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    公开号:BR112012001637B1
    申请号:R112012001637-7
    申请日:2010-07-26
    公开日:2018-05-22
    发明作者:J. Melkent Anthony；R. Thoren Brian；J. N. Smith Timothy；D. Grant Ian；R. Dunkley Ian
    申请人:Warsaw Orthopedic, Inc.；
    IPC主号:
    专利说明:

    (54) Title: IMPLANTABLE MEDICAL DEVICE (51) Int.CI .: A61L 27/42; A61L 27/56; A61L 27/58 (30) Unionist Priority: 7/24/2009 US 12/508856 (73) Holder (s): WARSAWORTHOPEDIC, INC.
    (72) Inventor (s): ANTHONY J. MELKENT; BRIAN R. THOREN; TIMOTHY J. N. SMITH; IAN D. GRANT; IAN R. DUNKLEY “IMPLANTABLE MEDICAL DEVICE” FUNDAMENTALS
    The present invention relates to implantable medical devices and methods for making and using such devices and, more particularly, but not exclusively, relates to devices for promoting internal bone and / or tissue growth, supporting the process of natural bone remodeling through osteoblast and osteoclast activity and / or to stabilize and promote bone and / or tissue fusion between <adjacent bones or bone tissues.
    Various types of devices, implants and systems have been used to stabilize and promote bone and tissue fusion between adjacent bones or bone tissues in a patient. In one form, implants or devices formed by autograft (bone removed from the patient) or graft (bone taken from someone else) have been used due to their osteoinductive and / or osteoconductive properties. However, several difficulties were encountered with the use of autograft and graft. For example, autograft has a high incidence of local donor morbidity, the need for a second painful 'collection' surgical procedure, and the absence of large amounts of bone available for grafting, while allograft presents concerns related to disease transmission, the difficulty of acquisition and processing, the uncertain immune response and premature resorption. In addition, several considerations related to the anatomical space in which the implant or device is implanted, such as compression loads, for example, may present difficulties in the implementation of the autograft or allogeneic transplant and / or cause undesirable side effects if the self - graft or graft is used.
    Although developments in the stabilization and fusion of adjacent bones or bone tissues have moved in the right direction, there is still a need for further development in this area of technology.
    SUMMARY
    A non-limiting modality of this application is • directed to an implantable medical device. In one aspect of this modality, the device is configured to promote internal bone and / or tissue growth, supporting the process of natural bone remodeling through activity of osteoblasts and osteoclasts, or to stabilize and promote bone and / or tissues between adjacent bones or bone tissues, although devices configured to provide a combination of some or all of the above characteristics are disclosed.
    In another embodiment, an implantable medical device includes a body including an external surface defining an external profile of the device. The body also includes a porous matrix including a series of interconnected macropores defined by a plurality of interconnected structures, including a hollow interior. A filler material substantially fills at least a portion of the series of interconnected macropores. A plurality of openings extends over at least a portion of the outer surface and communicates with the hollow interior of at least a portion of the plurality of interconnected structures. In another aspect of this modality, the external surface is defined by a plurality of openings, exposed areas of the porous matrix and exposed areas of the filling material. In another aspect of this embodiment, the porous matrix is formed from a ceramic material and the filler material is a polymeric material. In yet another aspect, the ceramic material is resorbable and the polymeric material is biologically stable. In yet another aspect, the filling material is infused whole and substantially fills each of the series of interconnected macropores.
    In yet another embodiment, a method includes providing an implantable medical device that includes a body, including an external surface defining an external profile of the device. The body also includes a porous matrix including a series of interconnected macropores defined by a plurality of interconnected structures, • including a hollow interior, a filling material substantially filling at least a portion of the series of interconnected macropores, and a plurality of openings extending. through at least a portion of the outer surface and communication with the hollow interior of at least a portion of the plurality of interconnected structures. The method also includes positioning the device between adjacent bone portions. In another aspect of this embodiment, the positioning device between adjacent bone portions includes inserting the device into a space in the disc between adjacent vertebral bodies.
    In yet another embodiment, an implantable medical device includes a body including an outer surface defining an end profile of the device. The body also includes a resorbable ceramic matrix, including a series of interconnected macropores defined by a plurality of interconnected structures that further defines a plurality of interconnected passages isolated from the series of interconnected macropores. A biologically stable polymeric material is infused whole and substantially fills the series of interconnected macropores, while the plurality of interconnected passages are substantially free of the polymeric material. In one aspect of this embodiment, at least a portion of the plurality of interconnected passages and extends through the open on the outer surface of the body. In another aspect of this modality, the body is configured to be positioned between adjacent bones or bone tissue, and the outer surface includes opposite bone positioned to wrap portions each including a plurality of surrounding bone projections structured to engage with the bones adjacent tissues or bone tissue.
    In another embodiment, a method for producing a medical implant includes providing a resorbable ceramic matrix, including a series of interconnected macropores defined by a »
    plurality of interconnected structures, to interconnected structures including a • plurality of internal interconnected passageways positioned therein; impregnating the ceramic matrix with a biologically stable polymeric material to provide a white compound; and processing the blank composites to provide an implant body including an outer surface defining an outer profile of a desired configuration and form of implantation, including processing exposing at least a portion of the internal interconnected passages on the outer surface. In another aspect of this modality, the outer surface also includes one or more exposed areas of the polymeric material and one or more exposed areas of the ceramic matrix.
    In yet another embodiment, an implantable medical device includes a body having an external surface defining an external profile of the device. The outer surface includes one or more exposed areas of a matrix that includes one or more openings and a biologically stable filler material substantially filling at least a portion of one or more openings. After implantation, the matrix undergoes a remodeling process in which the activity of osteoclasts progressively removes portions of the matrix and the activity of osteoblasts progressively replaces the portions removed from the matrix with new bone tissue. Beginning of the remodeling process is generally limited to one or more exposed areas of the matrix. In one aspect of this modality, the beginning of the remodeling process is limited to the areas of the matrix that are exposed in, or before, the implantation of the device. In another aspect of this modality, the remodeling process progressively replaces the beginning of the matrix on the external surface and progressively moving inwardly into the device until all or substantially all of the matrix has been replaced by new bone tissue. In another aspect, the matrix is formed by Skelite® and the biologically stable filling material is selected from polyetheretherketone (PEEK), PEEK reinforced carbon, and polyetherketone acetone (PEKK).
    Another embodiment of the present application is directed to a single device for stabilizing adjacent bones or bone tissues. Other modalities include unique methods, systems, devices, equipment and / or devices aimed at promoting bone and / or internal tissue growth, promoting the natural process of bone remodeling through the activity structure of osteoblasts and osteoclasts, and / or the stabilization and fusion of adjacent bones or bone tissues. In yet other embodiments, different forms and applications of the present invention are envisaged.
    Additional modalities, shapes, characteristics, aspects, benefits, advantages and objects of the present invention must be evident from the detailed description and figures presented in the annex.
    BRIEF DESCRIPTION OF THE FIGURES
    FIG. 1 shows a photographic image of an implantable medical device modality.
    FIG. 2 shows a photographic image of a porous matrix included in the implantable medical device of FIG. 1.
    FIGS. 3 and 4 show enlarged photographic images of the porous matrix illustrated in FIG. 2.
    FIG. 5 shows an enlarged photographic image representative of the external surface of the implantable medical device of FIG. 1.
    DESCRIPTION OF THE ILLUSTRATED MODALITIES
    For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the modalities illustrated in the drawings and specific language will be used to describe them. However, it will be understood that no limitation on the scope of the invention is intended. Any changes, such and other modifications to the illustrated devices and methods described, and any other applications as of the principles of the invention, as illustrated here are contemplated as would normally occur for one skilled in the art to which the invention relates.
    Implantable medical devices, implants and methods for making and using such devices and implants are provided. More particularly, in one embodiment, a device is provided that promotes internal bone and / or tissue growth, promotes the natural bone remodeling process through the structure of osteoblast and osteoclast activity, stabilizes adjacent bones or bone tissues and / or promotes bone or tissue fusion between adjacent bones or bone tissues, although devices configured to provide a combination of some or all of the above characteristics are disclosed. In a particular aspect of this modality, the device includes mechanical properties that mimic bones and are suitable for supporting compression loads at a selected anatomical site, such as a location between adjacent bones or bone tissue. Generally, the device of this modality includes a porous matrix formed of an osteoconductive and / or osteoinductive material, such as a calcium-based ceramic that can be resorbable over time after implantation. In a specific way, the matrix is formed of a ceramic material that undergoes a remodeling process having aspects that are substantially similar to certain aspects of the natural bone remodeling process. More particularly, in this way the ceramic material is progressively removed by the activity of osteoclasts, with the removed portion of the ceramic material being progressively replaced by new bone formed through the activity of osteoblasts. Further details on this feature will be provided below. The porous matrix also includes a series of interconnected macropores defined by a plurality of interconnected structures, with each structure including a hollow interior, more details than will be provided below. At least a portion of the interconnected series of macropores is substantially filled with a filler material, although in other forms each of the interconnected series of macropores is infused with and substantially filled by the filler material, while the hollow interiors of the interconnected structures remain substantially open or free of the filling material. In one form, the filler material can be biologically stable, like a biologically stable polymeric material. As used here, the term "biologically stable" is used to refer to materials that remain substantially intact or non-reabsorbed, and after implantation in a biological environment. However, in another form, it is contemplated that the filler material can be resorbable and if it becomes resorbed, at the same time as the porous matrix is resorbed or after the porous matrix has become resorbed. In one form, the device also includes an outer surface having a plurality of openings extending through it and communicating with the hollow interior (s) of at least a portion of the plurality of structures.
    In this way, all or part of the external surface of the device is organized to include one or more exposed areas of the porous matrix formed by the osteoconductor and / or osteoinductive material and one or more exposed areas of the filling material, in addition to the exposed openings in communication with the hollow interior of at least a portion of the stirrup. Among other features, this arrangement provides an external surface that can promote bone attachment and bonding to the exposed area (s) of the porous matrix, as well as bone and / or tissue growth and penetration into the device through the openings of communication with the inner cavity of at least a portion of the interconnected structures. These features can, inter alia, facilitate enhanced device blockage between adjacent bones or bone tissue, promote fusion between adjacent bones or bone tissues and / or decrease the time required to achieve fusion between adjacent bones or bone tissues. In addition, the openings in communication with the hollow interior of at least a portion of the interconnected structures generally allow infusion of tissue into the device more quickly, providing anchoring of the device at the beginning of the healing period after implantation. In another aspect where the osteoconductive and / or osteoinductive material is more resorbable after the implantation of time, the progressive integration of the device due to the nature of the porous resorbable matrix increases the level of anchoring and blocking of the device that is performed by the first bone infusions and / or fabrics for the hollow interior of the structures.
    In addition, in the form in which the porous matrix is formed of a ceramic material that undergoes a remodeling process having aspects that are substantially similar to certain aspects of the natural bone remodeling process, the device includes surface chemistry that promotes the activity of osteoclasts, which allows bone connection and formation in the exposed area (s) of the porous matrix and along the interior surfaces of the hollow interiors of the structures. More particularly, the activity of osteoclasts can progressively remove portions of the porous matrix exposed on the outer surface of the device, as well as along the inner surfaces of the hollow structures. Osteoblast activity then correspondingly and progressively replaces the portions removed from the porous matrix with new bone tissue. Likewise, the hollow interior of the interconnected structures provide additional exposure material in which osteoclasts and the corresponding osteoblast activity can occur progressively by replacing the porous matrix material with new bone tissue. Likewise, the blockage of the device between adjacent bones or bone tissues is enhanced and an internal tissue growth in the hollow interior expands as the porous matrix material is remodeled.
    In addition to the above, it should be appreciated that the filler material provides a stable surface on which adjacent bones or bone tissues can be supported. The filling material also provides the device with high fracture toughness and a bone-like modulus of elasticity, reinforcing the porous matrix so that the device can withstand loads and stresses commonly found in various locations in the skeleton. In addition, when the osteoconductive and / or osteoinductive material is resorbable over time after implantation and the filler material is biologically stable, it can continue to provide support to adjacent bones or bone tissue after resorption of the porous matrix. In fact, in this form, the biologically stable filler material generally becomes a porous matrix into and through which bone and / or tissue infuse contemporaneously with or after resorption of the porous matrix. Further details on these and other details of the devices disclosed and described in this document will be provided below.
    In an alternative embodiment, a device is provided that includes a body formed by a ceramic matrix that includes one or more openings and a biologically stable filling material that substantially fills at least a portion of the spaces, although in one or more forms it is contemplated that the biologically stable filling material can be infused throughout and substantially fill all openings. In such a way, the openings are defined by a series of interconnected macropores. In another form, however, the openings are defined by channels or passages that extend inward or partially through the body. Still, otherwise the ceramic body includes a geometry designed or structured in the form of a frame that defines the openings. In such a way, the device includes an external surface that defines an external profile of the device and includes one or more exposed areas of the ceramic matrix and filling material, although it should be appreciated that the entire external surface could be defined by exposed areas of the ceramic matrix and filling material. The ceramic matrix is formed from a ceramic material that undergoes a remodeling process having aspects that are substantially similar to certain aspects of the natural bone remodeling process. More particularly, in this way the ceramic material is progressively removed by the activity of osteoclasts, with the portions removed from the ceramic material being progressively replaced by new bone formed through the activity of osteoblasts. Likewise, after implantation of the ceramic matrix device, it undergoes a remodeling process in which the activity of osteoclasts progressively removes portions of the ceramic matrix and osteoblast activity progressively replaces the portions removed from the ceramic matrix with new bone tissue. In one aspect of this modality, the beginning of the remodeling process is limited to the areas of the ceramic matrix that are exposed on the external surface of the device. More particularly, it should be appreciated that the ceramic matrix will be reshaped into new bone tissue by a process that begins on the external surface of the device continuously and progressively over time towards or into the device. Likewise, since the filling material in this modality is biologically stable, the progress of the remodeling process towards or into the device can only originate in or from the exposed areas of the ceramic matrix on the external surface of the device. In another more specific aspect, the beginning of the remodeling process can be limited to areas of ceramic matrix that are exposed on the external surface of the device with or before implantation.
    Although not discussed previously, the ceramic matrix of this modality also includes a plurality of interconnected structures that define the openings. In contrast to the modality described above, in this modality, it is contemplated that each of the structures can be provided with a solid transversal or filled section, although the forms in which each of the structures is provided with hollow interiors are also contemplated. Likewise, depending on the shape of the ceramic matrix, the prediction is that in one or more shapes of the external surface of the device of this modality it can be provided with openings extending through it and communicating with the hollow interior (s) of at least one portion of the plurality of structures.
    Similar to the modality discussed above, the device of this modality can promote internal bone and / or tissue growth, promote the natural bone remodeling process through the structure of osteoclast and osteoblast activity, stabilize adjacent bones or bone tissues and / or promote fusion bone and / or tissue between adjacent bones or bone tissues. In a particular aspect of this modality, the device includes mechanical properties that mimic bones and are suitable for supporting compression loads at a selected anatomical site, such as a location between adjacent bones or bone tissue. In addition, the external surface of the device of this modality includes the surface chemistry that allows the connection of bone formation and to start in the exposed area (s) of the ceramic matrix and progressively continue from the direction or exposed areas in the internal portions of the device. Likewise, the blocking of the device between adjacent bones or bone tissues is enhanced and an internal growth in the tissue device expands the ceramic matrix is remodeled.
    In addition, the biologically stable material in this way provides a stable surface on which adjacent bones or bone tissues can be supported. The filler also provides the device with high fracture toughness and a bone-like modulus of elasticity, reinforcing the ceramic matrix so that the device can withstand loads and stresses commonly encountered at various locations in the skeleton. In addition, as the ceramic matrix is progressively remodeled and replaced with new bone, the filler material can continue to support adjacent bones or bone tissues. Further details on these and other details of the devices disclosed and described in this document will be provided below.
    The prediction is that the devices described above can be used anywhere on the skeleton in any of a wide variety of applications where bone or tissue for repair or growth is needed or desired. More particularly still not limiting, the device can be configured for positioning between adjacent bones or bone tissues to provide structure along a load axis of bones or bone tissues, although non-load applications are also contemplated. For example, referring now to FIG. 1, a photographic image shows a final view of an arthrodesis implant device 10 structured to facilitate fusion between adjacent vertebral bodies. Device 10 generally includes a "D-shaped" body 12 structured for positioning in the disc space between adjacent vertebral bodies. The body 12 also has an outer surface 14 extending around the outer profile and following the shape of the device 10. Device 10 also includes a side wall 16 that extends around and surrounds a hollow chamber 22 in which bone growth, such as bone fragments, bone morphogenetic protein, LIM mineralization proteins (LMPS) and other growth factors, can be placed. External surface 14 includes oppositely positioned upper and lower portions 18, 20 that are formed with projections 24 structured to engage with adjacent vertebral bodies and resist the expulsion of the device 10 from the disk space. In one or more shapes, upper and lower portions 18, 20 can be angled relative to each other to provide a configuration that corresponds to the lordotic angle between adjacent vertebral bodies, between which device 10 will be positioned. In addition, while not illustrated, it should be appreciated that device 10 may be provided with one or more instrument fitting portions to facilitate participation and placement of the device in the disk space with a suitable instrument. It is also contemplated that device 10 could be provided with alternative external configurations, the non-limiting examples of which are disclosed in US Patent Nos. 7,192,446, 6,595,995, 6,613,091, 6,645,206, 6,695,851, 6,174,311, 6,610 .065, 6,610,089, 6,096,038, 6,746,484, 6,471,724, 6,764,491, 6,830,570, 6,447,547, 6,991,654, 5,797,909, 5,669,909, 5,782,919, 5,984,967 , 6,206,922, 6,245,072, and 6,375,655 and in US Patent Publication No. 2008/0161927.
    As also illustrated in FIG. 1, device 10 includes a matrix 26 and a filling material 40 which has been infused into and in all openings of the matrix 26. More particularly, in the illustrated form, filling material 40 is infused into and in all the openings defined by macropores of the matrix 26. In another form, however, the matrix openings 26 can be defined by channels or passages that extend inward or partially through the matrix. In yet another form of matrix 26 it includes a geometry projected or structured in the form of a frame that defines the openings. In other forms not shown, however, the filler material 40 substantially fills only a portion of the die openings 26. In the illustrated form, body 12 includes exposed portions of the die 26 and filler material 40 and along its entire profile outer and outer surface 14. More particularly, the outer surface 14, including the portions dispersed throughout the outer profile and following the shape of the device 10 (including hollow inner 22), includes the exposed areas of the matrix 26 and filler 40. In addition, although not illustrated in FIG. 1, body 12 also includes a plurality of openings positioned around and along its outer profile and the outer surface 14, more details of which will be provided below in relation to FIG. 5. The openings are generally positioned within the exposed areas of the matrix 26 and communicate with hollow interiors of matrix structures 26. Still, in other forms the structures of matrix 26 can be provided without hollow interiors and include a section solid or full transverse. Likewise, in this form of external surface 14 it does not include the openings extending through it. In other forms, however, it is contemplated that the matrix structures 26 could be hollow, while the outer surface 14 does not include the openings extending through them, or that the outer surface 14 could only be provided with openings in one or more desired regions. In other non-illustrated forms, it is contemplated that only a portion or distinct portions of outer surface 14 can be supplied with the exposed areas of the matrix 26 and filler 40. For example, in such a way, 14 outer surface can only be supplied with the exposed areas of the filling material matrix 26 and 40 along the upper and lower portion 18, 20. In another example, the outer surface 14 can only be provided with the exposed areas of the matrix 26 and filling material 40 along the wall portion lateral positioned next to 16 chamber 22. Still, as would be appreciated by those skilled in the art, alternative configurations for the positioning of the exposed areas of the matrix 26 and filling material 40 along the external surface 14 are contemplated.
    In FIG. 2 there is a photographic image of the matrix 26 which provides a scaffold in which filling material 40 can be infused, although filling material 40 is absent from matrix 26 in FIG. 2. Matrix 26 includes a plurality of structures 28 that define a series of interconnected voids or macropores 30. Only a portion of structures 28 and macropores 30 have been marked in FIG. 2 to preserve clarity. In the form illustrated in FIG. 2, matrix 26 generally has a hollow cylindrical shape, although it is contemplated that other configurations of matrix 26 can be used for device 10. Structures 28 of each matrix 26 include a hollow interior or passageway 34 that can be seen in the enlarged photographic images of the matrix 26 in FIGS. 3 and 4. The passages 34 of the structures 28 are interconnected in fluid communication with each other, forming a cavity of passages 34 in the matrix, which extends through structures 28. Likewise, passages 34 are generally isolated from the series of macropores 30 by side walls of structures 28, although it is contemplated that some communication between passages 34 and macropores 30 can occur through micropores 32 (FIG. 4) in structures 28. A portion of passages 34 is exposed in Figs. 3 and 4 for illustrative purposes and clarity, although it should be appreciated that passages 34 will generally not be exposed upon initial fabrication of the matrix 26 because the ends of the structures 28 are generally closed, as will be appreciated in view of the process described below for make matrix 26. Before, in the subsequent treatment, a portion of the material at the end of the structures 28 can be removed to expose passages 34. In this way, one or more portions of matrix 26 can be impregnated with filler 40 without the passages 34 are filled with filler material 40. Likewise, when one or more portions of matrix 26 are impregnated with filler material 40, the passages 34 remain substantially free of filler material 40, except for any unintended leakage that may occur through microporous 32, one end of a frame 28 that is not completely closed, or any other surface cracks unintentional or defects. In the case of device 10, in one form the passages 34 can be exposed to the next infiltration of one or more portions of matrix 26 with filler material 40 and while molding device 10 in its final configuration, more details of which are presented in follow.
    In other forms, matrix 26 may be provided with structures 28 that do not include the hollow interior. In contrast, in these forms, structures 28 are formed of material of which matrix 26 is formed and include substantially solid cross-sectional configurations. Likewise, when one or more portions of matrix 26 are infiltrated and filled with filler material 40, which generally does not enter or fill any portion of structures 28. In addition, as suggested above, matrix 26 can also be formed to include one or more channels or passages that extend or partially extend throughout the body and define matrix 26 openings instead of macropores 30. In addition, in another form of matrix 26 it includes a projected and structured geometry in the form of a frame that defines matrix openings 26.
    Matrix 26 can be formed from a sintered or non-sintered ceramic composite material, which is synthetic, natural, resorbable or non-resorbable. In one aspect of this form, the ceramic material, which is radiopaque, provides device 10 with desirable image properties, even after one or more portions of matrix 26 are filled with filling material 40. In particular, matrix 26 is formed from a sintered ceramic material that is osteoconductive and / or osteoinductive and is resorbable or biodegradable in vivo. Declared as an alternative, the ceramic material is a bioactive material insofar as they can provoke a biological response on its surface which results in the formation of a bond with the adjacent tissue. Non-limiting examples of the ceramic material include calcium-based ceramics, such as calcium sulfate, calcium carbonate or a calcium phosphate material, such as hydroxyapatite, carbonated apatite, fluroapatite, a tricalcium phosphate, such as tricalcium α-phosphate or β-tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate and mixtures thereof. In particular, matrix 26 can be formed from a bioabsorbable or biodegradable ceramic material, which undergoes a remodeling process having aspects that are substantially similar to certain aspects of the natural bone remodeling process. Thus, in contrast to other ceramic materials that have no specific dissolution that undermines the structural performance of the initial bone fixation, the ceramic material in this way uses remodeling based on host cells to provide an evolved, yet stable interface that maintains local structural performance throughout the bone replacement process. For example, in this way the ceramic material is progressively removed by the activity of osteoclasts, where the microarchitecture of the portions removed from the ceramic material is progressively and sympathetically replaced by new bone formed through the activity of osteoblasts. More particularly, the matrix surfaces facilitate an interfacial binding of bone cell activity, which creates an extracellular matrix that becomes solid through subsequent mineralization. A particular form of ceramic material that undergoes a remodeling process having aspects that are substantially similar to certain aspects of the natural bone remodeling process is Skelite®, which is an isolated resorbable biomaterial commercially available from Medtronic, Inc., 710 Medtronic Parkway , Minneapolis, MN 55432-5604 USA. More specifically, Skelite® is a compound that includes oxygen, calcium and phosphorus, in which a portion of at least one of these elements is replaced by an element having an ionic radius of about 0.1 to 0.6 Å. Non-limiting examples of these elements include Silicon and Boron, although the use of other elements that satisfy the preceding criteria is contemplated. Specifically, this compound has the biomaterial formula:
    (Ca) j {(P i _ x .y. Z B x C y D z ) Oj} 2
    Where B, C and D are selected from those elements having an ionic radius of approximately 0.1 to 0.4 Â;
    x is greater than or equal to zero, but less than 1; y is greater than or equal to zero, but less than 1; z is greater than or equal to zero, but less than 1; x + y + z is greater than zero, but less than 1; i is greater than or equal to 2, but less than or equal to 4; and j is equal to 4-δ, where δ is greater than or equal to zero, but is less than or equal to 1.
    More details on this compound can be found in U.S. Patent No. 6,323,146, the contents of which are hereby incorporated by reference in their entirety.
    For the illustrated form of matrix 26, it can be formed from a cross-linked organic foam structure having a plurality of interconnected voids. More particularly, in a way, a polyurethane foam is heated quickly to rupture and removes the thin walls between the gas bubbles in the foam webs to provide a sponge, where the pores are interconnected rather than closed. Porous foam structures having this configuration are commercially available or can be prepared, if desired, and facilitate the formation of passages 34 of structures 28. For those forms in which structures 28 are not hollow, matrix 26 can be formed using a pore agent that form like polymeric spheres that are in contact at the time of the matrix infusion with the ceramic material and then removed during the sintering of the matrix. The foam structure is impregnated with an aqueous suspension of the ceramic material in such a way that the ligaments or foam structures are coated and the voids are substantially filled. The excess paste is removed from the pores and the coated structure is dried to form what is normally called a green body (ie a non-sintered coated foam structure). Drying can take anywhere from a few minutes to more than an hour as would be appreciated by those of skill in the art. This process is repeated until the slurry coating reaches the desired thickness throughout the foam structure. Typical coating thickness can be about 10 to about 100 microns. The coated structure is then heated by first burning the flexible organic foam and then sintering, thus providing a molten ceramic foam having a plurality of interconnected voids in the form of macropores 30. Heating is typically done at temperatures of around 25 ° C to about 500 ° C. Sintering is normally carried out at temperatures from about 900 ° C to about 1500 ° C. The heating and sintering can be done in succession such that the temperature is increased to the sintering temperatures of the heating temperatures.
    Preparation of the ceramic material suspension involves combining the ceramic material with a fluid medium, usually water, and a dispersing agent. Dispersing agents can be used to prevent agglomeration of ceramic particles and can be organic or inorganic. Examples of organic dispersants include sodium polyacrylate, ammonium polyacrylate, sodium citrate, sodium tartrate and mixtures thereof. Examples of inorganic dispersants include sodium carbonate, sodium silicate, tetrasodium pyrophosphate and mixtures thereof. The amount of dispersant added is typically but not limited to between about 1 and 3.5 volume percent.
    It has been found that the initial particle size of the ceramic material can influence the strength of the final matrix 26. In addition, the particle size can also influence both the solid charge capacity and the resulting viscosity of the solution. Milling a portion of the slurry proved to be useful in obtaining the desired particle size distribution.
    Typically, a portion of the suspension can be ground between 1 and 24 hours using an inert material, grinding-resistant abrasive media such as alumina or zirconia to provide ceramic particles of up to 50 microns (and of any size or size ranges) up to about 50 microns). In order for the ceramic particles of the slurry to adhere to both the foam substrate and to each other, it is desirable that, after the particle size reduction, the slurry is thixotropic in nature. That is, the viscosity of the suspension is reduced by increasing shear rates.
    Additives can also be added to the ceramic material suspension before being impregnated into the cross-linked foam body. Non-limiting examples of these additives include a binder to give strength to the green body, a wetting agent to improve the distribution of the slurry throughout the foam, and an anti-foaming agent that reduces the formation of bubbles in the slurry. These components are normally added to the paste in small amounts, including but not limited to less than about 10 volume percent for the binder and less than about 2 volume percent for wetting and defoaming agents.
    Matrix 26 can be supplied with a compressive strength of about 10 MPa, applying several layers of the ceramic material suspension and drying the impregnated structure between each coating. While the porous foam structure may start to become clogged as the coatings are applied last, it has been found that using a paste with a high content of filler solids (up to about 30 percent by volume) for the first coats several, followed by several coats with a paste that has the lowest load of solids (below about 20 percent by volume) helps to prevent any clogging.
    In one form, a vacuum process can be used to remove excess slurry from the foam body. In this case, the impregnated foam is placed on a mesh screen mounted on top of a vertically mounted vacuum hose and the excess slurry is extracted through the hose inside the vacuum unit. Alternatively, a controlled gas jet can be used to disperse the excess slurry that clogs the internal pores.
    To remove the foam structure, the dried, coated structure can be transferred to an electric oven and heated to and maintained at a sufficiently high temperature (ie up to about 200 ° C) to remove water initially and then at higher temperatures (for example, up to about 500 ° C) to pyrolyze the base polymer foam. Subsequent sintering of the ceramic structure (at temperatures up to about 1500 ° C, more preferably about 1200 ° C to about 1500 ° C) is carried out by heating to a temperature significantly higher than the temperature used to pyrolyze the foam. The stove is then allowed to cool to room temperature.
    Although not previously described, it should be appreciated that one or more properties of the foam structure can be modified to provide matrix 26 with structural characteristics that are desirable for one or more device forms 10. For example, in one way, the structure Foam can be supplied with different void fractions that can be used to provide matrix 26, in a form that will ultimately result in a material filling ratio matrix that is subject to certain strength and modulus characteristics. In one aspect of this form, for example, it is contemplated that the dimensions of the macropores of the foam structure can be modified correspondingly that modify the positioning of the structures 28 of the matrix 26. In another way, it is contemplated that the foam structure can be supplied with an anisotropy configuration that will end up giving matrix 26 anisotropic properties. Likewise, device 10 could be formed with matrix 26 with anisotropic properties like that device 10 is provided with anisotropic properties that provide desired mechanical performance in one or more selected directions, similar to natural bone. In one aspect of this form, anisotropic properties can be achieved with a foam structure that includes a porosity gradient or elongated macropores. For example, the foam structure can be heated, stretched or compressed to elongate the macropores, and then cooled with the macropores retained in their elongated configuration. In another example, a porosity gradient can be obtained by fusing two or more foam structures than macropores of different sizes, although other alternative approaches are also contemplated.
    It is also contemplated that the foam structure can be modified so that it results in one or more regions of the device 10 being formed by a single material which is surrounded by matrix 26 and filler material 40. For example, portions of the foam structure can be removed from one or more regions and then these regions can later be supplied with ceramic material, filler material 40 or other alternative material. In particular, a region formed by a single material can be used in an area where the device 10 is surrounded by a placement device during the implantation of device 10, although other uses of one or more regions formed by a single material are contemplated. In addition to the above, it is also contemplated that the foam structure can be formed by a three-dimensional printing process to include an organized or non-random arrangement of ligaments or structures. In this form, the foam structure can be provided in an open ligament based cellular network, where the ligaments can be arranged to provide a configuration that will give desired mechanical properties to matrix 26 and, finally, device 10.
    In preparing the illustrated form of device 10, filling material 40 is infused into and throughout the series of macropores 30 once matrix 26 has been prepared. However, as indicated above, in alternative filler material 40 it is only infused into and used to fill a portion of the 30 macropores of the matrix 26. In this configuration, one or more portions of device 10 can be provided with exposed areas of the matrix 26 which are free of filler material 40, thus providing greater exposure of the matrix 26 and an open mesh for the tissue to grow. Filler material 40 generally reinforces the matrix 26 so device 10 can withstand loads and stresses commonly found at various locations in the skeleton and have mechanical properties that more closely mimic natural bone than what is achieved through matrix 26 alone. For example, filling device 40 can provide 10 with high fracture toughness and a bone-like modulus of elasticity. In one form, filler material 40 is a biologically stable polymeric material, although other types of biologically stable materials are contemplated, non-limiting examples of biologically stable polymeric materials include polyethylene, polymethylmethacrylate, polyurethane, polysulfone, polyetherimide, polyimide, molecular weight polyethylene ultrahigh (UHMWPE), crosslinked UHMWPE and members of the polyarylethylketone (Paek) family, including polyetherethylketone (PEEK), PEEK with reinforced carbon, and polyethercetonacetone (PEKK). In another form, it is contemplated that the filler material 40 may be a biodegradable bioabsorbable or polymeric material, although other types of bioresorbable or biodegradable materials are contemplated. In one aspect of this form, filler material 40 may be provided in a form that includes an in vivo degradation rate that is the same or slower than the degradation rate of matrix 26 when it is formed from a bioabsorbable material or biodegradable. Non-limiting examples of resorbable or biodegradable polymeric materials include poly (L-lactic acid), poly (D, L-lactic acid), poly (L-co-D, L-lactic acid), polyglycolide, poly (lactic-co-acid) -glycolic), poly (hydroxylbutyrate), poly (hydroxyvalerate), polycarbonate derived from tyrosine, polyanhydride, polyiorester, polyphosphazene, poly (dioxanone), poly (ε-caprolactone), and polyglycolate.
    In one or more forms, filler material 40 can be supplied as a composite material formed of, for example, a polymeric material and one or more osteoinductive and / or osteoconductive materials. For example, in particular, filler material 40 may be formed by a mixture of polymeric material and particles of the ceramic material from which matrix 26 is formed, although alternative forms of ceramic or osteoinductive and / or osteoconductive materials are contemplated. could be used. In this arrangement, filling material 40 can be provided with additional exposed areas of osteoinductive and / or osteoconductive materials, in order to promote additional bone union and / or increase the bioavailability of the eluted mineral elements from device 10. In addition, in one or more further forms it is also contemplated that cells in contact with particles of osteoinductive and / or osteoconductive materials in the filler material 40 can be stimulated to help initiate the bone repair process.
    It is anticipated that the filling material 40 can be impregnated in and fill all or portion of the macropores 30 of matrix 26 in all suitable forms. In a particular form however, macropores 30 can be filled with filler 40 by an injection molding process. For example, the die 26 can be positioned inside a mold of suitable size so that the filling material 40 can be injected under pressure. In one aspect of this form, the mold can be provided with an inner chamber that is larger than matrix 26 such that it becomes matrix 26 wrapped in filler material 40. As discussed above, in the illustrated form of matrix 26, where structures 28 are hollow, the passages 34 of structures 28 remain substantially free of filler material 40 after injection molding, from the passages 34 it is closed in the end portions of the corresponding structure 28 and generally isolated from the series of interconnected macropores 30. Furthermore, in the manner discussed above, where one or more portions of device 10 can be provided with exposed areas of the matrix 26 that are free of filler material 40, it is contemplated that the corresponding areas of the matrix 26 can be filled with a removable material, such as polyethylene glycol, waxes, hydrogels, or acrylic latex, before filling material 40 is added to the remaining portion (s) of matrix 26. Likewise, since material filler 40 has been added to the desired areas of the matrix 26, the removable material can be removed by dissolving with one or more solvents and / or thermal treatment, just to provide some possibilities. Furthermore, while not previously described, it should be appreciated that one or both of the matrix 26 and filler material 40 can be treated to promote or improve the interfacial chemical bond between them. For example, in one way, it is contemplated that one or more polar functional groups, such as ether or an ester, can be added to the filling material 40. In another way, it is contemplated that the matrix 26 can first be washed with ammonium hydroxide or some other solution that can alter the polarity on their surfaces. In yet another form, it is contemplated that a surfactant or an emulsifying agent can be added to filler material 40. For example, in one aspect of this form, it is contemplated that oleic acid could be added to filler material 40 before being infused in one or more portions of the matrix 26.
    Following the injection molding process, matrix 26 and filler 40 provide a white compound that substantially matches the size and shape of the mold used during the injection molding process and can be processed to provide device 10 in a desired configuration . For example, it is contemplated that the white compound can be processed in the desired configuration of the device 10 by any one or more means such as machining, cutting, laser modeling, chemical degradation, engraving, grinding, and hammering, just to give a few non- limiting.
    As the white is processed in the final configuration of the device 10, 26 matrix areas are exposed on the outer surface 14, in addition to areas of filler material 40. In the illustrated form, where structures 28 of the matrix 26 include the passages 34, the terminal portions and / or additional portions of at least a portion of 28 structures are removed during this processing, thus providing openings 36 exposing the corresponding passages 34, as illustrated in the photographic image of FIG. 5, which provides an enlarged view of a representative example of a portion of the outer surface 14 of the device 10. More particularly, structure 28 has been exposed to provide an exposed area of the matrix 26 surrounding opening 36 such that it is generally isolated from the material filler 40. Thus, opening 36 provides an access point for bone and / or tissue to grow in passage 34 of the corresponding structure 28. Furthermore, as each of the passages 34 is interconnected, it must be appreciated that the growth bone and / or tissue in one passage 34 can spread in additional passages 34, even if such additional passages 34 are not exposed through an opening 36 in the outer surface 14. It should still be appreciated that, depending on the amount of material removed from From a terminal portion of a frame 28, the exposed areas of the matrix 26 may be, as long as they do not include any opening 36 that exposes the corresponding passageway 34. In addition, openings 36, and to some extent, the exposed areas of the matrix 26, in general can be limited to areas of device 10 that are subject to further processing after the injection molding process to achieve the desired configuration of device 10 to from the blank compound formed by matrix 26 and filling material 40. Likewise, it is contemplated that, in one form, the outer surface 14 of the device 10 could include numerous openings 36 and / or exposed areas of the matrix 26, while in another form the outer surface 14 may only include a few openings 36 and / or exposed areas of the matrix 26 depends on the extent of post-used injection molding processing. Still, in other forms where structures 28 are not hollow and do not include passages 34, openings 36 will be absent from the outer surface 14. Furthermore, it is also contemplated that the white areas, which are processed after the injection molding process it can be at least partially, determined or influenced by considerations given to the anatomical location in which the device 10 will be implanted.
    In one or more forms, it is also contemplated that device 10 could be used to supply a pharmacological agent. For example, in a form where matrix 26 is formed of a bioabsorbable material, the pharmacological agent can be supplied on the outer surface of matrix 26 before macropores 30 are filled with filler 40. In this form, the pharmacological agent could be taken gradually exposed in vivo as matrix 26 is reabsorbed. In another form, however, it is contemplated that the pharmacological agent may be provided in passages 34, although other variations to provide the pharmacological agent are envisaged. For example, in an alternative form, it is contemplated that a pharmaceutical agent can be mixed in filler material 40 before being infused into at least a portion of macropores 30 from matrix 26 and then delivered in vivo from filler material. filling 40 after implantation of device 10. In one aspect of this form, filler material 40 can be supplied as a biodegradable or resorbable material, as a biodegradable material or bioresorbable polymer, and the therapeutic agent can be progressively released from filler material 40 as it degrades or is reabsorbed.
    As another alternative form, it is contemplated that a pharmaceutical agent could be provided in the exposed areas of the filler 40 after having been infused into at least a portion of macropores 30 of the matrix 26, and then delivered to the next live implant of the device 10 of the exposed surfaces of filler material 40. In one aspect of this form, a pore forming agent can be used on filler material 40 as it is infused into at least a portion of matrix 26 macropores in order to provide one or more pores in the filler 40 where the pharmaceutical agent can be deposited. In other respects, it should be appreciated that the exposed areas of filler material 40 may undergo chemical or mechanical processing before the pharmaceutical agent is provided therein to improve bonding or adhesion between the pharmaceutical agent and filler material 40. Additionally or alternatively, the pharmaceutical agent can be subjected to chemical processing to improve the adhesion or bonding between it and filler material 40. Still, in other aspects of this way it is contemplated that one or more types of bioresorbable adhesives can be used to attach the pharmaceutical agent to the exposed areas of filling material 40.
    When included, the pharmacological agent may include a growth factor that may increase the rate of fusion, or may have some other beneficial effect. A wide variety of growth factors are contemplated for delivery up to device 10. For example, the growth factor may include a bone morphogenetic protein, LIM mineralization proteins (LMPS), transforming growth factors, such as transforming growth factor β (BGF -β) insulin-like growth factors, growth factors derived from fibroblast growth platelets, factors, or other similar growth factor that has some beneficial effect. If included, growth factors or other pharmacological agents are usually supplied in therapeutically effective amounts. For example, growth factors can be included in amounts effective in promoting fusion.
    In particular, the growth factor is a bone morphogenetic protein, including recombinant human bone morphogenic proteins (rhBMPs). For example, in a way that the bone morphogenetic protein is rhBMP-2, rhBMP-4 or even heterodimers. However, any bone morphogenetic protein is contemplated, including bone morphogenetic proteins designated as BMP-1 through BMP-18. Bone morphogenetic proteins are available from Genetics Institute, Inc., Cambridge, Mass. and it can also be prepared by one skilled in the art, as described in Pat. No. 5,187,076 to Wozney et al .; Pat. No. 5,366,875 to Wozney et al .; Pat. No. 4,877,864 to Wang et al .; Pat. No. 5,108,922 to Wang et al .; Pat. No. 5,116,738 to Wang et al .; Pat. No. 5,013,649 to Wang et al .; Pat. No. 5,106,748 to Wozney et al .; and PCT Patent Nos. W093 / 00432 to Wozney et al .; WO94 / 26893 to Celeste et al .; and WO94 / 26892 for Celeste et al. All bone morphogenic proteins are contemplated if obtained as above or isolated from the bone. Methods for isolating bone morphogenetic protein from bone are described, for example, in Pat. No. 4,294,753 to Urist and Urist et al., 81 PNAS 371, 1984.
    In other forms, the pharmacological agent may be one that is used to treat various spinal conditions, including infected spinal cords, cancer of the spinal cord and osteoporosis. Such agents include antibiotics, analgesics and anti-inflammatories, including steroids, although other exemplary agents are known to those skilled in the art.
    These agents are also used in therapeutically effective amounts that will treat the various conditions and symptoms that they cause and can be determined by the skilled artisan, depending on the specific case.
    In another non-illustrated embodiment, an implant includes exposed areas of an osteoconductive or osteoinductive material and a biologically stable material on its outer surface where the osteoconductor or osteoinductor is suspended or dispersed throughout the biologically stable material. More particularly, in such a way, the particles of a bioactive ceramic material, such as Skelite ®, can be homogeneously mixed with a biologically stable material, such as a biologically stable polymeric material including for example the members of the polyaryethylketone family (Paek) , such as polyetheretherketone (PEEK), carbon reinforced PEEK, and polyetherketonacetone (PEKK). The homogeneous mixture can be molded by injection, extrusion or compression molded in the desired configuration of the implant or a blank from which the desired configuration of the implant can be obtained through further processing, such as either a combination of cutting, machining, chemistry degradation, engraving, grinding, and hammering, just to give some non-limiting examples. Exposed areas of osteoconductive or osteoinductive material in general can promote accelerated fusion rates and provide early implant fixation through bone fixation, while biologically stable material continues to provide the mechanical properties necessary for the anatomical location in which the implant is used.
    In another embodiment, an implantable medical device includes a body having an external surface defining an external profile of the device. The outer surface includes one or more exposed areas of a porous matrix exhibiting a series of interconnected macropores and a biologically stable filler material substantially filling at least a portion of the series of interconnected macropores. After implantation, the porous matrix undergoes a remodeling process in which the activity of osteoclasts progressively removes portions of the porous matrix and activity of osteoblasts progressively replaces the portions removed from the porous matrix with new bone tissue. In one or more aspects of this modality, the beginning of the remodeling process is limited to one or more exposed areas of the porous matrix on the external surface of the device. In another aspect of this modality, the porous matrix is formed by Skelite ® and the biologically stable material is selected from polyetheretherketone (PEEK), carbon reinforced PEEK, and polyetherketone acetone (PEKK).
    In yet another embodiment, an implant includes a ceramic matrix having openings that are, in whole or in part, filled with a biologically stable filler. The implant also includes an external surface dispersed throughout its outer profile. In such a way, the external surface around the entire external profile of the device is defined by exposed areas of the matrix and the biologically stable filling material. Alternatively, he declared, the outer surface is defined by a discontinuous arrangement of interspersed areas of the matrix and the biologically stable filling material. In another form of this modality, the ceramic matrix is formed by Skelite ® and the biologically stable material is selected from polyethercetone (PEEK), carbon-reinforced PEEK, and polyethercetonacetone (PEKK), despite alternative materials for the ceramic matrix and filling material to be contemplated.
    In another embodiment, methods of stabilizing and promoting fusion between adjacent bones or bone portions along a load structure axis are provided. For example, in a modality form this method includes providing an implant, preferably a loading implant, such as device 10 described above, and preparing the adjacent vertebrae to receive the implant in an intervertebral disc space between the adjacent vertebrae . These methods of preparation are well known to those skilled in the art, and may include the total or partial removal of the intervertebral disc, including all or a portion of the fibrosis ring or the pulpal nucleus. The implant can be placed in the space of the intervertebral disc between the adjacent vertebrae after the preparation step.
    EXAMPLES
    The following examples are for illustrative purposes and should not be construed as limiting the invention disclosed in this document to the modalities disclosed in these examples only.
    Example 1
    A blank compound, including a porous matrix formed of a bioabsorbable ceramic material and a biologically stable polymeric material from which an implant, such as device 10, can be obtained has been prepared according to the following.
    A cylindrical, polyurethane foam open pore with a diameter of 25mm and a length of 25mm was used as a precursor to the reticulated model. Two aqueous ceramic suspensions were provided using Skelite ® commercially available from Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. A slurry had a 25% vol. of solids loading and the other at 17% vol. loading of solids. Both fluid pastes had been ground by spheres for 5 hours. The foam material was immersed in 25% vol. slurry solids and agitated to remove air substantially fill the voids with the slurry, and to coat the foam structures with the slurry. The resulting impregnated foam was removed from the slurry and placed on a mesh screen that was attached to a vertically mounted vacuum hose. Excessive slurry was removed from the voids, turning on the vacuum unit for 3-5 seconds. This was enough time to remove the excess fluid paste from the foam voids without interrupting the paste that was adhered to the foam structures. The coated foam was oven dried at 120 ° C for 15 minutes. This entire process was repeated 1-2 times more with 25% vol. solid slurry and 4-10 times more with 17% vol. solid fluid paste.
    The dry, coated foam substrate was transferred to an electric oven, where it was heated at a rate of 1 ° C / min to a temperature of 500 ° C to expel water and allow the polyurethane foam to pyrolyze without going into collapse the porous ceramic matrix. The foam was held at 500 ° C for 4 hours and was subsequently heated at a rate of 1 ° C / min to a temperature of 1500 ° C. This temperature was maintained for two hours to allow the ceramic particles to sinter together thus providing an open cell, porous ceramic matrix having the physical morphology of the original polyurethane foam material. Thereafter, the oven was cooled at a rate of about 36 ° C / min until a final temperature of 25 ° C was reached. The final dimensions of the porous ceramic matrix were about 20 millimeters in diameter and about 20 millimeters in length and the density was approximately 2.9 g / cm3.
    A PEEK injection molding machine was configured with an injection cavity sized to accommodate the porous ceramic matrix. The spread of the mold cavity was selected to ensure homogeneous and uniform filling of the cavity with the porous ceramic matrix in place. The mold temperature was set at approximately 120 - 200 ° C and the barrel temperature was set at about 350-380 ° C. PEEK pellets were then loaded into the deposit of the injection molding machine from where it is fed on demand by a jet through a heater and into the mold cavity via a pin. The PEEK material used was Victrex® PEEK 150G, a semi-crystalline non-reinforced high performance thermoplastic commercially available from Victrex USA, Inc., 300 Conshohocken State Road, Suite 120, West Conshohocken, PA 19428.
    The porous ceramic matrix was loaded into the mold cavity when the injection molding machine was set up with the mold in the open position. The porous ceramic matrix was loaded directly into the mold cavity or the scaffolding was preheated to a temperature of about 230 ° C prior to placement in the mold, as preheating reduces while PEEK cools when it comes into contact with the matrix porous ceramic. The porous ceramic matrix geometry is such that the outer profile substantially fills the mold cavity. The mold of the injection molding machine is then closed, thus fully containing the porous ceramic matrix within the mold cavity.
    In order to impregnate the open spaces of the porous ceramic matrix with PEEK material, PEEK is flowed into the mold cavity at an injection pressure of 1100 psi (7.6 MPa) during a filling time of about seven minutes. Infiltration of PEEK throughout the porous ceramic matrix during injection is assisted by keeping the mold temperature high to reduce the viscosity of PEEK during injection (achieved using a hot Thermolator oil from Budzar Industries, 38241 Willoughby Parkway, Willoughby, OH, 44094 ); using a central pin that directs the PEEK below the center of the porous ceramic matrix, if the porous ceramic matrix has a hollow core, with a flow director inside the hollow core to direct the flow of PEEK in a radial pattern to homogeneously fill the porous matrix ceramics; and preheating the porous ceramic matrix before insertion into the cavity to avoid localized cooling of the PEEK, since it finds the relatively fresh porous ceramic matrix, thus maintaining the reduced viscosity of the PEEK during injection.
    The injection molding tool automatically ejects the white porous ceramic / PEEK composite matrix into the cavity after opening using the injection molding pin ejector pattern. The blank compost is ejected into a collection chamber located below the tool for recovery by the operator and can be later machined to form using practical machining implants that prevent chemical contamination by refrigerants, among other possibilities.
    Any theory, operating mechanism, proof, or find described here is intended to further improve the understanding of this application and is not intended to make this application in any way dependent on such theory, the operating mechanism, proof , or find. It should be understood that while the use of the word preferable, preferably or preferential in the description above indicates that the resource as described may be more desirable, still not necessary and modalities missing from it can be contemplated as covered by the invention, the scope to be defined by the following claims. When reading the claims, it is intended that when words such as "a", "one", "at least one", "at least a portion" are used, there is no intention to limit the claim to just one item to unless specifically stated otherwise. In addition, when the language “at least a portion” and / or “a portion” is used, the item may include a portion and / or the entire item, unless otherwise noted.
    Although the application has been illustrated and described in detail in the drawings and descriptions above, they must be considered as illustrative and not restrictive of character, understanding that only the selected modalities have been shown and described and that all changes, modifications and equivalents that come within the spirit of the invention as defined herein or by any of the following statements are protected.
    权利要求:
    Claims (12)
    [1]
    1. Implantable medical device (10), characterized by the fact that it comprises:
    a body (12) including an external surface (14) defining
    5 an external profile of such a device (10), such a body (12) further comprising:
    a porous matrix (26) including a series of interconnected macropores (30) defined by a plurality of interconnected supports (28); and a filling material (40) filling
    Substantially at least a portion of such series of interconnected macropores (30);
    the supports (28) being hollow, with each support (28) including a hollow interior, wherein said hollow interiors of said plurality of interconnected supports (28) are interconnected and in communication with one
    15 another, thus forming a hollow array of passages (34) extending through the supports (28); and a plurality of openings (36) extending through at least a portion of such an external surface (14) and communicating with such a hollow interior of at least a portion of such a plurality of supports
    20 interconnected (28) to expose the corresponding passages (34), the opening (36) providing an access point for bone and / or tissue grown in a passage (34) of the corresponding support (28), where the bone and / or tissue grown in one pass (34) can spread in additional passages (34) since the passages (34) are interconnected;
    25 wherein said porous matrix (26) comprises a ceramic material and said filler material (40) comprises a polymeric material;
    in which said ceramic material is bioabsorbable and the
    Petition 870180029415, of 12/04/2018, p. 10/33 said polymeric material is biologically stable;
    wherein said ceramic material comprises a calcium-based ceramic; and wherein said polymeric material is selected from group 5 consisting of polyetheretherketone (PEEK), carbon reinforced PEEK, and polyetherketone acetone (PEKK).
    [2]
    2. Device (10) according to claim 1, characterized by the fact that such hollow interiors are isolated from such series of interconnected macropores (30).
    10
    [3]
    Device (10) according to claim 1, characterized in that such hollow interiors of such a plurality of interconnected supports (28) are substantially free of such filler material (40).
    [4]
    4. Device (10) according to claim 1,
    15 characterized by the fact that such a portion of such external surface (14) is defined by a plurality of openings (36), exposed areas of such a porous matrix (26), and exposed areas of such filler material (40).
    [5]
    5. Device (10), according to claim 4, characterized by the fact that such a portion of such external surface (14) is
    20 extends around such an external profile of such a device (10).
    [6]
    6. Device (10) according to claim 4, characterized by the fact that one or more of such exposed areas of such a porous matrix (26) surround one or more of such plurality of openings (36) and isolate such openings ( 36) from an adjacent of such exposed areas in such a way
    25 filler material (40).
    [7]
    7. Device (10) according to claim 1, characterized by the fact that said calcium-based ceramic is selected from the group consisting of calcium sulfate, calcium carbonate and
    Petition 870180029415, of 12/04/2018, p. 11/33 calcium phosphate.
    [8]
    8. Device (10), according to claim 7, characterized by the fact that:
    such calcium-based ceramic is defined by a compound 5 that includes calcium, oxygen and phosphorus; and a portion of at least one such element is replaced the
    with an element having an ionic radius of about 0.1 to about 0.6 A.
    [9]
    9. Device (10), according to claim 8, characterized by the fact that such a compound has the formula:
    [10]
    10 (Ca) i {(P1-x-y-zBxCyDz) Oj} 2:
    where B, C and D are selected from the elements having the
    an ionic radius of approximately 0.1 to 0.4 A;
    x is greater than or equal to zero, but less than 1; y is greater than or equal to zero, but less than 1;
    Z is greater than or equal to zero, but less than 1;
    x + y + z is greater than zero, but less than 1; i is greater than or equal to 2, but less than or equal to 4; and j is equal to 4-δ, where δ is greater than or equal to zero but less than or equal to 1.
    10. Device (10) according to claim 1, characterized by the fact that such filler material (40) substantially fills each of such a series of interconnected macropores (30).
    [11]
    11. Device (10) according to claim 1, characterized by the fact that said body (12) is configured to be
    25 positioned between adjacent bones or bone tissues and said outer surface (14) includes opposing bone engaging portions (18.20) each including a plurality of bone engaging projections (24) structured to engage said adjacent bones or bone tissues.
    Petition 870180029415, of 12/04/2018, p. 12/33
    [12]
    12. Device (10), according to claim 1, said device characterized by the fact that it is an implant device within the structured body to facilitate the fusion between adjacent vertebral bodies.
    Petition 870180029415, of 12/04/2018, p. 13/33
    1/3
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    2021-09-21| B24J| Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)|Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2630 DE 01-06-2021 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/508856|2009-07-24|
    US12/508,856|US9399086B2|2009-07-24|2009-07-24|Implantable medical devices|
    PCT/US2010/043249|WO2011011785A2|2009-07-24|2010-07-26|Implantable medical devices|
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