Perfusion balloon angioplasty catheter

Claim 2

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen having a distal end extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope; the improvement which comprises a projecting balloon assembly tip integrally formed with the balloon envelope and extending beyond the distal end of the perfusion lumen to define a discharge lumen, the integral projecting tip including a side wall, tapering radially inwardly in a distal direction, having at least one generally elliptical perfusion discharge orifice, elongated along an axis generally parallel to a longitudinal axis of the projecting balloon assembly tip, formed therein.

Claim 3

The balloon angioplasty catheter of claim 1 further comprising a second lumen for removably inserting a guide wire into the catheter, that extends through the balloon envelope and distally through the projecting integral tip, the projecting integral tip having a plurality of generally elliptical discharge orifices through the side wall.

Claim 4

The balloon angioplasty catheter of claim 2 wherein the discharge orifices have their major dimension generally aligned with the direction of projection of the integral tip.

Claim 5

The balloon angioplasty catheter of claim 3 wherein the aspect ratio of the generally elliptical discharge orifices is 1.5 to 1.0.

Claim 6

The balloon angioplasty catheter of claim 2 wherein the projecting integral tip has a region of discharge-facilitating distally decreasing cross-section.

Claim 7

The balloon angioplasty catheter of claim 5 wherein the discharge orifices are generally elliptical having their major dimension generally aligned with the direction of projection of the integral tip and are located in the region of distally decreasing cross-section.

Claim 8

The balloon angioplasty catheter of claim 6 wherein the aspect ratio of the generally elliptical orifices is 1.5 to 1.0.

Claim 9

The balloon angioplasty catheter of claim 1 wherein the perfusion lumen is formed of an encapsulating flexible material supported against collapse during balloon envelope inflation by a support member having spaced elements.

Claim 10

The balloon angioplasty catheter of claim 8 wherein the support member is a helical member formed of wound ribbon.

Claim 11

The balloon angioplasty catheter of claim 9 wherein the flexible material encapsulates the helical member along its length.

Claim 12

The balloon angioplasty catheter of claim 9 wherein the helical member includes spaced coils having a pitch that is selected to avoid coil-to-coil contact during traverse of a body vessel.

Claim 13

The balloon angioplasty catheter of claim 9 wherein the helical member is a surgical grade stainless steel.

Claim 14

The balloon angioplasty catheter of claim 9 wherein the helical member is radiopaque.

Claim 15

The balloon angioplasty catheter of claim 1 wherein the balloon assembly includes a proximal tubular waist extension having inner cross-sectional dimensions greater than the outside dimensions of the catheter body distal end, the catheter body distal end being secured within the balloon assembly waist extension to define an axial flow opening to the perfusion lumen.

Claim 16

The balloon angioplasty catheter of claim 14 wherein the balloon assembly waist is skived to elongate the flow opening in the direction of flow.

Claim 17

The balloon angioplasty catheter of claim 14 wherein the balloon assembly waist and catheter body distal end are skived to elongate the flow opening in the direction of flow.

Claim 18

In a balloon angioplasty catheter of the type having a balloon, means for inflating the balloon, and a perfusion lumen extending through the balloon to provide a blood flow passage during balloon inflation and a blood discharge lumen extending distally of the balloon, the discharge lumen including at least one side discharge orifice; the improvement wherein said discharge lumen is defined by a side wall, tapering radially inwardly in a distal direction, and wherein said at least one side discharge orifice is elongated along an axis, generally parallel to a longitudinal axis of extension of the discharge lumen, and is formed in said side wall.

Claim 19

In a balloon angioplasty catheter of the type having a balloon, means for inflating the balloon, and a perfusion lumen extending through the balloon to provide a blood flow passage during balloon inflation and a blood discharge lumen extending distally of the balloon, the discharge lumen including at least one side discharge orifice; the improvement wherein said discharge lumen is defined by a side wall, tapering radially inwardly in a distal direction, and wherein said at least one side discharge orifice is elongated along an axis, generally parallel to a longitudinal axis of extension of the discharge lumen, and is formed in said side wall.

Claim 20

The balloon angioplasty catheter of claim 17 wherein the elongated discharge orifice is generally elliptical.

Claim 21

The balloon angioplasty catheter of claim 18 wherein the aspect ratio of the generally elliptical orifices is 1.5 to 1.0.

Claim 22

The balloon angioplasty catheter of claim 17 wherein the discharge lumen has a region of discharge-flow-facilitating, distally-decreasing cross-section.

Claim 23

The balloon angioplasty catheter of claim 20 wherein the elongated discharge orifice is generally elliptical.

Claim 24

The balloon angioplasty catheter of claim 21 wherein the aspect ratio of the generally elliptical orifices is 1.5 to 1.0.

Claim 25

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending, during catheter installation, from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises a projecting balloon assembly tip integrally formed with the balloon envelope and extending beyond the distal end of the perfusion lumen to define the discharge lumen in fluid communication with the perfusion lumen, the integral projecting tip including at least one perfusion discharge orifice formed therethrough, and a tip distal end defining a gate through which the guide wire, during catheter installation, passes, the gate being biased to a closed position so that, when the guide wire is withdrawn from a disposition passing through the perfusion lumen, the gate closes, and further including an axially-displaceable, collapsible guide wire tube, through which the guide wire, during installation, extends, extending distally from the catheter body, through the perfusion lumen, and into the projecting integral tip, the projecting integral tip having a plurality of side discharge perfusion orifices, the axially-displaceable guide wire tube collapsing upon withdrawal of the guide wire.

Claim 26

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending, during catheter installation, from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises a projecting balloon assembly tip integrally formed with the balloon envelope and extending beyond the distal end of the perfusion lumen to define the discharge lumen in fluid communication with the perfusion lumen, the integral projecting tip including at least one perfusion discharge orifice formed therethrough, and a tip distal end defining a gate through which the guide wire, during catheter installation, passes, the gate being biased to a closed position so that, when the guide wire is withdrawn from a disposition passing through the perfusion lumen, the gate closes, and further including an axially-displaceable, collapsible guide wire tube, through which the guide wire, during installation, extends, extending distally from the catheter body, through the perfusion lumen, and into the projecting integral tip, the projecting integral tip having a plurality of side discharge perfusion orifices, the axially-displaceable guide wire tube collapsing upon withdrawal of the guide wire.

Claim 27

The balloon angioplasty catheter of claim 23 wherein the side discharge perfusion orifices are generally oval having their major dimension generally aligned with the direction of projection of the integral tip.

Claim 28

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending through an axially-displaceable guide wire tube, during catheter installation, from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises means for metering perfusion through the perfusion lumen and discharge lumen including a valve member carried by the displaceable guide wire tube and selectively movable, relative to a distal end of the discharge lumen by axial movement of the displaceable guide wire tube, between a first position, wherein perfusion through the perfusion lumen and the discharge lumen is precluded, and at least one second position, wherein perfusion through the perfusion lumen and the discharge lumen is afforded.

Claim 29

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending through an axially-displaceable guide wire tube, during catheter installation, from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises means for metering perfusion through the perfusion lumen and discharge lumen including a valve member carried by the displaceable guide wire tube and selectively movable, relative to a distal end of the discharge lumen by axial movement of the displaceable guide wire tube, between a first position, wherein perfusion through the perfusion lumen and the discharge lumen is precluded, and at least one second position, wherein perfusion through the perfusion lumen and the discharge lumen is afforded.

Claim 30

The balloon angioplasty catheter of claim 25 wherein the valve member comprises a radially expanded element carried by the displaceable guide wire tube at a location therealong distal with respect to the distal end of the discharge lumen, the radially expanded element carried by the displaceable guide wire tube having a cross-sectional shape and area sufficient to define a shoulder engagable with the distal end of the discharge lumen to restrict and occlude egress flow through the discharge lumen when the displaceable guide wire tube is withdrawn with respect to an extended position thereof.

Claim 31

The balloon angioplasty catheter of claim 26 wherein the radially expanded element is selectively expandable and contractable.

Claim 32

The balloon angioplasty catheter of claim 27 further comprising means for selectively expanding and contracting the radially expanded element.

Claim 33

The balloon angioplasty catheter of claim 28 wherein the means for selectively expanding and contracting the radially expanded element comprises a resilient envelope inflatable by injection of fluid into the envelope.

Claim 34

The balloon angioplasty catheter of claim 28 wherein the means for selectively expanding and contracting the radially expanded element comprises an elastomeric envelope normally expanded radially to have a size and shape so as to restrict and occlude egress flow through the discharge lumen, the elastomeric envelope having a proximal axial end positionable axially proximate the distal end of the discharge lumen, and a distal axial end fixed to the displaceable guide wire tube at a location spaced outwardly from the distal end of the discharge lumen, wherein, as the distal axial end of the elastomeric envelope fixed to the displaceable guide wire tube is urged outwardly in a directly of perfusion flow through the perfusion lumen, the elastomeric envelope becomes elongated axially and, commensurately, deformed radially inwardly to afford egress flow through the discharge lumen.

Claim 35

The balloon angioplasty catheter of claim 26 wherein the valve member comprises a sleeve mounted to the displaceable guide wire tube generally concentrically enclosing the displaceable guide wire tube, the sleeve having a closed distal end by which it is mounted to the displaceable guide wire tube, an open proximal end, and an outer wall with a cross section approximating a cross section of the discharge lumen, and at least one port formed therethrough, wherein, in one axial position of the displaceable guide wire tube, the at least one port formed in the wall of the sleeve is occluded by the discharge lumen and, in an outward axially displaced position of the displaceable guide wire tube, the at least one port in the wall of the sleeve is unoccluded to afford fluid flow therethrough.

Claim 36

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises a guide wire having a cross section smaller than the discharge lumen so as to not fully preclude egress flow through the discharge lumen even when the guide wire is positioned extending through the discharge lumen, and an axially-displaceable guide wire tube encircling the guide wire and having a cross section, relative to a cross section of the discharge lumen, to restrict flow through the discharge lumen, the displaceable guide wire tube being movable axially so that, when a distal end thereof is brought into engagement with a shoulder defined at a proximal end of the discharge lumen, egress flow through the discharge lumen is precluded.

Claim 37

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body and means for inflating a balloon envelope of said assembly, the balloon assembly including said balloon envelope and a perfusion lumen extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope, and the catheter having a guide wire extending from the catheter body to a discharge lumen through the perfusion lumen; the improvement which comprises a guide wire having a cross section smaller than the discharge lumen so as to not fully preclude egress flow through the discharge lumen even when the guide wire is positioned extending through the discharge lumen, and an axially-displaceable guide wire tube encircling the guide wire and having a cross section, relative to a cross section of the discharge lumen, to restrict flow through the discharge lumen, the displaceable guide wire tube being movable axially so that, when a distal end thereof is brought into engagement with a shoulder defined at a proximal end of the discharge lumen, egress flow through the discharge lumen is precluded.

Claim 38

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body, the catheter body including an inflation lumen, the balloon assembly including an inflatable balloon envelope in fluid communication with said inflation lumen and a perfusion lumen having a distal end extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope; the improvement which comprises a projecting balloon assembly tip integrally formed with the balloon envelope and extending beyond the distal end of the perfusion lumen to define a discharge lumen, the integral projecting tip including a side wall having at least one generally elliptical perfusion discharge orifice, wherein the balloon assembly includes a proximal tubular waist extension having inner cross-sectional dimensions greater than the outside dimensions of the catheter body distal end, the catheter body distal end being secured within the balloon assembly waist extension to define an axial flow opening to the perfusion lumen.

Claim 39

In a balloon angioplasty catheter of the type having a balloon assembly carried at a distal end of an elongated catheter body, the catheter body including an inflation lumen, the balloon assembly including an inflatable balloon envelope in fluid communication with said inflation lumen and a perfusion lumen having a distal end extending through the balloon envelope to provide a blood flow passage during inflation of the balloon envelope; the improvement which comprises a projecting balloon assembly tip integrally formed with the balloon envelope and extending beyond the distal end of the perfusion lumen to define a discharge lumen, the integral projecting tip including a side wall having at least one generally elliptical perfusion discharge orifice, wherein the balloon assembly includes a proximal tubular waist extension having inner cross-sectional dimensions greater than the outside dimensions of the catheter body distal end, the catheter body distal end being secured within the balloon assembly waist extension to define an axial flow opening to the perfusion lumen.