Medical skin mountable device and system

• US 8,747,363 B2
• Filed: 09/25/2012
• Issued: 06/10/2014
• Est. Priority Date: 04/13/2005
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Nielsen, Ole Christian, Radmer, Jim, Preuthun, Jan Harald, Teisen-Simony, Claude, Rorvig, Simon, Hansen, Steffen, Larsen, Bjorn Gullak, Moller, Claus Schmidt, Sparholt, Philip Albert, Ethelfeld, Erik Winkel, Bengtsson, Henrik
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/626,273
• Publication Number:
  US 20130172695A1
• Time in Patent Office: 623 Days
• Field of Search: 600/309, 600/316, 600/345, 600/347, 600/354, 604/174, 604/180
• US Class Current: 604/180
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A medical device is provided comprising a transcutaneous device unit and a process unit. The transcutaneous device unit may comprise a transcutaneous device for transporting a fluid through a skin portion of a subject, and a mounting surface adapted for application to the skin of the subject. The process unit may comprise a reservoir adapted to contain a fluid drug, the reservoir comprising an outlet means allowing the transcutaneous device to be arranged in fluid communication with an interior of the reservoir, and an expelling assembly for expelling a fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device. The transcutaneous device unit and the process unit further comprise coupling means allowing the reservoir unit to be secured to the transcutaneous device unit in the situation of use. By this arrangement a two-unit system is provided which can be used in a convenient and cost-effective manner.

Claims

1. A medical device, comprising a transcutaneous device unit and a process unit,

a) the transcutaneous device unit comprising:

a mounting surface adapted for application to the skin of a subject, and

a transcutaneous device comprising a distal end adapted to be inserted through the skin of a subject, the distal end being movable between an initial position in which the distal end is retracted relative to the mounting surface, and an extended position in which the distal end projects relative to the mounting surface,

b) the process unit comprising;

a process assembly adapted to cooperate with the transcutaneous device,

wherein;

the transcutaneous device unit and the process unit are adapted to be secured to each other to form a unitary device,

the transcutaneous device unit comprises a removable inserter portion, and

the inserter portion has to be removed prior to securing the process unit.

2. A medical device as in claim 1, wherein:

the transcutaneous device unit comprises a patch unit comprising the mounting surface, and

the removable inserter portion initially comprises the transcutaneous device, the inserter portion being adapted to be removed from the patch unit after the transcutaneous device has been inserted through the skin of the subject.

3. A medical device as in claim 1, wherein the transcutaneous device is provided in combination with a pointed insertion needle being retractable relative to the transcutaneous device.

4. A medical device as in claim 1, wherein the transcutaneous device unit comprises actuation means for moving the distal end of the transcutaneous device between the initial and the extended position when the actuation means is actuated.

5. A medical device as in claim 1, wherein the transcutaneous device is in the form of a transcutaneous sensor device, and the process assembly comprises a processor adapted to transmit and/or process data acquired via the sensor device.

6. A medical device as in claim 1, wherein the transcutaneous device is in the form of a transcutaneous access device, and the process assembly comprises a reservoir adapted to contain a fluid drug, an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the transcutaneous access device, and a processor for controlling the expelling assembly.

7. A medical device as in claim 1, wherein the process unit is adapted to be releasably coupled to the transcutaneous device unit thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin, and wherein at least partial removal of the process unit from the transcutaneous device unit at least partially uncovers the introduction site.

8. A medical device as in claim 1, the transcutaneous device unit comprising a housing portion to which the transcutaneous device is mounted when inserted, and a flexible sheet member provided with an adhesive layer on its lower surface, this allowing the transcutaneous device unit to be attached to the skin of the subject.

9. A system comprising:

a medical device as in claim 1, and

a remote control unit comprising a processor, the medical device and the remote control unit being adapted to transmit data there between.