US2003166990A1PendingUtilityA1

Radiation delivery catheters and dosimetry methods

37
Priority: Jan 31, 1997Filed: Dec 9, 2002Published: Sep 4, 2003
Est. expiryJan 31, 2017(expired)· nominal 20-yr term from priority
Inventors:Brett TrauthenLisa TamRobert FazioMichael CrockerEdward F. SmithGary Strathern
A61N 2005/1005A61M 25/1002A61F 2/82A61N 5/1002A61N 2005/1004A61M 2025/1075A61K 51/1282A61K 9/1641Y10S977/949G03C 5/02A61M 25/10G21G 4/06A61K 51/1279
37
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Claims

Abstract

Disclosed are sources and methods for delivering a radioactive dose to a site in a body lumen. The sources are preferably mounted on a balloon or other expandable or deployable mechanical structure. The source and methods enable delivery of a clinically significant dose of radiation into a vessel wall in a relatively short time while using a relatively low activity. The sources also enable delivery of a substantially uniform dose into the vessel wall, whether or not such delivery is through the wall of a stent.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method of optimizing an in stent radiation delivery profile, comprising the steps of: 
 identifying a stent positioned against the wall of a vessel;    positioning a radiation source within the stent; and    exposing the vessel to radiation through the stent such that variations in the dose delivered to a reference depth of at least about 1 mm in the wall of the vessel along the length of the source do not exceed about 20%.    
     
     
         2 . A method of optimizing an in stent radiation delivery profile as in  claim 1 , wherein the variations in the dose delivered to the reference depth in the wall of the vessel along the length of the source do not exceed about 15%.  
     
     
         3 . A method of optimizing an in stent radiation delivery profile as in  claim 1 , wherein the positioning a radiation a source step comprises positioning a source having an activity of no greater than about 60 mCi, and the average dose delivered to a depth of about 1 mm in the wall of the vessel is at least about 8 Gy.  
     
     
         4 . A method of optimizing an in stent radiation delivery profile as in  claim 3 , wherein the exposing step is accomplished in no more than about 15 minutes.  
     
     
         5 . A method of optimizing an in stent radiation delivery profile as in  claim 4 , wherein the exposing step is accomplished in no more than about ten minutes.  
     
     
         6 . A method of optimizing an in stent radiation delivery profile as in  claim 5 , wherein the exposing step is accomplished in no more than about eight minutes.  
     
     
         7 . A method of optimizing an in stent radiation delivery profile as in  claim 1 , wherein the positioning a radiation a source step comprises positioning a source having an activity of no greater than about 200 mCi, and the average dose delivered to a reference depth of about 2 mm in the wall of the vessel is at least about 6 Gy.  
     
     
         8 . A method of optimizing an in stent radiation delivery profile as in  claim 7 , wherein the exposing step is accomplished in no more than about 40 minutes.  
     
     
         9 . A method of optimizing an in stent radiation delivery profile as in  claim 8 , wherein the exposing step is accomplished in no more than about 30 minutes.  
     
     
         10 . A method of optimizing an in stent radiation delivery profile as in  claim 9 , wherein the exposing step is accomplished in no more than about 20 minutes.  
     
     
         11 . A radiation delivery catheter for in stent delivery of a substantially uniform dose of radiation, comprising: 
 an elongate, flexible, tubular body, having a proximal end and a distal end; and    a radiation source near the distal end;    wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm in tissue behind the stent along a length of at least about 30% of the length of the source.    
     
     
         12 . A radiation delivery catheter as in  claim 11 , wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm in tissue behind the stent along a length of at least about 60% of the length of the source.  
     
     
         13 . A radiation delivery catheter as in  claim 12 , wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm in tissue behind the stent along a length of at least about 75% of the length of the source.  
     
     
         14 . A method of treating a coronary vessel to inhibit restenosis, comprising delivering radiation at a dose of at least about 8 Gy, at a depth of 1 mm into the vessel wall, over a time of less than about 15 minutes.  
     
     
         15 . A method of treating a peripheral vessel to inhibit restenosis, comprising delivering radiation at a dose of at least about 6 Gy, at a depth of 2 mm into the vessel wall, over a time of less than about 40 minutes.  
     
     
         16 . A radiation delivery catheter, for delivering a dose of radiation within a vessel, comprising: 
 an elongate flexible body, having a proximal end and a distal end; and    a radiation source carried by the body near the distal end thereof;    wherein the source is configured to deliver a dose in excess of about 8 Gy at a depth of 1 mm into the vessel wall over a time period of no more than about 15 minutes.    
     
     
         17 . A radiation delivery catheter, for delivering a dose of radiation within a peripheral vessel, comprising: 
 an elongate flexible body, having a proximal end and a distal end; and    a radiation source carried by the body near the distal end thereof;    wherein the source is configured to deliver a dose in excess of about 6 Gy at a depth of 2 mm into the vessel wall over a time period of no more than about 40 minutes.    
     
     
         18 . A method of optimizing radiation dose uniformity in a vessel wall behind a stent, comprising the steps of: 
 positioning a radiation delivery catheter within a stent in a body vessel; delivering a first dose of beta radiation along a first axis past a first side of a stent strut and into the vessel wall; and    delivering a second dose of beta radiation along a second axis past a second side of the strut and into the vessel wall;    wherein the first axis and the second axis converge behind the strut.    
     
     
         19 . A method as in  claim 18 , wherein the convergence point is at a depth of no more than about 3 mm.  
     
     
         20 . A method as in  claim 19 , wherein the convergence point is at a depth of no more than about 2 mm.  
     
     
         21 . A method as in  claim 18 , wherein a dose of at least about 8 Gy is delivered at a depth of about 1 mm.  
     
     
         22 . A method as in  claim 18 , wherein the dose depth profile varies by less than 10% along the length of the source inside the 90% isodose crossing of the horizontal plane.  
     
     
         23 . A method of optimizing an intraluminal radiation delivery profile, comprising the steps of: 
 identifying a treatment site in the wall of a vessel;    positioning a radiation source against the wall; and    exposing the vessel to radiation such that variations in the dose delivered to a reference depth of at least about 1 mm in the wall of the vessel along the length of the source do not exceed about 20%.    
     
     
         24 . A method of optimizing an intraluminal radiation delivery profile as in  claim 23 , wherein the variations in the dose delivered to a reference depth of at least about 1 mm in the wall of the vessel along the length of the source do not exceed about 15%  
     
     
         25 . A method of optimizing an intraluminal radiation delivery profile as in  claim 23 , wherein the positioning a radiation a source step comprises positioning a source having an activity of no greater than about 60 mCi, and the average dose delivered to a depth of about 1 mm in the wall of the vessel is at least about 8 Gy.  
     
     
         26 . A method of optimizing an intraluminal radiation delivery profile as in  claim 25 , wherein the exposing step is accomplished in no more than about 15 minutes.  
     
     
         27 . A method of optimizing an intraluminal radiation delivery profile as in  claim 25 , wherein the exposing step is accomplished in no more than about ten minutes.  
     
     
         28 . A method of optimizing an intraluminal radiation delivery profile as in  claim 25 , wherein the exposing step is accomplished in no more than about eight minutes.  
     
     
         29 . A method of optimizing an intraluminal radiation delivery profile as in  claim 23 , wherein the positioning a radiation a source step comprises positioning a source having an activity of no greater than about 200 mCi, and the average dose delivered to a depth of about 2 mm in the wall of the vessel is at least about 6 Gy.  
     
     
         30 . A method of optimizing an intraluminal radiation delivery profile as in  claim 29 , wherein the exposing step is accomplished in no more than about 40 minutes.  
     
     
         31 . A method of optimizing an intraluminal radiation delivery profile as in  claim 29 , wherein the exposing step is accomplished in no more than about 30 minutes.  
     
     
         32 . A method of optimizing an intraluminal radiation delivery profile as in  claim 29 , wherein the exposing step is accomplished in no more than about 20 minutes.  
     
     
         33 . A radiation delivery catheter for delivering a substantially uniform dose of radiation, comprising: 
 an elongate, flexible, tubular body, having a proximal end and a distal end; and    a radiation source near the distal end;    wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm into the wall of the vessel along a length of at least about 30% of the length of the source.    
     
     
         34 . A radiation delivery catheter as in  claim 33 , wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm into the wall of the vessel along a length of at least about 60% of the length of the source.  
     
     
         35 . A radiation delivery catheter as in  claim 33 , wherein the source is capable of a substantially uniform delivery of radiation at a reference depth of at least about 1 mm into the wall of the vessel along a length of at least about 75% of the length of the source.  
     
     
         36 . A method of treating a site in a vessel, comprising delivering radiation at a dose of at least about 8 Gy, at a depth of 1 mm into the vessel wall, over a time of no more than about 15 minutes.  
     
     
         37 . A method of treating a vessel as in  claim 36 , wherein the time is no more than about 10 minutes.  
     
     
         38 . A method of treating a vessel as in  claim 36 , wherein the time is no more than about 8 minutes.  
     
     
         39 . A method of treating a vessel as in  claim 36 , wherein variations in the delivered dose at a depth of 1 mm do not exceed about 20%.  
     
     
         40 . A method of treating a vessel as in  claim 39 , wherein variations in the delivered dose at a depth of 1 mm do not exceed about 15%.  
     
     
         41 . A method of treating a vessel as in  claim 36 , wherein the delivering step comprises delivering radiation from a source having an activity of no more than about 60 mCi.  
     
     
         42 . A method of treating a vessel as in  claim 36 , wherein the delivering step comprises delivering radiation from a source having an activity of no more than about 200 mCi.  
     
     
         43 . A method of treating a vessel as in  claim 36 , wherein the delivering step comprises positioning a source against the vessel wall.  
     
     
         44 . A method of treating a vessel as in  claim 43 , wherein the positioning step is accomplished by inflating a balloon.  
     
     
         45 . A method of treating a vessel as in  claim 44 , further comprising the steps of deflating the balloon to permit perfusion and reinflating the balloon.  
     
     
         46 . A method of treating a vessel as in  claim 36 , wherein the site is in a coronary artery.  
     
     
         47 . A method of treating a vessel as in  claim 36 , wherein the site is in a coronary artery bypass graft.  
     
     
         48 . A method of treating a vessel as in  claim 44 , wherein the source is attached to the balloon.

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