DE10338338B4 - Tubing with a marker and method for making a mark on a tube - Google Patents

Abstract

Tube, comprising a wall (102) comprising a fluoropolymer, in particular Polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP), and a color marking and / or a radiopaque marker (108), characterized in that the color marking or the X-ray contrastable label (108) at least one annular separately from the wall (102) of the hose (100) made Marking element (112) comprises which is thermally welded to the wall (102).

Description

The The present invention relates to a hose having a wall, which is a fluoropolymer, in particular polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP), and a Color marking and / or a radiopaque marker includes.

Of the Term "polytetrafluoroethylene" includes in the context this specification and the appended claims, other than pure polytetrafluoroethylene (PTFE) also modified polytetrafluoroethylene, a polytetrafluoroethylene compound or a modified polytetrafluoroethylene compound.

Under a "modified Polytetrafluoroethylene "is while a PTFE-like Understand the substance, wherein the molecular structure of the PTFE thereby has been modified chemically that the fluorine atoms of the PTFE partially are replaced by substituents.

One such modified PTFE is, for example, under the name 62N known and obtained from the company DuPont.

Under a "polytetrafluoroethylene compound" is a mixture PTFE and at least one organic or inorganic filler to understand. As such fillers especially glass fibers, carbon fibers, carbon, graphite, molybdenum disulfide, Bronze, stainless steel, ceramics or organic fillers, in particular high temperature resistant thermoplastics and thermosetting plastics, into consideration.

Corresponding is a "modified polytetrafluoroethylene compound" a mixture to understand which is a modified polytetrafluoroethylene, for example 62N, and at least one organic or inorganic filler includes.

Hoses with a wall of polytetrafluoroethylene have a high chemical resistance, a good temperature resistance, Sterilisability and antiadhesive Properties on why such hoses in numerous applications in the chemical, electrical and mechanical industries as well be used in medical technology.

Especially it is known hoses made of polytetrafluoroethylene with colored ring markings in medical technology as catheter tubes, Papillotomas or as tubes for the Use endoscopy.

The Color markings serve to different hoses from each other to distinguish as well as an identified hose in one desired Able to position.

Around identify a hose and then in a desired Position to be able to position if the tube only in X-ray can be considered, as in medical technology, but can also be the case with other applications, it is known Such a tube with a radiopaque marker to provide.

Especially it is known to press metallic marking sleeves on a PTFE tube or to press into a PTFE tube. However, this brings the Disadvantage with that the outside diameter of the relevant tube at the marking point by the pressed-sleeve enlarged or that yourself the inner diameter of the hose through the metallic pressed into the hose Sleeve reduced.

A Magnification of the Outside diameter brings the disadvantage that the introduction the hose is made difficult in a passageway. In addition, can the hose with the end faces of the metal sleeve used on a Hang obstacle stay.

Becomes the metallic sleeve pressed into the hose, so will the implementation of probes, light guides and other objects through the interior obstructed the hose.

One Another disadvantage of the use of metal sleeves is that to the metal sleeves or in the gap between the metal sleeve and the hose surface dirt and can accumulate bacteria, which makes cleaning or even sterilization of the hose difficult or impossible power.

There the metal sleeves and the PTFE material of the hose greatly different thermal expansion coefficient may have the metal sleeves about that out at a temperature change Loosen or even loosen from the hose.

One Another disadvantage is that the flexibility of the PTFE tube in the area of the metal sleeve is reduced.

Finally is it also difficult the metal sleeve non-slip on or in the comparatively soft PTFE tube to fix. An accidental stripping of the metal sleeve can not be excluded.

From the DE 101 34 008 A1 It is known to provide a tube having a wall of a fluoropolymer with a coating containing a radiopaque material. This coating can be formed in particular by spraying a suspension containing the X-ray-resistant material.

The DE 89 05 642 U1 discloses a catheter tube of transparent polymeric material having radiopaque wall portions formed by applying a thin coating of X-ray resistant material.

The EP 0 512 412 A1 discloses a tube with annular colored markings which are produced by wrapping the tube blank in a film strip extending in the tube longitudinal direction whose width substantially corresponds to the tube circumference and which on its rear side facing the tube extends transversely to its longitudinal direction to the tube surface Having contrasting colored strips, wherein the tube blank is then vulcanized together with these strips and then the film strip is removed without the vulcanized color substance from the tube surface.

The DE 1 901 444 U discloses plastic pipes, which are provided by colored longitudinal strips, that a strip of similar, but colored, plastic in the longitudinal direction is placed on the jacket of the tube and this strip is thermally welded to the jacket of the tube.

Of the present invention is based on the object to alternative Way to create a hose of the type mentioned, which by the color marking and / or the radiopaque marker identifiable and / or positionable without the merits of a Loss of fluoropolymer material.

These The task is with a hose with the features of the preamble of claim 1 according to the invention thereby solved, that the Color marking or the radiopaque marking at least one ring comprises marking element made separately from the wall of the hose, the thermally welded to the wall.

Under "thermal Welding "is doing in this Description and in the appended claims each Process understood in which the material of the marking element at least partially softened and / or melted and become in this softened and / or molten state cohesively with the material of the wall of the hose connects.

Of the Term of the "wall" of the hose includes in this Description and in the attached claims the entire material surrounding the inner cavity of the tube, including all in any way before attaching the marking element the hose produced coatings.

Especially Thus, the tube to be marked can only with one or more Coatings and then be provided with the at least one marking element.

Thereby, that the hose according to the invention a marking element made separately from the wall of the hose comprises is it possible to have one Such hose with arbitrarily colored color marks and / or with radiopaque markers any X-ray absorption ability in a simple and quick way to make that a supply of marking elements of the desired Colors and / or X-ray absorption capabilities which is then very easily and quickly marked on the Hose positioned and thermally connected to the wall of the hose welded can be.

Of the hose according to the invention can color markings of any color in any color intensity and / or X-ray contrastable markers any desired X-ray contrast ability exhibit.

The in the form of a separately manufactured and with the wall of the hose thermally welded Marking element present color markers or radiopaque markers are abrasion resistant, sterilizable, flexible and biocompatible.

Especially these markings have none of the disadvantages mentioned above of wound on the tube to be marked or in the zu marking pressed hose metal sleeves on.

The Material from which the marking element is made may be the same Expansion coefficients as the material of the tube to be marked exhibit.

Further The material of the marking element can also have the same chemical resistance as the material of the tube to be marked have.

The flexibility of the tube to be marked is not by such a marker impaired.

at a preferred embodiment of the hose according to the invention is provided that the Marking element is fused with the wall of the hose. In this way, a particularly strong connection of the marking element achieved with the hose to be marked.

Basically that could Marking element on the inside or on the outside be arranged the wall of the hose to be marked.

Preferably However, it is envisaged that the Marking element with an outside welded to the wall is. In this case, the inside diameter of the to be marked Hose not reduced; the outer diameter is through the only welded to the wall of the hose marking element slight increased.

Preferably has that with the outside of the Wall welded Marking element not transverse to the longitudinal direction of the hose from the wall of the same projecting end faces, but instead End areas extending at a small acute angle from the Lift the wall of the hose and gradually to the area of greatest thickness of the marking element increase.

Of the Area of greatest thickness of the marking element preferably has a thickness of less as about 0.4 mm, in particular less than about 0.2 mm.

at The invention provides that the marking element is annular is and thus surrounds the wall of the tube to be marked annularly.

Around the chemical and physical properties of the marking element as far as possible to adapt to those of the wall of the hose is preferred provided that the Labeling a fluoropolymer, especially polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP).

Around the marking element X-ray contrast capability to confer, it can be provided that the marking element a X-ray contrastable material contains.

Under a radiopaque material to understand a material which has a significantly higher absorption capacity for X-radiation has as the material of the wall of the tube, so that marked Place the tube in the radiograph clearly distinguishable from non-labeled sites.

When X-ray contrastable material in particular Bismuth carbonate, barium sulfate, titanium dioxide and / or a metal powder be used.

Around a particularly high X-ray contrast capability the marking and thus a particularly good visibility of the mark in the x-ray To achieve it is advantageous if the marking element at least approximately 20 weight percent, preferably at least about 50 weight percent, in particular at least approximately 70% by weight, X-ray contrastable material contains.

Around to achieve that Can be seen in the visible light, may be provided that this Labeling element contains at least one pigment.

Especially it is also possible that the marking element both at least one X-ray contrastable material as well as at least one pigment, in particular a color pigment. Further can be provided that the Marking element contains a material which is both X-ray contrastable and the properties of a pigment.

Around not only identify the tube by means of the marking, but also in a desired Position along its longitudinal axis and / or in a desired Angular position with respect its longitudinal axis to be able to position is it cheap if the marking element is less than the entire outer surface of the Hose covered.

Further is in preferred embodiments the invention provided that the Hose includes a plurality of marking elements.

Especially can be provided that at least two of the markers are in terms of their absorbency for X-radiation differ from each other. This leads to this Markings in the radiograph appear in different gray values and thus distinguishable from each other are.

alternative or in addition For this purpose, it can be provided that at least two of the marking elements differ in color differ. this leads to for that Markers in visible light appear in different colors and thereby distinguishable from each other.

at a preferred embodiment of the hose according to the invention is provided that at least two of the marking elements are spaced from each other, wherein the marking elements in the longitudinal direction the hose and / or in the circumferential direction of the hose from each other can be spaced.

Of the The present invention is based on the further object of an alternative Method for producing a marking on a hose of the above mentioned type, which is a perfect identification and / or positioning of the hose and allows the benefits a tube of a fluoropolymer receives.

• – Herstellen eines Markierungselements getrennt von dem Schlauch, wobei der Schritt des Herstellens des Markierungselements folgendes umfaßt: Herstellen eines Schlauches oder einer Hülse aus einem Markierungsmaterial und Abtrennen eines ringförmigen Markierungselements von dem Schlauch bzw. von der Hülse;
• – Positionieren des Markierungselements in einer gewünschten Lage relativ zu dem Schlauch;
• – thermisches Verschweißen des Markierungselements mit der Wandung des Schlauchs.

This object is achieved in a method having the features of the preamble of claim 14 by the following method steps:

• Forming a marker separate from the tube, wherein the step of producing the marker comprises: forming a tube or sleeve from a marker material and severing an annular marker from the tube;
• - positioning the marking element in a desired position relative to the tube;
• - Thermal welding of the marking element with the wall of the hose.

Around the inner diameter of the annular marking element before positioning relative to the tube to be marked can enlarge be provided that the Hose or the sleeve from the marking material before separating the annular marking element be widened.

alternative or in addition For this purpose, it can be provided that the annular Marking element before positioning relative to the mark to be marked Hose is widened, for example by the annular marking element via a frusto-conical mandrel is pulled.

at a preferred embodiment of the method according to the invention is provided that the Marking element is fused with the wall of the hose.

Further Features and advantages of the invention are the subject of the description and the drawings of embodiments.

In show the drawings:

1 a side view of a portion of a hose with a wall of PTFE, PFA or FEP and several markings;

2 a schematic longitudinal section through a filled with X-ray contrast material and / or color pigment hose from which a marking ring is tapped;

3 a schematic longitudinal section through a hose to be marked and a pushed onto the tube to be marked marking ring;

4 a schematic longitudinal section through the hose and the marking ring 3 after the marking ring has been fused to the wall of the tube to be marked; and

5 a schematic section through the tube to be marked and the marking ring 4 , along the line 5-5 in 4 ,

Same or functionally equivalent Elements are designated in all figures with the same reference numerals.

One in the 1 . 4 and 5 shown as a whole with 100 designated hose comprises a flexible, hollow cylindrical wall 102 which has a cylindrical interior 104 the hose encloses and along a longitudinal direction 106 of the hose extends.

The wall 102 of the hose 100 is formed, for example by a paste extrusion process, from polytetrafluoroethylene (PTFE), from modified polytetrafluoroethylene, from a polytetrafluoroethylene compound or from a modified polytetrafluoroethylene compound or, for example by a thermoplastic extrusion process, from PFA or FEP.

The hose 100 is with several markings 108 provided, which the wall 102 of the hose 100 surrounded annularly and along the longitudinal direction 106 spaced apart from each other.

The marks 108 differ in terms of their color, for example, is a first, the wall 102 ring-shaped marking 108a colored black.

On the first black mark 108a following further annular markings 108b . 108c . 108d , which along the longitudinal direction 106 of the hose 100 are spaced apart, for example, green, yellow or red colored.

On the red mark 108d follows for example example, another black-colored marker 108e , which is designed as a double mark and comprises two annular, black-colored part markings.

The different colors allow a distinction of the markings 108 when an observation with visible light, for example by means of a video camera, is possible.

To the markings 108 The marks are also distinguishable in an observation with X-ray light 108 provided with different absorbance for X-radiation in a manner to be described in more detail below.

Each of the marks 108 is made by making a marking ring of the desired color and absorptivity for X-radiation, drawing the marking ring onto the tube to be marked 100 and then welding the marking ring to the wall 102 of the hose 100 produced.

This manufacturing method will be described below with reference to FIGS 2 to 5 explains:

First, in an extrusion process known per se, for example a paste extrusion process or a thermoplastic extrusion process, which is described in US Pat 2 schematically illustrated in longitudinal section marking material tube 110 produced.

The material from which the marking material tube 110 produced by extrusion, the same base material as the tube to be marked 100 include. If the hose to be marked 100 So includes PTFE, so can the Markierungsmaterialschlauch 110 PTFE include.

For the welding of the marking ring with the tube to be marked, it may also be advantageous if the marking ring comprises a base material which has a lower melting temperature than the material of the tube to be marked. For example, the marking material tube 110 as basic material include FEP and the tube to be marked 100 as base material comprise PTFE whose melting temperature is higher than that of FEP.

To the desired color of the later mark 108 to obtain the material from which the marking material tube becomes 110 extruded, a pigment of the desired color is added.

Preferably, the weight proportion of the color pigment added is about 0.1% to about 20% by weight of the total material of the marking material tube 110 ,

To the desired X-ray absorption capacity of the label 108 to obtain the material from which the marking material tube becomes 110 An X-ray contrastable material, for example barium sulfate, bismuth carbonate, titanium dioxide and / or a metal powder, is added.

The proportion of the X-ray-resistant material on the material of the marking material tube is preferably 110 from about 50 weight percent to about 95 weight percent, preferably from about 70 weight percent to about 90 weight percent.

ever according to the desired Color and the desired X-ray absorption ability can also use one and the same material both as pigment and as well as a radiopaque material be used.

The total proportion of the material of the marking material tube 110 added pigments and X-ray contrastable fillers on the material of the marking material tube 110 is preferably about 3% to about 95% by weight, more preferably about 5% to about 90% by weight.

The marking material tube 110 is widened so that its expanded inner diameter d 'is slightly larger than the outer diameter D of the tube to be marked 100 ,

This widening can be effected, for example, by the marking material tube 110 is pulled over a mandrel whose largest diameter corresponds to the desired inner diameter d '.

Subsequently, by means of a suitable tool, a marking element 112 in the form of a marking ring 114 with the desired width B (extension in the longitudinal direction of the marking material tube 110 ), in particular tapped (see 2 ).

The severed marking ring 114 is on the hose to be marked 100 raised and at the point where the mark 108 is to be generated, positioned (see 3 ).

Subsequently, the marking element 112 by means of a suitable heating device heated to a temperature such that the fluoropolymer base material of the marking element 112 Thus, for example, the PTFE, the PFA and / or the FEP melts, and with the material on the outside of the tube to be marked 100 combines.

Contains the marking element 112 as the fluoropolymer base material PTFE, the marking element becomes 112 preferably heated to a temperature of more than 320 ° C, for example of about 340 ° C, heated.

Contains the marking element 112 as the fluoropolymer base material FEP, then the marking element 112 preferably heated to a temperature of at least about 290 ° C.

Furthermore, it is favorable, although the material on the outside of the wall 102 of the hose to be marked 100 is heated so that it softens and so very well with the material of the marking element 112 combines.

By (at least partially) melting of the marking element 112 and softening and / or melting the outside of the wall 102 of the hose 100 become the marking element 112 and the hose 100 thermally welded together, with the end faces of the marking element 112 deform so that the outer surfaces of the marking element 112 from the wall 102 of the marked hose 100 from under a small acute angle gradually up to the area 116 largest thickness of the marking element 112 increase.

In this area 116 largest thickness is the thickness of the hose 100 welded marking element 112 preferably less than 0.4 mm, in particular less than 0.2 mm.

The heating device for heating the marking element 112 and possibly also the outside of the wall 102 of the hose to be marked 100 For example, it can comprise an IR radiation source, a halogen radiator, a hot air blower and / or an electrical resistance heater, for example a heating tape.

The heating of the marking element 112 and possibly the outside of the wall 102 of the hose to be marked 100 can in particular by irradiation with IR radiation, by irradiation with the spectrum of a halogen lamp, by exposure to heated air or with another heated gas or by supplying heat by means of an electrical resistance heating (by heat radiation and / or by convection on the marking element 112 and the wall 102 of the hose 100 is transmitted).

If that as a marker ring 114 trained marking element 112 has been widened before heating, so the marking ring pulls 114 when melting together and generates a contact pressure on the tube to be marked 100 , This supports the merging of the marking element 112 with the hose to be marked 100 Additionally.

In this way will be at the desired location of the hose 100 a mark 108 produced, which forms an inseparable unit with the hose surface.

To several markings 108 on the hose 100 which are different in terms of their color in the optical range and / or in terms of their absorption capacity for X-radiation, become marking elements 112 in the form of marking rings 114 in the desired width of marking material tubing 110 separated from a material having the desired color and / or the desired X-ray absorptivity on the tube 100 positioned in the desired position and thermally with the wall 102 of the hose 100 welded.

The thermal welding can be used for the individual markings 108 consecutively or simultaneously for all markings 108 respectively.

In this way, the in 1 shown marks 108 on the hose 100 generated.

The markings produced in this way 108 are abrasion resistant, sterilizable and biocompatible. They have the same coefficient of expansion and the same chemical resistance as the basic hose 100 , The inner diameter of the hose 100 is through the markings 108 not reduced and the outer diameter of the hose 100 is only slightly enlarged.

Further, the flexibility of the hose 100 through the markings 108 not impaired.

Claims (17)

Hose comprising a wall ( 102 ), which comprises a fluoropolymer, in particular polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP), and a color marking and / or a radiopaque marker (US Pat. 108 ), characterized in that the color marking or the Röntgenkontrastfä mark ( 108 ) at least one annular separated from the wall ( 102 ) of the hose ( 100 ) produced marking element ( 112 ), which is connected to the wall ( 102 ) is thermally welded. Hose according to claim 1, characterized in that the marking element ( 112 ) with the wall ( 102 ) of the hose ( 100 ) is merged. Hose according to one of claims 1 or 2, characterized in that the marking element ( 112 ) with an outside of the wall ( 102 ) is welded. Hose according to one of claims 1 to 3, characterized in that the marking element ( 112 ) contains a fluoropolymer, in particular polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP). Hose according to one of claims 1 to 4, characterized in that the marking element ( 112 ) contains a radiopaque material. Hose according to claim 5, characterized in that that this X-ray contrast material bismuth carbonate, Barium sulfate, titanium dioxide and / or a metal powder. Hose according to one of claims 5 or 6, characterized in that the marking element ( 112 ) contains at least about 20 weight percent, preferably at least about 50 weight percent, more preferably at least about 70 weight percent, of X-ray contrastable material. Hose according to one of claims 1 to 7, characterized in that the marking element ( 112 ) contains at least one pigment. Hose according to one of claims 1 to 8, characterized in that the marking element ( 112 ) less than the entire outer surface of the hose ( 100 ) covered. Hose according to one of claims 1 to 9, characterized in that the hose ( 100 ) several marking elements ( 112 ). Hose according to claim 10, characterized in that at least two of the marking elements ( 112 ) differ in their X-ray absorptivity. Hose according to one of claims 10 or 11, characterized in that at least two of the marking elements ( 112 ) differ in color. Hose according to one of claims 10 to 12, characterized in that at least two of the marking elements ( 112 ) are spaced from each other. Method for producing a marking ( 108 ) on a hose ( 100 ) whose wall comprises a fluoropolymer, in particular polytetrafluoroethylene (PTFE), a perfluoroalkoxy polymer (PFA) and / or a fluorinated ethylene-propylene (FEP), characterized by the following process steps: - producing a marking element ( 112 ) separated from the hose ( 100 ), wherein the step of producing the marking element ( 112 ) comprising: making a hose ( 110 ) or a sleeve of a marking material and separating an annular marking element ( 112 ) of the hose or of the sleeve; - positioning the marking element ( 112 ) in a desired position relative to the tube ( 100 ); Thermal welding of the marking element ( 112 ) with the wall ( 102 ) of the hose ( 100 ). Method according to claim 14, characterized in that the hose ( 110 ) or the sleeve before the separation of the ringfömigen marking element ( 112 ) be widened. Method according to one of claims 14 or 15, characterized in that the annular marking element ( 112 ) before positioning relative to the tube ( 100 ) is widened. Method according to one of claims 14 to 16, characterized in that the marking element ( 112 ) with the wall ( 102 ) of the hose ( 100 ) is merged.