Method and apparatus for penetrating tissue

• US 20120232425A1
• Filed: 05/21/2012
• Published: 09/13/2012
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Alden, Don
• Granted Patent: US 9,089,678 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Claims

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

a single drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator; and

a plurality of cartridges integrated in a disposable, wherein each of said cartridges houses one of said penetrating members; and

a penetrating member position sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface; and

wherein unused cartridges are stored in a linear stack.

2. The system of claim 1 further comprising:

a flexible support member coupling said cartridges together to define an array.

3. The system of claim 1, wherein the penetrating member is movable on each cartridge between a first position wherein the member is aligned essentially parallel to the plane of the cartridge and a second position wherein the member is aligned to be driven by the force generator to exit said cartridge towards the tissue.

4. The system of claim 1, wherein the penetrating member position sensor includes a capacitive incremental encoder.

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

6. The system of claim 1, wherein the penetrating member position sensor includes an optical encoder.

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

8. 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 μ

L of the body fluid.

9. 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 μ

L of the body fluid.

10. 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 μ

L of the body fluid.

11. 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 μ

L of the body fluid.

12. 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 μ

L of a body fluid disposed in the sample chamber.

13. 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 μ

L of a body fluid disposed in the sample chamber.

14. 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 μ

L of a body fluid disposed in the sample chamber.

15. 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 μ

L of a body fluid disposed in the sample chamber.

16. 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 μ

L of a body fluid disposed in the sample chamber.

17. 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 cm3/penetrating member.

18. 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 0.75 cm3/penetrating member.

19. 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 cm3/penetrating member.

20. 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 cm3/penetrating member.

21. 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 0.1 cm3/penetrating member.

22. The system of claim 21, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm3.

23. The system of claim 21, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm3.

24. The system of claim 21, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm3.

25. The system of claim 21, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm3.

26. The system of claim 21, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm3.

27. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

28. The system of claim 27, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

29. The system of claim 27, wherein the tissue stabilizer device creates a stretching of a skin surface.

30. The system of claim 27, wherein the tissue stabilizer device includes a plurality of protrusions.

31. The system of claim 27, wherein the tissue stabilizer device applies a vacuum to a target tissue.

32. The system of claim 27, wherein the tissue stabilizer device 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.

33. The system of claim 27, wherein the tissue stabilizing member applies a stimulation to a target tissue.

34. The system of claim 27, further comprising

a second fracturable seal located at least one of the distal port or proximal port of cartridge.

35. The system of claim 1, further comprising,

a belt for holding the penetrating members in an array configuration.

36. The system of claim 1, further comprising:

a tape device configured to hold the penetrating members in an array configuration.

37. The system of claim 1, further comprising:

a support channel configured to hold the penetrating members in an array configuration.

38. The system of claim 1, further comprising:

a cog configured to hold the penetrating members in an array configuration.

39. The system of claim 1, further comprising:

a vacuum source to provide a low pressure environment to draw fluid from a wound created by the penetrating member in the tissue.

40. The system of claim 1, further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

41. The system of claim 40, wherein the support structure is a bandolier.

42. The system of claim 40, wherein the support structure is a drum.

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

a drive force generator

a plurality of penetrating members operatively coupled to said force generator, said force generator controllably moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site for a selectable time period, and withdrawing out of said tissue site;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

said drive force generator configured to be controlled to follow a selectable velocity trajectory into the tissue and out of said tissue.

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

a drive force generator

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a position sensor configured to provide an indication of a position of the penetrating member during actuation.

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

a drive force generator

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

wherein said penetrating member is an elongate member without a molded attachment;

a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site.

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

an electrically powered drive force generator;

a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;

a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator;

a flexible support member coupling said cartridges to define a linear array, said support member being movable and configured to move each of said cartridges to said launch position associated with said force generator.

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

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation.

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

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation.

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

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit.

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

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μ

L of the fluid.

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

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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;

a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a spool in contact with at least one portion of the flexible support member, said spool configured to hold unused portions of the support member in a roll configuration.