Patent Publication Number: US-7214232-B2

Title: Graft fixation device

Description:
This is a Continuation-In-Part application of commonly assigned co-pending U.S. patent application Ser. No. 09/793,036 filed on Feb. 26, 2001 now U.S. Pat. No. 6,402,766 which is a Continuation-In-Part application of commonly-assigned, copending U.S. patent application Ser. No. 09/535,183 filed on Mar. 27, 2000 which is a Continuation-In-Part of commonly-assigned, copending patent application U.S. patent application Ser. No. 09/360,367 filed on Jul. 23, 1999 now U.S. Pat. No. 6,179,840, which are incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The field of art to which this invention relates is surgical fastening devices, in particular, surgical fastening devices for fixating tissue grafts to bone. 
     BACKGROUND OF THE INVENTION 
     The medical technology associated with tissue engineering has advanced at a rapid pace. In particular, it is now known to harvest cells from the human body, for example, chondrocytes and fibrochrondrocytes from the knee joint. These autologous cells are then cultured in a laboratory environment on a bioabsorbable matrix. The matrix will typically have a shape substantially similar to the tissue section which needs to be replaced. After a sufficient period of time in an appropriate culture medium at the proper environmental conditions, the harvested cells will grow on the matrix to form an implantable section of tissue having substantially the same physical configuration as the section of tissue which needs to be replaced in the patient. Such a tissue-engineered construct, consisting of cells on the matrix (or, alternatively, consisting of a matrix alone without cells), is then affixed to the bone site using conventionally known surgical fasteners including sutures, periosteal coverings, or fibrin glue. 
     The advantages of tissue engineering are many, not the least of which is, for example, that it is now possible to replace cartilage with living cartilage tissue. In addition, the likelihood of rejection of the tissue implant is minimized since the cartilage tissue which has been grown in-vitro is identical to the autologous cartilage of the patient. 
     Although existing matrix fixation devices are adequate for their intended use, there are also some disadvantages attendant with their use. First of all these fixation devices are generic in the sense that they are not specifically designed for matrix fixation to bone or soft tissue, but can be used for a variety of surgical procedures. Other disadvantages include the difficulty in using many of these devices in a minimally invasive arthroscopic procedure. Additional disadvantages include the difficulty and surgical challenge of harvesting a piece of periosteum for use as a periosteal flap, the significant patient morbidity associated with such harvesting, and the difficulty in suturing such a thin, compliant material to surrounding tissue. 
     Accordingly, there is a need in this art for novel fixation devices that will effectively affix a matrix of tissue-engineered tissue to a bone or other anchoring site so that the tissue may continue to grow and regenerate in the patient&#39;s body. 
     DISCLOSURE OF THE INVENTION 
     Therefore, it is an object of the present invention to provide a fixation device that effectively fixates a tissue-engineered matrix to a bone or other anchoring site, thereby enabling the implanted matrix to remain in place while the tissue continues to grow and regenerate. 
     It is a further object of the present invention to provide such a device for fixating a matrix to a bone site which is easily installed using an arthroscopic procedure or an open procedure. 
     It is yet a further object of the present invention to provide such a device for fixating a matrix to a bone site which does not require sutures or suture knot tying. 
     It is still yet a further object of the present invention to provide a surgical method for fixating a matrix utilizing such a device in a location within a patient&#39;s body. 
     Accordingly, a graft fixation device is disclosed. The graft fixation device has first and second implantation members. The members are elongated and preferably have a cylindrical configuration. The members also have distal ends, proximal ends, and longitudinal axes. There are longitudinal passages extending through the entire length of each implantation member. The members have outer surfaces. The implantation members are connected to each other by a rod member having first and second ends and a central section. The first end of the rod member extends from the proximal end of the first implantation member and the second end of the rod member extends from the proximal end of the second implantation member. The rod member is preferably relatively rigid and may be configured to have a variety of geometric shapes, for example, an inverted “U” shape. However, the rod member may also be flexible. The rod member maintains the implantation members at a relatively fixed distance from each other. The central section of the rod member is designed to engage a section of a tissue-engineered matrix implant. In a preferred embodiment, the implantation members have a series of ridges extending out from the outer surfaces of the implantation members to assist in preventing withdrawal from a bone site or other anchoring site after the implantation members are implanted into previously-created bore holes. 
     Yet another aspect of the present invention is a method of using the graft fixation device of the present invention to affix a matrix containing tissue-engineered tissue to a bone. 
     Still yet another aspect of the present invention is a graft fixation device combination which is the combination of a fixation device and an insertion device. The fixation device has a first implantation member. The implantation member has a longitudinal axis, a proximal end, a distal end, an outer surface, and a longitudinal passage therethrough. The fixation device also has a second implantation member. The second implantation member has a longitudinal axis, a proximal end, a distal end, an outer surface, and a longitudinal passage therethrough. Each implantation member has a proximal annular face on its proximal end surrounding the longitudinal passages. There is a connecting member connecting the first and second implantation members. The connecting member has a central section, a first end extending from the first implantation member and a second end extending from the second implantation member. There are a pair of insertion devices. Each insertion device is a member having a proximal end, a distal tapered end and a longitudinal passage therethrough. The distal end of each implantation member is in engagement with the proximal end of an insertion device. Optionally an insertion device is mounted to the distal end of an implantation member. 
     Yet another aspect of the present invention is a graft fixation device. The graft fixation device has first and second implantation members. The members are elongated and preferably have a cylindrical configuration. The members also have distal ends, proximal ends, and longitudinal axes. There are longitudinal passages extending through the entire length of each implantation member. The members have outer surfaces. The implantation members are connected to each other by a rod member having first and second ends and a central section. The first end of the rod member extends from the proximal end of the first implantation member and the second end of the rod member extends from the proximal end of the second implantation member. The rod member is preferably relatively rigid and may be configured to have a variety of geometric shapes, for example, an inverted “U” shape. However, the rod member may also be flexible. The rod member maintains the b The wing member facilitates such engagement. In a preferred embodiment, the implantation members have a series of ridges extending out from the outer surfaces of the implantation members to assist in preventing withdrawal from a bone site or other anchoring site after the implantation members are implanted into previously-created bore holes. 
     Yet another aspect of the present invention is a method of using the above-described graft fixation device having a laterally extending wing member to affix a matrix containing tissue-engineered tissue to a bone. 
     A further aspect of the present invention is a graft fixation device combination which is the combination of a fixation device and an insertion device. The fixation device has a first implantation member. The implantation member has a longitudinal axis, a proximal end, a distal end, an outer surface, and a longitudinal passage therethrough. The fixation device also has a second implantation member. The second implantation member has a longitudinal axis, a proximal end, a distal end, an outer surface, and a longitudinal passage therethrough. Each implantation member has a proximal annular face on its proximal end surrounding the longitudinal passages. There is a connecting rod member connecting the first and second implantation members. The connecting rod member has a central section, a first end extending from the first implantation member and a second end extending from the second implantation member. Extending laterally outward from the connecting member is at least one wing member. There are a pair of insertion devices. Each insertion device is a member having a proximal end, a distal tapered end and a longitudinal passage therethrough. The distal end of each implantation member is in engagement with the proximal end of an insertion device. Optionally an insertion device is mounted to the distal end of an implantation member. 
     Yet another aspect of the present invention is a method of using the above-described graft fixation device combination having a laterally extending wing member to affix a matrix containing tissue-engineered tissue to a bone. 
     A further aspect of the present invention is a graft fixation device. The graft fixation device has a first implantation member and a second implantation member. Each implantation member has an outer surface, a longitudinal axis, a proximal end and a distal end. Extending from, or mounted to, the distal end of each implantation member is a penetrating insertion member. The implantation members have a longitudinal passage, and proximal and distal openings in communication with the passage. The insertion members have outer surfaces, proximal ends, distal ends, and longitudinal axes. Each insertion member has a longitudinal passage and a proximal opening. The longitudinal passage has a distal closed, blind end. The proximal opening of each insertion member is in communication with the distal opening of the implantation member and the longitudinal passage of the insertion member. The implantation members are connected to each other by a retention member having first and second ends and a central section. The first end of the retention member extends from the proximal end of the first implantation member and the second end of the retention member extends from the proximal end of the second implantation member. The retention member is preferably relatively rigid, and may be configured to have a variety of geometric shapes, for example, an inverted “U” shape. However, the retention member may also be flexible. Optionally, extending laterally outward from the retention member is at least one wing member. The central section of the retention member with the optional wing member may engage a section of an implant such as a tissue-engineered matrix implant. 
     Yet another aspect of the present invention is a method of using the above-described graft fixation device to affix a matrix to a bone, e.g., to mount a matrix to a bone. 
     Still yet a further aspect of the present invention is a novel instrument which can be used in a surgical procedure to insert the above-described graft fixation device in bone. 
     These and other features and advantages of the present invention will become more apparent from the following description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a graft fixation device of the present invention. 
         FIG. 2  is a cross-sectional view of the graft fixation device of  FIG. 1  taken along view line  2 — 2 . 
         FIGS. 3-6  illustrate a surgical procedure for affixing a matrix to bone using the graft fixation device of the present invention. 
         FIG. 7  is an illustration of a graft fixation device of the present invention after the implantation members have been implanted in bore holes in bone illustrating the device affixing a matrix securely to the surface of a bone. 
         FIG. 8  is a cross-sectional view of the graft fixation device of  FIG. 7  implanted in bone, and taken along View Line  8 — 8 . 
         FIG. 9  is an alternative embodiment of a graft fixation device of the present invention having two connecting members. 
         FIG. 10  is a perspective view of an instrument useful for making bore holes in bone into which the implantable members of the graft fixation devices of the present invention may be emplaced. 
         FIG. 11  is a perspective view of an instrument useful for implanting the device of the present invention into bore holes made in bone. 
         FIG. 12  is a view of a tissue engineered matrix secured to a bone with several graft fixation devices of the present invention. 
         FIG. 13  is a perspective view of an alternate embodiment of a graft fixation device of the present invention. 
         FIG. 14  is a side view of the graft fixation device of FIG.  13 . 
         FIG. 15  is an end view of the graft fixation device of FIG.  14 . 
         FIG. 16  is a cross-sectional view of the graft fixation device of  FIG. 14 , taken along View-Line  16 — 16 . 
         FIG. 17  is a cross-sectional view of the tissue retention member of the graft fixation device of  FIG. 14 , taken along View-Line  17 — 17 . 
         FIG. 18  is a perspective view of an insertion member useful to insert a graft fixation member of the present invention. 
         FIG. 19  is an exploded perspective view of an insertion instrument, a graft fixation device, and two insertion members. 
         FIG. 20  is a side view of the distal end of the insertion instrument, a graft fixation device, and insertion members engaged in bone, prior to removal of the insertion device. 
         FIG. 21  is a cross-sectional view taken along View-Line  21 — 21  of  FIG. 20  of the prong of the insertion instrument, and a section of the retention member engaged in a longitudinal groove of the prong. 
         FIG. 22  is an exploded perspective view of the distal end of an insertion instrument of the present invention, illustrating a removable distal end assembly for creating bore holes in bone for receiving the fixation devices of the present invention, wherein the assembly has an end member and pins. 
         FIG. 23  is a cross-section of the assembly end member of  FIG. 22 , taken along View-Line  23 . 
         FIG. 24  is a perspective view of the assembly end of  FIG. 22 , completely assembled and ready for use. 
         FIG. 25  is a cross-sectional view of the end assembly of  FIG. 24 , taken along View-Line  25 — 25 . 
         FIG. 26  is an exploded perspective view of an insertion instrument of the present invention having a removable distal end assembly useful for inserting the graft retention members of the present invention into bore holes in a bone, having an end assembly member and two pins; when used with insertion members, the instrument can be used to emplace the fixation devices directly into bone without first forming bone bore holes. 
         FIG. 27  is a cross-sectional view of the end assembly member of FIG.  26 . 
         FIG. 28  is a perspective view of the distal end of the insertion instrument of  FIG. 26 , having the end assembly member and prongs fully assembled and mounted. 
         FIG. 29  is a cross-sectional view of the distal end of the insertion instrument of  FIG. 28  take along View-Line  29 — 29 . 
         FIG. 30  is a cross-sectional view of the instrument of  FIG. 29  taken along View-Line  30 — 30 . 
         FIG. 31  illustrates a fixation device of the present member having an insertion member molded into the distal end of each implantation member. 
         FIG. 32  is a cross-sectional view of the fixation device of FIG.  31 . 
         FIG. 33  is a perspective view of an alternate embodiment of a graft fixation device of the present invention having laterally extending wing members. 
         FIG. 34  is a view of a matrix secured to a bone with several graft fixation members of FIG.  33 . 
         FIG. 35  is a perspective view of yet another alternate embodiment of a graft fixation device of the present invention having laterally extending wing members. 
         FIG. 36  is a view of a matrix secured to a bone with several graft fixation members of FIG.  35 . 
         FIG. 37  is a perspective view of an alternate embodiment of a graft fixation device of the present invention; the implantation member has a longitudinal passage that extends partially therethrough. 
         FIG. 38  is a cross-sectional view of the graft fixation device of  FIG. 37  taken along View-Line  38 — 38 , also illustrating the mounting prongs of the insertion instrument. 
         FIG. 39  is a top view of a matrix secured to a bone with several of the graft fixation members of FIG.  37 . 
         FIG. 40  is a cross-sectional view of the retention member of the fastener of  FIG. 37  taken along View-Line  40 — 40 . 
         FIG. 41  is a cross-sectional view of the retention member of the fastener of  FIG. 37  taken along View-Line  41 — 41 . 
         FIG. 42  is an exploded perspective view of an insertion instrument useful to apply the fasteners of FIG.  37 . 
         FIG. 42A  is a partial magnified perspective view of the distal end of the shaft of the instrument of  FIG. 42  illustrating the mounting prongs. 
         FIG. 43  is a perspective view of the instrument of  FIG. 43  mounted to a slap hammer. 
         FIG. 44  is a cross-sectional view of the instrument of  FIG. 43  taken along View Line  44 — 44 . 
         FIG. 45  is a cross-sectional view of the instrument of  FIG. 44  taken along View Line  45 — 45 . 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The graft fixation devices of the present invention can be made from conventional bio-compatible materials, including absorbable and non-absorbable materials, as well as biodegradable materials. The non-absorbable materials which can be utilized include conventional biocompatible materials such as stainless steel, polyethylene, Teflon, Nitinol, non-absorbable polymers, other bio-compatible metals, ceramics, combinations thereof and the like. The absorbable materials which can be used to manufacture the graft fixation devices of the present invention will typically include those conventional bioabsorbable or bioresorbable materials known in this art which can be effectively molded or machined. The bio-absorbable and bio-resorbable materials include polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid, polygalactic acid, other known biocompatible bioabsorbable and bioresorbable polymers, ceramics, composites, combinations thereof and the like and equivalents thereof. 
     Referring now to  FIGS. 1-2 , a preferred embodiment of a graft fixation device  10  of the present invention is illustrated. The graft fixation device  10  is seen to have implantation members  20 . The implantation members  20  are seen to be elongated members, preferably having a substantially cylindrical shape. The members  20  may have other geometric shapes including conical, pyramidal, polygonal, cubic, spherical, etc. The implantation members  20  are seen to have distal ends  22  and proximal ends  24 . Each implantation member  20  is seen to have an outer surface  28  and a longitudinal axis  29 . Each member  20  is also seen to have longitudinal passage  35  extending therethrough. The implantation members  20  are also seen to have optional frustoconical ends  30 , and proximal endface surfaces  32 . Although it is preferred that endface surfaces  32  be flat, endface surface  32  may also be angled, concave, convex, etc. Endface surface  32  is seen to have central circular opening  36  in communication with passage  35 . Preferably, central opening  36  will have a circular cross-section, but it may have other geometric cross-sections as well including elliptical, polygonal, square, rectangular, combinations thereof and the like. Members  20  are also seen to have distal end face surfaces  37  having circular openings  38  in communication with passages  35 . As shown with the optional frustoconical end  30 , the annular end face surface  37  is of de minimis thickness around opening  38 , however this thickness would increase in the absence of a frustoconical end. Also seen to extend out from the surface  28  of member  20  are a series of optional projections  40  having tissue engagement edges  44 . Without the projections  40 , the surface  28  of the member  20  will be smooth. 
     The device  10  is seen to have graft retention member  50  connecting the implantation members  20 . Retention member  50  is seen to be a rod-like member having first end  52 , second end  54  and central section  55 . First end  52  is seen to extend from proximal endface surface  32  of the first member  20  while end  54  is seen to extend up from the proximal endface surface  32  of the other member  20 . The ends  54  and  52  of retention member  50  may also if desired extend from or be mounted to any section of outer surface  28 . The connecting member  50  is seen to be preferably bent or shaped into three segments including top segment  55  and leg segments  56 . The top segment  55  is seen to be substantially perpendicular to the leg segments  56 . Although it is preferred that connecting member  50  have an inverted “U” configuration, the connecting member  50  may have other geometric configurations including semicircular, arced, curved, triangular, polygonal, U-shaped, and the like and combinations thereof. The ends  52  and  54  of connecting member  50  may be permanently affixed to the implantation members  20 , or may be removably attached thereto in a conventional manner. Member  50  may be rigid or flexible. Member  50  will have a sufficient surface area to effectively retain a tissue-engineered matrix in place on a bone or other body surface. Preferably, connecting member  50  will have a circular cross-section, but may have other geometric cross-sections as well including elliptical, polygonal, square, rectangular, combinations thereof and the like. Member  50  may be rigid or flexible, and may have a single filamentary structure or have multiple interconnected filaments or members. 
     Referring now to  FIGS. 3-8 , the use of the graft fixation devices  10  of the present invention in a surgical procedure is illustrated. Referring first to  FIG. 3 , the initial step, prior to the installation of a matrix containing a tissue-engineered tissue using a graft fixation device  10  of the present invention, is to drill or “tap” two bore holes  200  into a bone  210 , for example, subchondral bone in the knee joint. The bore holes  200  are seen to be cylindrical holes having a bottom  208  and an open top  202  and side walls  205 . Optionally, the bore holes may be bone tunnels with a continuous passage and no bottom, or an open bottom. It is particularly preferred to tap the holes in the bone by using an instrument  400  as illustrated in  FIG. 10  which has a proximal section conventionally referred to in this art as a “slap hammer” section. The term “tapping” or “tap” as used herein is defined to mean a procedure wherein the distal pointed prongs  420  extending from the distal end  415  of the shaft  405  of instrument  400  are located over a bone site, and the proximal end  410  of instrument  400  is tapped or hit with slidable hammer handle  450  (of the “slap hammer”), which slides on shaft  460  between proximal end  410  and proximal stop  470 , to form the bone bore holes  200 . The distal end  465  of shaft  460  is connected to proximal end  411 . Proximal stop  470  is mounted to proximal end  467 . Hammer handle  450  is seen to have grasping section  451 , collars  455  and longitudinal passage  457 . Those skilled in the art will appreciate that a similar pointed instrument may be used to “tap” in the bore holes into bone, that is, any instrument having a nail-like distal end. In addition, although not preferred, one bone bore hole at a time may be “tapped” in. If the surgeon decides to drill the bore holes into bone, any conventional surgical drilling apparatus may be used. After the bore holes  200  are formed into the bone  210 , the matrix  220  containing tissue-engineering tissue is placed upon the bone surface  201  by the surgeon as seen in FIG.  4 . Next, the graft fixation device  10  is mounted on to the insertion instrument  250 . Insertion instrument  250 , as illustrated in  FIG. 11 , is seen to be an elongated rod  260  having a proximal end  262  and a distal end  264 . Mounted to the distal end  264  of the rod  260  is the depth stop  290 . The depth stop  290  is seen to be a substantially rectangular member which is mounted perpendicular to the longitudinal axis  251  of the rod  260 . Depth stop  290  is seen to have bottom  292 . Extending distally from the bottom  292  of plate member  290  is a pair of parallel, spaced-apart, mounting prongs  270 . The mounting prongs  270  are seen to be substantially rod-like members having distal pointed tips  277  and proximal ends  272 . The prongs  270  are seen to have first section  273  and distal section  275 . Section  273  is seen to have a greater cross-sectional dimension than distal section  275  such that the entire section  275  is insertable into passages  35  of members  20 , while proximal section  273  is not insertable therein. Instrument  250  is also seen to have a “slap hammer section” consisting of proximal shaft  300  extending from proximal end  262 , slidable hammer handle  320  (the “slap hammer”) which is slidable upon shaft  300  between proximal end  262 , and proximal stop  330 . Hammer handle member  320  is seen to have grasping section  325 , end collars  327  and longitudinal passage  329 . The graft fixation device  10  is mounted to the insertion instrument  250  by sliding the implantation members  20  onto the prongs  270  such that the distal sections  275  of members  270  are engaged within the longitudinal passages  35  of members  20  and distal points  277  protrude beyond the end of distal endface surfaces  37 . Then, as seen in  FIGS. 5 and 6 , the instrument  250  is manipulated such that the graft fixation device  10  is inserted through matrix  220  and into bone  210  by moving the implantation members  20  mounted on prongs  270  into the bore holes  200  such that the members  20  are engaged in the bore holes  200 , and such that the tissue engagement section  55  of the retention member  50  engages the matrix  220  such that the matrix  220  is firmly engaged against the surface  201  of the bone  210 . If desired, holes may be cut into matrix  220  prior to insertion of device  10 . Then, as seen in  FIG. 7 , the insertion instrument  250  is withdrawn proximally causing the prongs  270  to be withdrawn from the passages  35  of the implantation members  20 , thereby leaving the graft fixation device  10  engaged in the bone bore holes, and causing the matrix  220  to be maintained in engagement with the surface  201  of bone  210 . The “slap hammer” section of instrument  250  may assist in removal of the prongs. A cross-sectional view illustrating the device  10  engaged in bone  210  while maintaining the matrix  220  on bone surface  201  is seen in FIG.  8 . 
       FIG. 12  illustrates a matrix  220  mounted to bone surface  201  of bone  210  having multiple fixation devices of the present invention installed to secure the matrix  220 . The number, anatomical location and orientation of fixation devices  10  necessary to provide sufficiently effective fixation will vary with the size and type of implant or matrix, the type of tissue, the age of the patient, the size of the patient&#39;s defect, the size of the fixation devices, the material of construction of the fixation devices, the load on the tissue at the repair site, etc. 
     Those skilled in the art will appreciate that the size of the fixation devices of the present invention will vary in accordance with a number of variables including the specific design of the device, the materials of construction, the specific application for the devices, the type of surgical procedure, etc. Similarly, the size of the matrices fixated with these devices will similarly vary. The Figures which are part of this specification are merely schematic and illustrative of the device and method of the present invention; the actual dimensions of the devices and matrices may vary in practice. 
     The following example is illustrative of the principles and practice of the present invention although not limited thereto. 
     EXAMPLE 
     Six sheep were prepared for a surgical procedure using standard aseptic surgical techniques including the use of fully sterilized instruments and equipment, and conventional anesthesia procedures and protocols. The surgeon then created 7 mm diameter chondral (full thickness cartilage) defects on a weight-bearing area of the medial femoral condyle and in the trochlear groove in the right stifle (knee) in each of the six skeletally mature sheep. Defects were created using a specialized drill with a depth-stop to prevent subchondral bone exposure or penetration. The base surfaces of all the defects were then microfractured with a specialized micropick tool to provide access for cellular migration. The subjects were then separated into three groups of two subjects each:
         Group 1: defect filled with a collagen matrix, fixed with the graft fixation device of the present invention.   Group 2: defect filled with a collagen matrix, fixed with 9-0 absorbable Vicryl™ suture (interrupted stitch technique, approximately 12 strands per matrix).   Group 3: unfilled defect (control group).       

     Both defects in a given stifle received the same treatment or served as controls. 
     For the two sheep in Group 1, after a defect had been created and microfractured, a punch tool  400  was used to create the two requisite bore holes in the subchondral bone to receive one graft fixation device of the present invention. Only one polydioxanone device (4 mm tip-to-tip distance) was used to attach each matrix. To create the bore holes, the punch tool was centered in the defect, oriented in the sagittal plane, and hit or “tapped” with a slap hammer repeatedly until it penetrated several millimeters into the subchondral bone. Next, a 7 mm diameter circular collagen matrix, saturated with saline, was placed in the defect and then blotted dry to remove excess saline. When the inserter tool  250  was loaded with the graft fixation device  10  of the present invention, the device and inserter tool were centered above the matrix and oriented in the sagittal plane. The surgeon then located the previously created bore holes by slowly advancing the distal tips of the inserter through the matrix. Once the surgeon located the holes with the inserter tips, a hammer was used to fully advance the inserter tool (and implantation members  20  of the fixation device  10 ) through the matrix and into the subchondral bone. The inserter tool had a depth stop to prevent the implantation members  20  from being inserted too deeply, thereby assuring the proper placement of the implantation members through the matrix. The insertion was completed when the connecting retention member between the two implantation members initially started to compress the collagen matrix, thereby indicating secure fixation with the underlying subchondral bone. After the two defects in a given stifle had each been repaired with a matrix and fixation device, the stifle was closed and the sheep was allowed to recover. It was noted by the surgeon that it took approximately one minute to attach a matrix with a fixation device of the present invention (Group 1), versus approximately 15 minutes to attach a matrix with suture alone and the requisite suture manipulation and knot tying (Group 2). 
     Two weeks after the surgeries were completed, the knee joints were surgically opened for examination. Gross macroscopic assessment of the joints demonstrated that all four matrices held by the graft fixation device of the present invention were fully intact. However, all four matrices held by sutures alone were only partially intact with, on average, approximately 30% of the sutures broken on any given matrix. 
     Another embodiment of the fixation device of the present invention having multiple retention members is seen in FIG.  9 . The device  300  is seen to have a pair of implantation members  310 . The implantation members  310  are substantially cylindrical members having longitudinal axis  311 , distal ends  314  and proximal ends  312 . Each implantation member  310  is seen to have a longitudinal passage  320 . The members  310  are seen to have a distal frustoconical end  330 , outer surface  350 , and ridges  355  extending outward from surface  350 . The members  310  are seen to be connected by a pair of retention members  340 , having first and second ends  342  and  344  respectively. 
     Yet another embodiment of a fixation device of the present invention is illustrated in  FIGS. 13-17 . The graft fixation device  500  is seen to have implantation members  520 . The implantation members  520  are seen to be elongated members, preferably having a substantially cylindrical shape. The members  520  may have other geometric shapes including conical, pyramidal, polygonal, cubic, spherical, etc. The implantation members  520  are seen to have distal ends  522  and proximal ends  524 . Each implantation member  520  is seen to have an outer surface  528  and a longitudinal axis  529 . Each member  520  is also seen to have longitudinal passage  535  extending therethrough. The implantation members  520  are also seen to have optional frustoconical ends  530 , and proximal end face surfaces  532 . Although it is preferred that endface surfaces  532  be flat, endface surfaces  532  may also be angled, concave, convex, etc. Each endface surface  532  is seen to have central circular opening  536  in communication with passage  535 . Preferably, central opening  536  will have a circular cross-section, but it may have other geometric cross-sections as well including elliptical, polygonal, square, rectangular, combinations thereof and the like. Members  520  are also seen to have distal end face surfaces  537  having circular openings  538  in communication with passages  535 . Preferably, endface surfaces  537  have a sharp edge configuration, but may also have various widths with a rounded or flat configuration. As shown with the optional frustoconical end  530 , the annular end face surface  537  is of de minimis thickness around opening  538 , however this thickness would typically increase in the absence of a frustoconical end. However, although not preferred, even with a frustoconical, the end surface  537  could have various widths as previously mentioned. Also seen to extend out from the surface  528  of member  520  are a series of optional projections  540  having tissue engagement edges  544 . Without the projections  540 , the surface  528  of the member  520  will be smooth, however, it will be appreciated that surface  528  could be rough, or could have a variety of conventional projections such as cones, hemispheres, rods, hooks, etc., and the like and equivalents thereof. 
     The device  500  is seen to have graft retention member  550  connecting the implantation members  520 . Retention member  550  is seen to be a band-like member preferably having an oval cross-section. The retention member  550  is seen to have first end  552 , second end  554  and central section  555 . First end  552  is seen to extend up from proximal endface surface  532  of the first member  520  while end  554  is seen to extend up from the proximal endface surface  532  of the other member  520 . A section  557  of end  552  is seen to extend out from section  539  of surface  528 , while section  558  of second end  554  is also seen to extend out from a section  539  of surface  528 . The ends  554  and  552  of retention member  550  may if desired extend from or be mounted to any section of outer surface  528 . The connecting member  550  is seen to be preferably bent or shaped into three segments including top segment  555  and leg segments  556 . The top segment  555  is seen to an arc shaped member, and the leg segments  56  are seen to be preferably perpendicular to surfaces  532 . Although it is preferred that connecting member  550  have an inverted “U” configuration, the connecting member  50  may have other geometric configurations including semicircular, arced, curved, triangular, polygonal, V-shaped, and the like and combinations thereof. The ends  552  and  554  of connecting member  550  may be permanently affixed to the implantation members  520 , or may be removably attached thereto in a variety of conventional manners, for example, a ball and socket joint, a plug joint, etc. Member  550  may be rigid or flexible. Member  550  will have a sufficient surface area to effectively retain a tissue-engineered matrix in place on a bone or other body surface. Preferably, connecting member  550  will have an oval cross-section, but may have other geometric cross-sections as well including circular, elliptical, polygonal, square, rectangular, combinations thereof and the like. Member  550  may be rigid or flexible, and may have a single filamentary structure or have multiple interconnected filaments or members. 
     An embodiment of graft fixation device  500  having lateral wing members  580  is seen in  FIGS. 35 and 36 . Referring to  FIG. 35 , the device  500  is seen to have wing members  580  extending laterally from the central section  555  of the connecting member (or graft retention member)  550 . The wing members  580  are preferably elongated members having a distal end  584  and a proximal end  582 . Extending from the distal end  584  is a rounded nose section  590 . If desired nose section  590  may have other geometric configurations including conical, pyramidal, and the like, etc. The wing members  580  are seen to have outer surface  586 . As seen in  FIG. 35 , the wing members  580  are seen to have a circular cross-section, tapering from a maximum dimension at proximal end  582 . There is seen to be a transition section  592  between the proximal end  582  and the top  555  of retention member  550 . If desired, the diameter may be constant along the length of the wing member  580 . The wing members  580  may have other cross-sectional configurations as well including oval, square, rectangular, triangular, polygonal, curved, combinations thereof and the like. The length of the wing members  580  is sufficient to provide effective retention of an implant graft. If desired, although not preferred, the wing members  580  may short or of medium length, rather than elongated. Similarly, the width or diameter of the wing members will vary to provide sufficiently effective graft retention. Although it is preferred to have two opposed wing members  580  extending laterally from the retention member  550 , a single wing member  580  may be used, or a plurality of wing members  580  may be used with device  500 . The retention devices  500  having wing members  580  are illustrated implanted in bone and securing a graft matrix implant in FIG.  36 . The method of implanting a device having wing members  580  is substantially similar, and having the same steps, to implanting a device  500  without wing members  580  as described and illustrated previously herein. As seen in  FIG. 36 , at least a portion of surface  586  engages the top of the matrix  220  on bone  210 . 
     Another aspect of the present invention is a distal insertion member (device) useful with the fixation devices of the present invention. As seen in  FIG. 18 , the insertion device  600  is seen to be a substantially cylindrical member having proximal end  610  and distal end  620 . Proximal end  610  is seen to have a flat end surface  612 . Frustoconical end section  630  is seen to extend distally from distal end  620 , although device  600  may have other configurations as well. If desired, distal end  620  can have any tapered or curved configuration, but it is preferred that it have a frustoconical end section extending therefrom. The frustoconical end section  630  is seen to have outer surface  632  and distal tip  640 . The member  600  is also seen to have exterior surface  650 . Extending through member  600  is the longitudinal passage  660  having first circular opening  665  in communication therewith, and second circular opening  667  in tip  640  in communication therewith. The insertion members  600  are used in combination with the fixation members of the present invention to engage the fixation member in bone simultaneously with tapping the bore holes into bone, thereby eliminating the need for a separate step to form the bore holes prior to inserting the fixation member. 
     Referring to  FIGS. 19-21 , the previously mentioned combination of an insertion member  600  and a fixation member  500  is illustrated. Initially, a fixation member  500  is mounted to prongs  700  extending from the distal end  415  of the shaft  405  of instrument  400 . Each prong  700  is seen to have first cylindrical section  710  extending from the distal end  415  of the shaft  405 . Each cylindrical section  710  is seen to have proximal end  711  and distal end  712 , and receiving grooves  715 . Extending from the distal end  712  of each first section  710  is the central pin section  720 . Central pin section  720  is seen to have proximal end  722  and distal end  724 . Extending distally from distal end  724  of central pin section  720  is the distal pin member  730 . Distal pin member  730  is seen to have proximal end  732  and distal pointed end  734 . 
     If desired, the insertion member  600  may be molded into or affixed to the distal end of an implantation member  520 , thereby forming a unitary structure as seen in FIG.  31  and FIG.  32 . In addition, the insertion member  600  may be mounted to the distal end of an implantation member  520  in a conventional manner by gluing, cementing, mechanical fastening, friction fit and the like and equivalents thereof. 
     The combination of a unitary implantation device  500  having wing members  580  as previously described and an insertion member  600  is illustrated in  FIGS. 33 and 34 . This combination with wing members  580  securing a matrix  220  to bone  210  is seen in FIG.  34 . If desired, although not shown, the insertion members  600  may be separate from the insertion device  500  having wing members  580 . The method of inserting this combination having wing members  580  is substantially identical to that described and illustrated herein. 
     The combination of the insertion members  600  and fixation members, such as fixation member  500  of the present invention, are used to affix a matrix to bone in the following manner. Initially, the implantation members  520  of a fixation device  500  are placed upon prongs  700  of an instrument  400  such that the leg members  556  are at least partially engaged in grooves  715  in first section  710  (see FIG.  21 ), and, intermediate sections  720  of pin members  700  are engaged in passages  535  of implantation members  520 , while pin members  730  extend out from the distal ends of the implantation members  520 . Then, insertion members  600  are placed over the pin members  730 , such that the pin members  730  are engaged in passages  660 , and such that the pointed piercing ends  734  extend beyond the distal ends  640  of the insertion member  660 . Then, the tool  400  and the assembly consisting of fixation device  500  and insertion member  600  is placed over a tissue matrix  220  placed upon a bone  210 . The piercing points are then pressed through matrix  220  to contact the surface  211  of bone  210 . A slap-hammer section of instrument  400  is engaged to drive the piercing points  734 , insertion members  600  and implantation members  520  into the bone  210  as bore holes  200  are formed in the bone. The instrument  400  is then withdrawn proximately, thereby removing the intermediate sections  720  of prongs  700  from the implantation members  520  and the pin members  730  from the insertion members  600 , leaving the insertion members  600  and the implantation members  520  securely in the bone (as seen in FIG.  20 ). This completes the affixation of the matrix  220  to the bone  210  using a single step, wherein the bore holes in the bone are formed simultaneously as insertion members  600  and fixation device  500  are emplaced in the bone. 
     It is particularly preferred to use conventional remote visualization surgical procedures when inserting the fixation devices of the present invention. For example, inserting a scope through a trocar cannula into the joint or body cavity, while insufflating the joint or body cavity. 
     The insertion members  600  will typically be made from a strong, hard, bioabsorbable material such that they can be driven into bone without fracturing or breaking. Examples of the types of materials which can be used to make the insertion member  600  include polylactic acid, polyglycolic acid, tricalcium phosphate, calcium phosphate, tetracalcium phosphate and hydroxyapatite, and any copolymers, mixtures or blends thereof. Although not preferred, it is possible to make the insertion members from a conventional biocompatible material which is not bioabsorbable or biodegradable, such as titanium, stainless steel, ceramics, Nitinol and the like and equivalents thereof. The insertion member  600  assists in forming the bore holes  200  while protecting the implantation members  520 . 
       FIGS. 22-23  illustrate a disposable distal end assembly  800  for an instrument  400  of the present invention. When using the disposable assembly  800 , it is preferable that the distal end  415  of the shaft  405  of instrument  400  have screw threads  418 , although other conventional detachable mounts may be used, for example a bayonet-type mount, locking levers and tabs, male and female mating sections, etc. As seen in  FIGS. 22-25 , the assembly  800  consists of housing  810  having proximal end  811  and distal end  817 . Housing  810  is seen to have hollow cavity  815  therein. Cavity  815  is seen to be in communication with proximal end opening  812  and distal end openings  820 . Member  810  is seen to have outer surface  822 . Outer surface  822  is preferably knurled to facilitate the grasping and turning of the housing  810 . Housing  810  is further seen to have distal end surface  825 . The outer surface  822  is seen to have a tapered section  823  that tapers toward end face  825 . Contained within cavity  815 , on inner surface  818  are the screw threads  819 . Assembly  800  is also seen to have driving pin members  830 . Each driving pin member  830  is seen to have proximal disk member  832  mounted to proximal end  831 , shaft section  834  and distal pointed end  838 . Surrounding each opening  820  on the interior of the member  810  are the annular recesses  840 . The assembly  800  is mounted to the distal end  415  of the instrument  400  in the following manner. The pins  830  are inserted into cavity  815  and through openings  820  such that the shafts  834  and distal piercing points  838  extend through end face  825 , and the disk members  832  are contained within the annular recesses  840 . Then, the housing  810  is mounted upon the threads of distal end  415  such that threads  418  engage mating threads  819 , and screwed further such that the proximal end surfaces  833  of the disk members  832  are in contact with the distal end face  416  of distal end  415 . After use in a surgical procedure, the assembly  800  is removed and discarded. A new sterile assembly  800  is utilized with a cleaned and sterilized instrument  400  for each new procedure. 
     Referring now to  FIGS. 26-30 , a disposable end assembly  900  for mounting to an insertion instrument  250  is illustrated. The insertion member  250  is seen to have distal end  264 , having endface  265  and screw threads  266 . The assembly  900  is seen to have housing  950 . Housing  950  has proximal end  952  and distal end  956  and exterior surface  954 . Extending from distal end  956  is the plate member  960 . Plate member  960  is seen to have distal surface  962 . The exterior surface  954  is seen to have optional knurling and distal tapered section  957  tapering into plate member  960 . Housing  950  is seen to have internal cavity  955 . Housing  950  is also seen to have proximal opening  951  in communication with cavity  955  and distal openings  970  also in communication therewith. Housing  950  is seen to have internal screw threads  959  extending from internal surface  958 . Also contained within the interior of housing  950  in the distal end  956  is the recessed groove  980 . Assembly  900  is mounted to the distal end  264  of instrument  250  in the following manner. Pins  910  are inserted through cavity  950  and openings  970  such that proximal members  922  are engaged in groove  980 . Sections  920  and  930  of pins  910  extend through openings  970 . Sections  920  are seen to have grooves  925 . Then, the housing  950  is screwed on to distal end  264  such that the threads  266  engage the mating internal threads  959  of housing  950 . The housing is tightened until the distal end surface  265  of the distal end  264  engages the top surfaces  923  of members  922 . After a surgical procedure, the assembly  900  is removed from instrument  250  and discarded. A new sterile assembly  900  is utilized with a cleaned and sterilized instrument  250  for each new procedure. 
     Another alternate embodiment of the graft fixation members of the present invention is illustrated in  FIGS. 37-41 . An embodiment of a graft fixation device  1000  having optional lateral wing members  1080  is seen. Referring to  FIGS. 37 and 38 , the device  1000  is seen to have wing members  1080  extending laterally from the central section  1055  of the connecting member (or graft retention member)  1050 . Retention member  1050  is seen to be a band-like member preferably having an oval cross-section (See FIGS.  40  and  41 ). The retention member  1050  is seen to have first end section  1052 , second end section  1054  and central section  1055 . First end  1052  is seen to extend up from proximal endface surface  1112  of the first member  1100  while end  1054  is seen to extend up from the proximal endface surface  1112  of the other member  1100 . A section  1057  of end  1052  is seen to extend out from a section of outer surface  1114 , while a section  1058  of second end  1054  is also seen to extend out from a section of outer surface  1114 . The ends  1054  and  1052  of retention member  1050  may if desired extend from or be mounted to any section of outer surface  1114 , or extend solely from proximal end surfaces  1112 . The connecting or retention member  1050  is seen to be preferably bent or shaped into three segments including top segment or central section  1055  and leg segments or end sections  1056 . Although it is preferred that connecting member  1050  have an inverted “U” configuration, the connecting member  1050  may have other geometric configurations including semicircular, arced, curved, triangular, polygonal, V-shaped, and the like and combinations thereof. The ends  1052  and  1054  of connecting member  1050  may be permanently affixed to the implantation members  1110 , or may be removably attached thereto in a variety of conventional manners, for example, a ball and socket joint, a plug joint, etc. Member  1050  may be rigid or flexible. Member  1050  will have a sufficient surface area to effectively retain a tissue-engineered matrix in place on a bone or other body surface. Preferably, connecting member  1050  will have an oval cross-section, but may have other geometric cross-sections as well including circular, elliptical, polygonal, square, rectangular, combinations thereof and the like. Member  1050  may be rigid or flexible, segmented, or may have a single filamentary structure or have multiple interconnected filaments or members. 
     The optional and preferred wing members  1080  are preferably elongated members having a distal end  1084  and a proximal end  1082  Extending from the distal end  1084  is a rounded nose section  1090 . If desired nose section  1090  may have other geometric configurations including conical, pyramidal, and the like, etc. The wing members  1080  are seen to have outer surface  1086 . The wing members  1080  preferably have an elliptical or circular cross-section, tapering from a maximum dimension at proximal end  1082 . There is seen to be a transition section  1092  between the proximal end  1082  and the central section  1055  of retention member  1050 . If desired, the diameter may be constant along the length of the wing member  1080 . The wing members  1080  may have other cross-sectional configurations as well including oval, square, rectangular, triangular, polygonal, curved, combinations thereof and the like. The length of the wing members  1080  is sufficient to provide effective retention of an implant graft and maintain contact of the implant against a bone, for example, a bone surface. If desired, although not preferred, the wing members  1080  may be of short or medium length, rather than elongated. Similarly, the width or diameter of the wing members will vary to provide sufficiently effective graft or matrix retention and contact of the graft or matrix with the bone. Although it is preferred to have two opposed wing members  1080  extending laterally from the retention member  1050 , a single wing member  1080  may be used, or a plurality of wing members  1080  may be used with device  1000 . 
     The members  1100  are seen to have a top section and a bottom section. The top section consists of implantation member  1110  and a lower section consists of penetrating insertion member  1150 . The upper implantation member  1110  is seen to be a substantially cylindrical member having a proximal end  1120  and a distal end  1130 . Preferably the distal end has a frustoconical configuration. Extending through implantation member section  1110  is the passage  1140 . Passage  1140  is seen to be an elongated passage. An opening  1141  in proximal endface  1112  of implantation member  1110  is seen to be in communication with the passage  1140 . Distal opening  1145  is also seen to communicate with passage  1140 . The implantation member section  1110  is seen to have outer side surface  1114 . Extending radially outward from outer surface  1114  is at least one engagement member  1117  having edge  1118  forming a ridge. 
     The penetrating insertion member sections  1150  are seen to have proximal ends  1160  and distal ends  1170 . The distal end  1170  preferably has a distal penetrating tip  1175 . Tip  1175  may be blunt or sharp. Each penetrating insertion section  1150  is seen to be a substantially conically shaped member having proximal end face  1165  having opening  1191  therein. The insertion member sections  1150  are further seen to have longitudinal passages  1190  having blind end walls  1195 . Passage  1190  is seen to be in communication with opening  1191  which in turn is in communication with opening  1145 , and accordingly passages  1140  and  1190  are in communication with each other. If desired, although not preferred, passage  1190  can continue through the length of insertion member  1150 , with a constant or smaller or tapering diameter, and blind end wall  1195  could be replaced with a flange having an opening or a member protruding radially inward into passage  1190  to engage the distal end of a mounting pin of an insertion instrument. 
     The graft fixation devices  1000  are made in a conventional manner preferably from bioabsorbable materials as previously mentioned for other embodiments of the fasteners disclosed herein. It is particularly preferred to co-mold the implantation member section and the insertion member section, although other conventional means of affixing the implantation member and the insertion may be used including mechanical fastening, welding, adhesives, glues, and the like and combinations thereof. The penetrating insertion member sections  1150  will typically be made from a strong, hard, bioabsorbable material such that they can be driven into bone without fracturing or breaking. Examples of the types of materials which can be used to make the penetrating insertion members  1150  include polylactic acid, polyglycolic acid, tricalcium phosphate, calcium phosphate, tetracalcium phosphate and hydroxyapatite, and any copolymers, mixtures or blends thereof and equivalents thereof. Although not preferred, it is possible to make the insertion members from a conventional biocompatible material which is not bioabsorbable or biodegradable, such as titanium, stainless steel, ceramics, Nitinol nickel-titanium alloy, polysulfone, acetal and the like and equivalents and combinations thereof. The penetrating insertion members  1150  can be made from conventional processes, including machining, molding, combinations and equivalents thereof and the like. The penetrating insertion members  1150  assist in forming the implantation or bore holes  200  while protecting the implantation member sections  1110 . The implantation member sections  1110  can be made from conventional bio-compatible materials, including absorbable and non-absorbable materials, as well as biodegradable materials. The non-absorbable materials which can be utilized include conventional biocompatible materials such as stainless steel, polyethylene, Teflon, Nitinol, non-absorbable polymers, other bio-compatible metals, ceramics, combinations thereof and the like. The absorbable materials which can be used to manufacture the implantation members  1110  will typically include those conventional bioabsorbable or bioresorbable materials known in this art which can be effectively molded or machined. The bio-absorbable and bio-resorbable materials include polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid, polygalactic acid, other known biocompatible bioabsorbable and bioresorbable polymers, ceramics, composites, combinations thereof and the like and equivalents thereof. If desired the implantation members  1110  and the insertion members  1150  can be made from the same material. 
     The graft fixation devices  1000  having wing members  1080  are illustrated implanted in bone  205  and securing a graft matrix implant  220  to the surface  210  of the bone  205  in FIG.  39 . 
     An instrument  1400  and an instrument assembly  1600  useful for implanting graft fixation devices  1000  is illustrated in  FIGS. 42-45 . The instrument  1400  is seen to have shaft  1410  having proximal end  1415  and distal end  1418 . Extending proximally from proximal end surface  1416  of proximal end  1415  is threaded rod connector  1417 . The shaft  1410  is seen to have a tapered end section  1430  extending from distal end  1418 . Extending laterally (radially) out from shaft  1410  toward proximal end  1415  are the guide pins  1420 . Extending out distally from tapered end  1430  are the mounting pins or mounting members  1450  having proximal ends  1452  and distal ends  1457  having distal flat end faces  1458 . The sleeve member  1470  is seen to be a tubular member having distal end  1477  and proximal end  1472 . The member  1470  has inner or longitudinal passage  1480  in communication with distal opening  1485  and proximal opening  1482 . The member  1470  has outer surface outer surface  1475 , and a proximal handle section surface  1476  extending therefrom. The sleeve member  1470  is seen to have a plurality of openings  1490  extending therethrough in the distal end  1477  in communication with inner passage  1480 . The openings  1490  act as windows so that the interior of sleeve member  1470  may be viewed adjacent thereto. The sleeve member  1470  is seen to have opposed longitudinal slots  1492  extending therethrough in the proximal end  1472 . The sleeve member  1470  is concentrically and slidably mounted over shaft  1410  such that the pins  1420  are contained within slots  1492 , and mounting pins  1450  are contained within passage  1480  adjacent to distal end  1477  of sleeve member  1470 , or extending out from distal end  1477  of sleeve member  1470 . 
     An assembled insertion instrument assembly  1600  is seen in  FIG. 43 , having the sleeve member  1470  in the maximum proximal position to expose the mounting members  1450 . The insertion instrument assembly  1600  is seen to have insertion instrument  1400  with an optional conventional slap hammer assembly  1530  mounted to the proximal end  1415  of shaft  1410 . The slap hammer assembly  1530  is seen to have a tapered connecting section  1540  having distal end  1541  and proximal end  1546 . Distal end  1541  is seen to have threaded cavity  1542  extending therein, and proximal end  1546  is seen to have threaded cavity  1547  extending therein. The slap hammer assembly  1530  is seen to have support rod  1550  having proximal end flange  1555  and distal threaded end  1558 . The assembly has handle member  1560  slidably mounted on rod  1550 . Handle member  1560  is seen to have longitudinal passage  1568 , proximal flange member  1562  and distal flange member  1564 . The threaded end  1558  of support rod  1550  is engaged in threaded cavity  1547  of tapered connecting section  1540 . The threaded rod connector  1417  of shaft  1410  is similarly engaged in threaded cavity  1542  of connecting section  1540 . The insertion instrument  1400  may be used without slap hammer assembly to insert graft fixation devices of the present invention. For example, the proximal end  1415  of shaft  1410  may be connected to other conventional force transmitting devices, or the proximal end  1415  may be hammered directly by the surgeon using a conventional orthopedic hammer. 
     A method of implanting a graft fixation device  1000 , having optional wing members  1080 , using an insertion instrument assembly  1600  is described as follows. It should be noted that although it is preferred to insert the graft fixation devices  1000  directly into bone using the insertion instrument assembly  1600  without pre-drilling or otherwise pre-creating bore holes in bone, the device  1000  can also be utilized to affix a matrix to bone where the bore holes are pre-drilled or otherwise pre-created. 
     In using the graft fixation device  1000  of the present invention having optional wing members  1080  with insertion instrument assembly  1600 , an incision is made in a conventional manner to access the patient&#39;s bone (via a conventional arthroscopic or open procedure) where it is desired to implant a matrix. After the matrix  220  is positioned on the surface  210  of bone  205  as seen in  FIG. 39 , a device  1000  is mounted to the mounting pins  1450  of insertion instrument  1400  of insertion assembly  1600 . Next the sleeve member  1470  is moved distally to cover the insertion device  1000 , thereby protecting the device  1000 , and the surgeon locates the device at the surgical site using insertion instrument assembly  1600 . Next, the surgeon slides the sleeve  1470  proximally to uncover the insertion device  1000 . Then, the distal end of penetrating insertion member  1150  is contacted with the top  221  of the matrix  220 . The optional slap hammer assembly  1530  is manipulated to drive the penetrating insertion member  1150  and the implantation member  1100  into the bone  205 . This causes the central section  1055  of retention member  1050  and the lateral wing member  1080  to engage the matrix  220  and substantially cause the bottom surface  222  of the matrix  220  to engage the surface  210  of the bone  205 . Multiple fixation devices  1000  are inserted in the same manner into the matrix  220  in a spatial configuration sufficient to effectively affix or mount the matrix  220  to the bone  205 . During insertion with the insertion instrument assembly  1600  having insertion instrument  1400  and slap hammer assembly  1530 , the distal flat end faces  1458  of pins  1450  contact end walls  1195  of passage  1190  causing a transfer of force from the mounting pins  1450  to penetrating insertion members  1150  thereby driving the device the penetrating insertion members  1150  and the implantation members  1110  into the bone  205 . 
     The fixation devices of the present invention and the combination of the fixation devices with insertion members, and methods of using such devices and combinations, of the present invention have many advantages. The advantages include providing a fast and routine way to fixate a matrix of tissue engineered tissue or other tissue. The fixation devices and combination, because they eliminate the need for suture knot tying, can be utilized in arthroscopic surgical procedures that require a minimum of surgical incisions and thus greatly reduce patient morbidity. In addition, the fixation devices and combination have been demonstrated to provide excellent matrix fixation without damaging the surrounding normal cartilaginous tissue, unlike the conventional fixation of chondral defect matrices with traditional suture that must be passed through (and thus damage) the surrounding tissue. 
     Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the claimed invention.