MEDICAL AID

• US 20100056893A1
• Filed: 03/03/2009
• Published: 03/04/2010
• Est. Priority Date: 09/04/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Granted Patent: US 8,172,866 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids

Abstract

The invention relates to a medical aid which comprises a lancet (2) with a proximal end (5) and a distal end, the lancet (2) having a lancet body (4) and, at the proximal end (5), a lancet tip (3). The lancet (2) is at least partially enclosed by a packaging that comprises at least one flexible film section (7, 8) having a distal end (12), a proximal end (16), a first lateral edge and a second lateral edge. The lancet (2), at least partially enclosed by the packaging, is arranged displaceably between an upper protective section (9) and a lower protective section (10). The at least one flexible film section (7, 8) is detachably connected, along at least one segment of its first and second lateral edges, to an additional flexible film section (7, 8) or to one of the protective sections (9, 10). The at least one flexible film section (8) is connected to an additional flexible film section (7) or to one of the protective sections (9, 10) in the area of the lancet tip (3) via a detachable connection, such that the lancet tip (3) is enclosed by the packaging. The at least one flexible film section (7, 8) is further connected to one of the protective sections (9, 10) via a fixed connection at a distance from the detachable connection. The proximal ends (13, 16) of the lower and upper protective sections (10, 9) can be bent apart, as a result of which the distance between the detachable connection and the fixed connection can be increased and a tensile force can thus be applied to the detachable connection, such that the packaging is opened at the detachable connection and a proximal opening is created through which at least part of the lancet (2) can be pushed out from the packaging in the proximal direction (20).

Claims

1. A medical aid comprising a lancet with a proximal end and a distal end, the lancet having a lancet body and, at the proximal end, a lancet tip, and the lancet being at least partially enclosed by a packaging that comprises at least one flexible film section having a distal end, a proximal end, a first lateral edge and a second lateral edge, characterized in that the lancet, at least partially enclosed by the packaging, is arranged displaceably between an upper protective section and a lower protective section,

wherein the at least one flexible film section is detachably connected, along at least one segment of its first and second lateral edges, to an additional flexible film section or to one of the protective sections, and

wherein the at least one flexible film section is connected to an additional flexible film section or to one of the protective sections in the area of the lancet tip via a detachable connection, such that the lancet tip is enclosed by the packaging, and

wherein the at least one flexible film section is connected to one of the protective sections via a fixed connection at a distance from the detachable connection, and

wherein the proximal ends of the lower and upper protective sections can be bent apart, as a result of which the distance between the detachable connection and the fixed connection can be increased and a tensile force can thus be applied to the detachable connection, such that the packaging is opened at the detachable connection and a proximal opening is created through which at least part of the lancet can be pushed out from the packaging in the proximal direction.

2. The medical aid as claimed in claim 1, characterized in that the lancet is at least partially enclosed by a flexible packaging which comprises

an upper flexible film section having a distal end, a proximal end, a first lateral edge and a second lateral edge, and

a lower flexible film section having a distal end, a proximal end, a first lateral edge and a second lateral edge,

wherein the upper and lower flexible film sections are detachably connected to each other along at least one segment of their first and second lateral edges and at least partially enclose the lancet, wherein the lower flexible film section and the upper flexible film section are detachably connected to each other via a proximal seam in front of the lancet tip, and the lancet tip is thus enclosed by the flexible packaging, and wherein the proximal end of the lower flexible film section is fixedly connected to the lower protective section and the proximal end of the upper flexible film section is fixedly connected to the upper protective section, and the proximal ends of the lower and upper protective sections can be bent apart in order to open the flexible packaging at the proximal seam, whereupon at least part of the lancet can be pushed out from the flexible packaging and from the protective sections in the proximal direction.

3. The medical aid as claimed in claim 2, characterized in that the upper and lower flexible film sections are sections of a single flexible film that is bent back at the distal ends of the flexible film sections.

4. The medical aid as claimed in claim 1, characterized in that the lancet has a capillary structure formed by a half-open channel.

5. The medical aid as claimed in claim 1, comprising a driver element which engages through at least one of the protective sections, is connected to the lancet body and can be displaced together with the lancet in the proximal direction.

6. The medical aid as claimed in claim 5, characterized in that at least one of the protective sections has a recess through which the driver element slides and is guided during its displacement.

7. The medical aid as claimed in claim 1, characterized in that the distal end of the lancet body is adhesively bonded into the packaging.

8. The medical aid as claimed in claim 1, characterized in that the proximal end of one of the protective sections has, on its inside, a test area, which is provided for analysis of a sample.

9. The medical aid as claimed in claim 1, characterized in that the distal ends of the protective sections are connected to a holding element that comprises a spacer piece, by means of which the distal ends of the protective sections are held at a defined distance from each other.

10. A method for unpacking the medical aid as claimed in claim 1, characterized by

bending the proximal ends of the lower and upper protective sections apart, as a result of which the packaging is opened at the detachable connection, such that the proximal opening is created, and

pushing at least part of the lancet out from the packaging and from the protective sections in the proximal direction through the proximal opening, such that at least the lancet tip protrudes beyond the proximal ends of the protective sections.

11. The use of the medical aid as claimed in claim 1 for taking up a sample on a test area arranged on the inside at the proximal end of one of the protective sections, by means of the sample being taken up in a capillary structure formed by a half-open channel of the lancet and by means of the sample being scraped off onto the test area.

12. A sensor for detection of at least one analyte in a sample, in particular for detection of glucose in a blood sample or in interstitial fluid, comprising at least one test element with a proximal end and a distal end, the test element being at least partially enclosed by a packaging that comprises at least one flexible film section having a distal end, a proximal end, a first lateral edge and a second lateral edge,

characterized in that

the test element, at least partially enclosed by the packaging, is arranged displaceably between an upper protective section and a lower protective section,

wherein the at least one flexible film section is detachably connected, along at least one segment of its first and second lateral edges, to an additional flexible film section or to one of the protective sections, and

wherein the at least one flexible film section is connected to an additional flexible film section or to one of the protective sections in the area of the proximal end of the test element via a detachable connection, such that the proximal end of the test element is enclosed by the packaging, and

wherein the at least one flexible film section is connected to one of the protective sections via a fixed connection at a distance from the detachable connection, and

wherein the proximal ends of the lower and upper protective sections can be bent apart, as a result of which the distance between the detachable connection and the fixed connection can be increased and a tensile force can thus be applied to the detachable connection, such that the packaging is opened at the detachable connection and a proximal opening is created through which at least part of the test element can be pushed out from the packaging in the proximal direction.