Fluid delivery device and transcutaneous access tool with blood glucose monitoring for use therewith

• US 10,124,112 B2
• Filed: 04/01/2013
• Issued: 11/13/2018
• Est. Priority Date: 03/30/2012
• Status: Active Grant

• Current Assignee: Insulet Corporation, Sanvita Medical Corporation
• Original Assignee: Insulet Corporation, Nova Biomedical Corporation (Nova Chemicals)
• Inventors: DiIanni, Steven, McLaughlin, Ian, O'Connor, Jason Brian, Campbell, Robert, Schmid, Kevin, Peterson, Thomas
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US13/854,463
• Publication Number:
  US 20140128839A1
• Time in Patent Office: 2,052 Days
• Field of Search: 604 65, 604 66, 604504, 60416411, 6048911, 600316, 600365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: F04B 9/02 the means being mechanical
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

An infusion device comprising a fluid reservoir for containing a therapeutic fluid; and a transcutaneous access tool fluidly coupled to the fluid reservoir for delivering the therapeutic fluid subcutaneously and for introducing a monitoring test strip subcutaneously, and methods of use thereof.

Claims

1. An infusion device, the device comprising:

a housing, the housing containing a fluid reservoir, a monitoring test strip, a transcutaneous access tool, and a transcutaneous access tool insertion mechanism;

the fluid reservoir to contain a therapeutic fluid;

the transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously and the monitoring test strip subcutaneously;

the transcutaneous access tool including a cannula having a length, a first lumen and a second lumen, the first lumen having a longitudinal axis extending along the length of the cannula and the second lumen having a longitudinal axis extending along the length of the cannula, wherein the first lumen longitudinal axis and the second lumen longitudinal axis are different axes;

the first lumen of the cannula fluidly coupled with the fluid reservoir, and a deployable and retractable needle/trocar located within the first lumen;

the second lumen of the cannula containing the monitoring test strip;

the transcutaneous access tool insertion mechanism configured to extend and insert the cannula together with the needle/trocar subcutaneously upon deployment of the needle/trocar, and thereafter retract the needle/trocar within the cannula while the cannula remains inserted subcutaneously;

the transcutaneous access tool configured such that, when the therapeutic fluid from the fluid reservoir is delivered through the first lumen of the cannula, the needle/trocar including a distal end thereof is contained within the first lumen of the cannula;

the cannula together with the needle/trocar being extendable, and the needle/trocar being retractable, with energy stored in the transcutaneous access tool insertion mechanism.

2. The infusion device of claim 1 wherein the fluid reservoir comprises an insulin reservoir, and wherein the monitoring test strip comprises a continuous glucose monitoring test strip.

3. The infusion device of claim 1 wherein the energy stored in the transcutaneous access tool insertion mechanism is stored in a spring.

4. The infusion device of claim 1 wherein the transcutaneous access tool includes a cannula, a first needle/trocar passing through a lumen of the cannula, and a second needle/trocar configured to introduce the monitoring test strip subcutaneously.

5. The infusion device of claim 4 wherein the needle/trocar is configured to introduce the monitoring test strip subcutaneously solely without the monitoring test strip being introduced with a cannula.

6. The infusion device of claim 1 wherein the transcutaneous access tool includes first and second cannulas, a first needle/trocar passing through a lumen of the first cannula, and a second needle/trocar passing through a lumen of the second cannula, and wherein the monitoring test strip is located in the second cannula.

7. The infusion device of claim 6 wherein the second needle/trocar passing through a lumen of the second cannula is a trocar having a planar surface and the monitoring test strip comprises a planar strip, and wherein the planar strip is located adjacent the planar surface of the trocar in the second cannula.

8. The infusion device of claim 6 wherein the second cannula includes at least one window for exposing a sensor area on the monitoring test strip subcutaneously.

9. The infusion device of claim 8 wherein the at least one window of the cannula includes a plurality of windows, and wherein at least one window exposes a sensor of the monitoring test strip.

10. The infusion device of claim 8 wherein the plurality of windows of the cannula include a first window arranged at a first distance from a tip of the cannula and a second window arranged at a second distance from the tip of the cannula, wherein the first distance is less than the second distance.

11. The infusion device of claim 1 wherein the cannula includes at least one window for exposing a sensor area of the monitoring test strip subcutaneously.

12. The infusion device of claim 11 wherein the at least one window of the cannula includes a plurality of windows, and wherein at least one window exposes a sensor of the monitoring test strip.

13. The infusion device of claim 12 wherein the plurality of windows of the cannula include a first window arranged at a first distance from a tip of the cannula and a second window arranged at a second distance from the tip of the cannula, wherein the first distance is less than the second distance.

14. A method to treat diabetes mellitus comprising:

providing an infusion device, the device comprising,

a housing, the housing containing a fluid reservoir, a monitoring test strip, a transcutaneous access tool, and a transcutaneous access tool insertion mechanism;

the fluid reservoir to contain a therapeutic fluid;

the transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously and the monitoring test strip subcutaneously;

the transcutaneous access tool including a cannula having a length, a first lumen and a second lumen, the first lumen having a longitudinal axis extending along the length of the cannula and the second lumen having a longitudinal axis extending along the length of the cannula, wherein the first lumen longitudinal axis and the second lumen longitudinal axis are different axes;

the first lumen of the cannula fluidly coupled with the fluid reservoir, and a deployable and retractable needle/trocar located within the first lumen;

the second lumen of the cannula containing the monitoring test strip;

the transcutaneous access tool insertion mechanism configured to extend and insert the cannula together with the needle/trocar subcutaneously upon deployment of the needle/trocar and thereafter retract the needle/trocar within the cannula while the cannula remains inserted subcutaneously;

the transcutaneous access tool configured such that, when the therapeutic fluid from the fluid reservoir is delivered through the first lumen of the cannula, the needle/trocar including a distal end thereof is contained within the first lumen of the cannula; and

the cannula together with the needle/trocar being extendable, and the needle/trocar being retractable, with energy stored in the transcutaneous access tool insertion mechanism; and

delivering the therapeutic fluid subcutaneously to a patient with the transcutaneous access tool, and introducing the monitoring test strip subcutaneously to the patient with the transcutaneous access tool.

15. The method of treating diabetes mellitus of claim 14 wherein:

the transcutaneous access tool includes cannula, a first needle/trocar passing through a lumen of the cannula, and a second needle/trocar trocar including the monitoring test strip;

inserting the first needle/trocar and the cannula subcutaneously into the patient, retracting the first needle/trocar from the patient and providing the therapeutic fluid through the lumen of the cannula to deliver the therapeutic fluid subcutaneously to a patient;

inserting the second/needle trocar with the monitoring test strip subcutaneously into the patient to introduce the monitoring test strip subcutaneously to the patient.

16. The method of treating diabetes mellitus of claim 14 wherein the energy stored in the transcutaneous access tool insertion mechanism is stored in a spring.

17. The method of treating diabetes mellitus of claim 14 wherein:

the monitoring test strip is located in a second lumen of the cannula, and further comprising

inserting the needle/trocar and the cannula subcutaneously into the patient;

retracting the needle/trocar from the patient; and

providing the therapeutic fluid through the first lumen of the cannula to deliver the therapeutic fluid subcutaneously to a patient.

18. The method of treating diabetes mellitus of claim 17 wherein

the cannula includes at least one window which exposes a sensor of the monitoring test strip to blood of the patient, and further comprising

receiving data from the sensor concerning a glucose level of the patient, and

determining an output of the therapeutic fluid from the reservoir based on the glucose level.

19. The method of treating diabetes mellitus of claim 14 wherein:

the transcutaneous access tool includes first and second cannulas, a first needle/trocar passing through a lumen of the first cannula, and a second needle/trocar passing through a lumen of the second cannula, wherein the monitoring test strip is located in the second cannula and further comprising

inserting the first needle/trocar and the first cannula subcutaneously into the patient, retracting the first needle/trocar from the patient and providing the therapeutic fluid through the lumen of the first cannula to deliver the therapeutic fluid subcutaneously to a patient;

inserting the second needle/trocar, the monitoring test strip and the second cannula subcutaneously into the patient to introduce the monitoring test strip subcutaneously to the patient.

20. The method of treating diabetes mellitus of claim 19 wherein:

the second cannula includes at least one window which exposes a sensor of the monitoring test strip to blood of the patient, and further comprising

receiving data from the sensor concerning a glucose level of the patient, and

determining an output of the therapeutic fluid from the reservoir based on the glucose level.