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:
 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 rain 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 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 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: 
 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 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 guide extension catheter for use with a guide catheter, comprising:
 a substantially rigid segment;   a tubular structure defining a lumen and positioned distal to the substantially rigid segment; and   a segment defining a partially cylindrical opening positioned between a distal end of the substantially rigid segment and a proximal end of the tubular structure, the segment defining the partially cylindrical opening having an angled proximal end, formed from a material more rigid than a material or material combination forming the tubular structure, and configured to receive one or more interventional cardiology devices therethrough when positioned within the guide catheter,   wherein a cross-section of the guide extension catheter at the proximal end of the tubular structure defines a single lumen.    
     
     
       26. The guide extension catheter of claim 25, wherein the angled proximal end of the partially cylindrical opening originates adjacent the distal end of the substantially rigid segment and extends distally toward the tubular structure. 
     
     
       27. The guide extension catheter of claim 25, wherein the segment defining the partially cylindrical opening includes a portion having an arcuate cross-sectional shape.  
     
     
       28. The guide extension catheter of claim 27, wherein the portion having the arcuate cross-sectional shape extends for a length of 15 cm.  
     
     
       29. The guide extension catheter of claim 27, wherein the arcuate cross-sectional shape radially extends 25% to 40% of a cross-sectional circumference of a tube.  
     
     
       30. The guide extension catheter of claim 25, wherein the guide catheter includes a lumen having a cross-sectional inner diameter of six French, seven French or eight French and wherein a cross-sectional inner diameter of the lumen of the tubular structure is not more than one French size smaller than a cross-sectional inner diameter of a lumen of the guide catheter.  
     
     
       31. The guide extension catheter of claim 30, wherein the cross-sectional inner diameter of the lumen of the tubular structure is uniform in size from a proximal end to a distal end of the tubular structure.  
     
     
       32. The guide extension catheter of claim 30, wherein the lumen of the tubular structure is configured to receive a stent and a balloon catheter.  
     
     
       33. The guide extension catheter of claim 25, wherein the segment defining the partially cylindrical opening includes a portion having a hemicylindrical cross-sectional shape. 
     
     
       34. The guide extension catheter of claim 33, wherein the portion having the hemicylindrical cross-sectional shape extends for a length of 20 cm to 75 cm.  
     
     
       35. The guide extension catheter of claim 33, wherein the hemicylindrical cross-sectional shape radially extends 40% to 70% of a cross-sectional circumference of a tube.  
     
     
       36. The guide extension catheter of claim 25, wherein the segment defining the angled proximal end of the partially cylindrical opening includes at least one inclined region that tapers into a non-inclined region.  
     
     
       37. The guide extension catheter of claim 25, wherein the segment defining the partially cylindrical opening defines a concave track that is continuous with the lumen of the tubular structure.  
     
     
       38. The guide extension catheter of claim 25, wherein the substantially rigid segment is formed from a hypotube.  
     
     
       39. The guide extension catheter of claim 25, wherein the substantially rigid segment is formed from a section of stainless steel.  
     
     
       40. The guide extension catheter of claim 25, wherein the substantially rigid segment is formed from a section of Nitinol tubing.  
     
     
       41. The guide extension catheter of claim 25, wherein the substantially rigid segment is eccentrically positioned relative to a cross-section of the tubular structure.  
     
     
       42. The guide extension catheter of claim 25, wherein a cross-section of the substantially rigid segment is sufficiently sized and configured to permit the tubular structure to be advanced within and partially through the guide catheter while permitting at least partial delivery of the one or more received interventional cardiology devices alongside the substantially rigid segment, through the angled proximal end of the partially cylindrical opening, and through the lumen of the tubular structure.  
     
     
       43. The guide extension catheter of claim 25, wherein the substantially rigid segment has an outer size and the lumen of the tubular structure has an inner size, the inner size of the lumen being greater than the outer size of the substantially rigid segment.  
     
     
       44. The guide extension catheter of claim 25, further comprising a tip portion positioned distal to the distal end of the tubular structure.  
     
     
       45. The guide extension catheter of claim 25, wherein the tubular structure includes a reinforcing braid or coil extending along a portion of a length of the tubular structure and surrounded by one or more polymer materials.  
     
     
       46. The guide extension catheter of claim 45, wherein a length of the reinforcing braid or coil is 20 to 30 cm.  
     
     
       47. The guide extension catheter of claim 25, wherein the substantially rigid segment and the partially cylindrical opening comprise a rigid portion of the guide extension catheter. 
     
     
       48. The guide extension catheter of claim 25, wherein the partially cylindrical opening and the tubular structure comprise a reinforced portion of the guide extension catheter.  
     
     
       49. The guide extension catheter of claim 25, wherein a distal portion of the tubular structure is configured to anchor within an ostium of a coronary vessel and resist axial and shear forces exerted by the received one or more interventional cardiology devices that would otherwise tend to dislodge the distal portion. 
     
     
       50. The guide extension catheter 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. The system of claim 49, wherein a first cut is spaced approximately 0.010 inches apart from a second cut. 
     
     
       52. A guide extension catheter for use with a guide catheter, comprising:
 a substantially rigid segment;   a tubular structure defining a lumen and positioned distal to the substantially rigid segment; and   a segment defining a partially cylindrical opening positioned between a distal end of the substantially rigid segment and a proximal end of the tubular structure, the segment defining the partially cylindrical opening having an angled proximal end, formed from a material having a greater flexural modulus than a flexural modulus of the tubular structure, and configured to receive one or more interventional cardiology devices therethrough when positioned within the guide catheter,   wherein a cross-section of the guide extension catheter at the proximal end of the tubular structure defines a single lumen;   wherein the segment defining the angled proximal end of the partially cylindrical opening includes at least two inclined regions.    
     
     
       53. A guide extension catheter for use with a guide catheter having a lumen with a cross-sectional inner diameter, comprising:
 a substantially rigid segment;   a tubular structure defining a lumen and positioned distal to the substantially rigid segment, the lumen 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; and   a segment defining a partially cylindrical opening positioned between a distal end of the substantially rigid segment and a proximal end of the tubular structure, the segment defining the partially cylindrical opening having an angled proximal end and configured to receive one or more interventional cardiology devices when positioned within the lumen of the guide catheter, a cross-section of the guide extension catheter at the proximal end of the tubular structure defining a single lumen;   wherein the segment defining the angled proximal end of the partially cylindrical opening includes at least two inclined regions.   
     
     
       54. The guide extension catheter of claim 53, wherein the segment defining the partially cylindrical opening is formed from a structure having a greater flexural modulus than a flexural modulus of the tubular structure.  
     
     
       55. The guide extension catheter of claim 53, wherein the segment defining the partially cylindrical opening includes portion having an arcuate cross-sectional shape, a portion having a hemicylindrical cross-sectional shape, and a portion having a full circumference cross-sectional shape.  
     
     
       56. The guide extension catheter of claim 53, 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 advanced partially through the guide catheter and into a coronary artery while preserving space of the cross-sectional inner diameter of the lumen of the guide catheter.  
     
     
       57. The guide extension catheter of any one of claim 25, 28, 30-32, 34, 36, 38, 47, 49 53-54, wherein the segment defining the partially cylindrical opening includes one or more cuts.