Intravascular catheter device and method for simultaneous local delivery of radiation and a therapeutic substance

• US 6,645,135 B1
• Filed: 03/30/2001
• Issued: 11/11/2003
• Est. Priority Date: 03/30/2001
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Bhat, Vinayak D.
• Primary Examiner(s): CAMPBELL, THOR S
• Application Number:
  US09/823,426
• Time in Patent Office: 956 Days
• Field of Search: 600/3, 600/7, 600/8, 604/19-22, 604/95-103, 606/194
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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: 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

Methods and devices for providing intravascular local radiation therapy and simultaneous local delivery of a solution of a therapeutic substance are disclosed. The therapeutic substance may be an antiplatelet substance, an antithrombotic substance, a thrombolytic substance, or a mixture thereof, among other possibilities. An exemplary balloon catheter assembly for delivery of the simultaneous radiation and therapeutic substance treatments includes an elongate body with lumen for delivering the solution of the therapeutic substance to a permeable inflation region at a distal end of the body, and a centerable delivery lumen for transporting a radiation source to the treatment site.

Claims

1. An intravascular catheter assembly comprising:

a body including

a first end adapted to remain external to a patient'"'"'s body;

an opposite second end including a porous inflation region adapted to be positioned at a treatment site within a vascular lumen of said patient'"'"'s body;

one or more first lumens that deliver a solution that inflates said inflation region and passes through said pores to said treatment site; and

a second lumen, wherein said porous inflation region is adapted to center said second lumen in said vascular lumen at said treatment site upon the inflation of said porous inflation region; and

a radiation source adapted to be delivered through said second lumen from said first end to said second end of said body to provide a radiation treatment at said treatment site.

2. The intravascular catheter assembly of claim 1, wherein said second lumen is adapted to prevent exposure of said radiation source to bodily fluids.

3. The intravascular catheter assembly of claim 1, wherein said inflation region comprises at least three lobes, said lobes adapted to contact said vascular lumen when said inflation region is inflated.

4. The intravascular catheter assembly of claim 3, wherein each of said lobes is in fluid communication with at least one of said first lumens.

5. The intravascular catheter assembly of claim 3, wherein said body includes a single first lumen for delivery of the solution to said at least three lobes.

6. The intravascular catheter assembly of claim 1, wherein said inflation region comprises a spiral balloon wound about the central axis of said second lumen.

7. An intravascular device comprising:

a catheter body including

a first end adapted to remain external to a patient'"'"'s body, and

an opposite second end including an inflation region, said inflation region including a substantially impermeable internal balloon, a permeable external balloon disposed over said internal balloon, and a first lumen, a second lumen, and a third lumen disposed within said catheter body,

wherein said internal balloon is adapted to inflate by delivery of a solution from said first end through said first lumen and to center said third lumen along a central axis of said vascular lumen, and said external balloon is adapted to inflate by delivery of a second solution from said first end through said second lumen and to deliver said second solution to a treatment site through said external balloon;

a radiation source adapted to be delivered through said third lumen from said first end to said second end to provide a radiation treatment at said treatment site; and

a stent positioned over said external balloon of the inflation region.

8. The intravascular device of claim 7, wherein said third lumen is adapted to prevent exposure of the radiation source to bodily fluids.

9. An intravascular catheter assembly, comprising:

a body including

a first end adapted to remain external to a patient'"'"'s body;

an opposite second end adapted to be positioned at a treatment site within a vascular lumen of said patient'"'"'s body, said second end having a first elongated balloon, a second elongated balloon and a third elongated balloon, wherein at least one of said balloons is porous; and

one or more first lumens disposed along a length of said body that deliver a solution that inflates said at least one porous balloon and passes through the pores of said balloon to said treatment site, and

a second lumen disposed along a length of said body, wherein said first, second and third balloons are positioned along a length of said second lumen and are radially spaced from each other such that said balloons center said second lumen in said vascular lumen at said treatment site upon the inflation of said first, second and third balloons; and

a radiation source adapted to be delivered through said second lumen from said first end to said second end of said body to provide a radiation treatment at said treatment site.

10. The intravascular catheter assembly of claim 9, wherein said second lumen is adapted to prevent exposure of the radiation source to bodily fluids.