Spinal spacer

Description: TECHNICAL FIELD [Detailed description of the invention]

Spine spacer Field of invention The present invention relates to spacers, configurations, instruments and methods of fixing joints. Book In certain applications of the invention, spacers are a joint combination with components of bone formation. Including bone transplantation in. Background of the invention Spinal fusion is structural deformity, traumatic instability, degenerative instability, and Prevents painful spinal movement due to instability after excision and stabilizes the spinal column in case of injury It is desirable to give sex. Fusion or arthrodesis is an adjacent motor segment It is achieved by forming a bone-like bridge between the two. This is continuous Anterior between the vertebrae, posterior during the lateral process, thin layer of the vertebrae or other vertebrae Achieved within the intervertebral disc between. Bone-like bridges, or fusions, are living organisms by the body when the skeleton is damaged. Occurs scientifically. This regular bone treatment reproduces the damaged state of the spinal column along the fusion site And can induce fusion into the normal spinal segment and then treat the bone Used by doctors to. Successful fusion is bone formation or bone-producing cells, Requires proper blood supply, adequate inflammatory response, and proper local bone preparation .. This biological environment usually exposes the canal, spongy bone, and external cortical bone. Provided by surgical osteopathy by peeling and removing. Fusion or joint fixation procedures treat anomoly, including the intervertebral disc Is executed for. The intervertebral disc placed between the end plates of the adjacent vertebrae is the dorsal It stabilizes the bones, distributes the force between the vertebral bones, and cushions the body of the spinal column. normal The intervertebral disc is surrounded and closed by an outer fibrous ring called the annular fiber. Contains a semi-gelatinous component, nuclear pulposus. Healthy damage In the spine that has not received the annular fiber, the nuclear porposus has disk space Prevents it from protruding outward. The intervertebral disc metastasizes and is damaged by trauma, disease, and aging. Breakage of cyclic fibers Is a condition in which the nuclear porposus protrudes into the spinal canal and is called a hernia or destruction disc. Make it into a state. Extruded nuclear cells push the spinal nerves, causing nerve damage, pain, paralysis, Causes muscle weakness and paralysis. Also, the intervertebral disc is in a normal deterioration process or disease. Therefore, it also deteriorates. When the disc becomes dehydrated, the height of the disc decreases and the spine It makes it unstable, slows movement, and causes pain. The only relief from the symptoms of these conditions is discectomy. Yes, that is, surgically part or all of the intervertebral disc followed by fusion of adjacent spines Remove. By removing this damaged or unhealthy disc, the disc Can be contracted. Due to the contraction of the intervertebral disc voids, in addition to severe pain, the back Abnormal bone structure, arthritis and nerve damage occur early. Discek Pain relief through discectomy and arthrodesis is an empty disc It requires the preservation of gaps and the uniform fusion of affected motor segments. Bone transplantation prevents the disc voids from contracting and spans the disc voids Promotes fusion of adjacent spines. According to conventional techniques, bone materials are generally It is simply placed between adjacent vertebrae on the posterior flank of the spinal column. The spinal column is on the affected spinal column It is stabilized by such a plate or rod. When fusion occurs, Segmen Equipment used to maintain stability is no longer needed and becomes a permanent foreign body Ta. In addition, a rod or plate is implanted to stabilize the level during fusion. The surgical procedure required is redundant and complex. Therefore, a more optimal solution to the stability of the excised disc void is preferred. Or melt the spine between each end plate without the need for anterior and posterior plates To understand. Damaged vertebrae at least until complete arthrodesis is achieved Used to replace discs and maintain the stability of the vertebral voids between adjacent vertebrae can do. For a successful transplant, the transplant is temporarily supported and bone Must be able to grow internally. Successful dissectmy and fusion procedures Requires the development of continuous growth of bone in order to produce an individual. Because For example, the implant member cannot withstand the load of the spinal column, which is periodically compressed for the patient's lifespan. Because it is. After removing the disc, numerous attempts to restore the disc rely on metal devices. US Pat. No. 5,044,104, US Pat. No. 5,026,373, US Pat. No. 5,026,373 granted to Ray issue US Pat. No. 5,015,247 granted to Michelson; US special granted to Harm et al. Xu 4,820,305; U.S. Pat. No. 5,147,402 granted to Bohler et al.; To Brantigan Granted US Pat. No. 5,192,327 describes a hollow metal cage structure. Capital Unfortunately, the hardness of the metal causes a metal implant to push the bone graft. Shields, increases the time required for fusion, and reabsorbs bone grafts inside the cage To. If fusion is delayed and a metal implant is implanted between the discs, the device sinks Or sedimentation occurs. Also, the metal device can be fully incorporated into the fusion. There is no foreign matter. Various bone implants and bone implants to facilitate arthrodesis and gold Used to avoid the shortcomings of genus transplants. When it comes to transplantation, autologous transplantation is preferred I'm sorry. Because it promotes transplantation. Allogeneic and autologous transplants The piece is a biological material. This is over time through the transformation process of the alternative Therefore, it is replaced with the patient's own bone. Unlike metal grafts that survive after their lifetime Over time, the bone graft becomes virtually invisible. Stress shield can avoid. Because the bone graft has the same modulus of elasticity as the surrounding bone. is there. Commonly used transplant materials have a hardness that far exceeds the skin layer and spongy bone quality. Have. Titanium alloy has a hardness value of 114Gpa and is 316L stainless steel. Steel has a hardness of 193 Gpa. On the other hand, the cortical bone is about 17 Gpa. Has a hardness value. In addition, bone as a graft enables excellent postoperative image formation. To do. Because it is similar to a metal implant during CT or MRT imaging This is because it does not cause a large amount of scattering. Various implants are bone to fill the voids in the disc after removing the disc. Alternatively, it is manufactured from a graft substitute material. For example, Cloward do wel) is a circular shape created by excavating a similar or native plug. It is a graft. Cloward dowel is often between two skin layers It has perforated spongy bone. Such dwells have biomechanical properties, especially low Has a high compressive strength. Therefore, the crossword dwell is a strong periodic load of the spine. Disc without medial fixation due to risk of collapse before heavy fusion Not suitable as a spacer for. Bone dwell with great biomechanical properties, Florida 32615, Arachi S. Wing. Progress Boulevard, PO Box 31, Florida Tashba Manufactured and marketed by NK. City of allogeneic thigh or cervical joint hills It can be sold. The University of Florida has a diaphyseal skin dwell with excellent mechanical properties Expanded. This dwell is self-formed by the existing bone marrow canal of the donor's long bone It provides the advantage of having a preformed cavity. Cavity is bone or living body Packed with a bone-forming material such as ceramic. Unfortunately, there are some drawbacks to using bone grafts. Self Home grafts are available only in limited quantities. Also, additional surgeons In surgery, the risk of infection and blood loss increases and the structure at the donor site Reduces integrity. In addition, some patients have graft-incorporated surgeons. Complain that the procedure causes short-term and long-term pain. Materials for allografts obtained from donors of the same species are even easier to obtain. Shi However, allogeneic bones did not have the potential to promote bone growth in Antogenas bones. Therefore, it provides only temporary support. Slow rate fusion using allogeneic graft bone Occurs that the disk voids collapse before fusion is achieved. Allogeneic and autologous grafts are even more difficult. Grafts load the spine Does not provide the stability that needs to withstand. Internal fixation solves this problem, Presents its own drawbacks such as more complex surgery and the disadvantages of metal fixation devices To do. In addition, the surgeon repeatedly shapes the graft material to obtain the correct dimensions. Fills and stabilizes the disc voids. This trial and error method is the time required for the surgeon Increase the length. In addition, the graft material provides good friction fit between adjacent vertebrae. Has a smooth surface that does not provide. Sliding grafts damage nerve blood vessels The disc gap is crushed. Graft / fusion site even if slip does not occur Boundaries disrupt the healing process required for fusion. Avoid the shortcomings of metal and bone implants while capturing the advantages of both Several attempts have been made to evolve alternatives to bone grafts. For example, one Without the drawbacks of Unilab, Hydroxyapatite properties and bovine coller Selling spinal grafts made of gen. In each case of progress, any drawback Without a graft, which has the biomechanical properties of metal and the biological properties of bone, Extremely difficult or impossible. Need to remain in the fusion spacer to stimulate internal growth of the bone and avoid the shortcomings of metal implants Sex needs to provide sufficient strength to support the spinal column until the adjacent vertebrae fuse Sex remains. Outline of the invention According to one aspect of the invention, a spinal spacer structure for fusion of working segments. The result is provided. Spacers maintain bone formation voids and effective amounts and stimulate bone growth Includes load bearing members sized to engage the voids between adjacent vertebrae. Bone The product component comprises pure bone growth factor in a pharmaceutically acceptable carrier. In one example The load-bearing member has a bone implant impregnated with a bone-forming component. Other examples In, the bone-forming component is packed into a chamber formed in the implant. The graft is bone Includes dwell, D-shaped spacer and skin layer ring. An object of the present invention is a spine that promotes internal growth of bone and avoids stress shielding. It is to provide a spacer for engagement between bones. Another object of the present invention is in the bone. Restores disc voids and provides spacers to support the spinal column while promoting growth Is Rukoto. One advantage of the present invention is the advantages of bone implants and the advantages of metals without the corresponding drawbacks. It is to combine. Yet another advantage is the internal growth of the bone before fusion occurs. To provide a stable skeleton for the purpose. Yet another advantage is increased fusion speed By using bone grafts without the need for metal cages or internal fixation Is to be possible. Other objectives and other advantages of the present invention are described below. It will be clarified from the detailed explanation and attached drawings. A brief description of the drawing FIG. 1 is a perspective view of a bone dwell according to the present invention. FIG. 2 is a diagram showing the placement of bidirectional dwells between L5 and the sacrum. FIG. 3 is a perspective view of a cortical dwell having a chamber. FIG. 4 is a perspective view from the side of the dwell according to the present invention. FIG. 5 is a cross-sectional view of another dwell of the present invention. FIG. 6 is a side view of the dwell shown in FIG. FIG. 7 is a side view of another dwell provided by the present invention. FIG. 8 is a drawing showing details of the thread groove of the dwell shown in FIG. 7. FIG. 9 is an insertion device for inserting the spacer of the present invention. FIG. 10A is a side view of the disk space expansion. FIG. 10B is a side view of the disk space expansion. FIG. 11A is a diagram showing the seating of the outer sleeve of one fuselage. FIG. 11B is a side view showing the outer sleeve in place. FIG. 12 is a diagram showing the seating of the double barrel outer sleeve. FIG. 13 is a diagram showing the seating of the outer sleeve. FIG. 14 is a diagram showing the expansion of holes in the disk space. FIG. 15 is a drawing of the reamer used in FIG. FIG. 16 is a diagram showing tapping of disk space. FIG. 17 is a diagram showing taps used in FIG. FIG. 18 is a diagram showing an inserter engaged with a dwell. FIG. 19 is a diagram showing an inserter in the sleeve. FIG. 20 is a diagram showing the insertion of a dwell. FIG. 21 is a side perspective view of the dural retractor. FIG. 22 is a side view of the guide protector. FIG. 23 is a diagram showing the insertion of the guide protector shown in FIG. FIG. 24 is a partial cross-sectional view showing the positions on both sides of the two dwells. FIG. 25 is a partial cross-sectional view of the spine into which the skin layer ring has been transplanted. FIG. 26 is a partial cross-sectional view filled with bone-forming material. FIG. 27 is an example of another bone-generating ring provided by the present invention. FIG. 28 is another embodiment of the bone formation ring provided by the present invention. FIG. 29 is a D-shaped spacer of the present invention. FIG. 30 is a front view of the spacer shown in FIG. 29. FIG. 31 is a front view of the spacer shown in FIG. 29. FIG. 32 shows the front of the spacer of FIG. 29 showing a chamber filled with collagen sponge. It is a figure. FIG. 33 is a plan view of the collagen sponge. FIG. 34 is a graft insertion device. FIG. 35 is a D-shaped spacer of the present invention provided with a tool engaging hole. FIG. 36 is a front view of the spacer of FIG. 35. FIG. 37 is a view showing a side view of the transplant tool. FIG. 38 is a plan view of another embodiment of the spacer. FIG. 39 is a plan view of another embodiment of the spacer. FIG. 40 is a perspective view of another embodiment of the spacer of the present invention with teeth. FIG. 41 is a perspective view of another embodiment of the spacer provided with a blade. FIG. 42 is a plan view of the spacer of FIG. 41. FIG. 43 is a perspective view of a clock dwell of an autologous graft. FIG. 44 is a side view of a tritical dwell of an autologous graft. To. FIG. 45 is a side view of the button dwell of the autologous graft. Figure 46 shows the diagonal of the hybrid autologous button / autograft clock dwell. It is a visual view. Figure 47 shows a threaded tricortical (tr) with a clogged bone-forming component in the room. icortical) It is a perspective view of the diaphysical dwell of the dwell. FIG. 48 is a perspective view of a dwell with bone-forming components packed in the room. FIG. 49 is a perspective view of a dwell with a ceramic carrier packed in the room. FIG. 50 is a perspective view of an axial test fixture for testing the dwell of the present invention. FIG. 51 is a front sectional view of the fixture of FIG. 50. FIG. 52 is a fixed side sectional view of FIGS. 50 and 51. Figure 53 compares the compressive strength of a threaded cortical dwell to the spinal load in vivo. To. FIG. 54 compares the compressive strength of the load bearing member of the present invention with other known implantable materials. It is a graph. FIG. 55 is a comparison of the compressive strength of the load bearing member of the present invention with respect to the fusion cage. .. Figure 56 shows fatigue load values in various spinal implants in axial compression. It is a comparison drawing. FIG. 57 is a fixed side view for a plurality of axial load tests. FIG. 58 is a front view of the fixed object shown in FIG. 57. Figure 59 shows a skin layer dwell with threaded grooves or a fusion spacer with other threaded grooves. The insertion torque values are compared in. Description of preferred examples In drawings and certain terminology to facilitate understanding of the principles of the invention. References are made to the examples shown. Nevertheless, limiting the scope of the invention It is not intended that the present invention applies the principles of the present invention as illustrated to others. It will be understood by those skilled in the art. The present invention combines communalities with bone-forming materials such as bone morphogenetic proteins. Bone grafts are provided in the sewage. BMP combinations with bone transplants are bone Provides the benefits of grafts and is suitable for bone growth and incorporation into grafts Raise and allow the graft to fuse more quickly than the graft alone. By the present invention The rapid fusion rate provided utilizes the biomechanical properties of the implant to allow the metal interbody body. Eliminates the need for a fusion device. The spacers of the present invention provide a rapid fusion rate. No need to support the periodic load of the spine for a very long time, meeting biomechanical demands Reduce. Therefore, the present invention takes advantage of the implant while avoiding these drawbacks. To use. The spinal spacers of the present invention are located between adjacent vertebrae to maintain space. It has a load bearing member sized to engage the pace. The load-bearing member is a bone-generating material A bone graft in a communal combination. Bone graft is a suitable bone material, good Furthermore, the aggregate of human tissues including the cervical bone, fibial humerus, ilium, etc. The fee is preferable. The load-bearing member of the present invention includes a D-shaped spacer, a bone dwell, and a skin layer. Includes a ring and a properly shaped load bearing member formed from bone. Preferred load The heavy support member is obtained from a long bone diaphysis with a medullary canal that forms a natural chamber in the graft. Is done. Bone is an excellent carrier for bone-forming elements such as morphogenetic proteins It offers yet another advantage to pioneer the discovery. Skin material and chemical composition of cortical bone Hydroxyapatite, which is very similar to, has a protein distribution at the fusion site. It is a bone-forming factor binder that controls the minute rate. Binds bone morphogenetic proteins and Hydro to prevent premature disappearance from spacers before BMP emerges from fusion Calcium phosphate components such as xiapatite are considered. BMP by chemicals Retaining the protein ultimately at the rate of rapid bone completion and bone formation The quality grows cells (osteoblasts) in the device at a rate of fusion over the disk space. It is considered that it is possible to initiate the alteration of stem cells in the meantime. Of the present invention Spacers control the distribution of bone-forming factors such as bone morphogenetic proteins. Also, in the present invention, metal-like cortical bones are conventionally shaped into the various shapes shown therein. It is used when it is machined. In one embodiment, the load bearing member is Form a screw on the outer surface. Machined surfaces such as threads are metallic implants There are some advantages that it is only available with. Threaded grooves have a smooth surface Better control of spacer insertion than what can be obtained by. This is very important for surgeons regarding the neurologically and vascularly important structures of the spinal column. The spacer can be positioned more accurately. See Figure 4 -Sa 21 contains a solid protective wall 26, which is the bone-forming component in the chamber 25. Protect the spinal cord from leaking so that 30 does not escape. Smell the old way The protective wall 26 is behind. Preferably, the bone-forming component 30 is a chamber (FIG. 5 and And Figure 6) has a longer length, component 30 is a spacer 20'implanted between the vertebrae. Placed in the chamber 25 to contact the end plate of the adjacent vertebral bone when .. This provides better contact between the component and the end plate to stimulate bone formation To serve. Various features are formed on the outer surface of the dwell of the present invention. One implementation shown in Figure 7 In an example, the dwell 40 includes an outer engaging surface 41 that forms a threaded groove 42. Most The first and first thread groove 47 is adjacent to the protective wall 26'. Further to Figure 8 As clearly shown, the threads are preferably uniformly machined threads. This thread groove has a uniform machined thread groove, and this thread groove is on the front side. It has teeth 43 with a head 44 between the surface 45 and the contralateral posterior side surface 46. Preferably, the head 44 of each tooth 43 is flat. Smell in one particular embodiment The head 43 of each tooth 43 is about 0.5 mm and about 0.8 mm (about 0.020 inch and about). Has a width w between 0.030 inch). The thread groove 42 is adjacent to the tooth 43. An angle α is formed between one anterior side surface 45 and a rear side surface 46. The angle α is It is preferably between about 50 degrees and about 70 degrees. Each tooth 43 is about 0.8mm (0.030) It has a height h'of inches) and 0.11 mm (0.045 inches). Referring to FIG. 7, in some embodiments, the dwell 40 is a solid protective wall. The wall 48 opposite the 26'has a tool engagement hole 49. Tool engagement hole 49 is outside Adjacent to the psychiatrist's side, located on the surface of the dwell opposite the first screw 47. previous In the procedure, the tool engagement hole 49 is provided on the front surface 48 of the dwell 40. Other machined features are considered on the outside or on the engaging surface of the bone. This Machine features such as knurling patterns and knurling Includes rough surface finishes such as ratcheting. In the most preferred embodiment, the tool engagement hole 49 receives the threaded groove of the transplant tool. A screw groove is formed as described above. The inserter 60 shown in FIG. 9 has a handle portion 6 Including 1, the shaft 62 extends from the handle 61. The distal end 63 of the shaft 62 is Includes a tip 65 that meshes with the tool engagement hole 49. Preferably, the tip 65 and the tool The engaging hole 49 has a corresponding meshing screw 66,49A. Inserter 60 , Preferably including a T-handle for spacer control and positioning .. The shaft 62 of the inserter 60 includes a depth stop 64. Preferably, the inserter The 60 comprises means for rotating a tip portion 65 with a threaded groove. Knob 68 Through the inner shaft, which penetrates the inner hole (not shown) of the handle 61 and shaft 62 Engage with tip 65. The tip 65 is at the end of the inner shaft, the inner shaft is the handle It is rotatably mounted within 61 and shaft 62. The spacers of the present invention can be inserted using prior art. Other than the present invention According to the side of, implant an interbody fusion spacer such as spacer 40 The method is considered. These methods are interstitial for US Patent Application No. 08 / 604,874. Described in De-Fusion Methods and Devices. In the preliminary stage, fusion spacer It is necessary to place a suitable starting point for transplantation, preferably on both sides. previous In the first stage of the method of the method, the disk space of L4-L5, L5-Sl was expanded. A distractor 75 is placed between the end plates of the vertebrae (Fig. 10A and And see Figure 10B). (Of course, this procedure is added at other vertebral levels.) Figure In the second step shown in 11A, the outer sleeve 76 is the disk space IV. Placed around S. The outer sleeve 76 is clearly stiff on the anterior side of the vertebral body Engage, but temporarily secure the outer sleeve 76 in place. In essence, The outer sleeve 76 acts as a working groove in this method. preferable In an embodiment, the outer sleeve 76a of one barrel is attached to the outer sleeve 76. So finally, following the double barrel outer sleeve 76b (see Figure 12) It is inserted first. One purpose of this three-piece sleeve device is to quasi-vertebral bone It is to provide an expansion work groove for implanting fusion spacers. Figure 14 In the steps shown in, the drill or reamer (see Figure 15) is the outer sleeve. It extends through 76 and excavates a circular opening in the adjacent vertebral body. The opening is tattoo A tap is formed on the cap 78 (Fig. 17) to facilitate the insertion of the fusion spacer screw. However, this step is not always necessary. The fusion spacer 40 engages the transplant driver 60,60', as shown in FIG. As it extends through the outer sleeve 76. Then the spacer is the first screw 47 Inserted into the disc spacer IVS until is in contact with the bone opening as shown in Figure 20 Is done. The implant driver 60 has a tap formed on the vertebrae and end plate E. Screwed fusion spacers with threaded grooves into openings made or not formed Can be used for When the dwell 40 is properly placed, the knob on the tool 60 68 rotates the tip 65 with the threaded groove 65, and the tip from the hole 49 of the dwell 40. Part 65 can be removed. Inserter 60 and sleeve 76, dwell 40 Pull from the surgical site and leave the Dwell 40 in place. At this stage, other It is understandable that a suitable drive tool can be used. Closed when transplanted The trailing end 26 of the chain goes to the trailing end of the vertebra. Room 25 filled with bone-forming material is bone raw The material is placed in contact with the end plate. Aspects of the present invention will be used in conjunction with later methods. The steps of the later method are tools Conventional methods except that the device is introduced posteriorly in the motion segment of the device. Is almost the same as. This method removes the vertebral skin layer to receive the outer sleeve 76 And requires removal of the vertebrae. The dural retractor 80, as shown in FIG. 21, has a spine. Used to pull and protect the marrow and appendages. Retractor 80 is a tool Includes a handle 81 that preferably has a bend 82 that facilitates the operation of. Hard The membrane retractor 80 has an end 83 attached to a handle portion 81. end Part 83 preferably includes a curved surface 84 shaped to safely support the spinal cord. By safely pulling the spinal cord, the seat guide protector 85 (Fig. 22) It can be tapped into the position shown in FIG. Seat guide protection The ta 85 can be similar to the sleeve 76 described above. Extractor, Various tools such as reamers and taps are similar to the seat guide pros mentioned above. It can be inserted through the tecta. Fusion spacer 40 uses protector 85 It can be inserted into the expanded disk space. Fusion space for adjacent vertebrae, either anterior or posterior The position of the sa 40 is an X-ray or other suitable technique to establish an angular relationship between the vertebrae. Established by art. In another example, the preferred depth of spacer insertion is When the pacer is placed between the vertebrae, it can be measured from the outside of the patient in advance. Wear. The insertion depth of the fusion spacer is the depth mark of the transplant driver 60 (not shown). Can be confirmed by using. The spacers of the present invention are 1995, 1800, Pyramid Place, Menfi. Sofamor Danek, 1-800-933-2635, 38132, Tennessee, Su LaproscopicBonc Dowel Surgical Techniquc, 1995,1800 It can be inserted using loscope technology. The device of the present invention is a standard open The pre-peritoneal method is more surgical than the pre-peritoneal method. Incorporated into Sofamor Danek's Laproscopic Bone Dowel device to facilitate fusion be able to. This device is a type required for Laproscopic Dowel insertion, Trefin ( Includes coronary saws), dilators, reamers, ports and other equipment. It is preferable to place the dwells 40 on both sides as shown in FIGS. 2 and 24. .. This configuration provides a significant amount of bone grafts available for fusion. 2 on both sides Placing one skin layer dwell 40 is a native of bone formation across the disc voids Creeping substation while giving a large area for the placement of the bone bridge Wide range of load bearings and creeping substitution Invites long-term incorporation of cortical bone. Compared with Figures 24 to 25, 1 Provides a larger area of bone material than one ring graft 50, which is a bone-forming material Offers only one room 55, packed with 30. Two dwell arrangements produce bone-forming components Return to two rooms 25 that can be packed. In addition, the spongy bone quality of the biodegradable carrier Alternatively, a bone-forming material 30 such as BMP may be packed around the dwell. this is, Large amounts of bone-forming material and four pillars of cortical bone of the load-bearing support 35,36,37,38 To arrange. The load bearing member includes other implants such as a skin layer ring as shown in FIG. Such a cortical ring 50 is by slicing the cross section of the diaphysis of a long bone. Can be obtained and includes a top surface 51 and a bottom surface 52. The graft shown in FIG. 26 is above. It has an outer surface 53 arranged adjacent to the surface 51 and the lower surface 52. One fruit In the example, the through hole 53a through which the bone grows passes through the outer surface to facilitate fusion. Is formed. In hole 53a, the stem cells of the consciousness enter the BMP protein. Only allows it to spread outside the graft. This is the incorporation of bone grafts Allows and, if possible, forms bone on the outside of the device and before and after it hangs through it Accelerate fusion by doing so. In another embodiment, the outer surface 53 receives a transplant jig. A jig receiving hole 54 is formed. At least one neighbor in a preferred embodiment At least one top and bottom surface to grip the end plate of the tangent vertebral bone Roughly finished. The rough finish of the surface is of ring 50'as shown in Figure 27. Includes tooth 56, waffle pattern as shown in ring 50 as shown in FIG. 28. When a skin layer ring is used as the plant material, the ring 50 is as shown in Figure 26. It is further arranged into a uniform shape and left in place as shown in FIG. 28. In other particular embodiments, the spacers are inferred as shown in FIGS. 29-31. It is designed to engage between the bones. The spacers of the present invention are cervical fusion Smith Convenient to incorporate into current surgical procedures such as Robinson's technique (Smith, M) .D., GW and RA Robinson, MD, RB, Bone Surgery 40-A: 607-624 "Disc And injuries to the cervical spinal column due to posterior removal of interbody fusion "and 1958, April 22nd at the Harvey Cushion Society meeting in Washington, DC "Anteria approach to the removal of a ruptured disc"). In such a procedure, the doctor receives the graft after the disc has been removed. Prepare the end plate of the adjacent vertebral body for use. This end plate is high Prepared for parallel surfaces by a fast drill. Doctors say that the graft is an intervertebral disc Fit tightly between the surfaces of the bones so that they are held by compressing between the bodies of Shave the graft as you do. Bone grafts provide structural support and injured knots It is designed to provide a solid support. The spacer of the present invention has known dimensions. Eliminates the need to scrape this implant when legal and shaped spacers are provided. The invention also eliminates the need for donor surgery. Because the growth of the graft Because no property is needed. Spacers have bone growth potential for allografts Can be combined with bone growth material. Therefore, the space of the present invention -Sa shortens surgery time, avoids painful donor surgery, and causes rapid fusion Rub. The spacer 110 has a front wall with opposite ends 112,113 and opposite ends. It has a rear wall 115 with parts 116,117 and two side walls 120,120. .. Each of the side walls 120, 121 is between the opposing ends of the front wall 111 and the rear wall 115. Connect to form chamber 130. Each wall is made of bone and communicates with chamber 30. Includes the top surface 135 forming the opening 136 of 1. The top surface 135 is the first friction or It has a vertebral engaging surface 137. As shown in FIG. 31, the wall communicates with the chamber 130. It has two opposing lower surfaces 138 forming an opening 139. Room 130 is bone growth Dimension that receives the bone growth component is preferred. The lower surface 138 is the first friction A second friction or second vertebral clerk that is similar to or identical to the vertebral engaging surface 137 Includes mating surfaces (not shown). In one particular embodiment of a spacer that replaces the intervertebral disc, a hollow D-shaped spine Pillar spacers are provided. The front wall 111 shown in FIGS. 29 to 31 is curved in a convex shape. I'm afraid. The curvature of this anterior wall, in particular, the adjacent vertebrae and the bones of the rigid cortex of the vertebrae It is preferable to fit the shape of. The D-shaped spacer 111 is anterior to the intervertebral disc. Prevents protrusion of the lateral anterior wall 111 and is used as a spacer to be implanted in the cervical spinal column. Is especially important. In one embodiment shown in FIGS. 32 and 33, the D-shaped spacer 110 , Protein sponges, each slightly larger than chamber width W and length L 1 Including 48. In a preferred embodiment, the sponge 148 is a buffered physiology. Reconstituted with saline solution, impregnated with lyophilized rhBMP-2 and compressed into chamber 130 Is done. Sponge 148 is the wall of spacer 110 111,115,120,121 Retained in room 130 by the compressive force provided by sponge 148 against Is done. The spacer has a shape that is advantageous for cervical joint fixation. Planar shape as shown in Fig. 29 Al-A'raf 115, 120 and 121 easily integrates with Smith Robinson's surgical fusion technology Can be incorporated. Discec of part or all of the space of the vertebral bone After tomy and distraction, the surgeon, after the plane Prepare end plates for spacers to create walls and side edges. Spacer 1 10 kanhe with a flat surface relative to the posterior and lateral edges, which is the arteries of the vertebral bone and And prevent intermediate and lateral movement of the spacer 110 to the nerve. Also, bone transfer Reduces the time required for doctors by eliminating trial and error that fits well with the plant To. This is because the spacers are provided in a predetermined size. Devices such as Spacer 110 or Dwell 40 that do not have insertion jig holes , Fusion during open or percutaneous surgery using an insertion device as shown in Figure 34 Can be inserted in place. The inserter 150 has a handle that can be gripped by hand. Handle 151 with knurling pattern or other suitable pattern to improve including. The shaft 152 extends from the handle 151 and has two parts, namely the solid It is divided into a part 153 and a split jaw part 154. Split jo -Part 154 is at the distal end of shaft 152 opposite the handle 151. preferable In an embodiment, the split jaw portion 154 has a gripping surface that is offset to its free end. Includes two jaws 156 with. As shown in Fig. 34, the split jaw section Minute 154 is completely as represented by the completely separated portion of the gripping surface 158 It is movable from the released position. Split jaw part 154 has two jaws It can be closed in a completely closed position where it contacts each other. Place in a completely closed position The gripping surface shown by 158'in FIG. 34 holds the hollow spacer 110 in between. Divided at a distance close enough to hold. In particular, the closed grip surface 158 'Contact the sides of the two side walls 120, 121 of the spacer 110. One good In a further embodiment, the gripping surface 158 improves the gripping property of the spacer 110. Rough finish or a knurled pattern is formed. In addition, the inserter 150 is a three concentrically arranged around the axis 152. Including 160. Preferably, the sleeve 160 is slightly smaller than the diameter of the shaft 152. Form an inner hole 161 with a first portion of large diameter. Inner hole 161 Includes a portion 163 that extends to its distal end 164. In a preferred embodiment, When Joe 156 of Plit Joe Part 154 is in their fully open position Then Joe touches the widened portion 63 of the hole 161. When using the inserter 150, the sleeve 160 pushes the jaws together Sliding along the shaft 152 and more specifically along the open jaw 156 .. When the jaws push together, the gripping surface 158 becomes a spacer 110 as described above. Engage and grip firmly. This inserter intra-spacer 110 Can be percutaneously extended to a surgical site for transplantation into a skull space .. When the spacers are properly placed, the sleeve 160 points towards the handle 151. And receding, the natural elasticity of the two jaws 156 opens them apart and spacers Release 110. Inserter 150 injured when Joe opens completely Pulled from the point where the sleeve has, the sleeve advances along the axis, and the gripping surface 158 is spaced. Release the 110. Other details of similar devices can be found in US Pat. No. 08 / 697,784 IMPLAN. Shown in T INSERTION DEVICE. Metal spacers, insertion devices and related Methods include vertebral spacers in U.S. Pat. No. 08 / 603,675 and U.S. Pat. No. 08 / 603,6. It is shown in No. 76 INTERVERTEBAL SPACER. As another example, the spacer of the present invention has a jig for insertion, such as the jig shown in FIG. It has a joint hole. According to other specific embodiments shown in FIGS. 35 and 36, the space The riser 170 includes a front wall 171 with a jig engagement hole 174. Most preferred implementation For example, the jig engagement hole 174 is a transplant cure with a threaded groove, as shown in FIG. A thread groove is formed so as to receive the tool. Inserter 220 is the hand of the handle Knurled pattern or other suitable pattern to improve grip by To. The shaft 222 extends from the handle 221. The distal end 223 of the shaft 222 It has a tip 225 that engages with the jig engagement hole 174. Preferably, the tip 225 And the jig engagement hole 174 has corresponding meshing thread grooves 226,178. As shown in FIG. 35, if the jig engagement hole 174 is formed in a curved wall, the shaft The distal end 223 of 222 is a bent portion 22 that fits the front of the bent spacer. It is preferable to include 4. Inserter 220 has spacer control and position Includes T-shaped handle 228 for placement. Preferably, the inserter 120 Has a means of rotating the tip 225 of the thread groove. In FIG. 37, the knob 230 Engages the tip 225 via the inner shaft, the inner shaft is the handle 221 and the shaft It penetrates the inner hole (not shown) of 222. The tip 225 is at the end of the inner shaft It is preferable that the inner shaft is rotatable within the handle 221 and shaft 222. It is attached. When using the inserter 220, the spacer 170 has a threaded tip. The bent portion 224, engaged with the portion 225, is coplanar with the front wall 171. I The sensor and spacer are transdermal to implant the spacer into a disc-shaped space. It can be extended percutaneously to the surgical site. Spacer 170 is properly placed Then, the knob 230 rotates so as to rotate the threaded tip 225, and the knob 230 is rotated. The tip can be removed from the hole 174 of the pacer 110. Inserter 220 It can be pulled from the surgical site and leave the spacer in place. In a preferred embodiment, the engagement surface of the spacer engages with the end plate of the vertebra. Seen by smooth grafts processed to facilitate surgery and prepared during surgery time Prevents the spacer from slipping. Spacer 180 is as shown in FIG. On one of the upper surface 185 and one or both engaging surfaces 187 (not shown) It has a rough-finished surface 181. Roughened surface of spacer 190 191 is formed with a waffle or other suitable pattern as shown in FIG. There is. With one preferred embodiment as shown in FIG. 40, the engaging surface 201 Includes teeth 205 that provide meshing engagement with the end plate of the vertebra. In other examples Aside (see Figures 41 and 42), the spacer 210 has one or more blades 2 Includes engaging surfaces 211 machined to form 12. Each blade is at the end of the vertebra Includes a blade edge 213 shaped to penetrate the plate. Blade 212 is the first spacer Driven to the surface of the bone to increase the stability of the phase. Suitable load bearing members combined to cooperate with the bone growth component are considered .. Other possible load bearing members are allograft crok dwell (Fig. 43), 3-layer dwell. (Figure 44), Button Dwell (Figure 45), and Hybrid Allogeneic Graft Clock Includes dwell (Fig. 46). The bone growth material is impregnated with a solution containing bone components and the implant and is shown in Figures 32 and 47. By packing 30,148 such bone growth materials in chambers 25,130, Applies to the spacers of the present invention by combining the methods. Ingredients Applied by the surgeon during surgery, spacers are pre-applied Supplied with ingredients. In such cases, the bone growth component is carried, such as by lyophilization. Stable in shipping and storage. Stable ingredients such as saline or water Rehydrated or rehydrated with sterile fluid or body fluids added before and after transplantation .. Suitable bone-forming materials or ingredients are autologous grafts, allografts, xenografts, desalting Synthetic and natural bone graft alternatives such as bone, bioceramics and polymers And those containing bone growth factors are considered. Bone growth components used herein The term bone containing natural, synthetic and recombinant proteins, hormones, etc. Means the de facto material that promotes the growth or treatment of. Autologous grafts can be drilled, gauged, or curetted from a location such as the apex of the ilium. Public to doctors in this area using (spoon-shaped instruments), trephins, and other jigs Collected by a well-known method. Autologous grafts are minimal Donner's hands It is preferably taken from the apex of the ilium by surgery. The implant is at the end of the spacer Bone cells or other bone that has been perforated by the surgeon while preparing the plate Including. Fortunately, when choosing an autologous graft as the bone growth material, room 130 Only a very small amount of bone material is needed to fill it. Autologous graft itself Provides a structural support when this is provided by the spacer 110 That is not needed. Donor surgery, such as a small amount of bone, invades healthy tissue Less tolerated and more tolerable to the patient. In obtaining such a small amount of bone There is almost no need to make an incision in the muscle. Therefore, the present invention has a large number of self. Eliminates many inconveniences of home grafts. The bone growth component used in the present invention forms morphogenesis on a pharmaceutically acceptable carrier. Contains therapeutically effective amounts of near-pure bone-inducing factors such as protein. Prefer Bone formation-inducing factors are recombinant human bone morphogenetic proteins (rhBMPs). Is. Because they have an unlimited source of infectious diseases Because it will not be carried. Most preferably, the bone morphogenetic protein is rhBMP- 2, rhBMP-4 or its heterodimer. The concentration of rhBMP-2 is about 0.4 It is between mg / ml and about 1.5 mg / ml, preferably around 1.5 mg / ml. .. However, bone morphogenetic proteins designated as BMP-1 to BMP-13 Bone morphogenetic proteins, including quality, are considered. BMP is in Massachusetts Commercially available from Genetic, Cambridge, USA, granted to Wozney et al. Patent No. 5,187,076, U.S. Pat. No. 5,366,875 granted to Wozney et al., Wang et al. U.S. Pat. No. 4,877,864 granted, U.S. Pat. No. 5,108,922 granted to Wang et al., US Pat. No. 5,013,649 granted to Wang et al., Visiting Patent No. 5 granted to Wozney et al. , 106,748, PC given to Wozney et al. TWO93 / 00432, PC given to Celeste et al. It is explained in TWO94 / 26892. All bone growth-inducing factors are as described above It is considered whether it is obtained or separated from the bone. Bone to bone morphogenesis A method for separating proteins was granted to Uristo in 1984, U.S. Pat. No. 4,294, Explained in No. 754, 81 PNAS371. The choice of carrier material for bone-forming components is biologically compatible and biodegradable. Based on the mechanical and interface characteristics and the structure of the load bearing member I am. Specific specific applications of the components of the invention are defined by appropriate formulas. Tan The powder carriers are calcium sulfate, polylactic acid, polyanhydride, Collagen, calcium phosphate, polymer acrylic ester and desalting Includes bone that has been removed. The carrier is a suitable carrier capable of distributing the protein. .. Most preferably, the carrier can be uniformly reabsorbed by the body. One A preferred carrier is the absorbable collagen Hemostatic agent, trade name Helistat. Absorbable collagen sold by Integra Life Sciences below It is a sponge. Another preferred carrier is an open-cell polylacty acid polymer. (OPLA). Another possible matrix of its constituents is biodegradable chemicals. Calcium sulfate, tricalcium phosphate (TCP) defined in ) Like calcium phosphate and hydroxyapatite (HA), infusion With possible bicalcium phosphate (BCP) and polyanhydride is there. Other possible materials are biodegradable, such as collagen in bone or skin. Can be obtained biologically at. In addition, the matrix is pure protein or It consists of extracellular matrix components. Bone morphogenetic materials are BMP and polymethyl. It is a mixture with a polymeric acrylic ester carrier such as methacrylic acid. To fill the spacer chambers of the present invention, the carrier is chamber 55 (FIG. 25) or chamber 25. Sponge 58,30 which can be compressed to (25) or as shown in FIG. A carrier such as a strip or sheet adapted to fit the room is provided. To. In the most preferred embodiment, the carrier is immersed in a solution of rhBMP-2 and pressed into the chamber. Be shrunk. As shown in FIG. 47, the sponge 30 is provided by the dwell 21. It is held in the chamber 25 by the compressive force. Highly vascularized surrounding fusion carrier The carrier extends outside the opening of the chamber to facilitate contact between the tissue and the bone-forming components. It is preferable to go. The carrier is provided on several strips to fit indoors. Can be served. The strips can be stacked to fill the interior it can. As with the folded sheet, the strips have some in the spacer Arranged to face the direction. Preferably, the bone-forming material provided in the sponge , Diffracted sheet or stacked several times corresponds to the length and width of the chamber Has a length of The most preferred carrier is a two-phase calcium phosphate ceramic. Figure 49 shows the ceramic carrier 32 packed in the dwell 40. Desire in vivo Hydroxyapatite trical due to its bioactive properties and rate of deterioration Sium phosphate is preferred. Hydroxyapatite and tricalcium The ratio to phosphate is preferably between about 0: 100 and about 65:35. load A ceramic carrier that fits into the chamber formed in the bearing member is considered. ceramic The block is Sofarmor Danek Group, BP4-62180 Rang-du-Fliers, France And Bioland, 132 Route Commercially available from d: Espagne, 31100 Toulouse, France. There is. Of course, rectangles and other suitable shapes are considered. Bone growth factor is appropriate It is introduced into the carrier by various methods. For example, the carrier is immersed in a solution containing the elements. In a preferred embodiment, the bone growth component is provided in the holes of the load bearing member. Bone The growth-inducing component is introduced into the hole in an appropriate manner. For example, the component is a hole in the graft Is injected into. In other examples, the component is dropped onto the implant or the implant is Immerse in a solution containing an effective amount of ingredients to stimulate bone growth. Smell in other cases The holes are long enough to allow the graft to be completely submerged in the liquid. Therefore, it is exposed to the ingredients. Bone-forming components, preferably BMP, were lyophilized Provided in the state, a pharmaceutically acceptable liquid or di Provided by a carrier or other suitable carrier. The carrier is a protein It is a suitable medium that can be sent to the service. Preferably, the medium is in this art. It is supplied by a well-known buffer solution. One feature of the present invention In certain examples, rhBMP-2 can be infused with water, saline, liquid collagen or B. Suspended and mixed in a carrier such as CP. Is the BMP solution dropped onto the implant? , Or the implant can be immersed in an appropriate amount of liquid. Most preferred embodiment In, the BMP solution is sent to the hole in the implant and either lipolized or frozen. It is dried. Graft BMP components can be frozen for containment or transport Wear. Advantageously, the spacers between the vertebral bones of the present invention do not require internal fixation. Spa The surrounding ligaments and muscles, the disc annulus, if not completely removed Wrapped by the compressive force of the body. Equipment along with neck collar, lumbar brace, etc. Is attached and temporary external immobilization and support of adjacent vertebral levels is appropriate Can be recommended until a good fusion is achieved. The spacer of the present invention and its configuration are Generally, it is not necessary to use a metal device, and the present invention is combined with such a device. It is advantageous to let them. The bone graft growth component of the present invention is contained in a conventional metal cage. Will be transplanted to. The following specific examples of the present invention are for purposes of explaining the present invention and limit the present invention. It is not intended to do that. Experiment 1: Equipment preparation Example 1 Diaphyseal cutaneous bone dwell Extensive immunodeficiency virus, herpes virus, hepatitis B, hepatitis C and going Donors who have agreed on a wide range of infectious diseases and pathogens, including some other pathogens (eg For example, a donor card, or other form of consent that acts as a donor) is sifted. Can be called. These tests include ELISA analytical evaluation, PCR analytical evaluation or hemagglutination. Including, but not limited to this. Such trials are: (i) Tissue Bank Ameri Association, Tissue Bank Technical Manual, Technical Manual-Musculoskeletal Tissue, Page M1 9-M20, (ii) Ministry of Food and Pharmacy, Provisional Regulations, Federal Registration No. 238, Vol. 50/19 Tuesday, December 14, 1993, / Regulations and Ordinances / 65517, D, Infectious Disease Testing and De Nursing, (iii) MMWR / Vol.43 / No.PP-8, of human tissues and organs Guidelines for preventing the transmission of the human immunodeficiency virus through transplantation, (iv) Weekli, Lorida, August 21, 1992, Volume 10, Issue 10, 59A-1.00 1-014 59A-1.005 (12) (C), FAC, (12) (a)-(h), 59A-1.005 (15), FAC, (4 ) Follow the requirements of (a)-(8). In addition to batteries with standard biochemical analysis results, Donna -Or a relative has multiple sexual companions and is infected with hemophilia or given an intravenous injection Make sure you don't have a number of major risks, such as the use of drugs by To be interviewed. Acquire a dwell after the donor receives consent Restore and clean effective bones. A diamond tip cut bit that gives a dwell, is cleaned and cooled with water Obtained as a lateral plug from the diaphysis of a long bone using a gut. The tip is the city It is sold (Starlight) and is almost circular, about 10 mm to about 20 mm. It has the diameter of the inner cavity between. The internal and skin layer dwell acquisition machine is Stenle It consists of steel and anodized air-operated small lathes. Mosquitoes It has a spring-loaded carriage that transitions parallel to the ter. Two carriages Placed on top of the runners, these runners are 1.0 inch (2.54 cm) Tenless steel rod with a distance of approximately 8.0 inches (20.32 cm) To do. One runner has a set pin hole on the running rod, and this set pin hole , Prevents the carriage from moving when the assembly pin is placed in the desired hole. The carriage can be moved from side to side by a knob, which is Tar is written in English step by step. This allows the implant to be positioned Can be done. In this carriage, when the dwell is cut, the vise is transplanted Clamp the piece and hold it in place. Vise forms a void in the cutter The jaw has a cutout area to do so. Raise can set the desired RPM It has a drive device that is an air motor with a valve controller that can be used. First, the carriage is pulled manually and secured in place with a pair of pins. No. In 2, the graft is placed in a vise and aligned with the cutter. Third, the machine is a star The RPM is set by turning on and using the valve control knob. No. On 4, load the set screw that loads the graft on the cutter to cut the dwell. The cutter cuts all passages through which the graft passes, and the carriage stops in a pin-up. Fifth, sterile water is used to release the dwell to the outside of the cutter. that is, Fully autoclaved and holds the graft to cut the dwell To have a stainless steel vise and / or fixture. Graft is 0.02 Placed within mm (0.001 inch), this provides dwell uniformity during the cutting process come. The cutters used in connection with the machines mentioned above are dwells in the range of 5 mm to 30 mm. The dimensions of the cutter are 10.6mm, 11.0mm, 12.0mm, 1 It is 3.0mm, 14.0mm, 16.0mm, 18.0mm. Cutter composition Is stainless steel and has a very smooth surface on the dwell wall. In addition, sterile water is used when the dwell is cut (hydroinfusion). Used to cool grafts and / or dwells and remove debris from them Is done. Water travels down through the center of the cutter to clean the pressurized dwell. , Wash. In addition, water assists in releasing the dwell from the cutter. Bone marrow is removed from Dwell's bone marrow canal and the cavities are cleaned to create a chamber Will be done. The last machined product is housed and frozen for later use , Freeze-dried. Example 2 Dwell with screw A diaphyseal skin layer dwell as described above is prepared. Preferably, a class 10 chestnut The plug is machined to the desired dimensions in the room. Machining is a treasure It is preferably done in a raise, such as a stone raise, especially mechanical for this purpose. A processed jig may be prepared and applied. Drill on the front wall of the dwell The hole is pierced. The hole is tapped to receive a threaded insertion jig It has been. Example 3 Bone dwell immersed in rhBMP-2 Screwed dwells are obtained through the methods of Examples 1 and 2. 4.0 mg / bottle containing 4.0 mg lyphylized rhBMP-2 Next with 1 mL of sterile water (Abbott Laboratories) to inject to obtain a mL solution It is configured as follows. Use a 1.3cc syringe and a 22G needle. Lyphylize Slowly inject 1.0 mL of sterile water into the bottle containing rhBMP-2. 2. Shake the bottle slowly until a clean solution is obtained. The following dilution method is used to obtain an appropriate concentration of rhBMP-2. this Dilution provides sufficient volume for the two glass bottles. This dilution is fruitful as follows Will be done. 4.0 mL MFR906 buffer (Genetics Institute) using a 1.5 cc syringe ) Slowly in a sterile bottle. Buffer 0.70 mL of reconstituted rhBMP-2 using a 2.1c syringe (Ge) Transfer to a sterile bottle containing netics Institute). 3. Shake slowly to mix. Dilution method First rhBMP-2 rhBMP-2 MFR-842 Last rhBMP-2 Concentration Volume Volume Volume Concentration (mg / mL) mL mL (mg / mL) 1.0 0.7 4.0 0.06 Use a 1.1.3cc syringe and a 22G needle. 2.0 mL 0.60 Gently add mg / mL rhBMP-2 solution to the bone dwell. 2. Immediately transplant. Example 4 Bone dwell packed with BMP-2 / collagen component Screwed dwells are obtained through the methods of Examples 1 and 2. 4.0 mg lyphylized rhBMP-2 (Genetics Institute) 1 mL of sterile water (Abb) so that the bottle containing) is injected to obtain a 4.0 mg / mL solution. ott Laboratorics) is configured as follows. Use a 1.3cc syringe and a 22G needle. Lyphylize ) Slowly inject 1.0 mL of sterile water into the bottle containing rhBMP-2. 2. Slowly swirl the bottle until a clean solution is obtained, but shake Try not to. The following dilution method is used to obtain an appropriate concentration of rhBMP-2. this Dilution is performed as follows. 2.5 mL MFR842 buffer (Genetics Insti) using a 1.3.0 cc syringe Tute) slowly in a sterile bottle. 0.30 mL reconstituted 4.0 mg / mL rhBMP using a 2.1 cc syringe Transfer -2 to a sterile bottle containing buffer (Genetics Institute). 3. Shake slowly to mix. Dilution method First rhBMP-2 rhBMP-2 MFR-842 Last rhBMP-2 Concentration Volume Volume Volume Concentration (mg / mL) mL mL (mg / mL) 4.0 0.3 2.5 0.43 rhBMP-2 solution to Helistat Sponge (Genetics Institute) as follows Applies. 1. Using sterile tweezers and scissors, 7.5 cm x 10 cm (3 "x 4") Cut a 7.5 cm x 2.0 cm strip of Helist from the sponge. Use a 2.1cc syringe and a 22G needle. 0.8 mL 0.43 mg / mL Gently drop the rhBMP-2 solution onto the Helistat sheet. 3. Using sterile tweezers, slowly pack the sponge into the dwell chamber. Use a 4.1cc syringe and a 22G needle. The remaining 0.8 mL 0.43 mg / mL The rhBMP-2 solution is injected into the dwell sponge through the opening of the chamber. 5. Immediately transplant. Example 5 Bone dwell packed with BMP-2 / HA / TCP components Screwed dwells are obtained through the methods of Examples 1 and 2. 4.0 mg lyphylized rhBMP-2 (Genetics Institute) 1 mL of sterile water (Abb) so that the bottle containing) is injected to obtain a 4.0 mg / mL solution. ott Laboratories) is configured as follows. Use a 1.3cc syringe and a 22G needle. Lyphylize ) Slowly inject 1.0 mL of sterile water into the bottle containing rhBMP-2. 2. Slowly swirl the bottle until a clean solution is obtained, shake Try not to. Two-layer hydroxyapatite / tricalcium phosphate (viola) Wet the cylindrical block with 4.0 mg / mL rhBMP-2 solution. BMP ceramic Blocks are packed in Dwell's room and Dwell is transplanted. Example 6 Skin layer ring The selection of agreed donors is done as described in Example 1 as follows. Human Obtained as a cross-section slice of the long bone diaphysis and prepared using the method shown in Example 1. Is done. This ring is packed with bone growth components as described in Example 4 or 5. Example 7 Spacer The selection of agreed donors is done as described in Example 1 as follows. D shape Skin layer spacers are obtained as slices of the cross section of the diaphysis of long human bones, in Example 1. Prepared using the method shown. The outer surface of the wall is a machine that slices slices into a D shape It is formed by processing. The engagement surface of the spacer depends on a standard excavator A knurling pattern is formed. A hole is drilled through the front wall of the spacer. next The holes are tapped to engage the threaded insertion jig. Spa The chamber is filled with bone-forming components as described in Example 4 or Example 5. Experiment II Biological test Example 10 Static test of skin layer dwell with threaded grooves under axial load Static tests are physio with a maximum predicted load of at least 10,000 N Must be able to withstand physioloc loads. 18mm outer diameter Frozen threaded skin layer dwell 40 obtained from the University of Florida Organization Bank And thawed for testing with the axial test fixture 300. Thread groove Four samples of skin layer dwell with a screw, as shown in Figures 50-52 Two prepared plastics with a mechanical shape with a grooved skin layer dwell 40 (Polyacetal polymer) Inserted into blocks 301,302. This plus Tick blocks 301,302 guarantee a uniform load across the dwell 40 Was attached to metal blocks 301,302. 9mm disc height H , Used for testing. Axial load P is block 3 at a speed of 25 mm / min Added to 01,302,303,304 via servo hydraulic test machine Is done. The load deviation curve was recorded. result: The threaded dwell was loaded with an average load of 24,733N. Thread groove The compressive strength of the formed skin layer dwell is generally the maximum raw, as shown in Figure 53. It provides a large safety factor compared to the physical spinal load. These values are heavy In the ascent, range from 1000N when withstanding up to 10,000N Is. The compressive strength of the threaded crusted dwell and crust ring is shown in Figure 54. Exceeds the strength of the most available bone material used for fusion within the body, as shown in To. Overall, the threaded dwell and skin ring is the femoral ring. Except for allografts, they showed excellent compressive strength compared to the available choices. It should be noted that the test was done with respect to the single dwell. Therefore , The average maximum compressive load predicted for the two dwells is 49,466N. .. Threaded cutaneous dwells are compared to artificial implants in the body as shown in Figure 55. .. Example 11 Dynamic test of cortical dwell with threaded grooves under axial load Dynamic testing determines dwell fatigue performance under periodic loads. Against fatigue The cycle is determined at various load levels. Resistance to fatigue affects spinal transplantability It's very important. Transplantation must withstand periodic internal loads until fusion occurs Must be able to. The average person walks 2 million times (1 million walk cycles), 1 It bends 125,000 times a year. Therefore, a normal dynamic test run of 5 million cycles Before the runout values merge and stabilize the complete spinal movement segment , Perform a simulated experiment with a periodic load for almost 2 years. Fixture 300 (FIGS. 50-52) shown in Example 11 is a variety of implants and Used to alternately load the dwell. Initial fatigue load is maximum static It is determined based on the stop load value. The initial fatigue load is 75, the ultimate value of 24,733N. They were%, 50% and 25%. Determine the runout value for 5 million cycles Additional data points have been generated for this. result: Based on the psychological load values mentioned above, the daily load value is a fraction of the maximum value. Predicted to be, evaluated at almost 3200N. This normal load value is for various bodies Used to evaluate the performance of internal fusion alternatives. Skin layer dwell with thread groove In, runout is achieved at a level of 30% of maximum static load. sand That is, the minimum two samples have a load of 7,420 N of 5 million, as shown in Figure 56. Added times. This value is greater than or equal to the average load value of 3200N. Example 12 Static / dynamic test of skin layer dwell with threaded groove under bending load Compression tests provide a comparable upper value for dwell dynamic and quiescent performance However, it is a simplification of the load by the dwell in the setting of treatment. Therapeutically Further simulation of the load shows fixed extension or periodic test fixing in multiple axes 31 0 was developed (see Figures 57 and 58). Dwell is a stationary / dynamic load situation So it was tested. A specially designed fixture is a combination of multiple axes that are guided by a dwell. A load was applied. Dwell is a pre-tapped plastic (polyacetal po) It is placed in blocks 311,312 of Rimmer). Plastic block 31 1,312 has recesses on the upper 315 and lower 316 of the metal test fixture 318. It is fixed in the pockets 313,314 made. Vertical load L is fixed extension Added to generate a bending moment. A periodic compressive load is applied, and the song The momentum is generated by a 7.6 cm load arm. The two dwells are subject to a static load with respect to test fixture fatigue. Dynamic load value Maximum load was used to determine. Completely reversed in fatigue test A load is applied and a simulated experiment of the deflection extension cycle is performed. Periodic test is maximum load Runs at 40%, 30%, and 20% of the values and runs 5 million cycles The value has been determined. result: The average static load for the fatigue value of the skin layer dwell of the thread groove is 1,545N. I found out. For a 7.6 cm moment arm, this is a maximum of 138 N-m It is converted to the limit bending load. The runout value for 5 million cycles is almost 450N is there. Again, for a 7.6 cm moment arm, this is 40.5 Converted to a bending load value of Nm. Fatigue load of bending lumbar movement segment Is on average 33_NmIs reported to be. Maximum static load value is from this value More than four times larger, dynamic, multiple axial runout values make this maximum bend It is more than the load value. Example 13 Insertion torque test of skin layer dwell with threaded grooves Benchtop tests insert dwells and set these values in the threaded body Performed to study the insertion torque required to compare with the insertion torque of the fusion device Will be done. Two lumbar calf spines were used for the insertion torque test. Size Due to the above constraints, the 18mm threaded cortical dwell is the bottom two spinal columns. Inserted into the lumbar level of. The disc spacer is diluted and the space is Lee A hole is made with a ma and a tap is formed. Especially for deformed drivers, dwell Used to place and place to measure insertion torque. result: It should be noted that there was no damage to the dwell in the post-insertion test. is there. These insertion torque values are 0.78 Nn. Skin layer dwell with threaded groove Is compared to known values for metal thread fusion shown in FIG. 59. Outline of dwell test with threaded groove Biochemical tests show that threaded cortical dwells apply to fusion within the body Shown to be appropriate. This test information is summarized as follows: 1. The resting strength of the skin layer dwell with threaded grooves is at the maximum psychological load level. Throughout, it is provided with almost safe factors. Dwell is stronger than other bone dwell structures I. These strengths exceed the strength of Brantigan's composite PLIF cage and Ray TFC equipment. Eh, it is comparable in strength to SpineTech BAK. 2. Fatigue strength of threaded cortical dwell is conventional clock type bone Beyond the strength fatigue of the dwell, it is almost safe over normal daily living load levels Provide the element. Dwell fatigue strength is comparable to the SpineTech BAK device . 3. Dwell resists maximum bending load and provides near safety element at static load Shows a runout of 5 million cycles at a value above the maximum expected bending load. 4. The torque required to insert this device is visible in the threaded fusion cage It is comparable to something like that. When inserting a dwell, and fixing the dwell Do not damage the threaded groove or dwell drive mounting device. Overall, the threaded cortical dwell contains the fusion of the lumbar spine into the body. Retains the biochemical properties needed to facilitate. Those physical Strength exceeds expected physiological loads and is superior to alternatives to other bone grafts There is. Dwell is superior to all currently available fusion cage alternatives to it It is comparable. Example 14 Evaluation of rhBMP-2 as a bone graft improving agent An object of the present invention is to fill the voids surrounding a porous coated implant. To determine the effect of using BMP to increase allogeneic grafts. Non-heavy A volume-supported Kanin-type model is used. raw materials Material Source / Lot #Comment Supply rhBMP-2 Genetic Society Lot # 5 mM Glutamic Acid 0214COTQFill Sodium From 4 mg / mL rhBMP-2 MER842 buffer 2.5% glycine 4 mg / vial iyo. 4 bottles of 0.5% sacroze 0.01% Tween 80 PH4.5 Buffer MFR842 Genetic Society 5 mM Glutamic Acid Lot # 26256 to sodium 4mg / mL rhBMP-2 2.5% glycine 5 mL / vial 4 bottles of 0.5% sacroze 0.01% Tween 80 PH4.5 Radiant fresh Frozen canin type allograft donor canin radiation 2.5Mrads almost (24-26KG's) 10-15mLs Vitalium Porous coat Plug Hownmedica 6.4mm Diameter N / A Teflon Hownmedica ID 6.4mm OD 10.4mm N / A Native blood N / AN / AN / A Sterile water for injection Abbot Labs Lot # 90-544-DK WFI USP Grace 10mL / bottle In 4 bottles Composition and graft preparation 1. Allogeneic graft a. Draw 1 mL of dog blood. b. Add dog blood to a sterile 1.5 mL Ependorff tube. c. Mark the level on this tube. d. Mark the level on the second tube and discard the tube containing blood. e. Mark the level on three other tubes. f. Add allogeneic graft to the level marked on this tube. 2. Allogeneic graft / blood / rhBMP-2 components a. Reconstruct rhBMP-2 using sterile water for 1 mL injection (WFI) at room temperature To do. Inject WFI into the inner surface of rhBMP-2 along the inner surface of the bottle. Shake the bottle 3-4 times. The final concentration is 4 mg / mL. b. Draw 1.0 mL of dog blood and place in a sterile Ependorff tube. c. Draw 0.550 mL of blood from the tube and place it in a second Ependorff tube. d. Add the reconstituted 0.050 mL rhBMP-2 solution blood to 0.550 mL of blood. Eh, mix slowly with the tip of a siliconized pipette. e. 0.300 mL mixed solution of blood and rhBMP-2 in Ependl containing allogeneic graft Add to the tube. f. Slowly mix this ingredient with a sterile spatula until well mixed. Mix. g. Leave at room temperature for 1 hour. 3. Allogeneic graft, blood, MFR82, ingredients draw 1.0 mL of dog blood and place in a sterile Ependorff tube. b. Draw 0.550 mL of blood from the tube and place it in a second Ependorff tube. c. Add 0.050 mL of MFR842 buffer to 0.550 mL of blood and siliconize. Mix slowly with the tip of a pipette. d. 0.300 mL of mixed solution of blood and rhBMP-2 in Ependl containing allogeneic graft Add to the tube. e. Slowly mix this ingredient with a sterile spatula until well mixed. Mix. f. Leave at room temperature for 1 hour. Surgery On the thigh joint hill with a 2 mm cap maintained through the spongy bony area of the joint hill Graft components are placed across. The component on the left contains a new cryograft and is grown on the right Minutes include new cryografts plus rhBMP-2 as shown in the table below. plan Dog ID control processing time; Bone graft only Bone + rhBMP-2 94-975 Right foot Left foot 14 days 94-973 Right foot Left foot 14 days 94-913 Right foot Left foot 28 days 94-914 Right foot Left foot 28 days The transplanted components are evaluated by X-ray and the effect is biomechanical specialized test or push. Tested using Shuout. The 5 mm thick part is the side edge of the metal implant By cutting 5 mm from and forming a second 5 mm cut from this cut. Can be obtained in a pushout test. This repositions the bone block By arranging, each bone specimen except one specimen that makes four parts There are three parts in. Biochemical tests are computer-linked servos Completed using a Howdralic material tester. result: The surgery was successful. The dog was full weight bearing within 3 days (2 +/- 1.15). Preoperative x-rays of the distal thigh from all animals grow normally without x-ray pathology Represents the structure of the bone. Post-surgery terminal evaluation of the transplant site is the correctness of the transplant site Is performed to evaluate and record changes around the transplant site. In the X-ray image No fractures or other surgical complications were found. Pushout (compression) was achieved using a speed of 0.5 mm / sec. All In the specimen, a failure appeared at the graft-metal boundary. All 2 week specimens are fingers Easily pushed out (compressed) by touching with, or by gravity alone. push Out-testing is suitable for comparing treated vs. untreated groups at this time It does not appear in the parameter. Specimens from animals treated at 4 weeks are shown in the table below. Clearly superior to untreated specimens. Addition to the failure value Dog ID Time after surgery Left graft + BMP Right graft alone 94-975 2 weeks 8.71 24.43 94-973 2 weeks 17.45 12.22 94-913 4 weeks 82.88 41.88 94-914 4 weeks 76.78 13.96 The pushout intensity of BMP-treated specimens was increased to graft specimens alone after 4 weeks. On the other hand, it is excellent and shows the BMP strength of mechanical strength. Injury at the graft metal boundary Shows a weak bond between metal and bone over 4 weeks after surgery. Conclusion: The combination of BMP and bone graft shows excellent results. Faster fusion , Provides improved mechanical strength immediately. Bone controls release of BMP to fusion site It is an excellent protein carrier. Cutaneous dwell with threaded bone grafts When the load-bearing dwell is biochemically superior, the combination of BMP bones Combined with an improved fusion rate. The present invention has been described in detail with reference to the drawings and the above-mentioned contents, but these contents are examples. It is not intended to be restricted. Preferred examples are shown and described in the book. It should be understood that the transformations and modifications in the spirit of the invention should be protected. is there.