Cerebral balloon angioplasty system

• US 4,921,478 A
• Filed: 02/23/1988
• Issued: 05/01/1990
• Est. Priority Date: 02/23/1988
• Status: Expired due to Fees

• Current Assignee: Myles L. Saunders
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Crittenden, James, Solano, Scott J., Saunders, Myles L.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/159,539
• Time in Patent Office: 798 Days
• Field of Search: 128/328, 128/344, 128/348.1, 604/53, 604/96-103, 604/256
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An occlusion catheter for use during the therapeutic intervention of a cerebral blood vessel for flushing away fluid and debris from the area of the therapeutic intervention is provided. The catheter carries an inflatable occlusion balloon capable of being formed into a funnel with the larger end of the funnel facing distally. The funnel-shaped occlusion balloon seals the walls of the vessel to establish retrograde flow of blood. The peripheral walls of the funnel meet the vessel walls at an oblique angle and channel fluid and debris flowing proximally into the funnel to efflux ports at the base of the funnel.

Claims

1. A blood vessel occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the area of the therapeutic intervention comprising,

an elongated shaft sized to be introduced into the blood vessel lumen,

occlusion means secured to the shaft at or near the distal end of the shaft, the occlusion means capable of forming a funnel with the larger end of the funnel facing distally on the shaft and contacting the vessel walls to form a seal against the vessel walls,

an inflation lumen carried by the shaft and communicating with the interior of the occlusion means enabling the occlusion means to be inflated into the shape of said funnel, wherein the occlusion means when inflated defines surfaces capable of channeling all fluid and debris contacting the surfaces continuously in a proximal direction to an efflux means,

efflux means enabling fluid and debris to be carried within the shaft toward and out of the proximal end of the shaft, and

intervention means located on the shaft distal to the inflatable means for treating a site along the blood vessel.

2. An occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the area of the therapeutic intervention comprising,

an elongated shaft sized to be introduced into the blood vessel lumen,

occlusion means secured to the shaft at or near the distal end of the shaft, the occlusion means capable of forming a funnel with the larger end of the funnel facing distally on the shaft and contacting the vessel walls to form a seal against the vessel walls, wherein said inflatable occlusion means comprises an elastic balloon secured to the shaft,

an inflation lumen carried by the shaft and communicating with the interior of the occlusion means enabling the occlusion means to be inflated into the shape of said funnel, wherein the occlusion means when inflated defines surfaces capable of channeling all fluid and debris contacting the surfaces continuously and at a proximal direction to an efflux means,

efflux means enabling fluid and debris to be carried within the shaft toward and out of the proximal end of the shaft, and

means located on the shaft and radially extending therefrom for engaging the balloon for causing the distal end of the balloon to form a funnel, the larger end of said funnel capable of forming a seal against the vessel walls.

3. A blood vessel occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the area of the therapeutic intervention comprising,

an elongated shaft sized to be introduced into the blood vessel lumen,

an elastic balloon secured to the shaft at or near its distal end,

an inflation lumen carried by the shaft and communicating with the interior of the balloon enabling the balloon to be inflated and for causing it to form a seal against the vessel proximally of the therapeutic intervention,

means attached to the shaft and radially extending therefrom for engaging the balloon for causing the distal end of the balloon to form a funnel with the larger end of the funnel facing distally on the shaft when the balloon is inflated,

and efflux means at the base of the funnel enabling fluid and debris which enter the funnel to be carried within the shaft toward and out of its proximal end.

4. An occlusion catheter as defined in claim 3 further comprising,

intervention means located on the shaft distal to the elastic balloon for treating a site along the blood vessel.

5. An occlusion catheter as defined in claim 3 wherein a second lumen is carried by the shaft, the second lumen having a sufficient diameter such that a dilitation catheter or other therapeutic device may be passed through the second lumen.

6. An occlusion catheter as defined in claim 3 wherein a second shaft extends through the first recited shaft and communicates with the efflux means to carrying the fluid and debris.

7. An occlusion catheter as defined in claim 6 wherein

the means engaging the balloon includes the first shaft, said second shaft being movable axially with respect to the first shaft to cause the first shaft to form the balloon into a funnel.

8. An occlusion catheter as defined in claim 7 wherein a second lumen is carried by the second shaft, the second lumen having a sufficient diameter such that a dilitation catheter or other therapeutic device may be passed through the second lumen.

9. An occlusion catheter as defined in claim 7 wherein the second shaft extends distally of the first shaft and further comprising,

intervention means carried on the second shaft distal of the elastic balloon for treating a site along the blood vessel.

10. An occlusion catheter as defined in claim 9 wherein the intervention means is a dilitation balloon secured to the second shaft and communicating with a second inflation lumen carried by the second shaft and enabling the dilitation balloon to be inflated at the site of the therapeutic intervention.

11. An occlusion catheter as defined in claim 6 wherein the two shafts form an annular lumen between them which comprises the inflation lumen.

31. A catheter system as defined in claim 7 wherein the inflatable means comprises a balloon and a balloon-forming element and, wherein the balloon-forming element comprises a cylindrical element secured to the shaft within the balloon and splayed its distal end to form the funnel facing in a distal direction when the balloon is inflated.

32. A catheter system as defined in claim 31 wherein the splayed end collapses against the surface of the shaft when the balloon is deflated and splays outwardly from the shaft when the balloon is inflated.

33. A catheter system as defined in claim 32 wherein the intervention means is a balloon dilitation catheter.

12. An occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the area of the therapeutic intervention comprising,

an elongated shaft sized to be introduced into the blood vessel lumen,

an elastic balloon secured to the shaft at or near its distal end,

an inflation lumen carried by the shaft and communicating with the interior of the balloon enabling the balloon to be inflated and for causing it to form a seal against the vessel proximally of the therapeutic intervention,

means engaging the balloon for causing the distal end of the balloon to form a funnel with the larger end of the funnel facing distally on the shaft when the balloon is inflated, said means engaging the balloon including a plurality of struts on the shaft extending in an axial direction with respect to the shaft,

additional means connected to the struts for moving the distal end and proximal ends of the struts toward one another and moving the intermediate portions of the struts radially outward to form the funnel in the distal end of the balloon, and

efflux means at the base of the funnel enabling fluid and debris which enter the funnel to be carried within the shaft to its proximal end.

13. An occlusion catheter as defined in claim 12 wherein

the additional means includes a second shaft extending in an axial direction in the first recited shaft and connected to one end of the struts.

14. An occlusion catheter as defined in claim 13 wherein

the second shaft is connected to the distal ends of the struts and is movable axially in the first recited shaft.

15. An occlusion catheter as defined in claim 14 wherein

the second shaft is coaxial with the first recited shaft and the distal end of the first recited shaft is connected to the second shaft,

and axially extending slits in the distal end of the first recited shaft closely adjacent the connection between the shafts define the struts within the balloon.

16. An occlusion catheter as defined in claim 15 wherein

the slit distal end of the first-recited shaft tapers in a distal direction to the surface of the second shaft.

17. An occlusion catheter as defined in claim 15 wherein a second lumen is carried by the second shaft, the second lumen having a sufficient diameter such that a dilitation catheter or other therapeutic device may be passed through the second lumen.

18. An occlusion catheter as defined in claim 17 wherein the second shaft extends distally of the first shaft and further comprising,

intervention means carried on the second shaft distal to the elastic balloon means for treating a site along the blood vessel.

19. An occlusion catheter as defined in claim 18 wherein the intervention means is a dilitation balloon secured to the second shaft and communicating with a second inflation lumen carried by the second shaft and enabling the dilitation balloon to be inflated at the site of the therapeutic intervention.

20. An occlusion catheter as defined in claim 15 wherein the two shafts form an annular lumen between them which comprises the inflation lumen.

21. An occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the area of the therapeutic intervention comprising,

an elongated shaft sized to be introduced into the blood vessel lumen,

an elastic balloon secured to the shaft at or near its distal end,

an inflation lumen carried by the shaft and communicating with the interior of the balloon enabling the balloon to be inflated and for causing it to form a seal against the vessel proximally of the therapeutic intervention,

means engaging the balloon for causing the distal end of the balloon to form a funnel with the larger end of the funnel facing distally on the shaft when the balloon is inflated, comprising a cylindrical element secured to the shaft and within the balloon and splayed at its distal end to form the funnel facing in a distal direction when the balloon is inflated and,

efflux means at the base of the funnel enabling fluid and debris which enter the funnel to be carried within the shaft to its proximal end.

22. An occlusion catheter as defined in claim wherein splayed end of the cylindrical element comprises a series of struts, said struts collapsing against the surface of the shaft when the balloon is deflated and splaying outwardly from the shaft when the balloon is inflated.

23. An occlusion catheter as defined in claim 22 further comprising,

intervention means carried on the shaft distal to the elastic balloon for treating a site along the blood vessel.

24. An occlusion catheter as defined in claim 23 wherein the intervention means is a dilitation balloon secured to the shaft and communicating with a second inflation lumen carried by the shaft and enabling the dilitation balloon to be inflated at the site of the therapeutic intervention.

25. An occlusion catheter as defined in claim 22 wherein a second lumen is carried by the shaft, the second lumen having a sufficient diameter such that a dilitation catheter may be passed through the second lumen.

26. An occlusion catheter for use during therapeutic intervention of a blood vessel for flushing away fluid and debris from the brain comprising,

a multi lumen elongated shaft sized to be introduced into the blood vessel lumen,

a forming element disposed over the distal end of the shaft and connected at its proximal end to the shaft, the distal end of the element being slit and splayed in a distal direction,

an elastic balloon secured at its proximal end to the shaft proximally of the splayed end of the element, and secured at its distal end to the shaft in a manner to encircle the splayed end of the element,

means connecting the interior of the balloon to one of the lumens of the shaft so that the balloon can be inflated and form a seal against the wall of the vessel lumen,

said splayed end of the element assuming a funnel shape with its larger end facing distally when the balloon is inflated and causing the balloon to conform to the shape of the funnel, and said element collapsing against the outer surface of the shaft when the balloon is deflated,

and means connecting the apex of the funnel with another of the lumens of the shaft so that the retrograde flow from the site of intervention will enter the funnel and be carried toward the proximal end of the shaft.

27. A catheter system for transluminal angioplasty of the cerebral vessels comprising,

an elongated multilumen shaft means sized to be introduced into the vessel lumen,

inflatable means secured to the shaft means near its distal end, the inflatable means capable of forming a funnel with the larger end of the funnel facing distally on the shaft means when inflated,

an inflation lumen passing axially through the shaft means and communicating with the interior of the inflatable means enabling the inflatable means to be inflated and causing it to form a funnel, the larger end of which forms an occluding seal against the vessel walls, efflux means at the base of the funnel communicating with an efflux lumen passing axially through the shaft means enabling fluid and debris which enter the funnel to be carried into the shaft toward its proximal end,

an intervention lumen extending axially through the shaft means,

and intervention means capable of being delivered through the intervention lumen to a site in the vessel distal to the inflatable means for therapeutically treating the site,

wherein the inflatable means comprises a balloon and a plurality of struts engaging the balloon, the struts extending in an axial direction with respect to a first shaft of the shaft means, and a second shaft of said shaft means extending axially and movable in the first shaft and connected to the distal ends of the struts for moving the distal and proximal ends of the struts closer to one another and moving the intermediate portions of the struts radially outward toward the wall of the vessel lumen to form the distal end of the balloon into a funnel shape.

28. A catheter system for transluminal angioplasty as claimed in claim 27 wherein the annular space between the shaft means defines the inflation lumen which communicates with the inside of the balloon through spaces between the struts.

29. A catheter system for transluminal angioplasty as claimed in claim 28 wherein the second shaft is tubular and the lumen of the second shaft defines the intervention lumen.

30. A catheter system as defined in claim 29 wherein the intervention means is a balloon dilitation catheter.

34. A method for therapeutic intervention at a site in a cerebral vessel comprising,

occluding the cerebral vessel at a location proximal and close to the intervention site to establish retrograde flow in said vessel distal of said occlusion,

therapeutically treating the intervention site,

collecting and withdrawing from the vessel fluid and debris moved to the occlusion by the retrograde flow, and

reestablishing antegrade flow of blood through the vessel.

35. A method for therapeutic intervention as defined in claim 34 wherein the cerebral vessel is occluded by forming a funnel shaped occlusion seal, the larger end of the funnel facing distally in the vessel and contacting the vessel to form the seal.

36. A method for therapeutic intervention as defined in claim 35 characterized by collecting the retrograde flowing fluid and debris in the funnel and allowing the fluid and debris to be flushed from the vessel through ports at the base of the funnel.

37. A method for therapeutic treatment as defined in claim 36 wherein the funnel shaped occlusion seal is formed by inflating an elastic balloon carried on the shaft.

38. A method for therapeutic treatment as defined in claim 37 wherein the shaft has a lumen and the intervention site is treated by introducing a balloon dilitation catheter distally through the lumen until the balloon lies across the treatment site and then inflating the balloon.

39. A method for therapeutic intervention at a site in a cerebral vessel comprising,

introducing an occluding means and a treatment means into a cerebral vessel, the occluding means carried on a shaft having efflux means capable of acting with the occluding means to collect and withdraw from the vessel fluid and debris distal of the occluding means,

activating the occluding means to seal the vessel at a location proximal of the intervention site and to establish retrograde flow in the vessel distal of the occluding seal,

therapeutically treating the intervention site with the treatment means,

collecting and withdrawing fluid and debris distal of the occluding seal through the efflux means, the retrograde flow moving debris toward the efflux means, and

deactivating the occlusion means to reestablish antegrade flow in the vessel.

40. A method for therapeutic intervention as defined in claim 39 wherein the occluding means is a balloon, an inflation lumen and balloon forming elements, all carried on the shaft, and further comprising the steps of inflating the balloon via the inflation lumen and causing the forming elements to act upon the balloon to form a funnel shaped occlusion seal, the larger end of the funnel facing distally and contacting the vessel to seal the vessel.

41. A method for therapeutic intervention as defined in claim 40 wherein the therapeutic treatment comprises inflating a dilitation balloon at the intervention site.

42. A method for therapeutic treatment as defined in claim 41 wherein the shaft has a second lumen and the treatment further comprises advancing a balloon dilitation catheter distally through the second lumen until the dilitation balloon lies across the treatment site.

43. A method for therapeutic intervention as defined in claim 41 wherein the treatment means is carried on the same shaft as the occlusion means and the shaft is introduced into the cerebral vessel and advanced until the treatment means is located at the treatment site.

44. A method for therapeutic treatment as defined in claim 43 wherein the occlusion means includes an occlusion balloon and the treatment means is a dilitation balloon, and wherein the occluding means is activated by inflating the occlusion balloon and causing it to form a distally facing funnel shaped seal and the treatment comprises inflating the dilitation balloon.

45. A method for therapeutic intervention as defined in claim 44 wherein the efflux means includes efflux ports located at the base of the funnel shaped occluding seal and further comprising collecting the fluid and debris flowing retrograde from the intervention site in the funnel and withdrawing the fluid and debris from the vessel through the efflux ports.