SELF-EXPANDABLE STENT AND SET OF STENTS

Abstract

A self-expandable stent has a dry valve made of bovine pericardium arranged at a proximal end thereof, a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester. The dry valve is configured to be rehydrated when placed in contact with a solution, and the stent includes eyelets arranged at the proximal end of the stent for fixing the stent at a point of interest, with the point of interest being one of the vena cava superior and the vena cava inferior.

Claims

1. A self-expandable stent comprising: a dry valve made of bovine pericardium arranged at a proximal end of the stent; a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester, the dry valve configured to be rehydrated when placed in contact with a solution, and the stent comprising eyelets arranged at the proximal end of the stent to fix the stent at a point of interest, with the point of interest comprising one of a vena cava superior and a vena cava inferior.

2. The self-expandable stent according to claim 1, further comprising a distal end and a middle part arranged between the proximal end and the distal end, and the middle part spaced approximately 20 to 40% from the distal end and approximately 20 to 40% from the proximal end.

3. The self-expandable stent according to claim 1, further comprising a frame including a plurality of arms forming three interconnected parts.

4. The self-expandable stent according to claim 3, wherein, in an expanded state, the plurality of arms is outwardly directed in a distal end of the frame.

5. The self-expandable stent according to claim 3, wherein the frame is composed of Nitinol.

6. The self-expandable stent according to claim 1, further comprising a device configured to attach the proximal end of the stent at the vena cava or at a transition between the vena cava and a right atrium of a heart.

7. The self-expandable stent according to claim 1, wherein the dry bovine pericardium has a maximum tensile stress selected in the range of 15 to 25 MPa, or the rehydrated bovine pericardium has a tensile stress selected in the range of 15 to 20 MPa.

8. The self-expandable stent according to claim 1, wherein the dry bovine pericardium has a calcium content selected in the range of 0.01 to 0.1 g/Kg.

9. The self-expandable stent according to claim 1, wherein the dry valve comprises between two and six leaflets.

10. The self-expandable stent according to claim 1, wherein the dry bovine pericardium is formed by using a method comprising: soaking of the bovine pericardium treated with a crosslinking agent with a saline solution; contacting the soaked bovine pericardium with an aqueous solution comprising Hydrogen Peroxide; contacting the bovine pericardium with an aqueous solution comprising PBS and EDTA; contacting the bovine pericardium with a solution comprising glycerol, ethanol and EDTA; and contacting the bovine pericardium with a glycerol solution.

11. The self-expandable stent according to claim 1, wherein the stent is configured to be placed in the vena cava superior.

12. The self-expandable stent according to claim 11, further comprising a distal end and a middle part arranged between the proximal end and the distal end, and in an expanded state, a maximum outer diameter of the middle part is larger than a maximum outer diameter of the proximal end.

13. The self-expandable stent according to claim 12, wherein a transition between the middle part and the distal end has an outer diameter that is less than the maximum outer diameter of the middle part and less than an outer diameter of the distal end in the expanded state.

14. The self-expandable stent according to claim 11, further comprising a distal end and a middle part arranged between the proximal end and the distal end, and the skirt surrounds at least the proximal end and parts of the middle part of the stent.

15. The self-expandable stent according to claim 11, further comprising a distal end and a middle part arranged between the proximal end and the distal end, and in an expanded state, the maximum outer diameter of the distal end and a maximum outer diameter of the proximal end are generally the same.

16. The self-expandable stent according to claim 11, further comprising a frame including a plurality of arms forming three interconnected parts, and a distal end, and the ends of the arms at the distal end lie in a common plane and comprise eyelets.

17. The self-expandable stent according to claim 1, wherein the stent is configured to be placed in the vena cava inferior.

18. The self-expandable stent according to claim 17, further comprising a distal end and a middle part arranged between the proximal end and the distal end, and in an expanded state, a maximum outer diameter of the stent generally increases from the proximal end to the distal end.

19. The self-expandable stent according to claim 17, wherein the skirt surrounds at least the proximal end of the stent.

20. The self-expandable stent according to claim 17, further comprising a frame including a plurality of arms forming three interconnected parts, and a distal end, and the ends of the arms at the distal end lie in a common plane and comprise eyelets.

21. A set of stents comprising: two self-expendable stents, each of the two self-expendable stents having a dry valve made of bovine pericardium arranged at a proximal end of the stent, a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester, the dry valve configured to be rehydrated when placed in contact with a solution, and eyelets arranged at the proximal end of the stent to fix the stent at a point of interest such as a vena cava superior or inferior, a first stent of the two self-expendable stents configured to be placed in the vena cava superior, and a second stent of the two self-expendable stents configured to be placed in the vena cava inferior.

22. A device for delivering a self-expandable stent, the self-expandable stent having a dry valve made of bovine pericardium arranged at a proximal end thereof, a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester, the dry valve is configured to be rehydrated when placed in contact with a solution, and the stent comprising eyelets arranged at the proximal end of the stent to fix the stent at a point of interest, with the point of interest comprising one of a vena cava superior and a vena cava inferior, the self-expandable stent having a dry valve made of bovine pericardium arranged at a proximal end of the stent, a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester, the dry valve configured to be rehydrated when placed in contact with a solution, and the stent comprising eyelets arranged at the proximal end of the stent to fix the stent at a point of interest, with the point of interest comprising one of a vena cava superior and a vena cava inferior, the delivery device comprising: a flush port; a main body part configured to hold, inflate or release the stent; and an actuation mechanism to move the stent to a delivery site.

23. The device according to claim 22, wherein the actuation mechanism has a torque control and is capable of rotating the stent about an axis of the main body.

24. The device according to claim 22, further comprising a knob or the like at the actuation mechanism, with the knob being able to be rotated about an axis of rotation of the actuation mechanism.

25. Method of deploying a self-expandable stent, the self-expandable stent having a dry valve made of bovine pericardium arranged at a proximal end of the stent, a skirt surrounding the dry valve at the proximal end of the stent and made of one of bovine pericardium and polyester, the dry valve configured to be rehydrated when placed in contact with a solution, and the stent comprising eyelets arranged at the proximal end of the stent to fix the stent at a point of interest, with the point of interest comprising one of a vena cava superior and a vena cava inferior, comprising: delivering the stent with the device for delivering according to claim 22 for orthotopic or heterotopic applications at locations in the proximity of a tricuspid valve.

26. The method according to one of claim 25 comprising providing the self-expandable stent; inserting the self-expandable stent into a vein of a human or animal body using the delivery device; moving the stent to an application site with the delivery device; and deploying the stent at the application site.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The invention will be explained in more detail hereinafter with reference to the drawings.

[0078] FIG. 1A and FIG. 1B are examples of stents according to the invention in different sizes;

[0079] FIG. 2 is a photograph of a set of stents according to the invention; and

[0080] FIG. 3 is a device for delivering a self-expandable stent.

[0081] FIG. 1A and FIG. 1B both show self-expandable stents 10 in different sizes. The stents 10a of FIG. 1A relate to stents, which are configured to be placed in the SVC whereas the stents 10b of FIG. 1B relate to stents configured to be placed in the IVC.

DETAILED DESCRIPTION

[0082] All embodiments of the stents according to the invention comprise a frame 12 made out of a plurality of arms 14 which are fabricated of Nitinol. Nitinol is a flexible metal, which comprises the characteristic of being self-expendable. Hence, the stents 10 can be delivered in a compressed state to a point of interest such as the SVC or the IVC of a human since they can self-expand once they are deployed.

[0083] The frames 12 further comprise three parts, i.e. a proximal end PE, a distal end DE and a middle part MP, which are interconnected by the arms 14. The proximal end PE is characterized by being the end of the stent 10 which further includes a valve 16 made out of dry bovine pericardium as well as a skirt 18 made out of dry bovine pericardium and polyester. FIG. 1B also shows the leaflets 20 of the valve 16. The valve 16 can comprise between 2 and 6, preferably 4, leaflets.

[0084] In order to be able to attach the stents 10 at their respective points of interests, they comprise eyelets 22 at least at their respective proximal end PE, preferably at both ends PE and DE (see e. g. FIG. 2). That is, after being expanded, the stents 10 do not only hold themselves in place by fitting into their assigned vein but also be being sutured. This way, it may also be possible to attach the proximal end PE of a stent 10 at the transition between the SVC or IVC and the right atrium of a heart or at the wall of the right atrium itself The exact attachment point and technique can thus be chosen according to the different conditions at the different hearts which are being treated.

[0085] As one can see in FIGS. 1A, 1B and 2 the stents 10a and 10b can comprise different shapes in the expanded state. The reason for this lies in the fact that the different veins, namely the SVC and IVC, in which the stents 10 are supposed to be delivered, comprise different anatomies and/or conditions. Therefore, the shapes of the stents 10a and 10b are designed such that they fit best into their assigned vein.

[0086] Stent 10a of FIG. 1A, for example, is designed such that it fits in the vena cava superior SVC. It has shown that with a stent 10 shaped such that, in the expanded stat, the diameter of its middle part MP is bigger than the diameters of the proximal and distal ends PE, DE the best results can be achieved. One can also see that at a transition point between the middle part MP and the distal end DE the diameter of the stent decreases before increasing again. Furthermore, at the distal end DE the arms 14 are shaped such that they diverge, i.e. they point outwardly, to provide a good fitting behavior.

[0087] Additionally, due to anatomical reasons of the SVC, the skirt 18 of stent 10a does not only surround the proximal end PE of the stent 10a but also most of the middle part MP, i.e. up to ¾ of a length of the middle part, as well to prevent leakage between the stent 10a and the right atrium of the patient's heart.

[0088] Thus, the outer shape of the stent 10a can be described as follows: Starting at the proximal end PE of the stent 10a one can see that said end comprises eyelets 22, which have a rectangular outer shape with a rectangular opening therein, through which a thread for suturing the stent 10a to the SVC can be guided.

[0089] The proximal end PE comprises an essentially cylindrical shape, wherein the arms 14 of the frame 12 are connected such that they form a net with diamond-shaped openings. The middle part MP of the stent 10a is directly connected to the proximal end PE and comprises an essentially spherical outer shape. Thus, the diamond-shaped openings of the net formed by the arms 14 are bigger compared to the ones present at the proximal end PE.

[0090] At the other end of the middle part MP the stent 10a comprises its distal end DE, which again comprises a diameter that is smaller than the diameter of the middle part MP. Obviously, the diamond-shaped openings thus comprise an area which is smaller compared to the openings of the middle part MP.

[0091] The smaller the diameter of the distal end DE is, the smaller also the area of the openings is. At the very end of the distal end DE the arms 14 are faced outwardly in order to ensure a good interference fit of the stent 10a at the SVC.

[0092] The diameter of the distal end DE of the stent can be almost the same as the diameter of the proximal end PE of the stent 10a or can be significantly smaller (see FIG. 1A from left to right). Hence, the outer shape of the frame 12 of the stent 10a could be described as balloon-like. The ends of the arms 14 at both ends PE, DE of the stent 10a all lie in one plane.

[0093] In some embodiments also the distal end DE of the stent 10a can comprise eyelets 22 which can be formed in the same way as the eyelets of the proximal end PE. It is also possible that said distal eyelets comprise a different shape, e. g. a circular shape. The eyelets 22 extend from the plane in which the ends of the arms 14 lie.

[0094] A corresponding stent 10 for the placement inside the IVC is shown in FIG. 1B. It can be seen that the frame 12 of stent 10b, in the expanded state, is shaped such that the diameter of the stent generally increases from the proximal PE to the distal end DE of the stent 10b. At the middle part MP the stent 10b comprises a transition area TA where the diameter of the stent 10b increases significantly. It can be seen from FIG. 1B that the difference in diameter increase is even more significant the bigger the diameter in general is.

[0095] The skirt 18 of stent 10b only covers the proximal end PE of the stent 10b as well as small part of the middle part MP. As one can obviously see, the skirt 18 of stent 10b is significantly shorter than the one of stent 10a. This difference again arises due to the anatomical differences of the SCV and the IVC.

[0096] Thus, the outer shape of the stent 10b can be described as follows: Starting at the proximal end PE of the stent 10a can comprise eyelets 22, which can have a rectangular outer shape with a rectangular opening therein, through which a thread for suturing the stent 10a to the IVC can be guided. Said eyelets can also comprise another shape, i.e. for example a circular shape.

[0097] Furthermore, the proximal end PE comprises an essentially cylindrical shape, wherein the arms 14 of the frame 12 are connected such that they form a net with diamond-shaped openings.

[0098] Following the proximal end the stent 10b comprises a transition area TA at the middle part MP, where the arms 14 do not form diamond-shaped openings. Instead, the arms 14 are formed such that they are all parallel to each other. Said transition area can in some cases start precisely where the skirt 18 of the stent 10b terminates. In some embodiments the transition area TA can also be further away in a distal direction from said skirt 18. Nevertheless, the middle part MP of the stent 10a is directly connected to the proximal end PE.

[0099] The transition area TA extends over 5 to 20%, preferably over 8 to 15%, of the total length of the stent 10b, i.e. the region of parallel shaped arms 14 extends over 10 to 20% of the total length of the stent 10b, with the arms 14 extending in parallel to an axis A of the frame 12 (see FIG. 2). The axis A extends between the proximal and the distal end PE, DE of the frame 12 of the stent 10b.

[0100] At the transition area TA one can additionally see that the diameter of the middle part MP (and distal end DE) increases significantly compared to the diameter of the proximal end PE. Looking at FIG. 1B it can also be seen that the increase in diameter is even more significant the bigger the diameter is in the first place.

[0101] Also, following the transition area TA the arms 14 are again arranged netlike forming diamond-shaped openings. The area of said openings can be similar or smaller at the middle part MP and the distal end DE of the stent 10b compared to the area of the openings at the proximal end of the stent 10b (see FIG. 1B from left to right).

[0102] At the other end of the middle part MP the stent 10b comprises its distal end DE. The diameter of the stent 10b increases from the transition area TA to the distal end DE continuously. At the very end of the distal end DE the arms 14 are faced either straight downward (in a distal direction) or slightly outwardly in order to ensure a good interference fit of the stent 10b at the IVC. The ends of the arms 14 at both ends PE, DE of the stent 10b lie all in one plane.

[0103] In the embodiments shown in Fig, 1B also the distal end DE of the stent 10b comprises eyelets 22 having a rectangular outer shape with a rectangular opening for suturing the stent 10b to the IVC. Generally, the eyelets could also comprise a different shape, e. g. a circular shape. The eyelets 22 extend from the plane in which the ends of the arms 14 lie in.

[0104] FIG. 3 shows a delivery device 30 for the self-expandable stent 10 also known as a catheter. The delivery device 30 comprises a flush port 32 for flushing internal cavities of the delivery device (not shown) and a main body 34 for holding, inflating and/or releasing the stent 10. The device can further comprise two valved introducers (not shown) to allow access to the stent 10. Initially two diagnostic catheters (not shown) can be introduced via said two valved introducers together with the preloaded stent for delivering the stent to the target delivery site, i.e. the patients' heart.

[0105] The device further includes an actuation mechanism 38 for moving the stent 10 to a delivery site.

[0106] The main body 34 is arranged at an inner shaft at an end of the lumen 36 that extends between the actuation mechanism 38 and a tip 40 of the catheter 30. The stent 10 can thus be guided to the delivery site by the actuation mechanism 38 that has a torque control and can rotate the stent 10 about an axis A of the frame 12. The axis A extends between the proximal and the distal end PE, DE of the frame 12 of the stent 10.

[0107] The actuation mechanism 38 comprises a knob 42 at a distal end 48 of the actuation mechanism 38. On turning the knob 48 about an axis B of the actuation mechanism 38 which extends between the distal end 48 and a proximal end 50 of the actuation mechanism 38, the lumen 36 is able to deflect. This enables the tip 40 of the lumen 36 to occupy various positions (not shown). Such a deflection of the lumen 36 reduces the overall stress in the system which leads to a better positioning of the stent 10 at a delivery site and an overall improved accuracy of deployment of the delivery device 30 and hence of a stent 10 that is delivered to a delivery site using the delivery device 30.

[0108] On delivering the stent 10 to the delivery site, i.e. the heart, by the delivery device 30, the arterial femoral access is preferably used. The lumen 36 is then moved through the arteries to the heart.

[0109] The position of the stent 10, the diagnostic catheters and/or of the delivery device 30 can be tracked using e.g. x-rays in order to monitor radiopaque markings present at the stent 10 and/or the delivery device 30. Thereby the precision and accuracy during deployment of the stent 10 within the heart can be further increased, so that the replacement valve 16 can be positioned accurately at the aortic valve.

[0110] The invention is further defined by the following embodiments:

[0111] The invention relates to a self-expandable stent according to a first embodiment having a dry valve (16) made of bovine pericardium arranged at a proximal end (PE) thereof, a skirt (18) surrounding the dry valve (16) at the proximal end (PE) of the stent (10) and made of one of bovine pericardium and polyester, wherein the dry valve (16) is configured to be rehydrated when placed in contact with a solution, and the stent (10) comprising eyelets (22) arranged at the proximal end (PE) of the stent (10) for fixing the stent (10) at a point of interest, with the point of interest comprising one of the vena cava superior (SVC) and the vena cava inferior (IVC).

[0112] The self-expandable stent according to embodiment 2, which can include all features of embodiment 1, wherein the stent (10) comprises a distal end (DE) and a middle part (MP) arranged between the proximal end (PE) and the distal end (DE), and wherein the middle part (MP) is spaced approximately 20 to 40% from the distal end (DE) and approximately 20 to 40% from the proximal end (PE).

[0113] The self-expandable stent according to embodiment 3, which can include all features of embodiment 2, wherein the middle part (MP) extends over approximately 20 to 60% of a length of the stent (10).

[0114] The self-expandable stent according to embodiment 4, which can include all features of the preceding embodiments, wherein the stent (10) comprises a frame (12) composed of a plurality of arms (14) forming the three interconnected parts, i.e. the proximal end (PE), the distal end (DE) and the middle part (MP).

[0115] The self-expandable stent according to embodiment 5, which can include all features of embodiment 4, wherein, in the expanded state, the plurality of arms (14) is outwardly directed in the distal end (DE) of the frame (12).

[0116] The self-expandable stent according to embodiment 6, which can include all features of one of the preceding embodiments, wherein the frame (12) is composed of Nitinol.

[0117] The self-expandable stent according to embodiment 7, which can include all features of one of the preceding embodiments, wherein the stent (10) comprises a device or means (22) for attaching the proximal end (PE) of the stent (10) at the vena cava or at the transition between the vena cava and the right atrium of a heart.

[0118] The self-expandable stent according to embodiment 8, which can include all features of one of the preceding embodiments, wherein the dry bovine pericardium has a maximum tensile stress selected in the range of 15 to 25 MPa, and/or wherein the rehydrated bovine pericardium has a tensile stress selected in the range of 15 to 20 MPa.

[0119] The self-expandable stent according to embodiment 9, which can include all features of one of the preceding embodiments, wherein the dry bovine pericardium has a calcium content selected in the range of 0.01 to 0.1 g/Kg.

[0120] The self-expandable stent according to embodiment 10, which can include all features of one of the preceding embodiments, wherein the dry valve (16) comprises between two and six leaflets (20),

[0121] The self-expandable stent according to embodiment 11, which can include all features of one of the preceding embodiments, wherein the dry valve (16) comprises four leaflets (20).

[0122] The self-expandable stent according to embodiment 12, which can include all features of one of the preceding embodiments, wherein the dry bovine pericardium is formed by treating using a method comprising the following steps: [0123] (1) soaking of the bovine pericardium treated with a crosslinking agent with a saline solution; [0124] (2) contacting the soaked bovine pericardium with an aqueous solution comprising Hydrogen Peroxide; [0125] (3) contacting the bovine pericardium with an aqueous solution comprising PBS and EDTA; [0126] (4) contacting the bovine pericardium with a solution comprising glycerol, ethanol and EDTA; and [0127] (5) contacting the bovine pericardium with a glycerol solution.

[0128] The self-expandable stent according to embodiment 13, which can include all features of one of the preceding embodiments, wherein the stent (10) is configured to be placed in the vena cava superior (SVC).

[0129] The self-expandable stent according to embodiment 14, which can include all features of embodiment 13, wherein, in the expanded state, a maximum outer diameter of the middle part (MP) is larger than a maximum outer diameter of the proximal end (PE).

[0130] The self-expandable stent according to embodiment 15, which can include all features of embodiment 14, wherein a transition between the middle part (MP) and the distal end (DE) has an outer diameter that is less than the maximum outer diameter of the middle part (MP) and less than an outer diameter of the distal end (DE) in the expanded state.

[0131] The self-expandable stent according to embodiment 16, which can include all features of one of embodiments 13 to 15, wherein the skirt (18) surrounds at least the proximal end (PE) and parts of the middle part (MP) of the stent (10).

[0132] The self-expandable stent according to embodiment 17, which can include all features of one of embodiments 13 to 16, wherein the skirt (18) surrounds up to ¾ of a length of the middle part (MP).

[0133] The self-expandable stent according to embodiment 18, which can include all features of embodiments 13 to 17, wherein, in the expanded state, the maximum outer diameter of the distal end (DE) and a maximum outer diameter of the proximal end (PE) are generally the same.

[0134] The self-expandable stent according to embodiment 19, which can include all features of embodiment 18, wherein a difference between the maximum outer diameter of the distal end (DE) and the maximum outer diameter of the proximal end (PE) lies in the range of 0 to 10%.

[0135] The self-expandable stent according to embodiment 20, which can include all features of one of embodiments 13 to 19, wherein all of the ends of the arms (14) at the distal end lie in a common plane and can comprise eyelets (22).

[0136] The self-expandable stent according to embodiment 21, which can include all features of one of embodiments 1 to 12, wherein the stent (10) is configured to be placed in the vena cava inferior (IVC).

[0137] The self-expandable stent according to embodiment 22, which can include all features of embodiment 21, wherein, in the expanded state, a maximum out the diameter of the stent (10) generally increases from the proximal end (PE) to the distal end (DE).

[0138] The self-expandable stent according to embodiment 23, which can include all features of embodiments 21 and 22, wherein the skirt (18) surrounds at least the proximal end (PE) of the stent (10).

[0139] The self-expandable stent according to embodiment 24, which can include all features of embodiments 21 to 23, wherein the skirt (18) surrounds up to ¼ of a length of the stent (10).

[0140] The self-expandable stent according to embodiment 25, which can include all features of one of the preceding embodiments 21 to 24, wherein all of the ends of the arms (14) at the distal end (DE) lie in a common plane and can comprise eyelets (22).

[0141] The invention further relates to a set of stents according to a first embodiment comprising two self-expendable stents, both stents (10a, 10b) having a dry valve (16) made of bovine pericardium arranged at a proximal end (PE) thereof, a skirt (18) surrounding the dry valve (16) at the proximal end (PE) of the stent (10) and made of one of bovine pericardium and polyester, wherein the dry valve (16) is configured to be rehydrated when placed in contact with a solution, and eyelets (22) arranged at the proximal end (PE) of the stent (10) for fixing the stent (10) at a point of interest such as the vena cava superior (SVC) or inferior (IVC), wherein a first stent (10a) is configured to be placed in the vena cava superior (SVC), in particular according to embodiments 1 to 20 and a second stent (10b) is configured to be placed in the vena cava inferior (IVC), in particular according to embodiments 1 to 12 and 21 to 25.

[0142] The invention further relates to a device according to a first embodiment for delivering a self-expandable stent according embodiments 1 to 25, the delivery device (30) comprising a flush port (32); a main body part (34) for holding, inflating and/or releasing the stent; and an actuation mechanism (38) for moving the stent (10) to a delivery site.

[0143] The device according to embodiment 2, which can include all features of embodiment 1, wherein the actuation mechanism (38) has a torque control and can rotate the stent (10) about an axis (B) of the main body (34).

[0144] The device according to embodiment 3, which can include all features of embodiments 1 and 2, with the device (30) having a knob (42) or the like at the actuation mechanism (38), with the knob (42) in particular being able to be rotated about an axis of rotation (B) of the actuation mechanism (38).

[0145] The invention further relates to a method of deploying a stent according to embodiments 1 to 20 and/or a set of stents according to embodiment 21 with a device for delivering said stent according to embodiments 22 to 24 for orthotopic and/or heterotopic applications at locations in the proximity of the tricuspid valve.

[0146] The method according to embodiment 2, which can include all features of embodiment 1 comprising at least the following steps: [0147] providing at least one stent; [0148] inserting said stent into a vein of a human or animal body using the delivery device; [0149] moving said stent to an application site with said delivery device; and [0150] deploying said stent at the application site.