MEDICAL KIT AND MEDICAL SYSTEM FOR THE TREATMENT OF ANEURYSMS

Abstract

The invention relates to a medical kit for the treatment of aneurysms, including a main catheter and a cover device for temporarily covering as aneurysm, which cover device can be moved through the main catheter to a place of treatment. The cover device includes a self-expanding lattice structure that has a cylindrical portion, open at a distal end and at least partially provided with a cover, and a funnel-type portion that is permanently connected to a transport wire, movable inside the main catheter, and a total lateral area of which is not covered so that when the lattice structure is expanded, blood can flow through it in the direction of its longitudinal axis. The invention further relates to a medical system.

Claims

1-20. (canceled)

21. A medical set for treatment of an aneurysm comprising: a main catheter; and a covering device adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm, the covering device including a self-expandable mesh structure having a cylindrical section that is open at a distal longitudinal end and at least partially provided with a covering, wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter, and wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure.

22. The medical set according to claim 21 wherein the covering is configured as an electrospun covering.

23. The medical set according to claim 21 wherein the covering is porous.

24. The medical set according to claim 21 wherein the covering has a negligible porosity that is impermeable to blood.

25. The medical set according to claim 21 wherein the covering has a porosity of at most 70%.

26. The medical set according to claim 21 wherein the covering has a porosity of at least 5%.

27. The medical set according to claim 21 wherein the covering extends over an entire circumference of the cylindrical section.

28. The medical set according to claim 21 wherein the covering extends over a portion of at most 50% of a circumference of the cylindrical section.

29. The medical set according to claim 21 wherein the covering extends over at least 80% of a length of the cylindrical section.

30. The medical set according to claim 21 wherein the covering extends over at most 80% of a length of the cylindrical section and wherein the covering is distanced from the distal longitudinal end of the cylindrical section.

31. The medical set according to claim 21 wherein the covering has at least 10 pores with a size of at least 15μm.sup.2 over an area of 100,000 μm.sup.2.

32. The medical set according to claim 21 wherein the covering is formed by a synthetic material.

33. The medical set according to claim 21 wherein the covering is disposed on one of an outside or an inside of the mesh structure.

34. The medical set according to claim 21 wherein the mesh structure is formed from webs which are connected together in one piece and which delimit closed cells.

35. A medical system for treatment of an aneurysm comprising: a main catheter; a covering device adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm, the covering device including a self-expandable mesh structure having a cylindrical section that is open at a distal longitudinal end and at least partially provided with a covering, wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter, and wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure; and at least one embolization means for placement in the aneurysm.

36. The medical system according to claim 35 further comprising: an additional catheter having a proximal region, a central region and a distal region, the additional catheter configured to deliver the embolization means into the aneurysm, wherein the additional catheter is one of independent of the main catheter or relatively movable with respect to the main catheter.

37. The medical system according to claim 36 wherein the central region of the additional catheter is disposed inside the covering device and the distal region of the additional catheter is disposed outside the covering device, and wherein the proximal region of the additional catheter is disposed parallel to the main catheter.

38. The medical system according to claim 36 wherein the proximal region of the additional catheter is disposed parallel to the main catheter and wherein the central and distal regions of the additional catheter are disposed outside of the covering device.

39. The medical system according to claim 36 wherein, in the expanded state, cells of the mesh structure one of (i) have an inscribed circle diameter or (ii) are expanded to the inscribed circle diameter, wherein the inscribed circle diameter at least corresponds to an external diameter of the additional catheter.

40. A medical system for treatment of an aneurysm comprising: a main catheter; a covering device adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm, the covering device including a self-expandable mesh structure having a cylindrical section that is open at a distal longitudinal end and at least partially provided with a covering, wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter, and wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure; and at least one embolization means for placement in the aneurysm, the embolization means formed by one of a plastically deformable wire or a liquid.

Description

[0049] Exemplary embodiments of the invention will now be described with the aid of the accompanying diagrammatic drawings. In the highly simplified drawings:

[0050] FIG. 1 shows a side view of a medical set in accordance with the invention in a first embodiment,

[0051] FIG. 2 shows a side view of a medical set in accordance with the invention in a second embodiment,

[0052] FIG. 3 shows a side view of a medical set in accordance with the invention in a third embodiment,

[0053] FIG. 4 shows a side view of a medical system in accordance with the invention in a first embodiment,

[0054] FIG. 5 shows a side view of a medical system in accordance with the invention in a second embodiment, and

[0055] FIG. 6 shows a scanning electron microscope image of a covering of a covering device of a set in accordance with the invention, in a preferred embodiment.

[0056] In the figures, parts with identical actions are always designated by the same reference numerals.

[0057] The medical set 2 shown in FIG. 1 is used for the treatment of aneurysms 4 and is shown in FIG. 1 in a state disposed inside a vessel 6.

[0058] The medical set 2 has a main catheter 8 as well as a covering device 12, which can is moveable through the main catheter 8 to a treatment site 10. The treatment site 10 is preferably a site along the length of the vessel 6 at which the aneurysm 4 is located. The covering device 12 is used for temporarily covering the aneurysm 4, wherein the covering device 12 comprises a self-expandable mesh structure 14. The mesh structure 14 is preferably produced from a shape memory material. Furthermore, the mesh structure 14 has a cylindrical section 16. The cylindrical section 16 is open in configuration at a distal longitudinal end 18. Furthermore, at least a portion of the cylindrical section 16 is provided with a covering 20.

[0059] FIG. 1 shows a first embodiment of the medical set 2, in which the covering 20 in particular extends over at least 90% and in particular over 100% of the length L of the cylindrical section 16. In addition, in the exemplary embodiment in accordance with FIG. 1, the covering 20 extends over the entire circumference or the entire circumferential surface of the cylindrical section 16.

[0060] Furthermore, the mesh structure 14 has a funnel-shaped section 22, which is formed at a proximal longitudinal end 24 of the mesh structure 14, i.e. in the direction of the main catheter 8.

[0061] Furthermore, the funnel-shaped section 22 and therefore the mesh structure 14 are permanently mechanically connected to a transport wire 26 displaceable inside the main catheter 8. By means of this transport wire 26, in a non-expanded state, the mesh structure 14 and therefore the covering device 12 can be advanced and retracted through the main catheter 8.

[0062] Furthermore, the funnel-shaped section 22 is free from a covering over the entire circumferential surface 27, preferably formed by the mesh structure 14 alone, so that in the expanded state, the mesh structure 14 is perfusible by blood in the longitudinal axial direction, i.e. in and against a direction of flow F.

[0063] In particular, the mesh structure 14 is disposed inside the vessel 6 in a manner such that the covering 20 is positioned at a level with an opening 28 of the aneurysm 4 so that the latter is covered by the covering 20, and at the same time, a flow of blood through the vessel 6 is not stopped. The covering 20 in the exemplary embodiment of FIG. 1 is therefore substantially tubular in configuration, in particular in the manner of a hollow cylinder.

[0064] In this regard, the covering 20 is preferably porous in configuration and perfusible by blood, so that a supply of nutrients is ensured to the cells covered by the covering 20. Alternatively, however, the covering 20 may also have negligible porosity or be impermeable and therefore fluid-tight, and in particular not perfusible by blood.

[0065] In this regard, in particular when an embolization means 40 is being placed (see FIG. 4 or FIG. 5) inside the aneurysm 4, the covering 20 is used so that after placement, the embolization means 40 cannot escape from the aneurysm 4 until the blood inside the aneurysm 4 has been clotted because of the embolization means 40 and therefore the aneurysm 4 has been effectively occluded.

[0066] In the exemplary embodiment in accordance with FIG. 1 and in all of the embodiments below, the covering 20 is formed as an electrospun covering 20.

[0067] The covering 20 may furthermore be disposed on an outside and/or on an inside 32 of the mesh structure 14. The mesh structure 14 furthermore has webs 34 or is formed from them, wherein the webs 34 are connected together in one piece, i.e. monolithically and delimit closed, in particular diamond-shaped cells 36. When the medical set 2 is placed inside the vessel 6, the blood therefore flows through the cells 36 and is not blocked. As already described, the webs 34 may also have respective web pairs with different web widths in order to increase the flexibility of the mesh structure 14. This configuration of the web pairs with different web widths is not unique to this exemplary embodiment in accordance with FIG. 1, and is therefore not limited thereto. In fact, all of the exemplary embodiments described in the context of this application may have web pairs configured as described above.

[0068] FIG. 2 shows a diagrammatic representation of the medical set 2 in accordance with the invention according to a second embodiment.

[0069] The second embodiment corresponds to the first embodiment, which is described in FIG. 1, in its essentials and in respect of the main catheter 8, the mesh structure 14 as well as the transport wire 26. What is essential for the second embodiment is that here, the covering 20 extends over only a portion, in particular over at most 80%, in particular over at most 60% and especially particularly over at most 40% of the length L of the cylindrical section 16.

[0070] This means that when the covering device 12 is in position, the covering 20 is only within the region of the opening 28 of the aneurysm 4, so that cells and/or side vessels bordering the aneurysm 4 are not covered by the covering 20. In this manner, the cells and/or the side vessels can still be supplied with blood and therefore with nutrients because the mesh structure 14 is formed with cells 36.

[0071] FIG. 3 diagrammatically shows a third embodiment of the medical set 2 in accordance with the invention. In similar manner to the description regarding the second exemplary embodiment, in this case only the differences pertaining to the covering 20 will be described, because all of the other embodiments, preferably in their entirety, in particular substantially, correspond to the embodiment in accordance with FIG. 2 or the embodiment in accordance with FIG. 1. This is particularly the case for the configuration of the main catheter 8, the transport wire 26 as well as the configuration of the mesh structure 14.

[0072] In accordance with the third embodiment, the covering 20 extends over only a portion of the circumference of the mesh structure 14 and only over a portion of the length L of the mesh structure 14. In particular in this case, the covering 20 extends in particular over at most 50%, in particular over at most 40% or in particular over at most 30% of the circumference of the cylindrical section 16 of the mesh structure 14.

[0073] By means of the third embodiment, a supply to cells and/or side vessels adjacent to the aneurysm 4 is furthermore optimized, because here, preferably, only the opening 28 of the aneurysm 4 is covered and also, cells and/or side vessels which are at the same level as the aneurysm 4 can still be supplied with blood and nutrients. In this manner, for example, a side vessel which is disposed opposite to the aneurysm 4 can be supplied with blood.

[0074] As can readily be seen in FIGS. 1 to 3, the medical set 2 and in particular the mesh structure 14 is provided with radiographic markers 56. The radiographic markers 56 are disposed at cell tips of the edge cells 36 of the mesh structure 14. Specifically, the radiographic markers 56 are formed as radiopaque sleeves, for example produced from platinum or gold, which are crimped onto the cell tips of the edge cells 36.

[0075] Furthermore, because of the expandability of the mesh structure 14 and also because of the porous configuration of the covering 20, the covering device 12 is configured for use with a main catheter 8, which is configured as a microcatheter.

[0076] In addition, it should be noted that the embodiments cited above, in particular as regards the extent of the covering along a length L of the mesh structure 14 and as regards the extent of the covering 20 along a circumference of the mesh structure 14 may be configured and combined in any way. Thus, for example, a configuration is also possible in which the covering 20 extends over the entire length L of the mesh structure, but however, only extends over a portion of the circumference of the mesh structure 14.

[0077] FIG. 4 shows a diagrammatic view of a medical system in accordance with the invention according to a first embodiment.

[0078] In this regard, the medical system comprises the aforementioned medical set 2 with the main catheter 8 as well as the covering device 12, which has the mesh structure 14 and the covering 20. The configuration of the covering 20 corresponds here to the aforementioned second embodiment.

[0079] Furthermore, the medical system has an embolization means which, for example, is formed by a plastically deformable wire 42 or by a liquid. The embolization means is placed inside the aneurysm 4 by means of an additional catheter 44, which is also part of the medical system.

[0080] The additional catheter 44 has a proximal region 46, a central region 48 as well as a distal region 50.

[0081] In order to place the embolization means 40, in accordance with the first embodiment of the medical system, the additional catheter 44 is disposed substantially parallel to, i.e. alongside the medical set 2 inside the vessel 6. In this regard, the additional catheter 44 and in particular the distal region 50 is “pushed” into the aneurysm 4 between a vessel wall and the covering 20 in order to place the embolization means 40 in the form of the plastically deformable wire 42 (also known as a “coil”) in it. During this and also afterwards, the covering 20 prevents the embolization means 40 from escaping from the aneurysm 4, for example because of the flow of blood.

[0082] FIG. 5 diagrammatically shows a second embodiment of the medical system. The only difference here is in the disposition of the additional catheter 44 upon placement of the embolization means 40 inside the aneurysm 4 or into the aneurysm 4.

[0083] In accordance with the second embodiment, the proximal region 46 of the additional catheter 44 is fed substantially parallel to, i.e. alongside the main catheter 8, while the central region 48 is fed through the covering device 12 and in particular through the mesh structure 14 into the interior of the mesh structure 14. This can in particular happen because the inscribed circle diameter D of the cells 36 of the mesh structure 14 in the expanded state corresponds to at least the external diameter A of the additional catheter 44 (not shown here to scale).

[0084] In this way, the additional catheter 44 and in particular the central region 48 can easily be introduced into the mesh structure 14. Furthermore, the distal region 50 passes through and out of the mesh structure 14 and inside the aneurysm 4. In addition, the distal region 50 of the additional catheter 44 is also fed through the covering 20. During and after placement of the embolization means 40 in the aneurysm 4, in the medical system in accordance with the second embodiment as well, the covering 20 prevents escape of the embolization means 40 from the aneurysm 4.

[0085] The construction of the covering 20 can easily be seen in the scanning electron microscope image of FIG. 6. This shows that the covering 20 has a plurality of pores 52 of irregular sizes, which are respectively delimited by filaments 54. The electrospinning process forms a plurality of filaments 54, which are orientated in an irregular manner with respect to each other. In this way, the pores 52 are formed. FIG. 6 also shows that the pores 52 have a comparatively small pore size, wherein some pores 52, however, are sufficiently large to ensure blood perfusion, for example. Specifically, four pores 52 in FIG. 6 have been highlighted; they are more than 30 μm.sup.2 in size. The density of the pores 52 that are more than 30 μm.sup.2 in size indicates that the covering has at least 10 pores 52 of this type over an area of 100,000 μm.sup.2.

[0086] FIG. 6 also shows that the filaments 54 of the covering cross over each other multiple times. However, a particular feature of the electrospinning process is that in the covering 20, sites are present at which exclusively two, i.e. no more than two, filaments 54 intersect. It is clear from this that the wall thickness of the covering 20 is very small and it is therefore very flexible.

[0087] The high flexibility of the covering 20 in combination with the high flexibility of the mesh structure 14 ensures that a covering device 12 can be produced which can be introduced into a (blood) vessel 6 through very small delivery catheters. In particular, delivery catheters may be used which have a size of 6 French, in particular at most 5 French, in particular at most 4 French, in particular at most 3 French, in particular at most 2 French. Specifically, the covering device in accordance with the exemplary embodiments described here may be used in catheters which have an internal diameter of at most 1.6 mm, in particular at most 1.0 mm, in particular at most 0.7 mm, in particular at most 0.4 mm.

[0088] In particularly preferred variations, the layer thickness of the covering 20 is at most 10 μm, in particular at most 8 μm, in particular at most 6 μm, in particular at most 4 μm. In this regard, at most 4, in particular at most 3, in particular at most 2 filaments 54 intersect. In general, inside the electrospun structure of the covering 20, points of intersection are provided in which only 2 filaments 54 intersect. Preferably, the mesh structure 10 has a cross sectional diameter of between 2.5 mm and 8 mm, in particular between 4.5 mm and 6 mm.

LIST OF REFERENCE NUMERALS

[0089] 2 medical set [0090] 4 aneurysm [0091] 6 vessel [0092] 8 main catheter [0093] 10 treatment site [0094] 12 covering device [0095] 14 mesh structure [0096] 16 cylindrical section [0097] 18 distal longitudinal end [0098] 20 covering [0099] 22 funnel-shaped section [0100] 24 proximal longitudinal end [0101] 26 transport wire [0102] 27 circumferential surface [0103] 28 opening of aneurysm [0104] 30 outside [0105] 32 inside [0106] 34 webs [0107] 36 cell [0108] 40 embolization means [0109] 42 deformable wire [0110] 44 additional catheter [0111] 46 proximal region [0112] 48 central region [0113] 50 distal region [0114] 52 pore [0115] 54 filaments [0116] 56 radiographic marker [0117] A external diameter [0118] D inscribed circle diameter [0119] F direction of flow [0120] L length