Multi-barrel drill guide and anchor deployment assembly

Abstract

To provide an assembly requiring minimal movement and surgical time for drilling a pilot hole, and an assembly for inserting and deploying a suture anchor with reliable retention capacity.SOLUTION: A multi-barrel drill guide and anchor deployment assembly 100 comprises an elongated body 102 extending along a longitudinal axis having a proximal end 104 and a distal end 106, an elongated distal guide tube 128 attached to and extending from the distal end, a handle 108 extending from the elongated body between the proximal and distal ends, and a sliding inserter 118 movably connected to the elongated body and configured to move between the proximal and distal ends of the elongated body.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 515033, filed June 5, 2017, U.S. Provisional Patent Application No. 62 / 515082, filed June 5, 2017, U.S. Provisional Patent Application No. 62 / 516733, filed June 8, 2017, U.S. Provisional Patent Application No. 62 / 618817, filed January 18, 2018, and U.S. Provisional Patent Application No. 62 / 649181, filed March 28, 2018.

[0002] 1. Technical Field The present invention relates to drills, anchor drivers, and drill guides for drilling pilot holes at a surgical repair site and inserting suture anchors into the pilot holes, and more particularly to a multi-barrel drill guide and anchor placement assembly for drilling pilot holes at a surgical repair site and inserting suture anchors into the pilot holes while maintaining alignment between the drill guide and the pilot holes. [Background technology]

[0003] 2. 2. Description of Related Art Many orthopedic and medical procedures require the fixation of one body part to another. Such body parts may include bones, soft tissues, and prosthetic limbs. One body part can be fixed in position relative to another body part using connector devices, such as screws and suture anchors (e.g., cannulated knotless suture anchors and soft all-suture anchors). For example, various orthopedic surgical procedures require the insertion of a suture anchor into bone and its fixation. In such procedures, a pilot hole is drilled into the bone before inserting the suture anchor. Traditionally, a standard single-barrel drill guide is placed at the desired pilot hole location on the bone, and a drill is placed through the drill guide to create the pilot hole. The drill is then removed and replaced with a driver preloaded with a suture anchor. Thus, the surgeon must maintain the alignment of the drill guide with the pilot hole while also completely removing the drill from the drill guide and inserting the driver. Changing tools in the drill guide after creating the pilot hole increases the risk of losing the alignment of the drill guide with the pilot hole. Loss of alignment can require additional surgical time to correct the misalignment, if at all possible, and can cause trauma to the tissue or bone surrounding the pilot hole. Loss of alignment can also result in bending of the anchor inserter rod or an anchor not being fully inserted into the pilot hole, which can add cost and surgical time. To avoid misalignment with a standard single-barrel guide, an assistant may be required to help maintain alignment or attempt realignment.

[0004] Furthermore, conventional suture anchors placed with conventional drivers are often too large for procedures involving soft tissue fixation at the distal end. The bone hole drilled at the distal end must be shallow and have a narrow diameter due to the very nature of the surgical site. Shallow bone holes require the anchor to have excellent retention capabilities, as a secured anchor may completely release from the bone hole as it moves away from the shallow bone hole. At the very least, the anchor may extend beyond the shallow, narrow bone hole. An improperly fitted suture anchor can increase instability and cause inflammation or damage to the tissue surrounding the exposed portion of the anchor.

[0005] Attempts to address the problem include reducing the size of conventional suture anchors to fit into shallow, narrow bone holes. However, as the size of conventional suture anchors is reduced, If the anchor is displaced, it will lose its holding ability and will therefore be unstable within the bone hole. While many factors can affect the holding ability of a suture anchor, such as the type of tissue, the size of the bone hole, and the design of the anchor, the method of placement of the suture anchor can also affect the holding ability of the suture anchor.

[0006] Therefore, there is a need for an assembly that requires minimal travel and surgical time to drill a pilot hole, and an assembly for inserting and deploying a suture anchor that has reliable retention capabilities.

[0007] Related Art Section Disclaimer Explanation: To the extent that specific patents / publications / products are discussed in this Related Art Section description or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for purposes of patent law. For example, some or all of the patents / publications / products discussed may not be sufficiently early in time, may not reflect subject matter that developed early enough in time, and / or may not be sufficiently valid to be prior art for purposes of patent law. To the extent that a specific patent / publication / product is discussed above in this Related Art Section description and / or throughout the application, that description / disclosure is incorporated herein by reference in its entirety. Summary of the Invention

[0008] Embodiments of the present invention recognize that there are potential problems and / or drawbacks with conventional single-barrel drill guides (discussed herein above). For example, removing a drill bit from a drill guide and replacing it with a driver to insert a suture anchor increases the risk of misalignment of the pilot hole with the drill guide, which requires additional surgical time and poses a risk of trauma to the surrounding tissue and bone. Therefore, there is a need for a multi-barrel drill guide and anchor placement assembly configured to simultaneously accommodate both a drill bit and a driver with a suture anchor. Such a structural configuration allows the suture anchor to be in place with the anchor driver in separate but converging pathways / channels within the drill guide, ready for insertion into the pilot hole immediately after the pilot hole is formed by the drill bit. This can be done without having to withdraw the drill bit from the drill guide before the suture anchor driver can be inserted into the post-convergence region of the drill guide. 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 drawbacks described herein.

[0009] The present disclosure is directed to the inventive design, structure, and resulting function of a multi-barrel drill guide and anchor placement assembly. The multi-barrel drill guide and anchor placement assembly includes an elongate body extending along a longitudinal axis having a proximal end and a distal end, with a handle extending from the elongate body at an angle (either acute or perpendicular from the longitudinal axis) from the longitudinal axis at a location between the proximal and distal ends. The assembly also includes an elongate distal guide tube attached to and extending from the distal end of the elongate body. A sliding inserter is movably connected to the elongate body such that the sliding inserter is configured to move between the proximal and distal ends of the elongate body. The assembly has a first channel extending from the proximal end to the distal end and a second channel extending from the distal end along the elongate body to a location between the distal and proximal ends. The second channel extends at an angle relative to the first channel. The first and second channels intersect at a convergent region at the distal end. In one embodiment, the convergent region extends to a single exit point. In another embodiment, the single exit point is at the distal end of the elongate distal guide tube.

[0010] The multi-barrel drill guide and anchor placement assembly slides within the first channel The second channel is configured to accommodate a movable suture anchor and driver, and is connected to the movable sliding inserter and drill bit in a slidable manner within the second channel. In one embodiment, the second channel forms a curve away from the handle. In another embodiment, a portion (or bent portion) of the second channel extends at a different angle relative to the longitudinal axis than the remainder of the second channel. According to one embodiment, the elongate body has an optional slot / slit for a filament (or suture) connected to the anchor positioned through the outer surface of the elongate body (and preferably the first channel). In another embodiment, the assembly includes a locking mechanism configured to selectively lock the sliding inserter in place relative to the elongate body. In one embodiment, the locking mechanism includes an opening in the sliding inserter selectively aligned with an opening in the elongate body extending into the second channel. In the locked position, the drill bit extends through the opening in the sliding inserter and the opening in the elongate body into the second channel.

[0011] In another embodiment of the assembly, the elongate body includes a recess and a shallow placement button hinged within the recess. In one embodiment, a driver is connected to the sliding inserter, and sliding the driver distally along the first channel rotates the shallow placement button out of the recess.

[0012] According to another aspect, a method of drilling pilot holes and inserting suture anchors into the pilot holes includes: (i) providing a multi-barrel drill guide and anchor placement assembly having an elongate body extending along a longitudinal axis having a proximal end and a distal end, wherein the handle extends at an angle from the longitudinal axis (at an acute angle or a perpendicular angle from the longitudinal axis) at a location between the proximal end and the distal end, an elongate distal guide tube attached to the distal end of the elongate body and extending distally, a sliding inserter movably connected to the elongate body such that the sliding inserter is configured to move between the proximal and distal ends of the elongate body, a first channel extending from the proximal end to the distal end, a second channel extending from the distal end to a location between the distal and proximal ends of the elongate body, the second channel extending at an angle relative to the first channel; (viii) extending the anchor driver through the first channel and the second channel; (ix) implanting the suture anchor into the pilot hole. The method may be performed using a driver having a drill bit positioned in the first channel and a suture anchor positioned in the second channel.

[0013] Suture material or suture, as that term is used and described herein, includes monofilament or multifilament sutures and any other metallic or non-metallic filament or wire-like material suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials.

[0014] Suture anchor, as used herein, can include soft suture anchors and hard suture anchors. Soft suture anchors are formed from filaments of suture material that are retained within a pre-formed bone hole by deforming so that their diameter is larger than the size of the hole, thereby residing within the cancellous bone and subcortically. One such suture anchor is disclosed in U.S. Patent No. 9,826,971, assigned to the assignee of the present application and incorporated herein by reference. The entire contents of which are incorporated herein by reference. Because soft anchors are typically made entirely of suture material, they are sometimes referred to as "all-suture" anchors and generally include a fixation body portion of a fibrous construct (or, as described in U.S. Pat. No. 9,173,652, a fibrous, braided, or woven-type structure, such as a flexible web) and a suture or filament portion. Methods and devices for inserting / deploying such all-suture anchors are known, examples of which are disclosed in U.S. Pat. No. 9,173,652. As described in U.S. Pat. No. 8,409,252, for example, a "non-soft," "hard," or "rigid" suture anchor generally includes a "hard" anchor body portion (which may or may not include an inner member and an outer member) and a suture / filament portion.

[0015] The fixation bodies of such suture anchors can be formed of biocompatible and / or bioabsorbable materials. These materials can be of such compositions that are resorbed by the body, for example, during the bone healing process. Exemplary materials 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"), and other metallic, non-metallic, and polymeric materials. [Brief explanation of the drawings]

[0016] The present invention will be more fully understood and appreciated from the following detailed description read in conjunction with the accompanying drawings, which illustrate only typical embodiments of the disclosed subject matter and are not intended to limit the scope of the disclosed subject matter, to which other equally effective embodiments may be permissible. Reference will now be made briefly to the accompanying drawings, in which:

[0017] [Figure 1] FIG. 1 is a first side schematic view of a multi-barrel drill guide and anchor placement assembly in a pre-drilled, pre-anchor deployed, pre-actuated configuration, according to an embodiment. [Figure 2] FIG. 2 is a first side schematic view of a multi-barrel drill guide and anchor placement assembly in a drilled, pre-anchor deployed, pre-actuated configuration, according to an embodiment. [Figure 3] 3 is a first side schematic view of a cross section of the multi-barrel drill guide and anchor placement assembly of FIG. 2, in accordance with an embodiment. [Figure 4] 4 is a first side schematic view of an enlarged cross section of a locking mechanism of the multi-barrel drill guide and anchor placement assembly of FIG. 2, in accordance with an embodiment. [Figure 5] 5 is a cross-sectional front / perspective schematic view of a locking mechanism of the multi-barrel drill guide and anchor placement assembly of FIG. 2, in accordance with an embodiment. [Figure 6]6 is a second side schematic view of an enlarged view of a notch of a locking mechanism of the multi-barrel drill guide and anchor placement assembly of FIG. 2, in accordance with an embodiment. [Figure 7] FIG. 7 is a first side schematic view of a multi-barrel drill guide and anchor placement assembly in a post-drilling, pre-anchor-deployed, pre-actuated configuration, in accordance with an embodiment. [Figure 8] 8 is a first side schematic view of an enlarged cross section of a second channel of the multi-barrel drill guide and anchor placement assembly of FIG. 7, according to an embodiment. [Figure 9] FIG. 9 is a first schematic side view of an enlarged view of a shallow deployment button of a multi-barrel drill guide and anchor deployment assembly in a pre-activated / undeployed configuration, according to an embodiment. [Figure 10] 10 is a second side schematic view of an enlarged cross section of a shallow placement button of the multi-barrel drill guide and anchor placement assembly of FIG. 9, in accordance with an embodiment. [Figure 11] FIG. 11 is a first side schematic view of an enlarged view of a shallow deployment button of a multi-barrel drill guide and anchor deployment assembly in an activated / undeployed configuration, according to an embodiment. [Figure 12] 12 is a schematic, enlarged rear / perspective view of the shallow placement button of FIG. 11, according to an embodiment. [Figure 13] 13 is a schematic rear view of the shallow placement button of FIG. 11, according to an embodiment. [Figure 14] FIG. 14 is a first side schematic view of an anchor driver of a multi-barrel drill guide and anchor placement assembly in an activated / undeployed configuration, according to an embodiment. [Figure 15] 15 is an enlarged schematic view of the sliding inserter and proximal end of the elongate body of FIG. 14, according to an embodiment. [Figure 16] 16 is a first schematic side view of an enlarged view of the sliding inserter and proximal end of the elongate body of FIG. 14, according to an embodiment. [Figure 17]FIG. 17 is an enlarged first side schematic view of a suture anchor in an undeployed state on an anchor driver of a multi-barrel drill guide and anchor placement assembly, according to an embodiment. [Figure 18] FIG. 18 is a first side schematic view of a shallow deployment button of a multi-barrel drill guide and anchor deployment assembly in an activated or deployed configuration, in accordance with an embodiment. [Figure 19] 19 is an enlarged side / perspective schematic view of the shallow placement button of FIG. 18, according to an embodiment. [Figure 20] FIG. 20 is an enlarged first side schematic view of a suture anchor in a deployed state on an anchor driver of a multi-barrel drill guide and anchor deployment assembly, according to an embodiment. [Figure 21] 21 is an enlarged, side schematic view of the suture anchor of FIG. 20 with a multi-barrel drill guide and anchor placement assembly removed, according to an embodiment. [Figure 22] FIG. 22 is a side schematic view of an embodiment of a suture anchor in an undeployed configuration, according to an embodiment. [Figure 23] 23 is a side schematic view of the suture anchor of FIG. 22 loaded into an anchor drive, according to an embodiment. [Figure 24] 24 is a side schematic view of the suture anchor of FIG. 22 loaded onto an anchor driver and positioned within a pilot hole, according to an embodiment. [Figure 25] 25 is a side schematic view of the suture anchor of FIG. 22 between an undeployed and deployed configuration, according to an embodiment. [Figure 26] 26 is another side schematic view of the suture anchor of FIG. 22 between an undeployed and deployed configuration, according to an embodiment. [Figure 27] 27 is a final schematic side view of the suture anchor of FIG. 22 between an undeployed and deployed configuration, according to an embodiment. [Figure 28] 28 is a side schematic view of the suture anchor of FIG. 22 in a deployed configuration, according to an embodiment. [Figure 29] 29 is a side schematic view of the suture anchor of FIG. 22 in a fully deployed configuration, according to an embodiment. [Figure 29A] FIG. 29A is a side schematic view of a suture anchor loaded onto an anchor driver according to an alternative embodiment. [Figure 29B] FIG. 29B is a side schematic view of the suture anchor of FIG. 29A loaded onto an anchor driver in a partially deployed configuration, according to an alternative embodiment. [Figure 29C] FIG. 29C is a side schematic view of the suture anchor of FIG. 29A loaded onto an anchor driver in a fully deployed configuration, according to an alternative embodiment. [Figure 30] FIG. 30 is a first side schematic view of an alternative embodiment of a multi-barrel drill guide and anchor placement assembly in a pre-drilled, pre-anchor placement, pre-actuated configuration, in accordance with an embodiment. [Figure 31] 31 is a first side schematic view of the multi-barrel drill guide and anchor placement assembly of FIG. 30 in a pre-drilled, pre-anchor-placed, pre-actuated configuration, according to an embodiment. [Figure 32] 32 is a first side schematic view of the multi-barrel drill guide and anchor placement assembly of FIG. 30 in a post-drilling, pre-anchor-deployed, pre-actuated configuration, in accordance with an embodiment. [Figure 33] 33 is a first side schematic view of the multi-barrel drill guide and anchor placement assembly of FIG. 30 in a post-drilling, activated / deployed configuration with a suture anchor in a deployed state, in accordance with an embodiment. [Figure 34] 34 is a first side schematic view of the suture anchor of FIG. 33 in a deployed state, according to an embodiment. [Figure 35] FIG. 35 is a side schematic view of an additional embodiment of a suture anchor in an undeployed state, according to an embodiment. [Figure 36]36 is a side schematic view of the suture anchor of FIG. 35 in a deployed state, shortened and expanded, according to an embodiment. [Figure 37] FIG. 37 is a side schematic view of a disposable drill with a pre-installed drill bit, according to an alternative embodiment. [Figure 38] FIG. 38 is a schematic illustration of an all-suture soft tissue fixation device, according to one embodiment. [Figure 39] FIG. 39 is a side schematic view of an anchor driver according to an alternative embodiment. [Figure 40] 40 is a side schematic view of a portion of the anchor driver of FIG. 39. FIG. [Figure 41] 41 is a perspective schematic view of a spool portion of the anchor driver of FIG. 39. FIG. [Figure 42] 42 is a perspective schematic view of the safety bar portion of the anchor driver of FIG. 39. FIG. [Figure 43] 43 is a side perspective schematic view of a portion of the anchor driver of FIG. 39. FIG. [Figure 44] 44 is a top schematic view of a portion of the anchor driver of FIG. [Figure 45] 45 is a side perspective schematic view of a portion of the anchor driver of FIG. 39. FIG. [Figure 46] 46 is a side perspective schematic view of a portion of the anchor driver of FIG. 39. FIG. [Figure 47] 47 is a side perspective schematic view of the fully assembled anchor driver of FIG. 39. [Figure 48] 48 is a side perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 49] 49 is a side schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 50] 50 is a side perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 51] 51 is a side schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 52]52 is a side perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 53] 53 is a side perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 54] 54 is a top perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 55] 55 is a side perspective schematic view of a portion of the anchor driver of FIG. 47. FIG. [Figure 56] FIG. 56 is a perspective schematic view of the anchor in a fully deployed configuration / position / condition. [Figure 57] FIG. 57 is a side schematic view of an anchor driver according to an alternative embodiment. [Figure 58] 58 is a side schematic view of the fully assembled anchor driver of FIG. 57. [Figure 59] 59 is a side perspective schematic view of the anchor driver of FIG. 57. FIG. [Figure 60] 60 is a side perspective schematic view of the anchor driver of FIG. 57. FIG. [Figure 61] 61 is a side perspective schematic view of a portion of the anchor driver of FIG. 57. FIG. [Figure 62] FIG. 62 is a perspective schematic view of the anchor in a fully deployed configuration / position / condition. DETAILED DESCRIPTION OF THE INVENTION

[0018] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, FIG. 1 illustrates a schematic diagram of a fully assembled first side 103 of a multi-barrel drill guide and anchor placement assembly 100 in a pre-drilled, pre-anchor placement, pre-actuated configuration, according to an embodiment. In the illustrated embodiment, the assembly 100 includes, but is not limited to, a distal elongate body 102 extending along a central longitudinal axis x-axis having a proximal end 104 and a distal end 106, a handle 108 (which may include gripping features 109) extending from the elongate body 102 between the proximal and distal ends 104 and 106, a distal tube or guide tip 128 (which may include gripping protrusions or teeth to aid in setting and maintaining bone position) extending from the distal end 106, and a proximal sliding inserter / anchor driver 118 / 114. The elongate body 102 has a substantially sealed exterior (as described above and shown in the figures). The exterior portion of elongate body 102 preferably does not include any moving parts that would complicate or hinder easy use of assembly 100 .

[0019] 1, the handle 108 extends generally perpendicularly from the elongate body 102 between the proximal end 104 and the distal end 106 to increase balance and control of the assembly 100. However, the handle 108 may extend from any position along the elongate body 102 at various angles relative to the central longitudinal axis xx to provide stability when a user grasps the handle 108 to place the assembly 100 at a desired pilot hole location on the bone.

[0020] 1 , the elongate body 102 includes a slot 120 that extends proximally along an axis parallel to the central longitudinal axis xx from the distal end 106, through at least a distal portion of the elongate body 102, through a first opening 107 (formed in the top of the handle 108 and / or the elongate body 102), and to a second, larger opening 111 (formed in the top of the handle 108 and / or the elongate body 102) that extends to the proximal end 104. The slot 120 and openings 107, 111 can extend along an axis perpendicular to the central longitudinal axis xx and through the elongate body 102 to a first channel 110 (see FIG. 5 ) into the second side 105 of the assembly 100.

[0021] As shown in FIG. 1 , the track 113, which includes a first portion 113A positioned along the inside of the second side surface 105 and a second portion 113B positioned along the inside of the bottom of the elongate body 102, extends distally from the proximal end 104 along an axis parallel to the central longitudinal axis xx toward the distal end 106, terminating at or before the distal end 106. The track 113 facilitates movement of the proximal sliding inserter 118 from the proximal end 104 through at least a distal portion of the elongate body 102 (as described in detail below) along the axis parallel to the central longitudinal axis xx.

[0022] The sliding inserter 118 includes an anchor driver 114 attached thereto (shown in FIGS. 5 and 10 ). In a pre-actuated / non-deployed configuration, the anchor driver 114 of the sliding inserter 118 extends from the proximal end 104 of the elongate body 102 through at least a distal portion of the elongate body 102. However, in its pre-actuated / non-deployed configuration, the anchor driver 114 does not extend into the distal tube or guide tip 128 (shown in FIG. 8 ). When fully assembled, the multi-barrel drill guide and anchor placement assembly 100 includes a suture anchor 10 having a passing filament 11 loaded onto the anchor driver 114 (described in detail). When fully assembled, the suture anchor 10 is loaded onto the distal end 115 of the anchor driver 114, while the passing filament 11 extends along the length of the anchor driver 114 and is wrapped or otherwise secured by a loading mechanism 117 at the proximal end 119 of the sliding inserter 118 (also shown in FIGS. 5 and 12 ). The proximal end may also include a mallet section or region on the rear surface of the proximal end. This mallet section can provide the user with a surface against the mallet to assist in setting and maintaining the distal end of the guide tube 128 in the bone prior to drilling a hole. In the illustrated embodiment, the loading mechanism 117 includes one or more notches 121 and a flexible substrate 122. In one embodiment, the flexible substrate 122 is constructed of a foam material, although any other semi-flexible material may be used. The flexibility of the flexible substrate 122 is such that it can be easily removed from the sliding inserter 118 to release the passing filament 11 (which may or may not be attached to a needle, as should be understood by those skilled in the art in conjunction with a review of this disclosure). As shown, the flexible substrate 122 is sized or dimensioned to fit within a portion of the proximal end 119 of the sliding inserter 118.In the illustrated embodiment, the passing filament 11 is removably secured by one or more notches 121 and flexible substrate 122 to permit release of the suture anchor 10 from the assembly 100 when the suture anchor 10 is in a deployed position within the pilot hole.

[0023] 1 , the sliding inserter 118 also includes an opening 123 configured to receive the drill bit 116. In the illustrated embodiment, the opening 123 is located or otherwise positioned at a distal end 124 of the sliding inserter 118. In the pre-drill configuration ( FIG. 1 ) and the drill configuration ( FIGS. 2-3 ), the opening 123 on the sliding inserter 118 aligns with an opening 125 on the elongate body 102. The opening 125 is located or otherwise disposed between the proximal end 104 and the distal end 106 of the elongate body 102 and connects to the second channel 112 in the elongate body 102. Thus, in the pre-drill configuration shown in FIG. 1 , the drill bit 116 extends through the opening 123 in the sliding inserter 118 and into the opening 125 in the elongate body 102. In the drill configuration (shown in FIGS. 2-3 and described in detail below), the drill bit 116 advances through the second channel 112 of the elongate body 102 and through the connected distal tube or guide tip 128. In comparison, in FIG. 1 , the assembly 100 is in the pre-drill configuration, with the drill bit 116 extending only partially through the second channel 112 and not through the distal tube or guide tip 128.

[0024] 2 , a schematic diagram of a fully assembled first side 103 of a multi-barrel drill guide and anchor placement assembly 100 in a drilled, pre-anchor-deployed, pre-actuated configuration is shown, according to an embodiment. In the illustrated embodiment, the drill bit 116 is in the drill configuration such that the drill bit 116 extends through the second channel 112 at a length corresponding to the desired or appropriate depth of the pilot hole. In the illustrated embodiment, the drill bit 116 includes a depth stop 126 at its proximal end 127 that abuts the opening 123 of the sliding inserter 118 when the drill bit 116 reaches the appropriate depth within the pilot hole. The depth stop 126 prevents the drill bit 116 from reaching the appropriate depth within the pilot hole in a particular procedure. The depth stop 126 prevents the drill bit 116 from extending deeper into the bone than is appropriate for the drill bit 116. Similarly, the depth stop 126 also allows the user to determine whether the drill bit 116 has advanced sufficiently into the bone. As shown in FIG. 2, in the drill configuration, the distal end 129 of the drill bit 116 extends out from the distal tube or guide tip 128 to drill a pilot hole.

[0025] Referring now to FIG. 3 , a schematic view of a first side 103 of a cross section of the multi-barrel drill guide and anchor placement assembly 100 of FIG. 2 is shown. Moreover, in the illustrated embodiment, the elongate body 102 includes a first channel 110 and a second channel 112 for receiving tools for drilling pilot holes and inserting the suture anchors 10. As shown in FIG. 3 , the first channel 110 extends from the proximal end 104 to the distal end 106 of the elongate body 102, while the second channel 112 extends from an opening 125 on the elongate body 102 to the distal end 106. Thus, in the illustrated embodiment, the first channel 110 and the second channel 112 have different entry points along the elongate body 102. The two separate entry points accommodate two tools: a drill bit 116 for drilling pilot holes and an anchor driver 114 for inserting the suture anchors 10 into the drilled pilot holes.

[0026] As described above, the first channel 110 extends distally in a generally straight line from the proximal end 104 to the distal end 106 along an axis parallel to the central longitudinal axis xx of the elongate body 102. The second channel 112 extends at an angle relative to the first channel 110 and at an angle relative to the central longitudinal axis xx, which allows the first channel 110 and the second channel 112 to have separate entry points and a single convergence region 130. Thus, although the first channel 110 and the second channel 112 extend from different entry points along the elongate body 102, the first channel 110 and the second channel 112 share a convergence region 130 proximal to a single exit point on the distal end 106 of the elongate body 102. In other words, the convergence region 130 is the region where the channels 110, 112 converge prior to (i.e., proximal to) the single exit point. In the illustrated embodiment, the single exit point is at the distal end 131 of the distal tube or guide tip 128 .

[0027] Thus, the first channel 110 is separate and distinct from the second channel 112 between the entry point and the convergence region 130. Thus, a user can employ the drill bit 116 in the second channel 112 while the anchor driver 114 is seated (positioned and not moved) within the first channel 110 by extending the drill bit 116 into the convergence region 130 and from the distal tube or guide tip 128. As shown in FIG. 3 , the drill bit 116 is in a drill configuration with a distal end 129 of the drill bit 116 extending from the distal tube or guide tip 128 and a depth stop 126 adjacent to the opening 123 on the sliding inserter 118.

[0028] 3 , as described above, the second channel 112 extends at an angle relative to the central longitudinal axis xx of the elongate body 102 and extends proximally away from the first channel 110. In the illustrated embodiment, the second channel 112 includes a bend 132 that curves away from the first channel 110. The second channel 112 may include the bend 132 at any point along its length between the converging region 130 and the opening 125 on the elongate body 102. This bend 132 is configured to position / guide the semi-flexible drill bit 116, which straightens from the distal tube or guide tip 128, through the angled second channel 112. In other words, the bend 132 bends the semi-flexible drill bit 116 such that the drill bit 116 is at an angle that allows it to exit the distal tube or guide tip 128 aligned with the first channel 110 (parallel to the central longitudinal axis xx). As shown in FIG. 3, the drill bit 116 The proximal end 127 is at an angle relative to the distal end 129 of the drill bit 116 .

[0029] As shown in FIG. 3 , the first channel 110 is substantially straight along the bottom of the elongate body 102. When the drill bit 116 is in the drill configuration, the drill bit 116 extends out from the distal tube or guide tip 128 through a convergence region 130. In the pre-drill configuration (shown in FIG. 1 ) and the drill configuration, the anchor driver 114 and suture anchor 10 are proximal to the convergence region 130 of the first channel 110. When there is no obstruction by the anchor driver 114 (and suture anchor 10) in the convergence region 130, the drill bit 116 passes freely through the convergence region 130, via the second channel 112, and out of the distal tube and guide tip 128. However, the first channel 110 is aligned with the convergence region 130 and the distal tube and guide tip 128 such that the anchor driver 114 can easily extend through the convergence region 130 and the distal tube and guide tip 128 without moving the assembly 100 (after the drill bit 116 is removed). In other words, without adjusting the distal end 131 of the distal tube and guide tip 128 to sufficiently align the pilot hole for placement of the suture anchor 10, the suture anchor 10 is less likely to miss a previously drilled hole and more likely to be inserted into the pilot hole. Thus, if the position of the assembly 100 is maintained relative to the bone after the pilot hole is drilled, the suture anchor 10 with the passing filament 11 should be easily delivered into a previously formed pilot hole without having to move or change the angle of the distal tube and guide tip 128 to position the pilot hole.

[0030] 4, a schematic diagram of an enlarged cross-sectional first side 103 of the locking mechanism 133 of the multi-barrel drill guide and anchor placement assembly 100 of FIG. 2 is shown. In the illustrated embodiment, the locking mechanism 133 includes a drill bit 116, an opening 123 on the sliding inserter 118, and an opening 125 on the elongate body 102. The drill bit 116 functions as the locking mechanism 133 when it extends through both openings 123, 125 such that the distal end 129 of the drill bit 116 passes through at least a portion of the second channel 112 (and the elongate body 102) and the proximal end 127 of the drill bit 116 remains outside or external to the elongate body 102. The drill bit 116 maintains the openings 123, 125 in alignment, thereby preventing the sliding inserter 118 from advancing distally along the track 113. Thus, the user can manipulate the drill bit 116 to drill the pilot hole without risk of unintentional movement of the anchor driver 114 (and suture anchor 10).

[0031] 5-6, views of the first side 103 and second side 105 of an exemplary embodiment of the locking mechanism 133 are shown. First, FIG. 5 shows a cross-sectional front / perspective view of the locking mechanism 133 on the first side 103 of the assembly 100. In the illustrated embodiment, movement of the sliding inserter 118 along the track 113 between the first side 103 and the second side 105 of the assembly 100 is blocked or otherwise prohibited when the drill bit 116 extends through the opening 123 in the sliding inserter 118 and the opening 125 in the elongated body 102. Thus, movement of the sliding inserter 118 parallel to the central longitudinal axis xx is contained by the track 113 and is permitted or blocked, respectively, by the absence or presence of the drill bit 116.

[0032] 6 next shows an enlarged view of the second side 105 of the notch 134 of the locking mechanism 133 on the assembly 100 according to an additional embodiment of the locking mechanism 133. In the illustrated embodiment, the locking mechanism 133 further includes a notch 134 on the second side 105 of the assembly 100. As shown, the notch 134 extends outward from the elongated body 102. The notch 134 is configured to engage with an opening 135 in the sliding inserter 118. As shown, In the illustrated embodiment, the notches 134 and corresponding openings 135 are rectangular, although any other compatible configuration of the notches 134 and openings 135 may be used.

[0033] With further reference to FIG. 6 , in the pre-drill configuration ( FIG. 1 ) and the drill configuration ( FIGS. 2-3 ), the aperture 135 engages the notch 134. In particular, the aperture 135 surrounds the notch 134. Once the drill bit 116 is removed from the assembly 100, the user advances the sliding inserter 118 or otherwise applies a force distally to the proximal end 119 of the sliding inserter 118. Such force causes the aperture 135 of the sliding inserter 118 to slide past the notch 134 on the elongate body 102. The sliding inserter 118 can then continue to advance within the track 113, placing the suture anchor 10 into the pilot hole. To reset assembly 100 (i.e., reload assembly 100 with a new suture anchor), the user moves sliding inserter 118 proximally along track 113 until aperture 135 in sliding inserter 118 engages or otherwise locks over notch 134 on elongate body 102. When notch 134 aligns with aperture 135, aperture 123 in sliding inserter 118 aligns with aperture 125 in elongate body 102. Once assembly 100 is reset and aperture 135 is locked over notch 134, sliding inserter 118 cannot move further proximally.

[0034] Referring now to FIG. 7, a schematic diagram of a first side 103 of a multi-barrel drill guide and anchor placement assembly 100 in a post-drilling, pre-anchor-deployed, pre-actuated configuration is shown, according to an embodiment. In the pre-drill and drill configuration shown in FIGS. 1-3 , a suture anchor 10 is pre-loaded onto the distal end 115 of an anchor driver 114 of a sliding inserter 118. In such a configuration, the distal end 115 of the anchor driver 114 (with the suture anchor 10) extends through the first channel 110 up to, but not into, the convergence region 130. After the pilot hole is drilled and the drill bit 116 is removed, the anchor driver 114 (with the suture anchor 10) is free to move through the convergence region 130 and out of the distal tube and guide tip 128, as shown in the post-drilling configuration of FIG. 7.

[0035] Referring briefly to FIG. 8, there is shown a schematic view of an enlarged cross-sectional first side 103 of second channel 112 of multi-barrel drill guide and anchor placement assembly 100 of FIG. 7. In the illustrated embodiment, drill bit 116 has been removed from assembly 100 after pilot holes have been drilled. As shown in FIG. 7, anchor driver 114 is free to advance along first channel 110 via sliding inserter 118. Sliding inserter 118 is free to move distally along track 113 because drill bit 116 is not in a position to act as a locking mechanism 133 between sliding inserter 118 and elongate body 102.

[0036] 9, a schematic view of an enlarged first side 103 of a shallow deployment button 136 of a multi-barrel drill guide and anchor deployment assembly 100 in a pre-activated / undeployed configuration is shown, according to an embodiment. The shallow deployment button 136 is located between the proximal end 104 and the distal end 106 of the elongate body 102. In the illustrated embodiment, the shallow deployment button 136 is located or otherwise positioned within a recess 137 in the first side 103 of the elongate body 102. However, the shallow deployment button 136 may be located in other suitable positions along the elongate body 102. As shown in FIG. 9, the shallow deployment button 136 is substantially flush with the first side 103 of the elongate body 102, preventing potential interference with use of the assembly 100 before the suture anchor 10 is deployed.

[0037] 9, shallow placement button 136 is hingedly connected to elongated body 102 within recess 137. In the illustrated embodiment, one side of shallow placement button 136 is , connected to elongate body 102 via hinge 138 in recess 137. In a pre-actuated / non-deployed configuration (shown in FIG. 9 ), shallow deployment button 136 has a flange 139 that extends from recess 137 to first opening 107 (formed in the top of handle 108 and / or elongate body 102). In particular, flange 139 extends into the path of track 113.

[0038] 10, there is shown a schematic view of an enlarged cross-sectional second side 105 of the shallow placement button 136 of the multi-barrel drill guide and anchor placement assembly of FIG. 9. In the post-drilling configuration, as described above, the sliding inserter 118 is free to advance along the track 113. The sliding inserter 118 moves along the track 113 until a portion 140 of the sliding inserter 118 contacts a flange 139 of the shallow placement button 136 that extends in the path of the track 113, as shown in FIG.

[0039] 11 , a schematic diagram of an enlarged first side 103 of the shallow deployment button 136 of the multi-barrel drill guide and anchor placement assembly 100 in an actuated / undeployed configuration is shown, according to an embodiment. After the portion 140 of the sliding inserter 118 contacts the flange 139 of the shallow deployment button 136 of FIG. 10 , continuing to advance the sliding inserter 118 distally causes the portion 140 of the sliding inserter 118 to apply a force to the flange 139. The force on the flange 139 causes the shallow deployment button 136 to rotate about the hinge 138, thereby rotating the shallow deployment button 136 out of the recess 137 and into the actuated / undeployed configuration. The portion 140 of the sliding inserter 118 applies a force to the flange 139 until the flange 139 rotates out of the path of the track 113. Once flange 139 exits the path of track 113, sliding inserter 118 can be advanced distally along track 113 to insert suture anchor 10 into the pilot hole. As flange 139 exits the path of track 113, passing filament 11 extends into first channel 110 and into first opening 107 of elongate body 102 between flange 139 and feature 142 of first opening 107.

[0040] 12-13, an enlarged rear / perspective view and a schematic rear view of shallow deployment button 136 of FIG. 11 are shown. FIGS. 12-13 show shallow deployment button 136 in an actuated / undeployed configuration after being rotated out of recess 137. Shallow deployment button 136 includes an indicator 141 that provides instructions for the user. In the illustrated embodiment, indicator 141 is an arrow pointing downward toward feature 142 on elongate body 102. To deploy and release suture anchor 10 from assembly 100 (as described in detail below), the user presses shallow deployment button 136, pushing downward toward feature 142 (i.e., toward indicator 141).

[0041] 14-15 , there is shown a first side 103 view and an enlarged rear schematic view of the anchor driver 114 of the multi-barrel drill guide and anchor placement assembly 100 in an activated / undeployed configuration, according to an embodiment. When the flange 139 rotates out of the path of the track 113, the sliding inserter 118 can advance distally along the track 113. As the sliding inserter 118 moves distally, the anchor driver 114 connected thereto moves distally out of the distal tube and guide tip 128, as shown in FIG. 14 . The anchor driver 114 (and sliding inserter 118) are advanced until the suture anchor 10 loaded on the distal end 115 of the anchor driver 114 is fully inserted into the pilot hole. When the sliding inserter 118 is advanced as far as possible, the proximal end surface 143 of the sliding inserter 118 is substantially flush with the proximal end surface 144 of the elongate body 102, as shown in FIG. 15. The substantial alignment of the proximal end surface 143 of the sliding inserter 118 with the proximal end surface 144 of the elongate body 102 indicates that the suture anchor 10 is fully inserted into the pilot hole. Provide confirmation to the user.

[0042] 16, a schematic view of the proximal end 104, 119 of the elongate body 102 and the enlarged first side 103 of the sliding inserter 118 of FIG. 14 is shown. In the illustrated embodiment, the suture anchor 10 on the distal end 115 of the anchor driver 114 is fully inserted into the pilot hole. As such, the proximal end surface 143 of the sliding inserter 118 is substantially flush with the proximal end surface 144 of the elongate body 102. As shown in FIG. 16, the portion 140 of the sliding inserter 118 includes a shallow channel 145. In the illustrated actuated / undeployed configuration, the shallow channel 145 substantially aligns with the hinge 138 on the feature 142 on the elongate body 102. When shallow channel 145 is substantially aligned with hinge 138 on feature 142, the user can press or apply pressure / force downward on shallow deployment button 136 (in the direction of indicator 141) toward feature 142. Shallow deployment button 136 moves downward via hinge 138 and through shallow channel 145 toward feature 142, deploying suture anchor 10.

[0043] 17 , there is shown a schematic view of an enlarged first side 103 of a suture anchor 10 in an undeployed state on an anchor driver 114 of a multi-barrel drill guide and anchor placement assembly 100. In the illustrated embodiment, the suture anchor 10 is shown in an undeployed state loaded onto the anchor driver 114 (extending from a distal tube or guide tip 128). In the particular embodiment of the suture anchor 10 of FIG. 17 , the suture anchor 10 includes a first arm 12 and a second arm 13 that extend proximally toward the distal tube or guide tip 128 in the undeployed state.

[0044] 18 , there is shown a schematic view of an enlarged first side 103 of the shallow deployment button 136 of the multi-barrel drill guide and anchor deployment assembly 100 in an activated / deployed configuration, according to an embodiment. After the anchor driver 114 is fully advanced and the suture anchor 10 is fully inserted into the pilot hole, the suture anchor 10 must be deployed and then released from the assembly 100. To deploy the suture anchor 10, the user presses or applies a force downward on the shallow deployment button 136 (in the activated / deployed configuration), as described above, resulting in the activated or deployed configuration shown in FIG. 18 .

[0045] 19, an enlarged side / rear perspective schematic view of the shallow deployment button 136 of FIG. 18 is shown. When the shallow deployment button 136 is pushed downward through the shallow channel 145 toward the feature 142 of the elongate body 102, the flange 139 pushes or otherwise displaces the passing filament 11 toward the feature 142, creating a new, longer path for the passing filament 11. In the illustrated embodiment, the assembly 100 has an additional indicator window 146 formed in the handle 108 (and / or the elongate body 102). The indicator window 146 includes a shallow deployment clicker 147 and a bump 148. The shallow deployment button 136 is connected to the shallow deployment clicker 147 such that when the shallow deployment button 136 is pushed downward into the activated / deployed configuration, the shallow deployment clicker 147 deflects onto the bump 148 of the indicator window 146, which is visible to the user. In an additional embodiment, movement of the shallow deployment clicker 147 over the bump 148 of the indicator window 146 produces an audio sound (e.g., a click) to additionally communicate to the user that the shallow deployment button 136 is in the activated / deployed configuration and that the suture anchor 10 has reached the deployed state.

[0046] Referring now to FIG. 20, a suture anchor in a deployed state on the distal end 115 of the anchor driver 114 of the multi-barrel drill guide and anchor placement assembly 100. A schematic view of an enlarged first side 103 of suture anchor 10 is shown. From the undeployed state (shown in FIG. 17), actuation of shallow deployment button 136 and deployment 136 displaces the path of passing filament 11, effectively removing slack and pulling passing filament 11 proximally. As passing filament 11 is pulled proximally, first arm 12 and second arm 13 of suture anchor 10 rotate distally toward each other (as the anchor is prevented from being pulled proximally by the force applied in the opposite direction by the distal end of the anchor driver), as shown in FIG. 20 (and described below with reference to FIGS. 22-29). This causes suture anchor 10 to further collapse into the pilot hole, forming a wedge wider than the drill diameter and locking suture anchor 10 in place.

[0047] 21 , there is shown a schematic view of an enlarged first side 103 of the suture anchor 10 of FIG. 20 with the multi-barrel drill guide and anchor deployment assembly 100 removed. In the deployed state, as shown in FIGS. 20-21 , the suture anchor 10 is removed from the assembly 100 by unwrapping or otherwise unwinding the passing filament 11 from one or more notches 121 and flexible block 122 at the proximal end 119 of the sliding inserter 118.

[0048] 22-29, various schematic diagrams of an embodiment in which the suture anchor 10 is a shallow Y-Knot® are shown. One such suture anchor is disclosed in U.S. Patent Application No. 15 / 687,040, assigned to the assignee of the present application and incorporated herein by reference in its entirety. The shallow Y-Knot® suture anchor 10 embodiment illustrated in FIGS. 22-29 is a fibrous construct (fixation body) 20 having at least one passing filament 21 braided therethrough. The fibrous construct 20 includes a first arm 22 and a second arm 23 (as the first and second arms 12, 13 shown in FIG. 17) having a proximal side 24 and a distal side 25 extending therebetween. The passing filament 21 has a first end 26 and a second end 27 braided through the fibrous construct 20 in a T-shape in an undeployed (or pre-deployed) configuration. Importantly, fibrous construct 20 is thicker than passing filament 21, providing fibrous construct 20 with greater tensile strength (compared to filament 21) to minimize creep toward the top / proximal end of the pilot hole. When further tension is applied to passing filament 21, fibrous construct 20 is configured to flare and wedge into the bottom of the pilot hole to lock into place (based on the specific placement of passing filament 21 through fibrous construct 20, its force and position imparted by a placement device (e.g., anchor driver 114) on fibrous construct 20, and the properties of fibrous construct 20 itself).

[0049] 23 illustrates one embodiment of pass locations 28 on a fibrous construct 20. As shown, pass filaments 21 enter and exit the proximal and distal sides 24, 25 of the fibrous construct 20 at multiple pass locations 28. The fibrous construct 20 is then loaded onto an anchor placement device / inserter, such as the anchor driver 114 described above. Importantly, the fibrous construct 20 is positioned within the anchor driver 114 such that a first end 26 of the filament 21 extends along a first side 29 of the anchor driver 114 and a second end 27 of the filament 21 extends along a second side 30 of the anchor driver 114.

[0050] The placement of the fibrous construct 20 will now be further described and illustrated with reference to Figures 24-29. As shown in Figure 24, the fibrous construct 20 is implanted into a pre-formed pilot hole 31 by an anchor driver 114. Once the fibrous construct 20 is loaded onto the anchor driver 114 (or other placement device), the anchor driver 114 is used to drive the fibrous construct 20 into a narrow pre-formed pilot hole 31 (e.g., 10 mm deep). Such a narrow pilot hole 31 may be used to further expand the fibrous construct 20, such as to fill the distal bone, if necessary. They often form in smaller bones.

[0051] As the fibrous construct 20 enters the narrow pilot hole 31, the first and second arms 22, 23 of the fibrous construct 20 begin to fold or otherwise bend proximally toward the narrow width of the pilot hole 31, as shown in FIG. 24 (also shown in FIG. 17 ). Next, to deploy the fibrous construct 20, the anchor driver 114 is held in place and fully inserted into the pilot hole 31, while the first and second ends 26, 27 of the passing filament 21 are under tension and pulled proximally away from the fibrous construct 20. As the first and second ends 26, 27 of the passing filament 21 are pulled, the length of the fibrous construct 20 between each of the passing positions 28 is drawn closer together as slack in the passing filament 21 between the passing positions 28 is minimized. As a result, the first and second arms 22, 23 of the fibrous construct 20 begin to rotate distally, as shown in FIG. 25 .

[0052] To continue positioning of the fibrous construct 20, the first and second ends 26, 27 of the passing filament 21 are increasingly pulled apart proximally, away from the fibrous construct 20, reducing additional slack in the passing filament 21 between pass locations 28 of the fibrous construct 20. As a result, the first and second arms 22, 23 of the fibrous construct 20 continue to fold or otherwise tighten distally, as shown in FIGS. 26-27 , and pleats 32 begin to form between adjacent pass locations 28. The added tension draws the first and second arms 22, 23 of the fibrous construct 20 closer together toward the central longitudinal axis xx through the fibrous construct 20. As a further result, the pleats 32 become more defined, as shown in FIG. 28 .

[0053] Thereafter, as shown in Figure 29 (and Figure 21), the first and second ends 26, 27 of the passing filament 21 are pulled until no slack remains between adjacent pass locations 28 of the fibrous construct 20. Applying additional tension to the first and second ends 26, 27 of the passing filament 21 strengthens the fibrous construct 20 by forcing the fibrous construct 20 to widen or expand the pilot holes 31 until it reaches a fully deployed configuration, as shown in Figure 29. As the fibrous construct 20 compresses or shortens, it expands in a direction perpendicular to its length (i.e., width or thickness), setting and securing the anchors in place within the pilot holes 31.

[0054] The pleats 32 form a mattress thickness stack, effectively increasing the diameter (measured relative to the central longitudinal axis xx of the fibrous construct 20 and pilot hole 31). This relative increase in size relative to the distance from the central longitudinal axis xx of the pilot hole 31 results in a retention force of the fibrous construct 20, including the aforementioned width and / or thickness expansion. In other words, the Poisson's ratio of the growth in width and / or mattress thickness during a decrease in length provides an additional increase in deployment size to the increase in force of the pleats 32 of the fibrous construct 20. Poisson's ratio defines the proportional decrease in length measurement relative to the proportional increase in length within a sample of elastically expanded material. Thus, if a material is compressed in the x-direction, for example, the material will expand in the y- and / or z-directions.

[0055] The passing filament 21 can be removed from the fibrous construct 20 by pulling on either end 26, 27 until the entire passing filament 21 is removed. The final configuration of the fibrous construct 20 in the deployed state allows the passing filament 21 to easily slide through when the fibrous construct 20 is set and secured within the pilot hole 31. That is, the tensile strength of the fibrous construct 20 in this configuration is sufficient to keep the fibrous construct 20 in place while the passing filament 21 is easily removed.

[0056] The deployment of the fibrous construct 20, according to another embodiment, is further described and illustrated with reference to FIGS. 29A-29C. FIG. 29A shows the fibrous construct 20 in an undeployed position similar to the fibrous construct 20 in FIG. 24. FIG. 29B shows the fibrous construct 20 in a halfway position to full deployment, and FIG. 29C shows the fibrous construct 20 in a fully deployed configuration. Key differences between the embodiment shown in FIGS. 24-29 and the embodiment shown in FIGS. 29A-29C include, for example, the slack line (number "21" written on the line) running across the side of the inserter 114 in FIG. 29A, where the slack line runs across the distal end and partially within the fork cross-section of the inserter 114 in FIG. 24. Other positioning configurations of the passing filament 21 through the fibrous construct 20 that enable the fibrous construct to perform the same or similar functions are contemplated and are within the scope of this disclosure (and should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0057] 30-36, various schematic views of an embodiment of a multi-barrel drill guide and anchor placement assembly 100 are shown, where the suture anchor 10 is, for example, a Y-Knot® anchor 40, and may be any full suture anchor configured to perform the same functions as described herein (as should be understood by those skilled in the art in conjunction with a review of this disclosure). Assembly 100 is shown having a Y-Knot® full suture anchor. One such suture anchor is disclosed in U.S. Pat. No. 9,826,971, assigned to the assignee of the present application and incorporated herein by reference in its entirety. In the illustrated embodiment, and as described above, drill bit 116 is loaded into convergence region 130 within second channel 112, such that drill bit 116 acts as a locking mechanism 133 to ensure sliding inserter 118 does not move during shipping or handling until drill bit 116 is used and removed. In the illustrated embodiment of assembly 100 shown in FIG. 30, in addition to having a different full suture anchor, assembly 100 does not have shallow deployment button 136 or shallow deployment clicker 147 of the embodiment of assembly 100 of FIGS. 1-22. Otherwise, assembly 100 is identical to assembly 100 described and illustrated with respect to FIGS. 1-20.

[0058] Figure 31 shows the drill bit 116 after drilling the appropriate depth for the pilot hole in the bone. As with the other embodiments of the assembly 100, the depth stop 126 on the drill bit 116 contacts the opening 123 in the sliding inserter 118, allowing the user to know when the appropriate depth has been reached. Figure 32 shows the assembly 100 after the drill bit 116 has been removed. The sliding inserter 118 is now free to advance along the track 113 and insert the Y-Knot® 40 into the pilot hole. Figure 33 shows the assembly 100 after all suture anchors 40 have been fully inserted and deployed into the pilot holes, while Figure 34 shows all suture anchors 40 deployed after the assembly 100 has been removed.

[0059] An embodiment of a Y-Knot® anchor (or soft anchor or "full suture" anchor) 40 is shown in detail in FIGS. 35-36. As shown in FIGS. 35-36, the full suture anchor 40 includes at least two sections: at least one filament 41, which is the suture to be secured, and a fibrous construct (anchor body) 40, which forms the portion of the anchor that can increase in width, thickness, and / or diameter and contract in length as part of deployment. FIG. 35 shows the fibrous construct 40 in an undeployed state, while FIG. 36 shows the "shortened" and "expanded" fibrous construct 40 in a deployed state, additive to the increase due to pleating. This soft anchor embodiment also utilizes Poisson's ratio, which captures the following cause and effect relationship: That is, compressing a material in a first direction causes it to expand in a direction perpendicular to the first direction (i.e., if compressed in the x direction, the material will expand in the y and / or z directions), and stretching / stretching a material in a first direction causes it to contract in a direction perpendicular to the first direction. It should be understood that while it is fibrous construct 40 that increases in size and / or diameter, filament 41 also plays a role in anchor placement, albeit freely sliding (in some embodiments) and not (at least at certain locations or points) in other embodiments relative to fibrous construct 40. Filament 41 helps position, align, and support fibrous construct 40 such that when filament 41 is removed from fibrous construct 40 after anchor placement, fibrous construct 40 is free to spill (i.e., release), causing fibrous construct 40 to collapse and shrink in size, allowing for easy (and potentially undesirable) removal.

[0060] In other words, the fibrous construct 40 has two primary functions. First, it provides a base for the filaments 41 to slide within. Second, when compressed and / or pleated during deployment, the fibrous construct 40 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness, or diameter and creating retention capabilities. This effect of changing the shape of the fibrous construct 40 to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure an anchor in a hole or against bone or soft tissue. It is the combination of an expanding fibrous construct 40 coupled with filaments 41 that remain slidable (in some embodiments, and at least at certain locations or points during use, in other embodiments, non-slidable) with respect to the fibrous construct 40 that makes embodiments of the present invention ideal for soft tissue reattachment to bone or soft tissue where passing through a sliding knot is desired to secure repair.

[0061] The following discussion relates to a disposable drill and two different anchor driver alternative embodiments.

[0062] Referring to FIG. 37 , a side schematic diagram of a disposable drill 300 with a pre-installed drill bit 302 is shown according to an alternative embodiment. This disposable drill 300 and pre-installed drill bit 302 can be used in place of or separately / independently from the drill bit 116 described above. The disposable drill can include, but is not limited to, a motor 301, a drill bit 302 attached to the motor having a specific / predetermined length configured to create a pilot hole of a desired length / depth for a particular procedure, a disposable battery 303 configured to power the motor, and at least one switch 304 configured to be actuated (rotationally, linearly, perpendicular to the longitudinal axis of the device (“pushed”)) by a user to turn on the drill bit 302 and / or set a desired speed for the drill bit 302. The disposable drill 300 can also include a disposable plastic housing 305 to make the device lighter, less expensive, and disposable. The disposable plastic housing 305 can be made from any plastic or combination of plastics.

[0063] As described above, during suture anchor placement, a pilot hole is typically created in the bone before the anchor is inserted. The pilot hole is typically formed using a drill bit to drill a hole for anchor placement. However, traditionally, the drill handpiece and battery must be sterilized and ready for use in surgery. Also, because the drill bit typically drills to a specific depth through the drill guide, a hard stop feature may be required on the drill guide. Alternatively, a hard stop feature can be placed at a specific location on the drill handpiece to create an appropriate hard stop for the drill guide (as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0064] By providing a disposable drill 300, according to an embodiment, there is no need for an additional drill handpiece and battery that is sterilized prior to a surgical procedure. With the pre-mounted drill bit 302, the disposable drill 300 is ready to use out of the package and does not require the additional step of mounting the drill bit onto the drill handpiece.

[0065] Generally, two alternative driver designs described and illustrated below are configured to operate on the same concept of pulling the suture tail posteriorly / proximally from the anchor to deploy the anchor (see, e.g., FIGS. 18-21 and related discussion). The alternative driver designs may be used in place of the anchor driver 114 described above, or may be used separately / independently. Each of the anchor driver devices described and illustrated below works in conjunction with an all-suture soft tissue fixation device having a suture configured to slide after the anchor is deployed. Many procedures involving distal soft tissue fixation require having an anchor that can be deployed in a relatively shallow hole with a narrow diameter (compared to other locations in the body). The uniqueness of the all-suture soft tissue fixation device relates, in part, to the braiding of the suture through the anchor, which allows the anchor to be fully deployed into the bone tunnel (at the bottom of the bone tunnel) while the driver is still inserted. The pattern in which the suture is braided through the anchor is unique in that it preferably does not start and end at the tip of the anchor (although it is possible to do so). Instead, they start very close to the center, are braided distally at one end to the opposite tip, and are braided back to the center near the starting point. Such a configuration is illustrated in FIG. 38. As shown, all fully sutured soft tissue fixation devices include a fibrous construct (fixation body) 20 (e.g., a No. 5 suture) with at least one passing filament 21 (e.g., a No. 0 suture) braided therethrough, similar to the shallow Y-Knot® embodiment suture anchor 10 shown and described in FIGS. 22-29. Braiding the suture / filament 21 through the fibrous construct 20 allows the anchor to be deployed while still on the driver by pulling the first and second ends 26, 27 of the passing filament 21 (as in FIGS. 18-21, 25-29, and as described above and below). The driver design allows for insertion of the anchor into the bone tunnel without the use of an additional guide, and the anchor can be rapidly deployed by actuation means (e.g., by squeezing or pushing a lever). After the anchor is deployed, the driver can be removed and the suture can be slid through the anchor.39-56 illustrate one alternative embodiment of anchor driver 200, and FIGS. 57-62 illustrate another alternative embodiment of anchor driver 400. As shown in FIG.

[0066] Referring to FIG. 39 , a side perspective view of an alternative embodiment of an anchor driver 200 is shown. The anchor driver 200 may include, but is not limited to, a forked distal driver tip 201 for positioning the suture anchor 10 in a bone hole (not shown). A depth stop 202 is positioned proximal to the forked distal driver tip 201 and configured to ensure the driver is inserted a predetermined depth (e.g., 10 mm) into the bone hole. A lever arm 203 configured to move a suture attached to the anchor 10 to deploy the anchor 10 (see below) is shown. A spool retaining arm 206 is also shown and is configured to hold the suture spool 205 (described in more detail below) in a locked position until the spool 205 is intentionally released by the user. The anchor driver 200 may include a housing / cover (not shown) that covers the internal components. The anchor driver 200 is shown open without the housing / cover to allow illustration of the internal components.

[0067] Referring to FIG. 40, a slot 207 is provided in the anchor driver 200 in which the spool 205 is located. The slot 207 includes teeth 207A configured to engage and lock the teeth 205A of the spool when the spool 205 is fully inserted into the locked position (FIG. 41). The spool retaining arm 206 is also configured to engage and lock the teeth 205A of the spool when the spool 205 is fully inserted into the locked position. (FIG. 41) A perspective view of spool 205 is shown in FIG. 41 and includes portions for winding sutures 205B and 205C, and teeth 205A.

[0068] 42 and 43, perspective views of the safety bar 204 alone and the safety bar positioned within the anchor driver 200, respectively, are shown. As shown in FIG. 43, the anchor driver 200 is fully assembled (excluding the optional housing / cover), and the spool 205 is shown in a locked position with its lateral surface 208 positioned a predetermined distance out from a side surface 209 of the anchor driver 200. In the locked position, a portion of the teeth 207A of the slot 207 is in contact with a portion of the teeth 205A of the spool 205, and the spool retaining arm 206 is positioned between another portion of the teeth 205A of the spool 205. Additionally, the safety bar 204 is shown positioned in the slot of the anchor driver 200 beneath the lever arm 203 (configured to prevent the lever arm from contacting the suture limbs 26 and 27). An anchor 10 is also positioned on the forked distal driver tip 201.

[0069] FIG. 44 is a top perspective view of the distal end of anchor driver 200 showing anchor 10 positioned on forked distal driver tip 201 (in the undeployed configuration / position) and ready for insertion into a bone hole.

[0070] 45 is a side perspective view of spool 205 in the locked position (as described above). As shown, lateral surface 208 is positioned a predetermined distance out from side 209 of anchor driver 200 to form a spool release button.

[0071] 46 is a side perspective view of spool 205 in an unlocked / released position, where lateral surface 208 has been pressed / actuated by a user to be substantially flush with side surface 209 of anchor driver 200. This position of spool 205 disengages teeth 205A of spool 205 from teeth 207A of slot 207 and from spool retaining arm 206, allowing spool 205 to freely spin and unwind suture.

[0072] A method of using the anchor driver 200 will now be described. Briefly, the anchor driver 200 is preferably configured to be a single-use device and is preferably packaged as shown in FIG. 47 (a side perspective view of the anchor driver 200 in an undeployed configuration). After drilling a bone hole / tunnel (e.g., a 10 mm deep and 1.5 mm diameter hole), the anchor driver 200 is inserted into the bone tunnel by striking the rear of the driver (as should be understood by those skilled in the art in conjunction with a review of this disclosure). When the built-in depth stop 202 is flush with the top surface of the bone, the safety bar 204 is released and the lever arm 203 is compressed to deploy the anchor 10 (see FIGS. 48-54). After the anchor 10 is deployed, the lateral surface 208 of the spool 205 is pushed inward and flush with the side surface 209 of the driver body, and the driver 200 is removed from the insertion site (FIG. 55). By removing the driver 200 while holding the spool 205 in the released position, the suture tails 26, 27 will unwind and become free from the driver (FIG. 56).

[0073] Referring to FIG. 48, safety bar 204 is shown removed (preferably after anchor 10 is fully inserted into the bone hole) to allow placement of anchor 10.

[0074] Referring to FIG. 49, lever arm 203 is actuated and depressed by the user (similar to the embodiment shown and described in connection with FIGS. 18-21) to deflect suture tails 26, 27 to deploy anchor 10 (only from the anchor / distal side, not the spool proximal side since the spool is in the locked position).

[0075] Referring to FIG. 50, the tail of the anchor 10 is shown to begin to flip and point in the opposite / distal direction when the suture 21 slack is removed from the anchor by pressing on the lever arm 203.

[0076] 51 and 52, the lever arm 203 is shown depressed approximately halfway onto the suture limbs 26, 27 to further deploy the anchor 10.

[0077] 53 and 54, the lever arm 203 is shown fully depressed onto the suture limbs 26, 27 to fully deploy the anchor 10 (preferably at the base of the bone hole).

[0078] Referring to FIG. 55, the lateral surfaces 208 of the spool 205 are shown pressed flush against the sides 209 of the driver body and the driver 200 is removed from the insertion site to unwind the suture.

[0079] Referring to FIG. 56, the anchor 10 is shown in its fully deployed state (preferably at the bottom of the bone hole) after the anchor driver 200 has been removed.

[0080] Referring to FIG. 57 , a side perspective view of an alternative embodiment of an anchor driver 400 is shown. The anchor driver 400 may include, but is not limited to, a forked distal driver tip 401 for positioning the suture anchor 10 in a bone hole (not shown). A depth stop 402 is positioned proximal to the forked distal driver tip 401 and configured to ensure the driver is inserted a predetermined depth (e.g., 10 mm) into the bone hole. A lever arm 403 is shown, which is configured to move a suture attached to the anchor 10 to deploy the anchor 10 by pushing a sliding cleat 405 attached to the proximal end of the suture tail 26, 27 proximally through a channel or groove 407 (described further below). A safety lever 404 is also shown, which is configured to prevent actuation of the lever arm 403 until the appropriate time. A cleat release notch 406 is also shown, which is configured to prevent the cleat 405 from falling freely from the anchor driver 400 after the anchor 10 has been deployed. As shown in FIG. 58, the anchor driver 400 may include a housing / cover 408 to cover the internal components (in many of these figures, the anchor driver 400 is shown open without the housing / cover so that the internal components can be illustrated).

[0081] As shown in additional figures identified below, the lever arm 403 is configured to push the sliding cleat 405 back / proximally a predetermined distance (e.g., approximately 10 mm, which is an appropriate distance for deploying the anchor 10). After pushing the cleat 405 proximally a certain distance, the lever arm 403 is configured to be fully disposed outside of the channel 407 of the sliding cleat 405. As such, the sliding cleat 405 is configured to slide freely up to the cleat release notch 406 at the distal end of the driver 400. At this point, the driver 400 can be removed from the insertion site, and the cleat 405 can be separated from the driver 400 by pulling on the suture tails 26, 27.

[0082] A method of using anchor driver 400 will now be described. Briefly, anchor driver 400 is preferably configured to be a single use device and is preferably packaged as shown in FIG. 58 (a side perspective view of anchor driver 200 in an undeployed configuration). After drilling a bone hole / tunnel (e.g., a 10 mm deep and 1.5 mm diameter hole), anchor driver 400 is inserted into the driver's The driver 400 is inserted into the bone tunnel by striking the rear (as should be understood by those skilled in the art in conjunction with a review of this disclosure). When the built-in depth stop 402 is flush with the top surface of the bone, the lever arm 403 can be actuated (e.g., squeezed) by the user to pull the suture tails 26, 27 and push the sliding cleat 405 proximally to deploy the anchor (see FIG. 60). Once the lever arm 403 is fully depressed, the driver 400 can be removed from the insertion site, and the sliding cleat 405 is configured to retract from the front of the driver (see FIGS. 61 and 62). Finally, the suture can be released from the sliding cleat 405, and the suture tail can be pulled to deploy the anchor.

[0083] Referring to FIG. 59, anchor driver 400 is shown in the undeployed / unactuated position, ready to deploy anchor 10 into a bone hole (not shown).

[0084] Referring to FIG. 60, the anchor driver 400 clears the channel 407 after the lever arm 403 is actuated, indicating that the anchor 10 is deployed.

[0085] Referring to FIG. 61, slide cleat 405 is shown positioned in release notch 406 and moved through channel 407 after driver 400 has been removed from the insertion site.

[0086] Referring to FIG. 62, the slide cleat 205 is now completely removed from the driver 400 and is ready to be released through the suture tails 26, 27 into the anchor 10.

[0087] Filament or suture, as that term is used and described herein, includes braided (i.e., multifilament) sutures and monofilament sutures, as well as any other metallic or non-metallic filament or wire-like material suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials.

[0088] While embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by those skilled in the art that various changes in detail can be made therein without departing from the spirit and scope of the invention as defined by the claims, which may be supported by the written description and drawings. Furthermore, when an exemplary embodiment is described with reference to a particular number of elements, it will be understood that the exemplary embodiment may be implemented utilizing any of the particular number of elements or less.

Claims

1. A multi-barrel drill guide, an elongate body extending along a longitudinal axis having a proximal end and a distal end, the elongate body having a handle extending from the elongate body between the proximal and distal ends; an elongate distal guide tube attached to and extending distally from the distal end of the elongate body; a sliding inserter movably connected to the elongate body so as to be configured to move between the proximal end and the distal end of the elongate body; a first channel extending from the proximal end to the distal end of the elongate body; a second channel extending from the distal end along the elongate body to a location between the distal end and the proximal end, the second channel extending at an angle relative to the first channel; a convergence region at the distal end where the first channel and the second channel intersect.

2. The multi-barrel drill guide of claim 1 , further comprising a locking mechanism configured to selectively lock the sliding inserter in place relative to the elongate body.

3. The multi-barrel drill guide of claim 2 , wherein the locking mechanism includes an opening in the sliding inserter selectively aligned with an opening in the elongated body that extends into the second channel.

4. The multi-barrel drill guide of claim 1 , wherein the converging region extends to a single exit point.

5. The multi-barrel drill guide of claim 4 , wherein the single exit point is at a distal end of the elongate distal guide tube.

6. The drill guide of claim 1 , further comprising a portion of the second channel extending at an angle relative to the longitudinal axis that is different from a remainder of the second channel.

7. The multi-barrel drill guide system of claim 1 , wherein the second channel curves away from the handle.

8. The multi-barrel drill guide of claim 1 , further comprising a slit on the exterior of the elongated body that extends into the first channel.

9. 1. A multi-barrel drill guide system, comprising: an elongate body extending along a longitudinal axis having a proximal end and a distal end, the elongate body having a handle extending from the elongate body between the proximal and distal ends; an elongate distal guide tube attached to and extending distally from the distal end of the elongate body; a sliding inserter movably connected to the elongate body so as to be configured to move between the proximal end and the distal end of the elongate body; a first channel extending from the proximal end to the distal end; a second channel extending from the distal end along the elongate body to a location between the distal end and the proximal end, the second channel being at an angle to the first channel; a suture anchor disposed entirely within the first channel and movable in a slidable manner; And, a drill bit slidably movable within the second channel.

10. The multi-barrel drill guide system of claim 9 , wherein the suture anchor is loaded onto a driver that is slidably movable within the first channel.

11. The multi-barrel drill guide system of claim 9 , further comprising a locking mechanism configured to selectively lock the sliding inserter in place relative to the elongate body.

12. The multi-barrel drill guide system of claim 11 , including an opening in the sliding inserter selectively aligned with an opening in the elongate body that extends into the second channel.

13. 13. The multi-barrel drill guide system of claim 12, wherein in the locked position, the drill bit extends through the opening in the sliding inserter and the opening in the elongate body and into the second channel.

14. The multi-barrel drill guide system of claim 10 , further comprising a shallow alignment button hinged within a recess on the elongate body.

15. 15. The multi-barrel drill guide system of claim 14, wherein the driver is connected to the sliding inserter, sliding the driver distally along the first channel to rotate the shallow placement button away from the recess.

16. 10. The multi-barrel drill guide system of claim 9, further comprising a bent portion of the second channel that extends at an angle relative to the longitudinal axis different from a remainder of the second channel.

17. The multi-barrel drill guide system of claim 9 , wherein the second channel curves away from the handle.

18. 1. A method of drilling a pilot hole and inserting a suture anchor, the method comprising: providing a multi-barrel drill guide and anchor placement assembly having an elongate body extending along a longitudinal axis having a proximal end and a distal end, a handle extending from the elongate body between the proximal end and the distal end, an elongate distal guide tube attached to the distal end of the elongate body and extending distally, a sliding inserter movably connected to the elongate body such that the sliding inserter is configured to move between the proximal and distal ends of the elongate body, a first channel extending from the proximal end to the distal end, a second channel extending from the distal end to a location between the distal and proximal ends of the elongate body, the second channel extending at an angle relative to the first channel, and a convergent region at the distal end where the first and second channels intersect; inserting a suture anchor loaded on an anchor driver into the first channel; inserting a drill bit through an opening on the sliding inserter and an opening on an elongated body extending into the second channel; positioning the distal end of the distal guide tube relative to a bone; extending the drill bit through the second channel, the convergence region and the distal guide tube; and drilling a pilot hole into the bone with the drill bit. 。

19. retracting the drill bit through the opening on the sliding inserter; 20. The method of claim 18, further comprising extending the anchor driver through the first channel and the converging region.

20. 20. The method of claim 19, further comprising implanting the suture anchor into the pilot hole.

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