Artificial graft and implantation method

• US 6,030,413 A
• Filed: 08/29/1991
• Issued: 02/29/2000
• Est. Priority Date: 12/09/1983
• 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): Weiss, John G.
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US07/752,008
• Time in Patent Office: 3,106 Days
• Field of Search: 623/1, 623/2, 623/12, 606/194, 606/108, 606/192, 604/96
• US Class Current: 623/1.11
• 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 intraluminally engrafting in a lumen formed by a wall disposed within a body, the system comprising:

a graft of preselected cross-section and length and having an interior surface, the graft being capable of assuming expanded and contracted positions;

anchoring elements carried by the graft and extending externally of the graft to engage a lumen;

catheter means for inflating the graft into the lumen and advancing the graft through the lumen to a desired location;

an inflatable member disposed within the graft;

inflation means in fluid communication with the inflatable member for radially expanding the inflatable member;

the catheter means having positioning means for causing axial movement of the inflatable member in relation to the graft;

protective means for covering the anchoring elements to prevent the anchoring elements from engaging the wall forming the lumen;

actuation means coupled to the protective means and to the graft for providing relative movement between the graft and protective means, wherein the protective means can be withdrawn from the graft so that the anchoring elements are uncovered to permit them to be moved in to engagement with the wall forming the lumen;

wherein the inflatable member when radially expanded engages the interior surface of the graft and urges the anchoring elements into engagement with a wall forming the lumen; and

wherein the graft has proximal and distal extremities and wherein the anchoring elements are disposed adjacent the proximal and distal extremities and wherein the protective means extends over the anchoring elements at the proximal and distal extremities.

2. A system for engrafting in a body lumen formed by a wall, the system comprising:

a graft configured for contracted and expanded positions;

an anchoring element having at least three support members, each support member having two legs joined to form an apex, each support member leg joined to the leg(s) of an adjacent support member to form a substantially circular arrangement of support members about a central axis;

the anchoring element operable between a first collapsed position for insertion into a body lumen and a second expanded position;

the anchoring element further having wall engaging members each attached to a selected support member;

wherein the wall engaging members are configured to extend outwardly from the central axis for engaging a wall of the body lumen when the anchoring element is in the expanded position;

an inflatable member;

shaft means affixed to the inflatable member for causing axial movement of the inflatable member in the body lumen;

the shaft means including an inflation lumen in fluid communication with the inflatable member;

a sheath covering at least a portion of the graft to prevent the anchoring element from contacting the wall of the body lumen while the graft is being advanced in the body lumen; and

inflation means coupled to the shaft means for radially expanding the inflatable member to cause radial expansion of the graft to urge the anchoring element into engagement with the body lumen.

3. A system for engrafting in a body lumen formed by a wall, the system comprising:

a graft capable of assuming contracted and expanded positions;

anchoring means for securing the graft within a body lumen;

a hollow capsule having a proximal portion configured to allow passage through the body lumen having a first end and a second end, the first end having an aperture sized for passage of the graft, the second end configured with a first connector;

the capsule further having a distal portion configured to allow passage through the body lumen and having a second connector configured to connect to the first connector of the capsule;

wherein the proximal and distal portions of the capsule when connected together are sized to removably receive the graft;

an inflatable member;

shaft means affixed to the inflatable member for causing axial movement of the inflatable member in the body lumen;

the shaft means including an inflation lumen in fluid communication with the inflatable member; and

inflation means coupled to the shaft means for radially expanding the inflatable member to cause radial expansion of the graft to urge the anchoring means into engagement with the body lumen.