US20110029013A1 - Vascular Hole Closure Device - Google Patents
Vascular Hole Closure Device Download PDFInfo
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- US20110029013A1 US20110029013A1 US12/854,988 US85498810A US2011029013A1 US 20110029013 A1 US20110029013 A1 US 20110029013A1 US 85498810 A US85498810 A US 85498810A US 2011029013 A1 US2011029013 A1 US 2011029013A1
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- covering member
- retainer
- suture
- opening
- vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00659—Type of implements located only on one side of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0404—Buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0456—Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0459—Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
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- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Health & Medical Sciences (AREA)
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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.
- 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.
- 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:
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- 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.
- Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
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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 lines 15-15 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 lines 18-18 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 lines 21-21 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 . - 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 to
FIGS. 1-7 , a first embodiment of the closure device of the present invention is illustrated. Hole (aperture)closure device 10 has a covering (blocking) member orpatch 40 and first andsecond retainers second retainers member 40 is dimensioned and configured for positioning inside the vessel on the internal side of the vessel aperture against the internal wall of the vessel; theretainers - Covering
member 40, 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 retainer 22 (222) atop retainer 20 (220) (or vice versa). - The elongated covering
member 40 functions to cover (patch) the internal opening in the vessel wall to prevent the egress of blood. With reference toFIGS. 1 and 4 , the coveringmember 40 is preferably somewhat oval shaped with elongated substantiallyparallel side walls 42 a, 42 b and endwalls 44 a, 44 b connecting theside walls 42 a, 42 b. Other shapes of the covering member are also contemplated. Theend walls 44 a, 44 b can have substantially straight wall portions, or curved wall portions. Covering member preferably has athicker region 43 in the central region than the first andsecond end regions - The longitudinal axis of covering
member 40 defines a lengthwise dimension and transverse axes define a shorter widthwise dimensions. The widthwise dimension of the coveringmember 40 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 coveringmember 40 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 retainers retainer - When the
retainers member 40. They are then configured to be advanced toward the coveringmember 40. More specifically, eachretainer suture Sutures - As shown,
suture 30 has afree end 30 a and anopposite end 30 b secured toretainer 20 by molding, gluing, forming a knot, or other methods. Similarly,suture 32 has afree end 32 a and anopposite end 32 b secured toretainer 22 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 ,sutures member 140 by a loop ofsuture 160.Loop 160 extends upwardly (proximally) from the coveringmember 140 and thesutures suture loop 160. Suture 160 can be attached to the coveringmember 140 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 ,sutures plug 190. The coveringmember 192 has arecess 194 to receive theplug 190. During manufacture, theplug 190 is wedged within therecess 194, creating a tight frictional fit. Theplug 190 is preferably flush with thedistal surface 195 of coveringmember 192. Spherical retainers are designated byreference numerals retainers proximal surface 197 of coveringmember 192. - To advance the
retainers FIG. 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 coveringmember 40 to pull it slightly proximally against the vessel wall. Theretainers member 40 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 coveringmember 40 and the vessel opening to allow blood flow. The extent to which theretainers - 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 covering
member 40 inFIG. 2 isoutside retainer tube 50 and, withindelivery sheath 60 in a tilted (pivoted) position. The coveringmember 40 emerges from thesheath 60 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.) Theretainers tube 50. Note the coveringmember 40 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 ofretainers member 40. - As shown in
FIG. 4 coveringmember 40 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 retainer 20 is shown ejected from thedelivery sheath 60 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 retainer 22 is still withintube 50. Thesecond retainer 22 is then deployed in a similar manner asretainer 20 and is shown outsidesheath 60 inFIG. 5 . Note that in the delivery position, theretainers FIG. 11 ) to minimize the transverse dimension of the delivery system. - Then, to retain the covering
member 40 in position against the vessel wall to block blood flow therethrough, sutures 30 and 32 are pulled proximally from their free ends 30 a, 32 a in the direction of arrows B ofFIG. 6 , thereby advancing theretainers member 40. As shown, theretainers retainers member 40 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 in
FIG. 7 , in the side by side relationship, theretainers member 40. That is, they are positioned along the width of the coveringmember 40. 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. retainers 20′, 22′, sutures 30′, 32′, coveringmember 40′) 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 numeral 200. 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,suture 232 has a free end 232 a and a knottedend 232 b with aknot 236 to retainspherical retainer 222. Similarly,suture 240 has afree end 240 a and a knottedend 240 b with aknot 246 to retainspherical retainer 220. The sutures are held in frictional engagement with a bore extending through therespective retainer member 290 is substantially identical to coveringmember 40 ofFIG. 1 with the sutures attached thereto by a loop (not shown) as inFIG. 1 . As the suture free ends 240 a, 232 a are pulled, the respectivespherical retainers member 240, as theknots spherical retainers retainers -
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 a
retainer tube 350 which is positioned within a delivery sheath (not shown).Retainer tube 350 has adistal opening 352 communicating withlumen 354 providing for passage of theretainers closure device 200. Also positioned within thedelivery tube 350 is apusher tube 360 which is preferably solid except for two small lumens (not shown) dimensioned to receive arespective suture - In use, the
retainer tube 350 with the retainers of the closure device contained within is placed in a delivery sheath (not shown). When positioned within the delivery sheath, theretainers lumen 352 and the coveringmember 290 is positioned outside theretainer tube 350, and held in a longitudinal position by the walls of the delivery sheath. The coveringmember 290 is advanced from the delivery sheath into the vessel lumen by advancing thepusher tube 360 against thesecond retainer 222 in the direction of the arrow ofFIG. 11 . Since in the delivery position thesecond retainer 222 abuts thefirst retainer 220 which abuts the coveringmember 290, advancement of thepusher tube 360 advances the coveringmember 290 from the delivery sheath. - Subsequently, the
pusher tube 360 is moved further distally to advance theretainers retainer tube 350 as shown inFIG. 12 . Next, thefirst retainer 220 is advanced toward the covering member as shown inFIGS. 13A , 13B by pulling thesuture 240 from its proximal end in the direction of the arrow. After placement of thefirst retainer 220, thesecond suture 232 is pulled proximally in the direction of the arrow ofFIG. 13C to advance thesecond retainer 222 toward the coveringmember 290. The sutures can then be severed leaving theretainers member 290 in place. It should be appreciated that these schematic views ofFIGS. 11-13C omit the surrounding tissue and vessel portions for clarity. The coveringmember 290 is positioned inside the vessel lumen and thespherical retainers -
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, the
closure device 400 ofFIG. 14 is similar to thedevice 200 ofFIG. 10 except the coveringmember 490 has a first pair ofholes 494 a, 494 b and a second pair ofholes holes 494 a, 494 b receivesuture 440 and the second pair ofholes suture 430.Holes 494 a, 496 a have a smaller diameter thanholes larger hole 494 b is dimensioned to receivesuture 440 for free unrestricted movement of thesuture 440 therethrough and therefore easier application ofspherical retainer 420. Similarly, thelarger hole 496 b is dimensioned to receivesuture 430 for free unrestricted movement of thesuture 430 therethrough and therefore for easier application (movement) ofspherical retainer 422.Smaller hole 496 a is dimensioned to frictionally engagesuture 430 so that tension is applied to thesuture 430. It is dimensioned so that thesuture 430 can be pulled through thehole 496 a if sufficient force is applied by pulling onfree end 430 a, but if such predetermined force is not applied, the suture will remain frictionally engaged within the wall of the opening 496 a and not move. In this manner, when the user ceases pulling onfree end 430 a, thesuture 430 and thus thespherical retaining ball 422 will remain in position.Suture 440 operates in a similar manner, with smaller opening 494 a dimensioned to frictionally engage and resist movement of thesuture 440 to retainspherical retainer 420.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 in
FIGS. 22 and 23 whereinhole 496 a′ has a plurality ofteeth 497 formed on the interior wall of the smaller opening. Engagement of thesuture 430′ by theteeth 497 retains thesuture 430 and spherical retainer. Note that theteeth 497 can be formed to angle inwardly so thesuture 430 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 of
FIG. 26 , theopening 522 in coveringmember 520 has a triangularwedge shape region 523. Theregion 523 has a reduced size opening, narrowing to a diameter less than an outer diameter of thesuture 530 extending therethrough. The clinician can move thesuture 530 into the narrow (reduced diameter)region 523 when desired to apply a gripping force on thesuture 530 to retain the suture in place.Opening 524 is dimensioned larger than the outer diameter of thesuture 530 to allow free unrestricted movement therethrough. Only one of the pair of openings is shown in the portion of the coveringmember 520 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 device 200 ofFIG. 10 or other devices disclosed herein. - In the embodiment of
FIG. 27 , the retention of the suture is enhanced by inwardly directedbumps member 570. That is, the suture (not shown) extending through large andsmall openings bumps small openings bumps member 550 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 bumps 560 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 numeral 600, having asuture 610 extending transversely and joiningspherical retainers knot suture 610 to retain theretainers suture 630 has a loopedproximal end 632 through which suture 610 extends. Thisloop 632 is tightened to securesuture 610. Both ends 631, 632 of the loopedsuture 630 extend thoughfirst opening 641 in coveringmember 640.End 632 terminates inknot 633 to connectsuture 630 to covering member 640 (due to its diameter larger than opening 641). Theother end 637 loops through coveringmember 640, exiting throughopening 642 insuture portion 635.Openings FIG. 14 . That is, the openings can be configured to provide for free movement and tighter frictional engagement as in the embodiment ofFIG. 14 . - Pulling of
suture end 630 a advances theretainers member 640 due to the engagement ofsuture 630 with thetransverse suture 610. -
FIGS. 28-31 illustrate an alternate embodiment of the closure device, designated generally byreference numeral 700.Device 700 is similar todevice 400 except for the way the suture and retainer are attached and the suture openings in the covering member. More specifically,closure device 700 has afirst suture 730 and asecond suture 740.Retainer 722, preferably spherical in configuration, is connected to suture 730 andretainer 720, preferably spherical, is connected to suture 740. - Covering
member 790 has a first pair ofholes 794 a, 794 b and a second pair ofholes holes 794 a, 794 b receivesuture 740 and the second pair ofholes suture 730.Holes 794 a, 796 a have a smaller diameter thanholes larger hole 794 b is dimensioned to receivesuture 740 for free unrestricted movement of thesuture 740 therethrough and therefore easier application ofspherical retainer 720. Similarly, thelarger hole 796 b is dimensioned to receivesuture 730 for free unrestricted movement of thesuture 730 therethrough and therefore for easier application (movement) ofspherical retainer 722. -
Smaller hole 796 a is dimensioned to frictionally engagesuture 730 so that tension is applied to thesuture 730. It is dimensioned so that thesuture 730 can be pulled through thehole 796 a if sufficient force is applied by pulling onfree end 730 a, but if such predetermined force is not applied, the suture will remain frictionally engaged within the wall of the opening 796 a and not move. As shown in the cross-sectional view ofFIG. 31 , thehole 796 a has an inwardlyangled wall 797 transitioning into a reduceddiameter region 798 and an outwardly angled wall 799 transitioning back to a larger diameter. Theangled walls 797, 799 facilitate movement of thesuture 730 when tension is applied, with the reduceddiameter region 798 frictionally securing the suture. Hole 794 a has a similar configuration ashole 796 a and thus contains similar angled walls. In this manner, when the user ceases pulling onfree end 730 a, thesuture 730 and thus thespherical retaining ball 722 will remain in position.Suture 740 operates in a similar manner, with smaller opening 794 a dimensioned to frictionally engage and resist movement of thesuture 740 to retainspherical retainer 720. -
FIG. 32 illustrates one method of attachment of the suture to a spherical retainer.Spherical retainer 720 has a throughhole 721 extending therethrough.Hole 721 has afirst portion 721 a having a first diameter and asecond portion 721 b having a second larger diameter. A crimp or abead 743 is attached to thesuture 740, creating a diameter larger than the diameter ofportion 721 a. Thus, the wall of the throughhole 721 forms ashoulder 723 to block movement of thespherical retainer 720. Preferably, theend 741 of the suture is substantially flush with thespherical retainer 720. The crimp or bead is of substantial transverse dimension to frictionally engage thesecond portion 721 b. Consequently, this frictional engagement prevents theretainer 720 from sliding in the direction away from the coveringmember 790 while theshoulder 723 prevents theretainer 720 from sliding in the direction toward the coveringmember 790. Theretainer 722 andsuture 730 preferably have the same structure and engagement/retention asretainer 722 andsuture 740. - In the alternate embodiment of
FIG. 33 , thesuture 740′ has aknot 747 formed at its end. Theshoulder 723′ provides a stop for movement ofretainer 720′ away from coveringmember 790′, as the diameter ofportion 721 a′ ofopening 721 is less than the transverse dimension of theknot 747. Theknot 747 is of sufficient transverse dimension to frictionally engage thesecond portion 721 b′ to prevent theretainer 720′ from sliding in the direction away from the coveringmember 790. - In the embodiment of
FIGS. 34 and 35 , asuture 834 forming aloop 835 has aknot 837 at one end. Thissuture knot 837 frictionally engagesportion 821 b of thehole 821 formed in theretainer 820. A reduced diameter hole portion 821 a forms ashoulder 823 to block movement of theknot 837. As shown, the loopedend 835 ofsuture 834 receivessuture 830. Consequently, tension applied to theends 830 a ofsuture 830 pull theloop 835 upwardly (as viewed in the orientation of theFIG. 35 ) away from the coveringmember 890 to advancespherical retainer member 822 toward the coveringmember 890. Asecond suture 854 identical tosuture 834 has a loop to receivesuture 840 in the same manner assuture 830.Suture sutures spherical retainer member 820. Consequently, when the ends 840 a ofsuture 840 are pulled proximally, thesuture 854, attached within an opening in theretainer 820 in the identical manner assuture 834, pulls theretainer 820 toward the coveringmember 890. - 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 of claim 1 , wherein the connecting member comprises a first suture, and the first retainer is attached to the suture.
3. The device of claim 2 , wherein pulling of the first suture moves the first retainer toward the covering member.
4. The device of claim 3 , wherein the first retainer is spherical in configuration.
5. The device of claim 1 , further comprising a second retainer movable toward the covering member.
6. The device of claim 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 of claim 6 , wherein the second retainer is spherical in configuration.
8. The device of claim 1 , wherein the covering member is composed of a polymeric material.
9. The device of claim 1 , wherein the covering member and first retainer are composed of a resorbable material.
10. The device of claim 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 of claim 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 of claim 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 of claim 10 , wherein the first and second retainers and the first and second sutures are composed of a resorbable material.
14. The device of claim 1 , wherein the first opening of the covering member has a dimension to frictionally engage the connecting member.
15. The device of claim 1 , wherein the covering member is pivotable between a more longitudinal orientation for delivery and a transverse position for placement.
16. The device of claim 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 of claim 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 of claim 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 of claim 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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US13/085,592 US8920462B2 (en) | 2008-02-15 | 2011-04-13 | Vascular hole closure device |
CA2737628A CA2737628C (en) | 2008-02-15 | 2011-04-19 | Vascular hole closure device |
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US13/274,402 US8491629B2 (en) | 2008-02-15 | 2011-10-17 | Vascular hole closure delivery device |
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US13/935,894 US9339261B2 (en) | 2008-02-15 | 2013-07-05 | Vascular hole closure delivery device |
US13/935,881 US9295458B2 (en) | 2008-02-15 | 2013-07-05 | Vascular hole closure delivery device |
US14/569,670 US9943300B2 (en) | 2008-02-15 | 2014-12-13 | Vascular hole closure device |
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US15/706,660 US20180000471A1 (en) | 2008-02-15 | 2017-09-15 | Vascular hole closure device |
US16/010,487 US11020104B2 (en) | 2008-02-15 | 2018-06-17 | Vascular hole closure delivery device |
US16/138,802 US11369354B2 (en) | 2008-02-15 | 2018-09-21 | Vascular hole closure delivery device |
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US10342524B2 (en) | 2008-02-15 | 2019-07-09 | Rex Medical, L.P. | Vascular hole closure device |
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2010
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- 2010-09-08 EP EP10175821.7A patent/EP2294986B1/en active Active
- 2010-09-08 ES ES10175821T patent/ES2699473T3/en active Active
- 2010-09-10 JP JP2010203129A patent/JP5975454B2/en active Active
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2012
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2016
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- 2016-04-17 US US15/130,996 patent/US10342524B2/en active Active - Reinstated
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2021
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Also Published As
Publication number | Publication date |
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ES2699473T3 (en) | 2019-02-11 |
US20160220237A1 (en) | 2016-08-04 |
US10390808B2 (en) | 2019-08-27 |
EP2294986B1 (en) | 2018-10-24 |
JP5975454B2 (en) | 2016-08-23 |
US20130066364A1 (en) | 2013-03-14 |
US11064986B2 (en) | 2021-07-20 |
US20160228111A1 (en) | 2016-08-11 |
US9463005B2 (en) | 2016-10-11 |
EP2294986A2 (en) | 2011-03-16 |
CA2714250A1 (en) | 2011-03-11 |
US20170020497A1 (en) | 2017-01-26 |
AU2010214638B2 (en) | 2015-09-24 |
JP2011056263A (en) | 2011-03-24 |
CA2714250C (en) | 2020-07-14 |
AU2010214638A1 (en) | 2011-03-31 |
EP2294986A3 (en) | 2017-04-19 |
US20210330307A1 (en) | 2021-10-28 |
US10342524B2 (en) | 2019-07-09 |
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