WO2013153050A2

WO2013153050A2 - Balloon catheter and method for the use thereof

Info

Publication number: WO2013153050A2
Application number: PCT/EP2013/057362
Authority: WO
Inventors: Wolfgang Haag
Original assignee: M T W - Endoskopie W. Haag Kg
Priority date: 2012-04-10
Filing date: 2013-04-09
Publication date: 2013-10-17
Also published as: DE102012109894A1; WO2013153050A3

Abstract

The invention relates to a balloon catheter (1), comprising a catheter line (2), a stretchable balloon (3), which is formed on the catheter line (2), and a connection apparatus (6), which has at least a first connector (7) for supplying fluid and which is arranged on the catheter line (2), wherein at least a first channel extends in the catheter line (2), which first channel, at least at the one longitudinal end thereof, has a fluidic connection to the first connector (7) and, at least in a different channel length section, has a fluidic connection to the balloon interior (4). For an advantageous development, it is proposed that a valve insert (13) having a tubule is inserted into the first channel, wherein a cavity, which is present in the tubule in a channel extending in the longitudinal direction thereof, extends as far as at least one end-side opening of the tubule in the direction towards the connection apparatus (6) and as far as a seal of the channel in the direction towards the balloon (3), and wherein at least one passage opening is formed, which leads across the lateral wall of the tubule, opens into the cavity in the tubule and has a fluidic connection to the end-side opening. The invention moreover relates to a method for using a balloon catheter (1).

Description

Balloon catheter and method of use

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, in particular at one longitudinal end or in the vicinity thereof, and a connection device which has at least one first connection for fluid supply and the is arranged on the catheter line in particular at the other longitudinal end or in the vicinity thereof, wherein extending in the catheter line in its longitudinal direction extending at least a first channel, which is in fluid communication with the first port and with the balloon interior.

Such a balloon catheter is known in the art from US 2011/0118546 AI. There, it is described 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 medium and a guidewire (stylet) having proximal connection device of the balloon catheter can not be guided through the working channel due to their dimensions. However, in order to facilitate a desired exchange of endoscopes in which the balloon catheter with expanded and quasi-anchored balloon in the bile duct serves as a guide, proposes US 2011/0118546 AI, that the terminating means by means of a suitable coupling and valves of the remaining balloon catheter As often as you want to be coupled and uncoupled. The designs proposed in US 2011/0118546 AI are complex and expensive.

Against this background, the invention has the object, advantageously develop a balloon catheter of the type mentioned. par- In particular, a use-advantageous further training and application improvement is sought.

The object is achieved according to the invention firstly and essentially in conjunction with the features that in the first channel a valve insert is inserted which comprises a tube, wherein a cavity which is present in the tube in a channel extending in its longitudinal direction, extending in the direction of the connection device up to at least one frontal opening of the tube and extending in the direction of the balloon to a closure of the channel, and wherein at least one transverse through the jacket wall of the tube leading, opening into the cavity in the tube through opening formed which is in fluid communication with the frontal opening thereof by means of the cavity in the tube. With regard to the handling of the balloon catheter, according to customary usage, the balloon is located at its distal longitudinal end and the connecting device accordingly at the proximal longitudinal end. The valve insert forms, with the preferably elastically deformable wall of the first channel or the catheter line, a valve which is effective in the first channel. The fluid supplied by the first port through the first port serves to supply it to the balloon or its interior as required, thereby elastically expanding the balloon sheath and inflating the balloon for expansion. Preferably, the fluid is air. In order to supply the fluid, the connection may have a connection opening and connection means for the releasable attachment of a fluid source, such as, for example, a compressed-air syringe. If fluid or compressed air is supplied to the first channel with the compressed-air syringe, it flows through the open longitudinal end of the tube oriented toward the proximal end and pushes it from the inside in the region of the passage opening against the elastic wall of the first channel formed by the catheter line. Preferably, the cross-section of the tube is sized so large that the tube is compliant Wall of the first channel expands slightly, so that the resilient wall according to their elasticity frictionally rests from the outside of the tube. While the flexible wall of the first channel firmly surrounds the tube at the circumference of the elastic expansion of the wall before the start of the fluid supply, an increased inside the tube fluid pressure causes the wall of the first channel in the region of the passage opening elastically slightly radially outward expands and partially lifts off the tube. This forms a fluid path between the outer surface of the tube and the inner surface of the wall of the first channel. The valve formed by the valve insert with the surrounding wall of the first channel of the catheter line is therefore permeable and is in an open position for the fluid when the pressure of the fluid in a first channel length portion of the first channel, located on the proximal side of the valve, Thus, between the valve and the port device is greater than the pressure in a second channel length portion of the first channel, which extends on the distal side of the valve between the valve and the balloon. After the balloon has been inflated to a desired diameter or internal pressure, the supply of the fluid can be stopped. When the pressure of the fluid in the first channel length section approaches or equals or falls below the pressure of the fluid in the second channel length section, the wall of the first channel deforms back to its original shape in the region of the passage opening of the tube, whereby the wall of the first channel along the entire circumference again fits tightly against the tube. The fluid path previously formed by the radial expansion is thus closed again, and the valve is automatically in a closed position, in which there is only a comparatively little or no permeability to the fluid in the direction of the then acting pressure gradient depending on the design and effective pressure has. The expansion of the balloon thus remains even after termination of the fluid supply, at least for a certain period, preserved. loading Preferred is an embodiment in which an expansion of the balloon after a pressure drop in said first channel length section is still retained for a period of at least four to five minutes, at least approximately.

Based on the generic type balloon catheter mentioned above, the object is accordingly achieved according to a more general aspect of the invention in conjunction with the features that in the first channel a valve insert, which forms a valve with the wall of the first channel, or a valve is arranged wherein the flow resistance of the valve for fluid is in the direction of a pressure gradient when the fluid pressure in a first channel length portion of the first channel between the valve and the connector is greater by a certain amount of differential pressure than in a second channel length portion of the first channel between the valve and the balloon, is less than when the fluid pressure in the first channel length portion is less than this differential pressure amount than in the second channel length portion.

Regarding these two above-mentioned, in each case independent aspects of the present invention, there are numerous possibilities for the preferred development. Thus, it is preferred that the catheter conduit from the valve or valve insert towards the connection means has a first distance slightly spaced on its outer side and a second mark slightly spaced from the valve or valve insert towards the balloon, these being Markers, for example, can act around the circumference of the catheter line circumferential, contrasting with the color of the catheter lead color strip. In a preferred embodiment, the two color stripes have mutually different shades. For example. There may be a black color ring on the proximal side of the valve and a red color ring on the distal side of the valve. Such markings facilitate the preferred handling of the balloon catheter described below. Alternatively or in combination, the catheter line, preferably at least in a longitudinal section extending from the balloon in the proximal direction, that is to say in the direction of the connection device, may have markings spaced apart on the outside, in particular contrasting color rings, for endoscopically moving forwards or backwards and attained reached longitudinal position of the catheter line. In a preferred embodiment of the valve insert, the tube has a circular cross-section. It is also preferred that the through-bore is formed by means of a recess which is bounded by an edge contour of the tube, which runs concavely rounded in a longitudinal sectional view leading through the geometric longitudinal central axis of the tube. There is also the possibility that the balloon-oriented, ie the distal, longitudinal end of the tube is sealed there by means of a bolt inserted in its local end opening, wherein it is preferably provided that the bolt is soldered on the end face of the tube, Adhesive or the like is sealingly attached.

In the context of the invention, it is preferred that the connection device is fixedly connected to the catheter line, for example adhesively bonded, pressed, fused or the like. In this respect, preference is given to a connection which does not permit destruction-free and intended severing of the connection device from the proximal longitudinal end of the catheter line. However, a separation of the connection device from the balloon catheter is destructive, for example by cutting the catheter line, possible.

It is considered appropriate that the line length of the catheter line between the valve and the connection device is smaller, preferably smaller by at least an order of magnitude, than the line length of the catheter line between the valve and the balloon. In a preferred embodiment In the exemplary embodiment, the distance between the connection device and the valve is only a few centimeters (for example 6 to 7 centimeters), while the distance between the valve and the balloon may, for example, be on the order of one to a few meters. For example. For example, the total length of the cath- eter pipe can be about 2.1 meters. The valve or the valve insert are thus located in the vicinity of the proximal longitudinal end of the catheter line. In connection with the preferred use of the balloon catheter described above, this has the advantage that, after disconnecting the connection device and possibly the valve, the predominant length of the catheter line still remains usable.

Concerning the valve formed by the valve core with the wall of the first channel formed by the catheter tube, it is preferred that the catheter lead be at least in a catheter length section in which its wall encloses the passage opening and extends away from the catheter

A passage opening at least to the longitudinal end of the tube, which is oriented towards the balloon, or at least extends to the longitudinal end of the valve core, which is oriented towards the balloon, has elastically deformable material or consists of such material. According to an expedient embodiment, the catheter line may also be preferably made of the same material along its entire length. As a sufficiently elastically deformable material for the production of the catheter line is generally a rubber or plastic-like material into consideration. For example. is suitable polyamide and bismuth composite material. The envelope of the balloon is suitably made of rubber or plastic-like material, for example made of latex.

The aforementioned first connection of the connection device can in turn comprise a valve which can be switched between an open position and a closed position. There is also the possibility that the connection Direction of a second port for supplying another fluid, for example. Of contrast agent, and / or a third port for performing a guidewire or mandrin that the catheter line has in its interior a extending in its longitudinal direction of the second channel, with the second Connection and / or is in open communication with the third terminal of the connection device and which extends to a, preferably frontally, opening at the distal longitudinal end of the catheter line. It is preferably provided that the second hollow channel has a larger hollow cross section, in particular a larger diameter of the hollow cross section, than the first hollow channel.

According to a further aspect, it is preferred that the catheter conduit comprises at least two conduit sections, of which a first conduit section is firmly connected to the attachment device and a second conduit section is fixedly connected to the balloon. A fixed connection means that there are no means for repeated coupling and uncoupling. The so-called first channel extends in the first and in the second line section. The so-called second channel also extends in the first and in the second line section. It is preferably provided that a length of the tube emanating from the frontally open longitudinal section is inserted into the first channel at the longitudinal end of the first line section facing away from the connection device, and that a longitudinal section of the tube extending from the frontally closed longitudinal end also includes the shell side Passage opening contains, is inserted at the side remote from the balloon, ie proximal longitudinal end of the second line section in the first channel. The tube thus simultaneously forms a coupling element between the first and the second line section. With regard to an undeformed catheter line cross section, it is preferred that the inner cross section, in particular the inner diameter, of the first channel is smaller, in particular only slightly smaller, than the outer cross section, in particular as the outer cross section Outer diameter of the tube is. This difference in diameter may preferably be on the order of one hundredth or one thousandth of a millimeter and is preferably chosen so large that the wall of the catheter conduit enclosing the first channel fits so tightly thereon after insertion of the tube after its elastic expansion that a frictional fit is achieved Plug connection results, the axial holding force is not exceeded in normal use of the balloon catheter. The valve insert is therefore not intended for coupling or uncoupling during use. There is the possibility that a tube is inserted into the second hollow channel extending in the catheter line along or parallel to the first channel, wherein a first longitudinal section of the tube in a longitudinal end of the first conduit section and a second longitudinal section of the tube is inserted in a longitudinal end of the second conduit section, wherein with respect to an undeformed catheter line cross section of the inner cross section, in particular the inner diameter of the second channel smaller, especially in the sense of the above-mentioned range slightly smaller than the outer cross-section, in particular as the outer diameter of the tube is. The tube also forms a connecting element for non-positive connection of the first line section and the second line section, which are components of the catheter line. The tube, its bolt and / or the tube may preferably be made of stainless steel. The tube and the tube thus preferably have a higher bending and bending stiffness in comparison to the catheter line and thus also bring about a desired stiffening of the connection of the two line sections. Also, the second channel extends in the first and in the second line section, wherein, according to the continuous hollow channel in the inserted tube, the second channel is also continuous at the connection point and for example. Use of contrast agent and / or a guidewire or Mandrin used can be. With regard to the interface of the two management Part pieces is preferred that the remote from the terminal device, ie distal longitudinal end of the first line section and facing away from the balloon, ie proximal longitudinal end of the second line section are spaced apart only with a thin gap or each other, in particular along the entire circumference, touch and in particular with each other, in particular cohesively, connected, for example, glued together, are.

According to an alternatively preferred embodiment, there is the possibility that the catheter conduit comprises at least a first conduit section, a second conduit section and a third conduit section, wherein the valve insert is inserted into the third conduit section in the first channel, that the valve insert in the longitudinal direction of the third conduit section of spaced apart from both longitudinal ends of the third line section, that the first line section is fixedly connected to the connection device and the second line section fixed to the balloon, that a first connecting tube is provided, each in a longitudinal section in the first channel at a respective Longitudinal end of the first and third line section is inserted, that a second connecting tube is provided, which is inserted in a respective length in the first channel at a respective longitudinal end of the second and the third line section, da ss a first connecting tube is provided which is inserted in each case a longitudinal section in the second channel at a respective longitudinal end of the first and third line section, and in that a second connecting tube is provided, each in a longitudinal section in the second channel at a respective longitudinal end of the second and the third line section is inserted.

Hereinafter, a preferred procedure and a method is presented, on the one hand to further explain the operation of the balloon catheter according to the invention and to explain a preferred procedure for the use of the balloon catheter according to the invention and on the other hand, with regard to an independent claim of the method as a further aspect within the scope of the invention. It is a procedure or method for using a balloon catheter comprising the steps of providing a balloon catheter and delivering fluid into the balloon of the balloon catheter. In particular, the invention is based on the object insofar as advantageous to develop such a method, in particular nutzsvorteilhaft.

In this connection, it is proposed that a balloon catheter be provided, one or more of those described above

Characteristics in that fluid is supplied into the balloon interior through the first port and the first channel, so that the balloon expands due to the increasing internal pressure, and that later the catheter line between the valve and the connecting device, preferably at the first mark, severed, preferably cut, and the connection device is removed from the remaining balloon catheter. Such a procedure is also suitable for non-surgical, non-therapeutic and non-diagnostic procedures. The proposed method according to the invention can nevertheless be used in connection with endoscopic interventions on the human or animal body and, for example, for the introduction of contrast medium into a vessel or hollow organ, for comminution and / or removal of concrements or tissue parts or, for example also for examination measures, even without the conclusive rating of a doctor on the basis of the examination results. It is preferred that the distal longitudinal end of the balloon catheter is inserted into a vessel or a hollow organ of the body and it is expanded to fix the position of the balloon by fluid supply until it is non-positively and / or positively supported against the inner wall of the vessel or the hollow organ. After sufficient fluid supply, the catheter line between the valve and the connection device is severed, so that the pressure in the interior of the first Channel length portion of the first channel can fall under the pressure inside the second channel length portion of the first channel. Depending on the configuration of the valve insert, the valve which it forms with the catheter line is either dense or allows the fluid to escape only slowly from the second channel length section into the first channel length section of the first channel, and it is sufficient for many applications when the balloon for a period of about four to five minutes in a body cavity due to its expansion fix. There are numerous possibilities for the preferred development of the method or procedure. Thus, it is preferred that, before the balloon is expanded by fluid delivery, the balloon catheter be advanced with the balloon, particularly along a guidewire or stylet, through the working channel of a first endoscope until the balloon is outside the distal longitudinal end of the working channel the connection device is located outside the working channel at its proximal side. Preference is given to a connection device with a plurality of terminals, which can not be passed through a working channel usual cross section due to their dimensions. It is conceivable that the balloon catheter may be inserted in the endoscope before or after insertion of the endoscope into a body.

Working channel is introduced. There is also the possibility that the balloon catheter is advanced to the desired position along a guidewire or stylet extending through its second channel in the body. There is the possibility that the first endoscope after cutting the catheter line in the direction of the inflated balloon away, ie in the proximal direction, completely withdrawn from the catheter line. Unintentional entrainment of the balloon catheter can be prevented by the expanded balloon, which is thus still fixed in its position in the vessel or hollow organ. There is also the possibility that after removal of the first endoscope, a second endoscope, which has a different design and which preferably has a smaller outer diameter than the first endoscope, is pushed so far with its working channel on the catheter line connected to the balloon in the distal direction, that the Balloon is still located outside the working channel. In this case, the catheter line can serve as a guide for the second endoscope, that is, as a tool for instrument replacement in the body. The method or the method of use can be further developed in that, after the second endoscope has been pushed onto the catheter line, the valve is separated from the catheter line connected to the balloon, preferably at the second marking, in particular by cutting the catheter line, so that the Fluid now also quickly escapes from the second channel length portion of the first channel and the balloon contracts. Subsequently, the balloon and the associated catheter line can be pulled out in the proximal direction from the working channel of the second endoscope. In view of the here proposed severing of the catheter line, wherein no means for reconnection are present at the separation point, is to speak of a disposable balloon catheter. The method or procedure is suitable for a variety of measures on hollow organs or vessels.

There is the possibility that the balloon catheter according to the invention preferably comprises, as an accessory, a filling device which, after the valve has been separated from the catheter line connected to the balloon, makes it possible to refill the balloon. The filling device expediently comprises a hollow needle and a housing sealingly connected thereto. At least one connection for the supply of fluid, preferably for the detachable attachment of a syringe or a fluid line or the like, is preferably formed on the filling device. A fluid passageway extending in the housing is in fluid communication with the connection and with the hollow needle. Preferably, ie not necessarily, a shut-off valve (eg stopcock) is inserted into the housing, by means of which the fluid passage can be selectively opened or sealed. As the fluid is preferably air into consideration. It is preferred that the outer diameter of the hollow needle is selected to be slightly larger than the inner diameter of the first channel of the catheter line. The term fluid passage is understood in a broad sense. For example. it may be a hollow interior of said housing with a variable in the flow direction of the fluid cross-section or, for example, to a conduit-like fluid passage having a substantially constant cross-section. In view of the purpose of use explained below, the filling device can also be referred to as a refilling device or refilling needle. Preferably, the outer diameter of the hollow needle is selected to be several tenths or hundredths of a millimeter larger than the inner diameter of the first channel, so that the hollow needle after separating the valve from the further connected to the balloon length of the catheter line at the proximal longitudinal end formed at the separation this length section can be inserted into the first channel of the catheter line while applying a certain longitudinal force and achieving a sealing plug-and-socket connection. By virtue of the catheter conduit comprising or consisting of elastically deformable material, it is possible to achieve a sealing plug-in connection which effectively seals against fluid or air pressures which occur when the balloon is inflated when it is used as intended. The filling device can comprise a stylet, which can either pass through the port, through the fluid passage in the housing and through the hollow needle or can be removed from the filling device. In the course of a preferred application of the balloon catheter, there is the possibility that the catheter line between the valve and the balloon cut through, preferably cut, has been and that the filling device is inserted at its hollow needle at the proximal longitudinal end of the then connected to the balloon length portion of the catheter line in the first channel while achieving a plug-terminal connection. If a fluid supply device, for example a syringe, is connected to the connection 77 and the shut-off valve is brought into the open position, the balloon can be supplied by means of supply of fluid, preferably air, through the filling device into the catheter line, for example for renewed dilatation. inflated with air or inflated to an approximately spherical shape.

In connection therewith, the invention also relates to a balloon catheter, which can be formed after disconnecting the valve by means of connecting the filling device to the length of the catheter line still connected to the balloon. This is a balloon catheter comprising a catheter conduit, an expandable balloon surrounding a balloon interior and formed on the catheter conduit, and comprising balloon filling means, the catheter conduit having a proximal longitudinal end, from which it extends in its longitudinal direction to its distal longitudinal end on which or to which the balloon is adjacent, at least one first channel, which is in fluid communication with the balloon interior, extending in the catheter tube in its longitudinal direction. In this context, it is further provided that the first channel opens at the proximal longitudinal end of the catheter line into an opening, that the filling device comprises a hollow needle and a subsequent housing, that the filling device at least one connection for supplying fluid, preferably a connection to the detachable Fastening a syringe or a fluid line or the like to the housing, has a fluid passage extending in the housing, which is optionally closable or open by means of a shut-off valve of the filling device, in fluidic manner. bond with the terminal and with the hollow needle is, and that the outer cross section, preferably the outer diameter of the hollow needle is slightly larger than the inner cross section, preferably selected as the inner diameter of the first channel of the catheter line. This allows the hollow needle to be inserted through the opening at the proximal longitudinal end of the catheter conduit into the first channel to provide a sealing male-female connection.

Also, the method according to the invention described and specified in the claims can be further developed using the explained filling device, to which reference is also made to the detailed description of the figures, so that corresponding features can also be the subject of method claims. The invention and its preferred application will be further described below with reference to the accompanying figures, which indicate preferred embodiments. 1 shows a balloon catheter according to the invention according to a first preferred embodiment in a side view shortened by a departure, before the start of the fluid supply;

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

FIG. 1b shows detail 1b of FIG. 1 in a sectioned enlargement of the balloon catheter of 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. 3 shows the valve insert shown in FIG. 1a, on the other hand enlarged in a partially sectioned longitudinal view;

3a shows a plan view of the valve insert in the direction of view purple from FIG. 3; FIG. 3b shows a sectional view of the valve insert along sectional plane IIIb-IIIb in FIG. 3; FIG.

FIG. 3c shows the valve insert shown in FIG. 3 before assembling the individual parts; FIG.

Fig. 4 detail IV of Figure 1 in an enlarged sectional view.

FIG. 5 shows the arrangement shown in FIG. 4, but in a use state according to FIG. 5; FIG.

FIG. 6 shows the arrangement shown in FIG. 5, but after a further change in the pressure conditions;

7 shows a cross section along the sectional plane VII - VII in FIG. 4, in contrast, in magnification;

7a shows a cross section along the sectional plane VIIa - VIIa in FIG. 4, in contrast, in magnification; FIG. 8 shows the balloon catheter shown in FIG. 1, but with the guidewire passed through; FIG.

FIG. 9 shows the arrangement shown in FIG. 8, wherein the catheter line is additionally guided through the working channel of an endoscope; FIG.

Fig. 10, the arrangement shown in Fig. 9, but after removing the

Guidewire, wherein the distal longitudinal end is in a body cavity,

Fig. 11, the arrangement shown in Fig. 10, but after the inflation of the

balloons;

Fig. 12, the arrangement shown in Fig. 11, but after the separation of

Connecting device;

Fig. 12a detail Xlla of Figure 12 in a sectional view and in contrast enlarged. Fig. 13 shows the situation after the first endoscope has been withdrawn from the catheter line, starting from the situation shown in Fig. 12;

14 shows a situation after a slimmer endoscope has been pushed onto the catheter line starting from the situation shown in FIG. 13;

15 shows a situation in which, starting from the situation shown in FIG. 14, the valve has been separated from the catheter line, FIG. 16 shows a situation in which, starting from the situation shown in FIG. 15, the balloon catheter has been pulled out of the second endoscope in the proximal direction, FIG. 17 shows a balloon catheter according to a second preferred embodiment in a side view shortened by a departure, FIG. before starting the fluid supply,

18 shows detail XVIII from FIG. 17 in a sectioned enlargement shortened by two fractures, FIG.

19 shows the balloon catheter shown in FIGS. 17 and 18, but with inflated balloon, with a first endoscope, already after the later disconnection of the connection device,

FIG. 20 shows a position of use after the first endoscope has been withdrawn from the catheter line and removed, starting from the situation presented in FIG. 19. FIG , slimmer endoscope was postponed,

22 shows a use position in which, starting from the situation shown in FIG. 21, the valve has been separated from the catheter line, FIG.

Fig. 23 in a view a filling device with inserted therein

Stylet, according to a preferred embodiment, for use with a balloon catheter according to the invention, FIG. 24 shows in a longitudinal section the filling device with inserted stylet shown in FIG. 23, in a longitudinal section the filling device according to FIGS. 23, 24, wherein the stylet has been removed and a syringe has been connected for fluid supply, in comparison with FIG the proximal longitudinal end of the still connected to the balloon catheter line formed before the connection of the filling device, starting from the situation shown in Fig. 26 the state of use after the connection of the filling device, while the balloon is still contracted and

Fig. 28 shows the arrangement shown in Fig. 27, but after refilling the balloon.

With reference to FIGS. 1 to 7, a balloon catheter 1 according to the invention is presented according to a first preferred embodiment. This comprises a catheter line 2, an expandable balloon 3, which borders a balloon interior 4 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. The second connection 8 serves to supply another fluid, for example of contrast agent, and the third connection 9 serves to carry out a later-acting operation. ren figures illustrated guidewire or mandrin. 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 port 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 open together in 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 out of the channel 11 into the balloon interior 4 leading through hole 42, the channel 11 is in its longitudinal section between the valve core 13 and the distal longitudinal end of the channel 11, which Figure lb shows, 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 also shows that in the first channel 11, a valve insert 13 is inserted, which is formed in the example of a tube 14 and a plugged therein and soldered bolt 15.

As is also clear in connection with FIGS. 3 to 3c, the tube 14 in its mounting state shown in FIGS. 1, la is open on its end face 16 oriented towards the connection device 6, that is to say in the proximal direction, and on its opposite, so to the balloon 3 oriented towards and thus pointing in the distal direction longitudinal end by means of the bolt 15 frontally closed.

In the tube 14 extends in the longitudinal direction L, a channel 19, in which extending from the distal longitudinal end 17 longitudinal portion a of

Bolt 15 is inserted. In the longitudinal section which is inserted into the channel 19, the diameter of the bolt 15 corresponds to the diameter of the channel 19. In order to limit the insertion depth to the longitudinal section a, the bolt 15 expands on an annular shoulder 21, which positively engages against the front side of the channel during insertion Tube 14 occurs. In the remaining length section b of the tube 14 is located in the channel 19, a cavity 20. This extends along the longitudinal direction L in the direction of the connecting device 6 to a frontal opening 22 of the tube 14 and in the distal direction, ie in the direction of the Balloon 3, up to the front-side closure 24, which is formed by the bolt 15 and the bolt end face 23 thereof. In generalization of this embodiment, any closure which fills the cross-section of the channel 19 in a projection view guided along the longitudinal direction L is suitable, i. H. it is not necessary for the closure to form an end face perpendicular to the longitudinal direction L. In the example, the tube 14 in its initial state has a cylindrical, in cross-section circular tube wall, which is referred to as the jacket wall 25. This is a transversely through the jacket wall 25 leading and opening into the cavity 20 through opening 26 is formed, which is in fluid communication with the frontal opening 22 by means of the cavity 20. The passage opening 26 can also be used as the shell-side opening of the

Tube 14 or be referred to as a valve opening. In the protruding from the tube 14 length section c of the bolt 15 whose diameter is slightly smaller than the outer diameter of the tube 14th As FIGS. 4 to 6 show schematically, the valve insert 13 cooperates with the wall 27 of the catheter line 2 surrounding the first channel 11 in cross-section as a valve 28. In these illustrations, a distinction is made in length between two channel length sections 31 and 32 of the first channel 11. The first channel length section 31 extends in the longitudinal direction of the catheter line 2 between the valve insert 13 and the connection device 6 and establishes a fluidic connection, ie a connection suitable for the passage of fluid, between the valve insert 13 and the connection device 6. The second channel length section 32 extends in the longitudinal direction of the catheter line 2 from the valve core 13 or the tube 14 to an opening 42 connecting the first channel 11 laterally to the balloon interior 4 and in the example still a short distance beyond the opening 42 to to the distal longitudinal end of the first channel 11. In the second channel length section 32, the first channel 11 establishes a fluidic connection between the valve core 13 and the balloon interior 4. The valve insert or the valve is thus located between the first and the second channel length section. Thus, when the valve 28 is opened, the connector 6 is in 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. 4 shows the initial situation also 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.

In the undeformed initial state of the catheter line 2, the clear cross section of the first channel 11 is slightly smaller than the cross section determined by the outer diameter of the tube 14, so that the channel 11 was somewhat widened in cross section when the valve insert 13 was inserted and the elastic Table deformable wall 27 of the catheter line, the tube 14 therefore frictionally encloses on its outer side. In the state of use shown in FIG. 4, the wall 27 also bears sealingly against the tube 14 along the entire edge of the passage opening 26. Thus, the passage opening 26 serving as a valve opening is closed by the wall 27, and the corresponding valve 28 formed by the valve insert 13 with the wall 27 of the catheter line 2 valve 28 is in the closed position, in which no or at most very slow exchange of fluid between the first Channel length portion 31 and the second channel length portion 32 is possible.

FIG. 5 shows the valve 28 in the use state corresponding to FIG. Fluid was supplied into the first channel length portion 31 by means of the syringe 18, so that the pressure Pi acting there and consequently in the cavity 20 of the valve seat 13 is greater than the pressure P ₂ in the second channel length portion. The direction of the pressure gradient 33 is indicated by an arrow. In the region of the shell-side through opening 26, the fluid presses against the wall 27, whereby it is radially expanded. It forms an outgoing from the edge of the passage opening 26, permeable to the fluid conduction path 34 formed between the shell wall 25 and the wall 27 in the longitudinal direction L of the tube 14 to the formed between the bolt 15 and the wall 27 in the longitudinal section c Gap 35 is enough. As a result, the valve 28 is in an open position in which it is permeable to fluid in the direction of the pressure gradient 33. In FIG. 5, arrows 36 indicate the flow path along which fluid can flow out of the first channel length section 31 into the second channel length section 32 in order to inflate the balloon 3 with fluid. When the valve 28 is open, consequently, the first connection 7 is in fluid communication with the balloon interior 4 by means of the first channel 11. FIG. 6 shows the valve 28 in a still further state of use which, in a preferred application, follows the state of use shown in FIG. This can be achieved after the supply of fluid has been terminated and, in particular, even when the catheter line 2 has been severed between the valve 28 and the connection device 6. The pressure P ₂ acting in the second channel length section 31 is greater than or equal to the pressure Pi acting in the first channel length section 31 and in the cavity 20, so that either no pressure gradient or the pressure gradient now acting in the direction of the arrow 33 exists. The pressure Pi has dropped so far that the wall 27 has elastically deformed back into its previous or original shape elastically and now bears again sealingly along the edge of the passage opening 26 on the outside of the tube 14. The valve 28 is again in the closed position. The pressure P ₂ can now be comparatively greater than the pressure Pi. For example, the pressure P _{2 may be} as large as before the pressure Pi during the fluid supply. For example, in FIG. 6, the pressure Pi may again correspond to the ambient pressure Po. Despite the comparatively high pressure P ₂ , in the valve position shown in FIG. 6, no fluid flows or, depending on the specific embodiment, only a considerably smaller volume flow of fluid through the valve 28 than in FIG. 5. This is because that under pressure P ₂ standing fluid in the second channel length portion 32 in the now narrow gap 35, which tapers at its proximal longitudinal end according to a formed from solder ring groove 37 even further, no suitable or no sufficient attack surface is to radially expand the wall 27. Depending on the particular configuration or geometry chosen for the specific individual case and depending on the effective pressures, the valve 28 can either be completely or almost completely closed. It is clear from the example described that the flow resistance of the valve 28 in FIG. 5 is lower than when the pressure conditions according to FIG. 6 are reversed. As FIGS. 4 to 6 also show, in the example chosen, the through-opening 26 is formed in the jacket wall 25 of the tube 14 by means of a domed recess 38. The curvature runs in or parallel to the plane of the drawing of FIG. 3, so that the geometric normal of the plane in which the curvature extends runs perpendicular to the geometric longitudinal axis X of the tube 14.

FIG. 7 a shows that the wall 27 of the first channel 11 has only a comparatively small wall thickness, which in the example is 0.1 millimeter, on the cross-sectional side facing away from the second channel 12. In the example, but not necessarily, has in the cross section, the passage opening 26 in the direction away from the second channel 12 direction. For example, as shown in FIGS. 1 and 2, in the exemplary embodiment it is provided that the catheter line 2 is only slightly spaced from the valve 28 in the direction of the connection device 6 on its outside a first marking 39 and from the valve 28 in the direction of the balloon 3 also only slightly spaced a second mark 40 has. The first marker 39 is a black color ring and the second marker 40 is a red color ring. In the area of a sleeve-like kink protection 41, the catheter line 2 is connected in a manner not shown fixedly to the connection device 6. In FIGS. 1 and 2, the catheter line 2, which extends from its distal longitudinal end 5 to the connecting device 6, is shown shortened by means of an opening 29 selected for purposes of illustration. In the example, the total length of the catheter conduit 2 is about two meters, while the distance from the valve 28 to the connection device is only a few centimeters, that is, at least an order of magnitude smaller. FIGS. 1 and 2, in conjunction with the sectional FIGS. 1b and 2b, show that, in the catheter line 2, the first channel 11, which is in fluid communication with the first connection 7, does not reach all the way to the distal longitudinal end 5, However, with its longitudinal end there 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 line 2 extends from the connecting device 6 to a front opening 45 formed at the distal longitudinal end 5.

In the example, the catheter conduit 2, which extends from the connection device 6 to the distal longitudinal end 5, comprises two conduit sections 46, 47, which are arranged one behind the other in the longitudinal direction or connected to each other with one longitudinal end. The first line section 46 is fixedly connected to the connection device 6 and the second line section 47 fixed to the balloon. A longitudinal section e of the tube 14, which starts from its proximal longitudinal end 16, is at the longitudinal end 48 of the first line section 46 facing away from the connecting device 6 into the first channel 11 inserted, cf. FIG. 4. The longitudinal section f of the tube 14 which extends from the distal longitudinal end 17 of the tube 14 and remains in length in the example is inserted into the first channel 11 at the longitudinal end 49 of the second line section 47 facing away from the balloon 3. The tube 14 thus also forms a connection coupling to the fixed plug-in connection of the two line sections 46, 47. As a further, the connection stabilizing connector coupling is a second tube 50, which is inserted into the second channel 12. A first longitudinal section g of the tube 50 is inserted into the first conduit section 46 and a second longitudinal section h of the tube 50 into the second conduit section 47, wherein also the second channel

12 was slightly widened, so that a positive connection results. In the example shown, the line sections 46 and 47 are pushed onto the tube 14 and onto the tube 50 so far that their longitudinal ends 48 and 49 touch at the end faces. The frontal gap can, if necessary, by means of separate measures, eg. By means of hot air treatment,

Sealant or the like sealed. The first line section 46 is integrally formed, d. H. has no coupling agents with which it could be disassembled nondestructively in part lengths and reassembled. The first port 7 comprises a valve 52. In the example, the catheter conduit 2 is made of composite material containing polyamide and bismuth. The through hole 26 is formed on the tube 14 with respect to the longitudinal direction L approximately centrally.

With reference to Figs. 8-16, various preferred conditions of use of the balloon catheter 1 shown in Figs. 1-7 are shown during preferred applications, and particularly during preferred methods of using it in accordance with the present invention. In the state of use shown in FIG. 8, a guide wire 53 is passed through the third connection 9 and the associated second channel 12, with its proximal longitudinal end 54 coming out of the connection 9 in the proximal direction protrudes and its distal longitudinal end 55 protrudes in the distal direction from the end opening 45. FIG. 8 also shows that, in the longitudinal section adjoining its distal longitudinal end 5, the catheter tube 2 on the one hand has equally spaced, mutually uniform line markings 56 which can be used for endoscopic monitoring of longitudinal movements of the balloon catheter 1. On the other hand, line markings 57 are also provided, which differ in their number of strokes from one another and which can serve for the endoscopic determination of the achieved longitudinal position of the balloon catheter 1 or its feed depth.

FIG. 9 shows a use state in which the balloon catheter 1 with its distal longitudinal end 5 has been pushed forwards through a working channel 58 of a first endoscope 59. As with the other figures, here as well, by means of the opening 29, a representation shortened in the longitudinal direction is selected. The balloon 3 projects beyond the distal longitudinal end 60 of the endoscope. To obtain this state of use, for example, the endoscope 59 can first be introduced into a vessel or a hollow organ in a body. For example. Then, the guide wire 53 is passed through the working channel 58 and finally the balloon catheter 2 along the guide wire 53 through the working channel 58 tracked. This order can also be reversed, or the balloon catheter 1 is guided into the working channel 58 with guide wire 53 already passed through it. FIG. 10 shows a state of use in which, starting from FIG. 9, the guide wire 53 has been pulled out of the connection 9 in the proximal direction. The endoscope 59 may have at its distal longitudinal end 60 frontally or laterally an optic 61. As a result, it can be observed that the balloon 3, during advancement, in particular along a guide wire 53, reaches a desired position in a body cavity designated 62 (for example in a vessel or in a hollow organ). Figure 11 shows a subsequent use condition in which the balloon 3 has been inflated in the manner already described with reference to Figures 1-7 until it is firmly seated between the body cavity walls 63 to obstruct or prevent inadvertent longitudinal displacement. The position of the enclosed by the catheter line 2 and therefore hidden valve insert is shown by the dashed line reference to numeral 13. FIG. 11 illustrates that, due to the comparatively large dimensions of the connection device 6, the endoscope 59 can not now be removed from the balloon catheter 2 backwards, ie in the proximal direction. In order nevertheless to be able to remove the endoscope 59 or exchange it for another endoscopic instrument, it is provided that the catheter line 2 is severed between the valve 28 and the connection device 6, preferably at the first marking 39 shown. This can be done, for example, by cutting the catheter line 2, ie its tube, with a pair of scissors or with a knife. As FIG. 12 shows, the connecting device 6 can then be removed from the remaining balloon catheter 1 and, as a result, as a result, FIG. 13, the endoscope 59 can be withdrawn from the balloon catheter 2 in the proximal direction. After cutting off the connection device 6 at the marking 39, the balloon 3 still remains inflated, since the valve 28 remains closed in the manner previously described with reference to FIGS. 1 to 7.

FIG. 14 shows that, starting from the use state achieved in FIG. 13, for example, a second endoscope 64, which, for example, may have a smaller outside diameter than the first endoscope 59, shown dashed for comparison, with its working channel to the balloon 3 towards, ie in the distal direction, can be pushed onto the serving as a guide catheter tube 2. FIG. 15 shows, as a subsequent use state, that after pushing the second endoscope 64 onto the catheter line 2, the valve 28 has been cut off from the catheter line 2 connected to the balloon 3 at the second marking 40, so that the fluid escapes from the proximal longitudinal end and the balloon 3 contracts. As FIG. 16 shows, the catheter line 2 connected to the balloon 3 can now be pulled out of the second endoscope 64 in the proximal direction.

It will be understood from the foregoing description that the balloon 3 is inflated between the body cavity walls 63 in the use shown in the figures until the valve 28 is cut off, or as long as the balloon 3 is inflated and expanded as shown in FIGS. 11 to 14 remains clamped and thus remains unchanged during the endoscope exchange in the position shown in Figure 11, even if in Figures 12 to 15, the body cavity walls 63 are not shown for simplicity and the

Catheter course schematically simplified slightly different from Figure 11 is shown. Only a contraction of the balloon 3 eliminates the holding effect, so that the positional fixation is canceled and the balloon 3 between the body cavity walls 63 out and can be withdrawn through the endoscope 64 therethrough. In FIGS. 14 to 16, the first endoscope 59, which is not present in the local states of use, is indicated by dashed lines only for a qualitative comparison of the diameters and therefore in the same length range as the second endoscope 64. It is also understood that there are numerous possibilities for modifying and supplementing the method or the described method of use. For example, the endoscopes used may each have an additional working channel through which, for example, with the aid of suitable endoscopic aids, contrast medium can be injected into the body cavity, tissue samples taken or comparable measures taken. With reference to Figures 17 and 18, a balloon catheter 1 according to the invention is shown according to a second preferred embodiment. There, the catheter line 2 comprises three line sections 65, 66 and 67, which together result in the total length of the catheter line 2. The line sections also have the un-deformed state shown in Figure 7 cross-section. As with the conduit sections 46 and 47 of the first embodiment, I am to be flexibly bent catheter tube pieces of elastically deformable material. Preferably again comes composite material containing polyamide and bismuth, into consideration. The first line section 65 is fixedly connected to the connection device 6. The second line section 67 is fixedly connected to the balloon 3. The third line section 66 is set between the two line sections 65 and 67. The first channel 11 and the second channel 12 extend through all three line sections. The valve insert 13 corresponds to the valve insert described with reference to FIGS. 1 to 7. In the second exemplary embodiment now shown, the valve insert 13 is inserted into the third conduit piece 66 in the first channel 11 such that the valve member 13 is spaced apart in the longitudinal direction of the third conduit portion 66 from its two longitudinal ends 68, 69. A first connecting tube 70 is inserted at a respective longitudinal section in the first channel 11 at a respective longitudinal end of the first and the third line section 65, 66. A second connecting tube 71 is inserted at a respective length in the first channel 11 at a respective longitudinal end of the second and the third line section 67, 66. A first connecting tube 72 is inserted at a respective longitudinal section in the second channel 12 at a respective longitudinal end of the first and the third conduit section 65, 66, and a second connecting tube 73 is at a respective longitudinal section in the second channel 12 at a respective longitudinal end of the second and third line sections 67, 66 inserted. Also in this embodiment, the connectors between the line sections during use do not serve for their coupling or uncoupling. Instead, they are also in the second embodiment shown in Figures 17 and 18 again Markings 39, 40 are provided which mark 2 preferred positions for cutting, in particular for cutting, the catheter line. Incidentally, the same reference numerals have been used for features that correspond to features of the first embodiment to the overview. The operation is the same as in the described first embodiment. With regard to all matching features, advantages and possible embodiments, reference is made to the preceding description. With reference to FIGS. 19 to 22 and 26 to 28, a preferred application example or a preferred method for the use of the balloon catheter 1 shown in FIGS. 17, 18 is presented. The filling device 74 also used is shown in more detail in FIGS. 23 to 25, wherein the filling device 74 can also be used, for example, in conjunction with the balloon catheter 1 illustrated in FIGS.

FIG. 19 shows the balloon catheter 1 already described with reference to FIGS. 17, 18 in a state of use analogous to FIG. 12, in which the balloon 3, whose construction corresponds to that of the balloon of the first exemplary embodiment, is kept pumped between body cavity walls 3 with air after the connection device 6 has been disconnected after inflation. In this respect, with regard to the preceding method steps, such as, for example, passing the balloon catheter 1 through a first endoscope 59, advancing the balloon 3 into a body cavity 22 (for example into a hollow organ) bounded by body cavity walls 23 and expanding the balloon 3 Positional fixation in the body cavity 62 to the description to previous figures be taken. In addition, the body cavity walls 63 are also shown in FIG. 19. The mark 39, which is a first preferred separation point of the catheter line 2 on the Proximal side of the valve 28 is located outside of the endoscope 59 on its proximal side. After severing the catheter line 2 at the first marking 39, the connection device 6 is removed. The valve insert 13 or the valve 28 is still in its closed position on the catheter line 2 firmly connected to the balloon 3, so that the balloon 3 is filled with air and therefore remains expanded and thus also the positional fixation of the balloon 3 in FIG the body cavity 62 continues to exist. After disconnection of the connection device 6, the first endoscope 59 can be withdrawn in the proximal direction, that is to say backwards, from the catheter line 2 connected to the balloon 3. By means of the further expanded balloon 3 or the positional fixation can be achieved thereby, that upon retraction of the endoscope 59, the catheter line is not dragged, ie the balloon 3 remains at the same position. This situation is shown in FIG.

FIG. 21 shows a subsequent use state in which a second, slimmer endoscope 64 has been pushed in the distal direction, that is to say in the forward direction, onto the catheter line 2 connected to the balloon 3. The second endoscope 64 has a smaller diameter than the now no longer existing, shown in dashed lines in Figure 21 for comparison purposes first endoscope 59. Depending on the application, this advantageously allows the thinner endoscope 64 in the direction of the balloon 3 as the comparatively thicker endoscope 59 can advance (as this is only indicated schematically or qualitatively in Figure 21). In Figure 21, the endoscope 64 is advanced so far that a second mark 40 is exposed. This marks a preferred position of the catheter conduit 2 for a subsequent preferential separation of the valve 28 from the catheter conduit 2 connected to the balloon 3. Figure 22 shows that the separation of the valve 28 causes the rapid contraction of the balloon 3 still in the body cavity 62, so that its positional fixation between the body cavity walls 63 is now canceled. The balloon catheter 1 can therefore be withdrawn in the proximal direction (either with or without the endoscope 64). 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 immediately at the still unchanged position between the body cavity walls 23. 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 in view of this preferred function can also be referred to as a refilling device, will first be described with reference to FIGS. 23 to 25, 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 facing 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 on both sides of the check valve 79 (ie, before and behind) located portions of the fluid passage 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 selectively for the passage of fluid from the syringe 18 apparently closed or to prevent fluid passage. bar. 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 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. 23, 24, 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 projects with its distal longitudinal end 84 over the tip of the hollow needle 75. In Figure 25, the stylet 81 is removed from the filling device 74 and a syringe 18 sealingly connected to the terminal 77. FIGS. 26 to 28 show, by way of example, how the described filling device 74 can be used for refilling or expanding the balloon 3. For this purpose, FIG. 26 shows the proximal longitudinal end 86 of a longitudinal section 85 of the catheter line 2 which is still firmly connected to the balloon 3 and which has been formed in the region of the marking 40 during the separation of the valve 28 or a length section of the cathodic line 2 containing the valve insert 13. There, the first channel 11 and the second channel 12 are free frontally. FIG. 26 shows that the filling device 74 with the stylet 81 inserted therein is inserted into the first channel 11 in the direction of movement of the arrow 87 at the proximal end 86. 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 71 is inserted with the application of a certain longitudinal force in the first channel 11, which according to the described

Diameter ratios is somewhat elastically expanded, so that he finally surrounds the hollow needle 75 while achieving a plug-in connection connection 88. FIG. 27 shows that after inserting the hollow needle 75 into the the first channel 11 of the stylet 81 removed and a syringe 18 can be connected to the terminal 77. FIG. 27 shows this state of use, wherein there is still air (fluid) inside the syringe, the shut-off valve 79 is brought into its open position and the balloon 3 is still contracting, ie with outer diameter substantially corresponding to the catheter line 2, between the body cavity walls 63 of a Body cavity 62 (for example, a hollow organ) is located. FIG. 28 shows a subsequent use state in which the air from the syringe 18 has 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 on the body cavity walls 63 is achieved. In order to obtain this state (also with the possibility of removing the syringe 18), the shut-off valve 79 can, as shown in FIG. 28, be turned into its closed position. In order to be able to vent or contract the balloon 3 again so that it can be removed from the body cavity 62, there is the possibility that the hollow needle 75 is pulled out of the catheter line 2 or the shut-off valve 79, in particular with the syringe 18 removed, again is twisted into its open position. The balloon 3 is also attached to the catheter tube 2 in this example 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 28) is not shown in the figures of the portion of the catheter line 2 passing through the balloon 3, although the balloon envelope can also be made, for example, of a translucent material.

The balloon catheter 1 'thus formed during use, shown in FIGS. 27, 28, comprises a catheter conduit 2, an expansible balloon 3, which borders a balloon interior 4 and is formed on the catheter conduit 2, and a filling device 74 for the bay Ion 3. The catheter lead 2 has a proximal longitudinal end 86 from which it extends in its longitudinal direction to its distal longitudinal end 5, on or adjacent to which the balloon 3 is formed. In the catheter line 2 extends in its longitudinal direction of the first channel 11 which is fluidly connected to the balloon interior 4. At the proximal longitudinal end 86 of the catheter line 2, the first channel 11 opens into an end opening. Through this, the hollow needle 75 is inserted in a certain length section in the first channel 11 of the catheter line 2 while achieving a plug-clamp connection 88.

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 in their optionally sibling version independent inventive developments of the prior art, in particular to make on the basis of these claims divisional applications.

Claims

A balloon catheter (1) comprising a catheter tube (2), an expandable balloon (3) bounding a balloon interior (4) and formed on the catheter tube (2), and a connector (6) at least a first connection (7) for the supply of fluid and which is arranged on the catheter line (2), wherein extending in the catheter line (2) extending in its longitudinal direction at least one first channel (11) at least at its one longitudinal end, in particular at least in a channel length section (31) adjoining the connection device (6) at this longitudinal end, is in fluidic connection with the first connection (7) and at least in another channel length section (32) extending in particular to the other longitudinal end of the channel first channel (11), is in fluid communication with the balloon interior (4), characterized in that in the first channel (11) a valve insert (13) is inserted, which is a Rö a cavity (20) which is present in the tube (14) in a channel (19) running in its longitudinal direction (L), extends in the direction of the connection device (6) up to at least one end-side Opening (22) of the tube (14) and extending in the direction of the balloon (3) to a closure (24) of the channel (19), and wherein at least one transverse through the jacket wall (25) of the tube (14) leading, in the cavity (20) in the tube (14) opening through opening (26) is formed, which by means of the cavity (20) in the tube (14) in fluid communication with the frontal opening (22).

2. Balloon catheter (1), comprising a catheter line (2), an expandable balloon (3), which bounds a balloon interior (4) and which is formed on the catheter line (2), and a connection device (6) the at least one first connection (7) for the supply of fluid and which is arranged on the catheter line (2), wherein in the catheter line (2) in its longitudinal direction extending at least a first channel (11) extending in at least one channel length portion (31) to the first port (7) and in at least one other channel length portion (32) in fluid communication with the balloon interior (4), characterized in that in the first channel (11) a valve insert (13) forming with the surrounding wall of the first channel (11) a valve (28), or a valve is arranged, wherein the flow resistance of the valve for fluid when the fluid pressure in the one 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 other channel length section (32) of the first channel (11) between the valve (28) and the balloon inner space (4) is less than when the fluid pressure in the one channel length portion (31) is smaller by this differential pressure amount than in the other channel length portion (32).

3. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the catheter line (2) of the valve (28) or valve insert (13) in the direction of the connection device (6) spaced on its outer side a first marking (39) and spaced apart from the valve (28) or valve insert (13) in the direction of the balloon (3) has a second marking (40), wherein the two markings (39, 40) are in particular circumferential, to the color of the catheter line (2) contrasting color stripes, wherein the color strips in particular have mutually different shades.

4. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the tube (14) has a circular cross section, wherein it is provided in particular that the through hole (26) by means of a recess (30) is formed in a plane defined by the longitudinal geometric axis (X) of the tube (14) leading longitudinal sectional view of a concave edge contour of the tube (14) is bounded.

5. Balloon catheter (1) according to one or more of the preceding claims or in particular, characterized in that in the channel (19) of the tube (14) in a longitudinal section (a) in the longitudinal direction (L) of the tube ( 14) between the through-bore (26) and the balloon (3), for closing its cross-section, a bolt (15) is inserted, in particular along the pin circumference a separate seal is formed, in particular by the bolt (15) on the at this Long end (17) located end side of the tube (14) by means of solder, adhesive, sealant or the like to the tube (14) is attached.

6. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the connection device (6) with the catheter line (2) firmly connected, in particular glued, pressed, fused or the like.

7. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the line length of the catheter line (2) between the valve (28) and the connection device (6) is smaller, in particular by at least an order of magnitude less , as the length of the catheter line (2) is between the valve (28) and the balloon (3).

8. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the catheter line (2) at least in a catheter length section (d), in which it the middle-side passage opening (26) of the tube (14). encloses and from the passage opening (26) at least up to the longitudinal end of the tube chens (14) oriented towards the balloon (3), or at least extending to the longitudinal end of the valve core (13) oriented towards the balloon (3), comprising elastically deformable material.

9. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the first connection (7) comprises a valve (52) which is convertible between an open position and a closed position.

10. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the connection device (6) has a second connection (8) for supplying fluid and a third connection (9) for guiding a guide wire the catheter line (2) has in its interior a second channel (12) extending in its longitudinal direction, which is in open connection with the second connection (8) and with the third connection (9) of the connection device (6); extends up to a, in particular end-side, opening (45) at the distal longitudinal end (5) of the catheter line (2), wherein it is provided in particular that the second channel (12) has a larger cross section, in particular a larger diameter than the first channel (11).

11. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the catheter line (2) comprises at least two line sections (46, 47), of which a first line section (46) fixed to the connection device (6 ) and a second conduit section (47) fixedly connected to the balloon (3), that a longitudinal portion (e) of the tube (14) extending from the longitudinal end (16) with the frontal opening (22) of the cavity (20) in which the longitudinal end (48) of the first part of the line piece (46) remote from the connection device (6) is inserted into the first channel (11) and one of which front end of the longitudinal end portion (f) of the tube (14), in which the passage opening (26) through the jacket wall (25), on the side facing away from the balloon (3) longitudinal end (49) of the second line section (47) in the first channel (11) is inserted.

12. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that with respect to an undeformed catheter line cross section of the inner cross section, in particular the inner diameter of the first channel (11) smaller, in particular slightly smaller than the outer cross section, especially as the outer diameter of the tube (14).

13. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that in the second channel (12) a tube (50) is inserted, wherein a first longitudinal section (g) of the tube (50) into the first conduit section (46) and a second longitudinal section (h) of the tube (50) is inserted into the second conduit section (47), wherein with respect to an undeformed catheter line cross-section of the inner cross-section, in particular the inner diameter of the second channel (12) klei - ner, in particular slightly smaller than the outer cross section, in particular as the outer diameter of the tube (50).

14. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the connection device (6) facing away from the longitudinal end (48) of the first line section (46) and the balloon (3) facing away from the longitudinal end ( 49) of the second line section (47) are spaced apart from each other only with a thin gap or touch each other and in particular with each other, in particular cohesively, connected, for example. Glued together, are.

15. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the catheter line (2) at least a first line section (65), a second line section (67) and a third line section (66), wherein the valve core (13) is inserted in the third conduit section (66) into the first channel (11) such that the valve section (13) is spaced longitudinally of the third conduit section (66) from its two longitudinal ends (68, 69) in that the first conduit section (65) is fixedly connected to the connection device (6) and the second conduit section (67) is fixedly connected to the balloon (3) in such a way that a first connecting tube (70) is provided, each in a longitudinal section in FIG the first channel (11) is inserted at each of a longitudinal end of the first and the third line section (65, 66) that a second connecting tube (71) is provided, each in a longitudinal section in the first channel (11) is inserted at each one longitudinal end of the second and the third line section (67, 66), that a first connecting pipe (72) is provided, in each of a longitudinal section in the second channel (12) each one longitudinal end of the first and the third line section (65, 66) is inserted, and in that a second connecting tube (73) is provided, each in a longitudinal section in the second channel (12) at a respective longitudinal end of the second and the third Lei - Tung portion (67, 66) is inserted.

16. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that a filling device (74) is present, which comprises a hollow needle (75) and a housing (76) adjoining it, wherein at least one connection (77) for the supply of fluid, such as air, in particular for the releasable attachment of a syringe (18) or a fluid line or the like, is formed on the filling device (74) in that a housing (76) extending fluid passage (78) is in fluid communication with the port (77) and with 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).

17. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the outer diameter (u) of the hollow needle (75) by a few tenths or hundredths of a millimeter larger than the inner diameter (v) of the first channel (11) is, so that the hollow needle (75) after a separation of the valve (28) from a further connected to the balloon (3) length portion (85) of the catheter line (2) at its formed during the separation of the proximal longitudinal end (86) in the first Channel (11) while achieving a plug-clamp connection (88) can be inserted.

18. Balloon catheter (1) according to one or more of the preceding claims or in particular according thereto, characterized in that the filling device (74) comprises a stylet (81), which can pass through the connection (77), through the fluid passage (78) in the housing (76) and pass through the hollow needle (75) or remove from the filling device (74).

19. Balloon catheter (1,) according to one or more of the preceding claims or in particular according thereto, characterized in that the catheter line (2) between the valve (28) and the balloon (3) severed, in particular cut, and that the hollow needle ( 75) is plugged into the first channel (11) at the proximal longitudinal end (86) of the longitudinal section (85) of the catheter line (2) which is still connected to the balloon (3) to obtain a plug-in clamping connection (88).

20. A method of using a balloon catheter (1), comprising the steps of providing a balloon catheter (1) and delivering of fluid in its balloon (3), characterized in that a balloon catheter (1) according to one or more of the preceding claims 1 to 19 is provided, that through the first port (7) and the first channel (11) fluid into the balloon interior (4), so that the balloon (3) widens as a result of the increasing internal pressure, and that later the catheter line (2) cuts between the valve (28) and the connection device (6), in particular at the first marking , in particular cut, and the connection device (6) is removed from the remaining balloon catheter (1).

21. Method according to the preceding claim or in particular according thereto, characterized in that the balloon catheter (1), before the balloon (3) is expanded by means of fluid supply, with the balloon (3) ahead, in particular along a guide wire (53) or mandrin ( 81) through the working channel (58) of a first endoscope (59) until the balloon (3) is beyond the distal longitudinal end of the working channel (58), the connector means (6) being outside the working channel (58) ,

22. The method according to one or more of the preceding claims or in particular according thereto, characterized in that the first endoscope (59) after cutting the catheter line (2) in the direction away from the inflated balloon (3), ie in the proximal direction, is completely withdrawn from the catheter line (2).

23. The method according to one or more of the preceding claims or in particular according thereto, characterized in that after the removal of the first endoscope (59), a second endoscope (64), which in particular has a smaller outer diameter than the first endoscope (59) with a Working channel on the connected to the balloon (3) catheter line (2) in the distal direction is pushed so far that the balloon (3) is still outside the working channel.

24. The method according to one or more of the preceding claims or in particular according thereto, characterized in that after the pushing on of the second endoscope (64) on the catheter line (2) the valve (28) of the connected to the balloon (3) catheter line (2 ), in particular at the second marking (40) and in particular by cutting the catheter line (2) is separated, so that fluid escapes and the balloon (3) contracts.

25. The method according to one or more of the preceding claims or in particular according thereto, characterized in that after the contracting of the balloon (3) of the balloon (3) and the catheter line connected thereto (2) in the proximal direction from the working channel of the second endoscope (64 ) are pulled out.