US20160135961A1 - Device to be implanted in human or animal tissue and method for implanting and assembling the device - Google Patents
Device to be implanted in human or animal tissue and method for implanting and assembling the device Download PDFInfo
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- US20160135961A1 US20160135961A1 US15/004,181 US201615004181A US2016135961A1 US 20160135961 A1 US20160135961 A1 US 20160135961A1 US 201615004181 A US201615004181 A US 201615004181A US 2016135961 A1 US2016135961 A1 US 2016135961A1
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- bone
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- intervertebral element
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Definitions
- an implanted implant or endoprosthesis in situ assembly
- further part protrudes from the tissue in which the implant or endoposthesis is implanted
- implants or endoprostheses which are implanted in the tissue by further implants (e.g. cross pins for securing the shaft of an endoprosthesis shaft).
- the known in situ assemblies are usually based on a bore in one of the parts and a corresponding bolt, cone or screw on the other part.
- Suitable non-resorbable liquefiable materials for first joining locations and possibly also for the anchorage of a device part are e.g.: polyolefines (e.g. polyethylene), polyacrylates, polymethacrylates, polycarbonates, polyamides, polyesters, polyurethanes, polysulfones, liquid-crystal-polymers (LCPs), polyacetals, halogenated polymers, in particular halogenated polyolefines, polyphenylene sulphones, polysulfones, Polyaryletherketones (E.g.
- FIG. 6 shows a matched pair of joining locations F and S similar to the joining locations according to FIG. 5 wherein the second joining location structure comprises undercut protrusions (e.g. heads or combs with a narrower neck region) instead of openings. These protrusions, if equipped with more or less sharp edges or points act as energy directors also.
- undercut protrusions e.g. heads or combs with a narrower neck region
- the barbs may also constitute the structure of the second joining location (second joining location according to FIG. 6 ).
- FIGS. 15 and 16 illustrate a second group of exemplary embodiments of aspect A of the invention. These embodiments differ from the above described embodiments of a first group in that the opening in the bone tissue in which the base part 1 of the device is anchored is not an opening which is made in the bone tissue but is the marrow space of a tubular bone 45 .
- the device is e.g. an endoprosthesis replacing a joint part.
- FIG. 31 shows the two vertebral bodies 51 and the intervertebral element 50 therebetween from the front side.
- the base part 1 on the right hand side is positioned for application of mechanical vibration and pressure using a vibrating tool 12 (sonotrode).
- the base part 1 on the left hand side is joined to the intervertebral element 50 and is anchored in the vertebral end plates.
- the further device part is an intervertebral element 50 for being positioned between to vertebral bodies 51 to replace an intervertebral disc or for fusing the two intervertebral discs.
- the based part is in this case the vertebral body 51 adjoining the intervertebral element 50 .
- the intervertebral element is e.g. made of a non-liquefiable material and comprises at least one through opening whose proximal mouth is accessible from a front or lateral side of the vertebral column and whose distal mouth opens towards the bone tissue of the vertebral body 51 .
- the through opening does not have a straight axis but a bent one, wherein the angle between the proximal part of the opening and the distal part is between 110 and 160 degrees or preferably between 135 and 150 degrees.
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Surgery (AREA)
- Neurology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rehabilitation Therapy (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
- Dental Prosthetics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
An implant or endoprosthesis suitable to be implanted in human or animal tissue includes two (or more than two) parts to be joined in situ. Each one of the parts includes a joining location, the two joining locations facing each other when the device parts are positioned for being joined together, wherein one of the joining locations includes a material which is liquefiable by mechanical vibration and the other one of the joining locations includes a material which is not liquefiable by mechanical vibration and a structure (e.g. undercut cavities or protrusions) suitable for forming a positive fit connection with the liquefiable material. The joining process is effected by pressing the two device parts against each other and by applying ultrasonic vibration to one of the device parts when the two parts are positioned relative to each other such that the two joining locations are in contact with each other.
Description
- The invention is in the field of medical technology and concerns a device to be implanted in human or animal tissue, i.e. an implant or endoprosthesis. The device comprises two or more than two device parts which are equipped for in situ assembly, i.e. to be joined during the implantation operation and in the implantation site. The invention further concerns a method for implanting and assembling the device in a human or animal patient, in particular implanting it in bone tissue of the patient.
- According to the state of the art, implants or endoprostheses consist of metallic, ceramic or polymer materials. Some known implants or endoprotheses comprise a plurality of parts which are assembled either when being manufactured or immediately before implantation and before being positioned in the implantation site (ex situ assembly). The parts e.g. consist of different materials and form implant regions having different functions, as e.g. described in the publications WO 2004/017857 or WO 2005/079696. The parts may also come in sets comprising a selection of part shapes or part sizes, wherein parts are chosen and assembled immediately before implantation (ex situ) to fit the individual implantation site (described e.g. in U.S. Pat. No. 5,593,425, Bonutti). Furthermore, it is known to fix a further part to the proximal end of an implanted implant or endoprosthesis (in situ assembly) which further part then protrudes from the tissue in which the implant or endoposthesis is implanted (e.g. crown mounted on a dental implant or ball mounted on the shaft of a hip joint prosthesis). It is further known to secure implants or endoprostheses which are implanted in the tissue by further implants (e.g. cross pins for securing the shaft of an endoprosthesis shaft). The known in situ assemblies are usually based on a bore in one of the parts and a corresponding bolt, cone or screw on the other part. Due to the named assembly means the freedom which these assemblies can offer regarding selectable relative positions for the assembled parts and therefore their applications are very limited. In the above mentioned publication U.S. Pat. No. 5,593,425 it is suggested to assemble endoprosthesis parts, of which one comprises a thermoplastic material, by heating this thermoplastic material and therewith make its surface tacky and to bring the heated and therewith tacky surface in contact with a non-thermoplastic surface of an other endoprosthesis part in order to adhere it there. This method allows more freedom of relative placement of the endoprosthesis parts relative to each other, but the strength of the resulting connection is limited.
- It is the object of the invention to create a device to be implanted in a human or animal patient, the device being an implant or endoprosthesis and comprising at least two parts to be assembled in situ. It is a further object of the invention to create a method for implanting and assembling the device. The device and the method according to the invention are to be more universally applicable than known multi-part implants or prostheses for in situ assembly and are to allow more flexibility regarding the relative position of the assembled parts relative to each other, but still resulting in a strong connection between the implant or prosthesis parts.
- This object is achieve by the device and the method according to the invention.
- The device according to the invention comprises two (or more than two) parts which parts are equipped for being assembled, i.e. joined together, using mechanical oscillation, in particular ultrasonic vibration, which is applied to one of the parts by contacting this part with a mechanically vibrating tool. The device parts usually consist of an artificial material but some of the parts may also consist of bone tissue. Each one of the two parts of the device comprises a joining location, the two joining locations being matched to each other for being in contact with each other when the parts are positioned to be joined and for being connected to each other after the joining process, wherein the resulting joint is a positive fit connection.
- For achieving a positive fit connection, a first one of each matched pair of joining locations comprises a material having thermoplastic properties and being liquefiable by mechanical vibration, which material forms the surface of the joining location or can be pressed to this surface from the inside of the part by application of the mechanical vibration. A second one of each pair of matched joining locations comprises a material which is not liquefiable by the mechanical vibration to be used for joining the two device parts (e.g. metal, ceramic material or polymer with duroplastic properties or with thermoplastic properties but with a melting temperature which is relevantly higher than the melting temperature of the liquefiable material) and it further comprises a structure being suitable for a positive fit connection with the material of the first joining location when this material is liquefied, made to penetrate into the structure and to re-solidify within this structure. The structure of the second joining location comprises an undercut cavity or protrusion or a plurality of undercut cavities or protrusions, wherein one or a relatively small number of cavities (e.g. bores or grooves) or protrusions having a defined form and a size of preferably a few mm is provided and/or a large number of cavities and protrusions having random forms, i.e. being formed by e.g. an open-porous surface material or a surface coating consisting of assembled particles (e.g. sintered material). For enabling penetration of the surface structures by the liquefied material of the first joining location and for realizing a stable joint, the cavities of the porous or particulate surface material need to have a size of at least about 0.3 mm and the surface structure needs to have a depth which is at least twice as large as the fineness of the structure (pore size of the porous material, particle size of the particulate coating).
- At least one of the device parts to be joined together further comprises a contact location in which it is able to be contacted with a vibrating tool (e.g. sonotrode of an ultrasonic device) for the joining process. The part comprising the contact location may comprise the first or the second joining location.
- At least the device part comprising the contact location and preferably both device parts are designed as mechanically stable oscillators such that mechanical vibration applied to the contact location is transmitted by the oscillator to the joining location with as little damping loss as possible and in particular without reduction of the mechanical stability of the oscillator during the application such that it becomes possible to liquefy enough (but not more) material in the region of the joining locations for achieving the desired positive fit connection but without further changing form or material of the device part. For achieving good oscillator properties the device parts are made of materials having an elasticity module of at least about 0.5 GPa for low damping losses. The surface of either joining location is preferably equipped with protruding energy directors (protruding pyramids, cones, combs etc. having a height of at least 10 μm) which, on application of the vibration, locally concentrate the vibrational energy such causing high local shearing stresses and therefore local and fast liquefaction of the surface material even if the melting point of this material is as high as 200 to 450° C. By such local liquefaction, the amount of material which is liquefied can be kept small (e.g. just enough for penetrating the structure of the second joining location) and therefore the thermal loading of the tissue remains within physiologic limits (allowing for functional regeneration of the tissue) even when macroscopic cavities of the second joining location need to be filled with the liquefied material.
- Depending on the form of the two joining locations, the liquefied material may allow adjustments of the relative position of the two device parts during the joining process, which makes it possible to in situ adapt the relative position of the two device parts to the implant site. Larger such in situ adaptation is made possible, if at least one of the joining locations is designed such that it allows joining of the two parts in a selected one of a plurality 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 positioned and possibly fixed in the tissue, the two parts are positioned relative to each other such that their joining locations are in contact with each other and then the mechanical vibration is applied to either one of the parts for joining the two parts by liquefying the liquefiable material of the first joining location, by making it to penetrate into the cavity or cavities or between and under the protrusion or protrusions of the second joining location and letting it re-solidify there. The mechanical vibration used for joining the device parts has e.g. a frequency of 2 to 200 kHz and is preferably ultrasonic vibration.
- For fixing the device parts to the tissue per se known methods, such as e.g. screwing, clamping, pinning, cementing, suturing or press-fitting are applicable. According to preferred embodiments of the method according to the invention the application of mechanical vibration is used not only for joining the two device parts together but also for fixing one or both of the device parts in the tissue by anchoring it in the tissue (in particular in bone tissue) with the aid of a liquefiable material. The two applications of mechanical vibration may be carried out simultaneously and using the same contact location and the same vibrating tool and/or in succession and using different contact locations and the same tool or different tools.
- Devices to be anchored in tissue, in particular in bone tissue, with the aid of a liquefiable material and mechanical vibration and methods for implanting such devices are described in the publications WO 2002/069817, WO 2004/017857 or WO 2005/079696, the disclosure of these publications being enclosed herein by reference.
- Experiments show that successful anchorage effected simultaneously with the joining is easily effected for the device part to which the vibration is applied, and anchorage effected before the joining is easier conserved when the subsequent vibration for the joining process is not applied to the anchored device part. These findings are due to the fact that transmission of the vibration through the joining locations being in contact with each other is hardly possible as the liquefiable material being present where the two joining locations are in contact is liquefied substantially immediately on application of the vibration such that hardly any vibrational energy can be transmitted through the joining locations. This means that beyond the joining locations hardly any liquefaction by mechanical vibration occurs and therefore neither anchorage in tissue with the aid of liquefiable material and mechanical vibration nor damaging such anchorage can be effected.
- In the present text the term “liquefiable material” is used for a material comprised by the device which material can be liquefied by mechanical vibration, e.g. by ultrasonic vibration. If the liquefiable material is to take over load-bearing functions and/or if only a very limited amount thereof at predetermined locations is to be liquefied, the liquefiable material is a material in which the mechanical vibration causes no internal stress strong enough for plastifying or liquefying the material but on whose surface such liquefaction can be effected by contact with a non-vibrating element, wherein such contact is limited to points or lines (energy directors). Such materials are materials having thermoplastic properties and an elasticity module of at least 0.5 GPa. If the liquefiable material is not to have a load-bearing function and/or if more of the material is to be liquefied by the mechanical vibration, the liquefiable material may be a material as above described but may also be a material with thermoplastic properties and with a smaller elasticity module.
- In the present text the term “non-liquefiable material” is used for an additional material comprised by the device. In the non-liquefiable material mechanical vibration, e.g. ultrasonic vibration, as used for liquefaction of the liquefiable material, causes no internal stress which is strong enough for liquefying the material nor is such vibration able to liquefy the non-liquefiable material in surface areas being in contact with a non-vibrating element even if such contact is limited to single points or lines (energy directors).
- From the above follows that the properties of the non-liquefiable material of a specific device depend on the properties of the liquefiable material of the same device. Generally speaking: the less vibrational energy is used for liquefaction of enough of the liquefiable material, the easier liquefiable the non-liquefiable material may be. Therefore a thermoplastic material with a high melting temperature (e.g. PEEK) is suitable to be used as non-liquefiable material if the liquefiable material is e.g. PLLA. On the other hand the same thermoplastiv material (e.g. PEEK) is suitable as liquefiable material if the non-liquefiable material is e.g. titanium or a ceramic material.
- In the present text the term “mechanically stable oscillator” is used for a body which is able to be vibrated by e.g. ultrasonic vibration without being internally affected by the vibration. A mechanically stable oscillator comprises no form element which is deformed by the vibration, it comprises no material with a high damping loss (e.g. elasticity module considerably less than 0.5 GPa) and, if it comprises more than one part, the parts are joined such that vibration passes through the joint substantially without loss or reflection.
- In the present text the terms “bone tissue” or “bone” are used to encompass not only viable bone tissue but also bone replacement material.
- The invention comprises aspects A to E as detailed below.
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- Aspect A: The first device part forms a base in bone tissue for the second device part. The base part is equipped for being anchored in bone tissue with the aid of a liquefiable material and mechanical vibration and preferably comprises the first joining location. A distal end of the second device part (based part), is to be fixed to the bone tissue via the base part and preferably comprises the second joining location. The base part is anchored in the bone tissue by mechanical vibration and the based part is joined to the base part again by mechanical vibration. Depending on the specific design of base part and based part, anchorage of the base part in the bone tissue and joining of the based part thereto are carried out in two successive steps, wherein the vibration is first applied to the base part and then to the based part, or in one step, wherein the vibration is applied to the base part.
- Aspect B: The first device part is again a base part equipped for being anchored in bone tissue with the aid of a liquefiable material and mechanical vibration. The base part is pin-, plate- or possibly wedge-shaped and preferably comprises the first joining location, the based part (second device part) preferably comprising the second joining location. For fixing the device to bone tissue, the based part is positioned relative to the bone tissue, its joining location facing the bone tissue. The base element is then pushed between the bone tissue and the based part and simultaneously mechanical vibration is applied to its proximal end, such that on one of its lateral sides the base part is anchored in the bone tissue and on an opposite lateral side it is joined to the based part, thereby fixing the based part relative to the bone tissue. A similar method can be used for fixing instead of a device part (based part) to bone tissue, a device part to another device part or a bone tissue part to another bone tissue part (e.g. bone fragments).
- Aspect C: The first device part is again a preferably pin- or plate-shaped base part equipped for being anchored in bone tissue with the aid of a liquefiable material and mechanical vibration and preferably comprising the first joining location, the second device part (based part) preferably comprising the second joining location. A tunnel is provided in the bone tissue, the second device part is positioned adjoining a distal tunnel mouth and the base part is brought through the proximal tunnel mouth into the tunnel and at the distal tunnel mouth in contact with the joining location of the based part. Base part and based part are then joined together in the region of the distal tunnel mouth by applying mechanical vibration to the base part near the proximal tunnel mouth, wherein simultaneously with the joining of the two device parts, the base part is anchored in the bone tissue of the tunnel walls. The base part may be fixed to the bone tissue by other means than anchorage with the aid of a liquefiable material and mechanical vibration. Instead of in bone tissue, the tunnel may also be provided in a further device part.
- Aspect D: a plurality of device parts is pre-assembled such that the device parts are movable relative to each other in a limited way. Selected ones of the device parts may be equipped for being anchored in bone tissue with the aid of a liquefiable material and mechanical vibration. The device parts are brought to the implantation site in a pre-assembled configuration or are pre-assembled in the implantation site. In the pre-assembly specific ones of the device parts are still moveable relative to each other in a limited manner. The pre-assembled device parts are positioned relative to each other in a site-specific arrangement by moving the specific device parts relative to each other. The device parts are then locked in this site-specific configuration by being joined to each other with the aid of mechanical vibration, for which joining, adjacent and relative to each other moveable device parts are equipped with matched joining locations which face each other. Anchorage of the correspondingly equipped device parts takes place simultaneously with the joining or in a preliminary step. There may not be any anchorage of device parts in the bone tissue.
- Aspect E: a plurality of device parts is brought to the implantation site in succession either along substantially the same path or along different paths and the device parts are joined to each other in the implantation site, joining being effected using mechanical vibration being applied to at least one of the device parts. Selected ones of the device parts may be equipped for being anchored in bone tissue with the aid of a liquefiable material and mechanical vibration. The device parts, which are equipped with matched pairs of first an second joining locations where they are to be joined, are positioned relative to each other in the implantation site with matched joining locations facing each other and are then joined to each other with the aid of mechanical vibration. Anchorage of the correspondingly equipped device parts takes place simultaneously with the joining or in a preliminary step. There may not be any anchorage of device parts in the bone tissue.
- Suitable liquefiable materials for joining the parts of the device according to the invention are not biologically resorbable, whereas liquefiable materials for anchoring a part of the device in bone tissue may either be resorbable or non-resorbable.
- Suitable non-resorbable liquefiable materials for first joining locations and possibly also for the anchorage of a device part are e.g.: polyolefines (e.g. polyethylene), polyacrylates, polymethacrylates, polycarbonates, polyamides, polyesters, polyurethanes, polysulfones, liquid-crystal-polymers (LCPs), polyacetals, halogenated polymers, in particular halogenated polyolefines, polyphenylene sulphones, polysulfones, Polyaryletherketones (E.g. polyetheretherketone PEEK, available under the trade name Victrex 450G or Peek Optima from Invibo) polyethers, or corresponding copolymers and mixed polymers or composites containing said polymers and fillers or reinforcing agents such as e.g. fibers, whiskers, nanoplatelets, or nanotubes. Particularly suitable are polyamide 11 or
polyamide 12. - Suitable resorbable liquefiable materials for anchorage of a device part in bone tissue are e.g.: thermoplastic polymers based on lactic and/or gluconic acid (PLA, PLLA, PGA, PLGA etc) or polyhydroxy alkanoates (PHA), polycaprolactones (PCL), polysaccharides, polydioxanones (PD), polyanhydrides, polypeptides, trimethyl-carbonates (TMC), or corresponding copolymers, or mixed polymers, or composites containing said polymers. Particularly suitable as resorbable liquefiable materials are: poly-LDL-lactide (e.g. available from Bohringer under the trade name Resomer LR708) or poly-DL-lactide (e.g. available from Bohringer under the trade name Resomer R208), as well as corresponding copolymers and mixed polymers or composites containing said polymers and fillers or reinforcing agents such as e.g. fibers, whiskers, nanoplatelets, or nanotubes.
- The device according to the invention serves the same purposes as known implants and endoprostheses. The device serves in particular for fixing one viable tissue part to another viable tissue part, wherein the device according to the invention constitutes a fixing element, in particular a load bearing fixing element between the two tissue parts. The device may also serve for fixing an artificial element replacing a natural tissue part or an auxiliary element (e.g. auxiliary support part), wherein the device according to the invention constitutes the replacement part or auxiliary part as well as the fixing means.
- The advantage of the device and the method according to the invention is the ease of the in situ assembly, the robustness of the assembly, the character of the assembly which makes it non-reversible under physiologic conditions and the easy and little limited in situ adaptability of the assembly.
- For carrying out the method according to the invention a vibration device is used, e.g. an ultrasonic device comprising an ultrasonic transducer, a booster and a sonotrode or a sonotrode (vibrating tool) and an acoustic coupling piece (vibrating tool), wherein the sonotrode or the coupling piece is advantageously exchangeable. Preferably a set is provided which set comprises, in addition to device parts, vibrating tools with distal ends adapted to the contact locations of the device parts and proximal ends adapted to a fixation point of the vibration device or sonotrode respectively. The sets may further comprise printed or otherwise recorded instructions regarding implantation parameters such as e.g. vibration frequencies and application times suitable for the joining and possibly anchoring processes for implantation and assembly of the device parts of the set.
- Exemplary embodiments of the method and the device according to the invention are described in further detail in connection with the following Figures, wherein:
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FIGS. 1 to 7 illustrate structures of second joining locations and joints achieved by joining matched pairs of joining locations; -
FIGS. 8 to 14 show a first group of exemplary embodiments of aspect A of the invention, wherein a distal end of the based part is fixed within bone tissue via a base part, wherein the base part is anchored within an opening provided in the bone tissue, wherein the based part is fixed in or on the base part, and wherein the based part has varying functions; -
FIGS. 15 and 16 show a second group of exemplary embodiments of aspect A of the invention, wherein this group is similar to the first group but wherein the base part is anchored in the marrow space of a suitably prepared tubular bone; -
FIGS. 17 to 20 show a third group of exemplary embodiments of aspect A of the invention, for which the based part is joined to the proximal base part end which protrudes from an opening which is provided in the bone tissue and in which the base part is anchored; -
FIGS. 21 to 24 show a first group of exemplary embodiments of aspect B of the invention, wherein a based part is positioned in an opening in bone tissue with the aid of one or a plurality of base parts being pushed into the opening beside the based part; -
FIGS. 25 to 32 illustrates a second group of embodiments of aspect B of the invention, wherein a based part is fixed relative to a bone surface with the aid of one or a plurality of base parts; -
FIGS. 33 to 35 show a third group of embodiments of aspect B of the invention, wherein the based part to be fixed relative to bone tissue is a bone tissue part; -
FIGS. 36 and 37 show a fourth group of embodiments of aspect B of the invention, wherein the base part serves to fix a based part relative to a further device part; -
FIGS. 38 to 46 show a first group of embodiments of aspect C of the invention, wherein a based part is fixed relative to a bone surface by a base part which is introduced through the bone tissue beneath the bone surface to be joined to the based part and to be simultaneously anchored in the bone tissue with the aid of a liquefiable material and mechanical vibration; -
FIGS. 47 and 48 illustrate a second group of embodiments of aspect C of the invention wherein the base part is introduced through a further implant part to be joined to the based part; -
FIGS. 49 to 54 show a first group of embodiments of aspect D of the invention, wherein a pre-assembled plurality of device parts is arranged in a site-specific configuration and the device parts are then joined to each other; -
FIGS. 55 to 61 show a second group of embodiments of aspect D of the invention, wherein the device comprises, in addition to the plurality of pre-assembled or pre-assemblable device parts, a locking part for locking the pre-assembled device parts in the site-specific configuration; -
FIGS. 62 to 64 show exemplary embodiments of aspect E of the invention, wherein a plurality of device parts is assembled and joined in situ. -
FIGS. 1 to 7 illustrate exemplary embodiments of matched pairs of first and second joining locations suitable for the devices according to the invention and connections between such joining locations. The first joining location F comprises a liquefiable material and possibly energy directors E, the second joining location S comprises an undercut structure of a non-liquefiable material and possibly energy directors E. For joining the two matched joining locations, these are pressed against each other and mechanical vibration is coupled into one of the parts comprising either the first or second joining location from a side opposite the joining location. Pressure and vibration cause the liquefiable material in the region of the energy directors to liquefy and to penetrate in a liquid state into the structure of the second joining location and, on re-solidification, to form therewith a positive fit connection. - The main feature of joining two device parts comprising a matched pair of first and second joining locations using mechanical vibration is the fact that the liquefiable material of the first joining location is liquefied and penetrates in a liquid state into the structure of the second joining location which is usually undercut in the direction of the liquid flow. The resulting positive fit structures of the liquefiable material are characterized by forms which are dependent on the surface tension of the liquid state. The liquefiable material of these structures may adhere to the material of the second joining location but there is no necessity that it does.
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FIGS. 1 to 3 show as a first example of a second joining location S a foam structure e.g. consisting of a metal, e.g. titanium.FIG. 1 shows the foam structure before being penetrated by the liquefiable material,FIG. 3 shows a pin of the liquefiable material being anchored in the foam structure andFIG. 2 shows in a larger scale the interpenetration of the foam structure by the liquefiable material after re-solidification, i.e. the positive fit connection between the two. This positive fit connection which is visible inFIGS. 2 and 3 comprises in this first example structure elements of a size in the region of about 1 mm or less. A first joining location matched to the joining location as shown inFIGS. 1 to 3 comprises a liquefiable material, is adapted to the outer surface of the foam material (e.g. even) and is large enough to cover a plurality of the structure elements. The structure elements of the foam structure are able to act as a plurality of energy directors such that the first joining location does not need to be equipped with energy directors. However, the first joining location may also be constituted by a more or less pointed distal end of a pin-shaped device part, which pointed end acts as energy director. -
FIG. 4 shows in a cascade of three scales a second example of the second joining location and a positive fit connection between this second joining location and a first joining location. The illustrated second joining location is constituted by the surface of a hip joint prosthesis by S+G Implants GmbH, Lübeck, Germany. The surface structure of such implants consists of a metal (preferably titanium or a titanium alloy) and is e.g. produced by sintering a particulate material or by lost form molding. The structure elements have an average size from about 1 mm to about 2 mm. A first joining location matched to the second joining location according toFIG. 4 comprises a liquefiable material and is adapted to cover a plurality of the structure elements as discussed for the joining elements according toFIGS. 1 to 3 . If the structure elements of the second joining location are more rounded than edgy, it is advantageous to equip the matched first joining location with energy directors. - Similar structures as shown in
FIG. 4 being suitable for second joining locations may be made of trabecular metal by Zimmer, or of wire mesh as known from implants by Johnson & Johnson. Implants by Eska also have suitable surfaces. -
FIG. 5 illustrates second joining locations S comprising a more or less regular pattern of undercut openings (e.g. bores or grooves), which are manufactured or molded. In the second joining location S on the left, the mouths of the undercut openings protrude slightly from the overall surface and therewith are capable of acting as energy directors. A matched first joining location F may be completely even. The structure of the second joining location S on the left ofFIG. 5 does not comprise energy directors and therefore energy directors E are advantageously provided on the first joining location. The second joining location structures according toFIG. 5 advantageously have a size of about 1 to several mm and the first joining location covers a plurality thereof. -
FIG. 6 shows a matched pair of joining locations F and S similar to the joining locations according toFIG. 5 wherein the second joining location structure comprises undercut protrusions (e.g. heads or combs with a narrower neck region) instead of openings. These protrusions, if equipped with more or less sharp edges or points act as energy directors also. -
FIG. 7 shows a last example of a matched pair of joining locations, wherein the structure of the second joining location S, which is again an undercut opening, is larger than the first joining location F. The first joining location is situated at a distal end of a pin-shaped part, which pin-shaped part is introduced into the opening, when the parts to be joined are pressed against each other. The distal end of the pin is e.g. pointed for being capable of acting as energy director and the pin comprises enough of the liquefiable material for filling the undercut opening constituting the second joining location. -
FIGS. 8 to 14 illustrate a first group of embodiments of aspect A of the invention and applications thereof. The device is an implant or an endoprosthesis and comprises a base part (first device part) and a based part (second device part), the based part being based in the bone tissue via the base part by being joined to the base part. The base part is adapted to fit into an opening to be provided in bone tissue and it is equipped for being anchored in this opening with the aid of a first liquefiable material and mechanical vibration. For this purpose it comprises the liquefiable material at least in surface areas to be in contact with the bone tissue or the liquefiable material is provided inside the base part and for the anchorage is pressed through openings to surfaces in contact with the bone tissue. The base part further comprises preferably on its proximal side one of the joining locations, preferably the first joining location. The based part comprises a distal end adapted to be joined to the base part and comprising one of the joining locations, preferably the second joining location. -
FIG. 8 shows an anchor for e.g. anchoring asuture 21 or wire or other flexible device part relative to bone tissue. The anchor comprises a base part 1 (first device part) to be retained in an opening of bone tissue and a based part 2 (second device part), whose distal end is equipped for being retained in thebase part 1 and whose proximal end is equipped for holding the suture or wire (further device part). Thebase part 1 is equipped for being anchored in hard tissue, in particular in bone tissue, with the aid of a liquefiable material and mechanical vibration and it comprises the first joininglocation 3. At least part of the outer surface of thebase part 1 comprises a liquefiable material and possibly energy directors in form of ribs or other protrusions. The proximal surface of the base part is suitable for being contacted with a vibrating tool (contact location 4 for application of mechanical vibration for anchoring the base part in the bone tissue). Thebase part 1 further comprises anopening 5 extending from its proximal face towards the distal end, wherein the inner surface of theopening 5 comprises a liquefiable material and possibly energy directors (first joining location 3). Thebase part 1 consists e.g. entirely of the liquefiable material, e.g. of a thermoplastic polymer. - The based
part 2 comprises, at its distal end, the second joining location 6 (e.g. according to any ofFIGS. 1 to 6 ) and at its proximal end thecontact location 7 for the application of the mechanical vibration for the joining process. The basedpart 2 is e.g. made of a suitable metallic material and its distal end is matched to theopening 5 of thebase part 1. The second joininglocation 6 comprises e.g. undercut cavities and possibly energy directors (e.g. axial ribs). - For implanting and assembling the device comprising the
base part 1, the basedpart 2 and possibly thesuture 21 or wire, thebase part 1 is e.g. positioned in abore 10 provided in thebone tissue 11 and a vibrating tool 12 (vibrating tool for the anchoring process, e.g. sonotrode of an ultrasonic device) with a distal face being adapted to the proximal face (contact location 4) of thebase part 1 is pressed against this proximal face. Caused by the action of vibration and pressure, the liquefiable material in contact with the bone tissue is liquefied and interpenetrates the porous structure of the bone tissue to form the desired anchorage of thebase part 1 on re-solidification. Due to the high elasticity module of the base part material and due to the energy directors on its outer surface or on the bone surface, the base part material is only liquefied on this outer surface, the body of the base part keeping all its mechanical stability and strength such that the base part is able to function as a mechanically stable oscillator during the whole application of the mechanical vibration. - When the
base part 1 is anchored in thebone tissue 11, at least the distal end of the basedpart 2 is introduced in theopening 5 of the base part and a further vibrating tool 15 (vibrating tool for the joining process) with a distal face being adapted to thecontact location 7 of the basedpart 2 is applied to the based part. Application ofmechanical vibration 1 liquefies the liquefiable material of the first joininglocation 3 in theopening 5 of the base part and makes it to fill the undercut cavities provided in the second joininglocation 6 to form a positive fit connection with the first joininglocation 3 of the base part and thereby joining the basedpart 2 to thebase part 1. - The based
part 2 may have various functions which are different from the function illustrated inFIG. 8 (suture or wire anchor), for which functions the proximal end of the based part is correspondingly adapted. Exemplary further functions of the basedpart 2 are fixation of soft or further hard tissue relative to the bone tissue, fixation of a rod, a rod clamp as used in spinal fusion or external fixation, of a supporting plate as used for osteosynthesis purposes or of another auxiliary device as for anchoring e.g. a tracker for navigation. For such fixation purposes the proximal end of the basedpart 2 may e.g. be equipped with an outer or inner thread. Thebase part 1 and the basedpart 2 together may also constitute a dental implant to which a further dental prosthesis part is to be fixed. - The main advantage of the two-part device according to
FIG. 8 over a corresponding one-part implant being anchored in the bone tissue with the aid of a liquefiable material and mechanical vibration is the fact, that the based part has at least a limited adjustability when the base part is already definitively set in the bone tissue. Liquefaction of the material surrounding theopening 5, allows to force the based part into a desired position and orientation relative to the base part which may not exactly correspond with theoriginal opening 5. Furthermore, a round or polygon form of the cross section of theopening 5 and the distal end of the basedpart 2 allows to select a desired one of a plurality of possible rotational positions of the based part relative to the base part. A further advantage of the embodiment according toFIG. 8 is the fact that both device parts can be made of one material only (no multi-material parts to be manufactured), wherein the high strength material needed for fixing a further device part is suitable also for the second joining location. - Device and method as illustrated in
FIG. 8 may be altered in various ways, resulting e.g. in the following further embodiments: -
- The base part comprises a core made of a non-liquefiable material, which core carries the liquefiable material for anchoring the base part in the bone tissue on its outer surface and which core comprises an opening constituting the second joining location (the core material being e.g. a sintered material presenting in the opening 5 a porous surface to be interpenetrated by the liquefiable material of the first joining location, pair of matched joining locations according to e.g.
FIG. 4 ), and the based part comprises at least in the region of its distal end this liquefiable material constituting the first joining location (see alsoFIG. 9 ). - The base part is made of a non-liquefiable material and comprises passages connecting the
opening 5 with the outer surface and a liquefiable material is provided in theopening 5. For anchoring the base part in the bone tissue, mechanical vibration and pressure are applied to the liquefiable material in theopening 5 for pressing it partly through the passages and into the bone tissue, the liquefiable material remaining in theopening 5 constituting the first joining location (seeFIG. 11 ). - The base part consists entirely of a non-liquefiable material and is fixed in the bone tissue e.g. by comprising a thread and by being screwed into the bone tissue. The base part is equipped with the second joining location (e.g. according to
FIG. 7 ) and the based part is equipped with the first joining location. - Instead of an
opening 5, the base part comprises a proximal protrusion corresponding to an opening in the based part where the joining locations are provided (seeFIG. 14 ).
- The base part comprises a core made of a non-liquefiable material, which core carries the liquefiable material for anchoring the base part in the bone tissue on its outer surface and which core comprises an opening constituting the second joining location (the core material being e.g. a sintered material presenting in the opening 5 a porous surface to be interpenetrated by the liquefiable material of the first joining location, pair of matched joining locations according to e.g.
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FIG. 9 shows a further exemplary embodiment of aspect A of the invention. The device is suitable for being implanted and assembled with the method as shown inFIG. 1 . Thebase part 1 comprises acore 22 of a non-liquefiable material, whichcore 22 carries on its outer surface the liquefiable material for anchoring thebase part 1 in the bone tissue, and it further comprises anopening 5 extending from the proximal face towards the distal end of the base part and constituting the second joining location (according toFIG. 7 ). Thisopening 5 is a bore with an enlarged bottom region serving as undercut cavity for the positive fit connection with the basedpart 2 but also for snapping the based part in before the joining process. - Two versions 2.1 and 2.2 of the based part are shown, wherein both versions consist of the liquefiable material and comprise a distal end being equipped for being snapped into the enlarged bottom region of the
opening 5. Version 2.1 of the based part comprises agroove 25 running across its distal face and possibly carrying on along the lateral surface of the based part to its proximal face. Thegroove 25 is shaped to be capable of guiding asuture 21, such that when the basedpart 2 is snapped into thebase part 1, thesuture 21 can be moved along the groove e.g. for being tightened. On joining the based part 2.1 to thebase part 1, the material around thegroove 25 is liquefied and on re-solidification the basedpart 2 is joined to the base part and at the same time thesuture 21 is fixed in thegroove 25. - Version 2.2 of the based part comprises a
suture 21 being fixed to it, e.g. by being positioned in the mold in which the based part is produced by injection molding. For enabling adjustment of the position of thesuture 21 relative to the anchoredbase part 1, the based part 2.1 or 2.2 has e.g. a round cross section and can be rotated in theopening 5 when being snapped into the latter. -
FIG. 10 shows a further exemplary embodiment of aspect A of the invention. The illustrated device again serves as a suture anchor and again comprises abase part 1 and a basedpart 2 and is implanted according to the method as shown inFIG. 8 . Basedpart 2 andbase part 1 are adapted to each other such that the basedpart 2 can be snapped into theopening 5 of thebase part 1 in at least two different depths. A first end of thesuture 21 is e.g. fixed in the basedpart 2 and a second end of thesuture 21 is threaded e.g. throughsoft tissue 27 and then throughbores base part 1 and basedpart 2 and being aligned to each other when the based part is clicked into the base part in its outermost clicking position. When the second suture end is fixed in any suitable position, the suture tension can be increased by pressing the basedpart 2 into a deeper snap position. The basedpart 2 together with thesuture 21 is then fixed in the base part by applying the mechanical vibration to the proximal face of the basedpart 2. -
FIG. 11 shows a further application of a device according to aspect A of the invention. The device serves e.g. for fixing soft tissue (e.g. ligament or tendon 31) relative to thebone tissue 11 in which the basedpart 2 is fixed via thebase part 1. - The
base part 1 comprises a perforated sleeve 1.1 comprising on its inside surface energy directors and consisting of a non liquefiable material and an insert 1.2 of a liquefiable material which is positioned in the sleeve 1.1. The sleeve is positioned in anopening 10 which is provided in thebone tissue 11 and is pressed into the sleeve and vibrated by a first vibratingtool 12 positioned against the proximal face of the insert 1.2. The insert material is thereby liquefied and pressed through the sleeve perforations into thebone tissue 11 of the wall of opening 10 such anchoring thebase part 1 in the bone tissue. The rest of the insert in the sleeve constitutes the first joining location. - The based
part 2 consists of a non-liquefiable material and comprises ahead 30 for being retained in a tendon orligament 31 through which the distal end of the basedpart 2 is pushed before it is joined to the base part. The distal end of the based part constitutes the second joining location by comprising a head which is preferably pointed (energy director). For joining the based part to the base part, a further vibratingtool 15 or the same one (12) as for anchoring is positioned against thehead 30. -
FIG. 12 shows very schematically a further device according to aspect A of the invention, which device is applicable for fixing e.g. a ligament ortendon 31 to bone tissue. The device is equipped similar to the devices as illustrated inFIG. 8, 9 or 11 . Other than shown in the named Figs. though, thebase part 1 of the device according toFIG. 12 is capable to accommodate more than one basedpart 2 of which only one is illustrated. Thebase part 1 may have any suitable form, e.g. substantially round or substantially rectangular. The basedpart 2 shown inFIG. 12 comprises barbs which are able to preliminarily retain the basedpart 2 in thecorresponding opening 5. It is advantageous to first position and preliminarily retain all basedparts 2 in theircorresponding openings 5 in the anchoredbase part 1 and only then to finally join all basedparts 2 to thebase part 1 with the aid of the mechanical vibration being applied to thehead 30 of each one of the based parts. The barbs may also constitute the structure of the second joining location (second joining location according toFIG. 6 ). -
FIG. 13 shows a device according to aspect A of the invention, in which the basedpart 2 is asuture 21 and which enables anchorage of the substantially pin-shapedbase part 1 and joining ofbase part 1 and suture 21 (based part 2) simultaneously. - The base part e.g. consists of the liquefiable material and the regions in which it is anchored in the bone tissue are substantially the same as the first joining locations, namely the lateral surfaces of the base part. The
suture 21 consists of a non-liquefiable material. It is wound and possibly knotted round thebase part 1 for which a groove may be provided on the base part, in particular for passing the suture from the lateral sides of the base part to the proximal face thereof (groove 32). Thebase part 1 and the suture (based part 2) are together introduced into a corresponding opening provided in the bone tissue and the mechanical vibration is applied to the proximal end of the base part, whereby thebase part 1 is anchored in the bone tissue on its distal and lateral sides and at the same time thesuture 21 is joined to thebase part 1. -
FIG. 14 illustrates a further application of a two part device to be implanted e.g. according to the method as illustrated inFIG. 8 . The application concerns resurfacing of a bone or cartilage surface constituting a bearing surface in a joint.FIG. 14 illustrates resurfacing of a femoral head, the application may however in the same manner concern a cup-like structure. Such resurfacing implants replace primarily the destroyed cartilage layer but try to spear most of the underlying bone structure. Comparable approaches can be used for almost all joints in the human skeleton, being convex, concave, flat or of a multi-curvature geometry. -
FIG. 14 also illustrates an embodiment of aspect A of the invention in which thebase part 1 does not comprise an opening for the distal end of the basedpart 2, but in which thebase part 1 comprises aprotrusion 39 and the basedpart 2 comprises an opening 41 adapted to the protrusion (also possible: opening on base part and protrusion on based part). This principle is adaptable as a variant to other embodiments of aspect A of the invention as described above. Furthermore,FIG. 14 illustrates abase part 1 which is not anchored in one opening provided in the bone tissue but in a plurality of such openings, which plurality of openings may be rather small (e.g. two as illustrated) or very large, i.e. being constituted by a natural or manufactured roughness of a bone surface (e.g. surface of cancellous bone). As mentioned for the feature of the base part comprising a protrusion adapted to a based part opening, the feature of the plurality of openings provided in the bone tissue for anchorage of the base part is adaptable to other ones of the above described embodiments of aspect A of the invention. - In the device according to
FIG. 14 , thebase part 1 is anchored in a plurality of openings of the correspondingly prepared femoral bone. Thebase part 1 comprises a plurality of distal projections which comprise the liquefiable material and which reach into the bone openings and are anchored therein with the aid of the liquefiable material and mechanical vibration. The proximal side of the base part is e.g. made of a metal, ceramic, or non-liquefiable polymer material and comprises aproximal protrusion 39 comprising a surface structure with undercut cavities (second joining location). The basedpart 2 comprises the bearing surface (40) replacement and opposite the bearing surface an opening 41 wherein the liquefiable material of the first joining location is situated. -
FIGS. 15 and 16 illustrate a second group of exemplary embodiments of aspect A of the invention. These embodiments differ from the above described embodiments of a first group in that the opening in the bone tissue in which thebase part 1 of the device is anchored is not an opening which is made in the bone tissue but is the marrow space of atubular bone 45. The device is e.g. an endoprosthesis replacing a joint part. -
FIG. 15 illustrates a substantiallyhollow base part 1 made e.g. of the liquefiable material (also possible: comprising core of non-liquefiable material coated at least partly with the liquefiable material) and designed for being anchored not only on the inside bone surface of thetubular bone 45 but also on its face created by removing the one end section of thetubular bone 45 which is to be replaced by the device. The bone section to be replaced is e.g. part of a smaller joint (e.g. finger joint). The proximal end of the basedpart 2 represents most of the replacement and the distal end is designed for fitting into thebase part 1 and for constituting the second joining location (e.g. according to any one ofFIG. 1 to 3, 4, 5 or 6 ). -
FIG. 16 illustrates a device according to aspect A of the invention being a hip joint prosthesis, wherein thebase part 1 constitutes the shaft of the prosthesis to be anchored in the femoral bone and the basedpart 2 is an intermediate prosthesis part, to which a further basedpart 2′ (based on the basedpart 2 which is itself based on thebase part 1, and constituting the ball section of the prosthesis). The joining locations betweenbase part 1 and basedpart 2 and between basedpart 2 and further basedpart 2′ are shown without detail. However, each matched pair of joining locations comprises a first and a second joining location and is equipped to result after application of mechanical vibration in a positive fit connection between a corresponding surface structure of the non-liquefiable material of the second joining location and the liquefiable material of the first joining location having in a liquid state penetrated the named surface structure. Advantageous second joining locations for the device according toFIG. 16 are in particular structures as shown inFIG. 4 , however structures according toFIG. 1 to 3 or 5 or 6 are also applicable. - It is possible also that all three or at least two of the
parts FIG. 16 are joined immediately before implantation, i.e. by the surgeon and within the sterile space and that the assembled prosthesis is anchored as one part in the marrow space of the femoral bone. -
FIGS. 17 to 20 show embodiments of a third group of exemplary embodiments of aspect A of the invention. In this group of embodiments the basedpart 2 is joined to the proximal end of at least onebase part 1, wherein this proximal end protrudes from the opening in the bone tissue in which thebase part 1 is anchored and wherein the assemblage ofbase part 1 and basedpart 2 serves for securing a further tissue (e.g. soft tissue) or a further device part and wherein the further tissue or device part is fixed relative to the bone tissue in which thebase part 1 is anchored by the assemblage of the base part proximal end and basedpart 2. Instead of the named fixing function, the based part may also serve for strengthening or stiffening the base part (FIG. 20 ). -
FIG. 17 shows a device and a corresponding implantation method according to aspect A of the invention which serve for fixing a soft tissue part (e.g. tendon or ligament 31) or a further device part (e.g. supporting plate as used for osteosynthesis purposes) relative to bone. Thebase part 1 is e.g. pin-shaped and consists of the liquefiable material. It is anchored in anopening 10 inbone tissue 11 with the aid of the liquefiable material and mechanical vibration, such that its proximal end, which is e.g. pointed, protrudes from theopening 10. The tendon orligament 31 is then pushed against the proximal end of thebase part 1 such that this proximal end penetrates through the ligament ortendon 31 which is either pre-perforated or not. The basedpart 2, which is formed as a sort of head for thebase part 1 and, on its distal side, comprises the second joining location (preferably according toFIG. 7 , pointed distal end of base part serving as energy director), is then positioned on and joined to the proximal end of thebase part 1 by applying mechanical vibration to the head-shaped basedpart 2. As shown inFIG. 17 an outer rim of the head-shaped basedpart 2 may comprise distally protruding sharp edges which, on joining the basedpart 2 to thebase part 1, are pressed into the tendon orligament 31 and serve as further means for retaining the tendon orligament 31 relative to thebone tissue 11 in which thebase part 1 is anchored. -
FIG. 18 shows the same method and similar device parts asFIG. 16 used for securing an intervertebral element 50 (further device part), e.g. an intervertebral fusion element or cage, serving for fixing two neighboring vertebral bodies relative to each other and to be secured between the two neighboringvertebral bodies 51. The positionedintervertebral element 50 is shown from a lateral side. It is positioned between thevertebral bodies 51 and then two or more than two pin-shapedbase parts 1 are anchored in the vertebral bodies above and below theintervertebral element 50. A substantially bar- or plate-shaped basedpart 2 is then joined to the proximal base part ends and moved towards theintervertebral element 50 to form together with the base parts 1 a clasp which lies against the face of theintervertebral element 50 and secures it in its position between thevertebral bodies 51. -
FIG. 19 shows a pin-shapedbase part 1 which is anchored inbone tissue 11 and comprises a proximal end projecting from the bone tissue and comprises agroove 60 into which e.g. a suture 21 (or wire or rod) can be snapped or positioned and in which thesuture 21 is then secured by joining the basedpart 2 to the proximal end of the base part 1 (matched pair of joining locations e.g. according toFIG. 5 ) -
FIG. 20 illustrates a further embodiment of aspect A of the invention, in which thebase part 1 is an assembly of a base plate 55 which is secured to the surface of a bone byanchors 56 in the bone tissue extending through openings in the base plate 55 or being fixed to the base plate side facing the bone surface. The base plate is preferably thin and in particular flexible in all directions. The basedpart 2 is a plurality of stiffeningelements 57 to be joined to the one side of base plate 55 facing away from the bone surface (proximal side). Either the base plate 55 or thestiffening elements 57 comprise the first joining location (e.g. the base plate 55), the other one the second joining location (e.g. the stiffening elements 57), which is e.g. structured according toFIG. 6 but may also be structured according to any one ofFogs 1 to 3, 4 or 5. - The flexible base plate is implanted e.g. across a bone fracture and flexibly adapted to the form of the corresponding bone surface. The implanted base plate is then stiffened preferably only locally depending on the required stabilization of the fracture by correspondingly formed and positioned stiffening elements 57 (e.g. parallel stiffening stripes distanced from each other, crosswise arranged stiffening stripes or stiffening plates). Advantageously the stiffening elements are flexible also and only the combination of base plate and stiffening element has the stiffness required for stabilizing the fracture. It may furthermore be advantageous to make the base plate from a resorbable material such that stabilizing needs to be taken over gradually by the bone in which the fracture is healing (prevention of stress shielding).
- Another or an additional advantage which can be achieved with an assembly as shown in
FIG. 20 is the fact that thepins 56 and the openings provided therefore in the base plate 55 can be covered with thestiffening elements 57. This is particularly advantageous if the assembly serves for replacing a bearing surface of a joint, e.g. of a joint socket and one plate is used as stiffening element. - It is obvious for one skilled in the art to combine features of the above described and illustrated embodiments of aspect A of the invention in different ways and therewith to create further embodiments which are still encompassed by the invention.
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FIGS. 21 to 24 illustrate a first group of embodiments of aspect B of the invention. These embodiments encompass a device comprising a basedpart 2 and at least onebase part 1 and a method for implanting the device in an opening provided in bone tissue by first positioning at least a distal end of the based part in the opening and then pushing the base part or the base parts between the bone tissue and the base part and thereby anchoring the base part in the bone tissue of the wall of the opening and simultaneously joining it to the based part. The base part preferably consists of a liquefiable material and comprises the first joining location, which joining location is situated at a lateral side of the base part. The based part comprises preferably the second joining location, which is situated at a lateral side of the based part. The base part may also comprise a core of a non-liquefiable material and be coated on one lateral side with the liquefiable material, wherein the opposite lateral side then constitutes the second joining location, the first joining location being arranged on the base part. -
FIG. 21 shows a device according to aspect B of the invention, the device being a suture anchor. The device comprises a basedpart 2 and abase part 1 which are implanted in anopening 10 provided inbone tissue 11. Thebase part 1 consists of the liquefiable material and on a lateral side comprises the first joining location. The basedpart 2 is e.g. equipped with an eyelet (positioned e.g. on its proximal end) for fixing a suture or wire consists of a non-liquefiable material and comprises on its lateral side the second joining location (e.g., as illustrated in any one ofFIG. 1 to 3 or 4, 5 , or 6). For implanting the device, the basedpart 2 is first positioned in theopening 10 provided in thebone tissue 11. Thebase part 1 is then pushed into the opening beside the basedpart 2 on the one side thereof which comprises the second joining location. This pushing is accomplished with the aid of a vibrating tool (not shown) which is applied to the proximal face of thebase part 1. Simultaneously with the pushing, mechanical vibration is coupled from the tool into the base part. Due to the pushing motion the matched pairs of first and second joining locations are brought into contact with each other and due to the mechanical vibration thebase part 1 is anchored on its one lateral side in the bone tissue of the wall of opening 10 and simultaneously joined on its other, opposite lateral side to the basedpart 2. This results in the basedpart 2 being laterally fixed relative to the bone tissue via thebase part 1 and, in particular if the base part has the shape of a wedge, also in the based part being pressed against the bone wall of theopening 10 on the side opposite the base part. - In the embodiment illustrated in
FIG. 21 , the opening comprises an undercut region at least on its one side and the basedpart 2 comprises a foot which fits into the undercut region. This design ofopening 10 and basedpart 2 serves as an additional means for retaining the basedpart 2 in theopening 10 but requires a correspondingly larger entrance to the opening, which is then filled by thebase part 1. -
FIG. 22 shows a further embodiment of aspect B of the invention, wherein the implanted device serves again as a suture anchor and makes it possible to fix thesuture 21 relative to thebone tissue 11 simultaneously with retaining the basedpart 2 with the aid ofbase part 1. Again, for implantation, the basedpart 1 is introduced in theopening 10 provided in thebone tissue 11 and thebase part 1 is then pushed between the opening wall and the based part. Other than shown inFIG. 21 , according toFIG. 22 thebase part 1 comprises the second joining location on a side opposite its being anchored in the bone tissue and thebase part 2 comprises the first joining location, wherein thesuture 21 extends across this first joining location and on liquefaction of the liquefiable material of this first joining location is immersed in this material to be retained therein when it re-solidifies. -
FIGS. 23 and 24 show embodiments of aspect B of the invention in which more than onebase part 1 is used for fixing the basedpart 2 relative to thebone tissue 11 of which a surface is visible. In both cases the proximal end of the basedpart 2 is shown to be equipped with a thread which is used for fixing a further device part to the based part. Theopening 10 in thebone tissue 11 which is provided for the implantation can in both cases be a bore with a round cross section wherein for the embodiment shown inFIG. 23 , the bore is lightly larger than a corresponding cross section of the basedpart 2, and for the embodiment as shown inFIG. 24 the bore has a same cross section as an outer cross section of the based part, wherein this outer cross section encompasses concave portions to which the shape of thebase parts 1 is adapted. -
FIGS. 25 to 32 show a second group of embodiments of aspect B of the invention, wherein the based part is positioned relative to a bone surface and the base part is pushed between the based part and the bone surface for being simultaneously anchored in the bone surface and joined to the based part. -
FIG. 25 shows as a device according to the invention a basedpart 2 whose distal end is equipped for being anchored in an opening in bone tissue with the aid of a liquefiable material and mechanical vibration. Theopening 10 provided for the based part reaches e.g. across abone fracture 65 from a first bone fragment 11.1 into a second bone fragment 11.2, wherein the basedpart 2 is dimensioned to be only anchored in the second bone fragment 11.2. The basedpart 2 further comprises aproximal head section 30 with a cross section larger than the cross section ofopening 10. Thehead section 30 and a core of the basedpart 2 are preferably made of a non-liquefiable material and the head preferably comprises a slanting under side which is equipped with a surface structure suitable as second joining location (e.g. according to any ofFIG. 1 to 3 or 4, 5 , or 6. The basedpart 2 is anchored in opening 10 and then at least one wedge-shapedbase part 1 is pushed between the bone surface of the first bone fragment 11.1 and the head section of basedpart 2. Simultaneously the based part is vibrated by a vibrating tool applied to its proximal face. During such pushing and vibration, thebase part 1 is not only on the one side joined to thehead section 30 of the basedpart 2 and on the other side anchored in the bone tissue but also the two bone fragments separated by the fracture are pulled against each other. The bone surface in which thebase part 1 is to be anchored may for such anchorage have been provided with a rough surface. -
FIGS. 26 to 31 show further embodiments of aspect B of the invention, according to which aspect at least onebase 1 part is pushed between a bone surface and a basedpart 2 while being vibrated such that the base part is simultaneously anchored in the bone tissue and joined to the based part thereby fixing the based part relative to the bone tissue. AllFIGS. 26 to 31 show applications concerning intervertebral implants replacement, wherein the intervertebral element (based part 2) and the base part or base parts are implanted e.g. from the frontal side or from a lateral side of the vertebral column. -
FIGS. 26 and 27 show an intervertebral element 50 (fusion element, e.g. cage) replacing a natural intervertebral disc and constituting the basedpart 2 of a device according to aspect B of the invention. Theintervertebral element 50 is shown positioned between two neighboring vertebral bodies 51 (FIG. 26 , left: before placement of the base parts; right: after placement of the base parts) and viewed from above (FIG. 27 ). Theintervertebral element 50 is secured relative to the twovertebral bodies 51 with the aid of e.g. two upper and twolower base parts 1 which are e.g. pin-shaped and comprise the liquefiable material for being able to be anchored in the bone tissue of the vertebral bodies and constituting the first joining location. The base parts e.g. consist fully of the liquefiable material or comprise a core of a non-liquefiable material which is at least partly coated with the liquefiable material. In the latter case the core preferably protrudes at the distal end of the base part and there comprises a sharp point or self reaming edges. - The base parts are pushed between the
vertebral body 51 and theintervertebral element 50 and are simultaneously vibrated by applying a vibrating tool to their proximal face. For allowing such pushing in of thebase parts 1 the outer cortical bone layer of the relevant regions of the frontal or lateral side of thevertebral bodies 51 is removed and theintervertebral element 50 comprises on its upper andlower face 53 correspondingchannels 54 with a ring shaped extension or other undercut structures (second joining location, visible inFIG. 27 ). On pushing and vibrating thebase part 1 between thevertebral body 51 and theintervertebral element 50 the liquefiable material of thebase part 1 is liquefied and forced into the bone tissue of thevertebral body 51 on the one side and into the ringshaped extension or other undercut structures of the channel in theintervertebral element 50. This is illustrated on the right hand side ofFIG. 26 . -
FIGS. 28 and 29 show the same application asFIGS. 26 and 27 (same view as inFIG. 26 ). According toFIG. 28 thevertebral bodies 51 are shown to also comprisechannels 54′ for introduction of thebase parts 1. The channels advantageously have an undercut cross section and the base parts have cross sections adapted to the undercut channel. According toFIG. 29 theintervertebral element 50 is equipped withregions 50′ of a porous material (e.g. a metal foam material) which can be penetrated by thebase parts 1 like the cancellous bone of the vertebral body 51 (see alsoFIG. 3 ). Therefore, it may not be necessary to providechannels 45 in theintervertebral element 50. -
FIG. 30 shows a further exemplified embodiment of aspect B of the invention and illustrates a further application of device and method regarding intervertebral disc replacement. The intervertebral element 50 (based part 2) has the form of a known intervertebral disc implant (non fusion element) and, in the present embodiment, comprises not only adisc element 70 but also an upper and alower retaining element 71 for keeping thedisc element 70 in place and to be fixed to the end plates of thevertebral bodies 51. The top ofFIG. 30 shows part of thelower retaining element 71 and one of thebase parts 1 in a lateral section of the vertebral column before introduction of thebase part 1, and below the assembled and implanted device in a section from the front side to the dorsal side. The retainingelements 71 comprise back andfront rims 72 protruding against thevertebral body 51 such that when the retainingelement 71 is positioned on the vertebral body, there is a laterally open gap 73 between the endplate of thevertebral body 51 and the retainingelement 71, into which gap thebase part 1 is to be pushed. The one side of the retainingelement 71 facing away from thedisc element 70 is further equipped with a pattern of e.g. undercut cavities for being able to function as second joining location (not shown). - The
base part 1 comprises a core of a non-liquefiable material and is partly coated with the liquefiable material, constituting the means for anchoring and the first joininglocation 6. Its distal end of the non-liquefiable material is preferably equipped with self-reamingstructures 74. The base part may in this case also comprise a perforated sleeve with the liquefiable material positioned therein, wherein the distal end of the perforated sleeve comprises the self-reaming structures (similar toFIG. 32 ). - The
intervertebral element 50 including the disc element and the retaining elements 71 (based part 2) is positioned between two neighboringvertebral bodies 51. Then upper andlower base parts 1 are introduced between the retainingparts 71 and thevertebral body 51, i.e. into gaps 73, while thebase part 1 is vibrated by application of a vibrating tool to the proximal end of it. Introduction and simultaneous self reaming, joining to the intervertebral element and anchorage in the bone tissue of the vertebral body are thereby effected. - Preferably the vibrating tool used for pressing and vibrating the
base part 1 is designed for being able to hold onebase part 1 such that it can be used not only for application of mechanical vibration and pressure to the base part but also for positioning it in the first place. -
FIG. 31 shows a further exemplary embodiment of aspect B of the invention in an application regarding vertebral disc replacement (fusion element). The device again comprises an intervertebral element 50 (based part 2) and a plurality ofbase parts 1 designed for securing the basedpart 2 relative to the bone tissue of two neighboringvertebral bodies 51. Theintervertebral element 50 is e.g. a cage-like structure of a non-liquefiable material which is filled with bone fragments or with a bone replacement material. The openings of the cage structure and the bone fragments or bone replacement material constitute the second joining locations. Thebase parts 1 are staple-shaped and are e.g. made of the liquefiable material, wherein the two distal ends of thebase part 1 are pushed between theintervertebral element 50 and the bone tissue of thevertebral body 51 and constitute on the one side the first joining location and on the other side the means for anchorage in the bone structure of the vertebral endplates. Advantageously, the staple-shapedbase part 1 has a further protruding area in its center, which is anchored in the intervertebral element on pushing thebase part 1 against theintervertebral element 50. The based part may also comprise a core of a non-liquefiable material which is at least partly coated with the liquefiable material. -
FIG. 31 shows the twovertebral bodies 51 and theintervertebral element 50 therebetween from the front side. Thebase part 1 on the right hand side is positioned for application of mechanical vibration and pressure using a vibrating tool 12 (sonotrode). Thebase part 1 on the left hand side is joined to theintervertebral element 50 and is anchored in the vertebral end plates. -
FIG. 32 shows a further embodiment of aspect B of the invention, wherein the device is to be fixed relative to a bone surface using a base part which is pushed between the bone surface and a based part of the device. Thebase part 1 of this embodiment comprises a wedge shaped sleeve comprising aninside channel 80 and openings connecting thechannel 80 with the outside surface of the sleeve (perforated sleeve). The sleeve may further comprise self-reaming teeth on the one side which is to be anchored in the bone tissue. The liquefiable material is positioned inside thechannel 80. The bone surface may be the inside surface of a tubular bone and the basedpart 2 may be a shaft of an endoprosthesis to be fixed in the marrow space of this tubular bone. Implant and bone are shown only partly inFIG. 32 . - For implantation, the
base part 2 according toFIG. 32 is positioned in the tubular bone and preliminarily retained by positioning the wedge-shapedbase part 1, which is possibly pushed whereby the self-reaming teeth are worked into the bone tissue. Thebase part 1 is then pressed further into the marrow space by applying a vibratingtool 12 to the proximal surface of the liquefiable material which due to the pressure and vibration is at least partly liquefied and pressed through the openings to anchor the implant on the one side in the bone surface and on the other side in the structure of the second joining location (e.g. according toFIG. 5 ) of the based part on the other side.FIG. 32 shows the preliminarily positioned wedge-shapedbase part 1 on the left side and the same device after application of pressure and vibration on the right side. - The
base part 1 according toFIG. 32 may comprise openings from the central channel to the surface of the sleeve only on its side facing the basedpart 2 and being anchored in the bone surface with barbs or solely with the aid of the self-reaming teeth or other suitable structures such as e.g. barbs. -
FIGS. 33 to 35 illustrate a third group of embodiments of aspect B of the invention which embodiments are similar to the first group embodiments but for which the basedpart 2 is a further bone tissue part or consists of a bone replacement material. -
FIG. 33 shows a bone-tendon graft 81 (based part 2) positioned in a tunnel or bore 10 inbone tissue 11 and fixed within the tunnel or bore viabase parts 1 which are pushed between the bone part of the bone region of the graft 81 and the bone of the tunnel or bore wall. Thereinchannels base parts 1, it may be possible to push thebase parts 1 therebetween without the need ofchannels 54 and/or 54′. It is further possible to equip the base parts as earlier shown with a core of a non-liquefiable material and self-reaming structures e.g. on a distal end thereof (as e.g. shown inFIG. 30 ). In such a case the base elements will provide channels and it is not necessary to provide them beforehand. -
FIG. 34 shows a similar application of aspect B of the invention in which a bone fragment 11.1 on one side of abone fracture 65 is fixed to a bone fragment 11.2 on the other side of the fracture via abase part 1 or a plurality thereof (in the language as used before: one bone fragment representing the basedpart 2 which is joined to thebase part 1 and the other bone fragment representing thebone tissue 11 in which the base part is anchored).Channels base parts 1 have a corresponding cross section.Such base part 1 is shown on the right hand side ofFIG. 34 . -
FIG. 35 shows a further embodiment of aspect B of the invention, wherein a basedpart 2 of bone tissue is fixed in anopening 10 inbone tissue 11 with the aid of a plurality ofbase parts 1 which are pushed between the basedpart 2 and the wall ofopening 10. Therein the basedpart 2 may consist of autologous or homologous bone tissue or of a bone replacement material and constitute a plug to fill an opening caused by harvesting bone tissue. On the other hand thebone material 11 may constitute an implant made of a bone replacement material and the plug may be made of autologous bone tissue and serve for promoting ingrowth of bone tissue into the bone replacement material. -
FIGS. 36 and 37 illustrate a further group of exemplary embodiments of aspect B of the invention, wherein abase part 1 serves for joining two basedparts base part 1 is pushed between the two based parts and at the same time vibrated for liquefaction of a liquefiable material comprised by thebase part 1 and for producing a positive fit connection between two opposite joining locations of thebase part 1 and matched joining locations on the tow basedparts -
FIG. 36 shows a further exemplified embodiment of aspect B of the invention, wherein the device comprises abase part 1 and two further implant parts (basedparts intervertebral element 50 for being implanted between twovertebral bodies 51 in order for the tow vertebral bodies to be fused together and to be spaced from each other in a predefined manner.FIG. 36 shows thebase part 1 and the basedparts - The two based
parts lower wedge 82 which wedges are equipped for being anchored in the end plates of thevertebral bodies 51 with the aid of a liquefiable material and mechanical vibration. Thewedges 82 therefore comprise e.g. aninside channel 80 originating from a proximal face and ending in a plurality of mouths on the wedge surface to face the bone tissue of the vertebral body. The wedges 82 (perforated sleeves in wedge form) are made of a non-liquefyable material and the liquefiable material is positioned in theinside channels 80 and serves for anchoring thewedges 82 in the vertebral bone tissue. - The
base part 1 to be pushed between the two basedparts inside channel 80 originating from the proximal face and ending in mouths on the surfaces to be in contact with thewedges 82, and it is made of a non-liquefiable material, the liquefiable material e.g. in form of a pin being positioned in theinside channel 80 and serving for joining thebase part 1 to the basedpart wedges 82. - The based
part wedges 82 are positioned between neighboring vertebral bodies and are anchored therein. For achieving such anchorage, mechanical vibration and pressure is applied to the pin of liquefiable material by applying a correspondingly shaped vibrating tool (not shown) to the proximal face of this pin. The wedge-shapedbase part 2 is then introduced between the basedpart wedges 40 and brought into a position in which the distance between thevertebral bodies 51 is at the desired value. Then mechanical vibration and pressure is applied to the pin of liquefiable material in theinside channel 80 of thebase part 1 by applying a correspondingly shaped vibrating tool (not shown) to the proximal face of this pin. By doing so, the liquefiable material in thebase part 1 is at least partly liquefied and pressed through the mouths facing the based part wedges 82 (first joining location) to be pressed into undercut structures provided on the based part wedges 82 (second joining location, e.g. according toFIG. 5 or 6 ). - A wedge system similar to the wedge system shown in
FIG. 36 may comprise two wedges only which both are anchored in the bone tissue of the vertebral bodies on one side and are joined to each other on an opposite side, this means an embodiment wherein the base part and the based part are substantially identical. -
FIG. 37 shows a last embodiment of aspect B of the invention. Again more then one basedpart base parts 1 which are laterally joined to the basedparts 2 and at the same time are distally anchored in the bone tissue in which corresponding openings are provided. The basedparts bone fracture 65 relative to each other. As discussed in connection withFIG. 34 thelateral channels 54 provided at lateral sides of the plate elements preferably have undercut cross sections serving a second joining locations. Thebase parts 1 comprise a cross section which corresponds to two alignedchannels 54 and are e.g. made of the liquefiable material or are coated therewith. - It is obvious for one skilled in the art to combine features of the above described and illustrated embodiments of aspect B of the invention in different ways and therewith to create further embodiments which are still encompassed by the invention.
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FIGS. 38 to 46 illustrate a first group of embodiments of aspect C of the invention, according to which a preferably pin- or plate-shapedbase part 1 comprising at its distal end a joining location and preferably being equipped for being anchored in bone tissue a its lateral sides, is positioned through a corresponding through bore in bone tissue for its distal end to be in contact with the joining location of the basedpart 2. By application of pressure and vibration to the proximal face of the base part, the base part is anchored in the bone tissue of the tunnel walls and simultaneously joined to the based part such securing the base part relative to a surface of the bone tissue. If the base part is not equipped for being anchored in the bone tissue of the tunnel wall it needs to be equipped with alternative means (e.g. a head) for being retained in the tunnel. -
FIG. 38 illustrates an exemplary embodiment of aspect C of the invention. The device is e.g. an endoprosthesis for replacement of a shoulder joint to which a bone fragment 11.1 is to be fixed. The endoprosthesis constitutes the basedpart 2 and a pin for fixing the bone fragment to the endoprosthesis is thebase part 1. The bone fragment 11.1 is the bone tissue comprising a throughopening 10. Thebase part 1 is equipped for being anchored in thebone tissue 11 of the bone fragment and preferably comprises the first joining location. Thebase part 1 is positioned through a proximal mouth of opening 10 for its distal end to get in contact with the joining location (preferably second joining location) of the basedpart 2 which is positioned against the distal mouth of the throughopening 10. By applying pressure and vibration to the proximal face of the base part, the latter is anchored in the wall of the opening and simultaneously joined to the basedpart 2, i.e. the bone fragment is fixed relative to the endoprosthesis. - If the cross section of the through
opening 10 is larger than the cross section of thebase part 1 and/or if the proximal part of the base parts does not comprise a liquefiable material, no anchorage of the base part may occur or anchorage only in the region of the distal end thereof. For such a case it is advantageous to equip thebase part 1 with a head section having a larger cross section which may be anchored on the surface of the bone fragment in the region of the proximal mouth of the throughopening 10. - The shoulder joint endoprosthesis (based part 2) as shown in
FIG. 38 e.g. consists of a non-liqiefiable material such as titanium or a titanium alloy and is fixed in a correspondingly preparedtubular bone 45 using a known method such as e.g. cementing. The endoprosthesis is preferably equipped with the second joining location, e.g. a surface area with a structure as shown e.g. in any ofFIG. 1 to 3, 4, 5 or 6 . Thebase part 1 advantageously consists completely of the liquefiable material or comprises a non-liquefiable core being coated with the liquefiable material at least in surface areas serving as first joining location (distal end) and surface areas for anchoring the base part in bone tissue with the aid of the liquefiable material and mechanical vibration (lateral and/or proximal area). - For implanting the device according to
FIG. 38 , a throughopening 10 is bored through the bone fragment 11.1. The fragment is then positioned against the endoprosthesis and possibly fixed temporarily using a clamp or glue. The base part is then positioned in theopening 10, its proximal end advantageously protruding therefrom. Mechanical vibration and pressure are then applied to the proximal face of the base part using e.g. a sonotrode with a distal face adapted to the proximal face of the base part. Due to liquefaction of the liquefiable material of the base part, the latter is simultaneously joined to the endoprosthesis and anchored in the bone tissue of the bone fragment 11.1. - The method as illustrated in
FIG. 38 may be changed in various ways which leads to further embodiments of aspect C of the invention, such as e.g.: -
- The based part 2 (shoulder prosthesis) is equipped with the first joining location, e.g. carries a coat of the liquefiable material in surface areas to which bone fragments are likely to be fixed and the pin-shaped
base part 1 is equipped with the second joining location, i.e. comprises in the area of its distal end a non-liquefiable material and preferably one undercut cavity or protrusion (e.g. according toFIG. 7 ). - The bone fragment 11.1 consists not of natural bone material but is a piece of bone replacement material having a similar porous structure as bone tissue which porous structure is suitable for being penetrated by the liquefied material of the base part.
- The
base part 1 may be designed to be a protrusion of the endoprosthesis and is anchored in the bone fragment by applying pressure and vibration to the bone fragment.
- The based part 2 (shoulder prosthesis) is equipped with the first joining location, e.g. carries a coat of the liquefiable material in surface areas to which bone fragments are likely to be fixed and the pin-shaped
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FIG. 39 illustrates a intervertebral element 50 (intervertebral fusion element, based part 2) positioned between twovertebral bodies 51 and comprising a lateral or frontal region of a porous material, e.g. a metal foam material (second joining location according toFIGS. 1 to 3 ). Theintervertebral element 50 is secured between the vertebral bodies by two pin- or plate-shapedbase parts 1 which are secured in the through openings 10 (tunnels) extending through the bone tissue of the vertebral bodies and are anchored therein and in the porous region of the intervertebral element (upper base part shown before application of pressure and vibration; lower base part shown after application of pressure and vibration). -
FIG. 40 shows an endoprosthesis (based part 2) suitable for resurfacing a concave bearing surface in a joint. The endoprosthesis is fixed relative to the bone with the aid ofbase parts 1 which extend through openings in the bone tissue and are joined to an inner layer of the endoprosthesis which consists e.g. of a metal foam material (second joining locations according toFIGS. 1 to 3 ). For better anchorage of the base part on the bone tissue it is advantageous to design the base part with a shoulder and the opening through the bone tissue with a corresponding step. - An endoprosthesis similar to the one shown in
FIG. 40 may also replace a convex bearing surface of a joint. -
FIG. 41 illustrates a device for resurfacing of a facet joint according to aspect C of the invention. On the left ofFIG. 41 the joint is shown in section with the bearing surface portions removed from the prosessus articularis inferior and superior 83. In the middle ofFIG. 41 the bearing surface replacement parts (based parts 2) are shown in the same section, wherein the replacement parts comprise a porous inner section (metal foam constituting a second joining location as illustrated inFIGS. 1 to 3 ) and a full bodied outer layer constituting the bearing surface and wherein the replacement parts are fixed by pin-shapedbase parts 1 which extend in openings extending through the bone tissue from dorsal sides of the processi articulares to the inner surface of the replacement parts (based parts 2) and are joined to the replacement part and preferably anchored in the bone tissue. Thebase parts 1 comprise a shoulder that is designed to reach the bone surface when the base part is pushed into the through opening and is able to be anchored in this bone surface or form a head protruding from the bone surface. On the right ofFIG. 41 , the implanted endoprostheses are shown viewed in the direction A as indicated in the section shown in the middle ofFIG. 41 . -
FIG. 42 shows a further embodiment of aspect C of the invention. Thebase part 2 of this embodiment is a joint prosthesis for a small joint like e.g. a finger or toe joint whose short stem is retained in a corresponding cavity provided in the epiphytic bone tissue of the corresponding bone end by a plurality of preferably pin-shapedbase parts 1 which reach from opposite outside surfaces of the bone into the cavity and are laterally anchored in the bone tissue and distally joined to the implant (based part 2). Furthermore, thebase parts 1 may fill empty space between the stem of the based part and the bone tissue. The based part comprises e.g. second joining locations according toFIGS. 1 to 3 . -
FIGS. 43 to 46 show a second group of exemplary embodiments of aspect C of the invention, for which embodiments the basedpart 1 is positioned in the marrow space of atubular bone 45 and thebase part 1 reaches from the outside of the tubular bone through the bone tissue of the tubular bone wall to the based part. For anchoring the base part in the wall of the tubular bone consisting of cortical bone tissue it may be advantageous to provide suitable structures in the opening through the bone wall. -
FIG. 43 shows a marrow nail ormarrow plate 85 being fixed in themarrow space 86 of atubular bone 45 with the aid of a plurality of preferably pin-shapedbase parts 1 which preferably consist of the liquefiable material and which extend from the outside surface of thetubular bone 45 to the marrow space throughopenings 10 through the bone wall of the tubular bone to the marrow nail orplate 85. Such marrow nails orplates 85 are used for e.g. stabilizing a fracture of thetubular bone 45. - For implanting the device,
openings 10 are provided and the marrow nail orplate 85 is introduced into the marrow space and possibly preliminarily retained with suitable means. Thebase parts 1 are then introduced into theopenings 10 such that their distal end is in contact with the marrow nail or plate. Pressure and vibration applied to the proximal face of the base part results in joining the distal base part end to the marrow nail orplate 85 and possibly anchoring the base part in the bone wall of thetubular bone 45. - For embodiments as shown in
FIG. 43 it may be that a space between the based part and the bone wall of the tubular bone in the region of the through opening provided for the base part has a shape, that when filled with the liquefiable material constitutes enough geometrical retention for a second joining location (similar to the one illustrated inFIG. 7 ) such that provision of a specific surface structure serving as second joining location may not be necessary. -
FIG. 44 shows a similar embodiment asFIG. 44 . Instead of a joining location, the marrow nail orplate 85 comprises a through opening through which thebase part 1 reaches to be in contact with the opposite wall of thetubular bone 45 to which wall thebase part 1 is joined by being anchored therein. This means that in the embodiment according toFIG. 44 the opposite wall of thetubular bone 45 constitutes in the sense of the invention the basedpart 2. - Instead of a marrow nail or
marrow plate 85 as illustrated inFIGS. 43 and 44 , the based part of a similar embodiment may also be the shaft of a joint prosthesis which is to be retained in the marrow room of a tubular bone. -
FIG. 45 shows a preliminarily flexible marrow nail 85 (based part 2) having the form e.g. of a link chain comprising links which are joined to each other in an articulate manner. As detailed in connection with the previously discussed embodiments of aspect C of the invention, the chain constitutes the basedpart 2 and each chain link or connecting element between chain links comprises a joining location which is fixed relative to the tubular bone in which the chain is positioned by being joined to the distal end of a preferably pin-shapedbase part 1 reaching through the wall of thetubular bone 45 into the marrow space thereof to contact the chain. The preliminarily flexible chain can be introduced into the marrow space using considerably less room than introduction of a rigid marrow nail and when joined to thebase parts 1 represents a rigid marrow nail having sufficient mechanical strength for its function. -
FIG. 46 shows a further embodiment of aspect C of the invention. The corresponding device again serves e.g. for stabilizing bone fragments 11.1 and 11.2 of atubular bone 45 on two sides of abone fracture 65. Other than in the previously discussed embodiments of aspect C thebase part 1 and the basedpart 2 are quite similar, i.e. both are preferably pin-shaped and comprise the liquefiable material. The basedpart 2 is first introduced through anopening 10 in the bone wall such that its distal end reaches the opposite bone wall. With the aid of mechanical vibration and the liquefiable material, the basedpart 2 is anchored in theopening 10 and preferably on the inside surface of the opposite bone wall. Thebase part 1 is then introduced through acorresponding opening 10 which is positioned and oriented such that on introduction thebase part 1 meets with the basedpart 2 in the marrow space before reaching the opposite bone wall. Pressure and vibration applied to the proximal end of thebase part 1 results in anchoring the base part in theopening 10′ and on the inside surface of the opposite bone wall as well as in joining thebase part 1 to the basedpart 2 where they meet. For such joining, one of the parts is equipped with a second joining location, e.g. with a structured sleeve lining an opening in the basedpart 2 through which opening thebase part 1 is introduced on meeting the based part. -
FIGS. 47 and 48 illustrate a second group of embodiments of aspect C of the invention. In these embodiments the again preferably pin-shapedbase part 1, instead of being introduced through an opening in bone tissue, is introduced through an opening in a further device part for its distal end to be joined to the basedpart 2. - In the example as illustrated in
FIG. 47 , the further device part is e.g. aprosthetic tibia plateau 87 but may also be part of another orthopedic implant, e.g. for resurfacing another joint. Thebase part 1 serves for fixing a bone fragment (based part 2) or a corresponding piece of bone replacement material under theprosthetic tibia plateau 87, which both constitute porous non-liquefiable materials suitable for a second joining location (in the sense as e.g. illustrated inFIG. 1 to 3 or 4, 5 , or 6). Thebase part 1 preferably consists of the liquefiable material, which, with the aid of mechanical vibration coupled into the proximal end of thebase part 1, is liquefied and joined on the one hand to thebase part 2 and to the tibia plateau. For the latter purposes the openings in the tibia plateau comprise inner surfaces equipped for forming a positive fit connection with the liquefiable material when re-solidified. - The
prosthetic tibia plateau 87 is fixed in the place of the natural joint socket to be replaced using a per se known method, wherein the bone fragment (based part 2) is positioned thereunder before or after fixing the prosthetic plateau. The base part 1 (or a plurality of base parts) is positioned in the openings of thetibia plateau 87 and then mechanical vibration and pressure is applied to the proximal face of the base part. Thebase part 1 is therewith anchored in the bone fragment and simultaneously joined to thebase part 1. It is possibly not necessary to provide a bore in the bone fragment for anchoring thebase part 1 therein. - In the example as illustrated in
FIG. 48 the further device part is anintervertebral element 50 for being positioned between tovertebral bodies 51 to replace an intervertebral disc or for fusing the two intervertebral discs. The based part is in this case thevertebral body 51 adjoining theintervertebral element 50. The intervertebral element is e.g. made of a non-liquefiable material and comprises at least one through opening whose proximal mouth is accessible from a front or lateral side of the vertebral column and whose distal mouth opens towards the bone tissue of thevertebral body 51. The through opening does not have a straight axis but a bent one, wherein the angle between the proximal part of the opening and the distal part is between 110 and 160 degrees or preferably between 135 and 150 degrees. - The
intervertebral element 50 is positioned between two neighboringvertebral bodies 51. Thebase part 1 which is again preferably pin-shaped and consists of the liquefiable material is introduced into the opening in theintervertebral element 50 from the proximal mouth to the opening. It is then pressed towards the distal mouth of the opening and vibrated by a vibrating tool applied to its proximal end and therewith firstly bent to accommodate the bend in the opening and secondly anchored in the bone tissue of thevertebral body 51. The bend in theopening 10 and thebase part 1 being bent accordingly suffice as positive fit connection for retaining theintervertebral element 50 in its position between thevertebral bodies 51. - It is obvious for one skilled in the art to combine features of the above described and illustrated embodiments of aspect C of the invention in different ways and therewith to create further embodiments which are still encompassed by the invention.
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FIGS. 49 to 61 illustrate aspect D of the invention, according to which the device comprises a plurality of device parts which are pre-assembled such that they are moveable relative to each other in a limited manner, pre-assemblage being carried out in situ (in the implantation site) or ex situ. The pre-assembled device positioned in the implantation site is adapted to this site by further relative movement of the device parts to give the device a site-specific configuration which is then fixed by joining the device parts relative to each other. For this purpose the device parts are equipped with matched pairs of joining locations. The device parts are joined by pressing them against each other and by applying mechanical vibration to selected ones of them. Therein selected ones of the device parts may be further equipped for being anchored in bone tissue such representing base parts in the sense of the invention. However, this is not a condition for aspect D of the invention. -
FIGS. 51 to 54 illustrate a first group of embodiments of aspect D of the invention. In these embodiments pairs of the device parts comprise matched pairs of first and second joining locations which, for fixing the site-specific configuration of the device, are joined together by application of mechanical vibration to one device part of the pair. -
FIGS. 49 and 50 show an exemplary embodiment of aspect D of the invention. The corresponding device is a multi-part device comprising a plurality ofdevice parts 90 being pre-assembled. The device in its pre-assembled configuration (FIG. 49 top) is a flexible chain of a plurality of device parts which are arranged to form in the implanted and assembled configuration e.g. an arc- or ring-shaped device anchored e.g. in the end plate of avertebral body 51 and serving for retaining a natural or artificialintervertebral disc 50 or part thereof (FIG. 49 below: viewed from the side;FIG. 50 : viewed from above). - The
device parts 90 of the embodiment according toFIGS. 49 and 50 are all identical or quite similar and substantially all of them constitute at the same time abase part 1 and a basedpart 2. Each one of the device parts is (as base part 1) anchored in the bone tissue of thevertebral body 51 and joined to a neighboring device part (based part 2) part in preferably one only step of applying pressure and vibration. The named neighboring device part serves as base part in a following step of applying pressure and vibration. - All
device parts 90 are equipped with a first and a second joininglocation contact location 7 and with liquefiable material positioned for anchoring the device part in the bone tissue. The pairs of matched joining locations are arranged on sides of the device parts which face each other. The parts have, as shown inFIG. 49 , e.g. a trapezoidal form and the chain of device parts can be formed into a circle in which each part is in contact with and eventually joined to two neighboring device parts. - The flexible chain of preliminarily assembled
device parts 90 as shown on the top ofFIG. 49 is brought to the implantation site by e.g. minimal invasive surgery. The chain is very suitable for such surgery as it is flexible and may be realized having a much smaller cross section than the device in its implanted and finally assembled state shown in the bottom part ofFIG. 49 and inFIG. 50 . The chain is then positioned and implanted and assembled part after part.FIG. 49 (bottom) shows three positioned, implanted and assembled device parts forming an implant having the shape of an arc.FIG. 50 shows a corresponding ring-shaped device of eight device parts. - As vibrating tool for assembling the links of the chain shown in
FIG. 49 , a vibrating cable is applicable. The cable passes in the direction of the chain length through all chain links and its one end protrudes from the most distal one of the chain links. For pre-assembling the chain in a circle as illustrated inFIG. 50 , the one cable end protruding from the most distal chain link is brought near the most proximal chain link and possibly slideably fixed to the cable protruding from the most proximal chain link, to form a chain ring having a still variable form. The proximal end of the cable is connected to a vibration source (e.g. ultrasonic device) and is then pulled away from the chain ring which is held in position with suitable means. Thereby the chain ring diameter is brought to a minimum and the links are pressed against each other. This pressure and the vibration of the cable result in the links being connected to each other by the matched pairs of joining locations being joined. If the cable has a surface structure which can function as a second joining location, the cable is at the same time joined to the inside of the links and a cable ring, when separated from the proximal rest of the cable can remain in the chain to form a further device part stabilizing and strengthening the chain ring. -
FIG. 51 shows a further multi-part device according to aspect D of the invention. The device comprises fourdevice parts 90, which are pre-assembled in an articulating harmonica-like manner, wherein the device parts in the region of the articulating connections are equipped with matched pairs of first and second joining locations. The device serves e.g. for stabilizing two bone fragments 11.1 and 11.2 on either side of abone fracture 65. For implanting the device, one of the fourpre-assembled device parts 90 is fixed on either side of thefracture 65, e.g. bypins 91 which are anchored in the bone tissue of each bone fragment 11.1 and 11.2. The bone fragments or the fixed device parts respectively are then pressed against each other for closing thefracture 65 and the articulating connections between thedevice parts 90 are locked with the aid of mechanical vibration applied to each one of the connections. - It is possible to equip the
device parts 90 of the device according toFIG. 51 , which are situated nearer the bone tissue with pin-shaped protrusions facing towards the bone surface and comprising a liquefiable material. These protrusions can then be anchored in the openings in the bone tissue provided for such anchoring. Such equipped device parts then function as base parts in the sense of the earlier described aspects of the invention which base parts are simultaneously fixed to another device part (based part) and anchored in the bone tissue. -
FIGS. 52 and 53 show further embodiments of aspect D of the invention. The three-part devices comprise aplate 20, applicable in osteosynthesis e.g. for stabilizing a bone fracture, and aninsert 92 comprising with a through bore and being mounted in a through opening of theplate 20 to be capable to be oriented in different directions relative to the plate. The device further comprises apin part 93 adapted in cross section to the opening in theinsert 92. For implantation theplate 20 is positioned relative to a bone surface, the bone surface is provided with openings for the pin part by introducing a drill through the insert opening thereby orienting theinsert 92 in a site-specific way and then introducing thepin part 93 through the opening in theinsert 92 into the opening in the bone surface and applying pressure and vibration to its proximal face to firstly anchor thepin part 93 in the bone tissue and to secondly join theinsert 92 to theplate 20 to fix it in the site-specific orientation. - According to
FIG. 52 , the bowl-shaped opening reaching through theplate 20 and theinsert 92 formed as a half sphere comprise second joining locations each and thepin part 93 comprises ahead region 94 consisting of a liquefiable material which material on pressing thepin part 93 into the openings is pushed betweenplate 20 and insert 92 to constitute first joining locations on either side and to fix theinsert 92 relative to theplate 20. - According to
FIG. 53 thepin part 93 and theplate 20 comprise the liquefiable material (first joining location) and the sphere-shapedinsert 92 comprises the second joining location, preferably on surfaces facing the plate and on surfaces facing thepin part 93. - On pressing the
pin part 93 extending through the opening ininsert 92 into the opening in the bone tissue and vibrating it by applying a vibrating tool to its proximal face, the pin part is anchored in the bone tissue, the insert is joined in its site-specific orientation to theplate 20 and thepin part 93 is joined to theinsert 92. -
FIG. 54 shows a further pre-assembled device comprising a plate 20 (e.g. suitable foe osteosynthesis purposes) and means for fixing the plate relative to a bone surface. Theplate 20 comprises a non-liquefiable material and within thismaterial grooves 96 running across the plate-side facing away from the bone surface. The grooves are preferably undercut and comprise an inside surface suitable as second joining locations (e.g. rough surface, microgrooves). The means for fastening theplate 20 relative to bone tissue are staple-shapeddevice parts 97 e.g. comprising a metal wire as a core, which metal wire is at least partially coated with a liquefiable material except for the end regions where the metal core protrudes the coating and comprises cutting points or edges. The middle section of the staple-shapeddevice parts 97 has a cross section adapted to the groove cross section and a length greater than the groove length such that this middle section of the staple-shapeddevice part 97 can be snapped into one of the grooves and be pivoted therein (double arrow), such that the angle between theplate 20 and the staple-shapeddevice part 97 is freely selectable. - The arrangement of plate and pivoting staple-shaped device part constitute the pre-assembly. For fixing this pre-assembly relative to the bone surface the staple ends are forced into the bone tissue by applying pressure and mechanical vibration to the staple-shaped
device part 97. This results in anchoring the side sections of the staple in the bone tissue and in joining its middle section to theplate 20. -
FIGS. 55 to 61 illustrate a second group of embodiments of aspect D of the invention, in which the device, apart from the pre-assembly of device parts or the plurality of device parts designed for being pre-assembled, comprises at least one additional device part (locking part 100) which comprises a liquefiable material and is designed for being introduced between second joining locations facing each other in the pre-assembly of device parts. The site-specific configuration of the pre-assembled device parts is fixed by forcing the liquefiable material of the locking part (100) between the second joining locations of the pre-assembled device parts, wherein this material constitutes two opposite first joining locations matched to the second joining locations of the pre-assembled device parts. - The movement of the pre-assembled device parts relative to each other, which movement is to be blocked by the locking
part 100 is in particular a rotation and/or an axial displacement of a rod or bar (moveable part 101) in a bearing opening in abearing part 102 or formed by a plurality of bearingparts 102. Therein thebearing part 102 and/or themoveable part 102 comprise second joining locations facing each other when themovable part 101 is positioned in the bearing of thebearing part 102. The lockingpart 100 comprises the liquefiable material at a distal end. It is introduced through thebearing part 102 to contact themoveable part 101 and on application of pressure and mechanical vibration to its proximal face, the liquefiable material of its distal end is liquefied and pressed between thebearing part 102 and themoveable part 101 constituting on two opposite sides a first joining location matched to the two second joining location. On re-solidification the liquefiable material locks themoveable part 101 relative to the bearing part orparts 102. -
FIGS. 55 and 57 show the principle of the above referred to locking of a rotation and/or axial displacement of a rod (moveable part 101). The Figures are sections through bearingparts 102 andmovable part 101 in a direction perpendicular to the rotation axis. Both bearing and movable part comprise in the sense of second joining locations depressions (as e.g. illustrated inFIG. 1-3, 4, 5 or 6 ). The space between bearingpart 102 andmoveable part 101 is accessible for the lockingpart 100, e.g. by the bearingpart 102 comprising a corresponding opening leading from its outer surface to its bearing surface. -
FIG. 55 shows two bearingparts 102 being connected in any suitable manner to close the bearing surface around themoveable part 101. For locking themoveable part 101 in a desired rotation and axial position relative to the bearing parts, the lockingpart 100 is introduced into the opening of the bearing part (left hand side ofFIG. 55 ) and, by applying a vibrating tool to its proximal face, the locking part is vibrated and pressed against the surface of the movable part for the liquefiable material to be liquefied in the region of the distal end of the locking part and to be pressed between bearing parts and moveable part and into the structures serving as second joining locations (depressions). On re-solidification of the liquefiable material, rotation and/or axial displacement of themovable part 101 are prevented by the positive fit connection between themovable part 101 and the bearingparts 102 which positive fit connection is realized on opposite sides of the correspondingly shaped liquefiable material of the locking part (locked configuration: right hand side ofFIG. 55 ). - Depending on the surface structures serving as second joining locations, the
movable part 101 is locked regarding rotary and/or axial loads. Experiments using a bearing opening of 5.9 mm inner diameter and a rod 5.8 mm diameter being locked using a PLDLLA pin show good locking characteristics against axial displacement with annular grooves and against rotation with axial grooves. Good locking is achieved in both directions if the surface structure on themovable part 101 and the bearingparts 102 comprise a pattern of depressions or a combination of axial grooves or blind bores and ring-shaped grooves. - The locking principle as detailed above is achievable for axial loads only in the same manner for movable parts with other then round cross sections.
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FIG. 56 shows a further embodiment of the locking according to aspect D of the invention, which locking in this case is reversible, if the connection between the bearing parts (e.g. threaded bolts in threaded bores 103) is reversible and if the liquefiable material of the lockingpart 100 does not wet the bearing surfaces and therefore does not adhere to these on re-solidification. For achieving reversibility of the locking, the structures of the second joining locations do not constitute undercuts in the direction, in which the bearing parts are to be separated from each other or constitute only small undercuts in this direction. Such structures are e.g. axial extending grooves whose cross section extends parallel to the bolts and bores 103 into the bearing surfaces of the bearing parts (as shown inFIG. 56 ) and relatively small structures (e.g. surface roughness) on themovable part 101. Obviously circular grooves as mentioned above are suitable for a reversible locking as illustrated inFIG. 56 . - For loosening the connection between bearing
parts 102 andmovable part 101, thebolts 103 are loosened and the liquefiable material is removed to release themoveable part 101. -
FIGS. 57 to 61 show exemplary applications of the locking principle according to aspect D of the invention. -
FIGS. 57 and 58 show a rod lock application for fixing a rod (moveable part 101) to neighboringvertebral bodies 51 in order to support the vertebral column and maintain desired distances between the vertebral bodies. The rod locking device is substantially the device according toFIG. 56 , wherein the non removable bearing part is equipped with aprotrusion 105 which is e.g. equipped for the locking device to be anchored in a corresponding bore provided in the vertebral body.FIG. 57 shows the locking device closed around the rod in a larger scale andFIG. 58 shows the locking device mounted to a vertebral body. -
FIG. 59 shows an external fixation device for stabilizing the fragments of atubular bone 45 on both sides of abone fracture 65. The device comprisessupports 110 anchored with suitable means in the bone fragments and arod 111 which connects thesupports 111 to form together with them the exterior device. Betweensupports 110 androd 111double locking devices 112 are provided. A first bearing part 102.1 bears thesupport 110 and defines the axial and rotary position of the locking device relative to the support. A second bearing part 102.2 bears therod 111 and defines the axial and rotary position of the rod relative to the support. A third bearing part 102.3 bears an axel of the first bearing part 102.1 and defines an angle between the support and the rod. The whole external fixation device is pre-assembled in situ. When all parts are assembled their relative positions and orientations are locked by introducing locking parts at all locations indicated with an arrow. -
FIG. 60 shows a further application of a device which is similar to the device shown inFIG. 59 and serves for stabilizing a vertebral column and maintaining defined distanced betweenvertebral bodies 51. The supports in this case are pedicle screws. -
FIG. 61 shows in more detail a strikingly simple embodiment of a locking device according to aspect D of the invention. The device comprises a lockingpart 100, which preferably consists of the liquefiable material or is coated therewith, and which is anchored inbone tissue 11 with the aid of mechanical vibration. The lockingpart 100 comprises a shoulder on which a vibrating tool for its anchorage is applied and a protruding section of a smaller cross section. Thebearing part 102 which is preferably made of a non-liquefiable material comprises an inner bearing surface and an opening leading to this bearing surface which opening is adapted to the protruding section of the lockingpart 100. The outer surface of thebearing part 102 around the opening is equipped for constituting a second joining location 6 (e.g. as illustrated inFIG. 6 . Thebearing part 102 is preliminarily positioned on the protruding section of the lockingpart 100 and themovable part 101 is introduced in thebearing part 102. The site-specific rotary and/or axial position of the movable part is established and then the bearing part is pushed towards the bone surface and simultaneously vibrated, whereby the protruding section of the lockingpart 100 is pushed against themoveable part 101, its liquefiable material is liquefied and penetrates between themoveable part 101 and thebearing part 102 to lock these two on re-solidification. At the same time, the end of thebearing part 102 which faces the bone surface is pressed into the shoulder of the lockingpart 100 and is joined to the latter in the sense of a further pair of matched first and second joining locations. - Instead of or in addition to the above described joining of the
bearing part 102 to the lockingpart 100 via the shoulder of the locking part, it is possible also to equip the inside of the bearing part opening for the protruding section of the lockingpart 100 as second joining location and effect there a joint between the two parts. - It is obvious for one skilled in the art to combine features of the above described and illustrated embodiments of aspect D of the invention in different ways and therewith to create further embodiments which are still encompassed by the invention.
-
FIGS. 62 to 64 illustrate aspect E of the invention, according to which a plurality of device parts is brought independently to the implantation site to be joined in the implantation site to form the complete device. The device parts are equipped with matched pairs of first and second joining locations, they are positioned in the implantation site such that the joining locations of a matched pair are facing each other. The device parts are then joined to each other by being pressed against each other and by applying mechanical vibration to one of them. Therein selected ones of the device parts may be further equipped for being anchored in bone tissue with the aid of a of a liquefiable material and mechanical vibration such representing base parts in the sense of the invention. However, this is not a condition for aspect D of the invention. -
FIG. 62 shows a first exemplary embodiment of aspect D of the invention. The device is a intervertebral element 50 (fusion element, e.g. cage) to be implanted between twovertebral bodies 51. Theintervertebral element 50 comprises two halves 50.1 and 50.2, wherein each one of the halves comprises one of the joining locations of the matched pair thereof on the side where they are to be joined. The advantage of the intervertebral element according toFIG. 62 as compared with a one-piece intervertebral element is the fact that the element halves can be introduced between the vertebral bodies from dorsal-lateral sides (arrows), from where they can be pressed against each other as well. The pair of matched joining locations may be as illustrated in any one ofFIG. 1 to 3, 4, 5 , or 6. -
FIG. 63 shows a second exemplary embodiment of aspect D of the invention. The device is amarrow nail 85 or plate which comprises e.g. three device parts to be introduced into themarrow space 86 of atubular bone 45 in succession and to be assembled therein in tow joining steps. Thefirst nail part 120 comprises e.g. a core of non-liquefiable material and a coat of liquefiable material and is anchored in the cancellous bone of the bone end with the aid of the liquefiable material and mechanical vibration and on the opposite face comprises a first joining location (coat) and a second joining location (core). The second device part comprises e.g. a core of liquefiable material and a coat of non-liquefiable material and on both end faces comprises a first and second joining location. The third device part substantially corresponds to the first device part and when introduced and joined to the second device part may be anchored in the diaphysic bone tissue of the bone end. - Due to the reduced length of the device parts of the
nail 85 according toFIG. 63 compared with the complete length of the nail, a much smaller lateral opening in the bone is necessary for introducing the nail or its parts respectively than is the case for a known complete nail. -
FIG. 64 shows a modular plate (top: arrangement of fourplate modules 127 viewed from above; bottom: arrangement of twoplate modules 127 in section) according to aspect D of the invention. Theplate modules 127 are fixed to a bone surface with the aid ofpins 91 which reach through bores of two superimposed plate modules and may be anchored in the bone tissue with the aid of a liquefiable material and mechanical vibration. Each plate module comprises at least two bores. The plate modules comprise in the area of the bores for the pins on one side a first joininglocation 5 and on the other side a second joininglocation 6. This is realized e.g. by plate modules comprising a layer of a liquefiable material and a layer of a non-liquefiable material, wherein the latter layer comprises a surface structure suitable for a second joining location, as e.g. shown inFIG. 5 or 6 . - The modules are pre-arranged on the bone surface one after the other by drilling suitable openings for successive modules and positioning successive pins in the openings. When the whole plate is assembled and preliminarily fixed, the
pins 91 are driven into the bone openings by applying mechanical vibration to their proximal face and are therewith anchored in the bone tissue. At the same time theplate modules 127 are joined together to stiffen and stabilize the modular arrangement. - It is obvious for one skilled in the art to combine features of the above described and illustrated embodiments of aspect E of the invention in different ways and therewith to create further embodiments which are still encompassed by the invention.
- It is also obvious for one skilled in the art to use specific features of devices described in connection with one of the aspects of the invention in embodiments according to any other aspect of the invention.
Claims (26)
1. An intervertebral element for being implanted between two vertebral bodies in order for the two vertebral bodies to be fused together and to be spaced from each other, the intervertebral element comprising:
a first part being equipped for being positioned relative to a first one of the vertebral bodies,
and a second part being equipped for being positioned relative to a second one of the vertebral bodies,
and a further part, the further part being capable of being moved relative to the first and second parts when the first and second parts are positioned relative to the vertebral bodies, and thereby moving the first and second parts away from each other until a distance between the vertebral bodies is at a desired value,
wherein the further part is equipped for being secured relative to the first and second parts when the distance is at the desired value.
2. The intervertebral element according to claim 1 , wherein the first part or the second part or both forms/form a wedge, whereby the first and second parts are capable of being moved away from each other by the further part being pushed between the first and second parts.
3. The intervertebral element according to claim 2 , wherein the first part and the second part each are a wedge, both being capable of being positioned against the bone tissue of the vertebral bodies on one side and of lying against the further part on an opposite side.
4. The intervertebral element according to claim 3 , wherein the first part and the second part are substantially identical.
5. The intervertebral element according to claim 1 , comprising a fixation mechanism for fixing the position of the further part relative to the first and second parts when the distance is at the desired value.
6. The intervertebral element according to claim 5 , wherein the fixation mechanism is capable of fixing the further part relative to the first and second parts at different relative positions.
7. The intervertebral element according to claim 6 , wherein the different relative positions are continuously variable within a range.
8. The intervertebral element according to claim 5 , wherein the further part is capable of being fixed relative to the first and second parts by a positive-fit connection.
9. The intervertebral element according to claim 8 , wherein the further part comprises a further part inside channel originating from a proximal face and ending in at least one surface portion to be in contact with at least one of the first and second parts, the intervertebral element further comprising a material liquefiable with the aid of mechanical vibration capable of being positioned in the further part inside channel for being liquefied and being pressed into structures of the respective first/second part to yield, after re-solidification, a positive-fit connection between the further part and the respective first/second part.
10. The intervertebral element according to claim 1 , wherein at least one of the first part and of the second part is capable of being secured relative to the vertebral body by a positive-fit connection.
11. The intervertebral element according to claim 10 , wherein at least one of the first part and of the second part is capable of being anchored relative to the respective vertebral body by the positive-fit connection.
12. The intervertebral element according to claim 11 , wherein at least one of the first part and of the second part is capable of being anchored relative to the respective vertebral body by a solid material liquefiable with the aid of mechanical vibration, by pressing the liquefiable material, in a flowable state, into bone tissue of the vertebral body to anchor, whereby after re-solidification of the liquefiable material, the first/second part is anchored relative to the respective vertebral body
13. The intervertebral element according to claim 12 , wherein the first and second parts for being anchored relative to the bone tissue comprise an first/second part inside channel originating from a proximal face and ending on a surface portion to face the bone tissue of the vertebral body, the intervertebral element further comprising the material liquefiable with the aid of mechanical vibration capable of being positioned in the first/second part inside channel for being liquefied and being pressed into bone tissue of the vertebral body to anchor, after re-solidification, the first/second part relative to the respective vertebral body.
14. The intervertebral element according to claim 1 , wherein the first and second parts are made of a non-liquefiable material.
15. The intervertebral element according to claim 1 , wherein at least one of the first and second parts comprises a structured, uneven surface portion facing the further part.
16. The intervertebral element according to claim 15 , wherein the structured, uneven surface portion comprises undercut structures.
17. The intervertebral element according to claim 1 , wherein the further part is equipped for being fixed relative to the first and second parts when the distance is at the desired value, the desired value being freely and continuously adjustable in an adjustment range.
18. An intervertebral element for being implanted between two vertebral bodies in order for the two vertebral bodies to be fused together and to be spaced from each other, the intervertebral element comprising:
a first part being equipped for being anchored in a first one of the vertebral bodies,
and a second part being equipped for being anchored in a second one of the vertebral bodies,
wherein the intervertebral element forms a wedge system in which the first and second parts are capable of being distracted relative to one another by a relative movement of parts until a distance between the two vertebral bodies is at a desired value, and
wherein the first and second parts are equipped to be fixed relative to one another.
19. The intervertebral element according to claim 18 , wherein the first and second parts are equipped to be fixed relative to one another by a positive-fit connection.
20. The intervertebral element according to claim 18 , wherein the first part and the second part each are a wedge, both being capable of being anchored in the bone tissue of the vertebral bodies on one side and of being joined to the other part on an opposite side, whereby the first and second parts are capable of being distracted by being moved relative to one another.
21. The intervertebral element according to claim 18 , further comprising a wedge-shaped base part, the base part being configured to be pushed between the first and second parts to distract the first and second parts relative to one another, wherein fixing the first and second parts relative to one another comprises a connection of the first part with one side of the base part pushed between the first and second parts and a connection of the second part with an other side of the base part pushed between the first and second parts.
22. A method of implanting an intervertebral element between two vertebral bodies in order for the two vertebral bodies to be fused together and to be spaced from each other, comprising the steps of:
providing the intervertebral element, the intervertebral element comprising
a first part being equipped for being positioned relative to a first one of the vertebral bodies,
a second part being equipped for being positioned relative to a second one of the vertebral bodies,
and a further part, the further part being capable of being moved relative to the first and second parts;
positioning the first and second parts relative to the first and second vertebral bodies;
moving the further part relative to the first and second parts to distract the first and second parts relative to one another until a distance between the vertebral bodies is at a desired value; and
fixing the further part relative to the first and second parts while the distance is at the desired value.
23. The method according to claim 22 , comprising the step of anchoring the first and second parts relative to the respective vertebral body prior to the step of moving the further part relative to the first and second parts.
24. The method according to claim 23 , comprising the further step of anchoring the first and second parts relative to the respective vertebral body by a positive-fit connection.
25. The method according to claim 24 , wherein the intervertebral element comprises a material liquefiable with the aid of mechanical vibration, and wherein the step of anchoring the first and second parts comprises charging the liquefiable material with mechanical energy until it becomes liquefied, from an initially solid state, and flows into structures of the bone tissue to form, after re-solidification, a positive-fit connection with the bone tissue.
26. The method according to claim 22 , wherein the intervertebral element comprises a material liquefiable with the aid of mechanical vibration, and wherein the step of fixing the further part relative to the first and second parts comprises charging the liquefiable material with mechanical energy until it becomes liquefied, from an initially solid state, and flows into structures of at least one of the first part, the second part, the further part, to yield, after re-solidification, a positive-fit connection between the further part and the first part or the second part or the first and second parts.
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