Artificial graft and implantation method

• US 6,416,535 B1
• Filed: 09/28/1999
• Issued: 07/09/2002
• Est. Priority Date: 04/06/1987
• Status: Expired due to Fees

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Lazarus, Harrison M.
• Primary Examiner(s): Snow, Bruce
• Application Number:
  US09/407,593
• Time in Patent Office: 1,015 Days
• Field of Search: 606/194, 606/195, 606/198, 623/1.11, 623/1.13, 623/1.14, 623/1.2, 623/1.23, 623/1.36
• 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 is position. The remainder of the intraluminal grafting system is then removed from the corporeal vessel.

Claims

1. A method for placing a graft into a fluid conducting corporeal lumen having an interior surface, comprising the steps of:

providing an apparatus for placement of the graft in the corporeal lumen, said apparatus including;

the graft preselected in length having first and second ends, said graft being deformable to conform substantially to a portion of the interior surface of the corporeal lumen;

a first attachment device positioned near the first end of said graft that attaches said graft against the interior surface of the corporeal lumen;

a cover having sufficient length to receive the first and second ends of said graft, said cover having a tapered terminal end forming an aperture having a cross section selected for passage of the graft;

an elongate member having a first end secured to said cover;

making an opening in the corporeal lumen sized for passing said cover therethrough;

inserting said cover into said opening and positioning the cover upstream into said corporeal lumen to a desired location by manipulating the elongate member;

operating the elongate member to release said graft and said first attachment device through said aperture and into the corporeal lumen; and

removing the cover from said corporeal lumen by manipulating the apparatus; and

closing said opening.

2. The method of claim 1, further comprising the steps of positioning a fluoroscopy device exterior the corporeal lumen, and using said fluoroscopy device to monitor the positioning of said cover and said graft.

3. A method for implanting a graft in corporeal lumen wall afflicted by an aneurysm having a first end, said graft having a first contracted shape and a second expanded shape, said graft further comprising a first attachment device and a second attachment device, said method comprising the steps of:

covering said graft to prevent the first and second attachment devices from contacting the lumen;

introducing an inflatable member and said graft into the lumen and then along the lumen until said graft reaches the aneurysm;

uncovering the first attachment device when said graft is positioned in the lumen such that the attachment device is adjacent to the first end of the aneurysm;

inflating the inflatable member to expand said graft and first attachment device;

deflating the inflatable member;

uncovering the second attachment device;

positioning the inflatable member adjacent the second attachment device;

inflating the inflatable member to expand the graft and second attachment device;

deflating the inflatable member; and

removing the inflatable member from the corporeal lumen.

4. A method for engrafting a graft into a corporeal lumen, said graft having first and second ends, said graft further having a first attachment device at the first end and a second attachment device at the second end, said method comprising the steps of:

(a) providing a delivery apparatus having a tapered leading end, wherein both the first and second ends of said graft are removably covered by said delivery apparatus;

(b) creating an opening in the lumen for passing said delivery apparatus and said graft therethrough;

(c) inserting said delivery apparatus and said graft into said opening;

(d) advancing said delivery apparatus and said graft to a desired location within the lumen;

(e) positioning said first end of said graft at a desired location within the lumen;

(f) activating said first and second attachment devices to fix the first and second ends of said graft within the lumen;

(g) removing said delivery apparatus from the lumen;

(h) closing said opening in the lumen;

wherein said delivery apparatus further comprises an inflation device for fixing said first and second attachment devices to said corporeal lumen, step (f) further comprises the steps of;

(i) positioning said inflation device within the first end of said prosthesis;

(j) inflating said inflation device to fix said first end to the lumen;

(k) deflating said inflation device;

(l) positioning said inflation device within the second end of said graft;

(m) inflating said inflation device to fix said second end to the lumen; and

(n) deflating said inflation device.

5. The method of claim 4, further comprising the step of repairing a damaged length of the lumen further having an interior cross section, said graft having a length selected to span the damaged length of the lumen and having a cross section selected to conform to the interior cross section of the lumen.

6. A method for implanting a graft in a corporeal lumen having a wall, said graft having first and second ends, said graft further having a first attachment device at the first end and second attachment device at the second end, said method comprising the steps of:

providing a placement apparatus having a cover device that receives the first and second ends of said graft and having an operation device that engages said attachment devices with the lumen;

inserting said placement apparatus into the lumen;

manipulating said placement apparatus to advance said graft to a desired position within the lumen;

removing the first end of said graft and said first attachment device from said placement apparatus;

activating said operation device to engage said first attachment device with the lumen, thereby securing the first end of said graft to the wall of the lumen;

removing the second end of said graft from said placement apparatus;

after engaging said first attachment device, positioning and activating said operation device to engage said second attachment device with the lumen, thereby securing the second end of said graft to the wall of the lumen; and

removing said placement apparatus from the lumen.

7. A method for emplacement of a graft into a corporeal lumen having a wall, said graft having first and second ends, said graft further having a first attachment device at the first end and second attachment device at the second end, said method comprising the steps of:

providing placement apparatus comprising a manipulation device, an inflation device, an inflatable membrane and a cover configured to receive said graft;

placing said graft in said cover, wherein said graft and said first and second attachment devices are removably covered by said placement apparatus;

inserting said placement apparatus into the lumen;

manipulating said placement apparatus to transport said cover through the lumen;

positioning said graft at a desired position within the lumen;

manipulating said placement apparatus to remove the first end of said graft and said first attachment device from said cover;

moving said inflatable membrane adjacent said first attachment device;

inflating said inflatable membrane to engage said first attachment device with the lumen, thereby securing the first end of said graft to the wall of the lumen;

manipulating said placement apparatus to remove the second end of said graft from said cover;

deflating said inflatable membrane;

after engaging said first attachment device, moving said inflatable membrane adjacent said second attachment device;

inflating said inflatable membrane to engage said second attachment device with the lumen, thereby securing the second end of said graft to the wall of the lumen;

deflating said inflatable membrane; and

removing said placement apparatus from the lumen.