Systems and methods for applying a suture within a blood vessel lumen

Systems and methods apply a suture within a blood vessel lumen. The systems and methods advance within a blood vessel lumen 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 blood vessel lumen to apply a suture to an interior wall of a blood vessel lumen.

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 applying a suture within a blood vessel lumen. The systems and methods advance within a blood vessel lumen 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 blood vessel lumen to apply a suture to an interior wall of a blood vessel lumen.

Other features and advantages of the invention will be pointed out in, or will be apparent from, the drawings, specification and claims that follow.

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 as numeral50. Endovascular fastener applicator50delivers aortic graft100, as shown inFIGS. 2 and 3, for repairing an abdominal aortic aneurysm120in aorta124having two iliac arteries126L and126R associated therewith, as well as a plurality of renal arteries130located above aneurysm120in fluid communication with aorta124. Repairing the aneurysm includes fastening an aortic graft100to an aortic wall132by fasteners80. 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, the fastener applicator50may 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 applicator50has a delivery assembly60and a control assembly140. Delivery assembly60, as illustrated inFIG. 9, includes a tubular body, such as, for example, an outer sleeve64, an elongate control68, a delivery tube72and a drive assembly76, each having a proximal and distal end relative to control assembly140. Outer sleeve64defines a channel65and is adapted for insertion within aorta124(as shown inFIG. 10) and has an expandable portion66operatively connected at its distal end. Elongate control68is coaxially positioned within channel65of outer sleeve64and is operatively connected to expandable portion66at its distal end. Delivery tube72defines a channel71and is coaxially positioned within channel65of outer sleeve64and adapted for advancing a helical fastener80to the abdominal aortic aneurysm site. Drive assembly76is coaxially positioned within channel71of delivery tube72and adapted for advancing, in cooperation with delivery tube72, and deploying helical fastener80into aortic graft100and aorta 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 of delivery assembly60are flexible and may be constructed from a shape memory material.

Operation of endovascular fastener applicator50is controlled by control assembly140. As shown inFIGS. 1 and 9, control assembly50includes outer sleeve push bar146, expandable portion control150, delivery tube push bar148and handle144. Outer sleeve push bar146is operatively connected to the proximal end of outer sleeve64for regulating movement of outer sleeve64. Expandable portion control150is operatively connected to the proximal end of elongate control68, which in turn is connected to expandable portion66. Correspondingly, expandable portion control150controls the expansible force AA (shown inFIG. 12) exerted by expandable portion66for supporting aortic graft100in contact with aortic wall132. Outer sleeve push bar146may also be adapted to influence expansible force AA.

Delivery tube push bar148is operatively connected to the proximal end of delivery tube72for regulating movement of delivery tube72. Handle144is operatively connected to the proximal end of drive assembly76, for controlling axial and rotational movement of drive assembly76, described in detail below.

As shown inFIG. 9, drive assembly76includes a drive78. Drive78at its distal end has a curved portion79oriented at substantially 90′ to the longitudinal axis of outer sleeve64and delivery tube72(similarly shown inFIGS. 10 and 12). It is contemplated that the curved portion may be positioned at various angular orientations. Drive assembly76transmits rotational motion from its proximal end to its distal end and through its curved portion79to facilitate deployment of helical fasteners80into the aortic graft100and aortic wall132.

In one embodiment, as illustrated inFIGS. 5-8, helical fasteners80have a sharpened distal end81and a penetration limit end82. Helical fastener80has an outer diameter83and an inner diameter84. Outer diameter84facilitates penetration of sharpened distal end81into aortic graft100and aortic wall132. The surface of inner diameter84cooperatively engages drive assembly76and delivery tube72at their distal ends to facilitate loading of helical fastener80into endovascular fastener applicator50. Preferably, inner diameter84and penetration limit end82have a rectangular configuration for cooperative engagement with drive assembly76, drive assembly76also having a rectangular configuration at its distal end. Although a helical fastener is disclosed it is contemplated that fastener80may have various configurations, such as, for example, cylindrical, triangular, etc. It is further contemplated that fasteners80are 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, drive78is made from a shape memory alloy whereby drive78assumes the curved configuration of curved portion79upon exiting delivery tube72. Delivery tube72may also include an applicator head73at its distal end having a curved orientation to facilitate deployment of helical fasteners80, as shown inFIGS. 14,16and19. Helical fasteners80, as shown inFIG. 3, are deployed into aortic graft100and aortic wall132for fastening.

In an alternate embodiment, repair of abdominal aortic aneurysm120, as shown inFIG. 10, proceeds by insertion of endovascular fastener applicator50into aorta124and advancing to the abdominal aortic aneurysm site by manipulation by a surgeon of control assembly140. Endovascular fastener applicator50delivers aortic graft100to abdominal aortic aneurysm120by advancing the aortic graft100so that a sufficient portion of aortic graft100is brought in contact with aortic wall132. Aortic graft100is a conventional tubular graft made of DACRON®, TEFLONV (polytetrafluoroethylene) and the like and is of a length sufficient to span the abdominal aortic aneurysm120.

With reference toFIGS. 11-19, delivery assembly60and aortic graft100are delivered to the abdominal aneurysm site by manipulation of outer sleeve push bar146, as shown by arrows A inFIG. 11. Aortic graft100is positioned at the abdominal aneurysm site. Expandable portion66is caused to expand, shown by arrows AA inFIG. 12, in response to cooperative manipulation of outer sleeve push bar146and elongate control68. Outward radial force AA supports aortic graft100in contact with aortic wall132. Expandable portion66facilitates fastening of aortic graft100with aortic wall132by deployment of helical fasteners80. In this embodiment, expandable portion66includes support members67that define interstitial regions70therebetween. Helical fasteners80are deployed through interstitial regions70and into aortic graft100. It is contemplated that helical fasteners80may be deployed at various locations about the circumference of aortic graft100relative to the number of support members67and spacing of interstitial regions70.

Delivery tube push bar148is manipulated to axially advance delivery tube72within outer sleeve64, as shown by arrows B inFIG. 13. At its distal end, delivery tube72has an applicator head73configured to have a substantially perpendicular orientation to the longitudinal axis of delivery tube72. Drive78follows the substantially perpendicular orientation of delivery tube72to facilitate deployment of helical fasteners80. It is contemplated that applicator head73may have various configurations and orientations to facilitate deployment of helical fasteners80.

With reference toFIG. 14, delivery tube72is advanced to a location where aortic graft100will be fastened to aortic wall132. A loaded helical fastener80is oriented for deployment by applicator head73, as shown by arrows C. Applicator head73is articulable in a clockwise and a counter-clockwise direction about the inner surface of graft100.

The surface of inner diameter84and penetration limit end82of helical fastener80have a rectangular configuration for cooperative engagement with drive assembly76, drive assembly76also having a rectangular configuration at its distal end (FIG. 17).

It is contemplated that the remainder of drive assembly76may not be in cooperative engagement with the surface of inner diameter84.

Helical fastener80has a substantially circular cross-section. It is envisioned that other cross-sectional configurations may be used that are suitable for fastening.

With reference toFIGS. 15 and 16, handle144is manipulated to advance drive assembly76. A torque is applied to handle144transmitting a rotational force from the proximal end to the distal end of drive assembly76. The rectangular configuration of drive assembly76cooperates with the rectangular configuration of the surface of inner diameter84causing rotational movement of helical fastener80. The sharpened distal end81of helical fastener80contacts the interior wall102of aortic graft100thereby facilitating deployment of fastener80into aortic graft100and aortic wall132. Helical fastener80penetrates aortic graft100and aortic wall132to penetration limit end82thereby fastening aortic graft100to aortic wall132.

In the embodiment shown inFIG. 19, delivery tube72cooperates with elongate control68at junction69. Junction69facilitates rotation of delivery tube72and drive assembly76positioned coaxially therewithin, to a location for deployment of helical fasteners80, as shown inFIG. 19by arrow D. Junction69rotates by manipulation of expandable portion control150, as shown inFIG. 18. Delivery tube72is retracted from the fastening site and loaded with another helical fastener80for subsequent deployment at another location along the diameter of aortic graft100. As many helical fasteners80may be deployed as are necessary to adequately fasten aortic graft100to aortic wall132. Fastening in this manner prevents periprosthetic losses and accidental migration of aortic graft100. It is contemplated that multiple helical fasteners80may be loaded into endovascular fastener applicator50.

In another embodiment, as shown inFIGS. 20-27, endovascular fastener applicator50positions aortic graft100at the aneurysm site and in contact with aortic wall132. Referring toFIG. 20aortic graft100includes band104having anchor pads107implanted therewithin.

As shown inFIG. 23, anchor pads107are implanted circumferentially about band104. Band104may be fabricated from, such as, for example, polytetrafluoroethylene. Anchor pads107, are implanted within band104corresponding to interstitial regions70located between support members67of expandable portion66. Referring toFIG. 23, pads107have a substantially circular configuration. It is envisioned that the pads may have other configurations such as, for example, rectangular, elliptical, etc.

Anchor pads107cooperatively engage fastener guides106positioned at the distal end of drive assembly76. Anchor pads107and fastener guides106cooperate to provide a guided deployment of helical fasteners80and facile release of drive assembly76from the aneurysm site. Referring toFIGS. 21 and 22, drive assembly76further includes multiple guide wires77releasably attached to fastener guides106. Guide wires77facilitate guided travel of fasteners80.

Referring back toFIG. 24, fastener guides106include anchor legs108. Anchor legs108are resiliently biased so that upon deployment of helical fastener80, anchor legs108are caused to collapse and release from band104. Anchor legs108are connected to multiple guide wires77so that after collapse and release of anchor legs108, multiple guide wires77are retracted from the fastening site. Anchor pad107is retained within band104after helical fastener80is deployed.

As shown inFIG. 25, expandable portion66supports aortic graft100in contact with aortic wall132. Applicator head73of delivery tube72is configured and dimensioned to cooperate with inner diameter84to advance a helical fastener80over multiple guide wires77, as shown by arrows E. As helical fastener80is deployed, anchor legs108are caused to collapse, shown by arrows F inFIG. 26. Delivery tube72causes rotational movement of helical fastener80and corresponding penetration of band104, aortic graft100and aortic wall132, facilitating fastening.

Delivery tube72is retracted subsequent to deployment of helical fastener80and multiple guide wire77is also retracted, as shown inFIG. 27, with helical fastener80in a deployed position. Delivery tube72is subsequently loaded with another helical fastener80for deployment from another of multiple guide wires77. As many helical fasteners80may be deployed as are necessary to adequately fasten aortic graft100to aortic 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 assembly140includes a handle110and a trigger120for controlling operation of endovascular fastener applicator50. In this embodiment, handle110controls advancement of delivery tube72(not shown) and trigger120controls advancement of drive assembly76(not shown) and deployment of helical fasteners80(not shown).

In another embodiment, as illustrated inFIGS. 29-33, a plurality of helical fasteners80are loaded in endovascular fastener applicator50for deployment. As shown inFIG. 30, drive assembly76defines a channel75for accepting helical fasteners80(FIG. 31). In particular, penetration limit end82of helical fastener80slidably engages channel75providing a plurality of helical fasteners80for deployment, as shown inFIG. 29. Applicator head73of delivery tube72engages band104, as shown inFIG. 32, and drive assembly76advances helical fasteners80to penetrate band104, aortic graft100and aortic wall132, shown by arrows G. As shown inFIG. 33, aortic graft100is fastened to aortic wall132of aorta124by helical fastener80. After deployment of a helical fastener80, delivery tube72is rotated to deploy another of the plurality of helical fasteners80, consequently reloading is not required.

In another embodiment, as illustrated inFIGS. 34-51, expandable portion66is 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 portion66includes support members67that define open interstitial regions70.

As best shown inFIG. 36, outer sleeve64operatively engages with expandable portion66for controlling operation between the two extreme positions. Expandable portion66has an atraumatic head200attached to opening210defined at the distal end of expandable portion66and opening212defined at its proximal end for receiving applicator head73of delivery tube72. Applicator head73includes ejection mount250for deployment of a plurality of helical fasteners80from drive assembly76.

Ejection mount250, as shown inFIG. 36, includes yoke256and ejection head260. Yoke256engages penetration head200for coaxial positioning within expandable portion66. Ejection head260is pivotally positioned within yoke256. Ejection head260includes a cam divider262and a saw-toothed face264. Ejection head260is capable of rotational movement relative to delivery tube72and pivotal movement between two extreme positions. A first extreme position is coaxial with delivery tube72and a second extreme position is perpendicular to the longitudinal axis of delivery tube72and in position to deploy a helical fastener80.

With reference toFIGS. 37 and 38, drive assembly76includes distal drive280, proximal drive284, outer drive285, ratchet assembly286, spring294and washer296. Distal drive280defines a slot281for receiving penetration limit end82for loading a plurality of helical fasteners80. The plurality of helical fasteners80are spring loaded onto drive assembly76and separated from spring294by washer296.

Distal drive280is operatively connected to ratchet assembly286which is operatively connected to proximal drive284and outer drive285. Ratchet assembly286includes ratchet sleeve287which defines opening288for receipt of distal drive280. Manipulation of proximal drive284causes movement of distal drive280to facilitate deployment of helical fasteners80. Ratchet sleeve287also defines opening289for receipt of proximal drive284. Ratchet sleeve287is slidably received within ratchet retainer290for cooperative engagement with outer drive285. Ratchet retainer290defines opening291for receiving ratchet arm292.

As shown inFIGS. 39 and 40, ratchet arm292engages ejection head260. Ratchet arm292is positioned within cam divider262in ejection head260and secured therein by set screw298. It is contemplated that ratchet arm292is crimped in place within ejection head260and that no set screw is required. It is further contemplated that ratchet arm292may be fixed within ejection head260as is known by one skilled in the art. Manipulation of outer drive285engages ratchet retainer290and ratchet arm292causing pivotal movement of ejection head260relative to delivery tube72.

As illustrated inFIGS. 41 and 42, delivery assembly60is positioned at the aneurysm site of abdominal aortic aneurysm120. Aortic graft100is positioned for fastening to aortic wall132of aorta124. Aortic graft100has band104. Aortic graft100may also have gasket105, as shown inFIG. 41, sewn to the outside diameter of aortic graft100to prevent leakage of fluid.

Expandable portion66is in a relaxed state, as shown inFIGS. 41 and 42. Aortic graft100is positioned at the abdominal aneurysm site and expandable portion66is caused to expand by axial motion of outer sleeve64, shown by arrows I inFIG. 44and by arrows H inFIG. 43, illustrating the outward force of support members67used to support aortic graft100in contact with aortic wall132. Expandable portion66facilitates fastening of aortic graft100with aortic wall132for deployment of helical fasteners80by securing aortic graft100in contact with aortic wall132. It is contemplated that helical fasteners80may be deployed from ejection mount250through interstitial regions70between support members67. The helical fasteners80arc deployed about the circumference of aortic graft100relative to the number of support members67and spacing of interstitial regions70.

As shown inFIG. 45, drive assembly76is loaded with a plurality of helical fasteners80. Referring toFIG. 46, delivery tube72has an ejection arm310positioned at its distal end facilitating pivotal movement of ejection mount250. An arm292functions as an ejection arm to ejection head260. This provides extra holding force on the graft which pivots ejection head260positioned at its distal end. Ejection arm310includes a slider312received within a cam slot300defined by ejection head260. Cam slot300further defines the relative movable limits of slider312and thus ejection arm310.

Delivery tube72is manipulated advancing ejection arm310axially causing pivotal movement of ejection head260, shown by avow J, and positioning ejection head260for deployment of helical fasteners80. Ejection head260is positioned in a substantially perpendicular orientation to the longitudinal axis of delivery tube72.

It is contemplated that ejection arm310has alternate orientations for causing movement of ejection head260. For example, in an alternate embodiment shown inFIG. 46A, ejection head260pivots within expandable portion66and is positioned at the center of expandable portion66. Saw-toothed face264is positioned at a closer proximity to the inner surface of graft100for accurate deployment of a fastener. At the center position, ejection head260spans a diameter that expandable portion66supports aortic graft100in contact with aortic wall132. In this embodiment, ejection arm310is fixed at a maximum angle relative to delivery tube72.

With reference toFIG. 48, distal drive280advances and is rotated causing helical fasteners80to penetrate and fasten aortic graft100and aortic wall132, as shown by arrow M.

As shown inFIG. 49, delivery tube72is manipulated so that ejection arm310pivotally retracts ejection head260to a position substantially parallel to the longitudinal axis of delivery tube72, as shown by arrows MM.

FIG. 50illustrates a retracted ejection mount250subsequent to deployment of one of a plurality of helical fasteners80. A rotational force is transmitted from the proximal end to the distal end of drive assembly76, shown by arrows N, thereby driving and axially advancing another of the plurality of helical fasteners80, shown by arrows P, for deployment by ejection head260at a new deployment site.

FIG. 51shows ejection head260positioned in a substantially perpendicular orientation to the longitudinal axis of delivery tube72(not shown). Ejection head260is rotated to a new deployment site to deploy another of the plurality of helical fasteners80(not shown). As many helical fasteners80may be deployed as are necessary to adequately fasten aortic graft100to aortic 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.