Implant and kit for treating a bone defect

Abstract

An implant for treating a bone defect wherein the implant comprises osteoconductive supporting bodies and an insertion aid. The insertion aid is designed for insertion of the osteoconductive supporting bodies into a bone defect and for holding together the osteoconductive supporting bodies. Also disclosed is a kit comprised of an implant for treating a bone defect.

Claims

1. An implant for treating a bone defect, comprising: osteoconductive supporting bodies and an insertion aid, wherein the insertion aid is designed for insertion of the osteoconductive supporting bodies into a bone defect and for holding together the osteoconductive supporting bodies, the insertion aid is configured as a combination of a textile flat structure and a bonding agent, wherein the osteoconductive supporting bodies are bonded to one another by means of the bonding agent with formulation of a pastry or kneadable preparation, wherein the bonding agent comprises an amount of liquid diluent of 60 wt % to 90 wt %, based on the total weight of the bonding agent, further wherein the bonding agent is configured as an adhesive, wherein the adhesive comprises an oligopeptide having 2 to 100 amino acid units and a terminal oligolactam and/or a nitrogen-functionalized polysaccharide.

2. The implant of claim 1, wherein the osteoconductive supporting bodies comprise apatite and/or tricalcium phosphate or consist of apatite and/or tricalcium phosphate.

3. The implant of claim 2, wherein the apatite and/or the tricalcium phosphate has a porosity of 1% to 50%.

4. The implant of claim 2, wherein the apatite and/or the tricalcium phosphate is/are not configured to be porous.

5. The implant of claim 2, wherein the apatite is selected from the group consisting of hydroxyapatite, fluorapatite, chlorapatite, carbonate-fluorapatite and mixtures of at least two of thereof.

6. The implant of claim 2, wherein the tricalcium phosphate is selected from the group consisting of alpha-tricalcium phosphate, beta-tricalcium phosphate and a mixture of alpha-tricalcium phosphate and beta-tricalcium phosphate.

7. The implant of claim 1, wherein the textile flat structure is a mesh.

8. The implant of claim 1, wherein the bonding agent comprises a protein and/or a polysaccharide.

9. The implant of claim 1, wherein the bonding agent comprises glycerol.

10. The implant of claim 1, wherein the diluent is glycerol and/or water.

11. The implant of claim 1, wherein the bonding agent comprises carboxymethyl cellulose and glycerol.

12. The implant of claim 1, wherein the bonding agent is configured as an adhesive.

13. The implant of claim 8, wherein the protein is collagen and/or gelatin.

14. The implant of claim 8, wherein the polysaccharide is a cellulose derivative and/or hyaluronic acid.

15. The implant of claim 14, wherein the cellulose derivative is carboxymethyl cellulose.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1: a top view of a human acetabulum,

(2) FIG. 2: an embodiment of an implant according to the invention,

(3) FIG. 3: a further embodiment of an implant according to the invention,

(4) FIG. 4: a further embodiment of an implant according to the invention,

(5) FIG. 5: a further embodiment of an implant according to the invention,

(6) FIG. 6a-d: different embodiments of osteoconductive supporting bodies,

(7) FIG. 7: an embodiment of osteoconductive supporting bodies in combination with a thread-shaped pulling element,

(8) FIG. 8a-c: treatment of a defective acetabulum by means of an implant according to the invention,

(9) FIG. 9: an embodiment of an insertion aid,

(10) FIG. 10: a further embodiment of an implant according to the invention,

(11) FIG. 11: a further embodiment of an implant according to the invention,

(12) FIG. 12: a further embodiment of an implant according to the invention and

(13) FIG. 13: a further embodiment of an implant according to the invention.

(14) FIG. 1 is a schematic top view of a human acetabulum 1, also referred to as the hip joint socket or cotyloid cavity. It is the bony portion of the hip joint formed by the pelvis. The acetabulum is formed by fusion of portions of the ischium, the ilium, and the pubic bone. This fusion is completed at the age of about 6 months.

(15) Under ideal circumstances, the acetabulum and femoral head correspond to each other, i.e. the round femoral head fits precisely into the acetabulum, which embeds and encloses it over a wide area. The hip joint is a multiaxial ball-and-socket joint and is therefore more or less freely moveable in virtually any direction. This ensures high mobility and load-bearing capacity.

(16) The joint-forming parts of the hip joint are surrounded by a connective tissue capsule, whose inner lining, the synovium, continuously produces new synovial fluid. The edge of the bony socket is formed by a ring-shaped joint lip composed of cartilage.

(17) The acetabulum 1 has an anterior acetabular rim 2, also referred to as the anterior horn, and a posterior acetabular rim 4, also referred to as the posterior horn. The acetabular roof 3, which lies between these structures, has a round or an essentially round configuration.

(18) FIG. 2 is a schematic diagram of an embodiment of an implant according to the invention 100.

(19) The implant 100 comprises osteoconductive supporting bodies 110 and an insertion aid 130. The insertion aid 130 is configured as a sheath surrounding the osteoconductive supporting bodies 110.

(20) The osteoconductive supporting bodies 110 can for example as shown be in the form of tetrahedra. The tetrahedron-shaped configuration of the supporting bodies 110 facilitates compaction, in particular impaction, of the supporting bodies, allowing a three-dimensional structure to be created, which in particular can reflect the spongiosa of human or animal bone.

(21) The sheath 130 comprises two layers 131; 132 arranged one on top of the other that are connected to each other on their edge by means of a seam 135. The layers 131; 132 as shown can for example have a roughly disk-shaped configuration. The seam 135 can for example be composed of a non-in vivo degradable/non-in vivo resorbable suture material, such as e.g. a polypropylene thread, or an in vivo degradable/in vivo resorbable suture material, such as e.g. a polyglycolide thread.

(22) The two layers 131; 132 sewn to each other enclose a hollow space that is filled at least partially, in particular only partially, with the osteoconductive supporting bodies 110.

(23) The two layers 131; 132 are preferably composed of an in vivo degradable/in vivo resorbable material. The material can in particular be collagen, preferably collagen derived from bovine pericardium. This is advantageous in that it allows new bone tissue to grow into the implant and thus into the bone defect.

(24) The osteoconductive supporting bodies 110 function in a particularly advantageous manner as a guide structure for growing-in bone tissue.

(25) FIG. 3 is a schematic diagram of a further embodiment of an implant according to the invention 100.

(26) The implant 100 comprises osteoconductive supporting bodies 110, an osteoactive substance 120, such as e.g. collagen and/or fibrin, and an insertion aid 130. The insertion aid 130 is configured as a sheath surrounding the osteoconductive supporting bodies 110 and the osteoactive substance 120.

(27) With respect to further features and advantages of the implant 100, in particular the insertion aid or sheath 130, the explanation given for FIG. 2 is incorporated herein by reference in its entirety.

(28) FIG. 4 is a schematic diagram of a further embodiment of an implant according to the invention 100.

(29) The implant 100 comprises osteoconductive supporting bodies 110 and two insertion aids 130a and 130b, which are respectively configured as sheaths. Osteoconductive supporting bodies 110 are contained in the two sheaths 130a; 130b respectively.

(30) The implant further comprises an intermediate area 150 and a lateral area 160.

(31) The lateral area 160 can comprise a fastening device 165, for example in the form of a sleeve. The fastening device 165 is preferably configured to allow fastening of the implant 100 to bone tissue, which is preferably adjacent to a bone defect.

(32) The implant 100 can further comprise a seam 135 for forming the sheaths 130a; 130b and/or reinforcing a seam 135. The seam 135 is preferably configured to run continuously along edge areas of the implant 100 and/or the two sheaths 130a; 130b. The seam 135 can be formed by a shrinkable thread, such as e.g. a thread of poly-4-hydroxybutyrate. This makes it possible in a particularly advantageous manner, for example by radiation-induced shrinkage of the seam 135, to adapt the shape of the implant 100 to a patient-specific shape of a bone defect.

(33) Both the two sheaths 130a; 130b and the sections 150 and 160 respectively can comprise a mesh structure, in particular a knitted mesh structure, for example with monofilament polypropylene threads.

(34) With respect to further features and advantages of the implant 100 shown, the explanation given for FIG. 2 is incorporated herein by reference in its entirety.

(35) FIG. 5 is a schematic diagram of a further embodiment of an implant according to the invention 100.

(36) The implant 100 comprises a central area 140 and three insertion aids 130a; 130b; 130c configured as sheaths.

(37) The sheaths 130a; 130b; 130c are arranged radially around the central area 140.

(38) The respective sheaths 130a; 130b; 130c are filled at least partially, in particular only partially, with osteoconductive supporting bodies 110.

(39) The central area 140 is preferably configured to be applied to a floor area of a bone defect, while the sheaths 130a; 130b; 130c are preferably configured to be applied to side walls, in particular bone walls that radially surround a bony defect floor.

(40) Both the sheaths 130a; 130b; 130c and the central area 140 respectively comprise a seam 135 running along the edge. In this case as well, the seam 135 can be formed for example by a shrink thread, such as e.g. a thread of poly-4-hydroxybutyrate. By means of selective shrinkage of the seam 135, for example by irradiation, application of the sheaths 130a; 130b; 130c to bone walls radially surrounding the floor of the bone defect can be facilitated.

(41) The sheaths 130a; 130b; 130c and the central area 140 respectively can comprise two mesh layers, in particular knitted mesh layers, arranged on top of each other and connected to each other on the edge by the seam 135.

(42) In this manner, the sheaths 130a; 130b; 130c and the central area 140 define respective hollow spaces. At least the hollow spaces of the sheaths 130a; 130b; 130c can be filled at least partially, in particular only partially, with the osteoconductive supporting bodies 110.

(43) As a whole, the implant 100 is preferably configured in the manner of a triple-bladed propeller, wherein the central area 140 forms the “shaft” and the sheaths 130a; 130b; 130c the “blades” of the propeller.

(44) With respect to further features and advantages of the implant 100 shown in FIG. 5, the explanation given for FIG. 2 is incorporated herein by reference in its entirety.

(45) FIGS. 6a-d show one embodiment each of the osteoconductive supporting bodies 110, each of which facilitates compaction, in particular impaction, for example by means of an impactor.

(46) The supporting body 110 shown in FIG. 6a comprises oblong structural elements 112 extending in rectilinear fashion that are assembled to form a tetrahedron-shaped overall structure. The hollow space volume 114 produced by the mutual arrangement of the structural elements 112 contributes in a particularly advantageous manner toward increasing the absolute hollow space volume of a three-dimensional and osteoconductive structure that is obtainable by compaction, in particular impaction, of the osteoconductive supporting bodies. In this manner, for example, it is possible to simulate the spongiosa of human or animal bone, in particular with respect to porosity.

(47) Moreover, the embodiment shown in FIG. 6a facilitates engagement, in particular mutual clamping, of the osteoconductive supporting bodies on application of force and thus the production of a guide structure formed by the supporting bodies.

(48) The supporting body 110 shown in FIG. 6b is in the form of a tetrapod. A tetrapod-shaped configuration of the supporting bodies also facilitates engagement, in particular mutual clamping, of the osteoconductive supporting bodies on application of force and thus the production of a guide structure formed by the supporting bodies.

(49) The supporting body 110 shown in FIG. 6c is in the form of a tetrahedron. A tetrahedron-shaped configuration of the supporting bodies also facilitates engagement, in particular mutual wedging, of the osteoconductive supporting bodies on application of force and thus the production of a guide structure formed by the supporting bodies.

(50) The supporting body 110 shown in FIG. 6d is in the form of a pyramid. A pyramid-shaped configuration of the supporting bodies also facilitates engagement, in particular mutual wedging, of the osteoconductive supporting bodies on application of force and thus the production of a guide structure formed by the supporting bodies.

(51) FIG. 7 is a schematic diagram of osteoconductive supporting bodies 110 and an oblong pulling element 170 that can be used in the context of the present invention.

(52) The supporting bodies 110 have respective through openings 114 and can as shown for example have a cuboid configuration. The oblong pulling element 170, as shown, can be guided through the openings 114. In this way, compacting, in particular securing, of the supporting bodies 110 with formation of an osteoconductive guide structure can be achieved. The pulling element 170 is preferably a thread, for example of polypropylene or a polyhydroxyalkanoate, such as e.g. polylactide or polyglycolide.

(53) FIGS. 8a-c show a schematic diagram of treatment of a defective acetabulum by means of an implant according to the invention.

(54) FIG. 8a shows an acetabulum 10 with a defect 12 and surrounding bone tissue 14.

(55) The implant 100 comprises osteoconductive supporting bodies 110, an osteoactive substance 120 and an insertion aid 130. The insertion aid 130 is configured as a sheath surrounding the osteoconductive supporting bodies 110 and the osteoactive substance 120 (cf. FIG. 8b).

(56) The implant 100 is first placed in the defective acetabulum 10.

(57) After placement of the implant 100, the osteoconductive supporting bodies 110 are preferably converted to a compacted, in particular impacted, state. This can be carried out for example using a so-called impactor.

(58) An artificial joint socket 200 is then placed on the implant 100 or on bone cement optionally applied to the implant 100 in advance (cf. FIG. 8c).

(59) If the sheath 130 is in vivo degradable or in vivo resorbable and/or configured with open pores, the growth of bone tissue, in particular new bone tissue, into the implant 100 and therefore into the defective acetabulum 10, advantageously occurs within the first four weeks after surgery.

(60) The preferably compacted, in particular impacted, supporting bodies 110 of the implant 100 act as an osteoconductive guide structure for the growing in of bone tissue, while the osteoactive substance 120 enhances and/or stimulates the growing in of bone tissue in a particularly advantageous manner. In this way, the implant 100 can effectively increase the secondary stability of the implanted joint socket 200.

(61) With respect to further features and advantages of the implant 100, the explanation given for FIG. 2 is incorporated herein by reference in its entirety.

(62) FIG. 9 is a schematic diagram of an insertion aid 130 configured as a plate-shaped covering.

(63) The covering 130 comprises a concave surface 133 to which osteoconductive supporting bodies can be fixed or fastened.

(64) Moreover, the covering comprises 130 a concave connecting area 134. The connecting area 134 is configured to provide a connection to an artificial joint socket, in particular to a convex surface of an artificial socket.

(65) Moreover, the covering 130 comprises anchoring pins 136. The anchoring pins 136 can be driven into a bone, allowing the covering 130 to be anchored in the area of a bone defect to be treated.

(66) The covering 130 further comprises a fastening means opening 137. The opening 137 is configured to accommodate a fastening means, such as e.g. a locking screw. In this manner, an additional possibility for anchoring the covering 130 is provided.

(67) The purpose of both the anchoring pins 136 and the fastening means opening 137 is to achieve primary stability.

(68) FIG. 10 shows a schematic view of a further embodiment of an implant according to the invention 100.

(69) The implant 100 comprises osteoconductive supporting bodies 110 and an insertion aid configured as a combination of a mesh 130a and a plate-shaped covering 130b.

(70) The mesh 130a preferably fixes the osteoconductive supporting bodies 110 to a concave surface 133 of the covering 130b. For this purpose, the mesh 130a is preferably materially bonded to the surface 133. For example, the mesh 130a can be glued to the surface 133.

(71) Furthermore, the mesh 130a can be a knitted mesh, in particular a knitted polypropylene mesh.

(72) With respect to further features and advantages of the covering 130b, the explanation given in connection with FIG. 9 is incorporated herein by reference in its entirety. The explanations given therein with respect to the covering 130 also apply mutatis mutandis to the covering 130b shown in FIG. 10.

(73) FIG. 11 shows a further embodiment of an implant according to the invention 100.

(74) The implant 100 comprises osteoconductive supporting bodies 110 and an insertion aid configured as a combination of a bonding agent 130a and a plate-shaped covering 130b.

(75) The bonding agent 130a bonds, and preferably glues, the osteoconductive supporting bodies 110 to one another. At the same time, the bonding agent 130a preferably fixes the osteoconductive supporting bodies 110 to a concave surface 133 of the covering 130b.

(76) The bonding agent 130a preferably comprises a protein, in particular collagen and/or gelatin, and/or a polysaccharide, in particular a cellulose derivative and/or hyaluronic acid.

(77) With respect to further features and advantages of the covering 130b, the explanation given in connection with FIG. 9 is incorporated herein by reference in its entirety. The explanations given therein with respect to the covering 130 also apply mutatis mutandis to the covering 130b shown in FIG. 11.

(78) FIG. 12 shows a further embodiment of an implant according to the invention 100.

(79) The implant 100 comprises osteoconductive supporting bodies 110 and an insertion aid configured as a combination of a sheath 130a and a plate-shaped covering 130b.

(80) The sheath 130a preferably fixes the osteoconductive supporting bodies 110 to a concave surface 133 of the covering 130b. For this purpose, the sheath 130a is preferably connected to the surface 133 by material bonding. For example, the sheath 130a can be glued to the surface 133. For example, the bonding agent described in FIG. 11 can be used for this purpose.

(81) The sheath 130a can be configured in a mesh-shaped manner or be produced from an animal membrane, preferably pericardium.

(82) With respect to further features and advantages of the covering 130b, the explanation given in connection with FIG. 9 is incorporated herein by reference in its entirety. The explanations given therein with respect to the covering 130 also apply mutatis mutandis to the covering 130b shown in FIG. 12.

(83) FIG. 13 is a schematic diagram of a further embodiment of an implant according to the invention 100.

(84) The implant 100 comprises osteoconductive supporting bodies 110 and an insertion aid 130 configured as a bonding agent.

(85) The bonding agent 130 bonds, and preferably glues, the osteoconductive supporting bodies 110 to one another.

(86) In a particularly advantageous manner, the implant 100 shown can easily be adapted during surgery to a bone defect to be treated with respect to shape and quantity.

(87) With respect to further features and advantages of the implants shown in the figures, the general description is incorporated herein by reference in its entirety.