Bifurcated prosthetic graft

Details Bifurcated prosthetic graft Bifurcated prosthetic graft

1998-03-16

2001-05-01

Willse, David H. (Department: 3738)

Surgery

Instruments

Means for inserting or removing conduit within body

C606S104000, C623S001230

Reexamination Certificate

active

06224609

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to a bifurcated prosthetic graft and a method for deploying the graft at an area of vessel bifurcation. The invention is a bifurcated prosthetic graft for deployment at the bifurcation of the common iliac artery, and in particular, for use with a biluminal graft system for use in repairing abdominal aortic aneurysms.
BACKGROUND OF THE INVENTION
Aortic aneurysms represent a significant medical problem for the general population. Aneurysms within the aorta presently affect between two and seven percent of the general population and the rate of incidence appears to be increasing. This form of vascular disease is characterized by a degradation in the arterial wall in which the wall weakens and balloons outward by thinning. If untreated, the aneurysm can rupture resulting in death within a short time.
The traditional treatment for patients with an abdominal aortic aneurysm is surgical repair. This is an extensive operation involving transperitoneal or retroperitoneal dissection of the aorta and replacement of the aneurysm with an artificial artery known as a prosthetic graft. This procedure requires exposure of the aorta through an abdominal incision extending from the lower border from the breast bone down to the pubic bone. The aorta is clamped both above and below the aneurysm so that the aneurysm can be opened and the prosthetic graft of approximately the same size as the aorta can be sutured in place. Blood flow is then re-established through the prosthetic graft. The operation requires a general anesthesia with a breathing tube, extensive intensive care unit monitoring in the immediate post-operative period along with blood transfusions and stomach and bladder tubes. All of this imposes stress on the cardiovascular system. This is a high-risk surgical procedure with well-recognized morbidity and mortality.
More recently, significantly less invasive clinical approaches to aneurysm repair known as endovascular grafting have been proposed. (See, Parodi, J. C., et al. “Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms,” 5 Annals of Vascular Surgery, 491 (1991)). Endovascular grafting involves the transluminal placement of a prosthetic arterial graft in the endoluminal position (within the lumen of the artery). By this method, the graft is attached to the internal surface of an arterial wall by means of attachment devices such as expandable stents, one above the aneurysm and a second below the aneurysm.
It is not uncommon for abdominal aortic aneurysms to extend to the aortic bifurcation or even into the common iliac arteries. When the aneurysm extends into the common iliac arteries it is necessary that the graft system used to repair the aneurysm extend into the common iliac arteries past the aneurysm. This requires that there be enough space between the aneurysm and the common iliac bifurcation so that the graft can properly seat. By “seating” it is meant that the graft is somehow fixed to the non-aneurysmal vasculature. However, in a significant number of patients the aneurysm extends into the common iliac arteries on one or both sides such that there is not enough room to seat the graft without at least partially blocking the internal iliac artery. Such a situation occurs in so-called Class D or E aneurysms. The internal iliac artery is a significant vessel which supplies blood to the pelvic region. Blockage of the vessel can result in undesirable consequences for the patient. For this reason, patients in this category are often excluded from the less expensive and less traumatic endovascular repair and must instead undergo the invasive surgical procedure described above.
Therefore, a need exists for an improved prosthetic graft which will allow endoluminal reconstruction of the common, external, and internal iliac bifurcation. The preferred construction will allow a bifurcated or biluminal aortic graft system to be implanted prior to or following the reconstruction of the iliac bifurcation, while maintaining blood flow to the internal iliac arteries.
SUMMARY OF THE INVENTION
In one aspect, this invention is a prosthetic graft for placement by a single delivery catheter at the bifurcation of a first vessel into second and third vessels within the vasculature of a patient comprising a first graft conduit having first and second ends and first and second stents, the first stent adapted to secure the first end of the first graft conduit within the lumen of the first vessel, the second stent adapted to secure the second end of the first graft conduit within the lumen of the second vessel; and a second graft conduit attached in fluid communication with the first graft conduit, the second graft conduit having a third stent adapted to secure it within the lumen of the third vessel, the first and second graft conduits being sized and configured to be contained within and delivered by the single delivery catheter. Preferably, the first graft conduit forms a first lumen which contains the first and second stents and the second graft conduit forms a second lumen which contains the third stent. The cross-sectional area of the first end of the first graft conduit may be greater than the cross-sectional area of the second end of the first graft conduit. The first and second graft conduits preferably are configured to expand from a first delivery configuration to a second deployed configuration. The cross-sectional area of the first end of the first graft conduit preferably is at least as great as the cross-sectional area of the prosthetic graft at any localized point along a longitudinal axis of the first graft conduit when in the delivery configuration.
In a second aspect, this invention is a method for placing a prosthetic graft in a vessel of a patient's vascular system. The prosthetic graft has a first tubular graft component and a second tubular graft component in fluid communication with it. The method comprises providing a delivery catheter containing the prosthetic graft in a first delivery configuration, the catheter having an angular control element for adjustably controlling the angle between the first and second tubular graft components; advancing the catheter through the vessel to a desired location; manipulating the angular control element to select a desired angle between the first and second tubular graft components; and deploying the prosthetic graft in the vessel in a second expanded configuration. The angular control element of the catheter may include a wire with a pre-formed angle and the step of manipulating the angular control element to select a desired angle may include advancing or retracting the wire. The first tubular graft component may include a first stent attached thereto and the second tubular graft component may include a second stent attached thereto. Preferably, the method further comprises securing the first and second tubular graft components within the vessel by radially expanding the first and second stents.
In a third aspect, this invention is a prosthetic graft for placement by a single delivery catheter at the bifurcation of a first vessel into second and third vessels within the vasculature of a patient comprising a first graft conduit having first and second ends and including a tubular graft component defining a lumen and at least one stent located within the lumen and attached to the graft component, the stent adapted to secure the first end of the first graft conduit within the lumen of the first vessel and the second end of the first graft conduit within the lumen of the second vessel; and a second graft conduit attached in fluid communication with the first graft conduit, the second graft conduit including a tubular graft component defining a lumen and a stent located within the lumen and attached to the graft component and adapted to secure the second graft component within the lumen of the third vessel, the first and second graft conduits being sized and configured to be contained within and delivered by the single delivery catheter.
In a fourth aspect, this inve

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