the drive mechanism and guided by the radial launch channel through a launch stroke from a retracted position to an extended position with the penetrating member tip extending through the single penetrating member opening in the cartridge housing to lance skin.

12. The launch device of claim 11, wherein the penetrating members and the carrier have cooperating engagement surfaces that prevent the penetrating members from moving radially except when in the active penetrating member position.

13. The launch device of claim 11, wherein the cartridge housing and the penetrating member carrier have cooperating mechanical stop surfaces that prevent the carrier from rotating more than one complete revolution to prevent reuse of the penetrating members.