WO2001002041A1

WO2001002041A1 - Breather bag and method for the production thereof

Info

Publication number: WO2001002041A1
Application number: PCT/EP2000/006310
Authority: WO
Inventors: Jörg Brokelmann; Mukund Lakhani; Armin Singvogel
Original assignee: Et Elastomer Technik Gmbh
Priority date: 1999-07-06
Filing date: 2000-07-05
Publication date: 2001-01-11
Also published as: DE19931012C1

Abstract

The invention relates to an inflatable breather bag (1) made of an elastic rubber material and comprising a folded bag part (10) having a bag bottom (130) and a bag opening (100) that is located opposite said bottom for letting air in and out. The bag also comprises a sleeve (12) that is connected to the opening (100) having a through lumen (120) for connecting a breathing gas line, whereby the sleeve (12) is made of the same material as the bag part (10) and is integral with said part. A bottom opening (13) is provided in the bag bottom (130) in the area opposite the bag opening (100) that can be closed by means of a closing element (2). The invention also relates to a method for the production of said breather bag.

Description

Resuscitator and method of making the same

The invention relates to an inflatable respiratory bag made of a rubber-elastic material with a folded-in bag part with a bag bottom and a bag opening opposite the bag bottom for the air inlet and outlet and with a sleeve adjoining the bag opening with a continuous lumen for connecting a breathing gas line, and a method for the same production.

Such respiratory bags are used to supply breathing gas to patients when they are unable to breathe automatically.

The usual way of manufacturing such respiratory bags is to immerse a molded core designed according to the inner contour of the desired respiratory bag in a corresponding rubber-elastic material, such as latex, silicone or the like, until the desired wall thickness of the respiratory bag is reached. In this way, a respiratory bag is produced with an inflatable and folded-in bag part which has a bag opening for the air inlet and outlet. Subsequently, it is necessary to demold the bag thus formed, for which purpose the mandrel is removed from the formed via the bag opening

BESTATIGUNGSKQPIE Resuscitator is pulled out. Here, however, the bag opening is overstretched, which results in a high scrap.

Respirator bags made of a rubber-elastic material with two openings for air inlet and air outlet formed on opposite ends of the bag are known in many ways, for which reference is made, for example, to DE 44 09 076 C1 and DE 43 41 746 C1. However, these known respiratory bags have no side folds and no sleeve adjoining the bag opening, so that an appropriately shaped inner core can be dispensed with during manufacture and the loads described above are largely eliminated during removal from the mold. Due to their different design, the respiratory bags constructed in this way cannot replace the functions of a generic respiratory bag with side gussets and only one bag opening for the air inlet and outlet and the sleeve connected to it.

From DE 1 95 1 7857 C 1, a breathing bag of the generic type is known, which can be produced by overmolding a mold core in a closed mold according to the so-called injection molding process and in which, to create sufficient stability, the sleeve adjoining the bag opening, which consists of a suitable stable plastic is produced, is captively connected to the previously injection-molded respiratory bag by an adhesive connection or vulcanization. With this known respiratory bag, however, there is the problem of the bag being overstretched during demolding, i. H. pulling the mandrel out of the resuscitator bag and, in addition, gluing or vulcanizing the sleeve, which is designed as a separate part, into the bag opening represents an additional outlay.

The object of the invention is therefore to propose a resuscitator of the type mentioned at the outset, which, owing to its lower size Loads during the demolding process can be produced with a smaller number of rejects, so that overall the manufacturing expenditure for the respiratory bag according to the invention is reduced.

This object is achieved by designing a respiratory bag in accordance with the characterizing features of patent claim 1.

The object is achieved according to the invention in that the sleeve consists of the same material as the bag part and is integrally formed thereon, and a bottom opening is provided in the bag bottom in the area opposite the bag opening, which can be closed by means of a closure element.

Such a ventilation bag according to the invention can be manufactured in a significantly simplified manner on the one hand by the injection molding process, since the sleeve is already integrally molded onto the bag part, as a result of which a subsequent operation with insertion and gluing or

Vulcanization of a sleeve formed as a separate part is saved.

Furthermore, the bottom opening formed in the bag bottom allows a particularly gentle demolding of a respiratory bag produced in this way, since the demolding of the respiratory bag, i. H. taking the

Mold core can take place via the bottom opening, which prevents overstretching of the bag opening and the sleeve integrally molded onto it. After removal from the mold, the bottom opening can then be closed by means of a suitable closure element.

Advantageous refinements and developments of the invention are specified in claims 2 to 1 1.

A silicone elastomer or a thermoplastic elastomer (TPE) with a Shore hardness A of 20 to 70 is preferably provided as the rubber-elastic material for the bag part and the molded sleeve. Here too is the Design of the respiratory bag according to the invention with a bottom opening opposite the bag opening is particularly advantageous since this allows the use of a continuous mold core which can be fixed twice in the tool at both ends in the area of the sleeve and the bottom opening by means of a mold core bearing. This enables in particular the use of high injection pressures in an injection molding tool, since the mold core remains stable in its fixed position due to the double clamping, which is particularly important for the processing of thermoplastic elastomers.

The closure element for closing the bottom opening of the respiratory bag according to the invention can have, for example, a retaining ring. It is also possible that the closure element has a hose connection which communicates with the interior of the bag part when the closure element is inserted into the bottom opening.

To create sufficient stability, it is proposed that the closure element have a Shore hardness A of 50 to 80, preferably 60 to 70.

In order to facilitate the handling of the respiratory bag according to the invention, it can be provided according to an advantageous development of the invention that the sleeve has an annular bead which projects radially on the outside in the transition area to the bag part.

A sufficient elasticity of the bag part with high stability of the sleeve formed on the bag opening is achieved in that the bag part has a wall thickness of 0.6 to 0.9 mm, preferably 0.7 to 0.8 mm and the transition area between the sleeve and the bag part a wall thickness of 1, 2 to 1, 8 mm and the sleeve has a wall thickness of 5 to 1 2 mm. The corresponding wall thickness profiles of the The respiratory bag according to the invention can be easily adjusted by appropriate shaping of the tool and the mold core which are used for the production of the respiratory bag according to the invention.

In order to enable the breathing bag according to the invention to be easily removed from the mold, the bottom opening has at least the same diameter as the bag opening in the transition area to the sleeve, preferably an at least 5% larger diameter than the bag opening in the transition area to the sleeve.

Furthermore, according to a further advantageous embodiment of the invention, it can be provided that the region of the bag bottom surrounding the bottom opening is formed in a beaded, thickened manner, as a result of which a firm, permanent and gas-tight fit of the closure element closing the bottom opening can be achieved in the ventilation bag according to the invention.

The respiratory bag proposed according to the invention is advantageously produced in one piece from the bag part and sleeve by the injection molding process.

The method proposed in the context of the invention for producing a respiratory bag according to the invention with a folded-in bag part is based on the fact that the respiratory bag is produced in an injection molding process with an injection mold with a mandrel. In order to ensure a particularly gentle demolding of the respiratory bag produced in the injection molding process, it is proposed according to the invention that a mold core is used, the longitudinal axis of which corresponds to the longitudinal axis of the bag and which is supported at both ends, the bearing of the mold core being injected after the respiratory bag has been injection molded and the injection mold removed in the area of the bag bottom is removed and the bottom opening is exposed, and then the breathing bag is pushed from the outside of the bag bottom over the mold core towards the bag opening with a sleeve and the exposed mold core is pulled out of the sleeve in the opposite direction through the compressed ventilation bag and then the bottom opening by means of a closure element is closed.

In this way, a breathing bag is produced by the injection molding process, the sleeve integrally molded onto the bag part during demolding, i.e. H. Pulling out the mandrel does not experience any appreciable stretch, since the demolding of the mandrel from the respiratory bag according to the invention takes place exclusively via the bottom opening arranged in the bag bottom, which is subsequently closed gas-tight by means of a closure element.

The invention is explained in more detail below using an exemplary embodiment in the drawing. Show it:

FIG. 1 a shows a top view of a respiratory bag according to the invention,

1b shows a section through the respiratory bag according to line C-C in FIG. 1a,

FIG. 2 shows an enlarged illustration of a partial section through the sleeve of the respiratory bag according to the invention,

3a shows the side view of a closure element for the respiratory bag according to the invention,

FIG. 3b shows a further embodiment of a closure element for the respiratory bag according to the invention, FIG. 4 shows the production of a respiratory bag according to the invention,

Figure 5 shows the demolding process of the respiratory bag according to the invention during its manufacture.

FIGS. 1 a and 1 b show a respiratory bag for the artificial supply of breathing gas to a patient. The respiratory bag 1 comprises an inflatable bag part 1 0, which is folded in laterally in a manner known per se for better inflation, ie. H. is provided with gussets 1 1 on both sides. At one end of the bag part 1 0 there is provided a bag opening 1 00 serving as an air inlet and outlet opening, to which, in extension thereof, a sleeve 1 2 integrally formed on the bag part 1 0 is connected with a continuous lumen 1 20 surrounded by the sleeve 1 2 ,

On the side of the ventilation bag 1 opposite the bag opening 100, i. H. In the area of the bag bottom 1 30, a bottom opening 1 3 is provided, which for example can have a round or oval cross section and is closed by means of a closure element 2 inserted there.

It is possible in this way to use the breathing bag 1 shown in FIGS. 1 a and 1 b for ventilation of a patient by connecting a breathing gas line (not shown here) to the sleeve 1 2. Then, in accordance with arrow L, the breathing air can flow in a known manner via the lumen 1 20 in the sleeve 1 2 and the bag opening 1 00 into the bag part 10 of the respiratory bag 1 and flow out of it again in the opposite direction.

As can be seen in more detail from the enlarged illustration according to FIG. 2, the sleeve 1 2 is integrally formed on the bag part 1 0 of the respiratory bag, which can be achieved, for example, by manufacturing the Resuscitator bag 1 can be effected by the injection molding process by means of a mold core shown in more detail below and a tool surrounding the mold core.

The sleeve 1 2 has in its interior surrounding the continuous lumen 1 20 towards the outlet opening A a stepped course of the inner wall 1 21, so that conventional breathing gas lines can be connected here. The specific design of the inner wall 1 21 can be adapted, for example, to standardized connections of breathing gas lines in order to be able to connect the breathing bag to other standard parts for breathing gas lines or to be able to combine them.

Due to the integral molding of the sleeve 1 2 to the bag part 1 0, both the bag part 1 0 and the sleeve 1 2 are made of the same rubber-elastic material, for example a silicone elastomer or a thermoplastic elastomer (TPE) with a Shore hardness A of about 38, by appropriate selection of the wall thicknesses of the sleeve wall 1 2a, the transition region 1 23 to the bag part 1 0 and the bag part 1 0 both the necessary stability of the sleeve 1 2 and a good inflatability of the bag part 1 0 can be achieved.

For example, when producing the respiratory bag shown in FIG. 1 from a thermoplastic elastomer (TPE), the sleeve 1 2 can have a stepped wall thickness d3 of about 6 to 10 mm, the transition region 1 23 between the sleeve 1 2 and the bag part 1 0 can have a wall thickness of about 1, 4 mm, which tapers down to the bag part 1 0 on its wall thickness d 1 of about 0.7 mm continuously.

For better handling of the respiratory bag, the sleeve 1 2 in the transition area 1 23 to the bag part 1 0 is also provided with a radially outwardly projecting annular bead 1 22. The closure element 2 for closing the bottom opening 1 3 formed in the bag bottom 1 30 can, according to an embodiment shown in FIG. or can be hung. The closure part 20 advantageously has, on its side facing the bag part 1 0, a protruding insertion projection 21 with which it can be inserted into the bottom opening 1 3 of the respiratory bag 1 and can be welded or vulcanized there, for example, so that a gas-tight closure of the respiratory bag 1 can be effected ,

In order to ensure a tight fit of the closure element 2 inserted into the bottom opening 1 3 of the breathing bag 1, the area 1 31 surrounding the bottom opening 1 3 of the bag bottom 1 30 is formed in a bead-like manner, so that gas-tight gluing, welding or similar joining processes can be used ,

According to a further embodiment of a closure element 2, which is shown in FIG. 3b, the closure part 20 can also be formed with an optionally closable hose connection 23, which communicates with the interior of the bag part 1 0 when the closure element 2 is inserted into the bottom opening 1 3 for example, the injection of medication and similar applications. Again, it is also possible to attach a retaining ring 22 at a suitable location on the closure element 2.

The closure part 2 is, for. B. made of a thermoplastic elastomer with a Shore hardness A of 65, which gives it good stability. As already mentioned at the beginning, the breathing bag shown in the drawings is advantageously produced by the injection molding process, which is shown in more detail in FIG.

For the production of the respiratory bag, a mold core 3 is used, which has a design corresponding to the inner contour of the respiratory bag with a bag area 31 serving for the molding of the bag part 10 and an integrally adjoining sleeve area 30 serving for the molding of the sleeve 12. At both of its ends lying in the direction of the longitudinal axis LA, the mandrel is fixed and supported on both sides by a mandrel bearing 4, 5 shown schematically in FIG. The mandrel bearing 5 is designed, for example, in the manner of a quill with a protruding engagement pin 50 and displaceable in the direction of the longitudinal axis LA, and the mandrel has a bore 33 extending in the direction of the longitudinal axis LA, so that it is possible to axially shift the To bring the mold core bearing 5 into engagement with the engagement pin 50 with the bore 33 of the mold core 3 and thus to form an operative connection between the mold core bearing 5 and the mold core 3. The engagement of the engagement pin 50 of the mold core bearing 5 is made possible via the bottom opening 1 3 to be formed in the breathing bag 1.

In an analogous manner, on the opposite side, which serves to form the sleeve 1 2, the mandrel bearing 4 also engages in the bore 33 of the mandrel 3 in its sleeve region 30 in the manner of a sleeve with a projecting engagement pin 40.

Due to this two-sided clamping of the mandrel 3 between the mandrel bearings 4, 5, the mandrel is held almost immovably in a predetermined position. The mold core 3 clamped in this way is subsequently enclosed by a two-part injection molding tool with an upper tool part 6a and lower tool part 6b, leaving a cavity H or cavity, which defines the shape and wall thickness of the respiratory bag to be produced. The rubber-elastic material, for example a thermoplastic elastomer in a thermoplastic state, is then injected into the cavity H under high pressure by means of a device (not shown in more detail here), whereby the respiratory bag 1 with bag part 1 0, an integrally molded sleeve 1 2 and a bottom opening 1 3 formed in the bag bottom 1 30 is produced. Due to the clamping and fixing of the mold core between the core bearings 4, 5 on both sides, high injection pressures can also be achieved without the mold core being displaced within the injection molding tool. This in particular enables the manufacture of the respiratory bag 1 from a thermoplastic elastomer with high precision, since thermoplastic elastomers require the high injection pressures explained above during injection molding.

After a short curing phase, the tool halves 6a, 6b can then be removed in a manner known per se, so that a breathing bag in the desired material thickness and shape remains around the mold core 3, which is shown in the illustration according to FIG Respiratory bag 1 is indicated.

Now you have to demold the manufactured in this way

Beamungsbeutels still the mold core 3 from the inside of the

Respiratory bag 1 are removed, which is commonly referred to as demolding.

For this purpose, the mandrel bearing 5 designed in the manner of a quill is replaced by a mandrel bearing in the direction of the longitudinal axis LA of the mandrel Displacement movement according to arrow K 1 brought out of engagement with the bore 33 of the mandrel 3. Now the respiratory bag can be slipped on or pushed over the bottom opening 1 3 formed and exposed in the bag bottom in accordance with arrows P1 in the direction of the sleeve 1 2 over the mandrel in the bag region 31, whereby only the bottom opening 1 3 of the respiratory bag 1 is stretched however, is justifiable due to the elastic material properties of the respiratory bag 1. As a result of this movement, the bag part 10 of the respiratory bag 1 folds into the position shown in solid lines in FIG. A good displaceability of the bottom opening 1 3 over the mandrel 3 is achieved in that the bottom opening 1 3 has an at least 5% larger diameter than the bag opening 100. Now the bag area 31 of the mandrel 3 is already exposed.

Subsequently, it is then possible to pull the mandrel 3 out of the sleeve 1 2 by pulling it in the opposite direction of the arrow P2 and pull it out from the mandrel 3, and in turn only the bottom opening 1 3 of the respiratory bag 1 experiences an acceptable elongation, which however, the sleeve 1 2, which is decisive for the gas tightness, experiences almost no expansion at all, which is reflected in the high production reliability of the respiratory bag 1.

After the mandrel 3 has been completely pulled out of the interior of the ventilation bag 1, a ventilation bag 1 designed according to FIG. 1 is obtained, which must now be closed by inserting a corresponding closure element 2 into the bottom opening 1 3 and is then ready for use.

Claims

claims:

1 . Inflatable ventilation bag made of a rubber-elastic material with a folded-in bag part with a bag bottom and a bag opening opposite the bag bottom for the air inlet and outlet and with a sleeve adjoining the bag opening with a continuous lumen for connecting a breathing gas line, characterized in that the sleeve (1 2) from the same material as that

Bag part (1 0) exists and is integrally formed on this and a bottom opening (1 3) is provided in the bag bottom (1 30) in the area opposite the bag opening (1 00), which can be closed by means of a closure element (2).

2. Respiratory bag according to claim 1, characterized in that a silicone elastomer or a thermoplastic elastomer (TPE) with a Shore hardness A of 20 to 70 is provided as the rubber-elastic material for the bag part (1 0) and the molded sleeve (1 2).

3. Respiratory bag according to one of claims 1 or 2, characterized in that the closure element (2) has a retaining ring (22).

4. Respiratory bag according to one of claims 1 to 3, characterized in that the closure element (2) has a hose connection (23) which in the bottom opening (1 3) inserted closure element (2) with the interior (I) of the bag part ( 1 0) communicates.

5. Respiratory bag according to one of claims 1 to 4, characterized in that the closure element (2) has a Shore hardness A of 50 to 80.

6. Respiratory bag according to one of claims 1 to 5, characterized in that the sleeve (12) in the transition region (123) to the bag part (10) has a radially protruding annular bead (122) on the outside.

7. Respiratory bag according to one of claims 1 to 6, characterized in that the bag part (10) has a wall thickness (d1) of 0.6 to 0.9 mm and the sleeve (12) has a wall thickness (d3) of 5 to 12 mm and the transition region (123) between the sleeve (12) and the bag part (10) has a wall thickness (d2) of 1.2 to 1.8 mm.

8. Respiratory bag according to one of claims 1 to 7, characterized in that the bottom opening (13) has at least the same diameter as the bag opening (100) in the transition region (123) to the sleeve (12).

9. Respiratory bag according to claim 8, characterized in that the bottom opening (13) has an at least 5% larger diameter than the bag opening (100) in the transition region (123) to the sleeve (12).

10. Respiratory bag according to one of claims 1 to 9, characterized in that the area (131) surrounding the bottom opening (13) of the bag bottom (130) is formed in a bead-like manner.

11. Respiratory bag according to one of claims 1 to 10, characterized in that the bag part (10) and the sleeve (12) are made in one piece by the injection molding process.

2. A method for producing a respiratory bag with a folded-in bag part according to one of claims 1 to 1 0 in the injection molding process with an injection molding tool with a mold core, characterized in that a mold core (3) is used, the longitudinal axis (LA) of which corresponds to the longitudinal axis of the bag and which its two ends is supported, whereby after the ventilation bag (1) is injection molded and the injection mold (6a, 6b) is removed, the bearing (5) of the mold core (3) in the region of the bag base (1 30) is removed and the bottom opening (1 3) is exposed and then the breathing bag (1) is pushed from the bag bottom (1 30) on the outside over the mold core (3) in direction (P1) to the bag opening (1 00) with sleeve (1 2) and the mold core thus exposed (3 ) is pulled out in the opposite direction (P2) from the sleeve (1 2) through the compressed ventilation bag (1) and then the bottom opening by means of a

Closure element (2) is closed.