Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
1998-10-28
2002-06-04
Lacyk, John P. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
C604S096010
Reexamination Certificate
active
06398708
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to intralumenal or intravascular catheters used to delivery radiation inside a living body. More specifically, the present invention relates to radioactive perfusion balloon catheters for therapeutic purposes.
BACKGROUND OF THE INVENTION
Intravascular diseases are commonly treated by relatively non-invasive techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). These therapeutic techniques are well known in the art and typically involve use of a guide wire and a balloon catheter, possibly in combination with other intravascular devices. A typical balloon catheter has an elongate shaft with a balloon attached to its distal end and a manifold attached to the proximal end. In use, the balloon catheter is advanced over the guide wire such that the balloon is positioned adjacent a restriction in a diseased vessel. The balloon is then inflated and the restriction in the vessel is opened.
Vascular restrictions that have been dilated do not always remain open. In approximately 30% of the cases, a restriction reappears over a period of months. The mechanism of this restenosis is not understood. The mechanism is believed to be different from the mechanism that caused the original stenosis. It is believed that rapid proliferation of vascular smooth muscle cells surrounding the dilated region may be involved. Restenosis may be in part a healing response to the dilation, including the formation of scar tissue.
Drug infusion near the stenosis has been proposed as a means to inhibit restenosis. U.S. Pat. No. 5,558,642 to Schweich, Jr. et al. describes drug delivery devices and methods for delivering pharmacological agents to vessel walls in conjunction with angioplasty.
Intravascular radiation, including thermal, light and radioactive radiation, has been proposed as a means to prevent or reduce the effects of restenosis. For example, U.S. Pat. No. 4,799,479 to Spears suggests that heating a dilated restriction may prevent gradual restenosis at the dilation site. In addition, U.S. Pat. No. 5,417,653 to Sahota et al. suggests that delivering relatively low energy light, following dilatation of a stenosis, may inhibit restenosis. Furthermore, U.S. Pat. No. 5,199,939 to Dake et al. suggests that intravascular delivery of radioactive radiation may be used to prevent restenosis. While most clinical studies suggest that thermal radiation and light radiation are not significantly effective in reducing restenosis, some clinical studies have indicated that intravascular delivery of radioactive radiation is a promising solution to the restenosis enigma.
Since radiation prevents restenosis but will not dilate a stenosis, radiation is preferably administered during or after dilatation. European Pat. No. 0 688 580 to Verin discloses a device and method for simultaneously dilating a stenosis and delivering radioactive radiation. In particular, Verin discloses a balloon dilatation catheter having an open-ended lumen extending therethrough for the delivery of a radioactive guide wire.
One problem associated with the open-ended lumen design is that bodily fluids (e.g., blood) may come into contact with the radioactive guide wire. This may result in contamination of the guide wire bodily fluid and require the resterilization or disposal of the radioactive guide wire. To address these issues, U.S. Pat. No. 5,503,613 to Weinberger et al. proposes the use of a separate closed-ended lumen in a balloon catheter. The closed-ended lumen may be used to deliver a radioactive guide wire without the risk of contaminating the blood and without the need to resterilize or dispose of the radiation source.
The closed-ended lumen design also has draw backs. For example, the addition of a separate delivery lumen tends to increase the overall profile of the catheter. An increase in profile is not desirable because it may reduce flow rate of fluid injections into the guide catheter and it may interfere with navigation in small vessels.
Another problem with both the open-ended and closed-ended devices is that radiation must travel through the fluid filled balloon in order to reach the treatment site. While this is not a problem for gamma radiation, it poses a significant problem for beta radiation which does not penetrate as well as gamma radiation. Beta radiation is considered a good candidate for radiation treatment because it is easy to shield and control exposure. In larger vessels (e.g., 0.5 cm or larger), a fluid filled balloon absorbs a significant amount of beta radiation and severely limits exposure to the treatment site.
Other intravascular treatments, including delivery of radioactive radiation have been proposed as a means to prevent or reduce the effects of restenosis. Dake et al. suggest delivering radiation within the distal portion of a tubular catheter. Fischell, in the publication EPO 0 593 136 A1, suggests placing a thin wire having a radioactive tip near the site of vessel wall trauma for a limited time to prevent restenosis. Problems exist in attempting to provide uniform radiation exposure using a point or line source. Specifically, as the radiation varies inversely with the square of distance for a point source and inversely with distance for a line source laying off center near one vessel wall may significantly overexpose the nearby wall while underexposing the further away wall. This is especially critical for beta radiation which is absorbed by tissue and blood at a relatively short distance from the source.
Bradshaw, in PCT publication WO 94/25106, proposes using an inflatable balloon to center the radiation source wire tip. In PCT publication WO 96/14898, Bradshaw et al. propose use of centering balloons which allow blood perfusion around the balloon during treatment. U.S. Pat. No. 5,540,659 to Tierstein suggests use of a helical centering balloon, attached to a catheter at points about the radiation source to allow perfusion through the balloon, between the balloon and radiation ribbon source.
Use of continuous centering balloons, having a beta radiation source within, significantly attenuate the beta radiation when filled with inflation fluid and they may also allow the radiation source to “warp” when placed across curved vessel regions, allowing the balloon to bend but having the central radiation source lying in a straight line between the two ends. Segmented centering balloons may improve the warping problem but may have significant beta attenuation due to blood standing or flowing between the beta source and vessel walls. What remains to be provided is an improved apparatus and method for delivering uniform radiation to vessel interiors to inhibit restenosis. What remains to be provided is an improved perfusion catheter having radiation delivery and drug infusion capabilities.
SUMMARY OF THE INVENTION
The present invention includes devices and methods for providing radiation to the interior of human body vessels. Preferred devices include both devices having spaced apart, sparse helical windings and devices having tightly wound, closely spaced helical or spiral windings. Preferred sparsely wound devices include a helical perfusion balloon, having at least one helical strand configured into multiple windings having the windings spaced apart longitudinally. The preferred device includes a balloon assembly disposed at the distal region of a catheter shaft, where the catheter shaft includes an inflation lumen, a radiation wire lumen, and a drug infusion lumen. In the distal region, the radiation wire lumen can be disposed above the shaft, making room for a distal, single-operator-exchange guide wire lumen. The spiral, inflatable windings are laced inside shaft through-holes transverse to the shaft longitudinal axis and preferably off center. Lacing the helical strand through the shaft secures the helical balloon to the shaft. Lacing the strands also provides positions along the shaft in between windings for the placement of drug infusion apertures. Preferred devices includ
Hastings Roger N.
Urick Michael J.
Crompton Seager & Tufte LLC
Lacyk John P.
Sci-Med Life Systems, Inc.
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