Patent Description:
An example of this technology is recited in Patent Literature <NUM>. A spinal fusion system recited in Patent Literature <NUM> includes screws fixed to vertebral bodies, which are regarded as fixing members, and rods connecting the screws with each other. As shown in, for example, <FIG> of Patent Literature <NUM>, two screws are screwed (punctured) into and fixed to a vertebral body in each vertebra. The relative positions of neighboring vertebral bodies are fixed by two groups of screws and rods, which are arranged to be in parallel. The document further recites that, in order to further firmly fix the vertebral bodies with each other, the neighboring rods may be connected to each other by a lateral connector.

Although not clearly recited in Patent Literature <NUM>, the screws, the rods, and the lateral connector are made of a metal material such as titanium.

[Patent Literature <NUM>] Published <CIT> (Tokuhyo <NUM>-<NUM>).

Further related prior art may be found in <CIT> which describes an implant for laminoplasty and system and in <CIT> which describes orthopedic stabilization devices and methods for installation thereof.

The known spinal fusion implant recited in Patent Literature <NUM> completely fixes the neighboring vertebral bodies to each other. Because the relative positions of the completely fixed vertebral bodies do not change at all, the rotation range of the waist of the patient is narrowed after the surgery, and it becomes difficult to rotate the waist. The daily life of the patient may therefore be affected after the surgery. Furthermore, a bone fracture may occur between the completely fixed vertebral body and a neighboring vertebral body which is not fixed. The rotational angle of five lumbar vertebrae (vertebrae) is typically about <NUM> degrees, and hence the rotational angle per each vertebral body is about <NUM> degrees.

In addition to the above, the known spinal fusion implant recited in Patent Literature <NUM> involves the following problem. When an operator screws a screw into a vertebral body, erroneous screwing (erroneous puncture) occurs at a nonnegligible rate
(about <NUM> to <NUM>%). In this regard, a spinal cord extends in a spinal canal which is between a vertebral body and a vertebral arch constituting a vertebra. The heart, various organs, the aorta, the vena cava, etc. are on the belly side of the vertebral bodies. When, for example, the spinal cord is damaged by erroneous screwing (erroneous puncture) of a screw, neuralgia or paralytic symptoms may occur. Furthermore, massive hemorrhage may occur when a large vessel such as the aorta is damaged.

In order to prevent the occurrence of erroneous screwing (erroneous puncture) of a screw into a vertebral body, some hospitals have three-dimensional monitoring systems (navigation systems) which are very expensive. However, not all hospitals are able to have such systems for various reasons.

The present invention has been done under the circumference described above, and an object of the present invention is to provide a spinal fusion implant by which the rotatability of vertebral bodies is less hindered and erroneous screwing (erroneous puncture) of a screw is prevented.

The present invention is defined by the appended independent claim. The dependent claims describe optional features and distinct embodiments.

A spinal fusion implant provided by the present invention, which keeps relative positions of neighboring vertebral bodies to fall within a predetermined range, includes: screws connected to vertebral bodies; at least two connection plates in each of which guide holes into which the screws are inserted from a back side surface toward a belly side surface are formed at both end portions; and a center rod which connects neighboring ones of the connection plates which are fixed to the vertebral bodies by the screws. Each of the connection plates has, on the belly side surface, protrusions which are fitted into concave portions of intervertebral joints, and a center hole into which the center rod is slidably inserted is formed in side surfaces of each of the connection plates so that the center of the center hole is on the back side of an imaginary line which connects middle points of arc-shaped contour lines of the concave portions of the neighboring intervertebral joints when viewed from the head side of a human body.

As described in The Physiology of the Joints written by I. Kapandji, which is renowned in the field of orthopedics, the assumed rotation center of a vertebral body is positioned at the center of an imaginary circle assumed from arc-shaped contour lines of the concave portions of the intervertebral joints when viewed from the head side of the human body. The center of the center hole into which the center rod is slidably inserted may not be identical with the assumed rotation center of the vertebral body, but the assumed rotation center of the vertebral body is on the back side of the vertebral body. The vertebral body is therefore rotatable about the center rod together with the connection plate, and hence the rotation of the vertebral body is less hindered. In addition to the above, the connection plate has, on the belly side surface, the protrusions which are fitted into the concave portions of the intervertebral joints. This arrangement allows the connection plate to be closely in contact with the back side of the vertebra. This minimizes the rattling and deviation of the screw in screwing (puncture). Furthermore, as the protrusions of the connection plate are fitted into the concave portions of the intervertebral joints, the screwing positions and angles of the screws are correctly determined. As a result, the occurrence of erroneous screwing (erroneous puncture) is prevented as compared to conventional ones. Furthermore, because the belly side surface of the connection plate contributes to the integration of the vertebra and the connection plate, bone fracture of the vertebra is prevented while the rotatability of the vertebra is less hindered.

According to the present invention, the center hole is positioned at the center of an imaginary circle which is assumed from the contour lines.

This arrangement further facilitates the rotatability of the vertebral bodies.

According to a preferred embodiment of the present invention, the center rod is curved based on data of a row of vertebrae in an upright position.

This arrangement further facilitates the rotatability of the vertebral bodies when the patient is in an upright position, in particular when the patient is in action after the surgery.

According to a preferred embodiment of the present invention, the center rod is curved along an imaginary curve which is formed by connecting centers of imaginary circles assumed from the contour lines, in a direction in which the vertebrae are lined up.

According to a preferred embodiment of the present invention, positions and angles of the guide holes in each of the connection plates are determined for each of the vertebral bodies so that the screws are accommodated inside the vertebral bodies.

This arrangement prevents the spinal cord, the heart, the organs, or large vessels such as the aorta from being damaged by the screws, and the screws are screwed (punctured) more safely.

According to a preferred embodiment of the present invention, the center rod is made of a resin material or a carbon fiber material.

The resin material and the carbon fiber material have a certain degree of flexibility. For this reason, in addition to a lesser degree of hindrance to the rotatability of the vertebral bodies, the flexibility (front/back flexibility) of the vertebral bodies is less hindered.

According to a preferred embodiment of the present invention, the screws, the connection plates, and the center rod are made of a resin material or a carbon fiber material.

With this arrangement, in addition to a lesser degree of hindrance to the rotatability and flexibility of the vertebral bodies, the occurrence of an artifact which is a problem for metal implants is prevented.

According to a preferred embodiment of the present invention, the spinal fusion implant further includes a lateral rod which is provided on either side of the center rod to connect neighboring ones of the connection plates, the lateral rod being made of a resin material or a carbon fiber material.

With this arrangement, in addition to a lesser degree of hindrance to the rotatability of the vertebral bodies, the vertebral bodies are firmly fixed to one another.

According to a preferred embodiment of the present invention, the number of the connection plates is three or more and the connection plates are lined up in series, and at least two of the connection plates are further connected with one another by lateral rods which are provided on the respective sides of the center rod.

With this arrangement, a part where the rotatability of the vertebral bodies is preferred and a part where the fixation of the vertebral bodies is preferred can coexist.

The present invention is able to provide a spinal fusion implant by which the rotatability of vertebral bodies is less hindered and erroneous screwing (erroneous puncture) of a screw is prevented.

The following will describe an embodiment of the present invention with reference to figures.

The structure of a spinal fusion implant <NUM> of First Embodiment of the present invention will be described with reference to <FIG>. The spinal fusion implant <NUM> is an implant which keeps the relative positions of neighboring vertebral bodies <NUM> to fall within a predetermined range, and main components of this spinal fusion implant <NUM> are plural screws <NUM> fixed to the vertebral bodies <NUM>, at least two connection plates <NUM>, and a center rod <NUM> connecting the neighboring connection plates <NUM> with each other.

The phrase "keeping the relative positions of neighboring vertebral bodies <NUM> to fall within a predetermined range" indicates that the implant of the present invention does not completely fix vertebral bodies as in the case of the known spinal fusion implant, and is a spinal fusion implant with which the movability of the vertebral bodies is less hindered.

The screw <NUM> is a member by which the connection plate <NUM> is fixed to a vertebral body <NUM>, and includes a tapered screw part 1a, a cylindrical part 1b, a parallel screw part 1c, and a hexagonal prism part 1d, which are provided in this order from the leading end side. The screw <NUM> is made of resin (plastic), carbon fibers, metal, or a composite of these materials. (The same applies to the connection plates <NUM>, the center rod <NUM>, and later-described lateral rods <NUM>. ) Examples of the resin material include PEEK resin (polyether ether ketone resin) and PLA resin (polylactic resin). Examples of the metal material include titanium, titanium alloy, cobalt - chromium alloy, and stainless steel.

The connection plates <NUM> are members fixed to the vertebral bodies <NUM> by the screws <NUM> and connect the vertebral bodies <NUM> which are adjacent to each other by means of the center rod <NUM>. At the both end portions of the connection plate <NUM>, guide holes 3c are formed to allow the screws <NUM> to be inserted from a back side surface 3a to a belly side surface 3b opposite to the back side surface 3a.

Furthermore, the connection plate <NUM> has, on the belly side surface 3b, protrusions <NUM> which are fitted into concave portions of intervertebral joints <NUM>. A vertebra <NUM> is formed of components such as a vertebral body <NUM>, a vertebral arch <NUM>, intervertebral joints <NUM>, transverse processes <NUM>, pedicles <NUM>, and a spinous process. The spinous process has been removed from the vertebra <NUM> shown in <FIG>. The spinous process and the vertebral arch <NUM> have been removed from the vertebra <NUM> shown in <FIG>. Before screwing the screw <NUM> into the vertebral body <NUM>, the operator causes the protrusions <NUM> of the connection plate <NUM> to fit into the concave portions of the intervertebral joints <NUM>. As a result of this, the connection plate <NUM> is closely in contact with the back side of the vertebra <NUM>. This minimizes the rattling and deviation of the screw <NUM> in the subsequent screwing (puncture). The positions and sizes of the protrusions <NUM> on the belly side surface 3b are preferably determined for each vertebra <NUM>. For example, before the surgery, the shape and size of each vertebra <NUM> is measured in three dimensions by CT or MRI, and the positions and sizes of the protrusions <NUM> on the belly side surface 3b are determined in accordance with the concave portions of the intervertebral joints <NUM>, in accordance with the measurement result. Then the connection plate <NUM> is manufactured for each vertebra <NUM>.

The positions and angles of the guide holes 3c in the connection plate <NUM> are preferably determined for each vertebral body <NUM> so that each tapered screw part 1a (screw <NUM>) is accommodated inside the vertebral body <NUM> (see <FIG>). As described above, for example, before the surgery, the shape and size of each vertebra <NUM> is measured in three dimensions by CT or MRI, and the positions and angles of the guide holes 3c in the connection plate <NUM> are determined to be optimal for each vertebral body so that each tapered screw part 1a (screw <NUM>) is accommodated inside the vertebral body <NUM>, in accordance with the measurement result. This prevents the spinal cord, the heart, the organs, or large vessels such as the aorta from being damaged by the screws <NUM>, and the screws <NUM> are screwed (punctured) more safely.

A center hole 3d is formed in the side surfaces of the connection plate <NUM>. The center rod <NUM> is slidably inserted into this center hole 3d. The connection plates <NUM> and the center rod <NUM> are not completely fixed, and the connection plates <NUM> are rotatable about the center rod <NUM>.

Now, the following will describe the assumed rotation center of the vertebral body <NUM> to which the connection plate <NUM> is fixed, with reference to <FIG>. As described in The Physiology of the Joints above, it has been known that the assumed rotation center of a vertebral body <NUM> is the center O of an imaginary circle D shown in <FIG>.

This imaginary circle D is a circle assumed such that arc-shaped contour lines C of the concave portions of the intervertebral joints <NUM> substantially form parts of the circumference, when viewed from the head side of the human body. The contour line C of each intervertebral joint <NUM> is scarcely a mathematically complete arc. On this account, the arc-shaped contour line C substantially forms a part of the circumference and may not be completely matched with the circumference of the imaginary circle D.

In order to arrange the rotatability of the vertebral body <NUM> to be less hindered, the center of the center hole 3d into which the center rod <NUM> is inserted is formed in the side surfaces of the connection plate <NUM> so that, in a state in which the connection plate <NUM> is fixed to the vertebral body <NUM>, the center of the center hole 3d is on the back side of an imaginary line L1 which connects the middle points of the contour lines C of the neighboring intervertebral joints <NUM> when viewed from the head side of the human body. The middle point of the arc-shaped contour line C is a point P3 which is on the arc-shaped contour line C and is equally distanced from the both ends P1 and P2 of the contour line C.

The above-described center of the hole may not be identical with the assumed rotation center (i.e., the center O of the imaginary circle D) of the vertebral body <NUM>, but is on the back side of the vertebral body for which the center O of the imaginary circle D is assumed. The vertebral body <NUM> is therefore rotatable about the center rod <NUM> together with the connection plate <NUM>, and hence the rotatability of the vertebral body <NUM> is less hindered. As described above, the rotational angle of each vertebra constituting the lumbar vertebrae is small, i.e., about <NUM> degrees. For this reason, even if the center of the center hole 3d is not completely identical with the center O of the imaginary circle D, the vertebral body <NUM> is rotatable and hence the rotatability of the vertebral body <NUM> is less hindered.

The rotatability of the vertebral body <NUM> is further facilitated when, in a state that the connection plate <NUM> is fixed to the vertebral body <NUM>, the center hole 3d into which the center rod <NUM> is inserted is formed in the side surfaces of the connection plate <NUM> so that the center hole 3d is positioned at the center O of the imaginary circle D, which is the assumed rotation center of the vertebral body <NUM> (i.e., the center of the center hole 3d is identical with the center O of the imaginary circle D).

Before the surgery, the shapes and sizes of the intervertebral joints <NUM> of each vertebra <NUM> are measured in three dimensions by CT or MRI, and the assumed rotation center of each vertebral body <NUM> is determined based on the measurement result. In the state that the connection plate <NUM> is fixed to the vertebral body <NUM>, the center hole 3d is formed in the side surfaces of the connection plate <NUM> so that the center hole 3d is positioned at the determined rotation center.

The center rod <NUM> is a member for connecting neighboring connection plates <NUM> which are fixed to the vertebral bodies <NUM> by the screws <NUM>.

In order to further facilitate the rotatability of the vertebral bodies <NUM>, the center rod <NUM> is preferably curved based on the data of the row of vertebrae <NUM> in an upright position. The data of the row of vertebrae <NUM> in the upright position is acquired by, for example, radiography.

<FIG> is a side view of the five vertebrae <NUM> (lumbar vertebrae 50a to 50e) constituting the spinal column in the upright position. An imaginary curve L2 shown in <FIG> connects the centers O of the imaginary circles D shown in <FIG>, in the direction in which the vertebrae <NUM> are lined up. In other words, the imaginary curve L2 connects the assumed rotation centers of the vertebral bodies <NUM>, in the direction in which the vertebrae <NUM> are lined up. The center rod <NUM> is preferably curved along this imaginary curve L2. The depicted imaginary curve L2 penetrates the spinous processes. The spinous processes are removed in the surgery in order to allow the connection plates <NUM> to be fitted with the intervertebral joints <NUM>.

As described above, before the surgery, the shapes and sizes of the intervertebral joints <NUM> of each vertebra <NUM> are measured in three dimensions by CT or MRI, and the assumed rotation center of each vertebral body <NUM> is determined based on the measurement result. The imaginary curve L2 connects the assumed rotation centers of the vertebral bodies <NUM>, in the direction in which the vertebrae <NUM> are lined up.

In regard to the material, the center rod <NUM> is preferably made of a material with a certain degree of flexibility, e.g., resin (plastic) such as PEEK resin and carbon fibers. With this arrangement, in addition to a lesser degree of hindrance to the rotatability of the vertebral bodies <NUM>, the flexibility (front/back flexibility) of the vertebral bodies <NUM> is less hindered.

The following will describe how the spinal fusion implant <NUM> is used. To begin with, an operator cuts the back of the human body for a predetermined length so that the vertebrae <NUM> are exposed. Then the spinous processes are removed from implant-mounted part of the vertebrae <NUM>. The vertebral arch <NUM> is typically not removed, but may be removed from the vertebra <NUM> according to need.

Subsequently, the connection plate <NUM> is closely attached to the back side of the vertebra <NUM> as the protrusions <NUM> of the connection plate <NUM> are fitted into the concave portions of the intervertebral joints <NUM>. Then the screws <NUM> are inserted into the guide holes 3c of the connection plate <NUM>, and the screws <NUM> are screwed (punctured) into the vertebral body <NUM>. The operator puts a lug wrench on the hexagonal prism part 1d at the rear end portion of the screw <NUM>, and screws (punctures) the screw <NUM> into the vertebral body <NUM> along the guide hole 3c, by slowly rotating the lug wrench.

After the screwing of the screw <NUM> is completed, a nut <NUM> is threaded onto the parallel screw part 1c of the screw <NUM> from the back side, so that the connection plate <NUM> is fixed to the vertebra <NUM>. Subsequently, the center rod <NUM> is inserted into the center holes 3d of the neighboring connection plates <NUM>, so that the connection plates <NUM> are connected to one another.

The center rod <NUM> is not fixed to the connection plates <NUM>. The center rod <NUM>, however, hardly drops off from the connection plates <NUM> on account of the spinous processes, etc. which are on the front and back of the center rod <NUM> in the axial direction.

The structure of a spinal fusion implant <NUM> of Second Embodiment of the present invention will be described with reference to <FIG> and <FIG>. In the spinal fusion implant <NUM> of Second Embodiment, members identical with those of the spinal fusion implant <NUM> of First Embodiment are denoted by the same reference symbols. (The same applies to later-described Third Embodiment.

The spinal fusion implant <NUM> of Second Embodiment is different from the spinal fusion implant <NUM> of First Embodiment in that, in the spinal fusion implant <NUM> of Second Embodiment, some of the connection plates are connected with one another by lateral rods <NUM>, in addition to the center rod <NUM>.

The spinal fusion implant <NUM> includes three connection plates <NUM> provided in series, and two of these connection plates <NUM> are further connected with each other by lateral rods <NUM> which are provided on the respective sides of the center rod <NUM>.

At the connection plates where the lateral rods <NUM> are provided, preference is given to the fixation of the vertebral bodies <NUM>. Meanwhile, at the connection plate where the lateral rods <NUM> are not provided, preference is given to the rotatability of the vertebral bodies <NUM>. In this way, the force of fixing the vertebral bodies <NUM> is partially enhanced by connecting some connection plates with one another by the lateral rods <NUM>, in addition to the center rod <NUM>. As such, the force of fixing each vertebral body <NUM> is changed depending on whether to use the lateral rods <NUM>. A part where the rotatability of the vertebral bodies <NUM> is preferred and a part where the fixation of the vertebral bodies <NUM> is preferred can therefore coexist.

In the present embodiment, the lateral rods <NUM> are provided at the respective end portions of the connection plates <NUM>, and the lateral rods <NUM> are attached to the connection plates <NUM> by using pin members <NUM>. Each pin member <NUM> is composed of a ring-shaped rod holding portion 7a into which the lateral rod <NUM> is inserted and a leg portion 7b into which the screw <NUM> is inserted. In a state in which the lateral rod <NUM> is inserted into the rod holding portion 7a and the screw <NUM> is inserted into the leg portion 7b, a nut <NUM> is tightened from the back side. As a result, the leg portion 7b is elastically deformed and the lateral rod <NUM> is gripped by the rod holding portion 7a.

Alternatively, being similar to the attachment of the center rod <NUM> to the connection plate <NUM>, the connection plate <NUM> may be connected to the lateral rods <NUM> in such a way that holes are bored in the side surfaces of the both end portions of the connection plate <NUM> and the lateral rods <NUM> are inserted into these holes. The connection plates <NUM> may or may not be fixed to the lateral rods <NUM>. (The same applies to later-described.

The structure of a spinal fusion implant <NUM> of Third Embodiment of the present invention will be described with reference to <FIG> and <FIG>.

The spinal fusion implant <NUM> of Third Embodiment is different from the spinal fusion implant <NUM> of Second Embodiment in that, in the spinal fusion implant <NUM> of Third Embodiment, all of the connection plates are connected with one another by lateral rods <NUM> which are provided on the respective sides of the center rod <NUM>.

In this arrangement, in order to maintain the rotatability of the vertebral bodies <NUM>, at least the connection plates <NUM>, the center rod <NUM>, and the lateral rods <NUM> are made of a material with a certain degree of flexibility, e.g., resin (plastic) such as PEEK resin and carbon fibers. The spinal fusion implant <NUM> of the present embodiment is slightly inferior to the spinal fusion implant <NUM> shown in <FIG>, etc. having no lateral rods <NUM>, in terms of the rotatability of the vertebral bodies <NUM>. However, because the main components are made of a resin material or a carbon fiber material, the rotatability of the vertebral bodies <NUM> is less hindered in the spinal fusion implant <NUM> of the present embodiment, too.

In the spinal fusion implant <NUM> of the present embodiment, because two screws <NUM>, a connection plate <NUM>, and three rods (a center rod <NUM> and lateral rods <NUM>) form a sort of frame structure, the vertebral bodies <NUM> are firmly fixed while the rotatability of the vertebral bodies <NUM> is less hindered. Furthermore, on account of the frame structure, a load on each component of the implant is distributed.

In the spinal fusion implant <NUM> which is a prototype and shown in <FIG>, all of the screws <NUM>, the connection plates <NUM>, the center rod <NUM>, the lateral rods <NUM>, the nuts <NUM>, and the pin members <NUM> are made of PEEK resin. In this connection, because an artifact appears around the spine fixed by a metal implant during MRI or CT photography, it is difficult to grasp the state of spinal neoplasm or a state of fusion of a grafted bone. When the components are made of a resin material or a carbon fiber material as in the spinal fusion implant <NUM> of the present embodiment, it is possible to prevent the occurrence of an artifact.

The inventors of the subject application performed an experiment of attaching a prototype spinal fusion implant <NUM> shown in <FIG> to the vertebrae of a pig. The inventors screwed (punctured) screws <NUM> into the vertebral bodies <NUM> along the guide holes 3c of the connection plates <NUM> while closely attaching the protrusions <NUM> (see <FIG>) of each connection plate <NUM> to the concave portions of the intervertebral joints of the pig. As a result, the screws <NUM> were fixed to the vertebral bodies <NUM> without the occurrence of erroneous screwing (erroneous puncture). After the connection of the connection plates <NUM> by the center rod <NUM> and the lateral rods <NUM>, the rotatability of the vertebral bodies were confirmed by a hand.

<FIG> is a photograph showing a state in which a spinal fusion implant <NUM> made of PEEK resin has just been attached to the vertebrae of a pig with its back cut open. <FIG> and <FIG> are a CT image and an MRI image of the back portion of the pig in which the spinal fusion implant <NUM> is attached to the vertebrae (i.e., embedded in the body).

In the spinal fusion implant <NUM>, three connection plates <NUM> are connected to one another by lateral rods <NUM> in addition to the center rod <NUM> and one connection plate <NUM> is connected only by the center rod <NUM>. This spinal fusion implant <NUM> is different from the spinal fusion implant <NUM> shown in <FIG> in the number of connection plates <NUM> connected by the lateral rods <NUM>.

As shown in <FIG> and <FIG>, no artifact was observed in both the CT photography and the MRI photography because the spinal fusion implant <NUM> was made of a PEEK resin material. Furthermore, <FIG> and <FIG> show that the screws <NUM> are correctly punctured into the pedicles.

While in the embodiment above three or four connection plates <NUM> are used, the number of the connection plates <NUM> is not limited to three or four. The number of the connection plates <NUM> may be two, or may be five or more.

Claim 1:
A spinal fusion implant (<NUM>, <NUM>, <NUM>, <NUM>) for keeping relative positions of neighboring vertebral bodies to fall within a predetermined range, comprising:
screws (<NUM>) configured to be connected to vertebral bodies (<NUM>);
at least two connection plates (<NUM>) in each of which guide holes (3c) into which the screws (<NUM>) are inserted from a back side surface (3a) toward a belly side surface (3b) are formed at both end portions; and
a center rod (<NUM>) which connects neighboring ones of the connection plates which are configured to be fixed to the vertebral bodies (<NUM>) by the screws (<NUM>),
each of the connection plates (<NUM>) having, on the belly side surface (3b), protrusions (<NUM>) which are configured to be fitted into concave portions of intervertebral joints (<NUM>),
a center hole (3d) into which the center rod (<NUM>) is slidably inserted being formed in side surfaces of each of the connection plates (<NUM>) so that the center of the center hole is on the back side of an imaginary line (L1) which connects middle points of arc-shaped contour lines (C) of the concave portions of the neighboring intervertebral joints (<NUM>) when viewed from the head side of a human body, and
the connection plates (<NUM>) being rotatable about the center rod (<NUM>).