US20170303944A1 - Vascular and bodily duct treatment devices and methods - Google Patents

Abstract

Devices including, but not limited to, a self-expandable member having a proximal end portion and a main body portion. The self-expandable member is movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a vessel or duct of a patient. The expandable member includes a plurality of cell structures with the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member and the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member.

Description

RELATED APPLICATION
• This application claims the benefit to and is a continuation of U.S. patent application Ser. No. 13/365,884, filed Feb. 3, 2012, which is a continuation-in-part of U.S. patent application Ser. No. 13/303,890, filed Nov. 23, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 13/021,364, filed Feb. 4, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 12/832,857, filed Jul. 8, 2010, which is a a continuation-in-part of U.S. patent application Ser. No. 12/643,942, filed Dec. 21, 2009, which is a continuation-in-part of U.S. patent application Ser. No. 12/573,676, filed Oct. 5, 2009, which is a continuation-in-part of U.S. patent application Ser. No. 12/499,713, filed Jul. 8, 2009, the disclosures of all of which being incorporated herein by reference in their entireties as if fully set forth here.
TECHNICAL FIELD
• This application relates to devices and methods for treating the vasculature and other ducts within the body.
BACKGROUND
• Self-expanding prostheses, such as stents, covered stents, vascular grafts, flow diverters, and the like have been developed to treat ducts within the body. Many of the prostheses have been developed to treat blockages within the vasculature and also aneurysms that occur in the brain. What are needed are improved treatment methods and devices for treating the vasculature and other body ducts, such as, for example, aneurysms, stenoses, embolic obstructions, and the like.
SUMMARY OF THE DISCLOSURE
• In accordance with one implementation a vascular or bodily duct treatment device is provided that comprises an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within the bodily duct or vasculature of a patient, the expandable member comprising a plurality of cell structures, the expandable member having a proximal end portion with a proximal end, a cylindrical main body portion and a distal end portion with a distal end, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a distal position at or near the cylindrical main body portion. In one implementation the self-expandable member has a longitudinal slit extending along at least a portion of the length of the self-expandable member between the proximal end and the distal end.
• In accordance with another implementation a kit is provided that comprises an elongate flexible wire having a proximal end and a distal end with an elongate self-expandable member coupled to the distal end, the self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment in the bodily duct or vasculature of a patient, the self-expandable member comprising a plurality of cell structures, the self-expandable member having a proximal end portion with a proximal end, a cylindrical main body portion and a distal end portion with a distal end, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a distal position at or near the cylindrical main body portion, the elongate wire with the expandable member having a first length; and a delivery catheter having a second length and sufficient flexibility to navigate the vasculature or bodily duct of the patient, the delivery catheter having a proximal end, a distal end and an inner lumen, the inner lumen having a diameter sufficient to receive the self-expandable member in its unexpanded position and for advancing the unexpanded member from the proximal end to the distal end of the catheter, the second length being less than the first length to allow distal advancement of the self-expandable member beyond the distal end of the catheter to permit the expandable member to deploy toward its expanded position, the distal end of the catheter and the self-expandable member configured to permit proximal retraction of the self-expandable member into the lumen of the catheter when the self-expandable member is partially or fully deployed outside the distal end of the catheter. In one implementation, the self-expandable member has a longitudinal slit extending along at least a portion of the length of the self-expandable member between the proximal end and the distal end.
• In accordance with one implementation, a bodily duct or vascular treatment device is provided having an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within the bodily duct or vasculature of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion. In one implementation, connected to the proximal-most end of the expandable member is a proximally extending elongate flexible wire having a length and flexibility sufficient for navigating and accessing the vasculature or bodily duct of the patient.
• In accordance with another implementation, a vascular treatment device is provided that includes an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within the vasculature of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of cell structures that are arranged to induce twisting of the expandable member as the expandable member transitions from the unexpanded position to the expanded position, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion. In one implementation, connected to the proximal-most end of the expandable member is a proximally extending elongate flexible wire having a length and flexibility sufficient for navigating and accessing the vasculature or bodily duct of the patient.
• In accordance with another implementation, a bodily duct or vascular treatment device is provided that includes an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within the bodily duct or vasculature of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected to form a plurality of diagonally disposed cell structures, the expandable member having a cylindrical portion and a distal end portion, the cell structures in the cylindrical portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the distal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the proximal-most cell structures in the main body portion having proximal-most end points. One or more of the proximal-most end points of the expandable member have a proximally extending elongate flexible wire having a length and flexibility sufficient for navigating and accessing the vasculature or bodily duct of the patient.
• In accordance with another implementation, a kit is provided that includes an elongate flexible wire having a proximal end and a distal end with an elongate self-expandable member attached to the distal end, the self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a bodily duct or vasculature of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion, the elongate wire and expandable member having a first length, and a delivery catheter having a second length and sufficient flexibility to navigate the vasculature or bodily duct of a patient, the delivery catheter having a proximal end, a distal end and an inner diameter, the inner diameter sufficient to receive the expandable member in its unexpanded position and for advancing the unexpanded member from the proximal end to the distal end of the catheter, the second length being less that the first length to allow distal advancement of the expandable member beyond the distal end of the catheter to permit the expandable member to deploy toward its expanded position, the distal end of the catheter and the expandable member configured to permit proximal retraction of the expandable member into the catheter when the expandable member is partially or fully deployed outside the distal end of the catheter.
• In accordance with another implementation, a method for removing an embolic obstruction from a vessel of a patient is provided that includes (a) advancing a delivery catheter having an inner lumen with proximal end and a distal end to the site of an embolic obstruction in the intracranial vasculature of a patient so that the distal end of the inner lumen is positioned distal to the embolic obstruction, the inner lumen having a first length, (b) introducing an embolic obstruction retrieval device comprising an elongate flexible wire having a proximal end and a distal end with an elongate self-expandable member attached to the distal end into the proximal end of the inner lumen of the catheter and advancing the self-expandable member to the distal end of the lumen, the self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer cell structures in the proximal end portion having proximal linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal end of the expandable member to a position at or near the cylindrical main body portion, the elongate wire and expandable member in combination having a second length longer than the first length, (c) proximally retracting the delivery catheter sufficient to deploy the self-expandable device so that the one or more of the cell structures entrap at least a portion of the embolic obstruction, and (d) proximally retracting the delivery catheter and self-expandable device to outside the patient. In an alternative implementation, the self-expandable member is partially or fully retracted into the inner lumen of the delivery catheter prior to proximally retracting the delivery catheter and self-expandable device to outside the patient.
• In accordance with another implementation, a device is provided comprising an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a vessel or duct of a patient, the expandable member comprising a plurality of cell structures, the expandable member having a proximal end portion with a proximal end and a cylindrical main body portion, the cell structures in the main body portion comprise a first plurality of intersecting struts and extend circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion comprise a second plurality of intersecting struts and extend less than circumferentially around the longitudinal axis of the expandable member, at least some of the first plurality of intersecting struts having a thickness to width ratio of greater than one.
• In accordance with yet another implementation, a device is provided comprising a delivery wire, an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a vessel or duct of a patient, the expandable member comprising a plurality of cell structures, the expandable member having a proximal end portion with a proximal end and a cylindrical main body portion, the proximal end having an integrally formed wire segment extending therefrom with a coil positioned about the wire segment, the coil comprising a first closely wound segment and a second loosely wound segment that contains at least one gap, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, a proximal end of the wire segment attached to a distal end of the delivery wire by a bonding agent within the second loosely wound segment of the coil.
• In accordance with yet another implementation, a device is provided comprising an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a vessel or duct of a patient, the expandable member comprising a plurality of cell structures, the expandable member having a proximal end portion with a proximal end and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures having dimensional and material characteristics that result in about a −1.5N to a about a −3.5N overall reduction in radial force along the length of the expandable member per millimeter of expansion during about an initial 0.50 mm diametric range of expansion from the nominal diameter and that results in about a −0.10N to about a −0.50N overall reduction in radial force along the length of the expandable member per millimeter of expansion during subsequent diametric ranges of expansion. In one implementation the elongate self-expandable member has a designated maximum second nominal diameter, the radial force exerted by the elongate self-expandable member being greater than zero when expanded to the maximum second nominal diameter.
• In accordance with yet another implementation, a device is provided comprising an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within the bodily duct or vasculature of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures having dimensional and material characteristics that result in about a −1.5N to a about a −3.5N overall reduction in radial force along the length of the expandable member per millimeter of expansion during about an initial 0.50 mm diametric range of expansion from the first nominal diameter and that results in about a −0.10N to about a −0.50N overall reduction in radial force along the length of the expandable member per millimeter of expansion during subsequent diametric ranges of expansion. In one implementation the elongate self-expandable member has a designated maximum second nominal diameter, the radial force exerted by the elongate self-expandable member being greater than zero when expanded to the maximum second nominal diameter.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member to form first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension. In one implementation the first and second peripheral rails are devoid of undulations and the percentage change between the first width dimension and second width dimension is between about 20.0% and about 50.0%.
• In another implementations a clot retrieval devices is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member to form first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the percentage change between the first width dimension and second width dimension is between about 20.0% and about 50.0%, the third set of cell structures comprising struts having a third width dimensions less than the second width dimension, the fourth set of cell structures comprising struts having a fourth width dimensions less than the second width dimension, the percentage difference between the second width dimension and the third width dimension being between about 10.0% and about 25.0%, the percentage difference between the second width dimension and the fourth width dimension being between about 10.0% and about 25.0%.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member to form first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the percentage change between the first width dimension and second width dimension is between about 20.0% and about 50.0%, the third set of cell structures comprising struts having a third width dimension less than the second width dimension, the fourth set of cell structures comprising struts having a fourth width dimension substantially the same as the second width dimension, the percentage difference between the second width dimension and the third width dimension being between about 10.0% and about 25.0%.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member to form first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth and fifth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the size of the cell structures in the third and fifth set of cell structures being substantially the same, the size of the cell structures in the fourth set of cell structures being greater than the size of the cell structures in the third set of cell structures, the cell structures in the third, fourth and fifth set of cell structures comprising third, fourth and fifth struts, respectively, at least some of the fourth and fifth struts, or segments thereof, having a width dimension that is greater than the width dimension of the third struts.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member to form first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth and fifth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the size of the cell structures in the third and fifth set of cell structures being substantially the same, the size of the cell structures in the fourth set of cell structures being greater than the size of the cell structures in the third set of cell structures, the cell structures in the third, fourth and fifth set of cell structures comprising third, fourth and fifth struts, respectively, the width dimension of the third struts being less than the second width dimension, at least some of the fourth and fifth struts, or segments thereof, having a width dimension substantially equal to the second width dimension.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the proximal end portion forming first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth set of cell structures, the cell structures in the distal end portion comprising a sixth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension. In one implementation the first and second peripheral rails are devoid of undulations and the percentage change between the first width dimension and second width dimension is between about 20.0% and about 50.0%.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the proximal end portion forming first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth and fifth set of cell structures, the cell structures in the distal end portion comprising a sixth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the size of the cell structures in the third, fifth and sixth set of cell structures being substantially the same, the size of the cell structures in the fourth set of cell structures being greater than the size of the cell structures in the third, fifth and sixth set of cell structures, the cell structures in the third, fourth, fifth and sixth set of cell structures comprising third, fourth, fifth and sixth struts, respectively, at least some of the fourth and fifth struts, or segments thereof, having a width dimension that is greater than the width dimension of the third and sixth struts.
• In another implementation a clot retrieval device is provided comprising: an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal end portion, a cylindrical main body portion and a distal end portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the proximal end portion forming first and second peripheral rails having proximal and distal end segments, the cell structures in the proximal end portion comprising a first set of cell structures arranged to form the first peripheral rail, a second set of cell structures arranged to form the second peripheral rail and a third set of cell structures located between the first and second set of cell structures, the first and second set of cell structures having in common a proximal-most cell structure, the cell structures in the main body portion comprising a fourth and fifth set of cell structures, the cell structures in the distal end portion comprising a sixth set of cell structures, the proximal-most cell structure and the first set of cell structures having circumferential outer-most strut members that define the first peripheral rail, the proximal-most cell structure and the second set of cell structures having circumferential outer-most strut members that define the second peripheral rail, at least some of the circumferential outer-most strut members having different width dimensions and arranged so that the first and second peripheral rails vary between a first width dimension at the proximal end segment to second width dimension at the distal end segment, the second width dimension less than the first width dimension, the size of the cell structures in the third, fifth and sixth set of cell structures being substantially the same, the size of the cell structures in the fourth set of cell structures being greater than the size of the cell structures in the third, fifth and sixth set of cell structures, the cell structures in the third, fourth, fifth and sixth set of cell structures comprising third, fourth, fifth and sixth struts, respectively, the width dimension of the third and sixth struts being less than the second width dimension, at least some of the fourth and fifth struts, or segments thereof, having a width dimension substantially equal to the second width dimension.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most wall segments that form first and second rail segments that each extend from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion, the proximal-most cell structure of the proximal end portion comprising first and second outer struts that extend distally from the proximal antenna, in a two-dimensional layout at least a portion of each of the first and second outer struts comprise a straight segment, each of the straight segment being coextensive to the proximal antenna.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within an embolic obstruction of a patient, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, a first set of outer-most cell structures in the proximal end portion having proximal-most wall segments that form a non-undulating rail segment that extends from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion, and a second set of outer-most cell structures in the proximal end portion having proximal-most wall segments that form an undulating rail segment that extends from a position at or near the proximal-most end of the expandable member to a position at or near the cylindrical main body portion.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member having a radially expanded configuration and a radially unexpanded configuration, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion comprising a proximal section and a distal section, the cell structures in the cylindrical main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, in the expanded configuration the distal section of the cylindrical main body portion having an average diameter greater than the average diameter of the proximal section of the cylindrical main body portion. In some implementations the average length of the cell structures in the distal section of the cylindrical main body portion is greater than the average length of the cell structures in the proximal section of the cylindrical main body portion, the average length of the cell structures in the proximal section of the cylindrical main body portion being greater than the average length of the cell structures in the proximal end portion, the average length to width ratio of the cell structures in the proximal end portion and cylindrical main body portion being greater than one when the self-expandable member is in the constrained and unconstrained configuration.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member having a radially expanded configuration and a radially unexpanded configuration, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion comprising a proximal section and a distal section, the cell structures in the cylindrical main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the average length to width ratio of the cell structures in the distal section of the cylindrical main body portion being greater than the average length to width ratio of the cell structures in the proximal section of the cylindrical main body portion, the average length to width ratio of the cell structures in the proximal section of the cylindrical main body portion being greater than the average length to width ratio of the cell structures in the proximal end portion, the average length to width ratio of the cell structures in the proximal end portion being greater than one when the self-expandable member is in the unexpanded and expanded configuration.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member having a radially expanded configuration and a radially unexpanded configuration, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion, the cell structures in the cylindrical main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the cylindrical main body portion comprising proximal and distal facing V-like structures that are interconnected by a pair of diagonally extending and circumferentially spaced-apart struts, the proximal and distal V-like structures having a first average width dimension and the pair of diagonally extending and circumferentially spaced-apart struts having a second average width dimension that is greater than the first average width dimension.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member having a radially expanded configuration and a radially unexpanded configuration, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion comprising a proximal section and a distal section, the cell structures in the cylindrical main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the cylindrical main body portion comprising proximal and distal facing V-like structures that are interconnected by a pair of diagonally extending and circumferentially spaced-apart struts, the diagonally extending and circumferentially spaced-apart struts comprising first end segments, second end segments, and a middle segment disposed between the first and second end segments, the first end segments being coupled to the proximal V-like structure and the second end segments being coupled to the distal V-like structure, the proximal and distal V-like structures having a first average width dimension, the middle segments of the diagonally extending and circumferentially spaced-apart struts having a second average width dimension that is greater than the first average width dimension, the first and second end segments of the diagonally extending and circumferentially spaced-apart struts having a third average width dimension that is greater than the first average width dimension and less than the second average width dimension.
• In other implementations embolic obstruction retrieval devices are provided comprising; an elongate self-expandable member having a radially expanded configuration and a radially unexpanded configuration, the expandable member comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form a plurality of diagonally disposed cell structures, the expandable member having a proximal antenna, a proximal end portion and a cylindrical main body portion comprising a proximal section and a distal section, the cell structures in the cylindrical main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal end portion extending less than circumferentially around the longitudinal axis of the expandable member, the cell structures in the cylindrical main body portion comprising proximal and distal V-like structures that are interconnected by a pair of diagonally extending and circumferentially spaced-apart struts, at least some of the diagonally extending and circumferentially spaced-apart struts having one or more wires or ribbons wound thereabout so as to enhance the average deflection stiffness of all or a portion of the cylindrical main body portion when the self-expandable member is in the radially expanded configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• Alternative implementations of the present disclosure are described herein with reference to the drawings wherein:
• FIG. 1A illustrates a two-dimensional plane view of an expandable member of a treatment device in one embodiment.
• FIG. 1B is an isometric view of the expandable member illustrated inFIG. 1A
• FIG. 2 illustrates a distal wire segment that extends distally from an expandable member in one embodiment.
• FIG. 3 illustrates the distal end of an expandable member having an atraumatic tip.
• FIG. 4A illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 4B is an enlarged view of the proximal-most segment of the expandable member illustrated inFIG. 4A.
• FIG. 5 illustrates a distal end of an expandable member in one embodiment.
• FIG. 6A illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 6B is an isometric view of the expandable member illustrated inFIG. 6A.
• FIG. 7A illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 7B is an isometric view of the expandable member illustrated inFIG. 7A.
• FIG. 7C illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 8 illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 9 illustrates an expandable member in an expanded position having a bulge or increased diameter portion.
• FIG. 10 illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 11A illustrates a two-dimensional plane view of an expandable member of a treatment device in one implementation.
• FIG. 11B is an isometric view of the expandable member illustrated inFIG. 11A.
• FIG. 12 illustrates a two-dimensional plane view of an expandable member of a treatment device in another implementation.
• FIGS. 13A through 13C illustrate a method for retrieving an embolic obstruction in accordance with one implementation.
• FIG. 14 illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 15 illustrates a two-dimensional plane view of an expandable member of a treatment device in yet another embodiment.
• FIG. 16 illustrates an isometric view of an expandable member in another embodiment having an internal wire segment.
• FIG. 17 illustrates an isometric view of an expandable member in another embodiment having an external wire segment.
• FIG. 18 illustrates an isometric view of an expandable member in yet another embodiment having a distal emboli capture device.
• FIG. 19 illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 20 illustrates the expandable member ofFIG. 19 having a longitudinal slit.
• FIG. 21 illustrates the expandable member ofFIG. 19 having a spiral slit.
• FIG. 22 illustrates the expandable member ofFIG. 19 having a partial spiral slit.
• FIG. 23 illustrates a two-dimensional plane view of an expandable member of a treatment device in another embodiment.
• FIG. 24A illustrates a two-dimensional plane view of an expandable member of a treatment device in yet another embodiment.
• FIG. 24B is an isometric view of the expandable member illustrated inFIG. 24A.
• FIG. 25 illustrates a manner in which the proximal extending wire segment of an expandable device is attached to a delivery wire in one embodiment.
• FIG. 26 illustrates a two-dimensional plane view of an expandable member of a treatment device in yet another embodiment.
• FIGS. 27A and 27B illustrate isometric side and top views, respectively, of the expandable member depicted inFIG. 26.
• FIGS. 28A and 28B illustrate a proximal wire segment and a distal wire segment, respectively, of an expandable member in one implementation.
• FIG. 29 is a graph representing a radial force curve of an expandable member according to one implementation.
• FIG. 30 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 31 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIGS. 32A-C illustrate cell structures according to some of the implementations ofFIG. 31.
• FIG. 33A illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIGS. 33B and 33C illustrate top and side isometric views of the device illustrated inFIG. 33A.
• FIG. 34A illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIGS. 34B and 34C illustrate top and side isometric views of the device illustrated inFIG. 34A.
• FIG. 35A illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIGS. 35B and 35C illustrate top and side isometric views of the device illustrated inFIG. 35A.
• FIG. 36 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 37 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 38 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 39 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 40A illustrates a two-dimensional plane view of a clot retrieval device according to one implementation.
• FIG. 40B illustrates a three-dimensional view of the clot retrieval device ofFIG. 40A.
• FIG. 41 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 42A illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 42B illustrates an enlarged two-dimensional plane view of the proximal tapered end portion of the retriever device depicted inFIG. 45A.
• FIG. 43 illustrates a two-dimensional plane view of a proximal-most cell structure according some implementations.
• FIG. 44 illustrates a two-dimensional plane view of a proximal-most cell structure according some implementations.
• FIGS. 45A-C illustrate two-dimensional plane views of clot retrieval devices according some implementations.
• FIG. 46 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 47A illustrates a two-dimensional plane view of a distal end of clot retrieval devices according some implementations.
• FIG. 47B illustrates a three-dimensional view of the distal end depicted inFIG. 47A.
• FIG. 48A illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 48B illustrates a three-dimensional view of the clot retrieval device depicted inFIG. 48A.
• FIG. 49 illustrates a two-dimensional plane view of clot retrieval devices according some implementations.
• FIG. 50 illustrates a two-dimensional plane view of distal segment of a retrieval device according some implementations.
• FIGS. 51A-D illustrate two-dimensional plane views of retrieval devices according to some implementations.
• FIGS. 52A and 52B illustrate two-dimensional plane views of retrieval devices according to some implementations.
• FIG. 53 illustrates a two-dimensional plane view of a retrieval device according to some implementations.
• FIG. 54 illustrates a two-dimensional plane view of a retrieval device according to some implementations.
• FIG. 55 illustrates a two-dimensional plane view of a retrieval device according to some implementations.
• FIGS. 56A and 56B illustrates a two-dimensional plane view of retrieval devices according to some implementations.
• FIG. 57 illustrates a two-dimensional plane view of a retrieval device according to some implementations.
• FIG. 58A illustrates a two-dimensional plane view of a retrieval device according to some implementations.
• FIG. 58B illustrates an enlarged view of cell structures depicted inFIG. 58A.
• FIG. 59A illustrates a side view of a joint member according to one implementation.
• FIG. 59B illustrates a cross-sectional view of the joint member depicted inFIG. 59A.
• FIGS. 60A and 60B show wire attachment configurations according to some implementations.
DETAILED DESCRIPTION
• FIGS. 1A and 1B illustrate a vascular or bodilyduct treatment device10 in accordance with one embodiment of the present invention.Device10 is particularly suited for accessing and treating the intracranial vascular of a patient, such as for example treating aneurysms or capturing and removing embolic obstructions. It is appreciated however, thatdevice10 may be used for accessing and treating other locations within the vasculature and also other bodily ducts. Other uses include, for example, treating stenoses and other types of vascular diseases and abnormalities.FIG. 1A depictsdevice10 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 1B depicts the device in its manufactured and/or expanded tubular configuration.Device10 includes a self-expandable member12 that is attached or otherwise coupled to an elongateflexible wire40 that extends proximally from theexpandable member12. In one embodiment, theexpandable member12 is made of shape memory material, such as Nitinol, and is preferably laser cut from a tube. In one embodiment, theexpandable member12 has an integrally formed proximally extendingwire segment42 that is used to join the elongateflexible wire40 to theexpandable member12. In such an embodiment,flexible wire40 may be joined towire segment42 by the use of solder, a weld, an adhesive, or other known attachment method. In an alternative embodiment, the distal end offlexible wire40 is attached directly to aproximal end20 of theexpandable member12. In one embodiment, the distal end ofwire40 has a flat profile with a width of about 0.005 inches with the width and thickness of thewire segment42 being about 0.0063 and about 0.0035 inches, respectively.
• In one embodiment, the distal end ofwire40 is attached to the proximally extendingwire segment42 by the following method, resulting in the joint illustrated inFIG. 25. In one implementation, a coil41 is positioned overwire segment42, the coil having a closely wrappedsegment41aabutting the proximal end ofexpandable member12, and a loosely wrappedsegment41bthat includes one ormore gaps41c. The size of the one ormore gaps41cbeing sufficient to introduce a bonding agent into at least the inner cavity ofcoil segment41b. In one embodiment, the length ofwire segment42 and the coil41 are equal. In one embodiment the length of thewire segment42 is 4.0 millimeters with the coil41 being of equal length. Once the coil41 has been placed over thewire segment42, the distal end ofwire40 is placed withincoil segment41bso that it makes contact with and overlaps the proximal end portion ofwire segment42. A bonding agent is then applied through thegaps41cof coil41 to bond thewire40 with wire segment41. The bonding agent may be an adhesive, solder, or any other suitable bonding agent. When the bonding agent is a solder, a preceding step in the process involves coating the distal end portion ofwire40 and the proximal end portion ofwire segment42 with tin or another suitable wetting agent. In one implementation the solder is gold and is used to enhance the radiopacity of the joint so that the joint may serve as a proximal radiopaque marker. In addition to the use of gold, all or portions of the coil may be made of a radiopaque material to further enhance the radiopacity of the joint. According to one embodiment, the length of overlap between thewire40 andwire segment42 is between 0.75 and 1.0 millimeters. In the same implementation or in other implementations, the length ofcoil segment41bis equal, or substantially equal, to the overlap length of thewire40 andwire segment42. In an alternative embodiment, in lieu of the use of a single coil41, two or more coils in abutting relationship are used with, for example, a first closely wound coil abutting theproximal end20 of theexpandable member12 and a second loosely wound coil with gaps situated proximal to the closely wound coil. Although not shown in the figures, in one embodiment a distal end length ofwire40 is tapers in the distal direction from a nominal diameter to a reduced profile. Along this length is provided a distal wire coil of a constant outer diameter with no taper. In accordance with one implementation, the diameter of coil41 has the same outer diameter as the distal wire coil.
• One advantage of the joint construction is that it is resistant to buckling while the device is being pushed through a delivery catheter while at the same time being sufficiently flexible to enable the device to be delivered through the tortuous anatomy of a patient. In addition, the joint is able to withstand high tensile and torque loads without breaking. Load test have shown the joint of the previously described embodiment can withstand in excess of 2 pounds of tensile stress. In one embodiment, coil41 is made of a radiopaque material to also function as a proximal radiopaque marker.
• FIG. 28A depicts an alternative proximal wire segment construction. As shown, theproximal wire segment4002 comprises afirst section4002aand asecond section4002b, with thesecond section4002bhaving a width W greater than the width of the first section. In one implementation a taperedtransition section4003 joins the first andsecond sections4002aand4002b. In one implementation the width of thefirst section4002ais about 0.0063 inches while the width W of the second section is between about 0.0085 inches and about 0.0105 inches. In one implementation the length L between theproximal end4005 of theexpandable member4004 andsecond section4002bof thewire segment4002 is between about 0.017 inches and about 0.022 inches. An advantage of the inclusion of thesecond section4002bis that the greater width dimension provides a larger surface area for bonding thewire segment4002 to theelongate wire40 used in the delivery and retraction of the elongate member from a duct of a patient. In one implementation thefirst section4002ahas a circular or substantially circular construction and thesecond section4002bhas a flat profile formed by a pressing/coining operation.
• In the embodiment ofFIGS. 1A and 1B,expandable member12 includes a plurality of generally longitudinalundulating elements24 with adjacent undulating elements being out-of-phase with one another and connected in a manner to form a plurality of diagonally disposedcell structures26. Theexpandable member12 includes aproximal end portion14, a cylindricalmain body portion16 and adistal end portion18 with thecell structures26 in themain body portion16 extending continuously and circumferentially around alongitudinal axis30 of theexpandable member12. Thecell structures26 in theproximal end portion14 anddistal end portion18 extend less than circumferentially around thelongitudinal axis30 of theexpandable member12.
• In one embodiment,expandable member12 has an overall length of about 33.0 millimeters with themain body portion16 measuring about 16.0 millimeters in length and the proximal anddistal end portions14 and18 each measuring about 7.0 millimeters in length. In alternative embodiments, the length of themain body portion16 is generally between about 2.5 to about 3.5 times greater than the length of the proximal anddistal end portions14 and18.
• In use,expandable member12 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state (not shown) of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the first nominal diameter (e.g., average diameter of main body portion16) ranges between about 0.017 to about 0.030 inches, whereas the second nominal diameter (e.g., average diameter of main body portion16) is between about 2.5 to about 5.0 millimeters. In one implementation, the dimensional and material characteristics of thecell structures26 residing in themain body portion16 of theexpandable material12 are selected to produce sufficient radial force and contact interaction to cause thecell structures26 to engage with an embolic obstruction residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient. In alternative embodiments the dimensional and material characteristics of thecell structures26 in themain body portion16 are selected to produce a radial force per unit length of between about 0.005 N/mm to about 0.050 N/mm, preferable between about 0.010 N/mm to about 0.050 N/mm, and more preferably between about 0.030 N/mm and about 0.050 N/mm. In one embodiment, the diameter of themain body portion16 in a fully expanded state is about 4.0 millimeters with the cell pattern, strut dimensions and material being selected to produce a radial force of between about 0.040 N/mm to about 0.050 N/mm when the diameter of the main body portion is reduced to between about 1.0 millimeters to about 1.5 millimeters. In the same or alternative embodiment, the cell pattern, strut dimensions and material(s) are selected to produce a radial force of between about 0.010 N/mm to about 0.020 N/mm when the diameter of the main body portion is reduced to 3.0 millimeters.
• In the embodiments ofFIGS. 1A and 1B, each of thecell structures26 are shown having the same dimensions with each cell structure including a pair ofshort struts32 and a pair oflong struts34. In an exemplary embodiment, struts32 have a length of between about 0.080 and about 0.100 inches, struts34 have a length of between about 0.130 and about 0.140 inches, with each ofstruts32 and34 having an as-cut width and thickness of about 0.003 inches and about 0.0045 inches, respectively, and a post-polishing width and thickness of between about 0.0022 inches and about 0.0039 inches, respectively. An advantage of having a strut thickness to width ratio of greater than one is that it promotes integration of the strut into the embolic obstruction. In alternative embodiments, the post-polishing width and thickness dimensions varies between about 0.0020 inches to about 0.0035 and about 0.0030 inches to about 0.0040 inches, respectively, with the thickness to width ratio varying between about 1.0 to about 2.0, and preferably between about 1.25 to about 1.75.
• In one embodiment, only the strut elements of themain body portion16 have a thickness to width dimension ratio of greater than one. In another embodiment, only the strut elements of themain body portion16 anddistal end portion18 have a thickness to width dimension ratio of greater than one. In another embodiment, only a portion of the strut elements have a thickness to width dimension ratio of greater than one. In yet another embodiment, strut elements in different parts of the expandable member have different thickness to width dimension ratios, the ratios in each of the parts being greater than one. As an example, because the radial force exerted by theproximal end portion14 anddistal end portion18 of theexpandable member12 may generally be less than the radial force exerted by themain body portion16, the strut elements in the distal and/or proximal end portions can have a thickness to width ratio that is greater than the thickness to width ratio of the struts in themain body portion16. An advantage of this construction is that the ability of theexpandable member12 to integrate into an embolic obstruction is made to be more uniform along the length of the expandable member.
• In other embodiments, certain, or all of the strut elements have a tapered shape with the outer face of the strut having a width dimension less than the width dimension of the inner face of the strut. In other embodiments, theexpandable member12 may comprise strut elements having a generally rectangular cross-section and also strut elements having a tapered shape.
• It is important to note that the present invention is not limited toexpandable members12 having uniform cell structures nor to any particular dimensional characteristics. As an example, in alternative embodiments thecell structures26 in the proximal and/ordistal end portions14 and18 are either larger or smaller in size than thecell structures26 in themain body portion16. In one embodiment, thecell structures26 in the proximal anddistal end portions14 and18 are sized larger than those in themain body portion16 so that the radial forces exerted in theend portions14 and18 are lower than the radial forces exerted in themain body portion16.
• The radial strength along the length of theexpandable member12 may be varied in a variety of ways. One method is to vary the mass (e.g., width and/or thickness) of the struts along the length of theexpandable member12. Another method is to vary the size of thecell structures26 along the length of theexpandable member12. The use of smaller cell structures will generally provide higher radial forces than those that are larger. Varying the radial force exerted along the length of the expandable member can be particularly advantageous for use in entrapping and retrieving embolic obstructions. For example, in one embodiment the radial force in the distal section of themain body portion16 of theexpandable member12 in its expanded state is made to be greater than the radial force in the proximal section of themain body portion16. Such a configuration promotes a larger radial expansion of the distal section of themain body portion16 into the embolic obstruction as compared to the proximal section. Because theexpandable member12 is pulled proximally during the removal of the embolic obstruction from the patient, the aforementioned configuration will reduce the likelihood of particles dislodging from the embolic obstruction during its removal. In an alternative embodiment the radial force in the proximal section of themain body portion16 of theexpandable member12 in its expanded state is made to be greater than the radial force in the distal section of themain body portion16. In yet another embodiment, themain body portion16 of theexpandable member12 includes a proximal section, a midsection and a distal section with the radial force in the proximal and distal sections being larger than the radial force in the midsection when theexpandable member12 is in an expanded state.
• In alternative embodiments, as exemplified inFIG. 9, themain body portion16 may include an increased diameter portion orbulge70 to enhance the expandable member's ability to entrap or otherwise engage with an embolic obstruction. InFIG. 9, a single increaseddiameter portion70 is provided within the midsection ofmain body portion16. In alternative embodiments, the increaseddiameter portion70 may be positioned proximally or distally to the midsection. In yet other embodiments, two or more increaseddiameter portions70 may be provided along the length of themain body portion16. In one implementation, the two or more increaseddiameter portions70 have essentially the same manufactured nominal diameter. In another implementation, the distal-most increaseddiameter portion70 has a greater manufactured nominal diameter than the proximally disposed increased diameter portions. In alternative exemplary embodiments the nominal diameter of the increaseddiameter portion70 is between about 25.0 to about 45.0 percent greater than the nominal diameter of the main body portion. For example, in one embodiment, the nominal expanded diameter ofmain body portion16 is about 3.0 millimeters and the nominal diameter of the increaseddiameter portion70 is about 4.0 millimeters. In another embodiment the nominal expanded diameter ofmain body portion16 is about 3.50 millimeters and the nominal diameter of the increaseddiameter portion70 is about 5.00 millimeters. In one embodiment, the one or more increaseddiameter portions70 are formed by placing an expandable mandrel into the internal lumen of themain body portion16 and expanding the mandrel to create the increaseddiameter portion70 of a desired diameter. In another embodiment, one or more of the increaseddiameter portions70 are formed by placing a mandrel of a given width and diameter into themain body portion16 and then crimping theexpandable member12 in a manner to cause at least a portion of themain body portion16 to be urged against the mandrel.
• In one embodiment, the strut elements in the increased diameter portion orportions70 have a thickness dimension to width dimension ratio that is greater than the thickness to width ratio of the other struts in themain body portion16. In yet another embodiment, the strut elements in the increased diameter portion orportions70 have a thickness dimension to width dimension ratio that is less than the thickness to width ratio of the other struts in themain body portion16.
• In one implementation, adistal wire segment50, that is attached to or integrally formed withexpandable member12, extends distally from thedistal end22 of theexpandable member12 and is configured to assist in guiding the delivery of the expandable member to the treatment site of a patient.FIG. 2 shows adistal wire segment50 in one embodiment having a first section52 of a uniform cross-section and asecond section54 having a distally tapering cross-section. In an exemplary embodiment, the first section52 has a length of about 3.0 millimeters and an as-cut cross-sectional dimension of about 0.0045 inches by about 0.003 inches, and whereas thesecond section54 has a length of about 4.0 millimeters and tapers to a distal-most, as-cut, cross-sectional dimension of about 0.002 inches by about 0.003 inches. Post-polishing of the device generally involves an etching process that typically results in a 40% to 50% reduction in the as-cut cross-sectional dimensions. In another embodiment, as depicted inFIG. 3, thedistal wire segment50 is bound by aspring member57 of a uniform diameter and is equipped with an atruamaticdistal tip58. In alternative embodiments, thespring element57 and/or theatraumatic tip58 are made or coated with of a radiopaque material, such as, for example, platinum.
• FIG. 28billustrates an alternative distal wire segment construction. As depicted, thedistal wire segment4010 includes afirst section4011aand asecond section4011b, thesecond section4011bhaving a width W greater than the width of thefirst section4011a. In one implementation a taperedtransition section4012 joins the first andsecond sections4011aand4011b. In one implementation the width W of the second section is between about 0.003 inches and about 0.004 inches with the length L between thedistal end4013 of theexpandable member4014 and thesecond section4011bof thewire segment4010 being between about 0.015 inches and about 0.020 inches. An advantage of the inclusion of thesecond section4011bis that the greater width dimension provides a larger surface area for bonding a coil/spring segment57 to thewire segment4010. In one implementation thefirst section4011ahas a circular or substantially circular construction and thesecond section4011bhas a flat profile formed by a pressing/coining operation.
• In one embodiment, as will be described in more detail below, theexpandable member12 is delivered to the treatment site of a patient through the lumen of a delivery catheter that has been previously placed at the treatment site. In an alternative embodiment, thevascular treatment device10 includes a sheath that restrains theexpandable member12 in a compressed state during delivery to the treatment site and which is proximally retractable to cause theexpandable member12 to assume an expanded state.
• In one implementation, theexpandable member12 in the expanded state is able to engage an embolic obstruction residing at the treatment site, for example by embedding itself into the obstruction, and is removable from the patient by pulling on a portion of the elongateflexible wire40 residing outside the patient until theexpandable member12 and at least a portion of the embolic obstruction are removed from the patient.
• The use of interconnected and out-of-phase undulating elements24 to create at least some of thecell structures26 in alternative embodiments provides several advantages. First, the curvilinear nature of thecell structures26 enhances the flexibility of theexpandable member12 during its delivery through the tortuous anatomy of the patient to the treatment site. In addition, the out-of-phase relationship between the undulating elements facilitates a more compact nesting of the expandable member elements permitting theexpandable member12 to achieve a very small compressed diameter. A particular advantage of the expandable member strut pattern shown inFIG. 1A, and various other embodiments described herein, is that they enable sequential nesting of the expandable member elements which permit the expandable members to be partially or fully deployed and subsequently withdrawn into the lumen of a delivery catheter. The out-of-phase relationship also results in a diagonal orientation of thecell structures26 which may induce a twisting action as theexpandable member12 transitions between the compressed state and the expanded state that helps the expandable member to better engage with the embolic obstruction. In alternative embodiments, thecell structures26 of theexpandable member12 are specifically arranged to produce a desired twisting action during expansion of theexpandable member12. In this manner, different expandable members each having different degrees of twisting action may be made available to treat, for example, different types of embolic obstructions.
• To enhance visibility of the device under fluoroscopy, the expandable member may be fully or partially coated with a radiopaque material, such as tungsten, platinum, platinum/iridium, tantalum and gold. Alternatively, or in conjunction with the use of a radiopaque coating,radiopaque markers60 may be positioned at or near the proximal anddistal ends20 and22 of the expandable device and/or along the proximal anddistal wire segments42 and50 and/or on selected expandable member strut segments. In one embodiment, theradiopaque markers60 are radiopaque coils, such as platinum coils.
• FIG. 4A depicts avascular treatment device100 in a two-dimensional plane view in another embodiment of the present invention. In its manufactured and/or expanded tubular configuration,device100 has a similar construction asdevice10 shown inFIG. 1B. Likedevice10 described above in conjunction withFIGS. 1A and 1B,device100 includes a self-expandable member112 that is coupled to an elongateflexible wire140. Theexpandable member112 includes aproximal end portion114, a cylindricalmain body portion116 and adistal end portion118. As mentioned above, delivery of theexpandable member112 in its unexpanded state to the treatment site of a patient is accomplished in one manner by placing theexpandable member112 into the proximal end of a delivery catheter and pushing theexpandable member112 through the lumen of the delivery catheter until it reaches a distal end of the catheter that has been previously placed at or across the treatment site. The proximally extending elongateflexible wire140 which is attached to or coupled to theproximal end120 of theexpandable member112 is designed to transmit a pushing force applied to it to its connection point with the elongateflexible member112. As shown inFIG. 4A, and in more detail inFIG. 4B,device100 is distinguishable from the various embodiments ofdevice10 described above in that theproximal-most cell structures128 and130 in theproximal end portion114 include strut elements having a width dimension W1 larger than the width dimension W2 of the other strut elements within theexpandable member112. As shown, theproximal-most wall sections160,162 and164 ofcell structures128 are made of struts having width W1. Moreover, all the struts of theproximal-most cell structure130 have an enhanced width W1. The inclusion and placement of the struts with width W1 provides several advantages. One advantage is that they permit the push force applied by the distal end of theelongate wire140 to theproximal end120 ofelongate member112 to be more evenly distributed about the circumference of theexpandable member112 as it is being advanced through the tortuous anatomy of a patient. The more evenly distributed push force minimizes the formation of localized high force components that would otherwise act on individual or multiple strut elements within theexpandable member112 to cause them to buckle. Also, by including the struts of width W1 in the peripheral regions ofproximal end portion114, they greatly inhibit the tendency of theproximal end portion114 to buckle under the push force applied to it byelongate wire140. In one exemplary embodiment the as-cut width dimension W1 is about 0.0045 inches and the as-cut width dimension W2 is about 0.003 inches. As discussed above, post-polishing of the device generally involves an etching process that typically results in a 40% to 50% reduction in the as-cut cross-sectional dimensions.
• It is important to note that although the width dimension W1 is shown as being the same among all struts having an enhanced width, this is not required. For example, in oneembodiment wall segments158 may have an enhanced width dimension greater than the enhanced width dimension ofwall segments160, andwall segments160 may have an enhanced width dimension greater than the enhanced width dimension ofwall segments162, and so on. Moreover, theinner strut elements166 of theproximal-most cell structure130 may have an enhanced width dimension less than the enhanced width dimensions ofstruts158. Also, in alternative embodiments, the radial thickness dimension ofstruts158,160,162,164, etc. may be enhanced in lieu of the width dimension or in combination thereof.
• In yet another embodiment, as shown inFIG. 5, some of thestrut elements180 in thedistal end portion118 of theexpandable member112 have a mass greater than that of the other struts to resist buckling and possible breaking of the struts asdevice100 is advanced to a treatment site of a patient. In the embodiment shown, struts180 are dimensioned to have the same width asdistal wire segment150. In alternative embodiments, the thickness dimension ofstruts180 may be enhanced in lieu of the width dimension or in combination thereof.
• FIGS. 6A and 6B illustrate avascular treatment device200 in accordance with another embodiment of the present invention.FIG. 6A depictsdevice200 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 6B depicts the device in its manufactured and/or expanded tubular configuration.Device200 includes anexpandable member212 having aproximal end portion214, a cylindrical main body portion216 and adistal end portion218 with an elongateflexible wire240 attached to or otherwise coupled to theproximal end220 of the expandable member. The construction ofdevice200 is similar todevice100 described above in conjunction withFIGS. 4A except that theproximal wall segments260 ofcell structures228 and230 comprise linear or substantially linear strut elements as viewed in the two dimension plane view ofFIG. 6A. In one embodiment, thelinear strut elements260 are aligned to form continuous and substantiallylinear rail segments270 that extend from theproximal end220 ofproximal end portion214 to a proximal-most end of main body portion216 (again, as viewed in the two dimension plane view ofFIG. 6A) and preferably are of the same length, but may be of different lengths. When the pattern ofFIG. 6A is applied to laser cutting a tubular structure, the resulting expandable member configuration is that as shown inFIG. 6B. As shown inFIG. 6B,rail segments270 are not in fact linear but are of a curved and non-undulating shape. This configuration advantageously providesrail segments270 devoid of undulations thereby enhancing the rail segments' ability to distribute forces and resist buckling when a push force is applied to them. In alternative preferred embodiments, the angle θ between thewire segment240 andrail segments270 ranges between about 140 degrees to about 150 degrees. In one embodiment, one or both of thelinear rail segments270 have a width dimension W1 which is greater than the width dimension of the adjacent strut segments ofcell structures228 and230. An enhanced width dimension W1 of one or both thelinear rail segments270 further enhances the rail segments' ability to distribute forces and resist buckling when a push force is applied to them. In another implementation, one or both of thelinear rail segments270 are provided with an enhanced thickness dimension, rather than an enhanced width dimension to achieve the same or similar result. In yet an alternative implementation, both the width and thickness dimensions of one or both of thelinear rail segments270 are enhanced to achieve the same or similar results. In yet another implementation, the width and/or thickness dimensions of each of therail segments270 differ in a manner that causes a more even compression of theproximal end portion214 of theexpandable member212 when it is loaded or retrieved into a delivery catheter or sheath (not shown).
• FIGS. 7A and 7B illustrate avascular treatment device300 in accordance with another embodiment of the present invention.FIG. 7A depictsdevice300 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 7B depicts the device in its manufactured and/or expanded tubular configuration.Device300 includes anexpandable member312 having aproximal end portion314, a cylindricalmain body portion316 and adistal end portion318 with an elongateflexible wire340 attached to or otherwise coupled to theproximal end320 of the expandable member. The construction ofdevice300 is similar todevice200 described above in conjunction withFIGS. 6A and 6B except that theproximal-most cell structure330 comprises a substantially diamond shape as viewed in the two-dimensional plane ofFIG. 7A. The substantially diamond-shaped cell structure includes a pair ofouter strut elements358 and a pair ofinner strut elements360, each having an enhanced width and/or enhanced thickness dimension as previously discussed in conjunction with the embodiments ofFIGS. 4 and 6. In alternative preferred embodiments, theinner strut elements360 intersect theouter strut elements358 at an angle β between about 25.0 degrees to about 45.0 degrees as viewed in the two-dimensional plane view ofFIG. 7A. Maintaining the angular orientation between the inner and outer struts within in this range enhances the pushabilty of theexpandable member312 without the occurrence of buckling and without substantially affecting the expandable member's ability to assume a very small compressed diameter during delivery.
• In one embodiment, theinner strut elements360 have a mass less than that of theouter strut elements358 that enables them to more easily bend as theexpandable member312 transitions from an expanded state to a compressed state. This assists in achieving a very small compressed diameter. In another embodiment, as shown inFIG. 7C, theinner strut elements360 are coupled to theouter strut elements358 bycurved elements361 that enable theinner strut elements360 to more easily flex when theexpandable member312 is compressed to its delivery position.
• FIG. 8 illustrates an alternative embodiment of avascular treatment device400.Device400 has a similar construction to that ofdevice200 depicted inFIGS. 6A and 6B with the exception that theexpandable member412 ofdevice400 is connected at itsproximal end portion414 with two distally extending elongateflexible wires440 and441. As illustrated,wire440 is attached to or otherwise coupled to theproximal-most end420 ofproximal end portion414, whilewire441 is attached to or otherwise coupled to thedistal-most end422 of theproximal end portion414 at the junction with rail segment470. In yet another embodiment, an additional elongate flexible wire (not shown) may be attached to thedistal-most end424. The use of two or more elongateflexible wires440 and441 to provide pushing forces to theproximal end portion414 ofelongate member412 advantageously distributes the pushing force applied to theproximal end portion414 to more than one attachment point.
• FIG. 10 illustrates a two-dimensional plane view of avascular treatment device500 in another embodiment of the present invention. In the embodiment ofFIG. 10,expandable member512 includes a plurality of generally longitudinalundulating elements524 with adjacent undulating elements being out-of-phase with one another and connected in a manner to form a plurality of diagonally disposedcell structures526. Theexpandable member512 includes acylindrical portion516 and adistal end portion518 with thecell structures526 in themain body portion516 extending continuously and circumferentially around alongitudinal axis530 of theexpandable member512. Thecell structures526 in thedistal end portion518 extend less than circumferentially around thelongitudinal axis530 of theexpandable member512. Attached to or otherwise coupled to each of theproximal-most cell structures528 are proximally extending elongateflexible wires540. The use of multiple elongateflexible wires540 enables the pushing force applied to the proximal end of theexpandable member512 to be more evenly distributed about its proximal circumference. In another embodiment, although not shown inFIG. 10, theproximal-most strut elements528 have a width and/or thickness greater than the struts in the other portions of theexpandable member512. Such a feature further contributes to the push force being evenly distributed about the circumference of theexpandable member512 and also inhibits the strut elements directly receiving the push force from buckling.
• FIGS. 11A and 11B illustrate avascular treatment device600 in accordance with another embodiment of the present invention.FIG. 11A depictsdevice600 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 11B depicts the device in its manufactured and/or expanded tubular configuration. In the embodiment ofFIGS. 11A and 11B,expandable member612 includes a plurality of generally longitudinalundulating elements624 with adjacent undulating elements being interconnected by a plurality ofcurved connectors628 to form a plurality of closed-cell structures626 disposed about the length of theexpandable member612. In the embodiment shown, theexpandable member612 includes aproximal end portion614 and acylindrical portion616 with thecell structures626 in thecylindrical portion616 extending continuously and circumferentially around alongitudinal axis630 of theexpandable member612.
• Thecell structures626 in theproximal end portion614 extend less than circumferentially around thelongitudinal axis630 of theexpandable member612. In an alternative embodiment, theexpandable member612 includes a proximal end portion, a cylindrical main body portion and a distal end portion, much like theexpandable member12 depicted inFIGS. 1A and 1B. In such an embodiment, thecell structures626 in the distal end portion of the expandable member would extend less than circumferentially around thelongitudinal axis630 of theexpandable member612 in a manner similar to theproximal end portion614 shown inFIG. 11A. Moreover, it is appreciated that the expandable members ofFIGS. 1A, 4A, 6A, 7A, 7C, 10, 14, 15 and 19-24 may be modified in a way so as to eliminate the distal end portion (e.g.,distal end portion18 inFIG. 1A) so that there exists only a proximal end portion and main body portion like that ofFIG. 11A.
• FIG. 12 illustrates avascular treatment device700 in accordance with another embodiment of the present invention.FIG. 12 depictsdevice700 in a two-dimensional plane view as if the device were cut and laid flat on a surface. In the embodiment ofFIG. 12,expandable member712 includes a plurality of generally longitudinalundulating elements724 with adjacent undulating elements being interconnected by a plurality ofcurved connectors728 to form a plurality of closed-cell structures726 disposed about the length of theexpandable member712. In the embodiment shown, theexpandable member712 includes acylindrical portion716 and adistal end portion718 with thecell structures726 in thecylindrical portion716 extending continuously and circumferentially around alongitudinal axis730 of theexpandable member712. Thecell structures726 in thedistal end portion718 extend less than circumferentially around thelongitudinal axis730 of theexpandable member712. In a manner similar to that described in conjunction with the embodiment ofFIG. 10, attached to or otherwise coupled to each of theproximal-most cell structures728 are proximally extending elongateflexible wires740. This arrangement enables the pushing force applied to the proximal end of theexpandable member712 to be more evenly distributed about its proximal circumference. In another embodiment, although not shown inFIG. 12, theproximal-most strut elements730 have a width and/or thickness greater than the struts in the other portions of theexpandable member712. Such a feature further contributes to the push force being evenly distributed about the circumference of theexpandable member712 and also inhibits the strut elements directly receiving the push force from buckling.
• As previously discussed, in use, the expandable members of the present invention are advanced through the tortuous vascular anatomy of a patient to a treatment site, such as an embolic obstruction, in an unexpanded or compressed state of a first nominal diameter and are movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. One manner of delivering and deployingexpandable member912 at the site of anembolic obstruction950 is shown inFIGS. 13A through 13C. As shown inFIG. 13A, adelivery catheter960 having aninner lumen962 is advanced to the site of theembolic obstruction950 so that itsdistal end964 is positioned distal to the obstruction. After thedelivery catheter960 is in position at theembolic obstruction950, theretrieval device900 is placed into the delivery catheter by introducing theexpandable member912 into a proximal end of the delivery catheter (not shown) and then advancing theexpandable member912 through thelumen962 of the delivery catheter by applying a pushing force to elongateflexible wire940. By the use of radiopaque markings and/or coatings positioned on thedelivery catheter960 anddevice900, theexpandable member912 is positioned at the distal end of thedelivery catheter960 as shown inFIG. 13B so that themain body portion916 is longitudinally aligned with theobstruction950. Deployment of theexpandable member912 is achieved by proximally withdrawing thedelivery catheter960 while holding theexpandable member912 in a fixed position as shown inFIG. 13C. Once theexpandable member912 has been deployed to an expanded position within theobstruction950, theexpandable member912 is retracted, along with thedelivery catheter960, to a position outside the patient. In one embodiment, theexpandable member912 is first partially retracted to engage with thedistal end964 of thedelivery catheter960 prior to fully retracting the devices from the patient.
• In one embodiment, once theexpandable member912 is expanded at theobstruction950, it is left to dwell there for a period of time in order to create a perfusion channel through the obstruction that causes the obstruction to be lysed by the resultant blood flow passing through the obstruction. In such an embodiment, it is not necessary that theexpandable member912 capture a portion of theobstruction950 for retrieval outside the patient. When a sufficient portion of theobstruction950 has been lysed to create a desired flow channel through the obstruction, or outright removal of the obstruction is achieved by the resultant blood flow, theexpandable member912 may be withdrawn into thedelivery catheter960 and subsequently removed from the patient.
• In another embodiment, theexpandable member912 is expanded at theobstruction950 and left to dwell there for a period of time in order to create a perfusion channel through the obstruction that causes the obstruction to be acted on by the resultant flow in a manner that makes the embolic obstruction more easily capturable by the expandable member and/or to make it more easily removable from the vessel wall of the patient. For example, the blood flow created through the embolic obstruction may be made to flow through the obstruction for a period of time sufficient to change the morphology of the obstruction that makes it more easily captured by the expandable member and/or makes it more easily detachable from the vessel wall. As in the preceding method, the creation of blood flow across theobstruction950 also acts to preserve tissue. In one embodiment, the blood flow through the obstruction may be used to lyse the obstruction. However, in this modified method, lysing of the obstruction is performed for the purpose of preparing the obstruction to be more easily captured by theexpandable member912. When theobstruction950 has been properly prepared, for example by creating anobstruction950 of a desired nominal inner diameter, theexpandable member912 is deployed from thedistal end964 of thedelivery catheter940 to cause it to engage with the obstruction. Removal of all, or a portion, of theobstruction950 from the patient is then carried out in a manner similar to that described above.
• In yet another embodiment, once theexpandable member912 has been delivered and expanded inside theobstruction950, it may be detached from theelongate wire940 for permanent placement within the patient. In such an embodiment, the manner in which theelongate wire940 is attached to theexpandable member912 allows the two components to be detached from one another. This may be achieved, for example, by the use of a mechanical interlock or an erodable electrolytic junction between theexpandable member912 and theelongate wire940.
• As described herein, the expandable members of the various embodiments may or may not include distal wire segments that are attached to their distal ends. In alternative preferred embodiments, vascular treatment devices that are configured to permanently place an expandable member at the site of an embolic obstruction do not include distal wire segments attached to the distal ends of the expandable members.
• One advantage associated with the expandable member cell patterns of the present invention is that withdrawing the expandable members by the application of a pulling force on the proximal elongate wire flexible wire urges the expandable members to assume a smaller expanded diameter while being withdrawn from the patient, thus decreasing the likelihood of injury to the vessel wall. Also, during clot retrieval as the profile of the expandable members decrease, the cell structures collapse and pinch down on the clot to increase clot retrieval efficacy. Another advantage is that the cell patterns permit the expandable members to be retracted into the lumen of the delivery catheter after they have been partially or fully deployed. As such, if at any given time it is determined that the expandable member has been partially or fully deployed at an improper location, it may be retracted into the distal end of the delivery catheter and repositioned to the correct location.
• With reference toFIG. 14, a modified version of thevascular treatment device200 ofFIG. 6A is shown that includesthin strut elements280 intersecting at least some of thecell structures226 located in the cylindrical main body portion216 ofexpandable member212. Thethin strut elements280 are dimensioned to have a width of less than thestrut elements282 that form thecell structures226. In alternative exemplary embodiments, strutelements280 have an as-cut or polished width dimension that is between about 25% to about 50% smaller than the respective as-cut or polished width dimension of struts262. When used for the purpose of clot retrieval, a purpose of thethin struts280 is to enhance the expandable member's ability to engage with and capture an embolic obstruction. This is accomplished by virtue of several factors. First, the thinner width dimensions of thestruts280 make it easier for the struts to penetrate the obstruction. Second, they act to pinch portions of the entrapped obstruction against the outer andwider strut elements282 as the expandable member is deployed within the obstruction. Third, they may be used to locally enhance radial forces acting on the obstruction. It is important to note that the use ofthin strut elements280 is not limited to use withincell structures226 that reside within the cylindrical main body portion216 of theexpandable member212. They may be strategically positioned in any or all of the cell structures of the expandable member. Moreover, it is important to note that the use ofthin strut elements280 is not limited to the embodiment ofFIGS. 6, but are applicable to all the various embodiments disclosed herein. Lastly, in alternative exemplary embodiments, as shown inFIG. 15, multiplethin strut elements280 are provided within one or more of thecell structures226, and may also be used in conjunction with cell structures that have a single thin strut element and/or cell structures altogether devoid of thin strut elements.
• In the treatment of aneurysms when the treatment device is used for the purpose of diverting flow, the density of thecell structures226 is sufficient to effectively divert flow away from the aneurysm sack. In alternative embodiments in lieu of, or in combination with adjusting the density of thecell structures226, intermediate strut elements similar to thestrut elements280 ofFIGS. 14 and 15 are used to increase the effective wall surface of the expandable member. In these embodiments, the intermediate strut elements may have the same, smaller, larger, or any combination thereof, dimensional characteristics of the cell structure struts. Conversely, in alternative embodiments for use in the treatment of aneurysms for the purpose placing coils or other like structures within the sack of the aneurysm, the size of thecell structures226 is sufficient to facilitate passage of the coils through the cell structures.
• FIG. 16 illustrates a treatment device according to the embodiment ofFIGS. 6A and 6B, wherein the pushability of theexpandable member212 during its advancement to the treatment site of a patient is enhanced by the inclusion of aninternal wire segment241 that extends between theproximal end220 anddistal end222 of theexpandable member212. In this manner, the pushing force applied byelongate wire240 is transmitted to both the proximal and distal ends of expandable device. The internal wire segment may be a discrete element that is attached to the proximal and distal ends of the expandable member, or may preferably be a co-extension of the elongateflexible wire240. During delivery of theexpandable member212 to the treatment site in its compressed state, theinternal wire segment241 assumes a substantially straight or linear configuration so as to adequately distribute at least a part of the pushing force to thedistal end222 of the expandable member. When theexpandable member212 expands, it tends to foreshorten causing slack in theinternal wire segment241 that forms a long-pitched helix within the expandable member as shown inFIG. 16. An additional advantage associated with the use theinternal wire segment241 is that the formation of the internal helix upon expansion of theexpandable member212 assists in capturing the embolic obstruction.
• In an alternative embodiment, as shown inFIG. 17, the pushability of theexpandable member212 during its advancement to the treatment site of a patient is enhanced by the inclusion of anexternal wire segment243 that extend between theproximal end220 anddistal end222 of theexpandable member212. In this manner, the pushing force applied by theelongate wire240 is transmitted to both the proximal and distal ends of the expandable device. The external wire segment may be discrete element that is attached to the proximal and distal ends of the expandable member, or may preferably be a co-extension of the elongateflexible wire240. During delivery of theexpandable member212 to the treatment site in its compressed state, theexternal wire segment243 assumes a substantially straight or linear configuration so as to adequately distribute at least a part of the pushing force to thedistal end222 of the expandable member. When theexpandable member212 expands, it tends to foreshorten causing slack in theexternal wire segment243 as shown inFIG. 17. An additional advantage associated with the use of theexternal wire segment243 is that it directly acts on the obstruction while theexpandable member212 is expanded to assist in engaging and capturing the embolic obstruction.
• In yet another embodiment, a distalemboli capture device251 is disposed on thedistal wire segment250, or otherwise attached to thedistal end222, ofexpandable member212 as shown inFIG. 18. The function of the distalemboli capture device251 is to capture emboli that may be dislodged from the embolic obstruction during the expansion of theexpandable member212 or during its removal from the patient to prevent distal embolization. InFIG. 18, the distal emboli capture device is shown as a coil. In alternative embodiments, baskets, embolic filters or other known emboli capture devices may be attached to thedistal end222 ordistal wire segment250 ofexpandable member12.
• Again, as with the embodiments ofFIGS. 14 and 15, it is important to note that the features described in conjunction withFIGS. 16, 17 and 18 are not limited to the embodiment ofFIGS. 6, but are applicable to all the various embodiments disclosed herein.
• FIG. 19 illustrates a bodily duct orvascular treatment device1000 in accordance with another embodiment of the present invention.FIG. 19 depictsdevice1000 in a two-dimensional plane view as if the device were cut and laid flat on a surface.Device1000 includes anexpandable member1012 having aproximal end portion1024, a cylindricalmain body portion1026 and adistal end portion1028 with an elongate flexible wire1014 attached to or otherwise coupled to theproximal end1020 of the expandable member. The construction ofdevice1000 is similar todevice200 described above in conjunction withFIGS. 6A except that thecell structures1018 and1019 in theproximal end portion1024 are more closely symmetrically arranged than the cell structures in theproximal end portion214 ofdevice200. The more substantial symmetrical arrangement of the cell structures in theproximal end portion1024 ofdevice1000 facilitates the loading or retrieval of theexpandable member1012 into a lumen of a delivery catheter or sheath (not shown) by causing theproximal end portion1024 to collapse more evenly during compression. Theproximal wall segments1016 ofcell structures1018 and1019 comprise linear or substantially linear strut elements as viewed in the two dimension plane view ofFIG. 19. In one embodiment, thelinear strut elements1016 are aligned to form continuous and substantiallylinear rail segments1017 that extend from theproximal end1020 ofproximal end portion1024 to a proximal-most end of main body portion1026 (again, as viewed in the two dimension plane view ofFIG. 19) and preferably are of the same length. In alternative embodiments, the angle θ between the wire segment1014 andrail segments1017 ranges between about 140 degrees to about 150 degrees. In one embodiment, one or both of thelinear rail segments1017 have a width dimension W1 which is greater than the width dimension of the adjacent strut segments ofcell structures1018 and/or1019 and/or1030. An enhanced width dimension W1 of one or both thelinear rail segments1017 further enhances the rail segments' ability to distribute forces and resist buckling when a push force is applied to them. In another implementation, one or both of thelinear rail segments1017 are provided with an enhanced thickness dimension, rather than an enhanced width dimension to achieve the same or similar result. In yet an alternative implementation, both the width and thickness dimensions of one or both of thelinear rail segments1017 are enhanced to achieve the same or similar results. In yet another implementation, the width and/or thickness dimensions of each of therail segments1017 differ in a manner that causes a more even compression of theproximal end portion1024 of theexpandable member1012 when it is collapsed as it is loaded or retrieved into a delivery catheter or sheath.
• Although the description that follows is directed to the embodiment ofFIG. 19, it is important to note that the provision of a slit as contemplated by the embodiments ofFIGS. 20-22 are applicable to all the vascular treatment devices described herein, and their numerous embodiments and modifications thereof.
• Turning now toFIG. 20, thetreatment device1000 ofFIG. 19 is depicted having alongitudinal slit1040 that extends from theproximal end1020 to thedistal end1022 of theexpandable member1012. Theslit1040 permits thecell structures1018,1019 and1030 to move relative to one another in a manner that inhibits theindividual strut elements1032 of theexpandable member1012 from buckling during compression of theexpandable member1012 as it is loaded or retrieved into a delivery catheter or sheath. In alternative embodiments, slit1040 extends less than the entire length ofexpandable member1012 and is arranged to inhibit buckling of strategically important strut elements that most affect the expandable member's ability to be effectively loaded or withdrawn into a delivery catheter or sheath. For example, in one embodiment, slit1040 is provided only in theproximal end portion1024 of theexpandable member1012 where the likelihood of buckling or bending ofstruts1032 is most likely to occur. In another embodiment, slit1040 is provided in both theproximal end portion1024 and the cylindricalmain body portion1026 ofexpandable member1012.
• FIG. 21 illustrates thetreatment device1000 ofFIG. 19 having a diagonally disposed/spiral slit1050 that extends the entire circumference of theexpandable member1012. In one embodiment, as illustrated inFIG. 21, thespiral slit1050 originates at the distal position, or at a point adjacent to the distal position, of theproximal end portion1024 ofexpandable member1012. With respect to the embodiments having linear rail segments, such as thelinear rail segments1017 ofFIG. 19, thespiral slit1050 originates at thedistal position1021 of one of thelinear rail segments1017, or at a point distally adjacent to thedistal position1021, as shown inFIG. 21. Testing of the various vascular treatment devices described herein has shown that the occurrence of buckling tends to occur at the strut elements located adjacent to the distal positions of the proximal end portions of the expandable members. This phenomenon is exacerbated in the expandable members having proximal end portions with linear rail segments. For this reason, and with reference toFIG. 21, the originating point ofspiral slit1050 is located at or adjacent to adistal position1021 of one of thelinear rail segments1017. An advantage of the diagonally disposed and/or spiral slit configuration ofFIG. 21 is that it originates where the buckling tends to originate and further inhibits buckling ofstrut elements1032 along the length of theexpandable member1012. As shown inFIG. 22, in alternative embodiments slit1050 extends diagonally along only a portion of the circumference of the cylindricalmain body portion1026 of theexpandable member1012. In the embodiment ofFIG. 22, slit1050 originates at thedistal position1021 oflinear rail segment1017. In alternative embodiments, where buckling ofindividual strut elements1032 originate at a point other than at the distal point of theproximal end portion1024 of theexpandable member1012, the originating point of theslit1050 is located at the origination point of the bucking (absent the slit1050) and extends in a longitudinal direction distally therefrom.
• FIG. 23 illustrates a bodily duct orvascular treatment device2000 in accordance with an embodiment of the present invention.FIG. 23 depictsdevice2000 in a two-dimensional plane view as if the device were cut and laid flat on a surface.Device2000 includes a self-expandable member2012 that is attached or otherwise coupled to an elongateflexible wire2040 that extends proximally from theexpandable member2012. In one embodiment, theexpandable member2012 is made of shape memory material, such as Nitinol, and is preferably laser cut from a tube. In one embodiment, theexpandable member2012 has an integrally formed proximally extendingwire segment2042 that is used to join the elongateflexible wire2040 to theexpandable member2012. In such an embodiment,flexible wire2040 may be joined towire segment2042 by the use of solder, a weld, an adhesive, or other known attachment method. In an alternative embodiment, the distal end offlexible wire2040 is attached directly to aproximal end2020 of theexpandable member2012.
• In the embodiment ofFIG. 23,expandable member2012 includes a plurality of generally longitudinalundulating elements2024 with adjacent undulating elements being coupled to one another in a manner to form a plurality of circumferentially-alignedcell structures2026. Theexpandable member2012 includes aproximal end portion2013, a cylindricalmain body portion2014 and adistal end portion2015 with thecell structures2026 in themain body portion2014 extending continuously and circumferentially around alongitudinal axis2032 of theexpandable member2012. The cell structures in theproximal end portion2013 anddistal end portion2015 extend less than circumferentially around thelongitudinal axis2032 of theexpandable member2012. Theproximal wall segments2016 ofcell structures2027,2028,2029 and2030 comprise linear or substantially linear strut elements as viewed in the two dimension plane view ofFIG. 23. In one embodiment, thelinear strut elements2016 are aligned to form continuous and substantiallylinear rail segments2017 that extend from theproximal end2020 ofproximal end portion2013 to a proximal-most end of main body portion2014 (again, as viewed in the two dimension plane view ofFIG. 23) and preferably are of the same length. As described above in conjunction withFIGS. 6A and 6B,rail segments2017 are not in fact linear but are of a curved and non-undulating shape. This configuration advantageously providesrail segments2017 devoid of undulations thereby enhancing the rail segments' ability to distribute forces and resist buckling when a push force is applied to them. In alternative preferred embodiments, the angle θ between thewire segment2042 or2040, which ever the case may be, andrail segments2017 ranges between about 140 degrees to about 150 degrees. In one embodiment thelinear rail segments2017 have a width dimension which is greater than the width dimension of the adjacent strut segments ofcell structures2027 and/or2028 and/or2029 and/or2030 and/or2026. An enhanced width of thelinear rail segments2017 further enhances the rail segments' ability to distribute forces and resist buckling when a push force is applied to the expandable member. In another implementation thelinear rail segments2017 are provided with an enhanced thickness dimension, rather than an enhanced width dimension to achieve the same or similar result. In yet an alternative implementation, both the width and thickness dimensions of thelinear rail segments2017 are enhanced to achieve the same or similar results.
• In one embodiment, the width and/or thickness of theinternal strut elements2080 ofproximal-most cell structure2027 is also enhanced so as to resist buckling of these elements while the expandable member is being pushed through a sheath or delivery catheter. In one exemplary embodiment, the “as-cut” nominal widths of theenhanced strut elements2016 and2080 are about 0.0045 inches, while the “as-cut” nominal width of the other strut elements are about 0.003 inches.
• FIGS. 24A and 24B illustrate avascular treatment device3000 of another embodiment of the present invention.FIG. 24A depictsdevice3000 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 24B depicts the device in its manufactured and/or expanded tubular configuration. The overall design ofdevice3000 is similar to the design ofdevice2000 depicted and described above in reference toFIG. 23. The primary difference between the two designs lays in the length “L” to width “W” ratio of thecell structures2026,2027,2028,2029 and2030. The length to width ratios of the cells structures ofFIG. 24A are generally greater than the length to width ratios of the respective cell structures ofFIG. 23. As illustrated, the lengths “L” of the cell structures of the device ofFIG. 24A, in the “as-cut” configuration are generally greater than the lengths of the respective cell structures ofFIG. 23, while the widths “W” of the cell structures of the device ofFIG. 24A are generally smaller than the width of the respective cell structures ofFIG. 23. As a result, the slope of theindividual strut elements2040 in the cell structures ofFIG. 24A are generally smaller than the slopes of the respective strut elements in the cell structures ofFIG. 23. By reducing the slope of thestrut elements2040 and leaving the other dimensional and material characteristics constant, the effective radial force along the length of thestruts2040 is reduced. The effect of such a reduction is that the summation of axial force components along lines A-A of the device ofFIG. 24 more closely matches the summation of the radial force components along lines B-B as compared to the device ofFIG. 23. Through experimentation, the inventors have discovered that an “as-cut” cell structure length to width ratio of greater than about 2.0, and an “expanded” cell structure length to width ratio of a greater than about 1.25, advantageously resulted in a longitudinal radial force distribution along the length of theexpandable member2012 that enhanced the expandable member's ability to be pushed through and withdrawn into a lumen of a delivery catheter.
• FIGS. 26, 27A and 27B illustrate anexpandable member5000 in another implementation.Expandable member5000 includes a plurality of generally longitudinalundulating elements5024 with adjacent undulating elements being out-of-phase with one another and connected in a manner to form a plurality of diagonally disposedcell structures5026 angularly disposed between about 40.0 to about 50.0 degrees with respect to one another. In one implementation, the cell structures are diagonally displaced along about a 45.0 degree line. Theexpandable member5000 includes aproximal end portion5014, a cylindricalmain body portion5016 and adistal end portion5018 with thecell structures5026 in themain body portion5016 extending continuously and circumferentially around a longitudinal axis of theexpandable member5000. Thecell structures5026 in theproximal end portion5014 anddistal end portion5018 extend less than circumferentially around the longitudinal axis of theexpandable member5000. In one implementation, the expandable member has an unexpanded or crimped nominal diameter of about 1.0 millimeters and a designed maximum implantable diameter of about 4.0 millimeters.
• In one embodiment,expandable member5000 has an overall length dimension A of about 36.0±2.0 millimeters with themain body portion5016 having a length P of about 19.0±2.0 millimeters. In one implementation the strut width dimension N and thickness dimension O within themain body portion5016 are about 0.0021±0.0004 inches and about 0.0032±0.0005 inches, respectively, while the strut width dimension L of theproximal rails5030 is about 0.0039±0.004 inches.
• In use,expandable member5000 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state (not shown) of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the first nominal diameter (e.g., average diameter of main body portion5016) ranges between about 0.017 to about 0.030 inches, whereas the second nominal diameter (e.g., average diameter of main body portion5016) is between about 2.5 to about 5.0 millimeters. In one implementation, the dimensional and material characteristics of thecell structures5026 residing in themain body portion5016 of theexpandable material5000 are selected to produce sufficient radial force and contact interaction to cause thecell structures5026 to engage with an embolic obstruction residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient. In other embodiments the dimensional and material characteristics of thecell structures5026 in themain body portion5016 are selected to produce a radial force per unit length of between about 0.005 N/mm to about 0.050 N/mm, preferable between about 0.010 N/mm to about 0.050 N/mm, and more preferably between about 0.030 N/mm and about 0.050 N/mm. In one embodiment, the diameter of themain body portion5016 in a designed fully expanded implanted state is about 4.0 millimeters with the cell pattern, strut dimensions and material being selected to produce a radial force of between about 0.030 N/mm to about 0.050 N/mm when the diameter of the main body portion is reduced to 1.5 millimeters. In the same or alternative embodiment, the cell pattern, strut dimensions and material(s) are selected to produce a radial force of between about 0.010 N/mm to about 0.020 N/mm when the diameter of the main body portion is reduced to 3.0 millimeters.
• In one implementation, as shown in the graph ofFIG. 29, the cell structures are constructed to have dimensional and material characteristics to create an overall radial force exerted along the length of theexpandable member5000 of between about 1.70N and about 2.50N when theexpandable member5000 is in the compressed or crimped state. About a −1.0N to a about a −1.7N overall reduction in radial force along the length of the expandable member occurs during about an initial 0.50 mm diametric range of expansion from the compressed or crimped state. In a subsequent 0.5 mm diametric range of expansion that follows the initial 0.5 mm of expansion, about a −0.18N to about a −0.19N overall reduction in radial force along the length of the expandable member occurs. Advantageously, theexpandable member5000 exerts a relatively high radial force during its initial expansion to enhance the likelihood that the struts of expandable member engage an obstruction within the duct of a patient upon initial deployment of the device. In addition, the rate at which the radial force diminishes is initially much greater during the initial expansion of the device than during subsequent expansion. In the exemplary embodiment depicted byFIG. 29, the initial rate of reduction in the radial force during about the first 0.5 mm of expansion is about 5.5 to 9.7 times greater than the rate of reduction during the subsequent 0.5 mm of expansion. An advantage of this radial force characteristic is that high radial force values can be achieved during initial deployment of the expandable member to enhance integration of the struts of the expandable member into the duct obstruction with a subsequent large reduction in radial force after the initial expansion, the large reduction facilitating or enhancing the ability of the obstruction to be removed from the duct of the patient without complications and with limited adverse interactions with the duct (e.g., less damage to the duct wall, etc.). Another advantage of the radial force characteristics depicted inFIG. 29 is that during subsequent expansions, the rate of decrease in the over radial force along the length of the expandable member decreases in a linear-like fashion at a much reduced rate providing a level of predictability of the radial force being exerted at the different expandable member diameters. Also, advantageously, the radial force exerted by the expandable member is designed to achieve a non-zero value when the expandable member is at a designed maximum implantable diameter.
• FIG. 30 illustratesclot retrieval devices6000 according to other implementations where, among other features, the strut elements ofrail segments6001 and6002 have varying width dimensions.FIG. 30 depicts a clot retrieval device in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 30 depicts the device in its manufactured (as-cut) configuration. In one implementation,rail segment6001 transitions from a maximum width dimension at or near itsproximal end6014 to a minimum width dimension at or near itsdistal end6015. In a like manner,rail segment6002 transitions from a maximum width dimension at or near itsproximal end6014 to a minimum width dimension at or near itsdistal end6016. As previously discussed, the width dimensions of the rail segments are selected to enhance their ability to distribute forces and to resist buckling when a push force is applied to theproximal end6014 of the vascular treatment device. In some implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 20.0% and about 50.0%. In other implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 25.0% and about 45.0%. In other implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 35.0% and about 45.0%. In an exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0027±0.0004 inches. In another exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0035±0.0004 inches. In another exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0037±0.0004 inches. As discussed above, post-polishing of the devices generally involve an etching process that typically results in a 40% to 50% reduction in the as-cut cross-sectional dimensions.
• AlthoughFIG. 30 represents rail segments devoid of undulations, as previously described herein, it is appreciated that rail segments such as those shown inFIGS. 1A and 4A are also contemplated. Moreover, it is appreciated that other than the rail width characteristics disclosed above, any number of the features and/or characteristics of the vascular treatment devices previously disclosed herein with respect toFIGS. 1 through 29 (e.g., dimensional, spatial, relational, etc.) may be incorporated into aclot retrieval device6000 according toFIG. 30.
• In some implementations the width ofrails6001 and6002 taper along their length (or a portion thereof) in a substantial uniform and diminishing fashion. In some implementations discrete portions of the rails have a substantially uniform width dimension with transitional tapers being used to join rail portions of different widths. In some implementations discrete portions of the rails have a substantially uniform width dimension with stepped transitions between rail portions of different widths. In other implementations two or more of the preceding width transitional methods are utilized. Although not required, it is preferable that the width transitions occur at portions along the rail struts other than at a junction of the struts (e.g., junctions6030).
• In some implementations, as previously described, struts6012 and6013 of the mostproximal cell structure6018 also have an enhanced width dimension that may be equal to or less than the maximum rail width dimension for the purpose of enhancing the pushability of the clot retrieval device as it is advanced through the tortuous anatomy of a patient. In some implementations less than the entire length ofstruts6012 and6013 are provided with an enhanced width dimension. For example, in some implementations an enhanced width portion extends from a proximal most end ofstruts6012 and6013 and terminates a distance prior tojuncture6026. The configuration ofstruts6012 and6013 may also be altered in manners previously disclosed.
• With continued reference toFIG. 30, in exemplary implementations all or portions ofstruts6003 and6004 (and optionally all or the proximal portions ofstruts6005 and6006) have width dimensions between about 0.0045 inches and about 0.0050 inches, all or portions ofstruts6007 and6008 (and optionally all or the distal portions ofstruts6005 and6006) have width dimensions between about 0.0035 inches and about 0.0036 inches, all or portions ofstruts6009 and6010 (and optionally all or the distal portions ofstruts6007 and6008) have width dimensions between about 0.0027 inches and about 0.0035 inches, and with a substantial portion of the strut elements in the remaining portions of the device (portions A, B and C) having width dimensions between about 0.0027 inches and about 0.0034 inches. In one or more of the immediately preceding implementations, the width dimension ofstruts6012 and6013 is between about 0.0033 inches and about 0.0047 inches, and preferably between about 0.0033 inches and about 0.0040 inches. It is to be appreciated that the dimensions disclosed throughout this disclosure relate to exemplary implementations and are also subject to customary manufacturing tolerances. Variations in the dimensions are possible and contemplated.
• Although not required, it is preferable that the width transitions occur at portions along the struts themselves other than at a junction of the struts (e.g.,junctions6030 and6032).
• In one exemplary implementation struts6003-6006 have a width dimension of about 0.0047 inches, struts6007,6008 and a proximal portion ofstrut6010 have a width dimension of about 0.0036 inches, struts6009,6011 and a distal portion ofstrut6010 have a width dimension of about 0.0035 inches, struts6012-6013 have a width dimension of about 0.0036 inches, with all or a substantial portion of the remaining strut elements of the treatment device having a width dimension of about 0.0027 inches.
• Testing has shown the proximal taper region of the treatment devices ofFIG. 30 to possess good force transmission characteristics along with good radial force characteristics that provide good sheathing and re-sheathing of the proximal taper portion into an introducer sheath and/or delivery catheter.
• In another exemplary implementation struts6003-6006 have a width dimension of about 0.0047 inches, struts6007,6008 and a proximal portion ofstrut6010 have a width dimension of about 0.0036 inches, struts6009,6011 and a distal portion ofstrut6010 have a width dimension of about 0.0035 inches, struts6012-6013 have a width dimension of about 0.0036 inches, the remaining strut elements in section A of the clot retrieval device having a width dimension of about 0.0033 inches and the remaining strut elements generally located in sections B and C of the clot retrieval device having a width dimension of about 0.0027 inches. The increased width dimension of the struts in section A advantageously reduces the likelihood of struts buckling within the proximal taper region of the clot retrieval device and also increases the radial strength of the proximal taper region.
• In another exemplary implementation struts6003-6006 have a width dimension of about 0.0047 inches, struts6007,6008 and a proximal portion ofstrut6010 have a width dimension of about 0.0036 inches, struts6009,6011 and a distal portion ofstrut6010 have a width dimension of about 0.0035 inches, the remaining strut elements in section D of the treatment device having a width dimension of about 0.0033 inches and the remaining strut elements of sections B and C of the treatment device having a width dimension of about 0.0027 inches. The increased width dimension of the struts in section A advantageously reduces the likelihood of struts buckling within the proximal taper region of the clot retrieval device during its delivery to a treatment site of a patient and also increases the radial strength of the proximal taper region.
• In another exemplary implementation struts6003-6006 have a width dimension of about 0.0047 inches, struts6007,6008 and a proximal portion ofstrut6010 have a width dimension of about 0.0036 inches, struts6009,6011 and a distal portion ofstrut6010 have a width dimension of about 0.0035 inches, struts6012-6013 have a width dimension of about 0.0036 inches, the strut elements generally located in section C of the clot retrieval device having a width dimension of about 0.0033 inches, and the remaining strut elements of sections A and B of the clot retrieval device having a width dimension of about 0.0027 inches. The increased width dimension of the struts in section C advantageously reduces the likelihood of struts buckling within the distal taper region of the clot retrieval device during its delivery to a treatment site of a patient. The increased width dimension also increases the radial strength of the proximal taper region that enhances the ability of the distal taper region to remain open while the clot retrieval device is withdrawn from a patient. This feature is particularly advantageous when the clot retrieval device is used for clot removal in that it enables the distal taper section to remain open and sweep away remaining portions of the clot when the clot retrieval device is being withdrawn from the patient.
• According to some implementations theclot retrieval devices6000 according toFIG. 30 are laser cut from a tube having an inner diameter of about 2.667 millimeters and a wall thickness of between about 0.102 millimeters to about 0.126 millimeters. In use, aclot retrieval device6000 according to an implementation of that shown inFIG. 30 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the second nominal diameter (e.g., average diameter of main body portion) is about 4.0±0.5 millimeters. In some implementation, the dimensional and material characteristics of thecell structures6020 generally residing in the main body (section B) of the expandable material are selected to produce sufficient radial force and contact interaction to cause thecell structures6020 to engage with an embolic obstruction/clot residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient.
• In some implementations the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force per unit length of between about 0.030 N/mm to about 0.055 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.035 N/mm to about 0.050 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.037 N/mm to about 0.049 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. Among the same or alternative implementations, the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force of between about 0.010 N/mm to about 0.020 N/mm when the nominal diameter of the main body portion is about 3.0±0.5 millimeters.
• In the implementations ofFIG. 30, many of the cell structures (excluding those that are formed at least in part byrail segments6001 and6002) are shown having similar shapes with most of the cell structure including a pair ofshort struts6022 and a pair oflong struts6023. According to some implementations the area of the cells are about 4.00±0.5 mm². In an exemplary implementation the cell areas are about 4.2 mm². In exemplary implementations,short struts6022 have a length of between about 0.080 and about 0.100 inches,long struts6023 have a length of between about 0.130 and about 0.140 inches to produce a staggered cell arrangement about the circumference of the treatment device. In some implementations the overall length of the expandable portion of the clot retrieval device is between about 35.0 to about 45.0 millimeters with the main body portion (section B) having a length of about 20.0 to about 25.0 millimeters. In one exemplary embodiment the overall length of the expandable portion of the clot retrieval device is about 42.7 millimeters with the main body portion (section B) having a length of about 21.7 millimeters and the proximal and distal taper regions having a length of about 12.4 millimeters and about 8.6 millimeters, respectively.
• FIG. 31 illustratesclot retrieval devices6050 according to other implementations where, among other features, the strut elements ofrail segments6051 and6052 have varying width dimensions.Clot retrieval device6050 is particularly adapted for the treatment of small diameter vessels/duct. In one implementation, as shown inFIG. 31, the circumference of the main body portion (section A) comprises threecell structures6080, but is not limited to such a construction.FIG. 31 depicts the clotretrieval treatment device6050 in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 31 depicts the device in its manufactured (as-cut) configuration. In one implementation,rail segment6051 transitions from a maximum width dimension at or near itsproximal end6053 to a minimum width dimension at or near itsdistal end6054. In a like manner,rail segment6052 transitions from a maximum width dimension at or near itsproximal end6053 to a minimum width dimension at or near itsdistal end6055. As previously discussed, the width dimensions of the rail segments are selected to enhance their ability to distribute forces and to resist buckling when a push force is applied to theproximal end6053 of the vascular treatment device. In some implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 20.0% and about 30.0%, and preferably between about 20% and about 25%. In an exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0036±0.0004 inches.
• AlthoughFIG. 31 representsrail segments6051 and6052 that are devoid of undulations, as previously described herein, it is appreciated that rail segments such as those shown inFIGS. 1A and 4A are also contemplated. Moreover, it is appreciated that other than the rail width characteristics disclosed above, any number of the features and/or characteristics of the treatment devices previously described herein with respect toFIGS. 1 through 29 (e.g., dimensional, spatial, relational, etc.) may be incorporated into aclot retrieval device6050 according toFIG. 31.
• In some implementations the width ofrail6051 and6052 taper along their length (or a portion thereof) in a substantial uniform and diminishing fashion. In some implementations discrete portions of the rails have a substantially uniform width dimension with only transitional tapers being used to join rail portions of different widths. In some implementations discrete portions of the rails have a substantially uniform width dimension with stepped transitions between rail portions of different widths. In other implementations two or more of the preceding width transitional methods are utilized. Although not required, it is preferable that the width transitions occur at portions along the rail struts other than strut junctions (e.g., junctions6064).
• In some implementations struts6056 and6057 of the most proximal cell structure also have enhanced width dimensions that may be equal to or less than the maximum rail width dimension for the purpose of enhancing the pushability of the clot retrieval device as it is advanced through the tortuous anatomy of a patient. In some implementations less than the entire length ofstruts6056 and6057 are provided with an enhanced width dimension. For example, in some implementations an enhanced width portion extends from a proximal most end ofstruts6056 and6057 and terminates a distance prior tojuncture6058. Moreover, the configuration ofstruts6056 and6057 may also be altered in manners previously disclosed.
• With continued reference toFIG. 31, in exemplaryimplementations rail portions6060 and6061 have width dimensions of about 0.0047 andrail portions6062 and6063 have width dimensions of about 0.0036 inches, with a substantial portion of the strut elements in the remaining portions of thedevice6050 having a width dimension of about 0.0027 inches. In other exemplaryimplementations rail portions6060 and6061 have width dimensions of about 0.0047 andrail portions6062 and6063 have width dimensions of about 0.0036 inches, with the struts in adistal portion6070 of device (illustrated with dashed lines) having a width dimension of about 0.0023 inches and a majority of the remaining struts having a width dimension of about 0.0027 inches. The reduced width dimension ofdistal portion6070 produces a region of lower radial strength that in smaller vessels or ducts minimizes surface interactions between thedistal portion6070 and the vessel/duct to prevent or minimize the occurrence of damage to the vessel/duct wall while the clot retrieval device is proximally withdrawn from a patient.
• Testing has shown the proximal taper region of theclot retrieval devices6050 to possess good force transmission characteristics along with good radial force characteristics that provide good sheathing and re-sheathing of the proximal taper portion into an introducer sheath and/or delivery catheter.
• According to some implementations theclot retrieval devices6050 according toFIG. 31 are laser cut from a tube having an inner diameter of about 2.130 millimeters and a wall thickness of between about 0.104 millimeters to about 0.128 millimeters. In use, aclot retrieval device6050 according to an implementation of that shown inFIG. 31 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the second nominal diameter (e.g., average diameter of main body portion) is about 3.0±0.5 millimeters. In some implementation, the dimensional and material characteristics of thecell structures6080 residing in the main body portion (section A) are selected to produce sufficient radial force and contact interaction to cause thecell structures6080 to engage with an embolic obstruction residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient.
• In some implementations the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force per unit length of between about 0.015 N/mm to about 0.035 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.017 N/mm to about 0.033 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. Among the same or alternative implementations, the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force of between about 0.010 N/mm to about 0.020 N/mm when the nominal diameter of the main body portion is about 2.0±0.5 millimeters.
• In the implementations ofFIG. 31, many of the cell structures (excluding those that are formed at least in part byrail segments6051 and6052) are shown having similar shapes with most of the cell structure including a pair ofshort struts6081 and a pair oflong struts6082 that are joined byconnector regions6083. In exemplary implementations (as shown inFIGS. 32A-C),short struts6081 have a linear length, L₁, of about 0.055±0.010 inches,long struts6082 have a linear length, L₃, of about 0.128±0.010 inches andconnector regions6083 have a linear length, L₃, of about 0.0371±0.010 inches. In one or more implementations thecell structures6080 have an area of about 4.5 mm²to about 5.5 mm². In one exemplary implementation thecell structures6080 have an area of about 5.0 mm². In exemplary implementations the overall length of the expandable portion of the clot retrieval device is between about 25.0 millimeters and about 35.0 millimeters with the main body portion (section A) having a length of between about 10.0 millimeters and about 15.0 millimeters. In one exemplary implementation the overall length of the expandable portion of the clot retrieval device is about 30.7 millimeters with the main body portion (section A) having a length of about 13.1 millimeters and the proximal and distal taper regions having a length of about 10.9 millimeters and about 6.7 millimeters, respectively.
• Turning now toFIG. 33A, an alternative implementation to the clot retrieval devices described above in conjunction withFIG. 30 is depicted.FIGS. 33B and 33C illustrate exemplary three-dimensional top and side views of theclot retrieval devices7000 ofFIG. 33A. Sections of thetreatment device7000 that are generally identified as regions E and G are in many respects similar, and in some instances the same, to the same general regions of theclot retrieval devices6000 described above. As an example, the width dimension of the struts generally located in region G may in different implementations take different values to establish any of a variety of desired distal taper characteristics as disclosed above. In addition, region E may assume any of a variety of implementations as previously disclosed above in conjunction with the retrieval devices ofFIG. 30. As shown inFIG. 33A, the sizes of thecell structures7002 generally located in a central region F of thedevice7000 are larger than those in the implementations ofdevices6000 described above. An advantage of the decreased strut density in the central region F ofdevice7000 is that it enhances the integration of an embolic obstruction/clot within region F of the device. In thetreatment devices7000 ofFIGS. 33, the larger cell structures are created by the omission of selectedlong struts6022 in thedevice6000 ofFIG. 30 to createcell structures7002 having areas that are about double the size ofcells7024. In one implementation,cell structures7020 have an area of between about 8.0 mm²and about 8.5 mm². In one exemplaryimplementation cell structures7020 have an area of about 8.3 mm². It is important to note that any of a number of other methods may be used to create the larger cell structures. A particular advantage of the implementations ofFIGS. 33 is that good strut nesting characteristics are preserved to facilitate a low profile delivery state of thedevice7000.
• A decrease in the strut density in a region generally results in a lower radial strength within the region. In a clot retrieval device this reduction can adversely affect the device's ability to integrate with an embolic obstruction/clot. To compensate for this reduction in radial strength, in some implementations selective strut portions7006 (denoted by dashed lines) generally located within region F of the retrieval devices are provided with a width dimension greater than the width dimension of strut portions7004 (denoted by solid lines). In accordance with some implementations the width dimensions ofstrut portions7006 are selected so that the over-all radial strength per unit length of expandable portion of the retrieval device is similar to that absent the removal of struts to create the larger sized cell structures. As an example, in the implementations described above where decreased strut density is achieved by the omission of certainlong struts6022 in a device ofFIG. 30, the width ofstruts7006 are selected so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to that ofdevices6000 described above. For example, in some implementations strutportions7004 have a width dimension of about 0.0027 inches withstrut portions7006 having a width dimension of about 0.0035 inches so that the over-all radial strength per unit length of the expandable portion is similar to the same area of theretrieval devices6000 having mostly unitary cell sizes and strut width dimensions of about 0.0027 inches.
• Although not required, as illustrated inFIG. 33A, the transition of strut widths preferably occur at locations (denoted by “x”) other thanjunctions7008. Although not required, the width transitions preferably comprise tapers that provide a relatively smooth transition between the different width dimensions.
• Strut portions of enhancedwidth7006 are one method of creating a desired over-all radial strength per unit length. Other methods are also available. For example, strutportions7006 may instead have an enhanced thickness dimension overstrut portions7004, or may have a combination of enhanced thickness and width dimensions. In other implementations the width dimension of a majority, substantially all or all of the struts generally located in section F are enhanced to compensate for the reduction in strut density.
• With reference toFIG. 34A, alternative implementations to the clot retrieval devices described above in conjunction withFIG. 30 are depicted.FIGS. 34B and 34C illustrate exemplary three-dimensional top and side views of theclot retrieval devices7020 ofFIG. 34A. Sections of thetreatment device7020 that are generally identified as regions E and G are in many respects similar, and in some instances the same, to the same general regions of theclot retrieval devices6000 described above. As an example, the width dimension of the struts in region G may, in different implementations, take different values to establish any of a variety of desired distal taper characteristics as disclosed above. In addition, region E may assume any of a variety of implementations as previously disclosed above in conjunction with the retrieval devices ofFIG. 30. As shown inFIG. 34A, the sizes of some of thecell structures7022 in a central region J of thedevice7020 are larger than those in the implementations ofdevices6000 described above to provide circumferentially extending zones of decreased strut density that are generally separated by circumferentially extending rows ofnon-enlarged cell structures7024. In thetreatment devices7020 ofFIGS. 34, the larger cell structures are created by the omission of selectedlong struts6022 in thedevice6000 ofFIG. 30 to createcell structures7022 having areas of about double in size. In oneimplementation cell structures7022 have an area of about 8.3 mm². It is important to note that any of a number of other methods may be used to create the larger cell structures. A particular advantage of the implementations ofFIGS. 34 is that good strut nesting characteristics are preserved to facilitate a low profile delivery state of thedevice7020.
• As discussed above, a decrease in the strut density in a region generally results in a lower radial strength within the region. In a clot retrieval device this reduction can adversely affect the device's ability to integrate with an embolic obstruction/clot. To compensate for this reduction in radial strength, selective strut portions7026 (denoted by dashed lines) generally located within region J of the retrieval devices are provided with a width dimension greater than the width dimension of strut portions7025 (denoted by solid lines). In accordance with some implementations the width dimensions ofstrut portions7026 are selected so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to that absent the removal of struts to create the larger sized cell structures. As an example, in the implementations described above where decreased strut density is achieved by the omission of certainlong struts6022 in a device ofFIG. 30, the width ofstruts7026 are selected so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to that ofdevices6000 described above. For example, in some implementations strutportions7025 have a width dimension of about 0.0027 inches withstrut portions7026 having a width dimension of about 0.0035 inches so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to the same area of theretrieval devices6000 having mostly unitary cell sizes and strut width dimensions of about 0.0027 inches. In some implementation the width of thestruts7029 have a width dimension of between 0.0031 inches and about 0.0033 inches similar to those previously discussed above with respect to some implementations ofdevice6000.
• In some implementations, as illustrated inFIG. 34A, the transition of some or all of the strut widths occur at locations other thanjunctions7028, while in other implementations the transition of some or all of the strut widths occur at locations other thanjunctions7028. Although not required, the width transitions preferably comprise tapers that provide a relatively smooth transition between the different width dimensions.
• Strut portions of enhancedwidth7026 are one method of creating in region J a desired over-all radial strength. Other methods are also available. For example, strutportions7026 may instead have an enhanced thickness dimension overstrut portions7025, or may have a combination of enhanced thickness and width dimensions.
• With reference toFIG. 35A, an alternative implementation to the clot retrieval devices described above in conjunction withFIG. 30 is depicted.FIGS. 35B and 35C illustrate exemplary three-dimensional top and side views of theclot retrieval devices7050 ofFIG. 35A. Sections of thetreatment device7050 that are generally identified as regions E and G are in many respects similar, and in some instances the same, to the same general regions of theclot retrieval devices6000 described above. As an example, the width dimension of the struts generally located in region G may in different implementations take different values to establish any of a variety of desired distal taper characteristics as disclosed above. In addition, region E may assume any of a variety of implementations as previously disclosed above in conjunction with the retrieval devices ofFIG. 30. As shown inFIG. 35A, the sizes of some of thecell structures7052 in a central region K of thedevice7050 are larger than those in the implementations ofdevices6000 described above to provide zones of decreased strut density that are dispersed amongnon-enlarged cell structures7054. In thetreatment devices7050 ofFIGS. 35, the larger cell structures are created by the omission of selectedlong struts6022 in thedevice6000 ofFIG. 30 to createcell structures7052 having areas of about double the size ofcells7054. In one implementation the area ofcell structures7052 is about 8.3 mm². It is important to note that any of a number of other methods may be used to create the larger cell structures. A particular advantage of the implementations ofFIGS. 35 is that good strut nesting characteristics are preserved to facilitate a low profile delivery state of thedevice7050.
• As discussed above, a decrease in the strut density in a region generally results in a lower radial strength within the region. In a clot retrieval device this reduction can adversely affect the device's ability to integrate with an embolic obstruction/clot. To compensate for this reduction in radial strength, selective strut portions7056 (denoted by dashed lines) generally located within region K of the retrieval devices are provided with a width dimension greater than the width dimension of strut portions7055 (denoted by solid lines). In accordance with some implementations the width dimensions ofstrut portions7056 are selected so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to that absent the removal of struts to create the larger sized cell structures. As an example, in the implementations described above where decreased strut density is achieved by the omission of certainlong struts6022 in a device of
• FIG. 30, the width ofstruts7056 are selected so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to that ofdevices6000 described above. For example, in some implementations strutportions7055 have a width dimension of about 0.0027 inches withstrut portions7056 having a width dimension of about 0.0035 inches so that the over-all radial strength per unit length of the expandable portion of the retrieval device is similar to the same area of theretrieval devices6000 having mostly unitary cell sizes and strut width dimensions of about 0.0027 inches. In some implementations the width of thestruts7059 have a width dimension of between 0.0031 inches and about 0.0033 inches similar to those previously discussed above with respect to some implementations ofdevice6000.
• Although not required, as illustrated inFIG. 35A, the transition of strut widths preferably occur at locations other thanjunctions7058. Although not required, the width transitions preferably comprise tapers that provide a relatively smooth transition between the different width dimensions.
• Strut portions of enhancedwidth7056 are one method of creating a desired over-all radial strength per unit length. Other methods are also available. For example, strutportions7056 may instead have an enhanced thickness dimension overstrut portions7055, or may have a combination of enhanced thickness and width dimensions.
• FIG. 36 illustratesclot retrieval devices6090 similar to those ofFIG. 30, with a difference in the size of thecell structures6091 generally located in region B of the device. As illustrated inFIG. 36,cell structures6091 are of a greater size than thecell structures6020 of the device shown inFIG. 30. As previously discussed, an advantage of larger sized cell structures within the main body portion of the retrieval device is that it enhances clot integration into the main body portion when a radial strength of the main body portion is properly provided. For the purpose of providing sufficient radial strength in region B of thedevice6090, the struts6092 (denoted by dashed lines) generally located within region B have an enhanced width dimension, which in one implementation is about 0.0035 inches. In one implementation the width dimension of thestruts6092 generally located in region B are similar to or the same as the width dimension of the distal sections ofrail segments6001 and/or6002 (e.g., having the same or similar width dimension of one or more ofstruts6009,6010 and6011). Although not required, the transition in width dimensions preferably occur at locations other than atjunctions6045, as illustrated inFIG. 36.
• FIG. 37 illustratesclot retrieval devices8000 according to other implementations where, among other features, the strut elements ofrail segments8001 and8002 have varying width dimensions.FIG. 37 depicts a clot retrieval device in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 37 depicts the device in its manufactured (as-cut) configuration. In one implementation,rail segment8001 transitions from a maximum width dimension at or near itsproximal end8014 to a minimum width dimension at or near itsdistal end8015. In a like manner,rail segment8002 transitions from a maximum width dimension at or near itsproximal end8014 to a minimum width dimension at or near its distal end8016. As previously discussed, the width dimensions of the rail segments are selected to enhance their ability to distribute forces and to resist buckling when a push force is applied to theproximal end8014 of the clot retrieval device. In some implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 20.0% and about 35.0%. In other implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 25.0% and about 30.0%. In an exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0027±0.0004 inches. In another exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0034±0.0004 inches.
• AlthoughFIG. 37 represents rail segments that are devoid of undulations, as previously described herein, it is appreciated that rail segments such as those shown inFIGS. 1A and 4A are also contemplated. Like the devices ofFIG. 30 disclosed above, it is appreciated that other than the rail width characteristics disclosed in the preceding paragraph, any of a number of the features and/or characteristics of the vascular treatment devices described in conjunction with the devices ofFIGS. 1-29 (e.g., dimensional, spatial, relational, etc.) may be incorporated into aclot retrieval device8000 according toFIG. 37.
• In some implementations the width ofrails8001 and8002 taper along their length (or a portion thereof) in a substantial uniform and diminishing fashion. In some implementations discrete portions of the rails have a substantially uniform width dimension with only transitional tapers being used to join rail portions of different widths. In some implementations discrete portions of the rails have a substantially uniform width dimension with stepped transitions between rail portions of different widths. In other implementations two or more of the preceding width transitional methods are utilized. Although not required, it is preferable that the width transitions occur at portions along the rail struts other than at a junction of the struts (e.g., junctions8030).
• In some implementations, as previously described, struts8012 and8013 of the mostproximal cell structure8018 also have an enhanced width dimension that may be equal to or less than the maximum rail width dimension for the purpose of enhancing the pushability of the clot retrieval device as it is advanced through the tortuous anatomy of a patient. In some implementations less than the entire length ofstruts8012 and8013 are provided with an enhanced width dimension. For example, in some implementations an enhanced width portion extends from a proximal most end ofstruts8012 and8013 and terminates a distance prior to their juncture. The configuration ofstruts8012 and8013 may also be altered in manners previously disclosed.
• With continued reference toFIG. 37, in exemplary implementations all or portions ofstruts8003 and8004 (and optionally all or portions ofstruts8005 and8006) have width dimensions of about 0.0045 inches to about 0.0050 inches, all or portions ofstruts8007 and8008 (and optionally all or portions ofstruts8005 and8006) have width dimensions of about 0.0036 inches to about 0.0040 inches, all or portions ofstruts8009 and8010 (and optionally all or portions ofstruts8007 and8008) have width dimensions of about 0.0034 inches to about 0.0036 inches. In some implementations the remainder of the struts generally located in region M of the device have width dimensions of about 0.0027 inches, the struts in region N have width dimensions of about 0.0034 inches to about 0.0036 inches, and the struts generally located in region O have a width dimension of about 0.0031 inches to about 0.033 inches. In one or more of the immediately preceding implementations, the width dimension ofstruts8012 and8013 is between about 0.0036 inches and about 0.0047 inches. It is to be appreciated that the dimensions disclosed relate to exemplary implementations and are also subject to customary manufacturing tolerances. Variations in the dimensions are also possible and contemplated.
• Although not required, it is preferable that the width transitions occur at portions along the struts themselves other than at a junction of the struts (e.g.,junctions8030 and8032).
• As illustrated inFIG. 37, the strut density in the region generally identified by “N” is notably less than the strut densities in the regions generally identified by “M” and “O”. As a consequence, thecell structures8020 generally located in region N are of a larger size than thecell structures8021 generally located in regions N and O. As previously discussed, an advantage of larger sized cell structures within the main body portion of the retrieval device is that it enhances clot integration into the main body portion (region N) when a radial strength of the main body portion is properly provided. For the purpose of providing sufficient radial strength in region N of the device, the struts within region have an enhanced width dimension as compared to the cell struts generally residing in region M (other than the struts8003-8013) and the cell struts generally residing in region O. In one implementation the width dimension of the struts in region N are similar to or the same as the width dimension of thedistal struts8009,8010 and/or8011 ofrail segments8001 and/or8002.
• In an exemplary implementation struts8003-8006 have a width dimension of about 0.0047 inches, struts8007,8008, and a proximal portion ofstrut8010 have a width dimension of about 0.0040 inches, struts8009,8011 and a distal portion ofstrut8010 have a width dimension of about 0.0034 inches, struts8012-8013 have a width dimension of about 0.0040 inches. In some implementations the remainder of the struts in region M of the device have width dimensions of about 0.0027 inches, the struts in region N have width dimensions of about 0.0034 inches, and the struts in region O have a width dimension of about 0.0031 inches. The increased width dimension of the struts in section O advantageously reduces the likelihood of struts buckling within the distal taper region of the clot retrieval device during its delivery to a treatment site of a patient. The increased width dimension also increases the radial strength of the distal taper region that enhances the ability of the distal taper region to remain open while the clot retrieval device is withdrawn from a patient so that it may sweep away remaining portions of the clot when the clot retrieval device is being withdrawn from the patient.
• According to some implementations theclot retrieval devices8000 according toFIG. 37 are laser cut from a tube having an inner diameter of about 3.77 millimeters and a wall thickness of between about 0.097 millimeters to about 0.131 millimeters. In use, aclot retrieval device8000 according to an implementation of that shown inFIG. 37 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the second nominal diameter (e.g., average diameter of main body portion) is about 5.5±0.5 millimeters. In some implementation, the dimensional and material characteristics of thecell structures8020 residing in the main body (section N) are selected to produce sufficient radial force and contact interaction to cause thecell structures8020 to engage with an embolic obstruction/clot residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient.
• In some implementations the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force per unit length of between about 0.040 N/mm to about 0.065 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.045 N/mm to about 0.060 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.050 N/mm to about 0.060 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. In some implementations the dimensional and material characteristics of the elements along the expandable length are selected to produce a radial force per unit length of between about 0.049 N/mm to about 0.057 N/mm when the outer diameter of the retrieval device is restrained to 1.5 millimeters. Among the same or alternative implementations, the dimensional and material characteristics of the elements along the expandable length of the retrieval device are selected to produce a radial force of between about 0.010 N/mm to about 0.020 N/mm when the nominal diameter of the main body portion is about 4.5±0.5 millimeters.
• In the implementations ofFIG. 37, the cell structures in regions M and0 (excluding those that are formed at least in part byrail segments8001 and8002) are shown having similar shapes with thecell structures8021 including a pair ofshort struts8022 and a pair oflong struts8024. In exemplary implementations the area ofcell structures8021 is between about 4.5 mm²and about 5.5 mm². In one exemplary implementation the area ofcell structures8021 is about 5.0 mm²to about 5.2 mm². Thecell structures8020 generally located in region N, in one implementation, comprise a shape consisting of twoadjoining cell structures8021 with along strut8024 being omitted between them. Although other types of large sized cell structures are contemplated, an advantage of the cell construction illustrated inFIG. 37 is that it possesses good nesting capability to permit the retrieval device to achieve a small delivery profile.
• In some implementations the overall length of the expandable portion of the clot retrieval device is between about 55.0 millimeters and about 65.0 millimeters with the main body portion (section N) having a length of between about 25 millimeters and about 35.0 millimeters and the proximal and distal taper regions having a length of between about 10.0 to about 20.0 millimeters. In one exemplary embodiment the overall length of the expandable portion of the clot retrieval device is about 58.4 millimeters with the main body portion (section N) having a length of about 29.3 millimeters and the proximal and distal taper regions having a length of about 16.6 millimeters and 12.5 millimeters, respectively.
• FIG. 38 illustrates clot retrieval devices8500 according to other implementations where, among other features, the strut elements ofrail segments8051 and8052 have varying width dimensions.FIG. 38 depicts a clot retrieval device in a two-dimensional plane view as if the device were cut and laid flat on a surface.FIG. 38 depicts the device in its manufactured (as-cut) configuration. In one implementation,rail segment8051 transitions from a maximum width dimension at or near itsproximal end8066 to a minimum width dimension at or near itsdistal end8067. In a like manner,rail segment8052 transitions from a maximum width dimension at or near itsproximal end8066 to a minimum width dimension at or near itsdistal end8068. As previously discussed, the width dimensions of the rail segments are selected to enhance their ability to distribute forces and to resist buckling when a push force is applied to theproximal end8064 of the clot retrieval device. In some implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 20.0% and about 35.0%. In other implementations the percentage change between the maximum rail width dimension and the minimum rail width dimension is between about 22.0% and about 27.0%. In an exemplary implementation the width dimension of the rail segments transitions from a maximum width dimension of about 0.0047±0.0004 inches to a minimum width dimension of about 0.0035 ±0.0004 inches.
• AlthoughFIG. 38 represents rail segments that are devoid of undulations, as previously described herein, it is appreciated that rail segments such as those shown inFIGS. 1A and 4A are also contemplated. Like the devices ofFIG. 30 disclosed above, it is appreciated that other than the rail width characteristics disclosed in the preceding paragraph, any of a number of the features and/or characteristics of the vascular treatment devices described in conjunction with the devices of
• FIGS. 1-29 (e.g., dimensional, spatial, relational, etc.) may be incorporated into aclot retrieval device8050 according toFIG. 38.
• In some implementations the width ofrails8051 and/or8052 taper along their length (or a portion thereof) in a substantial uniform and diminishing fashion. In some implementations discrete portions of the rails have a substantially uniform width dimension with only transitional tapers being used to join rail portions of different widths. In some implementations discrete portions of the rails have a substantially uniform width dimension with stepped transitions between rail portions of different widths. In other implementations two or more of the preceding width transitional methods are utilized. Although not required, it is preferable that the width transitions occur at portions along the rail struts other than at a junction of the struts (e.g., junctions8070).
• In some implementations, in a manner previously described, struts8064 and8065 of the most proximal cell structure also have an enhanced width dimension that may be equal to or less than the maximum rail width dimension for the purpose of enhancing the pushability of the clot retrieval device as it is advanced through the tortuous anatomy of a patient. In some implementations less than the entire length ofstruts8064 and8065 are provided with an enhanced width dimension. For example, in some implementations an enhanced width portion extends from a proximal most end ofstruts8064 and8065 and terminates a distance prior to their juncture. The configuration ofstruts8064 and8065 may also be altered in manners previously disclosed.
• With continued reference toFIG. 38, in exemplary implementations all or portions ofstruts8053 and8054 (and optionally all or portions ofstruts8055 and8056) have width dimensions of about 0.0045 inches to about 0.0050 inches, all or portions ofstruts8057 and8058 (and optionally all or portions ofstruts8055,8056,8059 and8060) have width dimensions of about 0.0036 inches to about 0.0040 inches, all or portions ofstruts8059 and8060 (and optionally all or portions ofstruts8061,8062 and8063) have width dimensions of about 0.0034 inches to about 0.0036 inches. In some implementations the remainder of the struts generally located in region P of the device have width dimensions of about 0.0027 inches, the struts generally located in region Q have width dimensions of about 0.0034 inches to about 0.0036 inches, and the struts generally located in region R have a width dimension of about 0.0031 inches to about 0.033 inches. In one or more of the immediately preceding implementations, the width dimension ofstruts8064 and8065 is between about 0.0036 inches and about 0.0047 inches. It is to be appreciated that the dimensions disclosed relate to exemplary implementations and are also subject to customary manufacturing tolerances. Variations in the dimensions are possible and contemplated.
• Although not required, it is preferable that the width transitions occur at portions along the struts themselves other than at a junction of the struts (e.g.,junctions8070 and8071).
• As illustrated inFIG. 38, the strut density in the region generally identified by “Q” is notably less than the strut densities in the regions generally identified by “P” and “R”. As a consequence, thecell structures8080 generally located in region Q are of a larger size than thecell structures8081 generally located in regions P and R. As previously discussed, an advantage of larger sized cell structures within the main body portion of the retrieval device is that it enhances clot integration into the main body portion (region Q) when a radial strength of the main body portion is properly provided. For the purpose of providing sufficient radial strength in region Q of the device, the struts generally located within region Q have an enhanced width dimension as compared to the cell struts generally located in region P (other than the struts8053-8065) and the cell struts generally located in region R. In one implementation the width dimension of the struts in region Q are similar to or the same as the width dimension of the distal sections ofrails8051 and8052 (e.g., struts8061,8062 and/or8063).
• In an exemplary implementation struts8003-8006 and a proximal portion ofstruts8055 and8056 have a width dimension of about 0.0047 inches, struts8057,8058, and a distal and proximal portions ofstruts8055,8056 and8059,8060, respectively, have a width dimension of about 0.0040 inches, struts8009,8011 and a distal portion ofstrut8010 have a width dimension of about 0.0034 inches, struts8012-8013 have a width dimension of about 0.0040 inches, struts8061,8062,8063 and the distal portions ofstruts8059 and8060 have a width dimension of about 0.0035 inches. In some implementations the remainder of the struts generally located in region P of the device have width dimensions of about 0.0027 inches, the struts generally located in region Q have width dimensions of about 0.0035 inches, and the struts generally located in region R have a width dimension of about 0.0031 inches. The increased width dimension of the struts in section R advantageously reduces the likelihood of struts buckling within the distal taper region of the clot retrieval device during its delivery to a treatment site of a patient. The increased width dimension also increases the radial strength of the distal taper region that enhances the ability of the distal taper region to remain open while the clot retrieval device is withdrawn from a patient so that it may sweep away remaining portions of the clot when the clot retrieval device is being withdrawn from the patient.
• According to some implementations theclot retrieval devices8050 according toFIG. 38 are laser cut from a tube having an inner diameter of about 3.77 millimeters and a wall thickness of between about 0.097 millimeters to about 0.131 millimeters. In use, aclot retrieval device8050 according to an implementation of that shown inFIG. 38 is advanced through the tortuous vascular anatomy or bodily duct of a patient to a treatment site in an unexpanded or compressed state of a first nominal diameter and is movable from the unexpanded state to a radially expanded state of a second nominal diameter greater than the first nominal diameter for deployment at the treatment site. In alternative exemplary embodiments the second nominal diameter (e.g., average diameter of main body portion) is about 6.0±0.5 millimeters. In some implementation, the dimensional and material characteristics of thecell structures8080 residing in the main body (section Q) are selected to produce sufficient radial force and contact interaction to cause thecell structures8080 to engage with an embolic obstruction/clot residing in the vascular in a manner that permits partial or full removal of the embolic obstruction from the patient. In some implementation, the dimensional and material characteristics are selected to produce a radial force per unit length in the expandable portion of the retrieval device of between about 0.010 N/mm to about 0.020 N/mm when the diameter of the main body portion is reduced to about 5.0 ±0.5 millimeters.
• In the implementations ofFIG. 38, the cell structures generally located in regions P and R (excluding those that are formed at least in part byrail segments8051 and8052) are shown having similar shapes with thecell structures8081 including a pair ofshort struts8082 and a pair oflong struts8084. In an exemplary implementation the area ofcell structures8081 is about 9.2 mm². Thecell structures8080 generally located in region Q, in one implementation, comprise a shape consisting of twoadjoining cell structures8081 with along strut8084 being omitted between them. Although other types of large sized cell structures are contemplated, an advantage of the cell construction illustrated inFIG. 38 is that it possesses good nesting capability to permit the retrieval device to achieve a small delivery profile.
• In some implementations the overall length of the expandable portion of the clot retrieval device is between about 65.0 millimeters and about 75.0 millimeters with the main body portion (section Q) having a length of between about 25.0 millimeters and about 35.0 millimeters. In one exemplary implementation the overall length of the expandable portion of the clot retrieval device is about 71.9 millimeters with the main body portion (section Q) having a length of about 32.3 millimeters and the proximal and distal taper regions having a length of about 22.5 millimeters and 17.1 millimeters, respectively.
• FIG. 39 depicts a two dimensional view of a ductobstruction retrieval device370 according to another implementation. As with some of the other implementations previously described, theretrieval device370 comprises a proximaltapered end portion371, a cylindricalmain body portion372 and a distaltapered end portion373. A difference in the distaltapered end portion373 as compared to the distal tapered end portions previously described is that the distaltapered end portion373 has less than three full rows of cell structures so as to reduce the distal taper length. In the example ofFIG. 39 the distal tapered end portion comprises two full rows ofcell structures374 and375 and a partial row ofcell structures376. (For the sake of clarity, althoughrow375 in the implementation ofFIG. 39 includes a single cell structure, it is in any case considered a row of cell structures.) The inclusion of a distal tapered end portion in the retrieval device that culminates into a distal antenna provides a number of advantages over retrieval devices that would otherwise terminate in a blunt end. One advantage is that once the retrieval device has been positioned and expanded in a vessel of a patient the tapered end provides a greater degree of placement adjustment over a retrieval device having a blunt end. Another advantage is that the distal tapered end portion is more atraumatic than a blunt end. The reduced taper length achieved by limiting the construction of the distaltapered end portion373 to less than three full rows of cell structures has been found to advantageously result in a distal taper that is both more stable and more atraumatic than those having a greater number of full rows of cell structures. In retrievers having cell structures of different sizes, like those ofcell structures376 and377, it is preferable that the full rows of cells in the distaltapered end portion373 be comprised of substantially all small-sized cell structures377 like that shown inFIG. 39.
• According to some implementations the length of the distaltapered end portion373 in the as-cut manufactured state is less than about 30% of the length of themain body portion372, and preferably less than about 25% of the length of themain body portion372. In one implementation the lengths of themain body portion372 and the distaltapered end portion373 are about 26 mm and 6 mm, respectively. In another implementation the distaltapered end portion373 has a length of between about 4.5 mm to about 5.0 mm. According to some implementations the combined length of the distaltapered end portion373 and thedistal antenna379 is less than about 10 mm.
• FIG. 40A shows a two dimensional view of a ductobstruction retrieval device380 according to another implementation. Like theretrieval device370 shown inFIG. 39,retriever380 comprises a distal tapered end portion comprising less than three full rows of cell structures.Retriever device380 differs fromretriever370 in that the distal tapered end portion comprises cell structures that are bifurcated into a first set ofcell structures386 and a second set ofcell structures387 with the first cell ofcell structures386 terminating at a firstdistal antenna388 and the second set ofcell structures387 terminating at a seconddistal antenna389.FIG. 40B depicts a three dimensional view ofretrieval device380 with thereference number383 denoting the distal tapered end portion of the device. As shown inFIG. 40B,distal antenna388 anddistal antenna389 are joined to form a retrieval device having a distal tapered end portion with a closed end.
• It is important to note that although theretrieval devices370 and380 have been described as comprising distal antennas, in other implementations like retrieval devices are provided without distal antennas. The same applies to each of the implementations disclosed and contemplated herein. In addition, with reference to theretrieval device380 ofFIG. 40, in another implementation only a single distal antenna is provided that is chosen betweendistal antenna388 anddistal antenna389. In such an implementation the retrieval device would possess an open distal end with the second set ofcell structures387 being available to sweep along the treatment vessel to capture dislodged material.
• FIG. 41 is a two dimensional view of a ductobstruction retrieval device390 according to another implementation that comprises a distal tapered end portion comprising less than three full rows of cell structures. Likeretrieval device380, the distal tapered end portion ofretrieval device390 has cell structures that are bifurcated into a first set ofcell structures396 and a second set ofcell structures397 with the first cell ofcell structures396 terminating at a firstdistal antenna398 and the second set ofcell structures397 terminating at a seconddistal antenna399. As shown inFIG. 41, the first and seconddistal antennas398 and399 are longitudinally off-set from one another. In one implementation a radiopaque material, feature (e.g., flared strut) or component (e.g., a coil) is positioned on each of the first and second antennas. By virtue of there off-set construction, a radiopaque component, for example, on each of the antennas enables the distal end of the retrieval device and the distal tapered end portion of the retrieval device to be visually delineated during the treatment procedure.
• FIG. 42A is a two dimensional view of a ductobstruction retrieval device450 according to another implementation. Theretrieval device450 comprises an expandable member that has a proximaltapered end portion451, a cylindrical main body portion452 and a distaltapered end portion453. The outer-most cell structures in the proximal tapered end portion have outer wall segments that form first andsecond rail segments454 and455, respectively. Each of therail segments454 and455 extend from a proximal-most end of the expandable member to a position at or near the proximal end of the cylindrical main body portion452. In the implementation ofFIG. 42, each of therail segments454 and455 are undulating. Aproximal antenna457 extends proximally from aproximal-most cell structure456.
• Theproximal-most cell structure456, as shown in greater detail inFIG. 42B, comprises first and secondouter struts460 and461, respectively, and first and secondinner struts462 and463, respectively. As shown in the layout ofFIG. 42B, the firstouter strut460 and afirst portion461aof the secondouter strut461 are straight in the two dimensional layout while the firstinner strut462, secondinner strut463 and thesecond portion461bofstrut461 are curvilinear in the two dimensional layout. In the manufactured, three dimensional configuration the firstouter strut460 and thefirst portion461aof the secondouter strut461 are curved and devoid of undulations. As a result of being oriented at the proximal end of the expandable member and being co-extensive to the proximal antenna, the straight strut segments of theproximal-most cell structure456 enhance the pushability of theretrieval device450 as it is delivered through the anatomy of a patient as compared to retrieval devices having proximal-most cell structure with only curved struts in the two dimensional layout.
• In some implementations, the total length ofstruts460 and462 (L1) and the total length ofstruts461 and463 (L2) are substantially the same in order to promote a nesting of the struts when the expandable member transitions from the expanded state to the unexpanded state. According to some implementations the difference in length between L1 and L2 is less than 5.0%, while in other implementations the difference in length between L1 and L2 is less than 1.0%.
• FIG. 43 illustrates a variation of theproximal-most cell structure456. As depicted, each ofstruts460 and461 have an area of reducedwidth464 and465, respectively, that are located adjacent theirjunction466 with theproximal antenna457. The inclusion of the reducedwidth areas464 and465 locally enhances the proximal-most cell structure's ability to collapse by reducing the amount of force needed to initiate and effectuate the collapse. Thus, for example, when theretrieval device450 is first introduced into an introducer sheath for placement within a delivery catheter or is withdrawn into a delivery catheter after the expandable member has deployed inside a patient, the areas of reducedwidth464 and465 cause thestruts460 and461 to be more easily folded in the area of thejunction466 with less force than would otherwise be required absent the areas of reduced width. This makes theretrieval device450 more manageable when being handled by healthcare professionals when theretrieval device450 is being introduced into the delivery catheter for the first time, thus reducing the likelihood of the retrieval device being damaged during the introduction process. As previously discussed, after theretrieval device450 has been introduced and expanded inside the duct of a patient there may be occasions when the retrieval device is proximally withdrawn back into the delivery catheter. This may occur, for example, upon the retrieval device being improperly placed in the duct or upon the completion of a retrieval procedure. In each of these instances because less force is required to collapse the expandable member of the retrieval device several advantages are realized. One advantage is that it reduces the likelihood of theretrieval device450 acting upon the delivery catheter in a manner that would cause an inadvertent displacement of the delivery catheter within the duct of the patient. Another advantage is that it reduces the likelihood of excessive force being applied at the attachment between theproximal antenna457 and the elongate wire (e.g.elongate wire40 shown inFIG. 1A) that would result in a failure at the junction.
• In the implementation ofFIG. 43 the areas of reducedwidth464 and465 comprise tapers. In other implementations the areas of reduced width are denoted by a stepped reduction in strut width. The amount by which the width is reduced inareas464 and465 will vary according to the nominal widths ofstruts460 and461. In any event, it is important that the amount of width reduction is consistent with the radial force and structural integrity requirements of the expandable member. It has been discovered that a reduction of width in the as-cut manufactured state of between about 5.0% and about 20.0% is suitable for struts having a nominal width of between about 0.0057 inches and about 0.0027 inches, with a preferable range being between about 10.0% and about 20.0% in width reduction. In one implementation the width dimension W1 ofstruts460 and461 is about 0.0053 inches with the minimum width dimension of the areas of reduced width being 0.0047 inches. In another implementation the width dimension W1 ofstruts460 and461 is about 0.0057 inches with the minimum width dimension of the areas of reduced width being 0.0046 inches.
• In some implementations the as-cut width dimensions ofstruts460 and461 are different, with the width dimension of their respective areas of reducedwidth464 and465 also being different. For example, in oneimplementation strut460 has a width dimension of about 0.0050 inches,strut461 has a width dimension of about 0.0057 inches, and areas ofreduce width464 and465 have width dimensions of about 0.0042 inches and about 0.0046 inches, respectively.
• FIG. 44 shows another variation of theproximal-most cell structure457 whereinouter struts460 and461 comprise aproximal section467, amidsection468 and adistal section469. Because the width dimensions of theouter struts460 and461 of theproximal-most cell structure456 are generally made greater than most of struts in the remaining portion of theretrieval device450 for the purpose of enhancing the pushability of the expandable member, the bulk of material at thejunctures471 and472 located at the distal end of the struts may impede the expandable member's ability to collapse. For this reason, in the implementation ofFIG. 44 thedistal sections469 have a reduced width dimension in order to reduce the amount of material occupying thejuncture regions471 and472. AlthoughFIG. 44 also shows theproximal sections467 having a reduced width dimension (similar to that described above), in some implementations this is not the case. In a manner described above, the sections of reduced width may comprise tapers and/or steps.
• Another advantage of the implementation depicted inFIG. 44 is that themidsection468 ofstruts460 and461 may be provided with a sufficient width to enhance the visibility of the device under fluoroscopy without materially impacting the ability of the proximal end of the proximaltapered region451 to collapse or to otherwise assume its unexpanded state. According to one implementation the width dimension of the strut midsections468 is about 0.0053 inches and the minimum width dimension of the proximal anddistal sections467 and469 being 0.0047 inches and 0.0041 inches, respectively. As with some of theFIG. 43 implementations, in someFIG. 44 implementations the width dimensions ofstruts460 and461 are different, with the width dimension of one or more of their respective proximal sections, midsections and distal sections being different.
• FIG. 45A is a two dimensional view of a ductobstruction retrieval device800 according to another implementation. Theretrieval device800 comprises an expandable member that has a proximaltapered end portion801, a cylindrical main body portion802 and a distaltapered end portion803. The outer-most cell structures in the proximal tapered end portion have outer wall segments that form on one side anon-undulating rail segment804 and on the other side an undulatingrail segment805. Each of therail segments804 and805 extend from a proximal-most end of the expandable member to a position at or near the proximal end of the cylindrical main body portion802. Aproximal antenna806 extends proximally from aproximal-most cell structure807 while adistal antenna808 extends distally from the distal end of distaltapered section803. The distaltapered section803 is similar to that described above in conjunction withFIG. 39. In some implementations theproximal-most cell structure807 has the same features and characteristics asproximal-most cell structure456 in the implementations ofFIGS. 42-44 above.
• As a result of the diagonal disposition of the cell structures in the retrieval device, the straight line length along which rails804 and805 pass are different in the as-cut manufactured state with the straight line length that passes alongrail804 being longer than the straight line length that passes alongrail805. The linear configuration ofrail804 in combination with the undulating configuration ofrail805 advantageously results in therails804 and805 having lengths that more closely approach one another when the retrieval device assumes it's unexpanded/delivery state. According to one implementation, rails804 and805 are configured to achieve substantially the same length when theretrieval device800 is in the unexpanded/delivery state. In some implementations, the difference in length betweenrails804 and805 is between about 0% to about 5% when theretrieval device800 is in the unexpanded/delivery state.
• As discussed earlier, the retrieval devices disclosed and contemplated herein are generally laser cut from a tube and in their actual three dimension configuration generally comprise tube like structures.FIG. 45, like many of the other figures, represents a retrieval device as it would appear in a two dimension layout, that is, as if it were cut along its length and laid out on a flat surface. With this in mind, and with reference toFIG. 45B, in the two dimension layout the cell structures are polygons comprising a plurality of struts. As shown,rail segments804 and805 are constructed by the outer walls of the outermost cell structures807,810 and811 in the proximaltapered section810. Undulatingrail segment805 is formed by a firstouter wall812 of the proximal-most cell structure and theouter walls814 ofouter cell structures810, whereas thenon-undulating rail segment804 is formed by a secondouter wall813 of the proximal-most cell structure and theouter walls815 ofouter cell structures811. As represented inFIG. 45B, in the two dimension layout theouter walls814 are curvilinear and theouter walls815 are straight. As will be appreciated, when in the tubular form, therail804 will be curved when the expandable member assumes an expanded state, but will nonetheless be devoid of undulations.Rail805 will also assume an additional degree of curvature in its three dimensional state, but unlikerail804 will comprise undulations.
• An advantage of the proximaltapered section801 design is that thenon-undulating rail segment804 provides the aforementioned benefits related to pushability and kink resistance, while the undulatingrail segment805 accommodates the inclusion of a larger number of symmetric-shaped polygons and/or nearly symmetric-shaped polygons within thesection801. The inclusion of an increased number of symmetric-shaped and/or nearly symmetric-shaped polygons in the distaltapered end portion801 improves its ability to assume it's unexpanded or compressed state and also provides for a more uniform and compact configuration. Because symmetrically shaped cell structures have better nesting tendencies than their non-symmetric counter-parts, the aforementioned advantages are achieved, at least in part, by the increased number of symmetrically shaped cell structures disposed within the proximaltapered end portion801.
• Another advantage of a proximal tapered end portion having onenon-undulating rail segment804 and one undulatingrail segment805 is that the inclusion of the undulating rail segment provides more freedom in the design of the cell structures within the proximal tapered end portion as opposed to a design having two non-undulating rails. As shown inFIG. 45B, theouter cell structures811, along which thenon-undulating rail segment804 is formed, comprise structures that are considerably more symmetric than those, like for example, shown inFIG. 30.
• With reference toFIG. 45C, according to one implementation theretriever device800 has the following as-cut dimensional characteristics: L1=56.44 mm±0.50 mm; L2=26.85 mm±0.50 mm; L3=2.0 mm±0.1 mm; L4=4.0 mm±0.3 mm; W1=0.0054 inches±0.0004 inches; W2=0.0056 inches±0.0004 inches; W3=0.0047 inches±0.0004 inches; W4=0.0047 inches±0.0004 inches; W5=0.0040 inches±0.0004 inches; W6=0.0027 inches±0.0004 inches; W7=0.0034 inches±0.0004 inches; W8=0.0031 inches±0.0004 inches; W9=0.010 inches±0.007 inches; W10=0.0035 inches±0.0004 inches; W11=0.0025 inches±0.0004 inches. In one implementation the length of the proximal tapered end portion and the distal tapered end portion is about 13 mm and 7 mm, respectively.
• FIG. 46 illustrates anobstruction retrieval device830 according to another implementation whereinportions833 of somestruts832 in the distaltapered end portion831 of the retriever device are flared to enhance the radiopacity of the distal region of the device. In some implementations during manufacture each ofportions833 are laser cut so as to possess an enhanced width dimension with respect to the remainder ofstrut832. Besides in themselves enhancing radiopacity, the flared portions (or portions of enhanced width) provide a good platform for receiving a radiopaque coating such as, for example, a gold coating. In the implementation ofFIG. 46 the flared portions88 are positioned a sufficient distance from thestrut junctions834 so as to not interfere with the retriever's ability to compress. In the implementation ofFIG. 46 the flaredportions833 are also longitudinally staggered so that when theretriever830 is in the compressed state no more than a single flaredportion833 will occupy a longitudinal position. Such a configuration lessons the impact the flaredportions833 may have on the retriever's lowest achievable diameter dimension along the distaltapered end portion831. In the embodiment ofFIG. 46, the flared portions comprise nodes which in one implementation have a diameter of about 0.015 inches. In other embodiments the flaredportions833 are longitudinal in nature and occupy a substantial length of thestruts832. In such implementations the flaredportions833 may have a width of between about 0.0035 inches to about 0.0045 inches.
• FIGS. 47A and 47B illustrate a distal segment of anobstruction retrieval device480 according to one implementation.FIG. 47A depicts thedevice480 in a two-dimensional layout as if it were cut along its length and laid out on a flat surface. WhileFIG. 47A depicts thedevice480 in its as-cut configuration, the three-dimensional representation ofFIG. 47B shows thedevice480 in a post-cut manufactured state.
• With reference toFIG. 47A, the distal segment ofdevice480 comprises a plurality of distal cell structures488-491 with a set ofantennas481,482 and483 extending distally from the junction regions492-494 of cell structures488-491. In some implementations tabs485-487, or other enhanced dimension features, are provided at one or more ends of the distal most cell structures for the purpose of identifying the distal end of the device under fluoroscopy by virtue of their enhanced dimensional characteristics and/or as a result of being endowed with a radiopaque material. As shown inFIG. 47A, in some implementations the distal-most cell structures are smaller than the adjacent cell structures in the main body portion of thedevice480.
• As shown inFIG. 47B, at a point in time after thedevice480 has been formed, such as being cut by a laser, the distal ends ofantennas481,482 and483 are joined together at thejuncture484 so as to provide the internal cavity ofdevice480 with a closed-end. In effect, the closed-end forms a basket that facilitates the collection of particulates, such as embolic material, that may become dislodged during a retrieval procedure. In some implementations thejuncture484 is formed by soldering together the distal ends of the antennas481-483. In some implementations the distal ends of the antennas481-483 are positioned within an encasement, such as a coil spring or other perforated structure, with a solder or other bonding agent being applied within and/or about the encasement to effectuate a bonding together of the distal ends of the antennas481-483. In some implementations the encasement comprises a rounded atraumatic distal tip. In some implementations the encasement comprises a radiopaque material.
• FIGS. 48A and 48B illustrate anobstruction retrieval device850 according to one implementation.FIG. 48A depicts thedevice850 in a two-dimensional layout as if it were cut along its length and laid out on a flat surface. WhileFIG. 48A depicts thedevice850 in its as-cut configuration, the three-dimensional representation ofFIG. 48B shows thedevice480 in a post-cut manufactured state. The device includes aproximal antenna851, aproximal taper portion852, amain body portion853 and adistal portion855. In the as-cut manufactured state themain body portion853 and thedistal portion855 have the same, or substantially same, diameter. At a point in time after thedevice850 has been cut, such as by laser cutting, thedevice850 is formed so that the unconstrained configuration of thedistal portion855 has a diameter that is greater than that of the unconstrainedmain body portion853. The post as-cut form of thedevice850 may be achieved with the use of mandrels or other tools and methods known in the art. In some implementation the ratio of the unconstrained diameter of the distal portion855 (absent the transition portion854) and themain body portion853 is between about 1.2/1.0 and about 2.0/1.0. For example, according to one implementation the average unconstrained diameter of themain body portion853 is about 2.0 millimeters and the average unconstrained diameter of thedistal portion855, absent thetransition portion864, is about 4.0 millimeters. According to some implementations the ratio of the unconstrained length of the distal portion855 (absent the transition portion854) and the unconstrained length of the main body portion is between about 0.2 to about 0.7. For example, according to one implementation the unconstrained length of themain body portion855 is between about 15 to 25 millimeters and the unconstrained length of the distal portion (absent the transition portion854) is between about 5 to 10 millimeters.
• According to some implementations, as depicted inFIG. 48A, the cell structures in themain body portion853 are larger in size than those in thedistal portion855. The lower strut density in themain body portion853 facilitates an integration of theretrieval device850 within an obstruction. The higher strut density in thedistal portion855 facilitates the entrapment of dislodge particles as discussed in more detail below. Additionally, in some implementations the retrieval device is constructed in a manner that results in a radial force being exerted by themain body portion853 that is greater than the radial force exerted by thedistal portion855 when theretrieval device850 is deployed within a duct of a patient. In such an implementation, themain body portion853 is situated to capture an obstruction while thedistal portion855 more gently acts against a wall of the duct distal to the obstruction to entrap portions of the obstruction that become dislodged during and after its capture. As such, according to one method theretrieval device850 is placed at the treatment site of a patient by use of a delivery catheter, as previously disclosed herein. Theretrieval device850 is positioned at a distal end of the delivery catheter so that themain body portion853 is positioned at the site of the obstruction to be retrieved. When sheathed within the delivery catheter themain body portion853 and thedistal portion855 have the same, or substantially the same, diameter. Thereafter, the delivery catheter is withdrawn proximally to cause the constrained retrieval device to expand at the treatment site so that themain body portion853 is at least partially forced into the obstruction and so that at least a portion of thedistal portion855 more gently rests against the duct wall distal to the obstruction. Upon the obstruction being captured within themain body portion853 ofdevice850, the device may be removed from the patient in a manner consistent with one or more of the methods previously disclosed herein. During such removal, as the retrieval device is pulled proximally thedistal portion855 sweeps along the duct wall to entrap portions of the obstruction that may have become dislodged. By virtue of its enhanced diametric dimension, thedistal portion855 maintains contact with the duct wall during all or a portion of the removal procedure.
• As discussed above, a lower strut density in themain body portion853 facilitates an integration of theretrieval device850 within an obstruction. However, in some implementations the retrieval device is constructed in a manner that results in a radial force being exerted by themain body portion853 that is greater than the radial force exerted by thedistal portion855 when theretrieval device850 is deployed within a duct of a patient. To achieve this variation in a radial force, in some implementations the width dimension of the struts in themain body portion853 of the retrieval device are cut to have a larger width dimension of at least some or all of the struts in thedistal portion855.
• As shown inFIGS. 48A and 48B, in some implementations the strut density in thedistal segment855 is further enhanced by the inclusion ofnon-linear struts860 in at least some of the cell structures. In some implementations the non-linear struts extend between theproximal end864 anddistal end866 of cell structures. In some implementations thenon-linear struts860 extend between theproximal end864 anddistal end866 of cell structures with thenon-linear strut861 having substantially the same length as theupper strut861 and/orlower strut862 in the as-cut configuration. Such a construction enhances the ability of the cell structure struts to nest resulting in a lower achievable constrained diameter of the retrieval device. In some implementations thenon-linear struts861 extend between theproximal end864 anddistal end866 of cell structures with the upper, lower andnon-linear struts860,862 and861, respectively, having substantially the same length in the as-cut configuration. So as not to greatly impact the radial force produced in thedistal segment855, in some implementations thenon-linear struts860 have a width dimension less than the width dimension of the upper andlower struts861 and862. In some implementations the ratio of the width dimension ofstruts860 and the width dimension of each of the upper andlower struts861 and862, respectively, is between about 0.70 and 0.80. For example, according to one implementation each of the upper and lower struts,361 and362, have a width dimension of about 0.0035 inches whilestrut360 has a width dimension of about 0.0025 inches.
• FIG. 49 illustrates a variation to the as-cut configuration shown inFIG. 48A. As shown inFIG. 49, theretrieval device870 comprises a proximaldistal portion871, amain body portion872 and adistal portion873, the distal portion being shorter in length than that depicted inFIG. 48A.
• FIG. 50 illustrates a distal segment of a retrieval device similar to that shown inFIGS. 47A and 47B having one or more radiopaque wires orribbons495 wound about the struts that form cell structures488-492. Throughout the remainder of the disclosure the term “wire” is used broadly to include wires, ribbons, or like structures. Although the entirety of the cell struts that form cell structures488-492 may be wound with one or moreradiopaque wires495 as shown inFIG. 50, in other implementations only a selected number of struts may possess radiopaque wire windings. An advantage of incorporating the radiopaque wire windings into the distal segment of the retrieval device is that it enhances the visibility of the distal end of the device under fluoroscopy. In addition, when a sufficient number of distal member struts are endowed with wire windings, such as shown inFIG. 50, the wire windings enhance the stiffness of the distal segment. An advantage of increasing the stiffness of the distal segment is that it inhibits prolapse of the distal segment as the retrieval device is advanced through a delivery catheter or treatment duct of a patient. In one implementation the one or more wires comprise platinum. However, it is to be appreciated that any of a number of other radiopaque materials may be used. The one or more wires may comprise a core structure, such as stainless steel, that is clad or otherwise coated with a radiopaque material. The one or more wires may also comprise a polymeric structure impregnated, doped or otherwise coated with a radiopaque material. In some implementations the cross-sectional area of the one or more wires varies to provide a variation in radiopacity and/or stiffness within the distal segment. In some implementations the diameter or width dimension of the one ormore wires495 is in the range of between about 20% to about 50% less than the width dimension of the struts which form the distal segment.
• Although not shown inFIG. 50, in some implementations small recesses are provided in at least some of the struts of cell structures488-492 for the purpose of guiding the placement of the wire windings to designated locations. Preferably, the recesses are sized to receive only a portion of the wire so that only a portion of the wire resides within the recess and a portion of the wire resides outside the recess.
• FIGS. 51A through 51D illustrate other aspects of aclot retrieval device550 which are in some ways similar to theretrieval device850 depicted inFIGS. 48A and 48B.FIGS. 51A-51D depict thedevice550 in a two-dimensional layout as if it were cut along its length and laid out on a flat surface. The device includes aproximal antenna561, aproximal taper portion551, amain body portion552aand adistal portion552b. In the as-cut manufactured state themain body portion552aand thedistal portion552bhave the same, or substantially same, diameter. At a point in time after thedevice550 has been cut, such as by laser cutting, thedevice550 is formed so that the unconstrained configuration of thedistal portion552bhas a diameter that is greater than that of the unconstrainedmain body portion552a. The post as-cut form of thedevice550 may be achieved with the use of mandrels or other tools and methods known in the art. In some implementation the ratio of the unconstrained diameter of thedistal portion552band themain body portion552ais between about 1.2/1.0 and about 2.0/1.0. For example, according to one implementation the average unconstrained diameter of themain body portion552ais about 2.0 millimeters and the average unconstrained diameter of thedistal portion552bis about 4.0 millimeters. According to some implementations the ratio of the unconstrained length of thedistal portion552band the unconstrained length of themain body portion552ais between about 0.2 to about 0.7. For example, according to one implementation the unconstrained length of themain body portion552ais between about 15 to 25 millimeters and the unconstrained length of the distal portion is between about 5 to 10 millimeters.
• According to some implementations, cell structures in theproximal taper portion551, main body portion552 anddistal portion552bare of different sizes. In the example ofFIG. 51A, the cell sizes are multiples of one another withcell structure554 comprising an area approximately equal to two ofcell structure553 andcell structure555 comprising an area approximately equal to three ofcell structures553. It is important to note that cell sizes that are multiples of one another are not required.FIG. 51B illustrates the length dimension L1 and width dimension W1 ofcell structure553.FIG. 51C illustrates the length dimension L2 and width dimension W2 ofcell structure554.FIG. 51D illustrates the length dimension L3 and width dimension W3 ofcell structure555.
• According to someimplementations cell structures553,554 and555 each have an average length to width ratio greater than one when the retrieval device is in an unexpanded state and when the retrieval device is in an expanded state. The ability of thecell structures553,554, and555 to maintain an average length to width ratio of greater than one inhibits the cells from collapsing lengthwise as thedevice550 travels through a delivery catheter or duct of a patient. In other words, the cell structures ofdevice550 are inhibited from collapsing lengthwise on themselves in an accordion like fashion due to their length to width ratios being greater than one.
• Another aspect is reflected in the length L3 of thecell structures555 in thedistal portion552bof the device. Because thedistal portion552bassumes an expanded diameter that is greater than the expanded diameter of the remaining portions of the device, the length dimension L3 is selected to be sufficiently long in comparison to its width dimension W3 so as to ensure that thecell structures555 maintain their length dimension to be greater than their width dimensions when theretrieval device550 transitions from an unexpanded to an expanded state.
• In some implementations the average length to width ratio of the cell structures in thedistal portion552bof the cylindrical main body portion are greater than the average length to width ratio of the cell structures in theproximal portion552aof the cylindrical main body portion, the average length to width ratio of the cell structures in theproximal portion552aof the cylindrical main body portion being greater than the average length to width ratio of the cell structures in theproximal end portion551, and with the average length to width ratio of the cell structures in the proximal end portion being greater than one when the self-expandable member is in the unexpanded and expanded configuration.
• In some implementations theretrieval device550 is constructed in a manner that results in a radial force being exerted by themain body portion552athat is greater than the radial force exerted by thedistal portion552bwhen theretrieval device550 is deployed within a duct of a patient. In such an implementation, themain body portion552ais situated to capture an obstruction while thedistal portion552bmore gently acts against a wall of the duct distal to the obstruction to entrap portions of the obstruction that become dislodged during and after its capture. As such, according to one method theretrieval device550 is placed at the treatment site of a patient by use of a delivery catheter, as previously disclosed herein. Theretrieval device550 is positioned at a distal end of the delivery catheter so that themain body portion552ais positioned at the site of the obstruction to be retrieved. When sheathed within the delivery catheter themain body portion552aand thedistal portion552bhave the same, or substantially the same, diameter. Thereafter, the delivery catheter is withdrawn proximally to cause the constrained retrieval device to expand at the treatment site so that themain body portion552ais at least partially forced into the obstruction and so that at least a portion of thedistal portion552bmore gently rests against the duct wall distal to the obstruction. Upon the obstruction being captured within themain body portion552aofdevice550, the device may be removed from the patient in a manner consistent with one or more of the methods previously disclosed herein. During such removal, as the retrieval device is pulled proximally thedistal portion552bmay sweep along the duct wall to entrap portions of the obstruction that may have become dislodged. By virtue of its enhanced diametric dimension, thedistal portion552bmaintains contact with the duct wall during all or a portion of the removal procedure.
• As discussed above, a lower strut density in themain body portion552a(as compared to the strut density in the proximal taper portion551) facilitates an integration of theretrieval device550 within an obstruction. However, in some implementations the retrieval device is constructed in a manner that results in a radial force being exerted by themain body portion552athat is greater than the radial force exerted by thedistal portion552bwhen theretrieval device550 is deployed within a duct of a patient. To achieve this variation in a radial force, in some implementations the width dimension of the struts in themain body portion552aof the retrieval device are cut to have a larger width dimension of at least some or all of the struts in thedistal portion552b.
• As shown inFIG. 51A, in some implementations the strut density in thedistal segment552bis further enhanced by the inclusion ofnon-linear struts562 in at least some of the cell structures. In some implementations thenon-linear struts562 extend between theproximal end556 anddistal end557 of cell structures. In some implementations the non-linear struts562 (or intermediate struts) extend between theproximal end556 anddistal end557 of cell structures with thenon-linear strut562 having substantially the same length as theupper strut558 and/orlower strut559 in the as-cut configuration. Such a construction enhances the ability of the cell structure struts to nest resulting in a lower achievable constrained diameter of the retrieval device. So as not to greatly impact the radial force produced in thedistal segment552b, in some implementations thenon-linear struts562 have a width dimension less than the width dimension of the upper andlower struts558 and559. In some implementations the ratio of the width dimension ofstruts562 and the width dimension of each of the upper andlower struts558 and559, respectively, is between about 0.70 and 0.90. For example, according to one implementation each of the upper and lower struts,558 and559, have an as-cut width dimension of about 0.0035 inches whilestrut562 has an as-cut width dimension of about 0.0025 inches.
• Although not shown inFIGS. 51A-51D, in some implementations the cell structures in thedistal segment552bhave wire windings selectively woven through their struts in order to endow the distal segment with a desired radiopacity and/or stiffness as discussed above in relation toFIG. 50.
• In some implementation, a plurality ofantennas560a,560band560cextend distally to the distal-most circumferential row of cell structures in thedistal segment552b. In a manner like that disclosed above in conjunction with the device ofFIGS. 47A and 47B, the distal ends ofantennas560a,560band560care joined together so as to provide the internal cavity ofdevice550 with a partially closed-end. In effect, the closed-end forms a basket that facilitates the collection of particulates, such as embolic material, that may become dislodged during a retrieval procedure. In some implementations the juncture ofantennas560a,560band560cis formed by soldering together the distal ends of the antennas. In some implementations the distal ends of the antennas are positioned within an encasement, such as a coil spring or other perforated structure, with a solder or other bonding agent being applied within and/or about the encasement to effectuate a bonding together of the distal ends of the antennas. In some implementations the encasement comprises a rounded atraumatic distal tip. In some implementations the encasement comprises a radiopaque material.
• FIG. 52A illustrates a retrieval device similar to that disclosed inFIGS. 51A-51D. A difference lies in the construction of the non-linear/intermediate struts570 that are disposed in the distalsegment cell structures555. As shown inFIG. 52A, theintermediate strut570 comprises first and secondcurvilinear elements571 and572, respectively, between which are bifurcation struts573aand573b. An advantage of the configuration ofstrut570 is that it provides additional coverage, as compared to strut562, to assist in entrapping embolic debris. In some implementations the non-linear struts extend between theproximal end556 anddistal end557 ofcell structures555. In some implementations thenon-linear strut570 extends between theproximal end556 anddistal end557 of cell structures with the combined length ofelements571,572 and573abeing approximately the same length as theupper strut558 and/or the combined length ofelements571,572 and573bbeing substantially the same length as thelower strut559 in the as-cut configuration. So as not to greatly impact the radial force produced in thedistal segment552b, in some implementations thenon-linear struts570 have a width dimension less than the width dimension of the upper andlower struts558 and559. In some implementations the ratio of the width dimension ofstruts570 and the width dimension of each of the upper andlower struts558 and559, respectively, is between about 0.70 and 0.90. For example, according to one implementation each of the upper and lower struts,558 and559, have an as-cut width dimension of about 0.0035 inches whilestrut360 has an as-cut width dimension of about 0.0025 inches.
• FIG. 52B illustrates a variation to the retrieval device shown inFIG. 52A with differences existing in the size of thecell structures579 in theproximal section575 of the cylindrical body portion and the inclusion ofcell structure577 in thedistal section576 of the cylindrical body portion. As shown inFIG. 52B,cell structures579 are smaller in size to the similarly situated cell structures in the retrieval device ofFIG. 52A as a result of additional struts being added (those depicted by dashed lines) to essentially reduce the size of the cell structures by half. As noted above, another difference lies in the inclusion ofcell structure577 at the distal end of the retrieval device to provide a the device with a substantial uniform circumferential end. In one implementation anintermediate strut578 extends between the opposite ends ofcell structure577 in a manner similar to that described above with respect tointermediate struts562.
• FIG. 53 illustrates aretrieval device580 that comprises different size cell structures along its length, similar to that disclosed above in conjunction with thedevice550 illustrated inFIGS. 51A-51D.FIG. 53 depicts thedevice580 in a two-dimensional layout as if it were cut along its length and laid out on a flat surface. The device includes aproximal antenna581, aproximal taper portion582, amain body portion583 and adistal portion584. In the as-cut manufactured state themain body portion583 and thedistal portion584 have the same, or substantially same, diameter. At a point in time after thedevice580 has been cut, such as by laser cutting, thedevice580 is formed so that the unconstrained configuration of thedistal portion584 has a diameter that is greater than that of the unconstrainedmain body portion583. The post as-cut form of thedevice580 may be achieved with the use of mandrels or other tools and methods known in the art. In some implementation the ratio of the unconstrained diameter of thedistal portion584 and themain body portion583 is between about 1.2/1.0 and about 2.0/1.0. For example, according to one implementation the average unconstrained diameter of themain body portion583 is about 2.0 millimeters and the average unconstrained diameter of thedistal portion584 is about 4.0 millimeters.
• As illustrated inFIG. 53, the cell structures in theproximal taper portion582,main body portion583 anddistal portion584 are of different sizes. In the example ofFIG. 53, the cell sizes are multiples of one another withcell structures586 comprising an area approximately equal to two ofcell structure585 andcell structure587 comprising an area approximately equal to three ofcell structures585. It is important to note that cell sizes that are multiples of one another are not required. As withcell structures553,554 and555 indevice550 described above,cell structures585,586 and587 each have an average length to width ratio greater than one when theretrieval device580 is in an unexpanded state and when theretrieval device580 is in an expanded state. As discussed above, the ability of the cell structures to maintain an average length to width ratio of greater than one inhibits the cells from collapsing lengthwise as the retrieval device travels through a delivery catheter or duct of a patient. In other words, the cell structures ofdevice580 are inhibited from collapsing lengthwise on themselves in an accordion like fashion due to their length to width ratios being greater than one.
• Another aspect is reflected in the length of thecell structures587 in thedistal portion584 of the device. Because thedistal portion584 assumes an expanded diameter that is greater than the expanded diameter of the remaining portions of the device, the length dimension ofcell structure587 is selected to be sufficiently long in comparison to its width dimension so as to ensure that the cell structure maintains its length dimension to be greater than its width dimensions when theretrieval device580 transitions from an unexpanded to an expanded state.
• In some implementations theretrieval device580 is constructed in a manner that results in a radial force being exerted by themain body portion583 that is greater than the radial force exerted by thedistal portion584 when theretrieval device580 is deployed within a duct of a patient. In such an implementation, themain body portion583 is situated to capture an obstruction while thedistal portion584 more gently acts against a wall of the duct distal to the obstruction to entrap portions of the obstruction that become dislodged during and after its capture. As such, according to one method theretrieval device580 is placed at the treatment site of a patient by use of a delivery catheter, as previously disclosed herein. Theretrieval device580 is positioned at a distal end of the delivery catheter so that themain body portion583 is positioned at the site of the obstruction to be retrieved. When sheathed within the delivery catheter themain body portion583 and thedistal portion584 have the same, or substantially the same, diameter. Thereafter, the delivery catheter is withdrawn proximally to cause the constrained retrieval device to expand at the treatment site so that themain body portion583 is at least partially forced into the obstruction and so that at least a portion of thedistal portion584 more gently rests against the duct wall distal to the obstruction. Upon the obstruction being captured within themain body portion583 ofdevice580, the device may be removed from the patient in a manner consistent with one or more of the methods previously disclosed herein. During such removal, as the retrieval device is pulled proximally thedistal portion584 may sweep along the duct wall to entrap portions of the obstruction that may have become dislodged. By virtue of its enhanced diametric dimension, thedistal portion584 maintains contact with the duct wall during all or a portion of the removal procedure.
• Although not shown inFIG. 53, in some implementations the cell structures in thedistal segment584 have wire windings selectively woven through their struts in order to endow the distal segment with a desired radiopacity and/or stiffness as discussed above in relation toFIG. 50.
• Theretrieval device590 illustrated inFIG. 54 is similar todevice580 with a difference being the manner in which thecell structures587 are interconnected.Cell structures587 have aproximal side591, adistal side592, atop side593 and abottom side594. As shown inFIG. 54,cell structures587 are coupled with the adjoiningcell structures586 along at least a portion of theproximal side591. However, the top andbottom sides593 and594 ofcell structures587 are unattached. As mentioned above, it is desirable that the length to width ratio ofcell structures587 remain greater than one when theretrieval device590 is moved through a delivery catheter or duct of a patient. By de-coupling the top and bottom sides of the cell structures, forces that would normally be applied to the cell structures during expansion to cause them to appreciably expand in width are largely removed. This assists in ensuring that the length to width ratio ofcell structures587 remains greater than one when thedevice590 assumes an expanded state. As shown inFIG. 55, as a result of the de-coupling of the distal-most circumferential row of cell structures, the selection of smaller sized cell structures is accommodated. For example, as shown inFIG. 55 the distal-most circumferential row ofcell structures596 may comprise cell structures that are the same or similar to proximally situatedcell structures586. It is appreciated, however, that the size and shape of the distal-most circumferential row of cell structures need not mimic those of the proximally situated cell structures.
• Turning now toFIG. 56A, aretrieval device630 is shown having a similar construction as thedevice800 depicted inFIG. 45A, albeit with fewer cell structures and for use in smaller diameter vessels/ducts.FIG. 56A is a two dimensional view of aretrieval device630 according to another implementation. Theretrieval device630 comprises an expandable member that has a proximaltapered end portion631, a cylindricalmain body portion632 and a distaltapered end portion633. The outer-most cell structures in the proximal tapered end portion have outer wall segments that form on one side anon-undulating rail segment636 and on the other side an undulatingrail segment637. Each of therail segments636 and637 extend from a proximal-most end of the expandable member to a position at or near the proximal end of the cylindricalmain body portion632. Aproximal antenna634 extends proximally from aproximal-most cell structure638 while adistal antenna635 extends distally from the distal end of distaltapered section633. The cell structures640 in the cylindricalmain body portion632 comprise facing proximal anddistal flexure elements641 and642, respectively, which generally comprise convex and/or concave like structures, such as for example V-like and U-like structures. The proximal anddistal flexure elements641 and642 are interconnected by a pair of diagonally extending and circumferentially spaced-apart struts643 and644.
• FIG. 56B shows the as-cut width dimensions in inches of the various struts in the proximaltapered end portion631 according to one implementation, each of the dimensions having a tolerance of ±0.0004 inches. According to one implementation the struts in the proximaltapered end portion631 have an as-cut thickness dimension of about 0.0045±0.0004 inches.
• As previously discussed, it is desirable that the cylindricalmain body portion632 possess sufficient radial strength to cause at least a partial integration of its struts into an obstruction targeted for full or partial removal. However, the radial strength of the cylindricalmain body portion632 must be sufficiently low to avoid undue damage to the vessel or duct under treatment. In order to achieve a desired radial strength the cross-sectional area and/or width and/or thickness of the struts that form the cylindricalmain body portion632 must be properly dimensioned.
• Another feature of consideration is that of flexibility. The cylindricalmain body portion632 should possess sufficient flexibility to permit theretrieval device630 to be advanced and retracted though the tortuous anatomy of a patient. However, the cylindricalmain body portion632 should also possess sufficient stiffness to permit it to be pushed through a delivery catheter and a duct of a patient without it collapsing on itself. It has been discovered that stiffness also plays a factor in the ability of the retrieval device to be withdrawn into a delivery catheter at a point in time after it has been deployed. As discussed above, upon a misplacement of the retrieval device within a duct of a patient, and sometimes upon removal of the retrieval device from the patient, the retrieval device is fully or partially withdrawn back into the delivery catheter. It has been discovered that in the absence of a requisite amount of stiffness within the cylindrical main body portion it is difficult to withdraw the retrieval device back into the delivery catheter after it has been deployed. Tests have shown that in some situations when all the struts within the cylindrical main body portion have a uniform cross-section, insufficient stiffness results when the struts are sized to achieve a proper amount of radial force.
• It has been discovered that the cross-section offlexure elements641 and642 most significantly impact radial force in the cylindricalmain body portion632 while the cross-section of diagonally disposedstruts643 and644 contributing little if any to the radial force produced within the cylindricalmain body portion632. According to some implementations, in order to achieve the right combination of radial strength and stiffness within the cylindricalmain body portion632, the cross-section offlexure elements641 and642 is different than the cross-section ofstruts643 and644. Because in many instances the retrieval device is cut from a tube of uniform thickness, the width dimensions of theflexure elements641,642 and diagonally disposedstruts643,644 are varied to achieve the desired radial force and stiffness characteristics. However, it is to be appreciated that dimensions other than width may be varied to achieve the same or similar results.
• According to some implementations all or substantially all of the struts in the cylindricalmain body portion632 are of the same thickness with theflexure elements641 and642 having a first average width dimension and the diagonally disposedstruts643 and644 having a second average width dimension that is greater than the first average width dimension. The second average width dimension is sufficiently large to compensate for the lack of stiffness that would otherwise exists if the second average width dimension was the same as the first average width dimension. In some implementations the as-cut second average width dimension is in the range of about 1.1 to about 2.0 times greater than the as-cut first average width dimension. In other implementations the as-cut second average width dimension is in the range of about 1.2 to about 1.5 times greater than the as-cut first average width dimension. According to one experiment the as-cut first average width dimension was about 0.0032 inches and the as-cut second average width dimension was about 0.0040 inches. The results showed that the average deflection stiffness of the cylindricalmain body portion632 increased by about a 40% to 50% as a result of increasing the width dimension of the diagonally disposedstruts643 and644 from 0.0032 inches to 0.0040 inches. This occurs without an appreciable increase in radial force.
• FIG. 57 is illustrates aretrieval device650 similar toretrieval device630 with a difference being in the construction of the diagonally disposedstruts643 and644. As shown in the figures, struts643 and644 inretrieval device630 are curvilinear while struts643 and644 inretrieval device650 are straight.
• According to some implementations the width dimensions of the diagonally disposedstruts643 and644 are uniform along their length. With respect to the example dimensions above, it would mean that the entire length ofstruts643 and644 would have an average width dimension of 0.0040 inches. In other implementations struts643 and644 comprise middle segments that are disposed between opposite proximal and distal end segments, with the proximal end segments being coupled to the proximal flexure element and the distal end segments being coupled to the distal flexure element. Using the same example dimensions above, theflexure elements641 and642 along with the proximal and distal segments ofstruts643 and644 may have an average width dimension of 0.0032 inches while the middle segment ofstruts643 and644 may have an average width dimension of 0.0040 inches. In other implementations struts643 and644 comprise middle segments that are disposed between opposite proximal and distal tapered end segments, with the proximal tapered end segments being coupled to theproximal flexure element641 and the distal tapered end segments being coupled to thedistal flexure element642. Using the same example dimensions above, theflexure elements641 and642 may have an average width dimension of 0.0032 inches with the middle segment ofstruts643 and644 having an average width dimension of 0.0040 inches, the average width dimension of the proximal and distal tapered end segments transitioning from 0.0032 inches to 0.0040 inches.
• As disclosed above in the description of the device depicted inFIG. 50, a process of weaving/winding a wire or ribbon about the struts of the retrieval device may be used for the purpose of enhancing the radiopacity of the device and also for affecting the stiffness of the device. In the implementations disclosed above, the discussion was limited to incorporating such a feature into the distal segment of retrieval devices. What follows is a description that involves the use of such wire windings in other portions of the device.
• FIG. 58A illustrates aretrieval device630 that has a similar construction to theretrieval device650 shown inFIG. 56. Theretrieval device660 comprises wires that are wound about selective struts for the purpose of enhancing the radiopacity of thedevice660 and/or to affect the stiffness of one or more portions of the device. In the exemplary implementation ofFIG. 58A three radiopaque wires (or ribbons)661,662 and663 are woven along the length of the retrieval device to enhance the radiopacity of the device along essentially its entire length and to enhance the stiffness of at least the cylindricalmain body portion666. In the implementation ofFIG. 58A the wires661-663 are woven about the diagonally downward oriented struts (as viewed from left to right) in the cylindricalmain body portion666 so that only theshort legs670aof theflexure elements670 possess wire windings. As shown in detail inFIG. 58B, thelong legs670bof theflexure elements670 are free or substantially free of wire windings. A virtue of this winding configuration is that it enables the wires to be applied to the retrieval device, and particularly the cylindricalmain body portion666, in a manner that disproportionally affects stiffness and radial force. For example, the average deflection stiffness of the cylindricalmain body portion666 may be moderately to significantly increased without there being a corresponding increase in the radial force exerted by the cylindrical main body portion when it is in an unexpanded state. Prototypes have shown that the average deflection stiffness of the cylindricalmain body portion666 may be increased by up to 50% with there being relatively little to no increase in the radial force.
• According to one exemplary implementation, the struts in the cylindricalmain body portion666 have an as-cut thickness dimension of about 0.0045 inches with each ofstruts670a,670band671 having width dimensions of about 0.0032, 0.0032 and 0.0040 inches, respectively. In one implementation the wires comprise platinum with a width and/or diameter of between about 0.0020 inches and 0.0025 inches with there being an average of about one to ten windings per strut, and most generally one to five windings per strut. It is to be appreciated that a single wire or any multiple thereof may be used in lieu of the three wire configurations depicted inFIG. 58A. Moreover, it is important to note that, in the case of enhancing radiopacity that the wire or wires may comprise any radiopaque material or combination of materials as discussed above in conjunction withFIG. 50. In the event that wire windings are applied only for the purpose of affecting stiffness, the wire or wires may comprise any material suitable for such purpose, such as for example metallic, polymeric and composite materials. In some implementations the cross-sectional area of the one or more wires varies to provide a variation in radiopacity and/or stiffness along the length of the device.
• According to some implementations, the cylindricalmain body portion666 has a first average deflection stiffness in the absence of the one or more wires or ribbons661-663 and a second average deflection stiffness with presence of the one or more wires or ribbons661-663, the dimensional and material characteristics of the one or more wires or ribbons661-663 and the number of windings per unit length of the diagonally extending and circumferentially spaced-apart struts in the cylindrical main body portion selected to cause the second average deflection stiffness to be greater than the first average deflection stiffness by a factor of between about 1.2 to about 1.8 with there being a disproportionally lower increase in the radial force exerted by the cylindrical main body portion when it is in an unexpanded state.
• According to some implementations the proximal and distal end segments of wires661-663 are coupled to theretriever device660 as depicted inFIG. 59 andFIG. 60, respectively. It is important to note that other attachment/coupling configurations are also possible.FIG. 59A illustrate the proximal attachment of wires661-663 at the location where the distal end of elongate wire40 (see for exampleFIG. 1A) is attached to theproximal antenna675. In one embodiment, the distal end ofwire40 has a flat profile with a width of about 0.005 inches with the width and thickness of theproximal antenna675 being about 0.0063 and about 0.0035 inches, respectively.FIG. 59B illustrates a cross-sectional view of the resulting joint where in one implementation the proximal ends of wires661-663 reside on a bottom side ofproximal antenna675 and the distal end ofelongate wire40 resides on a top side ofproximal antenna675.
• In one implementation, the distal end ofelongate wire40, the proximal ends of wires661-663 and theproximal antenna675 are coupled together within acoil structure680. In one implementation thecoil structure680 has a closely wrappeddistal segment680a, and a loosely wrappedproximal segment680bthat includes one ormore gaps680c. In one implementation, the length ofproximal antenna675 and thecoil680 are substantially equal. Upon thecoil680 being placed over the overlapping components a bonding agent is introduced into the internal cavity of thecoil680 to bond theelongate wire40,proximal antenna675 and wires661-663 together with at least a portion of the coil. In one implementation, the end segments of wires661-663 reside entirely withindistal coil segment680a. The bonding agent may be an adhesive, solder, or any other suitable bonding agent. When the bonding agent is a solder, a preceding step in the process may involve coating the various components with tin or another suitable wetting agent. In one implementation the solder is gold and is used to enhance the radiopacity of the joint so that the joint may serve as a proximal radiopaque marker. This implementation is particularly applicable in situations where wires661-663 are non-radiopaque. In addition to the use of gold, all or portions of the coil may be made of a radiopaque material to further enhance the radiopacity of the joint. In other implementations, in lieu of the use of asingle coil680, two or more coils in abutting relationship are used with, for example, a distal closely wound coil and a proximal loosely wound coil with gaps situated proximal to the closely wound coil.
• FIGS. 60A and 60B illustrate several methods by which the distal end segments of wires661-663 may be attached to thedistal antenna676. In the implementation ofFIG. 60A the distal ends of wires661-663 are bonded directly to the distal antenna by use of a bonding agent such as solder or glue.FIG. 60B shows another implementation where the distal ends of wires661-663 are interposed between thedistal antenna676 and acoil685 that surrounds it. In such an implementation a bonding agent may be introduced into the interior of thecoil685 to effectuate a bonding together thecoil685,distal antenna676 and wires661-663.
• While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. For example, dimensions other than those listed above are contemplated. For example, retrieval devices having expanded diameters of any where between 1.0 and 100.0 millimeters and lengths of up to 5.0 to 10.0 centimeters are contemplated. Moreover, it is appreciated that many of the features disclosed herein are interchangeable among the various implementations. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure. Further, it is to be appreciated that the delivery of a vascular treatment device of the implementations disclosed herein is achievable with the use of a catheter, a sheath or any other device that is capable of carrying the device with the expandable member in a compressed state to the treatment site and which permits the subsequent deployment of the expandable member at a vascular treatment site. The vascular treatment site may be (1) at the neck of an aneurysm for diverting flow and/or facilitating the placement of coils or other like structures within the sack of an aneurysm, (2) at the site of an embolic obstruction with a purpose of removing the embolic obstruction, (3) at the site of a stenosis with a purpose of dilating the stenosis to increase blood flow through the vascular, etc.

Claims (16)

1-20. (canceled)

21. An embolic obstruction retrieval device comprising:

an elongate self-expandable member having a radially expanded configuration and a radially constrained configuration, the expandable member being biased in the expanded configuration and comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements of the plurality being interconnected in a manner to form a plurality of diagonally disposed cells defining a cell pattern, the expandable member having a proximal portion, an elongate central body portion, and a distal portion,

wherein the cell structures in the central body portion are circumferentially disposed about a longitudinal axis of the expandable member, and

wherein a longitudinal slit free of undulating elements extends lengthwise along the central body portion of the expandable member.

22. The embolic obstruction retrieval device ofclaim 21, wherein the slit extends along an entire length of the expandable member.

23. The embolic obstruction retrieval device ofclaim 21, wherein the slit extends diagonally, the slit defining a spiral free of undulating elements around the longitudinal axis of the central body portion.

24. The embolic obstruction retrieval device ofclaim 23, wherein the slit extends diagonally along an entire length of the expandable member.

25. The embolic obstruction retrieval device ofclaim 21, wherein a first undulating element in the proximal portion comprises a first substantially linear rail, and a second undulating element in the proximal portion forms a second substantially linear rail, each of the first and second substantially linear rails forming acute angles with the longitudinal axis of the expandable member, and wherein the slit originates at one of the first and second substantially linear rails.

26. The embolic obstruction retrieval device ofclaim 21, wherein the plurality of adjacent undulating elements are disposed and interconnected in a manner so as to cause each cell of the plurality to be diagonally disposed relative to another cell of the plurality.

27. The embolic obstruction retrieval device ofclaim 21, further comprising a proximally extending elongate wire coupled to a proximal-most end of the proximal portion of the expandable member.

28. The embolic obstruction retrieval device ofclaim 21, further comprising a distally extending wire segment coupled to a distal-most end of the distal portion of the expandable member.

29. The embolic obstruction retrieval device ofclaim 21, wherein the cells in the central body portion of the expandable member are symmetrically aligned with one another along a length of the central body portion.

30. The embolic obstruction retrieval device ofclaim 21, wherein the cells in the central body portion of the expandable member are symmetrically unaligned with one another along a length of the central body portion.

31. The embolic obstruction retrieval device ofclaim 21, wherein at least a portion of the expandable member is coated with a radiopaque material or otherwise comprises radiopaque markers.

32. An embolic obstruction retrieval device comprising:

an elongate self-expandable member having a radially expanded configuration and a radially constrained configuration, the expandable member being biased in the expanded configuration and comprising a plurality of generally longitudinal undulating elements with adjacent undulating elements of the plurality being interconnected in a manner to form a plurality of diagonally disposed cells defining a cell pattern, the expandable member having a proximal portion, an elongate central body portion, and a distal portion, wherein the cell structures in the central body portion are circumferentially disposed about a longitudinal axis of the expandable member,

wherein a longitudinal slit free of undulating elements extends lengthwise and diagonally along the expandable member, the slit defining a spiral free of undulating elements around the longitudinal axis, and

wherein a first undulating element in the proximal portion comprises a first substantially linear rail, and a second undulating element in the proximal portion forms a second substantially linear rail, each of the first and second substantially linear rails forming acute angles with the longitudinal axis of the expandable member, and wherein the slit originates at one of the first and second substantially linear rails.

33. The embolic obstruction retrieval device ofclaim 32, wherein the slit extends along an entire length of the expandable member.

34. The embolic obstruction retrieval device ofclaim 32, wherein the plurality of adjacent undulating elements are disposed and interconnected in a manner so as to cause each cell of the plurality to be diagonally disposed relative to another cell of the plurality.

35. The embolic obstruction retrieval device ofclaim 32, wherein at least a portion of the expandable member is coated with a radiopaque material or otherwise comprises radiopaque markers.

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