Multiple use computerized injector
11571516 · 2023-02-07
Assignee
Inventors
Cpc classification
A61M5/3146
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M2005/3125
HUMAN NECESSITIES
A61M5/31593
HUMAN NECESSITIES
A61M5/31578
HUMAN NECESSITIES
A61M2205/14
HUMAN NECESSITIES
A61M2205/3569
HUMAN NECESSITIES
A61M5/31546
HUMAN NECESSITIES
A61M5/482
HUMAN NECESSITIES
International classification
A61M5/20
HUMAN NECESSITIES
Abstract
A computer-controlled injector for use with a medicament cartridge and including a housing having a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with the medicament cartridge receiving volume; a pivot mount element mounted onto the housing for selectably enabling access to the medicament cartridge receiving volume via the opening; a mechanical latch selectably locking the pivot mount element in a closed operative orientation; and an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of the medicament cartridge, for injecting a medicament, the computer-controlled motor also being operative for operating the mechanical latch.
Claims
1. A computer-controlled injector for use with a medicament cartridge and comprising: a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume; a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening; a mechanical latch selectably locking said pivot mount element in a closed operative orientation; a computer interactive user interface including a display and user input facility, said computer interactive user interface providing a prompt to said user to perform a priming function and requiring a confirmatory indication, indicating carrying out of at least part of said priming function before permitting injection to take place; and said computer interactive user interface providing a prompt to said user to perform opening of said pivot mount element, an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament, said injection drive mechanism being responsive to operation of said user input facility for performing said priming function, said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
2. A computer-controlled injector according to claim 1 and also comprising at least one accelerometer indicating the carrying out of part of said priming function.
3. A computer-controlled injector according to claim 1 and also comprising a moveable subassembly, which is linearly displaceable by said computer-controlled motor for linearly displacing said piston and wherein said priming function includes: linear displacement of said piston by said moveable subassembly by a distance sufficient to eject trapped air and a small quantity of medicament from said medicament cartridge.
4. A computer-controlled injector according to claim 1 and wherein said priming function also includes applying a force to said medicament cartridge sufficient to dislodge trapped air bubbles from said medicament cartridge.
5. A computer-controlled injector according to claim 3 and wherein said priming function also includes bringing at least part of said moveable subassembly into contact with said piston such that any linear displacement of said plunger produces a corresponding linear displacement of said piston.
6. A computer-controlled injector according to claim 5 and wherein a change in resistance to operation of said computer-controlled motor indicates said bringing said at least part of said moveable subassembly into contact with said piston such that any further forward linear displacement of said at least part of said moveable subassembly produces a corresponding linear displacement of said piston.
7. A computer-controlled injector for use with a medicament cartridge and comprising: a housing including a medicament cartridge receiving volume, and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume; a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening, wherein said medicament cartridge is configured to be fully inserted into said pivot mount element; a mechanical latch selectably locking said pivot mount element in a closed operative orientation; a computer interactive user interface including a display and user input facility, said computer interactive user interface providing a prompt appearing on said display in a first orientation to said user to perform a priming function including a 180 degrees shift in the orientation of the housing and being responsive to an indication of carrying out of said 180 degree shift, providing a message to said user in a second orientation shifted by 180 degrees from said first orientation; and an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament, said injection drive mechanism being responsive to operation of said user input facility for performing said priming function, and wherein said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
8. A computer-controlled injector according to claim 7 and also comprising at least one accelerometer indicating the carrying out of part of said priming function.
9. A computer-controlled injector according to claim 7 and also comprising a moveable subassembly, which is linearly displaceable by said computer-controlled motor for linearly displacing said piston and wherein said priming function includes linear displacement of said piston by said moveable subassembly by a distance sufficient to eject trapped air and a small quantity of medicament from said medicament cartridge.
10. A computer-controlled injector according to claim 7 and wherein said priming function also includes applying a force to said medicament cartridge sufficient to dislodge trapped air bubbles from said medicament cartridge.
11. A computer-controlled injector according to claim 10 and wherein said priming function also includes bringing at least part of said moveable subassembly into contact with said piston such that any linear displacement of said plunger produces a corresponding linear displacement of said piston.
12. A computer-controlled injector according to claim 5 and wherein a change in resistance to operation of said computer-controlled motor indicates said bringing said at least part of said moveable subassembly into contact with said piston such that any further forward linear displacement of said at least part of said moveable subassembly produces a corresponding linear displacement of said piston.
13. A computer-controlled injector for use with a medicament cartridge and comprising: a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume; a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening, wherein said medicament cartridge is configured to be fully inserted into said pivot mount element; a mechanical latch selectably locking said pivot mount element in a closed operative orientation; a computer interactive user interface including a display and user input facility, said computer interactive user interface providing a prompt appearing on said display in a first orientation to said user to perform a printing function including a 180 degrees shift in the orientation of the housing and being responsive to an indication of carrying out of said 180 degree shift, providing a message to said user in a second orientation shifted by 180 degrees from said first orientation; and an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament, said injection drive mechanism being responsive to operation of said user input facility for performing a priming function, and wherein said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
14. A computer-controlled injector according to claim 13 and also comprising a moveable subassembly, which is linearly displaceable by said computer-controlled motor for linearly displacing said piston and wherein said priming function includes: linear displacement of said piston by said moveable subassembly by a distance sufficient to eject trapped air and a small quantity of medicament from said medicament cartridge.
15. A computer-controlled injector according to claim 13 and wherein said priming function also includes applying a force to said medicament cartridge sufficient to dislodge trapped air bubbles from said medicament cartridge.
16. A computer-controlled injector according to claim 14 and wherein said priming function also includes bringing at least part of said moveable subassembly into contact with said piston such that any linear displacement of said plunger produces a corresponding linear displacement of said piston.
17. A computer-controlled injector according to claim 16 and wherein a change in resistance to operation of said computer-controlled motor indicates said bringing said at least part of said moveable subassembly into contact with said piston such that any further forward linear displacement of said at least part of said moveable subassembly produces a corresponding linear displacement of said piston.
18. A computer-controlled injector according to claim 13 and also comprising at least one accelerometer indicating the carrying out of part of said priming function.
19. A computer-controlled injection method for use with a medicament cartridge and an injector including: a housing including a medicament cartridge receiving volume, and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume; a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening, wherein said medicament cartridge is configured to be fully inserted into said pivot mount element; a mechanical latch selectably locking said pivot mount element in a closed operative orientation; a computer interactive user interface including a display and user input facility; and an injection drive mechanism disposed within said housing and including a computer-controlled motor providing linear displacement of a moveable subassembly for driving a piston, forming part of said medicament cartridge, and wherein said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility; the method comprising: displaying a user prompt to carry out a priming function in a first orientation on said display; responsive to an indication related to at least partial performance of said priming function, displaying a further user prompt in a second orientation on said display, shifted by 180 degrees.
20. A computer-controlled injection method according to claim 19 and wherein said indication indicates reorientation of said housing by approximately 180 degrees.
21. A computer-controlled injection method according to any of claim 19 and wherein said priming function includes bringing at least part of said moveable subassembly into contact with said piston such that any further forward linear displacement of said moveable subassembly produces a corresponding linear displacement of said piston.
22. A computer-controlled injection method according to claim 19 and wherein said indication is provided by at least one accelerometer indicating a change in orientation of said housing.
23. A computer-controlled injection method according to claim 19 and wherein a change in resistance to operation of said computer-controlled motor indicates said bringing said at least part of said moveable subassembly into contact with said piston such that any linear displacement of said moveable subassembly produces a corresponding linear displacement of said piston.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
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DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
(58) Reference is now made to
(59) A multiple use computerized injector (MUCI) for cartridge insertion 100 is seen in
(60) An opening 116 is formed at the rearward end of top housing element 104 and is configured to receive an injection button element 120 thereinto.
(61) It is also seen particularly in
(62) It is additionally seen in
(63) It is seen in
(64) It is particularly seen in
(65) The chassis element 150 is configured to support the internal components of the MUCI 100. A main PCB assembly 152 is seated onto the chassis element 150, and is configured to be operatively coupled with a power control PCB assembly 154 and an electrical motor 158, powered by a battery 160.
(66) It is also seen in
(67) It is seen in
(68) It is noted that pivot mount element 180 is configured to be pivotably coupled to the cartridge enclosure assembly chassis 170, which is in turn configured to be fixedly coupled to chassis element 150, which is fixedly coupled to top housing portion 104.
(69) A needle presence responsive element 190 is adapted to be coupled to the pivot mount element 180 and is configured to be axially displaceable, along longitudinal axis 105, with respect thereto. The needle presence responsive element 190 is biased to a forward position by means of the biasing force of compression springs 192.
(70) A PCB assembly 194 is operatively coupled to the pivot mount element 180 and configured to sense the axial orientation of the needle presence responsive element 190. The PCB assembly 194 is also configured to be operatively coupled to the main PCB assembly 152.
(71) It is further seen in
(72) The locking subassembly 200 preferably includes the cartridge enclosure assembly chassis 170, a cartridge enclosure assembly latch element 210 and typically two compression springs 212, each of which is supported at one side thereof on the cartridge enclosure assembly latch element 210 and at a second side thereof on the cartridge enclosure assembly chassis 170. The cartridge enclosure assembly latch element 210 is configured to be axially displaceable, along longitudinal axis 105, with respect to cartridge enclosure assembly chassis 170 and biased to a forward position under the biasing force of springs 212.
(73) A piston drive subassembly 220 is provided as part of the MUCI 100. When a medicament cartridge having a piston is inserted into the MUCI 100, the piston drive assembly 220 is configured for axially displacing the piston within the medicament cartridge in order to eject fluid therefrom.
(74) The piston drive subassembly 220 preferably includes electrical motor 158, such as a step motor or a DC motor, for example, which is mounted onto a plunger rod element 230 through a threaded nut. Electrical contacts 232 of the electrical motor 158 are adapted to be operatively coupled to power control PCB assembly 154, and following receipt of a suitable signal from the CPU of MUCI 100, the electrical motor 158 causes axial displacement of the plunger rod element 230 with respect to housing portions 102 and 104.
(75) It is seen in
(76) It is a particular feature of an embodiment of the present invention that the piston contact element 240 is configured to operatively couple the plunger rod element 230 to the cartridge enclosure assembly latch element 210, such that rearward displacement of the plunger rod element 230 causes corresponding rearward displacement of cartridge enclosure assembly latch element 210 along longitudinal axis 105. This operative coupling occurs due to the fact that piston contact element 240 pulls the cartridge enclosure assembly latch element 210 rearwardly upon rearward displacement of the plunger rod element 230 along longitudinal axis 105.
(77) Reference is now made to
(78) It is seen in
(79) As previously mentioned, charger inlet 138 is formed in the main housing portion 102 and disposed adjacent the rearward end 280 and speaker outlet 140 is formed in the main housing portion 102 and disposed adjacent the forward end 282.
(80) The main housing portion 102 preferably defines an inner surface 286 and an outer surface 288.
(81) A plurality of snaps 290 are formed on the inner surface 286 of the main housing portion 102 for fixed connection with top housing portion 104. Additionally, two generally upstanding protrusions 292 are formed generally at an intermediate location of the inner surface 286 of the main housing portion 102 for connection to top housing portion 104. Further additionally, protrusions 294 are formed at the forward end 282 of the main housing portion 102 for secure connection with top housing portion 104.
(82) It is additionally seen that an opening 296 for mounting of cartridge enclosure assembly 130 is formed at the forward end 282 of the main housing portion 102.
(83) Reference is now made to
(84) It is seen in
(85) As mentioned above, opening 116 is formed in top housing portion 104 adjacent rearward end 302. Opening 132 extends rearwardly from forward end 300 and opening 110 is formed rearwardly of opening 132.
(86) Transparent window 108 is formed generally between opening 110 and opening 116.
(87) It is particularly seen in
(88) A flat shoulder 312 is formed on one side of the opening 116 configured to act as a stopper for the injection button element 120.
(89) The top housing portion 104 defines an outer surface 314 and an inner surface 316.
(90) It is seen in
(91) An injection button element hinge seating portion 330 is formed on the inner surface 316 adjacent the rearward end 302 of top housing portion 104.
(92) Reference is now made to
(93) It is seen in
(94) There is a plurality of protrusions 370 on the side edges of the button defining element 112 for enabling secure mounting of the button defining element 112 in opening 110 of top housing portion 104.
(95) Reference is now made to
(96) Injection button element 120 has an outer surface 380 to be engaged by a finger of a user and an inner surface 382 with a protrusion 384 extending forwardly therefrom and utilized for engaging main PCB assembly 152 once the injection button element 120 is pressed by the user. Typically, two hinge portions 390 are formed on injection button element 120. Each of hinge portions 390 includes a hinge axle 392, both of which extend along a mutual pivoting axis 394.
(97) Injection button element 120 is configured to be pivotable about pivoting axis 394 in order to selectively activate the injection process of the MUCI 100.
(98) Preferably two protrusions 396 extend from a location on hinge portions 390 configured to lead the springs 164 in order to enable biasing of the injection button element 120.
(99) Reference is now made to
(100) There are typically two generally identical spring support elements 162. Spring support element 162 has a rearwardly facing surface 400 and a forwardly facing surface 402. Raised portions 404 are formed on both the forwardly facing surface 402 and the rearwardly facing surface 400 and preferably two bores 406 and 407 are formed through each one of raised portions 404 and extend longitudinally therethrough along axes 408 and 410, and configured for receiving screws that attach the spring support elements 162 to chassis element 150.
(101) Reference is now made to
(102) Chassis element 150 is configured to be positioned between main housing portion 102 and top housing portion 104 and is used for carrying the piston drive subassembly 220 and to support the cartridge enclosure assembly 130, as well as to support the main PCB assembly 152 and the locking subassembly 200.
(103) Chassis element 150 is generally arranged along longitudinal axis 105 and has an upper side 430 and an underside surface 432. Several generally upstanding protrusions 434 are formed on the upper side 430 and serve to support and align the display 106.
(104) It is particularly seen in
(105) Chassis element also defines a rearward end 442 and a forward end 444.
(106) It is also seen in
(107) Preferably two hinges seats 452 are formed adjacent rearward end 442 of chassis element 150, configured together with hinge seating portions 330 of the top housing portion 104 to receive hinge axles 392 of injection button element 120.
(108) A plurality of apertures 460 are formed on the upper side 430 of the chassis element 150 and are used for insertion of screws for connection of the main PCB assembly 152 to the chassis element 150. Additional apertures 461 are formed on the upper side 430 of the chassis element 150 and are used for insertion of screws for connection of top housing portion 104 to the chassis element 150.
(109) A longitudinal track recess 470 is formed on the underside surface 432 of the chassis element 150, separated by a transversely extending wall 472 from recess 450. Track recess 470 extends longitudinally forwardly along axis 105. A transverse wall 474 separates the track recess 470 from opening 440. A recess 476 is formed in transverse wall 474. There are two protrusions 478 formed on the underside surface 432 of the chassis element, and disposed alongside track recess 470. Protrusions 478 have recesses 479 formed therein.
(110) Opening 440 extends between transverse wall 474 and a wall 480 parallel to wall 474. Wall 480 generally includes a rounded cut-out 482 and a rounded surface 484 extends forwardly from cut-out 482, configured to support electrical motor 158. Adjacent and slightly rearwardly of wall 480, there are two cut-outs 486 formed on a first side wall 490 and a second side wall 492 of chassis element 150, configured to enable a flange of motor 158 to be seated in cut-outs 486.
(111) Wall 480 defines a rearwardly facing surface 494 and typically two openings 496 each formed adjacent a corresponding side wall 490 and 492.
(112) A rearwardly extending track arm 500 extends at each side of rounded surface 484. A recess 502 is formed between track arms 500 and forwardly of rounded surface 484. It is seen that each of track arms 500 has an outwardly facing side surface 504, which joins side walls 490 and 492 respectively. Additionally, a downwardly extending protrusion 510 is formed on the inner facing side of each of track arms 500, configured to cooperate with cartridge enclosure assembly chassis 170 for guiding displacement of cartridge enclosure assembly latch element 210.
(113) Track arms 500 are separated from opening 440 by wall 480. Each track arm 500 defines a forwardly facing edge surface 512 and terminates at a transversely extending forwardly facing surface 514. Track arms 500 are configured for engagement with the cartridge enclosure assembly latch element 210 and prevent deformation thereof.
(114) Partially hexagonal recess 515 extends rearwardly from each of forwardly facing surfaces 514, configured for supporting nuts that are used for connection of electrical motor 158 to chassis element 150.
(115) There is an opening 520 formed between the first side wall 490 of chassis element 150 and track recess 470. Opening 520 is configured for insertion of battery 160 therethrough. An opening 522 is formed between the second side wall 492 of chassis element 150 and track recess 470. Opening 522 is configured for insertion of power control PCB assembly 154 therethrough.
(116) Reference is now made to
(117) As mentioned above, with reference to
(118) The needle presence responsive element 190 is adapted to be coupled to the pivot mount element 180 and is configured to be axially displaceable, along longitudinal axis 105, with respect thereto. The needle presence responsive element 190 is biased to a forward position by means of the biasing force of compression springs 192.
(119) The PCB assembly 194 is operatively coupled to the cartridge enclosure assembly 130 and configured to sense the axial orientation of the needle presence responsive element 190.
(120) It is appreciated that both pivot mount element 180 and cartridge enclosure assembly chassis 170 are arranged along a mutual longitudinal axis 105.
(121) Pivot mount element 180 defines an inner volume 550, which is configured for insertion of a medicament cartridge thereinto. The pivot mount element 180 has a forward end 552 and a rearward end 554. A curved edge surface 556 is formed adjacent the rearward end 554 of the pivot mount element 180, forming a cut-out 557, configured for providing firm grip for the user for inserting or removing a medicament cartridge therefrom.
(122) It is noted that as seen in
(123) Pivot mount element 180 further defines a front wall portion 560 having a central longitudinal opening 562. A generally transparent window 564 is disposed onto front wall portion 560 and is retained in place by means of mounting a cover element 568 thereupon. Cover element 568 has an opening 570 corresponding in shape to opening 562. The window 564 enables medicament inspection within a medicament cartridge by a user.
(124) It is appreciated that window 564 and cover element 568 are formed as an integral part of pivot mount element 180.
(125) Reference is now made to
(126) It is seen in
(127) An opening 620 is formed in portion 602, slightly rearwardly from cut out 606. Opening 620 is configured for releasably retaining the pivot mount element 180 in a closed operative orientation.
(128) Each of spring enclosing fingers 610 has a guiding track 622 formed inwardly thereof adjacent portion 602. Guiding tracks 622 extend generally longitudinally from forwardly facing surface 612 to an upwardly extending wall portion 624, disposed in vicinity of and rearwardly from forward edge 604. Guiding tracks 622 define an upwardly facing generally flat surface 626. The guiding tracks 622 are configured for retaining a portion of the cartridge enclosure assembly latch element 210, as will be further discussed in detail.
(129) A spring seat cut out 630 is formed in each of spring enclosing fingers 610. Spring seat cut-out 630 has a spring aligning pin 632, which is formed on and extends forwardly from a rearward end portion 634 of spring enclosing finger 610. Spring aligning pins 632 are disposed slightly outwardly with respect to guiding tracks 622. Spring seat cut-outs 630 further define a rearwardly facing end surface 638. Spring seat cut-outs 630 are configured to accommodate springs 212 (shown in
(130) It is seen in
(131) It is further seen particularly in
(132) Longitudinal arms 650 extend forwardly from rearwardly facing end surface 638 of spring enclosing fingers 610 to a forward edge 614. An aperture 652 is formed at each of longitudinal arms 650 and extends generally transversely to longitudinal axis 105. Apertures 652 are located adjacent forward edge 614.
(133) Each of arms 650 defines an inwardly facing surface 654, extending from which is an upstanding protrusion 660, which is located adjacent forward edge 614 and a recess 662 formed in the vicinity of the forward end of each upstanding protrusion 660.
(134) Reference is now made to
(135) As mentioned hereinabove, pivot mount element 180 is arranged along longitudinal axis 105 and has rearward end 554 and forward end 552 having outwardly threaded end 184 extending therefrom. The pivot mount element 180 has a front wall portion 560 having opening 562 therewithin and configured for mounting of window 564 and cover element 568 thereon. Pivot mount element 180 also has a rear wall 702, first side wall 704 and second side wall 706.
(136) It is seen in
(137) There are typically four openings 714 formed within recess 710, which are particularly seen in
(138) An opening 720 is formed in side wall 704 for positioning of a portion of PCB assembly 194 therein. Preferably one locking snap element 722 is formed on each of side walls 704 and 706, each snap element 722 is configured to enable locking of pivot mount element 180 relative to top housing portion 104.
(139) A hinge element 730 is disposed on each of side walls 704 and 706, adjacent to forward end 552 of the pivot mount element 180. Hinge elements 730 preferably extend along axis 732, which extends preferably transversely to longitudinal axis 105. Hinge elements 730 serve as the pivoting axis of the pivot mount element 180 relative to cartridge enclosure assembly chassis 170.
(140) Rearwardly facing shoulder surfaces 734 are preferably formed slightly forwardly of each of hinge elements 730, as specifically seen in
(141) It is also seen in
(142) As mentioned hereinabove, rearward end 554 of the pivot mount element 180 defines curved surface 556 forming cut-outs 557, in which an opening 750 is formed, leading to inner volume 550 for insertion of a medicament cartridge thereinto. It is appreciated that cut-outs 557 are configured to provide a firm grip for the user's finger while inserting or removing a medicament cartridge to or from the inner volume 550.
(143) A flange portion 760 is formed at the junction of curved surface 556 and rear wall 702. It is noted that flange portion 760 extends outwardly and preferably at an acute angle with respect to rear wall 702. Flange portion 760 preferably serves for two purposes: configured to engage the cartridge enclosure assembly chassis 170 in order to prevent excessive force exertion on hinge elements 730 to prevent breaking thereof. Additionally, the flange portion 760 is configured for closing the gap created between the inner volume of the MUCI 100 and the cartridge enclosure assembly 130 in order to prevent insertion of objects into the MUCI 100.
(144) A window 762 is formed on rear wall 702 for inspection of medicament in the cartridge once it is inserted into the MUCI 100.
(145) It is specifically seen in
(146) Reference is now made to
(147) It is seen in
(148) Additionally, contacts 786 are seen in
(149) Reference is now made to
(150) Needle presence responsive element 190 includes a generally flat wall portion 800 and a bore 802 formed therein for insertion of externally threaded end 184 of pivot mount element 180 therethrough. Flat wall portion defines a rearwardly facing surface 803.
(151) Protruding rearwardly from wall portion 800 are preferably two snap protrusions 804 and 806. Snap protrusion 806 extends rearwardly further than snap protrusion 804 and includes an engagement portion 808, which is configured to engage the needle sensor 782 of PCB assembly 194.
(152) Protrusions 810 extend rearwardly from wall portion 800 and disposed slightly rearwardly of snap protrusions 804 and 806. Protrusions 810 along with snap protrusions 804 and 806 are configured to be inserted into openings 712 of pivot mount element 180 and serve to guide the mounting of needle presence responsive element 190 onto externally threaded end 184 of pivot mount element 180. Spring seats 811 and protrusions 812 are formed on wall portion 800 and enable alignment of springs 192. At least two of the spring seats 811 and protrusions 812 are configured to bias the displacement of the needle presence responsive element 190 when needle is detached from cartridge enclosure assembly 130.
(153) It is also seen in
(154) The needle presence responsive element 190 is configured to be mounted onto pivot mount element 180 of the cartridge enclosure assembly 130 and is configured to sense the attachment of a needle to the externally threaded end 184 of the pivot mount element 180.
(155) Reference is now made to
(156) In
(157) It is particularly seen in
(158) It is further seen that torsion springs 182 are mounted onto each of hinge elements 730 of pivot mount element 180 and the ends of torsion springs 182 are supported within recesses 662 formed in cartridge enclosure assembly chassis 170 for biasing the pivot mount element 180 into an open operative orientation.
(159) It is also seen in
(160) Reference is now made to
(161) In
(162) It is particularly seen in
(163) It is further seen that torsion springs 182 are mounted onto each of hinge elements 730 of pivot mount element 180 and the ends of torsion springs 182 are supported within recesses 662 formed in cartridge enclosure assembly chassis 170 for biasing the pivot mount element 180 into the open operative orientation.
(164) It is also seen in
(165) Reference is now made to
(166) Cartridge enclosure assembly latch element 210 is preferably an integrally formed element, which is arranged along longitudinal axis 105. It is seen in
(167) Each of the arms 852 and 854 includes an upper portion 870 and a bottom portion 872. It is noted that upper portion 870 is generally wider than base wall portion 850. An upwardly facing guiding track 880 bounded by generally two longitudinal ribs 882 is formed on each of upper portions 870. Each of ribs 882 terminate at a rearwardly tapered surface 884. Upper portions 870 terminate at a forwardly facing tapered surface 886, which is disposed generally forwardly with respect to surfaces 884.
(168) Bottom portion 872 of arm 854 includes a forwardly extending protrusion 890. A cut-out 892 is formed between upper portion 870 and bottom portion 872 of arm 854 and protrusion 890. The cut-out 892 defines a forwardly facing surface 894. Protrusion 890 defines an upwardly facing surface 896, having an upwardly facing protrusion 898, disposed generally at a forward end 900 of protrusion 890. Protrusion 898 is configured to engage cartridge enclosure assembly state sensor 784 (shown in
(169) An arc-shaped protrusion 910 is formed on a forwardly facing surface 912 of base wall portion 850, and is used for tight fit engagement with a rearward end of a medicament cartridge, thereby preventing displacement of the medicament cartridge relative to pivot mount element 180.
(170) Side protrusion 920 generally extends outwardly from upper portions 870 of each of arms 852 and 854. Each side protrusion 920 has a rearwardly extending guiding pin 922. Guiding pins 922 generally serve as a seat for springs 212, complimentary to aligning pins 632 of cartridge enclosure assembly chassis 170.
(171) It is a particular feature of an embodiment of the present invention that cartridge enclosure assembly latch element 210 is configured to electronically lock the pivot mount element 180 with respect to the top housing portion 104.
(172) Reference is now made to
(173) Track element 250 is an integrally made generally U-shaped element extending along longitudinal axis 105. Track element 250 has a base wall portion 940 and two L-shaped arms 942 extending generally transversely therefrom. A partially enclosed tunnel 950 is formed between the base wall portion 940 and arms 942. Each of arms 942 preferably includes a side wall portion 944 and an extension portion 946 extending generally transversely with respect to side wall portion 944. Each of extension portions 946 defines a longitudinal edge 948.
(174) It is additionally seen that a generally upstanding protrusion 952 extends from one of arms 942 and is arranged generally transversely to base all portion 940. Protrusion 952 has typically two openings 954 formed thereon.
(175) Reference is now made to
(176) The main PCB assembly 152 of the MUCI 100 preferably includes an injection button micro switch 960, which is positioned at a rearward end 962 thereof. Main PCB assembly 152 also includes menu button switches 964, CPU 970, USB slot 972 configured to engage PCB assembly 194, buzzer 974, connector 976 configured to engage power control PCB assembly 154, a display connector 978, a home position sensor 980 and a real-time battery 982, which is configured to preserve time stamp in the event of main battery power outage.
(177) Reference is now made to
(178) Power control PCB assembly 154 is provided in the MUCI 100 and shown in
(179) Reference is now made to
(180) It is noted hereinabove that the piston drive subassembly 220 is configured for axially displacing the piston within the medicament cartridge in order to eject fluid therefrom.
(181) The piston drive subassembly 220 preferably includes electrical motor 158, which is mounted onto the plunger rod element 230. The plunger rod element has a forward end 1000, a rearward end 1002 and an external threading 1004.
(182) Piston contact element 240 is mounted onto the forward end 1000 of plunger rod element 230 and anti-rotation element 242 is mounted onto the distal end 1002 of plunger rod element 230. It is also noted that the anti-rotation element 242 is configured to be axially displaced along track element 250.
(183) Piston drive sub-assembly 220 is configured to be mounted onto chassis element 150.
(184) Piston drive sub-assembly 220 preferably includes a moveable subassembly 1005, namely the plunger rod element 230, piston contact element 240 and anti-rotation element 242. The remaining components of piston drive sub-assembly 220 are preferably static.
(185) It is particularly seen in
(186) It is appreciated that the piston contact element 240 is operative to engage the piston within the cartridge and to enlarge the contact surface area between the plunger rod element 230 and the piston within the cartridge. Piston contact element 240 is additionally operative for engaging cartridge enclosure assembly latch element 210 to urge the displacement thereof, as will be described in detail hereinbelow.
(187) It is seen in
(188) It is a particular feature of an embodiment of the present invention that piston drive subassembly 220 includes the plunger rod element 230, the rearward end 1002 of which is inserted into D-shaped bore 1030 of the anti-rotation element 242. Plunger rod element 230 is mounted onto motor 158, and is configured to urge axial displacement of the plunger rod element 230 in order to eject medicament out of the cartridge, upon motor activation, as is described in detail hereinbelow. Electrical contacts 232 are configured to operatively electrically couple the motor 158 to the power control PCB assembly 154.
(189) It is seen in
(190) It is also seen that track element 250 is fixedly attached to chassis element 150 by means of screws inserted into both openings 954 in protrusion 952 of track element 250 and recesses 479 in protrusions 478 of the chassis element 150.
(191) The rearward end 1002 of plunger rod element 230, is inserted into D-shaped opening 1030 of anti-rotating element 242 and fixedly coupled thereto, such that there is no relative movement between the plunger rod element 230 and the anti-rotating element 242. The anti-rotating element 242 is in turn inserted into tunnel 950 defined by track element 250, such only axial relative displacement is permitted between the plunger rod element 230 and the track element 250. The plunger rod element 230 extends forwardly from track element 250, through recess 476 of chassis element 150.
(192) Reference is now made to
(193) It is mentioned above with reference to
(194) The locking subassembly 200 preferably includes the cartridge enclosure assembly chassis 170, cartridge enclosure assembly latch element 210 and two compression springs 212, each of which is support at one side thereof on the cartridge enclosure assembly latch element 210 and at a second side thereof on the cartridge enclosure assembly chassis 170. The cartridge enclosure assembly latch element 210 is configured to be axially displaceable, along longitudinal axis 105, with respect to cartridge enclosure assembly chassis 170 and biased to a forward position under the biasing force of springs 212.
(195) It is a particular feature of an embodiment of the present invention that the operative orientation of the locking subassembly 200 depends on the axial position of part of the moveable subassembly 1005 of the piston drive subassembly 220, as will be further described in detail. Particularly, when the moveable subassembly 1005 of the piston drive subassembly 220 is disposed in its forward operative orientation, cartridge enclosure assembly latch element 210 is urged to be displaced axially forwardly along longitudinal axis 105, under the force of compression springs 212, and thus causing the locking subassembly 200 to assume its locked operative orientation. When the moveable subassembly 1005 of the piston drive subassembly 220 is disposed in its rearward operative orientation, the cartridge enclosure assembly latch element 210 is pulled rearwardly by piston contact element 240 and urges the locking subassembly 200 to assume its unlocked operative orientation. When the moveable subassembly 1005 of the piston drive subassembly 220 is disposed in a predetermined intermediate operative orientation, the cartridge enclosure assembly latch element 210 is not fully displaced forwardly, thus positioning the locking subassembly 200 in a snapped operative orientation.
(196) It is specifically seen in
(197) It is additionally seen that first and second arms 852 and 854 of cartridge enclosure assembly latch element 210 are configured to be at least partially seated within spring enclosing fingers 610 of cartridge enclosure assembly chassis 170. It is particularly seen that upper portions 870 of arms 852 and 854 are received within spring seat cut-outs 630 of spring enclosing fingers 610 of cartridge enclosure assembly chassis 170 and rearwardly extending guiding pins 922 of cartridge enclosure assembly latch element 210 are axially aligned with spring aligning pins 632 of cartridge enclosure assembly chassis 170, and both form a guiding route for springs 212
(198) It is a particular feature of an embodiment of the present invention that side protrusion 920 of cartridge enclosure assembly latch element 210 engages rearwardly facing end surfaces 638 of spring seat cut-outs 630 in this locked operative orientation and the springs 212, which are supported at one side on side protrusions 920 and on another side on forwardly facing surface from which spring aligning pins 632 extend, are pre-stressed in this locked operative orientation.
(199) It is also seen that cartridge enclosure assembly latch element 210 is seated within cartridge enclosure assembly chassis 170, such that the outwardly facing surfaces of bottom portions 872 of first and second arms 852 and 854 of cartridge enclosure assembly latch element 210 engage inwardly facing side wall portions 640 of cartridge enclosure assembly chassis 170.
(200) It is seen in
(201) The cartridge enclosure assembly chassis 170 is supported on chassis element 150, such that rearwardly facing surfaces 618 of cartridge enclosure assembly chassis 170 engage forwardly facing surfaces 514 of chassis element 150 and thus prevent any relative movement between the cartridge enclosure assembly chassis 170 and the chassis element 150.
(202) It is a particular feature of an embodiment of the present invention that cartridge enclosure assembly latch element 210 is slidably axially displaceable along longitudinal axis 105 with respect to chassis element 150. It is particularly seen that downwardly extending protrusions 510 of track arms 500 of chassis element 150 engage upwardly facing guiding track 880 formed between longitudinal ribs 882 of first and second arms 852 and 854 of cartridge enclosure assembly latch element 210, thus guiding the slidable axial displacement of the cartridge enclosure assembly latch element 210 with respect to chassis element 150.
(203) It is additionally seen in
(204) It is a particular feature of an embodiment of the present invention that plunger rod element 230 extends forwardly through cut-out 860 of cartridge enclosure assembly latch element 210.
(205) It is a further particular embodiment of the present invention that rearwardly facing surface 1017 of piston contact element 240 engages forwardly facing surface 912 of cartridge enclosure assembly latch element 210 in this locked operative orientation, when the plunger rod element 230 is positioned at its forward operative orientation.
(206) Reference is now made to
(207) It is noted that most spatial relationships between the chassis element 150, the piston drive subassembly 220 and the locking subassembly 200 remain substantially the same as described hereinabove with reference to
(208) It is seen in
(209) It is specifically seen in
(210) It is a particular feature of an embodiment of the present invention that in order to position the locking subassembly 200 in the unlocked operative orientation, the moveable subassembly 1005 of the piston drive subassembly 220 pulls the cartridge enclosure assembly latch element 210 axially rearwardly, due to activation of the electrical motor 158. The extent of rearward displacement of the plunger rod element 230 depends on pre-programmed definitions for the electrical motor 158. It is an additional particular feature of an embodiment of the present invention that the maximum extent of rearward displacement of the plunger rod element 230 is defined by engagement of anti-rotation element 242 with home position sensor 980, which serves as a safety measure that stops rearward displacement of the plunger rod element 230 in order to prevent damage to the MUCI 100.
(211) It is a particular feature of an embodiment of the present invention that in comparison to
(212) It is a further particular embodiment of the present invention that piston drive subassembly 220 is operative for axially slidably displacing the cartridge enclosure assembly latch element 210 with respect to cartridge enclosure assembly chassis 170 due to engagement of piston contact element 240 with base wall portion 850 of cartridge enclosure assembly latch element 210. Particularly, rearwardly facing surface 1017 of piston contact element 240 is supported against forwardly facing surface 912 of cartridge enclosure assembly latch element 210, and thus upon rearward displacement of the piston drive subassembly 220 along longitudinal axis 105, piston contact element 240 displaces the cartridge enclosure assembly latch element 210 rearwardly against the force of springs 212. It is seen in
(213) Reference is now made to
(214) In
(215) As illustrated in
(216) It is appreciated that in this first pre-cartridge insertion operative orientation, the cartridge enclosure assembly 130 is disposed in its closed operative orientation, as described in detail hereinabove with reference to
(217) It is specifically seen in
(218) Display 106 is provided under the transparent window 108 of top housing portion 104, preferably configured to provide instructions and indications to the user.
(219) Button defining element 112 is seated within opening 110 of top hop housing portion and is disposed such that buttons 350, 352 and 354 are positioned just above menu button switches 964, thus configured to be operatively coupled therewith.
(220) It is seen particularly in
(221) It is a particular feature of an embodiment of the present invention that as specifically seen in
(222) It is appreciated that there is a range of axial positions of the moveable subassembly 1005. Which define the forward and rearward operative orientations thereof, in which the locking subassembly 200 is positioned in locked and unlocked operative orientations respectively.
(223) Locked operative orientation of the locking subassembly 200, which causes the cartridge enclosure assembly 130 to assume its closed operative orientation, is defined by the following spatial relationships:
(224) As specifically seen in
(225) As specifically seen in
(226) It is seen that cartridge enclosure assembly latch element 210 is positioned in this slightly rearwardly displaced positioned by means of force that is applied thereon by piston contact element 240, which is fixedly attached to plunger rod element 230, which is in turn displaced by means of the force applied thereon by the electrical motor 158. Specifically, rearwardly facing surface 1017 of piston contact element 240 engages forwardly facing surface 912 of base wall portion 850 of cartridge enclosure assembly latch element 210. Due to this engagement and the position of the moveable subassembly 1005 of the piston drive subassembly 220 in this operative orientation, side protrusions 9′20 of cartridge enclosure assembly latch element 210 are slightly spaced rearwardly from rearwardly facing end surfaces 638 of cartridge enclosure assembly chassis 170 and the springs 212 are slightly compressed.
(227) Cartridge enclosure assembly state sensor 784 is preferably disposed in a triggered state, resulting from engagement with upwardly facing protrusion 898 of protrusion 890 of cartridge enclosure assembly latch element 210, which indicates that pivot mount element 180 is disposed in its closed operative orientation.
(228) Additionally seen in
(229) It is additionally seen in
(230) It is particularly seen in
(231) Reference is now made to
(232) In
(233) As seen in
(234) The mutual orientations of the various elements described in
(235) It is seen particularly in
(236) It is a particular feature of an embodiment of the present invention that as specifically seen in
(237) Once the user pressed the button identified as “OPEN” on the display 106 and confirmed his selection, signal was provided to the system to activate the electrical motor 158, such that the moveable subassembly 1005 of the piston drive subassembly 220 is retracted rearwardly along longitudinal axis 105 to a pre-determined longitudinal extent, which positions the locking subassembly 200 in its unlocked operative orientation. During the rearward displacement of the moveable subassembly 1005, it pulls cartridge enclosure assembly latch element 210 rearwardly and thus urging the locking subassembly 200 to its unlocked operative orientation.
(238) The unlocked operative orientation of the locking subassembly 200, which subsequently enables the cartridge enclosure assembly 130 to assume its open operative orientation, is defined by the following spatial relationships:
(239) As specifically seen in
(240) As specifically seen in
(241) It is seen that cartridge enclosure assembly latch element 210 is positioned in this fully rearwardly displaced positioned by means of force that is applied thereon by piston contact element 240, which is fixedly attached to plunger rod element 230. Specifically, rearwardly facing surface 1017 of piston contact element 240 engages forwardly facing surface 912 of base wall portion 850 of cartridge enclosure assembly latch element 210. Due to this engagement and the position of the moveable subassembly 1005 in this operative orientation, side protrusions 920 of cartridge enclosure assembly latch element 210 are fully spaced rearwardly from rearwardly facing end surfaces 638 of cartridge enclosure assembly chassis 170 and the springs 212 are fully compressed.
(242) Cartridge enclosure assembly state sensor 784 is preferably disposed in an untriggered state, resulting from disengagement with upwardly facing protrusion 898 of protrusion 890 of cartridge enclosure assembly latch element 210, which indicates that pivot mount element 180 is disposed in its open operative orientation.
(243) Additionally seen in
(244) Reference is now made to
(245) In
(246) As seen in
(247) The mutual orientations of the various elements described in
(248) It is seen particularly in
(249) Following the unlocking of the locking subassembly 200, as described in particular hereinabove with reference to
(250) Reference is now made to
(251) It is seen in
(252) In
(253) As seen in
(254) The mutual orientations of the various elements described in
(255) During the forward displacement of the plunger rod element 230, the cartridge enclosure assembly latch element 210 is permitted to be displaced forwardly to the same longitudinal extent as the moveable subassembly 1005, under the biasing force of springs 212.
(256) The locking subassembly 200 is still disposed in the unlocked operative orientation, and the pivot mount element 180 is still disposed in the open operative orientation however the cut-out 892 formed between upper portion 870 and bottom portion 872 of first and second arms 852, 854 of cartridge enclosure assembly latch element 210 is now less rearwardly spaced from locking snap elements 722 of pivot mount element 180.
(257) As specifically seen in
(258) Due to forward displacement of the moveable subassembly 1005 of the piston drive subassembly 1005 in this operative orientation, side protrusions 920 of cartridge enclosure assembly latch element 210 are less spaced rearwardly from rearwardly facing end surfaces 638 of cartridge enclosure assembly chassis 170 and the springs 212 are less compressed.
(259) It is specifically seen in
(260) Reference is now made to
(261) In
(262) As seen in
(263) It is particularly seen in
(264) Reference is now made to
(265) In
(266) The mutual orientations of the various elements described in
(267) It is particularly seen in
(268) Reference is now made to
(269) In
(270) It is noted that
(271) It is seen specifically in
(272) The mutual orientations of the various elements described in
(273) The medicament cartridge 1100 is inserted into the inner volume 550 of pivot mount element 180.
(274) It is seen particularly in
(275) It is appreciated that there is a range of axial positions of the cartridge enclosure assembly latch element 210, which defines the snapped operative orientation of locking subassembly 200.
(276) Pivot mount element 180 is pivoted relative to cartridge enclosure assembly chassis 170 to assume the closed operative orientation against the urging of torsion springs 182.
(277) It is seen that rearwardly facing surface 1017 of piston contact element 240 does not engage forwardly facing surface 912 of base wall portion 850 of cartridge enclosure assembly latch element 210.
(278) It is specifically seen in
(279) As specifically seen in
(280) Cartridge enclosure assembly state sensor 784 is preferably disposed in untriggered state, resulting from disengagement with upwardly facing protrusion 898 of protrusion 890 of cartridge enclosure assembly latch element 210, which indicates that pivot mount element 180 is disposed in its open operative orientation.
(281) Reference is now made to
(282) It is seen specifically in
(283) The mutual orientations of the various elements described in
(284) It is seen particularly in
(285) It is specifically seen in
(286) As specifically seen in
(287) Reference is now made to
(288) It is seen specifically in
(289) The mutual orientations of the various elements described in
(290) It is seen particularly in
(291) It is specifically seen in
(292) As specifically seen in
(293) Reference is now made to
(294) It is seen specifically in
(295) The mutual orientations of the various elements described in
(296) It is seen particularly in
(297) It is specifically seen in
(298) As specifically seen in
(299) Reference is now made to
(300) It is seen specifically in
(301) The mutual orientations of the various elements described in
(302) It is seen particularly in
(303) It is seen that rearwardly facing surface 1017 of piston contact element 240 now engages forwardly facing surface 912 of base wall portion 850 of cartridge enclosure assembly latch element 210 and the springs 212 are less compressed now.
(304) The rearward end of medicament cartridge 1100 does not engage arc-shaped protrusion 910 of cartridge enclosure assembly latch element 210.
(305) It is specifically seen in
(306) It is seen in
(307) As specifically seen in
(308) Cartridge enclosure assembly state sensor 784 is now disposed in triggered state, resulting from engagement with upwardly facing protrusion 898 of protrusion 890 of cartridge enclosure assembly latch element 210, which indicates that pivot mount element 180 is now positioned in its closed operative orientation.
(309) Reference is now made to
(310) It is appreciated that in this sixth stage of the second cartridge insertion operative orientation, the cartridge enclosure assembly 130 is disposed in its closed operative orientation and the moveable subassembly 1005 of the piston drive subassembly 220 is displaced axially forwardly along longitudinal axis 105 as compared to
(311) The mutual orientations of the various elements described in
(312) It is seen particularly in
(313) Pivot mount element 180 is positioned in the closed operative orientation in this sixth stage of the second cartridge insertion operative orientation.
(314) It is seen that rearwardly facing surface 1017 of piston contact element 240 engages forwardly facing surface 912 of base wall portion 850 of cartridge enclosure assembly latch element 210 and the springs 212 are less compressed as compared to
(315) The rearward end of medicament cartridge 1100 now nearly engages arc-shaped protrusion 910 of cartridge enclosure assembly latch element 210.
(316) It is specifically seen in
(317) As specifically seen in
(318) Cartridge enclosure assembly state sensor 784 is disposed in triggered state, resulting from engagement with upwardly facing protrusion 898 of protrusion 890 of cartridge enclosure assembly latch element 210, which indicates that the pivot mount element 180 is disposed in its closed operative orientation.
(319) It is additionally seen in
(320) It is additionally seen in
(321) It is particularly seen in
(322) It is specifically seen in
(323) The inactivated forward operative orientation of needle presence responsive element 190 is defined by the following spatial relationships:
(324) The rearwardly facing surface 803 of flat wall portion 800 of needle presence responsive element 190 supports one end of springs 192 and is forwardly spaced from forwardly facing edge 766 of pivot mount element 180, which supports the other end of springs 192. Springs 192 are pre-loaded in this operative orientation and urge the needle presence responsive element 190 to extend forwardly.
(325) Forwardly facing shoulder surfaces 822 and 826 of snap protrusions 804 and 806 of needle presence responsive element 190 engage rearwardly facing shoulder surfaces 734 of pivot mount element 180, which prevent detachment of the needle presence responsive element 190 from pivot mount element 180.
(326) Reference is now made to
(327) It is seen in
(328) Reference is now made to
(329) In
(330) The display 106 instructs the user to orient the injector with needle pointing up.
(331) The user can visually inspect the contents of medicament cartridge 1100 through transparent window 564, which forms part of pivot mount element 180.
(332) As seen in
(333) The mutual orientations of the various elements described in
(334) It is particularly seen in
(335) It is specifically seen in
(336) It is specifically seen in
(337) The activated rearward operative orientation of needle presence responsive element 190 is defined by the following spatial relationships:
(338) The rearwardly facing surface 803 of flat wall portion 800 of needle presence responsive element 190 is now less forwardly spaced from forwardly facing edge 766 of pivot mount element 180. Springs 192 are compressed in this operative orientation.
(339) Forwardly facing shoulder surfaces 822 and 826 of snap protrusions 804 and 806 of needle presence responsive element 190 disengage and are now rearwardly spaced from rearwardly facing shoulder surfaces 734 of pivot mount element 180.
(340) It is also seen in
(341) It is a particular feature of an embodiment of the present invention that as particularly seen in
(342) Reference is now made to
(343) It is a particular feature of an embodiment of the present invention, as described hereinabove with reference to
(344) It is seen in
(345) It is a particular feature of an embodiment of the present invention that once the user orients the MUCI 100 with the needle 1152 pointing up and press button 352 identified on the display as “OK”, the display 106 is preferably shifted by 180 degrees and instructs the user to press the button which is identified as “PRIME” on the display 106 until drops appear at the tip of needle 1152, as clearly seen in
(346) It is particularly seen in
(347) It is seen in
(348) It is noted that once the user observes a drop of medicament 1106 at the top of needle 1152, he stops pressing the button identified as “PRIME” on the display 106.
(349) It is particularly seen in
(350) It is appreciated that the priming process preferably continues as long as the user presses button 350, which is identified as “PRIME” on the display. Alternatively, the control system can define a condition where the priming process will be stopped even if the user did not release the button indicated as “PRIME” on the screen. This condition may include a certain amount of medicament 1106 ejected from the medicament cartridge 1100 or a predetermined pressure threshold exerted on the piston contact element 240.
(351) As seen in
(352) It is a particular feature of an embodiment of the present invention that the initiation of injection is permitted only after the priming process is completed in order to enable the control system of the MUCI 100 to identify the exact amount of medication ejected from the medicament cartridge 1100. This exact identification is provided by the fact that the injection is initiated only when the priming process is completed. The user indicates to the control system that the priming was completed by pressing button 354, which is identified as “DONE” on display 106 as seen in
(353) It is appreciated that in accordance with an embodiment of the present invention, confirmation of completion of the priming process by the user, or alternatively, automatic check of priming completion by the control system, can be defined as a condition for initiating injection. Such automatic check of priming completion may include identification of change in resistance to operate the electric motor 158, thus indicating that the piston contact element 240 engaged the piston 1104 within the medicament cartridge 1100.
(354) The mutual orientations of the various elements described in
(355) Piston contact element 240 is now supported between the piston 1104 and the cartridge enclosure assembly latch element 210, such that the forward facing surface 1016 of piston contact element 240 engages the piston 1104 and the rearward facing surface 1017 of piston contact element 240 engages the forwardly facing surface 912 of cartridge enclosure assembly latch element 210, thus the MUCI 100 is now ready for injection upon receiving the appropriate signal from the control system, as described further hereinbelow.
(356) The rearward edge of medicament cartridge 1100 engages arc-shaped protrusion 910 of the cartridge enclosure assembly latch element 210 in order to support and align the medicament cartridge 1100.
(357) It is noted that the moveable subassembly 1005 of the piston drive subassembly 220 is now displaced slightly forwardly with respect to the position thereof as shown in
(358) Reference is now made to
(359) It is seen in
(360) It is seen in
(361) Reference is now made to
(362) It is seen in
(363) The mutual orientations of the various elements described in
(364) It is seen in
(365) It is seen in
(366) Reference is now made to
(367) It is seen in
(368) It is seen in
(369) It is seen that in
(370) In this injection operative orientation, it is seen that the cartridge enclosure assembly latch element 210 engages the medicament cartridge 1100 and the moveable subassembly 1005 of piston drive subassembly 220 is displaced forwardly along longitudinal axis 105, while driving the piston contact element 240 forwardly away from arc shaped protrusion 910 of the cartridge enclosure assembly latch element 210.
(371) It is seen in
(372) It is seen that in
(373)
(374) It is seen in
(375) Reference is now made to
(376) It is seen in
(377) It is seen in
(378) It is seen in
(379) It is further seen in
(380) In
(381) It is noted that the MUCI 100 as shown in
(382) It is a particular feature of an embodiment of the present invention that the MUCI 100 optionally includes a manually operable opener for the pivot mount element 180, which is operative to permit opening of the pivot mount element 180 under low-battery conditions. The electrical motor 158 is operative under low-battery conditions to operate the cartridge enclosure assembly latch element 210, such as to displace it longitudinally rearwardly, so as to enable opening of the pivot mount element 180 by the manually operable opener.
(383) It is a further particular feature of an embodiment of the present invention that the medicament cartridge 1100, which is cylindrical and circularly symmetric, optionally bears an RFID transducer fixed thereto and containing information relating to the medicament. The MUCI 100 further has and an RFID communication antenna disposed within the main housing portion 102 and top housing portion 104 for communicating with the RFID transducer on the medicament cartridge 1100. The RFID communication antenna is operative to communicate with the RFID transducer irrespective of the rotational orientation of the medicament cartridge 1100 within the cartridge enclosure assembly 130. The RFID communication antenna is optionally a V-shaped antenna. The MUCI 100 may be operated at least partially based on information received from the RFID transducer.
(384) It is a yet further particular feature of an embodiment of the present invention that optionally initiation of medicament injection is enabled only upon an indication related to at least partial performance of priming function.
(385) Reference is now made to
(386) Preferably, as shown in step 2000, when no cartridge is installed in the MUCI 100, such as out of the box or after previous use and removal of cartridge, the screen is blank and LEDs are not illuminated, as shown in step 2002 until the user presses on middle (on/off) button as seen in step 2004 and the MUCI 100 performs various checks (at outset and optionally throughout procedure), which are described hereinbelow in steps 2006 to 2022 and accordingly instructs the user.
(387) Specifically, as shown in step 2006, the MUCI 100 checks whether the pivot mount element 180 is not unlatched, the needle 1152 is attached and medicament cartridge 1100 is not present. If all of the above conditions are fulfilled, then the display 1006 instructs the user to detach the needle 1152, as shown in step 2008.
(388) Further, as shown in step 2010, the MUCI 100 checks whether the pivot mount element 180 is unlatched. Notwithstanding whether the needle 1152 is attached or whether the medicament cartridge 1100 is present, the display 1006 instructs the user to load medicament cartridge 1100 and close the pivot mount element 180, as shown in step 2012.
(389) Yet further, as shown in step 2014, the MUCI 100 checks whether the pivot mount element 180 is not unlatched, the needle 1152 is not attached and medicament cartridge 1100 is present. If all of the above conditions are fulfilled, then the display 1006 instructs the user to attach needle 1152, as shown in step 2016.
(390) Still further, as shown in step 2018, the MUCI 100 checks whether the pivot mount element 180 is not unlatched, the needle 1152 is attached and medicament cartridge 1100 is present. If all of the above conditions are fulfilled, then the display 1006 instructs the user to inject, as shown in step 2020.
(391) Further specifically, as shown in step 2022, the MUCI 100 checks whether the pivot mount element 180 is not unlatched, the needle 1152 is not attached and medicament cartridge 1100 is not present. If all of the above conditions are fulfilled, then the status of the MUCI 100 is optionally shared with a remote server by wireless communication, as shown in step 2024 and the display 1006 instructs the user to open and load medicament cartridge 1100, as shown in step 2026.
(392) Further, as shown in step 2028, the user presses button 354 identified on display 1006 as open and thereafter, as shown in step 2030, the user confirms by pressing button 350 identified on screen as “YES”, which button is on opposite side of injector from button 354, pressed previously as shown in step 2028.
(393) Following the pressing on button 350, the electrical motor 158 is operated rearwards x steps to retract moveable subassembly 1005, including the plunger rod element 230, by y mm (optionally using encoder either on the electrical motor or on motor-driven plunger rod element), and the moveable subassembly 1005 in turn operates a cartridge enclosure assembly latch element 210, thus opening the pivot mount element 180 for medicament cartridge 1100 insertion, as shown in step 2032.
(394) Once the pivot mount element 180 is opened, the following occurs:
(395) Cartridge enclosure assembly state sensor 784 indicates that the pivot mount element 180 is open, as shown in step 2034; The display 1006 instructs the user to insert medicament cartridge and close pivot mount element 180, as shown in step 2036; and the electrical motor 158 is operated forward z steps to reset cartridge enclosure assembly latch element to be ready to engage and retain the pivot mount element 180 when it is pressed and clicked by the user, as shown in step 2038.
(396) Further, as shown in step 2040, the user inserts the medicament cartridge 1100 into injector and closes the pivot mount element 180, as shown in step 2040.
(397) Following the insertion of the medicament cartridge 1100 by the user, the MUCI 100 optionally checks temperature of medicament in the medicament cartridge 1100 and if temperature is not within acceptable range, the MUCI 100 displays screen warning the user and could also prevent injection—further option—could warm the medicament which is too cold, as shown in step 2042 and then the display 106 instructs the user to attach needle 1152, as shown in step 2044. If one of the above conditions is not fulfilled, then the MUCI 100 instructs the user according to
(398) Following step 2044, the electrical motor 158 is operated forward q steps to fully lock medicament cartridge assembly latch element 210, as shown in step 2046 and the MUCI 100 marks that priming is required, as shown in step 2048.
(399) It is further seen in step 2052, that the user now should attach the needle 1152. If the user does not attach needle 1152, then the display 106 proceeds indicating to the user to attach needle 1552 or goes into sleep mode after a predetermined amount of time, as shown in step 2054. If the user attaches the needle 1152, then the needle sensor 782 indicates “YES”, as shown in step 2056, and the MUCI 100 performs the checks according to steps 2006-2022 and if pivot mount element 180 is latched and needle 1152 is attached and medicament cartridge 1100 is present, as shown in step 2058, then the MUCI proceeds to step 2060, which is detailed further hereinbelow. If one of the above conditions is not fulfilled, then the MUCI 100 instructs the user according to
(400) It is shown in step 2060 that the MUCI 100 initiates priming activity in two different cases. The first one is shown in step 2062, when priming was not earlier performed. The second one is shown in step 2064 when priming was earlier performed but the user nevertheless initiates priming by pressing “priming” button indicated on a menu screen.
(401) Preferably, there are at least two alternatives for performing the priming process. In accordance with a first alternative, it is shown in step 2066 that the display 106 instructs user to orient the MUCI 100 with needle 1152 pointing up. Further, the user orients the MUCI 100 with needle 1152 pointing up as shown in step 2068. Further, the user may press button identified on display 106 as “OK”, to confirm that the MUCI 100 is oriented with needle 1152 pointing up, as shown in step 2070 or if the user does not press button as in step 2070 within 30 seconds, the MUCI 100 proceeds as if user had pressed the button, as shown in step 2072.
(402) Further, display 106 shows that the MUCI 100, which is oriented with needle 1152 up, is ready for priming, by shifting the display 106 by 180 degrees as shown in step 2074.
(403) Following step 2074, the user taps the MUCI 100 to dislodge air bubbles 1160 in the medicament cartridge 1100 and then presses button identified on the display 106 as “PRIME” and as long as the user continues pressing, the electrical motor 158 is operated to move the moveable subassembly 1005 upward in the medicament cartridge 1100, as shown in step 2076.
(404) Once the user sees a drop of liquid at top of needle 1152, user stops pressing the prime button as shown in step 2078. If user still sees air bubbles 1160 in the medicament cartridge 1100, user repeats steps 2076 and 2078 until no air bubbles 1160 remain in the medicament cartridge 1100.
(405) Further, it is shown in step 2080 that the user presses a different button identified on the display 106 as “DONE” in order to confirm that no air bubbles 1160 remain in the medicament cartridge 1100 and thus priming is completed, thus the display 106 instructs the user to inject and the display 106 shifts back by 180 degrees, as shown in step 2082.
(406) In accordance with a second alternative, it is shown in step 2090 that the display 106 instructs the user to orient the MUCI 100 with needle pointing up. Further, the user orients the MUCI 100 with needle 1152 pointing up as shown in step 2092 and accelerometer (not shown) in the MUCI 100 confirms that the MUCI 100 is oriented with needle 1152 pointing up, following which the display 106 shows that the MUCI 100 oriented with needle 1152 up is ready for priming, by shifting the display 106 by 180 degrees, as shown in steps 2094 and 2096.
(407) It is further shown in step 2098 that the electrical motor 158 is operated back and forth to create vibration for x seconds to dislodge air bubbles 1160 towards needle 1152. Preferably, as further shown in step 2100, the user presses button identified on display 106 as “AUTOPRIME” causing the electrical motor 158 to move the moveable subassembly 1005 upward in the medicament cartridge 1100 until the piston contact element 240 engages the piston 1104 and thereafter for a distance of y mm.
(408) As is seen in step 2102, the user now checks to see if any air bubbles 1160 remain in the medicament cartridge. If so, user taps the MUCI 100 to dislodge air bubbles 1160 in the medicament cartridge 1100 and this tapping may be sensed by the accelerometer or by a different accelerometer. Further, the user presses button identified on the display 106 as “PRIME” and as long as user continues pressing, the electrical motor 158 is operated to move the moveable subassembly 105 upward in the medicament cartridge 1100. If air bubbles 1160 are still present in the medicament cartridge 1100, user repeats steps 2100 and 2102 until no air bubbles 1160 remain in the medicament cartridge 1100.
(409) Further seen in step 2104 that once the user sees a drop of liquid at top of needle 1152, the user stops pressing the prime button. Once user confirms that no air bubbles 1160 remain in the medicament cartridge 1100, user presses different button identified on display 106 as “DONE” in order to confirm that priming is completed, as shown in step 2106. Further, the display 106 instructs the user to inject and the display 106 is shifted back by 180 degrees, as shown in step 2108.
(410) Following the completion of the priming procedure, the user sets dose and injection duration, as shown in step 2110. The setting of dose and injection duration preferably includes the steps which are detailed hereinbelow in steps 2112-2126.
(411) As shown in step 2112, the user presses button 350 identified on display 106 as “MENU” and selects “INJECTION DOSE” by scrolling with menu buttons up & down as shown in step 2114 and then presses buttons 350/354, that are identified as up and down on display 106 to select the dosage, which appears on the display 106 along with an indication of amount of medicament remaining in medicament cartridge 1100, as shown in step 2116.
(412) Once the user sees the appropriate dose on the display 106, user presses button 352 identified as “SAVE” on display 106 to enter and save the selected dosage until it is changed, as shown in step 2118.
(413) Step 2120 show that display 106 appears which enables selection of injection duration, then the user presses buttons 350/354 identified as up and down on display 106 to select the injection duration, which appears on the screen, as shown in step 2122.
(414) It is a particular feature of an embodiment of the present invention as is shown in step 2124 that the MUCI 100 does not permit the user to select an injection duration which is too short, the display 106 shows the shortest allowed injection duration for the selected dosage. This function allows controlling the injection speed and preventing setting of injection speed above a pre-determined threshold, which could be harmful for the user.
(415) Once the user sees the appropriate injection duration on the display 106, user presses button 352 identified as “SAVE” on display 106 to enter the selected injection duration, as shown in step 2126.
(416) Once the setting stage is completed, the user preferably inserts the needle 1152 at an injection site on a body up to the hilt and then presses injection button element 120 preferably with his thumb, as shown in step 2128. Pressing the injection button element 120 produces two results: the display 106 shows a countdown of the duration of injection, preferably along with an audible indication and a visual indication, such as LEDs illuminating around the injection button element 120, as shown in step 2130 and the electrical motor 158 advances the moveable subassembly 1005 by a distance which precisely corresponds to the selected dose and at a rate which precisely corresponds to the selected injection duration, as shown in step 2132.
(417) Preferably, the display 106 then shows a “DONE” message and indicates the quantity of medicament injected as well as a button identification for user to indicate “OK”, as shown in step 2134 and the MUCI 100 also provides an audible indication at the end of injection process. It is shown in step 2136 that the MUCI 100 stores all relevant information regarding the injection including: date, time, dose, duration, medicament id. The MUCI 100 may optionally transmit all such information wirelessly to a remote server, as shown in step 2138.
(418) Following injection completion, the user preferably presses button 352, identified as “OK” on the display 106, as shown in step 2140, then the display 106 instructs the user to detach and dispose of needle 1152 and displays a button identified as “OK”, as shown in step 2142.
(419) At this stage, the user has two alternatives to choose from: the first alternative is shown in step 2144, when the user detaches needle 1152, which is sensed by needle sensor 782; the second alternative is shown in step 2146, when the user presses button 352 indicated on screen as “OK” to indicate that he intends to reuse needle 1152.
(420) It is appreciated that at this stage the MUCI 100 is ready for an additional injection.
(421) It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the present invention includes both combinations and subcombinations of various features described herein and improvements and variations which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.