Stent graft with braided polymeric sleeve

Claim 2

The process of claim 1 wherein: said forming of structural strands (36) includes arranging the structural strands (36) as first and second sets of helices wound in opposite directions about a common longitudinal axis (38), thereby forming rhombic interstices between adjacent structural strands (36).

Claim 3

The process of claim 2 wherein: said forming of structural strands (36) further includes interbraiding the structural strands (36).

Claim 4

The process of claim 2 wherein: said forming of structural strands (36) further includes braiding the structural strands (36) at a first braid angle with the latticework (34,106,116,130) in its nominal state.

Claim 5

The process of claim 4 wherein: said forming of textile strands (42) includes arranging the textile strands (42) as third and fourth sets of helices wound in opposite directions at a second braid angle when the sleeve (40,108) is in its nominal state.

Claim 6

The process of claim 2 wherein: said structural material is thermally formable, and said forming of structural strands (36) further includes winding the structural strands (36) around a selectively sized first mandrel (58), then heating the strands (36) while so wound to a heat forming temperature sufficient to thermally impart a nominal size and shape for the latticework (34,106,116,130) when in its nominal state; and wherein said textile strands (42) are thermally formable, and said forming of textile strands (42) further includes winding the textile strands (42) around a selectively sized second mandrel (62), then heating the textile strands (42) while so wound to a second heat forming temperature sufficient to thermally impart a nominal size and shape to the sleeve (40,108) when in the nominal state.

Claim 7

The process of claim 6 wherein: said selected one of the latticework (34,106,116,130) and sleeve (40,108) is the latticework (34,106,116,130), and said disposing includes positioning the latticework (34,106,116,130) within and surrounded by the sleeve (40,108).

Claim 8

The process of claim 7 wherein: said first mandrel (58) has a diameter less than that of said second mandrel (62).

Claim 9

The process of claim 2 wherein: said forming of structural strands (36) further includes heat setting the structural strands (36) when they are wound about a first mandrel (58) at a first braid angle to determine a nominal latticework size and shape, said forming of textile strands (42) includes thermally setting the textile strands (42) when they are wound about a second mandrel (62) at a second braid angle to determine a nominal sleeve size and shape.

Claim 10

The process of claim 9 wherein: the second mandrel (62) has a diameter greater than that of the first mandrel (58), and said first and second braid angles are within one degree of one another.

Claim 11

The process of claim 9 wherein: said first and second mandrels (58,62) have substantially the same diameters, and the first braid angle is larger than the second braid angle.

Claim 12

The process of claim 1 further including: prior to said disposing, applying an adhesive to at least one of the latticework (34,106,116,130) and the sleeve (40,108) over at least a portion of its axial length, wherein said forming an attachment includes maintaining the latticework (34,106,116,130) and the sleeve (40,108) in said engagement for a time sufficient for the adhesive to bond the latticework (34,106,116,130) and the sleeve (40,108) to form the composite stent graft (18,90,92,104,112,128).

Claim 13

The process of claim 12 wherein: said applying includes dissolving the adhesive in a liquid solvent, spraying the combined solvent and adhesive onto the at least one of the latticework (34,106,116,130) and sleeve (40,108), and then evaporating the solvent whereby said coating is formed of a residue consisting essentially of the adhesive.

Claim 14

The process of claim 13 wherein: said applying further includes providing the adhesive in the form of a siloxane polymer and dissolving the siloxane polymer in an organic solvent at about 6 percent siloxane polymer by weight.

Claim 15

The process of claim 13 wherein: said adhesive is heat curable, and said forming an attachment includes maintaining the composite stent graft (18,90,92,104,112,124,128) at a temperature of about 125-200 degrees C. for about 20 minutes to one hour.

Claim 16

The process of claim 12 wherein: said adhesive is curable, and applied uncured to said at least one of the latticework (34,106,116,130) and sleeve (40,108); and said forming of the attachment includes curing said adhesive to bond the latticework (34,106,116,130) and sleeve (40,108).

Claim 17

The process of claim 16 wherein: said applying includes electrostatically depositing an adhesive onto the at least one of said latticework (34,106,116,130) and sleeve (40,108).

Claim 18

The process of claim 16 further including: after said curing, plastically deforming the latticework (34,106,116,130) to reduce the radii of the latticework (34,106,116,130) and the sleeve (40,108) to their respective states.

Claim 19

The process of claim 1 wherein: said disposing includes adjusting the selected one of the latticework (34,106,116,130) and sleeve (40,108) to reduce its radius below that in its nominal state, axially aligning the selected one with the other while the other remains in its nominal state, and then radially expanding the selected one toward said engagement with the other.

Claim 20

The process of claim 5 wherein said second braid angle is between 100.91 and 105.45 percent of said first braid angle and the sleeve (40,108) is attached about and in axial alignment with the latticework (34,106,116,130).

Claim 21

The process of claim 5 wherein said second braid angle is between 97.72 and 102.27 percent of said first braid angle and the sleeve (40,108) is attached within and in axial alignment with the latticework (34,106,116,130).

Claim 22

A body insertable stent graft (18,90,92,104,112,124,128), including: a radially expandable stent adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; and a tubular first sleeve (40,108) formed of a plurality of interwoven textile strands (42), adjustable between a nominal state and a radially-reduced and axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; wherein the stent and the sleeve (40,108) are attached together in an axial alignment with one another and in an engagement with one another with a selected one of the stent and sleeve (40,108) surrounding the other.

Claim 23

The stent graft of claim 22 wherein: the stent comprises a plurality of structural strands (36) in a tubular open latticework (34,106,116,130), the structural strands (36) having first and second sets of helices wound in opposite directions about a longitudinal axis (38) of said stent graft (18,90,92,104,112,124,128) and forming a first braid angle with the latticework (34,106,116,130) in its nominal state; and said textile strands (42) are arranged as third and fourth sets of helices wound in opposite directions about said longitudinal axis (38), and form a second braid angle with the sleeve (40,108) in its nominal state; and wherein said second braid angle is within about 5 degrees of the first braid angle.

Claim 24

The stent graft of claim 23 wherein: said second braid angle is within about one degree of the first braid angle.

Claim 25

The stent graft of claim 22 wherein: said structural strands (36) are resilient, whereby the stent tends to assume its nominal state when relaxed.

Claim 26

The stent graft of claim 22 wherein: said sleeve (40,108) is an exterior sleeve that surrounds said stent.

Claim 27

The stent graft of claim 22 wherein: said structural strands (36) are interbraided.

Claim 28

The stent graft of claim 22 wherein: said structural strands (36) are metal monofilaments constructed of at least one of the following materials: stainless steel, an alloy including cobalt and an alloy including titanium.

Claim 29

The stent graft of claim 22 wherein: said monofilaments are polymeric and constructed of at least one of the following materials: PET, polypropylene, PEEK, HDPE, polysulfone, acetyl, PTFE, FEP, and polyurethane.

Claim 30

The stent graft of claim 22 wherein: said textile strands (42) are multifilament yarns formed of at least one of the following materials: PET, polypropylene, high molecular weight polyethylene, polyurethane, HDPE, polyethylene, silicone, PTFE, polyolefins, and PTFE.

Claim 31

The stent graft of claim 22 wherein: at least one of said strands incorporates a radiopaque material.

Claim 32

The stent graft of claim 22 further including: at least one elastomeric strand running axially of the composite stent graft (18,90,92,104,112,124,128) and fused to the stent graft (18,90,92,104,112,124,128) along at least part of its axial length.

Claim 33

The stent graft of claim 22 further including: a coating applied to the composite stent graft (18,90,92,104,112,124,128).

Claim 34

The stent graft of claim 26 further including: a second sleeve formed of the textile strands (42) and providing an interior sleeve surrounded by said stent, wherein the interior sleeve is attached to the stent and adjustable between a nominal state and a radially-reduced axially-elongated state according to a third relationship of radial reduction versus axial elongation substantially equivalent to said first and second relationships, said interior sleeve having substantially the same size and shape as the first sleeve and the stent when in their respective nominal states.

Claim 35

The stent graft of claim 22 wherein: said attachment component comprises an adhesive consisting essentially of a siloxane polymer.

Claim 36

The stent graft of claim 35 wherein: said siloxane polymer occupies at least proximal and distal end portions of a cylindrical region over which the latticework (34,106,116,130) and the sleeve (40,108) are adjacent one another.

Claim 37

The stent graft of claim 36 wherein: said siloxane polymer occupies substantially all of said region.

Claim 38

The stent graft of claim 22 wherein the stent structurally supports the sleeve (40,108).

Claim 39

The stent graft of claim 22 wherein said second braid angle is between 100.91 and 105.45 percent of said first braid angle and the sleeve (40,108) is attached about and in axial alignment with the stent.

Claim 40

The stent graft of claim 22 wherein said second braid angle is between 97.72 and 102.27 percent of said first braid angle and the sleeve (40,108) is attached within and in axial alignment with the stent.

Claim 41

A process for making a stent graft, including: providing a tubular stent comprised of a plurality of structural strands (36) and adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; providing a tubular sleeve (40,108) comprised of a plurality of compliant textile strands (42), having a nominal state in which the sleeve (40,108) is substantially the same size and shape as the stent in its nominal state, and adjustable between said nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; disposing a selected one of the stent and the sleeve (40,108) within and in an axial alignment with the other of the stent and sleeve (40,108), so that said other surrounds the selected one, then bringing the stent and sleeve (40,108) into an engagement; and while maintaining the stent and sleeve (40,108) in said engagement, binding the latticework (34,106,116,130) and the sleeve (40,108) together to form a composite stent graft (18,90,92,104,112,124,128).

Claim 42

The process of claim 41 further including: applying an adhesive to at least one of the stent and the sleeve (40,108) over at least a portion of its axial length; and wherein said binding includes maintaining the sleeve (40,108) and the stent in said engagement for a time sufficient for the adhesive to bond the sleeve (40,108) and stent to form the composite stent graft (18,90,92,104,112,124,128).

Claim 43

The process of claim 42 wherein: said adhesive is a curable adhesive, and is applied uncured to the at least one of said stent and sleeve (40,108); and said binding of the stent and sleeve (40,108) includes curing the adhesive.

Claim 44

The process of claim 41 wherein: said disposing includes adjusting said selected one of the stent and sleeve (40,108) to reduce its radius below that in its nominal state, axially aligning the selected one while radially reduced with the other of said stent and sleeve (40,108) while said other remains in its nominal state, then radially expanding said selected one toward said engagement with the other.

Claim 45

A body insertable stent graft (18,90,92,104,112,124,128), including: a tubular stent adjustable between a nominal state and a radially-reduced and axially-elongated state; and a tubular fabric sleeve (40,108) adjustable between a nominal state and a radially-reduced and axially-elongated state, formed of a plurality of textile strands (42), wherein each of the textile strands (42) consists essentially of a multifilament yarn (142) in which the filaments (144) have surface twist angles of at most about 15 degrees, said sleeve and said stent having substantially the same radii when in their respective nominal states; wherein the stent and the sleeve (40,48) are attached together in axial alignment with one another and with a selected one of the stent and sleeve (40,108) surrounding the other.

Claim 46

The stent graft of claim 45 wherein: said multiple filaments further are arranged to define a yarn (142) cross section with an aspect ratio greater than 1.

Claim 47

The stent graft of claim 46 wherein: said aspect ratio is in the range from about 2 to about 12.

Claim 48

The stent of claim 45 wherein the stent structurally supports the sleeve (40,108).

Claim 49

A body insertable stent graft, including: a stent adjustable between a nominal state and radially-reduced and axially-elongated state; and a tubular fabric sleeve (40,108) formed of a plurality of textile strands (42), each textile strand (42) consisting essentially of a multifilament yarn (142) in which multiple filaments (144) thereof are arranged to define a yam cross-section having an aspect ratio of at least about 2, said fabric sleeve (40,108) adjustable between a nominal state and a radially-reduced and axially-elongated state, said sleeve (40,108) and said stent having substantially the same radii when in their respective nominal states; wherein the stent and the sleeve (40,108) are attached together in an axial alignment and with a selected one of the stent and sleeve surrounding the other, with the stent structurally supporting the sleeve (40,108).

Claim 50

The stent graft of claim 49 wherein: the textile strands (42) are oriented with their minimum cross-sectional dimensions aligned substantially radially of the tubular fabric sleeve (40,108) and the filaments of the textile strands (42) have surface twist angles of at most about 15 degrees.