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US5545132A Expired / Lapsed US ⏱️ 0.0 years remaining

Helically grooved balloon for dilatation catheter and method of using

Assignee: Medtronic Vascular Inc
•
Filing: 1993-12-21
•
Granted: 1996-08-13
•
Expires: 2013-12-21
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Abstract

Abstract A dilatation balloon having at least one helical groove disposed in at least a portion of the dilating surface of the dilatation balloon is mounted on the distal end of a catheter shaft. Multiple helical grooves may be provided in the dilatation balloon extending parallel to each other or opposite to each other in the dilating surface. Each helical groove has a pitch, width and depth. According to one aspect of the invention, the pitch, width and depth of the helical groove, as well as the number of grooves, are selected to allow perfusion of blood past the dilatation catheter when the dilatation balloon is inflated in a blood vessel. According to another aspect of the invention, the pitch, width, and depth of the helical groove, as well as the number of grooves, are selected so that the dilatation balloon conforms to a tortuous blood vessel and does not straighten the blood vessel during dilation. According to another aspect of the invention, the pitch, width, and depth of the helical groove, as well as the number of grooves, are selected to control the diametrical compliance of the dilatation balloon. The pitch, width, and depth of the helical groove may be selected to provide both conformance to the shape of tortuous blood vessels and diametrical compliance. The helical groove also permits the dilatation balloon to deflate without "winging", i.e., forming undesirable flat folds that extend outward from the rest of the catheter.

Inventors

  • 👤 John R. Fagan
  • 👤 Jeffrey Kling

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 18:45
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1002; A61M25/104; A61M2025/1043; A61M2025/1086; A61M2025/1097

Claims Analysis

Total Claims: 76
Claim 1
Independent Claim 117 words
A method of dilating a blood vessel with a dilatation catheter comprising the steps of: positioning in the blood vessel a dilatation catheter having a limited compliance dilatation balloon dimensioned to dilate the lumen of the blood vessel when inflated, the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface, the portion of the balloon that defines the groove being constructed to deflect and cause the groove to diminish in depth with increased inflation pressure to enable the effective dilating diameter of the balloon to increase within a limited range of diameters; and inflating the limited compliance dilatation balloon to dilate the blood vessel.
Claim 2
Independent Claim 117 words
A method of dilating a blood vessel with a dilatation catheter comprising the steps of: positioning in the blood vessel a dilatation catheter having a limited compliance dilatation balloon dimensioned to dilate the lumen of the blood vessel when inflated, the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface, the portion of the balloon that defines the groove being constructed to deflect and cause the groove to diminish in depth with increased inflation pressure to enable the effective dilating diameter of the balloon to increase within a limited range of diameters; and inflating the limited compliance dilatation balloon to dilate the blood vessel.
Claim 3
Dependent Claim 31 words
The method of claim 1 further comprising a step of varying the diameter of the limited compliance dilatation balloon by varying the pressure of an inflation fluid in the dilatation balloon.
Claim 4
Dependent Claim 29 words
The method of claim 2, wherein the diameter of the limited compliance dilatation balloon varies as a linear function of the pressure until a predetermined maximum diameter is reached.
Claim 5
Dependent Claim 18 words
The method of claim 3 wherein the limited compliance dilatation balloon is constructed of a substantially non-compliant material.
Claim 6
Dependent Claim 11 words
The method of claim 4, wherein the material is polyethylene terephthalate.
Claim 7
Dependent Claim 38 words
The method of claim 1 wherein the blood vessel is curved and wherein the limited compliance dilatation balloon, when inflated, conforms to the curvature of the blood vessel and dilates the blood vessel without straightening the blood vessel.
Claim 8
Dependent Claim 24 words
The method of claim 3, further comprising the step of providing perfusion of blood through the helical groove during dilation of the blood vessel.
Claim 9
Dependent Claim 117 words
A dilatation catheter comprising: a catheter shaft having a distal end; a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon being dimensioned to dilate a lumen of a blood vessel when inflated; the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the at least one helical groove includes at least one of a pitch, width and depth selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter of the balloon to increase, thereby to control the effective dilating diameter of the balloon.
Claim 10
Dependent Claim 117 words
A dilatation catheter comprising: a catheter shaft having a distal end; a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon being dimensioned to dilate a lumen of a blood vessel when inflated; the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the at least one helical groove includes at least one of a pitch, width and depth selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter of the balloon to increase, thereby to control the effective dilating diameter of the balloon.
Claim 11
Dependent Claim 40 words
The dilatation catheter of claim 8 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.
Claim 12
Dependent Claim 39 words
The dilatation catheter of claim 9 wherein the at least one helical groove is disposed in each of a plurality of selected portions of the dilating surface of the balloon to provide a plurality of zones of diametrical compliance.
Claim 13
Dependent Claim 36 words
The dilatation catheter of claim 8, wherein at diameters less than a predetermined maximum diameter of the limited compliance dilatation balloon, the diameter of the limited compliance dilatation balloon is a linear function of inflation pressure.
Claim 14
Dependent Claim 52 words
The dilatation catheter of claim 11 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the limited compliance dilatation balloon.
Claim 15
Dependent Claim 43 words
The dilatation catheter of claim 12 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.
Claim 16
Dependent Claim 17 words
The dilatation catheter of claim 13, wherein the at least one helical groove includes multiple helical grooves.
Claim 17
Dependent Claim 35 words
The dilatation catheter of claim 14 wherein the helical grooves are constructed such that increasing their number increases the diametrical compliance of the balloon and decreasing their number decreases the diametrical compliance of the balloon.
Claim 18
Dependent Claim 20 words
The dilatation catheter of claim 13, wherein the multiple helical grooves extend parallel to each other in the dilating surface.
Claim 19
Dependent Claim 21 words
The dilatation catheter of claim 13, wherein the multiple helical grooves are not parallel to each other in the dilating surface.
Claim 20
Dependent Claim 19 words
The dilatation catheter of any one of claims 8-17 wherein the balloon is constructed of a substantially non-compliant material.
Claim 21
Dependent Claim 12 words
The dilatation catheter of claim 18, wherein the material is polyethylene terephthalate.
Claim 22
Dependent Claim 39 words
The dilatation catheter of either one of claims 8 or 5 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating surface of the limited compliance dilatation balloon.
Claim 23
Dependent Claim 76 words
A limited compliance dilatation catheter balloon having a dilating surface, comprising: at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the pitch, width and depth of the at least one helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to compliantly control the effective dilating diameter of the balloon.
Claim 24
Dependent Claim 76 words
A limited compliance dilatation catheter balloon having a dilating surface, comprising: at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the pitch, width and depth of the at least one helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to compliantly control the effective dilating diameter of the balloon.
Claim 25
Dependent Claim 43 words
The limited compliance dilatation catheter balloon of claim 21, wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.
Claim 26
Dependent Claim 42 words
The limited compliance dilatation catheter balloon of claim 22 wherein the at least one helical groove is disposed in each of a plurality of selected portions of the dilating surface of the balloon to provide a plurality of zones of diametrical compliance.
Claim 27
Dependent Claim 41 words
The limited compliance dilatation catheter balloon of claim 21, wherein at diameters less than a predetermined maximum diameter of the limited compliance dilatation catheter balloon, the diameter of the limited compliance dilatation catheter balloon is a linear function of inflation pressure.
Claim 28
Dependent Claim 52 words
The limited compliance dilatation catheter balloon of claim 24 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.
Claim 29
Dependent Claim 46 words
The limited compliance dilatation catheter balloon of claim 25 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.
Claim 30
Dependent Claim 16 words
The limited compliance dilatation catheter balloon of claim 26 wherein the balloon includes multiple helical grooves.
Claim 31
Dependent Claim 38 words
The limited compliance dilatation catheter balloon of claim 27 wherein the helical grooves are constructed such that increasing their number increases the diametrical compliance of the balloon and decreasing their number decreases the diametrical compliance of the balloon.
Claim 32
Dependent Claim 23 words
The limited compliance dilatation catheter balloon of claim 27, wherein the multiple helical grooves extend parallel to each other in the dilating surface.
Claim 33
Dependent Claim 24 words
The limited compliance dilatation catheter balloon of claim 27, wherein the multiple helical grooves are not parallel to each other in the dilating surface.
Claim 34
Dependent Claim 20 words
The dilatation catheter balloon of any one of claims 21-30 wherein the balloon is constructed of a substantially non-compliant material.
Claim 35
Dependent Claim 15 words
The limited compliance dilatation catheter balloon of claim 31 wherein the material comprises polyethylene terephthalate.
Claim 36
Independent Claim 106 words
A method of dilating a blood vessel with a dilatation catheter comprising the steps of: positioning a dilatation catheter having a deflated limited compliance dilatation balloon adapted to dilate a lumen of a blood vessel when inflated, the balloon including at least one helical groove disposed in at least a portion of a dilating surface of the balloon, the groove being constructed to deflect and diminish in depth with increased inflation pressure to enable the diameter of the balloon to increase and enable the balloon to be substantially free of flat folds when deflated; and inflating the limited compliance dilatation balloon to dilate the blood vessel.
Claim 37
Independent Claim 106 words
A method of dilating a blood vessel with a dilatation catheter comprising the steps of: positioning a dilatation catheter having a deflated limited compliance dilatation balloon adapted to dilate a lumen of a blood vessel when inflated, the balloon including at least one helical groove disposed in at least a portion of a dilating surface of the balloon, the groove being constructed to deflect and diminish in depth with increased inflation pressure to enable the diameter of the balloon to increase and enable the balloon to be substantially free of flat folds when deflated; and inflating the limited compliance dilatation balloon to dilate the blood vessel.
Claim 38
Dependent Claim 28 words
The method of claim 33 further comprising a step of varying a diameter of the balloon by varying the pressure of an inflation fluid in the dilatation balloon.
Claim 39
Dependent Claim 29 words
The method of claim 34, wherein the diameter of the limited compliance dilatation balloon varies as a linear function of the pressure until a predetermined maximum diameter is reached.
Claim 40
Dependent Claim 15 words
The method of claim 35 wherein the balloon is constructed of a substantially non-compliant material.
Claim 41
Dependent Claim 34 words
The method of claim 33 wherein the blood vessel is curved and wherein the balloon, when inflated, conforms to the curvature of blood vessel and dilates the blood vessel without straightening the blood vessel.
Claim 42
Dependent Claim 118 words
A dilatation catheter comprising: a catheter shaft having a distal end; a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon having a dilating surface and being adapted to dilate the lumen of a blood vessel when inflated; the dilating surface of the balloon including at least one helical groove disposed in at least a portion of the dilating surface wherein the pitch and depth of the helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to control the effective dilating diameter of the balloon the balloon, when deflated, being substantially free of flat folds.
Claim 43
Dependent Claim 118 words
A dilatation catheter comprising: a catheter shaft having a distal end; a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon having a dilating surface and being adapted to dilate the lumen of a blood vessel when inflated; the dilating surface of the balloon including at least one helical groove disposed in at least a portion of the dilating surface wherein the pitch and depth of the helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to control the effective dilating diameter of the balloon the balloon, when deflated, being substantially free of flat folds.
Claim 44
Dependent Claim 40 words
The dilatation catheter of claim 38 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.
Claim 45
Dependent Claim 42 words
The dilatation catheter of claim 39 wherein the at least one helical groove is disposed in multiple selected separate portions of the dilating surface of the balloon to provide a respective zone of diametrical compliance in each of the selected separate portions.
Claim 46
Dependent Claim 30 words
The dilatation catheter of claim 38 wherein at diameters less than a predetermined maximum diameter of the balloon, the diameter of the balloon is a linear function of inflation pressure.
Claim 47
Dependent Claim 49 words
The dilatation catheter of claim 41 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.
Claim 48
Dependent Claim 43 words
The dilatation catheter of claim 42 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.
Claim 49
Dependent Claim 12 words
The dilatation catheter of claim 43 wherein there are multiple helical grooves.
Claim 50
Dependent Claim 34 words
The dilatation catheter of claim 43 wherein increasing the number of helical grooves increases the diametrical compliance of the balloon and decreasing the number of helical grooves decreases the diametrical compliance of the balloon.
Claim 51
Dependent Claim 20 words
The dilatation catheter of claim 44 wherein the multiple helical grooves extend parallel to each other in the dilating surface.
Claim 52
Dependent Claim 21 words
The dilatation catheter of claim 44 wherein the multiple helical grooves are not parallel to each other in the dilating surface.
Claim 53
Dependent Claim 24 words
The dilatation catheter of any one of claims 38-47 wherein the limited compliance dilatation balloon is constructed of a material that is substantially non-compliant.
Claim 54
Dependent Claim 12 words
The dilatation catheter of claim 48 wherein the material is polyethylene terephthalate.
Claim 55
Dependent Claim 84 words
A limited compliance dilatation catheter balloon adapted to dilate a blood vessel lumen when inflated and having a dilating surface, comprising: at least one helical groove disposed in at least a portion of the dilating surface of the balloon, the at least one helical groove having at least one of a pitch, width and depth selected to control the diametrical compliance of the balloon; the at least one groove enabling the balloon to be substantially free of flat folds when the balloon is deflated.
Claim 56
Dependent Claim 84 words
A limited compliance dilatation catheter balloon adapted to dilate a blood vessel lumen when inflated and having a dilating surface, comprising: at least one helical groove disposed in at least a portion of the dilating surface of the balloon, the at least one helical groove having at least one of a pitch, width and depth selected to control the diametrical compliance of the balloon; the at least one groove enabling the balloon to be substantially free of flat folds when the balloon is deflated.
Claim 57
Dependent Claim 36 words
The dilatation catheter of either one of claims 38 or 50 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating surface of the balloon.
Claim 58
Dependent Claim 43 words
The limited compliance dilatation catheter balloon of claim 50 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.
Claim 59
Dependent Claim 45 words
The limited compliance dilatation catheter balloon of claim 51 wherein the at least one helical groove is disposed in multiple selected separate portions of the dilating surface of the balloon to provide a respective zone of diametrical compliance in each of the selected separate portions.
Claim 60
Dependent Claim 33 words
The limited compliance dilatation catheter balloon of claim 50 wherein at diameters less than a predetermined maximum diameter of the balloon, the diameter of the balloon is a linear function of inflation pressure.
Claim 61
Dependent Claim 52 words
The limited compliance dilatation catheter balloon of claim 55 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.
Claim 62
Dependent Claim 46 words
The limited compliance dilatation catheter balloon of claim 55 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.
Claim 63
Dependent Claim 20 words
The limited compliance dilatation catheter balloon of claim 56, wherein the at least one helical groove includes multiple helical grooves.
Claim 64
Dependent Claim 38 words
The limited compliance dilatation catheter balloon of claim 57 wherein increasing the number of helical grooves increases the diametrical compliance of the balloon and decreasing the number of the helical grooves decreases the diametrical compliance of the balloon.
Claim 65
Dependent Claim 23 words
The limited compliance dilatation catheter balloon of claim 57, wherein the multiple helical grooves extend parallel to each other in the dilating surface.
Claim 66
Dependent Claim 24 words
The limited compliance dilatation catheter balloon of claim 57, wherein the multiple helical grooves are not parallel to each other in the dilating surface.
Claim 67
Dependent Claim 20 words
The dilatation catheter balloon of any one of claims 50-60 wherein the balloon is constructed of a substantially non-compliant material.
Claim 68
Dependent Claim 15 words
The limited compliance dilatation catheter balloon of claim 61, wherein the material in polyethylene terephthalate.
Claim 69
Dependent Claim 21 words
A method of dilating a blood vessel as defined in claim 1 wherein the balloon includes only a single helical groove.
Claim 70
Dependent Claim 17 words
A dilatation catheter as defined in claim 8 wherein the balloon includes only a single helical groove.
Claim 71
Dependent Claim 20 words
A limited compliance dilatation catheter balloon as defined in claim 21 wherein the balloon includes only a single helical groove.
Claim 72
Dependent Claim 25 words
A method of dilating a blood vessel with a dilatation catheter as defined in claim 33 wherein the balloon has only a single helical groove.
Claim 73
Dependent Claim 17 words
A dilatation catheter as defined in claim 38 wherein the balloon has only a single helical groove.
Claim 74
Dependent Claim 20 words
A limited compliance dilatation catheter balloon as defined in claim 50 wherein the balloon includes only a single helical groove.
Claim 75
Dependent Claim 41 words
A method dilating blood vessel with the dilatation catheter is defined in claim 1 wherein at least one of the pitch, width and depth of the least one helical groove varies over the dilating surface of the limited compliance dilatation balloon.
Claim 76
Dependent Claim 40 words
A method of dilating a blood vessel with dilatation catheter is defined in claim 33 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating service of the balloon.

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