Device and method for delivering or withdrawing a substance through the skin

• US 6,808,506 B2
• Filed: 02/04/2003
• Issued: 10/26/2004
• Est. Priority Date: 02/04/2002
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank E., Haider, M. Ishaq, Lastovich, Alexander G., Fentress, James K., Griggs, Julia, Sutter, Diane, Pettis, Ronald J.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/357,502
• Publication Number:
  US 20030220610A1
• Time in Patent Office: 630 Days
• Field of Search: 604/46, 604/47, 604/506, 606/186, 600/583, 424/449
• US Class Current: 604/47
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/3007 with specially designed jet passages at the injector's distal end
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. A device includes a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid. The dermal-access member extends at least 1 mm from the protrusion. A mechanism drives the device against the skin at a calculated speed of about 6 m/s to about 18 m/s.

Claims

1. An apparatus for delivering or withdrawing a fluid through at least one layer of the skin of a subject, the apparatus comprising:

a device comprising

a body having a top face, a bottom face spaced from the top face, and a side edge, the body defining at least one channel,

wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area, the bottom face further including at least one raised protrusion disposed on the second surface area, the at least one raised protrusion having a height from the first surface, and the height being greater than the first distance;

at least one dermal-access member provided in the at least one raised protrusion and being in fluid communication with the channel to deliver or withdraw the fluid, the at least one dermal-access member extending at least 1 mm from the at least one protrusion; and

means for driving the device against the skin at a calculated speed of about 6 m/s to about 18 m/s.

2. The apparatus of claim 1, wherein the at least one raised protrusion is a conical protrusion with a flattened upper surface having a diameter of less than 2 mm.

3. The apparatus of claim 2, wherein the flattened upper surface has a diameter of about 1 mm.

4. The apparatus of claim 1, wherein the at least one dermal-access member extends about 3 mm from the at least one protrusion.

5. The apparatus of claim 1, wherein the driving means drives the device against the skin at a calculated speed of about 12 m/s.

6. The apparatus of claim 1, wherein the second distance is at least about 0.5 mm greater than the first distance.

7. The apparatus of claim 1, wherein the second distance is at least about 1 mm greater than the first distance.

8. The apparatus of claim 1, wherein said driving means includes a coil spring.

9. The apparatus of claim 1, wherein the device includes a plurality of protrusions and one dermal-access member is provided in each protrusion, and

wherein the dermal-access member of a respective protrusion is of a different length from the dermal-access member of another protrusion, the lengths of the dermal-access members being of sufficient lengths to deliver or withdraw the fluid from a subcutaneous layer of the skin and an intradermal layer of the skin.