Inflatable balloon over catheter with bypass passageway

Abstract

A medical device that delivers therapeutic agent to the tissue within the bodily passageway while simultaneously permitting flow of bodily fluids past the location of treatment. The medical device includes an inflatable balloon and optionally one or more balloon wall openings that are configured to allow fluid in the interior of the inflatable balloon to flow through the inflatable balloon when the inflatable balloon is pressurized by the fluid in the interior of the inflatable balloon. During the inflation of the inflatable balloon at the treatment site, the flow of blood through the blood vessel is maintained across the treatment site by use of one or more bypass passageways in the medical device.

1 - 26 . (canceled) 
     
     
         27 . A medical device comprising a catheter, a first expandable device positioned on said catheter, and a bypass passageway that enables continued blood flow in a blood vessel and about said first expandable device when said first expandable device is expanded in the blood vessel; said bypass passageway includes one or more arrangements selected from the group consisting of a) said bypass passageway is at least partially formed of a fluid passageway that is separate from said catheter, b) said bypass passageway includes a fluid passageway that extends beyond said catheter, c) said bypass passageway includes a proximal end opening and one or more proximal side wall openings that are both positioned proximal to said first expandable device and wherein said proximal end opening and said one or more proximal side openings enable blood flow into an interior of said bypass passageway when said first expandable device is expanded in the blood vessel, d) said bypass passageway includes a distal end opening and one or more distal side wall openings that are both positioned distal to said first expandable device and wherein said distal end opening and said one or more distal side openings enable blood flow to exit from an interior of said bypass passageway when said first expandable device is expanded in the blood vessel, and e) said bypass passageway includes a first electrode or electrically conductive element positioned on said bypass passageway, said first electrode or electrically conductive element is electrically connected via a wire to a power source spaced rearwardly of a proximal end of said first expandable device. 
     
     
         28 . The medical device as defined in  claim 27 , wherein said first expandable device includes one or more devices selected from the group consisting of a) a first inflatable balloon, b) a first expandable stent, c) a first expandable balloon and a first expandable stent mounted on an outer surface of said first inflatable balloon, d) a first inflatable balloon coated with therapeutic drug, e) a first expandable stent coated with therapeutic drug, f) a first inflatable balloon with a plurality of holes, g) a first drug coated stent mounted over an inflatable balloon, h) a first drug coated stent mounted over a drug coated balloon, and i) a stent mounted over a balloon with a plurality of holes. 
     
     
         29 . The medical device as defined in  claim 28 , wherein said first expandable device includes said first expandable balloon; said first inflatable balloon includes one or more balloon wall openings. 
     
     
         30 . The medical device as defined in  claim 27 , wherein said bypass passageway is partially or fully formed by one or more structures selected from the group consisting of a) said catheter, b) a guidewire passageway, and c) a passageway separate from said catheter and said guidewire passageway. 
     
     
         31 . The medical device as defined in  claim 28 , wherein said bypass passageway is partially or fully formed by one or more structures selected from the group consisting of a) said catheter, b) a guidewire passageway, and c) a passageway separate from said catheter and said guidewire passageway. 
     
     
         32 . The medical device as defined in  claim 27 , further including a first electrode or electrically conductive element; said first electrode or electrically conductive element is electrically connected via a wire to a power source spaced rearwardly of a proximal end of said first expandable device; said first electrode or electrically conductive element is located in one or more locations selected from the group consisting of a) inside said first expandable device, b) on an exterior surface of said first expandable device, c) spaced rearwardly of a proximal end of said first expandable device, d) spaced forwardly of a distal end of said first expandable device, e) positioned on said bypass passageway, and f) positioned on said catheter. 
     
     
         33 . The medical device as defined in  claim 31 , further including a first electrode or electrically conductive element; said first electrode or electrically conductive element is electrically connected via a wire to a power source spaced rearwardly of a proximal end of said first expandable device; said first electrode or electrically conductive element is located in one or more locations selected from the group consisting of a) inside said first expandable device, b) on an exterior surface of said first expandable device, c) spaced rearwardly of a proximal end of said first expandable device, d) spaced forwardly of a distal end of said first expandable device, e) positioned on said bypass passageway, and f) positioned on said catheter. 
     
     
         34 . The medical device as defined in  claim 32 , further including a second electrode or electrically conductive element; said second electrode or electrically conductive element is located in one or more locations selected from the group consisting of a) inside said first expandable device, b) on an exterior surface of said first expandable device, c) spaced rearwardly of a proximal end of said first expandable device, d) spaced forwardly of a distal end of said first expandable device, e) spaced outside of said blood vessel, f) spaced outside the body and positioned close to or in contact with the body, g) positioned on said bypass passageway, and h) positioned on said catheter; said second electrode or electrically conductive element is spaced from said first electrode or electrically conductive element. 
     
     
         35 . The medical device as defined in  claim 33 , further including a second electrode or electrically conductive element; said second electrode or electrically conductive element is located in one or more locations selected from the group consisting of a) inside said first expandable device, b) on an exterior surface of said first expandable device, c) spaced rearwardly of a proximal end of said first expandable device, d) spaced forwardly of a distal end of said first expandable device, e) spaced outside of said blood vessel, f) spaced outside the body and positioned close to or in contact with the body, g) positioned on said bypass passageway, and h) positioned on said catheter; said second electrode or electrically conductive element is spaced from said first electrode or electrically conductive element. 
     
     
         36 . The medical device as defined in  claim 27 , wherein said catheter has a passageway having an opening in an interior of said first expandable device; a distal portion of said catheter is connected to a proximal portion of said first expandable device. 
     
     
         37 . The medical device as defined in  claim 27 , wherein said bypass passageway has a proximal end that is spaced rearwardly of a proximal end of said first expandable device; said bypass passageway has a distal end that is spaced forwardly of a distal end of said first expandable device; said proximal end includes said proximal end opening, said distal end includes said distal end opening. 
     
     
         38 . The medical device as defined in  claim 27 , wherein said bypass passageway includes one or more arrangements selected from the group consisting of a) said proximal end opening is located within 20 inches of a proximal end of said first expandable device, b) said one or more proximal side openings are located within 20 inches of a proximal end of said first expandable device, c) said distal end opening is located within 5 inches of a distal end of said first expandable device, and d) said one or more distal side openings are located within 5 inches of a distal end of said first expandable device. 
     
     
         39 . The medical device as defined in  claim 27 , further including one or more luer connectors on said catheter. 
     
     
         40 . The medical device as defined in  claim 27 , further including a first radiopaque marker; said first radiopaque marker is located in one or more locations selected from the group consisting of a) inside said first expandable device, b) on an exterior surface of said first expandable device, c) spaced rearwardly of a proximal end of said first expandable device, d) spaced forwardly of a distal end of said first expandable device, e) positioned on said bypass passageway, and f) positioned on said catheter. 
     
     
         41 . The medical device as defined in  claim 27 , further including a side branch passageway that is at least partially located in said first expandable device; a first end of said side branch passageway fluidly connected to one or more structures selected form the group consisting of a) said catheter, b) a guidewire passageway, and c) a passageway separate from said catheter and said guidewire passageway; a second end of said side branch passageway extending to a wall of said first expandable device or extending outwardly from said wall of said first expandable device. 
     
     
         42 . The medical device as defined in  claim 27 , further including a second first expandable device located forwardly of a distal end of said first expandable device; said first and second expandable devices are in fluid communication with one another; a supply of fluid to said second expandable device is provided by one or more sources selected from the group consisting of a) said catheter which also supplies fluid to said first expandable device, and b) an auxiliary balloon passageway that is fluidly connected between said first and second expandable devices. 
     
     
         43 . The medical device as defined in  claim 42 , further including one or more structures selected from the group consisting of a) an auxiliary electrode or electrically conductive element that is located i) inside said second inflatable balloon, ii) on an exterior surface of said second inflatable balloon, iii) spaced rearwardly of a proximal end of said second inflatable balloon, or iv) spaced forwardly of a distal end of said second inflatable balloon; said auxiliary electrode or electrically conductive element is electrically connected via a wire to a power source spaced rearwardly of a proximal end of said first and second inflatable balloons; b) a radiopaque marker located i) inside said second inflatable balloon, ii) on an exterior surface of said second inflatable balloon, iii) spaced rearwardly of a proximal end of said second inflatable balloon, or iv) spaced forwardly of a distal end of said second inflatable balloon; c) a stent mounted on said exterior surface of said second inflatable balloon; d) a coating of therapeutic agent coated on said exterior surface of said second inflatable balloon; and e) one or more balloon wall openings in said second inflatable balloon. 
     
     
         44 . The medical device as defined in  claim 42 , wherein said auxiliary balloon passageway includes one or more wall openings.