Retrograde coronary sinus catheter having a ribbed balloon

Claim 2

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon.

Claim 3

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

Claim 4

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

Claim 5

A coronary sinus catheter according to claim 2 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

Claim 6

A coronary sinus catheter according to claim 3 wherein the plurality of segemented ribs or lands comprises six segmented ribs or lands, each segmented rib or land having the same number of raised rib portions and non-raised portions as the other ribs or lands.

Claim 7

A coronary sinus catheter according to claim 2 wherein the non-raised portions preferentially stretch in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated.

Claim 8

A coronary sinus catheter according to claim 2 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

Claim 9

A coronary sinus catheter according to claim 6 wherein: the balloon comprises a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube, the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon; the segmented ribs or lands being integrally molded with the balloon of silicone material constituting the elastomeric material; and the balloon having a wall thickness when not inflated of approximately 0.33-0.48 millimeters, and the pressure sensor tube has a wall thickness of approximately 0.76-1.01 millimeters and a durometer in the range of 35-50 on the Shore A scale.

Claim 10

A coronary sinus catheter according to claim 2 wherein the pressure sensor tube has a durometer in the range of 35-50 on the Shore A scale, and a wall thickness in the range of 0.6-1.3 millimeters.

Claim 11

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; each segmented rib or land comprising a plurality of solid raised rib portions separated by non-raised portions and extending annularly around the periphery of the balloon in alternating fashion with the non-raised portions, the raised rib portions of adjacent ribs or lands being generally aligned along the longitudinal direction of the catheter.

Claim 12

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; each segmented rib or land comprising a plurality of solid raised rib portions separated by non-raised portions and extending annularly around the periphery of the balloon in alternating fashion with the non-raised portions, the raised rib portions of adjacent ribs or lands being generally aligned along the longitudinal direction of the catheter.

Claim 13

A coronary sinus catheter according to claim 9 wherein the non-raised portions preferentially stretch in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated.

Claim 14

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heat, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure senor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 15

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heat, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure senor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 16

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land, the non-raised portions preferentially stretch in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 17

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land, the non-raised portions preferentially stretch in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 18

A coronary sinus catheter assembly according to claim 12 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands, each segmented rib or land having the same number of raised rib portions and non-raised portions as the other ribs or lands.

Claim 19

A coronary sinus catheter assembly according to claim 12 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

Claim 20

A coronary sinus catheter assembly according to claim 14 wherein: the balloon comprises a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube, the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon; the segmented ribs or lands being integrally molded with the balloon of silicone material constituting the elastomeric material; and the pressure sensor tube having a durometer in the range of 35-50 on the Shore A scale, and a wall thickness in the range of 0.6-1.3 millimeters.

Claim 21

A coronary sinus catheter assembly according to claim 15 wherein the balloon has a wall thickness when not inflated of approximately 0.33-0.48 millimeters, and the pressure sensor tube has a wall thickness of approximately 0.76-1.01 millimeters.

Claim 22

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material, each segmented rib or land comprising a plurality of solid raised rib portions separated by non-raised portions and extending annularly around the periphery of the balloon in alternating fashion with the non-raised portions, the raised rib portions of adjacent ribs or lands being generally aligned along the longitudinal direction of the catheter, the non-raise portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 23

A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter assembly comprising: a catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and including infusion, pressure-sensing and inflation lumens extending longitudinally through the catheter tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and at least one pressure-sensing lumen outlet generally adjacent the distal end of the catheter tube; an inflatable balloon on the catheter tube, generally adjacent the distal end of the catheter tube proximally of the infusion lumen and pressure-sensing lumen outlets, for securing the distal end of the catheter in the coronary sinus, one end of the inflation lumen being in fluid communication with the interior of the balloon for inflating the balloon, and the balloon being molded of elastomeric material having a durometer in the range of 20 to 35 on the Shore A scale, and having a wall thickness in the range of 0.3-0.5 millimeters when not inflated, the balloon further having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material, each segmented rib or land comprising a plurality of solid raised rib portions separated by non-raised portions and extending annularly around the periphery of the balloon in alternating fashion with the non-raised portions, the raised rib portions of adjacent ribs or lands being generally aligned along the longitudinal direction of the catheter, the non-raise portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated, thereby reducing stretching and distortion of the raised rib portions as the balloon is inflated; pressure sensor tube means for providing an observable indication of pressure in the balloon to indicate the status of the balloon, the pressure sensor tube means comprising a pressure sensor tube, one end of which is in fluid communication with the end of the inflation lumen opposite the inflation balloon, the pressure sensor tube being formed of elastomeric material having a durometer greater than 35 on the Shore A scale, and having a wall thickness greater than 0.6 millimeters, the pressure sensor tube having an internal volume that is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter; and a connection device in fluid communication with the end of the pressure sensor tube opposite the inflation lumen for connecting a pressurizing means to the catheter to inflate and/or deflate the inflatable balloon; and a stylet removably received in the infusion lumen of the catheter.

Claim 24

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable from a un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus; the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated to its inflated diameter, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land; the plurality of segmented ribs or lands comprising three to seven segmented ribs or lands; each segmented rib or land having the same number of raised rib portions and non-raised portions as the other ribs or lands; and the raised rib portions having a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

Claim 25

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable from a un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus; the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated to its inflated diameter, the balloon including the ribs or lands being integrally molded of generally uniform elastomeric material; the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land; the plurality of segmented ribs or lands comprising three to seven segmented ribs or lands; each segmented rib or land having the same number of raised rib portions and non-raised portions as the other ribs or lands; and the raised rib portions having a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

Claim 26

A coronary sinus catheter according to claim 18 wherein the segmented ribs or lands are integrally molded with the balloon of silicone material constituting the elastomeric material.

Claim 27

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable from a un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus; the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raise rib portions as the balloon is inflated to its inflated diameter, the segmented ribs or lands are integrally molded with the balloon of silicone material constituting the elastomeric material, the balloon having a wall thickness when not inflated of approximately 0.33-0.48 millimeters.

Claim 28

A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient's heart, the catheter comprising: a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable from a un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus; the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raise rib portions as the balloon is inflated to its inflated diameter, the segmented ribs or lands are integrally molded with the balloon of silicone material constituting the elastomeric material, the balloon having a wall thickness when not inflated of approximately 0.33-0.48 millimeters.