Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Made of synthetic material
Reexamination Certificate
2001-10-25
2004-11-09
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Made of synthetic material
Reexamination Certificate
active
06814754
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to woven tubular grafts having selected regions of varying flexibility and particularly to woven bifurcated tubes for use as endoluminal grafts in the treatment of vascular aneurysms.
BACKGROUND OF THE INVENTION
A vascular aneurysm is a pathologic dilation of a segment of a blood vessel which constitutes a weakened portion of the vessel.
FIG. 1
shows an example of a fusiform aneurysm
10
, such as can occur in the abdominal aorta
12
. The entire circumference of the aorta
12
is dilated and weakened. The majority of these aortic aneurysms are located in the distal abdominal aorta between the renal arteries
14
and the bifurcation point
16
where the abdominal aorta splits into the common iliac arteries
18
.
An aneurysm in any vascular vessel is a cause of concern, and aortic aneurysms in particular constitute a serious condition, as an acute rupture of the aneurysm is fatal unless an emergency operation is performed. However, even when such operations are performed in time, the mortality rate is still greater than 50%.
Modern methods of treatment for aneurysms focus on preventing rupture by providing a stent graft which is positioned within the artery at the aneurysm. As seen in
FIG. 1
by way of example, a stent graft
20
comprises a bifurcated fabric tube
22
. Bifurcated fabric tubes are formed of a plurality of interlaced yarns wherein a single tube branches into two or more tubes at a bifurcation point. The term “yarn” as used herein is a generic term for a continuous strand or strands of fibers, filaments or material in a form suitable for knitting, weaving, braiding or otherwise intertwining or interlacing to form a fabric. Various forms of yarn include monofilaments, filaments twisted together, filaments laid together without twist, as well as other configurations.
Tube
22
may be woven, knitted or braided and has one end
24
which is attached to the inner surface of the artery upstream of the aneurysm
10
. The opposite end
26
of the bifurcated tube is split at a septum
28
into two branch tubes
26
a
and
26
b
. The branch tubes are attached to the inside surfaces of the iliac arteries
18
below the aneurysm
10
. The stent graft
20
is substantially impermeable to blood and replaces the abdominal aorta in the region of the aneurysm
10
, relieving the pressure on the weakened arterial wall and avoiding a potentially fatal rupture.
For endoluminal stent grafts, which are implanted in the artery through the use of a catheter, woven tubes are preferred because the graft should have as little bulk as possible so that it may be readily collapsible to fit within the lumen of the catheter. As noted above, the graft must also be substantially impermeable in the region of the aneurysm so as to isolate and relieve the pressure on it. Woven structures inherently have relatively minimal bulk when compared to knitted or braided structures having the same dimensions and can readily form a substantially impermeable membrane with low porosity. Because bifurcated grafts, with their multiple tubes, tend to be bulkier than grafts comprising a single tube, the woven structure which minimizes the bulk is especially advantageous.
The advantages of small bulk and low porosity for woven endoluminal grafts are obtained at a significant disadvantage in that the woven tube is generally unable to stretch elastically in either the radial or longitudinal directions. The lack of flexibility is inherent in woven fabrics due to the limited relative motion afforded to the yarns, which are substantially locked in place due to the nature of the weave and the requirement of impermeability. The lack of flexibility results in the disadvantages described below for the example of the woven bifurcated tube used as a graft for the repair of an aortic aneurysm. It is understood that the examples provided below apply to other than bifurcated tubes in the repair of other types of aneurysms as well.
Blood vessels are seldom round in cross-section; they tend to be oval, egg-shaped or have irregular shapes due to calcified deposits formed on the inner walls. The woven bifurcated tube must sealingly join the vessel at both its ends, but the lack of radial flexibility inhibits the ability of the tube to adapt to the non-round cross section of the vessel. As shown in
FIG. 2
, this may result in folds
30
in either or both the vessel
12
and the tube
22
where they are joined at upstream end. The folds can result in leakage of blood past the graft at its upstream end and into the aneurysm, placing pressure on the aneurysm and possibly causing it to burst.
Blood vessels are seldom straight; they tend to curve in complex ways. This is readily apparent in bifurcated vessels such as the abdominal aorta
12
which in which branches
26
a
and
26
b
curve away into the iliac arteries
18
supplying blood to the lower extremities. The lack of longitudinal flexibility inhibits the woven graft from readily bending to follow the curvature of the iliac arteries as they branch away from the aorta. As seen in
FIG. 3
, the branch
26
a
of the woven tube
22
may tend to buckle and bunch up on the inside part of the curve, causing folds
32
which can occlude the lumen of the graft, restricting blood flow. The part of the branch
26
a
on the outside of the curve does not stretch to accommodate the longer path of the artery wall and tends to tug on the artery, perhaps causing a kink
34
in its wall.
Blood vessels tend to vary in diameter from person to person depending on the physical characteristics of the individual. Due to their inherent lack of radial flexibility, woven tubes of one particular diameter cannot readily adapt to the range of artery sizes among different people. As shown in
FIG. 4
, if the tube
22
is too small in diameter, it may cause folds
36
in the artery
12
, reducing the blood flow and causing leaks past the joint. If the tube is too large, it may tend to form an inward fold
38
and leak, as seen in FIG.
5
. Therefore, many sizes of grafts must be available so that the appropriate size may be matched to a particular artery size so that a good seal can be obtained between graft and artery.
Blood vessels tend to enlarge in diameter with the age of the patient. The woven tube
22
generally does not have sufficient radial flexibility to accommodate the expansion of the vessel
12
and may result in a separation
40
of a portion of the graft from the wall of the vessel as seen in FIG.
6
. This may allow leakage into the aneurysm, and in extreme cases the upstream portion of the tube may fold into the lumen, inhibiting the flow of blood through the vessel.
Woven tubes with little radial or axial elasticity tend to be stiff. This stiffness directly affects the force required to move the stent graft through the lumen of a catheter for positioning the graft within the artery at the aneurysm. The catheter is seldom straight as it must follow the bends and twists of the vessel through which it snakes, and the stiffer the graft is, the more force is required to move it through a twisting catheter lumen.
There is clearly a need for an endoluminal graft which has minimal bulk so that it will fit within the lumen of a catheter, is substantially impermeable and strong enough to withstand repeated hydraulic pressure cycles caused by hundreds of thousands of heart beats and yet possesses the radial and longitudinal flexibility, allowing it to move with minimal force through a curving catheter and to sealingly accommodate arteries of various shapes, sizes and curvatures without folding or kinking in order to form and maintain a fluid-tight seal between the graft and the artery in the treatment of aneurysms.
SUMMARY AND OBJECTS OF THE INVENTION
The invention concerns a graft compatible with living tissue, the graft comprising an elongated tube woven from a plurality of warp yarns oriented in a warp direction substantially lengthwise along the tube and a plurality of fill yarns oriented in a fill direction substantially circumferentially around the t
Secant Medical, LLC
Synnestvedt & Lechner LLP
Willse David H.
LandOfFree
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