Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Reexamination Certificate
1999-02-19
2001-07-17
Milano, Michael J. (Department: 2165)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
C623S001400, C623S001390
Reexamination Certificate
active
06261320
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to coated or covered intraluminal stents and grafts that are adapted to be advanced in a collapsed roll to the site of an aneurysm, defect or injury of a body vessel and expanded or allowed to self expand across the site, wherein said coating or covering comprises at least one radioisotope.
BACKGROUND OF THE INVENTION
PTA treatment of the coronary arteries, percutaneous transluminal coronary angioplasty (PTCA), also known as balloon angioplasty, is the predominant treatment for coronary vessel stenosis. Approximately 300,000 procedures were performed in the United States in 1990 and nearly one million procedures worldwide in 1997. The U.S. market constitutes roughly half of the total market for this procedure. The increasing popularity of the PTCA procedure is attributable to its relatively high success rate, and its minimal invasiveness compared with coronary by-pass surgery. Patients treated by PTCA, however, suffer from a high incidence of restenosis, with about 35% or more of all patients requiring repeat PTCA procedures or by-pass surgery, with attendant high cost and added patient risk.
More recent attempts to prevent restenosis by use of drugs, mechanical devices, and other experimental procedures have had limited long term success. Stents, for example, dramatically reduce acute reclosure, and slow the clinical effects of smooth muscle cell proliferation by enlarging the minimum luminal diameter, but otherwise do nothing to prevent the proliferative response to the angioplasty induced injury.
Restenosis is now believed to occur at least in part as a result of injury to the arterial wall during the lumen opening angioplasty procedure. In some patients, the injury initiates a repair response that is characterized by hyperplastic growth of the vascular smooth muscle cells in the region traumatized by the angioplasty. Intimal hyperplasia or smooth muscle cell proliferation narrows the lumen that was opened by the angioplasty, regardless of the presence of a stent, thereby necessitating a repeat PTCA or other procedure to alleviate the restenosis.
Preliminary studies indicate that intravascular radiotherapy (IVRT) has promise in the prevention or long-term control of restenosis following angioplasty. IVRT may also be used to prevent or delay stenosis following cardiovascular graft procedures or other trauma to the vessel wall. Proper control of the radiation dosage, however, appears to be important to inhibit or arrest hyperplasia without causing excessive damage to healthy tissue. Overdosing of a section of blood vessel can cause arterial necrosis, inflammation, hemorrhaging, and other risks discussed below. Underdosing will result in inadequate inhibition of smooth muscle cell hyperplasia, or even exacerbation of hyperplasia and resulting restenosis.
U.S. Pat. No. 5,059,166 to Fischell discloses an IVRT method that relies on a radioactive stent that is permanently implanted in the blood vessel after completion of the lumen opening procedure. Radiation delivery systems provided on a stent have also been disclosed in U.S. Pat. No. 5,176,617 to Fischell et al., and in U.S. Pat. No. 5,674,177 to Heirlein et al. The use of a stent as a platform is of particular interest because it has been shown to be effective in animals, even at activity ranges as low as 0.14-0.23 &mgr;Ci (microcuries). Refer, for example, to Fischell, et al.,
A
Low-Dose, &bgr;-Particle Emission From Stent Wire Results in Complete, Localized Inhibition of Smooth Muscle Cell Proliferation”,
Circulation
, vol. 90, pp. 2956-2963, (1994); Laird et al,
A
Inhibition of Neointimal Proliferation with Low-Dose Irradiation From a &bgr;-Particle-Emitting Stent”,
Circulation
, 93:529-536 (1996); Carter, et al,
A
Effects of Endovascular Radiation From a &bgr;-Particle Emitting Stent in a Porcine Coronary Restenosis Model [A Dose-Response Study]@,
Circulation
92:1570-1575 (1995); and Hehrlein, et al,
A
Pure &bgr;-Particle-Emitting Stents Inhibit Neointima Formation in Rabbits”,
Circulation
93:641-645 (1996).
Several limitations exist in the systems disclosed in the literature and in the currently available art. One limitation is that the isotope chosen for the radiation is dependent on the materials used for the stent. For example, in the systems described in Fischell '617 and '166, Hehrlein '177, and in the stents used in the experiments described by Fischell and Hehrlein in their 1995 papers cited above, the active isotopes were limited to species created by direct neutron activation of the stent in a reactor. This process limits control over the type and amount of radiation that the stent can possess. Hehrlein '177 discloses no less than nine different isotopes created by this process, each with its own half-life, activity level, and radiation characteristics. This set up makes control over the radiation dose extremely difficult, and investigation into the interaction of the radiation with tissue very problematic.
To overcome this limitation, the stents used in the study described by Laird were made by first ion implanting the stent with phosphorous-31 (P-31 or
31
P), then placing the stents in a reactor to convert the stable P-31 to the beta-emitting P-32. Alternatively, the radioactive stent described in Fischell '166 and '617 describe coating or otherwise encapsulating a cold version of the target isotope in the stent material, and then placing the stent in a reactor to convert the stable isotope to a radioactive one. This approach, while offering some improvement over the prior method, is limited in the total activity attainable. For example, consider the activation of P-32 by neutron bombardment. Only about 1 in every 100,000 P-31 ions is converted to P-32 in the reactor chamber over a 10-day period. While this conversion rate can be increased, there is a physical limitation to this process dictated by the reactor flux, the cross section of the target atom, and the half-life of the isotope. Moreover, this method does not completely eliminate the activation of non-desired isotopes created from the stent material.
A second limitation relates to the geometry of the prior art radioactive stents. In general, balloon expandable stents comprise a plurality of struts which are spaced apart from each other when the stent is in the expanded state. A radioactive coating or ion implantation into such stents produces a radiation grid pattern which inherently delivers a nonuniform dose of radiation to the vessel wall. Many self expanding stent configurations also produce a nonuniform delivery profile.
Thus, there remains a need for a radioactive vascular liner such as a stent which is capable of delivering a substantially unifonn dose of radiation throughout its delivery zone.
SUMMARY OF THE INVENTION
There is provided in accordance with one aspect of the present invention, a tubular vascular liner for delivering a dose of radiation to the wall of a vessel. The liner comprises a flexible sheet, rolled into a tube having a first diameter for positioning at a site in a vessel. The sheet is unrollable to second, larger diameter for positioning against the wall of the vessel. A radioactive isotope is attached to the sheet, such that the radioisotope is positioned adjacent the vessel wall when the sheet is implanted and enlarged to the second diameter.
Preferably, the sheet is self expandable from the first diameter to the second diameter. In one embodiment, an outer protective coating is provided to minimize the escape of radioisotope from the sheet.
In accordance with another aspect of the present invention, there is provided a radioactive tubular prosthesis. The prosthesis comprises a flexible sheet having a first edge and a second edge. The sheet is rollable into a tube such that the first edge is disposed on the inside of the tube and the second edge is disposed on the outside of the tube. A first transition zone is provided near the first edge, and a second transition zone is provided near the second edge. The first t
Tam Lisa A.
Trauthen Brett A.
Knobbe Martens Olson & Bear LLP
Milano Michael J.
Radiance Medical Systems, Inc.
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