Device for implant

Abstract

A device and implant having thermoplastic properties for implantation into a hard tissue, in particular a device having an inner volume for receiving the implant and defined openings for liquified parts of the implant to extend out of the inner volume, as well as associated methods of implanting the device and implant into a hard tissue.

Description

[0001] DEVICE FOR IMPLANT

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The current invention relates to devices for implantation into a hard tissue and use together with implants having thermoplastic properties and hardening materials, as well as to associated methods of implantation in the context of orthopedic applications.

[0004] DESCRIPTION OF THE RELATED ART

[0005] For instable or fragile hard tissues, it is known to use support structures together with thermoplastic implants. Such support structures can also direct the flow of liquified thermoplastic implants. Known embodiments of such structures include cylindrical sleeves with openings which can be implanted into hard tissues. These sleeves have openings through which a liquified implant having thermoplastic properties exits the sleeves once ultrasound is applied to the implant in the sleeve. Exemplary support structures are disclosed in US 7, 335, 205 B2 and US 2010 / 0274358 Al.

[0006] SUMMARY OF THE INVENTION

[0007] It is a task of current invention to provide alternative, optionally simplified or improved devices, for implantation together with thermoplastic implants.

[0008] This task is solved by kit of parts with the features of claim 1 and the method of claim 25. Further embodiments of

[0009] PCTthe kit of parts and the method are defined by the features of dependent claims.

[0010] In an aspect, the present invention is directed to a kit of parts comprising an implant having thermoplastic properties and a device for implanting the implant into a hard tissue, the device comprising:

[0011] a body made of at least one body member, optionally at least two or at least three body members, wherein the at least two or at least three body members are at least partially spaced apart,

[0012] wherein the body extends from a proximal end to a distal end along a y-axis and defines an inner volume being suitable for receiving the implant,

[0013] wherein the body comprises at least three apertures between the proximal end and the distal end of the body, wherein a total area of the at least three (e.g. of all the) apertures is equal to or greater than a total surface area enclosing the inner volume between the distal end and the proximal end,

[0014] wherein a proximal section of the body, in particular the proximal end, forms an opening for inserting the implant into the inner volume along the y-axis,

[0015] wherein the device, in particular the body, is configured to or comprises means configured to cause a resistance against the implant being inserted into the inner volume along the y-axis such that upon transmission of ultrasound energy to the implant during or after insertion at least partial liquif ication of the implant occurs and the device

[0016] PCTis configures such that a liquified at least partial volume of the implant extends out of the inner volume through at least one of the at least three apertures, optionally through each aperture.

[0017] 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.

[0018] The implant having thermoplastic properties refers to any object (e.g. implants as exemplified below) that is suitable for implantation into another object, in particular a recess in an object, e.g. in the inner volume of the device inserted into a recess in a hard tissue, 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 object (e.g. the device), whereafter 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

[0019] PCTcorresponding 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. For further exemplary thermoplasts, see, e.g., WO 2012 / 037699, which is incorporated by reference in its entirety, in particular page 6, line 8 to page 9, line 7.

[0020] Exemplary implants include pins, suture anchors (see, e.g., WO 2012 / 037699 ), as well as fasteners combined with implants having thermoplastic properties, e.g. for tenodesis, e.g. prosthetic elements, e.g. as described in WO 2011 / 091545, incorporated by reference in its entirety. For example, fasteners (prosthetic elements) of different shapes and forms can be used together with the implant as described herein to achieve a press - fit connection in a recess by means of the fastener (prosthetic element) and a positive- fit connection by means of the implant used together with the fastener (prosthetic element), e.g. as described in WO 2011 / 091545. For example, the suture anchor may be an essentially cylindrical structure with a length of 4 mm to 20 mm, an outer diameter of 1 mm to 9 mm, and

[0021] PCTwith an optional inner cavity that stretches from a proximal end into the suture anchor towards a distal end over 0.5 mm to 8 mm and having a cavity diameter of 0.2 mm to 8 mm. The inner cavity may be cylindrical or polygonal (prismatic) and / or have a tapered (conus) shape (with the largest diameter at the proximal end of the suture anchor) suitable for a sonotrode to be inserted. The pin as 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 10mm, optional inner cavity depth (from a proximal end into the pin towards a distal end) of 0.5 mm to 10 mm, cavity diameter 0.2 mm to 8 mm. 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.

[0022] The hard tissue can be any hard tissue, in particular a bone. As known to the skilled person, implants are typically implanted into preexisting or purposively created recesses in hard tissues.

[0023] The body of device is formed by the at least one, optionally by at least two or three body members. The "body" as used herein does not refer to a closed structure that has an inside and an outside which would be completely separated by structural means. Rather, the body has apertures as explained further below. The body extends from a proximal end to a distal end of the body along an imaginary y-axis. The body member (s) define (s) and shape the body, in particular the sides of the body, of the device and an inner volume which is located inside of the

[0024] PCTbody. The volume is suitable, i. e. shaped and sized, for receiving an implant having thermoplastic properties. In other words, the skilled person can choose / construct either the body, the implant or both relative to each other such that the implant can be received in the inner volume. The body member (s) of the instant device can be any dimensionally stable component (s) and have any shape.

[0025] However, the body, the device and / or any components thereof such as the body member (s) and / or the means configured to create a resistance may be flexible, pliable. For example, it is not a prerequisite that the body and / or the device are suitable for load bearing applications themselves ( s ) because the combination of the device with a liquified (and resolidified) implant results in a load bearing and load transferring structure when inserted into a hard tissue. The body member (s) may have a solid body or itself comprise openings reaching through the member (s). When more than one body member is present, the members are at least partially spaced apart, which means that they may also overlap or adj oin each other as long as they remain at least partially spaced apart. In an example, the body members can be distinguished visually from one another, e.g. in that they from structurally distinct elements, and, e.g., when adj oining each other show a borderline or connecting line (e.g. a welding / gluing or fastening point or line) between the body elements. In an example, the body members of the instant device do not form a single homogeneous body with pores or openings. Rather, in this example, the body members are distinct elements (e.g. visually distinct elements) which may be interconnected, e.g. by struts,

[0026] PCTbars, links, or circular elements, or forming a net- like structure.

[0027] The body comprises at least three apertures between the proximal end and the distal end. In other words, the apertures are located in the "side (s) " or the "side surface (s) " of the body. In an example, when at least three body members are present, the body members are at least partially spaced apart so as to form, e.g., the at least three apertures in the body (i. e. the apertures are the free spaces between the body members) between the proximal end and the distal end of the body.

[0028] The total area of the at least three apertures refers to the sum of all areas of (all) the apertures comprised in the body between the proximal end and the distal end. This total area is at least equal to or greater than the total surface area enclosing the inner volume between the distal end and the proximal end. In other words, the body has at least the same area opening the inner volume to the outside of the device as it has an area covering or enclosing the inner volume (by structural means) from the outside of the device between the proximal end and the distal end, i. e. in the "side (s) " of the body. The term "surface area enclosing" is to be understood in that this area closes, i. e. structurally delimits, the inner volume vis-à-vis the exterior of the body. The "surface area enclosing" does not mean an entire imaginary surface area enclosing the inner volume but a surface area of all real structural elements physically delimiting the inner volume from the outside. In other words, the total surface area enclosing the inner

[0029] PCTvolume between the distal end and the proximal end particularly refers to the total surface area of the body members that encloses the inner volume, and optionally including the surface area of further structural elements of the device and / or body that enclose the inner volume -the surface refers to that surface which actually delimits the inner volume. One could imagine that the total surface area enclosing the inner volume is the total surface area of physical / structural elements visible from the outside of the device, e.g. the total area of all physical / structural elements projected onto the imaginary surface enclosing the inner volume of the device between the proximal and the distal end of the body.

[0030] The body has an opening for inserting the implant into the inner volume of the body. The opening is formed by a proximal section of the body, optionally by a proximal end of the body. The proximal section of the body is a section of the body along the y-axis that is closer to the proximal end than to the distal end, and lies in an imaginary proximal half of the body (that is closer to the proximal end compared to a (imaginary) distal half of the body in y-direction that is closer to the distal end of the body. ). The (proximal or distal) end, on the other hand, is where the structure of the body ends.

[0031] For example, the proximal section can form a contoured opening, wherein the contour features can be implemented by the body, the body members, the opening member or any structural feature of the device.

[0032] PCTFor example, the body members and / or means for creating a resistance, can form the opening for inserting the implant into the inner volume along the y-axis. The opening may, e.g., be formed by a structural element, e.g. an opening member, that is comprised in the proximal section, optionally proximal end, of the body, which opening member may, e.g., form and / or shape the proximal section, optionally proximal end. The opening member can, e.g., typically connect body members, e.g. at least two or at least three body members, and may be positioned at proximal ends of the body members or further in direction of a distal end of the body members. The opening member may also be suitably shaped to avoid that liquified parts of an implant inserted into or being inserted into the inner volume flow out of the inner volume through the opening member (i. e. in direction of the proximal end and to the outside of the inner volume via the opening), e.g. it may function as a sealing. The opening member may have or form a collar and / or it may be sectioned or circumferential around the opening.

[0033] The device is configured to or comprises means to cause a resistance against the implant being inserted into the inner volume along the y-axis. This resistance causes, upon ultrasound transmission, the liquification of the implant in a position of the implant being in contact with said means for causing a resistance. For example, the resistance can cause a local energy concentration and the means can be energy directors to initiate the liquif ication of a part of the implant. The device may itself cause the resistance, wherein components of the device serve as means to cause a

[0034] PCTresistance (e.g. the body member (2), and / or the opening member, etc. ), and / or the device may be shaped such as to cause a resistance, e.g. having a tapered or cone shape, wherein the diameter of the inner volume is reduced in direction of insertion, e.g. towards the distal end.

[0035] Alternatively or additionally, the device may comprise suitable means which cause a resistance, e.g. in the shape of protrusions reaching into the inner volume or edges (in particular edges running perpendicular to the y-axis) causing a resistance against the implant being inserted into the inner volume. For example, connecting means which connect the body members, in particular positioned essentially perpendicular to the y-axis, can be used as means to cause a resistance. For example, the connecting means connect the body members around a perimeter of the inner volume (i. e. without extending into the inner volume), or through the inner volume.

[0036] The shape of the device or the position of the means can be used to determine where at least a part of the implant liquifies. As liquif ication occurs, the liquified parts can extend out of the inner volume through at least one of the at least three apertures to the outside of the body (i. e. out of the inner volume). If, for example, the outside of the body facing an aperture is closed or covered by a smooth surface (e.g. the surface of a cortex), the liquified parts may flow back into the inner volume and in direction of the distal end, where, for example, the liquified parts may again extend out of the inner volume through a further aperture (or a different section of the same aperture) where, for example, a more porous structure

[0037] PCTis located such as a spongy bone into which the liquified parts can extend into and resolidify. In other words, it may, for example, not only be the structural features of the device which determine where the liquefied part (s) of the implant extend out of the device, but rather, it may be a combination of the device features such as aperture location and site of implantation (what type of tissue -smooth and dense (cortex) or porous (spongy bone) - is opposite an aperture) which defines where the liquified part (s) of the implant extend out of the device.

[0038] In the following, an example of the device for implanting the implant into a hard tissue is described. In this example, the device has a body with a proximal end and a distal end spaced apart from each other along a y-axis. The ends can be rectangular, round, oval or polygonal structures. The distal end may also be a point if the body has a cone shape. The proximal section, optionally the proximal end, forms an opening (i. e. a rectangular, round, oval or polygonal structure that forms an opening) and is suitable for inserting an implant from outside the device into an inner volume that is located inside the body between the proximal end and the distal end of the body. The proximal end and the distal end are connected to each other by at least one, optionally at least two or three, body member (s) which is (are) each attached to the structures forming the distal and proximal ends. When more than one body member is present, the body members are at least partially or completely spaced apart from each other but may be connected to each other (between the proximal and distal ends and in addition to the attachment at these

[0039] PCTends) by further structures, in particular by means configured to cause a resistance against the implant being inserted into the inner volume along the y-axis. In this example, the body members can be identified as the structures connecting the proximal and distal ends which have a component (e.g. a vector component) oriented along the y-axis but may be tilted relative to this axis, e.g. from 0° to 45° or to 89 °, and may overlap with each other. The apertures can be located within the body member (s) or can be located between the body members, and between the proximal end and distal end (i. e. in the "sides" of the body). For example, the body member (s) can be a rod, a column or elongated a rectangular member and / or the device may have a cage- like or net - shaped appearance where the "free space" in the sides of the cage corresponds to the apertures. The total area of the apertures (i. e. the sum of the areas of all apertures in the sides of the body) is at least equal to or greater than the total area of surfaces enclosing the inner volume (i. e. the sum of all the areas enclosing the inner volume, i. e. closed surfaces) and / or than the total area of the body member (s) (i. e. the sum of the areas of all body members enclosing the inner volume). The distal end may be closed, i. e. delimit the interior volume, or it may be open. On the outside of the body, e.g. around the sides and / or at the distal end, further elements can be positioned. For example, a thread can extend around the body for inserting the body into a hard tissue, or the distal end can be configured as a tap, reamer or punching tip to insert the device into a hard tissue.

[0040] PCTIn the kit of parts, the implant and the device may be packaged separately, or the implant may be positioned in the device.

[0041] The recess in a hard tissue can be a preexisting recess, e.g. a fracture, a damaged part of the bone, or an existing recess space, or it can be a recess that is purposively introduced into the hard tissue for treatment purposes such as attaching a ligament to a bone. The recess can also be a passage extending through the hard tissue. 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.

[0042] The dimensions of the device are chosen by the skilled person according to the needs of the specific application. For example, the dimensions are chosen relative to the hard tissue size, a depth and / or diameter of a recess in a hard tissue into which the device should be installed. For example, the device and in particular the body, has a length along the y-axis that corresponds at least to a thickness of a cortex of a bone into which the device should be inserted. Exemplary lengths of the device and / or body include 2 mm to 15 mm, 3 mm to 10 mm or 4 mm to 8 mm. Exemplary diameters or cross - sections of the device and / or body include 1.0 mm to 10 mm, 1.2 mm to 6 mm, or 1.5 to 5 mm.

[0043] The kit of parts described herein optionally further includes instructions for how the parts of the kit are assembled and / or used. For example, the instructions teach how to insert the device into a hard tissue and / or how to

[0044] PCTinsert the implant into the device while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant to the extent that a liquified at least partial volume of the implant extends out of the inner volume of the device through at least one of the at least three apertures, optionally through each aperture. For example, the instructions can include the steps of the method aspect and corresponding embodiments disclosed herein.

[0045] 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, at least one of:

[0046] the at least one body member is an elongated member, the device comprises at least two or at least three body members,

[0047] the device comprises two, three, four, five, six, seven or eight body members,

[0048] the device comprises at least four, five six, seven or eight apertures,

[0049] the total area of the at least three apertures is equal to or greater than a total area of the at least three body members,

[0050] or a combination thereof.

[0051] The total area of the body member (s) in particular refers to the surface of the body member (s) enclosing the inner volume.

[0052] PCTIn 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, at least one of:

[0053] the at least one body member is arranged in parallel along the y-axis, the at least one body member forms a helix around the y-axis or at least one of the at least two or at least three body members forms a helix around the y-axis, optionally wherein the at least two or at least three body members are arranged in parallel to each other along the y-axis,

[0054] the at least one, optionally at least three or each, aperture has an aspect ratio of width perpendicular the y-axis to length along the y-axis of at least 1: 3, 1: 4 or 1: 5,

[0055] a width of the at least one, optionally each, aperture perpendicular the y-axis at is equal to or greater than, optionally 1.5 - times, 2 - times or 3 - times greater than, a width of at least one, optionally of each, body member perpendicular the y-axis,

[0056] the total area of the at least three (e.g. of all) apertures is 1.5 - times, 2 - times or 3 - times greater than the total surface area enclosing the inner volume between the distal end and the proximal end, optionally than the total area of the at least one body member,

[0057] or a combination thereof.

[0058] The at least one body member, or one or more of the at least two or at least three body members, can form a helix

[0059] PCTor a part of a helix, i. e. be helically shaped, around the y-axis, in particular from the proximal to the distal end of the body. This helix can also be described as a screw shape, and it is preferably a regular helix (constant pitch) or it can be a helix with varying pitch. The helix may be right-handed or left-handed. The helix may have a constant radius or it can be a conic helix, particularly if the body is conically shaped, e.g. with a decreasing cross section from the proximal end to the distal end of the body. For example, the body may be tapered (conically shaped) such that the cross - section of the body decreases, gradually or stepwise, from the proximal end to the distal end. As outlined herein, the conic or tapered shape may itself cause the resistance (against the implant) mentioned herein. For example, one or more further body members may interconnect the helix, e.g. to form a net - shaped body. If the body comprises more than one body member, at least one or each body member may be a helix or a part of a helix, and each helix may have the same pitch and / or be radially offset. For example, the helices may intersect, e.g. to form a net - shaped body, e.g. if one or more helices are right-handed and one or more helices are left-handed. Alternatively, the helices may not intersect, and the body may comprise interconnecting body members which interconnect the helices to form a net - shaped body (the interconnecting body members may, e.g., correspond to sections of an imaginary helix which, e.g., may be oppositely handed compared to the helices formed by the body members). Radially offset means that, e.g., the

[0060] PCThelices are congruent, intertwined and have the same axis (y-axis).

[0061] For example, the apertures of the body can be formed by the body members, i. e. can be the free spaces between the intersecting helices and / or between the helices and body members interconnecting the helices. For example, the apertures can all have the same area or have varying areas. For example, the apertures may have a rhomboid shape. For example, at least three of the at least three apertures, optionally at least three apertures in the distal half of the body, optionally at least three apertures which are positioned subcortically in the context of the present methods, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures, optionally of all apertures positioned subcortically, is at least 0.2 to 0.5 mm2.

[0062] As outlined above, also for the example in which the body is net - shaped and / or at least one body member is helically shaped, the opening (in the proximal section of the body) may, e.g., be formed by a structural element, e.g. an opening member, that is comprised in the proximal section, optionally proximal end, of the body, which opening member may, e.g., form and / or shape the proximal section, optionally proximal end. The opening member can, e.g., be circumferential and connect all body members at the proximal end, or it can be sectioned (have gaps along the circumference of the opening) and connect a part of the body members.

[0063] PCTFor the aspect ratio, the width of the aperture refers to the extension perpendicular the y-axis, while the length refers to the extension along the y-axis (see, e.g., Figure 6A). The aspect ratio applies in particular to rectangular apertures. If the extensions of the aperture do not align with the y-axis (or perpendicular to the y-axis), for example in the case of curved or screw- formed apertures, the length is the extension that is the most aligned with the y-axis and / or the longest extension, and the width is the extension perpendicular to the length (see, e.g., Figure 16A). The width refers to the widest extension in width direction and the length refers to the longest extension in length direction.

[0064] If the apertures and body member (s) each have different widths, the comparison of width of the aperture to a width of a body member in particular refers to a comparison between neighboring aperture and body member, or to a comparison between the narrowest aperture and the widest body member.

[0065] 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, wherein at least one of: at least one, optionally each, of the at least three apertures extends along the y-axis in at least a proximal half of the body,

[0066] at least one, optionally each, of the at least three apertures extends over at least 2 mm, optionally at least 4 mm in direction of the y-axis,

[0067] PCTthe at least three apertures have a width of 0.5 mm to 5 mm, optionally 1.0 mm to 4 mm and a length of 2 mm to 14 mm, optionally 3 mm to 7 mm in direction of the y-axis, the ratio of an area of the at least one, optionally of each, of the at least three apertures to a cross - section of the body is at least 2: 1, 3: 1, or 4: 1,

[0068] or a combination thereof.

[0069] For example, at least three of the at least three apertures, optionally at least three apertures in the distal half of the body, optionally at least three apertures which are positioned subcortically in the context of the present methods, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures, optionally of all apertures positioned subcortically, is at least 0.2 to 0.5 mm2. As noted above, the at least three apertures may have a width of 0.5 mm to 5 mm. For the case of apertures with a rhombic or rhomboid shape (see in particular embodiments of a net - shaped body and / or helical body members), the apertures may, e.g., have a largest width (the width is the extension essentially perpendicular to the y-axis) of about 1 mm to 2 mm, optionally 1.0 mm to 1.7 mm and / or a largest length (the length is the extension essentially in direction of the y-axis) of about 2 mm to 3 mm. These values particularly apply for a device with an inner volume of about 1.5 mm to 2.5 mm in cross - section and can be scaled linearly according to the cross - section of the inner volume.

[0070] PCTThe body can have a (imaginary) proximal half in y-direction that is closer to the proximal end compared to a (imaginary) distal half of the body in y-direction that is closer to the distal end of the body. In an example, at least one or all apertures are located in the proximal half of the body and optionally at least one or all apertures extend (e.g. along the y-axis) from the proximal half of the body into the distal half of the body.

[0071] The cross - section of the body is the cross - section perpendicular to the y-axis, and refers to the widest cross - section of the body.

[0072] 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 proximal section of the body comprises an opening member forming the opening, optionally wherein the opening member is a collar.

[0073] 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 opening member connects at least two, at least three or each body members, in particular at proximal ends of the body members, or a combination thereof.

[0074] The optional opening member is comprised in the proximal section, in particular the proximal end, of the body and it may, e.g., form and / or shape the proximal section and / or proximal end. For example, the opening member can connect at least two, at least three, or each body members, e.g. at

[0075] PCTproximal ends of the body members (and be positioned at proximal ends of the body members). The proximal ends of the body members are those ends typically defining the proximal end of the body of the device. The opening member may be positioned at the proximal end of one body member, while one or more other body members may extend beyond the opening member in direction distal to proximal end.

[0076] 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,

[0077] the opening member forms a circular, oval or polygonal, optionally rectangular, opening for inserting the implant into the inner volume along the y-axis.

[0078] 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, at least one of:

[0079] the proximal section of the body and / or the opening member have a tapered shape and / or form a tapered opening along the y-axis in direction from the proximal end to the distal end of the body,

[0080] the proximal section of the body and / or the opening member comprises a thread facing an exterior of the device, or a combination thereof.

[0081] For example, the proximal section of the body and / or the opening member can comprise a thread or a threaded portion facing an exterior of the device which can be, e.g., used

[0082] PCTto screw the proximal section and / or the opening member into an object, in particular a hard tissue, in particular a cortex of a bone. For example, the device may be positioned in a recess in a hard tissue and fixated by means of the thread or threaded portion in the hard tissue, e.g. in a proximal portion of a recess in the hard tissue. A tapered shape or opening means, e.g., that the proximal section of the body, in particular the proximal end of the body, of the device has a cross - section that is narrowed in direction of the distal end, e.g. at least in the proximal section, e.g. over a distance of 4 mm to 10 mm in direction proximal end to distal end.

[0083] The opening member or opening, in particular the tapered opening member or opening, but also the proximal section can, e.g., be a collar and / or used to support the device in a recess in a hard tissue by making physical contact with the hard tissue surrounding the opening / rim of the recess, e.g. a cortex. For example, the proximal section can form a collar that is sectioned circumferentially around the body, i. e. has slots or interruptions within the collar, e.g. allowing for structural flexibility such as a cross -sectional compression. For example, the (optionally tapered) opening member, proximal section and / or opening can make a press - fit with the opening / rim of the recess, or be of a collar shape to "sit" on the surface of the tissue, e.g. in order to stabilize the device in the recess, in particular if the hard tissue structure underneath the opening of the recess does not provide enough stability to support the device. For example, this can be used in the

[0084] PCTmethod described below, wherein the device is implanted such that the proximal end of the body and the opening member (e.g. the tapered opening member or opening) sits flush with or raised with respect to a rim of the recess in the hard tissue, e.g. in that the opening member provides the physical support by interacting with the opening / rim of the recess.

[0085] 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 at least one body member is a member with a circular, oval or polygonal, optionally rectangular, cross - section, e.g. an elongated member, in particular a rod.

[0086] For example, the device may have a cage- like or net- shaped appearance where the "free space" in the sides of the cage corresponds to the apertures formed by the at least one body member or formed between body members which can be circular, oval or polygonal, optionally rectangular, elongated members, in particular rods.

[0087] For example, the at least one or all the body members can have a step-wise or continuously varying cross - section (e.g. essentially perpendicular to the y-axis), which varying cross - section can lead to a change in the cross section of the inner volume, e.g. a cross - section of the inner volume that decreases along the y-axis from the proximal end to the distal end of the body. A step-wise varying cross - section can include the presence of steps or

[0088] PCTprotrusions reaching into the inner volume and, thus, forming means for causing a resistance.

[0089] 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, a cross - section of the inner volume decreases along the y-axis from the proximal end to the distal end of the body.

[0090] For example, the device is configured to cause a resistance against the implant being inserted into the inner volume along the y-axis. This resistance causes, upon ultrasound transmission, the liquification of the implant in a position of the implant encountering a resistance. The device may itself be shaped such as to cause the resistance, e.g. by having a cross - section of the inner volume that decreases along the y-axis, e.g. by having a tapered or cone shape or by comprising discrete steps which steps can feature an edge and / or serve as means for causing a resistance, wherein the diameter of the inner volume is reduced in direction of insertion, e.g. towards the distal end, causing a resistance of the implant during insertion along the y-axis.

[0091] 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 cross - section decreases in a distal half of the body along the y-axis towards the distal end of the body.

[0092] PCTThe geometry of the cross - section can be used to determine the location within the body at which at least a part of the implant liquifies when ultrasound is transmitted to the implant, e.g. when a outer surface of the implant encounters resistance against the body which "narrows down" in direction of the distal end.

[0093] 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,

[0094] the device comprises at least two or at least three body members, wherein at least two body members form helices around the y-axis, wherein the helices are optionally radially offset relative to each other and / or wherein the helices intersect each other and / or wherein the device further comprises interconnecting body members interconnecting the body members forming the helices;

[0095] at least three of the at least three apertures, optionally at least three apertures in the distal half of the body, optionally at least three apertures which are positioned subcortically in the context of the present methods, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures, optionally of all apertures positioned subcortically, is at least 0.2 to 0.5 mm2; and / or

[0096] the at least one body member forms a net - shaped body or the at least two or at least three body members together, optionally together with the interconnecting body members, form a net - shaped body.

[0097] PCTThe body may be, as outlined above, net - shaped, meaning that it can have a lattice- like or web- like appearance with the apertures forming the "voids" (e.g. with a rhomboid shape) in the net structure and the body member forming the structure. The net - shaped form can be obtained with one body member (having apertures), or with multiple body members forming sections of the net which are connected together, for example by helical and optionally interconnecting body members as outlined herein.

[0098] 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 device comprises: at least two helical body members having a helical shape around the y-axis in a first direction of rotation around the y-axis and extending in direction of the proximal to the distal end of the body, in particular wherein the at least two helical body members do not intersect each other, at least two interconnecting body members interconnecting the at least two helical body members, in particular wherein the interconnecting body members are sections of one or more imaginary helix(helices) around the y-axis having a second direction of rotation opposite the first direction of rotation,

[0099] wherein the at least three apertures between the proximal end and the distal end of the body are defined by the helical body members and the interconnecting body members, and wherein the at least three apertures have a rhomboid shape,

[0100] PCTin particular wherein at least three of the at least three apertures, optionally at least three apertures in the distal half of the body, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures is at least 0.2 to 0.5 mm2,

[0101] further in particular wherein the at least two helical body members together with the at least two interconnecting body members form a net - shaped body.

[0102] For example, and for all embodiments disclosed herein, at least three apertures may have a minimum area of 0.1 to 0.5 mm2. The minimum area applies in particular to those apertures, e.g. to at least three apertures, which are positioned subcortically in the context of the present methods.

[0103] For example, at least three or all the apertures may have a maximum area of 10 mm2. The maximum area of the apertures typically depends on the size of the device and / or the volume (size) of the implant that is inserted into the device. For example, the maximum area of 10 mm2is, e.g., applicable when an implant with a diameter of about 2 to 3 mm (e.g. 2.3 mm) is used; for implants with larger diameters, the maximum area can be scaled up linearly. The minimum area, however, is believed to be mostly governed by fluid dynamic effects, and is optionally less or nondependent on the size of the device and / or the implant. For example, the skilled person can verify that the minimum area is sufficiently large by inserting the device into water at, e.g., 37 °C, and inserting the implant into the device while or followed by liquification of the implant to

[0104] PCTverify that efflux of the liquified parts of the implant through the aperture (s) of the device occurs.

[0105] It is also preferred that all the apertures have a similar area, e.g. differ in area by 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less and / or have a minimum area of 0.1 to 0.5 mm2. The similar area of the apertures is particularly preferred in an area of the device which is positioned subcortically, e.g. in the context of the methods disclosed herein. In other words, there may be one or more apertures at the proximal end of the body with a smaller area than indicated because these apertures are typically not or less functionally involved due to their cortical and not subcortical position.

[0106] For example, at least two, optionally three, body members having a helical shape can form same-handed but radially offset helices which preferably do not intersect between the proximal end and the distal end of the body. In an example, the helical body members can be interconnected by further body members positioned between the helical body members (and optionally the proximal and / or distal ends of the body) which further (interconnecting) body members can be sections of imaginary helices which are oppositely handed compared to the helical body members but, e.g., of the same pitch. The interconnecting body members can each be sections of different radially offset but same-handed imaginary helices. In this example, the interconnecting body members do not form a continuous helix (interrupted by the helical body members), but are staggered, i. e. offset in particular in a direction along the y-axis when viewed

[0107] PCTfrom the side of the device. The above embodiment is particularly suitable for generating (multiple) apertures of similar sizes, in particular with at least three apertures or more having a minimum area of 0.1 to 0.5 mm2and / or for increasing or decreasing the aperture area from the proximal to the distal end of the body. For example, the staggering distance (i. e. the offset of the point where two interconnecting body members meet on a (e.g. helical and / or further) body member) can be chosen such as to increase or reduce the aperture area. For example, the staggering distance can vary between the proximal end to the distal end of the body. For example, the staggering distance can be reduced from the proximal end to the distal end of the body, e.g. to reduce the aperture area from the proximal to the distal end, e.g. to increase resistance for the outflowing liquified implant in a distal part of the body, which would support an outflow of the liquified parts of the implant through the larger (and more proximal) aperture areas positioned proximal to the cortical area, e.g. the subcortical area. The same effect could also be achieved by increasing the pitch of helical body members which are regularly and symmetrically arranged and intersect regularly to form x- shaped connections.

[0108] It was found that the similar size distribution, in particular with the mentioned lower area limit, leads to an efficient outflow of liquified material from the inside of the device to the outside, and this improves anchoring of the device with the aid of the implant. For example, as outlined below in the context of the method, the abovedescribed geometry allows for efficient subcortical outflow

[0109] PCTof liquified material and it is preferred that at least three apertures are positioned subcortically in order to provide three fixation points, which provide support against a tilting of the device in a recess.

[0110] It is noted that the helical body members and / or the interconnecting body members may serve as means configured to cause a resistance against the implant being inserted into the inner volume.

[0111] 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 body is compressible, in particular wherein the cross - section of the body is compressible, in perpendicular to the y-axis, in particular wherein at least one of the at least three apertures is configured to allow for a compression of the body, in particular of the cross - section of the body, in particular perpendicular to the y-axis.

[0112] For example, at least one aperture, or an additional void, can form a slot, e.g. extending at least over a part of the distance between the proximal end and the distal end, which slot can allow for compression of the body, in particular of the cross - section, e.g. to adapt the cross - section of the body to the cross - section of a recess into which the device is inserted. Alternatively or additionally, the body can be structured in way (e. g. net - shaped) and / or be made of a flexible material (e.g. a plastic) that allows for compression.

[0113] PCTIn 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 means configured to cause a resistance are selected from

[0114] protrusions extending into the interior volume, optionally from the at least one body member, and

[0115] means positioned between at least two of the at least one body members, optionally means connecting at least two of the at least one body members.

[0116] The protrusions can have any shapes and forms that are suitable for creating a resistance against an implant being inserted into the inner volume, in particular edges, tips, steps, spikes, or other forms that create a small area of resistance which leads to a relatively high pressures and liquification at the point of resistance.

[0117] For example, the means configured to cause a resistance can be means which connect the body members (i. e. connecting means) between the proximal and distal ends of the body. For example, the connecting means connect the body members around a perimeter of the inner volume (e.g. positioned on the inner volume side or on an exterior side of the body), or through the inner volume.

[0118] 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, at least one of:

[0119] PCTthe means configured to cause a resistance are positioned between two of the at least one body members and comprise an edge, optionally an edge extending perpendicular to the y-axis, wherein the edge is configured to cause a resistance against an implant being inserted into the inner volume along the y-axis,

[0120] the means configured to cause a resistance are positioned in between a proximal half and a distal half, or in the distal half of the body,

[0121] the means configured to cause a resistance are formed by the at least one body member, in particular by a an edge of the at least one body member configured to cause a resistance against an implant being inserted into the inner volume along the y-axis,

[0122] or a combination thereof.

[0123] The position of the means configured to cause a resistance is determined by the skilled person, e.g., depending on where the liquified part (s) of the implant should emerge from the device into a surrounding space, e.g. a bone tissue. For example, the means can be positioned such that part (s) of the implant start liquifying immediately after insertion into the device, if, e.g., liquified parts should be allowed to flow down the device. Alternatively, if liquification should be achieved further in direction of the distal end of the body, the means can be positioned further in that direction.

[0124] 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

[0125] PCTaddressed unless in contradiction, the means configured to cause a resistance are further configured to direct a flow of the liquified at least partial volume of the implant upon transmission of ultrasound energy to the implant during or after insertion, in particular a flow within the inner volume of the body and / or optionally a flow in direction of at least one of the at least three apertures. For example, the means configured to cause a resistance can be shaped such that a flow of a liquified part (s) of the implant is physically guided by the means, e.g. in direction of the proximal end of the body to the distal end of the body, and optionally in direction of at least one of the at least three apertures. For example, such means can be suitably shaped, e.g. curved, tracks or slides within the body.

[0126] 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 implant is at least one of:

[0127] configured to be at least partially liquified by ultrasound, and optionally wherein the kit of parts further comprises a sonotrode,

[0128] a pin, an implant for tenodesis or a suture anchor, optionally wherein the kit further comprises a suture for use with the suture anchor,

[0129] or a combination thereof.

[0130] PCTIn 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 implant has a shape that is at least partially complementary to the shape of the inner volume.

[0131] For example, the body and / or the device may comprise protrusions reaching into the inner volume or edges (in particular edges running perpendicular to the y-axis) as means for causing a resistance against the implant being inserted into the inner volume. The implant may be shaped accordingly, e.g. to feature indentations that correspond to the protrusions. Additionally, or alternatively, if the body is tapered, e.g. from the proximal to the distal end, the shape of the implant may follow the tapered shape of the body. In an example, the implant is shaped at least partially complementary to the shape of the inner volume, e.g. complementary to one, multiple or all protrusions or to a tapered shape, such that the implant touches multiple or all the means for causing a resistance (e.g. protrusions or tapered body surface) at the same time when being inserted, which can warrant a simultaneous liquification of the implant at the sites where the implant touches multiple or all means for causing a resistance. In this sense, the term complementary can mean that the implant, or at least a part thereof, can have the negative shape of the inner volume.

[0132] In an embodiment of the kit of parts according to the present invention, which may be combined with any of the

[0133] PCTembodiments of the kit of parts preaddressed or still to be addressed unless in contradiction,

[0134] the body is made of four body members, optionally elongated body members, extending parallel to the y-axis, at least partially spaced apart to form at least four apertures, the body comprises means to configured cause a resistance against the implant, wherein the means connect the four body members in a distal half of the body, and

[0135] the opening member optionally connects the body members in the proximal section, optionally at the proximal end of the body;

[0136] or

[0137] the at least one body member forms a net - shaped body and the proximal section of the body is optionally tapered along the y-axis in direction from the proximal end to the distal end of the body, in particular forms a collar.

[0138] 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 device further comprises means for creating a recess in a hard tissue, optionally at the distal end of the body, optionally a punching tip, a drill, a thread, a reamer or a tap.

[0139] 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, at least one of:

[0140] PCTthe device, or at least one of: the at least one body member, the opening member, the means configured to cause a resistance against the implant, or a combination thereof, is / are made of titanium, steel, zinc, magnesium, alloys thereof, calcium phosphate ceramics, in particular hydroxyapatite, high-performance plastics, in particular polyether ether ketone (PEEK), polyetherketoneketone (PEKK), polyaryletherketone (PAEK), polysulfones (PSU) or polyphenylene sulfides (PPS),

[0141] the distal end of the body comprises at least one, optionally two, openings for guiding through a suture, or a combination thereof.

[0142] For example, the device can be made of magnesium, e.g. fine structures of magnesium and due to the use of the implant having thermoplastic properties together with the device, the device is structurally stabilized by the liquified and resolidified implant in a hard tissue. For example, the skilled person appreciates that it may be advantageous to increase the diameters of the structural parts (e.g. the body members) of the instant device when using high-performance plastics in comparison to metals (e.g. for stability reasons). However, the skilled person further appreciates that plastics have a lower thermal conductivity than metals and, therefore, the aspect ratio of the apertures can, e.g., be made smaller compared to the ratios for metal devices since the liquified implant is less likely to or slower in resolidifying when using plastics for the device.

[0143] PCTIn 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, a surface of the at least one body member and / or of the means configured to cause a resistance, in particular a surface facing the inner volume, is polished or etched to a sub-µm roughness. For example, the polished surface can protect a suture used together with the implant from damage, and / or the etching can assist in osseointegration. In particular, the polished and / or etched surface can be the surface of a body member and / or means configured to cause a resistance made of a metal, in particular titanium, and / or be etched by acid edging.

[0144] 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.

[0145] For example, the hardening material can be filled into a recess in an object into which the device should be inserted. Before the hardening material hardens (completely), the device can be inserted into the hardening material and 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 through the apertures of the device into the non-hardened or partially

[0146] PCThardened, e.g. pasty or viscous, hardening material, and thereby displace the non-hardened or partially hardened hardening material while forming, e.g., roundish and / or soft- edged shapes of liquified and subsequently resolidified implant material which aid in retaining the implant and reduce stress due to the roundish shape.

[0147] 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.

[0148] It is noted that in all aspects and embodiments described herein referring to the insertion of the device into the

[0149] PCThardening material that is non-hardened or partially hardened, the device can be inserted into the hardening material having a viscosity below 10 Pas. For example, the hardening material may, during insertion of the device, be non-hardened to the extent that it is more liquid than pasty, i. e. has a viscosity below 10 Pas. For example, the hardening material may also harden, e.g. to a partially or fully hardened state, when the device is already inserted (but, e.g., maybe the implant is not yet inserted) into the hardening material. Alternatively, if a hardening material is chosen that is, e.g., porous, e.g. with an average pore size of more than 20 µm (referring to either spherical pores or in the case of irregularly shaped pores to their largest extension), the hardening material may have a viscosity greater than 200 Pas, e.g. 200 to 1000 Pas, when the device is inserted.

[0150] 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

[0151] PCTexothermically 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.

[0152] Exemplary hardening materials include biodegradable cements, hydraulic or non-hydraulic cements, e.g. Ca-based cements, e.g. calcium phosphate -based cements, or CaCO3 or CaSO4-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.

[0153] For example, hydraulic cements can be calcium phosphate-based cements (CPC). A CPC, as used herein, refers to any cement 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"

[0154] PCTmay 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- def icient hydroxyapatite, amorphous calcium phosphate, and mixtures thereof. Exemplary CPCs are brushite-, monetite- or hydroxyapatite -based one, two or multicomponent cement systems; Calcium sulf ate -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)

[0155] As known to the skilled person, a hardening material and in particular a cement is typically stored in a 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

[0156] PCTfurther 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.

[0157] 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:

[0158] Component Composition

[0159] Powder phase a-tricalcium phosphate (TCP),

[0160] optionally including 2.5 wt% phosphate monohydrate (MCPM)

[0161] Liquid phase 20 wt% Pluronic F- 127 hydrogel +

[0162] 2 wt% Na₂HPO₄ solution

[0163] Liquid- to -powder ratio 0.35 mL / g to 0.5 mL / g,

[0164] optionally 0.35 mL / g without MCPM and 0.5 mL / g with MCPM

[0165]

[0166] Other exemplary hardening materials include, e.g., a powder phase containing dicalcium phosphate dihydrate (DCPD), tetra - calcium phosphate (TTCP), and dicalcium phosphate

[0167] PCTanhydrous (DCPA) to obtain an apatitic cement with a TTCP and hydroxyapatite (HA) phase.

[0168] 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.

[0169] 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. cannulas. The instrument may also have multiple functions, for example, it may be suitable to create a recess in a hard tissue (e.g. as a punching tool, a tap, a drill, or a reamer, e.g. for a recess in a bone) and / or to create a recess in the hardening material during or after hardening (e.g. as a cannula, a screw or a reamer) while also being configured to administer the hardening material to the site of application (e.g. recess in a hard tissue). For example, creating the recess in the structure formed by the hardening material means in particular that the instrument is kept in the pasty / liquid hardening material until a sufficient degree of setting or hardening of the hardening material is achieved such that the recess created by the volume of the instrument in the hardening material remains when the instrument is removed from the hardening material. Alternatively, the instrument can be used to create a recess in the hardened material. Whether used in pasty or

[0170] PCThardened hardening material, the instrument may create a smooth surfaced recess, or it may create a pattern in the walls of the recess, in particular a pattern that increases the surface area of the recess, e.g. cut-outs, e.g. cutouts with a thread form, e.g. as formed by a reamer or a screw.

[0171] 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 further comprises means for handling and / or implanting the device disclosed herein. The means for handling can, for example, be resilient pliers which can be inserted into the device through the opening and, through internal tension in the pliers, remain attached to the device until the tension is removed and the pliers can be removed from the implant. For example, the means (e.g. pliers) can be an essentially U-shaped instrument with two tips at the ends which can be pressed towards each other to be inserted into the device through the opening of the device. For example, the device can be attached (and ready for handling and implanting) to the means for handling in the kit of parts. For example, the means for handling can be made of any suitable plastic material.

[0172] Alternatively, the means for handling can be any rod- shaped element which can be manually held and establish a press fit with or can be screwed into (e.g. at one end of the means) a part of the inner volume of the device such that the device can be reversibly attached to the means for

[0173] PCThandling and implantation. In another alternative, the means for handling can be a grabber with suitable j aws or claws with which the device can be reversibly held.

[0174] In a further aspect, which may be combined with any of the embodiments and aspects preaddressed or still to be addressed unless in contradiction, the present invention is directed to a method for implanting a device and an implant having thermoplastic properties into a hard tissue, comprising the steps:

[0175] (al) providing a hard tissue with a recess suitable for inserting the device, or

[0176] (a2) providing a hard tissue and creating, optionally drilling, a recess into the hard tissue suitable for inserting the device;

[0177] (b) providing a device as defined herein, in particular a device comprising

[0178] a body made of at least one body member, optionally at least two or at least three body members, wherein the at least two or at least three body members are at least partially spaced apart, wherein the body extends from a proximal end to a distal end along a y-axis and defines an inner volume being suitable for receiving the implant, wherein the body comprises at least three apertures between the proximal end and the distal end of the body, wherein a total area of the at least three (e.g. of all the) apertures is equal to or greater than a total surface area enclosing the inner volume between the distal end and the proximal end, wherein a proximal section of the body, in particular the proximal end, forms an opening for inserting

[0179] PCTthe implant into the inner volume along the y-axis, wherein the device, in particular the body, is configured to or comprises means configured to cause a resistance against the implant being inserted into the inner volume along the y-axis;

[0180] (c) inserting the device into the recess in the hard tissue;

[0181] (d) providing and inserting an implant having thermoplastic properties, in particular as defined herein, through the opening into the device while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant to the extent that a liquified at least partial volume of the implant extends out of the inner volume of the device through at least one of the at least three apertures, optionally through each aperture.

[0182] The definitions and examples relating to the device and implant of the kit of parts provided above apply to the device and implant for use in the present method unless specifically stated otherwise.

[0183] The hard tissue in the present methods is, for example, a bone. The recess in the hard tissue can be a preexisting recess, e.g. a fracture, a damaged part of the bone, or an existing recess space, or it can be a recess that is created in the hard tissue in the context of the present method by suitable and known orthopedic techniques. The recess may also be formed by the device itself, as described further below.

[0184] Typically, and for example, the recess in the hard tissue reaches at least into and / or through the cortical bone, in

[0185] PCTparticular into the spongy bone (trabecular bone) - or even through the entire bone. The dimensions of the recess are typically adapted to the requirements of the orthopedic actions, or are those dimensions already present, e.g., in the case of a fracture. The size and dimensions of the device and implant for use in the present method are chosen by the skilled person, e.g. the surgeon, depending on the needs for the orthopedic action, the bone size, the recess size and / or the characteristics of the bone material around the recess. The dimensions of the implant are chosen based on the size of the device and optionally based on the amount of liquified material that should extend out from the device through at least one aperture. For example, the device and / or body is dimensioned and configured such that it has a length in direction of the y-axis that corresponds at least to the thickness of a cortex around the recess into which the device is implanted. The apertures are, e.g., positioned such that they are located in a section of the device and / or body that is in the cortex section of a bone, or just below a cortex section, and / or are additionally located and / or extend into a section of the device and / or implant that is in the spongy bone or below a cortex section without further bone structure (e.g. diaphysis).

[0186] The expression "inserting the device into the recess" is to be understood as positioning the device at least such that it is spatially at least partially located within the recess in the hard tissue. As noted above, the implant has at least partial thermoplastic properties. In other words, the implant comprises a thermoplastic material which

[0187] PCTimparts thermoplastic properties such that at least a part of the implant can be liquified by the vibrational energy applied to the implant, e.g. via a sonotrode. The energy transfer and liquif ication of the implant in the context of the present methods can be done during its insertion, or subsequent to its insertion depending on the application and the skilled person can routinely chose the suitable moment and means for energy transfer and liquif ication. Liquif ication occurs in particular where the implant encounters a resistance against the device or the means configured to cause a resistance. The liquified (parts of the) implant can flow within the device (in particular in direction of the distal end of the body), out of and back into the device through the apertures as long as at least a part of the liquified material extends out of the inner volume through at least one of the at least three apertures where it resolidifies and fixates the device in the recess in the hard tissue. For example, if a section of or an aperture faces a smooth surface of a recess, the liquified parts may flow out of the aperture and back into the device (be "deflected" by the smooth surface), e.g. flowing in direction of the distal end, where the liquified parts can extend out of a further section of the aperture or a further aperture into an area of the recess where the liquified parts resolidify and fixate the device.

[0188] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the device

[0189] PCTand implant are those defined herein, and / or are provided as the kit of parts as described herein.

[0190] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, at least one of the at least three, optionally each, aperture is positioned to extend from a point of the body located within a cortex of the hard tissue, or from a point of the body located at the interface between a cortex and a spongy bone of the hard tissue, when the device is inserted into the recess in the hard tissue.

[0191] As noted above, the size and dimensions of the body and / or device as well as the size and location of the apertures can be chosen by the skilled person, e.g. such that the aperture is located in a specific area of the recess, e.g. within a cortex or extending from a cortex further into a hard tissue, or from a point of the body located at the interface between a cortex and a spongy bone of the hard tissue.

[0192] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the means configured to cause a resistance against the implant being inserted into the inner volume along the y-axis are positioned in the spongy bone when the device is inserted into the recess in the hard tissue.

[0193] PCTIn other words, in this example, after insertion of the device into the recess in the hard tissue, the means configured to cause a resistance against the implant are positioned such that they are located in a section of the device that is positioned in the spongy bone or below the cortex where no bone structure is present, e.g. diaphysis. In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the device is implanted such that the proximal section of the body, in particular the proximal end of the body, and / or the opening member sits flush with or raised with respect to a rim of the recess in the hard tissue.

[0194] For example, the proximal section of the body, in particular the proximal end of the body and / or the opening member can protect the surface of the hard tissue against mechanical influences, e.g. from a suture that is fixated in the device and extends out from the device through the opening. For example, the proximal section of the body and / or the opening member (e.g. the entire opening) can optionally be tapered. For example, the proximal section of the body and / or the opening member can be used to support the device in a recess in a hard tissue by making physical contact with the hard tissue surrounding the opening / rim of the recess, e.g. a cortex, e.g. by sitting flush with (or raised) a rim / opening of the recess, e.g. to create a press - fit. For example, the (optionally tapered) proximal section of the body and / or the opening member (e.g. the

[0195] PCTentire opening) can make a press - fit with the opening / rim of the recess, e.g. in order to stabilize the device in the recess, in particular if the hard tissue structure underneath the opening of the recess does not provide enough stability to support the device.

[0196] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the device is dimensioned such that a distance between the proximal end and the distal end of the body corresponds at least to the thickness of a cortex in the hard tissue, or wherein the device is dimensioned such that the body extends through a cortex of the hard tissue into a spongy bone of the hard tissue, when the device is inserted into the recess in the hard tissue.

[0197] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the device is configured such that the liquified at least partial volume of the implant extends out of the inner volume of the device through at least one, optionally through each, of the at least three apertures, into a subcortical part of the hard tissue, in particular into a spongy bone; and / or such that at least three apertures, optionally at least three apertures with a minimum area of 0.2 to 0.5 mm2, are positioned in a subcortical part of the hard tissue, in particular in a spongy bone.

[0198] PCTAs outlined above, it is preferred that at least three of the at least three apertures, optionally at least three apertures positioned subcortically and / or in the distal half of the body, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures positioned subcortically is at least 0.2 to 0.5 mm2. In other words, there may be one or more apertures at the proximal end or in the proximal half of the body with a smaller area than indicated because these apertures are typically not or less functionally involved due to their cortical and not subcortical position.

[0199] The relative positions described herein for features and functions of the device all relate to the situation where the device is inserted into the recess in the hard tissue. Of course, the skilled person can adjust the size, dimensions of the device and / or the position and / or size of the features of the device in order to achieve the relative positions, and / or he can adjust the insertion depth of the device in the recess.

[0200] It is particularly advantageous that at least three apertures are positioned subcortically in order to provide three fixation points, which provide support against a tilting of the device in a recess. The skilled person can choose the suitable dimensioned implant based on the hard tissue in which the recess is positioned and / or based on the recess dimensions. For example, in the case of the device comprising at least two helical body members having a helical shape around the y-axis in a first direction of rotation around the y-axis and extending from the proximal

[0201] PCTto the distal end of the body, at least two interconnecting body members interconnecting the at least two helical body members, wherein the at least three apertures between the proximal end and the distal end of the body are defined by the helical body members and the interconnecting body members, and wherein the at least three apertures have a rhomboid shape, as disclosed above, it has been found that this device geometry allows for an advantageous effective melt area (of the thermoplastic implant) via the apertures under the cortex which increases anchoring strength and reduces tilt movements of the device in the recess.

[0202] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction,

[0203] in step (al) or (a2), a hard tissue is provided with a recess that is at least partially filled with a hardening material for orthopedic use;

[0204] or

[0205] the method before step (c) further comprises step (bb) of providing a hardening material for orthopedic use and at least partially filling the recess with the hardening material;

[0206] wherein the device is inserted in step (c) into the hardening material and the implant is inserted in step (d) into the device when the hardening material is in a nonhardened, in particular partially hardened form, in particular in a partially hardened form with a viscosity

[0207] PCTbetween 10 Pas and 1000 Pas, optionally between 10 Pas and 200 Pas; or

[0208] wherein the method further comprises the step of creating, optionally drilling, a recess into the hardened hardening material before or during step (c) and inserting the device into the recess in the hardened hardening material.

[0209] For the hardening material, reference is made to the explanation provided above in the context of the kit of parts which apply to the method as well. As outlined above, 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.

[0210] PCTFor example, when step (d) is carried out when the hardening material is partially hardened or non-hardened, the following occurs: the implant is inserted through the opening into the device while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant to the extent that a liquified at least partial volume of the implant extends out of the inner volume of the device through at least one of the at least three apertures, and the liquified at least partial volume extends into the non- or partially hardened hardening material, displacing a volume thereof and, e.g., forming roundish and / or soft - edged shapes of liquified and subsequently re- solidified implant material which shape aids in retaining the implant and reduces stress due to the roundish shape.

[0211] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the recess in the hard tissue or in the hardening material is created, optionally by punching, screwing, drilling or tapping, by means of the device, wherein the device comprises means for creating the recess in the hard tissue or in the hardening material, optionally at the distal end of the body, optionally a punching tip, a drill, a thread, a reamer or a tap.

[0212] For example, the outside of the body, e.g. around the sides and / or at the distal end, can comprise further elements suitable for creating a recess and / or a geometry in the

[0213] PCTrecess in the hard tissue. For example, a thread can extend around the body for inserting the body into a hard tissue, or the distal end can be configured as a drill, a thread, a tap, a reamer or a punching tip to insert the device into a hard tissue. For example, the distal end can be configured as a drill or a thread with a wider diameter than the body which thread can create a structure in the tissue around the body that is suitable for receiving liquified implant material.

[0214] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the recess in the hardening material is created by an instrument used for at least partially filling the recess in the hard tissue with the hardening material, optionally by a cannula, a screw or a reamer configured to administer the hardening material into the recess in the hard tissue.

[0215] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the proximal section of the body and / or the opening member comprise a thread facing an exterior of the device and the thread is screwed into the hard tissue, optionally the cortex, when inserting the device into the recess in the hard tissue. For example, the proximal section of the body and / or the opening member can comprise a thread or a threaded portion facing an exterior of the device which can be, e.g., used

[0216] PCTto screw the proximal section and / or the opening member into an object, in particular a hard tissue, in particular a cortex of a bone during insertion of the device into the recess, which can further aid in fixating the device in the recess by means of the thread or threaded portion on the proximal section and / or the opening member in the hard tissue.

[0217] In an embodiment of the method or kit of parts according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the hard tissue is a human, animal or artificial hard tissue, optionally a cartilage - covered hard tissue, and optionally wherein the hard tissue 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.

[0218] Exemplary hard tissues and applications of the kit of parts and methods disclosed herein include:

[0219] - All indications wherein structural soft tissues like tendons, ligaments, cartilage, menisci, labrum are reconnected to bone or bridged to create bone- soft tissue contact to ensure healing using tethering structures like sutures or tapes;

[0220] - reinforcement of juvenile bones, in particular correcting deformations by osteotomy or by tethering (e.g. scoliosis of the spine or instable lordosis such as spondylolisthesis, or kyphosis by means of tension belts fastened by suture anchors);

[0221] PCT- stabilizing of non-unions (non-healing bone fractures), e.g. in juvenile patients by supporting the metaphysis of j oints;

[0222] - stabilizing of bone defects such as osteochondrosis dissecans or perthes;

[0223] - augmentation and stabilization by plate-pin- connections of tumor affected or radiated bone tissue;

[0224] - ligament or tendon reconstruction in:

[0225] - shoulder

[0226] - wrist or knee (medial and lateral tendon reconstruction, augmentation of the patella for the lateral or cranial - caudal translation),

[0227] - ankle (lateral or medial ligaments)

[0228] - open or closed wedge osteotomies to correct deformities and to re-align j oints (e.g. knee: tibia plateau, or spine).

[0229] In an embodiment of the method or the kit of parts according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the hard tissue has a reduced bone density, optionally is an osteoporotic bone.

[0230] In an embodiment of the method according to the present invention, which may be combined with any of the embodiments of the method or kit of parts preaddressed or still to be addressed unless in contradiction, the method is for treatment of a shoulder or cruciate ligament injury.

[0231] PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0232] Embodiments of the current invention are described in more detail in the following with reference to the figures. These are for illustrative purposes only and are not to be construed as limiting. It is shown in

[0233] Figs. 1A- 1H exemplary devices disclosed herein;

[0234] Figs. 2A- F exemplary devices disclosed herein;

[0235] Figs. 3A-H exemplary devices disclosed herein;

[0236] Figs. 4A-E exemplary kit of parts and devices;

[0237] Figs. 5A-D examples of using the interaction between the implant and the device;

[0238] Figs. 6A-C exemplary devices disclosed herein;

[0239] Fig. 7 an exemplary device disclosed herein;

[0240] Figs. 8A-C exemplary devices disclosed herein;

[0241] Figs. 9A and 9B exemplary positions of the apertures in the device;

[0242] Figs. 10A and 10B an exemplary mode of action of the device and implant; and

[0243] Figs. 11A-C exemplary devices disclosed herein;

[0244] Figs. 12A- 12O exemplary devices disclosed herein; Figs. 13A and 13B exemplary devices disclosed herein; Figs. 14A and 14B exemplary devices disclosed herein; Figs. 15A-C exemplary devices disclosed herein;

[0245] Figs. 16A and 16B exemplary devices disclosed herein; Figs. 17A and 17B exemplary devices disclosed herein;

[0246] PCTFigs. 18A- 18D exemplary methods disclosed herein; and Figs. 19A- 19C exemplary means for handling the device. DETAILED DESCRIPTION OF THE INVENTION

[0247] Figure 1A to 1H show exemplary devices 2 of the kit of parts and method according to the present invention.

[0248] Although a cylindrical shape is shown, the devices can have any geometrical shape including a cube, cuboid, cone, pyramid or prism shape, wherein the prism can be polygonal. The device 2 has a body 3 which defines an inner volume 4 inside of the body as shown in Figures IB, ID, IF and 1H. The term "surface area enclosing" is to be understood in that this area closes, i. e. structurally delimits, the inner volume vis-à-vis the exterior of the body. The "surface area enclosing" does not mean an entire imaginary surface area defining the inner volume (in Fig.1B, 1D, 1F and 1H depicted as the dotted surface defining the cylindrical inner volume) but a surface area of all real structural elements physically delimiting the inner volume from the outside. In other words, the total surface area enclosing the inner volume between the distal end and the proximal end particularly refers to the total surface area of the body members that encloses the inner volume, and optionally including the surface area of further structural elements of the device and / or body that enclose the inner volume - the surface refers to that surface which actually delimits the inner volume. One could imagine that the total surface area enclosing the inner volume is the total surface area of physical / structural elements visible from the outside of the device, e.g. the total area of all

[0249] PCTphysical / structural elements projected onto the imaginary surface enclosing the inner volume of the device between the proximal and the distal end of the body.

[0250] Figures IB, ID, IF and 1H essentially show that the body is an imaginary body 3 and not a fully enclosed structure which would seal the inner volume 4 from an outside of the body 3. As shown in Figure 1A, the body 3 of the device extends from a proximal end 8 to a distal end 9 along a y-axis. The body 3 is made from at least one body member 5 shown as hashed structures. The body comprises at least three apertures 6, shown in the front of the device for illustration purposes (but may of course be present in the back and / or sides, too). For an example in which the total area of the at least three apertures 6 is equal to or greater than a total area of the at least three body members 5, the total surface of (sum of ) the open spaces (the apertures 6) between the distal end 9 and proximal end 8 is equal to or greater than the total area of (sum of ) all the closed areas (the body member 5). The apertures 6 are positioned between the proximal end 8 and the distal end 9 of the body 3. For example, one (or more) aperture 6 (center) can be configured to stretch from the proximal end 8 to the distal end 9, giving a flexibility to the device that allows for compression, in particular compression of the cross-section of the body. The proximal section 24 of the body 3 forms an opening into the inner volume 4 of the body 3 which is suitable for inserting the implant (not shown) into the inner volume 4 along the y-axis. The opening can form and / or have a circular, oval or polygonal, optionally rectangular shape / opening. The distal end 9 may

[0251] PCTbe an open end, i.e. not covering the inner volume 4 or it may be a closed end covering the inner volume 4. The device 2, in particular the body 3, is configured to cause a resistance against the implant being inserted into the volume or comprise means configured to cause a resistance against the implant being inserted into the inner volume. The means are not explicitly shown in Figure 1A but can, e.g., be protrusions in the body member 5, a shape of the body member 5 which creates a local reduction in body diameter, edges of the apertures or edges positioned in the central aperture 6, or an overall shape of the body 3 and / or device 2 which creates a resistance, e.g. a reduction in diameter of the body 3.

[0252] As shown in Figure 1C, the body 3 of the device can be made from at least three body members 5 shown as hashed structures. The body members 5 are at least partially spaced apart and by being spaced apart at least partially define at least three apertures 6, shown here as the empty spaces between the body members 5. For example, the apertures 6 can stretch from the proximal end 8 to the distal end 9, giving a flexibility to the device that allows for compression, in particular compression of the cross-section of the body. For an example in which the total area of the at least three apertures 6 is equal to or greater than a total area of the at least three body members 5, the total surface of (sum of ) the empty spaces (the apertures 6) between the distal end 9 and proximal end 8 is equal to or greater than the total area of (sum of ) all the hashed areas (the body members 5). The apertures 6 are positioned between the proximal end 8 and the distal

[0253] PCTend 9 of the body 3. The proximal section 24 forms an opening into the inner volume 4 of the body 3 which is suitable for inserting the implant (not shown) into the inner volume 4 along the y-axis. At the distal end 9, there may or may not be a structure connecting the body members 5 (for simplicity, a circle is shown which is optional). The distal end 9 may be an open end, i.e. not covering the inner volume 4 or it may be a closed end covering the inner volume 4. The device 2, in particular the body 3, is configured to cause a resistance against the implant being inserted into the volume or comprise means configured to cause a resistance against the implant being inserted into the inner volume. The means are not explicitly shown in Figure 1C but can, e.g., be protrusions in the body members 5, a shape of the body members 5 which creates a local reduction in body diameter, edges positioned between the body members 5, or an overall shape of the body 3 and / or device 2 which creates a resistance, e.g. a reduction in diameter of the body 3.

[0254] As shown in Figures IE and 1G, the proximal section 24 (e.g. the proximal end 8) of the body 3 can comprise an opening member 7 which partially (Fig. IE, still providing flexibility to the device that allows for compression, in particular compression of the cross-section of the body) or fully (Fig. 1G) connects the at least three body members 5 and forms an opening into the inner volume 4 of the body 3 which is suitable for inserting the implant (not shown) into the inner volume 4 along the y-axis. The opening member 7 can form and / or have a circular, oval or polygonal, optionally rectangular shape / opening.

[0255] PCTFigures 2A to 2F show different examples of how the device 2 (in particular the body 3) can be configured to cause a resistance against the implant being inserted into the inner volume 4 and examples of means 10 configured to cause a resistance against the implant being inserted into the inner volume 4. Although at least three body members 5 are shown, the examples apply mutatis mutandis to devices with any number of body members (e.g. 1, 2, 3, 4 or more than 4 body members). In Figure 2A, the means 10 are exemplified as a structure connecting the body members 5, for example a ring-like structure running around the outer side, i.e. around a perimeter of the body members 5, the body 3 and the inner volume 4. The means 10 create an edge-like structure, in particular an edge extending perpendicular to the y-axis as shown in the Figure, with which edge the implant, when being inserted into the inner volume and while vibrational energy (e.g. ultrasound) is transferred to the implant, can physically interact, causing a resistance and leading to a concentration of energy which causes liquification of the implant starting at the site of resistance (where the implant contacts the means 10). The position of the means 10 relative to the proximal and distal end of the body along the y-axis can be chosen according to the needs, e.g. relative to a position of the device in a hard tissue where the implant should liquify. Figure 2B shows an example where the means 10 for creating a resistance are positioned between the body members 5 connecting the same. The means 10 can be positioned at the same position along the y-axis or at different positions. The means can function in Figures 2B- 2D as explained for

[0256] PCTFigure 2A. Figure 2C shows an example in which the means 10 have a ring- like structure running around the inner side of the body 3, i. e. inside the inner volume 4 and connecting the body members 5. The means 10 can be positioned at the same position along the y-axis or at different positions.

[0257] Figure 2D shows an example for the means 10 in which these are configured as protrusions extending from at least one body member 5 into the inner volume 4 (three are shown, but any number is possible depending on the specific application). The means 10 can be positioned at the same position along the y-axis or at different positions. Figure 2E shows an example of how the device 2, in particular the body 3, can be configured to cause a resistance against the implant being inserted into the inner volume 4 along the y-axis. The body 3 (or the entire device) can have a tapered or cone shape, wherein the diameter of the inner volume 4 is reduced in direction of insertion of the implant along the y-axis towards the distal end 9 of the body 3. At some point along the y-axis, the diameter of the implant and the diameter of the body 3 will be of the same size causing a resistance against the implant being inserted into the inner volume 4 and liquification of the implant starting at the site of resistance (where the implant contacts one or multiple body member(s) 5). In Figure 2F, the body member is a net-shaped body member 5, or multiple body members 5 form a net-shaped body. The means 10 are formed by the body member 5, in particular by edges of the body member (s) that have a horizontal component (the y-axis being considered the vertical axis). The opening member 7 here, and for all other embodiments depicted, is optional.

[0258] PCTFigures 3A to 3H show further examples of the device for use in the present invention. Although at least three body members 5 are shown, the examples apply mutatis mutandis to devices with any number of body members (e.g. 1, 2, 3, 4 or more than 4 body members). As shown in Figures 3A and 3B, the least three body members 5 are at least partially spaced apart, which means that they can be arranged in parallel along the y-axis as shown in Figures 1A, IB and 2A to 2D, but they may also overlap or adjoin each other (as shown in this Figure) as long as they remain at least partially spaced apart. The apertures 6 in this example can also correspond to the free space (s) created by the at least partially spaced apart body members 5. As shown in Figure 3A, the body members 5 can have different shapes, e.g. circular, oval or polygonal, optionally rectangular, in particular rod- shaped and they may be tapered. Figure 3C shows that the opening member 7 forming an opening for inserting the implant does not need to be positioned at the (proximal) ends of the body members 5. Rather, the body members 5 may extend beyond the opening member 7 connecting them, wherein the proximal end 8 of the body 3 coincides with the position of the opening member 7. Figure 3D shows that the proximal section 24 can form the opening (without opening member 7) for inserting the implant. The body members 5 extend to the proximal end 8 of the body 3 which coincides with opening member. Figure 3E shows an example of the device 2 comprising multiple rod-shaped body members 5 between which the apertures 6 are formed. One or more, e.g. ring-shaped, means 10 for causing a resistance can be positioned between or around the body members 5, e.g. at

[0259] PCTthe same or at different positions along the y-axis. Figure 3F shows that the distal end 9 can optionally close off the inner volume 4. Figure 3G shows means 10 for causing a resistance positioned between the body members 5 at different positions along the y-axis. For all the examples described herein, Figure 3H examples that the body 3 can have a cuboid shape, e.g. formed by four body members 5 with apertures 6 positioned between the body members and forming sides of the body 3, and that the opening member 7 can connect some or all body members 5, or be absent (left to right).

[0260] Figures 4A to 4C show side views of the device 2 and the implant 11 of the kit of parts 1 or for use in the method of the present invention. Figure 4A shows that the device 2, i. e. the inner volume 4 and the optional opening member 7, are suitable for receiving the implant 11 by inserting the implant along the y-axis through the opening into the device 2. In this side view, apertures 6, body member (s) 5 and means for causing a resistance 10 are shown. The means 10 can connect two or more body members 5 and / or have an edge- like structure with which the implant, when being inserted into the inner volume and while vibrational energy (e.g. ultrasound) is transferred to the implant, can physically interact, causing a resistance and leading to a concentration of energy which causes liquification of the implant starting at the site of resistance (where the implant contacts the means 10). Figure 4B demonstrates that multiple means 10 for causing a resistance can be installed in the body of the device 2. Figure 4C shows that the distal end of the body of the device 2 can have further

[0261] PCTfunctionalities for inserting the device 2 into a hard tissue. For example, the distal end can comprise or be configured as a tap, reamer or punching tip (as shown) to insert the device 2 into a hard tissue. As shown in Figures 4D and 4E, the distal end 9 of the body can be configured as a screw with a thread 18.

[0262] Figures 5A to 5D exemplify how the implant 11 can be liquified in the device 2 (as an example, the device described in Figures 4A to 4C is used). As shown in Figure 5A, the implant 11 is inserted into the inner volume of the device 2 and vibrational energy (e.g. ultrasound) is transferred to the implant 11. When the implant 11 encounters a resistance against the means 10 a concentration of energy is caused and the implant is liquified (where the implant contacts the means 10) as shown in this Figure. The liquified part(s) of the implant 11 then extend out of the inner volume of the body to an outside of the device through the apertures (these extend out of and optionally into the drawing plane and those extending to the left and right of the device are behind the body member(s) and therefore not depicted). Depending on, e.g., the volume of the implant, the size of the device, the amount of energy transferred to the implant and / or the speed of insertion of the implant, the liquified implant may also flow further in direction of the distal end of the body where it can also extend out from the device, as shown in Figure 5B. Figure 5C shows an example in which the device 2 comprises two means 10 configured to cause a resistance against the implant 11 being inserted. In this example, the liquified part(s) of the implant 11

[0263] PCTextend out of the inner volume through apertures between the means 10. As explained in the context of Figure 5B, Figure 5D shows that the liquified implant 11 may also flow further in direction of the distal end of the body where it can also extend out from the device 2 through the apertures.

[0264] Figures 6A and 6B illustrate how the aspect ratio of the apertures 6 is defined. The length 13 of the apertures 6 is the extension which aligns most with the y-axis, while the width 12 of the apertures 6 is the extension which aligns most with an axis perpendicular to the y-axis. The Figures further illustrate the same definitions relative to the y-axis for the width 14 of the body members 5 and how the cross-section 17 of the body 3 is defined. The total area of the at least three apertures 6 is the total area (sum of ) the open areas between the proximal end 8 and the distal end 9 of the body. The area enclosing the inner volume between the proximal end 8 and the distal end 9 is the sum of all areas of the body member(s) 5 including any other members enclosing the inner volume such as the means 10 in this Figure, i. e. the sum of all hashed and solid black areas between the proximal end 8 and the distal end 9. As shown in Figure 6C, the body can be divided into a proximal half 15 which is the half closer to the proximal end 8 and a distal half 16 which is the half closer to the distal end 9.

[0265] Figure 7 shows an example of a device 2 which has a proximal section 24 and / or opening member 7 that comprises a thread 18 facing an exterior of the device. The proximal

[0266] PCTsection 24 and / or opening member 7 can be circular, oval or polygonal and / or tapered as shown in Figure 8. The thread 18 can also extend around (parts of ) the body. For example, the thread 18 can be, e.g., used to screw the proximal section 24 and / or opening member 7 into an object, in particular a hard tissue, in particular a cortex of a bone. For example, the device 2 may be positioned in a recess in a hard tissue and fixated by means of the thread 18 on the opening member 7 in the hard tissue, e.g. in a proximal portion of a recess in the hard tissue. The proximal section 24 and opening member 7 are used in Figure 7 and 8 interchangeably to highlight that both components can have the same functions.

[0267] Figure 8A shows in a top / side view that the proximal section 24 and / or opening member 7 can also be tapered, in particular from a proximal end 8 in direction of the y-axis, and / or form a collar (see Figure 8C). For example, the tapered shape can further assist in either reflecting a tapered recess in a hard tissue and / or aid in keeping a portion of the proximal section 24 and / or opening member 7 outside of the recess, in particular if the tapered shape is a collar, which can in turn mechanically protect the hard tissue surface against a suture extending out from the device 2 through the proximal section 24 and / or opening member 7. Also, a tapered shape or a collar can sit on the cortex and thereby support the device's positioning.

[0268] Figures 8B and 8C show in side views how the proximal section 24 and / or the opening member 7 (tapered in Figure 8B, as a collar in Figure 8C, a combination is also

[0269] PCTpossible) can be used to support the device in a recess in a hard tissue by making physical contact with the hard tissue surrounding the opening / rim of the recess, e.g. a cortex. For example, the (optionally tapered in direction form the proximal end 8 to the distal end 9, or collar-shaped) proximal section 24 and / or opening member 7 can make a press - fit with (tapered shape, Figure 8B) and / or "sit" on top (Figure 8C) of the opening / rim of the recess, e.g. in order to stabilize the device in the recess, in particular if the hard tissue structure 20 underneath the opening of the recess does not provide enough stability to support the device.

[0270] Figures 9A and 9B illustrate that the position and / or extension of the apertures 6 in the device 2 can be chosen relative to the features of the recess into which the device is implanted. For example as shown in Figure 9A, at least one aperture 6 is positioned to extend from a point of the body of the device located within the cortex 19 of the hard tissue, in particular along the y-axis to a point of the body that is positioned in the spongy bone 20. In an alternative example, and as shown in Figure 9B, at least one aperture 6 is positioned to extend from a point of the body located at the interface between the cortex 19 and the spongy bone 20 of the hard tissue, thus also extending into a region of spongy bone.

[0271] Figures 10A and 10B show that the exact positioning of the apertures 6 (and / or the means 10 for creating a resistance) within the body of the device is not necessarily decisive for controlling where the liquified implant 11 extends out

[0272] PCTfrom the device 2. Figure 10A shows how an implant 11 is inserted into a device of the invention through the opening member while vibrational energy is transferred to the implant 11. The implant 11 may already start liquif ication in a proximal half of the body of the device and extend out of the apertures (curved arrows) shown in the cortex 19 section of the recess. However, due to the dense nature of the cortex 19, the surface of the recess in the cortex 19 is smooth and can reflect the liquified implant back through the aperture 6 (curved arrows) into the inner volume of the body. The liquified implant then flows in direction of the distal end of the body along the y-axis where it reaches and extend through further apertures (straight arrows) located in the less dense spongy bone 20, into which the implant can further extend. The result of this is shown in Figure 10B, where the liquified implant fixates the device by extending out of the inner volume through at least one aperture into the spongy bone 20.

[0273] Figures 11A-C show different views of an exemplary device disclosed herein. Figure 11A shows a side view of an exemplary device 2 disclosed herein. The opening member 7 connects the body members 5 at the proximal end to form a circular opening. As shown in Figure 11B (side / top view of the device 2), the means 10 for creating a resistance are present as structures with edges connecting the body members 5, as well as protrusions extending into the inner volume from the body members, wherein the protrusions extend further into the inner volume from the proximal to the distal end of the body. For example, the device can be made from titanium. Figure 11C shows a top view of the

[0274] PCTdevice 2, detailing the protrusions which form the means 10, the body members 5 and the apertures 6.

[0275] Figures 12A and 12B respectively show a side and a side / top view of an exemplary device 2 disclosed herein. The body member 5 can be net - shaped and include the apertures 6, or multiple body members 5 can be helically shaped and / or interconnected and, e.g., form a net - like structure with the apertures 6 in between. For example, the apertures may be of a rhomboid shape. Due to their shape, the body member (s) 5 can also act as means for creating a resistance. The opening member 7 connects the body member (s) at the proximal end to form the opening. For example, the device can be made from titanium. In Figures 12C and 12D show different views of another example of the device, wherein the device has a net - shaped body member 5 or comprises multiple body members which from radially offset helices which can intersect and / or be interconnected. Depending on how the device is manufactured and / or on the point of view, these examples comprise multiple body members (helices) or a single body member with apertures; in any case, the resulting structure is the same. The proximal section 24 of the body is tapered and "sectioned" to allow for a compression of the cross - section of the body and / or for a resistance to occur against an implant being inserted. For all aspects and embodiments, the sectioned proximal section 24 can also be described as a sectioned opening member 7 which can connect body members, e.g. two as shown, and may extend in direction of a distal end of the body members. The sectioned proximal section 24 can also be described as a forming a sectioned

[0276] PCTcollar. Although not shown, the proximal section may also comprise a non - sectioned opening member instead of the sectioned proximal section. The means 10 can be formed by the body member 5, in particular by edges of the body member that have a horizontal component (the y-axis being considered the vertical axis) and / or by the tapered shape of the body in direction of the y-axis.

[0277] Figures 12E and 12F show different views of another example of the device, wherein the body has a net - shape created by multiple body members 5 which are connected (as illustrated by seams between the body members in this Figure) to yield helical strands of body members. The proximal section 24 of the body is tapered and "sectioned" to allow for a compression of the cross - section of the body. Although not shown, the proximal section may also comprise a nonsectioned opening member instead of the sectioned proximal section. The means 10 can be formed by the body members 5, in particular by edges of the body members that have a horizontal component (the y-axis being considered the vertical axis) and / or by the tapered shape of the body in direction of the y-axis. The above can also be applied to devices having a body with a net - shape as shown in Figures 12J, 12L, and 120.

[0278] Figure 12G shows two different views of a device 2 having a net- shaped body as described for Figures 12C- 12F with a proximal section 24 that is slightly tapered and "sectioned". In this example, there is no collar at the proximal section. For all aspects and embodiments, the sectioned proximal section 24 can also be described as a

[0279] PCTsectioned opening member 7 which can connect body members, e.g. two as shown, and may extend in direction of a distal end of the body members. As shown here, the proximal section 24 can be described as an opening member 7 which is sectioned (has gaps along the circumference of the opening) and connects a part of the body members. In this example, the opening member does not have or does not form a collar. The above can also be applied to devices having a body with a net- shape as shown in Figures 12J, 12L, and 120.

[0280] Figure 12H exemplifies for two views of the device 2 that the proximal section 24 can form a contoured opening, wherein the contour features can be implemented by the body, the body members, the opening member 7 or any structural feature of the device. The opening may, e.g., be formed by the opening member 7, which, as shown here, may not have or form a collar but be circumferential. A circumferential opening member may increase the stiffness of the device, e.g. if materials are used for manufacturing the device which require the stiffening at the opening in order to have improved mechanical resilience. The above can also be applied to devices having a body with a net - shape as shown in Figures 12J, 12L, and 120.

[0281] Figure 121 further exemplifies the helical structure of body members 5. For illustration purposes, body members 5', 5'' and 5''' are presented with different patterns to show their helical shape and a schematic helix is shown on the left. These body members 5', 5'' and 5''' may be identical in their material or different. The body members are helically shaped around the y-axis in direction of the

[0282] PCTproximal to the distal end of the body. The helices could also be described as screws, and in this example are regular helices (constant pitch), however, the helices could also have a varying pitch. The helix could have a constant radius but, in this example, conic helices are shown, leading to a conically shaped body with a decreasing cross - section from the proximal end to the distal end of the body. The conic or tapered shape may itself cause the resistance (against the implant) mentioned herein. Each helix shown in this example is radially offset relative to the other helices. In this example, the helices intersect and form a net - shaped body. For example, one or more further (interconnecting) body members may interconnect the body members which form a helix (not shown). The apertures of the body in this example are formed by the body members, i. e. are the free spaces between the intersecting helices. The apertures 6 have a rhomboid shape. For example, at least three apertures, optionally all apertures intended to be positioned subcortically, may have a minimum area of 0.2 to 0.5 mm2.

[0283] Figure 12 J and Figure 12K show two further examples of net-shaped devices 2 which can be described as having helical body members 5. Although not shown, the proximal section 24 of the body can also be "sectioned", e.g. as shown in Figs.

[0284] 12C, 12D, 12E, 12F and 12G. The apertures 6 have a rhomboid shape and a length 13 and width 14. In Figure 12 J, the body members 5 form helices, wherein some body members form right-handed and other body members form left-handed helixes (in this example: three right-handed and three left-handed helix- shaped body members, however, this number

[0285] PCTof body members is exemplary and non - limiting), e.g. of the same pitch, which are radially offset and which intersect. Two exemplary helices are highlighted in the same device depicted in Figure 12L. In Figure 12K, the body members 5 form same-handed, radially offset helices (here right-handed helices when viewed along the y-axis, however, these could also be left-handed helices). These helices preferably do not intersect between the proximal end and the distal end of the body. The same-handed helices 5 (S ' / S1 1in Figure 12M) are interconnected by interconnecting body members 55. As highlighted in Figure 12M for the same device, the interconnecting body members 55 can be described as sections of imaginary helices which are oppositely handed compared to the helical body members 5' / 5'' but, e.g., of the same pitch. In this example, the interconnecting body members 55 do not form a continuous helix (interrupted by the helical body members), but are staggered, i. e. offset in particular in a direction along the y-axis when viewed from the side of the device as shown in this Figure.

[0286] Figures 12N and 120 visualize how the different net - shapes and / or helical configurations of the devices shown in Figures 12J to 12M have an effect on the aperture 6 area (striped area) directly under the cortex (under the dotted line) when the device is inserted into a recess 22 in a hard tissue 23. The device shown in Figure 12N corresponds to the device described for Figures 12J and 12L, and the device shown in Figure 120 corresponds to the device described for Figures 12K and 12M. As can be seen in Figures 12N and 120, the design of the net of the net-

[0287] PCTshaped body, and / or the design of the helical body members (and interconnecting body members) can influence the aperture area in a subcortical area. For example, the replacement of X- shaped connections (resulting from symmetrically intersecting helices) in the device of Figure 120 by staggered interconnecting body members 55 (e.g. as sections of imaginary helices) enhances the aperture area. For example, and for all embodiments and aspects disclosed herein with helical body members and / or a net - shaped body, the staggering distance 26 (i. e. the offset of the point where two interconnecting body members meet on a (e.g. helical and / or further) body member) can be chosen such as to increase or reduce the aperture area. For example, the staggering distance 26 can vary between the proximal end to the distal end of the body. For example, the staggering distance 26 can be reduced from the proximal end to the distal end of the body, e.g. to reduce the aperture area from the proximal to the distal end, e.g. to increase resistance for the outflowing liquified implant in a distal part of the body, which would support an outflow of the liquified parts of the implant through the larger (and more proximal) aperture areas positioned proximal to the cortical area, e.g. the subcortical area.

[0288] For example, if the net - shape of the body is regular and rotationally symmetrical (around the y-axis), e.g. due symmetrically arranged helices / body members which, e.g., intersect regularly to form x- shaped connections (e.g. as shown in Figures 12C, 12D, 12E, 12F, 12G, 12H, 12J and 12L) the area of the apertures and the length of the apertures available for subcortical efflux of the implant typically

[0289] PCTand for a maj ority of the apertures varies homogeneously from the proximal to the distal end of the body depending on the cortex thickness. With the staggered arrangement of the interconnecting body members (e.g. as shown in Figures 12K, 12M and 120), the aperture area can be varied along the y-axis (by increasing or decreasing the staggering distance 26), e.g. to maximize efflux of the implant where desired, e.g. subcortically. A reduction in aperture area from the proximal to the distal end can, e.g., increase resistance for the outflowing liquified implant in a distal part of the body, which would support an outflow of the liquified parts of the implant through the larger (and more proximal) aperture areas positioned proximal to the cortical area, e.g. the subcortical area. The same effect could also be achieved by increasing the pitch of helical body members which are regularly and symmetrically arranged and intersect regularly to form x- shaped connections.

[0290] Figures 13A and 13B respectively show a side and a side / top view of an exemplary device 2 disclosed herein. In this example, the opening in the proximal end is formed by the proximal section 24 of the body and partially by the means 10 for creating a resistance. Depending on how the means 10 are configured, e.g. in particular if they connect at least two body members 5, the means 10 can also be considered an opening member. For example, the device can be made from titanium.

[0291] Figures 14A and 14B respectively show a side and a side / top view of an exemplary device 2 disclosed herein. The body member 5 are spaced apart to form the apertures 6 in

[0292] PCTbetween. The means 10 for creating a resistance are positioned between the body members 5, connecting the same, and forming an edge that is essentially perpendicular to the y-axis. The opening member 7 connects the body members at the proximal end to form the opening. It is also envisioned that the opening member only connects two of the body members, or is absent, in which case the proximal section of the body forms the opening and may be tapered as shown. For example, the device can be made from titanium.

[0293] Figures 15A-C show different views of an exemplary device disclosed herein. Figure 15A shows a side view of an exemplary device 2 disclosed herein. Figure 15B shows a side view, and Figure 15C shows a top view of an exemplary device 2 disclosed herein. The body members 5 are either parallel structures or twisted structures that are connected at the proximal end of the body by the opening member 7. It is also envisioned that the opening member only connects two of the body members, or is absent, in which case the proximal section of the body forms the opening and may be tapered as shown. The apertures 6 are formed between the body members 5. The means 10 for creating a resistance are positioned in the inner volume and are attached to the body members 5 in a helical arrangement. The means 10 configured to cause a resistance are further configured to direct a flow of the liquified at least partial volume of the implant upon transmission of ultrasound energy to the implant during or after insertion, in particular a flow within the inner volume of the body in direction of the distal end. For example, the device can be made from a plastic.

[0294] PCTFigures 16A and 16B respectively show a side and a side / top view of an exemplary device 2 disclosed herein. The body members 5 have curved structures and the apertures 6 are formed in between the body members 5. Due to their shape, the body members 5 also act as means for creating a resistance. The opening member 7 connects the body members at the proximal end to form the opening. It is also envisioned that the opening member only connects two of the body members, or is absent, in which case the proximal section of the body forms the opening and may be tapered as shown. For example, the device can be made from a plastic. The length 13 of the apertures 6 is the longest extension (e.g. which also aligns most with the y-axis) while the width 12 of the apertures 6 is the extension perpendicular to the length (e.g. which aligns most with an axis perpendicular to the y-axis). The width and lengths of the body members are defined in analogy.

[0295] Figures 17A and 17B respectively show a side and a side / top view of an exemplary device 2 disclosed herein. The body member 5 are spaced apart to form the apertures 6 in between. The means 10 for creating a resistance are positioned in the body members 5, in the form of notches that create surfaces which create a resistance against the implant being inserted. The opening member 7 connects the body members 5 at the proximal end to form the opening. It is also envisioned that the opening member only connects two of the body members, or is absent, in which case the proximal section of the body forms the opening and may be tapered as shown. For example, the device can be made from a plastic.

[0296] PCTFigures 18A- 18D show steps of a method of the present invention, wherein a hardening material 21 for orthopedic use is used. Fig. 18A shows a hard tissue 23 with a recess 22 that was preformed or created in the context of the present method. A hardening material 21 is then provided and at least partially filled into the recess 22, as shown in Fig. 18B. While the hardening material is still nonhardened or partially hardened, a device 2 as defined herein is provided and inserted into the hardening material as shown in Fig. 18C. Again, while the hardening material is still non-hardened or partially hardened, an implant 11 having thermoplastic properties as defined herein is provided, and inserted through the opening into the device 2, as shown in Fig. 18D, while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant 11 to the extent that a liquified at least partial volume of the implant extends out of the inner volume of the device 2 through at least one of the at least three apertures into the non-hardened or partially hardened hardening material, thereby displacing a volume of the hardening material, and resolidifying. When displacing the non-hardened or partially hardened hardening material, the liquified parts of the implant can form, e.g., roundish and / or soft- edged shapes, and subsequently re- solidify, which aids in retaining the implant and reducing stress due to the roundish shape.

[0297] The steps described in the context of Figs. 18A- 18D can also be carried out such that the device and / or the implant are inserted when the hardening material is (fully) hardened, which, e.g., can be accompanied by creating a

[0298] PCTrecess in the hardened hardening material before inserting the device.

[0299] Figures 19A to 19C show different exemplary means 25 for handling the device 2 disclosed herein, which may be part of the kit of parts disclosed herein. As shown in Figures 19A and 19B, the means 25 for handling and / or implanting the device 2 can, for example, be resilient pliers which can be inserted into the device through the opening and, through internal tension in the pliers, remain attached to the device until the tension is removed and the pliers can be removed from the implant. For example, the means 25 can be an essentially U- shaped instrument with two tips at the ends which can be pressed towards each other to be inserted into the device 2 through the opening of the device 2. For example, the device 2 can be attached (and ready for handling and implanting) to the means 25 for handling in the kit of parts. For example, the means for handling 25 can be made of any suitable plastic material.

[0300] Alternatively, as shown in Figure 19C, the means 25 for handling can be a rod- shaped element which can be manually held and establish a press fit with or can be screwed into (e.g. at one end of the means) a part of the inner volume of the device 2 such that the device 2 can be reversibly attached to the means 25 for handling and implantation.

[0301] PCTREFERENCE SIGNS LIST

[0302] 1 Kit of parts 12 Width of aperture 2 Device for implanting 13 Length of aperture the implant 14 Width of body member 3 Body 15 Proximal half

[0303] 4 Inner volume 16 Distal half

[0304] 5 Body member 17 Cross - section of the 5 ' Body member body

[0305] 5 ' ' Body member 18 Thread

[0306] 5 ' ' ' Body member 19 Cortex

[0307] 55 Body member 20 Spongy bone

[0308] ( interconnecting) 21 Hardening material 6 Aperture 22 Recess

[0309] 7 Opening member 23 Hard tissue

[0310] 8 Proximal end 24 Proximal section of 9 Distal end the body

[0311] 10 Means configured to 25 Means for handling cause a resistance 26 Staggering distance 11 Implant having

[0312] thermoplastic

[0313] properties

[0314] PCT

Claims

1. CLAIMS1. A kit of parts (1) comprising an implant (11) having thermoplastic properties and a device (2) for implanting the implant into a hard tissue, the device comprising:a body (3 ) made of at least one body member (5), optionally at least two or at least three body members, wherein the at least two or at least three body members are at least partially spaced apart,wherein the body extends from a proximal end (8) to a distal end (9 ) along a y-axis and defines an inner volume (4) being suitable for receiving the implant,wherein the body comprises at least three apertures (6) between the proximal end and the distal end of the body, wherein a total area of the at least three apertures is equal to or greater than a total surface area enclosing the inner volume between the distal end and the proximal end, wherein a proximal section (24) of the body forms an opening for inserting the implant into the inner volume along the y- axis,wherein the device is configured to or comprises means (10) configured to cause a resistance against the implant being inserted into the inner volume along the y-axis such that upon transmission of ultrasound energy to the implant during or after insertion at least partial liquif ication of the implant occurs and the device is configures such that a liquified at least partial volume of the implant extends out of the inner volume through at least one of the at least three apertures, optionally through each aperture.

2. The kit of parts (1) according to claim 1, wherein at least one of:the at least one body member (5) is an elongated member, the device (2) comprises at least two or at least three body members,the device (2) comprises two, three, four, five, six, seven or eight body members,the device comprises at least four, five six, seven or eight apertures ( 6 ),the total area of the at least three apertures is equal to or greater than a total area of the at least three body members, or a combination thereof.

3. The kit of parts (1) according to claim 1 or 2, wherein at least one of:the at least one body member (5) is arranged in parallel along the y-axis, the at least one body member forms a helix around the y-axis or at least one of the at least two or at least three body members forms a helix around the y-axis, optionally wherein at least two of the at least two or at least three body members are arranged in parallel to each other,the at least one, optionally at least three or each, aperture (6) has an aspect ratio of width perpendicular the y-axis to length along the y-axis of at least 1: 3, 1: 4 or 1: 5,a width of the at least one, optionally each, aperture perpendicular the y-axis at is equal to or greater than, optionally 1.5 - times, 2 - times or 3 - times greater than, awidth of at least one, optionally of each, body member perpendicular the y-axis,the total area of the at least three apertures is 1.5 - times, 2 - times or 3 - times greater than the total surface area enclosing the inner volume (4) between the distal end and the proximal end, optionally than the total area of the at least one body member,or a combination thereof.

4. The kit of parts (1) according to any of claims 1 to 3, wherein at least one of:at least one, optionally each, of the at least three apertures (6) extends along the y-axis in at least a proximal half of the body (3 ),at least one, optionally each, of the at least three apertures extends over at least 2 mm, optionally at least 4 mm in direction of the y-axis,the at least three apertures have a width of 0.5 mm to 5 mm, optionally 1.0 mm to 4 mm and a length of 2 mm to 14 mm, optionally 3 mm to 7 mm in direction of the y-axis,the ratio of an area of the at least one, optionally of each, of the at least three apertures to a cross - section (17) of the body is at least 2: 1, 3: 1, or 4: 1,or a combination thereof.

5. The kit of parts (1) according to any of claims 1 to 4, wherein the proximal section (24) of the body comprises an opening member (7) forming the opening, optionally wherein the opening member is a collar.

6. The kit of parts (1) according to claim 5, wherein the opening member connects at least two, at least three or each body members, in particular at proximal ends of the body members.

7. The kit of parts (1) according to claims 5 or 6, wherein the opening member forms a circular, oval or polygonal, optionally rectangular, opening for inserting the implant into the inner volume along the y-axis.

8. The kit of parts (1) according to any of claims 1 to 7, wherein at least one of:the proximal section (24) of the body and / or the opening member have a tapered shape and / or form a tapered opening along the y-axis in direction from the proximal end (8) to the distal end (9 ) of the body (3 ),the proximal section of the body and / or the opening member comprises a thread facing an exterior of the device,or a combination thereof.

9. The kit of parts (1) according to any of claims 1 to 8, wherein the at least one body member (5) has a circular, oval or polygonal, optionally rectangular, cross - section.

10. The kit of parts (1) according to any of claims 1 to 9, wherein a cross - section (17) of the inner volume (4) decreases along the y-axis from the proximal end (8) to the distal end (9 ) of the body (3 ).

11. The kit of parts (1) according to claim 10, wherein the cross - section (17) decreases in a distal half (16) of the body (3 ) along the y-axis towards the distal end (9 ) of the body.

12. The kit of parts (1) according to any of claims 1 to 11, whereinthe device (2) comprises at least two or at least three body members, wherein at least two body members form helices around the y-axis, wherein the helices are optionally radially offset relative to each other and / or wherein the helices intersect each other and / or wherein the device further comprises interconnecting body members interconnecting the body members forming the helices, optionally wherein the device comprises at least two helical body members having a helical shape around the y-axis in a first direction of rotation around the y-axis and extending in direction of the proximal (8) to the distal (9 ) end of the body (3 ), in particular wherein the at least two helical body members do not intersect each other, at least two interconnecting body members interconnecting the at least two helical body members, in particular wherein the interconnecting body members are sections of one or more imaginary helix (helices) around the y-axis having a second direction of rotation opposite the first direction of rotation, wherein the at least three apertures (6) between the proximal end and the distal end of the body are defined by the helical body members and the interconnecting body members, and wherein the at least three apertures have a rhomboid shape;at least three of the at least three apertures, optionally at least three apertures in the distal half (16) of the body, have a minimum area of 0.2 to 0.5 mm2, optionally an average area of all of the at least three apertures (6) is at least 0.2 to 0.5 mm2; and / orthe at least one body member (5) forms a net - shaped body (3 ) or the at least two or at least three body members forming helices together, optionally together with the interconnecting body members, optionally the at least two interconnecting body members, form a net - shaped body.

13. The kit of parts according to any of claims 1 to 12, wherein the body (3 ) is compressible, in particular wherein the cross - section (17) of the body is compressible, in perpendicular to the y-axis, in particular wherein at least one of the at least three apertures (6) is configured to allow for a compression of the body, in particular of the cross - section of the body, in particular perpendicular to the y-axis.

14. The kit of parts (1) according to any of claims 1 to 13, wherein the means (10) configured to cause a resistance are selected fromprotrusions extending into the interior volume (4), optionally from the at least one body member (5), and means positioned between at least two of the at least one body members, optionally means connecting at least two of the at least one body members.

15. The kit of parts (1) according to any of claims 1 to 14, wherein at least one of:the means (10) configured to cause a resistance positioned between at least two of the at least one body members (5) comprise an edge, optionally an edge extending perpendicular to the y-axis, wherein the edge is configured to cause a resistance against an implant (11) being inserted into the inner volume (4) along the y-axis,the means configured to cause a resistance are positioned in between a proximal half (15) and a distal half (16), or in the distal half of the body (3 ),the means configured to cause a resistance are formed by the at least one body member, in particular by an edge of the at least one body member configured to cause a resistance against an implant being inserted into the inner volume along the y-axis,or a combination thereof.

16. The kit of parts (1) according to any of claims 1 to 15, wherein the means (10) configured to cause a resistance are further configured to direct a flow of the liquified at least partial volume of the implant (11) upon transmission of ultrasound energy to the implant during or after insertion.

17. The kit of parts (1) according to any of claims 1 to 16, wherein the implant (11) is at least one of:configured to be at least partially liquified by ultrasound, and optionally wherein the kit of parts further comprises a sonotrode,a pin, an implant for tenodesis or a suture anchor, optionally wherein the kit further comprises a suture for use with the suture anchor,or a combination thereof.

18. The kit of parts (1) according to any of claims 1 to 17, wherein the implant (11) has a shape that is at least partially complementary to the shape of the inner volume (4).

19. The kit of parts (1) according to any of claims 1 to 18, wherein:the body (3 ) is made of four body members (5), optionally elongated body members, extending parallel to the y-axis, at least partially spaced apart to form at least four apertures (6), the body comprises means (10) configured to cause a resistance against the implant (11), wherein the means connect the four body members in a distal half (16) of the body, and the opening member (7) optionally connects the body members in the proximal section (24), optionally at the proximal end (8) of the body;orthe at least one body member forms a net - shaped body and the proximal section (24) of the body is optionally tapered along the y-axis in direction from the proximal end (8) to the distal end (9 ) of the body (3 ), in particular forms a collar.

20. The kit of parts (1) according to any of claims 1 to 19, wherein the device (2) further comprises means for creating a recess in a hard tissue, optionally at the distal end (9 ) ofthe body (3 ), optionally a punching tip, a drill, a thread, a reamer or a tap.

21. The kit of parts (1) according to any of claims 1 to 20, wherein at least one of:the device (2), or at least one of: the at least one body member (5), the opening member (7), the means (10) configured to cause a resistance against the implant (11), or a combination thereof, is / are made of titanium, steel, zinc, magnesium, alloys thereof, calcium phosphate ceramics, in particular hydroxyapatite, high-performance plastics, in particular polyether ether ketone (PEEK), polyetherketoneketone (PEKK), polyaryletherketone (PAEK), polysulfones (PSU) or polyphenylene sulfides (PPS),the distal end (9 ) of the body (3 ) comprises at least one, optionally two, openings for guiding through a suture, or a combination thereof.

22. The kit of parts (1) according to any of claims 1 to 21, wherein a surface of the at least one body member (5) and / or of the means (10) configured to cause a resistance, in particular a surface facing the inner volume (4), is polished or etched to a sub -pm roughness.

23. The kit of parts (1) according to any of claims 1 to 22, wherein the kit of parts further comprises a hardening material (21) for orthopedic use, optionally in powder or neat form.

24. The kit of parts (1) according to claim 23, wherein the kit of parts further comprises an instrument configured to administer the hardening material (21) into a recess (22) in a hard tissue (23 ).

25. A method for implanting a device (2) and an implant (11) having thermoplastic properties into a hard tissue (23 ), comprising the steps:(al) providing a hard tissue with a recess (22) suitable for inserting the device, or(a2) providing a hard tissue and creating, optionally drilling, a recess into the hard tissue suitable for inserting the device;(b) providing the device as defined in any of claims 1 to 24; (c) inserting the device into the recess in the hard tissue; (d) providing and inserting an implant having thermoplastic properties as defined in any of claims 1 to 18 through the opening into the device while or followed by transmitting ultrasound energy to the implant for a time sufficient to liquify the implant to the extent that a liquified at least partial volume of the implant extends out of the inner volume (4) of the device through at least one of the at least three apertures (6), optionally through each aperture.

26. The method according to claim 25, wherein the device (2) and implant (11) are provided as the kit of parts (1) according to any of claims 1 to 18.

27. The method according to claim 25 or 26, wherein at least one of the at least three, optionally each, aperture (6) is positioned to extend from a point of the body (3 ) located within a cortex of the hard tissue (23 ), or from a point of the body located at the interface between a cortex and a spongy bone of the hard tissue, when the device (2) is inserted into the recess (22) in the hard tissue.

28. The method according to any of claims 25 to 27, wherein the means (10) configured to cause a resistance against the implant (11) being inserted into the inner volume (4) along the y-axis are positioned in the spongy bone (20) when the device (2) is inserted into the recess (22) in the hard tissue (23 ).

29. The method according to any of claims 25 to 28, wherein the device (2) is implanted such that the proximal section (24) of the body (3 ), in particular the proximal end (8) of the body, and / or the opening member (7) sits flush with or raised with respect to a rim of the recess (22) in the hard tissue (23 ).

30. The method according to any of claims 25 to 29, wherein the device (2) is dimensioned such that a distance between the proximal end (8) and the distal end (9 ) of the body (3 ) corresponds at least to the thickness of a cortex in the hard tissue (23 ), or wherein the device is dimensioned such that the body extends through a cortex of the hard tissue into a spongy bone (20) of the hard tissue, when the device is inserted into the recess (22) in the hard tissue.

31. The method according to any of claims 25 to 30, wherein the device (2) is configured such thatthe liquified at least partial volume of the implant (11) extends out of the inner volume (4) of the device through at least one, optionally through each, of the at least three apertures (6), into a subcortical part of the hard tissue (23 ), in particular into a spongy bone (20); and / orat least three apertures, optionally at least three apertures with a minimum area of 0.2 to 0.5 mm2, are positioned in a subcortical part of the hard tissue, in particular in a spongy bone.

32. The method according to any of claims 25 to 31, whereinin step (al) or (a2), a hard tissue (23 ) is provided with a recess (22) that is at least partially filled with a hardening material (21) for orthopedic use;orthe method before step (c) further comprises step (bb) of providing a hardening material for orthopedic use and at least partially filling the recess with the hardening material;wherein the device (2) is inserted in step (c) into the hardening material and the implant (11) is inserted in step (d) into the device when the hardening material is in a nonhardened or partially hardened form, in particular in a partially hardened form with a viscosity between 10 Pas and 1000 Pas, optionally between 10 Pas and 200 Pas; orwherein the method further comprises the step of creating, optionally drilling, a recess into the hardened hardening material before or during step (c) and inserting the device into the recess in the hardened hardening material.

33. The method according to any of claims 25 to 32, wherein the recess (22) in the hard tissue (23 ) or in the hardened hardening material (21) is created, optionally by punching, screwing, drilling or tapping, by means of the device (2), wherein the device comprises means for creating the recess in the hard tissue or in the hardened hardening material, optionally at the distal end (9 ) of the body (3 ), optionally a punching tip, a drill, a thread, a reamer or a tap.

34. The method according to claim 25, wherein the recess (22) in the hardening material (21) is created by an instrument used for at least partially filling the recess in the hard tissue with the hardening material, optionally by a cannula, a screw or a reamer configured to administer the hardening material into the recess (22) in the hard tissue (23 ).

35. The method according to any of claims 25 to 34, wherein the proximal section (24) of the body and / or the opening member (7) comprise a thread facing an exterior of the device (2) and the thread is screwed into the hard tissue (23 ), optionally the cortex, when inserting the device into the recess (22) in the hard tissue.

36. The kit of parts (1) according to any of claims 1 to 24 or the method according to any of claims 25 to 35, wherein thehard tissue (23 ) is a human, animal or artificial hard tissue, optionally a cartilage - covered hard tissue, and optionally wherein the hard tissue 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.

37. The kit of parts according to any of claims 1 to 24 or 36, or the method according to any of claims 25 to 36, wherein the hard tissue (23 ) has a reduced bone density, optionally is an osteoporotic bone.

38. The method according to any of claims 25 to 37, wherein the method is for treatment of a shoulder or cruciate ligament injury.

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