Systems and methods for treatment of sleep apnea

• US 9,381,109 B2
• Filed: 05/28/2014
• Issued: 07/05/2016
• Est. Priority Date: 03/19/2010
• Status: Active Grant

• Current Assignee: ReVENT Medical, Inc.
• Original Assignee: ReVENT Medical, Inc.
• Inventors: Gillis, Edward M., Shadduck, John H.
• Primary Examiner(s): HAWTHORNE, OPHELIA ALTHEA
• Application Number:
  US14/289,475
• Publication Number:
  US 20140261451A1
• Time in Patent Office: 769 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

A system for revisably treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, first and second openings extend through first and second implant ends, respectively, for permitting a tissue plug to grow through each opening. Methods of using and revising such systems are also provided.

Claims

1. A method for treating an airway disorder comprising:

providing an implant body having first and second end portions configured to surround first and second spaced apart tissue plugs, respectively;

implanting the body in an airway-interface tissue;

applying tension between the tissue plugs with the implant body to draw the tissue plugs closer together to thereby alleviate tissue obstruction of the airway; and

cutting the first or second end portions to disengage the implant body from the airway-interface tissue.

2. The method of claim 1 where the implanting includes releasably maintaining the implant body in a tensioned configuration for a selected time interval.

3. The method of claim 2 wherein a portion of the implant body is releasably maintained in the tensioned configuration by a bioerodible or biodissolvable material.

4. The method of claim 3 wherein the bioerodible or biodissolvable material is carried about an exterior of the implant body.

5. The method of claim 3 wherein the bioerodible or biodissolvable material is carried within an interior portion of the implant body.

6. The method of claim 1 wherein the applying tension includes releasing the implant body from a tensioned configuration to move toward a non-tensioned configuration.

7. The method of claim 6 wherein the releasing comprises allowing the bioerodible or biodissolvable material to erode or dissolve.

9. The method of claim 1, wherein the first and second end portions of the implant body each comprise a loop, and wherein at least a portion of one of the loops has a higher modulus than that of a medial portion of the implant body to prevent deformation of the loop under tensioning forces.

10. The method of claim 1 where the first and second tissue plugs grow through the first and second end portions of the implant body, respectively, after the body is implanted.

11. The method of claim 1 where the first and second end portions are provided in the implant body in a releasably tensioned configuration, the releasably tensioned configuration being releasably maintained by a bioerodible or biodissolvable material carried by a medial portion of the implant body.

12. The method of claim 1 further including cutting said tissue plugs and extracting the implant from the tissue to revise treating.

13. The method of claim 1 further including extracting the implant body from the airway-interface tissue to revise treating.

22. The method of claim 9, wherein the least one of the loops comprise a proximal portion of a lower modulus material similar to a modulus of the medial portion of the implant body, and a terminal part having a higher modulus to prevent its deformation under tensioning forces.

8. A system for revisably treating an airway disorder, comprising:

an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site, the implant body having a medial portion,

first and second openings extending through first and second implant ends, respectively, for permitting each of the first and second implant ends to surround a tissue plug wherein the first and second implant openings are each formed by a flexible loop at either the first or the second implant end, said flexible loops adapted to surround the tissue plugs and to disengage the implant body from the airway-interface tissue site by releasing the surrounded tissue plugs after the flexible loops have been cut, wherein at least a portion of one of the flexible loops has a higher modulus than that of the medial portion to prevent deformation of the flexible loop under tensioning forces, wherein at least one of the flexible loops comprises a proximal portion of a lower modulus material similar to a modulus of the medial portion of the implant body, and a terminal part having a higher modulus to prevent its deformation under tensioning forces.

14. A system for revisably treating an airway disorder, comprising:

an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site, the implant body having a medial portion,

first and second openings extending through first and second implant ends, respectively, for permitting each of the first and second implant ends to surround a tissue plug wherein the first and second implant openings are each formed by a flexible loop at either the first or the second implant end, said flexible loops adapted to surround the tissue plugs and to disengage the implant body from the airway-interface tissue site by releasing the surrounded tissue plugs after the flexible loops have been cut, wherein at least a portion of one of the flexible loops has a higher modulus than that of the medial portion to prevent deformation of the flexible loop under tensioning forces.

15. The system of claim 14 further comprising a cutting element configured for removal of the implant body from the site.

16. The system of claim 15 wherein the cutting element comprises at least one of a pivotable blade edge, a rotatable sleeve with a blade edge, an axially translatable blade edge, and a cut wire.

17. The system of claim 14 wherein the medial portion is configured for implantation in the airway-interface tissue site in a non-repose condition.

18. The system of claim 17 wherein the medial portion is configured to be releasably maintained in the non-repose condition by a bioerodible or biodissolvable material carried by said medial portion.

19. The system of claim 14 wherein the first and second openings of the first and second implant ends are configured to allow the tissue plugs to grow therethrough after the implant body has been implanted in the airway-interface tissue site.

20. The system of claim 14 wherein the medial portion comprises an elastomeric material.

21. The system of claim 14, wherein the loops comprise an elastomeric material.