Stent-graft-membrane and method of making the same

Details Stent-graft-membrane and method of making the same Stent-graft-membrane and method of making the same

2000-10-10

2004-03-23

McDermott, Corrine (Department: 3738)

Prosthesis (i.e., artificial body members), parts thereof, or ai

Arterial prosthesis

Having built-in reinforcement

C623S001130

Reexamination Certificate

active

06709455

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a stent-graft-membrane for placement at a treatment site within a body vessel or organ to enhance and direct fluid flow therethrough and a method of making the same. More particularly, the invention relates to an implantable endoprosthesis such as a stent combined with a generally impermeable membrane layer and a permeable graft layer. The graft and the membrane provide biocompatibility with tissue at the treatment site and provide biocompatibility with fluid in the lumen.
BACKGROUND OF THE DISCLOSURE
Intraluminal implantable endoprostheses such as self expanding stents, grafts and stent-grafts are known and are, for example, shown in U.S. Pat. Nos. B1 4,954,126; 5,116,360; 5,133,742; 5,591,226; 5,653,747; and 5,679,470. A covered stent is described in International Publication Number WO 94/24961. A polyurethane is described in U.S. Pat. No. 4,810,749. A porous implantable material is described in U.S. Pat. No. 4,475,972. A method of forming an implantable graft is described in U.S. Pat. No. 4,738,740.
U.S. Pat. No. B1 4,655,771, entitled, Prosthesis Comprising Expansible or Contractile Tubular Body, discloses a prosthesis comprising a flexible tubular body for tansluminal implantation.
U.S. Pat. No. 5,061,275, entitled, Self-Expanding Prosthesis, discloses a resilient, elastic self-expanding prosthesis comprising a flexible tubular body.
U.S. Pat. No. 5,645,559, entitled, Multiple Layer Stent, discloses a radially self-expanding stent having multiple layers that includes a medial region and proximal and distal cuffs having diameters greater than the medial region diameter when the stent is in the relaxed state. A silicone coating circumscribes at least the medial region of the stent.
U.S. Pat. No. 5,718,159, entitled, Process for Manufacturing Three-Dimensional Braided Covered Stent, discloses a prosthesis having a flexible tubular three-dimensionally braided structure of metal or polymeric non-filaments, and polymeric multifilament yarns.
U.S. Pat. No. 5,741,333, entitled, Self-Expanding Stent For A Medical-Device To Be Introduced Into A Cavity Of A Body, discloses a self-expanding stent.
U.S. Pat. No. 5,755,774, entitled, Bistable Luminal Graft Endoprosthesis, discloses a luminal graft endoprosthesis or endovascular graft which is capable of dilation and support functions and suitable for the endoluminal repair of vascular lesions and the like. An expandable support or stent is combined with a tubular graft made of a material having two unstressed conditions to provide a combined stent-graft wherein the graft material is secured to either or both of the internal or external surfaces of the stent.
U.S. Pat. No. 5,534,287, entitled, Methods for Applying an Elastic Coating Layer on Stents, discloses a coated stent comprising a cylindrical wall formed by meshed wires and a covering layer of elastic material extending on a portion of its length, with an outer surface, and totally embracing the wire mesh.
U.S. Pat. No. 4,850,999, entitled, Flexible Hollow Organ, discloses a flexible hollow organ, especially a vascular prosthesis intended for implantation in the human or animal body parts. The hollow organ includes a flexible prosthetic tube serving for a throughflow of a medium or which consists of such a prosthetic tube. A wall of the prosthetic tube exhibits at least one braided hose of flexible, elastic threads produced as a hollow meshwork.
A stent-graft is described in U.S. patent application Ser. No. 08/640,253, entitled “Cobalt-Chromium-Molybdenum Alloy Stent and Stent Graft”, filed Apr. 30, 1996.
A stent-graft is described in U.S. patent application Ser. No. 08/993,985, entitled, Stent-Graft with Bioabsorbable Structural Support, filed Dec. 18, 1997.
A stent-graft is described in U.S. patent application Ser. No. 08/946,906 entitled, Stent-Graft with Braided Polymeric Sleeve, filed Oct. 8, 1997.
All references cited herein are incorporated herein by reference in their entireties for all purposes.
SUMMARY OF THE INVENTION
The stent-graft-membrane of the present invention has at least three layers and is intended for treatment of vascular lumens, non-vascular lumens or organs in the body. The three lavers include a structural stent laver a raft laver and a membrane laver. The three layers may be formed in different combinations of layers. A need exists for a stent-graft-membrane of the present invention having layers with surfaces that are selected to be biocompatible with the tissue or fluid for which they are associated with while treating vessels or organs. Biocompatibility means that the implant is accepted by the host tissue and does not create an adverse biological response.
The stent-graft-membrane may advantageously be used in a variety of medical applications including intravascular treatment of stenoses, aneurysms or fistulas; maintaining openings in the urinary, biliary, tracheobronchial, esophageal, renal tracts, vena cava filters; repairing abdominal aortic aneurysms; or repairing or shunting damaged or diseased organs.
In sum, the invention relates to an implantable endoprosthesis including a first number of elongated members wound helically in a first common direction and crossing a second number of elongated members wound helically in a second common direction. The crossing of the first and second elongated members define an angle and form a generally tubular body having an inside surface, outside surface, ends and a middle portion. The first and second elongated members are braided in a braid pattern and are configured to be constrainable to a reduced diameter and self-expandable to an increased diameter. The tubular body is disposed at a treatment site in a body vessel or organ having body tissue. A passage extends in a longitudinal direction at least partially through the generally tubular body. The passage at least partially contains a fluid in the lumen and directs flow. One or more outside layers are disposed over or on at least a portion of the outside surface of the tubular body. An outermost layer of the one or more outside layers is biocompatible with the body tissue. One or more inside layers are disposed over or on at least a portion of the inside surface of the tubular body. An innermost layer of the one or more inside layers is biocompatible with the fluid in the passage. At least one of the one or more outside layers or the one or more inside layers are substantially impermeable to fluids. The inside layer or the outside layer may each include one or more layers. The one or more inside and outside layers may include one or more membrane layers having an average permeability ranging from about 0 cc/cm
2
/min. to about 100 cc/cm
2
/min. and/or one or more graft layers having an average permeability ranging from about 50 cc/cm
2
/min. to about 5000 cc/cm
2
/min. The outside layer may be a film or membrane made of silicone or polycarbonate urethane and the inside layer may be a graft made of braided PET. The inside layer may be ePTFE or PTFE. The implantable endoprosthesis may be designed to provide structural structural support to a body vessel for a period of time and substantially separate a first body fluid located outside the endoprosthesis from a second body fluid located in the passage. The implantable endoprosthesis may be disposed at a Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment site. At a TIPS treatment site, the first fluid may include bile and the second fluid may include blood. The braided implantable endoprosthesis may include an opening defined by each end of the generally tubular body. The tubular body may be made of metal, plastic, bioabsorbable or other synthetic or natural materials. The tubular body may have a braid angle or filament crossing angle of between about 65 degrees and 155 degrees.
The invention also relates to an implantable endoprosthesis including a first set of filaments each of which extends in a configuration along a center line and having a first common direction of winding. A second set of filaments each extends in a configuration alon

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