BRAIDED STENT WITH EXPANSION RING AND METHOD OF DELIVERY

Abstract

A self-expanding braided stent includes at least a distal radial expansion ring added to a distal end of the stent body to increase a radial expansion force of the self-expanding braided stent in deployment of the stent, and to facilitate advancement of the stent through a delivery sheath by a core advancement wire. A proximal radial expansion ring is optionally added to a proximal end of the stent body to allow the stent to be recaptured following partial deployment by retraction of the core advancement wire, prior to full deployment of a proximal portion of the stent body.

Claims

1. An apparatus for delivering and releasing a self-expanding braided stent through a delivery sheath to a treatment site in a patient’s vasculature, said apparatus comprising: a tubular self-expanding braided stent body having a proximal end, a distal end, and an inner lumen, said tubular self-expanding braided stent body being formed from a plurality of elongate members, said tubular self-expanding braided stent body having a compressed configuration and an expanded configuration; at least one expansion ring disposed within and fixedly connected to said distal end of said tubular self-expanding braided stent body, said at least one expansion ring having a proximal interior end, a distal exterior end approximate the distal end of said tubular self-expanding braided stent body, and an inner lumen, said at least one expansion ring having a compressed configuration having a first diameter and an expanded configuration having a second diameter larger than said first diameter; a core advancement wire disposed within and extending through said inner lumen of said tubular self-expanding braided stent body and said inner lumen of said at least one expansion ring, said core advancement wire having: a proximal portion, a distal portion, an intermediate portion located between said proximal and distal portions of said core advancement wire, a proximal stop member on said core advancement wire positioned outside and proximal to said proximal end of said tubular self-expanding braided stent body, said proximal stop member having a diameter greater than or equal to an unexpanded diameter of the compressed configuration of said tubular self-expanding braided body and less than a diameter of the delivery sheath, and a distal stop member positioned between said distal portion and said intermediate portion of said core advancement wire and immediately adjacent to said proximal interior end of said at least one expansion ring, said distal stop member being configured to press distally into said proximal interior end of said at least one expansion ring when the said core advancement wire is advanced distally, whereby force applied distally to said core advancement wire is transmitted through said at least one expansion ring to said distal end of said tubular self-expanding braided stent body and acts to drag and elongate said tubular self-expanding braided stent body, and wherein said core advancement wire is configured to reduce friction of said tubular self-expanding braided stent body with said delivery sheath when force is applied distally to said core advancement wire.

2. The apparatus of claim 1, wherein said at least one expansion ring is formed of shape memory material having a shape memory position in said expanded configuration.

3. The apparatus of claim 1, wherein said at least one expansion ring comprises a plurality of elongated connecting arm members having first ends at said first end of said at least one expansion ring and second ends at said second end of said at least one expansion ring, said plurality of elongated connecting arm members being connected sequentially to adjacent ones of said plurality of elongated connecting arm members alternatingly at said first and second ends to form a plurality of alternating elbow connections at said first and second ends.

4. The apparatus of claim 3, further comprising a plurality of attachment tabs connected to said plurality of alternating elbow connections at said proximal interior end of said at least one expansion ring, wherein said plurality of alternating elbow connections at said proximal interior end of said at least one expansion ring have exterior ends directed away from said plurality of elongated connecting arm members and said plurality of attachment tabs are connected to said exterior ends of said plurality of alternating elbow connections at said proximal interior end of said at least one expansion ring, and wherein said plurality of attachment tabs are fixedly attached to said tubular self-expanding braided stent body.

5. The apparatus of claim 1, wherein said distal stop member comprises an enlarged portion of said core advancement wire having a diameter greater than or equal to said first diameter of said compressed configuration of said at least one expansion ring disposed within and fixedly connected to said distal end of said tubular self-expanding braided stent body.

6. The apparatus of claim 1, further comprising a second expansion ring having a distal interior end, a proximal exterior end, and an inner lumen, the second expansion ring being disposed within and fixedly connected to said proximal end of said tubular self-expanding braided stent body, said core advancement wire further including an intermediate stop member on said core advancement wire positioned on said intermediate portion of said core advancement wire within said inner lumen of said tubular self-expanding braided stent body.

7. The apparatus of claim 6, wherein said intermediate stop member is positioned within said inner lumen of said tubular self-expanding braided stent body distal to said second expansion ring and immediately adjacent to said distal interior end of said second expansion ring.

8. The apparatus of claim 7, wherein said intermediate stop member comprises an enlarged portion of said core advancement wire having a diameter greater than or equal to a first diameter of a compressed configuration of said second expansion ring.

9. An apparatus for delivering and releasing a self-expanding stent through a delivery sheath to a treatment site in a patient’s vasculature, said apparatus comprising: a tubular self-expanding braided stent body having a proximal end, a distal end, and an inner lumen, said tubular self-expanding braided stent body being formed from a plurality of elongate members, said tubular self-expanding braided stent body having a compressed configuration and an expanded configuration; a distal expansion ring and a proximal expansion ring, said distal expansion ring disposed within and fixedly connected to said distal end of said tubular self-expanding braided stent body, said proximal expansion ring disposed within and fixedly connected to said proximal end of said tubular self-expanding braided stent body, said distal expansion ring having a proximal interior end, a distal exterior end approximate the distal end of said tubular self-expanding braided stent body, and an inner lumen, and said proximal expansion ring having a distal interior end approximate the proximal end of said tubular self-expanding braided stent body, a proximal exterior end, and an inner lumen, each of said distal and proximal expansion rings having a compressed configuration having a first diameter and an expanded configuration having a second diameter larger than said first diameter; and a core advancement wire disposed within and extending through said inner lumen of said tubular self-expanding braided stent body and said inner lumen of said distal and proximal expansion rings, said core advancement wire having: a proximal portion, a distal portion, an intermediate portion located between said proximal and distal portions of said core advancement wire, a distal stop member positioned between said distal portion and said intermediate portion of said core advancement wire within said inner lumen of said tubular self-expanding braided stent body distal to said proximal expansion ring and immediately adjacent to said proximal interior end of said distal expansion ring, said distal stop member being configured to press distally into said proximal interior end of said distal expansion ring when the said core advancement wire is advanced distally, whereby force applied distally to said core advancement wire is transmitted through said distal expansion ring to said distal end of said tubular self-expanding braided stent body and acts to drag and elongate said tubular self-expanding braided stent body, and an intermediate stop member positioned on said intermediate portion of said core advancement wire within said inner lumen of said tubular self-expanding braided stent body distal to said proximal expansion ring and immediately adjacent to said distal interior end of said proximal expansion ring, said intermediate stop member being configured to press proximally into said distal interior end of said proximal expansion ring when said core advancement wire is retracted proximally, allowing retraction of said tubular self-expanding braided stent body within the delivery sheath, wherein said core advancement wire is configured to reduce friction of said tubular self-expanding braided stent body with said delivery sheath when force is applied distally to said core advancement wire.

10. The apparatus of claim 9, wherein at least one of said proximal expansion ring and said distal expansion ring is formed of shape memory material having a shape memory position in said expanded configuration.

11. The apparatus of claim 9, wherein each of said distal and proximal expansion rings include a plurality of elongated connecting arm members having first ends at said proximal interior end of said distal expansion ring and said distal interior end of said proximal expansion ring and second ends at said distal exterior end of said distal ring and said proximal exterior end of said proximal expansion ring, said plurality of elongated connecting arm members being connected sequentially to adjacent ones of said plurality of elongated connecting arm members alternatingly at said first and second ends to form a plurality of alternating elbow connections at said first and second ends having a zigzag configuration, and wherein said plurality of elongated connecting arm members and said plurality of alternating elbow connections are configured to be compressed into a small tubular shape during delivery.

12. The apparatus of claim 11, further comprising a plurality of attachment tabs connected to said plurality of alternating elbow connections at said proximal interior end of said distal expansion ring and said distal interior end of said proximal expansion ring, wherein said plurality of alternating elbow connections at said proximal interior end of said distal expansion ring and said distal interior end of said proximal expansion ring have exterior ends directed away from said plurality of elongated connecting arm members and said plurality of attachment tabs are connected to said exterior ends of said plurality of alternating elbow connections at said proximal interior end of said distal expansion ring and said distal interior end of said proximal expansion ring, and wherein said plurality of attachment tabs are fixedly attached to said tubular self-expanding braided stent body.

13. The apparatus of claim 9, wherein said distal stop member comprises an enlarged portion of said core advancement wire having a diameter greater than or equal to said first diameter of said compressed configuration of said distal expansion ring.

14. The apparatus of claim 9, further comprising a proximal stop member on said core advancement wire positioned outside and proximal to said proximal end of said tubular self-expanding braided stent body, said proximal stop member having a diameter greater than or equal to said first diameter of said compressed configuration of said distal expansion ring and less than a diameter of the delivery sheath.

15. The apparatus of claim 9, wherein said intermediate stop member comprises an enlarged portion of said core advancement wire having a diameter greater than or equal to said first diameter of said compressed configuration of said proximal expansion ring.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is a perspective view of an expansion ring configured to be affixed within a braided stent, according to the invention.

[0018] FIG. 2 is a cross-sectional schematic elevational view of an expansion ring of FIG. 1 affixed within an initial deployment end or distal end of a braided stent, shown contained within a delivery sheath or microcatheter, according to the invention.

[0019] FIG. 3 is a cross-sectional schematic elevational view similar to FIG. 2, showing partial deployment of the initial deployment end or distal end of the braided stent from the delivery sheath or microcatheter of FIG. 2.

[0020] FIG. 4 is a cross-sectional schematic elevational view of an expansion ring of FIG. 1 affixed within an initial deployment end or distal end of a braided stent, shown contained within a delivery sheath or microcatheter, and including a core advancement wire extending through the braided stent and expansion ring, according to the invention.

[0021] FIG. 5 is a cross-sectional schematic elevational view similar to FIG. 4, showing partial deployment of the initial deployment end or distal end of the braided stent from the delivery sheath or microcatheter of FIG. 4.

[0022] FIG. 6 is a cross-sectional schematic elevational view of a braided stent having a distal expansion ring and a proximal expansion ring affixed within the distal and proximal ends of the braided stent, shown contained within a delivery sheath or microcatheter, and including a core advancement wire extending through the braided stent and expansion ring, according to the invention.

[0023] FIG. 7 is a cross-sectional schematic elevational view similar to FIG. 6, showing partial deployment of the initial deployment end or distal end of the braided stent from the delivery sheath or microcatheter of FIG. 6.

[0024] FIG. 8 is a cross-sectional schematic elevational view similar to FIG. 6, showing retraction of the initial deployment end or distal end of the braided stent into the delivery sheath or microcatheter of FIG. 6.

[0025] FIG. 9 is a cross-sectional schematic elevational view similar to FIG. 6, showing implantation of a braided stent at a treatment site in a patient’s vasculature, and withdrawing of the core advancement wire and delivery sheath or microcatheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] While stents have commonly been delivered in in blood vessels such as during intravascular angioplasty treatment of occluded cardiac arteries, by use of inflatable balloons or mechanical devices that force a stent open, the weakness and tortuosity of the neurovasculature places limits on the applicability of such stents in procedures to repair neurovascular defects, and it is desirable to provide an improved self-expanding braided stent with increased its radial expansion force, particularly at the initial deployment end or distal end, that can also reduce the internal friction of the braided stent during delivery of the braided stent through a delivery sheath or microcatheter, that can be more reliably expanded and fixed at the initial deployment end or distal end of the self-expanding braided stent, and that can be recaptured following partial deployment of a distal portion of the self-expanding braided stent prior to full deployment of a later deployed portion or proximal portion of the self-expanding braided stent.

[0027] Accordingly, referring to the drawings, which are provided by way of example, and not by way of limitation, in a first embodiment, for treatment of a patient’s vasculature, the present invention provides for a braided stent 10 including a tubular braided stent body 11, having a later deployed end or proximal end 12, an initial deployment end or distal end 14, and an inner lumen 16 as shown in FIG. 1. The tubular braided stent body is preferably formed from a plurality of elongate members 18, typically formed from two or more metal wires, or polymeric fibers or strands of material, for example. In a presently preferred aspect, the braided stent is a self-expanding stent, and includes one or more expansion rings 20, each having a first end 22, a second end 24, and an inner lumen 26. The one or more expansion rings preferably are disposed within and fixedly connected to at least the initial deployment end or distal end of the tubular braided stent body, although one or more expansion rings may also be disposed within and fixedly connected to the later deployed end or proximal end of the tubular braided stent body, as will be further explained below.

[0028] Each expansion ring includes a plurality of elongated connecting arm members 30 having first ends 32 at the first end of the expansion ring, and second ends 34 at the second end of the expansion ring. The plurality of elongated connecting arm members 30 are connected sequentially to adjacent ones of the plurality of elongated connecting arm members 30 alternatingly at the first and second ends (32, 34) to form a plurality of alternating elbow connections 36 at the first and second ends of the expansion ring 20, so that the plurality of elongated connecting arm members 30 of each expansion ring 20 substantially have a zigzag configuration.

[0029] Referring to FIGS. 2, 3 and 4, each expansion ring preferably is formed to have a compressed configuration 38, having a first diameter, and an expanded configuration 42, having a second diameter that is larger than the first diameter of the compressed configuration 38 of the expansion ring 20. Each expansion ring 20 is preferably formed of a shape memory material such as a nickel-titanium alloy, or a shape memory polymer, for example, having a shape memory position in the expanded configuration 42. For example, the expansion rings 20 may be appropriately heat treated so that the expansion ring 20 forms in the desired shape of the expanded shape memory position 42, with the plurality of elongated connecting arm members 30 having a substantially zigzag type configuration. Each expansion ring 20 is typically formed by cutting a tube formed of a shape memory material such as a nickel-titanium alloy, or a shape memory polymer, for example, by an appropriate laser. The plurality of elongated connecting arm members 30 and the alternating elbow connections 36 preferably can be compressed in the compressed configuration 38 into a tubular shape that is small enough to comfortably fit within and pass through a delivery sheath or microcatheter 44 to allow delivery of the stent through the delivery sheath or microcatheter 44 to a treatment site in a patient’s vasculature 52.

[0030] In another presently preferred aspect, each expansion ring 20 includes a plurality of attachment tabs 46 connected to the plurality of alternating elbow connections 36 at the first ends 32 of the expansion ring 20. The plurality of attachment tabs 46 preferably are connected to exterior ends 48 of the plurality of alternating elbow connections 36 at the first ends 32 of the one or more expansion ring 20. The plurality of attachment tabs 46 preferably are fixedly connected to a tubular braided stent body 10, typically at or near a distal 14 or proximal 12 end of the tubular braided stent body 10, such as by welding, soldering, or gluing by an appropriate adhesive, for example. Alternatively, the attachment tabs 46 can include holes in them so that a wire loop can be threaded through the attachment tabs 46, as well as through interstices of the braided stent 10 to connect the attachment tabs 46 and the braided stent 10 together. In addition, two or more attachment tabs 46 can be included at the ends of each elbow connection 36 of the expansion ring 20, and the attachment tabs 46 can then be used to capture a portion of the braided stent 10 between them, after which the two or more attachment tabs 46 can be secured together to be permanently secured to the braided stent 10 by welding, soldering, adhesive, or the like. At least one first, distal, expansion ring 20a preferably is disposed within and fixedly connected to the initial deployment end or distal end 14 of the tubular braided stent body 10. As is illustrated in FIGS. 6-9, a second, proximal, expansion ring 20b preferably also is disposed within and fixedly connected to the later deployed end or proximal end 14 of the tubular braided stent body 10.

[0031] Referring to FIGS. 4-9, in a second embodiment, in which like elements are indicated by like reference numbers, the present invention further provides for an apparatus 50 for delivering and releasing a self-expanding braided stent 10 through a delivery sheath or microcatheter 44 to a treatment site in a patient’s vasculature 52. The apparatus includes a braided stent including a tubular braided stent body 10, described above, and also includes a core advancement wire 54, which is disposed within and extends through the lumen of the tubular braided stent body 10, and is disposed within and extending through the lumen of the distal expansion ring 20a fixedly connected within the initial deployment end or distal end 12 of the tubular braided stent body 10. When a proximal expansion ring 20b is fixedly connected within the later deployed end or proximal end 12 of the tubular braided stent body 10, as is illustrated in FIGS. 6-9, the core advancement wire 54 also is disposed within and extends through the lumen of the proximal expansion ring 20b.

[0032] The core advancement wire 54 includes a proximal portion 56, a distal portion 58, an intermediate portion 60 located between the proximal and distal portions of the core advancement wire 54, and a distal stop member 62 positioned between the distal portion 58 and the intermediate portion 60 of the core advancement wire 54. In one presently preferred aspect, as is shown in FIG. 4, the distal stop member 62 is formed as an enlarged portion of the core advancement wire 54 having a diameter greater than or equal to the first diameter of the compressed configuration 38 of the expansion ring 20. The distal stop member 62 is preferably configured to engage a proximal, interior side 64 of the distal expansion ring 20a when the core advancement wire 54 is advanced distally, so that force applied distally to the core advancement wire 54 is transmitted through the distal stop member 62 to the distal expansion ring 20a, and consequently is transmitted to the initial deployment end or distal end 14 of the braided stent 10, thereby acting to drag the braided stent 10 in a distal direction, as the braided stent 10 is delivered through the delivery sheath or microcatheter 44 to a treatment site, as well as to elongate the braided stent 10 , advantageously also reducing friction with the delivery sheath or microcatheter 44 through which the braided stent 10 is delivered.

[0033] In another preferred aspect, a proximal stop member 66 may also be provided on the core advancement wire 54 positioned outside and proximal to the proximal end 12 of the braided stent 10. When it is provided, the proximal stop member 66 preferably has a diameter greater than or equal to the unexpanded diameter of the compressed configuration 38 of the braided stent 10 and less than a diameter of the delivery sheath or microcatheter 44.

[0034] The self-expanding braided stent 10 can be delivered and released through the delivery sheath or microcatheter 44 to a treatment site in a patient’s vasculature by advancing the core advancement wire 54 distally (to the left as shown), so that the distal stop member 62 of the core advancement wire 54 engages the proximal, interior side 64 of the distal expansion ring 20a. Since the distal expansion ring 20a is attached to the braided stent 10, force applied distally to the core advancement wire 54 is transmitted through the distal expansion ring 20a to the initial deployment end or distal end 14 of the braided stent 10, and the force applied to the initial deployment end or distal end 14 of the braided stent 10 in the distal direction therefore tends to drag and elongate the braided stent 10, consequently reducing the diameter of the compressed configuration 38 of the braided stent 10, reducing the friction between the braided stent 10 and the delivery sheath or microcatheter 44.

[0035] In another embodiment illustrated in FIGS. 6-9, in which like elements are indicated by like reference numbers, the present invention further provides for an apparatus for delivering and releasing a self-expanding braided stent 10 through a delivery sheath or microcatheter 44 to a treatment site in a patient’s vasculature, in which the core advancement wire 54 also includes an intermediate stop member 68 positioned on the intermediate portion 60 of the core advancement wire 54, within the lumen of the braided stent 10 distal to the proximal expansion ring 20b. The intermediate stop member 68 preferably is formed as an enlarged portion of the core advancement wire 54 having a diameter that is greater than or equal to the first diameter of the compressed configuration 38 of the proximal expansion ring 20b. The intermediate stop member 68 preferably is configured to engage the distal, interior side 70 of the proximal expansion ring 20b when the core advancement wire 54 is retracted proximally, allowing retraction of the braided stent 10 within the delivery sheath or microcatheter 44.

[0036] In this embodiment, the self-expanding braided stent 10 can be delivered and released through the delivery sheath or microcatheter 44 to a treatment site in a patient’s vasculature by advancing the core advancement wire 54 distally, as described above, and the core advancement wire 54 may also then be retracted proximally (to the right as shown in FIG. 8), so that the intermediate stop member 68 engages the distal, interior side 70 of the proximal expansion ring 20b. As long as the braided stent 10 is not deployed past the proximal expansion ring 20b, the braided stent 10 can be recaptured in this way. The retraction force applied proximally to the core advancement wire 54 is transmitted through the proximal expansion ring 20b to the proximal end 12 of the braided stent 10, and as the braided stent 10 is recaptured back into the delivery sheath or microcatheter 44, the initial deployment end or distal end 14 of the braided stent 10 is reduced in diameter by the mouth 72 of the delivery sheath or microcatheter 44 until the braided stent 10 is again fully enclosed by the delivery sheath or microcatheter 44.

[0037] It will be apparent from the foregoing that while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.