Body fluid collecting device

• US 20060116607A1
• Filed: 06/30/2003
• Published: 06/01/2006
• Est. Priority Date: 07/01/2002
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Nakamura, Toshihisa, Yaguchi, Yoshiaki
• Granted Patent: US 7,771,368 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150175 Adjustment of penetration depth
• 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 5/150503 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

Disclosed herein are a body fluid collecting device which is easy to operate to collect body fluid and which is capable of detecting specific components in body fluid with a small amount of sample, and a body fluid collecting device of the type integral with a sticking needle, which is simple in structure, is easy to assemble and permits easy control of sticking depth. The body fluid collecting device 1 has a needle accommodating part 2, a sensor 5, and a sensor holder 6. The needle accommodating section 2 has the sticking needle 4 including the needle body 41 and the hub 42, and the casing 3 to accommodate the sticking needle 4 such that it can move in the axial direction. The sensor 5 has the measuring part 51 at its distal end. The sensor 5 is held between the sensor holder 6 and the needle accommodating part 2. The sensor holder 6 is mounted on the distal end of the needle accommodating part 2. Such a part constitutes the second supporter 82. In the distal end of the sensor holder 6 is mounted the first supporter 81 which supports the vicinity of the measuring part 51. In addition, in the distal end of the sensor holder 6 is formed the blood duct 63 that introduces blood to the measuring part 51 after the blood has been squeezed out from the skin by sticking with the sticking needle 4.

Claims

1-27. -27. (canceled)

28. A body fluid collecting device including a sensor to detect a prescribed component in the body fluid, wherein

said sensor includes at its distal end a measuring part capable of holding said body fluid, and

said body fluid collecting device includes a first supporter to support the vicinity of said measuring part of said sensor and a second supporter to support said sensor at a place closer to the proximal end than said first supporter, and also includes means to prevent said body fluid from infiltrating into other parts than said measuring part.

29. The body fluid collecting device as defined in claim 28, wherein said first supporter is arranged closer to the central axis of said body fluid collecting device than said second supporter.

30. The body fluid collecting device as defined in claim 28, which further includes a body fluid duct which communicates with said first supporter and introduces said body fluid into said measuring part.

31. The body fluid collecting device as defined in claim 28, wherein said sensor electrically detects the prescribed component in the body fluid by contact with said body fluid.

32. A body fluid collecting device including a sensor to detect a prescribed component in the body fluid, wherein

said sensor includes at its distal end a measuring part capable of holding said body fluid, and

said body fluid collecting device includes a first supporter to support the vicinity of said measuring part of said sensor and a second supporter to support said sensor at a place closer to the proximal end than said first supporter, with said first and second supporters forming between them a non-contact space in which the surface of said sensor does not substantially come into contact with the inside of said body fluid collecting device.

33. The body fluid collecting device as defined in claim 32, wherein said first supporter has at its proximal end a concave that communicates with said non-contact space.

34. The body fluid collecting device as defined in claim 33, wherein said concave is a notch formed by cutting part of said first supporter.

35. The body fluid collecting device as defined in claim 32, wherein said sensor is bent or curved in said non-contact space.

36. The body fluid collecting device as defined in claim 32, wherein said first supporter is arranged closer to the central axis of said body fluid collecting device than said second supporter.

37. The body fluid collecting device as defined in claim 32, which further includes a body fluid duct which communicates with said first supporter and introduces said body fluid into said measuring part.

38. The body fluid collecting device as defined in claim 37, wherein said body fluid duct has a volume which is 0.5 to 2 times the volume of said measuring part.

39. The body fluid collecting device as defined in claim 37, wherein said body fluid duct is 0.1 to 10 mm in length and 0.1 to 3 mm in inside diameter.

40. The body fluid collecting device as defined in claim 37, wherein said measuring part is inclined with respect to the lengthwise direction of said body fluid duct and is positioned in the vicinity of the outlet opening of said body fluid duct.

41. The body fluid collecting device as defined in claim 37, which further includes a guide that projects from the distal end of said body fluid collecting device and introduces said body fluid into the inlet opening of said body fluid duct, said guide being formed such that the distance from the distal end thereof to the inlet opening of said body fluid duct is 1 to 10 mm.

42. The body fluid collecting device as defined in claim 32, wherein said sensor electrically detects the prescribed component in the body fluid by contact with said body fluid.

43. A body fluid collecting device of the type integral with a sticking needle, comprising:

a needle accommodating part provided with a sticking needle which sticks the skin to bleed body fluid,

a sensor to detect prescribed components in said body fluid, and

a sensor holder which is mounted on the distal end of said needle accommodating part, and which supports said sensor between said needle accommodating part and said sensor holder.

44. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor includes its distal end side curved or inclined toward the central axis of said sticking needle.

45. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor includes its proximal end side held between said needle accommodating part and said sensor holder.

46. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor is capable of holding said body fluid in its distal end and is provided with a measuring part to determine said prescribed components.

47. The body fluid collecting device of the type integral with a sticking needle as defined in claim 46, wherein said sensor holder includes a body fluid duct which introduces said body fluid into said measuring part.

48. The body fluid collecting device of the type integral with a sticking needle as defined in claim 47, wherein said measuring part is inclined with respect to the lengthwise direction of said body fluid duct and is positioned in the vicinity of the outlet opening of said body fluid duct.

49. The body fluid collecting device of the type integral with a sticking needle as defined in claim 47, wherein said sensor holder includes a guide that projects from the distal end thereof and introduces said body fluid into the inlet opening of said body fluid duct, so that said sticking needle sticks into the skin while the distal end of said guide is in contact with the skin.

50. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor holder is fixed by fitting to said needle accommodating part.

51. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, which further includes means to position said sensor holder with respect to the lengthwise direction of said needle accommodating part.

52. The body fluid collecting device of the type integral with a sticking needle as defined in claim 51, wherein said positioning means is a step that is formed on the outside midway in the lengthwise direction of said needle accommodating part such that the proximal end of said sensor holder comes into contact with it.

53. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor holder has at least the distal end thereof made substantially transparent.

54. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, which is assembled after said needle accommodating part has undergone sterilization in such a state that its opening is sealed with a membrane, said opening being formed at the distal end of said needle accommodating part such that said sticking needle can pass through it.

55. The body fluid collecting device of the type integral with a sticking needle as defined in claim 54, wherein said needle accommodating part keeps its inside sterilized until the time of use.

56. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, which assumes approximately a rectangular solid in its entire shape.

57. The body fluid collecting device of the type integral with a sticking needle as defined in claim 43, wherein said sensor electrically detects the prescribed component in the body fluid by contact with said body fluid.