US20110295355A1 - Bloused stent-graft and fenestration method - Google Patents
Bloused stent-graft and fenestration method Download PDFInfo
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- US20110295355A1 US20110295355A1 US13/206,755 US201113206755A US2011295355A1 US 20110295355 A1 US20110295355 A1 US 20110295355A1 US 201113206755 A US201113206755 A US 201113206755A US 2011295355 A1 US2011295355 A1 US 2011295355A1
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- bloused
- section
- graft
- puncture device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
Abstract
A method includes deploying a bloused stent-graft into a main vessel such that a bloused section of the bloused stent-graft covers a branch vessel emanating from the main vessel. The bloused section includes loose graft cloth. A pressure differential between the main vessel and the branch vessel causes the bloused section to be forced into an ostium of the branch vessel creating a pocket aligned with the branch vessel. A distal tip of a puncture device is located in the pocket and thus aligned with the branch vessel. An outward force is applied to the puncture device to cause the distal tip of the puncture device to fenestrate the bloused section thus creating a collateral opening in the bloused section precisely aligned with the branch vessel.
Description
- 1. Field of the Invention
- The present invention relates to an intra-vascular device and method. More particularly, the present invention relates to a device for treatment of intra-vascular diseases.
- 2. Description of Related Art
- A conventional main (vessel) 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, sometimes called graft cloth, defining a lumen to which the stent rings are coupled. Main stent-grafts are well known for use in tubular shaped human vessels.
- To illustrate, endovascular aneurysmal exclusion is a method of using a main stent-graft to exclude pressurized fluid flow from the interior of an aneurysm, thereby reducing the risk of rupture of the aneurysm and the associated invasive surgical intervention.
- Main stent-grafts with custom side openings are sometimes fabricated to accommodate the particular vessel geometry of each individual patient. Specifically, as the location of branch vessels emanating from a main vessel, e.g., having the aneurysm, varies from patient to patient, main stent-grafts are fabricated with side openings customized to match the position of the branch vessels of the particular patient. However, custom fabrication of main stent-grafts is relatively expensive and time consuming.
- To avoid custom fabrication of main stent-grafts, side openings in the main stent-graft may be formed in situ. Illustratively, the main stent-graft is placed in the main vessel, e.g., the aorta, to exclude an aneurysm. Fenestrations may be made in situ to correspond to adjacent branches.
- The graft material of the main stent-graft is pierced with a needle at the ostium of a branch vessel, e.g., the renal artery, emanating from the main vessel. Alignment of the needle with the center of the ostium of the branch vessel is accomplished using radiopaque markers on the needle. However, due to difficulties in accurately placement of the needle, the graft material of the main stent graft is often pierced offset from the center of the ostium of the branch vessel, which is undesirable.
- In accordance with one example, a method includes deploying a bloused stent-graft into a main vessel such that a bloused section of the bloused stent-graft covers a branch vessel emanating from the main vessel. The bloused stent-graft includes a proximal section, a distal section, and the bloused section attached to and between the proximal section and the distal section. The bloused section includes loose graft cloth.
- A pressure differential between the main vessel and the branch vessel causes the bloused section to be forced into an ostium of the branch vessel creating a pocket aligned with the branch vessel.
- A distal tip of a puncture device is located in the pocket and thus aligned with the branch vessel. An outward force is applied to the puncture device to cause the distal tip of the puncture device to fenestrate the bloused section thus creating a collateral opening in the bloused section precisely aligned with the branch vessel.
- As set forth above, by forming the bloused section with loose graft cloth, the pocket is self-aligned with the branch vessel as the loose graft cloth is forced into the branch vessel. The pocket, in turn, facilitates self-alignment of the puncture device with the branch vessel. Accordingly, fenestration of the bloused section with the puncture device creates the collateral opening precisely aligned with the branch vessel.
- Embodiments are best understood by reference to the following detailed description when read in conjunction with the accompanying drawings.
-
FIG. 1 is a perspective view of a bloused stent-graft in accordance with one embodiment; -
FIG. 2 is a cross-sectional view of the bloused stent-graft ofFIG. 1 ; -
FIG. 3 is a cross-sectional view of a vessel assembly including the bloused stent-graft ofFIGS. 1 and 2 in accordance with one embodiment; -
FIG. 4 is an enlarged cross-sectional view of a region IV of the vessel assembly ofFIG. 3 ; -
FIG. 5 is an enlarged cross-sectional view of the vessel assembly ofFIG. 4 during fenestration of the bloused stent-graft; -
FIG. 5 A is an enlarged schematic cross-sectional view of the vessel assembly ofFIG. 4 showing an alternate configuration to that shown inFIG. 5 ; and -
FIG. 6 is an enlarged schematic cross-sectional view of the vessel assembly ofFIG. 5 after fenestration of the bloused stent-graft. - Common reference numerals are used throughout the drawings and detailed description to indicate like elements.
- Referring to
FIG. 3 , a method includes deploying a bloused stent-graft 100 into amain vessel 302 such that a blousedsection 110 of bloused stent-graft 100 covers abranch vessel 306 emanating frommain vessel 302. Blousedsection 110 includes loose graft cloth. - Referring now to
FIGS. 3 and 4 together, a pressure differential betweenmain vessel 302 andbranch vessel 306 causes blousedsection 110 to be forced into anostium 310 ofbranch vessel 306 creating apocket 316 precisely aligned withbranch vessel 306. - Referring now to
FIG. 5 , adistal tip 504 of asteerable puncture device 502 is located inpocket 316 and thus precisely aligned withbranch vessel 306. An outward force is applied tosteerable puncture device 502 to causedistal tip 504 ofsteerable puncture device 502 to fenestrate blousedsection 110 thus creating a collateral opening 602 (FIG. 6 ) in blousedsection 110 precisely aligned withbranch vessel 306. - Referring now to
FIG. 5A , adistal tip 504 of asteerable puncture device 502 is contained within aguide catheter 702 located inpocket 316 and thus the puncture device is positioned to be precisely aligned withbranch vessel 306. An outward force is applied tosteerable puncture device 502 to move it forward within theguide catheter 702 to causedistal tip 504 ofsteerable puncture device 502 to fenestrate blousedsection 110 thus creating a collateral opening 602 (FIG. 6 ) in blousedsection 110 precisely aligned withbranch vessel 306. - More particularly,
FIG. 1 is a perspective view of a bloused stent-graft 100, e.g., an abdominal aortic stent-graft, in accordance with one embodiment. Referring now toFIG. 1 , bloused stent-graft 100 includesstent rings stent rings bare stent ring 102 is optional. -
FIG. 2 is a cross-sectional view of bloused stent-graft 100 ofFIG. 1 . InFIG. 2 ,stent rings - Referring now to
FIGS. 1 and 2 together, bloused stent-graft 100 includes aproximal section 108, abloused section 110, and adistal section 112, sometimes called a proximal segment, a bloused segment and a distal segment, respectively.Bloused section 110 is attached to and betweenproximal section 108 anddistal section 112. A series of “V” shaped pleats are shown at the top and bottom of the bloused section, to cause the larger diameter cylindrical blouse section material to be narrowed to match the proximal 108 anddistal section 112 smaller diameters. - As used herein, the proximal end of a prosthesis such as a stent-graft is the end closest to the heart via the path of blood flow whereas the distal end is the end furthest away from the heart during deployment. In contrast and of note, the distal end of the catheter is usually identified to the end that is farthest from the operator (handle) while the proximal end of the catheter is the end nearest the operator (handle).
- For purposes of clarity of discussion, as used herein, the distal end of the catheter (steerable puncture device) is the end that is farthest from the operator (the end furthest from the handle) while the distal end of the prosthesis is the end nearest the operator (the end nearest the handle), i.e., the distal end of the catheter and the proximal end of the stent-graft are the ends furthest from the handle while the proximal end of the catheter and the distal end of the stent-graft are the ends nearest the handle. However, those of skill in the art will understand that depending upon the access location, the stent-graft and delivery system description may be consistent or opposite in actual usage.
-
Proximal section 108 includes aproximal end 108P and adistal end 108D.Bloused section 110 includes aproximal end 110P and adistal end 110D.Distal end 108D ofproximal section 108 is attached toproximal end 110P of blousedsection 110 by an attachment means 114. Illustratively, attachment means 114 is stitching, adhesive, thermal bonding, or other attachment betweenproximal section 108 and blousedsection 110. -
Distal section 112 includes aproximal end 112P and adistal end 112D.Proximal end 112P ofdistal section 112 is attached todistal end 110D of blousedsection 110 by an attachment means 116. Illustratively, attachment means 116 is stitching, adhesive, thermal bonding, or other attachment between blousedsection 110 anddistal section 112. - Bloused stent-
graft 100 includes a proximalmain opening 118 at aproximal end 100P on bloused stent-graft 100 and a distalmain opening 120 at adistal end 100D of bloused stent-graft 100. Further, bloused stent-graft 100 includes a longitudinal axis L. Amain lumen 122 is defined by bloused stent-graft 100 and extends generally parallel to longitudinal axis L and between proximalmain opening 118 and distalmain opening 120 of bloused stent-graft 100. -
Proximal section 108 anddistal section 112 are cylindrical having substantially uniform diameters D1, D2, respectively. In contrast, blousedsection 110 has a non-uniform diameter having minimum diameters D1, D2 atproximal end 110P anddistal end 110D and ballooning outward (increasing in diameter) therefrom. - In one embodiment,
proximal section 108 is a first cylindrical piece of graft material, e.g., graft cloth, having a diameter D1.Distal section 112 is a second cylindrical piece of graft material, e.g., graft cloth, having a diameter D2. In the example illustrated inFIGS. 1 and 2 , diameter D1 is equal to diameter D2, although in other examples diameter D1 is greater than diameter D2 or vice versa. -
Bloused section 110 is formed from a third cylindrical piece of graft material, e.g., graft cloth, that has a diameter for example 50% larger than diameters D1, D2 ofproximal section 108 anddistal section 112, respectively. The ends of this cylindrical piece of graft material are attached, e.g., sewn, toproximal section 108 anddistal section 112 creating blousedsection 110. The bloused section must be large enough be seen under fluoroscopy which is expected when the peak diameter of the bloused section is from 10 to 60% larger than either adjacent section diameter D1 or D2. Accordingly, blousedsection 110 balloons, sometimes called bulges, protrudes or extends, outward fromproximal section 108 anddistal section 112. The maximum diameter D3 of blousedsection 110 is greater than diameter D1 or diameter D2.Bloused section 110 includes pleated loose graft cloth at each end where attachment to adjacent diameters D1, D2, sometimes called excess graft cloth, an overlarge bloused segment of graft cloth or slack graft cloth. In addition to pleating, another sewing method that could be used to attach the ends of the large diameter bloused section to the smaller diameter cylindrical section is “gathering” wherein what is meant here is that a tiny bit of extra cloth is gathered under each stitch to capture more material, i.e., a micropleat. Additionally the bloused portion could be specially woven to have cylindrically concave shape (so a cylindrical section of stent graft extends outwardly outside the proximal and distal diameters in an approximately spherical, ellipsoid, or similar continuous bulging surface shape) to avoid the need to have narrowed end portions such as provided by bunching, pleating, or gathering. The bloused section could also be constructed by using a cylindrical section of graft material of the larger bloused section maximum diameter and cutting pie shaped sections from both the proximal and distal end of the material at for example six evenly spaced circumferential locations around each end and sewing the sides of the remaining portions of the graft material (petal shaped sections) so that then the diameters of both the proximal and distal ends of the bloused section substantially match and can be sewn (or otherwise attached) to the proximal and distal substantially constant diameter end sections. In contrast,proximal section 108 anddistal section 112 are circumferentially taut, i.e., have little to no give or slack. - Referring again to
FIG. 1 , in accordance with one example, blousedsection 110 includesradiopaque ink 124 that allows visualization of blousedsection 110. In one example,radiopaque ink 124 is applied, e.g., printed, as a stipple pattern to the graft material of blousedsection 110. In this manner, flexibility of blousedsection 110 is maintained while at the same time visualization of blousedsection 110 is facilitated. However, in another embodiment, a bloused section similar to blousedsection 110 is formed with an absence of radiopaque ink. -
Stent ring 102, e.g., a first stent ring, is attached, e.g., sewn, toproximal section 108 atproximal end 108P thereof.Stent ring 102, sometimes called a suprarenal stent ring, extends proximally fromproximal section 108. This stent ring is optional. -
Stent ring 104, e.g., a second stent ring, is attached, e.g., sewn, toproximal section 108. Similarly,stent ring 106, e.g., a third stent ring, is attached, e.g., sewn, todistal section 112. - Stent rings 102, 104, 106, are self-expanding facilitating expansion, fixation, and sealing of bloused stent-
graft 100 into the main vessel as discussed further below. In another example, a bloused stent-graft similar to bloused stent-graft 100 is formed with stent rings that are balloon expanded facilitating fixation and sealing of the bloused stent-graft into the main vessel.Bloused section 110 has an absence of stent rings. - Although three stent rings 102, 104, 106 are illustrated, in other examples, a bloused stent-graft similar to bloused stent-
graft 100 is formed with more or less than three stent rings or other self-expanding members. -
FIG. 3 is a cross-sectional view of avessel assembly 300 including bloused stent-graft 100 ofFIGS. 1 and 2 in accordance with one embodiment. Referring now toFIG. 3 , amain vessel 302, e.g., the aorta, includes ananeurysm 304. Bloused stent-graft 100, sometimes called a prosthesis, is deployed intomain vessel 302 to excludeaneurysm 304 using any one of a number of techniques well known to those of skill in the art. - Emanating from
main vessel 302 is afirst branch vessel 306 and asecond branch vessel 308, sometimes called visceral branches of the abdominal aorta. The location ofbranch vessels - Bloused stent-
graft 100 is deployed such that blousedsection 110 is aligned withbranch vessels graft 100 is deployed such thatblouse section 110 covers ostia (plural of ostium) 310, 312 ofbranch vessels -
Proximal section 108 is located proximally toostia branch vessels graft 100 is deployed with fixation and sealing superior tobranch vessels Distal section 112 is located distally toostia branch vessels - Stent rings 102, 104, 106 are radially expandable reinforcement structures that self-expand into a
vessel wall 314 ofmain vessel 302 thus anchoring bloused stent-graft 100 in place. Bloused stent-graft 100 is delivered tomain vessel 302 and deployed therein using any one of a number of techniques well known to those of skill in the art. - Once anchored within
main vessel 302, blood flows throughmain lumen 122 and more generally through bloused stent-graft 100 thus excludinganeurysm 304. Further, blood pressure within bloused stent-graft 100 createspockets section 110. More particularly, the pressure inside of bloused stent-graft 100 is greater than the pressure withinbranch vessels section 110, which is loose, is forced intoostia branch vessels pockets ostia branch vessels - To illustrate,
FIG. 4 is an enlarged cross-sectional view of a region IV ofvessel assembly 300 ofFIG. 3 . As illustrated inFIG. 4 , blousedsection 110 follows the contour ofvessel wall 314 ofmain vessel 302. Further, blousedsection 110 follows the contour ofostium 310, which is illustrated as being enlarged due to disease. -
Pocket 316 is a region defined by the portion of blousedsection 110 extending radially outward intobranch vessel 306.Pocket 316 is the region between an imaginary cylindrical surface defined byvessel wall 314 as indicated by the dashedline 402 inFIG. 4 to the portion of blousedsection 110 extending radially outward intobranch vessel 306.Pocket 316 includes an apex 404, i.e., the most radial outward portion of blousedsection 110.Bloused section 110 tapers radially outward in a rounded conical shape to apex 404 fromvessel wall 314.Apex 404, and more generally,pocket 316, is precisely aligned withbranch vessel 306. - Returning to
FIG. 3 , the location ofbranch vessels section 110 is aligned with both ofbranch vessels pocket 318 is precisely aligned withbranch vessel 308 in a manner similar to that discussed above regarding alignment ofpocket 316 withbranch vessel 306 and so is not repeated here. -
FIG. 5 is an enlarged cross-sectional view ofvessel assembly 300 ofFIG. 4 during fenestration of bloused stent-graft 100. Referring now toFIG. 5 , to form a side opening, sometimes called a collateral opening, in bloused stent-graft 100, and more particularly, blousedsection 110, corresponding to (at)branch vessel 306, asteerable puncture device 502 is advanced to the location ofbranch vessel 306. Steerable puncture devices similar tosteerable puncture device 502 are well known to those of skill in the art. -
Steerable puncture device 502 is oriented radially, e.g., at a 90 degree angle, relative to longitudinal axis L and thus points atbloused section 110 of bloused stent-graft 100. More particularly, adistal tip 504 ofsteerable puncture device 502 is located withinpocket 316 and rests against (contacts)apex 404. Accordingly,steerable puncture device 502 is precisely aligned withbranch vessel 306. - In one example,
steerable puncture device 502 includes aradiopaque marker 506 that allows visualization ofsteerable puncture device 502. As set forth above, in one example, blousedsection 110 includesradiopaque ink 124 that allows visualization of blousedsection 110. Accordingly, bothsteerable puncture device 502 and blousedsection 110 are visualized to ensure precise alignment ofsteerable puncture device 502 withinpocket 316. - Further, in one example, in the event of initial misalignment of
steerable puncture device 502 withapex 404 as illustrated by thephantom lines 508, outward radial force onsteerable puncture device 502 causessteerable puncture device 502 to slide down the taper ofpocket 316 and toapex 404. Once located atapex 404, further outward force onsteerable puncture device 502 causesdistal tip 504, e.g., a sharp tip, to fenestrate (penetrate) blousedsection 110 precisely in alignment withbranch vessel 306. -
FIG. 5A is an enlarged cross-sectional view ofvessel assembly 300 ofFIG. 4 during an alternate method of fenestration of bloused stent-graft 100. Referring now toFIG. 5A , to form a side opening, sometimes called a collateral opening, in bloused stent-graft 100, and more particularly, blousedsection 110, corresponding to (at)branch vessel 306, a steerable guide catheter 702 (such as those manufactured by Enpath and Cardima) having apuncture device 502 contained therein is advanced to the location ofbranch vessel 306. The end of the steerable guide catheter is blunt to minimize the chances of the end of the device catching in the graft cloth. A blunt or rounded end permits smooth sliding of the end of steerable catheter in contact with the graft (pocket) surface. The puncture device can be advanced simultaneously with the steerable guide catheter, or can be inserted within the steerable guide catheter after the steerable guide catheter has been positioned within the bloused pocket. - The end of
steerable guide catheter 702 with thepuncture device 502 contained therein is oriented radially, e.g., at a 90 degree angle, relative to longitudinal axis L and thus points atbloused section 110 of bloused stent-graft 100. More particularly, a distal tip of theguide catheter 702 is located withinpocket 316 and rests against (contacts)apex 404. Accordingly, thepuncture device 502 contained in thesteerable guide catheter 702 is precisely aligned withbranch vessel 306. - As is well known in the art, steerable guide catheters are constructed of materials which provide visualization of its position under fluoroscopy. As set forth above, in one example, bloused
section 110 includesradiopaque ink 124 that allows visualization of blousedsection 110. Accordingly, both steerable guidecatheter 702 and blousedsection 110 are visualized to ensure precise alignment of thesteerable guide catheter 702 andpuncture device 502 withinpocket 316. - Further, in one example, in the event of initial misalignment of the
steerable guide catheter 702 with thepuncture device 502 contained therein withapex 404 as illustrated by thephantom lines 708, outward radial force on theguide catheter 702 causes the blunt end of theguide catheter 702 to slide down the taper ofpocket 316 and toapex 404. Once the steerable guide catheter is located atapex 404, the puncture device is advanced within thesteerable guide catheter 702 to contact the bloused section of graft material, further outward force on thepuncture device 502 allows itsdistal tip 504, e.g., a sharp tip, to fenestrate (penetrate) blousedsection 110 precisely in alignment withbranch vessel 306. -
FIG. 6 is an enlarged schematic cross-sectional view ofvessel assembly 300 ofFIGS. 5 and 5A after fenestration of bloused stent-graft 100. Referring now toFIGS. 5 , 5A, and 6 together, after fenestration of blousedsection 110 withsteerable puncture device 502 and removal ofsteerable puncture device 502, acollateral opening 602 is formed in bloused stent-graft 100. More particularly,collateral opening 602 is formed in blousedsection 110.Collateral opening 602 facilitates blood flow frommain lumen 122 of bloused stent-graft 100 throughcollateral opening 602 and intobranch vessel 306, thus perfusingbranch vessel 306. Further, blousedsection 110 follows the contour ofostium 310 effectively forming abranch graft 604 extending intobranch vessel 306. - By forming bloused
section 110 with loose graft cloth,pocket 316 is self-aligned withbranch vessel 306 as the loose graft cloth is forced intobranch vessel 306.Pocket 316, in turn, facilitates self-alignment ofsteerable puncture device 502 withbranch vessel 306. Accordingly, fenestration of blousedsection 110 withsteerable puncture device 502 createscollateral opening 602 precisely aligned withbranch vessel 306. - Returning now to
FIGS. 3 , 4, 5, 5A, and 6 together,steerable puncture device 502 is used to form a collateral opening in bloused stent-graft 100 in alignment withbranch vessel 308 in a similar manner to formation ofcollateral opening 602 as discussed above and so is not repeated here. In accordance with the above example, a method of fenestration in situ of bloused stent-graft 100 is provided to address the problem of perfusing visceral branches of the abdominal aorta with an abdominalaortic aneurysm 304 in which bloused stent-graft 100 is deployed with fixation and sealing superior to the renal arteries (RA) and superior mesenteric artery (SMA). - 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.
Claims (17)
1-15. (canceled)
16. A method comprising:
deploying a bloused stein-graft into a main vessel such that a bloused section of said bloused stent-graft covers a first branch vessel emanating from said main vessel, said bloused stent-graft comprising:
a proximal section comprising a first cylindrical piece of graft material having a first diameter;
a first stent ring attached to said proximal section;
a distal section comprising a second cylindrical piece of graft material having a second diameter;
a second stent ring attached to said distal section; and
said bloused section attached to and between said proximal section and said distal section, said bloused section comprising loose graft cloth, wherein said bloused section comprises a third cylindrical piece of graft material having a third diameter greater than said first diameter and said second diameter, said bloused section comprising v-shaped pleats to cause said third diameter to be narrowed to said first diameter and said second diameter at ends of said third cylindrical piece of graft material, wherein said ends of said third cylindrical piece of graft material are attached to said proximal section and said distal section to form said bloused section,
wherein a pressure differential between said main vessel and said first branch vessel causes said bloused section to be forced into an ostium of said first branch vessel creating a pocket aligned with said first branch vessel; and
locating a distal tip of a puncture device in said pocket.
17. The method of claim 16 wherein said pocket is defined by a portion of said bloused section extending into said first branch vessel.
18. The method of claim 16 wherein said pocket comprises an apex, said bloused section tapering radially outward from a vessel wall of said main vessel to said apex.
19. The method of claim 16 wherein said puncture device is oriented radially relative to a longitudinal axis of said bloused stent-graft within said pocket.
20. The method of claim 16 wherein said distal tip of said puncture device contacts an apex of said pocket.
21. The method of claim 16 wherein said puncture device comprises a radiopaque marker and wherein said bloused section comprises radiopaque ink facilitating visualization of alignment of said puncture device within said pocket.
22. The method of claim 16 wherein said puncture device comprises a guide catheter being fluoroscopically visible and wherein said bloused section comprises radiopaque ink facilitating visualization of alignment of said guide catheter within said pocket.
23. The method of claim 22 , wherein said guide catheter is a steerable guide catheter.
24. The method of claim 16 wherein said locating a distal tip of a puncture device in said pocket comprises applying an outward radial force on said puncture device to cause said puncture device to slide down a taper of said pocket to an apex of said pocket.
25. The method of claim 22 wherein said locating a distal tip of a puncture device in said pocket comprises applying an outward radial force on said guide catheter to cause said guide catheter to slide down a taper of said pocket to an apex of said pocket.
26. The method of claim 16 further comprising applying outward force on said puncture device to cause said distal tip of said puncture device to fenestrate said bloused section in alignment with said first branch vessel.
27. The method of claim 22 , wherein a puncture device catheter is contained within said guide catheter and further comprising applying outward force on said puncture device catheter to cause said distal tip of said puncture device to fenestrate said bloused section in alignment with said first branch vessel.
28. The method of claim 26 wherein said fenestration of said bloused section comprises creating a collateral opening in said bloused section, said collateral opening being aligned with said first branch vessel.
29. The method of claim 28 wherein said first branch vessel is perfused through said collateral opening.
30. The method of claim 28 wherein said bloused section follows a contour of an ostium of said first branch vessel forming a branch graft extending into said first branch vessel.
31. (canceled)
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US13/206,755 US20110295355A1 (en) | 2008-03-20 | 2011-08-10 | Bloused stent-graft and fenestration method |
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US12/052,591 US8100960B2 (en) | 2008-03-20 | 2008-03-20 | Bloused stent-graft and fenestration method |
US13/206,755 US20110295355A1 (en) | 2008-03-20 | 2011-08-10 | Bloused stent-graft and fenestration method |
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US12/052,591 Division US8100960B2 (en) | 2008-03-20 | 2008-03-20 | Bloused stent-graft and fenestration method |
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US13/206,755 Abandoned US20110295355A1 (en) | 2008-03-20 | 2011-08-10 | Bloused stent-graft and fenestration method |
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Legal Events
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Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |