DE102021100034A1 - Procedure and arrangements for the use of biliary stents - Google Patents

Abstract

A stent deployment assembly for use with a guidewire comprising a biliary stent and an elongated stent delivery tube that includes a guidewire retention portion, corresponding distal and proximal openings defining a guidewire path therethrough, and a longitudinally laterally passable portion. In a stent advancement arrangement, the guidewire runs through the respective openings to pass through the guidewire holding section inside, and the stent is arranged so that it surrounds a stent delivery tube section which is proximal to the guidewire holding section for advancing the stent together with the stent delivery tube along the guidewire Is offset body lumen of a human patient. When the stent is arranged in the stent advancing arrangement at a target deployment site within the lumen, retraction of the stent delivery tube in the proximal direction causes the guide wire to pass the laterally passable part of the guide wire holding section in order to decouple the guide wire from the tube without the guide wire in Shift lengthways.

Description

Embodiments of the present invention relate generally to medical devices and, more particularly, to methods and devices for deploying stents in a lumen of a person.

Stents are typically deployed within a lumen of a person's body for a variety of reasons. In some cases, a stent is deployed within a lumen to widen a narrowed portion of the lumen. For example, a biliary stent is inserted into a bile duct to treat obstructions and strictures that occur in the bile duct. There are several malignant or benign conditions that can cause the bile duct to narrow. Pancreatic cancer is a common malignant cause of bile duct narrowing. Non-cancerous causes of bile duct stricture can include an injury to the bile duct that occurs during surgery to remove the gallbladder, as well as pancreatitis.

A biliary stent is typically a tubular device that is used to support a narrowed portion of the bile duct and to inhibit reformation of the stricture. Often a tube or catheter is used to deploy stents. A guide wire is often used to guide the stent to its destination in the lumen. Handling of the guidewire while deploying the stent can break the guidewire and / or have other adverse physical effects on the person. Therefore, there is a need for a reliable method and apparatus for deploying biliary stents without manipulating the guidewire.

A device for use with a guidewire comprising: a. a biliary stent; and b. an elongated stent delivery tube having a guidewire retention portion having (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinally laterally passable portion, wherein: (i) in a stent advancing arrangement (A) the guidewire passes through the respective openings to pass through the guidewire holding portion inside, and (B) the stent is arranged to have a portion of the stent delivery tube, which is offset proximal to the guidewire holding portion, for pushing the stent together with the Surrounding the stent delivery tube along the guidewire into a body lumen of a person, and (ii) when the stent in the stent delivery assembly is deployed at a target deployment site within the lumen, retraction of the stent delivery tube in the proximal direction causes the guidewire to cross the laterally passable portion of the guide wire holding portion happens so that the guide wire is decoupled from the tube without it being displaced in the longitudinal direction.

In some embodiments, the stent in the stent delivery assembly is the only stent that is deployed with the guidewire.

In some embodiments, the device includes only a single stent, which is the biliary stent.

In some embodiments, the device is provided as an assembled arrangement such that (i) the single biliary stent is mounted on the stent delivery tube; and (ii) only the single biliary stent with the stent delivery tube is inserted.

Some embodiments (e.g., provided in the stent delivery assembly and) further include the guidewire that engages and is in contact with the individual biliary stent.

In some embodiments, the guidewire in the stent delivery assembly does not internally traverse the portion of tubing surrounded by the stent.

In some embodiments, both the individual biliary stent and the stent delivery tube mounted thereon are arranged in a common container, the container being closed.

In some embodiments, no other stent than the biliary stent is arranged in the common container.

Some embodiments are provided in a kit form so that the single biliary stent is not mounted on the stent delivery tube, with both the individual biliary stent and the stent delivery tube being in a common and closed container and no other stent in the container.

In some embodiments, the common container is a bag.

In some embodiments, an interior of the common container is sterile or pre-sterilized.

In some embodiments, the common container is sealed.

Some embodiments are provided in kit form such that the stent delivery tube is placed in a closed container without a stent attached, the interior thereof being sterile or sterilized.

Some embodiments are provided in a kit form so that the single biliary stent is not mounted on the stent delivery tube, the biliary and stent delivery tubes being arranged in each closed container that is mechanically connected to one another and no other stent is mechanically connected to one the container is inserted.

In some embodiments, in which several different slots are arranged in the longitudinal direction along the guide wire holding section (cf. 2 B) , the slots are spaced apart from one another in the longitudinal direction, so that the slot and non-slot sections of the guide wire holding section alternate in the longitudinal direction.

In some embodiments, in which several different pre-weakened sections are arranged in the longitudinal direction along the guide wire holding section (cf. 2 B) , the pre-weakened sections are spaced apart from one another in the longitudinal direction, so that the pre-weakened sections and non-pre-weakened sections of the guide wire holding section alternate in the longitudinal direction.

In some embodiments, in which several different, thinner hose wall sections are arranged in the longitudinal direction along the guide wire holding section (cf. 2 B) , the thinner tube wall sections are spaced apart from one another in the longitudinal direction, so that the thinner tube wall sections and sections in which the tube wall of the guide wire holding section is thicker alternate in the longitudinal direction.

In some embodiments, a retraction of the stent delivery tube in the proximal direction causes the guide wire to pass the laterally passable section of the guide wire holding section, whereby by applying a first proximal retraction force of at least 100 g and not more than 20 kg or at least 500 g and not more than 10 kg or at least 1 kg and not more than 5 kg or at least 1.5 kg and not more than 2.5 kg.

In some embodiments, after the guide wire has laterally passed the laterally passable section of the guide wire holding section, a second proximal retraction force that is less than the first proximal retraction force can cause the stent delivery tube to be retracted in the proximal direction.

In some embodiments, retraction of the stent delivery tube in the proximal direction is effective to leave the stent deployed in the lumen without manipulation of the guidewire.

In some embodiments, the guidewire in the stent delivery assembly does not internally traverse the portion of tubing surrounded by the stent.

In some embodiments, the laterally passable portion of the guidewire holding portion comprises at least: (i) a slot with opposing slit lips and (b) a perforation and (iii) a thinned tube wall.

In some embodiments, (i) the stent is a first stent and the device additionally comprises a second stent and (ii) in the stent delivery arrangement (A) the second stent is arranged to have a portion of a second stent delivery tube which is proximal to the first stent, surrounds to advance the second stent into the body lumen, and (B) the guide wire passes internally through the second portion of the stent delivery tube.

An assembly process comprising: a. Providing a guidewire, a biliary stent, and a stent delivery tube, the stent delivery tube having a guidewire holding portion and a stent delivery tube portion offset proximally therefrom; b. Placing the biliary stent around the portion of the stent delivery tube; and c. Passing an end portion of a guidewire through respective distal and proximal openings of the guidewire holding portion to pass inside the guidewire holding portion, the guidewire holding portion having a longitudinally laterally-passable portion, the routing through and arranging being effective in combination to achieve an assembled state, in which the stent delivery tube, together with the stent arranged around it, can be advanced in the longitudinal direction along the guide wire, the guide wire holding section being effective to hold the guide wire therein; and wherein the stent insert assembly can be disassembled by anchoring the stent, and wherein with the anchoring of the stent, the stent delivery tube is withdrawn proximally from at least the interior of the stent without manipulating the guide wire, wherein the proximal withdrawal of the tube is effective that the guide wire the laterally vulnerable part of the guide wire holding section happened laterally and thereby decoupled the guide wire from the tube.

In some embodiments, the stent in the stent delivery assembly is the only stent that is deployed with the guidewire.

In some embodiments, upon completion of the procedure, only a single stent, which is the biliary stent mounted on the stent delivery tube, is deployed; and (ii) no other stent other than the single biliary stent is inserted with the stent delivery tube.

In some embodiments, step (b) is performed before step (c).

In some embodiments, step (c) is performed before step (b).

In some embodiments, the retraction of the tube comprises the application of a first proximal retraction force, which causes the guide wire to laterally pass the laterally passable part, the first proximal retraction force at least 100 g and not more than 10 kg or at least 500 g and not more than 5 kg, or at least 1 kg and not more than 2.5 kg, or at least 1.5 kg and not more than 2 kg, and a second proximal retraction force that is less than the first proximal retraction force causes the stent delivery tube after the guide wire has laterally passed through the laterally passable part of the guide wire holding section, the stent delivery tube is withdrawn from the stent.

In some embodiments, in the stent delivery assembly, the guidewire does not pass internally through the tubing section that is surrounded by the stent.

In some embodiments, (i) the stent is a first stent and the stent delivery tube section is a first stent delivery tube section, and (ii) the method additionally comprises: arranging the second stent to a second stent delivery tube section that is offset proximally from the first stent delivery tube section surround; and guiding the proximal end portion of the guidewire through an opening located proximally from the first stent delivery tube section and distal from the second stent delivery tube section so that the guidewire passes internally through the second stent delivery tube section.

In some embodiments (e.g. 2 B) A plurality of different slots are arranged in the longitudinal direction along the guide wire holding section, the slots being spaced apart from one another in the longitudinal direction, so that the slots and non-slot sections of the guide wire holding section alternate in the longitudinal direction.

In some embodiments (see e.g. 2 B) A plurality of different pre-weakened sections are arranged in the longitudinal direction along the guide wire holding section, the pre-weakened sections being spaced apart from one another in the longitudinal direction, so that the pre-weakened sections and non-pre-weakened sections of the guide wire holding section alternate in the longitudinal direction.

In accordance with the embodiments disclosed herein, a stent deployment assembly for use with a guidewire comprises: (a) a biliary stent, and (b) an elongated stent delivery tube that includes a guidewire retention portion that includes (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) defining a longitudinally laterally passable portion, the arrangement being characterized as follows: (i) in a stent delivery arrangement, (A) the guidewire extends through the respective openings to pass internally through the guidewire holding portion, and (B) the stent is arranged so that it surrounds a portion of the stent delivery tube that is offset proximally from the guidewire holding portion in order to advance the stent together with the stent delivery tube along the guide wire into a body lumen of a human person, and (ii) when the stent is in the stent advancement Arrangement at a target location within of the lumen is used, the stent delivery tube is withdrawn in the proximal direction, so that the guide wire passes the laterally passable part of the guide wire holding section in order to decouple the guide wire from the tube without longitudinal displacement of the guide wire.

In some embodiments, when the device is advanced along the guidewire into the stent delivery assembly, the guidewire retention portion may cause the guidewire to be retained therein.

In some embodiments, in the stent delivery arrangement, the guidewire may not internally pass through the tubing section surrounded by the stent.

In some embodiments, a section of the stent delivery tube that is proximally adjacent to the guide tube holding section may have a smaller diameter than the guide tube holding section.

In some embodiments, the distal opening of the guide wire holding portion may point in the distal direction and the proximal opening may point in the proximal direction.

In some embodiments, the assembly may additionally include a proximally retractable locking mechanism that acts to maintain a position of the stent relative to the tube as the assembly is advanced along the guidewire in the stent advancement assembly.

In some embodiments, it may be that a retraction of the stent delivery tube in the proximal direction causes the guide wire to pass the laterally passable part of the guide wire holding section, which, by applying a first proximal retraction force of at least 100 g and not more than 20 kg, or at least 500 g and not more than 10 kg, or at least 1 kg and not more than 5 kg, or at least 1.5 kg and not more than 2.5 kg. In some embodiments, it can be the case that a retraction of the stent delivery tube in the proximal direction after the guide wire has laterally passed the laterally passable part of the guide wire holding section by a second retraction force which is less than the first retraction force. In some embodiments, retraction of the stent delivery tube in the proximal direction after the guide wire has laterally passed the laterally passable portion of the guide wire holding portion may cause the stent to be left unfolded in the lumen without manipulation of the guide wire.

In some embodiments, the laterally passable portion of the guidewire retaining portion may include a slot portion having opposing slot lips that are either in contact with one another or are offset from one another by no more than a diameter of the guidewire. In some embodiments, the laterally passable portion of the guidewire holding portion may comprise a perforated and / or thinned tubing wall portion.

In some embodiments, the assembly can additionally include the guidewire.

In some embodiments in the stent delivery assembly, the stent may be the only stent deployed with the guidewire.

In some embodiments, it may be that (i) the stent is a first stent and the arrangement additionally comprises a second stent, and (ii) in the stent advancement arrangement the second stent is arranged that it has a second stent delivery tube section that is proximal to the first stent is offset to advance the second stent into the body lumen. In some of these embodiments, the guidewire in the stent delivery assembly may internally traverse the second stent delivery tube section. In some of these embodiments, when the second stent is placed at a second target location along the deployed first stent, retraction in the proximal direction of the stent delivery tube and guidewire may cause the stent to deploy in the lumen without further manipulation of the guidewire is left behind.

In accordance with the embodiments disclosed herein, a stent deployment assembly for use with a guidewire comprises: (a) an embodiment forming elongated stent delivery tube that includes a guidewire retention portion that has (i) a longitudinally laterally passable portion that (ii) is configured for the guidewire runs through there; and (b) a biliary stent arranged to surround a portion of the stent delivery tube that is offset proximally from the guidewire holding portion to advance the stent along with the stent delivery tube along the guide wire into a body lumen of a human person. The device is characterized as follows: when the stent is deployed at a target location within the lumen, the stent delivery tube is withdrawn in the proximal direction so that the guide wire passes the laterally passable part of the guide wire holding section in order to remove the guide wire from the tube without manipulation of the guidewire.

In some embodiments, when the device is advanced along the guidewire into the stent delivery assembly, the guidewire retention portion may cause the guidewire to be retained therein.

In some embodiments, in the stent delivery arrangement, the guidewire may not internally pass through the tubing section surrounded by the stent.

In some embodiments, a section of the stent delivery tube that is proximally adjacent to the guide tube holding section may have a smaller diameter than the guide tube holding section.

In some embodiments, the assembly may additionally include a proximally retractable locking mechanism that acts to maintain a position of the stent relative to the tube as the assembly is advanced along the guidewire in the stent advancement assembly.

In some embodiments, it can be that a retraction of the stent delivery tube in the proximal direction causes the guide wire to pass the laterally passable part of the guide wire holding section, which is achieved by applying a first proximal retraction force of at least 100 g and not more than 20 kg, or at least 500 g and not more than 10 kg, or at least 1 kg and not more than 5 kg, or at least 1.5 kg and not more than 2.5 kg. In some embodiments, it can be the case that a retraction of the stent delivery tube in the proximal direction after the guide wire has laterally passed the laterally passable part of the guide wire holding section by a second retraction force which is less than the first retraction force.

In some embodiments, retraction of the stent delivery tube in the proximal direction after the guide wire has laterally passed the laterally passable portion of the guide wire holding portion may cause the stent to be left unfolded in the lumen without manipulation of the guide wire.

In some embodiments, the laterally passable portion of the guidewire retaining portion may include a slot portion having opposing slot lips that are either in contact with one another or are offset from one another by no more than a diameter of the guidewire. In some embodiments, the laterally passable portion of the guidewire holding portion may comprise a perforated and / or thinned tubing wall portion.

In some embodiments, the assembly can additionally include the guidewire.

In some embodiments, in the stent delivery assembly, the stent may be the only stent deployed with the guidewire. In some embodiments, it may be that (i) the stent is a first stent and the arrangement additionally comprises a second stent, and (ii) in the stent advancement arrangement the second stent is arranged that it has a second stent delivery tube section that is proximal to the first stent is offset to advance the second stent into the body lumen. In some of these embodiments, the guidewire in the stent delivery assembly may internally traverse the second stent delivery tube section. In some of these embodiments, when the second stent is placed at a second target location along the deployed first stent, retraction in the proximal direction of the stent delivery tube and guidewire may cause the stent to deploy in the lumen without further manipulation of the guidewire is left behind.

• einen Stentförderabschnitt, der konfiguriert ist, dass ein Gallenstent um ihn herum zum Vorschieben entlang eines Führungsdrahts in den Lumen montiert ist; und
• einen Führungsdrahthalteabschnitt, der distal von dem Stentförderabschnitt versetzt ist, wobei der Führungsdrahthalteabschnitt folgendes umfasst: (i) entsprechende distale und proximale Öffnungen, die einen Führungsdrahtweg dort hindurch definieren, und (ii) einen längsgerichteten, seitlich-passierbaren Teil,
• wobei der seitlich-passierbare Teil des Führungsdrahthalteabschnitts (i) einen Schlitzabschnitt aufweist, der einander gegenüberliegende Schlitzlippen, die im Wesentlichen miteinander in Kontakt stehen und/oder (ii) einen perforierten und/ oder verdünnten Schlauchwandabschnitt aufweist.

An elongated stent delivery tube for guidewire-assisted deployment of a biliary stent in a lumen of a human body, the tube comprising:

• a stent delivery section configured to have a biliary stent mounted around it for advancement along a guide wire into the lumen; and
• a guidewire holding section offset distally from the stent delivery section, the guidewire holding section comprising: (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinal, laterally-passable portion,
• wherein the laterally passable part of the guide wire holding section (i) has a slit section which has mutually opposite slit lips which are substantially in contact with each other and / or (ii) a perforated and / or thinned tube wall section.

In some embodiments, the tube is placed in a container (e.g., sealed and / or with a sterilized interior) (e.g., a pouch) with no additional stent placed in the container along with the elongated stent delivery tube for guidewire-assisted deployment.

In accordance with the embodiments disclosed herein, an elongated stent delivery tube for guidewire-assisted deployment of a biliary stent in a lumen of a human body comprises: (a) a stent delivery section configured to have a biliary stent mounted around it for advancement along a guidewire in the lumen; and (b) a guidewire retention section offset distally from the stent delivery section, the guidewire retention section comprising: (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinal, laterally passable portion, wherein the laterally passable part of the guide wire holding section (i) has a slit section which has mutually opposite slit lips which are essentially in contact with each other and / or (ii) has a perforated and / or thinned tube wall section.

A method is disclosed in accordance with the embodiments for deploying a biliary stent in a lumen of a human body using a guide wire such as this is arranged that a distal end portion thereof is arranged inside the body lumen and a proximal end portion thereof is arranged outside the body. The method comprises: (a) passing the proximal end portion of the guidewire through corresponding distal and proximal openings of a guidewire holding portion of a distal portion of a stent delivery tube so as to traverse the guidewire holding portion internally, the guidewire holding portion having a longitudinally laterally passable portion; (b) placing a biliary stent around a stent delivery tube section offset proximally from the guidewire holding section; (c) advancing the stent delivery tube distally along the guidewire along with the stent disposed therearound such that the stent is delivered to a stent deployment target within the body lumen; and (d) proximally retracting the stent delivery tube from at least the interior of the stent so as to deploy the stent in the lumen without retracting the guidewire proximally or advancing distally, the proximal retraction of the tube causing the guidewire laterally to be laterally passable Passed section of the guide wire holding section and thereby decoupled the guide wire from the tube.

In some embodiments, the placement of the stent can be accomplished after the guidewire has been passed through the respective openings. In some embodiments, the stent may be deployed prior to guiding the guidewire through the respective openings.

In some embodiments, the arranging steps may be performed in a factory and all subsequent steps may be performed in a medical school.

In some embodiments, retraction of the tube in the proximal direction may include the application of a first proximal retraction force in order to cause the guide wire to laterally pass the laterally passable part of the guide wire holding portion, the first proximal retraction force at least 100 g and not more than 10 kg, or at least 500 g and not more than 5 kg, or at least 1 kg and not more than 2.5 kg, or at least 1.5 kg and not more than 2 kg, or at least 1.5 kg and not is more than 2.5 kg. In some of these embodiments, it may be that a second proximal retraction force, which is less than the first proximal retraction force, causes the stent delivery tube to be withdrawn from the stent after the guide wire has laterally passed through the laterally passable part of the guide wire holding section. In some of these embodiments, the placement of the biliary stent may include connection to a locking mechanism to couple the stent to the stent delivery tube.

In some embodiments, prior to the proximal withdrawal of the stent delivery tube, the method additionally comprises: releasing the locking mechanism.

In some embodiments, a section of the stent delivery tube that is proximally adjacent to the guide tube holding section may have a smaller diameter than the guide tube holding section.

In some embodiments, in the stent delivery arrangement, the guidewire may not internally traverse the tubing section that is surrounded by the stent.

In some embodiments, the stent may be deployed in the lumen without manipulating the guidewire.

• 1 ist eine schematische Darstellung eines distalen Abschnitts eines Stentförderschlauchs, eingelegt mit einem Führungsdraht, in Übereinstimmung mit Ausführungsformen der vorliegenden Erfindung.
• 2A und 2B sind schematische Darstellungen einer Stentanordnung und seiner Entfaltung in einem Lumen einer menschlichen Person, in Übereinstimmung mit Ausführungsformen der vorliegenden Erfindung.
• 3 zeigt ein Flussdiagramm eines Verfahrens zum Einsatz eines Gallenstents in einem Lumen einer menschlichen Person in Übereinstimmung mit der vorliegenden Erfindung.
• 4A, 4B und 4D sind schematische Darstellungen, die einen allgemeinen Überblick eines Verfahrens zum Einsatz eines Stents in einem Lumen einer Person in Übereinstimmung mit Ausführungsformen der vorliegenden Erfindung darstellen.
• 4C ist eine schematische Darstellung eines distalen Abschnitts eines Stentförderschlauchs, gezeigt in Verbindung mit einem Führungsdraht während des proximalen Zurückziehens eines Stentförderschlauchs, in Übereinstimmung mit der vorliegenden Erfindung.
• 5 zeigt ein Flussdiagramm eines Verfahrens zum Einsatzvon mehreren Stents in einem Lumen einer menschlichen Person, in Übereinstimmung mit Ausführungsformen der vorliegenden Erfindung.
• 6A bis 6E sind schematische Darstellungen, die einen generellen Überblick eines Verfahrens zum Einsatzmehrerer Stents in einem Lumen einer Person in Übereinstimmung mit Ausführungsformen der vorliegenden Erfindung darstellen.
• 7A bis 7B sind schematische Darstellungen eines Verschlussmechanismus, der einen Verschluss umfasst, der konfiguriert ist, um eine Bewegung des ersten Stents in Bezug auf den Führungsschlauch zu verhindern.
• 8A bis 8D sind schematische Darstellungen von Verschlussmechanismen, die erste und zweiten Verschlüsse umfassen, die konfiguriert sind, um eine Bewegung des ersten Stents beziehungsweise des zweiten Stents in Bezug auf den Führungsschlauch zu verhindern.

In some embodiments, (i) the stent is a first stent and the stent delivery tube section is a first stent delivery tube section, and (ii) the method additionally comprises: placing a second stent around a second stent delivery tube section proximal to the first stent delivery tube section is offset to surround; Passing the proximal end portion of the guide wire through an opening located proximally from the first stent delivery tube section and distal from the second stent delivery tube section so that the guide wire passes through the second stent delivery tube section; then, proximally withdrawing the stent delivery tube from at least the interior of the first stent to deploy the first stent in the lumen, (i) distally advancing the second stent along the stent delivery tube, and (ii) distally advancing the stent delivery tube along the guidewire together with the second Stent disposed therearound so as to deliver the second stent to a second stent deployment target along the first stent; and proximally withdrawing the stent delivery tube and guidewire from at least the interior of the second stent so as to deploy the second stent in the lumen without tampering with the guidewire.

• 1 Figure 3 is a schematic representation of a distal portion of a stent delivery tube deployed with a guidewire in accordance with embodiments of the present invention.
• 2A and 2 B Figure 13 are schematic representations of a stent assembly and its deployment in a lumen of a human person, in accordance with embodiments of the present invention.
• 3 Figure 3 shows a flow diagram of a method for deploying a biliary stent in a lumen of a human person in accordance with the present invention.
• 4A , 4B and 4D Figure 13 are schematic representations depicting a general overview of a method of deploying a stent into a lumen of a person in accordance with embodiments of the present invention.
• 4C Figure 3 is a schematic illustration of a distal portion of a stent delivery tube shown in connection with a guidewire during proximal retraction of a stent delivery tube in accordance with the present invention.
• 5 Figure 3 shows a flow diagram of a method for deploying multiple stents in a lumen of a human person, in accordance with embodiments of the present invention.
• 6A to 6E Fig. 13 are schematic representations depicting a general overview of a method of deploying multiple stents into a lumen of a person in accordance with embodiments of the present invention.
• 7A to 7B Fig. 13 are schematic representations of an occlusion mechanism including an occlusion configured to prevent movement of the first stent with respect to the guiding tube.
• 8A to 8D Figure 12 are schematic representations of occlusion mechanisms including first and second closures configured to prevent movement of the first stent and the second stent, respectively, with respect to the guiding tube.

In accordance with embodiments, a stent assembly includes a biliary stent attached to a catheter tube suitable for delivering the stent to a target deployment site within a lumen of a human person, for example, to maintain the flow viability of a bile duct. The assembly is configured to be advanced along a guidewire that is normally inserted into the person's body prior to deployment of the stent. A distal end of the guidewire is located within the target lumen and the proximal end remains outside the body. When using short wire systems, the guide wire can be locked externally. The terms “distal” and “proximal” are used in this disclosure and the appended claims as follows: “Distal” means from a point of entry into the body further into the body (along an insertion path), while “proximal” means closer to the point of entry in the body means. When the terms are used in relation to devices outside a patient's body, a distal portion or end is that portion or end of the device that is configured to be inserted into the body first, while a proximal end or end is the proximal part is either inserted last or never (as in the case of a guide wire, for example). In addition, when used relatively, the meaning is, e.g. "Distally offset from" or "proximal from" "closer to the distal end than" or "closer to the proximal end than".

As will be further described below and in the accompanying figures, a catheter tube (alternatively equivalent to "guide tube", "stent delivery tube" or simply "tube") is disclosed which is used to transport the stent to or near a distal tip, engaging arrangements having a guide wire. Openings are provided at each end of a longitudinal guidewire or a guidewire holding portion of the tube, and the guidewire can be threaded through these openings to pass through the interior of the guidewire holding portion of the tube. The guide wire does not pass through the tube section proximal to the guide wire section on the inside and thus “leaves” the interior of the tube at least temporarily at the proximal opening. The distal opening can be at the distal tip of the tube or offset proximally from the tip. It is preferred that the distal opening points distally, i.e., facing distally. H. points in a direction in which the distal tip is pointing, within 15 ° of that direction, or within 30 ° of that direction, or within 45 ° of that direction. The proximal opening preferably points proximally, ie in a direction opposite to the direction in which the distal tip is pointing, or within 15 ° of this "opposite" direction, or within 30 ° or within 45 ° of this "opposite" direction. Direction. Thus, as the guidewire exits the proximal opening, it is routed to continue along the tube (and along the stent surrounding the tube) proximal to the proximal opening.

When the guide wire extends through the interior of the guide wire holding portion, the tube can be advanced lengthwise on the guide wire with low resistance, for example through a additional stent, which is inserted with the guide wire, or it can be pushed forward by a “pusher” catheter, which is inserted with the guide wire. The stent can be assembled to the tubing before or after the tubing is engaged with the guidewire to surround a portion of the tubing that is proximal to the guidewire holding portion. A gap may exist between the guide wire holding portion and the stalk holding portion.

The arrangement in which the stent is mounted on the tube so that it surrounds a portion which is located proximal to the guide wire holding section and in which the tube with the guide wire is inserted by the guide wire passing through the interior of the guide wire holding section is described here referred to as the "stent advancement assembly" of the stent assembly.

The guidewire retention portion is configured to retain the guidewire therein during advancement of the stent into the body lumen in the stent advancement assembly. In some embodiments, the relative longitudinal stability of the position of the stent relative to the tube is achieved using an occluding stent, as discussed below. The guide wire holding portion has a longitudinally laterally passable portion whereby the guide wire holding portion becomes laterally passable by the guide wire. The guidewire holding portion of the tube is designed so that when a shear force is applied it will pass the side of the guidewire, starting at the proximal opening when the tube is "unlocked" proximally after the stent has been deployed and anchored in the lumen (and any locking system) is withdrawn. The laterally passable portion may be a weakened or pre-broken sidewall of the guidewire holding portion, as described below with respect to FIG 1 and 2A-2B will be explained in more detail.

Once the stent has reached a target location for stent deployment in the lumen of the patient's body, e.g. B. the bile duct, the stent delivery tube can be withdrawn proximally to leave the stent deployed in the lumen. The stent is preferably self-anchoring, with one or more anchor tabs maintaining the position of the stent against the force used to retract the tube so that the stent slides off the distal end of the tube. As soon as the proximal opening of the guide wire holding section reaches the edge of the stent, the guide wire emerging from the proximal opening is clamped against the proximal opening by the immovable stent, and the resulting shear force causes the guide wire to pass the laterally passable part of the stent. The continued application of the force has the effect that the guide wire leaves the passable guide wire holding section laterally and is thus released or decoupled from it. The force required to break through the laterally passable part of the guide wire holding portion can be at least 100 g and not more than 20 kg. In various embodiments, the force required can be at least 500 g and not more than 10 kg, or at least 1 kg and not more than 5 kg, or at least 1.5 kg and not more than 2.5 kg. Once the guidewire holding section has been completely passed, the force required to withdraw the tube from the anchored stent may be less than the force required to pass the guidewire holding section.

We now refer to the figures and in particular to 1 which is a schematic representation of a distal portion of a stent delivery tube 220 according to a non-limiting example. The hose 220 is elongated in such a way that it is many times longer (e.g. 100 times or 200 times or more) than thick. The hose 220 stands with the distal end of a guidewire 12th engaged to some of the characteristics of the hose 220 and the way in which he used the guidewire 12th is inserted to illustrate. Distal and proximal directions in relation to the tube and the stent are indicated by arrows 1001 displayed.

As in 1 shown is a first distal section 222 through a distal opening 320 and a proximal opening 262 delimited. In some embodiments, the distal opening is not necessarily located at the distal tip (the tip of the distal portion of the tube 220 ), but is offset proximally from it. In such embodiments, the distal opening is pointing 320 preferably distally or within 15 ° or 30 ° or 45 ° of the distal direction. Similarly shows the proximal opening 262 preferably proximally, as in 1 is shown, or within 15 ° or 30 ° or 45 ° of the proximal direction. A main purpose of engaging the hose 220 into the guide wire 12th is a distal advancement of the tube along with one or more through the tube 220 to enable the delivered stent to a target location for stent deployment within a lumen of a person's body; therefore, it may be desirable that the guidewire-inlaid portion of the tube (with the guidewire inlaid) traverse the length of the guidewire with a minimum of resistance and appropriate angling of the openings 320 , 262 can help reduce drag from friction and other forces. The one with the guide wire in Engaging standing section 222 Also referred to in this disclosure as the guidewire retention section, as the section is configured to hold the guidewire therein as the tubing traverses the guidewire. The guidewire holding section 222 comprises a laterally passable part in the longitudinal direction 278 that is configured to attach it to the restrained guidewire 12th to enable the guidewire holding portion 222 to pass sideways when an appropriate shear force is applied, as discussed in more detail below.

In 1 can be seen that a section 232 near the guide wire holding portion 222 has a diameter less than that of the guidewire holding portion, and it is easy to understand that the difference in diameters is the use of a simple design for the proximal opening 262 enabled, ie formed so that it points in the proximal direction, as in the example of FIG 1 . In other examples of a stent delivery tube 222 According to embodiments (not shown), the diameter of the proximal section 232 equal to or larger than the diameter of the guide wire holding portion 222 be, and the proximal opening 262 can be positioned and angled accordingly. In either case, the guide wire will settle 12th after exiting the guide wire holding section 222 via the proximal opening proximally outside the tube 222 and go through the next section 232 not inside.

Referring to the 2A and 2 B are examples for configuring the distal end of a stent assembly 101 shown schematically. The stent assembly 101 includes the stent delivery tube 220 of 1 along with a biliary stent 52 that on the hose 220 attached to a section of hose 220 to surround. In some embodiments, the stent assembly additionally comprises the guide wire 12th . The stent 52 is proximal of the guidewire holding portion 222 offsets and does not necessarily adjoin the guidewire holding portion 222 on, ie in the example shown there is an intermediate section 232 , as in 1 will be shown. As in the 2A and 2 B shown, the guidewire extends 12th after leaving the proximal opening 262 proximally outside the tube 220 and sits proximally next to the stent 52 away.

The differences between the examples of 2A and 2 B consist in the specific cross-sectional construction of the section 232 (and from more proximal sections of the tubing 220 ) and in the specific construction of the laterally passable part 278 .

Regarding the cross section of the section 232 is in the in 2A The example shown is the cross-section of the hose 220 at the section 232 (as in detail box 98 shown) open and U-shaped. In other words, proximal to the guidewire holding portion 222 the hose does not have to be a complete cylinder. The respective section of the hose can be formed with an open U-shape or can be a collapsed or crushed section of a completely cylindrical section. Using the U-shape can be helpful in some constructions to help route the guidewire 12th when leaving the proximal opening 262 to facilitate. In contrast, for example, to the U-shape of 2A is the cross section of the hose 220 at the section 232 a full circle in the example shown in Figure 2B, ie the hose 220 is in section 232 shaped as a complete cylinder. The section of hose 220 that of the stent 52 can also use a cross-section and can easily make the design selection of the intermediate section 232 continue. None of the sections are limited to the specific designs presented in the non-limiting examples of FIG 1 and 2 are shown. 2A and 2B, and any cross-sectional construction can be used.

With regard to the construction of the side-passable part 278 of the guide wire holding portion 232 , shows the first of the two in 2A with A1 designated cross-sectional detail boxes that the laterally passable part 278 a slot 280 may have, which is shaped so that it has two "lips" 282 ("Slit lips") which are in contact with one another or in contact with one another proximally, but are no further apart than the diameter of the guide wire 12th to define a closed slot arrangement when there are no forces acting on the slot lips 282 be exercised. The slit lips 282 are displaceable from one another, typically by the appropriate application of a force to effect the displacement to define a slot open arrangement. The second of the two cross-section detail boxes shown in 2A denoted by A1 shows that the laterally passable part 278 a weakened sidewall portion 284 may contain that through the guidewire 12th is cleavable / passable in response to an appropriately applied force. A third example of a construction of the side-passable part 278 is in the detail box in 2 B shown, in which it is shown that the laterally passable part 278 perforated and thus through the guide wire 12th force applied in response to an appropriate part is fissile / passable. The construction of the laterally passable part 278 is not limited to the specific constructions shown in the non-limiting examples of FIG 2A and 2 B are shown and each functionally equivalent construction, which in a suitable manner, the lateral breakthrough of the guide wire holding portion 222 enables can be used.

One or more anchor tabs 522 are on the outer surface of the stent 52 trained so that when the stent 52 is deployed at a target site within a lumen of the person, one or more anchoring tabs are effective to anchor the stent in place by hooking or hanging onto the inner wall of the lumen.

With reference to 3 discloses a method for deploying a biliary stent in a lumen of a human body. As shown by the flowchart in 3 as shown, the method comprises: step S01, guiding an end, e.g. B. a proximal end of the guide wire 12th through the guide wire holding portion 222 of the stent delivery tube 220 via the respective distal and proximal openings 320 , 262 ; and

Step S02 placing the stent 52 on the stent delivery tube 220 proximal to the guidewire holding section 222 . As previously mentioned, an additional section can be added 232 between the guide wire holding portion 222 and the tube section on which the stent 52 is mounted, lie.

As shown in the flowchart, steps S01 and S02 can be carried out in any order, ie first step S01 and then step S02 or first step S02 and then step S01. As an example, it may be desirable to use the hose 220 with the guide wire 12th to connect before the stent 52 on the hose 220 is mounted. As another example, it may be desirable to have the stent 52 in the hose 220 to place before the hose 220 with the guide wire 12th is inserted.

After carrying out steps S01 and S02, you can see how the stent arrangement has changed 101 in a "stent advancement arrangement" in which the guidewire 12th through the distal and proximal openings 320 , 262 extends to traverse the guidewire holding portion inside and how the stent 52 is arranged to surround a stent delivery tube section proximal of the guidewire holding section 222 is offset to the stent 52 together with the stent delivery tube 220 along the guide wire 12th advance into a body lumen of a human person.

• Schritt S03 Vorschieben des Stentförderschlauchs 220 entlang des Führungsdrahts 12 zusammen mit dem Stent 12, d. h. mit dem Führungsdrahthalteabschnitt 222, der mit dem Führungsdraht 12 eingelegt ist, um den Stent 52 an einen Zielort in einem Lumen, z. B. einem Gallenkanal eines Patienten zu befördern; und

The procedure also includes:

• Step S03 advancing the stent delivery tube 220 along the guide wire 12th along with the stent 12th , that is, with the guide wire holding portion 222 , the one with the guide wire 12th is inserted to the stent 52 to a target location in a lumen, e.g. B. to convey a biliary duct of a patient; and

Step S04 pulls the stent delivery tube 220 proximally to deploy the stent in the lumen without manipulating the guidewire. The term “without manipulating the guide wire” describes a situation in which the stent 52 through one or more anchoring straps 522 anchored and substantially immobilized in the lumen (e.g., does not move more than 1 mm, or more than 2 mm, or more than 3 mm, or more than 5 mm, or more than 10 mm longitudinally) to withstand longitudinal forces that with the retraction of the stent delivery tube 220 are inserted.

Steps of the present method for deploying a biliary stent in a lumen of a human body using a stent assembly 101 in accordance with embodiments of the present invention are described in connection with 4A-C explained in more detail.

shows schematically a stent arrangement 101 , for example one of the stent arrays 101 the 2A-2B when the stent arrives 52 at a target location while the stent assembly is underway 101 still in the above-mentioned “stent advancement arrangement” in a lumen 4th of a patient. Regarding the procedural steps described in the previous paragraphs are 2A-2B “Snapshots” of a stent arrangement 101 after executing steps S01 and S02 and 4A is a snapshot after executing step S03.

In the specific example of the in 4A shown stent arrangement 101 the hose section has 232 proximal to the guidewire holding section 222 the in 2A shown cross-section of the "squeezed U-shape" and uses the slot 280 / "Slit lips" 282 - Design option for the laterally passable part 278 of the guide wire holding portion 222 , as well as in 2A shown. The selection of this design example in the 4A-4B is for convenience only and each of the design options 2A-2B or their functional equivalents can be used for the same benefit.

In contrast to the illustrations of the 2A-2B shows 4A the proximal end of the stent 52 and shows the guide wire 12th going through the opening 400 back into the interior of the stent delivery tube 220 entry. During this Arrangement is optional, it may be desirable to use the guidewire 12th behind (ie proximal) the stent 52 to engage again in the stent delivery assembly. As a non-limiting example, this arrangement can simplify the control of the guidewire and the stent delivery tube both during the advancement of the stent and during the subsequent retraction of the tube and / or the guidewire. Passing the guide wire through 12th also limits the ability of the stent 52 on, during the stent advancement step S03 with respect to the tube 220 to slip proximally. In addition, as discussed below, the use of the assembly may be advantageous when it is desired to deliver a second stent along with (ie, immediately or shortly after and adjacent to) the delivery of the "first" stent.

We are now referring to that 4B and 4C which schematically illustrate the dynamics of step S04. Step S04 is preferably performed after the stent placement 101 along the guide wire 12th was advanced until the stent 52 is located at a target location, such as one that may have been selected in advance or one that can be viewed using an endoscope, which is passed along the guide wire 12th or another guidewire inserted. In step S04, the stent delivery tube 220 withdrawn proximally, ie in the direction of the arrow 1002 the 4B and 4C . The stent 52 is configured, as mentioned above, to be supported by an anchoring tab 522 in a wall of lumens 4th anchored or at least prevented from moving more than 1 mm, or more than 2 mm, or more than 3 mm or more than 5 mm proximally. As in 4C shown causes the movement of the stent delivery tube 220 in the proximal direction that the opening is 262 through which the guide wire 12th from the guide wire holding section 222 emerges, the distal end of the stent 52 approaching. This approach causes a shear force (shown schematically by the arrow 1005 ) on the section of the guide wire 12th proximal to the opening 262 and finally to the section of guidewire 12th distal to the opening 262 hits. When the force that is applied to the stent delivery tube 220 Withdrawing proximally, in a suitable range or alternatively / equivalently above a minimum required force level, brings about the shear force that is present at the opening 262 begins the guide wire 12th in addition, the laterally passable part 278 of the guide wire holding portion 222 to happen. Appropriate ranges of force to be applied to the hose 220 retract proximally to the laterally passable part 278 Break through include: at least 100 g and not more than 20 kg, or at least 500 g and not more than 10 kg, or at least 1 kg and not more than 5 kg, or at least 1.5 kg and not more than 2.5 kg. Once the side wall of the hose 220 in the guide wire holding section 222 , ie the laterally passable part, has been passed, the guide wire leaves 12th the guide wire holding portion 222 laterally and thus decouples or detaches from the hose 220 . The passage is shown in the three cross-sectional detail boxes from 4B , which each represent a point in time, are shown as follows: The guide wire is located in the leftmost detail box 12th still inside the guide wire holding section 222 ; in the middle box you can see that the guide wire 12th actively passes the side passable part; and in the rightmost detail box is the guide wire 12th that has emerged laterally thereof, outside of the guide wire holding portion 222 to see.

Thus, in 4D to see that the stent delivery tube 220 has been withdrawn proximally at least to the extent that its distal tip is no longer distal from the distal end of the stent 52 and the stent 52 Note that the force that is required to move the stent delivery tube is offset 220 after detaching from the guide wire 12th to withdraw further, may be less than the force required to pass the laterally passable part 278 of the guide wire holding portion 222 is required. Insertion of the stent 52 into the lumen 4th using the disclosed method and stent assembly 101 can be performed without the guide wire 12th manipulate in order to "detach" or decouple the hose from it. In particular, there is no need to move the guide wire distally or proximally 12th to cause to perform the procedure. Accidental movement of the guidewire 12th may be during or after step 04, for example by accidental contact or friction with the retracting tube 220 although such movement is not essential and does not detract from the scope of the invention, eliminating the need for directional movement or manipulation of the guidewire 12th excludes.

In some embodiments, the guidewire 12th be left in place for use with other surgical or diagnostic instruments and tools.

In some embodiments, the stent is 52 when together with the stent delivery tube 220 along the guide wire 12th to the destination in the lumen 4th is advanced, the only stent that is attached to the guidewire 12th is inserted, meaning there are no other stents with the guide wire between the stent 52 and the proximal end of the guidewire 12th are engaged.

According to embodiments, it may be desirable to deploy more than one stent in the lumen, for example when more than one stent is required to fully support an obstructed passageway in a channel. It may be that two, three or even more biliary stents are mainly used next to each other in the same lumen and in approximately the same part of the lumen. The stents can all be of the same size or of different sizes. In some cases, a surgeon can predict exactly how many stents (and what sizes) to deploy in advance, and in some cases, after deploying one stent or deploying two or more stents, there may be a need to insert another stent.

The deployment of multiple stents in accordance with the present invention can be handled using various methods.

In a first multiple stent deployment method, the above disclosed method of deploying a single stent using the stent delivery tube can be used 220 (as described in steps S01 .. S04) are repeated. Once the stent delivery tube 220 has been fully withdrawn and the guidewire 220 in accordance with the disclosed embodiments, leaves an additional stent assembly 101 putting one on a stent delivery tube 220 mounted stent 52 includes, along the guidewire 12th to a destination in the lumen 4th , ie in addition to the first stent that has already been inserted 52 advanced. The procedure can be repeated as often as necessary.

• Schritte S01 und S02, wie oben beschrieben, in beliebiger Reihenfolge;
• Schritt S05 Führen des Führungsdrahts durch den Schlauchabschnitt, auf dem der zweite Stent montiert ist oder montiert werden soll. Der Führungsdraht 12 tritt vorzugsweise durch die Öffnung 400 in das Innere des Schlauchs 220 ein / wieder ein, wie in den 4A-4D; und
• Schritt S06 Anordnen des zweiten Stents 54, um einen Abschnitt des Schlauchs proximal zum ersten Stent 52 zu umgeben. In Ausführungsformen gibt es einen Zwischenspalt zwischen dem ersten und dem zweiten montierten Stent, um beispielsweise dem Führungsdraht 12 zu ermöglichen, durch die Öffnung 400 in das Innere des Schlauchs 220, einschließlich des Inneren des Abschnitts, auf dem der zweite Stent montiert ist, zu verlaufen. Der Führungsdraht 12 muss den Schlauch 220 zwischen der Öffnung 400 und dem proximalen Ende des Schlauchs 220 nicht wieder verlassen.

In a second multiple stent deployment procedure, two stents are deployed 52 , 54 using a single stent arrangement which additionally comprises a second stent 54. (The one related to 1 to 4D described stent 52 is the "first" stent according to this method and arrangement). As in the flowchart of 5 As can be seen, the second method of deploying multiple stents includes the following steps:

• Steps S01 and S02, as described above, in any order;
• Step S05 Passing the guide wire through the tube section on which the second stent is mounted or is to be mounted. The guide wire 12th preferably passes through the opening 400 inside the hose 220 on / on again, as in the 4A-4D ; and
• Step S06 Place the second stent 54 around a portion of the tube proximal to the first stent 52 to surround. In embodiments there is an intermediate gap between the first and second assembled stents, for example around the guidewire 12th to allow through the opening 400 inside the hose 220 including the interior of the portion on which the second stent is mounted. The guide wire 12th needs the hose 220 between the opening 400 and the proximal end of the tube 220 not leave again.

As in the flowchart of 5 As shown, steps S05 and S06 can be carried out in any order, ie first step S05 and then step S06 or first step S06 and then step S05.

After performing steps S01, S02, S05 and S06, it can be seen that the stent assembly 101 in a "double stent-stent advancement arrangement" in which the guidewire 12th first through the distal and proximal openings 320 , 262 extends around the guidewire holding portion 222 to go through inside. The first stent 52 is arranged to surround a stent delivery tube section proximal to the guidewire holding section 222 is offset. The guide wire 12th continues through the opening 400 between the two stents 52 . The second stent is arranged to surround a second stent delivery tube section proximal to the first stent 52 and from the opening 400 is offset. The dual stent-stent advancement assembly is for advancing the first and second stents 52 , 54 together with the stent delivery tube 220 along the guide wire 12th in a body lumen of a human person.

• Schritte S03 und S04, wie oben beschrieben;
• Schritt S07 Vorschieben des zweiten Stents entlang des Schlauchs und Vorschieben des Schlauchs entlang des Führungsdrahts zusammen mit dem zweiten Stent, um den zweiten Stent an den Zielort zu bringen; und
• Schritt S08 Zurückziehen des Schlauchs und des Führungsdrahts, um den Stent im Lumen zu entfalten.

The procedure also includes:

• Steps S03 and S04 as described above;
• Step S07 advancing the second stent along the tube and advancing the tube along the guide wire together with the second stent to deliver the second stent to the target location; and
• Step S08 Withdraw the tube and guidewire to deploy the stent in the lumen.

Steps of the immediate method for deploying multiple biliary stents in a lumen of a human body are related to the 6A-E explained in more detail.

6A shows the positions of the first and second stents 52 , 54 after step S04 and before step S07. The stent 52 is in the lumen 4th inserted, and the guide wire 12th is from the stent delivery tube 220 solved. In contrast to 4D which represents an embodiment in which the (first) stent 52 the only stent was the one with the Guide wire 12th is inserted is in 6A the second stent 54 can be seen as it rests on the tubing section proximal to the opening 400 is mounted. Optional hose 220 distally in the direction indicated by arrow A4.

With reference to FIG. 4A, it is additionally noted that, according to some embodiments, a fixed distance of at least 1 mm and / or not more than 80 mm between the first stent 52 and the second stent 54 (not shown in FIG 7B) due to the securing of the second stent 54 so that there is distal movement prior to deployment of the first stent 52 is prevented. An example of such a locking mechanism is described below with reference to FIG 8A-8D described. In some embodiments the fixed distance is at least 5 mm, and for some applications the fixed distance is no more than less than 25 mm.

With reference to 6B is shown how the second stent 54 (as indicated by arrow A5) over the stent delivery tube 220 and over the guide wire 12th is advanced while executing step S07. At this point, the distal end of the second stent 54 is distal from the opening 400 advanced what in 6B can no longer be seen. It is noted that during step S07, when the second stent 54 is deployed, the guide wire 12th within the lumen 4th and not proximal or distal in the lumen 4th , at least not for the purpose of carrying out the present proceedings.

In 6C shows the position of the second stent 54 at the end of step S07. The second stent was next to the first stent 52 in the lumen 4th advanced to the target site. In some embodiments, as in 6C shown, a trigger hose 60 can be used to facilitate the distal advancement of the second stent 54 along the stent delivery tube and / or to "push" the second stent 54 from the distal end of the tube 220 to facilitate when the hose 220 is withdrawn proximally in step S08.

The implementation of step S08 is in FIG 6D-6E shown. In 6D it can be seen that the stent delivery tube 220 was withdrawn from the second stent 54, which is now anchored in the lumen. After all, in 6E to see that the guidewire 12th has also been withdrawn.

From the foregoing discussions it will be apparent to those skilled in the art that various methods can be used to deploy three stents including, without limitation: Using the first method (steps S01 .. S04) to deploy a single stent three times (once for each stent) supported by the same guidewire each time, the guidewire remaining in place after at least the first and second stents have been deployed; and using the first method to deploy a single stent, with the guidewire in place thereafter, and then using the method to deploy two stents (steps S01 .. S08).

Discussion of the stent closure mechanisms

It is now on the 7A - 7B and 8A - 8D Reference, the schematic representations of occlusion mechanisms configured to constrain movement of the first stent 52 and optionally the second stent 54 with respect to the guide tube. The occlusion mechanisms are typically used to enable stents, along with the guiding tube, to be advanced in a controlled manner within the lumen of the person. As soon as the doctor has removed each locking mechanism, the respective stent can be deployed in the lumen at the distal end of the guide tube. The specific design example described below is intended to be illustrative and not restrictive. In addition, the description relates generally to embodiments in which two stents 52 , 54 can be used together for use in accordance with the method described above in relation to steps S01 .. S08, however, with the necessary modifications, can be applied equally to the individual stent arrangements and the method described above.

First, a first locking mechanism is used 600 Referred to proximal and distal movement of the first stent 52 in relation to the hose 220 to prevent as in the 7A , 7B , 8A and 8D is pictured. The first locking mechanism 600 is configured to allow proximal movement of the first stent 52 to prevent past a point that is at least 1 to 80 mm (e.g. 2 to 80 mm, e.g. 5 to 80 mm, e.g. 5 mm) distal to the distal end of the second stent 54, if any , is. Additionally is the first interlock 600 configured to allow distal movement of the stent 52 to prevent so the stent 52 not from the distal end of the stent delivery tube 220 slips off while in the lumen 4th the person is advanced until a desired implantation site is reached and the doctor uses the first locking mechanism 600 away.

Typically, the first includes a locking mechanism 600 a first locking wire 610 and a fastening loop 620 .

The closure loop 620 is typically on the hose 220 attached by the loop through two side holes 614 is looped in the in the 8A and 8D shown stent delivery tube 220 are provided.

The first locking wire 610 typically comprises a thin metal or polymer wire 0.1 to 0.35 mm in diameter, e.g. B. 0.2 mm. The first locking wire 610 typically runs from the proximal portion of the stent assembly 101 between the hose 220 and an interior surface of the first and second stents 52 and 54 and is through the closure loop 620 (typically accessible through the locking loop 620 through a hole in the wall of the first stent 52 ) guided.

The first locking wire 610 emerges from the first stent 52 through the distal end 55 of the stent 52 and is next to the side of the guide hose 220 distal to the distal end 55 arranged. For some applications, such as those in the 7A and 8A shown, the locking wire runs 610 through a side hole 612 in the side of the hose 220 , wanders over the hose 220 and leaves the hose 220 via an additional side hole 612 on the opposite side. The locking wire 610 then runs proximally along the inner surface of the first stent 52 outside the hose 220 . This secures the first stent 52 in place and prevents distal or proximal movement of the stent 52 . Additionally, in embodiments that include the slot 280 / Slit lips 282 - Use design when the first lock wire 610 through side holes 612 runs, the slit lips 282 brought into contact with each other to make the slot 280 keep in a closed state.

Alternatively, as in the 7B and 8D shown, the locking wire runs 610 after threading through the closure loop 620 still distal outside the tube 220 .

Once the stent 52 is at the desired location in the person's lumen, the doctor pulls the first locking wire 610 proximal, causing the closure of the first stent 52 by loosening the locking wire 610 from the closure loop 620 is resolved. This release allows proximal movement of the tube 220 , the first stent 52 distal from the delivery hose 220 , e.g. B. in step S04 of 3 or 5 is unfolded.

Reference will now be made to a second locking mechanism, which is a locking wire 640 comprises to move the second stent 54 distally with respect to the stent delivery tube 220 as in the 8B and 8C shown to prevent.

As in 8B As shown, the second stent 54 is shaped to have a hole 544 in a portion of the second stent 54 (e.g., in the anchor tab 540 ) Are defined. There is also a trigger hose 700 located proximal to the second stent 54 and configured to detach the second stent 54 from the guiding tube 220 push away, shaped so that there is a hole 706 in a section of the trigger tube (e.g. in a distal extension section 702 the trigger hose).

The second locking wire 640 runs through the hole 544 in the portion of the second stent 54 and through the hole 706 in the section 702 of the trigger hose 700 to prevent distal movement of the stent 54. After deploying the first stent 52 becomes the second locking wire 640 from the holes 544 and 706 removed, thereby releasing the obstruction of the second stent 54. The second stent 54 is then attached to the distal end of the guide tube 220 unfolds.

For some applications, such as those in 8B shown is the second lock wire 640 after passing the holes 544 and 706 in the direction of the trigger hose 700 looped back and then runs proximally along the inner surface of the trigger tube 700 outside of the guide hose 220 .

Alternatively, as in 8C shown the second locking wire 640 after passing the holes 544 and 706 further distally along the inner surface of the second stent 54 outside the tube 220 .

It should be noted that the first locking mechanism 600 not arranged so that a guidewire 12th used to provide distal or proximal movement of the first stent 52 to prevent. It should also be noted that the locking wire 640 not arranged so that a guidewire 12th is used to prevent distal movement of the second stent 54.

In some embodiments, the closure wires 610 and 640 in corresponding lumens in a wall of the trigger tube 700 be arranged.

The scope of the present invention includes the use of stents and stent assemblies in any suitable lumen to deploy multiple stents, tubes, or other devices in the lumen. For example, techniques described herein and Devices are used in a urethra and / or in a ureter and / or in a pancreatic duct and / or in an esophagus and / or in a trachea of the patient. Additionally or alternatively, the techniques and devices described herein can be used to deploy two or more prostate stents.

Additional discussion

1. a. einen Gallenstent; und
2. b. einen gestreckten Stentförderschlauch, umfassend einen Führungsdrahthalteabschnitt, der (i) jeweilige distale und proximale Öffnungen umfasst, die einen Führungsdrahtweg durch diese definieren, und (ii) einen längsgerichteten seitlich-passierbaren Teil, wobei:
   1. i. in einer Stentvorschiebe-Anordnung (A) der Führungsdraht durch die jeweiligen Öffnungen verläuft, um den Führungsdrahthalteabschnitt innen zu durchlaufen, und (B) der Stent so angeordnet ist, dass er einen Stentförderschlauchabschnitt umgibt, der proximal von dem Führungsdrahthalteabschnitt zum Vorschieben des Stents zusammen mit dem Stentförderschlauch entlang des Führungsdrahts in ein Körperlumen einer menschlichen Person versetzt ist, und
   2. ii. wenn der Stent in der Stentvorschiebe-Anordnung an einem Zieleinsatzort innerhalb des Lumens angeordnet ist, ein Zurückziehen des Stentförderschlauchs in proximaler Richtung bewirkt, dass der Führungsdraht den seitlich-passierbaren Teil des Führungsdrahthalteabschnitts, passiert, um den Führungsdraht vom Schlauch zu entkoppeln, ohne den Führungsdraht in Längsrichtung zu verschieben.

Inventive Concept 1. A device for use with a guide wire comprising:

1. a. a biliary stent; and
2. b. an elongated stent delivery tube comprising a guidewire retention portion including (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinally laterally passable portion, wherein:
   1. i. in a stent advancement arrangement (A) the guide wire extends through the respective openings to pass through the guide wire holding portion inside, and (B) the stent is arranged so that it surrounds a stent delivery tube portion which is proximal of the guidewire holding portion for advancing the stent together with the stent delivery tube is displaced along the guide wire into a body lumen of a human person, and
   2. ii. When the stent is arranged in the stent advancing arrangement at a target deployment site within the lumen, retraction of the stent delivery tube in the proximal direction causes the guide wire to pass the laterally passable part of the guide wire holding section in order to decouple the guide wire from the tube without the guide wire to move in the longitudinal direction.

Inventive Concept 2. The device of inventive concept 1, wherein in the stent advancement arrangement the stent is the only stent that is deployed with the guide wire.

Invention Concept 3. The device according to one of the inventive concepts 1-2, wherein the device comprises only a single stent, which is the biliary stent.

Invention Concept 4. The device according to one of the inventive concepts 1 to 3, which is provided as an assembled arrangement, so that (i) the individual biliary stent is attached to the stent delivery tube; and (ii) no other stent than the single biliary stent with the stent delivery tube is inserted.

Invention concept 5. The device of the invention concept 4, further comprising the guide wire which engages in the individual biliary stent and is in contact with it.

Invention concept 6. The device according to one of the inventive concepts 4 to 5, wherein both the individual biliary stent and the stent delivery tube mounted thereon are arranged in a common container, the container being closed.

Invention concept 7. The device of the invention concept 6, with no further stent than the biliary stent being present in the common container.

Invention Concept 8. The device of Invention Concept 3 is provided in a kit form so that the individual biliary stent is not mounted on the stent delivery tube, both the individual biliary stent and the stent delivery tube being arranged in a common and closed container and no further stent inside of the container is arranged.

Inventive Concept 9. The device according to any of inventive Concepts 6-8, wherein the common container is a bag.

Invention concept 10. The device according to one of the inventive concepts 6 to 9, an interior of the common container being sterile or pre-sterilized.

Invention Concept 11. The device according to any of the inventive concepts 6-10, wherein the common container is sealed.

Invention Concept 12. The device of Invention Concept 1 provided in a kit form so that the stent delivery tube is disposed in a closed container without a stent attached, an interior thereof being sterile or sterilized.

Invention Concept 13. The device of Invention Concept 3 is provided in a kit form so that the individual biliary stent is not mounted on the stent delivery tube, the biliary and stent delivery tube being arranged in corresponding closed containers that are mechanically engaged with each other, and none another stent is inserted mechanically with one of the containers.

Invention concept 14. The device according to one of the preceding inventive concepts, wherein (z. B. 2 B) several different slots in the longitudinal direction along the Guide wire holding portion are arranged, wherein the slots are spaced apart from one another in the longitudinal direction, so that the slots and non-slot portions of the guide wire holding portion alternate in the longitudinal direction.

Invention concept 15. The device according to one of the preceding inventive concepts, wherein (z. B. 2 B) a plurality of different pre-weakened sections are arranged in the longitudinal direction along the guide wire holding section, the pre-weakened sections being spaced apart from one another in the longitudinal direction, so that the pre-weakened sections and non-pre-weakened sections of the guide wire holding section alternate in the longitudinal direction.

Invention Concept 16. The device of a previous inventive concept in which a retraction of the stent delivery tube in the proximal direction is effective to cause the guide wire to pass the laterally passable part of the guide wire holding portion, which is achieved by applying a first proximal retraction force of at least 100 grams and not more than 20 kg or at least 500 grams and not more than 10 kg or at least 1 kg and not more than 5 kg or at least 1.5 kg and not more than 2.5 kg can be effected.

Invention concept 17. The device of the invention concept 16, wherein a retraction of the stent delivery tube in the proximal direction after the laterally passable part of the guide wire holding section through the guide wire is effected by a second proximal retraction force, the retraction force of which is less than the first proximal retraction force can be.

Inventive Concept 18. The device according to one of the preceding inventive concepts, wherein the retraction of the stent delivery tube in the proximal direction is effective in order to allow the stent to deploy in the lumen without manipulation of the guide wire.

Invention Concept 19. The device according to one of the preceding inventive concepts, wherein in the stent advancement arrangement the guide wire does not pass through the tube section surrounded by the stent on the inside.

Invention concept 20. The device according to one of the preceding inventive concepts, wherein the laterally passable part of the guide wire holding section comprises at least: (i) a slot with opposing slit lips and (b) a perforation or (iii) a thinned tube wall.

Invention Concept 21. The device of Invention Concept 1, wherein (i) the stent is a first stent and the device additionally comprises a second stent and (ii) in the stent advancement arrangement (A) the second stent is arranged such that it has a second Stent delivery tube section which is offset proximally from the first stent, in order to advance the second stent into the body lumen, and (B) the guidewire passes internally through the second stent delivery tube section.

1. a. Bereitstellen eines Führungsdrahts, eines Gallenstents und eines Stentförderschlauchs, wobei der Stentförderschlauch einen Führungsdrahthalteabschnitt und einen Stentförderschlauchabschnitt aufweist, der proximal davon versetzt ist;
2. b. Anordnen des Gallenstents, um den Stentförderschlauchabschnitt; und
3. c. Führen eines Endabschnitts eines Führungsdrahts durch jeweilige distale und proximale Öffnungen des Führungsdrahthalteabschnitts, um den Führungsdrahthalteabschnitt innen zu durchlaufen, wobei das Führungsdrahthalteabschnitt einen längsgerichteten seitlich-passierbaren Teil aufweist,

wobei
das Führen durch und Anordnen in Kombination wirksam ist, um einen zusammengebauten Zustand zu erreichen, in dem der Stentförderschlauch zusammen mit dem um ihn herum angeordneten Stent in Längsrichtung entlang des Führungsdrahtes vorschiebbar ist, wobei der Führungsdrahthalteabschnitt wirksam ist, um den Führungsdraht darin zu halten; und
die Stenteinsatzanordnung durch Verankern des Stents zerlegt werden kann, und wenn der Stent verankert ist, der Stentförderschlauch zumindest aus dem Inneren des Stents proximal herausgezogen wird, ohne den Führungsdraht zu manipulieren, wobei das proximale Zurückziehen des Schlauchs wirksam ist, den Führungsdraht dazu zu bringen, den seitlich-passierbaren Teil des Führungsdrahthalteabschnitts seitlich zu passieren und dadurch den Führungsdraht vom Schlauch zu entkoppeln.Inventive Concept 22. A method of assembly comprising:

1. a. Providing a guidewire, a biliary stent, and a stent delivery tube, the stent delivery tube having a guidewire holding portion and a stent delivery tube portion offset proximally therefrom;
2. b. Placing the biliary stent around the stent delivery tube section; and
3. c. Guiding an end portion of a guide wire through respective distal and proximal openings of the guide wire holding portion to traverse the guide wire holding portion internally, the guide wire holding portion having a longitudinally laterally passable portion,

in which
the routing and arranging in combination is effective to achieve an assembled state in which the stent delivery tube together with the stent disposed around it is longitudinally advanced along the guidewire, the guidewire holding portion being operative to hold the guidewire therein; and
the stent deployment assembly can be disassembled by anchoring the stent, and when the stent is anchored, the stent delivery tube is withdrawn from at least the interior of the stent proximally without manipulating the guidewire, the proximal withdrawal of the tube being effective to cause the guidewire to to pass the laterally passable part of the guide wire holding section and thereby decouple the guide wire from the tube.

Inventive Concept 23. The method of inventive concept 22, wherein in the stent deployment assembly, the stent is the only stent that is deployed with the guidewire.

Inventive Concept 24. The method according to one of the inventive concepts 22-23, wherein, after the method has been completed, only a single stent, which is the biliary stent, is attached to the stent delivery tube; and (ii) no other stent when the single biliary stent with the stent delivery tube is inserted.

Inventive Concept 25. The method according to one of the inventive concepts 22-25, wherein step (b) is carried out before step (c).

Inventive Concept 26. The method according to one of the inventive concepts 22-25, wherein step (c) is performed before step (b).

• das proximale Zurückziehen des Schlauchs das Aufbringen einer ersten proximalen Rückzugskraft umfasst, die wirksam ist, um zu bewirken, dass der Führungsdraht den seitlich-passierbaren Teil des Führungsdrahthalteabschnitts seitlich passiert, wobei die erste proximale Rückzugskraft mindestens 100 Gramm und nicht mehr als 10 kg oder mindestens 500 g und nicht mehr als 5 kg oder mindestens 1 kg und nicht mehr als 2,5 kg oder mindestens 1,5 kg und nicht mehr als 2 kg beträgt, und
• eine zweite proximale Rückzugskraft, die geringer ist als die erste proximale Rückzugskraft, wirksam ist, um den Stentförderschlauch nach dem seitlichen Passieren des seitlich-passierbaren Teils des Führungsdrahthalteabschnitts durch den Führungsdraht aus dem Stent herauszuziehen.

Inventive Concept 27. The method of any of inventive concepts 22-26, wherein:

• the proximal retraction of the tube comprises applying a first proximal retraction force effective to cause the guide wire to laterally pass the laterally passable portion of the guide wire holding portion, the first proximal retraction force being at least 100 grams and not more than 10 kg or at least 500 g and not more than 5 kg or at least 1 kg and not more than 2.5 kg or at least 1.5 kg and not more than 2 kg, and
• a second proximal retraction force, which is less than the first proximal retraction force, is effective in order to pull the stent delivery tube out of the stent after the guide wire has laterally passed the laterally passable part of the guide wire holding section.

Invention Concept 28. The method according to one of the inventive concepts 22-26, wherein in the stent advancement arrangement the guide wire does not pass through the tube section surrounded by the stent on the inside.

• anordnen eines zweiten Stents, um einen zweiten Stentförderschlauchabschnitt zu umgeben, der proximal vom ersten Stentförderschlauchabschnitt versetzt ist; und führen des proximalen Endabschnitts des Führungsdrahts durch eine Öffnung, die proximal vom ersten Stentförderschlauchabschnitt und distal vom zweiten Stentförderschlauchabschnitt angeordnet ist, so dass der Führungsdraht den zweiten Stentförderschlauchabschnitt innen durchläuft.

Invention concept 29. The method according to invention concept 22, wherein (i) the stent is a first stent and the stent delivery tube section is a first stent delivery tube section and (ii) the method additionally comprises:

• arranging a second stent to surround a second stent delivery tube section offset proximally from the first stent delivery tube section; and guiding the proximal end section of the guide wire through an opening which is arranged proximally from the first stent delivery tube section and distal from the second stent delivery tube section, so that the guide wire runs through the inside of the second stent delivery tube section.

Invention concept 30. The method according to one of the invention concepts 22-29, wherein (e.g. see 2 B) a plurality of different slots are arranged in the longitudinal direction along the guide wire holding section, the slots being spaced apart from one another in the longitudinal direction, so that the slots which are spaced apart in the longitudinal direction and non-slit sections of the guide wire holding section alternate in the longitudinal direction.

Invention concept 31. The method according to one of the inventive concepts 22 to 30, wherein (z. B. 2 B) a plurality of different pre-weakened sections are arranged in the longitudinal direction along the guide wire holding section, the pre-weakened sections being spaced apart from one another in the longitudinal direction, so that the pre-weakened sections and non-pre-weakened sections of the guide wire holding section alternate with one another in the longitudinal direction.

Inventive Concept 32. The device of inventive concept 5, wherein in the stent advancement arrangement the guide wire does not internally pass through the tube section surrounded by the stent.

Invention concept 33. The device according to one of the invention concepts 1-21 or invention concept 32, wherein (for example, see 2 B) a plurality of different thinned tube wall sections are arranged in the longitudinal direction along the guide wire holding section, the thinned tube wall sections being spaced apart from one another in the longitudinal direction, so that the thinned tube wall sections and sections in which the tube wall of the guide wire holding section is thicker alternate with one another in the longitudinal direction.

List of reference symbols

220

Stent delivery tube

12th

Guide wire

1001

arrow

222

first distal section

320

distal opening

262

proximal opening

278

Longitudinal, laterally passable part

232

section

101

Stent construction

52

Biliary stent

98

Detail box

280

slot

282

Slit lips

284

Weakened side wall part

522

Anchoring tabs

4th

Lumens

400

opening

1002

arrow

1005

arrow

60

Trigger hose

600

first locking mechanism

610

first locking wire

620

Closure loop

614

side holes

55

distal end

612

side hole

640

second blocking with locking wire

544

hole

540

Anchoring tab

700

Trigger hose

706

hole

702

distal extension part

Claims (14)

Apparatus for use with a guidewire (12) comprising: a. a biliary stent (52); and b. an elongated stent delivery tube (220) that includes a guidewire retention portion (232) that includes (i) respective distal and proximal openings defining a guidewire path therethrough, and that (ii) includes a longitudinal, laterally passable portion (278), wherein : i. in a stent delivery arrangement, (A) the guidewire (12) passes through the respective openings so that it passes internally through the guidewire holding portion (232), and (B) the stent is arranged to enclose a portion (232) of the stent delivery tube (220), the section (232) being offset proximally to the guide wire holding section (232) in order to push the stent together with the stent delivery tube (220) along the guide wire (12) forwards, and ii. When the stent is in the stent advancement arrangement, proximal retraction of the stent delivery tube (220) relative to the stent causes the guidewire (12) to pass the laterally passable portion of the guidewire holding portion (232) so that the guidewire (12) from the Hose is decoupled without the guide wire (12) being displaced lengthwise, the device only comprising a single stent, which is the biliary stent (52). The device according to Claim 1 , provided as an assembled assembly such that (i) the single biliary stent (52) is attached to the stent delivery tube (220); and (ii) none other than the single biliary stent (52) is inserted with the stent delivery tube (220), the device further comprising the guidewire (12) engaging and in contact with the single biliary stent (52). The device according to Claim 1 wherein both the single biliary stent (52) and the stent delivery tube (220) are arranged in a common container, the container being closed. The device according to Claim 1 wherein both the single biliary stent (52) and the stent delivery tube (220) attached thereto are arranged in a common container, the container being closed. The device according to Claim 1 wherein both the single biliary stent (52) and the stent delivery tube (220) to which the biliary stent (52) is attached are arranged in a common container, the container being closed. The device according to one of the Claims 3 to 5 wherein there is no other stent than the biliary stent (52) in the common container. A kit for use with a guidewire (12), the kit comprising: a. a biliary stent (52); and b. an elongated stent delivery tube (220) including a guidewire (12) retention portion (232), the (i) respective distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinal, laterally passable portion (278) wherein: A. the kit comprises only a single stent which is the biliary stent (52); B. the kit is provided so that the single biliary stent (52) is not attached to the stent delivery tube (220); C. Both the individual biliary stent (52) and the stent delivery tube (220) are arranged in a common and closed container and no further stent is arranged in the container; and D. when the kit is assembled: i. in a stent delivery arrangement, (A) the guidewire (12) passes through the respective openings so that it passes internally through the guidewire holding portion (232), and (B) the stent is arranged to enclose a portion (232) of the stent delivery tube (220), the portion (232) proximal to the Guidewire holding portion (232) is offset to advance the stent together with the stent delivery tube (220) along the guidewire (12), and ii. When the stent is in the stent advancement arrangement, proximal retraction of the stent delivery tube (220) relative to the stent causes the guidewire (12) to pass the laterally passable portion of the guidewire holding portion (232) so that the guidewire (12) from the The tube is decoupled without the guide wire (12) being displaced lengthways. A kit for use with a guidewire (12), the kit comprising: a. a biliary stent (52); and b. an elongated stent delivery tube (220) including a guidewire (12) retention portion (232), the (i) corresponding distal and proximal openings defining a guidewire path therethrough, and (ii) a longitudinal, laterally-passable portion ( 278) includes, in which: A. placing the stent delivery tube (220) in a closed container with no stent mounted thereon, an interior thereof being sterile or sterilized; and B. when the kit is assembled: i. in a stent delivery arrangement, (A) the guidewire (12) passes through the respective openings to pass inside the guidewire holding portion (232), and (B) the stent is arranged to enclose a portion (232) of the stent delivery tube ( 220), the section (232) being offset proximally to the guide wire holding section (232) in order to push the stent together with the stent delivery tube (220) along the guide wire (12) forwards, and ii. When the stent is in the stent advancement arrangement, proximal retraction of the stent delivery tube (220) relative to the stent causes the guidewire (12) to pass the laterally passable portion of the guidewire holding portion (232) so that the guidewire (12) from the The tube is decoupled without the guide wire (12) being displaced lengthways. The kit according to Claim 8 with only a single stent which is a biliary stent (52). A kit for use with a guidewire (12), the kit comprising: a. a biliary stent (52); and b. an elongated stent delivery tube (220) including a guidewire retention portion (232) which includes (i) respective distal and proximal openings defining a guidewire path therethrough, and which (ii) includes a longitudinal, laterally passable portion (278); in which: A. the kit includes only a single stent which is a biliary stent (52); B. the single biliary stent (52) is not attached to the stent delivery tube (220); C. the bile and the stent delivery tube (220) are each arranged in closed containers which are mechanically connected to one another and no further stent is mechanically inserted into one of the containers; D. when the kit is assembled: i. in a stent delivery arrangement, (A) the guidewire (12) passes through the respective openings to pass through the guidewire holding portion (232) internally, and (B) the stent is arranged to enclose a portion (232) of the stent delivery tube (220 ), which is offset proximally to the guide wire holding section (232), in order to push the stent together with the stent delivery tube (220) along the guide wire (12) forwards, and ii. When the stent is in the stent advancement arrangement, proximal retraction of the stent delivery tube (220) relative to the stent causes the guidewire (12) to pass the laterally passable portion of the guidewire holding portion (232) so that the guidewire (12) from the The tube is decoupled without the guide wire (12) being displaced lengthways. The kit or device according to one of the Claims 1 to 3 or 7th to 8th ,, wherein a retraction of the stent delivery tube (220) in the proximal direction so that the guide wire (12) passes the laterally passable part of the guide wire holding section (232) by applying a first proximal retraction force of at least 1 kg and not more than 5 kg, or at least 1.5 kg and not more than 2.5 kg can be effected. Apparatus for use with a guidewire (12) comprising: a. a biliary stent (52); and b. an elongated stent delivery tube (220) including a guidewire retention portion (232) having (i) respective distal and proximal openings defining a guidewire path therethrough and (ii) including a longitudinal, laterally passable portion (278), wherein: i. in a stent advancement arrangement (A) the guide wire (12) runs through the respective openings to pass through the guide wire holding section (232) inside, and (B) the stent is arranged so that it encompasses a section (232) of the stent delivery tube (220) , which is offset proximally to the guide wire holding portion (232), in order to push the stent together with the stent delivery tube (220) along the guide wire (12) forwards, and ii. When the stent is in the stent advancement arrangement, proximal retraction of the stent delivery tube (220) relative to the stent causes the guidewire (12) to pass the laterally passable portion of the guidewire holding portion (232) so that the guidewire (12) from the The tube is decoupled without the guide wire (12) being displaced lengthways. wherein a retraction of the stent delivery tube (220) in the proximal direction so that the guide wire (12) passes the laterally passable part of the guide wire holding section (232) by applying a first proximal retraction force of at least 1 kg and not more than 5 kg, or at least 1 .5 kg and not more than 2.5 kg can be effected. A method of assembly comprising: a. Providing a guide wire (12), a biliary stent (52) and a stent delivery tube (220), the stent delivery tube (220) having a guide wire holding portion (232) and a portion (232) of the stent delivery tube (220) offset proximally therefrom; b. Placing the biliary stent (52) around the portion (232) of the stent delivery tube (220); and c. Guiding an end section of the guide wire (12) through corresponding distal and proximal openings of the guide wire holding section (232) so that it passes through the guide wire holding section (232) inwardly, the guide wire holding section (232) having a longitudinally directed, laterally passable part (278), in which the guiding through and arranging in combination are effective to achieve an assembled state in which the stent delivery tube (220) together with the stent arranged around it can be advanced in the longitudinal direction along the guide wire (12), the guide wire holding section (232 ) causes the guidewire (12) to be retained therein; and the stent insert assembly can be disassembled by anchoring the stent and with the anchored stent the stent delivery tube (220) is withdrawn at least from the interior of the stent without manipulating the guide wire (12) proximally, the withdrawal of the tube causing the guide wire (12) the laterally passable part of the guide wire holding section (232) passes laterally and thereby decouples the guide wire (12) from the tube, wherein, upon completion of the method, only a single stent, which is the biliary stent (52), is attached to the stent delivery tube (220); and (ii) no other stent than the single biliary stent (52) with the stent delivery tube (220) is inserted. The procedure according to Claim 13 wherein the proximal retraction of the tube includes the application of a first proximal retraction force that causes the guide wire (12) to pass the laterally passable portion of the guide wire holding portion (232), the first proximal retraction force at least 1 kg and not more than 2, 5 kg, or at least 1.5 kg and no more than 2 kg, and wherein a second proximal retraction force less than the first proximal retraction force causes the stent delivery tube (220) to be withdrawn from the stent after the guidewire (12) the laterally passable part of the guide wire holding portion (232) has passed.

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