US5840008A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Radiation emitting sleeve catheter and methods
Assignee: LocalMed Inc
•
Filing: 1995-11-13
•
Granted: 1998-11-24
•
Expires: 2015-11-13
Abstract
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 dosage of radiation to inhibit neointimal hyperplasia.
Inventors
- 👤 Enrique J. Klein
- 👤 Aaron V. Kaplan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 05:10
CPC Classifications
A; A61; A61N; A61N5/00; A61N5/10; A61N5/1001; A61N5/1002; A61B; A61B17/00; A61B17/22; A61B2017/22051; A61B2017/22065; A61B2017/22068; A61M; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/1047; A61N2005/1004; A61N2005/1005; A61N5/1014; A61N2005/1018; A61N2005/1019; A61N2005/1023; A61N2005/1025
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
58 words
A radiation-emitting device adapted for use in combination with a balloon catheter having a balloon at a distal end said device comprising: structure which is adapted to be removably securable over the balloon and expansible upon balloon inflation, and wherein the balloon-securable structure is collapsible upon balloon deflation; and a radioactive source on or within the balloon-securable structure.
Claim 2
Dependent Claim
58 words
A radiation-emitting device adapted for use in combination with a balloon catheter having a balloon at a distal end said device comprising: structure which is adapted to be removably securable over the balloon and expansible upon balloon inflation, and wherein the balloon-securable structure is collapsible upon balloon deflation; and a radioactive source on or within the balloon-securable structure.
Claim 3
Dependent Claim
28 words
A device as in claim 1, wherein the radioactive source comprises a radioisotope selected from the group consisting of 192 Iridium, 90 Yttrium, 90 Strontium, and 125 Iodine.
Claim 4
Dependent Claim
35 words
A device as in claim 1, wherein the radioactive source comprises a plurality of discrete elements, and further comprising a means for uniformly aligning the discrete elements over the balloon when the balloon is inflated.
Claim 5
Dependent Claim
17 words
A device as in claim 3, wherein said discrete elements are integrally formed within the aligning means.
Claim 6
Dependent Claim
14 words
A device as in claim 1, wherein the radioactive source comprises a solid substance.
Claim 7
Dependent Claim
15 words
A device as in claim 5, wherein the solid comprises a plurality of elongate elements.
Claim 8
Dependent Claim
22 words
A device as in claim 1, wherein the structure comprises a radially expansible sleeve having an internal lumen for receiving the balloon.
Claim 9
Dependent Claim
16 words
A device as in claim 7, wherein the sleeve is axially split to permit radial expansion.
Claim 10
Dependent Claim
22 words
A device as in claim 7, wherein the sleeve is formed at least partially of an elastomeric material to permit radial expansion.
Claim 11
Dependent Claim
21 words
A device as in claim 7, wherein the sleeve is formed at least partially from a mesh which permits radial expansion.
Claim 12
Dependent Claim
15 words
A device as in claim 7, wherein the sleeve is folded to permit radial expansion.
Claim 13
Dependent Claim
14 words
A device as in claim 7, further comprising an elastomeric tube around the sleeve.
Claim 14
Dependent Claim
15 words
A device as in claim 7, wherein the sleeve is slideably received over the balloon.
Claim 15
Dependent Claim
27 words
A device as in claim 3, wherein the discrete elements become radiopaque upon absorption of X-radiation from a fluoroscope to permit fluoroscopic imaging of the discrete elements.
Claim 16
Dependent Claim
16 words
A device as in claim 1, further comprising at least one radiopaque marker on the structure.
Claim 17
Dependent Claim
71 words
A radiation-emitting sleeve catheter system comprising: a shaft having a proximal end and a distal end; a radially expansible and collapsible sleeve disposed at the distal end of the shaft, said sleeve having an internal lumen for receiving a balloon on a balloon catheter to allow the. sleeve to be expanded upon balloon inflation and to be collapsed upon balloon deflation; and a radioactive source secured to the radially expansible sleeve.
Claim 18
Dependent Claim
71 words
A radiation-emitting sleeve catheter system comprising: a shaft having a proximal end and a distal end; a radially expansible and collapsible sleeve disposed at the distal end of the shaft, said sleeve having an internal lumen for receiving a balloon on a balloon catheter to allow the. sleeve to be expanded upon balloon inflation and to be collapsed upon balloon deflation; and a radioactive source secured to the radially expansible sleeve.
Claim 19
Dependent Claim
19 words
A radiation-emitting sleeve catheter system as in claim 16, wherein the radioactive source is integrally formed within the sleeve.
Claim 20
Dependent Claim
33 words
A radiation-emitting sleeve catheter system as in claim 16, wherein the radioactive source comprises a plurality of elongate elements that are substantially uniformly distributed over the sleeve when the balloon is inflated therein.
Claim 21
Dependent Claim
19 words
A radiation-emitting sleeve catheter system as in claim 18, wherein the elements are axially aligned with the internal lumen.
Claim 22
Dependent Claim
25 words
A radiation-emitting sleeve catheter system as in claim 19, wherein the elements each have a length in the range from 15 mm to 45 mm.
Claim 23
Dependent Claim
30 words
A radiation-emitting sleeve catheter system as in claim 16, wherein the radially expansible sleeve further includes at least one perfusion lumen for providing blood flow past the balloon when inflated.
Claim 24
Dependent Claim
18 words
A radiation-emitting sleeve catheter system as in claim 16, further comprising a therapeutic drug included in the sleeve.
Claim 25
Dependent Claim
20 words
A radiation-emitting sleeve catheter system as in claim 16, wherein the sleeve includes a side port for introducing the balloon.
Claim 26
Dependent Claim
23 words
A radiation-emitting sleeve catheter system as in claim 16, wherein the shaft comprises a rod at least partially surrounded by a polymer tube.
Claim 27
Dependent Claim
30 words
A radiation-emitting sleeve catheter system as in claim 18, wherein the discrete elements become radiopaque upon absorption of X-radiation from a fluoroscope to permit fluoroscopic imaging of the discrete elements.
Claim 28
Dependent Claim
20 words
A radiation-emitting sleeve catheter system as in claim 16, further comprising at least one radiopaque marker on the expansible sleeve.
Claim 29
Independent Claim
62 words
A method for performing angioplasty, said method comprising: inflating a balloon attached to a shaft within a stenosed region of a blood vessel to produce a treated region; deflating the balloon; placing a radioactive source over the deflated balloon; and reinflating the balloon to engage the radioactive source against or in close proximity to the blood vessel wall within the treated region.
Claim 30
Independent Claim
62 words
A method for performing angioplasty, said method comprising: inflating a balloon attached to a shaft within a stenosed region of a blood vessel to produce a treated region; deflating the balloon; placing a radioactive source over the deflated balloon; and reinflating the balloon to engage the radioactive source against or in close proximity to the blood vessel wall within the treated region.
Claim 31
Dependent Claim
27 words
A method as in claim 27, further comprising delivering a dose of from about 6 Gy to 20 Gy at the treated region with the radioactive source.
Claim 32
Dependent Claim
25 words
A method as in claim 28, further comprising maintaining the radioactive source in the treated region for a period from 1 minute to 40 minutes.
Claim 33
Dependent Claim
15 words
A method as in claim 27, further comprising providing blood flow past the reinflated balloon.
Claim 34
Dependent Claim
27 words
A method as in claim 27, wherein the placing step comprises placing a radially expansible sleeve over the deflated balloon, wherein the sleeve includes the radioactive source.
Claim 35
Dependent Claim
46 words
A method as in claim 31, wherein the placing step further comprises withdrawing the deflated balloon from the blood vessel, placing the sleeve over the balloon shaft while outside of the blood vessel, and reintroducing the deflated balloon to the treated region of the blood vessel.
Claim 36
Dependent Claim
26 words
A method as in claim 32, wherein the placing step further comprises advancing the sleeve over the shaft until the sleeve is aligned over the balloon.
Claim 37
Dependent Claim
21 words
A method as in claim 32, further comprising performing the withdrawing and the reintroducing steps with the assistance of a guidewire.
Claim 38
Dependent Claim
23 words
A method as in claim 32, further comprising rapidly advancing the deflated balloon and the sleeve over the guidewire to reintroduce the balloon.
Claim 39
Dependent Claim
15 words
A method as in claim 27, further comprising delivering a drug to the treated region.
Claim 40
Dependent Claim
26 words
A method as in claim 31, further comprising positioning an elastomeric tube over the radially expansible sleeve, wherein the tube facilitates a uniform collapse of the
References Cited (Backward Citations)
US3324847A
Cited
US3811426A
Cited
US4323055A
Cited
US4581017A
Cited
US4581017B1
Cited
US4584991A
Cited
US4784116A
Cited
US4768507A
Cited
US4790315A
Cited
US4796629A
Cited
US5059166A
Cited
US5199939A
Cited
US5199939B1
Cited
US5213561A
Cited
US5053033A
Cited
US5484384A
Cited
US5302168A
Cited
EP0539136A2
Cited
US5336178A
Cited
US5522961A
Cited
WO1994026205A1
Cited
US5344402A
Cited
WO1995019807A1
Cited
US5503613A
Cited
US5616114A
Cited
US5662580A
Cited
WO1996022121A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-11-23 | 2002-05-25 | 2002-11-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-11-23 | 2006-05-25 | 2006-11-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-11-23 | 2010-05-25 | 2010-11-24 | $7700.00 | Window Closed / Lapsed |