Surgical implant
10245152 ยท 2019-04-02
Assignee
Inventors
Cpc classification
A61F2310/00023
HUMAN NECESSITIES
A61F2310/00017
HUMAN NECESSITIES
A61F2002/30677
HUMAN NECESSITIES
A61F2002/2817
HUMAN NECESSITIES
A61F2002/30062
HUMAN NECESSITIES
A61F2002/30583
HUMAN NECESSITIES
A61F2002/30617
HUMAN NECESSITIES
A61F2002/3092
HUMAN NECESSITIES
A61F2310/00029
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2/4465
HUMAN NECESSITIES
A61F2310/00239
HUMAN NECESSITIES
International classification
Abstract
The present invention is directed to a surgical implant for the fusion of two adjacent vertebrae with an upper plane for contacting an upper vertebral body and a lower plane for contacting a lower vertebral body and a tubular structure, wherein the tubular structure is formed by a plurality of tubes running from the upper plane to the lower plane and in substantially horizontal direction throughout one side of the surgical implant straight to the opposite side of the surgical implant. This tubular structure has the advantage that the formation and ingrowth of new bone is promoted and advantaged and that the degree of formation and ingrowth of new bone is detectable by X-ray measurements.
Claims
1. A radiopaque intervertebral metal implant for fusion of two bridged vertebral bodies comprising: an upper plane for contacting an upper vertebral body; a lower plane for contacting a lower vertebral body; a tubular structure formed by a plurality of tubes for the fusion of the two bridged vertebral bodies, the plurality of tubes comprises vertical tubes and horizontal tubes, wherein the vertical tubes run from the upper plane to the lower plane and the horizontal tubes run in a substantially horizontal direction throughout one side of the intervertebral implant straight to the opposite side of the intervertebral implant thereby interconnecting the vertical tubes; the horizontal tubes of the tubular structure are parallel to each other or are grouped into groups of parallel horizontal tubes so that X-ray spectra or radiographs are conductable through the horizontal tubes, and wherein all surfaces of the intervertebral metal implant have a roughness of 6.0 Ra to 8.5 Ra.
2. The radiopaque intervertebral metal implant according to claim 1, further comprising at least one cavity in the center of the implant extending from the upper plane to the lower plane, and a boundary layer surrounding the at least one cavity.
3. The radiopaque intervertebral metal implant according to claim 2, wherein the boundary layer has a thickness of 1.5 mm to 10.0 mm.
4. The radiopaque intervertebral metal implant according to claim 2, wherein the at least one cavity is filled with a bone replacement material selected from polymeric bioresorbable materials, polymeric bioresorbable materials containing an osteoinductive agent, bioresorbable materials containing bone-forming cells or materials which are converted to new bone under physiologic conditions.
5. The radiopaque intervertebral metal implant according to claim 1, further comprising two, three, four, five or six cavities.
6. The radiopaque intervertebral metal implant according to claim 5, wherein between 10% and 90% of the horizontal tubes terminate at one of the cavities.
7. The radiopaque intervertebral metal implant according to claim 1, wherein the intervertebral implant has a porosity of at least 75%.
8. The radiopaque intervertebral metal implant according to claim 1, wherein a ratio of a volume of a solid implant material to a total implant surface area is between 200 m and 230 m.
9. The radiopaque intervertebral metal implant according to claim 1, wherein the vertical tubes of the tubular structure extend substantially along a longitudinal axis of a spinal column.
10. The radiopaque intervertebral metal implant according to claim 1, wherein the tubes have a dimension of 250 m to 2,000 m.
11. The radiopaque intervertebral metal implant according to claim 1, wherein the upper plane and the lower plane of the implant have at least 80 tubes per cm.sup.2.
12. The radiopaque intervertebral metal implant according to claim 1, wherein the vertical tubes and/or the horizontal tubes don't change their inner diameter on their way through the implant.
13. The radiopaque intervertebral metal implant according to claim 1, wherein the implant is manufactured in one continuous piece.
14. The radiopaque intervertebral metal implant according to claim 1, wherein the implant is selected from the group consisting of cervical cages, thoracic cages, lumbar cages, artificial intervertebral disks and implants for the fusion of natural and artificial vertebrae.
15. The radiopaque intervertebral metal implant according to claim 1, wherein a ratio of a volume of a material of the implant to a volume of the tubes ranges from 10 vol. %:90 vol. % to 20 vol. %:80 vol. %.
16. The radiopaque intervertebral metal implant according to claim 1, wherein the metal implant is a titanium implant.
17. A radiopaque intervertebral metal implant for fusion of two bridged vertebral bodies comprises: an upper plane for contacting an upper vertebral body; a lower plane for contacting a lower vertebral body; at least one cavity in the center of the implant extending from the upper plane to the lower plane, wherein the at least one cavity is surrounded by a boundary layer with a tubular structure comprising vertical tubes and horizontal tubes; wherein the vertical tubes run from the upper plane to the lower plane; and the horizontal tubes run in a substantially horizontal direction throughout one side of the intervertebral implant straight to the opposite side of the intervertebral implant thereby interconnecting the vertical tubes, the horizontal tubes are parallel to each other or are grouped into groups of parallel horizontal tubes so that X-ray spectra or radiographs are conductable through the horizontal tubes, and wherein all surfaces of the intervertebral metal implant have a roughness of 6.0 Ra to 8.5 Ra.
18. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer surrounds the at least one cavity completely on the upper plane and the lower plane.
19. The radiopaque intervertebral metal implant according to claim 17, wherein the at least one cavity comprises two, three, four, five or six cavities.
20. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer has a thickness of 1.5 mm to 10.0 mm.
21. The radiopaque intervertebral metal implant according to claim 17, wherein the intervertebral implant has a porosity of at least 75%.
22. The radiopaque intervertebral metal implant according to claim 17, wherein a ratio of a volume of a solid implant material to a total implant surface area is between 200 m and 230 m.
23. The radiopaque intervertebral metal implant according to claim 17, wherein the vertical tubes of the tubular structure extend substantially along a longitudinal axis of a spinal column.
24. The radiopaque intervertebral metal implant according to claim 17, wherein between 10% and 90% of the horizontal tubes terminate at the at least one cavity.
25. The radiopaque intervertebral metal implant according to claim 17, wherein the at least one cavity is filled with a bone replacement material selected from polymeric bioresorbable materials, polymeric bioresorbable materials containing an osteoinductive agent, bioresorbable materials containing bone-forming cells or materials which are converted to new bone under physiologic conditions.
26. The radiopaque intervertebral metal implant according to claim 17, wherein the tubes have a dimension of 250 m to 2,000 m.
27. The radiopaque intervertebral metal implant according to claim 17, wherein the upper plane and the lower plane of the implant have at least 80 tubes per cm.sup.2.
28. The radiopaque intervertebral metal implant according to claim 17, wherein the vertical tubes and/or the horizontal tubes don't change their inner diameter on their way through the implant.
29. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer is manufactured in one continuous piece.
30. The radiopaque intervertebral metal implant according to claim 17, wherein the implant is selected from the group consisting of cervical cages, thoracic cages, lumbar cages, artificial intervertebral disks and implants for the fusion of natural and artificial vertebrae.
31. The radiopaque intervertebral metal implant according to claim 17, wherein the implant has a ratio of a volume of a material of the implant to a volume of the tubes ranges from 10 vol. %:90 vol. % to 20 vol. %:80 vol. %.
32. The radiopaque intervertebral metal implant according to claim 17, wherein a ratio of a volume of the at least one cavity to an overall volume of the implant within the boundary layer ranges from 1:2 to 1:1.
33. The radiopaque intervertebral metal implant according to claim 17, wherein the metal implant is a titanium implant.
Description
DESCRIPTION OF THE FIGURES
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EXAMPLES
(17) The following examples are included to demonstrate preferred embodiments of the invention. It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventor to function well in the practice of the invention, and thus can be considered to constitute preferred modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.
(18) Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as examples of embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.
Example 1: Cage
(19) Example 1 relates to a PEEK cage, especially a cervical cage with a longitudinal diameter of 14 mm and a transverse diameter of 12 mm and a height of 8 mm. The Cage is nearly oval and the longitudinal diameter is understood to be the maximum diameter and the transverse diameter is understood to be the smallest diameter.
(20) The cage is made of PEEK with an at least 1.1 mm thick boundary layer and an upper and lower flat plane for contact with the respective vertebral bodies. The boundary layer surrounds the anterior and the posterior side of the implant while the lateral sides do only have an upper and lower frame or ring of the boundary layer. In the middle of the lateral sides the inner tubular structure starts. At the posterior side of the implant a centrally round recess is located, which serves to hold an implantation tool during implantation and through which the cavity is filled with artificial bone material (PMMA).
(21) Inside the cage a honeycomb structure of tubes is formed with hexagonal walls. The vertical tubes extend in a straight line from the top of the bone-contacting surface to the opposite lower vertebral contacting flat surface. In the middle of the implant is a circular cavity completely filled with bone cement. Per cm.sup.2 bone-contacting surface about 34-42 tubes are available.
(22) The vertical tubes have a diameter of 870-970 m specified as the distance between two opposing parallel walls.
(23) The vertical tubes are also interconnected through openings in the tube walls.
(24) The openings have a wedge-shaped structure so that the tube walls can be shifted laterally only by the thickness of the notches against each other, which leads to an increased stability of the implant. The opening has a diameter of 60 m.
(25) The cage has also horizontal tubes perpendicular to the vertical tubes. The horizontal tubes are also formed with hexagonal walls and have the same diameter as the vertical tubes. The horizontal tubes run straight from one lateral side of the implant to the opposite side. The horizontal tubes are not connected with openings to each other. The margin area from where no horizontal tubes start is 1.5 cm wide and forms a square frame around the area where the horizontal tubes start.
Example 2: Cage
(26) Example 2 refers to a cage, especially a cervical cage with a longitudinal diameter of 14 mm and a transverse diameter of 12 mm and a height of 8 mm. The Cage is nearly oval and the longitudinal diameter is understood to be the maximum diameter and the transverse diameter is understood to be the smallest diameter.
(27) The cage is made of titanium and has a thickness of the boundary layer of 5 mm for contacting the respective vertebral body.
(28) Inside the boundary layer (1) there is a tubular structure of round tubes. The horizontal tubes (7) have all a diameter of 1.5 mm. The horizontal tubes (7) that don't run through the inner cavity are straight and in parallel so that x-ray beams can pass along these tubes (7). There are two groups of vertical tubes. The boundary layer (1) is traversed from its upper plane (3A) up to its lower plane (3B) with round vertical tubes (5) having a larger diameter of 1.0 mm. In the periphery of the boundary layer (1) close to the inner surface (9) or close to the outer surface (8), there are smaller round vertical tubes (5) with a diameter of 0.5 mm that are placed between the outer surface (8) and the larger tubes (5) and also between the inner surface (9) and the larger tubes (5).
(29) Per cm.sup.2 upper plane (3A) of the boundary layer (1) as well as per cm.sup.2 lower plane (3B) of the boundary layer (1) there are between 30 and 100 vertical tubes (5). Per cm.sup.2 outer surface (8) of the boundary layer (1) as well as per cm.sup.2 inner surface (9) of the boundary layer (1) there are between 34 and 42 horizontal tubes (7). In the periphery of the boundary layer (1) there extend between 10 and 20 horizontal tubes (7) that run exclusively inside the boundary layer (1) and don't cross the inner cavity (2) or don't end on the inner surface (9) of the boundary layer (1).
(30) At the thinnest site between the horizontal tubes (7) the wall thickness amounts still to 0.2 mm. At the thinnest site between the vertical tubes (5) the wall thickness amounts still to 0.15 mm.
(31) The volume of the cage material (such as titanium) is 708 mm.sup.3 and the total surface area is 3198 mm.sup.2 so that the ratio of volume of cage material to total surface area is 221 m.
Example 3: TLIF Cage
(32) An embodiment of the inventive surgical implant is now described in regard of
(33) The horizontal tubes (7) have a hexagonal shape and a diameter of 2.0 mm in their full size, i.e. if the horizontal hexagonal tubes (7) are not cut off in the periphery of the boundary layer (1). Of all horizontal tubes 96% have this full size, i.e. they aren't cut off in the periphery of the boundary layer (1) and have said diameter. Per cm.sup.2 outer surface (8) and inner surface (9) the boundary layer (1) has between 5 and 15 horizontal tubes. The wall thickness (10) of the horizontal tubes amounts to 0.5 mm.
(34) The volume of the cage material (such as medical stainless steel) is 406 mm.sup.3 and the total surface area is 1958 mm.sup.2 so that the ratio of volume of cage material to total surface area is 207 m.
Example 4: ALIF Cage
(35) An embodiment of the inventive surgical implant is now described in regard of
(36) The horizontal tubes (7) have a hexagonal shape and a diameter of 2.0 mm in their full size, i.e. if the horizontal hexagonal tubes (7) are not cut off in the periphery of the boundary layer (1). Of all horizontal tubes 96% have this full size, i.e. they aren't cut off in the periphery of the boundary layer (1) and have said diameter. Per cm.sup.2 outer surface (8) and inner surface (9) the boundary layer (1) has between 2 and 20 horizontal tubes. The wall thickness (10) of the horizontal tubes amounts to 0.4 mm.
(37) The volume of the cage material (such as titanium) is 507 mm.sup.3 and the total surface area is 2371 mm.sup.2 so that the ratio of volume of cage material to total surface area is 214 m.
Example 5: Cage
(38) An embodiment of the inventive surgical implant is now described in regard of
(39) The vertical tubes (5) run from the upper plane (3A) of the implant straight and in parallel throughout the implant to the lower plane (3B) of the implant. The vertical tubes (5) have a hexagonal shape and a diameter of 1.0 mm in their full size, i.e. if they are not cut off in the periphery of the implant. The implant has in total 104 vertical tubes (5), while 25 vertical tubes do not have their full size, because they are cut off in the periphery of the implant and 79 vertical tubes do have their full size. Thus of all vertical tubes (5) 76% have the full size, i.e. they aren't cut off in the periphery of the implant. The wall thickness (6) of the vertical tubes (5) amounts to 0.3 mm. Moreover in one line from dorsal to ventral the vertical tubes are connected to each other by longitudinal cuts which have a breadth of 0.25 mm. Due to the longitudinal cuts in the walls of the vertical tubes (5) zig-zag walls extending from the ventral side of the implant to the dorsal side are formed which can perform micro movements in order to stimulate bone formation.
(40) Moreover the implant comprises 20 horizontal tubes (7) arranged in two lines of 10 horizontal tubes (7) one line upon the other running straight through the implant from one lateral side to the opposite lateral side of the implant so that X-ray beams can pass through these horizontal tubes (7) thereby passing through the implant. Also these horizontal tubes (7) have a hexagonal shape and all of them have a diameter of 1.0 mm in their full size, i.e. none of the horizontal hexagonal tubes (7) is cut off in the periphery of the implant. The wall thickness (10) of the horizontal tubes amounts to 0.3 mm. The horizontal tubes (7) are not interconnected to each other by longitudinal cuts or any other cuts into the walls of the horizontal tubes (7). However these horizontal tubes (7) run through or cross the vertical tubes (5).
(41) The volume of the cage material (such as titanium) is 607 mm.sup.3 and the total surface area is 2785 mm.sup.2 so that the ratio of volume of cage material to total surface area is 218 m.