Method and apparatus for penetrating tissue
View Patent ↗A tissue penetration device includes a penetrating member driver and a cartridge. A plurality of penetrating members are integrated with the cartridge. Each penetrating member is coupled to the penetrating member driver when advanced along a path into a tissue target. 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.
1. A tissue penetration device, comprising:
a penetrating member driver;
a cartridge;
a plurality of penetrating members integrated with the cartridge, each of penetrating member coupled to the penetrating member driver when advanced along a path into a tissue target; and
a penetrating member position sensor coupled to a processor, the processor including a memory that includes stored information of (i) a distance of a penetrating member tip from a target tissue, (ii) acceleration and displacement of the penetrating member; and (iii) a start position of the penetrating member, the processor using the stored information to calculate depth of penetration of the penetrating member and
a feedback loop coupled to the penetrating member position sensor.
2. The system of claim 1 , wherein the depth of penetration is 100 to 2500 microns.
3. The system of claim 1 , wherein the depth of penetration is 500 to 750 microns.
4. The system of claim 1 , wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.
5. The system of claim 1 , further comprising:
a second penetrating member sensor configured to provide an indication of velocity of a penetrating member.
6. The system of claim 1 , wherein the penetrating member driver is an electric drive force member.
7. The system of claim 1 , wherein the penetrating member driver is a voice coil drive force generator.
8. 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.
9. The system of claim 8 , 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.
10. The system of claim 9 , 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.
11. The system of claim 10 , 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.
12. The system of claim 10 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.
13. The system of claim 10 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.
14. The system of claim 10 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.
15. The system of claim 10 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.
16. The system of claim 10 , 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.
17. 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.
18. 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.
19. The system of claim 1 , further comprising:
a plurality of cartridges integrated in a cassette.
20. The system of claim 19 , wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.
21. The system of claim 1 , wherein the penetrating member sensor includes an optical encoder.
22. The system of claim 1 , further comprising:
an analyte detecting member.
23. The system of claim 1 , further comprising:
a plurality of analyte detecting members each coupled to a penetrating member.
24. 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.
25. The system of claim 24 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm 3 .
26. The system of claim 24 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm 3 .
27. The system of claim 24 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm 3 .
28. The system of claim 24 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm 3 .
29. The system of claim 24 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm 3 .
30. 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.
31. 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.
32. 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.
33. 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.
34. The system of claim 1 , further comprising:
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.
35. The system of claim 1 , further comprising:
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.
36. The system of claim 1 , further comprising:
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.
37. The system of claim 1 , further comprising:
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.
38. The system of claim 1 , further comprising:
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.
39. The system of claim 1 , wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm 3 /penetrating member.
40. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm 3 /penetrating member.
41. The system of claim 1 , wherein the each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm 3 /penetrating member.
42. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm 3 /penetrating member.
43. The system of claim 1 , where in each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm 3 /penetrating member.
44. The system of claim 1 , further comprising:
a first seal formed by a fracturable material between the penetrating member and the cartridge, the first seal being positioned at least one of a distal port or a proximal port of the cartridge
45. The system of claim 44 , further comprising
a second fracturable seal located at least one of the distal port or proximal port of cartridge.
46. The system of claim 1 , wherein each penetrating member is an elongate member without molded attachments.
47. The system of claim 1 , further comprising:
a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.
48. The system of claim 1 , further comprising,
a belt for holding the penetrating members in an array configuration.
49. The system of claim 1 , further comprising:
a tape device configured to hold the penetrating members in an array configuration.
50. The system of claim 1 , further comprising:
a support channel configured to hold the penetrating members in an array configuration.
51. The system of claim 1 , further comprising:
a cog configured to hold the penetrating members in an array configuration.
52. The system of claim 1 , further comprising:
a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.
53. The system of claim 1 , further comprising:
a support structure for receiving the penetrating members.