JP5496962B2 - Flexible space holder - Google Patents

Description

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

  In modern medicine, many defects in the human or animal body can be compensated or minimized by using implants. For example, spine or intervertebral disc space holders that function as a substitute for the vertebral body or intervertebral disc are well known.

  For space holders, use substances that are compatible with human or animal organisms, that is, substances that do not cause rejection due to disintegration phenomena or do not burden the organism. is important. Thus, the choice of implant member is substantially limited.

  Furthermore, it is advantageous to make the space holder as simple as possible, in particular from a small number of parts. This increases the outlay of the operator who inserts the implant by assembling the parts. On the other hand, in the part where various parts are connected to each other, the error susceptibility, That is, there is a greater possibility of malfunction. Therefore, it is very preferable to form the implant integrally.

  Patent Document 1 discloses a stop device between spines having a helical elastic body, two struts, and two stop members. Patent Document 2 discloses a connecting device between vertebrae having a spring main body portion that connects two spiral annular bases.

US Pat. No. 5,423,816 US Pat. No. 5,423,817

  On the other hand, however, the space holder must fulfill different functions. For this reason, it is clearly desirable to use different parts and / or to assemble the space holder from several parts. For example, it not only fulfills the function of filling the space and keeps the vertebrae at a certain distance from each other, but also facilitates the vertebrae to move to some extent towards each other, i.e. within a certain narrow limit of the joint Performing the function is desirable for the spacer. For this purpose, it is possible to provide a space holder, for example according to DE10056977C2. In this method, a bellows-like tubular piece made of a woven fabric or a knitted fabric that can be pulled in the longitudinal direction of the implant is disposed between the support members that contact the spine portion. However, this has the disadvantages described above. In other words, several different members that must be connected to each other must be used. That is, there is a possibility of increasing the occurrence of mistakes.

  The object of the invention is therefore to provide a space holder made from the simplest possible parts, in particular one piece or several pieces that are easy to connect. This not only ensures other functions, but also guarantees some flexibility and mobility within the implant or region thereof. Furthermore, these implants are easy to manufacture and implant, are safe to use, have a long life span and wide applicability.

This object is achieved by a space holder having the features according to claim 1. That is, a space holder for the spine and / or intervertebral disc, having space holding and weight transfer functions, introduced temporarily or permanently into the human or animal body, and provided at the end of the tubular body and the tubular body A space holder comprising at least one biocompatible member having a coupling means with an adjacent body part, wherein the wall of the tubular body has a groove-like depression shape to locally reduce rigidity. It is characterized in that a member recess that functions is provided. The tubular body is surrounded by a sleeve made of an elastic biocompatible material and / or a core made of an elastic biocompatible material is provided, and at least one of the sleeve and the core is provided on the tubular body. The at least one end plate is detachably provided on the tubular body by screw connection, and the space holder functions together with a portion of the space holder having a member recess, The ultimate rigidity or mobility of the entire holder can be set, the space holder is axially compressible and tensionable, bent around the radial axis of rotation with respect to the connecting end provided at the end It is also suitable to achieve flexibility so that it can be twisted about the longitudinal axis. Also useful embodiments of this feature are subject to the dependent claims.

  In the case of a space holder, in the prior art, mobility or elasticity has been obtained by using additional parts and / or different types of members, but the present invention employs another method. In other words, flexibility or mobility is not obtained by providing another member or additional separate part, but in the case of a monolithic implant or implant part, the region to be flexible or movable is This is possible by providing a member recess in design.

  According to the present invention, the space holder has a tubular body including a connection member provided at an end portion and a central tubular body portion, and the central tubular body portion is provided with a member recess that allows flexibility. ing.

  The connection member of the space holder preferably has connection means corresponding to the adjacent body part (such as the spine). This means is in the form of a hook-like protrusion provided at the end and / or a recess, groove, and opening on the jacket surface, with the space holder extending into the tissue and closely contacting it Like that. In this regard, the holes and recesses of the connection member should not be confused with the member recesses in the tubular body portion for realizing the flexibility and mobility of the space holder. Since the connecting member is in intimate contact with adjacent body parts (such as the spine), it does not contribute to the flexibility or mobility of the spine.

  In this way, flexibility and mobility can simply be obtained in the space holder or its parts, avoiding additional elastic members and corresponding connecting parts or additional separate parts. In this regard, an elastic or mobile function can be provided in addition to or as a component of the necessary function for the space holder. In particular, in this usage, compression, twisting and / or expansion zones can be realized in a simple and reliable way, especially in an integrated space holder.

  Correspondingly, a suitably rigid member (titanium, titanium alloy, plastic, etc.) that is stable and rigid, particularly hard in the intended use conditions, preferably flexible and rigid, is preferably used for the space holder that is preferably integrally formed. It is possible to use. In general, all biocompatible members are candidates for members that do not cause a rejection reaction and do not exhibit a collapse phenomenon that imposes a burden on the body.

Member recess, it is preferable to be provided as a recessed viewed shape groove shape formed in the wall of the tubular body portion. The shape, number, and structure of the member recesses can be adjusted for each case according to load conditions.

  The member recess can be provided as a general-purpose shape satisfying various requirements, in particular, as a spiral shape formed around the tubular body so that a spiral spring can be formed. This is particularly advantageous in that there is a free space between adjacent fillets of the helical spring element due to the member recess. According to this, manufacturing is easy, and there is an advantage that greater flexibility can be realized besides the wide selection range of members.

  In particular, the two member recesses are preferably provided like a pair of grooves or two flight helixes. In this method, in particular, two helical springs can be combined and incorporated in each interior. If the regions of the spiral-shaped recess have the same height, it is possible to provide two spiral-shaped recesses with a double pitch instead of a single spiral-shaped recess with a low pitch.

  Connecting means for connecting the tubular body to an adjacent body part may be provided at the end of the tubular body integrally with the tubular body, in particular this part as an extension. Alternatively, an end plate that can be screwed into the end of the tubular main body may be detachably provided at the end.

  Such a removable end plate, or an end plate integrally connected with the tubular body, is provided with a single elastic sleeve to obtain elasticity or mobility, or at least within the tubular body. When providing one elastic body core, it is preferable to provide it around the tubular body provided with a member recess. Such an elastic core or elastic sleeve, preferably an elastomer, allows the advantage that the elasticity or rigidity of the tubular body or space holder can be adjusted precisely. If the tubular body with corresponding recesses and cores and / or sleeves is configured in a modular manner, the precisely defined stiffness of the implant in the sense of damping in a simple manner by using different constructions of different stiffness Can be realized. Accordingly, it is a general object of the present invention to combine a space holder portion having a member recess for realizing flexibility with a space holder portion made of a flexible member for adjusting a prescribed rigidity. .

  To change the stiffness, it is only necessary to change the composition of the component. That is, for example, different cores or different sleeves of different stiffness need to be used with the flexible tubular body. It is conceivable to use the sleeve and core simultaneously with a flexible tubular body, but for simplicity, it will usually be only a tubular body and core, or a combination of a tubular body and sleeve. In this respect, the sleeve also has the advantage of protecting the tubular body with a suitable helical recess from external influences. On the other hand, when a core is used, the core is protected by the tubular body.

  Both the core and the sleeve have the advantage that they can be held by an end plate arrangement at the end of the tubular body. In the case of a sleeve arrangement, it is preferred that the end plate protrudes beyond the tubular body, i.e. has a larger diameter than the tubular body. The end plate is integrally connected to the tubular body so that it is at least partially, ie on one side, shaped like a beaker. Furthermore, the end plate can be detachably connected on one or both sides of the tubular body. This is done, for example, by connecting screws or threads. In this regard, it is possible to provide external threads on both the end plate and the tubular body.

A space holder or a tubular body with a recess for obtaining flexibility and mobility can be pulled 0.5 to 20%, in particular 1 to 15% in the longitudinal direction along the longitudinal axis of the space holder or Around a radial axis that is compressible and is perpendicular to the longitudinal axis of the space holder so that adjacent body parts can pivot about about 0.5-10 ° , in particular 1-6 ° Is preferably bendable. Furthermore, in a preferred embodiment, a torsional movement of 0.5 ° to 5 °, in particular 1 to 3 ° , is possible around the longitudinal axis.

It is a figure which shows the space holder for spine or an intervertebral disc in three dimensions. It is a side view of the space holder of FIG. FIG. 3 is a detailed side view of the space holder of FIGS. 1 and 2. (A)-(c) is a figure which shows the further embodiment of a space holder. (A)-(c) is a figure which shows the 3rd embodiment of a space holder.

  FIG. 1 shows the shape of a space holder for a spine or an intervertebral disc and shows a first embodiment of an implant according to the present invention in three dimensions. The space holder 10 has a cylindrical body 1 and two connection members 2 that are provided at the end of the cylindrical body 1 and connect the space holder 10 to an adjacent body part (for example, bone or cartilage in the human body). .

  In the example of the illustrated embodiment, the connecting member 2 configured at the end of the cylindrical body 1 has the same shape at both ends, but may have different shapes. The connecting member 2 has a serrated notch 3 at each free end. By this incision 3, it becomes possible to connect to an adjacent body tissue at a site to be implanted.

  The serrated notches 3 are triangular recesses 5 at both ends of the space holder 10 (see FIG. 2) so that trapezoidal serrated notches 3 that can be connected to the adjacent body tissue so as not to be separated therefrom are formed. It is formed by.

  Further, the connecting member 2 has a diamond-shaped gap 4 (see FIG. 2). The gap 4 is formed adjacent to each other around the entire cylindrical jacket surface of the connecting member 2. As a result, each connecting member is formed by a large number of diamond-type fillets 6 (see FIG. 2) connected to each other. At this time, the diamond-shaped tip is formed by a fillet 6 cut off so that a trapezoidal sawtooth-shaped cut 3 is formed.

  In the illustrated embodiment, the tubular body 1 between the connection members 2 at both ends of the cylindrical portion has a spiral member recess 7 in which the wall 11 (see FIG. 3) itself is spiral. Since the space holder 10 is entirely formed as a hollow cylindrical portion, the tubular body 1 between the connecting members 2 having the member recesses 7 is made of titanium, titanium alloy, or the like. Even if it is formed of an essentially hard material, it becomes an elastic region or a moving region. The space holder 10 exhibits design elasticity in the region of the tubular body 1 by the member recess 7. Accordingly, elasticity or mobility can be obtained without providing another elastic body in this region. In particular, this avoids having to make a space holder by combining several parts.

  Due to the helical member recess 7, the tensile and compressible properties of the tubular body 1 along the longitudinal axis 9 of the space holder 10 and the axis of rotation (eg axis 8 (FIG. 2)) perpendicular to the longitudinal axis 9. The bendability around (shown) is obtained in a simple way. Here, it turned out that it is especially important that the member recessed part 7 is helical. This facilitates balanced elasticity or mobility in almost all directions. However, as a matter of course, other shapes of member recesses and different numbers and configurations of member recesses can be used and devised. Moreover, it is also possible to set it as the solution applied according to each case and load condition.

  FIGS. 4A to 4C are three different exploded views showing the second embodiment of the space holder 100 having the tubular body 101 in three dimensions, and FIG. 4B is a cross-sectional view. The space holder 100 is sealed on the lower side so as to be shaped like a beaker by an end plate 125 integrally connected to the tubular main body 101.

  The tubular body 101 has a spiral recess 107 formed in the wall 111 thereof. The recess 107 provides the tubular body 101 with a certain degree of flexibility according to the present invention.

  In order to adjust the hardness of the space holder 100 accurately, an exchangeable core member 130 of an elastomer member is provided inside the tubular main body 101. The core member 130 is held in the tubular body 101 by the end plate 125 on the lower side and by the end plate 126 on the upper side.

  The end plate 126 on the upper side of the space holder has a male screw 127. Thereby, the end plate 126 is engaged with the internal thread 128 of the tubular body 101 at the upper end inside the tubular body 101. Each of the end plates 126 has a shoulder. With this shoulder, the end plate 126 is provided in close contact with the wall 111. A serrated notch 103 is provided around the entire end of the wall 111 and protrudes over the end plates 125, 126 to engage adjacent tissue and hold the space holder fixed in place.

  The end plate 126 has an opening 129 for bonding. The opening 129 allows the end plate 126 to be joined to the tubular body 101. The end plates 125, 126 are further roughened or coated with a biocompatible member to facilitate bonding with adjacent body tissue.

  (A)-(c) of Drawing 5 shows a 3rd embodiment of a space holder. (A)-(c) is an exploded view shown in three dimensions, (b) is sectional drawing shown in three dimensions. In the embodiment of FIG. 5, the tubular body 201 also has a spiral recess 207 formed in the body wall 211.

  On the lower side, the tubular body 201 is closed by an end plate 225 integrally formed so that the tubular body 201 is shaped like a beaker, and a spiral member recess 207 is provided. The end plate 225 is formed to have a larger outer diameter than the tubular body 201, thereby forming a shoulder. This shoulder portion constitutes a portion with which the tubular sleeve 230 of the elastomer member abuts. The elastic sleeve 230 is attached to the tubular body 201 so that the sleeve completely surrounds the circumference. On the upper end side, the end plate 226 is engaged with the tubular body 201 by screw connection. At this point, the male thread 227 of the end plate 226 engages the female thread 228 of the tubular body 201 so that the sleeve 230 is fixed and held between the end plates 225 and 226. The sleeve 230 also adjusts the overall stiffness by allowing the overall stiffness of the implants 100, 200 to be easily changed in the same manner as the exchange core 130 (see FIG. 4) simply by replacing the sleeve 230. To function.

  Pramid serrated notches 203 are provided on the end plates 226 and 225 that function to connect to adjacent tissue and secure the space holder.

  The lid 226 is also provided with a bonding opening 229. This opening 229 allows the end plate 226 to engage the tubular body 201.

  DESCRIPTION OF SYMBOLS 1 Tubular main body, 2 connection member, 3 serrated cut, 4 clearance, 6 fillet, 7 member recessed part, 8 axis, 9 longitudinal axis, 10 space holder, 11 wall.

Claims (16)

Space holder for spine and / or intervertebral disc, having space holding and weight transfer function, temporarily or permanently introduced into a human or animal body, and provided at a tubular body and an end of the tubular body A space holder comprising at least one biocompatible member having a coupling means with an adjacent body part,
The wall of the tubular body is provided with a member recess that functions to locally reduce rigidity in a groove-like depression shape.
A space holder characterized by that. The space holder according to claim 1,
The tubular body is surrounded by a sleeve made of an elastic biocompatible material and / or provided with a core made of an elastic biocompatible material;
At least one of the sleeve and the core is held by an end plate provided on the tubular body, and at least one of the end plates is detachably provided on the tubular body by a screw connection,
The space holder functions together with the part of the space holder having a member recess to set the final rigidity or mobility of the entire space holder, and the space holder is axially compressible and tensionable, Realizing flexibility so that it can be bent around a rotational axis in the radial direction and twisted around a longitudinal axis with respect to a connecting end provided in the section;
A space holder characterized by that.   The space holder according to claim 1 or 2, wherein the coupling means between the tubular body and the adjacent body part is integrally formed from one member.   The biocompatible member of the tubular body is a member having rigidity, and is a member having bending rigidity under intended use conditions. Space holder.   The space holder according to any one of claims 1 to 4, wherein the biocompatible member is selected from a group including titanium, a titanium alloy, and plastic. The space holder according to claim 1 , wherein the member recess is formed in a spiral shape . The space holder according to any one of claims 1 to 6,
The space holder is characterized in that the two member recesses are formed as groove-like depressions configured like a pair of spiral tracks inside each other.   The means for connecting the tubular body part to an adjacent body part extends in the axial direction of the tubular body part, in particular in the axial direction, extending from a sawtooth incision having a triangular or trapezoidal shape for connecting to an adjacent body part such as bone or cartilage. The space holder according to any one of claims 1 to 7, further comprising a protruding portion. The means for connecting the tubular body part to an adjacent body part is formed as an extension of the tubular body part and is integrally formed with the tubular body part;
The space holder according to any one of claims 1 to 8, wherein a recess, a groove, and an opening are provided on a jacket surface extending into the tissue.   The means for connecting the tubular body part to an adjacent body part is provided on an end plate configured to be detachable from an end part of the tubular body part. Space holder according to item.   The space holder according to any one of claims 1 to 10, wherein the elastic body is an elastomer.   The space holder according to any one of claims 1 to 11, wherein one of the end plates is integrally formed with the tubular body.   The space according to any one of claims 1 to 12, wherein the space holder and the tubular body are elastically tensionable or compressible in the longitudinal direction by 0.5 to 20%. holder.   The space holder according to any one of claims 1 to 13, wherein the space holder and the tubular body are elastically tensionable or compressible by 1 to 15% in a longitudinal direction thereof.   The space holder and the tubular body are elastic about a radial axis so that the means on the end connecting the adjacent body parts can pivot about 0.5-10 ° from the longitudinal axis of the tubular body Or the space holder and the tubular body can be twisted about an axis so that the means for connecting with the adjacent body part can be twisted 0.5-5 ° Item 15. The space holder according to any one of items 1 to 14.   The space holder and the tubular body are elastically bent around a radial axis so that the means for connecting adjacent body parts provided at the end can pivot about 1-6 ° from the longitudinal axis of the tubular body The space holder and the tubular body are capable of being twisted about an axis so that the means for connecting to the adjacent body part can be twisted by 1 to 3 °. The space holder according to any one of the above.

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