Intra vascular implant and method of manufacture thereof

Surgery – Instruments – Internal pressure applicator

Patent

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A61M 2900

Patent

active

061496650

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The present invention is directed to an implant for the circulatory system of a warm blooded animal and a method of manufacture thereof. More specifically, the present invention is directed to an implant for the circulatory system of a warm blooded animal which will minimize or prevent short-term failure and a method of manufacturing such implant.


BACKGROUND OF THE INVENTION

One of the major cardiovascular problems afflicting human beings is the build-up of plague on the inside of blood vessel walls. This narrows the passage for blood and, in more extreme cases, even closes it off entirely.
One of the common treatments is the use of angioplasty. In this method, an inflatable balloon on the end of a catheter is inserted into the blood vessel and inflated at the point of plaque build-up, thereby dilating the artery or vein. However, this procedure provides only temporary relief. The blood vessel tends to return to its original condition within a relatively short period.
To overcome this problem, the procedure has been modified to include the use of a mesh-type metal stent. The stent is crimped around the balloon portion of the catheter and inserted into the blood vessel along with it. The stent has sufficient yieldability so that, when the balloon is inflated, the stent is expanded (see FIG. 1) into contact with the blood vessel walls. The balloon is then deflated and removed, leaving the stent in place. This is a definite improvement over the prior procedure, but is by no means completely satisfactory. In actuality, about 25% to 30% of such stents occlude within six months. This is the result of cellular proliferation whereby the cells grow through the spaces in the grid of the stent, thus developing the blockage anew.


SUMMARY OF THE INVENTION

A first embodiment of the present invention is directed to a method of making an implant for a circulatory system of a warm blooded animal. The method includes surrounding an inert shaft with a flexible membrane. The flexible membrane is contacted with glutaraldehyde to produce a tanned membrane. The flexible membrane is removed from the inert cylinder and placed around an inner expandable stent. Preferably, the stent is releasably attached about a balloon portion of a catheter so that, upon inflation of the balloon portion of the catheter, the stent and membrane are expanded.
Another embodiment of the present invention is directed to an implant for introduction into a circulation system of a warm blooded animal. The implant includes an expandable stent. A flexible membrane, compatible with said warm blooded animal, is mounted about said stent.
Yet another embodiment of the present invention is directed to an implant for introduction into a circulatory system of a warm blooded animal. This embodiment is similar to the implant described above with the addition of an outer stent surrounding the flexible membrane.


BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, constituting a part hereof, and in which like reference characters indicate like parts,
FIG. 1 is side elevation of a stent mounted over a balloon catheter;
FIG. 2A is a perspective view of a membrane surrounding a wire;
FIG. 2B is a perspective view of the membrane of FIG. 2A after being twisted relative to the wire;
FIG. 3 is a view,,similar to that of FIG. 2B, after the wire has been removed;
FIG. 4A is a side elevation of a stent;
FIG. 4B is side elevation of an implant in accordance with the present invention;
FIG. 5 is a schematic view showing implant of FIG. 4B on a catheter; and
FIG. 6 is a side elevation of an implant in accordance with another embodiment of the present invention.


DESCRIPTION OF PREFERRED EMBODIMENT

FIGS. 1-4B illustrate the steps for fabricating an implant 10 in accordance with the present invention. The implant 10 advantageously provides the structural reinforcement of conventional stents with the ability to prevent, minimize, or substantially delay the perforation of cells and reformation of blood vessel blockage.
FIG. 1 illustrates a stent

REFERENCES:
patent: 4990131 (1991-02-01), Dardik et al.
patent: 5380299 (1995-01-01), Fearnot et al.
patent: 5645581 (1997-07-01), Zurbrugg

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