Thoracic graft and delivery catheter

• US 6,346,118 B1
• Filed: 09/16/1997
• Issued: 02/12/2002
• 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: Dake, Michael D., Escano, Arnold, Dillow, David C., Baker, Steve G.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/931,323
• Time in Patent Office: 1,610 Days
• Field of Search: 623/1, 623/11, 623/12, 623/1.14, 623/1.36, 623/1.12, 623/1.23
• US Class Current: 623/1.12
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2002/9511 the retaining means being filaments or wires
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• 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

A delivery catheter having an inner catheter assembly, an inferior capsule catheter, and a capsule jacket assembly for use in deploying a graft having a compressible and expandable attachment systems in the thoracic region of an aorta. The graft is comprised of a tubular member having superior and inferior ends, each having an attachment system with wall engaging members secured thereto and is crimped along its midsection to resist kinking and elongation. The delivery catheter includes an inferior capsule assembly for releasably retaining the inferior attachment system of the graft and a superior capsule assembly for releasably retaining the superior attachment system of the graft as well as a releasing system for maintaining the attachment systems in a compressed configuration and for facilitating expansion of the attachment systems. The delivery catheter also includes an anti-elongation wire attached to the inner catheter assembly to prevent stretching of the delivery catheter during deployment of the graft within the aorta. Upon removing the attachment systems from the capsule, the releasing system functions to allow the attachment systems to assume their expanded configuration and engage the walls of the aorta. The graft and attachment systems remain in the vessel after the delivery catheter is withdrawn.

Claims

1. A system for intraluminal repair of a thoracic aortic aneurysm, comprising:

a graft having a hollow tubular body, a midsection, a single superior end and a single inferior end, said hollow tubular body having a pre-determined diameter, length and wall thickness adapted for intraluminal repair of a thoracic aortic aneurysm;

at least one attachment system, said attachment system being affixed adjacent one end of said tubular body and embodying sufficient self-expanding force such that said attachment system operates to attach said graft within a patient'"'"'s vasculature without the aid of an auxiliary device; and

a retaining system, said retaining system configured to releasably retain said superior and inferior ends in a compressed configuration while said midsection is free to expand.

2. The system of claim 1, wherein said pre-determined diameter ranges from 30-40 mm.

3. The system of claim 1, wherein said pre-determined length ranges from 7-15 cm.

4. The system of claim 1, wherein said predetermined wall thickness ranges from 0.127 to 0.229 mm.

5. The system of claim 1, wherein said tubular body includes a crimped portion said crimped portion being crimped in a manner to reduce elongation of said system while maintaining flexibility of said system.

6. The system of claim 5, wherein said crimped portion is characterized by a square wave profile.

7. The system of claim 1, wherein said retaining system includes a tie.

8. A method for placing a graft within a thoracic portion of an aorta, which comprises the steps of:

providing a graft having an attachment system secured thereto, said attachment system having a first configuration and a second configuration and embodying sufficient self-expanding force such that said attachment system operates to attach said graft within the thoracic portion of the aorta without the aid of an auxiliary device, said first configuration compressed from said second configuration;

providing a delivery catheter for receiving said graft and for placing said graft within the thoracic portion of the aorta, said delivery catheter having a releasing system cooperating with said attachment system, said releasing system including a tie and a release wire;

placing said release wire into engagement with said tie;

causing said tie to place said attachment system in said first configuration;

loading said graft within said delivery catheter;

placing said delivery catheter within the thoracic portion of the aorta;

unloading said graft from said delivery catheter; and

removing said release wire from engagement with said tie to permit said attachment system to assume said second configuration and to engage the thoracic portion of the aorta with such a force to implant said graft within the thoracic portion of the aorta without the aid of an auxiliary device.

9. A method for repairing a thoracic aortic aneurysm, which comprises the steps of:

providing a graft including a midsection, a first end and a second end and having an attachment system secured thereto, said attachment system having a first configuration and a second configuration and embodying sufficient self-expanding force such that said attachment system operates to attach said graft within the thoracic portion of the aorta without the aid of an auxiliary device, said first configuration compressed from said second configuration;

providing a delivery catheter for receiving said graft and for placing said graft within the thoracic aorta, said delivery catheter having a retaining system configured to releasably retain said ends of said graft in a compressed configuration while said midsection is free to expand;

causing said retaining system to retain said attachment system in said first configuration;

loading said graft within said delivery catheter;

placing said delivery catheter within a patient'"'"'s vasculature;

advancing said delivery catheter to the thoracic portion of the aorta;

unloading said graft from said delivery catheter in a manner to thereby allow said retaining system to retain said ends of said graft in a compressed configuration while said midsection is free to expand; and

manipulating said retaining system to implant said graft within the thoracic portion of the aorta without an auxiliary device.