US5863284A — Devices and methods for radiation treatment of an…

Claim 1

Independent Claim 91 words

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.

Claim 2

Dependent Claim 91 words

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.

Claim 3

Dependent Claim 30 words

A catheter system as in claim 1, wherein the radioactive element comprises a seed, and wherein the seed comprises a housing and an arrangement of radionuclides contained within the housing.

Claim 4

Dependent Claim 23 words

A catheter system as in claim 2, wherein the radionuclides are spherical in geometry and are arranged in a row within the housing.

Claim 5

Dependent Claim 30 words

A catheter system as in claim 2, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

Claim 6

Dependent Claim 20 words

A catheter system as in claim 2, wherein the seed is uniformly distributed about the periphery of the catheter body.

Claim 7

Dependent Claim 33 words

A catheter system as in claim 2, wherein the seed housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding, and wherein the housing is flexible in the transverse direction.

Claim 8

Dependent Claim 29 words

A catheter system as in claim 2, wherein the seed housing is constructed of a material displaying superelastic properties, and wherein the housing is flexible in the transverse direction.

Claim 9

Dependent Claim 30 words

A catheter system as in claim 7, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

Claim 10

Dependent Claim 35 words

A catheter system as in claim 1, further comprising at least one fluoroscopic marker disposed at a known position relative to the catheter body so that the catheter is visible fluoroscopically within a body lumen.

Claim 11

Dependent Claim 24 words

A catheter system as in claim 2, wherein the housing is constructed at least partially of nickel titanium to make the housing fluoroscopically visible.

Claim 12

Dependent Claim 17 words

A catheter system as in claim 2, further comprising end caps for enclosing and sealing the seed.

Claim 13

Dependent Claim 32 words

A catheter system as in claim 11, wherein the seed housing and the end caps are constructed of a metallic material, and wherein the end caps and the housing are staked together.

Claim 14

Dependent Claim 17 words

A catheter system as in claim 11, wherein the end caps and the housing are welded together.

Claim 15

Dependent Claim 58 words

A catheter system as in claim 2, wherein the seed housing is constructed of a material displaying superelastic properties and includes an eccentric lumen for holding the radionuclides, the eccentric lumen forming an arcuate thick wall portion and an arcuate thin wall portion of the housing, and wherein the attenuator comprises the thick wall portion of the housing.

Claim 16

Dependent Claim 32 words

A catheter system as in claim 2, wherein the seed is cylindrical in geometry, and wherein the attenuator comprises an arcuate eccentric cap positioned around at least a portion of the seed.

Claim 17

Dependent Claim 34 words

A catheter system as in claim 2, wherein the seed is housed within a radiation resistant polymeric channel, and wherein the attenuator comprises a nickel titanium clip which captures the seed within the channel.

Claim 18

Dependent Claim 18 words

A catheter system as in claim 2, wherein the seed is operably attached to the radially expansible member.

Claim 19

Dependent Claim 28 words

A catheter system as in claim 17, wherein the radially expansible member comprises an elastomeric balloon, and wherein the seed is embedded within a wall of the balloon.

Claim 20

Dependent Claim 27 words

A catheter system as in claim 2, further comprising a sleeve which is slidable over the catheter body, and wherein the seed is included in the sleeve.

Claim 21

Dependent Claim 24 words

A catheter system as in claim 19, wherein the sleeve comprises a flexible material which is folded until deployed by the radially expansible member.

Claim 22

Dependent Claim 14 words

A catheter system as in claim 19, wherein the sleeve comprises an elastomeric material.

Claim 23

Dependent Claim 30 words

A catheter system as in claim 19, wherein the sleeve includes a plurality of slits, and wherein the seed is aligned on the sleeve in the direction of the slits.

Claim 24

Dependent Claim 16 words

A catheter system as in claim 2, wherein the radionuclides include 90 Strontium and 90 Yttrium.

Claim 25

Dependent Claim 27 words

A catheter system as in claim 1, wherein the catheter body further comprises a removable head, and wherein the radioactive element is operably attached to the head.

Claim 26

Dependent Claim 39 words

A catheter system as in claim 2, wherein the seed includes a fluoroscopically visible marker which is constructed at least partially of a fluoroscopically visible material selected from the group consisting of nickel titanium, tungsten, gold, platinum, and tantalum.

Claim 27

Dependent Claim 20 words

A catheter system as in claim 1, further comprising a plurality of radioactive elements operably attached to the catheter body.

Claim 28

Dependent Claim 17 words

A catheter system as in claim 2, wherein the seed is folded into an expansible cage structure.

Claim 29

Dependent Claim 30 words

A catheter system as in claim 27, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

Claim 30

Dependent Claim 16 words

A catheter system as in claim 27, wherein the seed is longer than the expansible member.

Claim 31

Independent Claim 135 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 32

Independent Claim 135 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 33

Dependent Claim 25 words

A method as in claim 30, wherein the balloon is constructed of an elastomeric material, and wherein the radioactive element is formed within the balloon.

Claim 34

Dependent Claim 39 words

A method as in claim 30, further comprising a sleeve which is slidable over the catheter body, wherein the radioactive element is housed in the sleeve, and further comprising placing the sleeve over the balloon before inflating the balloon.

Claim 35

Dependent Claim 23 words

A method as in claim 32, wherein the sleeve comprises a flexible material which is folded until deployed by the radially expansible member.

Claim 36

Dependent Claim 29 words

A catheter as in claim 32, wherein the sleeve includes a plurality of slits, and wherein the seed is aligned on the sleeve in the direction of the slits.

Claim 37

Dependent Claim 43 words

A method as in claim 30, wherein the catheter further comprises an attachable head, wherein the radioactive elements are operably attached to the head, and further comprising attaching the head to the catheter body prior to introducing the catheter to the treatment region.

Claim 38

Dependent Claim 22 words

A method as in claim 30, further comprising introducing at least some beta radiation to the treatment region with the radioactive element.

Claim 39

Dependent Claim 25 words

A method as in claim 30, further comprising maintaining the catheter at the treatment region for a period of time not exceeding about three minutes.

Claim 40

Dependent Claim 34 words

A method as in claim 30, wherein the radioactive element comprises a seed, and further comprising removing the seed from the catheter after treating the treatment region and reusing the seed on another catheter.

Claim 41

Dependent Claim 16 words

A method as in claim 38, wherein the seed is folded into an expansible cage structure.

Claim 42

Dependent Claim 14 words

A method as in claim 39, wherein the seed is longer than the balloon.

Claim 43

Dependent Claim 91 words

A catheter system, comprising: 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.

Claim 44

Dependent Claim 91 words

A catheter system, comprising: 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.

Claim 45

Dependent Claim 21 words

A system as in claim 41, wherein the attachment mechanism includes a lock which locks the head to the catheter body.

Claim 46

Dependent Claim 18 words

A system as in claim 41, wherein the catheter body includes an inflation lumen and a guidewire lumen.

Claim 47

Dependent Claim 24 words

A system as in claim 43, wherein the guidewire lumen proximally terminates in a guidewire exit port on a side of the catheter body.

Claim 48

Dependent Claim 24 words

A system as in claim 43, wherein the guidewire lumen terminates at a proximal catheter fitting at the proximal end of the catheter body.

Claim 49

Dependent Claim 38 words

A system as in claim 41, further comprising an energy attenuator which is disposed about at least a portion of the radioactive element so as to produce a generally uniform circumferential radiation dose distribution at a vessel wall.

Claim 50

Dependent Claim 31 words

A system as in claim 41, further comprising a docking module defining an enclosure for housing the head, the docking module absorbing the release of radioactive energy from the radioactive element.

Claim 51

Dependent Claim 23 words

A system as in claim 41, further comprising a packaging enclosure, wherein the head is vacuum or nitrogen packed within the packaging enclosure.

Claim 52

Dependent Claim 27 words

A system as in claim 41, wherein the radioactive element comprise a seed, the seed comprising a housing and a plurality of radionuclides contained within the housing.

Claim 53

Dependent Claim 29 words

A system as in claim 49, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

Claim 54

Dependent Claim 18 words

A system as in claim 49, wherein the seed is uniformly distributed about the periphery of the head.

Claim 55

Dependent Claim 32 words

A system as in claim 49, wherein the seed housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding, and wherein the housing is flexible in the transverse direction.

Claim 56

Dependent Claim 28 words

A system as in claim 49, wherein the seed housing is constructed of a material displaying superelastic properties, and wherein the housing is flexible in the transverse direction.

Claim 57

Dependent Claim 29 words

A system as in claim 53, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

Claim 58

Dependent Claim 25 words

A system as in claim 49, wherein the seed includes end caps which are insertable into ends of the seed housing to seal the seed.

Claim 59

Independent Claim 133 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 60

Independent Claim 133 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 61

Dependent Claim 24 words

A method as in claim 56, further comprising attaching the head to the catheter body while the head is disposed within a radioactive shield.

Claim 62

Dependent Claim 33 words

A method as in claim 56, further comprising attenuating the energy from the radiation emitting element with an attenuator so as to provide a generally uniform circumferential radiation treatment to the treatment region.

Claim 63

Dependent Claim 26 words

A method as in claim 56, further comprising inflating the balloon until the balloon moves the radioactive element to a predetermined distance from the artery wall.

Claim 64

Dependent Claim 34 words

A method as in claim 56, wherein the radioactive element comprise a seed, and further comprising removing the seed from the catheter after treating the treatment region and reusing the seed on another catheter.

Claim 65

Dependent Claim 84 words

A catheter comprising: 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.

Claim 66

Dependent Claim 84 words

A catheter comprising: 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.

Claim 67

Dependent Claim 16 words

A catheter as in claim 61, wherein the seed is folded into an expansible cage structure.

Claim 68

Dependent Claim 13 words

A catheter as in claim 61, wherein the radionuclides are spherical in geometry.

Claim 69

Dependent Claim 15 words

A catheter as in claim 60, wherein the radially expansible member comprises an elastomeric balloon.

Claim 70

Dependent Claim 15 words

A catheter as in claim 60, wherein the seeds are uniformly distributed about the balloon.

Claim 71

Dependent Claim 22 words

A catheter as in claim 61, wherein the flexible housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding.

Claim 72

Dependent Claim 18 words

A catheter as in claim 61, wherein the flexible housing is constructed of a material displaying superelastic properties.

Claim 73

Dependent Claim 15 words

A catheter as in claim 67, wherein the material displaying superelastic properties comprises nickel titanium.

Claim 74

Dependent Claim 19 words

A catheter as in claim 61, wherein the seed includes end caps for enclosing ends of the seed housing.

Claim 75

Dependent Claim 25 words

A catheter as in claim 69, wherein the end caps are constructed of a non-metallic material selected from the group consisting of cyanoacrylates and epoxy.

Claim 76

Dependent Claim 26 words

A catheter as in claim 69, wherein the end caps are constructed of a metallic material and are attached to the housing by cyanoacrylates or epoxies.

Claim 77

Dependent Claim 15 words

A catheter as in claim 61, wherein the radionuclides include 90 Strontium and 90 Yttrium.

Claim 78

Dependent Claim 14 words

A catheter as in claim 72, wherein the radionuclides further include a ceramic material.

Claim 79

Dependent Claim 52 words

A catheter comprising: 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.

Claim 80

Dependent Claim 52 words

A catheter comprising: 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.

Claim 81

Dependent Claim 18 words

A catheter as in claim 74, further comprising a plurality of radioactive elements integrally formed within the balloon.

Claim 82

Dependent Claim 42 words

A catheter as in claim 74, wherein the radioactive element comprises a seed, the seed comprising an elongate flexible housing having an axial lumen and a row of radionuclides within the lumen, and wherein the seed is integrally formed within the balloon.

Claim 83

Dependent Claim 16 words

A catheter as in claim 76, wherein the seed is folded into an expansible cage structure.

Claim 84

Dependent Claim 118 words

A catheter system comprising: 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.

Claim 85

Dependent Claim 118 words

A catheter system comprising: 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.

Claim 86

Dependent Claim 33 words

A catheter system as in claim 78, further comprising a docking module defining an enclosure for housing the head and the balloon, the docking module absorbing the release of energy from the seeds.

Claim 87

Independent Claim 114 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 88

Independent Claim 114 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 89

Dependent Claim 25 words

A method as in claim 80, wherein the radioactive elements of the sleeve are generally evenly distributed around the circumference of the balloon when inflated.

Claim 90

Dependent Claim 38 words

A method as in claim 80, wherein the catheter is introduced over a first guide wire, and further comprising removing the first guide wire after inflating the balloon, and introducing a second guide wire having the radioactive member.

Claim 91

Dependent Claim 38 words

A method as in claim 82, further comprising fluoroscopically visualizing the catheter and the second guide wire when introducing the catheter to the treatment region to align the radioactive elements and the radioactive member with the treatment region.

Claim 92

Dependent Claim 68 words

A method as in claim 80, wherein the radioactive elements and the radioactive member emit at least some beta radiation, and further comprising maintaining the combined catheter and sleeve at the treatment region for a time in the range from about 1 min to about 3 min to achieve a dose of from about 5 Gy to about 50 Gy at a luminal surface of the body lumen.

Claim 93

Dependent Claim 55 words

A radiation emitting catheter system, comprising: 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.

Claim 94

Dependent Claim 55 words

A radiation emitting catheter system, comprising: 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.

Claim 95

Dependent Claim 53 words

A system as in claim 85, wherein the guide wire includes a radiation emitting source, the guide wire being adapted to be received in the central lumen with the radiation emitting source being surrounded by the radiation emitting element on the balloon so as to produce a generally uniform circumferential radiation dose distribution.

Claim 96

Dependent Claim 51 words

A system as in claim 85, further comprising a plurality of radiation emitting elements, wherein the radiation emitting elements are disposed within polymeric housings, and wherein the housings are evenly distributed about the periphery of the balloon, whereby the radiation emitting elements are evenly circumferentially spaced when the balloon is inflated.

Claim 97

Dependent Claim 29 words

A system as in claim 85, wherein the radioactive element comprises a seed, and wherein the seed comprises a housing and a row of radionuclides contained within the housing.

Claim 98

Dependent Claim 37 words

A system as in claim 85, wherein the balloon is constructed of materials selected from the group consisting of polyurethane, natural rubbers and synthetic rubbers, wherein the catheter body centers the radiation emitting source within the balloon.

Claim 99

Independent Claim 77 words

A method for performing angioplasty, the method comprising: 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.

Claim 100

Independent Claim 77 words

A method for performing angioplasty, the method comprising: 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.

Claim 101

Dependent Claim 32 words

A method as in claim 90, further comprising introducing a radioactive source through the central lumen so that the radioactive source is axially aligned with the radioactive elements on the elastomeric balloon.

Claim 102

Dependent Claim 26 words

A method as in claim 90, wherein the radioactive elements on the elastomeric balloon are evenly distributed around the circumference of the elastomeric balloon when inflated.

Claim 103

Dependent Claim 54 words

A method as in claim 91, wherein the angioplasty catheter is introduced over a first guide wire, and further comprising removing the angioplasty balloon after inflating the angioplasty balloon, introducing the radiation emitting catheter over the first guide wire, removing the first guide wire, and introducing a second guide wire having the radioactive source.

Claim 104

Dependent Claim 47 words

A method as in claim 93, further comprising fluoroscopically visualizing the radiation emitting catheter and the second guide wire when introducing the radiation emitting catheter and the second guide wire to the treatment region to align the radioactive elements and the radioactive member with the treatment region.

Claim 105

Dependent Claim 47 words

A method as in claim 91, wherein the radioactive elements and the radioactive source emit at least some beta radiation, and further comprising maintaining the combined radiation emitting catheter at the treatment region for a time in the range from about 1 min to about 3 min.

Claim 106

Dependent Claim 41 words

A method as in claim 91, wherein the elastomeric balloon is filled with a predetermined volume of fluid to inflate the balloon to a known size, and wherein the inflated elastomeric balloon centers the radiation emitting source within the body lumen.

Claim 107

Dependent Claim 76 words

A catheter system comprising: 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.

Claim 108

Dependent Claim 76 words

A catheter system comprising: 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.

Claim 109

Dependent Claim 33 words

A catheter system as in claim 97, wherein the sleeve includes orifices proximal to the radially expansible region to allow blood to flow through the sleeve and to the proximal catheter body orifices.

Claim 110

Dependent Claim 23 words

A catheter system as in claim 98, wherein the sleeve includes axial slits, and wherein the radioactive element is aligned with the slits.

Claim 111

Dependent Claim 18 words

A catheter system as in claim 98, wherein the sleeve is configured to have an offset slitting pattern.

Claim 112

Dependent Claim 34 words

A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material which is disposed about the balloon, and wherein the radioactive element is attached to an outer surface of the sleeve.

Claim 113

Dependent Claim 37 words

A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material which is disposed about the balloon, and wherein the radioactive element is held between an inner surface of the sleeve and the balloon.

Claim 114

Dependent Claim 24 words

A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material and wherein the radioactive element is embedded within the sleeve.

Claim 115

Dependent Claim 20 words

A catheter system as in claim 97, further comprising an elongate rod attached to a proximal end of the sleeve.

Claim 116

Independent Claim 128 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 117

Independent Claim 128 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 118

Dependent Claim 31 words

A method as in claim 105, wherein the sleeve includes orifices proximal to the radially expansible region to allow blood to flow through the sleeve and to the catheter body orifices.

Claim 119

Dependent Claim 27 words

A method as in claim 105, wherein the radioactive element of the sleeve is evenly distributed around the circumference of the balloon when the balloon is inflated.

Claim 120

Dependent Claim 20 words

A method as in claim 105, further comprising fluoroscopically visualizing the catheter when aligning the balloon with the treatment region.

Claim 121

Dependent Claim 40 words

A method as in claim 105, wherein the radioactive element emits at least some beta radiation, and further comprising maintaining the catheter at the treatment region for a time in the range from about 1 min to about 20 min.

Claim 122

Dependent Claim 122 words

A catheter system comprising: 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.

Claim 123

Dependent Claim 122 words

A catheter system comprising: 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.

Claim 124

Dependent Claim 29 words

A catheter system as in claim 110, wherein the perfusion catheter includes orifices proximal and distal to the radially deployable region which are in communication with the perfusion lumen.

Claim 125

Dependent Claim 22 words

A catheter system as in claim 110, further comprising an elastomeric sleeve disposed over the radially deployable region of the perfusion catheter.

Claim 126

Dependent Claim 20 words

A catheter system as in claim 112, wherein the radioactive element is attached to an outer surface of the sleeve.

Claim 127

Dependent Claim 24 words

A catheter system as in claim 112, wherein the radioactive element is held between an inner surface of the sleeve and the perfusion catheter.

Claim 128

Dependent Claim 75 words

A catheter system comprising: 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.

Claim 129

Dependent Claim 75 words

A catheter system comprising: 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.

Claim 130

Dependent Claim 31 words

A catheter system as in claim 115, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the cage structure.

Claim 131

Dependent Claim 52 words

A catheter system as in claim 115, wherein the housing defines a plurality of folded regions where the housing is folded to form the cage structure, and wherein the folded regions have a reduced cross sectional area to facilitate expansion of the cage structure from a collapsed configuration to an expanded configuration.

Claim 132

Dependent Claim 35 words

A catheter system as in claim 115, further comprising a balloon catheter having a proximal end, a distal end, and a balloon near the distal end, wherein the cage structure is positionable over the balloon.

Claim 133

Independent Claim 127 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 134

Independent Claim 127 words

A method for providing radiation therapy to a patient, the method comprising: 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.

Claim 135

Dependent Claim 30 words

A method as in claim 119, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the cage structure.

Claim 136

Dependent Claim 56 words

A method as in claim 119, wherein the housing defines a plurality of folded regions where the housing is folded to form the cage structure, and wherein the folded regions have a reduced cross sectional area to facilitate expansion and the cage structure from a collapsed configuration to an expanded configuration upon inflation of the balloon.

Claim 137

Dependent Claim 92 words

A catheter system, comprising: 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.

Claim 138

Dependent Claim 92 words

A catheter system, comprising: 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.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2002-01-25	2002-07-27	2003-01-26	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2006-01-25	2006-07-27	2007-01-26	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2010-01-25	2010-07-27	2011-01-26	$7700.00	Window Closed / Lapsed

Devices and methods for radiation treatment of an internal body organ

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