Anchor Delivery System

Abstract

To provide anchor delivery systems which include markings on surfaces of delivery device which are visually exposed to a user through openings or fenestrations in an anchor, providing visual feedback to the user on progress of the anchor's insertion.SOLUTION: A suture-locking plug is deformable within a tip of the anchor, thereby enhancing suture entrapment within the tip of the anchor. A component compliant with a handle places handle components in tension, thereby absorbing built-in axial looseness in the handle. The handle further includes a spin cavity which allows free spin of an inserter shaft to finalize insertion of the anchor into bone when the anchor has not been fully seated flush with or below the cortical bone surface.SELECTED DRAWING: Figure 2A

Description

[Background technology]

[0001] REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 993,322, entitled "ANCHOR DELIVERY SYSTEMS," filed March 23, 2020, and U.S. Provisional Patent Application No. 63 / 009,632, entitled "AUTO-MARKING HOLE PREPARATION TOOL," filed April 14, 2020, the entire contents of each of which are incorporated herein by reference for all purposes.

[0002] Arthroscopic procedures often require soft tissue to be reattached to the bone. To accomplish this, anchors are typically placed into the bone and sutures attached to the anchors are passed through the tissue to hold the tissue securely in place. Typical anchors may be hammered or threaded anchors, or combination anchors with a hammered distal tip and a threaded proximal anchor.

[0003] Installation of combination hammer-in / screw-in anchors can be tricky due to several issues. One issue is that there are no prominent visual cues available to provide feedback to the user on the anchor's insertion progress. This issue arises both during the initial hammering phase of the distal tip, as well as during the subsequent screwing phase of the proximal anchor. Another issue is that some current hammer-in / screw-in anchors include an internal locking plug advanceable within the tip to lock the suture within the tip eyelet. In some cases, insufficient suture retention by the locking plug can allow the suture to slip out, thus allowing the repair construct to loosen and fall off.

[0004] Another problem with hammered / screwed anchors is that if the tip of the anchor is loaded with a large amount of suture, the inserter's rotatable part may reach its travel limit before the threaded anchor is fully secured in the bone. In these cases, the threaded anchor remains protruding from the cortical bone surface, which may lead to irritation of adjacent tissue. This problem is more prevalent in poor quality bone, as the partially implanted anchor is unable to finish "pulling" itself into the bone without the mechanical assistance of the inserter. In these instances, the bone itself begins to mechanically weaken under the loads required to drive the threaded anchor into the bone hole. Additionally, the surgeon may choose to wear down the exposed portion of the anchor, which may cause a delay in the surgical progress and risk of damage to the repair sutures.

[0005] Another problem with hammered / screwed anchors is that the handles of some current anchor delivery systems have excessive axial clearance between the component parts of the handle resulting in an undesirable feeling of looseness in the handle experienced by the user. Additionally, if the threaded portion of the anchor either breaks or pulls out of the bone intraoperatively, it is difficult to remove the distal tip from the repair sutures in order to reload the sutures into a backup anchor to complete the repair. Summary of the Invention

[0006] Described herein is a combination hammer-in / screw-in anchor delivery system that includes markings on the surface of the delivery device. The markings consist of countdown markers on the driver tip that are visually exposed to the user through an opening or fenestration in the threaded portion of the anchor. The countdown markers create a countdown sequence for the user, which advantageously provides visual feedback to the user on the insertion progress of the anchor. Also described herein is a suture locking plug that is deformable within the anchor tip, thus enhancing containment of the suture within the anchor tip. Additionally, the handle compliant components tension the handle components, thereby absorbing inherent axial slack within the handle. In some embodiments, the handle further comprises a spinning cavity that allows free spinning of the inserter shaft to complete insertion of the threaded anchor into the bone when the threaded anchor is not fully secured flush or below the cortical bone surface. In other embodiments, the length of the internal thread of the delivery device is selected so that the threaded anchor can be rotated through several turns without penetrating the bone, while still being able to advance the threaded anchor axially sufficiently to be fully secured within the bone. Also disclosed is an instrument that can be used to loosen a plug in the anchor tip to allow the surgeon to remove the anchor tip from the repair suture, and to mark the site of the drilled bone hole for easy identification.

[0007] Further embodiments of the anchor delivery system of the present disclosure may include one or more of the following in any suitable combination:

[0008] In an embodiment, the anchor delivery system of the present disclosure includes a sleeve body having a proximal end, a distal end, and a plurality of turns of a helical thread extending between the proximal and distal ends. The sleeve body defines an interior volume that communicates with an exterior region of 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 the helical thread along the length of the sleeve body. The delivery device has an elongate 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 the length of at least one of the first and second sides. When the sleeve body is engaged with the distal portion of the shaft, each of the series of axially aligned markings on the delivery device is visible through a respective opening of at least one set of axially aligned openings on the sleeve body, providing visual feedback to the user as to the insertion progress of the sleeve body into the bone.

[0009] In a further embodiment, the interior 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 an embodiment, the at least one slot is four slots. Each slot is spaced about 90° from another slot around the surface of the interior volume of the sleeve body. In an embodiment, 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 an embodiment, 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 90° around the circumference of the sleeve body from another set of axially aligned openings. In an embodiment, the at least one ridge is four ridges. Each ridge is spaced about 90° from another ridge around the surface of the shaft of the delivery device. In an embodiment, at least one set of axially aligned markings is a set of numbers. In an embodiment, the set of numbers includes five numbers, counting down in a stepped manner by odd numbers from the distal end to the proximal end of the shaft. In another embodiment, the set of numbers includes four numbers, counting down in a stepped manner by even numbers from the distal end to the proximal end of the shaft. In an embodiment, at least one set of axially aligned openings is five axially aligned openings. In another embodiment, at least one set of axially aligned openings is four axially aligned openings.

[0010] In a further embodiment, the anchor delivery system of the present 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 a thread. 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 inner cannula configured to receive an inner shaft of a delivery device. The plug is disposed in the cavity of the tip such that the threads of the threaded outer portion engage the threads of the cavity. The plug is rotatable and axially movable 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 cannula 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 cannula. The gap provides a collapsible zone such that the distal end of the plug is deformable when engaging the suture in the eyelet. In yet a further embodiment, the proximal portion of the plug extends from a cavity in the tip. In other embodiments, the tip is coupled to a midshaft of a delivery device whereby the inner shaft extends through the midshaft. In a further embodiment, the plug includes an unthreaded outer portion. The unthreaded outer portion is distal to the threaded outer portion.

[0011] In another embodiment, the anchor delivery system of the present 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 advancing member is at least partially disposed within the handle assembly. A proximal end of the sleeve advancing member defines a rotatable knob adjacent the proximal end of the handle assembly. A distal end of the sleeve advancing 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 advancing member. An anti-rotation member is coupled to the handle grip and the drive housing to prevent 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 advancing member, and the handle grip into axial contact to eliminate axial slack in the handle assembly.

[0012] In another embodiment, the anchor delivery system of the present 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 advancing member is at least partially disposed within the handle assembly. A proximal end of the sleeve advancing member defines a rotatable knob adjacent the proximal end of the handle assembly. The distal end of the sleeve advancing member is operably coupled to a central housing having an internal thread configured to engage an external thread on the outer shaft hub such that rotation of the rotatable knob causes the outer shaft to move in a rotational direction. At an end of an axial travel limit of the outer shaft hub along the internal thread of the central housing, the outer shaft hub is configured to rotate freely within an unthreaded portion of the central housing. In a further embodiment, the system includes an anti-rotation member coupled to the handle grip and a drive housing at least partially disposed within the sleeve advancing member. The anti-rotation member is configured to prevent rotation of the handle grip during rotation of the rotatable knob.

[0013] In a further embodiment, the anchor delivery system of the present 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 the hub and a distal end of the first shaft coupled to the 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 the proximal end of the handle assembly. A distal end of the sleeve advancement member is operably coupled to a central housing having an internal thread configured to engage with an external thread on the hub such that rotation of the rotatable knob causes the first shaft to move in a rotational direction. A length of the internal thread of the central housing is selected to exceed a distance between a distal end of the anchor sleeve and a distal portion of the tip.

[0014] These and other features and advantages will be apparent from a review of the following detailed description and associated drawings. It is to be understood that both the foregoing general description and the following detailed description are intended to be illustrative and are not restrictive of aspects of the claimed subject matter. [Brief description of the drawings]

[0015] The present disclosure will become more fully understood by reference to the detailed description in conjunction with the following figures. [Figure 1A] FIG. 1 illustrates a prior art anchor delivery system. [Figure 1B] FIG. 1 illustrates a prior art anchor delivery system. [Figure 2A] 1 is an exploded view illustrating an anchor sleeve portion of the anchor delivery system of the present disclosure; FIG. [Figure 2B] 2B is an assembly view illustrating the anchor sleeve portion of FIG. 2A in detail. [Figure 2C]2B is an assembly view illustrating the anchor sleeve portion of FIG. 2A in detail. [Figure 3A] 13 is a cross-sectional view illustrating in detail a distal tip portion of another embodiment of the anchor delivery system of the present disclosure. [Figure 3B] 13 is a cross-sectional view illustrating in detail a distal tip portion of another embodiment of the anchor delivery system of the present disclosure. [Figure 4A] FIG. 13 is an exploded view illustrating another embodiment of an anchor delivery system of the present disclosure. [Figure 4B] 4B is a cross-sectional view illustrating a handle assembly of the anchor delivery system of FIG. 4A. [Figure 4C] 4B is a cross-sectional view illustrating a handle assembly of the anchor delivery system of FIG. 4A. [Figure 5A] 14 illustrates another handle assembly of the anchor delivery system of the present disclosure. [Figure 5B] 14 illustrates another handle assembly of the anchor delivery system of the present disclosure. [Figure 6A] 13A-13C illustrate an unlocking tool for use with the anchor delivery system of the present disclosure. [Figure 6B] 13A-13C illustrate an unlocking tool for use with the anchor delivery system of the present disclosure. [Figure 6C] 6C is a diagram illustrating the use of the unlocking tool of FIG. 6A and FIG. 6B. [Figure 6D] 6C is a diagram illustrating the use of the unlocking tool of FIG. 6A and FIG. 6B. [Figure 7A] 14A-14C illustrate a drilling tool for use with the anchor delivery system of the present disclosure. [Figure 7B] 14A-14C illustrate a drilling tool for use with the anchor delivery system of the present disclosure. [Figure 7C] 14A-14C illustrate a drilling tool for use with the anchor delivery system of the present disclosure. [Figure 7D] 7A to 7C. FIG. [Figure 7E]7A to 7C. FIG. [Figure 7F] 7A to 7C. FIG. [Figure 7G] 7A to 7C. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] In the following description, similar components are given the same reference numbers, whether shown in different embodiments. To illustrate the embodiment(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in some schematic form. Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments, and / or in combination with or instead of features of the other embodiments.

[0017] As used herein and in the claims, for the purpose of describing and defining the present invention, the terms "about" and "substantially" are used to express the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to express the degree to which a quantitative representation may vary from a specified reference without resulting in a change in the basic functionality of the subject matter in question. "Comprises," "includes," and / or each plural are open-ended and include the recited parts and may include additional parts that are not recited. "And / or" is open-ended and includes one or more of the recited parts and combinations of the recited parts.

[0018] To better understand the present disclosure, FIGS. 1A and 1B depict a prior art anchor delivery system 100 for anchoring tissue to bone. As shown in FIG. 1A, anchor delivery system 100 generally includes a threaded anchor sleeve 101 and a hammerable tip 102. In an embodiment, anchor sleeve 101 includes a plurality of turns of helical thread 104 having a plurality of openings 106 between the turns of the plurality of turns of helical thread 104 to allow bone ingrowth from bone into an interior volume defined within the plurality of turns of helical thread 104. In an embodiment, tip 102 includes a suture capture member, such as a plug (not shown), advanceable through an interior cavity of tip 102 to lock one or more sutures within eyelets 102a extending through tip 102. In an embodiment, tip 102 may include barbs 108 protruding from the tip to improve pull-out strength of tip 102. However, in other embodiments, tip 102 may be smooth sided. In embodiments, anchor sleeve 101, tip 102, and plug may be constructed from a polymer (e.g., PEEK), a bioabsorbable material, a metal (e.g., surgical steel, titanium), or any other suitable material.

[0019] As shown in more detail in FIG. 1B, the anchor sleeve 101 and tip 102 may be placed into bone using a delivery device 115. The delivery device 115 generally includes an outer shaft 117 for engaging the anchor sleeve 101, an inner shaft 103 for engaging a plug in the tip 102, and a handle assembly 107 for holding and manipulating the delivery device 115. In embodiments, the delivery device 115 may also include one or more intermediate shafts 105 for providing additional rigidity when driving the tip 102. In embodiments, the interior volume of the anchor sleeve 101 may include longitudinal ribs that engage grooves or slots 108 extending along the outer shaft 117. In other embodiments, the outer shaft 117 may include longitudinal ribs (not shown) that engage recesses extending through the interior volume of the anchor sleeve 101. In some embodiments, the anchor sleeve 101 is screwed or otherwise advanced into the bone by the outer shaft 117 over the proximal end of the tip 102 by rotation of the sleeve advancement member 111. In embodiments, the suture capture knob 109 is operatively coupled to the proximal end of the inner shaft 103 such that rotating or twisting the suture capture knob 109 causes the inner shaft 103 to advance a plug within the eyelet 102a of the tip 102. Additional non-limiting examples of anchor delivery systems can be found in U.S. Patent No. 9,526,488 to Smith & Nephew, Inc. (Memphis, Tenn.), the entire contents of which are incorporated herein by reference.

[0020] 2A, an example of an anchor delivery system 200 of the present disclosure is shown in an exploded perspective view. Anchor delivery system 200 can be used to insert an anchor sleeve 201 and a tip, such as tip 102, into a bone. As shown in FIG. 2A, anchor delivery system 200 includes a delivery device 215 having an outer shaft 217 for engaging anchor sleeve 201. Anchor sleeve 201 comprises a substantially cylindrical sleeve body 210 having a proximal end 210a, a distal end 210b, and a plurality of turns of helical thread 204 extending between proximal end 210a and distal end 210b. In an example, distal end 210b of sleeve body 210 may include an unthreaded portion, as shown. The sleeve body 210 defines an interior volume 212 that communicates with an exterior of the sleeve body 210 through at least one set of axially aligned openings 206 defined by a portion of the sleeve body 210 extending between adjacent turns of the helical thread 204. In an embodiment, four sets of axially aligned openings 206 are defined by the sleeve body 210. However, more or less than four sets of axially aligned openings 206 are contemplated by the present disclosure. Each set of axially aligned openings 206 is spaced about 90° around the circumference of the sleeve body 210 from another set of axially aligned openings 206. The sleeve body 210 also includes at least one slot 216 disposed within the interior volume 212 and extending between the proximal end 210a and the distal end 210b of the sleeve body 210. In an embodiment, the sleeve body 210 includes four slots 216. However, more or less than four slots 216 are contemplated by the present disclosure. Each slot 216 is spaced approximately 90° from another slot 216 around the surface of the interior volume 212 and is disposed between adjacent sets of axially aligned openings 206.

[0021] 2A, the outer shaft 217 of the delivery device 215 includes a proximal portion 217a and a distal portion 217b. The outer surface of the distal portion 217b includes a plurality of ridges 220 extending the length of the distal portion 217b. In an embodiment, the distal portion 217b includes four ridges 220; however, more or less than four ridges 220 are contemplated by the present disclosure. Each ridge 220 is spaced about 90° from another ridge 220 around the outer surface of the outer shaft 217 and is defined by two substantially flat sides 222, 224 extending along the length of the ridge 220. Side 224 includes a first set 214 of axially aligned laser marked numbers and side 222 includes a second set 218 of axially aligned laser marked numbers, the purpose of which will be explained in more detail below. Each ridge 220 is configured to engage with a respective slot 216 of the anchor body 210 when the distal portion 217 b of the delivery device 215 is inserted into the interior volume 212 of the anchor body 210 .

[0022] 2B, a detailed view of the sleeve body 210 and the distal portion 217b of the delivery device 215 is shown in an assembled view. In FIG. 2B, a first set 214 of laser marked numbers, which may be five numbers 214 on the side 224 of the delivery device 215, is visible through a first set of axially aligned openings 206 of the sleeve body 210. The first set 214 of numbers counts down in a stepwise manner by odd numbers (e.g., 9, 7, 5, 3, 1) from the distal end 210b to the proximal end 210a of the sleeve body 210. FIG. 2C shows the sleeve body 210 of FIG. 2B rotated clockwise by about one-eighth of a turn. As seen in FIG. 2C, a second set 218 of laser marked numbers, which may be four numbers on the side 222 of the delivery device 215, is visible through a second set of axially aligned openings 206 of the sleeve body 210. The second set of numbers 218 count down in a stepped manner by even numbers (e.g., 8, 6, 4, 2) from the distal end 210b to the proximal end 210a of the sleeve body 210. In use, as the sleeve body 210 is inserted into the bone by rotation of the outer shaft 217, the first set of numbers 214 and the second set of numbers 218 provide visual feedback to the user that the sleeve body 210 is being inserted into the bone rather than simply spinning freely.

[0023] It will be appreciated that if the sleeve body 210 of FIG. 2C is rotated again clockwise, a third set of laser marked numbers, which may be five numbers on the side opposite side 224 of the delivery device 215, may be visible through the third set of axially aligned openings 206 of the sleeve body 210. The third set of numbers may count down in a stepped manner by odd numbers from the distal end 210b to the proximal end 210a of the sleeve body 210. If the sleeve body 210 of FIG. 2C is further rotated clockwise, a fourth set of laser marked numbers, which may be four numbers on the side opposite side 222 of the delivery device 215, may be visible through the fourth set of axially aligned openings 206 of the sleeve body 210. The fourth set of numbers may count down in a stepped manner by even numbers from the distal end 210b to the proximal end 210a of the sleeve body 210. It is also contemplated by the present disclosure that other visual markings than numbers can be used to indicate the progress of insertion of the anchor body 210 into the bone. For example, the markings may be a sequence of alternating symbols such as dots and dashes. In other examples, the markings may be a sequence of dots that vary in size, number, and / or shape. In further examples, the markings may be a series of dashed lines with varying azimuth angles.

[0024] 3A, an embodiment of a tip 302, an inner shaft 303, a midshaft 305, and a locking plug 313 are illustrated in cross-sectional detail. In an embodiment, the tip 302 includes a distal portion 302c and a proximal portion 302b. A tip cavity 302d is defined in the proximal portion 302b of the tip 302 and is configured to receive a plug 313 through an opening in the proximal portion 302b. An eyelet 302a extends through the distal portion 302c of the tip 302 and communicates with the tip cavity 302d. In an embodiment, the distal end of the tip 302 may be sharpened to create a bone hole, as shown. However, it is contemplated by the present disclosure that the distal end of the tip 302 may be blunt if a bone hole has been created prior to inserting the tip 302. Plug 313 includes an inner cannula 313b extending therethrough, and an outer surface of plug 313 includes threads 313a. In an embodiment, threads 313a extend the entire length of plug 313. In another embodiment, as shown, only a proximal portion of plug 313 is threaded, and a distal portion of plug 313 is unthreaded. Tip cavity 302d includes threads 302e that engage with threads 313a of plug 313 upon insertion of a portion of plug 313 into tip cavity 302d. In an embodiment, the remaining portion of plug 313 extends outside tip cavity 302d.

[0025] 3A, when engaged with a delivery device, the proximal portion 302b of the tip 302 is coupled to the midshaft 305 and the inner shaft 303 extends through the midshaft 305 to engage the inner cannula 313b of the plug 313. In an embodiment, the inner cannula insert 313b of the plug 313 and the mating portion of the inner shaft 303 have a corresponding geometric shape, such as a hexagonal shape. During tissue repair, a suture 319 attached to the soft tissue (not shown) is placed through the eyelet 302a of the tip 302. The length of the inner shaft 303 is selected such that a gap or void 330 (FIG. 3B) is formed between the distal end of the inner shaft 303 and the distal end of the inner cannula 313b of the plug 313. The void 330 may be empty of material or may be filled with a material having a lower density than the plug 313. Thus, the void 330 provides a crushable zone at the distal end of the plug 313, allowing the distal end of the plug 313 to be deformable. In use, the tip 302 is placed into a bone hole (not shown) by axial advancement, such as by malleting, of the delivery device. The suture capture knob 109 of the delivery device 115 (FIG. 1B) is rotated to move the plug 313 distally, via the inner shaft 303, into the eyelet 302a where the plug 313 faces the suture 319. As the plug 313 and inner shaft 303 move further down into the eyelet 302a, the plug 313 impacts the suture 319 with sufficient force to deform the distal end of the plug 313 around the suture 319, thereby allowing more surface contact between the suture 319 and the plug 313. Increased surface contact between plug 313 and suture 319 advantageously allows for more friction and retention force by plug 313 on suture 319 within eyelet 302a.

[0026] 4A, an embodiment of an anchor delivery system 400 of the present disclosure is shown in an exploded perspective view. Anchor delivery system 400 can be used to insert anchor sleeve 401 and tip 402 into bone. As shown in FIG. 4A, anchor delivery system 400 includes an outer shaft 417 for engaging sleeve 401 and a mid-shaft 405 extending through outer shaft 417 for engaging tip 402. A proximal end of outer shaft 417 is coupled to outer shaft hub 423. Outer shaft hub 423 is, in turn, configured to be threadably coupled to central housing 430. Anchor delivery system 400 also includes a drive housing 426 for holding mid-shaft 405. The anchor delivery system 400 further includes a suture capture knob 409 coupled to the inner shaft 403 for advancing the plug 413 in the tip 402, a sleeve advancement member 411 for threading the anchor sleeve 401 into the bone, and a handle grip 425 for holding and / or steering the anchor delivery system 400 during insertion of the anchor sleeve 401 into the bone. A spring 432 is disposed within the drive housing 426 and is configured to permit relative movement between the outer shaft 417 and the inner shaft 403, thereby absorbing at least a portion of the impact forces exerted on the sleeve 401 during driving of the tip structure 402. The anchor delivery system 400 may also include an anti-rotation feature, such as a bridge 434, described in more detail below.

[0027] FIG. 4B shows the internal components of the handle assembly 407 of the delivery device 415 of FIG. 4A in a cross-sectional view. In particular, FIG. 4B shows the sleeve advancing member 411 and the handle grip 425. The proximal end of the sleeve advancing member 411 defines a rotatable knob 411a that extends outside the handle grip 425 near the proximal end of the handle assembly 407. In an embodiment, the proximal portion 430a of the central housing 430 may have internal threads 430c for engaging with threads 423a on the outer surface of the outer shaft hub 423. The distal portion 430b of the central housing 430 may be unthreaded and form a "spin cavity" 436, the purpose of which is described in more detail below. The outer shaft hub 423 may further engage the distal end 411b of the sleeve advancing member 411. Thus, twisting or rotating the sleeve advancement member 411 by the rotatable knob 411a rotates the outer shaft hub 423, thereby causing the outer shaft hub 423 to advance distally along the threads 430c of the central housing 430, which in turn causes the outer shaft 417 to advance the sleeve 401 into engagement with the bone and / or tip 402.

[0028] 4B, the bridge 434 is configured to stabilize the handle grip 425 to the drive housing 426 and prevent the handle grip 425 from rotating during rotation of the sleeve advancing member 411. In their natural states, the bridge 434, drive housing 426, sleeve advancing member 411, and handle grip 425 have an inherent axial clearance that prevents these components from binding during use. Thus, in the handle assembly 407 of the present disclosure, the length of the bridge 434 is selected to place the bridge 434 in compression, like a spring. This compression absorbs the axial clearance between the components when the drive housing 426, sleeve advancing member 411, and handle grip 425 are forced into axial contact. Specifically, the force generated by the bridge 434 placed in compression urges the drive housing 426 and handle grip 425 away from each other. The force generated by the bridge 434 placed in compression is counterbalanced at the flexion joint between the sleeve advancement member 411 and the drive housing 426, and at the flexion joint between the handle grip 425 and the sleeve advancement member 411. The amount of axial force exerted by the bridge 434 is a function of the amount of inherent interference between the bridge 434 and other components, and the stiffness of the bridge 434. Thus, the stiffness of the bridge 434 is selected such that a range of acceptable non-zero axial loads are generated by the handle assembly 407 with the currently defined component tolerances. These generated axial loads advantageously remove axial clearance from the components of the handle assembly 407, thereby eliminating the feeling of looseness in the handle assembly 407 experienced by the user. It is also contemplated by the present disclosure that other compression mechanisms besides the bridge 434 can be used to axially load the handle assembly 407. Additionally, the amount of interference can be set with shims (not shown) for each individual handle assembly 407 to closely tune the compression force and feel for each individual handle assembly 407.

[0029] 4C, in some cases, some useful progression of the outer shaft hub 423 within the central housing 430 is wasted while the anchor sleeve 401 spins on the bone surface without penetrating the bone. This can prevent the anchor sleeve 401 from being fully secured flush or below the cortical bone surface, which is a desired outcome. Thus, in the handle assembly 407 of the present disclosure, upon completion of distal progression of the outer shaft hub 423 within the central housing 430, the outer shaft hub 423 is configured to be fully unthreaded from the threads of the central housing 430 and to rotate freely within the spin cavity 436. If the anchor sleeve 401 is not fully secured flush or below the cortical surface of the bone, the free rotation of the outer shaft hub 423 within the spin cavity 436 may be sufficient to complete insertion of the anchor sleeve 401 into the bone. It is further contemplated that threads may be completely eliminated from both the central housing 430 and the outer shaft hub 423, and that free spinning of the outer shaft hub 423 within the central housing 430 is sufficient to insert the anchor sleeve 401 into the bone.

[0030] 5A, another embodiment of a handle assembly 507 of the present disclosure is shown in a cross-sectional view. In the handle assembly 507, the length L of the thread 530c of the central housing 530 is selected to exceed the graduated distance D between the distal end of the anchor sleeve 501 and the distal portion 502c of the tip 502 (FIG. 5B). The length L of the thread 530c allows the anchor sleeve 501 to undergo more handle-driven advancement, helping to address the problem of the anchor sleeve 501 remaining protruding from the bone or tissue. In use, the user first inserts the tip 502 into the bone hole. The user then actuates a plug (e.g., plugs 313, 413) into the tip 502 before inserting the anchor sleeve 501 to engage the tip 502. Actuating the plug releases the tip 502 from the midshaft 505 of the delivery device 515. If the anchor sleeve 501 is rotated without being inserted into the bone, the mechanical action of the delivery device 515 will remove the midshaft 505 from the bone hole. However, because the tip 502 is free from the midshaft 505, the tip 502 will generally remain in its fully deployed distal position. The user can then rotate the anchor sleeve 501 without it being threaded into the bone over several turns of the sleeve advancement member 511 without fear of losing mechanically assisted axial progression from the delivery device 515. In an embodiment, the threads 530c of the central housing 530 may be longer or shorter, as long as the overall length L of the threads 530c exceeds the distance D between the anchor sleeve 501 and the distal portion 502c of the tip 502.

[0031] 6A, an example of an unlocking tool 600 of the present disclosure for use with anchor delivery system 100, 200, 400 is shown in a side view. Unlocking tool 600 is configured to remove tip 602 from suture 619 after tip 602 is deployed in bone. Unlocking tool 600 has a working length similar to the working lengths of anchor delivery systems 100, 200, 400 described above. As shown in FIG. 6A, unlocking tool 600 comprises handle 625 and shaft 603 extending from handle 625. In an embodiment, handle 625 is made for single use and is constructed from injection molded plastic. In another embodiment, handle 625 is reusable and is constructed from stainless steel. The distal end of shaft 603 comprises a hex feature 660 configured to fit into hex cannula 613b of plug 613 (FIG. 6B). Thus, the unlocking tool 600 is used to loosen the contact between the plug 613 and the suture 619 secured within the tip 602 , thereby allowing removal of the tip 602 from the suture 619 .

[0032] 6C, in use, for example, an instrument such as a grasper tool 662 is introduced into the fractured repair site after the anchor sleeve 601 has been inserted into the bone. The tip 602 is held by the grasper tool 662 to stabilize the tip 602 during removal of the plug 613. The unlocking instrument 600 is then inserted into the proximal end 602b of the tip 602. As shown in FIG. 6D, the hexagonal feature 660 of the unlocking instrument 600 then engages the cannula 613b of the plug 613. After the unlocking instrument 600 engages the plug 613, the unlocking instrument 600 is rotated to loosen the contact between the plug 613 and the suture 619 that has been threaded through the eyelet 602a. Once the plug 613 is loosened, the user can use the grasper tool 662 (or other means) to hold the tip 602, slide it off the suture 619, and retrieve the tip 602 from the repair site. The user is then free to use a replacement anchor sleeve / tip along with the suture 619 to complete the repair. It is contemplated by the present disclosure that the unlocking instrument 600 may also include a mechanism (not shown) for gripping the tip 602 during removal of the plug 613.

[0033] 7A and 7B, an example of a drilling tool 700 of the present disclosure for use with anchor delivery system 100, 200, 400 is shown in a side view (FIG. 7A) and a detailed view (FIG. 7B). As shown in FIGS. 7A and 7B, drilling tool 700 includes a handle grip 725 and a shaft 717 extending from handle grip 725. In an embodiment, shaft 717 includes a distal pointed tip 742 for drilling into bone. Threaded portion 701 of drilling tool 700 may include multiple turns of helical threads 704 for pre-tapping a bone hole prior to inserting a threaded anchor sleeve. Drilling tool 700 also includes a marking element 738 disposed about shaft 717 adjacent proximal end 710a of threaded portion 701. In an embodiment, marking element 738 includes an absorbent material pre-saturated with surgical ink. In an embodiment, marking element 738 has a ring-shaped configuration, as shown. However, the present disclosure contemplates other suitable shapes for marking element 738, including two half-rings. As shown in FIG. 7C, a protective cap 740 covers tip 742 and marking element 738 of bone preparation tool 700 to prevent tip 742 from puncturing the surrounding packaging and to prevent marking element 738 from drying out.

[0034] 7D-7G illustrate an example of using the drilling tool 700 in a surgical repair. As shown in FIG. 7D, the surgeon first inserts the tip 742 of the drilling tool 700 into the bone 744. Next, as shown in FIG. 7E, the surgeon rotates the drilling tool 700 to advance the threaded portion 701 into the bone 744 until the marking element 738 contacts the surface of the bone 744. As the marking element 738 contacts the surface of the bone 744, the marking element 738 marks the bone 744 with ink. As shown in FIG. 7F, the surgeon then unscrews the drilling tool 700 and removes it from the repair site, leaving behind a drilled bone hole 746 and an ink mark 748 identifying the location of the drilled bone hole 746 (FIG. 7G). The present disclosure also contemplates other methods of marking the bone hole 746, including using radio frequency energy.

[0035] Although the present disclosure has been particularly shown and described with reference to preferred embodiments thereof, those skilled in the art will understand that various changes in form and details may be made therein without departing from the spirit and scope of the present application as defined by the appended claims. Such variations are intended to be within the scope of the present application. Thus, the foregoing description of embodiments of the present application is not intended to be limiting, but rather the full scope is to be conveyed by the appended claims. [Additional note 1] 1. An anchor delivery system comprising: a sleeve body having a proximal end, a distal end, and a plurality of turns of a helical thread extending between the proximal end and the distal end, the sleeve body defining an interior volume in communication with an exterior region of 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 the helical thread along a length of the sleeve body; a delivery device comprising an elongate 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 includes a series of axially aligned markings extending along a length of the at least one of the first and second sides; and wherein 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 when the sleeve body is engaged with the distal portion of the shaft, providing visual feedback to a user regarding the progress of insertion of the sleeve body into bone. [Additional note 2] 2. The anchor delivery system of claim 1, wherein the internal volume of the sleeve body includes at least one slot extending between the proximal end and the distal end of the sleeve body, and wherein the at least one ridge of the delivery device is engageable with the at least one slot of the sleeve body when the sleeve body is engaged with the distal portion of the shaft. [Additional note 3] 3. The anchor delivery system of claim 2, wherein the at least one slot is four slots, each slot spaced approximately 90° apart from another slot around the surface of the interior volume of the sleeve body. [Additional note 4] 3. The anchor delivery system of claim 2, wherein 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. [Additional note 5] 2. The anchor delivery system of claim 1, wherein the at least one set of axially aligned openings is a set of four axially aligned openings, each set of axially aligned openings spaced about 90 degrees around the circumference of the sleeve body from another set of axially aligned openings. [Additional note 6] 2. The anchor delivery system of claim 1, wherein the at least one ridge is four ridges, each ridge spaced approximately 90° apart from another ridge around the surface of the shaft of the delivery device. [Additional note 7] 2. The anchor delivery system of claim 1, wherein at least one set of the axially aligned markings includes a set of numbers. [Additional note 8] 8. The anchor delivery system of claim 7, wherein the set of numbers includes five numbers that count down in a stepped manner by odd numbers from the distal end to the proximal end of the shaft. [Additional note 9] 8. The anchor delivery system of claim 7, wherein the set of numbers includes four numbers that count down in a stepped manner by even numbers from the distal end to the proximal end of the shaft. [Additional Note 10] 2. The anchor delivery system of claim 1, wherein at least one set of axially aligned openings includes five axially aligned openings. [Additional Note 11] 2. The anchor delivery system of claim 1, wherein at least one set of axially aligned openings includes four axially aligned openings. [Additional Note 12] 1. An anchor delivery system comprising: a tip having a distal portion and a proximal portion, the proximal portion defining a cavity therein with a wall of the cavity having a thread and an eyelet defined in the distal portion of the tip communicating with the cavity; a plug having a threaded outer portion and an inner cannula configured to receive 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 engage the threads of the cavity and the plug is rotatably and axially movable through the cavity by rotation of the inner shaft such that the plug engages a suture threaded through the eyelet; An anchor delivery system, wherein a length of the inner shaft of the delivery device is selected such that when the inner shaft is disposed within the cannula of the plug, a gap is formed between the distal end of the inner shaft and the distal end of the cannula, the gap providing a collapsible zone such that the distal end of the plug is deformable when the plug is engaged with the suture in the eyelet. [Additional Note 13] 13. The anchor delivery system of claim 12, wherein a proximal portion of the plug extends from the cavity of the tip. [Additional Note 14] 13. The anchor delivery system of claim 12, wherein the tip is coupled to an intermediate shaft of the delivery device such that the inner shaft extends through the intermediate shaft. [Additional Note 15] 13. The anchor delivery system of claim 12, wherein the plug further comprises an unthreaded outer portion, the unthreaded outer portion distal to the threaded outer portion.

Claims

1. 1. An anchor delivery system comprising: an anchor sleeve comprising a sleeve body having a proximal end and a distal end and provided with a plurality of turns of a helical thread extending between the proximal end and the distal end, the sleeve body defining an interior volume in communication with an exterior region of 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 the helical thread along a length of the sleeve body; a delivery device comprising an elongate 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 includes a series of axially aligned markings extending along a length of the at least one of the first and second sides; 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 when the sleeve body is engaged with the distal portion of the shaft to provide visual feedback to a user regarding the insertion progress of the sleeve body into bone; An anchor delivery system, wherein the series of axially aligned markings are located inward from an outer surface of the sleeve body.

2. 2. The anchor delivery system of claim 1, wherein the interior volume of the sleeve body includes at least one slot extending between the proximal and distal ends of the sleeve body, and wherein the at least one ridge of the delivery device is engageable with the at least one slot of the sleeve body when the sleeve body is engaged with the distal portion of the shaft.

3. The anchor delivery system of claim 2 , wherein the at least one slot is four slots, each slot spaced approximately 90° apart from another slot around a surface of the interior volume of the sleeve body.

4. 3. The anchor delivery system of claim 2, wherein 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.

5. 2. The anchor delivery system of claim 1, wherein the at least one set of axially aligned openings is a set of four axially aligned openings, each set of axially aligned openings spaced approximately 90 degrees around the circumference of the sleeve body from another set of axially aligned openings.

6. 2. The anchor delivery system of claim 1, wherein the at least one ridge is four ridges, each ridge spaced approximately 90 degrees from another ridge around a surface of the shaft of the delivery device.

7. The anchor delivery system of claim 1 , wherein at least one set of axially aligned markings comprises a set of numbers.

8. 8. The anchor delivery system of claim 7, wherein the set of numbers includes five numbers that count down in a stepped manner by odd numbers from the distal end to the proximal end of the shaft.

9. 8. The anchor delivery system of claim 7, wherein the set of numbers includes four numbers that count down in a stepped manner by even numbers from the distal end to the proximal end of the shaft.

10. The anchor delivery system of claim 1 , wherein the at least one set of axially aligned openings includes five axially aligned openings.

11. The anchor delivery system of claim 1 , wherein the at least one set of axially aligned openings includes four axially aligned openings.

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