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 Transcutaneous sensor insertion set

Details
Inventors: Lord, Peter C.; Van Antwerp, William P.; Mastrototaro, John J.; Cheney, II, Paul S.; Schnabel, Nannette M.;
Assignee: MiniMed Inc. (Sylmar, CA)
Primary Examiner: Cohen; Lee S.
Assistant Examiner: Greer; Bria M.
Attorney, Agent or Firm: Kelly Bauersfeld & Lowry

An insertion set is provided for transcutaneous placement of a sensor such as a glucose sensor at a selected site within the body of a patient. The insertion set comprises a slotted insertion needle extending through a mounting base adapted for mounting onto the patient's skin. A flexible thin film sensor includes a proximal segment carried by the mounting base and defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment protruding from the mounting base with sensor electrodes for transcutaneous placement. The proximal and distal segments of the sensor are linearly offset or misaligned, with the distal segment fitted within the insertion needle for transcutaneous sensor placement with the needle as the mounting base is pressed onto the patient's skin. The insertion needle can then be withdrawn to leave the sensor distal segment at the selected insertion position with the sensor electrodes in contact with patient blood or other extracellular fluid.

DETAILED DESCRIPTION In accordance with the invention, a subcutaneous insertion set is provided for placing a flexible sensor such as a thin film electrochemical sensor at a selected site within the body of a patient.
The insertion set comprises a slotted insertion needle extending through a mounting base adapted for seated mounting onto the patient's skin.
A flexible thin film sensor includes a proximal segment carried by the mounting base, and a distal segment protruding from the mounting base and having sensor electrodes thereon.
The proximal and distal segments of the sensor are linearly offset or misaligned so that the distal segment can be fitted into the slotted insertion needle for transcutaneous placement as the mounting base is pressed onto the patient's skin.
The insertion needle can be withdrawn from the mounting base, leaving the sensor distal segment at the selected position within the patient, such as a subcutaneous, intravascular, intramuscular, or intravenous site.
Conductive contacts on the sensor proximal end can be electrically connected to a suitable monitor device so that appropriate blood chemistry readings can be taken.
In the preferred form, the sensor proximal and distal segments are formed generally in parallel offset relation, with a short transition segment extending angularly therebetween.
The proximal segment is mounted on the mounting base in a position disposed generally parallel to the patient's skin, when the mounting base is seated upon the patient's skin.
The transition segment of the sensor is angularly folded for reception of the sensor distal segment to a position generally coaxially within the slotted insertion needle.
A retention member such as a bead of cured epoxy may be carried on the sensor distal segment to prevent lateral separation of the sensor from the insertion needle.
The distal segment of the flexible sensor is transcutaneously placed as the insertion needle pierces the patient's skin upon press-on placement of the mounting base onto the patient's skin



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