Infusion pumps
Contents
1. 808 7 7 34 800 in FIG 12 804 E R We 7 100 200 600 22 EEN lt 7 pS SS S NA V IN NEES qu is ted ip 2 pe 500 ASSESS ccs OO 612 U S Patent Dec 9 2014 Sheet 9 of 12 US 8 905 972 B2 7 CSS SS 812 H 100 250 20 TiS pS SS EN pc 3 116 A YN 22 j Pa ES SSS RR 612 196 FIG 13 U S Patent Dec 9 2014 Sheet 10 of 12 US 8 905 972 B2 200 106 250 T T SPEISSI 4 Nit MN 7 2 M 7 ie 4 55 5 535 55 U S Patent Dec 9 2014 Sheet 11 of 12 US 8 905 972 B2 200 216 264 260 266 222 202 FIG 16 262 U S Patent Dec 9 2014 Sheet 12 of 12 US 8 905 972 B2 US 8 905 972 B2 1 INFUSION PUMPS CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit of U S Provisional Application Ser No 61 415 830 filed Nov 20 2010 and entitled Infusion Pumps which is incorporated herein by reference in its entirety This application claims the benefit of U S Provisional Application Ser No 61 487 705 filed May 18 2011 and entitled Infusion Pumps which is incorporated herein by reference in its entirety BACKGROUND 1 Field The present devices and methods relate generally to ambu latory infusion pumps 2 Des2. In some instances the cartridge 100 may be detached from a baseplate assembly and inserted into the pump assembly 200 prior to the baseplate assembly being secured to the pump assembly In other instances the cartridge 100 may be secured to integral with or otherwise a part of a baseplate assembly so that the cartridge will be inserted into the pump assembly 200 as the baseplate assembly is secured to the pump assembly For example the baseplate assembly 300 includes a cartridge 100 that is secured to the baseplate 500 e g with adhesive in exemplary system 10 while the car tridge 100 and baseplate assembly 301 are separate structures in exemplary system 11 Baseplate 502 is employed in those instances where the cartridge and baseplate are detached from one another It should also be noted here that in addition to the base plate cartridge and energy supply some baseplate assem blies may also include the cannula 600 as well as an inserter 800 for inserting the cannula Other baseplate assemblies with various combinations of these components e g a base plate and a cartridge that is either secured to the baseplate or separated therefrom may also be provided The baseplate assembly components may be integrated together into a single package that can be delivered to the user as shown for instance as baseplate assembly 300 in FIG 17 In other implementations some or all of the baseplate assembly com ponents may be provided to t
3. 5 505 709 A 4 1996 Funderburk et al 5 531 697 A 7 1996 Olsen et al 5 586 868 A 12 1996 Lawless 5 665 065 A 9 1997 Colman et al 5 695 473 A 12 1997 Olsen 5 816 779 A 10 1998 Lawless 5 858 001 A 1 1999 Tsals et al Continued FOREIGN PATENT DOCUMENTS WO WO 0170307 Al 9 2001 WO WO 0220073 A2 3 2002 Continued OTHER PUBLICATIONS Gnanalingham et al Accuracy and reproducibility of low dose insulin administration using pen injectors and syringes Arch Dis Child 1998 79 59 62 Continued Primary Examiner Jason Flick 74 Attorney Agent or Firm Henricks Slavin amp Holmes LLP 57 ABSTRACT Ambulatory infusion pumps pump assemblies and baseplate assemblies including cartridges baseplates cannulas insert ers and related components and batteries therefor as well as component combinations and related methods 15 Claims 12 Drawing Sheets 200 US 8 905 972 B2 Page 2 56 References Cited 2003 0161744 Al 8 2003 Vilks et al 2003 0163088 Al 8 2003 Blomquist U S PATENT DOCUMENTS 2003 0163090 Al 8 2003 Blomquist et al 2003 0163223 Al 8 2003 Blomquist 5 935 106 A 8 1999 Olsen 2003 0167036 Al 9 2003 Flaherty 5 954 696 9 1999 Ryan 2003 0167039 A1 9 2003 Moberg 5 084 894 A 11 1999 Poulsen 2003 0199085 Al 10 2003 Berger et al 6 033 377 A 3 2000 Rasmussen 2003 0199824 A1 10 2003 Mahoney et al 6 248 093 Bl 6 2001 Moberg 2003 0199825 Al 10 2003 Flaherty 6 296 907 B1 10 2001 Viksn
4. 12 United States Patent Smith et al US008905972B2 US 8 905 972 B2 Dec 9 2014 10 Patent No 45 Date of Patent 54 75 73 21 22 65 60 51 52 58 56 INFUSION PUMPS Inventors Roger E Smith Ivins UT US Carla Mann Woods Beverly Hills CA US Assignee perQflo LLC Valencia CA US Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 U S C 154 b by 134 days Appl No 13 300 574 Filed Nov 19 2011 Prior Publication Data US 2012 0184907 A1 Jul 19 2012 Related U S Application Data Provisional application No 61 415 830 filed on Nov 20 2010 provisional application No 61 487 705 filed on May 18 2011 Int Cl A61M 1 00 2006 01 A61M 5 142 2006 01 A61M 5 168 2006 01 U S CI CPC A61M 5 14244 2013 01 A61M 5 14248 2013 01 461M 2005 16863 2013 01 461M 2205 8256 2013 01 461M 2005 14268 2013 01 determina 604 152 Field of Classification Search USPC travestis dieere 604 152 See application file for complete search history References Cited U S PATENT DOCUMENTS 3 701 345 A 10 1972 Heilman 4 116 240 A 9 1978 Guiney 4 206 764 A 6 1980 Williams 4 529 401 A 7 1985 Leslie et al 4 731 058 A 3 1988 Doan 4 985 015 A 1 1991 Obermann 5 244 461 A 9 1993 Derlien 5 281 111 A 1 1994 Plambeck et al 5 378 126 1 1995 Abrahamson et al 5 380 314 A 1 1995 Herweck et al
5. 14 An infusion pump system as claimed in claim 11 further comprising a fluid cartridge that includes a fluid reservoir and is con figured to fit within the fluid cartridge receiving area 15 An infusion pump system as claimed in claim 11 wherein the infusion pump assembly includes a pump module
6. 6 830 558 B2 12 2004 Flaherty et al 2005 0148938 Al 7 2005 Blomquist 6 852 104 B2 2 2005 Blomquist 2005 0182366 Al 8 2005 Vogt et al 6 902 207 B2 6 2005 Lickliter 2005 0197626 Al 9 2005 Moberg et al 6 939 324 B2 9 2005 Gonnelli et al 2005 0215982 Al 9 2005 Malave et al 7 029 455 B2 4 2006 Flaherty 2005 0222645 Al 10 2005 Malave et al 7 033 338 B2 4 2006 Vilks et al 2005 0234404 Al 10 2005 Vilks et al 7 063 684 B2 6 2006 Moberg 2005 0238507 Al 10 2005 Dilanni et al 7 137 964 B2 11 2006 Flaherty 2006 0074381 Al 4 2006 Malave et al 7 179 226 B2 2 2007 Crothall et al 2006 0178633 Al 8 2006 Garibotto et al 7 193 521 B2 3 2007 Moberg et al 2006 0184154 Al 8 2006 Moberg et al 7 214 207 B2 5 2007 Lynch et al 2006 0189939 AI 8 2006 Gonnelli et al 7 250 037 2 7 2007 Shermer et al 2006 0200112 Al 9 2006 Paul 7 303 543 B1 12 2007 Maule et al 2006 0206054 Al 9 2006 Shekalim 7 306 578 B2 12 2007 Gray et al 2006 0282290 Al 12 2006 Flaherty et al 7 311 693 B2 12 2007 Shekalim 2007 0021733 Al 1 2007 Hansen et al 7 390 314 B2 6 2008 Stutz Jr et al 2007 0049870 Al 3 2007 Gray et al 7 455 663 B2 11 2008 Bikovsky 2007 0073228 Al 3 2007 Mernoe et al 7 481 792 B2 1 2009 Gonnelli et al 2007 0073235 Al 3 2007 Estes et al 7 510 544 B2 3 2009 Vilks et al 2007 0073236 Al 3 2007 Mernoe et al 7 584226 B2 5 2009 Mernoe et al 2007 0100283 A1 5 2007 Causey et al 7 569 050 B2 8 2009 Moberg et al 2007 0118405 Al 5 2007 Campbell et al 7 621 893 B2 11 2
7. 9 is a front view showing a patient s skin being cleaned FIG 10 is a section view showing the pump assembly attached to the exemplary baseplate assembly including car tridge a cannula inserter and cannula plus a pull before use plug FIG 11 is a section view showing the system illustrated in FIG 10 on the cleaned skin prior to cannula insertion FIG 12 is a section view showing the system illustrated in FIG 11 after cannula insertion FIG 13 is a section view showing the system illustrated in FIG 12 on the skin with the cannula inserted and the inserter being removed FIG 14 is a section view showing the system illustrated in FIG 13 dispensing medicament by way of the cannula FIG 15 is a side view of a portion of one of the baseplate assemblies illustrated in FIG 1 FIG 16 is a bottom view ofa portion of the pump assembly illustrated in FIG 1 FIG 17 is an exploded perspective view of another exem plary infusion pump system DETAILED DESCRIPTION The following is a detailed description of the best presently known modes of carrying out the inventions This description US 8 905 972 B2 3 is not to be taken limiting sense but is made merely for the purpose of illustrating the general principles of the inven tions It should also be noted here that the specification describes structures and methods mainly in the context of cartridge based infusion pumps which are especially well suited for the sub
8. and or provides more opera tional flexibility than conventional infusion pumps SUMMARY A system in accordance with at least one of the present inventions includes an infusion pump assembly and a base plate assembly The infusion pump assembly may include a housing and a rechargeable battery in the housing The base plate assembly may include a baseplate and a baseplate energy supply and may be configured to be attached to the infusion pump housing Energy from the baseplate power supply may be transferred to the rechargeable battery when the baseplate assembly is attached to the housing A method in accordance with at least one of the present inventions includes the step of securing a baseplate assembly with a baseplate energy supply to an infusion pump assembly with a rechargeable battery such that energy from the base plate energy supply is transferred to the rechargeable battery An infusion pump system in accordance with at least one of the present inventions includes an infusion pump assembly with a plunger pusher and a baseplate assembly with a base plate and a medicament cartridge including a barrel defining 20 25 30 35 40 45 50 55 60 65 2 a reservoir and a plunger movable within the barrel on the baseplate The infusion pump assembly and the baseplate assembly may be configured to be attached to one another in such a manner that the plunger pusher will be aligned with the plunger A baseplat
9. baseplate assembly 300 shown in FIG 17 containing cartridge 100 energy supply 400 baseplate 500 cannula 600 not shown and inserter 800 and the remote control 1000 if not already at hand Step S105 The pump assembly 200 and baseplate assembly 300 may then be removed from the skin separated and the baseplate assembly 300 discarded Steps S106 and S107 Next the cover if present may be removed from energy supply 400 Step S108 and the new baseplate assembly 300 may then be attached to the pump assembly 200 Step S109 The plug 110 may remain in the cartridge through bore 116 for a pusher zeroing procedure described in detail in U S patent application Ser No 12 890 207 Step S110 The zero US 8 905 972 B2 15 ing procedure may be user initiated or may be an automatic aspect of pump operation If the results of the zeroing proce dure are negative the pusher is withdrawn from the cartridge the baseplate assembly 300 or at least medicament cartridge 100 is removed and discarded a new baseplate assembly or cartridge is inserted and the zeroing procedure is repeated Steps S111 112 S113 and 114 Alternatively if the results of the zeroing procedure are positive the pusher is withdrawn and the plug 110 may be removed FIG 10 Step 115 The user may clean the skin surface S onto which the baseplate 500 of baseplate assembly 300 will be adhered and liner 544 may be removed to expose a baseplate adhesive
10. example the width of the opening 226 may be about 60 to 90 of the diameter and is about 83 in the illustrated implementation In other 5 20 40 45 8 implementations the cartridge opening 226 may be elimi nated and replaced by a protrusion that covers the cartridge and is part of the housing top wall 216 A plurality of electrical contacts 228 230 and 232 may extend through or be carried on the housing bottom portion 208 as is illustrated in FIG 4 As discussed in greater detail below two of the contacts e g contacts 228 and 230 may be used to electrically connect the pump assembly 200 to a battery recharger e g charger 700 in FIG 6 and all of the contacts at least in some implementations may be used by the pump assembly during a baseplate identification proce dure described below With respect to dimensions some embodiments of the exemplary housing 202 may have the following dimensions length dimensions of 42 mm 1 0 42 mm 0 10 40 1 0 mm 40 0 10 mm or 40 5 0 mm width dimensions of 34 mm 1 0 34 mm 0 10 mm 32 mm 1 0 mm 32 mm 0 10 mm or 32 mm 5 mm overall thickness or height dimensions of 9 mm 1 0 mm 9 mm 0 10 mm and wall thickness dimensions on the order of 1 0 mm 0 10 mm Suitable housing materials include but are not limited to plastic or other materials having a modulus of elasticity of 0 2 1 0 million psi As mentioned above pressure sensors may be provi
11. in such a manner that the baseplate can be separated from the infusion pump assembly without removing the pump module from the infusion pump assembly 2 An infusion pump system as claimed in claim 1 wherein the infusion pump housing includes a recess configured to receive the baseplate battery the baseplate battery projects outwardly from the base plate and the infusion pump housing recess and baseplate battery are respectively positioned such that the baseplate battery will be located at least partially within the pump housing recess when the infusion pump assembly and the base plate assembly are attached to one another 3 An infusion pump system as claimed in claim 1 wherein the baseplate battery includes energy supply electrical con tacts the infusion pump assembly includes pump assembly elec trical contacts and the baseplate energy supply electrical contacts and pump assembly electrical contacts are respectively positioned such that the baseplate battery electrical contacts will contact the pump assembly electrical contacts when the infusion pump assembly and the baseplate assembly are attached to one another 4 An infusion pump system as claimed in claim 1 wherein therechargeable battery has a rechargeable battery voltage the baseplate battery has a baseplate battery voltage and the infusion pump assembly includes a DC to DC con verter adapted to convert the baseplate battery voltage to a voltage that is greater than the re
12. present inventions may incorporate any one combinations of less than all or all of the methodologies or devices referenced above Although the inventions disclosed herein have been described in terms of the preferred embodiments above numerous modifications and or additions to the above de scribed preferred embodiments would be readily apparent to one skilled in the art It is intended that the scope of the present inventions extends to all such modifications and or additions and that the scope of the present inventions is lim ited solely by the claims set forth below or later added Finally with respect to terminology that may be used herein whether in the description or the claims the following should be noted The terms comprising including car gt gt lt lt rying having containing involving and the like are open ended and mean including but not limited to Ordinal terms such as first second third do not and of themselves connote any priority precedence or order of one element over another or temporal order in which steps of a method are performed Instead such terms are merely labels to distinguish one element having a certain name from another element having a same name but for the ordinal US 8 905 972 B2 17 term to distinguish the elements And or means that the listed items are alternatives but the alternatives also include any combin
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14. 009 Moberg et al 2007 0123819 AI 5 2007 Mernoe et al 7 632 247 B2 12 2009 Adams 2007 0149861 Al 6 2007 Crothall et al 7 641 608 B2 1 2010 Daoud et al 2007 0149926 Al 6 2007 Moberg et al 7 641 649 B2 1 2010 Moberg et al 2007 0156092 A1 7 2007 Estes et al 7 713 258 B2 5 2010 Adams et al 2007 0167905 Al 7 2007 Estes et al 7713262 B2 5 2010 Adams et al 2007 0167912 Al 7 2007 Causey et al 7794 434 B2 9 2010 Mounce et al 2007 0173762 7 2007 Estes et al 7 806 868 B2 10 2010 De Polo et al 2007 0179444 Al 8 2007 Causey et al 8 430 849 B2 4 2013 Smith et al 2007 0219480 Al 9 2007 Kamen et al 8 568 361 B2 10 2013 Yodfat etal 604 155 2007 0228071 Al 10 2007 Kamen et al 8 777 901 B2 7 2014 Smith et al 2007 0276329 Al 11 2007 Mernoe 2001 0034502 Al 10 2001 Moberg et al 2007 0282269 Al 12 2007 Carter et al 2001 0041869 Al 11 2001 Causey et al 2007 0287960 Al 12 2007 Adams et al 2001 0053887 Al 12 2001 Douglas et al 2007 0299397 Al 12 2007 Alferness et al 2002 0040208 Al 4 2002 Flaherty et al 2007 0299398 Al 12 2007 Alferness et al 2002 0077598 Al 6 2002 Yap et al 2007 0299399 A1 12 2007 Alferness et al 2002 0091358 Al 7 2002 Klitmose 2007 0299400 A1 12 2007 Alferness et al 2002 0123740 Al 9 2002 Flaherty et al 2007 0299401 Al 12 2007 Alferness et al 2002 0151855 A1 10 2002 Douglas et al 2007 0299405 A1 12 2007 Kaufmann et al 2002 0173748 Al 11 2002 McConnell et al 2007 0299408 Al 12 2007 Alferness et al
15. 02 has a top portion 206 and a bottom portion 208 The top portion 206 which includes two side walls 210 two end walls 212 a top wall 214 and rounded corners therebetween generally defines the internal volume in which the pump module and other pump assembly components are carried as well as the overall vol ume of the pump assembly 200 The bottom portion 208 includes a bottom wall 216 which functions as a cover for most of the internal volume The outer surface of the top wall 214 defines the top face or top surface of the housing 202 and the outer surface of the bottom wall 216 defines the bottom face or bottom surface of the housing There is a cartridge insertion opening 218 in the bottom wall 216 through which the cartridge 100 is inserted into the cartridge receiving area 220 when baseplate assembly 300 is attached to pump assembly 200 Bottom wall 216 also includes a baseplate energy supply receiving area or 5 222 into which the energy supply 400 projects when a baseplate assembly e g baseplate assembly 300 is attached to pump assembly 200 This arrangement facilitates the transfer of energy from the baseplate energy supply 400 to the rechargeable battery 238 as described below The top wall 214 of the housing 202 may be provided with one or more openings For example an inserter opening 224 may be provided in the housing top wall 214 to enable access for an inserter 800 or 800 Such acc
16. 108 Remove cover from primary battery S109 Attach new baseplate assy to pump assy S110 Zeroing Yes OK S112 Rewind pusher 5113 Remove and discard old baseplate assy cartridge 5114 Obtain new cartridge baseplate assy FIG 8 S115 Remove plug S116 Prepare skin S117 Expose baseplate adhesive S118 Grasp inserter press against skin S119 Press inserter trigger 5120 Disengage inserter Improper cannula insertion detected Yes No 122 Start infusion S123 US 8 905 972 B2 Sheet 6 of 12 Dec 9 2014 U S Patent 202 gt aN Ls 200 A etre ANB NW 4 2 Lam an AY Xi Drm 77 wae N ChE MANS YAO a 4 _ 7 S 8 PASS EAS E N 4 WSS 222 EZ 595 U S Patent Dec 9 2014 Sheet 7 of 12 US 8 905 972 B2 lt lt AZ S 2 LES YA 4 800 ar i Bi 600 72174 7 m 7 200 ae HY NS Z2 224 AA SOUS SEU NE 2 SS AN E 500 RYN 75 SST 2 106 FIG 11 U S Patent Dec 9 2014 Sheet 8 of 12 US 8 905 972 B2
17. 12 0022452 Al 1 2012 Welsch et al 604 151 8 Wily 5 2012 0078170 Al 3 2012 Smith et al practice Diabetes Metabolism Research and Reviews Abstract 2012 0078181 Al 3 2012 Smith et al Nov 2006 vol 23 Is 4 265 268 2012 0078182 Al 3 2012 Smith et al Knee et al A novel use of U 500 insulin for continuous subcutane 2012 0078183 Al 3 2012 Smith et al ous insulin infusion in patients with insulin resistance Endocrine 2012 0078184 Al 3 2012 Smith et al Practice vol 9 No 3 May 2003 2012 0078185 Al 3 2012 Smith et al Medtronic The MiniMed Paradigm Real Time Insulin Pump and 2012 0078216 Al 3 2012 Smith et al Continuous Glucose Monitor System Insulin Pump UserGuide 2012 0078217 Al 3 2012 Smith et al 2008 2012 0078222 Al 3 2012 Smith et al 2012 0184907 Al 7 2012 Smith et al cited by examiner U S Patent Dec 9 2014 Sheet 1 of 12 US 8 905 972 B2 U S Patent Dec 9 2014 Sheet 2 of 12 US 8 905 972 B2 FIG 2B U S Patent Dec 9 2014 Sheet 3 of 12 US 8 905 972 B2 U S Patent Dec 9 2014 Sheet 4 of 12 US 8 905 972 B2 Time U S Patent Dec 9 2014 Cartridge is empty Sheet 5 of 12 US 8 905 972 B2 S103 Use remote to signal baseplate assy change Rewind pusher Obtain remote S106 Remove system from skin S101 Replace baseplate assy msg 102 5104 Obtain new baseplate assy S105 S107 Remove and discard old baseplate assembly S
18. 2002 0173769 A1 11 2002 Gray et al 2008 0021395 Al 1 2008 4 et al 2002 0183616 Al 12 2002 Toews et al 2008 0027296 Al 1 2008 Hadvary et al 2003 0040700 Al 2 2003 Hickle et al 2008 0045902 Al 2 2008 Estes et al 2003 0055380 AI 3 2003 Flaherty 2008 0045903 Al 2 2008 Estes et al 2003 0073952 Al 4 2003 Flaherty et al 2008 0045904 AI 2 2008 Estes et al 2003 0100863 Al 5 2003 Shekalim 2008 0045931 Al 2 2008 Estes et al 2003 0125672 Al 7 2003 Adair et al 2008 0058718 Al 3 2008 Adams et al 2003 0135159 AI 7 2003 Daily et al 2008 0097318 Al 4 2008 Adams US 8 905 972 B2 Page 3 56 References Cited FOREIGN PATENT DOCUMENTS U S PATENT DOCUMENTS WO WO 0228455 Al 4 2002 WO WO 0249509 A2 6 2002 2008 0097324 Al 4 2008 Adams et al WO WO 2004098390 A2 11 2004 2008 0097381 Al 4 2008 Moberg et al WO WO 2005018703 A2 3 2005 2008 0119790 AI 5 2008 Hawkins et al WO WO 2005018705 A2 3 2005 2008 0132842 AI 6 2008 Flaherty WO WO 2005037350 A2 4 2005 2008 0167620 Al 7 2008 Adams et al WO WO 2005046756 A2 5 2005 2008 0215006 AI 9 2008 Thorkild WO WO 2005072794 A2 8 2005 2008 0215015 AI 9 2008 Cindrich et al WO WO 2005072795 A2 8 2005 2008 0215035 AI 9 2008 Yodfat et al WO WO 2006032689 Al 3 2006 2008 0234630 Al 9 2008 Iddan et al WO WO 2006032692 Al 3 2006 2008 0255516 10 2008 Yodfat et al WO WO 2006061354 Al 6 2006 2008 0281270 Al 11 2008 Cross et al WO WO 2006104806 A2 10 2006 2008 0312512 Al 12 2008 Brukalo et al WO WO 2006108809 Al 1
19. 2009088956 A2 7 2009 2009 0163865 Al 6 2009 Hines et al WO WO 2009097292 A2 8 2009 2009 0163866 Al 6 2009 Hines et al WO WO 2009113075 A1 9 2009 2009 0182277 Al 7 2009 Carter WO WO 2009116045 Al 9 2009 2009 0192471 Al 7 2009 Carter et al WO WO 2009125398 A2 10 2009 2009 0198186 Al 8 2009 Mernoe et al WO WO 2009133557 A2 11 2009 2009 0198215 Al 8 2009 Chong et al WO WO 2009146080 A2 12 2009 2009 0221971 Al 9 2009 Mejlhede et al WO WO 2009158651 A2 12 2009 2009 0240240 AI 9 2009 Hines et al WO WO 2010022069 A2 2 2010 2009 0254037 Al 10 2009 Bryant Jr et al WO WO 2010026580 A2 3 2010 2009 0254041 Al 10 2009 Krag et al WO WO 2010029551 A2 3 2010 2009 0259176 Al 10 2009 Yairi 2009 0326453 Al 12 2009 Adams et al OTHER PUBLICATIONS 2009 0326454 Al 12 2009 Cross et al 2009 0326455 Al 12 2009 Carter Nono Nordisk Canada Inc NovoPen4 User Manual English 2009 0326456 Al 12 2009 Cross et al 2009 2009 0326472 Al 12 2009 Carter et al Kristensen et al Dose accuracy and durability of a durable insulin 2010 0049128 Al 2 2010 McKenzie et al pen before and after simulated lifetime use Current Medical 2010 0069848 i1 lt 20 10 Alfemess ovat Research and Opinion Oct 2011 27 No 10 1877 1883 2010 0137695 Al 6 2010 Yodfat et al Ani C OneTouch Ping O s Booklet Jul 2010 0198060 Al 8 2010 Fago et al mias Corp ne ouch Tug Owner s Booklet Jul 2008 BOSE a Garget al U 500 insulin why when and how to use in clinical 20
20. For example in those instances where the baseplate energy storage device is a button battery the base plate energy supply and the infusion pump energy supply receiving area may be configured such that contacts within the receiving area directly contact the anode and cathode cans of the battery Inductive coupling may be employed in other implementations 25 40 45 50 10 At least some implementations will employ an energy stor age device 404 having a fully charged open circuit voltage of generally about 1 Volt or between about 1 0 1 5 Volts The energy storage device 404 may be a Zinc air battery the advantages of which include high energy density small size and wide availability Zinc air batteries obtain their energy from the electro chemical reaction of oxidizing zinc with oxygen from the air Therefore the housing 402 may be provided with an aperture and a cover that can be used to prevent air from initiating the reaction and activating the battery As such in some embodiments prior to use a cover must be removed from the housing 402 Other primary bat teries e g an alkaline battery that may be used to recharge rechargeable battery 238 may not require removal ofa battery cover Returning to the above example the recharging of rechargeable battery 238 with baseplate energy supply 400 may use a DC to DC converter for instance within circuitry 237 FIG 6 The DC to DC converter may be used to convert the nomina
21. ample allow the user to transmit instructions to the pump assembly or facilitate communica US 8 905 972 B2 5 tion between the pump assembly and the user e g an alarm condition message or other message concerning the condi tions of the pump assembly An exemplary remote control 1000 FIG 14 may be configured to facilitate one some or all of the following operations 1 turning the remote control 1000 on or off 2 associating or the remote control 1000 to the pump assembly 200 3 obtaining status information such as medicament level battery charge level and or alarm conditions 4 silencing the pump assembly alarm 5 selecting options that may be associated with the pump assembly alarm such as type of alarm audible pal pable and or visible and strength volume of alarm 6 con necting the remote control to a computer to for example update remote control or pump assembly firmware load and delete delivery profiles stored in the pump assembly or remote control and otherwise reprogram the pump assembly or remote control 7 selecting medicament options such as medicament concentrations 8 selecting and initiating a stored medicament delivery profile 9 increasing and decreasing medicament dose rate 10 retracting the plunger pusher from the cartridge to the home position and or 11 pausing a dispensing operation A user may pause delivery in order to remove or replace a patient appl
22. articular basal rate a series of time spaced bolus deliveries or some combination thereof thatis equated to motor rotations at particular rates and times required to deliver medicament in accordance with the pro 20 25 30 35 40 45 50 55 60 65 16 file The profile may be input by the user with the remote control 1000 and stored by the pump assembly controller For example the remote control may store a number of different delivery profiles and bolus deliveries from which the patient can choose Such profiles may correspond to for example and depending on the medicament days where vigorous exercise is expected days where it is not incidences of increased pain etc Alternatively or in addition the profile stored in the pump assembly controller may be set by a clinician s programming unit In such a case a remote control may not be needed to initiate e g basal delivery The discussion above is also applicable to use of the pocket pump system 11 Minor variations in the above described procedure include for example use of baseplate assembly 301 with baseplate 501 deploying the infusion set 503 instead of a cannula and priming of the infusion set tube Another exemplary ambulatory infusion system is gener ally represented by reference numeral 10 in FIG 17 The exemplary infusion system 10 is essentially identical to infu sion system 10 and similar elements are represented by simi lar re
23. ate 501 is configured to connect the cartridge 100 to an infusion set 503 so that the system may be deployed as a pocket pump a belt worn pump or some other wearable pump Baseplate 502 is a medicament non delivery baseplate that includes a plug 504 which may be used to seal the cartridge 100 during periods of non use As also described above the system may be provided with baseplate assemblies configured for different types or con centrations of medicament such as different insulin concen trations Additionally or alternatively a variety of baseplate assemblies may be provided with different medicament fill volumes to correspond to the amount of medicament used during the baseplate assembly lifetime Therefore an assort 20 25 30 35 40 45 50 55 60 65 12 ment of baseplate assemblies is possible containing different types concentrations and or amounts of medicament such as various concentrations and or units of insulin These different baseplate assemblies may be distinguished by packaging labeling or other cues such as different colors for the car tridges and or baseplates of the various baseplate assemblies Additionally and as discussed below pump assembly 200 and baseplate assemblies 300 302 may be respectively con figured such that a pump assembly can determine which one of a variety of baseplate assemblies is attached to the pump assembly and then prepare to proceed in accordance wi
24. ation of the listed items The terms approxi mately about substantially and generally allow for a certain amount of variation from any exact dimensions mea surements and arrangements and should be understood within the context of the description and operation of the invention as disclosed herein Terms such as top bottom above and below are terms of convenience that denote the spatial relationships of parts relative to each other rather than to any specific spatial or gravitational orientation Thus the terms are intended to encompass an assembly of compo nent parts regardless of whether the assembly is oriented in the particular orientation shown in the drawings and described in the specification upside down from that orien tation or any other rotational variation therefrom We claim 1 An infusion pump system comprising an infusion pump assembly including a housing a pump module within the housing that drives fluid from a res ervoir within the housing and a rechargeable battery within the housing and a baseplate assembly including a baseplate and a baseplate battery wherein the infusion pump assembly and the baseplate assembly are configured to be attached to one another in such a manner that energy from the baseplate battery is transferred to the rechargeable battery and wherein the infusion pump assembly and the baseplate assembly are configured to be attached to one another
25. chargeable battery voltage 5 An infusion pump system as claimed in claim 1 wherein the baseplate battery comprises a primary cell battery 6 An infusion pump system as claimed in claim 1 further comprising a cartridge that includes the reservoir 20 25 30 35 40 50 55 18 7 Aninfusion pump system as claimed in claim 6 wherein the cartridge is secured to the baseplate 8 An infusion pump system comprising an infusion pump assembly including a housing and a rechargeable battery within the housing a baseplate assembly including a baseplate and a baseplate energy supply a medicament reservoir a temperature sensor positioned to sense a temperature of or approximating that of medicament in the medicament reservoir and a controller configured to modulate recharging of the rechargeable battery as a function of temperature sensed by the temperature sensor wherein the infusion pump assembly and the baseplate assembly are configured to be attached to one another in such a manner that energy from the baseplate energy supply is transferred to the rechargeable battery 9 An infusion pump system as claimed in claim 1 wherein the baseplate assembly includes a cannula and a cannula inserter 10 An infusion pump system comprising an infusion pump assembly including a housing and a rechargeable battery within the housing and a baseplate assembly including a baseplate a baseplate energy supply a medicame
26. cription of the Related Art Ambulatory infusion pumps also referred to herein simply as infusion pumps are relatively small at least substan tially self contained devices that are used to introduce drugs and other infusible substances collectively medicament into patients bodies Some infusion pumps are configured to be worn on a belt or carried in a clothing pocket Other infusion pumps are configured to be adhered to skin in patch like fashion Infusion pumps are advantageous in that they may be used to for example subcutaneously introduce or infuse medicament on an ongoing or even continuous basis outside of a clinical environment Infusion pumps are also advantageous in that they greatly reduce the frequency of subcutaneous access events such as needle based shots One example of a medicament that may be introduced by an infu sion pump is a liquid formulation of insulin Other exemplary medicaments that may be introduced by an infusion pump include but are not limited to drugs that treat cancers and drugs that suppress the perception of pain Many conventional infusion pumps have improved patient health and quality of life Nevertheless the present inventors have determined that conventional infusion pumps are sus ceptible to a wide range of improvements By way of example but not limitation the present inventors have deter mined that it would be desirable to provide an infusion pump that is smaller more accurate
27. cutaneous delivery of very high concentration insulin e g the U 500 insulin discussed below Nevertheless it should be appreciated that the present inventions are appli cable to a wide variety of infusion pumps and medicaments By way of example but not limitation many of the present inventions are also applicable to infusion pumps that are not cartridge based e g pumps with refillable reservoirs and single use pumps Also the inventions may employ for fluid displacement a cartridge with a plunger a fluid displacement device in the form ofa plunger pusher and a drive mechanism that includes a motor or other fluid displacement devices regardless of the type of cartridge or reservoir employed piston pumps e g electromagnet pumps MEMS pumps peristaltic pumps and any other suitable pumps as well as corresponding drive mechanisms Exemplary infusion pumps that include a cartridge with a plunger a fluid displacement device in the form ofa plunger pusher and a drive mechanism are described in U S patent application Ser No 12 890 207 filed Sep 24 2010 which is hereby incorporated by reference in its entirety The present inventions are also applicable to medicaments such as for example drugs to mask pain che motherapy and other cancer related drugs antibiotics hor mones GLP 1 Glucagon various other drugs that include large molecules and proteins that may require a high level of delivery accuracy as well as to relat
28. ded to among other things detect occlusions in a cannula or infusion set tube Occlusions may occur for any number of reasons including but not limited to cannula kinks caused by move ment of the pump assembly relative to a deployed cannula kinks in the infusion set tube or granuloma formation at the outlet end of a cannula The structures that are used to sense pressure may also be used to for example sense baseplate assembly attachment medicament cartridge presence and or alignment within a pump assembly In at least some imple mentations one portion ofthe pressure sensor may be part of the medicament cartridge and another portion of the pressure sensor may be part of the pump assembly Other exemplary detectable structure arrangements include but are not limited to a magnetically permeable structure carried on a diaphragm and movable relative to a coil and an optical element carried ona diaphragm and movable relative to an optical sensor and an electrical conductor carried on a diaphragm and movable relative to a pair of switch contacts It should also be noted that with respect to the implementations that include a pres sure sensor the present inventions are not limited to pressure sensor arrangements that include a diaphragm or to pressure sensor arrangements that include a cartridge portion and a pump assembly portion For example a medicament car tridge may include a pressure sensor that communicates with the pump assembl
29. e 2003 0216683 Al 11 2003 Shekalim 6458102 10 2002 Mann etal 2003 0233069 1 12 2003 Gillespie et al 604 131 6 461 331 Bl 10 2002 Van Antwerp 2004 0003493 Al 1 2004 Adair et al 6 482 186 B1 11 2002 Douglas et al 2004 0078028 Al 4 2004 Flaherty et al 6 520 930 B2 2 2003 Critchlow et al 2004 0085215 Al 5 2004 Moberg et al 6 537 251 B2 3 2003 Klitmose 2004 0092865 Al 5 2004 Flaherty 6 585 695 Bl 7 2003 Adair et al 2004 0092873 Al 5 2004 Moberg 6 585 698 7 2003 Packman et al 2004 0092878 Al 5 2004 Flaherty 6 629 949 B1 10 2003 Douglas 2004 0127844 7 2004 Flaherty 6 641 566 B2 11 2003 Douglas et al 2004 0133166 Al 7 2004 Moberg et al 6 656 158 B2 12 2003 Mahoney et al 2004 0138612 Al 7 2004 Shermer et al 6 656 159 B2 12 2003 Flaherty 2004 0153032 AI 8 2004 Garribotto et al 6 659 980 B2 12 2003 Moberg et al 2004 0176727 Al 9 2004 Shekalim 6 692 457 B2 2 2004 Flaherty 2004 0220551 Al 11 2004 Flaherty et al 6 699 218 B2 3 2004 Flaherty et al 2004 0235446 Al 11 2004 Flaherty et al 6 723 072 B2 4 2004 Flaherty et al 2004 0243065 Al 12 2004 McConnell et al 6 736 796 B2 5 2004 Shekalim 2005 0021000 Al 1 2005 Adair et al 6 752 787 Bl 6 2004 Causey et al 2005 0021005 Al 1 2005 Flaherty et al 6 768 425 B2 7 2004 Flaherty et al 2005 0022274 A1 1 2005 Campbell et al 6 800 071 10 2004 McConnell et al 2005 0065472 Al 3 2005 Cindrich et al 6 817 990 B2 11 2004 Yap et al 2005 0090808 Al 4 2005 Malave et al
30. e assembly in accordance with at least one of the present inventions includes a baseplate a medicament car tridge on the baseplate defining a reservoir a cannula and a cannula inserter The features and attendant advantages of the present inven tions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings BRIEF DESCRIPTION OF THE DRAWINGS Detailed description of exemplary embodiments will be made with reference to the accompanying drawings FIG 1 is an exploded perspective view of an exemplary infusion pump kit including an infusion pump assembly and three baseplate assemblies FIG 2A is a schematic view showing use of an exemplary infusion pump system FIG 2B is a schematic view showing use of an exemplary infusion pump system FIG 3 is a perspective view of an exemplary pump assem bly FIG 4 is a bottom view of the exemplary pump assembly illustrated in FIG 3 FIG 5 is perspective view of the exemplary pump assem bly illustrated in FIG 3 with a baseplate attached and asso ciated cartridge inserted FIG 6 is a perspective view of an infusion pump assembly being attached to a battery recharging device FIG 7 is a graph showing recharging temperature during an exemplary battery recharging method FIG 8 is a flow chart showing an exemplary baseplate assembly removal and replacement method FIG
31. e difficult for the battery 238 to provide enough current if the temperature within the pump housing 202 is low The temperature sensor 239 may therefore be used to monitor temperature during operation of the pump assembly 200 An alarm may be actuated by the recharge controller if the temperature is too low In at least some implementations the recharge controller may be configured to identify and or prevent charging faults such as battery overcharge that can cause the battery to swell vent and otherwise stress other components within the pump assembly With respect to the amount of time until the rechargeable battery 238 requires recharging the pump assembly may be provided with a battery management chip or other suitable battery management apparatus that determines when recharging is necessary For example recharging may be necessary when the battery voltage is reduced from the fully charged voltage to a predetermined voltage that is less than the fully charged voltage The amount oftime remaining may be estimated by the battery management apparatus based on factors such as battery age battery temperature and the dis pensing program The battery management apparatus may be part of oroperably connected to the pump assembly control ler The controller is configured to generate a signal indicative of the amount of time remaining until the battery will require recharging Alternatively and in particular when using the baseplate ene
32. er No 12 890 207 a wide range of resis tance values are possible by employing a variety of resistors two contacts on the baseplate assembly and two contacts on the pump assembly At the most basic level use of the exemplary infusion pump system 10 or 11 etc illustrated in FIG 1 involves obtaining a new baseplate assembly 300 or 301 etc con necting the baseplate assembly to the pump assembly peeling the cover from the baseplate adhesive layer gaining subcuta neous access and initiating a medicament delivery operation In some instances use may involve additional steps such as removing the cover from baseplate energy supply 400 if a Zinc air battery is employed or pulling the pull before use plug 110 from cartridge 100 of the baseplate assembly if necessary Various aspects of the basic operation of the present systems are described below Operation of a system does not necessarily require all of the steps each time the system is deployed and the order of some ofthe steps may be changed Operation is also discussed below in the exemplary context ofthe above described pump assembly 200 and patch pump baseplate assembly 300 through the use ofa flow chart FIG 8 as well as through illustrations of the exemplary system itselfin various states FIGS 9 14 The discussion is however equally applicable to other patch pump implemen tations as well as to pocket pump implementations with minor variations Also unless otherwi
33. ess may be required for a cannula insertion process such as that described below with reference to FIGS 10 13 The top wall 214 of the housing 202 may also be provided with a cartridge opening 226 for the top of cartridge 100 The inserter opening 224 and cartridge opening 226 are merged into a single opening in the illustrated embodiment Such openings may be separate in other embodiments Cartridge opening 226 facilitates observation of the medicament and plunger within a cartridge formed from transparent material Additionally in the illustrated embodiment the pump assem bly 200 is configured 1 sized shaped etc such that a portion of the associated cartridge e g cartridge 100 may protrude through the cartridge opening 226 when the base plate assembly is in place and the cartridge is in the cartridge receiving area 220 For example the relative configurations of the baseplate assembly 300 cartridge 100 and pump assembly 200 may be such that the cartridge body protrudes slightly e g about 0 40 1 00 mm or five percent of the reservoir volume through the opening 226 in the housing top wall 214 as is illustrated in FIG 5 The bulk of the cartridge body will however be located below the inner surface of the top wall 214 The length of the cartridge opening 226 is substantially equal to the length of the cartridge reservoir with appropriate clearance while the width is somewhat less than the diameter of the cartridge For
34. evel is low A wide variety of baseplate identification instrumentalities and identification methodologies may be employed and the present inventions are not limited to any particular instrumen talities and methodologies Various illustrative examples of such instrumentalities and identification methodologies are described in U S patent application Ser No 12 890 207 filed Sep 24 2010 In one such example baseplate assem blies 300 301 and 302 may have respective identification devices 582 0 582 1 and 582 2 see FIG 1 each of which includes a pair of electrical or optical contacts or the like that align and electrically or optically couple or the like to a respective two of the three electrical or optical contacts 228 230 and 232 or the like associated with the pump assembly FIG 4 when a baseplate assembly is secured to the pump assembly For instance the pump assembly controller may cause voltage to be applied across the pump assembly elec trical contacts 228 230 and 232 and may measure resistance or another suitable variable between contact pairs 228 230 230 232 and 228 232 The pump assembly controller may store information which indicates the resistance levels that 20 25 30 35 40 45 50 55 60 65 14 correspond to particular baseplate assemblies and use the resistance measurement to identify the attached baseplate assembly In one of the other examples described in U S patent application S
35. ference numerals To that end the pump assembly 200 includes a housing 202 with an inserter opening 224 and cartridge opening 226 and the other internal components described above The baseplate assembly 300 includes a baseplate 500 an energy supply 400 a medicament cartridge 100 with a manifold and an inserter 800 with a cannula that are attached to one another in the manner shown The inserter opening 224 is configured to permit passage of the inserter 800 when the pump assembly 200 is placed over baseplate assembly 300 After the pump assembly 200 and cartridge assembly 300 are secured to one another the can nula may be deployed and the inserter 800 removed from the baseplate assembly 300 Various methodologies are presented here in the context of the exemplary structures described in the preceding sections and illustrated in FIGS 1 17 for the purpose of explanation only Although the present methodologies may employ the structures described above they are not limited thereto Addi tionally the alarms reports and other notifications associated with the methodologies described below may be provided in audible visible and or tactile form A pump assembly may provide audible visible and or tactile notifications A remote control may also provide audible visible and or tactile noti fications as an alternative to or in addition to any notifica tions provided by a pump assembly Additionally embodi ments of the
36. figurations of the pump assem bly 200 and battery recharger 700 are such that when the pump assembly is placed on the plate 706 with an end wall 212 abutting the hook 714 the pump assembly recharge con tacts 228 and 230 will be electrically connected to the recharger contacts 228R and 230R It should be noted here that the present pump assemblies and battery rechargers are not limited to those which make a direct electrical connection through the use of electrical con tacts By way of example but not limitation inductive cou pling may be employed In addition or as an alternative to the above rechargeable battery 238 may be recharged by the baseplate energy supply 400 carried on baseplate 500 502 see FIG 1 Referring to FIG 15 the exemplary energy supply 400 includes a housing 402 and an energy storage device 404 within the housing Any suitable energy storage device may be employed Exemplary energy storage devices include but are not limited to primary cell batteries fuel cells and capacitive storage devices Exem plary primary cells include alkaline batteries and Zinc air batteries including those in the form of small button cells of the type commonly used in hearing aids Such batteries are sometimes referred to as disposable batteries The energy supply also includes a pair of flexible electrical contacts 406 and 408 that are respectively connected to the anode and cathode of the energy storage device 404 A seal 410 s
37. he user separately as user replaceable parts Whether configured as a pocket pump or a patch pump the system may be configured to provide basal delivery of medicament in accordance with a delivery profile provided by a physician by way of a clinician s programming unit For example the system may include a program that stores a number of delivery profiles e g delivery profiles associated with a 24 hour delivery cycle delivery profiles for particular situations such as sleep or illness and the like Each delivery profile specifies multiple doses or pump over time e g a particular number of doses at particular times or a particular number of doses per unit time In some imple mentations a dose may be the volume associated with the minimum controllable displacement of a cartridge plunger The system may also be configured to provide bolus delivery in response to an instruction from a patient remote control A bolus instruction may come in response to a high glucose level measurement in the case of a diabetic patient an increase in pain level in the case of a pain management patient or some other symptom The system may also be configured to perform other functions such as ending medi cament delivery in response to instructions from a patient remote control The present infusion pumps may be used in conjunction with a wide variety of remote controls Such remote controls may be used to for ex
38. ied structure e g a baseplate assembly adjust for a current or anticipated change body condition e g low glucose vigorous exercise follow a physician s suggestion or disconnect the pump assembly from the body for any other reason The exemplary remote control 1000 may be configured to generate an indicator based on information from a controller for pump assembly 200 that is indicative of the amount of time remaining in the current dispensing program and or the amount of time until the next baseplate assembly replacement and or the amount of time until the pump assembly battery requires recharging The indicator may be audible visible palpable or combinations thereof A time remaining indicator may be useful for a variety of reasons For example knowl edge of the time remaining prior to next baseplate assembly replacement allows the patient to determine based at least in part on the current time of day and upcoming events e g travel or sleep whether or not it would be more convenient to replace the baseplate assembly at a time prior to the end ofthe dispensing program The system may also be provided with baseplate assem blies configured for different concentrations of medicament such as different types of insulin For instance U 100 insulin is a relatively low concentration insulin containing 100 inter national units IU of insulin activity per 1 ml and accord ingly a 2 ml cartridge reservoir stores 200 IUs One com
39. ion is made e g baseplate assembly 300 versus baseplate assembly 301 the pump assembly will proceed in a manner or mode of operation that is appropriate for the attached baseplate assembly For example if baseplate assembly 300 is detected the pump assembly controller will not including priming as part of the delivery process and in some implementations will prevent the user from manually implementing a priming procedure Tf on the other hand baseplate assembly 301 is detected then the delivery process may include appropriate priming of the infusion set tube Inother embodiments the identification process may addi tionally or alternatively distinguish between baseplate assem blies with cartridges containing different medicaments dif ferent concentrations of a medicament and or varying amount of medicaments For instance if the pump assembly determines that the baseplate assembly is carrying a high concentration medicament such as U 500 insulin it can appropriately adjust the dispensing program If on the other hand the pump assembly senses a baseplate assembly with a lower concentration medicament such as U 100 or U 200 insulin it can provide a proper dispensing program for that concentration As another example the pump assembly may detect a baseplate assembly with a certain amount of medi cament and make appropriate adjustments to for instance display the medicament level and or warn the patient when the medicament l
40. ively high concentration insulin i e U 200 and above such as U 500 insulin As noted above some ambulatory infusion pumps are intended to be worn on a belt carried in a pocket or otherwise supported within a holder of some kind referred to collec tively as pocket pumps Such infusion pumps transfer fluid from a reservoir to an infusion set by way of an elongate tube Subcutaneous access may be obtained by way ofa cannula in the infusion set Other ambulatory infusion pumps are intended to be adhered to the skin at the delivery site some times referred to as patch pumps Here the cannula or other subcutaneous access device may extend directly from the infusion device Given these modes of use patients typi cally prefer the pump to be as small as possible so that the pump will be more comfortable less obtrusive and less vis ible In addition patients want a device that is easy and convenient to use Exemplary ambulatory infusion systems which are gener ally represented by reference numerals 10 11 and 12 in FIG 1 include a medicament cartridge or cartridge 100 an ambulatory infusion pump assembly or pump assembly 200 and one of the baseplate assemblies 300 301 and 302 The baseplate assemblies 300 301 and 302 each include an energy supply 400 and a respective baseplate 500 501 and 502 The baseplates 500 501 and 502 are configured to be attached to the pump assembly 200 and to that end each incl
41. l 1 V from the energy storage device 404 to a voltage that is greater than the voltage of the battery 238 e g greater than a nominal 3 7 V to recharge the rechargeable battery 238 In some implementations the recharging process may be controlled by the pump assembly controller such as by circuitry 237 associated with the pump assembly control ler or by other circuitry such as dedicated circuitry or a DC to DC converter semiconductor chip or some combina tion thereof In such implementations the pump assembly controller or processor circuitry etc may monitor the pri mary battery voltage and actively control the recharging pro cess such as when to commence or cease charging In other embodiments the recharge process and or primary battery voltage may not be controlled or monitored and the recharg ing proceeds until the primary battery is exhausted Given the relatively close proximity of the rechargeable battery 238 to the medicament cartridge 100 heat from the battery 238 could possibly increase the temperature of the medicament during recharging especially during rapid recharging The medicament temperature may be relevant to certain medicaments such as insulin for example which can be damaged and have its viability become undefined at about 37 C Accordingly a temperature sensor 239 e g a ther mistor or thermocouple may also be carried within the pump assembly housing 202 in such a manner that the temperature senso
42. layer 542 as illustrated in FIGS 9 and 10 Steps S116 and 117 Also shown in FIG 10 is an exemplary cannula inserter 800 with cannula 600 in its initial position prior to insertion The inserter 800 may include a movable member 802 within a housing 804 anda trigger type actuator 806 that acts on the movable member The exemplary actuator 806 may have a rotatable or pressable trigger 808 and a com pressed spring or other biasing device 810 A trocar 812 is carried on the movable member 802 A cannula 600 is pre mounted on the trocar 812 such that the sharp distal end ofthe trocar extends beyond the cannula tube 612 The inserter 800 may also be configured to withdraw the trocar back into the housing 804 after the cannula is deployed Inother embodiments the initial position of cannula 600 is at least partly within through bore 116 such that plug 110 is unnecessary When cannula 600 is initially positioned within through bore 116 it provides a seal against the medicament outlet 117 of the cartridge 100 As such plug 110 may be omitted from these embodiments In these embodiments the sharp distal end of trocar 812 is entirely within through bore 116 while in the initial position prior to cannula deployment to prevent accidental contact by the user In addition with cannula 600 in this lower initial position cannula inserter 800 may be modified to not extend as far above cartridge 100 as in FIG 10 see for instance FIG 17 while re
43. lling by the manufacturer of the car tridge and or the medicament can be accomplished without any substantial introduction of air bubbles using for example a vacuum filling procedure Referring to FIG 10 the exemplary medicament cartridge 100 may include a barrel 102 that defines a medicament reservoir 104 a plunger 106 and a manifold 108 The mani fold 108 which may include a through bore 116 may be used to connect the reservoir to for example cannulas and base plate structures The plunger 106 moves within the cartridge to vary the volume of medicament within the reservoir The cartridge 100 may also be provided with a plug 110 that prevents leakage from a prefilled reservoir e g prefilled in a vacuum with U 500 insulin during packaging shipping storage and handling and can be manually removed by the user At least some of the exemplary implementations may employ pressure data in various contexts For example a pressure sensor may be used to detect occlusions that are impeding or completely preventing medicament flow To that end a medicament cartridge may include some or all of the pressure sensor itself The pressure sensor may also be used to detect the presence of a cartridge in the pump assem bly as is also described below Briefly the exemplary pump assembly 200 may include an external housing housing which is generally represented by reference numeral 202 in FIG 3 and a pump module that is located wi
44. mon insulin dose is 0 5 IU which equates to a dispensed volume of 5 microliters of U 100 per dose 400 doses per 2 ml reservoir and about 4 5 days of therapy at the common dos age However higher concentration insulins are commer cially available Humulin R U 500 insulin which is avail able from Eli Lilly and Company in Indianapolis Ind contains 500 IU ml Additionally or alternative different baseplate assemblies may be configured for different medi cament fill volumes to correspond to the amount of medica ment used in the baseplate assembly lifetime Therefore a variety of baseplate assemblies can be provided containing different concentrations and or amounts of medicament such as various concentrations and or units of insulin In addition to baseplate assembly packaging and labeling the different baseplate assemblies may include visual cues to differentiate the various baseplate assemblies For instance baseplate assemblies with different concentrations of medicament or different medicament fill volumes may use different colors for the cartridge and or baseplate of the baseplate assembly 20 25 30 35 40 45 50 55 60 65 6 When a baseplate assembly is attached to the pump assem bly the pump assembly may automatically detect the version of baseplate assembly that was attached as described further below Alternatively the patient or a clinician may program the pump such as via a remote cont
45. nt cartridge Priming is however required to fill the infusion set tube FIG 1 in a pocket pump configu ration prior to the onset of medicament delivery For instance 20 30 ul may be required to fill the entire infusion set tube US 8 905 972 B2 13 and accordingly the priming procedure may involve the rapid delivery of 10 15 IUs of U 500 insulin to the tube The present inventors have determined that it would be advanta geous to prevent users from initiating a priming procedure when the system is in the patch pump configuration with a cannula positioned to deliver medicament essentially directly from the medicament cartridge to the patient because rapidly delivering 10 15 IUs of insulin to the patient could adversely affect patient health To prevent such undesirable outcomes and for user con venience in other situations involving the choice between a variety of baseplate assemblies at least some of the present baseplate assemblies may be provided with a baseplate iden tification device and at least some ofthe present pump assem blies may be provided with structure that cooperate with a baseplate identification device in such a manner that the pump assembly controller can make a baseplate type determina tion For example the baseplate identification devices may be carried by the baseplates and may be detectable by the pump assembly as well as distinguishable from one another Once the baseplate type determinat
46. nt cartridge with a reservoir and a through bore in fluid communication with the reservoir a cannula configured to fit within the through bore and a cannula inserter wherein the infusion pump assembly and the baseplate assembly are configured to be attached to one another in such a manner that energy from the baseplate energy supply is transferred to the rechargeable battery 11 An infusion pump system comprising an infusion pump assembly including a housing with a bottom surface a fluid cartridge receiving area and a fluid cartridge insertion opening that extends through the bottom surface to the fluid cartridge receiving area and a rechargeable battery within the housing and a baseplate assembly including a baseplate and a baseplate energy supply wherein the infusion pump assembly and the baseplate assembly are configured to be attached to one another in such a manner that the baseplate covers the fluid car tridge insertion opening and energy from the baseplate energy supply is transferred to the rechargeable battery 12 An infusion pump system as claimed in claim 11 wherein the baseplate energy supply comprises a battery 13 An infusion pump system as claimed in claim 11 wherein the baseplate include a top surface that faces the infusion pump assembly when the infusion pump assembly and the baseplate assembly are attached to one another a bottom surface opposite the top surface and adhesive on the bottom surface
47. r can sense the temperature of the medicament in the cartridge 100 or a temperature that is at least representative thereof For example the temperature sensor 239 may be carried on the circuit board associated with the exemplary pump assembly controller Temperature sensing apparatus such as a heat pipe that extends to the reservoir not shown may also be included on some cartridge implementations The temperature information may be provided to the pump assembly controller or to other circuitry such as in recharger 700 or another controller collectively referred to as the recharge controller to modulate the battery recharging process as a function of temperature sensed by temperature sensor 239 Modulation of the recharging process may be accom plished by for example selectively increasing or decreasing the rate at which the battery 238 is recharged e g by con trolling current as a function of sensed temperature For example and referring to FIG 7 the modulation process may be designed to perform temperature control in a manner that prevents the sensed temperature from overshooting the pre determined maximum temperature T as shown by the dashed lines To that end as temperature reaches a modula tion temperature below the maximum temperature US 8 905 972 B2 11 T4 the recharging rate is reduced to keep the temperature at or below the maximum temperature T Itshould also be noted that it may b
48. rgy supply 400 with the baseplate assembly the recharge able battery 238 is recharged to full capacity each time a new baseplate assembly is attached to the pump assembly In other words when the patient requires or desires a new medicament cartridge the new baseplate assembly will include the base plate energy supply 400 which will recharge the rechargeable battery The rechargeable battery 238 under normal opera tion e g with no battery failure or discharge problems will maintain a charge longer than the time it takes to empty cartridge 100 As such ifthe system is operating as usual the patient will not receive a message that rechargeable battery 238 needs to be recharged As noted above and as illustrated for example in FIGS 1 2A and 2B the present infusion systems may include any one of a variety of different baseplate assemblies shown without cartridge 100 and inserter 800 for ease of differentiation in combination with a pump assembly e g pump assembly 200 As an example FIG 17 illustrates an exemplary base plate assembly 300 that includes baseplate 500 inserter 800 cartridge 100 and baseplate energy supply 400 Each base plate assembly may be configured for a different mode of system operation For instance baseplate 500 is a body adher able baseplate that may be used in conjunction with a cannula such as cannula 600 connected to the cartridge 100 so the system may be deployed as a patch pump Basepl
49. rol to indicate the type of baseplate assembly attached In a manner such as this a patient can access a variety of medicaments for use with a single pump assembly As such parts ofthe present systems may be considered the reusable parts while other parts may be considered the dis posable parts In the illustrated embodiments the pump assembly 200 which includes structures such as the motor and various mechanical structures the pump assembly con troller and a rechargeable battery is reusable while the base plate assembly which may include some or all of a baseplate such as one of the baseplates 500 502 a cartridge 100 an energy supply 400 a cannula 600 and a cannula inserter 800 is disposable Another disposable baseplate assembly 300 is shown in FIG 17 The exemplary system is as noted above a cartridge based system in that medicament cartridges 100 which may or may not be included as part of baseplate assembly 300 or 301 are inserted into the pump assembly 200 and later removed from the pump assembly The cartridges 100 may also be but are not required to be prefilled and disposable Prefilled car tridges are advantageous for a variety of reasons By way of example but not limitation some users prefer to avoid car tridge filling procedures because they are inconvenient and tend to involve needles User based refilling also increases the likelihood that air bubbles will be introduced into the cartridge while prefi
50. se indicated the actions and determinations performed by the pump assembly 200 are controlled by the pump assembly controller and fur ther references to the controller are omitted in the interest of brevity Referring first to FIG 8 use of the present systems may involve removal of a baseplate assembly from a pump assem bly This may occur in some instances automatically when the medicament cartridge is empty e g when the plunger pusher 250 is at the end of the pusher stroke as described in more detail in U S patent application Ser No 12 890 207 Step S101 and a replace baseplate assembly message or alert is presented Step S102 or when the pump assembly controller receives a user initiated replace baseplate assem bly signal from the remote control 1000 Step S103 The user may desire to replace a baseplate assembly before the medicament cartridge is empty for a variety of reasons such as for example to accommodate the user s sleep or travel schedule when the medicament appears cloudy or otherwise exhibits a loss of effectiveness when a dispensing problem arises or due to a prescribed change in medicament Whether automatic or user initiated the plunger pusher 250 will be returned to the fully retracted home position Step S104 The user may then obtain a new baseplate assembly such as baseplate assembly 300 shown in FIG 1 containing cartridge 100 energy supply 400 baseplate 500 cannula 600 and inserter 800 or
51. taining the above described or similar components to similarly insert cannula 600 into operating position as described below Thus these embodiments may remove the need for plug 110 while making baseplate assembly 300 more compact and retaining all of its other capabilities Turning to FIG 11 the unit consisting of the pump assem bly 200 baseplate assembly 300 including cartridge 100 baseplate 500 energy supply 400 cannula 600 and inserter 800 may be adhered to the skin surface S Step S118 The inserter actuator 806 may then be actuated FIG 12 such as by pressing or by rotating a trigger 808 thereby allowing spring 810 to drive movable member 802 towards the patient Step S119 At the end of the movable member stroke the proximal portion of cannula 600 will be properly seated in the cartridge through bore 116 and the distal end of cannula 600 will be subcutaneously deployed The inserter 800 may then be removed FIG 13 Step 120 In some implementations the pump assembly may be pro vided with structure not shown that performs the function of determining whether or not the cannula is properly inserted Step S121 If the cannula is not properly inserted an error message will be provided to the user Step S122 Finally as shown in FIG 14 the remote control 1000 may be used to initiate a particular medicament delivery operation Step S123 The delivery operation may follow a predeter mined delivery profile e g a p
52. th the operational mode associated with that baseplate assembly Also although the exemplary baseplate assemblies are described herein in the context of the exemplary cartridge 100 and the exemplary pump assembly 200 the present base plates and baseplate assemblies may be used in conjunction with other cartridges cartridge based pumps and pumps that are not cartridge based Exemplary baseplates for use with the baseplate assem blies of the present inventions exemplary cannula designs fluidic connection between a medicament cartridge and the cannula cooperation between the cannula and baseplate assemblies for instance to prevent axial movement of the cannula relative to the baseplate and patient attachment of an infusion set to the cartridge of the baseplate assembly con figurations and uses of a non delivery baseplate arrange ments and structures for attaching baseplate and pump assem blies skin adhesive designs occlusion sensors and various inserters may be as described in U S patent application Ser No 12 890 207 filed Sep 24 2010 The dimensions of the baseplate assembly may correspond to those of the associated pump assembly In the context of the exemplary pump assembly 200 described above the plate member may be 1 mm thick with length width relationships such as 42 mmx34 mm 40 mmx32 mm and or 39 0 43 0 mmx31 0 35 0 mm It should also be noted that the present inventions include kits which contain various combina
53. thin the housing and is therefore not shown Other structures that may be carried within the housing 202 include but are not limited to a rechargeable battery a pump assembly controller and associated circuitry 237 FIG 6 and an alarm When the baseplate assembly is attached to the pump assembly and medicament cartridge 100 is in opera tional position within the pump assembly 200 the cartridge plunger 106 will be proximate to and facing a plunger pusher 250 of the pump module see FIG 10 A drive mechanism of the pump module may then drive the plunger pusher relative US 8 905 972 B2 7 to the cartridge plunger to controllably and precisely dispense medicament from the cartridge reservoir As noted above the exemplary pump assembly 200 may include an alarm that is carried within the housing 202 The alarm may be audible e g a buzzer palpable e g a vibra tor visible e g an LED with a portion that extends through the housing 202 and or any combination thereof A number of conditions may result in alarm activation in the exemplary embodiments For example alarm conditions include but are not limited to low or dead battery occlusion low or empty reservoir hardware self test firmware error absence of a baseplate device fall off baseplate pump assembly discon nection battery charge over temperature telemetry fault motor error unable to find plunger and or charging faults Referring to FIGS 3 4 the housing 2
54. tions of baseplates at least two of the baseplates being different Additionally or alternatively kits or other packages may include various baseplate assembly components such as medicament car tridges and or cannula inserter as user replacements Kits may also include a pump assembly The baseplate assemblies in such kits may also include the detection instrumentalities discussed below The components of the present kits e g combination of various baseplate assemblies and or compo nents may be stored in a common package with individual packages for each component if necessary and provided to the user in the common package Other components that may be provided in such kits include but are not limited to insert ers that are preloaded with a cannula and cleaning swabs A recharger may also be provided in a kit that includes a pump assembly It should be noted here that but for the issue of priming the dispensing procedures associated with an infusion system patch pump configuration which may include a pump assembly 200 and a baseplate assembly 300 are substantially the same as the dispensing procedures associated with a pocket pump configuration which may include a pump assembly 200 and a baseplate assembly 301 see FIG 1 With a patch pump configuration priming is not necessary because the volume of the associated cannula will be very small and there is a direct connection between the cannula and the medicame
55. uch as an o ring seal extends around the base of the energy supply housing 402 As noted above the baseplate energy supply 400 projects into the baseplate energy supply receiving area 222 when a baseplate assembly e g baseplate assembly 300 is attached to the pump assembly 200 To that end the receiving area 222 is defined by a side wall 260 and an end wall 262 that are formed in the bottom wall 216 of the housing 202 A pair of electrical contacts such as the illustrated annular contact 264 and circular contact 266 are located on the end wall 262 The contacts 264 and 266 are connected to the circuitry 237 The respective configurations of the receiving area 222 and the baseplate energy supply 400 are such that the energy supply contacts 408 and 408 will engage the receiving area contacts 264 and 266 and the seal 410 will engage the side wall 260 to prevent moisture ingress when the baseplate assembly 300 is connected to the pump assembly 200 Tt should also be noted here that the present inventions are not limited to the exemplary receiving area 222 and baseplate energy supply 400 described above For example the base plate energy supply 400 may be provided with other types of flexible or otherwise outwardly biased electrical contacts Alternatively or in addition the receiving area 222 may be provided with flexible or otherwise outwardly biased electri cal contacts One or both sets of electrical contacts may also be eliminated
56. udes a plate member 510 a pair of opposing connectors 512 and a hook 514 The baseplates 500 501 and 502 are also configured for different modes of system operation Baseplate 500 is a body adherable baseplate that may be used in conjunction with a cannula 600 that is directly connected to the cartridge 100 so that the system 10 may be deployed as a patch pump by securing the baseplate to the patient s skin FIG 2A Base plate 501 is configured to connect the cartridge 100 to an infusion set 503 so that the system 11 may be deployed as a pocket pump a belt worn pump or some other wearable 20 25 30 35 40 45 50 55 60 65 4 pump FIG 2B 502 is a medicament non delivery baseplate that may be used to seal the cartridge 100 during periods of non use e g by way of plug 504 thereby defin ing a non use system 12 In other words using the same pump assembly e g pump assembly 200 the user may configure the system for use as pocket pump or a patch pump by simply selecting the appropriate baseplate assembly and attaching the baseplate assembly to the pump assembly The user may also switch from one configuration to another by simply removing one baseplate assembly and replacing it with another baseplate assembly The baseplate assemblies may also be configured for different medicaments such as different medicament concentrations and or different medi cament amounts
57. y by way of electrical contacts The battery that drives the motor may be a rechargeable battery such as a rechargeable lithium polymer battery or a rechargeable lithium ion battery At least some implementa tions will employ a rechargeable battery having a fully charged open circuit voltage of generally about 3 7 Volts or between about 3 0 4 24 Volts One advantage of lithium poly mer and lithium ion batteries is that they can be recharged quickly have high energy density and have desirable linear decay that facilitates accurate charge state indication Turning to FIG 6 the exemplary rechargeable battery 238 may becarried within the pump assembly housing 202 Addi tionally because the battery 238 is rechargeable e g via external recharging contacts 228 and 230 or the baseplate energy supply 400 the exemplary housing 202 does not include a door or a cover to provided access to the battery and the exemplary housing may be sealed 1 it cannot be opened without damage thereto US 8 905 972 B2 9 One example of a battery recharger which is generally represented by reference numeral 700 in FIG 6 includes recharging circuitry 702 e g a controller and power cir cuitry within a housing 704 The top portion of the recharger housing 704 may include a plate 706 a pair of opposing connectors 712 a hook 714 and electrical contacts 228R and 230R Power and data connectors 716 and 718 may also be provided The respective con
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