DE102021106856A1 - Balloon dilatation catheter with two working channels for the use of two guide wires, in particular for endosonographically guided tissue puncture and placement of plastic stents in the upper GI tract - Google Patents

Abstract

The invention relates to a balloon catheter system (1) for draining fluid accumulations in a patient's gastrointestinal tract, comprising: a balloon (3) which can be dilated by introducing a fluid medium into an interior (30) of the balloon, a catheter shaft (2) which extends from a proximal end (2a) to a distal end (2c), the balloon (3) being arranged on a distal end section (2b) of the catheter shaft (2), and the catheter shaft (2) having a cavity (30 ) surrounding communicating lumen (23), via which the fluid medium can be introduced into the interior (30) to dilate the balloon (3), and wherein the catheter shaft (2) also has a first working channel (21) and a second working channel (21) separate therefrom 22), a first guide wire (51) which can be inserted into and guided through the first working channel (21) and a second guide wire (52) which can be inserted into the second working channel (22) and guided through it is audible.

Description

The invention relates to a balloon catheter system for draining fluid accumulations in a patient's gastrointestinal (GI) tract.

In the case of endosonographically-assisted puncture of fluid accumulations/infected tissue and placement of plastic stents in the upper GI tract, a guide wire is usually introduced after the puncture with a puncture needle and the puncture site is widened using a balloon catheter system that covers the puncture site in the area of the 8th mm to 20mm can stretch. The access created must be kept open so that the fluid can drain out of the cyst. Plastic stents, so-called pigtails, in various sizes are usually used for this purpose (usually 8 French to 10 French). The stents are placed over the guidewire and under X-ray control. In order to create an adequate flow, at least two stents are usually placed. Since only one guide wire can be placed through the balloon catheter used and at least two plastic stents have to be placed, the technical problem arises after the placement of the first stent over the guide wire under difficult local conditions of placing the guide wire again in the cyst. This step is time-consuming and its chances of success cannot be estimated. In case of doubt, a new separate examination is necessary.

The alternative to the procedure described above is the placement of a metal stent. However, such a metal stent can be associated with major local complications and usually has to be removed after 3 to 4 weeks, cannot be replaced and is very expensive. Current studies have also shown that such a metal stent (except for the length of the examination) offers no advantages over the use of plastic stents.

Proceeding from this, the invention is based on the object of providing a balloon catheter system of the type mentioned at the outset, which is improved with regard to the problems mentioned above.

This problem is solved by a balloon catheter system having the features of claim 1. Advantageous refinements of the invention are specified in the corresponding dependent claims and are described below.

• - einem Ballon, der durch Einleiten eines fluiden Mediums in einen Innenraum des Ballons dilatierbar bzw. entfaltbar ist,
• - einem Katheterschaft, der sich von einem proximalen Ende zu einem distalen Ende erstreckt, wobei der Ballon an einem distalen Endabschnitt des Schafts angeordnet ist, und wobei der Schaft ein mit dem Innenraum kommunizierendes Lumen umgibt, über das das fluide Medium in den Innenraum einleitbar ist, und wobei der Schaft weiterhin einen ersten Arbeitskanal sowie einen dazu separaten zweiten Arbeitskanal aufweist,
• - einen ersten Führungsdraht, der in den ersten Arbeitskanal einführbar und durch diesen führbar ist, und
• - einen zweiten Führungsdraht, der in den zweiten Arbeitskanal einführbar und durch diesen führbar ist.

According to claim 1 there is disclosed a balloon catheter system for draining fluid accumulations in a patient's gastrointestinal tract, comprising:

• - a balloon which can be dilated or unfolded by introducing a fluid medium into an interior space of the balloon,
• - A catheter shaft, which extends from a proximal end to a distal end, wherein the balloon is arranged on a distal end portion of the shaft, and wherein the shaft surrounds a communicating with the interior lumen through which the fluid medium can be introduced into the interior , and wherein the shaft also has a first working channel and a second working channel separate therefrom,
• - a first guide wire which can be inserted into and guided through the first working channel, and
• - A second guide wire which can be inserted into and guided through the second working channel.

The balloon catheter system according to the invention thus allows two guide wires to be easily placed in a cyst or in a punctured tissue, so that after dilation of the access route, a first stent (e.g. 8 French) and then a second stent (e.g. 10 French) can be easily placed can be.

According to one embodiment of the invention, it is provided that the catheter shaft has a length of at least 180 cm.

Furthermore, according to an embodiment of the invention it is provided that the catheter shaft has a maximum diameter which is smaller than 3.2 mm (e.g. 8 French or 9 French).

Furthermore, according to one embodiment of the invention, it is provided that the catheter shaft extends longitudinally in an axial direction. The catheter shaft is preferably flexible so that it can follow a curved access path or lumen in the patient's body.

Furthermore, according to one embodiment of the invention, it is provided that the balloon has a length in the axial direction that is less than or equal to 60 mm.

Another embodiment of the invention provides that the catheter shaft has a catheter tip that extends from a distal end of the balloon to the distal end of the shaft, the catheter tip having a first opening through which the first guide wire can be guided out of the first working channel and wherein the catheter tip has a second opening through which the second guide wire can be guided out of the second working channel. Before It is preferably provided that the catheter tip has a length in the axial direction that is less than or equal to 10 mm.

According to a further embodiment of the balloon catheter system, it is provided that it has a first and a second X-ray marking, which are opposite one another, in particular in the axial direction. The two X-ray markers are preferably arranged in the interior of the balloon.

According to a further embodiment of the invention, it is provided that the first and the second working channel of the catheter shaft each have an inside diameter that is less than or equal to 1 mm.

According to one embodiment, the first working channel can be formed by a first tube, for example. Furthermore, the second working channel can be formed by a second hose. The first tube is preferably arranged in the lumen of the catheter shaft. Furthermore, the second hose is preferably also arranged in the lumen of the catheter shaft. The two working channels are thus embedded in the lumen of the catheter shaft, via which the fluid medium is introduced into the interior of the balloon in order to dilate the balloon, or via which the fluid medium is withdrawn from the interior of the balloon again to deflate the balloon .

For example, the particular guidewire may have an outer diameter of no more than 0.035 inch, i.e. 0.89 mm (e.g. Jagwire from Boston Scientific).

Furthermore, the two openings of the working channels are preferably arranged at the catheter tip in such a way that the two guide wires can emerge parallel to the axial direction on the catheter shaft or out of the catheter tip, i.e. in a straight direction.

A further aspect of the present invention relates to a medical system for puncturing tissue of a patient with the features of claim 11. Accordingly, the medical system has an ultrasonic endoscope which has a working channel, a puncture needle which can be inserted into the working channel of the ultrasonic endoscope for puncturing the tissue, and a balloon catheter system according to the invention, wherein the catheter shaft of the balloon catheter system can be inserted into the working channel of the ultrasonic endoscope.

• - Einführen des Ultraschallendoskops in den Patienten sowie Erzeugen eines Ultraschallbildes des zu punktierenden Gewebes mittels des Ultraschallendoskops,
• - Einführen der Punktionsnadel in den Arbeitskanal des Ultraschallendoskops und Punktieren des Gewebes mittels der Punktionsnadel,
• - Platzieren des ersten Führungsdraht in den punktierten Bereich über die Punktionsnadel (z.B. durch ein Lumen der Punktionsnadel hindurch),
• - Entfernen der Punktionsnadel aus dem Arbeitskanal des Ultraschallendoskops unter anhaltender Lagekontrolle des ersten Führungsdrahts,
• - Einführen des Katheterschafts über den ersten Führungsdraht in den Arbeitskanal des Ultraschallendoskops und Positionieren des Ballons in einer durch die Punktion des Gewebes erzeugten Öffnung des Gewebes sowie Einleiten eines fluiden Mediums in den Innenraum des Ballons zum Aufweiten der Öffnung,
• - Platzieren des zweiten Führungsdrahts im Bereich des punktierten Gewebes über den zweiten Arbeitskanal des Katheterschafts,
• - Entfernen des Katheterschafts sowie Setzen eines ersten Stents (z.B. 8 French) in die Öffnung über den ersten Führungsdraht und anschließende Entfernung des ersten Führungsdrahtes aus dem Arbeitskanal des Ultraschallendoskops, und
• - Setzen eines zweiten Stents (z.B. 10 French) in die Öffnung (benachbart zum ersten Stent) über den zweiten Führungsdraht und Entfernung des zweiten Führungsdrahtes.

A further aspect of the present invention relates to a method according to claim 12 for puncturing tissue of a patient, in particular in the gastrointestinal tract of a patient, using a medical system or balloon catheter system according to the invention, the method having the steps:

• - Inserting the ultrasonic endoscope into the patient and generating an ultrasonic image of the tissue to be punctured using the ultrasonic endoscope,
• - Inserting the puncture needle into the working channel of the ultrasonic endoscope and puncturing the tissue with the puncture needle,
• - Place the first guide wire in the punctured area over the puncture needle (e.g. through a lumen of the puncture needle),
• - Removal of the puncture needle from the working channel of the ultrasonic endoscope while continuously checking the position of the first guide wire,
• - Inserting the catheter shaft over the first guide wire into the working channel of the ultrasonic endoscope and positioning the balloon in an opening in the tissue created by the puncture of the tissue and introducing a fluid medium into the interior of the balloon to expand the opening,
• - Placement of the second guide wire in the area of the punctured tissue via the second working channel of the catheter shaft,
• - Removal of the catheter shaft and placement of a first stent (eg 8 French) in the opening over the first guide wire and subsequent removal of the first guide wire from the working channel of the ultrasound endoscope, and
• - Place a second stent (eg 10 French) in the opening (adjacent to the first stent) over the second guidewire and remove the second guidewire.

• 1 eine schematische Ansicht einer Ausführungsform eines erfindungsgemäßen Ballonkathetersystems.
• 2 eine geschnittene Ansicht des Katheterschafts des Ballonkathetersystems der 1 entlang der Ebene II-II der 1.
• 3 eine geschnittene Ansicht des Ultraschallendoskops neben einer zu punktierenden Flüssigkeitsansammlung im Gastrointestinaltrakt, beispielsweise einer Zyste, wobei sich eine zur Punktion ausgebildete Nadel im Arbeitskanal des Ultraschallendoskops befindet.
• 4 eine geschnittene schematische Ansicht des Ultraschallendoskops neben einer punktierten Flüssigkeitsansammlung im Gastrointestinaltrakt, beispielsweise einer Zyste, wobei sich ein über die Punktionsnadel geführter erster Führungsdraht im Arbeitskanal des Ultraschallendoskops befindet.
• 5 eine geschnittene schematische Ansicht des Ultraschallendoskops neben einer punktierten Flüssigkeitsansammlung im Gastrointestinaltrakt, beispielsweise einer Zyste, wobei das Ultraschallendoskop über den ersten Führungsdraht in Position gehalten wird.
• 6 eine geschnittene schematische Ansicht des Ultraschallendoskops neben einer punktierten Flüssigkeitsansammlung im Gastrointestinaltrakt, beispielsweise einer Zyste, wobei sich das über den ersten Führungsdraht im ersten Arbeitskanal des Ballonkatheters geführte Ballonkathetersystem im Arbeitskanal des Ultraschallendoskops befindet.

Exemplary embodiments and further advantages and features of the invention are to be explained below with reference to the figures. Show it:

• 1 a schematic view of an embodiment of a balloon catheter system according to the invention.
• 2 a sectional view of the catheter shaft of the balloon catheter system of FIG 1 along the II-II level of the 1 .
• 3 a sectional view of the ultrasonic endoscope next to a fluid accumulation to be punctured in the gastrointestinal tract, such as a cyst, with a to Puncture-trained needle is located in the working channel of the ultrasonic endoscope.
• 4 a sectional schematic view of the ultrasonic endoscope next to a punctured accumulation of liquid in the gastrointestinal tract, for example a cyst, with a first guide wire guided over the puncture needle being in the working channel of the ultrasonic endoscope.
• 5 a sectional schematic view of the ultrasonic endoscope next to a punctured collection of fluid in the gastrointestinal tract, such as a cyst, wherein the ultrasonic endoscope is held in position over the first guide wire.
• 6 a sectional schematic view of the ultrasonic endoscope next to a punctured accumulation of liquid in the gastrointestinal tract, for example a cyst, the balloon catheter system guided over the first guide wire in the first working channel of the balloon catheter being located in the working channel of the ultrasonic endoscope.

1 shows related to 2 an embodiment of a balloon catheter system 1 according to the invention for draining fluid accumulations in the gastrointestinal tract of a patient. The balloon catheter system 1 has a balloon 3 which can be dilated by introducing a fluid medium into an interior space 30 of the balloon 3 . Furthermore, the balloon catheter system 1 has a catheter shaft 2 which extends from a proximal end 2a to a distal end 2c, the balloon 3 being arranged on a distal end section 2b of the catheter shaft 2 . The catheter shaft 2 defines a lumen 23 which is in flow communication with the interior 30 of the balloon 3 and via which the fluid medium can be introduced into the interior 30 for dilating the balloon 3 . Furthermore, the catheter shaft 2 has a first working channel 21 and a second working channel 22 separate therefrom, which are each set up for guiding a separate guide wire 51 or 52 (cf. 2 ).

The balloon catheter shaft 2 should have an overall length of approximately 180 cm and preferably a maximum diameter of less than 3.2 mm (e.g. 8 or 9 French).

The catheter shaft 2 of the balloon catheter system 1 is preferably intended exclusively for use in combination with an ultrasonic endoscope (e.g. with side view optics). Such a device is also referred to as an EUS puncture device and has a working channel that can be used for puncturing (e.g. with a puncture needle) or into which the balloon catheter system can be inserted.

According to 2 catheter shaft 2 has an outer diameter D of usually a maximum of 3.2 mm, so that shaft 2 can be inserted into working channels of commercially available ultrasonic endoscopes. Furthermore, the balloon 3 has an overall length L1 of max. 60 mm in the axial direction x. So that the balloon 3 can be placed under X-ray observation in, for example, an opening of a cyst to be dilated (after the puncture), the balloon 3 preferably has two X-ray markings 6, 7 (for example made of lead or other suitable metals). The tip 4 of the catheter shaft 2 is preferably at least 10 mm long and contains two openings 21a, 22a of the working channels 21, 22. The two working channels 21, 22 are preferably located centrally one above the other and in particular have a maximum diameter of 1 mm D1 or D2. The two working channels 21, 22 are preferably embedded in the insufflation channel or lumen 23 of the catheter shaft 2, which communicates with the interior 30 of the balloon 3. The two working channels 21, 22 should each preferably have the option of guiding a guide wire 51 or 52 (e.g. Jagwire from Boston Scientific with a size or outer diameter D3, D4 of e.g. a maximum of 0.035 inch (corresponds to 0.89 mm). Both guide wires 51 , 52 can be positioned in a straight line through the tip 4 (or its openings 21a, 22a) of the balloon catheter shaft 2 via the associated working channels 21, 22 of the catheter shaft 2.

The balloon catheter system 1 according to the invention is preferably used in combination with an ultrasonic endoscope 60 (cf. 3 ), which has a working channel 64 and an ultrasound head 61 designed for endosonography. For the drainage of fluid accumulations in the gastrointestinal tract, such as a cyst 62, it is preferable to first, as shown in 3 shown, a needle 63 designed for puncturing accumulations of fluid in the gastrointestinal tract is brought to the accumulation of fluid or cyst 62 via the working channel 64 of the ultrasound endoscope 60 with position monitoring by the ultrasound head 61 of the ultrasound endoscope 60, and this is then punctured with the aid of the needle 63. The needle 63 used can be a hollow needle, for example.

As in 4 shown, the first guide wire 51 is preferably inserted into the punctured cyst 62 via the needle 63 or hollow needle 63 after the puncture of the fluid accumulation 62 while the position of the ultrasound head 61 is continuously monitored.

Subsequent to the placement of the first guidewire 51 in the punctured fluid collection 62, the needle 63 used to puncture the fluid collection or cyst 62 is removed via the first guide wire 51 from the working channel 64 of the ultrasound endoscope 60, preferably while continuously monitoring the position of the ultrasound head 61, so that only the first guide wire 51 is still located there, as in 5 shown.

Subsequently, the balloon catheter system 1 according to the invention, as in 6 shown, introduced over the first guide wire 51 through the working channel 64 of the ultrasonic endoscope 60 to the cyst 62, while the first guide wire 51 is still held under the control of the ultrasonic head 61 in the cyst 62. The balloon catheter system 1 is preferably guided in such a way that the first guide wire 51 is located in the first of the two working channels 21, 22 according to the invention.

The balloon 3 can now be positioned in an opening in the tissue 62 created by the puncture of the tissue 62 , the opening being widened by introducing a fluid medium into the interior 30 of the balloon 3 . The second guide wire 51 is then placed in the area of the punctured tissue 62 via the second working channel (22) of the catheter shaft 2. The catheter shaft 2 is then removed and a first stent (e.g. 8 French) is inserted into the opening of the tissue 62 over the first Guide wire 51 set. The first guide wire is then removed. Finally, a second stent (e.g., 10 French) is placed in the opening of the tissue over the second guidewire 52 so that the second stent is adjacent to the first stent in the opening of the tissue 62.

Claims (12)

Balloon catheter system (1) for draining fluid accumulations in a patient's gastrointestinal tract, having: - a balloon (3) which can be dilated by introducing a fluid medium into an interior space (30) of the balloon (3), - a catheter shaft (2) extending from a proximal end (2a) to a distal end (2c), the balloon (3) being arranged at a distal end portion (2b) of the catheter shaft (2), and the catheter shaft (2) surrounding a lumen (23) communicating with the interior (30), via which the fluid medium can be introduced into the interior (30) to dilate the balloon (3), and wherein the catheter shaft (2) also has a first working channel ( 21) and a separate second working channel (22), - a first guide wire (51) which can be inserted into and guided through the first working channel (21), and - A second guide wire (52) which can be inserted into and guided through the second working channel (22). balloon catheter system claim 1 , characterized in that the catheter shaft (2) has a maximum diameter (D) which is less than 3.2 mm (eg 8 French or 9 French). balloon catheter system claim 1 or 2 , characterized in that the catheter shaft extends longitudinally in an axial direction (x). Balloon catheter system according to one of the preceding claims, characterized in that the balloon (3) has a length (L1) in the axial direction (x) which is less than or equal to 60 mm. Balloon catheter system according to one of the preceding claims, characterized in that the catheter shaft (2) has a catheter tip (4) which extends from a distal end (3a) of the balloon (3) to the distal end (2c) of the catheter shaft (2). , wherein the catheter tip (4) has a first opening (21a) through which the first guide wire (51) can be guided out of the first working channel (21), and wherein the catheter tip (4) has a second opening (22a) through which the second guide wire (52) can be guided out of the second working channel (22). balloon catheter system claim 5 , characterized in that the catheter tip (4) has a length (L2) in the axial direction (x) which is less than or equal to 10 mm. Balloon catheter system according to one of the preceding claims, characterized in that the balloon catheter system (1) has a first and a second X-ray marking (6, 7) which are opposite one another, in particular in the axial direction (x). Balloon catheter system according to one of the preceding claims, characterized in that the respective working channel (21, 22) has an inside diameter (D1, D2) which is less than or equal to 1 mm. Balloon catheter system according to one of the preceding claims, characterized in that the first working channel (21) is formed by a first tube (210) and/or that the second working channel (22) is formed by a second tube (220). balloon catheter system claim 9 , characterized in that the first hose (210) is arranged in the lumen (23) of the catheter shaft (2), and/or that the second tube (220) is arranged in the lumen (23) of the catheter shaft (2). Medical system for puncturing tissue (62), comprising: - an ultrasonic endoscope (60) having a working channel (64), - A puncture needle (63) that can be inserted into the working channel (64) of the ultrasonic endoscope (60) for puncturing the tissue (62), and - A balloon catheter system (1) according to any one of the preceding claims, wherein the catheter shaft (2) can be inserted into the working channel (64) of the ultrasonic endoscope (60). Method for puncturing tissue (62), in particular in the gastrointestinal tract of a patient, using a medical system claim 11 , having the steps: - Inserting the ultrasonic endoscope (60) into the patient and generating an ultrasonic image of the tissue (62) to be punctured by means of the ultrasonic endoscope (60), - Inserting the puncture needle (63) into the working channel of the ultrasonic endoscope (60) and puncturing of the tissue (62) using the puncture needle (63) and removing the puncture needle (63) from the working channel (64) of the ultrasonic endoscope (60), - placing the first guide wire (51) in the punctured area of the tissue (62) via the puncture needle (63), - removing the puncture needle (63) from the working channel (64) of the ultrasonic endoscope (60) while continuously checking the position of the first guide wire (51), inserting the catheter shaft (2) into the working channel (64) of the ultrasonic endoscope (60). the first guide wire (51) and positioning the balloon (3) in an opening in the tissue (62) produced by the puncture of the tissue (62) and introducing a fluid medium into de n interior (30) of the balloon (3) to widen the opening, - placing the second guide wire (51) in the area of the punctured tissue (62) via the second working channel (22) of the catheter shaft (2) - removing the catheter shaft (2) and deploying a first stent into the opening over the first guidewire (51) and then removing the first guidewire (51) - deploying a second stent into the opening over the second guidewire (52) such that the second stent is adjacent to the first stent in the opening comes to rest.

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