IP Library › Granted Patent US 12,214,159
Granted Patent B2
US 12,214,159 · App. 17/446,271 · Granted Feb 4, 2025

Insulin infusion set

Inventors: Keith A. Oberg (Newhall, CA); Mark C. Estes (Malibu, CA); Kenneth C. Hsu (Tustin, CA); David S. Gillett (San Diego, CA)
Assignee: Tandem Diabetes Care, Inc
A61M5/158A61M5/14248A61M2005/14252A61M2005/1585A61M2005/1587
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Quick Facts
Patent No.
US 12,214,159
App. No.
17/446,271
Granted
Feb 4, 2025
Kind
B2
Abstract

Embodiments of devices and methods to maintain preservative concentration in a medication delivered using a medical device are provided. A barrier layer can be used to prevent migration of preservatives. A vent can be used to allow release of preservatives prior to delivery to the patient. An absorbent element can be used to maintain preservative concentration at a desired level. A filter can be used to capture particulates from the medication prior to delivery to a patient.

Claims (63)

1. An insulin delivery system comprising:

a reservoir configured to hold an insulin medication therein;

an infusion hub;

tubing connecting the insulin reservoir and the infusion hub;

a cannula configured to deliver the insulin medication to a patient; and

a filter configured to capture particulates from the insulin medication prior to delivery of the insulin to the patient, wherein the filter comprises an internal coil within the cannula.

2. The insulin delivery system of claim 1 , wherein the internal coil comprises a round wire.

3. The insulin delivery system of any of claim 1 , wherein the internal coil comprises a flat wire.

4. The insulin delivery system of any of claim 1 , wherein the internal coil comprises an engineering polymer.

5. The insulin delivery system of any of claim 1 , wherein the internal coil comprises stainless steel.

6. The insulin delivery system of any of claim 1 , wherein the filter comprises a structural component to prevent crushing or kinking of the extruded cannula.

7. The insulin delivery system of claim 1 , further comprising an absorbent element positioned within the delivery system and in fluidic contact with the insulin medication, the absorbent element configured to absorb and store preservatives from the insulin medication.

8. The insulin delivery system of claim 7 , further comprising an impermeable backing layer adjacent to the absorbent element and configured to maintain the preservatives within the absorbent.

9. The insulin delivery system of any of claim 7 , wherein the absorbent element comprises EVOH, silicone, a low-density polymer, a PEG block-copolymer (e.g., PETG), PET, nylon, a nylon block-copolymer, a polymeric foam, or a polymeric monolith.

10. The insulin delivery system of claim 7 , wherein the absorbent comprises a preservative capacity greater than a maximum concentration of preservative in the insulin medication.

11. The insulin delivery system of claim 7 , wherein the absorbent is further configured to release preservatives to the insulin medication after storing the preservatives.

12. The insulin delivery system of claim 7 , wherein the absorbent is configured to maintain the preservative concentration at the point of delivery to the patient at a concentration that minimizes local toxicity while maintaining insulin in a stable hexameric state.

13. The insulin delivery system of claim 7 , wherein the absorbent comprises an interior layer of the tubing.

14. The insulin delivery system of any of claim 1 , wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservatives from the insulin medication.

15. The insulin delivery system of claim 14 , wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of a layer of the multi-layer tubing.

16. The insulin delivery system of claim 14 , wherein the tubing is a multi-layer tubing, and wherein the barrier layer forms an entire layer of the multi-layer tubing.

17. The insulin delivery system of claim 14 , wherein the barrier layer comprises a coating on the tubing.

18. The insulin delivery system of claim 14 , wherein the barrier layer comprises an inner layer of the tubing.

19. The insulin delivery system of claim 14 , wherein the barrier layer comprises polyether block-amide, HDPE, polypropylene, PTFE, chloro- and fluorosilicones, hydrochloro-, hydrofluoro-, and perfluoro-polymers, chlorinated polymers (e.g. viton), metal-coated polymers (e.g., mylar), poly carbonate, organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides), vapor-deposited coatings (such as nitrides, titanium nitride, fluorocarbons, metals), Kapton, or parylene.

20. The insulin delivery system of claim 14 , further comprising a barrel connected to the cannula, and wherein the barrier layer is positioned on at least a portion of the barrel.

21. The insulin delivery system of claim 14 , comprising a connector comprising the barrier layer.

22. The insulin delivery system of claim 14 , wherein the barrier layer extends through an entire fluid path of the system.

23. The insulin delivery system of claim 14 , further comprising a vent in the tubing or the hub configured to release preservatives from the insulin medication prior to delivery of the insulin medication to the patient.

24. The insulin delivery system of claim 23 , wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservatives from the insulin medication and wherein the vent comprises an opening in the barrier layer.

25. The insulin delivery system of claim 23 , wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservatives from the insulin medication and wherein the vent comprises a portion of the barrier layer that is thinner than other portions of the barrier layer.

26. An insulin delivery system comprising:

a reservoir configured to hold an insulin medication therein;

an infusion hub;

tubing connecting the insulin reservoir and the infusion hub;

a cannula configured to deliver the insulin medication to a patient; and

a filter configured to capture particulates from the insulin medication prior to delivery of the insulin to the patient,

wherein the filter comprises features internal to the cannula and in fluidic contact with the insulin configured to affect hydrodynamic flow characteristics of insulin medication flowing within the cannula and to create pressure differential regimes to promote the capture and retention of aggregate particles that have formed out of solution.

27. The insulin delivery system of any of claim 26 , wherein the features comprise internally molded features within the cannula.

28. The insulin delivery system of any of claim 26 , wherein the features comprise internally extruded features within the cannula.

29. The insulin delivery system of any of claim 26 , wherein the filter comprises a threaded inner surface of the cannula.

30. The insulin delivery system of claim 26 , wherein the features repeat along at least a portion of a length of the cannula.

31. The insulin delivery system of claim 30 , wherein a ratio of a width of the features and a period of the features is greater than about 1:1 and less than about 1:4.

32. A method for delivering insulin, comprising:

providing a delivery system;

delivering insulin medication comprising preservatives from a reservoir through tubing connecting the reservoir to an infusion hub;

filtering the insulin medication to capture particulates from the insulin medication prior to delivery of the insulin medication to the patient; and

delivering the insulin medication to the patient through a cannula connected to the infusion hub,

wherein filtering the insulin medication comprises using a coil internal to the cannula, the coil configured to create a region of features affecting hydrodynamic flow characteristics of insulin medication flowing within the cannula and creating differential pressure regimes to promote the capture and retention of aggregate particles that have formed out of solution.

33. The method of claim 32 , wherein the coil comprises a round wire.

34. The method of claim 32 , wherein the coil comprises a flat wire.

35. The method of claim 32 , further comprising exposing the insulin medication to an absorbent element configured to store preservatives from the insulin medication.

36. The method of claim 35 , further comprising the absorbent element absorbing preservatives from the insulin medication.

37. The method of claim 35 , further comprising the absorbent element releasing preservatives back into the insulin medication.

38. The method of claim 35 , further comprising preventing preservative evaporation using a barrier layer on one or more components of the delivery system.

39. The method of claim 32 , further comprising venting the insulin medication, thereby releasing preservatives from the insulin medication.

40. The method of claim 39 , further comprising preventing preservative loss from the insulin medication by providing a barrier layer along at least a portion of the fluid path of the delivery system, and wherein venting the insulin medication comprises exposing the insulin medication to an opening in the barrier layer.

41. The method of claim 39 , further comprising preventing preservative loss from the insulin medication by providing a barrier layer along at least a portion of the fluid path of the delivery system, and wherein venting the insulin medication comprises exposing the insulin medication to a portion of the barrier layer that is thinner than other portions of the barrier layer.

42. A method for delivering insulin, comprising:

providing a delivery system;

delivering insulin medication comprising preservatives from a reservoir through tubing connecting the reservoir to an infusion hub;

filtering the insulin medication to capture particulates from the insulin medication prior to delivery of the insulin medication to the patient; and

delivering the insulin medication to the patient through a cannula connected to the infusion hub,

wherein filtering the insulin medication comprises providing, within a flow path of the insulin medication, features internal to the cannula, thereby affecting hydrodynamic flow characteristics of insulin medication flowing within the cannula and creating differential pressure regimes to promote the capture and retention of aggregate particles that have formed out of solution.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2022
From: CAPILLARY BIOMEDICAL, INC.
To: TANDEM DIABETES CARE, INC.
Reel/Frame 060849/0752 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2022
From: OBERG, KEITH A.; ESTES, MARK C.; HSU, KENNETH C.; GILLETT, DAVID S.
To: CAPILLARY BIOMEDICAL, INC.
Reel/Frame 059995/0873 →
Continuity (2)
Provisional Application 63071994 · Aug 28, 2020
Related Publication 20220226568A1 · Jul 21, 2022
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