IP Library Granted Patent US 7,648,468
Granted Patent B2
US 7,648,468 · App. 10/335,252 · Granted Jan 19, 2010

Method and apparatus for penetrating tissue

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Quick Facts
Patent No.
US 7,648,468
App. No.
10/335,252
Granted
Jan 19, 2010
Kind
B2
Abstract

A body fluid sampling system for use on a tissue site includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

Claims (60)

1. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered drive force generator and to a processor, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation; 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 that does not exceed a volume of 1 μL of a body fluid disposed in the sample chamber;

a penetrating member sensor coupled to said electrically powered force generator and provide depth penetration control of a penetrating member from a known start position, the penetrating member sensor being coupled to a processor with a memory that stores profiles which execute control instructions for the penetrating member driver, for application of a launching force to the penetrating member and control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue, the processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and through a transducer measure location of the penetrating member with the penetrating member sensor; and

wherein in the first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from the target tissue.

2. The system of claim 1 , wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

3. The system of claim 1 , wherein the driver is a voice coil drive force generator.

4. The system of claim 1 , wherein the driver is a rotary voice coil drive force generator.

5. The system of claim 1 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

6. The system of claim 5 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

7. The system of claim 5 , wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

8. The system of claim 5 , wherein the processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.

9. The system of claim 5 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

10. The system of claim 1 , wherein the penetrating member sensor includes an incremental encoder.

11. The system of claim 1 , wherein the penetrating member sensor includes an interference encoder.

12. The system of claim 1 further comprising an analyte detecting member.

13. The system of claim 1 further comprising a plurality of analyte detecting members positioned to receive body fluid.

14. The system of claim 1 , further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 1.0 μL of the body fluid.

15. The system of claim 1 , further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μL of the body fluid.

16. The system of claim 1 , further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μL of the body fluid.

17. The system of claim 1 , further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μL of the body fluid.

18. The system of claim 1 , further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μL of the body fluid.

19. The system of claim 1 wherein said seals are formed by a fracturable material between the penetrating member and the cartridge, at least one of said seals being positioned at least one of a distal port or a proximal port of the cartridge.

20. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered drive force generator, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation; and

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 that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber;

a processor with control instructions for the penetrating member driver, and provide depth penetration control of a penetrating member from a known start position, the processor being coupled to an amplifier to modulate rower from a power supply to the electrically powered drive force generator to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

21. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered drive force generator and to a processor, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

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 that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber;

a processor with control instructions for the penetrating member driver and provide depth penetration control of a penetrating member from a known start position, the processor being coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

22. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered drive force generator and to a processor, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

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 that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber;

a processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and having control instructions for the penetrating member driver, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

23. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered force generator, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

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 that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber;

a processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and having control instructions for the penetrating member driver, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

24. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a penetrating member operatively coupled to said electrically powered drive force generator and to a processor, said electrically powered drive force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

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 that does not exceed a volume of 1 μL of a body fluid disposed in the sample chamber:

a penetrating member sensor coupled to said electrically powered force generator and provide depth penetration control of a penetrating member from a known start position, the penetrating member sensor being coupled to a processor with control instructions for the penetrating member driver, for application of a launching force to the penetrating member and control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue; and

wherein in the first direction the penetrating member moves toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from the target tissue, the processor being coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and through a transducer measure location of the penetrating member with the penetrating member sensor.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2012
From: PELIKAN TECHNOLOGIES, INC.
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 028259/0051 →
RELEASE OF SECURITY INTEREST Recorded Mar 2, 2010
From: GENERAL ELECTRIC CAPITAL CORPORATION
To: PELIKAN TECHNOLOGIES, INC.
Reel/Frame 024016/0492 →
SECURITY AGREEMENT Recorded Dec 18, 2008
From: PELIKAN TECHNOLOGIES, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 021998/0381 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2003
From: FREEMAN, DOMINIQUE M.; BOECKER, DIRK; ALDEN, DON
To: PELIKAN TECHNOLOGIES INC.
Reel/Frame 013576/0521 →