This invention relates generally to endoluminal devices, and more particularly concerns implants such as stents and grafts for placement in an area of a body lumen that has been weakened by damage or disease, such as by aneurysms of the abdominal aorta. In particular, the present invention relates to such devices having barbs that engage the body lumen upon or after deployment of the device. The invention also relates to methods for using such barbed endoluminal devices.
A stent is an elongated device used to support an intraluminal wall. In the case of a stenosis, a stent provides an unobstructed conduit through a body lumen in the area of the stenosis. Such a stent may also have a prosthetic graft layer of fabric or covering lining the inside and/or outside thereof. A covered stent is commonly referred to in the art as an intraluminal prosthesis, an endoluminal or endovascular graft (EVG), an endoluminal device, or a stent-graft. As used herein, the term “implant” shall mean any covered stent or uncovered stent or other medical device suitable for implantation in a body and for use in connection with the present invention.
A stent-graft may be used, for example, to treat a vascular aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of rupture. Typically, a stent is implanted in a blood vessel at the site of a stenosis or aneurysm endoluminally, i.e. by so-called “minimally invasive techniques” in which the stent, restrained in a radially compressed configuration by a sheath or catheter, is delivered by a stent delivery system or “introducer” to the site where it is required. The introducer may enter the body from an access location outside the body, such as through the patient's skin, or by a “cut down” technique in which the entry blood vessel is exposed by minor surgical means. The term “proximal” as used herein refers to portions of the stent or delivery system relatively closer to the end outside of the body, whereas the term “distal” is used to refer to portions relatively closer to the end inside the body.
When the introducer has been threaded into the body lumen to the stent deployment location, the introducer is manipulated to cause the stent to be ejected from the surrounding sheath or catheter in which it is restrained (or alternatively the surrounding sheath or catheter is retracted from the stent), whereupon the stent expands to a predetermined diameter at the deployment location, and the introducer is withdrawn. Stent expansion may be effected by spring elasticity, balloon expansion, or by the self-expansion of a thermally or stress-induced return of a memory material to a pre-conditioned expanded configuration.
Among the many applications for stent-grafts is that of deployment in lumen for repair of aneurysms, such as abdominal aortic aneurysms (AAA). An AAA is an area of increased aortic diameter that generally extends from just below the renal arteries to the aortic bifurcation. AAA generally results from deterioration of the arterial wall, causing a decrease in the structural and elastic properties of the artery. In addition to a loss of elasticity, this deterioration also causes a slow and continuous dilation of the lumen.
The standard surgical repair of AAA is an extensive and invasive procedure typically requiring a weeklong hospital stay and an extended recovery period. To avoid the complications of the surgical procedure, practitioners commonly resort to a minimally invasive procedure using endoluminal stent-grafts to reinforce the weakened vessel wall, as mentioned above. At the site of the aneurysm, the practitioner deploys the stent-graft, anchoring it above and below the aneurysm to relatively healthy tissue. The anchored stent-graft diverts blood flow away from the weakened arterial wall, minimizing the exposure of the aneurysm to high pressure.
Intraluminal stents for repairing a damaged or diseased artery or to be used in conjunction with a graft for delivery to an area of a body lumen that has been weakened by disease or damaged, such as an aneurysm of the abdominal aorta, are well established in the art of medical science. The use and description of such intraluminal stents are set forth in U.S. Pat. Nos. 5,681,346; 5,800,526; and 5,843,164. These references are each incorporated in their entirety as part of this specification. One aspect of the use of such intraluminal stents are the means by which such devices are secured within the intraluminal body in which they are to be deployed. This is important because subsequent movement of the stent (or “migration”) could cause the aneurysm to become exposed to blood pressure. In particular, if the device migrates proximally over time, a leak at the distal end of the device (i.e., a “type I endoleak”) could cause blood to undesirably flow to the aneurysm.
Stents with fixed barbs have been used to engage the vessel wall as the deployment sheath is pulled back from the stent. However, such stents with fixed integrated barbs are difficult to load into the catheter deployment system. Fixed barbs are not flush to the perimeter of the stent and therefore have a tendency to prevent the stent from being loaded or to cause the stent to become lodged inside the catheter during loading. Moreover, catheter deployment systems used to deploy stents with barbs are commonly scratched during the deployment of the stent. Scratching of the catheter deployment system can cause plastic particulate from the catheter deployment system to enter the bloodstream, potentially forming an embolus.
Accordingly, it can be seen that while the art has advanced the use of barbs to minimize migration of a deployed stent-graft, such barbs bring with them additional or new problems such as damaging the wall of the vessel or hindering the placement of the stent and body graft. While the art has attempted to address such problems, there still remains a need for improvement in the art. Such improvement is critical inasmuch as scratching of the deployment system can cause plastic or other particulate from the deployment system to enter the blood stream, potentially forming an embolus.
In view of its purposes and the needs of the prior art, the present invention provides an endoluminal device comprising an implant and a barb or barb assembly. According to a first embodiment, a device for implantation in a body lumen comprises an implant and at least one barb assembly. The implant may be a stent having a radially compressed configuration and a radially expanded configuration and comprising at least one filament which pivots as the stent moves between the radially compressed configuration and the radially expanded configuration. The barb assembly comprises: (i) a first portion attached to the stent, (ii) a bend, and (iii) a second portion, disposed opposite the first portion relative to the bend and having a bearing surface. The second portion is adapted to protrude radially inward when the stent is in the radially compressed configuration. The filament radially contacts and imparts a radially outward force against the bearing surface as the stent moves from the radially compressed configuration to the radially expanded configuration to cause the second portion to protrude radially outward (or “flip” outwardly) when the stent is in its radially expanded configuration. A method for implanting an endoluminal device according to this first embodiment in a body lumen comprises the steps of compressing the endoluminal device into a radially compressed configuration and retaining the device in an introducer; introducing the introducer into the body lumen to a deployment location; and deploying the endoluminal device from the introducer and into the body lumen.
According to a second embodiment of the present invention, a device for implantation in a body lumen from a proximal access location comprises an implant and at least one barb. The implant may be a stent having a radially compressed configuration for insertion into a sheath and comprising at least one filament. The barb comprises (i) a base segment attached to the filament and (b) a curved segment extending from the base segment and terminating in a point. The curved segment is curved proximally and radially inwardly but not to such an extent so as to extend radially within the periphery defined by the stent. A method for implanting an endoluminal device according to this embodiment in a body lumen comprises the steps of compressing the endoluminal device into a radially compressed configuration and retaining the device in an introducer; introducing the introducer into the body lumen to a deployment location; deploying the endoluminal device from the introducer and into the body lumen; and twisting the implant between 1 and 15 degrees to cause the curved segment to engage the body lumen.
According to a third embodiment of the present invention, a device for implantation in a body lumen from a proximal access location comprises an implant and at least one barb assembly. The implant may be a stent having a radially compressed configuration and a radially expanded configuration and defining a plurality of cells each having a cell height. The barb assembly comprises: (i) a wire extending from the top of a cell to the bottom of a cell and having a length greater than the cell height and a substantially uniform cross-sectional area; and (ii) a hook attached to the wire and extending radially outward. The wire is formed to arc radially inwardly when the stent is in its radially compressed configuration and is capable of being arced radially outward when the stent is in its radially expanded configuration. A method for implanting an endoluminal device according to this embodiment in a body lumen comprises the steps of compressing the endoluminal device into a radially compressed configuration and retaining the device in an introducer; introducing the introducer into the body lumen to a deployment location; deploying the endoluminal device from the introducer and into the body lumen; and imparting a radially outward force against the barb assembly to cause the barb assembly to arc radially outwardly and cause the hook to engage the body lumen.
The foregoing general description and subsequent detailed description are representative, not restrictive, of the invention.
The invention is best understood when the following detailed description is read with reference to the attached drawing, in which:
a depicts a perspective view of a portion of the device shown in
b depicts a perspective view of a portion of the device shown in
a depicts view of a portion of an endoluminal device according to a second embodiment of the present invention;
b depicts a top view of the device shown in
c depicts a top view of the device shown in
a depicts a view of a portion of an endoluminal device according to a third embodiment of the present invention;
b depicts a side view along the lines A-A of a portion of the device shown in
c depicts a side view along the lines A-A of a portion of the device shown in
The invention will next be illustrated with reference to the figures wherein the same numbers indicate similar elements in all figures. Such figures are intended to be illustrative rather than limiting and are included herewith to facilitate the explanation of the apparatus of the present invention.
The present invention is directed to devices for implantation in a body lumen. Such devices include an endoluminal device used to treat an Abdominal Aortic Aneurysm (AAA). Such an endoluminal device typically comprises a stent having a graft extending along a portion of the stent. Devices according to the present invention may also include other implants which have a stent-like structure and, after implantation of which, migration is sought to be minimized. The body lumen in which a device of the present invention may by implanted include any body lumen in which such devices are typically implanted to perform a wide range of medical functions. In the AAA application, the body lumen is at least one artery, such as the aorta or the aorta and one or both iliac arteries.
The device of the present invention uses an implant and a barb or barb assembly. The implant used in the present invention can be any number of suitable stents known in the art. A number of suitable stent configurations are described and referenced in co-pending U.S. patent application Ser. No. 09/442,165, entitled MULTI-SECTION FILAMENTARY ENDOLUMINAL STENT, assigned to the assignee of this application and incorporated herein by reference. The stent may be wound, braided, or made from a laser-cut tube. The stent may be self-expanding or may be capable of expansion by an external force, such as a balloon. The material of the stents may also be any suitable material typically used for such applications, such as nitinol. In the embodiments discussed, the stent has a braided section 102 and a wound section 104, as shown for example in
The device shown in
Self-deploying barb assembly 105 is pre-fabricated and made of a biocompatible wire, such as nitinol or a material compatible with the biocompatible material of stent 100. In this particular example, self-deploying barb assembly 105 is in the area of intersection 120, which is in a row of stent 100 between braided section 102 and wound section 104. More specifically, barb assembly 105, including bend 120, is disposed adjacent intersection 120. The present invention is not limited to this configuration. Self-deploying barb assemblies 105 may also be fixed to vertical cell segments 125 or to another row within braided section 102. Stent 100 may include a plurality of self-deploying barb assemblies 105 attached along the perimeter of stent 100 and having variable dimensions and geometry, as long as both stent 100 and self-deploying barb assemblies 105 function within a medically acceptable tolerance.
In some embodiments, the device may also include a graft 130 as shown in
a shows a three-dimensional view of a segment of the device of
b is a three-dimensional view of a segment of the device of
As can be seen when comparing
As is known, the angle of some intersections of certain types of stents changes as the stent moves from a radially compressed configuration to a radially expanded configuration. This is true for braided stents or braided portions of stents, such as braided portion 102, in which angle .alpha. is shown in
A method for implanting an endoluminal device in a body lumen involves first compressing the endoluminal device into a radially compressed configuration and retaining it in an introducer. Such an introducer may be a delivery catheter as are well known in the art, such as those described in U.S. patent application Ser. No. 09/573,273, entitled STENT DELIVERY SYSTEM FOR PREVENTION OF KINKING, AND METHOD OF LOADING AND USING SAME, assigned to the assignee of this application and incorporated herein by reference. Next, the introducer is introduced or threaded into the body lumen via a vascular access site to a deployment location, such as by using a well-known percutaneous cut-down technique referred to above. Examples of the vascular access site include the femoral artery. The access site may be surgically exposed and punctured with, for example, an 18-gauge needle. Then, the device is deployed from the introducer and into the body lumen. This is typically done by first aligning the distal end of the device, then retracting an outer sheath of the introducer. After or upon deployment, the endoluminal device expands to form a radial expanded portion and the at least one filament radially contacts the second portion and imparts a radially outward force against the bearing surface as the implant (e.g., stent) moves from its radially compressed configuration to its radially expanded configuration to cause the second portion to protrude radially outward and engage the body lumen when the stent is in its radially expanded configuration. In the event that the stent is self-expanding, the radial expansion of the stent is caused by the removal of the stent from the introducer. On the other hand, if the stent is not self-expanding, the radial expansion of the stent is caused by expanding a balloon (or some other external source of radially outward force) from within the stent.
According to another embodiment of the present invention,
Barb 405 is a biocompatible material, such as nitinol or a material compatible with the biocompatible material of stent 400. Barb 405 is preferably welded at the base of vertical segment 410 where first filament 415 and second filament 420 intersect. Barb 405 is corkscrewed to the longitudinal axis of stent 400. The degree of skewness can range from a small degree to a large degree. The degree of skewness, of course, should be sufficient to allow the barb to hold the stent in place, without causing any damage to the introducer. Preferably, the longitudinal axis of base segment 407 is at least somewhat parallel, more preferably about parallel, to a line intersecting the longitudinal axis at a right angle (90 degrees). When the proximal end of stent 400 is deployed, stent 400 may be rotated to implant barbs 405 into the vessel wall, thereby securing the vessel wall to the stent graft. Barbs 405 are preferably configured such that only a slight rotation of the catheter (e.g., about 15.degree. or less) is required to twist the barbs into the vessel wall. As in the first embodiment, the device may further comprise a graft 430 which is affixed to stent 400 remote from barb 405.
b shows filamentary stent 400 with a plurality of corkscrewed barbs 405. Barbs 405 are pointing in an outward direction, i.e., as they would point in a deployed configuration. This is after the device has been deployed and twisted in the body lumen to cause an increase in angle .beta.
c shows the compressed filamentary stent 400 with a plurality of corkscrewed barbs 405. When stent 400 is compressed for loading into the stent deployment catheter, barbs 405 are aligned so that the points of barbs 405 do not scrape the inner surface of the outer sheath. Barbs 405 are preferably just slightly curved, as shown in
A method to deploy a stent according to this embodiment of the invention again involves compressing the endoluminal device into a radially compressed configuration and retaining the device in an introducer; introducing the introducer into the body lumen to a deployment location; and deploying the endoluminal device from the introducer and into the body lumen. This method also involves twisting the stent between 1 and 15 degrees to cause the curved segment to engage the body lumen. This twisting or rotation involves rotation in an engaging direction. Similarly, if it is desired to disengage the implant, then rotation in the opposite direction would disengage the engagement means.
According to another embodiment of the present invention,
The mechanism can involve using stent wires (or ribbon) such that there are two support wires of the same length, on either side of a third wire of a longer length than the supports. As a result the longer wire is bowed and can be placed on the inner or outer side of the stent by pushing on the bowed wire. An illustrative example of such apparatus is depicted in the
The hook(s)/barb(s) can be cut, etched, or attached to the longer wire in any way (facing up, down or both). The barbs can be set on the inner side of the stent for loading and deployment. Then, to deploy the barbs to the outer side post implantation of the device a balloon can be inflated or an inner member dilator/sheath on the delivery system can be advanced in the barb area to push or set the barbs to the outer side of the stent.
A method to deploy a device according to this embodiment of the invention again involves compressing the endoluminal device into a radially compressed configuration and retaining the device in an introducer; introducing the introducer into the body lumen to a deployment location; and deploying the endoluminal device from the introducer and into the body lumen. This method also involves imparting a radially outward force against the barb assembly to cause the barb assembly to arc radially outwardly and cause the hook to engage the body lumen.
In connection with any of the embodiments discussed herein, radiopaque markers may be used in the construction of the attachment means. Such markers assist in deploying, moving or removing the stent since the status of the barb can be determined. Preferably, radiopaque material can be used in the construction of the engagement means, thereby permitting the artisan to further reduce the risk of damage.
In another embodiment of the present invention, the barbs are supported such that during loading into the catheter, in the fully loaded state and during deployment there is no contact between the barbs and the catheter wall. Then, either once the barbed area is exposed or the entire stent-graft system is deployed, the barbs are deployed into place by means such as inflating a balloon or advancing a dilator to push the barbs out into place.
Although illustrated and described herein with reference to certain specific embodiments, the present invention is nevertheless not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention.
This application is a divisional of U.S. application Ser. No. 10/153,351, filed May 22, 2002, the contents of which are incorporated herein by reference in its entirety.
Number | Date | Country | |
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Parent | 10153351 | May 2002 | US |
Child | 14099605 | US |