Medtronic Minimed, Inc.

Minimed, Inc.

Nannette M Van Antwerp

John Joseph Mastrototaro

William P Van Antwerp

Rajiv Shah

Udo Hoss

Bradley J Enegren

Edgardo C Halili

Kevin Branch

K Collin McIvor

James L Cabernoch

Michael E Miller

Rebecca K Gottlieb

Jenn-Hann Larry Wang

Bahar Reghabi

Yanan Zhang

James D Holker

Eunjoo Jin

Kent L Clark

Gopikrishnan Soundararajan

Guillermo A Calle

Garry M Steil

Barry P Pham

Gayane R Voskanyan

Ly Phou

Richard Lemos, Jr

Richard Lemos

Gayane Voskanyan

Embodiments of the invention provide a dual insertion set for supplying a fluid to a body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the first piercing member for supplying the fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the second piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to skin of the patient. Typically the first and second piercing members are arranged such that when the first and second piercing members are operatively coupled to the base, they are disposed in a spatial orientation designed to inhibit sensor interference that may be caused by compounds present in fluids infused through the cannula.

Combined sensor and infusion set using separated sites

The disclosure provides a sensor including a sensor having an external surface and a cannula. The cannula comprises a substantially cylindrical wall encircling a lumen, at least one aperture and a distal end. The sensor is positioned within the lumen and the distal end of the cannula extends beyond the sensor. This configuration functions for example to stabilize chemical reactions associated with the sensor by creating a buffer zone between the sensor and the surrounding tissues at the site of implantation. In certain embodiments, the sensor can further comprise an accessory material in proximity to the external surface, wherein the accessory material modifies the biological response of a tissue that is in contact with the sensor. The sensor can also comprise anchors that keeps the sensor in contact with subcutaneous tissue of a subject upon insertion of the sensor into the body of the subject.

Methods and materials for stabilizing analyte sensors

The methods and apparatus for detecting an analyte in blood are useful for detecting an analyte in tissue of a subject. The apparatus comprises a sensor, which comprises an elongated conductive material having a protrudent end, the protrudent end comprising an electrode that detects the presence of an analyte; a substrate affixed to the conductive material; and a support having an external surface, a proximal end, and a distal end. The conductive material is positioned on the support and the protrudent end of the conductive material protrudes beyond the distal end of the support. Optionally, the sensor is suspended within the lumen of a venous flow device. Typically, only a portion of the sensor is suspended within the lumen of the venous flow device, said portion comprising the protrudent end of the conductive material. Alternatively, the conductive material is positioned on the external surface of the intravenous infusion catheter.

Method for detecting an analyte in blood

The invention provides methods and apparatus for detecting an analyte in blood. The apparatus is particularly suited for bringing a sensor into direct contact with blood in vivo. The apparatus comprises a sensor that detects the presence of an analyte and an assembly means. The assembly means has a sensor end, wherein the sensor end of the assembly means is affixed to the sensor, and the assembly means is adapted for coupling with a venous flow device. By coupling with a venous flow device, the assembly means brings the sensor into direct contact with blood flowing through the venous flow device. Examples of venous flow devices that bring the sensor into direct contact with the blood of a subject include, but are not limited to, intravenous catheters and external blood loops, such as are used in extra corporeal membrane oxygenation or hemodialysis.

Blood contacting sensor

Protrudent analyte sensor

A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing material and a resealable insertion site coupled to one end of the site housing material. Preferably, the site housing material is formed to have an interior cavity with an opening. The site housing material is selected to promote tissue ingrowth and vascularization, and yet be free of tissue ingress. Also, the site housing material permits the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site provides a for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

Reusable analyte sensor site and method of using the same

A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing and a resealable insertion site coupled to one end of the site housing. Preferably, the site housing is formed to have an interior cavity, and includes an outer membrane made of a material selected to promote vascularization and having a first pore size, and an inner membrane made of a material selected to be free of tissue ingress. Also, the site housing permits the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site is provided for inserting the replaceable analyte sensor into the interior cavity of the site housing.

A sensor and method of making the same for implantation in a body that includes a substrate with notches cut in the substrate to form a necked down region in the substrate; and at least one sensor electrode formed from one or more conductive layers. Preferably, the thickness of the substrate ranges from approximately 25&#x3bc; to 350&#x3bc;, but the thickness of the substrate can range from 5&#x3bc; to 750&#x3bc;. The sensor may be incorporated in to a sensor assembly includes a slotted needle having a slot. The notches creating the necked down region allow the substrate to slide into the slotted needle, which that has the slot narrow enough to permit passage of the necked down region. However, a non-necked down region of the substrate is prevented from pulling out of the slotted needle through the slot. The slot of the slotted needle may also permit the necked down region of the substrate to slide down the slot.

Analyte sensor method of making the same

A glucose sensor package system that includes a glucose sensor and a protective package that indicates exposure to temperature changes to indicate proper temperature control. Also covered are methods of transporting and sterilizing the package. In addition, glucose sensors directed to various sizing and positioning of the electrodes on the glucose sensor are covered.

Glucose sensor package system

Glucose sensor

Growing community of inventors

Valencia, CA, United States of America

Nannette M Van Antwerp