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US-20260124361-A1 - Infusion Set and Inserter Assembly Systems and Methods

US20260124361A1US 20260124361 A1US20260124361 A1US 20260124361A1US-20260124361-A1

Abstract

An inserter assembly comprising a first unit including a skin contacting face which surrounds an opening and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprising a spring biased insertion assembly. The second unit further comprising a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.

Inventors

  • Richard J. Lanigan

Assignees

  • DEKA PRODUCTS LIMITED PARTNERSHIP

Dates

Publication Date
20260507
Application Date
20251231

Claims (14)

  1. 1 . A patient care assembly cartridge for a reusable inserter assembly comprising: a container; a housing including a spring loaded tab, the housing being coupled within the container with the spring loaded tab in a first state and freed from the container with the spring loaded tab deflected from the first state to a deflected state; a retainer body including a cavity, a set of retainer arms, and an end plate having mating pins projecting therefrom for mating to the reusable inserter assembly; a patient care assembly, at least a portion of the patient care assembly being retained by the retainer arms; an insertion sharp; and a sharp holder configured to displace along guides included in the cavity, the insertion sharp being coupled to the sharp holder.
  2. 2 . The cartridge of claim 1 , wherein the spring loaded tab is included on a resilient cantilevered arm.
  3. 3 . The cartridge of claim 1 , wherein the cartridge further comprises a second spring loaded tab opposite the spring loaded tab.
  4. 4 . The cartridge of claim 1 , wherein the patient care assembly is an analyte sensor.
  5. 5 . The cartridge of claim 1 , wherein the patient care assembly is a physiological monitor.
  6. 6 . The cartridge of claim 1 , wherein the patient care assembly is an infusion set, the infusion set including an infusion set base and a cannula subassembly.
  7. 7 . The cartridge of claim 6 , wherein the infusion set base is retained by the retainer arms and the cannula subassembly is disposed on the insertion sharp and is separated from the infusion set base.
  8. 8 . The cartridge of claim 8 , wherein the cannula subassembly includes a set of ears, the retainer arms are configured for displacement to a splayed apart state to release the infusion set base by the ears of the cannula subassembly when the sharp holder is displaced toward the infusion set base.
  9. 9 . The cartridge of claim 1 , wherein the sharp holder includes a terminal flange configured to mate to an insertion driver of the reusable inserter assembly.
  10. 10 . The cartridge of claim 1 , wherein the mating pins are configured to mate with retention shoes included in the inserter assembly.
  11. 11 . The cartridge of claim 1 , wherein the cartridge further comprises an adhesive backing covering adhesive on a portion of the patient care assembly, the housing including an indention in which pull tabs of the adhesive backing are disposed.
  12. 12 . The cartridge of claim 1 , wherein the housing includes a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled.
  13. 13 . The cartridge of claim 12 , wherein the container is configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing.
  14. 14 . The cartridge of claim 1 , wherein the spring loaded tab is configured to displace to the deflected state upon coupling of the cartridge to the inserter assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Division of U.S. patent application Ser. No. 19/296,339, filed Aug. 11, 2025, entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00549.TA013) which is Continuation of U.S. patent application Ser. No. 19/252,054, filed Jun. 27, 2025 entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00538.TA002) which is a Continuation of U.S. patent application Ser. No. 18/662,262, filed on May 13, 2024, now US 2024-0293615, published Sep. 5, 2024, and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00405.AB426) which is a Continuation of U.S. Ser. No. 17/883,063, filed on Aug. 8, 2022, now US 2022-0379019, published Dec. 1, 2022, and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00340.AA927) which is a Continuation of U.S. patent application Ser. No. 16/797,624, filed on Feb. 21, 2020, now U.S. Pat. No. 11,446,434, Issued Sep. 20, 2022, and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00307.AA159) which claims the benefit of U.S. Provisional Application Ser. No. 62/809,248 filed Feb. 22, 2019 and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. Y85), each of which being hereby incorporated herein by reference in their entireties. BACKGROUND Field of Disclosure This application relates generally to infusion sets and inserter assemblies for infusion sets, and more particularly, to infusion sets and inserter assemblies as well as methods for the use thereof. Description of Related Art Many potentially valuable medicines or compounds, including biologicals, are not orally active due to poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally administered, are sometimes required to be taken so often that it is difficult for a patient to maintain the desired schedule. In these cases, parenteral delivery is often employed or could be employed. Effective parenteral delivery routes of drugs, other fluid, and compounds such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration include puncture of the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs may benefit from a wearable device that would automatically deliver needed drugs/compound over a period of time. To this end, there have been efforts to design portable and wearable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from a number of drawbacks including the malfunction rate. Reducing the size, weight, and cost of these devices is also an ongoing challenge. Additionally, these devices often apply to the skin and pose the challenge of frequent relocation for application. SUMMARY In accordance with an embodiment of the present disclosure an inserter assembly may comprise a casing. The inserter assembly may further comprise a body including a cavity disposed within the casing. The inserter assembly may further comprise a sharp holder affixed to an insertion sharp. The sharp holder may be at least partially disposed within the cavity. The inserter assembly may further comprise a bias member within the cavity. The bias member may be positioned between the sharp holder and a wall of the cavity. The inserter assembly may further comprise a trigger having a first state in which the bias member is maintained in an energy storing state and a second state in which the bias member is released from the energy storing state. The bias member may be configured to propel the sharp holder to displace the insertion sharp out of the casing when released from the energy storing state. The inserter assembly may further comprise an infusion set base in retaining engagement with the body. The infusion set base may have an adhesive included on a bottom face thereof. The inserter assembly may further comprise a trigger actuation projection extending from the casing and arranged to actuate the trigger from the first to the second state as the casing is displaced away from a body once the adhesive is stuck to skin and the skin has been tugged a distance away from the body. In some embodiments, the casing may include a housing and a retaining base coupled to the housing so as to move together as a unit with the housing. In some embodiments, the trigger actuation projection may be included on the retaining base. In some embodiments, the trigger may include a latch. In some embodiments the latch may include a catch disposed on the body which engages a ledge formed on a cantilevered arm of the sharp holder. In some embodim