Abstract:
Surgical instruments and methods aimed at the proper placement and installation of textile-based orthopedic implants. More specifically, the surgical instruments include a flexible template, insertion instrument and multi-pronged awl. The flexible template may be formed of a combination of rigid and flexible materials and is deformable to match the contour of the target anatomy for subsequent placement of a textile-based orthopedic implant. The insertion instrument has a handle and a template end used for holding the flexible template and textile-based implant. The template end has one or apertures with hollow cylindrical extensions for holding the flexible template or textile-based implant and one or more cutout regions for better visualization and affixation of fixation screws. An awl is also provided with one or more prongs to initiate channels for the fixation screws. A method of implanting a textile-based orthopedic implant is also disclosed.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    The present application is a non-provisional application claiming the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/219,745, filed Jun. 23, 2009, and entitled “ Methods and Instrumentation for Orthopedic Surgery,” the complete disclosure of which is hereby incorporated by reference in its entirety as if set forth fully herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    I. Field of the Invention 
         [0003]    The present invention relates to templates, instruments, and methods generally aimed at surgery and, more particularly, to templates, instruments, and methods aimed at the efficient and accurate installation of flexible implants. 
         [0004]    II. Discussion of the Prior Art 
         [0005]    Rigid plate implants have been used for many years to support bone fractures, reconstruct orthopedic structure across damaged ligaments, and to provide stability between fused spinal vertebrae. Rigid plate implants are usually affixed via fixation elements, such as bone screws, to nearby osseous tissues in order to restrict motion and to provide support during and after healing. 
         [0006]    Although in many cases complete joint immobilization is preferred, in certain instances surgeons prefer to allow for retention of limited mobility across the affected joint during the course of post-operative fusion. Furthermore, in instances where the plate must conform to a bone, such as to protect a fracture or to support fused vertebrae, it can be challenging to manually shape the standard rigid surgical plate to custom fit the desired area. 
         [0007]    Flexible textile-based orthopedic implants are therefore an alternative to rigid implants. The compliant nature of the textile-based implant provides the required flexibility to support a range of physiological movements, as opposed to a static fusion surgery. One example of a textile-based plate implant is described in commonly owned and co-pending U.S. patent application Ser. No. 12/274,345 entitled “Textile-Based Plate Implant and Related Methods”, filed Nov. 19, 2008, the entire contents of which are hereby incorporated by reference into this disclosure as if set forth fully herein. Textile-based orthopedic implants are suitable for use in many surgical applications, including but not limited to spinal fusion surgery. 
         [0008]    When using sterile textile implants, it is important to first accurately determine which size or shape of implant to use for a given application before removing the implant from its sterile packaging. Trial size templates are often used during surgery to confirm which textile implant is an appropriate size and shape for the surgical application. Because the textile implants are flexible, a typical rigid trial size template mimicking the size and shape of the textile-based implant may not be appropriate to determine which implant is appropriate. A rigid trial size template cannot conform to the patient&#39;s anatomy as a flexible implant can. It may also be difficult to pass a rigid trial size template through the operative corridor to the target site, where a flexible textile implant would easily pass if folded or bent. 
         [0009]    In addition to the flexible trial size template, an inserter instrument with various end sizes corresponding to the sizes of textile implants can be used to confirm which implant is an appropriate size and shape for the surgical application. The inserter instrument can also be used to guide an awl to make channels through the implant apertures for bone screws or other attachment means. The inserter instrument may be used to hold the flexible textile-based plate implant in place while the screws or other attachment means are installed. 
       SUMMARY OF THE INVENTION 
       [0010]    The templates and instruments describe herein may be constructed in any number of suitable fashions without departing from the scope of the present invention. The templates and instruments of the present invention are illustrated herein for use within the lumbar spine, but are suitable for use in other regions of the spine (e.g. cervical, thoracic), as well as for the repair of other bones and tissues containing fractures or needing reinforcement. 
         [0011]    The templates are configured in various sizes analogous to the different sizes of textile-based orthopedic implants. The templates may be formed of a combination of rigid and flexible materials, or primarily of flexible materials. A variety of materials may be used to form the flexible portion of the templates, including but not limited to elastomer (e.g. silicone rubber), hydrogel, plastic mesh, plastic constructs, injectable fluids, and curable fluids. A variety of materials may be used to form the rigid portion of the templates, including but not limited to plastics and metals. 
         [0012]    The template includes a first lateral end and a second lateral end, each having one or more apertures. Apertures on the trial size template correspond to screw apertures on the textile-based orthopedic implant where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. Lateral ends are composed of a rigid material. The template has a first coplanar side and a second coplanar side. A flexible section connects the lateral ends along an axis X extending between the coplanar sides. The flexible section enables the template to bend within the flexible section along the axis X. 
         [0013]    According to another embodiment, the template includes a first lateral end and a second lateral end, each having one or more apertures. Apertures on the trial size template correspond to screw apertures on the textile-based orthopedic implant where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. Lateral ends are composed of a rigid material. The template has a first coplanar side and a second coplanar side. A flexible section connects the coplanar sides along an axis Y extending between the lateral ends. The flexible section enables the template to bend within the flexible section along the axis Y in either direction. 
         [0014]    According to another embodiment, the template includes a first lateral end and a second lateral end, each having one or more apertures. Apertures on the trial size template correspond to screw apertures on the textile-based orthopedic implant where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. Lateral ends are composed of a rigid material. The template has a first coplanar side and a second coplanar side. A flexible section connects the coplanar sides along an axis Y extending between the lateral ends. The flexible section enables the template to bend within the flexible section along the axis Y in either direction. An additional flexible section also connects the lateral ends along an axis X extending between the coplanar sides. The flexible section enables the template to bend within the flexible section along the X axis in either direction. 
         [0015]    According to another embodiment, the template includes lateral ends having apertures. Apertures on the trial size template correspond to apertures on the textile-based orthopedic implant where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. Lateral ends are composed of a rigid material. The template has a flexible hinge connecting the rigid lateral ends. The flexible hinge extends between a first coplanar side and a second coplanar side, along an axis X. The flexible hinge is made of a rigid material. The flexible hinge enables the template to bend at the flexible hinge along the axis X in either direction. 
         [0016]    According to another embodiment, the template includes lateral ends having one or more apertures. Apertures on the trial size template correspond to apertures on the textile-based orthopedic implant where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. The template has a body connecting the lateral ends. The body and lateral ends are comprised entirely of or primarily of flexible material, enabling the template to bend linearly or torsionally in any direction as needed, similar to the flexibility of a textile-based orthopedic implant (not shown). Template may preferably be composed of a translucent or transparent polymer, which would increase intraoperative visibility. 
         [0017]    In order to use the flexible trial size template, the template is introduced into a surgical site through use of any of a variety of suitable surgical instruments having the capability to engage the template, such as forceps. The template is capable of being used in minimally invasive surgical procedures, needing only a relatively small operative corridor for insertion when folded along the flexible section. After creating an operative corridor and preparing the surgical site using techniques commonly known and used in the art, the template is mated to an insertion device and advanced through the operative corridor toward the target surgical site. The template is positioned in a configuration suitable for the eventual installation of the textile-based orthopedic implant. If the selected template is not of an appropriate size for the desired target site, the template is removed from the surgical site and a different template is selected for trial sizing. 
         [0018]    When the appropriate size of implant is determined, the template is removed from the surgical site and a corresponding textile-based orthopedic implant is selected and removed from its sterile packaging. The implant is then placed in the target site and affixed using techniques commonly known in the art. 
         [0019]    The inserter instrument includes a handle, a template end, and an extension connecting the handle and template end. The inserter instrument is provided in a variety of template end sizes, analogous in size to the various sizes of textile-based orthopedic implants. The extension is of a length appropriate for insertion into a surgical operative corridor. The extension may be configured to be of an adjustable longitudinal length by telescoping or other means. The extension may include an elbow connector comprising an angle A to orient the template end in an ergonomic position relative to the handle. The elbow connector may be made of a flexible yet resistant material that allows the user to manipulate the elbow connector into a desired position, where it will remain until manipulated further. 
         [0020]    The template end of the inserter instrument has a first lateral end and a second lateral end. Lateral ends include one or more screw apertures. At least one of lateral ends may have a cutout in place of a screw aperture. In one embodiment, both of lateral ends each have a cutout. One or more of the screw apertures may have one or more adjacent visualization apertures. Visualization apertures may follow a semi-circular path around the screw aperture, but other shapes permitting visualization of the underlying osseous tissues are contemplated. 
         [0021]    The template end has a distal surface. The distal surface has hollow cylindrical extensions around the screw apertures, protruding in a distal direction. The cylindrical extensions are positioned to correspond to screw apertures on the textile-based orthopedic implant. The cylindrical extensions are configured to fit within the corresponding screw apertures of the textile-based orthopedic implant to hold the implant in place during insertion. The apertures allow the user to confirm where on the osseous tissues the bone screws or other attachment means are to be affixed. 
         [0022]    In order to use the inserter instrument, a textile-based orthopedic implant is placed on the distal side of the appropriately sized template end of the inserter instrument. The screw apertures of the implant are placed around the cylindrical extensions. The inserter instrument and implant are then advanced into the surgical corridor to the target site. The inserter instrument is used to orient the implant in a desired configuration for affixation. The one or more screw apertures on the implant that is exposed by the cutout is affixed first in the manner described below, or other means commonly known in the art. The cutout is large enough to permit the screw to be externally driven by a tool, if needed. The inserter instrument holds the implant in place while screws are affixed through the apertures at the cutouts, preventing the implant from rotating with the screw as it is tightened. Next, the inserter instrument is removed from the implant and the remaining screws are placed through the implant. 
         [0023]    The two-tipped awl has a handle for manipulating the awl. The handle is configured on its proximal end to withstand an impact by a hammer or other driving device. Distal to the handle is a connector extending between the handle and a bridge. The bridge is generally perpendicular to the handle and connector. At each lateral end of the bridge is an elbow connector. Each elbow connector is situated between the bridge and a prong. The prongs extending from each elbow connector are coplanar with the handle and connector. The prongs are positioned to correspond to the location of the screw apertures of the trial size templates, the screw apertures of the implant inserter instrument, and the screw apertures of textile-based orthopedic implants. Each prong terminates distally in a pointed tip. The width of the pointed tips is slightly less than or equal to the width of the bone screws or other means of attachment to be used. The pointed tips will enter the osseous tissue when the handle is hammered until the desired depth is reached, creating a channel for the placement of the bone screws. 
         [0024]    The three-tipped awl has a handle for manipulating the awl. The handle is configured on its proximal end to withstand an impact by a hammer or other driving device. Distal to the handle is a connector extending between the handle and a bridge. The bridge is generally perpendicular to the handle and connector. At each lateral end of the bridge is an elbow connector. Each elbow connector is situated between the bridge and a prong. The three-tipped awl has an additional prong extending from the center of the bridge. The prongs are coplanar with the handle and connector. The prongs are positioned to correspond to the location of screw apertures of textile-based orthopedic implants. Each prong terminates distally in a pointed tip. The width of the pointed tips is slightly less than or equal to the width of the bone screws or other means of attachment to be used. The pointed tips will enter the osseous tissue when the handle is hammered until the desired depth is reached, creating a channel for the placement of the bone screws. 
         [0025]    In order to use the awl, first the inserter instrument with a textile-based orthopedic implant attached, or the textile-based orthopedic implant, is placed on the surgical target in the desired position. Next, the awl is advanced through the surgical corridor to the target site. The pointed tips are positioned within the screw apertures of the implant. A hammer is used to impact the handle end that is protruding from the surgical corridor. The hammer is used until the pointed tips enter into the osseous tissue to the desired depth. The awl is then removed from the surgical corridor, and bone screws or other attachment means are affixed using the holes made by the pointed tips as path guides. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    The invention will be more fully understood from the following detailed descriptions taken in conjunction with the accompanying drawings, in which: 
           [0027]      FIG. 1  is a perspective view of an example of a flexible textile-based orthopedic implant. 
           [0028]      FIG. 2  is a perspective view of an example of a flexible trial size template according to one embodiment of the present invention; 
           [0029]      FIG. 3  is a perspective view of an example of a flexible trial size template according to another embodiment of the present invention; 
           [0030]      FIG. 4  is a perspective view of an example of a flexible trial size template, according to another embodiment of the present invention; 
           [0031]      FIG. 5  is a perspective view of an example of a flexible trial size template, according to another embodiment of the present invention; 
           [0032]      FIG. 6  is a perspective view of an example of a flexible trial size template, according to another embodiment of the present invention; 
           [0033]      FIG. 7  is a perspective view of an example of an inserter instrument, according to one embodiment of the present invention; 
           [0034]      FIG. 8  is a perspective view of an example of a template end of an inserter instrument, according to another embodiment of the present invention; 
           [0035]      FIG. 9  is a bottom view of the inserter instrument of  FIG. 7 ; 
           [0036]      FIG. 10  is a perspective view of an example of an awl instrument, according to one embodiment of the present invention; and 
           [0037]      FIG. 11  is a perspective view of an example of an awl instrument, according to another embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0038]    Illustrative embodiments of the invention are described below for the purposes of understanding the principles of the invention. No limitation of the scope of the invention is therefore intended. In the interest of clarity, not all features of an actual implementation are described in this specification. It will be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers&#39; specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The invention disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination. 
         [0039]      FIG. 1  illustrates an example of a flexible textile-based orthopedic implant  5  suitable for attachment to a pair of bone segments, for example a pair of vertebral bodies. One example of a textile-based plate implant is described in commonly owned and co-pending U.S. patent application Ser. No. 12/274,345 entitled “Textile-Based Plate Implant and Related Methods”, filed Nov. 19, 2008, the entire contents of which are hereby incorporated by reference into this disclosure as if set forth fully herein. The implant  5  includes a body  6  and a plurality of fixation apertures  7 . Each fixation aperture  7  is configured to receive a fixation element (e.g. bone screw) to secure the implant  5  to the bony structures. The implant  5  shown by example includes four fixation apertures  7 , however the specific number of fixation apertures  7  may vary according to the type of implant  5  used and the needs of the surgeon. 
         [0040]      FIGS. 2-6  illustrate several examples of a flexible trial size template according to the present invention. The templates may be provided in various sizes analogous to the different sizes of textile-based orthopedic implants. The templates may be formed of a combination of rigid and flexible materials, or primarily of flexible materials. Any suitable material may be used to form the flexible portion of the templates, including but not limited to elastomer (e.g. silicone rubber), hydrogel, plastic mesh, plastic constructs, injectable fluids, curable fluids, and fibrous textile materials. The degree of flexibility provided is more than mere non-rigidity, such that the implant is capable of being substantially twisted or doubled over. Any suitable material may be used to form the rigid portion of the templates, including but not limited to plastics and metals. 
         [0041]      FIG. 2  illustrates an example of a flexible trial size template  10  according to one embodiment of the present invention. The template  10  includes a first end portion  12  and a second end portion  14 , each having one or more apertures  16 . Apertures  16  on the trial size template  10  correspond to fixation apertures  7  on the textile-based orthopedic implant  5  of  FIG. 1 , where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. In all of the examples described herein, the number of apertures  16  is four, however it should be understood that the number of apertures  16  provided within the template  10  corresponds with the number of fixation apertures  7  of the textile-based implant  5 , and therefore the template  10  may be provided with more or less than four apertures  16  without departing from the scope of the present invention. First and second end portions  12 ,  14  are composed of a rigid material, for example plastics and/or metal. The template  10  further has a first side  13  and a second side  15 . A flexible section  18  is located between first and second end portions  12 ,  14  and connects the first and second end portions  12 ,  14  along an axis X extending between the sides  13 ,  15 . The flexible section  18  enables the template to bend within the flexible section  18  along the axis X. 
         [0042]      FIG. 3  illustrates an example of a flexible trial size template  20 , according to another embodiment of the present invention. For simplicity of disclosure, elements of the various template examples described herein below that are substantially similar to elements of template  10  have been assigned the same callout numbers. The template  20  includes a first end portion  22  and a second end portion  24 , each having one or more apertures  16 . Apertures  16  on the trial size template  20  correspond to screw apertures  7  on the textile-based orthopedic implant  5  ( FIG. 1 ). The template  20  has a first side portion  23  and a second side portion  25 . A flexible section  28  connects the side portions  23 ,  25  along an axis Y extending longitudinally through the template  20 . The flexible section  28  enables the template to bend within the flexible section  28  along the axis Y in either direction. 
         [0043]      FIG. 4  illustrates an example of a flexible trial size template  30 , according to yet another embodiment of the present invention. The template  30  is essentially divided into four zones of rigid material  36 ,  37 ,  38 ,  39  by the flexible section  31 , which bisects the template  30  along two axes (X, Y). Each zone  36 ,  37 ,  38 ,  39  has one or more apertures  16 . Apertures  16  on the trial size template  30  correspond to screw apertures  7  on the textile-based orthopedic implant ( FIG. 1 ). The template  30  has a first side  33  and a second side  35  and a first lateral end  32  and a second lateral end  34 . Flexible section  31  connects the sides  33 ,  35  along an axis Y extending between the lateral ends  32 ,  34 . The flexible section  31  enables the template to bend within the flexible section  31  along the axis Y in either direction. Flexible section  31  also connects the lateral ends  32 ,  34  along an axis X extending between the sides  33 ,  35 . The flexible section  31  enables the template to bend within the flexible section  31  along the X axis in either direction. 
         [0044]      FIG. 5  illustrates an example of a flexible trial size template  40 , according to another embodiment of the present invention. The template  40  includes lateral ends  42 ,  44  having apertures  16 . Apertures  16  on the trial size template  40  correspond to apertures on the textile-based orthopedic implant  5  ( FIG. 1 ) where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. Lateral ends  42 ,  44  are composed of a rigid material. The template  40  has a hinge  41  connecting the rigid lateral ends  42 ,  44 . The hinge  41  extends between a first side  43  and a second side  45 , along an axis X. The hinge  41  is made of a rigid material. The hinge  41  enables the template to bend at the hinge  41  along the axis X in either direction. 
         [0045]      FIG. 6  illustrates a flexible trial size template  50 , according to one embodiment of the present invention. The template  50  includes lateral ends  52 ,  54  having one or more apertures  16 . Apertures  16  on the trial size template  50  correspond to apertures on the textile-based orthopedic implant  5  ( FIG. 1 ) where bone screws or other attachment means may be placed through to affix the implant to the osseous tissue. The template  50  has a body  51  extending between the lateral ends  52 ,  54  and the sides  53 ,  55 . The body  51  and lateral ends  52 ,  54  are comprised entirely of or primarily of flexible material, enabling the template  50  to bend linearly or torsionally in any direction as needed, similar to the flexibility of the textile-based orthopedic implant  5 . Template  50  may preferably be composed of a translucent or transparent polymer, which would increase intraoperative visibility. 
         [0046]    In order to use the flexible trial size template  10 ,  20 ,  30 ,  40 , and  50 , shown in  FIGS. 2-6 , the template is introduced into a surgical site through use of any of a variety of suitable surgical instruments having the capability to engage the template, such as forceps. The template is capable of being used in minimally invasive surgical procedures, needing only a relatively small operative corridor for insertion when folded along the flexible section. After creating an operative corridor and preparing the surgical site using techniques commonly known and used in the art, the template is mated to an insertion device and advanced through the operative corridor toward the target surgical site. The template is positioned in a configuration suitable for the eventual installation of the textile-based orthopedic implant. If the selected template is not of an appropriate size for the desired target site, the template is removed from the surgical site and a different template is selected for trial sizing. 
         [0047]    When the appropriate size of implant is determined, the template is removed from the surgical site and a corresponding textile-based orthopedic implant is selected and removed from its sterile packaging. The implant is then placed in the target site and affixed using techniques commonly known in the art. 
         [0048]      FIGS. 7-9  illustrate an example of an inserter instrument  60  according to one embodiment of the present invention. The inserter instrument  60  includes a handle  62 , a template end  64 , and an extension  66  connecting the handle  62  and template end  64 , as illustrated in  FIG. 7 . The inserter instrument  60  may be provided in a variety of template end  64  sizes, analogous in size to the various sizes of textile-based orthopedic implants  5  ( FIG. 1 ). The extension  66  is of a length appropriate for insertion into a surgical operative corridor. The extension  66  may be configured to be of an adjustable longitudinal length by telescoping or other means, as illustrated by the arrows in  FIG. 7 . The extension may include an elbow connector  68  comprising an angle A to orient the template end  64  in an ergonomic position relative to the handle  62 . The elbow connector  68  may be made of a flexible yet resistant material that allows the user to manipulate the elbow connector  68  into a desired position, where it will remain until manipulated further. 
         [0049]      FIGS. 8-9  further illustrate the template end  64  of the inserter instrument  60 . The template end  64  has a first lateral end  72  and a second lateral end  73 . Lateral ends  72 ,  73  include one or more screw apertures  70 . At least one of lateral ends  72 ,  73  may have a cutout  74  in place of a screw aperture  70 . In one embodiment, illustrated in  FIG. 8 , both lateral ends  72 ,  73  have a cutout  74 . The cutouts  74  serve multiple purposes. First, it allows for an inserter with a smaller overall profile such that it can fit through smaller operative corridors. Second, it reduces the material required so that costs may be reduced. Another benefit of the cutout  74  is that it increases visibility of the surgical target site by the surgeon during the procedure. One or more of the screw apertures  70  may have one or more adjacent visualization apertures  76 . Visualization apertures  76  may follow a semi-circular path around the screw aperture  70 , as illustrated in  FIGS. 7-9 , but other shapes permitting visualization of the underlying osseous tissues are contemplated. 
         [0050]    The template end  64  has a distal surface  80 , as shown in  FIG. 9 . The distal surface side  80  has hollow cylindrical extensions  82  around the screw apertures  70 , protruding in a distal direction. The cylindrical extensions  82  are positioned to correspond to screw apertures  7  on the textile-based orthopedic implant  5  ( FIG. 1 ). The cylindrical extensions  82  are configured to fit within the corresponding screw apertures of the textile-based orthopedic implant to hold the implant in place during insertion. The apertures  70  allow the user to confirm where on the osseous tissues the bone screws or other attachment means are to be affixed. 
         [0051]    In order to use the inserter instrument  60 , a textile-based orthopedic implant is placed on the distal side of the appropriately sized template end  64  of the inserter instrument  60 . The screw apertures  7  of the implant  5  are placed around the cylindrical extensions  82 . The inserter instrument  60  and implant  5  are then advanced into the surgical corridor to the target site. The inserter instrument  60  is used to orient the implant  5  in a desired configuration for affixation. The one or more screw apertures  7  on the implant that is exposed by the cutout  74  is affixed first in the manner described below, or other means commonly known in the art. The cutout  74  is large enough to permit the screw to be externally driven by a tool, if needed. The inserter instrument  60  holds the implant in place while screws are affixed through the apertures  7  at the cutouts  74 , preventing the implant from rotating with the screw as it is tightened. Next, the inserter instrument  60  is removed from the implant and the remaining screws are placed through the implant. 
         [0052]      FIG. 10  illustrates an example of a two-tipped awl  90  of the present invention. The awl  90  has a handle  92  for manipulating the awl  90 . The handle  92  is configured on its proximal end (not shown) to withstand an impact by a hammer (for example a mallet or slap hammer) or other driving device. Distal to the handle  92  is a connector  93  extending between the handle  92  and a bridge  98 . The bridge  98  is generally perpendicular to the handle  92  and connector  93 . At each lateral end of the bridge  98  is an elbow connector  94 . Each elbow connector  94  is situated between the bridge  98  and a prong  96 . The prongs  96  extending from each elbow connector  94  are coplanar with the handle  92  and connector  93 . The prongs  96  are positioned to correspond to the location of the screw apertures  16  of the trial size templates  10 ,  20 ,  30 ,  40 , and  50 , the screw apertures  70  of the implant inserter instrument  60 , and the screw apertures  7  of textile-based orthopedic implant  5 . Each prong  96  terminates distally in a pointed tip  99 . The width of the pointed tips  99  is slightly less than or equal to the width of the bone screws or other means of attachment to be used. The pointed tips  99  will enter the osseous tissue when the handle  92  is hammered until the desired depth is reached, creating a channel for the placement of the bone screws. 
         [0053]      FIG. 11  illustrates an example of a three-tipped awl  100  of the present invention. For simplicity of disclosure, elements of awl  100  that are substantially similar to elements of awl  90  have been assigned the same callout numbers. The awl  100  has a handle  92  for manipulating the awl  100 . The handle  92  is configured on its proximal end (not shown) to withstand an impact by a hammer or other driving device. Distal to the handle  92  is a connector  93  extending between the handle and a bridge  98 . The bridge  98  is generally perpendicular to the handle  92  and connector  93 . At each lateral end of the bridge  98  is an elbow connector  94 . Each elbow connector  94  is situated between the bridge  98  and a prong  96 . The three-tipped awl  100  has an additional prong  96  extending from the center of the bridge  98 . The prongs  96  are coplanar with the handle  92  and connector  93 . The prongs  96  are positioned to correspond to the location of screw apertures  7  of textile-based orthopedic implant  5  ( FIG. 1 ). Each prong  96  terminates distally in a pointed tip  99 . The width of the pointed tips  99  is slightly less than or equal to the width of the bone screws or other means of attachment to be used. The pointed tips  99  will enter the osseous tissue when the handle  92  is hammered until the desired depth is reached, creating a channel for the placement of the bone screws. 
         [0054]    In order to use the awls  90 ,  100 , first the inserter instrument  60  with a textile-based orthopedic implant  5  attached, or the textile-based orthopedic implant  5 , is placed on the surgical target in the desired position. Next, the awl is advanced through the surgical corridor to the target site. The pointed tips  99  are positioned within the screw apertures of the implant. A hammer is used to impact the handle end that is protruding from the surgical corridor. The hammer is used until the pointed tips  99  enter into the osseous tissue to the desired depth. The awl  90 ,  100  is then removed from the surgical corridor, and bone screws or other attachment means are affixed using the holes made by the pointed tips  99  as path guides. 
         [0055]    While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined herein.