Disclosure of Invention
In view of the above, it is desirable to provide a stent, implant, delivery device and delivery system that address at least one of the technical problems mentioned above.
The present application provides a stent, the stent comprising:
A cell ring having a deformability, the cell ring being presentable in either an expanded state or a contracted state based on the deformability; the number of the unit rings is set to be a plurality, the unit rings are sequentially connected along the axial direction to form the bracket, at least part of the unit rings are collar-changing bodies, and different annular side positions of the annular circumference of the collar-changing bodies have different axial widths, so that different adjacent positions of the annular circumference between adjacent collar-changing bodies have different axial gap widths.
In one embodiment, the annular circumference of the variable shaft ring body has a first annular side reference position and a second annular side reference position, the axial width of the first annular side reference position of the variable shaft ring body is minimum, and the axial width of the second annular side reference position of the variable shaft ring body is maximum.
In one embodiment, the axial width of the annular side of the annular circumference of the collar body is gradually increased along the direction from the first annular side reference to the second annular side reference, and/or,
The first ring side reference level and the second ring side reference level are arranged on two radial symmetrical sides of the variable shaft ring body.
In one embodiment, a third ring side reference position is provided at a central position between the first ring side reference position and the second ring side reference position, the ring circumference of the variable shaft ring body has two radially symmetrical third ring side reference positions, the axial width of the first ring side reference position is a first axial width, the axial width of the second ring side reference position is a second axial width, and the axial width of the third ring side reference position is a third axial width;
Wherein the first axial width is the second axial width and the third axial width=0.4-0.7:1.4-1.6:0.8-1.2.
In one embodiment, the collar body comprises a plurality of unit rods along the annular circumference of the collar body, at least part of the unit rods are obliquely arranged relative to the axial direction of the collar body, so that the plurality of unit rods are sequentially connected end to end along the annular circumference of the collar body to form the collar body, at least part of the unit rods contained in the collar body have different rod body lengths, the axial widths of different ring side positions of the collar body are the axial projection sizes of the unit rods at which the different ring side positions of the collar body are located, and/or,
And part of the unit ring positioned in the distal direction of the bracket is the variable shaft ring body.
The present application provides an implant comprising:
the support;
and the coating is assembled on the surface of the bracket body of the bracket.
In one embodiment, the implant includes an adjustment wire connected to at least one of the variable collar bodies of the stent and connected to a lateral annular location of minimum axial width of the variable collar body, and/or,
The implant comprises a protective film, the flexibility of the protective film is larger than that of the covering film, the protective film is assembled outside the bracket and the covering film, and/or,
The implant includes a developing element disposed on the support, and/or,
The material of the coating is terylene and/or,
The thickness of the coating is between 0.05mm and 2mm, and/or the coating comprises a main body area and a proximal coverage area, wherein the proximal coverage area is used for covering the distal end of the bracket, the thickness of the main body area of the coating is between 0.05mm and 0.15mm, and the thickness of the proximal coverage area of the coating is between 1mm and 2 mm.
In one embodiment, the stent comprises a distal stent section, a middle stent section and a proximal stent section along the axial direction thereof, the covering film comprises a first film section and a second film section, the first film section is assembled on the distal stent section, the second film section is assembled on the proximal stent section, or
The support contains distal end frame section, middle part frame section and proximal end frame section along its axial, the tectorial membrane includes first membrane section, second membrane section and connection membrane section, first membrane section assemble in distal end frame section, the second membrane section assemble in proximal end frame section, connection membrane section cover part middle part frame section.
The present application provides a conveying device, comprising:
an outer sheath tube, wherein the inner part of the outer sheath tube is provided with a sheath tube inner cavity which is axially penetrated;
the inner core tube is provided with an axially-through core tube inner cavity, the inner core tube is movably arranged in the sheath tube inner cavity of the outer sheath tube in a penetrating mode, and a tube layer gap between the outer sheath tube and the inner core tube is used for accommodating the implant.
The present application provides a conveying system, comprising:
The implant, and the delivery device.
In the above-mentioned support, implant, conveyor and conveying system, based on the structural design of support itself, just the curved structure of self-adaptation ascending aorta after the support is planted, receive the extrusion force that ascending aorta applyed to the support after for the axial shrinkage of different degree takes place for the big curved side of support self and little curved side, and the shrinkage degree of big curved side and little curved side of support is different, produces the difference, and this difference is adapted to the length of big curved side and little curved side of ascending aorta, from this the beak phenomenon emergence of self-adaptation solution.
Detailed Description
In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.
In the description of the present application, it should be understood that, if any, these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., are used herein with respect to the orientation or positional relationship shown in the drawings, these terms refer to the orientation or positional relationship for convenience of description and simplicity of description only, and do not indicate or imply that the apparatus or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the application.
Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.
In the present application, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, they may be fixedly connected, detachably connected or integrally formed, mechanically connected, electrically connected, directly connected or indirectly connected through an intermediate medium, and communicated between two elements or the interaction relationship between two elements unless clearly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present application, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.
For purposes of more clarity in describing stents, implants, delivery devices, and delivery systems, the term "distal" is defined herein to mean the end that is distal from the operator during a surgical procedure, and "proximal" means the end that is proximal to the operator during a surgical procedure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
Referring to fig. 1 to 4, the present application provides an implant 100, wherein the implant 100 comprises a stent 1000 and a cover 2000, and the cover 2000 is assembled on the surface of the stent 1000, thereby forming a covered stent, that is, the implant 100, together with the stent 1000 and the cover 2000, as shown in fig. 1. With continued reference to fig. 1 to 4, the stent 1000 includes a unit ring 1100, where the unit ring 1100 has a deformation capability, for example, the unit ring 1100 may be made of a suitable memory metal, etc., so that the unit ring 1100 may have the deformation capability mentioned above, so that the unit ring 1100 may be in an expanded state or a contracted state based on the deformation capability, and a person skilled in the art may select a material, a shape, a size, etc. of the unit ring 1100 according to actual needs, so as to construct a suitable stent 1000 for use in the medical field, which is not limited herein.
With continued reference to fig. 1 and 2, the number of cell rings 1100 is set to a plurality, and the plurality of cell rings 1100 are sequentially connected in the axial direction thereof to form the stent 1000, so that the stent 1000 composed of the plurality of cell rings 1100 can also assume an expanded state or a contracted state based on deformability. Among them, the plurality of unit rings 1100 constituting the above-described stent 1000 may be the same-sized, same-shaped unit rings 1100, thereby constituting a cylindrical stent 1000 having uniform (same diameter) axial different positions. Alternatively, as shown in fig. 1 and 2, in one embodiment, different cell rings 1100 that make up axially different frame segments of the stent 1000 may also take on different sizes, different shapes, etc., thereby making up a cylindrical stent 1000 that exhibits different configurations in axially different positions or frame segments. The structure, shape, size, etc. of the bracket 1000 can be set by those skilled in the art according to actual needs, and are not limited herein.
For example, in one embodiment, at least a part of the unit rings 1100 or all of the unit rings 1100 of the plurality of unit rings 1100 are provided as the collar body 1200, for example, as shown in fig. 1 and 2, the frame body section of the part of the unit rings 1100 located in the distal direction of the stent 1000 is provided as the collar body 1200. The variegated ring body 1200 may be defined as a structure as shown in fig. 3 and 4, that is, different ring side positions in the circumferential direction of the ring of the variegated ring body 1200 have different axial widths 1211, the ring side referring to the ring body side of the unit ring 1100. When a plurality of such collar bodies 1200 are connected in sequence along the axial direction, constituting a partial frame body section of the stent 1000, in the partial frame body section of the stent 1000 constituted by the collar bodies 1200, different axial gap widths 1212 can be made between different adjacent positions in the circumferential direction of the rings between adjacent collar bodies 1200.
For example, in one embodiment, as shown in fig. 3 and 4, the collar body 1200 includes a plurality of unit rods 1210 along the circumferential direction thereof, at least a portion of the unit rods 1210 are disposed obliquely with respect to the axial direction of the collar body 1200, such that the plurality of unit rods 1210 are sequentially connected end to end along the circumferential direction of the collar body 1200 to form the collar body 1200, at least a portion of the unit rods 1210 included in the collar body 1200 have different rod body lengths, and the axial widths 1211 of the different ring side positions of the collar body 1200 are the axial projection dimensions of the unit rods 1210 of the different ring side positions of the collar body 1200, i.e., the projection dimensions to the plane of the axis of the bracket 1000.
It follows that in the structural design of the stent 1000 described above, at least part of the stent 1000 segments may be connected in series in the axial direction of the stent 1000 by the above-mentioned collar body 1200 as a unit ring 1100. When a plurality of the collar bodies 1200 are arranged along the axial direction of the stent 1000, different axial gap widths 1212 are formed between different adjacent positions in the circumferential direction of the rings between adjacent collar bodies 1200 in the partial stent segments of the stent 1000 formed by the collar bodies 1200.
The structural design of the bracket 1000 can be used for solving the beak phenomenon generated after the bracket 1000 is implanted into a body. Referring to fig. 5, regarding the ascending aorta, the ascending aorta major curved side length, the ascending aorta centerline length, and the ascending aorta minor curved side length are different, the ascending aorta major curved side length is greater than the ascending aorta minor curved side length, and the ascending aorta centerline length is located between the ascending aorta major curved side length and the ascending aorta minor curved side length. Therefore, the stent 1000 is difficult to attach to the inner wall of the artery well due to the natural curvature of the aortic arch and the uncertain positional relationship of the openings, especially for patients with sharp curvature of the aortic arch.
As shown in fig. 5, in the axial frame segments of the stent 1000 of a1 to a2 of the stent 1000, that is, the portion of the stent 1000 corresponding to the small-curvature side of the ascending aorta, the axial frame segments of the stent 1000 of b1 to b2, that is, the portion of the stent 1000 corresponding to the large-curvature side of the ascending aorta, and the axial frame segments of the stent 1000 of c1 to c2, that is, the portion of the stent 1000 corresponding to the centerline of the ascending aorta. When the stent 1000 is implanted, it is bent toward the small curvature side of the ascending aorta, and based on its deformation recovery capability, the axial frame segments b1 to b2 of the stent 1000 may be attached to the large curvature side of the ascending aorta, and the lengths of the axial frame segments b1 to b2 of the stent 1000 are substantially the length of the large curvature side of the ascending aorta, but as shown in fig. 5, the axial frame segments of the stent 1000 a1 to a2 may have a tendency to be away from the small curvature side of the ascending aorta, so that a gap is generated between the axial frame segments of the stent 1000 a1 to a2 and the small curvature side of the ascending aorta, i.e. the beak as shown in fig. 5. The phenomenon of a wedge-shaped gap between the stent 1000 and the wall of the ascending aortic blood vessel due to incomplete attachment of the distal end of the stent 1000 as shown in fig. 5 is called "bird's beak" effect.
In order to adapt to the natural curvature of the aortic arch, the above-mentioned bird's beak phenomenon can be solved by adapting the position of the annular side (side) of the stent 1000 with the smaller axial gap width 1212 to the position of the aortic macrocurvature based on the structural design of the stent 1000, and the position of the annular side (side) of the stent 1000 with the smaller axial gap width 1212 can be referred to as the macrocurvature of the stent 1000. The location of the loop side (side) of the stent 1000 where the axial gap width 1212 is greater corresponds to the location of the lesser curvature of the ascending aorta, at which time the location of the loop side (side) of the stent 1000 where the axial gap width 1212 is greater may also be referred to as the greater curvature of the stent 1000.
When the stent 1000 is implanted in the ascending aorta and bends itself in response to the bending structure of the ascending aorta, the stent 1000 has a large axial gap width 1212 after receiving the extrusion force of the ascending aorta on the small-curvature side of the ascending aorta, so that the stent 1000 can shrink in the axial direction to a large extent, and the axial length of the portion of the stent 1000 corresponding to the small-curvature side of the ascending aorta can be reduced to a large extent.
For example, referring to fig. 6, the axial frame segments a 1-a 2 of the stent 1000 may shrink in axial length after being stressed, and the axial length of a 1-a 2 of the stent 1000 may be reduced to a greater extent in fig. 6 than the axial length of a 1-a 2 of the stent 1000 in fig. 5, so that the tendency of the distal end of the stent 1000 to recover toward the greater curvature of the ascending aorta may be reduced to a greater extent, and may then be more closely attached to the lesser curvature of the ascending aorta as shown in fig. 6. Therefore, the stent 1000 can be made to adapt to the difference in size between the large curved side and the small curved side of the ascending aorta, and the occurrence of the bird's beak phenomenon can be reduced or avoided.
The above-mentioned manner of solving the beak phenomenon is realized based on the structural design of the stent 1000 itself, that is, the stent 1000 is self-adapted to the bending structure of the ascending aorta after being implanted, after receiving the extrusion force applied by the ascending aorta to the stent 1000, the large curved side and the small curved side of the stent 1000 themselves are axially contracted to different extents, and the contraction extents of the large curved side and the small curved side of the stent 1000 are different, so as to generate a difference, and the difference is adapted to the lengths of the large curved side and the small curved side of the ascending aorta, thereby self-adaptively solving the beak phenomenon.
With respect to the structural design of the collar body 1200, with continued reference to fig. 3 and 4, in one embodiment, the annular circumference of the collar body 1200 may be defined to have a first annular side reference 1110 and a second annular side reference 1120, with the axial width 1211 of the first annular side reference 1110 of the collar body 1200 being set to be the smallest and the axial width 1211 of the second annular side reference 1120 of the collar body 1200 being the largest. At this time, the first annular reference position 1110 of the collar body 1200 corresponds to the small-curvature side of the ascending aorta, and the second annular reference position 1120 of the collar body 1200 corresponds to the large-curvature side of the ascending aorta. In one embodiment, along the direction from the first ring side reference position 1110 to the second ring side reference position 1120, the axial width 1211 of the ring side defining the annular circumference of the collar body 1200 may be gradually increased, or the axial width 1211 of the ring side defining the annular circumference of the collar body 1200 may be increased in a stepwise or other special design manner, for example, without limitation.
The first and second ring-side reference levels 1110 and 1120 may be disposed on radially symmetrical sides of the collar body 1200, thereby enabling better correspondence to the greater and lesser curvature sides of the ascending aorta. In addition, the first annular side reference 1110 and the second annular side reference 1120 may be set at radial positions of the collar body 1200 according to the specific curvature of the ascending aorta by those skilled in the art, so as to better correspond to the greater curvature side and the lesser curvature side of the ascending aorta, which is not limited herein.
Further, as shown in fig. 3, in one embodiment, a third ring side reference position 1130 is provided at a central position between the first ring side reference position 1110 and the second ring side reference position 1120, the ring-shaped circumference of the ring-shaped body 1200 has two radially symmetrical third ring side reference positions 1130, the axial width 1211 of the first ring side reference position 1110 is a first axial width 1111, the axial width 1211 of the second ring side reference position 1120 is a second axial width 1121, and the axial width 1211 of the third ring side reference position 1130 is a third axial width 1131.
First axial width 1111: second axial width 1121: third axial width 1131=0.4-0.7:1.4-1.6:0.8-1.2. For example, the first axial width 1111:second axial width 1121:third axial width 1131=0.4:1.4:0.8, or the first axial width 1111:second axial width 1121:third axial width 1131=0.5:1.5:0.9, or the first axial width 1111:second axial width 1121:third axial width 1131=0.5:1.5:1, etc., are not limited herein.
In addition, in one embodiment, the implant 100 may further include an adjustment wire 3000, the adjustment wire 3000 being coupled to at least one of the collar bodies 1200 of the stent 1000, and the adjustment wire 3000 being coupled to the collar body 1200 at a location on the annulus that is the smallest of the axial widths 1211. Therefore, after the stent 1000 is implanted into the ascending aorta, if the beak phenomenon is not completely eliminated based on the structural design of the stent 1000, the adjusting wire 3000 can be pulled in vitro, so that the adjusting wire 3000 applies pulling force for pulling back to the distal end of the stent 1000, the distal end of the stent 1000 is tightly attached to the small curve side of the ascending aorta by using external force intervention, the shape of the stent 1000 is changed, the poor adhesion condition of the stent 1000 is improved, and the beak phenomenon is manually solved. The manual adjustment mode can be performed after the beak phenomenon is solved by the structural design of the bracket 1000, and belongs to secondary auxiliary adjustment, namely, the beak phenomenon is solved in a manual mode, so that the beak phenomenon can be further eliminated, and a self-adaptive adjustment and manual adjustment dual adjustment mode is formed.
Because the outer surface of the existing implant 100 (stent graft) is sharp, the longer life cycle content is vulnerable to damage to the intima of the interlayer. The implant 100 can be further provided with a protective film, the flexibility of the protective film is greater than that of the covering film 2000, the protective film is assembled outside the support 1000 and the covering film 2000, the protective film can be made of flexible high polymer materials, the flexible high polymer materials are added on the outer surface of the implant 100 (the covering film support), so that the flexible high polymer materials are attached to the interlayer inner film, the damage to the interlayer inner film at the positions of metal, suture knot points and the like of the implant 100 (the covering film support) is reduced, and the risk of rupture of a new interlayer or an interlayer is reduced. The distal end of the implant 100 (stent graft) is added with a flexible polymer material, which has the characteristics of small pores, no blood seepage and the like, and is beneficial to anastomosis of the long-term stent graft and the blood vessel.
The implant may further include a developing element disposed on the support, for example, the developing element may be disposed in one or more of the developing elements, and the developing element may be disposed at a suitable position such as an arch portion of the support according to a requirement, so that the support is beneficial to positioning of the support during the implantation process by using a developing function of the developing element, and a person skilled in the art may dispose the developing element at any suitable position on the support according to a practical requirement, which is not limited herein.
The material of at least a portion of the film 2000 may be dacron, and the thickness of the film may be between 0.05mm and 2mm, for example, the thickness of the film is 0.1mm, 0.2mm, 0.3mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm. Wherein the cover film 2000 may be defined to include a body region and a proximal cover region that are joined together to form the entirety of the cover film 2000.
The proximal coverage area is used to cover the proximal end of the stent 1000, so the area ratio of the proximal coverage area in the covering film 2000 can be designed according to the actual requirement of covering the proximal end of the stent 1000, and is not limited herein. At this time, the thickness of the proximal coverage area of the covering film 2000 may be limited to 1mm to 2mm, and the thickness of 1mm to 2mm may make the covering film 2000 easier to stitch, and the thickness range of the proximal coverage area may not cause blood leakage in the needle hole when the covering film 2000 is needled. In contrast, the thickness of the main body region of the coating film 2000 may be defined as 0.05mm to 0.15mm.
Referring to fig. 6, in one embodiment, the stent 1000 comprises a distal stent section, a middle stent section, and a proximal stent section along its axial direction, the middle stent section being intermediate the distal and proximal stent sections. At this time, the covering film 2000 includes a first film segment 2100 and a second film segment 2200, the first film segment 2100 is assembled on the distal end frame segment, the second film segment 2200 is assembled on the proximal end frame segment, and the middle frame segment in the middle is not covered by the covering film 2000, so that the implant 100 forms a semi-covered semi-bare segment structure, the semi-covered film formed by the first film segment 2100 and the second film segment 2200 can be used for blocking the arch interlayer, and the semi-bare segment between the first film segment 2100 and the second film segment 2200 (i.e. the exposed middle frame segment not covered by the covering film 2000) can ensure the smooth blood flow of the arch.
The cover film 2000 may also include a connecting film segment connecting the first film segment 2100 and the second film segment 2200, the connecting film segment covering a portion of the middle frame segment. That is, the middle section of the stent 1000 may also be covered by the connecting section of the covering film 2000 on the part of the surface, on the basis that the first section 2100 is assembled to the distal section and the second section 2200 is assembled to the proximal section.
For example, the small curved side of the middle frame section is covered by the covering film 2000, while the large curved side of the middle frame section still keeps the exposed state uncovered by the covering film 2000, which is designed as a partial circumferential covering film of the middle frame section of the stent 1000, and at this time, the small curved side of the middle frame section of the stent 1000 is covered by the covering film 2000, so that the small curved side of the arch section is effectively blocked from being broken or ulcerated, the false cavity is prevented from being broken, and the large curved side of the middle frame section of the stent 1000 still keeps the exposed state uncovered by the covering film 2000, so that the blood supply of the three branches of the arch section is not affected.
Those skilled in the art can design the surface area covered by the covering film 2000 and the surface area not covered by the covering film 2000 for the middle frame section of the stent 1000 according to actual requirements, thereby meeting the technical problems of three-branch blood supply, small-curve side breach or ulcer blocking and the like, and the technical problems are not limited herein.
Referring to fig. 7 to 9, the present application provides a delivery device 200, wherein the delivery device 200 comprises an outer sheath 210, an inner core tube 220, a guide wire and a traction wire 230, wherein the outer sheath 210 has an inner sheath cavity passing through axially, the inner core tube 220 has an inner core cavity passing through axially, the inner core tube 220 is movably disposed in the inner sheath cavity of the outer sheath 210, and a tube gap between the outer sheath 210 and the inner core tube 220 is used for accommodating an implant 100. The guide wire is movably inserted into the core tube cavity of the inner core tube 220, and the guide wire can form a guide track for implanting the inner core tube 220 to a target position in the body, so that the inner core tube 220 and the whole conveying device 200 can be accurately implanted to the target position in the body along the guide wire.
The traction wire 230 can apply a withdrawal force to the implant 100 by withdrawing, and is used for pulling the distal end of the implant 100 in the proximal direction, and the distal end of the stent 1000 is tightly attached to the small curve side of the ascending aorta by using external force intervention, so that the shape of the stent 1000 is changed, the poor adhesion condition of the stent 1000 is improved, and the beak phenomenon is manually solved.
The present application provides a delivery system comprising an implant 100 as described above and a delivery device 200. Since the specific structure, functional principle and technical effects of the implant 100 and the delivery device 200 are described in detail above, the description is omitted herein for brevity, and any technical contents related to the implant 100 and the delivery device 200 are referred to in the foregoing description.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.