Catheter With Microchannels For Monitoring The Concentration Of An Analyte In A Bodily Fluid

• US 20080214909A1
• Filed: 02/21/2006
• Published: 09/04/2008
• Est. Priority Date: 02/21/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Fuerst, Otto, List, Hans, Haar, Hans-Peter
• Application Number:
  US11/816,770
• Publication Number:
  US 20080214909A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6865 Access ports
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Catheter for monitoring the concentration of an analyte in a body fluid having an implantable distal area (7) for the uptake of body fluids and a proximal area (8) with an outlet opening (14), wherein the catheter comprises a catheter casing (1) having microopenings which are permeable to at least part of the body fluid and at least partially hold back corpuscular components, and a catheter core (2) which is located in the catheter casing (1). The catheter core preferably has a microstructure on its peripheral surface and/or the catheter casing has a microstructure on its inner wall which form a hollow space between the catheter core and catheter casing. Moreover the invention concerns a method for the manufacture of such a catheter.

Claims

1-31. -31. (canceled)

32. A catheter for monitoring the concentration of an analyte in a body fluid, the catheter including:

an outlet opening;

a catheter casing including at least one micro-opening sized to be permeable to at least part of the body fluid and to at least partially hold back corpuscular components of the body fluid; and

a catheter core at least partially located in the catheter casing.

33. The catheter according to claim 32 wherein the catheter core includes a surface and a microstructure formed on the surface, the microstructure defining a hollow space between the catheter core and catheter casing.

34. The catheter according to claim 33 wherein the microstructure includes micro-channels.

35. The catheter according to claim 33 wherein the microstructure includes a plurality of truncated cones.

36. The catheter according to claim 33 wherein the microstructure includes a plurality of truncated pyramids.

37. The catheter according to claim 33 wherein the microstructure includes a plurality of spherical calottes.

38. The catheter according to claim 33 wherein the catheter core includes a first microstructure and a second microstructure, the first microstructure located at an implantable distal area and the second microstructure located at a proximal area.

39. The catheter according to claim 38 wherein the first microstructure is shaped differently from the second microstructure.

40. The catheter according to claim 38 wherein the first microstructure covers substantially the implantable distal area in its entirety and the second microstructure covers a portion of the proximal area.

41. The catheter according to claim 32 wherein the catheter casing includes an inner wall and a microstructure formed on the inner wall.

42. The catheter according to claim 32 wherein a cross-section of the catheter casing is substantially round.

43. The catheter according to claim 32 wherein a cross-section of the catheter casing is substantially elliptical.

44. The catheter according to claim 32 wherein the catheter core lies coaxially within the catheter casing.

45. The catheter according to claim 32 wherein the catheter casing has a substantially rectangular profile and the catheter core has a complementary profile.

46. The catheter according to claim 33 wherein the microstructure includes axial grooves.

47. The catheter according to claim 33 wherein the microstructure of the catheter core includes transverse grooves.

48. The catheter according to claim 32 wherein the catheter core has a monolithic structure.

49. The catheter according to claim 34 wherein the micro-channels have a width between about 5 to about 20 μ

m.

50. The catheter according to claim 34 wherein the micro-channels have a depth between about 5 to about 20 μ

m.

51. The catheter according to claim 32 wherein the catheter casino includes a hollow area and the catheter core fills at least about 95% of the catheter casing.

52. The catheter according to claim 32 wherein the micro-openings have a diameter between about 0.01 μ

m to about 1 μ

m.

53. A system for monitoring the concentration of an analyte in a body fluid comprising:

a catheter having an implantable distal area and a proximal area including an outlet including;

a catheter casing with a plurality of micro-openings which are permeable to at least a part of the body fluid and at least partially impermeable to corpuscular components of the body fluid;

a catheter core at least in part located in the catheter casing; and

a detection area for detecting the analyte in the body fluid.

54. The system as set forth in claim 53 wherein the catheter core is located substantially coaxial with the catheter casing.

55. The system according to claim 53 wherein the peripheral surface of the catheter core has a microstructure defining a hollow space between the catheter core and catheter casing.

56. The system according to claim 55 wherein the microstructure includes micro-channels.

57. The system according to claim 53 wherein the catheter casing includes an inner wall and the inner wall includes a microstructure.

58. The system according to claim 53 further including a second detection area.

59. The system according to claim 58 wherein the detection areas are formed on a continuous test element.

60. The system according to claim 59 wherein the test element is a tape.

61. The system according to claim 53 further including means for generating a negative pressure in the catheter.

62. A method for producing a catheter for monitoring the concentration of an analyte in a body fluid including the steps of:

generating at least one micro-opening in a catheter casing, the at least one micro-opening being permeable to at least a part of the body fluid and at least partially impermeable to corpuscular components of the body fluid; and

assembling the catheter casing around a catheter core.

63. The method according to claim 62 further including the step of forming micro-channels in the catheter core by microform ablation with a laser.

64. The method according to claim 62 further including the step of forming micro-channels in the catheter core by electrochemically etching.

65. The method according to claim 62 further including the step of forming micro-channels in the catheter core by photolithographic material ablation.

66. A method for monitoring the concentration of an analyte in a body fluid including the steps of:

taking up body fluid in an implantable distal area of a catheter having a catheter casing with micro-openings permeable to at least a part of the body fluid and at least partially impermeable to corpuscular components;

transporting the body fluid from the distal area to a proximal area of the catheter;

contacting the body fluid with a detection area; and

detecting the analyte.

67. The method according to claim 66 further including the step of applying a negative pressure to transport the body fluid from the distal area to the proximal area of the catheter.

68. The method according to claim 66 wherein the body fluid in the catheter is transported at a delivery rate of about 10 nl/min and the body fluid is substantially conveyed in less than approximately 15 min from the distal area to the proximal area of the catheter.