WO2015049132A1

WO2015049132A1 - Balloon catheter

Info

Publication number: WO2015049132A1
Application number: PCT/EP2014/070306
Authority: WO
Inventors: Wolfgang Haag
Original assignee: M T W - Endoskopie W. Haag Kg
Priority date: 2013-10-02
Filing date: 2014-09-24
Publication date: 2015-04-09
Also published as: DE102013110989A1; AU2014331332A1; KR20160065191A; CN105517619A; JP2016538007A; EP3052178A1

Abstract

The invention relates to a balloon catheter, comprising a catheter line (2), a balloon, and a connection device, wherein at least a first channel (11) extends in the catheter line (2). The first channel is connected to the first connection in a first channel length segment (31) and is connected to the balloon interior at least in a second channel length segment (32). A valve tube (13) is arranged in the first channel (11) between the first channel length segment (31) and the second channel length segment (32), a sealing element (14) is movably arranged in the first channel (11), and a spring element (15) is arranged in the first channel (11) next to the sealing element (14) on the side of the sealing element opposite the valve tube (13), wherein the longitudinal end of the spring element (15) closer to the sealing element (14) presses the sealing element (14) in the direction of the valve tube (13) by means of spring force.

Description

balloon catheter

The present invention relates to a balloon catheter, comprising a catheter line, an expandable balloon, which borders a balloon interior and which is formed on the catheter line, and a connection device which has at least one first connection for supplying fluid, for example the catheter line is arranged, extending in the catheter line extending in its longitudinal direction, at least one first channel which is at least in a first channel length portion in fluidic connection with the first port and at least in a second channel length portion in fluid communication with the balloon interior ,

Such a balloon catheter is known in the art from US 2011/0118546 AI. It describes that balloon catheters are used in bile duct endoscopy, passing through the working channel of an endoscope. The cited US disclosure deals with the problem that the connections for the pressurized fluid and, if necessary, for contrast agent and a guide wire having proximal connection device of the balloon catheter can not be guided through the working channel according to their dimensions. However, in order to facilitate a desired exchange of endoscopes, with the balloon catheter with expanded and quasi-anchoring in the bile duct remaining balloon as a guide, US 2011/0118546 AI proposes that the connection means by means of a suitable coupling and valves of the remaining balloon catheter arbitrarily often on and uncoupled. The designs proposed in US 2011/0118546 AI are comparatively complicated and expensive. Against this background, the invention has the object, advantageously develop a balloon catheter of the type mentioned. In particular, the aim is to achieve the most cost-effective and advantageous use of training, which should in particular also reduce the risk of operating errors. In particular, the balloon catheter with expanded balloon to facilitate the simplest possible removal of the connection device while maintaining the balloon expansion and a subsequent subsequent targeted cancellation of balloon expansion. The object is achieved according to a first aspect of the present invention initially and essentially in conjunction with the features that in the first channel between the first channel length portion and the second channel length portion, a valve tube is arranged and secured against displacement at least in the direction of the connection means that in the first channel a sealing element adjacent to the second channel length portion closer longitudinal end of the valve tube and slidably disposed in the longitudinal direction of the first channel, that in the first channel adjacent to the sealing element on its side opposite to the valve tube side, a spring element, in particular a cylinder compression spring arranged is, wherein the distal of the sealing element longitudinal end of the spring element is secured against displacement at least in the direction of the balloon and wherein the closer the sealing element longitudinal end of the spring element, the sealing element by means of spring force i n direction to the valve tube pushes. In place of the elaborate, known from the cited prior art valves that can be manually activated and deactivated to be there desired multiple coupling and uncoupling of the connection device by a user with control means, enters a comparatively simple spring-check valve. This allows a cheap construction of the balloon catheter. It can be derte coupling elements are omitted for multiple coupling and uncoupling of the connection device. Instead, as explained below, the possibility that the connector device, for example, to exchange an endoscope, while the balloon is expanded in a body cavity, the possibility to separate the connector on the proximal side of the valve from the balloon catheter, for example . to cut off. In order later to allow the balloon expanding fluid later specifically escape from the balloon, it is possible to then sever the catheter line on the distal side of the valve, for example, to cut, ie separate the valve line from the catheter. As usual, the term proximally refers to a user-facing side or a user-closer longitudinal end of a contemplated component of the balloon catheter, while the term distal refers to the user's more distant side. called components. Correspondingly, a direction pointing towards the user in the proximal direction and a direction pointing away from the user in the distal direction are understood.

Preferably, it is provided that the balloon catheter has a protective sheath which surrounds the catheter line in a longitudinal section which extends from the connecting device in the direction of the balloon beyond the valve, and in that the protective sheath comprises an externally perceptible marking, in particular a visible one Ring in a first color, which is located in the longitudinal direction of the catheter line positionally between the Anschlussein- direction and the valve. As will be explained below, this allows a use-advantageous development in which the risk of incorrect operation is reduced. The protective cover can additionally serve as kink protection. As a protective cover can, for example, in comparison to the wall thickness of Catheter tube thicker shrinkage tube can be used, which is not shrunk onto the catheter line, but surrounds them loosely in cross-section. The mark on the protective cover can be formed, for example, by a shrunk on the outside shrink ring of shrink tubing in a different color of the protective cover. The ring may be shrunk in such a way that the protective sheath there loosely surrounds the catheter line in cross-section.

The aforementioned idea that the balloon catheter comprises a protective sheath with a marking surrounding the catheter line in sections beyond the valve can also be significant in the context of the invention independently of the characterizing features of claim 1. Accordingly, the invention proposes, starting from the aforementioned prior art, to achieve the object mentioned in accordance with a second aspect of the invention, that in the first channel between the first channel length portion and the second channel length portion, a valve member is arranged, which with the surrounding Wall of the first channel forms a valve, or that in the first channel between the first channel length portion and the second channel length portion a plurality of valve members are arranged, which form a valve with the surrounding wall of the first channel, or that in the first channel between the first channel length portion and the second channel length portion, a valve is arranged, that the flow resistance of the valve for fluid upon application of a pressure gradient, wherein the fluid pressure in the first channel length portion of the first channel between the valve and the connecting device by a certain differential pressure amount gr SSER than in the second length of duct section of the first channel between the valve and the balloon interior, in the direction of this pressure drop is less than with application of an opposite thereto Druckgefäl- in which the fluid pressure in the first channel length portion is less than that in the second channel length portion in the direction of this opposite pressure gradient that the balloon catheter has a protective sheath which secures the catheter conduit in a length portion extending from the connector towards the opposite channel Balloon extends beyond the valve, surrounds and that the protective cover has an externally noticeable mark, in particular a visible ring in a first color, which is located between the connecting device and the valve. With regard to the second aspect of the invention, it is preferred that at least the following valve parts are arranged in the first channel between the first channel length section and the second channel length section:

a valve tube which is secured against displacement at least in the direction of the connection device,

a sealing element, which is displaceable adjacent to the longitudinal end of the valve tube which is closer to the second channel length section and in the longitudinal direction of the first channel,

a spring element, in particular a cylinder compression spring, adjacent to the sealing element on its side opposite the valve tube,

wherein the further from the sealing element longitudinal end of the spring element is secured against displacement at least in the direction of the balloon, and wherein the sealing element closer longitudinal end of the spring element presses the sealing element by means of spring force in the direction of the valve tube.

With regard to the aforementioned aspects of the invention, there are numerous further possibilities for the preferred development. For example, it is preferred that the catheter conduit within a length portion extending from the valve to the distal longitudinal end of the protective sheath, one mark, in particular a visible ring in a second, of the first color different color, has. In this context, it is further preferred that the marking of the catheter line from the outside through the protective cover is not visible by the mark on the catheter line is visible only after the balloon catheter has already been cut at the marking of the protective cover. This further reduces the risk of incorrect operation of the balloon catheter. An expedient embodiment is also seen in the fact that the protective cover is fastened at its proximal longitudinal end to the connection device, in particular releasably secured, in particular attached to the connection device, and that the protective cover the Kathe- terleitung at least in a longitudinal part section in which the valve and the marking of the catheter line are arranged loosely surrounding with respect to the cross-sectional dimensions. Also regarding the previously mentioned valve manifold designs are conceivable. Preference is given to the fact that the sealing element completely fills the channel cross-section of the first channel or fills, leaving only one of a clearance fit for displacement of the sealing element in the channel longitudinal direction forming edge gap. This reduces the risk of jamming and jamming. With regard to the spring element is preferred that this has either a linear or a progressive spring characteristic. Alternatively or in combination, it is envisaged that mutually adjacent turns of the cylinder compression spring abut each other in a spring member length section facing the sealing element and run at a distance from one another at least in a middle spring part length section. A compressed juxtaposition of adjacent spring coils makes it easier during manufacture to produce a spring end face perpendicular to the spring longitudinal center line, for example by surface grinding. It would also be conceivable that mutually adjacent turns of the cylinder compression spring in the region of both spring longitudinal ends are adjacent to each other. In an expedient embodiment it is provided that in the first channel on the side opposite the sealing element of the spring element, a retaining tube is arranged, which is secured against displacement at least in the direction of the balloon and wherein the retaining tube zuweisende longitudinal end of the spring element against the retaining tube supported. In addition, it is preferred that the valve tube and / or the holding tube are or are held in the longitudinal direction by means of press fit in the first channel and / or that the valve tube and / or the holding tube has or have on its outer jacket one or more anchoring projections, in particular it is provided that the anchoring projections taper conically.

To simplify the production, it is preferred that the catheter line comprises three line sections, wherein a first line section fixedly attached to the arrival-closing device, in particular glued to the terminal device, pressed, fused or the like, and wherein the balloon is formed on the second line section and wherein the third conduit section in which the valve is located interconnects the first and second conduit sections. A fixed attachment is understood to be one which, when used as intended, can not be released, at least not without the risk of damage or destruction, being releasable. In particular, it is a fixture that is not suitable for the intended multiple coupling and uncoupling. The catheter tube is preferably made of elastically deformable material. Said first connection of the connection device may comprise a valve which can be switched to an open and a closed position. The connection device may expediently have a second connection for the supply of fluid and a third port for passing a guide wire. The catheter line may expediently have in its interior a second channel extending in its longitudinal direction, which is in open fluid communication with the second connection and with the third connection of the connection device and which opens up to a, preferably frontal, opening of the catheter line extending distal end. The second channel may preferably have a larger cross section than the first channel. To connect the three above-mentioned line sections is preferred that a first connecting tube is provided, which is firmly inserted into a respective length in the first channel at each longitudinal end of the first and third line section, that a second connecting tube is provided which in each one longitudinal section in the first channel is firmly inserted into each of a longitudinal end of the second and the third line section, that a first connecting tube is provided, which is firmly inserted in a respective longitudinal section in the second channel at a respective longitudinal end of the first and the third line section , And that a second connecting tube is provided, which is firmly inserted in each case a longitudinal section in the second channel at a respective longitudinal end of the second and the third line section. In particular, in this context, there is also the possibility that at the junctions between the first and the third line section and at the junction between the second and the third line section a seal, in particular by means of sealing compound or adhesive or cohesive connection is formed. It is considered appropriate that the outer diameter of the hollow needle is a few tenths or hundredths of a millimeter larger than the inner diameter of the first channel, so that the hollow needle after a divergence of Käthe- terleitung, in particular after a separation of the valve from a further connected to the balloon longitudinal portion of the catheter tube at the proximal longitudinal end formed in the separation in the first channel to achieve a plug-clamp connection is inserted. There is the possibility that the filling device comprises a stylet which can optionally pass through the connection, through the fluid passage in the housing and through the hollow needle or can be removed from the filling device. Finally, there is also the possibility that the catheter line between the valve and the balloon is severed, in particular cut, and that the hollow needle is inserted at the proximal longitudinal end of the still connected to the balloon length of the catheter line in the first channel to achieve a plug-in connection ,

A balloon catheter according to the invention and a preferred application will be further described below with reference to the accompanying figures, which indicate preferred embodiments. It shows:

1 shows a balloon catheter according to the invention according to a first preferred embodiment in a shortened by two risers side view, before the start of the fluid supply;

Fig.la detail Ia of Figure 1 in a sectioned magnification.

FIG. 1b shows detail Ib from FIG. 1 in a sectioned enlargement;

FIG. 2 shows the balloon catheter from FIG. 1, but after the supply of fluid with the balloon inflated; FIG. Fig. 2a detail IIa of Figure 2 in a sectioned magnification.

Fig. 2b detail IIb of Figure 2 in an enlarged sectional view. Fig. 3a detail purple of Figure 1 in an enlarged view.

FIG. 3b shows the detail shown in FIG. 3a, but without protective cover; FIG.

Fig. 4 detail IV of Figure 3b in an enlarged sectional view.

FIG. 4a shows the individual parts of the arrangement shown in FIG. 4; FIG.

5 shows the arrangement shown in Figure 4 in the idle state. Figure 6 shows the arrangement shown in Figure 4 during the filling of the balloon.

FIG. 7 shows the arrangement shown in FIG. 4, after the filling of the balloon and after the end of the fluid supply; 8 is a sectional view through the catheter line along section line VIII

- VIII in Figure 7, in contrast, in magnification.

Fig. 9, the balloon catheter according to Figures 1 to 8 in conjunction with a

Guidewire and with a first endoscope in a first exemplary state of use;

10 shows the balloon catheter according to FIGS. 1 to 8 and the first endoscope, in a later exemplary state of use; FIG. 11 shows the balloon catheter according to FIGS. 1 to 8 and a second endoscope, in a later exemplary state of use; FIG. 12 shows the balloon catheter according to FIGS. 1 to 8 and the second endoscope according to a later exemplary state of use;

13 is a side view of a filling device with mandrin inserted therein, according to a preferred embodiment, for use with a balloon catheter according to the invention;

FIG. 14 shows a longitudinal section of the filling device with inserted stylet shown in FIG. 13; FIG. Fig. 15 in a longitudinal section, the filling device according to the figures

13, 14, with the stylet removed and a syringe connected to the fluid supply;

16, starting from FIG. 12, the proximal longitudinal end of the catheter line still connected to the balloon after the valve is separated when the filling device is connected, and FIG

Fig. 17, the arrangement shown in Fig. 12, but after the refilling of the balloon with fluid.

With reference to FIGS. 1 to 8, a balloon catheter 1 according to the invention is presented according to a preferred embodiment. This comprises a catheter line 2, an expandable balloon 3, which has a balloon interior 4. randet and which is formed on the catheter line 2 in the vicinity of its distal longitudinal end 5. Furthermore, the balloon catheter 1 comprises a connection device 6 which has a first connection 7, a second connection 8 and a third connection 9. The first port 7 serves to supply a pressurized fluid, for example of air, to inflate the balloon 3. For this purpose, in the example, a syringe 18 is connected to the terminal 7 by means of a screw or plug connection. Between syringe 18 and port 7, a shut-off valve may be provided. The second port 8 serves to supply another fluid, for example of contrast agent, and the third port 9 serves to carry out a guide wire or mandril illustrated in later figures. The connection device 6 is connected to the catheter line 2 in the region of its proximal longitudinal end 10. As already shown in FIG. 1 a, two hollow channels parallel to one another extend within the catheter line 2 in the longitudinal direction thereof, the first channel being designated by the reference numeral 11 and the second channel by the reference numeral 12. The first channel 11 is in fluid communication with the first port 7 at its proximal longitudinal end. The second channel 12 is in fluid communication with the second port 8 and is also in open communication with the third port 9, so that the ports 8 and 9 together open into the second channel 12. The first channel 11 is at its distal longitudinal end with the balloon interior 4 in a fluid, ie passable by fluid, compound. The first channel 11 extends from the first port 7 to the balloon interior 4. By means of a laterally from the channel 11 into the balloon interior 4 leading through bore 42 of the channel 11 is in its channel length section between a valve 28 and the distal longitudinal end of the channel eleventh , which shows figure 1b, with the balloon interior 4 in continuous continuous fluidic connection. The passage opening 42 is thus located within the balloon interior. According to FIG. 1b, in the example, the distal longitudinal end of the channel 11 is located a short distance behind (ie on the distal side) of the through-bore 42 and is closed like a blind hole. Figure la and subsequent figures show that for forming the valve 28 in the first channel 11, a valve tube 13 is arranged and secured against displacement at least in the direction of the connecting device 6, ie in the proximal direction, that in the first channel 11, a disc-shaped sealing element 14 adjacent to the distal longitudinal end of the valve tube 13 and in the longitudinal direction L of the catheter line 2 and the first channel 11 is slidably disposed and that in the first channel 11 adjacent to the sealing element 14 at its opposite to the valve tube 13, that is distal, side a spring element 15, which in the example is a cylinder compression spring 15 ', is arranged. The distal end of the spring element 15, which is formed on the last spring turn in the distal direction of the sealing element 14, is secured against displacement in the direction of the balloon 3, ie against displacement in the distal direction. The closer to the sealing element 14, ie the proximal longitudinal end of the spring element 15, which is formed by the last spring winding viewed in the proximal direction, presses the sealing element 14 by spring force in the direction of the

Valve Tube 13. In the example, the sealing element 14 is a silicone sealing disc. This may, for example, have a hardness of 40 ° Shore. The first channel 11 has a substantially circular channel cross-section. With regard to the shape and size, the outer edge of the sealing disk 14 is adapted such that the sealing element 14 essentially fills the channel cross section of the first channel 11, wherein only one clearance fit, which is exaggerated in the figures for reasons of illustration, is left is sufficiently large to allow a displaceability of the sealing element 14 in channel length. to enable the device. In a proximal spring part section 16 facing the sealing element 14, mutually adjacent turns of the cylinder compression spring 5 'are plastically deformed against each other. In the adjoining, remaining Federteillängenabschnitt 17 adjacent to each other turns of the cylinder compression spring 15 'spaced from each other, so that the spring element 15 in the Federteillängenabschnitt 17 in the longitudinal direction of the catheter line 2, starting from the preloaded mounting position in which the spring element 15 against the spring compressive force already compressed is even more compressible. In the first channel 11, a retaining tube 19 is inserted into the first channel 11 on the side opposite the sealing element 14, that is the distal side of the spring element 15, which is secured against displacement in the longitudinal direction L at least in the direction of the balloon 3. The holding tube 19 zuweisende longitudinal end of the spring element 15 is supported in the longitudinal direction L against the holding tube 19 from. The valve tube 13 and the holding tube 19 are thereby secured against unintentional displacement in the longitudinal direction L of the catheter line 2, that they each have a plurality of conical portions 20 on its outer side. The diameter of the extended longitudinal end 24 of these conical sections 20 is slightly larger than the inner diameter of the first channel 11, so that (see Fig. 5) the extended longitudinal ends engage like anchoring elements from the inside into the wall of the first channel 11 like a hook. The resulting securing of the valve tube 13 and the holding tube 19 is sufficient to prevent displacement due to the forces acting in the first channel 11 when used properly by fluid and / or spring force. The outer diameter of the cylinder compression spring 15 'is selected so that with the wall of the first channel 11 for a longitudinal displacement of spring coils in the longitudinal direction L just enough movement clearance results. For illustration, the annular gap surrounding the spring element is shown exaggeratedly large. The wall of the first channel 11 thus also forms a longitudinal guide for spring coils of the spring element 15 and (as described above) also for the sealing element 14. In this respect, the valve tube 13, the sealing element 14, the spring element 15 and the holding tube 19 act as valve parts in common with a length of the catheter line 2, a valve 28, whose operation will be discussed below.

In the example, it is provided that the catheter line 2 comprises three line sections 21, 22 and 23. The first line section 21 is firmly adhered to the connection device. The second line section 22 is fixedly connected to the balloon 3. The third line section 23, in which the valve 28 is formed, connects the first line section 21 to the second line section 22. A fixed connection is understood as meaning that, when the balloon catheter is used as intended, it is not detachable, at least not without the danger a damage or destruction is solvable.

To connect the three line sections 21-23 together, it is provided in the example that a first connection tube 46 is provided, which is firmly inserted in one longitudinal section into the first channel 11 at a respective longitudinal end of the first and third line sections 21, 23. a second connecting tube 47 is provided, which is firmly inserted in a respective longitudinal section into the first channel 11 at one longitudinal end of the second and third line sections 22, 23 such that a first connecting tube 48 is provided which in each case has a longitudinal section in the second Channel 12 is firmly inserted at each one longitudinal end of the first and the third line section 21, 23, and that a second connecting pipe 49 is provided, each in a longitudinal section in the second channel 12 at a respective longitudinal end of the second and the third line section 22, 23 is firmly inserted. Here too means firmly plugged turn that the connection in a proper use, at least not without the risk of damage or destruction, can be solved. In this context, in each case a seal 26 is applied by means of a sealing compound at the connection points 25 between said line sections. In the figures 1 and 2, the balloon catheter 1 according to the invention for clarity of illustration by means of two breaks 29, 30 shown shortened. The catheter line 2 comprises in the example, as mentioned, the three line sections 21, 22, and 23, wherein the valve 28 is located in the third line section 23. The length section of the first channel 11, which is located on the proximal side of the valve 28, that is, between the valve 28 and the connection device 6, is also referred to as the so-called first channel length section 31. In the region of the first channel length section 31, the balloon catheter 1 is shortened in FIGS. 1, 2 by an opening 29. The length portion of the first channel 11 extending on the distal side of the valve 28 between the valve 28 and the balloon 3 is also referred to as a so-called second channel length portion 32. In the second channel length section 32, the balloon catheter 1 is shown shortened in FIGS. 1, 2 by the breakaway 30. Through the risers 29 and 30 are integrally continuous longitudinal sections are not shown, which correspond to the respective adjacent areas. Insofar, however, it should be noted that the length of the catheter line between the valve 28 and the balloon 3 is preferably greater, preferably at least one order of magnitude greater than the line length of the catheter lead - tion 2 between the connection device 6 and the valve 28 is. In the example chosen, the proximal so-called first channel length section 31 has a length of about 9 cm and the distal, so-called second channel length section 32 a Length of about 2.2 m. The valve 28 is thus located near the proximal longitudinal end 10 of the catheter tube 2.

In the embodiment shown in the figures, the balloon catheter 1 comprises a protective sheath 41, which also serves as a kink protection. It surrounds the catheter line 2 in a longitudinal section 27 that extends from the connection device 6 in the direction of the balloon 3 beyond the valve 28 , In the example, the protective cover 41 is a piece of tubing made of an opaque material, which is attached or shrunk at its proximal longitudinal end in a longitudinal section on the distal, cylindrical end of the connecting device 6 with elastic expansion to achieve a clamping plug connection. In its longitudinal region adjoining the cylindrical end 37, the protective covering 41 loosely surrounds the catheter line 2, in that the inner diameter of the protective covering 41 is somewhat larger than the outer diameter of the catheter line 2. The protective cover 41 has a marking 39 on its outside. In the example, this is designed as a green color ring, which is to be distinguished clearly from the example in the example white ground color of the protective cover. Viewed in the longitudinal direction L of the catheter line 2, the marker 39 is located between the connecting device 6 and the valve 28. In Figure 3a is also (different from the other figures) indicated by the reference numeral 72 that on the protective cover 41 in addition to the marker additional information may be present, which further clarify a user that the balloon catheter 1 is cut to cut off the connection device 6 with a filled balloon 3 in a cross section, which is located in the region of the marking 39 of the protective cover 41. In the example, arrows 72 are printed on the protective cover 41, with the arrows 72 pointing to the marker 39 from both longitudinal sides. Preferably, in addition, even linguistic Indications on the protective cover 41 to be printed that is to be cut at the marking 39 and that subsequently the thereby loose part of the protective cover 41 is to be removed on the distal side of the cut. The valve 28 is only indicated in dashed lines in FIGS. 1 to 3, since it lies concealed in the interior of the catheter line 2. In comparison with FIG. 3 a, the protective cover 41 was not shown in FIG. 3 b for the present description. Thus, it can be seen that the catheter line 2 on the distal side of the valve 28 carries an outside marking 40 in a longitudinal section concealed intentionally by the protective covering 41 in FIG. 3a. In the example, it is a red color ring, which stands out clearly from the gray base color of the catheter line 2. The red marking is optically not visible from the outside through the protective cover 41.

The operation of the valve 28 will be explained with reference to FIGS. 4 to 7. These figures show the valve 28 in the first channel 11 of the catheter line 2. The valve 28 is adjoined proximally by the first channel length section 31 and distally by the so-called second channel length section 32, wherein in each of these figures only partial sections adjoining the valve 28 are shown. The first channel length section 31 extends in the longitudinal direction L of the catheter line 2 between the valve 28 and the connection device 6 and establishes a fluidic connection, ie a connection suitable for the passage of fluid, between the valve 28 and the connection device 6. The second channel length section 32 extends in the longitudinal direction L of the catheter line 2 from the valve 28 to an opening 42 laterally connecting the first channel 11 to the balloon interior 4 and, in the example, a short distance beyond the opening 42 to the distal longitudinal end of the first channel 11. In the second channel length section 32, the first channel 11 constitutes one fluidic connection between the valve 28 and the balloon interior 4 ago. The valve 28 is thus located between the first and the second channel length section. Thus, when the valve 28 is opened, the connector 6 is in continuous fluid communication with the balloon 3. On the other hand, when the valve 28 is closed, the connector 6 is not in fluid communication with the balloon 3. In the example shown, air is used as the fluid ,

FIG. 5 shows the initial situation corresponding to FIG. 1 prior to actuation of the air-filled syringe 18. The first channel 11 is filled with the fluid air, wherein the pressure Pi prevailing in the first channel length section 31 corresponds to the pressure P prevailing in the second channel length section 32 ₂ corresponds and both pressures can be equal to ambient pressure Po. The spring element 15, in the example the cylinder compression spring 15 ', is installed in the catheter line 2 or in the valve 28 in a prestressed state, that is to say compressed in the opposite direction to the spring force. This is achieved by the distance a between the valve tube 13 and the holding tube 19 measured in the longitudinal direction L of the catheter line 2 being somewhat smaller than the sum of the length b of the spring element 15 in the relaxed state and the thickness c of the sealing element 14. It follows in that the spring element 15, with its proximal end face 51 in the state of use shown in FIG. 5, presses the sealing element 14 parallel to the longitudinal direction L against the valve tube 13, whereby it lies between the annular, distal end face 52 of the valve tube 13 and the circular proximal end face 53 of the sealing element 14 comes to a seal. The outer diameter of the distal end surface 52 corresponds to the inner diameter of the first channel 11 in the example, and the outer diameter of the sealing element 14 is only minimal smaller, so that just the desired displaceability of the sealing element 14 results in the longitudinal direction L; 5, the valve 28 is in the closed position, with no or at most a very slow exchange of fluid (for example air) between the first channel length section 31 and the second channel length section 32 is possible. This also corresponds to the use state shown in FIG.

FIG. 6 shows the valve 28 in a state of use during the filling of the balloon 3 with fluid (in the example with air). Fluid has been supplied into the first channel length portion 31 by means of the syringe 18 so that the pressure Pi effective there and consequently in the cavity 20 of the valve core 13 is greater than the pressure P ₂ in the second channel length portion. The direction of the pressure drop 33 is indicated by an arrow. The overpressure acting in the first channel length section 31 presses against the sealing element 14 in the distal direction. If a sufficiently high amount of differential pressure, which exceeds the spring force of the pretensioned spring element 15, arises due to the fluid supply, the sealing element is displaced in the longitudinal direction L as a result of the pressure difference. With the repeal of the sealing zone 54 or the sealing action, a valve gap 35 is formed between the distal end face 52 of the valve tube 13 and the proximal end face 53 of the sealing element 14. Between the outer edge of the sealing element 14 and the wall of the first channel 11 As already mentioned, only a slight circumferential gap 55 which enables the longitudinal displacement and which is permeable to fluid, in the example of air, is formed. Also between the outside of the spring element 15 and the wall of the first channel 11, a circumferential gap 56 is formed. The circumferential gaps are shown exaggerated for illustration. In addition, extends through the spring element 15 parallel to the longitudinal direction The circumferential gap 56 and the center channel 57 are in a fluid, so for a fluid-permeable, connection with the circumferential gap 55 and with a passing through the holding tube 19 in the longitudinal direction L longitudinal channel 58. The valve tube 13 has a longitudinal direction L, as shown in Figure 6, the sealing element 14 from its sealing position away from the valve tube 13 (lifted in the longitudinal direction L) is formed by the valve gap 35, a fluidic connection between the longitudinal channel 59 and the circumferential gap 55, which in turn is fluidly connected by means of the circumferential gap 56 and the middle channel 57 with the longitudinal channel 59. In this so-called open position of the valve 28, this has a comparatively low flow resistance for fluid (in the example of air) in the direction of the pressure gradient 33 pointing from the proximal to the distal direction. The first channel length section 31 is then fluidically connected to the second channel length section 32. In FIG. 6, arrows 36 indicate the flow path along which the fluid from the first channel length section 31 can flow into the second channel length section 32 in order to pump up the balloon 3 with fluid. When the valve 28 is open, consequently, the first connection 7 is in continuous fluid communication with the balloon interior 4 by means of the first channel 11.

FIG. 7 shows the valve 28 in a still further state of use which, in a preferred application, follows the state of use shown in FIG. 6 and which is to be assigned to the situation in FIG. This can be achieved after the fluid supply has been terminated and, in particular, even when the catheter line 2 is cut through between the valve 28 and the connection device 6, for example, was cut through. The pressure P ₂ acting in the second channel length section 32 is greater than or equal to the pressure Pi acting in the first channel length section 31, so that either no Pressure gradient or now in the direction of arrow 33 from distal to proximal directed pressure gradient results. The pressure Pi has fallen so far that now the pressure difference between P ₂ and Pi and the spring force act together in the proximal, ie in the direction of the connection device 6, direction, whereby the spring element 15, the sealing element 14 again presses sealingly against the valve tube 13 , At these pressure conditions, the valve 28 thus returns elastically independently in its previous or original position. In this case, either a complete or an almost complete sealing effect can be achieved. For example, the pressure P _{2 may be} as large as before the pressure Pi during the fluid supply, while now the pressure Pi, for example, as large as the ambient pressure (ie as the pressure P ₂ before the fluid supply) may be. Although the differential pressure amount between P ₂ and Pi corresponds to the differential pressure amount of FIG. 6 at the start of the fluid supply, no fluid or, depending on the concrete embodiment, almost no or only a considerably lower one compared to FIG Volume flow of fluid through the valve 28. On the basis of the described example, it is clear that the flow resistance of the valve 28 in the direction of the pressure gradient 33 of Figure 7 is less than the flow resistance of the valve 28 in the direction of the pressure gradient 33 of Figure 6, ie at inverse pressure conditions , As a result of this complete or partial (in particular almost complete) sealing action of the valve 28 in the closed position shown in FIG. 7, the overpressure effective in the second channel length section 32 and in the balloon 3 is either maintained over the long term or degrades only slowly. Thus, the balloon 3 remains at least for a certain period of time in an inflated or expanded state. From Figures 1 and 2, in conjunction with the sectioned figures lb and 2b show that in the catheter line 2, the first channel 11 does not extend all the way to the distal longitudinal end 5, but with its local longitudinal end by means of a lateral opening 42 in fluid communication with the balloon interior 4 is. The balloon 3 is formed adjacent to the distal longitudinal end 5 of the catheter tube 2. In the example, the balloon envelope 43 is formed from a latex tubular piece, the two longitudinal ends of which are each pressed by a winding 44 of a thin metal wire from the outside sealing against the catheter tube 2. As an alternative to this embodiment of the balloon 3 on the catheter line 2, each of the two windings 44 may, for example, be replaced by a ring, preferably of platinum or iridium, in order to be able to recognize the balloon 3 in x-ray images. FIG. 1 shows a state of use before the supply of fluid, wherein the elastic balloon sheath 43 extends in a relaxed state almost parallel to the catheter line 2, so that the balloon interior 4 is only an annular gap. Figure 2 shows a state of use after the supply of fluid in which the balloon is inflated so far that its cross-sectional diameter is a multiple of the diameter of the catheter line 2. The second channel 12 of the catheter conduit 2 extends from the connector 6 to an end opening 45 formed at the distal longitudinal end 5. In the example chosen, the catheter conduit 2 is made of composite material containing polyamide and bismuth.

It is clear from FIGS. 4 to 7 that, in the exemplary embodiment, the proximal end face 51 of the spring element 15 is oriented perpendicular to the geometric spring longitudinal center line (not shown), so that the proximal end face 51 extends annularly over the entire or substantially entire circumference the distal end face 67 of the sealing element 14 can be supported in order to avoid tilting and thereby blocking. The Position of an at least predominantly in-plane spring end face is simplified by the plastically compressed turn at this longitudinal end. With reference to FIGS. 9 to 12, various states of use of the balloon catheter 1 shown in FIGS. 1 to 8 are shown by way of example during exemplary applications.

In the state of use shown in FIG. 9, a guide wire 60 was first guided distally through the working channel of a first comparatively thick endoscope 63 until the distal longitudinal end of the guide wire 60 reaches a desired position in a schematic through boundary walls 64 indicated cavity 65 is located in a human or animal body. Along the advancing guidewire 60, the balloon catheter 1 was passed through the working channel of the endoscope 63 with a pressureless, ie, slender, balloon 3 until the balloon 3 is in a desired position in the cavity 65. The guidewire 60 may be passed through the channel 12 for this purpose. In this position, the fluid in the syringe 18 (in the example air) was directed into the balloon 3 through the first channel 11 in the manner previously described, thereby expanding, as shown in Figure 9, and thereby between the confining walls 64 braced. The balloon 3 thereby anchors the balloon catheter 1 in the region of its distal longitudinal end 5, so that unintentional displacement of the balloon catheter 1, in particular in its longitudinal direction L, is effectively prevented. 9, the balloon diameter is greater than the diameter of the working channel in the endoscope 63. The cross-sectional dimensions of the connection device 6 are greater than the cross-section of the working device. Beitskanals, so that the endoscope 63 in a case of need can not be removed in the proximal direction. In order to make this possible, however, after the removal of the guide wire 60, it is possible to sever the balloon catheter 1 at its marking 39, for example by cutting it with a knife. The resultant state is shown in FIG. 10. The lengthwise section of the protective covering 41 adjoining the marking 39 surrounds the catheter line 2 only loosely, so that this length section can be moved freely along the catheter line 2. In Figure 11, this freely displaceable portion of the protective cover 41 has been removed. The valve 28 is still in the connected to the balloon 3 length of the catheter line 2 and retains its closed position, so that the balloon 3 remains inflated and maintains its anchoring effect.

In this state, the marking 40 becomes visible on the catheter line 2 and, as a comparison of FIGS. 10 and 11 shows, the first endoscope 63 is withdrawn in the proximal direction from the catheter line 2 and, for example, against a comparatively slimmer one shown in FIG. Endoscope 66 are replaced, through the working channel, the catheter line 2 can be passed again. The inflated balloon 3 retains its position.

Only when, as shown in FIG. 12, the catheter line 2 is subsequently severed, for example cut, at the marking 40, is the valve 28 separated from the catheter line 2 connected to the balloon 3. This causes the fluid to escape rapidly from the balloon 3, so that the balloon 3 can be contracted in a controlled manner and the balloon catheter 1 can be withdrawn from the cavity 65 and, in particular, from the endoscope 66. From the foregoing description it is clear that in the new state of the balloon catheter 1 shown in the figures, only the marker 39, but not the marker 40 is visible. This significantly reduces the risk of misoperation in which the catheter line 2 is not severed as desired first on the proximal side of the valve 28, but first on the distal side of the valve 28.

It will be understood from the foregoing description that the balloon 3 will remain trapped between the boundary walls 64 during the exemplary use shown in the figures until the valve 28 is cut off, or as long as the balloon 3 is inflated and thereby expanded, and thus during the endoscope - Replacement remains unchanged in the desired position in the cavity 65. As a result of this anchoring of the balloon 3, it can be achieved that the balloon catheter 1 does not shift in the longitudinal direction L during the exchange of the endoscopes 63, 64. Only a contraction of the balloon 3 eliminates this holding effect, so that the positional fixation is canceled and the balloon 3 between the boundary walls 64 out and can be withdrawn through the last used endoscope 66 therethrough. It is understood that there are other ways to use.

For certain applications, it may be advantageous if the balloon 3 can be refilled with air after separation of the valve 28 and thereby expanded. For example. Such a refilling of the balloon 3 can take place directly at the still unchanged position between the boundary walls 64 of a body cavity 65. It would also be possible to refill the balloon 3 at a different location in the body. A filling device 74 suitable for this purpose, which is also to be designated as a refilling device with regard to this preferred function, will first be referred to to the figures 13 to 15, where the representation is enlarged compared to the preceding and following figures. The filling device 74 comprises a hollow needle 75 and a housing 76 sealingly connected to the hollow needle 75, which in the example is made of plastic. The filling device 74 has, on the proximal side opposite to the hollow needle 75, a connection 77 which allows the detachable connection of a syringe 18 (see FIG. Inside the housing 76, a hollow fluid passage 78 extends distally to the hollow needle 75 and proximally to the port 77 in fluid communication. In the housing 76 and in the fluid passage 78, a shut-off valve 79 is used, the valve body can rotate by means of a rotary handle 80 selectively in a rotational position in which a through hole in the valve body of a fluid (or air) through-flow connection between the on forms both sides of the check valve 79 (ie, before and behind) located portions of the fluid iddurchdurch 78, or in another rotational position in which the valve body separates these two sections from each other sealingly. The fluid passage 78 is thus by means of the check valve 79 either for the passage of fluid from the syringe 18 apparently closed or to prevent fluid passage. In the example, however, it would be possible to dispense with the shut-off valve 79, since the syringe 18 can be sealingly connected to the housing 76 and the syringe piston is also guided sealed in the syringe housing. The outer diameter u of the hollow needle 75 is selected by only a few hundredths of a millimeter, ie only slightly larger than the inner diameter v of the first channel 11 of the elastic catheter line 2. In FIGS. 13, 14, a stylet 81 is passed through the filling device 74. The stylet 81 comprises a wire section 82 and a proximal handle section 83. The wire section 82 extends through the port 77, the fluid passage 78, the open shut-off valve 79 and the hollow needle 75 and stands with its discrete longitudinal end 84 over the top of the hollow needle 75. In FIG. 15, the stylet 81 is removed from the filling device 74 and a syringe 18 sealingly connected to the connection 77. FIGS. 16, 17 show, by way of example, how, for example, starting from the state of use of the balloon catheter 1 according to FIG. 12, the filling device 74 can be used to refill or expand the balloon 3. For this purpose, FIG. 16 shows the proximal longitudinal end 68 of a longitudinal section 69, which is still firmly connected to the balloon 3, of the catheter line 2, which was formed in the region of the marking 40 when the valve 28 was separated. There, the first channel 11 and the second channel 12 are free frontally. FIG. 16 shows that the filling device 74 with the stylet 81 inserted therein is inserted in the first channel 11 in the direction of movement of the arrow 70 at the proximal end 68. The wire section 82, whose diameter is smaller than the outer diameter u of the hollow needle 75, serves as a threading aid. The hollow needle 75 is inserted with the application of a certain longitudinal force in the first channel 11, which is thereby somewhat elastically widened according to the described diameter ratios, so that it finally surrounds the hollow needle 75 while achieving a plug-clamp connection 71. FIG. 17 shows that after inserting the hollow needle 75 into the first channel 11, the stylet 81 can be removed and a syringe 18 can be connected to the connection 77. 17 shows a use state in which the air from the syringe 18 has already been pumped by means of the filling device 74 into the first channel 11 of the catheter line 2 and through the first channel 11 into the balloon 3, which has thus been refilled and expanded, so that a desired clamping effect or position fixation between the boundary walls 64 of the body cavity 65 is achieved. To get this condition (even with the ability to remove the syringe 18), the Shutoff valve 79 are rotated in its closed position. In order to be able to vent or contract the balloon 3 again so that it can be removed from the cavity 65, there is the possibility that the hollow needle 75 is pulled out of the catheter line 2 or that the shut-off valve 79, in particular with the syringe 18 removed , is again twisted in its open position. The balloon 3 is attached to the catheter tube 2 in the manner shown in FIG. 2 b, ie, the catheter tube 2 extends through the interior of the balloon 3. In uncut views of the balloon 3 (such as in FIG. 17) is shown in FIG the figures of the section of the catheter line 2 leading through the balloon 3 are not shown in the overview, although the balloon envelope can also consist, for example, of a translucent material.

The balloon catheter 1 formed by the use described by way of example, shown in FIG. 17, comprises a catheter line 2, an expansible balloon 3 which borders a balloon interior 4 and is arranged or arranged on the catheter line 2, and a filling device 74 for the balloon 3 Catheter lead 2 has a proximal longitudinal end 68 from which it extends in its longitudinal direction L to its distal longitudinal end 5 on which or to which the balloon 3 is adjacent. In the catheter line 2 extends in its longitudinal direction L of the first channel 11 which is fluidly connected to the balloon interior 4. At the proximal longitudinal end 68 of the catheter line 2, the first channel 11 opens into an end opening. Due to this, the hollow needle 75 is in a certain length in the first channel 11 of the catheter line 2 to achieve a

Plug-clamp connection 71 inserted. In the example, ie not necessary, viewed in the longitudinal direction L, the total length of the valve 28, including the valve tube 13 and the holder terotube 19, is 10 mm. The valve tube 13 and the holding tube 19 each have a length of 2.2 mm. The thickness denoted by c of the sealing element 14 in the example is 0.2 mm. By way of example, a length of 30 mm is selected for the third line section 23, in which the valve 28 is located. The outer diameter d of the catheter line 2 in the example is 1.85 mm, while the inner diameter di of the first channel 11 is by way of example 0.45 mm and the inner diameter of the second channel 12 is exemplary 0.95 mm. The diameter of the through channels in the valve tube 13 and in the holding tube 19 is exemplarily 0.3 mm. It is understood that other numerical values could be chosen for all dimensions. For mounting the described valve 28, the spring element 15 and the sealing element 14 in the first channel 11 längsverschieb- borrowed used. The valve tube 13 and the holding tube 19 are pressed with each tapered longitudinal end in the longitudinal direction L in the first channel 11 and pressed therein to the desired position in which the sharp-edged conical extensions 24 prevent retreating in the opposite direction. Alternatively, it is conceivable that the valve tube 13 and the holding tube 19 have no conical projections, but, for example, a cylindrical outer circumferential surface. Their diameter can be selected slightly larger than the inner diameter of the first channel, so that when inserting into the first channel results in a positional securing according to a press fit, possibly even with elastic expansion of the catheter line.

The above explanations serve to explain the total of the application covered inventions, the prior art, at least each independently by the following feature combinations, namely:

A balloon catheter 1, which is characterized in that in the first channel 11 between the first channel length portion 31 and the second channel length portion 32, a valve tube 13 is arranged and secured against displacement at least in the direction of the connection means 6 that in the first channel 11, a sealing element 14 adjacent to the second channel length portion 32 nearer longitudinal end of the valve tube 13 and slidably disposed in the longitudinal direction of the first channel 11, that in the first channel 11 adjacent to the sealing element 14 on its side opposite to the valve tube 13 side a spring element 15, in particular a cylinder compression spring is arranged, wherein the farther from the sealing element 14th

Longitudinal end of the spring element 15 is secured against displacement at least in the direction of the balloon and wherein the sealing element 14 closer longitudinal end of the spring element 15, the sealing element 14 by means of spring force in the direction of the valve tube 13 suppressed.

A balloon catheter 1, characterized in that the balloon catheter 1 comprises a protective sheath 41 which surrounds the catheter conduit 2 in a longitudinal portion 27 which extends from the attachment means 6 towards the balloon 3 beyond the valve 28, and the protective cover 41 has an externally perceptible marking 39, in particular a visible ring in a first color, which is located between the connecting device 6 and the valve 28.

A balloon catheter 1, which is characterized in that in the first channel 11 between the first channel length section 31 and the second channel length genabschnitt 32 a valve member is arranged, which forms a valve 28 with the surrounding wall of the first channel 11, or that in the first channel 11 between the first channel length portion 31 and the second channel length portion 32 a plurality of valve parts are arranged, with the surrounding wall of the first channel 11 form a valve 28, or that in the first channel 11 between the first channel length portion 31 and the second channel length portion 32, a valve 28 is arranged, that the flow resistance of the valve 28 for fluid upon application of a pressure gradient, wherein the fluid pressure in see the first channel length portion 31 of the first channel 11 between the valve 28 and the connecting device 6 by a certain differential pressure amount greater than in the second channel length portion 32 of the first channel 11 between the valve 28 and the balloon interior 4, in the direction of this pressure gradient is less than in case of concern of a entgegengeset pressure gradient, in which the fluid pressure in the first channel length segment 31 is smaller than in the second channel length section 32 by this differential pressure amount, in the direction of this opposite pressure gradient that the balloon catheter 1 has a protective sleeve 41 which covers the catheter line 2 in a longitudinal section 27, which extends from the connection device 6 in the direction of the balloon 3 beyond the valve 28 and surrounds, and that the protective cover 41 has an externally perceptible marking 39, in particular a visible ring in a first color, which extends between the connection device 6 and the valve 28 is located.

A balloon catheter 1, which is characterized in that at least the following valve parts are arranged in the first channel 11 between the first channel length section 31 and the second channel length section 32:

a valve tube 13 which is secured against displacement at least in the direction of the connection device 6, a sealing element 14, which is displaceable adjacent to the longitudinal end of the valve tube 13 closer to the second channel length section 32 and in the longitudinal direction L of the first channel 11,

- A spring element 15, in particular a cylinder compression spring, adjacent to the sealing element 14 at its the valve tube 13 opposite

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wherein the longitudinal end of the spring element 15 farther from the sealing element 14 is secured against displacement at least in the direction of the balloon 3 and wherein the longitudinal end of the spring element 15 closer to the sealing element 14 pushes the sealing element 14 towards the valve tube 13 by means of spring force.

A balloon catheter 1, which is characterized in that the catheter line 2 extends within a longitudinal section which extends from the valve 28 to the distal longitudinal end 38 of the protective cover 41, a marking 40, in particular a visible ring in a second, of the first color of different color, has.

A balloon catheter 1, which is characterized in that the marking 40 of the catheter line 2 is not visible from outside through the protective cover 41.

A balloon catheter 1, which is characterized in that the protective cover 41 is fastened at its proximal longitudinal end 50 to the connection device 6, in particular releasably secured, in particular attached to the connection device 6, and that the protective cover 41, the catheter line 2 at least in one Longitudinal section 27, in which the valve 28 and the mark 40 of the Catheter line 2 are arranged, loosely surrounding with respect to the cross-sectional dimensions.

A balloon catheter 1, which is characterized in that the sealing element 14, the channel cross-section of the first channel 11 completely fills or fills, leaving only a clearance for the displacement of the sealing element 14 in the channel longitudinal direction forming edge gap.

A balloon catheter 1, which is characterized in that the spring element 15 has a linear spring characteristic or a progressive spring characteristic.

A balloon catheter 1, which is characterized in that mutually adjacent turns of the cylinder compression spring in a sealing member 14 facing the spring member portion 16 abut each other and extend at least in a central Federteillängenabschnitt spaced from each other.

A balloon catheter 1, which is characterized in that in the first channel 11 on the side opposite the sealing element 14 side of the spring element 15, a retaining tube 19 is arranged, which is secured against displacement at least in the direction of the balloon 3 and wherein the retaining tube 19 assigning longitudinal end of the spring element 15 against the holding tube 19 is supported.

A balloon catheter 1, which is characterized in that the valve tube 13 and / or the holding tube 19 is or are held in the longitudinal direction L by means of a press fit in the first channel 11 and / or that the valve tube 13 and / or the holding tube 19 has on its outer jacket a or more Having anchoring projections or, in particular, it is provided that the anchoring projections taper conically.

A balloon catheter 1, which is characterized in that the catheter line 2 comprises three line sections 21, 22, 23, wherein a first line section 21 fixedly attached to the connection device 6, in particular glued to the connection device, pressed, fused or the like, and wherein the balloon 3 is formed on the second conduit section 22 and wherein the third conduit section 23, in which the valve 28 is located, connects the first and the second conduit sections 21, 22 to one another.

A balloon catheter 1, which is characterized in that a first connecting tube 46 is provided, which is firmly inserted in a respective length in the first channel 11 at a respective longitudinal end of the first and third line section 21, 23 that a second Verbindungsr A tube 47 is provided, which is firmly inserted in a respective longitudinal section in the first channel 11 at a respective longitudinal end of the second and the third line section 22, 23, that a first connecting tube 48 is provided which in each case a longitudinal section in the second channel 12th at a respective longitudinal end of the first and third line section 21, 23 is firmly inserted, and that a second connecting pipe 49 is provided, each in a longitudinal section in the second channel 12 at a respective longitudinal end of the second and the third line section 22, 23 is firmly inserted. A balloon catheter 1, which is characterized in that at the connection points 25 between the first and the third line section 21, 23 and at the connection point 25 between the second and the third line section. tion section 22, 23, a seal 26, in particular by means of sealing compound or adhesive or cohesive connection is formed.

A balloon catheter 1, which is characterized in that a filling device 74 is present, which comprises a hollow needle 75 and a housing 76 adjoining thereto, wherein at the filling device 74 at least one connection 77 for supplying fluid, such as Air, in particular for the releasable attachment of a syringe 18 or a fluid line or the like, is formed so that a in the housing 76 extending fluid passage 78 is in fluid communication with the port 77 and the hollow needle 75, and that the outer cross section, in particular the outer diameter u, the hollow needle 75 is slightly larger than the inner cross-section, in particular as the inner diameter v, of the first channel 11 of the catheter line 2. All disclosed features are essential to the invention. The disclosure of the associated / attached priority documents (copy of the prior application) is hereby also incorporated in full in the disclosure of the application, also for the purpose of including features of these documents in claims of the present application. The subclaims characterize with their features independent inventive developments of the prior art, in particular to make on the basis of these claims divisional applications.

Claims

CLAIMS:

A balloon catheter (1) comprising a catheter conduit (2), a distensible balloon (3) bounding a balloon interior (4) and formed on the catheter conduit (2), and connector means (6) having at least a first one Has a connection (7) for supplying fluid and which is arranged on the catheter line (2), extending in the catheter line (2) in its longitudinal direction (L) extending at least a first channel (11), at least in a first channel length portion (31) is in fluid communication with the first port (7) and is at least in a second channel length portion (32) in fluid communication with the balloon interior (4), characterized in that in the first channel (11) between the first channel length portion (31) and the second channel length section (32), a valve tube (13) is arranged and secured against displacement at least in the direction of the connection device (6) that in the first channel (11) ei n sealing element (14) adjacent to the second channel length portion (32) closer longitudinal end of the valve tube (13) and longitudinally displaceable in the longitudinal direction of the first channel (11) that in the first channel (11) adjacent to the sealing element (14) a spring element (15), in particular a cylinder compression spring, is arranged, the longitudinal end of the spring element (15) remote from the sealing element being secured against displacement at least in the direction of the balloon, and wherein the the sealing element (14) closer longitudinal end of the spring element (15) presses the sealing element (14) by means of spring force in the direction of the valve tube (13). A balloon catheter (1) according to claim 1, characterized in that the balloon catheter (1) comprises a protective sheath (41) which surrounds the catheter conduit (2) in a length portion (27) extending from the attachment means (6) towards the balloon (3) extends beyond the valve (28), surrounds, and that the protective sheath (41) has an externally perceptible marking (39), in particular a visible ring in a first color, which extends between the connecting device (6) and the valve (28).

A balloon catheter (1) comprising a catheter conduit (2), an expandable balloon (3) bounding a balloon interior (4) and formed on the catheter conduit (2), and connector means (6) defining the at least one first port (7 ) for the supply of fluid and which is arranged on the catheter line (2), wherein extending in the catheter line (2) in its longitudinal direction (L) extending at least a first channel (11) at least in a first channel length portion (31) is in fluid communication with the first port (7) and in fluid communication with the balloon interior (4) in at least one second channel length section (32), characterized in that in the first channel (11) between the first channel length section (31) and the second channel length portion (32) is arranged a valve member which forms a valve (28) with the surrounding wall of the first channel (11), or that in the first channel (11) between the e A plurality of valve parts are arranged along the channel length section (31) and the second channel length section (32), forming a valve (28) with the surrounding wall of the first channel (11), or in the first channel (11) between the first channel length section (32). 31) and the second channel length section (32) a valve (28) is arranged, that the Durchstr. flow resistance of the valve (28) for fluid upon application of a pressure gradient, wherein the fluid pressure in the first channel length portion (31) of the first channel (11) between the valve (28) and the connecting device (6) by a certain differential pressure amount greater than in the second channel length section (32) of the first channel (11) between the valve (28) and the balloon interior (4) is less in the direction of this pressure gradient than when a pressure gradient opposite thereto is present, in which the fluid pressure in the first channel length section (31) is less than in the second channel length section (32), in the direction of this opposite pressure gradient, that the balloon catheter (1) has a protective sheath (41), the catheter line (2) in a longitudinal portion (27) extending from the Connecting device (6) in the direction of the balloon (3) extends beyond the valve (28) addition, surrounds and that the protective cover (41) has a v on the outside perceptible

Marking (39), in particular a visible ring in a first color, which is located between the connecting device (6) and the valve (28).

Balloon catheter (1) according to claim 3, characterized in that at least the following valve parts in the first channel (11) between the first

Channel length portion (31) and the second channel length portion (32) are arranged:

a valve tube (13) secured against displacement at least in the direction of the connection device (6),

- A sealing element (14) adjacent to the said second channel length portion (32) closer longitudinal end of the valve tube (13) and in the longitudinal direction (L) of the first channel (11) is displaceable, a spring element (15), in particular a cylinder compression spring, adjacent to the sealing element (14) on its side opposite the valve tube (13),

wherein the longitudinal end of the spring element (15) farther from the sealing element (14) is secured against displacement at least in the direction of the balloon (3) and wherein the sealing element (14) closer longitudinal end of the spring element (15) the spring element (14) towards the valve tube (13).

A balloon catheter (1) according to one or more of the preceding claims, characterized in that the catheter conduit (2) has a mark within a length extending from the valve (28) to the distal longitudinal end (38) of the protective sheath (41) (40), in particular a visible ring in a second, different from the first color color has.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that the marking (40) of the catheter line (2) from the outside through the protective cover (41) is not visible therethrough.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that the protective cover (41) at its proximal longitudinal end (50) attached to the connection device (6), in particular releasably secured, in particular on the connection device (6) is plugged in that the protective sheath (41) covers the catheter line (2) at least in a longitudinal part section (27) in which the valve (28) and the Mark (40) of the catheter line (2) are arranged, loosely surrounds with respect to the cross-sectional dimensions.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that the sealing element (14) completely fills the channel cross-section of the first channel (11) or fills it, leaving only a clearance gap forming a clearance fit for displacement of the sealing element (14) in the channel longitudinal direction ,

Balloon catheter (1) according to one or more of the preceding claims, characterized in that the spring element (15) has a linear spring characteristic or a progressive spring characteristic.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that mutually adjacent turns of the cylinder compression spring in a sealing element (14) facing the spring member portion (16) abut each other and at least in a central Federteillängenabschnitt spaced from each other.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that in the first channel (11) on the side opposite to the sealing element (14) side of the spring element (15), a retaining tube (19) is arranged which against displacement at least is secured in the direction of the balloon (3) and wherein the retaining tube (19) facing the longitudinal end of the spring element (15) against the retaining tube (19) is supported.

12. Balloon catheter (1) according to one or more of the preceding claims, characterized in that the valve tube (13) and / or the holding tube (19) by means of press fit in the first channel (11) in the longitudinal direction (L) is or are and / or that the valve tube (13) and / or the holding tube (19) has or have on its outer jacket one or more anchoring projections, wherein it is provided, in particular, that the anchoring projections taper conically. 13. Balloon catheter (1) according to one or more of the preceding claims, characterized in that the catheter line (2) comprises three line sections (21, 22, 23), wherein a first line section (21) fixedly attached to the connection device (6), in particular, bonded, pressed, fused or the like with the connecting device, and wherein the balloon (3) is formed on the second conduit section (22) and wherein the third conduit section (23) in which the valve (28) is located first and the second line section (21, 22) interconnects. 14. Balloon catheter (1) according to one or more of the preceding claims, characterized in that a first connecting tube (46) is provided, each in a longitudinal section in the first channel (11) at each one longitudinal end of the first and the third line section ( 21, 23) is firmly inserted, that a second connecting tube (47) is provided, which is firmly inserted in a respective length in the first channel (11) at a respective longitudinal end of the second and the third line section (22, 23) a first connecting pipe (48) is provided, which in each case a longitudinal section in the second channel (12) at a respective Longitudinal end of the first and the third line section (21, 23) is firmly inserted, and in that a second connecting tube (49) is provided, each in a longitudinal section in the second channel (12) at each one longitudinal end of the second and the third line section ( 22, 23) is firmly inserted.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that at the connection points (25) between the first and the third line section (21, 23) and at the connection point (25) between the second and the third line section (22 , 23) a seal (26), in particular by means of sealing compound or adhesive or cohesive connection is formed.

Balloon catheter (1) according to one or more of the preceding claims, characterized in that a filling device (74) is present, which comprises a hollow needle (75) and a subsequent housing (76), wherein at the filling device (74) at least one connection (77) for supplying fluid, such as air, in particular for releasably attaching a syringe (18) or a fluid conduit or the like is formed, that in the housing (76) extending fluid passage (78) in fluid communication with the connection (77) and with the hollow needle (75) is, and that the outer cross section, in particular the outer diameter (u) of the hollow needle (75) is slightly larger than the inner cross section, in particular as the inner diameter (v) of the first channel (11 ) of the catheter lead (2).

17. Balloon catheter (1), characterized by the characterizing features of one of the preceding claims.