BACKGROUND OF THE INVENTION1. Field of the Invention
The present invention relates to an intra-vascular device and method. More particularly, the present invention relates to a device used to treat aneurysms where a branch connection from a main stent graft crosses the ostium of a branch vessel.
2. Description of Related Art
A conventional main stent graft typically includes a radially expandable reinforcement structure, formed from a plurality of annular stent rings, and a cylindrically shaped layer of graft material defining a lumen to which the stent rings are coupled. Main stent grafts are well known for use in tubular shaped human vascular or other body vessel.
Endovascular aneurysmal exclusion is a method of using a main stent graft to partially or completely isolate an aneurysmal sac from systemic blood pressure by preventing pressurized blood flow from pressurizing the interior of an aneurysm, thereby reducing the risk of rupture of the aneurysm and the need for an invasive surgical intervention.
Illustratively, the main (body) stent graft was placed in the main vessel, e.g., the aorta, to exclude an aneurysm. A (branch) fenestration (opening) in the side of the main body provides an opening for blood flow to a branch vessel which would otherwise be obstructed by the position of the main body across the ostium of the branch vessel. A branch graft or branch stent graft was then inserted through the side opening and into the branch vessel spanning any gap between the outside of the branch opening in the main body and the ostium of the branch vessel, and carrying blood across the gap without pressuring the aneurysm.
Initially, the main stent graft was deployed in the main vessel such that an opening in the sidewall of the main stent graft was aligned with the branch vessel. A branch graft having a silicone flange was then passed through the opening in the main stent graft and deployed in the branch vessel. The silicone flange was configured to engage with and seal with the opening in the sidewall of the main stent graft. However, the silicone flange had a relatively large delivery profile and was somewhat inflexible thus limiting the range of applications in which the silicone flange with attached branch grafts could be used.
SUMMARY OF THE INVENTIONIn accordance with one example, a braided flange branch graft formed of a braided super elastic memory material includes a neck between an inner flange and an outer flange. The neck is positioned in an opening in a sidewall of a main stent graft and the inner flange and outer flange are deployed on opposite sides of the sidewall.
The inner flange and the outer flange have a diameter greater than a diameter of the opening in the sidewall of the main stent graft. Thus, the sidewall of the main stent graft is sandwiched between the inner flange and the outer flange securely and simply mounting the braided flange branch graft to the main stent graft. Further, when longitudinally stretched into a substantially cylindrical shape for delivery, the braided flange branch graft has a small delivery profile and is extremely flexible.
Embodiments are best understood by reference to the following detailed description when read in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a side plan view of a braided flange branch graft in accordance with one embodiment;
FIG. 2 is a perspective view of the braided flange branch graft ofFIG. 1;
FIG. 3 is a cross-sectional view outline of the braided flange branch graft corresponding to the side plan view ofFIG. 1;
FIG. 4 is a cut away cross-sectional view of a braided flange branch graft delivery system for delivering the braided flange branch graft ofFIGS. 1 and 2 into the vasculature of a patient;
FIG. 5 is a cross-sectional view of a vessel system including the braided flange branch graft ofFIGS. 1 and 2 in its stretched shape in accordance with one embodiment; and
FIG. 6,7,8 are cross-sectional views of the vessel system ofFIG. 5 at further stages during deployment of the braided flange branch graft.
Common reference numerals are used throughout the drawings and detailed description to indicate like elements.
DETAILED DESCRIPTIONIn accordance with one example, referring toFIG. 7, a braidedflange branch graft100 formed of a braided super elastic memory material (e.g., nitinol) includes aneck106 between aninner flange102 and anouter flange104. Neck106 is positioned in aside opening506 in asidewall508 of amain stent graft502 andinner flange102 andouter flange104 are deployed on opposite sides ofsidewall508.Inner flange102 andouter flange104 have a diameter D1 greater than a diameter D3 ofside opening506. Thus,sidewall508 ofmain stent graft502 is sandwiched betweeninner flange102 andouter flange104 securely and simply mounting braidedflange branch graft100 tomain stent graft502. Further, referring toFIG. 5, when stretched into a substantially cylindrical shape for delivery, braidedflange branch graft100 has a small delivery profile and is extremely flexible.
More particularly,FIG. 1 is a side plan view of a braidedflange branch graft100, sometimes called a side branch, in accordance with one embodiment.FIG. 2 is a perspective view of braidedflange branch graft100 ofFIG. 1.FIG. 3 is across-sectional view outline300 of braidedflange branch graft100 corresponding to the side plan view ofFIG. 1.
Referring now toFIGS. 1,2 and3 together, braidedflange branch graft100 has a longitudinal axis L. As used herein, longitudinally means in a direction parallel to longitudinal axis L. Radially means in a direction perpendicular to longitudinal axis.
Braidedflange branch graft100 includes an inner, e.g., first,flange102, and an outer, e.g., second,flange104, aneck106, and atrunk108.
Neck106 is longitudinal betweeninner flange102 andouter flange104.Inner flange102 andouter flange104 extend radially outward fromneck106. More particularly,inner flange102 andouter flange104 have a first diameter D1 at outerradial perimeters110,112, respectively, greater than a second diameter D2 ofneck106. Accordingly,inner flange102,outer flange104, andneck106 collectively define anannular channel114.
Inner flange102, sometimes called an inner disk, is saucer shaped in accordance with this example. More particularly, outerradial perimeter110 ofinner flange102 is circular. Further, the thickness ofinner flange102 increases towards the radial center ofinner flange102. To illustrate, a first thickness T1 ofinner flange102 at outerradial perimeter110 is less than a second thickness T2 ofinner flange102 at the point whereinner flange102 meetsneck106.
Similarly,outer flange104, sometimes called an outer disk, is saucer shaped in accordance with this example. More particularly, outerradial perimeter112 ofouter flange104 is circular. Further, the thickness ofouter flange104 increases towards the radial center ofouter flange104. To illustrate, a first thickness T1 ofouter flange104 at outerradial perimeter112 is less than a second thickness T2 ofouter flange104 at the point whereouter flange104meet neck106.
Althoughinner flange102 andouter flange104 are described and illustrated as being saucer shaped, i.e., being in the shape of a disk that increases in thickness towards the radial center of the disk, in other examples,inner flange102 andouter flange104 are in the shape of a uniform thickness disk.
Trunk108 extends longitudinally outward fromouter flange104 in a direction oppositeinner flange102. Trunk108 includes abase109 attached toouter flange104. In accordance with this example,trunk108 is cylindrically shaped, the cylinder having longitudinal axis L.
Extending longitudinally through braidedflange branch graft100 is alumen116. More particularly, braidedflange branch graft100 includes aninner end118, e.g., a first longitudinal or proximal end, and anouter end120, e.g., a second longitudinal or distal end. An inner, e.g., first, opening122 oflumen116 is formed in the radial center ofinner flange102 atinner end118. A second opening124 oflumen116 is formed by the open end oftrunk108 atouter end120. As set forth further below, fluid, e.g., blood, passes throughlumen116, e.g., from a main vessel into a branch vessel.
Braidedflange branch graft100 is formed of a braided super elastic memory material, e.g., nitinol, in accordance with one example. Generally, a super elastic memory material is a memory material that can be stretched from the shape of braidedflange branch graft100 shown inFIGS. 1 and 2 into a cylinder (see braidedflange branch graft100 ofFIG. 5 for example) without permanent deformation of the memory material, i.e., the memory material will return from the cylinder to the shape of braidedflange branch graft100 shown inFIGS. 1 and 2 upon being released. A memory material is a material that can be set to have a specific shape, e.g., by heat setting, such that the material will return to the specific shape when the material is in its relaxed state.
Illustratively, the braid is made by intertwining strands of super elastic memory material, e.g., strands of nitinol. The strands are all of one type, e.g., nitinol, in one example.
In another example, two or more different types of strands are braided together to form braidedflange branch graft100. Illustratively, strands of a biocompatible polymer, e.g., polyester (PE) or polyester terephthalate (PET), are braided together with strands of a memory metal, e.g., nitinol, to form braidedflange branch graft100. For example, the biocompatible polymer encourages ingrowth of the surrounding body tissue into braidedflange branch graft100.
Illustratively, braidedflange branch graft100 is formed by heat setting a braided super elastic memory material. For example, a cylindrical shaped braid is forced over a mandrel having the shape of braidedflange branch graft100. In one example, the braid is clamped to the mandrel, for example, atneck106, to ensure conformity with the mandrel. The assembly is then heat set using a conventional technique. In one embodiment the ends of braidedflange branch graft100 are fused, crimped, folded, or otherwise prevented from unravelling.
As discussed further below, braidedflange branch graft100 is stretched into a substantially cylindrical shape. Upon being released, braidedflange branch graft100 returns to its relaxed state as illustrated inFIGS. 1 and 2.
In another example, referring now toFIG. 1, braidedflange branch graft100 includes anelastic cover126 illustrated by the dashed line. Illustratively, cover126 is a super elastic material that conforms to the stretched and relaxed shape of the braided super elastic memory material of braidedflange branch graft100. Illustratively, cover126 is elastic polytetrafluoroethylene (PTFE) over a nitinol braid.
FIG. 4 is a cross-sectional view of a braided flange branchgraft delivery system400 for delivering braidedflange branch graft100 ofFIGS. 1 and 2 into the vasculature of a patient. Referring now toFIG. 4,delivery system400 includes ahandle402. Aninner member404 extends distally fromhandle402. Braidedflange branch graft100 is located over adistal end406 ofinner member404. Braidedflange branch graft100 is partially cutaway in the view ofFIG. 4 for clarity of presentation. As used herein, the proximal end ofdelivery system400 is referenced with respect to the operator's handle, i.e., handle402, while the proximal end of braidedflange branch graft100 is referenced with respect to the end closest to the heart via the length of blood traveled from the heart. (In this example the distal and proximal ends of each coincide.)
Inner member404 is a hollow tubular member and includes a guide wire lumen. Aguide wire408 extends through the guide wire lumen ofinner member404.
Braidedflange branch graft100 is stretched into a substantially cylindrical shape bydelivery system400 to minimize the delivery profile of braidedflange branch graft100. Further, braidedflange branch graft100 is extremely flexible once stretched. Since braidedflange branch graft100 has a small delivery profile and is extremely flexible, braidedflange branch graft100 can be used in a wide variety of applications.
In accordance with this example, braidedflange branch graft100 is connected and stretched atinner end118,neck106,base109, andouter end120. More particularly, braidedflange branch graft100 is connected to aneck hook410 atneck106.Neck hook410 is fixed in position and doesn't move relative to handle402 in accordance with this example. Illustratively,neck hook410 is mounted directly toinner member404. After deployment of braidedflange branch graft100 as discussed further below,neck hook410 is pulled from and releases braidedflange branch graft100 asinner member404 is retracted.
Braidedflange branch graft100 is connected to aninner end hook412 atinner end118.Inner end hook412 is connected to an innerend hook slider414 ofhandle402 by an innerend hook connector416, e.g., a wire. Innerend hook slider414 is threadedly connected to an innerend adjustment ring418. Innerend adjustment ring418 is rotated, e.g., by the physician, thereby causing longitudinal translation of innerend hook slider414. More particularly, rotation of innerend adjustment ring418 causes proximal or distal motion (left or right motion in the view ofFIG. 4) of innerend hook slider414 depending upon the direction of rotation of innerend adjustment ring418.
Inner flange102 is stretched into a cylindrical shape betweeninner end hook412 andneck hook410. Illustratively,inner end hook412 is pulled proximally and towardshandle402 by innerend hook slider414 through innerend hook connector416. By rotating innerend adjustment ring418, innerend hook slider414 is moved distally towards braidedflange branch graft100. This releases the tension pulling oninner end hook412.Inner end hook412, in turn, releases the tension on braidedflange branch graft100 betweeninner end118 andneck106 thus allowinginner flange102 to return to its relaxed shape, e.g., to the saucer shape ofinner flange102. While only a single set of hooks (one for each position) is shown in the Figures, multiple hooks and/or sets of hooks may be utilized in multiple radial directions to stabilize or distribute the forces at each axial (lateral) hook position with its respective braided engagement postion.
However, should the positioning ofinner flange102 be unsatisfactory, innerend adjustment ring418 is rotated in the reverse direction. This causes innerend hook slider414 to move proximally away from braidedflange branch graft100. This increases the tension pulling oninner end hook412.Inner end hook412, in turn, increases the tension on braidedflange branch graft100 betweeninner end118 andneck106 thus causinginner flange102 to return to its stretched shape, e.g., to the cylindrical shape ofinner flange102 shown inFIG. 4. Braidedflange branch graft100 is then repositioned.
Once the positioning ofinner flange102 is satisfactory, continued distal travel ofinner end hook412 causesinner end hook412 to slip from and release braidedflange branch graft100 thus permanently deployinginner flange102.
Braidedflange branch graft100 is connected to abase hook420 atbase109.Base hook420 is connected to abase hook slider422 ofhandle402 by abase hook connector424, e.g., a pair of coaxial hypo tubes.Base hook slider422 is threadedly connected to abase adjustment ring426.
Base adjustment ring426 is rotated, e.g., by the physician, thereby causing longitudinal translation ofbase hook slider422. More particularly, rotation ofbase adjustment ring426 causes proximal or distal motion (left or right motion in the view ofFIG. 4) ofbase hook slider422 depending upon the direction of rotation ofbase adjustment ring426.
Outer flange104 is stretched into a cylindrical shape betweenbase hook420 andneck hook410. Illustratively,base hook420 is pushed distally and away fromhandle402 bybase hook slider422 throughbase hook connector424. By rotatingbase adjustment ring426,base hook slider422 is moved proximally away from braidedflange branch graft100. This releases the tension pushing onbase hook420.Base hook420, in turn, releases the tension on braidedflange branch graft100 betweenbase109 andneck106 thus allowingouter flange104 to return to its relaxed shape, e.g., to the saucer shape ofouter flange104.
However, should the positioning ofouter flange104 be unsatisfactory,base adjustment ring426 is rotated in the reverse direction. This causesbase hook slider422 to move distally towards braidedflange branch graft100. This increases the tension pushing onbase hook420.Base hook420, in turn, increases the tension on braidedflange branch graft100 betweenbase109 andneck106 thus causingouter flange104 to return to its stretched shape, e.g., to the cylindrical shape ofouter flange104 shown inFIG. 4. Braidedflange branch graft100 is then repositioned.
Once the positioning ofouter flange104 is satisfactory, continued proximal travel ofbase hook420 causesbase hook420 to slip from and release braidedflange branch graft100 thus permanently deployingouter flange104.
Braidedflange branch graft100 is connected to anouter end hook428 atouter end120.Outer end hook428 is connected to an outerend hook slider430 ofhandle402 by an outerend hook connector432, e.g., a pair of coaxial hypo tubes. Outerend hook slider430 is threadedly connected to an outerend adjustment ring434.
Outerend adjustment ring434 is rotated, e.g., by the physician, thereby causing longitudinal translation of outerend hook slider430. More particularly, rotation of outerend adjustment ring434 causes proximal or distal motion (left or right motion in the view ofFIG. 4) of outerend hook slider430 depending upon the direction of rotation of outerend adjustment ring434.
Trunk108 is stretched into an elongated cylindrical shape betweenouter end hook428 and neck hook410 (or base hook420). Illustratively,outer end hook428 is pushed distally and away fromhandle402 by outerend hook slider430 through outerend hook connector432. By rotating outerend adjustment ring434, outerend hook slider430 is moved proximally away from braidedflange branch graft100. This releases the tension pushing onouter end hook428.Outer end hook428, in turn, releases the tension on braidedflange branch graft100 thus allowingtrunk108 to return to its relaxed shape, e.g., to a shorter greater diameter cylinder.
However, should the positioning oftrunk108 be unsatisfactory, outerend adjustment ring434 is rotated in the reverse direction. This causes outerend hook slider430 to move distally towards braidedflange branch graft100. This increases the tension pushing onouter end hook428.Outer end hook428, in turn, increases the tension on braidedflange branch graft100 betweenouter end120 and neck106 (or base109) thus causingtrunk108 to return to its stretched shape, e.g., to the elongated cylindrical shape oftrunk108 shown inFIG. 4. Braidedflange branch graft100 is then repositioned.
Once the positioning oftrunk108 is satisfactory, continued proximal travel ofouter end hook428 causesouter end hook428 to slip from and release braidedflange branch graft100 thus permanently deployingtrunk108.
Although four points of attachment to braidedflange branch graft100 for controlled deployment are set forth above, in other examples, only two or three points of attachment are used. For example, onlyinner end hook412 andouter end hook428 are attached to braidedflange branch graft100 and braidedflange branch graft100 is stretched betweeninner end hook412 andouter end hook428.
In another example, onlyinner end hook412,neck hook410, andouter end hook428 are attached to braidedflange branch graft100. In accordance at this example, braidedflange branch graft100 is stretched betweeninner end hook412 andneck hook410, and betweenneck hook410 andouter end hook428. Further, other connection means can be used other than hooks.
In yet another example, braidedflange branch graft100 is constrained within a sheath of a delivery system. Retraction of the sheath exposes braidedflange branch graft100, which self-expands and is permanently deployed.
FIG. 5 is a cross-sectional view of avessel system500 including braidedflange branch graft100 ofFIGS. 1 and 2 in its stretched shape in accordance with one embodiment. Referring now toFIG. 5, amain stent graft502 is deployed within amain vessel504 using any one of a number of techniques well known to those of skill in the art. Illustratively,main stent graft502 is deployed to exclude an aneurysm inmain vessel504,main vessel504 having avessel wall505.
Aside opening506 in asidewall508 ofmain stent graft502 is aligned with abranch vessel510 emanating frommain vessel504. Braidedflange branch graft100, in its stretched cylindrical shape, is inserted throughside opening506 and intobranch vessel510, for example, usingdelivery system400 ofFIG. 4. Since braidedflange branch graft100 has a small delivery profile and is extremely flexible, braidedflange branch graft100 can be used in a wide variety of applications, e.g., in the case whenbranch vessel510 is small and difficult to reach.
Neck106 of braidedflange branch graft100 is positioned within side opening506 ofmain stent graft502, for example, using a radiopaque marker or other imaging technique.
FIG. 6 is a cross-sectional view ofvessel system500 ofFIG. 5 at a further stage during deployment of braidedflange branch graft100. Referring now toFIG. 6,inner flange102 is deployed. More particularly,inner flange102 is return to its relaxed shape, e.g., to its saucer shape, as shown inFIG. 6. Illustratively,inner flange102 is deployed as discussed above in reference todelivery system400 ofFIG. 4.Inner flange102 is deployed inside ofmain stent graft502.
FIG. 7 is a cross-sectional view ofvessel system500 ofFIG. 6 at a further stage during deployment of braidedflange branch graft100. Referring now toFIG. 7,outer flange104 is deployed. More particularly,outer flange104 is return to its relaxed shape, e.g., to its saucer shape, as shown inFIG. 7. Illustratively,outer flange104 is deployed as discussed above in reference todelivery system400 ofFIG. 4.Outer flange104 is deployed outside ofmain stent graft502 and betweenmain stent graft502 andvessel wall505.
As shown inFIG. 7,inner flange102 andouter flange104 are deployed on opposite sides ofsidewall508 ofmain stent graft502. Further,inner flange102 andouter flange104 have a first diameter D1 at outerradial perimeters110,112, respectively, greater than a second diameter D3 ofside opening506. Thus,sidewall508 ofmain stent graft502 is sandwiched betweeninner flange102 andouter flange104 mounting and sealing braidedflange branch graft100 tomain stent graft502. In one example, bothinner flange102 andouter flange104 push onsidewall508 ofmain stent graft502.
More particularly,sidewall508 is located withinannular channel114 defined byinner flange102,neck106, andouter flange104 of braidedflange branch graft100. Stated another way,inner flange102,neck106, andouter flange104 form a locking mechanism, sometimes called a means for locking, for locking braidedflange branch graft100 tomain stent graft502.
In this manner, braidedflange branch graft100 is securely mounted tomain stent graft502 forming an intra-vascular assembly. The connection between braidedflange branch graft100 andmain stent graft502 is achieved by simply and reliably deployinginner flange102 andouter flange104 on opposite sides ofsidewall508 ofmain stent graft502.
FIG. 8 is a cross-sectional view ofvessel system500 ofFIG. 7 at a further stage during deployment of braidedflange branch graft100. Referring now toFIG. 8,trunk108 is deployed. More particularly,trunk108 is return to its relaxed shape, e.g., to its shorter larger diameter cylindrical shape, as shown inFIG. 8. Illustratively,trunk108 is deployed as discussed above in reference todelivery system400 ofFIG. 4.
Trunk108 is deployed inside ofbranch vessel510. In one example,trunk108 self-expands intobranch vessel510 to maintain patency ofbranch vessel510. Once braidedflange branch graft100 is deployed, fluid, e.g., blood, passes throughlumen116 of braidedflange branch graft100, e.g., from the lumen defined bymain stent graft502 intobranch vessel510. More particularly,lumen116 of braidedflange branch graft100 is in fluid communication with the lumen ofmain stent graft502.Main stent graft502 and braidedflange branch graft100 collectively form anintra-vascular assembly802.
Although deployment ofinner flange102 before the deployment ofouter flange104 is set forth, in another example,outer flange104 is initially deployed and theninner flange102 is deployed. In yet another example, bothinner flange102 andouter flange104 are deployed simultaneously.
This disclosure provides exemplary embodiments. The scope is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification or not, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure.