IP Library › Granted Patent US 12,544,506
Granted Patent B2
US 12,544,506 · App. 19/176,585 · Granted Feb 10, 2026

Infusion set and inserter assembly systems and methods

Inventor: Richard J. Lanigan (Concord, NH)
Assignee: DEKA Products Limited Partnership
A61M5/158A61M5/14248A61M2005/1585A61M2005/1586
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,544,506
App. No.
19/176,585
Granted
Feb 10, 2026
Kind
B2
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state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.

Claims (26)

1 . A cannulated housing for an infusion set comprising:

a continuous monolithic body comprising:

a cannula; and

a septum housing having a septum receptacle defined by a side wall and bottom wall with a raised region, a lumen of the cannula being enclosed by a surface continuous with the raised region, the side wall having at least one septum retainer guide extending the length of the septum receptacle and aligned with an aperture extending through a bottom of the septum housing, the septum housing including a pair of ears each extending outwardly from the side wall.

2 . The cannulated housing of claim 1 , wherein the septum housing includes a salient on the exterior face of the side wall arranged to engage a latch of an infusion set base to retain the cannulated housing within the infusion set base.

3 . The cannulated housing of claim 1 , wherein a top face of a wall of the septum receptacle has slots recessed therein.

4 . The cannulated housing of claim 3 , wherein the slots include two slots which are disposed opposite one another.

5 . The cannulated housing of claim 3 , wherein the slots are configured to accept a set of projection included in a septum retainer so as to leave a bottom segment of each of the slots open and providing a path to an interior volume of the septum receptacle.

6 . The cannulated housing of claim 1 , wherein the raised region of the septum receptacle has a frusto-conic outer wall.

7 . The cannulated housing of claim 1 , wherein the septum housing includes a notch in an exterior face of the side wall configured to engage a latch of an infusion set base to retain the cannulated housing assembly within the infusion set base.

8 . The cannulated housing of claim 1 , wherein monolithic body is formed via straight pull molding.

9 . The cannulated housing of claim 1 , wherein the monolithic body is devoid of undercut features.

10 . The cannulated housing of claim 1 , wherein the monolithic body is polypropylene.

11 . The cannulated housing of claim 1 , wherein the monolithic body is PTFE.

12 . The cannulated housing of claim 1 , wherein the cannula includes a sharp guide encompassed by a substantially flat peripheral edge at an uppermost part of the raised section.

13 . The cannulated housing of claim 1 , wherein a ledge is positioned adjacent the aperture on an exterior face of the bottom wall.

14 . The cannulated housing of claim 1 , wherein a wall of the aperture forms a catch configured to engage a protuberance of a projection of a portion of a septum retainer.

15 . The cannulated housing of claim 1 , wherein the septum retainer guides are recessed into the side wall.

16 . The cannulated housing of claim 1 , wherein a portion of the cannula extends in a direction away from an exterior face of the bottom wall of the septum housing.

17 . The cannulated housing of claim 1 , wherein a portion of the cannula is at least partially surrounded by a recess in the exterior face of the bottom wall of the septum housing.

18 . The cannulated housing of claim 1 , wherein each of the pair of ears are disposed at an end region of the septum housing opposite the bottom wall.

19 . The cannulated housing of claim 1 , wherein each of the pair of ears includes a ramped face at an end thereof which is most proximate the bottom wall.

20 . A cannulated housing for an infusion set comprising:

a continuous monolithic body comprising:

a cannula; and

a septum housing having a septum receptacle defined by a side wall and bottom wall with a raised region, a lumen of the cannula being enclosed by a surface continuous with the raised region, the side wall having at least one septum retainer guide extending the length of the septum receptacle and aligned with an aperture extending through a bottom of the septum housing, the septum housing including a pair of ears each extending outwardly from the side wall, the ears being disposed opposite one another.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2025
From: LANIGAN, RICHARD J., MR.
To: DEKA PRODUCTS LIMITED PARTNERSHIP
Reel/Frame 071021/0517 →
Continuity (5)
Continuation 18784148 · Jul 25, 2024
Continuation 17883063 · Aug 8, 2022
Continuation 16797624 · Feb 21, 2020
Provisional Application 62809248 · Feb 22, 2019
Related Publication 20250235612A1 · Jul 24, 2025
References Cited (217)
US 2512568A · Saffir · 1950 [cited by applicant]
US 3856009A · Winnie · 1974 [cited by applicant]
US 4755173A · Konopka · 1988 [cited by examiner]
US 5176662A · Bartholomew et al. · 1993 [cited by applicant]
US 5257980A · Van Antwerp et al. · 1993 [cited by applicant]
US D363542S · Parris et al. · 1995 [cited by applicant]
US 5522803A · Teissen-Simony · 1996 [cited by applicant]
US 5743891A · Tolkoff et al. · 1998 [cited by applicant]
US D395501S · Erskine et al. · 1998 [cited by applicant]
US D403398S · Guala et al. · 1998 [cited by applicant]
US D405882S · Yale · 1999 [cited by applicant]
US D416086S · Parris et al. · 1999 [cited by applicant]
US 5980506A · Mathiasen · 1999 [cited by applicant]
US D417733S · Howell et al. · 1999 [cited by applicant]
US 6017328A · Fischell et al. · 2000 [cited by applicant]
US 6056718A · Funderburk et al. · 2000 [cited by applicant]
US 6086575A · Mejslov · 2000 [cited by applicant]
US 6123690A · Mejslov · 2000 [cited by applicant]
US 6261272B1 · Gross et al. · 2001 [cited by applicant]
US 6302866B1 · Marggi · 2001 [cited by applicant]
US 6379339B1 · Klitgaard et al. · 2002 [cited by applicant]
US 6461329B1 · Van Antwerp et al. · 2002 [cited by applicant]
US D465845S · Swenson · 2002 [cited by applicant]
US D465846S · Hwang · 2002 [cited by applicant]
US D472630S · Douglas et al. · 2003 [cited by applicant]
US D476418S · Sprieck et al. · 2003 [cited by applicant]
US 6579267B2 · Lynch et al. · 2003 [cited by applicant]
US 6582403B1 · Bierman et al. · 2003 [cited by applicant]
US 6589229B1 · Connelly et al. · 2003 [cited by applicant]
US D484242S · Wilkinson · 2003 [cited by applicant]
US D484976S · Wilkinson · 2004 [cited by applicant]
US 6685674B2 · Douglas et al. · 2004 [cited by applicant]
US 6699218B2 · Flaherty et al. · 2004 [cited by applicant]
US D488230S · Ignotz et al. · 2004 [cited by applicant]
US 6736797B1 · Larsen et al. · 2004 [cited by applicant]
US 6749589B1 · Douglas et al. · 2004 [cited by applicant]
US 6887417B1 · Gawreluk et al. · 2005 [cited by applicant]
US D507833S · Coss · 2005 [cited by applicant]
US 6923791B2 · Douglas · 2005 [cited by applicant]
US 6949084B2 · Marggi et al. · 2005 [cited by applicant]
US 7070580B2 · Nielsen · 2006 [cited by applicant]
US 7083597B2 · Lynch et al. · 2006 [cited by applicant]
US 7214207B2 · Lynch et al. · 2007 [cited by applicant]
US D547859S · Choi · 2007 [cited by applicant]
US D554253S · Kornerup · 2007 [cited by applicant]
US 7303543B1 · Maule et al. · 2007 [cited by applicant]
US 7303544B2 · Bütikofer et al. · 2007 [cited by applicant]
US 7309326B2 · Fangrow, Jr. · 2007 [cited by applicant]
US 7338465B2 · Patton · 2008 [cited by applicant]
US D576267S · Mogensen et al. · 2008 [cited by applicant]
US 7431876B2 · Mejlhede et al. · 2008 [cited by applicant]
US 7481794B2 · Jensen · 2009 [cited by applicant]
US 7494481B2 · Moberg et al. · 2009 [cited by applicant]
US 7520867B2 · Bowman et al. · 2009 [cited by applicant]
US 7524309B2 · McConnell et al. · 2009 [cited by applicant]
US 7569034B2 · Lynch et al. · 2009 [cited by applicant]
US 7594902B2 · Horisberger et al. · 2009 [cited by applicant]
US D604836S · Crawford et al. · 2009 [cited by applicant]
US D604837S · Crawford et al. · 2009 [cited by applicant]
US D604838S · Crawford et al. · 2009 [cited by applicant]
US D604839S · Crawford et al. · 2009 [cited by applicant]
US 7621395B2 · Mogensen et al. · 2009 [cited by applicant]
US D605287S · Crawford et al. · 2009 [cited by applicant]
US D609804S · Uchida et al. · 2010 [cited by applicant]
US D609806S · Uchida et al. · 2010 [cited by applicant]
US 7678079B2 · Shermer et al. · 2010 [cited by applicant]
US 7699808B2 · Marrs et al. · 2010 [cited by applicant]
US D616094S · Boone, III et al. · 2010 [cited by applicant]
US 7766867B2 · Lynch et al. · 2010 [cited by applicant]
US 7766874B2 · Liniger · 2010 [cited by applicant]
US D627459S · Uchida et al. · 2010 [cited by applicant]
US 7850658B2 · Faust et al. · 2010 [cited by applicant]
US 7887737B2 · Mejlhede et al. · 2011 [cited by applicant]
US 7892216B2 · Fangrow, Jr. · 2011 [cited by applicant]
US 7931615B2 · Fangrow, Jr. · 2011 [cited by applicant]
US 7935104B2 · Yodfat et al. · 2011 [cited by applicant]
US 7946984B2 · Brister et al. · 2011 [cited by applicant]
US 7951080B2 · Taub · 2011 [cited by applicant]
US 7951122B2 · Shekalim · 2011 [cited by applicant]
US 7955297B2 · Radmer et al. · 2011 [cited by applicant]
US 7993306B2 · Marrs et al. · 2011 [cited by applicant]
US 8025658B2 · Chong et al. · 2011 [cited by applicant]
US 8062250B2 · Mogensen et al. · 2011 [cited by applicant]
US 8062253B2 · Nielsen et al. · 2011 [cited by applicant]
US 8157773B2 · Tashjian · 2012 [cited by applicant]
US 8172805B2 · Mogensen et al. · 2012 [cited by applicant]
US 8226614B2 · Turner et al. · 2012 [cited by applicant]
US 8292849B2 · Bobroff et al. · 2012 [cited by applicant]
US 8298172B2 · Nielsen et al. · 2012 [cited by applicant]
US 8303549B2 · Mejlhede et al. · 2012 [cited by applicant]
US 8317759B2 · Moberg et al. · 2012 [cited by applicant]
US 8343115B2 · Lynch et al. · 2013 [cited by applicant]
US 8529515B2 · Woehr et al. · 2013 [cited by applicant]
US 8551047B2 · Burns et al. · 2013 [cited by applicant]
US 8571624B2 · Stafford · 2013 [cited by applicant]
US 8579863B2 · Scherr · 2013 [cited by applicant]
US 8628498B2 · Safabash et al. · 2014 [cited by applicant]
US 8641674B2 · Bobroff et al. · 2014 [cited by applicant]
US 8734391B2 · Yodfat et al. · 2014 [cited by applicant]
US D709186S · Boaz et al. · 2014 [cited by applicant]
US 8790311B2 · Gryn · 2014 [cited by applicant]
US D713957S · Woehr et al. · 2014 [cited by applicant]
US D720466S · Edding · 2014 [cited by applicant]
US 8920381B2 · Ejlersen · 2014 [cited by applicant]
US 8945050B2 · Wei · 2015 [cited by applicant]
US 8956330B2 · Fangrow, Jr. · 2015 [cited by applicant]
US 8961469B2 · Sonderegger et al. · 2015 [cited by applicant]
US 9220833B2 · Robert et al. · 2015 [cited by applicant]
US D747456S · Sonderegger et al. · 2016 [cited by applicant]
US D747459S · Sonderegger et al. · 2016 [cited by applicant]
US D747472S · Bradley et al. · 2016 [cited by applicant]
US 9238123B2 · Weadock et al. · 2016 [cited by applicant]
US 9254373B2 · Hørdum · 2016 [cited by applicant]
US 9265881B2 · Montalvo et al. · 2016 [cited by applicant]
US D754842S · Sonderegger et al. · 2016 [cited by applicant]
US D754843S · Sonderegger et al. · 2016 [cited by applicant]
US 9308354B2 · Farrell · 2016 [cited by examiner]
US D756504S · Sonderegger et al. · 2016 [cited by applicant]
US 9327098B2 · Kelvered et al. · 2016 [cited by applicant]
US 9375537B2 · Montalvo et al. · 2016 [cited by applicant]
US 9545477B2 · Chong et al. · 2017 [cited by applicant]
US 9610401B2 · Antonio et al. · 2017 [cited by applicant]
US D790691S · Davis et al. · 2017 [cited by applicant]
US 9675750B2 · Grant et al. · 2017 [cited by applicant]
US 9731069B2 · Bené et al. · 2017 [cited by applicant]
US 9744295B2 · Wyss et al. · 2017 [cited by applicant]
US D801522S · Shalom · 2017 [cited by applicant]
US 9789250B2 · Hwang · 2017 [cited by applicant]
US 9795777B2 · Sonderegger et al. · 2017 [cited by applicant]
US 9872642B2 · Deck · 2018 [cited by applicant]
US D812223S · Evans et al. · 2018 [cited by applicant]
US D817482S · Howell et al. · 2018 [cited by applicant]
US 9968742B2 · Van Antwerp et al. · 2018 [cited by applicant]
US 9987476B2 · Montalvo et al. · 2018 [cited by applicant]
US 10071209B2 · Solomon et al. · 2018 [cited by applicant]
US 10076356B2 · Hadvary et al. · 2018 [cited by applicant]
US 10080582B2 · Hadvary · 2018 [cited by examiner]
US 10130761B2 · Searle et al. · 2018 [cited by applicant]
US D839423S · Großer et al. · 2019 [cited by applicant]
US D842464S · Davis et al. · 2019 [cited by applicant]
US D863546S · Converse et al. · 2019 [cited by applicant]
US D883474S · Tipsmark · 2020 [cited by applicant]
US D884160S · Adams · 2020 [cited by applicant]
US 10646643B2 · Cabiri et al. · 2020 [cited by applicant]
US D893707S · Burkholz et al. · 2020 [cited by applicant]
US D900308S · Burkholz et al. · 2020 [cited by applicant]
US D913487S · Orofino · 2021 [cited by applicant]
US 10933191B2 · Lawrence et al. · 2021 [cited by applicant]
US D961782S · Locke et al. · 2022 [cited by applicant]
US D975845S · Kobayashi et al. · 2023 [cited by applicant]
US D1008452S · Lanigan · 2023 [cited by applicant]
US D1013864S · Lanigan · 2024 [cited by applicant]
US D1043975S · Cox et al. · 2024 [cited by applicant]
US D1043976S · Cannan et al. · 2024 [cited by applicant]
US D1057941S · Cannan et al. · 2025 [cited by applicant]
US D1064312S · Chae · 2025 [cited by applicant]
US D1077238S · Filgate et al. · 2025 [cited by applicant]
US D1090862S · Furtado et al. · 2025 [cited by applicant]
US 20020055711A1 · Lavi et al. · 2002 [cited by applicant]
US 20020072720A1 · Hague et al. · 2002 [cited by applicant]
US 20040116866A1 · Gorman et al. · 2004 [cited by applicant]
US 20050107743A1 · Fangrow, Jr. · 2005 [cited by applicant]
US 20050273076A1 · Beasley et al. · 2005 [cited by applicant]
US 20060247574A1 · Maule et al. · 2006 [cited by applicant]
US 20070088254A1 · DeStefano · 2007 [cited by applicant]
US 20070191773A1 · Wojcik · 2007 [cited by applicant]
US 20080154205A1 · Wojcik · 2008 [cited by applicant]
US 20090012473A1 · Stettler et al. · 2009 [cited by applicant]
US 20090076451A1 · Teisen-Simony et al. · 2009 [cited by applicant]
US 20090198190A1 · Jensen et al. · 2009 [cited by applicant]
US 20090204077A1 · Hasted et al. · 2009 [cited by applicant]
US 20090218243A1 · Gyrn et al. · 2009 [cited by applicant]
US 20090326472A1 · Carter et al. · 2009 [cited by applicant]
US 20100036323A1 · Smith · 2010 [cited by examiner]
US 20100137695A1 · Yodfat et al. · 2010 [cited by applicant]
US 20100160851A1 · Dimalanta et al. · 2010 [cited by applicant]
US 20100198157A1 · Gyrn et al. · 2010 [cited by applicant]
US 20110009703A1 · Smith · 2011 [cited by examiner]
US 20110034883A1 · Gyrn et al. · 2011 [cited by applicant]
US 20110087159A1 · Parihar · 2011 [cited by examiner]
US 20110098652A1 · Hasted et al. · 2011 [cited by applicant]
US 20120046533A1 · Voskanyan et al. · 2012 [cited by applicant]
US 20120265166A1 · Yodfat · 2012 [cited by applicant]
US 20120283646A1 · Kouyoumijian · 2012 [cited by applicant]
US 20130197439A1 · Melvin · 2013 [cited by examiner]
US 20130338594A1 · De Ros et al. · 2013 [cited by applicant]
US 20140039453A1 · Sonderegger · 2014 [cited by applicant]
US 20140074028A1 · Sonderegger et al. · 2014 [cited by applicant]
US 20140155679A1 · Pesach et al. · 2014 [cited by applicant]
US 20140155819A1 · Amirouche et al. · 2014 [cited by applicant]
US 20140296782A1 · Ulrich et al. · 2014 [cited by applicant]
US 20150051583A1 · Horvath et al. · 2015 [cited by applicant]
US 20150238705A1 · Gravesen et al. · 2015 [cited by applicant]
US 20160015303A1 · Bernstein et al. · 2016 [cited by applicant]
US 20170281863A1 · Kamen et al. · 2017 [cited by applicant]
US 20190009019A1 · Shor · 2019 [cited by examiner]
US 20190060562A1 · Olivas et al. · 2019 [cited by applicant]
US 20210268179A1 · Schøndorff et al. · 2021 [cited by applicant]
US 20220125346A1 · Stafford · 2022 [cited by applicant]
US 20220202366A1 · Mitchell et al. · 2022 [cited by applicant]
US 20230062738A1 · Lanigan et al. · 2023 [cited by applicant]
US 20250082271A1 · Oakes · 2025 [cited by applicant]
US 20250107939A1 · Gardner et al. · 2025 [cited by applicant]
CA 225208 · 2023 [cited by applicant]
CA 219028 · 2025 [cited by applicant]
DE 29905072U1 · 1999 [cited by applicant]
IL 71109 · 2023 [cited by applicant]
JP 2014510574A · 2014 [cited by applicant]
JP D202101054 · 2022 [cited by applicant]
WO WO2004020035A1 · 2004 [cited by applicant]
WO WO2012134588A1 · 2012 [cited by applicant]
WO WO2013070715A1 · 2013 [cited by applicant]
MiniMed Mio Advance Infusion Set, announced in YouTube on May 7, 2019 [Online]. [Retrieved on Aug. 2, 2023], Available from the internet URL:https://www.youtube.com/watch?v=2For6SAvxRQ (Year: 2022). [cited by applicant]
Neria Guard Infusion Set, announced in You Tube on May 17, 2022 [Online]. [Retrieved on Aug. 2, 2003], Available from the internet URL:https://www.youtube.com/watch?v=VUoLi-_gcyE (Year: 2023). [cited by applicant]
Autosoft XC Infusion Set. Product Support Page[Online]. Tandemdiabetes.com 2023. [Retrieved on Aug. 2, 2023]. Retrieved from the Internet: URL:https://support.tandemdiabetes.com/hc/en-us/articles/360039015054/ (Year: 20… [cited by applicant]
Tapecon. using Adhesive Constructions to Improve Chain of Custody Sleep Apnea Tests. No Publication Date. Retrieved Feb. 19, 2025. https://www.tapecon.com/blog/adhesive-constructions-chain-of-custody-sleep-apnea-tests. [cited by applicant]
Medical Design & Outsourcing. new 3M Durapore Advanced Surgical Tape Offers Adhesive Innovation. Oct. 25, 2018. https://www.medicaldesignandoutsourcing.com/new-3m-durapore-advanced-surgical-tape-offers-adhesive-innovati… [cited by applicant]