Balloon catheter with controller depth incising blade

• US 7,736,375 B2
• Filed: 11/29/2004
• Issued: 06/15/2010
• Est. Priority Date: 11/29/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Crow, Loren M.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US10/998,455
• Publication Number:
  US 20060116701A1
• Time in Patent Office: 2,024 Days
• Field of Search: 606/159, 606/167, 606/170, 606192-194, 606/172, 604/22, 604/96.01, 303/05, 711/8, 711/9
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart

Abstract

A device for incising tissue to a pre-selected incision depth within a body conduit of a patient includes an elongated balloon catheter and at least one elongated straight blade that is mounted on the balloon. To control the incision depth, each blade has a blunt section formed with a non-incising surface and a cutting edge positioned distally to the blunt section. A proximal portion of the blade is attached to a proximal balloon section, and in operation, the balloon/blade combination is advanced into the body conduit and positioned distal to the target tissue/stenosis. The balloon is then inflated. With this inflation, the blade is inclined relative to the axis of the catheter with an increasing distance between the blade and the axis in a distal direction. The device is then withdrawn, proximally, to incise the tissue/stenosis.

Claims

1. A device for incising tissue to a pre-selected incision depth within a body conduit of a patient, the device comprising:

a catheter;

an elongated balloon defining an axis, the balloon being mounted on the catheter for reconfiguration between an inflated configuration and a deflated configuration; and

a substantially straight elongated blade having a distal end and a proximal end and defining a blade axis, with the proximal end thereof attached to the balloon to orient the blade in a plane with the axis of the balloon and to project a sharp edge at the distal end of the blade in a radial direction from the axis of the balloon when the balloon is inflated, the blade having a blunt section positioned proximal to the sharp edge to limit the incision of tissue by the sharp edge of the blade to the pre-selected incision depth during a proximal movement of the balloon in its inflated configuration.

2. A device as recited in claim 1 further comprising a guidewire for advancing the catheter through the body conduit to position the balloon for cutting tissue at a predetermined site in the body conduit.

3. A device as recited in claim 1 wherein the balloon has a proximal end and a distal end and, in its inflated configuration, the balloon further comprises:

a substantially conical-shaped proximal section having a taper with increasing radius in the distal direction;

a substantially conical-shaped distal section having a taper with decreasing radius in the distal direction;

a substantially cylindrical-shaped intermediate section located between the proximal section and the distal section; and

wherein the blade is attached to the proximal section of the balloon with the proximal end of the blade adjacent the proximal end of the balloon.

4. A device as recited in claim 1 wherein the blunt section is formed with a rounded surface portion.

5. A device as recited in claim 1 wherein the blunt section comprises a protective sheath overlaying a sharp blade edge.

6. A device as recited in claim 1 wherein the blunt section is formed with a substantially spherical surface.

7. A device for incising to a pre-selected incision depth within a body conduit of a patient, the device comprising:

a substantially straight elongated blade defining a blade axis and having a blunt section and a cutting edge section, the blunt section formed with a non-incising surface, with the blunt section positioned proximally from the cutting edge section to limit incision to the cutting edge section of the blade;

a means for advancing the elongated blade in a distal direction along a predetermined path in the body conduit;

a means for inclining the blade relative to the path with an increasing distance between the blade and the path in the distal direction; and

a means for withdrawing the blade in a proximal direction along the path.

8. A device as recited in claim 7 wherein the advancing means is a catheter and the inclining means is a balloon.

9. A device as recited in claim 8 wherein the balloon has a proximal end and a distal end and, when inflated, the balloon further comprises:

a substantially conical-shaped proximal section having a taper with increasing radius in the distal direction;

a substantially conical-shaped distal section having a taper with decreasing radius in the distal direction; and

a substantially cylindrical-shaped intermediate section located between the proximal section and the distal section.

10. A device as recited in claim 9 wherein the blade is attached to the proximal section of the balloon with the proximal end of the blade adjacent the proximal end of the balloon.

11. A device as recited in claim 7 wherein the blunt section is formed with a rounded surface portion.

12. A device as recited in claim 7 wherein the blunt section comprises a protective sheath overlaying a sharp blade edge.

13. A device as recited in claim 12 wherein the protective sheath is made of plastic.

14. A device as recited in claim 12 wherein the protective sheath is tubular shaped.

15. A device as recited in claim 7 wherein the blunt section is formed with a substantially spherical surface.

16. A device as recited in claim 15 wherein the blade has a maximum dimension, d, normal to the blade axis and the substantially spherical surface has a radius, r, with d<

2 r.

17. A method for incising tissue to a pre-selected incision depth at an incision location within a body conduit of a patient, the method comprising the steps of:

providing a substantially straight elongated blade defining a blade axis and having a blunt section and a cutting edge section, the blunt section formed with a non-incising surface, with the blunt section positioned proximally from the cutting edge section to limit incision to the cuffing edge section of the blade;

advancing the elongated blade in a distal direction along a predetermined path into the body conduit of a patient, to position the blade distal to the incision location;

inclining the blade relative to the path with an increasing distance between the blade and the path in the distal direction; and

withdrawing the blade in a proximal direction along the path to incise at the pre-selected incision depth.

18. A method as recited in claim 17 wherein the non-incising surface comprises a rounded surface portion.

19. A method as recited in claim 17 wherein the blunt section comprises protective sheath overlaying a sharp blade edge.