Stent for maintaining patency of a body region

• US 7,647,931 B2
• Filed: 03/20/2008
• Issued: 01/19/2010
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Quiescence Medical, Inc.
• Original Assignee: Quiescence Medical, Inc.
• Inventors: Pflueger, D. Russell, Thompson, Christopher Paul
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US12/052,540
• Publication Number:
  US 20080167725A1
• Time in Patent Office: 670 Days
• Field of Search: 128/848, 128/858, 128/206.11, 128/206.12, 128/206.18, 128/206.27, 128/207.13, 128/207.18, 606/199, 606/204, 606/204.45, 623/1.14, 623/1.15, 623/1.18, 623/1.19, 623/1.21, 623/1.22
• US Class Current: 128/848
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/203 comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

An apparatus and method for maintaining patency of a vessel or other body region is provided. The apparatus includes an appliance having a non-circumferential form and being effective in maintaining patency or openness, or causing to become patent or open, a body region in which the appliance is located. The appliance may be formed of a flexible metallic struts structured to be submucossally implanted into a wall of the vessel or other body region.

Claims

1. An apparatus for maintaining patency of a vessel or other region of a human or animal body, the apparatus comprising:

an appliance comprising a continuous loop including a body portion and rounded end portions spaced apart by the body portion, the body portion comprising two spaced apart elongated elements extending between the end portions such that the loop defines an open interior space between the space apart elongated elements,

the appliance being structured to take on a deployed configuration when located within the vessel or other body region, such that the end portions are spaced apart from each other by other than the body portion, the end portions overlap each other, or the end portions directly contact each other, and

the appliance being further structured to exert a force on the vessel or other body region, when the appliance is in the deployed configuration within the vessel or other body region, in order to maintain the region substantially open or unobstructed, or to cause the region to be maintained substantially open or unobstructed.

2. The apparatus of claim 1 wherein the appliance is structured to form a relatively flat configuration.

3. The apparatus of claim 1 wherein the appliance is configured and structured to be submucosally implanted into the vessel or other body region defines a substantially flat oblong configuration when in other than the deployed configuration.

4. The apparatus of claim 1 wherein the appliance comprises a super-elastic material.

5. The apparatus of claim 1 wherein the appliance comprises Nitinol.

6. The apparatus of claim 1 wherein the end portions are radiused.

7. The apparatus of claim 1 wherein the appliance comprises a plurality of struts extending along a substantial portion of the length.

8. The apparatus of claim 7 wherein said plurality of struts comprise a super-elastic material.

9. The apparatus of claim 7 wherein said plurality of struts comprise Nitinol.

10. The apparatus of claim 1 wherein the appliance comprises at least about 2 struts structured to be spaced apart from one another when implanted in the vessel or other body region.

11. The apparatus of claim 10 wherein the struts are sized and structured to be submucosally implanted in a vessel.

12. The apparatus of any of claim 11 wherein struts are sized and structured to be implanted in the vessel such that the struts are aligned along a longitudinal axis defined by the vessel.

13. The apparatus of claim 1 wherein the appliance comprises a cuff-shaped member having an outer peripheral portion defining an interior space.

20. The apparatus of claim 1, wherein the appliance has a length along the body portion between the end portions that is greater than a width of the body portion, the appliance configured to be deployed within the vessel or other body region such that the length is oriented circumferentially around the vessel or other body region in a C-shaped configuration and the width is oriented along the vessel or other body region.

14. A method for maintaining patency or causing to become patent, open or unobstructed, a body region of a human or an animal using, a flat or pre-curved member comprising a single continuous loop having a body portion and end portions spaced apart by the body portion, the body portion comprising elongated elements extending between the end portions such that the loop defines an open interior space between the space apart elongated elements, the method comprising:

pulling the end portions of the flat or pre-curved member together to form a folded configuration;

holding or temporarily securing the end portions together;

placing the member in the folded configuration, into a body region to be treated; and

releasing the end portions from being held or secured together, thereby allowing the member to expand within the body region.

15. The method of claim 14 wherein the expanded member within the vessel or other body region is effective to provide a substantially constant radial force against the walls or tissues of the body region.

16. A method for maintaining patency or causing to become patent, open or unobstructed, a vessel of a human or animal, the method comprising the steps of:

providing an elongated member having a desired stiffness and resiliency, the elongated member comprising a loop including first and second end portions and two spaced apart elongated elements extending between the first and second end portions such that the loop defines an interior space between the spaced apart elongated elements,

implanting the elongated member at least partially submucosally into walls of the vessel.

17. An apparatus for treating at least one of sleep apnea and snoring, comprising:

an appliance comprising a single continuous loop comprising first and second end portions and two spaced apart elongated elements extending between the first and second end portions such that the loop defines an open interior space between the spaced apart elongated elements, the appliance being sized for introduction into an oropharyngeal region of a human or animal and deployable in a C-shaped deployed configuration in which the elongated elements extending generally laterally across the posterior wall and the first and second end portions bearing against and providing an opening force against the lateral walls of the oropharyngeal region.

18. The apparatus of claim 17, further comprising a needle for pulling the elongated member into the mucosal layer adjacent the oropharyngeal region.

19. The apparatus of claim 17, wherein the loop is structured to form a pre-curved configuration having a diameter of curvature larger than the diameter of curvature of the oropharyngeal region.