Self-expanding medical device for centering radioactive treatment sources in body vessels

• US 6,059,812 A
• Filed: 03/06/1998
• Issued: 05/09/2000
• Est. Priority Date: 03/21/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Clerc, Claude O., Stinson, Jon S.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Truong, Kevin
• Application Number:
  US09/035,954
• Time in Patent Office: 795 Days
• Field of Search: 600/3, 600/1, 606/1, 606/191, 606/198, 606/195, 606/194
• US Class Current: 606/198
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A medical device for treating a body vessel with a radioactive source includes an elongated tubular catheter and an axially flexible support structure on a distal end of the catheter. The catheter has proximal and distal ends, and a lumen for receiving a radioactive source. The support structure is formed from a plurality of filaments which are helically wound and interwoven in a braided configuration and has a plurality of alternately spaced unconstricted and constricted regions. The unconstricted regions are radially compressible and self-expandable from a positioning diameter when the device is in a positioning state to a vessel-engaging, treatment diameter which is greater than the positioning diameter when the device is in the treatment state. The constricted regions are engaged with the catheter and concentric with the unconstricted regions. When in the treatment state the support structure causes the catheter to be substantially radially centered within a vessel so radiation is uniformly applied to the vessel during treatment.

Claims

1. A medical device for treating a body vessel with a radioactive source, including:

an axially flexible support structure formed from a plurality of radiotransparent polymer filaments which are helically wound and interwoven in a braided configuration, the support structure including;

a plurality of spaced unconstricted regions which are radially compressible and self-expandable from a positioning diameter when the device is in a positioning state to a vessel-engaging, treatment diameter which is greater than the positioning diameter when the device is in a treatment state; and

a plurality of spaced constricted regions which are concentric with the unconstricted regions and have a treatment diameter which is less than the treatment diameter of the unconstricted regions when the device is in the treatment state; and

a radioactive source supported within the constricted regions of the support structure when the device is in the treatment state, wherein the device causes the radioactive source to be substantially radially centered within a vessel when in the treatment state.

2. The device of claim 1 and further including expansion limiting structures at the constricted regions for engaging the support structure and limiting the self-expansion of the support structure at the constricted regions.

3. The device of claim 1 wherein the constricted regions are formed by positioning regions of the support structure on a mandrel having the constricted region treatment diameter and heating the regions on the mandrel.

4. The device of claim 1 wherein the constricted regions include heat-treated regions on the support structure.

5. The device of claim 1 wherein:

the device further includes an elongated tubular catheter having proximal and distal ends and a

lumen extending therethrough, wherein the constricted regions of the support structure

are connected to the catheter and the constricted and unconstricted regions of the

support structure are concentric with the catheter when the device is in the treatment

state; and

the radioactive source is located in the catheter lumen adjacent to the support structure.

6. The device of claim 5 wherein the radioactive source is removably insertable into the lumen from the proximal end of the catheter.

7. The device of claim 5 and further including an outer sheath retractably positioned over the tubular catheter and the support structure and movable between positioning and treatent positions, wherein when in the positioning position the outer sheath causes the support structure to be in the positioning state for insertion and removal of the device, and when in the treatment position the outer sheath enables the support structure to self-expand to the treatment state.

8. The device of claim 1 wherein the support structure is formed from nylon filaments.

9. The device of claim 1 wherein the support structure is formed from aramid fiber filaments.

10. The device of claim 1 and further including an outer sheath retractably positioned over the support structure and movable between positioning and treatment positions, wherein when in the positioning position the outer sheath causes the support structure to be in the positioning state for insertion and removal of the device, and when in the treatment position the outer sheath enables the support structure to self-expand to the treatment state.

11. The device of claim 1 wherein the support structure is formed from polyester filaments.

13. The medical device of claim 1 and further including a radioactive source in the lumen of the catheter adjacent to the constricted regions of the support structure.

12. A medical device for treating a body vessel with a radioactive source, including:

an elongated tubular catheter having proximal and distal ends, and a lumen for receiving a radioactive source; and

an axially flexible support structure on a distal end of the catheter and formed from a plurality of radiotransparent polymer filaments which are helically wound and interwoven in a braided configuration, the support structure including;

a plurality of spaced unconstricted regions which are radially compressible and self-expandable from a positioning diameter when the device is in a positioning state to a vessel-engaging, treatment diameter which is greater than the positioning diameter when the device is in a treatment state; and

a plurality of spaced constricted regions which are engaged with the catheter and concentric with the unconstricted regions, wherein the support structure causes the catheter to be substantially radially centered within a vessel when in the treatment state.

14. The medical device of claim 12 and further including a radioactive source removably inserted into the lumen of the catheter.

15. The device of claim 12 and further including expansion limiting structures at the constricted regions for engaging the support structure and limiting the self-expansion of the support structure at the constricted regions.

16. The device of claim 12 wherein the constricted regions are formed by positioning regions of the support structure on a mandrel having the constricted region treatment diameter and heating the regions on the mandrel.

17. The device of claim 12 wherein the constricted regions include heat-treated regions on the support structure.

18. The device of claim 12 and further including an outer sheath retractably positioned over the tubular catheter and the support structure and movable between positioning and treatent positions, wherein when in the positioning position the outer sheath causes the support structure to be in the positioning state for insertion and removal of the device, and when in the treatment position the outer sheath enables the support structure to self-expand to the treatment state.

19. The device of claim 12 wherein the support structure is formed from nylon filaments.

20. The device of claim 12 wherein the support structure is formed from aramid fiber filaments.

21. The device of claim 12 wherein the support structure is formed from polyester filaments.