POSITIONING DEVICE FOR OSTIAL LESIONS

• US 20110190708A1
• Filed: 02/25/2011
• Published: 08/04/2011
• Est. Priority Date: 03/04/2004
• Status: Active Grant

• Current Assignee: YMED Incorporated
• Original Assignee: YMED Incorporated
• Inventors: Shaked, Yoav, Solar, Ronald J.
• Granted Patent: US 9,050,437 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61M 2025/0186 Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for positioning a catheter at an ostium. The device includes an attachment mechanism for direct attachment to the catheter at a location proximal to a treatment device positioned on the catheter, the attachment mechanism having a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end. The device also including a stopper element extending from the distal end of the attachment mechanism and projecting away from the longitudinal axis, the stopper element being bendable in a direction toward the proximal end of the attachment mechanism.

Claims

1. A device for positioning a catheter at an ostium, the device comprising:

an attachment mechanism for direct attachment to the catheter at a location proximal to a treatment device positioned on the catheter, the attachment mechanism having a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end; and

a stopper element extending from the distal end of the attachment mechanism and projecting away from the longitudinal axis, the stopper element being bendable in a direction toward the proximal end of the attachment mechanism.

2. The device according to claim 1, wherein the stopper element comprises a spring wire with a proximal end and a distal end, wherein the attachment mechanism comprises a jacket that at least partially encloses the proximal end of the stopper element, and wherein the distal end of the stopper element is unenclosed by the attachment mechanism.

3. The device according to claim 1, wherein the stopper element is immovable with respect to the attachment mechanism along the longitudinal axis thereof.

4. The device according to claim 1, wherein the attachment mechanism comprises a first diameter prior to attachment to the catheter, and a second diameter smaller than the first diameter upon attachment to the catheter, and wherein the attachment mechanism is attached to the catheter by changing the first diameter to the second diameter.

5. The device according to claim 4, wherein the attachment mechanism is integral to the stopper element such that the attachment mechanism creates an anchoring portion of the device, and the stopper element creates an expandable portion of the device.

6. The device according to claim 4, wherein the attachment mechanism comprises a coil.

7. The device according to claim 4, wherein the attachment mechanism comprises a double helix.

8. The device according to claim 4, wherein the attachment mechanism comprises a stent-like configuration.

9. The device according to claim 4, wherein the attachment mechanism comprises a braid.

10. The device according to claim 4, wherein the attachment mechanism comprises a tube.

11. The device according to claim 1, wherein the stopper element projects toward the proximal end of the attachment mechanism in a delivery configuration, and projects outwardly with respect to the longitudinal axis in a deployed configuration.

12. The device according to claim 1, wherein the attachment mechanism is urged to a smaller diameter when a force is applied to the proximal end.

13. The device according to claim 1, wherein the attachment mechanism comprises a wire mesh.

14. The device according to claim 1, further comprising multiple stopper elements.

15. The device according to claim 14, wherein at least two of the multiple stopper elements are connected by a connecting element.

16. A method for positioning a catheter in the ostium of a vessel branching off from a main vessel, the method comprising:

providing a device having an attachment mechanism and a stopper element, the attachment mechanism for attachment to a catheter shaft, and the stopper element located at a distal end of the attachment mechanism and projecting away from the longitudinal axis of the attachment mechanism;

providing a catheter having a shaft along its length and a treatment device at a distal end thereof;

attaching the attachment mechanism to the shaft of the catheter such that the stopper element is positioned proximal of the treatment device;

positioning a guiding catheter in a vessel to a location proximal of the ostium;

placing a guidewire through the guiding catheter and into the ostium;

advancing the catheter with the device attached thereto over the guidewire and through the guiding catheter, wherein the stopper element is folded back proximally within the guiding catheter;

advancing the catheter with the device attached thereto past a distal end of the guiding catheter, causing the stopper element to be released from the guiding catheter and to project outwardly with respect to the longitudinal axis of the attachment mechanism;

pushing the catheter into the ostial vessel until the stopper element pushes against a wall of the main vessel at the ostium, preventing further advancement of the catheter;

deploying the treatment device once the catheter is in position in the ostial vessel; and

pulling the catheter and the attached treatment device proximally through the guiding catheter.

17. The method according to claim 16, wherein the catheter further includes a balloon and a stent, and wherein deploying the treatment device comprises expanding the balloon to expand the stent.

18. The method according to claim 16, wherein the attaching is performed by placing the catheter in a mounting unit having measurement units and further placing the device into the mounting unit and over the catheter at a location determined by the measurement units.

19. The method according to claim 16, wherein the attaching is performed by placing the device over a shaft of the catheter, and by minimizing a diameter of the device.

20. The method according to claim 19, wherein the attaching is further performed by placing a sticky coating on the anchoring portion of the device.