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US5599306A Expired / Lapsed US ⏱️ 0.0 years remaining

Method and apparatus for providing external perfusion lumens on balloon catheters

Assignee: LocalMed Inc
•
Filing: 1995-09-29
•
Granted: 1997-02-04
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Expires: 2015-09-29
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Abstract

Abstract A catheter sleeve includes a radially expansible distal region having a plurality of axial blood perfusion lumens or channels formed thereon. The catheter sleeve may be introduced over a conventional angioplasty balloon catheter with the expansible region lying over the balloon. When the balloon of the angioplasty catheter is expanded, the perfusion lumens will provide a flow path for blood around the expanded balloon. Optionally, the catheter sleeve may further include drug infusion lumens over the radially expansible region. In this way, drugs can be delivered over prolonged periods while the underlying angioplasty balloon is inflated and blood flows through the lumens or channels to perfuse the distal myocardium.

Inventors

  • 👤 Enrique J. Klein
  • 👤 Jordan Bajor
  • 👤 Paul Alba
  • 👤 Aaron V. Kaplan

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 23:21
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61M25/1002; A61M25/0021; A61M25/0023; A61M2025/0025; A61M25/0043; A61M2025/0063; A61M25/01; A61M2025/0183; A61M2025/1004; A61M2025/1043; A61M2025/1072; A61M2025/1079; A61M2025/1081; A61M2025/1095

Claims Analysis

Total Claims: 96
Claim 1
Independent Claim 87 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and at least one perfusion lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports distributed substantially uniformly over its length which permit blood flow through the lumen.
Claim 2
Dependent Claim 87 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and at least one perfusion lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports distributed substantially uniformly over its length which permit blood flow through the lumen.
Claim 3
Dependent Claim 79 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and one or more channels disposed over said radially expansible portion of the tubular body, wherein the channels define flow paths between the tubular body and a surrounding blood vessel wall.
Claim 4
Dependent Claim 79 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and one or more channels disposed over said radially expansible portion of the tubular body, wherein the channels define flow paths between the tubular body and a surrounding blood vessel wall.
Claim 5
Dependent Claim 33 words
A catheter sleeve as in claim 1 or 2, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.
Claim 6
Dependent Claim 24 words
A catheter sleeve as in claim 3, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.
Claim 7
Dependent Claim 29 words
A catheter sleeve as in claim 1, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.
Claim 8
Dependent Claim 21 words
A catheter sleeve as in claim 3, wherein the reinforcing structure comprises a helical wire supporting the interior of the lumen.
Claim 9
Dependent Claim 18 words
A catheter sleeve as in claim 1, further comprising additional lumens having means for infusing therapeutic agents therethrough.
Claim 10
Dependent Claim 37 words
A catheter sleeve as in claim 7, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.
Claim 11
Dependent Claim 33 words
A catheter sleeve as in claim 8, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.
Claim 12
Dependent Claim 26 words
A catheter sleeve as in claim 1, including at least two perfusin lumens wherein the tubular body is slit between the lumens to enhance radial expansibility.
Claim 13
Dependent Claim 19 words
A catheter sleeve as in claim 1, wherein substantially the entire length of the tubular body is radially expansible.
Claim 14
Dependent Claim 36 words
A catheter sleeve as in claim 8 wherein a proximal portion of the catheter body is pleated, rolled, or slit to facilitate passage of a large diameter portion of a balloon catheter through the central lumen.
Claim 15
Dependent Claim 38 words
A catheter sleeve as in claim 1, wherein a proximal portion of the flexible tubular body has side ports to enhance the flow of perfusion liquid through a guiding catheter when the catheter sleeve is in place therein.
Claim 16
Dependent Claim 16 words
A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprise helically arranged flow paths.
Claim 17
Dependent Claim 26 words
A catheter sleeve as in claim 14, further comprising at least one helical drug infusion tube formed over the radially expansible portion of the tubular body.
Claim 18
Dependent Claim 18 words
A catheter sleeve as in claim 14, wherein the tubular body is helically split between said flow paths.
Claim 19
Dependent Claim 48 words
A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprises a pair of adjacent lumens formed on one side of the tubular body, wherein the lumens are separated by a common septum and are split from the remainder of the tubular body to permit radial expansion.
Claim 20
Dependent Claim 16 words
A catheter sleeve as in claim 17, further comprising a radiopaque marker attached to the septum.
Claim 21
Dependent Claim 26 words
A catheter sleeve as in claim 18, wherein the radiopaque marker comprises a pair of plates secured to each other on opposite sides of the septum.
Claim 22
Dependent Claim 28 words
A catheter sleeve as in claim 17, further comprising a plurality of axial spacers on a side of the tubular body opposite to the pair of adjacent lumens.
Claim 23
Dependent Claim 13 words
A catheter sleeve as in claim 20, wherein the spacers have solid cross-section.
Claim 24
Dependent Claim 12 words
A catheter sleeve as in claim 20, wherein the spacers are inflatable.
Claim 25
Dependent Claim 30 words
A catheter sleeve as in claim 1, further comprising a rod having a diameter less than that of the tubular body attached to a proximal end of the tubular body.
Claim 26
Dependent Claim 26 words
A catheter sleeve as in claim 17, wherein axially spaced-apart hinges are formed in the tubular body along the adjacent pair of lumens to enhance flexibility.
Claim 27
Dependent Claim 46 words
A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprises a triple lumen blood perfusion tube formed over the tubular body, wherein a center lumen includes perfusion ports and the two flanking lumens are closed to permit inflation to selectively reinforce the center lumen.
Claim 28
Dependent Claim 57 words
A catheter sleeve as in claim 25, wherein the blood perfusion tube is arranged helically over the tubular body, further comprising a helical drug infusion tube disposed opposite to the blood perfusion tube over the tubular body, wherein the tubular body is split between the blood perfusion tube and the drug infusion tube to permit radial expansion.
Claim 29
Dependent Claim 24 words
A catheter sleeve as in claim 1, wherein the lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.
Claim 30
Dependent Claim 29 words
A catheter sleeve as in claim 27, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.
Claim 31
Independent Claim 104 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover, wherein said flow path provides both axial flow and radially inward and outward flow over substantially its entire length; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path and radially in and out of the flow path over substantially the entire expanded length of the sleeve.
Claim 32
Independent Claim 104 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover, wherein said flow path provides both axial flow and radially inward and outward flow over substantially its entire length; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path and radially in and out of the flow path over substantially the entire expanded length of the sleeve.
Claim 33
Dependent Claim 29 words
A method as in claim 29, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.
Claim 34
Dependent Claim 23 words
A method as in claim 30, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.
Claim 35
Dependent Claim 25 words
A method as in claim 29, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.
Claim 36
Dependent Claim 28 words
A method as in claim 29, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.
Claim 37
Dependent Claim 34 words
A method as in claim 29, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.
Claim 38
Independent Claim 89 words
A method for delivering a therapeutic agent to a treatment site on an interior wall of a blood vessel, said method comprising: positioning a sleeve at said treatment site, said sleeve having a plurality of axial flow paths thereover; radially expanding the sleeve to contact an exterior surface thereof against the interior wall of the blood vessel; and infusing the therapeutic agent through at least some of the flow paths to the blood vessel wall, wherein others of said flow paths establish blood perfusion past the radially expanded sleeve.
Claim 39
Independent Claim 89 words
A method for delivering a therapeutic agent to a treatment site on an interior wall of a blood vessel, said method comprising: positioning a sleeve at said treatment site, said sleeve having a plurality of axial flow paths thereover; radially expanding the sleeve to contact an exterior surface thereof against the interior wall of the blood vessel; and infusing the therapeutic agent through at least some of the flow paths to the blood vessel wall, wherein others of said flow paths establish blood perfusion past the radially expanded sleeve.
Claim 40
Dependent Claim 28 words
A method as in claim 35, further comprising positioning a balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.
Claim 41
Dependent Claim 23 words
A method as in claim 36, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.
Claim 42
Dependent Claim 26 words
A method as in claim 35, wherein the sleeve is positioned at the treatment site after an angioplasty procedure has been performed at the same site.
Claim 43
Dependent Claim 57 words
An improved method for treating a target location within a blood vessel, said method being of the type wherein a balloon is expanded against an interior wall of the blood vessel, wherein the improvement comprises providing radially open perfusion flow paths over an outer surface of the balloon, whereby blood flow is established through said perfusion paths.
Claim 44
Dependent Claim 57 words
An improved method for treating a target location within a blood vessel, said method being of the type wherein a balloon is expanded against an interior wall of the blood vessel, wherein the improvement comprises providing radially open perfusion flow paths over an outer surface of the balloon, whereby blood flow is established through said perfusion paths.
Claim 45
Dependent Claim 31 words
An improved method as in claim 39, further comprising providing drug infusion lumens disposed over an outside surface of the balloon and infusing a therapeutic agent therethrough to the target location.
Claim 46
Dependent Claim 36 words
An improved method as in claim 39, wherein the perfusion flow paths are provided by positioning a catheter sleeve over the balloon, wherein the catheter sleeve is radially expansible and includes said perfusion flow paths thereon.
Claim 47
Dependent Claim 26 words
An improved method as in claim 39, wherein the balloon is expanded by inflating to a pressure in the range from 0.5 atm to 16 atm.
Claim 48
Dependent Claim 72 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is axially split to permit radial expansion as a result of a radial expansion force applied in the central lumen within said portion; and means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow.
Claim 49
Dependent Claim 72 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is axially split to permit radial expansion as a result of a radial expansion force applied in the central lumen within said portion; and means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow.
Claim 50
Dependent Claim 44 words
A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises at least one perfusion lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.
Claim 51
Dependent Claim 29 words
A catheter sleeve as in claim 43, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.
Claim 52
Dependent Claim 19 words
A catheter sleeve as in claim 45, wherein reinforcing structure comprising a helical wire supporting interior of the lumen.
Claim 53
Dependent Claim 26 words
A catheter sleeve as in claim 44, including at least two prefusion lumens wherein the tubular body is slit between the lumens to enhance radial expansibility.
Claim 54
Dependent Claim 42 words
A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises one or more channels disposed over said radially expansible portion of the tubular body, wherein the channels define flow paths between the tubular body and a surrounding blood vessel wall.
Claim 55
Dependent Claim 33 words
A catheter sleeve as in claim 43 or 48, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.
Claim 56
Dependent Claim 24 words
A catheter sleeve as in claim 49, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.
Claim 57
Dependent Claim 38 words
A catheter sleeve as in claim 43, wherein a proximal portion of the flexible tubular body has side ports to enhance the flow of perfusion liquid through a guiding catheter when the catheter sleeve is in place therein.
Claim 58
Dependent Claim 16 words
A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprise helically arranged flow paths.
Claim 59
Dependent Claim 26 words
A catheter sleeve as in claim 52, further comprising at least one helical drug infusion tube formed over the radially expansible portion of the tubular body.
Claim 60
Dependent Claim 18 words
A catheter sleeve as in claim 52, wherein the tubular body is helically split between said flow paths.
Claim 61
Dependent Claim 48 words
A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises a pair of adjacent lumens formed on one side of the tubular body, wherein the lumens are separated by a common septum and are split from the remainder of the tubular body to permit radial expansion.
Claim 62
Dependent Claim 30 words
A catheter sleeve as in claim 43, further comprising a rod having a diameter less than that of the tubular body attached to a proximal end of the tubular body.
Claim 63
Dependent Claim 46 words
A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises a triple lumen blood perfusion tube formed over the tubular body, wherein a center lumen includes perfusion ports and the two flanking lumens are closed to permit inflation to selectively reinforce the center lumen.
Claim 64
Dependent Claim 18 words
A catheter sleeve as in claim 43, further comprising additional lumens having means for infusing therapeutic agents therethrough.
Claim 65
Dependent Claim 37 words
A catheter sleeve as in claim 58, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.
Claim 66
Dependent Claim 33 words
A catheter sleeve as in claim 59, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.
Claim 67
Independent Claim 88 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover and being axially split in the region of the flow path; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path, wherein radial expansion causes circumferential separation of the axial split(s).
Claim 68
Independent Claim 88 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover and being axially split in the region of the flow path; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path, wherein radial expansion causes circumferential separation of the axial split(s).
Claim 69
Dependent Claim 29 words
A method as in claim 61, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.
Claim 70
Dependent Claim 23 words
A method as in claim 61, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.
Claim 71
Dependent Claim 25 words
A method as in claim 61, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.
Claim 72
Dependent Claim 28 words
A method as in claim 61, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.
Claim 73
Dependent Claim 34 words
A method as in claim 61, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.
Claim 74
Dependent Claim 75 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and at least one perfusion lumen integrally formed as a single extrusion as part of the tubular body near the distal end for establishing blood perfusion flow.
Claim 75
Dependent Claim 75 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and at least one perfusion lumen integrally formed as a single extrusion as part of the tubular body near the distal end for establishing blood perfusion flow.
Claim 76
Dependent Claim 31 words
A catheter sleeve as in claim 67, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.
Claim 77
Dependent Claim 24 words
A catheter sleeve as in claim 68, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.
Claim 78
Dependent Claim 28 words
A catheter sleeve as in claim 66, including at least two integrally formed perfusion lumens, wherein the tubular body is slit between the lumens to enhance radial expansibility.
Claim 79
Dependent Claim 20 words
A catheter sleeve as in claim 67, further comprising additional integrally formed lumens having means for infusing therapeutic agents therethrough.
Claim 80
Independent Claim 73 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve including at least one perfusion lumen integrally formed as a single extrusion thereover; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one perfusion lumen.
Claim 81
Independent Claim 73 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: positioning a sleeve having a central lumen at said treatment site, said sleeve including at least one perfusion lumen integrally formed as a single extrusion thereover; and applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one perfusion lumen.
Claim 82
Dependent Claim 34 words
A method as in claim 72, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.
Claim 83
Dependent Claim 29 words
A method as in claim 72, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.
Claim 84
Dependent Claim 23 words
A method as in claim 74, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.
Claim 85
Dependent Claim 25 words
A method as in claim 72, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.
Claim 86
Dependent Claim 28 words
A method as in claim 72, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.
Claim 87
Independent Claim 91 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: inflating a balloon catheter to dilate a blood vessel treatment site to an initial inflation perimeter; deflating the balloon; positioning a sleeve having a central lumen over the deflated balloon at said treatment site, said sleeve defining at least one flow path thereover; and reinflating the balloon within the sleeve at low pressure in the range from 0.5 atm to 5 atm for a prolonged period to preserve the initial inflation perimeter of the balloon.
Claim 88
Independent Claim 91 words
A method for perfusing blood past a treatment site within a blood vessel, said method comprising: inflating a balloon catheter to dilate a blood vessel treatment site to an initial inflation perimeter; deflating the balloon; positioning a sleeve having a central lumen over the deflated balloon at said treatment site, said sleeve defining at least one flow path thereover; and reinflating the balloon within the sleeve at low pressure in the range from 0.5 atm to 5 atm for a prolonged period to preserve the initial inflation perimeter of the balloon.
Claim 89
Dependent Claim 86 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow; and means over the radially expansible portion of the tubular body near the distal end for infusing therapeutic agents.
Claim 90
Dependent Claim 86 words
A catheter sleeve comprising: a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow; and means over the radially expansible portion of the tubular body near the distal end for infusing therapeutic agents.
Claim 91
Dependent Claim 43 words
A catheter sleeve as in claim 79, wherein the perfusion-flow-establishing means comprises at least one lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.
Claim 92
Dependent Claim 31 words
A catheter sleeve as in claim 80, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.
Claim 93
Dependent Claim 24 words
A catheter sleeve as in claim 81, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.
Claim 94
Dependent Claim 26 words
A catheter sleeve as in claim 79, wherein the therapeutic agent infusing means comprises at least one infusion lumen having means for releasing the agent therethrough.
Claim 95
Dependent Claim 37 words
A catheter sleeve as in claim 83, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.
Claim 96
Dependent Claim 33 words
A catheter sleeve as in claim 84, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.

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