Hollow helical stent system

• US 7,942,917 B2
• Filed: 04/17/2009
• Issued: 05/17/2011
• Est. Priority Date: 04/17/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Nowak, Thomas Jr.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): Schubert; Christopher
• Application Number:
  US12/425,853
• Publication Number:
  US 20100268314A1
• Time in Patent Office: 760 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.15, 623/1.23, 623/1.22, 623/1.19, 606191-200, 606/108, 604523-532
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A stent is formed from a hollow resilient tube shaped into a helical expanded configuration to form a substantially cylindrical prosthesis that is releasably attached to an actuation shaft for delivery to a treatment site. The stent is deliverable in a substantially linear configuration and deployed with internal fluid pressure, which is delivered through the actuation shaft, to return to the helical expanded configuration. Specifically, injection of a deployment fluid into the resilient tube that forms the stent causes the stent to revert or spring back from the substantially linear delivery configuration to the original helical configuration, and in some applications to dilate a vessel. A ring is attached to a distal end of the stent to couple the stent system to a guidewire for delivery through the vasculature.

Claims

1. A stent system comprising:

an actuation shaft having an elongated tubular body defining a lumen;

a stent releasably attached to the actuation shaft and formed from a resilient tube having a fluid passageway in fluid communication with the actuation shaft lumen, the stent having a helical expanded configuration where the resilient tube forms consecutive loops which have a blood flow lumen therethrough and a linear delivery configuration where the loops of the resilient tube are substantially straightened,

wherein the stent is transformable from the delivery configuration to the helical expanded configuration through introduction of a deployment fluid into the fluid passageway of the resilient tube via the actuation shaft lumen;

a guidewire with an elongated body having a reduced diameter distal portion; and

a ring attached to a distal end of the stent, wherein the ring is slidable over the guidewire distal portion to abut a step in the guidewire.

2. The stent system of claim 1, wherein the ring is an annular member having an inner diameter only slightly larger than the guidewire reduced diameter distal portion and having an outer diameter substantially the same as the diameter of a remainder of the guidewire elongated body.

3. The stent system of claim 2, wherein the ring is fixedly attached to the distal end of the stent.

4. The stent system of claim 2, wherein the ring is an integrally formed portion of the resilient tube.

5. The stent system of claim 1, further comprising:

a guidewire with an elongated body having an annular groove located proximal to a distal end of the guidewire with a reduced diameter; and

a ring attached to a distal end of the stent, wherein the ring is seated within the annular groove of the guidewire.

6. The stent system of claim 5, wherein a breakable connection is formed between the ring and the stent by an area of weakness.

7. The stent system of claim 1, wherein a port is located at a proximal end of the resilient tube that forms the stent for receiving a connector attached to a distal end of the actuation shaft.

8. The stent system of claim 7, wherein the port includes a self-healing seal material.

9. The stent system of claim 7, wherein the connector is a rigid tubular component sized to have an interference fit with the port.

10. A method of using a stent system within a vessel comprising the steps of:

introducing a stent system into the vasculature, the stent system including an elongate tubular actuation shaft defining a lumen with a stent releasably attached at a distal end of the actuation shaft and formed from a resilient tube having a fluid passageway in fluid communication with the actuation shaft lumen, the stent having a helical expanded configuration where the resilient tube forms consecutive loops which have a blood flow lumen therethrough and a linear delivery configuration where the loops of the resilient tube are substantially straightened, the stent system further including a guidewire with an elongated body having a reduced diameter distal portion and a ring attached to a distal end of the stent, wherein the ring is slidable over the guidewire distal portion to abut a step in the guidewire;

tracking the stent system through the vasculature, wherein the stent is in the substantially linear delivery configuration;

positioning the stent at a treatment site within the vessel;

and introducing a pressurized deployment fluid through the actuation shaft lumen into the fluid passageway of the resilient tube that forms the stent to thereby transform the stent from the substantially linear delivery configuration into the helical expanded configuration.

11. The method of claim 10, further comprising the step of:

detaching the actuation shaft from the stent and retracting the actuation shaft from the vessel leaving the expanded stent at the treatment site.

12. The method of claim 11, wherein a self-healing seal is located at a proximal end of the resilient tube that forms the stent which closes upon detachment of the actuation shaft such that the stent contains the pressurized deployment fluid.

13. The method of claim 10, wherein the pressurized fluid is saline.

14. The method of claim 10, wherein the pressurized fluid includes a fixturing agent that cures from a fluid state to a solid state in the fluid passageway of the resilient tube that forms the stent after the stent is returned to the helical expanded configuration.

15. The method of claim 10, wherein the catheter shaft and stent are coupled to the guidewire during the step of tracking the stent system through the vasculature.

16. The method of claim 15, wherein the reduced diameter distal portion is an annular groove in the guidewire located proximate a distal end of the guidewire.

17. The method of claim 16 further comprising the step of:

detaching the ring from the stent; and

retracting the guidewire from the vasculature with the detached ring seated within the annular groove of the guidewire.

18. The method of claim 10, wherein the step of positioning the stent at a treatment site includes positioning the stent within a stenosis in the vessel and the method further includes using the pressurized fluid to dilate the stenosis as the stent is transformed into the helical expanded configuration.

19. The method of claim 18, further comprising the step of:

retracting the stent system from the treatment site for removal from the vasculature.