Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Drug delivery
Reexamination Certificate
1999-09-03
2002-04-30
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Drug delivery
C623S001430, C623S001150, C623S023700
Reexamination Certificate
active
06379381
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to implantable devices, such as an expandable, intraluminal prosthesis commonly known as a stent. More particularly, this invention relates to a prosthesis having pores formed in its cylindrical body. Moreover, the present invention relates to a method of depositing substances, such as therapeutic substances, in the pores.
2. Description of the Background
Percutaneous transluminal coronary angioplasty (PTCA) is a procedure for treating heart disease. A catheter assembly having a balloon portion is introduced into the cardiovascular system of a patient via the brachial or femoral artery. The catheter assembly is advanced through the coronary vasculature until the balloon portion is positioned across the occlusive lesion. Once in position across the lesion, the balloon is inflated to a predetermined size to radially press against the atherosclerotic plaque of the lesion to remodel the vessel wall. The balloon is then deflated to a smaller profile to allow the catheter to be withdrawn from the patient's vasculature.
A problem associated with the procedure includes formation of intimal flaps or torn arterial linings which can collapse and occlude the conduit after the balloon is deflated. Moreover, thrombosis and restenosis of the artery may develop over several months after the procedure, which may require another angioplasty procedure or a surgical by-pass operation. To reduce the partial or total occlusion of the artery by the collapse of arterial lining and to reduce the chance of the development of thrombosis and restenosis, an intraluminal prosthesis, an example of which includes an expandable stent, is implanted in the lumen to maintain the vascular patency. Stents are scaffoldings, usually cylindrical or tubular in shape, functioning to physically hold open, and if desired, to expand the wall of the passageway. Typically stents are capable of being compressed for insertion through small cavities via small catheters, and then expanded to a larger diameter once at the desired location. Examples in patent literature disclosing stents which have been successfully applied in PTCA procedures include stents illustrated in U.S. Pat. No. 4,733,665 issued to Palmaz, U.S. Pat. No. 4,800,882 issued to Gianturco, and U.S. Pat. No. 4,886,062 issued to Wiktor.
In treating the damaged vasculature tissue and to further fight against thrombosis and restenosis, there is a need for administrating therapeutic substances to the treatment site. For example, anticoagulants, antiplatelets and cytostatic agents are commonly used to prevent thrombosis of the coronary lumen, to inhibit development of restenosis, and to reduce post-angioplasty proliferation of the vascular tissue, respectively. To provide an efficacious concentration to the treated site, systemic administration of such medication often produces adverse or toxic side effects for the patient. Local delivery is a highly suitable method of treatment in that smaller levels of medication, as compared to systemic dosages, are concentrated at a specific site. Local delivery produces fewer side effects and achieves more effective results.
One commonly applied technique for the local delivery of the drugs is through the use of medicated stents. One proposed method of medicating stents is to seed the stent with endothelial cells (Dichek, D. A. et al. Seeding of Intravascular Stents With Genetically Engineered Endothelial Cells; Circulation 1989; 80: 1347-1353). Briefly, endothelial cells can be seeded onto stainless steel stents and grown until the stents are covered. The cells are therefore able to be delivered to the vascular wall to provide therapeutic proteins. Another proposed method of providing therapeutic substances to the vascular wall includes simple heparin-coated metallic stent, whereby a heparin coating is ionically or covalently bonded to the stent. Disadvantages associated with the aforementioned methods include significant loss of the therapeutic substance from the body of the stent during delivery and expansion of the stent and an absolute lack of control of the release rate of the therapeutic substance from the stent. Another proposed method involves the use of a polymeric carrier coated onto the body of the stent, as disclosed in U.S. Pat. No. 5,464,650 issued to Berg et al., U.S. Pat. No. 5,605,696 issued to Eury et al., U.S. Pat. No. 5,865,814 issued to Tuch, and U.S. Pat. No. 5,700,286 issued to Tartaglia et al. Obstacles often encountered with the use of a polymeric coating include difficulties in coating a complicated geometrical structure, poor adhesion of the polymeric coating to the surface of a stent, and biocompatibility of the polymer. Accordingly, it is desirable to be able to secure the therapeutic substance directly onto the body of the stent. Not withstanding the benefits gained by securing a therapeutic substance to the body of the stent, it is also desirable to be able to secure other substances to the body of the stent, such as radiopaque materials, used to assist a physician to guide and deploy the stent at the proper site of treatment.
SUMMARY OF THE INVENTION
In accordance with various aspects of the present invention, an implantable prosthesis, one example of which includes a stent, is provided that is capable of being loaded with substances. The prosthesis is defined by a cylindrical shaped body having a thickness. Depots or pores are formed on the body at preselected locations. The depots have a preselected depth and shape. The depth of the depots can be equal to about 10% to about 90% of the thickness. In one embodiment, the depots can have a cylindrical shape. In another embodiment, the shape can be generally conical. Substances such as therapeutic substances, polymeric material, polymeric material containing therapeutic substances, radioactive isotopes, and radiopaque material can be deposited into the depots.
Another aspect of the present invention is a method of loading a substance into the depots. The method is applicable not only to the above-described prosthesis, but to any type of porous prosthesis. A first fluid having a substance added therein is applied to a porous prosthesis. During the application, the first fluid containing the substance is capable of penetrating into the pores. The first fluid is removed, for example by evaporation, and a second fluid is applied to the prosthesis. During the application of the second fluid, the second fluid is not capable of significantly penetrating into the pores. The second fluid can have a contact angle greater than about 90°. Contact angle is defined as the angle at the tangent of the fluid phase that has taken an equilibrium shape on a solid surface. In one embodiment of the present invention, the second fluid rinses the substance from the surface of the body of the prosthesis. In another embodiment, a therapeutic substance and/or a polymer can be added to the second fluid to form a coating of a therapeutic substance and/or polymer onto the surface of the body of the prosthesis.
In accordance to another embodiment, prior to the application of the second fluid, the prosthesis can be immersed in a third fluid and agitated via mechanical perturbation techniques. Accordingly, any of the substance gathered on the surface of the body after the application of the first fluid is removed. The third fluid should not be capable of dissolving the substance. The third fluid can have a contact angle above 90°.
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Chen Li
Hossainy Syed F. A.
Advanced Cardiovascular Systems Inc.
Cameron Kerrigan Squire, Sanders and Dempsey, L.L.P.
Chattopadhyay Urmi
Isabella David J.
LandOfFree
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