Method and apparatus for pressurized intraluminal drug delivery

Claim 3

A method as in claim 1, wherein the body lumen is a blood vessel.

Claim 4

A method as in claim 1, wherein from 6 to 64 isolated pockets are provided and wherein the isolated pockets each have an area in the range from 10 mm 2 to 60 mm 2 .

Claim 5

A method as in claim 3, wherein the isolated pockets are substantially uniformly distributed over the outer peripheral surface of the balloon.

Claim 6

A method as in claim 1, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 6 atm and wherein the fluid is delivered to said isolated pockets at a delivery pressure in the range from 0.5 psi to 10 psi.

Claim 7

A method as in claim 1, wherein the fluid is delivered to said isolated pockets from delivery lumens and through flow-limiting infusion ports, wherein the delivery lumens and flow-limiting infusion ports are present on a catheter which carries the balloon.

Claim 8

A method as in claim 6, wherein the flow-limiting infusion ports open to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

Claim 9

A method as in claim 1, wherein the providing step comprises disposing a network of fluid infusion tubes between the balloon and the inner wall portion, wherein the fluid infusion tubes are arranged to form said isolated pockets.

Claim 10

A method as in claim 8, wherein the fluid infusion tubes are arranged to form a diamond pattern when the balloon is expanded.

Claim 11

A method as in claim 8, wherein the network of fluid infusion tubes is disposed on an expansible sleeve which is positioned between the balloon and the luminal wall prior to balloon expansion.

Claim 12

A method as in claim 10, wherein the balloon is non-distensible.

Claim 13

A method as in claim 10, wherein the balloon is elastomeric.

Claim 14

A method as in claim 8, wherein the network of fluid infusion tubes is disposed as an integral component of the balloon.

Claim 15

A method as in claim 13, wherein the balloon is non-distensible.

Claim 16

A method as in claim 13, wherein the balloon is elastomeric.

Claim 17

An infusion catheter for intramural drug delivery within a body lumen, said infusion catheter comprising: a catheter body having a proximal end, a distal end, and a fluid delivery lumen therethrough; and a radially expansible segment disposed at the distal end of the catheter body, said radially expansible segment having a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when said segment is expanded against a body lumen wall, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

Claim 18

An infusion catheter for intramural drug delivery within a body lumen, said infusion catheter comprising: a catheter body having a proximal end, a distal end, and a fluid delivery lumen therethrough; and a radially expansible segment disposed at the distal end of the catheter body, said radially expansible segment having a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when said segment is expanded against a body lumen wall, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

Claim 19

An infusion catheter as in claim 16, further comprising a balloon near the distal end of the catheter body, wherein the network of infusion tubes are formed over an outer peripheral surface of the balloon.

Claim 20

An infusion catheter as in claim 17, wherein the balloon is non-distensible and the infusion tubes are integrally formed therewith.

Claim 21

An infusion catheter as in claim 17, wherein the balloon is elastomeric and the infusion tubes are formed from a different material and attached to the balloon.

Claim 22

An infusion catheter as in claim 16, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

Claim 23

An infusion catheter as in claim 16, wherein the radially expansible segment comprises a receptacle which receives and is expanded by a balloon of a balloon catheter deployed therein.

Claim 24

An infusion catheter as in claim 16, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment and wherein the isolated pockets each have an area in the range from 10 mm 2 to 60 mm 2 .

Claim 25

An infusion catheter as in claim 16, wherein the fluid infusion tubes are arranged to form a diamond pattern when the expansible segment is expanded.

Claim 26

An infusion catheter as in claim 16, wherein the catheter body comprises a shaft having the fluid delivery lumen therethrough and wherein the radially expansible segment comprises a sleeve having the fluid infusion tubes formed thereover.

Claim 27

An infusion catheter as in claim 24, further comprising a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

Claim 28

An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising: a catheter body having a proximal and a distal end; a radially expansible sleeve disposed at the distal end of the catheter body, said radially expansible sleeve having a central receptacle, for receiving a balloon or the balloon catheter, and a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

Claim 29

An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising: a catheter body having a proximal and a distal end; a radially expansible sleeve disposed at the distal end of the catheter body, said radially expansible sleeve having a central receptacle, for receiving a balloon or the balloon catheter, and a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

Claim 30

An infusion catheter as in claim 26, wherein the catheter body comprises a shaft having a fluid delivery lumen therethrough.

Claim 31

An infusion catheter as in claim 27, further comprising a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

Claim 32

An infusion catheter as in claim 26, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

Claim 33

An infusion catheter as in claim 26, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment and wherein the isolated pockets each have an area in the range from 10 mm 2 to 60 mm 2 .

Claim 34

An infusion catheter as in claim 26, wherein the fluid infusion tubes are arranged to form a diamond pattern when the segment is expanded.

Claim 35

An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising: a shaft having a proximal and a distal end and a fluid delivery lumen therethrough; a radially expansible sleeve disposed at the distal end of the shaft, said radially expansible sleeve having a (i) central receptacle for receiving a balloon or the balloon catheter and (ii a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when the sleeve is expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets; and a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

Claim 36

An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising: a shaft having a proximal and a distal end and a fluid delivery lumen therethrough; a radially expansible sleeve disposed at the distal end of the shaft, said radially expansible sleeve having a (i) central receptacle for receiving a balloon or the balloon catheter and (ii a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when the sleeve is expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets; and a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

Claim 37

An infusion catheter as in claim 32, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

Claim 38

An infusion catheter as in claim 32, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment.

Claim 39

An infusion catheter as in claim 32, wherein the isolated pockets each have an area in the range from 10 mm 2 to 60 mm 2 .

Claim 40

An infusion catheter as in claim 32, wherein said radially expansible sleeve has reinforcing ribs within the fluid infusion tube network.

Claim 41

An infusion catheter as in claim 32, wherein the fluid infusion tubes are arranged to form a diamond pattern when the sleeve is expanded.