Patent Description:
Arthroscopic procedures often require soft tissue to be reattached to bone. To achieve this, anchors are typically placed in the bone and sutures attached to the anchor are passed through the tissue to securely retain the tissue in place. Typical anchors may be pound-in or screw-in type anchors, or combination anchors having a pound-in distal tip and a screw-in proximal anchor.

Installation of combination pound-in/screw-in type anchors can be problematic due to several issues. One issue is the lack of prominent visual landmarks available to provide feedback to the user on the insertion progress of the anchor. This problem occurs both during the initial pound-in phase of the distal tip as well as during the subsequent screw-in phase of the proximal anchor. Another issue is that some current pound-in/screw-in type anchors include an internal locking plug advanceable within the tip for locking sutures within the tip eyelet. In some cases, insufficient suture retention by the locking plug can allow for the sutures to slip, and thus for the repair construct to loosen and fail.

Another problem with pound-in/screw-in type anchors is that, in instances where there are large amounts of suture loaded into the anchor tip, rotatable parts of the inserter can sometimes reach a travel limit before the screw-in anchor is fully seated into bone. In these cases, the screw-in anchor is left proud of the cortical bone surface, which can lead to irritation of adjacent tissue. This issue is more common with poor quality bone, as the partially implanted anchor cannot finish "pulling" itself into the bone without the mechanical assist of the inserter. In these instances, the bone itself begins to mechanically fail under the loads required to drive the screw-in anchor into the bone hole. Furthermore, while surgeons can choose to abrade the exposed portion of the anchor, this may cause a delay in the progress of the surgery and risk damaging the repair suture.

Another issue with pound-in/screw-in type anchors is that some handles of current anchor delivery systems have an excess of axial clearance between the component parts of the handle, giving an undesirable feeling of looseness within the handle as experienced by the user. Furthermore, if the screw-in portion of the anchor either breaks or pulls out of the bone intraoperatively, it is difficult to remove the distal tip from the repair suture in order to reload the suture into a backup anchor to complete the repair. <CIT> relates to composite interference screws and drivers; <CIT> relates to a locking suture anchor assembly; <CIT> relates to tissue repair devices; <CIT> relates to a bone anchor system having a movable medial eyelet.

Described herein are anchor delivery systems for combination pound-in/screw-in type anchors which include markings on the surfaces of the delivery device. The markings consist of countdown markers on the driver tip which are visually exposed to the user through openings or fenestrations in the screw-in portion of the anchor. The countdown markers create a countdown sequence for the user, which advantageously provides visual feedback to the user on the progress of the anchor's insertion. Also described herein is a suture-locking plug that is deformable within the anchor tip, and thereby enhances suture entrapment within the tip of the anchor. Additionally, a compliant component of the handle places the handle components in tension, thereby absorbing built-in axial looseness within the handle. In some examples, the handle further comprises a spin cavity which allows for free spin of the inserter shaft to finalize insertion of the screw-in anchor into bone when the screw-in anchor has not been fully seated flush with or below the cortical bone surface. In other examples, a length of internal threads of the delivery device is selected to allow the screw-in anchor to rotate for several turns without threading into the bone while still allowing sufficient axial travel of the screw-in anchor to fully seat into bone. Also disclosed are instruments that can be used by the surgeon to loosen the plug in the anchor tip, allowing for removal of the anchor tip from the repair suture, and to mark the site of a prepared bone hole for easy identification.

Further examples of the anchor delivery systems of this disclosure may include one or more of the following, in any suitable combination.

In examples, the anchor delivery system of this disclosure includes a sleeve body having a proximal end, a distal end, and a plurality of turns of a screw thread extending between the proximal and distal ends. The sleeve body defines an internal volume communicating with a region exterior to the sleeve body through at least one set of axially-aligned openings defined by the sleeve body between adjacent turns of the plurality of turns of screw thread along a length of the sleeve body. A delivery device has an elongated shaft having a proximal portion and a distal portion. The distal portion includes at least one ridge defined by first and second sides of the shaft. At least one of the first and second sides has a series of axially-aligned markings extending along a length of the at least one of the first and second sides. When the sleeve body is engaged with the distal portion of the shaft, each marking of the series of axially-aligned markings of the delivery device is visible through a respective opening of the at least one set of axially-aligned openings of the sleeve body, providing a user with visual feedback on insertion progress of the sleeve body into bone.

In further examples, the internal volume of the sleeve body includes at least one slot extending between the proximal and distal ends of the sleeve body. When the sleeve body is engaged with the distal portion of the shaft, the at least one ridge of the delivery device is engageable with the at least one slot of the sleeve body. In examples, the at least one slot is four slots. Each slot is spaced about <NUM>° around a surface of the internal volume of the sleeve body from another slot. In examples, the at least one set of axially-aligned openings is two sets of axially-aligned openings, and the at least one slot is positioned between the two sets of axially-aligned openings. In examples, the at least one set of axially-aligned openings is four sets of axially-aligned openings. Each set of axially-aligned openings is spaced about <NUM>° around a circumference of the sleeve body from another set of axially-aligned openings. In examples, the at least one ridge is four ridges. Each ridge is spaced about <NUM>° around a surface of the shaft of the delivery device from another ridge. In examples, the at least one set of axially-aligned markings is a set of numerals. In examples, the set of numerals includes five numerals which count down in a stepwise fashion by odd numbers from the distal end to the proximal end of the shaft. In other examples, the set of numerals includes four numerals which count down in a stepwise fashion by even numbers from the distal end to the proximal end of the shaft. In examples, the at least one set of axially-aligned openings is five axially-aligned openings. In other examples, the at least one set of axially-aligned openings is four axially-aligned openings.

In further examples, the anchor delivery system of this disclosure includes a tip having a distal portion and a proximal portion. The proximal portion defines a cavity therein with a wall of the cavity having threads. An eyelet is defined in the distal portion of the tip in communication with the cavity. A plug has a threaded outer portion and an internal cannulation configured for receipt of an inner shaft of a delivery device. The plug is disposed within the cavity of the tip such that threads of the threaded outer portion are engaged with the threads of the cavity. The plug is rotatable and axially moveable through the cavity by rotation of the inner shaft to engage a suture threaded through the eyelet. When the inner shaft of the delivery device is disposed within the cannulation of the plug, a length of the inner shaft is selected such that a gap is formed between a distal end of the inner shaft and a distal end of the cannulation. The gap provides a crushable zone such that a distal end of the plug is deformable when the plug is engaged with the suture in the eyelet. In yet further examples, a proximal portion of the plug extends from the cavity of the tip. In other examples, the tip is coupled to an intermediate shaft of the delivery device such that the inner shaft extends through the intermediate shaft. In further examples, the plug includes a non-threaded outer portion. The non-threaded outer portion is distal to the threaded outer portion.

In other examples, the anchor delivery system of this disclosure includes a handle assembly including a handle grip. An outer shaft extends from a distal end of the handle assembly. A proximal end of the outer shaft is coupled to an outer shaft hub. A sleeve advancement member is at least partially disposed within the handle assembly. A proximal end of the sleeve advancement member defines a rotatable knob adjacent a proximal end of the handle assembly. A distal end of the sleeve advancement member is operatively coupled to the outer shaft hub such that rotation of the rotatable knob causes rotational movement of the outer shaft. A drive housing is at least partially disposed within the sleeve advancement member. An anti-rotation member is coupled to the handle grip and the drive housing for preventing rotation of the handle grip during rotation of the rotatable knob. A length and stiffness of the anti-rotation member is selected to force the drive housing, the sleeve advancement member and the handle grip into axial contact to eliminate axial looseness in the handle assembly.

In other examples, an anchor delivery system of this disclosure includes a handle assembly including a handle grip. An outer shaft extends from a distal end of the handle assembly. A proximal end of the outer shaft is coupled to an outer shaft hub. A sleeve advancement member is at least partially disposed within the handle assembly. A proximal end of the sleeve advancement member defines a rotatable knob adjacent a proximal end of the handle assembly. A distal end of the sleeve advancement member is operatively coupled to a center housing having internal threads configured to engage outer threads on the outer shaft hub, such that rotation of the rotatable knob causes rotational movement of the outer shaft. At an end of an axial travel limit of the outer shaft hub along the internal threads of the center housing, the outer shaft hub is configured to freely rotate within a non-threaded portion of the center housing. In further examples, the system includes an anti-rotation member coupled to the handle grip and a drive housing at least partially disposed within the sleeve advancement member. The anti-rotation member is configured to prevent rotation of the handle grip during rotation of the rotatable knob.

In further examples, an anchor delivery system of this disclosure includes a handle assembly including a handle grip. A first shaft is coupled to the handle assembly. A proximal end of the first shaft coupled to a hub and a distal end of the first shaft is coupled to an anchor sleeve. A second shaft extends through the first shaft. A distal end of the second shaft is coupled to a tip having a proximal portion and a distal portion. A sleeve advancement member is at least partially disposed within the handle assembly. A proximal end of the sleeve advancement member defines a rotatable knob adjacent a proximal end of the handle assembly. A distal end of the sleeve advancement member is operatively coupled to a center housing having internal threads configured to engage outer threads on the hub such that rotation of the rotatable knob causes rotational movement of the first shaft. A length of the internal threads of the center housing is selected to exceed a distance between a distal end of the anchor sleeve and the distal portion of the tip.

The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:.

In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.

As used in the specification and claims, for the purposes of describing and defining the invention, the terms "about" and "substantially" are used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. "Comprise," "include," and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. "And/or" is open-ended and includes one or more of the listed parts and combinations of the listed parts.

For a better understanding of the current disclosure, <FIG> and <FIG> depict a prior art anchor delivery system <NUM> for securing a tissue to bone. As shown in <FIG>, the anchor delivery system <NUM> generally includes a screw-in type anchor sleeve <NUM> and a pound-in type tip <NUM>. In examples, the anchor sleeve <NUM> includes a plurality of turns of a screw thread <NUM> having a plurality of openings <NUM> between turns of the plurality of turns of a screw thread <NUM> for allowing bony ingrowth from the bone into an internal volume defined within the plurality of turns of a screw thread <NUM>. In examples, the tip <NUM> includes a suture capture member, such as a plug (not shown), advanceable through an internal cavity of the tip <NUM> to lock one or more sutures in an eyelet 102a extending through the tip <NUM>. In examples, the tip <NUM> may include barbs <NUM> protruding therefrom to improve pullout strength of the tip <NUM>. However, in other examples, the tip <NUM> may be smooth-sided. In examples, the anchor sleeve <NUM>, the tip <NUM> and the plug can be constructed from polymers (e.g., PEEK), bioabsorbable materials, metals (e.g., surgical steel, titanium), or any other suitable material.

As shown in more detail in <FIG>, the anchor sleeve <NUM> and the tip <NUM> can be installed into bone using a delivery device <NUM>. The delivery device <NUM> generally includes an outer shaft <NUM> for engaging with the anchor sleeve <NUM>, an inner shaft <NUM> for engaging with the plug of the tip <NUM>, and a handle assembly <NUM> for holding and operating the delivery device <NUM>. In examples, the delivery device <NUM> can also include one or more intermediate shafts <NUM> to provide additional stiffness when pounding in the tip <NUM>. In examples, the internal volume of the anchor sleeve <NUM> may comprise longitudinal ribs to engage grooves or slots <NUM> extending along the outer shaft <NUM>. In other examples, the outer shaft <NUM> may comprise longitudinal ribs (not shown) to engage recesses extending through the internal volume of the anchor sleeve <NUM>. In some examples, the anchor sleeve <NUM> is screwed or otherwise advanced by the outer shaft <NUM> into bone over a proximal end of the tip <NUM> by rotation of a sleeve advancement member <NUM>. In examples, a suture capture knob <NUM> is operatively coupled to a proximal end of the inner shaft <NUM> such that rotating or twisting the suture capture knob <NUM> causes the inner shaft <NUM> to advance the plug within the eyelet 102a of the tip <NUM>. Additional non-limiting examples of anchor delivery systems can be found in <CIT>. (Memphis, TN).

Turning now to <FIG>, an example of an anchor delivery system <NUM> of this disclosure is shown in an exploded, perspective view. The anchor delivery system <NUM> may be used to insert an anchor sleeve <NUM> and a tip, such as tip <NUM>, into bone. As shown in <FIG>, the anchor delivery system <NUM> includes a delivery device <NUM> having an outer shaft <NUM> for engaging with the anchor sleeve <NUM>. The anchor sleeve <NUM> comprises a substantially cylindrical sleeve body <NUM> having a proximal end 210a, a distal end 210b, and a plurality of turns of a screw thread <NUM> extending between the proximal end 210a and the distal end 210b. In examples, the distal end 210b of the sleeve body <NUM> can include a non-threaded portion, as shown. The sleeve body <NUM> defines an internal volume <NUM> which communicates with an exterior of the sleeve body <NUM> through at least one set axially-aligned openings <NUM> defined by the portions of the sleeve body <NUM> extending between adjacent turns of the screw thread <NUM>. In examples, four sets of axially-aligned openings <NUM> are defined by the sleeve body <NUM>. However, more or fewer than four sets of axially-aligned openings <NUM> are contemplated by this disclosure. Each set of axially-aligned openings <NUM> are spaced about <NUM>° from another set of axially-aligned openings <NUM> around a circumference of the sleeve body <NUM>. The sleeve body <NUM> also includes at least one slot <NUM> disposed within the internal volume <NUM> and extending between the proximal end 210a and the distal end 210b of the sleeve body <NUM>. In examples, the sleeve body <NUM> includes four slots <NUM>. However, more or fewer than four slots <NUM> are contemplated by this disclosure. Each slot <NUM> is spaced about <NUM>° from another slot <NUM> around a surface of the interior volume <NUM> and is disposed between adjacent sets of axially-aligned openings <NUM>.

Still referring to <FIG>, the outer shaft <NUM> of the delivery device <NUM> includes a proximal portion 217a and a distal portion 217b. An outer surface of the distal portion 217b includes a plurality of ridges <NUM> extending a length of the distal portion 217b. In examples, the distal portion 217b includes four ridges <NUM>. However, more or fewer than four ridges <NUM> are contemplated by this disclosure. Each ridge <NUM> is spaced about <NUM>° from another ridge <NUM> around an outer surface of the outer shaft <NUM> and is defined by two substantially flat sides <NUM>, <NUM> extending along a length of the ridge <NUM>. Side <NUM> includes a first set of axially-aligned, laser-marked numerals <NUM>, while side <NUM> includes a second set of axially-aligned, laser-marked numerals <NUM>, the purpose of which will be described in more detail below. Each ridge <NUM> is configured to engage a respective slot <NUM> of the anchor body <NUM> when the distal portion 217b of the delivery device <NUM> is inserted into the interior volume <NUM> of the anchor body <NUM>.

Turning now to <FIG>, a detailed view of the sleeve body <NUM> and the distal portion 217b of the delivery device <NUM> is shown in an assembled view. In <FIG>, the first set of laser marked numerals <NUM>, which may be five numerals <NUM>, on the side <NUM> of the delivery device <NUM>, are visible through a first set of axially-aligned openings <NUM> of the sleeve body <NUM>. The first set of numerals <NUM> count down in a stepwise fashion by odd numbers (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) from the distal end 210b to the proximal end 210a of the sleeve body <NUM>. <FIG> shows the sleeve body <NUM> of <FIG> rotated clockwise by about <NUM>/<NUM>th of a turn. As seen in <FIG>, the second set of laser marked numerals <NUM>, which may be four numerals, on the side <NUM> of the delivery device <NUM>, are visible through a second set of axially-aligned openings <NUM> of the sleeve body <NUM>. The second set of numerals <NUM> count down in a stepwise fashion by even numbers (e.g., <NUM>, <NUM>, <NUM>, <NUM>) from the distal end 210b to the proximal end 210a of the sleeve body <NUM>. In use, as the sleeve body <NUM> is inserted into bone via rotation of the outer shaft <NUM>, the first set of numerals <NUM> and second set of numerals <NUM> give the user visual feedback that the sleeve body <NUM> is inserting into bone, rather than merely free-spinning.

It will be appreciated that, if the sleeve body <NUM> of <FIG> were again rotated clockwise, a third set of laser marked numerals, which may be five numerals, on an opposite side of the delivery device <NUM> from side <NUM>, would be visible through a third set of axially-aligned openings <NUM> of the sleeve body <NUM>. The third set of numerals would count down in a stepwise fashion by odd numbers from the distal end 210b to the proximal end 210a of the sleeve body <NUM>. If the sleeve body <NUM> of <FIG> were further rotated clockwise, a fourth set of laser marked numerals, which may be four numerals, on an opposite side of the delivery device <NUM> from side <NUM>, would be visible through a fourth set of axially-aligned openings <NUM> of the sleeve body <NUM>. The fourth set of numerals would count down in a stepwise fashion by even numbers from the distal end 210b to the proximal end 210a of the sleeve body <NUM>. It is also contemplated by this disclosure that, rather than numerals, other visual markings could be used to indicate the insertion progress of the anchor body <NUM> into bone. For example, the markings could be a sequence of alternating characters, such as dots and dashes. In other examples, the markings could be a sequence of dots of changing size, number and/or shape. In further examples, the markings could be a series of dash lines with a changing azimuth angle.

Turning now to <FIG>, examples of a tip <NUM>, an inner shaft <NUM>, an intermediate shaft <NUM>, and a locking plug <NUM> are illustrated in a cross-sectional, detailed view. In examples, the tip <NUM> includes a distal portion 302c and a proximal portion 302b. A tip cavity 302d is defined within the proximal portion 302b of the tip <NUM> and is configured to receive the plug <NUM> through an opening in the proximal portion 302b. The eyelet 302a extends through the distal portion 302c of the tip <NUM> and is in communication with the tip cavity 302d. In examples, a distal end of the tip <NUM> may be pointed as shown, for creation of a bone hole. However, it contemplated by this disclosure that the distal end of the tip <NUM> may be blunt in cases where a bone hole is created prior to insertion of the tip <NUM>. The plug <NUM> includes an internal cannulation 313b extending through the plug <NUM>, while an outer surface of the plug <NUM> includes threads 313a. In examples, the threads 313a extend an entire length of the plug <NUM>. In other examples, as shown, only a proximal portion of the plug <NUM> is threaded, while a distal portion of the plug <NUM> is unthreaded. The tip cavity 302d includes threads 302e that engage the threads 313a of the plug <NUM> upon insertion of a portion of the plug <NUM> into the tip cavity 302d. In examples, the remainder of the plug <NUM> extends outside of the tip cavity 302d.

Still referring to <FIG>, when engaged with the delivery device, the proximal portion 302b of the tip <NUM> is coupled to the intermediate shaft <NUM>, and the inner shaft <NUM> extends through the intermediate shaft <NUM> for engagement with the internal cannulation 313b of the plug <NUM>. In examples, the internal cannulation 313b of the plug <NUM> and a mating portion of the inner shaft <NUM> having a corresponding geometry, such as a hexagonal shape. During tissue repair, sutures <NUM> attached to soft tissue (not shown) are placed through the eyelet 302a of the tip <NUM>. A length of the inner shaft <NUM> is selected such that a gap or void <NUM> (<FIG>) is formed between the distal end of the inner shaft <NUM> and the distal end of the internal cannulation 313b of the plug <NUM>. The void <NUM> may be empty of material, or may be filled with a material having a lower density than the plug <NUM>. The void <NUM> thus provides a crushable zone at the distal end of the plug <NUM> which allows the distal end of the plug <NUM> to be deformable. In use, the tip <NUM> is placed within a bone hole (not shown) via axial advancement, such as malleting, of the delivery device. The suture capture knob <NUM> of the delivery device <NUM> (<FIG>) is rotated to move the plug <NUM> via the inner shaft <NUM> distally into the eyelet 302a where the plug <NUM> encounters the sutures <NUM>. As the plug <NUM> and the inner shaft <NUM> are descended further into the eyelet 302a, the plug <NUM> impinges on the sutures <NUM> with a force sufficient to deform the distal end of the plug <NUM> around the sutures <NUM>, thus allowing for more surface contact between the sutures <NUM> and the plug <NUM>. The increased surface contact between the plug <NUM> and the sutures <NUM> advantageously allows for more friction and holding force on the sutures <NUM> by the plug <NUM> within the eyelet 302a.

Turning now to <FIG>, an example of an anchor delivery system <NUM> of this disclosure is shown in a perspective, exploded view. The anchor delivery system <NUM> may be used to insert an anchor sleeve <NUM> and a tip <NUM> into bone. As shown in <FIG>, the anchor delivery system <NUM> includes an outer shaft <NUM> for engaging with the sleeve <NUM>, and an intermediate shaft <NUM> extending through the outer shaft <NUM> for engaging with the tip <NUM>. A proximal end of the outer shaft <NUM> is coupled to an outer shaft hub <NUM>. The outer shaft hub <NUM> in turn is configured to be threadingly coupled to a center housing <NUM>. The anchor delivery system <NUM> also includes a drive housing <NUM> for holding the intermediate shaft <NUM>. The anchor delivery system <NUM> furthermore includes a suture capture knob <NUM> coupled to the inner shaft <NUM> for advancing the plug <NUM> within the tip <NUM>, a sleeve advancement member <NUM> for screwing the anchor sleeve <NUM> into bone, and a handle grip <NUM> for holding and/or maneuvering the anchor delivery system <NUM> during insertion of the anchor sleeve <NUM> into bone. A spring <NUM> is configured to be disposed within the drive housing <NUM> to allow a relative motion between the outer shaft <NUM> and the inner shaft <NUM>, thereby absorbing at least a portion of the impact forces exerted on the sleeve <NUM> during the pounding-in of the tip structure <NUM>. The anchor delivery system <NUM> may also include an anti-rotation feature, such as a bridge <NUM>, which is described in more detail below.

<FIG> shows the internal components of the handle assembly <NUM> of the delivery device <NUM> of <FIG> in a cross-sectional view. In particular, <FIG> shows the sleeve advancement member <NUM> and the handle grip <NUM>. A proximal end of the sleeve advancement member <NUM> defines a rotatable knob 411a extending outside of the handle grip <NUM> near the proximal end of the handle assembly <NUM>. In examples, a proximal portion 430a of the center housing <NUM> may have internal threads 430c for engaging threads 423a on an outer surface of the outer shaft hub <NUM>. A distal portion 430b of the center housing <NUM> may be unthreaded, forming a "spin cavity" <NUM>, the purpose of which will be described in more detail below. The outer shaft hub <NUM> can be further engaged with a distal end 411b of the sleeve advancement member <NUM>. Thus, twisting or rotating the sleeve advancement member <NUM> via the rotatable knob 411a rotates the outer shaft hub <NUM>, thereby causing the outer shaft hub <NUM> to advance distally along the threads 430c of the center housing <NUM> and, consequently, to cause the outer shaft <NUM> to advance the sleeve <NUM> into engagement with bone and/or the tip <NUM>.

Still referring to <FIG>, the bridge <NUM> is configured to stabilize the handle grip <NUM> to the drive housing <NUM>, preventing the handle grip <NUM> from rotating during rotation of the sleeve advancement member <NUM>. In their natural state, the bridge <NUM>, the drive housing <NUM>, the sleeve advancement member <NUM> and the handle grip <NUM> have built-in axial clearances to prevent these components from binding during use. Therefore, in the handle assembly <NUM> of this disclosure, a length of the bridge <NUM> is selected to place the bridge <NUM> in compression, like a spring. This compression causes the axial clearances between the components to be absorbed as the drive housing <NUM>, the sleeve advancement member <NUM> and the handle grip <NUM> are forced into axial contact. Specifically, the force generated by the bridge <NUM> being placed in compression forces the drive housing <NUM> and the handle grip <NUM> away from each other. The force generated by the bridge <NUM> being placed in compression is counteracted in the flexure joint between the sleeve advancement member <NUM> and the drive housing <NUM>, and in the flexure joint between the handle grip <NUM> and the sleeve advancement member <NUM>. The quantity of the axial force exerted by the bridge <NUM> is a function of the amount of built-in interference between the bridge <NUM> and the other components and by the stiffness of the bridge <NUM>. Thus, a stiffness of the bridge <NUM> is selected such that a range of acceptable, non-zero axial loads are generated by the handle assembly <NUM> with the currently defined component tolerances. These generated axial loads advantageously remove axial clearance from the components of the handle assembly <NUM>, thus eliminating a feeling of looseness in the handle assembly <NUM> as experienced by the user. It is also contemplated by this disclosure that other compression mechanisms than the bridge <NUM> could be used to axially load the handle assembly <NUM>. In addition, the amount of interference could be set on each individual handle assembly <NUM> with shims (not shown) to closely tune the compression force and feel of each individual handle assembly <NUM>.

Turning now to <FIG>, in some cases, some of the available travel of the outer shaft hub <NUM> within the center housing <NUM> is consumed while the anchor sleeve <NUM> spins at the bone surface without entering the bone. This can prevent the anchor sleeve <NUM> from being fully seated flush with or below the cortical bone surface, which is the desired outcome. Thus, in the handle assembly <NUM> of this disclosure, at the end of the distal travel of the outer shaft hub <NUM> within the center housing <NUM>, the outer shaft hub <NUM> is configured to fully unthread from the threads of the center housing <NUM> and freely rotate within the spin cavity <NUM>. If the anchor sleeve <NUM> has not been fully seated flush with or below the cortical surface of bone, the free rotation of the outer shaft hub <NUM> within the spin cavity <NUM> may be sufficient to complete the insertion of the anchor sleeve <NUM> into bone. It is further contemplated that the threads may be entirely eliminated from both of the center housing <NUM> and the outer shaft hub <NUM>, and that the free spinning of the outer shaft hub <NUM> within the center housing <NUM> is sufficient to insert the anchor sleeve <NUM> into bone.

Turning to <FIG>, another example of a handle assembly <NUM> of this disclosure is shown in a cross-sectional view. In the handle assembly <NUM>, a length L of the threads 530c of the center housing <NUM> is selected to exceed a staging distance D between the distal end of the anchor sleeve <NUM> and the distal portion 502c of the tip <NUM> (<FIG>). The length L of the threads 530c allows the anchor sleeve <NUM> to undergo more handle-driven advancement, helping to address the issue of leaving the anchor sleeve <NUM> proud of the bone or tissue. In use, the user first inserts the tip <NUM> into a bone hole. The user then activates the plug (for example, plug <NUM>, <NUM>) into the tip <NUM> prior to inserting the anchor sleeve <NUM> into engagement with the tip <NUM>. Activating the plug releases the tip <NUM> from the intermediate shaft <NUM> of the delivery device <NUM>. If the anchor sleeve <NUM> rotates without inserting into bone, the mechanical action of the delivery device <NUM> will withdraw the intermediate shaft <NUM> from the bone hole. However, because the tip <NUM> has been released from the intermediate shaft <NUM>, the tip <NUM> generally remains at its fully deployed, distal location. The user can then rotate the anchor sleeve <NUM> without the anchor sleeve <NUM> threading into the bone for several turns of the sleeve advancement member <NUM> without fear of running out of mechanically assisted axial travel from the delivery device <NUM>. In examples, the threads 530c of the center housing <NUM> can be longer or shorter as long as the total length L of the threads 530c exceeds the distance D between the anchor sleeve <NUM> and the distal portion 502c of the tip <NUM>.

Turning now to <FIG>, an example of an unlocking instrument <NUM> of this disclosure for use with the anchor delivery systems <NUM>, <NUM>, <NUM> is shown in a side view. The unlocking instrument <NUM> is configured for removing a tip <NUM> from a suture <NUM> after the tip <NUM> has been deployed into bone. The unlocking instrument <NUM> has a similar working length to the working lengths of the anchor delivery systems <NUM>, <NUM>, <NUM> described above. As shown in <FIG>, the unlocking instrument <NUM> comprises a handle <NUM> and a shaft <NUM> extending from the handle <NUM>. In examples, the handle <NUM> is made for single-use and is comprised of injection molded plastic. In other examples, the handle <NUM> is reusable and comprised of stainless steel. A distal end of the shaft <NUM> comprises a hex feature <NUM> configured to mate with the hexagonal cannulation 613b of the plug <NUM> (<FIG>). Thus, the unlocking instrument <NUM> is used to loosen the contact between the plug <NUM> and the suture <NUM> secured within the tip <NUM>, allowing for removal of the tip <NUM> from the suture <NUM>.

Turning now to <FIG>, in use, an instrument such as a grasper tool <NUM> is introduced into a repair site in which, for example, the anchor sleeve <NUM> has broken after insertion into bone. The tip <NUM> is held with the grasper tool <NUM> to stabilize the tip <NUM> during removal of the plug <NUM>. The unlocking instrument <NUM> is then inserted into the proximal end 602b of the tip <NUM>. As shown in <FIG>, the hex feature <NUM> of the unlocking instrument <NUM> is then engaged with the cannulation 613b of the plug <NUM>. Once the unlocking instrument <NUM> is engaged with the plug <NUM>, the unlocking instrument <NUM> is rotated to loosen the contact between the plug <NUM> and the suture <NUM> which has been threaded through the eyelet 602a. With the plug <NUM> loosened, the user can use the grasper tool <NUM> (or other means) to hold and slide the tip <NUM> off of the suture <NUM> and retrieve the tip <NUM> from the repair site. The user is then free to use a replacement anchor sleeve/tip with the suture <NUM> to complete the repair. It is also contemplated by this disclosure that the unlocking instrument <NUM> could also include a mechanism (not shown) for gripping the tip <NUM> during removal of the plug <NUM>.

Turning now to <FIG>, an example of a hole preparation tool <NUM> of this disclosure for use with the anchor delivery systems <NUM>, <NUM>, <NUM> is shown in a side view (<FIG>) and a detailed view (<FIG>). As shown in <FIG>, the hole preparation tool <NUM> includes a handle grip <NUM> and a shaft <NUM> extending from the handle grip <NUM>. In examples, the shaft <NUM> includes a distal pointed tip <NUM> for piercing bone. A threaded portion <NUM> of the hole preparation tool <NUM> may include a plurality of turns of a screw thread <NUM> for pre-tapping a bone hole before insertion of a threaded anchor sleeve. The hole preparation tool <NUM> also includes a marking element <NUM> disposed around the shaft <NUM> adjacent to a proximal end 710a of the threaded portion <NUM>. In examples, the marking element <NUM> comprises an absorbent material pre-saturated with surgical ink. In examples, the marking element <NUM> has an annular shape, as shown. However, the disclosure contemplates other suitable shapes of the marking element <NUM>, including two half-annuli. As shown in <FIG>, to protect the tip <NUM> from puncturing surrounding packaging and to protect the marking element <NUM> from drying out, a protective cap <NUM> covers the tip <NUM> as well as the marking element <NUM> of the bone preparation tool <NUM>.

<FIG> illustrate an example using the hole preparation tool <NUM> in a surgical repair. As shown in <FIG>, a surgeon first inserts the tip <NUM> of the hole preparation tool <NUM> into bone <NUM>. Next, as shown in <FIG>, the surgeons rotates the hole preparation tool <NUM> to advance the threaded portion <NUM> into the bone <NUM> until the marking element <NUM> comes into contact with the surface of the bone <NUM>. When the marking element <NUM> contacts the surface of the bone <NUM>, the marking element <NUM> marks the bone <NUM> with ink. As shown in <FIG>, the surgeon then unthreads the hole preparation tool <NUM> and removes it from the repair site, leaving behind a prepared bone hole <NUM> and an ink mark <NUM> identifying the location of the prepared bone hole <NUM> (<FIG>). The disclosure also contemplates other methods of marking the bone hole <NUM>, including using radio-frequency energy.

Claim 1:
An anchor delivery system comprising:
a tip (<NUM>) comprising a distal portion (302c) and a proximal portion (302b), the proximal portion (302b) defining a cavity (302d) therein with a wall of the cavity (302d) having threads (302e), and an eyelet (302a) defined in the distal portion (302c) of the tip (<NUM>) in communication with the cavity (302d); and
a plug (<NUM>) having a threaded outer portion and an internal cannulation (313b) configured for receipt of an inner shaft (<NUM>) of a delivery device, the plug (<NUM>) disposed within the cavity (302d) of the tip (<NUM>) such that threads (313a) of the threaded outer portion are engaged with the threads (302e) of the cavity (302d), the plug (<NUM>) being rotatable and axially moveable through the cavity (302d) by rotation of the inner shaft (<NUM>) to engage a suture threaded through the eyelet(302a); and
wherein, when the inner shaft (<NUM>) of the delivery device is disposed within the cannulation (313b) of the plug (<NUM>), a length of the inner shaft (<NUM>) is selected such that a gap (<NUM>) is formed between a distal end of the inner shaft (<NUM>) and a distal end of the cannulation (313b),
characterized by the gap (<NUM>) providing a crushable zone such that a distal end of the plug (<NUM>) is deformable when the plug (<NUM>) is engaged with the suture in the eyelet (302a).