KR101276414B1 - Flexible space holder - Google Patents

Abstract

The present invention relates to at least one biocompatible, rigid material flexible space holder having a tubular body (1) for temporary or permanent implantation into a human or animal body, by means of a material recess The above flexible areas are provided therein.

Space Holder, Tubular Body, Connection, Graft, Muscle Tissue, Intervertebral Disc, Spine

Description

Flexible space holder {Flexible space holder}

1 is a three-dimensional view of a space holder for a vertebral or intervertebral disc;

2 is a side view of the space holder of FIG. 1;

3 is a side detail view of the space holder of FIGS. 1 and 2;

4A-4C are views of another space holder; And

5A-5C are views of the third space holder.

Description of the Related Art

1: cylindrical body 2: connecting element

3, 203: tooth part 4: cavity

5: groove 6: fillet

7, 107, 207: recess 8: rotation axis

9: length axis 10, 100, 200: space holder

11, 111, 211: wall 101, 201: tubular body

125, 126, 225, 226: end plate

127, 227: external threads 128, 228: internal threads

129, 229: opening 230: sleeve

The present invention relates to a flexible space holder according to the generic part of claim 1.

In modern medicine, the effect can be compensated or minimized as a large number of defects in the human or animal body use implants (or space holders). For example, space holders for vertebrae or intervertebral discs are known that function to replace the vertebrae body or intervertebral discs.

In the context of space holders, it is important to use materials that, in other words, replaceable with human or animal organs, do not burden the organs or cause rejection due to collapse. Thus, the choice of material for the space holder is substantially limited.

In addition, it is advantageous to form the space holder as simple as possible, in particular with a small number of parts, since the assembly of the parts leads to an increase in the cost of inserting the space holder, and on the other hand Interconnected aspects can lead to greater infection errors and thus the possibility of dysfunction. To date, it is highly desirable to form the space holder integrally.

In contrast, however, the space holders should perform other functions that seem to be desirable to use other materials and / or to assemble the space holder from some parts. For example, spacers that fill spaces and perform functions that secure vertebrae at any point between each other, and that facilitate any movement of the vertebrae towards each other, ie, perform joint function within any narrow limits desirable. For this purpose, for example, in German patent DE 10056977 C2, a tube of bellows-shaped pieces made of a longitudinally extendable and tightly woven or knitted fabric of the space holder between the vertebral bodies and adjacent support elements is arranged. It is desirable to provide a space holder accordingly. However, this has the above-mentioned problems, such as the fact that several different materials that must be connected to each other must be used, that is, increase the degree of infection.

Therefore, the object of the present invention is to create the simplest possible parts, in particular only one or very few pieces, which are easy to connect with each other, and a space allowing any flexibility and mobility within the implant or its area in addition to other functions. To provide holders. In addition, these space holders must be easy to manufacture and implant, safe to operate and have a long life and have a variety of applications.

This object is achieved by space holders having the features according to claim 1. Useful embodiments are the purpose of the dependent claims.

For space holders, the prior art is that mobility or elasticity is obtained from additional parts and / or other kinds of materials. The present invention is not valid by materials of different flexibility or mobility or by the provision of additional individual parts, and in the case of integrated space holders or space holder parts, the area where the flexibility or mobility must be provided for the design of the material recesses. It takes a means that is achieved by manufacturing.

According to the invention, the space holders have a tubular body with material recesses, which together with the central tubular body part, have connection elements provided at their ends and which give rise to the flexibility provided in the central tubular body part.

The connecting elements of the space holders have corresponding means for connecting the space holder and adjacent body parts, such as the vertebrae, in the form of hook-like protrusions on their ends and / or recesses, recesses and openings on the sheathing surface so that the space holder is It is desirable to connect with and grow into muscle tissue. In this respect, however, the cavities or recesses of the connecting elements should not be confused with material recesses that achieve the flexibility and mobility of the space holder of the tubular body part. The connecting elements do not provide flexibility or mobility of the vertebrae because they are completely bonded to adjacent body parts such as the vertebrae.

In this way, by avoiding additional elastic materials and corresponding connecting parts or additional individual parts, flexibility and mobility can be obtained simply within the space holder or parts thereof. In this regard, the flexibility and mobility functions may be provided in addition to the essential functions of the space holder or as elements of the essential functions. In particular, it is possible to realize compression, torsional and / or stretching zones in a simple and reliable way, in particular in a single space holder.

Correspondingly, it is possible to use stable, rigid, preferably flexible, rigid materials, such as titanium, titanium alloys, plastics, etc., which are preferably integrally formed with a rigid, particularly rigid for conditions intended for use. In general, all biocompatible materials that do not exhibit any decay phenomena that cause rejection or burden on the human body can be candidates.

The workpiece recess may preferably be provided in the form of a recessed recess or an open opening gap in the wall in the tubular body portion. The shape, number and arrangement of the material recesses can be adjusted according to the load requirements.

As a universal shape that satisfies various requirements, the material recess can be provided in a spiral shape, in particular running around the tubular body, and thus in the form of a spiral spring result, which is adjacent to the spiral spring element because of the material recess. The advantage is that there is a free space between the valleys. In addition to easier manufacturability and associated larger selection of materials, this has the advantage of achieving greater flexibility.

Particularly convenient, two material recesses may be provided, such as formed as a double track or double wing helix. In this way, two spiral springs can be formed which are arranged inwardly to each other. If the regions of the spiral recesses have the same height, two spiral recesses of double pitch may be provided instead of one spiral recess of low pitch.

The means for connecting the tubular body to the adjacent body part may in particular be detachably formed on the end, such as an end plate extending from this body at the end to be integral with the tubular body or screwed over the end of the tubular body.

Around the tubular body with the material recesses, such detachable end plates or tubular bodies in case the sleeve of at least one elastic material is arranged or at least one elastic core is provided for the purpose of achieving elasticity or mobility. It is preferred that an end plate is integrally connected with the. Such elastic cores or preferably elastic sleeves of elastomers provide the advantage of allowing elasticity or rigidity to the precisely adjusted tubular body or space holder. Notwithstanding the modular arrangement of the core and / or sleeve with a tubular body with corresponding recesses, the use of other components of different stiffness can affect the precisely defined stiffness of the space holder in terms of damping in a simple manner. have. To date, a combination of a space holder part with a material recess to achieve flexibility and a space holder part composed of a flexible material to adjust the defined stiffness is a very general object of the present invention.

In order to achieve a changed stiffness, only a combination of components has to be changed, ie another core or other sleeve of different rigidity must be used as the flexible tubular body. Although considering that the sleeve and core may be used simultaneously with the flexible tubular body, for simplicity it will usually only be a tubular body and a combination of core or tubular body and sleeve. In this respect, the sleeve can also provide the advantage of protecting the tubular body, preferably with helical recesses, from external influences, whereas the core is protected by the tubular body when the core is used.

Both the core and the sleeve can conveniently be fixed by the placement of the end plate on the end of the tubular body, where the end plate protects more than the tubular body and thus has a larger diameter than the tubular body. The end plate is connected at least partly, ie integrally with the tubular body on one side, whereby a beaker shape can be obtained. In addition, the end plates can be detachably connected to the tubular body on one or both sides, for example via screw or threaded connections. In this respect, external threads may be provided on both the end plate and the tubular body.

Preferably, in order to achieve flexibility and mobility, the space holder or tubular body with material recesses can be stretched or compressed by 0.5 to 20% in the longitudinal direction along the length axis of the space holder, specifically 1 to 15%, And bend about a radial axis of rotation perpendicular to the length axis of the space holder, so that the connecting means (or connecting elements) for connecting to the adjacent body part are approximately 0.5 to 10 ° with respect to the length axis, in particular 1 to By 6 °, and in addition, in a preferred embodiment, a torsional movement of 0.5 to 5 °, in particular 0.5 to 2.5 °, is possible with respect to the longitudinal axis.

Further advantages, features and features of the present invention will become apparent from the following detailed description of two embodiments, which is supplemented by the accompanying drawings. The drawings are shown in a purely schematic manner.

Preferred Embodiments of the Invention

1 is a three-dimensional view of a first embodiment of a space holder according to the invention, in the form of a space holder for a vertebrae or intervertebral discs. The space holder 10 comprises a cylindrical body 1 and two connecting elements provided at the end of the cylindrical body 1 for connecting the space holder 10 to adjacent body parts, such as bone or cartilage tissue of the human body ( Has 2).

The connecting elements 2 arranged at the end of the cylindrical body 1 have the same shape as shown in the example embodiment, but may also have other shapes. The connecting elements 2 have teeth 3 which engage with adjacent body tissue in the state of being implanted at each free end of the end thereof.

The toothed portion 3 is formed by triangular grooves 5 at both ends of the space holder 10, so that a trapezoidal toothed portion 3 is formed which is able to engage and stick to adjacent body tissues.

In addition, the connecting elements 2 have diamond shaped cavities 4 (see FIG. 2) and are provided to be adjacent to each other along the entire cylindrical sheathing surface of the connecting elements 2. As a result, the individual connecting elements are themselves re-formed by a large number of interconnected fillets 6 with a diamond tip formed by the cut fillets 6 and thus trapezoidal teeth ( 3) is formed.

The tubular body 1 between the connecting elements 2 at both ends of the cylindrical body has a spiral material recess 7, as shown in this embodiment, so that the wall 11 itself takes a spiral shape. (See FIG. 3). Otherwise, the space holder 10 is formed as a hollow cylinder as a whole, so if the space holder 10 itself is formed of an essentially hard material such as titanium or a titanium alloy, it is provided with a material recess 7. The tubular body 1 between the connecting elements 2 represents an elastic region or a moving region. Through the material recess 7, the space holder 10 receives the elasticity associated with it in the region of the tubular body 1, and it is possible to dispense the provision of the individual elastic material in this region to obtain individual elasticity or mobility. Let's do it. In particular, this makes it possible to avoid the need to make a space holder from several parts that must be fixed together.

Through the helical material recess 7, the stretch and compressibility of the tubular body 1 along the length axis 9 of the space holder 10 and the axis of rotation perpendicular to the length axis 9, for example a radial axis of rotation 8. Bendability is obtained in a simple manner with respect to the axis of rotation shown in FIG. 2). Here, in particular, the helical shape of the material recess 7 promotes and demonstrates its value in balancing elasticity or mobility in most distinct directions. However, using suitable solutions or possible load profiles in individual cases, other shapes of workpiece recesses and other numbers and arrangements of such workpiece recesses are naturally possible and acceptable.

4 shows a second embodiment of a space holder 100 with a tubular body 101 which is sealed by the end plate 125 integrally connected with the tubular body 101 and thus results in a beaker shape. Three different three-dimensional developments (FIGS. 4A-4C) and sub-views of the cross-sectional view (FIG. 4B) are shown.

The tubular body 101 has its own wall 111 with a spiral material recess 107 which exhibits any flexibility according to the invention as a tubular body 101.

In order to be able to precisely adjust the firmness of the space holder 100, of elastomeric material fixed at the upper side by the end plate 126 in the tubular body 101 and at the lower side by the end plate 125. A replaceable core element 130 is provided in the tubular body 101.

The end plate 126 on the upper side of the space holder has an outer thread 127, through which it can be tightened with the inner thread 128 of the tubular body 101 at the upper end inside the tubular body 101. The end plate 126 has a shoulder that sits firmly on the wall 111. A tooth 103 is provided along the entire end of the wall 111 and can engage with adjacent tissue to protect the end plates 125 and 126 and to securely hold the space holder in place.

The end plate 126 has an engaging opening 129 through which the end plate 126 can be tightened into the tubular body 101. End plates 125 and 126 may be roughened or coated with a bio-active material to assist in engagement with adjacent body tissue.

FIG. 5 shows sub-views of a third embodiment of a space holder and includes FIGS. 5A-5C showing three-dimensional developments, while FIG. 5B shows a three-dimensional cross section. In the embodiment of FIG. 5, the tubular body 201 again has a spiral material recess 207 in the body wall 211.

On the lower side, the tubular body 201 is closed again by an integrally arranged end plate 225, whereby the beaker shape of the tubular body 201 is again resulting. Obviously, the end plate 225 is formed to have a larger outer diameter than the tubular body 201 in which the spiral material recess 207 is disposed. This results in a shoulder that is configured to accommodate the tubular sleeve 230 of elastic material. The elastic sleeve 230 pushes out the entire tubular body 201 and is thus completely surrounded by the sleeve. In the upper section, the end plate 226 is tightened to the tubular body 201 via threaded connections. In this regard, the outer thread 227 of the end plate 226 engages with the inner thread 228 of the tubular body 201, so that the sleeve 230 is fixed between the end plates 225 and 226. The sleeve 230 also functions to adjust the overall stiffness by simply exchanging the sleeve 230 in a manner similar to exchanging the core 130 (see FIG. 4), and simply stiffens the overall rigidity of the space holders 100 and 200. Make it possible to change.

End plates 226 and 225 are provided with pyramid-shaped teeth 203 that function to engage adjacent tissue to strongly engage the space holder.

The lid 226 also has an engagement opening 229 through which the end plate 226 can be tightened over the tubular body 201.

According to the invention, the simplest possible parts, in particular only one or very few pieces that are easy to connect with each other, and space holders which permit any flexibility and mobility within the implant or its area in addition to other functions Can provide. In addition, these implants are easy to manufacture and implant, are safe to operate and have a long lifetime and are versatile in application.

Claims (14)

At least one biocompatible material having a tubular body 1 and connected to an adjacent body part at the end of the tubular body, having a space securing function and a load transfer function for temporarily or permanently inserting into a human body or an animal body; In the space holder for the vertebra or intervertebral disc composed of the connecting means (2), The tubular body is provided with material recesses for locally reducing rigidity, The space holder functions with a tubular body and material recesses for flexibility, and is fixed by an end plate integrally or separably arranged on the tubular body, each consisting of an elastic biocompatible material and a sleeve and core A defined rigidity or flowability of the entire space holder can thus be set, the space holder being compressible in the axial direction and extensible, and having a radial axis of rotation relative to the connecting means 2 provided at the end ( A space holder which can be bent about 8) and can be twisted about an axis of rotation. The method of claim 1, A space holder, characterized in that the tubular body (1) and the connecting means (2) connected to the adjacent body part are integrally formed from a single material. The method of claim 1, The biocompatible material of the tubular body (1) is a space holder, characterized in that the rigid material. The method of claim 1, And said biocompatible material is selected from the group comprising titanium and alloys thereof in combination with plastics. The method of claim 1, Wherein the material recesses are spiral material recesses and are formed like grooved recesses or open gaps in the wall. The method of claim 1, A space holder, characterized in that the two material recesses are formed as recessed recesses or open gaps arranged in a double spiral into each other. delete The method of claim 1, The connecting means (2) for connecting the tubular body portion (1) to the adjacent body portion has a projection for engaging with an adjacent body portion such as bone, cartilage and the like. The method of claim 1, The connecting means 2 for connecting the tubular body part 1 to the adjacent body part is formed as an extension of the tubular body part formed integrally with the tubular body part 1, wherein the recess, groove for growing into the muscle tissue And openings are provided in the coating surface. The method of claim 1, A connecting means (2) for connecting the tubular body part (1) to an adjacent body part is arranged on an end plate detachably arranged at the end of the tubular body (1). The method of claim 1, The elastic material is a space holder, characterized in that the elastomer. The method of claim 1, Said sleeve or core being fixed by an end plate which is integrally or detachably arranged on said tubular body. The method of claim 1, And the space holder is elastically extendable or compressible by 0.5 to 20% in the longitudinal direction. The method of claim 1, The space holder can be elastically bent with respect to the radial axis of rotation 8, so that the connecting means 2 for connecting to the adjacent body part provided at the end is provided by 0.5 to 10 ° from the longitudinal axis 12 of the tubular body. Or the space holder can be twisted about an axial axis, so that the connecting means (2) for connecting to the adjacent body part can be twisted by 0.5 to 5 °.

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