US20080065115A1 - Systems and methods for applying a suture within a blood vessel lumen - Google Patents

Abstract

Systems and methods suture within a body organ region. The systems and methods advance into the body organ region a catheter tube having a distal region that carries a suture applicator. The systems and methods operate the suture applicator from a location external to the body to apply a suture to an interior wall in the body organ region.

Description

RELATED APPLICATION
• This application is a divisional of co-pending U.S. patent application Ser. No. 10/915,864, filed Aug. 11, 2004, which is a divisional of U.S. patent application Ser. No. 10/099,149 filed 15 Mar. 2002 (now U.S. Pat. No. 6,800,081), which is a divisional of application Ser. No. 09/787,135, filed Sep. 17, 1999, entitled “Endovascular Fastener Applicator,” which claims the benefit of U.S. Provisional Application Ser. No. 60/101,050 filed Sep. 18, 1998. This application also claims the benefit of U.S. patent application Ser. No. 09/640,554, filed Aug. 18, 2000, entitled “Endovascular Device for Application of Prosthesis with Sutures” (now U.S. Pat. No. 6,336,933), which is incorporated herein by reference, which is a continuation of U.S. patent application Ser. No. 09/266,200, filed Mar. 10, 1999, entitled “Endovascular Device for Application of Prosthesis with Sutures” (now abandoned), and which further claims the benefit of Argentine Patent Application Serial No. P19980101145, filed Mar. 13, 1998, entitled “Endovascular Device for Application of Prosthesis with Sutures.”
FIELD OF THE INVENTION
• This disclosure relates generally to vascular grafts for intraluminal delivery, and in particular, to a method and apparatus for repairing diseased or damaged sections of a vessel by fastening a prosthesis within the vessel.
BACKGROUND OF THE INVENTION
• Diseased or damaged blood vessels often cause weakening of the vessel wall resulting in an aneurysm whereby a blood vessel and especially an artery have a section of abnormal blood-filled dilation. For example, an abdominal aortic aneurysm is a sac caused by an abnormal dilation of the wall of the aorta, a major artery of the body as it passes through the abdomen.
• The abdominal aortic aneurysm usually arises in the infrarenal portion of the arteriosclerotically diseased aorta, for example, below the kidneys. Left untreated, the aneurysm will eventually cause rupture of the sac with ensuing fatal hemorrhaging in a very short time. High mortality associated with rupturing led the state of the art into trans-abdominal surgical repair of abdominal aortic aneurysms.
• Surgery involving the abdominal wall, however, is a major undertaking with associated high risks. This type of surgery, in essence, involves replacing the diseased and aneurysmal segment of blood vessel with a prosthetic device which typically is a synthetic tube, or graft, usually fabricated of either DACRON™, TEFLON™, or other suitable material.
• The present state of the art for intraluminal repair of a vessel does not fasten a prosthesis to the remaining aortic wall. For example, U.S. Pat. Nos. 5,571,171 and 5,571,173 disclose a method and apparatus for treating an abdominal aortic aneurysm by supplying a prosthesis or an aortic graft for intraluminal delivery that does not fasten the graft to the remaining aortic wall.
• Presenting an aortic graft through the aorta by intraluminal delivery avoids major invasive surgery. The '171 and '173 patents disclose an aortic graft that is delivered intraluminally to the aneurysm site. The aortic graft is secured to the remaining aortic wall by a balloon that is inflated thereby causing the graft to contact and adhere to the remaining aortic wall.
• The major disadvantages related to the combination of endovascular expanders, such as a balloon or stent, and prosthesis is the dilation of the natural artery with consequent migrations and periprosthetic losses. Upon withdrawal of the expander, the tissue is caused to collapse and the prosthesis disengages from the remaining aortic wall and tends to migrate to a location away from the aneurysm site to be repaired. The migration and movement of the disengaged aortic graft would then obstruct the affected vessel. The migration and movement of the aortic graft requires further treatment on the patient to remove the failed attempt to attach the aortic graft to the remaining aortic wall.
• Further treatment may include major surgery that is hazardous and traumatic to the patient. Major surgery to remove the aortic graft defeats the benefits of intraluminal delivery of the aortic graft. The current state of the art does not disclose a fastener applicator that intraluminally delivers a vascular graft and endoluminally applies internal fasteners to fasten a prosthesis in place.
• Accordingly, there is a present need for a fastener applicator that intraluminally delivers a vascular graft to a site within a vessel and applies fasteners to pass through both a prosthesis and the thickness of a vessel wall. The fastened prosthesis should also have the capability of following dilation of a vessel.
SUMMARY OF THE INVENTION
• The invention provides systems and methods for suturing within a body organ region, such as a blood vessel lumen. The systems and methods advance into the body organ region a catheter tube having a distal region that carries a suture applicator. The systems and methods operate the suture applicator from a location external to the body to apply a suture to an interior wall in the body organ region.
• Other features and advantages of the invention will be pointed out in, or will be apparent from, the drawings, specification and claims that follow.
DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of one embodiment of an endovascular fastener applicator in accordance with the present disclosure;
• FIG. 2 is a cross-sectional view, in part elevation, of an aortic graft placed at the site of all abdominal aortic aneurysm within the aorta;
• FIG. 3 is an enlarged detail view of a portion ofFIG. 2 illustrating the aortic graft secured to the remaining aortic wall and maintained in position by helical fasteners;
• FIG. 4 is a cross-sectional view, in part elevation, of an aortic graft for treating an aortic aneurysm affecting the aorta and both ileac arteries;
• FIG. 5 is a perspective view of a helical fastener;
• FIG. 6 is a side elevation view of a helical fastener;
• FIG. 7 is a bottom perspective view taken along line7-7 ofFIG. 6 of a helical fastener having a rectangular configuration at its limiting end for cooperating with a rectangular drive assembly;
• FIG. 8 is a cross-sectional view taken along line8-8 ofFIG. 7 of a helical fastener;
• FIG. 9 is a cross-sectional view, in part elevation, of an endovascular fastener applicator;
• FIG. 10 is a cross-sectional view, in part elevation, of a distal portion of the applicator at the aneurysm site;
• FIG. 11 is a cross-sectional view of the control assembly;
• FIG. 12 is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing an expandable portion causing a prosthesis to contact a vessel wall;
• FIG. 13 is a cross-sectional view of the control assembly;
• FIG. 14 is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing advance of a delivery tube;
• FIG. 15 is a cross-sectional view of the control assembly;
• FIG. 16 is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing advance of a drive assembly;
• FIG. 17 is a top view of a helical fastener defining a rectangular configuration at its limiting end for cooperating with a rectangular drive assembly, as shown in cross-section;
• FIG. 18 is a cross-sectional view of the control assembly;
• FIG. 19 is a cross-sectional view, in part elevation, of the delivery assembly showing rotation for insertion of a helical fastener;
• FIG. 20 is a cross-sectional view, in part elevation, of an alternate embodiment of the applicator showing the delivery assembly at the aneurysm with fastener guides;
• FIG. 21 is an enlarged detail view of a portion ofFIG. 20 illustrating a helical fastener guided over a drive attached to a fastener guide;
• FIG. 22 is a cross-sectional view, in part elevation, of a helical fastener taken along line22-22 ofFIG. 21;
• FIG. 23 is a plan view, in part cross-section, taken along line23-23 ofFIG. 20 showing the applicator with fastener guides,
• FIG. 24 is a perspective view of one embodiment of a fastener guide in accordance with the present disclosure;
• FIG. 25 is a perspective view, in part cross-section, showing movement of the helical fastener over a drive prior to collapsing the fastener guide;
• FIG. 26 is a perspective view, in part cross-section, showing the drive after the fastener guide is collapsed and the helical fastener deployed;
• FIG. 27 is a perspective view, showing retraction of the drive and fastener guide;
• FIG. 28 is a perspective view of an alternate embodiment of the control assembly;
• FIG. 29 is a perspective view of the distal end of an alternate embodiment of the drive assembly loaded with a plurality of helical fasteners;
• FIG. 30 is a perspective view showing a helical fastener for loading with a channel of the drive assembly;
• FIG. 31 is a perspective view of an alternate embodiment of a helical fastener;
• FIG. 32 is a perspective view of an applicator head and helical fasteners prior to deployment into a prosthesis;
• FIG. 33 is a perspective view of the helical fastener deployed into the prosthesis and artery;
• FIG. 34 is a perspective view of an alternate embodiment of the applicator showing the expandable portion in an expanded state;
• FIG. 35 is a perspective view of the expandable portion shown inFIG. 34 in a relaxed state;
• FIG. 36 is an exploded view of the delivery assembly shown inFIG. 34;
• FIG. 37 is an exploded view of the drive assembly shown inFIG. 34;
• FIG. 38 is a perspective view of the drive assembly shown inFIG. 34;
• FIG. 39 is a perspective view of an embodiment of an ejection mount;
• FIG. 40 is a perspective view of the ejection mount showing a set screw and cam divider for cooperating with the drive assembly;
• FIG. 41 is a cross-sectional view of the applicator with the expandable portion in a relaxed state and a prosthetic having a sealing gasket;
• FIG. 42 is a cross-sectional view, in part elevation, of the distal end of the applicator;
• FIG. 43 is a cross-sectional view, in part elevation, with the expandable portion in an expanded state;
• FIG. 44 is an enlarged cross-sectional view, in part elevation, of the distal end of the applicator;
• FIG. 45 is a perspective view of the expandable portion in an expanded state and the ejection mount loaded with helical fasteners;
• FIG. 46 is a cross-sectional view, in part elevation, with the ejection mount pivoted for deployment of helical fasteners;
• FIG. 46A is a perspective view, in part cross-section, an alternate embodiment of the ejection mount pivoted for deployment of helical fasteners;
• FIG. 47 is a cross-sectional view, in part elevation, of the ejection mount engaging the aortic graft prior to deployment of helical fasteners;
• FIG. 48 is a perspective view, in part cross-section, showing deployment of helical fasteners;
• FIG. 49 is a perspective view, in part-cross-section, showing retraction of the ejection mount;
• FIG. 50 is a cross-sectional view, in part elevation, showing the ejection mount subsequent to deployment of a helical fastener; and
• FIG. 51 is a top view of the applicator, showing movement of the ejection mount prior to deployment of a helical fastener.
• The invention is not limited to the details of the construction and the arrangements of parts set forth in the following description or shown in the drawings. The invention can be practiced in other embodiments and in various other ways. The terminology and phrases are used for description and should not be regarded as limiting.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• As illustrated inFIG. 1, the present disclosure relates to an endovascular fastener applicator, generally referred to asnumeral50.Endovascular fastener applicator50 deliversaortic graft100, as shown inFIGS. 2 and 3, for repairing an abdominalaortic aneurysm120 inaorta124 having twoiliac arteries126L and126R associated therewith, as well as a plurality ofrenal arteries130 located aboveaneurysm120 in fluid communication withaorta124. Repairing the aneurysm includes fastening anaortic graft100 to anaortic wall132 byfasteners80.Aortic graft100, as well as other prostheses, may be utilized in the thoracic aorta, and can be used to repair thoracic aneurysms or thoracic dissecting aneurysms. Further, thefastener applicator50 may also treat vascular trauma and other obstructive diseases with various prostheses. Accordingly, use of the term aortic aneurysm in this specification and claims is intended to relate to and mean both abdominal aortic aneurysms, thoracic aneurysms and related vessel diseases.
• Endovascular fastener applicator50 has adelivery assembly60 and acontrol assembly140.Delivery assembly60, as illustrated inFIG. 9, includes a tubular body, such as, for example, anouter sleeve64, anelongate control68, adelivery tube72 and adrive assembly76, each having a proximal and distal end relative to controlassembly140.Outer sleeve64 defines achannel65 and is adapted for insertion within aorta124 (as shown inFIG. 10) and has anexpandable portion66 operatively connected at its distal end.Elongate control68 is coaxially positioned withinchannel65 ofouter sleeve64 and is operatively connected toexpandable portion66 at its distal end.Delivery tube72 defines achannel71 and is coaxially positioned withinchannel65 ofouter sleeve64 and adapted for advancing ahelical fastener80 to the abdominal aortic aneurysm site. Driveassembly76 is coaxially positioned withinchannel71 ofdelivery tube72 and adapted for advancing, in cooperation withdelivery tube72, and deployinghelical fastener80 intoaortic graft100 andaorta wall132. It is contemplated that the components of the delivery assembly may be alternately oriented relative to each other, such as, for example, bi-axial, offset, etc. It is further contemplated that the components ofdelivery assembly60 are flexible and may be constructed from a shape memory material.
• Operation ofendovascular fastener applicator50 is controlled bycontrol assembly140. As shown inFIGS. 1 and 9,control assembly50 includes outersleeve push bar146,expandable portion control150, deliverytube push bar148 and handle144. Outersleeve push bar146 is operatively connected to the proximal end ofouter sleeve64 for regulating movement ofouter sleeve64.Expandable portion control150 is operatively connected to the proximal end ofelongate control68, which in turn is connected toexpandable portion66. Correspondingly,expandable portion control150 controls the expansible force AA (shown inFIG. 12) exerted byexpandable portion66 for supportingaortic graft100 in contact withaortic wall132. Outersleeve push bar146 may also be adapted to influence expansible force AA.
• Deliverytube push bar148 is operatively connected to the proximal end ofdelivery tube72 for regulating movement ofdelivery tube72. Handle144 is operatively connected to the proximal end ofdrive assembly76, for controlling axial and rotational movement ofdrive assembly76, described in detail below.
• As shown inFIG. 9, driveassembly76 includes adrive78.Drive78 at its distal end has acurved portion79 oriented at substantially90′ to the longitudinal axis ofouter sleeve64 and delivery tube72 (similarly shown inFIGS. 10 and 12). It is contemplated that the curved portion may be positioned at various angular orientations. Driveassembly76 transmits rotational motion from its proximal end to its distal end and through itscurved portion79 to facilitate deployment ofhelical fasteners80 into theaortic graft100 andaortic wall132.
• In one embodiment, as illustrated inFIGS. 5-8,helical fasteners80 have a sharpeneddistal end81 and apenetration limit end82.Helical fastener80 has anouter diameter83 and aninner diameter84.Outer diameter84 facilitates penetration of sharpeneddistal end81 intoaortic graft100 andaortic wall132. The surface ofinner diameter84 cooperatively engagesdrive assembly76 anddelivery tube72 at their distal ends to facilitate loading ofhelical fastener80 intoendovascular fastener applicator50. Preferably,inner diameter84 and penetration limitend82 have a rectangular configuration for cooperative engagement withdrive assembly76,drive assembly76 also having a rectangular configuration at its distal end. Although a helical fastener is disclosed it is contemplated thatfastener80 may have various configurations, such as, for example, cylindrical, triangular, etc. It is further contemplated thatfasteners80 are of the metallic fastener staple type and are preferably made from stainless steel but may be constructed from a polymeric material.
• In the embodiment illustrated inFIG. 9, drive78 is made from a shape memory alloy whereby drive78 assumes the curved configuration ofcurved portion79 upon exitingdelivery tube72.Delivery tube72 may also include anapplicator head73 at its distal end having a curved orientation to facilitate deployment ofhelical fasteners80, as shown inFIGS. 14, 16 and19.Helical fasteners80, as shown inFIG. 3, are deployed intoaortic graft100 andaortic wall132 for fastening.
• In an alternate embodiment, repair of abdominalaortic aneurysm120, as shown inFIG. 10, proceeds by insertion ofendovascular fastener applicator50 intoaorta124 and advancing to the abdominal aortic aneurysm site by manipulation by a surgeon ofcontrol assembly140.Endovascular fastener applicator50 deliversaortic graft100 to abdominalaortic aneurysm120 by advancing theaortic graft100 so that a sufficient portion ofaortic graft100 is brought in contact withaortic wall132.Aortic graft100 is a conventional tubular graft made of DACRON®, TEFLONV (polytetrafluoroethylene) and the like and is of a length sufficient to span the abdominalaortic aneurysm120.
• With reference toFIGS. 11-19,delivery assembly60 andaortic graft100 are delivered to the abdominal aneurysm site by manipulation of outersleeve push bar146, as shown by arrows A inFIG. 11.Aortic graft100 is positioned at the abdominal aneurysm site.Expandable portion66 is caused to expand, shown by arrows AA inFIG. 12, in response to cooperative manipulation of outersleeve push bar146 andelongate control68. Outward radial force AA supportsaortic graft100 in contact withaortic wall132.Expandable portion66 facilitates fastening ofaortic graft100 withaortic wall132 by deployment ofhelical fasteners80. In this embodiment,expandable portion66 includessupport members67 that defineinterstitial regions70 therebetween.Helical fasteners80 are deployed throughinterstitial regions70 and intoaortic graft100. It is contemplated thathelical fasteners80 may be deployed at various locations about the circumference ofaortic graft100 relative to the number ofsupport members67 and spacing ofinterstitial regions70.
• Deliverytube push bar148 is manipulated to axiallyadvance delivery tube72 withinouter sleeve64, as shown by arrows B inFIG. 13. At its distal end,delivery tube72 has anapplicator head73 configured to have a substantially perpendicular orientation to the longitudinal axis ofdelivery tube72.Drive78 follows the substantially perpendicular orientation ofdelivery tube72 to facilitate deployment ofhelical fasteners80. It is contemplated thatapplicator head73 may have various configurations and orientations to facilitate deployment ofhelical fasteners80.
• With reference toFIG. 14,delivery tube72 is advanced to a location whereaortic graft100 will be fastened toaortic wall132. A loadedhelical fastener80 is oriented for deployment byapplicator head73, as shown by arrowsC. Applicator head73 is articulable in a clockwise and a counter-clockwise direction about the inner surface ofgraft100.
• The surface ofinner diameter84 and penetration limitend82 ofhelical fastener80 have a rectangular configuration for cooperative engagement withdrive assembly76,drive assembly76 also having a rectangular configuration at its distal end(FIG. 17).
• It is contemplated that the remainder ofdrive assembly76 may not be in cooperative engagement with the surface ofinner diameter84.
• Helical fastener80 has a substantially circular cross-section. It is envisioned that other cross-sectional configurations may be used that are suitable for fastening.
• With reference toFIG. 15 and16, handle144 is manipulated to advancedrive assembly76. A torque is applied to handle144 transmitting a rotational force from the proximal end to the distal end ofdrive assembly76. The rectangular configuration ofdrive assembly76 cooperates with the rectangular configuration of the surface ofinner diameter84 causing rotational movement ofhelical fastener80. The sharpeneddistal end81 ofhelical fastener80 contacts theinterior wall102 ofaortic graft100 thereby facilitating deployment offastener80 intoaortic graft100 andaortic wall132.Helical fastener80 penetratesaortic graft100 andaortic wall132 to penetration limitend82 thereby fasteningaortic graft100 toaortic wall132.
• In the embodiment shown inFIG. 19,delivery tube72 cooperates withelongate control68 atjunction69.Junction69 facilitates rotation ofdelivery tube72 and driveassembly76 positioned coaxially therewithin, to a location for deployment ofhelical fasteners80, as shown inFIG. 19 byarrow D. Junction69 rotates by manipulation ofexpandable portion control150, as shown inFIG. 18.Delivery tube72 is retracted from the fastening site and loaded with anotherhelical fastener80 for subsequent deployment at another location along the diameter ofaortic graft100. As manyhelical fasteners80 may be deployed as are necessary to adequately fastenaortic graft100 toaortic wall132. Fastening in this manner prevents periprosthetic losses and accidental migration ofaortic graft100. It is contemplated that multiplehelical fasteners80 may be loaded intoendovascular fastener applicator50.
• In another embodiment, as shown inFIGS. 20-27,endovascular fastener applicator50 positionsaortic graft100 at the aneurysm site and in contact withaortic wall132. Referring toFIG. 20aortic graft100 includesband104 havinganchor pads107 implanted therewithin.
• As shown inFIG. 23,anchor pads107 are implanted circumferentially aboutband104. Band104 may be fabricated from, such as, for example, polytetrafluoroethylene.Anchor pads107, are implanted withinband104 corresponding tointerstitial regions70 located betweensupport members67 ofexpandable portion66. Referring toFIG. 23,pads107 have a substantially circular configuration. It is envisioned that the pads may have other configurations such as, for example, rectangular, elliptical, etc.
• Anchor pads107 cooperatively engage fastener guides106 positioned at the distal end ofdrive assembly76.Anchor pads107 and fastener guides106 cooperate to provide a guided deployment ofhelical fasteners80 and facile release ofdrive assembly76 from the aneurysm site. Referring toFIGS. 21 and 22,drive assembly76 further includesmultiple guide wires77 releasably attached to fastener guides106.Guide wires77 facilitate guided travel offasteners80.
• Referring back toFIG. 24, fastener guides106 includeanchor legs108. Anchorlegs108 are resiliently biased so that upon deployment ofhelical fastener80,anchor legs108 are caused to collapse and release fromband104. Anchorlegs108 are connected tomultiple guide wires77 so that after collapse and release ofanchor legs108,multiple guide wires77 are retracted from the fastening site.Anchor pad107 is retained withinband104 afterhelical fastener80 is deployed.
• As shown inFIG. 25,expandable portion66 supportsaortic graft100 in contact withaortic wall132.Applicator head73 ofdelivery tube72 is configured and dimensioned to cooperate withinner diameter84 to advance ahelical fastener80 overmultiple guide wires77, as shown by arrows E. Ashelical fastener80 is deployed, anchorlegs108 are caused to collapse, shown by arrows F inFIG. 26.Delivery tube72 causes rotational movement ofhelical fastener80 and corresponding penetration ofband104,aortic graft100 andaortic wall132, facilitating fastening.
• Delivery tube72 is retracted subsequent to deployment ofhelical fastener80 andmultiple guide wire77 is also retracted, as shown inFIG. 27, withhelical fastener80 in a deployed position.Delivery tube72 is subsequently loaded with anotherhelical fastener80 for deployment from another ofmultiple guide wires77. As manyhelical fasteners80 may be deployed as are necessary to adequately fastenaortic graft100 toaortic wall132. It is contemplated that at least a portion of the fastener guides and/or guide wires may remain fixed to the prosthetic upon deployment of a fastener.
• In another embodiment as shown inFIG. 28,control assembly140 includes ahandle110 and atrigger120 for controlling operation ofendovascular fastener applicator50. In this embodiment, handle110 controls advancement of delivery tube72 (not shown) and trigger120 controls advancement of drive assembly76 (not shown) and deployment of helical fasteners80 (not shown).
• In another embodiment, as illustrated inFIGS. 29-33, a plurality ofhelical fasteners80 are loaded inendovascular fastener applicator50 for deployment. As shown inFIG. 30,drive assembly76 defines achannel75 for accepting helical fasteners80 (FIG. 31). In particular, penetration limitend82 ofhelical fastener80 slidably engageschannel75 providing a plurality ofhelical fasteners80 for deployment, as shown inFIG. 29.Applicator head73 ofdelivery tube72 engagesband104, as shown inFIG. 32, and drive assembly76 advanceshelical fasteners80 to penetrateband104,aortic graft100 andaortic wall132, shown by arrows G. As shown inFIG. 33,aortic graft100 is fastened toaortic wall132 ofaorta124 byhelical fastener80. After deployment of ahelical fastener80,delivery tube72 is rotated to deploy another of the plurality ofhelical fasteners80, consequently reloading is not required.
• In another embodiment, as illustrated inFIGS. 34-51,expandable portion66 is capable of moving between two extreme positions. A relaxed position, as shown inFIG. 35, and an expanded position, as shown inFIG. 34. In the embodiment illustrated inFIG. 34,expandable portion66 includessupport members67 that define openinterstitial regions70.
• As best shown inFIG. 36,outer sleeve64 operatively engages withexpandable portion66 for controlling operation between the two extreme positions.Expandable portion66 has anatraumatic head200 attached to opening210 defined at the distal end ofexpandable portion66 andopening212 defined at its proximal end for receivingapplicator head73 ofdelivery tube72.Applicator head73 includesejection mount250 for deployment of a plurality ofhelical fasteners80 fromdrive assembly76.
• Ejection mount250, as shown inFIG. 36, includesyoke256 andejection head260.Yoke256 engagespenetration head200 for coaxial positioning withinexpandable portion66.Ejection head260 is pivotally positioned withinyoke256.Ejection head260 includes acam divider262 and a saw-toothed face264.Ejection head260 is capable of rotational movement relative todelivery tube72 and pivotal movement between two extreme positions. A first extreme position is coaxial withdelivery tube72 and a second extreme position is perpendicular to the longitudinal axis ofdelivery tube72 and in position to deploy ahelical fastener80.
• With reference toFIGS. 37 and 38,drive assembly76 includesdistal drive280,proximal drive284,outer drive285,ratchet assembly286,spring294 andwasher296.Distal drive280 defines aslot281 for receivingpenetration limit end82 for loading a plurality ofhelical fasteners80. The plurality ofhelical fasteners80 are spring loaded ontodrive assembly76 and separated fromspring294 bywasher296.
• Distal drive280 is operatively connected to ratchetassembly286 which is operatively connected toproximal drive284 andouter drive285.Ratchet assembly286 includesratchet sleeve287 which defines opening288 for receipt ofdistal drive280. Manipulation ofproximal drive284 causes movement ofdistal drive280 to facilitate deployment ofhelical fasteners80.Ratchet sleeve287 also defines opening289 for receipt ofproximal drive284.Ratchet sleeve287 is slidably received withinratchet retainer290 for cooperative engagement withouter drive285.Ratchet retainer290 defines opening291 for receivingratchet arm292.
• As shown inFIGS. 39 and 40,ratchet arm292 engagesejection head260.Ratchet arm292 is positioned withincam divider262 inejection head260 and secured therein byset screw298. It is contemplated thatratchet arm292 is crimped in place withinejection head260 and that no set screw is required. It is further contemplated thatratchet arm292 may be fixed withinejection head260 as is known by one skilled in the art. Manipulation ofouter drive285 engagesratchet retainer290 and ratchetarm292 causing pivotal movement ofejection head260 relative todelivery tube72.
• As illustrated inFIGS. 41 and 42,delivery assembly60 is positioned at the aneurysm site of abdominalaortic aneurysm120.Aortic graft100 is positioned for fastening toaortic wall132 ofaorta124.Aortic graft100 hasband104.Aortic graft100 may also havegasket105, as shown inFIG. 41, sewn to the outside diameter ofaortic graft100 to prevent leakage of fluid.
• Expandable portion66 is in a relaxed state, as shown inFIGS. 41 and 42.Aortic graft100 is positioned at the abdominal aneurysm site andexpandable portion66 is caused to expand by axial motion ofouter sleeve64, shown by arrows I inFIG. 44 and by arrows H inFIG. 43, illustrating the outward force ofsupport members67 used to supportaortic graft100 in contact withaortic wall132.Expandable portion66 facilitates fastening ofaortic graft100 withaortic wall132 for deployment ofhelical fasteners80 by securingaortic graft100 in contact withaortic wall132. It is contemplated thathelical fasteners80 may be deployed fromejection mount250 throughinterstitial regions70 betweensupport members67. Thehelical fasteners80 arc deployed about the circumference ofaortic graft100 relative to the number ofsupport members67 and spacing ofinterstitial regions70.
• As shown inFIG. 45,drive assembly76 is loaded with a plurality ofhelical fasteners80. Referring toFIG. 46,delivery tube72 has anejection arm310 positioned at its distal end facilitating pivotal movement ofejection mount250. Anarm292 functions as an ejection arm toejection head260. This provides extra holding force on the graft which pivotsejection head260 positioned at its distal end.Ejection arm310 includes aslider312 received within acam slot300 defined byejection head260.Cam slot300 further defines the relative movable limits ofslider312 and thusejection arm310.
• Delivery tube72 is manipulated advancingejection arm310 axially causing pivotal movement ofejection head260, shown by avow J, andpositioning ejection head260 for deployment ofhelical fasteners80.Ejection head260 is positioned in a substantially perpendicular orientation to the longitudinal axis ofdelivery tube72.
• It is contemplated thatejection arm310 has alternate orientations for causing movement ofejection head260. For example, in an alternate embodiment shown inFIG. 46A,ejection head260 pivots withinexpandable portion66 and is positioned at the center ofexpandable portion66. Saw-toothed face264 is positioned at a closer proximity to the inner surface ofgraft100 for accurate deployment of a fastener. At the center position,ejection head260 spans a diameter thatexpandable portion66 supportsaortic graft100 in contact withaortic wall132. In this embodiment,ejection arm310 is fixed at a maximum angle relative todelivery tube72.
• Driveassembly76 is manipulated so thatejection head260 engagesband104 ofaortic graft100 for deployment ofhelical fasteners80, as illustrated inFIG. 47.Outer drive285 andproximal drive284 are advanced, shown by arrowsK. Ejection arm292 correspondingly axially positions saw-tooth face264 ofejection head260 to contactband104 ofaortic graft100, as shown by arrowL. Ejection arm292 may also cause rotational movement ofejection head260 and saw-tooth face264 for engagingaortic graft100.
• With reference toFIG. 48,distal drive280 advances and is rotated causinghelical fasteners80 to penetrate and fastenaortic graft100 andaortic wall132, as shown by arrow M.
• As shown inFIG. 49,delivery tube72 is manipulated so thatejection arm310 pivotally retractsejection head260 to a position substantially parallel to the longitudinal axis ofdelivery tube72, as shown by arrows MM.
• FIG. 50 illustrates a retractedejection mount250 subsequent to deployment of one of a plurality ofhelical fasteners80. A rotational force is transmitted from the proximal end to the distal end ofdrive assembly76, shown by arrows N, thereby driving and axially advancing another of the plurality ofhelical fasteners80, shown by arrows P, for deployment byejection head260 at a new deployment site.
• FIG. 51shows ejection head260 positioned in a substantially perpendicular orientation to the longitudinal axis of delivery tube72 (not shown).Ejection head260 is rotated to a new deployment site to deploy another of the plurality of helical fasteners80 (not shown). As manyhelical fasteners80 may be deployed as are necessary to adequately fastenaortic graft100 toaortic wall132.
• It will be understood that various modifications may be made to the embodiments disclosed herein. For example, while specific preferred embodiments of the endovascular fastener applicator have been described in detail, structures that perform substantially the same function in substantially the same way to achieve substantially the same result may also be used. For example, the expandable portion may include expanding wires for supporting a prostheses in contact with a vessel wall. Also the fastener guide may be implanted completely through the thickness of the aortic graft. Further, the helical fasteners may be constructed from various suitable materials or may embody one continuous fastener that is severable at the point of insertion. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments, those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.
• Features and advantages of the invention are set forth in the following claims.

Claims (14)

1. An endovascular suture assembly comprising an elongated endovascular device including a spiral suture applicator including a rotary head, the elongated endovascular device being sized and configured for advancement within a blood vessel lumen,

a tissue-piercing spiral suture carried by the rotary head for advancement into a vascular wall of the blood vessel lumen in response to operation of the rotary head, and

a component that is sized and configured to be moved into a stabilizing condition against a vascular wall within the blood vessel lumen to apply a stabilization force within the blood vessel during advancement of the tissue-piercing spiral suture into a vascular wall.

2. An assembly according toclaim 1

wherein the segment comprises an expandable body.

3. An assembly according toclaim 2

further including a mechanism coupled to the expandable body to selectively expand the expandable body toward an opened condition within a blood vessel lumen and to selectively collapse the expandable body toward a closed condition for advancement with the distal region within a blood vessel lumen.

4. An assembly according toclaim 1

further including a mechanism coupled to the suture applicator to selectively move the rotary head relative to the segment.

5. A method comprising

selecting a region within a blood vessel lumen for placement of a tissue-piercing spiral suture,

providing a spiral suture applicator sized and configured for endovascular advancement within a blood vessel lumen to the region, the spiral suture applicator including a component operable from a location external to a blood vessel lumen to advance a tissue-piercing spiral suture into tissue,

placing at least one tissue-piercing spiral suture in operative association with the component,

advancing the spiral suture applicator within a blood vessel lumen into the region, and

operating the component from a location external to the blood vessel lumen to advance the at least one tissue-piercing spiral suture into a vascular wall in the region.

6. A method according toclaim 5

further including stabilizing the component during operation.

7. A method for suturing within a body organ region comprising the steps of

advancing into the body organ region a catheter tube having a distal region that carries a suture applicator, and

operating the suture applicator from a location external to the body to apply a suture to an interior wall in the body organ region.

8. A method according toclaim 7

further including a step of stabilizing the distal region of the catheter tube during operation of the suture applicator.

9. A method according toclaim 7

wherein the distal region of the catheter carries a component that is sized and configured to be moved into a stabilizing condition against the interior wall to apply a stabilization force within the body organ during advancement of the tissue-piercing spiral suture into the interior wall, and

further including moving the component into the stabilizing condition against the interior wall to apply a stabilization force within the body organ during advancement of the tissue-piercing spiral suture into the interior wall.

10. A method according toclaim 7

wherein, during operation, the suture applicator applies a spiral suture.

11. A method according toclaim 7

wherein the body organ region comprises a blood vessel lumen.

12. A method for suturing a prosthesis to a blood vessel wall comprising operating a suture applicator carried on a distal end of an endovascular catheter from a location external to a blood vessel lumen to apply a spiral suture to secure the prosthesis to a blood vessel wall.

13. A method comprising

selecting a region within a blood vessel lumen for placement of a prosthesis,

advancing the prosthesis within a blood vessel lumen into contact with a vascular wall in the region,

advancing a spiral suture applicator within a blood vessel lumen into the region, the spiral suture applicator including a component operable from a location external to the blood vessel lumen to advance a tissue-piercing spiral suture into tissue, and

operating the component from a location external to a blood vessel lumen to advance at least one tissue-piercing spiral suture into the prosthesis and a vascular wall in the region.

14. A method according toclaim 13

further including stabilizing the component during operation.

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