Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Having marker
Reexamination Certificate
1997-08-01
2002-01-22
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Having marker
Reexamination Certificate
active
06340367
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to a retrievable radiopaque marker or a discrete radiopaque marker for use on an implantable endoprosthesis such as a stent.
Implantable endoprostheses including stents, stent-grafts, and grafts are used in percutaneous transluminal coronary angioplasty and in other medical procedures to repair and support diseased or damaged arteries and body lumens. Grafts are implanted to cover or bridge leaks or dissections in vessels. Stent-grafts are stents which generally have a porous coating attachment and may be implanted by percutaneous transluminal angioplasty. Unsupported grafts are porous tubes which are typically implanted by surgical cut-down.
In order to visualize the passage and placement of the implantable endoprosthesis in arteries and body lumens, many surgical procedures are performed under fluoroscopy. The surgical delivery device and implantable endoprosthesis may be visualized if they are radiopaque and offer radiographic contrast relative to the body. For example, X-ray radiation may be used to visualize surgical delivery devices and deployment of the implant in the body. Also, radiographic contrast solution may be injected into the body lumen so that the lumen may be seen in the fluoroscopic image.
In order for an implantable endoprosthesis to be radiopaque, it must be made from a material possessing radiographic density higher than a surrounding host tissue and have sufficient thickness to affect the transmission of x-rays to produce contrast in the image. Reference is made to the clad composite stent shown in U.S. Pat. No. 5,630,840. An implantable endoprosthesis may be made of metals including tantalum or platinum having relatively high radiographic densities. Other metals such as stainless steel, superalloys, nitinol, and titanium having lower radiographic densities may also be used. Reference is made to implantable devices shown in U.S. Pat. Nos. 4,655,771; 4,954,126; and 5,061,275.
An implantable polymeric endoprosthesis is generally radiolucent and does not possess sufficient radiographic density to be easily imaged by fluoroscopy. To improve the imaging of polymeric materials, polymers may be mixed with radiopaque filler materials prior to molding or extruding in order to enhance the radiographic density. However, a disadvantage of using fillers with polymers is that changes in the properties of the polymer may occur. For example, the addition of fillers may reduce the strength or ductility of the polymer.
There is a need for an improved radiopaque marker for use in medical devices, particularly in temporary medical devices having low radiopacity. The need to improve the radiopacity of a relatively low radiopaque implantable endoprosthesis or improve imaging in low radiopaque conditions is particularly important for surgery, micro-surgery, neuro-surgery, and conventional angioplasty procedures performed under fluoroscopy. Physicians are constantly being challenged to place small implants at remote intraluminal locations.
Various devices having radiopaque markers are shown in U.S. Pat. Nos. 4,447,239; 5,423,849; and 5,354,257.
All documents cited herein, including the foregoing, are incorporated herein by reference in their entireties for all purposes.
SUMMARY OF THE INVENTION
Accordingly, there is a need for retrievable radiopaque markers for use in implantable endoprostheses to improve radiopacity and the locatability of endoprostheses in various medical procedures. Providing temporary radiopacity is especially advantageous for implantable endoprostheses having little or no radiopacity. The markers allow radiographic identification of one or more locations of interest on an implantable endoprosthesis. The locations of interest may include one or more covered or coated regions.
Alternative embodiments include threading the markers adjacent a helical strand in the implantable endoprosthesis, circumferentially around the implantable endoprosthesis, in a straight line in the axial direction of the implantable endoprosthesis, or disposing the wire in the form of pigtail-shaped rings, coils, or knots around filament crossing points in the implantable endoprosthesis.
Temporary retrievable radiopaque markers in the fabric or covering materials of an implantable endoprosthesis are advantageous for indicating the location of the fabric or covering during implantation. After implantation, the temporary retrievable radiopaque marker may be retrieved so as not to effect the function of the endoprosthesis.
A disadvantage of some permanent radiopaque markers is that they may compromise structural integrity, may not be biocompatible or biostable, and may be more thrombogenic than the implantable endoprosthesis.
The temporary retrievable radiopaque marker of the present invention advantageously allows most any implantable endoprosthesis to have temporary radiopacity over a predetermined portion of its structure, and assists with proper positioning and locatability of the implantable endoprosthesis in a body lumen.
Use of temporary retrievable radiopaque markers on an implantable endoprosthesis is advantageous because the radiopaque property may be present only for a desired time period. Generally, radiopacity is most desirable during placement of the implant. Once the implantable endoprosthesis is implanted, it may be more desirable to image the device with techniques such as ultrasound, magnetic resonance, and endoscopy and avoid further radiation exposure to the patient. Temporary radiopacity may be made by incorporating non-integral, retrievable radiopaque constituents into the implant. Thus, light metals, thin radiopaque metals, polymers, and ceramics may be utilized for a wide range of properties and flexibility in design of the endoprosthesis.
Attenuation is the change in the number of photons in the incident x-ray beam due to the interaction with an absorber. To image an object implanted in the body, it would be desirable to have the object attenuate x-rays more than body tissue, bone, and fat so that the difference in contrast will be obvious in a radiograph. The difficulty in selecting a radiopaque material for surgical implants is that the material must have desirable radiographic characteristics and biocompatibility.
In order to make an implant more radiopaque, a substance which absorbs more x-rays can be deposited on or mixed in with the implant material. If the implant absorbs more x-rays than the surrounding medium (for example tissue in the body), it will be visible as a sharp change in contrast on an x-ray film or fluoroscopy image.
The fraction of x-ray energy transmitted through the absorber is quantitatively predicted by the following equation described in
The Physics of Radiology
, Fourth Ed., H. Johns, J. Cunningham, 1983, pp. 137-142.
N=N
0
e
−&mgr;x
N=number of photons transmitted through x
N
0
=number of photons in the incident beam
&mgr;=linear attenuation coefficient of the absorber
x=absorber thickness
N/N
0
would be the fraction of incident x-ray energy that is transmitted through the absorber. A more radiopaque material would have a lesser fraction of transmitted energy than a more radiolucent material. Therefore, to enhance the radiopacity of a material, such as the marker material, it would be desirable to select a material with high x-ray absorbing capability to minimize the fraction of transmitted energy. This radiopacity capability is proportional to the linear attenuation coefficient and the thickness of the absorber material. The higher the attenuation coefficient of the absorber material for a given thickness, the more radiopaque the absorber will be. The attenuation produced by an absorber is dependent upon the number of electrons and atoms present in the absorber. One way of quantifying this absorption characteristic is with the atomic attenuation coefficient which is directly proportional to the linear attenuation coefficient and the atomic number of the absorber element. Radiopacity is therefore generally proportional to the atomi
Clerc Claude O.
Stinson Jonathan S.
Boston Scientific Scimed Inc.
Larkin Hoffman Daly & Lindgren Ltd.
Milano Michael J.
Niebuhr, Esq. Frederick W.
Ryan, Esq. Andrew D.
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