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 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 distill 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 hemicylindrical 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 rail than the flexible tip portion and defining a 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 system, comprising:
 a guide catheter configured to be advanceable through a main blood vessel to a position adjacent an ostium of a coronary artery, the guide catheter having a lumen extending from a hemostatic valve at a proximal end of the guide catheter to a distal end of the guide catheter that is adapted to be positioned adjacent the ostium of the coronary artery; and   a guide extension catheter configured to be partially advanceable through the guide catheter and into the coronary artery, the guide extension catheter having a length such that a distal end of the guide extension catheter is extendable through the lumen and beyond the distal end of the guide catheter, and a proximal end of the guide extension catheter is extendable through the hemostatic valve at the proximal end of the guide catheter,   the guide extension catheter including, in a proximal to distal direction, a substantially rigid segment, a segment defining a side opening, and a tubular structure defining a lumen coaxial and in fluid communication with the lumen of the guide catheter, the lumen of the tubular structure having a length that is shorter than the length of the lumen of the guide catheter and having a uniform cross-sectional inner diameter that is not more than one French size smaller than the cross-sectional inner diameter of the lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the segment defining the side opening and accessible from a longitudinal side defined transverse to the longitudinal axis, and the side opening and the lumen of the tubular structure configured to receive one or more stents or balloon catheters when the segment defining the side opening and a proximal end portion of the tubular structure are positioned within the lumen of the guide catheter and the distal end of the guide extension catheter extends beyond the distal end of the guide catheter;   wherein a material forming the segment defining the side opening is more rigid than the tubular structure.   
     
     
       26. The system of claim 25, wherein the segment defining the side opening includes a portion having an arcuate cross-sectional shape. 
     
     
       27. The system of claim 25, wherein the segment defining the side opening includes a portion having a hemicylindrical cross-sectional shape. 
     
     
       28. The system of claim 25, wherein the segment defining the side opening includes a portion having a full circumference cross-sectional shape. 
     
     
       29. The system of claim 28, wherein the cross-section of the guide extension catheter at the portion of the segment defining the side opening having the full circumference cross-sectional shape includes a single lumen. 
     
     
       30. The system of claim 25, wherein the segment defining the side opening defines a concave track configured to guide the one or more stents or balloon catheters along a length of the concave track. 
     
     
       31. The system of claim 25, wherein the segment defining the side opening includes at least one inclined slope. 
     
     
       32. The system of claim 25, wherein the segment defining the side opening includes at least two inclined slopes. 
     
     
       33. The system of claim 25, wherein the side opening is formed by a cutout portion of a cylindrical tubular structure. 
     
     
       34. The system of claim 25, wherein the segment defining the side opening and the tubular structure comprise a reinforced portion of the guide extension catheter. 
     
     
       35. The system of claim 25, wherein the distal end of the guide extension catheter includes a tip portion. 
     
     
       36. The system of claim 35, wherein a flexural modulus of the tubular structure is greater than a flexural modulus of the tip portion. 
     
     
       37. The system of claim 25, wherein the uniform cross-sectional inner diameter of the lumen of the tubular structure is greater than a largest outer dimension of the substantially rigid segment. 
     
     
       38. The system of claim 25, wherein the substantially rigid segment is eccentrically positioned relative to a cross-section of the tubular structure. 
     
     
       39. The system of claim 38, further comprising a stent releasably joined to the distal end of the elongate balloon catheter. 
     
     
       40. The system of claim 25, further comprising an elongate balloon catheter partially insertable within the guide catheter alongside the substantially rigid segment, through the side opening, and through the lumen of the tubular structure. 
     
     
       41. The system of claim 25, wherein a cross-section of the substantially rigid segment is sufficiently sized and configured to permit the tubular structure of the guide extension catheter to be partially advanced through the guide catheter and into the coronary artery without blocking use of the guide catheter. 
     
     
       42. The system of claim 25, wherein the substantially rigid segment and the tubular structure are operably coupled at or adjacent to the segment defining the side opening. 
     
     
       43. The system of claim 25, further comprising means for releasably joining the proximal end of the guide catheter and the proximal end of the guide extension catheter. 
     
     
       44. The system of claim 25, wherein a flexural modulus of the segment defining the side opening is greater than a flexural modulus of the tubular structure. 
     
     
       45. The system of claim 25, wherein the guide extension catheter is configured such that the proximal end of the tubular structure cannot be advanced to or past the distal end of the guide catheter. 
     
     
       46. The system of claim 25, wherein the segment defining the side opening includes one or more cuts and wherein a first cut is spaced approximately 0.010 inches apart from a second cut. 
     
     
       47. The system of claim 25, wherein a distal portion of the guide extension catheter is configured to anchor within the ostium of the coronary artery and resist axial and shear forces exerted by the one or more received stents or balloon catheters that would otherwise tend to dislodge the distal portion. 
     
     
       48. A system, comprising:
 a guide catheter configured to be advanceable through a main blood vessel to a position adjacent an ostium of a coronary artery, the guide catheter having a lumen extending from a hemostatic valve at a proximal end of the guide catheter to a distal end of the guide catheter that is adapted to be positioned adjacent the ostium of the coronary artery; and   a guide extension catheter configured to be partially advanceable through the guide catheter and into the coronary artery, the guide extension catheter having a length such that a distal end of the guide extension catheter is extendable through the lumen and beyond the distal end of the guide catheter, and a proximal end of the guide extension catheter is extendable through the hemostatic valve at the proximal end of the guide catheter,   the guide extension catheter including, in a proximal to distal direction, a substantially rigid segment, a segment defining a side opening, and a tubular structure defining a lumen coaxial and in fluid communication with the lumen of the guide catheter, the lumen of the tubular structure having a length that is shorter than the length of the lumen of the guide catheter and having a uniform cross-sectional inner diameter that is not more than one French size smaller than the cross-sectional inner diameter of the lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the segment defining the side opening and accessible from a longitudinal side defined transverse to the longitudinal axis, and the side opening and the lumen of the tubular structure configured to receive one or more stents or balloon catheters when the segment defining the side opening and a proximal end portion of the tubular structure are positioned within the lumen of the guide catheter and the distal end of the guide extension catheter extends beyond the distal end of the guide catheter;   wherein the segment defining the side opening comprises a portion of the guide extension catheter that is more rigid than a distal end portion of the tubular structure.   
     
     
       49. The system of any one of claims 25, 31, 32, 48, 38, 40, 41 or 43, wherein the segment defining the side opening includes one or more cuts. 
     
     
       50. The system of claim 49, wherein at least one cut includes two circumferential cuts along a single line and separated by a section of uncut structure. 
     
     
       51. A system, comprising:
 a guide catheter configured to be advanceable through a main blood vessel to a position adjacent an ostium of a coronary artery, the guide catheter having a lumen extending from a hemostatic valve at a proximal end of the guide catheter to a distal end of the guide catheter that is adapted to be positioned adjacent the ostium of the coronary artery; and   a guide extension catheter configured to be partially advanceable through the guide catheter and into the coronary artery, the guide extension catheter having a length such that a distal end of the guide extension catheter is extendable through the lumen and beyond the distal end of the guide catheter, and a proximal end of the guide extension catheter is extendable through the hemostatic valve at the proximal end of the guide catheter,   the guide extension catheter including, in a proximal to distal direction, a substantially rigid segment, a segment defining a side opening, and a tubular structure defining a lumen coaxial and in fluid communication with the lumen of the guide catheter, the lumen of the tubular structure having a length that is shorter than the length of the lumen of the guide catheter and having a uniform cross-sectional inner diameter that is not more than one French size smaller than the cross-sectional inner diameter of the lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the segment defining the side opening and accessible from a longitudinal side defined transverse to the longitudinal axis, and the side opening and the lumen of the tubular structure configured to receive one or more stents or balloon catheters when the segment defining the side opening and a proximal end portion of the tubular structure are positioned within the lumen of the guide catheter and the distal end of the guide extension catheter extends beyond the distal end of the guide catheter;   wherein the tip portion includes an atraumatic bumper formed from a flexible material and having a lumen continuous with the lumen of the tubular structure; and   wherein the tubular structure includes a reinforcing braid or coil, and wherein the tip portion includes a marker band positioned distal to the distal end of the reinforcing braid or coil.   
     
     
       52. The system of claim 51, wherein a longitudinal length of the reinforcing braid or coil is between 20 to 30 cm. 
     
     
       53. A system, comprising:
 a guide catheter configured to be advanceable through a main blood vessel to a position adjacent an ostium of a coronary artery, the guide catheter having a lumen extending from a hemostatic valve at a proximal end of the guide catheter to a distal end of the guide catheter that is adapted to be positioned adjacent the ostium of the coronary artery; and   a guide extension catheter configured to be partially advanceable through the guide catheter and into the coronary artery, the guide extension catheter having a length such that a distal end of the guide extension catheter is extendable through the lumen and beyond the distal end of the guide catheter, and a proximal end of the guide extension catheter is extendable through the hemostatic valve at the proximal end of the guide catheter,   the guide extension catheter including, in a proximal to distal direction, a substantially rigid segment, a segment defining a side opening, and a tubular structure defining a lumen coaxial and in fluid communication with the lumen of the guide catheter, the lumen of the tubular structure having a length that is shorter than the length of the lumen of the guide catheter and having a uniform cross-sectional inner diameter that is not more than one French size smaller than the cross-sectional inner diameter of the lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the segment defining the side opening and accessible from a longitudinal side defined transverse to the longitudinal axis, and the side opening and the lumen of the tubular structure configured to receive one or more stents or balloon catheters when the segment defining the side opening and a proximal end portion of the tubular structure are positioned within the lumen of the guide catheter and the distal end of the guide extension catheter extends beyond the distal end of the guide catheter;   wherein a material forming the segment defining the side opening is more rigid than the tubular structure;   wherein a flexural modulus of the substantially rigid segment is greater than a flexural modulus of the tubular structure.