Medication fluid infusion set component with integrated physiological analyte sensor, and corresponding fluid infusion device

• US 10,709,834 B2
• Filed: 12/14/2017
• Issued: 07/14/2020
• Est. Priority Date: 12/21/2016
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chiu, Chia-Hung, Schultz, Peter, Voskanyan, Gayane R., Wang, Hsifu, Gottlieb, Rebecca K., Warnock, Kenneth D., Juarez Martinez, Ricardo
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US15/842,800
• Publication Number:
  US 20180169322A1
• Time in Patent Office: 943 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 2205/3303 Using a biosensor
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling

Abstract

Disclosed is a medical device component for delivering medication fluid to a patient. The medical device component includes a fluid infusion device to regulate delivery of medication fluid, a body-mountable base unit, and a top cover assembly that is removably couplable to the base unit and to the fluid infusion device. The base unit includes a cannula to deliver medication fluid under the control of the fluid infusion device, and a physiological analyte sensor to measure a physiological characteristic. The base unit also includes an electronics assembly electrically connected to sensor leads to obtain measurements in the analog domain, to convert measurements into digital sensor data, and to communicate conditioned digital sensor data to the fluid infusion device. The top cover assembly is configured to provide both fluid and electrical connections for the base unit, by way of an infusion tube having sensor conductors integrated therein or otherwise associated therewith.

Claims

1. A medical device component for delivering medication fluid to a patient, the medical device component comprising:

a body-mountable base unit comprising;

a base structure;

a lid assembly affixed and sealed to the base structure;

a body-insertable cannula that accommodates delivery of medication fluid to the patient, the cannula having an upstream end securely attached to the base structure and having a downstream end extending from the base structure;

a self-sealing septum coupled to the base structure to fluidly seal the upstream end of the cannula, wherein the self-sealing septum is maintained in position between the base structure and the lid assembly;

a body-insertable physiological analyte sensor secured to and extending from the base structure, the sensor facilitating measurement of a physiological characteristic of the patient, and the sensor comprising a plurality of sensor leads; and

an electronics assembly coupled to the base structure, the electronics assembly electrically connected to the sensor leads to obtain measurements of the physiological characteristic in an analog domain, and the electronics assembly comprising a digital processing circuit to convert measurements of the physiological characteristic from the analog domain into digital sensor data, to digitally process the digital sensor data into conditioned digital sensor data, and to communicate the conditioned digital sensor data to a fluid infusion device associated with the medical device component; and

a top cover assembly that is removably couplable to the body-mountable base unit such that the top cover assembly covers the lid assembly of the body-mountable base unit, the top cover assembly comprising;

a lid structure that releasably mates with the base structure, the lid structure comprising an interior space defined by an inner surface of the lid structure, and the lid structure comprising at least one structural support feature;

an infusion tube secured to the inner surface of the lid structure and terminating within the interior space, wherein the at least one structural support feature of the lid structure receives, secures, and retains a downstream end of the infusion tube;

a tubing connector fluidly coupled to the infusion tube, the tubing connector having a distal end supported by the at least one structural support feature of the lid structure, the distal end of the tubing connector penetrating the self-sealing septum to establish a fluid delivery flow path from inside the infusion tube, through the self-sealing septum, and into the cannula when the top cover assembly is coupled to the body-mountable base unit, wherein the self-sealing septum seals the upstream end of the cannula when the top cover assembly is removed from the body-mountable base unit and the tubing connector is withdrawn from the self-sealing septum;

a plurality of sensor conductors carried by or integrated with the infusion tube, the sensor conductors terminating within the interior space; and

an electrical interconnect assembly coupled to the inner surface of the lid structure, the electrical interconnect assembly establishing electrical connectivity between the sensor conductors and the electronics assembly when the top cover assembly is coupled to the body-mountable base unit, to facilitate communication of the conditioned digital sensor data from the electronics assembly to the fluid infusion device.

2. The medical device component of claim 1, the plurality of sensor leads comprising:

a reference conductor for a reference electrode of the sensor;

a working conductor for a working electrode of the sensor; and

a counter conductor for a counter electrode of the sensor.

3. The medical device component of claim 1, wherein:

the sensor conductors are embedded in tubing material of the infusion tube; and

terminating ends of the sensor conductors extend from an end of the infusion tube, and are exposed for connection to the electrical interconnect assembly.

4. The medical device component of claim 1, wherein:

the medical device component further comprises a connector assembly coupled to a second end of the infusion tube, the connector assembly being configured to fluidly couple the infusion tube to a fluid reservoir of the fluid infusion device, and to electrically couple the sensor conductors to an electronics module of the fluid infusion device.

5. The medical device component of claim 1, wherein:

the fluid infusion device is an insulin infusion pump;

the medical device component is an insulin infusion component;

the body-insertable physiological analyte sensor comprises a glucose sensor; and

the infusion tube is compatible with insulin medication fluid.

6. The medical device component of claim 1, the base unit further comprising a connector structure for the conditioned digital sensor data, the connector structure mating with electrical contact pads of the electrical interconnect assembly when the top cover assembly is coupled to the body-mountable base unit.

7. The medical device component of claim 6, wherein:

the connector structure comprises conductive elements corresponding to a power conductor, a ground conductor, and a data conductor for communication of the conditioned digital sensor data; and

the electrical contact pads of the electrical interconnect assembly physically contact the conductive elements of the connector structure when the top cover assembly is coupled to the body-mountable base unit.

8. The medical device component of claim 6, the connector structure comprising:

a pedestal extending from the body-mountable base unit; and

interconnection plugs positioned within the pedestal, the interconnection plugs formed from a conductive elastomeric material, wherein each of the interconnection plugs has a lower end electrically coupled to a corresponding conductive pad of the electronics assembly of the body-mountable base unit.

9. The medical device component of claim 6, further comprising a protective cap for the connector structure, the protective cap mating with and sealing the connector structure when the top cover assembly is removed from the body-mountable base unit.

10. The medical device component of claim 1, wherein the body-mountable base unit comprises:

a top surface;

a first hole formed in the top surface, the first hole accommodating the tubing connector, and the first hole accommodating a first insertion needle for inserting the cannula into skin of the patient; and

a second hole formed in the top surface, the second hole accommodating a second insertion needle for inserting the physiological analyte sensor into skin of the patient.

11. The medical device component of claim 1, wherein at least two of the sensor conductors carried by or integrated with the infusion tube provide operating power from the fluid infusion device to the electronics assembly when the top cover assembly is coupled to the body-mountable base unit.

12. The medical device component of claim 11, further comprising a battery that provides operating power to the electronics assembly when the top cover assembly is removed from the body-mountable base unit.

13. A medical device component for delivering medication fluid to a patient, the medical device component comprising:

a fluid infusion device to regulate delivery of medication fluid;

a base unit comprising;

a base structure;

a lid assembly affixed and sealed to the base structure;

a cannula that accommodates delivery of medication fluid as controlled by the fluid infusion device, the cannula having an upstream end securely attached to the base structure and having a downstream end extending from the base structure;

a self-sealing septum that fluidly seals the upstream end of the cannula, wherein the self-sealing septum is maintained in position between the base structure and the lid assembly;

a physiological analyte sensor that facilitates measurement of a physiological characteristic, the sensor comprising a plurality of sensor leads, the physiological analyte sensor secured to and extending from the base unit; and

an electronics assembly electrically connected to the sensor leads to obtain measurements of the physiological characteristic in an analog domain, and the electronics assembly comprising a digital processing circuit to convert measurements of the physiological characteristic from the analog domain into digital sensor data, to digitally process the digital sensor data into conditioned digital sensor data, and to communicate the conditioned digital sensor data to the fluid infusion device; and

a top cover assembly that is removably couplable to the base unit such that the top cover assembly covers the lid assembly of the base unit, the top cover assembly comprising;

a lid structure that releasably mates with the base unit, the lid structure comprising an interior space defined by an inner surface of the lid structure, and the lid structure comprising at least one structural support feature;

an infusion tube secured to the inner surface of the lid structure and terminating within the interior space, wherein the at least one structural support feature of the lid structure receives, secures, and retains a downstream end of the infusion tube;

a tubing connector fluidly coupled to the infusion tube, the tubing connector having a distal end supported by the at least one structural support feature of the lid structure, the distal end of the tubing connector penetrating the self-sealing septum to establish a fluid delivery flow path from inside the infusion tube, through the self-sealing septum, and into the cannula when the top cover assembly is coupled to the base unit, wherein the self-sealing septum seals the upstream end of the cannula when the top cover assembly is removed from the base unit and the tubing connector is withdrawn from the self-sealing septum;

a plurality of sensor conductors terminating within the interior space; and

an electrical interconnect assembly coupled to the inner surface of the lid structure, the electrical interconnect assembly establishing electrical connectivity between the sensor conductors and the electronics assembly when the top cover assembly is coupled to the base unit, to facilitate communication of the conditioned digital sensor data from the electronics assembly to the fluid infusion device.

14. The medical device component of claim 13, wherein:

the sensor conductors are carried by or integrated with the infusion tube; and

terminating ends of the sensor conductors extend from an end of the infusion tube, and are exposed for connection to the electrical interconnect assembly.

15. The medical device component of claim 13, wherein:

the medical device component further comprises a connector assembly coupled to a second end of the infusion tube, the connector assembly being configured to fluidly couple the infusion tube to a fluid reservoir of the fluid infusion device, and to electrically couple the sensor conductors to an electronics module of the fluid infusion device.

16. The medical device component of claim 13, the base unit further comprising a connector structure for the conditioned digital sensor data, the connector structure mating with electrical contact pads of the electrical interconnect assembly when the top cover assembly is coupled to the base unit.

17. The medical device component of claim 13, wherein the base unit comprises:

a top surface;

a first hole formed in the top surface, the first hole accommodating the tubing connector, and the first hole accommodating a first insertion needle for inserting the cannula into skin of the patient; and

a second hole formed in the top surface, the second hole accommodating a second insertion needle for inserting the physiological analyte sensor into skin of the patient.

18. The medical device component of claim 13, wherein at least two of the sensor conductors provide operating power from the fluid infusion device to the electronics assembly when the top cover assembly is coupled to the base unit.

19. The medical device component of claim 18, further comprising a battery that provides operating power to the electronics assembly when the top cover assembly is removed from the base unit.