Implanted medical device

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described is a medical device, containing a case which has an outer surface, forming an external profile of the device. The case contains a porous matrix, containing a group of interconnected macropores, formed by connected to each other spreaders, each of which has an internal cavity. A filling material fills at least a part of the group of interconnected macropores. The external surface of the case contains several holes, connected with the internal cavities of at least a part of the interconnected spreaders.

EFFECT: device is adapted for the stimulation of the bone and/or tissue integration, support of the bone remodelling processes due to the activity of osteoclasts and osteoblasts or for the stabilisation and stimulation of the bone consolidation and/or tissue consolidation in adjacent bones or bone tissues.

12 cl, 4 dwg, 1 ex

 

The level of technology

The present invention relates to implantable medical devices and methods of making and using such devices, particularly, but not exclusively, the invention relates to a device for the stimulation of germination of bone and/or tissue, support the natural process of bone remodeling through the activity of osteoclasts and osteoblasts, and/or to stabilize and stimulate bone remodeling and/or tissue in the adjacent bones or bony tissues.

To stabilize and stimulate healing of bone and tissue in the adjacent bones or bony tissues of the patient were used in various kinds of devices, implants and systems. In one embodiment, used implants or devices made of autograft (bone removed from the patient's body) or allograft (bone taken from another person), due to the presence of osteoinductive and/or osteoconductive properties. However, when using autograft and allograft could observe various complications. For example, when use of autograft is a high probability of complications in relation to the donor site, it is necessary to conduct a painful second surgery to collect the material, and not a large amount of bone for transplantation, while when using allot�of spuntata there is a risk of disease transmission, there are difficulties in obtaining and processing of the material, the unknown outcome of the immune response and are at risk for premature resorption. In addition, various factors associated with the anatomical space in which the implant is implanted or device, such as, for example, a compressive load may complicate transplantation of autograft or allograft and/or cause unwanted side effects when using autograft or allograft.

Although advances in the stabilization and splicing of adjacent bones or bony tissues has allowed science to make steps in the right direction, there remains a need for further development of the art.

A brief summary of the invention

One non-limiting embodiment of the present application directed to the creation of implantable medical devices. According to one aspect of this embodiment the device is adapted to stimulate the germination of bone and/or tissue, support the natural process of bone remodeling through the activity of osteoclasts and osteoblasts or to stabilize and stimulate bone remodeling and/or tissue in the adjacent bones or bony tissues, but also disclosed a device that is capable of providing a combination of some or all of oksanakost.

In another embodiment, implantable medical device includes a housing containing an outer surface forming the outer profile of the device. The housing also contains a porous matrix containing a group of interconnected macropores formed by several interconnected struts, each of which has an inner cavity. Material-filler essentially fills at least a portion of the interconnected macropores. Some holes are at least over the area of the outer surface and communicated with the inner cavity of at least parts of several interconnected struts. According to another aspect of this embodiment of the outer surface formed several holes, open areas of the porous matrix and the open areas of the material is filler. According to another aspect of this embodiment of a porous matrix made of a ceramic material, and the material-the filler is a polymeric material. According to another aspect of the ceramic material is bioresorbable, polymeric material is biologically stable. According to another aspect of the material-the filler is embedded throughout and essentially fills every macropore of a group of interconnected m�croper.

In another embodiment, the method includes providing an implantable medical device that includes a housing containing an outer surface forming the outer profile of the device. The housing also contains a porous matrix containing a group of interconnected macropores formed by several interconnected struts, each of which has an inner cavity, the material is filler, essentially filling at least a portion of the interconnected macropores; and several holes passing at least a portion of the outer surface and communicating with the internal cavity, at least part of several interconnected struts. The method also includes placing the device between adjacent bone portions. According to another aspect of this embodiment of the device is placed between the adjacent bony portions includes the introduction of the device into a disc space between the bodies of adjacent vertebrae.

In another embodiment, implantable medical device includes a housing containing an outer surface forming the outer profile of the device. The housing also contains a bioresorbable ceramic matrix containing a group of interconnected macropores formed by several connected�prisoners who had been interconnected by struts, which, in turn, form several interconnected passages, separated from the group of interconnected macropores. Biologically stable polymeric material embedded throughout and essentially fills the group of interconnected macropores, and many interconnected passages essentially do not contain polymeric material. According to one aspect of this embodiment, at least a part of several interconnected passages pass through the outer surface of the housing and open it. According to another aspect of this embodiment the body is made with possibility of placement between adjacent bones or bony tissues, and the external surface includes spaced opposite each other plots, siteplease bone, each of which contains several tabs, saralaya bone, made with the possibility of engagement with the adjacent bones or bony tissues.

In another embodiment, a method of manufacturing a medical implant comprises providing a bioresorbable ceramic matrix containing a group of interconnected macropores formed by several interconnected struts and interconnected struts contain several interconnected internal passages inside �shown spacers; the introduction of ceramic matrix biologically stable polymeric material to obtain the composite workpiece; and processing the composite billet to obtain the body of the implant, comprising an outer surface forming the outer profile of the desired configuration and shape for implantation, and treatment involves the removal of at least part of the interconnected internal passageways to the outer surface. According to another aspect of this embodiment of the outer surface also includes one or more exposed areas of the polymer material and one or more exposed areas of the ceramic matrix.

In another embodiment, implantable medical device includes a housing having an outer surface forming the outer profile of the device. The outer surface includes one or more exposed areas of the matrix that contains one or more holes, and biologically stable material filler, essentially filling at least a portion of one or more holes. After implantation, the matrix undergoes a process of remodeling, in which osteoclast activity provides for the gradual removal of sections of the matrix and osteoblast activity provides gradual replacement remote areas of newly formed bone matrix TC�new. Initiation of the remodeling process is usually limited to one or more open areas of the matrix. According to one aspect of this embodiment of the initiation of the remodeling process is limited to the areas of the matrix that are open during the implantation of the device or to her. According to another aspect of this embodiment of the remodeling process gradually replaces the matrix, starting from the outer surface and gradually moving inwards, towards the inside of the machine, until then, until the whole or essentially the whole matrix is not replaced by new bone tissue. According to another aspect, the matrix is made of a material Skelite®, a biologically stable material-the filler is selected from the group comprising polyetheretherketone (PEEK) reinforced with carbon fiber PEEK, and polyetherketoneketone (PEKK).

Another embodiment of the present application aims to provide a unique device for stabilizing adjacent bones or bony tissues. Other options for implementation include unique methods, systems, devices, equipment and/or facilities designed to promote germination of bone and/or tissue to the stimulation of the natural process of bone remodeling by supporting the activity of osteoclasts and osteoblasts and/or to stabilize and intergrowth of adjacent bones or bony tissues. In other in�the execution options, assumed other forms, and scope of the present invention.

Other options for implementation, forms, features, aspects, positive effects, objectives and advantages of the present invention will be apparent from the following detailed description and accompanying drawings.

Brief description of the drawings

Fig.1 shows a photographic image of one embodiment of implantable medical device.

Fig.2 shows a photographic image of the porous matrix contained in the implantable medical device shown in Fig.1.

Fig.3 and 4 are enlarged photographic image of the porous matrix, shown in Fig.2.

Fig.5 shows an enlarged photographic image illustrating the outer surface of the implantable medical device shown in Fig.1.

Description of illustrated embodiments of the

In order to facilitate understanding of the principles of the invention, will be described below embodiments of shown in the drawings, and will be used specific terms to describe them. However, it should be understood that the description is not intended to limit the scope of the invention. Any changes or further modifications of the illustrated devices and described methods, and also� great options of applying the principles of the invention, presented in the description, can be performed, as is obvious to a specialist in the field to which the invention relates.

Provided implantable medical devices, implants and methods of making and using these devices and implants. In particular, in one embodiment, provided with the device stimulating the germination of bone and/or tissue, stimulating the natural process of bone remodeling through the activity of osteoclasts and osteoblasts, stabilizing adjacent bones or bone tissue, and/or stimulating the regeneration of bone or tissue in the adjacent bones or bony tissues, but also disclosed a device that is capable of providing a combination of some or all of these properties. According to one particular aspect of this embodiment of the device has mechanical properties that mimic the properties of bone and is able to withstand a compressive load in the selected anatomical region, such as the area between adjacent bones or bony tissues. Usually, the device according to the present embodiment includes a porous matrix made of osteoconductive and/or osteoinductive material, such as ceramics based on calcium, which after implantation can eventually undergo resorption. In one particular embodiment,the matrix is made of ceramic material, undergoing remodeling process, which is essentially similar to certain aspects of the natural bone remodeling process. In particular, in this embodiment, the ceramic material is gradually removed through the activity of osteoclasts, and the removed portion of the ceramic material is gradually replaced by newly formed bone through the activity of osteoblasts. Further details of the specified property described below. The porous matrix also contains a group of interconnected macropores formed by several interconnected struts, and each of the struts has an inner cavity, further description of which is given below. At least a portion of the interconnected macropores is essentially filled with a material-filler, but in other embodiments, in each of macropore from the group of interconnected macropores embedded material filler, essentially filling her, and the inner cavity of interconnected struts remain essentially open and devoid of material or filler. In one embodiment, the material of the filler may be biologically stable, such as a biologically stable polymeric material. In the present description, the term "biologically stable" refers to materials that remain essentially intact or not exposed to resorb�AI when implanted in a biological environment, and after said implantation. However, in another embodiment considers the possibility that the material of the filler may be bioresorbable and can undergo resorption in parallel with the resorption of the porous matrix or after resorption of the porous matrix. In one embodiment, the device also includes an external surface having multiple openings extending through it and communicating with an internal cavity or cavities at least part of the multiple struts.

Thus, the entire outer surface of the device or part is made in such a way that it contains one or more open areas of the porous matrix made of osteoconductive and/or osteoinductive material, and one or more open sections of the material is filler in addition to the open holes, communicating with the internal cavity, at least part of the spacers. Among other features, this configuration provides a total external surface area, can be accompanied by the bond and connection of bones in an open area or areas of the porous matrix, as well as the germination of bone and/or tissue and penetration into the device through holes communicating with the internal cavity at least part of the interconnected struts. These features are capable of, among other things, to provide more robust Zap�finally the device between adjacent bones or bony tissues to facilitate the knitting of adjacent bones or bony tissue and/or reduce the time period required for the coalescence of adjacent bones or bony tissues. Moreover, the apertures communicating with an internal cavity, at least part of interconnected struts, usually allow the fabric to quickly infiltrate the device, thereby providing an earlier fixation device during the healing period after implantation. According to another aspect, wherein the osteoconductive and/or osteoinductive material after implantation over time undergoes resorption, gradual integration of devices with resorbable porous nature of the matrix, increases the degree of fastening and locking devices, which is achieved through the early introduction of bone and/or tissue in the inner cavity of struts.

In addition, in the embodiment in which the porous matrix is made of ceramic material, subjected to the process of remodeling, which is essentially similar to certain aspects of the natural bone remodeling process, the device includes a surface chemical processes, stimulating the activity of osteoclasts, enabling the connection and formation of bones in an open area or areas of the porous matrix, as well as on the inner surfaces of the inner�Enni cavities spacers. In particular, osteoclast activity helps to ensure the gradual replacement of sections of the porous matrix, open on the outer surface of the device and along the inner surfaces of the hollow struts. Then through the activity of osteoblasts remote areas of the porous matrix, respectively, and is gradually replaced by newly formed bone tissue. Similarly, the internal cavity of interconnected struts provide additional exposure of the material to ensure the activity of osteoclasts and associated osteoblasts, allowing to gradually replace the material of the porous matrix of newly formed bone tissue. In the same way, increasing the locking device between adjacent bones or bony tissues, germination and tissue in the interior cavities progressing as remodeling of the porous matrix.

In addition to this description, it should be noted that the material of the filler provides a reliable surface that can support the adjacent bones or bone tissue. Material filler also gives the device a high fracture resistance and modulus of elasticity similar to the dice module, thus strengthening a porous matrix, whereby the device is capable of supporting the load and the voltage normally present at various points of the skeleton in addition, if osteoconductive and/or osteoinductive material can eventually be resorbed, and the material of the filler is biologically stable, it is able to continue to provide a support for the adjacent bones or bony tissues after resorption of the porous matrix. Indeed, in this embodiment, a biologically stable material filler essentially turns into a porous matrix, in which and through which bone and/or tissue is introduced simultaneously with the resorption of the porous matrix, or after its resorption. Additional details regarding these or other details of the device disclosed and described herein below.

In an alternative embodiment, is provided a device comprising a housing made of a ceramic matrix containing one or more holes and biologically stable material filler, essentially filling at least part of the holes, but in one or more embodiments, it is assumed that biologically stable material filler can be embedded all over in all holes and may basically fill it out. In one form of this embodiment, the holes formed by a group of interconnected macropores. However, in another embodiment, the openings formed by channels or passages, partially penetrating into the body, or through it. In another VA�iante, the ceramic body is defined or structured geometric shape in the form of a frame, forming a hole. In one form of this embodiment, the device comprises an external surface forming the external profile of the device and contains one or more exposed areas of the ceramic matrix material and filler, but you must understand that the entire outer surface may be formed in the open areas of the ceramic matrix material and filler. Ceramic matrix made of ceramic material, subjected to the process of remodeling, which is essentially similar to certain aspects of the natural bone remodeling process. In particular, in this embodiment, the ceramic material is gradually removed through the activity of osteoclasts and remote areas of ceramic material is gradually replaced by newly formed bone through the activity of osteoblasts. Similarly, after implantation of the device ceramic matrix undergoes a process of remodeling, in which osteoclast activity provides for the gradual removal of sections of ceramic matrix and osteoblast activity provides gradual replacement remote sites ceramic matrix of newly formed bone tissue. According to one �the range of this embodiment of the initiation of the remodeling process is limited to the areas of the ceramic matrix, exposed on the outer surface of the device. In particular, it is necessary to understand that the ceramic matrix will be remodelormove in newly formed bone tissue in the process, starting with the outer surface of the device and over time, gradually continuing on plots closer to the inner part of the device or parts within it. Similarly, as the material is filler in this embodiment is biologically stable, the progress of remodeling to the interior of the device or inside it can have its starting point only the exposed areas of the ceramic matrix on the outer surface of the device. According to another, more specific aspect of this embodiment of the initiation of the remodeling process may be limited to sections of the ceramic matrix and exposed on the outer surface of the device during implantation or before.

Although not described above, the ceramic matrix according to this embodiment also contains a number of interconnected struts forming the holes. Unlike the embodiment described above, in this embodiment assumes that each spacer may be solid or filled cross section, but the options in which each strut has an inner cavity is also possible. Similarly, depending on ceramic matrix, it is assumed that in one or more embodiments, the outer surface of the device in this embodiment may be provided with holes passing through the internal cavity or cavities at least parts of several struts and connecting with those braces.

Similar to the variant of implementation described above, the device according to this embodiment can stimulate the germination of bone and/or tissue, stimulate the natural bone remodeling process by supporting the activity of osteoclasts and osteoblasts, to stabilize the adjacent bones or bony tissue and/or stimulate the regeneration of tissue between adjacent bones or bony tissues. According to one particular aspect of this embodiment of the device has mechanical properties that mimic the properties of bone and is able to withstand a compressive load in the selected anatomical region, such as the area between adjacent bones or bony tissues. Additionally, the outer surface of the device according to this embodiment comprises the surface chemical processes, allowing to initiate the connection process and the formation of bones in an open area or areas of the ceramic matrix, and then continue on�umiestnenie process closer to the inner parts of the device or in them. In the same way, increasing the locking device between adjacent bones or bony tissues, and the germination of the tissue in the device progresses as remodeling ceramic matrix.

In addition, biologically stable material in this embodiment provides a reliable surface that can support the adjacent bones or bone tissue. Material filler also gives the device a high fracture resistance and modulus of elasticity similar to the dice module, thus strengthening a ceramic matrix, whereby the device is capable of supporting the load and the voltage normally present at various points of the skeleton. Also with the gradual remodeling and replacement of ceramic matrix of newly formed bone material filler may continue to provide a support for the adjacent bones or bony tissues. Additional details regarding these or other details of the device disclosed and described herein below.

It is assumed that the above-described devices can be used anywhere in the skeleton and can be used in various areas where it is required or desirable to repair or growth of bone or tissue. In one more specific, but non-limiting embodiment, the device may be adapted for placement between adjacent �awns or bone tissues with the aim of providing support along the axis of the bone or bone tissue, carrier weight load, although it is also assumed options to use without the weight load. For example, as shown in Fig.1, the photo shows the end view of the interbody device implant 10 configured to facilitate fusion of adjacent vertebral bodies. The device 10 typically contains a D-shaped body 12 made for placement in a disc space between adjacent vertebral bodies. The housing 12 also has an outer surface 14, passing through an external profile corresponding to the shape of the device 10. The device 10 also includes a side wall 16, passing around and surrounding a hollow chamber 22 in which may be placed reinforcing bone growth materials, such as bone chips, bone morphogenetic protein, LIM-mineralization proteins (note - the name of the LIM is derived from three open source proteins Lin11, Isl-1, Mec-3, therefore, is not translated into Russian language), and other growth factors. The outer surface 14 is located opposite to each other of the upper and lower portions 18, 20, made with the protrusions 24 formed for engagement with adjacent vertebral bodies and counteract the buoyancy of the device 10 out of disk space. In one or more embodiments, the upper and lower parts 18, 20 can be arranged at an angle relative to each other, providing a configuration suitable for�pulling the corner of lordosis between the adjacent vertebral bodies, between which will be placed in the device 10. In addition, although not shown in the drawings, it should be understood that the device 10 may be provided with one or more of the sites for interaction with tools that can facilitate the engagement and placement of the device into a disc space using a suitable tool. It is also assumed that the device 10 can be provided with an alternative external configurations, non-limiting examples of which are disclosed in U.S. patents№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, as well as in patent publication U.S. No. 2008/0161927.

As also shown in Fig.1, the device 10 contains a matrix 26 and the material of the filler 40 that is embedded throughout in the holes of the matrix 26. In particular, in the illustrated embodiment, the material of the filler 40 is embedded in the hole formed by macro-pores of the matrix 26, and extent. However, in another embodiment, the die holes 26 can be formed by the channels or passages, partially penetrating into the matrix or through it. In one embodiment, the matrix 26 is defined or structured geometric shape in the form of a frame, forming a hole. However, in other neprogruntovannye forms, material-napolnitel� 40 essentially fills only a portion of the holes of the matrix 26. In the illustrated embodiment, housing 12 includes exposed areas of matrix 26 and the material of the filler 40 around and along its external profile and the outer surface 14. In particular, the outer surface 14, including segments passing around the external profile and of the same shape of the device 10 (including the inner cavity 22), contains the exposed areas of matrix 26 and the material of the filler 40. Also, although not shown in Fig.1, the housing 12 also contains several openings around and along its external profile and the outer surface 14, additional details of the structure which will be given below with reference to Fig.5. Holes are usually placed in different points of the exposed areas of matrix 26 and communicate with the internal cavities of the struts of the matrix 26. However, in other embodiments, the struts of the matrix 26 can be performed without internal cavities and to have a solid or filled cross section. Similarly, in this embodiment, the outer surface 14 does not contain through holes. However, in other embodiments, it is assumed that the struts of the matrix 26 may be hollow, but the outer surface 14 contains through holes, or the outer surface 14 may contain holes on only one or more desired areas. In other neprogruntovannye preferred embodiments�laga, that only a portion or certain portions of the outer surface 14 may be provided with exposed areas of matrix 26 and the material of the filler 40. For example, in one such embodiment, the outer surface 14 may be provided with exposed areas of matrix 26 and the material of the filler 40 along the upper and lower parts 18, 20. In another example, the outer surface 14 may be provided with exposed areas of matrix 26 and the material of the filler 40 along an area of the side wall 16 near the camera 22. Nevertheless, as will be obvious to the expert, there may be other configuration host exposed areas of matrix 26 and the material of the filler 40 along the outer surface 14.

Fig.2 shows a photographic image of the matrix 26, which provides a framework that can be embedded in the material of the filler 40, but the material of the filler 40 is absent in the matrix 26, as shown in Fig.2. The matrix contains 26 multiple struts 28, which form a group of interconnected pockets or macropores 30. Only a portion of the struts 28 and macropores marked 30 in Fig.2 to preserve clarity. In the embodiment shown in Fig.2, the matrix 26 essentially has a hollow cylindrical shape, but it is assumed that the device 10 may be used in other configurations of the matrix 26. Each strut 28 of the matrix contains 26 EXT�NYY cavity or passage 34, which can be seen in enlarged photographic images of the matrix 26 in Fig.3 and 4. The passages 34 of the spacers 28 are connected together and are in fluid communication with each other, thereby forming a hollow matrix of passages 34 extending through the spacers 28. Similarly, the passages 34 is usually separated from the group of macropores 30 sidewalls of the spacers 28, but it is assumed that there is some degree of communication between passages 34 and macro-pores 30 through the micropores 32 (Fig.4) on the struts 28. Part of the passages 34 is open in Fig.3 and 4 for illustrative purposes and clarity, but it should be understood that the passages 34 will not normally be open in the original manufacture of the matrix 26, as the ends of the struts 28 are essentially closed, which is obvious when considering the manufacturing process of the matrix 26, as described below. Instead, in the further processing may be removed part of the material at the ends of the struts 28, thereby exposing the passages 34. Due to this, one or more sections of the matrix 26 may be filled with resin filler 40, but it does not fill the passages 34 material-filler 40. Similarly, when one or more sections of the matrix 26 is filled with a material of the filler 40, the passages 34 remain essentially free from material filler 40, except for the possible case�Oh leak, which may arise through the micropores 32, is not completely closed end of the strut 28, or any other random cracks or defects. In the case of device 10, in one embodiment, the passages 34 can be opened after the introduction of the material-the filler 40 in one or more areas of matrix 26 and after the formation of the final configurations of the device 10, further details of which are given below.

In other embodiments, the matrix 26 may be provided with spacers 28 that do not contain internal cavities. Instead, in such configurations, spacers 28 are made of the same material as the matrix 26, and having substantially solid cross-section. Similarly, when one or more sections of the matrix 26 is filled with a material of the filler 40, the material usually does not penetrate or does not fill any portion of the spacers 28. In addition, as noted above, the matrix 26 may also be designed in such a way that it contains one or more channels or passages that are partially in the body, or through it to form the die holes 26 instead of macropores 30. Additionally, in one embodiment, the matrix 26 is defined or structured geometric shape in the form of a frame forming the die holes 26.

The matrix 26 may be made of sintered or respecing composite ceramic processing�die material, being synthetic, natural, bioresorbable or prasarbharati. According to one aspect of this variant of ceramic material, which radioveronica, device 10 provides the necessary imaging properties even after one or more sections of the matrix 26 is filled with resin filler 40. In one particular embodiment, the matrix 26 is made of a sintered ceramic material with osteoconductive and/or osteoinductive properties, bioresorbable, or biodegradable in vivo. In other words, the ceramic material is a bioactive material in the sense that it is able to cause a biological response on its surface, which leads to the formation of ties with neighboring tissue.

Non-limiting examples of the ceramic material include ceramics based on calcium, such as calcium sulphate, calcium carbonate; or material of calcium phosphate, such as hydroxyapatite, carbonate-Apatite, florouracil; or tricalcium phosphate, such as α-tricalcium phosphate or β-tricalcium phosphate, tetracalcium, actualitzat, as well as mixtures of these materials. In one particular embodiment, the matrix 26 may be formed from a bioresorbable or biodegradable ceramic material subjected to the process of re�of modelirovaniya, aspects of which are essentially similar to certain aspects of the natural bone remodeling process. Thus, unlike other ceramic materials, having the properties of non-specific dissolved, which adversely affects the structural properties of the original joints, ceramic material according to this embodiment follows the principles of cell remodeling, providing polymorphic but stable interaction with the tissues of the recipient to maintain a local structural functioning throughout the process of bone replacement. For example, in this embodiment, the ceramic material is gradually removed through the activity of osteoclasts, where microarchitecture remote sites of a ceramic material and gradually simpaticeskii is replaced by newly formed bone through the activity of osteoblasts. In particular, the surface of the matrix facilitates the formation of a boundary connection through the activity of bone cells that form the extracellular matrix that hardens due to the subsequent mineralization. One particular variant of a ceramic material subjected to the process of remodeling, which is essentially similar to certain aspects of the natural bone remodeling process is Skelite® representing isolera�this bioresorbable biomaterial, provided by the company Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. In particular, Skelite® is a compound containing calcium, oxygen and phosphorous, wherein a portion of at least one of the specified elements are replaced by an element having an ionic radius of approximately 0.1 to 0.6 Å. Non-limiting examples of such elements include silicon and boron, but can also be other items that match this criteria. More precisely, the biomaterial has the formula

(Ca)i{(P1-x-y-zBxCyDz)Oj}2:

where b, C and D is selected from elements having an ionic radius of approximately 0.1 to 0.4 Å;

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 or equal to 2 but less than or equal to 4; and

j equals 4-δ, where δ is greater than or equal to zero and less than or equal to 1.

Further details regarding this connection can be found in U.S. patent No. 6,323,146, the content of which is incorporated in this application by reference in its entirety.

In regard to the illustrated version of the matrix 26, it can be made of organic lattice foam structure having multiple interconnected pockets. In particular, in one embodiment, poly�retinova foam is exposed to the instantaneous firing to break and remove the thin walls between the gas bubbles in the foam structure, thereby creating a sponge, the pores of which are connected to each other and not closed. Porous foam structure specified configuration available on the market, but may want to be prepared, and facilitate the formation of the passages 34 of the struts 28. In embodiments where the spacers 28 are hollow, the matrix 26 may be manufactured using preobrazuemogo agent, such as polymer spheres in contact at the time of introduction of the ceramic material in a matrix and then removed during the sintering of the matrix. In the foam structure are introducing a liquid suspension of ceramic material in such a way that the ligaments or struts of the foam are covered with the specified material, and the pockets are essentially filled. Excess slurry is removed from the pores of, and coated with a material design dried, thereby obtaining the so-called raw (i.e. nespechennogo foam covered with material design). Drying may take from several minutes to over an hour, that will be obvious to the specialist. The process is repeated until then, until the coating of the slurry reaches the desired thickness in the foam structure. Typical coating thickness may be from about 10 to about 100 microns. Coated structure is heated to first burn out the flexible organic foam and then sintered, thereby forming a fused ceramic foam having several interconnected pockets in the form of macropores 30. Heating is usually carried out at temperatures from about 25 ° C to about 500º. Sintering is usually carried out at temperatures from about 900 ° C to about 1500º.

Heating and sintering can be done in a row, in this case the temperature reaches values directly from sintering heating values.

Preparation of a suspension of ceramic material includes mixing a ceramic material with a liquid medium which is usually water, and a dispersing agent. Dispersing agents can be used to prevent agglomeration of the ceramic particles and can be organic or inorganic. Examples of the organic dispersing agents include sodium polyacrylate, ammonium polyacrylate, sodium citrate, sodium tartrate, and mixtures of these substances. Examples of the inorganic dispersing agents include sodium carbonate, sodium silicate, tetrasodium pyrophosphate and mixtures of these substances. The amount of added dispersing agent is typically (but not limited to) from about 1 to 3.5% by volume.

It was found that the initial particle size of the ceramic material can affect the final strength of the matrix 26. In addition, the particle size can also affect both the solids and the final viscosity of the suspension. Crushing parts suspension was �the estate to obtain the desired particle size distribution of the particles. Usually, suspension part, you can split up within 1 to 24 hours, using inert, durable abrasion of the crushing environment, such as alumina or Zirconia, which allows to obtain ceramic particles up to about 50 microns (and any size or range of sizes up to 50 microns). To ensure adhesion of the ceramic particles of the slurry to a foam substrate and to each other, preferably after reducing the particle size of the suspension was thixotropic. In other words, the suspension viscosity decreases with increasing shear stress.

In a suspension of ceramic material can also be added additives before it will be entered into a reticulate body foam. Non-limiting examples of such additives include a binder to strengthen the raw moisturizer to improve distribution of slurry on the foam, and antifoaming agent that reduces the formation of bubbles in the suspension. These components are usually added to the slurry in small quantities, including but not limited to less than 10% by volume for a bonding agent, and less than 2% by volume for moisturizing and antifoaming agents.

The matrix 26 may be given a compressive strength of about 10 MPa by applying several layers of a slurry of a ceramic material and drying the filled con�trucchi in between coats. Despite the fact that the porous structure of the foam may begin to clog when applying the last layer, it was found that using a slurry with a high content of solids (up to about 30% by volume) when applying the first several layers, then multiple coats of a slurry with a lower solids content (below about 20% by volume) helps to avoid blockage.

In one embodiment, for removing excess slurry from the housing foam can be used in a vacuum process. In this case, the filled foam is then placed on a sieve, attached to the top of a vertically mounted suction hose, and the extra suspension is pulled through the hose into the vacuum unit. In another embodiment, for dispersing excess slurry, overlying the inner pores may be used gas flow is controlled.

To remove foam construction dried up and covered the structure can be transferred to an electric furnace, to heat and hold at a sufficiently high temperature (i.e., approximately to 200) for the initial removal of water, and then hold at a higher temperature (e.g., approximately 500º) to carry out pyrolysis of the underlying polymeric foam. Subsequent sintering ceramic design (at a temperature of approximately 1500º, more preferably from at�Erno to about 1200ºC 1500º) is performed by heating to a temperature significantly higher than the temperatures used for pyrolysis of the foam. Then the furnace is allowed to cool to room temperature.

Although not described above, you must understand that one or more properties of foam structures can be modified to ensure that the matrix 26 structural properties desirable for one or more variants of the device 10. For example, in one embodiment, the foam structure may be provided with varying parts of the pockets, allowing the matrix 26 of this type, in which as a result, the ratio between the matrix material and the filler will focus on certain characteristics of strength and modulus. According to one aspect of this embodiment, for example, it is assumed that the sizes of the macropores foamy structure can be modified, which, in turn, will change the location of the struts 28 of the matrix 26. In another embodiment, it is assumed that the foam structure can be provided with an anisotropic configuration, which in the end will impart anisotropic properties of the matrix 26. Similarly, the device 10 may be formed with the matrix 26 having anisotropic properties, and therefore, the device 10 will also have anisotropic properties that provide the desired mechanical characteristics in one or more selected n�the boards, similar to natural bone. According to one aspect of this variant of anisotropic properties can be obtained from foam design, which includes a gradient porosity or elongated macropores. For example, the foam structure can be heated, to stretch or compress with a view to lengthening macropores, and then cooling, resulting in macropores retain an elongated configuration. In another example, a gradient porosity can be obtained by combining two or more foam structures with macropores of different size, but also may consider other approaches.

It is also assumed that the foam structure can be changed so that as a result of one or more sections of the device 10 are made of one material surrounded by a matrix material 26 and the filler 40. For example, part of the foam structure can be removed from one or more sections and then these sections can be coated with ceramic material, the material of the filler 40 or other material. In one particular embodiment, a plot is made of the same material, can be used on the ground of the device 10, using a thread connected to the device for placement during implantation of the device 10, but assumed other uses for one�about or more parcels, made from the same material. In addition, it is also assumed that foamy design can be performed using the three-dimensional printing process to ensure an organized or non-random arrangement of ligaments or struts. In this embodiment, the foam structure may be formed in the rope of a network of open cells, where the ligaments can be positioned in such a way that they form a configuration which imparts the desired mechanical properties of the matrix 26 and, accordingly, the machine 10.

In the preparation of the illustrated variant of the device 10, the material of the filler 40 in introducing group macropores 30 and throughout the process once prepared, the matrix 26. However, as noted above, in other embodiments, the material of the filler 40 adopting only part of macropores 30 matrix, filling them. In such configuration, one or more sections of the device 10 may be provided with exposed areas of matrix 26, devoid of the material of the filler 40, thereby providing a higher degree of openness of the matrix 26 and an open network that can grow tissue. The material of the filler 40 usually strengthens the matrix 26, whereby the device 10 is able to withstand the load and stress, often occurring at different points of the skeleton, and has mechanical properties, more �part mimic natural bone, than would be possible using only one matrix 26. For example, the material of the filler 40 may provide device 10 with high fracture resistance and modulus of elasticity similar to the elasticity modulus of the bone. In one embodiment, the material of the filler 40 is a biologically stable polymeric material, but you can use other types of biologically stable materials. Non-limiting examples of biologically stable polymeric materials include polyethylene, polymethylmethacrylate, polyurethane, polysulfone, polyetherimide, polyimide, ultrahigh molecular weight polyethylene (UHMWPE), crosslinked UHMWPE, and representatives of a number of polyaryletherketones (PAEK) including polyetheretherketone (PEEKK), reinforced with carbon fiber PEEK, and polyetherketoneketone (PEKK). In another embodiment, it is assumed that the material of the filler 40 may be a bioresorbable or biodegradable polymer material, but may use other types of bioresorbable or biodegradable materials. According to one aspect of this variant, the material of the filler 40 may be provided in the form of having the period of disintegration in vivo, equal to or slower than the period of disintegration of the matrix 26, if it is made of a bioresorbable or biodegradable material. Non-limiting examples of bioresorbable or biodegradable polymer mater�materials include poly(L-lactide), poly(L-co-D,L-lactide), polyglycolide, poly(lactide-co-glycolid), poly(hydroxybutyrate), poly(hydroxyvalerate) derived from tyrosine polycarbonate, polyanhydride, polychaetes, polyphosphazene, poly(dioxanone), poly(ε-caprolactone) and polyglycolic.

In one or more embodiments, the material of the filler 40 may be formed as a composite material, for example made of polymeric material and one or more osteoinductive and/or osteoconductive materials. For example, in one particular embodiment, the material of the filler 40 may be formed from a mixture of polymeric material and particles of ceramic material from which the matrix 26, but it is assumed that can be used and other options ceramic or osteoinductive and/or osteoconductive materials. In this embodiment, the material of the filler 40 may be provided with additional open areas osteoinductive and/or osteoconductive materials in order to facilitate the additional connecting bones and/or increasing the bioavailability of mineral elements, lamivudine from the device 10. In addition, in one or more embodiments, it is also assumed that the cells that are in contact with particles of osteoinductive and/or osteoconductive materials in the material-the filler 40 may be subjected to stimulation and after�effects that may contribute to the initiation of the process of bone repair.

It is assumed that the material of the filler 40 can be introduced to fill all or part of macropores 30 of matrix 26 by any suitable method. However, in one particular embodiment, the macropores 30 can be filled with resin filler 40 by a molding process. For example, the matrix 26 may be placed in the form of suitable size, in which under pressure may be injected material filler 40. According to one aspect of this embodiment, the form may be provided with an internal chamber sized greater than the matrix 26, whereby the material of the filler 40 envelops the matrix 26. As described above, in the illustrated embodiment, the matrix 26, in which the spacers 28 are hollow, the passages 34 of the struts 28 remain inherently material-filler 40 after injection molding, as each of the passages 34 is closed at the end portions of the respective struts 28 and essentially separated from the interconnected macropores 30. In addition, in the above-described embodiment, where one or more sections of the device 10 may be provided with exposed areas of matrix 26, devoid of the material of the filler 40, it is assumed that the relevant parts of the matrix 26 can be filled with a removable material, such as polyethylene glycol, waxes, hydrogels or acrylic latexes, before the sur�USA the area or areas of matrix 26 is added to the material of the filler 40. Similarly, after the material-the filler 40 is added to the desired areas of matrix 26, the removed material may be removed by dissolving through one or more solvents and/or by heat treatment, along with other methods. In addition, although not described above, you need to understand that the matrix 26 and/or the material of the filler 40 can be processed for the purpose of education or improvement of border chemical bond between them. For example, in one embodiment, it is assumed that one or more polar functional groups, such as a simple ether group or ester group, can be added to the material of the filler 40. In another embodiment, it is assumed that the matrix 26 can first be washed with ammonium hydroxide or other solution that can change the polarity on its surface. In another embodiment, it is assumed that the material of the filler 40 may be added a surfactant or emulsifying agent. For example, according to one aspect of this variant it is assumed that the material of the filler 40 may be added oleic acid before it is introduced in one or more sections of the matrix 26.

Upon completion of the molding process, the matrix 26 and the material of the filler 40 provide a composite billet, essentially appropriate form� and size used in the injection molding process the form and is ready for further treatment to ensure the desired configuration of the device 10. For example, it is assumed that the composite billet may be machined to achieve the desired configuration of the device 10 through one or more processes, such as machining, cutting, laser molding, chemical cleavage, etching, stitching and serration, among other non-limiting examples.

When processing of the workpiece to obtain the final configuration of the device 10 areas of matrix 26 are exposed on the outer surface 14, in addition to areas of the material of the filler 40. In the illustrated embodiment where the spacers 28 of the matrix 26 contain passages 34, the end portions and/or additional areas for at least part of the spacers 28 are removed during the processing, thereby forming the openings 36, the opening corresponding to the passages 34, as shown in the photographic image of Fig.5, which shows an enlarged view of the sample area of the outer surface 14 of the device 10. In particular, a spacer 28 to provide an open area of the matrix 26 surrounding the hole 36 so that it is in fact separated from the material of the filler 40. Accordingly, the hole 36 provides an access point through which the bone and/or tissue may grow into the passage 34 of the respective struts 28. In addition, since all the passages 34 are interconnected, it is necessary to understand caprolactone bone and/or tissue in one pass 34 may be distributed in additional passages 34, even if such additional passages 34 are not open through holes 36 on the outer surface 14. You should also understand that depending on the amount of material removed from the end portion of the strut 28, the exposed areas of matrix 26 may contain a single opening 36, the opening corresponding to the passage 34. In addition, the openings 36 and, to some extent, the exposed areas of matrix 26 may usually be limited to areas of the device 10 subjected to additional processing at the end of the molding process, to obtain the device 10 the desired configuration of the composite billet formed from the matrix material 26 and filler 40. Similarly, it is envisaged that in one embodiment, the outer surface 14 of the device 10 may contain a plurality of holes 36 and/or exposed areas of matrix 26, while in another embodiment, the outer surface 14 may contain a small number of holes 36 and/or exposed areas of matrix 26, depending on the use of processing after molding process. Also, in some embodiments, where the spacers 28 are hollow and contain passages 34, 36 holes on the outer surface 14 will not. In addition, it is also assumed that areas of the workpiece that is processed after the process of injection molding a molded�I, can at least partially be determined or dependent on the choice of the anatomical location at which the implanted device 10.

In one or more embodiments, it is also assumed that the device 10 can also be used for delivery of the pharmacological agent. For example, in one embodiment in which the matrix 26 is made of a bioresorbable material, the pharmacological agent may be deposited on the outer surface of the plate 26 before macropores 30 fill material-filler 40. In this embodiment, the pharmacological agent may gradually bared in vivo as resorption of the matrix 26. However, in another embodiment it is assumed that the pharmacological agent may be contained in the passages 34, but there are other possible options to ensure the pharmacological agent. For example, in one alternative embodiment, it is assumed that the pharmacological agent may be mixed with the material of the filler 40 before the specified material will be introduced at least in part macropores 30 of matrix 26, and then the agent can be delivered in vivo material-filler 40 after implantation of the device 10. According to one aspect of this variant, the material of the filler 40 may be biodegradable or bioresorbable material such as a biodegradable or bioresorbable polymeric materials�ial, a therapeutic agent can gradually come out of the material of the filler 40 as the destruction or resorption.

In one alternative embodiment, it is assumed that the pharmacological agent may be applied to exposed areas of the material of the filler 40 after the specified material is embedded in at least a portion of macropores 30 of matrix 26, and then the agent can be delivered in vivo with the exposed surfaces of the material of the filler 40 after implantation of the device 10. According to one aspect of this variant form pores agent can be used in material-the filler 40, when the material introducing at least a portion of macropores 30 of matrix 26, to form one or more pores in the material-the filler 40, which accommodates a pharmaceutical agent. According to other aspects should be understood that the exposed areas of the material of the filler 40 may be subjected to chemical or mechanical treatment before they will cause a pharmaceutical agent, which helps to enhance the binding or adhesion between the pharmaceutical agent and the material of the filler 40. In addition or alternatively, the pharmaceutical agent may be chemically treated to enhance the bonding or adhesion between it and the material of the filler 40. Further, according to Dr.�shM aspects of this option assumes that what for attaching pharmaceutical agents to open areas of the material of the filler 40 may be used one or more types of bioresorbable adhesive means.

If you use a pharmaceutical agent, it may contain a growth factor that can increase the rate of accretion or provide some other beneficial effect. For delivery through the device 10 can be used in a wide range of growth factors. For example, the growth factor may include a bone morphogenetic protein, LIM-mineralization proteins, transforming growth factors such as transforming growth factor-beta, insulin-like growth factors, platelet derived growth factors, growth factors, fibroblasts, or any other similar growth factor, rendering any positive effect. If growth factors or other pharmacological agents are used, they are usually provided in therapeutically effective amounts. For example, growth factors may be included in amounts effective to stimulate fusion.

In one specific embodiment, the growth factor is a bone morphogenetic protein, including recombinant human bone morphogenetic proteins (rhBMP). For example, in one embodiment, the bone morphogenetic protein is a protein rhBMP-2, rhBP-4 or their heterodimer. However, it is anticipated using bone morphogenetic proteins, including bone morphogenetic proteins from BMP-1 to BMP-18. Bone morphogenetic proteins can be purchased from Genetics Institute, Inc., Cambridge, Mass. and can also be prepared as described in U.S. patent No. 5,187,076, Wozney et al.; U.S. patent No. 5,366,875, Wozney et al.; U.S. patent No. 4,877,864, Wang et al.; U.S. patent No. 5,108,922, Wang et al.; U.S. patent No. 5,116,738, Wang et al.; U.S. patent No. 5,013,649, Wang et al.; U.S. patent No. 5,106,748, Wozney et al. and patent PCT no WO 93/00432, Wozney et al.; WO 94/26893, Celeste et al. and WO 94/26892, Celeste et al. Can be used all bone morphogenetic proteins, obtained as described above, as separated from the bone. Methods for isolating bone morphogenetic protein from bone are described, for example, in U.S. patent No. 4,294,753, Urist; Urist et al., 81 PNAS 371, 1984.

In other embodiments, the pharmacological agent may be an agent used to treat a variety of spinal disorders, including infections of the spinal cord, cancer of the spinal cord and osteoporosis. Such agents include antibiotics, analgesics and anti-inflammatory drugs, including steroids, but other exemplary embodiments of the agents known to the specialist. These agents also are used in therapeutically effective doses, allowing to treat various�title of the disease and the resulting symptoms and these agents can be determined by a specialist depending on each individual case.

In another napsoluciones embodiment, the implant contains open areas osteoconductive or osteoinductive material, and a biologically stable material, on their external surfaces, and osteoconductive or osteoinductive material suspended or dispersed in a biologically stable material. In particular, in one case of this embodiment, the particles of the bioactive ceramic material, such as Skelite®, can be homogeneously mixed with the biologically stable material such as a biologically stable polymeric material, including, for example, representatives of a number of polyaryletherketones (PAEK) including polyetheretherketone (PEEK) reinforced with carbon fiber PEEK, and polyetherketoneketone (PEKK). A homogeneous mixture, through a process of injection molding, extrusion or compression molding, can be given to the configuration of the implant or blank from which may be obtained the desired configuration of the implant by further processing in any way, including (but not limited to) machining, cutting, laser molding, chemical cleavage, etching, stitching and cutting. Exposed osteoconductive or osteoinductive�tion material may generally contribute to the increase in the rate of accretion and provide early fixation of the implant by attaching to the bone while biologically stable material continues to provide the mechanical properties required in the anatomical location where the implant is used.

In another embodiment, implantable medical device includes a housing having an outer surface forming the outer profile of the device. The outer surface includes one or more open areas of the porous matrix containing a group of interconnected macropores and biologically stable material filler, essentially filling at least a portion of the interconnected macropores. After implantation of the porous matrix undergoes a process of remodeling, during which the activity of osteoclasts leads to a gradual destruction of sections of the porous matrix and osteoblast activity leads to a gradual replacement remote sites of the porous matrix of newly formed bone tissue. According to one or more aspects of this embodiment, the initiation of the remodeling process limited to one or more open areas of the porous matrix on the outer surface of the device. According to another aspect of this embodiment of a porous matrix made of a material Skelite®, and have a biostable material selected from the group comprising polyetheretherketone (PEEK), reinforced plevyak�Ohm PEEK and polyetherketoneketone (PEKK).

In another embodiment, the implant contains a ceramic matrix, provided with openings that are completely or partially filled with a biologically stable material-filler. The implant also includes an external surface, which wraps around its outer profile. In one embodiment of this embodiment, the outer surface around the entire outer profile of the device formed by the open areas of the porous matrix and biologically stable material-filler. In other words, the outer surface is formed by the discontinuous configuration of alternating sections of the matrix and biologically stable material filler. In another embodiment of this embodiment, a ceramic matrix made of a material Skelite®, and have a biostable material selected from the group comprising polyetheretherketone (PEEK) reinforced with carbon fiber PEEK, and polyetherketoneketone (PEKK), but also looks at alternative options for the materials of the ceramic matrix and the material is filler.

In another embodiment, the provided methods of stabilization and stimulation of coalescence of adjacent bones or portions of bones along the carrier axis. For example, in one embodiment of this variant implementation, the method includes providing an implant, preferably carrying the load of the implant, such ka� above-described device 10, and preparing adjacent vertebrae for placement of the implant in the disk space between adjacent vertebrae. Such methods of preparation are well known to the specialist, and may include the removal our entire intervertebral disc or portion thereof, including any of the fibrous ring or nucleus pulposus, or parts of them. Then the implant may be placed in the disk space between adjacent vertebrae, after the stage of preparation.

Examples

The following examples are described solely for illustrative purposes and should not be construed as limiting the invention, as disclosed herein, embodiments of disclosed in these examples.

Example 1

Composite billet containing a porous matrix made of a bioresorbable ceramic material and have a biostable polymeric material, of which there can be obtained an implant, such as the device 10 was prepared as follows.

As an initial mesh template was used polyurethane foam cylindrical shape with a diameter of 25 mm and a length of 25 mm. Were provided with two liquid ceramic slurry using the material Skelite® provided by the company Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. One suspension had a solids content of 25 vol.%, and the other 17%. Both suspense�and were subjected to grinding in a ball mill for 5 hours. The foam material was immersed in a suspension with a solids content of 25 vol.% and stirred to remove air with the purpose essentially to fill the pockets of the suspension and to cover her struts of the foam. Obtained the saturated foam was removed from the suspension and placed on a sieve attached to a vertically static vacuum hose. Excess slurry was removed from the pockets by the inclusion of a vacuum unit for 3-5 seconds. The specified time was sufficient to remove excess slurry from the pockets of the foam without breaking the suspension is attached to the struts of the foam. Covered the foam was dried in an oven at 120 ºC for 15 minutes. The whole process is repeated 1-2 more times for slurry with solids content of 25 vol.% and another 4-10 times for slurry with solids content of 17 vol.%.

Dried and coated foam substrate was moved in an electric oven where it was heated at a speed of 1 º C/min to a temperature in 500º order to remove the water and reach the pyrolysis of polyurethane foam, while not breaking the porous ceramic matrix. The foam was maintained at a temperature of 500º for 4 hours, and then heated at a speed of 1 º C/min to a temperature in 1500º. The specified temperature is maintained for 2 hours to allow the ceramic particles are sintered, thereby providing a porous ceramic matrix with open cells having a Phi�quarter morphology of the starting material of the polyurethane foam. Then furnace cooled at a rate of approximately 36 ° C/min to the final temperature of 25ºC. The final dimensions of the porous ceramic matrix was approximately 20 mm in diameter and about 20 mm in length, and the density was about 2.9 g/cm3.

Apparatus for injection molding PEEK was configured so that the molding cavity was sized to accommodate the porous ceramic matrix. Transmissive mechanism of the mold cavity was chosen in such a way as to ensure a homogeneous and uniform filling of the cavity of the porous ceramic matrix. Mold temperature was set in the range of about 120-200 ° C, and the temperature of the drum was set in the range of about 350-380º. The pellets were then PEEK loaded into the charging port of the device for injection moulding, from where they were applied as needed by the auger through the heater and into the mold cavity through the sprue. Used material PEEK was a Victrex® PEEK 150G, high-performance unreinforced semi-crystalline thermoplastic, provided by Victrex USA, Inc., 300 Conshohocken State Road, Suite 120, West Conshohocken, PA 19428.

Porous ceramic matrix was loaded into the mold cavity when the form of the apparatus for injection molding was open. Porous ceramic matrix or directly loaded into the mold cavity, either pre - �Agrawal frame to a temperature of about 230º before placing in the form, as pre-heating reduces the PEEK cooling in contact with a porous ceramic matrix. The geometric shape of the porous ceramic matrix was such that the external profile is essentially filled the mold cavity. The form of the apparatus for injection moulding is then closed, thus placing the porous ceramic matrix within the mold cavity.

To fill the open spaces of the porous ceramic matrix material PEEK material PEEK filed into the mold cavity under pressure molding in the 1100 psi (7584 kPa) during the time of filling, approximately 7 minutes. Penetration PEEK through porous ceramic matrix during casting contributed to maintaining the high temperature form for the purpose of reducing the viscosity PEEK at the casting (this was achieved by means of a hot oil Thermolator production Budzar Industries, 38241 Willoughby Parkway, Willoughby, OH, 44094); the use of the Central sprue, a guide PEEK in the center of the porous ceramic matrix; if the porous ceramic matrix contain a hollow core, used the guide unit of flow inside the hollow core to direct the flow PEEK radially for the purpose of homogeneous filling of the porous ceramic matrix; and pre-heating the porous ceramic matrix prior to the introduction into the cavity for the purpose �sejati local cooling PEEK at its contact with the relatively cold porous ceramic matrix, thereby maintaining a lower viscosity PEEK when casting.

The injection molding apparatus automatically extracted composite porous ceramic preform matrix/PEEK from the cavity when opened via a standard extraction of cores for injection molding. The composite billet was published in a collection chamber located below the apparatus, to retrieve the operator and then can be processed to shape using processing methods implants, avoiding chemical contamination, such as coolers.

Any theory, mechanism of operation, proof, or conclusion given in the present description, are intended to further facilitate understanding of the present application and are not intended to assert the dependence of this application from any such theory, mechanism of operation, proof, or finding. You need to understand that despite the fact that the use of the terms "preferred" and "preferably" in the above description indicates that the described thus the feature may be most desirable, it nonetheless may not be required, and embodiments of, deprived of it, may be deemed to be included in the scope of the invention defined by the following claims. When reading the formulas you need to understand that in the case of using such baths�new, as "at least one", "at least part", the formula is not intended to limit the paragraph to only one element, except when the opposite is stated openly. In addition, in the case of the use of the terms "at least a portion" and/or "part" element may contain parts and/or the entire element, except for the cases when the opposite is stated openly. Despite the fact that the application illustrated and described in detail in the drawings and in this description, these funds should be considered as illustrative and not limiting in nature, and meant that there were shows and describes only selected embodiments of and that all changes, modifications and equivalents that are within the scope of the invention as defined in the application or in any of the following claims, should be protected by law.

1. Implantable medical device (10) for stabilization and stimulation of bone remodeling and/or tissue in the adjacent bones or bony tissues containing body (12) with the outer surface (14) forming the external profile of said device (10), where the specified body contains:
porous matrix (26) containing a group of interconnected macropores (30) formed by interconnected struts (28), each of which has an inner cavity, and
material-filler (40) substantially filling at least part of the specified group of interconnected macropores (30), in this case,
the internal cavity of these interconnected struts (28) are connected with each other, thus forming a hollow matrix of passageways (34) passing through the spacers (28),
and a few holes (36) passing at least through the specified area of the outer surface (14) and communicating with said internal cavity at least a portion of said interconnected struts (28) make available to the hollow matrix of passageways (34) and provide an access point through which the bone and/or tissue may grow into the passage (34) of the strut (28), while the germination of bone and/or tissue in one pass (34) may be distributed in additional passes (34), since all the passages (34) interconnected,
in which the porous matrix (26) comprises a ceramic material, and the material of the filler (40) comprises a polymer material, wherein the ceramic material is bioresorbable, polymeric material is biologically stable, the ceramic material includes ceramics based on calcium, and a polymeric material selected from the group consisting of polyetheretherketone (PEEK), glass-fibre reinforced PEEK, and polyetherketoneketone (PEKK).

2. The device (10) according to claim 1, wherein the inner cavity is separated from the specified group of interconnected macropores (30).

3. The device (10) �about p. 1, in which the internal cavity of these interconnected struts (28) essentially does not contain the specified material filler (40).

4. The device (10) according to claim 1, wherein said area of the outer surface (14) formed by a specified multiple holes (36), open areas specified porous matrix (26) and open areas of said material filler (40).

5. The device (10) according to claim 4, wherein said area of the outer surface (14) passes around a specific exterior profile of said device (10).

6. The device (10) according to claim 4, wherein the one or more specified open areas specified porous matrix (26) is surrounded by one or more specified multiple holes (36) and separating the said hole (36) of the specified neighboring open area of said material filler (40).

7. The device (10) according to claim 1, in which ceramics based on calcium selected from the group including ceramics based on calcium sulphate, calcium carbonate and calcium phosphate.

8. The device (10) according to claim 7, in which:
ceramics based on calcium formed by a compound containing calcium, oxygen and phosphorous; and
a portion of at least one of the specified elements are replaced by an element having an ionic radius in the range of from about 0.1 to about 0.6 Å.

9. The device (10) according to claim 8, in which the specified soedineniya formula
(Ca)i{(P1-x-y-zBxCyDz)Oj}2:
where b, C and D is selected from elements having an ionic radius of approximately 0.1 to 0.4 Å;
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 or equal to 2 but less than or equal to 4; and
j equals 4-δ, where δ is greater than or equal to zero and less than or equal to 1.

10. The device (10) according to claim 1, wherein the material of the filler (40) essentially fills every macropore from a specified group of interconnected macropores (30).

11. The device (10) according to claim 1, wherein said body (12) configured for placement between adjacent bones or bony tissues, and the specified external surface (14) comprises a located opposite each other of the upper and lower parts (18, 20) with a multitude of projections (24) formed for engagement with said adjacent bones or bony tissues.

12. The device (10) according to claim 1, which mescalinum device-an implant for facilitating fusion of adjacent vertebral bodies.



 

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7 cl, 2 dwg, 16 ex

FIELD: medicine.

SUBSTANCE: there are described new reinforced biodegradable frames for soft tissue regeneration; there are also described methods for living tissue support, extension and regeneration, wherein the reinforced biodegradable frame is applied for relieving the symptoms requiring high durability and stability apart from patient's soft tissue regeneration. What is described is using the frames together with cells or tissue explants for soft tissue regeneration in treating medical prolapsed, e.g. rectal or pelvic prolapse, or hernia.

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14 cl, 19 dwg, 2 tbl, 8 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine and tissue engineering, and may be used in cardiovascular surgery for small-vessel bypasses. A vascular graft is made by two-phase electrospinning with the staged introduction of the ingredients into the polymer composition.

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2 cl, 1 ex

FIELD: medicine.

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2 ex

FIELD: medicine.

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2 cl, 1 ex

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17 cl, 7 dwg, 1 ex

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EFFECT: obtained matrices are free-shaped yet pertain stability and hardness characteristics required to withstand surgical implantation methods and counteract mechanical forces applied at the implantation point.

40 cl, 2 tbl, 8 ex

FIELD: medicine.

SUBSTANCE: present group of inventions concerns medicine, more specifically coated implants and devices. There is offered ceramic composition-precursor for making high-strength bio-elements used as an absorbable or partially absorbable biomaterial where the composition contains at least one silicate with Ca as a base cation with the absorption rate less or equal to the bone growth rate, and this at least one silicate acts as a base binding phase in a biomaterial, and this at least one silicate Ca is present in amount 50 wt % or more, and all other components if any are presented by additives, such as an inert phase, and/or additives which make a biomaterial to be radiopaque. There is offered hardened ceramic material which is based on the ceramic composition-precursor and is in the hydrated form. There is offered a medical implant, application of the medical implant, and also a device or a substrate coated with the uncured ceramic composition-precursor and/or hardened ceramic material.

EFFECT: invention provides a biomaterial having initial and constant durability which is dissolved in due time and reacts with an organism to generate a new tissue.

29 cl, 1 ex, 3 tbl

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine. Claimed is composition with hyaluronic acid (HA), which includes gel particles of bound water-insoluble hydrated HA. HA includes bindings, represented with the following structural formula: HK'-U-R2-U-TK'. Where each group HA' represents the same or other molecule of bound HA'; each U independently represents optionally substituted 0-acylisourea or N-acylurea; and R2 represents optionally substituted alkyl, alkenyl, alkinyl, alkoxy, cycloalkyl, cycloalkenyl, cycloalkinyl, aryl, heteroaryl, heterocyclic radical, cycloaliphatic alkyl, aralkyl, heteroaralkyl or heterocyclolalkyl. Also claimed is method of developing tissues in individual, including introduction of needle into individual in place where development of tissues is necessary, needle is connected to syringe filled with composition with HA, and applying force to syringe in order to supply composition with HA to individual. Method of obtaining composition with HA includes formation of water-insoluble dehydrated particles of bound HA, separating insoluble in water particles by their average diameter, selection of subset of particles by average diameter and hydration of subset of dehydrated particles by means of physiologically compatible water solution. Other method of obtaining composition with bound HA includes binding precursor of bound HA by means of bis-carbodiimide in presence of pH buffer and dehydration of bound HA. Also included is method of developing tissues in individual that needs tissue development. Method of stabilisation of bound HA includes hydration of water-insoluble dehydrated bound HA by means of physiologically compatible water solution which includes local anesthetic, so that value of elasticity module G' for stabilised composition constitutes not less than approximately 110% from value G' for non-stabilised composition.

EFFECT: claimed composition of hyaluronic acid and method of preparation and application of HA composition are efficient for development of tissue and/or drug delivery.

27 cl, 22 ex, 2 tbl, 7 dwg

FIELD: chemistry.

SUBSTANCE: effect is achieved by using compositions based on different stereoregular amorphous biodegradable polymers - polylactides and copolymers of lactides with glycolides (18-72 mass ratio) as the second component of biocompatible mineral filler - hydroxyapatite with particle size of the main fraction of 1-12 mcm (8-41 mass ratio), as well as an organic solvent with boiling temperature equal to or higher than softening temperature by 3-20°C (20-41 mass ratio). After preparation of a homogenous mixture, the composition is undergoes thermal treatment at 80-130°C in a vacuum in a shaping vessel with the required shape. A porous product is obtained due to removal of solvent. Density of the obtained porous product is about 0.4-0.8 g/cm3.

EFFECT: design of a method of obtaining porous biodegradable composite polymer products based on polylactides or copolymers of lactides and gylcolides.

3 cl, 3 ex

FIELD: medicine.

SUBSTANCE: there are described new reinforced biodegradable frames for soft tissue regeneration; there are also described methods for living tissue support, extension and regeneration, wherein the reinforced biodegradable frame is applied for relieving the symptoms requiring high durability and stability apart from patient's soft tissue regeneration. What is described is using the frames together with cells or tissue explants for soft tissue regeneration in treating medical prolapsed, e.g. rectal or pelvic prolapse, or hernia.

EFFECT: frames are adequately durable to be applicable for implantation accompanying the medical conditions requiring the structural support of the injured tissues.

14 cl, 19 dwg, 2 tbl, 8 ex

FIELD: medicine.

SUBSTANCE: invention can be used in the surgical management of non-inflammatory maxillary sinus diseases (MSD). An endonasal opening and sanitation of the maxillary sinus are performed. A plate of a synthetic polymer, porous polytetrafluoroethylene (ePTFE) 1 mm thick and with an open porosity of 70% is used to model a transplant of an adequate shape and by 5% more than the area of a bone postoperative defect of a posterior wall of the maxillary sinus. The transplant is laid on the residual anterior bone wall of the maxillary sinus. The soft tissues are closed completely rigidly fixing the transplant to the bone.

EFFECT: method enables preventing early postoperative complications related to an in-growth of the cicatrical tissue into the sinus lumen by forming a fibrous frame of the connective tissue closing the postoperative defect.

1 ex

FIELD: medicine.

SUBSTANCE: bioactive porous 3D-matrix for tissue engineering involves a resorbed partially crystalline polymer having a porosity of 60-80% and a pore size of 2 to 100 mcm. A biopolymer gel having a particle size of 30-100 mcm is incorporated into a portion of the pores. A polymer/gel ratio makes 99:1 to 50:50 wt %. The matrix is prepared by grinding a mixture of gel and polymer powder having an average particle size of 100 mcm, and the prepared mixture fills prepared moulds to be placed in a high-pressure chamber wherein the temperature is increased to 25-40°C first, and then the CO2 pressure is increased to 4.0-25.0 MPa. The system is kept in the above environment for 1 hour, and then the chamber pressure is discharged to an atmospheric one for 30-120 minutes; thereafter the temperature is decreased to a room value, and the patterns are removed.

EFFECT: ensuring flexibility of using the matrix in various organs and systems, no toxicity, higher ability to tissue regeneration stimulation, prolonged effect of biostimulation.

6 cl, 5 ex, 1 tbl, 4 dwg

FIELD: medicine.

SUBSTANCE: tissue regeneration or healing is stimulated when using a structure comprising a multilayer plate of a collagen membrane material, which contains a lamellated barrier material of pure collagen prepared of a natural collagen tissue; the lamellated barrier material containing a barrier layer with an outer smooth barrier surface and a fibre surface, which is opposite the outer smooth barrier surface. The structure additionally contains a matrix layer of a collagen sponge material adjoining the fibre surface.

EFFECT: matrix layer of the collagen sponge material is absorbed by an individual's body at a higher rate, than the lamellated barrier material.

20 cl, 3 dwg, 5 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine. There are described methods for making implantable medical devices, preferentially of PEEK, having antimicrobial properties. The antimicrobial action is ensured by implantation of ceramic particles containing antimicrobial metal cations into the molten PEEK resin to be cooled and finally shaped by injection moulding, cutting and mechanical treatment or by other processing methods.

EFFECT: implants possess effective antimicrobial action for reducing a bacterial growth and a risk of infection.

12 cl, 1 dwg, 3 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for preparing a cell-free organic tissue of a human or animal origin for the vitality recovery, particularly for introducing living cells, involving a stage of making a number of holes (4; 14) in the cell-free organic tissue (2; 12) through its surface (8; 18) and setting in the tissue (2; 12); wherein the said number of holes (4; 14) is formed using a needle or a kit of needles. The holes (4; 14) are partially intersected thereby forming partially connected holes (4; 14).

EFFECT: invention also refers to a respective cell-free organic tissue (2; 12) of the human or animal origin.

17 cl, 3 dwg

FIELD: process engineering.

SUBSTANCE: invention relates to medicine. Proposed method can be used in stomatology and orthopedics for production of medical materials stimulating recovery of bone tissue defects, for making dental stopping and dental pastes. It comprises preparation of mix containing compounds of calcium, phosphorus, silicon and sodium, impregnation of bioinertial incombustible porous matrix with made mix, matrix is composed of ceramics from aluminium or zirconium oxides followed by calcination. Note here that silicon compound represents tetraethoxysilane. Note also that phosphoric acid ether is used as phosphorus compound. Calcium and sodium compounds are represented by their carboxylates in polar organic solvent. This method includes making the thin layers on more strong bioinertial porous ceramics. Note also that said process involves no special complicated equipment and expensive reagents.

EFFECT: production of glass ceramics directly from solution omitting sol preparation stage, simplified and accelerated process.

7 cl, 5 ex

FIELD: medicine.

SUBSTANCE: invention refers to porous microsphere granules with the adjusted particle size for bone tissue regeneration. The above microspheres have a size within the range of 1-1000 mcm, have through pores of the size of 1-100 mcm and total porosity 40-75%. The declared microsphere granules are prepared by granulation by electrospinning, and heat-treated. A mixture used to form the granules by electrospinning contains a mixture of magnesium orthophosphate and biological hydroxyapatite of bovine demineralised bones in ratio 0.5:1.0, as well as 1-3% sodium alginate in distilled water and a hardener representing saturated calcium chloride.

EFFECT: invention provides preparing the microsphere granules possessing biocompatibility, biodegradation, osteoinduction and osteoconduction properties and able to be substituted by the bone tissue.

2 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to ophthalmosurgery, and in particular to scleroplasty. Transplant for scleroplasty has polymeric base, covered with porous layer of the same polymer. As polymer base, transplant includes layer, made from porous stretched polytetrafluoroethylene, which has nodular-fibrillar structure. As porous layer, it includes layer of porous polytetrafluoroethylene, which has volume fraction of void space 15-40%, specific surface of void space 0.25-0.55 mcm2/mcm3, average distance between voids in volume 25-30 mcm and average chord volume 8-25 mcm, with the total width of transplant constituting 0.15-0.35 mm (first version). Transplant for scleroplasty can also include porous layer of polymer, whose surface is processed to add compatibility with sclera tissue. Transplant surface is processed by application of allogenic dermal fibroblasts of 3-5 passages of culturing, with the total width of transplant being 0.15-0.35 mm (second version).

EFFECT: chemically and biologically inert transplant, which ensures effect of invasion of sclera tissues, is obtained.

2 cl

FIELD: medicine.

SUBSTANCE: invention relates to chemical-pharmaceutical industry and represents artificial dura mater, produced from electrospinning layers by technology of electorspinning, with electrospinning layer, consisting of, at least, hydrophobic electrospining layer, which is produced from one or several hydrophobic polymers, selected from polylatic acid and polycaprolactone.

EFFECT: invention ensures creation of artificial dura mater, which has good tissue compatibility, anti-adhesiveness and possibility of introducing medications, preventing cerebrospinal fluid outflow during regeneration of person's own dura mater.

30 cl, 7 ex, 11 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a two-phase bone filler material of calcium phosphate / hydroxyapatite (CAP/HAP) containing a sintered CAP nucleus and at least one uniform and closed epitaxial growing layer of nanocrystalline HAP coating the sintered CAP nucleus from above; the epitaxial growing nanocrystals have a size and a morphology identical to a human bone mineral, i.e. the length of 30 to 46 nm and the width of 14 to 22 nm. What is described is a method for preparing the bone filler material of CAP/HAP involving the stages as follows: a) making the sintered CAP nucleus, b) immersing the sintered CAP nucleus into an aqueous solution at 10°C to 50°C to initiate the process of CAP to HAP transformation to form the uniform and closed epitaxial growing nanocrystalline hydroxyapatite on the surface of the sintered CAP nucleus with the epitaxial growing nanocrystals have the size and morphology identical to the human bone mineral, c) terminating the transformation by separating the solid material from the aqueous solution in the presence of the uniform and closed coating of at least one HAP nanocrystalline layer, until the comprehensive completion of the transfomraiton process, d) optionally sterilising the material separated at the stage c), and using the above bone filler material as an implant or a prosthesis for osteogenesis, bone regeneration, bone repair and/or replantation at the site of injury in a human or animal.

EFFECT: preparing method for preparing bone filler material of CAP/HAP.

15 cl, 3 tbl, 6 ex

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