WO2007110224A1

WO2007110224A1 - Prosthesis delivery system

Info

Publication number: WO2007110224A1
Application number: PCT/EP2007/002685
Authority: WO
Inventors: Jürgen Dorn
Original assignee: Angiomed Gmbh & Co. Medizintechnik Kg
Priority date: 2006-03-27
Filing date: 2007-03-27
Publication date: 2007-10-04
Also published as: GB0606093D0

Abstract

The invention concerns a prosthesis delivery system (1) for releasing a prosthesis (20) inside a bodily lumen, the delivery system comprising: an outer sheath (10) that defines a lumen (14) for receiving the prosthesis to be delivered, the lumen having an open distal orifice (12) that defines the distal end of the lumen, the open distal orifice serving to release the prosthesis, a prosthesis pusher (30) arranged inside the lumen movable relative to the outer sheath, the prosthesis pusher having a push surface (32) to push the prosthesis, a post-dilator (40) for post-dilating the released prosthesis, the post-dilator being arranged inside the lumen of the outer sheath, proximal of the prosthesis pusher.

Description

Prosthesis Delivery System

Technical Field

This invention relates to a prosthesis delivery system for releasing a prosthesis, in particular a stent, inside a bodily lumen.

Background Art

A delivery system for a self-expanding stent which is delivered by proximal withdrawal of a sheath radially surrounding the stent, is described in WO 03/003944 A2 of the present Applicant. The delivery system described in this publication has a prosthesis pusher element which defines a lumen for a guide-wire and a pusher strand that extends to the proximal end of the delivery system and bears an endwise compressive stress during release of the stent. A transfer shaft links the distal end of the pusher strand to the pusher element and lies side-by-side with the guide-wire. A tubular sheath surrounds the pusher assembly and comprises a tapered tip at the distal most end.

In document WO 01/34061 Al of the present Applicant, an implant delivery device is disclosed for delivery of a self- expanding stent to stenting sites within the body. The device is achieved by providing a catheter which receives the stent at its proximal end and guides it to the stenting site. The catheter serves as a guide catheter and has a tapered distal tip from which the stent emerges at the site of stenting. This system has particular application to stenting the carotid artery.

Furthermore, in carotid stenting a post-ballooning of a self- expanded stent has become mandatory. Summary

It is an object of the present invention to provide a prosthesis delivery system for releasing a prosthesis, in particular a stent, inside a bodily lumen which offers the medical practitioner a simple to handle system for prosthesis placement .

According to one aspect, the prosthesis delivery system for releasing a prosthesis inside the bodily lumen comprises an outer sheath that defines a lumen for receiving the prosthesis to be delivered, the lumen having an open distal orifice that defines the distal end of the lumen, the open distal orifice serving to release the prosthesis, furthermore, a prosthesis pusher arranged inside the lumen movable relative to the outer sheath, the prosthesis pusher having a push surface for pushing the prosthesis, and a post dilator for post dilating the released prosthesis, the post dilator being arranged inside the lumen of the outer sheath, proximal of the prosthesis pusher.

The provision of an outer sheath with a lumen that receives the prosthesis along with a post dilator achieves a simple to handle system for prosthesis placement inside a bodily lumen.

The simple handling is due to the fact that the two steps of releasing the prosthesis inside the bodily lumen and post dilation can be carried out by the same prosthesis delivery system. Accordingly, the two steps of releasing the prosthesis and its post dilation can be carried out using the same instrument which saves time, reduces trauma for the patient and may even increase the precision of carrying out the post dilation step. In particular, the surgeon carrying out the procedure of delivering the prosthesis can carry out the release of the prosthesis inside the bodily lumen and the post dilation with the same instrument that remains at the delivery site since the prosthesis and the post dilator are released and/or operated from the same outer sheath. In other words, it is not necessary to withdraw the prosthesis delivery instrument from the body after the prosthesis has been placed in position and to consequently insert the post dilation instrument into the body, but both procedural steps can be carried out with the same instrument.

In this description the term "delivery site" is intended to mean the site inside the patient's body, in particular inside a bodily lumen of the patient, where the prosthesis is to be placed finally and where it is intended to remain after release .

In a preferred aspect, the post dilator is integrated with the prosthesis pusher. This can result in a very compact system design, in particular with regard to the longitudinal extension of the prosthesis delivery system.

In order to apply the conventional, and for some procedures mandatory, procedure of post dilating the prosthesis, the post dilator is preferably a post dilation balloon.

In a preferred embodiment, the system comprises a prosthesis arranged inside the lumen of the outer sheath and distally of the push surface of the prosthesis pusher. Preferably, the prosthesis is a stent and in particular a self-expanding stent. These preferred embodiments provide a ready-to-use system with a prosthesis already integrated in the lumen of the outer sheath. Accordingly, the prosthesis can be arranged by the manufacturer of the prosthesis in a predetermined manner inside the lumen such that the surgeon can readily and easily use the system without the need of any adjustments prior to use, in particular without the need to insert the prosthesis into the system prior to use. This arrangement assures that the prosthesis delivery system works reliably and operating errors or a mismatch between prosthesis and prosthesis delivery system can be avoided. In order to avoid trauma on the patient and to reduce the risk of removing plague or other debris from the vessel walls, the distal tip of the outer sheath can be tapered towards the open distal orifice.

Preferably, the wall over the length of said tapered tip is made distensible to allow the open distal orifice to expand. In a preferred embodiment, a distender is arranged in the lumen of the outer sheath, whereas the distender is arranged such that it can be urged distally along the lumen such that it presses radially outwardly the wall within the tapered tip. The use of a distensible tip allows a configuration of the prosthesis delivery system in which the tip can be made smoothly tapered and almost closed during the insertion of the delivery system into the bodily lumen through the vessels of the patient's body such that trauma and detachment of bodily tissue, debris or plaque can be reduced or avoided. At the same time, the orifice of the outer sheath can be expanded at the delivery site in order to release the prosthesis and/or the post dilator and/or, as will be described below, to retrieve a distal protection device.

In order to simplify the prosthesis delivery system and to achieve compact dimensions, in particular in the longitudinal extension of the prosthesis delivery system, the distender may be integrated with the prosthesis pusher.

In a different aspect, the system serves further to retrieve from the bodily lumen a device attached to the distal end of a pull line. In particular, with the pull line extending from the device to be retrieved through a lumen of the distender, the device can be pulled proximately by the pull line relative to the outer sheath at least partially inside the lumen of the distender and/or inside the lumen of the outer sheath, in particular inside the former prosthesis lumen. The device attached to the distal end of the pull line can be a distal protection device for filtering a bodily fluid within the bodily lumen or for occluding the bodily lumen downstream of the delivery site. In this configuration of the system it is not only possible to release a prosthesis and post dilate the prosthesis, but also to retrieve a distal protecting device from the bodily lumen. Such a distal protecting device can be an embolic filter which, in some respects, resembles an umbrella with ribs extending radially outwardly from a hub and a mesh which extends between the ribs. The distal protection device could also be an occlusion balloon. These distal protection devices are inserted into the bodily lumen downstream of the surgical site in order to catch all material that is detached from the vessel wall during the insertion of the prosthesis delivery system, the procedure of releasing the prosthesis and the post dilation procedure. In particular, an embolic filter catches all plaque, debris or tissue parts that are separated from the vessel walls when the stenosis is pre-dilated, when the prosthesis delivery system is put through the pre-dilated stenosis, when the prosthesis is released at the delivery site and is being expanded or self-expanded and when the post dilation step of the readily expanded prosthesis takes place.

All these procedural steps carry the risk that plaque or other debris swims through the carotid aorta in the direction of the brain and causes adverse consequences. Therefore, a distal protection device in the form of an embolic filter or an occlusion balloon can be placed downstream of the delivery site. After the procedure of releasing the prosthesis and the post dilation procedure, the distal protection device can be retrieved, as has been described above, by the prosthesis delivery system as described herein.

In a further preferred embodiment, the prosthesis pusher comprises radiopaque material and/or the outer sheath comprises radiopaque markers and/or the prosthesis comprises radiopaque markers. This enables the surgeon to determine the exact position of the prosthesis pusher relative to the outer sheath when operating the prosthesis delivery system. In particular, by the relative positions of the radiopaque markers of the outer sheath and the prosthesis pusher and, optionally, the prosthesis, the surgeon can determine the status of the prosthesis delivery process. Furthermore, when the prosthesis pusher itself comprises radiopaque material and is integrated with the post dilator, also the position of the post dilator can be determined when it is inserted into the readily expanded prosthesis after the prosthesis is released inside the bodily lumen. Accordingly, the surgeon can see on an x-ray screen or other imaging device whether or not the post dilator is in the right position to post dilate the readily self-expanded prosthesis.

In order to use the prosthesis delivery system with conventional catheter systems, the prosthesis delivery system as described herein, preferably has a lumen for receiving a guide-wire, said lumen being provided in the prosthesis pusher and the post dilator such that a guide-wire can be pushed at least through the lumen of the outer sheath, the prosthesis pusher and the post dilator. In this regard, the prosthesis delivery system is preferably designed as an rapid exchange catheter or an over-the-wire catheter. Accordingly, the prosthesis delivery system can be guided by the guide- wire through the bodily lumen to the final delivery site. This enables the surgeon to use the prosthesis delivery system as described herein with the conventional surgical procedure that he is used to. In doing so in combination with the fewer steps that have to be carried out, this gives the surgeon extra benefit from the prosthesis delivery system as described herein since only one instrument has to be inserted over the wire for prosthesis delivery, post dilation and retrieval of a distal protection device. In a preferred embodiment, a pusher strand is connected to the prosthesis pusher to urge the prosthesis pusher distally against the prosthesis. Preferably, the pusher strand is integrated with the post dilator such that the pusher strand is a part of the post dilator. This connection of the pusher strand to the prosthesis pusher makes operation of the delivery system easy since the prosthesis pusher can be operated from a remote position, in particular from the proximal end of the catheter.

In another preferred embodiment, a pipe is connected to the outer sheath to proximally withdraw the outer sheath relative to the prosthesis pusher. Preferably, the pusher strand is arranged inside a lumen of the pipe. Preferably, the lumen of the pipe is in fluid communication with the post dilator to provide an actuating fluid to the post dilator. The provision of the pipe enables the surgeon to operate the prosthesis delivery system from a remote position, in particular from a proximal end of the catheter and allows, on the other hand, the supply of an actuating fluid to the post dilator in order to expand the post dilator to carry out the post dilation of the released prosthesis. The coaxial arrangement of the pusher strand and the pipe enables a thin diameter of the catheter assembly from the outer sheath to the proximal end of the catheter.

In order to allow for a relative movement between the pipe and the post dilator, the pipe can be connected with the post dilator via a connecting tube such that the connection is fluid tight and the connecting tube is slidable with regard to the pipe. In a preferred embodiment, the connection tube and the pipe are in an telescopic arrangement. In a further embodiment, between the pipe and the post dilator a stowable tube element or bellows can be situated.

The provision of the lumen of the pipe being in fluid communication with the post dilator also enables the surgeon to provide an expanding fluid to the post dilator from a remote position.

In a further aspect, the present disclosure relates to a method of delivering a prosthesis inside a bodily lumen, the method comprising the steps retaining the prosthesis in a lumen within an outer sheath, advancing the outer sheath to the delivery site inside the bodily lumen, releasing from the lumen within the outer sheath the prosthesis into the bodily lumen by movement of the outer sheath relative to the prosthesis, advancing from the lumen of the outer sheath a post dilator into the released prosthesis, post dilating the prosthesis by expanding the post dilator, and retracting the post dilator inside the lumen of the outer sheath.

The method preferably further comprises the step of retrieving a distal protection device attached to the pull line by pulling the distal protection device proximally relative to the outer sheath, at least partially inside the lumen of the outer sheath, in particular inside the former prosthesis lumen.

Brief Description of the Drawing

For a better understanding of the present invention, and to show more clearly how the same may be carried into effect, reference will now be made, by an example, to the accompanying drawing in which

Figure 1 is a lengthwise diametrical section of the distal end of a prosthesis delivery system in accordance with the present disclosure.

Detailed Description of the Preferred Embodiment

Referring to Figure 1, a prosthesis delivery system 1, in particular a percutaneous transluminal catheter system, for releasing a prosthesis inside a bodily lumen is shown in a schematic cross section. The prosthesis delivery system 1 has a distal end 2 and a proximal end 4.

In the following description of a preferred embodiment, the prosthesis that is to be delivered inside a bodily lumen is a stent 20.

In the drawing and in the description, the term "proximal" as is traditional, will refer to the end of the prosthesis delivery system 1 which is closer to the user, in this case to the surgeon, while the term "distal" will refer to the end which is further away from the surgeon. In other words, the distal end 2 of the prosthesis delivery system 1 is the end that is introduced first into the bodily lumen and that is inserted furthest .

The prosthesis delivery system 1 as shown in Figure 1 comprises an outer sheath 10 that defines a lumen 14 within. In the shown embodiment, the outer sheath 10 is shaped in an elongated, tubular form, but can have any form suitable for a particular purpose. The lumen 14 has an open distal orifice 12 that defines the distal end of the lumen 14, the open distal orifice 12 serves, inter alia, to release the stent 20.

Inside the lumen 14 of the outer sheath 10, a prosthesis pusher 30 is arranged that is movable relative to the outer sheath 10, whereas the prosthesis pusher 30 has a distal end face 32 and a proximal end face 34. In the shown embodiment, the distal end face is designed to be a push surface 32 that is in an end-to-end abutment relationship with the proximal end face 24 of the stent 20 such that it can push the stent. The stent 20 is compressed to be received inside the lumen 14 of the outer sheath 10. The stent has a distal end face 22 and a proximal end face 24. The proximal end face 24 of the stent 20 is in an end-to-end abutment relationship with the push surface 32 of the prosthesis pusher 30.

The stent 20 that is compressed or narrowed down in the lumen 14 of the outer sheath 10, is a self-expanding stent that will expand, once released, to a previously determined shape. In particular, the stent 20 can be made of a shape memory alloy such as Nitinol and expand to a desired shape when it is released from the lumen 14 of the outer sheath 10.

The prosthesis pusher 30 serves to keep the stent 20 in position relative to a bodily lumen (not shown) when the outer sheath 10 is retracted relative to the prosthesis pusher 30 and relative to the stent 20. This relative movement can also be described by a pushing movement of the prosthesis pusher 30 that pushes the stent 20 through the orifice 12 of the outer sheath 10 relative to the outer sheath 10. However, in order to assure a proper alignment and positioning of the stent 20 at the stenting site (or, delivery site) in the bodily lumen, it is preferred that the prosthesis pusher 30 keeps the stent 20 in a fixed position relative to the bodily lumen as soon as the prosthesis delivery system 1 has been placed in the proper position for releasing the stent. Then, the outer sheath 10 is retracted such that the orifice 12 is drawn over the stent 20 in order to release the stent 20 from the prosthesis delivery system 1.

The prosthesis delivery system 1, furthermore, comprises a post dilator 40 for post dilating the released stent 20. The post dilator is arranged inside the lumen 14 of the outer sheath 10 and is arranged proximal of the prosthesis pusher 30 and also proximal of the stent 20, in its not released state as well as generally in its released state. In other words, the prosthesis pusher 30 is situated between the stent 20 and the post dilator 40. In particular, as can be seen in Figure 1, the prosthesis pusher 30 is situated spaced apart from the post dilator 40. In other words, the post dilator 40 and the prosthesis pusher 30 are two distinct elements.

The post dilator 40 is also movable within the lumen 14 of the outer sheath 10 relative to the outer sheath 10. When the stent 20 is released from the prosthesis delivery system 1 and is readily self-expanded at its final stenting site, the post dilator 40 can be advanced through the lumen 14 of the outer sheath 10 and through the distal orifice 12 in order to be threaded or inserted inside the expanded stent 20. Since the stent 20 is, even in its expanded state, in a position in the bodily lumen relative to the prosthesis pusher 30 that is still in an generally end-to-end relationship between the proximal end face 24 of the stent 20 and the push surface 32 of the prosthesis pusher 30, the post dilator 40 only needs to be advanced through the stent 20 a length that corresponds to the length of the combined post dilator 40 and prosthesis pusher 30 assembly. As soon as the post dilator 40 is inserted into the released and expanded stent 20, the post dilator 40 can be expanded for post dilation.

The prosthesis pusher 30 is connected to a pusher strand 72 such that a movement of the pusher strand 72 also moves the prosthesis pusher 30. Furthermore, the prosthesis pusher 30 is connected to the post dilator 40 such that the pusher strand also moves the post dilator 40 when it moves the prosthesis pusher 30. In particular, the pusher strand is integrated with the post dilator 40 such that the pusher strand 72 is part of the post dilator 40.

At the proximal end 4 of the prosthesis delivery system 1, not only the pusher strand 72 is fed into the outer sheath 10 in the distal direction, but also a pipe 74 enters the outer sheath 10. The pipe 74 is fixedly connected to the outer sheath 10 and serves to move the outer sheath 10 relative to the prosthesis pusher 30 in order to retract the outer sheath 10 relative to the stent 20 for releasing the stent 20. In the embodiment shown in Figure 1, the pipe 74 is connected to the outer sheath 10 via a guide element 80. The guide element 80 is formed to have two lumens 82 and 84 and is fixedly attached to the outer sheath 10. The pipe 74 is mounted to the lower lumen 84 of the guide element 80, as shown in Figure 1. The connection between the pipe and the guide element 80 can be effected by usual means such as using an adhesive, by welding, by soldering, by crimping or any other suitable means and/or method.

The pipe 74 has a lumen 740 which is in fluid communication with the post dilator 40 in order to supply an actuating fluid to the post dilator 40. The post dilator preferably is a post dilating balloon 40.

The lumen 740 of the pipe 74 and the lumen of the post dilator 40 are connected via a connecting tube 78 that is fixedly attached to the post dilator 40. In order to enable a relative movement of the post dilator 40 relative to the outer sheath 10 in combination with a relative movement of the pusher strand 72 and the pipe 74, a sliding section 76 is provided that connects the pipe 74 with the connecting tube 78. In the sliding section 76, the inner diameter of the pipe 74 and the outer diameter of the connecting tube 78 are arranged such that the two tubular elements 74, 78 can slide with regard to one another in a telescope- like manner. In particular, the connecting tube 78 has an outer diameter that snugly fits into the inner diameter of the pipe 74. Preferably, this sliding connection 76 is fluid tight such that an actuating fluid can be supplied through the pipe 74 and the sliding section 76 to the post dilator 40.

Instead of the connecting tube 78 it is contemplated to use bellows or a stowable tube element, in particular made of PET, that is fixedly attached to both, the pipe 74 and the post dilator 40. In this arrangement, a relative movement between the pipe 74 and the pusher strand 72, as well as between the outer sheath 10 and the post dilator 40 can be achieved by bulging the bellows or stowable tube element.

The outer sheath 10 has at its distal end a tapered tip 16. The tapered tip serves to ease the insertion of the outer sheath 10 into a bodily lumen without removing plaque, debris or other contamination from the vessel walls. The distal tip 16 of the outer sheath 10 is tapered towards the open distal orifice 12.

The wall over the length of the tapered tip 16 is made distensible to allow the open distal orifice 12 to expand. In order to expand the distal tip 16, a distender 50 is provided inside the lumen 14 of the sheath 10 which can be urged distally along the lumen such that it presses radially outwardly the wall within the tapered tip 16. In the embodiment shown in Figure 1, the distender 50 is integrated with the prosthesis pusher 30.

The distender 50 can also serve to keep the distal orifice 12 of the outer sheath 10 open when the prosthesis delivery system 1 is further used to retrieve from the bodily lumen a device attached to the distal end of a pull line (not shown) , in particular a distal protection device (DPD) . In this case, the pull line extending from the device to be retrieved runs through a lumen 52 of the distender 50 whereas the device can be pulled proximately by the pull line relative to the outer sheath and to the distender 50 inside the lumen 52 of the distender 50 and/or inside the lumen 14 of the outer sheath 10, particular inside the former stent lumen.

The term "former stent lumen" is understood to mean the part of the lumen 14 within the outer sheath 10 in which the stent 20 has been carried to the stenting site. A guide-wire 60 can be pushed through the prosthesis delivery- system 1 in order to guide the prosthesis delivery system 1 to the stenting site. Accordingly, it is provided that a lumen 93 is present in the prosthesis pusher 30, a lumen 94 in the post dilator 40, as well as the lumen 14 in the sheath 10, whereas the different lumens 14, 93 and 94 are continuous with one another such that the guide-wire 60 can be pushed through at least parts of the distal end 2 of the prosthesis delivery system 1. Furthermore, the guide-wire 60 extends through the upper lumen 82 of the guiding element 80, as shown in Figure 1. In the rapid exchange system as shown in Figure 1, the guide-wire 60 enters into the sheath 10 of the prosthesis delivery system 1 via the distal guide-wire entrance 62, which is in the shown embodiment identical with the distal orifice 12, and exits the sheath 10 via a proximal guide-wire exit 64. Accordingly, at least the distal end 2 of the prosthesis delivery system 1 is guided by the guide- wire 60 in the manner as it is known from conventional rapid exchange catheters .

Preferably, the distal orifice 12 of the tapered tip 16 of the outer sheath 10, which is identical with the distal guide-wire entrance 62, has an open diameter that basically corresponds to the outer diameter of the guide-wire 60. In this manner, it can be assured that the insertion of the prosthesis delivery system 1 into the body of a patient can be carried out as gentle as possible since no leading sharp edges are present .

The prosthesis pusher 30 comprises radiopaque material. The radiopaque material serves the purpose that the surgeon can identify on an x-ray screen or other imaging device the exact position of the prosthesis pusher 30. Preferably, the stent 20 also comprises radiopaque markers (not shown) . Furthermore, the outer sheath 10 has radiopaque markers 18 that indicate the position of the outer sheath 10 inside the bodily lumen. By comparison of the relation of the images of the radiopaque material of the prosthesis pusher 30, of the radiopaque marker of the stent 20 and the radiopaque markers 18 of the outer sheath 10, the surgeon can analyze the actual position and process status of the different parts of the prosthesis delivery system 1.

Skilled readers will appreciate that the embodiment shown in the drawing is only an individual point within the scope of the inventive concept for which protection is sought in the present application. They will appreciate that percutaneous transluminal catheter systems, for various applications, have been proposed for many years and in a great variety of designs, giving an enormous range of design possibilities in the state of the art, and very great depth of design competence for those experienced in this field. For this class of readership, it should not be necessary to explain in detail how to select catheter materials and dimensions, for such design decisions are within the common general knowledge of this class of reader. It is intended that those designing, building and using catheter delivery systems the subject of this patent application will build upon the expertise that already exists in the state of the art at the priority date of this patent application.

Claims

1. Prosthesis delivery system (1) for releasing a prosthesis, in particular a stent (20), inside a bodily- lumen, the delivery system comprising:

an outer sheath (10) that defines a lumen (14) for receiving the prosthesis to be delivered, the lumen having an open distal orifice (12) that defines the distal end of the lumen, the open distal orifice serving to release the prosthesis there through,

a prosthesis pusher (30) arranged inside the lumen movable relative to the outer sheath, the prosthesis pusher having a push surface (32) for pushing the prosthesis ,

a post-dilator (40) for post-dilating the released prosthesis, the post-dilator being arranged inside the lumen of the outer sheath, proximal of the prosthesis pusher .

2. System according to claim 1, wherein the post-dilator is integrated with the prosthesis pusher.

3. System according to claim 1 or 2 , wherein the post- dilator is a post-dilation balloon.

4. System according to any one of the preceding claims, wherein the system comprises a prosthesis arranged inside the lumen of the outer sheath and distally of the distal end face of the prosthesis pusher.

5. System according to any one of the preceding claims, wherein the prosthesis is a stent, in particular a self- expanding stent, particularly made from a shape memory- material .

6. System according to any one of the preceding claims, wherein a distal tip (16) of the outer sheath is tapered towards the open distal orifice.

7. System according to claim 6, wherein the wall over the length of said tapered tip is made distensible to allow the open distal orifice to expand.

8. System according to claim 5 or 6 , wherein a distender (50) is arranged in the lumen of the outer sheath, the distender being arranged such that it can be urged distally along the lumen such that it presses radially outwardly the wall within the tapered tip.

9. System according to claim 8, wherein the distender is integrated with the prosthesis pusher.

10. System according to any of claims 6 to 9, wherein the system further serves to retrieve from the bodily lumen a device attached to the distal end of a pull line.

11. System according to claim 10, wherein, with the pull line extending from the device to be retrieved through a lumen (52) of the distender, the device can be pulled proximally by the pull line relative to the outer sheath at least partially inside the lumen of the distender and/or inside the lumen of the outer sheath, in particular inside the former prosthesis lumen.

12. System according to claim 10 or 11, wherein the device attached to the distal end of the pull line is a distal protection device for filtering a bodily fluid within the bodily lumen or occluding the bodily lumen.

13. System according to any one of the preceding claims, wherein the prosthesis pusher comprises radiopaque material .

14. System according to any one of the preceding claims, wherein the outer sheath comprises radiopaque markers

(18) .

15. System according to any one of the preceding claims, wherein a lumen (93, 94) for receiving a guide-wire (60) is provided in the prosthesis pusher and in the post- dilator such that a guide-wire can be pushed at least through the lumen of the outer sheath, the prosthesis pusher and the post -dilator .

16. System according to any one of the preceding claims, wherein the system is a rapid exchange catheter or an over-the-wire catheter.

17. System according to any one of the preceding claims, wherein a pusher strand (72) is connected to the prosthesis pusher to urge the prosthesis pusher distally against the prosthesis.

18. System according to claim 17, wherein the pusher strand is integrated with the post-dilator such that the pusher strand is part of the post-dilator.

19. System according to any one of the preceding claims, wherein a pipe (74) having a lumen (740) is connected to the outer sheath to proximally withdraw the outer sheath relative to the prosthesis pusher.

20. System according to claims 17 or 18 and 19, wherein the pusher strand is arranged inside the lumen of the pipe.

21. System according to claim 19 or 20, wherein the lumen of the pipe is in fluid communication with the lumen of the post-dilator to provide an actuating fluid to the post- dilator .

22. System according to claim 21, wherein the pipe is connected to the post dilator via a connecting tube (78) , whereas the connection is basically fluid tight and the connecting tube is slidable with regard to the pipe in order to allow for a relative movement between the pipe and the post dilator.

23. System according to claim 21 or 22, wherein the connection tube and the pipe are in a telescopic arrangement in order to allow for a relative movement between the pipe and the post dilator.

24. System according to claim 21, wherein between the pipe and the post dilator a stowable tube element or bellows are situated in order to allow for a relative movement between the pipe and the post dilator.

25. System according to one of the preceding claims, wherein the post dilator and the prosthesis pusher are situated spaced apart from one another.

26. System according to one of the preceding claims, wherein the post dilator and the prosthesis pusher are two distinct elements.

27. Method of delivering a prosthesis (20) inside a bodily lumen, the method comprising the following steps:

retaining the prosthesis in a lumen (14) within an outer sheath (10) ; advancing the outer sheath (10) to the delivery site inside the bodily lumen;

releasing from the lumen (14) within the outer sheath (10) the prosthesis into the bodily lumen by movement of the outer sheath relative to the prosthesis;

advancing from the lumen of the outer sheath a post- dilator (40) into the released prosthesis;

post-dilating the prosthesis by expanding the post- dilator; and

retracting the post -dilator inside the lumen of the outer sheath.

28. Method according to claim 27, further comprising the step of retrieving a distal protection device attached to a pull line by pulling the distal protection device proximally relative to the outer sheath, at least partially inside the lumen of the outer sheath, in particular inside the former prosthesis lumen.