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IPP-0051-US14 cross roads FIG. 97 is a perspective view of a driver for use with the system of FIG. 66 and the implant of FIG. 52 according to one embodiment; 85 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 98 is a perspective view illustrating use of the system of FIG. 66 and the implant of FIG. 52 according to one embodiment in another stage of the sequence illustrated in FIGS. 93-96; 86 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 99 is a perspective view of a driver for use within the system of FIG. 66 and the implant of FIG. 52 according to one embodiment; 87 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 100-101 are a sequence of perspective views illustrating use of the system of FIG. 66 and the implant of FIG. 52 according to one embodiment; 88 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 102 is a section view illustrating use of the system of FIG. 66 and the implant of FIG. 52 according to one embodiment; 89 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 103 is a close-up section view illustrating part of FIG. 102 according to one embodiment; and 90 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 104 is a close-up section view illustrating part of FIGS. 102 and 103 according to separation stage of the implant of FIG. 52 according to one embodiment. 91 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads The following illustrative examples depict implants, instruments and methods to anchor a suture to a bone. The illustrative examples depict anchoring a round suture in a bone tunnel to attach soft tissue to the bone. However, examples of instruments and methods of the present disclosure may be used to anchor other elements in a bone tunnel including suture tapes, cables, soft tissues, grafts, and other elements. While illustrative examples of methods depict the attachment of the soft tissue of the rotator cuff to a humeral bone, it will be understood that examples of instruments and methods of the present disclosure may be used to anchor any member in any bone, at surgical sites anywhere in a patient’s body, and for any purpose. 92 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Standard medical planes of reference and descriptive terminology are employed in this specification. While these terms are commonly used to refer to the human body, certain terms are applicable to physical objects in general. A standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. A mid-sagittal, mid-coronal, or mid-transverse plane divides a body into equal portions, which may be bilaterally symmetric. The intersection of the sagittal and coronal planes defines a superior-inferior or cephalad-caudal axis. The intersection of the sagittal and transverse planes defines an anterior-posterior axis. The intersection of the coronal and transverse planes defines a medial-lateral axis. The superior-inferior or cephalad-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular. Anterior means toward the front of a body. Posterior means toward the back of a body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of a body, particularly toward a plane of bilateral symmetry of the body. Lateral means away from the midline of a body or away from a plane of bilateral symmetry of the body. Axial means toward a central axis of a body. Abaxial means away from a central axis of a body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. 93 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Proximal means toward the trunk of the body. Proximal may also mean toward a user or operator. Distal means away from the trunk. Distal may also mean away from a user or operator. Dorsal means toward the top of the foot. Plantar means toward the sole of the foot. Antegrade means forward moving from a proximal location/position to a distal location/position or moving in a forward direction. Retrograde means backward moving from a distal location/position to a proximal location/position or moving in a backwards direction. 94 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads The terms “suture” and/or “suture strand” are used herein to mean any strand or flexible member, natural or synthetic, able to be anchored in a bone tunnel and useful in a surgical procedure. In certain embodiments, “suture” and/or “suture strand” refers to a flexible line or flexible member of natural material, natural biological material, biomaterial, biomimetic materials, manmade material, or a combination of these either in a single structure, a composite structure, or a plurality of tissue structures that extend in parallel and/or may be woven or bonded together. In certain embodiments, a suture may be long and thin. In certain embodiments, a suture may be planar or may be elastic or inelastic. Examples of a suture include, but are not limited to, a thread, a suture, suture tape, a woven structure, a fibrous material, a cord, and/or any of these in combination with each other, and the like. The term “transverse” is used herein to mean to cross at an angle; i.e. not parallel. The term includes but is not limited to right angles. 95 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 1-12 depict an illustrative example of a suture anchor. The anchor 100 has an anchor body 102, a proximal member 104 joined to the anchor body 102 by a frangible connection 106 and a suture locking member 160. The frangible connection may include, for example, a thin wall (as shown), a perforated section, an intermediate material such as an adhesive, and/or other suitable frangible constructions. In the illustrative example of FIGS. 1-12, the anchor body 102 is generally cylindrical and has a sidewall 103 (FIG. 10) defining an exterior surface, a proximal end 108, a distal end 110, and a longitudinal axis 112 extending between the proximal and distal ends 108, 110. An interior longitudinal passageway 114 extends at least partway from the proximal end 108 toward the distal end 110. A proximal opening communicates with the longitudinal passageway nearer the proximal end 108 and a distal opening communicates with the longitudinal passageway nearer the distal end 110. In the illustrative embodiment of FIGS. 1-12, the proximal opening 116 communicates through the proximal end 108 of the anchor body 102 along the axis 112 with the passageway 114. The distal opening comprises a plurality of distal openings that communicate from the exterior surface of the anchor body 102 through the sidewall 103 to the passageway 114. 96 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the distal openings include a single superior opening 118 and two inferior openings 120, 122. The superior opening 118 is formed through the sidewall 103 and centered over the longitudinal axis of the anchor body. The two inferior openings 120, 122 are formed through the sidewall 103 opposite the superior opening 118 and spaced on either side of the longitudinal axis and separated by a dividing wall 124. All of the superior and inferior distal openings 118, 120, 122 are spaced proximally away from the distal end 110 of the anchor body. 97 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the anchor body 102 has a first exterior dimension 128, perpendicular to the longitudinal axis, over a first portion 130 of its exterior length 132; a second exterior dimension 134, perpendicular to the longitudinal axis, greater than the first dimension 128, over a second portion 136 of its exterior length 132; and a third exterior dimension 138, perpendicular to the longitudinal axis, greater than the second dimension 134, over a third portion 140 of its exterior length 132. For example, the first dimension 128 may be less than or equal to a radial dimension of a bone hole to ease alignment and initial insertion of the anchor body 102 into the bone hole. The second dimension 134 may be larger than the radial dimension of the bone hole to create a press fit of the second portion 136 within the bone hole to resist removal of the anchor body 102 from the bone hole. The third dimension 138 may create an even tighter press fit in the bone hole. The third portion 140 will require the greatest insertion force. By making the length of the third portion 140 relatively short, the total effort to insert the anchor body 102 will be lessened and the maximum insertion force will only be required to insert the relatively short third portion. The second and third portions 136, 140 may also have ribbed surfaces to further resist removal of the anchor body 102 from the bone hole. The spacing, or pitch, of the ribs may vary. For example, the second portion 136 may have ribs with relatively wider spacing for positioning in a relatively wide band of cancellous bone and the third portion 140 may have ribs with relatively narrower spacing for positioning in a relatively narrow band of cortical bone. 98 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the proximal member 104 is generally cylindrical and has a sidewall 150 (FIG. 10) defining an exterior surface, a proximal end 152, a distal end 154, and a longitudinal axis coaxial with the anchor body longitudinal axis 112 extending between the proximal and distal ends 152, 154. An axial through bore 156 extends through the proximal member 104 from the proximal end 152 to the distal end 154 and communicates with the longitudinal passageway 114 of the anchor body 102. At least one opening formed through the sidewall 150 of the proximal member 104 allows one or more sutures to be routed through the anchor body 102 without passing through the proximal end of the proximal member axial through bore 156. In the illustrative example of FIGS. 1-12, a first, superior “U”-shaped opening 158 is formed through the sidewall 150 near the distal end 154 and a second, inferior “U”-shaped opening 159 is formed through the sidewall 150 near the distal end 154 opposite the first opening 158. The “U”-shaped openings intersect the frangible connection 106. While the proximal member 104 and anchor body 102 are joined, the “U”-shaped openings 158, 159 each have a closed perimeter. When the proximal member 104 and anchor body 102 are separated at the frangible connection 106, the distal perimeter of each opening 158, 159 is removed such that separation of the proximal member 104 and anchor body 102 at the frangible connection 106 transforms the opening 158, 159 into open, “U”-shaped slots with the open side facing distally. The proximal member 104 includes an engagement portion for engaging a driver. In the illustrative example of FIGS. 1-12, the engagement portion includes an internal helical thread 161 operable to engage a driver in axial force transmitting relationship. 99 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the suture locking member 160 is in the form of an interference member operable to axially slide into the longitudinal passageway 114 of the anchor body 102 to secure a suture within the longitudinal passageway 114 by compressing the suture between the locking member 160 and the anchor body 102. In the illustrative example of FIGS. 1-12, the suture locking member 160 has an elongate cylindrical body 162 having a proximal end 164, a distal end 166, and a longitudinal axis 168 extending between the proximal and distal ends 164, 166. The body 162 has a dimension perpendicular to the longitudinal axis 168 less than or equal to the diameter of the anchor body passageway 114. Preferably the body 162 tapers distally. More preferably the body 162 tapers to a point 170. 100 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the suture locking member 160 is mounted in the axial through bore 156 of the proximal member 104 in axial sliding relationship so that it may be pressed out of the proximal member 104 and into the anchor body 102 to lock a suture in the anchor body 102. 101 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 1-12, the suture locking member 160 is retained in the proximal member 104 by a retainer 180 having an outer surface engaging the axial through bore 156 of the proximal member in axial sliding relationship and an axial aperture 182 receiving the locking member 160 in axial sliding relationship. The retainer 180 is also arranged to engage the anchor body 102 in axial force transmitting relationship. In the illustrative example of FIGS. 1-12, the retainer 180 is generally cylindrical and the axial aperture 182 extends through the retainer 180 from a proximal end 183 to a distal end 184. The outer diameter of the distal end 184 of the retainer 180 is larger than the diameter of the passageway 114 in the implant body 102. The distal end of the retainer 180 is operable to engage the proximal end of the implant body 102. The retainer 180 includes opposed superior and inferior “U”-shaped slots 186, 188 opening distally and aligning with the superior and inferior “U”-shaped openings 158, 159 in the proximal member 104 when the retainer 180 is seated in the proximal member 104. The retainer 180 includes a distal facing shoulder 190 operable to engage a proximal facing shoulder 192 formed in the through bore 156 of the proximal member to prevent the retainer from being completely expelled distally from the proximal member 104. 102 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 13 depicts an illustrative example of an inserter 200 for use with the suture anchor 100. FIGS. 14-19 depict the inserter 200 in use with the suture anchor 100. The inserter 200 extends from a proximal end 202 to a distal end 204. The inserter 200 has an elongated hollow shaft 206 and an elongated pushrod 208 mounted for axial translation within the hollow shaft. The shaft 206 includes an engagement feature at its distal end operable to engage the proximal member 104 of the suture anchor 100 in axial force transmitting relationship. In the illustrative example of FIG. 13, the shaft 206 includes an external helical thread 216 engageable with the internal helical thread 161 of the proximal member 104 (FIG. 14). The distal end of the pushrod 208 has a first portion 210 sized to engage the proximal end of the suture locking member 160 in axial force transmitting relationship while being operable to slide through the aperture 182 of the retainer 180. The distal end of the pushrod 208 has a second portion 212 sized to engage the proximal end of the retainer 180 in axial force transmitting relationship. The first portion 210 extends distally from the second portion 212. An advancement mechanism 214 at the proximal end of the inserter 200 is operable to advance the pushrod 208 distally relative to the shaft 206. For example, the advancement mechanism 214 may include any pushrod advancement mechanism such as those well known in the art for advancing plungers in syringe injectors, bone cement injectors, and other liquid and paste dispensers. The example of FIG. 13 illustrates such a mechanism including a trigger mounted to a base member in pivoting relationship. The pushrod is slidingly engaged with the base member and a pair of advancement plates. When the trigger is actuated, it presses on the advancement plates causing them to tilt and bind on the pushrod. Further actuation of the trigger advances the advancement plates and the pushrod distally together. When the trigger is released, a spring straightens the advancement plates and moves the advancement plates and the trigger proximally back to their initial positions. A ratchet mechanism prevents the pushrod from moving proximally. The ratchet mechanism includes ratchet teeth cut into the proximal end of the pushrod and a spring loaded ratchet pawl mounted in the base member at the rear of the pushrod. An actuator (not shown) may be actuated to disengage the ratchet pawl so that the pushrod may be moved proximally and reset to its initial position. 103 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 65 illustrates an embodiment of an interference member 770 that includes a drive recess 790. In one embodiment, the drive recess 790 is configured to accept a drive feature of a driver. For example, the drive recess 790 may be in the shape of a torx recess for receiving a corresponding torx drive feature of a driver. Alternatively, or in addition, the drive recess 790 may receive a driver having a distal end in the shape of a point and configured to move distally within the longitudinal passageway 714 and thereby press the interference member 770 into the anchor body 702. 148 Added by DJM 9 2021 9/2/21, 12:00 AM

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