Concentric independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems and method of use

Claim 2

A catheter (10) for performing balloon angioplasty, characterized by: an elongate, flexible catheter shaft (12) having a plurality of lumens (22, 24, 26) therethrough; a plurality of imperforate angioplasty balloons (16, 20) on said shaft (12), with the interior of each of said balloons connected to a different one of said lumens (24, 26) for separate inflation and deflation, each of said balloons (16, 20) having a predetermined maximum inflated diameter and being formed of non-­elastomeric material, said balloons (16, 20) being capable of substantially maintaining said predetermined maximum inflated diameter at inflation pressures of 100 psi; said balloons comprising: a first balloon (16) on said catheter shaft (12) near the distal end thereof; and a second balloon (20) on said catheter shaft (12) on top of said first balloon (16), so that said first balloon (16) is at least partially inside said second balloon (20), said second balloon (20) having an uninflated thickness, and the maximum inflated diameter of said first balloon (16) is less than the maximum inflated diameter of said second balloon (20), so that the catheter (10) has two different fixed working diameters for dilating stenoses at a single point at the distal end (14) thereof, one of said working diameters corresponding to the maximum inflated diameter of said first balloon (16) plus the uninflated thickness of said second balloon (20) over said first balloon (16), and the other of said working diameters corresponding to the maximum inflated diameter of said second balloon (20).

Claim 3

The catheter (10) of Claim 1, further characterized in that said first balloon (16) is completely inside said second balloon (20).

Claim 4

A catheter (10) for performing balloon angioplasty, characterized by: an elongate, flexible catheter shaft (12) having a plurality of lumens (22, 24, 26) therethrough; a plurality of imperforate angioplasty balloons (16, 20) on said shaft (12), with the interior of each of said balloons (16, 20) connected to a different one of said lumens for separate inflation and deflation, each of said balloons (16, 20) having a predetermined maximum inflated diameter and being formed of non-­elastomeric material, said balloons (16, 20) being capable of substantially maintaining said predetermined maximum inflated diameter at inflation pressures of 100 psi; said balloons comprising: a first balloon (16) on said catheter shaft (12) near the distal end (14) thereof; a second balloon (20) on said catheter shaft (12) on top of said first balloon (16), said second balloon (20) having an uninflated thickness, so that said first balloon (16) is at least partially inside said second balloon (20), and the maximum inflated diameter of said first balloon (16) is less than the maximum inflated diameter of said second balloon (20); and a third balloon (42) on said catheter shaft (12) distal of but adjacent to said first balloon (16) and said second balloon (20), and the maximum inflated diameter of said third balloon (42) is smaller than the maximum inflated diameter of said first balloon (16), so that said catheter (10) has two different fixed working diameters for dilating stenoses at a first point at the distal end (14) thereof and a third different fixed working diameter for dilating stenoses at a second point which is distal of said first point, one of said working diameters corresponding to the maximum inflated diameter of said first balloon (16) plus the uninflated thickness of said second balloon (20) over said first balloon (16), another of said working diameters corresponding to the maximum inflated diameter of said second balloon (20), and the third said effective working diameter corresponding to the maximum inflated diameter of said third balloon (42).

Claim 5

A catheter (10) for performing balloon angioplasty, characterized by: an elongate, flexible catheter shaft (12) having a plurality of lumens (22, 24, 26) therethrough; a plurality of imperforate angioplasty balloons (16, 20) on said shaft (12), with the interior of each of said balloons (16, 20) connected to a different one of said lumens for separate inflation and deflation, each of said balloons (16, 20) having a predetermined maximum inflated diameter and being formed of non-­elastomeric material, said balloons (16, 20) being capable of substantially maintaining said predetermined maximum inflated diameter at inflation pressures of 100 psi; said balloons comprising: a first balloon (16) on said catheter shaft (12) near the distal end (14) thereof; a second balloon (20) on said catheter shaft (12) on top of said first balloon (16), said second balloon (20) having an uninflated thickness, so that said first balloon (16) is at least partially inside said second balloon (20), and the maximum inflated diameter of said first balloon (16) is less than the maximum inflated diameter of said second balloon (20); and a third balloon (42) on said catheter shaft (12) distal of but adjacent to said first balloon (16) and said second balloon (20), and the maximum inflated diameter of said third balloon (42) is smaller than the maximum inflated diameter of said first balloon (16), so that said catheter (10) has two different fixed working diameters for dilating stenoses at a first point at the distal end (14) thereof and a third different fixed working diameter for dilating stenoses at a second point which is distal of said first point, one of said working diameters corresponding to the maximum inflated diameter of said first balloon (16) plus the uninflated thickness of said second balloon (20) over said first balloon (16), another of said working diameters corresponding to the maximum inflated diameter of said second balloon (20), and the third said effective working diameter corresponding to the maximum inflated diameter of said third balloon (42).

Claim 6

The catheter (10) of Claim 3, further characterized by an attachment site (46) on said catheter shaft (12) to which the proximal end of said third balloon (42) and the distal end of said second balloon (20) are joined, and one of said second balloon (20) and said third balloon (42) has been formed to permanently prolapse at least partially over said attachment site (46).

Claim 7

The catheter (10) of Claim 3, further characterized by an attachment site (46) on said catheter shaft (12) to which the distal end of said second balloon (20) is attached, and the proximal end of said third balloon (42) is attached to the wall of said second balloon (20) proximally of said attachment site on said catheter shaft (12).

Claim 8

The catheter (10) of Claim 3, further characterized by a fourth balloon (52) on top of said third balloon (42), so that said third balloon (42), is at least partially inside said fourth balloon (52), and the maximum inflated diameter of said fourth balloon (52) being greater than the maximum inflated diameter of said third balloon (42), but less than the maximum inflated diameter of said first balloon (16).

Claim 9

The catheter (10) of Claim 3, further characterized by a fourth balloon (52) distal of but adjacent to said third balloon (42), and the maximum inflated diameter of said fourth balloon (52) being smaller than the maximum inflated diameter of said third balloon (42).

Claim 10

The catheter (10) of Claim 7, further characterized by a first attachment site (46) of said catheter shaft (12) to which the distal end of said second balloon (20) is attached and a second attachment site on said catheter shaft (12) to which the distal end of said third balloon (42) is attached, the proximal end of said third balloon (42) is bonded to the wall of said second balloon (20) distally of said first attachment site (46), and that the proximal end of said fourth balloon (52) is bonded to the wall of said third balloon (42) distally of said second attachment site.

Claim 11

The catheter (10) of Claim 1, further characterized by a third balloon (42) on said catheter shaft (12) on top of said second balloon (20), so that said second balloon (20) is at least partially inside said third balloon (42), and the maximum inflated diameter of said second balloon (20) is less than the maximum inflated diameter of said third balloon (42).

Claim 12

The catheter (10) of Claim 9, further characterized in that said first balloon (16) is completely inside said second balloon (20) and said second balloon (20) is completely inside said third balloon (42).

Claim 13

The catheter (10) of any of Claims 1-10, further characterized in that said ballrooms are capable of substantially maintaining said predetermined maximum inflated diameter at inflation pressures of 150 psi.

Claim 14

The catheter (10) of any of Claims 1-11, further characterized by a radiopaque marker 44 on said catheter (10) at the longitudinal location of at least one of said balloons (16, 20, 42).

Claim 15

The catheter (10) of any of Claims 1-12, further characterized in that the length of each of said balloons (16, 20, 42) does not exceed 40 mm.

Claim 16

The catheter (10) of any of Claims 1-13, further characterized in that the maximum inflated diameter of each of said balloons (16, 20, 42) does not exceed 4.5 mm.

Claim 17

The catheter (10) of any of Claims 1-12, further characterized in that the length of each of said balloons (16, 20, 42) does not exceed 80 mm.

Claim 18

The catheter (10) of any of Claims 1-12 or 15, further characterized in that the maximum inflated diameter of each of said balloons (16, 20, 42) does not exceed 15 mm.

Claim 19

The catheter (10) of any of Claims 1-16, further characterized in that, when said balloons (16, 20, 42) are deflated, the diameter of said catheter (10) through said balloons (16, 20, 42) does not exceed 2.0 mm.

Claim 20

The catheter (10) of any of Claims 1-17, further characterized by a central lumen extending longitudinally through said catheter shaft (12) and through all of said balloons (16, 20, 42) for receiving a steerable guidewire.

Claim 21

The catheter (10) of Claim 18, further characterized by means (36) for permitting the flow of blood through said catheter shaft (12) past said balloons (16, 20, 42).

Claim 22

The catheter (10) of any of Claims 1-17, further characterized by an axial torque guidewire (34) extending through said catheter shaft (12) and out of the distal end thereof, the proximal ends of at least two of said balloons (16, 20, 42) being bonded to the distal end of said catheter shaft (12) and the distal ends of at least two of said balloons (16, 20, 42) being bonded to said wire (34).

Claim 23

The catheter (10) of Claim 9, further characterized by an axial torque guidewire (34) extending through said catheter shaft (12) and extending out of the distal end of said catheter shaft (12), the distal ends of said first, second, and third balloon (42) being bonded to said wire (34).

Claim 24

The catheter (10) of Claim 3, further characterized in that said second balloon (20) and said third balloon (42) are formed of a single, continuous tube of polymer material.