Abstract:
The present invention preferably includes a balloon catheter for use with a guidewire. The catheter has a body with a balloon located thereon, preferably at the distal end. A lumen within the catheter body communicates with the interior of the balloon which can be inflated by known methods with saline solution. A series of sleeve members of predetermined lengths and sizes are coupled to and positioned along the length of the catheter body. One or more of the sleeve members can span the length of the balloon. Each sleeve member has a passageway and both an exit and entry port so that the guidewire can pass therethrough. Instead of a balloon, the catheter can include a device member that forms a chamber which can store medicine until discharged at the desired site within the blood vessel. Apertures or pores on the catheter body allow for the perfusion of blood or the delivery of medicine to the site of the blood vessel. A method of operation is also disclosed.

Description:
This application is a continuation of application Ser. No. 08/932,726, filed Sep. 18, 1997, now U.S. Pat. No. 6,056,722. 
    
    
     FIELD OF THE INVENTION 
     The present invention is directed to catheters for delivering balloons, drugs, stents, and other devices or agents into the arterial or venal systems of the human body. In particular, this invention relates to catheters that provide a quick, efficient and rapid exchange capability for the delivery of an angioplasty balloon into the arterial vessels of the human heart. 
     BACKGROUND ART 
     The human body includes arterial and venous conduits which run throughout various sections of the human body. These conduits conduct blood into and from the heart which maintain the circulation that helps to sustain the metabolic events in the body. The vessels undergo biological, physiological and mechanical changes depending on the body metabolism which determine the functionality of the wall of the artery. 
     Sometimes the wall of an artery becomes occluded due to deposits of fatty tissues which in turn form plaque on the walls of the artery. These plaques then have to removed to restore the normal function of the artery. One known mechanism of removing the plaque is to compress the plaque against the wall of the artery using a balloon catheter. This procedure is called Percutaneous (under the skin) Transluminal (under x-ray guidance) Coronary (region of intervention) Angioplasty (plaque compression) or PTCA. 
     For a PTCA procedure to be accomplished, a balloon catheter and a guidewire along with a guiding catheter are typically required. The guiding catheter is normally introduced in a groin artery and pushed upwards towards the aorta until it reaches the mouth of the coronary artery. Once the guiding catheter is placed at the opening of the coronary artery, a highly floppy wire is introduced into the guiding catheter such that the wire crosses the mouth of the guiding catheter and goes into the coronary artery. It then has to reach the site of the lesion (plaque) which is usually a very tortuous route and the operator (the cardiologist) has to struggle to reach the guidewire in place. Once a guidewire has crossed the lesion, it is then pushed distally to the lesion so that it remains at a safe place. This is to ensure that the wire does not slip out of the lesion. 
     A catheter which has a balloon at one end and a shaft at the other end is usually introduced into the lesion on top of the guidewire. Although the mechanism of introduction and the design of the catheter that facilitate the mechanism have been improved by known catheters, they still leave room for improvement. 
     Several designs of balloon catheters are disclosed in various U.S. patents that facilitate insertion into the artery using a guidewire as an intermediate tool. The way in which the balloon travels on top of the guidewire and the length of the catheter that travels on top of the guidewire is the subject of known devices such as those shown and described in U.S. Pat. Nos. 5,620,417; 5,607,406; 5,607,394; 5,598,844; 5,549,556; 5,545,134; 5,531,690; 5,514,092; 5,077,311; 5,501,227; 5,489,271; 5,472,425; 5,468,225; 5,460,185; 5,458,613; 5,443,457; 5,413,560; 5,413,559; 5,409,097; 5,387,226; 5,383,853; 5,380,283; 5,357,978; 5,336,184; 5,334,147; 5,195,978; 5,170,286; 4,748,982; 4,762,129; and 5,626,600, all of which are incorporated herein in their entirety. 
     While each one of these above-listed patents describe and illustrate several ways of approaching the traverse mechanism, all of them essentially assume the following; (1) the catheter has proximal and distal ends; (2) there is a balloon mounted on the distal end; (3) the proximal end has a shaft; (4) the interior of the balloon is in communication with a lumen; (5) there is another sleeve that either extends towards the entire length of the catheter or runs at a fixed distance from the distal end of the catheter; (6) the sleeve if it does not run the entire length of the catheter extends up to a predetermined distance from the balloon up to the midsection of ⅓ of the entire catheter length or sometimes shorter; (7) the portion of the sleeve is called the flexible portion, while the proximal portion is either a hallow tube or an elliptical structure which provides for pushability of the catheter; (8) the sleeve has one opening at the proximal side of the balloon through which a guidewire can be inserted and it comes out through the center of the balloon—this is commercially known as the rapid exchange or the monorail concept; (9) in instances where the sleeve extends along the entire length of the balloon the wire extends inside the sleeve from the distal to the proximal end of the catheter through the balloon—this is called the over the wire concept. 
     In the devices of the above patents regardless of whether the catheter is over the wire or monorail, the guidewire has one entry point and one exit point and the regions between the entry and exit are imbedded in the catheter sleeve or the catheter shaft. 
     However, the catheters of the above patents have some serious disadvantages in lesions that are completely occluded or in lesions that have severe tortuosity. In lesions that have complex distal diseases the catheter has to traverse multiple bifurcations in order to reach the site of lesion. In case of the above described known catheters, the operator or the cardiologist forces the body of the catheter on top of the wire using an external force. This force then transmits from the catheter body to the surface of the wire. When the wire is held with a counteractive force, the force against the catheter becomes greater and a law of physics comes into play, the object with the greatest force moves forward. 
     In balloon angioplasty, it is desired to design a catheter which pushes on top of a wire with a minimum force. In order to achieve this, catheters with very low profiles are sought. These low profiles enable easy slippage on top of the wire. Sometimes the wires are also coated with a lubricous coating to enable ease of passage of the catheter. 
     In numerous instances, the operator is unable to cross a lesion with a rapid exchange catheter. He then switches over to an over the wire design or vice versa when the operator cannot transmit the necessary force for the balloon catheter to traverse the lesion. 
     In general rapid exchange catheter designs are preferred because there is only about ⅓ of the catheter body that is imbedded in the guidewire and hence the force required for the catheter to travel is less. In the case of total occlusions, over the wire designs are preferred as the catheter. If the catheter is being pushed through a very hard plaque or a totally occluded artery, the maximum force from the proximal end of the catheter has been delivered to the distal end. 
     The force delivered at the proximal end by the operator relates to the force of balloon moving forward toward the lesion. There are forces lost between the proximal end to the distal end of the catheter and this happens due to the tortuosity of the lesions, length of the shaft of the catheter and also lesion morphology. 
     Prior art inventions are easily understood if we draw a very simple analogy between the catheter and the guidewire. Assume the guidewire is the track of the train, and the catheter is the train. In the rapid exchange design, the train has one pair of small wheels that are the distal ⅓ of the catheter of the length of the sleeve. In the case of an over the wire design, the train has one pair of long wheels from the distal end of the catheter to the proximal end. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a catheter comprising body member having a lumen; balloon member disposed on the body member and communicating with the lumen; and plurality of sleeve members disposed on the body member, each sleeve member having a passageway therethrough. 
     In one preferred embodiment, at least one of the sleeve members is disposed in a distal region of the elongated member. The at least one of the sleeve members can be disposed adjacent the balloon member and can have a length less than that of the balloon member. The at least one of the sleeve members can be disposed within the balloon member. 
     According to a catheter of the present invention, at least one of the sleeve members can be disposed adjacent the balloon member and have a length greater than that of the balloon member. The at least one of the sleeve members extends through the balloon member. 
     In another preferred embodiment, the at least one of the sleeve members can be disposed generally centrally of the balloon member. 
     In alternative embodiments, the at least one of the members can be disposed generally eccentrically of the balloon member, or generally outside of the balloon member, or proximally of the balloon member. The remaining sleeve members can be equally sized and equally spaced along the catheter body. Alternatively, the remaining sleeve members can be differently sized and differently spaced along the catheter body. Preferably there are two or three remaining sleeve members. 
     The present invention is also directed to an angioplasty catheter comprising elongated body member having a lumen which includes an opening adjacent its distal end and at least one opening adjacent its proximal end; balloon member sealingly disposed on the elongated member adjacent its distal end, the elongated member having at least one opening communicating with the interior of the balloon and the lumen within the elongated body member; and plurality of sleeve members disposed on the elongated member, each sleeve member having a passageway therethrough. 
     An angioplasty catheter, according to the present invention, can also comprise guidewire dimensioned and configured for passing through the passageway of the sleeve members. 
     The present invention is also directed to a catheter comprising body member having a lumen; and plurality of sleeve members disposed on the body member, each sleeve member having a passageway therethrough. 
     A catheter, according to the present invention, comprises generally rigid body member having a lumen; balloon member disposed on the body member and communicating with said lumen; and plurality of generally flexible sleeve members disposed on the body member, each sleeve member having a passageway therethrough. 
     The present invention also is directed to a catheter which comprises body member having a lumen; device member disposed on the body member; and plurality of sleeve members disposed on the body member, each sleeve member having a passageway therethrough. The device member can be a stent or a container having a chamber for containing a drug. 
     Also, the present invention is directed to a method of using a catheter comprising providing a catheter including body member having a lumen; balloon member disposed on the body member and communicating with the lumen; and plurality of sleeve members disposed on the body member, each sleeve member having a passageway therethrough; selectively passing a guidewire through the passageways of the sleeve members, the guidewire being disposed in a body cavity, so as to position the catheter at a desired location within the body cavity; and selectively inflating the balloon and withdrawing the catheter from within the body cavity. 
     The present invention is also directed to a method of using a catheter comprising providing a catheter including body member having a lumen; device member disposed on the body member; and plurality of sleeve members disposed on the body member, each sleeve member having a passageway therethrough; selectively passing a guidewire through the passageways of the sleeve members, the guidewire being disposed in a body cavity, so as to position the catheter at a desired location within the body cavity; and selectively operating the device member within the body cavity. 
     According to one preferred embodiment wherein the device member comprises a container having a chamber containing a drug, the method further comprises releasing the drug from the chamber. Alternatively, wherein the device member comprises a stent, the method further comprises releasing the stent within the body cavity. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention is described in detail below with reference to the drawings wherein: 
     FIG. 1A is a cross-sectional view of a balloon catheter according to the prior art taken along the midsection of the balloon, wherein the balloon lumen is in the center and the guidewire lumen is eccentric to the balloon but in the shaft of the catheter. 
     FIG. 1B is a cross-sectional view of a balloon catheter according to the prior art wherein the balloon lumen is in the center and the guidewire lumen is eccentric to the shaft. 
     FIG. 1C is a cross-sectional view of a bi-lumen catheter according to the prior art wherein the guidewire lumen and the balloon lumen are concentric to the shaft of the catheter. 
     FIG. 1D is a cross-sectional view of the balloon catheter according to the prior art wherein the guidewire lumen and the balloon lumen are in a symmetrical axis to each other. 
     FIG. 2A is a side view of a balloon catheter according to the prior art wherein the guidewire sleeve exits proximally out of the balloon about ⅔ the length of the catheter. 
     FIG. 2B is a side view of a balloon catheter according to the prior art wherein the guidewire sleeve exits at the proximal tip of the balloon. 
     FIG. 2C is a side view of a balloon catheter according to the prior art wherein the guidewire sleeve exits adjacent but prior to the proximal end of the catheter. 
     FIG. 2D is a side view of another embodiment of a balloon catheter according to the prior art wherein the guidewire sleeve exits at the proximal end of the catheter. 
     FIG. 3A is a side view of an embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of four spaced apart sleeve members and wherein the sleeve member through the balloon is the longest. 
     FIG. 3B is a side view of another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of four spaced apart sleeve members wherein the guidewires lumen is eccentric to the balloon lumen and exits proximal to the balloon. 
     FIG. 3C is a side view of an yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of four spaced apart sleeve members which are more closely spaced than the sleeve members in FIG. 3A or  3 B. 
     FIG. 3D is a side view of an still another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of three spaced apart sleeve members and wherein the sleeve member through the balloon is the longest. 
     FIG. 3E is a side view of an still yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of five different sized and differently spaced apart guidewire sleeve members. 
     FIG. 4A is a side view of an embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of three spaced apart sleeve lumens located along and extending beyond the ends of the balloon and wherein the guidewire lumen is eccentric to the balloon. 
     FIG. 4B is a side view of an an embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of three spaced apart sleeve lumens and wherein two sleeve lumens are positioned distally of the balloon and the remaining sleeve lumen is positioned in the region of the balloon and wherein the guidewire lumen is eccentric to the balloon. 
     FIG. 4C is a side view of an yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of three spaced apart sleeve lumens positioned distally of the balloon and wherein the guidewire lumen is eccentric to the balloon. 
     FIG. 4D is a side view of still yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of three spaced apart sleeve lumens positioned proximally of the balloon. 
     FIG. 6 is a side view of an embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of four spaced apart sleeve members and wherein the sleeve member through the balloon is the longest. 
     FIG. 7 is a side view of a generally rigid tube for use with the balloon catheter of FIG.  8 . 
     FIG. 8 is a side view of an yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of two spaced apart sleeve members and wherein the balloon is disposed on a flexible sheath which is coupled to the generally rigid tube of FIG. 7 so that the flexible portion is distal and the rigid portion is proximal. 
     FIG. 9 is a side view of an still another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of two spaced apart sleeve members and the catheter shaft includes proximal and distal apertures for perfusion of blood during angioplasty. 
     FIG. 10 is a side view of an still yet another embodiment of a balloon catheter according to the present invention wherein the catheter shaft has microporous holes disposed along the shaft for drug delivery. 
     FIG. 11 is a side view of an yet another embodiment of a balloon catheter according to the present invention wherein the guidewire sleeve is formed of two spaced apart sleeve lumens and wherein the balloon carries a stent. 
     FIG. 12 is a side view of the balloon catheter of FIG. 11 having different sized sleeve members and further including a sheath on the stent for removal and inflation. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In the description which follows, any reference to direction or orientation is intended primarily and solely for purposes of illustration and is not intended in any way as a limitation to the scope of the present invention. Also, the particular embodiments described herein, although being preferred, are not to be considered as limiting of the present invention. 
     An invention is hereby described which applies the laws of physics and also the general principle of train on a track. A train moves on a track with multiple wheels which are positioned at equal distances form the engine. The present invention applies this principle to a catheter by having multiple entry points and exit points of a catheter body for the passage of a guidewire. 
     From physics it is known that the force required to push an object on top of another depends on the surface area of coverage and the nature of the radial coverage that enables a longitudinal force to be transmitted while the object is being pushed on top of the other object. 
     Various known balloon catheter configurations are shown in FIGS. 1A-1D and FIGS.  2 A— 2 D. In FIG. 1A, a balloon  10  is shown with an internally and centrally positioned balloon lumen  12  and a guidewire lumen  14  which is in the shaft of the catheter but eccentric to the balloon  10 . In the catheter shown in FIG. 1B, the balloon lumien  16  is centrally located within the balloon  20  and the guidewire lumen  18  which is eccentric to the shaft and the balloon  20 . The catheter shown in FIG. 1C has a balloon  22  with internal guidewire lumen  24  and surrounding balloon lumen  26 . Both guidewire lumen  24  and balloon lumen  26  are concentric to the shaft of the catheter. In FIG. 1D, the guidewire lumen  30  and balloon lumen  34  are positioned within balloon  36  so that the balloon lumen  34  is centrally positioned and the guidewire lumen  30  is outside of the balloon lumen  34 . 
     In reference to FIG. 2A, a known catheter  38  includes a catheter body  40  with a distally positioned balloon  42 . A guidewire lumen  44  for a guidewire (not shown) extends from the distal end of the catheter but exits before the full length of the catheter  38 . In the catheter  46  of FIG. 2B, the guidewire lumen  48  extends through the balloon  50  and exits at the proximal end of the balloon  50 . In another known catheter  52  shown in FIG. 2C, the guidewire lumen  54  extends through the balloon  56  and extends closely to the proximal end of the catheter body  58 . As shown in FIG. 2D, the catheter  60  has a catheter body  62 , a balloon  64  and a guidewire lumen that extends the length of the balloon  64 . 
     Referring to FIG. 3A, a balloon catheter  100  according to the present invention has a catheter body  102  and a distal balloon  104 . Coupled to the catheter body  102  are four sleeve members including the longest member  106  that spans the balloon  104 . The other three sleeve members  108  are equal in size and spaced apart from each other and sleeve member  106 . Each sleeve member  106  and  108  has an entry port  110  which is located at the most distal end of the sleeve member and an exit port  112  located at the proximal end of the respective sleeve member. Thus the sleeve members provide multiple points of entry for the guidewire (not shown) and corresponding multiple points of exit for the guidewire. The exit port  112  for the largest sleeve member  106  is proximal to the proximal end of the balloon  104  either concentric or eccentric to the balloon  104 . Alternatively, the other ports of exit  112  can be located at various distances along the length of the catheter  100 . These ports of entry and exit can be located at various predetermined locations. Various desired predetermined configurations of displacements of the sleeve members  106  and  108  can be utilized as well as various lengths of the different sleeves. These points n run along the entire length of the catheter or can run only in the distal part of the catheter. 
     Depending on the lesion morphology and also the tortuosity of the lesion, the length of the catheter which runs on the guidewire can be selected. 
     In one preferred embodiment, a catheter can have four points or five points of entry and five points of exit. In an alternative embodiment, the catheter can have seven points of entry and seven points of exit. 
     Depending on the length of the coverage of each, the exposed segments of the catheter between the sleeve members act as wheels. Hence the catheter of the present invention provides multiple wheels that guide the catheter. 
     The first point of entry is ideally located at the tip of the balloon and can run concentric to the balloon axis or can run eccentric to the balloon axis, the first point of exit is located just after the balloon or a short distance proximal to it. The second point of entry is located at a distance greater than the first point of entry and subsequent exit at second pint. The distance between the first point of exit and the second point of entry is the exposed part of the wire in the body of the catheter. This exposed part of the wire is called the “wire segment”. The distance between the second point of entry and the second point of exit is called the “catheter segment”, the wire segment land the catheter segment can alternate along the entire length of the catheter or only on the distal ⅓ of the catheter. 
     A catheter is also described wherein the first point of entry is located distal to the location of the balloon such that the wire does not pass inside the lumen of the balloon. In such a case the catheter shaft that has “wire segments” and “catheter segments” is taken at the site of the lesion, the wire pulled back such that it is proximal to the balloon and the balloon is then dilated at the site of the lesion. 
     Referring to FIG. 3B, the catheter  114 , similar to that shown in FIG. 3B, has a balloon  116  and four sleeve members  118  and  120  which are equally spaced apart. Sleeve member  118  is the longest and spans the balloon  116 . Unlike catheter  100  wherein sleeve member  106  is a separate tubular structure coupled to catheter body  102 , sleeve member  118  in catheter  114  can be formed as part of the catheter body  122 . In the alternative embodiment of FIG. 3C, the catheter  124  has four sleeve members  126  and  128  that are more closely spaced than in FIGS. 3B and 3C. 
     In yet another alternative embodiment, catheter  130  in FIG. 3D includes three sleeve member  132  and  134  which are spaced at different intervals along the catheter body  136 . Still another embodiment  138  shown in FIG. 3E has five different spaced and different sized sleeve members  140 ,  142 ,  143 ,  144  and  145 . The catheter  138  has a catheter body  146  that at its proximal end has a Y-lumen configuration  148 . 
     Turning to, the catheter embodiment  150  shown in FIG. 4A, a catheter body  152  has a balloon structure  154  (shown schematically) at the distal end of the catheter  150 . Three equally sized and spaced sleeve members  156  are positioned distally and span the length of the half balloon  154 . In the alternative embodiments  158  and  160  illustrated schematically in FIGS. 4B and 4C, the balloon  154  is located on the catheter body  152  closer to the proximal end of the catheters  158  and  160 . In the embodiment  162  of FIG. 4D, the balloon  164  is positioned distally of the sleeve members  166  that receive guidewire  168  that passes through, the passageways of each sleeve member  166 . In the exemplary embodiment of FIG. 4D, the guidewire  168  has a curled distal end  170  but straight configurations can also be employed with the catheters of the present invention. 
     Referring to FIG. 6, a catheter  172  includes a  174  and four sleeve members  176 ,  178 ,  180  and  182  which are coupled to a shaft  184  that has a larger diameter proximal end portion. FIGS. 7 and 8 illustrate two parts of balloon catheter  186  that can be combined to form the catheter. The structure of FIG.  7 . is a generally rigid tube  188 . In FIG. 8, the guidewire sleeve is formed of two separate members  188  and  190  that are connected to a balloon lumen  192  that allows for inflation of balloon  194 . The balloon lumen  192  is a generally flexible sheath which can be coupled to the generally rigid tube shown in FIG.  7 . After combining the components of catheter  186 , the flexible portion is distal and the rigid portion is proximal. 
     In the embodiment of FIG. 9, the balloon catheter  196  has a guidewire sleeve that is formed of two spaced apart sleeve members  198  and  200 . Included on the catheter shaft  202  are proximal and distal apertures  204  that allow for the perfusion of blood during angioplasty. In the catheter  206  shown in FIG. 10, microporous holes  208  are provided along the length of the catheter shaft  210 . Guidewire lumens (not shown) according the present invention can be attached to the shaft  210  at various locations along the catheter body. 
     In general, each sleeve member of the various embodiments disclosed and described herein has an entry port  110  and an exit port  112  as shown and discussed in connection with the catheter  100  of FIG.  3 A. Also, each sleeve member has a passageway to accommodate the passage of the guidewire. The embodiments herein demonstrate that various sized and spaced sleeve members can be employed to allow for passage of a guidewire. Also, the guidewire lumens can be attached or coupled to the catheter shaft by various known methods of attachment. Alternatively, the guidewire lumens can be formed integrally with the catheter body. 
     The invention also covers other interventional devices apart from the balloon to include stents, mounted on balloons or otherwise, drug delivery devices where the media can be delivered distal to the balloon or proximal to the balloon. Thus the catheter of the present invention allows for improved pushability and control over that available with known catheters. The balloon can be made of compliant, semi-compliant or a non-compliant polymeric material, or a combination of a polymeric material. The body member can be made of metal, plastic or a combination of both. The sleeve member is preferably made of plastic, polymeric material. In use, the balloon can be inflated with saline or a contrast fluid as is known by those skilled in the art. 
     In the embodiment illustrated in FIG. 11, a balloon catheter  210  includes a balloon  212  disposed on a catheter shaft or balloon lumen  214  which has guidewire lumens  216  and  218 . A stent  220  is positioned on and carried by the balloon  212 . After the balloon  212  is located at the preferred or desired site within a blood vessel, the stent can be released, the balloon deflated and the catheter  210  removed. In the embodiment shown in FIG. 12, the catheter  222  also includes a sheath on the stent for removal and inflation. Different sized and positioned guidewire lumens  224  and  226  can be used with balloon  228 . Drug delivery catheters  230  are shown in FIGS. 13 and 14 which can be used with the guidewire lumens (not shown) of the present invention. In FIG. 13, the catheter  230  is shown as including a catheter shaft  232  with a distally positioned device member  234  which is shown in a closed configuration in FIG.  13  and in an open and drug released configuration in FIG.  14 . The device member  234  has a hollow chamber inside for storing a desired drug for delivery to a location within a body cavity such as a blood vessel. Alternatively, the device member  234  can store and delivery other medical devices suitably sized so that they can be carried within device member  234 . The drug within device member  234  can be discharged by saline fluid which can be injected into the device member  234  through a suitably provided lumen within catheter shaft  232 . Alternatively mechanical release systems can also be employed. 
     While the present invention has been described and illustrated herein with respect to the preferred embodiments thereof, it should be apparent that various modifications, adaptations and variations may be made utilizing the teachings of the present disclosure without departing from the scope of the invention and are intended to be within the scope of the present invention.