Intravascular Flow Modifier And Reinforcement Device And Deployment System For Same

• US 20080021535A1
• Filed: 08/13/2007
• Published: 01/24/2008
• Est. Priority Date: 02/14/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Micrus Corporation (Johnson & Johnson)
• Inventors: Padilla, Neal, Friedmann, Josef, Leopold, Eric
• Granted Patent: US 8,398,700 B2
• Time in Patent Office: Days
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A stent includes a cylindrical frame consisting of a series of helical winds containing a pattern of alternating zigzag bends. The frame may be made of resilient wire or from a piece of laser cut hypo tubing by placing the stent over a notched portion of a pusher catheter member, and retained on the pusher catheter member by a release wire threaded through the pusher catheter member and over the stent. The stent may also be deployed by placing the stent over a pusher catheter member having opposing notched portions, and retaining the stent and pusher catheter member in a delivery catheter, which can be withdrawn when stent reaches the site to be treated to release the stent.

Claims

1. A system for deploying an intravascular flow modifier and reinforcement device for use in the intravascular treatment of a target site in a patient'"'"'s vasculature, the intravascular flow modifier and reinforcement device including a generally cylindrical frame formed of an elongate resilient wire configured as a series of helical windings, the system comprising:

a substantially tubular pusher catheter member having an inner lumen, a proximal portion, a distal portion, a tubular main shaft, and a notched portion having at least one notch formed in a side of the pusher catheter member for receiving at least one said helical winding; and

means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member, said means for removably retaining being capable of being withdrawn from said notched portion of said pusher catheter member when the intravascular flow modifier and reinforcement device is positioned at the site in the patient'"'"'s vasculature to be treated to release and deploy the intravascular flow modifier and reinforcement device at the site in the patient'"'"'s vasculature to be treated.

2. The system of claim 1, wherein said notched portion comprises a plurality of alternating notches and tubular shoulder portions formed in said substantially tubular pusher catheter member.

3. The system of claim 1, wherein said means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member comprises a release wire threaded through the lumen of the pusher catheter member and over said at least one helical winding to retain said at least one helical winding on said notched portion of said pusher catheter member.

4. The system of claim 2, wherein a plurality of said helical windings of the intravascular flow modifier and reinforcement device are received in each of said notches.

5. The system of claim 3, further comprising a delivery catheter, and wherein said substantially tubular pusher catheter member and the intravascular flow modifier and reinforcement device received on said notched portion of said pusher catheter member are disposed in the delivery catheter, and wherein said delivery catheter can be withdrawn along with said release wire from said notched portion of said pusher catheter member when the intravascular flow modifier and reinforcement device is positioned at the site in the patient'"'"'s vasculature to be treated for delivery of the intravascular flow modifier and reinforcement device to the site in the patient'"'"'s vasculature to be treated.

6. The system of claim 1, wherein said notched portion comprises a first plurality of notches on one side of the shaft, and a second plurality of notches on an opposing side of the shaft.

7. The system of claim 6, wherein said means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member comprises a delivery catheter, and wherein said substantially tubular pusher catheter member and the intravascular flow modifier and reinforcement device received on said notched portion of said pusher catheter member are disposed in the delivery catheter, and wherein said delivery catheter can be withdrawn from said notched portion of said pusher catheter member when the intravascular flow modifier and reinforcement device is positioned at the site in the patient'"'"'s vasculature to be treated for delivery of the intravascular flow modifier and reinforcement device to the site in the patient'"'"'s vasculature to be treated.

8. The system of claim 6, wherein individual ones of said notches of said second plurality of notches are offset from corresponding ones of said first plurality of notches.

9. The system of claim 7, wherein said delivery catheter has an inner diameter that is only slightly larger than an outer diameter of the pusher catheter member, so as to retain the intravascular flow modifier and reinforcement device on the pusher catheter member.

15. The system of claim 1, wherein said generally cylindrical frame consists of a single elongate resilient wire configured as a series of helical windings, each of said helical windings including a series of between 4 and 8 alternating zigzag bends in a rotation of the wire, said generally cylindrical frame having a longitudinal axis, a deployed configuration and a predeployed compressed configuration for placement of the intravascular flow modifier and reinforcement device at the target site, said generally cylindrical frame in its deployed configuration having a helical pattern of sharp alternating zigzag bends aligned to have a chevron configuration when viewed from a first direction transverse to the longitudinal axis, and a reverse chevron configuration when viewed from a second direction transverse to the longitudinal axis.

16. The system of claim 15, wherein said deployed configuration comprises a generally cylindrical configuration.

17. The system of claim 15, wherein said predeployed compressed configuration comprises a radially compressed configuration.

18. The system of claim 15, wherein said alternating zigzag bends have an angle that is less than about 120°

to promote laminar arterial flow.

19. The system of claim 15, wherein said helical windings have a variable pitch.

20. The system of claim 15, wherein each of said helical windings comprises a series of 4 alternating zigzag bends in a rotation of the wire.

21. The system of claim 15, wherein each of said helical windings comprises a series of 6 alternating zigzag bends in a rotation of the wire.

22. The system of claim 15, wherein said elongate resilient wire is formed of a superelastic material.

23. The system of claim 15, wherein said elongate resilient wire is formed of a shape memory material.

24. The system of claim 15, wherein said elongate resilient wire is formed of a nickel-titanium alloy.

25. The system of claim 15, wherein said elongate resilient wire is coated with a corrosion resistant material.

26. The system of claim 15, wherein said elongate resilient wire is coated with Parylene.

27. The system of claim 15, wherein said elongate resilient wire is treated by chemical electropolishing to maximize corrosion resistance.

28. The system of claim 15, wherein said elongate resilient wire comprises a stranded cable including one or more radiopaque strands.

29. The system of claim 15, wherein said elongate resilient wire comprises a stranded cable having radiopaque markers deployed along the said stranded cable.

30. The system of claim 29, wherein said stranded cable is made of a material selected from the group consisting of stainless steel, shape-memory alloy, superelastic alloy, platinum and combinations thereof.

31. The system of claim 15, wherein said elongate resilient wire is formed by laser cutting a piece of tubing.

10. A method for deploying an intravascular flow modifier and reinforcement device for use in the intravascular treatment of a target site in a patient'"'"'s vasculature, the intravascular flow modifier and reinforcement device including a generally cylindrical frame formed of an elongate resilient wire configured as a series of helical windings, the steps of the method comprising:

releasably mounting at least one helical winding of the intravascular flow modifier and reinforcement device on notched portion of a substantially tubular pusher catheter member, said notched portion having at least one notch formed in a side of the pusher catheter member for receiving said at least one helical winding;

disposing a means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member over said at least one helical winding;

positioning said means for removably retaining the intravascular flow modifier and reinforcement device at the site in the patient'"'"'s vasculature to be treated; and

withdrawing said means for removably retaining from said notched portion of said pusher catheter member to release and deploy the intravascular flow modifier and reinforcement device at the site in the patient'"'"'s vasculature to be treated.

11. The method of claim 10, wherein said means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member comprises a release wire threaded through the pusher catheter member and over said at least one helical winding to retain said at least one helical winding on said notched portion of said pusher catheter member, and said step of withdrawing said means for removably retaining from said notched portion of said pusher catheter member comprises withdrawing said release wire from said notched portion.

12. The method of claim 10, wherein said means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member comprises a delivery catheter having an inner diameter that is only slightly larger than an outer diameter of the pusher catheter member, so as to retain the intravascular flow modifier and reinforcement device on the pusher catheter member, said notched portion and said at least one helical winding of the intravascular flow modifier and reinforcement device being disposed in said delivery catheter, and said step of withdrawing said means for removably retaining from said notched portion of said pusher catheter member comprises withdrawing said delivery catheter from said notched portion.

13. A system for deploying an intravascular flow modifier and reinforcement device for use in the intravascular treatment of a target site in a patient'"'"'s vasculature, the intravascular flow modifier and reinforcement device including a generally cylindrical frame formed of an elongate resilient wire configured as a series of helical windings, the system comprising:

a substantially tubular pusher catheter member having an inner lumen, a proximal portion, a distal portion, a tubular main shaft, and a notched portion having at least one notch formed in a side of the pusher catheter member for receiving at least one said helical winding, said substantially tubular pusher catheter member being formed of a nickel-titanium alloy; and

means for removably retaining said at least one helical winding on said notched portion of said pusher catheter member, said means for removably retaining being capable of being withdrawn from said notched portion of said pusher catheter member when the intravascular flow modifier and reinforcement device is positioned at the site in the patient'"'"'s vasculature to be treated to release and deploy the intravascular flow modifier and reinforcement device at the site in the patient'"'"'s vasculature to be treated.

14. A system for deploying an intravascular flow modifier and reinforcement device for use in the intravascular treatment of a target site in a patient'"'"'s vasculature, the intravascular flow modifier and reinforcement device including a generally cylindrical frame formed of an elongate resilient wire configured as a series of helical windings, the system comprising:

a substantially tubular pusher catheter member having an inner lumen, a proximal portion, a distal portion, a tubular main shaft, and a notched portion having at least one notch formed in a side of the pusher catheter member for receiving at least one said helical winding; and

a release wire for removably retaining said at least one helical winding on said notched portion of said pusher catheter member, said release wire being threaded through the lumen of the pusher catheter member and over said at least one helical winding to retain said at least one helical winding on said notched portion of said pusher catheter member, said release wire being capable of being withdrawn from said notched portion of said pusher catheter member when the intravascular flow modifier and reinforcement device is positioned at the site in the patient'"'"'s vasculature to be treated to release and deploy the intravascular flow modifier and reinforcement device at the site in the patient'"'"'s vasculature to be treated, said release wire being formed of a nickel-titanium alloy.