Artificial graft and implantation method

• US 5,104,399 A
• Filed: 03/09/1988
• Issued: 04/14/1992
• Est. Priority Date: 12/10/1986
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Lazarus, Harrison M.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US07/166,093
• Time in Patent Office: 1,497 Days
• Field of Search: 623/1, 623/2, 623/66, 623/901, 128/334 R, 128/334 C, 604/96, 606/153
• US Class Current: 623/1.14
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/958 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 2220/0058 soldered or brazed or welded
• 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 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
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An intraluminal grafting system includes a hollow graft which has a proximal staple positioned proximate its proximal end and a distal staple adapted proximate its distal end. The system includes a capsule for transporting the graft through the lumen and for positioning the proximal end of the graft upstream in a lumen which may be a blood vessel or artery. A tube is connected to the capsule and extends to exterior the vessel for manipulation by the user. A catheter is positioned within the tube to extend from the cavity and through the graft to exterior the body. The catheter has an inflatable membrane or balloon proximate the distal end thereof which is in communication via a channel with inflation and deflation means located exterior the vessel. With the inflatable membrane deflated, the capsule is positioned in the lumen and manipulated to a desired location. The inflatable membrane is manipulated by the rod away from the graft. The force exerted by the inflatable membrane and the structure of the staples urges the staples in the vessel wall, retaining the graft in position. The remainder of the intraluminal grafting system is then removed from the corporeal vessel.

Claims

1. A system for engrafting in a fluid conducting corporeal lumen comprising:

a hollow graft of preselected cross-section and length having a proximal end and a distal end for placement within said corporeal lumen, said hollow graft being deformable to substantially conform to the interior surface of said corporeal lumen;

a proximal staple positioned proximate the proximal end of said graft, said proximal staple being formed and positioned to urge said hollow graft against said interior surface and having lumen engaging members positioned and adapted for holding said proximal end of said hollow graft to and within said corporeal lumen;

a distal staple positioned proximate the distal end of said hollow graft, said distal staple being formed and positioned to urge said hollow graft against said interior surface and having lumen engaging members positioned and adapted for holding said distal end of said hollow graft to and within said corporeal lumen; and

placement means for introducing and carrying said hollow graft with said proximal staple and said distal staple into and within said corporeal lumen and for placing and engrafting said hollow graft with said proximal and distal staples at a preselected position within and to said corporeal lumen by advancing the hollow graft to the preselected position, said placement means including a cylindrical capsule sized and shaped for positioning in and movement through said corporeal lumen and formed to have an interior sized and shaped to receive said hollow graft with said proximal and distal staples, said cylindrical capsule having proximal and distal extremities, said distal extremity having an aperture formed therein for passage therethrough of said hollow graft with said proximal and distal staples.

2. The system of claim 1 wherein said placement means also includes:

operation means connected to the distal extremity of said capsule and having portions thereof which extend exterior of said corporeal lumen for manipulation by a user for urging said hollow graft and said distal and proximal staples through said aperture of said capsule.

3. The system of claim 2 wherein said operation means includes a hollow tube connected to the distal extremity of said capsule, said hollow tube being of a length to extend exterior the lumen for manipulation by the user.

4. The system of claim 3 wherein said operation means includes a catheter sized in cross section to slide within said hollow tube and through said capsule, said catheter having a length to extend from interior said capsule to exterior the lumen for manipulation by the user, and said catheter having an inflatable member proximate its interior end and means in communication therewith extending to the exterior of the lumen for inflating and deflating said inflatable member.

5. The system of claim 4 wherein said operation means includes pusher means secured to the catheter proximate to and rearward of said inflatable member for engaging and urging said hollow graft with said proximal and distal staples out of said capsule through said aperture at the proximal extremity when a pushing force is applied to the catheter.

6. The system of claim 5 wherein said pusher means is cylindrical in shape.

7. The system of claim 5 wherein said capsule has a tapered proximal extremity.

8. The system of claim 5 wherein said hollow graft is substantially cylindrical in shape and wherein said proximal and distal staples and said hollow graft are slidably positionable within said capsule, and wherein said pusher means is sized to contact said proximal staples for urging said proximal staples and said hollow graft from said capsule upon movement of said catheter relative to said first hollow tube.

9. A system for engrafting in a fluid conducting corporeal lumen comprising:

a deformable hollow graft of preselected cross-section and length having a proximal end and a distal end for placement within said corporeal lumen, said hollow graft being deformable axially and radially to substantially conform to the interior surface of said corporeal lumen;

proximal staple means positioned proximate the proximal end of said graft, said proximal staple means being formed of a spring-like material to urge said hollow graft against said interior surface of the corporeal lumen and having at least one lumen piercing member adapted to engage said corporeal lumen;

said proximal staple means being movable between a first condition in which it is compressed about a central axis and a second condition in which it is decompressed and springs outwardly from said central axis and

distal staple means positioned proximate the distal end of said hollow graft, said distal staple means being formed of a spring-like material to urge said hollow graft against said interior surface of the corporeal lumen and having a lumen member adapted to engage said corporeal lumen; and

placement means carrying said hollow graft with its proximal and distal staple adapted thereto for placing and engrafting said hollow graft at a preselected positioned within said to said corporeal lumen.

10. For engrafting a corporeal lumen, a system comprising;

a hollow graft for placement within said corporeal lumen having a preselected length and a cross-section proximate the cross-section of said corporeal lumen, said hollow graft having a proximal end and a distal end and being deformable to substantially conform to the interior surface of said corporeal lumen;

proximal staple means made of a spring-like material movable between a first condition in which it is compressed about a central axis and a second condition in which it is decompressed and springs outwardly from said central axis, said proximal staple means having a plurality of lumen piercing members and being positioned proximate said proximal end of said hollow graft to urge the said hollow graft against the interior surface of said corporeal lumen and to urge said lumen piercing members through said hollow graft and into said corporeal lumen;

distal staple means made of a spring-like material movable between a first condition in which it is collapsed about a central axis and a second condition in which it is decompressed and spring outwardly from said central axis, said distal staple means having a plurality of lumen piercing members and being positioned proximate the distal end of said hollow graft to urge the said hollow graft against the interior surface of said corporeal lumen and to urge said lumen piercing member through said hollow graft and into said corporeal lumen;

a capsule sized to receive said hollow graft and said proximal staple and said distal staple each in its first condition and positioned within said hollow graft, said capsule having a proximal extremity with an opening therein, said capsule being sized for transport through said corporeal lumen; and

means mechanically coupled to said capsule for positioning said capsule within said corporeal lumen and for causing relative movement between the capsule and the hollow graft whereby said hollow graft with said proximal and distal staples adapted thereto are urged out of said capsule for releasing said distal and proximal staple means for movement to their respectively second conditions.