• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Prosthesis for at least a portion of a bone, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, wherein the prosthesis is made of a metal or an alloy thereof and is provided with at least one in the area of the prosthesis facing outward surface after placement in the body, which area is formed by a layer provided with interconnected open spaces, the open spaces being dimensioned for allowing growth of bone tissue therein
    公开号:NL2020651A
    申请号:NL2020651
    申请日:2018-03-23
    公开日:2018-09-28
    发明作者:Yves Mommaerts Maurice
    申请人:Cadskills Bvba；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION
    The invention relates to a prosthesis for at least a portion of a bone of a body, in particular a human body, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state.
    When a (part of) a bone that may or may not be part of a joint has to be replaced by a prosthesis, that bone will also have to be detached if the bone part in question also forms a point of attachment for a tendon of a muscle. After placement of the prosthesis, there will be too little possibility for anchoring the tendon. After all, a large part of the bone is then replaced by the prosthesis where a tendon cannot attach itself biologically. Often prostheses are made from metals such as titanium or alloys thereof.
    Under certain circumstances it may be possible to fix the affected tendon in a different place on bone, but this has the disadvantage that the force play differs from the natural one.
    Often, it is therefore not necessary to re-attach the tendon, thereby loosing the muscle in question. Rarely can another muscle take over the function, and then only partially. This can be a major problem for the patient.
    An example is the lower jaw when on one side thereof the condylar head of a temporomandibular joint has to be replaced by a prosthesis. The condylar head forms the site of attachment for the lower branch of the pterygoideus lateralis muscle, which muscle provides for opening the mouth and for moving the discicular articularis in the ventral direction. The one-sided or two-sided unavailability of this muscle function can give the patient great difficulties in chewing and talking. Furthermore, the absence of muscle function in the face may be visible to others, because the chin skews when the mouth is opened.
    SUMMARY OF THE INVENTION
    It is an object of the invention to provide a bone prosthesis with which, after placement in the body, the effect of a muscle originally associated with the replaced bone (part) can be maintained.
    From one aspect, the invention provides a prosthesis for at least a portion of a bone of a body, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, the prosthesis being made of a metal or an alloy thereof and provided with at least one area of the surface of the prosthesis, which is disposed after placement in the body, and which is formed by a layer of material provided with open spaces connected to one another.
    The tendon can be placed on the porous surface thus provided, in engagement with it. The interconnected spaces, pores, layer, which is located on the (outer) surface of the prosthesis, forms a bed in which bone tissue can develop. Connective tissue fibers from the tendon can grow into that bone tissue.
    The interconnected spaces form an open structure which, when filled with the bone tissue, gives an anchoring effect, in particular due to the fact that the material of the said area extends over many open spaces. Thus, an attachment possibility is provided for tendon tissue, which would otherwise not be able to adhere to the prosthesis, in particular because of the material chosen. As a result, the relevant muscle effect does not have to be lost.
    Also, if a bone piece or bone fragment has been left attached to the loosened tendon, that bone fragment may adhere to the newly formed bone tissue in the prosthetic pores through bone healing.
    Said porous surface area is located on the prosthesis at a location corresponding to the location of the muscle's tendon on the bone for which the prosthesis is the replacement.
    The porous region is local, and is surrounded on the outer surface of the prosthesis by pore-less surfaces, in particular smooth surfaces, from the outer surface of the prosthesis.
    In an embodiment which has a high degree of porosity, the layer is formed by ribs, rods or bars of the material of said layer, with the occurrence of a spatial skeleton or three-dimensional lattice, the spaces between the ribs, bars or bars to be open.
    In an alternative embodiment, the open spaces are formed by a tangle of short channels in open communication, each bounded by the material of the layer. The channels can extend in different directions. The channels may extend in a direction with a directional component parallel to the interface on the nearest outer surface of said area.
    The structure defining the open spaces, in particular the grid, can be regular.
    The size of the cross-section of open spaces, pores, open cells can be in the range of 0.25 mm - 1.0 mm, more in particular in the range of 0.35 mm and 1.0 mm, more in in particular between more than 0.41 mm and 1.0 mm.
    In order to promote the development of bone tissue, the open spaces may have a diameter in the range of 0.45 mm - 0.55 mm. The open spaces can have a mutually at least substantially the same cross-section.
    The anchoring of the tendon via the bone tissue is promoted if the layer provided with open spaces is at least about 0.5 mm thick, preferably a few mm thick.
    The layer provided with open spaces can have a porosity in the range of about 50% - about 95%.
    The area of the layer with open spaces can have such a size and shape in the surface of the prosthesis that it may be entirely covered by the tendon.
    In case multiple muscles have been connected to the replaced bone (portion), multiple areas may be present on the prosthesis surrounded by surfaces without pores, in particular smooth surfaces. A potential attachment area is then available for each tendon.
    Said layer can be made of the same material as the adjacent areas of the prosthesis. The prosthesis can be made as a whole. Alternatively, the prosthesis can be manufactured in several parts, which are fixed to each other.
    Said layer, optionally the entire prosthesis, can be manufactured by means of a process of additive production technique, such as stereolithography, FDM, SLM, SLS or another 3D printing technique. With this, any desired open structure, regular or irregular, can be manufactured.
    Said layer, optionally the entire prosthesis, can be made of titanium or an alloy thereof. For the development of bone tissue, the presence of titanium oxide on the surface of the layer material, such as on the ribs, can be beneficial. That may have been formed there by exposure of titanium to air. Another bone growth stimulating coating, such as a form of calcium phosphate, can be applied with a suitable application technique.
    The prosthesis may be provided in or in the vicinity of said area with a receiving space for a suture, loop, hook, clamp or other device for at least initially fixing the tendon in engagement with said area. This may be, for example, a tunnel extending through the prosthesis, or a groove running around the prosthesis. The tunnel or groove can receive a suture to be used for the tendon. The function of the suture or other added (temporary) fastener can be canceled if the tendon has sufficiently adhered to the bone tissue.
    The prosthesis itself can, for example, be attached to the natural (healthy) bone by means of bone screws, and provided with holes for bone screws for this purpose.
    In order to speed up the binding process of the tendon, the formation of bone tissue in the open spaces, pores, open cells, can be promoted by applying a growth factor promoting the production of bone tissue. That growth factor can be a protein selected from the group consisting of PDGF, IGF, TGF-β, BMP, FGF, VEGF and PRP. Stem cells can also be placed in the open spaces or be admitted, or autologous / heterologous bone grafts can be applied.
    The invention can be used in one embodiment as a prosthesis for the mandibular side of a temporomandibular joint. In particular, such a prosthesis may comprise a head part for replacing the condylar head as well as a mounting plate for fixing the prosthesis on the rising branch of the lower jaw, and a condylar neck connecting these two interconnected necks, the condylar neck being provided with one or more of the aforementioned areas. This area can be such that it is suitable for attaching the tendon of at least one branch of the pterygoidus lateralis muscle, preferably for both branches of that muscle. To that end, the aforementioned area may be provided on the anterior-medial side of the condylar neck.
    For the above-mentioned temporary fixing of the tendon, the prosthesis may be provided with a groove or a passage for a suture, in particular in the condylar neck.
    Other applications are possible, in particular with other joints.
    From a further aspect, the invention provides a method for inserting a prosthesis for at least a portion of a bone, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, the prosthesis being made of a metal or an alloy thereof and provided with at least one porous area located in the surface of the prosthesis which, after placement in the body, faces outwards and which is formed by a layer of material provided with open spaces connected to one another the next steps:
    a-detaching from the bone area to be replaced one or more tendons, with or without their original enthese in a bone fragment, and removing the bone area to be replaced;
    b-positioning the prosthesis at the desired location to replace said bone area;
    c-at least temporarily capturing the tendons, with or without their original enthese, in a bone fragment, on the prosthesis, in engagement with the porous areas; and d-promoting bone tissue formation in said region within the layer, and allowing connective fibers of the tendon to grow into bone tissue formed in the pores of said prosthetic region or allowing bone healing to adhere to bone the bone fragment on the bone tissue formed in the pores in said region of the prosthesis.
    In one embodiment, before step b), the open spaces are provided with a growth factor promoting the production of bone tissue.
    In one embodiment, before step b), stem cells are introduced into the open spaces.
    In another embodiment, stem cells are admitted after step c, particularly in a natural post-surgery process.
    In an embodiment in which the aforementioned prosthesis is placed in front of the condylar head, the at least one branch of the pterygoidus lateralis muscle, with or without original enthusiasm with bone fragment, is detached from the bone area to be replaced, and in step c) the relevant branch of the pterygoidus lateralis muscle, with or without original enthese with bone fragment, is recorded on the prosthesis, on the porous area on the antero-medial side of the condylar neck. In one embodiment, steps a) and c) are performed for the lower branch of the pterygoidus lateralis muscle.
    From a further aspect, the invention provides a method for preparing the insertion of a bone prosthesis into a body to replace a portion of a bone to which a tendon is attached, comprising the following steps:
    a-determining (location, size, shape), such as by scanning, the bone portion to be replaced by the prosthesis and determining the place of attachment / enthusiasm of the tendon;
    b-designing the prosthesis on the basis of the outcome of step a, with a discrete porous area emerging into the surface of the prosthesis, corresponding to the place of attachment / enthesis of the tendon determined in step a;
    c-manufacturing the prosthesis in accordance with the design made in step b.
    The prosthesis can be manufactured in accordance with one or more of the above-described embodiments of the prosthesis according to the invention.
    The aspects and measures described in this description and claims of the application and / or shown in the drawings of this application can, where possible, also be applied separately from each other. These individual aspects can be the subject of split-off patent applications that are aimed at this. This applies in particular to the measures and aspects that are described per se in the subclaims.
    BRIEF DESCRIPTION OF THE DRAWINGS
    The invention will be elucidated on the basis of a number of exemplary embodiments shown in the accompanying drawings. Shown is:
    Figures 1A and 1B a first exemplary embodiment of a prosthesis according to the invention;
    Figures 2A-D show a second first exemplary embodiment of a prosthesis according to the invention;
    Figure 3 shows a schematic cross-section according to arrow 3 in figures 2A-D; and
    Figure 4 shows a schematic representation of a prosthesis according to figures 2A-D in a position placed on a lower jaw.
    DETAILED DESCRIPTION OF THE DRAWINGS
    Figures 1A and 1B show the mandibular component 1 of a temporomandular joint prosthesis (TMG prosthesis), which comprises a lateral wing 3 and a medial wing 4, which are connected to each other by an integral upper portion or comb 5, so that a type of saddle shape. The lateral wing 3 is provided with bone screw holes 6. An artificial jaw head 2 protrudes upwards via a neck 8 as a kind of saddle button at the rear end. As can be seen in figure 1A, a downwardly extending pin 7 is provided within the component 1 at the rear end, which pin remains at a distance from both wings 3 and 4. This pin 7 is optional and can be provided as intramedullary pin.
    Provided in the neck 8 is a hole 9 which extends from the lateral side to the medial side, suitable for passage of a surgical suture.
    The mandibular component 1 is designed and manufactured in alignment with the shape and condition of the rising branch of the lower jaw of the patient in question, such that both wings fit flush with the rising branch of the upper jaw, the artificial jaw head 2 replacing the condylar head, and the upper part 5 fits flush against the upper edge of the semisunaris incisura.
    Further, in the area of the neck 8, an area 10 is provided in the outer surface thereof, which, in deviation from the adjacent smooth surface areas, forms a porous surface 12. This area 10 is located on the antero-medial side of the condylar neck 8 and has a surface that is adjusted in size and shape to the dimensions of the portion of the tendon of the muscle in question to be attached thereto. The area 10 can have a thickness of, for example, 1 mm and forms the porous surface of a layer of material with an open structure. The size of the cross-sections of the open spaces in the porous area in this example is 0.45 to 0.55 mm.
    Figures 2A-D show an alternative, simpler embodiment of the mandibular component 1 of a temporomandular joint prosthesis (TMG prosthesis), from four different sides. The component 1 now comprises a lateral wing 3, a shoulder 5 and a condylar head 2, which are connected to each other by a condylar neck 8. Around the neck 8 there is a groove 9 for a suture thread. Also present in this example on the antero-medial side of the condylar neck 8 is an area 10 which, in deviation from the adjacent smooth-surface areas, forms a porous surface.
    Screw holes in the wing 3 have been omitted here.
    In this example, the mandibular component 1 is made as a whole from titanium, by means of a 3D printing technique, in alignment with the patient concerned.
    Figure 3 shows a very schematic section of an area 10, with adjacent solid areas of the prosthesis. The area 10, which offers a porous surface 12 with openings 11, is formed by a layer 13 which is composed of a regular system of rods 14 and has an open structure. The rods 14 form a spatial skeleton, also referred to as a scaffold, with open spaces or pores 15 connected to one another and to the openings 11. The rods 14 can define passages which each have a smallest diameter of approximately 0.5 mm. The thickness of the area 10 is here 2 mm. The area 10 is, together with the prosthesis made of titanium, with the aforementioned 3D printing technique. In the course of time titanium oxide will be formed on the surface of the rods 14 under the influence of air. The surface adjacent to the porous region 10 is smooth in this example.
    Prior to the operation of placing the mandibular component and the associated fossa component (not shown), stem cells and / or growth factors are introduced into the open spaces 15, in this case on the rods
    14.
    During the operation in / on the body of a patient, see also figure 4, after access to the operating area is obtained, the two branches of the pterygoid lateral muscle are detached from the natural, diseased condylar head, to be replaced. These muscles remain attached with their other end to the infratemporal surface and top of the large wing of the wedge bone (for the upper branch) and the lateral surface of the lateral pterygoid plate (for the lower branch), respectively.
    After removal of the parts to be replaced and preparation of the contact surfaces of the jaw, the mandibular component 1 can be placed, with the shoulder 5 on the upper edge of the bone, and the prosthesis with bone screws can be fixed with the wing 3 against the lateral side. of the healthy bone. The area 10 is free, and is available for laying against the previously loosened tendon of the pterygoideus lateralis muscle. With a suture thread 16 laid in groove 9, see figure 4, this contact is at least provisionally established.
    After the fossa component has also been placed and further operations have been performed to complete the operation, bone tissue will be formed in the open spaces 15, which fills the open spaces 15 and comes into contact on the outside of area 10 with the tendon held against it. Connective fibers of the tendon penetrate into the bone tissue formed in the pores, whereby an intimate connection between bone tissue and tendon and thus muscle is achieved. The bone tissue that fills the open spaces between the rods 14 forms an anchoring of that connection. The suture no longer needs to perform a function.
    Thus use is made of the insight that the formation of bone tissue can also be useful on surfaces not in contact with a bone of a prosthesis: in this case for forming a connection between tendon and prosthesis, supplemented by forming a anchoring. The anchoring is promoted in that the material of the said area extends over a large number of open spaces, or in other words, (parts of) initially hollow, now filled with bone tissue, spaces are covered to the outside by that material. The bone tissue formed forms a spatial structure in the interconnected cavities which is located within the (initially) spatial structure of the material of the porous layer.
    It is also possible to use the prosthesis according to the invention if a tendon end with the enthese with a bone particle (bone fragment) is detached from the bone to be replaced and after placement of the prosthesis that bone fragment enters into a connection with bone in bone tissue formed from the pores. Said bone fragment contains collagen of the tendon, which may be favorable for the insertion. In this embodiment, the design of the prosthesis, in particular the porous area, can take into account the presence of the bone particle (bone fragment).
    The invention (s) is / are in no way limited to the embodiments shown and described in the drawings and description. The above description is included to illustrate the operation of preferred embodiments of the invention, and not to limit the scope of the invention. Starting from the above explanation, many variations will be apparent to those skilled in the art that fall within the spirit and scope of the present invention. Variations are possible of the parts shown in the drawings and described in the description. They can be used separately in other embodiments of the invention (s). Parts of different examples can be combined with each other.
    权利要求:
    Claims (40)
    [1]
    CONCLUSIONS
    A prosthesis for at least a portion of a bone of a body, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, the prosthesis being made of a metal or an alloy thereof and provided with is of at least one area of the surface of the prosthesis, which is disposed after placement in the body, and which is formed by a layer of material provided with open spaces connected to one another.
    [2]
    The prosthesis of claim 1, wherein the open spaces are dimensioned to allow bone tissue growth therein.
    [3]
    Prosthesis according to claim 1 or 2, wherein said layer is formed by ribs, rods or bars of the material, with the appearance of a spatial skeleton or three-dimensional grid, wherein the spaces between the ribs, bars or bars are open.
    [4]
    A prosthesis according to claim 1 or 2, wherein the open spaces are formed by a tangle of short channels in open communication, each bounded by the material of the layer.
    [5]
    The prosthesis of claim 4, wherein the channels extend in a direction with a directional component parallel to the interface on the nearest outer surface of said area.
    [6]
    A prosthesis according to any one of the preceding claims, wherein the structure defining the open spaces, in particular lattice, is regular.
    [7]
    A prosthesis according to any one of the preceding claims, wherein the size of the cross-section of the open spaces is in the range of 0.25 mm - 1.0 mm.
    [8]
    A prosthesis according to claim 7, wherein the size of the cross-section of the open spaces is in the range of 0.35 mm - 1.0 mm, more in particular between more than 0.41 mm and 1.0 mm.
    [9]
    The prosthesis of claim 8, wherein the size of the diameter of the open spaces is in the range of 0.45 mm - 0.55 mm.
    [10]
    A prosthesis according to any one of the preceding claims, wherein the layer of pores is at least about 0.5 mm thick, preferably a few mm thick.
    [11]
    The prosthesis of any preceding claim, wherein the pore layer has a porosity in the range of about 50% to about 95%.
    [12]
    A prosthesis according to any one of the preceding claims, wherein said porous surface area is on the prosthesis at a location corresponding to the location of the prosthesis of the muscle on the bone for which the prosthesis replaces.
    [13]
    13. A prosthesis according to any one of the preceding claims, wherein the porous region is local and is surrounded on the outer surface of the prosthesis by pore-free surfaces, in particular smooth surfaces, of the outer surface of the prosthesis.
    [14]
    A prosthesis according to any one of the preceding claims, wherein the prosthesis is massive except for the porous area.
    [15]
    A prosthesis according to any one of the preceding claims, wherein a plurality of regions are present on the prosthesis surrounded by surfaces without pores.
    [16]
    A prosthesis according to any one of the preceding claims, wherein said porous layer is made of the same material as the adjacent regions of the prosthesis.
    [17]
    A prosthesis according to any one of the preceding claims, wherein the porous layer, optionally the entire prosthesis, is made of titanium or an alloy thereof.
    [18]
    A prosthesis according to any one of the preceding claims, wherein the surface of the material of said layer is provided with titanium oxide.
    [19]
    A prosthesis according to any one of the preceding claims, provided in or in the vicinity of said porous area with a receiving space for a suture, clamp or other device for at least initially fixing the tendon in engagement with the porous area.
    [20]
    A prosthesis according to any one of the preceding claims, wherein the open spaces are provided with a growth factor promoting the production of bone tissue.
    [21]
    The prosthesis of claim 20, wherein the growth factor is a protein selected from the group consisting of PDGF, IGF, TGF-β, BMP, FGF, VEGF and PRP.
    [22]
    A prosthesis according to any one of the preceding claims, wherein at least said layer is manufactured by means of a process of additive production technology, such as stereolithography, FDM, SLM, SLS or another 3D printing technique.
    [23]
    A prosthesis according to any one of the preceding claims, designed as a prosthesis for the mandibular side of a temporomandibular joint.
    [24]
    A prosthesis according to claim 23, comprising a head part replacing the condylar head and a mounting plate for attaching the prosthesis to the ascending branch of the lower branch, and a joint neck connecting both of these, the condylar neck having one or more of the aforementioned areas.
    [25]
    The prosthesis of claim 24, wherein a said region is provided on the antero-medial side of the condylar neck.
    [26]
    A prosthesis according to claim 23, 24 or 25, provided with a groove or passage for a suture, wherein, preferably, the groove or passage is located in the condylar neck.
    [27]
    A prosthesis according to any one of the preceding claims, wherein the prosthesis is provided with holes for fixing means, such as bone screws, for fixing the prosthesis to bone.
    [28]
    A method for inserting a prosthesis for at least a portion of a bone of a body, in particular a human body, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, the prosthesis is constructed according to any one of the preceding claims, comprising the following steps:
    a-detaching tendons from the bone area to be replaced and removing the bone area to be replaced;
    b-positioning the prosthesis at the desired location;
    c-at least temporarily fixing the tendons on the prosthesis, in engagement with said porous areas; and d-promoting bone tissue formation in the open spaces of the porous regions and allowing connective fibers of the tendon to grow into bone tissue formed in the pores of said region of the prosthesis.
    [29]
    29. Method for inserting a prosthesis for at least a portion of a bone of a body, in particular a human body, in particular a bone or portion thereof to which a tendon of a muscle is attached in the natural state, the prosthesis is implemented according to any of claims 1-27, comprising the following steps:
    a-detaching tendons from the bone area to be replaced and removing the bone area to be replaced;
    b-positioning the prosthesis at the desired location;
    c - at least temporarily capturing the tendons, with their original enthese in a bone fragment, on the prosthesis, in engagement with said porous regions; and d-promoting bone tissue formation in the open spaces of the porous regions and allowing bone healing to adhere the bone fragment to bone tissue formed in the pores in said region of the prosthesis.
    [30]
    A method according to claim 28 or 29, wherein before step b) the open spaces are provided with a growth factor promoting the production of bone tissue.
    [31]
    The method of claim 30 wherein the growth factor is a protein selected from the group consisting of PDGF, IGF, TGF-β, BMP, FGF, VEGF and PRP.
    [32]
    A method according to claim 28, 29, 30 or 31, wherein before step b) stem cells are introduced into the open spaces.
    [33]
    A method according to any one of claims 28-32, performed on applying a prosthesis according to any one of claims 24-27, wherein in step a) the at least one branch of the pterygoidus lateralis muscle, with or without original enthesis with bone fragment, is detached from the bone area to be replaced, and wherein in step c) the relevant branch of the pterygoidus lateralis muscle, with or without original enthese with bone fragment, is recorded on the prosthesis, on the porous area on the antero-medial side of the condylar neck .
    [34]
    The method of claim 33, wherein steps a) and c) are performed for the lower branch of the pterygoidus lateralis muscle.
    [35]
    A method of preparing the insertion of a bone prosthesis into a body to replace a portion of a bone to which a tendon is attached, comprising the following steps:
    a-determining (location, size, shape) of the bone portion to be replaced by the prosthesis and determining the place of attachment / enthusiasm of the tendon;
    b-designing the prosthesis on the basis of the outcome of step a, with a discrete porous area emerging into the surface of the prosthesis, corresponding to the place of attachment / enthesis of the tendon determined in step a;
    c-manufacturing the prosthesis in accordance with the design made in step b.
    [36]
    The method of claim 35, wherein the porous region, optionally the entire prosthesis, is produced by a process of additive manufacturing technique, such as stereolithography, FDM, SLM, SLS or another 3D printing technique.
    [37]
    The method of claim 35 or 36, wherein the porous region, optionally the entire prosthesis, is made of titanium or an alloy thereof.
    [38]
    A method according to claim 35, 36 or 37, wherein the prosthesis 5 is manufactured in accordance with one of claims 1 to 27.
    [39]
    39. Prosthesis provided with one or more of the characterizing measures described in the attached description and / or shown in the attached drawings.
    [40]
    40. Method provided with one or more of the attached
    Description described and / or characteristic measures shown in the accompanying drawings.
    -o-o-o-o-o-o-o-o1 / 3
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    同族专利:
    公开号 | 公开日
    NL2020651B1|2018-12-21|
    WO2018172982A1|2018-09-27|
    US20200375747A1|2020-12-03|
    EP3600165A1|2020-02-05|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    NL1042314|2017-03-23|
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