Multicapsule intraluminal grafting system and method

• US 5,782,909 A
• Filed: 08/14/1997
• Issued: 07/21/1998
• Est. Priority Date: 08/05/1993
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Piplani, Alec A., Quiachon, Dinah B., Baughman, Larry G.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/911,379
• Time in Patent Office: 341 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• US Class Current: 606/194
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30451 soldered or brazed or welded
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An intraluminal grafting system having a balloon catheter assembly, a capsule catheter assembly and capsule jacket assembly is used for deploying a graft having attachment means in the vessel of an animal body. The system contains a proximal capsule means and a distal capsule means, wherein the graft is disposed within the two capsule means and a removable sheath covers the graft and capsule means. The graft is comprised of a tubular member having superior and inferior ends, having attachment means with wall engaging members secured thereto. The balloon catheter is disposed within the capsule catheter to provide relative movement between the balloon catheter and the capsule catheter, whereby the graft can be removed from the capsule means. The balloon is inflated to firmly implant the graft and attachment means within the vessel. The graft and attachment means remain in the vessel after the intraluminal grafting system is withdrawn.

Claims

1. 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.

2. The method of claim 1, wherein the proximal capsule means is withdrawn before the distal capsule means is withdrawn.

3. The method of claim 1, wherein the positioning step includes placing said graft proximate an aneurism proximate an aortic bifurcation.

4. 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.

5. The method of claim 4, wherein said proximal capsule means is removed from said inferior attachment means before said distal capsule means is removed from said superior attachment means.

6. The method of claim 4, wherein said positioning step includes making a cutdown in a femoral artery, inserting said placement means in the femoral artery and placing said graft proximate an aortic aneurism, such that said removing steps causes the superior end of said graft to be positioned superior the aneurism and the inferior end of the graft to be positioned inferior the aneurism.

7. 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.

8. The method of claim 7, further comprising the steps of:

providing a capsule jacket coaxially disposed over said capsule catheter, wherein said balloon catheter is coaxially disposed within said capsule catheter and said capsule jacket covers said graft, said proximal capsule means, and at least a portion of said distal capsule means;

axially withdrawing said capsule jacket from the superior end of said graft prior to the first removing step; and

axially withdrawing said capsule jacket from the inferior end of said graft prior to the second removing step.

9. The method of claim 7, wherein said inserting step includes making a cutdown in a femoral artery and placing said placement means in the femoral artery, and wherein said positioning step includes placing said graft proximate an aortic aneurism, such that said removing steps causes the superior end of said graft to be positioned superior the aneurism and the inferior end of the graft to be positioned inferior the aneurism.

10. 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.

11. The method of claim 10, wherein the placement means further includes a capsule jacket coaxially disposed over the capsule catheter such that the balloon catheter is coaxially disposed within the capsule catheter and the capsule jacket covers the graft, the proximal capsule and at least a portion of said distal capsule, said method further comprising the step of axially withdrawing the capsule jacket from the graft prior to removing the graft and anchoring means from the distal and proximal capsules.

12. 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.

13. 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.

14. The method of claim 13, wherein the deflating the balloon step is performed prior to the removing the sheath from the proximal capsule step.

15. The method of claim 13, wherein said introducing step includes providing an opening in a femoral artery and said positioning step includes placing the graft proximate an aortic bifurcation.

16. 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.

17. The method of claim 16, said method further comprising the steps of:

(n) withdrawing said capsule jacket means proximally to expose said distal capsule means, said prothesis and at least a portion of said proximal capsule means after performing step (i) and prior to performing step (j);

(o) removing the inferior end of said prosthesis from said proximal capsule means after performing step (n); and

(p) removing the superior end of said prosthesis from said distal capsule means after performing step (o) and prior to performing step (j).