# US 12,208,181 B2 · Medication infusion components and systems

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- Number: US 12,208,181 B2
- Document ID: US12208181B2
- Status: Granted
- Kind: B2
- Application number: 17/823,388
- Filed: 2022-08-30
- Published: 2022-12-29
- Granted: 2025-01-28
- Earliest claimed: 2017-01-19
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic Minimed, Inc.
- Inventors: Kiem H. Dang; Sarnath Chattaraj; Hsi C. Fusselman; Lance P. Hoffman; Guangping Zhang
- Web page: https://patentgrep.com/patent/US12208181B2

## CPC

- A61L 29/146: {Porous materials, e.g. foams or sponges}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/727: Heparin; Heparan
- A61K 38/28: Insulins
- A61L 29/049: {Mixtures of macromolecular compounds}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/14276: {specially adapted for implantation}
- A61M 5/165: Filtering accessories, e.g. blood filters, filters for infusion liquids (A61M1/34, A61M5/36 take precedence)
- A61M 5/38: using hydrophilic or hydrophobic filters
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 39/10: Tube connectors or tube couplings
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking}
- A61M 2039/0241: {having means for filtering}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0276: {for introducing or removing fluids into or out of the body}
- A61M 2205/0272: Electro-active or magneto-active materials
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/584: having a color code
- A61M 2205/7545: for solid matter, e.g. microaggregates
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2230/201: Glucose concentration
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

This invention pertains to systems and components useful for infusing medications such as insulin. Typically, the components are used to deliver insulin to a diabetic patient at a site of infusion over a period of time greater than 4 days. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.

## Claims

### Claim 1

A system for delivering a fluid medication to a patient at an infusion site, the system comprising:
a fluid conduit configured to transport the fluid medication from a reservoir to the patient;
a depot in operable contact with the fluid conduit and having a foam/sponge material disposed therein, wherein the foam/sponge material:
comprises pores having sizes between 0.1 and 5 mm,
comprises a porosity between 50 and 95%,
absorbs an aqueous solution so as to saturate the foam/sponge material by at least 95% in a time between 0.1 and 1 minutes, and
traps aggregates that form in the fluid medication; and
a cannula configured to be in operable contact with the fluid conduit and the depot, and wherein the cannula is configured for subcutaneous insertion into a tissue of the patient at the infusion site.

### Claim 2 (depends on 1)

The system of claim 1, wherein the fluid medication is insulin, and wherein the depot is configured to trap insulin aggregates that form in the insulin.

### Claim 3 (depends on 2)

The system of claim 2, wherein the system is configured to infuse the insulin to the patient at the infusion site over a period of time greater than one day.

### Claim 4 (depends on 1)

The system of claim 1, wherein the foam/sponge material comprises polyvinyl alcohol, a cellulose, a polyurethane, a polyester, a polyether, or a collagen.

### Claim 5 (depends on 1)

The system of claim 1, further comprising a membrane in operable contact with the fluid conduit, wherein the membrane is:
formed from a material having pores that are between 0.1 μm to 10 μm in diameter, and
configured to filter/trap particulates or aggregates in the fluid medication.

### Claim 6 (depends on 5)

The system of claim 5, wherein the fluid medication is insulin.

### Claim 7 (depends on 5)

The system of claim 5, wherein the membrane comprises at least one of an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose esters membrane, a cellulose acetate membrane, a cellulose nitrate membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and/or a polycarbonate membrane.