Improved vascular incisor/dilator

• US 5,649,941 A
• Filed: 12/20/1995
• Issued: 07/22/1997
• Est. Priority Date: 01/10/1995
• Status: Expired due to Term

• Current Assignee: Banning G. Lary
• Original Assignee: Interventional Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Lary, Banning Gray
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/576,194
• Time in Patent Office: 580 Days
• Field of Search: 606/1, 606/159, 606/170, 606/171, 606/180, 606/191, 604/22, 604/96, 128/898
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00566 fixation of form upon application of vacuum
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A device and method for clearing a stenosis in a vessel of a patient requires a catheter having a rigid, cone-shaped probe at its distal end. The probe has a distally diminishing taper and also has a plurality of blades which are mounted on the probe and longitudinally aligned with the catheter. The probe is formed to include a series of grooves which span the length of the probe. Advancement of the probe through the vessel to the stenosis can be accomplished either over a prepositioned guidewire or through a prepositioned guide catheter. At the stenosis, the probe with mounted blades are reciprocally moved back and forth across the stenosis to incise and dilate the stenosis and, thus, clear the stenosis. Blood flow is maintained within the vessel by the grooves formed in the surface of the probe. Movement of the probe across the stenosis can be facilitated by selectively activating a rigidizer which is located on the catheter immediately proximal to the probe. Additionally, a balloon can be mounted on the catheter proximal the dilation probe and selectively inflated at the stenosis after the stenosis has been incised and dilated.

Claims

1. A device for clearing a stenosis in a vessel of a patient without compromising fluid flow in said vessel, said device comprising:

a catheter having a distal end;

a rigid dilation probe, said dilation probe having a proximal end attached to said distal end of said catheter, said dilation probe also having a tapered distal end, said dilation probe formed with a plurality of grooves, each said groove extending between said distal end of said dilation probe and said proximal end of said dilation probe; and

a plurality of blades attached to project radially from said dilation probe.

2. A device as recited in claim 1 further comprising guide means for advancing said dilation probe through said vessel to said stenosis.

3. A device as recited in claim 2 wherein said guide means is a guidewire, said guidewire having a distal end prepositionable in the vessel, said guidewire also having a proximal end insertable through a contiguous lumen formed in said dilation probe, said dilation probe advancable over said guidewire to guide said dilation probe to said stenosis.

4. A device as recited in claim 2 wherein said guide means is a guide catheter, said guide catheter being prepositionable in said vessel, said guide catheter formed with a lumen for receiving said dilation probe and said catheter to guide said dilation probe to the stenosis.

5. A device as recited in claim 2 wherein said dilation probe is substantially conical in shape.

6. A device as recited in claim 2 wherein said dilation probe is substantially ellipsoidal in shape.

7. A device as recited in claim 2 wherein said dilation probe and said catheter define a longitudinal axis and wherein said blades are aligned to substantially parallel said longitudinal axis.

8. A device as recited in claim 2 further comprising a selectively inflatable balloon mounted on said catheter proximal to said dilation probe.

9. A device as recited in claim 2 further comprising means for rigidizing a portion of said catheter to facilitate movement of said dilation probe through the stenosis.

10. A device for clearing a stenosis in a vessel of a patient without compromising fluid flow in said vessel, said device comprising:

a dilation probe for dilating said stenosis, said dilation probe having a distal end and a proximal end and being formed with a plurality of fluid channels for establishing fluid communication between said distal end and said proximal end thereof;

a plurality of blades attached to said dilation probe, said blades projecting radially from said dilation probe for incising said stenosis;

means for advancing said dilation probe through said vessel to said stenosis; and

a catheter having a distal end, said distal end of said catheter being fixedly attached to said dilation probe for moving said dilation probe through said vessel and said stenosis for dilating and incising said stenosis.

11. A device as recited in claim 10 wherein said catheter and said dilation probe are formed with a contiguous lumen and said means for advancing is a guidewire, said guidewire being prepositionable in the vessel and insertable through said lumen to guide said dilation probe to the stenosis.

12. A device as recited in claim 10 wherein said means for advancing is a guide catheter, said guide catheter being prepositionable in the vessel and formed with a lumen for receiving said dilation probe and said catheter therethrough to advance said dilation probe to the stenosis.

13. A device as recited in claim 10 wherein said dilation probe is substantially cone-shaped with a tapered portion having a diminishing cross sectional area in the distal direction, and wherein said catheter defines a longitudinal axis and said blades are aligned longitudinally on said dilation probe.

14. A device as recited in claim 10 further comprising a selectively inflatable balloon mounted on said catheter proximal to said dilation probe.

15. A device as recited in claim 10 further comprising means for rigidizing a portion of said catheter proximal to said dilation probe.

16. A method for clearing a stenosis in a vessel of a patient without compromising fluid flow in said vessel which comprises the steps of:

advancing a device to the stenosis through the vessel, said device comprising a catheter having a distal end, a rigid dilation probe, said dilation probe having a proximal end attached to said distal end of said catheter, said dilation probe also having a tapered distal end, said dilation probe formed with a plurality of grooves, each said groove extending between said distal end of said dilation probe and said proximal end of said dilation probe, a plurality of blades attached to project radially from said dilation probe; and

moving said dilation probe of said device in the vessel and through the stenosis to incise and dilate the stenosis.

17. A method as recited in claim 16 wherein said catheter and said dilation probe are formed with a contiguous lumen and wherein said advancing step is accomplished by the steps of:

prepositioning a guidewire in the vessel and through the stenosis; and

inserting said guidewire into said lumen; and

advancing said dilation probe and said catheter over said guidewire and into contact with the stenosis.

18. A method as recited in claim 16 further comprising the steps of:

prepositioning a guide catheter in the vessel, said guide catheter being formed with a lumen for receiving said dilation probe and said catheter therethrough to guide said dilation probe to the stenosis; and

Advancing said dilation probe and said catheter through said lumen of said guide catheter and into contact with the stenosis.

19. A method as recited in claim 16 wherein said device further comprises a selectively inflatable balloon mounted on said catheter proximal to said dilation probe, and said method further comprises the step of selectively inflating said balloon against the stenosis after the dilation probe has dilated and incised the stenosis.

20. A method as recited in claim 16 wherein said device further comprises means for rigidizing a portion of said catheter proximal to said dilation probe to facilitate movement of said dilation probe through the stenosis.