Infusion sets for the delivery of a therapeutic substance to a patient

• US 9,669,156 B2
• Filed: 08/15/2016
• Issued: 06/06/2017
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jennewine, R. Curtis
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US15/237,174
• Publication Number:
  US 20160346457A1
• Time in Patent Office: 295 Days
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2005/3201 Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2205/0205 : Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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 5/158 : 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: B05D 5/00 : Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures

Abstract

Devices and methods for delivering a therapeutic substance to a patient are provided. Embodiments include infusion sets that include an active agent. Also provided are systems and kits.

Claims

1. A method of using an infusion system comprising an inner cannula configured to deliver a medication to a patient and an outer cannula configured to reside over the inner cannula and to deliver the medication to the patient, wherein the method comprises:

positioning the inner cannula and the outer cannula together under the skin of the patient;

using one of the inner cannula or the outer cannula to deliver the medication to the patient;

withdrawing the used cannula from the patient while leaving the other cannula within the patient to deliver the medication; and

delivering the medication through the other cannula.

2. The method of claim 1, wherein the medication is insulin.

3. The method of claim 2, wherein using one of the inner cannula or the outer cannula to deliver the medication to the patient comprises using one of the inner cannula or the outer cannula to deliver the insulin into subcutaneous tissue of the patient.

4. The method of claim 1, comprising:

using the inner cannula to deliver the medication to the patient;

withdrawing the inner cannula from the patient while leaving the outer cannula within the patient; and

then delivering the medication through the outer cannula.

5. The method of claim 4, wherein the inner and outer cannulas are coupled with an on-body device that is also coupled with a sensor, the method comprising:

positioning the sensor in the patient; and

sensing an analyte level of the patient with the sensor.

6. The method of claim 5, wherein the infusion system comprises a pump and a sensor control unit in electrical communication with the sensor, wherein the pump is configured to automatically receive information indicative of the analyte level from the sensor control unit.

7. The method of claim 4, wherein positioning the inner cannula and the outer cannula together under the skin of the patient comprises positioning an end of the inner cannula and an end of the outer cannula under the skin of the patient, wherein the end of the inner cannula is at a greater depth under the skin than the end of the outer cannula.

8. The method of claim 1, comprising:

using the outer cannula to deliver the medication to the patient;

withdrawing the outer cannula from the patient while leaving the inner cannula within the patient; and

then delivering the medication through the inner cannula.

9. The method of claim 8, wherein the inner and outer cannulas are coupled with an on-body device that is also coupled with a sensor, the method comprising:

positioning the sensor in the patient; and

sensing an analyte level of the patient with the sensor.

10. The method of claim 9, wherein the infusion system comprises a pump and a sensor control unit in electrical communication with the sensor, wherein the pump is configured to automatically receive information indicative of the analyte level from the sensor control unit.

11. The method of claim 8, wherein positioning the inner cannula and the outer cannula together under the skin of the patient comprises positioning an end of the inner cannula and an end of the outer cannula under the skin of the patient, wherein the end of the outer cannula is at a greater depth under the skin than the end of the inner cannula.

12. The method of claim 1, wherein the infusion system further comprises a securement element and an implantable sensor for monitoring an analyte level, the method comprising securing the implantable sensor, the inner cannula, and the outer cannula to the patient with the securement element.

13. The method of claim 1, wherein the infusion set further comprises tubing configured for fluid communication between a source of the medication and the inner or outer cannula.

14. The method of claim 1, wherein an active agent comprising an anti-scarring agent or both an antimicrobial agent and an anti-scarring agent is present on at least one component of the infusion system.

15. The method of claim 14, further comprising controllably releasing the active agent over a predetermined time period by use of a non-active agent.

16. The method of claim 15, wherein the non-active agent comprises a polymer.

17. The method of claim 16, wherein the polymer partially degrades or disintegrates over the predetermined time period to release the active agent.

18. The method of claim 15, wherein the non-active agent provides a diffusion layer between the patient and the inner or outer cannula.

19. The method of claim 15, wherein the active agent is present on the outer cannula.

20. The method of claim 15, wherein the active agent is present on an outer surface of the outer cannula and on an outer surface of the inner cannula.