Catheter System for Delivery of a Filling Body to an Aneurysmal Sac in a Body Lumen

Abstract

The invention relates to a catheter system for delivery of a filling body to an aneurysmal sac in a body lumen, which catheter system includes a substantially tubular shaft having a proximal end, a distal end and a guidewire lumen extending between the proximal and distal ends; a substantially tubular sheath defining an interior volume, coaxially positioned over the tubular shaft and slidable relative to the tubular shaft; a compressible filling body arranged in a compressed state in the interior volume between the sheath and the shaft near the distal end of the tubular shaft; and where the compressible filling body is expandable, when released from the sheath, to a porous filling body having a substantially cylindrical lumen and an outer surface having a main dimension perpendicular to the longitudinal axis of the cylindrical lumen, which main dimension is at least 1.5 times the diameter of the cylindrical lumen.

Claims

1. A catheter system for delivery of a filling body to an aneurysmal sac in a body lumen, which catheter system comprises: a substantially tubular shaft having a proximal end, a distal end and a guidewire lumen extending between the proximal and distal ends; a substantially tubular sheath defining an interior volume, coaxially positioned over the tubular shaft and slidable relative to the tubular shaft; a compressible filling body arranged in a compressed state in the interior volume between the sheath and the shaft near the distal end of the tubular shaft; wherein the compressible filling body is expandable, when released from the sheath, to a porous filling body having a lumen, preferably substantially cylindrical, and an outer surface having a main dimension perpendicular to the longitudinal axis of the lumen, which main dimension is at least 1.5 times the diameter of the main dimension, perpendicular to the longitudinal axis, of the lumen.

2. The catheter system according to claim 1, wherein the outer surface is non-cylindrical, preferably bulbous shaped, ellipsoidal or spheroid.

3. The catheter system according to claim 1, wherein a stent is arranged in the lumen of the filling body.

4. The catheter system according to claim 1, wherein the material of the filling body has an open cell structure, preferably of a shape memory polymer or other memory material.

5. The catheter system according to claim 4, wherein the material of the filling body is a non-isotropic 3D printed foam with a structure similar to cancellous and cortical fibres.

6. The catheter system according to claim 1, wherein the filling body is composed out of a plurality of thrombogenic wires arranged to a body core in which the substantially cylindrical lumen is provided.

7. The catheter system according to claim 1, wherein the diameter of the circumscribing circle of the non-cylindrical outer surface in a plane perpendicular to the longitudinal axis of the lumen is between 2 cm and 10 cm.

8. The catheter system according to claim 1, wherein the filling body is coated with a hemostatic coating, such as fibrinogen, fibrin or collagen or another coating promoting aneurysm sac remodeling.

9. The catheter system according to claim 1, wherein the lumen of the filling body is flared on at least one, preferably both ends to facilitate cannulation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] These and other features of the invention will be elucidated in conjunction with the accompanying drawings.

[0042] FIG. 1 shows a cross-sectional view of an embodiment of the catheter system according to the invention in a first state.

[0043] FIG. 2 shows the catheter system of FIG. 2 in a second state.

[0044] FIG. 3 shows a perspective view of the filling body of the catheter system according to FIG. 1.

[0045] FIG. 4 shows a cross-sectional view of the filling body of FIG. 3.

[0046] FIGS. 5A-5D show different steps of a method for deploying the catheter system of FIG. 1.

DESCRIPTION OF THE INVENTION

[0047] FIG. 1 shows a cross-sectional view of a catheter system 1 according to the invention. The catheter system 1 has a tubular shaft 2, through which a guide wire 3 extends. A tubular sheath 4 defining an interior volume 5 is coaxially positioned over the tubular shaft 2.

[0048] A compressible filling body 6 is arranged in a compressed state in the interior volume 5 near the distal end of the tubular shaft 2.

[0049] FIG. 2 shows the catheter system 1 in a partially deployed state. The sheath 4 is retracted relative to the shaft 2, such that the compressible filling body 6 is partially pushed out of the interior volume 5, such that the filling body 6 is allowed to expand.

[0050] FIG. 3 shows the filling body 6 in fully expanded state. The filling body 6 has a bulbous outer surface 7 with a cylindrical lumen 8 extending through the filling body 6.

[0051] FIG. 4 shows a cross-sectional view of the filling body 6. A nitinol stent 9 is arranged in the cylindrical lumen 8, which has a diameter of D1. This nitinol stent 9 expands together with the porous filing body when the filling body 6 is moved out of the internal volume 5. The filling body 6 has a bulbous shape and a main dimension of D2, which is at least 1.5 times larger than the diameter D1.

[0052] Instead of a bulbous shape, the filling body could also have a more cylindrical or even fully cylindrical shape. Relevant is that there is sufficient material available between the cylindrical lumen and the outer surface, in which porous material thrombus forming and organization can occur in order to further fill the aneurysmal sac.

[0053] FIGS. 5A-5D show the abdominal aorta 10 with an abdominal aortic aneurysm 11, renal arteries 12 and common iliac arteries 13.

[0054] The catheter system 1 is introduced into the abdominal aorta 10 in a known way. The filling body 6 is pushed out of the internal volume 5, such that the filling body 6 expands into the abdominal aortic aneurysm 11. (see FIG. 5A en 5B). Upon expansion, the nitinol stent 8 also expands (see FIG. 5B) such that a cylindrical lumen is provided in the filling body 6. (see FIG. 5C)

[0055] The cylindrical lumen formed by the nitinol stent 8 allows for a pass-through opening through the abdominal aortic aneurysm 11, which is now completely filled with the porous filling body 6.

[0056] This pass-through opening can now be used to position a common prosthesis 14 into the abdominal aorta 10.