Focalized stent implantation

• US 6,872,215 B2
• Filed: 06/24/2002
• Issued: 03/29/2005
• Est. Priority Date: 02/24/1994
• Status: Expired due to Fees

• Current Assignee: Adiance Medical Systems Incorporated
• Original Assignee: Adiance Medical Systems Incorporated
• Inventors: Crocker, Michael, Shimada, Lynn M.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/179,468
• Publication Number:
  US 20030028211A1
• Time in Patent Office: 1,009 Days
• Field of Search: 606/192, 606/194, 606/108, 604/96.01, 604/101.01, 604/101.02, 604/101.03
• US Class Current: 606/192
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed is a focal balloon having at least one reference zone and a focal zone. In one embodiment, the reference zone and focal zone are inflatable to a first generally cylindrical profile at a first pressure. At a second, greater pressure, the focal section expands to a second, greater diameter, while the reference zone remains substantially at the first diameter. In an alternate embodiment, the focal zone and the reference zone are inflatable to their respective predetermined diameters at the inflation pressure, in the absence of constricting lesions or anatomical structures. Multiple lobed and drug delivery embodiments are also disclosed.

Claims

1. A method of sizing a stent within a body lumen, comprising:

locating a stent positioned within a body lumen;

providing a catheter comprising an elongate tubular body with an expandable balloon on a distal end thereof, said balloon comprising a proximal zone, a distal zone, and a central zone disposed therebetween;

positioning the catheter such that at least the central zone is within the stent;

expanding the balloon such that the central zone exerts a greater outward radial force upon the stent than either of the proximal and distal zones, thereby sizing the stent, contracting the balloon; and

withdrawing the catheter from the body lumen.

2. A method according to claim 1, wherein the central zone of the balloon is expanded to a diameter about 0.1 mm to 1.0 mm greater than the diameter of the proximal and distal zones.

3. A method according to claim 2, wherein the proximal and distal zones of the balloon are expanded to a diameter between about 1.5 mm and about 4.0 mm.

4. A method according to claim 1 further comprising delivering a drug together with sizing the stent.

5. A method according to claim 4, wherein delivering a drug comprises expressing a fluid comprising a drug through pores on the outer surface of the expandable balloon.

6. A method of implanting a tubular stent within a body lumen, comprising:

locating a treatment site with a body lumen;

providing a catheter comprising an elongate tubular body with an expandable balloon on a distal end thereof, said balloon comprising a proximal zone, a distal zone, a central zone extending between the proximal and distal zones, and a stent positioned on at least the central zone;

positioning the catheter such that the central zone is at the treatment site;

expanding the balloon such that the portion of the stent positioned on the central zone expands to a greater diameter than the portion of the stent positioned on the proximal or distal zones, thereby implanting the stent;

contracting the balloon; and

withdrawing the catheter from the body lumen.

7. A method according to claim 6, wherein the central zone of the balloon is expanded to a diameter about 0.1 mm to 1.0 mm greater than the diameter of the proximal and distal zones.

8. A method according to claim 6, wherein the proximal and distal zones of the balloon are expanded to a diameter between about 1.5 mm and about 4.0 mm.

9. A method according to claim 6 further comprising delivering a drug together with implanting the stent.

10. A method according to claim 9, wherein delivering a drug comprises expressing a fluid comprising a drug through pores on the outer surface of the expandable balloon.

11. A method of implanting a tubular stent within a body lumen, comprising:

locating a site with a body lumen;

providing a stent delivery catheter having a stent, including a center portion and two end portions, positioned on a distal portion of the stent delivery catheter;

positioning the catheter such that at least the center portion of the stent is at the site;

expanding the stent such that the center portion of the stent is expanded to a greater diameter than the end portions of the stent, thereby implanting the stent; and

withdrawing the catheter from the body lumen.

12. A method according to claim 11 further comprising delivering a drug upon implanting the stent.

13. A method according to claim 12, wherein delivering a drug comprises expressing a fluid comprising a drug through pores on the distal portion of the stent delivery catheter.