Device to be implanted in human or animal tissue and method for implanting and assembling the device

The invention is in the field of medical technology and relates to a device for implanting into a human or animal tissue, i.e. an implant or an endoprosthesis. The device includes two or more than two parts of the device that are adapted for in situ assembly, i.e. they can be joined during implantation at the implant site. The present invention further relates to a method of implanting and assembling the device in human or animal subjects, in particular implanting it into a bone tissue of a patient.

[0002] According to the state of the art, implants or endoprostheses consist of metallic, ceramic or polymeric materials. Some known implants or endoprostheses contain many parts that are assembled both when they are made either immediately before implantation and before being placed at the implant site (ex situ assembly). The parts e.g. consist of different materials and form regions of implants having different functions, such as those described in WO 2004/017857 or WO 2005/079696. The latter describes an implant containing e.g. both metallic and polymeric materials, wherein the metallic material assumes various functions, such as bone cutting and bone integration from a polymeric material, which serves after condensation and re-solidification to form a shaped joint that provides immediate primary stability of the implant implanted. The portions may be present in kits comprising a selection of shapes and sizes of parts, wherein the portions are selected and assembled immediately prior to implantation (ex situ) to fit the individual implantation site (described, for example, in US Pat. No. 5593425, Bonutti). In addition, it is known to determine the distal end at the proximal end of the implant or implant (assembly in situ), the distal portion then protruding from the tissue into which the implant or endoprosthesis is implanted (e.g., mounted in the crown on the dental implant or ball-mounted on the shaft of the joint prosthesis) hip). It is also known to provide implants or endoprosthesis, which are implanted in the tissue through further implants (eg, transverse pins for fixing the hearth to the endoprosthesis). Known in situ assemblies are usually based on a hole in one of the parts and a suitable pin, a cone or a screw, in the other part. Because the assembly indicated means the freedom that these assemblies can offer with respect to the detectable positions of the parts to be assembled and therefore their uses are very limited. In the above-mentioned publication US-5593425, it is suggested to assemble parts of the endoprosthesis, one of which contains a thermoplastic material, by heating the thermoplastic material and thereby making its sticky surface and bringing the heated and thus tacky surface into contact with the non-thermoplastic surface of another part of the prosthesis in order to attach it there.

[0003] It is an object of the present invention to provide a device for implantation in humans and animals, which device is an implant or endoprosthesis and comprise at least two parts to be assembled in situ. A further goal is to create a way to implant and mount the device. The device is more universally applicable than the known multi-part implants or prostheses for in situ assembly and allow greater flexibility with regard to the relative position of the assembled parts relative to each other, but still result in a strong connection between the parts of the implant or prosthesis.

[0004] This object is achieved with the device and the method according to the invention as claimed. [0005] If the following word invention is used and / or features are shown as optional, it should be interpreted in such a way that protection is required for the claimed invention.

[0006] The device according to the invention comprises two (or more than two) parts that are adapted to their assembly, i.e. joined together by means of mechanical oscillations, in particular ultrasonic vibrations, which are used for one of the parts in contact with the tool mechanically oscillating. . Parts of devices usually consist of plastic, but some of these parts may also consist of bone tissue. Each of the two parts of the device includes a connecting space, the two connecting points are mated to each other when in contact with each other when these parts are arranged for connection and to be connected to each other after the joining process, the resulting joint being a form-fit connection.

[0007] In order to achieve a molded fit, one of each matched pair of connecting sites contains a material with thermoplastic properties and is subject to condensation as a result of mechanical vibrations, which material constitutes a surface at the connecting point and can be pressed against this surface from within the part through application of mechanical vibrations. The second of each pair of matched connecting sites contains material that does not condense as a result of the mechanical vibrations used to connect the two parts of the device (like metal, ceramic or polymer with duroplastic or thermoplastic properties, but with a melting temperature that is respectively higher than the temperature melting of the liquefied material), and further comprising a structure suitable for a form-fitting fit with the material at the first connecting point when the material is condensed, made to penetrate the structure and re-solidify within this structure. The structure of the second connecting location comprises an undercut recess or projection or a plurality of undercut recesses or projections, wherein one or a relatively small number of recesses (e.g. holes or grooves) or projections of a predetermined shape and size preferably of several mm is provided and / or a large number of recesses or protrusions of random forms, i.e. formed by e.g. an open porous surface material or a surface coating consisting of composite particles (e.g. sintered material).

[0008] At least one of the portions of the device for connecting to each other further comprises a contact point, which is able to contact the vibrating tool (e.g. sonotrode of the ultrasound device) in the joining process. The part containing the contact location may include the first or second contact location.

[0009] At least a part of the device comprising a contact location and preferably both parts of the device are designed as mechanically stable oscillators, such that the mechanical vibrations applied to the contact point are transmitted by the oscillator to the connecting site with the least loss of damping, as possible in particular without reducing the mechanical stability of the oscillator during use so that it becomes possible to condense the material sufficiently (but not more) in the region of the connecting areas to achieve the desired shape fit, but without further altering the form or material of the device part. To achieve good properties of the oscillator, parts of the device are made of materials with a modulus of elasticity of at least about 0.5 GPa for low attenuation losses. The surface of each connecting point is preferably adapted to protruding energy directing elements (protruding pyramids, cones, ridges, etc., at least 10 mm high), which, using vibrations, locally concentrate vibration energies causing such high local shear stress and thus local and rapid liquefaction of the surface material, even if the melting point of this material is as high as 200 to 450 ° C. Thanks to such local liquefaction, the amount of material that is liquefied can be small (e.g. only sufficient to penetrate the structure of the second connecting site), and thus the thermal energy of the tissue remains physiologically (to allow functional tissue regeneration) even when macroscopic selections of the second site connection must be filled with liquefied material.

[0010] Depending on the form of the two connecting sites, the liquefied material may enable the relative positioning of the two elements of the device to be controlled during the joining process, which allows in situ alignment of the relative position of the two device elements to the implant site. Such greater in situ adaptation is possible if at least one of the connecting sites is constructed so as to allow the joining of two elements in a selected one of a number of different possible relative positions.

According to some aspects of the invention, at least one part of the device or both parts of the device are placed and optionally fixed in the tissue, both parts are placed relative to each other in such a way that their connecting sites touch each other and then mechanical vibrations are applied to each one of the parts for joining the two parts by condensation of the liquefiable material in the first connection point, allowing penetration into the recess or recesses or between and below the protrusion or projections at the second joining point and re-solidifying there. The mechanical vibrations used to connect the device parts, for example, have a frequency of from 2 to 200 kHz, and preferably ultrasonic vibrations.

[0012] Well-known methods are used to secure parts of the device to the tissue per se, such as, for example, screwing, clamping, pinning, bonding, sewing or pressing. According to preferred embodiments of the method according to the invention, the use of mechanical vibrations is used not only for connecting the two parts of the device to one another, but also for fixing one or both of these parts in the tissue by anchoring it in the tissue (in particular in the bone tissue) by means of condensation. material. Twice the use of mechanical vibrations can be performed simultaneously with the same contact place and the same vibration tool and / or one after the other and using different contact points and the same tool or different tools.

[0013] Devices for anchoring in tissue, in particular in bone tissue by means of condensable material and mechanical vibrations and methods for implanting such devices, are described in WO 2002/069817, WO 2004/017857 and WO 2005/079696.

[0014] Experiments show that an effective anchorage made at the same time as connecting is easily accomplished to the part of the device to which vibrations and anchors made prior to joining are used are more easily maintained when subsequent vibration in the joining process is not applied to the anchored part of the device. These discoveries are due to the fact that transmission of vibrations through the connecting joints is almost impossible, as the condensable material present where the two connecting sites are condensed substantially immediately after the use of vibrations, so that almost any vibration energy can be passed through connecting places. That is, outsidethe places connecting almost every condensation through mechanical vibrations appear, so neither anchoring in the tissue with the help of liquefying material and mechanical vibrations, or damage such as anchorage.

[0015] Herein, the term "liquefiable material" is used for the materials included in the device, which material can be condensed by mechanical vibrations, e.g. as a result of ultrasonic vibrations. If the condensable material is to take over the load-bearing functions and / or if only a small amount of it is to be condensed in the fixed places, the condensable material is a material in which mechanical vibrations do not cause intense internal stresses sufficiently to plasticize or condense the material, but on whose surface such condensation may be guided by contacting a vibration-free element, wherein such contacting is limited to points or lines (energy-directing elements). Such materials are materials with thermoplastic properties and a modulus of elasticity of at least 0.5 GPa. If the liquefiable material does not have a bearing function and / or if more materials are to be condensed by mechanical vibrations, the liquefiable material may be a material as described above, but it may also be a material with thermoplastic properties and with a lower modulus of elasticity.

[0016] In the present description, the term "non-condensed material" is used for the additional material contained in the device. In non-condensing material, mechanical vibrations, e.g. ultrasonic vibration, as used to condense a liquefiable material, do not cause internal stress that is sufficiently strong to condense the material nor are vibrations able to liquefy non-condensing material in surface areas when in contact with non-oscillating element, even if such contact is limited to individual points or lines (energy directing elements).

It follows from the foregoing that the properties of the non-condensable material of a particular device depend on the properties of the liquefiable material in the same device. Generally speaking, the lower the vibration energy is used to sufficiently condense the liquefiable material, the more condensed or non-condensed material can be condensed. Accordingly, a thermoplastic material with a high melting point (e.g. PEEK) is suitable for use as a non-condensable material when the liquefiable material is e.g. PLLA. On the other hand, the same thermoplastic material (e.g. PEEK) is suitable as a condensable material if the non-condensed material is, e.g., a titanium or ceramic material. [0018] In the present description, the term "mechanically stable oscillator" is used for a body that is able to vibrate e.g. by ultrasonic vibrations without exerting an internal influence by vibrations. A mechanically stable oscillator does not include a mold component that deforms due to vibrations that does not contain material with high loss of damping (e.g., a modulus of elasticity clearly below 0.5 GPa) and, if it contains more than one part, the parts are connected such that vibrations pass through the joint, essentially without loss or reflection.

[0019] Herein, the term "bone tissue" or "bone" is used to encompass not only living bone tissue but also bone substitute material.

[0020] According to the invention, the first device part forms a base in the bone tissue for the second part. The base portion is adapted for anchoring in bone tissue by means of condensable material and mechanical vibrations and preferably comprises a first connection point. The distal end of the second part of the device (the support part) is to be attached to the bone tissue through the base part and preferably has a second connection point. The base part is anchored in the bone tissue by means of mechanical vibrations, and the base part is attached to the part which is again supported by mechanical vibrations. Depending on the particular design of the base part and the base part, the anchoring of the base part in the bone tissue and joining the part based on it are carried out in two consecutive stages,

[0021] The corresponding liquefiable materials for joining parts of the device according to the invention are not biologically absorbable, whereas the liquefiable materials for anchoring parts of the device in the bone tissue can be either absorbable or non-absorbable. Suitable non-absorbable liquefiable materials for the first connection points and possibly also for anchoring parts of the device are, for example: polyolefins (e.g. polyethylene), polyacrylates, polymethacrylates, polycarbonates, polyamides, polyesters, polyurethanes, polysulphones, liquid crystal polymers (LCP), polyacetals, halogenated polymers, in particular halogenated polyolefins, polyphenylene sulphones, polysulphones, polyaryl ether ketones (e.g. PEEK polyether ether ketone, available under the trade name Victrex 450G or Peek Optima from Invibo), polyethers or corresponding copolymers and mixed polymers or composites containing the indicated polymers and fillers or reinforcing agents, such as, for example, fibers, whiskers, nanoplaques or nanotubes. Particularly preferred are polyamide 11 and polyamide 12.

Suitable absorbable liquefiable materials for anchoring parts of the device in bone tissue are e.g. thermoplastic polymers based on lactic acid and / or gluconic acid (PLA, PLLA, PGA, PLGA, etc.), or polyhydroxyalkanoates (PHA), polycaprolactones ( PCL), polysaccharides, polydioxanones (PD), polyanhydrides, polypeptides, trimethyl carbonates (TMCs), or corresponding copolymers or mixed polymers or composites containing the indicated polymers. Particularly suitable as absorbable liquefiable materials are: poly-LDL-lactide (e.g. available from Bohringer under the tradename Resomer LR708) or poly-DL-lactide (e.g. available from Bohringer under the trade name Resomer R208) as well as suitable copolymers and mixed polymers or composites containing the indicated polymers and fillers or reinforcing agents,

[0024] The device according to the invention serves the same purpose as the known implants and endoprostheses. The device serves in particular for securing one vital part of the tissue to another vital part of the tissue, wherein the device according to the invention is a fixing element, in particular a load bearing fastening element between two parts of the tissue. The device may also serve to attach an artificial element replacing the natural part of the tissue or an accessory (e.g., an auxiliary support part), the device according to the invention being a spare part or an additional part as well as fixing means.

[0025] An advantage of the device according to the invention and of the method is in situ assembly, robustness of assembly, a mounting form that makes it irreversible under physiological conditions and an easily and little-limited in-situ assembly capability.

In order to carry out the method, a vibrating device is used, for example an ultrasonic device comprising an ultrasonic transducer, amplifier and sonotrode or sonotrode (vibrating tool) and an acoustic coupling element (vibrating tool), wherein the sonotrode or coupling element is preferably interchangeable. Preferably, a kit is provided that includes, in addition to the device part, vibrating tools with distal ends adapted to the connecting points of the device parts and proximal ends adapted to the attachment point of the vibrating device or sonotrode, respectively. Kits may also include printed or otherwise stored instructions regarding implantation parameters,

[0027] Exemplary embodiments of the method and apparatus of the invention are described in more detail with reference to the following drawings, in which:

Figs. 1 to 7 show the structures of second connecting sites and joints achieved by connecting matching pairs of connecting sites;

Figs. 8 to 14 illustrate a first group of embodiments of the invention in which the distal end of the support portion is fixed in bone tissue by means of a base portion, the base portion being anchored within the opening in the bone tissue, wherein the base portion is fixed in the bone tissue. or on the base part, wherein the based part has different functions;

Figs. 15 and 16 illustrate a second group of embodiments of the invention, wherein the group is similar to the first group, but in which the base portion is anchored in the marrow space in a suitably prepared tubular bone; and

Figs. 17 to 20 show a third group of embodiments of the invention, wherein the base portion is connected to a proximal end of the base portion which protrudes from an opening that is placed in the bone tissue in which the base portion is anchored.

[0028] Figures 1 to 7 show embodiments of matched pairs of first and second connecting locations suitable for devices according to the invention, and connections between such connecting points. The first connection point F comprises a condensable material and optionally energy directing elements E, the second connecting place S comprises an undercut structure of non-condensable material and possibly energy directing elements E. For connecting the two matching connecting points, they are pressed against each other and the mechanical vibrations are coupled in one of the parts, comprising either the first or the second connecting place from the side opposite to the connecting point. Pressure and vibration cause the condensable material in the region of the energy directing elements to condense and penetrate in the liquid state into the structure of the second connecting point,

The main function of joining the two parts of the device comprising the matched pair of first and second connecting points using mechanical vibrations is that the material conducive to the first connecting site is liquefied and liquefied in the structure of the second connecting site, which is usually undercut liquid flow. The obtained matched structures of the condensable material are characterized by forms that depend on the surface tension in the liquid state. The condensable material of these structures may adhere to the material of the second connecting site, but there is no need for it.

[0030] Figs. 1 to 3 show as a first example a second connecting site S a foam structure consisting of a metal, for example titanium. Fig. 1 shows the foam structure before it penetrates the condensable material, Fig. 3 shows the peg of the condensable material anchored in the foam structure, and Fig. 2 shows, on a larger scale, the penetration of the foam structure by the condensable material after re-solidification, i.e. shape connection fitted between them. This form-fitting fit that is visible in Figs. 2 and 3 includes in this example first structure elements with a size in the range of about 1 mm or less. A first connecting location adapted to the connecting location, as shown in Figs. 1 to 3, comprising a condensable material, is adapted to the outer surface of the foam material (e.g., equal) and is large enough to cover a plurality of structure elements. The structure elements for the foam structure are able to act as a plurality of energy-directing elements, so that the first connecting point does not have to be adapted to the energy-directing elements. However, the first connection point can also be formed by a more or less sharp distal end of the pin-shaped device part, which sharpened end acts as an energy conductor.

[0031] Fig. 4 shows in the cascade three scales of a second example of a second connecting place and a shaped connection adapted between this second connecting location and the first connecting location. The illustrated second connecting location is formed by the surface of the hip joint prosthesis by S + G Implants GmbH, Lübeck, Germany. The surface structure of the implants consists of metal (preferably titanium or titanium alloy) and is for example made by sintering a particulate material or by lost mold formation. The structure elements have an average size of from about 1 mm to about 2 mm. The first connecting location adapted to the second joining location according to Fig. 4 consists of a condensable material and is adapted to cover a plurality of structure elements, as discussed for the connecting elements according to Figs. 1 to 3.

[0032] Similar structures as shown in Fig. 4 as suitable for the second joining points may be made of a Zimmer-shaped metal or mesh-like metal as known with Johnson & Johnson implants. Eska implants should also have appropriate surfaces.

[0033] Fig. 5 shows the second connecting places S comprising a more or less regular pattern of undercuts (e.g. openings or grooves) that are produced or molded. In the second connecting position S on the left, the outlet of the undercut holes protrude somewhat from the overall surface and thus are able to act as energy directing elements. The matched first connection point F can be completely equal. The structure of the second connecting site S to the left in Fig. 5 does not include energy directing elements, and therefore the energy directing elements E are preferably arranged at the first connecting location. The structures of the second joining site of Fig. 5 preferably have a size of about 1 to a few millimeters, and the first connecting site includes a plurality of them.

[0034] Fig. 6 shows a matched pair of connecting places F and S similar to the joining locations according to Fig. 5, wherein the structure of the second connection point comprises undercuts (e.g., heads or combs with a narrow neck area) instead of holes. These projections, if adapted to more or less sharp edges or points, also act as energy directing elements.

[0035] Fig. 7 shows a last example of a matched pair of connecting sites, wherein the structure of the second connecting site S, which again constitutes an undercut hole, is larger than in the first connection position F. The first connecting location is at the distal end of the pin-shaped part, which pin-shaped part is inserted into the hole when the parts to be joined are pressed against each other. The distal end of the pin is e.g. designated as being able to act as an energy directing element and the pin comprises a sufficient amount of material condensed to fill the undercut hole constituting the second connecting place.

[0036] Figs. 8 to 14 show a first group of embodiments of the invention and their uses. The device is an implant or an endoprosthesis and includes a base part (first device part) and a base part (second device part), the resting part based in bone tissue through the base part by connecting it to the base part. The basic part is adapted to fit in the hole made in bone tissue and is adapted to be anchored in this opening with the help of the first material that undergoes condensation and mechanical vibration. For this purpose, it contains a material that is condensed at least in the surface areas, to contact the bone tissue or the liquefiable material is placed inside the base part and for anchoring it is pressed through the openings to the surfaces in contact with the bone tissue. The base portion further preferably has, on its proximal side, one of the connecting points, preferably the first connection point. The support portion includes a distal end adapted to be connected to the base portion and including one of the connecting points, preferably a second connecting location.

[0037] Fig. 8 shows an anchor for e.g. anchoring a seam 21 or a wire or other flexible part of the device relative to bone tissue. The anchor comprises a base part 1 (first device part) held in the bone tissue opening and a supported portion 2 (second device part) whose distal end is adapted to be held in the base portion 1 and whose proximal end is adapted to retain a suture or wire (further part devices). The base part 1 is adapted to being anchored in hard tissue, in particular bone tissue, with the aid of a condensable material and mechanical vibration, and comprises a first connection point 3. At least a part of the outer surface of the base part 1 comprises a condensable material and possibly energy guiding means in the form of ribs or other projections. The proximal surface of the base part is suitable for contacting the vibrating tool (contact point 4 for the application of mechanical vibrations for anchoring the base part in bone tissue). The base part 1 further comprises an opening 5 extending from its proximal end face towards the distal end, the inner surface of the opening 5 comprising a condensable material and possibly energy directing means (first connection point 3). The base part 1 consists e.g. of a completely of a liquefiable material, e.g. a thermoplastic polymer. The base part 1 further comprises an opening 5 extending from its proximal end face towards the distal end, the inner surface of the opening 5 comprising a condensable material and possibly energy directing means (first connection point 3). The base part 1 consists e.g. of a completely of a liquefiable material, e.g. a thermoplastic polymer. The base part 1 further comprises an opening 5 extending from its proximal end face towards the distal end, the inner surface of the opening 5 comprising a condensable material and possibly energy directing means (first connection point 3). The base part 1 consists e.g. of a completely of a liquefiable material, e.g. a thermoplastic polymer.

The support part 2 comprises, at its distal end, a second connecting place 6 (e.g. according to any of Figs. 1 to 6) and at its proximal end a contact point 7 for the application of mechanical vibrations to the joining process. The base part 2 is e.g. made of a suitable metallic material and its distal end is fitted to the opening 5 of the base part 1. The second connecting place 6 comprises e.g. undercut recesses and possibly energy directing means (e.g., axial ribs).

[0039] For implantation and assembly, the device comprising the base part 1, the base part 2 and possibly the seam 21 or the wire, the base part 1 is e.g. placed in an opening 10 placed in the bone tissue 11 and a vibrating tool 12 (vibrating tool for the anchoring process, e.g. sonotrode of the ultrasonic device) from the distal face is adapted to the proximal face (contact point 4) of the base part 1 is pressed against the proximal face. Caused by vibration and pressure, the condensable material in contact with the bone tissue is condensed and penetrates into the porous structure of the bone tissue to create the desired anchoring of the base part 1 after re-solidification. Due to the high modulus of elasticity of the material of the basic part and because of the energy directing elements,

[0040] When the base part 1 is anchored in the bone tissue 11, at least the distal end of the support part 2 is inserted into the opening 5 of the base part and a further vibrating tool 15 (vibrating tool for the joining process) with the distal face being adapted to the contact point 7 based part 2 is applied to the based part. The use of mechanical vibrations 1 condenses the liquefiable material of the first connection point 3 in the opening 5 of the base part and makes it fill the undercut recesses located in the second connecting point 6 to form a shaped connection fitted with the first connection point 3 of the base part and thereby connecting the support part 2 to the base part 1.

[0041] The base portion 2 may have various functions that differ from the functions shown in Fig. 8 (suture or wire anchor) for which functions the proximal end of the support portion is suitably adapted. Exemplary further functions of the support portion 2 are the attachment of soft or even hard tissue to the bone tissue, rod fixation, rod clamp used in the vertebral fusion or external fixation, a carrier plate used for osteosynthesis or other anchoring aids, e.g. a tracking device. For such fastening purposes, the proximal end of the support portion 2 can be adapted, for example, to an external or internal thread. The base part 1 and the support part 2 together may also be an implant to which a further part of the denture is to be attached.

[0042] The main advantage of the two-part device according to Fig. 8 compared to a corresponding one-piece implant anchored in bone tissue with the aid of condensable material and mechanical vibration is that the based part has at least a limited regulation when the base part is finally fixed. in bone tissue. The condensation of the material surrounding the aperture 5 allows the portion to be pushed into position and orientation relative to the base portion, which may not exactly correspond to the original aperture 5. In addition, the circular or polygonal cross-sectional shape of the aperture 5 and the distal end of the rebosable portion 2 allow one to choose the right one. from a plurality of possible rotational positions of the portion based on the base part. A further advantage of the embodiment according to Fig. 8 is that

[0043] The apparatus and method as shown in Fig. 8 can be varied in various ways, giving, for example, the following further embodiments:

The base part comprises a core made of a non-condensable material, which core has a condensed material for anchoring the base portion in the bone tissue to the eggs of the outer surface and which core contains an opening constituting the second connecting place (the core material is e.g. a sintered material present, in the opening 5 of the porous surface into which the material conducive to the first bonding spot, the pair of matching connecting sites according to e.g. Fig. 4), and the support part comprise at least in its distal end this condensable material constituting the first connection point (see also FIG. 9).

• the base part is made of non-condensable material and includes channels connecting the opening 5 with the outer surface and the condensable material is placed in the opening 5. For anchoring the base part in the bone tissue, mechanical vibration and pressure are applied to the material condensed in the hole 5 for partially pressing it through the channels and in the bone tissue, the condensable material remaining in the opening 5 is the first connecting site (see Fig. 11).

• the base part consists entirely of non-condensable material and is fixed in the bone tissue, e.g. by the contained thread and by screwing in the bone tissue. The base part is adapted to a second connecting place (e.g. according to Fig. 7) and the base portion is adapted to the first connecting point. • Instead of the opening 5, the base part includes a proximal projection corresponding to the opening in the support part where the connecting locations are arranged (see Fig. 14).

[0044] Fig. 9 shows a further embodiment of the invention. The device is suitable for implantation and assembly in a manner as shown in Fig. 1. The base portion 1 comprises a core 22 of non-condensable material, which core 22 has on the outer surface a condensable material for anchoring the base portion 1 in bone tissue, and further comprising an opening 5 extending from the proximal end face towards the distal end of the base portion and constituting a second connection place (according to Fig. 7). This opening 5 is a hole with an enlarged area of ​​the bottom serving as an undercutting recess for a form fit mating with the support part 2 but also for snapping-in the portion based before the joining process.

[0045] Two versions 2.1 and 2.2 of the support part are shown, both versions consisting of a liquefiable material and comprising a distal end adapted to be latched into the widened lower area of ​​the opening 5. Version 2.1 of the support portion comprises a groove 25 extending through its further face and optionally has it along the side surface of the part based on its proximal surface. The groove 25 is shaped to be able to guide the seam 21, such that when the reed portion 2 is snap-fitted to the base portion 1, the seam 21 can be moved along the groove e.g. to be clamped. On joining the support part 2.1 to the base part 1, the material around the groove 25 is condensed and, when the support part is re-solidified, it is connected to the basic parts, and at the same time,

[0046] The version 2.2 of the support portion comprises a seam 21 attached to it, for example by placing in a mold in which the supported part is produced by injection molding. In order to be able to adjust the position of the seam 21 in relation to the anchored base part 1, the support part 2.1 or 2.2 has, for example, a circular cross section and can be rotated in the opening 5 when it is snapped in it.

[0047] Fig. 10 further shows a further embodiment of the invention. The illustrated device again serves as the suture anchor and again includes the base part 1 and the support part 2 and is implanted according to the method as shown in Fig. 8. The base part 2 and the base part 1 are adapted to each other such that the support part 2 can be snap-fitted in opening 5 of base part 1 on at least two different depths. The first end of the seam 21 is e.g. fastened in the support portion 2 and the other end of the seam 21 is threaded e.g. by soft tissue 27 and then through openings 28 and 29 extending through the base part 1 and the support part 2 and aligned with each other when the support part it is snapped into the base part in its outermost position. When the other end of the seam is attached in the correct position, the tension of the seam can be increased by pressing the supported part 2 into a deeper snap-in position. The support part 2 together with the seam 21 is then secured to the base part by applying mechanical vibration to the proximal face of the resting part 2.

[0048] Fig. 11 further shows the use of the device according to the invention. The device is e.g. used to attach soft tissue (e.g., ligament or tendon 31) to bone tissue 11 in which the base portion 2 is attached by the base part 1.

[0049] The base part 1 comprises a perforated sleeve 1.1 comprising on its inner surface the energy directing means and consisting of the non-condensable material and the insert 1.2 of the condensable material which is placed in the tube 1.1. The sleeve is placed in the opening 10 which is placed in the bone tissue 11 and is pressed into the sleeve and vibrated by the first vibrating tool 12 placed against the proximal face of the insert 1.2. The insert material is thereby condensed and pressed through the openings of the sleeve into the bone tissue 11 of the wall opening 10 anchoring the base part 1 in the bone tissue. The rest of the insert in the sleeve is the first connecting place. [0050] The support portion 2 consists of a non-condensable material and comprises a head 30 for retaining in the tendon or ligament 31 through which the distal end of the support portion 2 is pushed before joining to the base part. The distal end of the support portion is the second connecting place by including the head, which is preferably sharp (energy directing element). To connect the part based on the base part, another vibrating tool 15 or the same (12) as for anchoring is placed on the head 30.

[0051] Fig. 12 shows schematically a further device according to the invention, which device is used for fastening e.g. a ligament or tendon 31 to the bone tissue. The device is adapted similar to the devices as shown in Figs. 8, 9 or 11. Other than in the figures mentioned. However, the base part 1 of the device according to Fig. 12 is able to accommodate more than one supported part 2 of which only one is illustrated. The base portion 1 can have any suitable form, e.g. substantially round or substantially rectangular. The base portion 2 shown in Fig. 12 includes spikes that are able to pre-hold the support portion 2 in a corresponding opening 5. This is advantageous, to firstly place and pre-hold all the parts based in their respective openings 5 ​​in the anchored base part 1 and only then to finally connect all the parts based on the base part 1 with mechanical vibrations applied to the head 30 of each supported part. The spikes may also be the structure of the second connecting location (second connecting location according to Fig. 6).

[0052] Fig. 13 shows a device according to the invention in which the support part 2 is a seam 21 and which allows anchoring of the basic part 1 in the shape of a pin and joining the base part 1 and the seam 21 (the support part 2) simultaneously. The base part e.g. consists of a condensable material and the areas in which it is anchored in the bone tissue are substantially the same as the first connection points, i.e. the lateral surfaces of the base part. The seam 21 consists of a non-condensable material. It is wound and possibly tied around the base part 1 on which the groove can be placed on the base part, in particular for guiding the seam from the side sides of the base part to the proximal face (groove 32).

[0053] Fig. 14 further illustrates the use of two parts of the implantation device e.g. according to the method as shown in Fig. 8. The application relates to the discovery of the bone surface or the surface of the cartilage constituting the bearing surface in a joint. Fig. 14 shows the discovery of the surface of the femoral head, but it may apply in the same way to a bowl-shaped structure. Such implants primarily replace the damaged layers of cartilage, but try to leave most of the basic bone structure. Comparable methods can be applied to almost all joints in the human skeleton, convex, concave, flat or with the geometry of many curves.

[0054] Fig. 14 also shows an embodiment of the invention in which the base part 1 does not include an opening for the distal end of the support part 2, but in which the base part 1 comprises a projection 39 and the support part 2 comprises an aperture 41 adapted to the projection (also possible: hole on the base part and protrusion on the base part). This principle may be adapted as a variant in other embodiments of the invention as described above. In addition, in Fig. 14 there is shown a base part 1 which is not fixed in one opening in bone tissue, but in a plurality of such openings, which many orifices may be rather small (e.g. two, as shown) or very large, means formed by the natural or produced roughness of the bone surface (e.g., the surface of the spongy bone).

[0055] In the device according to Fig. 14, the base part 1 is anchored in a plurality of holes of a suitably prepared femur. The base part 1 comprises a plurality of further projections which comprise a condensable material and which penetrate into the dry bone cavities and are anchored therein by means of a condensable material and mechanical vibration. The proximal side of the base part is e.g. made of metal, ceramics or non-condensed polymeric material and comprises a proximal projection 39 comprising a surface structure with undercut recesses (second connection place). The base part 2 comprises interchangeable bushings (40) and an opening 41 on the opposite surface of the shell, in which the material condensing the first connection point is placed.

[0056] Figs. 15 and 16 illustrate a second group of embodiments of the invention. These embodiments differ from the embodiments described above from the first group in that the opening in the bone tissue in which the base portion 1 of the device is anchored is not an opening that is made in the bone tissue but the space of the tubular bone 45. The device is e.g. an endoprosthesis replacing part of the joint.

[0057] Fig. 15 shows a substantially hollow base part 1 made of eg a liquefiable material (also possible: comprising a core of non-condensable material covered at least partially with a liquefiable material) and designed to be anchored not only inside the bone surface of a tubular bone 45 but also on its face formed by removing one end of the tubular bone section 45 to be replaced by the device. Part of the replacement bone is e.g. part of a smaller joint (e.g., a finger joint). The proximal end of the support portion 2 represents the majority of the exchange and the distal end is intended to fit into the base part 1 and constitutes the second connecting place (for example according to one of Figs. 1 to 3, 4, 5 or 6).

[0058] Fig. 16 shows a device according to the invention being a hip prosthesis, wherein the base part 1 is the backbone of the prosthesis to be anchored in the femur and the support portion 2 is the intermediate part of the prosthesis to which the second part 2 '(based on the support part 2 which is itself based on the base part 1 and forms part of the prosthesis ball). The connecting points between the base part 1 and the support part 2 and between the support part 2 and the second support part 2 'are shown without details. However, each of the matching pairs of connecting locations includes a first and a second connecting place and is adapted, to create, after use of a mechanical vibration, a positive fit between the respective surface of the material structure of the non-condensable second bonding spot and the condensable first bonding material having a liquid state in the surface structure. The preferred second of the connecting locations for the device of Fig. 16 are in particular structures as shown in Fig. 4, however, the structures of Figs. 1 to 3 or 5 or 6 are also used. It is also possible that all three or at least two of the prosthesis parts 1, 2 and 2 'of Fig. 16 are connected immediately before implantation, i.e. by the surgeon in sterile space, and that the assembled prosthesis is anchored in one part in space bone marrow.

[0060] Figures 17 to 20 show embodiments of a third group in the embodiments of the invention. In this group of embodiments, the base portion 2 is connected to the proximal end of at least one base portion 1, the proximal end protruding from an opening in the bone tissue in which the base part 1 is anchored and wherein the mounting of the base part 1 and the support part 2 serves for securing another tissue (e.g., soft tissue) or a further part of the device and wherein the further tissue or part of the device is attached to the bone tissue in which the base part 1 is anchored by mounting the base portion of the proximal end and the support portion 2. Instead of the named attachment function, the support part may also serve to reinforce and stiffen the base part (Fig. 20).

[0061] Fig. 17 shows an apparatus and a corresponding implantation method that serve to attach a portion of soft tissue (e.g., tendon or ligament 31), or to a distal portion of the device (e.g., a carrier plate used for osteosynthesis) against bones. The base part 1 is, for example, in the shape of a pin and consists of a condensable material. It is anchored in the opening 10 in the bone tissue 11 by means of a condensable material and mechanical vibration, so that its proximal end, which is for example pointed, protrudes from the opening 10. The tendon or ligament 31 is then pressed against the proximal end of the base part 1 so that the proximal end passes through the ligament or tendon 31, which is either pre-perforated or not. The base part 2, which is made as a kind of head on the base part 1, and on its further side, has a second connecting place (preferably according to Fig. 7, the sharpened distal end of the base part serves as an energy driver) is then placed on and connected to the proximal end of the base part 1 using mechanical vibration to the head-shaped head part 2. As shown in Fig. 17, the outer periphery of the head-shaped head portion 2 may include protruding sharp edges that, in joining the base portion 2 in the base portion 1, are pressed against the tendon or ligament 31 and serve as additional means for retaining the tendon or ligament 31 in relation to bone tissue 11 in which the base part 1 is anchored. it comprises a second connecting location (preferably according to Fig. 7, the sharpened distal end of the base part serves as an energy directing element) is then placed on and connected to the proximal end of the base part 1 using mechanical vibration to the head-shaped head portion 2. As shown in Fig. 17, the outer periphery of the head-shaped head portion 2 may include protruding sharp edges that, in joining the base portion 2 in the base portion 1, are pressed against the tendon or ligament 31 and serve as additional means for retaining the tendon or ligament 31 in relation to bone tissue 11 in which the base part 1 is anchored. it comprises a second connecting location (preferably according to Fig. 7, the sharpened distal end of the base part serves as an energy directing element) is then placed on and connected to the proximal end of the base part 1 using mechanical vibration to the head-shaped head portion 2. As shown in Fig. 17, the outer periphery of the head-shaped head portion 2 may include protruding sharp edges that, in joining the base portion 2 in the base portion 1, are pressed against the tendon or ligament 31 and serve as additional means for retaining the tendon or ligament 31 in relation to bone tissue 11 in which the base part 1 is anchored. using mechanical vibrations to the head-shaped head part 2. As shown in Fig. 17, the outer periphery of the head-shaped head portion 2 may include protruding sharp edges that, in joining the base portion 2 in the base portion 1, are pressed against the tendon or ligament 31 and serve as additional means for retaining the tendon or ligament 31 in relation to bone tissue 11 in which the base part 1 is anchored. using mechanical vibrations to the head-shaped head part 2. As shown in Fig. 17, the outer periphery of the head-shaped head portion 2 may include protruding sharp edges that, in joining the base portion 2 in the base portion 1, are pressed against the tendon or ligament 31 and serve as additional means for retaining the tendon or ligament 31 in relation to bone tissue 11 in which the base part 1 is anchored.

[0062] Fig. 18 shows the same method and like parts of the device as in Fig. 16 for securing an intervertebral element 50 (hereafter part of the device), e.g. an intervertebral fusion member or cage, for attaching two adjacent vertebral bodies to each other and to securing between two adjacent vertebral bodies 51. The placed intervertebral element 50 is shown from the side. It is positioned between the stems 51 and then two or more than two of the pin-shaped base parts 1 are anchored in the spinal cords above and below the intervertebral element 50. The substantially rod-shaped or plate-shaped support portion 2 is then attached to the ends of the proximal base portion. and moves towards the intervertebral element 50 forming together with the base part 1, a clasp,

The base plate is preferably thin and in particular flexible in all directions. The support part 2 is made of a plurality of stiffening elements 57 to be connected to one side of the base plate 55 directed away from the bone surface (proximal side). Either the base plate 55 or the stiffening elements 57 comprise a first connection point (e.g., base plate 55), another second connecting place (e.g., stiffening elements 57), which is e.g. made according to Fig. 6 but can also be constructed according to any of the Figs. 1 to 3, 4 or 5.

[0065] The flexible base plate is implanted e.g. on the entire bone fracture and flexibly adapted to the shape of the surface of the respective bone. The implanted base plate is then stiffened preferably only locally, depending on the required stabilization of the fracture by appropriately shaped and placed stiffening elements 57 (e.g. parallel strips stiffening at a distance from each other, transversely placed strips or stiffening stiffening plates). Preferably, the stiffening elements are also elastic and only the connection between the base plate and the stiffening element has the stiffness required to stabilize the fracture. It may furthermore be preferred that the base plate is of absorbable material such that stabilization must be taken over by the bones gradually,

[0066] Another or additional advantage that can be achieved in the assembly as shown in Fig. 20 is that the mandrels 56 and the holes thus made in the base plate 55 can be covered by stiffening elements 57. This is particularly advantageous when the assembly serves to replace the bearing surface of the joint, e.g. a joint shell and one plate is used as a stiffening element.

[0067] It is obvious to a person skilled in the art that the features described above and shown in the embodiments of the invention are combined in a variety of ways and thus to form further embodiments that will still fall within the scope of the invention.

Woodwelding AG, Switzerland Plenipotentiary:

EP 2 389 883 B1-15094/16