elastic joint spacer

专利摘要:
ELASTIC JOINT SPACER, RETICULATED POLYURETHANE JOINT SPACER, MENISCO SPACER, KNEE SPACER AND HIP SPACER. The present invention relates to a joint spacer, specifically a knee and hip spacer. To produce a sustainable joint spacer, sufficiently cushioned and resistant to abrasion, and which also supports very heavy loads, it is recommended that it contain - Shore-A hardness level between 20 and 77 and tensile stress values in stretches, between 20 and 60%, preferably 50%, above 3.8 N / mm2, preferably greater than 4.6 N / mm2 and even better, more than 6 N / mm2, and / or compressive stress values in compressions, between 20 and 60%, preferably at 50%, above 7.8 N / mm2, preferably greater than 9 N / mm2 and even better, more than 10.5 N / mm2, and / or - Maximum Shore-hardness level A of 85 and tensile stress values in stretches, between 20 and 60%, convenient 50%, above 6 N / mm2, preferably greater than 7 N / mm2 and even better, more than 8 N / mm2, and / or - compressive stress values in compressions, between 20 and 60%, preferably at 50%, above 10.5 N / mm2, preferably greater than 12 N / mm2 and even better, more than 14 N / mm2.
公开号:BR112016007885B1
申请号:R112016007885-3
申请日:2014-10-09
公开日:2020-12-22
发明作者:Josef Jansen
申请人:Revomotion Gmbh；
IPC主号:

专利说明:

[001] The invention concerns a joint spacer, more specifically a knee and hip (hip) spacer.
[002] To produce a long-lasting joint spacer, sufficiently cushioned and resistant to abrasion and which can also withstand very high loads locally, the invention suggests a joint spacer with Shore-A hardness level between 20 and 77 and values of tensile stress at unit stress of 20% and 60%, preferably 50%, greater than 3.8 N / mm2, desirable above 4.6 N / mm2 and, in particular, above 6 N / mm2 and / or values of compressive tension (force) to linear compression between 20 and 60%, preferably 50%, above 7.8 N / mm2, preferably greater than 9 N / mm2, and, in particular, greater than 10.5 N is recommended / mm2, and / or maximum Shore-A hardness level of 85 and tensile strength values at unit tension between 20 and 60%, much better 50%, above 6 N / mm2, preferably above 7 N / mm2 and, in particular, desirable above 8 N / mm2, and / or compressive stress values at linear compression between 20 and 60%, 50% recommended, greater than 10.5 N / mm2, preferably above 12 N / mm2 and, in particular, recommended greater than 14 N / mm2. DESCRIPTION Joint spacer
[003] The present invention relates to a joint spacer, more specifically a knee and hip (hip) spacer.
[004] Worldwide, millions of people are affected by osteoarthritis, the premature wear and tear of the surfaces of cartilaginous joints, especially in the knees and hips. As an alternative to the anterior artificial joints (endoprosthesis) associated with several disadvantages, elastic disc-shaped spacers, called "knee spacers", are available. These can be inserted into the knee through a small skin incision, after removal of the meniscus (remainder), leveling the joint surfaces and choosing the size carefully. In the joint, they replace the worn cartilage and the damaged meniscus. Knee spacers restore the space of the natural joint and thus can also correct deformities, such as X or O misalignments (valgus, varus) of the leg.
[005] Normal medial (internal) and lateral (external) menisci are tissues of fibrous cartilage in the shape of a half moon, shaped like a transverse wedge and anchored over the anterior and posterior horns in the tibial plateau. They extend the contact area between the tibial plateau and the joint rollers (condyles) of the femur (coxal bones).
[006] Generally, joint spacers can be used in other joints of the human body, such as the hip, shoulder, foot, hand or vertebra. In this case, they also include "grooves" or flat grooves that can replace only a small part of the surface of a joint's cartilage. In addition, spacers are used as lubricating and damping elements for stents. In the knee spacer, it is possible to distinguish different configurations. It replaces the meniscus and the worn cartilage of the joint surfaces, but the meniscal implant replaces only the meniscus. The replacement of the articular surface or spacer of that surface compensates for the partially worn cartilage or the initial wear of the articular surfaces, without replacing the meniscus.
[007] It is known that a knee spacer can be formed by different materials and polymers. Here, polyurethanes are suitable for their great mechanical strength and high resistance to abrasion. Basically, you can differentiate between aromatic and aliphatic polyurethanes. Aromatics tend to have more mechanical strength and, therefore, seem more suitable for the high loads that occur in a knee spacer during flexion and extension. In relation to aliphatics, aromatics have the disadvantage of "yellowing" and, therefore, they present a certain aging effect. Additionally, aromatics are also controversial because their possible degradation products may present a cancerous risk.
[008] In practice, knee spacers have not been successful so far, because implants often break, escape from the knee joint space or restrict movement. More specifically, knee spacers with physiological cushioning associated with adequate mechanical strength and resistance to fatigue are not currently known. However, physiological cushioning is desirable, as it avoids the occurrence of pain in the patient.
[009] The aim of the current invention is to provide a durable, abrasion resistant and sufficiently cushioned joint spacer that can also selectively absorb very high loads. The joint spacer must also achieve maximum congruence between the surfaces of the hinge joints and must not escape the hinge space.
[010] According to claim 1, this objective is achieved by the joint spacer. Therefore, according to the invention, the joint spacer consists, at least partially, of a material, specifically an elastomer or thermoplastic elastomer with a Shore-A hardness level between 20 and 77 and tensile stress values in elongations between 20 and 60%, preferably 50% (hereinafter referred to as 50% tensile stress), above 3.8 N / mm2, preferably greater than 4.6 N / mm2 and more recommended, greater than 6 N / mm2, and / or a maximum Shore-A hardness level of 85 and tensile stress values in elongations between 20 and 60%, conveniently 50%, greater than 6 N / mm2, preferably above 7 N / mm2 and more recommended, greater than 8 N / mm2. It should be noted here that the stress value at a specific elongation does not mean the tangent or secant of the module. It is recommended that the material does not have any effect resulting from up to 50% elongation, a maximum elongation of 70% is recommended.
[011] It is preferable that the material has a Shore-A hardness level between 20 and 77 tensile stresses at 100% elongation (100% tensile stress) of at least 5 N / mm2, preferably at least 6 N / mm2 and more advisable, at least 7.5 N / mm2, or at a maximum Shore-A hardness level of 85 tensile stress values, at 100% elongation at least 7.5 N / mm2, recommended at least 8.5 N / mm2 and even more, at least 10.5 N / mm2.
[012] Another characteristic of suitable materials is the compressive stresses (forces), although the damage to the material is caused much more by the tensile stresses that act. Therefore, according to the invention, the joint spacer consists, at least partially, of a material with a Shore-A hardness level between 20 and 77 and compressive stress (strength) values in compressions, between 20 and 60%, preferably 50% (hereinafter referred to as 50% compressive stress), above 7.8 N / mm2, preferably greater than 9 N / mm2 and even more, greater than 10.5 N / mm2, and / or maximum hardness level Shore-A of 85 and compressive stress values in compressions, between 20 and 60%, 50% recommended, greater than 10.5 N / mm2, preferably above 12 N / mm2 and more recommended, above 14 N / mm2 .
[013] This joint spacer presents a distinctive and beneficial performance of progressive pressure-compression. The elasticity falls disproportionately with increasing compression and, thus, the joint spacer becomes more rigid. In other words, the material is relatively soft, with regard to the respective level of Shore hardness, and at the same time has a relatively high modulus of elasticity across the compression.
[014] The stress values mentioned above can be reached at values of tension or compression lower than those specified, even if the joint spacer is not so strongly compressed, under the same loads.
[015] Shore hardness is often used to select materials and polymers suitable for joint spacers. Among the suitable materials known to medical technology, the very high loads present in the joints, especially on the knees and hips, can only be absorbed by materials with a Shore-A hardness level above 85. However, for high congruence and cushioning and therefore, in case of eventual pain relief in the patient, the joint spacers made with these materials would be very rigid and, therefore, less suitable for the knee. The softer the joint spacer, the greater the contact area between it and the joint surface, and the less effort, and consequently, the abrasion in the joint spacer will also be much less. In its adhesion, the joint spacer should ideally be closer to the natural articular cartilage. This includes the weakened arthritic articular cartilage, so that, if possible, it is not further damaged by the implant. A Shore-A hardness range of 20 to 77, better than 45 to 72, is tested on the material. For very heavy people, around 100 to 120 kg, the Shore-A hardness of the material should be up to 85, depending on the size of the tibial surface and the joint spacers. In this context, materials - basically elastomers or thermoplastic elastomers - are ideal. Known flexible polymers or other materials in this range of hardness cannot accumulate sufficient tension in the face of higher deformities, to withstand the forces acting on the joints, that is, the support capacity of the support material is not adequate. However, tests have already proven that materials that exhibit a marked pressure-progressive compression action are suitable for joint spacers. Materials with the same Shore-A hardness can have different modulus of elasticity and, mainly, establish different levels of tension in the face of a certain elongation or compression. In other words, the material is compressed less or more under a predefined load, with the same Shore-A hardness.
[016] The materials - mainly elastomers and thermoplastic elastomers - can soften with increasing temperature, after water absorption and storage in water over several months or under various loads (tension-induced softening or the so-called Mullins effect; Geary C et al. Characterization of Bionate Polycarbonates Polyurethanes for Orthopedic Applications J Mater Sci: Mater Med 19 (2008) 3355-3363). In addition, mechanical properties are altered due to sterilization. Materials can also solidify at very high test speeds. Therefore, the parameters specified in this invention are related to testing samples in a conditioned state at 37 ° C, after ingestion of water or synovial fluid and at the usual test speeds of the relevant standards, in a sterile state. The voltage values are determined preferably after the 5th cycle to compensate for the Mullins effect, since the amount of hysteresis can vary a lot, especially in the first cycles. Even the values already specified must be reached or exceeded after, at least, 5 months of storage in water. Thus, the materials must be hydrolytically stable. In more general terms, the materials used must preserve the parameters even after prolonged implantation in the body.
[017] As indicated earlier, softer materials generally cannot withstand the loads acting on the joints. In addition to the tensile stress values described above, at 50% - or even stretching efforts of 100% and compression of 50%, resistance to the propagation of rupture is another important parameter of the material. The softer the material, the higher the resistance to breakage, ideally. In other words, it is inversely proportional to the Shore-A hardness level. Reference values for this relationship: at a Shore-A hardness level of 55, the breaking strength must be greater than 60 N / mm (better above 70 N / mm), Shore-A hardness level of 75, above 35 N / mm (convenient above 40 N / mm). There must be a linear run through these Shore-A hardness ranges along these reference values. According to the “Trouser Tear Test” (Pants Rupture), the resistance to the propagation of the rupture is related to the sample formats.
[018] The chosen configurations of the invention are described in the claims and descriptions presented below.
[019] Suitable materials for the joint spacer are durable, biocompatible and elastic polymers, and in this case, as already mentioned, more specifically, the class of polyurethanes. But other materials can be used, such as silicones, PTFE, polysulfone, polyvinyl alcohol, poly (styrene-isobutylene-styrene in blocks) [SIBS], hydrogenated copolymers of styrene blocks (SBS, SIS, SEBS) or other polymers, depending on evolution of the technique. In addition to the various rubbers, silk or artificial silk is also used for joint spacers. It should be noted that materials with high water absorption in the order of 100% and above are suitable for these components. In addition, polymers should be exempt from low molecular weight components as much as possible, so that the desired stress values of 50% are exceeded, thus leading to the preferred properties.
[020] The elastomer or thermoplastic elastomer of the joint spacers should preferably consist of a class of polyurethanes and, more specifically, a polyurethane, polyurea or polyurethane-urea.
[021] Polyurethanes are characterized by the combination of rigid segments (formed by a low molecular weight isocyanate chain) and soft segments (higher molecular weight). According to their composition, polyurethanes present a very different physical behavior, mainly in the stress / strain curve.
[022] Isocyanates are widely described in the existing bibliography and it is possible to use practically all of them. However, compact, slightly branched and refractory isocyanates, such as Diisocyanate-cyclohexane (CHDI), Naphthalene-1,5-diisocyanate (NDI) or Paraphenylene diisocyanate (PPDI), are preferable. In addition, linear, symmetric isocyanates, such as hexamethylene diisocyanate (HDI), are considered suitable. These basic components further promote the progressive action of pressure-compression, resulting in the advantages already mentioned. Additionally, these isocyanates are very well adapted to dynamic applications. The weight of these isocyanates can be up to 50%, preferably 3% - 30% of the polymers. These preferred isocyanates can also be combined with other aromatic or aliphatic isocyanates. The diisocyanates or mixtures of diisocyanates mentioned can also be added with polyisocyanates.
[023] According to a chosen configuration of the present invention, the polyurethane mixture contains, at least partially, trans-1,4-cyclohexane diisocyanate (CHDI), cis-CHDI or mixtures thereof. Trans-CHDI is preferable because the polymer has a very high crystallinity and thus obtains the preferred properties. CHDI also leads to favored aliphatic polyurethanes. In addition, it is envisaged that the polyurethane mixture consists, at least partially, of other aliphatic isocyanates, specifically Dicyclohexylmethane diisocyanate (H12MDI) or a mixture of isomers derived or a mixture of CHDI and H12MDI.
[024] A series of formulations and components which favorably lead to preferred properties are specified below.
[025] The soft segments are very important to achieve the desired performance of the progressive pressure-compression of polyurethanes with high stress values at 50% elongation or compression and low Shore-A hardness. Preferably suitable for joint spacers are the soft biostable and hydrolysis resistant segments, based on polyolefins, more specifically, polyisobutylene (PIB) or polybutadiene (PB). In addition, the soft polycarbonate (PC) and polydimethylsiloxane (PDMS) segments are valid as relatively resistant to hydrolysis. Commonly known in the literature or in the commercial environment, medical polyester or polyether urethanes are also not bio-stable enough for long-term implants and are therefore less suitable or are not favorable, even if they can be combined in relatively small quantities. Silicone-ether-polyurethane copolymers appear to have inadequate biostability.
[026] According to the chosen configuration of the present invention, the soft segment of the thermoplastic elastomer or elastomer is a polyisobutylene (PIB) or a bifunctional polyisobutylene, preferably a hydroxyl-ended polyisobutylene (HO-PIB-OH) or amine (H2N -PIB-NH2).
[027] In another advantageous configuration, the soft segment is polybutadiene (PB), preferably with an OH end and much more preferable, the hydrogenated polybutadiene with an OH end. However, amine-tipped polybutadienes can also be used.
[028] The favorable properties of the polymer are very high when the soft segment is composed only of a PIB or PB or a mixture of these two soft segments.
[029] For GDP with an amine end, as a soft segment chain, extenders such as Ethylene diamine (EDA) or 1,4-Diaminobutane (BDA) and preferably 1,6-Diaminohexane (HDA) are suitable or 1,8-Diaminooctane (ODA). Hydroxyl-terminated PIB can be combined very well with the 1,6-Hexanediol (HD) chain extender. When using these chain extenders, each soft segment can be combined very well with other soft segments to modify and adjust the specific physical performance. Preferably, H12MDI is used, but other isocyanates already mentioned can also be applied.
[030] PIB with hydroxyl end will also result in a suitable polyurethane, with the butanediol chain extender, if the 1,3-Diacetoxi- 1,1,3,3-tetrabutildiestannoxane (DTDS) catalyst is used. Here, the polymer can also be synthesized in a one-step polymerization process, without the so-called prepolymer, used in the two-step procedure, preferably. In addition to preferred isocyanates, 4,4'-diphenylmethane diisocyanate (MDI) is also suitable as an isocyanate.
[031] The soft PB element, mainly hydrogenated polybutadiene-hydroxyl, can preferably be combined with N, N-Diisopropanol Aniline (DIPA) or 2-Ethyl-1,3-Hexanediol (EHD) chain extenders, but 2,2,4-Trimethyl-1,3-Pentanediol (TMPD) or 2-Butyl-2-Ethyl-1,3-Propanediol (BEPG) also works. These chain extenders can be used to mix the soft segment with other soft segments. MDI is preferred in this case, but the other mentioned isocyanates can also be applied.
[032] Polyurethanes are also very suitable and will lead to favorable physical properties, if the 1,3-Diacetoxy-1,1,3,3-tetrabutildiestannoxane (DTDS) catalyst is used in the polymerization. Here, as stated above, the one-step polymerization process is ideal.
[033] Polyurethane types can also be cross-linked. In this respect, water is the most suitable to achieve the desired properties. Other cross-linking reagents can also be used, such as 3-valent glycol or other polyvalent materials known in polyurethane chemistry.
[034] The preferred isocyanates for water cross-linking are HDI, NDI, PPDI or CHDI. In addition to the preferred soft segments, PIB and PB, already mentioned, a preferred soft segment is polycarbonate diol (PCD) and also, where appropriate, the butanediol chain extender (BD) or one or more chain extenders. However, the use of chain extenders is usually avoided and only water is used for cross-linking.
[035] In polyurethanes based on polycarbonate diols, polyhexamethylene carbonate diol (Cs-PCD) is generally used in medical technology. Each of these consists of only six methyl groups (CH2). However, in order to obtain softer polyurethanes and, at the same time, achieve favorable physical properties and very suitable especially for joint spacers, polycarbonate-copolymer types (polyalkylene carbonate diols) are used instead of a homogeneous Cs-PCD , formed by the hexane (Cs) pentane (C5), butane (C4) or propane (C3) units. Copolymers preferably consist of combinations with Cs / C5 or Cs / C4 or C4 / C3 units, expressed by the formula
where n = 6 or 5; or n = 6 or 4; or n = 4 or 3. In addition, types of copolymers with a decreasing number of methyl groups have much less resistance to abrasion.
[036] Therefore, a favorable formula foresees that the polymer of the joint spacers contains at least partially copolymers of polycarbonate diol.
[037] As already mentioned, the particularly favorable components of the polyurethane system are the HDI, CHDI, PPDI or NDI isocyanates, as well as the polyolefins, preferably PIB or PB and PCD as soft segments, where the aforementioned types of polycarbonate copolymers diol are preferably used for PCD. The grades of PIB or PB polyolefin can be mixed or combined mainly with PCD to achieve the types of polyurethane with high abrasion resistance in this case. The PCD proportion of the total soft segment is up to 80%, 5 to 40% recommended. The soft segments can also be mixed with other known soft segments, in particular polydimethylsiloxane (PDMS) or polytetramethylene oxide (PTMO). The addition of block copolymers of polydimethylsiloxane polycaprolactone is also suitable to achieve favorable properties. The proportion of these soft segments in the share of the total soft segments is up to 50%, preferably 3 to 35%.
[038] An even more favorable formulation provides that the polymer of the joint spacers contains - as soft segments - only polyisobutylene with hydroxyl end and / or amine, and / or polybutadiene with hydroxyl end and / or amine and hydrogenated polybutadiene with hydroxyl end and / or polycarbonate diol.
[039] The GDP with hydroxyl and / or amine ends, already mentioned, can also be linear or branched. Copolymers - such as acrylonitrile-butadiene-styrene - can also be used in polybutadiene.
[040] In addition, the aforementioned isocyanates can be mixed with other aromatic or aliphatic or cycloaliphatic isocyanates, such as 3,3'-Dimethyl-4,4'-biphenylene (TODI).
[041] In addition, in the first formulations presented, the chain extenders cited can also come in a combination of two or more chain extenders and / or cross-linked reagents (eg, glycol) in the synthesis of polymers.
[042] To improve the performance of traction, wear and especially the resistance to abrasion of the material used, it appears that, according to a favorable configuration of the invention, the material or mixture chosen of polyurethanes has nanoadditives with at least a dimension much larger than than in the other two. Preferably, the nanoadditives are configured in disk or flat format, or have higher values in two dimensions, in relation to the measure in the 3rd dimension. The nanoadditives are 10 to 50 nm wide, preferably 25 to 30 nm, and 0.5 to 1.5 nm thick, recommended 1 nm. Therefore, the performance of progressive pressure-compression improves on the one hand, and the tendency to drag is reduced, on the other hand. In nanoadditives with the specified dimensions, the material does not stiffen, the level of Shore-A hardness remains almost constant, which is desirable because of the necessary adhesion / damping to the joint spacer. However, the addition of nanoadditives increases the tensile or compressive stress values by 50%. Nanoadditives are preferably added in volume concentrations below 10%, less than 5% recommended, more preferably below 3%. Suitable materials for nanoparticles are specifically overlaid silicates, various metal oxides, carbon or Bornane particles, in addition to particles of titanium, platinum, silver or gold. But carbon nanotubes or other fibrous nanoparticles can also be added. In principle, long fiber reinforcements can be integrated into the joint material.
[043] In the material configurations identified above, tensile stress values of 50%, up to 20 N / mm2 can be achieved in the Shore-A hardness ranges mentioned above, that is, depending on the exact composition of the individual components of the polyurethanes and / or the addition of nanoparticles.
[044] To improve mobile properties or reduce the friction coefficient, it is envisaged that the polyurethane mixture may also contain polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) or other hydrophilic polymers or suitable substances. The proportion of these substances is less than 10% and the recommendation is below 3%.
[045] In a later configuration of the present invention and to improve the performance of the progressive pressure-compression of the material, the polymer or mixture of polyurethanes used may have a foam - or porous structure - in which, preferably, the material after conditioning presents the stress values already mentioned, at 50% elongation or compression in the relevant ranges of Shore-A hardness level. In principle, the porous structure can be open-pored, in the basic shape of a honeycomb, or it can be a closed-pore structure, such as a classic bubble or foam structure. Tests have indicated that pore sizes in the range of 200 μm - as is the case, for example, in polyurethane foams - quickly damage joint spacers. Pores of less than 5 μm and nanopore structures are more efficient. Thanks to the absorption of water or synovial fluid in the pores, even the most fragile materials - which do not meet the aforementioned parameters - are strengthened and can then withstand higher loads. Initially, closed cell foam structures are advantageous in terms of durability, but mixed cell structures have the advantage of absorbing liquids and facilitating fluid exchange between cells.
[046] Thus, the joint spacer contains, at least partially, a foam structure with pore sizes between 0.1 nm and 2 μm, recommended 1 to 500 nm and better 5 to 200 nm. Pores larger than 2 μm, especially 5 μm, usually result in premature wear or damage to the material of the joint spacer. In addition, open pore structures with a pore size of less than 100 to 200 nm, more specifically, retain components, such as synovial fluid proteins, to prevent the structures from hardening or calcifying. The porous structure also has the advantage, due to the absorption of liquids in the pores, to develop a support layer (fluid friction) on the surface under load. In other words, a lubrication deposit may occur on the porous substrates. Therefore, the joint spacer should preferably be porous on the surface. But it can also be laminated, that is, it does not contain pores on the surface. To improve mobile properties and achieve an efficient fluid friction value, it can also be totally or partially porous or rough at the surface level only.
[047] The substances mentioned above to improve mobile properties or reduce the friction coefficient - such as polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) or other suitable substances - can also be used to fill the pores of the foam structure or, at least, at least, reach a lubrication tank by moistening.
[048] As previously described, nanoparticles and porous structures improve the performance of progressive pressure-compression. In addition, the effects achieved are reinforced with the combination of pores and nanoparticles, more specifically the high values of tensile or compression stress of 50% can be achieved at low levels of Shore-A hardness.
[049] Another configuration of the invention - to obtain the desired favorable physical properties - provides for a non-woven porous structure or, more specifically, a non-woven nanostructure, preferably consisting of fibers with a diameter of 0.1 to 0.4 μm. The material has a thin (random non-woven) fibrillar structure of fibers, preferably woven, joined and fused at the intersections. In addition, the pores of this non-woven structure should preferably be less than 5 μm and, more specifically, less than 1 μm.
[050] In addition, it is necessary to add that the progressive pressure-compression action of the joint spacers and the aforementioned Shore-A hardness levels and 50% pressure or compressive stresses are achieved, preferably, by a foam structure or wool type, if the polymers used in a compact or homogeneous way are much more rigid. In other words, materials or polymers with a Shore-A hardness level greater than 77 or 85 may be suitable for a joint spacer, if softened by a porous structure and thus reach the desired Shore-A hardness levels.
[051] Specifically in knee spacers, the central region of the joint spacer receives a high load due to the convexity of the femoral condyles. However, in the bibliography and in the patents, there is evidence of the softness of the central area and the rigidity of the edges. However, plastics tend to drag, and the central area of the joint spacer is "stretched" during continuous operation, that is, it becomes wavy in the center or creates folds, which can generate distortions and displacement of the joint spacers. In addition, the edge area can absorb less and less load over time. To obtain a joint spacer with the characteristics of the preferred damping (adhesion), another configuration of the invention provides for the use of a material preferably more rigid for the central region and a softer material for the edges of the joint spacer. The meniscus spacer is designed so that the softer edge areas are charged first through the femur, and the stiffer central areas are charged only further ahead, through which the desired performance of progressive compression is achieved. The femoral side of the meniscus spacer has a more concave shape than the convexity of the femur, that is, during contact, the femur first touches the edges of the meniscus spacer.
[052] Here, it is recommended to use the most rigid or softest materials, already mentioned, with the respective tensile or compressive tension values of 50%. This variant can also be designed from the known polyurethanes. As a rigid material with a Shore-A hardness range preferably between 78 and 85, a material with tensile or compressive stress values below 50% of the maximum Shore-A hardness range of 77 can be used. , as a soft material, one can use a material with tensile or compressive stress values below 50% in relation to the mentioned range of Shore- A hardness level of 20-77. Preferably, the soft parts extend wedge-shaped from the edge of the meniscus spacer in the middle, and are embedded on both sides of the rigid material, with only the rigid material being present in the central area. The deformation of the soft edge areas and, consequently, the preservation of the recovery of these areas, is limited by the central rigid part, which receives the full load.
[053] In addition, the joint spacer can have a layered structure with at least three layers, that is, two cover layers and a closed central layer. In this context, the central layer and the covering layers can be made of different rigid materials, preferably, where the central layer is comparatively more rigid and the covering layers are relatively softer. It is recommended that areas of the relatively soft edge have the appropriate thicknesses, so that these areas are loaded first from a condyle, so that the joint spacer initially exhibits an exceptional high degree of adhesion. With the increasing compression of the flexible boundary areas, the joint spacer responds with more rigidity due to the relatively more rigid central layer (progressive pressure-compression action).
[054] The difference in Shore-A hardness level between the cover and central layers is greater than 5, preferably between 10 and 25. The most rigid cover layer preferably consists of a polymer with Shore-hardness level 78 to 90, 80 to 84 recommended. On the contrary, the covering layers have a Shore-A hardness level between 20 and 77 and, preferably, between 40 and 70. The hard and soft layers have tensile stress values or 50% compressive, as described in the previous configuration with soft edge.
[055] One of the two soft layers, specifically the distal layer - in the case of knee spacers - of the tibia (shin bone) can also be discarded, especially if the knee spacer is attached to the tibia. However, the advantage of the additional soft layer is that it can adapt much better to the topography of the patient's individual joint. It is worth noting that, in principle, the action of progressive pressure-compression can also be achieved, if the central layer is soft and the cover layers are rigid.
[056] Specifically in the case of sports or mobile patients, it is observed that the joint spacer can move (dislocation) and lose the ideal position in the joint. The risk is very high, especially for joint spacers developed as knee spacers, because the knee has less space for proper fixation and the proper fit of the shape cannot be achieved, unlike a joint spacer in the femoral head. To reduce the risk of displacement, the joint spacer, in particular the knee spacer, should be covered along the edge, at least partially, with a layer of porous wool or with a thin fibrillary structure tape. As an advantage in the thin fibrillar structure (non-woven and random), the surrounding structures of cells or tissues can expand. Thus, the meniscus spacer can particularly grow in conjunction with the knee capsule and contribute to correct positioning and reduce dislocation. The thin fibrillar structure preferably consists of nanofibers with diameters <0.4 μm or thicker fibers, with average diameters of about 2 μm. The layer of the thin fibrillar surface can totally or partially cover the extreme surface of the meniscus spacer at its height. It can be fully connected to the end of the meniscus spacer. But it is recommended that the thin fibrillar surface layer is connected to the knee spacer only at the distal and proximal end. In this case, the advantage is the occurrence of small relative movements and, therefore, a movement compensation between the meniscus spacer and the developed thin fibrillar extreme layer, further supporting the positioning of the meniscus spacer.
[057] According to another configuration chosen in the present invention, the joint spacer is surrounded, at least partially, by a thin fibrillar structure hose, where an additional fixing tape is placed. The hose is preferably attached to the total surface of the joint spacer tip. The fixing tape or only the hose or tape of the thin fibrillar structure without the additional fixing tape is used to connect the joint spacer to a part of the joint - in the case of a knee spacer, to the other meniscus horns or other components of the plateau tibial. It is recommended that the thin fibrillar structure be made of the same material as the current joint spacer, so that both are connected to each other by means of a disclosure adhesive.
[058] The thin fibrillar end can also be used to suture the meniscus spacer to the remaining meniscus or to the joint capsule. As an alternative or in addition, the meniscus spacer may also have one or more small holes - preferably along the outer periphery - that span its entire thickness or from the tibial surface and / or the femoral surface to the edge surface. Note that the thin fibrillar edge may also have other fibrous structures, such as woven or knitted structures. In addition, the suture lines can cross the fibrillar in the external direction. These lines (wires) that lead to the outside are preferably placed before the outside edge, or also afterwards, and can be sutured to further fix the joint spacer to the surrounding tissue structures.
[059] According to an alternative configuration of the present invention, it is offered to prevent displacement, so that the aforementioned hose is attached only to the outer edge in the form of a circular arc and extends along the ends of the circular arc to the interior of the knee. Seen from above, the hose takes the shape of C. A flexible, high-strength fixing tape, made, for example, of ultra high molecular weight polyethylene (UHMWPE) fibers or another polymer, passes through this hose. e.g., a polyurethane. The fixation tape can be carried out to the appropriate places on the sleeve or wool edge through the openings, if the hose fully covers the surface of the edge of the meniscus spacer. In a variant of this configuration of the present invention, the hose with internal fixation tape or, perhaps, only that tape is not firmly glued to the meniscus spacer, to facilitate the replacement of this spacer. After attaching the fixing tape to the C-shaped contour of the hose, the meniscus spacer is inserted and, kept inside, turned outwards, in an adjustable way.
[060] Conveniently, the fixation tape is placed on the remaining horns of the meniscus. To do this, use sewing, through clamps or clamps with automatic closing, which can be closed and then opened, or connections, respectively. The clamps or connections are made, for example, of metal alloys with shape memory. The clamp or connection - with the half firmly attached to the tape - is pressed with the other half, on the knee, with a pair of pliers. In this case, the clamp could have claws, which can "stick" to the horns of the meniscus. It is possible to reopen it through a repetition intervention, increasing the temperature above the body. In a chosen configuration, the clamp or connection made of metal alloy with shape memory can also be closed by means of a pulse of heat (temperature) [without actively pressing with pliers]. Another variation is that half of the connection is firmly attached to the horn of the meniscus and the other half is connected to the fixing tape. After attaching the tape to the horns of the meniscus, the thin fibrillar material cuff can be pressed over the connection point. It is possible to design the hose with grooves at the ends to better guide through the connection point, that is, the clamp or connection. The grooved ends of the hose can be affixed (distal) again after displacement, possibly with the help of Velcro interlocking.
[061] If it is not possible to affix over the remaining horns of the meniscus, the tape can be affixed to the holes in the tibial plateau, where the holes are drilled, and preferably, in the duct configurations (anterior or posterior intercondylar area) of the tibial plateau , more precisely at the start or end point of the front or rear horn. For this purpose, the fixing tape can be placed at the ends with pin-shaped components, using detachable clamps. The meniscus implant can also be fixed in the same way.
[062] According to another chosen configuration of the present invention, it is envisaged that the fixing tape will pass through a circumferential groove in the central layer of the joint spacer and exit in the layer of the thin fibrillar edge. The fixing tape is placed in the groove, better freely, or in the central layer. Here, the central layer of the outermost edge is thicker, which reinforces the suspension by the fixing tape. Alternatively, this tape can also be glued to the edge surface of the meniscus spacer or attached. The thin fibrillar wool layer is attached to the edge surface at the distal and proximal edge.
[063] According to another configuration, the tape is also expected to pass on a U or L-shaped mounting rail, so that the joint spacer is mounted as a detachable from the fixing tape. It is recommended that the U-shaped rail is connected to the central layer of the joint spacer. Considering that the fixation tape can remain permanently on the knee, according to the described fixation methods, it is preferable that only the joint spacer is changed in a new operation, while the fixing tape remains on the patient's body.
[064] The U-shaped or L-shaped track is preferably connected to the fixed central layer of the joint spacer, and covered on the outside by a thin fibrillar structure. According to a favorable configuration of the invention, the profiled rail is made of a very rigid material, a plastic or polyurethane or high-strength metal. The fixing tape lying outside the joint spacer and the junction with the meniscus horn can be enclosed in the thin fibrillar structure of the hose. The groove (notch) can also be integrated into the sandwich structure of the meniscus spacer.
[065] The thinnest edge around the knee spacer, the thin fibrillar structure, the hose or the fixing tape are also suitable items for marker placement, where the knee spacer or its position and movement can be visualized with the help of imaging methods. The markers can be small pins, thin lines or threads or a ferromagnetic layer, preferably attached to the soft and very flexible structure of the border. The edge or the fixation tape itself can be made of X-ray-proof material or other material suitable for the respective imaging methods. Placing markers on the edge is a great advantage, as it can prevent deformation of the joint spacer. If the markers are placed directly on the joint spacer, there is a risk that they will detach over time due to dynamic loads and penetrate the joint cavity.
[066] According to an even more favorable configuration of the present invention, the knee spacer has two projections arranged on the innermost edge as "fit to shape" or "interference fit" in channel configurations or holes, and then on the plateau tibial. These projections are (front view) L-shaped, preferably made of the same material as the central layer of the joint spacers and connected with this material fitting. As an alternative, the protrusions or protrusion sections may also have a thin fibrillar structure or another suitable structure, which allows them to be sutured to the horns of the meniscus. The protrusions are specifically designed to pass only inside and not beyond the anterior or posterior end of the tibial plateau. They prevent only a lateral outward movement of the joint spacer, but no movement in the anterior / posterior direction. Therefore, they can also be flexibly developed to support the anterior-posterior movement of the knee spacer. According to a configuration chosen from the present invention, the ends of the protrusions are configured as pins and inserted into the previously drilled holes, formed in the duct configurations and, inside, prevent the displacement of the joint spacer. The transition from the protrusions to the base of the knee spacer can also be rounded and integrated into the contour. The protrusions can be connected to the remains of the meniscus or to the cruciate ligaments, where, in this case, preferably, the distally directed part of the L-protrusion is absent or exists in a very small format.
[067] It should also be noted here that the methods known to date and the fixing elements described in the patent literature or the latest generation can also be combined with the invention.
[068] In addition to the fixation methods already mentioned, the shape of the meniscus spacer has a lot of influence on the risk of displacement. According to the evolution of the technique, the meniscus spacers made with flexible materials are thicker on the outer edge than in the central region, because the meniscus or the replacement of the meniscus which, seen from above, has an arc shape, and in the transversal view, wedge-shaped, integrated into the spacer. However, tests indicated that this form of meniscus spacer easily results in displacements. There are also knee spacers with fairly uniform thickness and meniscus spacers with anchoring ribs on the tibial side of the knee spacer, which fit into the corresponding cracks in the tibia or are fixed inside it. To avoid or reduce the risk of displacement, another alternative configuration of the present invention is thicker in the anterior and posterior area than in the central area of the meniscus spacer and at least in a location on the outer edge, it is equal or preferably thicker, it is more thinner than in the central area of the meniscus spacer, where, seen from the center of the contour of the circular edge, it extends at an angle of 90 °, recommended 45 °. The position directly behind the center of the border is particularly preferred. In addition, the central outer edge in the area already described has the lowest height of the entire edge of the meniscus spacer. It is evident that this modification of the shape can be combined with the settings already described for fixing the knee spacer to reduce the risk of dislocation.
[069] The following preferred method is applied for the purpose of implanting the knee spacer. After opening the internal space of the knee, the fixing tape is connected using the options already described to the tibial plateau. Subsequently, the knee spacer is inserted into the C-shaped duct, generated by the fixation tape. Here, the knee spacer can be threaded into its recesses (grooves, profiles) and adjusted to the shape, or just positioned on the fixing tape. It is possible to exchange it for a new one after a stipulated period. To do this, open the described groups, if necessary.
[070] According to another embodiment of the invention, the joint spacer is developed as a hip (hip) spacer and can be slid over the femoral head in the form of an elastic shell-shaped cover. Beneficially, these hip spacers can be used without any bone removal, in a minimally invasive way. As an advantage, the hip spacer - preferably around the proximal pole - has an opening for the execution of the femoral head ligament.
[071] According to a chosen configuration of the invention, the hip spacer is separated from the hole for the edge of the shell-shaped cover, in which an area of overlap is provided along the dividing line. In other words, the hip spacer is moved downward (caudal), like a "waist opening", to slide it around the femoral head, if the ligament of that head has not been isolated. It is recommended that the outside of the overlap area has several buttons on the inside, where the respective recesses at the bottom of the overlap area are inserted. In this case, the buttons are preferably arranged along a curve of the media. Alternatively, other means of connection are provided, in the form of "nozzles", "pins", or pressure buttons, ropes or other devices suitable for closing and fixing, such as a Velcro fastener or adjustable connections with swivel joints or hooks. barb (carabiners) or other quick connections. More specifically, this is called a beveled shawl joint (in the scarf-joint style), as the term already known for joinery joints. A material fitting connection is also possible, gluing or welding. In addition, the separation of a hip spacer can be closed by tacking or stapling. A zipper or jagged projection is also a suitable connection. It is preferable that the zipper-style connection is designed as a toothed set in the form of puzzles.
[072] As it is preferable that the joint spacer is designed as elastic, it can be slightly undersized in relation to the femoral head, to facilitate its connection with the mentioned head, in an adjustable way and with interference fitting.
[073] In an alternative configuration, the hip spacer can be closed proximally and developed without separation, if the ligament of the femoral head has been separated. However, for this application, the hip spacer can be isolated from the equator to the free edge, to facilitate the act of pulling it over the femoral head. The separation can be made in a simple incision or with an overlapping area in the form of waistband opening, for example.
[074] The free edges of the two poles of the hip spacer can be made entirely or partially of the layer of porous wool of a fine fibrillar structure. As an option, it is possible to connect a tape or, for a knee spacer, a hose with a thin fibrillar structure to the free edge, which goes beyond the ends of the free edge, if necessary. It is possible to use the thin fibrillar tape itself or a fixation tape located on the cuff to attach the hip spacer to the neck of the femoral head, eg, tying the ends of the tape.
[075] The materials and material structures suitable for the hip spacer are included in the previous descriptions presented for joint or knee spacers. In particular, the hip spacer can also be made partially from degradable materials or a matrix, which transform into the surrounding cell and tissue structures and replace or complement the material or matrix. The shape and concept of the hip spacer can also consist of tissue culture materials, that is, produced with the help of cartilaginous tissues generated by tissue engineering.
[076] Like the hip spacer, the knee spacer is made of a homogeneous or porous material and / or contains a multilayered structure. A sandwich structure with a stiffer inner center layer and softer outer layers is envisaged. However, an inner core layer and a soft outer cover layer can also be used. The internal side in front of the femoral head can be adapted very well to the topography of each patient with a femoral head, if it is very soft. The inner side of the hip spacer could also be attached to the femoral head with a suitable adhesive. For example, the underside can be sprayed with bone cement to compensate for the inconsistencies between the hip spacer and the femoral head. It can also be rough or have a wool-like or foamy structure, to obtain better adhesion on the inner side or the inner layer. Bone structures can grow in these porous structures. Therefore, the inner side consists, for example, of hydroxyapatite, calcium phosphate, titanium or other suitable substance, which favors partial bone growth.
[077] The hip spacer can be basically developed with the described material and with the sandwich structures, also in the form of a socket, so that it is not only positioned on the femoral head, but inserted in the acetabulum. In addition, the hip spacer can be used as a cushion for hip prostheses, in the form of a head covering or a fitting.
[078] Furthermore, the material configurations and sandwich structures described in this invention can also be applied to other joint spacers to be used in other joints (disc, shoulder, foot and hand) inside or outside the human body, such as orthoses . They can also be used as animal joints, like horses. In more rigid configurations, the materials can also be used to replace tendons or ligaments, such as the cruciate ligaments in the knee joint.
[079] In addition, the polymers described are suitable for other implants in the human body, such as in vessels, heart valves and other valves in the human body, as well as in pump and ventricle diaphragms in artificial hearts and ventricular assist devices. In addition, they are suitable for ophthalmic implants, such as intraocular lenses or artificial corneas.
[080] Specific configurations and others chosen from the present invention are explained below, with the support of the figures, namely: Figure 1: Stress-strain curves, Figure 1a: Tibia and femur of a left knee with medial meniscus spacer (left) .) and lateral (right), Fig. 1 b, c: Lateral view of the knee slightly flexed from the lateral (b) and front (c) side, Fig. 2 Top view of a tibial plateau with the contours of the edge of the spacer medial (left) and lateral (right) knee, Fig. 3 ai: Different views of a medial meniscus spacer with a sandwich structure (in load-bearing condition), Fig. 4 ai: Different views of a lateral meniscus spacer (in load-bearing state), Fig. 5 jl: Different views of lateral meniscus spacer with soft edge, Fig. 6 a, b: Lateral meniscus spacer with rounded edge surface, Fig. 7 a , b: Medial spacer with edge made of wool-like structure (3D view (a) and section view (b), according to Cut B1-B1 of Fig. 3), Fig. 8 ac: Medial spacer with flattened sleeve containing fixation belt, Fig. 9 ac: Medial spacer with sandwich structure, Fig. 10 a, b: Medial spacer with sandwich structure, Fig. 11 a, b: Medial spacer with profiled rail, Fig. 12 Medial spacer with sandwich structure and open groove, Fig. 13 a, b: Medial spacer with sandwich structure, with detachable mounting rail, Fig. 14 ae : Medial spacer with sandwich structure, with projections, Fig. 15 ae: Lateral meniscus implant with sleeve containing a fixing tape, Fig. 16 af: Lateral (femoral) joint surface spacer, Fig. 17 a, b : Lateral (femoral) joint surface spacer, Fig. 18 Section view of a lateral joint surface spacer, Fig. 19 ae: Lateral (tibial) joint surface spacer, Fig. 20 ad. Hip spacer (open ab, closed cd), on a femoral head with femoral head ligament, Fig. 21 ae: Hip spacer and Fig. 22 ab: Cross section through the hip spacer with a chamfered shawl joint (A - above), an oblique cut (A - below) and plane view of interspersed teeth (b) of the separate hip spacer connection.
[081] The abbreviations used below have the following meaning: the anterior posterior p I Internal central side of the knee of a knee spacer The external side of a knee spacer
[082] Figure 1 shows the range of characteristics of the tensile-strain curves of the preferred materials. More specifically, it indicates the tensile stress values of 50% of the materials in the Shore-A hardness range of 20-77, which must be above 3.8 N / mm2, preferably greater than 4.6 N / mm2 and , more recommended, more than 6 N / mm2. Figure 1 also shows a stress (force) curve with a resulting behavior that must be avoided, except that the yield point should reach very high values, above 10 N / mm2. The S curve ("process S") illustrates that a suitable material with an appropriate tensile stress of 50% may have much lower values of elasticity modules and tensile stress in stretches below 50%, as in the other curves shown.
[083] Figs. 1 a-c show different perspectives of a knee joint (left) 10, as well as parts of a femur 12 (femur) and a lower leg 13 (tibia). Between the articular surfaces 14, 14 'are placed the meniscus spacers 15, 15', which replace the scraped and damaged (natural) meniscus. To protect the material of the meniscus spacer 15, 15 ', the forces to be emitted must be distributed over the surface subject to the load, as much as possible. Therefore, the shape, especially the contour of the edge of a knee spacer 15, 15 'designed for the tibial plateau 14, plays a central role. The highest loads occur in the leg position practically completely stretched, as shown in Fig. 1b. In this slightly flexed position, the tension in the anterior half of the knee spacer 15, 15 'is at its maximum, due to the posterior ascending femoral condyle in relation to the tibial plateau 14, and the resulting expansion of the cavity 16. In addition, the surface of tibial plateau support 14 is reduced from anterior to posterior due to the duct (the posterior intercondylar area). The posterior half of the support surface is used mainly to roll the condyles 17, 17 'in more flexed positions, where smaller loads occur.
[084] Fig. 2 shows that the contour of the edge 20 and, therefore, the load bearing edge of the knee spacer 15, 15 'is similar to a fingerprint, with the front part wider and the back more narrow. In the specific illustrated configuration of the present invention, the front half is 10-25% wider than the rear half. The outer side of the medial border contour and the lateral meniscus spacer along the anterior-posterior axis MA-MP, LA-LP is thus configured as a very circular arch (arrow 21). Here, the outer edge of the contour of the edge of the lateral meniscus spacer 15 'is much closer to a circular arch than the outer edge of the medial meniscus space 15 (compare Arrows 22, 22'). The inner side of the edge contour 23, 23 'facing the circular arch is concave in shape from the widest to the narrowest part of the supporting surface. The edge contour thus formed 21 of the medial and lateral meniscus spacer 15, 15 'adapts very well to the supporting surface of the tibial plateau 14, and distributes the load over the largest possible area. In addition, the risk of displacement or obstruction is reduced. To avoid or further reduce the risk of displacement, the anterior and posterior parts of the meniscus spacer 15 'are thicker than the central area of this spacer 15' and at least one area on the outer edge is the same thickness or is preferably , thinner than the central part of the meniscus spacer, where the area seen from the center of the contour of the circular edge extends to an angle of approximately 90 ° 24, better an approximate angle of 45 ° 25.
[085] The tibial surface of the 15, 15 'meniscus spacers is conveniently individually adaptable to the topography of the patient's tibial plateau. As an option, the tibial and femoral surface of the knee - bone and cartilage of the preferred coverage - is generated from a 3D model of statistical data from a group of patients with specific population properties. A shape model indicates the average shape of a larger number of a group with similar shapes, with which the variation of shapes in that group can be illustrated. Here, patient groups can be classified according to the classification of the clinical severity of arthritis, and in addition, patient groups can also be assessed by gender or by age / weight groups or other criteria, such as ethnic origin. Generally, an individual's knee shapes are generated from CT (Computed Tomography) or MRI (Magnetic Resonance) images. Throughout the process of generating a 3D shape model, the misalignment of each knee shape added to the group must be corrected for physiologically possible alignment of the leg. In practice, this depends on the individual circumstances of the patient and, in this specific case, on the ligaments or whether they are "loose" or "loose" or "contracted". As a result, for example, a patient with a loose ligament may have a correct leg position by inserting a knee spacer more easily than a patient with a contracted ligament, in which the cavity to be used for the knee spacer knee is too small for normal leg alignment. Therefore, it is necessary to consider these last criteria when generating the 3D shape models in the groups to be divided, that is, through the specified degrees of leg misalignment.
[086] The femoral surface of the meniscus spacer 15, 15 'results from femurs with angled or flexed (0-40 °) positions of the femur, in which maximum forces occur. Preferably, the printing area is at flexion angles between 6 ° and 28 °, again, in the area of the mean value of that angular range. However, the impression of the femoral side is conveniently obtained from various positions of the femur or by rotating the femur within the range of preferred angles, in which the aforementioned complete angular range does not need to be molded. This modeling greatly reduces the risk of displacement. The impression of the femoral side can be done individually for each patient or according to the previously described 3D statistical models of shapes. From there, one can derive pre-assembled or prefabricated spacers, belonging to the respective models of 3D shapes on the one hand, supplied in various sizes and thicknesses, on the other hand. The classification occurs according to the thickness, because the non-physiological alignments of the leg (valgus / varus) or according to the patient, the weight and wear of the cartilage covering the knee, it is possible to compensate different joint cavities in this way.
[087] The following method is suggested, preferably, to select the appropriate thickness of the knee spacer and the shape of that spacer. With one or more imaging processes, the patient's leg is recorded, first in a fixed condition under load, in which the tibia and femur come into contact and the leg is misaligned, and then, in a straightened condition with the position correct leg, in this case, preferably, from the front and side views. In the second register, the resulting cavity between the femur and the tibia can be applied to define the thickness. However, preferably, the difference in distance between the femur and tibia in the two images is used to select the appropriate thickness of the knee spacer. It will be advantageous if this is done in a simple and economical 2D image, such as an X-ray. In addition, it is also advantageous, based on the characteristic milestones or other aspects of the individual patient in the 2D image, that a statistical 3D shape model and therefore the correct shape of the knee spacer is completed - thus, a Pre-assembled or prefabricated knee can be selected. The position of the femur in relation to the tibia can be seen in another lateral image, obeying one of the positions of maximum flexion of the leg already mentioned, which is important for the impression and, therefore, for the shape of the knee spacer.
[088] Figs. 3 a-i show the medial meniscus spacer 15 and Figs. 4 a-i, the 15 'lateral meniscus spacer. The transitions between the edge surfaces formed by the edge contours 20 and the surfaces 31 of femoral meniscus spacers 15, 15 'are rounded (Arrow 30) because the femur 12 slides over the femoral surface 31 and rolls. The transitions between the edge surfaces and the tibial surface 32 of the meniscus spacer can be rounded (Fig. 4, Arrow 40) or not (Fig. 3, Arrow 33). More specifically, this latter possibility occurs if the meniscus spacer 15, 15 'is attached to the tibial plateau 14 and, therefore, no relative movement can occur between the two. However, it is preferable that the meniscus spacer 15, 15 'is mobile on the tibial plateau 14.
[089] The previously described generation of the tibial and femoral surface 31, 32 of the meniscus spacer varies the height of the surface of the lateral border along the circumference. The edge surfaces in the medial or lateral meniscus spacer 15, 15 'are, on average, higher on the posterior and anterior sides than on the lateral surfaces, with the highest occurring, in particular, in the transition from the posterior to the posterior side. inner edge surface. In addition, the surface of the inner edge of the medial meniscus spacer 15 in the anterior half near the transition to the posterior half (between sections g and i in Fig. 3) is the thinnest. The tibial plateau 14 is tilted or "tilted" in this area in the lateral direction from the medial to the level of the plateau, in particular, the inner edge (see Fig. 1c and the cross-section of Fig. 3i). The thicker the spacer here, the higher the risk of lateral dislocation due to the direction of the spacer's vertical load. In contrast, in the lateral meniscus spacer 15 ', the inner peripheral surface is higher or, depending on the wear in the valgus position and the flattening of the tibial plateau 14, it is approximately the same height as the outer edge surface. The lateral tibial plateau 14 has a concave shape and is positioned well perpendicular to the leg axis (without inclination), where the resultant force vector is basically coaxial with the vertical position of the legs, so that the risk of lateral displacement of the meniscus spacer side is smaller.
[090] In Fig. 4 d and I, the thinnest point of the minimum height 41 of the outer edge appears, where, at the same time, the thickness at that point is equal to or, preferably, less than in the central area.
[091] The tibial surface 32 of the meniscus spacer 15, 15 'is quite convex and the femoral surface is 31 concave. The curvature of the femoral surface 31 of the meniscus spacer 15, 15 'is conveniently greater than that of the femoral condyle, so that the meniscus spacer 15, 15' is tensioned first at the elastic edges, which guarantees high cushioning.
[092] Unlike the representations in Figs. 3 and 4, the edge surface of the meniscus spacer does not necessarily have to be in the "vertical" direction, but it can also follow the plane formed by the leg axis and the anterior-posterior direction (sagittal plane), as shown in Fig. 5 In addition, from the point of view of production, the area of the edge can be aligned to facilitate demoulding of the spacer on the production tool.
[093] In general, through this molding, the meniscus spacer 15, 15 'follows the natural movement of the knee, adjusts to each flexion of the joint, due to the high adherence of the material, as described in detail below, and has self-centeredness. In normal movement, displacements, restrictions on movement or obstruction of the spacer due to excessively high tension and possible extensive damage can be avoided.
[094] It was explained in detail that, according to a specific configuration of the invention, the joint spacer with a sandwich structure has a progressive pressure-compression performance. Fig. 3 shows an example of a spacer with a sandwich structure containing a central layer 34 and two cover layers 35, 35 '. The tibial cover layer 35 is of uniform thickness, according to a specific configuration of the invention. The cover layer 34 with almost constant thickness joins this cover layer 35, preferably along the entire surface. However, the thickness of the covering layer 34 of the medial meniscus spacer 15 can become thinner, especially between the MA-MP line (Fig. 2, LA line on the lateral meniscus spacer) and the inner edge (see Fig. 3 g), to ensure that the risk of lateral dislocation in the growing tibial plateau in the center of the knee can remain low. In addition, the cover layer 34 need not extend fully to the edge of the spacer. The tibial covering layer is approximately 3 mm thick, better between about 0.2 and 2 mm. The cover layer 34 has, as a function of the total thickness of the meniscus spacer 15, 15 'and the knee cavity, a recommended thickness in the range of around 3 -10 mm. The femoral covering layer 35 'accompanies the covering layer 34 at the top, with a non-uniform thickness distribution, relatively thin in the center and with increased thickness towards the edge. The soft cover layers 35 and 35 'with the thickest edge area can cushion shock loads very well. The high flexibility of the sandwich structure ensures that the 15, 15 'meniscus spacer can adapt to knee movement during flexion and extension. This further reduces the risk of dislocation.
[095] In another embodiment of the present invention, the central layer 34 of the meniscus spacer 15, 15 'can be thicker in the direction of the circular arc-shaped outer edge, that is, if the spacer described below for Fig. 9 b is affixed with an additional circular tape to the tibial plateau 14. Seen from above, this thickening is an extra C-shaped reinforcement in the central layer, along the respective edge.
[096] The soft outer core layers 35, 35 'of the sandwich structure of the joint spacers 15, 15' preferably consist of low friction material, resist abrasion and are particularly hydrophilic or are additionally coated with a thin layer of this material. In another alternative configuration, a central layer 35, 35 'has a rough surface or is associated with a layer of, for example, hydroxyapatite, to grow together with the surrounding tissue structures or the bony side of the joint. The sandwich structure described above or its individual layers are preferably made of homogeneous material. However, all layers or just individual layers, conveniently the outer ones can also consist of the described structures. In addition, the joint spacer can also have other intermediate layers to achieve, for example, a lower level of stiffness differences or to increase the stiffness range. In addition, the individual layers cannot be bonded by laminar bonding, but joined only at the edges or, optionally, also sliding between them.
[097] Figs. 4 jl show configurations of the meniscus spacer, in which only the edge area has a sandwich structure and the periphery of this spacer, made of more rigid material, is at least partially inserted in a wedge-shaped ring, consisting of softer material around the circumference. The edge parts can also be configured differently than shown in the figures, eg the soft material can be superimposed on the more rigid material in the edge area, or the edge is made of soft material over the entire thickness .
[098] To reduce the risk of dislocation in sporty or more mobile patients, the edge surface of the meniscus spacer 15, 15 'in another specific configuration of the current invention is covered, along the entire circumference, by a layer of wool porous 60 of fine fibrillar structure (random, non-woven) [Fig. 6], in which the surrounding cell and tissue structures can grow without forming tissues marked by hardening and scarring. Thus, the meniscus spacer 15, 15 'can adhere to the knee capsule and contribute to positioning and reduced displacement. According to another configuration, it is expected that the thin fibrillar border layer 60 will be connected only to the distal and proximal border to the knee spacer (Fig. 12b, Arrows 120, 121). The advantage here is that if small relative movements occur, motion compensation will be triggered between the meniscus spacer 15, 15 'and the thin fibrillar edge layer, and the positioning of the meniscus spacer is still supported. For this, according to a specific configuration, a flat sleeve 70 with a thin fibrillar structure is attached to the edge surface of the meniscus spacer (Fig. 11, Fig. 7).
[099] In an alternative configuration to avoid displacement, it is expected that the hose 70 will be attached only to the outer edge in the form of an arc, and exceed the ends of the arc to the inner side of the knee (Fig. 7). Thanks to this design, the hose 70 has a C-shaped configuration, seen from above. Inside, there is a flexible and highly resistant fixing tape. This fixing tape 71 can be directed outwards at corresponding points on the sleeve 70 and the wool edge through openings, when the sleeve is placed around the entire circumference of the peripheral surface of the meniscus spacer 15, 15 '(Figs 8 and 11).
[0100] Fig. 8 shows a configuration in which the fixing tape 71 extends in a notch or recess of the circumference 80 to the central layer 34 and is directed from the edge of the thin fibrillar layer 60, in the same way as already described. The fixing tape 71 or reinforcement fibers of the same type and shape used here can move freely in the notch 80, but they can also be integrated with the central layer 34 and fixed, as in Fig. 9. There, the central layer 34 is thickened to the outer edge, thus strengthening the suspension, when attaching the fixing tape 71. As an option, this tape 71 can be glued only on the edge surface of the meniscus spacer 15, 15 'or else attached with the fixing tape . The layer of fine fibrillar wool is joined to the edge surface, at the distal and proximal edge.
[0101] In another configuration, it is envisaged that an L-shaped transverse track 100 passes around the circular arc (Fig. 10), the distal or tibial side releases a circumferential notch 101 into which the fixing tape 71 is inserted. According to the fixation methods already described, this tape 71 can be permanently on the knee, so that, during a new operation, only the meniscus spacer 15, 15 ‘is changed. The outer area of the L 100 profile is preferably covered by a thin fibrillar structure. The profiled rail 100 is preferably connected to the solid central layer 34 of the meniscus spacer 15, 15 'and is made of very rigid polyurethane, a high-strength plastic or metal. The fixing tape 71 in a lying position outside the meniscus spacer 15, 15 ’and the junction with the meniscus horn are, according to the specific configuration of the present invention in Fig. 11, enclosed in a thin fibrillar hose structure. According to the configuration of the current invention, the notch 101 is integrated with the sandwich structure of the meniscus spacer 15, 15 '.
[0102] Fig. 12 illustrates another configuration of meniscus spacer 15, 15 'with profiled rail 122, which fits in an adjustable way to the edge surface of this spacer, in the form of an arc or other shape, but not firmly glued to the spacer. . The profiled rail 122 can also extend around the entire edge surface of the meniscus spacer 15, 15 '. Thanks to this configuration, the meniscus spacers 15, 15 'can be removed from the profile rail 122, raised and exchanged. In this configuration, the additional profile can be discarded, so that the fixing tape or possibly with a thin fibrillar cuff around it, is placed on a C-force around the meniscus.
[0103] In another configuration, it is provided that medial and lateral knee spacers 15, 15 'are joined by means of a one or two-piece fixing tape 71. Here, the end of the front tape of a spacer is connected transversely to the end of the other spacer. If two or possibly more two-piece fastening tapes are used 71, the connection will preferably be made using quick couplings or connections, such as buckles, pressure buckles, tongue and crease buckles, the lengths of the tapes can be adjusted simultaneously. In that case, the change in length can take place by means of a separate element, eg, an elastic band or other special clamps or (fasteners) the buckles used in backpacks, suitcase strap tensioners, straps as used as cable clamps. The items listed above can also be used in previous versions. After the coupling is activated, the hose with a fine fibrillar structure can be pressed on these elements or on the elements used to change the length, in the same way as described above.
[0104] Fig. 13 shows another configuration of the invention, in which a meniscus spacer 15, 15 'has two projections 131, 131' on the inner edge 130 and on the ends of the outer edge, which, in principle, point outwards, then in the distal direction 131, 131 'and they fit in the configuration of the channel already mentioned, in the tibial plateau 14, in an adjustable way. These projections in the form of 131, 131 'in the frontal view are preferably made of the same material as the central layer 34 and are connected there. The projections 131, 131'or sections of the projections 131, 131 'may also alternatively consist of a thin fibrillar structure or another suitable structure that allows the projections 131, 131' to be sutured to the horns of the meniscus. They can also be resiliently adapted to facilitate movement of the anterior / posterior knee spacer 15, 15 '. In addition, the ends of the projections 131, 131 'can be made as pins, protruding from the holes in the channel configurations, thus preventing the displacement of the 15,15' meniscus spacers. It is recommended that the edge surface of the meniscus spacer 15, 15 'be covered with a layer of thin fibrillar material.
[0105] Other configurations of knee spacers are described below. Fig. 14 shows the lateral meniscal implant 140 that replaces only the meniscus in the knee. It is similar to the natural meniscus, shaped like a crescent moon seen from above, and shaped like a wedge, in the transversal view. The tape around 141 - with an outer sleeve-shaped sheath 142 - is constructed similarly to the meniscus spacer. The meniscus implant can also be combined with other elements already described, to fix and, thus, avoid dislocation.
[0106] Fig. 15 shows a chosen configuration of a lateral spacer of "femoral" joint surface 150 for people suffering from early stage osteoarthritis, when the meniscus is still in a state that does not indicate total removal. The joint surface spacer 150 is placed in the concave channel of the tibial plateau 14, formed by the remaining meniscus in the knee. This joint surface spacer 150 is angled towards the edge, on the tibial side, to allow the combination of the contours of the tibial and femoral edges. As with the meniscus spacer, there is no edge surface. The tibial side of the femoral joint surface spacer may also comprise projections to fill partially defective or amputated menisci. However, the border contour can be rounded (Fig. 16, Detail W). In addition, the joint surface spacer may have a thin fibrillar structure (Fig. 16). As an option, the contour of the inner edge can have an edge surface (Fig. 17), so that the contours of the tibial and femoral edges being combined extend only to approx. 270. The femoral shape of this spacer is derived in an identical fashion to the femoral side of the meniscus spacer and is concave. The tibial shape is connected.
[0107] An alternative configuration of the joint surface spacer as "tibial" exists basically in a relatively flat shape, or as a disk of almost uniform thickness, before being placed under the meniscus. Fig. 18 shows a lateral spacer of tibial joint surface 180. However, in the medial-lateral direction, the cross-section can also be wedge-shaped with a point. The tibial surface of the joint surface spacer 180 results in a similar manner to the tibial surface of the meniscus spacer. This joint surface spacer configuration can also have a thin fibrillar structure at the edge. This structure allows to fix or sew the surface spacer of the femoral or tibial joint to the elevation above or below the meniscus or capsular structure. The two forms of joint surface spacers can also be used to straighten misaligned feathers (valgus, varus).
[0108] The meniscus or joint surface spacer and, in particular, the configurations of its materials and sandwich structures, are suitable for the appropriate modeling as a sliding, disk-shaped surface for unicondylar or bicondylar prostheses, generally made polyethylene. The elasticity and cushioning characteristics of the sliding surfaces against the very rigid sliding surfaces of the latest generation are very advantageous. For bicondylar prosthesis, two discs (medial and lateral) are also - as well as the endoprosthesis - connected to the respective internal border. The underside of these dishes is flat, it can also be different, eg in convex shape. For this application, the sandwich structure can be designed as a very soft central layer, combined with more rigid cover layers, in which case the cover layers are quite slippery.
[0109] The hip spacer 190 (from Fig. 19) is an elastic covering over the femoral head 191, preferably used in a minimally invasive manner, without bone and with minimal removal of tissue. Fig. 19 shows the schematic application of the hip spacer 190 around the femoral head 191. The hip spacer 190 has a circular or elliptical opening 192 for implementing the femoral head ligament 193 close to the proximal pole. The opening in the distal pole leads to the distal side of the femoral head 191, on the other side of the equator and to the neck of the femur. In the downward direction (caudal), the hip spacer 190 is isolated, much like a "waistband opening" (Arrow 194), to slide it 190 around the femoral head 191, if the ligament of that head 193 is not isolated. The thickness of the hip spacer 190 is sliced in the waist area along a strip of meridian arch, preferably divided in half. The inner side of the outer half has several buttons 195 that fit into the holes 196 of the inner half, close and secure the hip spacer 190 around the femoral head, 191 like a push button bar. As shown in Figs. 19 and 20, buttons 195 are arranged in two rows along the median arc. As the hip spacer 190 is preferably designed with a lot of elasticity, it is possible to undersize it in relation to the femoral head 191 to facilitate the fixation of the adjustable and interference fittings on the femoral head 191.
[0110] In a specific alternative configuration, the hip spacer 190 can be closed proximal and / or also projected without opening, if the femoral head ligament has been separated previously.
[0111] The proximal half of the hip spacer 190 is preferably spherical on the outside and slightly deformed, spherical to ellipsoidal, on the inside. Above the equator, in addition to the distal part, the outer side of the hip spacer is ellipsoidal and the inner side is, again, slightly deformed, spherical to ellipsoidal, depending on the cutting plane. The geometry of the hip spacer is best formed by a spherical and circular-ellipsoidal half-shell on the outer side. Here, the sample diameters are 58 mm in the circular or spherical part and 32 mm in the short axis of the ellipsoid. The possibility of other absolute dimensions and diameter ratios is evident. The overall result is an irregularly distributed coating thickness, but a uniform thickness is also possible. In the case of the proximal hip and closed caudal spacer, it is flattened close to the proximal pole on the inner side, according to the natural flattening of the femoral head, from where the ligament of that head proceeds.
[0112] As an option, the hip spacer 190, its geometry and thickness distribution can be adapted to each patient. Thus, the inconsistencies of the femoral head and the acetabulum, especially the worn ones, can be more efficiently compensated. Here too, the inner surface of the hip spacer, located at the distal part of the equator, can vary in a circular shape to better adapt to the neck of the femoral head (Fig. 20c). The distal half of the hip spacer can lead to the smallest circumference of the femoral neck or end first, as shown in Figs. 19 and 20.
[0113] Fig. 20 illustrates the sandwich structure of the hip spacer. To achieve the maximum possible space for the compensation of congruences between the femoral head and the acetabulum, which is preferably conferred by the soft material, the rigid central layer can be restricted to a partial surface of the femoral head, which means a very heavy load. Therefore, the central layer is preferably developed in the form of a spherical crescent moon 200. The opening angle of the spherical crescent moon of the central load-bearing layer is less than 125 °, preferably less than 105 °. Here, the central layer extends distally beyond the equator, starting at the proximal region of the proximal opening, so that the hip spacer closure bar consists entirely and preferably of the softest material. Therefore, the pressure peaks in the incompletely covered hip joints can be specifically cushioned, where the maximum pressure is shifted close to the edge of the socket. The highly tensioned parts of the joint are supported; at the same time, the caudal and very soft hip spacer promotes, in part, the compensation of congruences.
[0114] Various configurations for closing and securing the separate hip spacer have been described previously. Fig. 21 shows the chosen settings. Fig. 21a (upper half) shows a chamfered shawl joint 211 in the cross section of the hip spacer 190, which also gives rise to an area of overlap of the separation. Instead of 2 hooks, it can also contain only one. The hook blade connection 211 can also be used as a prefabricated component in the molding process (eg, in injection molding) of the hip spacer 190, through insertion into the mold cavity or subsequent gluing in the spacer hip 190. Fig. 21a (bottom half) shows a separation of the hip spacer 190, in the form of an oblique cut 212 - in this case, the separation surfaces and the overlapping area can be glued or welded, for connection with the help of a Velcro closure, using staples or various puncture buttons. Fig. 21b shows the jagged projections in the form of a puzzle (arrow 213). Thanks to the shape of the recesses, the ends of the ends can be joined together and do not have to protrude from above - as in a common puzzle.

权利要求:
Claims (15)
[0001]
1. ELASTIC JOINT SPACER, characterized by the spacer consisting, at least partially, of a material, specifically a polymer, elastomer or thermoplastic elastomer, with - Shore-A hardness level of 20-77 and tensile stress values in stretches between 20 and 60%, preferably 50%, above 3.8 N / mm2, preferably greater than 4.6 N / mm2 and even better, more than 6 N / mm2, and / or compressive stress values in compressions, between 20 % and 60%, preferably 50%, above 7.8 N / mm2, preferably greater than 9 N / mm2 and even better, more than 10.5 N / mm2, and / or - Shore-A hardness level up to 85 and tensile stress values in stretches between 20 and 60%, preferably 50%, above 6 N / mm2, preferably greater than 7 N / mm2 and even better, more than 8 N / mm2, and / or stress values compressive in compressions, between 20 and 60%, preferably 50%, more than 10.5 N / mm2, preferably above 12 N / mm2 and even better, more than 14 N / mm2.
[0002]
2. JOINT SPACER according to claim 1, characterized in that the material is a thermoplastic elastomer or elastomer and, preferably, consists of a class of polyurethanes and in which the thermoplastic elastomer or elastomer preferably contains exclusively polyisobutylene with a hydroxyl end and / or amine, and / or polybutadiene with hydroxyl end and / or amine, and preferably, hydrogenated polybutadiene with hydroxyl end as flexible segments.
[0003]
JOINT SPACER according to any one of claims 1 to 2, characterized in that the thermoplastic elastomer or elastomer contains, a) at least partially, polyisobutylene with an amine end as a flexible segment, and ethylenediamine and / or 1,4-diaminobutane, and / or even better, 1,6-Diaminohexane and / or 1,8-Diaminooctane as a chain extender, or b) at least partially, polyisobutylene with hydroxyl end as a flexible segment, and, at least partially, hexanediol, and / or , at least partially, butanediol as a chain extender in combination with the use of the catalyst 1,3-Diacetoxy-1,1,3,3-tetrabutildisestannoxane, or c) at least partially, polybutadiene with hydroxyl end and preferably hydrogenated polybutadiene with end hydroxyl as a flexible segment, and, at least partially, 2,2,4-Trimethyl-1,3-Pentanediol and / or 2-Butyl-2-Etyl-1,3-Propanediol, and / or, preferably N, N- Aniline diisopropanol and / or 2-Ethyl-1,3-Hexanediol as a c extender adeia.
[0004]
JOINT SPACER according to any one of claims 1 to 3, characterized in that the thermoplastic elastomer or elastomer contains, at least partially, polycarbonate diol and preferably types of polycarbonate diol copolymer as flexible segments.
[0005]
JOINT SPACER according to any one of claims 1 to 4, characterized in that the thermoplastic elastomer or elastomer contains at least one of the mixtures: 1. polyisobutylene and / or polybutadiene and polycarbonate diol as flexible segments and preferably the type of copolymer of polycarbonate diol with a proportion of polycarbonate diol in the total proportion of the flexible segment of up to 80%, preferably 5 to 40%, and 2. polydimethylsiloxane or polydimethylsiloxane polycaprolactone or polytetramethylene oxide block copolymers or a mixture of one or more of these flexible segments , in a proportion of one or more of these flexible segments in the total proportion of the flexible segment of up to 50%, preferably from 3 to 35%.
[0006]
JOINT SPACER according to any one of claims 1 to 5, characterized in that the polyurethane consists, at least partially, of Naphthalene-1,5-diisocyanate and / or paraphenylene diisocyanate and / or trans-1,4-diisocyanate cyclohexane and / or hexamethylene diisocyanate.
[0007]
JOINT SPACER according to any one of claims 1 to 6, characterized in that the polyurethane is cross-linked and the cross-linking reagent is preferably water or water combined with one or more chain extenders and / or cross-linking reagents.
[0008]
JOINT SPACER according to any one of claims 1 to 7, characterized in that the joint spacer contains at least one of: a) nanoadditives preferably designed in a disk or flat shape, and preferably has a width of 10 to 50 nm, preferably 25 to 30 nm, and thickness from 0.5 to 1.5 nm, preferably 1 nm, and b) at least partially, a porous structure with pore sizes between 0.1 nm and 2 μm, preferably between 1 and 500 nm, and even better, between 5 and 200 nm, and c) a nanofactory structure consisting of fibers with a diameter of 0.1 to 0.4 μm.
[0009]
JOINT SPACER according to any one of claims 1 to 8, characterized in that the spacer is configured as a meniscus spacer, the outer edge of which is positioned at a 90 ° interval, preferably at 45 °, is conveniently the same thickness or more thinner than the central area of the meniscus spacer, where the aforementioned areas are measured from the center of the contour of the circular edge.
[0010]
JOINT SPACER according to any one of claims 1 to 9, characterized in that, along its edge, this spacer consists, at least partially, of a layer of porous wool or of a porous tape or of a hose with thin fibrillar structure or on an additional fixing tape, preferably placed on the sleeve or under the tape, whereby the edge or, preferably, the porous edge layer of this spacer is preferably crossed or connected with visible markers for images, in the form of small pins , thin lines or wires or a ferromagnetic layer.
[0011]
11. JOINT SPACER according to any one of claims 1 to 10, characterized in that the spacer is configured as a knee spacer and the tape, hose or fixing tape can be connected to the remaining horns of the meniscus or in holes in the tibial plateau , or pass in a recess or on a profiled or C-shaped rail around the joint spacer or it is provided with latching elements, so that this spacer is detached from the fixing tape.
[0012]
JOINT SPACER according to any one of claims 1 to 11, characterized by one or more, preferably two projections arranged on the inner edge and which can be connected to the channel in the tibial plateau, adjusted to the shape or in a forced fit, preference, or by pin-shaped projections, which can be inserted into holes prepared in the channel configurations, in the tibial plateau.
[0013]
13. JOINT SPACER according to any one of claims 1 to 12, characterized in that the spacer is configured as a hip spacer and can be slid over the head of the femur in the form of an elastic cover, in the shape of a shell, by which it is preferable provision is made for an opening to implement the femoral head ligament.
[0014]
14. JOINT SPACER according to any one of claims 1 to 13, characterized in that a) hip spacer is separated from the opening to the edge of the shell-shaped cover, in which an overlap area is provided along the line divider, in which the outer part of the overlap area preferably consists of several buttons inserted in the respective recesses, at the bottom of that area, or b) hip spacer to be moved away from the proximal pole to the free edge, at least partially, preferably as a puzzle-shaped zipper.
[0015]
15. JOINT SPACER according to any one of claims 1 to 14, characterized in that a) the edge area of this spacer consists, at least partially, of a material with Shore-A hardness between 20 and 77 and the material of the central area (more rigid) has Shore-A hardness level above 77 with tensile stress values in stretches, between 20 and 60%, preferably 50%, above 3.8 N / mm2, preferably greater than 4.6 and better still more than 6 N / mm2, or b) the joint spacer has a layered structure, at least partially, with at least three layers, that is, at least two layers of cover and an intermediate central layer, made of different rigid materials, in which the difference in Shore-A hardness level between the covering layer and the central layer is greater than 5 and preferably between 10 and 20, and at least one of the layers is made of material with values of stretch tension, between 20 and 60%, preferably 50%, above 3.8 N / mm2, preferably greater than 4.6 N / mm2 and even better, more than 6 N / mm2 and / or compressive stress values in compressions, between 20 and 60%, convenient 50%, above 7.8 N / mm2, preferably greater than 9 N / mm2 and even better, more than 10.5 N / mm2.

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法律状态:
2019-08-06| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-06-09| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|

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2020-10-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-22| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/10/2014, OBSERVADAS AS CONDICOES LEGAIS. |

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