Universal dilator with expandable incisor

• US 5,697,944 A
• Filed: 11/15/1995
• Issued: 12/16/1997
• Est. Priority Date: 11/15/1995
• 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): LEWIS, WILLIAM W
• Application Number:
  US08/559,415
• Time in Patent Office: 762 Days
• Field of Search: 606/1, 606/108, 606/159, 606/167, 606/170, 606/171, 606/180, 604/96, 128/898, 128/899
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A device for incising and dilating a stenosis in a vessel of a patient includes a dilator housing and a plurality of blades which can be selectively extended from the housing. Specifically, the housing is formed to surround a chamber and the chamber contains an inflatable balloon. The plurality of blades are mounted on the inflatable balloon and pass through slits in the housing. The housing is attached to a placement catheter which includes a lumen for inflating and deflating the balloon. In the operation of the device, the balloon is selectively inflated within the chamber to move the device between a retracted and an expanded configuration. In the retracted configuration, the balloon is deflated and the blades are withdrawn into the housing and the housing is used as a dilator. In the expanded configuration, the balloon is inflated and the blades are extended through the slits in the housing and the device is used as an incisor.

Claims

1. A device for incising and dilating a stenosis in a vessel which comprises:

an inflatable balloon;

a plurality of blades mounted onto said balloon;

a housing made of a rigid plastic and formed with a plurality of slits and surrounding a chamber therein, said balloon being positioned in said chamber with each said blade aligned with a respective said slit;

a placement catheter, said placement catheter being formed with a lumen and having a distal end, said distal end of said placement catheter being attached to said housing for positioning of said housing in said vessel; and

a fluid pressure source attached in fluid communication with said balloon for inflation of said balloon in said chamber between a first position wherein said blades are withdrawn into said housing for use of said device as a dilator and a second position wherein said blades extend through said slits of said housing for use of said device as an incisor.

2. A device as recited in claim 1 wherein said housing is substantially ellipsoidal in shape.

3. A device as recited in claim 1 wherein said device further comprises a guidewire insertable through said lumen, said guidewire being prepositionable in a vessel of a patient for advancing said device to a stenosis in the vessel.

4. A device as recited in claim 1 wherein said blades are made of a metal.

5. A device as recited in claim 1 wherein said placement catheter is made of PET.

6. A device for incising and dilating a stenosis in a vessel which comprises:

an inflatable balloon;

a plurality of blades mounted on said balloon;

a housing made of a rigid plastic for dilating said stenosis in said vessel, said housing shaped to surround said balloon;

means attached to said housing for positioning said housing within said vessel; and

means attached to said balloon for inflation of said balloon between a first position wherein said blades are withdrawn into said dilating means for use of said device as a dilator and a second position wherein said blades extend from said dilating means for use of said device as an incisor.

7. A device as recited in claim 6 wherein said blades are made of a metal.

8. A device as recited in claim 6 wherein said housing is formed with a plurality of slits to surround a chamber therein, said balloon being positioned in said chamber with said blades aligned with said slits.

9. A device as recited in claim 6 wherein said housing is substantially ellipsoidal in shape.

10. A device as recited in claim 6 wherein said positioning means comprises a placement catheter, said placement catheter being formed with a lumen and having a distal end, said distal end of said placement catheter being attached to said housing for positioning of said housing in said vessel.

11. A device as recited in claim 10 wherein said placement catheter is made of PET.

12. A device as recited in claim 10 wherein said device further comprises a guidewire insertable through said lumen, said guidewire being prepositionable in a vessel of a patient for advancing said device to a stenosis in the vessel.

13. A method for incising and dilating a stenosis in a vessel of a patient which comprises the steps of:

advancing a device to the stenosis through the vessel, said device comprising an inflatable balloon, a plurality of blades mounted to said balloon, a housing formed with a plurality of slits to surround a chamber therein, said balloon being positioned in said chamber with said blades aligned with said slits, a catheter attached to said housing for positioning of said housing in said vessel, said catheter attached in fluid communication with said balloon for inflation of said balloon in said chamber between a first position wherein said blades are withdrawn into said housing and a second position wherein said blades extend through said slits of said housing;

selectively inflating said balloon to extend said blades through said slits of said housing to incise said stenosis;

selectively deflating said balloon to withdraw said blades into said housing; and

moving said housing of said device in the vessel and through the stenosis to dilate the stenosis.

14. A method as recited in claim 13 wherein said balloon and said catheter 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 device over said guidewire and into contact with the stenosis.

15. A method as recited in claim 13 further comprising the steps of:

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

advancing said housing and said catheter through said lumen of said guide catheter and into contact with the stenosis.