EP2410932A1

EP2410932A1 - Spinal dynamic stabilization device

Info

Publication number: EP2410932A1
Application number: EP09842070A
Authority: EP
Inventors: Yu Shih Weng; Ting-Hui Chiu
Original assignee: Industrial Technology Research Institute ITRI
Current assignee: Industrial Technology Research Institute ITRI
Priority date: 2009-03-27
Filing date: 2009-03-27
Publication date: 2012-02-01
Also published as: CN102448390A; WO2010108333A1; EP2410932A4

Abstract

A spinal dynamic stabilization device (10) for relieving low back pain through increasing foramen route of spine stenosis patients. Each vertebra includes a spinous process and symmetric pedicles. The spinal dynamic stabilization device (10) includes a main body (11), a foldable supporting structure (12) and a sliding bar (13). The supporting structure comprises two support portions (121, 122), when the sliding bar approaches the main body, the support portions rotatably expand toward the adjacent vertebrae of the spine.

Description

SPINAL DYNAMIC STABILIZATION DEVICE

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to a spinal dynamic stabilization device, and more particularly to a distract device which is positioned between adjacent vertebrae for relieving low back pain, sharing compression loads.

Description of the Related Art

For products of whole spine medical treatment, the spine repairing market has recently increased. In the greatest market for spine products, U.S.A., over two million people visit doctors every year because of lower back pain. Of those, about 40 percent of the patients with lower back pain, have degenerative disc disease, DDD. Because of the aging of population, the number grows up but is not be decreased. For degenerative and pathological changes of the spine, a spinal fusion surgery is clinically applied to increase stability between adjacent vertebrae and decrease pain for patients. According to a forecast , up till 2009, over 51 million people in the U.S.A. have used spinal fusion surgery to treat their degenerative and pathological spine problems. Decompression and fusion surgery are current standards for low back pain treatment. Decompression surgery not only decompress pressed nerves but preserve spinal motion in contrast to fusion technique.

However, removal of laminar can lead to lack of proper spine biomechanics which might further facilitate disc degeneration.

Even fusion is clinically recognized as gold standard, there still some concerns on spinal fusion techniques which include: (1) limited movement of adjacent vertebrae; (2) issues of adjacent level degeneration, wherein the mechanics of the spine change after the spinal fusion surgery, and pressure on intervertebral disks near the fusion area increase for increasing the index number precipitating adjacent level degeneration; and (3) incomplete fusion resulting in pseudoarthrosis and easy fractures, wherein in the worst cases, the implant cage is required to be removed.

Thus, non-fusion surgical techniques have been disclosed. Generally, the present invention emphasizes the dynamic stabilization systems for the process spacer and pedicle screw system have been developed to assist in motion preservation for solving DDD and improving axial rotation, lateral bending, flexion and extension movements of patients.

Meanwhile, with increased advances in the medical field, minimally invasive surgery has become a trend. Compared with traditional surgery, advantages of minimally invasive surgery include: smaller incisions; decreased blood loss during surgery; and decreased probability for complications. Additionally, the amount of time required for surgery and recovery time are shortened.

U.S. Patent No. 20070161992 discloses a vertebras implant device with a pair of pivoting S-shaped wings. The wings in a closed state are implanted. After implanting, the wings are expanded to maintain the height between the adjacent vertebrae. However, the device is applied by traditional surgery methods, thus, resulting incisions are relatively large.

U.S. Patent No. 2007032790 discloses a device treating stenosis with a main body and a sleeve. The main body comprises one end, and the sleeve comprises the other end. Before implant, two wings in a closed state are disposed in the sleeve. After implant, the wings are expanded.

U.S. Patent No. 2006008983 discloses a device made of PU. Before implant, the device is not filled with fluid. After implant, gas or liquid is fills the device, and the device expands as H-shaped. However, the strength and the fixture efficiency of the device have been deemed unsatisfactory. U.S. Patent No. 20070276372 discloses a surgery method and a device utilizing the same. An axle device with procedure ends is implanted via skin. After implant, one end is pushed toward one direction, and the other end is pushed toward the other end for stabling the spine.

U.S. Patent No. 20070173832 discloses MIS-based surgery method, wherein the device is expandable and implanted through MIS surgery.

U.S. Patent No. 2006008983 discloses a spine stabilization device with a supporting portion. When the supporting is implanted in the vertebra, the wings are pushed from two sides or are rotated to expand.

BRIEF SUMMARY OF THE INVENTION

The invention provides a spinal dynamic stabilization device for decompression of narrowed spacing between adjacent vertebrae, foramen routes, for example, by increasing spacing of adjacent vertebrae. Each vertebra includes a sagittal plane. The spinal dynamic stabilization device includes at least a main body and a supporting member, and further includes a guiding and engaging mechanism for either open surgery or minimally invasive surgery procedures. The device enters a closed state and packed in the tube delivery tools. The closed device is guided and transported inside delivery tube, and then opened through designed mechanism once delivered at implant site. Note that the spinal dynamic stabilization device is consist of a foldable supporting structure that can be stretched and lean against the spine. Foldable supporting structure is closed at the same direction of main body such as clam structure. The main body comprises a guiding groove. The foldable supporting structure comprises support portions, wherein the support portions pivot in relation to each other. The foldable supporting structure can also including , but not limiting to

Opening of support elements can be achieved by certain mechanisms. For example, introduction of insertion part to trigger opening of foldable supporting structure. Firstly, foldable supporting structure can be delivered to implant position, said interspinous process, and then followed by introducing insertion part. The pivoted support portions rotatably expand toward the adjacent vertebrae of the spine with control of insertion part which trigger opening of support structure. Whole system can be then positioned and stabilized between adjacent vertebrae. Delivery route can be parallel to either axial or saggital plane of spine. Support structure and insertion part further comprise slide bar and groove to guide conjugation of two elements and trigger opening of closed foldable supporting structure

The spinal dynamic stabilization device spinal dynamic stabilization device further comprises at least a guiding element to guide the insertion part and the foldable supporting structure to move in the guiding tube.

Note that the main body and the foldable supporting structure are detachable. Note that when the main body relatively moves away from the foldable supporting structure, the foldable supporting structure enters into a closed state, and when the main body relatively approaches the foldable supporting structure, the foldable supporting structure enters an open state.

Note that the main body further comprises a sensor, and the sensor is disposed on the main body for reacting to pressure.

Note that the main body further comprises a cone portion disposed on one end of the main body, and when the foldable supporting structure relatively approaches the main body, the cone portion props up the support portions. Note that the support portions are U-shaped.

Note that the support portions are H-type.

Note that the support portions are foldable and H-type

Note that the support portions are claw-type.

Note that the foldable supporting structure is a unitary structure and a foldable structure.

Note that the foldable supporting structure further comprises a pivoting portion, and the support portions are pivoted via the pivoting portion and connect to the sliding bar.

Note that the sliding bar comprises an engaging portion, the engaging portion is disposed on one end of the sliding bar, and after the sliding enter the guiding groove, the main body is fixed via the engaging portion.

Note that the main body is an asymmetric column, especially cone structure located on at least one end.

Note that the main body is a column.

Note that the main body further comprises two depressions disposed on two sides of the main body.

Note that the main body and the foldable supporting structure are metal or nonmetal material.

Note that the main body and the foldable supporting structure are metal or nonmetal material coated with a flexible material, and the flexible material comprises macromolecular compounds or a flexible metal.

Note that the main body is made of a damping material.

Note that the main body is a fillable structure, and the main body is filled with a bone cement, a physiological solution or a flexible biological polymer material.

Note that the volume of the main body is changeable after being implanted or before being implanted.

Note that the shape of the main body is changeable after being implanted or before being implanted.

Note that the spinal dynamic stabilization device further comprises a shape memory alloy disposed between the support portions.

The invention provides a spinal dynamic stabilization device comprising a main body and a foldable supporting structure. When the main body enters the adjacent vertebrae, the foldable supporting structure expands toward the adjacent vertebrae of the spine.

Note that the spinal dynamic stabilization device further comprises a guiding element to provide the main body and the foldable supporting structure to move in the guiding tube.

Note that the spinal dynamic stabilization device further comprises a expanding mechanism, sliding bar wherein the foldable supporting structure comprises support portions, and when the sliding bar approaches the main body in the guiding element, the support portions expand toward the adjacent vertebrae of the spine and reaches a steady state to accomplish an implant procedure.

Note that the foldable supporting structure is fixed on the main body. Note that the when the sliding bar relatively moves away from the main body, the support portions cover the main body.

Note that the support portions pivot in relation to each other.

Note that the sliding bar comprises a cone portion disposed on one end of the sliding bar, and when the sliding bar approaches the main body, the cone portion props up the support portions.

BRIEF DESCRIPTION OF DRAWINGS

The invention can be more fully understood by reading the subsequent detailed description and examples with references made to the accompanying drawings, wherein:

Fig. 1 is a schematic view showing a spinal dynamic stabilization device of the invention in a closed state;

Fig. 2 is a schematic view showing a spinal dynamic stabilization device of the invention in an opened state;

Fig. 3 is a schematic view showing a spinal dynamic stabilization device of the invention disposed between the adjacent vertebrae; Fig. 4 A is a schematic view showing a main body relatively moving away from a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention.

Fig. 4B is a schematic view showing a main body relatively approaching a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention;

Fig. 5A is a schematic view showing a main body relatively moving away from a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention;

Fig. 5B is a schematic view showing a main body relatively approaching a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention;

Fig. 6 is a schematic view showing another embodiment of a spinal dynamic stabilization device of the invention;

Fig. 7 is a schematic view showing another embodiment of a spinal dynamic stabilization device of the invention;

Fig. 8 is a schematic view showing a spinal dynamic stabilization device of the invention being pushed between adjacent vertebrae via a guiding tube.

The invention can be more fully understood by reading the subsequent detailed description and examples with references made to the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

Fig. 1 is a schematic view showing a spinal dynamic stabilization device of the invention in a closed state. Fig. 2 is a schematic view showing a spinal dynamic stabilization device of the invention in an opened state.

Referring to Figs. 1 and 2, a spinal dynamic stabilization device 10 comprises a main body 11, a foldable supporting structure 12 and a sliding bar 13. The main body 11 comprises a guiding groove 111, a cone portion 112 and two depressions 113 and 114. The cone portion 112 is disposed on one end of the main body 11. The depressions 113 and 114 are disposed on the upper side and a lower side of the main body 11. The foldable supporting structure 12 comprises two support portions 121 and 122, and a pivoting portion 123. The support portions 121 and 122 are pivoted in relation to each other. The sliding bar 13 comprises an engaging portion 131 disposed on one end of the sliding bar 13. The sliding bar 13 is connected to the pivoting portion 123 of the foldable supporting structure 12 and movable in the guiding groove 111.

In this embodiment, the support portions may be a clam-type, U-type or H-type support portion. The foldable supporting structure 12 is a unitary member and a foldable structure. The main body 11 is column. The clam of the support portions 121 and 122 are curved toward the main body 11. When the main body 11 is at an appropriate distance away from the foldable supporting structure 12, the foldable supporting structure 12 enters a closed state, as shown in Fig. 1. When the main body 11 approaches the foldable supporting structure 12, the foldable supporting structure 12 is propped, as shown in Fig. 2. The main body 11 further comprises flexible polymer material 115 to cover the main body 11. The main body 11 may be an asymmetric column. The main body 11 and the foldable supporting structure 12 are made of metal or nonmetal. The main body 11 is a hollow structure, and the main body 11 is filled with a bone cement, a physiological solution or a flexible biological polymer material.

Fig. 3 is a schematic view showing a spinal dynamic stabilization device of the invention disposed between the adjacent vertebrae.

Referring to Figs. 1 to 3, when the interval between the adjacent vertebrae V decreases, the spinal dynamic stabilization device 10 of the invention is implanted between the adjacent vertebrae V. The adjacent vertebrae V comprise a sagittal plane Vl, a vertebra body V2 and a soft tissue ST. The intervertebral disk D is disposed between the adjacent vertebrae body V2. The soft tissue ST is disposed between adjacent sagittal plane Vl.

Using minimally invasive surgery (or MIS), the spinal dynamic stabilization device 10 with the foldable supporting structure 12 in the closed state is installed in a endoscopic tube, and is pushed to the soft tissue ST between the adjacent sagittal plane Vl via tools. The main body 11 is pushed along an arrow A. When the main body advances, the sliding bar 13 moves in the guiding groove 111 to provide the main body 11 to approach the foldable supporting structure 12. The cone angle 112 helps the main body 11 to stably approach the foldable supporting structure 12. Thus, the support portions 121 and 122 are expanded smoothly. After expanding the support portions 121 and 122, that is, the main body 11 approaches the foldable supporting structure 12, the foldable supporting structure

12 is propped up (as shown in Figs. 2 and 3). The support portions 121 and 122 are rotatably expanded toward the sagittal plane Vl of the adjacent vertebrae V (along arrows B and C). Note that the sliding bar 13 of the spinal dynamic stabilization device 10 comprises an engaging portion 131 disposed on one end of the sliding bar 13. When the sliding bar

13 completely enters the guiding groove 111, the main body 11 is fixed via the engaging portion 131 because of the engaging portion 131 is greater in volume?? than the guiding groove 111. Installation of the depressions 113 and 114 decrease pressure on the soft tissue ST.

The spinal dynamic stabilization device 10 of the invention is applied to MIS procedures. When the spinal dynamic stabilization device 10 is implanted into the adjacent vertebrae V, the foldable supporting structure 12 is held in a closed state. When the spinal dynamic stabilization device 10 reaches the adjacent vertebrae V that are required to be propped, the main body 11 is pushed to close the foldable supporting structure 12. At this time, the support portions 121 and 122 of the foldable supporting structure expand to stretch toward the sagittal plane Vl of the adjacent vertebrae V. Thus, only a small incision is inflicted when implanting the spinal dynamic stabilization device 10 of the invention, decreasing blood lost and complications for a speedier recovery. Meanwhile, the spinal dynamic stabilization device 10 can be restored, so that a normal physiological interval between the adjacent vertebrae V is kept.

Fig. 4A is a schematic view showing a main body relatively moving away from a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention. Fig. 4B is a schematic view showing a main body relatively approaching a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention.

Referring to Figs. 4A and 4B, a spinal dynamic stabilization device 20 comprises a main body 21, a foldable supporting structure 22 and a sliding bar 23. The foldable supporting structure 22 comprises two support portions 221 and 222 and is installed on the main body 21. The support portions 221 and 222 are pivoted in relation to each other. The sliding bar 23 is installed movably between the main body and the foldable supporting structure 22. The sliding bar 23 comprises a cone angle 231 disposed on one end closer the main body 21 (shown in Fig. 4). When the sliding bar 23 relatively moves away from the main body 21, the support portions 221 and 222 cover the main body 21. When the main body 21 enters between the adjacent vertebrae V (shown in Fig. 3), the sliding bar 23 is pushed to approach the main body 21 along an arrow G. As a result, the support portions 221 and 222 are propped up smoothly, as shown in Fig. 4.

Fig. 5A is a schematic view showing a main body relatively moving away from a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention. Fig. 5B is a schematic view showing a main body relatively approaching a foldable supporting structure of another embodiment of a spinal dynamic stabilization device of the invention.

Referring to Figs. 5A and 5B, this embodiment is approximately similar to the embodiment in Fig. 1. Thus, similar descriptions are omitted for brevity. The difference however, is that the spinal dynamic stabilization device 30 further comprises a shape memory alloy 34. The shape memory alloy 34 is disposed between the support portions 321 and 322. In fig. 5, the shape memory alloy 34 is in a stretched state. When the main body 31 is pushed toward the support portions 321 and 322 along an arrow E, the support portions 321 and 322 are propped; at which time, the shape memory alloy 34 returns to an initial state. Fig. 6 is a schematic view showing another embodiment of a spinal dynamic stabilization device of the invention. Fig. 7 is a schematic view showing another embodiment of a spinal dynamic stabilization device of the invention. The embodiment in Fig. 6 is approximately similar to the embodiment in Fig. 1. Thus, similar descriptions are omitted for brevity. The difference however, is that the spinal dynamic stabilization device 40 further comprises a sensor 45a. The sensor 45a is disposed on the main body 41 to react to pressure. The embodiment in Fig. 7 is approximately similar to the embodiment in Fig. 5A. Thus, similar descriptions are omitted for brevity. The difference however, is that??? the sensor 45b is disposed on the depression 414 of the main body 41. Fig. 8 is a schematic view showing a spinal dynamic stabilization device of the invention being pushed between adjacent vertebrae via a guiding tube. Referring to Fig. 8, the spinal dynamic stabilization device 50 further comprises a guiding device 56. The guiding device 5 is a bar. One end comprises a first screw portion 561. The main body 51, the foldable supporting structure 52, and the sliding bar 53 are similar to the embodiment of Fig. 5 A. When the main body 51, the foldable supporting structure 52, and the sliding bar 53 enter a guiding tube 60, the first screw portion 561 and the second screw portion 516 are combined to provide the guiding device 56 to connect to the main body. When the spinal dynamic stabilization device 50 reaches the adjacent vertebrae V (shown in Fig. 3), the main body 51 is pushed via the guiding device 56 along an arrow F to prop up the support portions 521 and 522 for maintaining normal physiological interval between the adjacent vertebrae V.

While the invention has been described by way of example and in terms of the preferred embodiments, it is to be understood that the invention is not limited to the disclosed embodiments. To the contrary, it is intended to cover various modifications and similar arrangements (as would be apparent to those skilled in the art). Therefore, the scope of the appended claims should be accorded the broadest interpretation so as to encompass all such modifications and similar arrangements.

Claims

1. A spinal dynamic stabilization device, entering adjacent vertebrae comprising: at least a main body; and at least a foldable supporting structure; wherein when the main body enters the adjacent vertebrae, the foldable supporting structure opens rotatably toward vertebrae of the spine.

2. The spinal dynamic stabilization device as claimed in claim 1, further comprising at least a guiding element to guide the main body and the foldable supporting structure to advance in the guiding tube.

3. The spinal dynamic stabilization device as claimed in claim 2, further comprising a sliding bar, wherein the foldable supporting structure comprises support portions, and when the sliding bar approaches the main body in the guiding element, the support portions expand toward the adjacent vertebrae of the spine and reaches a steady state to accomplish an implant procedure.

4. The spinal dynamic stabilization device as claimed in claim 3, wherein when the sliding bar relatively moves away from the main body, the support portions fold closed toward the main body.

5. The spinal dynamic stabilization device claimed in claim 3, wherein the support portions pivot in relation to each other.

6. The spinal dynamic stabilization device claimed in claim 3, wherein the sliding bar comprises a cone portion disposed on one end of the sliding bar, and when the sliding bar approaches the main body, the cone portion props up the support portions.

7. A spinal dynamic stabilization device, entering adjacent vertebrae via a guiding tube to maintain the normal physiological interval between the adjacent vertebrae, wherein the adjacent vertebrae have a sagittal plane, comprising: at least a main body, comprising at least a guiding groove; at least a foldable supporting structure, comprising support portions, wherein the support portions pivot in relation to each other; and a sliding bar, connecting to the foldable supporting structure and moving in the guiding groove, wherein when the sliding bar moves in the guiding groove to provide the foldable supporting structure to approach the main body, the support portions rotatably expand toward the adjacent vertebrae of the spine.

8. The spinal dynamic stabilization device claimed in claim 7, further comprising at least a guiding element that is able to connect main body and the foldable supporting structure to advance in the guiding tube.

9. The spinal dynamic stabilization device claimed in claim 8, wherein when the sliding bar approaches the main body in the guiding element, the support portions expand toward the adjacent vertebrae of the spine and reaches a steady state to accomplish an implant procedure.

10. The spinal dynamic stabilization device claimed in claim 7, wherein the main body and the foldable supporting structure are detachable.

11. The spinal dynamic stabilization device claimed in claim 7, wherein when the main body relatively moves away from the foldable supporting structure, the foldable supporting structure enters a closed state, and when the main body relatively approaches the foldable supporting structure, the foldable supporting structure enters an open state.

12. The spinal dynamic stabilization device claimed in claim 7, wherein the main body further comprises a cone portion disposed on one end of the main body, and when the foldable supporting structure relatively approaches the main body, the cone portion props up the support portions.

13. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body is an asymmetric cylinder.

14. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body is a cylinder.

15. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body further comprises saddle on sides of the main body.

16. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body and the foldable supporting structure are made of metal, polymer or biomaterials.

17. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body and the foldable supporting structure are metal or nonmetal material coated with a flexible material, and the flexible material comprises macromolecular compounds or a flexible metal.

18. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body is a hollow structure, and the main body is filled with a bone cement, a physiological solution or a flexible biological polymer material.

19. The spinal dynamic stabilization device as claimed in claim 7, further comprising a sensor, wherein the sensor is disposed on the main body for reacting to pressure.

20. The spinal dynamic stabilization device as claimed in claim 7, wherein the support portions are claw-type.

21. The spinal dynamic stabilization device as claimed in claim 7, wherein the foldable supporting structure is a unitary structure and a foldable structure.

22. The spinal dynamic stabilization device as claimed in claim 7, wherein the support portions are U-type.

23. The spinal dynamic stabilization device as claimed in claim 7, wherein the support portions are H-type.

24. The spinal dynamic stabilization device as claimed in claim 7, wherein the foldable supporting structure further comprises a pivoting portion, and the support portions are pivoted via the pivoting portion and connect to the sliding bar.

25. The spinal dynamic stabilization device as claimed in claim 7, wherein the sliding bar comprises an engaging portion, the engaging portion is disposed on one end of the sliding bar, and after the sliding enter the guiding groove, the main body is fixed via the engaging portion.

26. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body is a column.

27. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body further comprises saddle portions disposed on an upper side and a lower side of the main body.

28. The spinal dynamic stabilization device as claimed in claim 7, wherein the main body further comprises a flexible polymer to cover the main body.

29. The spinal dynamic stabilization device as claimed in claim 7, further comprising a shape memory alloy wire disposed between the support portions.