Device for maintaining patent paranasal sinus ostia

• US 8,303,640 B2
• Filed: 07/29/2008
• Issued: 11/06/2012
• 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): Jackson, Gary
• Assistant Examiner(s): Shipley, Amy
• Application Number:
  US12/181,416
• Publication Number:
  US 20090036968A1
• Time in Patent Office: 1,561 Days
• Field of Search: 606/191, 606/192, 606/199, 623/1.11, 623/1.19, 623/1.23
• US Class Current: 623/1.11
• 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

A device for maintaining a patent paranasal sinus ostium includes a tubular element having a proximal end, a distal end, and a center region between the proximal end and distal end. The tubular element has an insertion state and a deployment state. The tubular element is locatable in the sinus ostium when in the insertion state and expandable from the insertion state to the 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 system comprising:

a stent locatable in a sinus ostium when in an insertion state and conformable from the insertion state to a deployment state when located in the sinus ostium; and

a device configured to deliver the stent into the sinus ostium, the device comprising;

a handle including an actuation mechanism;

a shaft having a proximal end and a distal end, wherein the shaft proximal end is coupled to the handle;

a wire extending through the shaft having a proximal end and distal end, wherein the wire proximal end is operatively connected to the actuation mechanism;

a first holding member coupled to the shaft distal end;

a second holding member coupled to the wire distal end; and

a longitudinally compressible, radially expanding elastomeric member coupled to the first holding member at a first end and to the second holding member at a second end, the longitudinally compressible, radially expanding elastomeric member including an elastomeric member having a radial thickness forming a through-bore in a longitudinal direction sized to slidingly receive the wire, the elastomeric member selectively compressible between the first end and the second end to expand a diameter of the longitudinally compressible, radially expanding elastomeric member, the stent being positionable around the elastomeric member of the longitudinally compressible, radially expanding elastomeric member, wherein actuation of the actuation mechanism in a first direction translates the second holding member toward the first holding member to compress the elastomeric member, which in turn acts to expand the diameter of the longitudinally compressible, radially expanding elastomeric member such that, when the stent is positioned around the elastomeric member of the longitudinally compressible, radially expanding elastomeric member, the stent expands to the deployment state and the elastomeric member is configured to shape the stent to impart an hourglass conformation, and wherein actuation of the actuation mechanism in a second direction translates the second holding member away from the first holding member to uncompress the elastomeric member, which in turn acts to contract the diameter of the longitudinally compressible, radially expanding elastomeric member such that, when the stent is positioned around the expansile solid of the longitudinally compressible, radially expanding elastomeric member, the stent in the deployment state is released from the insertion device.

2. The system of claim 1, further comprising:

a sleeve formed in a center region of the longitudinally compressible, radially expanding elastomeric member between the first and second ends, wherein the sleeve is configured to cause the elastomeric member of the longitudinally compressible, radially expanding elastomeric member to expand less in the center region than proximate the first and second ends when the actuation mechanism is actuated in the first direction, resulting in the placement of the stent into an exaggerated hourglass conformation in a paranasal sinus bony ostium and a removeable status of the insertion device.

3. The system of claim 2, wherein, in the deployment state, the elastomeric member of the longitudinally compressible, radially expanding elastomeric member shapes the stent in a substantially hourglass shape.

4. The system of claim 1, wherein the shaft includes a shapeable region proximate the first holding member, the shapeable region comprised of at least one of a shape memory material and a malleable, curveable material.

5. The system of claim 4, wherein the shapeable region is substantially straight.

6. The system of claim 4, wherein the shapeable region is angled.

7. The system of claim 1, and further comprising:

a heating assembly configured to heat the elastomeric member of the longitudinally compressible, radially expanding elastomeric member to partially melt the stent when the elastomeric member of the longitudinally compressible, radially expanding elastomeric member is expanded.

8. The system of claim 7, wherein the heating assembly comprises:

a heating assembly power supply; and

a heating element coupled between the heating assembly power supply and the wire.

9. The system of claim 1, wherein expansion of the longitudinally compressible, radially expanding elastomeric member shapes the stent to maintain a patent paranasal sinus ostium.

10. An insertion device configured to position a sinonasal stent in a sinus ostium, the insertion device comprising:

a stent locatable in a sinus ostium when in an insertion state and conformable from the insertion state to a deployment state when located in the sinus ostium;

an insertion device instrument having a proximal end and a distal end in opposition to one another, and an actuation mechanism adjacent the proximal end of the insertion device;

a stent delivery portion having a proximal end and a distal end in opposition to one another, the stent delivery portion in operable connection with the insertion device instrument, and the stent delivery portion having an insertion position and a deployment position selectively configurable by the actuation mechanism of the insertion device instrument; and

a longitudinally compressible, radially expanding elastomeric member in operable connection with the stent delivery portion, the elastomeric member selectively compressible with the stent delivery portion at the deployment position to expand a diameter of the longitudinally compressible, radially expanding elastomeric member, wherein the actuation mechanism is configured to selectively compress the elastomeric member, which in turn acts to expand the diameter of the longitudinally compressible, radially expanding elastomeric member at the deployment position while reducing its length and the elastomeric member is configured to shape the stent to impart an exaggerated hourglass conformation, and wherein the actuation mechanism is configured to selectively uncompress the elastomeric member, which in turn acts to contract the diameter of the longitudinally compressible, radially expanding elastomeric member at the insertion position.