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; 
 
 wherein the tubular structure includes a flexible cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible cylindrical distal tip portion and wherein the flexible cylindrical distal tip portion is more flexible than the flexible cylindrical reinforced portion. 
 
     
     
       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  1, 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 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; and 
 wherein the flexible tip portion is more flexible than the reinforced portion. 
 
 
     
     
       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:
 means for guiding an interventional device from a location outside of a subject, through a main vessel, to a location near an ostium of a branch vessel; and   means for receiving the interventional device from an intermediate or distal portion of the means for guiding the interventional device to the location near the ostium of the branch vessel and guiding the interventional device deeper into the branch vessel,
 the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel including, in a distal to proximal direction, a tip portion, a reinforced portion, a side opening, and a substantially rigid portion, and having a length such that when the distal end of the tip portion is extended distally of the distal end of the means for guiding the interventional device to the location near the ostium of the branch vessel, a portion of the proximal end of the substantially rigid portion extends proximally of the proximal end of the means for guiding the interventional device to the location near the ostium of the branch vessel, 
 wherein the tip portion, the reinforced portion, the side opening, and the substantially rigid portion are configured to be passed, at least in part, into a lumen of the means for guiding the interventional device to the location near the ostium of the branch vessel, and 
 the side opening and the substantially rigid portion are configured to be more rigid along a length thereof than the tip portion.  
   
     
     
       26. The system of claim 25, wherein the side opening includes at least one inclined slope.  
     
     
       27. The system of claim 26, wherein the side opening includes at least two different inclined slopes.  
     
     
       28. The system of claim 25, wherein a portion of the side opening includes an arcuate cross-sectional shape extending less than 180° of a full circumference.  
     
     
       29. The system of claim 28, wherein the portion of the side opening having the arcuate cross-sectional shape extends 25% to 40% of a full circumference.  
     
     
       30. The system of claim 28, wherein the side opening includes a portion having a hemicylindrical cross-sectional shape between the portion having the arcuate cross-sectional shape and a portion having a full circumference cross-sectional shape.  
     
     
       31. The system of claim 25, wherein the reinforced portion includes one or more braided elements embedded in a polymer.  
     
     
       32. The system of claim 25, wherein a uniform inner diameter of a lumen of the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel is not more than one French smaller than a second inner diameter of the lumen of the means for guiding the interventional device to the location near the ostium of the branch vessel.  
     
     
       33. The system of claim 32, wherein the lumen of the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel is configured to receive a stent and a balloon catheter.  
     
     
       34. The system of claim 25, wherein the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel includes a concave track along a portion of a length thereof.  
     
     
       35. The system of claim 25, wherein the side opening is incorporated with the distal end of the substantially rigid portion.  
     
     
       36. The system of claim 25, wherein the side opening is incorporated with the proximal end of the reinforced portion.  
     
     
       37. The system of claim 25, wherein the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel includes, starting at the distal end of the tip 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.  
     
     
       38. The system of claim 37, wherein the first flexural modulus is about 13,000 PSI plus or minus 5,000 PSI, the second flexural modulus is about 29,000 PSI plus or minus 10,000 PSI, and the third flexural modulus is about 49,000 PSI plus or minus 10,000 PSI.  
     
     
       39. The system of claim 25, wherein a distal portion of the means for receiving the interventional device and guiding the interventional device deeper into the branch vessel is configured to anchor within the ostium of the branch vessel and resist axial and shear forces exerted by the received interventional device that would otherwise tend to dislodge the distal portion.  
     
     
       40. The system of any one of claim 25-29, 32, 35 or 37-33, wherein a structure forming the side opening includes one or more cuts.  
     
     
       41. The system of claim 40, wherein at least one cut includes two radial cuts along a single line and separated by a section of uncut structure.  
     
     
       42. The system of claim 40, wherein a first cut is spaced approximately 0.010 inches apart from a second cut.