JPH1080497A - Method combining angioplasty procedure and intravascular irradiation treatment and device therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make it possible to execute a radiation treatment of the specific region of the cardiovascular system damaged to prevent a recurrence stricture by providing an internal chamber with an IRT procedure balloon and means for exposing a target region with a radioactive material by filling fluid contg. radioactive material in the internal chamber of this procedure balloon. SOLUTION: A catheter of a suitable size is selected and is so positioned in the patient's blood vessel that an angioplasty balloon 32 exists within the target region inclusive of the constricted region of the blood vessel. The stricture is removed by expanding an angioplasty balloon 32. A shielded injector 16 is connected to a vessel 20 at the base of a catheter shaft 10 after the end of the procedure and air is discharged from the IRT procedure balloon 42 and the flow passage 12 for expansion. The balloon 42 is filled with the liquid contg. suspended isotope until the outside wall of the IRT procedure balloon 42 engages gently with the inside wall of the blood vessel. This balloon is maintained at the expanded state for the prescribed time when the radiations of the dose effective for the blood vessel wall are emitted. The fluid is then removed and the catheter is drawn from the inside of the body.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to in vivo radiation therapy for specific tissues, and more particularly, to restenosis.
The present invention relates to a method for radiotherapy of a specific area of the injured cardiovascular system in order to prevent (restenosis), particularly to a radiotherapy for preventing restenosis of an artery damaged by PTA (percutaneous transluminal angioplasty). It is.

[0002]

2. Description of the Related Art PTA treatment of coronary arteries, ie, PTC
A (percutaneous transluminal coronary angioplast
y), also known as balloon angioplasty, is the primary treatment for coronary stenosis, which in 1990 was approximately 300,0
It is estimated that 00 cases were treated and 400,000 treatments were given in 1992. The United States accounts for half of the total market for this treatment. The reputation of PTCA treatment is due to its high success rate and very low tissue damage compared to coronary artery bypass surgery. But PT
Patients receiving CA treatment are more likely to have restenosis,
About 35% of all patients undergo repeated PCTA treatment,
Bypass surgery must be performed, adding cost and increasing patient risk. Recently, attempts have been made to prevent restenosis using drugs, equipment and other experimental techniques with limited success.

[0003] Restenosis is a procedure in which angioplasty (a
This is caused by damage to the artery wall when performing ngioplasty). In some patients, a repair response is initiated by angiogenesis in the injured area after this injury. This repair response is characterized by hyperplastic growth of vascular smooth muscle cells. Smooth muscle cell hyperplasia narrows the vascular cavity opened by angioplasty and may require PTCA again or other treatment to reduce restenosis.

[0004] Intervascular radiot
Herapy, IRT) has been shown in preliminary studies to be effective in preventing and prolonging restenosis after angioplasty. In addition, it is said that IRT can also be used to prevent stenosis or other vascular wall injuries following cardiovascular graft treatment. It is important that proper control of the radiation dose be suppressed and prevented from hyperplasia without excessively damaging healthy tissue. Excessive irradiation of parts of blood vessels causes arterial necrosis, inflammation, and bleeding.
Insufficient radiation dose will not prevent smooth muscle cell hyperplasia, or will lead to hyperplasia leading to restenosis.

[0005] Fishell, US Pat.
No. 059,166 discloses an IRT method with a radioactive stent that is permanently inserted into a blood vessel after an incision in the vessel lumen. It is difficult to maintain precise control of the radiation dose delivered to a patient by a permanently inserted stent, since the overall dose is determined solely by the activity of the stent during insertion. Further, the tissue in contact with each atrioventricular chamber of the stent receives a higher dose than the tissue between each atrioventricular chamber, so that the dose to the blood vessels is non-uniform. The non-uniform distribution of the irradiation dose is particularly dangerous if the stent contains a low penetration source, such as a β-ray source.

[0006]

U.S. Pat. No. 5,302,168 to Hess teaches the use of a radiation source mounted on a flexible carrier having a remote control window.
Johann Wolfgang Goelje University Medical Center, Frankfurt, Germany Bot Hells (H.Bottch
er et al. Johann Wolfgang Goerhe University Medica
l Center, Frankfurt, Germany) reported in November 1992 that a similar luminal radiation source was used to treat human superficial femoral arteries. In order to provide an effective irradiation dose by these methods, it is generally necessary to use a radiation source that is more active than a radiation stent. Accordingly, local overexposure of the tissue by the radiation source must be prevented by means of ensuring that the source is held well centered in the vessel lumen. The use of highly active radiation sources requires the use of expensive radiation shields and other equipment to safely handle the source.

[0007] US Patent Application No. 08 / 352,318, incorporated herein by reference, discloses an IRT method and apparatus for easily controlling the radiation dose and uniformly irradiating the vessel wall. However, this method and apparatus requires special means of placing the radiation source in the center of the vessel lumen, expensive radiation shields to protect medical personnel, or expensive remote afterloaders for handling highly active radiation sources Do not need. The patent application further discloses a method and apparatus for removing a stenotic region of a blood vessel and performing an IRT procedure with a single device.

[0008] Means are provided to extend the range of the IRT procedure beyond the angioplasty procedure, providing further advantages when irradiating the angioplasty procedure itself and the proximal and distal regions of the angioplasty procedure. is there. By performing the IRT treatment over a wider range than the angioplasty treatment range, hyperplasia of smooth muscle cells can be properly prevented.

[0009]

SUMMARY OF THE INVENTION The present invention uses a single treatment catheter for all or at least the final stages of an angioplasty procedure and for all of the IRT procedures. The treatment catheter is comprised of an elongated flexible member having an angioplasty balloon surrounded by an IRT treatment balloon. The catheter is inserted into the patient's cardiovascular system until the balloon reaches the target area, including the stenotic area of the blood vessel. The stenosis is first removed using an inner angioplasty balloon and then I
The target tissue is irradiated by filling the RT treatment balloon with a radioactive fluid and gently engaging the outer wall of the balloon with the inner wall of the blood vessel.

[0010]

In one embodiment of the present invention, the radioactive fluid comprises a beta emitter, such as ³² P, or a photon emitter, such as ¹²⁵ I, suspended in a fluid carrier. Radiation emitted from such sources is quickly absorbed by the surrounding tissue and penetrates less across the vessel wall being treated. Thus, incidental illumination of the heart and other organs in close proximity to the treatment site is virtually eliminated. Since the radioactive material is substantially uniformly suspended in the radioactive fluid, the radiation emitted at the balloon surface in contact with the target area of the blood vessel is inherently uniform. Therefore, the uniform irradiation to the blood vessel wall is performed as an inherent property.

According to one embodiment of the present invention, the outer IRT
The treatment balloon is made longer than the inner angioplasty balloon. Thus, the IRT treatment balloon, when filled with radioactive fluid, illuminates portions of the blood vessel that extend on both sides beyond the area treated with the angioplasty balloon. This extended IRT treatment area has a safety margin, so that even if the catheter shifts slightly during the procedure, all injured areas of the vessel are treated to prevent smooth muscle cell hyperplasia.

[0012] The catheter of the present invention may also be provided with perfusion ports on the base side and the distal side of the balloon so that blood flows around the balloon when the balloon is inflated.

In another embodiment of the invention, a third balloon is provided to completely surround the IRT treatment balloon. The containment balloon acts as a containment tube when the IRT treatment balloon ruptures when filled with radioactive fluid. Prior to filling the treatment balloon with the radioactive fluid in use, the containment balloon is preferably filled with a non-toxic, radiopaque fluid to ensure that the containment balloon is intact. By filling the containment balloon with a radiopaque fluid, the positioning of the catheter at the target area of the vessel can be accurate.

After the angioplasty procedure has been performed, the angioplasty balloon may be deflated or slightly inflated. If the angioplasty balloon is slightly inflated, the space inside the IRT treatment balloon becomes narrower.
The amount of radioactive fluid required to fill the treatment balloon is reduced. Due to the self-damping effect of the radioactive fluid itself, most radioactivity occurs on the surface of the treatment balloon. Thus, even if the center of the balloon is filled with an inert material, surface radiation is hardly reduced. Thus, using a fairly low emissivity fluid will result in a radiation level equivalent to that when the IRT treatment balloon is completely filled with radioactive fluid.

[0015] In another embodiment of the present invention, a proximal and distal sealing balloon is also provided, which stops the radioactive fluid at the target area if the entire containment system fails to operate.

The above and other objects and aspects of the present invention,
Features and attendant advantages will become apparent from a consideration of the following detailed description of the preferred embodiments, taken in conjunction with the accompanying drawings.

[0017]

1A and 1B show a suspension isotope IRT catheter of the present invention. The IRT catheter has an angioplasty inflation channel 11, an IRT inflation channel.
12, comprising a shaft 10 having a conventionally formed tip, the shaft 10 having a guide wire /
It may have a hole 14 for injection / perfusion. A radiation shielded injector 16 is connected to the base of the shaft 10 and communicates fluid to the IRT expansion channel 12. Injector 16 can be a manual or automatic injector containing radioactive liquid 30, or a pump connected to a tank of radioactive liquid 30. The shielded injector 16 is permanently fixed to the shaft 10 or preferably the injector 16 to prevent possible radioactive leakage and the associated radioactive contamination of the operating room and / or medical personnel.
Is attached to a fail-safe non-separable connector 18 which, once attached to the corresponding container 20 of the shaft 10, does not come off. This non-separable connector 18 prevents radioactive fluid 30 from being discharged from injector 16 until the connector is connected to the container of shaft 10.
Connectors and other non-separable fluid fittings with ring-shaped fasteners are known in the art and perforate valves and other common methods of preventing fluid flow until mounted on a fluid fitting. Etc. The base of the shaft 10 has an angioplasty luer joint 15 communicating with the angioplasty inflation flow path 11 so that the fluid flows therethrough, and a guide wire hole 14.
And a guidewire bore luer fitting 17 in fluid communication therethrough, through which the drug is infused directly into the patient's bloodstream.

FIG. 1C is an enlarged view of the distal end of the catheter of this embodiment. The angioplasty balloon 32 may be made of a conventional elastic or, preferably, inelastic balloon material, preferably polyethylene terephthalate (PET), polyvinyl chloride (P).
VC) or other medical grade material suitable for constructing strong, inflexible balloons. Angioplasty balloon 32 is connected to an inflation channel for angioplasty via port 34.
It communicates with 11 to allow fluid to flow. Immediately inside the base and distal end of balloon 32 is a marker 36,
36 is constructed of a silver band or other suitable X-ray impermeable material. The markers 36 help to properly position the angioplasty balloon 32 within the target area of the vessel under fluoroscopy.

An IRT treatment balloon 42 is positioned at the end of the shaft 10 and surrounds the angioplasty balloon 32. The IRT treatment balloon is an inelastic or preferably elastic balloon,
It is preferably constructed of a medical grade material suitable for constructing latex or other puncture resistant elastic balloons. The IRT treatment balloon 42 is sealed at the base and distal end to the catheter shaft 10 and communicates with the inflation channel 12 through an inflation port 44 for fluid flow.

A perfusion port 48 is located just outside the end of the IRT treatment balloon 42 and communicates with the guidewire hole 14 for fluid flow. Perfusion ports are known in the art as a means of flowing blood to avoid balloons that expand or block blood vessels.

In operation, an appropriately sized catheter of the present invention is selected and positioned by conventional means within the patient's blood vessel such that the balloon is within the target area, including the stenotic area of the blood vessel. In a conventional manner, the angioplasty balloon is inflated to remove the stenosis. After the end of the angioplasty procedure,
A shielded injector 16 is connected to the container at the base of the catheter shaft, and air is exhausted from the IRT treatment balloon and the inflation channel. In the case of a shielded syringe, simply pull the plunger. The balloon was then filled with the liquid containing the suspended isotope until the outer wall of the balloon gently engaged the inner wall of the vessel. The balloon is maintained in an inflated state for a predetermined period of time calculated to deliver an effective dose of radiation to the vessel wall. The fluid is then withdrawn from the balloon and the cartel is withdrawn from the patient's body.

A pressure feedback device 22 is connected to the base of the inflation channel 12 to prevent excessive pressure on the treatment balloon and rupture of the balloon. The pressure feedback device 22 can be a pressure gauge or preferably a solid-state pressure transducer, which, upon detecting excessive pressure, activates the alarm 24 and / or the wastegate 26, The liquid is discharged from the expansion channel 12 into the radiation-shielded container. A solid-state pressure transducer may be located at the end of the inflation channel, in which case the pressure is measured directly within the balloon.

To enhance safety, before filling the IRT treatment balloon with radioactive fluid, fill it with a commonly used non-toxic, radiopaque contrast agent to ensure that the IRT treatment balloon is intact. Is also good. Once confirmed to be intact, the contrast is drained and a shielded syringe 16 is connected to the container at the end of the catheter shaft. The radioactive fluid is diluted with a small amount of contrast agent remaining on the IRT treatment balloon, but the dilution is measurable and can be compensated.

FIGS. 2A-2C show the outer containment balloon.
FIG. 15 shows another example of an embodiment of the present invention further comprising 52; The containment balloon 52 is an inelastic or preferably elastic balloon, preferably of latex or other medical grade material suitable for constructing a puncture resistant elastic balloon. A containment balloon 52 is sealed to the shaft 10 at the base and the distal end and completely surrounds the treatment balloon 32. The containment balloon 52 communicates with the containment balloon inflation channel 54 via a containment balloon inflation port 56 so that fluid can flow therethrough.
Is the luer fitting of the containment balloon at the base of the shaft 10
Communicates with 58 for fluid flow.

In operation, after positioning of the IRT cartel and before the IRT treatment balloon 42 is filled with radioactive fluid, the containment balloon 52 receives the normally used non-toxic and non-toxic radiation injected from the containment balloon luer fitting 58. Filled with non-transmitting contrast agent. The integrity of the containment balloon is confirmed by fluoroscopy, pressure, or other suitable means, and if it is, the radiopaque liquid is drained and radioactive fluid is applied to the treatment balloon 42. Perform the injection operation. If the containment balloon is flawed (sharp edge of guide catheter, guide wire, stent, etc.), select and reposition a new catheter. After the containment balloon has been positioned and proven intact, prior to injecting the radioactive fluid, reliable safety measures are taken to prevent accidental infusion of the radioactive fluid into the patient's bloodstream. If a containment balloon is used (or if the closure balloon described with reference to FIGS. 3 (a)-(c) is used), the emergency evacuation system can be activated using the pressure feedback device 22. When the pressure feedback device detects a sudden drop in pressure (indicating a rupture of the treatment balloon), the pressure feedback device immediately removes all radioactive fluid from the patient.
For example, the valve is opened to start discharging to the radiation-shielded vacuum accumulator 28.

In order to safely and effectively inject a radioactive fluid into a patient and irradiate the blood vessels to prevent restenosis, important considerations regarding the design of the device must be adjusted.
¹²⁵ I and ³² P in Both low permeability radiator, since it is suitable for use in the present invention, ^{125 32} half-life of P with respect to the half-life 60 days I is 14.3 days and short ³² P is preferred. The irradiation amount of the predetermined calculation, because the total exposure amount of the shorter half-life body decreases if the occurred disaster radioactive fluid leaks into the blood stream of a patient, who short ³² P half-life Is more secure. ³² P is also a relatively pure β-emitter. ³² P has been used directly in the bloodstream to treat patients with chronic leukemia. Thus, there is a wealth of medical knowledge regarding the effects of ³² P in the bloodstream.

The treatment of leukemia depends on the weight of the patient,
A source of suspended radiation of about 6-15 millicuries of ³² P is used. Therefore, for maximum safety, it is preferred to use a source of no more than 6 millicuries for the suspension isotope IRT catheter. Previous experiments have shown that a dose of about 1000-3500 rads applied to the vessel wall from a gamma radiation source is effective in preventing smooth muscle cell hyperplasia, which causes restenosis. It is believed that doses of up to 5000 rads are acceptable for low-transmittance sources such as beta emitters. In order to irradiate the same amount of blood to the surface of a blood vessel with a 6 P curry ³² P source, the balloon must be fixed for approximately one minute or more, and a perfusion port is required.

For example, it has been estimated that balloons absorb about 15% of the radiation emitted from the radioactive fluid. Therefore, to irradiate the blood vessel wall with 2000 rads, 2350 rads must be irradiated inside the balloon wall. A typical treatment balloon has an inner diameter of 3 mm, a length of about 30 mm, and a content of about 3 mm.
0.2 cm ³ cylindrical balloon. Therefore, to limit the total source to 6 millicuries or less, 30 millicuries /
A 0.2 cm ³ liquid with a source of a concentration of ³ cm ³ must be used. However, at a concentration of 30 millicuries / cm ³ , it takes about 6 minutes to irradiate 2350 rads inside the wall of a treatment balloon having an inner diameter of 3 mm, and it takes about 6 minutes to irradiate 2000 rads inside the blood vessel wall. Need for minutes.

The larger the balloon, the lower the radiation source concentration in the liquid which must maintain a safety limit of 6 millicuries. However, at lower concentrations, the dose is reduced and the balloon must be inflated longer to irradiate the vessel wall with an effective dose.

To reduce the amount of radioactive fluid that must be used, a portion or a substantial portion of the angioplasty balloon 32 can be filled during the IRT procedure. Fluids near the center of a mass of radioactive fluid contribute little to the radiation emitted from the mass surface,
By slightly filling the angioplasty balloon 32 at the center of the IRT treatment balloon, less radioactive liquid can be used with little effect on the radiation delivered to the vessel wall. To avoid exceeding the 6 millicurie limit without using an angioplasty balloon acting as an inert filler, treatment balloons of the same size require lower concentrations and more radioactive fluid. The irradiation dose is low and the treatment time is long.

FIGS. 3 (a)-(c) show yet another embodiment of the present invention having a closure balloon 62. FIG. Blockade balloon
62 is an inelastic or preferably elastic balloon, preferably of latex or other medical grade material suitable for constructing a puncture resistant elastic balloon. The sealing balloon 62 is sealed to the shaft 10 at the base and the distal end of the treatment balloon 42 between the perfusion ports 48, and is connected to the inflation port.
Fluid flows through a common sealing balloon inflation channel 64 through 66, and the sealing balloon inflation channel 64 communicates with a luer-type joint 68 of the sealing balloon at the base of the shaft 10 for fluid flow. ing.

In operation, after the angioplasty procedure is completed, the balloon is inflated in the blood vessel until the blood flowing through the sealing balloon 62 is substantially stopped (the flow of blood in the blood vessel itself continues through the perfusion port). . The treatment balloon 42 is then inflated with a radioactive fluid for treating the vessel wall. If the treatment balloon 42 ruptures and the containment balloon 52 fails at the same time, the radioactive fluid remains in the vessel between the closure balloons 62. The fluid may be drained through any inflation channel that communicates with the interior of the vessel between the occlusion balloon 62 and the rupture for fluid rupture or, preferably, through FIGS. 2 (a)-(c).
Can be automatically discharged using the emergency discharge system described with reference to FIG. Sealing balloons can be used in place of the containment balloon 52, especially for small blood vessels, which preferably have a small profile.

Thus, the present invention provides a safe and effective method and apparatus combining an angioplasty procedure and a restenosis prevention procedure, wherein the method and apparatus provide a method for treating a vessel wall in an area that has been damaged by an angioplasty procedure. This is due to the fact that radiation of an originally uniform dose that can be easily controlled is applied so that the therapeutic effect is not lost due to improper positioning of the radiation source.

Although the preferred embodiment of the present invention has been described above, those skilled in the art can understand from the above disclosure that variations and modifications of the present embodiment do not depart from the scope of the present invention. Like. Accordingly, the invention is limited only by the claims and the applicable legal provisions and doctrines.

[Brief description of the drawings]

1 (a) to 1 (c) show a plan view and a cross-sectional view of a device of the present invention.

2 (a) to 2 (c) show a plan view and a cross-sectional view of a modified example of the device of the present invention provided with a containment balloon.

3 (a) to 3 (c) show a plan view and a cross-sectional view of a modified example of the device of the present invention in which a sealing balloon is provided at the end and the tip.

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[Procedure amendment]

[Submission date] January 8, 1997

[Procedure amendment 1]

[Document name to be amended] Drawing

[Correction target item name] Fig. 4

[Correction method] Deleted ───────────────────────────────────────────── ────────

[Procedure amendment]

[Submission date] January 8, 1997

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Name of invention

[Correction method] Change

[Correction contents]

Patent application title: Method and apparatus combining angioplasty and endovascular radiation therapy ──────────────────────

[Procedure amendment]

[Submission date] April 21, 1997

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Name of invention

[Correction method] Change

[Correction contents]

Title: Method and apparatus for combining angioplasty and endovascular radiation therapy

Continuation of front page (72) Inventor Richard Tea. Thornton United States 77573 Texas League City Warwick Drive 2668 (72) Inventor Wayne W. Wright. Snyder United States 77062 Texas Houston Beachcomber 914

Claims (20)

[Claims] 1. A device for local endovascular radiation therapy of a blood vessel, such as a coronary artery, comprising: a catheter having an elongate member having a base and a distal end, the elongate member having a distal end in a target region within the blood vessel. Having a flexibility and dimensions that can be introduced into the patient's body through the cardiovascular lumen until the elongate member has first and second longitudinally extending flow paths;
This channel is a channel for inflation of the angioplasty balloon and
A catheter serving as a flow path for inflation of the treatment balloon;
An angioplasty balloon having an inner chamber, said angioplasty balloon being attached to a distal end of said elongate member such that the inner chamber is in fluid communication with a flow path for inflation of the angioplasty balloon; An IRT treatment balloon comprising an inflatable balloon having an IRT treatment balloon attached to the distal end of the elongate member such that an interior chamber surrounds the angioplasty balloon; Means for injecting into a flow channel for use to fill the interior chamber of the treatment balloon and expose the target area with radioactive material. 2. The device of claim 1, wherein the IRT treatment balloon comprises means for perfusing blood flowing upon inflation of the balloon. 3. The apparatus of claim 1, further comprising means for detecting pressure within the IRT treatment balloon. 4. The device according to claim 1, further comprising a fluid containing a radioactive substance that can be introduced into the balloon by the introduction means. 5. The apparatus according to claim 4, wherein the fluid containing a radioactive substance comprises a fluid having a substance selected from the group consisting of iodine and phosphorus. 6. The apparatus of claim 1, wherein the introduction means comprises a radiation shielded syringe. 7. The device according to claim 6, wherein the radiation shielded syringe is permanently fixed to the catheter. 8. The device of claim 7, wherein the radiation shielded syringe has a fail-safe non-separable fluid coupling and the catheter has a corresponding fail-safe non-separable container. 9. The apparatus according to claim 1, wherein the introduction means comprises a pump. 10. The device according to claim 9, wherein the pump is permanently fixed to the catheter. 11. The device of claim 10, wherein the pump has a failsafe non-separable fluid coupling and the catheter has a corresponding failsafe nonseparable container. 12. The apparatus according to claim 1, further comprising means for introducing a contrast agent into the flow path for inflating the IRT treatment balloon to fill the inner chamber of the IRT treatment balloon and confirming that the IRT treatment balloon is intact. 13. The device of claim 1, wherein the containment balloon comprises an inflatable balloon having an interior chamber, the interior chamber comprising a containment balloon surrounding the IRT treatment balloon. 14. The elongate member has a longitudinally extending flow path, the flow path being a flow path for inflation of the containment balloon, wherein the inner chamber of the containment balloon has a flow path for inflation of the containment balloon. 13. The device of claim 12, wherein the device is in fluid communication. 15. Introducing a contrast agent into a flow path for inflation of the containment balloon to fill the interior chamber of the containment balloon,
14. Apparatus according to claim 13, comprising means for proving that the containment balloon is intact. 16. When the containment balloon is inflated,
14. The device according to claim 13, comprising means for perfusing blood around the containment balloon. 17. A method according to claim 17, further comprising first and second sealing balloons each having an internal chamber, wherein the first sealing balloon is attached to a distal end of the treatment balloon at a distal end of the elongate member, and a second sealing balloon is disposed on the distal end of the elongate member. At the distal end, attached to the base of the treatment balloon, the elongate member has a flow path for sealing balloon inflation, the flow path for sealing balloon inflation has a longitudinal flow path for the elongate member, and first and second The device of claim 1, wherein the interior chamber of the sealing balloon is in fluid communication with a flow path for inflation of the sealing balloon. 18. A method of removing stenosis at a specific site in a blood vessel of a patient and preventing restenosis, comprising: a catheter having an elongated member having a distal end, the distal end of the catheter having an angioplasty balloon. And an IRT treatment balloon attached thereto, wherein the IRT treatment balloon comprises an inflatable balloon substantially surrounding the angioplasty balloon, the catheter having flexibility and dimensions that can be introduced to said particular site of the blood vessel. And inserting a catheter along the patient's cardiovascular lumen until the IRT-treated balloon reaches the specific site in the blood vessel, inflating the angioplasty balloon to remove the stenotic region of the vessel, The IRT balloon inflated with the liquid containing the substance, the IRT balloon inflated with the liquid is held for a predetermined time, and the liquid is drained from the treatment balloon to remove the treatment balloon. Pursed down, wherein the withdrawal of the catheter from the patient. 19. The method of claim 18, wherein before inflating the IRT treatment balloon with a liquid containing a radioactive substance, the IRT treatment balloon is inflated with a radiopaque contrast agent to confirm that the containment balloon is intact. The described method. 20. The catheter has a containment balloon positioned near the treatment balloon, and before inflating the IRT treatment balloon, inflates the containment balloon with a radiopaque contrast agent to confirm that the containment balloon is intact. 19. The method of claim 18, wherein the method comprises: