Adjustable multi-balloon local delivery device

• US 6,575,932 B1
• Filed: 12/01/2000
• Issued: 06/10/2003
• Est. Priority Date: 12/02/1999
• Status: Expired due to Term

• Current Assignee: Ottawa Health Institute, Ottawa Heart Institute Research Corporation
• Original Assignee: Ottawa Health Institute
• Inventors: OʼBrien, Edward, Labinaz, Marino
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): Dagostino, Sabrina
• Application Number:
  US09/728,600
• Time in Patent Office: 921 Days
• Field of Search: 604/101.01, 604/53, 604/104, 604/102, 604/96, 604/19, 604/22, 604/27, 604/43, 604/35, 604/49, 604/101.03, 126/4, 606/49, 606/192
• US Class Current: 604/101.01
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The present invention pertains to a local delivery device comprising a distal catheter unit and a proximal catheter unit which may be positioned by sliding over the distal catheter unit. Both the distal and the proximal catheter units have separate inflatable occluding balloons. The slidable positioning of the catheter units in relation to each other provides for variable inter-balloon distances, which in turn provides for a variably sized occlusion region in a hollow tubular organ, for example a vessel. Dispersed on the catheter shaft between the two occluding balloons are multiple infusion ports through which therapeutic agents may be delivered to an occluded region of a hollow tubular organ. The local delivery device may further comprise a quantifying device for determining the distance between the two occluding balloons. Therefore, precise adjustment of the inter-balloon distance permits controlled delivery of therapeutics to a discreet length of the hollow tubular organ wall.

Claims

1. A local delivery device for the administration of a liquid of interest comprising:

i) a distal catheter unit comprising a distal occluding balloon in communication with a distal occluding balloon inflation port, a distal catheter shaft comprising a plurality of infusion ports distributed within said distal catheter shaft and in fluid communication with a liquid of interest delivery port;

ii) a proximal catheter unit, comprising a proximal occluding balloon in communication with a proximal occluding balloon inflation port, and a proximal catheter shaft, said distal catheter shaft slidable within said proximal catheter shaft; and

iii) an adjustment mechanism for setting a distance between said distal occluding balloon and said proximal occluding balloon.

2. The local delivery device of claim 1 wherein a valve element is associated with said adjustment mechanism, said valve element comprising an “

O”

ring hemostatic valve.

3. The local delivery device of claim 1, wherein said adjustment mechanism is selected from the group consisting of a threaded screw adjustment mechanism, a rack and pinion, a toothed displacement mechanism, a hydraulic regulated displacement mechanism, a compressed air regulated displacement mechanism, a frictional slide adjustment mechanism, a motor drive, and an automatic pull back, said adjustment mechanism interacting with either said distal catheter shaft, said proximal catheter shaft, or both said distal and proximal catheter shafts.

4. The local delivery device of claim 1, further comprising a quantifying device for determining said distance.

5. The local delivery device of claim 1, wherein said distal catheter unit further comprises a lumen traversing the terminal portion of said distal catheter shaft, said lumen capable of receiving a guidewire.

6. The local delivery device of claim 1, wherein said distal catheter unit further comprises a lumen traversing the entire length of said distal catheter shaft, said lumen capable of receiving a guidewire.

7. The local delivery device of claim 1, wherein said proximal catheter shaft comprises within its inner surface a sealing element, said sealing element capable of forming a seal between said proximal catheter shaft and said distal catheter shaft thereby sealing a lumen formed between said proximal and distal catheter shafts and stopping any flow of the liquid of interest past said sealing element.

8. The local delivery device of claim 1, further comprising a perfusion lumen.

9. The local delivery device of claim 1, further comprising a balloon catheter between said distal and proximal balloon catheters.

10. The local delivery device of claim 1, further comprising one or more balloon catheters outside the region between said distal and proximal balloon catheters.

15. The local delivery device of claim 1, further comprising a valve element associated with said adjustment mechanism, said valve element having an open position and a closed position, whereby movement of said valve element into said open position permits said adjustment mechanism to set said distance, and movement of said valve element into said closed position fixes said distance.

16. The local delivery device of claim 15, wherein the valve element comprises an “

O”

ring hemostatic valve.

17. The local delivery device of claim 15, wherein said adjustment mechanism is selected from the group consisting of a threaded screw adjustment mechanism, a rack and pinion, a toothed displacement mechanism, a hydraulic regulated displacement mechanism, a compressed air regulated displacement mechanism, a frictional slide adjustment mechanism, a motor drive, and an automatic pull back, said adjustment mechanism interacting with either said distal catheter shaft, said proximal catheter shaft, or both said distal and proximal shafts.

18. The local delivery device of claim 15, further comprising a quantifying device for determining said distance.

19. The local delivery device of claim 15, wherein said distal catheter unit further comprises a lumen traversing the terminal portion of said distal catheter shaft, said lumen capable of receiving a guidewire.

20. The local delivery device of claim 15, wherein said distal catheter unit further comprises a lumen traversing the entire length of said distal catheter shaft, said lumen capable of receiving a guidewire.

21. The local delivery device of claim 15, wherein said proximal catheter shaft comprises within its inner surface a sealing element, said sealing element capable of forming a seal between said proximal catheter shaft and said distal catheter shaft thereby sealing a lumen formed between said proximal and distal catheter shafts and stopping any flow of the liquid of interest past said sealing element.

22. The local delivery device of claim 15, further comprising a perfusion lumen.

23. The local delivery device of claim 15, further comprising a balloon catheter between said distal and proximal balloon catheters.

24. The local delivery device of claim 15, further comprising one or more balloon catheters outside the region between said distal and proximal balloon catheters.

11. A local delivery device comprising:

i) a distal catheter unit comprising a distal occluding balloon in communication with a distal occluding balloon inflation port, and

ii) a proximal catheter unit, comprising a medical device selected from the group consisting of a laser, a fibre optic, and an ultrasound device, wherein said distal catheter shaft is slidable within said proximal catheter shaft; and

iii) an adjustment mechanism for setting a distance between said distal occluding balloon and a terminal portion of said proximal catheter unit, said adjustment mechanism interacting with either said distal catheter shaft, said proximal catheter shaft, or both said distal and proximal catheter shafts, said adjustment mechanism when actuated causes said proximal catheter shaft or said distal catheter shaft to move relative to each other.

12. The local delivery device of claim 11, wherein said distal catheter shaft further comprises a plurality of infusion ports distributed within said distal catheter shaft and in fluid communication with a therapeutic agent delivery port.

13. The local delivery device of claim 11, further comprising a quantifying device for determining said distance.

14. The local delivery device of claim 11, further comprising an optical fibre.

25. The local delivery device of claim 11, further comprising, a valve element associated with said adjustment mechanism, said valve element having an open position and a closed position, whereby movement of said valve element into said open position permits said adjustment mechanism to set said distance, and movement of said valve element into said closed position fixes said distance.

26. The local delivery device of claim 25, wherein said distal catheter shaft further comprises a plurality of infusion ports distributed within said distal catheter shaft and in fluid communication with a therapeutic agent delivery port.

27. The local delivery device of claim 25, further comprising a quantifying device for determining said distance.