DE1491793B1

DE1491793B1 - Process for the manufacture of an expandable balloon catheter from plastic and catheters manufactured according to this process

Info

Publication number: DE1491793B1
Application number: DE19641491793D
Authority: DE
Inventors: Andrew Harautuneian
Original assignee: American Hospital Supply Corp
Current assignee: American Hospital Supply Corp
Priority date: 1963-03-25
Filing date: 1964-01-10
Publication date: 1969-09-04
Also published as: GB1045202A; BE783616Q; FR1386808A

Description

1 21 2

Die Erfindung betrifft ein Verfahren zur Her- wenn diese Stelle beim Aufblähen des Ballons keinenThe invention relates to a method for when this point does not occur when the balloon is inflated

Stellung eines durch von außen zugeführtes Druck- äußeren Widerstand findet.Position of an external pressure supplied by an external resistance.

mittel aufweitbaren doppelwandigen Katheters aus Die Herstellung eines Ballons mit überall gleicher elastischem Kunststoff. Bei einem derartigen Katheter Wandstärke war daher nicht möglich.
ist es bekannt, in der Wand des Katheterrohres eine 5 Die Erfindung hat sich die Aufgabe gestellt, ein Druckmittelzuführung vorzusehen, über die der Verfahren zur Herstellung eines aufweitbaren Ballon-Katheter in einem Abschnitt seiner Länge aufgeweitet katheters aus elastischem Kunststoff mit einer in der und aufgebläht werden kann, nachdem er in den Wand des Katheters liegenden Druckmittelzuleitung Körper eines Patienten oder ein Organ einge- zum Ballon zu schaffen, welches sämtliche bei der führt ist. 10 bekannten Herstellung von Gummikathetern vorhan-medium expandable double-walled catheter from The manufacture of a balloon with the same elastic plastic everywhere. With such a catheter wall thickness was therefore not possible.
it is known to provide a pressure medium supply in the wall of the catheter tube, via which the method for producing an expandable balloon catheter is expanded in a section of its length and is made of elastic plastic with a catheter in the and inflated can be after he has inserted the pressure medium supply line in the wall of the catheter body of a patient or an organ to create the balloon, which is all with the leads. 10 known manufacture of rubber catheters

Bei der Herstellung von Kathetern dieser Art ist es denen Nachteile vermeidet und die Herstellung von bekannt, das gewöhnlich aus Gummi bestehende Kathetern einwandfreier Beschaffenheit aus Kunst-Hauptrohr an der Zone des seitlichen Austritts der stoff ermöglicht. Gemäß der Erfindung wird diese Druckmittelzuleitung mit einer chemisch wirkenden Aufgabe dadurch gelöst, daß das Katheterrohr im Schicht oder einem Überzug zu bedecken, der in 15 Bereich des zu bildenden aufblähbaren Ballons mit dieser Zone ein Anhaften des im Herstellungsver- einer durch Wasser oder einem anderen Lösungsfahren aufgebrachten ballonartig aufblähbaren Über- mittel lösbaren Schicht versehen und darauf auf dem zuges am Katheterende verhindert. Die chemisch Katheterrohr eine die Zwischenschicht überragende wirkende Schicht besteht aus einer Paste, die ihrer- elastische Schicht aufgebracht wird,
seits eine Mischung aus einer mit Talkpuder ver- ao Bei dem erfindungsgemäßen Verfahren kann die setzten Brom- oder Chlorlösung darstellt. Dieses die Ballonwand bildende elastische Schicht zweck-Verfahren bringt den Nachteil mit sich, daß im Falle mäßig durch Tauchen auf dem Katheterrohr und der einer Verletzung des aufblähbaren Ballons bei der Zwischenschicht aufgebracht werden. Dies kann vorBenutzung des Katheters kleine an der Oberfläche des teilhaft in der Weise durchgeführt werden, daß das Katheters anhaftende Talk- bzw. Brom- oder Chlor- 35 Katheterrohr nach Aufbringung der Zwischenschicht rückstände in den Körper des Patienten oder in das zwecks Bildung der elastischen Schicht in eine PoIykatheterisierte Organ gelangen können. Auf der esterurethanlösung getaucht wird,
anderen Seite bestand bei längerer Lagerung der- Bei dem erfindungsgemäßen Verfahren kann die artiger Katheter auch die Gefahr eines nachträglichen lösliche Schicht in Form eines Bandes auf das Ka-Zusammenklebens der Wandungsteile im Bereich des 30 theterrohr aufgebracht werden, und zwar vorteilhaft Ballons. Weiter hat dieses Verfahren den Nachteil, in der Weise, daß die Enden des auf das Katheterdaß es nur zur Herstellung von Kathetern geeignet ist, rohr aufgebrachten Bandes zur Überlappung gebracht die aus Gummi bestehen, da die aufgebrachte ehe- und anschließend die Überlappungsstelle geglättet mische Schicht nur bei gummiartigem Material ihren wird.In the manufacture of catheters of this type, it is known to avoid disadvantages and to manufacture the catheters, usually made of rubber, of perfect condition made of plastic main tube at the zone of the lateral exit of the material. According to the invention, this pressure medium supply line is achieved with a chemically acting task in that the catheter tube is covered in a layer or a coating that prevents the in the manufacturing process from sticking in the area of the inflatable balloon to be formed with water or another dissolution process applied, balloon-like inflatable transfer medium and releasable layer and then prevented on the move at the end of the catheter. The chemical catheter tube, an effective layer protruding beyond the intermediate layer, consists of a paste that is applied to its elastic layer,
on the other hand, a mixture of a powder mixed with talcum powder. This method of elastic layer forming the balloon wall has the disadvantage that, in the case of moderate dipping on the catheter tube and damage to the inflatable balloon, the intermediate layer is applied. Before using the catheter, this can be done in such a way that talc, bromine or chlorine adhering to the catheter remains in the patient's body after the intermediate layer has been applied or in the for the purpose of forming the elastic layer can get into a polycatheterized organ. Is dipped on the ester urethane solution,
On the other hand, there was a longer storage of the catheter in the method according to the invention, the risk of a subsequent soluble layer in the form of a tape on the glue-together of the wall parts in the area of the theter tube can be applied, advantageously balloons. This method also has the disadvantage that the ends of the tube applied to the catheter, which is only suitable for the manufacture of catheters, are made to overlap, which are made of rubber, since the applied layer is smoothed and then the overlap only with rubber-like material yours will.

Zweck erfüllen kann. Vorschläge, derartige Katheter 35 In allen Fällen kann das erfindungsgemäße Ver-Purpose. Proposals, such catheters 35 In all cases, the inventive method

auch aus Kunststoffen herzustellen, konnten bisher fahren in der Weise durchgeführt werden, daß in deralso produce from plastics, could be carried out so far in the way that in the

nicht verwirklicht werden. Wandung des Katheterrohres nach Herstellung dercannot be realized. Wall of the catheter tube after production of the

Besondere Schwierigkeiten bestanden bei dem be- Ballonwand abschließend die Katheteröffnung herkannten Herstellungsverfahren für Katheter aus gestellt wird.There were particular difficulties with the balloon wall finally recognizing the catheter opening Manufacturing process for catheters is made from.

Gummi auch hinsichtlich der Freihaltung der Aus- 40 Gegenstand der Erfindung ist fernerhin ein nachRubber also with regard to keeping the contents free. Furthermore, the subject matter of the invention is a

trittsöffnung der Druckmittelzuleitung in den Ballon. dem ihr zugrunde liegenden Verfahren hergestellteropening of the pressure medium supply line in the balloon. the process on which it is based

Die Herstellung der ballonartig aufblähbaren Hülle aufweitbarer Ballonkatheter aus elastischem Kunst-The manufacture of the balloon-like inflatable sleeve expandable balloon catheter made of elastic synthetic

am Katheterende erfolgte in zwei Arbeitsgängen. Der stoff, dessen wesentlichstes Merkmal darin besteht,at the end of the catheter was carried out in two steps. The substance, the main characteristic of which is that

erste Arbeitsgang bestand im Auftragen der chemisch daß im Bereich des Ballons eine in Wasser oderThe first step consisted of applying the chemical that in the area of the balloon in water or

wirkenden Schicht oder des Überzuges um die Zone 45 einem anderen Lösungsmittel lösliche vor der Be-acting layer or the coating around the zone 45 another solvent soluble before loading

des Austritts der Druckmittelzuführungsröhre aus nutzung ausspülbare Zwischenschicht zwischen derthe outlet of the pressure medium supply tube from use flushable intermediate layer between the

dem Katheterhauptrohr, wobei die Druckmittelzulei- Außenwand des Katheters und der Ballonwand an-the main catheter tube, the pressure medium supply outer wall of the catheter and the balloon wall

tung über den äußeren Mantel des Hauptkatheter- geordnet ist.device is ordered over the outer jacket of the main catheter.

rohres hinausragte. In einem ersten Tauchverfahren Ein erfindungsgemäß ausgebildeter Katheter hatpipe protruded. In a first immersion process, a catheter designed according to the invention has

wurde nun eine Schicht aus dem ballonartig aufbläh- 50 unter anderem den Vorteil, daß die Ballonwand auchnow a layer of the balloon-like inflates 50 among other things the advantage that the balloon wall also

baren Material auf das Katheterende aufgebracht. nach längerem Lagern nicht an der Katheterwandble material is applied to the end of the catheter. not on the catheter wall after long periods of storage

Anschließend wurde das Druckmittelzuleitungsrohr, ankleben kann und mit Sicherheit eine überall gleich-Then the pressure medium supply pipe was glued on and it is certain that the same everywhere

das noch seitlich aus dem Katheterhauptrohr heraus- mäßige Wandstärke besitzt.which still has a moderate wall thickness at the side of the main catheter tube.

ragte, in der Weise entfernt, daß die Öffnung des Im besonderen Vorteil kann die Ballonwand dabei Druckmittelzuführungsrohres plan mit dem äußeren 55 aus einer Kunststoffschicht von einer Dicke zwischen Mantel des Katheterhauptrohres abschloß. Im zweiten 0,07 bis 0,2 mm und einer Dehnung von etwa 300% Arbeitsgang wird diese plan abschließende Druck- bei 42 bis 84 kg/cm² Belastung bestehen,
mittelrohröffnung am Katheterende ihrerseits mit der Um den Aufblähungsgrad der aufweitbaren Kunstchemischen Schicht oder dem Überzug überdeckt, stoffschicht variabel zu gestalten, kann man eine und in einem zweiten Tauchverfahren wird die ballon- 60 Schicht vorsehen, die von 300 bis 600% Dehnung artig aufblähbare Kunststoffschicht auch über diese zerreißfest ist.protruded, removed in such a way that the opening of the In particular advantage, the balloon wall can thereby be flush with the outer 55 made of a plastic layer of a thickness between the jacket of the main catheter tube. In the second 0.07 to 0.2 mm and an elongation of about 300% work step, this level final pressure will ^{exist at 42 to 84 kg / cm 2} load,
In order to cover the degree of inflation of the expandable synthetic chemical layer or the coating, a layer of material can be designed in a variable manner, and in a second immersion process the balloon layer is provided, the plastic layer, which can also be inflated from 300 to 600% expansion over this is tear-proof.

Druckmittelrohröffnung gebracht. Die sich an der Weitere vorteilhafte Einzelheiten der Erfindung Druckmittelrohröffnung im Tauchverfahren bildende sind aus der Zeichnung ersichtlich, in welcher die ballonartige aufblähbare Folie mußte dabei häufig Erfindung beispielsweise in einer bevorzugten Ausdünner ausfallen als die Schicht, die in zweimaligem 65 führungsform veranschaulicht ist.
Tauchverfahren entstanden ist. Eine solche Stelle in Die besondere Art, in der das Katheterrohr, das der ballonartig aufblähbaren Folie kann sehr leicht Trennmittel und die außenliegende Schicht hergestellt zu einem Platzen des Ballons führen, zumal dann, und miteinander vereinigt werden, ergibt sich aus derBrought pressure medium pipe opening. The pressure medium pipe opening formed on the further advantageous details of the invention in the dipping process can be seen from the drawing, in which the balloon-like inflatable film often had to fail, for example, in a preferred thinner than the layer that is illustrated in twice guide form.
Immersion process has arisen. Such a point in the special way, in which the catheter tube, the balloon-like inflatable film can very easily release agent and the outer layer produced lead to a bursting of the balloon, especially since then, and are united with each other, results from the

Claims

3 43 4

following description of the invention wrapped with the help. It has been shown that the layer 16 with

of the pictures. It shows a thickness of about 0.07 to 0.2 mm due to

F i g. 1 Dip the front end of the two-hole pipe into a polyester urethane solution

equipped catheter tube in vertical section, can be produced. As a solvent for the

F i g. 2 one of the F i g. 1 corresponding representation, 5 polyester urethane, tetrahydrofuran, dimethyl

after applying the release agent layer, formamide or an 80:20 solution of tetrahydro-

F i g. 3 the same device can be used as with the vor- furan and cyclohexanone. To going images, but after the attachment of the immersion, the opening 12 in the wall inflatable outer layer and after production of the pipe provided with the outer layer herder Catheter opening, placed io, which serves to convey fluid from the outside to

F i g. 4 to penetrate the device according to the invention in the inward or from the inside to the outside

distended state and leave, depending on whether the catheter for irrigation or

5 shows a section through FIG. 3, which is used for cathetization.

Line 5-5. The catheter is in the Fig. 3 shown

The catheter tube 10 encloses a relative 15 condition. Water is used by moderately large inner line 11 and has a narrower line 13 and the opening 14 to the separating layer Line 13, passed through the liquid to the opening 14 15. The consequence of this is that the separation is brought about can be, which latter dissolves in the layer and the outer layer inside Pipe wall is located. The accesses to the length previously covered by the separating layer in lines 11 and 13 which are separate on the other can extend in the axial direction to form the balloon 17 according to FIG a conventional (not shown) arrangement F i g. 4 can expand or inflate. The scope are located. As mentioned earlier, the bloating can easily persist through appropriate the pipe 10 made of a suitable plastic material, dimensioning of the amount of water supplied is determined preferably made of polyvinyl chloride, which are used to achieve.

the desired softness and flexibility plastifi- as As explained above, can be used for the production of the

is adorned. Outer layer 16 a plastic material can be used

The first process that is used to produce the inflatable outer part, which is carried out at a load of 42 to 84 kg / cm ² , is an expansion of FIG. 2, as is preferably shown at around 70 kg / cm ^2, the application of a layer 15 which is 300%. The balloon can easily be about 0.5 to 1 mm thick. The layer 15 30 an elongation of at least 250% of the upper is applied in the area where the surface layer is later inflated, whereby the balloon-shaped inflation is to form, and the outer layer is again in a position after use due to its length in the axial direction which goes in, which causes the patient no discomfort when removing the catheter resulting from this direction during use. By measuring the inflated part. Within the tube section, which is enveloped by the pliability and pliability of the balloon, the layer 15 is furthermore an opening 14 that is gentle on the patient and a covering material, such as is guaranteed. If, which is hardly conceivable, the water-soluble polyvinyl alcohol film has a pressure medium supply channel clogged so that the adequate adhesion to the outside of the balloon tube 17 cannot be relieved, it may be necessary 10 and, on the other hand, easily dissolves in an aqueous 40 to destroy the balloon in order to be able to remove the catheter from solvent on, for example in on room temperature. In contrast to water from rubber temperature, the existing through the line devices, which is an undesirable 13 and the opening 14 is fed. The attachments have great elasticity and can accordingly be expanded to a very large extent the release agent in the form of a film, it is also the advantage of the invention that the thickness of the layer in front of the object is possible, a plastic for the outside and thus the smooth connection to choose the layer, the tear limit of which is about 300 to 600% elongation containing the opening 12 remaining uncovered. An example of one of the front and rear-extending like materials is a polyester urethane polymer, pipe section is guaranteed. The ends of the film, the tear limit of which is 540% elongation. Should it be possible to overlap one another somewhat, 50 it should be necessary to destroy the balloon, this can be so that the outer and balloon-shaped inflatable balloons can be brought about without any significant additional inflation of the bare layer in the area of the entire circumference of the tube,
is released. The overlapping ends of the

By using a heated patent, varnish can:
Tool smoothed and welded together 55

so that no gradation at the overlap 1. Method of making a widening point arises and at the same time a seal ble balloon catheter made of elastic plastic forms, through which in the manufacture of the outer lying with one lying in the wall of the catheter tube Layer 16 with the help of the immersion process no pressure medium supply line to the balloon, thereby Material can penetrate. 60 characterized in that the catheter tube (10) After the application of the layer 15 is the inflatable balloon to be formed in the area Outer layer 16 made of elastic plastic, preferred (17) with one by water or another wise polyester urethane, as shown in Fig. 3, solvent-releasable layer (15) and provided while wrapping the release agent and this afterwards on the catheter tube (10) one the two Sufficient length of the sides in lengthways 65 layer overlapping elastic layer (16) superior to the outer surface of the pipe is applied.

worn, wherein the outer layer also the pipe end 2. The method according to claim 1, characterized in

to achieve a secure attachment to the tube indicates that the balloon wall forming

elastic layer (16) by dipping onto the catheter tube (10) and the intermediate layer (15) is applied.

3. The method according to claim 2, characterized in that the catheter tube (10) according to Application of the intermediate layer (15) for the purpose of forming the elastic layer (16) in a polyester urethane solution is dived.

4. The method according to any one of claims 1 to 3, characterized in that the soluble Layer (15) is applied in the form of a tape to the catheter tube (10).

5. The method according to claim 4, characterized in that the ends of the on the catheter tube (10) applied tape to the overlap and then the overlap point is smoothed.

6. The method according to any one of claims 1 to 5, characterized in that in the wall of the catheter tube (10) and finally the catheter opening after the balloon wall has been produced (12) is produced.

7. According to one of claims 1 to 6 produced expandable balloon catheter made of elastic Plastic, characterized in that one in water or one in the area of the balloon other solvent-soluble intermediate layer (15) between the rinsable prior to use Outer wall of the catheter (10) and the balloon wall is arranged.

8. Catheter according to claim 7, characterized in that the balloon wall consists of a plastic layer (16) with a thickness between 0.07 and 0.2 mm and an elongation of about 300 ^e / o at 42 to 84 kg / cm ² load .

9. Catheter according to claim 7 or 8, characterized in that the intermediate layer (15) consists of a polyvinyl alcohol film.

1 sheet of drawings