INTERSOMATIC CAGE FOR VERTEBRAL STABILIZATION
Patent Information
- Application Number
- DE602021038640
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-06-18
- Filing Date
- 2021-06-16
- Publication Date
- 2025-09-17
- Estimated Expiration
- 2041-06-16
AI Technical Summary
Existing intersomatic cages cause inflammation, infection, and insufficient bone regrowth due to invasive surgical techniques and lack of effective integration with the vertebrae, and existing cages with medical substance receptacles do not adequately control release rates.
A hollow, prismatic intersomatic cage with biocompatible material containing surface receptacles for slow-release anti-inflammatory, anti-infection, and bone regrowth promoter drugs, such as BMP-2 and BMP-7, is designed with grooved gratings on inner and outer surfaces for stable drug delivery.
The cage minimizes clinical complications by promoting bone integration and reducing inflammation and infection through controlled drug release, enhancing vertebral stabilization and fusion.
Description
Field of the invention
[0001] The present invention relates to an intersomatic cage for vertebral stabilization designed to be inserted between two contiguous vertebrae so as to space them apart and thus keep them at a mutual distance such to restore the intervertebral space, creating the decompression of the nerve roots and the acceleration of the intersomatic fusion.State of the prior art
[0002] Intersomatic cages thus made comprise a generally prismatic-shaped body provided with a nose protruding from the front end of the body and designed to be inserted between two contiguous vertebrae during the surgical insertion of the intersomatic cage.
[0003] Distinctive examples of intersomatic cages for vertebral stabilization are described and illustrated, for example, in Italian patent applications n° 102019000023913 and n° 102020000001210 on behalf of the Applicant in question, not published at the filing or priority date of the present application.
[0004] These cages are applied using invasive surgical techniques which typically provide for - following insertion of the nose between the two vertebrae - rotations alternately in the direction of the cage and in the opposite direction, performed by means of a suitable manual instrument, while it is pushed so as to be wedged between the vertebrae.
[0005] Following the application, the intervertebral region is normally subject to inflammations and also to infections in some cases. Bone regrowth may also be insufficient and unsuitable to effectively incorporate the cage over time.
[0006] Documents EP 3459502A1, WO2012 / 010327A1 and US2011 / 282392A1 disclose intersomatic cages of the type defined above provided with receptacles containing slow release medical substances.Summary of the invention
[0007] The object of the present invention is to solve the aforementioned problems and in particular to provide an intersomatic cage of the type generally known from EP 3459502A1 which allows to limit if not even eliminate the negative clinical consequences for patients following the application thereof.
[0008] According to the invention, this object is achieved by the features set forth in claim 1.
[0009] Preferably the body is hollow and said surface receptacles are provided for on the inner and outer surfaces of said side walls of the body.Brief description of the drawings
[0010] The invention will now be described in detail with reference to the attached drawings, provided purely by way of non-limiting example, wherein: figure 1 is a front perspective view of the intersomatic cage according to the invention, figure 2 is a dorsal perspective view of the cage, figure 3 is a top plan view of the cage, figure 4 is a side elevational view of the cage, figure 5 is a front elevational view of figure 4, and figure 6 is a dorsal elevational view of figure 4. Detailed description of the invention
[0011] With reference to the figures, the intersomatic cage according to the invention consists of a generally prismatic-shaped and more precisely parallelepiped-shaped monolithic body 1, having an upper face 2 and a lower face 3 (with reference to the implanted position of the cage in the intervertebral space of a subject with an upright spine), and side faces 4, 5.
[0012] The upper and lower faces 2, 3 are both preferably formed with respective anchoring formations consisting of parallel indentations 2a, 3a.
[0013] The body 1 is hollow, thanks to the fact that a through opening in the form of a slot 6 passes vertically through it between the upper 2 and lower 3 faces. Furthermore, circular holes 7 pass through the side walls 4, 5 of the body 1.
[0014] As observable in figure 4, the body 1 has a height, measured between the upper 2 and lower 3 faces, which decreases slightly toward the rear end thereof, indicated with 8 and in which a recess 9 for the introduction of a tool for the surgical insertion of the cage into the intervertebral space. This instrument, not illustrated, is configured so as to engage axially and torsionally with the recess 9 so as to be able to rotate the body 1 alternately in a clockwise and anti-clockwise direction or vice versa while being simultaneously pushed.
[0015] A nose 11 - which has the function of paving the way by dilating the intervertebral space during the process for inserting the intersomatic cage - protrudes from the front end of the body 1, indicated with reference numeral 10.
[0016] The shape of the nose 11 is conveniently similar to that described and illustrated in the previously cited Italian patent application n° 102019000023913 on behalf of the Applicant in question, not published at the filing or priority date of the present application.
[0017] According to the distinctive characteristic of the invention, the body 1, made of biocompatible material, is formed with surface receptacles 12 containing slow prolonged release substances selected from the classes of anti-inflammatory, anti-infection and bone regrowth promoter drugs. These substances are inserted into the receptacles 12 in a semi-solid form, for example pasty, so as to fill them stably.
[0018] The surface receptacles 12 are in the form of surface gratings of grooves provided on the outer surfaces of at least both the side walls 4, 5 of the body 1, and on said nose 11. Due to the hollow shape of the body 1, the surface receptacles 12 are normally provided for both on the outer surfaces and on the inner surfaces of the side walls 4, 5. Furthermore, such receptacles 12 can also be formed on other parts of the body 1, and in particular are also formed on the nose 11.
[0019] The arrangement represented in the drawings with orthogonal intersections of the surface gratings of grooves which form the receptacles 12 is provided purely by way of example, given that different arrangements which allow to maximise the amount of drugs that can be applied to the body 1 can also be envisaged.
[0020] Typically the pharmacological substances can be the following: Growth promoters: drugs also with multimodal action, combining chemotactic, mitogenic, morphogenic, metabolic or apoptotic factors. They include BMP (bone morphogenetic proteins), in particular BMP-2 and BMP-7; VEGFs (vascular endothelial growth factors), which have been studied to promote the growth of blood vessels for the vascularisation of the bone; fibroblast growth factors. The use of statins has also been shown to promote the expression of BMP-2 in mRNA in osteoblasts. Anti-infection: primarily broad spectrum antibiotics such as gentamicin and vancomycin Usual anti-inflammatory agents.
[0021] These substances are then normally added to excipients of various conventional types suitable to facilitate both their stability inside the receptacles 12 and the slow release thereof.
[0022] Obviously, the construction details and the embodiments may widely vary with respect to what has been described and illustrated, without departing from the scope of protection of the invention as described in the claims that follow.
Claims
1. Intersomatic cage for vertebral stabilization, comprising a generally prismatic body (1) having an upper face (2) and a lower face (3; with reference to the implanted position of the cage in the intervertebral space of a subject 10 with an upright spine), side faces (4, 5) and a protruding nose (11) and designed to be inserted between two contiguous vertebrae so as to space them apart during the surgical insertion of the cage, characterised in that the body (1) is formed with receptacles (12) containing slow prolonged release substances selected from the classes of anti-inflammatory, anti-infection and bone regrowth promoter drugs, characterised in that the receptacles (12) are in the form of surface gratings of grooves provided on the outer surfaces of at least both the side walls (4, 5) of the body (1) and said nose (11).
2. The intersomatic cage according to claim 1, characterised in that the body (1) is hollow and said surface receptacles (12) are provided for on the inner and outer surfaces of said side walls (4, 5) of the body (1).