US6149681A — Radially expanding prostheses and systems for the…

Claim 1

Independent Claim 165 words

An intralumenally implantable prosthesis including: a structural layer including a single elongate primary section extended in a longitudinal direction, the structural layer further including a plurality of secondary sections extended substantially transversally from the primary section and curved about an axis substantially parallel to the primary section, whereby the structural layer is thermally set so to conform, when in a substantially relaxed and fully deployed state, to a cylindrical shape having a predetermined radius, wherein the secondary sections are flexible to allow a radial reduction of the structural layer to a reduced-radius delivery profile responsive to an external force, and wherein the structural layer requires a continued application of the external force to maintain the reduced-radius delivery profile and alternatively tends to return to the substantially relaxed and fully deployed state upon removal of the external force; and a substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and substantially impervious to blood.

Claim 2

Dependent Claim 165 words

An intralumenally implantable prosthesis including: a structural layer including a single elongate primary section extended in a longitudinal direction, the structural layer further including a plurality of secondary sections extended substantially transversally from the primary section and curved about an axis substantially parallel to the primary section, whereby the structural layer is thermally set so to conform, when in a substantially relaxed and fully deployed state, to a cylindrical shape having a predetermined radius, wherein the secondary sections are flexible to allow a radial reduction of the structural layer to a reduced-radius delivery profile responsive to an external force, and wherein the structural layer requires a continued application of the external force to maintain the reduced-radius delivery profile and alternatively tends to return to the substantially relaxed and fully deployed state upon removal of the external force; and a substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and substantially impervious to blood.

Claim 3

Dependent Claim 39 words

The prosthesis of claim 1 wherein: each of the secondary sections converges in profile in a direction from a first end of the secondary segment adjacent the primary segment toward a second and opposite end of the secondary section.

Claim 4

Dependent Claim 44 words

The prosthesis of claim 1 wherein: the structural layer when in the delivery profile is positionable at a treatment site along a tissue wall defining a body lumen, and radially expands into contact with the tissue wall segment upon release of the external force.

Claim 5

Dependent Claim 34 words

The prosthesis of claim 3 further including: a heating component for heating at least a portion of the tissue near the treatment site while the support structure is in contact with the tissue wall.

Claim 6

Dependent Claim 44 words

The prosthesis of claim 4 wherein: the heating means comprises at least one electrical heating element mounted adjacent the structural layer, and a means for providing an electrical current to the heating element to thermally bond the structural layer to the tissue wall segment.

Claim 7

Dependent Claim 36 words

The prosthesis of claim 1 wherein: said secondary sections extend from opposite sides of the primary section, and opposed ones of the secondary sections overlap one another when the structural layer is in the relaxed state.

Claim 8

Dependent Claim 39 words

The prosthesis of claim 1 wherein: the secondary members extend from opposite sides of the primary section, and respective ends of opposed second sections are spaced apart from one another when the structural layer is in the relaxed state.

Claim 9

Dependent Claim 107 words

The prosthesis of claim 1 additionally comprising: an elongate and flexible delivery device having a proximal end and a distal end, intravascularly insertable by its distal end, to position the distal end at an intralumenal site while the proximal end remains outside of the body; said delivery device including a prosthesis confining structure near the distal end of the device, for applying the external force to maintain the structural layer in the reduced-radius delivery profile; and a control component operable from the proximal end of the device, for removing the external force to allow the structural layer to radially expand into contact with tissue at the site.

Claim 10

Dependent Claim 72 words

The system of claim 8 wherein: the delivery device is a catheter, the confining structure includes a catheter wall defining a lumen extending at least along the distal end of the catheter and adapted to maintain the structural layer in the delivery state; and the control component includes a means for moving the structural layer distally relative to the catheter, beyond the distal end to allow the structural layer to radially expand.

Claim 11

Dependent Claim 48 words

The system of claim 9 wherein: the moving means includes a stylet adapted to engage a proximal end of the structural layer and either (i) move the structural layer distally while the catheter remains stationary; or (ii) maintain the structural layer stationary while the catheter is proximately withdrawn.

Claim 12

Dependent Claim 67 words

The prosthesis of claim 1 further including: a second substantially continuous and compliant graft layer supported by the structural layer, disposed adjacent the first graft layer and cooperating with the first graft layer to form at least one pocket containing at least one of: a drug solution for diffusion into the tissue; and a biocompatible foam adapted to solidify after said expansion into contact with the tissue.

Claim 13

Dependent Claim 163 words

The graft of claim 11 additionally comprising: an elongate and flexible delivery device having a proximal end and a distal end, intravascularly insertable by its distal end, to position the distal end at an intralumenal site while the proximal end remains outside of the body; said delivery device including first and second elongate stylets near the distal end of the device for applying the external force to maintain the structural layer in the reduced-radius delivery profile, the stylets being releasably coupled to proximal and distal ends of the structural layer, respectively; the stylets being axially movable relative to one another so to axially elongate the structural layer and radially reduce the structural layer to the delivery profile; the stylets additionally being axially movable to allow the structural layer to radially expand; and a control component operable from the proximal end of the device for removing the external force to allow the structural layer to radially expand into contact with tissue at the site.

Claim 14

Dependent Claim 78 words

An intravascularly implantable graft, including: a tubular graft body consisting essentially of an elastomer and self-supporting to have a predetermined radius when in a substantially relaxed and fully deployed state, said graft body having a continuous tubular wall substantially impervious to blood and other body fluids, said body being collapsible into a reduced-radius profile responsive to the application of an external force, and resiliently returning toward the substantially relaxed, fully deployed state upon removal of the external force.

Claim 15

Dependent Claim 78 words

An intravascularly implantable graft, including: a tubular graft body consisting essentially of an elastomer and self-supporting to have a predetermined radius when in a substantially relaxed and fully deployed state, said graft body having a continuous tubular wall substantially impervious to blood and other body fluids, said body being collapsible into a reduced-radius profile responsive to the application of an external force, and resiliently returning toward the substantially relaxed, fully deployed state upon removal of the external force.

Claim 16

Dependent Claim 32 words

The prosthesis of claim 13 wherein: the graft body includes opposite flared end regions, each having a radius larger than the predetermined radius when the graft body is in the relaxed state.

Claim 17

Dependent Claim 138 words

An intraluminally implantable prosthesis, including: a structural layer forming a framework curved about an axis and having a predetermined radius when in a relaxed state, adapted to undergo a radial compression to a reduced-radius delivery profile responsive to an external force, and tending to return to the relaxed state upon removal of the external force, said structural layer when in the delivery profile being positionable at a treatment site along a tissue wall defining a body lumen and adapted to radially expand into contact with the tissue wall segment upon release of the external force; and a heating element supported by the structural layer, adapted for heating at least a portion of the tissue wall segment contiguous with the structural layer sufficiently to thermally bond the structural layer with respect to said portion of the tissue wall segment.

Claim 18

Dependent Claim 138 words

An intraluminally implantable prosthesis, including: a structural layer forming a framework curved about an axis and having a predetermined radius when in a relaxed state, adapted to undergo a radial compression to a reduced-radius delivery profile responsive to an external force, and tending to return to the relaxed state upon removal of the external force, said structural layer when in the delivery profile being positionable at a treatment site along a tissue wall defining a body lumen and adapted to radially expand into contact with the tissue wall segment upon release of the external force; and a heating element supported by the structural layer, adapted for heating at least a portion of the tissue wall segment contiguous with the structural layer sufficiently to thermally bond the structural layer with respect to said portion of the tissue wall segment.

Claim 19

Dependent Claim 29 words

The prosthesis of claim 15 further including: a means for providing an electrical current to the heating element to effect said heating, wherein the heating element is electrically conductive.

Claim 20

Dependent Claim 28 words

The prosthesis of claim 16 wherein: the heating element comprises a plurality of elongate electrode strips fixed with respect to the structural layer, and disposed radially outward thereof.

Claim 21

Dependent Claim 37 words

The prosthesis of claim 16 further including: an indifferent electrode coupled to the current source, said current source being an RF current source, wherein the indifferent electrode is positionable in spaced apart relation to the heating element.

Claim 22

Dependent Claim 38 words

The prosthesis of claim 16 further including: a substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and substantially impervious to blood and other body fluids.

Claim 23

Dependent Claim 47 words

The prosthesis of claim 15 wherein: the structural layer includes at least one elongate primary section extended in a direction parallel to the axis, and further includes a plurality of secondary sections extended substantially transversally from the at least one primary section and curved about the axis.

Claim 24

Dependent Claim 70 words

An intraluminal implantable graft including: a compliant tubular body defining a lumen and having first and second ends; a support structure attached to the tubular body, defining the shape of the tubular body, and having first and second support portions at the first and second ends, respectively; and an electrode structure attached to the tubular body and having first and second electrode portions at the first and second ends, respectively.

Claim 25

Dependent Claim 70 words

An intraluminal implantable graft including: a compliant tubular body defining a lumen and having first and second ends; a support structure attached to the tubular body, defining the shape of the tubular body, and having first and second support portions at the first and second ends, respectively; and an electrode structure attached to the tubular body and having first and second electrode portions at the first and second ends, respectively.

Claim 26

Dependent Claim 20 words

The graft of claim 21 wherein: said portions of the support structure are electrically conductive and provide said electrode portions.

Claim 27

Dependent Claim 53 words

The graft of claim 21 wherein: the support structure is adapted to assume a delivery profile responsive to application of an external force to facilitate an intraluminal positioning thereof along a tissue wall defining a body lumen, and is radially expandable into contact with the tissue wall upon release of the external force.

Claim 28

Dependent Claim 24 words

The graft of claim 23 wherein: the electrode structure is adapted to heat the tissue wall while the support structure is in contact therewith.

Claim 29

Dependent Claim 49 words

The graft of claim 23 wherein: the electrode structure comprises at least one electrical heating element mounted adjacent the support structure, and a means for transmitting an electrical current to the heating element to facilitate a thermal securement of the tubular body and support structure to the tissue wall.

Claim 30

Dependent Claim 73 words

The graft of claim 21 wherein: the tubular body includes at least two compliant graft layers supported by the support structure; and the at least two compliant graft layers form at least one pocket adapted to contain at least one of: a solution adapted for treatment of tissue at the treatment site; an adhesive solution for enhancing bonding of the tubular body to tissue at the treatment site; and a biocompatible, curable foam.

Claim 31

Dependent Claim 16 words

The graft of claim 26 wherein: the at least two compliant graft layers have different porosities.

Claim 32

Dependent Claim 49 words

The graft of claim 27 wherein: the at least two compliant graft layers comprise a substantially non-porous inner graft layer, and a substantially porous outer graft layer, thereby facilitating a selective diffusion of a solution contained in the at least one pocket at least primarily in the outward direction.

Claim 33

Dependent Claim 59 words

The graft of claim 26 wherein: said at least one pocket is adapted to contain said solution for diffusion to the tissue at the treatment site, and said electrode structure includes an electrical element and means for transmitting an electrical current to the electrical element with an amplitude sufficient to cause electroporation of the tissue adjacent the electrical element.

Claim 34

Dependent Claim 37 words

The system of claim 26 wherein: said power source is adapted to provide to the at least one electrode an electrical current of sufficient amplitude to cause electroporation of the tissue adjacent the at least one electrode.

Claim 35

Independent Claim 122 words

A system for securing an implantable graft to a vessel, including: a compliant graft; at least one support structure attached to and supporting the graft; at least one electrode attached to the graft adjacent the at least one support structure; at least one electrical conductor; a power source for providing an electrical current to the at least one electrode via the conductor sufficient to heat tissue adjacent the at least one electrode to thermally secure the graft and support structure with respect to said tissue; and an electrical coupling of the conductor with the at least one electrode, adapted to facilitate a separation of the conductor from the at least one electrode after the graft and support structure have been so secured.

Claim 36

Independent Claim 122 words

A system for securing an implantable graft to a vessel, including: a compliant graft; at least one support structure attached to and supporting the graft; at least one electrode attached to the graft adjacent the at least one support structure; at least one electrical conductor; a power source for providing an electrical current to the at least one electrode via the conductor sufficient to heat tissue adjacent the at least one electrode to thermally secure the graft and support structure with respect to said tissue; and an electrical coupling of the conductor with the at least one electrode, adapted to facilitate a separation of the conductor from the at least one electrode after the graft and support structure have been so secured.

Claim 37

Dependent Claim 13 words

The system of claim 31 wherein: the support structure comprises the electrode structure.

Claim 38

Dependent Claim 48 words

The system of claim 31 wherein: the support structure is adapted to assume a delivery profile to facilitate deployment of the support structure and graft to a treatment site along a tissue wall defining a body lumen, and further is radially expandable into contact with the tissue wall.

Claim 39

Dependent Claim 35 words

The system of claim 31 further including: an indifferent electrode electrically coupled to the power source and positionable in spaced-apart relation to the at least one electrode, wherein the power source comprises an RF generator.

Claim 40

Dependent Claim 42 words

The system of claim 31 wherein: said electrical coupling of the conductor and the at least one electrode comprises a constriction adapted to undergo a breakdown when subjected to current of a predetermined amplitude, thereby to sever the conductor from the electrode.

Claim 41

Dependent Claim 69 words

The system of claim 31 wherein: the graft includes at least two compliant graft layers supported by the support structure and cooperating to form at least one pocket adapted to contain at least one of: a solution adapted for diffusion from the pocket to adjacent tissue to treat the adjacent tissue; an adhesive solution to promote a bonding of the graft to the tissue; and a biocompatible, curable foam.

Claim 42

Dependent Claim 158 words

An intralumenally implantable prosthesis including: a structural layer including a single elongate primary section extended in a longitudinal direction, the structural layer further including a plurality of secondary sections extended substantially transversely from the primary section, the structural layer being thermally set so that when in a relaxed state the plurality of secondary sections are curved about an axis substantially parallel to the primary section to impart a substantially cylindrical shape to the structural layer; wherein the structural layer self-expands from a reduced-radius delivery profile to an enlarged-radius deployment profile upon removal of an external force, wherein each of the secondary sections converges in profile in a direction from a first end of the secondary segment adjacent the primary segment toward a second and opposite end of the secondary section; and a substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and substantially impervious to blood.

Claim 43

Dependent Claim 158 words

An intralumenally implantable prosthesis including: a structural layer including a single elongate primary section extended in a longitudinal direction, the structural layer further including a plurality of secondary sections extended substantially transversely from the primary section, the structural layer being thermally set so that when in a relaxed state the plurality of secondary sections are curved about an axis substantially parallel to the primary section to impart a substantially cylindrical shape to the structural layer; wherein the structural layer self-expands from a reduced-radius delivery profile to an enlarged-radius deployment profile upon removal of an external force, wherein each of the secondary sections converges in profile in a direction from a first end of the secondary segment adjacent the primary segment toward a second and opposite end of the secondary section; and a substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and substantially impervious to blood.

Claim 44

Dependent Claim 16 words

The prosthesis of claim 37 wherein: said structural layer is formed of a memory elastic material.

Claim 45

Dependent Claim 121 words

An intraluminal implantable graft including: a self-supporting structural layer; a first substantially continuous and compliant graft layer supported by the structural layer and tending to conform to the shape of the structural layer; and a second substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and cooperating with the first graft layer to form a pocket containing at least one constituent selected from the group of constituents consisting of: a solution adapted for treatment of tissue at a treatment site within a body lumen; an adhesive solution for enhancing bonding of at least one of the graft layers to tissue at the treatment site; and a biocompatible, curable foam.

Claim 46

Dependent Claim 121 words

An intraluminal implantable graft including: a self-supporting structural layer; a first substantially continuous and compliant graft layer supported by the structural layer and tending to conform to the shape of the structural layer; and a second substantially continuous and compliant graft layer, supported by the structural layer, tending to conform to the shape of the structural layer, and cooperating with the first graft layer to form a pocket containing at least one constituent selected from the group of constituents consisting of: a solution adapted for treatment of tissue at a treatment site within a body lumen; an adhesive solution for enhancing bonding of at least one of the graft layers to tissue at the treatment site; and a biocompatible, curable foam.

Claim 47

Dependent Claim 20 words

The graft of claim 39 wherein: one of said first and second graft layers is more porous than the other.

Claim 48

Dependent Claim 35 words

The graft of claim 39 further including: at least one electrode attached to at least one of the first and second graft layers, and an electrical conductor electrically coupled to the at least one electrode.

Claim 49

Dependent Claim 35 words

The graft of claim 39 wherein: the support layer is elastically deformable into a reduced-radius delivery profile responsive to application of an external force, and tends to radially enlarge upon removal of the external force.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2003-11-21	2004-05-22	2004-11-21	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2007-11-21	2008-05-22	2008-11-21	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2011-11-21	2012-05-22	2012-11-21	$7700.00	Window Closed / Lapsed

Radially expanding prostheses and systems for their deployment

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