A SELF EXPANDING FLOW DIVERSION DEVICE WITH ENHANCED KINK RESISTANCE AND RADIAL STRENGTH

Abstract

A flow diverter device is used to redirect the blood flow inside the cerebral blood vessels and for the reduction of blood flow to the aneurysm, hence preventing the chance of aneurysm rupture as well as promoting the healing of the aneurysm. The novel design of the device, using a set of thicker wires, provides high kink resistance and radial strength. Two patterns of inter-braiding the thicker set of wires with the finer braid are disclosed, one having a checker-board and the other a ring structure. Both patterns are highly kink resistant with the checker-board design providing minimal loss in flexibility, whereas the ring design provides greater radial strength. The device could be made of super elastic materials like Nitinol wires with the thicker set being radio opaque. The device is highly kink resistant and sufficiently flexible for use in vasculature with complex bends.

Claims

1. A self expanding flow diversion device with enhanced kink resistance and radial strength employed in an arterial lumen, the said device comprising; a set of cells, each bounded by four thicker wires (101, 110, 112, 113) and each of said cells consisting of finer wires (groups 103, 104, 105, 106, 107, 108, 115, 116) braided together, wherein the tubular device formed by repeating these cells in the axial as well as circumferential directions; characterized in that, the thicker set of wires (101, 110, 112, 113) disposed within one cell, one portion of each thick wire being configured above and the other portion (102, 109, 111, 114) below the finer set of wires (103, 104, 105, 116, 106, 115, 107, 108) making X-shaped crossing of a pair of thick wires disposed fully on the inner side or the outer side of the fine braid when the next crossing of the thicker wire is on the opposite side of the fine braid forming a checker-board pattern, wherein, the said self expanding flow diversion device having the checker board pattern enhances the kink resistance and radial strength of the braid with minimal loss in flexibility.

2. A self expanding flow diversion device with enhanced kink resistance and radial strength employed in an arterial lumen, the said device comprising; a set of cells, each bounded by four thicker wires (201, 202, 207, 208) and each cell consisting of finer wires (groups 203, 204, 205, 206) braided together, wherein the tubular device is formed by repeating these cells in the axial as well as circumferential directions; characterized in that, the upper bounds of the cell formed by two thick wires disposed above (201, 202) and lower bounds of the cell below (207, 208) the finer set of wires (203, 204, 205, 206) forming a continuous zig-zag circumferential ring of thicker wires is on one side of the fine braid, and the neighboring such rings are on the opposite side of the fine braid, forming a ring pattern, wherein, the said self-expanding flow diversion device having the ring pattern enhances the kink resistance and radial strength.

3. The self expanding flow diversion device as claimed in claim 1, wherein, all or a portion of the thicker wires (101, 110, 112, 113) are made radio-opaque by any of the below said procedures; (a.) coating it with radio-opaque materials, (b.) replacing it with radio-opaque wires, (c.) replacing it with tubes filled with radio-opaque material.

4. The self expanding flow diversion device as claimed in claim 1, wherein the thicker wire has a diameter 1.5 to 4 times the diameter of the finer wire wherein the thicker wires are configured to resist deformation in the cross section of the flow diverter causing a better kink resistance and radial strength to be achieved even at a smaller radius of curvature.

5. The self expanding flow diversion device as claimed in claim 1, wherein the reinforcement of finer diameter wires with the thicker wires provides higher radial strength with high kink resistance throughout the cross section of the device.

6. The self expanding flow diversion device as claimed in claim 2, wherein, all or a portion of the thicker wires (201, 202, 207, 208) are made radio-opaque by any of the below said procedures; (a.) coating it with radio-opaque materials, (b.) replacing it with radio-opaque wires, (c.) replacing it with tubes filled with radio-opaque material.

Description

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0014] FIG. 1: shows the unfolded structure of the invented device with checker-board pattern.

[0015] FIG. 1A: shows the unit cell of the checker-board pattern.

[0016] FIG. 2: shows the unfolded structure of another embodiment of the invented device with ring pattern.

[0017] FIG. 2A: shows the unit cell of the ring pattern.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

[0018] The present invention of the flow diverter device has a novel braiding pattern using two sets of wires in which the second set has thicker wire with higher stiffness. The wires used for braiding could be of Nitinol, which is superelastic and can recover its shape from large strains. The invention could be manufactured by conventional braiding process using a mandrel of suitable diameter and geometry. By changing the number of wires, braid angle and thickness of the wires (stiffer wire with flexural rigidity; here after mentioned as thicker wire), the porosity can be varied as per the requirement for flow diversion. The thicker wires are braided together with the finer wires in an interleaved fashion, wherein the thicker wires passes over a multiplicity of finer wires which are braided continuously, on one side before crossing over to the other side of the finer wires.

[0019] The present invention with the checker-board pattern when unfolded and laid flat horizontally:

[0020] has braided cells containing thicker (stiffer) and finer wires, where in four thicker wires forms the boundary of the cell, which enclose and crosses the finer wire in a checker-board pattern, characterized in that for the thicker set of wires within one cell, one-half of a single thick wire is above (and the other half below) the finer set of wires, so that the crossings of the thicker wires which are X-shaped are completely on one side of the fine braid forming the checker-board pattern;

[0021] has a symmetric array of rhomboidal cells, where each cell in both the circumferential as well as axial directions, is a replication of the adjacent cell.

[0022] Another embodiment of the present invention, with the ring pattern when unfolded and laid flat horizontally:

[0023] has braided cells containing thicker (stiffer) and finer wires, where in four thicker wire forms the boundary of the cell, which enclose and crosses the finer wire in ring pattern, characterized in that the upper sides of the cell are above (and lower sides of the cell below) the finer set of wires, so that a continuous zig-zag ring of thicker wires is on one side of the fine braid forming the ring pattern;

[0024] has a symmetric array of rhomboidal cells, where each cell in both the circumferential as well as axial directions, is a replication of the adjacent cell.

[0025] In the present invention, the tubular structure of flow diverters employs two different wire diameters. The thicker wire can have a diameter of 1.5 to 4 times the diameter of the finer wire and the thicker wire overlaps the finer wire in either a checkerboard or ring pattern to achieve higher kink resistance and higher radial strength. The thicker wire resists the deformation in the cross-section of the flow diverter so that even at smaller radius of curvature better kink resistance and radial strength can be achieved. The thicker wires are lesser in number and can also be made radio-opaque or be replaced with radio opaque wires. Radio opaque materials like gold, platinum, tantalum, iridium or their alloys can be used to form these wires, and utilize methods for incorporating radio opaque materials into the flow diverter such as chemical deposition, edge coating, sputtered deposition and vapor deposition to name a few. Further these larger set of wires could be a tube of any elastic material such as nitinol and be filled with any radio-opaque material such as platinum.

[0026] The finer wires are braided so as to get a low porosity throughout the surface of the flow diverter. The reinforcement of finer diameter wires with the thicker wires provides the higher radial strength with high kink resistance throughout the cross section of the device.

[0027] The shape setting of the device for a specific configuration is done with heat treatment which is well known in the art for shape memory alloys.

[0028] Two novel patterns for inter braiding the set of thicker wires with the set of finer wires are disclosed here and termed (i) checker-board and (ii) ring. For the checker-board pattern (FIG. 1 and FIG. 1A), the thicker wire is diamond (1×1) braided and finer diameter wire is braided in a regular (2×2) pattern. Throughout the surface the thicker wire crosses above and below half the number of the finer wires inside a cell forming a checker-board pattern, and hence the name checker-board design. The said checker-board pattern and the reinforcement of thicker wires in the said pattern enhance kink resistance and minimal loss of flexibility to the invented flow diverter device. The loss of flexibility is minimized by having the crossings of the thicker wire fully on one side of the finer braid so that the sliding of the thicker wires on each other is minimally restricted.

[0029] The thick lines (101, 110, 112 and 113) show the larger diameter wire, crossing above half the number of finer wires (103, 108, 115 and 105 respectively) as in FIG. 1A. The thick dotted lines (102, 109, 111 and 114) show the larger diameter wire crossing beneath half the number of finer wires (104, 107, 106 and 116 respectively) as in FIG. 1A. Thus the checker-board pattern of the device is obtained.

[0030] In a second embodiment of the invention, another pattern (FIG. 2 and FIG. 2A) termed Ring is used, where the thicker wire is diamond braided and finer wire is braided in 2x2 pattern, and each thicker wire is crossing above and below all the finer wire in a unit cells forming a ring pattern, hence the name ring design. The said ring pattern and the reinforcement of thicker wire in the said ring pattern enhance kink resistance and radial strength to the invented flow diverter device.

[0031] The thick line (201 and 202) shows the larger diameter wire crossing above all the finer wires (203 and 205 respectively) as in FIG. 2A. The thick dotted line (207 and 208) shows the larger diameter wire crossing below all the finer wire (204 and 206) as in FIG. 2A. Thus the Ring pattern of the device is obtained. Since the finer braid and the thicker braid intersect at the crossings of the thicker wires the sliding of the thicker wires on each other is reduced leading to an increased radial strength, however at the cost of an increased loss of flexibility.

[0032] In the present invention, for both designs of the device, the thicker set is a diamond braid whereas the finer set is a regular braid. The pattern of braid within the sets could be varied to any braiding pattern such as diamond, regular or hercules.

[0033] An empirical relation for finding the number of wires used for braiding a flow diverter is:

N=n×M+M

Where,

[0034] M=Number of thicker wires

[0035] n=Number of finer wires across one thicker wire within a single cell.

[0036] N=Total number of wires used in braiding

The number of wires ‘n’ could vary from 4 to 32 and ‘M’ could vary from 4 to 16. The number of wires used for braiding ‘n’ depends on the required porosity of the device and ‘M’ on the required radial strength as well as kink resistance.