Device for maintaining patent paranasal sinus ostia

• US 9,192,490 B2
• Filed: 09/25/2014
• Issued: 11/24/2015
• Est. Priority Date: 07/30/2007
• Status: Active Grant

• Current Assignee: Audubon Technologies, LLC
• Original Assignee: Audubon Technologies, LLC
• Inventors: Hepworth, Edward J., Kashiwa, Corey B., Tyrrell, Steven P.
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US14/496,763
• Publication Number:
  US 20150081032A1
• Time in Patent Office: 425 Days
• Field of Search: 606/191, 606/194, 606/196, 606/199, 606/108, 623/1.11, 623/1.13, 623/1.15, 623/1.19, 623/10
• US Class Current: 1/1
• CPC Class Codes: A61F 2/186 Nose parts
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

There is disclosed a method for maintaining a patent paranasal sinus ostium. In an embodiment, the method includes delivering a tubular element in an insertion state to the sinus ostium. The tubular element includes a proximal end, a distal end, and a center region between the proximal end and distal end. The method includes expanding the tubular element from the insertion state to a deployment state when located in the sinus ostium. In the deployment state, the center region confronts the sinus ostium with an outward radial force.

Claims

1. A method for maintaining a patent paranasal sinus ostium, the method comprising:

delivering a tubular element in an insertion state to the sinus ostium, wherein the tubular element includes a proximal end, a distal end, and a center region between the proximal end and distal end; and

expanding the tubular element from the insertion state to a deployment state when located in the sinus ostium by partially melting the tubular element to allow reshaping of the tubular element from the insertion state to the deployment state, wherein, in the deployment state, the center region confronts the sinus ostium with an outward radial force.

2. The method of claim 1, wherein the delivering step comprises:

inserting a directional sheath into a nasal cavity;

inserting a guidewire through the directional sheath and into a sinus cavity via the sinus ostium;

inserting a catheter through the directional sheath over the guidewire, wherein the catheter includes a balloon that is disposed within a lumen of the tubular element; and

positioning the tubular element in the sinus ostium.

3. The method of claim 2, wherein the expanding step comprises:

inflating the balloon to expand the tubular element from the insertion state to the deployment state.

4. The method of claim 1, wherein the delivering step comprises:

positioning the tubular element around an elastomeric member connected to first and second holding members of an insertion device; and

positioning the tubular element in the sinus ostium with the insertion device.

5. The method of claim 4, wherein the expanding step comprises:

actuating the insertion device in a first direction to translate the second holding member toward the first holding member to expand the elastomeric member.

6. The method of claim 5, and further comprising:

actuating the insertion device in a second direction to translate the second holding member away from the first holding member to contract the elastomeric member to facilitate release of the tubular element from the insertion device.

7. The method of claim 1, wherein the expanding step comprises:

expanding the tubular element such that the center region has a radius that is less than a radius of at least one of the proximal end and the distal end.

8. The method of claim 1, wherein the partially melting step further comprises:

cooling of the tubular element in-situ at the sinus ostium so as to allow the tubular element to provide the outward radial force from the tubular element to counteract a constant centripetal force of scar tissue formation during healing of the sinus ostium.

9. A method for maintaining a patent paranasal sinus ostium, the method comprising:

delivering a tubular element in an insertion state to the sinus ostium, wherein the tubular element includes a proximal end, a distal end, and a center region between the proximal end and distal end;

expanding the tubular element from the insertion state to a deployment state when located in the sinus ostium by partially melting the tubular element to allow reshaping of the tubular element from the insertion state to the deployment state; and

providing a constant outward radial force from the tubular element to the sinus ostium, wherein, in the deployment state, the center region is configured to confront the sinus ostium with the constant outward radial force to counteract a constant centripetal force of scar tissue formation during healing of the sinus ostium.

10. The method of claim 9, wherein the expanding step further comprises:

leaving the tubular element in place in conformation to a given geometry of surrounding tissue of the sinus ostium.

11. A method for maintaining a patent paranasal sinus ostium, the method comprising:

delivering a tubular element in an insertion state to the sinus ostium, wherein the tubular element includes a proximal end, a distal end, and a center region between the proximal end and distal end; and

expanding the tubular element from the insertion state to a deployment state when located in the sinus ostium, wherein, in the deployment state, the center region confronts the sinus ostium with an outward radial force;

wherein the delivering step comprises;

positioning the tubular element around an elastomeric member connected to first and second holding members of an insertion device; and

positioning the tubular element in the sinus ostium with the insertion device;

wherein the expanding step comprises;

actuating the insertion device in a first direction to translate the second holding member toward the first holding member to expand the elastomeric member.

12. The method of claim 11, and further comprising:

actuating the insertion device in a second direction to translate the second holding member away from the first holding member to contract the elastomeric member to facilitate release the tubular element from the insertion device.