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US5540707A Expired / Lapsed US ⏱️ 0.0 years remaining

Expandable intravascular occlusion material removal devices and methods of use

Assignee: Boston Scientific Scimed Inc
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Filing: 1994-06-17
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Granted: 1996-07-30
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Expires: 2014-06-17
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Abstract

Abstract An improved expandable removal element for an atherectomy device wherein the expandable removal element is movable between an expanded position and a contracted position. In one embodiment of the present invention, a single drive shaft is operatively connected to the distal end of the expandable material removal element for rotating the removal element. A catheter surrounds a portion of the drive shaft. The catheter is shiftable with respect to the drive shaft for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft and the outer drive are shiftable with respect to one another for moving the removal element between the expanded position and the contracted position. The present invention also describes several embodiments for an improved removal element. One embodiment or the present invention is to provide a braid pattern wherein each single primary braid wire within the braid pattern is individually radially wrapped with a second "wrapping" wire. The "wrapping" wire, which is coated with an abrasive, primarily performs the removal function. Finally, a number of novel methods for removing vascular occlusion material are provided.

Inventors

  • 👤 Thomas V. Ressemann
  • 👤 Anthony C. Vrba
  • 👤 Steven S. Hackett
  • 👤 Chad J. Kugler

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 17:55
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/3205; A61B17/3207; A61B17/320725; A61B17/22; A61B2017/22038; A61B2017/22042; A61B2017/22072; A61B2017/22074; A61B2017/22075; A61B2017/320004; A61B2017/320012; A61B90/00; A61B90/39

Claims Analysis

Total Claims: 56
Claim 1
Independent Claim 117 words
An intravascular device for removing vascular occlusion material within a vascular lumen in a patient, the intravascular device comprising: an expandable removal element having a proximal and a distal end wherein the removal element including a plurality of strands that are braided together to form the removal element wherein each one of said plurality of strands is wrapped with at least one wrapping wire; an inner drive shaft including a helix extending through the removal element and operatively connected to the distal end of the removal element for energizing the removal element intravascularly; and an outer drive shaft comprising a helix operatively coupled to the proximal end of the removal element for energizing the removal element intravascularly.
Claim 2
Dependent Claim 117 words
An intravascular device for removing vascular occlusion material within a vascular lumen in a patient, the intravascular device comprising: an expandable removal element having a proximal and a distal end wherein the removal element including a plurality of strands that are braided together to form the removal element wherein each one of said plurality of strands is wrapped with at least one wrapping wire; an inner drive shaft including a helix extending through the removal element and operatively connected to the distal end of the removal element for energizing the removal element intravascularly; and an outer drive shaft comprising a helix operatively coupled to the proximal end of the removal element for energizing the removal element intravascularly.
Claim 3
Dependent Claim 32 words
An intravascular device as defined in claim 1 further comprising: rotating means operatively connected to the removal element by the inner and the outer drive shafts for rotating the removal element intravascularly.
Claim 4
Dependent Claim 15 words
An intravascular device as defined in claim 2 wherein said rotating means includes a motor.
Claim 5
Dependent Claim 86 words
An intravascular device as defined in claim 3 further comprising an electric motor control circuit wherein the electric motor control circuit includes; limiting means coupled to the motor and to a battery power supply for limiting the amount of torque the motor can deliver to the inner and outer drive shafts and to the removal element; voltage regulation means; and indicating means coupled to the limiting means for indicating to the attending physician how much torque is being supplied by the motor at any given time.
Claim 6
Dependent Claim 36 words
An electric motor control circuit as defined in claim 4 wherein said indicating means further provides for a warning tone when the torque supplied by the motor is approaching a torque limit of said limiting means.
Claim 7
Dependent Claim 41 words
An intravascular device as defined in claim 1 further comprising a distal tip located at the distal end of said removal element wherein an abrasive is deposited on the distal tip to create a cutting surface distally of the removal element.
Claim 8
Dependent Claim 23 words
An intravascular device as defined in claim 1 wherein said inner drive shaft includes an inner and an outer coaxial oppositely wound helices.
Claim 9
Dependent Claim 23 words
An intravascular device as defined in claim 7 further comprising a ribbon operatively connected to the inner helix of the inner drive shaft.
Claim 10
Dependent Claim 21 words
An intravascular device as defined in claim 1 wherein each one of said plurality of strands comprises at least one wire.
Claim 11
Dependent Claim 24 words
An intravascular device as defined in claim 1 wherein at least one of the wires in the plurality of strands are made from nitinol.
Claim 12
Dependent Claim 17 words
An intravascular device as defined in claim 9 wherein said wrapping wire is made of stainless steel.
Claim 13
Dependent Claim 17 words
An intravascular device as defined in claim 11 wherein an abrasive is deposited on said wrapping wire.
Claim 14
Dependent Claim 28 words
An intravascular device as defined in claim 12 wherein said abrasive comprises at least one of a diamond grit and a synthetic abrasive disposed onto the wrapping wires.
Claim 15
Dependent Claim 55 words
An intravascular device as defined in claim 1 wherein said outer drive shaft includes an inner and an outer coaxial oppositely wound helices wherein the outer helix is wound in the opposite direction of the inner drive shafts rotation direction and the inner helix is wound in the direction of the inner drive shafts rotation.
Claim 16
Dependent Claim 23 words
An intravascular device as defined in claim 14 further comprising a ribbon helix wrapped around the inner helix of the outer drive shaft.
Claim 17
Dependent Claim 34 words
An intravascular device as defined in claim 1 wherein the winding angle of the helix of the outer drive shaft is less than the winding angle of the helix of the inner drive shaft.
Claim 18
Dependent Claim 29 words
An intravascular device as defined in claim 1 wherein the inner drive shaft and the outer drive shaft are lubricated with a liquid solution that is located there between.
Claim 19
Dependent Claim 19 words
An intravascular device as defined in claim 1 wherein the inner drive shaft is coated with a lubricous material.
Claim 20
Dependent Claim 19 words
An intravascular device as defined in claim 1 wherein the outer drive shaft is coated with a lubricous material.
Claim 21
Dependent Claim 27 words
An intravascular device as defined in claim 1 further comprising a removable guide wire passable through the inner drive shaft and extendable distally of the removal element.
Claim 22
Dependent Claim 18 words
An intravascular device as defined in claim 20 wherein said guide wire comprises a 1-3 cm coiled tip.
Claim 23
Dependent Claim 23 words
An intravascular device as defined in claim 1 wherein a substantial length of the outer drive shaft is enclosed within an outer sheath.
Claim 24
Dependent Claim 57 words
An intravascular device as defined in claim 22 wherein said outer sheath comprises; an inner sheath layer constructed from a lubricous material; and an outer sheath layer constructed from a flexible material wherein said outer sheath layer coaxially receives said inner sheath layer and wherein said outer sheath layer and said inner sheath layer are connected together.
Claim 25
Dependent Claim 28 words
An intravascular device as defined in claim 1 further comprising an actuation mechanism for controlling movement of the removal element between an expanded position and a contracted position.
Claim 26
Dependent Claim 26 words
An intravascular device as defined in claim 24 wherein said actuation mechanism controls a slidable movement between the inner drive shaft and the outer drive shaft.
Claim 27
Dependent Claim 24 words
An intravascular device as defined in claim 24 further comprising a sliding mechanism for positively controlling proximal and distal movement of the removal element.
Claim 28
Dependent Claim 33 words
An intravascular device as defined in claim 26 wherein said sliding mechanism allows a conjoint slidable movement of the inner drive shaft and the outer drive shaft with respect to a drive housing.
Claim 29
Dependent Claim 38 words
A intravascular device as defined in claim 24 wherein the actuation mechanism includes an actuation portion for accepting force from a treating physician to control movement of the removal element between the expanded position and the contracted position.
Claim 30
Dependent Claim 37 words
A intravascular device as defined in claim 28 further comprising a scaling means operatively associated with the actuation mechanism for providing an indication of position of the removal element between the expanded position and the contracted position.
Claim 31
Dependent Claim 20 words
An intravascular device as defined in claim 1 further comprising means for limiting expansion of the expandable material removal element.
Claim 32
Dependent Claim 46 words
A removal element for an intravascular device for removing vascular occlusion material within a vascular lumen in a patient comprising: a plurality of strands that are braided together wherein at least one of said plurality of strands is wrapped circumferentially with at least on wrapping wire.
Claim 33
Dependent Claim 46 words
A removal element for an intravascular device for removing vascular occlusion material within a vascular lumen in a patient comprising: a plurality of strands that are braided together wherein at least one of said plurality of strands is wrapped circumferentially with at least on wrapping wire.
Claim 34
Dependent Claim 21 words
A removal element as defined in claim 31 wherein said plurality of strands are braided together using a 1-over/1-under braid pattern.
Claim 35
Dependent Claim 27 words
A removal element as defined in claim 31 wherein at least one of the wires used in the plurality of strands are made from a radiopaque material.
Claim 36
Dependent Claim 24 words
A removal element as defined in claim 31 wherein at least one of the wires in the plurality of strands are made from nitinol.
Claim 37
Dependent Claim 17 words
A removal element as defined in claim 31 wherein said wrapping wire is made of stainless steel.
Claim 38
Dependent Claim 17 words
A removal element as defined in claim 31 wherein an abrasive is deposited on said wrapping wire.
Claim 39
Dependent Claim 27 words
A removal element as defined in claim 36 wherein said abrasive comprises at least one of a diamond grit and a synthetic abrasive disposed onto the wires.
Claim 40
Dependent Claim 14 words
A removal element as defined in claim 31 wherein the wrapping wire is radiopaque.
Claim 41
Dependent Claim 21 words
A removal element as defined in claim 31 wherein said plurality of strands are braided together using a 2-over/2-under braid pattern.
Claim 42
Dependent Claim 21 words
A removal element as defined in claim 31 wherein each one of said plurality of strands comprises at least one wire.
Claim 43
Dependent Claim 45 words
A shaft used in an intravascular device comprising a prestressed wire formed into a helix, the wire having a diameter, a length and a longitudinal axis parallel the length, the wire being prestressed about the axis of the wire to give the helix increased strength.
Claim 44
Dependent Claim 45 words
A shaft used in an intravascular device comprising a prestressed wire formed into a helix, the wire having a diameter, a length and a longitudinal axis parallel the length, the wire being prestressed about the axis of the wire to give the helix increased strength.
Claim 45
Dependent Claim 34 words
A drive shaft used to drive a removal element in an intravascular device as defined in claim 41 further comprising a ribbon wire operatively connected to said helix of wire for providing longitudinal support.
Claim 46
Dependent Claim 129 words
A drive shaft used to drive a removal element in an intravascular device for removing vascular occlusion material within a vascular lumen in a patient comprising: an inner helix of wire having a diameter and a length wherein the inner helix is wound in a direction of rotation of the drive shaft; and an outer helix of wire receiving the inner helix of wire in a coaxial manner wherein the outer helix is wound in an opposite direction from the direction of rotation of the drive shaft; whereby the inner helix exerts an outward force against the outer helix and the outer helix exerts an inward force against the inner helix when a rotational force in the direction of rotation is applied to an end of the drive shaft.
Claim 47
Dependent Claim 129 words
A drive shaft used to drive a removal element in an intravascular device for removing vascular occlusion material within a vascular lumen in a patient comprising: an inner helix of wire having a diameter and a length wherein the inner helix is wound in a direction of rotation of the drive shaft; and an outer helix of wire receiving the inner helix of wire in a coaxial manner wherein the outer helix is wound in an opposite direction from the direction of rotation of the drive shaft; whereby the inner helix exerts an outward force against the outer helix and the outer helix exerts an inward force against the inner helix when a rotational force in the direction of rotation is applied to an end of the drive shaft.
Claim 48
Independent Claim 163 words
A method for removing occlusion material from a vascular lumen within a patient comprising the steps of: providing an occlusion material removal device having an expandable removal element and two coaxial drive shafts, the two coaxial drive shafts comprising an inner rotatable drive shaft and an outer rotatable drive shaft wherein the inner rotatable drive shaft is operatively coupled to a distal end of the removal element and the outer rotatable drive shaft is operatively coupled to the proximal end of the removal element and wherein the two drive shafts are shiftable with respect to one another for moving the material removal element between the expanded position and the contracted position; navigating the removal element to the occlusion material; shifting the drive shafts with respect to one another causing the removal element to expand intravascularly; and moving the inner drive shaft and the outer drive shaft conjointly and with respect to the drive assembly to force the removal element into the occlusion material.
Claim 49
Independent Claim 163 words
A method for removing occlusion material from a vascular lumen within a patient comprising the steps of: providing an occlusion material removal device having an expandable removal element and two coaxial drive shafts, the two coaxial drive shafts comprising an inner rotatable drive shaft and an outer rotatable drive shaft wherein the inner rotatable drive shaft is operatively coupled to a distal end of the removal element and the outer rotatable drive shaft is operatively coupled to the proximal end of the removal element and wherein the two drive shafts are shiftable with respect to one another for moving the material removal element between the expanded position and the contracted position; navigating the removal element to the occlusion material; shifting the drive shafts with respect to one another causing the removal element to expand intravascularly; and moving the inner drive shaft and the outer drive shaft conjointly and with respect to the drive assembly to force the removal element into the occlusion material.
Claim 50
Dependent Claim 47 words
A method as defined in claim 44 wherein the moving step comprises moving the inner drive shaft and the outer drive shaft conjointly and with respect to the drive assembly such that the expanded removal element moves distally within the vascular lumen to engage the occlusion material.
Claim 51
Dependent Claim 47 words
A method as defined in claim 44 wherein the moving step comprises moving the inner drive shaft and the outer drive shaft conjointly and with respect to the drive assembly such that the expanded removal element moves proximally within the vascular lumen to engage the occlusion material.
Claim 52
Dependent Claim 25 words
A method as defined in claim 44 wherein the navigating step comprises positioning the removal element in a contracted position distally of the occlusion material.
Claim 53
Dependent Claim 40 words
A method as defined in claim 44 wherein the providing step includes providing a collection portion on the material removal element for collecting removed occlusion material, and further comprising the step of collecting removed occlusion material in the collection portion.
Claim 54
Dependent Claim 41 words
A method as defined in claim 44 wherein the providing step includes shifting the inner rotatable drive shaft proximally with respect to the outer rotatable drive shaft for moving the material removal element between the expanded position and the contracted position.
Claim 55
Dependent Claim 41 words
A method as defined in claim 44 wherein the providing step includes shifting the outer rotatable drive shaft distally with respect to the inner rotatable drive shaft for moving the material removal element between the expanded position and the contracted position.
Claim 56
Dependent Claim 69 words
A method according to claim 44 wherein the providing step further comprises providing a prime mover operatively connected to the removal element by the inner rotatable drive shaft and the outer rotatable drive shaft for rotating the element intravascularly, and further comprising the steps of: rotating the expanded removal element to generate occlusion material removing force; and concentrating the removing force on the occlusion material to remove the material.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1999-07-30 2000-01-29 2000-07-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2003-07-30 2004-01-29 2004-07-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2007-07-30 2008-01-29 2008-07-30 $7700.00 Window Closed / Lapsed

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