Method and apparatus for penetrating tissue

• US 8,366,637 B2
• Filed: 12/03/2008
• Issued: 02/05/2013
• 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, Alden, Don
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/326,962
• Publication Number:
  US 20090112124A1
• Time in Patent Office: 1,525 Days
• Field of Search: 600/573, 600/575, 600/576, 600/583, 600/584, 600/300, 600/306, 600/577, 600/578, 606/181, 606/182, 606/183, 128/920, 128/923, 700/301, 700/302, 700/303, 700/304, 702/1, 702/19, 702/127, 702/138, 702/139, 702/150, 702/152, 702/189
• US Class Current: 600/584
• 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 skin penetrating system is provided with a drive force generator and a disposable housing member. A plurality of penetrating members are positioned in the disposable housing member. Each penetrating member is coupled to the drive force generator. A plurality of analyte detecting members are each associated with a penetrating member and are positioned in the disposable housing member. Each analyte detecting member is positioned in a sample chamber. The sample changers have openings for transport of a body fluid into the sample chamber. Each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Claims

1. A tissue penetrating system, comprising:

a penetrating member driver;

a disposable with a distal port and a proximal port and coupled to the penetrating member driver;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μ

L of the body fluid disposed in the sample chamber;

a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the disposable, wherein the sharpened distal tip of the penetrating member is configured to extend through an opening of the sample chamber;

a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting; and

a processor configured to monitor position and speed of the penetrating member and to control the penetrating member driver to adjust an application of force to the penetrating member.

2. The system of claim 1, wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into a target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, and a target tissue relaxation parameter.

3. The system of claim 1, wherein the user interface provides at least one output to the user selected from, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue, stratum corneum thickness, force delivered on a target tissue, energy used by the penetrating member driver to drive the penetrating member into a target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member, information relative to contact of the penetrating member with target tissue before penetration by the penetrating member, and information relative to a change of speed of the penetrating member as it travels in the target tissue.

4. The system of claim 1, further comprising:

a data interface configured to couple the tissue penetrating system to at least one of, support equipment with a data interface and the internet.

5. The system of claim 4, wherein support equipment is selected from at least one of, a base station, home computer, central server, and main processing equipment for storing glucose level information.

6. The system of claim 4, wherein a data interface is selected from at least one of, Serial RS-232, modem interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, BLUETOOTH interface, cellular telephone interface, 2 way pager interface, parallel port interface standard, near field magnetic coupling, RF transceiver and a telephone systems.

7. The system of claim 1, wherein the user interface includes a real time clock and one or more alarms to provide a user with a reminder of when a next target penetrating event is needed.

8. The system of claim 1, wherein the processor is configured to receive signals from the user interface and to assist in the adjustment of force applied to the penetrating member driver in response to the signals.

9. The system of claim 1, further comprising:

a user interface processor coupled to the user interface.

10. The system of claim 1, further comprising:

a memory for storing a target tissue parameter.

11. The system of claim 1, further comprising:

a memory for storing data on target tissue penetrating performance.

12. The system of claim 1, further comprising:

a memory for storing at least one of, a number of penetrating members used, number of target tissue penetrating events, time and date of a last selected number of target tissue penetrating events, time interval between alarm and target tissue penetrating event, stratum corneum thickness, time of day, energy consumed by the penetrating member driver to drive a penetrating member into a target tissue, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, a target tissue relaxation parameter, force delivered on the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue, a tissue target tissue relaxation parameter, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue, information relative to consumed sensors and information relative to consumed penetrating members.

13. The system of claim 1, the user interface responds to audio commands.

14. The system of claim 13, wherein the user interface includes a sensor for detecting audio commands.

15. The system of claim 1, wherein the user interface relays information to a user via an audio device.

16. The system of claim 1, wherein the user interface relays information to a user via a wireless device.

17. A tissue penetrating system, comprising:

a penetrating member driver;

a disposable with a distal port and a proximal port and coupled to the penetrating member driver;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μ

L of the body fluid disposed in the sample chamber;

a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the disposable, wherein the sharpened distal tip of the penetrating member is configured to extend through an opening of the sample chamber; and

a human interface providing at least one output.

18. The system of claim 17, further comprising:

a processor coupled to a penetrating member driver and configured to change a direction and magnitude of force exerted on a penetrating member as it penetrates or advances through a target tissue.

19. The system of claim 17, further comprising:

a penetrating member sensor configured to detect a penetrating member position during target tissue penetration.

20. The system of claim 17, wherein the at least one output is selected from, a penetration event of a penetrating member, number of penetrating members remaining, time of day, alarm, penetrating member trajectory waveform profile information, force for a last penetration event, high or low battery status, analyte status, time to change cassette status, jamming malfunction, and system status.

21. The system of claim 17, wherein the human interface is selected from an LED, an LED digital display, an LCD display, a sound generator, a buzzer, and a vibrating device.

22. The system of claim 17, wherein a housing is selected from at least one of, a telephone, a watch, a PDA, electronic device, medical device, point of care device and a decentralized diagnostic device.

23. The system of claim 17, further comprising:

an input device coupled to the housing, the input device selected from one or more pushbuttons, a touch pad independent of a display device, or a touch sensitive screen on a visual display.

24. The system of claim 17, further comprising:

a data exchange device for coupling the tissue penetrating system to support equipment.

25. The system of claim 24, further comprising:

a data interface configured to couple the tissue penetrating system to support equipment with a data interface.

26. The system of claim 17, further comprising:

a data exchange device for coupling the tissue penetrating system to support equipment selected from one of the following;

personal computer, modem, PDA and a computer network.

27. The system of claim 17, wherein the human interface includes a real time clock and one or more alarms a user can set for reminders of when a next target tissue penetration event is needed.

28. The system of claim 17, wherein the human interface is coupled to receive signals from a human interface processor separate from a processor coupled to the penetrating member driver.

29. The system of claim 28, wherein the human interface processor has a sleep mode and runs intermittently to conserve power.

30. The system of claim 17, further comprising:

a memory for storing at least one of, a number of penetrating members used, number of target tissue penetrating events, time and date of a last selected number of target tissue penetrating events, time interval between alarm and target tissue penetrating event, stratum corneum thickness, time of day, energy consumed by the penetrating member driver to drive a penetrating member into a target tissue, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, a target tissue relaxation parameter, force delivered on the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue, a tissue target tissue relaxation parameter, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue, information relative to consumed sensors and information relative to consumed penetrating members.

31. The system of claim 28, wherein the human interface processor has logic that provides an alarm time set for a first subset of days and a second alarm time set for a second subset of days.

32. The system of claim 31, wherein the first subset of days is Monday through Friday and the second subset of days is Saturday and Sunday.