DE102013101338A1 - Balloon catheter used for treatment of aneurysms, has connecting channel portion that is formed in catheter shaft and inlet opening that is fluidly connected with outlet opening - Google Patents

Abstract

The catheter has an inflatable balloon (11) in the distal region of a catheter shaft (10), and a vent passage (12) with an inlet opening (15) and an outlet opening (17) for escaping fluid from the balloon. A guide channel (14) is formed in the catheter shaft distal to balloon and a closure unit (13) closes the vent passage. A connecting channel portion (16) is formed in the catheter shaft and the inlet opening is fluidly connected with the outlet opening. The guide channel and connecting channel portion are provided such that vent passage is closed by closure unit. An independent claim is included for a method of flushing balloon catheter.

Description

The invention relates to a balloon catheter and to a method for rinsing a balloon catheter. Balloon catheters are used, for example, for the treatment of aneurysms. In this case, the aneurysm to be treated is filled with coils, which are introduced into the aneurysm through a coil catheter. In order to prevent the coil catheter from slipping out of the aneurysm during the coiling process, the balloon catheter is used as the second catheter, which on the one hand securely holds the coil catheter in the aneurysm and, on the other hand, supports the aneurysm neck. Such balloon catheters are also called balloon remodeling catheters.

The balloon catheter is filled with a contrast agent outside the patient. The air from the catheter and the balloon must be completely evacuated. For this purpose, balloon catheters are available, which have a catheter shaft and an inflatable balloon, which is arranged in the distal region of the catheter shaft. The balloon has a vent channel with an inlet and an outlet opening through which gaseous fluid in the balloon can escape from the balloon. The exit opening is located distally outside the balloon. Such a venting channel, a so-called "purge-hole", is a very small channel through which air can escape when the balloon is filled with contrast medium solution proximally. Once the catheter shaft and balloon are filled with the contrast agent solution and the air is completely displaced, the system automatically closes due to the viscosity of the contrast agent solution. Ambient air can then not enter the system. For this purpose, the known "purge-holes" on a very small diameter.

The disadvantage of these known balloon catheters is that the filling with the contrast agent solution takes a relatively long time. The time required for the system to be free of air can be up to 20 minutes. In addition, the deflating of the balloon in the patient is made more difficult, for example, when the balloon is to be repositioned during the aneurysm treatment. During deflating, the purge channel draws blood components, such as blood plasma, into the balloon, thereby diluting the balloon solution in the balloon. When re-inflation of the balloon therefore the radiopacity is greatly reduced. This has the consequence that a safe inflation of the balloon, in which the bursting risk is to be avoided, is difficult or even impossible. Moreover, the doctor can no longer control how the balloon behaves in the vessel. Another disadvantage is that it can come through the "purge-holes" to a gradual deflating of the balloon.

The invention is based on the object to improve a balloon catheter of the type mentioned with regard to its venting properties. The invention is further based on the object to provide a method for rinsing a balloon catheter.

According to the invention this object is achieved by a balloon catheter having the features of claim 1. With regard to the method, the object is achieved by the subject matter of claim 11.

The invention is based on the idea of specifying a balloon catheter with a catheter shaft and an inflatable balloon, which is arranged in the distal region of the catheter shaft and has a ventilation channel with an inlet opening and an outlet opening. Through the vent channel, fluid in the balloon can escape from the balloon. The exit opening is located distally outside the balloon. In the catheter shaft at least a first guide channel is formed distal to the balloon. For closing the ventilation channel at least one closure means is provided, which is arranged movably in the first guide channel. The venting channel has a connecting channel section, which is formed in the catheter shaft and fluidly connects the inlet opening with the outlet opening. The guide channel and the connecting channel section are connected in such a way that the ventilation channel can be closed by the closing means.

The invention has several advantages.

The venting channel can be closed by actuation of the closure means. The ability to close the vent channel, the balloon filling procedure is accelerated, since the flow cross-section of the vent passage in comparison to the known "purge-holes" can be increased. With the invention, filling times of 5 min. or less possible. The closeability of the venting channel, and thus the balloon, improves balloon radiopacity compared to known balloon catheters, since dilution of the contrast agent solution is avoided. In addition, an unwanted deflation of the balloon is prevented.

The catheter shaft is simple compared to proximal irrigation systems and provides safe and reliable functionality. For this purpose, a first guide channel is formed in the catheter shaft distal to the balloon, which is connected to the connecting channel section. The closure means movably arranged in the guide channel can be moved into the connection channel section for closing the ventilation channel, whereby the ventilation channel is moved through the ventilation channel Locking means is blocked. As a result, the fluid connection between the inlet opening and the outlet opening of the ventilation channel is interrupted, so that in the closed position of the closure means no ambient fluid, ie air or blood, can penetrate into the balloon. For this purpose, the closure means is arranged in the blocking state sealing in the connecting channel section. In other words, the closure means and the connecting channel section are each dimensioned such that the connecting channel section can be sealed by the closure means. The shape of the connection channel section corresponds to the shape of the closure means. In addition, the closure means may be arranged sealingly in the first guide channel.

Although is off US 5,224,933 a balloon catheter is known which has a flushing device. The flushing device comprises a bypass line arranged proximally of the balloon, in which a check valve is arranged. To rinse the balloon, it is filled with a contrasting lumen filling the air in the balloon in the bypass line and collects there. To vent the check valve is opened and sucked the air collected in the bypass line. Due to the complex structure of this venting system, this can only be used extracorporeal.

Preferred embodiments of the invention are specified in the subclaims.

Thus, the connecting channel section may have at least one deflection, in the region of which the first guide channel and the connecting channel section are connected. The deflection of the connection channel section allows for a fork of the channel system, wherein a first channel arm, i. H. a part of the connecting channel portion, is connected to the outlet opening. A second channel arm forms the guide channel. The fork allows almost any arrangement of the outlet opening relative to the guide channel. For example, the outlet opening may be formed as a lateral opening in the catheter shaft wall. In other words, the first guide channel opens in the region of the deflection in the connecting channel section. The position of the outlet opening is substantially independent of the position of the first guide channel.

In a further embodiment, the connecting channel section may have two deflections, wherein a first deflection of the inlet opening and a second deflection of the outlet opening is associated. For example, the connecting channel section may be U-shaped in cross section, so that both the inlet opening and the outlet opening are each formed in the side wall of the catheter shaft. Such channel shapes can be made by extrusion. Another way of producing can be done by shrinking plastics with an inserted mandrel (mandrel), which is later removed (fuse-down method). The production of channels in a catheter wall is familiar to the person skilled in the art. Other forms of the connecting channel section are possible.

Preferably, the connecting channel section and the first guide channel are at least partially aligned. As a result, the insertion of the closure means from the guide channel is simplified in the connecting channel section.

When the connection channel portion and the first guide channel extend parallel to the longitudinal axis of the catheter shaft, this portion of the catheter shaft can be particularly compact, i. H. are made with a small outer diameter, since little space is required for the formation of the connecting channel section and the guide channel in the radial direction.

In a further preferred embodiment, the closure means projects in the open position from the distal end of the catheter shaft in the longitudinal axial direction. Thereby, the closure means can be easily operated by the protruding part of the closure means in the catheter shaft, for example manually pushed.

The closure means may expediently form an elongate stopper, for example in the form of a pin, in particular a wire pin. In this case, a single stopper may be provided. The efficiency can be improved if a plurality of elongate plugs distributed in the circumferential direction of the catheter shaft or, in general, closure means are arranged in corresponding first guide channels. As a result, a plurality of correspondingly arranged ventilation channels can be closed. For the construction of the individual ventilation channels, reference is made to claim 1 and the appended description.

Alternatively, the closure means ( 13 ) have a sleeve and the first guide channel ( 14 ) form a corresponding annular channel concentrically in the catheter shaft ( 10 ) is arranged. In the annular channel open at least a single inlet and outlet opening, in particular a plurality of inlet and outlet openings. The openings are closed centrally in the locked state of the sleeve.

To further simplify the operation of the closure means of the catheter shaft may have a second guide channel, in which an actuating means for applying the Closing means is arranged movable with a closing force. This has the advantage that the actuating means can be formed in comparison to the closure means with a larger diameter or generally larger, whereby the manual operation of the closure means is simplified. In addition, the safety of the system is improved, wherein the larger dimensions of the actuating means this is more robust than the closure means.

The first and second guide channels can run parallel. This causes the closing movements of the actuating means and the closure means to take place in the same direction.

The actuating means may comprise a guide portion and a projection projecting laterally over the guide portion and abutting the closure means for transmitting the closing force. Such an actuator is easy to manufacture and allows safe operation of the closure means.

The invention will be explained in more detail by means of embodiments with reference to the accompanying schematic drawings.

In these show:

1 A longitudinal section through a balloon catheter in the region of the catheter tip according to an embodiment of the invention, wherein the closure means is in the open position;

2 the balloon catheter according to 1 wherein the closure means is arranged in an intermediate position;

3 according to the balloon catheter 1 wherein the closure means is arranged in the closed position;

4 according to the balloon catheter 1 wherein the actuating means is removed from the catheter;

5 according to the balloon catheter 1 in operational condition after completion of the flushing process;

6 a longitudinal section through a balloon catheter in the region of the catheter tip according to a further embodiment of the invention with a plurality of closure means and

7 a plan view of the catheter tip according to 6 ,

In the 1 - 5 an example of a balloon catheter according to the invention is shown, which can be used as a balloon remodeling catheter to assist the treatment of aneurysms. The invention is not limited to this application, but is applicable to other dilatation catheters in which the balloon and / or the catheter shaft are flushed to remove air in the system.

The balloon catheter according to 1 includes a catheter shaft 10 and an inflatable balloon 11 , The balloon 11 has a vent channel 12 with an inlet and outlet opening 15 . 17 through which gaseous fluid in the balloon can escape from the balloon. The balloon catheter also has a first guide channel 14 , a means of closure 13 and a connection channel section 16 on. The abovementioned components are respectively integrated into the catheter shaft or in the catheter shaft 10 arranged and form part of the balloon catheter, as described in more detail below:
The catheter shaft 10 is a per se known elongate, tubular member made of a flexible material. The manufacture of the catheter shaft 10 usually takes place by extrusion. For this purpose, suitable materials are selected, such as PVC or the like. The catheter shaft 10 has a (not shown) proximal end to which connections are provided in a conventional manner. For example, a Y-Luer connector may be provided for the delivery of a guidewire and for connection to a liquid supply for the contrast agent solution. Other connectors or connectors are possible to which medical devices such as syringes, cannulas, tubing and the like can be connected.

In the 1 illustrated distal tip of the catheter shaft 10 is atraumatic and is placed in use in a conventional manner in the vessel. The catheter shaft of the embodiment according to 1 has two lumens.

Generally, a multi-lumen catheter shaft is usable within the scope of the invention. In this case, a central lumen is used to receive a guide wire (not shown) and / or for drug delivery. The central lumen has another function described in detail elsewhere and serves as a second guide channel 19 for the actuating means 18 , Also not shown is the lumen for delivery of the contrast agent solution to the balloon 11 located in the area of the distal end of the catheter shaft 10 is arranged. The formation of the contrast agent supply and the central lumen for the guide wire is carried out in a conventional manner.

In the distal area of the catheter shaft 10 is the balloon 11 arranged with a contrast medium solution or another fluid for Inflating can be filled. The filling of the balloon 11 via the above-mentioned supply device, which in 1 not shown. The fluid-tight connection of the balloon 11 with the catheter shaft 10 takes place in a conventional manner. The balloon 11 is deflatable, for example, for repositioning the balloon catheter during aneurysm treatment. The aspiration of the contrast agent solution can be done by the contrast agent or by a separate suction. For this purpose, systems known per se can be used, for example a syringe, in particular a syringe with a 3-way stopcock as a pressure barrier.

The balloon 11 is from the distal end 23 of the catheter shaft 10 spaced. The balloon 11 has a cylindrical outer circumference with a tapered distal end, as in FIG 1 shown. Other balloon shapes are possible.

As in 1 to see, the balloon catheter has a vent channel 12 on, by the balloon 11 located gaseous fluid can escape from the balloon. The flow path of the fluid, usually air, is indicated by four arrows in 1 clarified. The ventilation duct 12 has an inlet opening 15 on, in the outer wall 24 of the catheter shaft 10 is trained. The entrance opening 15 So it is on the side of the catheter shaft 10 arranged and flows into the balloon 11 , as in 1 shown. In the example according to 1 is the entrance opening 15 in the area of the distal end of the balloon, specifically in the area of the conical rejuvenation of the balloon 11 arranged. This has the advantage of being at the proximal filling of the balloon 11 with contrast medium solution collecting air can be effectively dissipated at the distal end of the balloon. Another arrangement of the inlet opening 15 relative to the balloon 11 is possible.

The ventilation duct 12 has an outlet opening 17 on, which is arranged outside the balloon. Specifically, the outlet opens 17 in the environment, leaving the balloon 11 through the venting channel 12 escaping air escapes into the atmosphere. The outlet opening 17 is in the outer wall 24 of the catheter shaft 10 , ie laterally in the catheter shaft 10 educated.

The entrance opening 15 and the exit opening 17 may be circular. Other opening shapes are possible, for example slot-shaped openings which extend in the circumferential direction, or oval openings.

The ventilation duct 12 has a connection channel section 16 on, in the catheter shaft 10 is trained. The connection channel section 16 is specifically formed in the material of the distal catheter tip and thus forms part of the catheter tip. The connection channel section 16 puts between the inlet 15 and the exit opening 17 made a fluid connection, so that in the balloon 11 located fluid through the inlet opening 15 over the connecting channel section 16 to the outlet 17 arrives. In the example according to 1 corresponds to the diameter of the connecting channel section 16 the diameters of the inlet opening 15 and the exit opening 17 , Other diameter ratios are possible.

As in 1 to see, has the connecting channel section 16 at least one diversion 22 , specifically two deflections 22 on. A deflection is understood to be a channel section which deflects the air or fluid flowing in the channel, that is to say causes a change in direction. This is in 1 through the arrows oriented in different directions in the area of the ventilation channel 12 clarified. In the example according to 1 has the connection channel section 16 a 90 ° deflection 22 on that with the outlet 17 connected is. Other deflection angles are possible, for example in a range of 45-90 °, in particular 60-90 °, in particular 75-90 °.

The ventilation duct 12 has another diversion 22 on that with the entrance opening 15 connected is. The features associated with the diversion 22 for the outlet 17 are also described in connection with the diversion 22 for the entrance opening 15 disclosed. Together, the two deflections 22 a cross-sectionally substantially U-shaped connecting channel section 16 ,

In other words, the connection channel section 16 from three thighs 25 . 26 . 27 built, with two legs 25 . 26 directly with the entrance opening 15 or the outlet opening 17 are connected and the third leg 27 between the first and second legs 25 . 26 extends. The third leg 27 is through the two deflections 22 each with the first and the second leg 25 . 26 connected. The first and second thighs 25 . 26 extend substantially parallel to each other. The third leg 27 extends substantially at an angle of 90 ° with respect to the first and second legs 25 . 26 ,

As in 1 To recognize, the balloon catheter has a first guide channel 14 in which a closure means 13 , For example, in the form of an elongated plug, movable, in particular longitudinally movable, is arranged. The guide channel 14 has an outer opening 28 on that in the face of the distal catheter tip 23 is trained. Through the outer opening 28 becomes the closing agent 13 in the guide channel 14 introduced. The first guide channel 14 is with the Connecting channel section 16 connected. The purpose of this connection is that in the guide channel 14 movably arranged closure means 13 for closing the ventilation channel 12 in the connection channel section 16 can be moved into it.

The connection takes place in the region of the distally arranged deflection 22 connected to the outlet 17 connected is. As in 1 to recognize, aligned the connecting channel section 16 and the first guide channel 14 , Specifically, the third leg are aligned 27 and the first guide channel 14 , This has in addition to the rectilinear closing movement of the closure means 13 the manufacturing advantage that the connecting channel section 16 can be made by a simple hole in the catheter tip. The two first and second thighs 25 . 26 of the venting channel 12 can be made by appropriate lateral holes.

The channels or channel sections described above, but at least the first guide channel 14 and the connection channel section 16 have a circular cross-section. The closure means 13 also has a circular cross-section and is to the shape and diameter of the first guide channel 14 and the connecting channel section 16 adjusted so that a sealing effect is achieved.

The parallel arrangement of the connecting channel section 16 and the first guide channel 14 relative to the longitudinal axis of the catheter shaft 10 on the one hand simplifies the manufacture and on the other hand allows a compact design of the catheter tip 23 because no additional space is required for the arrangement of the channels. Another, for example, not parallel arrangement is possible.

The length of the closure means 13 is dimensioned so that this in the open position from the distal end of the catheter shaft or from the catheter tip 23 projecting in the longitudinal axial direction, as in 1 shown. In the open position, the closure means 13 the venting channel 12 , specifically the outlet 17 free. The protruding part of the closure 13 will close the balloon 11 into the catheter tip 23 inserted. The required closing force is achieved by an actuating means 18 applied. The actuating means 18 is in a second guide channel 19 arranged longitudinally displaceable or generally movable. The second guide channel 19 corresponds to the central lumen of the catheter shaft 10 through which the guidewire passes when the balloon catheter is placed. The central lumen may perform other functions, such as delivery of a solution or delivery of other medical devices, such as a thrombectomy device. Due to the double function of the second guide channel 19 the structure of the balloon catheter is simplified.

The actuating means 18 has a guide section 20 on, in the second guide channel 19 is arranged longitudinally displaceable. The guide section 20 is with a lead 21 connected laterally over the guide section 20 protrudes. The lead 21 is so wide that this is the closure means 13 parallel to the guide section 20 is arranged, overlaps. For closing the projection beats 21 at the closure means 13 on, so that the closing force of the actuating means 18 on the closure means 13 can be transferred. In practice, the closing force is applied manually.

In the example according to 1 forms the actuating means a cross-sectionally T-shaped plug. Other cross sections are possible.

The balloon catheter according to 1 works as follows:

1 shows the closure means 13 in the open position. The ventilation duct 12 is released so that between the interior of the balloon 11 and the environment is in fluid communication. The balloon 11 and the catheter shaft 10 are filled from the proximal end via the Luer connector with a contrast agent solution. It escapes through the venting channel 12 the air from the balloon 11 and the one with the balloon 11 connected supply line (not shown). The ventilation duct 12 is greater than the purge-holes known in the art. This is possible because of the venting channel 12 is closable and thus the channel diameter for the closing function is not critical in contrast to known purge-holes. The air can escape comparatively faster and the contrast medium solution floods the entire catheter faster. If the balloon 11 is filled, the contrast medium solution or generally the liquid fluid flows, for example. A NaCl solution from the vent passage 12 ,

Then, as in 2 shown, the actuating means 18 in the catheter tip or concretely in the second guide channel 19 pressed. The closing direction is in 2 represented by the big arrow. The actuating means 18 takes the closure means 13 with, which moves in the proximal direction. This is the closing means 13 in the connection channel section 16 moves in and blocks the outlet opening 17 , as in 2 shown. Already in this intermediate state, an interruption of the fluid connection between the balloon and the environment is achieved. In this condition, no air can enter the system.

As in 3 is shown, the actuating means 18 completely into the catheter tip 23 pushed. The same applies to the closure means 13 in this state, flush with the end face of the catheter tip 23 concludes. In this state, the closure means closes 13 both the outlet opening 17 as well as the entrance opening 15 of the venting channel 12 ,

As in 4 is shown, the actuating means 18 then from the catheter shaft 10 away, ie moved in the distal direction.

After the actuating means 18 completely out of the catheter shaft 10 pulled out, as in 5 shown, the balloon catheter is ready for use. The closure means 13 closes flush and thus atraumatic with the catheter tip 13 from.

The balloon 11 can now be deflated and inflated in the body without passing through the venting channel 12 Air or blood or blood plasma in the balloon 11 arrives, because the venting channel 12 through the closure means 13 is locked.

As in 5 to see corresponds to the length of the closure means 13 the distance between the inlet opening 15 and the face of the catheter tip 23 , Specifically, the distance between the proximal edge of the inlet opening 15 and the end surface of the distal catheter tip 23 ,

A variant of the balloon catheter according to 1 is in 6 . 7 shown, the plurality of circumferentially distributed closure means arranged 13 having, in corresponding first guide channels 14 are arranged. The top view of the catheter tip in 7 shows 6 first guide channels 14 concentrically around the second guide channel 19 are arranged around. Another number, for example at least two guide channels 14 is possible.

The associated ventilation channels 12 are structured accordingly. In other words, the related 1 to 5 described venting channel 12 , the first guide channel 14 and the closure means 13 arranged several times in the circumferential direction of the catheter shaft. All in connection with the execution according to 1 to 5 disclosed features are also in connection with the embodiment according to 6 . 7 disclosed.

Another possibility, not shown, is the guide channels 14 according to 7 to connect to a continuous annular channel, in which a closure sleeve is inserted. The longitudinal section of this embodiment would be according to the illustration 6 correspond, wherein instead of the pins a sleeve is provided.

LIST OF REFERENCE NUMBERS

10

catheter shaft

11

balloon

12

vent channel

13

closure means

14

guide channel

15

inlet opening

16

Connecting channel section

17

outlet opening

18

actuating means

19

guide channel

20

guide section

21

head Start

22

redirection

23

Distal end of the catheter shaft

24

Outside wall of the catheter shaft

25, 26, 27

leg

28

opening

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 5224933 [0010]

Claims (14)

Balloon catheter with a catheter shaft ( 10 ), an inflatable balloon ( 11 ) located in the distal area of the catheter shaft ( 10 ) is arranged, and a venting channel ( 12 ) with an inlet opening ( 15 ) and an exit opening ( 17 ), by the balloon ( 11 ) located fluid from the balloon ( 11 ), wherein the outlet opening ( 17 ) distally outside the balloon ( 11 ), characterized by - at least one first guide channel ( 14 ) in the catheter shaft ( 10 ) distal to the balloon ( 11 ), - at least one closure means ( 13 ) for closing the venting channel ( 12 ) in the first guide channel ( 14 ) is movably arranged, and - a connecting channel section ( 16 ) in the catheter shaft ( 10 ) is formed and the inlet opening ( 15 ) with the outlet opening ( 17 ), wherein the first guide channel ( 14 ) and the connection channel section ( 16 ) are connected such that the venting channel ( 12 ) by the closure means ( 13 ) is closable. Balloon catheter according to claim 1, characterized in that the connecting channel section ( 16 ) at least one diversion ( 22 ), in the region of which the first guide channel ( 14 ) and the connection channel section ( 16 ) are connected. Balloon catheter according to claim 1 or 2, characterized in that the connecting channel section ( 16 ) and the first guide channel ( 14 ) are at least partially aligned. Balloon catheter according to one of the preceding claims, characterized in that the connecting channel section ( FIG. 16 ) and the first guide channel ( 14 ) parallel to the longitudinal axis of the catheter shaft ( 10 ). Balloon catheter according to one of the preceding claims, characterized in that the closure means ( 13 ) in the open position from the distal end of the catheter shaft ( 10 ) protrudes in the longitudinal axial direction. Balloon catheter according to one of the preceding claims, characterized in that the closure means ( 13 ) has an elongated plug. Balloon catheter according to one of the preceding claims, characterized in that several in the circumferential direction of the catheter shaft ( 10 ) arranged elongated plugs in corresponding first guide channels ( 14 ) are arranged. Balloon catheter according to one of claims 1 to 5, characterized in that the closure means ( 13 ) has a sleeve and the first guide channel ( 14 ) forms a corresponding annular channel concentrically in the catheter shaft ( 10 ) is arranged. Balloon catheter according to one of the preceding claims, characterized in that the catheter shaft ( 10 ) a second guide channel ( 19 ), in which an actuating means ( 18 ) for loading the closure means ( 13 ) is arranged movably with a closing force. Balloon catheter according to claim 9, characterized in that the first and second guide channel ( 14 . 19 ) run parallel. Balloon catheter according to claim 9 or 10, characterized in that the actuating means ( 18 ) a guide section ( 20 ) and a lead ( 21 ) which laterally over the guide portion ( 20 ) and on the closure means ( 13 ) strikes to transmit the closing force. Balloon catheter according to one of claims 9 to 11, characterized in that the actuating means ( 18 ) forms a cross-sectionally T-shaped plug. Balloon catheter according to one of claims 1 to 12, characterized in that the closure means ( 13 ) is made of a radiopaque material. A method of flushing a balloon catheter according to any one of claims 1 to 13, characterized in that after the complete escape of the fluid from the balloon ( 11 ) the venting channel ( 12 ) by the closure means ( 13 ) is closed.

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