Combined sensor and infusion set using separated sites

• US 9,968,742 B2
• Filed: 08/29/2007
• Issued: 05/15/2018
• Est. Priority Date: 08/29/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Van Antwerp, Nannette M., Shah, Rajiv, Enegren, Bradley J., Lemos, Jr., Richard, Phou, Ly, Steil, Garry M., Voskanyan, Gayane R.
• Primary Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/897,106
• Publication Number:
  US 20090062767A1
• Time in Patent Office: 3,912 Days
• Field of Search: 60416401, 60416407, 604264, 604272, 604 48, 604500, 604503, 604504, 604506, 604507, 604508, 604 65, 604 66, 604 67, 604 9301
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

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.

Claims

1. A method for inhibiting interference of an electrochemical glucose sensor that monitors glucose levels in a patient, wherein the interference is caused by a phenolic preservative present in an insulin infusate infused by an apparatus for supplying a fluid to a body of the patient, the method comprising supplying the fluid to the body of the patient using the apparatus comprising:

a base adapted to secure the apparatus to skin of the patient;

a first piercing member coupled to and extending from the base, wherein the first piercing member comprises at least one cannula for infusing the fluid to an infusion site,

a second piercing member coupled to and extending from the base and including the electrochemical sensor having a sensor electrode for determining the glucose levels of the patient at a sensor placement site,

infusion set tubing adapted to connect to the at least one cannula;

wherein;

the first and second piercing members are disposed on a hub that can operatively engage and disengage from the base;

the first and second piercing members are coupled to the base in an orientation such that when the first and second piercing members are inserted into the patient, a first perforation channel made by the first piercing member is not in operable contact with a second perforation channel made by the second piercing member such that the fluid infused to the infusion site cannot flow through the first perforation channel or the second perforation channel to the sensor; and

the first and second piercing members are coupled to the base in the orientation such that when the first and second piercing members are inserted into the patient, the sensor and the at least one cannula are separated by at least seven millimeters of tissue;

so that the interference is inhibited.

2. The method of claim 1, wherein the sensor comprises a plurality of layers including:

a glucose oxidase layer that detectably alters an electrical current at the electrode in a presence of glucose; and

an analyte modulating layer that modulates diffusion of glucose therethrough.

3. The method of claim 1, wherein the first and second piercing members are inserted into separate in vivo environments.

4. The method of claim 1, further comprising a medication infusion pump adapted to connect to the infusion set tubing.

5. A method for inhibiting interference of an electrochemical sensor that monitors a body characteristic of a patient, wherein the interference is caused by an interferant present in an infusate infused by an apparatus for supplying a fluid to a body of the patient, the method comprising supplying the fluid to the body of the patient using the apparatus comprising:

a base adapted to secure the apparatus to skin of the patient;

a first piercing member coupled to and extending from the base, wherein the first piercing member comprises at least one cannula for infusing the fluid to an infusion site,

a second piercing member coupled to and extending from the base and including the electrochemical sensor having a sensor electrode for determining the body characteristic of the patient at a sensor placement site,

infusion set tubing adapted to connect to the at least one cannula;

wherein;

the first and second piercing members are disposed on a hub that can operatively engage and disengage from the base;

the first and second piercing members are coupled to the base in an orientation such that when the first and second piercing members are inserted into the patient, a first perforation channel made by the first piercing member is not in operable contact with a second perforation channel made by the second piercing member such that the fluid infused to the infusion site cannot flow through the first perforation channel or the second perforation channel to the sensor;

the first and second piercing members are coupled to the base in the orientation such that when the first and second piercing members are inserted into the patient, the sensor and the at least one cannula are separated by at least seven millimeters of tissue; and

the first and second piercing members are coupled to the base in the orientation so that when the at least one cannula and the sensor are disposed in the patient, the at least one cannula and the sensor function to anchor the apparatus to the skin of the patient;

so that the interference is inhibited.