Medical packaging with a packaging sleeve and outer vacuum packaging

Abstract

Medical packaging for the sterile storage of medical articles in a hermetically and sterile sealable packaging sleeve. The packing generally includes at least two parts, with a sealed, film-like outer packaging, which at least partially encloses the packaging sleeve in a form-fitting manner and provides a pressure that is reduced with respect to the atmosphere. At least one end face of the packaging sleeve may be designed to be flattened, wherein a length of the outer packaging is generally longer than a length of the packaging sleeve and projects beyond the end face region of the packaging sleeve. A sealing or welding seam may be arranged at least in the end face region of the packaging sleeve, wherein at least one of the end faces of the packaging sleeve, preferably both end faces, are designed so as to be flattened off. The end-sided transition from the packaging sleeve into the outer packaging is substantially wrinkle free.

Claims

1. A medical packaging for the sterile storage of medical articles in a hermetically sealable, sterile packaging sleeve, the packaging comprising: a packaging sleeve having at least two sleeve parts connectable to form an air tight seal to contain a medical article therein, the packaging sleeve having opposite end face regions, wherein each of the end face regions form a streamlined profile which tapers from a larger periphery of the packaging sleeve to an end that is reduced in thickness and rounded, and wherein the end of at least one of the end face regions is shaped as a beak or a pointed cone; and a film-like outer packaging that encloses the packaging sleeve, wherein the outer packaging comprises at least one end sealed with a sealing or welding seam, and wherein the outer packaging has a negative pressure with respect to atmospheric pressure, and as a result, the outer packaging surrounds the packaging sleeve on all sides in a form-fitting manner, wherein a length of the outer packaging is longer than a length of the packaging sleeve so that the outer packaging projects beyond the end face regions of the packaging sleeve to form projecting lengths, wherein the sealing or welding seam is arranged in at least one of the projecting lengths of the outer packaging adjacent the end face region of the packaging sleeve to form a sealed projecting length, and wherein the sealed projecting length of the outer packaging is configured to achieve a continuous transition from the end face region of the packaging sleeve to the sealing or welding seam so that it remains substantially wrinkle free when surrounding the packaging sleeve in the form-fitting manner under the negative pressure.

2. The medical packaging of claim 1, wherein the packaging sleeve comprises an approximately cylindrical cross section, and the streamlined profile of at least one end face region is flattened off perpendicular to a width of the packaging sleeve.

3. The medical packaging of claim 1, wherein the streamlined profile of the at least one end face region shaped as the beak comprises a width approximately equal to a diameter of the cylindrical packaging sleeve.

4. The medical packaging of claim 1, wherein the at least two sleeve parts of the packaging sleeve are connectable to one another in a sealing fashion with a screw connection.

5. The medical packaging of claim 1, wherein the at least two sleeve parts of the packaging sleeve are connectable to one another in a sealing fashion by sliding one packaging part onto the other packaging.

6. The medical packaging of claim 1, wherein the outer packaging can be peeled open on the at least one end comprising the sealing or welding seam.

7. The medical packaging of claim 6, wherein the sealing or welding seam is formed at an approximately acute angle in the manner of a V shape.

8. The medical packaging of claim 1, wherein the outer packaging comprises two ends sealed with a sealing or welding seam, wherein the outer packaging can be peeled open on one or both of the sealing or welding seams.

9. The medical packaging of claim 8, wherein one of the sealing or welding seams is formed at an approximately acute angle in the manner of a V shape.

10. The medical packaging of claim 2, wherein the at least one end face region that is flattened off is mirror symmetrical to a longitudinal center axis of the packaging sleeve.

11. The medical packaging of claim 2, wherein the at least one end face region that is flattened off is asymmetrical to the longitudinal center axis of the packaging sleeve.

12. The medical packaging of claim 2, wherein an axial length of the at least one end face region that is flattened off corresponds to approximately twice a diameter of the packaging sleeve.

13. The medical packaging of claim 2, wherein a thickness of a distal tip of the at least one end face region that is flattened off corresponds to approximately 1/10 a diameter of the packaging sleeve.

14. The medical packaging of claim 2, wherein the at least one end face region that is flattened off comprises a linear longitudinal extent.

15. The medical packaging of claim 2, wherein the at least one end face region that is flattened off comprises a curved longitudinal extent having a spoon shape.

16. The medical packaging of claim 1, wherein at least an inner space of the packaging sleeve is sterile.

17. The medical packaging of claim 1, wherein the negative pressure of the outer packaging forms a vacuum intermediate space between the outer packaging and the packaging sleeve, wherein the vacuum intermediate space is sterile.

18. The medical packaging of claim 1, wherein the streamlined profile of at least one end face region is flattened off perpendicular to a width of the packaging sleeve and tapers into a curved end.

19. A medical packaging for the sterile storage of medical articles in a hermetically sealable, sterile packaging sleeve, the packaging comprising: a packaging sleeve having at least two sleeve parts connectable to form an airtight seal to contain a medical article therein, the packaging sleeve having: a necking in a central region of the at least two sleeve parts to better secure the medical device in position, and opposite end face regions having a streamlined profile that tapers from a larger periphery of the packaging sleeve to an end that is reduced in thickness and rounded; and a film-like outer packaging that encloses the packaging sleeve in a form-fitting manner, wherein the outer packaging comprises at least one end sealed with a sealing or welding seam, and wherein the outer packaging has a negative pressure with respect to atmospheric pressure, wherein a length of the outer packaging is longer than a length of the packaging sleeve so that the outer packaging projects beyond the end face regions of the packaging sleeve to form projecting lengths, wherein the sealing or welding seam is arranged in at least one of the projecting lengths of the outer packaging adjacent the end face region of the packaging sleeve to form a sealed projecting length, and wherein the sealed projecting length of the outer packaging is configured to achieve a continuous transition from the end face region of the packaging sleeve to the sealing or welding seam so that it remains substantially wrinkle free when surrounding the packaging sleeve in the form-fitting manner under the negative pressure.

20. The medical packaging of claim 19, wherein the streamlined profile of at least one end face region is flattened off perpendicular to a width of the packaging sleeve and tapers into a curved end.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention is explained in greater detail below with reference to the drawings that depict only one way of carrying out the invention. At the same time other features, which are essential for the invention, and advantages of the invention will become apparent from the drawings and their description.

(2) The drawings show:

(3) FIG. 1A shows a packaging sleeve with an outer vacuum packaging in accordance with the prior art with an undesired wrinkle formation.

(4) FIG. 1B shows a cross-section of the prior art embodiment shown in FIG. 1B.

(5) FIG. 2A shows a packaging in an adapted tubular film in accordance with the present invention.

(6) FIG. 2B shows a cross-section of the adapted tubular film illustrated in FIG. 2B.

(7) FIGS. 3A-3C show various possible cross-sections of the packaging sleeve shown in FIG. 2A.

(8) FIG. 4 shows the scaled up representation of the adjoining region between the inner packaging sleeve and the outer packaging in the end face region of the prior art.

(9) FIG. 5 shows the representation from FIG. 4 rotated by 90 degrees (as the prior art).

(10) FIG. 6 shows the outer packaging, according to the prior art, with a packaging sleeve inserted into said outer packaging, with depiction of an undesired wrinkle formation.

(11) FIG. 7 shows the plan view of an inventive packaging sleeve with an outer vacuum packaging in a plan view.

(12) FIG. 8 shows the plan view, according to FIG. 7, with a composite representation of the packaging.

(13) FIG. 9 shows the representation of a packaging sleeve, wherein the upper part is shown in a plan view; and the bottom part, in a lateral view.

(14) FIG. 10 shows the enlarged representation from FIG. 8, showing other details in conjunction with an improved bending behavior.

(15) FIG. 11 shows the representation, as in FIG. 10, as both film ends are peeled open, where in this case the assistance of finger pressure for improved removal is shown.

(16) FIG. 12 shows the position of the packaging rotated by 90 degrees, as compared to the position shown in FIG. 11.

(17) FIGS. 13A-13D show representations of the flat ends of the packaging sleeve in a plan view, and FIGS. 13E-13H show representations of the flat ends of the packaging sleeve in cross section.

(18) FIG. 14 shows the representation of the tubular film with the cut lines being affixed for purposes of an improved peeling open.

(19) FIG. 15 shows an exemplary embodiment of a packaging sleeve with an outer vacuum packaging with the end of the film being peeled open.

(20) FIG. 16 shows the advancing unpacking of the packaging sleeve, according to FIG. 15, as the packaging sleeve is squeezed out of the outer packaging.

(21) FIG. 17 shows the representation rotated by 90 degrees, as compared to FIG. 16.

(22) FIG. 18 shows the lateral view of a flat end in a symmetrical design.

(23) FIG. 19 shows the plan view of an embodiment, rotated by 90 degrees, according to FIG. 18.

(24) FIG. 20 shows the lateral view of an asymmetrical flat end in three different embodiments.

(25) FIG. 21 shows the plan view of the representation, rotated by 90 degrees, according to FIG. 20, in only one embodiment.

(26) FIG. 22 shows representation of the streamlined transition profile of the packaging sleeve,

DETAILED DESCRIPTION OF THE INVENTION

(27) FIG. 1 shows the prior art of a packaging sleeve, wherein the packaging sleeve is enclosed in an outer vacuum packaging.

(28) FIG. 1 shows a round cylindrical container 1, which, however, according to FIGS. 3A-3C, could also have a cross section of any kind, for example, a round cross section, a square cross section or a polygonal cross section, as shown with the reference numerals 3, 3a and 3b, respectively.

(29) FIG. 1 also shows in a cross section, how wrinkles 7 and air pockets 40 form in an undesired fashion, in particular, on the end faces of the container 1 when a vacuum is applied to the outer packaging 4. Said wrinkles and air pockets should be avoided, because they form predetermined breaking points in the outer packaging after prolonged use, storage or transport. Therefore, it is possible to break through the first sterility barrier.

(30) In the exemplary embodiment according to the prior art shown in FIG. 1, the outer packaging 4 is hermetically sealed by means of upper and bottom welding seams 5.

(31) It is shown by means of the dashed lines that it is also possible to arrange, if desired, the welding seams 33 on the longitudinal sides, so that the outer packaging 4 has to be designed, according to the prior art and according to the present invention as well, not only as a tubular film, but it may also consist of two parallel webs, which are connected lengthwise in each case by the illustrated welding seams 5, 33.

(32) In the inner space of the container 1 there is arranged a product 2 of any kind that can be designed, according to the general description, for example, as a tool or as any other object in the form of an item (for example, also as a packaging sleeve).

(33) It is important that the end face 3 of the container 1, according to the prior art, be planar and flat. That means that said end face does not taper off in the distal direction, but rather is designed, for example, as a round cylindrical disk or the like.

(34) When the air is extracted from the inner space of the outer packaging, said outer packaging is supposed to nestle against the packaging sleeve, disposed in the inner space, as form-fitting and as wrinkle free as possible.

(35) In this case an undesired transition region 6 forms in the region of the outer packaging 4; and when the air is extracted from the inner space of the outer packaging, air pockets 40 form in the region of the wrinkles 7 in said transition region.

(36) As a result of the layers of film in the outer packaging sticking together when the air is extracted, wrinkles 7 form in an undesired fashion in the end face region 3. These wrinkles form flexurally rigid, embrittled film regions, which then lead to breaking points in the transition region 6 when the end-sided end is bent, so that the tightness of the outer packaging ceases to exist. This aspect is shown in the lateral view in FIGS. 4 and 5, respectively, where it can be seen that, in addition to the undesired air pockets, above all, the undesired wrinkles 7 are formed, that result in the outer packaging breaking open when said wrinkles are repeatedly bent.

(37) FIG. 6 shows the same parts, as in FIG. 2, with the depiction of other details. For example, it can be provided that the container 1 is designed so as to be continuous and is closed, for example, with a cover 36; and it can be provided in another embodiment that the container 1 consists of two interconnected sleeve parts 28, 29, an aspect that will be explained in greater detail below with reference to the description of the present invention.

(38) FIG. 7 shows at this point the upper end of an inventive packaging sleeve with an outer vacuum packaging, where it can be seen that the container 1 now consists of two sleeve parts 28, 29, which are connected to one another in a sealed fashion by means of a plug or screw region 32 in the region of a sealing closure 34.

(39) It is not shown that the sealing closure 34 in the region of the plug or screw region 32 can also be equipped with additional sealing measures; for example, O-ring seals can be arranged there. An adhesive bonding can also be present; or an intrinsic air-tight plug or screw connection. Similarly labels, which are glued on in a sealing fashion, may also be used in this sealing closure region, and so on and so forth.

(40) What is important is that a sterile atmosphere is maintained in the inner space of the container 1, i.e., thus, in the inner space of the sleeve parts 28, 29, because the sealing closure 34 prevents bacteria from entering into the inner space of the sleeve parts 28, 29.

(41) It goes without saying that it is possible in an additional embodiment that the sleeve parts 28, 29 are not designed in a mirror symmetrical identical fashion, but rather the one sleeve part 29 can be designed such that it is very long; and the other sleeve part 28 can be designed—in an axially shortened embodiment—only as a screw or plug closure in a cover-like manner.

(42) FIG. 7 shows a specific embodiment of the inventive flat end 8, which forms the end face of the sleeve part 28.

(43) It can be seen that the two end faces of the sleeve parts 28, 29 may be designed as the flat ends 8, 9; and it can also be only provided in another embodiment that only the end face of one sleeve part 28 or 29 may be designed as the flat end 8 or 9.

(44) For the sake of a simpler description only one single flat end 8 on the sleeve part 28 is described in accordance with the invention. In this case it is assumed preferably, but not exclusively, that the other sleeve part 29 may also be provided with such a flat end 9.

(45) The exemplary embodiment, according to FIGS. 7 and 8, shows a particular A-shaped sealing or welding seam 15, which consists in total of two legs 15a, 15b, which run at an acute angle to each other and which converge at a central tip 15c. Said legs form an acute angle 15d, because the tubular film is then notched on the end face, in order to peel open at the illustrated cut lines 27, in order to obtain in this way two film sheets 17, 18, which can be separated from one another. What is important is that the sealing or welding seam 15 also extends as far as up to the lateral edges of the tubular film, in order to obtain in this way a tight closure on both opposite ends 20.

(46) Thus, when the two film sheets 17, 18 are separated in the direction of the arrow 19 (see FIG. 11), the two film sheets 17, 18 can be separated from one another. The A shape of the sealing or welding seam 15 has the advantage of easy and controlled separability of both film sheets 17, 18 in the illustrated directions of the arrows 19 (see FIG. 11), because the separating force acts initially in a weaker manner on the tip 15c of the sealing or welding seam 15 and then propagates, as the ripping movement becomes stronger, into the two legs 15a, 15b, which are arranged at an angle to one another.

(47) The reference numeral 30 denotes in general that the outer packaging 4 is designed, according to the present invention, as a tubular film 30.

(48) However, it can also be provided in an additional embodiment that, instead of a tubular film, it is possible to use film sheets 17, 18, which run parallel to one another and which are connected to one another—straight or curved—on the longitudinal sides by means of a respective sealing or welding seam 33 (see FIG. 1).

(49) As already stated above in the general part, the two sleeve parts 28, 29 are connected in a plug or screw region 32 and form a sealing closure 34, which ensures that the inner space of the container 1 is completely air tight with respect to the atmosphere and is closed with respect to the inner space of the outer packaging and the tubular film 30.

(50) Moreover, it is stated in a preferred embodiment of the present invention that a necking 31 is present in the central region of the two sleeve parts 28, 29 (FIG. 9); and this necking ensures that the article, for example, a cylindrical article, such as, for example, a milling machine, a drill or a surgical instrument, which is disposed in the inner space, is better secured in position.

(51) What is important according to the invention is that in the plan view one end face or both end faces of the two sleeve parts 28, 29 is/are designed now as flat ends 8, 9.

(52) FIG. 9 shows two representations, which are spatially rotated with respect to one another. That means that the upper part in FIG. 9 shows the flat end 8 in the lateral view, while the bottom part of the representation in FIG. 9 shows the same sleeve part in a view that is rotated by 90 degrees, where it can be seen that the flat end 8, 9 tapers off to a point in a longitudinally symmetrical fashion and has a small radius 35 at the tip.

(53) Therefore, the width 37 of the flat end is much thinner than in comparison to the diameter of the container 1 and is about 1/10 the diameter of the container 1 in the rest of the region.

(54) Given a container diameter 1 of, for example, 20 mm, the thickness 37 of the respective flat end 8, 9 is then only, for example, 2 mm.

(55) As a result of the preferred blow molding method, the flat end has a wall thickness, which is larger in size—due to the method; and this wall thickness forms a penetration barrier for a tool that has sharp points and that rests on said barrier.

(56) The axial length of the flat end can be chosen as desired. In the illustrated exemplary embodiment the flat end has, for example, a longitudinal extent of 50 mm. Preferably, a length corresponding to twice the diameter of the container 1 is chosen.

(57) Similarly it can be provided that the length 41 of the flat end 8, 9 corresponds to about the diameter of the container 1. However, it is also possible to select the diameter in such a way that it is twice or triple the length 41.

(58) In the exemplary embodiment according to FIG. 8, the bottom end of the tubular film 30 is also shown as a sealing or welding seam 5 that deviates from the upper sealing or welding seam 15.

(59) Therefore, in the exemplary embodiment according to FIGS. 7 and 8, the upper sealing or welding seam 15 is provided for removing the container 1, while the bottom sealing or welding seam 5 is usually not to be opened.

(60) FIGS. 10 and 11 show that, on account of a lack of the formation of wrinkles or the avoidance of a formation of wrinkles, bending the film region of the outer packaging in the region of a kink point 12 does not lead to a break in the outer packaging in this region, because this region no longer has any wrinkles at all.

(61) Even in the transition region 6, which forms in the direction of the sealing or welding seam 15, there are no longer any wrinkles.

(62) FIG. 11 shows the process, by which a mirror symmetrically designed packaging sleeve, according to FIG. 10, is removed, where it can be seen that the upper flat end 8 is designed in exactly the same way as the bottom flat end 9; and, therefore, a particularly simple removal process can take place.

(63) If pressure is applied with the finger 22 to the bottom flat end 9 in the direction of the arrow 21, then the bottom flat end 9 in the outer packaging is pushed upwards in the direction of the arrow 24; and the upper flat end 8 can then be removed, provided that the two film sheets 17, 18 are pulled apart with the fingers of one hand in the direction of the arrow 19, so that the upper sealing or welding seam 15 is also torn open.

(64) FIG. 12 shows a modified exemplary embodiment, where it can be seen that the upper sealing or welding seam 15a can also be designed as a transverse closure, so that the result is also film sheets 17, 18 that can be separated from one another.

(65) It is also shown in FIG. 12 that since the flat end 9b is significantly rounded off, small wrinkles 14 are produced in an allowed manner in the bottom tubular end region 23, but said wrinkles do not have an adverse effect.

(66) In any event what is important is that the formation of wrinkles is avoided in at least one region of the tubular film 30, i.e., thus, in the region of the upper flat end 8 and/or in the region of the bottom flat end 9.

(67) However, the avoidance of a formation of wrinkles on both the upper and also the bottom side of the tubular film 30 is not always automatically necessary.

(68) FIGS. 13A-H show various design shapes of flat ends, where FIGS. 13A-D show the lateral view of various embodiments of flat ends 8, 9, while FIGS. 13E-H show the associated end views of these flat ends 8, 9.

(69) It is still specified that the flat ends form in each case tips 38, 39, so that the plan view of the tips 38, 39 in the various embodiments is also shown in the bottom representation.

(70) Therefore, the first column (FIGS. 13A, 13E) shows a tip 38a, 38b, which tapers off such that it is relatively pointed, and the flat end is designed so as to be approximately square and tapers (42a), therefore, into the tip 38a, 38b. The second column (FIGS. 13B, 13F) shows that the flat end 8b, 9b ends such that it is rounded off approximately in the shape of a beak (42b); and the plan view also shows a tip 38b, 39b that is reduced with respect to the diameter of the container 1.

(71) The third column (FIGS. 13C, 13G) shows a relatively acute angled embodiment of the flat end 8c, 9c; and the associated tips 38c and 39c extend exactly symmetrically, but start from an oval cross section (42c).

(72) In the right column (FIGS. 13D, 13H) the tip 38d, 39d is pointed even more and ends, moreover, in an approximately oval cross section (42d). Such a cross sectional shape has been found in tests to be an optimal solution.

(73) FIG. 14 shows the peeling open process that is shown in FIG. 11, where it can be seen that the film tube can be torn open along the cut lines 27.

(74) FIGS. 15 and 16 show a process for removing a container 1 with a product 2, enclosed therein, of the kind that has already been explained above with reference to FIG. 11. In this case the plan view is shown in FIG. 15; and the lateral view is shown in FIG. 16.

(75) FIG. 17 shows the almost completed removal position, so that now with the film sheets 17, 18 having been peeled off, the upper flat end 8 can be removed.

(76) FIGS. 18 and 19 show in conformity with the previous exemplary embodiments a mirror symmetrical configuration of the flat ends 8, 9 in a lateral view and a plan view, while FIGS. 20 and 21 show different embodiments of asymmetrically designed flat ends.

(77) FIG. 20 shows an asymmetrical flat end 8d, which is designed so as to be eccentric to the longitudinal center axis; and this flat end 8d can also take accordingly a shape 8d′ or a shape 8d″.

(78) FIG. 22 shows a drawing of the underlying principle, how a body, around which (gaseous or liquid) streamlines 43 flow, in the form of the packaging sleeve of the invention forms the transition profile 42. It can be seen that the transition profile 42 at the end faces of the packaging sleeve corresponds approximately to a streamline 43. That means that there is a continuous and harmonic transition from the larger cross section of the packaging sleeve in the center region into the flattened end face of the packaging sleeve in the manner of a streamline.

(79) TABLE-US-00001 List of Reference Numerals  1 container  2 product  3 end face  4 outer packaging  5 sealing or welding seam (at the bottom)  6 transition region  7 wrinkle  8 flat end a, b, c, d  9 flat end a, b, c, d 10 projecting end 11 welding seam 12 kink point 13 adjoining region 14 wrinkle 15 sealing or welding seam (tip) 15a leg 15b leg 15c tip 15d wrinkle 16 curved seam 17 film sheet 18 film sheet 19 direction of arrow 20 end (of 15) 21 direction of arrow 22 finger 23 tubular end 24 direction of arrow 25 cut line 26 finger surface 27 cut line 28 sleeve part 29 sleeve part 30 tubular film 31 necking 32 plug or screw region 33 welding seam (prior art) 34 sealing closure 35 radius 36 cover 37 thickness 38 tip a, b, c, d 39 tip a, b, c, d 40 air pocket 41 length 42 transition profile (streamlined) 43 streamline