Form shaping tool and method for implanting an implant

Abstract

A form shaping tool and kit of parts comprising an implant (1) comprising a liquifiable thermoplastic material and a form shaping tool, as well as a method for implanting, optionally fixating, an implant (1) in a recess (6) of a hard tissue (5) having at least one indentation (7) in the recess (6). The form shaping tool has a body (3) and at least one protrusion (2) for creating the indentation (7) in the sidewall of the recess (6) in the hard tissue (5).

Description

[0001] FORM SHAPING TOOL AND METHOD FOR IMPLANTING AN IMPLANT

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The current invention relates to a method for implanting an implant having thermoplastic properties in a recess of a hard tissue and a kit of parts for performing the method. BACKGROUND OF THE RELATED ART

[0004] Known embodiments of form shaping tools for fixating an implant with thermoplastic properties in a recess of an obj ect, e . g. a bone, in particular the cortical part of the bone, can lead to a recess with undesirable geometry. For example, sharp-edged and / or thin-edged geometries are generated within the recess, destabilizing it and the surrounding material, e . g. the bone tissue . Such edges may break more easily creating tissue damage and make fixation of implants with thermoplastic properties challenging as special care must be taken not to destroy any thin edges within the recess .

[0005] Moreover, known embodiments of form shaping tools for fixating an implant with thermoplastic properties in a recess of an obj ect, e . g. a bone, are configured to form indentations in the recess which do not have an optimal volume distribution or even do not allow for a convenient melting of the thermoplastic implant material in the spongy portion of the bone . For example, an outer layer of the implant may be sheared off during the insertion of the implant through the cortical bone and hence form an excess material on top of the opening through which the implantwas inserted. Such sub-optimal volume distribution is disadvantageous, as the liquifiable thermoplastic material of the implant cannot be optimally distributed within the indentations and thus no optimal adhesion to or form fit between the implant and the obj ect can be achieved.

[0006] Known methods of implanting an implant comprise a predrilling of a proximal opening in the bone surface, which is subj ect to subsequent form adaptation in the cortical tissue of the bone .

[0007] SUMMARY OF THE INVENTION

[0008] It is a task of current invention to provide a surgical form shaping tool, an alternative or improved kit of parts and an alternative or improved method for implantation of implants .

[0009] This task is solved in a first aspect by a surgical form shaping tool with the features of claim 1, in a second aspect by a kit of parts with the features of claim 3 and in further aspects by methods with the features of claims 31 to 33. Further embodiments of the surgical for shaping tool, the kit of parts, as well as the method are defined by the features of further claims .

[0010] The surgical form shaping tool according to the invention has a body with a proximal end, a distal end and a body volume, the form shaping tool further comprising at least one protrusion on the body for creating an indentation in a sidewall of a recess in a hard tissue, the protrusion having a first section and an optionally adj acent secondsection, the first section being closer to the distal end of the body than the second section, the first section being a thread configured to carve into the sidewall of the recess to form a first indentation, and the second section being a protrusion configured to shape, optionally round off, the first indentation .

[0011] As outlined below, the at least one protrusion, in particular the protrusion of the second section, can optionally have a protrusion volume that is equal to or greater than a volume of a liquifiable thermoplastic material of an implant having thermoplastic properties that can be inserted into the recess in the hard tissue .

[0012] In an embodiment of the surgical form shaping tool which may be combined with any aspects or embodiments preaddressed or to be addressed, unless in contradiction, the second section is a thread; and / or the first and second sections are sections of a continuous thread (in particular the same thread) , optionally the first section has a thinner crest than the second section and / or is V-shaped, and the second section has a wider crest than the first section and / or is rounded by a circular arc .

[0013] The kit of parts according to the invention comprises an implant having thermoplastic properties comprising a liquifiable thermoplastic material, and the form shaping tool according to any embodiment already mentioned (i . e . the surgical form shaping tool) , or a form shaping tool, wherein the form shaping tool has a body with a proximal end, a distal end and a body volume, wherein the form shaping tool further comprises at least one protrusion onthe body for creating an indentation in a sidewall of a recess in a hard tissue, wherein the at least one protrusion (in particular the protrusion of the second section of the form shaping tool) has a protrusion volume that is equal to or greater than a volume of the liquifiable thermoplastic material .

[0014] The term "implant having thermoplastic properties" refers to any obj ect (e . g. suture anchor or pin) that is suitable for implantation into another obj ect, in particular a recess in an obj ect, e . g. a bone, and having at least partial thermoplastic properties . In other words, the implant comprises a thermoplastic material which imparts thermoplastic properties such that at least a part of the implant can be liquified by energy, in particular vibrational energy applied to the implant, e . g. via a sonotrode (which may optionally be included in the kit of parts) , in particular during or after the insertion of the implant into an obj ect (e . g. a recess in the bone) , where the implant will re-solidify due to cooling . Materials having thermoplastic properties suitable for the implant as described herein are known in the art and include, e . g. , thermoplastic polymers, e . g. : resorbable or degradable polymers such as polymers based on lactic and / or glycolic acid (PL A, PLLA, PGA, PLGA etc . ) or polyhydroxy alkanoates (PHA) , polycaprolactone (PCL) , polysaccharides, polydioxanes (PD) polyanhydrides, polypeptides or corresponding copolymers or composite materials (e . g. organic or inorganic fibers or whiskers, e . g. of calcium phosphate ceramics or glasses) containing the named polymers as a component; or non-resorbable or non-degradable polymers such as polyolefines (e . g. polyethylene) , polyacrylates, polymetacrylates , polycarbonates, polyamides, polyester, polyurethanes, polysulfones, polyarylketones, polyimides, polyphenyl sulfides or liquid crystal polymers LCPs, polyacetales, halogenated polymers, in particular halogenated polyolefines, polyphenylensulf ides, polysulfones, polyethers or equivalent copolymers or composite materials containing the named polymers as a component .

[0015] The implant (e . g. suture anchor or pin) having thermoplastic properties can have any form or shape . In an embodiment, the implant can be physically held by a tip of a sonotrode and a transmission of vibrational energy from the sonotrode to the implant can take place to the extent that liquif ication of at least part of the thermoplastic components of the implant can occur by means of the vibrational energy transmitted. The implant can, e . g. , be a suture anchor or a pin which can be fixed in an obj ect . For example, the implant can be a suture anchor as described in WO 2012 / 037699, incorporated by reference in its entirety, in particular as described therein on page 2, lines 9 to 16, and pages 3, line 23 to page 4, line 23. For example, the implant as described herein for all aspects and embodiments can be a suture anchor or pin that has an overall cylindrical shape, for example the shape of a dowel . At the distal tip of this suture anchor or dowel, there may be a suture conduit or hole . The suture anchor or pin in this example features a cavity, recess, opening as described above into which a tapered tip of a sonotrode can be inserted. For example, the suture anchor may be anessentially cylindrical structure with a length of 4 mm to 20 mm, an outer diameter of 1 mm to 9 mm, and optionally with a cavity that stretches from the proximal end into the suture anchor towards the distal end over 0.5 mm to 8 mm and have a cavity diameter of 0.2 mm to 8 mm. The pin described herein may have the same dimensions as the anchor or have the following dimensions : length of 4 mm to 60 mm, outer diameter of 1 mm to 10 mm, optional cavity depth (from the proximal end into the pin towards the distal end) of 0.5 mm to 10 mm, cavity diameter 0.2 mm to 8 mm.

[0016] The implant for cortical fixation (e . g. a suture anchor or a pin) may comprise a conical section at an end, or it may entirely have a conical shape . Of course, alternatives without any conical section may be provided within the context of the present invention .

[0017] The outer circumferential surface of the implant, e . g. suture anchor or pin, may be irregular and / or, e . g. , feature protrusions, e . g. as detailed in WO 2012 / 037699. The form shaping tool has a body with a proximal end, a distal end and a body volume and comprises at least one protrusion on the body for creating an indentation in a sidewall of a recess in a hard tissue, the at least one protrusion having a protrusion volume that is equal to or greater than a volume of the liquifiable thermoplastic material of the implant .

[0018] The term "creating an indentation" , as used herein, includes that an indentation is (e . g. newly) created and / or that an (e . g. existing) indentation is worked on, e . g. by changing its shape and / or size; hence the term "creating anindentation" includes, for all aspects and embodiments, shaping an indentation.

[0019] The protrusion volume is a volume additional to the body volume, i . e . the body volume does not include the protrusion volume, and the protrusion volume does not include the body volume . The body, for example, has a regular shape and / or has essentially planar or cylindrical surfaces, for example, the body is a cylinder, a cube, a cuboid, a pyramid or a cone, and the protrusion volume is the volume of all structures extending from the surface of the body (e . g. extending from the surface of the cylinder, cube, cuboid, pyramid or cone) , in particular extending essentially perpendicular to an axis from the proximal end to the distal end of the body.

[0020] In an embodiment, the form shaping tool is configured to provide a recess with a top opening and a bottom, the recess having a total volume composed of an inner core volume and a total indentation volume, in particular threaded volume, wherein the total indentation volume, in particular threaded volume, is bigger than or equal to the volume of the liquifiable thermoplastic material of implant . In an embodiment, the total indentation volume is bigger, equal or smaller than the inner core volume .

[0021] In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, a volume of the liquifiable thermoplastic material minus the body volume is equal to or smaller than the protrusion volume .Herein, as already mentioned, the protrusion volume is a volume additional to the body volume not encompassing the body volume . The volume of the liquifiable thermoplastic material refers to the entire liquifiable thermoplastic material volume comprised within a part of the thermoplastic implant for being implanted into another obj ect, e . g. a hard tissue (e . g. bone) . In an embodiment, the volume of the liquifiable thermoplastic material refers to the entire liquifiable thermoplastic material volume comprised within the entire thermoplastic implant . In all embodiments, the liquifiable thermoplastic material may be arranged as macroscopically visible areas within the implant, or it may be dispersed, in particular microscopically dispersed within the material of the implant . In an embodiment, the determining whether the volume of the liquifiable thermoplastic material minus the body volume is equal to or smaller than the protrusion volume is performed under standard conditions, i . e . 25°C and 1 bar pressure .

[0022] The protrusion volume being smaller or equal to the volume of the liquifiable thermoplastic material allows for creating a recess with an indentation that has an indentation volume equal to or smaller than the volume of the thermoplastic material when liquified. Which in turn allows the entire liquified volume of the thermoplastic material to enter inside the indentation volume and optionally to evenly cover the surface of the indentation . In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodimentsalready mentioned or to be mentioned, at least one of the following applies :

[0023] - the form shaping tool is configured to form the recess ,

[0024] - the form shaping tool is a reamer,

[0025] - the hard tissue is a bone,

[0026] - the proximal end of the body is suitable for attaching a processing tool, in particular a drilling machine,

[0027] - the distal end of the body is suitable for forming and / or reaming the recess, and / or

[0028] a combination thereof .

[0029] In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the at least one protrusion is a thread.

[0030] For example, the thread is a continuous thread-shaped protrusion extending at least partially or entirely around the body.

[0031] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread has a volume which is constant or decreases from the proximal end to the distal end of the body .

[0032] In an embodiment of the surgical form shaping tool, in particular the total volume of all provided threads is constant or decreases from the proximal end to the distal end of the body.The thread volume is a more specific embodiment of the protrusion volume . Therefore, the thread volume is a volume additional to the body volume, i . e . the body volume does not include the thread volume, and the thread volume does not include the body volume . There will be embodiments in which the protrusion volume is composed of both a thread and some other protrusion forms, such as for example protruding rods, summing up to the protrusion volume . In an embodiment, the protrusion volume or, more specifically, the thread volume decreases from the proximal to the distal end of the body and therefor allows for creating a recess, wherein the volume of an indentation created in the sidewalls of the recess decreases in the direction from a top opening of the recess to a bottom of the recess .

[0033] In particular, a total protrusion or thread volume of the form shaping tool can increase along the direction form the proximal to the distal end of the body as some partial protrusion or thread volumes are being added in the direction to the distal end of the body. However, as the partial protrusion or thread volumes are becoming smaller in the direction to the distal end of the body, the thread volume therefore decreases from the proximal to the distal end of the body.

[0034] A form shaping tool having such a geometry is configured to generate an indentation in the sidewalls of the recess which indentation has a decreasing volume in the direction from the opening of the recess . This has the advantage that the liquifiable volume of the implant, when liquified, for example, can be distributed more easily and evenly in therecess and in particular in the indentation volume .

[0035] Moreover and for example, it can flow faster in the direction from the opening of the recess and cover a bigger surface of the indentation - allowing, e . g. , for a stronger form fit between the obj ect material, e . g. a bone, and the implant .

[0036] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread is a multiple tread, in particular a n-start thread, further in particular wherein n = 2 , 3 , or 4 .

[0037] A form shaping tool having a multiple thread (also known as multi-start thread) allows, among other things, for generating an indentation having a bigger volume compared to an indentation made by a single-thread tool . In particular, it has been found that an indentation created by a multiple thread has less sharp-edged or thin edges . A combination of these effects therefore allows both for a stronger form fit between the implant and the recess walls and also for avoiding any easily breakable sharp or thin edges within the recess . By this, the quality and simplicity of the implantation process can be increased. In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread is a clockwise or counterclockwise round thread, optionally having a thread angle of about 60° (the thread angle corresponds to theangle between two flanks, as commonly understood, whereas the flank angle noted further below corresponds to the angle between the flank of the thread and a plane perpendicular to the axis of the tool ' s body) .

[0038] It has been found that a single or a multiple round thread having a thread angle of about 60° , for example 55° to 65° , in particular 59° to 61 ° , surprisingly provides a recess with especially smooth and stable indentation edges .

[0039] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the thread (in particular the second section of the protrusion being a thread) is configured to create an indentation having a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 or less than 1.

[0040] In an embodiment, the depth to width ratio of the indentation is measured in a cross section through the form shaping tool, along an insertion direction, for example a direction of drilling . A depth to width ratio in the given ranges is reflected in an indentation having a length corresponding to double the width, being equal the width or less than the width, e . g. half of the width for a depth to width ratio of 0.5.

[0041] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread (in particular the second section of the protrusion being a thread) has at least one flank having a depth to width ratio selected from the list of :less than 2, in the range of 1 to 2 or less than 1, optionally wherein all flanks of the thread have a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 and less than 1 , and / or the thread (in particular the second section of the protrusion being a thread) has a depth to width ratio that decreases stepwise or gradually from the distal end to the proximal end of the body, in particular decreases from above 2 to less than 2, in particular within 2 to 3 revolutions of the thread around the body.

[0042] The depth to width ratio of the thread is measured in the side profile of the form shaping tool, i . e . in a cross section along an intended insertion direction, for example a direction of drilling. In particular, the measurement can be performed at the widest and the broadest part of the flank, e . g. directly at the body at which the flank is arranged for the width and the point of the flank being most remote from the body for the depth . For clarity' s sake it is noted, as commonly understood, that the thread depth refers to the distance between the crest of the thread and the root of the thread, i . e . the body of the tool, e . g. as shown in Fig. 9A. The width refers to the largest extension of the thread perpendicular to the depth, e . g. as shown in Fig. 9A. The depth and width of the indentation correspond to the above definitions, respectively, i . e . the negative form of the protrusion, e . g. thread.

[0043] In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the thread has a depth to width ratio thatdecreases stepwise or gradually (e . g. from the first to the second section, as outlined below) from the distal end to the proximal end of the body, in particular decreases from above 2 to less than 2, in particular within 2 to 3 revolutions of the thread around the body.

[0044] For example, the thread' s shape can change from a thread with a sharp or thin crest (high depth to width ratio) to a thread with a rounded crest, in particular from the distal end to the proximal end of the body. The sharp crested thread nearer to the distal end can serve as a cutting thread for creating the indentation in the recess, while the following round crested thread can round the indentation off .

[0045] In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the thread has a first section and an optionally adj acent second section, wherein the first section is closer to the distal end of the body than the second section, wherein the first section has a thinner crest than the second section and / or is V-shaped, and the second section has a wider crest than the first section and / or is rounded by a circular arc (has a crest rounded by a circular arc) .

[0046] The first section of the thread is positioned closer to the distal end than the second section. This first section comes into contact with a hard tissue first and can, e . g. create an indentation (and optionally the recess) in a recess in the hard tissue by virtue of its thinner, sharper and / or V-shaped crest . The second section follows the firstsection when the body is inserted into the hard tissue or recess and can then round off the pre-cut indentations by virtue of its rounder and / or wider crest .

[0047] The crest rounded by a circular arch refers to the circular arch connecting the flanks of the thread, as exemplified in the enclosed Figures .

[0048] The transition from the first section (e . g. cutting section) to the second section (e . g. reaming section) can happen either gradually or stepwise . In an embodiment, wherein the first section converts into the second section gradually, the thread profiles change their form in direction from the distal to the proximal end by increasingly transitioning from sharp edged crests to rounded or less sharp crests, in particular to a reaming thread with more rounded crests .

[0049] In an example, a sharp cutting V thread is arranged at and extends from the distal end of the body as a sharp cutting thread. Adj acent thereon or non-adj acent thereon (i . e . with at least one third section separating the first and the second section) , a thread having a rounded crest (e . g. a Whitworth thread) is arranged closer to the proximal end of the body.

[0050] In an embodiment of the form shaping tool which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread is a symmetrical or an asymmetrical thread, optionally wherein the first section is a trapezoidal, a V-shaped, a unified, a buttress, a square, or a sinusoidal thread; and / or the second section is a trapezoidal, a unified, a buttress, asquare, a Whitworth, a knuckle, a parabolic, or a sinusoidal thread, and / or at least a part of the thread of the second section has a rounded crest ( 12 ) , in particular a thread crest ( 12 ) rounded by a circular arc, optionally a circular arc of 2 x ( 90°-©) , wherein 0 is the flank angle of the thread. In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the thread is a symmetrical or an asymmetrical thread, optionally a trapezoidal, a V-shaped, a unified, a buttress, a square, a Whitworth, a knuckle, a parabolic, or a sinusoidal thread,

[0051] optionally at least a part of the thread, optionally the entire thread, has a V-shaped thread form and / or at least a part of the thread, optionally the entire thread, has a rounded crest, in particular a thread crest rounded by a circular arc, optionally a circular arc of 2 x (meaning two times) (90°-©) , wherein 0 is the flank angle of the thread. The flank angle is the angle formed between the flank of the thread and a line perpendicular to the body' s axis (from the distal to the proximal end) . Exemplary flank angles 0 include 20° to 35° , optionally about 30° . The circular arc is part of a circle with a radius (see, e . g. Fig. 11B) and exemplary radius values include, e . g. , 0.2 mm to 2.0 mm.

[0052] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the body of the form shaping tool has asection with an inner diameter excluding the at least one protrusion in the range of 0.8 mm to 5.0 mm or 1. 0 mm to 3.0 mm, or wherein the entire form shaping tool has an inner diameter excluding the at least one protrusion in the range of 0.8 mm to 5.0 mm or 1. 0 mm to 3.0 mm. When referring to the surgical form shaping tool as defined in claim 1, the section described in the upper paragraph does not necessarily refer to the "tool section" or the "first or second section" , but to any section or segment of the tool .

[0053] Herein, the inner diameter describes a diameter of the body without protrusion, for example without the thread. It has been found that a form shaping tool having such dimensions is well-suited for creating an indentation in a recess of a hard tissue ranging from a natural or artificial small bone of a newborn ( for example of the ear canal of a human) to a big bone of an adult ( for example of the upper leg of a human) . Depending on the type of tissue and implant, different diameters can prove to be particularly advantageous . Of course, the kit of parts can also be used for the treatment of an animal hard tissue . Depending on the type of animal and the size of the hard tissue, e . g. bone, the inner diameter of the form shaping tool can even range from 0.8 mm to 25.0 cm ( for example in the case of an elephant ' s bone) .

[0054] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the multiple thread comprises or is a n-start thread, the n-start thread having a thread pitch configured to create at least n indentations over a recess length of 0.5 mm to 10.0 mm, 0.5 mm to 8.0 mm or 1.0 mm to 5.0 mm, optionally over an angle of 360° / n.

[0055] It has been found that a form shaping tool comprising more than one thread (i . e . multithread tool) has excellent guiding and positioning properties, in particular in a hard tissue, and may guarantee optimum roundness of any indentation created by the thread.

[0056] For example, a form shaping tool comprising a single or an n-start thread may additionally comprise a self-centring cross cutting edge and other means (e . g. ground flutes) for an improved chip or dust removal .

[0057] In an embodiment of the kit of parts or form shaping tool which can be combined with any of the embodiments already mentioned or to be mentioned, the form shaping tool is a combination reamer, i . e . a combined drill and reamer, configured for performing both a drilling and reaming operation in a single pass . Such a design (e . g. including the notch and / or cutting edge as disclosed herein) eliminates the need to change tools, saving time, improving efficiency and lowering the risk of the tissue being damaged during operation .

[0058] In an embodiment of the form shaping tool, the distal end of the tool features a twist drill design, optionally with two cutting edges and flutes for chip evacuation, or a notch and / or a cutting edge, e . g. also extending further towards the proximal end. This may be the first section, as disclosed herein, and / or the distal part or end, and / or mayin particular function as a drill bit, creating the initial opening of a recess in the hard tissue . In an embodiment, the proximal end of the tool has a reamer segment (e . g. second section) , optionally larger in diameter than the drill section (e . g. first section or distal part or end) . This segment can comprise multiple cutting edges and flutes designed for reaming the recess .

[0059] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the thread has a tread pitch in the range of 0.5 mm to 3.0 mm, in particular 0. 6 mm to 2.0 mm or 0.7 mm to 1.5 mm.

[0060] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the body has a section with an outer diameter including the at least one protrusion in the range of 1.1 mm to 3.5 mm or 1.3 mm to 3.3 mm, or wherein the entire form shaping tool has an outer diameter including the at least one protrusion in the range of 1.1 mm to 3.5 mm or 1.3 mm to 3.3 mm.

[0061] For the sake of clarity, it should be noted that the outer diameter is to be understood as a diameter including the protrusion, or in a more specific embodiment, the thread, e . g. the total diameter of the body including any protrusion ( s ) . In an embodiment, the outer diameter is measured in a cross section of the form shaping tool, the cross section being parallel to the length extension of the tool . For example, in an embodiment of the kit of parts,the outer diameter refers to the largest outer diameter of the form shaping tool .

[0062] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the form shaping tool is made of steel, stainless steel, a metal or alloy, titanium, diamond, boron carbide, a plastic material, or a combination thereof .

[0063] Preferably, the material of which the form shaping tool is made is a disinfectable material, for example a material stable to a disinfecting chemical such as ethanol, or isopropanol, or optionally stable to heating over 134 °C . A sufficiently hard material with good disinfection properties and compatibility allows a quick and broad application of the product .

[0064] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, an outer diameter of the body including the at least one protrusion is constant from the proximal to the distal end of the body or is largest at the proximal end of the body, optionally wherein an outer diameter of the body including the at least one protrusion is constant or is tapered from the proximal end to the distal end of the body.

[0065] It has been found that a form shaping tool having an outer diameter being largest at the proximal end is well suitable for creating a recess with a large opening and a large indentation in the proximity of the tissue ' s surface . Sucha recess allows, e . g. , for a quick and convenient downwards directed flow of any liquid material, in particular liquified thermoplastic material, within the recess . A large opening moreover has the advantage of being easily accessible, in particular for inserting the thermoplastic implant into the recess .

[0066] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the at least one protrusion comprises or is a n-start thread, wherein the outer diameter of the body decreases along n thread circumferences, optionally wherein n = 2 , 3 , or 4 .

[0067] When referring to the at least one protrusion being a thread, said protrusion and thread may refer to the first and / or second section of the protrusion in the context of all aspects and embodiments of the surgical form shaping tool disclosed herein.

[0068] As already mentioned, a form shaping tool having a multiple thread allows, among other things, for generating an indentation having a bigger volume compared to an indentation made by a single-thread tool . In particular, it has been found by the inventor that an indentation created by a multiple thread has less sharp-edged boarders or thin edges . A combination of these effects therefore allows both for a higher mechanical load capacity within the implant, in particular its polymer, and the hard tissue and also for avoiding any sharp or thin edges which can easily break upon stress and / or tension caused by the implant insertion.Without being bound by theory, a smooth geometry with possibly large radii and a low aspect ratio of the indentation allows for avoiding mechanical stress peaks and for maximizing the supporting cross sections . In particular, a decreasing outer diameter of the body along the direction of the thread circumferences, i . e . from the proximal to the distal end of the body, makes the form shaping tool particularly suitable for forming indentations whose volume decreases along an extension length of the recess, e . g. from a top opening of the recess downwards . In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, an outer diameter of the body including the at least one protrusion is constant from the proximal to the distal end of the body or increases from the distal end to the proximal end of the body, in particular by a factor bigger than a factor by which an inner diameter of the body excluding the at least one protrusion increases from the distal end to the proximal end of the body.

[0069] A geometric design of the form shaping tool, in which the volume of the protrusion increases, in particular by a factor bigger than the volume of the body core (i . e . the body excluding the protrusion) is particularly suitable for creating a recess with a large indentation volume at a proximal end of the recess (i . e . in the proximity of the opening of the recess) compared to the indentation volume at a distal end of the recess ( for example at a bottom of the recess) . In particular, as the ratio of the protrusionvolume to the body core volume decreases in the direction from the proximal end to the distal end of the shaping tool ' s body, the proportion of the core volume is biggest at the distal end of the shaping tool ' s body. Such a shaping tool is suitable for creating a recess in which the walls of the recess and in particular of the indentation (optionally indentation at the proximal end of the recess) are effectively covered by a liquified material of the implant . Moreover, a recess created by such a tool is suitable, e . g. , for an effective accumulation of the liquified material at the bottom of the recess, in particular of the material that has not entered or adhered to the sidewall of the indentation. The form shaping tool is therefore suitable for providing a recess for a convenient or even excellent fixation of the implant .

[0070] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the form shaping tool further comprises a tool section having a diameter larger than a diameter of the body including the at least one protrusion, the tool section being arranged at the proximal end of the body and configured to widen the recess, in particular a proximal end of the recess . When referring to the surgical form shaping tool as defined in claim 1, the tool section may in particular comprise the second section of the protrusion. In an embodiment, the form shaping tool further comprises a tool section made of the same or a different material than the rest of the body, the largest diameter of which toolsection is larger than the outer diameter of the body (i . e . the diameter including the at least one protrusion, in particular the thread) . In particular, the outer diameter is measured in a cross section of the form shaping tool, the cross section being parallel to the length extension of the tool .

[0071] In an embodiment, such tool section may be an integral part of the body and be for example a one piece design, glued or welded onto the body, or it may be a two or more piece design, for example screwable or clampable onto the body. In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, at least one of the following applies :

[0072] a cone angle of the tool section is in the range of 30° to 40° , in particular 34 ° to 35° , further in particular 34.71 ° ,

[0073] the tool section has a length in direction from the proximal end to the distal end of the body in the range of 0.1 mm to 8.0 mm, in particular 1.0 mm to 5.0 mm, further in particular 1.4 mm to 3.0 mm, or

[0074] a combination thereof .

[0075] In an embodiment comprising a tool section having a diameter larger than a diameter of the body including the at least one protrusion, the cone angle of such tool section is preferably in the range of 30° to 40° . Of course, also other cone angles are possible, for example 10° to 80° , 20° to 70° , 20° to 60° , 20° to 50° , or 30° to 50° . However, it has been found that a cone angle of 30° to40° is suitable for providing a widening or an indentation inside a recess which has an optimal angle and geometry for allowing any liquified thermoplastic material to flow downwards and to form a form fit with the surface of the recess . Moreover, such a cone angle allows for loosing as little bone material as possible and the implant, for example a push-in anchor, can be positioned well and easily into the recess .

[0076] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the form shaping tool or kit of parts further comprises a tool for creating the recess in the hard tissue, optionally attached to the distal end of the form shaping tool .

[0077] In an embodiment of the form shaping tool or the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned unless in contradiction, the tool for creating the recess is selected from the group consisting of a drill, an awl, and a punching tool . Such a tool may for example be integrated in the form shaping tool or be a distinct part to be used separately or to be arranged or attached to the form shaping tool, in particular as a frontal part, e . g. a drilling or punching tip .

[0078] In an embodiment, the tool for creating the recess can be integrated in the form shaping tool . For example, a frontal part of the form shaping tool can be configured for entering into the hard tissue at first (i . e . arranged at the distal end) . For example, the shaping tool can comprisea cutting edge and / or a notch at least at its frontal part, optionally extending further in direction of the proximal end, e . g. over half or the entire part of the tool that comprises a protrusion.

[0079] In an embodiment of the form shaping tool or the kit of parts according to the present invention, which may be combined with any of the embodiments of the form shaping tool or the kit of parts preaddressed or still to be addressed unless in contradiction, the form shaping tool comprises a cutting edge, in particular at a punching or drilling tip of the body, the cutting edge being configured to form a recess in the hard tissue and / or in a hardening material .

[0080] The cutting edge and / or notch at least partially extends in direction towards the proximal end of the body. In an embodiment, the cutting edge is formed as an edge of a notch extending at least partially from the distal end of the body to the proximal end of the body, the notch being optionally formed in the body and / or the protrusion. The notch and / or cutting edge may be arranged in parallel to the axis of the body, or they may follow the axis in a helical shape or partially helical .

[0081] The notch may also be present independently of a cutting edge, e . g. to serve as room for removing material that is cut out of the obj ect into which the form shaping tool is inserted, e . g. when the form shaping tool is used to create recess or the indentation in the sidewall of the recess . In an embodiment, the notch has a volume of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% or 50% of the body' s volume . For example, microscopic damages to the surface of the formshaping tool or any other microscopic openings in the form shaping tool are typically not a "notch" according to the invention .

[0082] In an embodiment, the notch is formed in the form shaping tool ' s body and / or protrusion, i . e . a part of the form shaping tool is removed resulting in an indentation being the notch.

[0083] The cutting edge may be a blade, or any edge of the shaping tool suitable for forming a recess in the hard tissue under standard operation conditions .

[0084] The cutting edge may be provided both as an integral part of the form shaping tool, or it may be a separate part of the kit of parts, arranged at the form shaping tool when needed to provide a recess .

[0085] In an embodiment of the form shaping tool or the kit of parts according to the present invention, which may be combined with any of the embodiments of the form shaping tool or the kit of parts preaddressed or still to be addressed unless in contradiction, at least one edge delimiting the notch is the cutting edge configured to form a recess in the hard tissue or optionally the hardening material .

[0086] In an embodiment of the form shaping tool or the kit of parts according to the present invention, which may be combined with any of the embodiments of the form shaping tool or the kit of parts preaddressed or still to be addressed unless in contradiction, the form shaping tool has a through-opening extending essentially in direction from the proximal to the distal end of the body, inparticular wherein the through-opening extends through the body of the form shaping tool .

[0087] The through-opening is especially advantageous for guiding the form shaping tool to the required position for providing the recess or creating the indentation. Herein, the skilled person may combine the through opening with a means for guiding, e . g. a cannula or a K-wire by inserting and optionally passing the means inside or through the through-opening. In this way, the form shaping tool may be guided along the means for guiding to reach the desired position at the hard tissue .

[0088] In an embodiment of the form shaping tool or the kit of parts according to the present invention, which may be combined with any of the embodiments of the form shaping tool or the kit of parts preaddressed or still to be addressed unless in contradiction, the form shaping tool or the kit of parts further comprises a means for guiding the form shaping tool inside the recess, the means for guiding being configured such that it is insertable into the through-opening, in particular passable through the through-opening .

[0089] In an embodiment of the form shaping tool or the kit of parts according to the present invention, which may be combined with any of the embodiments of the form shaping tool or the kit of parts preaddressed or still to be addressed unless in contradiction, the means for guiding is an essentially rod-shaped element, in particular wire, in particular a Kirschner wire (K-wire) .In an embodiment, the tool for creating the recess in the hard tissue is made of steel, stainless steel, a metal or alloy, titanium, diamond, boron carbide, a plastic material, or a combination thereof .

[0090] Preferably, the material of which the tool for creating the recess is made is a disinfectable material, for example a material stable to a disinfecting chemical such as ethanol, or isopropanol, or optionally stable to heating over 134 °C . In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the kit of parts further comprises a tool for transferring ultrasound to the thermoplastic implant, optionally a sonotrode .

[0091] The kit of parts may further include instructions for assembly of the kit of parts and / or for the use of the kit of parts .

[0092] In an embodiment, the sonotrode is suitable for transferring vibrational energy, in particular ultrasound vibrations, to the thermoplastic implant when attached to the sonotrode, in particular sonotrode tip . Of course, the kit of parts may comprise more than one sonotrode, for example 2, 3, 4, 5, or 10 sonotrodes, selected for an application with a specific implant .

[0093] In an embodiment of the kit of parts which can be combined with any of the embodiments already mentioned or to be mentioned, the implant is a pin, an implant for tenodesis or a suture anchor, optionally wherein the kit further comprises a suture for use with the suture anchor .In an embodiment comprising a sonotrode, the implant (e . g. pin or suture anchor) may have an axially extended opening which aligns with the sonotrode into which the sonotrode tip is inserted. The interaction between the sonotrode tip and the implant is effective for transmitting a sufficient amount of vibrational energy for liquif ication of the thermoplastic components of the implant .

[0094] In an embodiment, the implant is a suture anchor that has a suture conduit at a distal end of the anchor . As described, suture anchors are known in the art and the suture anchor may, optionally, comprise a suture in a suture conduit . In an embodiment of the kit of parts according to the present invention, which may be combined with any of the embodiments of the kit of parts preaddressed or still to be addressed unless in contradiction, the kit of parts further comprises a hardening material for orthopedic use, optionally in powder or neat form. For example, the hardening material can be filled into a recess in the hard tissue into which the implant should be inserted. Before the hardening material hardens (completely) , the form shaping tool can be used to create an indentation in a sidewall of the recess filled with the hardening material and subsequently the implant can be inserted into the device while applying energy, in particular ultrasound, to at least partially liquify the implant . The liquified parts of the implant will at least partially extend into the nonhardened or partially hardened, e . g. pasty or viscous, hardening material, and thereby displace the non-hardened or partially hardened hardening material .As used herein, the term "non-hardened" refers to a state of the material before the hardening reaction has taken place / is complete, and includes the terms "partially hardened" , "pasty" and "viscous" which refer to the state of the material before the hardening reaction is complete and the material can still, e . g. , be displaced or formed. The "partially hardened" , "pasty" and "viscous" hardening material in particular refers to the hardening material in a state in which it is not (yet) hardened to a dimensionally stable material, in particular, the terms "partially hardened" , "pasty" and "viscous" refer to a hardening material having a viscosity between 10 Pas and 1000 Pas . The viscosity is measured for all embodiments and aspects disclosed herein, e . g. , at 20°C and by, for example, a controlled shear stress-shear rate rheometer (see, e . g. , M. Nehdi, S . Al Martini, Cement and Concrete Research, Volume 39, Issue 11, 2009, Pages 1007-1016) . It is preferred to insert the device into the hardening material and / or the implant into the device when the hardening material has a viscosity between 10 Pas and 200 Pas .

[0095] The hardening material of use in the present invention can be any material that is suitable for orthopedic applications and that features load bearing and / or load transferring properties when hardened. The hardening material can support or reinforce the bone material . Such hardening materials are known to the skilled person and include the materials disclosed in Liu et al . J. Funct . Biomater . 2023, 14, 134. The hardening materials for use in the present invention are preferably inorganic materials,comprise inorganic materials or are based on inorganic materials . For example, the hardening materials can be non-polymeric materials (e . g. do not comprise polymeric materials) . Preferably, the hardening materials for use in the present invention exclude materials that harden exothermically at temperatures higher than 50 °C, but rather refer to materials that harden at temperatures of up to 45°C or 50°C . The term "hardening" as used herein means that the material can harden at least to the extent that it exhibits load bearing and / or load transferring properties, and can include thixotropic materials, e . g. thixotropic gels . Exemplary thixotropic gels include gels comprising calcium-phosphate . For example, these gels can be used while ultrasound is applied to the gel, e . g. while introducing the gel into bone material, e . g. to support or reinforce trabecular structures .

[0096] Exemplary hardening materials include (optionally biodegradable) cements, hydraulic or non-hydraulic cements, e . g. Ca-based cements, e . g. calcium phosphate-based cements, or CaCOs or CaSCy-based cements, silicate-based ceramics, silicate, borate and phosphate glasses . In an example, the hardening material for use in the present invention does not comprise thermoplastic polymers . The hardening material, in particular hydraulic cements, may comprise additives which create pores in the material, such as water-soluble salts or hydrogels which swell and subsequently dissolve creating pores .

[0097] For example, hydraulic cements can be calcium phosphate based cements (CPC) . A CPC, as used herein, refers to anycement that comprises calcium phosphate and is suitable for orthopedic applications . Suitable CPCs are known in the art, and the skilled person can choose any CPC for the purposes of the present invention that is suitable for orthopedic use . For easier legibility, the word "cement" may be used herein which refers to a biodegradable, optionally hydraulic cement, in particular a CPC as mentioned above . Exemplary CPCs include calcium orthophosphate compounds such as, e . g. compounds including monocalcium phosphate monohydrate, dicalcium phosphate dihydrate, octocalcium phosphate, precipitated hydroxyapatite, calcium-deficient hydroxyapatite, amorphous calcium phosphate, and mixtures thereof . Exemplary CPCs are brushite-, monetite- or hydroxyapatite-based one, two or multicomponent cement systems; Calcium sulfate-based cements or organic-inorganic-composite cements containing a organic admixture (preferably not a thermoplast) that can be divided into natural polymers and synthetic polymers . Natural polymers mainly include gelatin, sodium alginate, silk fibroin and chitosan (see, e . g. , P . G. Ginebra . Chapter 10 in Orthopedic bone cements, Sanjukta Deb (ed) Woodhead publishing, 2008 and Liu et al, J. Funct . Biomat . 2023, 14, 134 ) .

[0098] As is known to the skilled person, a hardening material and in particular a cement is typically stored in dry form (e . g. water-free and / or solvent-free) such that it does harden, e . g. not form hardened hardening material, during storage . The kit of parts described herein preferably comprises the hardening material in a storable form, e . g. as a powder, neat, water-free and / or solvent-free . However,the hardening material in the kit of parts may also be predissolved, in particular if such a form of the hardening material is suitable for storage; or in the case of a thixotropic gel, the hardening material can be in a pasty or gelled form for storage / in the kit . The kit of parts may further and optionally separately include a suitable amount of a solvent (e . g. water) , solvents or mixtures of solvents to mix the hardening material with, in order to obtain a pasty / liquid hardening material which can then be used in orthopedic surgery, and which will harden to a structure after being administered to a given location during orthopedic surgery.

[0099] An exemplary hardening material for use in the present invention can be a calcium phosphate-based cement, e . g. in a formulation published by Y. Maazouz (Maazouz et al . Acta Biomaterialia, 49 : 563-574, 2 2017 ) . For example, the hardening material can be based on a hydrogel, e . g. a Pluronic F-127 hydrogel, as the liquid phase and an a tricalcium phosphate (TCP) powder as the powder phase, e . g. according to the following formulation :

[0100] Component Composition

[0101] Powder phase a-tricalcium phosphate (TCP) ,

[0102] optionally including 2.5 wt% phosphate monohydrate (MCPM)

[0103] Liquid phase 20 wt% Pluronic F-127 hydrogel +

[0104] 2 wt% Na2HPO4 solution

[0105]

[0106] Liquid-to-powder ratio 0.35 mL / g to 0.5 mL / g, optionally 0.35 mL / g without MCPM and 0.5 mL / g with MCPM

[0107]

[0108] Other exemplary hardening materials include, e . g. , a powder phase containing dicalcium phosphate dihydrate (DCPD) , tetra-calcium phosphate (TTCP) , and dicalcium phosphate anhydrous (DOPA) to obtain an apatitic cement with a TTCP and hydroxyapatite (HA) phase .

[0109] In an embodiment of the kit of parts according to the present invention, which may be combined with any of the embodiments of the kit of parts preaddressed or still to be addressed unless in contradiction, the kit of parts further comprises an instrument configured to administer the hardening material into a recess in a hard tissue .

[0110] The kit of parts may include an instrument with which the hardening material (in its liquid or pasty form) can be introduced into a recess in a hard tissue . Suitable instruments are known in the art and include, e . g. a cannula .

[0111] The features of the above-mentioned embodiments of the form shaping tool and the kit of parts can be used in any combination within the scope of the claims, provided they do not contradict each other .

[0112] In an aspect, which may be combined with all embodiments and aspects previously discussed and to be discussed, unless in contradiction, the present invention is directed to a method for implanting an implant having thermoplasticproperties into a hard tissue, the method comprising the following steps :

[0113] a) providing an implant having thermoplastic properties and comprising a liquifiable thermoplastic material;

[0114] bl ) creating a recess in a hard tissue with the form shaping tool as disclosed herein, the recess being suitable for inserting the implant, while or followed by creating an indentation in a sidewall of the recess, or

[0115] b2 ) providing a hard tissue with a recess suitable for inserting the implant and creating an indentation in a sidewall of the recess in the hard tissue with the form shaping tool as disclosed herein;

[0116] c) inserting the implant into the recess while or followed by transmitting ultrasound to the implant for a time sufficient to liquify at least a part of the liquifiable thermoplastic material to the extent that at least a part of the liquified thermoplastic material extends into the indentation .

[0117] In an aspect, which may be combined with all embodiments and aspects previously discussed and to be discussed, unless in contradiction, the present invention is directed to a method for implanting an implant having thermoplastic properties into a hard tissue, the method comprising the following steps, in particular in the given order :

[0118] a) providing an implant having thermoplastic properties and comprising a liquifiable thermoplastic material;bl ) creating a recess in a hard tissue suitable for inserting the implant, while or followed by creating an indentation in a sidewall of the recess, and / or

[0119] b2 ) providing a hard tissue with a recess suitable for inserting the implant and creating an indentation in a sidewall of the recess in the hard tissue;

[0120] c) inserting the implant into the recess while or followed by transmitting ultrasound to the implant for a time sufficient to liquify at least a part of the liquifiable thermoplastic material to the extent that at least a part of the liquified thermoplastic material extends into the indentation,

[0121] wherein a volume of the indentation in the sidewall of the recess is equal to or greater than a volume of the liquified thermoplastic material .

[0122] Of course, the recess in the hard tissue may also already be provided and the inventive method will then "only" comprise the step of creating an indentation in a side wall of the recess, and the subsequent steps .

[0123] The above method is also suitable for creating an indentation in a hardening material (as described herein) that was filled into a recess in a hard tissue . For easier reading and for reasons of clarity only, the recess in the hard tissue, into which the hardening material is filled or inserted, is called "opening" . Essentially, the opening can have, e . g. , the same features and properties as those described for the recess .

[0124] In an aspect, which may be combined with all embodiments and aspects previously discussed and to be discussed,unless in contradiction, the present invention is directed to a method for implanting an implant having thermoplastic properties into a hard tissue, the method comprising the following steps :

[0125] a) providing an implant having thermoplastic properties and comprising a liquifiable thermoplastic material;

[0126] bl ) providing a hard tissue with an opening or providing a hard tissue and creating an opening into the hard tissue with the form shaping tool as disclosed herein, followed by filling the opening at least partially with a hardening material; or

[0127] b2 ) providing a hard tissue with an opening at least partially filled with a hardening material;

[0128] followed by

[0129] creating a recess in the non-hardened, partially hardened or fully hardened hardening material with the form shaping tool according to any of the embodiments disclosed herein, the recess being suitable for inserting the implant, while or followed by creating an indentation in a sidewall of the recess in the hardening material with the form shaping tool as disclosed herein;

[0130] c) inserting the implant into the recess in the hardening material while or followed by transmitting ultrasound to the implant for a time sufficient to liquify at least a part of the liquifiable thermoplastic material to the extent that at least a part of the liquified thermoplastic material extends into the indentation, optionallywherein a volume of the indentation in the sidewall of the recess in the hardening material is equal to or greater than a volume of the liquified thermoplastic material .

[0131] In an aspect, which may be combined with all embodiments and aspects previously discussed and to be discussed, unless in contradiction, the present invention is directed to a method for implanting an implant having thermoplastic properties into a hard tissue, the method comprising the following steps :

[0132] a) providing an implant having thermoplastic properties and comprising a liquifiable thermoplastic material;

[0133] bl ) providing a hard tissue with an opening or providing a hard tissue and creating an opening into the hard tissue, followed by filling the opening at least partially with a hardening material; or

[0134] b2 ) providing a hard tissue with an opening at least partially filled with a hardening material;

[0135] followed by

[0136] creating a recess in the non-hardened, partially hardened or fully hardened hardening material suitable for inserting the implant, while or followed by creating an indentation in a sidewall of the recess in the hardening material; c) inserting the implant into the recess in the hardening material while or followed by transmitting ultrasound to the implant for a time sufficient to liquify at least a part of the liquifiable thermoplastic material to theextent that at least a part of the liquified thermoplastic material extends into the indentation,

[0137] wherein a volume of the indentation in the sidewall of the recess in the hardening material is equal to or greater than a volume of the liquified thermoplastic material .

[0138] In the above methods, an opening in a hard tissue, into which hard tissue an implant should be inserted, is at least partially filled with a hardening material (as disclosed herein) . The hardening material can be used to fill the opening, or it can be used to line the opening, optionally the sidewalls and / or indentations in the opening. The recess into which the implant is inserted is then created in the hardening material (if the hardening material at least partially fills the opening) . If the hardening material lines the sidewalls of the opening and / or indentations therein, the form shaping tool can be used to create indentations in the hardening material lining the sidewalls and / or ( further) shape indentations in the opening that are lined with the hardening material .

[0139] All examples and definitions provided in the context of the kit of parts also apply to the methods described herein, unless specifically stated otherwise .

[0140] For example, in an embodiment of the methods, implanting is performed for fixating the implant in the hard tissue .

[0141] The hardening material for use in the context of the present methods can be the hardening material as defined herein. The recess can be created in the context of the present methods by the form shaping tool as defined herein.The hard tissue may be an artificial or a natural hard tissue, a hard tissue sample outside of the human body, a hard tissue of a dead body or a hard tissue of a patient . For example, the implant having thermoplastic properties and comprising a liquifiable thermoplastic material of step a) is an implant as previously described for the kit of parts, in particular an implant being part of the kit of parts . In an embodiment of the methods, step a) is performed before or simultaneously to step bl ) or step b2 ) . For example, the recess or opening in step bl ) may be created by modifying an already existing recess or opening in the hard tissue . Such an already existing recess or opening may be for example provided by a drilling or punching tool (e . g. operated by a surgeon) . In this case, creating the indentation is performed after creating the recess . Alternatively, creating the indentation may be performed simultaneously to creating, optionally drilling the recess .

[0142] Additionally, or alternatively to step bl ) , the methods comprise step b2 ) in which the indentation is created into a sidewall of an already existing recess . Such an already existing recess may for example be formed in a natural way, for example due to an accident, disease or injury. For example, the recess according to the invention may have a depth in the range of 4 mm to 30 mm, in particular 4 mm to 10 mm and / or a diameter in the range of 0.7 mm to 6 mm, in particular 1.0 mm to 5.0 mm.

[0143] For example, the indentation (and optionally the recess) can be created into a completely hardened or partiallyhardened hardening material . For example, the indentation (and optionally the recess) can be created into a nonhardened hardening material, e . g. by inserting the form shaping tool and removing the same when the hardening material has become sufficiently hardened such that the indentation of the form shaping tool remains in the (partially or fully hardened) hardening material .

[0144] The hardening material may be one as already described in the context of the kit of parts and be applied inside the recess in order to, for example, strengthen the bone structure .

[0145] In an embodiment of the methods, the application of the hardening material into the opening may be performed immediately before creating the indentation. For example, the hardening material may be applied such that i) it covers only the sidewall, and optionally the bottom, of the opening leaving at least some volume of the opening empty, or ii) the total volume of the opening can be filled with the hardening material . In the latter alternative ii) , the opening can first be recreated by at least partially removing the hardening material at the location of the opening. This can be performed, for example, by using a drill, or a form shaping tool according to any of the embodiments disclosed herein. Preferably, the recess and the indentation can be created simultaneously by one and the same tool, for example the form shaping tool according to any embodiment disclosed herein and comprising or having a drill functionality and / or a cutting edge at the distal end of the body for creating the recess and at least oneprotrusion arranged on the body for creating the indentation .

[0146] For example, in the first alternative i) , where at least a part of the opening' s volume is not filled with the hardening material, the indentation in the hardening material may be created directly by using the form shaping tool . In step c) , the implant of step a) is inserted into the recess of step bl ) or step b2 ) while or before ultrasound is transmitted to it . In any case, transmission is such that the implant having thermoplastic properties is at least partially liquified by the ultrasound transmitted, for example by a sonotrode, e . g. to the extent that fixation of the implant in a recess of an obj ect is achieved after solidification of the implant . The

[0147] liquif ication results in the flow of the liquified part of the implant into the indentation in the sidewall of the recess, which results in fixation of the implant in the recess, stabilization of the indentation and stress reduction in the indentation structure .

[0148] In any case, at least a part of the liquified thermoplastic material must extend into the indentation. For the sake of clarity, it should be noted that the indentation is to be understood as a macroscopic indentation, which can be achieved, for example, by using an awl, a reamer or any other suitable tool (e . g. the form shaping tool disclosed herein) for providing a macroscopic indentation in the sidewall of the recess . Pores being an intrinsic property of the hard tissue, for example bone pores, are not meant as an indentation in the context of the present invention.In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the non-hardened, fully hardened or partially hardened hardening material covers a sidewall of the opening and optionally an indentation in the sidewall of the opening, and an indentation in the hardening material and / or in the opening in the hard tissue is created.

[0149] In an embodiment in which the ultrasound transmission is achieved by a sonotrode, the implant for example comprises an implant cavity, recess, opening or elongated cavity, recess, opening or hole (e . g. an axially extended opening) extending from a surface of the implant into a body of the implant, which cavity can interact with the sonotrode so that the implant can be received by a tip of the sonotrode . According to the methods, the volume of the indentation in the sidewall of the recess can be equal to or greater than a volume of the liquified thermoplastic material, optionally under the standard conditions of 25°C and 1 bar pressure . In an embodiment of the methods, the volume of the indentation in the sidewall of the recess is equal to or greater than the volume of the liquified thermoplastic material that extends into the indentation such that at least some of the liquified thermoplastic material does not fill the indentation. This embodiment allows for a form fit between the thermoplastic and the hard tissue both inside and outside the indentation, within the recess .

[0150] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the volume of the liquified thermoplasticmaterial minus a volume of the recess excluding a volume of the indentation is equal to or smaller than a volume of the indentation, optionally under the standard conditions of 25°C and 1 bar pressure .

[0151] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the volume of the indentation in the sidewall of the recess is equal to or greater than a volume of the liquifiable thermoplastic material of the implant .

[0152] As, in this embodiment, the volume of the indentation is equal or greater than the volume of the liquifiable volume of the thermoplastic material, either the entire volume or not the entire volume of the indentation can be filled upon liquifying the thermoplastic material . In any case, according to this embodiment, if the entire liquified material will enter inside the indentation, there will be no excess material volume that goes beyond the indentation and, for example, adheres with a sidewall of the core volume of the recess .

[0153] An embodiment in which the entire liquified volume of the thermoplastic material is positioned within the indentation is particularly advantageous, e . g. , for stabilizing the indentation walls and offers a convenient compromise between the amount of thermoplastic material to be used within the implant, time of liquifying the thermoplastic during surgery, and convincing fixation strength of the implant .

[0154] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, wherein the indentation has a depth to widthratio selected from the list of : less than 2, in the range of 1 to 2 and less than 1.

[0155] optionally wherein every single indentation being part of the total indentation has a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 and less than 1 , in particular in a proximal section of the recess . The proximal section of the recess is the section that is cortical or subcortical, e . g. the proximal half of the recess . For example, the depth to width ratio noted above apply in particular to the indentation ( s ) created by the second section of the form shaping tool, which is a protrusion configured to shape, optionally round off, the indentation .

[0156] The depth to width ratio is measured in the side profile of the recess, i . e . in a cross section along an intended insertion direction of the implant, for example a direction along which the recess was drilled or in a cross section parallel to a depth extension of the recess . In particular, the measurement of the depth is performed at the part of the indentation being most remote from the core volume of the recess, i . e . the recess volume excluding the indentation, and the measurement of the width is performed at the part of the indentation being most broad.

[0157] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the indentation has a parabolic, sinusoidal, or trapezoidal profile; and / or the indentation has a rounded crest, in particular a crest rounded by a circular arc, optionally a circular arc of 2 x ( 9O°-0) , wherein 0 is theflank angle of the indentation, in particular in a proximal section of the recess . The proximal section of the recess is the section that is cortical or subcortical, e . g. the proximal half of the recess .

[0158] In particular, profiles having smooth or rounded edges, i . e . not comprising any sharply angled edges, have been found advantageous, as rounded volumes have, e . g. , an increased volume to surface ratio allowing for an uptake of more thermoplastic material at a smaller indentation surface .

[0159] For example, the indentation profile is made out in a cross section parallel to a depth extension of the recess . For example, the profile and / or rounded crest noted above apply in particular to the indentation ( s ) created by the second section of the form shaping tool, which is a protrusion configured to shape, optionally round off, the indentation.

[0160] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, at least one of the following applies :

[0161] the hard tissue is a bone,

[0162] the hard tissue is a cortical bone and / or a spongy bone,

[0163] the method steps are performed in the given order, or a combination thereof .

[0164] The cortical bone, as understood herein, is a compact bone with a high density and strength and forming the outer layer of a bone . The spongy bone, also known as cancellous or trabecular bone, is a lighter, less dense type of bonetissue found within the interior of bones . The spongy bone is characterized by a porosity of 50% to 90% and apparent density of 0.5 g / cm3to 1.0 g / cm3.

[0165] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, at least one of the following applies :

[0166] the recesses or opening is created in a bone and is created to reach through the cortex of the bone into the spongy bone;

[0167] the recess has a constant diameter or is tapered in direction from a proximal end to a distal end of the recess ;

[0168] the indentation in the sidewall of the recess is created in a section of the recess in the cortex of the bone only, or

[0169] a combination thereof .

[0170] In an embodiment, the recess created in the methods, in particular in step bl ) and / or step b2 ) , is a recess having a bottom, i . e . wherein the recess does not reach through the entire bone to have at least two openings, but has only one opening instead. Alternatively, or in combination, the recess has two or more openings, for example reaching through the entire hard tissue or bone thickness .

[0171] An embodiment, in which the indentation is created in the sidewall of the recess in a section of the recess in the cortex of the bone only, allows for fixing the implant in a more stable way, the cortex (also called the cortical bone) being less susceptible to damage than the spongy bone structure . In particular, the cortical bone has about 10-20times the strength if compared to the spongy bone . It is also compact instead of porous and can therefore absorb and transmit forces more homogeneously than the spongy bone . In this way, a convenient fixation within the cortical bone can be reached.

[0172] Tapered from a proximal end of the recess (i . e . in the proximity of the opening of the recess) to a distal end of the recess (for example at a bottom of the recess) , as used herein, means that the diameter of the recess decreases from the proximal end to the distal end, e . g. linearly or stepwise . Tapered, as used herein, also includes that only a section of the recess is tapered, while other section (s) have a constant diameter . In an example, the tapered section of the recess is closer to the proximal than to the distal end.

[0173] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the indentation in the sidewall of the recess is created with the form shaping tool as defined in any one of the previously mentioned embodiments, and the implant is as defined in any one of the previously mentioned embodiments, in particular wherein a volume of the recess excluding the indentation volume corresponds to the body volume and optionally the indentation volume corresponds to the protrusion volume .

[0174] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the form shaping tool and the implant are provided as the kit of parts according to any one of the previously mentioned embodiments .In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the indentation is a thread, optionally a thread created by a form shaping tool as defined in any of the previously mentioned embodiments . The indentation being a thread means, e . g. , that the indentation has the form of a thread, the thread extending into the hard tissue .

[0175] For example, the indentation may be a single or a multiple thread and optionally be created by the shape forming tool according to any of the preceding kit of parts or method embodiments, unless in contradiction.

[0176] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the recess has a distal end in the hard tissue, in particular in a spongy bone, or reaches through the hard tissue .

[0177] As already mentioned, the recess can comprise only one opening arranged in a proximal end of the recess, for example in a bone surface, or it can comprise more than one opening and reach through the bone . In an embodiment wherein the recess has a distal end in the hard tissue, in particular in a spongy bone, the recess preferably has one opening only. However, also an embodiment with more than one opening and a distal end in the hard tissue is possible and practicable, for example with a recess having a U-, V- , C- , W-, or L-shape and the distal end being arranged between and below the at least two openings of the recess . In an embodiment of the method which can be combined with any of the embodiments already mentioned or to be mentioned, the indentation is created such that a volume ofthe indentation decreases from a proximal end of the recess to a distal end of the recess .

[0178] There will be embodiments in which the indentation volume is composed of both a threaded indentation and another indentation form, summing up to the indentation volume . In an embodiment, the indentation volume or, in a more specific embodiment, the threaded indentation volume, decreases from the proximal to the distal end of the recess, e . g. from the top opening of the recess to a bottom of the recess .

[0179] In an embodiment where the recess comprises more than one opening and optionally reaches through the bone, the indentation can be created such that the volume of the indentation decreases from one to another opening.

[0180] Without wishing to be bound by theory, such a geometrical form of the indentation offers the advantage that any liquified thermoplastic material of the implant can be more conveniently distributed within the recess and hence result in a better implant fixation. In an embodiment, in which the recess including the indentation has a shape tapered towards the distal end, the liquified thermoplastic material flows faster towards the distal end of the recess, for example to the bottom, and enters into a significant volume of the indentation, in particular more than one indentation sub-volume if the overall indentation is composed of more than one indentation sub-volume . This in turn increases the surface area on which the force and / or stress transfer between the thermoplastic material and the hard tissue may occur . The decreasing indentation volume also allows for a faster flow of the liquifiedthermoplastic material and for example reduces the surgery time and enhances the surgeon' s or optionally patient ' s comfort .

[0181] A recess geometry in which the volume of the indentation, in particular a threaded indentation, decreases from the proximal to the distal end of the recess allows a larger amount of polymer to be introduced into an indentation at the proximal end of the recess than at the distal end.

[0182] In an embodiment in which the recess entirely has a conical shape or a section having a conical shape, the flow of the liquefied thermoplastic material may be optimized by the form shaping . For example, more of the liquefied material may flow in the direction to the distal end of the recess by undermeasuring the conic shape resp . the conic angle of the recess or a section of the recess . For example, the conic angle of a recess entirely having a conical shape or a section having a conical shape may be from 1 ° to 50° , optionally from 5° to 45° , 10° to 40° , 15° to 35° , 20° to 30° , or 25° . In an embodiment of the methods, wherein the recess comprises an indentation being a thread, the entire amount of the liquefied thermoplastic material preferably is not limited to one turn of the thread, optionally being introduced into 2 or 3 thread turns .

[0183] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the volume of the indentation decreases by a factor of 3, optionally 2, from a proximal end to a distal end of the recess, optionally over a recess that has a depth of 10 mm, optionally of 5 mm.In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, an opening of the recess has a diameter greater than any other diameter of the recess, optionally excluding the indentation.

[0184] A recess which has the biggest diameter at its opening is advantageous for an easy insertion of the implant . In an embodiment, the opening is circular and has a diameter greater than any other diameter of the recess excluding the diameter including the indentation. With a larger opening area of the recess, an insertion of the implant is easier and / or faster .

[0185] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the recess has a tapered section, in particular a tapered shape, in the direction from a proximal end to a distal end of the recess .

[0186] As already mentioned, a recess comprising at least a tapered section or entirely itself having a tapered shape, is advantageous for that, e . g. , any liquified thermoplastic material of the implant can be more conveniently distributed within the recess . For the sake of clarity, it should be noted that the tapered shape is to be understood verbatim or roughly describing the form of the recess .

[0187] In an embodiment, any small deviations from a tapered shape, such as for example grooves left behind by a form shaping tool or any small abrasions should be neglected. In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, a volume of the recess excluding the indentationvolume is constant or decreases from an opening to a bottom of the recess by a factor smaller than a factor by which a volume of the recess including the indentation volume decreases from the opening to the bottom of the recess . A geometric design, in which the volume of the indentation decreases by a factor bigger than the volume of the recess core (i . e . the recess excluding the indentation) allows a large area of the recess walls to be covered with liquified thermoplastic material, with a significant amount of the material being introduced into and adhered to the indentation. In particular, as the ratio of the indentation volume to the recess core volume decreases in the direction from the opening of the recess, the proportion of the core volume is biggest at the bottom of the recess . This in turn results in an effective accumulation of the liquified material at the bottom of the recess, in particular of the material that has not entered or adhered to the sidewall of the indentation. This creates optimal conditions for a convenient or even excellent fixation of the implant inside the recess .

[0188] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the ultrasound in step c) is transmitted by a sonotrode as defined in or being part of the kit of parts according to any one of the embodiments already mentioned. In an embodiment of the kit of parts or the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the hard tissue is a human, animal or artificial hard tissue, optionally a cartilage-covered hard tissue, and optionally wherein the hard tissueis a hard tissue sample outside of the human or animal body, a hard tissue of a dead body or a hard tissue of a human or animal patient or an artificial bone graft material .

[0189] For example, an artificial hard tissue may be any hard tissue produced by using any biofabrication technique, such as incorporating cells into a biodegradable scaffold, or optionally a hard tissue made of a synthetic polymer .

[0190] In an embodiment of the kit of parts or the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the hard tissue, in particular the spongy portion of the hard tissue, has a reduced bone density, optionally is an osteoporotic bone, which for example may be sensitive to notch stress . Herein, smooth and low-notch-stress recess geometries are particularly advantageous .

[0191] For example, the reduced bone density may be determined by DXA testing (densitometer testing) , an osteoporotic bone having a mineral density of equal or less than -2.5.

[0192] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the methods are for treatment of a shoulder or cruciate ligament injury.

[0193] In an embodiment of the methods which can be combined with any of the embodiments already mentioned or to be mentioned, the hardening material is as defined herein and / or the recess is created by the form shaping tool as defined herein.The features of the above-mentioned embodiments of the method can be used in any combination within the scope of the claims, provided they do not contradict each other . The definitions and explanations given for the terms and features of the present invention apply to all aspects and embodiments disclosed herein, unless specifically indicated otherwise .

[0194] BRIEF DESCRIPTION OF THE FIGURES

[0195] Embodiments of the current invention are described in more detail in the following with reference to the figures .

[0196] These are for illustrative purposes only and are not to be construed as limiting. It shows

[0197] Fig. 1 A-F schematic depictions of different kit of parts embodiments;

[0198] Fig. 2 a schematic depiction of the form shaping tool connected to a mechanic tool for providing a recess; Fig. 3 A-C schematic depictions of different form shaping tool embodiments;

[0199] Fig. 4 A-C schematic depictions of different form shaping tool embodiments;

[0200] Fig. 5 a schematic depiction of the method for implanting the implant into a hard tissue (step a) to step c) ) ;

[0201] Fig. 6 A-C schematic depictions of different recess embodiments ;Fig. 7 A-E further schematic depictions of different recess embodiments;

[0202] Fig. 8 depiction of a form shaping tool comprising a notch and two cutting edges at the distal end of the tool ;

[0203] Fig. 9 A-F depictions of different form shaping tool embodiments ;

[0204] Fig. 10 A-D exemplary method disclosed herein;

[0205] Fig. 11 A-B schematic depictions of the thread profiles in cross-sectional view;

[0206] Fig. 12 A-C depictions of different form shaping tool embodiments; and

[0207] Fig. 13 schematic depiction of a form shaping tool comprising a first and a second section.

[0208] DETAILED DESCRIPTION OF THE FIGURES

[0209] Figure 1 shows six different embodiments of the kit of parts A-F. The kit of parts comprises an implant 1 (left) having thermoplastic properties and a form shaping tool (right) . The form shaping tool shown in Fig. 1A is shown in a cross section through the form shaping tool, along the direction of its length extension, e . g. the direction for insertion or drilling. The form shaping tool comprises only one protrusion 2 arranged on the body 3 of the form shaping tool .

[0210] The form shaping tool shown in Fig. IB differs from the one of Fig. 1A by comprising a further protrusion 2 arranged onthe same side of the body 3. The person skilled in the art will understand that the volume of the protrusion 2 is composed of the sub-volumes (e . g . the sum of the volumes which in the cross section look like the triangles) .

[0211] The form shaping tool shown in Fig. 1C differs from the one of Fig. IB by the arrangement of the further protrusion 2, here arranged on a different side, in particular the opposite side, of the body 3.

[0212] The embodiments depicted in Fig. ID to IF show different embodiments of the implant 1. Differently from the previously shown embodiments, the implant 1 comprises an opening arranged at the bottom, for example for guiding through a suture (cf . Fig. IF) . The surface of the implant 1 can be smooth and plane, as depicted in Fig. 1A to 1C, or it can be non-planar and comprise, for example, elevations or sections made of different materials (cf . Fig. ID to IF) .

[0213] The form shaping tool shown in Fig. ID to IF has a protrusion 2 in the form of a thread arranged at the body 3 of the form shaping tool . The body 3 of the form shaping tool narrows towards the distal end.

[0214] Figure 2 shows the form shaping tool of Fig. ID to IF connected to a mechanic tool for providing a recess, e . g. a driller . The form shaping tool is connected to the mechanic tool via its proximal end. Of course, the mechanic tool is only an optional part of the kit of parts and any drilling operation can also be performed manually.

[0215] Figure 3 shows the embodiments of the form shaping tool previously shown in Fig. 1A, 1C and ID to IF. The formshaping tools of Fig. 3A to 3C are shown in a cross section through the form shaping tool, along the direction of its length extension, e . g. the direction for insertion or drilling. Herein the relation between the body 3 and the at least one protrusion 2 is clearly shown by imaginary dividing these elements with the help of the dashed lines .

[0216] Figure 4 shows the embodiments of the form shaping tool similar to those previously shown in Fig. 3A to 3C .

[0217] Depicted are form shaping tools comprising a tool section 4 that has a diameter larger than a diameter of the body 3 including the at least one protrusion 2, which tool section 4 is arranged at the proximal end of the body 3. Herein the cone angle a of the tool section 4 of the form shaping tool is clearly shown with the help of the dashed lines . While the tool section 4 of Fig. 4A and 4B is arranged at the body 3 as a two-piece design, in Fig. 4C it is an integral part of the body 3 and made, for example, of the same material as the rest of the body 3.

[0218] Figure 5 shows a schematic depiction of the method for implanting the implant 1 into a hard tissue 5 (step a) to step c) . Depicted is also the direction of providing the recess 6, symbolized by the axis y. In step a) an exemplary implant 1 having thermoplastic properties and comprising a liquifiable thermoplastic material is provided. In step b) a hard tissue 5 with a recess 6 suitable for inserting the implant 1 is provided, the recess 6 comprising a schematic indentation 7 in a sidewall of the recess 6 in the hard tissue 5. In the subsequent step c) (depicted as cl ) , the implant 1 is inserted into the recess 6 while or followedby transmitting ultrasound to the implant 1 for a time sufficient to liquify at least a part of the liquifiable thermoplastic material . As can be seen in Fig. 5 (c2 ) , at least a part of the liquified thermoplastic material 8 extends into the indentation 7, wherein a volume of the indentation 7 in the sidewall of the recess 6 is greater than a volume of the liquified thermoplastic material 8. Figure 6 shows different schematic forms of the recess 6 in a cross section parallel to the direction of providing the recess 6 and optionally inserting the implant 1. Figures 6A to 6C show embodiments having different depth to width ratios of the indentation 7. In Fig. 6A the ratio is less than 2, about 1.5 or exactly 1.5. In Fig. 6B the ratio is about 1 or exactly 1. In Fig. 6C the ratio is less than 1, about 0.5 or exactly 0.5. Please note that the recess 6 is imaginary divided by vertical dashed lines along the sidewalls of the recess 6. This division is done by the way of example to clarify where the indentation 7 volume (vertically dashed surface) starts . The horizontally dashed surface corresponds to the core volume of the recess 6, the core volume and the indentation 7 volume summing up to the recess ' 6 volume .

[0219] Figure 7 shows different schematic forms of the recess 6 in a cross section parallel to the direction of providing the recess 6 and optionally inserting the implant 1. Similarly to Fig. 6A, the imaginary division between the indentation 7 (volume) and the core (volume) is shown in Fig. 7A, 7D and 7E . The depicted embodiments have a roundly shaped indentation 7 contour which for example can be provided bya form shaping tool with a protrusion 2 in the form of a thread. In Fig. 7A, the sub-indentations look the same in the cross section, i . e . they have the same indentation 7 sub-volume . In Fig. 7B a further indentation type is shown. Such indentation 7 can be for example provided by a form shaping tool comprising both a thread and a rod protrusion 2. In the embodiment of Fig. 7C the sub-volumes of the subindentations decrease in the direction from the proximal end to the distal end of the recess 6.

[0220] The recess 6 forms of Fig. 7D and 7E are particularly different . The recess 6 of Fig. 7D is an "open" recess, i . e . it comprises more than one opening and forms a tunnel through the hard tissue 5, in particular through a bone . The recess 6 of Fig. 7E has a core volume, i . e . volume of the recess 6 excluding the indentation 7 volume, which decreases from the proximal to the distal end of the recess 6. In the depicted embodiment, the bottom of the recess 6 has a V-shape . In the depicted embodiment, both the indentation 7 volume and the core volume decrease in said direction .

[0221] Figure 8 shows a section of a form shaping tool comprising a notch 10 and two cutting edges 9 partially extending from the distal end of the for shaping tool to the proximal end. The notch can follow the tool ' s axis, and, as shown, may have a helical path along the axis . The notch 9 extends both inside the protrusion 2 (here in the form of a thread) and inside the body 3. In the depicted embodiment, the notch 10 is provided in the distal part of the tool, i . e . in the lowest 25% of the tool ' s length. However, in anembodiment of the form shaping tool, the notch 10 can also be provided only in the lowest 10% or 50% of the tool ' s length or even extend up to the proximal part of the tool, i . e . above 50% of the tool ' s length in direction to the proximal end of the body 3.

[0222] Figure 9 shows six different embodiments of the form shaping tool, wherein the protrusion 2 has the form of a thread arranged on the body 3. The embodiments of

[0223] Fig. 9A / 9B, 9C / 9D and 9E / 9F have threads of a similar design, in particular of the same thread pitch. They differ in pairs based on the rounding of the thread edges, for example, the tools of Figs . 9A, 9C and 9E have a V-shaped thread form and the tools of Figs . 9B, 9D and 9F have a thread with a rounded crest . The width 16 and depth 17 of the thread, as used herein, are exemplified in Figure 9A. Figures 10A-10D show steps of a method of the present invention, wherein a hardening material 11 for orthopedic use is used. Fig. 10A shows a hard tissue 5 with an opening 12 that was preformed or created in the context of the present method. A hardening material 11 is then provided and at least partially filled into the opening 12, as shown in Fig. 10B. While the hardening material is preferably partially hardened, a form shaping device as defined herein (and only schematically depicted next to the arrow) is provided and used to create an indentation in the hardening material as shown in Fig. 10C. Alternatively, the form shaping tool may be inserted into the non-hardened hardening material and, e . g. removed when the hardening material has sufficiently hardened such that the formedindentation remains upon removal of the tool . When the hardening material is preferably partially hardened, an implant 1 having thermoplastic properties as defined herein is provided, and inserted into the recess 6, as shown in Fig. 10D, while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant 1 to the extent that a liquified at least partial volume 8 of the implant extends into the (e . g. at least partially hardened) hardening material . If the implant is inserted while the hardening material is not form-stable, e . g. non-hardened, the liquified implant may also displace a volume of the hardening material before resolidifying. The steps described in the context of Figs . 10A-10D can be carried out such that the indentation is created and / or the implant is inserted when the hardening material is ( fully) hardened, which, e . g. , is accompanied by creating a recess in the hardened hardening material before creating the indentation . The recess can for example be done by a drill or a punching tool, or by a form shaping tool additionally comprising or having a drilling or punching element / function or a cutting edge, in particular at the distal end of the body. For example, a form shaping tool as depicted in Fig. 8 could be used for this purpose .

[0224] Figures 11A and 11B show two thread profiles of a form shaping tool in a cross-sectional view. Depicted is only one side of the profile; for example the thread can be a symmetrical thread - i . e . the "other" , non-depicted side may be identical to the depicted one . Fig. 11A shows a section of a V-type thread profile with sharp edged crests13 suitable for cutting the hard tissue and / or creating a recess in a hard tissue (and / or cutting into the hardening material) . Fig. 11B shows a section of a thread profile with two rounded crests 13. The crest 13 is rounded by a circular arc having an arc length of 2 x ( 90°-©) , wherein 0 is the flank angle of the indentation. The radius r corresponds to the radius of the circular arc ' s circle . Exemplary flank angles 0 include 20° to 35° , optionally about 30° . Exemplary radius values include, e . g. , 0.2 mm to 2 . 0 mm.

[0225] Figures 12 A-C show three embodiments of the form shaping tool, in which the protrusion 2 is a thread comprising both a sharp and a rounded crest . The sharp crest can correspond to the first section of the protrusion and is arranged closer to the distal end of the form shaping' s tool body 3 (closer than the second section) . The first section gradually transitions into a second section of the protrusion having a rounded crest and extending in the direction of the proximal end. The sharp crest is suitable for cutting the hard tissue while the rounded crest is suitable for reaming the recess . In the depicted examples, the thread depth of both the sharp and the rounded crests is essentially the same . However, in other not shown embodiments also falling within the scope of the invention, the thread depth measured at the sharp and the rounded crests may be different from each other . In an embodiment, the thread depth measured at the sharp crest (the first section of the protrusion) is smaller than the thread depth measured at the rounded crest (second section of theprotrusion) and / or the thread depth measured at the sharp crest at the distal end of the body is the smallest .

[0226] In an embodiment not depicted herein, which however may be combined with other embodiments disclosed herein unless in contradiction, the thread depth measured at the sharp crest arranged at the distal end of the body and / or the rounding of the crest gradually or stepwise increase in the direction to the proximal end.

[0227] Figure 13 shows a schematical depiction of a form shaping tool comprising a first section 14 arranged closer to the distal end of the body than a second section 15 (e . g. arranged closer to the proximal end of the body) . The depicted tool comprises an optional drilling tip adj acent to the first section 14 at the distal end. Between the first and the second section there may be at least a third section different from the first and / or the second section. Alternatively, the first and the second sections may be provided adj acent to each other .

[0228] It can be seen that the crests of the first section 14 are sharper than the crests of the second section. In the depicted example, the thread depth of the threads in the first and the second section is essentially the same .

[0229] However, in other not shown embodiments also falling within the scope of the invention, the thread depth measured at the sharp and the rounded crests in the first and the second section 14 and 15 may be different from each other . In an embodiment, the thread depth measured at a sharp crest in the first section 14 is smaller than the thread depth measured at a rounded crest in the second section 15.REFERENCE SIGNS LIST

[0230] 1 Implant 13 Crest

[0231] 2 Protrusion 14 First section 3 Body 15 Second section 4 Tool section r Radius

[0232] 5 Hard tissue 16 Width

[0233] 6 Recess 17 Depth

[0234] 7 Indentation

[0235] 8 Liquefied

[0236] thermoplastic

[0237] material

[0238] 9 Cutting edge

[0239] 10 Notch

[0240] 11 Hardening material

[0241] 12 Opening

Claims

67CLAIMS1. A surgical form shaping tool having a body (3) with a proximal end, a distal end and a body (3) volume, wherein the form shaping tool further comprises at least one protrusion (2 ) on the body (3) for creating an indentation (7 ) in a sidewall of a recess ( 6) in a hard tissue (5) , wherein the protrusion has a first section ( 13) and an optionally adj acent second section ( 14 ) , wherein the first section ( 13) is closer to the distal end of the body than the second section ( 14 ) , wherein the first section ( 13) is a thread configured carve into the sidewall of the recess to form a first indentation, and the second section ( 14 ) is a protrusion configured to shape, optionally round off, the first indentation.

2. The surgical form shaping tool according to claim 1, wherein:the second section is a thread; and / orthe first ( 13) and second ( 14 ) sections are sections of a continuous thread, optionally wherein the first section has a thinner crest ( 12 ) than the second section and / or is V- shaped, and the second section has a wider crest ( 12 ) than the first section and / or is rounded by a circular arc .

3. A kit of parts comprising an implant (1 ) having thermoplastic properties comprising a liquifiable thermoplastic material, and the form shaping tool according to claims 1 or 2, or a form shaping tool, wherein the form shaping tool has a body (3) with a proximal end, a distal end and a body (3) volume, wherein the form shaping tool further comprises at least one protrusion (2 ) on the body (3) for creating an indentation68(7 ) in a sidewall of a recess ( 6) in a hard tissue (5) , wherein the at least one protrusion (2 ) has a protrusion (2 ) volume that is equal to or greater than a volume of the liquifiable thermoplastic material .The kit of parts according to claim 3, wherein a volume of the liquifiable thermoplastic material minus the body (3) volume is equal to or smaller than the protrusion (2 ) volume .

5. The form shaping tool or kit of parts according to any of claims 1 to 4 , wherein at least one of the following applies : - the form shaping tool is configured to form the recess ( 6) , - the form shaping tool is a reamer,- the hard tissue (5) is a bone,- the proximal end of the body (3) is suitable for attaching a processing tool, in particular a drilling machine,- the distal end of the body (3) is suitable for forming and / or reaming the recess ( 6) , and / or- a combination thereof .

6. The kit of parts according to any one of claims 3 to 5, wherein the at least one protrusion (2 ) is a thread.

7. The form shaping tool according to any of claims 2 to 5 wherein the thread has a volume which is constant or decreases from the proximal end to the distal end of the body (3) , or the kit of parts according to claim 6, wherein the thread has a volume which is constant or decreases from the proximal end to the distal end of the body (3) .

698. The form shaping tool or kit of parts according to any of claims 1 to 7 , wherein the thread is a multiple tread, in particular a n-start thread, further in particular wherein n = 2 , 3 , or 4 .

9. The form shaping tool or kit of parts according to any one of claims 1 to 8, wherein the thread is a clockwise or counterclockwise round thread, optionally having a thread angle of about 60° .

10. The form shaping tool or kit of parts according to any one of claims 2 to 9, wherein the thread is configured to create an indentation (7 ) having a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 or less than 1 .11 . The form shaping tool or kit of parts according to any one of claims 2 to 10, wherein :the thread has at least one flank having a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 or less than 1, optionally wherein all flanks of the thread have a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 and less than 1 ; and / or the thread has a depth to width ratio that decreases stepwise or gradually from the distal end to the proximal end of the body (3) , in particular decreases from above 2 to less than 2, in particular within 2 to 3 revolutions of the thread around the body (3) .

12. The kit of parts according to any one of claims 6 to 11 ,wherein70the thread has a first section (13) and an optionally adj acent second section (14 ) , wherein the first section (13) is closer to the distal end of the body than the second section (14 ) , wherein the first section (13) has a thinner crest (12 ) than the second section (14 ) and / or is V-shaped, and the second section (14 ) has a wider crest (12 ) than the first section (13) and / or is rounded by a circular arc .13 . The form shaping tool according to any of claims 1 to 12, wherein the thread is a symmetrical or an asymmetrical thread, optionally wherein the first section is a trapezoidal, a V-shaped, a unified, a buttress, a square, or a sinusoidal thread; and / or the second section is a trapezoidal, a unified, a buttress, a square, a Whitworth, a knuckle, a parabolic, or a sinusoidal thread, and / or at least a part of the thread of the second section has a rounded crest ( 12 ) , in particular a thread crest ( 12 ) rounded by a circular arc, optionally a circular arc of 2 x ( 90°-©) , wherein 0 is the flank angle of the thread; orthe kit of parts according to any one of claims 6 to 12, wherein the thread is a symmetrical or an asymmetrical thread, optionally a trapezoidal, a V-shaped, a unified, a buttress, a square, a Whitworth, a knuckle, a parabolic, or a sinusoidal thread,optionally at least a part of the thread has a V-shaped thread form and / or at least a part of the thread has a rounded crest (12 ) , in particular a thread crest (12 ) rounded by a circular arc, optionally a circular arc of 2 x ( 90°-©) , wherein 0 is the flank angle of the thread.14 . The form shaping tool or kit of parts according to any one of claims 1 to 13, wherein the body (3) of the form shaping tool71has a section with an inner diameter excluding the at least one protrusion (2 ) in the range of 0.8 mm to 5.0 mm or 1. 0 mm to 3.0 mm, or wherein the entire form shaping tool has an inner diameter excluding the at least one protrusion (2 ) in the range of 0.8 mm to 5.0 mm or 1. 0 mm to 3.0 mm.

15. The form shaping tool or kit of parts according to any one of claims 8 to 14 , wherein the multiple thread comprises or is a n-start thread, the n-start thread having a thread pitch configured to create at least n indentations (7 ) over a recess ( 6) length of 0.5 mm to 10.0 mm, 0.5 mm to 8.0 mm or 1.0 mm to 5.0 mm, optionally over an angle of 360° / n.

16. The form shaping tool or kit of parts according to any one of claims 1 to 15 wherein the thread has a tread pitch in the range of 0.5 mm to 3.0 mm, in particular 0. 6 mm to 2.0 mm or 0.7 mm to 1.5 mm; and / orwherein the body (3) has a section with an outer diameter including the at least one protrusion (2 ) in the range of 1. 1 mm to 3.5 mm or 1.3 mm to 3.3 mm, or wherein the entire form shaping tool has an outer diameter including the at least one protrusion (2 ) in the range of 1.1 mm to 3.5 mm or 1.3 mm to 3.3 mm; and / orwherein the form shaping tool is made of steel, stainless steel, a metal or alloy, titanium, diamond, boron carbide, a plastic material, or a combination thereof .17 . The form shaping tool or kit of parts according to any one of claims 1 to 16, wherein an outer diameter of the body (3) including the at least one protrusion (2 ) is constant from the proximal to the distal end of the body (3) or is largest72at the proximal end of the body (3) , optionally wherein an outer diameter of the body (3) including the at least one protrusion (2 ) is constant or is tapered from the proximal end to the distal end of the body (3) .18 . The form shaping tool or kit of parts according to claim 17 , wherein the at least one protrusion (2 ) comprises or is a n- start thread, wherein the outer diameter of the body (3) is constant or decreases along n thread circumferences, optionally wherein n = 2, 3, or 4 .

19. The form shaping tool or kit of parts according to any one of claims 1 to 18 , wherein an outer diameter of the body (3) including the at least one protrusion (2 ) is constant from the proximal to the distal end of the body (3) or increases from the distal end to the proximal end of the body (3) by a factor bigger than a factor by which an inner diameter of the body (3) excluding the at least one protrusion (2 ) increases from the distal end to the proximal end of the body (3) .

20. The form shaping tool or kit of parts according to any one of claims 1 to 19, wherein the form shaping tool further comprises a tool section (4 ) having a diameter larger than a diameter of the body (3) including the at least one protrusion (2 ) , the tool section (4 ) being arranged at the proximal end of the body (3) and configured to widen the recess ( 6) , in particular a proximal end of the recess ( 6) .21 . The form shaping tool or kit of parts according to claim 20, wherein at least one of the following applies :- a cone angle of the tool section (4 ) is in the range of 30° to 40° , in particular 34 ° to 35° , further in particular 34.71 ° ,- the tool section (4 ) has a length in direction from the proximal end to the distal end of the body (3) in the range of 0.1 mm to 8.0 mm, in particular 1.0 mm to 5.0 mm, further in particular 1.4 mm to 3.0 mm, or- a combination thereof .22 . The form shaping tool or kit of parts according to any one of claims 1 to 21 further comprising a tool for creating the recess ( 6) in the hard tissue (5) , optionally attached to the distal end of the form shaping tool .

23. The form shaping tool or kit of parts according to claim 22 , wherein the tool for creating the recess ( 6) is selected from the group consisting of a drill, an awl, and a punching tool .24 . The form shaping tool or kit of parts according to any one of claims 1 to 23 further comprising a tool for transferring ultrasound to the thermoplastic implant (1 ) , optionally a sonotrode .

25. The kit of parts according to any of claims 3 to 24 , wherein the implant (1 ) is a pin, an implant for tenodesis or a suture anchor, optionally wherein the kit further comprises a suture for use with the suture anchor .

26. The form shaping tool or kit of parts according to any of claims 1 to 25, wherein the form shaping tool comprises a notch (10) extending at least partially from the distal endof the body (3) to the proximal end of the body, the notch (10) being optionally formed in the body (3) and / or the protrusion ( 2 ) .

27. The form shaping tool or kit of parts according to claim 26, wherein the notch forms a cutting edge (9) , the cutting edge (9) being configured to form a recess ( 6) in the hard tissue .

28. The form shaping tool or kit of parts according to any of claims 1 to 27, wherein the form shaping tool has a through- opening extending essentially in direction from the proximal to the distal end of the body (3) , in particular wherein the through-opening extends through the body (3) of the form shaping tool .

29. The kit of parts according to any of claims 3 to 28 further comprising a hardening material (11 ) for orthopedic use, optionally in powder or neat form.

30. The kit of parts according to claim 29, wherein the hardening material (11 ) is a cement, a hydraulic or non-hydraulic cement, a Ca-based cement, a calcium phosphate-based cement, a CaCOs or CaSCy-based cement, a silicate-based ceramic, silicate, borate glass or phosphate glass .31 . A method for implanting an implant ( 1 ) having thermoplastic properties into a hard tissue (5) , the method comprising the following steps :a) providing an implant ( 1 ) having thermoplastic properties and comprising a liquifiable thermoplastic material;bl ) creating a recess ( 6) in a hard tissue (5) with the form shaping tool according to any of claims 1 to 28 suitable for75inserting the implant ( 1 ) , while or followed by creating an indentation ( 7 ) in a sidewall of the recess ( 6 ) , orb2 ) providing a hard tissue ( 5 ) with a recess ( 6 ) suitable for inserting the implant ( 1 ) and creating an indentation ( 7 ) in a sidewall of the recess ( 6 ) in the hard tissue ( 5 ) with the form shaping tool according to any of claims 1 to 28 ; c) inserting the implant ( 1 ) into the recess ( 6 ) while or followed by transmitting ultrasound to the implant ( 1 ) for a time suf ficient to liqui fy at least a part of the liqui fiable thermoplastic material to the extent that at least a part of the liqui fied thermoplastic material ( 8 ) extends into the indentation ( 7 ) .32 . A method for implanting an implant ( 1 ) having thermoplastic properties into a hard tissue ( 5 ) , the method comprising the following steps :a ) providing an implant ( 1 ) having thermoplastic properties and comprising a liqui fiable thermoplastic material ;bl ) creating a recess ( 6 ) in a hard tissue ( 5 ) suitable for inserting the implant ( 1 ) , while or followed by creating an indentation ( 7 ) in a sidewall of the recess ( 6 ) , orb2 ) providing a hard tissue ( 5 ) with a recess ( 6 ) suitable for inserting the implant ( 1 ) and creating an indentation ( 7 ) in a sidewall of the recess ( 6 ) in the hard tissue ( 5 ) ;c) inserting the implant ( 1 ) into the recess ( 6 ) while or followed by transmitting ultrasound to the implant ( 1 ) for a time suf ficient to liqui fy at least a part of the liqui fiable thermoplastic material to the extent that at least a part of the liqui fied thermoplastic material ( 8 ) extends into the indentation ( 7 ) ,76wherein a volume of the indentation ( 7 ) in the sidewall of the recess ( 6 ) is equal to or greater than a volume of the liqui fied thermoplastic material ( 8 ) .33 . A method for implanting an implant ( 1 ) having thermoplastic properties into a hard tissue ( 5 ) , the method comprising the following steps :a) providing an implant ( 1 ) having thermoplastic properties and comprising a liqui fiable thermoplastic material ;bl ) providing a hard tissue ( 5 ) with an opening ( 12 ) or providing a hard tissue and creating an opening ( 12 ) into the hard tissue , followed by filling the opening ( 12 ) at least partially with a hardening material ( 11 ) ; orb2 ) providing a hard tissue ( 5 ) with an opening ( 12 ) at least partially filled with a hardening material ;followed bycreating a recess ( 6 ) in the non-hardened, partially hardened or fully hardened hardening material suitable for inserting the implant ( 1 ) , while or followed by creating an indentation ( 7 ) in a sidewall of the recess ( 6 ) in the hardening material ;c) inserting the implant ( 1 ) into the recess ( 6 ) in the hardening material while or followed by transmitting ultrasound to the implant ( 1 ) for a time suf ficient to liqui fy at least a part of the liqui fiable thermoplastic material to the extent that at least a part of the liqui fied thermoplastic material ( 8 ) extends into the indentation ( 7 ) , wherein a volume of the indentation ( 7 ) in the sidewall of the recess ( 6 ) in the hardening material is equal to or77greater than a volume of the liquified thermoplastic material (8 ) .

34. The method according to claim 33, wherein the non-hardened, fully hardened or partially hardened hardening material ( 11 ) covers a sidewall of the opening ( 12 ) and optionally an indentation in the sidewall of the opening ( 12 ) , and wherein an indentation in the hardening material and / or in the opening ( 12 ) in the hard tissue is created.

35. The method according to any one of claims 31 to 34, wherein the volume of the liquified thermoplastic material (8 ) minus a volume of the recess ( 6) excluding a volume of the indentation (7 ) is equal to or smaller than a volume of the indentation (7 ) ; and / or wherein the volume of the indentation (7 ) in the sidewall of the recess ( 6) is equal to or greater than a volume of the liquifiable thermoplastic material of the implant ( 1 ) .

36. The method according to any one of claims 31 to 35, wherein the indentation (7 ) has a depth to width ratio selected from the list of : less than 2, in the range of 1 to 2 and less than 1 , in particular in a proximal section of the recess .

37. The method according to any one of claims 31 to 36, wherein the indentation (7 ) has a parabolic, sinusoidal, or trapezoidal profile; and / orthe indentation (7 ) has a rounded crest, in particular a crest rounded by a circular arc, optionally a circular arc of 2 x ( 9O°-0) , wherein 0 is the flank angle of the indentation, in particular in a proximal section of the recess .7838. The method according to any one of claims 31 to 37, wherein at least one of the following applies :the hard tissue (5) is a bone,the hard tissue (5) is a cortical bone and / or a spongy bone,the method steps are performed in the given order, or a combination thereof .

39. The method according to any of claims 31 to 38, wherein at least one of the following applies :the recesses ( 6) is created in a bone and is created to reach through the cortex of the bone into the spongy bone;the recess ( 6) has a constant diameter or is tapered in direction from a proximal end to a distal end of the recess ( 6) ;the indentation (7 ) in the sidewall of the recess ( 6) is created in a section of the recess ( 6) in the cortex of the bone only, ora combination thereof .

40. The method according to any of claims 32 to 39, wherein the indentation (7 ) in the sidewall of the recess ( 6) is created with the form shaping tool as defined in any one of claims 1 to 30, and the implant (1 ) is as defined in any one of claims 3 to 30,in particular wherein a volume of the recess ( 6) excluding the indentation (7 ) volume corresponds to the body (3) volume and optionally the indentation (7 ) volume corresponds to the protrusion (2 ) volume .7941 . The method according to claim 40, wherein the form shaping tool and the implant (1 ) are provided as the kit of parts according to any one of claims 3 to 30.

42. The method according to any of claims 31 to 41 , wherein the indentation (7 ) is a thread, optionally a thread created by a form shaping tool as defined in any of claims 2 or 6 to 30.

43. The method according to any of claims 31 to 42, wherein the recess ( 6) has a distal end in the hard tissue, in particular in a spongy bone, or reaches through the hard tissue .

44. The method according to any of claims 31 to 43, wherein the indentation (7 ) is created such that a volume of the indentation (7 ) decreases from a proximal end of the recess ( 6) to a distal end of the recess ( 6) .

45. The method according to any of claims 31 to 44 , wherein the volume of the indentation (7 ) decreases by a factor of 3, optionally 2, from a proximal end to a distal end of the recess ( 6) , optionally over a recess ( 6) that has a depth of 10 mm, optionally 5 mm.

46. The method according to any of claims 31 to 45, wherein an opening of the recess ( 6) has a diameter greater than any other diameter of the recess ( 6) , optionally excluding the indentation (7 ) .

47. The method according to any of claims 31 to 46, wherein the recess ( 6) has a tapered section, in particular a tapered shape, in the direction from a proximal end to a distal end of the recess ( 6 ) .8048. The method according to any of claims 31 to 47 wherein a volume of the recess ( 6) excluding the indentation (7 ) volume is constant or decreases from an opening to a bottom of the recess ( 6) by a factor smaller than a factor by which a volume of the recess ( 6) including the indentation (7 ) volume decreases from the opening to the bottom of the recess ( 6) .

49. The method according to any one of claims 31 to 48 wherein the ultrasound in step c) is transmitted by a sonotrode as defined in or being part of the kit of parts according to any one of claims 1 to 30.

50. The kit of parts according to any of claims 1 to 30 or the method according to any of claims 31 to 49, wherein the hard tissue (5) is a human, animal or artificial hard tissue, optionally a cartilage-covered hard tissue, and optionally wherein the hard tissue (5) is a hard tissue sample outside of the human or animal body, a hard tissue of a dead body or a hard tissue of a human or animal patient or an artificial bone graft material .51 . The kit of parts according to any of claims 1 to 30 or the method according to any of claims 31 to 50, wherein the hard tissue (5) has a reduced bone density, optionally is an osteoporotic bone .

52. The method according to any of claims 31 to 51 , wherein the method is for treatment of a shoulder or cruciate ligament inj ury .8153 . The method according to any of claims 33 to 52, wherein the hardening material (11 ) is as defined in any one of claims 29 or 30.54 . The method according to any of claims 32 to 53, wherein the recess ( 6) is created by the form shaping tool as defined in any one of claims 1 to 30.

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