Implant encapsulation

• US 8,838,256 B2
• Filed: 07/26/2013
• Issued: 09/16/2014
• Est. Priority Date: 07/26/2012
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi, Mashiach, Itzik
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/952,106
• Publication Number:
  US 20140031915A1
• Time in Patent Office: 417 Days
• Field of Search: 607/132, 607/129, 607/126, 607/134
• US Class Current: 607/134
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36189 using modulation techniques
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: H02J 50/05 using capacitive coupling
• CPC Class Codes: H02J 50/12 of the resonant type
• CPC Class Codes: H04B 5/26 using coils
• CPC Class Codes: H04B 5/266 One coil at each side, e.g. with primary and secondary coils
• CPC Class Codes: H04B 5/72 for local intradevice communication
• CPC Class Codes: H04B 5/79 for data transfer in combination with power transfer
• CPC Class Codes: Y10T 29/49018 with other electrical component

Abstract

An implant unit may include a substrate and an implantable circuit arranged on the substrate. An encapsulation structure may be disposed over at least a portion of the substrate and at least a portion of the implantable circuit, the encapsulation structure including a parylene layer and a silicon layer disposed over the parylene layer.

Claims

1. An implantable device for treating sleep apnea, the device comprising:

a flexible substrate sized and shaped for supporting at least one pair of modulation electrodes and configured to lie between a myelohyoid muscle and a genioglossus muscle, the carrier further including a portion configured to lie between a geniohyoid muscle and the genioglossus muscle and configured to be implanted adjacent the genioglossus muscle;

an implantable circuit arranged on the substrate and coupled to electrodes configured to stimulate a hypoglossal nerve;

an encapsulation structure disposed over at least a portion of the substrate and at least a portion of the implantable circuit, the encapsulation structure including;

a first polymer layer having a first density; and

a second polymer layer disposed over the first polymer layer and having a density which is less than the first density.

2. The device of claim 1, wherein the first polymer layer includes parylene and the second polymer layer includes silicone.

3. The device of claim 2, wherein the parylene includes parylene C.

4. The device of claim 1, wherein the substrate comprises a flexible carrier.

5. The device of claim 1, further comprising an antenna encapsulated by the first polymer layer and the second polymer layer.

6. The device of claim 1, wherein the implantable circuit includes at least one meandering electrical trace configured to maintain electrical contact during flexing of the device.

7. The device of claim 1, further comprising the at least one pair of modulation electrodes connected to the implantable circuit, wherein the first polymer layer includes a first window of exposure over one or more of the modulation electrodes, the first window of exposure having a first area;

and

wherein the second polymer layer includes a second window of exposure over one or more of the modulation electrodes and at least partially extending over the first window of exposure, the second window of exposure having second area that is larger than the first area of the first window of exposure.

8. The device of claim 1, wherein the substrate includes at least one perforation, wherein the first polymer layer is disposed on a first side of the substrate and a second side of the substrate opposite to the first side, and wherein the second polymer layer is disposed on a first side of the substrate, on a second side of the substrate opposite to the first side, and through the at least one perforation.

9. The device of claim 1, further comprising at least one suture hole through the substrate and the second polymer layer and a surgical mesh disposed within the at least one suture hole, wherein the surgical mesh is encapsulated by the second polymer layer.

10. The device of claim 1, further comprising at least one suture hole through the substrate and the second polymer layer.

11. The device of claim 1, wherein the device has a thickness of less than 4 mm.

12. The device of claim 1, wherein the first polymer layer is deposited by chemical vapor deposition.

13. The device of claim 1, wherein a thickness of the first polymer layer is between 10 microns and 80 microns thick.

14. The device of claim 1, wherein the substrate includes a flexible carrier.

15. The device of claim 14, wherein the flexible carrier has a thickness of less than about 4 mm.

16. The device of claim 14, wherein the flexible carrier includes at least one of silicone, polyimides, phenyltrimethoxysilane, polymethyl methacrylate, Parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone, Liquid Crystal Polymer, or Kapton.

17. The device of claim 1, further including a third polymer layer disposed over the second polymer layer, wherein the third polymer layer has a density less than the second polymer layer.

18. The device of claim 17, wherein the third polymer layer includes parylene.