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     Metal 3DP Hybrid Suture Anchor for Osteoporosis
           position, have been used for anchors that fail to provide   the feasibility of the novel HSA for failure strength and
           optimal  fixation  after  insertion [1,2,4] . Improving anchor   bone growth, respectively.
           design to increase the retention between the anchor and
           osteoporotic bone can be an alternative option .    2. Materials and methods
                                                 [6]
               Numerous anchor constructs are available  to    2.1. Design of the novel HSA and instruments
           maximize  retention  on  the  anchor-bone  interface  and
           avoid  early  suture  anchor  fixation  failure.  The  failure   We designed a screw-type anchor, which is 16  mm
           strength of the suture anchor is known to be affected by   in length, 5.5  mm in diameter, and dual-thread  with
           its design, including fixation type, anchor material, and   micro-threads  in the upper compressive taper head
           suture type [7-9] . Anchors can be divided into screw- and   (4-mm double-starts with 1.05-mm pitch) of the anchor
           impaction-type  devices . Screw-type  anchors have   for distributing stress because of supplementary contact
                               [2]
           threads that are advanced into the bone and show higher   between the micro-threads and cortical bone to improve
           failure strength than smaller non-screw anchors designed   mechanical  retention  (Figure  1). Macro  single-threads
           for glenoid repairs because screws  impart increased   with 2.10-mm pitch was designed in the remaining part
           surface  area  for  more  holding  strength  and  efficiency   of the anchor. Two 0.8-mm diameter holes that allow the
           compared with impaction-type devices [2,7,10,11] .  No. 2 suture to pass through were placed symmetrically
               Bioabsorbable and poly(ether-ether-ketone) (PEEK)   on both sides of the head. The round and undercut thread
           suture  anchors are  rapidly  evolving  and  supplanting   near the suture hole for suture protection and square hole
           metallic  anchors  in  rotator  cuff  surgery.  However,   at the anchor center for matching the instrument was also
           although bioabsorbable anchors are absorbed with time   considered at the compressive taper head. The anchor tip
           after surgery, they do not provide suture stretching force .   was designed to enable self-drilling and positioning when
                                                         [2]
           Although the wing structure  deployed  with the PEEK   inserted into the bone (Figure 1).
           impaction-type  anchor  subcortically  provides secure   The HSA is designed with a symmetric  wing
           fixation  to  the  bone ,  pushout  strength  is  significantly   mechanism  on  both  sides  that  can  be  clamped  to
                            [7]
           greater  for implants with porous titanium  than PEEK,   surrounding bone tissue to provide the anchor with a
           with titanium being the only material showing adequate   better holding power and failure strength between anchor
           bone growth and proximity inside implant threads [9,12] .  and bone when required. The wing mechanism needs to
               The design concept of integrating the advantage of   be designed as axially symmetrical to allow the internal
           metal  screw-type anchor and deploying  wing structure   fixation screw to push the wings with an average force
           subcortically  can improve retention between the metal   after insertion. However, our anchor only designed to
           anchor and the bone to increase anchor pullout strength.   be symmetrical  with two blades because the torsional
           However, this novel design, with a complicated structure,   strength of the anchor entity might be too weak when over
           may  encounter  processing  difficulties  that  traditional   two blades were designed for the anchor. For unfolding
           metal cutting processes cannot overcome. Recently, laser   both wings, a screw is used to push the convex surface
           powder bed fusion (LPBF), as an important laser-based   at  the anchor  centric  hole  when inserting  the  2-mm
           additive  manufacturing  (AM) technique,  also noted as   diameter internal screw into the anchor (Figure 1). The
           three-dimensional  (3D) printing technique  for metal   barb function can be used when both wings are expanded
           components,  provides  an  opportunity  to  manufacture   and  the  anchor  is  pulled  out  through  the  sutures.  The
           components with complex geometries in the aerospace,   space created when the wings are open helped the bone
           automotive, and medical applications [13-15] . The 3D printing   to grow inward; three holes with 600-μm diameter were
           technique is well established for building complicated 3D   also created on both sides of the anchor for bone ingrowth
           constructions from computer-aided design (CAD) models   (Figure 1).
           for controllable of precise dimension about 20 μm and   The instruments with HSA must be used in
           has great  potential  to  solve  the  problems  of creating  a   conjunction with arthroscopy and divided into the outer
           porous (lattice) on a dense titanium and porous titanium   sleeve instrument and central hexagonal driver. The main
           body for enhancing bone growth .                    function of the outer sleeve is to implant the anchor into
                                      [6]
               In this study, we deployed  a novel hybrid suture   the bone and using a square connection to strengthen
           anchor (HSA) with wing structure mechanism contained   the locking force. The outer sleeve instrument was also
           outer dual-threaded profile and inner hole threads with   designed to be hollow to enable  the central  hexagonal
           convex surface that complex geometry can be fabricated   driver to pass through to lock the internal  screw such
           by titanium 3D printing technology. The wing mechanism   that the anchor wings can be unfolded. The implantation
           can be opened by an internal milling screw according to   process involved  inserting  the  suture  anchor  into  the
           the state of the osteoporotic bone. In vitro static/dynamic   bone tissue by the outer sleeve to a suitable position and
           testing and animal experiments were performed to verify   then  rotating  the central  hexagonal driver  to drive  the
           162                         International Journal of Bioprinting (2022)–Volume 8, Issue 4
     	
