KR102262993B1 - Expandable fusion device and intervertebral fusion system - Google Patents

Abstract

The present invention relates to an inflatable intervertebral fusion device having a contracted state and an expanded state, and an intervertebral fusion system using the same, wherein the intervertebral fusion device includes a first cage member and a second cage member coupled thereto, and at least one opening and an inner a cage having a space; and an inner member inserted into the inner space of the cage through the opening; The first cage member includes a first contact surface for contacting at least a portion of the bone and a first engagement portion for engagement with the second cage member, the first engagement portion comprising at least one inner surface of the first cage member and a concave-convex portion formed in the second cage member, wherein the second cage member includes a second contact surface for contacting at least a portion of another bone and a second coupling portion for coupling with the first cage member, wherein the second coupling portion includes the second coupling portion and an unevenness formed on at least one outer surface of the cage member, wherein the first coupling portion and the second coupling portion are coupled to each other to engage with each other, and to be movable with respect to each other.

Description

EXPANDABLE FUSION DEVICE AND INTERVERTEBRAL FUSION SYSTEM

The present invention relates to an inflatable fusion device and an intervertebral fusion system having a contracted state and an expanded state.

The vertebrae may have structural problems such as congenital, degenerative, or accidental reasons such as a problem with stable alignment or narrowing of the spacing between vertebral bodies. Representative spinal diseases include spinal deformity, vertebral fractures, disc herniation, spinal stenosis, and facet joint hypertrophy. These spinal diseases require surgical treatment when the symptoms worsen and conservative treatment becomes difficult.

Spinal fusion is one of the surgical treatment methods, after removing an intervertebral disc with spinal disease, inserting a spinal cage between the vertebral bodies to secure a space for bone growth and fusion for the vertebral body. It is a procedure that relieves pain by increasing the gap between them and maintains the stability of the spine by restoring the lordosis of the spine.

In general, an intervertebral body fusion device used in spinal fusion surgery has a hollow formed therein, a bone chip is inserted, and as the bone chip is regenerated, bone fusion occurs between the upper and lower vertebrae.

Various types of the intervertebral body fusion device have been developed depending on the treatment method, etc., and while it can be implanted in the human body, the shape for restoring the biomechanical stability of the spine is also being developed in various ways. Since the intervertebral body fusion device has to maintain a certain distance between the vertebral bodies, it is mainly formed of a biocompatible material having suitable mechanical properties and biocompatibility to support a human body load. The intervertebral body fusion device requires a process of fixing the upper and lower vertebrae so that they do not detach from the graft site until osseointegration occurs and is stabilized.

However, since the conventional intervertebral body fusion device is simply inserted between the vertebral bodies, there is a problem that the intervertebral body fusion device may slide or be separated from the treatment site if the operator moves excessively. Posterior movement was also confirmed in the TLIF (Transforaminal Lumbar Interbody Fusion) device, which has been reported to have the best fusion rate, which may lead to spinal deformity, neurological weakness, and non-union.

In addition, in order to prevent this, a form in which the fixing force is increased by forming a sawtooth on the upper or lower surface of the intervertebral body fusion device is disclosed. There is a problem that the coupling force may be loose due to the change, and the intervertebral body fusion device may still be dislodged. However, in order to insert the intervertebral body fusion device more tightly, problems such as the anatomical structure of the bones and the damage of the intervertebral body fusion device occur. Recently, as disclosed in U.S. Patent No. 8,062,375, etc. The same inflatable fusion device is widely used. The inflatable fusion device has a low height when inserted between the bones, but can be raised to a higher height after insertion, allowing tighter insertion of the intervertebral body fusion device between the vertebral bodies.

However, most of these inflatable fusion devices have a complicated internal structure, so manufacturing costs are high, and since the fusion device has to be expanded after the bone fusion material is inserted, there is a problem in that the bone fusion material cannot be completely filled therein. Accordingly, there is a demand for development of an inflatable fusion device with a simple internal structure and easy insertion of a bone fusion material.

US Patent No. 8,062,375

The present invention is to improve the problems of the prior art, and provides an inflatable intervertebral fusion device capable of inserting a bone implant after expansion of the device while having a simple internal structure and an intervertebral fusion system including the intervertebral fusion device aim to do

However, the problems to be solved by the present application are not limited to the problems mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art from the following description.

In order to achieve the above object, the present invention provides an inflatable intervertebral fusion device 1000 having a contracted state and an expanded state, wherein the first cage member 1110 and the second cage member 1120 are coupled, and at least one a cage 1100 having an opening 1101 and an interior space 1103; and an inner member (1200) inserted into the inner space (1103) of the cage through the opening (1101); The first cage member 1110 includes a first contact surface 1111 for contacting at least a portion of a bone and a first coupling portion 1113 for engagement with the second cage member 1120, wherein the first The coupling portion 1113 has an unevenness formed on at least one inner surface 1115 of the first cage member 1110, and the second cage member 1120 is a second for contacting at least a portion of another bone. a contact surface 1121 and a second coupling part 1123 for coupling with the first cage member 1110 , wherein the second coupling part 1123 is at least one outside of the second cage member 1120 . Intervertebral fusion device 1000 having irregularities formed on the surface 1125, wherein the first coupling part 1113 and the second coupling part 1123 are coupled to each other to engage with each other, and to be movable with respect to each other. ) is provided.

In addition, the present invention provides an intervertebral fusion system for inserting an inflatable intervertebral fusion device 1000 into an intervertebral space, in which a first cage member 1110 and a second cage member 1120 are coupled, and at least one opening ( 1101) and a cage 1100 having an interior space 1103, wherein the first cage member 1110 includes a first contact surface 1111 for contacting at least a portion of a bone and a second cage member 1120; and a first coupling part 1113 for coupling, wherein the first coupling part 1113 has an unevenness formed on at least one inner surface 1115 of the first cage member 1110, and the second coupling part 1113 has an unevenness formed on at least one inner surface 1115 of the first cage member 1110. The cage member 1120 includes a second contact surface 1121 for contacting at least a portion of another bone and a second coupling portion 1123 for coupling with the first cage member 1110, the second coupling portion 1123 has an unevenness formed on at least one outer surface of the second cage member 1120, and the first coupling part 1113 and the second coupling part 1123 are coupled to each other to engage each other, movable relative to the cage (1100); an inflation mechanism 2000 configured to inflate the cage 1100 by inserting it into the interior space 1103 through the opening 1101 of the cage 1100; and an inner member (1200) inserted into the inner space (1103) of the inflated cage (1100) through the opening (1101) of the cage.

The inflatable additional fusion device and the intervertebral fusion system using the inflatable additional fusion device of the present invention can tightly insert the fusion device between vertebral bodies, and have a mechanically strong structure and a simple internal structure, thereby reducing manufacturing cost. In addition, the bone graft can be easily inserted after the fusion device is expanded, and there is enough space to fill the bone fusion material, so there is no need to additionally insert the bone fusion material using a separate device after the fusion device is inserted. It provides the effect of shortening the operation time.

1A is a perspective view of an intervertebral fusion device in a contracted state according to an embodiment of the present application.
Figure 1b is a top view of the intervertebral fusion device in a contracted state according to an embodiment of the present application.
1C is a front view of the intervertebral fusion device in a contracted state according to an embodiment of the present application.
1D is a side view of an intervertebral fusion device in a contracted state according to an embodiment of the present application.
2A is a perspective view of an intervertebral fusion device in an expanded state according to an embodiment of the present application.
Figure 2b is a top view of the intervertebral fusion device in an expanded state according to an embodiment of the present application.
Figure 2c is a front view of the intervertebral fusion device in an expanded state according to an embodiment of the present application.
2D is a side view of an intervertebral fusion device in an expanded state according to an embodiment of the present disclosure;
3A is a perspective view of a cage and internal components in a retracted state according to an embodiment of the present disclosure;
3B is a perspective view of the cage and internal components in an expanded state according to an embodiment of the present disclosure;
4A is a side view of an inflation mechanism in a retracted state according to an embodiment of the present disclosure;
4B is a perspective view of an inflation mechanism in a contracted state according to an embodiment of the present disclosure;
4C is a front perspective view of an inflation mechanism and cage in a contracted state according to an embodiment of the present disclosure;
5A is a side view of an inflation mechanism in an expanded state according to an embodiment of the present disclosure;
5B is a perspective view of an inflation mechanism in an expanded state according to an embodiment of the present disclosure;
5C is a front perspective view of an inflation mechanism and cage in an expanded state according to an embodiment of the present disclosure;
6 is a cross-sectional view of an inflation mechanism in an expanded state according to an embodiment of the present disclosure;

The present invention relates to an inflatable intervertebral fusion device 1000 having a contracted state and an expanded state, and an intervertebral fusion system comprising the intervertebral fusion device.

Surgical implantation of disc replacement material is commonly used to provide support along the spine in cases where part of a person's anatomical spinal structure is weakened, diseased, or destroyed. Also, such systems are commonly used following a discectomy in which the intervertebral disc is surgically removed.

Hereinafter, embodiments of the present application will be described in detail with reference to the accompanying drawings so that those of ordinary skill in the art can easily implement them. However, the present application may be embodied in many different forms and is not limited to the embodiments described herein. And in order to clearly explain the present application in the drawings, parts irrelevant to the description are omitted, and similar reference numerals are attached to similar parts throughout the specification.

Hereinafter, the inflatable intervertebral fusion device 1000 of the present application and an intervertebral fusion system including the intervertebral fusion device will be described in detail with reference to the drawings. However, the present application is not limited to these embodiments and drawings.

The inflatable intervertebral fusion device 1000 according to the present invention includes a cage 1100 and an inner member 1200 , and has a contracted state and an expanded state.

1A to 1D and 3A show an intervertebral fusion device 1000a in a contracted state according to an embodiment of the present application, and FIGS. 2A to 2D and 3B are an intervertebral disc in an expanded state according to an embodiment of the present application. A fusion device 1000b is shown.

In the intervertebral fusion device 1000 according to the present invention, the cage 1100 includes a first cage member 1110 and a second cage member 1120 coupled thereto, and at least one opening 1101 and an internal space 1103 . It includes a cage 1100 having a. The cross-section of the cage 1100 may be rectangular, and may further include one or more openings, but is not limited thereto.

The second cage member 1120 is preferably smaller than the first cage member 1110 so that the second cage member 1120 is at least partially accommodated inside the first cage member 1110 .

The cage 1100 may be formed of a material having sufficient strength to support the vertebral body while being a biocompatible material, and is preferably formed of, for example, a titanium alloy or PEEK (polyetheretherketone).

The first cage member 1110 includes a first contact surface 1111 for contacting at least a portion of a bone and a first engagement portion 1113 for engagement with the second cage member 1120, the first coupling The portion 1113 has an unevenness formed on the at least one inner surface 1115 .

The second cage member 1120 includes a second contact surface 1121 for contacting at least a portion of another bone and a second coupling portion 1123 for engagement with the first cage member 1110, wherein the second The coupling part 1123 has irregularities formed on at least one outer surface 1125 .

A pattern may be formed on the surfaces of the first contact surface 1111 and the second contact surface 1121 to prevent the cage 1100 from sliding from the vertebral body. The shape of the pattern is not particularly limited as long as it can prevent the cage 1100 from sliding off the vertebral body.

In addition, the first coupling portion 1113 and the second coupling portion 1123 are coupled to each other, and are movable with respect to each other.

In one embodiment, the first coupling portion 1113 of the first cage member 1110 has irregularities on the first inner surface 1115a and the second inner surface 1115b that are spaced apart from each other, and the second cage member ( The second coupling portion 1123 of the 1120 has irregularities on the first outer surface 1125a and the second outer surface 1125b that are spaced apart from each other.

It is preferable that the unevenness formed in the first coupling part 1113 and the second coupling part 1123 has a tooth shape, and the inner surface 1115 of the first coupling part 1113 and the outside of the second coupling part 1123 are formed. Face 1125 has teeth at predetermined intervals.

Preferably, each tooth formed on the inner surface 1115 of the first engaging portion 1113 meshes with each tooth formed on the outer surface 1125 of the corresponding second engaging portion 1123, FIG. As shown in 2c, it is preferred that the first inner surface 1115a and the first outer surface 1125a are at least partially engaged, and the second inner surface 1115b and the second outer surface 1125b are at least partially engaged. Do.

The tooth shape as shown in FIG. 2C is relatively easy to move when a predetermined physical force is applied from the inside of the cage to the outside (in the expansion direction), and a predetermined physical force is generated from the outside of the cage to the inside (contraction direction). Since it is relatively difficult to move when applied, the cage can remain in an inflated state even after intervertebral insertion.

In one embodiment, the teeth may have a spacing of 0.2 mm to 3 mm, preferably having a spacing of 1 mm to 2 mm, may have a height of 0.1 mm to 1 mm, and may have a spacing of 0.2 mm to 0.5 mm. It is desirable to have a height. When the above range is satisfied, it is possible to provide a cage capable of well controlling expansion and contraction while appropriately reflecting anatomical differences such as the size and shape of the patient's spine.

The intervertebral fusion device 1000 of the present application includes an inner member 1200 inserted into the inner space 1103 of the cage through the opening 1101 of the cage.

The inner member 1200 is provided for each size according to the height at which the cage 1100 is expanded, and is inserted into the inner space 1103 of the cage to fix the expanded state of the cage.

Referring to FIGS. 3A and 3B , the inner member 1200a having a height that fits the inner space of the contracted state is inserted into the cage 1100a in the contracted state, and the cage 1100b in the expanded state fits the inner space of the expanded state. The inner member 1200b of a greater height is inserted to The inner member 1200 is provided with various heights at intervals of the teeth, and the inner member 1200 that is optimally suited to the expanded state is selected and inserted.

The inner member 1200 preferably includes one or more openings 1201 and an interior space 1203 for receiving the bone fusion material, and a cage 1100 for receiving the bone fusion material inside the intervertebral fusion device 1000 . ) and the inner member 1200 may further include one or more windows 1001 connected to each other. The bone fusion material may include, but is not limited to, for example, autologous bone, allograft bone, bone substitute, osteoinductive material, and/or bone cement.

The present invention also provides an intervertebral fusion system system according to the present invention. In the intervertebral fusion system according to the present invention, all of the contents described for the intervertebral fusion device according to the present invention can be applied, and detailed descriptions of overlapping parts are omitted, but the same can be applied even if the description is omitted. .

The intervertebral fusion system according to the present invention relates to a surgical method and/or a surgical instrument for inserting the inflatable intervertebral fusion device 1000 according to the present invention into an intervertebral space using an expansion device 2000 .

4A and 4B show the inflation mechanism 2000a in a contracted state, and FIGS. 5A and 5B show the inflation mechanism 2000b in an expanded state.

The inflation mechanism 2000 includes a first expandable member 2010, a second expandable member 2020, and a cylinder 2030, wherein the first expandable member 2010 and the second expandable member 2020 are each independently It is connected to the cylinder 2030 by one or more supports 2040.

The cylinder 2030 includes a first cylinder 2031 having an empty space therein; and the second cylinder 2032 having a size smaller than that of the first cylinder 2031 to be movable in the first cylinder.

In one embodiment, as shown in FIG. 6 , the expansion mechanism 2000 is configured such that the first expandable member 2010 is connected to a first cylinder 2031 and a second cylinder 2032 by one or more supports 2041a, 2041b. respectively, and the second expandable member 2020 is preferably connected to the first cylinder 2031 and the second cylinder 2032 by one or more supports 2042a and 2042b, respectively.

Further, in one embodiment, the expansion mechanism 2000 includes a support 2041a connecting the first expandable member 2010 and the first cylinder 2031 and the second expandable member 2020 and the first cylinder 2031 . The connecting support 2042a includes a first coupling part A connected to each other at a predetermined angle, and the support 2041b and the second expansion member connecting the first expandable member 2010 and the second cylinder 2032 to each other. It is preferable that the support 2042b connecting the member 2020 and the second cylinder 2032 includes a second coupling portion B connected to each other at a predetermined angle.

For example, referring to FIG. 6 , when the expansion mechanism 2000 enters the expanded state from the contracted state, the distance between the first coupling part A and the second coupling part B becomes closer, and the angle between the supports becomes larger, and accordingly, the first expandable member 2010 and the second expandable member 2020 are spaced apart from each other by a predetermined interval.

In the intervertebral fusion system according to the present invention, as shown in FIG. 4C , the cage 1100a in a contracted state is inserted into the intervertebral column while a part of the expansion mechanism 2000a is inserted into the internal space through the opening of the cage. In this case, the first expandable member and the second expandable member of the expansion mechanism may be in contact with each other (contracted state).

Then, as shown in Fig. 5c, by expanding the inflation mechanism 2000b inserted into the intervertebral column, a physical force is applied to the first cage member 1110 and the second cage member 1120 to selectively size the cage ( 1100b) can be extended.

In one embodiment, the expansion of the expansion mechanism 2000 is as horizontally spaced apart from each other after the first expandable member 2010 and the second expandable member 2020 are inserted into the inner space of the cage 1100a in a contracted state, As the distance between the first expandable member 2010 and the second expandable member 2020 increases, a physical force is applied to each of the first and second cage members 1110 and 1120 to expand the cage 1100b. make it

For example, when the operator applies a physical force to the first cylinder 2031 in the insertion direction while the position of the cage into which the expansion mechanism 2000 is inserted is fixed, the first expandable member and the second expandable member are in contact with each other may be spaced apart from each other by a predetermined distance.

In addition, after removing the expansion mechanism 2000b from the cage 1100b in the expanded state, the inner member 1200 filled with the bone fusion material in advance is inserted into the inner space of the cage to fix the expanded state of the cage.

In this case, the inner member 1200 is provided for each size according to the height at which the cage is expanded, and an inner member 1200 having a suitable size may be selectively inserted according to the expansion height of the inner space of the cage.

1000: intervertebral fusion device 1100: cage
1110: first cage member 1120: second cage member
1200: inner member 2000: inflation mechanism
2010: first expandable member 2020: second expandable member
2030: cylinder

Claims (15)

An inflatable intervertebral fusion device having a contracted state and an expanded state, the device comprising:
a cage to which the first cage member and the second cage member are coupled, the cage having at least one opening and an inner space; and
an inner member inserted into the inner space of the cage through the opening to fix the expanded state of the cage;
The first cage member includes a first contact surface for contacting at least a portion of the superior vertebral body and a first engagement portion for engagement with the second cage member, the first engagement portion comprising at least one of the first cage members. Located on the inner surface, the inner surface has a first inner surface and a second inner surface that are spaced apart from each other and provided with irregularities formed on the inner surface,
The second cage member includes a second contact surface for contacting at least a portion of a lower vertebral body and a second engagement portion for engagement with the first cage member, the second engagement portion comprising at least one exterior of the second cage member Located on the surface, the outer surface has a first outer surface and a second outer surface that are spaced apart from each other and provided with irregularities formed on the surface,
The first coupling portion and the second coupling portion are coupled to each other and are movable with respect to each other,
wherein the inner member includes one or more openings and an interior space for receiving the bone fusion material, and wherein the cage and the upper and side surfaces of the inner member further include one or more windows connected to each other for receiving the bone fusion material. Characterized in the intervertebral fusion device.
delete The method according to claim 1,
The unevenness is in the form of a gear, and the inner surface of the first coupling part and the outer surface of the second coupling part have teeth at predetermined intervals, and each tooth formed on the inner surface of the first coupling part corresponds to the second coupling part. An intervertebral fusion device, characterized in that it meshes with each tooth formed on the outer surface of the part.
The method according to claim 1,
wherein the second cage member is smaller than the first cage member such that the second cage member is at least partially housed within the first cage member.
delete delete delete An intervertebral fusion system for inserting an inflatable intervertebral fusion device into an intervertebral space, comprising:
A cage having a first cage member and a second cage member coupled thereto, the cage having at least one opening and an interior space, the first cage member having a first contact surface for contacting at least a portion of a superior vertebral body and the second cage member and a first coupling part for coupling with, wherein the first coupling part is located on at least one inner surface of the first cage member, and the inner surface has irregularities formed on the first inner surface and the second inner surface spaced apart from each other. wherein the second cage member includes a second contact surface for contacting at least a portion of the lower vertebral body and a second coupling portion for engagement with the first cage member, the second coupling portion of the second cage member It is located on at least one outer surface, the outer surface has a first outer surface and a second outer surface that are spaced apart from each other and provided with unevenness, the first coupling part and the second coupling part are coupled to each other and engaged with each other, movable with respect to the cage;
an inflation mechanism configured to be inserted into the interior space of the cage to inflate the cage; and
An inner member inserted into the inner space of the inflated cage through the opening of the cage to fix the inflated state of the cage, the inner member including one or more openings and an inner space for accommodating a bone fusion material; wherein the cage and the inner member further comprise one or more windows connected to each other for receiving the bone fusion material.
9. The method of claim 8,
wherein the expansion mechanism comprises a first expandable member, a second expandable member, and a cylinder, wherein the first expandable member and the second expandable member are each independently connected to the cylinder by at least one support; Intervertebral fusion system.
10. The method of claim 9,
The cylinder may include a first cylinder having an empty space therein; and a second cylinder having a smaller size than the first cylinder to be movable within the first cylinder.
11. The method of claim 10,
wherein the first expandable member and the second expandable member are each independently connected to the first cylinder and the second cylinder by one or more supports.
10. The method of claim 9,
and the first expandable member and the second expandable member are horizontally spaced apart from each other after being inserted into the interior space of the cage to move the first cage member and the second cage member.
9. The method of claim 8,
The irregularities are teeth-shaped, and have teeth at predetermined intervals, and each of the teeth formed on the first inner surface and the second inner surface is formed on the corresponding first outer surface and the second outer surface. Intervertebral fusion system, characterized in that they engage each other.
delete 9. The method of claim 8,
The inner member is an intervertebral fusion system, characterized in that provided for each size according to the height at which the cage is expanded.

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