Implant holder and suture guide

• US 9,511,238 B2
• Filed: 07/26/2013
• Issued: 12/06/2016
• Est. Priority Date: 07/26/2012
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/952,082
• Publication Number:
  US 20140031840A1
• Time in Patent Office: 1,229 Days
• Field of Search: 132/323, 132/327, 606/139, 606148-151, 606/157, 606/228
• US Class Current: 1/1
• 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

A delivery system is disclosed having an implant retainer configured to releasably hold an implant unit and maintain the implant unit in a fixation location relative to target tissue in a subject'"'"'s body during an implantation procedure. A first suture guide portion may be disposed on a first side of the implant retainer and configured to guide a suture needle during the implantation procedure. A second suture guide portion may be disposed on a second side of the implant retainer, opposite the first side, and configured to guide the suture needle after the suture needle exits the first suture guide portion.

Claims

1. A device for delivering a sleep apnea related implant to a location proximate a genioglossus muscle, the device comprising:

an implant retainer configured to releaseably hold an implant configured for implantation adjacent an genioglossus muscle and maintain the implant in a fixation location relative to target tissue beneath skin in a region between a neck and a chin of a subject during an implantation procedure, the implant including a first extension of an elongate arm having a first perimeter and a second extension of an elongate arm having a second perimeter,

the implant retainer including;

a first jaw having a first face and a first protruding portion extending from the first face at a periphery of the first face, wherein the first protruding portion is configured to accept and surround at least a portion of the first perimeter of the first extension when the first extension lies against the first face, and

a second jaw having a second face and a second protruding portion extending from the second face at a periphery of the second face, wherein the second protruding portion is configured to accept and surround at least a portion of the second perimeter of the second extension when the second extension lies against the second face,

a first suture guide portion disposed on a first side of the implant retainer and configured to guide a suture needle through a first suture hole in the retained implant and a first portion of a genioglossus muscle during the implantation procedure; and

a second suture guide portion disposed on a second side of the implant retainer opposite the first side and configured to guide the suture needle through a second suture hole in the retained implant and a second portion of a genioglossus muscle after the suture needle exits the first suture guide portion, wherein the second suture guide portion includes an arcuate channel.

2. The device of claim 1, wherein the implant retainer includes an implant holder and a handle connected to the implant holder, and wherein the first and second suture guides are associated with the implant holder.

3. The device of claim 2, wherein a space between the first jaw and the second jaw is adjustable, and the implant holder includes a ratchet mechanism configured to maintain a desired variable spacing between the between the first jaw and the second jaw.

4. The device of claim 3, wherein the arcuate channel extends from a distal end of the first jaw toward the handle.

5. The device of claim 1, wherein the implant is configured to assume an arc shape relative to the implant retainer, wherein the first suture guide portion is positioned on the implant retainer in a location providing access to the first suture hole on the implant unit proximate to a first end of the arc, wherein the second suture guide portion is positioned on the implant retainer in a location providing

access to the second suture hole on the implant unit proximate to a second end of the arc, and wherein the first suture guide portion is configured to direct the suture needle toward the second suture guide portion.

6. The device of claim 1, wherein the first suture guide portion includes an aperture.

7. The device of claim 1, wherein the arcuate channel is configured to receive a surgical needle selected from the group consisting of a ¼

circle, a ⅜

circle, a ⅝

circle, and a ½

circle needle.

8. The device of claim 1, including a locking mechanism configured to temporarily affix at least a portion of the implant retainer in a fixed location relative to tissue in the body of the subject.

9. The device of claim 1, including automatic sutures configured to be triggered to fix the implant unit in place relative to tissue in the subject'"'"'s body.

10. The device of claim 1, wherein:

the first protruding portion protrudes from at least a proximal side of the first face towards the second face, and

the second protruding portion protrudes from at least a proximal side of the second face towards the first face.

11. The device of claim 1, wherein:

the first jaw further includes a first release portion, the first release portion being located at a distalmost edge of the first face and being substantially flush with the first face, and

the second jaw further includes a second release portion, the second release portion being located at a distalmost edge of the second face and being substantially flush with the second face.

12. The device of claim 1, wherein the first protruding portion and the second protruding portion are configured to retain the implant such that the first suture guide portion aligns with a first suture hole in the implant and the second suture guide portion aligns with a second suture hole in the implant.

13. The device of claim 1, wherein

the first protruding portion is further configured to engage at least three sides of the first perimeter of the first extension, and

the second protruding portion is further configured to engage at least three sides of the second perimeter of the second extension.

14. A delivery system comprising:

an implant retainer configured to releaseably hold an implant unit configured for implantation adjacent a genioglossus muscle of a subject and maintain the implant unit in a fixation location relative to the genioglossus muscle tissue during an implantation procedure, the implant including a first extension of an elongate arm having a first perimeter and a second extension of an elongate arm having a second perimeter, the implant retainer including a pair of jaws;

a handle disposed on a proximal end of the pair of jaws; and

a locking mechanism configured to maintain the spacing of the jaws;

wherein the pair of jaws includes;

a first suture guide portion disposed on a first jaw, the first suture guide portion configured to guide a suture needle through a first suture hole in the retained implant during the implantation procedure, wherein the first jaw has a first face and a first protruding portion extending from the first face at a periphery of the first face, and the first protruding portion is configured to accept and surround at least a portion of the first perimeter of the first extension when the first extension lies against the first face, and

a second suture guide portion disposed on a second jaw, the second suture guide portion configured to receive and guide the suture needle through a second suture hole in the retained implant unit after the suture needle exits the first suture guide portion, wherein the second jaw has a second face and a second protruding portion extending from the second face at a periphery of the second face, and the second protruding portion is configured to accept and surround at least a portion of the second perimeter of the second extension when the second extension lies against the second face.

15. The delivery system of claim 14, wherein the locking mechanism includes a ratchet mechanism.

16. The delivery system of claim 14, wherein the pair of jaws includes a ratchet mechanism configured to maintain a spacing of the jaws.

17. The delivery system of claim 14, wherein the implant unit is configured to assume an arc shape relative to the pair of jaws, wherein the first suture guide portion is positioned on the pair of jaws in a location providing access to the first suture hole on the implant unit proximate to a first end of the arc, wherein the second suture guide portion is positioned on the pair of jaws in a location providing access to the second suture hole on the implant unit proximate to a second end of the arc, and wherein the first suture guide portion is configured to direct the suture needle toward the second suture guide portion.

18. The delivery system of claim 14, wherein the first suture guide portion includes an aperture.

19. The delivery system of claim 14, wherein the second suture guide portion includes an arcuate channel.

20. The delivery system of claim 19, wherein the arcuate channel is configured to receive a surgical needle selected from the group consisting of a ¼

circle, a ⅜

circle, a ⅝

circle, and a ½

circle needle.

21. The delivery system of claim 14, wherein the second suture guide portion includes an arcuate channel extending from a distal end of the second jaw toward the handle.

22. The delivery system of claim 14, including automatic sutures configured to be triggered to fix the implant unit in place relative to tissue in the subject'"'"'s body.