US-20260124358-A1 - INFUSION SET AND INSERTER ASSEMBLY SYSTEMS AND METHODS

US20260124358A1US 20260124358 A1US20260124358 A1US 20260124358A1US-20260124358-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state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.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 (20)

1 . A cannula sub assembly for an infusion set comprising: a septum housing having a wall defining a septum receptacle, the septum housing having a set of inserter retraction stroke release projections extending outwardly from the wall; a cannula projecting from the septum housing and having a tip at a downstream end and an opposing upstream end disposed in the septum receptacle, the cannula having a lumen extending along a long axis of the cannula; a septum disposed within the septum receptacle and including a septum recess surrounding the second end of the cannula; and a septum retainer including a body having latch arms extending through the septum housing and each including a latching surface which in an engaged state catches a cooperating feature of the septum housing to capture the septum within the septum housing.
2 . The cannula sub assembly of claim 1 , wherein the septum housing includes a salient arranged to engage a latch of an infusion set base to retain the cannula sub assembly within the infusion set base.
3 . The cannula sub assembly of claim 1 , wherein a top face of a wall of the septum receptacle has slots recessed therein.
4 . The cannula sub assembly of claim 3 , wherein the slots include two slots which are disposed opposite one another.
5 . The cannula sub assembly of claim 1 , wherein the septum retainer further comprises a set of projections.
6 . The cannula sub assembly of claim 5 , wherein the set of projections are sized to be received within slots recessed into a top face of a wall defining the septum receptacle.
7 . The cannula sub assembly of claim 6 , wherein the set of projections obstructs only a top portion of the slot when received therein so as to leave a bottom segment of the slot open and exposing a side wall of the septum at a location even with at least a portion of the septum recess.
8 . The cannula sub assembly of claim 1 , wherein the septum receptacle further comprises a raised section in a bottom wall of the septum receptacle, the raised section having a frusto-conic outer wall.
9 . The cannula sub assembly of claim 1 , wherein the septum housing includes a notch in a side wall thereof configured to engage a latch of an infusion set base to retain the cannula sub assembly within the infusion set base.
10 . The cannula sub assembly of claim 1 , wherein the septum housing is formed via straight pull molding.
11 . The cannula sub assembly of claim 1 , wherein the septum housing is devoid of undercut features.
12 . The cannula sub assembly of claim 1 , wherein the septum housing is constructed of one of a list consisting of polypropylene and PTFE.
13 . The cannula sub assembly of claim 1 , wherein the wall of the septum housing includes at least one septum retainer latch arm guide extending the length of the septum receptacle and aligned with an aperture extending through a bottom of the septum housing.
14 . The cannula sub assembly of claim 1 , wherein the body of the septum retainer includes a channel extending therethrough and sized to receive a nub on a face of the septum.
15 . The cannula sub assembly of claim 1 , wherein the septum receptacle includes a raised region at a bottom thereof, the lumen of the cannula being continuous with a sharp guide included in raised region, the sharp guide encompassed by a substantially flat peripheral edge at an uppermost part of the raised section.
16 . The cannula sub assembly of claim 1 , wherein the cannula and septum housing are formed as a single monolithic body.
17 . The cannula sub assembly of claim 1 , wherein the septum recess further defines a fluid receiving volume, the fluid receiving volume disposed upstream of the upstream end of the cannula and in fluid communication with the lumen of the cannula.
18 . The cannula sub assembly of claim 1 , wherein the wall includes a least one fenestration extending therethrough, a portion a sidewall of the septum being exposed through the fenestration.
19 . A cannula sub assembly for an infusion set comprising: a septum housing having a wall defining a septum receptacle, the septum housing having a set of diametrically opposed ears extending outwardly from the wall; a cannula projecting from the septum housing and having a tip at a downstream end and an opposing upstream end disposed in the septum receptacle, the cannula having a lumen extending along a long axis of the cannula; a septum disposed within the septum receptacle and including a septum recess surrounding the second end of the cannula; and a septum retainer including a body having latch arms extending through the septum housing and each including a latching surface which in an engaged state catches a cooperating feature of the septum housing to capture the septum within the septum housing and wherein each of the set of ears includes an ramped face such that each ear projects a first distance at an a first end of each ear most proximate the cannula and a second distance greater than the first distance at a second end of each ear most distal the cannula.
20 . A cannula sub assembly for an infusion set comprising: a septum housing having a wall defining a septum receptacle, the septum housing having a set of ears extending outwardly from the wall; a cannula projecting from the septum housing and having a tip at a downstream end and an opposing upstream end disposed in the septum receptacle, the cannula having a lumen extending along a long axis of the cannula; a septum disposed within the septum receptacle and including a septum recess surrounding the second end of the cannula; and a septum retainer including a body having latch arms extending through the septum housing and each including a latching surface which in an engaged state catches a cooperating feature of the septum housing to capture the septum within the septum housing, the latch arms being disposed at least partially within respective latch arm guides recessed into the septum receptacle, each latch arm being extending along a plane coincident with a midplane of a respective ear of the set of ears.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Continuation of U.S. patent application Ser. No. 19/402,323, filed Nov. 26, 2025, entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00573.TA040) which is a Continuation of U.S. patent application Ser. No. 19/176,585, filed Apr. 11, 2025, now US2025-0235612, published Jul. 24, 2025, and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00495.AB761) which is a Continuation of U.S. patent application Ser. No. 18/784,148, filed on Jul. 25, 2024, now U.S. Pat. No. 12,324,899, Issued Jun. 10, 2025, and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. 00101.00428.AB549) which is a Continuation of U.S. Ser. No. 17/883,063, filed on Aug. 8, 2022, now US2022-0379019, 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 fo