Suture passer systems and methods for palate suspension and compression

• US 9,386,981 B2
• Filed: 06/07/2013
• Issued: 07/12/2016
• Est. Priority Date: 03/31/2010
• Status: Active Grant

• Current Assignee: Siesta Medical, Inc.
• Original Assignee: Siesta Medical, Inc.
• Inventors: van der Burg, Erik, Martin, Peter, Feezor, Chris, Hirotsuka, Mark, Jackson, Jasper, Cheng, Christopher T., Kolber, Michael, Liston, Adam H.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/913,123
• Publication Number:
  US 20130345724A1
• Time in Patent Office: 1,131 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00814 Surgery of the tongue, e.g. glossoplasty
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Suture passer systems for tissue suspension and tissue compression, and more particularly for palate or tongue suspension, are described. The system can include at least a first elongate tubular body or shaft, a needle having a lateral bias carried by the elongate body, and a retrieval element operably connected to the elongate tubular body. The needle can have a substantially straight configuration when located within the elongate tubular body, and be configured to exit an opening at or near a distal end of the elongate tubular body and assume a laterally biased or curved shape to form a path through tissue. The needle is configured to carry a suture. The retrieval element can be configured to retrieve the suture carried by the needle after the needle has formed a curved or otherwise angled path through tissue. The system can also include one or more bone anchors to secure the suture loops. Methods of placing one or more suture loops into tissue, such as the base of the palate or tongue, are also described.

Claims

1. A method of treating a condition of an airway, comprising:

delivering an elongate shaft proximate the hyoid bone;

delivering a needle having a distal end configured to be laterally biased and carried within the elongate shaft further at least partially around the hyoid bone, the needle carrying a suture, the needle exiting an opening in the elongate shaft and forming a curved or lateral path not coaxial with a longitudinal axis of the elongate shaft to carry the suture along the path; and

grabbing the suture with a retrieval element at a location proximate the hyoid bone;

wherein the needle is retractable back into the elongate shaft;

wherein the retrieval element is operably connected to the elongate shaft.

2. The method of claim 1, wherein the elongate shaft comprises a first elongate shaft member and a second elongate shaft member, the first elongate shaft member releasably housing the needle and the second elongate shaft member comprising the retrieval element.

3. The method of claim 1, further comprising:

withdrawing the elongate shaft to place at least one suture loop surrounding the hyoid bone; and

suspending the hyoid bone by securing suture passed around the hyoid bone to a bone anchor.

4. The method of claim 3, wherein the suture passed around the hyoid bone is the suture placed by the elongate shaft.

5. The method of claim 3, wherein the suture passed around the hyoid bone is a tension element passed around the hyoid bone that follows the path of the suture loop placed by the elongate shaft, wherein the suture loop has a width that is less than the width of the tension element.

6. The method of claim 5, wherein the tension element is advanced around the hyoid bone by pulling the suture loop placed by the elongate shaft, the tension element attached to the suture loop.

7. The method of claim 3, wherein securing suture passed around the hyoid bone to the bone anchor is accomplished after grabbing the suture with a retrieval element at a location proximate the hyoid bone.

8. The method of claim 3, wherein securing suture passed around the hyoid bone to the bone anchor comprises threading a portion of suture through an eyelet of the bone anchor, and reducing a height dimension of the eyelet such that the portion of suture is retained within the eyelet.

9. The method of claim 8, wherein reducing the height dimension of the eyelet comprises reducing the height dimension of the eyelet to between about 0.005 inches and about 0.020 inches.

10. The method of claim 8, wherein the bone anchor comprises:

a proximal head portion having an eyelet having a sidewall with a distal surface defining a first cavity therein and configured for at least one suture to pass therethrough and a distal threaded portion for engaging a bone, wherein the proximal head portion comprises a locking screw having a proximal end and a distal end, the locking screw configured to fit within a second cavity that communicates with the first cavity, wherein rotation of the locking screw to move the locking screw in a distal direction allows the locking screw to enter the first cavity and decrease the height dimension sufficient to prevent movement of the suture within the eyelet, wherein the height dimension is defined by the distance between the distal surface of the cavity and the distal end of the locking screw, wherein the height dimension is greater than zero.

11. The method of claim 10, wherein the height dimension sufficient to prevent movement of suture within the eyelet is between about 0.005 inches and about 0.02 inches.

12. The method of claim 3, wherein the bone anchor comprises:

a proximal head portion having an eyelet defining a cavity therein and configured for at least one suture to pass therethrough, wherein the proximal head portion comprises a cam lock configured to rotate within the cavity, the cam lock comprising a shaft member radially offset from a longitudinal axis of the cam lock and connected between two cylindrical bearings, wherein the rotation of the cam lock is configured rotate the shaft member to reduce a space between an inner wall of the cavity and an outer surface of the shaft member, the rotation of the cam lock defining an open state and a closed state; and

a distal threaded portion for engaging tissue;

wherein the space in the closed state is dimensioned to effectively secure the suture between outer surface of the shaft member and the inner wall of the cavity.

13. The method of claim 12, wherein the proximal head portion comprises a plurality of faces forming a symmetrical polygonal shape, the eyelet radially offset from an axis of symmetry of the polygonal shape.

14. The method of claim 3, further comprising suspending the hyoid with a suture comprising a substantially flattened section.

15. The method of claim 14, wherein the suture used for suspending the hyoid comprises a radiopaque marker.

16. The method of claim 3, further comprising attaching the bone anchor to bone before grabbing the suture with a retrieval element at a location proximate the hyoid bone.

17. A method for treating a condition of an airway, comprising:

creating a first pathway proximate the hyoid bone;

creating a second pathway proximate the hyoid bone;

passing a flexible elongate member extending through the first pathway proximate the hyoid bone, from the first pathway to the second pathway; and

withdrawing the flexible elongate member through the second pathway, leaving the flexible elongate member to form a looped path around the hyoid bone, wherein the first pathway and second pathway are created with a suture passer having two elongate shafts connected to one another, and the flexible elongate member is a suture that is passed from one elongate shaft to the other with a needle that passes through tissue surrounding the hyoid bone.

18. The method of claim 17, further comprising:

advancing a tensioning structure through the looped path, wherein the structure is attached to the flexible elongate member and the flexible elongate member is removed from surrounding the hyoid bone; and

securing the tensioning structure to a body structure to apply force to the hyoid bone.

19. The method of claim 18, wherein the body structure is a bone.

20. The method of claim 18, wherein the flexible elongate member is a guide suture having a width that is less than the width of the structure.