Body fluid sampling/fluid delivery device

• US 20110306853A1
• Filed: 03/21/2011
• Published: 12/15/2011
• Est. Priority Date: 03/19/2010
• Status: Abandoned Application

• Current Assignee: Nanostar Health Corporation
• Original Assignee: Nanostar Health Corporation
• Inventors: Black, Michael Darryl, Chambers, Anita Margarette, Okulan, Nihat, Chambers, Richard
• Application Number:
  US13/052,887
• Publication Number:
  US 20110306853A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 2010/0077 Cerebrospinal fluid
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 5/30 : Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

A body fluid sampling or fluid delivery system includes a polymeric support and an array of polymeric microneedles coupled to the support, each of a microneedle having a height of 500 to 2000 μm and a tapering angle of 60 to 90°. A plurality of polymeric microchannels are provided with being associated with a microneedle. The plurality of polymeric microchannels are integrally formed with the array of polymeric microneedles without bonding. At least one polymeric reservoir is coupled to the plurality of microchannels.

Claims

1. A body fluid sampling or fluid delivery system, wherein the microchannels are capillary channels, comprising:

a polymeric support;

an array of polymeric microneedles coupled to the support, each of a microneedle, each of a microneedle having a height of 500 to 2000 μ

m and a tapering angle of 60 to 90°

;

a plurality of polymeric microchannels each of a microchannel being associated with a microneedle, the plurality of polymeric microchannels being integrally formed with the array of polymeric microneedles without bonding; and

at least one polymeric reservoir coupled to the plurality of microchannels.

2. The system of claim 1, wherein the polymeric support is coupled to the array of polymeric microneedles without bonding.

3. The system of claim 1, wherein the plurality of polymeric microchannels and the array of microneedles are integrally formed to provide for controlled dimensions and alignment of the microchannels with the microneedles.

4. The system of claim 1, wherein the support, microneedles, microchannels and the reservoir are formed of the same polymer.

5. The system of claim 1, wherein analysis of a body fluid substance is in at least one of the microchannels and the reservoir.

6. The system of claim 1, wherein analysis of a body fluid stance is in the microchannels.

7. The system of claim 1, wherein a first reservoir is provided for incoming fluids, and a second reservoir is providing for outgoing fluids.

8. The system of claim 1, wherein the array of microchannels are capillary channels.

9. The system of claim 8, wherein the size of the reservoir is no greater than 1 uL.

10. The system of claim 8, wherein each of a microneedle has a distal end diameter of 50 to 100 μ

L.

11. The system of claim 8, wherein each of a microneedle has a size and geometry to provide for a fluid exit velocity of at least 100 m/second.

12. The system of claim 1, wherein number of microneedles coupled to the support is about 9 to 250.

13. The system of claim 1, wherein the microneedles are microjets.

14. The system of claim 1, wherein the polymer is SU-8.

15. The system of claim 1, wherein at least a portion of the microneedles can have an off-centered through hole for fluid transport.

16. The system of claim 1, wherein the microneedles have controlled taper to provide for improved tissue penetration with reduced limited material hardness.

17. The system of claim 1, wherein the microneedles include a deposited coating at an exterior surfaces for improved modulus and hardness.

18. The system of claim 17, wherein the deposited coating is selected from at least one of, a metal and a dielectric.

19. The system of claim 17, wherein the deposited coating has a thickness of 1-10 μ

m.

20. The system of claim 1, wherein each microneedle is tapered.

21. The system of claim 20, wherein each microneedle has a taper created by at least one of, (i) overexposure, (ii) near-field diffraction, (iii) mask distance adjustment and (iv) using external filters to change the incident angle of the UV.

22. The system of claim 1, wherein each microneedle is tapered and has a flexible structural topologies.

23. The system of claim 1, wherein the array of microneedles is formed on a wafer level.

24. The system of claim 1, wherein each microneedle is a hollow needle with a lumen sized to be small enough to draw only interstitial fluid and large enough to draw whole blood.

25. The system of claim 1, wherein each microneedle is not hollow and is dimensioned at a narrowest point of a tip to be 1 nm-300 um.

26. The system of claim 1, wherein each microneedle has a length of 2 um-2.0 cm.

27. The system of claim 1, wherein an outer diameter at a base opposite from a injection distal end of each microneedle is 20-gauge (1 mm) to 2 um.

28. The system of claim 1, wherein each microneedle has a lumen with a size of 1 um to 1 mm.

29. The system of claim 1, wherein each microchannels is 1 um to 3 mm

30. The system of claim 1, wherein each microneedle has an injector nozzle of 0.9 mm to 1 um.

31. The system of claim 30, wherein each injector nozzle injects 2 um to 2 cms.

32. The system of claim 1, wherein each microneedle has a geometry selected from at least one of, cylindrical, semi-cylindrical, conical, flat-sided, step pyramidal, a combination of different distal tip geometries, straight, diagonal and angled.

33. The system of claim 1, wherein the array of microneedles has geometric configurations to provide for spontaneous flow of a fluid through or past a distal end of the microneedles.

34. The system of claim 1, wherein each microneedle has a lumen that is offset for a longitudinal axis of the microneedle and not in a center of a distal end of the microneedle.

35. The system of claim 1, wherein capillary action is used to provide for body fluid flow through each microneedle.

36. The system of claim 1, wherein each microneedle includes a protective cap at a distal end of the microneedle.

37. The system of claim 1, further comprising:

a seal that is not in contact with distal ends of the array of microneedles.

38. The system of claim 1, further comprising:

a diaphragm to protect a sample of body fluid from ambient air.

39. The system of claim 1, wherein a distance between adjacent microneedles is 2 um to 2 cm.

40. The system of claim 1, wherein the array of microneedles has a total area (height×

width) of 1 um to 4000 cm.

41. The system of claim 40, wherein the array of microneedles is a 24″

×

24″

array.

42. The system of claim 1, wherein each microneedle has a surface coating that interfaces with body tissue selected from at least one of, antimicrobial, anticoagulant, anti-stick agents, agents that have therapeutic effects on one or more body systems, diagnostic agents that include i.e. chemical substances used to reveal, pinpoint, and define localization of a pathological process, and genomic diagnostics.

43. The system of claim 42, wherein the surface coating extends from a distal end of each of a microneedle to about 2 um to 2 cm.

44. The system of claim 42, wherein the surface coating has a thickness of 1 angstrom to 10 um.

45. The system of claim 1, wherein the microneedles are configured to provide for body fluid withdrawal and injection of a fluid.

46. The system of claim 1, wherein the microneedles are sized for their distal ends of each microneedle to breach the skin, owning for skin surface tenting effects, and travel to a capillary bed but not extend to distal portions of nerve endings.

47. The system of claim 1, wherein controls are provided to control the introduction of the microneedles.

48. The system of claim 47, wherein the controls are selected from at least one of, velocity control, depth of penetration and braking.

49. The system of claim 1, wherein a depth of penetration of the microneedles through the skin and into a tissue site is 2 um to 2 cm.

50. The system of claim 1, wherein the array of microneedles has sufficient rigidity to be stiff enough to penetrate skin to a selected tissue site and sufficiently flexible to make a bend of a selected angle.

51. The system of claim 1, further comprising:

a device to assist in reducing an amount of pressure needed for skin penetration by the array of microneedles.

52. The system of claim 51, wherein the device to assist is selected from at least one of, vibration devices, electrical currents, and static or dynamic penetration.

53. The system of claim 1, wherein the capillary channels are coated or impregnated with different materials.

54. The system of claim 1, wherein the capillary channels are coated or impregnated with at least one a purified antibody selected from, CD3, CD4, CD4, CD7, CD8, CD15, CD19, CD20, CD34, CD45, CD57, Cytokeratin, HLA-DR, TCR (alpha beta), TCR (gamma delta), Bci-2, CD 16, CD1a, CD2, CD3 and CD4.

55. The system of claim 1, further comprising:

an electronic driver coupled to the array of microneedles.

56. A method of body fluid sampling from a patient, comprising:

providing a system with an array of microneedles and microchannels that are integrally formed;

introducing the array of microneedles into a patient;

collecting a body fluid from the patient in the sample chamber; and

measuring a parameter of the body fluid in the sample chamber.

57. The method of claim 56, wherein the parameter measured is used for blood typing.

58. The method of claim 56, wherein the parameter measured is used for performing diagnostic analysis (included but not limited to pharmacological testing, hematological analysis, body fluid analysis including but not limited to lymphatic fluid, interstitial fluid, urine, cerebrospinal fluid, intraocular fluids, biliary and ductal fluids, intra-cellular fluids;

therapeutic treatments, delivery of pharmaceuticals, vaccinations, vitamins, minerals and therapeutic supplements;

genomic diagnostics and gene removal;

analysis of genetic diseases and disorders, stem cell removal, and genetic material removal, and the like;

genetic therapies, delivery of stem cells, delivery of genetic materials into intraocular fluid and delivery of genetic materials into intracellular spaces.

59. The method of claim 56, wherein the collection occurs with a heel prick of the patient that can include a pinprick puncture made in a heel of a patient'"'"'s foot.

60. The method of claim 56, wherein the parameter measured is used for O₂ analysis.

61. The method of claim 56, wherein no more than a volume of blood is collected of 0.01-1.0 milliliter.

62. The method of claim 56, wherein the patient is a neonate.

63. The method of claim 57, wherein the neonate is a low birth weight low birth weight of <

1,500 gm, a very low birth weight of <

1,000 gm and an extremely low birth weight of <

500.

64. The method of claim 62, wherein blood gas concentration analysis of the neonate is performed at least every 6 hours on the neonate.

65. The method of claim 63, wherein the parameter measured is used to treat AOP.

66. The method of claim 56, wherein body fluids includes at least one of, blood from veins, venules, arteries, arterioles, capillaries, lymphatics, and interstitial fluid.

67. The method of claim 56 wherein body fluids include at least one of, urine, cerebrospinal fluid, intraocular fluids, biliary and ductal fluids.

68. The method of claim 56, wherein the microneedles are sufficiently small to provide for intra-cellular measurement.

69. The method of claim 56, wherein the parameter measured is used to at least treat a disease or condition that is, naturally occurring and caused by external means including but not limited to, radiation, bio-terrorism, oncological pollutants and poisons.