Balloon dilation catheter
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a balloon dilation catheter.
Background
The balloon dilation catheter can be used as a medical intervention instrument for dilating a narrow cavity organ in a human body under the influence of guidance, such as treating thrombus blockage in peripheral blood vessels, dredging blood vessels, dilating blood vessel channels, and widening the cavity pipelines in the human body such as sinuses, intestines and stomach, urethra and the like. The balloon dilation catheter is a soft catheter with an inflatable balloon at the head end, and can be retracted after successful treatment to withdraw the balloon catheter outside the body under the condition that the balloon catheter enters the target lesion. The most common on the market at present is a liquid filled balloon dilation catheter, which performs balloon dilation by inputting liquid into a balloon, wherein the liquid can be a mixed liquid of sterile injection and contrast liquid. The liquid filled balloon dilation catheter is widely applied in the interventional vasodilation field. However, in some application situations, the liquid-filled balloon has the problems of poor stability after expansion and incapability of flexibly adjusting the expansion degree and the form after expansion at any time, so that the dredging or expansion effect is not ideal.
Disclosure of Invention
The invention aims to provide a balloon dilation catheter which has good stability after balloon dilation and can flexibly adjust the degree of balloon dilation.
In order to achieve the above purpose, the invention adopts the following technical scheme:
A balloon dilation catheter comprising an operating handle; a catheter having a first lumen for passage of a guidewire and a second lumen for passage of a gas or liquid, the operating handle being disposed at a proximal end of the catheter; the balloon framework can be radially expanded or contracted, the balloon framework is axially sleeved on the periphery of the far end of the catheter, the near end of the balloon framework and the far end of the balloon framework can respectively slide along the axial direction of the catheter, the compliance of the balloon framework is less than or equal to 5 percent, the balloon framework is axially clamped and sleeved outside the balloon framework, the cross section of the balloon framework is C-shaped, the balloon framework is provided with a balloon filling pipeline for communicating the inside of the balloon framework and the second cavity, the clamping assembly is arranged between the balloon framework and used for connecting the balloon framework and the balloon framework, a first adjusting piece is fixedly connected with the far end of the balloon framework and is in sliding connection with the near end of the balloon framework, a second adjusting piece is fixedly connected with the near end of the balloon framework, an adjusting locking mechanism can adjust and lock the balloon framework, the position between the balloon framework and the near end of the balloon framework is enlarged along with the radial direction of the balloon framework, the distance between the second adjusting piece and the near end of the balloon framework is enlarged along with the radial direction or the far end of the balloon framework is enlarged along with the radial direction of the second adjusting piece, the distance between the near end of the balloon framework is enlarged along with the near end of the balloon framework or the near end is enlarged along with the radial direction of the near end of the balloon framework or the near end of the balloon framework is enlarged, the radial direction of the sacculus skeleton is contracted along with the sacculus skeleton, and then the C-shaped opening of the sacculus body is contracted along with the sacculus skeleton, and the radial direction of the sacculus body is contracted along with the sacculus body.
Preferably, a filling port is formed in a side wall, close to the balloon skeleton, of the balloon body, one end of the balloon body filling pipeline is communicated with the filling port, the other end of the balloon body filling pipeline penetrates through the balloon skeleton and is communicated with the second cavity, and reserved folds are formed in the balloon body filling pipeline. The design of reserved folds enables the balloon body filling pipeline to have a pulling allowance when the C-shaped balloon expands radially.
Preferably, the clamping assembly comprises a guide rail fixedly arranged on the side wall of the balloon body, which is close to the balloon skeleton, along the axial direction, and a sliding block fixedly arranged on the balloon skeleton and capable of being in sliding connection with the guide rail.
Further preferably, the slider comprises a plurality of axially spaced apart sliders.
Further preferably, the guide rail is made of stainless steel, for example 304 stainless steel.
Further preferably, the guide rail is provided with a groove-shaped slideway, the sliding block is positioned in the groove-shaped slideway, and the groove-shaped slideway is made of a developable polymer material. For example, the material of the groove-shaped slideway can be a silicon rubber material added with contrast agents such as iodine or barium, so that the groove-shaped slideway has good developing effect under rays, excellent biocompatibility and flexibility, and good sliding effect in the balloon skeleton deformation process.
According to a specific and preferred embodiment, the guide rail comprises a first guide rail and a second guide rail, the first guide rail extends from the distal end of the capsule to the middle of the capsule, the second guide rail extends along the proximal end of the capsule to the middle of the capsule, a distance exists between the proximal end of the first guide rail and the distal end of the second guide rail, and the slide block comprises a slide block capable of being slidingly connected with the first guide rail and a slide block capable of being slidingly connected with the second guide rail.
Further, a basket is arranged between the clamping assembly and the guide pipe, the basket is of a hollow structure with two open ends, two sides of one end of the basket being open are respectively fixedly connected with the proximal end of the first guide rail and the distal end of the second guide rail, the other end of the basket is open and fixedly connected with the guide pipe, and the capsule filling pipeline is arranged in the basket in a penetrating mode.
Still further, the bladder filling duct is funnel-shaped with an opening and the opening is in communication with the filling opening.
Further, the basket is funnel-shaped with an opening and the opening is connected with the first guide rail and the second guide rail.
Further, the basket is made of flexible materials, such as silica gel.
According to a specific and preferred embodiment, the first adjusting member is of a hollow tubular structure and is axially slidably sleeved on the catheter, the balloon skeleton is axially sleeved outside the first adjusting member, the distal end of the balloon skeleton is fixedly connected with the distal end of the first adjusting member, a strip-shaped groove extending along the axial direction is formed in the portion, located in the balloon skeleton, of the first adjusting member, the balloon filling pipeline penetrates through the balloon skeleton and the strip-shaped groove to be communicated with the second cavity, the second adjusting member is of a hollow tubular structure and is axially slidably sleeved on the first adjusting member, and the distal end of the second adjusting member is fixedly connected with the proximal end of the balloon skeleton.
Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting piece, a second matching part arranged on the second adjusting piece, and a third matching part arranged on the operating handle and capable of being respectively matched with the first matching part and the second matching part.
Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting piece, a second matching part arranged on the second adjusting piece, and a third matching part arranged on the operating handle and capable of being respectively matched with the first matching part and the second matching part.
According to some specific and preferred embodiments, the operating handle is provided with a containing cavity, the first adjusting member and the second adjusting member respectively extend into the containing cavity, the first matching part is a first external thread formed on the outer side wall of the proximal end of the first adjusting member, the second matching part is a second external thread formed on the outer side wall of the proximal end of the second adjusting member, the spiral directions of the first external thread and the second external thread are opposite, the pitch of the first external thread and the pitch of the second external thread are the same or different, the third matching part comprises a dial wheel and a transmission member, the dial wheel is rotatably arranged on the operating handle in the containing cavity in a part of the dial wheel around the self axis direction, the transmission member is rotatably arranged in the containing cavity around the self axis direction, the transmission member is axially sleeved on the second adjusting member, the inner side wall of the proximal end of the transmission member is provided with a first internal thread, the transmission member is rotatably arranged on the inner side wall of the proximal end of the transmission member in the second adjusting member, when the first external thread and the second external thread is in the second direction, the second matching part of the transmission member is rotatably arranged on the second adjusting member around the second external thread around the self axis direction, the second external thread is rotatably connected with the second external thread around the second external thread, and the second external thread is further connected with the second external thread around the second external thread, and the second external thread is in the second direction, and the second external thread is meshed with the dial wheel in the second direction, and the second external thread when the second external thread is rotatably around the second external thread and rotates part and the second external thread and rotates around the second external thread and the second member, the driving wheel drives the transmission piece to rotate around the axis direction of the driving wheel along a fourth direction, so that the first adjusting piece is driven to move towards the far end and the second adjusting piece is driven to move towards the near end, one of the first direction and the second direction is clockwise, the other is anticlockwise, one of the third direction and the fourth direction is clockwise, and the other is anticlockwise.
Preferably, the balloon skeleton is provided with a plurality of mesh structures which are sequentially connected along the axial direction and the circumferential direction.
Preferably, the distal end of the balloon skeleton is provided with a radially non-variable first ring, and the proximal end of the balloon skeleton is provided with a radially non-variable second ring.
Preferably, the balloon skeleton is woven from wires or cut from hollow tubes.
Preferably, the outer surfaces of the balloon body and the balloon filling channel are covered with a braiding layer, so that the compliance of the balloon body can be further reduced.
Preferably, the balloon is integrally formed with the balloon inflation channel.
Preferably, the outer surface of the capsule is coated with a hydrophilic coating.
Preferably, the material of the capsule body is a polymer material.
Preferably, the balloon skeleton is made of a developable polymer material.
According to some embodiments, the operating handle is provided with a first inlet and a second inlet which are communicated with the first cavity and the second cavity.
Preferably, the balloon dilation catheter further comprises a catheter sheath sleeved outside the catheter and the balloon body. The balloon dilation catheter of the present invention is suitable for use with conventional sized sheaths, preferably 3-8F inner diameter sheaths. The actual application is selected according to the size of the lesion body pipeline.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
The balloon dilation catheter has better stability after balloon dilation, and can flexibly adjust the balloon dilation degree so as to improve dredging and dilation effects. The balloon dilation catheter can be held by one hand and operated by thumb, and is convenient, quick and flexible.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view showing the structure of a balloon dilation catheter of example 1 in a balloon radially-expanded state;
FIG. 2 is a schematic view (partially cut-away) of the balloon dilation catheter of example 1 in a balloon radially-expanded state;
FIG. 3 is an enlarged view of FIG. 2 at A;
FIG. 4 is a schematic view showing a part of the balloon skeleton of the balloon dilation catheter of example 1 and a part of the catheter (the balloon skeleton is in a radially contracted state);
FIG. 5 is a schematic structural view of the balloon body of the balloon dilation catheter of example 1;
FIG. 6 is a schematic cross-sectional view of the balloon inflation conduit of the balloon dilation catheter of example 1;
FIG. 7 is a schematic cross-sectional view of the balloon dilation catheter of example 1 in a radially expanded state of the balloon (with the balloon skeleton removed);
FIG. 8 is a schematic view showing the structure of a balloon dilation catheter of example 2 in a balloon radially-expanded state;
FIG. 9 is a schematic view showing a partial structure of the balloon dilation catheter of example 2 in a balloon radially-expanded state (with the operating handle omitted);
Figure 10 is a schematic view showing the partial structure of the balloon dilation catheter of example 2 in a balloon radially expanded state (with the operating handle and balloon removed),
In the figures, 1, an operating handle, 11, a first inlet and outlet, 12, a second inlet and outlet, 2, a catheter, 21, a first cavity, 22, a second cavity, 3, a balloon skeleton, 31, a first ring, 32, a second ring, 4, a balloon body, 41, a balloon filling pipeline, 51, a first guide rail, 52, a second guide rail, 53, a basket, 6, a first adjusting piece, 61, a strip-shaped groove, 7, a second adjusting piece, 81, a first external thread, 82, a second external thread, 83, a deflector wheel, 84 and a transmission piece.
Detailed Description
Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
In the description of the present invention, it will be understood that distal refers to the end of the instrument or component that is distal from the operator, proximal refers to the end of the instrument or component that is proximal to the operator, axial refers to the direction parallel to the line connecting the distal end of the instrument or component to the center of the proximal end, and radial refers to the direction perpendicular to the axial, and inner and outer refer to positions defined by the distance from the center of the instrument or component, wherein inner is the position proximal to the center of the instrument or component and outer is the position distal from the center of the instrument or component. The above description of orientation words is merely for convenience in describing embodiments of the present invention and for simplicity of description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting embodiments of the present invention.
In the description of the present invention, unless explicitly stated and limited otherwise, the terms "coupled," "affixed," and the like are to be construed broadly, and may be, for example, fixedly coupled, detachably coupled, or integrally formed. The specific meaning of the above terms in the embodiments of the present invention will be understood by those of ordinary skill in the art according to specific circumstances.
In the description of the present invention, plural means two or more.
In the invention, the calculation method of the compliance is that the compliance is = { (diameter @ rated burst pressure-diameter @ nominal pressure)/(rated burst pressure-nominal pressure) } ×100%, the nominal pressure is the pressure born by the balloon in normal operation, and the rated burst pressure is the maximum pressure born by the balloon at the moment of rupture.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Example 1
The embodiment is an implementation manner of the balloon dilation catheter of the present invention, and specifically as shown in fig. 1 to 7, the balloon dilation catheter comprises an operation handle 1, a catheter 2, a balloon skeleton 3, a balloon body 4, a clamping assembly, a first adjusting piece 6, a second adjusting piece 7 and an adjusting locking mechanism.
In particular, the catheter 2 has a first lumen 21 for passage of a guidewire and a second lumen 22 for passage of a gas or liquid. The first lumen 21 extends from the proximal end to the distal end of the catheter 2 and is open at both ends. The second lumen 22 extends distally from the proximal end of the catheter 2 but does not reach the distal end, i.e. the distal end of the second lumen 22 is blocked. In this embodiment, the cross section of the first channel 21 is circular, and the cross section of the second channel 22 is crescent-shaped. In this embodiment, the first lumen 21 may be through a guidewire having a size of 0.035 inches or less.
Specifically, the operating handle 1 is sleeved on the proximal end of the catheter 2, a containing cavity is arranged in the operating handle 1, and a first inlet and outlet 11 communicated with the first cavity channel 21 and a second inlet and outlet 12 communicated with the second cavity channel 22 are arranged on the operating handle 1.
Specifically, the balloon skeleton 3 can radially expand or radially contract, the balloon skeleton 3 is axially sleeved on the outer periphery of the distal end of the catheter 2, and the proximal end of the balloon skeleton 3 and the distal end of the balloon skeleton 3 can respectively slide along the axial direction of the catheter 2. In this embodiment, the balloon skeleton 3 has a plurality of mesh structures sequentially connected along the axial direction and the circumferential direction, the distal end of the balloon skeleton 3 is provided with a radially invariable first ring 31, the proximal end of the balloon skeleton 3 is provided with a radially invariable second ring 32, and the balloon skeleton 3 is made of a PEEK material (TECAPEEK MT XRO GREEN) which is visible by X-rays and conforms to biocompatibility.
Specifically, the compliance of the balloon body 4 is less than or equal to 5%, the balloon body 4 is sleeved outside the balloon skeleton 3 in an axial clamping manner, the cross section of the balloon body 4 is C-shaped, and the balloon body 4 is provided with a balloon body filling pipeline 41 for communicating the inside of the balloon body 4 with the second cavity 22. In this embodiment, a filling port is formed on a side wall of the balloon body 4, which is close to the balloon skeleton 3, one end of the balloon body filling pipeline 41 is funnel-shaped with an opening, the opening is communicated with the filling port, the other end passes through the balloon skeleton 3 and the second cavity 22, and the balloon body filling pipeline 41 is provided with reserved folds through laser welding. The bag body 4 is made of PEBAX material, the bag body 4 and the bag body filling pipeline 41 are integrally formed under blow molding, the formed flat bag body is subjected to C-shaped bending deformation, shaping is carried out at high temperature, the outer side surface of the bag body 4 is coated with a hydrophilic coating, ultraviolet rays are used for curing, a PET (polyethylene terephthalate) braiding wire is used for covering the outer surface with a braiding layer (comprising the bag body filling pipeline), the appearance of the bag body 4 after the braiding layer is reinforced is more stable, the flexibility performance is good, and the compliance can be reduced to within 5%. The above processes are conventional in the art and are not described herein.
Specifically, the clamping assembly is arranged between the balloon framework 3 and the balloon body 4 and is used for connecting the balloon framework 3 and the balloon body 4. In this embodiment, the clamping assembly includes a rail, a slider, and a basket 53. The guide rail is fixedly arranged on one side wall of the balloon body 4, which is close to the balloon skeleton 3, along the axial direction, and comprises a first guide rail 51 and a second guide rail 52, wherein the first guide rail 51 extends from the distal end of the balloon body 4 to the middle part of the balloon body 4, the second guide rail 52 extends from the proximal end of the balloon body 4 to the middle part of the balloon body 4, and a distance exists between the proximal end of the first guide rail 51 and the distal end of the second guide rail 52. The first guide rail 51 and the second guide rail 52 are made of 304 stainless steel, and are adhered to two opposite sides of the filling opening of the bag body 4 through glue. The first guide rail 51 and the second guide rail 52 are both provided with a groove-shaped slideway extending from the proximal end to the distal end, and the groove-shaped slideway is made of silicon rubber added with contrast agent. The sliding blocks comprise a plurality of sliding blocks which are distributed at intervals along the axial direction, a plurality of sliding blocks are connected in the groove-shaped sliding way of the first guide rail 51 and the groove-shaped sliding way of the second guide rail 52 in a sliding manner, the sliding blocks in the embodiment are outwards-protruding balls fixedly arranged at the top points of meshes, and a good sliding effect is achieved when the sliding blocks are embedded into the groove channels. The basket 53 is a hollow structure with two open ends, two open sides of one end of the basket are respectively and fixedly connected with the proximal end of the first guide rail 51 and the distal end of the second guide rail 52, the other end of the basket is fixedly connected with the catheter 2, and the capsule filling pipeline 41 is arranged in the basket 53 in a penetrating way. The basket 53 is welded to the catheter 2, the first rail and the second rail, respectively, so that they can be formed as a single body, and the single body is hardly displaced in the axial direction when the balloon frame 3 is deformed. The basket 53 is shaped like an open funnel, one side of which is connected to the proximal end of the first rail 51, and the other side is connected to the distal end of the second rail 52, and the basket 53 is made of a flexible material and can be pulled and deformed.
Specifically, the first adjusting member 6 is fixedly connected with the distal end of the balloon skeleton 3, and is slidably connected with the proximal end of the balloon skeleton 3. The second adjusting piece 7 is fixedly connected with the proximal end of the balloon skeleton 3. The adjusting and locking mechanism can adjust and lock the relative position between the proximal end of the balloon frame 3 and the distal end of the balloon frame 3, and comprises a first matching part arranged on the first adjusting piece 6, a second matching part arranged on the second adjusting piece 7, and a third matching part arranged on the operating handle 1 and respectively matched with the first matching part and the second matching part, when the first adjusting piece 6 moves proximally and the second adjusting piece 7 moves distally, the distance between the proximal end and the distal end of the balloon frame 3 is reduced, the radial direction of the balloon frame 3 is expanded, the C-shaped opening of the balloon body 4 is further expanded, the radial direction of the balloon body 4 is further expanded, the distance between the proximal end and the distal end of the balloon frame 3 is further increased when the first adjusting piece 6 moves distally and the second adjusting piece 7 moves proximally, the radial direction of the balloon frame 3 is further contracted, and the C-shaped opening of the balloon body 4 is further contracted.
In this embodiment, the first adjusting member 6 is a hollow tubular structure, and is axially slidably sleeved on the catheter 2, the balloon skeleton 3 is axially sleeved outside the first adjusting member 6, the distal end of the balloon skeleton 3 is fixedly connected with the distal end of the first adjusting member 6, a strip-shaped groove 61 extending along the axial direction is formed in the portion, located in the balloon skeleton 3, of the first adjusting member 6, the balloon filling pipe 41 passes through the balloon skeleton 3 and the strip-shaped groove 61 to be communicated with the second cavity 22, the basket 53 passes through the balloon skeleton 3 and the strip-shaped groove 61 to be connected with the strip-shaped groove 61 and the outer wall of the catheter 2, the second adjusting member 7 is a hollow tubular structure, and is axially slidably sleeved on the first adjusting member 6, and the distal end of the second adjusting member 7 is fixedly connected with the proximal end of the balloon skeleton 3.
In this embodiment, the first adjusting member 6 and the second adjusting member 7 extend into the accommodating cavity respectively, the first matching portion is a first external thread 81 formed on the outer side wall of the proximal end of the first adjusting member 6, the second matching portion is a second external thread 82 formed on the outer side wall of the proximal end of the second adjusting member 7, the spiral directions of the first external thread 81 and the second external thread 82 are opposite, the pitch of the first external thread 81 is the same as or different from the pitch of the second external thread 82, the third matching portion comprises a dial wheel 83 and a transmission member 84, the dial wheel 83 is rotatably arranged on the operating handle 1 around the self axis direction and is partially positioned in the accommodating cavity, the transmission member 84 is engaged with the dial wheel 83, the transmission member 84 is rotatably arranged in the accommodating cavity around the self axis direction, the transmission member 84 is axially sleeved on the second adjusting member 7, a first internal thread is formed on the inner side wall of the proximal end of the transmission member 84, a second internal thread is formed on the inner side wall of the distal end of the transmission member 84, the proximal end of the transmission member 84 and the second external thread 84 are rotatably connected with the second external thread 84 around the second axis direction by the second external thread of the second adjusting member 6, when the proximal end of the transmission member 84 and the second external thread 84 are rotatably connected with the second external thread 84 around the second external thread of the second adjusting member 6 in the self-rotation direction, the second external thread is driven by the second external thread 84 around the second external thread of the second external thread 84, and the transmission member 84 is rotated around the second external thread 84 around the second external thread of the proximal end of the second external thread 84 and the proximal end of the second adjusting member 84, thereby driving the first regulating member 6 to move distally and the second regulating member 7 to move proximally, one of the first direction and the second direction being clockwise, the other being counterclockwise, one of the third direction and the fourth direction being clockwise, the other being counterclockwise.
More specifically, in the present embodiment, the first regulating member 6 and the second regulating member 7 are respectively formed of 204 stainless steel high-toughness hollow thin pipes. In this embodiment, the pitch of the first external thread 81 is the same as the pitch of the second external thread 82. The adjusting method of the balloon dilation catheter of the embodiment comprises the following steps:
When the thumb pushes the thumb wheel 83 forward to rotate, the distal end of the balloon frame 3 moves proximally and the proximal end of the balloon frame 3 moves distally, and as the distance between the distal end of the balloon frame 3 and the proximal end of the balloon frame 3 decreases, the C-shaped opening of the balloon 4 expands, and the radial direction of the balloon 4 expands.
When the thumb dial wheel 83 is rotated, the distal end of the balloon frame 3 moves distally and the proximal end of the balloon frame 3 moves proximally, and as the distance between the distal end of the balloon frame 3 and the proximal end of the balloon frame 3 increases, the C-shaped opening of the balloon 4 decreases, and the radial direction of the balloon 4 decreases.
In this embodiment, the inner diameter of the balloon 4 remains constant from the distal end of the balloon 4 to its proximal end.
Example 2
This example is another embodiment of the balloon dilation catheter of the present invention which is substantially identical to example 1 except that the pitch of the first external threads 81 is less than the pitch of the second external threads 82. In the balloon dilation catheter adjusting method of this embodiment, as shown in fig. 8-10, when the thumb pushes the thumb wheel 83 forward to rotate, the distal end of the balloon skeleton 3 moves proximally and the proximal end of the balloon skeleton 3 moves distally, the C-shaped opening of the balloon body 4 expands with the reduction of the distance between the distal end of the balloon skeleton 3 and the proximal end of the balloon skeleton 3, the radial direction of the balloon body 4 expands with the expansion of the C-shaped opening of the balloon body 4, but the degree of diameter variation of the distal end of the balloon skeleton 3 is smaller than the degree of diameter variation of the proximal end, so that the degree of expansion of the C-shaped opening of the distal end of the balloon body 4 is smaller than the degree of expansion of the C-shaped opening of the proximal end of the balloon body 4, and the inner diameter of the balloon body 4 gradually decreases from the proximal end of the balloon body 4 to the distal end thereof, as the axial direction of the balloon body 4 is adjusted.
The balloon dilation catheter of the above embodiment is adjusted after the balloon 4 is filled, and the balloon is decompressed by the balloon 4 and the balloon skeleton 3 is contracted radially to enter and exit the human body.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.