Patent Application
20120123447
The present invention relates to a device for imparting tension to a suture. More particularly, the invention relates to an integrated suture tensioning device that creates and maintains suture connection during surgical applications.
It is a common requirement to use devices for tensioning flexible material during surgery to secure tissue, such as a tendon, ligament, or bone under tension to a neighboring tissue (e.g., another bone or bone surface). Suture or other flexible material (i.e., cable, fiber tape, or any other suitable flexible material) can be used to secure tissue (e.g. ligament, tendon, bone) to a nearby bone or other medical device such as a bone plate or expanded washer resting on the surface of a nearby bone. This flexible material will often be tensioned between the neighboring tissue (at one end) and a bone or medical device at the other end. This tension has been accomplished either manually or by a number of devices, such as an adjustment wheel device that has sutures secured to them and are rotated to provide tension to the suture.
Manual tensioning of sutures often results in imprecise tension or a loss of tension during a surgical procedure, for example, as a permanent fixation member is applied. In addition, often such devices require the user to use both of their hands during the tensioning step in a procedure. The use of both hands during a procedure may require an additional person to be present. Further, in some instances it may be difficult to have more than one set of hands involved during a surgical procedure having limited space. This is particularly true when the device needs to create and maintain tension on a suture or flexible material throughout the procedure.
Therefore, there remains a need for a convenient and effective device for creating and then maintaining tension on a suture or flexible material, ideally with one hand. The device would preferably be operable by one individual to securely create and maintain tension on a suture or flexible material while the permanent fixation member is applied.
In one embodiment, a device tensioning flexible material (e.g., a suture) of the invention will typically comprise a housing that defines a channel and a shaft slidably disposed in the channel. In one embodiment, the housing may comprise an upper portion, a lower portion, a proximal end and a distal end. The channel may be defined by any portion of the housing, for example, the upper portion of the housing may have a channel extending axially therethrough. A device of the invention may comprise a handle, for example, the lower portion of the housing may comprise a handle. The shaft comprises a proximal end and a distal end and is slidably supported in the housing channel. In some embodiments, the shaft may comprise a plurality of notches that may be disposed along all or a portion of one or more surfaces of the shaft. In some embodiments, the shaft may comprise an engagement member at the proximal end of the shaft.
A device of the invention may comprise a tension anchor. In use, a flexible material to be tensioned may be attached to the tension anchor such that the suture remains fixed with respect to the housing. The tension anchor may be located on any portion of the housing, for example, on a surface of the upper housing. In some embodiments, a tension anchor may comprise a tension carriage member which may slidably engage the upper portion of the housing.
A device of the invention will typically comprise a trigger member comprising an upper portion and a lower portion. In some embodiments, the upper portion includes a drive ratchet comprising a ratchet pawl pivotally mounted thereto. Typically, a spring may be compressibly disposed between the trigger member and the handle for biasing the trigger member and the handle apart. In use, depression of the trigger member causes the ratchet pawl to engage a notch on the shaft and urges the housing toward the distal end of the shaft.
In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device including positioning the tensioning device such that an engagement member of the device is adjacent to a subject having a suture extending therefrom, attaching the suture to tension anchor and depressing the trigger member to provide tension on the suture. Such methods will typically include maintaining tension on the suture until the suture can be fixed with a tension securing means. Examples of tension securing means include, but are not limited to, a threaded sleeve and screw (e.g., a set screw) construct adapted to engage the suture in a compression fit, a button, or other fixation device known to those skilled in the art.
In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device in combination with a bone plate, threaded sleeve and a tension securing means. Such methods will typically include positioning the tensioning device such that an engagement member of the device is adjacent to the threaded sleeve through which a suture extends, attaching the suture to the tension anchor and depressing the trigger member to provide tension on the suture. Such methods may also comprise maintaining tension on the suture until the suture can be fixed with a tension securing means and securing the suture with a tension securing means.
In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device in combination with a washer and a threaded sleeve. Such methods will typically include positioning the tensioning device such that an engagement member of the device is adjacent to the washer and threaded sleeve through which a suture extends, attaching the suture to the tension anchor and depressing the trigger member to provide tension on the suture. Such methods may also comprise maintaining tension on the suture until the suture can be fixed with a tension securing means and securing the suture with a tension securing means.
Other features and advantages of the invention will become apparent to those skilled in the art from the following description of the invention, which refers to the accompanying drawings.
A device of the invention will include a shaft. The shaft may have any cross-section, for example, may have a square cross-section and is disposed in the housing. Other contemplated cross-sections include, but are not limited to, circular, oval, and polygonal (e.g., hexagonal). As shown in the figures, a generally rectangular shaft 20 includes a proximal end 24, a distal end 22 and engagement member 21. The shaft 20 includes a plurality of notches 23 which extend along at least a portion of at least one side of the shaft 20. The engagement member 21 includes engagement fingers 25 and lip 26. The notches 23 may be angled toward the distal end 22 of the shaft 20. The shaft 20 may be rotated prior to use to provide an alternative position of the engagement member 21. The housing 11 is slidably supported on the shaft 20 from the shaft's proximal end 24 to the shaft's distal end 22. The housing 11 is biased in the distal direction of the shaft 20 by a trigger member 30 pivotally connected to the housing 11.
The present invention further contemplates a cannulated shaft. A cannulated shaft may define a bore extending axially therethrough. In some embodiments, the bore of a cannulated shaft may extend from the distal end of the shaft to the proximal end of the shaft. In other embodiments, the bore of the cannualted shaft may extend through a portion of the length of the shaft, for example, from the proximal end or near the proximal end of the shaft to approximately one eight, one fourth, one half or three quarters of the length of the shaft measured from the proximal end. A flexible material (e.g., a suture) may be disposed in the bore of a cannulated shaft.
As shown in
During operation of the device 10 when the trigger member 30 is depressed the trigger member 30 causes the drive ratchet 31 to engage a notch 23 of shaft 20 with hook member 35 and urges the housing 11 toward the distal end 22 of the shaft 20. In this state, the ratchet pawl 50 is lowered to a point where the protrusion 52 is disengaged from contacting the shaft's notches 23 which permits movement of the housing 11 away from the proximal end of the shaft 20. During operation, a suture (not shown) is secured to a tension anchor, for example, to a post member 61 or 62 of tension carriage member 60 and a pulling force is applied to the suture, thereby providing and maintaining tension to the suture.
Referring now to
A method of tensioning a suture technique employed in a clavicle fracture repair, for example, is now described with reference to
According to a preferred method of tensioning a suture of the present invention, a length of flexible material 1401 is employed in connection with the bone plate 901 and is placed through an opening 903 of the bone plate 901 through a pre-drilled hole along the fracture 1201 and secured through, around another bone or with an anchor in the bone, for example, a coracoid process 1102. The engagement member 21 of the shaft 20 is positioned in the bone plate opening 903 and a length of flexible material 1401 is secured around tension carriage's post 61 or 62.
For the purposes of illustration and without limitation, the term “suture” or “flexible material” as used herein may be a cable, filament, thread, wire, fiber tape or any other flexible member suitable for bone fixation in the body.
After securing the flexible material 1401 around the through the post 61 or 62 of the tension carriage 60, the user grasps the trigger 30 with one hand, for example the right hand, and compressing the trigger 30 inward to exert tension on the flexible material 1401. Housing 11 slides upward and away from the bone plate 901. As the housing 11 increases its distance from the bone plate 901, tension in the flexible material is increased. Once the desired amount of tension is achieved a securing means can be placed in the opening 903 to maintain the tension between the coracoid process 1102 and the clavicle 1101. In this manner, the flexible material 1401 is precisely tensioned and positioned at an appropriate distance from the bone sections 1102 and 1101. One preferred example of a securing means is a knotless fixation device as shown in published United States patent application US 20100262185 which is specifically incorporated herein by reference in its entirety.
Referring now to
Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred, therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.
