Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
1999-08-06
2001-05-22
Lacyk, John P. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
Reexamination Certificate
active
06234952
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of treating an occlusion or a constriction, such as a stenosis which would occur in various blood vessels and other bodily conduits as well as to the field of angioplasty. Additionally, the present invention is directed to the field of treating cancer which would occur in various body conduits or ducts, as well as to the field of brachytherapy.
2. Description of the Prior Art
Various techniques have been developed to treat many different conduits in the body when these conduits have become reduced in size due to the existence of a stenosis or have been completely occluded. These techniques include introducing a deflated balloon catheter to the site of an occlusion or constriction, such as a stenosis, inflating the balloon one or more times to eliminate the size of the stenosis, deflating the balloon and then removing the balloon catheter from the treatment site.
With respect to the vascular pathways, angioplasty is used to open an artery or blood vessel in the region where the stenosis or the occlusion has occurred. A typical angioplasty procedure consists of making a small incision through the body and into a blood vessel and then maneuvering a guide wire through the vascular system to a point beyond the stenosis or occlusion. A hollow catheter with a deflatable balloon near its distal end is threaded over the guide wire and advanced to the point of stenosis or occlusion. The balloon is then inflated and deflated several times to widen the constricted area, and is then withdrawn from the body.
Unfortunately, although the angioplasty procedure does markedly reduce the area of stenosis or occlusion, many patients exhibit a reoccurrence of the stenosis within a few months of the original procedure.
Although the original stenosis occurs by means of the build up of plaque over a relatively long period of time, experimentation has lead many to believe that the reoccurrence of the stenosis after the original angioplasty procedure is unrelated to the cause of the original stenosis. It is believed that the inflation of the balloon catheter used in the angio-plasty procedure or the placement of a stent in the area of the stenosis causes irritation to the blood vessel. This irritation produces a mechanism of action called hyperplasia, inducing the inner layer of the blood vessel cells to rapidly reproduce, thereby causing restenosis. It has been proposed that if the blood vessel is irradiated at the point of the stenosis with a radioactive dose, the mechanism that causes hyperplasia would be destroyed without harming the blood vessel itself.
During this procedure, it is important to precisely control the amount of radiation which is directed to the blood vessel wall, since too much radiation could actually induce hyperplasia as well as destroying a portion of the blood vessel, making it possible for an aneurism or rupture to occur. U.S. Pat. No. 5,213,561 issued to Weinstein et al and U.S. Pat. No. 5,199,939 issued to Dake et al, as well as PCT Application PCT/US92/07447 to Shefer et al, describe various methods and apparatus for introducing radiation to the site of a stenosis to endeavor to prevent restenosis.
The Weinstein et al patent describes a method and apparatus for preventing restenosis after angioplasty. A balloon catheter transported by a conventional guide wire is delivered to the location of the stenosis. Particles or crystals of radioactive material are embedded or mounted on a tube provided inside the balloon catheter. A retractable radiation shielding sleeve is slidable along the tube to cover the source of radioactive material. Upon completion of the angioplasty, the shielding sleeve is retracted and the area of the stenosis is irradiated. Although this apparatus does introduce radiation to the point of the stenosis, the retractable shielding surrounding the source of radioactive material makes this catheter bulky and unwieldy to use. In this regard, it is very doubtful that a catheter system this bulky would fit into the smaller branches or vessels of the heart. It is also doubtful that a catheter this bulky and stiff could be maneuvered through the tighter bends and turns in many of the vessels.
An additional embodiment of the Weinstein et al patent illustrates a stent which is made of or coated with a radioactive material such as iridium 192. Since the radioactive material is provided on the outer surface of the stent, it is very difficult to precisely administer the proper dosage of radiation to prevent hyperplasia without administering a level of radiation which would actually induce hyperplasia or other deleterious effects to the blood vessel.
The PCT application illustrates a method and apparatus for restenosis treatment by applying a radioactive dose to the stenosed region after reduction of the region by angioplasty or other means. As shown in
FIG. 4
, an angioplasty balloon is expanded in the vicinity of a lesion site and radioactive elements provided on the exterior surface of the balloon are forced into contact with the region. Therefore, similar to the Weinstein et al patent, the presence of the radioactive material on the exterior of the catheter would make it very difficult to apply the precise amount of radiation to the region of interest. Additionally, both the PCT application as well as the patent to Weinstein describe balloon catheters which do not allow the blood within the vessel to flow during inflation of the balloon.
Although there have been some attempts to construct a dilatation balloon allowing for some perfusion of bodily fluids during the inflation phase of the dilatation, the perfusion is greatly diminished by the overall size of the inflated balloon. Dilatation balloons must be able to hold a great amount of pressure (up to 16 atmospheres) and must also be able to inflate to large overall diameters to open the stenosis areas inside the bodily conduits or narrow tortuous passageways. Both of these requirements lead to large, bulky dilatation balloons that encompass most, if not all, of the area inside the stenosed vessel leading to large blockages of bodily fluids and thus allowing for little, if any perfusion.
These types of balloons are described in U.S. Pat. Nos. 5,295,959, issued to Gurbel et al and U.S. Pat. No. 5,308,356, issued to Blackshear, Jr. et al. Both of these patents describe a passive perfusion dilatation catheter having a series of non-longitudinal lobes. As particularly illustrated in
FIG. 1
of the Blackshear, Jr. et al patent, virtually the entire interior of the bodily conduit is blocked when the dilatation balloon is inflated, thereby preventing the flow of bodily fluids around the treatment site. Additionally, due to the particular structure of the balloons utilized, neither the Gurbel et al nor the Blackshear, Jr. et al balloon can be used to precisely center the catheter within the bodily conduit at the site of treatment.
Attempts to utilize these types of dilatation balloons as a centering balloon or treating the patient with radioactive materials would greatly compromise the patient for the many minutes while the treatment is being implemented due to the diminished flow of bodily fluids or, in some cases, the complete blockage of bodily fluids. Any compromises to the dilatation balloon to achieve a greater flow rate would greatly decrease the effectiveness of the balloon on the stenosed area.
Therefore, there exists a need for a balloon catheter system that will achieve the greatest amount of dilatation possible and would also allow for the centering of the treatment lumen inside the bodily conduit or passageway while allowing for the maximum flow rate of bodily fluids around the treatment site.
The patent to Dake et al shows a radioactive catheter for preventing restenosis after angioplasty. However, this patent merely indicates that an elongated flexible catheter is transported to the area of the original stenosis after a balloon catheter has been withdrawn, thereby lengthening the time to administer the entire pr
Cadugan Joseph A.
Cantor & Colburn LLP
Interventional Therapies LLC
Lacyk John P.
LandOfFree
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