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Transcutaneous sensor insertion set
| Details |
Inventors: Cheney, II, Paul S.; Mastrototaro, John J.; Schnabel, Nannette M.; Lord, Peter C.; Van Antwerp, William P.; Clark, Raymond D.;
Assignee: MiniMed Inc. (Sylmar, CA)
Primary Examiner: Sykes; Angela D.
Assistant Examiner: Gilbert; Samuel
Attorney, Agent or Firm: Kelly Bauersfeld & Lowry
An improved 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 an 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 adapted for electrical connection to a suitable monitor or the like, and a distal segment protruding from the mounting base with sensor electrodes thereon for transcutaneous placement. The distal segment of the sensor and a distal segment of the insertion needle are positioned within a flexible cannula which extends from the mounting base, whereby placement of the mounting base onto the patient's skin causes the insertion needle to pierce the skin for transcutaneous placement of the cannula with the sensor therein. The insertion needle can then be withdrawn from the cannula and the mounting base to leave the sensor distal segment at the selected insertion position, with the sensor electrodes being exposed to patient blood or other extracellular fluid via a window formed in the cannula. The cannula is carried by the mounting base to insure alignment of the sensor electrodes with the cannula window. |
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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 an 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 distal segment of the sensor and a distal segment of the insertion needle are carried within a hollow flexible cannula extending from the mounting base.
When the mounting base is pressed onto the patient's skin, the insertion needle pierces the skin for transcutaneous placement of the cannula with the sensor therein.
The insertion needle can then be withdrawn from the mounting base, leaving the sensor distal segment with the electrodes thereon exposed through a window or windows in the cannula for direct contact with patient fluid 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 and monitored.
In one aspect of the invention, the cannula includes structural means which cooperates with the mounting base and/or the sensor distal segment to insure alignment of the sensor electrodes with the cannula window.
More particularly, in the preferred form, a mounting flange at an upper end thereof, having a noncircular cross sectional shape such as a D-shaped cross section, for seated mounting within a matingly shaped recess formed in the mounting base.
With this construction, the cannula is rotationally oriented relative to the mounting base in a predetermined manner, such that the window or windows therein are also oriented in a predetermined manner for proper alignment with the sensor electrodes
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