US20110029013A1 - Vascular Hole Closure Device - Google Patents

Abstract

A device for closing an aperture in a vessel wall comprising a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture and having a first opening. A first retainer is positionable external of the vessel. A flexible connecting member operatively connects the covering member and the first retainer, wherein the first opening of the covering member is configured to restrict movement of the connecting member.

Description

• This application claims priority from provisional application No. 61/241,555, filed Sep. 11, 2009 and is a continuation in part of application Ser. No. 12/358,411, filed Jan. 23, 2009 which claims priority from provisional application Ser. No. 61/066,072, filed Feb. 15, 2008. The entire contents of each of these applications are incorporated herein by reference.
BACKGROUND
• 1. Technical Field
• This application relates to a vascular device and more particularly to a device for closing openings in vessel walls.
• 2. Background of Related Art
• During certain types of vascular surgery, catheters are inserted through an incision in the skin and underlying tissue to access the femoral artery in the patient's leg. The catheter is then inserted through the access opening made in the wall of the femoral artery and guided through the artery to the desired site to perform surgical procedures such as angioplasty or plaque removal. After the surgical procedure is completed and the catheter is removed from the patient, the access hole must be closed. This is quite difficult not only because of the high blood flow from the artery, but also because there are many layers of tissue that must be penetrated to reach the femoral artery.
• Several approaches to date have been used to close femoral access holes. In one approach, manual compression by hand over the puncture site is augmented by a sandbag or weight until the blood coagulates. With this approach, it can take up to six hours for the vessel hole to close and for the patient to be able to ambulate. This inefficiency increases the surgical procedure time as well as the overall cost of the procedure since the hospital staff must physically maintain pressure and the patient's discharge is delayed because of the inability to ambulate.
• In another approach to close the vessel puncture site, a clamp is attached to the operating table and the patient's leg. The clamp applies pressure to the vessel opening. The patient, however, must still be monitored to ensure the blood is coagulating, requiring additional time of the hospital staff and increasing the cost of the procedure.
• To avoid the foregoing disadvantages of manual pressure approaches, suturing devices have been developed. One such suturing device, sold by Abbott, advances needles adjacent the vessel wall opening and pulls suture material outwardly through the wall adjacent the opening. The surgeon then ties a knot in the suture, closing the opening. One difficulty with the procedure involves the number of steps required by the surgeon to deploy the needles, capture the suture, withdraw the suture, and tie the knot and secure the suture. Moreover, the surgeon cannot easily visualize the suture because of the depth of the femoral artery (relative to the skin) and essentially ties the suture knot blindly or blindly slips a pre-tied knot into position. Additionally, the ability to tie the knot varies among surgeons; therefore success and accuracy of the hole closure can be dependent on the skill of the surgeon. Yet another disadvantage of this suturing instrument is that the vessel opening is widened for insertion of the instrument, thus creating a bigger opening to close in the case of failure to deliver the closure system. It is also difficult to pass the needle through calcified vessels.
• U.S. Pat. No. 4,744,364 discloses another approach for sealing a vessel puncture in the form of a device having an expandable closure member with a filament for pulling it against the vessel wall. The closure member is held in place by a strip of tape placed on the skin to hold the filament in place. However, the closure device is still subject to movement which can cause leakage through the puncture. Additionally, if the suture becomes loose, the closure member is not retained and can flow downstream in the vessel. Moreover, since the suture extends through the skin, a potential pathway for infection is created. The closure device in U.S. Pat. No. 5,545,178 includes a resorbable collagen foam plug located within the puncture tract. However, since coagulation typically takes up to twenty minutes and blood can leak in between the plug and tissue tract, manual pressure must be applied to the puncture for a period of time, until the collagen plug expands within the tract.
• It would therefore be advantageous to provide a device which would more quickly and effectively close openings (punctures) in vessel walls. Such device would advantageously avoid the aforementioned time and expense of applying manual pressure to the opening, simplify the steps required to close the opening, avoid widening of the opening, and more effectively retain the closure device in the vessel.
• Commonly assigned U.S. Pat. No. 7,662,161 discloses effective vascular hole closure devices which have the foregoing advantages. It would be further advantageous to provide a vascular hole closure device which is adjustable to accommodate different tissue thicknesses and applies a more constant clamping/retaining force between the intravascular and extravascular components of the device irrespective of tissue thickness.
SUMMARY
• The present invention overcomes the disadvantages and deficiencies of the prior art. The present invention provides a device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall. The device comprises a covering member positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture and having a first opening. A first retainer is positionable external of the vessel. A flexible connecting member operatively connects the covering member and the first retainer and advances the retainer toward the covering member. The first opening of the covering member is configured to restrict movement of the connecting member.
• Preferably the connecting member comprises a first suture and the first retainer is attached to the first suture whereby pulling of the first suture moves the first retainer toward the covering member.
• The device may further comprise a second retainer movable toward the covering member by pulling a second suture attached to the second retainer. The covering member can have a second opening configured to restrict movement of the second suture. In preferred embodiments, the first and second retainers are spherical.
• In preferred embodiments, the first and second retainers and the first and second sutures are composed of a resorbable material.
• In a preferred embodiment, the retainers are positioned in a substantially side by side relationship in a placement position and are positioned in a stacked relationship in a delivery position.
• In one embodiment, the opening has a dimension to frictionally engage the connecting member. In another embodiment, the opening includes a plurality of teeth to retain the connecting member.
• The covering member is preferably pivotable between a longitudinal orientation for delivery and a transverse position for placement
• The device may include a third opening for unrestricted movement of the first suture and fourth opening for unrestricted movement of the second suture.
• In another aspect, the present disclosure provides a method of closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall. The method comprises the steps of:
• • inserting a covering member inside the vessel against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture and having a connecting member extending therefrom;
  • inserting a first retainer external of the vessel; and
  • applying a sufficient force to overcome resistance to movement of the connecting member to advance the first retainer toward the covering member.
• In one embodiment, the step of advancing the first retainer comprises the step of moving a suture attached to the first retainer through an opening in the covering member having a diameter substantially the same as the outer diameter of the suture. The method preferably includes the steps of inserting a second retainer external of the vessel and advancing the second retainer toward the covering member by pulling a second suture connected to the second retainer.
• In one embodiment, the step of advancing the first retainer comprises the step of moving a first suture attached to the first retainer through an opening having a plurality of teeth engagable with the outer surface of the suture. In another embodiment, the step of advancing the first retainer comprises the step of moving a first suture attached to the first retainer between bumps on the covering member.
BRIEF DESCRIPTION OF THE DRAWINGS
• Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
• FIG. 1 is a perspective view of a first embodiment of the closure device of the present invention;
• FIG. 2 is a side perspective view of the covering (blocking) member of the closure device ofFIG. 1 shown within a delivery sheath;
• FIG. 3 is a side perspective view illustrating the covering member ofFIG. 2 deployed from the delivery sheath;
• FIG. 4 is a side view illustrating one of the spherical retainers of the closure device deployed from the sheath (the vessel wall shown in cross-section);
• FIG. 5 illustrates both spherical retainers deployed from the sheath;
• FIG. 6 illustrates the sutures pulled to move the spherical retainers toward the covering member for positioning in a side by side relationship against the outer surface of the vessel wall;
• FIG. 7 is a perspective view illustrating the retainers in the placement position;
• FIG. 8 is a perspective view of the covering member and sutures of an alternate embodiment of the closure device of the present invention showing the sutures attached to the covering member via a looped suture;
• FIG. 9 is a perspective view illustrating an alternate orientation of the retainers in the placement position;
• FIG. 10 is a perspective view of another alternate embodiment of the closure device of the present invention;
• FIGS. 11-13C illustrate schematically the steps of insertion of the closure device ofFIG. 10 (the delivery sheath not shown for clarity) wherein:
• FIG. 11 illustrates the covering member distal of the retainer tube and the retainers inside the retainer tube;
• FIG. 12 illustrates the retainers advanced from the retainer tube;
• FIG. 13A illustrates the first retainer being advanced towards the covering member;
• FIG. 13B illustrates the first retainer further advanced toward the covering member;
• FIG. 13C illustrates the second retainer advanced toward the covering member;
• FIG. 14 is a perspective of yet another alternate embodiment of the closure device of the present invention;
• FIG. 15 is a cross-sectional view taken along lines15-15 ofFIG. 14;
• FIG. 16 is a bottom view of the covering member ofFIG. 14;
• FIG. 17 is a top view of a portion of the covering member ofFIG. 14 with the suture removed for clarity;
• FIG. 18 is a cross-sectional view taken along lines18-18 ofFIG. 17;
• FIG. 19 is a perspective view of yet another alternate embodiment of the closure device of the present invention;
• FIG. 20 is an exploded view of the spherical retainers and sutures ofFIG. 19;
• FIG. 21 is a cross-sectional view taken along lines21-21 ofFIG. 19;
• FIG. 22 is a cross-sectional view of a region of a covering member of an alternate embodiment of the present invention;
• FIG. 23 is a close up view of the area of detail designated inFIG. 22;
• FIG. 24 is a perspective view of another alternate embodiment of the closure device shown with the covering member plug separated from the covering member;
• FIG. 25 is a perspective view of the assembled closure member ofFIG. 24;
• FIG. 26 is a top view of a region of the covering member of an alternative embodiment;
• FIG. 27 is a bottom view of a region of the covering member of another alternative embodiment;
• FIG. 28 is a perspective view of an alternate embodiment of the closure device of the present invention;
• FIG. 29 is a side view of the closure device ofFIG. 28;
• FIG. 30 is a bottom view of the closure device ofFIG. 28;
• FIG. 31 is a cross-sectional view of the covering member of the closure device ofFIG. 28;
• FIG. 32 is a cross-sectional view illustrating attachment of the retainer and suture;
• FIG. 33 is a cross-sectional view illustrating an alternate attachment of the retainer and suture;
• FIG. 34 is a cross-sectional view illustrating another alternate attachment of the retainer and suture; and
• FIG. 35 is a perspective view of another alternate embodiment of the closure device of the present invention utilizing the retainer/suture attachment ofFIG. 34.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views,FIG. 1 is a perspective view of a first embodiment of the vascular hole (aperture) closure device of the present invention. The device is intended to close an aperture in the vessel wall, typically formed after removal of a catheter previously inserted through the vessel wall into the vessel lumen for performing angioplasty or other interventional procedures. The aperture extends through the patient's skin and underlying tissue, through the external wall of the vessel, through the wall of the vessel, and through the internal wall of the vessel to communicate with the internal lumen of the vessel. The closure device of the present invention has an intravascular component to block blood flow and an extravascular component to retain the intravascular component.
• More specifically, the closure device includes a covering member or patch positioned within the vessel against the internal wall of the vessel to block blood flow and two retainers positioned external of the vessel wall to retain the covering member in its blocking position. Each retainer is preferably spherical in configuration and is fixedly attached to a suture such that pulling of the suture advances the attached retainer toward the covering member to ultimately position the retainers in a side by side relationship either against or adjacent the external surface of the vessel wall.
• Turning toFIGS. 1-7, a first embodiment of the closure device of the present invention is illustrated. Hole (aperture)closure device10 has a covering (blocking) member orpatch40 and first andsecond retainers20,22. First andsecond retainers20,22 are preferably in the form of a sphere or ball. The coveringmember40 is dimensioned and configured for positioning inside the vessel on the internal side of the vessel aperture against the internal wall of the vessel; theretainers20,22 are configured to be positioned outside the vessel wall adjacent or contiguous the external side of the vessel aperture.
• Coveringmember40, preferably elongated in configuration as shown, is retained in a delivery sheath in a longitudinal position for delivery to the vessel, and then pivots to a transverse position within the vessel lumen (substantially perpendicular to an axis extending through the aperture) for orientation to cover (patch) the vessel aperture on the internal side. This movement is illustrated in FIGS. 37A-37D of U.S. Pat. No. 7,662,161, the entire contents of which are incorporated herein by reference (hereinafter the '161 patent). A comparison ofFIGS. 2 and 5 also shows pivoting of the covering member.
• The spherical retainers are preferably held in the delivery tube in a stacked relationship (see e.g.FIG. 11), with retainer22 (222) atop retainer20 (220) (or vice versa).
• The elongated coveringmember40 functions to cover (patch) the internal opening in the vessel wall to prevent the egress of blood. With reference toFIGS. 1 and 4, the coveringmember40 is preferably somewhat oval shaped with elongated substantiallyparallel side walls42a,42band endwalls44a,44bconnecting theside walls42a,42b. Other shapes of the covering member are also contemplated. Theend walls44a,44bcan have substantially straight wall portions, or curved wall portions. Covering member preferably has athicker region43 in the central region than the first andsecond end regions45,47. Other dimensions are also contemplated.
• The longitudinal axis of coveringmember40 defines a lengthwise dimension and transverse axes define a shorter widthwise dimensions. The widthwise dimension of the coveringmember40 is preferably, for a 6Fr device, in the range of about 2.5 mm to about 3.5 mm, and more preferably about 3.3 mm. Other dimensions are also contemplated. The width preferably is at least substantially equal to the dimension of the internal opening in the vessel wall to effectively cover the opening. In a preferred embodiment, the coveringmember40 has a length in the range of about 7.5 mm to about 9 mm (in a 6 French system), and preferably about 8 mm.
• It should be appreciated that alternatively the covering member could be provided with an enlarged width region as illustrated in the embodiment of FIG. 1 of the '161 patent. The covering member could also be configured asymmetrically so that the enlarged region is off-centered to accommodate widening of the aperture as the member is pulled at an angle. The covering member could also be configured in a paddle shaped with a narrowed region adjacent a wider region as in FIGS. 9B-9E of the '161 patent. Other covering member configurations including those disclosed in the '161 patent could be utilized with the retainers of this present application.
• The elongated covering member can be composed of materials such as polycarbonate or polyurethane. Preferably it is composed of resorbable materials such as lactide/glycolide copolymers that after a period of time resorb in the body. If composed of resorbable material, the covering member could optionally have regions of varying resorbability. Varying degrees of resorbability can be achieved for example by utilizing different materials having differing resorbable characteristics or by varying the mass of the covering member (increased mass increases resorbtion time).
• Spherical retainers20 and22 are preferably composed of resorbable material. In a preferred embodiment, the diameter of eachretainer20,22 is about 0.090 inches to about 0.095 inches, although other dimensions are contemplated. Although shown as spheres, other rounded shapes are also contemplated. The retainers could alternatively be made of non-absorbable polymeric or metallic material.
• When theretainers20 and22 are released from the delivery instrument, they are spaced further from the coveringmember40. They are then configured to be advanced toward the coveringmember40. More specifically, eachretainer20,22 is fixedly secured to a respective flexible connecting member such assuture30,32.Sutures30,32 are preferably made of polymeric material and are preferably resorbable, composed of a material such as polydioxanome. It is also contemplated that alternatively a metallic material could be utilized. The sutures, retainers and covering member can be made of the same or different resorbable material, and/or have the same or different resorption times.
• As shown,suture30 has afree end30aand anopposite end30bsecured toretainer20 by molding, gluing, forming a knot, or other methods. Similarly,suture32 has afree end32aand anopposite end32bsecured toretainer22 in any of the foregoing manners. The suture is shown in the embodiment ofFIG. 1 looped through the covering member. Other methods of attachment are also contemplated. For example, in the alternative embodiment ofFIG. 8,sutures150,152 are attached to coveringmember140 by a loop ofsuture160.Loop160 extends upwardly (proximally) from the coveringmember140 and thesutures150,152 are looped throughsuture loop160. Suture160 can be attached to the coveringmember140 by various methods such as insert molding or by tying a knot in the suture under the covering member. In another alternate embodiment shown inFIG. 24,sutures180,182 are insert molded to aplug190. The coveringmember192 has arecess194 to receive theplug190. During manufacture, theplug190 is wedged within therecess194, creating a tight frictional fit. Theplug190 is preferably flush with thedistal surface195 of coveringmember192. Spherical retainers are designated byreference numerals187,188, are preferably identical toretainers20,22, and illustrated in the advanced position closer toproximal surface197 of coveringmember192.
• To advance theretainers20,22 toward the vessel wall (and covering member), the free end of each suture is pulled proximally (in a direction of the arrow ofFIG. 4, thereby moving the respective retainer in the opposite direction closer to the aperture A and vessel wall W. Once tightened against the tissue, a sufficient retention force is maintained, i.e. a proximal pulling force on the coveringmember40 to pull it slightly proximally against the vessel wall. Theretainers20,22 therefore help to prevent the coveringmember40 from separating from the vessel wall (e.g. moving in the direction toward the opposing vessel wall) which could create an unwanted gap between the coveringmember40 and the vessel opening to allow blood flow. The extent to which theretainers20,22 move toward the wall (and thus their distance from the vessel wall in their final placement position) will depend on the tissue thickness. Thus, the closure device can adjust for different tissue thicknesses and apply a constant retention force regardless of tissue thickness. The retainers of the other embodiments disclosed herein function in a similar manner.
• The delivery instrument for inserting the closure device extends through an opening in the skin, through the tissue tract to the vessel, through an external opening in the vessel wall, through the aperture in the vessel wall, and through an internal opening on the internal side of the vessel wall into the vessel lumen.
• The coveringmember40 inFIG. 2 isoutside retainer tube50 and, withindelivery sheath60 in a tilted (pivoted) position. The coveringmember40 emerges from thesheath60 and moves from a tilted position, more aligned or in preferred embodiments substantially aligned with the longitudinal axis of the sheath, to a transverse position within the vessel (seeFIG. 3). (Note the vessel wall is shown inFIG. 3 but the rest of the vessel and tissue are removed for clarity.) Theretainers20,22 remain withintube50. Note the coveringmember40 can be ejected by a pusher (not shown) contacting the side or top wall. The retainers/covering members of the other embodiments disclosed herein can be delivered in a similar manner as that ofretainers20,22 and coveringmember40.
• As shown inFIG. 4 coveringmember40 is pulled proximally to abut the internal opening on the internal side of the vessel W to cover (patch) the opening and the sutures extend through the opening A in the vessel wall. Thefirst retainer20 is shown ejected from thedelivery sheath60 inFIG. 4 either by advancing the retainer, retracting the sheath after a counterforce is applied by engagement of the covering member with the vessel wall, or relative movement of both. Thesecond retainer22 is still withintube50. Thesecond retainer22 is then deployed in a similar manner asretainer20 and is shown outsidesheath60 inFIG. 5. Note that in the delivery position, theretainers20 and22 are preferably in a stacked relationship (such as inFIG. 11) to minimize the transverse dimension of the delivery system.
• Then, to retain the coveringmember40 in position against the vessel wall to block blood flow therethrough, sutures30 and32 are pulled proximally from their free ends30a,32ain the direction of arrows B ofFIG. 6, thereby advancing theretainers20,22 distally in the direction of arrows C toward the vessel wall V and coveringmember40. As shown, theretainers20,22 can be moved to a position contiguous to the vessel wall, or depending on tissue thickness, may be adjacent the wall with some tissue interposed between the retainers and vessel wall. Theretainers20,22 in this position apply a proximal force on the elongated coveringmember40 to limit movement of the covering member into the vessel. The retainers in this placement position are preferably in a substantially side by side relationship as shown inFIG. 7.
• As shown inFIG. 7, in the side by side relationship, theretainers20 and22 are alongside in a transverse orientation with respect to coveringmember40. That is, they are positioned along the width of the coveringmember40. However it is also contemplated that the retainers in the placement position can be in a lengthwise orientation (substantially parallel to the longitudinal axis of the covering member) as shown inFIG. 9 where corresponding components toFIG. 7 (e.g. retainers20′,22′, sutures30′,32′, coveringmember40′) have prime designations. The retainers could also be in other side by side arrangements at angles to the longitudinal axis. Alternatively, the retainers can be partially stacked in the placement position.
• FIG. 10 illustrates an alternate embodiment of the closure device, designated byreference numeral200. Closure device is substantially identical to closure device ofFIG. 1 except for the knot at the end of the suture to retain the suture. More specifically,suture232 has a free end232aand a knottedend232bwith aknot236 to retainspherical retainer222. Similarly,suture240 has afree end240aand a knottedend240bwith aknot246 to retainspherical retainer220. The sutures are held in frictional engagement with a bore extending through therespective retainer220,222. Coveringmember290 is substantially identical to coveringmember40 ofFIG. 1 with the sutures attached thereto by a loop (not shown) as inFIG. 1. As the suture free ends240a,232aare pulled, the respectivespherical retainers220,222 are advanced toward the coveringmember240, as theknots246,236 abut the proximal end of the respectivespherical retainers220 and222. Thus, the knots aid in the attachment ofretainers220,222.
• FIGS. 11-13C illustrate schematically a delivery system which can be utilized for placement of the closure devices described herein and shows schematically the device ofFIG. 10 by way of example.
• The delivery device includes aretainer tube350 which is positioned within a delivery sheath (not shown).Retainer tube350 has adistal opening352 communicating withlumen354 providing for passage of theretainers220,222 ofclosure device200. Also positioned within thedelivery tube350 is apusher tube360 which is preferably solid except for two small lumens (not shown) dimensioned to receive arespective suture240,232.
• In use, theretainer tube350 with the retainers of the closure device contained within is placed in a delivery sheath (not shown). When positioned within the delivery sheath, theretainers220,222 are contained within thelumen352 and the coveringmember290 is positioned outside theretainer tube350, and held in a longitudinal position by the walls of the delivery sheath. The coveringmember290 is advanced from the delivery sheath into the vessel lumen by advancing thepusher tube360 against thesecond retainer222 in the direction of the arrow ofFIG. 11. Since in the delivery position thesecond retainer222 abuts thefirst retainer220 which abuts the coveringmember290, advancement of thepusher tube360 advances the coveringmember290 from the delivery sheath.
• Subsequently, thepusher tube360 is moved further distally to advance theretainers220,222 from theretainer tube350 as shown inFIG. 12. Next, thefirst retainer220 is advanced toward the covering member as shown inFIGS. 13A,13B by pulling thesuture240 from its proximal end in the direction of the arrow. After placement of thefirst retainer220, thesecond suture232 is pulled proximally in the direction of the arrow ofFIG. 13C to advance thesecond retainer222 toward the coveringmember290. The sutures can then be severed leaving theretainers220,222 and coveringmember290 in place. It should be appreciated that these schematic views ofFIGS. 11-13C omit the surrounding tissue and vessel portions for clarity. The coveringmember290 is positioned inside the vessel lumen and thespherical retainers220,222 are positioned outside the vessel lumen.
• FIGS. 14-18 illustrate an alternate embodiment of the closure device having a configuration to restrict movement of the connecting member, e.g. the suture, which connects the retainer to the covering member.
• More specifically, theclosure device400 ofFIG. 14 is similar to thedevice200 ofFIG. 10 except the coveringmember490 has a first pair ofholes494a,494band a second pair ofholes496a,496b. The first pair ofholes494a,494breceivesuture440 and the second pair ofholes496a,496breceivesuture430.Holes494a,496ahave a smaller diameter thanholes494b,496b. Thelarger hole494bis dimensioned to receivesuture440 for free unrestricted movement of thesuture440 therethrough and therefore easier application ofspherical retainer420. Similarly, thelarger hole496bis dimensioned to receivesuture430 for free unrestricted movement of thesuture430 therethrough and therefore for easier application (movement) ofspherical retainer422.Smaller hole496ais dimensioned to frictionally engagesuture430 so that tension is applied to thesuture430. It is dimensioned so that thesuture430 can be pulled through thehole496aif sufficient force is applied by pulling onfree end430a, but if such predetermined force is not applied, the suture will remain frictionally engaged within the wall of the opening496aand not move. In this manner, when the user ceases pulling onfree end430a, thesuture430 and thus thespherical retaining ball422 will remain in position.Suture440 operates in a similar manner, with smaller opening494adimensioned to frictionally engage and resist movement of thesuture440 to retainspherical retainer420.FIGS. 15-18 show how the suture is looped through the respective opening.
• In an alternate embodiment, a plurality of internal teeth can be provided to enhance the retention of the suture within the smaller diameter hole. This is shown for example inFIGS. 22 and 23 whereinhole496a′ has a plurality ofteeth497 formed on the interior wall of the smaller opening. Engagement of thesuture430′ by theteeth497 retains thesuture430 and spherical retainer. Note that theteeth497 can be formed to angle inwardly so thesuture430 can be moved in only one direction, i.e. proximally so the retainer is advanced toward the covering member. Similar teeth can be provided in the other small hole for retaining the other suture and retainer.
• In the embodiment ofFIG. 26, theopening522 in coveringmember520 has a triangularwedge shape region523. Theregion523 has a reduced size opening, narrowing to a diameter less than an outer diameter of thesuture530 extending therethrough. The clinician can move thesuture530 into the narrow (reduced diameter)region523 when desired to apply a gripping force on thesuture530 to retain the suture in place.Opening524 is dimensioned larger than the outer diameter of thesuture530 to allow free unrestricted movement therethrough. Only one of the pair of openings is shown in the portion of the coveringmember520 illustrated inFIG. 26, it being understood that a second similar pair of openings for the second suture can be provided. In all other respects the closure device can be identical toclosure device200 ofFIG. 10 or other devices disclosed herein.
• In the embodiment ofFIG. 27, the retention of the suture is enhanced by inwardly directedbumps560a,560b,560cand560don the underside of the coveringmember570. That is, the suture (not shown) extending through large andsmall openings570,572, respectively, is gripped by thebumps560a,560bas the distance between opposing bumps is slightly less than the diameter of the suture. Sufficient tension (e.g. pulling force by the clinician), overrides the frictional force of the bumps560 on the suture. Similarly a suture (not shown) extending through large andsmall openings574,576 is frictionally restrained bybumps560c,560d. The sutures connect retainers to the coveringmember550 and are configured to be pulled to advance the retainers to the covering member in the manner described above with respect to the other embodiments. The bumps560 can be utilized as a supplement to the small opening frictional engagement as is the embodiment ofFIG. 14 or alternatively as the sole retention feature with two pairs of larger openings in the covering member.
• FIGS. 19-21 illustrate an alternate embodiment of the closure device, designated generally byreference numeral600, having asuture610 extending transversely and joiningspherical retainers620 and622. Aknot610a,610bis formed on each end of thesuture610 to retain theretainers620,622. Connectingsuture630 has a loopedproximal end632 through which suture610 extends. Thisloop632 is tightened to securesuture610. Both ends631,632 of the loopedsuture630 extend thoughfirst opening641 in coveringmember640.End632 terminates inknot633 to connectsuture630 to covering member640 (due to its diameter larger than opening641). Theother end637 loops through coveringmember640, exiting throughopening642 insuture portion635.Openings642,641 can be large and small openings functioning similar to the large and small openings of the embodiment ofFIG. 14. That is, the openings can be configured to provide for free movement and tighter frictional engagement as in the embodiment ofFIG. 14.
• Pulling ofsuture end630aadvances theretainers620,622 together toward the coveringmember640 due to the engagement ofsuture630 with thetransverse suture610.
• FIGS. 28-31 illustrate an alternate embodiment of the closure device, designated generally byreference numeral700.Device700 is similar todevice400 except for the way the suture and retainer are attached and the suture openings in the covering member. More specifically,closure device700 has afirst suture730 and asecond suture740.Retainer722, preferably spherical in configuration, is connected to suture730 andretainer720, preferably spherical, is connected to suture740.
• Coveringmember790 has a first pair ofholes794a,794band a second pair ofholes796a,796b. The first pair ofholes794a,794breceivesuture740 and the second pair ofholes796a,796breceivesuture730.Holes794a,796ahave a smaller diameter thanholes794b,796b. Thelarger hole794bis dimensioned to receivesuture740 for free unrestricted movement of thesuture740 therethrough and therefore easier application ofspherical retainer720. Similarly, thelarger hole796bis dimensioned to receivesuture730 for free unrestricted movement of thesuture730 therethrough and therefore for easier application (movement) ofspherical retainer722.
• Smaller hole796ais dimensioned to frictionally engagesuture730 so that tension is applied to thesuture730. It is dimensioned so that thesuture730 can be pulled through thehole796aif sufficient force is applied by pulling onfree end730a, but if such predetermined force is not applied, the suture will remain frictionally engaged within the wall of the opening796aand not move. As shown in the cross-sectional view ofFIG. 31, thehole796ahas an inwardlyangled wall797 transitioning into a reduceddiameter region798 and an outwardly angled wall799 transitioning back to a larger diameter. Theangled walls797,799 facilitate movement of thesuture730 when tension is applied, with the reduceddiameter region798 frictionally securing the suture. Hole794ahas a similar configuration ashole796aand thus contains similar angled walls. In this manner, when the user ceases pulling onfree end730a, thesuture730 and thus thespherical retaining ball722 will remain in position.Suture740 operates in a similar manner, with smaller opening794adimensioned to frictionally engage and resist movement of thesuture740 to retainspherical retainer720.
• FIG. 32 illustrates one method of attachment of the suture to a spherical retainer.Spherical retainer720 has a throughhole721 extending therethrough.Hole721 has afirst portion721ahaving a first diameter and asecond portion721bhaving a second larger diameter. A crimp or abead743 is attached to thesuture740, creating a diameter larger than the diameter ofportion721a. Thus, the wall of the throughhole721 forms ashoulder723 to block movement of thespherical retainer720. Preferably, theend741 of the suture is substantially flush with thespherical retainer720. The crimp or bead is of substantial transverse dimension to frictionally engage thesecond portion721b. Consequently, this frictional engagement prevents theretainer720 from sliding in the direction away from the coveringmember790 while theshoulder723 prevents theretainer720 from sliding in the direction toward the coveringmember790. Theretainer722 andsuture730 preferably have the same structure and engagement/retention asretainer722 andsuture740.
• In the alternate embodiment ofFIG. 33, thesuture740′ has aknot747 formed at its end. Theshoulder723′ provides a stop for movement ofretainer720′ away from coveringmember790′, as the diameter ofportion721a′ ofopening721 is less than the transverse dimension of theknot747. Theknot747 is of sufficient transverse dimension to frictionally engage thesecond portion721b′ to prevent theretainer720′ from sliding in the direction away from the coveringmember790.
• In the embodiment ofFIGS. 34 and 35, asuture834 forming aloop835 has aknot837 at one end. Thissuture knot837 frictionally engagesportion821bof thehole821 formed in theretainer820. A reduced diameter hole portion821aforms ashoulder823 to block movement of theknot837. As shown, the loopedend835 ofsuture834 receivessuture830. Consequently, tension applied to theends830aofsuture830 pull theloop835 upwardly (as viewed in the orientation of theFIG. 35) away from the coveringmember890 to advancespherical retainer member822 toward the coveringmember890. Asecond suture854 identical tosuture834 has a loop to receivesuture840 in the same manner assuture830.Suture854 and840 are identical tosutures834 and830, respectively, except that they function to secure and movespherical retainer member820. Consequently, when the ends840aofsuture840 are pulled proximally, thesuture854, attached within an opening in theretainer820 in the identical manner assuture834, pulls theretainer820 toward the coveringmember890.
• While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.

Claims (20)

1. A device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the device comprising:

a covering member positionable inside the vessel against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture, the covering member having a first opening;

a first retainer positionable external of the vessel; and

a flexible connecting member operatively connecting the covering member and the first retainer, the connecting member advancing the first retainer toward the covering member, the first opening of the covering member configured to restrict movement of the connecting member.

2. The device ofclaim 1, wherein the connecting member comprises a first suture, and the first retainer is attached to the suture.

3. The device ofclaim 2, wherein pulling of the first suture moves the first retainer toward the covering member.

4. The device ofclaim 3, wherein the first retainer is spherical in configuration.

5. The device ofclaim 1, further comprising a second retainer movable toward the covering member.

6. The device ofclaim 5, further comprising a second flexible connecting member, the second retainer attached to the second suture and pulling of the second connecting member advances the second retainer toward the covering member, the covering member having a second opening configured to restrict movement of the connecting member.

7. The device ofclaim 6, wherein the second retainer is spherical in configuration.

8. The device ofclaim 1, wherein the covering member is composed of a polymeric material.

9. The device ofclaim 1, wherein the covering member and first retainer are composed of a resorbable material.

10. The device ofclaim 2, further comprising a second suture and second retainer attached to the second suture, the second suture advancing the second retainer toward the covering member.

11. The device ofclaim 10, wherein the first and second retainers are positioned in a substantially side by side relationship in a placement position and are positioned in a stacked relationship in a delivery position.

12. The device ofclaim 10, wherein the first and second retainers are in a transverse orientation with respect to the covering member in the placement position.

13. The device ofclaim 10, wherein the first and second retainers and the first and second sutures are composed of a resorbable material.

14. The device ofclaim 1, wherein the first opening of the covering member has a dimension to frictionally engage the connecting member.

15. The device ofclaim 1, wherein the covering member is pivotable between a more longitudinal orientation for delivery and a transverse position for placement.

16. The device ofclaim 10, further comprising a third opening in the covering member for unrestricted movement of the first suture and a fourth opening in the covering member for unrestricted movement of the second suture.

17. A method of closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the method comprising:

inserting a covering member inside the vessel against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture and having a connecting member extending therefrom; and

inserting a first retainer external of the vessel; and

applying a sufficient force to overcome resistance to movement of the connecting member to advance the first retainer toward the covering member.

18. The method ofclaim 18, wherein the step of advancing the first retainer comprises the step of moving a first suture attached to the first retainer through an opening having a diameter substantially the same as the outer diameter of the suture.

19. The method ofclaim 18, further comprising the steps of inserting a second retainer external of the vessel and advancing the second retainer toward the covering member by pulling a second suture connected to the second retainer.

20. The method ofclaim 17, wherein the step of advancing the first retainer comprises the step of moving a first suture attached to the first retainer between bumps on the covering member.

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