Patent Abstract:
An elongated hollow tube guiding catheter forming a portion of a guiding catheter includes a proximal end, distal end, and distal section. The distal section includes a curved section and a straight section. The curved and straight sections are shaped for facilitating introduction and retention of the catheter into the ostium of a renal artery. The system includes a dilator inserted into the catheter hollow tube with a curved distal section of the dilator opposingly extending opposite the curved distal section of the guiding catheter hollow tube. The guiding catheter includes a side arm positioned near the guiding catheter&#39;s proximal end with a multi-way stop cock fixedly attached onto a proximal end of the side arm tube.

Full Description:
FIELD OF USE 
     This invention is in the field of methods and devices for accessing the renal arteries for the treatment of high blood pressure. 
     BACKGROUND OF THE INVENTION 
     There are now several catheters being developed by several different companies whose goal is to perform renal nerve denervation to reduce the blood pressure for hypertensive patients. Therefore, it will become increasingly important over the next several years to create improved means for renal denervation catheters to access the renal arteries. 
     The current practice for accessing the renal arteries is to first use an arterial access needle puncture at the groin, and then a guide wire is placed through that needle into the femoral artery. The needle is then removed while the guide wire remains in place in the femoral artery at the groin. An introducer sheath with dilator would then be advanced over the guide wire and into the lumen of the femoral artery. The dilator and the guide wire would then be removed and a guiding catheter would be advanced through the introducer sheath until its distal end would be placed into a renal artery. A catheter for renal denervation could then be advanced through the guiding catheter and it would be used to kill a section of the renal nerves that surround the renal artery thus permanently lowering the blood pressure of a patient that is hypertensive. 
     The renal denervation catheters require a fairly large diameter guiding catheter; typically 6, 7 or 8 French size. Since the outer diameter of the sheath through which the guiding catheter is inserted is typically 2 to 3 French sizes larger than the outer diameter of the guiding catheter, a fairly large diameter hole must be made through the wall of the femoral artery. These larger size holes can lead to excessive bleeding at the groin after the guiding catheter and the sheath are removed. 
     At this time, all guiding catheters designed for accessing the renal arteries terminate at their proximal end with a Luer fitting. To perforin an intra-arterial procedure with any existing guiding catheter, it is necessary to attach a Tuohy-Borst “Y” adaptor onto the Luer fitting at the guiding catheter&#39;s proximal end. The introducer sheath and Tuohy-Borst “Y” adaptor are each components that require additional time for the interventional cardiologist to properly place, and they add to the cost of performing intra-arterial procedures. Also, the introducer sheath through which the guiding catheter is inserted typically must have a three-way stopcock attached to a Luer fitting on a side arm tube that is located near the proximal end of the introducer sheath. The additions of a Tuohy-Borst “Y” adaptor to the guiding catheter and adding a three-way stopcock to the side tube of the introducer sheath adds additional cost and time to any procedure for accessing the renal artery. If a means for accessing the renal artery could be accomplished without requiring an introducer sheath and without requiring the additional parts of a Tuohy-Borst “Y” adaptor and a three-way stopcock, the procedure could be done in less time and at a lower cost. 
     In U.S. Pat. No. 5,389,090, Fischell et al describe an improved guiding catheter that is particularly useful for accessing the coronary arteries. However, there are no specific features of that invention that are specifically devoted for improved access for the renal arteries. Specifically, the invention described in the &#39;090 patent does not teach markings on the shaft of the guiding catheter to assist in the placement of that guiding catheter into the renal arteries. The &#39;090 patent also fails to teach the importance of a side arm tube that lies in the same plane as does the curve at the distal section of the guiding catheter, which feature enables the operator to have the correct azimuth angle for placement of the distal end of the guiding catheter into and through the ostium of the renal artery. Still further, the &#39;090 patent fails to teach a three-way stopcock formed integral with the side arm tube at the guiding catheter&#39;s proximal end that precludes the need for the operator to open a separate package to attach that device to the guiding catheter. A guiding catheter design that would not require the use of an introducer sheath and would have a Tuohy-Borst fitting and a three-way stopcock each formed integral with the guiding catheter at its proximal end would result in savings of both time and cost for the procedure to access the renal arteries. 
     SUMMARY OF THE INVENTION 
     The present invention is an improved guiding catheter designed explicitly to access the renal artery. This renal artery guiding catheter eliminates the need for: 1) an introducer sheath; 2) a separate Tuohy-Borst “Y” adaptor; and 3) a separate three-way stopcock. By this means, the present invention provides a means and method for reducing the time and expense for performing renal artery procedures. Furthermore, the guiding catheter with straightening dilator as described herein allows the hole in the wall of the femoral artery to be approximately 2 to 3 French sizes smaller in diameter as compared to the hole that would be created if an introducer sheath is also used, thus decreasing the possibility of bleeding at the groin. Still further by making the curve at the distal section of the shaft of the guiding catheter to be coplanar with the guiding catheter&#39;s side arm tube, the interventional cardiologist can more easily place the distal end of the guiding catheter into and through the ostium of the renal artery. Additionally, explicit markings along the tube of the guiding catheter allow the interventional cardiologist to more accurately place the distal end of the guiding catheter into the aorta prior to removing the dilator and guide wire from the guiding catheter. Still further, the shape of the distal section of this special guiding catheter allows entry of a straight section at the distal end of the guiding catheter to be advantageously placed into the renal artery irrespective of the angle that the renal artery makes with the aorta. 
     The advantages of the present invention are accomplished by utilizing a dilator that has a curved distal section placed 180 degrees opposite from the curve at the guiding catheter&#39;s distal section, which opposing curve of the dilator is used to initially straighten the curved distal section of the renal artery guiding catheter as it is advanced through the patient&#39;s arterial system. In this way, the dilator straightens the guiding catheter so that it can be used like an introducer sheath to enter the femoral artery by being advanced over a previously placed guide wire. Once the distal ends of the guide wire, dilator and guiding catheter are placed just beyond the ostium of a renal artery, the dilator and guide wire are withdrawn which allows a distal section of the guiding catheter to assume its normally bent shape. By pulling the guiding catheter back down the aorta, the cardiologist can then place the guiding catheter&#39;s distal end into and through the ostium of either the right or the left renal artery. Any one of several well-known procedures can then be performed including denervation of the renal nerves, angiography, balloon angioplasty, and atherectomy or stent placement. The unique design of the distal section of the guiding catheter allows a short straight section at that curves distal end to be placed into the renal artery irrespective of the angle that the renal artery makes with the aorta. This design feature precludes the need for making a variety of shapes for different guiding catheters that would otherwise be required to access renal arteries that make different entry angles relative to the aorta. Another means for expressing this advantage is that only one product code is required to be manufactured by the company that makes this product, which product will include a guiding catheter having a distal straight section that is able to readily enter a renal artery irrespective of the angle that that renal artery makes with the aorta. A marketing advantage for the present invention is that the manager of a cath lab will prefer to have a reduced inventory of guiding catheters to access the femoral artery. Therefore, having only a single product code would provide that desired goal of a reduced inventory for this renal artery guiding catheter product. 
     The guiding catheter of the present invention utilizes a Tuohy-Borst fitting that is formed integral with the guiding catheter and a side arm tube all placed at the guiding catheter&#39;s proximal end. This capability obviates the need for attaching a separate Tuohy-Borst “Y” adaptor at the guiding catheter&#39;s proximal end to accomplish arterial access with minimum bleeding. The guiding catheter&#39;s Tuohy-Borst fitting could be tightened around guide wires or the shaft of catheters that are advanced through the guiding catheter. 
     The side arm tube, also located at the proximal end of the guiding catheter. could terminate in a female Luer fitting as described in the &#39;090 patent, or more advantageously it could have a three-way stopcock formed integral with the side arm tube at the tube&#39;s proximal end. That three-way stopcock could be attached to a manifold for the introduction of saline solution, contrast medium, medications or a solution such as alcohol, which liquids can be used in the procedure for renal denervation. Thus, the Tuohy-Borst fitting with side arm at the guiding catheter&#39;s proximal end eliminates the need for a separate Tuohy-Borst “Y” adaptor and the three-way stopcock formed integral at the proximal end of the side arm tube eliminates the need to have that device separately attached to a Luer fitting at the proximal end of the side arm tube. Still further, the direction of the side arm tube relative to the guiding catheter tube being the same as the direction of the curved distal section of the guiding catheter allows the interventional cardiologist to easily find the correct azimuth angle around the circumference of the aorta for the easy placement of the distal end of the guiding catheter through the ostium of the renal artery. 
     Another novel feature of the present invention are markings on the outer cylindrical surface of the elongated hollow tube that constitutes most of the length of the guiding catheter. These markings are set at the distance to advance the guiding catheter through the patient&#39;s arterial system so that the distal end of the guiding catheter will be situated approximately 10±5 cm beyond the ostia of the renal arteries depending on the height of that patient. This can be accomplished because the distance from the skin at the groin entry site for the guiding catheter to the point at a 10±5 cm distance beyond the ostium of either renal artery is highly dependent upon how tall a particular patient would be. 
     Thus, it is an objective of the present invention to allow placement of a renal artery guiding catheter to have its distal end placed into the renal artery without requiring insertion of the guiding catheter through an introducer sheath thus allowing a smaller hole to be made in the wall of the femoral artery. 
     Another objective of this invention is to eliminate the need for a separate Tuohy-Borst “Y” adaptor by having a Tuohy-Borst fitting formed integral with the guiding catheter at the guiding catheter&#39;s proximal end. 
     Still another objective of the present invention is to have a side arm tube that has a three-way stopcock formed integral at the proximal end of that side arm tube thus eliminating the need for a separately attached three-way stopcock. 
     Still another objective of the present invention is to have a side arm tube that extends outward from the shaft of the guiding catheter so as to be co-planar with plane of the guiding catheter&#39;s curved distal section and also to be extending in the same direction as that curved distal section of the guiding catheter thus assisting the interventional cardiologist in placing the distal end of the guiding catheter into and through the ostium of a renal artery. 
     Still another objective of the invention is to use a guide wire and a dilator within a guiding catheter for placement of the guiding catheter without requiring an introducer sheath. 
     Still another objective of the invention is to utilize a dilator having a curved distal section that when placed inside a guiding catheter that has a curved dilator section in the opposite direction causes the dilator-guiding catheter assembly to be essentially straight for easy insertion through the arterial system. 
     Still another objective of the invention is to reduce the cost and time required for performing arterial interventional procedures for accessing the renal arteries by eliminating the need for an introducer sheath and by having a Tuohy-Borst fitting and a three-way stopcock each formed integral with the guiding catheter at its proximal end. 
     Still another objective of the invention is to reduce the probability of bleeding at the skin where the guiding catheter enters the femoral artery by eliminating the need for an introducer sheath to have the guiding catheter gain access to the patient&#39;s arterial system. 
     These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading of the detailed description of this invention including the associated drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a guiding catheter system including a guide wire, straightening dilator and a guiding catheter with Tuohy-Borst fitting and a three-way stopcock mounted onto the side arm tube of the guiding catheter. 
         FIG. 2  is a side view of the guiding catheter showing its curved distal section that occurs when the oppositely curved dilator is withdrawn. 
         FIG. 3  is a side view of a straightening dilator illustrating its curved distal section that curves opposite in its direction compared to the curved distal section of the guiding catheter into which the dilator is inserted so that the combination of both curves, as seen in  FIG. 1 , provides a comparatively straight distal section of the combined guiding catheter and straightening dilator for improved insertion through the patient&#39;s arterial system. 
         FIG. 4  is an enlarged partial longitudinal cross section of the proximal end of the guiding catheter at section  4 - 4  of  FIG. 2 . 
         FIG. 5  is an enlarged transverse cross section of the Tuohy-Borst fitting at section  5 - 5  of  FIG. 1 . 
         FIG. 6A  is a cross section of a Tuohy-Borst gland with a half “O” ring with the gland in a fully open position. 
         FIG. 6B  is a cross section of a Tuohy-Borst gland with a half “O” ring with the gland in a fully closed position. 
         FIG. 7  illustrates the initial position of the distal ends of the guide wire, dilator and guiding catheter as they are initially inserted into the aorta just beyond the ostia of the left and right renal arteries. 
         FIG. 8  shows the initial position of the distal section of the guiding catheter within the aorta immediately after the guide wire and dilator have been withdrawn. 
         FIG. 9  shows the distal end of the guiding catheter placed into the renal artery after it has been pulled back from the position shown in  FIG. 8 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 1 ,  2  and  3  illustrate the guiding catheter system  10  having a guiding catheter  12  with an elongated tube  11  with a distal section  11 A having a distal end  19 E, a Tuohy-Borst fitting  20 , a side arm tube  14  with a three-way stopcock  30  at its proximal end, and a guide wire  15  and a straightening dilator  16  each situated within the tube  11 . It should be noted that the configuration of  FIG. 1  is how this guiding catheter system  10  would be placed through the patient&#39;s skin at the groin, then into the femoral artery and then advanced through the aorta and beyond the renal arteries as shown in  FIG. 7 . 
     As best seen in  FIG. 2 , the guiding catheter  12  has an elongated cylindrical tube  11  with a curved distal section  11 A ending at point  19 D where a short straight section  19 S begins. The straight section  19 S extends to its distal end  19 E. It should be noted that the angle “a” that the centerline of the straight section  19 S makes with the centerline of the straight section of the tube  11  should optimally be about 30 degrees. This angle “a” makes it possible for the straight section  19 S to have a straight entry into a renal artery even if that renal artery makes a downward angle of as little as 30 degrees relative to the aorta. This is shown in greater detail with the assistance of  FIG. 9 . 
     The tube  11  also has markings  11 B,  11 C,  11 D,  11 E,  11 F and  11 G that indicate points on the tube  11  corresponding to how far the interventional cardiologist should advance the system  10  into the patient&#39;s arterial system depending on the height of the patient. The single line mark  11 C indicates the extent to which the tube  11  should be advanced if the patient is approximately 5 feet tall. The number “5” (which is element  11 B) reminds the cardiologist that the mark  11 C corresponds to the point on the patient&#39;s skin at the groin to which the tube  11  should be advanced if the patient is approximately five feet tall. If the patient is 6 feet tall, as indicated by the “6” of element  11 E, then the three lines of element  11 F indicate the point to which the tube  11  should be advanced to place the mark  11 F at the skin of the patient at his/her groin if that patient is six feet tall. The marks  11 D and  11 G correspond respectively to patient heights of five feet, six inches and six feet, six inches. For patient heights corresponding to a position between these markers, the cardiologist can set the depth to which the tube  11  is inserted through the patient&#39;s skin to be between the appropriate markers. For example, for a woman whose height is five feet, three inches, the tube  11  would be advanced through the patient&#39;s skin at her groin with the tube  11  placed at her skin halfway between the one line of mark  11 C and the two lines of mark  11 D. The approximate distance between each adjacent pair of the marks  11 C,  11 D,  11 F and  11 G would be 5±2 cm. 
       FIG. 2  also shows a proximal section of the guiding catheter  12  that has a threaded base  21 , a threaded nut  22  and a side arm tube  14  that has a three-way stopcock  30  at its proximal end. When the marker  27  on the threaded base  21  is aligned with the marker  28  on the threaded nut  22 , then the curved distal sections of the tube  11  and the dilator  16  will be 180 degrees in opposite directions and the distal curved sections  11 A and  16 A will act together to create a generally straight guiding catheter system  10  as shown in  FIG. 1 . This function will be described in greater detail with the assistance of  FIGS. 3 ,  4  and  5  below. 
     As shown in  FIG. 3 , the dilator  16  has a distal curved section  16 A that is connected to the straight section  16 S at the point  16 D, and the straight section  16 S terminates at a tapered distal end  16 E. The dilator tube  16  is designed to fit snugly around the guide wire  15 . The dilator tube  16  is designed to be advanced over the guide wire  15  and within the lumen  13  of the guiding catheter tube  11  so that the assembly of the guiding catheter system  10  (as shown in  FIG. 1 ) can be in a straightened condition so that it can be readily advanced through the patient&#39;s arterial system. All the sections of the dilator tube  16  are designed to fit slideably within the interior lumen  13  of the guiding catheter tube  11 . It should be understood that there could be only one bend, or two or more bends at this distal section of the dilator tube  16  and the curved section  11 A of the tube  11 . The dilator also has at its proximal end a handle  17  with a cone  17 A having a key  17 B for mating with the keyway  26  of the threaded nut  22  of the Tuohy-Borst fitting  20  as seen in  FIGS. 4 and 5 . 
     As seen in  FIGS. 1 ,  2  and  4 , the guiding catheter  12  has a Tuohy-Borst fitting  20  that is integrally attached as a one-piece construction at the proximal end of the catheter tube  11 . As best seen in  FIG. 4 , the Tuohy-Borst fitting  20  has a threaded base  21 , a side arm  14  having a three-way stopcock  30  at its proximal end, a threaded nut  22  with conical entry lumen  23 , a soft elastomer gland  24  and a comparatively hard washer  25 . As seen in  FIG. 4 , when the nut  22  is not tightened down, the gland  24  is not compressed and the lumen  23  is in fluid communication with the lumen  13  of the elongated tube  11  and the lumen  18  of the side arm tube  14 . When the nut  22  is screwed into the threaded base  21 , the washer  25  compresses the soft elastomer gland  24  which can then fit snugly around a guide wire  15  or a dilator  16  or the shaft of a renal artery denervation catheter or a stent delivery catheter. Furthermore, when the nut  22  is fully screwed onto the threaded base  21 , the central lumen of the gland  24  can be totally closed so that no blood will leak out of the guiding catheter&#39;s proximal end even if there is no guide wire  15  or catheter tube  11  placed through that gland  24 . 
     As shown in  FIGS. 1 and 2 , the threaded base  21  has an indicator mark  27  which, when aligned with an indicator mark  28  on the nut  22 , informs the operator that the tube  11  and the dilator  16  are positioned so that together they form a straight distal end section as shown in  FIG. 1 . It is also conceived that a straight dilator with a comparatively stiff distal section  16 A could be used to straighten out the curved end section  11 A of the guiding catheter  12  as is shown in  FIG. 1 . The stiffer the distal section of such a dilator  16 , the straighter would be the distal section of the assembly of the dilator  16  with the guiding catheter  12 . Of course, when such a straight (or curved) dilator would be pulled out, the distal section  11 A of the guiding catheter  12  would assume its proper shape as generally illustrated in  FIG. 2 . 
       FIG. 4  shows the three-way stopcock  30  fixedly attached to the side arm tube  14  by means of the connecting tube  31 . Specifically,  FIG. 4  shows the stopcock  30  with an operating lever  34  in an intermediary position. For an external fluid source to connect to the lumen  18  by means of the Luer fitting  33 , the lever  34  would be placed over the Luer fitting  32 . For a fluid source to deliver fluid into the lumen  18  via the Luer fitting  32 , the lever  34  would be placed over the Luer fitting  33 . To close the side arm tube  14  from any access through either Luer fitting  32  or  33 , the lever  34  would be placed over the connecting tube  31 . It should be understood that a two-way or a four-way stopcock could be used instead of the three-way stopcock  30  shown in  FIGS. 1 and 4 . In general, a multi-way stopcock could be advantageously formed integral at the proximal end of the side arm tube  14 . 
       FIGS. 4 and 5  also show a keyway  26  in the nut  22  which is adapted to mate with the key  17 B of the dilator handle  17 . When the marks  27  and  28  are aligned as shown in  FIGS. 1 and 2 , the alignment formed by keyway  26  and the key  17 B guarantees that the bends in the distal sections of the guiding catheter tube  11  and the dilator  16  oppose each other so as to straighten the guiding catheter system  10  as shown in  FIGS. 1 and 7 . In this position, the guiding catheter  12  with dilator  16  in place can be readily advanced over the guide wire  15  until the distal end  19 E of the guiding catheter tube  11  is located just beyond the ostium of the renal artery to which access is desired as is shown in  FIG. 7 . The dilator  16  and guide wire  15  can then be withdrawn and the guiding catheter  12  will assume its desired distal section shapes as shown in  FIGS. 8 and 9 . The cardiologist can then place the guiding catheter&#39;s distal end  19 E through the ostium of a renal artery as shown in  FIG. 9 . 
     It is important to note that the guiding catheter system  10  should not be stored or packaged in the configuration as shown in  FIG. 1 . If that were to be done, then in time, and particularly if there is any exposure to an elevated temperature, the final distal section curve of the catheter tube  11  could be reduced and that would not be the optimum curve which is most suitable for accessing the renal arteries. If the package containing the system  10  was sold as shown in  FIG. 1 , then the final curvature at the distal section of the tube  11  could be considerably reduced as compared to the curve shown in  FIG. 2 . Therefore, the present invention conceives of the fact that the elements of the guiding catheter system  10  should be separated into a kit that at least allows the guiding catheter tube  11  and the dilator tube  16  to remain apart until the guiding catheter system  10  is assembled prior to insertion of the guiding catheter system  10  into the patient&#39;s arterial system. 
       FIGS. 6A and 6B  illustrate an alternative design for the soft elastomer gland of a Tuohy-Borst fitting  20 . Specifically,  FIG. 6A  shows a gland  70  in its open (not compressed) state. The gland  70  has a generally cylindrical interior surface  71 A on which is placed a half “O” ring  72 A. When the nut  22  of  FIG. 4  is tightened, the gland  70  can be deformed to the shape shown in  FIG. 6B  wherein a highly curved interior surface  71 B is formed with the half “O” ring  72 B being distorted to a closed or nearly closed position as shown in  FIG. 6B . 
       FIGS. 7 ,  8  and  9  illustrate how the present invention would be used to effectively access either one or both of the renal arteries  82  and  83 .  FIG. 7  is a posterior view of certain body parts showing the aorta  80 , the left kidney  81 , the left renal artery  82 , the right renal artery  83 , the right kidney  84  and also the guiding catheter tube  11  in its straightened condition due to the insertion of the dilator  16  which was previously advanced with the guiding catheter  12  over the guide wire  15 . It should be noted that the right renal artery  83  is typically longer than the left renal artery  82  due to the placement of the inferior vena cava between the aorta  80  and the right kidney  83 . The distal end  85  of the guiding catheter tube  11  is shown in a position that is a length “D” beyond the centerline  85  of the ostia of the left and right renal arteries. An optimum distance for this distance D would be 10±5 cm. Thus, even if a patient of a particular height had his or her renal artery centerline further away from the entry of the guiding catheter system  10  at the patient&#39;s groin than that which is indicated by the marks  11 B to  11 H on the tube  11  (as shown in  FIGS. 1 and 2 ) the distal end  19 E of the tube  11  would still lie distinctly above the renal artery centerlines. It should be noted that the total length of the renal artery catheter  12  could optimally be approximately 60 cm. The distance from the catheter&#39;s distal end  19 E to the first mark  11 C (of  FIGS. 1 and 2 ) being about 35±5 cm and the length from the distal end  19 E to the mark  11 G being approximately 50±5 cm. It should be noted that the mark  11 C corresponds to a patient height of five feet and the mark  11 G corresponds to a patient height of six feet, six inches. These lengths have been chosen so that at least a length of approximately 10 cm will typically be situated outside of the patient&#39;s skin at the groin irrespective of the patient&#39;s height. This 10 cm length provides the interventional cardiologist with additional margin for an extremely rare case when the renal arteries are even further away from the femoral artery entry point of the guiding catheter system  10  at the skin near the patient&#39;s groin. 
     After the guide wire  15  and the dilator  16  are withdrawn from the guiding catheter tube  11 , the curved distal section  11 A of the tube  11  would be situated as shown in  FIG. 8 . In this position, the distal end  19 E of the curved distal section  11 A of the catheter tube  11  would move against the wall of the aorta  80  opposite the wall where the tube  11  is situated. When that condition has been obtained, the cardiologist would typically inject contrast medium (not shown) through the three-way stopcock  30  to visualize the geometry of the ostium of the right renal artery  83 . After that is accomplished, the cardiologist would pull back the proximal end of the guiding catheter  12  until the straight section  19 S at the distal end of the curved distal section  11 A enters into and through the ostium of the right renal artery  84  as shown in  FIG. 9 . It should be understood that the distal section  11 A of the tube  11  would be made radiopaque so that it can be readily visualized by the interventional cardiologist using conventional image intensified fluoroscopy. 
     A unique feature of the present invention is that the interventional cardiologist could always get the straight section  19 S to be aimed directly into the lumen of the renal artery irrespective of the angle that the renal artery typically makes with the aorta  80 . This is certainly true for all angles “a” of the axis of a renal artery relative to the axis of the aorta (as shown in  FIGS. 8 and 9 ) as normally found in human subjects. Particularly, any angle “a” between 90 degrees and 30 degrees downward could be readily accessed because of the shapes of the curved distal section  11 A and the straight distal section  11 S of the guiding catheter tube  11 . The reason why this is the case is because, as the cardiologist pulls the guiding catheter tube  11  in a downward direction, the distal end  19 E of the tube  11  will snap into and through the ostium of the renal artery into which it is aimed by means of the orientation of the side arm tube  14  at the proximal end of the guiding catheter  12 . This is true because the straight section  19 S will engage the point “p” (which is the apex of the angle “a”) as the guiding catheter tube  11  is pulled downward through the aorta  80 . The cardiologist can then adjust the position of the proximal end of the guiding catheter  12  so that the straight section  19 S is aimed essentially straight into the right renal artery  83  as shown in  FIG. 9 . It is obvious that this technique can also be used to access either the right or the left renal artery. 
     The orientation of the side arm tube  14  that remains outside the patient&#39;s body will indicate to the cardiologist the correct angular orientation (i.e., the azimuth) of the curved distal section  11 A and the straight section  19 S at the distal portion of the guiding catheter tube  11 . This is achievable because when the side arm tube  14  lies horizontally relative to the table on which the patient has been placed on his or her back, then the straight distal section  19 S of the tube  11  will have the correct azimuth angle around the interior lumen of the aorta  80  in order to enter the correct renal artery. Thus when the side arm tube  14  would lie in a direction to the right and parallel to the operating table, then the distal end  19 E of the tube  11  would enter the left renal artery  82 . Likewise, if the side arm tube  14  is lying to the left and is parallel to the operating table, then the azimuth angle of the distal end  19 E of the guiding catheter tube  11  will be correct for entering the right renal artery  83  as shown in  FIG. 9 . 
     This invention envisions that the Tuohy-Borst gland (such as glands  24  or  70 ) could be fabricated from a soft elastomer such as a low durometer silicone rubber. Furthermore, powdered Teflon or powdered graphite could be incorporated into the soft elastomer to improve its lubricity. 
     Thus the objectives of using a guiding catheter without passing it through an introducer sheath and the elimination of the need for a separate Tuohy-Borst “Y” adaptor and a separately attached three-way stopcock have been shown. Furthermore, the objective of inserting a guiding catheter and dilator over a guide wire without the free release of blood through the guiding catheter&#39;s proximal end can be accomplished by compressing the gland  24  around the guiding catheter tube  11  as the guiding catheter system  10  is advanced through the arterial system. 
     Although the discussion herein has been principally concerned with renal guiding catheter systems, the present invention is well suited for the placement of guiding catheters into the ostium of other arteries such as the carotid and coronary arteries as well as coronary artery bypass grafts. 
     Various other modifications, adaptations, and alternative designs are, of course, possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims, the invention may be practiced otherwise then as specifically described herein.

Technology Classification (CPC): 0