Patent Description:
The present invention is related to anchors for securing material to soft tissue and bone and, more particularly, to suture anchors and suture anchor deployment devices for knotlessly securing filamentary materials, and soft tissue at a surgical/repair site.

Suture anchors are commonly employed during surgical procedures to secure soft tissue to bone. Such anchors are generally inserted into a pre-formed hole in the bone ("pilot hole"), so that a portion of filamentary material (e.g., suture material/sutures) extends out of the hole from the anchor and then the suture materials are passed through the tissue to be repaired. Once the tissue has been approximated to bone, the surgeon can tie one or more knots to secure the sutures. The act of tying a knot presents a number of challenges to the surgeon especially when doing them arthroscopically. See <CIT>, col. <NUM>, lines <NUM>-<NUM>. Furthermore, in some cases, knots have been implicated as the source of postoperative pain caused by irritation from the knot stack.

Various types of suture anchors have been developed which fasten the suture in place without requiring the surgeon to tie a knot. Typically, with respect to these conventional suture anchors, the suture is captured between two opposing surfaces and held in place by friction. Some designs capture the suture between two anchor components while others utilize an interference fit between the anchor and the bone tunnel. Provided the bone quality is sufficient, the latter method provides simplicity.

Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section and/or throughout the application. <CIT> discloses a cannulated implant deployment device, comprising an elongated and cannulated driver shaft extending along a longitudinal axis comprising a proximal end and a distal end; a cannulated implant removably attached to the distal end of the driver shaft; a handle assembly connected to the proximal end of the driver shaft comprising a proximal handle and a knob positioned distally to the proximal handle and a driver shaft advancement member positioned distally to the knob. The proximal handle serves as suture capture advancement member and does not serve for rotating the driver shaft. The suture is clamped at the distal end of the anchor assembly and is guided outside of the driver shaft to be tensioned and clamped on a cleat positioned at the knob. - <CIT> discloses a cannulated implant deployment device, comprising an elongated and cannulated driver shaft extending along a longitudinal axis comprising a proximal end and a distal end; a cannulated implant removably attached to the distal end of the driver shaft; a handle assembly connected to the proximal end of the driver shaft comprising a proximal handle and a knob positioned distally to the proximal handle. The proximal handle serves for rotating the driver shaft. A cleat is positioned at the proximal handle and serves for clamping a proximal end of a suture which is guided within the interior of the driving shaft and exits through an aperture to be tensioned and clamped on the cleat.

Embodiments of the present invention recognize that there are potential problems and/or disadvantages with the conventional suture anchors and their deployment devices. For example, adjusting and maintaining the proper suture tension can be difficult and remains a lingering problem. Therefore, the need exists for a simple to use suture anchor which secures suture without the need to tie a knot and which facilitates the ability to adjust and maintain suture tension during anchor installation. Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and/or disadvantages discussed herein.

The subject of the present invention is defined by a cannulated implant deployment device according to claim <NUM>.

According to an embodiment, the axial rotation of the proximal handle in the first direction results in the axial rotation of the implant in the first direction and the maintenance of about <NUM>% of the first applied tension value when the implant is rotated in the first direction and advanced in the distal direction within the pilot hole.

According to an embodiment, the cleat is connected to the driver shaft such that it is configured to move the same distance in the distal direction as the implant is advanced in the distal direction.

According to an embodiment, the implant contains external threading extending along at least a portion of an outside surface of the implant.

According to an embodiment, the driver shaft contains external threading extending along at least a portion of an outside surface of the driver shaft and the knob contains internal threading extending along at least a portion of an inside surface of the knob, wherein the external threading of the driver shaft mates with the internal threading of the knob forming a threaded interface, and the external threading of the driver shaft is configured to move in the distal direction in response to the axial rotation of the proximal handle in the first direction.

According to an embodiment, the pitch of the external threading of the implant is about the same as the pitch of the external threading of the driver shaft.

According to an embodiment, the knob is not fixed to and is configured to rotate around the driver shaft.

According to an embodiment, the cannulated implant deployment device further comprises a suture threader positioned through the driver shaft from an aperture formed in the side of the driver shaft between the proximal end of the driver shaft and the distal end of the driver shaft through an opening in the distal end of the implant, wherein the suture threader comprises a suture catch positioned distally to the distal end of the implant sufficient to capture a portion of a suture.

According to an embodiment, the suture catch is formed as an eyelet.

According to an embodiment, the handle further comprises a locking mechanism configured to allow axial rotation of the handle in the first direction only.

According to an another aspect, a method of deploying a cannulated implant into a pilot hole formed in a segment of bone tissue includes (but is not limited to) the steps of: providing a cannulated implant deployment device including: an elongated and cannulated driver shaft extending along a longitudinal axis comprising a proximal end and a distal end; a cannulated implant removably attached to the distal end of the driver shaft; a handle assembly connected to the proximal end of the driver shaft comprising a proximal handle and a knob positioned distally to the proximal handle; and a cleat positioned on the driver shaft distally to the knob; securing a proximal end of a suture extending from a distal end of the implant to the cleat; inserting the implant into the pilot hole to secure a first distal portion of the suture within the pilot hole, and forming a first applied tension value of the suture extending between the proximal portion of the suture and the first distal portion of the suture; and rotating the proximal handle in a first direction to effectuate rotation of the implant in the first direction and the maintenance of at least <NUM>% of the first applied tension value when the implant is rotated in the first direction and advanced in the distal direction within the pilot hole.

According to an aspect, the step of rotating the proximal handle in the first direction results in the rotation of the implant in the first direction and the maintenance of about <NUM>% of the first applied tension value when the implant is rotated in the first direction and advanced in the distal direction within the pilot hole.

According to an aspect, the step of rotating the proximal handle in the first direction results in the tensioning of a second distal portion of the suture attached to a segment of soft tissue and appositioning the segment of the soft tissue to the segment of bone tissue.

According to an aspect, the step of rotating results in the movement of the cleat in the distal direction away from the knob.

According to an aspect, the step of rotating results in the movement of the cleat the same distance in the distal direction as the implant is advanced in the distal direction.

According to an aspect, the method further includes the step of providing the deployment device with a suture threader positioned through the driver shaft from an aperture formed in the side of the driver shaft between the proximal end of the driver shaft and the distal end of the driver shaft through an opening in the distal end of the implant, wherein the suture threader comprises a suture catch positioned distally to the distal end of the implant.

According to an aspect, the method further includes the steps of capturing the suture with the suture catch; and pulling the suture through the driver from the distal end of the implant through the aperture positioned between the proximal end of the driver shaft and the distal end of the driver shaft to the cleat on which it is secured prior to the step of securing.

According to a further embodiment, a cannulated knotless anchor implant for use with a cannulated implant deployment device according to claim <NUM> is provided, and includes: an elongated body extending along a longitudinal axis between a proximal end and a distal end; and a plurality of screw threads positioned about at least a portion of an exterior surface of the elongated body; where a density of the plurality of screw threads varies along the exterior surface.

Suture material or sutures, as the terms are used and described herein, include monofilament or multi-filament suture as well as any other metallic or non-metallic filamentary or wire-like material suitable for performing the function of a suture. This material can include both bioabsorbable and non-absorbable materials.

Knotless suture anchors/implants, as the terms are used and described herein, may be formed of a biocompatible and/or bioabsorbable material. These materials may be of such composition that they are reabsorbed by the body, e.g., during the healing process of the bone. Exemplary materials that are suitable for use in the inner and outer members include, but are not limited to, polyetheretherketone ("PEEK"), polylactic acid/beta-tricalcium phosphate ("PLA/Beta-TCP") composites, ultra-high molecular weight polyethylene ("UHMWPE"), as well as other metallic, non-metallic, and polymeric materials.

The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:.

Referring now to the drawings, wherein like reference numerals refer to like parts throughout, there is seen in <FIG> a knotless anchor deployment device <NUM> including an elongated and cannulated driver shaft <NUM> extending along a longitudinal axis comprising a proximal end <NUM> (positioned within handle <NUM>; shown in <FIG>) and a distal end <NUM> (positioned within a cannulated knotless anchor implant <NUM>). The cannulated knotless anchor implant <NUM> is removably attached to the distal end <NUM> of the driver shaft <NUM>, and preferably contains external threading (but is not required to include the external threading). A handle assembly is connected to the proximal end <NUM> of the driver shaft <NUM>, which includes a proximal handle <NUM> and a knob <NUM> positioned distally to the proximal handle <NUM>. A cleat <NUM> is positioned on the driver shaft <NUM> distally to the knob <NUM>. The cleat is formed of a central cylindrical portion <NUM>-<NUM> surrounding the driver shaft <NUM> and two cleated winged portions <NUM>-<NUM> (see <FIG>). A suture threader <NUM> can be positioned through an aperture <NUM> (which can be a hole or a channel) formed in a side of the driver shaft <NUM> between the proximal end of the driver shaft and the distal end of the driver shaft, and can extend through an opening <NUM> in the distal end of the implant <NUM>. The threader <NUM> can include a finger grip <NUM> attached to the proximal end of the threader <NUM> and a suture catch <NUM> attached to the distal end of the threader, which can be positioned distally to the distal end of the implant <NUM> sufficient to capture a portion of a suture <NUM>. The suture catch <NUM> as shown is shaped like an eyelet. However, any shape or structural configuration that is sufficient to capture a portion of a suture <NUM> is contemplated.

Turning to <FIG>, a side view schematic representation of the middle to the proximal end of a knotless anchor deployment device shown in <FIG> according to an embodiment is provided. The handle <NUM>, knob <NUM> and cleat <NUM> are shown. Referring to <FIG>, a perspective view schematic representation of section B-B of the knotless anchor deployment device shown in <FIG> according to an embodiment is provided. <FIG> shows a magnified perspective view schematic representation of section "D" of the knotless anchor deployment device shown in <FIG> according to an embodiment. Threads <NUM> are shown on a portion of the outer surface of the driver shaft <NUM>, and threads <NUM> are shown on the inside of the knob <NUM> forming a threaded interface <NUM> with threads <NUM>. A portion of the cleat <NUM> opposite the threaded interface includes a tooth <NUM> that engages a slot <NUM> formed in driver shaft <NUM>, which connects the driver shaft <NUM> to the cleat <NUM>. Referring to <FIG>, a magnified perspective view schematic representation of section "C" of the knotless anchor deployment device shown in <FIG> according to an embodiment is provided. A shaft <NUM>/handle <NUM> interface <NUM>, similar to the tooth <NUM> that engages a slot <NUM> formed in driver shaft <NUM>, is shown which connects the driver shaft <NUM> to the handle <NUM>. The tooth <NUM>/slot <NUM> connection between the cleat <NUM> and the driver shaft <NUM> is configured and/or structured to allow the cleat <NUM> to axially rotate with the driver shaft <NUM>. This axial movement can occur upon the axial rotation of the handle <NUM>, which is configured and/or structured to axially rotate the driver shaft <NUM> based on the shaft <NUM>/handle <NUM> interface <NUM> connection.

In accordance with an exemplary embodiment, a method <NUM> of deploying the cannulated knotless anchor implant <NUM> with the knotless anchor deployment device <NUM> into a pilot hole <NUM> formed in a section of bone <NUM> is set forth in <FIG>. The steps of the method set forth in <FIG> are discussed herein with reference to other Figures of this disclosure. In step <NUM>, the free ends of a portion/length of a suture <NUM>, which is passed through and attached on one end to a segment of soft tissue <NUM> (see <FIG>), is passed through the suture catch <NUM>. <FIG> also shows a segment of bone <NUM> with a pilot hole <NUM> formed therein.

In step <NUM>, the finger grip <NUM> of the suture threader <NUM> is pulled in the proximal direction, and the captured suture is pulled through the cannulated driver shaft <NUM> from the opening <NUM> in the distal end of the implant through the aperture <NUM> formed in the side of the driver shaft.

In step <NUM>, the cannulated knotless anchor implant <NUM> is advanced to the repair site (pilot hole <NUM>), while suture <NUM> slack is continued to be pulled through the driver shaft <NUM> from the opening <NUM> in the distal end of the implant through the aperture <NUM> formed in the side of the driver shaft to bring the segment of soft tissue <NUM> in close proximity to the distal tip of the cannulated knotless anchor implant <NUM> and to the pilot hole <NUM> (see <FIG>).

In step <NUM>, a proximal end of the suture <NUM> is secured to the cleat <NUM> by wrapping, for example, to either winged cleated portion of the cleat (see <FIG>), and the distal tip of the cannulated knotless anchor implant <NUM> is subsequently inserted into the pilot hole <NUM> pinning a distal portion of the suture between the implant <NUM> and the pilot hole <NUM>. This step can result in a first applied tension value of the suture extending between the proximal portion of the suture (attached to the cleat <NUM>) and the distal portion of the suture (within the pilot hole <NUM>), when the implant is placed in the pilot hole <NUM> to secure the distal portion of the suture within the pilot hole <NUM>. Rotation of the handle <NUM> can assist with the creation of the first applied tension value (which is a tension that is greater than an initial tension value, which can be generally loose suture which contains some "slack", as should be appreciated by a person of skill in the art in conjunction with a review of this disclosure), and to bring the segment of soft tissue <NUM> to apposition with bone. Alternatively, rotation of the knob <NUM> in one direction (e.g. counterclockwise) can extend the cleat <NUM> axially and distally away from the knob <NUM>, and rotation of the knob in a second direction (e.g., clockwise) can bring the cleat <NUM> closer (move axially and proximally) to the knob <NUM>, thereby reducing or adding to the tension value respectively. This axial movement of the cleat (and the driver shaft <NUM> attached to the cleat <NUM>) can assist in fine tuning the creation and maintenance of the applied tension value without the corresponding rotation of the cleat <NUM> and driver shaft <NUM> (due to the knob's configuration with respect to the driver shaft, as it is preferably not fixed to the driver shaft <NUM> in the same manner as the cleat <NUM> and the handle <NUM>).

In step <NUM>, the handle <NUM> is axially rotated in a first direction (e.g., clockwise; see <FIG>), and the deployment device <NUM> is advanced in the distal direction. The rotation of the handle <NUM> in the first direction results in the axial rotation of the shaft <NUM> and the cleat <NUM> in the first direction (due to the configuration etc. discussed above). This rotation also results in the axial rotation of the implant <NUM> in the pilot hole <NUM> (based on its connection to the distal end of the driver shaft <NUM>), and assists with the advancement of the implant <NUM> in the distal direction into the pilot hole <NUM>. The knob <NUM> is preferably held in place when the handle <NUM> is axially rotated, and is preferably not connected, configured, and/or structured to positively rotate in the first direction in the same way as the driver shaft <NUM> and the cleat <NUM> (i.e., it is not fixed to the driver shaft <NUM>). If the knob <NUM> is not held in place, the knob <NUM> may axially rotate a small amount in the first direction based on a frictional engagement with other parts of the deployment device <NUM>, but not at the same rate etc. as the handle <NUM>, driver shaft <NUM>, and cleat <NUM>.

Per the axial rotation of the handle <NUM> in the first direction, at least <NUM>% (and up to about <NUM>%) of the first applied tension value is maintained when the implant <NUM> is rotated in the first direction and advanced in the distal direction within the pilot hole (as long each end of the suture remains secured - to the cleat and within the pilot hole, respectively). In accordance with an embodiment, a percentage of the first applied tension value is maintained based on the cleat being configured to move in the distal direction away from the knob <NUM> upon the axial rotation of the handle <NUM> in the first direction. Upon the axial rotation in the first direction, the cleat <NUM> is connected to the driver shaft <NUM> such that it is configured to move the same distance in the distal direction away from the knob <NUM> as the implant <NUM> is advanced in the distal direction within the pilot hole <NUM>. This distal direction movement can be accomplished via the configuration of the external threading <NUM> on the driver shaft <NUM> (as described above), which forms a threaded interface <NUM> with the internal threading of the knob <NUM> and is configured to move in the distal direction in response to the axial rotation of the handle <NUM> in the first direction. Preferably, the pitch of the external threading of the implant <NUM> is about the same or exactly the same as (corresponds to) the pitch of the external threading <NUM> of the driver shaft <NUM>. The cleat <NUM> and the implant <NUM> each axially rotates in the first direction and translates distally at a rate corresponding to the pitch when the handle <NUM> is rotated to advance the implant <NUM> into the pilot hole <NUM>.

Notably, if the suture <NUM> were held stationary and not allowed into the pilot hole <NUM>, the implant <NUM> could be damaged, over tension the segment of soft tissue <NUM> leading to tissue incarceration or cause it to auger out the pilot hole <NUM>. If the suture <NUM> was not held (or if there was otherwise no or low tension maintained in the suture, as described) there would be a possibility of losing tension and tissue apposition to bone resulting in a bad repair.

In step <NUM>, the implant <NUM> is advanced until its proximal end is flush with the bone <NUM> surface (see <FIG>).

In step <NUM>, the suture can be removed from the cleat <NUM>, the implant <NUM> can be deployed, and the driver shaft <NUM> can be removed from the repair site (see <FIG>). The driver shaft <NUM> is pulled free from the implant <NUM> positioned within the pilot hole <NUM>, leaving the implant <NUM> within the pilot hole <NUM>. As shown in <FIG>, the implant <NUM> is attached to the distal end <NUM> of the driver shaft <NUM> via a friction fit. The lumen <NUM>-<NUM> of the driver shaft <NUM> within the lumen of the implant <NUM> is shown, and the lumen <NUM>-<NUM> of the implant without containing a portion of the driver shaft is also shown. The distal tip of the driver shaft <NUM> contains a cylindrical portion which is sized to create a slight interference with the cannulation of the implant <NUM>. For example, a stepped interface <NUM> between the lumen of the distal portion of the distal end of the driver shaft <NUM> and the lumen of the implant <NUM> is provided. This stepped interface <NUM> or additional stepped interfaces can exist in different positions between the lumen of the driver shaft <NUM> and the implant <NUM>. Another purpose of the stepped interface is to help prevent the driver shaft <NUM> from extending distally beyond the implant <NUM> during deployment. The force of the friction fit is preferably less than the force of the fit between the implant <NUM> and the pilot hole <NUM>, allowing the deployment device to be easily removed from the implant <NUM> and the pilot hole <NUM> after the implant <NUM> is deployed within the pilot hole <NUM>. The excess suture can be trimmed flush with the bone surface completing the repair.

In some embodiments (see <FIG>), the handle <NUM> can further include a ratcheting or locking mechanism including a round gear <NUM> with teeth and a biased, spring loaded/cantilevered finger <NUM> configured to allow axial rotation of the handle <NUM> (and thus, the driver shaft <NUM>, the cleat <NUM>, and the implant <NUM>) in the first direction only. As a user rotates the handle in the first (clockwise) direction, the distal end of the finger <NUM> moves from fitting between one set of teeth to a second set of teeth on the round gear <NUM> - where the round gear <NUM> is locked from moving in the opposite (counterclockwise) direction. This configuration preferably ensures that the tension is maintained during manipulation and placement of the implant <NUM> into the pilot hole <NUM>. The ratcheting or locking mechanism can include any type of mechanism which does not allow axial rotation in one direction, as should be appreciated by one of skill in the art in conjunction with a review of this disclosure.

Turning to <FIG>, a perspective view of a cannulated knotless anchor implant <NUM> in accordance with an embodiment is shown. The cannulated knotless anchor implant <NUM> can include an elongated body extending along a longitudinal axis between a proximal end <NUM>-<NUM> and a distal end <NUM>-<NUM>. The cannulated knotless anchor implant <NUM> can also include a screw thread <NUM>-<NUM> positioned about the exterior surface of the knotless anchor implant <NUM>. The screw thread <NUM>-<NUM> can be continuous or non-continuous, where each revolution or apparent revolution around the elongated body can be deemed a separate screw thread creating a plurality of screw threads (even though screw thread <NUM>-<NUM> may be continuous). The screw thread <NUM>-<NUM> can extend (<NUM>) from the most proximal portion of the proximal end to the most distal portion of the distal end, (<NUM>) from the most proximal portion of the proximal end to a position prior to the most distal portion of the distal end, (<NUM>) from a position between the most proximal portion of the proximal end and the most distal portion of the distal end to another position between the most proximal portion of the proximal end and the most distal portion of the distal end, or (<NUM>) any combination of the foregoing positions (or any other position on the exterior surface of the exterior portion of the cannulated knotless anchor implant <NUM>). The screw threads <NUM>-<NUM> can be positioned all the way around the exterior surface of the cannulated knotless anchor implant <NUM>, partially around the exterior surface of the cannulated knotless anchor implant <NUM> (e.g., ¼, ½, ¾, of the way around), or can include a combination thereof. Additionally, a density of a number of screw threads can vary along the exterior surface of the cannulated knotless anchor implant <NUM>. For example, the density of the number of screw threads <NUM>-<NUM> positioned about the exterior surface of the cannulated knotless anchor implant <NUM> can be greater between the proximal end <NUM>-<NUM> and about half way towards the distal end <NUM>-<NUM> as compared to the density of the number of screw threads <NUM>-<NUM>' positioned about the exterior surface of the knotless anchor implant <NUM> between about half way towards the distal end <NUM>-<NUM> and the distal end <NUM>-<NUM>. Further, the lumen <NUM>-<NUM> of the elongated body can comprise more than one diameter, e.g., the proximal end <NUM>-<NUM> can include a larger diameter than the distal end <NUM>-<NUM>. This difference in diameter size can be based on differences in shape between sections of the elongated body (e.g., conical vs. different sized cylindrical sections), or the narrowing or enlargement of the size of the lumen at any given point along the longitudinal axis based on changes in the thickness of the interior wall sections of the elongated body.

Turning to <FIG>, a perspective view of a cannulated knotless anchor implant <NUM>' in accordance with an alternative embodiment is shown. The majority of the features of cannulated knotless anchor implant <NUM>' are similar to the cannulated knotless anchor implant <NUM>. However, cannulated knotless anchor implant <NUM>' also includes at least one laterally positioned hole <NUM>-<NUM>, which is substantially transverse to the lumen <NUM>-<NUM>. A suture <NUM> is shown positioned through the hole <NUM>-<NUM>. The laterally positioned hole or holes <NUM>-<NUM> can be positioned through one portion of the exterior surface or through two portions of the exterior surface, which can be, but do not need to be, directly across from each other, and can be next to each other.

Claim 1:
A cannulated implant deployment device (<NUM>), comprising:
an elongated and cannulated driver shaft (<NUM>) extending along a longitudinal axis comprising a proximal end (<NUM>) and a distal end (<NUM>);
a cannulated implant (<NUM>) removably attached to the distal end (<NUM>) of the driver shaft (<NUM>);
a handle assembly connected to the proximal end of the driver shaft comprising a proximal handle (<NUM>) and a knob (<NUM>) positioned distally to the proximal handle (<NUM>);
a cleat (<NUM>) positioned on the driver shaft (<NUM>) distally to the knob (<NUM>), wherein the cleat (<NUM>) is structured, configured and positioned to secure a proximal end of a suture (<NUM>) extending from a distal end of the implant (<NUM>), resulting in a first applied tension value of the suture (<NUM>) extending between the proximal portion of the suture (<NUM>) and a distal portion of the suture (<NUM>) when the implant (<NUM>) is placed in a pilot hole (<NUM>) formed in a segment of bone tissue to secure the distal portion of the suture (<NUM>) within the pilot hole (<NUM>); and wherein the suture (<NUM>) is positioned through the driver shaft (<NUM>) from the distal end of the implant (<NUM>) through an aperture (<NUM>) formed in the side of the driver shaft (<NUM>) between the proximal end and the distal end of the driver shaft (<NUM>) to the cleat (<NUM>) on which it is secured, wherein the cleat (<NUM>) is connected to the driver shaft (<NUM>) such that it is configured to allow the cleat (<NUM>) to axially rotate with the driver shaft (<NUM>) and to move in the distal direction away from the knob (<NUM>) upon the axial rotation of the proximal handle (<NUM>) in the first direction and
wherein each of the implant (<NUM>), proximal handle (<NUM>) and cleat (<NUM>) is connected to the driver shaft (<NUM>) such that an axial rotation of the proximal handle (<NUM>) in a first direction results in the axial rotation of the implant (<NUM>) in the first direction and the maintenance of at least <NUM>% of the first applied tension value per the axial rotation of the handle (<NUM>) when the implant (<NUM>) is rotated in the first direction and advanced in the distal direction within the pilot hole, wherein there is a threaded connection between the shaft (<NUM>) and the knob (<NUM>).