# US 2021/0330751 A1 · Insulins Compatible with New Generation Implantable Pumps > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330751 A1 - Document ID: US20210330751A1 - Status: Published application - Kind: A1 - Application number: 17/368,432 - Filed: 2021-07-06 - Published: 2021-10-28 - Earliest claimed: 2016-11-09 - Applicants: PhysioLogic Devices, Inc. - Inventors: Peter C. Lord; William Van Antwerp - Web page: https://patentgrep.com/patent/US20210330751A1 ## CPC - A61K 38/28: Insulins - A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas} - A61K 47/02: Inorganic compounds - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61M 5/14276: {specially adapted for implantation} - A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure} - 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 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant - A61K 9/5015: {Organic compounds, e.g. fats, sugars} - A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)} - A61M 2025/0073: {Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow} - A61M 2202/07: Proteins - A61M 2205/0244: Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - A61M 2205/3653: by Joule effect, i.e. electric resistance - A61M 2205/368: by electromagnetic radiation, e.g. IR waves - A61M 2205/7518: bacterial - A61M 2205/7581: with means for switching over to a fresh filter on clogging or saturation - A61M 2210/1017: Peritoneal cavity - 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 A closed device for introducing preservative-free insulin into the intraperitoneal space is presented. In embodiments, the closed device includes an insulin reservoir configured to store preservative-free insulin, a pump connected to the reservoir, and an antimicrobial inlet filter connected to an inlet of the reservoir or provided in an inlet flow path in fluid communication with the reservoir. The device is configured to be disposed in the intraperitoneal space of a body, and to discharge preservative-free insulin into a peritoneal space of the body. In some embodiments, the device includes a second antimicrobial filter, provided at an outlet of the reservoir. In some embodiments, the device further includes a header in fluid communication with the outlet path, and a third antimicrobial filter, provided in the header. ## Claims ### Claim 1 A closed device for introducing preservative-free insulin into the intraperitoneal space, comprising: an insulin reservoir configured to store preservative-free insulin; a pump connected to the reservoir; an antimicrobial inlet filter connected to an inlet of the reservoir or provided in an inlet flow path in fluid communication with the reservoir; wherein the device is configured to be disposed in the intraperitoneal space of a body, and to discharge preservative-free insulin into a peritoneal space of the body. ### Claim 2 (depends on 1) The device of claim 1, further comprising a second antimicrobial filter, provided at an outlet of the reservoir. ### Claim 3 (depends on 2) The device of claim 2, further comprising an outlet path, and a header in fluid communication with the outlet path. ### Claim 4 (depends on 3) The device of claim 3, further comprising a third antimicrobial filter, provided in the header. ### Claim 5 (depends on 1) The device of claim 1, further comprising an outlet path, a header in fluid communication with the outlet path, and a second antimicrobial filter, provided in the header. ### Claim 6 A closed device for introducing preservative-free insulin into the intraperitoneal space, comprising: an insulin reservoir configured to store preservative-free insulin; a pump connected to the reservoir; an antimicrobial reservoir outlet filter connected to an outlet of the reservoir; wherein the device is configured to be disposed in the intraperitoneal space of a body, and to discharge, preservative-free insulin into a peritoneal space of the body. ### Claim 7 (depends on 6) The device of claim 6, further comprising a second antimicrobial filter, provided at an inlet of the reservoir or in an inlet flow path in fluid communication with the reservoir. ### Claim 8 (depends on 7) The device of claim 7, further comprising an outlet path, and a header in fluid communication with the outlet path. ### Claim 9 (depends on 8) The device of claim 8, further comprising a third antimicrobial filter, provided in the header. ### Claim 10 (depends on 6) The device of claim 6, further comprising an outlet path, a header in fluid communication with the outlet path, and a second antimicrobial filter, provided in the header. ### Claim 11 (depends on 1) The device of claim 1, wherein the insulin in the reservoir is stabilized with zinc, and the zinc is removed prior to discharge of the insulin into a body by at least one of (i) reducing the zinc as the insulin passes through electrodes provided in the catheter lumen, (ii) chelation, or (iii) passive reduction using a material having a higher negative electrochemical potential than zinc. ### Claim 12 (depends on 11) The device of claim 11, wherein at least one of: the zinc is removed prior to discharge by passive reduction using a material having a higher negative electrochemical potential than zinc; the zinc is removed prior to discharge by passive reduction using one of manganese or magnesium; or the zinc is removed prior to discharge by a combination of active and passive reduction. ### Claim 13 A method of providing osmotic pressure at the tip of a catheter used to discharge insulin via a reservoir, pump and catheter into the intraperitoneal space, comprising: providing a semi-permeable membrane in the catheter; providing insulin in the reservoir so that it is hypertonic relative to tissue surrounding the catheter; and passing the hypertonic insulin through catheter walls comprising a semi permeable membrane material, such that water is driven into the catheter by osmosis so as to generate a defined osmotic pressure at the tip of the catheter, said osmotic pressure pi defined as π=MRT, wherein: M is the molar concentration of dissolved species (units of mol/L); R is the ideal gas constant (0.08206 L atm mol−1 K−1, or other values depending on the pressure units); and T is the temperature on the Kelvin scale. ### Claim 14 (depends on 13) The method of claim 13, further comprising adding an additive to the insulin to increase the osmotic effect. ### Claim 15 (depends on 14) The method of claim 14, wherein the additive is polyethylene glycol (PEG).