PT1363543E - Implants and device for joining tissue parts - Google Patents

Description

Description " IMPLANTS AND DEVICE FOR CONNECTING TISSUE AREAS " The invention relates to an implant according to the generic concept of the first independent claim of the present invention. The implant serves to make connections which at least in part provide a perfect fit with areas of human or animal tissue, in particular with skeletal parts, with the aid of implants being the connection between areas of tissue or areas of tissue with elements for example, supporting or replacing tissue areas, or other therapeutic aids. Furthermore the invention relates to a device according to the generic concept of the respective patent-independent claim. The device and method serve to implant said implants.

Implants already known to make connections with skeletal parts (bones) are for example screws, spikes, staples, etc., with which bones are bonded with bones or bones with artificial parts, which are supporting, stabilizing, supporting or being (stabilizing or fixing plates, wires, metal wires, artificial articulation elements, artificial teeth, etc.). Such connecting elements to be implanted are for example made of metal or synthetic material, but also of resorbable synthetic material. After healing these elements are, if necessary, removed again by means of a surgical intervention, but may also remain in the body, where in certain cases they are gradually decomposed and replaced by vital tissue.

For the stabilization of a bone fracture, it is fixed in the fracture zone, by means of the aforementioned screws, for example a fixing plate provided with suitable holes. For this purpose the plate and the screws are made for example of metal (for example of stainless steel or titanium). The screws are self-tapping and screwed into threadless holes, which are opened in the bone or are screwed into previously opened threaded holes. For similar purposes spikes and staples are also inserted into previously opened holes. The connections thus obtained generally provide a grip attachment and eventually a perfect fit as well.

In all cases, it is necessary to use relatively large forces (torsional forces and percussion forces) when using the aforementioned connecting elements, these forces being again exerted on implants of the aforementioned kind which must be retracted, and during its removal. This means in many cases that the implants must have a higher mechanical stability, which can support not only implantation but also, as the case may be, removal, than those implants have to support in the implanted state. In particular, in the case of implants made of resorbable synthetic materials, which have a considerably lower mechanical resistance than that of metals, this causes the implants to have relatively large cross-sections, which is why it is also necessary to open quite large holes in the implant. vital tissue, which is undesirable. The mechanical placement of the implants during which it is necessary to overcome, for example, the friction that produces the adhesion bonding, is also associated with the development of considerable amounts of heat affecting the surrounding tissues, namely when opening threads, to screw self-tapping screws and to pry implants without previous drilling. In order to carry out the aforementioned connections plastic materials are also known which are curable (for example cements with particles dispersed in a hydraulic base or polymer), which in a highly viscous state are injected under pressure from the exterior between the implant and the vital tissue or in lesions of the tissue and that solidify in situ. In this way, connections with perfect fit are also possible, but only if the holes into which these materials are pressed have suitable recesses.

From the publication under the number US-3919775 it has further become known a method of introducing into the root canal of a tooth a sealing bush, which is made of gutta-percha, in order to seal that channel. The bushing is pressed into the channel with the aid of an instrument, which instrument is, if necessary, electrically heated or sonicated to further soften the bushing, so that the bushing can be pressed as far as possible entirely into of the root canal or into the lateral channels.

In view of the foregoing, the object of the invention is to create implants for perfectly fitting connections with tissue areas (in particular with bone parts, parts of cartilage, parts of ligaments, parts of tendons or also with other areas of tissue ), implants that can be implanted in a simple way, applying reduced forces and in a fast way and that allow to provide immediately of very good quality bonds (primary stability). In addition it would be desirable for the implants to have fewer problems with regard to the amounts of heat produced and the concentration of stresses than is the case in at least a part of the already known implants, and even though it was possible to further reduce the volume of the material strange to implant. Furthermore, the aim of the invention is to create a device and a process that allow implantation of implants.

These objects are attained by the adoption of implants and the device defined in the claims of the present patent. The invention makes use of the fact already known per se, for example from the publication number WO-98/42988, that in particular thermoplastic polymer materials can be liquefied in a controlled manner by the application of mechanical pulses and can in this state be injected under pressure, by means of a hydrostatic pressure, into cavities (for example wooden pores), which causes that after the solidification, perfectly fitted connections are created.

According to the invention, the implants which serve to make perfectly fitting connections with respect to tissue areas are therefore at least partially composed of a material which can be driven by mechanical energy at relatively low temperatures (< 250 ° C) (ie ultrasound), that is to say by means of internal and / or external friction, to a liquefied state such that under the effect of an external pressure it can be pressed into pores and other holes in an area of fabric where, again solidified, this material provides a perfectly fitting connection.

In order to serve as liquefiable materials by the application of mechanical energy to the implants according to the invention, in particular polymers which become plastic at relatively low temperatures, in particular thermoplastics already used in medicine, such as polyethylene (PE) (PLA, PLLA, PGA, PGA, PLAA, PLAA, PLAA, PLAA, PLAA, PLAA and PLAA) PLGA, etc.), as well as polyhydroxyalkanoates (PHA), polycaprolactones (PCLs), polysaccharides, polydioxanes (PD), polyanhydrides or the corresponding copolymers. Equally suitable are the already known hydraulic cements or polymers, which have thixotropic properties, such as calcium phosphate, calcium sulphate or methacrylate cements, which may also contain materials prepared in a thixotropic manner, fabrics belonging to the same body or transplanted. Thanks to their thixotropic properties, such cements can be brought by the application of mechanical energy, namely ultrasonic, from a highly viscous state to a liquid state without increasing the temperature.

For implantation an implant according to the invention is brought into contact with the tissue area (on the surface or in a cavity possibly opened specifically for the implant) and then subjected to the action for example of ultrasound energy, while simultaneously depressing against the tissue area. By appropriate molding of the implant and through a corresponding dosing of the energy it can be achieved that the liquidisable material is only effectively liquefied to the minimum degree required at the application site. When it has been liquefied and injected at a sufficient amount of material pressure, the energy is discontinued so that the liquefied material solidifies in the shape thereof, and the pressure exerted on the implant .

For the purposes of implantation, the materials referred to are not liquefied by external heat, but by means of mechanical energy (pulsed energy, vibratory energy) due to internal and / or external friction. During this operation the thermal demands on surrounding tissues remain low. The mechanical energy causes a high shear effect to be achieved between the various phases of material. This contributes to the liquefying materials being uniformly liquefied without greatly affecting neighboring tissues and achieving a low viscosity. The thus liquefied material is then depressed by hydrostatic pressure into the pores and cavities of the surrounding tissues. In this way it becomes possible to impregnate the surrounding tissues, reinforcing them by the use of this hydrostatic effect.

If necessary, it will be advantageous to add to the liquefiable material supplementary substances which provide other functions, for example for substances which mechanically reinforce the material, which in a second reaction cause the material to increase in volume and form pores in it, as well as substances which are released into the vital surroundings in order to foster a healing or a regeneration or substances which must assume other functions. To serve as substances which promote healing or regeneration, it is possible in addition to the material for example growth factors, antibiotics or anti-inflammatories, such that these substances can be brought with the flow of material to a desired point or else distributed in a region of the fabric or, in the case of a resorbable material, be released with delay.

With the connecting implants according to the invention it becomes possible to obtain more punctual connections or connections on a large surface. By virtue of this it is possible to influence and guide in a controlled manner the distribution of loads. Thus, for example, it is possible to fasten on a large surface, by means of the implants according to the invention, fixation or stabilization plates on a bone surface (see for example figures 15 or 16) or more localized and with depth effect (see Figures 2 to 4). Surface connections are obtained, for example, by placing plates or other supporting or fixing devices which integrate liquidisable zones or which contain entire liquefaction layers in the places to be connected, these sites being then excited at least locally to be liquefied by the application of mechanical energy (for example vibration by ultrasound). Advantageously, the blender zones are equipped with energy directing guides or are in contact with such guides. These energy guidance guides support local liquefaction. As far as the energy directing guides are concerned, they may be protruding elements, for example in the form of pyramids, cones, hemispheres or ribs, and which cause a concentration of the applied mechanical energy. 7

Depth anchorages are obtained by causing the implants, which have for example the shape of a spigot or a sleeve and which have a uniform or variable cross-section (or cross-sectional geometry) along their length and which are partially or wholly constituted by a liquefiable material, are applied to the surface of the fabric or are introduced into such fabrics and then excited. Advantageously these implants are configured in such a way that the liquefaction begins at predefined points (nozzle, specific areas of the rod). Also in this case it is possible to achieve controlled liquefaction by means of energy directing guides (protruding elements having a defined shape). By implanting the implant below the surface, an anchorage with a deep effect can be obtained. The hydrostatic conditions may be chosen in such a way that the liquefied material is pressed under high pressure into the contiguous tissue areas. The device used for implantation of the implants according to the invention, i.e., for the liquefaction of the liquidizable material of an implant which is in contact with the tissue area and for its injection into the tissue can additionally serve a active control of the distribution of temperatures in the surrounding tissue and in the material, so that it is possible to prevent amounts of heat and unacceptable temperatures, as well as to effectively prevent that vital tissues are thereby affected. The implantation process is possibly guided by an active control of the energy introduced and dissipated (distribution and heat management) by means of a control of the device and optionally by sensors and resistive thermal elements arranged in an appropriate manner. This means that the process is influenced by the determination of the energy introduced and the dissipation of excess energy. The energy applied to obtain the liquefaction of the material is preferably generated by means of a piezoelectric or magneto-resistive excitation. A vibratory unit (for example a piezoelectric element plus a sonotrode), which, commanded by a generator, is excited to vibrate, transmits waves in the frequency range of about 2 to 200 kHz, (for example 20 or 40 kHz), to the implant that has a functional connection with that unit (by pressing the implant against that unit). This implant is coupled to the bone to be attached or to the tissue in such a way that the acoustic energy results in an inner or surface energy absorption by the liquefiable material, which causes it to be liquefied at least locally. The liquefaction process is achieved by a high shear effect. A second component of distinct density, which is locally incorporated in the liquefying material (for example in the form of small spheres), allows to influence the internal friction and by virtue of this the internal liquefaction, as for example the case when cements thixotropic agents containing particles to serve as an implant or part of an implant.

The connections created by the process to be carried out with the aid of the implants and the device according to the invention are mainly based on a perfect fitting effect, the elements on either side of which form the perfect fit may be very small (surface irregularities or surface roughness, tissue pores) or larger (larger 9-well cavities in the tissue or between tissue areas or openings or cavities mechanically opened in the tissue). The ligation implants are mechanically excited by sonication such that they are liquefied in particular in the area of contact with or within the tissue area. The liquefaction is generally carried out on the surface of the tissue area or in a corresponding recess (cavity), which was for example caused by the penetration of the implant from the interface through the surface into the tissue or which has previously been effected by other mechanical means. The effect of introducing the liquefiable material in depth can in a very simplified and schematic manner be described as follows: like a plunger of a hydraulic cylinder the still unfilled liquefied material of the connecting implant is situated in a cavity and fills so as to essentially seal the cavity. Since the liquefied material can not therefore escape from the cavity, a hydrostatic pressure is formed due to the load exerted from the outside (pressure exerted on the implant). This pressure and the ultrasonic vibrations cause the liquefied material to be pressed into hollow spaces already existing and / or just formed in the surrounding material to bind (vital tissue). The depth of penetration of the material depends inter alia on the nature of the surroundings, the adjusted operating parameters and the nature of the liquefiable material (in particular its viscosity). The liquifyable or liquefied volume of the bond implant enables the amount of material pressed into the fabric to be defined. If it becomes necessary to have a lot of material or if the number and number of cavities in the tissue are unknown, it is possible to use implants or 10 implant components that can be subsequently filled with material, at any time.

Voltage peaks created by the displaced and compressed material which could for example lead to bursting of the fabric are avoided, and this is due to a controlled application of ultrasonic and hydrostatic mechanical or hydrostatic pressure to each other, as well as by suitable configuration of implants and the liquidifiable materials applied thereto. Hollow spaces and fissures are filled by the liquefied material, and this, when it comes to sufficiently porous tissue, without making previous drills. By controlled compression and by areas of the material in the adjacent areas of tissue, the ligation implants provide strong retention even in very porous tissues (for example bone tissues attacked by osteoporosis). By virtue of this, high mechanical extraction forces or load capacities can be obtained which, when a material which is at least partly resorbable, is reduced in a controlled manner after the initial stage of a healing process or else these forces are taken up by the tissues which are growing (secondary stabilization). The invention is for example provided for securing a dental prosthesis in a jaw. For this purpose, the dental prosthesis preferably has a standardized base structure having the configuration of an implant according to the invention and which can be attached to various tooth types. The base structure is therefore composed wholly or partly of material which can be liquefied by the application of mechanical energy, which material, after being placed in a cavity already existing in the jaw, is liquefied by the application of mechanical energy, being pressed into the pores of bone tissue. During this operation the implant adapts to the cavity and pores of the tissue, entering into them. As a result of this, a well anchored and immediately stable base (primary stabilization) is obtained for the fixation of the upper part of the tooth, not only inside the tooth cavity in the maxilla but also in the neighboring bone tissues, which later replaced at least in part by regenerated bone tissue (secondary stabilization).

A further field of application of the invention disclosed herein relates to the medical area of the implants and more specifically for example to artificial articulation elements. Both a joint acetabulum as well as a joint head or its stem may be connected by means of the implants according to the invention with the vital bone tissue or be anchored in that tissue. Additionally and to obtain a gentle introduction of the load during implantation the materials used are chosen so as to avoid, as far as possible, stiff jumps, giving all these characteristics a positive contribution to the useful life of the implant. The device used for implantation of the implants according to the invention can in a simplified way be described as follows: a generator is used to generate electrical pulses, which are transferred by a transmission element, for example a cable, to a unit pulsating. The pulsating unit typically has a pulsating element (drive unit) and a resonator, these components having a functional connection to one another. The drive unit (for example a piezoelectric element) excites the production of pulsations by the resonator. Such a device became known from the document of GB-A-2277448, the generic concept of which is based on claim 17. The pulsations of the resonator are transferred to the implant directly or by means of a transmission element. It then passes at least locally to the liquid state because of internal liquefaction processes or as a consequence of contact with a non-pulsating envelope (a tissue or another part of the implant). During this operation the implant can be held in position by a suitable fixation, being guided by means of a guide. Particularly when it comes to minimally invasive surgery, it is convenient to attach the implant directly to the pulsatile unit. Especially advantageous are fixation and / or guiding devices which serve not only for temporary retention or fixation of the implant but also for obtaining temperature (in particular heat dissipation) management.

Because of the way in which the implant material is liquefied in a controlled and localized manner, no significant amounts of heat are produced. In addition the temperature of the tissues neighboring the implant can be actively controlled by means of temperature management, for example by resistive thermal elements, which have a controlled effect of heat dissipation, or by cooling liquids (for example a sterile solution Ringer), which has the effect of controlling the temperature. The method of implanting an implant according to the invention, for example in a human or animal skeleton, is carried out in the following manner: the implant is brought into contact with the part in question of the skeleton, and then mechanical pulses are generated which are transferred to the implant material which can be liquefied by mechanical energy, and this while the implant is pressed against the part in question of the skeleton. Mechanical energy is added for the time required for the liquefiable material to have reached a sufficiently liquid state and to penetrate near the contact zone in the bone tissue or at least in the irregularities on the surface of the part in question of the skeleton. The mechanical pulses are then interrupted, which causes the liquefied material to solidify (advantageously, the hydrostatic pressure is maintained) and the implant is anchored with perfect fit in the part in question of the skeleton.

Binding implants according to the invention have for example the form of spikes, bushes or plates / sheets. They serve to establish a connection between tissues or between tissues and artificial elements.

Advantageously, a kit or assembly comprising at least one type of implant according to the invention is advantageously used for an implant of the kind described above, advantageously however an assortment of implants of different dimensions, suitable for a given field and a device intended to carry out the deployment. Advantageously the kit also includes means for providing aseptic use of the device (sterilized housings for the device) and optionally component replacement parts (in particular the resonator, distal parts of the resonator and the transmission part) that can be sterilized. These resonator parts may also be adapted, if they have different shapes, to different types of implant and / or application. In addition, the kit advantageously comes with implantation instructions, indications on implantation parameters for specific implant types and other tissue preparation aids (eg drills suitable for particular implants), implant instruments positioning, control instruments or implant guides adapted to specific implants and / or resonators.

Preferably the kit or assembly is always maintained ready for use by subsequent deliveries of implants. Assortment is governed by needs and may vary over time. Subsequent supplies (replacement kit or complementary kit) cover, on the one hand, the replacement of used implants, as well as new types of implants, which come again accompanied for example by the respective fabric preparation means, positioning instruments, control instruments, adapted resonators or resonator parts, implant guides and in particular the corresponding instructions for the implementation. The invention is explained in more detail by the following figures. It is shown in:

1 shows by way of example an embodiment of the device for implantation of implants according to the invention, as well as the use of such device;

Figure 2 shows a positioning plate fixed to a bone by means of the implants according to the invention;

Figures 3 and 4 examples of implants according to the invention, which may for example be used in the application 15 according to figure 2, as well as connections thus made between bones and plate;

Figures 5a to 5e are examples of transverse cross-sections of implants according to the invention in the form of a spigot having energy directing guides;

Figures 6 to 8 longitudinal cross-sections of two examples of implants according to the invention in the form of a spigot with implant parts made of a non-liquefiable material;

Figures 9 to 13 show examples of embodiments of fastening means that interact with one another and which are arranged in spigot or chuck implants and in resonators;

14 shows applications of implants according to the invention in the area of human bones of the skull and jaw;

Figures 15 to 17 are examples of implants according to the invention suitable for application to the skull area, and examples of links between two parts of skull bone made with these implants;

Figure 18 is an example of a resonator system for the applications of Figures 16 and 17;

Figure 19 is a further application of the implants according to the invention in the area of the human spine; 16

Figure 20 is a further application of the implants according to the invention for fixing a dental prosthesis; Figures 21 and 22 show two examples of implants according to the invention for the application shown in figure 20; Figure 23 shows a positioning device which is attached to a forearm bone by means of the implants according to the invention; Figure 24 is an example of an attachment implant suitable for the application according to Figure 23; Figure 25 shows a section of the positioning device according to figure 23, fixed to the bone by means of implants according to figure 24; Figure 26 is a further example of an attachment implant suitable for the application according to Figure 23; Figure 27 is a trochanter plate secured with the aid of an implant according to the invention, for the attachment of a fractured femoral neck; Figure 28 is a rod for an artificial joint head fixed to a long bone by means of the implant according to the invention; 17

Figure 29 shows a joint ligament attached to a bone by means of implants according to the invention;

Figure 30 a section of a cavity in a tissue, for example created by a tumor, to be filled or filled with an implant. Figure 1 schematically shows in a very simplified way an example of an embodiment of a implantation device 1 that can be used to implant implants according to the invention. The device 1 comprises a generator 2 and a pulsating unit 3 which are connected to each other by a cable 4. The pulsating unit 3 partly housed in a body 5 has the configuration of a hand-operated apparatus which, as regards its handling , is used in a manner similar to that of a manual drill. The pulsating unit 3 has a pulsating element (not shown in more detail) integrated in the body 5, which element has a functional connection with a resonator 6 (sonotrode). At least a distal part of the resonator projects out of the body 5. The generator 2 supplies the pulsating element with energy. Excited by the heartbeat element the resonator vibrates at a preset frequency or, if necessary, with a preset frequency pattern. Especially suitable are frequencies of 2 to 200 kHz and resonance amplitudes of 1 to 100 μπι in the direction indicated by the double arrow (z-direction). The frequencies can be adjusted according to the field of application, the materials to be liquefied and the shape of the resonator, as well as the implant. It is also conceivable to overlap the pulsations in the ultrasound range in addition to mechanical vibrations, which will, for example, have a low frequency and a large amplitude. In many cases, however, it is sufficient that the device is designed for a single pulse frequency, for example at 20 or 40 kHz, and for example for a resonance amplitude of about 20 to 30 μιη in the z direction (direction in which a implant 7 is pressed by the resonator 6 against a tissue area). To adjust the power (pulsed energy per unit of time) the excitation can be pulsed, for which the distance between pulses and possibly the duration of the pulses can be adjusted.

Advantageously and in a well known manner the pulse rate and the shape of the resonator are so harmonized with each other that the resonator oscillates with a standing wave and its distal end, with which it is pressed on the resonator implant, has a maximum amplitude in the z-direction. In addition, it will be advantageous to impart to the spike implants a length which is tuned to a pre-set excitation frequency and to a predefined implant material. The distal end of the resonator 6 may, as shown in Figure 1, be configured to secure an implant 7, which facilitates the positioning of the implant in a tissue area or in an orifice of a tissue area, in the present case of a leg bone 10. For positioning and implantation without an orifice, an implant guide is provided which rests on the body 5. It is however very possible, in an embodiment not forming part of the present invention, to configure the resonator 6 in the manner of a hammer with a flat front surface and simply pressing such surface against an implant fixed in a hole in the fabric or by a separate guide or fixture which is suitable for this purpose. In a resonator of this type, the necessary measures must be taken so that its distal front surface is not glued to the implant during the implantation operation. This is achieved for example by applying to the front surface of the resonator a suitable, non-adherent material, or by the use of an implant part adjacent to the resonator, which is comprised of a non-liquefiable material.

In order for the device to be used in a sterile operating room, such a device is for example inserted into a sterile housing. Advantageously, the sterilized casing has an aperture to the distal part of the resonator, the resonator or the distal part of which resonator can be removed, replaced or sterilized.

Further embodiments of the implantation device 1 according to the invention have, for example, the configuration of hand-operated devices which comprise all the components (including the electrical supply, for example in the form of an accumulator) or also the configuration of apparatus stationary. Figure 2 shows a positioning or stabilization plate 21 fixed to a part of a bone 20 in the region of a fracture or a fissure of that bone by means of implants 7 according to the invention, plate with the aid of which stabilizes the crack or the fracture. In this case the bone part 20 has an outer cortical layer 22 which is not very thick but rather compact and beneath this layer is a spongiosa type fabric 23 which is porous. Differing from that shown in Figure 2, the transition from the cortex to the spongiosa part is in the natural tissue a gradual transition in which the tissue becomes more and more porous. The implants 7 traverse the plate 21, which for this purpose has holes, as well as the cortex 22 and the spongiosa part 23, and are anchored at least in the spongiosa portion 23. As shown in FIG.

Figures 3 and 4 show in cross-section and on an enlarged scale two examples of implants 7 according to the invention which can be used for example for the application shown in figure 2. Figure 3 shows an implant after implantation and figure 4 another implant which, in order to be able to exert a pulsating energy, is positioned in a bore 24 open in the plate 21 and in the cortex 22.

In order to perform the implantation, at least the cortical layer 22 must be introduced, for example by opening a hole. This bore may, if necessary, extend into the spongious-like fabric 23 in the form of a blind bore. Since the cortex does not have pores suitable for injecting liquefied material into the pressure, it is possible to create in that layer, for example by the opening of a thread 25 or by making the inner walls of the holes, holes or surface roughness in which the pressure is injected the liquefied material, which solidifies forming a perfectly fitting connection. In the spongious tissue 23 the liquefied material of the implant is pressed into the pores, the implant 7 being thus anchored in depth. It has been found that hydrostatic injection to the pressure of the liquefied material in the pores of the tissue saves much more the tissues than the mechanical insertion of a solid material. For this reason it is also possible to establish stable bonds with tissues which do not have a high mechanical resistance, for example bone tissues attacked by osteoporosis. 21

In order to connect the implant 7 with the plate 21 a head can be provided, such as in the mechanical screws and in the manner shown in figure 2. On the other hand and according to figure 3 can also be provided in the plate 21, which is for example made of metal, a thread of the kind also openable in the cork 22, the thread into which the liquefied material penetrates, then solidifying to form a perfectly fitting connection. In this case a head can be dispensed with. The implant 7 is aligned to the face of the plate 21, which is achieved by crimping an implant suitably dimensioned to the desired position and not by cutting the protruding part, which is undesirable.

For a plate 21 made of a thermoplastic synthetic material, as shown in Figure 4, the connection between the plate and the implant (loosening protection) can be effected by means of a body connection (welding or bonding together with the anchor in the fabric). This corporeal bond begins to form when the implant is crimped at the attachment point 26. Also in this case the implant 7 is advantageously crimped to the point that at the end is aligned with the outside of the plate 21.

Since it is not necessary to screw the implants 7 into the fabric, it is also not necessary to configure them, as in mechanically screwed screws, with means which are designed to withstand the introduction of a fairly high torsional force. The dimensioning of the implants may be performed solely for the purpose of their function in the implanted state, i.e., the implants may be thinner and the holes to be opened in the tissue may be smaller than would be the case for conventional screws made of 22 same material. Since the connections with perfect fit are obtained by liquefaction and subsequent solidification of the material, these bonds are subject to less stresses and to smaller shear effects, which increases their resistance even more and makes them less propitious to effects of material fatigue.

Implants according to the invention which, as indicated in figures 2 to 4, must be anchored in depth in a tissue area, advantageously have the shape of a spike or a bush and are provided with the liquefiable material, for example. for example at the distal end, as well as at other regions of the surface thereof to which an anchorage is desired (for example in the thread, in the plate 21 or in the cortex 22). To this end, such implants may, as shown in Figures 2 to 4, be wholly composed of the liquidifiable material, the distal end and the areas of the surface where the material is to be particularly liquefied advantageously equipped with energy directing guides , or such energy directing guides are provided on the surfaces that come into contact with such zones. These energy directing guides are for example distal ends of implants having the shape of a tip or otherwise thinning to form one or more beak areas having a substantially pointed or filiform shape. Other areas of the surface to be liquefied are for example protuberances, nozzles or ribs, whose heights and widths must be adapted to the anchorage to be obtained. The directing guides of the energy project at least 10 μm in relation to the surface, however, they may also be considerably larger and lead in the form of ribs extending in the axial direction, for example to transverse sections of posts provided with protrusions or edges, as is for example shown in Figures 5a to 5e. Spike-shaped implants have cross-sections of this kind along their entire length or only along a part of their length.

In spike implants which, in addition to an anchorage in the region of its distal end are anchored solely along its lateral surface, holes (for example drills) in the tissue must be provided which, upon insertion of the implant, allow at least some points an adjustment by adhesion between the tissue and the implant or energy directing guides, which are therefore somewhat narrower than the cross-section of the implants.

For other functions the liquidtable material may contain foreign phases or other substances. The liquefiable material may be mechanically reinforced, in particular by the addition of fibers or whiskers (for example ceramic or vitreous whiskers based on calcium phosphate), the liquidisable material may furthermore have components which increase in volume or are soluble in the which form pores (for example polyester, polysaccharides, hydrogels, sodium phosphate) or may be added substances which are released in situ, such as growth factors, antibiotics, anti-inflammatories or buffer substances (e.g. sodium), which are opposed to the inconvenient effects of decomposition in an acid medium. Additives can also be imaged to make the material visible on radiographs or similar functions. 24

It has been found that for a spongiosa type anchorage of implants according to Figures 2 to 4, which are composed of polymers, for example PC or PLLA, and have a diameter of 3 to 4 mm, are of an advantageous manner used for the force setting operation in the range of 0.5 to 5 N per mm 2 of implant cross section. Forces of the above order of magnitude allow the implants to be inserted into the tissue at a rate that is greater than 5 mm / s.

Figures 6 to 8 show yet another three examples of spigot-shaped implants 7. These implants have, in addition to the zones made of liquidisable material, a core 11 (Figures 6 and 7) or a bush 13 (Figure 8) of a non-liquefiable material, such as a metal, a ceramic, a glass or a composite material.

The implants according to Figures 6 and 7 have at their distal end a cover 12 made of a liquidifiable material, which cap ends more or less in nozzle (Figure 6) or which has several end zones (Figure 7) which converge in spout or in line form. The side surface of the core 11 is completely encased in liquidifying material (FIG. 6) or only in some parts, these portions extending in the axial direction, may be annularly shaped (FIG. 7), or are evenly distributed or not uniformly over the lateral surface of the implant. Also in these areas of the lateral surface, energy directing guides of the kind already described above with respect to implants made entirely from a liquefiable material should advantageously be provided. Depending on the desired anchoring depth in the side wall area the liquidisable material is thicker or thinner, but should not be thinner than about 10 μιη.

In order to serve as energy directing guides there are also stepped reductions of the cross-section, as shown in figure 6. Implants with such a step are advantageously implanted in correspondingly staggered or narrowing apertures of the fabric. The action on a spike or bush implant with a non-liquidifiable core 11 may extend to the entire proximal end of the implant or else only to the annular outer zone, which is comprised of liquidisable material.

In the implant according to figure 8 the liquidisable material is housed inside the non-liquefiable bush 13. The bushing 13 is provided with holes which are positioned at the points where an anchorage is to be obtained. Such an embodiment of the implant according to the invention is particularly suitable for the application of highly viscous and thixotropic materials which serve as a liquidisable material since such a material is not in a position to withstand the mechanical request of the resonator, which presses on the implant. The holes in the bushing should be dimensioned in such a way that the highly viscous material can not exit normally but may well come out in its liquefied form. In particular, the bearings 13 are made of sintered materials, which are porous. An implant with bush 13 should be positioned in a hole in the tissue, the resonator being resting solely on the liquidifiable material, whereby the cross-section of that resonator should be adapted to the cross-section of the inside of the bush.

At the proximal end of spike or socket-shaped implants, for example, a head-shaped dilation may be provided, an artificial part or other therapeutic auxiliary device may also be attached which replaces or otherwise secures a part of the tissue or may be still a fastening means is provided for a suture wire or for a metal bonding wire. At the proximal end of a spigot or bush implant a fastening means may also be provided which may cooperate with a corresponding fastening means integral with the resonator (see Figures 9 to 11).

A core 11, which will for example be metallic and which is provided in a spur-shaped implant or a sleeve intended to be implanted by ultrasound, usually serves as a mechanical reinforcement for the implant and is dimensioned accordingly. The core can however be considerably thinner and can be easily removed from the implant. In this case, such a core serves, for example, to make the implant visible on the radiograph, for example when it is a minimally invasive implant, or to serve as guidewire, and is withdrawn again directly after implantation.

An implant with a core which will be for example metallic and which according to the invention is anchored in the tissue by means of a liquidifiable and resorbable material gives this material an immediate primary stability. Due to the degradation of the anchoring material this anchorage is released, a stabilization created by the implant being dynamized, so that successively more effort is to be borne by the tissue, which promotes a natural process of regeneration and in many cases avoids processes of degradation. After degradation of the liquidifiable material the core can be removed very easily whenever its surface is configured in such a way that vital tissue does not bind to that surface. In cases where its surface is however configured in such a way that adhesion (biologically active surface) is promoted, ideal secondary stability is obtained for an implant remaining in the tissue or for an implant core which must remain in the tissue (see also figure 28). Implant cores of the kind shown in Figures 6 and 7 may be made of not only metal (for example of different types of steel, titanium or cobalt and chromium alloys) but also, depending on the application, be made of synthetic materials (for example polyetaryl ketones, polyfluoroethylene and / or polychloroethylenes, polyethyrimides, polyether sulfones, polyvinyl chloride, polyurethanes, polysulfones and polyester) or ceramic or glass materials (for example aluminum oxide, zirconium oxide, silicates, ceramics or calcium phosphate glasses) or composite materials (eg high-temperature thermoplastics reinforced by carbon fibers).

Figures 9 to 13 show examples of various applications for attaching an implant in the form of a spigot or a bush 7 according to the invention into or adjacent to the distal part of a resonator 6 (sonotrode) of the implantation device 1 (figure 1) . This fastening can for example be a snap fit, as shown in Figures 9 and 10. The perfect fit is for example realized in the form of a snap-fit closure (Figure 9) of a proximal extension 14 shaped of an implant core 11 or an implant 7 which can be inserted into a corresponding aperture 15 in the distal end of the resonator 6 engaging the aperture. The snap-fit connection can also be realized with the aid of a correspondingly locked spike 16 which extends through the resonator 6 and the proximal extension 14 of an implant core 11 or the implant 7. For this advantageous use the measures necessary so that the perfect fit is located at a distance d from the distal end of the resonator, at which point for the pulsations in the z direction is located a node, where at that point the amplitude in the z direction is therefore essentially zero . Figure 11 shows an adhesion bond between the resonator 6 and the implant 7, and this by means of the threaded connection 17. If this threaded connection is subjected to a previous tension such that the pulsations propagate without attenuation beyond the boundary surface, the implant 7 becomes a part of the resonator 6 and must be correspondingly dimensioned. This means that the distal end of the resonator 6 need not have any maximum amplitude of the z-direction, whereby a node may also be located at the connection point.

Figures 12 and 13 show advantageous implant anchorages 7 in the resonator 6 for implants whose proximal end is comprised of the liquidisable material. These are both ultrasonic shaping and splicing of the proximal end of the implant 7 at the distal end of the resonator 6, which effect is initiated by means of suitable energy directing guides of the resonator 6 Figure 12 shows a resonator 6 having a distal surface having the shape of a hammer percussion surface to granulate, while the other part of Figure 12 shows a resonator 6 with a central directing guide of energy. In both cases the proximal end of the implant 7 is brought into contact with the energy directing guides of the resonator 6, which resonator 6 is pulsed. The liquefiable material situated in the region of the resonator energy directing guides is one which is first liquefied and adhered to the resonator, assuming the shape of that distal surface and forming a head 18 in the case shown in Figure 12. The fastening of the implants of the kind shown in Figures 9 to 13 is advantageously carried out prior to positioning the implant on the surface or within the tissue area, which fixation is again released after implantation, in which case according to Figures 12 and 13 by means of a force by which the resonator 6 is released from the implant 7, for example by breaking the connection or by twisting the connection. Figure 14 shows by way of example of further fields of application of the implants according to the invention the fixing of a cover plate 30 made of bone or an artificial material that is fitted to an opening of the cranial vault 29 and the fixation of an attachment plate 31, which will for example be artificial, on a fractured or cracked maxilla 32. Similar applications are feasible in the field of restorative surgery of the face area. The connections to be established between the cover plate 30 and the surrounding bone tissues are advantageously limited to selected points of the slot 33 between the plate and the native bone. Likewise, the attachment plate 31 is attached to the maxilla bone at selected sites 31 'of the plaque. The connections at the selected points are obtained by consecutive deployment steps, using the deployment device 1.

Figures 15 to 17 show in cross-section and on an enlarged scale connections which can be obtained with implants 7 according to the invention and which lend themselves for example to the applications shown in figure 14. Figure 15 shows an implant 7 according to the invention which is positioned (on the top side) to obtain a connection at least located between the skull bone 29 and a cover plate 30 to be inserted into an opening of the skull bone, which plate is for example made of a porous material (for example a bone of the cranial vault) and then implanted by means of sonic energy (double arrow) to connect (from the underside), passing over the slot 33, the bone 29 of the vault with the cover plate 30. The slit 33 advantageously has a sloped configuration such that compressive forces exerted from the outside on the region of the slit are supported by the cranial vault 29, the slit 33 being enlarged from the outside to allow the positioning of the implant 7 The implant having, for example, the shape of a sphere or a chorizo and which is made of a thermoplastic or thixotropic material, is positioned in the external enlargement of the slit and subjected to the action of pulsating energy. Accordingly, the implant material is liquefied by entering the pressure from one side into the pores of the cranial vault 29 and the other side into the corresponding pores of the bone covering plate 30 or entering into artificially open openings (for example groove drawn by dash and dot) correspondingly distributed on an artificial plate. In this way a perfectly coupled anchoring connection is created between the cranial vault 29 and the cover plate 30. Figure 16 shows a fastening sheet 35 which may also be in the form of a flat textile structure and which may for example be used for the local fixation of the cover plate 30 in the opening of the cranial bone 29. The sheet 35 has, for example, shape of a strip and is advantageously flexible. It is entirely made up of a liquefiable thermoplastic or is for example reinforced by a fiber mat or by a similar structure. This structure is placed above the slit 33 and excited on both sides (double arrow) with the aid of the implantation device (figure 1) in such a way that it is glued onto the surface of the cranial vault 29 and the cover plate 30 (connection large and shallow, which may also be limited to a multiplicity or pattern of singular points of attachment). If necessary, parts of the surface on which the implant is intended to be attached to the material underneath the implant are subjected to a corresponding pretreatment (for example made rough) or else 30 surface reliefs are provided on the artificial plate (irregularities of the surface, recesses, grooves, etc.). To attach the sheet 35 to a bone surface suffices a pressure in the order of magnitude of 0.5 to 3 N per mm 2 of the front surface of the resonator. Figure 17 shows a fastening plate 36 which is fixed above the slit 33 with the aid of a fastening sheet 35 or a corresponding flat textile structure, which plate to be able to support correspondingly larger forces is for example made of metal and can therefore be used, in conjunction with its application to the skull, also in an application to the maxilla, which is also shown in figure 13, or else in the application according to figure 2. The fixing plate 36 is thus formed by a material which in the sense of the present invention is non-liquefiable and which has on its surface facing the textile structure a surface relief suitable for creating a perfect fit. The film 35 is positioned between the plate 36 and the textile structure or the material to be secured and subjected through the plate 36 at least locally to the pulsating energy, thereby being in connection with the surface of the cranial vault 29 or the cover plate 30. The perfectly fitted connection between the sheet 35 and the fastening plate 36 may be effected during implantation or the plate 36 may be used in conjunction with the sheet 35 attached thereto to form an implant ready to be applied. In a two-layer implant of the kind referred to the bond between the layers may also be a body bond (bonding or welding). In a two-layer implant of this kind the sheet 35 may also be limited to a coating of the plate, which coating advantageously does not have a constant thickness but which, in the manner of energy directing guides, is constituted by a pattern of protrusions, nozzles or ribs, which have a minimum height (coating thickness) of about 10 μιη. The securing plate 31 shown in Figure 14, for example, has sheet regions 31 'disposed in corresponding cutouts and has an outer surface provided with energy directing guides, being connected at these points to the maxillary bone situated below the plate.

Especially in the application shown in figure 16 it may be advantageous to configure the resonator used in such a way that the pulses transmitted to the implant are not oriented perpendicular to the connection surface to be obtained (z-direction), as outlined in the figures by means of double arrows, but parallel to this direction (direction x / y). For this purpose, a transmission element 37 of the type shown in figure 18 is provided in certain circumstances. This transmission element 37 is perfectly connected to the resonator 6, and this is at a point where the pulsating wave has a node (amplitude = 0) in the z-direction, which is why the wave has a maximum amplitude in the x / y direction. This pulsation in the x / y direction is transmitted by the transmission element 37 to the film 35. Figure 19 schematically shows in a very simplified way, by way of example of yet another application of the implants according to the invention, a support element 40 to the region of the human spine. The support member 40 is elastic and supports the spinal region in a stationary manner and optionally also temporarily. The bearing element 40 is attached in the context of the present invention to bodies of vertebrae, and that in that the same element is made of a correspondingly liquefiable material, being attached to the bodies of the vertebrae or superficially (similarly to the connection of figure 16 ), in that it is made of a non-liquefiable material and is bonded by means of a sheet and not in depth (analogously to the arrangement of figure 17), or with prior drilling and in-depth effect (similarly to the arrangement 34 of the figures 2 to 4). In the figure there are represented spike-shaped implants 7, which have, for example, a head protruding from the support element, which head is made in the manner shown in figure 12. For a stationary support, supporting elements made of non-resorbable materials, while for temporary support one can think of parts made of resorbable materials.

Figure 20 shows the application of a bushing-shaped implant 7 according to the invention, serving as the basis for an artificial tooth 40 to be implanted in a jaw bone 32. The implant 7 is at least partially constituted by a thermoplastic or thixotropic material. From the front side, this implant has means for fixing an artificial tooth 40, a bridge or a prosthesis. The implant is introduced with or without the artificial tooth into a corresponding cavity 41 and pressed into that cavity under the effect of an ultrasound vibration. Since during this operation at least a part of the implant liquefies, the material fills not only the cavity to a large extent but also enters the pressure in the pores of the maxillary bone, so that a connection with deep effect is obtained, as is found for example shown in cross-section in figure 21. Figure 22 shows in cross-section an example of yet another embodiment of the implant according to the invention, which is particularly suitable for use of the kind shown in figure 20. Here, an implant whose part of liquidisable material is not disposed on the surface but within a bushing 13 which is permeable to the liquefiable material when it is in the liquefied state, as already described with respect to Figure 8. The implant is shown in longitudinal section to the left of the center line prior to the application of the ultrasound and to the right of the center line after the ultrasound application. The bushing 13 is made, for example, of a sintered ceramic or metal material with open pores, which serves as a support for the implant. In the case shown, the bushing has an opening 42, which is for example provided with an internal thread, on which an artificial tooth, bridge or dental prosthesis can be fixed. This bushing has a further annular aperture 43 in which the liquefiable material is positioned, for example a cylindrically shaped portion 44 of the liquefiable material. In order to obtain a controlled liquefaction, energy directing guides 45 are disposed within the annular aperture 43 with which the liquefiable material is in contact. The implant according to figure 22 is positioned, for example, in a cavity of a maxillary bone (reference index 41, figure 20), the liquidisable material being then subjected to the action of the mechanical energy with the aid of an annular shaped resonator 6 in its distal part. Accordingly, the material is liquefied and pressed so as to pass through the porous material of the bushing into the surrounding bone tissue, which causes the implant to be anchored in that tissue.

For the application shown in Figures 19 and 20 it will be particularly advantageous to choose a material which can be reabsorbed for the liquefiable material, while the carrier part is made of a material which is neither liquefiable nor resorbable and which provides a sufficiently large mechanical strength for fixing the tooth, bridge or prosthesis. To this end at least the surface of the central part is biologically active (e.g. porous, as described with respect to the bush 13), i.e., that surface encourages welding with the bone tissue. An implant of this type immediately presents a primary stability immediately after implantation, which is sufficient for the fixation and normal use of the teeth, bridges or prostheses. The resorbable material is then gradually replaced by vital material and is then attached to the central part of the implant, which is encouraged by the biologically active surface of that part. The implant according to the invention therefore offers immediate primary stability, without the need for cement, and after the resorption or regeneration phase a lasting secondary stability, which lags behind the stability of known implants. In comparison with already known implantation processes a transient phase is however suppressed in which according to the current state of the art the cavity 41 is closed and the regeneration of the bone tissue is awaited before the tooth, the bridge or the prosthesis are fixed directly into the regenerated bone. Figure 23 shows an external fixation device 51 with supports 52 and with a support bar 53 connected to the supports 52, which device is fixed for example in a long bone 50 of a human arm by means of the implants according to the invention . For this purpose the supports 52 are designed to constitute implants according to the invention. The middle part of a long bone mainly exhibits cortical tissues and only a few areas of tissue which, in the sense of the present invention, should be considered porous. Therefore, as shown in more detail in Figures 24 and 25, the space 54 of the bone marrow within the long bone 50 is used to press the liquidisable material into that space. Since the medulla can only withstand the insufficient resistance to the hydrostatic pressure, the bearings are for example provided with base plates 55.

In order to fix the fastening device, 50 holes 56 (if necessary provided with thread 25) which extend into the space 54 of the spine, the diameter of the hole corresponding to the diameter of the implant 7, namely to the diameter of the implant the base plate 55 of this implant. The implant 7 has a bearing 52 in a central position at the distal end of which the base plate 55 is fixed and around which, as well as the bottom plate 55, a ring or tube-shaped zone 57 is arranged which essentially covers those parts and which is made up of liquefiable material. The implant is inserted into the bore 56 and secured at a pre-set depth with suitable means which are applied from the outside. The ultrasonic blending material 57 is then pressed all the way back against the base plate 55 in such a way that the material is pressed between the bone 50 and the base plate 55 inwardly of the bone space 54, thereby forming a perfectly fitting connection which maintains the support 52 in position within the hole 56. This anchoring allows a unicortical and misalignment-proof attachment of the abutments 52, which according to the current state of the art is only possible by means of a bicortical fixation. Figure 26 shows yet another embodiment of the implant 7 according to the invention, which particularly lends itself to the application shown in Figure 23. In this case the liquefiable material, which is for example a thixotropic cement, is disposed in the interior of the bearing 52, holes 58 are provided above the base plate 55 whose size is such that the cement can not exit through these holes in its highly viscous form but may well come out in its liquefied form, this by the action of the resonator 6. The end of the bearing 52 is in this case thus configured in the manner of a bushing of an embodiment equivalent to that of Figure 8. The cement squeezed with the aid of the resonator 6 through the holes 58 immobilizes the bearing within the hollow space 54 of the medulla and eventual contiguous bone tissue. Figure 27 shows a tensioning screw 60 equipped to form an implant according to the invention, which bolt is used for example in conjunction with a trochanter plate 61 for fixing the fractured bone of the femoral neck. The tensioning screw 60 is hollow (equivalent to the implant bushing 13 of Figure 8) and has at least in its distal zone holes through which a liquidizable material may emerge so as to be able to anchor this distal area, for example in a wholesale bone tissue by osteoporosis, than would be possible solely by the action of the thread of the tensioning screw. In the present case the thread of the screw therefore serves in particular to compress the tissue in the area of the fracture point, and this until the distal end of the screw has been anchored in the fabric by means of the liquidisable material. Figure 28 shows in a very schematic and cross-sectional representation a long bone 50, in which an artificial joint element 62 is secured by means of an implant 7 according to the invention. The shank 63 of the hinge member 62 and the liquidisable material 57 disposed around the shank constitute the implant 7 according to the invention, which is depressed under the effect of the ultrasound into the long bone 50, to which the material 57 is liquefied and penetrates the pores of the spongiosa-like tissues 23 and the irregularities of the surface on the inside side of the cortex 22. Advantageously, the shank 63 exhibits, in a manner equivalent to that of the plate 36 shown in Figure 17, a surface relief suitable to create a perfect fit connection with the liquidifiable material 57.

An especially advantageous embodiment of the shank 63 is in particular made of titanium and has a porous and therefore biologically active surface, which surface is surrounded by a liquefiable material which is resorbable. An implant of this kind immediately presents a certain primary stability after implantation, which allows the implant to be subjected at least to moderate efforts. The primary stability is then replaced by a secondary stability, which is a stability created by the adhesion of vital bone tissue to the porous surface of the titanium rod 63. This means in other words that the artificial joint element can be stressed immediately after implantation, even without cement being used, which favors the regeneration of vital tissue and prevents degradation (osteoporosis). In spite of this, vital tissue enters a subsequent phase in adhesion with the titanium rod. Figure 29 also shows in a very schematic way a joint 70 in the area of which a ligature 71 connects the bones 72 and 73 together. The ligament 71 is connected to the bone, which can rupture in the event of overload. For the repair, implants 7 according to the invention can be used, for example 40 to 40 such effects can be applied, in an appropriate manner, according to figures 2 to 4. To this end the joint bone cortex , spigot-shaped implants 7 being pierced through the ligament 71, which implants are provided on the outside of a retaining head (for example according to Figure 13).

Embodiments with a lower depth action may also be envisaged, in accordance with Figures 16 and 17. Figure 30 finally shows that making a connection with a similar implant but not according to the invention need not necessarily serve to connect two elements (two tissue areas or a tissue area and an artificial component). It is also contemplated to use an implant to fill a tissue cavity 80, for example caused by a tumor. For this purpose an implant 7 made of a highly viscous and thixotropic material 81 is advantageously used which, if necessary, is introduced into the aperture 80 with the aid of a guide 82 positioned around the aperture so as to overlap it. The resonator 6 used for this application corresponds, as regards its cross section, to the cross-section on the inside of the guide 82, so that with this guide it is possible to press in the same way as with a cylinder the material 81 inwards of the aperture 80. During this operation the aperture 80 is not only filled in full but the material 81, which becomes more liquid under the effect of the ultrasound, is also pressed into the tissue pores that open into the aperture 80, forming within said pores, upon solidification of the material, a perfectly fitted connection, as shown in Figure 30. This perfectly fitting connection securely attaches the implant 7 to the aperture 80 without the latter having to present to the implant. and without it being necessary to apply other fastening means (for example periosteum pieces sewn over the aperture).

To the liquefiable material 81 may also be added bone material from the patient, which has been pre-prepared so as to have a suitably fine granulometry.

If, instead of a thixotropic cement used in a case of the kind shown in figure 30, a thermoplastic synthetic material is used, the aperture 80 may also be a specially prepared aperture, it being possible to fix within that aperture and with the aid of the synthetic material a fixing element 83 for a metal wire 84, as shown in the dash and dot in figure 30 (only at the bottom of the illustration).

Example 1

Plates made of PLLA and polycarbonate produced by an injection molding process, having a circular cross-section and having diameters ranging from 3.5 to 4.25 mm, as well as lengths of 26 to 40 mm (ideal length at 20 kHz: 35 mm) and with distal ends in the form of a beak, and with axially extending splines extending 10 mm from the distal end, were anchored at a 20 kHz excitation frequency in a spongiosa-like tissue (femoral neck ) of freshly slaughtered bovine animals. To this end, the thin layer of cortex above the spongiosa-like tissue was opened, but this layer of spongiosa was nevertheless pre-pierced. The implants were pressed against tissue at pressures of 60 to 130 N and excited at the excitation frequency (sonotrode amplitude: about 20 to 25 μιη). The feed rate was limited to 10 mm. This depth was in all cases reached in less than 2 s. The implants were then held in position for 5 s without excitation.

Anchor depths of the order of magnitude of 15 mm were obtained which, when the implant was started, presented a greater resistance than the implants themselves (the implants were pulled out with maximum forces greater than 500 N). In the sensors that were positioned in the cortex with a spacing of 1 mm in relation to the previous drilling (1.5 mm below the surface of the cortex), temperatures of up to 44 ° C were measured approximately 10 s after the start of implantation 22 ° above room temperature). The excess temperature dropped by about 30 s to half the value.

With respect to the PLLA-based material, no degradation of molecular weight was observed in the implanted material as compared to the material of the implant not yet implanted.

Lisbon, 22 November 2006 43

Claims (35)

An implant (7) for achieving a perfect fit connection with a tissue area, thereafter connecting said tissue area with another tissue area or with an artificial element, which replaces or supports another further tissue area or is a therapeutic auxiliary device, the implant (7) being at least partially constituted by a material that can be liquefied by the application of mechanical energy and the liquidisable material being disposed in the implant (7) so as to be brought into contact with the area of the implant being able to be excited by mechanical pulsations and simultaneously being pressed against the tissue area to liquefy at least a portion of the liquefiable material and to press such material into the cavities of the tissue area. Implant according to claim 1, wherein the liquidisable material is thermoplastic or thixotropic. An implant according to any of claims 1 or 2, wherein the liquidisable material comprises at least one resorbable component. An implant according to any one of claims 1 to 3, wherein the liquidisable material contains additive substances intended to provide other functions. Implant according to any one of claims 1 to 4, wherein said implant is in the form of a spike or a bush. 1 The implant according to claim 5, wherein it has a material proximal area which is liquefiable by the application of mechanical energy. An implant according to claim 5 or 6, wherein it has a proximal region in a head-shaped configuration. The implant according to claim 5, wherein the liquefiable material is disposed on a surface of a distal end of the implant and / or on a side surface of the implant and wherein the liquefiable material has steps which function as guides for directing the energy. The implant according to claim 5, wherein the liquidizable material is disposed on a surface of a distal end of the implant and / or on a side surface of the implant and has a core (11) made of a non-liquefiable material. An implant according to claim 5, wherein it has a bush (13) made of a non-liquefiable material, the liquefiable material being disposed within the bush and the bush having holes (58) intended to allow the exit of liquefied material. An implant according to claim 9 or 10, wherein the liquidizable material is resorbable and the core (11) or the bush (13) has at least in part a surface which promotes adhesion with the tissue area in question. 2 An implant according to any one of claims 4 to 11, wherein it has securing means (14, 15) at its proximal end. An implant according to any one of claims 1 to 4, wherein it is in the form of a plate (35 and 36) or a sheet (35). An implant according to claim 13, wherein the plate or sheet (35) is a single layer. An implant according to claim 13, wherein the plate (35 and 36) or the sheet have a layer of the liquidisable material and a layer of a non-liquefiable material and wherein the liquidisable material covers at least a part of the surface of the non-liquefyble material, the two layers being bonded to one another with a perfect fit or by means of a body connection. An implant according to any one of claims 1 to 15, wherein it is an anchoring means for an artificial supporting or securing member, for an artificial hinged member, for an artificial tooth, for a bridge, for a prosthesis, a suture wire, a cerclage metal thread or a therapeutic auxiliary device. An implant implant device (1) according to any one of claims 1 to 16, with a generator (2), a pulsating element and a resonator (6), the generator (2) being equipped to make that the pulsating element is excited to produce mechanical pulses, the resonator (6), which has a functional connection with the pulsating element, forms a pulsating unit (3) and the resonator (6) can be functionally connected to the resonator (7) for transmitting the mechanical pulses, and the latter being configured to press the implant (7) against the tissue area, characterized in that the device further comprises an implant guide supported on a body (5). Deployment device according to claim 17, characterized in that the device is designed for the resonator (6) to produce mechanical pulses with a frequency of 2 to 200 kHz. Deployment device according to any of claims 17 or 18, characterized in that it is possible to set different frequencies for the mechanical pulses, distinct frequency patterns and / or pulsations other than energy. Deployment device according to any one of claims 17 to 19, characterized in that the resonator (6) or a distal part of the resonator (6) is interchangeable or sterilizable. Deployment device according to any one of claims 17 to 20, characterized in that the resonator (6) is arranged to hold an implant (7) in the form of a spigot or a sleeve. A kit for making connections with tissue areas, which kit is equipped with a implantation device (1) comprising a generator (2), a pulsating element and a resonator (6), the generator (2) provided in order to excite the pulsating element so as to cause in the same mechanical pulses, the resonator (6), which has a functional connection with the pulsating element, forms a pulsating unit (3), and the resonator (6) can have a functional connection with the implant (7) for transmitting the mechanical pulses, and in that said resonator is equipped to press the implant (7) against a tissue area, and in that said kit comprises multiple implants (7) according to any one of claims 1 to 13. Kit according to claim 22, characterized in that the kit comprises a plurality of spigot-shaped implants and at least one plate (21) provided with orifices adapted to the spigot-shaped implants (7). Kit according to claim 23, characterized in that the plate (21) is made of metal, in that the spike-shaped implants (7) present in a proximal area which connects with the plate (21) material which can be liquefied by the application of mechanical energy, and that the holes are provided to provide a perfect fit with the liquidisable material. Kit according to claim 24, characterized in that the holes are provided with an internal thread. A kit according to claim 23, characterized in that the plate (21) and / or a proximal end of the implant have liquidisable material in such a way that the plate (21) and the proximal end of the implant can be welded or glued together to the other by the application of mechanical pulses. Kit according to claim 22, characterized in that the resonator (6) of the implantation device (1) has at its distal end retention means and in that the implants (7) are in the form of spikes or bushings and in that the the proximal end thereof has retaining means adapted to the retaining means of the resonator (6). Kit according to claim 27, characterized in that the retaining means of the implant and the retaining means of the resonator are configured to provide a snap-fit attachment. A kit according to any one of claims 22 to 28, characterized in that it comprises a plurality of spigot-shaped or bush-shaped implants, as well as resonators (6) or distal resonator parts, the distal surfaces of which correspond to the proximal cross-sections of implants. A kit according to any one of claims 22 to 29, characterized in that at least a part of the implant (7) is in the form of a spigot and in that the kit further comprises drills whose diameter is adapted to the larger diameter of the implants (7) , in order to obtain an adjustment by adhesion. A kit according to any one of claims 22 to 30, characterized in that at least a part of the implants (7) has the liquidisable material inside a bush (13) provided with orifices (58) and in that the kit is further provided with a resonator (6) or a distal resonator part whose cross-section is adapted to the inner and proximal cross-section of the bush (13). A kit according to any one of claims 22 to 31, characterized in that the kit further comprises guides (82) with an aperture and at least one resonator (6) or a resonator distal part whose cross-section is adapted to that aperture. A kit according to any one of claims 22 to 32, characterized in that it is furthermore provided with sterilized shells for the implantation device (1). A kit according to any one of claims 22 to 33, characterized in that it is possible to set different pulse frequencies, different frequency patterns and / or different pulsations of energy in the implantation device (1) and in that the kit is further provided with instructions for the different implants. A complementary kit with one or more implants (7) according to any one of claims 1 to 16, which complementary kit is further provided with instructions for implanting the implants mechanically with the aid of pulsating energy. Lisbon, 22 November 2006 7