US-20260124360-A1 - INFUSION SET AND INSERTER ASSEMBLY SYSTEMS AND METHODS

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state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.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 (13)

1. 1 . A cartridge for a reusable inserter assembly comprising: a container; a housing releasably coupled within the container, the housing including a bay; an infusion set base disposed within the bay; a retainer body including a set of cantilevered arms and a cavity, the infusion set base releasably coupled to the retainer body via the set of cantilevered arms; a sharp holder having an insertion sharp coupled thereto, the sharp holder configured for displacement along guides included in the cavity; and a cannula subassembly mounted on the insertion sharp such that an end of the cannula subassembly is adjacent a first end of the sharp holder.
2. 2 . The cartridge of claim 1 , wherein the cartridge further comprises a barrier member which, together with the container, encloses the housing.
3. 3 . The cartridge of claim 1 , wherein the cartridge further comprises a set of mating pins for mating to the reusable inserter assembly.
4. 4 . The cartridge of claim 3 , wherein the mating pins are configured to be received in retention shoes of the reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly.
5. 5 . The cartridge of claim 1 , wherein the sharp holder includes a terminal flange which extends out of the housing.
6. 6 . The cartridge of claim 5 , wherein the terminal flange has an obround cross-sectional shape.
7. 7 . The cartridge of claim 1 , wherein the bay includes at least one notch and the infusion set base includes at least one tube retainer, each tube retainer of the infusion set base being disposed within one of the notches of the bay.
8. 8 . The cartridge of claim 1 , wherein the cannula subassembly includes a salient arranged to engage a latch of the infusion set base to retain the cannula sub assembly within the infusion set base when the cannula sub assembly is displaced into a receiving void in the infusion set base.
9. 9 . The cartridge of claim 1 , wherein the cannula subassembly includes a notch arranged to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base when the cannula sub assembly is displaced into a receiving void in the infusion set base.
10. 10 . The cartridge of claim 1 , wherein the retainer body is coupled to the housing via a snap fit engagement.
11. 11 . The cartridge of claim 1 , wherein the cantilevered arms are configured for displacement to a splayed apart state to release the infusion set base by ears of the cannula subassembly when the cannula subassembly is displaced toward the infusion set base.
12. 12 . The cartridge of claim 1 , wherein the housing includes an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed.
13. 13 . The cartridge of claim 1 , wherein the housing includes at least one set of stop surfaces.

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 a 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.AA 927) 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 emb