Percutaneous transluminal angioplasty device with integral embolic filter

• US 10,702,367 B2
• Filed: 07/17/2017
• Issued: 07/07/2020
• Est. Priority Date: 11/24/2004
• Status: Active Grant

• Current Assignee: Contego Medical, Inc.
• Original Assignee: Contego Medical, LLC
• Inventors: Sachar, Ravish, Patel, Udayan
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US15/651,429
• Publication Number:
  US 20170312069A1
• Time in Patent Office: 1,086 Days
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A percutaneous transluminal angioplasty device having an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon and downstream from the blockage to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure is performed. The embolic filter is normally collapsed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon is properly positioned, however, means operatively associated with the embolic filter are actuated to erect the filter to operatively position a filter mesh across the lumen of the vessel.

Claims

1. A percutaneous interventional treatment apparatus comprising:

an elongated catheter having a lumen, a proximal end portion, a distal end portion, an outer side wall, and a longitudinal axis;

a filter operably coupled to the distal end portion of the elongated catheter, wherein the filter is selectively collapsible and expandable about and between a collapsed position and a deployed position, and wherein the filter comprises;

a movable ring slidably coupled to the elongated catheter;

a fixed ring spaced from the movable ring relative to the longitudinal axis of the elongated catheter and immovably coupled to the elongated catheter,

a tubular frame comprising a first end coupled to the movable ring and an opposed second end coupled to the fixed ring, wherein the tubular frame further comprises;

a first plurality of longitudinal struts, each strut of the first plurality of longitudinal struts comprising a first end coupled to the fixed ring, and a second end extending toward the movable ring,

a second plurality of longitudinal struts, each strut of the second plurality of longitudinal struts comprising a first end coupled to the movable ring, and a second end extending toward the fixed ring,

a plurality of intermediate struts positioned between the first and second plurality of longitudinal struts, wherein a first side of a selected intermediate strut is coupled to the second end of a selected strut of the first plurality of longitudinal struts, and wherein a second side of the selected intermediate strut is coupled to the second end of a selected strut of the second plurality of longitudinal struts, and

a filter mesh or membrane directly attached at a first end to the plurality of intermediate struts, extending over an outer surface of the movable ring, and directly attached at a second end to the catheter, thereby forming a sac that retains embolic particles when the filter is in the collapsed position;

wherein selective movement of the movable ring towards the fixed ring causes at least a portion of the tubular frame to expand radially, thereby selectively expanding the filter towards the deployed position.

2. The percutaneous interventional treatment apparatus of claim 1, wherein the filter mesh or membrane fully covers either the second plurality of longitudinal struts.

3. The percutaneous interventional treatment apparatus of claim 1, wherein the filter mesh or membrane fully covers the plurality of intermediate struts.

4. The percutaneous interventional treatment apparatus of claim 1, wherein the filter mesh or membrane comprises a semi-compliant material or a thermoplastic elastomer.

5. The percutaneous interventional treatment apparatus of claim 4, wherein the filter mesh or membrane comprises of nylon, PebaxT, Pellathane, Tecothane, or Chronofles.

6. The percutaneous interventional treatment apparatus of claim 4, wherein the filter mesh or membrane comprises uniformly placed holes.

7. The percutaneous interventional treatment apparatus of claim 1, wherein the filter mesh or membrane is elastic such that when the tubular frame is expanded, the elasticity of the stretched filter mesh or membrane exerts a radially inward force that urges the tubular frame towards the collapsed position.

8. The percutaneous interventional treatment apparatus of claim 1, further comprising an interventional device attached to the catheter and spaced longitudinally from the filter.

9. The percutaneous interventional treatment apparatus of claim 1, wherein the filter is formed of a shape memory material having a shape memory that urges the filter towards the collapsed position.

10. The percutaneous interventional treatment apparatus of claim 1, further comprising an actuator wire extending through the lumen of the elongated catheter and having proximal and distal ends, wherein when the filter is in the collapsed position, pulling on the proximal end of the actuator wire exerts a longitudinal force on the movable ring that moves the movable ring longitudinally towards the fixed ring, and wherein the longitudinal movement of the movable ring causes at least a portion of the tubular frame to expand radially, thereby selectively expanding the filter towards the deployed position.

11. The percutaneous interventional treatment apparatus of claim 1, wherein each strut of the first plurality of longitudinal struts comprises at least one oval cutout, wherein the major axis of the at least one oval cutout is oriented transverse to the longitudinal axis of the strut of the first plurality of longitudinal struts, and wherein each strut of the second plurality of longitudinal struts comprises at least one oval cutout, wherein the major axis of the at least one oval cutout is oriented transverse to the longitudinal axis of the strut of the second plurality of longitudinal struts.

12. The percutaneous interventional treatment apparatus of claim 1, wherein the tubular frame further comprises a plurality of points of weakness, wherein the plurality of points of weakness comprise a plurality of regions of reduced cross-sectional area.

13. The percutaneous interventional treatment apparatus of claim 12, wherein each strut of the first plurality of longitudinal struts and each strut of the second plurality of longitudinal struts is coupled to the plurality of intermediate struts at a respective connection point, and wherein at least one point of weakness of the plurality of points of weakness is formed at a connection point between the plurality of intermediate struts and one of the first plurality of longitudinal struts or the second plurality of longitudinal struts.

14. The percutaneous interventional treatment apparatus of claim 12, wherein the first end of each of the first plurality of longitudinal struts is connected to the fixed ring at a first series of connection points, wherein the first end of each of the second plurality of longitudinal struts is connected to the movable ring at a second series of connection points, and wherein at least one point of weakness of the plurality of points of weakness is formed at connection point of the first series of connection points or the second series of connection points.

15. The percutaneous interventional treatment apparatus of claim 1, wherein the longitudinal struts of the second plurality of longitudinal struts are circumferentially offset with respect to the longitudinal struts of the first plurality of longitudinal struts in a plane substantially perpendicular to the longitudinal axis of the elongated catheter.

16. The percutaneous interventional treatment apparatus of claim 15, wherein the plurality of intermediate struts define a serpentine-like pattern.