Medical packaging sleeve having a tamper-evident cap and a mounting securing mechanism for sterile use

Abstract

Medical packaging sleeve having a tamper-evident cap for sterile use consisting of an approximately cylindrical sleeve body which is open on one side and the opening of which can be tightly sealed by a sealing stopper, wherein the position of the sealing stopper can be fixed with an approximately sleeve-shaped tamper-evident cap which extends over the sealing stopper, wherein the tamper-evident cap can be snapped onto the sleeve body, wherein the sealing stopper can be screwed into the opening of the sleeve body with a threaded screw connection, and there is a visual inspection to check the sealed rotational position between the sealing stopper and the sleeve body, wherein the tamper-evident cap is non-rotatably connected to the sealing stopper and can be engaged with the sleeve body only in the sealed rotational position of the sealing stopper.

Claims

1. A medical packaging sleeve comprising: an approximately cylindrical sleeve body having an open end; a sealing stopper attachable to the open end of the sleeve body via a threaded screw connection to provide a tight seal therebetween; a sleeve-shaped tamper-evident cap that extends over the sealing stopper for sterile use, wherein a position of the sealing stopper is fixable by the tamper-evident cap when the tamper evident cap is engaged with the sleeve body; and a marking symbol on an outer circumference of each of the sealing stopper and the sleeve body that provide a visual indication of a sealed rotational position between the sealing stopper and the sleeve body; wherein the tamper-evident cap is non-rotatably connected to the sealing stopper and engageable with the sleeve body only in the sealed rotational position of the sealing stopper.

2. The packaging sleeve of claim 1, wherein the sealed rotational position between the sealing stopper and the sleeve body further comprises a haptically perceptible latching position.

3. The packaging sleeve of claim 2, wherein the haptically perceptible latching position comprises a latching recess on the sealing stopper and a latching groove on the sleeve body.

4. The packaging sleeve of claim 1, wherein at least one axially projecting centering lug is disposed on a lower sleeve part of the tamper-evident cap and alignable with an upwardly open latching groove disposed on a periphery of the packaging sleeve.

5. The packaging sleeve of claim 4, wherein the lower sleeve part of the tamper-evident cap is configured as a radially elastically expandable latching collar comprising inclined inlet bevels.

6. The packaging sleeve of claim 5, wherein the latching collar can be snapped on over an annular collar of the sleeve body in a radially expandable manner.

7. The packaging sleeve of claim 1, wherein the tamper-evident cap can be pushed onto the sleeve body only when the sealing stopper is in the sealed rotational position on the sleeve body.

8. The packaging sleeve of claim 1, wherein a multiple seal is present between the sealing stopper and the sleeve body of the packaging sleeve.

9. The packaging sleeve of claim 8, wherein the multiple seal comprises elastomeric sealing lips on the sealing stopper that engage an inner annular surface adjacent the open end of the sleeve body.

10. The packaging sleeve of claim 1, wherein the tamper-evident cap consists of two sleeve parts, wherein the sleeve parts are separable from one other by separation seams and are integrally connected to one another via an annular groove with a reduced cross section, and wherein the sleeve parts can be pulled apart with a pull tab.

11. The packaging sleeve of claim 1, wherein the threaded screw connection comprises a threaded region on each of the sleeve body and the sealing stopper, wherein the sealed rotational position therebetween comprises a haptically perceptible latching position.

12. The packaging sleeve of claim 11, wherein the haptically perceptible latching position comprises a latching recess on a periphery of the threaded region on the sleeve body and a latching groove within the threaded region of the sleeve body.

13. A medical packaging sleeve comprising: an approximately cylindrical sleeve body having an open end; a sealing stopper attachable to the open end of the sleeve body via a threaded screw connection to provide a tight seal therebetween; a sleeve-shaped tamper-evident cap that extends over the sealing stopper for sterile use, wherein a position of the sealing stopper is fixable by the tamper-evident cap when the tamper evident cap is engaged with the sleeve body; and a marking symbol on each of the sealing stopper and the sleeve body that provide a visual indication of a sealed rotational position between the sealing stopper and the sleeve body; wherein the tamper-evident cap is non-rotatably connected to the sealing stopper and engageable with the sleeve body only in the sealed rotational position of the sealing stopper, wherein the non-rotatable connection between the sealing stopper and the tamper-evident cap consists of a manually actuatable toggle connected to the sealing stopper and engageable in a shape-adapted opening on an end of the tamper-evident cap.

14. The packaging sleeve of claim 13, wherein the shape adapted opening comprises two ribs formed on an inner surface of the end of the tamper-evident cap and configured to accept the toggle of the sealing stopper.

15. The packaging sleeve of claim 13, wherein the shape adapted opening comprises a slot in the end of the tamper-evident cap through which the toggle of the sealing stopper protrudes.

16. A medical packaging sleeve comprising: an approximately cylindrical sleeve body having an open end; a sealing stopper comprising a manually actuatable toggle on a top end, at least one elastomeric sealing lip on an outer periphery configured to engage an inner annular surface of the sleeve body, and a threaded region on the outer periphery configured to engage a corresponding threaded region on the inner annual surface of the sleeve body to provide a tight seal therebetween; a sleeve-shaped tamper-evident cap that extends over the sealing stopper for sterile use, wherein a position of the sealing stopper is fixable by the tamper-evident cap when the tamper evident cap is engaged with the sleeve body; and a marking symbol on each of the sealing stopper and the sleeve body that provide a visual indication of a sealed rotational position between the sealing stopper and the sleeve body; wherein the tamper-evident cap is non-rotatably connected to the sealing stopper and engageable with the sleeve body only in the sealed rotational position of the sealing stopper, and wherein the toggle of the sealing stopper is engageable in a shape-adapted opening on an end of the tamper-evident cap.

17. The packaging sleeve of claim 16, wherein at least one axially projecting centering lug is disposed on a lower sleeve part of the tamper-evident cap and alignable with an upwardly open latching groove disposed on a periphery of the packaging sleeve, and wherein the tamper-evident cap can be pushed onto the sleeve body only when the sealing stopper is in the sealed rotational position on the sleeve body.

18. The packaging sleeve of claim 17, wherein the lower sleeve part of the tamper-evident cap is configured as a radially elastically expandable latching collar comprising inclined inlet bevels, wherein the latching collar can be snapped on over an annular collar of the sleeve body in a radially expandable manner.

19. The packaging sleeve of claim 16, wherein the tamper-evident cap consists of two sleeve parts, wherein the sleeve parts are separable from one other by separation seams and are integrally connected to one another via an annular groove with a reduced cross section, and wherein the sleeve parts can be pulled apart with a pull tab.

20. The packaging sleeve of claim 16, wherein the shape adapted opening comprises either two ribs formed on an inner surface of the end of the tamper-evident cap and configured to accept the toggle of the sealing stopper, or a slot in the end of the tamper-evident cap through which the toggle of the sealing stopper protrudes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention is explained in more detail in the following on the basis of drawings showing only one possible design. Further essential features and advantages of the invention will emerge from the drawings and their description.

(2) The Figures show:

(3) FIG. 1 show a perspective view of a packaging sleeve without the tamper-evident cap in the sealing position of the sealing stopper.

(4) FIG. 2 shows a sealing stopper of FIG. 1 in a side view.

(5) FIG. 3 shows a perspective view of the sealing stopper of FIG. 2.

(6) FIG. 4 shows the depiction of the packaging sleeve of FIG. 1 without the sealing stopper.

(7) FIG. 5 shows the depiction of the packaging sleeve with the sealing stopper and a tamper-evident cap in a first design.

(8) FIG. 6 shows the same depiction as FIG. 5 with a tamper-evident cap in a second design.

(9) FIG. 7 shows a section through the tamper-evident cap of FIG. 6.

(10) FIG. 8 shows a section through the tamper-evident cap of FIG. 5.

(11) FIG. 9 shows a section through the packaging sleeve without a tamper-evident cap according to FIG. 1.

(12) FIG. 10 shows an enlarged section of FIG. 9.

(13) FIG. 11 shows a section of FIG. 10 with a partially placed tamper-evident cap in the unsecured position.

(14) FIG. 12 shows the same depiction as FIG. 11 with the other embodiment of the tamper-evident cap in the unsecured position.

(15) FIG. 13 shows the perspective side view of the packaging sleeve of FIG. 1 without the tamper-evident cap with the depiction of the securing position between the sealing stopper and the packaging sleeve.

(16) FIG. 14 shows the partial securing position of the mechanical securing of a first embodiment of the tamper-evident cap, wherein the non-rotatable connection has not yet been established.

(17) FIG. 15 shows the same depiction as FIG. 14 with the tamper-evident cap in the second design.

(18) FIG. 16 shows the depiction of the incorrect rotational position between the sealing stopper and the packaging sleeve.

(19) FIG. 17 shows the depiction of an incorrect rotational position between the first embodiment of the tamper-evident cap and the packaging sleeve.

(20) FIG. 18 shows the depiction of the incorrect rotational position between the second embodiment of the tamper-evident cap and the packaging sleeve.

(21) FIG. 19 shows the securing position of the packaging sleeve with a completely snapped-on tamper-evident cap in the second design.

(22) FIG. 20 shows the finished securing position of the packaging sleeve with the tamper-evident cap in the first design.

(23) FIG. 21 schematizes the serial arrangement of a control chain having different control measures.

(24) FIG. 22 shows the depiction of FIG. 21 with a depiction of the sequence of the different control chains associated with one another when connecting the mentioned parts.

DETAILED DESCRIPTION OF THE INVENTION

(25) The packaging sleeve 1 of FIG. 1 consists essentially of a hollow cylindrical sleeve body 2, preferably of a transparent plastic. The type of packaging sleeve and its function is the subject matter of the older patent application DE 10 2015 012 898 A1, for example.

(26) Reference to the description found there is made in relation to the following description.

(27) The sleeve body 2 is usually cylindrical. It can, however, also be configured as an oval body, wherein it is required that the upper and lower end faces of the sleeve body with the collars placed thereupon are cylindrical.

(28) The bottom of the sleeve body 2 is formed by the base of a cone 3, which is closed at the bottom.

(29) In the area of the base of the cone 3 or above it, lobe-shaped lugs 4 are provided, which project radially beyond the outer periphery of the sleeve body 2 and provide a means to prevent the sleeve body 2 from rolling. The sleeve body 2 should therefore not roll off a storage surface. This is prevented by the lugs 4.

(30) In FIG. 2, the packaging sleeve 1 is shown without a sealing stopper 5. It consists essentially of an upper sealing collar 7, at the upper annular edge 38 of which a first sealing surface 39 is configured in relation to the sealing stopper 5 to be discussed later.

(31) A visually discernible marking symbol 13 is also disposed in the area of the sealing collar 7.

(32) The sealing collar 7 is adjoined by an annular collar 8 with an enlarged diameter, on the outer periphery of which at least one, but preferably two, separate latching grooves 12 are incorporated.

(33) The annular collar 8 is adjoined in axial direction by a threaded region 9 with a reduced diameter, in which a thread 10 with associated thread helices is formed.

(34) An upwardly open latching groove 11, which is formed as a recessed region on the periphery of the threaded region 9, is also disposed in the threaded region 9.

(35) The sealing stopper 5, which is to be sealingly inserted into the sleeve body 2, is shown in more detail in FIGS. 2 and 3. It consists of an upper toggle 6, which is integrally connected to the plastic material as a handle for the rotation of the sealing stopper 5 and is connected to said stopper in the region of an annular extension 19.

(36) A visually discernible marking symbol 14, which must be brought into alignment with the sleeve body-side marking symbol 13, is disposed in the region of the annular extension 19.

(37) The annular extension 19 is adjoined by a region which is reduced in diameter and is formed by spaced apart, parallel sealing lips 15 which, in conjunction with the associated inner surfaces of the sleeve body 2, form the sealing surfaces 36a, 36b to be described later.

(38) This two-fold sealing region with respect to the sealing surfaces 36a, 36b, is adjoined by a reduced-diameter sealing ring 35, which transitions into a threaded extension 16 in which a thread is formed of which a thread helix 17 is visible.

(39) A latching recess 43, which cooperates in the threaded region 9 with an associated latching groove 11 on the outer periphery of the sleeve body 2, is formed in the area of the thread helix 17.

(40) The latching recess 43 engages in the latching groove 11 only when the thread 17 of the sealing stopper 5 is inserted into the associated thread 10 of the sleeve body 2 in the proper position. The operator is thus haptically informed that the end stop for the engaged threads 10, 17 is reached during a rotational movement.

(41) Thus, during assembly, the rotational position of the sealing stopper 5 in the sleeve body 2 of the packaging sleeve 1 is haptically controlled.

(42) However, such a haptic control that is provided only as an additional measure to the visual inspection shown in FIG. 1 can be omitted.

(43) If, once the correct rotational position between the sealing stopper 5 and the sleeve body 2 is reached, according to FIG. 1 the marking symbol 14 disposed on the sleeve body 2 is opposite to the marking symbol 13 disposed on the sleeve body.

(44) This positionally secured rotational position between the sealing stopper 5 and the sleeve body 2 simultaneously ensures that the sealing surfaces 36a, 36b (see FIG. 3) at the inner periphery of the sealing collar 7 are functioning.

(45) The thusly set rotational position, which can on the one hand be achieved by the alignment of the marking symbols 14, 15, and (additionally optionally) on the other hand by the haptic engagement of the latching recess 43 into the latching groove 11, makes it possible to check and secure the securing position of both embodiments of the tamper-evident caps 20, 30.

(46) It should also be noted that the sealing stopper 5 is hollow and the stopper end 18 does not constitute a closure. The closure of the sealing stopper 5 takes place in the area of the annular extension 19.

(47) Coming back to FIGS. 5 and 6, it is stated that the first embodiment of the tamper-evident cap 20 consists of two separable sleeve parts 21, 22 which can integrally be separated in the plastic material by two cross section-reduced separation seams 24, 25, wherein the two separation seams 24, 25 are connected to one another by a tear-off pull tab 23, if the pull tab 23 has not yet been actuated.

(48) The difference between the tamper-evident cap 20 of FIG. 5 and the tamper-evident cap 30 of FIG. 6 is that, according to FIG. 8, a slot opening 27 is provided in the upper cap area of the tamper-evident cap 20 of FIG. 5, by means of which the toggle 6 engages through the sealing stopper 5 in a rotationally secured manner, as shown in cross section in FIG. 12 for example.

(49) However, in the tamper-evident cap 30 of FIG. 6, the upper sleeve part 31 is formed by a self-contained cap, which accommodates the toggle 6 of the sealing stopper 5 in its interior in a rotationally secured manner, as shown in FIG. 7.

(50) FIG. 7 shows that the toggle is accommodated in a receiving opening 33 on the inside of the upper sleeve part 31, wherein the receiving opening is formed by two ribs 32 which are spaced apart and axially directed inward.

(51) It can also be seen that both tamper-evident caps 20, 30 are provided on the lower sleeve part 22 with at least one axially projecting centering lug 26, which cooperates with the previously described latching groove 12 on the outer periphery of the sleeve body 2.

(52) From the sectional views of FIGS. 7 and 8, it can further be seen that the lower sleeve part 22 of the tamper-evident cap 20, 30 is configured as a latching collar 28 comprising inclined inlet bevels 29, so that both tamper-evident caps 20, 30 are pushed onto the sleeve body in the sense of a push-type assembly (see FIGS. 11 and 12) and connected to one another in the proper position, as shown in FIGS. 14 and 15.

(53) In the securing position (final position), the respective at least one centering lug 26 of the lower sleeve part 22 of the tamper-evident cap 20, 30 engages in the associated upwardly open latching groove 12 of the sleeve body 2.

(54) FIGS. 9 and 10 show the finished sealing position of the sealing stopper 5 with a control of the rotational position, in which it can be seen that the sealing stopper 5 is configured as a two-part piece that was, however, produced in a single plastic injection molding process. According to FIGS. 9 and 10, an annular extension 19b made of a different material is formed on the outer periphery of the sealing stopper 5 and forms a one-piece part with the upper annular extension 19a, which is, however, made of a different material.

(55) Thus, according to FIG. 10, a first sealing surface 39 is formed between the annular edge 38 of the sleeve body 2 and the associated edge of the softer material annular extension 19b.

(56) Adjoining this in axial direction are two separate, further sealing surfaces 36a, 36b.

(57) Each of the sealing surfaces is formed by a peripheral sealing lip 15, wherein the sealing lips are formed parallel, spaced apart and peripherally in the softer material annular extension 19b. They thus form the aforementioned axially separated sealing surfaces 36a, 36b on the inner periphery of the sleeve body 2.

(58) A circumferentially enlarged annular collar 8 forms an annular groove 37, which is, however, present only for manufacturing reasons.

(59) The threaded screw region of the engaged threads between the thread 10 of the sleeve body 2 and the thread helices 17 of the sealing stopper 5 is disposed below the annular groove 37.

(60) FIGS. 11 and 12 show a working position of the two tamper-evident caps 20, 30, wherein the securing connection with the sleeve body 2 of the packaging sleeve 1 has not yet been established. It can thus be seen that the latching collar 28 is still resting on the upper side of the annular collar 8, and has not yet been brought into engagement with the latching edge 47 on the lower side of the annular collar 8.

(61) FIGS. 11 and 12 thus show both tamper-evident caps 20, 30 in an intermediate position prior to reaching their positionally secured latching position.

(62) As the assembly progresses further, the respective tamper-evident cap 20, 30 is thus pressed downward in the direction of the arrow 40, and the latching collar 28 consequently expands radially and arrives at a position over the annular collar 8. The inlet bevel 29 slides over the upper surfaces of the annular collar 8 and then brings the lower latching collar 28 into a positionally secured engagement of the latching edge 47 of the annular collar 8.

(63) FIG. 13 shows the visually controllable securing of the rotational position between the sealing stopper 5 and the sleeve body 2 of the packaging sleeve 1, because it can be seen that the sealing stopper 5 with its marking symbol 14 must be brought into alignment with the marking symbol 13 of the sleeve body 2.

(64) If this rotational position is not reached, the two marking symbols 13, 14 deviate from one another, which then results in a visually controllable incorrect position as shown in FIG. 16.

(65) The visually identifiable incorrect position of FIG. 16 is continued in the depiction of FIGS. 17 and 18, because it can be seen that, when the respective tamper-evident cap 20, 30 is placed onto the sealing stopper 5 in the incorrect position of FIG. 16, the axially projecting centering lug 26 is not in engagement with the sleeve body-side latching groove 12 as shown in FIGS. 17 and 18.

(66) Incorrect assembly is thus impossible.

(67) The reason for this safety measure is that the toggle 6 of the sealing stopper 5 is non-rotatably connected to the respective tamper-evident cap 20, 30 and, in this “incorrect” rotational position according to FIG. 16, cannot be brought into engagement in the sleeve body-side latching groove 12 with its centering lug 26.

(68) The two completely established securing positions are shown in cross section in FIGS. 19 and 20. FIG. 19 shows the tamper-evident cap 30 in its completed securing position, wherein it is now ensured that the securing position can be established only when the sealing stopper 5 is completely screwed into the sleeve body 2 and sealed, and also only then can the lower latching collar 28 of the tamper-evident cap 30 be brought into engagement with the associated latching edge 47 of the annular collar 8 of the sleeve body 2.

(69) FIG. 20 also shows the positionally secured latching position of the tamper-evident cap 20.

(70) If the sealing stopper 5 is not completely screwed onto the sleeve body 2, this is indicated by the lack of alignment of the two markers 13 and 14 on the one hand, and, on the other hand, a gap 42 forms between the sleeve body 2 and the sealing stopper 5 as in FIG. 16.

(71) FIG. 21 schematically shows the succession of the various control mechanisms of the invention.

(72) In the first control stage, the alignment of the marking symbols 13, 14 between the sealing stopper 5 and the sleeve body 2 is checked with the visual inspection 44.

(73) In the second control stage, the mechanical position control 45, the positional association between the sealing stopper 5 and the sleeve body 2 is additionally checked by means of haptic feedback, in that the latching recess 43 disposed on the sealing stopper 5 engages in the associated latching groove 11 on the outer periphery of the sleeve body 2 in a haptically perceptible manner.

(74) In the third control stage, a further position control 46 is created, which ensures a secure rotational position and closing position between the tamper-evident cap 20, 30 and the sleeve body 2, in that the one or more centering lugs 26 disposed on the tamper-evident cap 20, 30 can be brought into engagement with the sleeve body-side latching grooves 12 only when the correct rotational position between the sealing stopper 5 and the sleeve body 2 has been established.

(75) According to FIG. 22, this is a chain of control steps, wherein a haptically perceptible position control between the sealing stopper and the sleeve body 2 can additionally be provided after the first visual inspection 44, but can also be omitted.

(76) The decisive factor here is the mechanical position control 46 between the tamper-evident cap and the sleeve body 2, wherein this position control only works if the sealing stopper 5 is covered by the tamper-evident cap 20, 30 in the correct position.

(77) TABLE-US-00001 Drawing legend 1 Packaging sleeve 2 Sleeve body 3 Base of the cone 4 Base 5 Sealing stopper 6 Toggle 7 Sealing collar (of 1) 8 Annular collar (of 1) 9 Threaded region 10 Thread 11 Latching groove (for 5) 12 Latching groove (for 20) 13 Marking symbol (of 1) 14 Marking symbol (of 5) 15 Sealing lips (of 5) 16 Threaded extension 17 Thread helix (of 5) 18 Stopper end 19 Annular extension a, b 20 Tamper-evident cap 21 Sleeve part (top) 22 Sleeve part (bottom) 23 Pull tab 24 Separation seam top 25 Separation seam bottom 26 Centering lug 27 Slot opening (for 6) 28 Latching collar 29 Inlet bevel 30 Tamper-evident cap 31 Sleeve part (top) 32 Rib 33 Receiving opening (for 6) 34 Opening 35 Sealing ring (of 5) 36 Sealing surface a, b 37 Annular groove 38 Annular edge (of 1) 39 Sealing surface (of 38) 40 Direction of the arrow 41 Stop surface (of 1) 42 Gap 43 Latching recess (of 5 in 11) 44 Visual inspection (between 1 & 5) 45 Position control (between 1 & 5) 46 Position control (between 20, 30 & 1 47 Latching edge (of 8)