AUGMENTATION DEVICE, COMPOSITE AND METHOD FOR PRODUCING A COMPOSITE

20230190479 · 2023-06-22

    Inventors

    Cpc classification

    International classification

    Abstract

    Augmentation material having a wire and, in axial alignment along the wire, a plurality of groups of axially adjacent connecting elements that extend radially from the wire, wherein the connecting elements are designed such that, when a first group from the plurality of groups is pressed together with a further group from the plurality of groups, the connecting element of the two groups can be connected to one another in a positive-locking and/or friction-locking manner.

    Claims

    1. An augmentation material comprising a wire and, in axial alignment along a longitudinal axis of the wire, a plurality of groups of axially adjacent connecting elements that extend radially from the wire, wherein the connecting elements are designed such that, when a first group from the plurality of groups is pressed together with a further group from the plurality of groups, the connecting elements of the two groups can be connected to one another in a positive-locking and/or friction-locking manner.

    2. The augmentation material according to claim 1, wherein axially adjacent connecting elements in a group have an axial connecting element spacing from one another which corresponds to at least one axial connecting element extension of a connecting element along the longitudinal axis of the wire.

    3. The augmentation material according to claim 1, wherein the connecting elements are formed as disks that extend radially from the wire.

    4. The augmentation material according to claim 3, wherein the disks are perforated and/or have an open-pore structure.

    5. The augmentation material according to claim 1, wherein the connecting elements are formed as pins that extend radially from the wire.

    6. The augmentation material according to claim 5, wherein a plurality of pins, in particular 4 to 10, extend radially adjacently from the wire.

    7. The augmentation material according to claim 5, wherein the pins extend radially from the wire with a pin length that corresponds to at least three times a wire diameter of the wire.

    8. The augmentation material according to claim 5, wherein the pins comprise mushrooms, hooks, loops, undercuts and/or latching elements; preferably the pins are formed as mushrooms, hooks, loops, undercuts and/or latching elements.

    9. The augmentation material according to claim 1, wherein a group of connecting elements comprises 3 to 20 axially adjacent connecting elements.

    10. The augmentation material according to claim 1, wherein axially adjacent groups of connecting elements have an axial group spacing (360) from one another which corresponds to at least twice the axial extension of a connecting element along the longitudinal axis of the wire.

    11. The augmentation material according to claim 1, wherein the augmentation material is produced using a generative 3D printing method.

    12. A composite comprising an augmentation material according to claim 1 and a bone cement, in particular a PMMA bone cement, wherein the augmentation material is encased in the bone cement.

    13. The composite according to claim 12, wherein the augmentation material in the composite occupies a volume fraction in the range of 30-70 percent by volume relative to the volume of the composite.

    14. A method for producing a composite according to claim 12 for filling a cavity, comprising the steps of a. providing the augmentation material in an arrangement substantially corresponding to the shape of the cavity; b. applying a bone cement paste in interspaces of the augmentation material such that the augmentation material is completely encased in the bone cement paste; and c. curing the bone cement paste to form the composite.

    15. The method according to claim 14, wherein the augmentation material is provided in the cavity to be filled, and the application of the bone cement paste into the interspaces of the augmentation material and the curing of the bone cement paste takes place in the cavity.

    Description

    FIGURES

    [0104] The invention is illustrated further in the following by way of example using figures. The invention is not limited to the figures.

    [0105] In the figures:

    [0106] FIG. 1 is a schematic top view of a portion of an augmentation material having a plurality of groups of connecting elements,

    [0107] FIG. 2 shows the augmentation material from FIG. 1 in a perspective side view,

    [0108] FIG. 3 is a further schematic top view of the augmentation material from FIGS. 1 and 2 with connected groups of connecting elements,

    [0109] FIG. 4 shows a further embodiment of an augmentation material in a schematic top view,

    [0110] FIG. 5 shows the augmentation material from FIG. 4 in a perspective side view,

    [0111] FIG. 6 shows a further embodiment of an augmentation material in a schematic top view,

    [0112] FIG. 7 shows the augmentation material from FIG. 6 in a perspective side view,

    [0113] FIG. 8 is a further schematic top view of the augmentation material from FIGS. 6 and 7 with connected groups of connecting elements,

    [0114] FIG. 9 shows a further embodiment of an augmentation material in a perspective side view,

    [0115] FIG. 10 shows a further embodiment of an augmentation material in a perspective side view,

    [0116] FIG. 11 shows a further embodiment of an augmentation material in a perspective side view, and

    [0117] FIG. 12 is a flowchart of a method for producing a composite.

    DESCRIPTION OF THE FIGURES

    [0118] FIG. 1 is a schematic top view of a portion of an augmentation material 100. The augmentation material 100 comprises a wire 200 and, along the longitudinal axis of the wire 200, a plurality of groups 350 of axially adjacent connecting elements 300 (provided only by way of example with a reference sign) that extend radially from the wire 200, wherein only five of the groups 350 are shown in FIG. 1. Each of the groups 350 comprises four axially adjacent connecting elements 300 in the form of round, discus-like shaped disks which are arranged concentrically around the wire 200. The wire 200 and the connecting elements 300 are formed in one piece. Within a group 350, the axially adjacent connecting elements 300 have an axial connecting element spacing 310 (provided only by way of example with a reference sign) which corresponds approximately to one and a half times an axial connecting element extension 320 (provided only by way of example with a reference sign). The connecting element spacing 310 corresponds to the spacing between two axially adjacent connecting elements 300 of a group 350 at the level of the wire 200 and thus the distance of the wire 200 between these connecting elements 300. The axial connecting element extension 320 corresponds to the axial extension of the connecting elements 300 on the end of the connecting elements 300 radially facing away from the wire 200.

    [0119] The individual groups 350 have an axial group spacing 360 (provided only by way of example with a reference sign) from one another which is three times the connecting element spacing 310. The axial group spacing 360 corresponds, analogously to the axial connecting element spacing 310, to the spacing between two axially adjacent groups 350 at the level of the wire and thus the distance of the wire 200 between these groups 350. The axial group spacing 360 enables a high flexibility of the augmentation device 100 and allows the shaping of a porous body made of the augmentation material 100.

    [0120] FIG. 2 shows the portion of the augmentation material 100 from FIG. 1 in a perspective side view.

    [0121] FIG. 3 is a further schematic top view of a portion of the augmentation material 100 from FIGS. 1 and 2, wherein the augmentation material 100 is shaped in such a way, in particular by deforming the wire 200, that a first group 350a of connecting elements 300a is connected in a positive-locking and friction-locking manner to a second group 350b of connecting elements 300b of the augmentation material 100.

    [0122] Matching the connecting element spacing 310 (cf. FIG. 1) to the connecting element extension 320 (cf. FIG. 1) allows a positive-locking connection of the connecting elements 300a, 300b of the two groups 350a, 350b.

    [0123] Connecting the two shown groups 350a, 350b as well as further groups (not shown) enables the formation of a porous body using the augmentation material 100. This porous body formed in this way from the augmentation material 100 can be used for filling cavities, in particular bone canals, and for forming a composite from the augmentation material 100 and a bone cement, in particular a PMMA bone cement.

    [0124] FIG. 4 is a schematic top view of a portion of a further embodiment of an augmentation material 100′. The embodiment of the augmentation material 100′ largely corresponds to the embodiment described above and shown in FIGS. 1 to 3, and therefore reference is made to the above description to avoid repetition. Modifications of an embodiment shown in FIGS. 1 to 3 have the same reference sign with an additional apostrophe.

    [0125] The axial group spacing 360′ (provided only by way of example with a reference sign) of the groups 350′ (provided only by way of example with a reference sign) of connecting elements 300′ (provided only by way of example with a reference sign) of the augmentation material 100′ corresponds to the axial connecting element spacing 310′ (provided only by way of example with a reference sign) of connecting elements 300′ within a group 350′, so that the groups 350′ appear to be a single large group of connecting elements 300′.

    [0126] FIG. 5 shows the augmentation material 100′ from FIG. 4 in a perspective side view.

    [0127] FIG. 6 is a schematic top view of a portion of a further embodiment of an augmentation material 100″. The embodiment of the augmentation material 100″ largely corresponds to the embodiments described above and shown in FIGS. 1 to 5, and therefore reference is made to the above description to avoid repetition. Modifications of any of the embodiments shown in FIGS. 1 to 5 have the same reference sign with two apostrophes.

    [0128] Compared with the embodiment of the augmentation material 100′ according to FIGS. 4 and 5, the embodiment shown in FIG. 6 has a smaller axial connecting element extension 320″ (provided only by way of example with a reference sign) of the individual connecting elements 320″.

    [0129] FIG. 7 shows the augmentation material 100″ from FIG. 6 in a perspective side view.

    [0130] FIG. 8 is a further schematic top view of a portion of the augmentation material 100″ from FIGS. 6 and 7, wherein the augmentation material 100″ is shaped in such a way, in particular by deforming the wire 200″, that a first group 350a″ of connecting elements 300a″ engages in a second group 350b″ of connecting elements 300b″ of the augmentation material 100″ in order to connect the groups 350a″, 350b″ to one another in a friction-locking manner when the groups 350a″, 350b″ are displaced along the longitudinal axis of the wire 200″. Because the axial connecting element extension 320″ is small compared with the axial connecting element spacing 310″, the groups 350a″, 350b″ do not form a positive-locking connection or only partially form one.

    [0131] FIG. 9 is a top view of a portion of a further embodiment of an augmentation material 100′″. The embodiment of the augmentation material 100′″ largely corresponds to the embodiments described above and shown in FIGS. 1 to 8, and therefore reference is made to the above description to avoid repetition. Modifications of any of the embodiments shown in FIGS. 1 to 8 have the same reference sign with three apostrophes.

    [0132] The connecting elements 300′″ (provided only by way of example with a reference sign) of the embodiment according to FIG. 9 are shaped in the form of pins and not, as in the above embodiments according to FIGS. 1 to 8, in the form of disks. Each of the axially adjacent groups 350′″ (provided only by way of example with a reference sign) of connecting elements 300′″ in the form of pins comprises five axially adjacent pins, wherein each of these pins comprises an additional seven radially adjacent pins. Each of the groups 350′″ thus comprises 40 connecting elements 300′″ in the form of pins. A group 350′″ thus comprises five subgroups of eight radially adjacent connecting elements 300′″ in the form of pins, wherein the subgroups of eight radially adjacent pins extend radially from the wire 200′″ in a cross-sectional plane of the wire 200″. In order to be able to effectively connect the connecting elements 300′″ in the form of pins of two groups 350′″ to one another in a friction-locking manner, the pins have a pin length 330 which corresponds to three times a wire diameter 210 of the wire 200′″. The individual groups 350″ are spaced apart from one another analogously to the augmentation material 100 of FIGS. 1 to 3.

    [0133] FIG. 10 is a perspective side view of another embodiment of an augmentation material 10″″. The embodiment of the augmentation material 100″″ largely corresponds to the embodiments described above and shown in FIGS. 1 to 9, and therefore reference is made to the above description to avoid repetition. Modifications of any of the embodiments shown in FIGS. 1 to 9 have the same reference sign with four apostrophes. The connecting elements 300′″ (provided only by way of example with a reference sign) of the embodiment according to FIG. 10 are shaped in the form of pins, similar to the connecting elements according to the embodiment according to FIG. 9. The connecting elements 300″″ in the form of pins each comprise a mushroom 340 on an end opposite the wire. When two groups 350″″ of connecting elements 300″″ are pressed together, the mushrooms 340 snap together, so that the augmentation material 100″″ can form a very stable porous body.

    [0134] FIG. 11 is a perspective side view of another embodiment of an augmentation material 10′″″. The embodiment of the augmentation material 100′″″ largely corresponds to the embodiments described above and shown in FIGS. 1 to 10, and therefore reference is made to the above description to avoid repetition. Modifications of any of the embodiments shown in FIGS. 1 to 10 have the same reference sign with five apostrophes. The connecting elements 300′″″ are designed as wedge-shaped disks, so that a good friction-locking connection of the groups 350′″″ is made possible when they are pressed together.

    [0135] FIG. 12 is a flowchart of a method 400 for producing a composite comprising the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ and a bone cement having the steps 410 to 430. The composite serves to fill a cavity.

    [0136] In step 410, the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ is provided in the form of a porous body which substantially corresponds to the shape of the cavity. For this purpose, the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ can be shortened, for example by means of shears or pliers, so that the shape of the cavity can be reproduced as closely as possible. In order to form the shape of the cavity, it is preferred that two or more of the groups 350, 350′, 350″, 350′″, 350″″, 350′″″ of connecting elements 300, 300′, 300″, 300′″, 300″″, 300′″″ are pressed together such that they interact in a positive-locking and/or friction-locking manner and thus structurally stabilize the porous body made of augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″.

    [0137] In step 420, a bone cement paste is applied into interspaces of the porous body shaped and provided from the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ such that the interspaces are filled with bone cement paste and the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ is encased in the bone cement paste.

    [0138] In step 430, the bone cement paste encasing the porous body made of augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ cures to form the composite. The bone cement paste transitions into bone cement.

    [0139] The composite produced in this way is inserted into the cavity to be filled, in particular a bone canal.

    [0140] In one embodiment of the method 400, the provision 410 of the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ takes place in the cavity to be filled, in particular a bone canal. The bone cement paste is applied in step 420 to the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ in the form of a porous body such that the interspaces are filled with bone cement paste and the augmentation material 100, 100′, 100″, 100′″, 100″″, 100′″″ is encased in the bone cement paste. The curing 430 of the bone cement paste to form the composite likewise takes place in the cavity to be filled.

    TABLE-US-00001 REFERENCE SIGNS 100, 100′, 1000″ Augmentation material 100″′, 100″″, 100″″′ 200, 200′, 200″ Wire 200″′, 200″″, 200″″′ 210 Wire diameter 300, 300′, 300″ Connecting element 300″′, 300″″, 300″″′ 300a Connecting elements first group 300b Connecting elements further group 310, 310′, 310″ Axial connecting element spacing 320, 320′, 320″ Axial connecting element extension 330 Pin length 340 Mushroom 350, 350′, 350″ Group of connecting elements 350″′, 350″″, 350″″′ 350a, 350a″ First group of connecting elements 350b, 350b″ Further group of connecting elements 360, 360′, 360″ Axial group spacing 400 Method for producing a composite 410 Provision 420 Application 430 Curing