JP2005510258A - An assembled implant comprising a mixed composition segment - Google Patents

Abstract

  The present invention provides a method for manufacturing autograft, allograft and xenograft implants, which can be constructed by assembling such implants from smaller pieces of graft material. Forming a graft implant product. One segment of the assembled implant graft comprises two or more discontinuous regions, which have different characteristics and / or properties. The present invention also provides kits comprising assemblable parts of autograft, allograft and xenograft implants, which kits can be used to remove such implants from smaller pieces of graft material. Assemble to form a larger graft implant product, which can be formed over the course of a surgical procedure to accurately fit the requirements of a given patient or procedure.

Description

(Cross-reference of related applications)
This application is based on US application Ser. No. 09 / 782,594 filed Feb. 12, 2001 (pending) (this is a continuation of U.S. Ser. No. 60 / 181,622 filed Feb. 10, 2000). And US Application No. 09 / 378,527 (pending) filed Aug. 20, 1999 (this is a continuation of US Application No. 09 / 191,232 (pending) filed Nov. 13, 1998). And U.S. Application No. 09 / 370,194 filed September 7, 1999 (pending); and U.S. Application No. 29 / 123,227 filed May 12, 2000; and 2000. US Application No. 09 / 528,034 filed on March 17, which is a continuation of US Application No. 09 / 481,319 filed on January 11, 2000; and National Patent Application No. 09 / 363,909, and continuation of related PCT Application No. PCT / US00 / 20629 filed July 28, 2000 and published as WO 01 / 08715A1; US Patent Act, Section 119 And under section 120 these claims and benefits are claimed herein. All of these applications are incorporated by reference.

(Field of Invention)
The present invention relates to implants and methods for their preparation, wherein the implant parts are assembled from component pieces to produce a complete implant. The implant according to the present invention comprises two or more segments consisting of mineralized or demineralized bone segments or segments comprising both mineral removal and mineralization regions in parallel with each other.

(Background of the Invention)
There is an increasing need in the medical field to develop implant materials for the correction of biological defects. There is a need to replace or correct bone, ligament and tendon defects or injuries, particularly in the field of orthopedic medicine. As a result, a large number of synthetic implant materials (including metal implant materials and devices, devices composed in whole or in part from polymeric substances, and allografts, autografts and xenograft implants, But not limited to). It is generally recognized that for implant materials to be acceptable, they must be pathogen free and biologically acceptable. In general, if the implant material can be reconstructed over time, it is preferable that autologous bone replace the implant material as a result. This object is best achieved by utilizing autograft bone from the first transplant site for transplantation to the second site. However, the use of autograft material is significant in that the site of the second pathological condition must be made to collect autografts for transplantation to the first disease site or injury site. Attention has been paid to the shortcomings. As a result, allografts and xenografts have received increasing attention in recent years. However, the use of such materials has the disadvantage that human allograft materials are often not available and the cost of recovery, processing and preparation for transplantation is high. In contrast, xenograft materials (eg, bovine bone) can be readily available, but immunological and disease transmission considerations are a significant constraint on the easy use of such materials. Is implied.

  In view of the above considerations, there remains a long felt need for unlimited replenishment of biologically acceptable implant materials for the repair of bone and other defects or injuries. The present invention provides significant advantages in the art by providing materials and methods for generating virtually any form of implant from component parts to produce an assembled implant. Satisfy this need a lot. In particular, the present invention shows compositions, methods and kits related to implants, wherein at least one single segment is demineralized or of mineralized and demineralized areas. Includes combinations. Depending on the particular implant and its use in the patient in need thereof, advantages in strength, structural support and flexibility are among the advantages of the present invention.

  In addition, US Pat. No. 5,899,939 to Boyce, issued May 4, 1999, the disclosure of which is hereby incorporated by reference as if fully set forth herein. Are referred to herein.

  Finally, US Pat. No. 6,025,538 to Yaccino (issued February 15, 2000), the disclosure of which is incorporated herein by reference as if fully set forth herein. Are referred to herein.

  The present invention provides a combination of mineralized and demineralized regions provided in a single segment (separate pieces) (see US Pat. No. 6,200,347 (single segment). Advances the technology beyond the above cited references by disclosing and claiming implants containing) as distinguished from those disclosed in (Teach Homogeneous Mineral Removal). The importance of demineralized bone in the implant is described in U.S. Patent No. 6,090,998, and U.S. Patent Application Nos. 09 / 417,401, 09 / 518,000, 09 / 585,772, And 09 / 778,046, all of which are assigned to the designated agent of the present invention and all of which are incorporated by reference.

(Summary of the Invention)
The present invention provides a method for the manufacture of autograft, allograft and xenograft implants comprising assembling such implants from smaller pieces of graft material; Forming a larger graft product. Some pieces of such graft material for assembly are demineralized and combined with other pieces of mineralized graft material.

  Accordingly, one object of the present invention is to provide a method for assembling multiple bone graft shapes from smaller bone graft fragments.

  Another object of the present invention is to provide an assembled bone graft. Related to this purpose is assembling the components of the assembled allograft in such a way as to compensate for the unbalanced shrinkage between the components during lyophilization to still obtain an accurate interference fit. Is the purpose.

  Another object of the present invention is to provide a method in which otherwise discarded tissue can be used in the manufacture of useful orthopedic implants.

  Another object of the present invention is to provide an implant having a combination of at least one demineralized region in parallel with at least one region mineralized. Another object of the present invention is to combine segments of implants with other mineralized segments and combinations of mineralized and demineralized regions.

  Further objects and advantages of the present invention will be understood in light of the full disclosure and appended claims.

Detailed Description of Preferred Embodiments
Currently, autograft products, allograft products and xenograft products are produced as solid continuous materials. For example, bone dowels (see US Pat. No. 5,814,084 (incorporated herein by reference)), Smith-Robinson cervical spinal implants, iliac crest implants, etc. Collected from a single continuous piece and machined. The present invention provides a method for making autografts, allografts and xenografts, which assembles such implants from smaller pieces of graft material to produce larger graft implant products. By forming. As a result, increased utilization of valuable implant materials is achieved, thereby more effectively meeting the ever increasing demand for implant implant materials. Furthermore, greater conformability has been achieved in the type and shape of the implant material. Essentially any implant that may be required can be formed in accordance with the present invention, providing an orthopedic surgeon with a kit of assembleable parts that can be formed in a series of surgical procedures, for a given patient or procedure. Meet your requirements exactly. In yet another aspect of the present invention, an existing graft product can be reinforced or reinforced by assembly of different types of graft materials into an assembled product. One example of such a reinforced product is a spongy wedge, block, dowel, etc., in which cortical bone reinforcement pins are inserted. As a result, those skilled in the art will appreciate from the present disclosure that different portions of tissue can be assembled to create a complete graft implant. In addition, the present invention provides an assembled implant product comprising any one or combination of allograft material, autograft material, xenograft material, synthetic material, metallic material, and the like. Further, the assembled implant or component pieces that are combined to form the assembled implant can be pre-processed or post-assembled to process any desired biologically active material or non-reactive material. Active materials can be incorporated. Thus, for example, in an assembled bone dowel implant according to the present invention, the assembled bone dowel includes segments of cortical bone secured together by cortical bone pins. Before or after assembly, the graft material is soaked, leached, saturated or coated with bone morphogenic protein (BMP), antibiotics, growth factors, nucleic acids, peptides, etc. Otherwise it is processed.

  The compositions and structures disclosed herein and the compositions and structures claimed herein can be obtained from allograft sources, xenograft sources or autograft sources; And it is also shown to include cortical, sponge-type, or cortex-sponge-type bone tissue, or combinations thereof. As disclosed herein, the compositions and structures disclosed herein, as well as the compositions and structures claimed herein, are mineralized bone, demineralized. Including bone, or a combination thereof. In addition, a preferred pretreatment is to subject the allograft source bone material and the xenograft source bone material to one of the cleaning processes described below: US patent application 09/363. 909 (filed July 28, 1999), related PCT application PCT / US00 / 20629 (filed July 28, 2000 and published as WO 01 / 08715A1), and US patent application 09 / 191,232 (1998 November 11). Filed on May 13).

  In essence, one method for reducing antigenicity (disclosed in US 09 / 363,909 and WO 01 / 08715A1) is hydrogen peroxide or a surfactant (eg, Triton X-100 or sodium dodecyl sulfate (SDS )) Or other chaotropic agents (e.g. urea, guanidinium hydrochloride, Tween, TNBP and mixtures of these agents) to treat the bone material. This is followed by contact with a degreasing solvent (eg, acetone, isopropanol, hexane, or combinations thereof). The main objective is to remove non-collagen proteins from the bone graft material, thereby reducing antigenicity.

  In another method (disclosed in US 09 / 191,232), effective cleaning and passivation (pathogen inactivation) is achieved by continuous decompression and pressurization of the chamber containing the bone graft material. Where these materials are exposed to a cleaning solution / chaotropic solution and these solvents include those disclosed above. This process has been found to improve the penetration of the cleaning solution. Thus, for the bone composition and bone structure disclosed herein and the bone composition and bone structure claimed herein, these pre-treatments are for cleaning and finishing materials. It can be applied to reduce the antigenicity of

  It will be appreciated that variously shaped wafers, blocks, rings, washer-type bone fragments, etc. can be attached to each other in any fixed and biologically acceptable manner. Preferably, the assembled bone fragments are attached to each other by pins, screws, rods, interference fits, thread fits, keyway fits, etc. made from cortical bone. These fixed pieces are machined to an appropriate size, such as in a CNC lathe, and then passed through tapped mating holes in the assembled pieces, or via adjacent pieces assembled by pneumatic means, etc. It is pushed into the drilled hole. In this manner, very strong and tightly compatible implant material pieces can be joined and implanted. This combined piece can be first machined to the desired size and shape prior to assembly, the assembled implant can be machined, or both.

  As noted above, an implant according to the present invention may include assembled cancellous blocks, dowels, etc. recovered from the iliac crest or another suitable site. As is known in the art, due to the cancellous bone wafer-like structure, such implants have low load bearing characteristics. For example, there are reports of literature examples of extrusion, ejection, or collapse of iliac crest wedges, Crown dowels, etc. when utilized in spinal fusions. Nevertheless, the use of cancellous bone is preferred over the use of cortical bone grafts. This is because cancellous bone is more osteoconductive than cortical bone. In accordance with the present invention, a Crown dowel, iliac crest wedge, or cancellous bone block or dowel, etc. is reinforced by insertion of a cortical bone pin therein. In accordance with the method of the present invention, the cortical implant can also be reinforced by the insertion of cortical bone pins therein (prepared implants comprising different segments of cortical bone, cancellous bone or both) are prepared. Including cases). The insertion of the reinforcing pins provides multiple load bearing pillars to the implant. The pin can be made to be pushed out of the surface of the implant to engage the inner surface, the outer surface or both sides of the bone between which the implant is inserted. Thus, in spinal cord implants, pin protrusions can be used to create contact between the implant and the spinal body, thereby preventing extrusion and ensuring conformity of the implant between adjacent vertebrae. Reinforce. The inventors have surprisingly found that about 4.5 mm diameter cortical pins can each support a load up to about 2700 Newtons (160 Mpa). Thus, according to the method of the present invention, multiple pins can be inserted into the implant to produce a load bearing capacity of known characteristics (eg, 10,000 Newtons with the insertion of 5 pins).

  A further advantage of the present invention is that it allows the use of tissue that is currently not amenable to standard retrieval and processing procedures for autografts, allografts or xenografts (eg, ribs, metatarsals, etc.). It is a point to do. Further useful implant materials can be recovered and generated from otherwise unavailable donor tissue. Furthermore, due to the different nature of the various bone segments incorporated into the assembled reinforcing implants of the present invention, various forming methods resulting from CNC lathes or other known procedures can be used for different implant segments. Can be applied. Thus, the cancellous portion of the bone implant can be compression molded and then attached to other portions of cortical bone or cancellous bone adapted according to different or similar principles. Further, due to the ability provided by the present invention to assemble the implant, an unusually sized and dimensioned implant can be prepared and machined. Thus, a 100 mm size implant can be machined, for example, for carpalectomy (otherwise bone stock is used to produce such implant dimensions). If not possible).

  In light of the present disclosure, it is recognized that the present invention provides a wide variety of assembled implants and implant portions: Dowel implants are assembled together by one or more cortical bone pins Containing dowel segments (between about 2 and about 10 segments). The assembled segments may be in close proximity to each other or separated from each other. Such implants retrieve the cortical bone disk, drill it, and if necessary tap holes in it, and insert the shaft of the cortical pin through or into it, as needed. Accordingly, it can be prepared by passing a portion of it to rotate into any tapped hole. Thus, the generated dowel can be tapered or have parallel edges. Further, Dowel, recovered as a cross section across the long bone inner spinal canal, is described in US Pat. No. 5,814,084 (this must be the case because of the penetration of one outer wall into the spinal canal. Can be completed by inserting a cortical pin into it, such as Similarly, if the sidewall is otherwise considered too narrow, a bone “donut” can be attached to the sidewall by a cortical pin. Longer dowels can be prepared by attaching two dowels to each other. A posterior longitudinal interbody fusion implant (PLIF) can be machined from a single piece of cortical bone or assembled from two pieces of bone attached to each other by cortical pins. Bone screws can also be prepared according to the method of the present invention by attaching multiple pieces of cortical bone to each other using cortical bone pins and then machining threads outside the assembled bone pieces. It is further possible that different parts of the assembled implant can be partially or completely demineralized to achieve a level of elasticity or compressibility that would otherwise not be present in cortical or cancellous bone. Will be appreciated from the present disclosure. Having a combination of demineralized and mineralized regions that exist in a single discontinuous piece (ie, segment) or are assembled into a single discontinuous piece (ie, segment) Certain embodiments of the assembled implant have been shown to possess superior properties. Different parts of the bone can also be held on the shaft by a cotter-pin type device.

  According to one embodiment, the segment is a mineralized allograft bone, and this region is in intimate contact on two sides by two regions of partially demineralized allograft bone Can be done. Single-segment demineralized regions can be obtained by conventional methods (for example, by submerging a portion of a segment of mineralized allograft bone in a demineralized acidic solution, Can be formed in accordance with the removal of the mineral matter, leaving Alternatively, larger assembled implant segments that include both mineralized and demineralized areas can be formed and then into multiple segments and subsequently assembled structures or multiple segments. Can be split (eg, cut laterally) and then joined together (eg, by biocompatible adhesive, bone paste, tongue and groove, etc.) to a structure that can be assembled. The term “demineralized” is well known in the art and is defined for the purposes of the present invention as the removal of minerals from a material such as bone (eg, by dissolution in acid).

  As used herein, a “mixed composition segment” is defined to describe a segment of an allograft implant that includes two or more regions having different characteristics and / or properties. For example, a mixed composition segment may include a region containing demineralized bone or mineralized bone adhered to another region containing a synthetic material. Furthermore, “demineralized” identifies both partially demineralized and fully demineralized if either “partially” or “completely” does not precede Note that it is considered to include for the environment. Further, when referring to a particular mixed composition segment, this segment may be described as a “demineralized bone segment comprising a mineralized bone region” and at least one mineralized bone region And is interpreted to mean a segment having at least one demineralized bone region.

  In addition to assembled implants, instruments that can be utilized for insertion of other implants can be conveniently prepared according to the methods of the present invention. Thus, in one embodiment of the present invention, an implant driver is made, where the driving mechanism itself is formed from an assembled cortical pin that pushes into a mating recess in the implant device. The instrument can be rotated against an appropriate load to guide a transplant, such as a spinal cord implant.

  In developing various embodiments of the present invention, one advantageous technical problem is that donor tissue (whether hard tissue, soft tissue, autograft tissue or xenograft tissue). There is a need to develop processes that can be treated in a manner that eliminates the possibility of cross-contamination between tissue segments obtained from different sources. While it is possible to advantageously practice the present invention using tissue from a single donor screened, the scale of the technology and the real economy of commercially viable applications are both effective and reliable. Best achieved by performing the purification process. Ideally, the process is a process that allows multiple segments of soft or hard tissue to be treated simultaneously to facilitate stocking of the implant assembly material according to the present invention. Thus, one preferred method for tissue processing is PCT Publication WO 00/29037 (the disclosure of which is hereby incorporated by reference as if fully set forth herein (and this application The priority of the resulting U.S. patent application is disclosed by this specification for this purpose.) Accordingly, in this aspect of the invention, an assembled autograft tissue implant or xenograft. A process is claimed in which a tissue implant is prepared by treating the tissue in a closed container, in which a different cleaning solution is added to the graft segment and the final implant. Contacted in the presence or absence of sonication, before or after assembly into form and machining, pressure is rapidly varied in the closed solution, deep cleaning, and Interpenetration of the cleaning solvent into the porous implant or tissue gap is achieved.Solutions (including but not limited to surfactant solutions, peroxide solutions, etc.) are used in such procedures. And gamma irradiation known in the art, terminal sterilization with a gaseous sterilant, or other terminal sterilization procedures known in the art to ensure safe implantation of an assembled implant according to the present invention. Used for.

  Referring now to FIG. 1, there is a flow chart showing various elements that can be processed and assembled in accordance with the present invention. Cortical bone pin 100 is used to assemble a series of bone discs 101 into pre-parts 102, which are then machined into the following series of final products: threaded dowel pins (threaded) dowel) 103; small block 104; unique shape 105 (eg, “wedding cake” -like shape) (disks carrying the screws spaced apart from each other leaving a gap 105 ′, into which additional material is inserted. And the discs are held in a fixed relationship with each other by a through pin 100); a tapered dowel pin 106; a screw 107; a smooth cylinder 108; or a large block 109. From this figure, the central concept of the present invention is that tissue (especially bone tissue (eg, cortical bone, cancellous bone, cortical-cancellous bone, parts that can be demineralized (eg, for purposes of this The smaller portions of US Pat. No. 6,090,998, incorporated herein) are machined and these tissue portions are assembled, preferably using cortical bone pins. The assembled tissue piece can be machined prior to assembly, after which the complete implant is ready for implantation during assembly, or the tissue piece is first assembled. The assembled pieces can then be machined into any desired final form, the order of assembly and machining being determined by the particular form of implant required for a particular application. In Figure 1, a series of pre-machined tissue forms are disclosed, which can be conveniently included in a kit for use as required by an orthopedic surgeon. If a specific implant of a specific size is required, the surgeon may select a pre-formed implant segment to fill a specific geometric space and shape in the implant recipient's spine Numerous permutations and combinations of assembly implants are possible based on the pre-machined assembly implants included in such kits, and skilled orthopedists can Those skilled in the art will recognize that the necessary implants can be made when supplied with such kits, and thus preferred kits include bone, cortical bone, sponges. An autograft or xenograft disc (also referred to herein as a “washer” or donut) and press fit the disc onto cortical bone or synthetic shaft or pin or metal shaft or pin Or with a central hole for screwing, the disk can be demineralized, mineralized, or partially demineralized, and desirable in such kits is cortical bone , Cancellous bone, or cortical-cancellous bone plugs, which have at least one (more than one if necessary) through-hole for insertion of a pin therein, oval, square, Rectangular and irregular shapes can also be provided in specific kits for specific applications.Based on the present disclosure, bone paste (eg, according to this specification). Including the bone paste disclosed in WO 99/38543, which is incorporated by reference, to fill any remaining gaps and with the assembled implant, ie, osteoconductive (ie, osteoconductive). It is further recognized that it may be beneficial to implant material), osteoinductive material, or both, as well as materials that aid in attaching the implant to the implantation site. Further, the molded implant can be combined with the assembled implant of the present invention. Preferred molded implants for orthopedic applications are disclosed in PCT Publication WO 00/54821, the disclosure of which is hereby incorporated by reference.

  The assembled autograft can be assembled and distributed from a central location, or it can be assembled at the time of surgery to meet the patient's specific needs as described above. To be noted. In many applications, it is preferable to have a tight and accurate interference fit between the cortical bone pin and the hole in the bone fragment connected by the bone pin. The target range for such an interference fit is 0.001 inch to 0.003 inch (for example, the pin diameter is 0.001 to 0.003 inch larger than the hole diameter and press fit in place. ) However, lyophilizing the pin and other bone fragments causes an unbalanced shrinkage on the pin compared to the hole diameter. That is, the pin shrinks slightly larger than the hole. If not corrected, this results in an interference fit that is less accurate and less acceptable.

  The following method is adapted to solve this problem. Bone pins of the desired diameter (preferably cortical bone pins) are vacuum dried for at least 5 hours. This drying step is preferably performed at room temperature and under a negative pressure of about 100 mtorr. This pre-treatment produces about 80% of the total shrinkage that occurs during lyophilization. The pin diameter is measured and a hole is made in the disc (or other shape to be assembled) using an appropriately sized reamer. The target size of the hole is 0.002-0.0025 inches smaller than the pin diameter after vacuum drying. Preferably, prior to this drilling step, the disk or other shape is kept saturated with moisture in order to maintain a consistent size and subsequent percent shrinkage. After all holes have been drilled, pins and disks or other shapes are assembled and then lyophilized. The resulting assembled autograft has been found to have an interference fit at the desired target area. This method is applicable to the various embodiments described in this disclosure. Alternatively, if the segments are provided in a kit for assembly prior to surgery, the disks and pins are preferably lyophilized in a disassembled state. After lyophilization, the pin diameter is measured and an appropriately sized hole is made in the disc. This allows multiple parts to be provided in the kit, where they can be assembled together so that the friction required to maintain the parts together is achieved. .

  Referring to FIG. 2, two machined bone fragments T and Z are shown, each of which has an external screw structure X and a hole Y into which a pin A is inserted. To form an assembled implant 200. As can be appreciated, the assembled implant 200 includes a gap 201 into which osteogenic material can be inserted before or after implantation. Pin Y can be a metal pin, but is preferably a pin machined from cortical bone. This allows the entire implant to be remodeled over time into autograft tissue, like the vertebrae when the implant 200 is inserted into the intervertebral space. The implant 201 is also shown with a groove 202 in which a driver can be inserted to provide rotational torque for insertion of the implant. An instrument mounting hole 203 is also provided to ensure that the implant remains firmly on the head of the driver means during the surgical implantation process. Naturally, those skilled in the art will recognize that segment Z and segment T can come into close contact with each other, thereby eliminating space 201. In that case, the length of the pin A is modified to avoid unnecessary protrusions, but in some applications, the protrusions may be useful when driving the implant 200 in place. The number of pins used is shown as two in this figure, but may be smaller or larger, which is understood to be experienced once by the implant in situ. Depending on the application, torsional load or degree of compressive load. In some applications, columnar structures are established such that insertion of reinforcing cortical bone pins allows two or more cortical bone pins to withstand the load. This application allows the material to be used in segments that initially cannot withstand substantial loads (this load is created by the cortical bone pin column), and these materials have subsequent structural load resistance. Have the opportunity for bone remodeling to provide.

  FIG. 3 shows an implant assembled from three main segments F, D, and E, which are brought together by pins 300. In this implant, the waffle-type implant segment D is intended to show the use of cancellous bone, which abuts on both sides by cortical bone, which forms segments F and E . A fully assembled implant is shown in FIG. 4, while FIGS. 5, 6 and 7 show a front view and cross-sectional views AA and BB, respectively. Those skilled in the art will recognize from this disclosure that segment F, segment D, or segment E can be demineralized according to methods known in the art. Similarly, all of these segments can be demineralized. If a flexible implant is required, the implant can be assembled and the entire implant can be demineralized. Where flexibility is important in one dimension and a structural support is also needed, one solution is to combine one or more segments of the composite bone graft with at least one mineralized region and at least one mineral. To be a mixed composition segment that includes a quality removal region (described in detail below).

  FIG. 8 shows an embodiment of the present invention in which rectangular bone segments N and G are assembled into the implant 900 shown in FIG. Features 901 and 902, including ridges, teeth, or other external features, are machined into the upper and lower surfaces of the implant to assist in holding the implant once placed in situ .

  FIGS. 10-14 illustrate assembling elements J, H, and I into an implant 1100, which is shown in FIGS. 12-14 in front, cross-section AA and BB, respectively. As can be appreciated, bone element H comprises a waffle-like structure, which is cancellous bone, demineralized bone, polymer composite (eg, poly-L-lactic acid, polyglycolic acid, etc.) It is shown to show you get. Features 1101 and 1102 show external grooves or external teeth that are machined into the upper and lower surfaces of the implant to assist in holding the implant once placed in situ.

  FIGS. 15-18 illustrate the assembly of elements M, K, and L (each of which is a substantially cubic bone element) using pins 1500. FIG. 17 is a plan view showing section AA, which is shown in FIG. 18 and the final assembled implant 1600 is shown in FIG.

  FIG. 19 shows an implant 1900 of a “wedding cake” design assembled from units A-C, fastened together by pins ac. Gap region 1901 is available for filling with osteogenic material.

  FIG. 20 shows an implant 2000, an assembled cervical Smith-Robinson implant, similar to that shown in PCT Publication WO99 / 09914 (incorporated herein by reference). The implant is made from a series of assembled bone fragments 2001 and machined to the desired final shape.

  FIG. 21 shows an implant 2100 assembled from two cortical bone pieces and one cancellous bone piece and pinned together. The implant has an anterior height H1, which is less than the posterior height H2, so that, for example, during lumbar posterior intervertebral implant fixation procedures, accurate spinal curvature retention is maintained during implantation. It becomes possible. Upper feature 2101 and lower feature 2102 prevent release of the implant once placed in situ.

  FIG. 22 shows an implant 2200 assembled from a series of sub-implant pieces 2201. The implant may include cancellous bone 2202 segment, as well as cortical bone 2203 segment and cortical bone pin 2204.

  FIG. 23 shows a tapered dowel 2300 by assembling a bone dough 2301 in the shape of a “donut” or “disk” or “washer” on the cortical long shaft 2302 by using washer pieces of different diameters. Showing formation. Although this figure shows only two discs, a continuous dowel is formed by using a disc of increasing diameter between each end of the cortical long shaft 2302. In FIG. 24, FIG. 24A is a bone dowel 2400 (eg, as disclosed and claimed in US Pat. No. 5,814,084, which is incorporated herein by reference). Bone dowels are shown to be “out of specifications” due to one side wall of the bone being too narrow or missing. This is repaired in FIG. 24B according to an embodiment of the present invention by the incorporation of cortical bone pin 2401, an allograft or xenograft, to form a complete bone dowel. In this manner, valuable biological material that may otherwise be unsuitable for a particular application can be protected for use by using the methodology of the present invention.

  In FIG. 25, a similar procedure for protecting the dowel 2500 is shown, whereby the pin 2501 is driven into the center of the dowel 2500 to reinforce the dowel 2500 in the longitudinal direction. Further, if the dowel end cap 2503 is too narrow and “out of specification”, the end cap is reinforced by pressing a cortical bone disc 2502 into the distal end of the pin 2501.

  In FIG. 26, a series of cancellous implants 2600 are reinforced by encapsulating them in a series of cortical pins 100. Each 2 mm diameter cortical pin was found to support an axial pressure load of about 2000 N. Thus, a desired height and pressure loaded cancellous implant that is essentially arbitrary can be assembled in this manner by attaching cortical bone pins to several layers of cancellous. Of course, based on this disclosure, one of ordinary skill in the art will understand that other materials may be included in such “sandwiching” bone material.

  This cancellous can be immersed in a solution containing, for example, but not limited to, growth factors including: bone morphogenetic protein, growth factor, fibroblast growth factor, platelet derived growth factor, cartilage derived bone development protein Stem cells (eg, mesenchymal stem cells), proosteoblasts, antibiotics, anti-inflammatory compounds, anti-neoplastic compounds, nucleic acids, peptides, and the like. Those skilled in the art will also understand that layers of cortical bone can be included, and layers such as biocompatible synthetic polymers can also be included in the laminated bone graft. Various shapes can also be assembled using, for example, circles, ellipses, squares, etc. as required for a given application.

  In a further aspect of the invention, the assembled implant is snapped into the implant site using a screwdriver that is driven with a cortical pin and engages the cortical bone pin with the purchase site on the implant. Thus, for example and without limitation, the driver engages with the hole in the assembled allograft, thereby providing a site for torqueing the implant in place. A handle may be provided that protrudes the cortical pin.

  In a further embodiment according to the present invention, an assembled cortical bone block, or cortical cancellous block, or cortical bone material, cortical-cavernous material, cancellous material as described elsewhere herein. Bone blocks composed of a combination of materials and / or synthetic materials are assembled using soft tissues (eg, tendons, ligaments, skin, collagen sheets, etc.) that are driven with wedges or pins, ( A graft is created that resembles a naturally occurring tissue site (such as the bone-tendon interface) found in the patella. Such combination implants allow reconstruction of sites such as the anterior cruciate ligament (ACL) or the posterior cruciate ligament (PCL). According to one embodiment of the present invention, the ligament or tendon or skin or collagen sheet membrane is pinned between adjacent blocks of cortical bone. Thus, various implants (eg, known under-supply bone-tendon-bone implants) include ligaments, tendons, demineralized bone, and the like, with ligamentous tissue anchored therebetween. Can be replaced by an assembly of implants, including assembled bone blocks. Referring to FIG. 27, an implant 2700 is an upper bone block 2701, a lower bone block 2702, and a wedged flexible tissue (eg, ligament or tendon or demineralized bone 2704, these An example of an embodiment of the present invention is shown, all assembled from a cortical bone pin 2703 or other pinning pin). This upper bone block 2701 is composed of three bone segments (2701a-2701c), which are pinned together by pins 2715. Of course, one of ordinary skill in the art will understand based on this disclosure that other shapes of bone blocks (eg, circular bone blocks and other types of soft tissue and hard tissue combinations may be assembled in accordance with this disclosure. However, the example of such an implant 2700 can be used instead of the need to collect a bone-tendon-bone implant obtained from a cadaver knee (this tissue is under-supplied).

  Another variation of this embodiment is at least one made from a substantially synthetic material bound to a tendon-like section of ligament, tendon, skin or collagen supplied in an allograft, autograft or xenograft. To build a bone-tendon-bone type implant consisting of two blocks. Yet another variation is to construct a bone-tendon-bone type implant composed of synthetic tendon-like material attached to one or both end blocks, where the block is an allograft. The bone graft is composed of autograft or xenograft bone and the block is a single piece or assembled by multiple segments. Examples of synthetic materials are not meant to be limited thereby, but nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactide, poly (L-lactide) (PLLA) ), Poly (D, L-lactide) (PLA), poly (glycolide) (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co-) Glycolide) (PLA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly (phosphazene), poly (phosphazene) D, L- It consists of cutide-co-caprolactone (PLA / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphate ester), polyanhydride, polyvinyl alcohol, hydrophilic polyurethane. A biocompatible substance selected from the group. Some of these materials are biodegradable and can be used in combination with each other to form a synthetic section of the graft.

  Another aspect of the invention is an allograft segment in which at least one region has been mineralized and at least one region has been demineralized. For example, FIG. 28 shows an allograft unit 2800, which has a central mineralized region (2801) and two demineralized regions (2802 and 2803), and these two One of the areas is on either side of this mineralized area. Two holes 2804 penetrate the allograft segment 2800 from the top 2805 to the bottom 2806. As described above, these holes 2804 pass through pins, dowels, or other coupling means through this hole, such that two or more allograft segments are aligned and coupled together. Used to assemble segments.

  One way to generate this segment is to start with a fully mineralized piece of the allograft of the shape shown in FIG. One aspect, such as represented in FIG. 28 as 2802, is described (eg, as described above in this application until it is at the desired level of mineral removal for allograft segment 2800 purposes. E) Subject to appropriate acid mineral removal regimen. The opposite side 2803 is then subjected to the above regimen as well. The area exposed to this mineral removal regimen is immersed in a suitable solution to remove acid and other components that may be toxic, inflammatory, or cell infiltration inhibitory. The central mineralized area does not contact the acid solution of this regimen. This resulting segment is referred to as a mixed composition segment (“MCS”). As described above, this is combined with other segments to form an assembled allograft.

This mineral removal regime is varied based on the desired result. In one example
Central demineralized area blocks the outer surface (side and top and bottom surfaces close to these sides) of the bone cylinder, allowing acid solution exposure only to the central circular area To. In this and other exposure regimens, the demineralization transition region is blocked with the target region (designed to be mineralized) of the bone cylinder (subject to demineralization) Where the degree of mineralization varies from an exposed and demineralized area to an unexposed mineralized area. The extent of this transition region can vary and can be adjusted somewhat by the mineral removal regimen to meet the particular application for the implant.

  An alternative to producing allograft segments (eg, 2800) is to prepare one or more demineralized areas and assemble them with one or more mineralized areas. This assembly is both stable using the means described above. This is referred to as an assembled mixed composition segment (“AMCS”), which can be further combined with other segments to form larger assembled allografts.

  The degree of mineral removal is accompanied by increased exposure to acid (time, acidity, or solution, solution change, or any combination) resulting in a more demineralized, more flexible material Note that it is extensive. Thus, the implant or implant area can be partially demineralized, where some mineral remains and a range of flexibility exists. Alternatively, the implant or implant area can be completely demineralized, where the mineral is essentially removed and there is maximum flexibility. As mentioned, during the demineralization of one region of MCS, a transition region can occur between the demineralized region and the adjacent region of mineralized bone material.

  Accordingly, an allograft segment can be formed by any of the means as described above with respect to FIG. 28 in combination with one or more partially demineralized areas or one or more fully demineralized areas. Or may consist of one or more fully mineralized regions used in combination with a combination of partially demineralized and fully demineralized regions. The arrangement in FIG. 28 is not meant to be limiting and includes two or more regions or two or more types of allografts (mineralized allografts, partially demineralized allografts, completely It merely illustrates the concept of forming a demineralized allograft) or assembling into a single allograft segment. Accordingly, a wide variety of geometries can be made or assembled.

  Allograft segments as described above can be used in combination with other allograft segments as illustrated in FIG. FIG. 29 shows a first segment 2901 that is fully mineralized and a second segment 2903 that is also fully mineralized. Positioned between these segments is a mixed allograft segment 2902 as shown in FIG. Two pins 2904 are used to stabilize these three segments together. Once assembled, this allograft assembly can be used in patients who require some flexibility in the AA dimension. Such flexibility is primarily provided by the flexibility of the partially or fully demineralized lateral region of the mixed composition allograft segment 2904. Further flexibility may be provided by the flexibility of the pins 2904 and the space 2905 between these segments.

  This flexibility is advantageous after manipulation by reducing the potential area of high pressure between the allograft implant and the adjacent autologous bone structure.

  Another potential advantage for certain procedures and implants is that the demineralized or partially demineralized area rebuilds more quickly and / or more strongly than the mineralized bone area. obtain. However, this mineralized bone region provides structural support to transfer loads during the demineralized or partially demineralized region reconstruction.

  Also, as described in US Pat. No. 6,090,998 and its divisional application, the demineralized or partially demineralized region of the implant simulates joint flexibility. May provide the flexibility used to.

  The present invention is specific and uniform based on the use of MCS and / or AMCS positioned in a specific orientation relative to the structure in the patient into which other segments of the assembled allograft and the graft are implanted. It is further noted that an implant fabrication having a complex, flexible or “shock absorbing” property pattern is provided. One example of this is shown in FIG. The assembled allograft 3000 comprises two MCS (3001 and 3002) that are oriented about 60 degrees apart (and about 120 degrees from the second face) with respect to each other. Yes. The first MCS (3001) allows shock absorption in the plane defined by AA, and the second MCS (3002) allows shock absorption in the plane defined by BB. This allows for complex shock absorption / flexibility patterns. MCS 3001 and MCS 3002 are joined by a single pin connector (not shown) that passes through hole 3003. This assembled allograft may comprise additional segments that are not MCS or AMCS, in combination with MCS or AMCS. Variations in design and construction arise from the specific need for specific techniques in the art regarding implants and design or assembly means. Such variations are within the scope of the invention disclosed and claimed herein.

  With respect to the assembly of AMCS, one line of the construct should be assembled together to enclose and / or support separately prepared areas that form segments with the synthetic scaffold. For example, three regions (two are demineralized and one in between is mineralized) (eg, FIG. 28) are further processed around this assembled three regions. Collagen sheet. Also, rigid or semi-rigid composite structures can be used as described above. The auxiliary material should provide additional strength and reduce the adhesive strength required for the surface between the areas of AMCS.

  Another aspect of the invention is the use of synthetic segments and / or scaffolds with assembled allografts. Here, the assembled allograft is composed of any combination of one or more of each of the following segments: mineralized bone; partially demineralized bone; fully demineralized Bones; or MCS or AMCS of these materials. One or more segments of the assembled implant described herein can be replaced by a synthetic segment. Furthermore, the synthetic material can be in the form of various scaffolds used with one or more of the assembled segments. The synthetic segment or scaffold can be composed of a variety of materials, including stainless steel, titanium, cobalt chromium-molybdenum alloy, and one or more member plastics selected from the group consisting of: But are not limited to: nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactic acid, and combinations of one or more bioabsorbable polymers.

  Particularly suitable biodegradable polymers for use in the present invention include poly (L-lactide) (PLLA), poly (D, L-lactide) (PLA), poly (glycolide) (PGA), poly (L-lactide). -Co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co-glycolide) (PLA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS) ), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly (phosphazene), poly (D, L-lactide-co-caprolactone) (PLA / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphoester) and polyanhydrides And the like. Other suitable materials include hydrogel, gelatin, collagen, protein, sodium alginate, karaya gum, guar gum, agar, algin, carrageenan, pectin, xanthan, starch-based gum, cellulose hydroxyalkyl, depending on the specific application Examples include ethers and ethyl ethers of cellulose, sodium carboxymethyl cellulose, polyvinyl alcohol, and hydrophilic polyurethanes.

  For example, a synthetic sheet can be used to wrap around an MCS or AMCS that supports bone growth. Alternatively, the synthetic scaffolds can be rod-like or rod-like, and these pass through in-line holes in each segment. Alternatively, the synthetic scaffold surrounds the bulk of each segment, the bulk of the demineralized segment, MCS or AMCS with flexible regions that require structural support in the particular application in the patient in need thereof, or It can be in the form of a wrapping frame. This can be used, for example, to add structural integrity to one or more segments or to add structural integrity around one or more segments. At least one of the one or more segments has a high percentage of demineralized bone or there is a need for such additional structural support. An example of a synthetic scaffold design (which is not meant to be limiting) is shown in FIG.

  Another aspect of the present invention is an assembled graft implant formed from at least three segments that interlock along adjacent edges. The shape of each segment is such that during the final assembly, the major surface of each segment is not flush with the other segments. For example, the segments do not exist in parallel with each other. For example, FIG. 32 shows a generally annular graft implant 3200 with four pieces assembled. It is made from segments 3201, 3202, 3203 and 3204. Each segment has a male edge 3205 and a female edge 3206, which are designed to mate with adjacent edges. One male edge slides to the female edge of an adjacent segment, and the process continues with the other edge to complete the desired assembly. When the edge joint is interlocked, the joint holds the segments together, as shown in FIG.

  In a preferred embodiment, the assembly of three or more segments results in the formation of a central channel. The center channel 3207 is shown in FIG. The central channel can be filled with osteogenic material or serve other purposes.

  The interlock edge is of a shape known to those skilled in the art and provides an interlocking joint. While not intended to be limiting, examples of matable fitting designs (e.g., shapes in which one part fits around or fits around another part) include a ball and socket (shown ), Scallops, and mortise bonds (eg, dodge).

  Also, if a part of the recipient's body needs to remain intact, it must still be enclosed in a structural support or provide a protective barrier, The inventive segment is used and does not really interlock, as the edge is defined above, but once along the edge to the female edge of the male edge, rather than slipping from one end. With sufficient tolerance to allow direct insertion of This facilitates this assembly around the structural support or the part that needs protection. If desired, one or more bands of elastic material are wrapped around the assembled structure to increase rigidity and / or other means known in the art are used to interlock. Adhesion at the joint (synthetic adhesive, bone paste, screw) can be increased.

  Another interlocking embodiment is two arcuate segments, each having two edges of opposing interlocking edges. This edge is interlocked to preferably form an annular or truncated annulus with a central channel therein. When the arc is semicircular, the assembled implant is tubular. The example is not meant to be limiting, but is shown in FIG. 33, where segment 3300 is interlocked with segment 3310, thereby forming channel 3320. The two embodiments shown include different interlock configurations 3330.

  Referring to FIG. 34, another interlock embodiment of the assembled allograft is shown as 3400, whose final cross-sectional shape is “T” or “Cross”. This embodiment constitutes two individual segments 3401 and 3402, which have a longitudinally defined slot 3405 thereon. The segment thus comprises a body portion 3406 and a grooved portion 3407. When this segment is assembled, the segment interlocks the pieces 3401 and 3402 together to form a bone block. As shown, the assembled implant shows four fins 3410a-d that extend from the center point 3403 in all directions. The preferred diameter of the assembled allograft 3400 is about 2.5 mm and the preferred diameter can range from about 2.0 to 12.0 mm. This assembled allograft is used for various applications. Here, bone blocks are used. Preferably, embodiment 3400 is used with a bone-tendon-bone graft. Two preferred flexible bands (natural or synthetic) when used in a bone-tendon or bone-tendon-bone application are tied to the top of embodiment 3400. Here, one band contacts fins 3410a and c, and the second band contacts fins 3410b and d. When the bone block 3400 is placed in a channel (eg, a bone tunnel formed in a patient), the two bands are compressed against the fins 3410a-d and thereby secured in place. Alternatively, the fin edges may be provided with teeth or otherwise irregular to further prevent slipping of the band.

  The interlock segment can be made from cortical bone, cancellous bone, or a combination of cortical and cancellous bone. The segment can be allograft material or xenograft material and is preferably processed to reduce antigenicity. Depending on the requirements of this application, the interlock segment can be mineralized, demineralized, mixed composition, synthesized, or a combination thereof. Synthetic materials (eg, those described above) can also be used in forming segments or in addition to interlocking edges to contribute to the connection of the segments.

  Based on this disclosure, one of ordinary skill in the art will further understand that the cortical bone pins disclosed herein may have the features defined thereon for various applications. For example, although not intended to be limited, the shaft stops so that other pieces of bone that can be inserted there can only travel a certain distance under the shaft before encountering the stop. May comprise a part. The shaft can also be provided through the hole or can be provided to allow insertion of a spigot pin or the like. Further, the cortical bone shaft can be demineralized, mineralized, or partially demineralized. In one particular embodiment, the edge of the cortical shaft comprises a short distance of tapered cannula insertion at the longitudinal end of the shaft. In this way, the screw can be driven into the cannula insertion to hold the element inserted relative to the shaft relative to the shaft. In order to fit the screw, the screw end that can withstand cannulation can be partially demineralized so that upon insertion of the retaining screw, the shaft end is not crushed but provided to the shaft. To expand to the increasing diameter of the screw. Of course, in certain applications, it may be desirable for the cortical pin to be cannulated through the entire length of its longitudinal axis. However, care should be taken that this does not unduly weaken the overall compressive or torsional strength of the assembled implant. This can be addressed by including a non-cannulated pin with a cannulated pin. Cannulated pins are used with sutures etc. to hold the implant in a specific direction until fusion with the adjacent bone is advanced to a degree sufficient to stabilize the implant without suture Can be done. It is understood from the present disclosure that implants that are traditionally made from metal can be made by assembling bone fragments. In addition, an advantage of an implant assembled in accordance with the present invention is that the components of the assembled implant can be derived from a variety of anatomical structures, and thus normally the surrounding limitations are that of a particular donor. Results from having to obtain the graft from a specific anatomical source. Not only can the components be obtained from different anatomical structures, but different donors can obtain various components for assembly into a single implant. The net result is maximizing the contribution of contribution and preserving valuable tissue sources. As mentioned above, the ability to pool tissues from different sources, to some extent important, to prevent any contamination of recipients with pathological or antigenic factors, Depends on ability to process a portion of tissue taken from a donor. A further advantage of the present invention is that due to the anatomy, different implants with limited height or width through which the implant can be guided form an implant of essentially any desired size. Can be pinned together. In this manner, an inventory of building blocks in combination with appropriate assembly pins (which may or may not be threaded) is inherent in the course of a given surgical procedure. Useful for providing implants of any size. In accordance with this embodiment of the invention, for example, any desired height of cervical Smith-Robinson (CSR) can be generated by adhering two or more existing CSR implants along with cortical bone pins. This is preferably accomplished using two machined CSRs of known height so that the desired overall height is achieved when added together. The two CSRs are stacked and the drill holes are machined through the CSR body, after which the cortical bone pins are pushed through the holes so machined. Preferably, the diameter of the pin is slightly larger than the diameter of the drilled hole, so that a close indentation is achieved.

  From this disclosure, it is further understood that an implant according to the present invention can be assembled by a surgeon in an operating room using a pre-formed implant from a kit. It is further understood that the assembled implant can be adhered to each other using any of a number of biologically acceptable adhesives, pasta agents, and the like. In one such embodiment, the assembled implant is identified as non-toxic using polymethyl-methacrylate adhesive, cyanoacrylate adhesive, or any other adhesive known in the art. As long as it is assembled using such an adhesive. In forming an assembled implant in accordance with the present invention, it is not necessary, but acceptable, to include an interlocking surface on the adjacent surfaces of the implant segments that are assembled together. Where such a feature is included, it is preferred that the adjacent portion is complementary, and as a result, the protrusions of the first surface are more closely matched to the conformal score on the adjacent surface. Such adjacent portions provide torsional and structural strength to the assembled implant and help reduce stress criteria for the cortical bone pins used to assemble the implant.

  In accordance with U.S. Pat. No. 6,025,538, the composite system can be used in such a manner that the holes are aligned at an angle to the mating surface such that the holes are tilted relative to the plane of each mating surface. It is disclosed to ensure that a hole is provided in the mating surface of the object. This is not necessary according to the invention.

  According to US Pat. No. 5,899,939, layers of bone are juxtaposed, but mechanical fixation of the various layers to each other (eg, cortical bone pins disclosed herein) is not provided .

  Although the present invention has been described generally, including its method of manufacture and use (including its best mode), it will be appreciated that many variations on the principles described herein may be achieved. The merchant understands. Accordingly, the specific parts of the description and the accompanying drawings should not be construed to limit the scope of the invention to those specific parts. Rather, the scope of the present invention should be evaluated with reference to the appended claims.

Attached to the present disclosure are a number of sketches, which represent a wide variety of assembled implants that can be prepared and used in accordance with the present invention.
FIG. 1 is a flow chart showing the formation of various subcomponent parts of an implant that are assembled according to the present invention, from which implants and kits containing these parts can be formed in accordance with the present disclosure. It is. FIG. 2 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 3 provides a schematic diagram of an implant assembled in accordance with the present invention. FIG. 4 provides a schematic diagram of an implant assembled in accordance with the present invention. FIG. 5 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 6 provides a schematic diagram of an implant assembled in accordance with the present invention. FIG. 7 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 8 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 9 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 10 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 11 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 12 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 13 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 14 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 15 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 16 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 17 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 18 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 19 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 20 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 21 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 22 provides a schematic view of an implant assembled in accordance with the present invention. FIG. 23 shows the assembly of dowels from component pieces. FIG. 24 shows implant enhancement using cortical bone pins. FIG. 25 shows implant enhancement using cortical bone pins and cortical bone discs. FIG. 26 shows the enhancement of cancellous bone implants using multiple cortical bone pins. FIG. 27 illustrates the formation of an assembled implant that includes soft and hard tissue. FIG. 28 shows a segment that includes a central mineralized region and a demineralized region. FIG. 29 shows the placement of the segment of FIG. 28 positioned between two mineralized implant segments. FIG. 30 illustrates an alternative embodiment that includes more than one segment having mineralized and demineralized regions. FIG. 31 shows an embodiment of the intended assembled implant supported by the skeleton. FIG. 32 shows a further embodiment that includes segments secured together via a friction fit. FIG. 33 shows a two-segment assembled implant secured together via a friction fit. FIG. 34 illustrates an embodiment that includes two segments that interlock together in a reverse crossing configuration.

Claims (101)

  A method for producing an autograft, allograft and xenograft implant, comprising assembling such an implant from a smaller piece of graft material to produce a larger graft. A method comprising the step of forming an implant product.   A kit comprising an assemblable part of an autograft, allograft and xenograft implant, wherein the kit is assembled from a smaller piece of graft material and larger. A kit for forming an implant implant product, wherein the product can be formed in the course of a surgical procedure to accurately match the requirements of a given patient or procedure.   A method of reinforcing or reinforcing an autograft, allograft, and xenograft implant, comprising assembling such an implant from a smaller piece of graft material to produce a larger graft. A method comprising the step of forming an implant product.   The method of claim 3, wherein the reinforced product is spongy and a reinforcing material is inserted into the product.   The method of claim 4, wherein the reinforcing material comprises cortical bone.   A graft implant assembled into an assembled implant comprising any one or combination of autograft material, allograft material, xenograft material, synthetic material, metallic material, the implant A graft implant that is assembled into a single graft by use of a reinforcing material to hold the components of the graft material together.   The graft implant of claim 6, wherein the reinforcing material comprises cortical bone.   Any one or combination of the autograft material, allograft material, xenograft material, synthetic material, metal material has been pre-processed by the process, and the process bones the associated non-bone foreign material Removing from the graft to provide a cleaned bone graft, contacting the cleaned bone graft with a degreasing solution to provide a cleaned defatted bone graft, and 7. A graft implant according to claim 6, which is a process comprising contacting the cleaned defatted bone graft with a chaotropic agent to remove non-collagen protein or non-structural collagen protein.   9. The graft implant of claim 8, wherein the chaotropic agent is urea, guanidinium hydrochloride, Tween, Triton X-100, TNBP, SDS and combinations of these agents.   Any one or combination of the autograft material, allograft material, xenograft material, synthetic material, metal material has been pretreated by a process, the process being cleaned, perfused, and inert 7. The implant of claim 6, comprising a process of compositing, wherein the process comprises periodic exposure of the implant to elevated positive or negative pressure and reduced positive or negative pressure. Transplant.   The cleaning solution used during the cleaning process is sterilized water, Triton X-100, TNBP, 3% hydrogen peroxide, water-miscible alcohol, saline solution of povidone iodide, ascorbic acid solution, aromatic Or selected from the group consisting of aliphatic hydrocarbons, ethers, ketones, amines, ureas, guanidine hydrochlorides, esters, glycoproteins, proteins, saccharides, enzymes, gaseous acids or peroxides, and mixtures thereof, The graft implant of claim 10.   7. The graft implant of claim 6, wherein the assembled implant is pre-treated or post-assembled to incorporate biologically active or inert material.   An implant comprising segments of cortical bone, cancellous, cortical cancellous, or combinations thereof, wherein the segments are pinned together by a cancellous pin, where before or after assembly The graft material is immersed, injected, infiltrated, coated with bone morphogenic protein (BMP), antibody, growth factor, nucleic acid, peptide, or combinations thereof, or Implants that are processed in other ways.   Crowd dowels, iliac crest wedges, or sponges with assembled cancellous blocks or dowels taken from the iliac crest or another suitable site and reinforced by inserting cortical bone pins inside 7. Implant according to claim 6, forming a quality block, dowel.   The implant of claim 6, comprising a cortical bone implant reinforced by inserting at least one cortical bone pin therein.   The implant of claim 6, comprising an assembled implant comprising different segments of cortical bone, cancellous, or both.   The implant of claim 6, comprising an assembled implant comprising different segments of cortical bone, cancellous, demineralized cortical bone or cancellous, synthetic material, and combinations thereof.   The implant of claim 17, wherein insertion of the reinforcing pin provides a plurality of load bearing pillars to the implant.   19. The implant of claim 18, wherein the pin protrudes from the surface of the implant to engage the lower, upper, or both surfaces of the bone into which the implant is inserted.   20. The implant of claim 19, which is a spinal implant.   20. A bone graft cancellous portion, said portion being fixed to cortical bone or other cancellous portion that is compression molded and then machined according to different or similar principles. The described implant.   The implant of claim 6 in the form of a tapered dowel.   A method of repairing a bone graft comprising the step of inserting at least one cortical bone pin therein.   24. The method of claim 23, further comprising securing the bone fragment to an existing bone graft by securing a bone fragment to the cortical bone pin.   The method of claim 1 for making a device for insertion of another implant.   25. The method of claim 24, wherein the method is an implant driver.   A method for recovering an implant that does not meet manufacturing specifications, wherein the method inserts at least one cortical bone pin into the site to reinforce the site, so that the at least one cortical bone pin and In combination, the method wherein the implant meets manufacturing specifications.   An assembled implant, the first bone pinned to the second bone segment by a flexible tissue secured between the first bone segment and the second bone segment An assembled implant comprising segments.   30. The assembled implant of claim 28, wherein the first and second bone segments are secured together by at least one cortical bone pin.   An assembled graft implant comprising two or more individual segments fixed together, the implant comprising at least one demineralized bone segment and at least one mineralized bone An assembled graft implant comprising a segment.   31. The assembled implant of claim 30, wherein the at least one demineralized bone segment comprises a mineralized bone region.   31. The assembled graft implant of claim 30, wherein the demineralized segment or mineralized segment is made from cortical bone, cancellous, or both.   An assembled graft implant comprising two or more individual segments fixed together, the implant comprising at least one synthetic segment and at least one demineralized bone segment; Assembled graft implant.   34. The assembled graft implant of claim 33, wherein the demineralized bone segment comprises a mineralized bone region.   The synthetic segment is stainless steel, titanium, cobalt chromium-molybdenum alloy, nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactide, poly (L-lactide) (PLLA). ), Poly (D, L-lactide) (PLA), poly (glycolide) (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co-) Glycolide) (PLA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly (phosphat) ), Poly (D, L-lactide-co-caprolactone) (PLA / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphatase ester), polyanhydride, polyvinyl alcohol, 34. The assembled graft implant of claim 33, composed of a combination of hydrophilic polyurethane and one or more bioabsorbable polymers.   The at least one synthetic segment comprises a first end and a second end, wherein the demineralized bone segment or the mineralized bone segment is the first end or the second end. 34. The assembled graft implant of claim 33 attached to the ends of the two.   An assembled graft implant comprising two or more individually secured individual segments, the implant comprising at least one synthetic segment and at least one mineralized bone segment Graft graft.   The synthetic segment is stainless steel, titanium, cobalt chromium-molybdenum alloy, and nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactide, poly (L-lactide) ( PLLA), poly (D, L-lactide) (PLA), poly (glycolide) (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co -Glycolide (PLA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly ( Sphazene), poly (D, L-lactide-co-caprolactone) (PLA / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphatase ester), polyanhydride, polyvinyl alcohol, 38. The assembled graft implant of claim 37, comprising one or more member plastics selected from the group consisting of a hydrophilic polyurethane and a combination of one or more bioabsorbable polymers.   An assembled graft implant comprising two or more individual segments secured together, wherein the assembled graft comprises at least one demineralized bone, mineralized bone, At least one segment composed of a mineralized region or mineral material having a mineralized region, and a demineralized bone, mineralized bone, mineralized, fixed to the segment An assembled graft implant comprising demineralized bone having a region of at least one other segment composed of synthetic material.   A graft segment configured for assembly with at least one other segment, the graft segment comprising at least one mineralized bone region and at least one demineralized bone region. A graft segment comprising.   41. The implant segment of claim 40, wherein the mineralized bone region is attached to or integral with the demineralized bone region.   The graft segment is integral with a central mineralized bone region, and at one or more sites that are integral with the central mineralized bone region and surround the mineralized bone region. 41. The implant segment of claim 40 comprising at least one demineralized bone region located.   A mixed composition segment configured for assembly with at least one other segment, wherein the mixed composition segment is in a separate region composed of mineralized bone, demineralized bone or synthetic material A mixed composition segment comprising a region composed of mineralized bone, demineralized bone or synthetic material that is attached or integral.   44. The mixed composition segment of claim 43, further assembled with at least one other graft segment.   A method for the production of a mixed composition segment for autograft, allograft and xenograft implants comprising the step of demineralizing an area of a mineralized bone segment with a mineral removal solution. Contacting the region for a time sufficient to achieve a desired level of mineral removal.   46. A sufficient amount of the demineralization solution is removed from the first region to prevent a toxic or immune response to the segment upon implantation into a patient in need of transplantation. The method described.   The contacting is repeated for at least one additional region, and the removing is made for the at least one additional region at the same time or at a different time than the time for the first region; 48. The method of claim 46.   46. A mixed composition segment made by the method of claim 45.   46. A mixed composition segment made by the method of claim 45, wherein at least one region of the mixed composition segment is mineralized bone, and at least one region of the mixed composition segment is A mixed composition segment that is demineralized bone.   46. A mixed composition segment made by the method of claim 45, wherein one region of the mixed composition segment is mineralized and one or more regions of the mixed composition segment are mineral materials. A mixed composition segment that has been removed, wherein the one or more regions surround or sandwich the mineralized bone region. A method for producing a mixed composition segment for autograft, allograft and xenograft implants comprising:
a. Contacting a first piece of graft material comprising bone with a mineral removal solution for a time sufficient to achieve a desired level of mineral removal on the first piece; and b. Bonding or otherwise adhering a portion (region) of the first piece of demineralized graft material to a second piece of graft material, comprising: The second piece of graft material has been mineralized, demineralized, or synthesized so that the bonded or intimate attachment results in a single integral mixed composition segment. Resulting step; and c. If necessary, a sufficient amount of the demineralization solution is removed from the first area to prevent a toxic or inflammatory response to the segment upon implantation into a patient in need of transplantation. , Process,
Including the method.   Step (a) is repeated for at least one additional piece, and step (b) is applied to each at least one additional piece to form a multi-piece (multi-region) mixed composition segment. 52. The method of claim 51, repeated.   52. A mixed composition segment made by the method of claim 51.   52. The method of claim 51, wherein at least one region of the mixed composition segment is mineralized bone and at least one region of the mixed composition segment is demineralized bone. Mixed composition segment.   One region of the mixed composition segment is mineralized bone, and one or more regions of the mixed composition segment are demineralized bone, wherein the demineralized bone 52. The mixed composition segment made by the method of claim 51, wherein the region surrounds or sandwiches the mineralized bone region.   A kit comprising an autograft, an allograft, an xenograft assembleable portion, and a synthetic segment, the kit comprising a smaller piece of graft material mixed with the pre-determined product A kit that can be formed in the course of a surgical procedure to accurately match the requirements of a patient or procedure and that includes at least one mixed composition segment around the assemblyable portion.   A method of reinforcing or reinforcing a mixed composition segment for autograft, allograft and xenograft implants comprising assembling the mixed composition segment from smaller pieces of graft material. Forming a larger mixed composition segment.   58. The method of claim 57, wherein the mixed composition segment comprises cancellous in combination with demineralized bone.   58. The method of claim 57, wherein the mixed composition segment comprises cortical bone in combination with demineralized bone. An implant comprising segments of cortical bone, cancellous, cortical cancellous, or a combination thereof, pinned together by cortical bone pins, wherein the implant before or after assembly The material is immersed, infused, infiltrated, coated or otherwise in a bone morphogenetic protein (BMP), antibody, growth factor, nucleic acid, peptide, or combinations thereof Wherein the at least one of the segments is a mixed composition segment or demineralized bone.
  An assembled implant comprising a first bone segment pinned to a second bone segment and secured between the first bone segment and the second bone segment; An assembled implant comprising flexible tissue, wherein the first bone segment is a mixed composition segment.   Assembled implant bone graft comprising at least two individual segments joined together and a synthetic scaffold material, wherein the synthetic scaffold material passes through the segment and / or An assembled implant bone graft that encloses and thereby provides structural support for at least one of the at least two individual segments. Assembled bone graft, the following:
a. A first graft segment comprising at least one mineralized bone region and at least one demineralized bone region; and comprising at least one hole;
b. At least one other graft segment comprising at least one hole; and c. At least one connector;
With
d. An assembled bone graft whereby the first graft segment and the at least one other graft segment are physically coupled by the at least one connector.   The first graft segment and the at least one other graft segment pass through at least one pin, rod, bar, post, or other at least one hole in the first graft segment. 64. The bone graft of claim 63, wherein the bone graft is physically coupled by a straight connector and the hole is positioned to align with the at least one hole of the other graft segment.   And further comprising a synthetic support structure covering all or a portion of the composite bone graft, whereby the synthetic support structure supports a load otherwise imposed on at least one of the graft segments. 64. The bone graft of claim 63.   The synthetic support structure includes stainless steel, titanium, cobalt chromium-molybdenum alloy, and nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactide, poly (L-lactide). ) (PLLA), poly (D, L-lactide) (PLA), poly (glycolide) (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide) -Co-glycolide) (PLA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly ( Sphazene), poly (D, L-lactide-co-caprolactone) (PLA / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphatase ester), polyanhydride, polyvinyl alcohol, 68. The composition of claim 65, comprising a biocompatible material selected from the group consisting of one or more member plastics selected from the group consisting of a hydrophilic polyurethane and a combination of one or more bioabsorbable polymers. Bone graft.   A graft implant comprising any one or combination of autograft material, allograft material, xenograft material, synthetic material, and metal material assembled into an assembled implant, The graft implant is assembled into a single graft by use of a reinforcing material to hold the components of the graft material together and includes at least one mixed composition segment.   68. The graft implant of claim 67, wherein the reinforcing material comprises cortical bone.   68. The graft implant of claim 67, wherein the assembled implant is pretreated or processed after assembly to incorporate biologically active or inert material.   Crowd dowels, iliac crest wedges, or sponges with assembled cancellous blocks or dowels taken from the iliac crest or another suitable site and reinforced by inserting cortical bone pins inside 68. The implant of claim 67, forming a quality block, a dowel.   68. The implant of claim 67, comprising a cortical bone implant reinforced by inserting at least one cortical bone pin therein.   68. The implant of claim 67, comprising an assembled implant comprising different segments of cortical bone, cancellous, or both.   68. The implant of claim 67, which is in the form of a tapered dowel.   68. The implant of claim 67, comprising an assembled implant comprising different segments of cortical bone, cancellous, demineralized cortical bone or cancellous, or synthetic material, or combinations thereof.   72. The implant of claim 71, wherein insertion of the reinforcing pin provides a plurality of load bearing pillars to the implant.   76. The implant of claim 75, wherein the pin protrudes from a surface of the implant to engage the lower, upper, or both surfaces of the bone into which the implant is inserted.   68. The implant of claim 67, wherein the implant is a spinal implant.   68. comprising a spongy portion of a bone implant, said portion being fixed to cortical bone or other portions of cortical bone that are compression molded and then machined according to different or similar principles. The described implant. Bone graft, the following:
a. Two or more bone segments,
b. Comprising at least one biocompatible connector;
c. The at least one biocompatible connector secures the two or more bone segments together to form an assembled bone graft, wherein the at least one biocompatible connector does not include an adhesive; Transplant.   80. The bone graft of claim 79, wherein at least one of the two or more bone segments is a mixed composition segment.   An assembled bone graft comprising at least three segments, each of the segments comprising a first edge and a second edge opposite the first edge; The first and second edges have interlocking structures that are matable with adjacent edges of adjacent segments, whereby each of the first and second edges of the segment is adjacent to the segment Assembled bone graft that interlocks with the edges of the bone.   An assembled bone graft comprising at least three non-coplanar segments, each segment comprising a first matable edge and a second matable edge, the mating Each of the possible edges is matable with an adjacent matable edge of an adjacent segment, whereby the assembled bone graft is positioned adjacent to each other of the segments. An assembled bone graft assembled by mating one edge and the second edge.   84. The assembled bone graft of claim 82, wherein the matable edge is interlocked and selected from the group of joint types consisting of ball joints, tongue and groove, and mortise joints.   83. The assembled bone graft of claim 82, further comprising at least one band of flexible, non-stretchable material, the band being wrapped around the periphery of the assembled bone graft. Piece.   83. At least one of the segments is comprised of a material selected from the group consisting of demineralized bone, mineralized bone, a combination of demineralized and mineralized bone. The assembled bone graft as described.   84. The assembled bone graft of claim 82, wherein at least one of the segments is composed of a material selected from the group consisting of cortical bone, cancellous, and a combination of cortical and cancellous.   83. At least one of the segments is comprised of any one or combination of autograft material, allograft material, xenograft material, synthetic material, and metallic material assembled into a segment. The assembled bone graft as described.   An assembled bone graft comprising first and second arcuate segments, each segment comprising two interlocking edges, whereby each of the edges of the first segment is An assembled bone graft that interlocks with an edge of the second segment to form an assembled bone graft having an open channel between the first and second segments.   Bone-tendon-bone graft useful in orthopedic surgery comprising at least one block and a flexible band attached to the at least one block Piece.   At least one of the at least one block is made of a synthetic material and the flexible band is made of allograft or xenograft tendon, ligament, or compressed dermis. 90. A bone-tendon-bone graft according to item 89.   90. At least one of the at least one block is comprised of cortical bone, cancellous, dermis-sponge, or a combination thereof, and the flexible band is comprised of a synthetic material. Bone-tendon-bone graft.   The synthetic material is nylon, polycarbonate, polypropylene, polyacetal, polyethylene oxide and copolymers thereof, polyvinyl pyrrolidone, polyacrylate, polyester, polysulfone, polylactide, poly (L-lactide) (PLLA), poly (D, L-lactide) ( PLA), poly (glycolide) (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co-glycolide) (PLA / PGA), poly (glycolide) -Co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly (phosphazene), poly (D, L-lactide-co-caprolactone) ( PL / PCL), poly (glycolide-co-caprolactone) (PGA / PCL), poly (phosphatase ester), polyanhydride, polyvinyl alcohol, and a biocompatible material selected from the group consisting of hydrophilic polyurethane 92. The bone-tendon-bone graft of claim 91.   92. The bone-tendon-bone graft of claim 91, wherein at least one of the at least one block is composed of an assembled bone graft.   94. The bone-tendon-bone type graft of claim 92, wherein the assembled bone graft is comprised of at least one mixed composition segment. A method for assembling an assembled implant to obtain a desired interference fit, comprising:
a. Drying at least one bone pin under reduced pressure to obtain a desired reduction in size;
b. Measuring the diameter of the at least one bone pin after drying under reduced pressure;
c. Creating at least one hole in at least one bone fragment assembled with the at least one bone pin, wherein the hole is formed on the at least one bone pin to obtain an interference fit. Smaller than diameter, process;
d. Assembling the at least one bone pin with the at least one bone fragment by inserting each of the at least one pin into the at least one hole to form the assembled implant; and e. . Freeze-drying the assembled implant;
Wherein the interference fit between the at least one bone pin and the at least one hole in the at least one bone fragment falls within a desired range.   96. The method of claim 95, wherein the at least one bone pin is comprised of cortical bone and optionally, at least one of the at least one bone fragment is comprised of cortical bone.   99. The method of claim 96, wherein a desired range for the interference fit is 0.001 to 0.003 inches.   99. The method of claim 96, wherein the vacuum drying step is connected to a negative pressure of about 100 millitorr at room temperature and lasts at least 5 hours.   An assembled implant comprising at least two substantially flat segments, wherein at least one of the at least two substantially flat segments comprises at least one slot defined therein; and An assembled, wherein at least two substantially flat segments are secured together by sliding the at least one slot of at least one flat segment over another substantially flat segment Transplant.   The implant includes a first substantially flat segment and a second substantially flat segment, the first and second substantially flat segments being defined longitudinally thereon. The first and second substantially flat segments comprise slotted sections and body sections, and the first and second substantially flat segments respectively 100. The assembled implant of claim 99, wherein the slotted section of is secured by sliding the other body portion into the other. Bone-tendon implant, the following:
At least one assembled bone block comprised of mineralized bone, demineralized bone, or synthetic material, or a mixed composition; and attached to the at least one bone block At least one flexible band, wherein the band is composed of demineralized bone or synthetic material,
A bone-tendon implant comprising:

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