Multicapsule intraluminal grafting system and method

A system for repairing a lumen, said system comprising:

• a graft having a first end and an second end;
• a first capsule for removably retaining the first end of said graft;
• and
• catheter means for positioning said graft and said first capsule into the lumen, said catheter means having an inflatable member and a second capsule for removably retaining the second end of said graft.

A system for implanting a prothesis in a corporeal lumen having a wall, said system comprising:

• a graft having superior and inferior ends, said graft having attachment means located at the superior and inferior ends;
• a capsule catheter having an elongate tubular member having proximal and distal ends, said capsule catheter having a proximal capsule positioned at the distal end of the elongate tubular member;
• and
• a balloon catheter disposed within said capsule catheter, said balloon catheter including a second elongate tubular member having proximal and distal ends, an inflatable member positioned proximal the distal end of the second elongate tubular member, and a distal capsule positioned proximate the distal end of the second elongate tubular member;
• wherein the superior end of said graft is removably retained in the distal capsule, and the inferior end of said graft is removably retained in the proximal capsule.

A system for implanting a prothesis proximate an aortic bifurcation having an aneurism, said system comprising:

• a graft having superior and inferior ends, said graft having attachment means located at the superior and inferior ends;
• a capsule catheter having an elongate tubular member having proximal and distal ends, said capsule catheter having a proximal capsule positioned at the distal end of the elongate tubular member;
• a balloon catheter disposed within said capsule catheter, said balloon catheter including a second elongate tubular member having proximal and distal ends, an inflatable member positioned proximal the distal end of the second elongate tubular member, and a distal capsule positioned proximate the distal end of the second elongate tubular member;
• and
• a capsule jacket slidably positioned coaxially with said capsule catheter and said balloon catheter, wherein the capsule jacket is of sufficient length to cover both the proximal capsule and the distal capsule such that the superior end of said graft is removably retained in the distal capsule, and the inferior end of said graft is removably retained in the proximal capsule.

A system for placing a graft in a lumen formed by a wall in a body, said system comprising:

• a tubular graft having a superior extremity and an inferior extremity, said graft being deformable between a collapsed condition and an expanded condition;
• first anchoring means secured to the superior extremity of said graft for attaching the superior extremity of said graft to the lumen wall;
• second anchoring means secured to the inferior extremity of said graft for attaching the inferior extremity of said graft to the lumen wall;
• a distal capsule assembly for covering said first anchoring means;
• a proximal capsule assembly for covering said second anchoring means, wherein at least a portion of said graft between said first and second anchoring means remains uncovered;
• and
• placement means for positioning said graft, said distal capsule assembly and said proximal capsule assembly at a desired location in the lumen,
• said placement means including means for moving said distal capsule assembly relative to said proximal capsule assembly to uncover said first anchoring means and means for moving said proximal capsule assembly relative to said graft to uncover said second anchoring means.

A system for placing a graft in a lumen formed by a wall proximate an aortic bifurcation having an aneurism, said system comprising:

• a tubular graft having a superior extremity and an inferior extremity, said graft being deformable between a collapsed condition and an expanded condition;
• first anchoring means secured to the superior extremity of said graft for attaching the superior extremity of said graft to the lumen wall;
• second anchoring means secured to the inferior extremity of said graft for attaching the inferior extremity of said graft to the lumen wall;
• a distal capsule assembly for covering said first anchoring means;
• a proximal capsule assembly for covering said second anchoring means, wherein at least a portion of said graft between said first and second anchoring means remains uncovered;
• a removable sleeve of a flexible material, said removable sleeve configured to extend over said proximal capsule assembly, said graft and at least a portion of said distal capsule assembly, wherein a smooth transition is provided between said distal capsule assembly and said proximal capsule assembly;
• a first catheter including a balloon secured to a flexible elongate shaft having an inflation lumen in fluid communication with the balloon, said first catheter being capable of moving the balloon within said graft and into engagement with said first anchoring means and with said second anchoring means;
• a control wire having a proximal end and a distal end secured to the distal capsule assembly, the shaft of the first catheter being provided with a control wire lumen for slidably retaining the control wire, whereby the distal capsule assembly moves relative to the shaft by movement of the proximal end of the control wire;
• and
• a second catheter including a flexible elongate shaft having a proximal end positioned distal the proximal end of the shaft of said first catheter and having a distal end secured to the proximal capsule assembly, such that movement of said second catheter may move said proximal capsule assembly without moving said distal capsule assembly,
• wherein the shaft of said first catheter is coaxially disposed within the shaft of said second catheter, said removable sleeve being coaxially disposed over both the shaft of said first catheter and the shaft of said second catheter.

A method for securing a graft in a corporeal lumen, said graft having a superior end and an inferior end, said graft further having superior attachment means disposed proximate the superior end and having inferior attachment means disposed proximate the inferior end, said method comprising the steps of:

• providing placement means having distal capsule means for containing said superior attachment means and the superior end of said graft, said placement means further having proximal capsule means for containing said inferior attachment means and the inferior end of said graft;
• positioning said placement means and said graft at a desired location within the corporeal lumen;
• withdrawing said distal capsule means from the superior end of said graft and said superior attachment means;
• withdrawing said proximal capsule means from the inferior end of said graft and said inferior attachment means;
• and
• removing said placement means from the corporeal lumen, wherein said graft remains secured within the corporeal lumen.

A method for implanting a graft in a corporeal lumen having a wall, said graft having superior and inferior ends, said graft further having superior attachment means disposed proximate the superior end and having inferior attachment means disposed proximate the inferior end, said method comprising the steps of:

• providing placement means having distal capsule means for removably retaining said superior attachment means and the superior end of said graft, said placement means having proximal capsule means for removably retaining said inferior attachment means and the inferior end of said graft, and said placement means having an inflatable member;
• positioning said placement means and said graft at a desired location within the corporeal lumen;
• removing said distal capsule means from the superior end of said graft and said superior attachment means;
• activating said inflatable member to engage said superior attachment means with the wall of the corporeal lumen;
• removing said proximal capsule means from the inferior end of said graft and said inferior attachment means;
• and
• activating said inflatable member to engage said inferior attachment means with the wall of the corporeal lumen.

A method for emplacement of a graft into a corporeal lumen having a wall, said graft having a superior end secured to a superior attachment system and an inferior end secured to an inferior attachment system, said method comprising the steps of:

• providing placement means comprising a balloon catheter having distal capsule means and an inflatable member, said placement means further comprising a capsule catheter having proximal capsule means;
• placing said superior attachment system in said distal capsule means, wherein the superior end of said graft is removably retained within said distal capsule means;
• placing said inferior attachment system in said proximal capsule means, wherein the inferior end of said graft is removably retained within said proximal capsule means;
• inserting said placement means into the lumen;
• positioning said graft at a desired position within the lumen;
• removing said distal capsule means from the superior end of said graft and said superior attachment system;
• inflating said inflatable member to engage said superior attachment system, thereby securing the superior end of said graft to the wall of the lumen;
• removing said proximal capsule means from the inferior end of said graft and said inferior attachment system;
• inflating said inflatable member to engage said inferior attachment system, thereby securing the inferior end of said graft to the wall of the lumen;
• and
• removing said placement means from the lumen.

A method for emplacement of a graft in a corporeal lumen having a wall, the graft having anchoring means and being disposed within placement means comprising a balloon catheter having a distal capsule, an inflatable member and shaft means coupled to the distal capsule and the inflatable member, the placement means further comprising a capsule catheter having a proximal capsule and shaft means coupled to the proximal capsule, said method comprising the steps of:

• manipulating the placement means to advance the graft, the balloon catheter and the capsule catheter into the corporeal lumen, wherein the graft and the anchoring means are removably retained in the distal and proximal capsules to prevent the anchoring means from contacting the corporeal lumen wall while the graft is being advanced through the corporeal lumen;
• positioning the graft at a desired location in the corporeal lumen;
• removing the distal and proximal capsules from the graft and anchoring means;
• inflating the inflatable member to engage the graft and anchoring means so that the anchoring means and the graft are secured to the lumen wall;
• deflating the inflatable member;
• and
• withdrawing the placement means from the graft and from the corporeal lumen, wherein the graft is retained within the corporeal lumen.

A method for implanting a graft in a corporeal lumen wall afflicted by an aneurysm having a superior end, the graft having superior anchoring means and inferior anchoring means, said method comprising the steps of:

• covering the superior anchoring means of the graft with distal capsule means;
• covering the inferior anchoring means of the graft with proximal capsule means;
• covering the graft, the distal capsule means and the proximal capsule means with a sheath;
• introducing an inflatable member, the graft, the distal capsule means, the proximal capsule means and the sheath into the lumen and then along the lumen until the graft reaches the aneurysm;
• uncovering the superior anchoring means when the graft is positioned in the lumen such that the superior anchoring means is superior to the superior end of the aneurysm;
• inflating the inflatable member to engage the graft and the superior anchoring means with the lumen;
• uncovering the inferior anchoring means;
• deflating the inflatable member;
• inflating the inflatable member to engage the graft and the inferior anchoring means with the lumen;
• deflating the inflatable member;
• and
• removing the inflatable member, the distal capsule means, the proximal capsule means and the sheath from the lumen, wherein the graft is retained in the lumen.

A method for implanting a graft in a corporeal lumen having a wall afflicted by an aneurysm having a superior end, the graft including a superior attachment system having wall engaging members, the graft further including an inferior attachment system having wall engaging members, said method comprising the steps of:

• covering the inferior attachment system of the graft with a proximal capsule, the proximal capsule being coupled to a first shaft;
• covering the superior attachment system of the graft with a distal capsule, the distal capsule being coupled to a second shaft in fluid communication with a balloon, wherein the second shaft is coaxially and slidably disposed within the first shaft;
• covering the graft, the distal capsule and the proximal capsule with a sheath slidably disposed over the first and second shafts;
• introducing the graft, the distal capsule, the proximal capsule and the sheath into the lumen;
• positioning the graft such that the superior attachment system is located superior to the superior end of the aneurysm;
• removing the sheath from the distal capsule;
• removing the distal capsule from the superior attachment system;
• positioning the balloon adjacent the superior attachment system;
• inflating the balloon to urge the wall engaging members of the superior attachment system into the wall of the lumen;
• removing the sheath from the proximal capsule;
• removing the proximal capsule from the inferior attachment system;
• deflating the balloon;
• positioning the balloon adjacent the inferior attachment system;
• inflating the balloon to urge the wall engaging members of the inferior attachment system into the wall of the lumen;
• deflating the balloon;
• and
• removing the balloon, the distal capsule, the proximal capsule, and the sheath from the lumen, wherein the graft is retained in the lumen.

A method for engrafting a prosthesis into a corporeal lumen, said prosthesis having superior and inferior ends, said prosthesis further having a superior attachment means at the superior end and an inferior attachment means at the inferior end, said method comprising the steps of:

• (a) providing delivery means for positioning said graft in the lumen, wherein said delivery means comprises a distal capsule means for removably retaining said superior attachment means and a proximal capsule means for removably retaining said inferior attachment means;
• (b) providing capsule jacket means for removably retaining said graft, said distal capsule means and said proximal capsule means;
• (c) placing the superior end of said prothesis and said superior attachment means into said distal capsule means;
• (d) placing the inferior end of said prothesis and said inferior attachment means into said proximal capsule means;
• (e) placing said prothesis and said delivery means into said capsule jacket means;
• (f) creating an opening in the lumen for passing said capsule jacket means, said delivery means and said prosthesis therethrough;
• (g) inserting said capsule jacket means, said delivery means and said prosthesis into the opening in the lumen;
• (h) urging said prosthesis to a desired location within the lumen;
• (i) positioning said superior attachment means of said prosthesis at a desired location within the lumen;
• (j) activating said superior attachment means to secure the superior end of said prosthesis within the lumen;
• (k) activating said inferior attachment means to secure the inferior end of said prosthesis within the lumen;
• (l) removing said delivery means from the lumen;
• and
• (m) closing the opening in the lumen.

A balloon catheter comprising:

• an elongate tubular member having a proximal end and a distal end;
• a first lumen extending from the proximal end to the distal end of said elongate tubular member, said first lumen configured to receive a guidewire;
• a second lumen extending from the proximal end to proximate the distal end of said elongate tubular member;
• an inflatable member in fluid communication with said second lumen and positioned proximate the distal end of said elongate tubular member;
• and
• capsule means for removably retaining a prothesis, said capsule means positioned proximate the distal end of said elongate tubular member.