Passive perfusion angioplasty catheter

Claim 2

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means comprising at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, a band being helically wound about a longitudinal axis of said balloon means, ends of said band being affixed to said flexible member, thereby defining a helical lobe and said helical groove.

Claim 3

The catheter claimed in claim 1, wherein said band is affixed to said flexible member by distal and proximal wraps.

Claim 4

The catheter claimed in claim 1, wherein said balloon means is made from one of polyvinyl chloride, polyethylene, polyethylene terephthalate and polyolefin copolymer.

Claim 5

The catheter claimed in claim 1, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

Claim 6

The catheter claimed in claim 1, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

Claim 7

The catheter claimed in claim 1, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

Claim 8

The catheter claimed in claim 1, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 9

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means including a plurality of lobes defining first and second helical passages.

Claim 10

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means including a plurality of lobes defining first and second helical passages.

Claim 11

The catheter as claimed in claim 8, wherein said helical passages are defined by winding first and second bands helically about said balloon means, said first band being wound helically clockwise about a longitudinal axis of said balloon means, said second band being wound helically counterclockwise about the longitudinal axis of said balloon means, ends of said first and second bands being affixed to said flexible member, said first and second bands also defining said plurality of lobes.

Claim 12

The catheter as claimed in claim 9, wherein said bands are affixed to said flexible member by distal and proximal wraps.

Claim 13

The catheter as claimed in claim 2 or 10, wherein said wraps are made from one of polyethylene terephthalate and polyolefin copolymer.

Claim 14

The catheter as claimed in claim 8, wherein said balloon means is made from one of polyvinyl chloride, polyethylene, polyethylene terephthalate and polyolefin copolymer.

Claim 15

The catheter as claimed in claim 8, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

Claim 16

The catheter as claimed in claim 8, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

Claim 17

The catheter as claimed in claim 8, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

Claim 18

The catheter as claimed in claim 8, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 19

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means comprising at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, said balloon means comprises at least one inflatable lobe portion, said inflatable lobe portion being formed so as to have a material thickness less than remaining portions thereof, whereby during inflation of said balloon means, lobe portions distent to a greater extent than said remaining portions.

Claim 20

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means comprising at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, said balloon means comprises at least one inflatable lobe portion, said inflatable lobe portion being formed so as to have a material thickness less than remaining portions thereof, whereby during inflation of said balloon means, lobe portions distent to a greater extent than said remaining portions.

Claim 21

The catheter as claimed in claim 17, wherein a portion of said balloon means defining said at least one passage has a thickness between 0.006 and 0.012 cm and a portion of said balloon means defining said lobes has a thickness between 0.001 and 0.003 cm, whereby said passage portion expanding less than said lobe portion upon inflation of said balloon means.

Claim 22

The catheter as claimed in claim 17, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

Claim 23

The catheter as claimed in claim 17, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

Claim 24

The catheter as claimed in claim 17, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

Claim 25

The catheter as claimed in claim 17, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 26

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means including a plurality of S-shaped pleats defined in the periphery thereof when said balloon means is in a relaxed state, each said pleat having a radius of curvature of 2.5 to 5 times a thickness of the balloon means material.

Claim 27

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means including a plurality of S-shaped pleats defined in the periphery thereof when said balloon means is in a relaxed state, each said pleat having a radius of curvature of 2.5 to 5 times a thickness of the balloon means material.

Claim 28

The catheter as claimed in claim 23, wherein said pleats have a height of 4r c +δ in said relaxed state, where r c is the radius of curvature of said pleat, and δ is the thickness of said pleat.

Claim 29

The catheter as claimed in claim 23, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

Claim 30

The catheter as claimed in claim 23, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

Claim 31

The catheter as claimed in claim 23, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

Claim 32

The catheter as claimed in claim 23, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 33

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining a plurality of passages between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, at least some of said passages being defined longitudinally and at least some of said passages being defined circumferentially, of said balloon means; and means defining a cavity, said cavity extending longitudinally of said balloon means and being disposed between said balloon means and said flexible member.

Claim 34

A passive perfusion angioplasty catheter comprising: an elongated flexible member defining an inflation lumen; inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining a plurality of passages between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, at least some of said passages being defined longitudinally and at least some of said passages being defined circumferentially, of said balloon means; and means defining a cavity, said cavity extending longitudinally of said balloon means and being disposed between said balloon means and said flexible member.

Claim 35

The catheter as claimed in claim 29, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

Claim 36

The catheter as claimed in claim 29, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

Claim 37

The catheter as claimed in claim 29, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

Claim 38

The catheter as claimed in claim 29, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 39

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, the formed shape consisting of a pleated cylindrical balloon in which the pleats have a radius r c and the polymer has a thickness, δ, and, as cast, the pleated balloon will, when collapsed onto a surface of the core tube of said flexible member give a deflated profile 4r c +δ greater than a radius of said core tube of said flexible member, and when fully inflated will produce a smooth unpleated balloon surface with surface area approximately that of the cast pleated area.

Claim 40

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, the formed shape consisting of a pleated cylindrical balloon in which the pleats have a radius r c and the polymer has a thickness, δ, and, as cast, the pleated balloon will, when collapsed onto a surface of the core tube of said flexible member give a deflated profile 4r c +δ greater than a radius of said core tube of said flexible member, and when fully inflated will produce a smooth unpleated balloon surface with surface area approximately that of the cast pleated area.

Claim 41

A catheter as in claim 34, wherein depending on the polymer chosen, the ratio r c /δ is such that yield strain of the polymer is not exceeded when the pleat is flexed from fully pleated to fully open or unpleated, with 2<r c /δ<5.

Claim 42

A catheter as in claim 34, wherein the pleats are sufficient to prevent formation of wings which exist in a deflated unpleated balloon.

Claim 43

A catheter as claimed in claim 34 wherein the deflated pleated balloon is wrapped by a confining at least one elastomeric band such that when the balloon is inflated to an intermediate pressure, single or multiple helical grooves are formed allowing passage for blood flow while distending artery walls.

Claim 44

A catheter as claimed in claim 37, wherein said at least one elastomeric band is made to stretch with further inflation pressure allowing the balloon to exert a higher distending pressure to the artery momentarily while maintaining diminishing passive perfusion until full inflation is reached, reduction in pressure restoring the flow passage while maintaining distending pressure.

Claim 45

A catheter as claimed in claim 34, wherein the deflated pleated balloon is wrapped by confining at least one axial elastomeric band such that when the balloon is inflated to an intermediate pressure, single or multiple axial grooves are formed by restraining said axial elastomeric band at axial intervals by radial elastomeric bands allowing passage for blood flow while distending artery walls.

Claim 46

A catheter as claimed in claim 39 wherein said at least one elastomeric band is made to stretch with further inflation pressure allowing the balloon to exert a higher distending pressure to the artery momentarily while maintaining diminishing passive perfusion until full inflation is reached, reduction in pressure restoring the flow passage while maintaining distending pressure.

Claim 47

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, said balloon means distending the surrounding arterial walls while allowing an open passage to remain between a distended artery wall and one of a depressed groove and set of grooves formed by the balloon means allowing blood to flow past a surface of the balloon means, said balloon means being fabricated from a polymer having an elastic modulus substantially greater than arterial tissue and is thermally pressure formed to assume a desired shape upon inflation, the formed shape consisting of a partially pleated balloon in which the pleats have a radius r c and the polymer a thickness, δ, as cast the pleated balloon will, when collapsed onto a surface of the interior tube of said flexible member give a deflated profile 4r c +δ greater than a radius of said core tube of said flexible member, and when fully inflated will produce an unpleated balloon surface with surface area approximately that of the cast pleated area and with single or multiple grooves formed by the unpleated, undistended portion of a polymeric tube from which the balloon is blown.

Claim 48

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, said balloon means distending the surrounding arterial walls while allowing an open passage to remain between a distended artery wall and one of a depressed groove and set of grooves formed by the balloon means allowing blood to flow past a surface of the balloon means, said balloon means being fabricated from a polymer having an elastic modulus substantially greater than arterial tissue and is thermally pressure formed to assume a desired shape upon inflation, the formed shape consisting of a partially pleated balloon in which the pleats have a radius r c and the polymer a thickness, δ, as cast the pleated balloon will, when collapsed onto a surface of the interior tube of said flexible member give a deflated profile 4r c +δ greater than a radius of said core tube of said flexible member, and when fully inflated will produce an unpleated balloon surface with surface area approximately that of the cast pleated area and with single or multiple grooves formed by the unpleated, undistended portion of a polymeric tube from which the balloon is blown.

Claim 49

A catheter as claimed in claim 41, wherein the grooves are assured against collapse as inflation pressure is increased by having side walls whose tangents pass on a near side of the catheter centerline and a radial component of stress is maintained by intermittent bands for axial grooves or by adequate pitch when helical grooves are employed.

Claim 50

A catheter as claimed in claim 42, wherein the grooves provide an optimum shape for delivering blood from one side of the balloon to the other, each groove wall has a single tangent and said tangent passes substantially through the catheter centerline, said optimum shape in a filled wedge with a half angle of 37°±2°.

Claim 51

A catheter as claimed in claim 42, wherein the grooves provide an optimum shaped passage for delivering blood from one side of the balloon to the other, said optimum shape being defined for any distribution of side wall slope as the shape providing a maximum hydraulic diameter for the passage bounded by the bottom and side walls of the balloon groove on each side and capped by a taut artery wall on top, said hydraulic diameter being defined as four times the passage cross sectional area divided by the passage perimeter.

Claim 52

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and a manifold connecting inflatable grooved balloon means, distal ends of which being affixed to the core tub while proximal ends thereof being sealed to the concentric tube by way of the manifold such that an interior of the balloon means is a continuation of the inflation lumen, said grooved balloon means distending surrounding arterial walls while allowing an open passage to remain between the distended artery wall and a depressed groove or set of grooves formed by the balloon means and valleys between the balloon means allowing blood to flow past the balloon means surface.

Claim 53

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and a manifold connecting inflatable grooved balloon means, distal ends of which being affixed to the core tub while proximal ends thereof being sealed to the concentric tube by way of the manifold such that an interior of the balloon means is a continuation of the inflation lumen, said grooved balloon means distending surrounding arterial walls while allowing an open passage to remain between the distended artery wall and a depressed groove or set of grooves formed by the balloon means and valleys between the balloon means allowing blood to flow past the balloon means surface.

Claim 54

A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, each balloon having one of a single groove, two groves and three grooves disposed helically or axially with circumferential band pattern.

Claim 55

A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, the balloons being cast as pleated or unpleated elongated circular cylinders with the grooves formed by elastomeric wraps.

Claim 56

A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, the balloons being cast as pleated or unpleated elongated circular cylinders with the grooves formed during a blowing process.

Claim 57

A catheter as claimed in claim 45, wherein flow resistance for a summation of grooves is equal or less than flow resistance distal to an arterial treatment site.

Claim 58

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube defining a lumen; and inflatable balloon means having one of a pleated and unpleated grooved balloon being blown into a mold thereof directly from the lumen, said balloon being sucked into the lumen and threaded to an occluded site where, upon being pressurized, the balloon evaginates forming a grooved balloon providing passive perfusion when opening tightly occluded vessels.

Claim 59

A passive perfusion angioplasty catheter comprising: an elongated flexible member having one of a core tube defining a lumen; and inflatable balloon means having one of a pleated and unpleated grooved balloon being blown into a mold thereof directly from the lumen, said balloon being sucked into the lumen and threaded to an occluded site where, upon being pressurized, the balloon evaginates forming a grooved balloon providing passive perfusion when opening tightly occluded vessels.

Claim 60

A passive perfusion angioplasty catheter as claimed in claim 50 wherein the grooves are assured against collapse as inflation pressure is increased by having side walls whose tangents pass on a near side of the catheter centerline and a radial component of stress is maintained by intermittent bands for axial grooves or by adequate pitch when helical grooves are employed.

Claim 61

A passive perfusion angioplasty catheter as claimed in claim 51 wherein the grooves provide an optimum shaped passage for delivering blood from one side of the balloon to the other, said optimum shape being defined for any distribution of side wall slope as the shape providing a maximum hydraulic diameter for the passage bounded by the bottom and side walls of the balloon groove on each side and capped by a taut artery wall on top, said hydraulic diameter being defined as four times the passage cross sectional area divided by the passage perimeter.

Claim 64

The method as claimed in claim 53, wherein the step of providing a catheter includes providing said balloon means having a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

Claim 67

The method as claimed in claim 55, wherein the step of providing a catheter includes providing said balloon means having a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.