WO2007145420A1

WO2007145420A1 - Spacer for use in a surgical operation for spinous process of spine.

Info

Publication number: WO2007145420A1
Application number: PCT/KR2007/001415
Authority: WO
Inventors: Shin Goo Hur; Yeon Ho Kim; Jun Ho Song; Nam Gu Kim
Original assignee: Bio-Smart Co., Ltd
Priority date: 2006-06-12
Filing date: 2007-03-22
Publication date: 2007-12-21
Also published as: KR100811210B1; KR20070118344A

Abstract

A spacer used for securing a space between spinous processes of a spine is provided. The spacer includes: a pair of supporting parts for supporting a pair of the spinous processes; and a connecting part for connecting the pair of the supporting parts to each other, which is made of a shape memory alloy and transformed in a direction in which the pair of the supporting parts are spaced apart from each other due to a body temperature, thereby providing expansive force for allowing the supporting parts to support the spinous processes. Accordingly, a surgical operation is more simplified. It is possible to maintain a space between the spinous processes by incising a minimized area. Thus, a damage applied to the spine can be minimized.

Description

SPACER FOR USE IN A SURGICAL OPERATION FOR SPINOUS PROCESS OF SPINE

Technical Field

[1] The present invention relates to a spine fixing instrument inserted between spinous processes of a spine, and more particularly, to a spacer which is inserted between spinous processes to fix a spine by constantly securing a space between spinous processes through a feature of shape memory alloy. Background Art

[2] A spine fixing instrument is a medical instrument used for orthopedics or neurosurgery so as to correct a spine or fix a damaged part. A spine fixing instrument constructed with a pair of screws fixed to a spine and a rod for connecting both screws to each other has been widely used.

[3] The spine fixing instrument with the aforementioned structure is used in a method in which by driving a screw after drilling into both sides of the corresponding area, in a state a broken area or deformed area of a spine disk (scoliosis, kyphosis, and etc.) is incised and a wrong spine arrangement is corrected

[4] Accordingly, when using the conventional spine fixing instrument, since a surgical operation is too complex, it takes too long time to perform a surgical operation by using the conventional spine fixing instrument. In addition, it is difficult to suitably adjust a degree of tightness between screws by using a rod. There is a problem that many damages occur in a spine when performing the surgical operation. Disclosure of Invention Technical Problem

[5] The present invention provides a spacer, which is inserted between spinous processes of a spine, capable of preventing a spine bone from being damaged, simplifying a surgical operation, and reducing a surgical operation time by fixing a space between the spinous processes of the spine by using a shape memory alloy that is transformed due to a body temperature.

[6] The present invention also provides a spacer, which is inserted between spinous processes of a spine, having a structure capable of preventing the spacer from being separated from the spinous processes due to floating of the spine in left and right directions and in forward and backward directions. Technical Solution

[7] According to an aspect of the present invention, there is provided a spacer which is inserted between spinous processes of a spine, the spacer comprising: a pair of supporting parts for supporting a pair of the spinous processes; and a connecting part for connecting the pair of the supporting parts to each other, which is made of a shape memory alloy and transformed in a direction in which the pair of the supporting parts are spaced apart from each other due to a body temperature, thereby providing expansive force for supporting the spinous processes.

[8] In the above aspect of the present invention, the supporting parts may be integrated into the connecting part by using the shape memory alloy.

[9] In addition, the supporting parts may be transformed due to the body temperature to construct notch structures into which the spinous processes are inserted.

[10] In addition, the connecting part may be transformed from an oval shape to a circular shape due to the body temperature. The pair of the supporting parts may be constructed with a wire, strip or plate with a predetermined length of which a central part is connected to upper and lower ends of the connecting part and horizontally laid, and both sides of each supporting part may be transformed to be bended to a vertical direction with respect to the central part so as to form the notch structure.

[11] In addition, the pair of the supporting parts may be transformed due to the body temperature to construct notch structures into which the spinous processes are inserted.

[12] In addition, the supporting parts may be constructed with a bended wire, strip, or plate so as to form the notch structures at a central portion of the supporting part. The connecting part may be constructed with a wire, strip, or plate with a round shape, which connects both central parts of the pair of the supporting parts to each other.

[13] Alternatively, the supporting parts may be constructed with a bended wire, strip, or plate so as to form the notch structures. The connecting part may be constructed with a wire, strip, or plate with a round shape which connects the pair of the supporting parts to each other.

[14] In addition, the spacer which is inserted between the spinous processes may further include a curve part which extends from the supporting parts so as to hook up the spinous processes. Brief Description of the Drawings

[15] The attached drawings for illustrating exemplary embodiments of the present invention are referred to in order to gain a sufficient understanding of the present invention. The invention should not be construed as being limited to the description on the drawings.

[16] FIG. 1 is a perspective view illustrating a spacer which is inserted between spinous processes according to a first embodiment of the present invention.

[17] FIG. 2 illustrates a changed state of the spacer which is inserted between spinous processes of FIG. 1 according to a body temperature. [18] FIG. 3 is a perspective view illustrating a spacer which is inserted between spinous processes of FIG. 1.

[19] FIG. 4 is a perspective view illustrating a spacer which is inserted between spinous processes according to a second embodiment of the present invention.

[20] FIG. 5 illustrates a changed state of the spacer which is inserted between spinous processes of FIG. 4 according to a body temperature.

[21] FIG. 6 is a perspective view illustrating a state in which the spacer of FIG. 4 is inserted between spinous processes.

[22] FIG. 7 is a perspective view illustrating a spacer which is inserted between spinous processes according to a second embodiment of the present invention.

[23] FIG. 8 illustrates a changed state of the space which is inserted between spinous processes of FIG. 7 according to a body temperature.

[24] FIG. 9 is a perspective view illustrating a state in which the space of FIG. 7 is inserted between spinous processes.

[25] <Reference numerals>

[26] 10: spinous process 100, 103, 106: connecting part

[27] 101, 104, 107: supporting parlO2, 105, 108: notch structure

[28] 109: curve part

Best Mode for Carrying Out the Invention

[29] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings. Meaning of terminology used herein should be determined in consideration of functionality of the present invention, and it may be variable depending on user's or operator's intention, or customs in the art. Therefore, corresponding meaning should be determined with reference to the entire pages of the specification. The exemplary embodiments should be considered in descriptive sense only and not for purposes of limitation. Therefore, the scope of the invention is defined not by the detailed description of the invention but by the appended claims, and all differences within the scope will be construed as being included in the present invention.

[30] FIG. 1 is a perspective view illustrating a shape memory state of a spacer which is inserted between spinous processes according to a first embodiment of the present invention.

[31] Referring to FIG. 1, the spacer which is inserted between spinous processes according to the first embodiment of the present invention is made of a shape memory alloy. The spacer includes a body constructed with a pair of supporting parts 101 for supporting the spinous processes of a spine and a connecting part 100 for connecting the pair to the supporting parts 101 to each other, which provides expansive force to the supporting parts 101.

[32] The supporting parts 101 serve to provide supporting planes for supporting spinous processes between which the spacer is inserted. A pair of supporting parts 101 are prepared in correspondence with the pair of the spinous processes.

[33] The supporting parts 101 provide reentrant notch structures 102 into which the spinous processes are inserted. In the current embodiment, the notch structures 102 are provided through a transformation process of the shape memory alloy after inserting the spacer between the spinous processes.

[34] The notch structures 102 of the supporting parts 101 serves to prevent the spacer body from floating from the spinous processes after inserting the spacer between the spinous processes. The notch structures 102 are not limited to a U-shape shown in FIG. 1. Since the notch structures 102 have only to provide regions in which the spinous processes are held, the notch structures 102 may have various shapes such as a V- shape.

[35] The connecting part 100 connects the pair of the supporting parts 101 to each other.

The connecting part 100 is transformed in a direction in which the pair of the supporting parts are spaced apart from each other due to a body temperature, thereby providing expansive force for allowing the supporting parts 101 to support the spinous processes. For this function, the connecting part 100 is made of a shape memory alloy. Preferably, the supporting parts 101 and the connecting part 100 are integrated into a single body. In this case, the connecting part 100 and the supporting parts 101 are made of the shape memory alloy. Hereinafter, a structure in which the supporting parts 101 and the connecting part 100 which constitute the spacer are integrated into a single body by using the shape memory alloy will be described.

[36] The shape memory alloy may be an alloy of which a main ingredient is a titanium nickel (TiNi) alloy. The shape memory alloy is not limited thereto.

[37] In a shape memory process, a wire or strip made of the shape memory alloy is fabricated to a shape, which is to be maintained after insertion of the spacer, and fixed so as not to be deformed during a heat treatment process. Then, the shape memory heat treatment is applied to the wire or strip in a temperature range between about 300 degrees Celsius and 900 degrees of Celsius for more than ten minutes.

[38] Selectively, in the shape memory process, a plate with a predetermined length and a predetermined thickness is fabricated to a shape to be maintained after insertion of the spacer by using a cutting machine. Then, the shape memory heat treatment is applied to the plate in a temperature range between about 300 degrees Celsius and 900 degrees of Celsius for more than ten minutes.

[39] Selectively, in the shape memory process, in a state that a wire, strip, or plate is bound in a jig corresponding to a shape to be maintained after insertion of the spacer, the shape memory heat treatment may be applied to the wire, strip, or plate in a temperature range between about 300 degrees Celsius and 700 degrees of Celsius for more than ten minutes.

[40] In the aforementioned shape memory process, the shape memory process is applied to the connecting part 100 of the spacer according to the first embodiment of the present invention so that the connecting part 100 has a transformable structure in which the shape of the connecting part 100 is transformed from an oval shape to a circular shape through the shape memory process due to a body temperature. The shape memory process is applied to the pair of the supporting parts 101 so that central portions of the pair of the supporting parts 101 are respectively connected to upper and lower ends of the connecting part 100 and horizontally laid and so that both sides of each supporting part are transformed to be bended to a vertical direction with respect to the central portions so as to form the notch structures 102.

[41] As shown in FIG. 2A, the spacer is inserted in a state that the connecting part 100 is shrunk so that the spacer has a height less than the distance between the spinous processes between which the spacer is inserted, in a martensite state in a temperature lower than about 25 degrees Celsius that is the transformation temperature of the spacer.

[42] When about one to two minutes are elapsed after insertion of the spacer, the temperature of the spacer body increases due to the body temperature. When the spacer body temperature is equal to or greater than the transformation temperature, as shown in FIG. 2B, the connecting part 100 and the supporting parts 101 of the spacer are restored to a state before shrinking and expanded (refer to dotted arrows). Specifically, the supporting parts 101 are transformed so that both ends of each supporting part 101 are bended in a vertical direction with reference to the central portion of each supporting part 101 to form notch structures 102, thereby supporting the spinous processes.

[43] FIG. 3 illustrates a state in which a spacer is inserted between a pair of spinous processes 10. As shown in FIG. 3, the spacer fixes the space between the spinous processes 10 by extending the connecting part 100 and the supporting parts 101. The spinous processes 10 are respectively inserted into the notch structures 102 to prevent the spacer from being separated from the spinous processes, when the spine floats.

[44] FIG. 4 is a perspective view illustrating a shape memory state of a spacer which is inserted between spinous processes according to a second embodiment of the present invention. Although the spacer which is inserted between the spinous processes according to the second embodiment of the present invention is manufactured through the same shape memory process as the first embodiment, the spacer includes supporting parts 104 and connecting parts 103 with different structures from the first embodiment.

[45] Referring to FIG. 4, the spacer which is inserted between spinous processes according to the second embodiment of the present invention includes a body constructed with a pair of the supporting parts 104 in which notch structures 105 for supporting the spinous processes of a spine are prepared and a connecting part 103 for connecting the pair of the supporting parts 104 to each other, which provides expansive force to the supporting parts 104. Here, the notch structures of the supporting parts 104 are always provided regardless of the transformation process of the shape memory alloy.

[46] More specifically, the supporting parts 104 are constructed with a bended wire, strip, or plate so as to form the notch structures 105 into which the spinous processes are inserted at central portions of the supporting parts. The connecting part 103 is constructed with a wire, strip, or plate with a round shape which connects central parts of the pair of the supporting parts to each other.

[47] As described above, the shape of the connecting part 103 of the spacer according to the second embodiment of the present invention is transformed from a substantial oval shape to a circular shape through the shape memory process due to a body temperature. The width of the pair of the supporting parts 104 are transformed from a narrow width to a wide width through the shape memory process.

[48] As shown in FIG. 5A, the spacer is inserted in a state that the connecting part 103 is shrunk so that a distance between the notch structures 105 of the pair of the supporting parts 104 is less than that between the spinous processes between which the spacer is inserted, in a martensite state in a temperature lower than about 25 degrees Celsius that is the transformation temperature of the spacer.

[49] When about one to two minutes are elapsed after insertion of the spacer, the temperature of the spacer body increases due to the body temperature. When the spacer body temperature is equal to or greater than the transformation temperature, as shown in FIG. 5B, the connecting part 103 and the supporting parts 104 of the spacer are restored to a state before shrinking and expanded (refer to dotted arrows). Specifically, the spacer is transformed so that the distance between the pair of the supporting parts 104 is increased and so that the width of the notch structures 105 is decreased, thereby supporting the spinous processes of the spine.

[50] FIG. 6 illustrates a state in which a spacer is inserted between a pair of spinous processes 10. As shown in FIG. 6, the spacer fixes the distance between the spinous processes 10 by allowing the connecting part 103 and the supporting parts 104 of the spacer to be expanded due to the body temperature. The spinous processes 10 are hooked up into the notch structures 105, and the spacer is prevented from being separated from the spinous processes 10, when the spine floats. [51] FIG. 7 is a perspective view illustrating a shape memory state of a spacer which is inserted between spinous processes according to a third embodiment of the present invention. Although the spacer which is inserted between the spinous processes according to the third embodiment of the present invention is manufactured through the same shape memory process as the aforementioned first and second embodiments, the spacer according to the third embodiment includes supporting parts 107 and a connecting part 106 with different structures from the first and second embodiment.

[52] Referring to FIG. 7, the spacer which is inserted between the spinous processes according to the third embodiment of the present invention includes a body constructed with a pair of supporting parts 107, in which notch structures 108 for supporting the spinous processes of a spine are prepared, and a connecting part 106, which connects the pair of the supporting parts 107 to each other, and provides expansive force to the supporting parts 107 when the spacer is transformed. Here, the notch structures 108 of the supporting parts 107 are always provided regardless of a transformation process of a shape memory alloy.

[53] The supporting parts 107 are constructed with a bended wire, strip, or plate to form the notch structures 108 into which the spinous processes are inserted. The connecting part 106 is constructed with a wire, strip, or plate with a round shape which connects the pair of the supporting parts 107 to each other.

[54] The supporting part 107 may include curve parts 109 to hook up the spinous processes in a side opposite to the part extended to the connecting part 106.

[55] As described above, the connecting part 106 according to the third embodiment of the present invention is transformed from a substantial oval shape to a circular shape through the shape memory process due to a body temperature. The curve parts extended from the supporting parts 107 are transformed into hook shapes to hook up the spinous processes through the shape memory process.

[56] As shown in FIG. 8A, the spacer is inserted in a stat that the connecting parts 106 is shrunk so that a distance between the notch structures 108 of the pair of the supporting parts 107 is less than that between the spinous processes between which the spacer is inserted, in a martensite state in a temperature lower than about 25 degrees Celsius that is the transformation temperature of the spacer.

[57] When about one to two minutes are elapsed after insertion of the spacer, the temperature of the spacer body increases due to the body temperature. When the spacer body temperature is equal to or greater than the transformation temperature, as shown in FIG. 8B, the connecting part 106 and the supporting parts 107 of the spacer are restored to a state before shrinking and expanded (refer to dotted arrows). Specifically, the spacer is transformed so that the distance between the pair of the supporting parts 107 is increased, thereby supporting the spinous processes and so that the curve parts 109 hook up the spinous processes, thereby more stably fixing the spacer body.

[58] FIG. 9 illustrates a state in which a spacer is inserted a pair of spinous processes 10.

As shown in FIG. 9, the spacer fixes the distance between the spinous processes 10 by allowing the connecting part 106 and the supporting parts 107 of the spacer to be expanded due to the body temperature. The spinous processes 10 are hooked up into the notch structures 108, and the space is prevented from being separated from the spinous processes 10, when the spine floats.

[59] While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present invention as defined by the appended claims. Industrial Applicability

[60] According to the present invention, since a spine is less damaged when a spacer is inserted into spinous processes of the spine, it is possible to rapidly recover a function of the spine. When the spacer has only to be located between the spinous processes, since the spacer is expanded due to a body temperature within about one or two minutes, the space is stably fixed. Accordingly, a surgical operation is simple. Thus, it is possible to reduce a surgical operation time.

[61] Specifically, since the spacer can be prevented from being separated from the spinous processes by allowing the spinous processes to be inserted into the notch structures when the spine floats in left and right directions and in forward and backward directions, it is possible to stably maintain the inserted state.

[62] In addition, since it is possible to insert the large sized spacer into the spinous processes by shrinking the spacer and inserting the spacer into the spinous process through an endoscope tube or a tube with a small size aperture, it is possible to reduce an area to be incised as compared with a conventional technique.

Claims

[1] A spacer which is inserted between spinous processes of a spine, the spacer comprising: a pair of supporting parts for supporting a pair of the spinous processes; and a connecting part for connecting the pair of the supporting parts to each other, which is made of a shape memory alloy and transformed in a direction in which the pair of the supporting parts are spaced apart from each other due to a body temperature, thereby providing expansive force for allowing the supporting parts to support the spinous processes.

[2] The spacer according to claim 1, wherein the supporting parts are integrated into the connecting part by using the shape memory alloy.

[3] The spacer according to claim 2, wherein the supporting parts are transformed due to the body temperature to construct notch structures into which the spinous processes are inserted.

[4] The spacer according to claim 3, wherein the connecting part is transformed from an oval shape to a circular shape due to the body temperature, and wherein the pair of the supporting parts are constructed with a wire, strip or plate with a predetermined length of which a central part is connected to upper and lower ends of the connecting part and horizontally laid, and both sides of each supporting part are transformed to be bended to a vertical direction with respect to the central part so as to form the notch structure.

[5] The spacer according to claim 1 or 2, wherein the pair of the supporting parts are transformed due to the body temperature to construct notch structures into which the spinous processes are inserted.

[6] The spacer according to claim 5, wherein the supporting parts are constructed with a bended wire, strip, or plate so as to form the notch structures at central portions of the supporting parts, and wherein the connecting part is constructed with a wire, strip, or plate with a round shape, which connects both central parts of the pair of the supporting parts to each other.

[7] The spacer according to claim 5, wherein the supporting parts are constructed with a bended wire, strip, or plate so as to form the notch structures, and wherein the connecting part is constructed with a wire, strip, or plate with a round shape which connects the pair of the supporting parts to each other.

[8] The spacer according to claim 7, further comprising a curve part which extends from the supporting parts so as to hook up the spinous processes.