IP Library Granted Patent US 7,909,777
Granted Patent B2
US 7,909,777 · App. 11/536,729 · Granted Mar 22, 2011

Method and apparatus for penetrating tissue

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Quick Facts
Patent No.
US 7,909,777
App. No.
11/536,729
Granted
Mar 22, 2011
Kind
B2
Abstract

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims (57)

1. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member,

a plurality of sample chambers, each of a sample chamber associated with a penetrating member, each of a sample chamber including non-optical electrode analyte detecting members and having a volume no greater than 1 μL and, the sample chamber being positioned to receive fluid from a wound created by a penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and a volume of the sample chamber is less than 1 μL;

a penetrating member driver coupled to and for driving each of the plurality of penetrating members;

a penetrating member transport device for moving each of the plurality of penetrating members into a position for alignment with the penetrating member driver;

a processor configured to control the penetrating member driver and the penetrating member transport device to drive the plurality of penetrating members and determine that a penetrating member has contacted a skin surface, and in response the processor adjusting a speed of the penetrating member or the power delivered to the penetrating member for skin penetration to maintain a desired penetration velocity of the penetrating member, the processor determining whether a distal end of the penetrating member has reached a brake depth to achieve a desired final penetration depth of the penetrating member, wherein the processor uses a determination of skin contact by the penetrating member as a consideration of skin tenting by the penetrating member, wherein skin tenting is used as a consideration factor for brake depth, wherein the processor determines whether a distal end of the penetrating member has reached a brake depth based on an amount of said skin tenting, the brake depth being either pre-determined and programmed into the processor or the processor dynamically determines the brake depth during actuation and the processor causes a braking force to be applied to penetrating member and provide for a reduction in pain; and

a tissue stabilizing member coupled to the housing and configured to enhance spontaneous fluid flow from the target tissue to the sample chamber and provide a volume of fluid flow of about no more than 1 μL.

2. The system of claim 1 , wherein the tissue stabilizer member is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

3. The system of claim 1 , wherein the tissue stabilizer member creates a stretching of a skin surface.

4. The system of claim 1 , wherein the tissue stabilizer member includes a plurality of protrusions.

5. The system of claim 1 , wherein the tissue stabilizing device applies a stimulation to a target tissue.

6. The system of claim 1 , wherein in a 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.

7. The system of claim 6 , 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.

8. The system of claim 6 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

9. The system of claim 6 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

10. The system of claim 6 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

11. The system of claim 6 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

12. The system of claim 1 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

13. The system of claim 1 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

14. The system of claim 1 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

15. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member,

a plurality of sample chambers, each of a sample chamber associated with a penetrating member, each of a sample chamber including non-optical electrode analyte detecting members and having a volume no greater than 1 μL and, the sample chamber being positioned to receive fluid from a wound created by a penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and a volume of the sample chamber is less than 1 μL;

a penetrating member driver coupled to and for driving each of the plurality of penetrating members;

a penetrating member transport device for moving each of the plurality of penetrating members into a position for alignment with the penetrating member driver;

a processor coupled to a position sensor for controlling the penetrating member driver and the penetrating member transport device to drive the plurality of penetrating members and for determining that a penetrating member has contacted a skin surface, and in response the processor adjusts a speed of the penetrating member or the power delivered to the penetrating member for skin penetration to maintain a desired penetration velocity of the penetrating member, the processor determining whether a distal end of the penetrating member has reached a brake depth to achieve a desired final penetration depth of the penetrating member, wherein the processor uses a determination of skin contact by the penetrating member as a consideration of skin tenting by the penetrating member, wherein skin tenting is used as a consideration factor for brake depth, wherein the processor determines whether a distal end of the penetrating member has reached a brake depth based on an amount of said skin tenting, the brake depth being either pre-determined and programmed into the processor or the processor dynamically determines the brake depth during actuation and the processor causes a braking force to be applied to penetrating member and provide for a reduction in pain;

the final penetration depth being selected to provide that a sample volume of less than 1 μL is received in a sample chamber with a spontaneous flow of sample.

16. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member,

a plurality of non-optical analyte sensors;

a tissue stabilizing member coupled to the housing and configured to enhance spontaneous fluid flow from the target tissue to a sample chamber;

a penetrating member driver coupled to and for driving each of the plurality of penetrating members;

a penetrating member transport device for moving each of the plurality of penetrating members into a position for alignment with the penetrating member driver;

a processor coupled to a position sensor for controlling the penetrating member driver and the penetrating member transport device to drive the plurality of penetrating members and for determining that a penetrating member has contacted a skin surface, and in response the processor adjusts a speed of the penetrating member or the power delivered to the penetrating member for skin penetration to maintain a desired penetration velocity of the penetrating member, the processor determining whether a distal end of the penetrating member has reached a brake depth to achieve a desired final penetration depth of the penetrating member, wherein the processor uses a determination of skin contact by the penetrating member as a consideration of skin tenting by the penetrating member, wherein skin tenting is used as a consideration factor for brake depth, wherein the processor determines whether a distal end of the penetrating member has reached a brake depth based on an amount of said skin tenting, the brake depth being either pre-determined and programmed into the processor or the processor dynamically determines the brake depth during actuation and the processor causes a braking force to be applied to penetrating member and provide for a reduction in pain;

the final penetration depth being selected to provide that a sample volume of less than 1 μL is received in a sample chamber.

17. The system of claim 16 , wherein the tissue stabilizer member is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

18. The system of claim 16 , wherein the tissue stabilizer member creates a stretching of a skin surface.

19. The system of claim 16 , wherein the tissue stabilizer member includes a plurality of protrusions.

20. The system of claim 16 , wherein the tissue stabilizing device applies a stimulation to a target tissue.

21. The system of claim 16 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

22. The system of claim 16 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

23. The system of claim 16 , wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

24. The system of claim 16 , 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 within a desired range of speed.

25. The system of claim 16 , 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.

26. The system of claim 16 , wherein the processor is 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.

27. The system of claim 16 , wherein in a 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.

28. The system of claim 16 , 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.

29. The system of claim 16 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

30. The system of claim 16 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

31. The system of claim 16 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

32. The system of claim 16 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

33. The system of claim 16 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

34. The system of claim 16 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

35. The system of claim 16 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2012
From: PELIKAN TECHNOLOGIES, INC.
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 028229/0524 →
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 Nov 17, 2006
From: FREEMAN, DOMINIQUE M; BOECKER, DIRK; ALDEN, DON
To: PELIKAN TECHNOLOGIES, INC.
Reel/Frame 018532/0173 →