US-20260124362-A1 - INFUSION SET AND INSERTER ASSEMBLY SYSTEMS AND METHODS

US20260124362A1US 20260124362 A1US20260124362 A1US 20260124362A1US-20260124362-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state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.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
Joshua I. Ferris

Assignees

DEKA PRODUCTS LIMITED PARTNERSHIP

Dates

Publication Date: 20260507
Application Date: 20251231

Claims (13)

1 . An inserter assembly comprising: a first unit; a second unit, the first unit displaceable relative to the second unit; an insertion bias member configured to transition to a stressed state when the first unit is pressed against the second unit; a retainer configured engage a first latch maintaining the insertion bias member in the stressed state when the first unit is displaced toward the second unit beyond a first threshold distance; an insertion driver included in the second unit and displaceable from a first position to an extended position; and a release finger included on the first unit, the release finger configured to dislodge the insertion driver from an insertion driver latch releasing the insertion bias member from the stressed state when the first unit is pulled away from the second unit beyond a second threshold distance, the insertion bias member propelling the insertion driver from the first position to the extended position; wherein the insertion driver disengages the first latch when displaced to the extended position.
2 . The inserter assembly of claim 1 , wherein the inserter assembly further comprises at least one retraction bias member.
3 . The inserter assembly of claim 2 , wherein the at least one retraction bias member is configured to transition to a stressed state when the first unit is pressed against the second unit.
4 . The inserter assembly of claim 3 , wherein the at least one retraction bias member is maintained in the stressed state when the retainer is engaged with the first latch.
5 . The inserter assembly of claim 4 , wherein the at least one retraction bias member is released from the stressed state when the first latch is disengaged as the insertion driver is propelled to the extended position and wherein the insertion driver is displaced to the first position as the at least one retraction bias member transitions from the stressed state to a relaxed state.
6 . The inserter assembly of claim 1 , wherein the release finger includes a paddle body having a first side and a second side, the first side being more medial to a longitudinal axis of the inserter assembly.
7 . The inserter assembly of claim 6 , wherein the second unit includes a director wedge projecting into a displacement path followed by the release finger as the first unit is displaced relative to the second unit.
8 . The inserter assembly of claim 7 , wherein the first and second side of the paddle body include sloped portions, one of the sloped portions configured to contact the director wedge and deflect the release finger away from the insertion driver latch as the first unit is pressed toward the second unit and another of the sloped portions configured to contact the director wedge and deflect the release finger into the insertion driver latch as the first unit is pulled away from the second unit.
9 . The inserter assembly of claim 1 , wherein the insertion driver includes a port configured to mate with an insertion sharp holder.
10 . The inserter assembly of claim 1 , wherein the second unit includes a receptacle body coupled thereto, the receptacle body being disposed on an end of the second unit and including at least one retention interface configured to couple with a mating projection of a disposable cartridge.
11 . The inserter assembly of claim 1 , wherein the first latch includes a pair of arms each having a latching ledge, the arms being cantilevered from a main portion of a latch body.
12 . The inserter assembly of claim 1 , wherein the insertion driver latch includes a projection which extends into a notch in a cantilevered arm extending from a main body of the insertion driver.
13 . The inserter assembly of claim 1 , wherein the second threshold distance is measured from a location of the first unit after the first unit has been displaced the first threshold distance.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Division of U.S. patent application Ser. No. 19/296,320, filed Aug. 11, 2025, entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00546.TA010) which is a Continuation of U.S. patent application Ser. No. 17/883,063, filed Aug. 8, 2022, now US 2022/0379019A1, 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 embodiments, the bottom face of the infusion set base may be substantially level with a skin contacting face of the casing prior to application of the inserter assembly to the skin. In some embodiments, the inserter assembly may further comprise a cannula sub assembly through which the insertion sharp extends. In some embodiments, the cannula sub assembly may be separate from the infusion set base when the trigger is in the fir