The present disclosure relates to surgical devices and, more particularly, to a tether tensioning device.
When an individual's spine presents abnormal curvature, the vertebrae are inclined relative to one another and relative to said vertebral axis. The lateral edges of the vertebrae situated on one side are thus closer to one another and form a concave curve, while the lateral edges on the other side appear spaced apart from one another and form a convex curve. In order to straighten the spinal column, the lateral edges of the vertebrae on the concave side are spaced apart from one another and are taken relative to one another to a distance that is substantially equivalent to the distance between the lateral edges on the other side. Thereafter, in order to keep the vertebrae in that position relative to one another, known devices such as spinal rods are utilized.
In rod-based techniques, one or more spinal rods are attached to the vertebrae at several fixation sites to progressively correct the spinal deformity. The spinal rods are typically pre-curved intraoperatively to a desired adjusted spinal curvature. Wires as well as bone screws can be used to pull individual vertebra toward the spinal rod. The rigidity and permanence of rigid rod-based systems can also hinder or prevent growth of the spine and they generally require fusion of many spine levels, drastically reducing the flexibility of the spine. To help remedy some of these issues, a tether and anchor system can be used to correct curvature of the spine using a number of anchors disposed within the spinal bones that are connected with tethers extending between them. The elasticity of the tethers prevents some of the problems with the rigidity and permanence of the rod-based systems, although the tethers must be tensioned after implantation to achieve the desired force between the anchor to correct the spinal deformities.
Therefore, a continuing need exists for a tether tensioner that can provide adequate tensioning of the tethers to provide spinal correction, while maintaining the safety of the patient.
In accordance with an embodiment of the present disclosure, a tether tensioner includes a handle assembly, an elongate member extending distally from the handle assembly, and an engaging portion. The handle assembly includes a stationary member, a trigger pivotably coupled to the stationary member, and a spool rotatably supported on the stationary member. The spool is configured to wrap a tether thereabout. The spool is operatively coupled with the trigger such that pivoting of the trigger relative to the stationary member causes rotation of the spool. The elongate member includes a channel configured to slidably receive a tether therethrough. The engaging portion is configured to receive a head portion of a bone screw such that a tether extends from the head portion disposed in the engaging portion to the spool through the channel of the elongate member. In an embodiment, the handle assembly may further include a ratchet wheel operatively coupled with the spool for concomitant rotation therewith. In another embodiment, the trigger may include a rack including teeth to engage teeth of the ratchet wheel. In yet another embodiment, the handle assembly may further include a biasing member to urge the rack towards engagement with the ratchet wheel. In an embodiment, the handle assembly may further include a biasing member to urge the trigger away from the stationary member. In still yet another embodiment, the spool of the handle assembly and the channel of the elongate member may be axially aligned. In an embodiment, the engaging portion may be disposed at a distal portion of the elongate member. In another embodiment, the elongate member may be substantially parallel to the stationary member of the handle assembly. In yet another embodiment, the engaging portion may include a chamber defining an aperture to receive a head portion of a bone screw therethrough. In still yet another embodiment, the elongate member may define a bore dimensioned to receive a tether therethrough. The bore may be in communication with the aperture of the chamber of the engaging portion. In an embodiment, the engaging portion may be positioned with the tether receiving channel of the tensioner aligned with the tether receiving slot of the head of the bone screw. In an embodiment, the chamber may include an inner wall having threads to threadably secure a set screw of a bone screw thereto. In another embodiment, the elongate member may define a groove along a length thereof. The groove may be configured to receive a driver to drive a set screw of a bone screw. In an embodiment, the groove of the elongate member may be aligned with the engagement portion.
In accordance with another embodiment of the present disclosure, a surgical kit includes a tether, a bone anchor including a bone screw and a set screw, and a tether tensioner. The bone screw has a head portion defining a slot dimensioned to receive the tether, and a shank having bone threads and extending from the head portion. The set screw has an anvil portion extending distally from the threaded portion. The anvil portion has a non-planar surface. The tether tensioner includes a handle assembly, an elongate member extending distally form the handle assembly, and an engaging portion. The handle assembly includes a stationary member, a trigger pivotably coupled to the stationary member, and a spool rotatably supported on the stationary member for wrapping the tether thereabout. The spool is operatively coupled with the trigger such that pivoting of the trigger relative to the stationary member causes rotation of the spool. The elongate member includes a channel configured to slidably receive the tether therethrough. The engaging portion is configured to receive the head portion of the bone screw such that the tether extends from the head portion disposed in the engaging portion to the spool through the channel of the elongate member. In an embodiment, the bone screw head portion of the tether tensioner may include an inner wall having threads, and the set screw may include threads. The threads of the bone screw head may be engageable with the threaded portion of the set screw. In another embodiment, the anvil portion of the set screw may include an engaging surface having a convex portion interposed between lateral concave portions. In yet another embodiment, the head portion of the bone screw may have an engaging surface having a concave portion interposed between lateral convex portions. In still another embodiment, the kit may further include a driver configured to drive the set screw. In an embodiment, the elongate member of the tether tensioner may include a groove along a length of the elongate member. The groove may be dimensioned to slidably receive the driver. In another embodiment, the handle assembly of the ratchet tensioner may further include a ratchet wheel operatively coupled with the spool for concomitant rotation therewith. The ratchet wheel may be configured to rotate in a single direction. In another embodiment, the engaging portion of the tether tensioner may include a chamber defining an aperture configured to receive the head portion of the bone screw therethrough. In yet another embodiment, the elongate member of the tether tensioner may define a bore dimensioned to receive the tether therethrough. The bore may be in communication with the aperture of the chamber of the engaging portion.
In accordance with another aspect of the present disclosure, a method of applying tension to a tether includes securing a first end portion of a tether relative to a bone screw; passing a second end portion of the tether through a first slot in a bone screw and through a second slot defined in a distal end of an engaging portion of a tether tensioner; extending the second end portion of the tether through a bore defined in an elongate member of the tether tensioner towards a handle assembly of the tether tensioner; wrapping the second end portion of the tether around a spool of the handle assembly; placing the engaging portion of the tether tensioner over a head portion of the bone screw such that the tether extends through the slot defined in the head portion of the bone screw and into the second slot of the engaging portion; rotating the spool to provide tension in the tether; and securing the tether to the bone screw. In an embodiment, the method may further include manipulating the tether to provide proper tension prior to rotating the spool. In another embodiment, the method may further include partially securing the tether to the second bone screw prior to rotating the spool. In yet another embodiment, securing the first end portion relative to bone may further include securing the first end of the tether to a first bone screw, and looping the tether around an anatomical structure before passing the second end portion of the tether through the tether receiving slots of the bone screw and the engaging portion. In yet another embodiment, the method may further include feeding the second end of the tether through a channel of the elongate member and towards the handle assembly of the tether tensioner. In still yet another embodiment, securing the tether to the second bone screw may include threadably coupling a set screw disposed in the engaging portion to the head portion of the second bone screw to secure the tether therebetween. In yet another embodiment, the set screw may include a first non-planar surface and the first slot of the bone screw includes a second non-planar surface, the method may further comprise tightening the set screw to apply a pressure between the first and second non-planar surfaces to lock the tether disposed therebetween and extending through the first slot.
In accordance with another aspect of the present disclosure, a bone anchor defining a longitudinal axis comprising a head portion having a first opening concentric about the longitudinal axis, a second opening transverse to the longitudinal axis and in communication with the first opening, and a first non-planar surface at a distal end of the first opening, and a set screw receivable in the first opening and having a second non-planar surface at a distal end thereof, the second non-planar surface corresponding to the first non-planar surface, the second opening in communication with the first opening such that a tether passed through the second opening traverses the first opening across the non-planar surface, wherein tightening the set screw applies a pressure between the first and second non-planar surfaces to lock the tether disposed therebetween and extending through the first slot. In other aspects, the bone anchor may further comprise a shank having threads and extending from the head portion. In other aspects, the first opening may include threads and the set screw is threadably receivable in the first opening. In other aspects, a bone anchor system may include the above bone anchor and a tether engaged between the first and second non-planar surfaces.
Various aspects of the present disclosure are described hereinbelow with reference to the drawings, wherein:
The presently disclosed tether tensioner will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
As shown in the drawings and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the terms “proximal” and “trailing” may be employed interchangeably, and should be understood as referring to the portion of a structure that is closer to a clinician during proper use. The terms “distal” and “leading” may also be employed interchangeably, and should be understood as referring to the portion of a structure that is farther from the clinician during proper use. In addition, the term “cephalad” is used in this application to indicate a direction toward a patient's head, whereas the term “caudad” indicates a direction toward the patient's feet. Further still, the term “medial” indicates a direction toward the middle of the body of the patient, whilst the term “lateral” indicates a direction toward a side of the body of the patient (i.e., away from the middle of the body of the patient). The term “posterior” indicates a direction toward the patient's back, and the term “anterior” indicates a direction toward the patient's front.
With reference to
With continued reference to
With particular reference to
With reference now to
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With continued reference to
The handle assembly 200 is dimensioned to fit in a palm of a clinician such that fingers of the clinician wrap around the trigger 206. Under such a configuration, the clinician may squeeze the trigger 206 with the fingers to apply tension to the tether 600 (
With reference now to
With particular reference to
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With reference now to
It is envisioned that the tether 600 may be made from various polymers including, e.g., nylon, Dacron®, Ultra-High-Molecular-Weight Polyethylene (UHMWPE), polypropylene, and polyester. It is also contemplated that the tether 600 may include a body, a leader, and a guide wire. The body may include a stiffening wire to increase the stiffness of the body. The stiffening wire may be embedded in the body or may be externally bonded (i.e., bonded on an external surface of the body). The stiffening wire may be bonded along the entire length of the body or only a portion of the length of the body. Reference may be made to U.S. Patent Application Publication No. 2014/0257397, and International Patent Application Publication No. WO 2016/172677, the entire contents of each of which are incorporated herein by reference, for a detailed discussion of the construction and operation of the fastening system.
With reference to
Thus, the tether 600 passes through the mounting portion of the elongate member 300 and through the receiving slot of the second screw, ready to be tensioned. The head portion 530 of the second screw 520 is received in the chamber 402 of the engaging portion 400 such that the tether 600 extends through the slot 532 (
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
The present application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62/932,894 filed Nov. 8, 2019, the disclosure of which is hereby incorporated herein by reference.
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