Coaxial guide catheter for interventional cardiology procedures

Abstract

A coaxial guide catheter to be passed through guide catheter having a first lumen, for use with interventional cardiology devices that are insertable into a branch artery that branches off from a main artery. The coaxial guide catheter is extended through the lumen of the guide catheter and beyond the distal end of the guide catheter and inserted into the branch artery. The device assists in resisting axial and shear forces exerted by an interventional cardiology device passed through the second lumen and beyond the flexible distal tip portion that would otherwise tend to dislodge the guide catheter from the branch artery.

The invention claimed is: 
     
       1. A system for use with interventional cardiology devices adapted to be insertable into a branch artery, the system comprising:
 a guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the continuous lumen of the guide catheter; and   a device adapted for use with the guide catheter, including:
 a flexible tip portion defining a tubular structure and having a circular cross-section and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the tubular structure having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable; and 
 a substantially rigid portion proximal of and operably connected to, and more rigid along a longitudinal axis than the flexible tip portion and defining a rail structure without a lumen having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion and having a length that, when combined with the length of the flexible distal tip portion, defines a total length of the device along the longitudinal axis that is longer than the length of the continuous lumen of the guide catheter, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter. 
   
     
     
       2. The system of  claim 1 , wherein the tubular structure includes a distal portion adapted to be extended beyond the distal end of the guide catheter while a proximal portion remains within the lumen of the guide catheter, such that the device assists in resisting axial and shear forces exerted by the interventional cardiology device passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery. 
     
     
       3. The system of  claim 2 , wherein the proximal portion of the tubular structure further comprises structure defining a proximal side opening extending for a distance along the longitudinal axis, and accessible from a longitudinal side defined transverse to the longitudinal axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal portion remains within the lumen of the guide catheter. 
     
     
       4. The system of  claim 3 , wherein the proximal side opening includes structure defining a full circumference portion and structure defining a partially cylindrical portion. 
     
     
       5. The system of  claim 1 , wherein the tubular structure includes a flexible cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible distal tip portion. 
     
     
       6. The system of  claim 5 , wherein the flexible cylindrical reinforced portion is reinforced with metallic elements in a braided or coiled pattern. 
     
     
       7. The system of  claim 2 , wherein the flexible cylindrical distal tip portion further comprises a radiopaque marker proximate a distal tip. 
     
     
       8. The system of  claim 1 , wherein the cross-sectional inner diameter of the coaxial lumen of the tubular structure is not more than one French smaller than the cross-sectional inner diameter of the guide catheter. 
     
     
       9. The system of  claim 1 , wherein the substantially rigid portion includes from distal to proximal direction, a cross-sectional shape having a full circumference portion, a hemi-cylindrical portion and an arcuate portion. 
     
     
       10. The system of  claim 1 , wherein the predefined length of the guide catheter is about 100 cm and the total length of the device is about 125 cm. 
     
     
       11. The system of  claim 1 , further comprising a kit that includes the guide catheter and the device in a common sterile package. 
     
     
       12. A system for use with interventional cardiology devices adapted to be insertable into a branch artery, the system comprising:
 a guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the continuous lumen of the guide catheter having a circular cross-section and a cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the continuous lumen of the guide catheter; and   a device adapted for use with the guide catheter, including:
 an elongate structure having an overall length that is longer than the predefined length of the continuous lumen of the guide catheter, the elongate structure including: 
 a flexible tip portion defining a tubular structure and having a circular cross-section that is smaller than the circular cross-section of the continuous lumen of the guide catheter and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the flexible tip portion having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable; 
 a reinforced portion proximal to the flexible tip portion; and 
 a substantially rigid portion proximal of, connected to, and more rigid along a longitudinal axis than the flexible tip portion and defining a rail structure without a lumen having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter with at least proximal portion of the reinforced portion remaining within the continuous lumen of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter. 
   
     
     
       13. The system of  claim 12 , wherein, when the distal portion of the flexible tip portion is insertable through the continuous lumen of the guide catheter and beyond the distal end of the guide catheter, the device assists in resisting axial and shear forces exerted by an interventional cardiology device passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery. 
     
     
       14. The system of  claim 12 , wherein the substantially rigid portion further includes a partially cylindrical portion defining an opening extending for a distance along a side thereof defined transverse to a longitudinal axis that is adapted to receive an interventional cardiology device passed through continuous lumen of the guide catheter and into the coaxial lumen while the device is inserted into the continuous lumen, the opening extending substantially along at least a portion of a length of the substantially rigid portion. 
     
     
       15. The system of  claim 12 , wherein, after the device is inserted into the continuous lumen of the guide catheter, the device presents an overall effective length of a coaxial lumen through which an interventional cardiology device may be inserted while utilizing only a single hemostatic valve and without any telescoping structure preassembled prior to the device being inserted into the continuous lumen of the guide catheter. 
     
     
       16. The system of  claim 12 , the device further comprising a radiopaque marker proximate the distal portion of the flexible tip portion. 
     
     
       17. The system of  claim 12 , wherein the reinforced portion of the device is reinforced with metallic elements in a braided or coiled pattern. 
     
     
       18. The system of  claim 12 , wherein the cross-sectional inner diameter of the coaxial lumen of the flexible distal portion is not more than one French smaller than the cross-sectional inner diameter of the guide catheter. 
     
     
       19. The system of  claim 12 , wherein the substantially rigid portion includes, from distal to proximal, a cross-sectional shape having a full circumference portion, a hemicylindrical portion and an arcuate portion. 
     
     
       20. The system of  claim 12 , wherein the elongate structure includes, starting at the distal portion of the flexible distal portion, at least a first portion having a first flexural modulus, a second portion having a second flexural modulus greater than the first flexural modulus, and a third portion having a third flexural modulus greater than the second flexural modulus. 
     
     
       21. The system of  claim 20 , in which the first flexural modulus is about 13,000 PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or minus 10,000 PSI, and the third portion flexural modulus is about 49,000 PSI plus or minus 10,000 PSI. 
     
     
       22. The system of  claim 20 , in which the first portion is about 0.1 cm in length, the second portion is about three cm in length, and the third portion is about five cm in length. 
     
     
       23. The system of  claim 12 , wherein the predefined length of the guide catheter is about 100 cm and the total length of the device is about 125 cm. 
     
     
       24. The system of  claim 12 , further comprising a kit that includes the guide catheter and the device in a common sterile package. 
     
     
       25. A method, comprising:
 advancing a distal end of a guide catheter having a lumen through a main blood vessel to an ostium of a coronary artery;   advancing a distal end of a guide extension catheter through, and beyond the distal end of, the guide catheter, including advancing a distal end portion of a tubular structure of the guide extension catheter beyond the distal end of the guide catheter while a segment defining a side opening of the guide extension catheter remains within the guide catheter, the side opening extending for a distance along a longitudinal axis of the guide extension catheter and accessible from a longitudinal side defined transverse to the longitudinal axis, the tubular structure having a cross-sectional inner diameter that is not more than one French size smaller than a cross-sectional inner diameter of the lumen of the guide catheter;   maintaining the distal end portion of the tubular structure of the guide extension catheter in position beyond the distal end of the guide catheter; and   while maintaining the distal end of the guide extension catheter positioned beyond the distal end of the guide catheter, advancing a balloon catheter or stent at least partially through the guide catheter and the guide extension catheter and into the coronary artery, including advancing the balloon catheter or stent through a hemostatic valve associated with a proximal end of the guide catheter, along a substantially rigid segment of the guide extension catheter, through the side opening, and through the tubular structure.    
     
     
       26. The method of claim 25, further comprising injecting one or more fluids into the coronary artery via the proximal end of the guide catheter.  
     
     
       27. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes opening the hemostatic valve and advancing the distal end of the guide extension catheter through the hemostatic valve and into the guide catheter.  
     
     
       28. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes advancing the distal end of the guide extension catheter proximal to a location of a lesion to be treated in the coronary artery.  
     
     
       29. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes manipulating the substantially rigid segment to advance the segment defining the side opening to a position within the lumen of the guide catheter.  
     
     
       30. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes sealing around the substantially rigid segment with the hemostatic valve associated with the proximal end of the guide catheter.  
     
     
       31. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes advancing the substantially rigid segment within the lumen of the guide catheter.  
     
     
       32. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes coaxially aligning the tubular structure of the guide extension catheter with the lumen of the guide catheter.  
     
     
       33. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes positioning the segment defining the side opening within the guide catheter for receiving the balloon catheter or stent.  
     
     
       34. The method of claim 25, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes establishing fluid communication between the tubular structure of the guide extension catheter and the lumen of the guide catheter.  
     
     
       35. The method of claim 25, wherein maintaining the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes resisting dislodging of the distal end of the guide catheter from the ostium of the coronary artery when the balloon catheter or stent is at least partially advanced through the guide catheter, through the guide extension catheter, and into the coronary artery.  
     
     
       36. The method of claim 25, wherein maintaining the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes using the guide extension catheter to resist axial and shear forces exerted by the balloon catheter or stent when the balloon catheter or stent is advanced at least partially through the guide catheter, through the guide extension catheter, and into the coronary artery.  
     
     
       37. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the guide catheter, through the guide extension catheter, and into the coronary artery includes advancing a delivery system including the stent into the coronary artery.  
     
     
       38. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the guide catheter, through the guide extension catheter, and into the coronary artery includes advancing one or more interventional devices through a single seal, which is the hemostatic valve associated with the proximal end of the guide catheter.  
     
     
       39. The method of claim 25, wherein, subsequent to advancing the balloon catheter or stent at least partially through the hemostatic valve, the method further comprises at least partially sealing around a proximal end portion of the balloon catheter or a delivery system including the stent with the hemostatic valve associated with the proximal end of the guide catheter.  
     
     
       40. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the side opening includes accessing the side opening of the guide extension catheter within the lumen of the guide catheter.  
     
     
       41. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent along a concave track of the side opening, the concave track extending for a length of about 20 cm to about 75 cm.  
     
     
       42. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent through a structure having an arcuate cross-sectional shape.  
     
     
       43. A method, comprising:
 advancing a distal end of a guide catheter having a lumen through a main blood vessel to an ostium of a coronary artery;   advancing a distal end of a guide extension catheter through, and beyond the distal end of, the guide catheter while a segment defining a side opening of the guide extension catheter and a proximal end of a tubular structure of the guide extension catheter remain within the guide catheter, the side opening extending for a distance along a longitudinal axis of the guide extension catheter and accessible from a longitudinal side defined transverse to the longitudinal axis, the tubular structure having a cross-sectional inner diameter that is not more than one French size smaller than a cross-sectional inner diameter of the lumen of the guide catheter; and   with the distal end of the guide extension catheter positioned beyond the distal end of the guide catheter, advancing a treatment catheter at least partially through the guide catheter and the guide extension catheter and into the coronary artery, including advancing a distal portion of the treatment catheter through a hemostatic valve associated with a proximal end of the guide catheter, along a substantially rigid segment of the guide extension catheter, through the side opening, and through the tubular structure,
 wherein advancing the treatment catheter at least partially through the side opening includes advancing the treatment catheter through a structure having an arcuate cross-sectional shape extending for a length of 15 cm.  
   
     
     
       44. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent through a structure having a hemicylindrical cross-sectional shape.  
     
     
       45. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent through a side-opening structure having at least two inclined slopes.  
     
     
       46. The method of any one of claims 25 or 40-45, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent through an opening formed by a material or material combination more rigid than the distal end portion of the tubular structure.  
     
     
       47. The method of claim 25, wherein advancing the balloon catheter or stent at least partially through the tubular structure includes advancing the balloon catheter or stent through a reinforcing braid or coil having a length of 20 to 30 cm.  
     
     
       48. The method of claim 25, wherein advancing the balloon catheter or stent though the side opening and through the tubular structure includes advancing the balloon catheter or stent respectively through a first portion of the guide extension catheter having a first flexural modulus and a second portion of the guide extension catheter having a second flexural modulus less than the first flexural modulus.  
     
     
       49. The method of any one of claim 25, 33, 37, 40 or 48, wherein advancing the balloon catheter or stent at least partially through the side opening includes advancing the balloon catheter or stent through a side-opening structure having one or more slits or cuts.  
     
     
       50. The method of claim 49, wherein at least one cut includes two aligned linear cuts separated by a section of uncut structure.  
     
     
       51. A method, comprising:
 advancing a distal end of a guide catheter having a lumen through a main blood vessel to an ostium of a coronary artery;   advancing a distal end of a guide extension catheter through, and beyond the distal end of, the guide catheter, including advancing a distal end portion of a tubular structure of the guide extension catheter beyond the distal end of the guide catheter while a segment defining an arcuate cross-sectional shape of the guide extension catheter remains within the guide catheter, the arcuate cross-sectional shape extending for a length of at least about 15 cm; and   with the distal end of the guide extension catheter positioned beyond the distal end of the guide catheter, advancing a treatment catheter at least partially through the guide catheter and the guide extension catheter and into the coronary artery, including advancing a distal portion of the treatment catheter through a hemostatic valve associated with a proximal end of the guide catheter, along a substantially rigid segment of the guide extension catheter, along the arcuate cross-sectional shape, and through the tubular structure.    
     
     
       52. A method, comprising:
 advancing a distal end of a guide catheter having a lumen through a main blood vessel to an ostium of a coronary artery;   advancing a distal end of a guide extension catheter through the guide catheter, including advancing a distal end portion of a tubular structure of the guide extension catheter beyond the distal end of the guide catheter while a segment defining a side opening of the guide extension catheter remains within the guide catheter, wherein the segment defining the side opening comprises a portion of the guide extension catheter that is more rigid than the distal end portion of the tubular structure;   maintaining the distal end portion of the tubular structure of the guide extension catheter in position beyond the distal end of the guide catheter; and   while maintaining the distal end of the guide extension catheter positioned beyond the distal end of the guide catheter, advancing a balloon catheter or stent at least partially through the guide catheter and the guide extension catheter and into the coronary artery, including advancing the balloon catheter or stent through a hemostatic valve associated with a proximal end of the guide catheter, along a substantially rigid segment of the guide extension catheter, through the side opening, and through the tubular structure.    
     
     
       53. The method of claim 52, wherein advancing the distal end of the guide extension catheter through the guide catheter includes positioning the segment defining the side opening within the guide catheter for receiving the treatment catheter.  
     
     
       54. The method of claim 52, wherein advancing the treatment catheter at least partially through the side opening includes advancing the balloon catheter or the stent along a concave track of the side opening, the concave track extending for a length of about 20 cm to about 75 cm.  
     
     
       55. The method of claim 52, wherein advancing the treatment catheter at least partially through the side opening includes advancing the treatment catheter through a structure having an arcuate cross-sectional shape, the arcuate cross-sectional shape extending for a length of at least about 15 cm.