DE1704397A1 - Bags, especially for medical purposes, and processes for their manufacture - Google Patents

Description

Bags, in particular for medical purposes, and methods for its Manufacture The invention relates to a pouch, particularly for medical purposes Purposes, and a process for its manufacture. In particular, it relates on a bag that can be pressurized on the inside, which is primarily for one-time use Intended for use and that includes a check valve that operates in a new way is made, and also to an outlet for emptying the bag, which is attached to this is fastened by means of a new type of entanglement. The invention also relates to a novel facility for making these items.

The subject of the invention is; among other things a medical device in the form of a bag or container for gases or liquids that is suitable for this is to apply enemas to patients in hospitals, mainly for is intended for single use. This device according to the invention is inexpensive manufacture and includes an inlet check valve or the like, through which the bag Illit one. suitable liquid or solution or with a gaseous one Medium can be filled to be applied to the patient. This check valve prevents liquid from leaking at the filling opening; the bag can So with the patient on a bed, chair or be placed, and one inde of a hose formed for introducing the edication liquid Catheter can be inserted into the patient's body.

When applying an enema, in the vicinity of the patient further devices and vessels must be in front, and it is a particular advantage of the present invention because # the bag can be placed next to the patient while the @ilfsperson inserts the catheter and brings other barley in place.

Another advantageous feature of the present invention is that # the catheter can be provided with such a small opening that # this only allow a small flow rate per unit of time. Here the catheter inserted into the patient's body and the pouch under the patient's body be placed; the pressure exerted by the patient's body then pushes the fluid into the patient's body. The medication fluid is brought to body temperature were used because they exchange heat during this long-term application pefinds with the patient's body.

The subject matter of the invention can be carried out with relatively laborious process steps Getting produced. These @ measure the success of different subunits, which danac @ are joined together to form an inlet # return valve. A Another advantage is the new-like connection with an outlet hose in a new type of machine, with which the finished bag with an outlet hose can be connected from suitable plastic material, the same with the The hose to be connected to the wall parts of the bag is hot-sealable (heat-weldable).

The invention provides a device with a Kü @ se @ lag valve, weleaes contains edges that are @ ei @ siegelpar and furthermore cooperating edges contains, @that are not sealed, so that # a valve is formed in a housing for this purpose will.

Furthermore, you get a device made of plastic, on which in uin. '. R tit: u.t L tiI iiLO LJ nc: ii1d lii ttj .t) i1, .i e ü & L 1j'f attached i @ t. This Locking is fluid @ @@ i @@ serves @@ @@@@@ Plastic foil attached. The device can be pressurized and is suitable for taking medication Pressure for predetermined times and possibly with the body temperature of the To apply to the patient.

Further details and advantageous developments of the invention result from what is described below and shown in the drawing Embodiment.

It shows: FIG. 1 a view of a container according to the invention or pouch in a ready-to-use position; the container is expanded and filled Fig. 2 is a side view of the container, Fig. 3 is a longitudinal section the lines 3-3 in Fig. 2, Fig. 4 is a view similar to that of Fig. 3, at However, the @ ücks @ lag valve is shown in a position where there is liquid retains medium in the container, ig. 5 shows a section along the line 5-5 of FIG. 2, which shows the handle portion of the container, FIG. 6 is an enlarged section along the line 66 of FIGS. 2, 7, a view of a device for manufacturing the one in Wig. 6 connection point shown in detail; the facility is open shown, and the inserted plastic parts are shown before being connected, FIG. 8 is a view similar to that of FIG. 7, but in which the arrangement from FIG Hose and foils after completion of the connection process is shown, and Fig. 9 e-n Diagrain: ii of electrical impulses such as those used to connect a hose can be used with a container.

Fig. 1 shows a medical container or pouch 10, the @it can be filled with a suitable liquid medium.

The container 1 is connected to an outlet hose 11, the end of which is shown enlarged. This end is a @ rounded and forms a cataeter 12, iii which a hole 15 of a suitable, pre-determined major @@ flurkepa @ ität is formed is.

The catheter 12 can be inserted into a patient while the container 10 on a sheet 14, e.g. Table or chair, lies. As long as the catheter 12 is over the plane of the upper edge of the container 10, nothing can flow out of it. According to the invention, a wax or the like which is soluble at body temperature @ can also be used. in the opening 15 of the catheter 12 is introduced to prevent it from flowing out, before the item is put into use; the wax then melts through the Body temperature of the patient.

Fig. 2 shows a side view of the container. Sin pair the container Forming foils 16, 17, also referred to below as cover foils, are heat-sealed 18, at the top in the view according to FIG. 2, heat seals 19 at the left end and heat seals 20 connected at the lower end to a pressurizable container or to form bags. (Hot seals are produced by the action of heat Welds) A handle part 22 is made by fieißsiegelungen 23, 24 and a Heat seal 25 formed, the recesses 26 (see. Fig. 5) surrounded by all sheets of plastic go.

J3 in part 28 of container or bag 1G is in the upper right Part of Fig. 2 shown. This part forms a valve and includes neiss-sealed ones Valve edge hems 29 and 30 on the upper and lower sides of the valve part 28. An end cap, which also defines a valve opening, is provided by a seal 31 and a seal 32 are formed, which are attached to the foils 17 and 16, respectively.

A check valve is made up of a pair of essentially similar ones formed material foils 34 and 35 formed. As shown, the slide is 34 connected at its right edge to the heat sealing edge 32 of the film 16. The lower valve part 35 is connected to the film 17 by the heat-sealed edge 31. All four foils are then made in a second step of the manufacturing process Heat-sealed along edge hems 29 and 30 and thus form the inlet check valve 28 for the bag 10. As indicated in FIG. 2, the heat-sealed end 31 through the fingers of a user in the dashed line Layer 31a to be sufficiently separated from the heat-sealed end, which is located in the position 32a drawn in dashed lines. So can the bag 10 with a corresponding drug or the like. be filled.

As can be seen, the heat seals 31 and 32 are in the longitudinal direction of the bag slightly apart so that the parts making up the bag are not identical are. However, this is essential, and the parts could also be identical, the seals 31 and 32 then lying one above the other. However, such would be Bag not as easy to open as the bag shown in the drawings. The plastic material preferably used has a suitable surface affinity, to keep valve 28 closed until manually opened for use. mig. 4 shows the valve section 28 on an enlarged scale, specifically when it is filled State. (The filling quantity can be determined from the cubic centimeter information 38 shown in FIG The foils 34 and 35 forming the valve are normally read dur @@ affinity and also held together by the pressure exerted by the contents of the bag is exercised. The bag can withstand considerable pressures, e.g. when it is under the Body of a patient is placed to drugs or the like for a long time. to feed as already indicated above; the latter can be achieved by an opening 15 for lower flow rate in the catheter 12 (Fig. 1) provides, at least the non-return valve 28 forming foils 34, 35 are made of a suitable Made of plastic material that has a surface affinity. For example is polyvinylchloride of the thickness "14-gauge" with success for the production of the here described Valve has been used.

The material for the valve parts 34 and 35 preferably has a smooth @zw. glossy side and a relatively rougher or matt side. The shiny ones Pages have a greater affinity to each other and therefore have a tendency to stick together (Conesion). This characteristic of adhesion does not appear on the matt sides in the same way Dimensions as on the shiny sides.

In the embodiment shown, the adjacent Sides between the parts 34 and 35 forming the valve are the shiny sides of the material. The inner sides of the films 16 and 17 forming the bag can the matte sides may be of thicker material, such as starch polyvinyl chloride "8-gauge". The valve parts 34 and 35 will then have less tendency to stockpile to stick to the foils 16 and 17 of the bag; they are much more likely to be the tendency have to stick together. Such plastic material is available in Almond though from Somers Plastic Company, Industrial Park, l.ew Jersey, V.St.A., under the catalog designation "German Roller Patent". However, other plastics of a similar nature are also used Illit a glossy and a matte side, where the glossy side is a shows greater surface affinity than the matte Seie used to make the pouch and the valve deemed appropriate.

Fig. 5 shows the handle part 22 in section and shows the four foil layers 16, 17, 34 and 35 with essentially congruent perforated parts 26, which are dimensioned so that # they can accommodate two or three fingers of a user. It should be pointed out that the upper part 4C of the recess 26 is arranged in this way is because the bag hangs essentially vertically when it is hung on a maken, in order to completely empty its contents through the tube 11.

For some applications it is desirable that the bag is in different is suspended at heights so that the contents of the bag can be emptied through the catheter 15 according to the effect of gravity is best illustrated. If the bag is a jedoci $ gaseous $ medicinal product or the like. contains, of course, must be in each ball from the outside Pressure is applied to the surface of the bag to force the gas through the opening 15 in the Katneter 12.

The bag 10 is preferably made in the following manner: As a first step, a film 16 is attached to the edge 32 with one belonging to the valve Foil 34 sealed. The second film 17 is at the edge 31 with the second to Valve troublesome Folis 35 slegelt. The files are then placed on top of one another da # matching @ parts matching together, and the @ e @@ sie @ el @@ hte (sweat @@@ @te) 18, 19, 2ö, 2), 24, 25, 29 and 30 are in a single Tool made to complete the assembly of the bag and inlet valve.

Thereafter, the other end of the bag 10 is attached to the end of an ochlaucils 11 applied; a tool makes a hole 42 in the bottom of the bag, and this one Parts are compressed and sealed together in an entanglement, the following is explained. The resulting product is a bag with two openings, viz a filler opening in the form of an inlet # check valve 28 and an outlet # opening with a connection to the hose 11 for emptying the bag.

The bag made in this way consists of relatively cheap parts and can be easily manufactured with devices suitable for mass production are. The cost of the bag is so low that it can be used as a disposable bag can. Therefore, this pressurized bag can only handle one Used and thrown away after treatment. It is not anymore necessary to sterilize and the like with the methods customary up to now, which is expensive and takes time. However, such a bag does not have to be thrown away after use, but can be used multiple times by one patient.

Method and device for heating (welding) hose and film Fig. 6 shows the tube 11 connected to a part of the bag 10, namely all of the outer surface of the hole 42 in the sheet material 44 and the inner, spread surface of the hose 11. Din inner, outwardly flared end 45 of the hose 11 is enlarged to an angle of about 450. In this position the contact surface 42 is enlarged and the cross section of the hose becomes relatively thin-walled at end 45a compared to the normal thickness of the hose. Similarly, the hole 42 in the film 44 is also elongated, elongated and compressed, and nei this extension there is a relative movement and Area enlargement along surface 44. Magnetic excitation heat and tool pressure the conical surface 45 is shaped to create a strong, intimately connected and gas and to produce a liquid-tight seal or weld on the surfaces 42 and 45.

Figure 7 shows two mating magnetically conductive shapes 50, 51. The mold 50 is connected in a suitable manner to a pressure ram 52, which is driven by a hydraulic motor 54, which the mold 50 down in the position shown in FIG. 8 and back again to the position shown in FIG can move. This movement process runs for every welded connection or seal of the tube 11 with the film material 44 of the indicated with dashed lines Bag 10.

In the position shown in Fig. 7, the hose 11 is in a Transversal groove 56 laid out of semicircular cross-section, located on the upper Side of the shape 51 is located.

A corresponding, semicircular groove 57 in the upper mold 50 cooperates with the groove 56 to the hose 11 by friction between them loud to hold on. The sunde 45 of the hose 11 extends with a predetermined Long in conical openings 59 and 60, each with a 45 ° opening angle, which are in the upper mold 50 and the lower mold 51 are provided. The hole 42 is through the sunde of a punch 62 on the end of a magnetic mandrel 63 into the end of the Foil material 46 pricked and in position relative to the end 45 of the hose 11 brought. The stamp 62 can be made of a phenolic resin, for example. The mandrel 63 is made of a magnetic material and is pressed in until a on it trained shoulder 67 presses against the hose end 45 and it into the in Fig. 6 pressed apart. The parts 42 and 45 result a small gap for the magnetic flux (air gap).

Fig. 8 shows the magnetically conductive standards 50 and 51 in intimate Contact each other to create a sufficient path for a flow to flow to the conical Create areas 59 and 60.

The magnetic mandrel 63 is in the position shown and has a surface 72 which bears against a pole 74 of an electromagnet 75. Another Pole 76 of the sheet magnet 75 is magnetically conductive with the lower one Form 51 connected, which in turn, as described above, with the upper form 50 magnetically is coupled.

A magnetic coil 78 is made up of lines 79 from an equi £ 4-current and hi-source 80, which are connected to a network 82 karin. Flows a direct current through the lines 79, the magnetic coil 78 polarizes the eld so that the flow passes through the gap 70 only in one direction.

RF excitation of the winding 78 results in high-frequency magnetic ones Vibrations in gap 70.

Certain vinyl plastics that make up Pouch 10 and the Hose 11 are manufactured, have the properties because # their molecular domains (domains) usually arranged with statically distributed magnetic polarity are. Under the action of a magnetic rock, the substances in the bag 1G and of the tube 11 with a gap 70 and polarized with respect to one another, This working section is shown in FIG. 9 by a DC voltage 85 above a zero line 86 shown.

According to a predetermined polarization time of the domains and the Molecular structure of the contacting surfaces 42 and 45 of the bag 10 or of the hose 11, an HF voltage of about 27 MEz is applied to the gap 70 and through the magnetic circuit from poles 74 and 76 to the magnetic parts 70, 71, 72 of molds 50 and 51 and mandrel 63. In Figure 9 the H2 flow is through Lines 88 indicated. It flows for a time suitable for heating of the plastic material in gap 70. Different material thicknesses require different long periods of high-frequency heating to achieve the final, desired weld or to achieve sealing. The substances are therefore heated by the SF current. after this the materials in gap 70 get the right warmth and tightness due to the magnetic excitation Connection, the magnetic field is switched back to direct current, to rearrange the magnetic domains.

This is illustrated by line 90 in FIG. After the renewed Arranging the domains, the fabrics 42 and 45 form a weld, the direct current reverses returns to the value zero (zero line 86), so the domnnsu return in statistical distributed Lay back and the weld between fabrics 42 and 45 is complete. The pore 50, 51 and the mandrel 6S are removed to take out the finished bag to be able to.

Claims (21)

Patent claims foils 1. Bags made of nei # sealable; in particular for medical purposes, characterized in that a pair of first foils (34, 35) of a similar shape and a first. predetermined size is provided by each of which has a first section of a predetermined shape and an edge (31,32) comprises that a pair of cover sheets (1b, 17) of a predetermined size are also provided are larger than the first foils, each of these cover foils being one having second portion which is substantially in the shape of the first portion of the first foils coincides with the fact that all of them have heat-sealed seams (29,30,31,32) Connect foils with one another, with the first foils (34,35> between the cover foils (16,17) to form a bag (10) which is an inlet check valve (28) between the first sections and the edges (31,32). 2, bag according to claim 1, characterized in that it has an outlet with a Leitng (11), one end (12) of which by means of a sealing surface (45) is connected to at least one of the cover films (34, 35). 3. Bag according to claim 2, characterized in that the inlet # check valve (28) at one end of the bag (io) and the outlet (11) from this valve (28) in Distance is arranged. 4. Bag according to claim 3, characterized in that the outlet (11) at an end (46) of the bag opposite the inlet check valve (28) (10) is arranged. 5. Bag according to one or more of the preceding claims, characterized in that each first film (34,35) has two valve edges and that all foils with the exception of one valve karite each of the first two poles (34,35) are connected to one another by heat-sealed seams (29,30,31,32). 6. Bag according to claim 5, characterized in that the outlet as a relatively thick-walled plastic tube (11), which is formed to the outside enlarged, thinner end (45a), and that the sealing surface (45) between At least one of the cover foils has this sund (45a) and a complementary surface (42) (16,17) is provided. 7. Bag according to one or more of the preceding claims, characterized in that it is used as a pressure-tight container (10) for medical purposes is trained. 8. Valve, especially for a bag after one or more of claims 1 to 7, characterized in that it is made of heat-sealable plastic films consists in that two first foils (34, 35) serving as valve parts are of a similar shape and a first predetermined size, each of which is a first Section of predetermined shape and having an edge that further comprises two as Foils (16, 17) of a predetermined size serving as the valve housing are provided, which are larger than the first foils, each of which has a first part, which essentially corresponds to the shape of the first section and further a second part which extends beyond the edge (32) of the first foils, that hot sealing seams (29,30,31,32) are provided to attach these foils to predetermined To connect surfaces with each other, with the parts serving as a valve between the parts serving as ventilator housings are sealed and the ifli essential matching sections and parts are in alignment and the edges are unsealed are to form a capillary, sealable check valve (28). 9. Valve according to claim 8, characterized in that the valve housing serving foils (16,17) are designed as a bag (10) and that in this bag and an outlet is provided in this bag at a distance from the check valve (28) is. 10. A method for producing a valve according to claims 8 or 9, characterized in that a Y-valve part (34) longitudinally as the first sub-unit a valve edge (32) sealed to a part (16) serving as a valve housing is that as a second sub-unit, a second valve part (35) to a second as Valve housing serving part (17) is sealed to a corresponding valve edge (31), and that these sub-units run along at least two others, the Valve (28) delimiting edges are sealed, with these edges at the ends the one valve edge (32) and the corresponding valve edge (31) run and the fourth edges of the valve work together with one another. 11. A method of making a pressurizable bag according to one or more of claims 1 to 7 and according to claim 10, characterized in that that serving as valve housing parts (16,17) on the outlet side of the check valve (28) are made much larger than required for the valve and that these parts (16, 17) essentially along their entire edges (18, 19, 20) tightly are connected to each other. 12. The method according to claim 1G, characterized in that for manufacturing an outlet, a part of the bag is provided with a recess (42) and into the End of the heat-sealable tube (11) is inserted and that this bag part and the hose can be exposed to plastic under the action of pressure and heat Flow and glue the hose (11) and this part. 13. Bag according to one or more of claims 1 to 7, characterized gekellnzeich that the outlet has a heat-sealable plastic film in which a recess (42) of a certain size is provided, and that a heat-sealable Plastic tube (11) is provided, one end (45a) of which this recess (42) surrounds, this end and the film material surrounding the recess (42) being plastic are deformed and sealed together. 14. Bag according to claim 13, characterized in that the end of the hose (11) forms an angle with the longitudinal axis of the hose. 15. Bag according to claim 14, characterized in that the angle is about 450, 16. Device for magnetic sealing of plastic materials, characterized in that at least two relatively movable magnetic Molded parts (50,51,63) are provided which form a gap (70) in which substances be held for sealing, inid that an electromagnetic device (78,80) to influence the magnetic domains in these substances is provided to a To effect sealing between them. 17. Device according to claim 16, characterized in that the Device (78, 80) for influencing the magnetic domains, a high-frequency generator having. 18. Device according to claim 17, characterized in that the Device (78,80) has a direct current source. 19. Device according to claim 17, characterized in that the barrel high frequency generator generates a frequency of about 27 MHz. 20. Device according to one or more of claims 16 to 19, characterized in that they have a first and a second movable relative to one another Contains form (50 and 51) with means for holding a tubular, heat-sealable part (11) are formed, each of these shapes with recesses (59,60) is provided, which when the molds engage a first, approximately frustoconical Form an opening, and that a third megnetisoles shaped piece (63) is provided, which can be reciprocated along the axis of the frustoconical opening (69,70) and has a second frustoconical surface (67) which coincides with the frustoconical The opening cooperates and forms a gap (70) with it, in which to be sealed Material can be incorporated. 21. Device according to claim 20, characterized in that the Surfaces of the frustoconical opening (69,7) and the frustoconical surface (67) form an angle of about 45 ° with said axis. Blank page