US-20260124359-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state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.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
• Joshua I. Ferris

Assignees

• DEKA PRODUCTS LIMITED PARTNERSHIP

Dates

Publication Date

20260507

Application Date

20251231

Claims (20)

1. 1 - 13 . (canceled)
2. 14 . An inserter system comprising: an inserter assembly comprising; a receptacle including a least one retention interface and an aperture therethrough; an insertion driver being displaceable through the aperture and between a stowed position and an extended position; and at least one spring biased lock member displaceable from a withdrawn position to an extended position; and a disposable cartridge comprising at least one mating projection, a medical device, and at least one set of stop surfaces, each of the at least one mating projection configured to rotate into engagement with a respective one of the at least one retention interface, the at least one set of stop surfaces configured to flank the at least one lock member when the lock member is in the extended position inhibiting rotation of the disposable cartridge.
3. 15 . The system of claim 14 , wherein the at least one lock member is a resiliently cantilevered member.
4. 16 . The system of claim 14 , wherein the medical device is an infusion set.
5. 17 . The system of claim 16 , wherein the infusion set includes an infusion set base and a cannula sub assembly, the cannula subassembly being separate from the infusion set base.
6. 18 . The system of claim 14 , wherein the medical device is a lancet.
7. 19 . The system of claim 14 , wherein the medical device is an analyte sensor.
8. 20 . The system of claim 14 , wherein each of the at least one mating projection is a mating pin having a head portion with a cross sectional area greater than a stem portion which couples the head portion to the cartridge.
9. 21 . The system of claim 14 , wherein the at least one retention interface is a retention shoe.
10. 22 . The system of claim 14 , wherein each of the at least one retention interface is configured to prevent translational displacement of a respective one of the at least one mating projection along an axis of the inserter assembly when the respective mating projection is in engagement with that retention interface.
11. 23 . The system of claim 14 , wherein the cartridge is configured to displace the at least one lock member to the withdrawn position when the at least one mating projection is out of engagement with the at least one retention interface and the cartridge is against the receptacle.
12. 24 . The system of claim 14 , wherein the cartridge comprises: an interior housing including tabs disposed on cantilevered portions of the interior housing; and an exterior housing including receiving slots for the tabs, the interior housing coupled to the exterior housing when the tabs are disposed at least partially within the receiving slots.
13. 25 . The system of claim 24 , wherein the receptacle includes deflector members.
14. 26 . The system of claim 25 , wherein the deflector members are configured to deflect the cantilevered portions of the interior housing when the mating projections are in engagement with the retention interfaces, the exterior housing being uncoupled from the interior housing when the cantilevered portions of the interior housing are in a deflected state.
15. 27 . The system of claim 24 , wherein the at least one set of stop surfaces is defined by edge walls on either side of at least one of the cantilevered portions.
16. 28 . The system of claim 14 , wherein the insertion driver includes a port.
17. 29 . The system of claim 28 , wherein the cartridge includes a sharp holder coupled to an insertion sharp, the sharp holder configured to couple into the port when each of the at least one mating projection is in engagement with a respective one of the at least one retention interface.
18. 30 . The system of claim 28 , wherein the cartridge includes a sharp holder with a terminal flange having a shape which may be displaced into the port when the cartridge is in a first orientation on the receptacle and may not be displaced out of the port when the cartridge is in a position in which each of the at least one mating projection is in engagement with a respective one of the at least one retention interface.
19. 31 . The system of claim 14 , wherein the cartridge includes a sharp holder coupled to a sharp.
20. 32 . The system of claim 14 , wherein the cartridge includes at least one guide, at least a portion of the medical device configured to displace along the guide when the insertion driver is displaced from the stowed position to the extended position.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Continuation 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