Catheter shaft with an oblong transverse cross-section

Abstract

A balloon dilatation catheter having a catheter shaft with an oblong transverse cross-section with one transverse dimension in a first direction being significantly larger than a second transverse dimension in a direction perpendicular to the first direction. The first dimension is about 1.1 to about 3 times greater, preferably about 1.2 to about 2.5 times greater than the second dimension. In one embodiment, a length of the distal shaft section has inner and outer tubular members where about 30% to not more than about 90% of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member. In another embodiment the flexible distal shaft section is an extruded section having an oval or elliptical transverse cross-section. Preferably a pseudoelastic hypotube of NiTi alloy defines at least part of the inflation lumen within the catheter shaft. In another embodiment of the invention the proximal shaft of the catheter has an inner and outer tubular member.

What is claimed is:  
     
         1 . An elongated dilatation catheter for performing an angioplasty procedure, comprising: 
 a) an elongated catheter shaft having proximal and distal ends, a guidewire receiving inner lumen extending therein to a distal guidewire port in the distal end of the catheter shaft and a inflation lumen extending therein to a inflation port-spaced proximally of the distal end of the catheter shaft;    b) an inflatable dilatation member mounted proximal to the distal end of the catheter shaft for performing an angioplasty procedure which has an interior in fluid communication with inflation lumen through the inflation port; and    c) a flexible catheter shaft section which is proximal to the inflatable dilatation member, which has a length of at least about 4 cm and which has an oblong transverse shape with a first transverse dimension in a first direction substantially greater than a second transverse dimension in a second direction perpendicular to the first direction.    
     
     
         2 . The dilatation catheter of    claim 1    wherein the first transverse dimension is at least 1.1 but not more than 3 times greater than the second transverse dimension.  
     
     
         3 . The dilatation catheter of    claim 1    wherein the first transverse dimension is at least about 1.2 to about 2.5 times greater than the second dimension.  
     
     
         4 . The dilatation catheter of    claim 1    wherein the first transverse dimension is at least 0.003 inch greater than the second transverse dimension.  
     
     
         5 . The dilatation catheter of    claim 1    wherein the first transverse dimension is at least 0.05 inch greater than the second transverse dimension.  
     
     
         6 . The dilatation catheter of    claim 1    wherein the catheter shaft proximal to the inflatable dilatation member has an elliptical or oviform transverse cross-sectional shape.  
     
     
         7 . The dilatation catheter of    claim 1    wherein the catheter shaft section having an oblong transverse shape is not more than about 40 cm in length.  
     
     
         8 . The dilatation catheter of    claim 1    wherein the proximal catheter shaft section has an oblong transverse cross-sectional shape.  
     
     
         9 . The dilatation catheter of    claim 1    wherein a proximal guidewire port is spaced a short distance proximally from the inflatable dilatation member and a substantial distance from the proximal end of the catheter and is in communication with the guidewire receiving inner lumen.  
     
     
         10 . The dilatation catheter of    claim 9    wherein at least one perfusion port extends through the flexible distal shaft section proximal to the inflatable dilatation member and distal to the proximal guidewire port and is in fluid communication with the guidewire receiving inner lumen.  
     
     
         11 . The dilatation catheter of    claim 1    wherein at least one perfusion port is provided in the flexible distal shaft section distal to the inflatable dilatation member which is in fluid communication with the guidewire receiving inner lumen.  
     
     
         12 . The dilatation catheter of    claim 1    wherein the catheter has a proximal section formed at least in part of metal hypotubing having an inner lumen in fluid communication with the inflation lumen in the flexible distal section of the catheter shaft.  
     
     
         13 . The dilatation catheter of    claim 11    wherein the metal hypotubing is formed of a metallic alloy selected from the group-consisting of stainless steel and NiTi alloys.  
     
     
         14 . The dilatation catheter of    claim 12    wherein the alloy is a NiTi alloy having pseudoelastic characteristics.  
     
     
         15 . The dilatation catheter of    claim 1    wherein the flexible distal catheter shaft section includes 
 an inner tubular member having a passageway therethrough which defines the guidewire receiving inner lumen, and  
 an outer tubular member disposed about the inner tubular member with at least about 30% but not more than about 90% of the inner periphery thereof taking the shape of and being secured to the exterior of the inner tubular member along, a length thereof and with a portion of the inner periphery of the outer tubular member being unsecured to the exterior of the inner tubular member with the inner inflation lumen extending along the length between the inner and outer tubular members.  
 
     
     
         16 . The dilatation catheter of    claim 15    wherein not more than 80% of the inner periphery of the outer tubular member along said length is secured to the exterior of the inner tubular member.  
     
     
         17 . The dilatation catheter of    claim 15    wherein the outer tubular member is secured to inner tubular member in the flexible distal catheter shaft section by a heat bond or an adhesive bond.  
     
     
         18 . The dilatation catheter of    claim 15    wherein the outer tubular member has been heat shrunk onto the inner tubular member.  
     
     
         19 . The dilatation catheter of    claim 15    wherein a proximal guidewire port is provided through a wall of the flexible distal section which is spaced a short distance proximally from the inflatable dilatation member and a substantial distance from the proximal end of the catheter shaft and which is in fluid communication with the guidewire receiving inner lumen.  
     
     
         20 . The dilatation catheter of    claim 19    wherein at least one perfusion port extends through a wall of the flexible distal shaft section proximal to the inflatable dilatation member and distal to the proximal guidewire port where the outer tubular member takes the shape of and is secured to the inner tubular member and is in fluid communication with the guidewire receiving inner lumen.  
     
     
         21 . The dilatation catheter of    claim 19    wherein a slit extends distally from the proximal guidewire port through a portion of the flexible distal section in communication with the guidewire receiving inner lumen.  
     
     
         22 . The dilatation catheter of    claim 21    wherein a supporting tube is disposed within the inflation lumen to prevent the expansion thereof.  
     
     
         23 . The dilatation catheter of    claim 1    including a hypotube extending within the catheter shaft defining at least a proximal section of the catheter shaft.  
     
     
         24 . The dilatation catheter of    claim 23    wherein the hypotube is formed of a psuedoelastic NiTi alloy having a stable austenite phase at body temperature.  
     
     
         25 . The dilatation catheter of    claim 15    wherein the length of the outer tubular member which takes the shape of and is secured to the inner tubal member is at least about 4 cm but not more than about 40 cm.  
     
     
         26 . An elongated dilatation catheter for performing an angioplasty procedure, comprising: 
 a) an elongated catheter shaft having proximal and distal ends, a guidewire receiving inner lumen extending therein to a distal guidewire port in the distal end of the catheter shaft and a inflation lumen extending therein to a inflation port spaced proximally of the distal end of the catheter shaft;    b) an inflatable dilatation member mounted proximal to the distal end of the catheter shaft for performing an angioplasty procedure which has an interior in fluid communication with inflation lumen through the inflation port; and    c) a high-strength tubular member which extends through the proximal shaft section from an adaptor on the proximal end of the catheter shaft and which defines the inflation lumen extending therein.    
     
     
         27 . The elongated dilation catheter of    claim 26    wherein the hypotube is formed of a pseudoelastic NiTi alloy having a stable austenite phase at body temperature.  
     
     
         28 . The elongated dilatation catheter of    claim 26    wherein the proximal shaft section has on oblong transverse cross-sectional shape.  
     
     
         29 . An elongated intravascular catheter for performing a therapeutic or diagnostic procedure, comprising: 
 a) an elongated catheter shaft having proximal and distal ends, a length of at least 90 cm, a distal guidewire port in the distal end of the catheter shaft, a first inner lumen extending to the distal guidewire port which is configured to slidably receive a guidewire therein and a second inner lumen extending from the proximal end to a location spaced proximally from the distal end; and    b) a flexible catheter shaft section which has a length of at least about 4 cm and which has a first transverse dimension in a first direction substantially larger than a second transverse dimension in a second direction perpendicular to the first direction.    
     
     
         30 . The intravascular catheter of    claim 29    wherein the first transverse dimension is at least 1.1 but not more than 3 times larger than the second transverse dimension.  
     
     
         31 . The intravascular catheter of    claim 29    wherein the first transverse dimension is at least about 1.2 to about 2.5 times larger than the second transverse dimension.  
     
     
         32 . The intravascular catheter of    claim 29    wherein the first transverse dimension is at least 0.003 inch larger than the second transverse dimension.  
     
     
         33 . The intravascular catheter of    claim 29    wherein the first transverse dimension is at least 0.005 inch larger than the second transverse dimension.  
     
     
         34 . The intravascular catheter of    claim 29    wherein the catheter shaft section has an elliptical or oviform transverse cross-sectional shape.  
     
     
         35 . The intravascular catheter of    claim 29    wherein the catheter shaft has a proximal guidewire port spaced a short distance proximally from the distal end of the catheter and a substantial distance from the proximal end of the catheter and is in communication with the first inner lumen.  
     
     
         36 . The intravascular catheter of    claim 35    wherein the proximal guidewire port is spaced about 5 to about 40 cm from the distal end of the shaft.  
     
     
         37 . The intravascular catheter of    claim 35    wherein the proximal guidewire port is spaced about 10 to about 30 cm from the distal end of the shaft.  
     
     
         38 . The intravascular catheter of    claim 29    wherein the catheter has a proximal section formed at least in part of metal hypotubing having an inner lumen in fluid communication with the second inner lumen in the flexible distal section of the catheter shaft.  
     
     
         39 . The intravascular catheter of    claim 38    wherein the metal hypotubing is formed of a metallic alloy selected from the group consisting of stainless steel and NiTi alloys.  
     
     
         40 . The intravascular catheter of    claim 39    wherein the alloy is a NiTi alloy having pseudoelastic characteristics.  
     
     
         41 . The intravascular catheter of    claim 29    wherein the flexible catheter shaft section includes 
 an inner tubular member having a passageway therethrough which defines the guidewire receiving inner lumen, and  
 an outer tubular member disposed about the inner tubular member with at least about 30% but not more than about 90% of the inner periphery thereof taking the shape of and being secured to the exterior of the inner tubular member along a length thereof and with a portion of the inner periphery of the outer tubular member being unsecured to the exterior of the inner tubular member with the second inner lumen extending along the length between the inner and outer tubular members.  
 
     
     
         42 . The intravascular catheter of    claim 39    wherein the outer tubular member is heat shrunk onto the inner tubular member.  
     
     
         43 . The intravascular catheter of    claim 39    wherein a proximal guidewire port is provided through a wall of the flexible distal section which is spaced a short distance proximally from the distal end of the catheter shaft and a substantial distance from the proximal end of the catheter shaft and which is in fluid communication with the guidewire receiving inner lumen.  
     
     
         44 . The intravascular catheter of    claim 43    wherein the proximal guidewire port is spaced not more than about 40 cm from the distal end of the catheter shaft.  
     
     
         45 . The intravascular catheter of    claim 43    wherein the proximal guidewire port is spaced about 10 to about 30 cm from the distal end of the catheter shaft.  
     
     
         46 . The intravascular catheter of    claim 29    wherein a slit extends distally from the proximal guidewire port through a portion of the flexible distal section in communication with the guidewire receiving inner lumen.  
     
     
         47 . A balloon dilatation catheter for performing an angioplasty procedure, comprising: 
 a) an elongated catheter shaft having proximal and distal ends, a guidewire port in the distal end, a guidewire receiving inner lumen extending therein to the distal guidewire port, an inflation port spaced proximally from the distal end and a inflation lumen extending therein to the inflation port;    b) an inflatable dilatation member mounted proximal to the distal end of the catheter shaft which has an interior in fluid communication with the inflation lumen through the inflation port;    c) a proximal catheter shaft section having an inner tubular member which defines the guidewire receiving inner lumen in the proximal shaft section and an outer tubular member disposed about the inner tubular member and defining between the inner and outer tubular members the inflation lumen within the proximal shaft section; and    d) a flexible distal catheter shaft section distal to the proximal catheter shaft section having a length of at least about 4 cm in which a first transverse dimension in a first direction is substantially greater than a second transverse dimension in a second direction perpendicular to the first direction along said length, a first inner lumen forming the guidewire receiving inner lumen within this catheter shaft section and a second inner lumen forming the inflation lumen within this catheter shaft section.    
     
     
         48 . The dilatation catheter of    claim 47    wherein the first transverse dimension is at least 1.1 but not more than 3 times greater than the second transverse dimension.  
     
     
         49 . The dilatation catheter of    claim 47    wherein the first transverse dimension is at least about 1.2 to about 2.5 times greater than the second dimension.  
     
     
         50 . The dilatation catheter of    claim 47    wherein the first dimension is at least 0.003 inch greater than the second dimension.  
     
     
         51 . The dilatation catheter of    claim 47    wherein the first dimension is at least 0.005 inch greater than the second dimension.  
     
     
         52 . The dilatation catheter of    claim 47    wherein the catheter shaft proximal to the inflatable dilatation member has an elliptical or oviform transverse cross-sectional shape.  
     
     
         53 . The dilatation catheter of    claim 47    wherein a proximal guidewire port is spaced a short distance proximally from the inflatable dilatation member and a substantial distance from the proximal end of the catheter and is in communication with the guidewire receiving inner lumen.  
     
     
         54 . The dilatation catheter of    claim 53    wherein the proximal guidewire port is spaced about 5 to about 40 cm from the distal end of the shaft.  
     
     
         55 . The dilatation catheter of    claim 53    wherein the proximal guidewire port is spaced about 10 to about 30 cm from the distal end of the shaft.  
     
     
         56 . The dilatation catheter of    claim 53    wherein at least one perfusion port extends through the flexible distal shaft section proximal to the inflatable dilatation member and distal to the proximal guidewire port and is in fluid communication with the guidewire receiving inner lumen.  
     
     
         57 . The dilatation catheter of    claim 47    wherein at least one perfusion port is provided in the flexible distal shaft section distal to the inflatable dilatation member which is in fluid communication with the guidewire receiving inner lumen.  
     
     
         58 . The dilatation catheter of    claim 47    wherein the catheter has a proximal section formed at least in part of metal hypotubing having an inner lumen in fluid communication with the inflation lumen in the flexible distal section of the catheter shaft.  
     
     
         59 . The dilatation catheter of    claim 58    wherein the metal hypotubing is formed of a metallic alloy selected from the group consisting of stainless steel and NiTi alloys.  
     
     
         60 . The dilatation catheter of    claim 59    wherein the alloy Is a NiTi alloy having superelastic characteristics.