JP2002502677A - Radiation delivery catheter with hemoperfusion capability - Google Patents

Abstract

SUMMARY OF THE INVENTION The present invention is directed to a radiation distribution catheter with adequate blood circulation capacity that can maintain the body lumen widened for a time sufficient to deliver the radiation source into the body lumen. Have been. Catheters utilize an inflatable region that maintains the catheter centered within the body lumen so that blood can pass through the body lumen. The inflatable region is made of discrete segmented balloon elements that are oriented to create a path for blood to flow when inflated. In addition, the inflatable area may be an inflatable area with a nodular balloon element that inflates from an elongated catheter to contact the wall of the body lumen so that blood flows through the inflated area while the radiation treatment is being performed. It is formed.

Description

DETAILED DESCRIPTION OF THE INVENTION

BACKGROUND OF THE INVENTION [0001] The present invention relates generally to intravascular catheters, and more particularly, to performing radiation therapy within a body lumen while allowing blood perfusion to and around the catheter through the body lumen. Intravascular catheter assembly.

In a percutaneous transluminal coronary angioplasty (PTCA) procedure, a guiding catheter having a preformed distal end is introduced percutaneously into a patient's cardiovascular system via the brachial or femoral arteries. Advance through the cardiovascular system until the pre-shaped distal end is placed in the aorta adjacent to the desired coronary ostium. The guiding catheter is then twisted and torqued from its proximal end to rotate its distal end so that the catheter can be guided into the coronary ostium. With the over-the-wire dilatation catheter system,
A wire and an inflation catheter having an inflatable balloon at the distal end are introduced at the proximal end of the guide catheter and advanced to the distal end of the guide catheter seated in the coronary ostium. Typically, the distal end of the guidewire is manually shaped (ie, curved) prior to manual insertion by a physician or one of the attendants to introduce the dilatation catheter into the guide catheter. Typically, a guide wire is first advanced from the distal end of the guide catheter, guided into the patient's coronary vasculature containing the stenosis to be dilated, and then advanced beyond the stenosis. Thereafter, the dilatation catheter is advanced over the guide wire until the dilatation balloon is positioned over the stenosis. After the dilatation catheter is in place, a radiopaque liquid is applied to the balloon of the catheter with a relatively high pressure (eg, typically about 4-12
Pressure) to inflate the balloon to a predetermined size (preferably the same as the internal diameter of the artery at that particular location), thereby causing the atherosclerotic plaque of the stenosis to have a radius inside the wall of the artery. Direction, thereby increasing the diameter of the occluded artery. The catheter can then be removed and the balloon deflated so that blood flow is restored into the dilated artery.

[0003] One common problem that sometimes occurs after performing a vascular injury procedure is restenosis at or near the original site of the stenosis. If restenosis has occurred, a second vascular injury procedure and, depending on the degree of restenosis, may require bypass surgery. Various devices and procedures have been developed to prevent restenosis after arterial intervention to reduce the likelihood of developing restenosis, thereby preventing the need to perform bypass surgery or subsequent vascular injury procedures. . For example, expandable cages (commonly referred to as "stents") designed for long-term implantation of a body lumen have been utilized to help prevent the occurrence of restenosis.

[0004] A more recent device and procedure for preventing restenosis following arterial intervention is to use a radiation source to reduce smooth muscle cell proliferation, which is considered a major cause of restenosis. Balloon catheters are used to provide and maintain a source of radiation in the area where arterial intervention is to take place, exposing that area to a radiation dose sufficient to inhibit cell growth. Two devices and methods are described in WO 93/04735 (Hess) and WO 95/19807 (Weinberger). Other devices and methods that utilize radiation therapy delivered by an intravascular catheter are commonly owned and assigned May 29, 1996, which is hereby incorporated by reference.
"Radiation-Emitting Flow-Through"
Co-pending US Application No. 08 /, entitled "Temporary Stent".
No. 654698, and “Radiation D, filed on Aug. 29, 1996.
Jose Delivery Caterer with Reinfocin
g Mandrel "is disclosed in co-pending U.S. application Ser. No. 08 / 705,945. Another medical device for the treatment of human vessels by radiation is disclosed in European Patent Application 0688580 A1 (Schneider).

[0005] One problem common to many balloon catheters that deliver radiation therapy to a particular part of the patient's vasculature is that they target a lower radiation dose over a longer period of time, rather than a higher radiation dose over a shorter period of time. It is sometimes preferable to treat the area. When using conventional balloon catheters to keep open areas of the artery where restenosis can occur to allow for the delivery of a radiation source, the inflated balloon blocks blood flow through the artery. Or a limitation, which can result in a serious risk of damage to tissue downstream of the occluded portion of the artery as the tissue becomes depleted of oxygenated blood. Thus, the time the balloon remains inflated in the artery will be reduced, and the time available to maintain the radiation dose in the area of the artery where restenosis may occur will be affected. Therefore, higher radiation doses must be managed over a shorter period of time due to occlusion of the blood vessels caused by the inflated balloon catheter. This may not be as advantageous as providing a lower dose over a longer period of time.

What is needed and previously not generally available in catheters for treating blood vessels with radiation sources, restenosis can occur for a time sufficient to selectively destroy cells. An intravascular catheter assembly that allows the delivery of a radiation source to an area, prevents the development of restenosis, and allows perfusion of blood beyond the occluded area during the radiation procedure. Such an intravascular catheter is relatively easy and inexpensive to manufacture, has a strong and reliable inflatable area under pressure, the amount of inflation and deformation of the inflatable area and It must be able to be formed into various shapes to give the flexibility of the pattern. The present invention satisfies these and other needs as described below.

SUMMARY OF THE INVENTION The present invention allows a human body lumen to remain open for a sufficient time to provide a source of radiation to the body lumen while permitting perfusion of blood in blood vessels. The present invention is directed to an intravascular catheter having an inflatable region located at a distal end of a catheter body.

[0008] An intravascular catheter according to the present invention includes an elongated catheter body having a proximal end and a distal end, a guide wire lumen extending at least partially into the elongated catheter body, and a proximal end of the catheter body. An inflatable region located near the distal end of the elongate catheter body that includes communication with the extending inflation lumen.

[0009] The inflation region is flexibly configured to be inflatable over a curved portion of a human body lumen, such as a coronary artery. The inflation region is also configured to center the source wire within the body lumen, even when the inflatable region is located on a curved section of the body lumen. The inflated region implements all of the above features and still allows blood to flow past it to supply oxygenated blood to tissue downstream of the catheter when the inflated region is in its expanded position. enable.

[0010] The intravascular catheter of the present invention allows for over-the-wire delivery of an elongated catheter body to a location within a body lumen where radiation dose is to be controlled for its progress. The guidewire lumen is used to advance the elongated catheter body to the target area, as well as to advance the source wire to the target area. After the catheter has brought the inflated inflatable region into the appropriate position, which is the dilation position of the artery, the guidewire can be removed from the guidewire lumen and the radiation source can be advanced to the target region. Replacement can be accomplished by first utilizing the support mandel to place a protective sheath into the guidewire lumen and advance to the appropriate location within the mandel guidewire lumen. The support mandel can then be removed and the source wire can be advanced from the source storage facility, which can also be advanced into the protective sheath, to the target area. After positioning the source wire to provide the required radiation dose, the inflatable region can be contracted to its original unexpanded state, and then the catheter and source can be removed from the patient's vasculature. it can.

In one particular embodiment of the present invention, the inflatable region is manufactured from a plurality of discrete segment balloon elements disposed along the distal end of the elongated catheter body. Each individual balloon segment has a pair of side walls facing each other resulting in a very low profile balloon segment having a relatively small contact area that contacts the wall of the artery when inflated. Each adjacent balloon segment has a diameter of about 30 mm to increase the area between the balloon segment walls to form an expansion path through which blood passes when the balloon segment is inflated. 90 degrees off. This particular configuration of individual balloon segments provides sufficient support in the artery to maintain the catheter in place and center the source wire within the body lumen, and is downstream of the inflatable region. It still provides a sufficient path for blood to flow over and over the individual balloon segments during inflation so as to prevent the lack of oxygenated blood to the tissue.

In one particular embodiment of the present invention, the inflatable region is made from a plurality of individual spherical elements that protrude from the surface of the elongated catheter body when inflated. These spherical elements, when expanded, have sufficient contact area to maintain the catheter within the target area within the artery and allow centering of the source wire within the artery. These multiple spherical elements are spaced apart from each other, allowing for blood perfusion beyond the catheter during radiotherapy, even when expanded, with sufficient passage for blood to flow past each individual spherical element. give. These spherical elements maintain the catheter in a very thin profile when the spherical elements are in their unexpanded state, but once in their expanded position, maintain and retain the catheter in the target area. It can be made from an elastic (expandable) material that expands sufficiently. As described below, there are several ways to form these expandable spherical elements on an elongated catheter body to achieve a successful intravascular catheter with hemoperfusion capability.

[0013] The above and other advantages of the present invention will become more apparent from the above detailed description thereof, taken in conjunction with the accompanying exemplary drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides an intravascular catheter that delivers a low-dose radiation source to a body lumen of a patient, such as a coronary artery or other blood vessel, and that maintains the source over a long period of time. Is what you do. The catheter allows perfusion of blood during radiation treatment and centers the radiation source so that an equal amount of radiation strikes the artery. Although the present invention is described in detail as applied to a coronary artery, it will be apparent to those skilled in the art that the present invention may be used in other body cavities, such as peripheral arteries and veins.

1 to 3 show an intravascular catheter assembly 10 to which the present invention is applied. The catheter assembly 10 includes a generally elongated catheter body 11.
, The catheter body 11 has an inflatable region 12 at its distal portion and an adapter 13 at its proximal portion. The inner tubular member 14 extends concentrically within the outer tubular member 15 to define an annular inflatable interior space 16. The inflation volume 16 extends from the proximal end of the elongate catheter body 11 to the inflation region 12 and communicates the interior of the inflation region 12 with a source of inflation fluid at the distal end of the catheter body 11 such that fluid flows there between. Let it. The distal ends of the inner tubular member 14 and the outer tubular member 15 are joined together by a suitable means such as an adhesive or a heat bond to provide a seal of the inflated interior space 16.

The elongate catheter body 11 includes a guidewire cavity 17 located at a distal portion thereof, the guidewire cavity 17 extending from a proximal end of the elongate catheter body 11 to a distal end. A guide wire (not shown) can be slidably disposed in the guide wire inner space 17, so that the catheter 10 in the artery 18 can be advanced or retracted or replaced. As can be seen from FIG. 1, the inflatable region 12 comprises a plurality of separate balloon elements 19 attached to the elongated catheter body 11, which separate balloon elements 19 inflate and deflate simultaneously. It communicates with the expansion inner space 16 so that it can be made.

FIG. 2 is a cross-sectional view showing the separated balloon element 19 in an inflated state in the artery 18. As apparent from FIGS. 2 and 3, each balloon element
It contacts the arterial wall only along the contact surface 21 of the balloon element. As a result, a passageway 22 is created between the arterial wall and the side walls 23, 24 of each balloon element to form a fluid conduit so that blood can flow through each inflated balloon element. The radiation source wire 25 which is advanced in the guide wire space 17 is kept centered in the artery 18. In this way,
During the treatment of radiation administration, blood can be perfused through the distal end of the catheter assembly, allowing for a longer duration of radiation therapy.

As can be seen from FIGS. 1 and 2, the individual balloon elements 19 are oriented at approximately 90 degrees (offset) from the adjacent balloon elements to provide blood perfusion during radiation therapy. Sufficient passage 22 is provided to allow. Each balloon element 19 may be alternately oriented at an angle different from 90 degrees to achieve substantially the same function of creating sufficient flow passages for blood perfusion during radiation therapy. It should be noted that while five balloon elements are shown in the embodiment of FIG. 1, more or fewer balloon elements may be used to implement the present invention. In addition, each separate balloon element is in direct contact with each other, but non-inflated segments are placed between the balloon elements to provide a similar passageway for blood perfusion through the inflation region 12. Can also.

Each balloon element has a small cross-section (thickness) configuration so that a sufficiently large passage can be formed to allow perfusion of blood while the balloon element is inflated. In the embodiment shown in FIGS. 1-3, the side walls 23,
24 is approximately square, so that proper centering of the source wire within the artery is achieved. It should also be understood that the sidewalls 23, 24 can have other shapes, for example rectangular, to properly center the source wire within the artery. Each balloon element, due to its small cross-sectional configuration, is wide enough to contact the artery wall for centering and retention within the artery during its inflated condition, but large enough for blood perfusion. In this case, the contact surface 21 is formed which is small enough to perform the process.
The length and width of these contact surfaces can likewise vary. However, the cross-section (ie, the distance between the two sidewalls) must be large enough to support and retain the catheter in the artery when inflated, and enough to create a sufficient passage for blood to flow. Must be small. The individual balloon elements are offset by 90 degrees from each other so that a sufficiently large passage is formed.

As can be seen from FIGS. 2 and 3, once the intravascular catheter is positioned within the artery 18, a guide wire (not shown) can be removed from the guide wire cavity 17 and the radiation source wire 25 can be removed from the body. Can be inserted into the guidewire cavity 17 for a period of time sufficient to irradiate the lumen of the guidewire. Preferably,
The source wire 25 is hollow at its distal end and contains a radiation dose in the form of a source 26, such as a pellet, a radiation gas, or an activation liquid or activation paste. The radiation source wire 25 may have a radiation source coated at its distal end. The radiation wire 25 applies an appropriate dose of radiation to the area of the artery 18 (in this area, to prevent PTCA, cystectomy, or to prevent neo-intima growth in that area). Arterial intervention has been performed by other means that contribute to With a protective sheath 27 surrounding the source wire 25, the source is sealed from exposure to all bodily fluids, such as blood, so that the source wire 25 (which is reusable and not sterile); A sterile barrier between the patient's vasculature is provided. Preferably, the source wire 25 comprises
Stored by an afterloader known in the art (not shown) and its deployment is controlled.

In operation, once the catheter assembly 10 is positioned within the patient's vasculature, the guidewire can be removed from the guidewire cavity 17 and the protective sheath 27 can be removed using a support mandrel, not shown. It can be made to be able to be loaded into the guide wire. With the protective sheath 27 properly positioned within the guidewire lumen 17, the support mandrel can be removed from the proximal end of the catheter assembly. The source wire 25 is then advanced by the afterloader through the protective sheath to the target area for radiation treatment. Here, the target area is a part of a body lumen, which has undergone PTCA, cystectomy, or similar surgery to reduce or remove stenosis, but has intimal thickening or smooth muscle. Refers to the portion of the lumen that has been exposed to the development of restenosis due in part to cell growth.

When the duration of the treatment is complete, the inflatable region 12 can be deflated and the entire catheter assembly and source wire 25 can be removed from the body lumen. Note that the proximal end of protective sheath 27 may be coupled to an afterloader that can store the source wire during the initial setup procedure of advancing the catheter assembly to the target area. The radiation source wire can then be advanced from the afterloader through the protective sheath to the target area, and the likelihood that a person performing the radiation treatment procedure will be exposed to the radiation source is prevented or reduced.

In another preferred embodiment of the present invention, as shown in FIGS. 4-7, an intravascular catheter utilizes an inflatable region 12 comprising a plurality of bump-like elements 28.
When inflated, the bump-like element 28 extends outwardly from the catheter body 11 and contacts the inner wall 20 of the artery 28 during radiation treatment. With particular reference to FIGS. 7 and 7A, the bump-like element 28 is shown in contact with the artery wall 20 during inflation. Since the bumps 28 are spaced apart from each other and have minimal contact area with the artery wall, a passage 22 is formed to allow blood flow to pass through the bumps when inflated. Each of these bump-like elements 28 provides a centered inflation region 12 of the guidewire cavity 17 while maintaining the catheter in the target area. The centering of the guidewire cavity 17 centers the radiation source wire 25 within the artery during radiation treatment.

Referring to FIGS. 5 and 6, the structure of the inflatable region 12 in the catheter of FIG. 4 is shown in detail. The elongated catheter body 11 has a pair of inflated inner spaces 29,3.
0, these inflated cavities 29, 30 inflate the rows 31, 32 (arranged on both sides of the catheter body 11) of the bump-like elements 28. Each of the inflation cavities 29, 30 is provided with a plurality of openings 33 extending from the outer surface 34 of the catheter body to the corresponding inflation cavities. A thin layer 35 of elastic material is disposed over the outer surface 34 of the elongate catheter body and envelops the distal end of the catheter. An outer sleeve 36 made of a resilient material is placed at the distal end on the thin layer 35 of resilient material. The outer sleeve 36 is provided with a plurality of openings 37 located above the openings 33 of the elongated catheter body 11. When the inflation fluid is pumped into the inflation volumes 29, 30, the inflation fluid causes the thin film layer 35 of elastic material to expand through the openings 37 in the outer sleeve 36, as shown in FIG. Are formed respectively. As the flow pressure of the inflation fluid is increased, the size of the bumps increases accordingly until it contacts the arterial wall, centering and holding the catheter in place. When the catheter is removed from the artery, when the inflation fluid is expelled (purged) from the interior of the inflation, the thin film layer 35 of elastic material returns to its original uninflated shape shown in FIG.

In use, an intravascular catheter having an inflation region 12 is slid using a guidewire already located at the target region, as shown in FIG. Can be located. The inflation region 12 is then inflated such that the nubs are inflated outwardly from the outer surface of the elongate catheter body to contact and press against the arterial wall. The guidewire is then removed from the guidewire cavity 14 so that the protective sheath 27 can be loaded into the guidewire cavity 14 using the support mandrel. Once the protective sheath 27 is in place, the support mandrel is removed and the source wire 25 is advanced to the target area of the artery. Upon completion of the source irradiation procedure, the bumps are deflated and the catheter, source wire and protective sheath are removed from the patient's vasculature.

In yet another embodiment, as shown in FIGS. 8-11A, the catheter comprises:
The inflatable region 12 is comprised of a plurality of bump-like elements 38 extending from an outer surface 39 of the elongate catheter body 11. In the case of the hump in the embodiment of FIGS. 4-7A, the hump 38 is first inflated within the target area of the artery to center the source wire during the procedure while holding the catheter in place. Is to do. In the embodiment shown in FIGS. 9 and 10, each hump element 38 is formed on an outer tubular member 40 that forms part of the elongated catheter body. An inner tubular member 41 extending the entire length of the catheter assembly includes a guidewire cavity 17 formed therein. In this embodiment, the inflated inner space 16 is formed in a space between the outer tubular member 40 and the inner tubular member 41. These hump-like elements 38 are arranged in rows 42 and 43 along the outer tubular member 40, similar to the embodiment of FIGS. 4-7A.

FIG. 9 shows the bump-like element 38 uninflated on the catheter. In this detailed view, the material forming each hump-shaped element is the outer circumferential surface 3 of the outer tubular member 40.
It is folded along 9. In this way, the profile of the entire catheter is modified so that it can be more easily guided in the patient's blood vessels. Thereafter, inflation of the inflation interior space 16 causes the hump elements to expand outwardly, forming the inflation shape shown in FIG. Also, the bumpy balloon element 38 is designed to expand outwardly to contact a portion of the wall 20 of the artery 18, thereby maintaining the catheter in place and maintaining the center of the artery during the procedure. The radiation source wire 25 is centered inside the guide wire so as to be positioned. The particular configuration and use of the bump-like element 38 also secures the passage 22 between the catheter and the vessel wall so that blood flow is ensured during radiation therapy. In this way, the catheter may be left in the patient's blood vessels during the dilation period so that the tissue prior to the catheter is not likely to be damaged due to lack of oxygenated blood.

The inflation regions shown in FIGS. 4 and 6 are approximately one-to-one on the inflation balloon catheter.
Although a particular arrangement of hump-shaped balloon elements in a set of rows arranged at an angle of 80 degrees is shown, the inflation allows for centering of the source wire and ensuring a proper passage for blood flow. It is also possible to stagger the space and orientation of the individual bump-shaped balloon elements along the dilatation catheter body to create the area. The bumps need not be arranged in only two rows, but may be arranged in further rows as desired. In fact, the nubs need not be arranged in rows at all, but rather strategically, the arrangement of the nubs balloon elements cooperate with each other to center the source wires and provide sufficient blood perfusion. It can be positioned around the body of the dilatation catheter so as to ensure a passage of size. Also,
The particular size and shape of the hump balloon element can be varied by employing different shapes and sizes without departing from the spirit and scope of the present invention. In this case, the shape and size of the bump-shaped balloon element in the embodiment shown in FIG. 4 can be easily changed by changing the shape and / or size of the opening 37 in the outer sleeve of the catheter. Similarly, each bump-shaped balloon element formed on the non-deformable region of FIG. 8 can be modified in different sizes and shapes to embody the features of the present invention.

Generally, the size of the catheter assembly of the present invention is substantially the same size as the catheter used in an angioplasty procedure. The overall length of the catheter is about 100
~ 175 cm, and can pass through the femoral artery.
r) When the approach is used, preferably about 135 cm. The diameter of the catheter body may range from about 0.030 to 0.100 inches. The uninflated inflated region has about the same diameter as the catheter body, but may have a maximum diameter of about 1 to about 5 mm for coronary arteries and a substantially larger diameter for peripheral arteries (
For example, it may be 10 mm). The diameter within the guidewire should be substantially greater than the diameter of the guidewire and the guidewire so that the catheter can be easily advanced and removed from the guidewire. Also, the guidewire diameter is such that the two devices can be easily advanced and removed from within the guidewire lumen.
It should be substantially larger than the diameter of the source wire and the protective sleeve.

In use, the inflated area is kept in an inflated state for a time sufficient to effect a radiation dose on those cells that will cause restenosis. Irradiation at a sufficient radiation dose, preferably for about 1 to about 60 minutes, to prevent the occurrence of restenosis. In the inflated state, the inflated region presses, or at least is in close proximity to, the vessel wall, in which state the source wire is centered within the vessel. This centering of the source wire is important in order to receive a uniform dose of radiation as close as possible to all parts of the blood vessel. This positioning also prevents the occurrence of radiation burns or hot spots in the target area.

[0031] The catheter assembly of the present invention as described herein may be used to provide radiation therapy after a nephrectomy, a percutaneous transluminal coronary angioplasty procedure, or where restenosis would otherwise occur within the coronary artery. It is commonly used before or after implanting a stent to deliver a dose. P
After a vascular procedure other than TCA, stent implantation, or resection of the tumor,
It should be understood by those skilled in the art that the catheter of the present invention can be used in the vasculature of a patient.

[0032] The catheter assembly of the present invention may be formed from conventional structural materials as disclosed in detail in the prior art patents referred to herein. The catheter body and protective covering can be made from suitably inelastic materials such as polyethylene, polyvinyl chloride, polyacetate, and blends. The various components are joined by a suitable adhesive such as acrylonitrile based on commercially available adhesives, such as Loctite 405, or other known methods. If appropriate, heat shrink or heat bonding can be used. Also, the present invention can be formed of a material that forms an elastic (expandable) segmented balloon element or a hump balloon element, since compression of the plaque for a particular application is not required. Elastic materials such as latex are optimally used. The source wire is made from materials such as stainless steel, titanium, nickel titanium (NiTi) and platinum nickel alloys, or any NiTi alloy, any polymer and composite.

As described herein, due to the catheter's ability to perfuse blood through the inflated area during the procedure, the present catheter assembly dilates a body lumen, such as a coronary artery, if necessary. It is configured to provide a long term radiation dose.

The radiation applied to the coronary arteries is preferably from about 20 to 3,000 in 30 seconds or more.
Should be in the range of Rado. The dose may be less than 30 seconds, but preferably a longer time frame can be used to provide a more controlled and accurate dose to the target area.

Given the use of different radiation sources, preferred radiation sources include iridium (192) as a gamma emitter and phosphorous (32) as a beta emitter. Further, it is contemplated that the radiation source only needs to be able to supply beta particles or gamma rays that affect target cells. However, alpha radiation sources can also be used, even if the radiation dose does not reach deep into human body cells.
Beta and gamma radiation sources are known for treating and killing cancer cells.

[0036] Other modifications can be made without departing from the spirit and scope of the invention. Specific dimensions, doses, times and material of the components are given by way of example and modifications without departing from the invention are readily conceivable.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an inflatable region of an intravascular catheter embodying features of the present invention.

FIG. 2 is a cross-sectional end view of the catheter of FIG. 1 showing the inflatable region in an expanded state inside an artery.

FIG. 3 is a cross-sectional view of the inflatable region of the catheter of FIG. 1, wherein the inflatable region is expanded within a curved section of the artery, thereby centering the source wire within the artery.

FIG. 4 is a perspective view of one embodiment of an inflatable region of an intravascular catheter embodying features of the present invention.

FIG. 5 is a cross-sectional view of the inflatable region of FIG. 4 in an unexpanded state.

FIG. 6 is a cross-sectional view of the inflatable region of FIG. 4 in an expanded state.

7 is a cross-sectional view of the inflatable region of FIG. 4, wherein the inflatable region is expanded within a curved section of the artery, thereby centering the source wire within the artery.

FIG. 7A is a cross-sectional view of the inflatable region of FIG. 4 taken along line 7A-7A, showing the inflatable region fully expanded inside the artery, thereby centering the source wire.

FIG. 8 is a perspective view of another embodiment of an inflatable region of an intravascular catheter embodying features of the present invention.

9 is a cross-sectional view of the inflatable region of FIG. 8 in an unexpanded state.

FIG. 10 is a cross-sectional view of the inflatable region of FIG. 8 in an expanded state.

FIG. 11 is a cross-sectional view of the inflatable region of FIG. 8 showing the inflatable region expanded inside a curved section of the artery, thereby centering the source wire within the artery.

FIG. 11A is a cross-section of the inflatable region of FIG. 11 taken along line 11A-11A, showing the inflatable region expanded inside a curved section of the artery, thereby centering the source wire inside the artery. FIG.

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] September 16, 1999 (September 16, 1999)

[Procedure amendment 1]

[Document name to be amended] Drawing

[Correction target item name] All figures

[Correction method] Change

[Correction contents]

FIG.

FIG. 2

FIG. 3

FIG. 4

FIG. 5

FIG. 6

FIG. 7

FIG. 7A

FIG. 8

FIG. 9

FIG. 10

FIG. 11

FIG. 11A

────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Lee, Jeon S. United States, 91765, California, Diamond Bar East, Gold Rush Drive, 23637 (72) Inventor Neil, Paul Buoy, United States, 92129, California・ San Diego Truman Street ・ 9179 (72) Inventor Ye, Pin United States ・ 92563 ・ California ・ Marita Via Castanas ・ 39908 F-term (reference) 4C082 AA05 AC03 AC06 AE05 [Continued summary]

Claims (20)

[Claims] 1. A vascular catheter for opening a body lumen for a time sufficient to deliver a radiation dose to the body lumen while performing blood perfusion, the catheter having a distal end and a proximal end. An elongated catheter body, an inflated lumen extending within the elongated catheter body to a position of a distal end portion of the elongated catheter body, and an inflatable lumen positioned near the distal end of the elongated catheter body in fluid communication with the inflated lumen. An inflatable region extending into contact with a body lumen while blood is perfused through the inflatable region; and a guidewire extending through at least a portion of the elongated catheter body to receive a guidewire. It has an empty space and a protective sheath enclosing the radiation source wire, and the protective sheath and the radiation source can be inserted into the space inside the guide wire so as to supply the radiation source to the body cavity. Vascular catheter wherein there. 2. The inflatable region is formed of a plurality of separate balloon elements axially aligned along the elongated catheter body, and includes a first side wall and a second side wall opposite the first side wall and the first side wall. The vascular catheter according to claim 1, further comprising a contact surface connecting the second side wall. 3. The vascular catheter according to claim 2, wherein the first side wall and the second side wall are formed to be substantially square. 4. The vascular catheter according to claim 2, wherein the first side wall and the second side wall are formed in a rectangular shape. 5. The vascular catheter according to claim 2, wherein adjacent balloon elements are positioned 90 degrees apart. 6. The vascular catheter according to claim 2, wherein the balloon element is made of an inflatable material. 7. The vascular catheter according to claim 2, wherein the first side wall and the second side wall are parallel to each other. 8. The vascular catheter according to claim 2, wherein the adjacent balloon elements are offset by 90 degrees. 9. The vascular catheter according to claim 2, wherein the distance between the first side wall and the second side wall is substantially equal to the outer diameter of the elongated catheter body. 10. A vascular catheter for opening a body lumen for a time sufficient to deliver a radiation dose to the body lumen while performing blood perfusion, the catheter having a distal end and a proximal end. A catheter body, an inflated interior extending to a position of a distal end portion of the elongate catheter body in the elongate catheter body, A hump-shaped balloon element, which expands into contact with the body lumen while perfusing blood through the inflatable region thereof, and extends through at least a portion of the elongated catheter body to provide a guidewire and a human body. A vascular catheter having a guide wire receiving a radiation source wire for supplying a radiation source to a body cavity. 11. Further, it can be inserted into an elongated catheter body,
The vascular catheter according to claim 10, further comprising a protective sheath enclosing the radiation source to protect the source wire from any bodily fluids in the body lumen. 12. The vascular catheter according to claim 10, wherein the plurality of bump-shaped balloon elements are arranged in a pair on the outer surface of the catheter body, and the rows of each bump-shaped balloon element are separated from each other. 13. The vascular catheter of claim 10, wherein each hump-shaped balloon element is inflatable from a non-inflated state folded over the outer surface of the elongated catheter body. 14. The vascular catheter according to claim 10, wherein each bump-shaped balloon element is formed of a unitary tube. 15. A vascular catheter for opening a body lumen for a time sufficient to deliver a radiation dose to the body lumen while performing blood perfusion, the catheter having a distal end and a proximal end. An elongated catheter body, an inflation lumen extending within the elongated catheter body to a distal end portion of the elongate catheter body, a plurality of openings extending through the elongation catheter body into the inflation lumen, A thin layer of elastic material disposed over the plurality of openings on the surface near the distal end; and a plurality of openings near the openings formed in the elongated catheter body disposed on the layer of elastic material. An outer sleeve made of an inelastic material provided with an inflating liquid filled in an inflating inner space to inflate the elastic material through an opening of the outer sleeve to form a plurality of hump-shaped balloon elements; An outer sleeve for spreading the element into contact with a portion of the body lumen but perfusing blood through the inflatable region; a proximal end extending through the elongated catheter from the distal end to a guide wire and a source wire; And a vascular catheter having a guidewire for supplying a radiation source to a human body cavity. 16. Further, it can be inserted into an elongated catheter body,
16. The vascular catheter according to claim 15, comprising a protective sheath enclosing the radiation source to protect the radiation source wire from any bodily fluids in the body lumen. 17. The vascular catheter according to claim 15, wherein the plurality of bumpy balloon elements are arranged on the outer surface of the catheter body as a pair of rows, each row of bumpy balloon elements being spaced from one another. 18. The vascular catheter according to claim 15, wherein the shape and size of the opening of the outer tube member determines the shape and size of each hump-shaped balloon element. 19. The vascular catheter according to claim 15, wherein the thin layer of the elastic material forming the hump-shaped balloon element is formed of an elastic material. 20. A method of opening a body lumen to perfuse blood for a time sufficient to deliver a radiation dose into the body lumen, comprising: a) connecting the distal end and the proximal end with each other; An elongate catheter body comprising: an elongate catheter body; an inflated interior extending within the elongate catheter body to a position of a distal end portion of the elongate catheter body; A deployed inflatable region that extends into contact with a body lumen while blood is perfused through the inflatable region; and extends through at least a portion of the elongated catheter body to receive a guidewire. A protective sheath enclosing the guide wire and a radiation source wire, wherein the protective sheath is provided inside the guide wire so as to supply the radiation source to the body cavity. A) a catheter body having a protective sheath into which a source and a radiation source can be inserted; b) positioning a guidewire within the body lumen; c) advancing the catheter along the guidewire; d) following the guidewire. A) elongating the elongated catheter body such that the inflation region is in place in the body lumen, e) inflating the inflatable region into contact with the body lumen and centering the guidewire within the body lumen. F) perfusing blood through and around the inflatable region; g) removing the guidewire from the interior of the guidewire; h) inserting a protective sheath into the interior of the guidewire.