# Patent

## Title
Intravascular implants and methods of using the same

## Abstract

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 13/666,756, filed on Nov. 1, 2012, which is a continuation of U.S. patent application Ser. No. 11/351,423, filed on Feb. 10, 2006, which is a continuation of U.S. patent application Ser. No. 10/778,870, filed on Feb. 12, 2004, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/447,056, filed on Feb. 12, 2003, the contents of all which are incorporated herein by reference in their entireties.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to an intravascular implant and methods of using the implant within the vasculature of the body, particularly adjacent to vascular aneurysms. The present invention also relates to the attachment of a second implant, such as a vascular graft, to the intravascular implant.
2. Description of the Related Art
An aneurysm is an abnormal dilatation of a biological vessel. Aneurysms can alter flow through the affected vessel and often decrease the strength of the vessel wall, thereby increasing the vessel's risk of rupturing at the point of dilation or weakening. Implanting a vascular prosthesis through the vessel with the aneurysm is a common aneurysm therapy. Vascular grafts and stent grafts (e.g., ANEURX® Stent Graft System from Medtronic AVE, Inc., Santa Rosa, Calif.) are examples of vascular prostheses used to treat aneurysms by reconstructing the damaged vessel.
Stent grafts rely on a secure attachment to the proximal, or upstream, neck of an aneurysm, particularly for aortic abdominal aneurysms (AAA), but several factors can interfere with this attachment. The proximal neck of the aneurysm can be diseased. This diseased tissue can by a calcified and/or irregularly shaped tissue surface for which the graft must to attach. Healthy, easily-attachable tissue is often a distance away from the aneurysm. For example, in AAAs the nearest healthy vascular tissue may be above the renal arteries. Even a healthy vessel can be so irregularly shaped or tortuous that a graft may have difficulty attaching and staying sealed. Furthermore, the proximal neck can shift locations and geometries over time, particularly over the course of aneurysm treatment and reformation of the aneurysmal sack. This shifting and shape changing of the vessel can result in partial or total dislodgement of the proximal end of a currently available stent graft.
Devices have been developed that attempt to solve the issue of vascular graft attachment. International Publication No. WO 00/69367 by Strecker discloses an aneurysm stent. The stent has a securing mechanism that attaches to the vascular wall proximal to the renal arteries, which is typically where healthier vascular tissue is located when a patient has an AAA. The stent also has a membrane that is placed at the proximal end of a stent graft and forms a seal in the vessel. Strecker, however, discloses a securing mechanism with ball-ended struts which angle away from the seal. The ball-ends will reduce the pressure applied by the struts onto the vascular wall, and the struts are angled improperly to insure the best anchor. If the graft begins to dislodge into the aneurysm, the struts will tend to fold inward and slide with the graft instead of engaging frictionally into the vascular walls to prevent dislodgement.
U.S. Pat. No. 6,152,956 to Pierce discloses a radially expandable collar connected by connecting wires to an expandable stent. The stent also has barbs with sharp ends that spring radially outward to embed into the walls of the vascular tissue. The stent, however, is expandable, but once expanded cannot be easily contracted. The stent, therefore, can not be repositioned if incorrectly placed during initial deployment. Further, the barbs do not angle toward the seal and will not engage into the vascular wall for additional anchoring force, should the prosthesis begin to become dislodged.
U.S. Pat. No. 6,361,556 by Chuter discloses a stent for attaching to grafts, where the stent is connected to an attachment system for anchoring to the vessel. The attaching system has hooks angled toward the graft. The attachment system has no way of being repositioned during deployment. Further, the stent is a substantially rigid, balloon expandable stent and therefore maintains a fixed diameter and resists deformation from forces imposed by the vascular environment. The stent, therefore, can not be easily repositioned during deployment and may not seal the graft under changing geometric conditions over time.
There is thus a need for a device and method that can securely anchor a vascular graft within a vessel and can seal the graft regardless of the existence of diseased tissue at the sealing location. There is also a need for a device that can be deployed to the vasculature while minimizing bloodflow obstruction to the main vessel and to branching vessels. A need also exists for a device and method that can accomplish the above needs and adjust to tortuous vasculature. There is also a need for a device and method that can accomplish the above and have dimensions and a placement location that can be adjusted multiple times in vivo, even after the anchor has been fully deployed. There is also a need for a device that can be delivered through a low profile catheter. Additionally, there is a need for a device that can anchor into a different portion of tissue from which it seals, so as not to overstress any individual portion of vascular tissue or any elements of the implant, thus preventing fractures in the tissue and of the implant.
BRIEF SUMMARY OF THE INVENTION
One embodiment of the disclosed intravascular implant has a seal, a connector, and an anchor. The seal is configured to attach to a second implant. The connector has a first end and a second end. The first end is attached to the seal, and the second end is attached to the anchor. The anchor has an arm, and the arm is angled toward the seal as the arm extends radially away from the center of the anchor. The anchor can be formed of multiple radially extending tines or arms such as an uncovered umbrella structure, a hook and/or a barb.
Another embodiment of the disclosed intravascular implant has a seal and a substantially cylindrical coil, where the coil is attached to, and extends from, the seal. The seal can also have a gasket. The seal can also have an inflatable collar.
Yet another embodiment of the intravascular implant has a seal, a connector and an anchor. The seal is configured to attach to a second implant. The connector has a first end and a second end and may be flexible. The first end is attached to the seal, and the second end is attached to the anchor. The connector may be formed of a coil. The connector can be configured to allow for longitudinal adjustments. The distance between the seal and the anchor can be changed. The implant can also have a second anchor to assist in additional fixation.
Another embodiment of the intravascular implant has a seal, a connector, an anchor, and a stop. The connector has a first end and a second end. The first end is attached to the seal, and the second end is attached to the anchor. The anchor has an arm and the arm is angled toward the seal as the arm extends radially from the center of the anchor. Radial extension of the arm is limited by the stop. The stop can be a mechanical interference.
Yet another embodiment of the disclosed intravascular implant has a seal, a connector and an anchor. The connector has a flexible member, a first end and a second end. The first end is attached to the seal and the second end is attached to the anchor. The anchor has an arm. The arm angles toward the seal as the arm extends radially from the center of the anchor. The seal can have a gasket. The seal can have an inflatable collar. The connector can have a coil. The implant can also have a second anchor.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front perspective view of an embodiment of the intravascular implant.
FIGS. 2 and 3 are front perspective views of various embodiments of the seal.
FIG. 4 is a top view of an embodiment of the seal ring.
FIGS. 5-8 are front perspective views of various embodiments of the seal.
FIGS. 9 and 10 are a top and a side view, respectively, of the embodiment of the seal ring shown in FIG. 8.
FIGS. 11 and 12 are front perspective views of various embodiments of the seal ring.
FIG. 13 illustrates an embodiment of cross-section A-A of the intravascular implant without the seal.
FIG. 14 is a front perspective view of an embodiment of the intravascular implant.
FIG. 15 is a perspective view of an embodiment of the attachment device.
FIG. 16 illustrates an embodiment of cross-section B-B of the seal with the connectors.
FIG. 17 is a front perspective view of an embodiment of the connector and the attachment device.
FIGS. 18-20 illustrate embodiments of the connector.
FIGS. 21-23 are front perspective views of various embodiments of the intravascular implant.
FIGS. 24 and 25 are front perspective views of various embodiments of the anchor.
FIG. 26 is a top view of an embodiment of the anchor.
FIGS. 27-29 illustrate various embodiments of the intravascular implant.
FIG. 30 illustrates an embodiment of a method for compressing the seal ring for deployment.
FIGS. 31-33 illustrate an embodiment of a method for deploying the intravascular implant into a vascular site.
FIGS. 34-37 illustrate various embodiments of radially contracting and expanding the arms of the anchor.
FIG. 38 illustrates an embodiment of a method for deploying the intravascular implant into a vascular site.
FIG. 39 illustrates an embodiment of a method for deploying the second implant with the intravascular implant.
FIGS. 40-42 illustrate an embodiment of a method for attaching the seal to the attachment device.
FIG. 43 illustrates an embodiment of the second implant.
FIGS. 44 and 45 illustrate an embodiment of a method for attaching the seal to the attachment device.
FIG. 46 illustrates an embodiment of the intravascular implant after deployment into a vascular site.



DETAILED DESCRIPTION
FIG. 1 illustrates an embodiment of an intravascular implant 2. The implant 2 can have a connector 4 having a first end 6 and a second end 8. The first end 6 can be attached to an anchor 10. The anchor 10 can have a central tip 12. The central tip 12 can be attached to the first end 6. The anchor 10 can also have multiple tines or arms 14 extending radially from the central tip 12, such as in an uncovered umbrella structure. The central tip 12 can be rotatably or flexibly attached to the arms 14. Leaves 16 can be attached at two ends to adjacent arms 14. A flow-through area 18 can be an open port defined by any leaf 16 and the arms 14 to which that leaf 16 attaches.
The second end 8 can be attached to a seal 20. The second end 8 can attach to the seal 20 through an attachment device 22, for example struts. The attachment device 22 can be integral with the second end 8, integral with the seal 20, or an independent part. Attachment devices 22 can also be used to attach the connector 4 to the anchor 10. The seal 20 can have a first proximal end 24 and a first distal end 26. A second implant 28 can be attached to the seal 20, for example at the distal end 26, or the second implant 28 can be an integral part of the seal 20.
FIG. 2 illustrates a single gasket embodiment of the seal 20. The seal 20 can have a first seal ring 30 at the proximal end 24. The seal 20 can also have a second seal ring 32 at the distal end 26. The seal rings 30 and 32 can have radially extending spring force elements or tissue mainstays 33. The tissue mainstays 33 can be, for example a barb, spike, hook, peg, a coil, pigtail or leaf spring, or any combination thereof. The seal rings 30 and 32 can be made from nickel-titanium alloy (e.g., Nitinol), titanium, stainless steel, cobalt-chrome alloy (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), polymers such as polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, silicone, radiopaque materials, or any combination thereof. Examples of radiopaque materials are barium, sulfate, titanium, stainless steel, nickel-titanium alloys and gold.
The seal 20 can have a first seal cover 34 attached at the proximal end 24 to the first seal ring 30 and at the distal end 26 to the second seal ring 32. The seal cover 34 can be made from polymers such as polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, PEEK, nylon, polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), polyglycolic acid (PGA), polyurethane, polyethylene, vascular, valvular or pericardial tissue, extruded collagen, silicone, metal mesh, radiopaque materials, or any combination thereof.
A seal flow port 36 can be the hole defined by the inner radii of the seal rings 30 and 32 and the seal cover 34. The seal 20 can have a seal diameter 38 that can depend on the diameter of the vessel in a given patient. The seal diameter 38 can be from about 5 mm (0.2 in.) to about 50 mm (2.0 in.), for example about 30 mm (1.2 in.). The seal 20 can have a seal height 40 from about 1 mm (0.04 in.) to about 6 cm (2.4 in.).
FIG. 3 illustrates an embodiment of the seal 20 that can have a first gasket 42 and a second gasket 44. Such a design can incrementally decrease the pressure across a given length so no one gasket 42 or 44 endures the entire pressure. The first gasket 42 can be similar to a single gasket seal embodiment illustrated in FIG. 2, except that the first seal cover 34 can be attached to the second seal ring 32 at a first gasket distal end 46. The second gasket 44 can have a second seal cover 48. The second seal cover 48 can be attached at a second gasket proximal end 50 to the second seal ring 32 and/or the second seal cover 48 can be integral with the first seal cover 34. The second seal cover 48 can also attach at the distal end 26 to a third seal ring 52.
FIG. 4 illustrates an embodiment of the seal rings 30, 32 and 52 (shown as 30). The seal ring 30 can have diametrically opposed thin sections 54 and diametrically opposed thick sections 56. The seal ring 20 can have a seal ring thickness 58 that can vary from a minimum in the thin sections 54 to a maximum in the thick sections 56. The seal ring 30 can also have a constant thickness along the entire circumference of the seal ring 30. The seal ring 30 can also have a gap in the circumference of the seal ring 30, forming a “c”-ring (not shown) as known to one having ordinary skill in the art.
FIG. 5 illustrates an embodiment of the seal 20 that can have a seal volume 60. The seal volume 60 can be a bladder or collar filled by a fluid, for example saline, plasma, helium, oxygen, radiopaque materials (including small pieces of solids), blood, epoxy, glue, or any combination thereof. The bladder can be inflated in vivo by a method known to those having ordinary skill in the art. The seal volume 60 can also be a solid, for example polymers such as polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, PEEK, nylon, polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), polyglycolic acid (PGA), polyurethane, polyethylene, vascular, valvular or pericardial tissue, extruded collagen, silicone, radiopaque materials, or any combination thereof.
A first and/or second seal flow ports 62 and 64, respectively, can be defined, for example as cylinders, within the seal volume 60. Once deployed, multiple seal flow ports 62 and 64 can attach to multiple second implants 28, or multiple legs of the second implant 28 that can extend distal of the seal into the iliac arteries. A connector port 66 can also be defined, for example as a cylinder, within the seal volume 60. The second end 8 of the connector 4 can be placed into the connector port 66. The seal volume 60 can be inflated after the second end 8 is placed into the connector port 66 to constrict and pressure fit the connector port 66 around the second end 8, thereby fixedly attaching the seal 20 to the connector 4.
FIG. 6 illustrates an embodiment of the seal 20 that can have a helical seal coil 68 having a first end 70 and a second end 72. The ends 70 and 72 can be dulled, for example by attaching small balls as shown. The seal coil 68 can have a number of turns 74, for example from about 1.25 turns 74 to about 50 turns 74, for example about 5 turns 74.
FIG. 7 illustrates an embodiment of the seal 20 that can have a structure similar to the anchor illustrated in FIG. 1 but with a vertically inverted orientation.
FIG. 8 illustrates an embodiment of the seal 20 that can have a first seal ring 30 and a second seal ring 32 that are mechanically insulated from each other. This structure enables the seal rings 30 and 32 to fit to more easily fit and seal an irregularly shaped vessel.
A first hub 76 can be fixedly attached or rotatably attached to first seal struts 78 and a center beam 80. The first seal struts 78 can slidably connect on the outside or inside of the first seal ring 30 at free points 82. The first seal struts 78 can be fixedly or rotatably attached to the second seal ring 32 at fixation points 84. The first seal struts 78 can be fixedly attached or rotatably attached to a first collar 86. The first collar 86 can be slidably attached to the center beam 80.
A second hub 88 can be fixedly attached or rotatably attached to second seal struts 90 and the center beam 80. The second seal struts 90 can slidably connect on the outside or inside of the second seal ring 32 at the free points 82. The second seal struts 90 can be fixedly or rotatably attached to the first seal ring 30 at the fixation points 84. The second seal struts 90 can be fixedly attached or rotatably attached to a second collar 92. The second collar 86 can be slidably attached to the center beam 80. The seal struts 78 and 90, the hubs 76 and 88, and the collars 86 and 92 can be from the same materials as the seal rings 30, 32 and 52.
The seal rings 30 and 32 can be wave-shaped. FIG. 9 illustrates a top view of one embodiment of the wave-shaped seal ring 30, showing a circular shape from above. FIG. 10 illustrates a side view of the wave-shaped seal ring 30 illustrated in FIGS. 8 and 9, showing two periods of smooth oscillation in a seal ring height 94.
FIG. 11 illustrates an embodiment of the seal ring 30 that can have sharp oscillations in the seal ring height 94. Angled seal ring struts 96 can form the seal ring 30 into a zigzag. FIG. 12 illustrates a seal ring 30 that can have a combination of alternating lock zones 98 and angled seal ring struts 96. The lock zones 98 can be substantially parallel to the circumference of the seal ring 30.
FIG. 13 illustrates an embodiment of cross-section A-A (shown in FIG. 1) of the intravascular implant 2 without the seal 20. The anchor 10 can have connectors 4 attached to the arms 14. The second end 8 of each connector 4 can have an integral attachment device 22. The attachment device 22 can be made of a slide 100 and an interference piece 102 defining a catch 104 there between. The slide 100 can have a slide angle 106 from about 90° to about 180°. The slide 100 can also have a slide height 108 from about 0.38 mm (0.015 in.) to about 6.35 mm (0.250 in.), for example about 3.18 mm (0.125 in.). The interference piece 102 can have an interference piece depth 110 from about 0.38 mm (0.015 in.) to about 4.95 mm (0.195 in.). The slide 100 and interference piece 102 can be from the same materials as the seal rings 30, 32 and 52 or seal covers 34 and 48.
FIG. 14 illustrates an embodiment of the intravascular implant 2. The anchor 10 can have a solid ring, and can be fixedly or rotatably attached to about two or more connectors 4. The seal ring 30 can be vertically surrounded by the slides 100 and the interference pieces 102. The seal ring 30 can, therefore, be engaged in the catch 104 and fixedly attached to the connectors 4.
FIG. 15 illustrates an embodiment of the attachment device 22. The attachment device 22 can have first and second slides 100a and 100b, first and second interference pieces 102a and 102b, a catch 104 defined by the slides 100a and 100b and the interference pieces 102a and 102b. The attachment device 22 can also have a rod slot 112 defined between the first slide 100a and second slide 100b, and between the first interference piece 102a and the second interference piece 102b. 
FIG. 16 illustrates an embodiment of cross-section B-B (shown in FIG. 6) of the seal 20. The two turns of the coil 68 can define the catch 104. The coil 68 can have a coil wire diameter 114 from about 0.03 mm (0.001 in.) to about 1.3 mm (0.050 in.), for example about 0.64 mm (0.025 in.).
FIG. 17 illustrates an embodiment of the connector 4 that can be attached to the attachment devices 22, that can be, in turn, attached to the seal 20. The connector 4 can be a flexible wire, coil, rod or combinations thereof and can be hollowed. The connector 4 can also be threaded to rotatably fit the anchor 10 and seal 20 or attachment device 22. The connector can be made from any material listed for the anchor 10.
The attachment devices 22 can be wires, coils, rods or combinations thereof. The connector 4 can also be directly attached to the seal 20. The connector 4 can be attached to the attachment devices 22 at a connector interface 116. The connector interface 116 can have a hub, slider, or collar. The connector interface 116 can be a direct attachment. The connector 4 and attachment device 22 can also be an integral part. The seal 20 and attachment device 22 can also be an integral part.
FIG. 18 illustrates an embodiment of the connector 4 that can be made from a helical connector coil 118. The connector coil 118 can be made from a wire, for example a guidewire, having a diameter from about 0.46 mm (0.018 in.) to about 2.54 mm (0.100 in.). FIG. 19 illustrates an embodiment of the connector 4 that can be made from the connector coil 118 and a connector wire or rod 120. The connector wire or rod 120 can also be made from a wire, for example a guidewire, having a diameter from about 0.46 mm (0.018 in.) to about 2.54 mm (0.100 in.). FIG. 20 illustrates an embodiment of the connector 4 that can have sharp oscillations in connector width. Angled connector struts 124 can form the connector 4 into a zigzag.
FIG. 21 illustrates an embodiment of the intravascular implant 2 that can a longitudinal axis 126. The attachment device 22 can attach the connector 4 to the anchor 10 such that the first end 6 can be substantially on the longitudinal axis 126. The second end 8 can attach to the seal 20 substantially along a radial perimeter of the seal 20.
FIG. 22 illustrates an embodiment of the intravascular implant 2 that can have the attachment device 22 attach the connector 4 to the seal 20 such that the second end 8 can be substantially on the longitudinal axis 126. The first end 6 can attach to the anchor 10 substantially along a radial perimeter of the anchor 10.
FIG. 23 illustrates an embodiment of the intravascular implant 2 that can have multiple connectors 4. The connectors 4 can rotatably or fixedly attach to each other near their centers at joint points 128. Joined pairs of connectors 4 can form x-beams 128. The x-beams 128 can define transverse flow ports 132.
FIG. 24 illustrates an embodiment of the anchor 10 shaped as a helical anchor coil 134 having a first end 136 and a second end 138. The ends 136 and 138 can be dulled, for example by attaching small balls as shown. The seal coil 134 can have from about 1 turn 140 to about 10 turns 140, for example about 4 turns 140. The anchor 10 can also have an anchor width 142 from about 5 mm (0.2 in.) to about 50 mm (2 in.). The anchor 10 can also have an anchor height 144.
FIG. 25 illustrates an embodiment of the anchor 10. The anchor 10 can have the central tip 12, the arms 14, and the leaves 16 as shown and described in FIG. 1. The arms 14 can also extend radially beyond each attachment point 146 of each arm 14 and each leaf 16 to form a diminishing spring force element or tissue mainstay 148. The spring force elements or tissue mainstays 148 on the anchor 10 can be the same material and design as the tissue mainstays 33 on the seal 20, and vice versa. Anchor collar 150 can be slidably mounted to the connector 4 to radially extend or contract the arms 14 and to adjust the height between the anchor 10 and the seal 20 to better place the implant 2 with regard to the transverse vessels, for example the renal arteries, and vascular wall abnormalities. The anchor collar 150 can be fixedly or rotatably attached to arm supports 152. The arm supports 152 can be fixedly or rotatably attached to the arms 14 at support points 154. The arm supports 152 can also be an integral part of the anchor collar 150 and/or the arms 14. The central tip 12, arms 14, leafs 16, mainstays 148, and arm supports 152 can be made from the same materials listed for the seal rings 30, 32 and 52.
FIG. 26 illustrates a top view of an embodiment of anchor 10. Each leaf 16 can have a first leaf end 156 and a second leaf end 158. The first leaf end 156 of one leaf 16 can merge with the second leaf end 158 of the neighboring leaf 16 and the intermediate arm 14 into a cover 160. The cover 160 can be a cylinder with two open ends. The leaf 16, first leaf end 156, second leaf end 158 and cover 160 can be fixedly or rotatably attached. The first leaf end 156 and the second leaf end 158 can terminate within the cover 160. When deployed, the leaf 16 can press against the vascular wall to maintain a substantially circular cross-section of the vessel.
FIG. 27 illustrates an embodiment of the intravascular implant 2 having the arms 14 supported at support points 154 by the connectors 4. The seal 20 can also be radially collapsible and expandable. FIGS. 28 and 29 illustrate embodiments of the intravascular implant 2 that can have a first anchor 10 and a second anchor 162. The second anchor can be fixedly or rotatably attached to connectors 4 at support points 154. The second anchor 162 can also be vertically inverted with respect to the first anchor, as shown in FIG. 29.
Methods Of Manufacture
The tissue mainstays 33, shown in FIG. 2, can be directly attached to the seal rings 30, 32 or 52 by, for example, melting, screwing, gluing, welding or use of an interference fit or pressure fit such as crimping, or combining methods thereof. to join the connector 4 to the seal 20. The tissue mainstays 33 and the seal rings 30, 32 or 52 can be integrated, for example, by die cutting, laser cutting, electrical discharge machining (EDM) or stamping from a single piece or material. The connector interface 116, shown in FIG. 17, can also directly attach to the connector 4 and the seal 20 or be integrated thereto by any method listed for the tissue mainstays 33 and the seal rings 30, 32 or 52. The arm supports 152, shown in FIG. 25, can also be integrated with the anchor collar 150 and/or the arms 14 by any method listed for the tissue mainstays 33 and the seal rings 30, 32 or 52. As shown in FIG. 26, the leaf 16, first leaf end 156, second leaf end 158 and cover 160 can be fixedly or rotatably attached or integrally formed by any by any method listed for the tissue mainstays 33 and the seal rings 30, 32 or 52.
As shown in FIG. 19, the connector coil 118 and connector rod 120 can be attached at the first connector end 6 and the second connector end by methods known to one having ordinary skill in the art.
Integrated parts can be made from pre-formed resilient materials, for example resilient alloys (e.g., Nitinol, ELGILOY®) that are preformed and biased into the post-deployment shape and then compressed into the deployment shape.
Any elongated parts used in the intravascular implant 2 and the second implant 28, for example the tip 12, the arms 14, the leafs 16, the attachment devices 22, the seal rings 30, 32 and 52, the seal coil 68, the connector coil 118, the connector rod 120, the connector strut 124, the anchor coil 134 and the arm supports 152, can be ovalized, or have an oval cross section where necessary, to ease crimping with other parts.
Method Of Use
The intravascular implant 2 can be collapsed or compressed into a deployment configuration to enable minimally invasive implantation into the vasculature of a patient. FIG. 30 illustrates one embodiment of compressing the seal ring 30, as shown in FIG. 4, by applying outward radial forces, as shown by arrows 164, to the thin sections 54 and/or by applying an inward radial force, as shown by arrows 166, to the thick sections 56. Other embodiments can be compressed by applying inward radial forces spread around the circumference of the implant and/or other methods known to those having ordinary skill in the art.
The intravascular implant 2 can be loaded into a delivery catheter 168 by methods known to those having ordinary skill in the art. Because the design of the intravascular implant 2 can separate the anchor 10 from the seal 20, a low profile catheter can be used to deliver the intravascular implant 2. As illustrated in FIG. 31, the delivery catheter 168 can be positioned, as shown by the arrow, at a vascular site 170 using a guidewire (not shown) and an “over-the-wire” delivery method, known to those having ordinary skill in the art. A control line 172 can also extend distally from the implant 2. The control line 172 can include controls used to manipulate any part of the intravascular implant 2 such as rotating the seal 20, expanding or contracting the arms 14, or separating delivery devices from the implant 2, and/or to deliver a substance such as a medication or radiopaque material, and/or to receive signals such as optical or electrical signals. The vascular site 170 can be adjacent to a vascular aneurysm 174, for example an abdominal aortic aneurysm, having a proximal neck 176 and transverse vessels 180, for example renal arteries, proximal to the vascular aneurysm 174.
FIG. 32 illustrates that the catheter 168 can be partially distally retracted, as shown by arrows 182, thereby exposing the arms 14 while retaining the seal 20. Once exposed, the arms 14 can expand radially, as shown by arrows 184. Expansion of the arms 14 can occur due to resilient material expansion or mechanical manipulation. The tissue mainstays 148 can seat in the wall of the vascular site 170 proximal to the transverse vessels 180, preventing the anchor 14 from moving distally. Multiple, independent arms 14 can adjust to the surrounding vasculature geometry to fit as needed for secure attachment to the vascular wall. The distance between the central tip 12 and the seal 20 can be an effective connector length 186. The effective connector length 186 can be adjusted after the tissue mainstays 148 have been seated in the wall of the vascular site 170. The effective connector length 186 can be adjusted by rotating the seal 20, as shown by arrows 188, along a threaded connector 4.
FIG. 33 illustrates that the arms 14 can be contracted, as shown by arrows 190. The anchor 10 can then be easily repositioned, as shown by arrows 192. The intravascular implant 2 can be made from or combined with radiopaque materials and markers to aid the placement, adjustments and repositioning of the intravascular implant 2 and associated parts with the use of an angiogram.
FIG. 34 illustrates an embodiment of the connector 4 and the anchor 10 that can have a contraction line 193 releasably connected to the anchor collar 150. Contraction line 193 can be formed of coaxial hypotubes. Contraction line 193 can also be part of control line 172. The arms 14 can be biased to radially expand or radially contract. FIG. 35 illustrates that the contraction line 193 can be pulled, as shown by arrow 194, which can result in a distal movement of the anchor collar 150, as shown by arrow 196. The distal movement of the anchor collar 150 can cause the arm supports 154 and, in turn, the arms 14 to rotate inward and radially contract, as shown by arrows 198. The above process can be reversed and the arms 14 can be radially expanded. The contraction line can be separated from the anchor collar 150 when placement of the anchor 10 is finalized.
FIG. 36 illustrates an embodiment of the connector 4 and the anchor 10 that can have a fixed hub 200 that is fixedly held in space, for example by the seal 20, the delivery catheter 168 and/or the control line 172, distal to the anchor collar 150. The fixed hub 200 can also be slidably connected to the connector 4. FIG. 37 illustrates that the connector 4 can be pulled distally, as shown by arrow 202, which can cause the anchor collar 150 to butt against the fixed hub 200 and be forced proximally with respect to the connector 4, as shown by arrow 204. The proximal movement of the anchor collar 150 can cause outward rotation and radial expansion of the arm supports 154 and, in turn, the arms 14, as shown by arrows 206. The above process can be reversed and the arms 14 can be radially contracted. The arms 14 can be locked into place by methods known to those having ordinary skill in the art.
FIG. 38 illustrates that the catheter 168 can be retracted distally of the seal 20, as shown by arrows 208. Retracting the catheter 168 can expose the seal 20, allowing the seal 20 to radially expand, as shown by arrows 210. The seal 20 can be placed to seat in the proximal neck 176. When fully deployed, the intravascular implant 2 can have an open-walled structure, and can therefore be placed adjacent to the transverse vessels 180 without interfering with the flow through the transverse vessels 180.
FIG. 39 illustrates the intravascular implant 2 that can be implanted in the vascular site 170. The distal end 26 can be attached to a second implant 28, for example a vascular graft such as an abdominal aortic aneurysm graft, for example a gel weave aortic graft. The second implant 28 can have two branching legs 212.
FIG. 40 illustrates a cross-section of an embodiment of the attachment device 22 and second end 8 of the seal 4. The seal ring 30 can be proximal to the slides 100. The seal cover 34 or the second implant 28 can extend from the seal ring 30. FIG. 41 illustrates pulling the seal ring 30 along the slides 100, as shown by arrows 214. Movement of the seal ring 30 along the slides 100 can cause the seal ring to radially contract, as shown by arrows 216. Once the seal ring 30 is distally clear of the slides 100, the seal ring 30 can radially expand, as shown by arrows 218, and seat into the catch 104. Once in the catch 104, the seal ring 30 can be held vertically in place by the distal side of the slide 100 and the proximal side of the interference piece 102.
As illustrated in FIG. 43, the second implant 28 can be attached to the seal ring 30 at the proximal end of the second implant 28. The seal ring 30 can be releasably attached to deployment rods 220.
As illustrated in FIG. 44, the deployment rods 220 can be used to position the seal ring 30 proximal to the attachment device 22 and so that the deployment rods 220 align into the rod slots 112. (The second implant 28 is not shown in FIG. 44 for clarity). The deployment rods 220 can be pulled distally, as shown by arrow 222, thereby moving the seal ring 30 distally. As illustrated in FIG. 45, the seal ring 30 can then seat into the catch 104. The deployment rods 220 can be detached from the seal ring 30 and removed from the vascular site 170. The control line 172 can be removed from the vascular site 170 whenever removal is deemed appropriate during the implantation procedure.
FIG. 46 illustrates an embodiment of the intravascular implant 2 deployed at a vascular site 170. The vascular site 170 can have a severely tortuous region over which the implant 2 is placed. The flexibility of the connector 4 compensates for the contortion in the vascular site, enabling the arms 14 to intersect the wall of the vascular site 170 at a substantially perpendicular angle, and enabling the seal 20 to seat into the proximal neck 176 to open into the at a substantially parallel angle to the body of the second implant 28. Stress and fractures in the intravascular implant 2 and in the tissue at the vascular site 170 can be minimized due to the anchor 10 being mechanically insulated from the seal 20 by use of the connector 4. Additionally, stresses can be reduced because the tissue in the vascular site 170 adjacent to the anchor 10 does not need to seal, and the tissue in the vascular site 170 adjacent to the seal 20 does not need to anchor. Additional intravascular implants 2, as shown, can be deployed at the distal ends 224 of the second implant 2, for example in the iliac arteries, to additionally secure the second implant 2.
The arms 14 and/or the seal 20 can apply chronic stress to the adjacent tissue in the vascular site 170 causing a controlled migration of the arms 14 and/or seal 20 into the wall of the vascular site 170 to a specified depth predetermined by the tissue mainstays 33 and/or 148. The predetermined depth can be the length of the tissue mainstay 33 and/or 148, or a force exerted by the tissue mainstay 33 and/or 148. The controlled migration is then halted by either a distribution of force along the greater surface area between the tissue mainstay 33 and/or 148 and the wall of the vascular site 170 or the diminishing force on the same surface area once the radially central end (with respect to the anchor 10) of the tissue mainstay 33 and/or 148 has reached the wall of the vascular site 170, or a combination of both. Tissue can then ingrow around the tissue mainstay 33 and/or 148 providing a biologic seal or anchor so that the integrity of the seal or anchor is not purely mechanical.
It is apparent to one having ordinary skill in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements shown with any embodiment are exemplary for the specific embodiment and can be used on other embodiments within this disclosure.

## Claims

1. A device for treating an aneurysm having a longitudinal axis, the device comprising:
a vascular graft comprising a tubular channel having a first end and a second end, wherein the tubular channel is bifurcated at a bifurcated portion at the second end;
an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to a circumference of the vascular graft, wherein the expandable anchor comprises a first anchor portion having a first transverse diameter and a second anchor portion having a second transverse diameter, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse diameter is greater than the first transverse diameter, and wherein the second anchor portion is a terminal end of the expandable anchor; and
a seal on the vascular graft, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and comprises a seal volume fillable by a fluid,
wherein the seal comprises a first seal portion and a second seal portion,
wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,
wherein the first seal portion has a first portion radius measured from the longitudinal axis of the device to a furthest point on an exterior surface of the first seal portion,
wherein the second seal portion has a second portion radius measured from the longitudinal axis of the device to the furthest point on an exterior surface of the second seal portion,
wherein the first length of material has a first length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the first length of material,
wherein the second length of material has a second length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the second length of material,
wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and
wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

2. The device of claim 1, wherein the first seal portion and the second seal portion are in fluid communication.

3. The device of claim 1, wherein the vascular graft is connected to the expandable anchor by connectors and wherein at least two of the connectors are joined in an x-shaped pattern.

4. The device of claim 1, wherein the seal comprises at least one of polytetrafluoroethylene (PTFE), polyester, polyurethane, nylon, and silicone.

5. The device of claim 1, wherein the seal is configured to assist in holding the vascular graft in place within a blood vessel of a patient.

6. The device of claim 1, wherein the fluid is a biocompatible fluid.

7. The device of claim 1, wherein the vascular graft is configured to be placed across an abdominal aortic aneurysm.

8. The device of claim 1, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the circumference of the vascular graft.

9. The device of claim 1, wherein the seal has a gap in a circumference of the seal.

10. The device of claim 1, wherein the seal forms a c-ring.

11. The device of claim 1, wherein the terminal end of the second anchor portion is configured to contact tissue.

12. The device of claim 1, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.

13. A device for treating an aneurysm having a longitudinal axis, the device comprising:
a vascular graft comprising a tubular channel having a first end and a second end;
an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to the longitudinal axis, wherein the expandable anchor comprises a first anchor portion having a first transverse diameter and a second anchor portion having a second transverse diameter, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse diameter is greater than the first transverse diameter, and wherein the second anchor portion is a terminal end of the expandable anchor; and
a seal on the vascular graft, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and comprises a seal volume fillable by a fluid,
wherein the seal comprises a first seal portion and a second seal portion,
wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,
wherein the first seal portion has a first portion radius measured from the longitudinal axis of the device to a furthest point on an exterior surface of the first seal portion,
wherein the second seal portion has a second portion radius measured from the longitudinal axis of the device to the furthest point on an exterior surface of the second seal portion,
wherein the first length of material has a first length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the first length of material,
wherein the second length of material has a second length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the second length of material,
wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and
wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

14. The device of claim 13, wherein the seal comprises at least one of polytetrafluoroethylene (PTFE), polyester, polyurethane, nylon, and silicone.

15. The device of claim 13, wherein the seal is configured to assist in holding the vascular graft in place within a blood vessel of a patient.

16. The device of claim 13, wherein the fluid is a biocompatible fluid.

17. The device of claim 13, wherein the vascular graft is configured to be placed across an abdominal aortic aneurysm.

18. The device of claim 13, further comprising at least two connectors connecting the expandable anchor to the vascular graft, wherein the two connectors are joined in an x-shaped pattern.

19. The device of claim 13, further comprising a seal cover covering the seal.

20. The device of claim 13, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the longitudinal axis.

21. The device of claim 13, wherein the seal has a gap in a circumference of the seal.

22. The device of claim 13, wherein the seal forms a c-ring.

23. The device of claim 13, wherein the terminal end of the second anchor portion is configured to contact tissue.

24. The device of claim 13, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.

25. A method of treating an aneurysm, the method comprising:
positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel of a patient, wherein the tubular channel is bifurcated at a bifurcated portion at the second end;
securing the vascular graft in place with an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to the longitudinal axis, and wherein a leaf portion partially covers at least two of the longitudinal anchor arms;
expanding the expandable anchor, wherein the expandable anchor comprises a first anchor portion having a first transverse width and a second anchor portion having a second transverse width, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse width is greater than the first transverse width when the expandable anchor is expanded, and wherein the second anchor portion is a terminal end of the expandable anchor; and
filling a seal on the vascular graft with a fluid, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and the fluid fills a seal volume,
wherein the seal comprises a first seal portion and a second seal portion,
wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,
wherein the first seal portion has a first portion radius measured from the longitudinal axis to a furthest point on an exterior surface of the first seal portion,
wherein the second seal portion has a second portion radius measured from the longitudinal axis to the furthest point on an exterior surface of the second seal portion,
wherein the first length of material has a first length of material radius measured from the longitudinal axis to the furthest point along an exterior surface of the first length of material,
wherein the second length of material has a second length of material radius measured from the longitudinal axis to the furthest point along an exterior surface of the second length of material,
wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and
wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

26. The method of claim 25, further comprising positioning the vascular graft across an abdominal aortic aneurysm.

27. The method of claim 25, wherein the vascular graft is connected to the expandable anchor by connectors and wherein at least two of the connectors are joined in an x-shaped pattern.

28. The device of claim 25, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the longitudinal axis.

29. The device of claim 25, wherein the seal has a gap in a circumference of the seal.

30. The device of claim 25, wherein the seal forms a c-ring.

31. The device of claim 25, wherein the terminal end of the second anchor portion is configured to contact tissue.

32. The device of claim 25, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.