BODY FLUID SAMPLING DEVICE - SAMPLING SITE INTERFACE

• US 20180214059A1
• Filed: 11/29/2017
• Published: 08/02/2018
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: ESCUTIA, Raul, LITHERLAND, Craig M., EMERY, Jeffrey L., JONES, Jeffrey M., TOMASCO, Michael F., LIPMAN, Kelley J.
• Granted Patent: US 11,045,125 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150091 by electricity
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15151 : Each piercing element being stocked in a separate isolated 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/422 : Desensitising skin

Abstract

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Claims

1-48. -48. (canceled)

49. An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site, the system comprising:

a housing comprising a first opening;

a first skin interface member disposed in the first opening and removably attached thereto, the first skin interface member comprising a second opening;

a second skin interface member configured to be disposed in the first opening and removably attached thereto; and

at least one skin-penetration member comprising a penetrating end aligned with the second opening;

wherein the first skin interface member is exchangeable with the second skin interface member, the first skin interface member configured to provide a first penetration depth of the skin-penetration member into the skin surface, and the second skin interface member configured to provide a second penetration depth of the skin-penetration member into the skin surface.

50. The arrangement of claim 49, wherein the first skin interface member differs in at least one dimension compared to the second skin interface member.

51. The arrangement of claim 50, wherein the first skin interface member has a first thickness and the second skin interface member has a second thickness different from the first thickness.

52. The arrangement of claim 49, wherein the second opening has a variable diameter.

53. The arrangement of claim 49, wherein the first skin interface member comprises an inner member comprising the second opening and an outer member at least partially surrounding the inner member, wherein a perimeter portion of the outer member is affixed to the housing.

54. The arrangement of claim 53, wherein the inner member and the outer member are integral.

55. The arrangement of claim 53, wherein the outer member is configured to flex more than the inner member upon application of force to the first skin interface member.

56. The arrangement of claim 49, further comprising a cartridge disposed within the housing, wherein the at least one skin-penetration member is disposed within the cartridge.

57. The arrangement of claim 56, wherein the cartridge further comprises at least one analyte quantification member.

58. The arrangement of claim 57, wherein the analyte quantification member comprises an assay pad containing a chemical reagent.

59. The arrangement of claim 56, wherein the cartridge comprises an outer surface, and wherein the first skin interface member is constructed and arranged to form a seal with the outer surface of the cartridge upon being pressed against the skin of the user.

60. The arrangement of claim 56, further comprising a plurality of skin-penetration members and a plurality of analyte quantification members operatively arranged in the cartridge such that multiple tests can be performed using the arrangement without replacing the cartridge.

61. The arrangement of claim 49, further comprising at least one sensor capable of detecting when the first skin interface member contacts the skin surface of a user at the sampling site.

62. An arrangement for producing a sample of body fluid from a wound opening created in a skin surface of a user at a sampling site, the arrangement comprising:

a housing comprising a first opening;

a first skin interface member disposed in the first opening and removably attached thereto, the skin interface member comprising a second opening;

a second skin interface member configured to be disposed in the first opening and removably attached thereto; and

at least one skin-penetration member comprising a penetrating end aligned with the second opening,

wherein the first skin interface member is exchangeable with the second skin interface member, the first skin interface member configured to provide a first separation distance between the housing and the skin surface, and the second skin interface member configured to provide a second separation distance between the housing and the skin surface.

63. The arrangement of claim 62, wherein the first skin interface member differs in at least one dimension compared to the second skin interface member.

64. The arrangement of claim 63, wherein the first skin interface member has a first thickness and the second skin interface member has a second thickness different from the first thickness.

65. The arrangement of claim 62, wherein the second opening has a variable diameter.

66. The arrangement of claim 62, wherein the first skin interface member comprises an inner member comprising the second opening and an outer member at least partially surrounding the inner member, wherein a perimeter portion of the outer member is affixed to the housing.

67. The arrangement of claim 66, wherein the inner member and the outer member are integral.

68. The arrangement of claim 66, wherein the outer member is configured to flex more than the inner member upon application of force to the first skin interface member.

69. The arrangement of claim 62, further comprising a cartridge disposed within the housing, wherein the cartridge comprises a plurality of skin-penetration members and a plurality of analyte quantification members operatively arranged in the cartridge such that multiple tests can be performed using the arrangement without replacing the cartridge.

70. The arrangement of claim 69, wherein the cartridge comprises an outer surface, and wherein the first skin interface member is constructed and arranged to form a seal with the outer surface of the cartridge upon being pressed against the skin of the user.