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

• US 8,353,881 B2
• Filed: 12/28/2005
• Issued: 01/15/2013
• 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): Shumate, Victoria P
• Application Number:
  US11/322,166
• Publication Number:
  US 20090105658A1
• Time in Patent Office: 2,575 Days
• Field of Search: 604/272, 604/265, 604/523
• US Class Current: 604/265
• 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 system for delivering a therapeutic fluid to a patient, the system comprising:

an infusion set comprising at least one transcutaneous cannula configured for delivering the therapeutic fluid to within the patient;

a securement element for securing the infusion set to the patient;

an implantable sensor for monitoring an analyte wherein the sensor is physically associated with the securement element;

an active agent comprising at least one of an antimicrobial agent or an anti-scarring agent or both an antimicrobial agent and an anti-scarring agent; and

a non-active agent for controllably releasing the active agent over a predetermined time period.

2. The system of claim 1, wherein the active agent is provided on at least a portion of the infusion set.

3. The system of claim 1, wherein the active agent is applied by one or more of spraying, dipping or coating the at least one cannula.

4. The system of claim 1, wherein the active agent is provided on the securement element.

5. The system of claim 1, wherein the infusion set further comprises an insertion element for inserting the at least one cannula into the patient.

6. The system of claim 5, wherein the active agent is provided on the insertion element.

7. The system of claim 1, wherein the infusion set further comprises tubing configured for fluid communication between a source of the therapeutic fluid and the at least one cannula.

8. The system of claim 7, wherein the active agent is provided on the tubing.

9. The system of claim 1, wherein the active agent is provided on the implantable sensor.

10. The system of claim 1, wherein the active agent is a coating.

11. The system of claim 10, wherein the coating comprises multiple coats of the active agent.

12. The system of claim 1, wherein the active agent is integrated into the material of the infusion set.

13. The system of claim 1, wherein the antimicrobial agent comprises at least one of penicillin, mupirocin, erthromycin, polymyxin, silver sulfadiazine, cephalosporins, bacitracin, tetracycline, doxycycline, gentamycin, quinolines, neomycin, clindamycin, kanamycin, metronidazole, iodine, Povidine-iodine, benzalkonium chloride, benzoic acid, chlorhexidine, nitrofurazone, benzoyl peroxide, hydrogen peroxide, hexachlorophene, phenol, resorcinol, and cetylpyridinium chloride, nystatin, ciclopirox, chloroxylenol, triacetin, sulconazole, undecylenic acid, tolnaftate, miconizole, clotrimazole, oxiconazole, griseofulvin, econazole, ketoconozole, and amphotericin B, acyclovir, ribarivin, interferons, nitrofurazone, iodine, silver nitrate, silver sulfadiazine, zinc oxide, or combinations thereof.

14. The system of claim 1, wherein the therapeutic fluid comprises insulin and the sensor comprises a glucose sensor.

15. The system of claim 14, further comprising an insulin delivery device wherein the system is configured to communicate glucose information from the glucose sensor to the insulin delivery device.

16. The system of claim 15, wherein the system is configured to automatically communicate the glucose information from the glucose sensor to the insulin delivery device.

17. The system of claim 15, wherein the insulin delivery device is configured to determine an amount of insulin to be delivered based on the glucose information from the glucose sensor.

18. The system of claim 1, wherein the non-active agent comprises a polymer.

19. The system of claim 18, wherein the polymer is configured to at least partially degrade or disintegrate over the predetermined time period.

20. The system of claim 1, wherein the non-active agent provides a diffusion layer between the patient and the at least one cannula.

21. The system of claim 1, wherein the predetermined time period comprises at least approximately three days.

22. The system of claim 1, wherein the securement element comprises a skin-contacting surface substantially transverse to the at least one cannula.

23. The system of claim 22, wherein the skin-contacting surface of the securement element is substantially transverse to the implantable sensor.

24. The system of claim 22, wherein the skin-contacting surface of the securement element provides the active agent.

25. The system of claim 22, wherein the skin-contacting surface comprises an adhesive.

26. The system of claim 1, wherein the at least one transcutaneous cannula comprises an inner cannula and an outer cannula wherein a portion of the inner cannula is disposed within the outer cannula.

27. The system of claim 26, wherein the inner cannula and the outer cannula are configured to be simultaneously inserted through a skin layer of the patient.

28. The system of claim 26, wherein the inner cannula and the outer cannula are configured to be separately inserted through a skin layer of the patient.

29. The system of claim 26, wherein the inner cannula and the outer cannula are configured to be positioned at a respective first location and a second location under the skin layer.

30. The system of claim 29, wherein the first location and the second location are different.

31. The system of claim 30, wherein the first location is at a greater depth than the second location.

32. The system of claim 30, wherein the second location is at a greater depth than the first location.

33. The system of claim 26, wherein the inner cannula and the outer cannula are configured to be withdrawn from the patient at respective different times.

34. The system of claim 26, wherein the active agent is provided on the outer cannula.

35. The system of claim 26, wherein the active agent is applied to an outer surface of the outer cannula and to an outer surface of the inner cannula excluding the outer surface of the portion of the inner cannula that is disposed within the outer cannula.