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Publication numberUS3325031 A
Publication typeGrant
Publication dateJun 13, 1967
Filing dateSep 2, 1965
Priority dateSep 14, 1964
Publication numberUS 3325031 A, US 3325031A, US-A-3325031, US3325031 A, US3325031A
InventorsSingier Jacques Louis Gregoire
Original AssigneeFr Des Lab Labaz Soc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Bottles of flexible material for medicinal products
US 3325031 A
Images(5)
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Description  (OCR text may contain errors)

June 13, 1967 J. L. s. SINGIER 3,325,031

BOTTLES OF FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS Filed Sept. 2, 1965 5 Sheets-Sheet 1 FIG .2

June 13, 1967 J. 1.. 5. SINGIER BOTTLES OF FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS 5 Sheets-Sheet 2 Filed Sept. 2, 1965 FEE Java/5k M 0 0 F 6 l U 0 S M M d June 13, 1967 J. 1.. G. SINGIER 3,325,031

BOTTLES OF FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS Filed Sept. 2, 1965 5 Sheets-Sheet June 13, 1967 5|NG|ER 3,325,031

BOTTLES OF FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS Filed Sept. 2, 1965 5 Sheets-Sheet 4 Ana/wag Jncouas [cu/s Gzeaanes SING/E4? June 13, 1967 sm 3,325,031

BOTTLES OF FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS Filed Sept. 2, 1965 5 Sheets-Sheet 5 v United States Patent C 3,325,031 BOTTLES F FLEXIBLE MATERIAL FOR MEDICINAL PRODUCTS Jacques Louis Gregoire Singier, Sceaux, France, assignor to Societe Francaise des Laboratoires Labaz, Paris, France, a corporation of France Filed Sept. 2, 1965, Ser. No. 484,518 Claims priority, application France, Sept. 14, 1964, 988,028; Feb. 12, 1965, 5,320 20 Claims. (Cl. 2l5--37) The present invention relates to bottles of flexible material intended especially for containing medicinal products, for example for intravenous injection, such as electrolytic or other solutions, plasma substitute solutions, anticoagulant solutions, blood, or plasma and derivatives,

Containers of this kind have already been proposed, in which the flexibility of the material forming the container is exploited to allow the container to assume two different shapes by deformation, corresponding to two different values of internal capacity of this container. An arrangement of this kind makes it possible to reduce the internal volume of residual air in the container, which is a possible source of pollution, whilst providing the possibility at the time of application, of adding to the medicinal base product initially charging the container when the volume of the container is a minimum, any desirable complementary medicinal product, up to a partial or complete filling of the capacity provided by conversion of the container from its shape corresponding to minimum internal volume into its shape corresponding to maximum internal volume.

Despite this advantage, and despite others conferred in particular by the lightness, strength, cost price and safety of the flexible materials available for producing containers of this kind, such containers have not been as successful as could justifiably have been expected. This fact may be attributed, in some cases at least, to lack of stability, to imperfections in sealing, to certain difficulties in production, or else to an unusual appearance and mode of application which disconcert the staff called upon to use these containers.

It is a main object of the present invention to provide a bottle of flexible material of the kind described (for medicinal products in particular), which lacks the shortcomings referred to and has other additional advantages.

According to the invention a bottle of flexible material for medicinal products, of the kind comprising a filler neck arranged to 'be plugged, lateral sides and a base, is characterised in that the sidewalls are joined to each other in a cross-sectional outline of generally polygonal form, and at least one of these sides comprises a deformable area capable of assuming two shapes, one convex towards the outside of the bottle and the other convex towards the inside of the bottle on either side of the median plane of the said side.

A bottle of this kind retains the stability and conventional general appearance of glass bottles in common use for transfusions, whilst offering the advantages specified for bottles of flexible material. In particular, by virtue of the deformation of its sidewall or sidewalls having a deformable area, its internal capacity may assume two different values, the minimum one operative at the time of filling allowing the internal volume above the medicinal product filling the bottle to be reduced, which prevents the dangers of possible deterioration of this product, the maximum one intended when a transfusion is being given, allowing an additional product to be added without straining the sides and without back surge of liquid. Graduations on the bottle make it possible at all times during application to check the volumetric transfusion deliveries. In addition, the polygonal shape of the bottle makes it possible to reduce substantially the storage and conditioning volumes. Further the bottle may be produced easily and economically by extrusion and inflation to maximum volume, for example, from an appropriate synthetic elastomer.

In a preferred form of embodiment, the cross-section of the bottle according to the invention is essentially square, and when the interior of the bottle is at atmospheric pressure, the inwardly convex configuration is unstable, so that the internal volume of the bottle is under negative pressure for as long as the outwardly convex shape has not been established. This eliminates the risk of back surge of liquid, specifically in the case when, owing to clumsy operation, the perforating needle for the addition of the complementary medicinal product were to penetrate into the basic medicinal product itself,

The deformable area of one of the sides may be connected to the rest of the side by a series of concentric rings which are alternately projecting and recessed. An arrangement of this kind facilitates the change from one shape to the other.

According to another feature of the invention, the base of the bottle comprises a device for permitting access to the bottle by perforation, which device may comprise a neck terminating in a head whose diameter is greater than that of the neck. The head may be covered by an elastic cap.

In another embodiment of the invention the base of the bottle may 'be provided with a device for permitting access by perforation to the internal volume of the bottle, which device comprises a self-sealing puncturable joint of resilient material, the said joint being formed with at least one anchoring projection around which the base of the bottle is overmoulded, so that the said joint is imprisoned by the base without any other bonding. The said resilient joint may comprise a body at least partially engaged in the bottle and provided inside the bottle with an annular flange forming the said anchoring projection. Preferably the flange is level with a transverse end face of the device.

This arrangement makes it possible to eliminate the glueing of the resilient joint and, when the transfusion device is withdrawn, prevents the transfusion device from pulling the joint along, as it might occur if the bonding of this latter were to prove inadequate or faulty.

According to another feature of the invention, the body of the joint may be formed as a hollow small cup open towards the outside of the bottle to allow its being held prior to the moulding of the bottle, on a spigot carried by the mould employed for the production of the bottle. This formation permits guiding of the transfusion device and/ or the fitting of an external protection device described hereinafter.

Such a protection device, preferably made of the same material as the bottle, may comprise a body adapted to the form of the said resilient joint for insertion thereinto, the said body being equipped with an annular flange intended to bear externally against the base of the bottle around the said resilient joint so as to be made integral with the said base.

Further, the body of the protection element may be formed as a hollow small cup open towards the outside of the bottle to allow its being held prior to the moulding of the bottle on a spigot carried by the mould employed from the production of the bottle, so that its flange is welded automatically to the base of the bottle during the moulding of the bottle.

Preferably the flange is tapered down peripherally. In simple and economical manner, and in a single operation, one thus obtains a self-sealing device for permitting access by perforation, which device is wholly integral with the 3 base of the bag," perfectly hermetic and protected ex ternally against any contaminating agents.

The filler neck of the bottle according to the invention may receive any kind of plugging device allowing penetration by conventional transfusion devices.

Preferably, according to the invention, the filler neck comprises a neck which terminates in a recessed collar formed by a skirt connected to the neck by an annular supporting area, in combination with a plugging device which comprises, inserted consecutively, a first cup formed by a body joined to a recessed collar complementary respectively to the neck and to the collar of the neck of the bottle for insertion as a push fit into the neck so as to abut against said annular supporting area, a resilient joint inserted as a push fit into the body of the said first cup and of a height at most equal to that of the said body, and a second cup formed by a base joined to a recessed collar complementary to the recessed collar of the first cup for insertion as a push fit into said first cup up to abutment.

By virtue of its shape, a filling neck of this kind facilitates grasping the bottle and the skirts or sleeves consecutively inserted into each other into the neck of the bottle, of the first cup and of the second cup advantageously extending to the same level may be easily and hermetically welded to each other, for example by contact with a metal piece raised to appropriate temperature, along the upper part of these sleeves held in appropriate position. At the same time, the number of the produtcion batch may be imprinted by heat on the base of the upper cup. Plugging and marking may thus be performed advantageously at the same time.

In order that the invention may be more clearly understood some embodiments thereof will now be described, by way of example with reference to the accompanying drawings, in which:

FIGURE 1 shows a view in perspective of a bottle according to the invention,

FIGURE 2 is a longitudinal section of this bottle, shown plugged and with a configuration corresponding to its maximum capacity,

FIGURE 3A illustrates a cross-section along the line IIIIII of FIGURE 2, whereas FIGURE 3B illustrates a similar section of the minimum capacity configuration of the bottle,

FIGURE 4 illustrates to a larger scale an exploded longitudinal section through the neck of the bottle and of the co-operating plugging device,

FIGURE 5 illustrates to different scale, a partial section along the line VV of FIGURE 2,

FIGURE 6 illustrates the welding of the plugging device according to the invention,

FIGURE 7 shows two different part-sections each illustrating embodiment of the plugging device,

FIGURE 8 is a view analogous to FIGURE 2 and illustrates another bottle construction according to the invention,

FIGURE 9 is an enlarged section through a device intended for perforation fitted to the base of the bottle,

FIGURE 10 is similar to FIGURE 9 and illustrates a different device intended for perforation,

FIGURE 11 is a view in section of the base of the bottle showing a different suspension member,

FIGURE 12 is a section through the base of a bottle provided with another kind of device for permitting access to the bottle by perforation,

FIGURES 13 and 14 illustrate diffeernt stages of production of the device of FIGURE 12,

FIGURE 15 is a view analogous to that of FIGURE 12 showing another embodiment in which there is incorporated an element for the external protection of the device intended for perforation,

FIGURES 16 and 17 illustrate different stages of production of the arrangement illustrated in FIGURE 15,

FIGURE 18 is a view in section of another embodiment of the device for permitting access to the bottle by perforation, and

FIGURES 19 and 20 show the consecutive production stages of the device illustrated in FIGURE 18.

Referring to FIGURES 1 to 3 of the drawings, a bottle of flexible material for medicinal products, according to the invention, comprises four analogous sidewalls 10 formed between a filler neck 11 and a supporting base 12. Each side 10 has a deformable area 13, moulded in the form of a half olive, and capable of assuming two different shapes, the one convex towards the outside of the bottle (FIGURE 3A), and the other convex towards the inside of the bottle (FIGURE 3B). These two shapes lie to either side of the median plane of the rest of the side. Advantageously, but not necessarily, only the outwardly directed convex shape is stable when the inside of the bottle is at atmospheric pressure.

The filler neck 11, shown particularly in FIGURE 4, comprises a cylindrical neck 14 joined to the sides 10 by triangular flats 15. The neck 14 terminates in a recessed collar formed by a vertical cylindrical skirt 16 of greater diameter than the neck 14 and joined to the neck by an annular support area 17. According to the invention, such a neck is preferably associated with a plugging device which in succession comprises a first cup 18 inserted as a push fit into the neck of the bottle, and to this end formed by a cylindrical body 19 complementary to the inside of the neck 14, and joined to a recessed collar 20 complementary to the collar 16 of the bottle. The collar 20 is formed by a vertical terminal skirt 21 and an annular support area 27. The plugging device also includes a resilient joint 22 which is a push fit into the body 19 of the first cup and is slightly shorter in height than the body 19, and a second cup 23 inserted as a push fit into the collar 20 of the first cup. To this end the second cup 23 is formed by a base 24 joined to a recessed collar complementary to the interior of the collar 20 of the first cup, that is to say formed by a vertical terminal skirt 26 and an annular support area 28.

The cups 18 and 23 are made of the same material as the bottle and have the function of isolating the resilient joint 22 which is hollow towards the interior of the bottle. The cups 18 and 23 are inserted in each other up to abutment of their corresponding annular support areas 27 and 28, and in this position, the tops of the vertical skirts 21 and 26 of the cups are fiush with and at the same level as the skirt 15 of the neck of the bottle (FIG- URE 2).

The base 24 of the cup 23 comprises a central area 29 of lesser thickness, as also does the cup 18 and the joint 22, for facilitating the perforation of this plugging device by a transfusion needle.

The base 12 of the bottle comprises a recessed surface 30 within a peripheral supporting bead 31 formed by the sides of the bottle. The base is provided with a hanging member such as a handle 32 in the form of a V open towards the bottle and secured to the recessed surface 30 of the base 12 about an axis of symmetry of this surface (FIGURE 5) by joining portions 33 of lesser thickness. This arrangement facilitates the folding down of the handle 32 within the shelter of the bead 31. To this end, the height of the handle 32 may for example be smaller than half the transverse extension of the surface 30. It may be greater however if the handle is capable of being folded.

Instead of a handle, the suspension device may be formed (FIGURE 11) by a strap 63 secured to the centre of the base 12 and provided with an eye 64. At 65 and 66 are formed thinner parts of the strap 63 facilitating the folding of the strap for stowing within the space encircled by the bead 31.

The base is also provided with a device 35 for permitting access to the bottle by perforation, which may be of any kind, but which may also be simply formed, according to the invention (FIGURE 2 and FIGURE 9) by a neck 36 terminating in a head 37 of greater diameter than that of the neck and contingently covered by an elastic cap 38. This device whose height is smaller than that of the bead 31, has the purpose of localizing and facilitating the penetration of a perforating needle.

This bottle is used in the following manner. The bottle is filled with the basic medicinal product and is plugged, with the plugging device described by way of example, while keeping the sidewalls in their convex shape towards the inside of the bottle (FIGURE 3B). In this way, there remains only a negligible residual volume of air above the contents, and the bottle is under negative pressure. The sealing of the plug is assured by welding the different component parts of the plugging device together. This welding may be performed by contact and cooling, by heating in an oxidising flame and moulding of the material in course of fusion, by heating a metal capsule previously placed on the skirts of the neck and upper cup, or more simply (FIGURE 6) by simultaneous contact of a metal part 40 raised to an appropriate temperature, between 308 C. and 600 C. for example, with the upper part of the skirts 16, 21 and 26 positioned appropriately by means of a frame for example. At the same time, the part 40 may advantageously comprise a stud 41 adapted to imprint the number of the production batch by heat on the upper cup 23, for example on the annular area 28 of the cup 23-, or on its base 24.

In use, a complementary medicinal liquid may be introduced by means of a syringe which perforates the plugging device, which plugging device, and specifically the joint 22, reseals itself automatically after withdrawal of the syringe and assures the sealing of the bottle. A product may thus be added to occupy eventually the whole volume provided by the progressive return of the lateral sides to their outwardly convex forms. The bottle advantageously being under negative pressure, there is no back surge of liquid, even if the syringe accidentally penetrates into the liquid volume contained in the bottle.

The bottle is then inverted and suspended by its handle 32, or strap 63, after fitting a transfusion device in the plugging device. The device 35 for access by perforation may then be employed for the fitting of an air bleed to allow the outflow of the contents, or for the addition of a complementary medicinal solution, which addition may thus be made in an advantageously aseptic manner without reversing the bottle and stopping the transfusion.

To check the volumes transfused, the bottle carries two scales of graduations, for example on two corners (FIGURE 1), which graduations correspond respectively to the maximum capacity of the bottle, and to the minimum capacity of the bottle.

It will be appreciated that the shape of the filler neck facilitates its handling, whilst the parallelepipedal form of the bottle, which is perfectly stable, especially when full, considerably facilitates storage and conditioning. In the example described, the bottle has a cross-section which at minimum capacity is substantially square (FIG- URE 3B). This section may evidently be of any shape, and specifically a polygon advantageously assuring satisfactory storage conditions, such as an equilateral triangle, or a hexagon.

In FIGURE 7 there is illustrated another embodiment of the plugging device, according to which this device is capped by a metal capsule 50 which has a central aperture 51 for the passage of perforating needles and syringes, or which may be of the kind, not shown, for tearing off prior to use. As shown at the right-hand side of FIGURE 7, the rim 52 of the aperture 51 of the capsule 50 is folded down against the vertical skirt of the upper cup 23. As has been stated, this metal cap may advantageously assist the welding of the skirts of the bottle.

neck and its plugging device.

In the embodiment illustrated in FIGURE 8, the deformable area 13 of each side 10 is joined to the rest of the side by a series of alternately projecting and recessed concentric rings 55 and 56 respectively. An arrangement of this kind facilitates the deformation of this side.

In FIGURE 10 there is illustrated an alternative embodiment of the perforation device. A resilient joint 60 is situated in a hollow housing 61 formed in the recessed surface 30 of the base 12. The joint 60 may be made solid with this surface, by glueing for example. It may also be covered by a strip 62 made of the same material as the bottle and made integral with the base 12 by ultrasonic welding for example.

Different arrangements for access to the bottle by perforation of the base will now be described with reference to FIGURES 12 to 20.

In the embodiment illustrated in FIGURE 12, the perforation device comprises a joint of resilient material imprisoned by overmoulding of the base 112 of a bottle, which has been shown partially only. This joint 110 has a body 111 engaged inside the bottle and provided with an annular flange 113 forming an extension of its end face, which flange acts as an anchoring projection around which is overmoulded the side 112 as described hereinbelow. The body 111 is hollow to form a cup 114 open towards the outside of the bottle, and the bottom of the cub has an area 115 of lesser thickness to facilitate its perforation.

In FIGURE 13 the mould for the production of the bottle is illustrated partially at 116. The joint 110 is placed on a spigot 117 which may or may not be displaceable. It will be appreciated that during the moulding of the bottle, for example by inflation of an extruded tube, the base 112 of the bottle is over-moulded around the joint 110 as shown in FIGURE 14, and after cooling holds the joint imprisoned without any bonding or weldmg.

In the embodiment illustrated in FIGURE 15, the resilient joint 110 is covered by an external protection element 118 made of the same material as the bottle and comprising a body 119 complementary to the small cup 114 of the joint 110. The body 119 itself is also hollow to form a small cup 120 and has an annular flange 121 tapered progressively in the direction of its periphery. This flange 121 may be made integral with the base 112 by any appropriate method, but according toa preferred method this occurs automatically by welding during the moulding of the bottle, as is shown in FIGURES 16 and 17 which are analogous to FIGURES l3 and 14; In fact, when the tube of plastic material is moulded over the perforation device positioned as shown in FIGURE 16, the temperature of the base 112 is suflicient to produce fusion of the material in the thinned region of the flange 121. Because of the inflation pressure, annular welding occurs of this flange to the base 112.

The alternative embodiment of FIGURES 18 to 20 comprises an elastic joint 122 which may be a simple sealing member in the form of a disc for example, which is inserted between the external protection element 123 and the base 124 of the bottle, the parts 123 and 124 being made of the same material and welded to each other.

The protection element 123 is formed with a small cup 125 for receiving the joint 122, and annular thinned part 126 and a recess 127 for receiving the pin 117. It also has an upper edge 128 which tapers progressively (FIG- URE 19).

The welding of the protection element 123 with the sides of the bottle -112 is performed during the moulding of the bottle by welding together of the tapered areas 126 and 128 as shown in FIGURE 20.

I claim:

1. A bottle of flexible material for medicinal products, of the kind comprising a filler neck arranged to be plugged, a body having lateral sides joined to each other in a cross-sectional outline of generally polygonal form, and a base, characterized in that at least one of these sides has a blister formed integrally from the material of the bottle and bordered by flat portions of the side of the bottle in which it is located, said blister extending away from the plane of said flat portions in a smoothly rounded curve.

2. A bottle according to claim 1, characterized in that the said blister is capable of assuming an inwardly convex position and said inner convex position is unstable when the inside of the bottle is at atmospheric pressure.

3. A bottle according to claim 1, characterized in that said blister of one of the sides is connected to the rest of the side by a series of alternatingly projecting and recessed concentric rings.

4. A bottle according to claim 1, characterized in that the said filler neck comprises a neck which terminates in a recessed collar formed by a skirt connected to the neck by an annular supporting area, in combination with a plugging device which comprises, inserted consecutively, a first cup formed by a body joined to a recessed collar complementary respectively to the neck and to the collar of the neck of the bottle and disposed with a push fit in the neck in abutment against said annular supporting area, a resilient joint disposed with a push fit in the body of the said first cup and of a height at most equal to that of the said body, and a second cup formed by a base joined to a recessed collar complementary to the recessed collar of the first cup and disposed with a push fit in abutting relation in said first cup.

5. A bottle according to claim 4, characterized in that the skirts of the collars of the neck of the bottle, the first cup and the second cup, lie flush at the same level when the first and second cups are inseted into the bottle neck.

6. A bottle according to claim 5, characterized in that the upper sections of the skirts of the neck of the bottle, the first cup and the second cup are heat welded to each other.

7. A bottle according to claim 4, characterized in that the bottom of at least one of the cups comprises a central area of reduced thickness.

8. A bottle according to claim 4, characterized in that the collar of the tiller neck is capped by a metal cap after it has been plugged.

9. A bottle according to claim 8, characterized in that said cap is detachable.

10. A bottle according to claim 8, characterized in that the cap comprises an apertured central region.

11. A bottle according to claim 8, characterized in that the said cap is adapted to be heated to weld the upper sections of the skirts of the neck of the bottle and of the plugging device.

12. A bottle according to claim 10, characterized in that the edge of the apertured central region of the cap is folded down on to the skirt of the second cup.

13. A bottle according to claim 1, characterized in that the base is provided wtih a device for permitting access by perforation to the internal volume of the.

bottle, which device comprises a self-sealing pucturable joint of resilient material, the said joint being formed with at least one anchoring projection around which the base of the bottle is overmoulded, so that the said joint is imprisoned by the base wthout any other bonding.

14. A bottle according to claim 13, characterized in that the said joint comprises a body at least partially engaged in the bottle and provided inside the bottle with an annular flange forming the said anchoring projection.

15. A bottle according to claim 14, characterized in that the said body of the joint is formed as a hollow small cup open towards the outside of the bottle to allow its being held prior to the moulding of the bottle, on a spigot carried by the mould employed for the production of the bottle.

16. A bottle according to claim 13, characterized in that an external protection element is associated with the puncturable device, the said protection element being made of the same material as the bottle and comprising a body adapted to the form of the said resilient joint for insertion thereinto, the said body being equipped with an annular flange intended to bear externally against the base of the bottle around the said resilient joint so as to be made integral with the said base.

17. A bottle according to claim 16, characterized in that the body of the said protection element is formed as a hollow small cup open towards the outside of the bottle to allow its being held prior to the moulding of the bottle on a spigot carried by the mould employed for the production of the bottle, so that its flange is Welded automatically to the base of the bottle during the moulding of the bottle.

18. A bottle according to claim 16, characterized in that the said annular flange of the body of the said protection element is tapered down peripherally.

19. A bottle according to claim 16, characterized in that the said resilient joint is in the form of a sealing pad inserted into the said protection element.

20. A bottle of flexible material for medicinal products, the bottle having a neck and a lower body having a polygonal cross section comprised of a plurality of flat lateral sides, at least one of these sides having a blister formed integrally from the material of the bottle and bordered by flat portions of the side of the bottle in which it is located and extending away from the plane of said flat portions in a smoothly rounded curve.

References Cited UNITED STATES PATENTS 2,642,866 6/1953 Smith .5 XR 2,833,448 5/1958 Lerner. 3,017,883 1/1962 Dickinson l28272 XR 3,030,955 4/1962 Gossett l28272 3,171,412 3/1965 Braun l28272 3,215,299 11/1965 Coanda et al. l28272 XR FOREIGN PATENTS 475,697 11/1952 Italy.

529,635 6/1955 Italy.

609,482 9/1960 Italy.

JOSEPH R. LECLAIR, Primary Examiner.

D. F. NORTON, Assistant Examiner.

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Classifications
U.S. Classification215/247, 215/381, 215/346, 215/382, 425/525, 425/503, 215/358, 215/364, 604/408, 215/DIG.300, 215/232, 222/215, 215/43, 215/399
International ClassificationB29C49/20, B65D23/00, A61J1/00, B29C49/04, B65D39/00, B65D1/02, A61J1/05
Cooperative ClassificationB29C49/04, B29C49/20, B65D39/00, B65D1/0223, B65D39/0076, B65D23/00, B65D2501/0081, Y10S215/03, A61J1/05
European ClassificationB65D39/00, B65D23/00, A61J1/05, B65D39/00G4, B29C49/20, B65D1/02D