Devices and methods for radiation treatment of an internal body organ
First Claim
Patent Images
1. A catheter system comprising:
- an elongate catheter body having a proximal end and a distal end;
at least one radioactive element operably attached to the catheter body near the distal end;
an expansible member which radially expands the radioactive element away from the catheter body and toward a vessel wall; and
an energy attenuator disposed about at least a portion of the radioactive element so as to produce a generally uniform circumferential radiation dose distribution having a lesser radial energy gradient at the vessel wall upon expansion of the expansible member.
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Abstract
The invention provides methods and devices for delivering low level radiation to inhibit neointimal hyperplasia following angioplasty or other intravascular procedures. In an exemplary method, a balloon is inflated within a stenosed region of a blood vessel to produce a treated region. The balloon is then deflated and a radioactive source within a sleeve is aligned over the deflated balloon. The balloon is again inflated at the treated region to engage the sleeve having the radioactive source against the blood vessel within the treated region for from 1 to 40 minutes to deliver a sufficient dose of radiation to inhibit neointimal hyperplasia.
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Citations
122 Claims
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1. A catheter system comprising:
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an elongate catheter body having a proximal end and a distal end; at least one radioactive element operably attached to the catheter body near the distal end; an expansible member which radially expands the radioactive element away from the catheter body and toward a vessel wall; and an energy attenuator disposed about at least a portion of the radioactive element so as to produce a generally uniform circumferential radiation dose distribution having a lesser radial energy gradient at the vessel wall upon expansion of the expansible member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method for providing radiation therapy to a patient, the method comprising:
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performing angioplasty on a coronary artery to produce a treatment region; introducing a catheter to the treatment region, the catheter comprising a catheter body having a proximal end and a distal end, at least one radioactive element operably attached to the catheter body near the distal end and a balloon; and inflating the balloon when at the treatment region to radially move the radioactive element toward the artery so that the radioactive element is spaced apart from the artery wall by a predetermined distance in the range from about 0.25 mm to about 0.5 mm; wherein the irradiation energy from the radiation emitting element is attenuated when travelling outward so as to provide a generally uniform circumferential radiation treatment. to the treatment region. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. A catheter system, comprising:
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an elongate catheter body having a proximal end, a distal end and a longitudinal axis; a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis; at least one radioactive element operably attached to the head; and an expansible member operably attached to the catheter body which radially expands the radioactive element away from longitudinal axis of the catheter body. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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56. A method for providing radiation therapy to a patient, the method comprising:
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performing angioplasty on a body lumen to produce a treatment region; providing a catheter comprising an elongate catheter body having a proximal end, a distal end, a longitudinal axis, a head adapted for attachment to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis, at least one radioactive elements operably attached to the head, and an expansible member operably attached to the head, with the head being aligned with the longitudinal axis; fixedly attaching the head to the catheter body; introducing the catheter to the treatment region; inflating the balloon when at the treatment region to move the radioactive element towards the body lumen. - View Dependent Claims (57, 58, 59, 60, 64, 65)
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61. A catheter comprising:
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an elongate catheter body having a proximal end and a distal end; a radially expansible member near the distal end; a radially expansible sleeve which is positionable over the expansible member to allow the sleeve to be radially expanded by the expansible member; and a plurality of seeds operably attached to the sleeve, each seed comprising an elongate flexible housing having an axial lumen and a plurality of radionuclides, and wherein a row of the radionuclides is housed within each lumen. - View Dependent Claims (62, 63, 66, 67, 68, 69, 70, 71, 72, 73)
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74. A catheter comprising:
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an elongate catheter body having a proximal end and a distal end; an elastomeric balloon near the distal end of the catheter body; and at least one radioactive element integrally formed within the elastomeric balloon such that the radioactive element is evenly circumferentially spaced about the balloon when expanded. - View Dependent Claims (75, 76, 77)
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78. A catheter system comprising:
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a catheter comprising a catheter body having a proximal end, a distal end, and a longitudinal axis; a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis; an elastomeric balloon operably attached to the head of the catheter body; and a plurality of seeds, each seed comprising an elongate flexible housing having an axial lumen and a plurality of radionuclides within the lumen; wherein the seeds are integrally formed within the elastomeric balloon such that the seeds are evenly circumferentially spaced about the balloon when expanded. - View Dependent Claims (79)
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80. A method for providing radiation therapy to a patient, the method comprising:
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performing angioplasty on a body lumen to produce a treatment region; introducing a catheter system to the treatment region, the catheter system comprising a catheter having a catheter body defining a central lumen, a balloon, and a sleeve having an expansible region and a plurality of radioactive elements which are generally disposed over and aligned with the balloon; inflating the balloon when at the treatment region; and introducing a radioactive member through the central lumen so that the radioactive member is axially aligned with the radioactive elements of the sleeve to provide a generally uniform circumferential radiation dose to the treatment region. - View Dependent Claims (81, 82, 83, 84)
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85. A radiation emitting catheter system, comprising:
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an elongate catheter body having a proximal end, a distal end and a central lumen; an elastomeric balloon attached near the distal end of the catheter body; at least one radiation emitting element attached to the elastomeric balloon; and a guide wire which is receivable in the central lumen. - View Dependent Claims (86, 87, 88, 89)
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90. A method for performing angioplasty, the method comprising:
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introducing an angioplasty catheter having an angioplasty balloon to a body lumen and inflating the angioplasty balloon to produce a treatment region; removing the angioplasty catheter from the patient; introducing a radiation emitting catheter having a central lumen, an elastomeric balloon and a plurality of radiation emitting elements around the elastomeric balloon to the treatment region and inflating the elastomeric balloon to provide radiation treatment to the treatment region. - View Dependent Claims (91, 92, 93, 94, 95, 96)
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97. A catheter system comprising:
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a balloon catheter having a catheter body with a proximal end, a distal end, a lumen extending therebetween, and a balloon disposed near the distal end; a sleeve having a radially expansible and contractible region, wherein at least one radioactive element is evenly distributed about the expansible region; and wherein the catheter body includes orifices proximal and distal to the balloon for allowing blood to pass by the balloon through the lumen. - View Dependent Claims (98, 99, 100, 101, 102, 103, 104)
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105. A method for providing radiation therapy to a patient, the method comprising:
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performing angioplasty on a body lumen to produce a treatment region; introducing a catheter to the treatment region, the catheter comprising a catheter body having a central lumen, a balloon, and a sleeve having an expansible and contractible region disposed over the balloon, wherein the sleeve includes at least one radioactive elements distributed about the sleeve so as to be axially aligned with the balloon, and wherein the catheter body includes perfusion orifices proximal to the balloon; and aligning the balloon and the sleeve with the treatment region and inflating the balloon, wherein blood is allowed to flow through the treatment region of the coronary artery by passing through the perfusion orifices and the central lumen. - View Dependent Claims (106, 107, 108, 109)
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110. A catheter system comprising:
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a balloon catheter having a catheter body with a proximal end, a distal end, a lumen extending therebetween, and a balloon disposed near the distal end; a perfusion catheter having a radially deployable and contractible balloon containment region which defines an axial lumen and at least one perfusion lumen; at least one radioactive element distributed about the radially deployable region; and wherein the balloon catheter is insertable into the axial lumen of the perfusion catheter, wherein the balloon is expansible within the radially deployable region to move the radioactive element radially outward while allowing blood to flow past the inflated balloon through the perfusion lumen, and wherein the balloon containment region is contractible upon deflation of the balloon. - View Dependent Claims (111, 112, 113, 114)
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115. A catheter system comprising:
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an elongate housing which is folded into an expansible cage structure; at least one radioactive element disposed within the housing; and an elongate push rod having a proximal end and a distal end, wherein the distal end is operably attached to the housing, and wherein the push rod is sufficiently rigid to allow the rod to be pushed from the proximal end to move the distal end through a body lumen. - View Dependent Claims (116, 117, 118)
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119. A method for providing radiation therapy to a patient, the method comprising:
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performing angioplasty on a body lumen to produce a treatment region; providing a catheter having a catheter body defining an inflation lumen and a balloon; placing an expansible cage structure over the balloon, the cage structure comprising a folded elongate housing and at least one radioactive element disposed within the housing, wherein an elongate push rod having a proximal end and a distal end is attached to the cage structure at the distal end; introducing the combined catheter and cage structure to the treatment region and inflating the balloon; and manipulating the proximal end of the push rod which is outside of the body lumen to manipulate the cage structure when within the body lumen. - View Dependent Claims (120, 121)
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122. A catheter system, comprising:
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an elongate catheter body having a proximal end, a distal end; a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body; at least one radioactive element operably attached to the head; an expansible member operably attached to the catheter body which radially expands the radioactive element away from a central axis of the catheter body; and a docking module defining an enclosure for housing the head, the docking module absorbing the release of radioactive energy from the radioactive element.
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Specification