Tongue deformation implant

• US 10,531,979 B2
• Filed: 03/17/2014
• Issued: 01/14/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Fabian Hermann Urban Fuglister
• Original Assignee: Fabian Hermann Urban Fuglister
• Inventors: Fuglister, Fabian Hermann Urban
• Primary Examiner(s): Matthews, William H
• Application Number:
  US14/773,629
• Publication Number:
  US 20160022471A1
• Time in Patent Office: 2,129 Days
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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

There is provided a method and apparatus for a tongue implant to induce deformation of the tongue made of nickel titanium alloy in superelastic state at body temperature for the treatment of obstructive sleep apnea. In one embodiment the implant has a function of a V shaped spring, one leg helically inserted into the tongue, the other leg beneath the root of the tongue, to permanently compress the tongue. In another embodiment, there is provided a method and apparatus for placement of a helical implant to permanently compress the tongue by deforming it and stiffening it to maintain tongue stability for the treatment of obstructive sleep apnea.

Claims

1. An implant for treating obstructive airway disorders comprising an element forming a helix having a helix axis in a helical section of the implant wherein, at body temperature, the helical section is elastic and exhibits an oval shape as seen along the helix axis, such that, when implanted along a helically pierced pathway in the tongue, the implant compresses the tongue by a force directed toward the helix axis.

2. The implant of claim 1, wherein the element is adapted such that the force deforms the helically pierced pathway to an oval shape in a plane transverse to the helically pierced pathway.

3. The implant of claim 2, wherein the oval shape of the helically pierced pathway has a larger diameter directed along the coronal plane of the tongue.

4. The implant of claim 1, wherein the element in the helical section comprises compression portions and widening portions for producing the force towards the axis of the helix.

5. The implant of claim 4, wherein a cross section of the widening portions is smaller than a cross section of the compression portions.

6. The implant of claim 4, wherein the compression portions and widening portions alternate every quarter turn of the helical section.

7. The implant of claim 1, wherein the element in the helical section is shaped as a cone such that an end of the element to be inserted first has a smaller cross section than an opposite end of the element.

8. The implant of claim 7, wherein the element in the helical section is shaped as a profiled cone with alternate fibered parts having larger and smaller cross-sections.

9. The implant of claim 1, wherein the element comprises NiTi adapted to be in a superelastic state at body temperature.

10. The implant of claim 9, wherein the element comprises a NiTi wire having an elastomeric outer hull comprising a silicone rubber.

11. The implant of claim 10, wherein the silicone rubber is formed to increase the surface area perpendicular to the force exerted, in order to decrease a pressure at a given force on soft tissue.

12. The implant of claim 10, wherein the silicone rubber is protected with at least one of a fluoropolymer coating and a woven or braided fabric of a UHMWPE fiber.

13. The implant of claim 10, wherein the outer hull has wings.

14. The implant of claim 1, wherein the implant further comprises a flexible distal end section positioned adjacent the helical section.

15. The implant of claim 1, wherein the implant further comprises a torque-producing section and a force distributing section, wherein the torque producing section and force distributing section are adapted such that when implemented into a patient'"'"'s tongue the implant biases the tongue to return toward a second deformed shape without requiring tissue attachment.

16. The implant of claim 15, wherein the force distributing section is adapted for placement between the root of the tongue and the geniohyoid muscle, or is adapted for placement between the geniohyoid and the mylohyoid muscle.

17. The implant of claim 15, wherein the force distributing section is adapted to be attachable to the mandible bone for exerting a pulling force and/or is adapted to be attachable to the hyoid bone.

18. The implant of claim 15, wherein the force distributing section further comprises an axially compliant fin adapted to be placed between the two geniohyoid muscles thereby preventing dislocation.

19. The implant of claim 7, wherein the forces exerted vary along the implant member ranging between 0 and 25 kPa, variable through a defined variation in diameter of the implant.

20. The implant of claim 14, wherein the distal end of the flexible distal end section has a spherical shape or a conical shape.