CA1203760A

CA1203760A - Packing tube

Info

Publication number: CA1203760A
Application number: CA000435086A
Authority: CA
Inventors: Asok K. Roy; Horst-Dieter Klinke
Original assignee: Medi-Pharma Vertriebsgesellschaft MbH
Current assignee: Medi-Pharma Vertriebsgesellschaft MbH
Priority date: 1982-08-23
Filing date: 1983-08-22
Publication date: 1986-04-29
Also published as: BR8304531A; PH20873A; IL69308A; GR79361B; DD210006A5; DK383583D0; EP0101981B1; JPH0328215B2; AU565421B2; HU186340B; FI74256B; FI74256C; SU1314952A3; FI832992A0; DE3231314A1; EP0101981A2; FI832992A; PT77228A; DK383583A; KR840006123A

Abstract

ABSTRACT

A packaging tubule having a closing plug of an elastic material, in particular for a tampon for the medical diagnosis of pathological changes in humans and animals, for example in female body cavities, preferably in the vagina, is described. The packaging tubule has the special feature that the external dia-mater of the length section adjoining the opening of the packaging tubule is smaller than the external diameter of the remaining length section. This leads to the advantages that the packaging tubule is easy to manufacture, the objects packaged therein are permanently protected from air and light, and a standing surface for the packaging tubules can be utilized in the optimum manner.

Description

~376~

The ;nvent;on relates to a packag;ng tubule having a closing plug of an elastic material~ in parti-cuLar for a tampon for the medical d;agnosis of patho-logical changes in humans and animaLs, for example ;n female body cavities, preferably in the vagina.
Packaging tubules of metal, hav;ng an elast;c closing plug, are kno~n. They are used for packaging very diverse goods. The metal imparts a relatively high mechanical stability to tubules of this type and, for th;s reasonO the tubules are suitable for the packag-;ng of, in particular, shock sensitive and pressure-sens;t;ve objects or products, such as a medicament in tablet form.
Moreover, tampons are knoun which are intended~
for example, for female hygiene or for medical purposes.
These include special tampons uhich consist~ for example, of cotton f;bers and/or cellulose fibers and ~hich are coated or impregnated ~ith one or more chemical active ingredients for d;agnostic or therapeutic purposes.

Since these active ingredients must frequently, for example ;n the case of d;agnoses, react to very sm~ll mater;al changes, for example in a human body cavity, they are frequently themselves very sens;t;ve substances.
It ;s therefore necessary to protect these substances, or the carrier materials provided ~ith them, for example tampons impregnated ~;th a diagnostic agentJ from harm-ful env;ronmental ;nflwences, such as atmospheric oxygen~
atmospheric moisture and high-energy light~ from the time of their manufacture wp to their use. "High-energy ~e lY

light" is here to be understood as light (including ultra-violet light) of higher energy than red light. The pack-aging ~rapper selected for the tampon must therefore meet these requirements.
Since diagnostic and therapeutic tampons must be kept particularly clean until they are used, so that they ~ill not initiate interfering side reactions, the tampons are in most cases inserted into tampon appLi-cators even during their manufacture or immediately after-~ards. These applicators enable a tampon to be intro-duced into a body cavity, without the tampon being con-taminated by the fingers.
It is therefore desired to size packaging tubules for tampons of the said type in such a way that an appli-cator conta;n;ng a tampon can be packaged therein.
There are certain active ingredients which are stable over several months or years only if water is very largely excluded, for example ~ith a moisture con-tent of less than 1%. Tampons which contain such active ;ngred;ents must therefore be very thoroughly dried be-fore the pack3ging tubule is sealed. Freeze drying is one poss;bil~ty of ach;ev;ng th;s. To prepare it for this purpose, the applicator conta;ning the tampon is arranged ;n a packaging tubule positioned upright, in such a way that the introduction end of the tampon faces the opening of the packaging tubule. AFter 3 solution of active ingred;ent has been applied to the tampon, the packaging tubule is partially closed by a closing plug, ;s ;ntroduced into a freeze-dry;ng apparatus and ;s dr;ed ~2~376~

together ~ith its contents.
As a holding device for several packaging tubules in the freeze-drying apparatus, an a~uminum block has h;therto been used, ;n the surface of ~hich bores are provided at certain spacings; one packaging tubule can be placed into each of these bores~ In th;s ~ay, the packag;ng tubule positioned upright is secured against falling over and retains this position even in the freezP-dryin~ apparatus.
Since, howeverO the customary packaging tubules have a uniform external diameter over the major part of their length and a flanged end, projecting beyond th;s length, at the;r opening, and the gripping edge of the c~osing plug, placed thereon, also protrudes sometimes beyond the flanged edge, it ~as hitherto necessary always to maintain a certain spac;ng between the individual packa~;ng tubules in the alum;num block~ if all the tub-ules were to remain in a vertical position. Furthermore, tt is not possible, in the aluminum block, to make the bores for the packaging tubules infinitely close to one another. The consequence is that the given occupation area ln the freeze-drying apparatus cannot be utilized to the opt;mum ~ith the packaging tubules. Moreover, the manufacture of the sa;d aluminum block is expensive and its handling is ;nvolved.
It is the object of the invention to indicate a packaging tubule of metal, hav;ng a clos;ng plug of an elastic mater;al, in particular for a tampon for the med;cal diagnosis of pathological changes in humans and animals, or example in female body cavities, prefe-rably in the vagina. The packaging tubule should be easy to manufacture and should safely and permanently protect the tampons, which are packaged therein and are preferabl~ located in an applicator, away from air, in particular atmospheric humidity, and from light.
A further aim is that the packaging tubule should faci-litate the preparation of the tampon with an active ingredient. A further object is to ensure that the working area, in particular the occupation area in a freeze-drying apparatus, available for the manufacture of the packaged tampons is utilized in an optimum manner, that is to say that more packaging tubules per unit area can be dried.
According to the invention, there is provided in a packaging tubule having an opening, a closing plug and an external diameter which, in a length section adjoining the opening of the packaging tubule, is smaller than in the remaining length section, the improvemen~ wherein:
a~ the remaining length section e~tends from the bottom up to more than about three quarters of the length of the packaging tubule, b) the internal diameter of the length section adjoining the opening is slightly larger than the external diameter of the material to be packaged, and , ~3~

- 7a -c) the closing plug has at least one recess on the periphery of an inner end facing the packaging tubule.
The larger external diameter in the remaining length section of the packaging tubule makes it possible to place a multiplicity of such tubules next to one another, without using an aluminum block, and without any unutilized space remaining between two immediately adjacent tubules. In this way, the throughput in the freeze-drying apparatus can be approximately doubled.
A further result is that the packaging tubules are always in mutual contact over a relatively large length section. This leads to good heat transfer between the tubules, and this is important for uniform quality of the contents of the tubules. An even temperature control is of outstanding importance for this purpose.

37~

A further advantage is that the reduced external diameter t~ith a corresponding reduced internal diameter) of the packag;ng tubu~e in the length section adjo;ning the opening of the tubule shortens the heat transfer dis-tance from the tampon to the uall of the tubule. Conse-quently, the cooling and drying times are shorter.
The reduced external diameter has also the effect that a tampon applicator, ~hich has b~en introduced into the packa3ing tubule and which consists, for example, of 1~ an introduction sleeve and an eject;on sleeve ~hich is telescopically displaceable therein, is centered in the reg;on of the opening of the packaging tubule, that is to say it has only a small radial clearance opposite the ;nner wall of the tubule~ This substantially ;mproves the operat;onal reliability, ~hen a solution of an active ingredient is sprayed by means of an automatic device onto the introduction end of a tampon which is located in the applicator in ~he packaging tubule.

Since the external diameter from the bottom up to above about three quarters of the packaging tubule is greater than that at the opening, the resulting appearance of the packaging tubule is similar to that of a bottle.
In this case, it is particularly advantageous that such packaging tubules are in contact over a large length sect;on, ~hen they are placed close to one another. This leads to good heat transfer between the packaging tubules in the free2e-dryin~ apparatus.
Moreover, the closing plug of the packaging tubule has at least one recess on the periphery of its ~L~[)3'76C~

end fas;ng the packaglng tubule. This has the advantage that, even before the packaging tubule is introduced into the freeze-drying apparatus, the closing plug can be placed onto the tubule in such a ~ay that, although it is ade~uately f;xed on the opening of the tubule~ at the same time ;t also leaves a part of the opening free, in order to allou the water vapor to escape. Furthermore, the closin~ plug already put in place dur;ng drying makes it possible that subsequently the tubule opening can rapidly be closed completeLy. This is important in order to prevent uater vapor from re-entering the pack-aging tubule after drying.
In principle, a single recèss on the periphery of the closing plug su~fices for the said purpose. However, for centering the closing plug in the packaging tubule and for more rapid gas transport during drying, ;t is advantageous ~hen several recesses are distributed over the periphery of the plug.
Further deve~opments of the in~ention are indic-ated in the sub-rlaims~
It is expedient when the packaging tubule has a conical ~r~ns~tion from the length section of larger external d;ameter to the length sect;on of smaller e~ter-nal diameter. This shaping avoids sharp edges which could damage the applicator by friction.
According to a further development of the pack-aging tubule~ the edge of its opening is flanged ou~uards.
On the one hand, this prov;des greater stab;l;ty of the packaging tubule in the zone of its opening and, on the ~2~37~

-- ~o --other hand, the upper edge of the tubule is ~idened, ~hereby a risk of injury during handling of the packaging tubuLe ;s avoided. Moreover, improved sealing of the tubule closure is thus achieved. It has proved to be advantageous ~hen the external diameter at the flanged edge is smaller than in that length sect;on of the pack-ag;ng tubule where the larger external diameter applies.
As a result, for space-saving~ the packaging tubules can be placed close together until their walLs are in mutual contact, without this being impeded by the flanged edge.
According to a further embodiment, the peripheral surface of the closing plug, ~hich comes into contact ~ith the internal surface of the packag;ng tubule, has at least one project;on at a distance of about one quar-ter of its length9 starting from the end facing the tubule. This pro~ection makes it easier to position the closing plug on the packaging tubule before dryins. The project;on acts as a stop oppos;te the edge of the open;ng, ~hen the plug is pressed only partially into the tubule, so that 3 part of the opening remains free.
In most cases, the size of the packaging ~ubule is such that the clistance between the inner end face of the closing plug and the bottom of the packaging tubule is slightly larger than the length of a tampon appl;cator kno~n per se and cons;sting of t~o sleeves ~hich are telescopically displaceable in one another. This makes it possible to accommodate a diagnostic tampon, including the associated applicator~ in the packag;ng tubule~

~2~37~

According to a further advantageous embodiment, a depression is provided in the bottom of the packaging tubule, the d;ameter of the depress;on being slightly larger than the external d;ameter of the rear end of the tampon appl;cator to be packaged. In this uay, the rear end of the appl;cator ;s also centered ;n the packaging tubule so that, ;n ;nteract;on with the smaller ;nternal d;ameter of the packaging tubule ;n the length section facing the opening, ~he applicator is ax1ally a~;gned ;n the tubule~ This makes it even more certain that the appl;cator, and hence the tampon located therein, wilL
assume the correct position for the spraying-on of the solut;on of art;ve ;ngredient and wiLl be subjected to uniform cooling~
~ t is advantageous when the packag;ng tubule con-s;sts of a metal of h;gh thermalL conduct;v;ty, for ex-ample of aLuminumD In this case, rap;d heat transfer bet~een the packag;ng tubules is ensured.
The invention is expLained below by reference to lllustrat;ve embod;ments represented d;agrammatically in the drawing ir, ~hlch:
Figure 1 shows parts vf an enlarged long;tud;nal sect;on through a first embod;ment of the packaging tubule;
Figure 2 sho~s an enlargement of the detail A
in Figure 1;
Figure 3 shows an enlargement of the detail in Figure 1;
Figure 4 shows an enlarged side view of a closing ~Z~37~

plug for the packaging tubule according to Figure 1;
F;gure 5 sho~s an enlarged end v;e~ of the under-side of the closing plug according to Figure 4;
Figure 6 sho~s a longitudinal section through a packag;ng tubule according to Figure 1 and through a tampon appLicator, located therein, ~ith a tampon, the closing plug being placed on only partially and being sho~n in side view; and Figure 7 sho~s a longitudinal section similar to that of Figure 6~ ;ncluding a closing plug fully in place, and with a depression ;n the botto~ of the packaging tubule.
A packagin~ tubule 1 consisting, ~or example, of aluminum has a bottom 2, a wall 3 with length sections 3a, 3b and 3c, and an opening 4 having an edge 5 ~hich ;s flanged outwards. The cross-section of the packaging tubule 1 is circular-cylindrical over its entire length.
In the length section 3a, the external diameter of the packaging tubule 1 is greater than in the length section 3c and at the flanged edge 5. In the length sect10n 3b~ the external diameter of the packaging tub-ule 1 narr~s conically up~ards. Overall, this gives a bottle~like shape of the packaging tubule 1.
DetaiL A in Figure 1 is shown enlarged in F;gure 2 and illustrates that the edge 5 is flanged ou~-~ards ;n such a way that, in cross-section, it has an approximately circular curvature and the cut edge 6 bears aga;nst the wall 3 on the outside thereof. As a result, a risk of ;njury due to the cut edge 6 is precluded.

76g~

Detail B in Figure 1 is shown enlarged in Figure 3. Th;s shous that the bottom 2 is thicker than the wa~L ~. Moreover~ the major parts of the inner surface 2a and the outer surface 2b of the bottom 2 are arranged perpendicular to the ~all 3. The inner surface Za rises con;cally to~ards the ~all 3 only ;n a bottom section 2c immed;ately adjoining the wall 3, ~hilst the outer sur-face Zb merges into the ~all 3 as a resuLt of rounding.
~he inner surface 2a extending con;cally in the bottom section Zc forms an angle 7 of about 10~ with the horizon-tal.
The length of the section 3a is, for example, 110 mm, the length of the section 3b is, for e~ample, 10 mm and the length of the section 3c is~ for example, 26 mm. The thickness of the bottom 1 is, for example, about 0.6 to 1 mm, and the thickness of the wail 3 is, for example, about 0~23 mm in the length section 3a and~
for example, about 0.28 mm in the length section 3c.
Suitable external diameters are~ for example,

2~ 22 mm ;n the length sect;on 3a, for example 16 mm in the length section 3c and, for example, 18 mm at the flanged edge 5. The height of the flanged edge 5 can, for ex-ample, be 1.2 mm.
The abovementioned d;mensions can, however, be exceeded or reduced, depend;ng on the intended use of the packaging tubule and the nature of its material, and as a function of the nature and shape of the object to be packaged.
For sealing the opening 4, a closing plug 8 of

3~6~

- ~4 -an elast;c mater1aL, for example soft rubber, is pro-vided~ The closing plug 8 sho~n in Figure 4 has a disk-shaped gripp;ng part 9 ~;th an outer end face 10. The diameter of the gripp;ng part 9 is greater than the external diameter of the seal;ng part 11, located belo~, ~ith an inner end face 12.
Three recesses 13 are prov;ded on three peri~
pheral sect;ons of the sealing part 11, wh;ch acdjoin the end face 12 and are symmetrically distributed.
From Figure 5, which is a plan vie~ of the inner end face 12, it can be seen that the boundary surface of each recess 13 has a curvature which is convex reLat;ve to ~he axis of the closing plug. In addit;on~ Figures 4 and 5 sho~ that the boundary surfaces 14 extend parallel to the axis of the closing p~ug 8. As a result of this design, that part of the closing plug 8 ~h;ch faces the packaging tubule 1 and wh;ch extends over approx;mately half the ~ength of the plug, is formed in the shape of three r1bs.
The recesses 13 approach the axis of the closing plug 8 so closely that the inner end face 12 ;s essen-tially formed only by three narro~ surface sections 12a, 12b~ 12c which overlap on the axis of the closing plug 8 and extend radlally outwards from there, the longitudinal axes of two adjacent surface sections 12a, 12b~ 12c form-ing an angle of 1Z0.
On the periphery of the seal;ng part 11, projec~
tions 23 are provided at the height of the recesses 13 which projections serve as stops opposite the flanged ~0376~

edge 5, when the cLosing plug 8 is to be pressed only partially into the packaging tubule 1~
The trans;tion ~rom the peripheraL surface of the sealing part 11 to the end face 12 ;s conically chamfered, forming edge surfaces Z4, in order to facil-itate the insertion of the closing plug 8 into the pack-aging tubule 1~
~ Figures 6 and 7 sho~ the arrangement of a tampon applicator 15, in ~hiçh a tampon 16 is located, ;n the packaging tubu~e 1.
The applicator 15 consists of an introduction sleeve 17 and an ejectiorl sleeve 18 ~hich is telescopic-ally ;nserted into the latter and has a some~hat smaller diameterr In the region ~here the introduction sleeve 17 and the eJeCtion sleeve l~ overlap~ the t~o sleeves 17, 18 are prov;ded ~;th a punched nick 19. As a result, a tongue 20 is formed in the wall of the introduction sleeve 17, ~hich tongue projects into the punched nick 19 in the ejection sleeve 18 and thus prevents the ejection sleeve 18 from inadvertently slid;ng out of the intro-duction sleeve 17O
Ho~ever~ this locking can also be realized in a different ~ay~ for example by a peripheral groove on the ejection sleeve 18 and an internal bead on the intro-duct;on sleeve 179 or vice versa. There is then a mutual fix;ng of the two sleeves 17, 18, similar to a snap connection.
The tampon 16 is arranged ;n the ;ntroduction s~eeve 17 in such a way that the introduction end 17a of ~376~

the introduction sleeve 17 projects beyond the ;ntro-duction end 16a of the tampon 16 and thus forms a free space 21 at the introduct;on end 17a of ~he introduct;on sleeve 17. This free space 21 serves to receive the solut;on of active ;ngredient which is rapidly sprayed on at th;s point, ~hen an active ingredient is appl1ed to the ;ntroduction end 16a of the tampon 16, and ~hich requires a l;tt'e extra time for penetrating into the tampon 16. The space 21 has a capac;ty of about 3 ml 10 of so lution.
In order to prevent a part of the said solution, ~hile it is present in the space 21 and also later, or of the active ingredient from migrating away into the ~all of the introduction sleeve ~7 and hence being lost from ~he tampon, the inner ~all of the introduction sleeve 17 can be coated with an ;mpermeable loaterial, for exampLe uith a silicone~ a ~ax, a plastic layer or film, such as a PVDC film, or an aluminum foil.
The ~ithdrawal cord 22 of the tampon 16 extends through the ejection sleeve 18.
In Figure 6, the closing plug 8 ;s shown not in longitudinal section, but in side vie~, ;n order to lllustrate the mode of action of the projections 23.
When, after a solution of active ingredient has been applied to the tampon 16, it ;s desired to press the clos;ng plug 8 init;ally only partially into the open-ing 4 of the packaging tubule 1, the projections 23 ac~
as stops opposite the flanged edge S ~hich ;s shown as a broken line in Figure 6. In this position of the 0376~

Glosing plug 8, a flo~ channel 25 remains free, due to the recesses 13, bet~een the interior of the packaging tubule 1 and its outer surroundings. This is necessary wh;le the packaging tubule, together with its contents, is treated in the freeze-drying apparatus. After the end of the drying process, the closing plug 8 can be pressed into the packaging tubule 1 until the gripping part 9 str;kes the flanged edge 5.
Figure 7 largely corresponds to F;gure 6. In Figure 7, ho~ever, the closing plug 8 is sho~n in the closed posit;on and in long;tud;nal sect;on.
Additionally, the packaging tubule 1 according to Figure 7 has a depression 26 in the bottom 2, the d;ameter of the depress;on be;ncg somewhat larger than the external diameter of the rear end 18a, located therein, of the ejection sleeve 18. In th;s way, the rear end of the tampon applicats~r 15 is centered ;n the packaging tubule 1 and thus is, on the one hand, protPc-ted from radial displacement at th;s end and, on the other hand, ax;ally aligned relative to an ;njection needle which is not sho~n and by means of ~h;ch a solu-tion of act;ve ingredient is sprayed onto the tampon 10.
The procedure ~hen using the packaging tubule 1 canO for example, be as follo~s:
The applicator 15 containing the tampon 16 is placed into the uprlght packaging tubule 1 in such a ~ay that the introduction end of the tampon faces the open-iny ~ of the packag;ng tubule 1. Us;ng an automatically operated fill;ng dev;ce~ about 2 ~l of a solution of ~ Ot376~

active ingredient are then sprayed by means of an injec-t;on needle into the free space Z1. Subsequently, the closing plug 8 is partiaLly pressed into the open;ng 4 of the packaging tubule 1, as sho~n ;n Figure ~. A multi-plicity of packaging tubules 1 ~hich have been prepared ;n this ~ay and are placed close to one another ~ith mutual contact, are introduced into a freeze-drying appar-atus. The mutual contact of the packaging tubules 1 en-sures rapid cooling of the tubules and their contents.
Due to the vacuum app~ied, the solvPnt, for example water, of the solution of act;ve ingredient vaporizesfrom the tampon 16 and escapes from the packaging tubule 1 via the recesses 13 in the closing plug 8. After the drying process has been completed, the closing plugs 8 are each pressed into the packag;ng tubules 1 until seal-ing closure is obtained~
Taking an overall vieu, the packaging tubule 1 facilitates the app~icat;on of an act;ve ;ngred;ent to the tampon 16~ reduces the costs of dry;ng the contents of the tubule and, due to the exclusion of mo;stureO a;r and light, ensures a long storage life of the packaged tampon 16 up to the time when it is used for diagnost;c or therapeutic purposes.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. In a packaging tubule having an opening, a closing plug and an external diameter which, in a length section adjoining the opening of the packaging tubule, is smaller than in the remaining length section, the improvement wherein:
a) the remaining length section extends from the bottom up to more than about three quarters of the length of the packaging tubule;
b) the internal diameter of the length section adjoining the opening is slightly larger than the external diameter of the material to be packaged, and c) the closing plug has at least one recess on the periphery of an inner end facing the packaging tubule.

2. A packaging tubule as claimed in claim 1, which comprises an intermediate length section defining a conical transition between a length section of larger external diameter and the length section of smaller external diameter.

3. A packaging tubule as claimed in claim 2, which comprises an opening edge which is flanged outwardly.

4. A packaging tubule as claimed in claim 3, wherein the external diameter of the flanged edge is smaller than that of the length section of larger external diameter.

5. A packaging tubule as claimed in claim 1, wherein the peripheral surface of the closing plug, which comes into contact with the internal surface of the tubule, has at least one projection at a distance of about one quarter of its length, starting from the inner end facing the packaging tubule.

6. A packaging tubule as claimed in claim 5, wherein the distance between the inner end face of the closing plug and the bottom of the packaging tubule is slightly larger than the length of the material to be packaged.

7. A packaging tubule as claimed in claim 6, wherein the bottom is provided with a centering device for the material to be packaged.

8. A packaging tubule as claimed in claim 7, wherein the bottom has a depression, the diameter of which is slightly larger than the external diameter of an end of the material to be packaged.

9. A packaging tubule as claimed in claim 1, which consists of a metal of high thermal conductivity.