INTRAVASCULAR IMPLANTS AND METHODS OF USING THE SAME
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.
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This application is a continuation of U.S. patent application Ser. No. 15/670,797 filed Aug. 7, 2017, which is a continuation of U.S. patent application Ser. No. 15/284,381 filed Oct. 3, 2016 (now U.S. Pat. No. 9,744,026), which is a continuation of U.S. patent application Ser. No. 13/666,756 filed Nov. 1, 2012 (now U.S. Pat. No. 9,615,912), which is a continuation of U.S. patent application Ser. No. 11/351,423 filed Feb. 10, 2006 (now abandoned), which is a continuation of U.S. patent application Ser. No. 10/778,870 filed Feb. 12, 2004 (now abandoned), which claims the benefit of priority to U.S. Provisional Application No. 60/447,056 filed Feb. 12, 2003, the contents of all which are incorporated herein by reference in their entireties for all purposes.
BACKGROUND OF THE INVENTION 1. Field of the InventionThe 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 ArtAn 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 INVENTIONOne 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.
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.
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.).
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.
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.
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.
The tissue mainstays 33, shown in
As shown in
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 UseThe intravascular implant 2 can be collapsed or compressed into a deployment configuration to enable minimally invasive implantation into the vasculature of a patient.
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
As illustrated in
As illustrated in
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. (canceled)
2. A device for treating an aneurysm having a device longitudinal axis, the device comprising:
- a bifurcated vascular graft comprising a main branch, a first leg, and a second leg, wherein the second leg is longer than the first leg, wherein the main branch is positionable across the aneurysm, and wherein the first leg and the second leg are positionable across the aneurysm;
- a fillable seal comprising a first port, a second port, a third port, and a fourth port, wherein the first port and the second port are closer to a fillable seal proximal end than to a fillable seal distal end, wherein the third port and the fourth port are closer to the fillable seal distal end than to the fillable seal proximal end, wherein the first port is opposite the third port, wherein the second port is opposite the fourth port, wherein the first port and the third port are on a fillable seal first side, wherein the second port and the fourth port are on a fillable seal second side, wherein the fillable seal first side is opposite the fillable seal second side, wherein the third port is closer to the first leg than the first port, the second port, and the fourth port, and wherein the fourth port is closer to the second leg than the first port, the second, port, and the third port;
- first anchor arms and second anchor arms, wherein the first anchor arms are closer to a device proximal terminal end than the second anchor arms, wherein the device comprises a contracted configuration and an expanded configuration, and wherein when the device is in the contracted configuration, the first anchor arms and the second anchor arms are moveable away from the device longitudinal axis;
- connectors between the fillable seal and the first anchor arms, wherein the first anchor arms and the second anchor arms extend from the connectors; and
- flow ports between the fillable seal and the first anchor arms, wherein the flow ports are between adjacent connectors,
- wherein when the device is in a fully deployed configuration, the main branch extends across the aneurysm, the first leg extends across the aneurysm, and the second leg extends across the aneurysm,
- wherein when the device is in the fully deployed configuration, the first anchor arms, the second anchor arms, the connectors, the flow ports, and the fillable seal are proximal the aneurysm, and
- wherein when the device is in the fully deployed configuration, the first anchor arms, the second anchor arms, the connectors, and the flow ports are proximal the fillable seal.
3. The device of claim 2, wherein when the device is in the fully deployed configuration, the first port and the second port are the same distance from the fillable seal proximal end, and wherein when the device is in the fully deployed configuration, the first port and the second port are the same distance from the fillable seal distal end.
4. The device of claim 3, wherein when the device is in the fully deployed configuration, the third port and the fourth port are the same distance from the fillable seal proximal end, and wherein when the device is in the fully deployed configuration, the third port and the fourth port are the same distance from the fillable seal distal end.
5. The device of claim 2, wherein a fluid is flowable through the first port, the second port, the third port, and the fourth port.
6. The device of claim 2, wherein a fluid is simultaneously flowable through the first port, the second port, the third port, and the fourth port.
7. The device of claim 2, wherein an outermost perimeter of the fillable seal is farther from the device longitudinal axis than the first port, the second port, the third port, and the fourth port.
8. The device of claim 2, wherein the fillable seal further comprises a channel, wherein the first port and the third port are farther from the device longitudinal axis than the channel, wherein the third port and the fourth port are farther from the device longitudinal axis than the channel, wherein the channel is between the first port and the second port, and wherein the channel is between the third port and the forth port.
9. The device of claim 2, wherein when the device is in the fully deployed configuration, the first anchor arms and the second anchor arms are proximal the renal arteries and the fillable seal is distal the renal arteries.
10. The device of claim 2, wherein the fillable seal is a first fillable seal, wherein the device further comprises a second fillable seal and a third fillable seal, wherein the first fillable seal is integrated with the main branch, wherein the second fillable seal is integrated with the first leg, and wherein the third fillable seal is integrated with the second leg.
11. The device of claim 10, wherein the second fillable seal has a c-shape, and wherein the third fillable seal has a c-shape.
12. The device of claim 2, further comprising a first leg anchor and a second leg anchor, wherein the first leg anchor extends distally away from a first leg distal terminal end, and wherein the second leg anchor extends distally away from a second leg distal terminal end.
13. A device for treating an aneurysm having a device longitudinal axis, the device comprising:
- a bifurcated vascular graft comprising a main branch, a first leg, and a second leg, wherein the main branch is positionable across the aneurysm, and wherein a first leg distal end and a second leg distal end are positionable across the aneurysm;
- a fillable seal comprising a first channel, a second channel, and a third channel, wherein the first channel is on a fillable seal first side, wherein the second channel is on a fillable seal second side, wherein the third channel is on the fillable seal first side and on the fillable seal second side, wherein the fillable seal first side is opposite the fillable seal second side, wherein the first channel is farther from the device longitudinal axis than the third channel, wherein the second channel is farther from the device longitudinal axis than the third channel, wherein the third channel is between first channel and the second channel, and wherein the third channel extends through a longitudinal center of the fillable seal;
- first anchor arms and second anchor arms, wherein the first anchor arms are farther from the fillable seal than the second anchor arms, wherein the device comprises a contracted configuration and an expanded configuration, and wherein when the device is in the contracted configuration, the first anchor arms and the second anchor arms are moveable away from the device longitudinal axis;
- connectors between the fillable seal and the first anchor arms, wherein the first anchor arms and the second anchor arms extend from the connectors; and
- flow ports between the fillable seal and the first anchor arms, wherein the flow ports are between adjacent connectors,
- wherein when the device is in a fully deployed configuration, the main branch extends across the aneurysm, a first leg distal end is in the aneurysm, and a second leg distal is in the aneurysm,
- wherein when the device is in the fully deployed configuration, the first anchor arms, the second anchor arms, the connectors, the flow ports, and the fillable seal are proximal the aneurysm, and
- wherein when the device is in the fully deployed configuration, the first anchor arms, the second anchor arms, the connectors, and the flow ports are proximal the fillable seal.
14. The device of claim 13, wherein the first channel has a cylindrical shape, wherein the second channel has a cylindrical shape, and wherein when the device is in the fully deployed configuration, the first anchor arms and the second anchor arms are proximal the renal arteries and the fillable seal is distal the renal arteries.
15. The device of claim 13, wherein a fluid is flowable through the first channel and the second channel.
16. The device of claim 13, wherein a fluid is simultaneously flowable through the first channel and the second channel.
17. The device of claim 13, wherein the first channel extends to the first leg, and wherein the second channel extends to the second leg.
18. The device of claim 13, wherein when the device is in a partially deployed configuration, fluid is in the first channel and in the second channel, wherein the device further comprises a first leg anchor and a second leg anchor, wherein the first leg anchor extends distally away from a first leg distal terminal end, and wherein the second leg anchor extends distally away from a second leg distal terminal end.
19. The device of claim 18, wherein the fillable seal is a first fillable seal, wherein the device further comprises a second fillable seal and a third fillable seal, wherein the first fillable seal is integrated with the main branch, wherein the second fillable seal is integrated with the first leg, wherein the third fillable seal is integrated with the second leg, wherein the first leg anchor is positionable in a channel that extends through the second fillable seal, and wherein the second leg anchor is positionable in a channel that extends through the third fillable seal.
20. A device for treating an aneurysm having a device longitudinal axis, the device comprising:
- a bifurcated vascular graft comprising a main branch, a first leg, and a second leg, wherein the second leg is longer than the first leg, wherein the main branch is positionable across the aneurysm, and wherein the first leg and the second leg are positionable across the aneurysm;
- a fillable seal comprising a first channel and a second channel, wherein the first leg extends from the first channel, and wherein the second leg extends from the second channel;
- a first anchor arm, a second anchor arm, a third anchor arm, and a fourth anchor arm, wherein the first anchor arm and the second anchor arm are closer to a device proximal terminal end than the third anchor arm and the fourth anchor arm, wherein the device comprises a contracted configuration and an expanded configuration, wherein when the device is in the contracted configuration, the first anchor arm and the third anchor arm are moveable away from the device longitudinal axis in a first direction and the second anchor arm and the forth anchor arm are moveable away from the device longitudinal axis in a second direction opposite the first direction, and wherein when the device is in the expanded configuration, the first anchor arm and the third anchor arm are opposite the second anchor arm and the fourth anchor arm;
- a first connector and a second connector, wherein the first anchor arm and the third anchor arm extend from the first connector, and wherein the second anchor arm and the fourth anchor arm extend from the second connector; and
- flow ports between the fillable seal and the first anchor arm and the second anchor arm,
- wherein when the device is in a fully deployed configuration, the main branch extends across the aneurysm, a first leg distal end is in the aneurysm, and a second leg distal is in the aneurysm,
- wherein when the device is in the fully deployed configuration, the first anchor arm, the second anchor arm, the third anchor arm, the fourth anchor arm, the first connector, the second connector, the flow ports, and the fillable seal are proximal the aneurysm, and
- wherein when the device is in the fully deployed configuration, the first anchor arm, the second anchor arm, the third anchor arm, the fourth anchor arm, the first connector, the second connector, and the flow ports are proximal the fillable seal.
21. The device of claim 20, wherein the first channel has a cylindrical shape, wherein the second channel has a cylindrical shape, wherein the first channel and the second channel are offset from the device longitudinal axis, wherein a fluid is simultaneously flowable through the first channel and the second channel, wherein when the device is in the fully deployed configuration, the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm are proximal the renal arteries and the fillable seal is distal the renal arteries, wherein the device further comprises a first leg anchor and a second leg anchor, wherein the first leg anchor extends distally away from a first leg distal terminal end, and wherein the second leg anchor extends distally away from a second leg distal terminal end.
Type: Application
Filed: Feb 22, 2021
Publication Date: Aug 12, 2021
Applicant: (Los Altos, CA)
Inventor: Thomas J. Fogarty (Los Altos, CA)
Application Number: 17/181,783