Infusion set with components comprising a polymeric sorbent to reduce the concentration of m-cresol in insulin

Patent metadata

Field	Value
Publication number	US-2019054233-A1
Application number	US-201716094628-A
Country	US
Kind code	A1
Filing date	Apr 21, 2017
Priority date	Apr 22, 2016
Publication date	Feb 21, 2019
Grant date	—

Abstract

An insulin infusion set (IIS) device with one or more features designed to achieve longevity in a patients continuous subcutaneous insulin infusion (CSII) site viability. One exemplary feature is an adsorbent material configured to adsorb phenolic excipients (e.g., m-cresol or other preservatives) from the insulin formulation. The adsorbent material may be positioned along a fluid pathway specifically designed to increase and/or extend exposure between the insulin formulation and the adsorbent material. Another exemplary feature is a medicament configured to reduce the patients inflammation or slow the progression of the patients inflammatory response. Yet another exemplary feature is a diffusive catheter configured to deliver the insulin formulation in a diffuse manner.

First claim

What is claimed is:

1 . An insulin infusion set device comprising:
a flexible tubing configured to receive an insulin formulation containing at least one phenolic excipient; a base coupled to the tubing and configured to receive the insulin formulation; a catheter coupled to the base and configured to deliver the insulin formulation to a patient; and at least one polymeric sorbent material in fluid communication with the insulin formulation in the device, the at least one polymeric sorbent material being configured to collect the at least one phenolic excipient from the insulin formulation.

2 . The device of claim 1 , wherein the at least one phenolic excipient is m-cresol, and the at least one polymeric sorbent material is capable of collecting 10% or more of the m-cresol.

3 . The device of claim 1 , wherein the at least one polymeric sorbent material has at least one phenyl ring in a backbone of the polymer.

4 . The device of claim 3 , wherein the at least one polymeric sorbent material is an aromatic polyester-based thermoplastic polyurethane (TPU).

5 . The device of claim 1 , wherein the at least one polymeric sorbent material has at least one phenyl ring in a side chain of the polymer.

6 . The device of claim 5 , wherein the at least one polymeric sorbent material is a poly(styrene-ethylene-butylene-styrene) (SEBS) copolymer.

7 . The device of claim 1 , wherein the at least one polymeric sorbent material is located at a distal end of the device such that the at least one phenolic excipient is collected before the insulin formulation is delivered to the patient.

8 . The device of claim 1 , wherein the at least one polymeric sorbent material is located in a tortuous fluid pathway of the device.

9 . The device of claim 8 , wherein the tortuous fluid pathway is located in the tubing of the device, the tubing being constructed of or coated with the at least one polymeric sorbent material.

10 . The device of claim 8 , wherein the tortuous fluid pathway is located in the base of the device, the base being constructed of or coated with the at least one polymeric sorbent material.

11 . The device of claim 1 , wherein the at least one polymeric sorbent material is located in a fluid pathway of the device having a non-circular cross-section.

12 . The device of claim 1 , wherein the at least one polymeric sorbent material is located on at least one of a bed of microbeads, a porous filtration membrane, and a bed of microfibers.

13 . The device of claim 1 , further comprising a medicament comprising at least one anti-inflammatory agent coupled to the device in fluid communication with the insulin formulation.

14 . The device of claim 1 , wherein an outer surface of the catheter includes a plurality of apertures configured to deliver the insulin formulation to the patient in a diffuse manner.

15 . An insulin infusion set device comprising:
a flexible tubing; a base coupled to the tubing; a catheter coupled to the base; a tortuous fluid pathway configured to transport an insulin formulation containing at least one phenolic excipient through the device; and at least one sorbent material positioned along the tortuous fluid pathway, the at least one sorbent material being configured to collect the at least one phenolic excipient from the insulin formulation.

16 . The device of claim 15 , wherein the at least one sorbent material is a polymer.

17 . The device of claim 16 , wherein the at least one polymeric sorbent material is an aromatic polyester-based thermoplastic polyurethane (TPU) or a poly(styrene-ethylene-butylene-styrene) (SEBS) copolymer.

18 . The device of claim 15 , wherein the tortuous fluid pathway is located in the tubing and defined by a plurality of internal obstacles in the tubing.

19 . The device of claim 15 , wherein the tortuous fluid pathway is located in the base and has a zig-zag arrangement.

20 . An insulin infusion set device comprising:
a flexible tubing; a base coupled to the tubing; a catheter coupled to the base; a fluid pathway configured to transport an insulin formulation containing m-cresol through the device; and at least one polymeric sorbent material positioned along the fluid pathway, the at least one sorbent material being capable of collecting 10% or more of the m-cresol:

21 . The device of claim 20 , wherein a surface that defines the fluid pathway is constructed of or coated with the at least one polymeric sorbent material.

22 . The device of claim 20 , wherein the at least one polymeric sorbent material is selected from the group consisting of aromatic polyester-based thermoplastic polyurethane, polysulfone, poly(phenyl methyl siloxane), poly(diphenyl siloxane), polystyrene, poly (styrene-ethylene-butylene-styrene), nylon 66, ethylene vinyl alcohol, polychlorotrifluoroethylene, poly(acrylonitrile), poly(vinylidene chloride), polyisoprene, butyl rubber, chlorobutyl rubber, polypropylene (PP), and silicone.

Assignees

• Lilly Co Eli

Inventors

• Demaria Christopher John
• Hartmann Daniel Morris
• Jones Graham Barry
• Kovalchick Christopher
• Pszenny Sean Matthew
• Sirkar Rhea
• Swinney Monica Rixman

Classifications

• B01J2220/64

  In a syringe, pipette, e.g. tip or in a tube, e.g. test-tube or u-shape tube · CPC title

• A61M2005/1587

  suitable for being connected to an infusion line after insertion into a patient · CPC title

• B01J20/264

  derived from different types of monomers, e.g. linear or branched copolymers, block copolymers, graft copolymers · CPC title

• B01J20/262

  obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. obtained by polycondensation (macromolecular compounds obtained otherwise than by reactions only involving unsaturated carbon-to-carbon bonds per se C08G) · CPC title

• A61K38/28

  Insulins · CPC title