Systems and methods for treatment of sleep apnea

• US 9,439,801 B2
• Filed: 06/29/2012
• Issued: 09/13/2016
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: ReVENT Medical, Inc.
• Original Assignee: ReVENT Medical, Inc.
• Inventors: Gillis, Edward M., Truckai, Csaba, Buscemi, Paul J.
• Primary Examiner(s): HAWTHORNE, OPHELIA ALTHEA
• Application Number:
  US13/539,081
• Publication Number:
  US 20140000631A1
• Time in Patent Office: 1,537 Days
• Field of Search: 128/848, 128859-862, 602/902, 433 6- 7, 600 29- 30, 600/216, 600/228
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Methods of maintaining airway patency in an airway of a patient. A method includes the steps of wrapping a bioerodable material at least partway around an axis to create a wound bioerodable implant, and coupling two points on the bioerodable material to each other. The invention also provides systems for maintaining airway patency in an airway of a patient that may be used with the methods.

Claims

1. An implant system for treating a sleep disorder comprising a bioerodable material and an elongate long term implant, wherein the bioerodable material at least partially envelops the elongate long term implant and resists a compressive force of the long term implant, the bioerodable material comprising a plurality of first regions having a first flexibility and a plurality of second regions having a second, flexibility that is less than the first flexibility.

2. The implant system of claim 1 wherein the bioerodable material comprises a spring having a plurality of coils and the first regions having the first flexibility comprise two coils of the spring.

3. The implant system of claim 2 wherein the second regions having the second, lesser flexibility comprise two points on the coils that are linked with each other.

4. The implant system of claim 1 wherein the second regions of lesser flexibility are configured to maintain the bioerodable material in an enveloping configuration relative to the elongate long term implant.

5. The implant system of claim 1 wherein the regions of lesser flexibility are configured to substantially hold the bioerodable material in an initial shape for a period of time that is less than 16 weeks upon exposure to a body fluid.

6. The implant system of claim 1 wherein the regions of lesser flexibility are configured to substantially hold the bioerodable material in an initial shape for a period of time between 2 and 6 weeks upon exposure to a body fluid.

7. The implant system of claim 1 wherein the regions of lesser flexibility are configured to substantially hold the bioerodable material in an initial shape for a period of time between 3 and 5 weeks upon exposure to a body fluid.

8. An implant system for implanting in airway forming tissue comprising a bioerodable material and an elongate long term implant, wherein the bioerodable material at least partially envelops the elongate long term implant and is linked between a first set of two points on the bioerodable material to form a first bridge, wherein the bioerodable material comprises a spring having a first set of at least two coils and a plurality of points, and the first bridge connects a first set of two points on the spring.

9. The implant system of claim 8 wherein the bioerodable material is linked between a second set of two points on a second set of coils of the spring to form a second bridge.

10. The implant system of claim 9 wherein the second set of coils is at a second end of the spring.

11. The implant system of claim 10 wherein substantially each coil is linked to at least one other coil to form a plurality of bridges.

12. The implant system of claim 9 wherein the first and second bridges are bioerodable.

13. The implant system of claim 8 wherein the two points are on different coils at a first end of the spring.

14. A method of manufacturing a bioerodable implant comprising the steps of:

wrapping a bioerodable material at least partway around an axis to create a wound bioerodable implant, the bioerodable material comprising two points along the bioerodable material; and

coupling the two points to each other.

15. The method of claim 14 wherein the axis comprises an elongate long term implant, and the wrapping around an axis comprises wrapping the bioerodable material around the elongate long term implant to create an implant system.

16. The method of claim 15 further comprising applying an expansive force to the elongate long term implant with the bioerodable material to thereby hold the long term implant in an initial shape.

17. The method of claim 14 wherein coupling comprises attaching a bioerodable material to the two points to create a support strut.

18. The method of claim 14 wherein coupling comprises applying at least one of an adhesive, an other chemical, or an energy source to the bioerodable material.

19. An implant system for treating a sleep disorder comprising a bioerodable material and an elongate long term implant, wherein the bioerodable material at least partially envelops the elongate long term implant and resists a compressive force of the long term implant, the bioerodable material comprising a first region having a first flexibility and a second region having a second flexibility, the first flexibility greater than the second flexibility, the greater flexibility caused by discontinuities in the first region.

20. The implant system of claim 19 wherein the bioerodable material comprises a polymer based on lactic acid.

21. The implant system of claim 20 wherein the bioerodable material comprises poly(lactic acid) or poly(DL-lactic-co-glycolic acid).

22. The implant system of claim 19 wherein the elongate long term implant comprises a silicone material.

23. An implant system for treating an airway disorder, comprising:

a resilient elongate implant body having a first insertion shape and a second therapeutic shape; and

a bioerodable material comprising two coils that at least partially envelop the resilient elongate implant body, wherein the coils are coupled together to form a coupled coil structure.

24. The implant system of claim 23 wherein the bioerodable material is configured to hold the implant body in the initial insertion shape.

25. The implant system of claim 24 wherein the bioerodable material comprises additional coils continuous with the two coils to thereby form a spring wherein the additional coils of the spring are wrapped around the implant body and the two coils are at an end of the spring.

26. The implant system of claim 25 wherein substantially each coil is coupled to at least one other coil.

27. An implant system for implanting in airway forming tissue comprising a bioerodable material and an elongate long term implant, wherein the bioerodable material at least partially envelops the elongate long term implant and is linked between a first set of two points along the bioerodable material to form a first bridge configured to limit radial expansion of the bioerodable material relative to the implant.

28. The implant system of claim 27 wherein the bioerodable material is configured to hold the elongate long term implant in an initial shape.

29. The implant system of claim 27 wherein the bioerodable material maintains the elongate long term implant in a tensioned initial shape.

30. A method of manufacturing an implant system, the implant having an elongate implant body and a bioerodable support material configured to hold the elongate implant body in a first, elongate shape, the method comprising the steps of:

wrapping the bioerodable support material at least partway around the implant body; and

coupling two points along the bioerodable material with each other to create a coupled bioerodable support material.

31. A method of manufacturing a bioerodable implant comprising the steps of:

wrapping a bioerodable material at least partway around an axis to create a wound bioerodable implant, the bioerodable material comprising two points; and

coupling the two points to each other, the coupling comprising heating the bioerodable material to thereby melt the two points together.

32. A method of manufacturing a bioerodable implant comprising the steps of:

wrapping a bioerodable material at least partway around an axis to create a wound bioerodable implant, the bioerodable material comprising two points; and

coupling the two points, wherein the wound bioerodable implant comprises a helix and the coupling comprises heating the helix to thereby fuse the two points.