US6099499A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for in vivo radiation delivery and method for delivery
Assignee: Medtronic Inc
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Filing: 1998-04-28
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Granted: 2000-08-08
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Expires: 2018-04-28
Abstract
Abstract A method and an apparatus are provided for delivery of radiation in vivo. A device includes a seal located proximal to a balloon through which a cavity of the balloon is inflated with a composition including a radioactive compound. The seal includes a passage therethrough which provides the only access to the balloon cavity and terminates at the proximal end of the balloon. The passage through the seal provides fluid communication with an inflation lumen within the medical device lumen, wherein a ratio of an inner diameter of the inflatable member to an inner diameter of the inflation lumen is about 0.5 or greater. In such a construction, inflation and evacuation can be accomplished without contamination of the entire medical device lumen. Thus, substantially all of the solution including the radioactive compound can be evacuated from the balloon cavity after treatment due to the positioning of the passage in the seal.
Inventors
- 👤 Sam Ciamacco, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 08:59
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61N; A61N5/00; A61N5/10; A61N5/1001; A61N5/1002; A61M25/0067; A61M25/0074; A61M2025/0079; A61M2025/1043; A61M2025/1079; A61N2005/1019; A61N2005/1021
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
230 words
A medical device for radiation treatment of a body lumen, compromising: an elongated tubular member having an proximal end and a distal end; an inflatable member having a proximal end, distal end, and a inflatable member wall defining a cavity therein being filled with a radioactive compound; an inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member, and is in fluid communication with the cavity of the inflatable member wherein a ratio of an inner diameter of the inflated inflatable member to an inner diameter of the inflation lumen is about 3.33 or greater; and further wherein the inflation lumen contains the radioactive compound; a guidewire lumen having a proximal end and a distal end, the guidewire lumen longitudinally extending through the tubular member; a guidewire access port being connected to the elongated tubular member at the distal end of the tubular member; and a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member with a passage providing a single access to the cavity of the inflatable member via the inflation lumen.
Claim 2
Dependent Claim
230 words
A medical device for radiation treatment of a body lumen, compromising: an elongated tubular member having an proximal end and a distal end; an inflatable member having a proximal end, distal end, and a inflatable member wall defining a cavity therein being filled with a radioactive compound; an inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member, and is in fluid communication with the cavity of the inflatable member wherein a ratio of an inner diameter of the inflated inflatable member to an inner diameter of the inflation lumen is about 3.33 or greater; and further wherein the inflation lumen contains the radioactive compound; a guidewire lumen having a proximal end and a distal end, the guidewire lumen longitudinally extending through the tubular member; a guidewire access port being connected to the elongated tubular member at the distal end of the tubular member; and a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member with a passage providing a single access to the cavity of the inflatable member via the inflation lumen.
Claim 3
Dependent Claim
45 words
The medical device of claim 1 further comprising a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension tube defining an extension tube lumen, the flexible extension tube lumen being in fluid communication with the inflation lumen.
Claim 4
Dependent Claim
77 words
The medical device of claim 1 further comprising a manifold located in proximity to the proximal end of the tubular member, the manifold defining a manifold lumen, the manifold lumen having a proximal end and a distal end wherein the manifold has a first access port at the proximal end of the manifold lumen, the manifold lumen being in fluid communication with the guidewire lumen and a second access port in fluid communication with the inflation lumen.
Claim 5
Dependent Claim
30 words
The medical device of claim 1 wherein the seal is formed from a material selected from the group consisting of a thermoplastic material, a thermosetting material, and a combination thereof.
Claim 6
Dependent Claim
31 words
The medical device of claim 1 wherein the seal is formed from a material selected from the group consisting of an anaerobic adhesive, an aerobic adhesive, and a radiation curable adhesive.
Claim 7
Dependent Claim
30 words
The medical device of claim 1 wherein the seal is formed from a material selected from the group consisting of a cyanoacrylate adhesive, an epoxy resin, and an acrylate adhesive.
Claim 8
Dependent Claim
17 words
The medical device of claim 1 wherein the guidewire access port comprises a single operator exchange port.
Claim 9
Dependent Claim
207 words
A catheter for radiation treatment of a body lumen compromising: a one piece tubular member having a proximal end, a distal end, and a lumen; a balloon having a distal end, a proximal end, an outer surface, and an inner surface defining a cavity therein, the proximal end being attached to the tubular member in proximity to the distal end, wherein the balloon contains a radioactive compound; a guidewire lumen and an inflation lumen longitudinally disposed within the lumen of the tubular member; a seal located in the proximal end of the balloon defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the length of the lumen of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the seal and is filled with the radioactive compound; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen, the flexible extension tube lumen being in fluid communication with the delivery lumen and is filled with radioactive compound.
Claim 10
Dependent Claim
207 words
A catheter for radiation treatment of a body lumen compromising: a one piece tubular member having a proximal end, a distal end, and a lumen; a balloon having a distal end, a proximal end, an outer surface, and an inner surface defining a cavity therein, the proximal end being attached to the tubular member in proximity to the distal end, wherein the balloon contains a radioactive compound; a guidewire lumen and an inflation lumen longitudinally disposed within the lumen of the tubular member; a seal located in the proximal end of the balloon defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the length of the lumen of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the seal and is filled with the radioactive compound; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen, the flexible extension tube lumen being in fluid communication with the delivery lumen and is filled with radioactive compound.
Claim 11
Dependent Claim
37 words
The catheter of claim 8 further comprising a manifold integrally attached to the proximal end of the tubular member, wherein the manifold has an access port in fluid communication with the lumen of the flexible extension member.
Claim 12
Dependent Claim
21 words
The catheter of claim 9 wherein the manifold further comprises a second access port in fluid communication with the guidewire lumen.
Claim 13
Dependent Claim
29 words
The catheter of claim 8 wherein the seal is formed from a material selected from the group consisting of a thermoplastic material, a thermosetting material, and a combination thereof.
Claim 14
Dependent Claim
30 words
The catheter of claim 8 wherein the seal is formed from a material selected from the group consisting of an anaerobic adhesive, an aerobic adhesive, and a radiation curable adhesive.
Claim 15
Dependent Claim
29 words
The catheter of claim 8 wherein the seal is formed from a material selected from the group consisting of a cyanoacrylate adhesive, an epoxy resin, and an acrylate adhesive.
Claim 16
Dependent Claim
16 words
The catheter of claim 8 wherein the seal extends substantially a length of the tubular member.
Claim 17
Dependent Claim
75 words
The catheter of claim 14 wherein the seal is formed from a material selected from the group consisting of a polyurethane, a silicone, a polyester, a polyolefin, a polyisobutylene, an acrylate, a vinyl halide polymer, a polyvinyl ether, a polyvinylidene halide, a polyacrylonitrile, a polyvinyl ketone, a polyvinyl aromatic polymer, a polyvinyl ester, a polyamide, a polycarbonate, a polyimide, an epoxy resin, an alkyd resin, a polyoxymethylene, a polyamide/polyether block copolymer, and a combination thereof.
Claim 18
Dependent Claim
23 words
The catheter of claim 8 wherein the tubular member has a guidewire access port proximal to the distal end of the tubular member.
Claim 19
Independent Claim
213 words
A method for delivery localized radiation in vivo comprising the steps of: providing a catheter compromising: a one piece tubular member having a proximal end, a distal end and a lumen; a balloon having a distal end, a proximal end and a wall defining a cavity therein, the proximal end being sealed to the tubular member; a guidewire lumen and an inflation lumen longitudinally disposed within the tubular member from the proximal end to the distal end; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon, wherein the seal sealingly engages the distal end of the tubular member to the proximal end of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the entire length of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the passage in the seal, wherein a ratio of an inner diameter of the inflated balloon to an inner diameter of the inflation lumen is about 3.33 or greater; positioning the catheter in proximity to a desired in vivo location; and inflating the balloon with a solution including a radioactive material through the delivery lumen.
Claim 20
Independent Claim
213 words
A method for delivery localized radiation in vivo comprising the steps of: providing a catheter compromising: a one piece tubular member having a proximal end, a distal end and a lumen; a balloon having a distal end, a proximal end and a wall defining a cavity therein, the proximal end being sealed to the tubular member; a guidewire lumen and an inflation lumen longitudinally disposed within the tubular member from the proximal end to the distal end; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon, wherein the seal sealingly engages the distal end of the tubular member to the proximal end of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the entire length of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the passage in the seal, wherein a ratio of an inner diameter of the inflated balloon to an inner diameter of the inflation lumen is about 3.33 or greater; positioning the catheter in proximity to a desired in vivo location; and inflating the balloon with a solution including a radioactive material through the delivery lumen.
Claim 21
Dependent Claim
61 words
The method of claim 17 further comprising the steps of: allowing at least a portion of an outer surface of the wall of the balloon to contact the desired in vivo location for a time sufficient to deliver a desired radioactive dose; evacuating the solution including a radioactive material from the balloon through the delivery lumen and disposing of the catheter.
Claim 22
Independent Claim
226 words
A system for in vivo delivery of radiation therapy comprising: a radiation source; and a medical device operably linked to the radiation source, wherein the medical device comprises: an elongated tubular member having an proximal end, a distal end, and a inflatable member wall defining a cavity therein; an inflation lumen adapted for receiving a radioactive compound, the inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member and a passageway providing access to the cavity of the inflatable member via the inflation lumen; a guidewire lumen longitudinally extending substantially from a guidewire access port operatively connected to the elongated tubular member to the distal end of the tubular member; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member, wherein the seal sealingly engages the tubular member to the inflatable member; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen the flexible extension tube lumen being in fluid communication with the inflation lumen.
Claim 23
Independent Claim
226 words
A system for in vivo delivery of radiation therapy comprising: a radiation source; and a medical device operably linked to the radiation source, wherein the medical device comprises: an elongated tubular member having an proximal end, a distal end, and a inflatable member wall defining a cavity therein; an inflation lumen adapted for receiving a radioactive compound, the inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member and a passageway providing access to the cavity of the inflatable member via the inflation lumen; a guidewire lumen longitudinally extending substantially from a guidewire access port operatively connected to the elongated tubular member to the distal end of the tubular member; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member, wherein the seal sealingly engages the tubular member to the inflatable member; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen the flexible extension tube lumen being in fluid communication with the inflation lumen.
Claim 24
Dependent Claim
37 words
The system of claim 19 further comprising a manifold integrally attached to the proximal end of the tubular member, wherein the manifold has an access port in fluid communication with the lumen of the flexible extension member.
Claim 25
Dependent Claim
21 words
The system of claim 20 wherein the manifold further comprises a second access port in fluid communication with the guidewire lumen.
Claim 26
Dependent Claim
87 words
The system of claim 19 further comprising a manifold located in proximity to the proximal end of the tubular member, the manifold defining a manifold lumen, the manifold lumen having a proximal end and a distal end wherein the manifold has a first access port at the proximal end of the manifold lumen, the first access port being in fluid communication with the guidewire lumen and a second access port operably linked to the radiation source, the second access port in fluid communication with the inflation lumen.
Claim 27
Dependent Claim
29 words
The system of claim 19 wherein the seal is formed from a material selected from the group consisting of a thermoplastic material, a thermosetting material, and a combination thereof.
Claim 28
Dependent Claim
30 words
The system of claim 19 wherein the seal is formed from a material selected from the group consisting of an anaerobic adhesive, an aerobic adhesive, and a radiation curable adhesive.
Claim 29
Dependent Claim
29 words
The system of claim 19 wherein the seal is formed from a material selected from the group consisting of a cyanoacrylate adhesive, an epoxy resin, and an acrylate adhesive.
Claim 30
Dependent Claim
16 words
The system of claim 19 wherein the guidewire access port comprises a single operator exchange port.
Claim 31
Dependent Claim
16 words
The system of claim 19 wherein the seal extends substantially a length of the tubular member.
Claim 32
Dependent Claim
75 words
The system of claim 26 wherein the seal is formed from a material selected from the group consisting of a polyurethane, a silicone, a polyester, a polyolefin, a polyisobutylene, an acrylate, a vinyl halide polymer, a polyvinyl ether, a polyvinylidene halide, a polyacrylonitrile, a polyvinyl ketone, a polyvinyl aromatic polymer, a polyvinyl ester, a polyamide, a polycarbonate, a polyimide, an epoxy resin, an alkyd resin, a polyoxymethylene, a polyamide/polyether block copolymer, and a combination thereof.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-08-08 | 2004-02-07 | 2004-08-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-08-08 | 2008-02-07 | 2008-08-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-08-08 | 2012-02-07 | 2012-08-08 | $7700.00 | Window Closed / Lapsed |