AUTO INJECTOR AND CASSETTE SYSTEM WITH INDEX RING IN THE CASSETTE
20240316276 ยท 2024-09-26
Inventors
- Ole LEMMING (Holstebro, DK)
- Peter Lundholm Jensen (Copenhagen, DK)
- Thorben Kvisgaard Jacobsen (Graested, DK)
- Peter Blaabjerg JACOBSEN (Struer, DK)
Cpc classification
A61M2005/3267
HUMAN NECESSITIES
A61M5/31565
HUMAN NECESSITIES
A61M2205/13
HUMAN NECESSITIES
A61M5/204
HUMAN NECESSITIES
A61M2005/208
HUMAN NECESSITIES
A61M5/2422
HUMAN NECESSITIES
A61M5/3204
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
Abstract
The invention relates to a system comprising a cassette and an auto injector for delivery of medicament. The cassette for containing the medicament comprises an index ring.
Claims
1. A cassette for use in an auto injector for administering a medicament, the cassette extending in a longitudinal direction (L) from a proximal end (102) to a distal end (104), the cassette (100) comprising: a syringe holder (300) for receiving a syringe (200) containing the medicament; a skin sensor (400) longitudinally movable relative to the syringe holder (300) between a plurality of longitudinal positions including at least: a proximal longitudinal position (LP); and a distal longitudinal position (LD); an index ring (500) rotatable relative to the skin sensor (400) between a plurality of rotational positions including at least: a first rotational position (R1) in which the skin sensor (400) is prevented from moving distally; and a second rotational position (R2) in which the skin sensor (400) is moveable between the distal longitudinal position and the proximal longitudinal position (LP); wherein the rotational position of the index ring (500) is configured to be controlled by one or more release members (1006) in the auto injector when the cassette (100) is secured in the auto injector (1000).
2. The cassette according to any preceding claim, wherein when the skin sensor (400) is in the proximal longitudinal position (LP), and the index ring is in the first rotational position, the skin sensor (400) is prevented from moving distally from the proximal longitudinal position (LP) by the index ring.
3. The cassette according to any preceding claim, wherein prior to use, the index ring is in the first rotational position (R1) and the skin sensor (400) is locked relative to the syringe holder (300) in an initial locked position (LP1).
4. The cassette according to any preceding claim, wherein when the index ring (500) is in the second rotational position (R2), the skin sensor (400) is longitudinally movable relative to the index ring (500).
5. The cassette according to any preceding claim, wherein when the index ring is in the second rotational position (R2), the skin sensor (400) is unlocked and able to move relative to the syringe holder (300) in a proximal direction and/or a distal direction.
6. The cassette according to any preceding claim, wherein the index ring comprises a tubular index ring part (520) extending around a tubular skin sensor part (420).
7. The cassette according to any preceding claim, wherein the index ring comprises a tubular index ring part (520) extending around the syringe holder (300).
8. The cassette according to any preceding claim, wherein the skin sensor (400) comprises a protruding tab (408) on an outer surface of the skin sensor (400), and the index ring (500) comprises a first longitudinally extending part (506) with a first recess (508, 508) in which the protruding tab (408) is confined prior to use.
9. The cassette according to any preceding claim, wherein the index ring (500) comprises a locking tab (507), and the skin sensor (400) comprises a first locking recess (412) in which locking tab (507) is confined prior to use.
10. The cassette according to any preceding claim, wherein the index ring (500) is configured for moving between the plurality of rotational positions when the cassette (100) is inserted in the auto injector (1000) and a release member (1006) comprised in the auto injector travels proximally into in the cassette (100) and comes in contact with the index ring (500).
11. The cassette according to any preceding claim, wherein the index ring comprises a track (530) extending from a first corner (532) to a second corner (534), wherein the index ring (500) is configured for rotating from the first rotational position (R1) to the second rotational position (R2) when the cassette (100) is inserted in the auto injector (1000) and a release member (1006) comprised in the auto injector travels proximally inside the track (530).
12. The cassette according to claim 11 wherein the index ring comprises a first radially extending part (522) having a first surface area (528) extending between a first proximal surface (524) and a first distal surface (526), wherein the track (530) is positioned on the surface area (528).
13. The cassette according to claim 11, wherein the track (530) is positioned on the first longitudinally extending part (506).
14. The cassette according to any of the claims 11-13, wherein the index ring is configured for rotating to the first rotational position when the release member (1006) comprised in the auto injector travels distally inside the track (530).
15. The cassette according to any of the claims 12-14, wherein the first radially extending part (522) is part of the tubular index ring part (520).
16. The cassette according to any of the claims 11-15, wherein the track (530) extends from the first corner (532) in an angled direction towards the second corner (534), wherein the angled directions is between 20 and 70 degrees, such as between 30 and 60 degrees, such as between 35 and 55 degrees, such as between 40 and 50 degrees, such as approximately 45 degrees relative to the longitudinal direction of the cassette.
17. The cassette according to claim 16, wherein the track (530) comprises a first track section (536), a second track section (538) and a third track section (540), wherein: the first track section (536) extends from the first corner (532) in a first angled direction towards a first middle point (542); the second track section (538) extends from the first middle point (542) to a second middle point (544) along the longitudinal direction of the cassette in a second angle direction; the third track section (540) extends from the second middle point (544) in a third angled direction towards the second corner (534), wherein the first and/or third angled directions are between 20 and 70 degrees, such as between 30 and 60 degrees, such as between 35 and 55 degrees, such as between 40 and 50 degrees, such as approximately 45 degrees relative to the longitudinal direction of the cassette, and wherein the second angled directions is between-20 and 20 degrees, such as between-10 and 10 degrees, such as approximately 0 degrees relative to the longitudinal direction of the cassette.
18. The cassette according to any preceding claim, wherein prior to use, the skin sensor (400) is locked in a initial locked position (LP1), and after use, the skin sensor is in a final locked position (LP3), wherein the initial locked position (LP1) is positioned between the final locked position (LP3) and the distal longitudinal position (LD).
19. The cassette according to any preceding claim, wherein the skin sensor (400) comprises a protruding tab (408) on an outer surface of the skin sensor (400), and the index ring (500) comprises a first longitudinally extending part (506) with a first recess (508, 508) in which the protruding tab (408) is confined prior to use.
20. The cassette according to any preceding claim, wherein the index ring (500) comprises a locking tab (507), and the skin sensor (400) comprises a first locking recess (412) in which locking tab (507) is confined prior to use.
21. The cassette according to any of the claims 19-20, wherein the first longitudinally extending part (506) extends proximally from the first proximal surface (524) on the first radially extending part (522).
22. The cassette according to any of the claims 19-21, wherein the protruding tab (408) abuts the first proximal surface (524) when the skin sensor (400) is in the distal longitudinal position (LD) thereby preventing distal movement of the skin sensor (500) relative to the syringe holder (300).
23. The cassette according to any of the claims 20-21, wherein the skin sensor (400) comprises a second distal surface (424), wherein the second distal surface (424) abuts the second proximal surface (514) of the second radially extending part (512) when the skin sensor (500) is in the distal longitudinal position (LD) thereby preventing distal movement of the skin sensor (500) relative to the syringe holder (300).
24. The cassette according to any of the claims 19-22, wherein the index ring (500) further comprises a second radially extending part (512) having a second proximal surface (514) and a second distal surface (516, 516).
25. The cassette according to claim 24, wherein the protruding tab (408) is abutting the second proximal surface (514) when the skin sensor is in the final locked position (LP3) and the index ring (500) is in the first rotational position (R1) thereby preventing distal movement of the skin sensor relative to the syringe holder.
26. The cassette according to claim 24, wherein the distal surface (416) is abutting the second proximal surface (514) when the skin sensor is in the final locked position (LP3) and the index ring (500) is in the first rotational position (R1) thereby preventing distal movement of the skin sensor relative to the syringe holder.
27. The cassette according to any of the claims 24-26, wherein the second radially extending part (512) is connected to a proximal end of the first longitudinally extending part (506).
28. The cassette according to any of the claims 24-27, wherein the index ring (500) comprises a second longitudinally extending part (518) extending from the first proximal surface (524) of the first radially extending part (522) and connected to the second radially extending part (512) at a proximal end of the second longitudinally extending part (518).
29. The cassette according to any of the claims 18-28, wherein the index ring (500) is configured for being rotated to a cap-release rotational position (Rcr) positioned between the first rotational position (R1) and a delivery rotational position (Rd), wherein in the cap-release rotational position (Rcr), the skin sensor is movable between the distal longitudinal position (LD) and an intermediate position (LP2), wherein the intermediate position (LP2) is positioned between the final locked position (LP3) and the initial locked position (LP1).
30. The cassette according to claim 29, wherein the index ring (500) is in the cap-release rotational position (Rcr) when the track-guide protrusion (1008) comprised in the auto injector is in the second track section (538).
31. The cassette according to any of the claims 29-30, wherein when the index ring is in the cap-release rotational position (Rcr), the skin sensor (400) is prevented from moving from the intermediate position (LP2) to the final locked position (LP3).
32. The cassette according to any of the claims 29-31, wherein when the index ring is in the cap-release rotational position (Rcr) and the skin sensor (400) is in the intermediate position (LP2), the protruding tab (408) abuts the second distal surface (516, 516) on the index ring.
33. The cassette according to any of the claims 29-31, wherein when the index ring is in the cap-release rotational position (Rcr) and the skin sensor (400) is in the intermediate position (LP2), the locking tab (507) on the index ring (500) abuts a second locking tab (415) on the skin sensor (400).
34. The cassette according to any of the claims 29-33, wherein the skin sensor (400) is configured for being moved to the distal longitudinal position (LD) by a user pushing the skin sensor (400) against an injection site when the index ring is: in the cap-release rotational position (Rcr), or between the cap-release rotational position (Rcr) and the delivery rotational position (Rd), or in the delivery rotational position (Rd).
35. The cassette according to any of the claims 18-34, wherein the cassette further comprises a syringe (200) having: a syringe compartment (202) containing the medicament; an outlet (204) at a proximal end (202) of the syringe compartment; a stopper (210) positioned inside the syringe compartment, wherein the stopper is movable from a distal end (204) of the syringe compartment towards the proximal end of the syringe compartment for emptying the medicament in the syringe compartment through the outlet; wherein when the skin sensor (400) is in the final locked position (LP3) and the index ring (500) is in the first rotational position (R1), the skin sensor (400) covers the syringe outlet (204), and wherein when the skin sensor (400) is in the distal longitudinal position (LD) and the index ring (500) is in the second rotational position (R2), the syringe outlet (204) is exposed.
36. The cassette according to claim 35, wherein medicament can be delivered by an auto injector induced proximal movement of the stopper (210) inside the syringe compartment (206) when the skin sensor (400) is in the distal longitudinal position (LD) and the index ring is in the delivery rotational position (Rd).
37. The cassette according to any of the claims 29-36, wherein the first longitudinally extending part (506) comprising a second recess (510, 510) in which the protruding tab (408) is confined when the skin sensor is in the intermediate position (LP2) and the index ring is in the first rotational position (R1).
38. The cassette according to any of the claims 29-36, wherein the protruding tab (507) on the first longitudinally extending part (506) is confined in a second locking recess (414) on the skin sensor when the skin sensor is in the intermediate position (LP2) and the index ring is in the first rotational position (R1).
39. The cassette according to any preceding claim, wherein the index ring (500) is longitudinally locked relative to the syringe holder (300).
40. The cassette according to any preceding claim, wherein the skin sensor (400) and the syringe holder (300) are rotationally locked.
41. The cassette according to any preceding claim, wherein the cassette further comprises a cassette housing (600) and a removable cassette cap (700) positioned at a proximal end (602) of the cassette housing (600), wherein the cassette housing (600) at least partly encloses the syringe holder (300), the syringe (200) when positioned in the syringe holder (300), the skin sensor (400), and the index ring (500) at least prior to use.
42. The cassette according to claim 41, wherein the cassette cap (700) comprises one or more cap locking parts (706) extending distally from a proximal end (702) of the cassette cap (700), wherein prior to use, a cassette cap locking protrusion (708) on each of the one or more cap locking parts (706) is secured inside the cassette housing (600).
43. The cassette according to claim 42, wherein: the skin sensor (400) comprises a recess (406) and ramp (410) at the proximal end of the skin sensor (400), the recess (406) being positioned distally of the ramp (410); and the cassette housing (600) comprising a cap holding part (608) extending radially inwardly at the proximal end (602) of the cassette housing (600); wherein prior to removal of the cassette cap (700), an inwardly extending part (709) of the cassette cap locking protrusion (708) on each of the one or more cap locking parts (706) is secured between the recess (406) of the skin sensor and the cap holding part (608), and is further abutting the proximal protruding part (410) preventing proximal movement of the cassette cap (600).
44. The cassette according to any of the claims 42-43, wherein upon proximal movement of the skin sensor from the initial locked position (LP1) to the intermediate position (LP2), the cassette cap locking protrusions (708) are moved to a position outside the cassette housing (600), and wherein when the skin sensor is in the intermediate position (LP2), removal of the cassette cap (700) is possible.
45. The cassette according to any of the claims 41-44, wherein the syringe (200) comprises a removable needle shield (212) covering the syringe outlet (208) prior to use, and wherein the cassette cap comprises a second distally extending part (710) extending around and grapping the needle shield (212), thereby removing the needle shield (212) when the cassette cap (700) is removed from the cassette housing (600).
46. The cassette according to any of the claims 35-45, wherein the syringe outlet is a hollow needle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0164] Various examples are described hereinafter with reference to the figures. Like reference numerals refer to like elements throughout. Like elements will, thus, not be described in detail with respect to the description of each figure. It should also be noted that the figures are only intended to facilitate the description of the examples. They are not intended as an exhaustive description of the claimed invention or as a limitation on the scope of the claimed invention. In addition, an illustrated example needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular example is not necessarily limited to that example and can be practiced in any other examples even if not so illustrated, or if not so explicitly described.
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DESCRIPTION OF EXAMPLES
[0180] Exemplary examples will now be described more fully hereinafter with reference to the accompanying drawings. In this regard, the present examples may have different forms and should not be construed as being limited to the descriptions set forth herein. Accordingly, the examples are merely described below, by referring to the figures, to explain aspects. As used herein, the term and/or includes any and all combinations of one or more of the associated listed items. Expressions such as at least one of, when preceding a list of elements, modify the entire list of elements and do not modify the individual elements of the list.
[0181] In the drawings, thicknesses of a plurality of layers and areas are illustrated in an enlarged manner for clarity and ease of description thereof. When a layer, area, element, or plate is referred to as being on another layer, area, element, or plate, it may be directly on the other layer, area, element, or plate, or intervening layers, areas, elements, or plates may be present therebetween. Conversely, when a layer, area, element, or plate is referred to as being directly on another layer, area, element, or plate, there are no intervening layers, areas, elements, or plates therebetween. Further when a layer, area, element, or plate is referred to as being below another layer, area, element, or plate, it may be directly below the other layer, area, element, or plate, or intervening layers, areas, elements, or plates may be present therebetween. Conversely, when a layer, area, element, or plate is referred to as being directly below another layer, area, element, or plate, there are no intervening layers, areas, elements, or plates therebetween.
[0182] The spatially relative terms lower or bottom and upper or top, below, beneath, less, above, and the like, may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device illustrated in the drawings is turned over, elements described as being on the lower side of other elements, or below or beneath another element would then be oriented on upper sides of the other elements, or above another element. Accordingly, the illustrative term below or beneath may include both the lower and upper orientation positions, depending on the particular orientation of the figure. Similarly, if the device in one of the figures is turned over, elements described as below or beneath other elements would then be oriented above the other elements. The exemplary terms below or beneath can, therefore, encompass both an orientation of above and below, and thus the spatially relative terms may be interpreted differently depending on the orientations described.
[0183] Throughout the specification, when an element is referred to as being connected to another element, the element is directly connected to the other element, or electrically connected to the other element with one or more intervening elements interposed therebetween.
[0184] The terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting. As used herein, the singular forms a, an, and the are intended to include the plural forms, including at least one, unless the content clearly indicates otherwise. At least one is not to be construed as limiting a or an. It will be further understood that the terms comprises, comprising, includes and/or including, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
[0185] It will be understood that, although the terms first, second, third, and the like may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element. Thus, a first element discussed below could be termed a second element or a third element, and a second element and a third element may be termed likewise without departing from the teachings herein.
[0186] About or approximately as used herein is inclusive of the stated value and means within an acceptable range of deviation for the particular value as determined by one of ordinary skill in the art, considering the measurement in question and the error associated with measurement of the particular quantity (i.e., the limitations of the measurement system). For example, about may mean within one or more standard deviations, or within +30%, 20%, 10%, 5% of the stated value.
[0187] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which this invention pertains. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined in the present specification.
[0188] Exemplary examples are described herein with reference to cross track section illustrations that are schematic illustrations of idealized examples, wherein like reference numerals refer to like elements throughout the specification. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, examples described herein should not be construed as limited to the particular shapes of regions as illustrated herein but are to include deviations in shapes that result, for example, from manufacturing. For example, a region illustrated or described as flat may have rough and/or nonlinear features. Moreover, sharp angles that are illustrated may be rounded. Thus, the regions illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the precise shape of a region and are not intended to limit the scope of the present claims. Some of the parts which are not associated with the description may not be provided in order to specifically describe exemplary examples of the present disclosure.
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[0190] The syringe 200 extends from a proximal end 202 to a distal end 204. At the distal end 202 of the syringe 200 is a flange 220, which assists in securing the syringe 200 inside the cassette 100. The medicament is contained inside a syringe compartment 206, which is in fluid connection with a syringe outlet 208. Inside the syringe compartment 206 is a stopper 210, which pushes medicament out of the syringe outlet 208 when moving in the proximal direction. Normally, the stopper 210 is pushed in the proximal direction by means of a plunger rod included in an auto injector into which the cassette 100 with the syringe 200 is mounted.
[0191] In the shown examples, the syringe outlet 208 is a hollow needle attached to the syringe compartment 206. The needle 208 may be detachable to the syringe compartment by means or e.g. threaded connection or a Luer lock, or be an integral part of the syringe 200 as shown in
[0192] The syringe holder 300 extends from a proximal end 302 to a distal end 304 and is has an opening 306, 315 at both of these ends. The syringe 200 is mounted in the syringe holder 300 through the opening 315 at the distal end 304 of the syringe holder 300. When mounted in the syringe holder 300, the syringe compartment 206 is contained in a syringe holder tubular part 310 having a syringe holder tubular part inspection opening 312 through which the syringe 200 can be inspected. At the distal end 304 of the syringe holder 300 is a distal tubular ring part 314 having a larger outer diameter than that of the syringe holder tubular part 310. At the most distal end, there is a hinged syringe holder lid 330 with a lid opening 332 having a diameter, which allows passage of a plunger rod included in the auto injector there through. The syringe holder lid 330 is closed during assembly when a syringe 200 has been inserted into the cassette 100, as shown in
[0193] The cassette 100 may be fully assembled apart from the closing of the syringe holder lid 330 for easy delivery to a user. Alternatively, the syringe holder lid 330 may be opened again after transport for mounting of a syringe 200. The user may then insert the syringe 200 and close the syringe holder lid 330. Other means for securing the syringe 200 inside the syringe holder 300 may also be imagined. For example, the syringe holder lid 330 may be substituted with flexible arms, which flex inwardly to secure the syringe 200 after mounting of the same in the syringe holder 300.
[0194] The proximal opening 306 in the syringe holder 300 has a diameter, which allows the needle shield 212 to pass there through, but which prevents the syringe compartment 206 to pass there through. The proximal opening 207 has an inwardly extending support surface 308 for supporting the syringe shoulder 218.
[0195] The syringe sleeve 250 shown in
[0196] Apart for the syringe sleeve 250 and the diameter of the syringe 200, the remaining cassette parts shown in
[0197] The cassette housing 600 extends from a proximal end 602 to a distal end 604 and has an opening 606 at the distal end 602 through which the index ring 500, the skin sensor 400, and the syringe holder 300 is mounted. When the cassette 100 is assembled, the cassette housing 600 at least partly if not fully encloses the syringe holder 300, the syringe 200 when positioned in the syringe holder 300, the skin sensor 400, and the index ring 500. The syringe holder 300 will normally be longitudinally and rotationally locked to the cassette housing 600. The cassette housing 600 has an inspection opening 610 on at least one surface side allowing the user to inspect the syringe compartment 206 containing the medicament when the syringe 200 is mounted inside the cassette 100. The cassette 100 may be symmetrically constructed such that it may be mounted in an auto injector in different orientations. At the distal end of the cassette housing, cassette securing tabs 612 are positioned. These are also visible in
[0198] The cassette cap 700 is removably attached to the cassette housing 600 at the proximal end 602 of the cassette housing 600. The cassette cap 700 comprises an inner cassette cap part 714 with second distally extending part 710 in the form of a tubular cap part, which is configured for griping the needle shield 212 by means of e.g. a gripping portion 712 as shown in
[0199] Positioned around the syringe holder 300 is a skin sensor 400, which extends from a proximal end 402 to a distal end 404. At the distal end 404 of the skin sensor 400 is a distal skin contact surface 405, which rest against the skin of the patient during medicament delivery. At the proximal end 404 is also a proximal recess 406 in which the cassette cap locking protrusion 708 of the cassette cap 700 is secured prior to assembling the cassette 100 in the auto injector 1000 and initiation release of the cassette cap 700 (see
[0200] The skin sensor 400 has a tubular skin sensor part 420 from where cassette skin sensor pins 422 extends in the distal direction. The tubular skin sensor part 420 has an inspection opening 426 for inspection of the syringe 200. The skin sensor 400 is normally symmetrically with a cassette skin sensor pin 422 on both sides of the skin sensor 400 and inspection openings 426 on both sides as well.
[0201] The skin sensor 400 is rotationally locked relative to the syringe holder 300. The skin sensor 400 is movable relative to the syringe holder 300 in the longitudinal direction L. The skin sensor 400 may move relative to the syringe holder 300 between a plurality of longitudinal positions including at least a proximal longitudinal position LP and a distal longitudinal position LD. As seen in
[0202] The skin sensor 400 also has a first locking recess 412 and a second locking recess 414 for interacting and coupling with the index ring 500. Between the two locking recesses 412, 412 is a first locking tab 413 and distally of the second locking recess 414 is a second locking tab 415. The second locking tab 415 is longer than the first locking tab 413. The distally directed surface of the second locking tab 415 is referred to as the first distal surface 416. The skin sensor 400 also comprises a proximally directed surface referred to as the first proximal surface 418. The first proximal surface 418 is proximally of the first locking recess 412.
[0203] The index ring 500 extends from a proximal end 502 to a distal end 504. The index ring 500 is positioned around the syringe holder 300 and is longitudinally locked to the syringe holder 300. The index ring 500 is rotationally movable relative to the skin sensor 400/syringe holder 300 between a plurality of rotational positions including at least a first rotational position R1 in which the skin sensor 400 is prevented from moving distally, and a second rotational position R2 in which the skin sensor 400 is moveable between the distal longitudinal position LD and the proximal longitudinal position LP. The rotational positions are illustrated in
[0204] The index ring 500 has two first longitudinally extending part 506 positioned opposite each other on the index ring 500. A tubular index ring part 520 on the index ring 500 is extending around the syringe holder 300. The index ring 500 comprises a first radially extending part 522, which may be part of the first radially extending part 522 as shown most clearly in
[0205] The track 530 extends from the first corner 532 in an angled direction towards the second corner 534, wherein the angled directions is between 20 and 70 degrees, such as between 30 and 60 degrees, such as between 35 and 55 degrees, such as between 40 and 50 degrees, such as approximately 45 degrees relative to the longitudinal direction of the cassette. In the track 530m shown most clearly in
[0206] The first and/or third angled directions are normally sloping directions, with an angle between 20 and 70 degrees, such as between 30 and 60 degrees, such as between 35 and 55 degrees, such as between 40 and 50 degrees, such as approximately 45 degrees relative to the longitudinal direction of the cassette. The second track section 538 is normally a plateau track section with a second angled directions between-20 and 20 degrees, such as between ?10 and 10 degrees, such as approximately 0 degrees relative to the longitudinal direction of the cassette.
[0207] On the first longitudinally extending part 506 of the index ring 500 is a second radially extending part 512. The second radially extending part 512 forms a locking tab 507, which is configured for fitting into the two locking recesses 412, 414 on the skin sensor 400. The locking tab 507 has a second proximal surface 514 and a second distal surface 516 of the second radially extending part 512.
[0208] The position of the locking tab 507 and thereby the rotational position of the index ring 500 relative to the skin sensor 400 is controlled by one or more release members 1006 in the auto injector 1000 when the cassette 100 is secured in the auto injector 1000. More specifically, the index ring 500 is configured for rotating from the first rotational position R1 to a second rotational position R2 when the cassette 100 is inserted in the auto injector 1000 and a track-guide protrusion 1008 comprised in the auto injector travels proximally inside the track 530. When the track-guide protrusion 1008 travels distally again, the index ring 500 rotates back form the second rotational position R2 to the first rotational position R1. Thus, by retrieving the release member 1006/track-guide protrusion 1008 into the auto injector again, the index ring is rotated back to its initial position. As seen in
[0209]
[0210] The cassette 100 is removable received in the auto injector 1000 along the longitudinal direction L. Normally, the cassette 1000 will be received at the proximal end 1002 of the auto injector 1000, thereby making it a front-loaded auto injector. In
[0211] As seen most clearly in
[0212] The auto injector 1000 comprises a release member 1006, which has two release member pins 1007 with each a track-guide protrusion 1008 (see also
[0213] The release member 1006 and the plunger rod 1018 are connected to a clutch 1030, which is configured for moving between a first clutch position where the plunger rod 1018 and the one or more release members 1006 are longitudinally coupled for proximal movement together; and a second clutch position where the plunger rod 1018 is decoupled from the one or more release members 1006 allowing the plunger rod 1018 to move longitudinally while the one or more release members 1006 are longitudinally stationary. This interaction is shown and discussed in more details in
[0214] The auto injector 1000 further comprises an injector skin sensor pin 1024 and a skin sensor spring system 1026, which pushes the injector skin sensor pin 1024 proximally. When the cassette 100 is mounted in the auto injector 1000, the injector skin sensor pin 1024 will push the skin sensor 400 proximally when the skin sensor 400 is free to move proximally, and the user is not pressing the skin sensor in the distal direction simultaneously. Normally, the injector skin sensor pin 1024 will be abutting one of the cassette skin sensor pins 422 in the skin sensor 400.
[0215] Inside the auto injector 1000 is further a cassette detection pin 1080 and a cassette detection spring 1082, which detects when a cassette 100 has been mounted in the auto injector 1000 by making contact with the other cassette skin sensor pin 422 in the skin sensor 400.
[0216] As shown in
[0217] The internal injector parts also includes a drive module adapted for moving the plunger rod 1018 proximately. The drive module may be constructed in a number of manners of which the solution shown in
[0218] The auto injector 1000 further may include a processor controlling the drive module, the processor including a print circuit board (PCB) 1054. Visual indicating signals to the user may be included in the form of light emitting diodes (LEDs) 1064 possibly positioned on a PCB placeholder 1062 or similar. The LEDs are displayed via an LED window frame 1050, a light box placeholder 1058, and a light guide placeholder 1060.
[0219] The auto injector may be activated by pressing an activation button 1052 positioned on a user interface housing part 1048. Normally, a protective foil 1049 is included to protect the electronic parts inside the injector 1000. For the other internal injector parts, reference is made to the reference list.
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[0223] In
[0224] When the skin sensor 400 is pushed into the distal longitudinal position LD as shown in
[0225] After medicament delivery, the user removed the skin sensor from the skin and the injector skin sensor pin 1024 and skin sensor spring system 1026 ensures that the skin sensor is pushed first into the intermediate position LP2 as shown in
[0226]
[0227]
[0228] The differences between the 4a-i figures and the 6a-i figures are the design and form of the skin sensor 400 and the index ring 500. In
[0229]
[0230] The differences between
[0231] In
[0232]
[0233] The cap locking parts 706 and/or the cassette cap locking protrusion 708 on each of the one or more cap locking part 706 are flexible. Upon proximal movement of the skin sensor 400 from the initial locked position LP1 to the intermediate position LP2, the cap locking parts 706 and/or the cassette cap locking protrusion 708 on the locking part 706 first flex slightly radially inwards in the recess 406 of the skin sensor 400 thereby enabling the cassette cap locking protrusion locking protrusions 708 to move proximally pass the cap holding part 608. When the skin sensor 400 is moved from the initial locked position LP1 to the intermediate position LP2, the distal locking ends 708 thereby move outside the cassette housing 600 as shown in
[0234]
[0235] The clutch 1030 is positioned around the plunger rod 1018 and next to the release member 1006 such that in the first clutch position shown in
[0236] When the second rotation surface 1036 on the clutch 1030 comes in contact with the second coupling surfaces 1073 on the clutch coupling part 1071, the clutch is rotated from the first clutch position and into the second clutch position as shown in
[0237] The clutch coupling part 1071 also comprises a clutch stopping surface 1074 abutting the clutch 1030 when the clutch 1030 is in the second clutch position thereby preventing the clutch 1030 and the release members 1006 positioned distally of the clutch 1030 from moving proximally with the plunger rod 1018.
[0238] The plunger rod 1018 comprises a stopping clutch tab 1019, and a distal surface of the stopping clutch tab 1019 is abutting a proximal surface of the release members 1006 when the clutch 1030 is in the first clutch position as shown in
[0239] The clutch 1030 may be configured for moving from the first clutch position to the second clutch position when the plunger rod 1018 moves distally after medicament delivery. The clutch 1030 is in the first clutch position prior to use and normally moves to the second clutch position when the index ring 500 is also rotated to the delivery rotational position Rd by proximal movement of the one or more release members 1006.
[0240] When assembling the cassette 100 and the auto injector 1000, the cassette 100 is first loaded into the auto injector 1000. Upon loading of the cassette 100 in the auto injector 1000, cassette securing tabs 612 at the distal end 604 of the cassette housing 600 snap behind corresponding cassette securing openings 1028 in the injector housing 1040. By forward movement of the release member 1006, the cassette securing tabs 612 are prevented from deflecting and exiting the cassette securing openings 1028 in the injector housing 1040 thereby locking the cassette 100 to the auto injector 1000. As the cassette 100 is now firmly locked inside the auto injector 1000. When the cassette release member 1006 moves distally again, the cassette 100 is unlocked. The locking process is shown in
[0241]
[0242] The holder lid 330 has a substantially C-shaped lid part 336 comprising an inner surface 340. The C-shaped lid part 336 may also be referred to as an open circle or a circle with a cut-through opening 337 in the circumference. The cut-through opening 337 may span an area of at least 10%, such as at least 20%, such as at least 30% of a full circular circumference. The substantially C-shaped lid part 336 is hingedly connected to the distal end of the syringe holder tubular part 310. By hingedly connected is meant that the substantially C-shaped lid part 336 can be in at least two positions as shown in
[0243] In
[0244] In
[0245] Extending radially outward from the substantially C-shaped lid part 336 are a plurality of lid locking tabs 334. These locking tabs 334 are positioned in corresponding syringe holder lid locking openings 318 in the syringe holder tubular part 310 when the substantially C-shaped lid part 336 is in the closed position as shown in
[0246] The inner surface 340 of the substantially C-shaped lid part 336 seen most clearly in
[0247] When the syringe 200 is correctly positioned inside the syringe holder tubular part 310 as shown in
[0248] The substantially C-shaped lid part 336 also has a throughgoing channel 342 in the dividing the substantially C-shaped lid part into two lid sections. The channel 342 does not divide the C-shaped lid part 336 into two completely separate parts, but instead the two sections are connected by a bridge portion 344 also forming the hinged connecting to the distal end of the syringe holder tubular part 310. This is seen most clearly in
REFERENCES
[0249] 100 cassette [0250] 102 proximal end of the cassette [0251] 104 distal end of the cassette [0252] 200 syringe [0253] 202 proximal end of the syringe/proximal end of the syringe compartment [0254] 204 distal end of the syringe/distal end of the syringe compartment [0255] 206 syringe compartment [0256] 208 hollow needle/syringe outlet [0257] 210 stopper [0258] 212 needle shield/RNS [0259] 214 inner part of the needle shield [0260] 216 outer part of the needle shield [0261] 218 syringe flange [0262] 220 syringe shoulder [0263] 250 syringe sleeve [0264] 252 proximal end of the syringe sleeve [0265] 254 distal end of the syringe sleeve [0266] 256 syringe sleeve inward protruding support surface [0267] 258 C-shaped longitudinal mounting opening [0268] 260 distal syringe sleeve support surface [0269] 300 syringe holder [0270] 302 proximal end of the syringe holder [0271] 304 distal end of the syringe holder [0272] 306 proximal opening in the syringe holder [0273] 308 syringe support surface [0274] 310 syringe holder tubular part [0275] 312 syringe holder tubular part inspection opening [0276] 314 distal tubular ring part [0277] 315 opening in the distal end of the syringe holder [0278] 316 proximal index ring support surface [0279] 318 syringe holder lid locking opening [0280] 320 syringe securing flexible tab at the distal end of the syringe holder [0281] 322 injection release member opening [0282] 330 syringe holder lid [0283] 332 syringe holder lid opening [0284] 334 lid locking tab [0285] 336 C-shaped lid part [0286] 337 opening in the C-shaped lid part [0287] 338 support lid part [0288] 340 inner surface on the C-shaped lid part [0289] 342 C-shaped lid part channel [0290] 344 bridge portion [0291] 400 skin sensor [0292] 402 proximal end of the skin sensor [0293] 404 distal end of the skin sensor [0294] 405 distal skin contact surface of the skin sensor [0295] 406 proximal recess [0296] 408 protruding tab [0297] 410 proximal protruding ramp [0298] 412 first locking recess on the skin sensor [0299] 413 first locking tab [0300] 414 second locking recess on the skin sensor [0301] 415 second locking tab [0302] 416 first distal surface [0303] 418 first proximal surface [0304] 420 tubular skin sensor part [0305] 422 cassette skin sensor pin [0306] 424 second distal surface [0307] 426 inspection opening in the skin sensor [0308] 428 cassette housing locking protrusion [0309] 500 index ring [0310] 502 proximal end of the index ring [0311] 504 distal end of the index ring [0312] 506 first longitudinally extending part [0313] 507 locking tab [0314] 508, 508 first recess on the index ring [0315] 509 index ring ramp [0316] 510, 510 second recess on the index ring [0317] 512 second radially extending part [0318] 513 opening in the second radially extending part [0319] 514 second proximal surface of the second radially extending part [0320] 516, 516 second distal surface of the second radially extending part [0321] 518 second longitudinally extending part [0322] 520 tubular index ring part [0323] 522 first radially extending part [0324] 524 first proximal surface of the first radially extending part [0325] 526 first distal surface of the first radially extending part [0326] 528 first surface area of the first radially extending part [0327] 530 track in the first radially extending part [0328] 532 first corner of the first radially extending part [0329] 534 second corner of the first radially extending part [0330] 536 first section of the track [0331] 538 second section of the track [0332] 540 third section of the track [0333] 542 first middle point of the track [0334] 544 second middle point of the track [0335] 600 cassette housing [0336] 602 proximal end of the cassette housing [0337] 604 distal end of the cassette housing [0338] 606 opening at the distal end of the cassette housing [0339] 608 cap holding part [0340] 610 inspection opening [0341] 612 cassette securing tabs [0342] 614 skin sensor locking opening [0343] 700 cassette cap [0344] 702 proximal end of the cassette cap [0345] 704 distal end of the cassette cap [0346] 706 cap locking part [0347] 708 cassette cap track-guide protrusion/cassette cap locking protrusion [0348] 709 inwardly extending part of the cassette cap locking protrusion [0349] 710 second distally extending part/tubular cap part [0350] 712 gripping portion [0351] 714 inner cassette cap part [0352] 716 outer cassette cap part [0353] 800 cassette housing cover [0354] 1000 auto injector [0355] 1002 proximal end of the auto injector [0356] 1004 distal end of the auto injector [0357] 1006 release member [0358] 1007 release member pin [0359] 1008 track-guide protrusion [0360] 1010 release member bridge [0361] 1012 plunger rod opening [0362] 1014 threaded rod [0363] 1016 motor and threaded rod connector [0364] 1018 plunger rod [0365] 1019 stopping clutch tab [0366] 1020 first plunger rod plug part [0367] 1022 second plunger rod plug part engaging the stopper [0368] 1024 injector skin sensor pin [0369] 1026 skin sensor spring system [0370] 1028 skin sensor pin opening in the cassette abutting surface [0371] 1030 clutch [0372] 1032 clutch tab [0373] 1034 first rotation surface on the clutch tab [0374] 1036 second rotation surface on the clutch tab [0375] 1040 injector housing [0376] 1042 cassette abutting surface [0377] 1043 release member opening in the cassette abutting surface [0378] 1044 distal housing section [0379] 1046 cassette covering section [0380] 1048 first user interface housing part [0381] 1049 protective foil [0382] 1050 LED window frame [0383] 1052 activation button [0384] 1054 Print circuit board (PCB) [0385] 1055 RCT battery [0386] 1056 battery [0387] 1057 adhesive [0388] 1058 light box placeholder [0389] 1060 light guide placeholder [0390] 1062 PCB placeholder [0391] 1064 LED placeholder with an LED [0392] 1066 content management system (CMS) [0393] 1068 USB gasket [0394] 1070 proximal chassis part [0395] 1071 clutch coupling part [0396] 1072 first coupling surface on the clutch coupling part [0397] 1073 second coupling surface on the clutch coupling part [0398] 1074 clutch stopping surface on the clutch coupling part [0399] 1076 motor [0400] 1077 motor flange [0401] 1078 motor gear [0402] 1079 screw [0403] 1080 cassette detection pin [0404] 1081 cassette detection pin opening in the cassette abutting surface [0405] 1082 cassette detection spring [0406] 1084 cassette detect holder [0407] 1086 cassette locking tab in the injector housing [0408] 1088 NFC antenna for detection of the RFID chip on the cassette [0409] 1090 distal end part connecting to the housing [0410] 1092 bearing [0411] 1094 middle chassis part [0412] 1095 distal chassis part [0413] L longitudinal direction [0414] LD distal longitudinal position/delivery position [0415] LP proximal longitudinal position [0416] LP1 initial locked position [0417] LP2 intermediate position/ready-to-remove-cap position [0418] LP3 final locked position [0419] R1 first rotational position/locking rotational position [0420] R2 second rotational position [0421] Rcr cap-release rotational position [0422] Rd delivery rotational position