Incisor-dilator with tapered balloon

• US 6,258,108 B1
• Filed: 10/17/1997
• Issued: 07/10/2001
• Est. Priority Date: 09/13/1996
• Status: Expired due to Fees

• Current Assignee: Lary Research & Development LLC
• Original Assignee: Interventional Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Lary, Banning Gray
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/953,224
• Time in Patent Office: 1,362 Days
• Field of Search: 606/159, 606/194, 606/170
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present invention is a device for incision and dilation of stenotic segments within the vascular system of a patient. Structurally, the present invention includes a rigid ellipsoidal dilation probe mounted at the distal end of a catheter. A series of longitudinally oriented blades project radially from the surface of the probe. A tapered inflatable balloon is also mounted on the catheter in a position that is proximal to the dilation probe. In use, the probe and catheter are advanced over a guidewire to reach the targeted stenotic segment. The probe and blades are then advanced through the stenotic segment to incise the stenosis. The balloon may then be inflated to adopt a tapering fusiform shape, allowing the balloon to be advanced through the stenosis to further dilate the stenosis. Alternatively, the balloon may be positioned across the stenosis and inflated to dilate the stenosis. The fusiform shape of the balloon matches the tapering geometry of many coronary arterial vessels, decreasing the chances that a segment of the vessel will be overpressurized by the inflating balloon.

Claims

1. A device for incising and dilating stenotic tissue within a lumen of a vessel, the device comprising:

a catheter having a distal end;

a probe mounted on the catheter proximate the distal end, the probe having a distal portion which includes a tapered section having a proximally increasing cross-section;

at least three blades moveable between a first configuration where the blades are retracted into the probe and a second configuration where the blades extend along the tapered section of the probe for incising the stenotic tissue and wherein a distal end of at least one of the blades is pivotably attached to the probe; and

an inflatable balloon for dilating the stenotic tissue, the balloon being mounted proximally to the probe.

2. The device of claim 1 wherein the balloon has a distal end, a proximal end, and a surface with an apogee thereon between the distal end and the proximal end of the balloon, and the surface of the balloon between the distal end of the balloon and the apogee is tapered with a proximally increasing radius when the balloon is inflated.

3. A device as recited in claim 1 wherein the blades are spaced apart and extend substantially radially from the tapered section of the probe.

4. A device as recited in claim 1 including four spaced apart blades positioned substantially radially around the probe.

5. A device as recited in claim 1 wherein the probe is formed to surround a chamber and wherein the blades are positioned within the chamber in the first configuration.

6. The device of claim 1 including a wedge shaped piston which moves relative to the catheter and facilitates movement of at least one blade between the first configuration and the second configuration.

7. The device of claim 1 wherein the probe has an apogee with a larger diameter than an outer diameter of the catheter.

8. A device as recited in claim 1 including a spring carrier securing a distal end of one of the blades to the catheter.

9. A device for incising and dilating stenotic tissue within a lumen of a vessel, the device comprising:

a catheter;

a probe secured to the catheter, the probe having a distal portion, the distal portion including a tapered section having a proximally increasing cross-section; and

a blade including a distal end which is pivotably attached to the probe and extends through the tapered section of the probe for incising the stenotic tissue.

10. The device of claim 9 including at least three blades which extend substantially radially from the probe, the blades being movable between a first configuration where the blades are retracted into the probe and a second configuration where the blades extend from the probe.

11. The device of claim 9 including an inflatable balloon secured to the catheter for selectively dilating the stenotic tissue.

12. The device of claim 11 wherein the balloon includes a distal end, a proximal end and a surface with an apogee thereon between the distal end and the proximal end of the balloon, and the surface of the balloon between the distal end of the balloon and the apogee is tapered with a proximally increasing radius when the balloon is inflated.

13. The device of claim 9 including a spring carrier securing the distal end of the blade to the catheter.

14. The device of claim 9 including a wedge shape piston which moves relative to the catheter and facilitates pivoting of the blade.

15. The device of claim 9 further comprising a motor for selectively and alternately moving the blade between a first configuration wherein the blade is retracted into the probe and a second configuration wherein the blade extends from the probe.

16. The device of claim 9 wherein the probe has an apogee with a larger diameter than an outer diameter of the catheter.

17. A method for incising, and dilating a stenotic tissue within a lumen of a vessel, the method comprising the steps of:

providing a device which includes (i) a catheter having a distal end, (ii) a substantially rigid probe having a distal portion which includes a tapered section having a proximally increasing cross-section, (iii) at least three blades being adapted for selectively extending from the tapered section, the blades being moveable between a first configuration where the blades are retracted into the probe and a second configuration where the blades extend along the tapered section of the probe for incising the stenotic tissue and wherein a distal end of at least one of the blades ls pivotably attached to the probe, and (iv) an inflatable balloon for dilating the stenotic tissue, the balloon being mounted on the catheter proximally to the probe;

advancing the device through the vessel to position the distal end of the device proximate the stenotic tissue;

extending the at least three blades at least partly from the probe from the first configuration toward the second configuration;

advancing the probe through the stenotic tissue to incise the stenotic tissue; and

inflating the balloon to dilate the stenotic tissue.

18. A method as recited in claim 17 further comprising the steps of:

providing a guidewire;

positioning the guidewire in the vessel; and

advancing the device over the guidewire.