Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
1997-12-03
2001-09-18
Milano, Michael J. (Department: 2165)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
Reexamination Certificate
active
06290729
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is generally in the area of methods of treating tissue defects and modulating cell to cell interactions by administration of a polymeric gel material containing bioactive molecules to a tissue surface.
The hollow or tubular geometry of organs commonly has functional significance, for example, in the facilitation of fluid or gas transport (blood, urine, lymph, oxygen or respiratory gases) or cellular containment (ova, sperm). Disease processes may affect organ tissue or its components by encroaching upon, obstructing or otherwise reducing the cross-sectional areas of the hollow or tubular elements. Additionally, other disease processes may violate the native boundaries of the hollow organ and thereby affect its barrier function and/or containment lability. These disease processes include those which are induced by aging, diet, injury, or activation of the coagulation, complement and other inflammatory systems or the development of a neoplasia or malignancy. The ability of the organ or structure to properly function can then be severely compromised.
This is particular evident in coronary artery disease, where initial successful treatment may subsequently be complicated by overproliferation of endothelium, called restenosis, or vessel renarrowing or closing after dilation.
The types of problems associated with angioplasty are also characteristic of similar treatment of other types of natural lumens, including surgical correction and balloon dilation of urinary and reproductive tract disorders, for example, following prostate surgery, or treatment by laparoscopy of the fallopian tubes, as well as treatment of openings arising from disease, surgery and trauma. Further, these reobstructive problems also occur in artificially or therapeutically created lumens or pathways, such as in renarrowing of the intrahepatic shunt formed in transjugular intrahepatic portosystemic shunting procedure (TIPS).
As described in the literature, for example, U.S. Pat. No. 5,213,580 to Slepian, pre-formed polymeric materials can be inserted into blood vessels and then contoured to fit the surfaces of the vessels, providing protection of the blood vessel and prevention of restenosis. As described in U.S. Pat. Nos. 5,126,141 and 5,135,751 to Henry, et al., aqueous, thermally reversible gel compositions formed of a polyoxyalkylene polymer and an ionic polysaccharide can be applied to injured areas of the body to prevent adhesions. These same type of polyoxyalkylene polymers have also been used for the local delivery of oligonucleotides (antisense) to the surgically exposed surface of blood vessels for treatment of restenosis, as described by WO93/01286 by Rosenberg, et al.
None of these, however, describe a means for forming a polymeric material at or on a lumen surface which can be used as a barrier of controlled permeability or for controlled delivery of a bioactive substance, nor can these materials be targeted to a particular cell type. While the prior art discloses useful treatments of damaged lumen surfaces, it would be desirable to have materials which could provide these additional useful functions, especially controlled permeability which would allow free exchange of gases and nutrients or controlled diffusion of macromolecules which are beneficial to the lumen surface, as well as for controlled drug delivery to the surface, for example, of growth factors or antiinflammatories.
It is therefore an object of the present invention to provide polymeric materials which are initially amorphous, biocompatible, and can be formed in situ.
It is a further object of the present invention to provide polymeric materials of controlled permeability which can be used as selective barriers on lumen surfaces.
It is a still further object of the present invention to provide materials which can be used for controlled delivery of drugs and other biologically active substances, either to tissue lumen surfaces or into the lumens themselves.
SUMMARY OF THE INVENTION
Methods for creating in situ specific local interactions of cellular interactions in living tissue are disclosed. This is accomplished by applying a fluent material which forms a local, selectively permeable barrier, alone or in combination with specific bioactive molecules, directly to a site to be treated. Upon application, the fluent material is conformed to the tissue and converted to a less fluent state by alteration in temperature, ion concentration, application of shear force, or chemical or physical polymerization or crosslinking. In one embodiment, cellular interactions, such as formation of thrombus, inflammation, or adhesions, are inhibited by physically blocking cellular and/or macromolecular interactions while allowing selective permeability to nutrients, gases, and other molecules. Permeability is controlled by selection of the material, method of manufacture, density, degree of crosslinking, molecular weight of monomer units, incorporation of particulate or other material, and degradability or non-biodegradability of the polymeric material. In another embodiment, the polymeric gel is provided in combination with bioactive molecules, especially those providing contact guidance, or chemotactic or haptotactic activity, which can be utilized to alter cell proliferation, migration, and inflammatory reactions.
As demonstrated by the examples, a synthetic barrier made of a biocompatible polymeric material can be applied in vivo to a tissue or cellular surface such as the interior surface of a blood vessel or tissue lumen. The material may also be applied to tissue contacting surfaces of implantable medical devices. The polymeric material is applied in the first fluent state to the site to be treated using, for example, a catheter, or by means of spraying or irrigation at the time of surgery. The material is then reconfigured to have intimate conforming contact with the surface to be coated, and then maintained under conditions which convert the material into its second non-fluent state. The conversion may be achieved either by active methods in which the environment surrounding the material is altered by the addition or removal of chemicals or energy, or it may be by passive means in which, for example, maintaining the material at the normal internal body temperature of the patient causes the material to undergo conversion into its non-fluent state. The transition of the material from a fluent state to a non-fluent state may be the result of a phase change in which the material goes from a liquid state to a solid state, by gelation, or in the alternative, it may be the result of a viscosity change with the material actually remaining in a single phase.
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Massia Stephen P.
Slepian Marvin J.
Arnall Golden & Gregory LLP
Endoluminal Therapeutics, Inc.
Milano Michael J.
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