Aortic arch filtration catheter for carotid artery protection and methods of use

• US 10,682,217 B2
• Filed: 09/14/2017
• Issued: 06/16/2020
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: Lumen Biomedical, Inc.
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Ganesan, Kavitha, Ogle, Matthew F.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/704,196
• Publication Number:
  US 20180000577A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Filtration systems with integrated filter element(s) forming portions of the wall of the filtration catheter are disclosed. The filtration catheters disclosed herein are designed to be used alone or in conjunction with another filter device to provide embolic protection of both carotid arteries. Occlusive element such as balloon is placed on the exterior of the filtration catheter to redirect blood flow in the vessels during the filtration process as well as to help anchor the filtration catheter inside the vessel. The integrated filter element(s) does not require collapsing thus significantly reduces the complexity of the filtration system retrieval process and the chances of releasing emboli back into the blood stream. The compact design of the filtration systems makes them particularly suitable for embolic protection during endovascular procedures on or close to the heart.

Claims

1. A biocompatible filtration catheter comprising:

a shaft having a balloon lumen, a proximal end and a distal end;

a proximal port in fluid communication with the balloon lumen and connected to the proximal end of the shaft;

an integrated filter element having an inner flow lumen formed into a tubular section that replaces a section of a wall of the catheter at or near the distal end of the shaft, wherein the integrated filter element provides for fluid flow out from the catheter interior;

a distal section extending in a distal orientation from the integrated filter element and having a distal opening, wherein a tubular portion of the balloon lumen extends along the integrated filter element through the inner flow lumen from the shaft to the distal section;

a balloon having an interior in fluid communication with the balloon lumen and that is associated with the exterior of the distal section at or near the distal end of the distal section that can extend radially outward from the exterior of and around the circumference of the shaft; and

a conduit extending within the distal section from the distal opening to the inner flow lumen of the integrated filter element to provide fluid communication between the distal opening and the integrated filter element;

wherein the integrated filter element comprises interwoven polymer fibers, has an outer diameter approximately the same as the outer diameter of the shaft and extending around the entire circumference of the shaft and the tubular inner flow lumen and that is integrated as part of the wall of the catheter at or near the distal end of the shaft, and provides for fluid flow out from the catheter interior with a pore size designed to capture at least about 95% of emboli with a size greater than 100 microns, wherein the integrated filter element has structural stability;

wherein the integrated filter element having a length from about 10 mm to about 70 mm.

2. The filtration catheter of claim 1 wherein the integrated filter element further comprises metal filaments.

3. The filtration catheter of claim 1 wherein the interwoven polymer fibers comprise surface capillary fibers.

4. The filtration catheter of claim 1 wherein the integrated filter element has pore sizes of about 50 micron to about 500 micron.

5. The filtration catheter of claim 1 wherein the balloon has an extended configuration with a diameter suitable to occlude a human brachiocephalic artery.

6. The filtration catheter of claim 1 wherein the balloon comprises a compliant deformable material connected to the shaft to provide for inflation of the balloon.

7. The filtration catheter of claim 1 wherein the catheter has a diameter between about 5 Fr to about 7 Fr.

8. The filtration catheter of claim 1 further comprising a sheath slidably positioned over the catheter having a configuration extended in a distal direction relative to the catheter covering the integrated filter element.

9. The filtration catheter of claim 1 wherein the interwoven polymer fibers have a diameter from 5 microns to about 150 microns.