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 method of forming a device adapted for use with a standard guide catheter having a continuous lumen extending for a predefined length, the method comprising:
 providing a flexible tip segment having a lumen therethrough;   providing a reinforced segment having a lumen therethrough, including one or more metallic elements covered with a polymer, and extending from a proximal end portion to a distal end portion;   providing a substantially rigid segment extending from a proximal end portion to a distal end portion, wherein the substantially rigid segment is more rigid along a longitudinal axis than the flexible tip segment;   defining a side opening portion, including forming, in a proximal to distal direction, an arcuate cross-sectional shape and a hemicylindrical cross-sectional shape;   eccentrically positioning the distal end portion of the substantially rigid segment relative to a longitudinal axis of the proximal end portion of the reinforced segment; and   coaxially aligning the distal end portion of the reinforced segment and a proximal end portion of the flexible tip segment,   wherein providing the substantially rigid segment, the reinforced segment, and the flexible tip segment includes forming a device length that is longer than the predefined length of the continuous lumen of the guide catheter such that when a distal end portion of the flexible tip segment is extended distally of a distal end of the guide catheter, the proximal end portion of the substantially rigid segment extends proximally of a proximal end of the guide catheter.    
     
     
       26. The method of claim 25, further comprising extending the side opening portion for a distance along a longitudinal axis of the device such that the side opening portion is accessible from a longitudinal side, defined transverse to the longitudinal axis, along the distance.  
     
     
       27. The method of claim 25, wherein providing the substantially rigid segment includes providing one or more relief openings at its distal end portion.  
     
     
       28. The method of claim 27, wherein the one or more relief openings include a first relief opening and a second relief opening, the openings spaced apart from one another.  
     
     
       29. The method of claim 25, wherein providing the substantially rigid segment includes forming or obtaining a hypotube or a metal rail structure.  
     
     
       30. The method of claim 25, wherein providing the substantially rigid segment and the reinforced segment includes, starting at the distal end portion of the reinforced segment and moving proximally toward the proximal end portion of the substantially rigid segment, forming or obtaining at least a first device portion having a first flexural modulus and a second device portion having a second flexural modulus, the second flexural modulus greater than the first flexural modulus.  
     
     
       31. The method of claim 25, wherein providing the reinforced segment includes covering one or more braided or coiled metallic elements with the polymer.  
     
     
       32. The method of claim 31, wherein a length of the one or more braided or coiled metallic elements is in a range of 20 centimeters to 30 centimeters.  
     
     
       33. The method of claim 25, wherein providing the reinforced segment includes forming or obtaining a reinforced segment including a lumen having a uniform inner diameter that is about one French smaller than an inner diameter of the continuous lumen of the guide catheter.  
     
     
       34. The method of claim 33, wherein the lumen of the reinforced segment is greater than or equal to 0.056 inches and the continuous lumen of the guide catheter is greater than or equal to 0.070 inches.  
     
     
       35. The method of claim 25, wherein providing one or both of the reinforced segment and the flexible tip segment includes lining the lumens thereof with polytetrafluoroethylene.  
     
     
       36. The method of claim 25, wherein providing the flexible tip segment includes providing an atraumatic bumper formed of a polymer or an elastomeric material.  
     
     
       37. The method of claim 36, wherein providing the flexible tip segment includes covering a marker band with the polymer or the elastomeric material.  
     
     
       38. A method of forming a device adapted for use with a standard guide catheter having a continuous lumen extending for a predefined length, the method comprising:
 providing a flexible tip segment having a lumen therethrough;   providing a reinforced segment including one or more metallic elements covered with a polymer and having a lumen for coaxial alignment with the lumen of the flexible tip segment;   providing a substantially rigid segment extending from a proximal end portion to a distal end portion, wherein the substantially rigid segment is more rigid along a longitudinal axis than the flexible tip segment;   defining a side opening portion, including forming, in a proximal to distal direction, an arcuate cross-sectional shape and a hemicylindrical cross-sectional shape, the side opening portion extending for a distance along a longitudinal axis of the device such that the side opening is accessible from a longitudinal side, defined transverse to the longitudinal axis, to receive a balloon catheter and stent; and   arranging, in a proximal to distal direction, the substantially rigid segment, the side opening portion, the reinforced segment, and the flexible tip segment such that when the flexible tip segment is extended distally of a distal end of the guide catheter, the proximal end portion of the substantially rigid segment extends proximally of a proximal end of the guide catheter and the side opening portion is positioned within the continuous lumen of the guide catheter.    
     
     
       39. The method of claim 38, wherein providing the substantially rigid segment, defining the side opening, and providing the reinforced segment includes, starting at a distal end portion of the reinforced segment and moving proximally toward the proximal end portion of the substantially rigid segment, forming or obtaining at least a first device portion having a first flexural modulus, a second device portion having a second flexural modulus greater than the first flexural modulus, and a third device portion having a third flexural modulus greater than the second flexural modulus.  
     
     
       40. The method of claim 38, wherein defining the side opening portion includes providing an angled entrance into the lumen of the reinforced segment.  
     
     
       41. The method of claim 38, wherein defining the side opening includes forming an arcuate cross-sectional shape having a length of about 15 centimeters.  
     
     
       42. The method of claim 25, further comprising defining the side opening portion in the substantially rigid segment.  
     
     
       43. The method of claim 38, wherein defining the side opening portion includes forming a concave track.  
     
     
       44. The method of claim 38, wherein defining the side opening portion includes forming a first inclined sidewall, forming a second inclined sidewall, and separating the first inclined sidewall and the second inclined sidewall by a non-inclined region.  
     
     
       45. The method of claim 38, wherein providing the substantially rigid segment, defining the side opening portion, providing the reinforced segment, and providing the flexible tip segment includes forming a device cross-sectional size and shape configured to be passed, at least in part, into the continuous lumen of the guide catheter.