Transluminal angioplasty devices and methods of use

• US 9,968,472 B2
• Filed: 10/27/2016
• Issued: 05/15/2018
• Est. Priority Date: 10/27/2015
• Status: Active Grant

• Current Assignee: Contego Medical, Inc.
• Original Assignee: Contego Medical, LLC
• Inventors: Sachar, Ravish, Serina, Eugene
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US15/336,242
• Publication Number:
  US 20170112647A1
• Time in Patent Office: 565 Days
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0017 differing in yarn density
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A percutaneous transluminal angioplasty device includes a catheter defining one or more lumens. A filter is coupled to the catheter adjacent a distal end of the catheter, and the filter is movable between an unexpanded and expanded configuration via a filter activation wire that extends through a lumen. An expandable balloon is coupled to the catheter proximally of the filter, and a stent is disposed over at least a portion of the balloon. To deploy the stent to a target site, the filter is first moved into its expanded position via the filter activation wire. Then, the stent is expanded, and the balloon is inflated to expand the stent further radially. The balloon is then deflated, the filter is contracted, and the catheter, balloon, and filter are removed from the body.

Claims

1. A percutaneous transluminal angioplasty device, comprising:

a multi-lumen catheter having a proximal portion and a distal portion, the catheter defining a first lumen, a second lumen, and a third lumen, each lumen extending through at least a portion of the catheter;

a filter disposed adjacent the distal end of the catheter and being movable between unexpanded and expanded configuration, the filter comprising a filter frame formed of a shape memory material having a memory of the unexpanded configuration;

a filter activation wire disposed within the first lumen, wherein a distal end of the filter activation wire is coupled to the filter frame, and wherein tensioning the filter activation wire urges the filter frame in an axial direction from an unexpanded configuration to an expanded configuration;

an expandable balloon disposed on the catheter at a location proximal to the filter;

a self-expanding stent extending over at least a portion of the expandable balloon; and

a movable sheath extending over at least a portion of the self-expanding stent;

a sheath wire coupled to the movable sheath, the sheath wire extending through one of the lumens defined by the catheter, wherein movement of the sheath wire translates the sheath axially; and

a handle coupled to a proximal end of the catheter, wherein the handle comprises a first actuation knob coupled to the filter activation wire and being manipulatable to expand and contract the filter via the filter activation wire, and wherein the handle further comprises a second actuation knob coupled to the sheath wire and being manipulatable to axially move the sheath via the sheath wire.

2. The percutaneous transluminal angioplasty device of claim 1, wherein the self-expanding stent is constrained in place over at least a portion of the balloon by the movable sheath and expands in response to the movable sheath being moved axially away from the self-expanding stent.

3. The percutaneous transluminal angioplasty device of claim 1, wherein the sheath wire is moved axially to translate the sheath axially, and wherein the axial movement of the sheath wire translates the sheath in the same direction as the axial movement of the sheath wire.

4. The percutaneous transluminal angioplasty device of claim 1, wherein:

the filter further comprises a filter membrane,

the filter frame has a distal end and a proximal end, the proximal end of the filter frame being fixedly coupled to the catheter, and the distal end of the filter frame being slidably coupled to the catheter,

the filter membrane has a distal end and proximal end, and the distal end of the filter membrane is fixedly coupled to the catheter distally of the proximal end of the filter membrane and the distal end of the filter frame, and the proximal end of the filter membrane is fixedly coupled to a portion of the filter frame, and

the distal end of the filter activation wire is coupled to the distal end of the filter frame, wherein tensioning the filter activation wire in a proximal direction urges the distal end of the filter frame in axial proximal direction from an unexpanded configuration to an expanded configuration.

5. The percutaneous transluminal angioplasty device of claim 1, wherein the third lumen is a balloon inflation lumen, the catheter further defining an inflation port between an external surface of the catheter and the third lumen.

6. The percutaneous transluminal angioplasty device of claim 1, wherein the catheter defines a guidewire port, the guidewire port having a first opening defined by one of the first, second, or third lumen and a second opening defined by an exterior surface of the catheter, wherein the first opening of the guidewire port is disposed distally relative to the second opening.

7. The percutaneous transluminal angioplasty device of claim 6, wherein a guide wire is disposed within at least a portion of the first, second, or third lumen that defines the first opening of the guidewire port.

8. The percutaneous transluminal angioplasty device of claim 1, wherein at least a portion of the filter has a radius in the expanded configuration that corresponds to an inner diameter of a blood vessel into which the filter is disposed.

9. The percutaneous transluminal angioplasty device of claim 1, wherein the first lumen is a balloon inflation lumen, wherein the second lumen is an filter activation wire lumen, and wherein the third lumen is an sheath wire lumen and/or a guidewire lumen.

10. The percutaneous transluminal angioplasty device of claim 9, wherein the proximal portion of the catheter comprises a proximal balloon inflation lumen and the distal portion of the catheter comprises a distal balloon inflation lumen, and wherein the proximal balloon inflation lumen and the distal balloon inflation lumen are axially aligned.

11. The percutaneous transluminal angioplasty device of claim 9, wherein the proximal portion of the catheter comprises a proximal filter activation wire lumen and the distal portion of the catheter comprises a distal filter activation wire lumen, and wherein the proximal filter activation wire lumen and the distal filter activation wire lumen are axially aligned.

12. The percutaneous transluminal angioplasty device of claim 9, wherein the proximal portion of the catheter comprises a proximal sheath wire lumen and the distal portion of the catheter comprises a distal guidewire lumen, and wherein the proximal sheath wire lumen and the distal guidewire lumen are axially aligned.

13. The percutaneous transluminal angioplasty device of claim 1, wherein the self-expanding stent comprises a plurality of circumferentially arranged rings that are axially spaced apart, the rings having a sinusoidal pattern around a circumference of each ring, and each ring being coupled to an axially adjacent ring by one or more axially elongated struts.

14. The percutaneous transluminal angioplasty device of claim 13, wherein:

the self-expanding stent has a first end, a second end, a central portion, and a longitudinal axis extending between the first and second ends,

a diameter of the central portion is less than a diameter of the first end and a diameter of the second end, and

a diameter of the self-expanding stent increases parabolically from the central portion toward each end.

15. The percutaneous transluminal angioplasty device of claim 13, wherein the elongated struts are arranged in an s-pattern, and the elongated struts in a first row have a first orientation, the elongated struts in a second row adjacent to the first row have a second orientation, and the first orientation and the second orientation are mirror images of each other.

16. The percutaneous transluminal angioplasty device of claim 13, wherein each elongated strut is coupled between offset and opposing apexes of the sinusoidal pattern of adjacent ring segments such that the elongated strut extends around a portion of the circumference of the self-expanding stent.