MULTI-LAYER FILTRATION DEVICE

• US 20130046330A1
• Filed: 08/17/2011
• Published: 02/21/2013
• Est. Priority Date: 08/17/2011
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: McIntosh, Charles L., Kuppurathanam, Shyam, Melsheimer, Jeffry S.
• Granted Patent: US 8,617,200 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0023 differing in porosity

Abstract

A filter device assembly and a method of using such a device to capture and remove embolic material from a body lumen or blood vessel is provided. The filter device assembly generally comprises a structure having a collapsed state and an expanded state with first, second, and optionally N additional filter members circumferentially attached thereto. Each filter member forms an annulus chamber with the first filter member having porosity P₁; the second filter member circumferentially having porosity P₂; and the N additional filter members each having porosity [P₃ . . . P_(2+N)]. The magnitude of the porosity for the first, second, and N additional filter members follows the relationship P₁>[P₃> . . . >P_(2+N)]>P₂. The first, second, and N additional filter portions are configured in the expanded state to allow blood to flow there through and to capture emboli in the annulus chambers.

Claims

1. A filter device assembly for capturing embolic particles in a body vessel, the device comprising:

a structure having a frame with a predetermined shape, and a distal and proximal portion;

the frame being configured to move between an expanded state for engagement with the body vessel and a collapsed state for delivery and retrieval; and

at least a first and second filter member, each filter member having a proximal part and a distal part, the proximal part circumferentially attached to the distal portion of the structure;

the distal part of the first filter member closed such that the first filter member forms a first annulus chamber having porosity P₁ and the distal part of the second filter member closed such that the second filter member forms a second annulus chamber having porosity P₂;

wherein the magnitude of the porosity for the first and second filter members follows the relationship P₁>

P₂;

wherein the first and second filter members are configured in the expanded state to allow blood to flow there through and to capture emboli in the annulus chambers.

2. The filter device assembly of claim 1, wherein the porosity P₁ is at least about 150 micrometers and the porosity P₂ is equal to or less than about 50 micrometers.

3. The filter device assembly of claim 1, wherein the device assembly further comprises a middle portion, the middle portion arranged between the distal and proximal portions;

and

N additional filter members, wherein N is an integer greater than or equal to one;

each of the N additional filter members has a proximal part and a distal part, the proximal part circumferentially attached to the middle portion of the frame;

the distal part closed such that each N additional filter member forms an annulus chamber having a porosity [P₃ . . . P_(2+N)];

wherein the magnitude of the porosity for each filter member follows the relationship P₁>

[P₃>

. . . >

P_(2+N)]>

P₂.

4. The filter device assembly of claim 3, wherein the porosity of the first filter member, P₁, is at least about 150 micrometers, the porosity of the second filter member, P₂, is equal to or less than about 50 micrometers, and the porosity of each additional filter member, [P₃ . . . P_(2+N)], is greater than about 50 micrometers and less than about 150 micrometers.

5. The filter device assembly of claim 1, wherein the structure in its expanded state has a substantially cylindrical shape.

6. The filter device assembly of claim 3, wherein the distal end of each filter member is closed by being coupled to at least one of a shaft or an end hub.

7. The filter device assembly of claim 6, wherein the shaft includes perforated distal and proximal end sections;

the proximal end section acting as struts to provide support for one filter member.

8. The filter device assembly of claim 1, wherein the frame comprises one selected from the group of a metal, metal alloy, polymeric material, and combination thereof.

9. The filter device assembly of claim 1, wherein the proximal end of the frame engages a guide wire for use in deployment and retrieval of the filter device assembly from the body vessel.

10. The filter device assembly of claim 4, wherein each filter member comprises a material independently selected as one from the group of a non-woven material, a knit, a braid, a textile composite, a woven fabric, a molded polymer, a polymer film, or a combination thereof.

11. A method for providing embolic protection during treatment of a stenosis, occlusion, lesion, or other defect in a body vessel, the method comprising the steps of:

introducing a catheter into the body vessel;

locating the end of the catheter proximate to a target site;

placing a filter device assembly in the catheter;

the filter device assembly comprising;

a structure having a frame with a predetermined shape, and a distal and proximal portion;

the frame being configured to move between an expanded state for engagement with the body vessel and a collapsed state for delivery and retrieval; and

at least a first and second filter member, each filter member having a proximal part and a distal part, the proximal part circumferentially attached to the distal portion of the structure;

the distal part of the first filter member closed such that the first filter member forms a first annulus chamber having porosity P₁;

the distal part of the second filter member closed such that the second filter member forms a second annulus chamber having porosity P₂;

wherein the magnitude of the porosity for the first and second filter members follows the relationship P₁>

P₂;

deploying the filter device in the collapsed state into the body vessel past the stenosis, occlusion, lesion, or other defect; and

thereafter causing the device to move from the collapsed state to the expanded state; and

treating the stenosis, occlusion, lesion, or other defect;

wherein the first and second filter members of the filter device assembly are configured such that in the expanded state the filter portions allow blood to flow there through and to capture emboli in the annulus chambers.

12. The method of claim 11, wherein the method further comprises the step of withdrawing the catheter from the body vessel.

13. The method of claim 11, wherein the device assembly placed in the catheter further comprises a middle portion, the middle portion arranged between the distal and proximal portions;

and

N additional filter members, wherein N is an integer greater than or equal to one;

each of the N additional filter members has a proximal part and a distal part, the proximal part circumferentially attached to the middle portion of the frame;

the distal part closed such that each N additional filter member forms an annulus chamber having a porosity [P₃ . . . P_(2+N)];

wherein the magnitude of the porosity for each filter member follows the relationship P₁>

[P₃>

. . . >

P_(2+N)]>

P₂.

14. The method of claim 13, wherein the porosity P₁ in the first filter portion of the filter device assembly is at least about 150 micrometers;

the porosity P₂ in the second filter portion is equal to or less than about 50 micrometers; and

the porosity of each additional filter member, [P₃ . . . P_(2+N)], is greater than about 50 micrometers and less than about 150 micrometers.

15. The method of claim 14, wherein the first filter member allows emboli having a diameter larger than porosity, P₁, to be captured and emboli having a diameter smaller than porosity, P₁, to pass there through along with the flow of blood to the adjacent filter member.

16. The method of claim 15, wherein the second filter member allows emboli having a diameter larger than porosity, P₂, to be captured and emboli having a diameter smaller than the porosity, P₂, to pass there through along with the flow of blood.

17. The method of claim 14, wherein each additional filter member allows emboli having a diameter larger than the corresponding porosity, [P₃ . . . P_(2+N)], to be captured and emboli having a diameter smaller than the corresponding porosity, [P₃ . . . P_(2+N)], to pass there through along with the flow of blood to the adjacent filter member.

18. The method of claim 11, wherein the treating the stenosis, occlusion, lesion, or other defect includes one selected from the group of the deployment of a stent, deployment of a balloon, chemical dissolution, or mechanical thrombolysis.