US20100234885A1 - Patent foramen ovale closure system - Google Patents
Patent foramen ovale closure system Download PDFInfo
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- US20100234885A1 US20100234885A1 US12/791,410 US79141010A US2010234885A1 US 20100234885 A1 US20100234885 A1 US 20100234885A1 US 79141010 A US79141010 A US 79141010A US 2010234885 A1 US2010234885 A1 US 2010234885A1
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- closure device
- foramen ovale
- patent foramen
- wire
- tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
- A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
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Definitions
- Embodiments of the present invention relate to methods and devices for closing a body lumen or cavity and, in particular, for closing a patent foramen ovale.
- Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability. There are over 700,000 strokes per year in the United States alone. Of these, roughly 100,000 are hemorrhagic, and 600,000 are ischemic (either due to vessel narrowing or to embolism). About 50,000 of the ischemic strokes are believed to be caused by a patent foramen ovale. However, the risk of recurrent stroke is higher in patients whose strokes are caused by a patent foramen ovale.
- the heart is divided into four chambers, the two upper being the left and right atria and the two lower being the left and right ventricles.
- the atria are separated from each other by a muscular wall, the interatrial septum, and the ventricles by the interventricular septum.
- abnormal openings, holes or shunts can occur between the chambers of the heart or the great vessels (interatrial and interventricular septal defects or patent ductus arteriosus and aortico-pulmonary window respectively), causing shunting of blood through the opening.
- a patent foramen ovale is a condition wherein an abnormal opening is present in the septal wall between the two atria of the heart. Blood can flow directly between these two atria, compromising the normal flow of blood and efficiency of the patient's heart.
- the deformity is usually congenital, resulting from a failure of completion of the formation of the septum, or wall, between the two sides during fetal life when the heart forms from a folded tube into a four-chambered, two unit system.
- a patent foramen ovale tends to behave like a flap valve. Accordingly, the axis of the patent foramen ovale tends to be at an angle, and almost parallel to the septal wall.
- patent foramen ovale have required relatively extensive surgical techniques for correction.
- the most common method for closing intracardiac shunts such as a patent foramen ovale, entails the relatively drastic technique of open-heart surgery, requiring opening the chest or sternum and diverting the blood from the heart with the use of a cardiopulmonary bypass.
- the heart is then opened, the defect is sewn shut by direct suturing with or without a patch of synthetic material (usually of Dacron, Teflon, silk, nylon or pericardium), and then the heart is closed.
- the patient is then taken off the cardiopulmonary bypass machine, and the chest is closed.
- closures of a patent foramen ovale by means of a mechanical prosthesis have also been disclosed.
- a number of these devices, designed for closures of interauricular septal defects, have been used to correct patent foramen ovale.
- Embodiments of the present invention provide a minimally invasive closure device for closing a patent foramen ovale. Improved delivery and positioning systems are also provided.
- a closure device for closing a patent foramen ovale includes a proximal end, a distal end, a proximal segment, an intermediate segment, and a distal segment, wherein each of the segments is sequentially aligned.
- the device has a generally elongate configuration and a clip configuration. When the device is in its elongate configuration, the proximal and distal ends are pulled away from each other such that the proximal segment, intermediate segment, and distal segment become relatively more linear. When the device is in its clip configuration, the proximal segment and intermediate segment are drawn into a first clip-shaped portion sized and configured to be positioned over a septum secundum of the patent foramen ovale.
- the intermediate segment and distal segment are drawn into a second clip-shaped portion sized and configured to be positioned over a septum primum of the patent foramen ovale.
- the first clip-shaped portion and the second clip-shaped portion provide a force against the septum primum and septum secundum to pinch the two relatively closer together.
- the closure device may be formed from a wire structure, more preferably one integral wire.
- the proximal and distal segments are identical in shape, and may have identical shapes that form mirror images of each other across the patent foramen ovale to equally apply compressive force to both sides of the patent foramen ovale.
- the proximal segment has a larger dimension than the distal segment, and more preferably has both a greater length and width than the distal segment.
- the distal segment may include a pair of wings adapted to extend over the tip of the septum primum.
- the device may also include loops, eyelets or other structure adapted for releasable engagement with a delivery system, as described below.
- the device may also include anchors or other tissue engaging structures to facilitate securement of the device in the patent foramen ovale.
- a closure device for closing a patent foramen ovale includes a proximal segment, a distal segment, and an intermediate segment which may be integrally formed, preferably from an integral wire structure.
- a covering, sleeve or laminate structure is provided on at least one of the segments of the device.
- a sleeve is provided over the intermediate segment and is adapted to be positioned in the tunnel of the patent foramen ovale.
- a laminate structure may be provided over at least the proximal or anterior portion.
- the sleeve may be made of a material that facilitates cellular in-growth, such as ePTFE.
- a method of closing a patent foramen ovale having a septum primum and a septum secundum includes providing a closure device having a proximal end and a distal end and having a generally elongate configuration and a clip configuration. When the device is in its elongate configuration, the proximal and distal ends are pulled away from each other, and when the device is in its clip configuration the device has generally an S-shape. The device is releasably attached relative to a delivery device. The device is then delivered to the patent foramen ovale with the delivery device, the closure device being held relative to the delivery device in its elongate configuration. The closure device is deployed in the patent foramen ovale, such that the device when deployed includes a first clip-shaped portion positioned around the septum secundum and a second clip-shaped portion positioned around the septum primum.
- a method of closing a patent foramen ovale having a septum primum and a septum secundum includes providing a closure device having a proximal end, a distal end, a proximal segment, an intermediate segment and a distal segment. The method further includes deploying the closure device within the patent foramen ovale such that the distal segment lies along a surface of the septum primum within the left atrium of the patient.
- the proximal segment preferably lies along a surface of the septum secundum within the right atrium of the patient.
- the intermediate segment preferably lies in a channel or tunnel between the septum primum and the septum secundum.
- a method of closing a patent foramen ovale includes positioning a closure device at a patent foramen ovale and deploying the closure device, such that the septum primum and septum secundum are secured together by the closure device.
- the closure device is self-expanding and may be releasably engaged with a percutaneous delivery device.
- each of the segments is releasably engaged with the delivery device, such as by extending a core or guidewire through eyelets formed in each of the segments of the device.
- the closure device may be internally or externally threaded to releasably engage a corresponding delivery device. This threading may be provided at the proximal end of the device, at the distal end of the device, or may be provided in proximal, intermediate and/or distal segments.
- the closure device may be delivered through an outer deployment catheter which guides the device to the patent foramen ovale.
- a closure device for closing a patent foramen ovale includes a proximal segment and a distal segment which may be integrally formed.
- the device generally has a hook configuration, wherein the distal segment is sized and configured to be positioned over a septum primum of the patent foramen ovale.
- the proximal segment is sized and configured to extend through the tunnel of the patent foramen ovale, and at its proximal end, may increase in width to form wings to secure the closure device in place.
- the proximal segment is sized and configured to be positioned along a surface of the septum of the patent foramen ovale in the right atrium.
- the device may also include a sleeve or laminate structure between the proximal end and the distal segment, the sleeve or laminate structure adapted to be positioned in the patent foramen ovale tunnel.
- the sleeve or laminate structure is made of material adapted to facilitate cellular in-growth, such as ePTFE.
- a method of closing a patent foramen ovale includes positioning a closure device at a patent foramen ovale and deploying the closure device, such that the septum primum is secured by the closure device.
- the closure device may have wings in a proximal segment thereof that extend beyond the width of the tunnel of the patent foramen ovale. The wings as delivered are positioned in the right atrium against a surface of the septum primum.
- a deployment catheter having a proximal end and a distal end is provided.
- An actuator extends through the deployment catheter.
- a closure device is releasably attached to the actuator.
- the actuator is adapted to advance the closure device from the distal end of the deployment catheter and position a distal segment of the closure device over a septum primum of the patent foramen ovale and position a proximal segment of the closure device over a septum secundum of the patent foramen ovale.
- the closure device is actuatable to pinch together the septum primum and septum secundum once delivered, and may be self-expanding and/or manually actuated. It will also be appreciated that the closure device can be delivered without the deployment catheter, such that the closure device is releasably secured and released from the actuator to deliver the device.
- FIG. 1 is an anterior illustration of a heart, with the proximal parts of the great vessels.
- FIG. 2A is a perspective view of a closure device in accordance with one embodiment the present invention.
- FIG. 2B is a perspective view of a closure device in accordance with one embodiment of the present invention in a delivery state.
- FIG. 3 is a side elevational view of the closure device shown in FIG. 2A .
- FIG. 4 is a cross-sectional view of one of the segments of the closure device shown in FIG. 2A .
- FIG. 4A is an enlarged view of a portion of the segment of FIG. 4 .
- FIG. 5 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 2A , shown schematically.
- FIG. 6 is a perspective view of the closure device of FIG. 2A in a delivery state.
- FIG. 7 is a perspective view of the closure device of FIG. 2A during a deployment state.
- FIG. 8 is a schematic cross-sectional view through the heart with a transeptal catheter deployed at a patent foramen ovale.
- FIG. 9 is a cross-sectional view of the catheter of FIG. 8 through line 9 - 9 .
- FIG. 10 is a partial cross-sectional view of an embodiment of the catheter of FIG. 8 , with a closure device being delivered there through.
- FIG. 11A is a partial cross-sectional view of an embodiment of the catheter of FIG. 8 , with an embodiment of a closure device illustrated being delivered using a torque rod.
- FIG. 11B is an enlarged view of a connecting portion of the closure device shown in FIG. 11A .
- FIG. 11C is a partial cross-sectional view of another embodiment of the catheter of FIG. 8 , with another embodiment of a closure device being delivered there through.
- FIG. 11D is an enlarged view of a distal portion of the closure device shown in FIG. 11C .
- FIGS. 12A-E are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention.
- FIG. 13 is a perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 14 is a perspective view of the closure device of FIG. 13 in a delivery state.
- FIG. 15 is a back elevational view of a closure device in accordance with another embodiment of the present invention.
- FIG. 16 is a side view of the closure device of FIG. 15 .
- FIG. 17 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 15 .
- FIGS. 18A-E are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention.
- FIG. 19A is a front elevational view of a closure device in accordance with another embodiment of the present invention.
- FIG. 19B is a side elevational view of the closure device shown in FIG. 19A .
- FIG. 20 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 19 .
- FIGS. 21A-D are schematic views of a patent foramen ovale closure procedure in accordance with another embodiment of the present invention.
- FIG. 22A is a back view of a closure device in accordance with another embodiment of the present invention.
- FIG. 22B is a back view of a closure device in accordance with another embodiment of the present invention.
- FIG. 22C is a front view of the device of FIG. 22B , showing a laminated structure attached thereto.
- FIG. 23 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 22A or FIG. 22B , shown schematically.
- FIGS. 24A-D are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention, shown inversely to the deployment orientation to facilitate explanation.
- FIG. 25 is a side elevational view of a closure device in accordance with another embodiment of the present invention.
- FIG. 26 is a side elevational view of the closure device of FIG. 25 having a plurality of retention structures.
- FIG. 27 is a rear elevational view of the closure device of FIG. 25 .
- FIG. 28 is a partial cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 25 .
- FIG. 29 is a front elevational view of the closure device of FIG. 25 prior to expansion having a pull wire expansion system.
- FIG. 30 is a front elevational view of the closure device of FIG. 25 after expansion having a pull wire expansion system.
- FIG. 31 is a front elevational view of the closure device of FIG. 25 prior to expansion having a twisting expansion system.
- FIG. 32 is a front elevational view of the closure device of FIG. 25 after expansion having a twisting expansion system.
- FIG. 33 is a schematic side view of a closure device in accordance with another embodiment of the present invention.
- FIG. 34 is an end view of the closure device of FIG. 33 .
- FIG. 35 is a side view of a closure device in accordance with another embodiment of the present invention.
- FIG. 36 is an end view of the closure device of FIG. 35 .
- FIG. 37 is a side view of a closure device in accordance with another embodiment of the present invention.
- FIGS. 38A-B are side schematic views showing the expansion of the closure device of FIG. 37 .
- FIG. 39 is a side view of a closure device in accordance with another embodiment of the present invention.
- FIG. 40 is an end view of the closure device of FIG. 39 .
- FIG. 41 is a side view of the closure device of FIG. 39 in a collapsed state.
- FIG. 42 is a side view of a closure device in accordance with another embodiment of the present invention.
- FIG. 43 is an end view of the closure device of FIG. 42 .
- FIGS. 44A-C are schematic views of a defect closure procedure in accordance with one embodiment of the present invention.
- FIG. 45 is a side view of the closure device of FIG. 42 in a collapsed state.
- FIG. 46 is a perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 47 is a cross-sectional view of a patent foramen ovale closed with a closure device in accordance with another embodiment of the present invention.
- FIG. 48 is a cross-sectional view of a patent foramen ovale closed with a closure device in accordance with another embodiment of the present invention.
- FIG. 49 is a side elevational view of a closure device in accordance with another embodiment of the present invention.
- FIG. 50 is a front view of the closure device of FIG. 49 .
- FIG. 51 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 40 .
- FIG. 52 is a perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 53 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 52 .
- FIG. 54 is a perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 55 is an enlarged perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 56 is a side view of the closure device of FIG. 55 .
- FIG. 57 is a perspective view of a closure device in accordance with another embodiment of the present invention.
- FIG. 58 is a cross-sectional view of a patent foramen ovale closed with the closure device of FIG. 57 .
- FIGS. 59A-C are schematic views of a defect closure procedure in accordance with one embodiment of the present invention.
- a heart 100 is illustrated to show certain portions including the left ventricle 102 , the left atrium 104 , the left atrial appendage 106 , the pulmonary artery 108 , the aorta 110 , the right ventricle 112 , the right atrium 114 , and the right atrial appendage 116 .
- the left atrium 104 is located above the left ventricle 102 and the two are separate by the mitral valve (not illustrated).
- an occlusion or closure device 200 sized and configured to close a patent foramen ovale in accordance with one embodiment of the present invention.
- the closure device preferably comprises a wire shaped to form a clip, which is preferably shaped like a paperclip. As illustrated, in one embodiment the closure device can be considered to have generally an S-shape or two adjacent U-shaped or clip portions, as described further below.
- the closure device 200 has a proximal end 202 and a distal end 204 . The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter, as described below.
- the closure device 200 generally has three sections: a proximal segment 206 , a distal segment 208 , and an intermediate segment 210 . As illustrated in FIG. 4 , each of these segments is preferably generally annular-shaped or oval-shaped forming a loop, and may be generally parallel to each other when the device 200 is in its deployment state, shown in FIG. 2A . It will be appreciated that the segments may have any suitable size and configuration for closing a patent foramen ovale, including round, oblong, rectangular, triangular and square. Each of the segments 206 , 208 , 210 may be formed from wire 212 and may be separately or integrally formed.
- the three segments 206 , 208 , 210 are sequentially aligned such that a distal end 206 b of proximal segment 206 is connected to a proximal end 210 a of intermediate segment 210 , and a distal end 210 b of intermediate segment 210 is connected to a proximal end 208 a of distal segment 208 .
- these segments 206 , 208 , 210 are connected by connecting portions 211 a and 211 b , and may be integrally formed with the connecting portions. Alternatively, they may be joined together by any suitable technique.
- the closure device 200 is also preferably provided with a detachment element 214 at its proximal end 202 , illustrated as an externally threaded portion.
- the proximal end 202 of the device 200 may be provided with a threaded aperture through which a delivery core is threadably engaged, a loop or eyelet, or other suitable structure as will be discussed herein for releasably connecting the device to a deployment system.
- a wire 212 is used to form the segments 206 , 208 and 210 , as well as connecting portions 211 , and comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique.
- the closure device 200 need not be formed from a wire, and can be an integral structure, for example, laser cut from a tube or other stock. It is also envisioned that other non-metallic biocompatible materials may be used to form wire 212 .
- the wire 212 may be solid or hollow.
- the wire 212 is covered with a sleeve 224 .
- the sleeve 224 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for sleeve 224 can be determined through routine experimentation by those of skill in the art.
- the sleeve 224 may be provided on either one or all sections of the closure device. For example, the intermediate segment 210 alone or the entire device 200 may be provided with sleeve 224 . In one embodiment, the sleeve 224 comprises two layers.
- the two layers may be bonded to each other around the wire 212 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the sleeve 224 in one embodiment preferably is securely attached to the device 200 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- the device 200 is illustrated in its deployment state.
- the device 200 may be self-expanding, having a remembered shape as illustrated in FIG. 2A .
- the device 200 may be mechanically actuated to assume its deployment state.
- the device 200 preferably includes a locking element 228 and retention elements, preferably in the form of eyelets 230 , for retaining the locking element 228 to the closure device 200 .
- the eyelets 230 are offset from one another on adjacent segments of the device.
- the eyelets 230 are in line with the longitudinal axis of the device 200 .
- Other details regarding a device having eyelets described above, as well as similar devices, may be found in U.S. Pat. Nos.
- the locking element 228 is used to longitudinally shorten and radially expand the device.
- the locking element 228 preferably comprises a locking string which is preferably used to both longitudinally shorten and radially expand and lock the device at the patent foramen ovale.
- Other details regarding the locking element described above as well as similar devices may be found in U.S. Pat. No. 5,861,003, which is hereby incorporated by reference in its entirety.
- the locking element 228 secures the locking string to retain the device 200 is the deployed position.
- the locking string may also be drawn proximally to increase the clamping force of the device 200 on the septa of the patent foramen ovale. It will be appreciated that the device 200 may still be self-expanding, with the locking string also mechanically actuating the device 200 .
- the device 200 may be made by laser cutting flat stock sheet.
- the device 200 and the eyelets 230 may comprise a metal wire such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- FIG. 2B illustrates an alternative embodiment of a self-expanding closure device including at least one eyelet, and more preferably, a plurality of eyelets 230 to assist with collapse of device 200 into a delivery device.
- the device 200 may have a proximal segment 206 , an intermediate segment 210 , and a distal segment 208 like the embodiment of FIG. 2A , and preferably is formed from a single wire forming three similar shaped segments, which may be generally looped or oval in shape.
- the eyelets 230 are integrally formed by small loops made in the wire, preferably at the proximal end 202 , distal end 204 , and at connecting portions 211 a and 211 b .
- the eyelets 230 are configured to receive an actuator or core 259 , such as hypotubing, solid wire or a guidewire, to releasably secure the device 200 and stress the wire in a longitudinally stretched position during deployment as shown in FIG. 2B .
- an actuator or core 259 such as hypotubing, solid wire or a guidewire
- the core may be retracted proximally, thereby releasing the segments 208 , 210 and 206 . Further details regarding the delivery of this device are described below.
- the segments 206 , 208 , 210 of the device 200 in one embodiment has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in a further embodiment, about 2.5 cm.
- the overall length from the distal end 204 to the proximal end 202 is preferably within the range of about 4 cm to about 20 cm and, in one embodiment, about 8 cm.
- the wire 212 has a diameter of 0.001-0.03 in.
- the device 200 is shown having a paperclip-like shape, it is envisioned that a number of variations of this shape can be utilized to provide the same results.
- a bend may be provided in the device to aid in closure.
- a bend may be placed in the intermediate segment 210 , such that the device 200 is sized and configured to conform to the shape of the patent foramen ovale.
- other non-circular or round shapes may be used for each segment, rather than the annular shape, as discussed above.
- FIG. 5 illustrates the closure device 200 implanted in a patent foramen ovale 120
- the patent foramen ovale 120 includes a septum primum 116 having a surface 126 adjacent the left atrium 104 , and a septum secundum 118 having a surface 124 adjacent the right atrium 114 .
- a tunnel or channel 122 is located between the septum primum 116 and septum secundum 118 .
- the closure device 200 may be delivered to the patent foramen ovale 120 using any suitable technique, such as described below. Once positioned, the distal segment 208 is positioned over the tip 130 of the septum primum 116 and lies along the surface 126 of the septum primum 116 adjacent the left atrium 104 .
- the intermediate segment 210 lies between the septum primum 116 and septum secundum 118 in channel 122 .
- the proximal segment 206 is positioned over the tip 128 of the septum secundum 118 and lies along the surface 124 of the septum secundum 118 adjacent the right atrium 114 .
- the closure device 200 exerts a force on the septum primum 116 and septum secundum 118 to draw the two closer together, either through mechanical actuation or self-expansion of the device.
- the proximal and distal segments are identical in shape, and may have identical shapes that form mirror images of each other across the patent foramen ovale to equally apply compressive force to both sides of the patent foramen ovale.
- the closure device 200 is designed to be implanted using a deployment catheter, such as described with respect to FIGS. 8-12 below.
- the device 200 is designed to remain in a delivery or elongated state while in the catheter (not shown). In this delivery state, the device 200 can assume a generally elongate configuration wherein the proximal end 202 and distal end 204 are pulled apart from each other in a generally linear manner.
- the device 200 is radially expanded ( FIG. 7 ) into a clip or generally S-shaped configuration to occlude or close the patent foramen ovale.
- the device is preferably attached via detachment element 214 to a delivery device such as an actuator prior to deployment, and is then detached at detachment element 214 when properly positioned.
- the detachment element 214 may use a tether line in addition to or instead of a threaded fitting. Tether lines are described in detail in U.S. Pat. Nos. 6,214,029, 6,440,152, and 6,551,344, which are incorporated in their entirety herein. The procedure for placing the closure device and delivery device will be described in further detail hereinafter.
- a closure device deployment system for delivery of a closure device to a patent foramen ovale.
- a closure device deployment system 240 comprises generally a catheter 242 for placing a detachable closure device 200 within a body cavity or lumen.
- the catheter 242 comprises an elongate flexible tubular body 246 , extending between a proximal end 248 and a distal end 250 .
- the catheter is shown in highly schematic form, for the purpose of illustrating the functional aspects thereof.
- the catheter body will have a sufficient length and diameter to permit percutaneous entry into the vascular system, and transluminal advancement through the vascular system to the desired deployment site.
- the catheter 242 will have a length within the range of from about 50 cm to about 150 cm, and a diameter of generally no more than about 15 French. Further dimensions and physical characteristics of catheters for navigation to particular sites within the body are well understood in the art and will not be further described herein.
- the flexible body can be manufactured in accordance with any of a variety of known techniques.
- the flexible body 246 is extruded from any of a variety of materials such as HDPE, PEBAX, nylon, polyimide, and PEEK.
- at least a portion or all of the length of the tubular body may comprise a spring coil, solid walled hypodermic needle or other metal tubing, or braided reinforced wall, as are known in the art.
- the tubular body 246 is further provided with a handle 252 generally on the proximal end 248 of the catheter 242 .
- the handle 252 may be provided with a plurality of access ports.
- handle 252 is provided with an access port which may be used as a guidewire port in an over the wire embodiment, and a deployment wire or actuator port. Additional access ports such as a contrast media introduction port, or others may be provided as needed, depending upon the functional requirements of the catheter.
- the handle 252 permits manipulation of the various aspects of the closure device deployment system 240 , as will be discussed below.
- Handle 252 may be manufactured in any of a variety of ways, typically by injection molding or otherwise forming a handpiece for single-hand operation, using materials and construction techniques well known in the medical device arts.
- An actuator 244 is provided in accordance with one embodiment of the present invention, used to releasably engage and deploy the closure device 200 .
- Any of a variety of structures such as solid cores, polymeric or metal single or multiple strand wires, ribbons, or tubes can be used.
- the actuator 244 may be retracted as with a pullwire design, or rotated as with a torque rod design, as will be discussed herein.
- the actuator 244 may be hollow or solid.
- the deployment catheter is percutaneously introduced into the vascular system and transluminally advanced into the heart and, subsequently, to the patent foramen ovale using techniques which are known in the art.
- the patent foramen ovale may be accessed via catheter through a variety of pathways. It may be accessed from the arterial circuit.
- the catheter is introduced into the arterial vascular system, preferably in the femoral artery, and guided up the descending thoracic and/or abdominal aorta.
- the catheter may then be advanced into the left ventricle through the aortic outflow tract. Once in the left ventricle, the catheter may be directed up through the mitral valve and into the left atrium. When the catheter is in the left atrium, it may be directed into the patent foramen ovale and the closure device deployed.
- the patent foramen ovale may be accessed from the venous circuit.
- the catheter may be introduced into the venous system, preferably in the femoral vein, advanced into the inferior vena cava or superior vena cava and guided into the right atrium.
- the catheter may then be directed to the patent foramen ovale.
- the catheter may be advanced through the tricuspid valve and into the right ventricle and directed to the ventricular septal defect and the closure device deployed.
- a catheter 242 having a single lumen is illustrated.
- an actuator 244 that acts as the actuator for deploying the device 200 .
- the actuator may be an elongate body such as a core wire that extends to the handle 252 , and more preferably may be hollow to provide a passageway for the locking element 228 described with respect to FIG. 2B above.
- the actuator 244 may be removably attached to the proximal end 202 or other point of attachment on the closure device 200 , such as through a threaded attachment at detachment element 214 .
- Proximal retraction of the actuator 244 while resisting proximal motion of the closure device 200 or distally pulling on the closure device will cause elongating of the closure device 200 into its delivery state, as has been discussed.
- the closure device 200 is preferably loaded into the deployment catheter 242 as shown in FIG. 10 .
- the actuator 244 may be locked or removably attached with respect to the closure device 200 , and later severed or otherwise detached to enable removal of the deployment catheter 242 and proximal retraction of the actuator 244 .
- locking of the actuator 244 with respect to the closure device 200 may be accomplished in any of a variety of ways. For example, depending upon the desired catheter design, locking may be accomplished by using interference fit or friction fit structures, tether line, adhesives, a knot, or other technique known to one of ordinary skill in the art.
- the actuator 244 is releasably connected to the proximal end of the closure device 200 . This permits distal advancement of the closure device 200 through the catheter 242 by distal movement of the actuator 244 .
- the proximal end of the actuator 244 may be connected to any of a variety of controls, including rotational knobs, levers and slider switches, depending upon the design preference.
- the actuator is pushed distally until closure device 200 exits the catheter 242 .
- the locking element as described above may be actuated to cause the device to move to its deployed configuration.
- the device 200 may self-expand as it exits the catheter.
- the actuator 244 is released from the device 200 , and the actuator and deployment catheter are removed. Where a locking element is used, this locking element may be cut, released or otherwise secured to fix the position of the closure device. Further details on delivery methods are described below with respect to FIGS. 12A-12E .
- a detachment element 214 may be provided that comprises a threaded attachment located on the distal segment 208 .
- the core wire 259 is inserted through the eyelets 230 of the closure device 200 and is distally threaded to connect with the detachment element, causing elongation of the device 200 into its delivery state.
- the closure device 200 is inserted into the deployment catheter 242 with the core wire inserted through the eyelets 230 of the device 200 and attached at the distal segment 208 .
- the core wire may be advanced out of the deployment catheter to position the closure device in the patent foramen ovale, as discussed below.
- the core wire may then be detached from the distal segment 208 and retracted proximally to deploy the device 200 .
- a hollow push rod positioned proximal to the closure device and over the core wire 259 may be used to assist in releasing the closure device from the core wire.
- the closure device may be positioned distally beyond the distal end of the deployment catheter 242 , and interference between the deployment catheter 242 and the closure device 200 may be used to assist in releasing the closure device from the core wire.
- the detachment element 214 may alternatively comprise a tether line, a threaded fitting, or other technique as is known to one of ordinary skill in the art to releasably secure the closure device 200 to the core wire 259 .
- no detachment element may even be necessary other than the eyelets 230 that secure the closure device 200 to the core wire 259 .
- the device 200 is released to its deployed shape, securing the septa 116 , 118 of the patent foramen ovale, as described further below.
- the actuator 244 or core wire 259 in one embodiment extends axially throughout the length of the catheter body 246 , and is attached at its proximal end to a control on the handle 252 .
- the actuator 244 or core wire 259 may comprise any of a variety of structures which has sufficient lateral flexibility to permit navigation of the vascular system, and sufficient axial column strength to be pushed through the catheter 242 . Any of a variety of structures such as hypotube, solid core wire, “bottomed out” coil spring structures, or combinations thereof may be used, depending upon the desired performance of the finished device.
- the core wire comprises stainless steel tubing.
- core wire is intended to include any of a wide variety of structures which are capable of transmitting axial tension or compression such as a pushing or pulling force with or without rotation from the proximal end 248 to the distal end 250 of the catheter 242 .
- monofilament or multifilament metal or polymeric rods or wires, woven or braided structures may be utilized.
- tubular elements such as a concentric tube positioned within the outer tubular body 246 may also be used as will be apparent to those of skill in the art.
- FIGS. 11A-11D illustrate an alternate construction wherein a closure device is biased toward its deployment configuration, such as being made from a shape memory material, and may be radially enlarged or reduced by rotating a torque element extending through the deployment catheter.
- a rotatable torque rod 260 extends axially through the deployment catheter 242 , and also extends through the closure device 200 , preferably through at least one internally threaded portion provided in the closure device 200 .
- an externally threaded portion 262 of torque rod 260 may engage an internally threaded portion within connecting segment 211 a .
- the rotatable torque rod may be encased in a plurality of tubes (not shown) within the closure device that are positioned approximately diametrically within any or all of segments 206 , 208 , and 210 , said tubes preferably attached to the segments at each end of each tube. These tubes serve to guide the torque rod from the proximal end of the device through the connecting segments to the distal end.
- the proximal end of the torque rod 260 may be connected at a proximal manifold to a manual rotation device such as a hand crank, thumb wheel, rotatable knob or the like.
- the torque rod 260 may be connected to a power driven source of rotational energy such as a motor drive or air turbine.
- torque rod or torque element are intended to include any of a wide variety of structures which are capable of transmitting a rotational torque throughout the length of a catheter body.
- solid core elements such as stainless steel, nitinol or other nickel titanium alloys, or polymeric materials may be utilized.
- the torque rod 260 is preferably provided with an axially extending central guidewire lumen. This may be accomplished by constructing the torque rod 260 from a section of hypodermic needle tubing, having an inside diameter of from about 0.001 inches to about 0.005 inches or more greater than the outside diameter of the intended guidewire.
- Tubular torque rods 260 may also be fabricated or constructed utilizing any of a wide variety of polymeric constructions which include woven or braided reinforcing layers in the wall. Torque transmitting tubes and their methods of construction are well understood in the intracranial access and rotational atherectomy catheter arts, among others, and are not described in greater detail herein.
- One or more distal portions of the torque rod may be threaded as shown in FIGS. 11B and 11D . More particularly, threaded portions 262 may be provided on torque rod 260 , to correspond to internally threaded portions of the distal segment 208 ( FIG. 11D ) or the connecting portions 211 a and 211 b ( FIG. 11B ). A distal threaded portion or distal rotating coupler, not shown, may be provided at the distal end 204 of the device to receive the distal end of the torque rod. As will be appreciated by those of skill in the art in view of the disclosure herein, in one embodiment, rotation of the torque rod 260 in a first direction relative to the closure device 200 will cause the torque rod 260 to advance distally.
- This distal advancement will stress the device and result in an axial elongation and radial reduction of the closure device 200 as the torque rod 260 is advanced distally into the threaded apertures of the closure device 200 .
- Rotation of the torque rod 260 in a reverse direction will cause a proximal retraction of the torque rod 260 , thus enabling a radial enlargement and axial shortening of the closure device 200 .
- the torque rod may be inserted through eyelets 230 formed at the proximal end 202 and connecting segments 211 a and 211 b of the device, thereby axially elongating the device 200 , and threadingly engaging the distal end 204 .
- Disengaging the torque rod 260 from the distal segment 208 will release the segment 208 , permitting the segment 208 to collapse in its deployed position.
- the remaining segments 206 , 210 may be released by proximally retracting the torque rod 260 from the eyelets 230 corresponding to each segment 206 , 210 .
- the torque rod 260 With the torque rod 260 threadingly engaging the device 200 , upon placement of the closure device 200 at the desired implantation site, the torque rod 260 is rotated in a direction that produces an axial proximal retraction. This allows radial enlargement of the radially outwardly biased closure device 200 at the implantation site. Continued rotation of the torque rod 260 will cause the threaded portion to exit proximally through the one or more threaded apertures provided on the closure device 200 .
- the device 200 may be provided beyond the distal end of the deployment catheter 242 , so that when the torque rod is rotated to move the torque rod proximally, the distal force applied by the deployment catheter on the device 200 allows the device to release the torque rod.
- the deployment catheter 242 may also be provided with an antirotation lock (not shown) between a distal end of the catheter 242 and the closure device 200 .
- the rotational lock may be conveniently provided by cooperation between a first surface on the distal end of the deployment catheter 242 , which engages a second surface on the closure device 200 , to rotationally link the deployment catheter 242 and the closure device 200 .
- any of a variety of complementary surface structures may be provided, such as an axial extension on one of the first and second surfaces for coupling with a corresponding recess on the other of the first and second surfaces.
- Such extensions and recesses may be positioned laterally offset from the axis of the catheter.
- they may be provided on the longitudinal axis with any of a variety of axially releasable anti-rotational couplings having at least one flat such as a hexagonal or other multifaceted cross sectional configuration.
- any other means known may be used for temporarily attaching the closure device to a delivery system such as a deployment catheter or actuator.
- a delivery system such as a deployment catheter or actuator.
- any of a variety of interference fit such as threaded fit or snap fit, pin/loop combinations, interfering diameters, or heat dissociable solders or polymer bonds may be utilized.
- the closure device deployment system 240 thus permits the closure device 200 to be maintained in a low crossing profile configuration, to enable transluminal navigation to a deployment site. Following positioning at or about the desired deployment site, distal advancement or proximal retraction of an actuator enables the closure device 200 to radially enlarge. Radial enlargement in one embodiment occurs under the device's own bias. Alternatively, certain embodiments of the closure device can be enlarged under positive force, such as by inflation of a balloon or by a mechanical mechanism as is discussed elsewhere herein. Once the clinician is satisfied with the position of the closure device 200 , such as by injection of dye and visualization using conventional techniques, the actuator is proximally retracted thereby enabling detachment of the closure device 200 from the deployment system 240 .
- the closure device 200 can be radially reduced and axially elongated, thereby enabling repositioning of the closure device 200 at the desired site. In the embodiment of FIG. 10 , this repositioning is allowed by pulling the closure device 200 partially or wholly back into the catheter before release of the detachment element. In the embodiment of FIGS. 11A-D , the torque rod can be distally advanced to reengage the internal threading of the closure device. In some embodiments the torque rod will be guided within tubes attached to the segments (discussed previously). Thus, the closure device 200 can be enlarged or reduced by the clinician to permit repositioning and/or removal of the closure device 200 as may be desired.
- a closure device 200 (shown schematically) is preferably positioned within a patent foramen ovale. Initially, the device 200 is collapsed inside a deployment catheter 242 . The catheter 242 is then positioned at or near the patent foramen ovale 120 , as shown in FIG. 12A , more preferably through the channel 122 between the septum primum and septum secundum. Then, as shown in FIG. 12B , the distal segment 208 of the device is exposed and is pushed out, preferably using an actuator as described above, and deployed over the septum primum 116 .
- the deployment catheter is retracted while releasing the intermediate segment 210 to be positioned inside the patent foramen ovale channel 122 (shown in FIG. 12C ), along a surface of the septum primum and the septum secundum.
- the proximal segment 206 is released from the deployment catheter and positioned against the septum secundum 118 ( FIG. 12D ).
- the positioning of each of the segments relative to the septum primum and septum secundum can occur due to a natural bias of the device as it exits the catheter, due to a mechanical actuation of the distal segment into this position, as described above, or due to a combination of natural bias and mechanical actuation.
- a core may hold each segment 206 , 208 , 210 in a delivery or elongated state until proper positioning may be confirmed. The core may then be retracted, releasing the device 200 for deployment.
- detachment element 214 comprises a flexible segment such as a hinge or braid to allow the device 200 to assume a final implanted attitude without undue distortion applied to the implant or the septa from the deployment catheter.
- the device 200 can also be captured and retrieved at any time during the procedure as long as it is not fully detached from the delivery system. Once in position, the device clips the patent foramen ovale closed by exerting a force on the septum primum and septum secundum to draw the two together.
- the closure device 300 preferably is shaped to form a clip-like device, similar to the closure device of FIG. 2A .
- the closure device has a proximal end 302 and a distal end 304 .
- the closure device generally has three sections: a proximal segment 306 , a distal segment 308 , and an intermediate segment 310 .
- the intermediate segment 310 is preferably a single straight wire preferably covered in a sleeve 324 , rather than an elongated annular wire or loop.
- the intermediate segment 310 may also be cut from flat stock sheet. Both the proximal and distal segments 306 , 308 are generally annular in shape as described above. The segments 306 , 308 , 310 are formed from a wire 312 and are connected by connecting portions 311 a and 311 b , similar to the embodiment discussed above. The segments 306 , 308 , 310 form an integral structure for closing or occluding a patent foramen ovale.
- the closure device 300 is also preferably provided with a detachment element 314 on proximal end, as discussed above.
- the intermediate segment 310 When delivered, the intermediate segment 310 is positioned in the channel between the septum primum 116 and the septum secundum 118 to close the patent foramen ovale 120 , as was described in the embodiment above.
- the distal segment 308 is preferably positioned in the left atrium, while the proximal segment 306 is positioned in the right atrium.
- the closure device 300 is designed to be implanted using a delivery system, such as described above, and may have a collapsed or delivery state, as shown in FIG. 14 .
- the wire 312 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- the intermediate segment 310 is preferably covered with a sleeve 324 .
- the wire of the proximal and distal segments 306 , 308 may also be covered with a sleeve.
- the sleeve 324 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for sleeve 324 can be determined through routine experimentation by those of skill in the art. In one embodiment, the sleeve 324 comprises two layers.
- the two layers may be bonded to each other around the wire 312 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the sleeve 324 in one embodiment preferably is securely attached to the device 300 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- the segments 324 , 310 may be configured to occlude the channel 122 in addition to the closure of the patent foramen ovale induced by the proximal and distal segments 306 , 308 .
- the device 300 includes a locking element 328 and retention elements 330 for retaining the locking element 328 to the closure device 300 , as described above.
- the locking element 328 is used to longitudinally collapse the device and hold it in place at the patent foramen ovale.
- the locking element 328 preferably comprises a locking string which is preferably used to both expand and lock the device at the patent foramen ovale 120 .
- the closure device 300 has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in one embodiment, about 2.5 cm.
- the overall length of the closure device 300 from the distal end 308 to the proximal end 306 is preferably within the range of from about 4 cm to about 20 cm and, in one embodiment, about 8 cm.
- the wire has a diameter of 0.001-0.03 in.
- the device comprises a proximal or an anterior section 402 and a distal or posterior section 404 .
- the anterior section 402 comprises wings 409 , which are used to anchor the device into the correct atrium, preferably the right atrium.
- the wings 409 preferably extend to beyond the edges of the patent foramen ovale to provide additional support to device 400 .
- the anterior and posterior sections 402 , 404 are integral and form a structure which hooks over the tip 130 of the septum primum 116 .
- the device is provided with a loop 410 integral with the structure to attach the device 400 to the delivery device.
- the anterior section 402 , posterior section 404 , and loop 410 are an integral structure and are formed of a single wire 412 .
- the device is preferably shaped like a hook, as can be seen with reference to FIG. 16 , and is preferably self-expanding into the hook shape.
- the anterior section 402 and posterior section 404 are positioned between the septum primum 116 and the septum secundum 118 and hook over the septum primum 116 to close a patent foramen ovale 120 , as shown in FIG. 17 .
- This embodiment stabilizes the flap of the patent foramen ovale 120 .
- the posterior section 404 is positioned in the left atrium, while the anterior section 402 is positioned in the patent foramen ovale and extends out into the right atrium.
- the anterior section 402 is preferably of such a length as to extend along the septum primum 116 to prevent the septum primum 116 from displacing into the left atrium 104 .
- the posterior section 404 prevents the tip 130 of the septum primum 116 from displacing into the left atrium 104 while the anterior section 402 secures the device 400 to the septum primum 116 .
- the anterior section 402 is preferably sized and configured to extend along the right atrium 114 side of the septum primum 116 such that the base of the septum primum 116 provides support to the device 400 , which prevents displacement of the septum primum tip 130 into the left atrium 104 .
- the wire 412 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- a portion of the device 400 is preferably covered with a sleeve 424 as shown in FIG. 16 .
- the sleeve 424 bridges the fossa and patent foramen ovale 120 , while the wire structure stabilizes the flap of the patent foramen ovale 120 .
- the sleeve 424 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for sleeve 424 can be determined through routine experimentation by those of skill in the art. In one embodiment, the sleeve 424 comprises two layers.
- the two layers may be bonded to each other around the wire 412 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the sleeve 424 in one embodiment preferably is securely attached to the device 400 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- a closure device 400 such as described above is preferably positioned within a patent foramen ovale to be closed or occluded.
- the distal end of a deployment catheter 242 is positioned at or near the patent foramen ovale 120 , as shown in FIG. 18A .
- the position may be confirmed using fluoroscopy, echocardiography, or other imaging.
- the device 400 is initially in a collapsed state within catheter 242 , such as described above.
- the left atrium segment 404 of the device 400 is exposed and positioned on the septum primum 116 by advancing or rotating actuator 244 (not shown), as discussed herein. See FIG. 18B .
- actuation of the device 400 may be accomplished as mentioned above.
- actuation of the device 400 may be mechanically induced, self-expanding, a combination of mechanical and self-expanding.
- deployment and detachment of the device may be accomplished as discussed above.
- the device may be deployed via a tether line or torque rod, and detached accordingly as discussed previously.
- a tether line, core wire or other actuator 244 may be attached to loop 410 for releasably deploying the device.
- the device 400 can then be detached from the delivery system, as shown in FIG. 18E .
- the device 400 can also be captured and retrieved at any time during the procedure as long as it is not detached from the actuator 244 .
- the closure device 440 comprises a proximal or an anterior section 442 , a distal or posterior section 444 and an intermediate section 446 .
- the posterior section 444 comprises two legs 449 that extend generally parallel to a longitudinal axis of the device which form an exaggerated “T” shape with the intermediate section 446 .
- the anterior section 442 has a generally rectangular shape. Sections 442 , 444 , and 446 may be self-expanding and form an integral structure 452 , or may be separately joined such as by a hinged connection.
- anchors 447 may be provided to secure the implant against the septum primum 116 and septum secundum 118 .
- the anchors may be punched in the anterior and intermediate section 442 and 446 and heat set or deformed to extend proud of device 440 surface.
- Hole 448 may be provided in proximal end of anterior section 442 to facilitate attachment of a tether and the like to closure device 440 .
- the anterior section 442 is configured and positioned in the right atrium, the posterior section 444 is configured to be positioned in the left atrium, and the intermediate section 446 is configured to be positioned between the septum primum 116 and the septum secundum 118 .
- the posterior section 444 hooks over the septum primum 116 and the anterior section 442 hooks over the septum secundum 118 to occlude or close a patent foramen ovale 120 , as shown in FIG. 20 .
- the septum primum 116 and septum secundum 118 are held together by the clamping force exerted by the clips defined between sections 444 and 446 , and sections 442 and 446 .
- the design minimizes the amount of material exposed to blood flow in the left and right atria, thereby reducing the chance of clot formation.
- the shape is designed to fit the anatomy without distending tissue, thereby reducing the chance of leaks and promoting health.
- the clip structure can be made by laser cutting flat stock sheet.
- the clip structure comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- a closure device 440 is preferably delivered to a defect to be occluded, such as a patent foramen ovale.
- the distal end of the deployment catheter 242 is positioned at or near the patent foramen ovale 120 , as shown in FIG. 21A .
- the position may be confirmed using fluoroscopy, echocardiography, or other imaging.
- the device 440 is initially in a collapsed state within catheter 242 .
- the device 440 may be releasably attached to an actuator 244 , which may be a push rod.
- the distal end of the deployment catheter 242 is advanced between the septum primum 116 and septum secundum 118 as shown in FIG. 21B .
- the posterior portion 444 is advanced out of the distal end of the deployment catheter 242 and over the septum primum 116 , as shown in FIG. 21C , preferably by withdrawing the catheter 242 proximally. As the catheter 242 is withdrawn, the posterior portion 444 flips over into the left atrium 104 and hooks over the septum primum 116 . The intermediate section 446 and anterior sections 442 are then delivered, as shown in FIG. 21D , by further withdrawing the catheter 242 until anterior section 442 flips over the septum secundum 188 . After optimal positioning and sealing is achieved, as shown in FIG. 21D , the device 440 can then be detached from the actuator or tether line 260 and deployment catheter 242 . The device 440 can also be captured and retrieved at any time during the procedure as long as it is not detached from the actuator.
- the device 440 and more particularly the anterior portion 442 , has a length L of about 1 inch, thickness t of about 0.02′′, and a width W of about 0.475′′.
- the length and width of the anterior portion are preferably greater than the length and width of the posterior portion. More preferably, the anterior portion may be approximately twice as long or greater than the posterior portion, and about 25% or more wider than the posterior portion.
- the device 470 is preferably made from a single wire structure, and comprises a proximal or an anterior section 472 , a distal or posterior section 474 , and an intermediate section 476 .
- the posterior section 474 comprises wings 479 which are used to anchor the device into the left atrium.
- the intermediate section 476 may include crossed wire portions as shown in FIG. 22A or non-crossed wire portions as shown in FIG. 22B .
- the anterior section may be hexagonal in shape.
- the anterior, posterior, and intermediate sections 472 , 474 , 476 are integral and form a structure which hooks over the septum primum and the septum secundum.
- the device may be provided with at least one loop 480 at a proximal end of the device integral with the structure.
- a second loop 481 may be provided at the intersection of the anterior and intermediate sections.
- the device 470 may also comprise a third loop 484 at the distal end of the posterior section 474 .
- the function of the first loop 480 , second loop 481 , and third loop 484 will be discussed below with reference to loading and deployment of the device 470 .
- the anterior section 472 , posterior section 474 , intermediate section 476 and at least one loop 480 are preferably an integral structure and are formed of a single wire 482 .
- the device is preferably shaped like a clip, as can be seen with reference to FIG. 23 , when the device is deployed.
- the anterior section 472 is positioned in the right atrium
- the posterior section 474 is positioned in the left atrium
- the intermediate section 476 is positioned between the septum primum 116 and the septum secundum 118 .
- the posterior section 474 hooks over the septum primum 116 and the anterior section 472 hooks over the septum secundum 118 to occlude a patent foramen ovale 120 , as shown in FIG. 23 .
- the wire 482 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- the device may be similarly dimensioned as the embodiment of FIG. 19A .
- the overall width of device 470 may be any value or range of values from about 1 cm to about 5 cm, and, in one embodiment, may be about 2.5 cm.
- the overall length of the closure device 470 may be any value or range of values from about 4 cm to about 20 cm and is, in one embodiment, about 8 cm.
- the diameter of the wire may be any value or range of values from about 0.001-0.030 in, and in one preferred embodiment is about 0.015 in.
- the anterior section 472 may have a covering or be laminated.
- FIGS. 22B and 22C show the device of FIG. 22B with a laminate structure 483 covering the anterior section 472 .
- the lamination may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for the lamination material can be determined through routine experimentation by those of skill in the art. In one embodiment, two layers of lamination are provided.
- the two layers may be bonded to each other around the wire 482 on the anterior section 472 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the lamination material in one embodiment preferably is securely attached to the device 470 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- FIGS. 24A-D there is illustrated a preferred method of loading the device illustrated in FIG. 22B for delivery.
- a mounting shaft 486 is inserted through the second loop 481 of the device 470 such that the anterior section 472 is closer to the proximal end 490 of the mounting shaft 486 and the posterior section 474 is closer to the distal end 488 of the mounting shaft 486 , as shown in FIG. 24A .
- the posterior section 474 and the intermediate section 476 are bent distally such that each wire of the intermediate section 476 is placed along opposite sides of the mounting shaft 486 .
- the portion between the intermediate section 476 and the posterior section 474 rests on the mounting shaft 486 with the third loop 484 extending somewhat radially from the mounting shaft 486 .
- the third loop 484 is then bent over the distal end 488 of the mounting shaft 486 , as shown in FIG. 24C .
- a tether line 492 is looped through the first loop 480 on the proximal end of the device.
- a recapture wire 494 is inserted through the tether line 492 loop.
- the recapture wire 494 preferably does not pass through the first loop 480 of the device, as shown in FIG. 24D .
- the tether line 492 is drawn proximally, the tether line cinches the first loop 480 of the device 470 .
- the tether line 492 is then drawn proximally such that the anterior section 472 is an adjacent to the mounting shaft 486 .
- the mounting shaft 486 may first be inserted through the first loop 480 and fixed with a tether line 492 , followed by the mounting procedure as explained previously.
- the device 470 , tether line 492 , recapture wire 494 , and mounting shaft 486 are then inserted into a sheath (not shown).
- the placement of the closure device 470 is schematically shown in FIG. 23 .
- the sheath is advanced through the channel 122 of the patent foramen ovale, such that the distal end of the sheath extends into the left atrium 104 beyond the tip 130 of the septum primum 116 .
- the mounting shaft 486 is held in place while the sheath is slowly retracted proximally until the posterior section 474 is released from the sheath.
- the wings 479 of the posterior section 474 may be extended out by slightly advancing the sheath distally while holding the mounting shaft 486 in place.
- the mounting shaft 486 and the sheath are then retracted proximally until the wings 479 of the posterior section 474 engage the septum primum 116 .
- the mounting shaft 486 is held in place while the sheath is retracted proximally allowing the wings 479 to secure the septum primum.
- the sheath is then retracted further until the entire device 470 is exposed.
- the tether line 492 and recapture wire 494 are advanced distally, allowing the anterior section 472 to advance and oppose the right atrium side of the septum secundum. With the tether line 492 and recapture wire 494 still secured to the first loop 480 , the entire device 470 may be recaptured if required.
- the tether line 492 and recapture wire 494 may also assist in repositioning the anterior section 472 of the device. Optimal positioning of the device may be confirmed using fluoroscopy, echocardiography, or other imaging. Once optimal positioning is confirmed, the mounting shaft is retracted proximally, and the recapture wire 494 is withdrawn proximally to release the tether line 492 loop. The mounting shaft 486 , tether line 492 , recapture wire 494 , and sheath are then removed.
- FIGS. 25-32 there is illustrated another preferred embodiment of the present invention.
- the device is shown in an unexpanded state in FIGS. 25 and 26 .
- a closure device 500 is provided having a soft distal tip 502 , connected to a distal hub 504 , and a soft proximal tip 506 , connected to a proximal hub 508 .
- the device also comprises at least two sealing arms 510 .
- the sealing arms 510 are preferably heat-set. When the device is expanded, the arms 510 have a generally round shape, as shown in FIG. 27 .
- the device 500 also comprises at least two anchors 512 , 513 integrally formed with the distal and proximal hubs 504 , 508 and the sealing arms 510 .
- the anchors deflect outwards upon expansion to retain the septum primum 116 and septum secundum 118 , as will be described.
- the device 500 is preferably made from a laser-cut hypotube.
- the distal hub 504 and proximal hub 508 are drawn together, thereby compressing the device 500 and expanding the sealing arms 510 for positioning in a patent foramen ovale 120 channel 122 .
- the closure device 500 is provided with one or more retention structures for retaining the device in the patent foramen ovale or other similar septal defects. See FIG. 26 .
- a plurality of barbs or other anchoring elements 522 are provided, for engaging adjacent tissue to retain the closure device 500 in its implanted position and to limit relative movement between the tissue and the closure device.
- the illustrated barbs 522 are provided on the anchors 512 , 513 . The barbs resist migration of the closure device away from the patent foramen ovale.
- the arms 510 are preferably positioned in the channel 122 between the septum primum 116 and the septum secundum 118 to close the patent foramen ovale 120 , as shown in FIG. 28 .
- a first anchor 513 is positioned in the left atrium, while a second anchor 512 is positioned in the right atrium. The anchors 512 , 513 deflect outwardly to secure the septum primum 116 and septum secundum 118 , to close the patent foramen ovale 120 .
- the device 500 is formed of a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the material may also be biodegradable. Material having a circular, rectangular, or other cross-section may be utilized depending upon the manufacturing technique.
- material with a circular cross section is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- the device may also comprise a sleeve over at least a portion of the device.
- the sleeve may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for sleeve can be determined through routine experimentation by those of skill in the art.
- the sleeve comprises two layers. The two layers may be bonded to each other around the device in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the sleeve in one embodiment preferably is securely attached to the device 500 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- the device 500 is further provided with an expansion and detachment element 514 at its distal end.
- the expansion and detachment element 514 may be either a pull wire design ( FIGS. 29-30 ), a turn screw design ( FIGS. 31-32 ), a tether line, or other method known by one of ordinary skill in the art that may be used to collapse and lock the closure device in its expanded state.
- the device is preferably attached via detachment element 514 to a delivery system as described above prior to deployment, and is then detached at detachment element 514 when properly positioned. The device can then be detached from the delivery system at the same place.
- deployment and detachment of the device may be accomplished by torque rods, as discussed previously with reference to FIGS. 11A-B .
- deployment and detachment may be accomplished by tether lines as previously discussed. Other methods that are known by one of ordinary skill in the art may also be used.
- the closure device 600 comprises an occluding member 602 comprising a frame 604 and a barrier 606 .
- the frame 604 comprises a plurality of radially outwardly extending spokes 608 each having a length within the range of from about 1 cm to 6 cm.
- the device has a proximal end 610 and a distal end 612 corresponding to a proximal hub 614 and a distal hub 616 .
- a central hub 618 is also preferably provided between the proximal hub 614 and distal hub 616 .
- the frame 604 and barrier 606 form a proximal segment 620 and a distal segment 622 .
- the designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter.
- Proximal and distal segments 620 , 622 are baskets which secure the septum primum 116 and septum secundum 118 on both sides, thus sealing the patent foramen ovale.
- the spokes 608 are advanceable from a generally axially extending orientation such as from within a tubular introduction catheter to a radially inclined orientation.
- the spokes are biased radially outwardly such that the closure member expands to its enlarged, implantation cross-section under its own bias following deployment from the catheter.
- the closure member may be enlarged using any of a variety of enlargement structures such as an inflatable balloon, or a catheter for axially shortening the closure member, as is discussed further below.
- expansion of the device may be accomplished by torque rods, as discussed previously with reference to FIGS. 11A-B .
- the proximal hub 614 may threadingly engage the torque rod such that rotation of the torque rod will expand or contract the device 600 .
- the distal hub 616 may operate to support the distal end of the torque rod, permitting the torque rod to rotate freely upon its axis with the distal hub 616 .
- the distal hub 616 may also be threadingly engaged to the torque rod.
- the device 600 is preferably advanced through the channel 122 of the patent foramen ovale 120 until the distal end of the catheter is beyond the tip 130 of the septum primum 116 .
- the device 600 is preferably advanced until the distal end 616 of the device 600 extends into the left atrium 104 .
- the distal segment 622 is exposed from the catheter, such that it expands to its enlarged, implantation cross-section and engages the septum primum 116 wall on the left atrium 104 side.
- the device 600 then is then drawn proximally to draw the septum primum 116 toward the septum secundum 118 , closing the channel 122 .
- the proximal segment 620 of the device 600 is then exposed and permitted to expand to its enlarged, implantation cross-section, securing the septum secundum 118 to the septum primum 116 .
- spokes may be utilized anywhere within the range of from about 3 spokes to about 40 spokes. In some embodiments, anywhere from about 12 to about 24 spokes are utilized, and 18 spokes are utilized in one embodiment.
- the spokes comprise a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique.
- rectangular cross section spokes are cut such as by known laser cutting techniques from tube stock, a portion of which forms the hubs 614 , 616 , 618 .
- the barrier 606 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for barrier 606 can be determined through routine experimentation by those of skill in the art.
- the barrier 606 may be provided on either one or preferably both axially facing sides of the closure member.
- the barrier 606 comprises two layers, with one layer on each side of the frame 604 .
- the two layers may be bonded to each other around the spokes 608 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the barrier 606 preferably has a thickness of no more than about 0.003 in.
- the occluding member 600 has an expanded diameter within the range of from about 10 mm to about 40 mm, and, in one embodiment, about 20 mm.
- the overall length of the closure device 600 from the distal end 612 to the distal end 610 is within the range of from about 40 mm to about 100 mm and, in one embodiment, about 70 mm.
- the closure device 650 comprises a closure member 652 comprising a frame 654 and a barrier 656 .
- the frame 654 comprises a plurality of radially outwardly extending spokes 658 .
- the device has a proximal end 660 and a distal end 662 , corresponding to a proximal hub 664 and a distal hub 666 .
- a central hub 668 is also preferably provided between the proximal hub 664 and distal hub 666 .
- the frame 654 and barrier 656 form a proximal segment 670 and a distal segment 672 .
- Proximal and distal segments 670 , 672 are concave faced baskets, which secure the septum primum and septum secundum on both sides, thus sealing the patent foramen ovale.
- Deployment of the device 650 preferably corresponds to the deployment discussed above with reference to FIGS. 33-34 .
- the closure device 700 comprises a closure member 702 comprising a frame 704 and a barrier 706 .
- the frame 704 comprises a plurality of radially outwardly extending supports (not shown).
- the device has a proximal end 710 and a distal end 712 corresponding to a proximal hub 714 and a distal hub 716 .
- a soft distal tip 718 is also preferably provided at the distal end 712 , and is connected to distal hub 716 .
- the frame 704 and barrier 706 form a proximal segment 720 and a distal segment 722 .
- proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter.
- Proximal and distal segments 720 , 722 behave like baskets to secure the septum primum and septum secundum on both sides, thus sealing the patent foramen ovale.
- the device is shown in an unexpanded state.
- Proximal retraction on the deployment line 730 while resisting proximal movement of proximal hub 714 such as by using the distal end of the catheter 732 will cause the distal hub 716 to be drawn towards the proximal hub 714 , thereby radially enlarging the cross-sectional area of the closure device 700 , as shown in FIG. 38B .
- the supports 708 will retain the radially enlarged orientation by elastic deformation, or may be retained in the enlarged orientation such as by securing a slip knot immovably to the deployment line 730 at the fully radially enlarged orientation.
- the closure device 750 comprises an occluding member 752 comprising a frame 754 and a barrier 756 .
- the frame 754 comprises a plurality of radially outwardly extending spokes 758 .
- the device has a proximal end 760 a distal end 762 corresponding to a proximal hub 764 and a distal hub 766 .
- a central hub 768 is also preferably provided between the proximal hub 764 and distal hub 766 .
- a soft distal tip 769 is also preferably provided at the distal end 762 , and is connected to distal hub 766 .
- the frame 754 and barrier 756 form a proximal segment 770 and a distal segment 772 .
- the designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter.
- Proximal and distal segments 770 , 772 are umbrellas which secure the septum primum and septum secundum on both sides, sealing the patent foramen ovale.
- the proximal and distal segments 770 , 772 have a generally concave inwardly facing surface 774 and convex outwardly facing surface 776 .
- the device is shown in a collapsed state in FIG. 41 . Deployment of the device 750 preferably corresponds to the deployment discussed above with reference to FIGS. 33-34 .
- the closure device 800 comprises a frame 804 and a barrier 806 .
- the frame 804 comprises a plurality of radially outwardly extending spokes 808 .
- the device has a proximal end 810 a distal end 812 corresponding to a proximal hub 814 and a distal hub 816 .
- the frame 804 and barrier 806 form a proximal segment 820 and a distal segment 822 .
- the designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter.
- Proximal and distal segments 820 , 822 are umbrellas which secure the septum primum and septum secundum on both sides, thus sealing the patent foramen ovale.
- the proximal and distal segments 820 , 822 have a generally flat inwardly facing surface 824 and an angled outwardly facing surface 826 .
- the device 800 is shown in a collapsed position in FIG. 45 . Deployment of the device 800 preferably corresponds to the deployment discussed above with reference to FIGS. 33-34 .
- a closure device 1400 is preferably positioned within a septal defect to be occluded, such as a patent foramen ovale or an atrial septal defect.
- a septal defect to be occluded such as a patent foramen ovale or an atrial septal defect.
- the distal end 1402 of the delivery catheter 1404 is positioned at or near the patent foramen ovale 120 .
- the position may be confirmed using fluoroscopy, echocardiography, or other imaging.
- the device 1400 is initially in a collapsed state in catheter 1404 .
- the actuator 1408 shown in FIG. 44C
- the actuator 1408 is thereafter proximally retracted or rotated, as with a torque rod, to place and expand the closure device 1400 at the patent foramen ovale 120 .
- proximal retraction or rotation on the actuator 1408 while resisting proximal movement of proximal hub 1410 such as by using the distal end of the catheter 1404 will cause the distal hub 1412 to be drawn towards the proximal hub 1410 .
- the closure device 1400 engages the septa walls thereby closing the patent foramen ovale.
- the actuator may then be locked with respect to the proximal hub and severed or otherwise detached to enable removal of the deployment catheter and proximal extension of the actuator.
- Locking of the actuator 1408 with respect to the closure device 1400 may be accomplished in a variety of ways, such as by using interference fit or friction fit structures, adhesives, a knot or other techniques depending upon the desired catheter design, as discussed herein.
- the catheter 1402 is detached from the device 1400 and removed from the patient. See FIG. 44 .
- the device 1400 can also be captured and retrieved at any time during the procedure as long as it is not detached from the delivery catheter.
- the closure device 850 comprises a proximal inflatable balloon 852 and a distal inflatable balloon 854 joined together at a central hub 856 .
- the device 850 may also comprise a frame, comprising a plurality of supports.
- the device 850 is preferably expanded by inflating the balloons 852 , 854 via an inflation catheter by inserting inflation fluid through inflation lumen 858 .
- the central hub 856 is positioned within the patent foramen ovale, while the proximal balloon 852 is preferably positioned in the right atrium and the distal balloon 854 is positioned in the left atrium, to occlude the patent foramen ovale.
- the patent foramen ovale is simply held together by positioning a device 900 , 950 to hold the septum primum 116 and septum secundum 118 together.
- the device 900 comprises a proximal end 906 and a distal end 908 , having a proximal anchor 910 and a distal anchor 912 .
- a device 950 comprises a proximal end 956 and a distal end 958 .
- the device has a screw-like configuration and comprises a coiled wire or threaded screw 960 .
- the proximal end 906 , 956 is preferably positioned in the right atrium, while the distal end 908 , 958 is positioned in the left atrium.
- the device 900 , 950 includes a detachment zone 914 , 964 .
- the device may also be provided with a sleeve, as has been discussed with previous embodiments.
- the device 900 , 950 is formed of a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- a closure device 1000 comprising a closure member is shown.
- the device comprises a proximal end 1002 and a distal end 1004 , and a circular proximal section 1006 and circular distal section 1008 , which are connected via a center strut 1010 , forming an integral structure.
- the center strut 1010 preferably contains a closure or thrombotic material 1011 .
- a loop 1012 is provided for holding and retrieving the device 1000 .
- the proximal and distal sections 1006 , 1008 act like springs, and maintain stability and help to squeeze the patent foramen ovale.
- the center strut 1010 rests within the patent foramen ovale 120 for occluding the channel 122 , engaging the septum primum 116 and the septum secundum 118 .
- the proximal section 1006 is preferably positioned in the right atrium, while the distal section 1008 is positioned in the left atrium.
- the device 1000 is formed of a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- the wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock.
- the closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock.
- the thrombotic material 1011 may include DACRONTM, or others which can be determined through routine experimentation by those of skill in the art.
- a closure device 1050 comprising a porous sponge or sponge-like material is shown.
- the closure device 1050 may comprise a fluid-filled bag with a porous or semi-porous other covering.
- the closure device 1050 has a generally cylindrical shape.
- the sponge is at least as large as the defect to be filled.
- tether 1055 extends through closure device 1050 and is used to attach closure device 1050 to delivery catheter 1504 .
- FIG. 53 illustrates the sponge-like closure device 1050 positioned at a patent foramen ovale. The sponge expands upon placement to close the defect and is secured in place by the septum primum 116 and septum secundum 118 .
- the sponge or sponge-like material may comprise collagen, PE, PTFE, Poly Vinyl Acetate (Ivalon), or Ethyl Vinyl Acetate.
- the material may be bioresorbable.
- the sponge promotes tissue ingrowth for more complete sealing of a septal defect, such as a patent foramen ovale.
- the anchor device 1060 comprises a frame 1062 having a plurality of retention elements 1064 provided thereon.
- the frame may be perforated, while in other embodiments, the frame is solid.
- the anchor device 1060 may be comprised of a plurality of laser cut strips 1065 , as shown in FIG. 55 .
- the laser cut strips comprise a laser-cut body 1066 which can be twisted to reveal anchors 1068 .
- a detailed view of the body 1066 and anchors 1068 is shown in FIG. 56 .
- the anchor device 1060 may be used with the sponge-like closure device 1050 to form an anchored sponge closure device 1070 .
- the anchors may be used to further secure the sponge-like closure device in place.
- FIG. 58 illustrates closure device 1070 , wherein anchor devices 1060 secure the sponge-like closure device 1050 at a defect.
- a preferably method is shown of deploying the closure device 1500 within a septal defect, such as a patent foramen ovale.
- a septal defect such as a patent foramen ovale.
- the distal end 1502 of the delivery catheter 1504 is positioned at or near the patent foramen ovale 120 , as shown in FIG. 59A .
- the position may be confirmed using fluoroscopy, echocardiography, or other imaging.
- the device 1500 is initially in a collapsed state within catheter 1504 .
- the device 1500 may be releasably attached to an actuator 1508 .
- the distal end 1502 of the delivery catheter 1504 is advanced between the septum primum 116 and septum secundum 118 as shown, and the posterior portion 1510 is advanced out of the distal end 1502 of the delivery catheter 1504 , as shown in FIG. 59B .
- the intermediate section and posterior sections are then delivered, as shown in FIG. 59C .
- the device 1500 can then be detached from the delivery catheter 1504 .
- any of the closure devices disclosed herein may also be coated with a therapeutic substance, such as an anti-thrombogenic drug.
- the therapeutic substances are typically either impregnated into the device or carried in a polymer that coats the device. The therapeutic substances are released from the device or polymer once it has been implanted in the vessel.
- the device may be impregnated with at least one drug or coated with at least one drug by any known process in the art.
- the drug may be carried in a volatile or non-volatile solution.
- drug denotes any compound which has a desired pharmacological effect, or which is used for diagnostic purposes.
- closure devices as disclosed herein are preferably asymmetrical.
- the axis of a patent foramen ovale tends to be at an angle, and almost parallel to the septal wall. Accordingly, asymmetrical closure devices will be effective in closing septal defects having non-longitudinal axes, such as a patent foramen ovale.
- a radiopaque dye or other visualizable media may be introduced on one side or the other of the closure device, to permit visualization of any escaped blood or other fluid past the closure device.
- the closure device may be provided with a central lumen or other capillary tube or aperture which permits introduction of a visualizable dye from the deployment catheter through the closure device and into the space on the distal side of the closure device.
Abstract
A patent foramen ovale closure device, method of delivering and a delivery system are provided. The device may include a closure device releasably connectable to an actuator. The device may include a proximal segment, an intermediate segment and a distal segment. When delivered, the proximal segment and intermediate segment form a first clip-shaped portion sized and configured to be positioned over a septum secundum of the patent foramen ovale, and the intermediate segment and distal segment form a second clip-shaped portion sized and configured to be positioned over a septum primum of the patent foramen ovale.
Description
- This application is a Continuation of co-pending U.S. patent application Ser. No. 10/771,845, filed on Feb. 4, 2004, which claims the benefit of U.S. Provisional Application No. 60/445,088, filed Feb. 4, 2003, the entirety of which is hereby incorporated by reference.
- 1. Field of the Invention
- Embodiments of the present invention relate to methods and devices for closing a body lumen or cavity and, in particular, for closing a patent foramen ovale.
- 2. Description of the Related Art
- Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability. There are over 700,000 strokes per year in the United States alone. Of these, roughly 100,000 are hemorrhagic, and 600,000 are ischemic (either due to vessel narrowing or to embolism). About 50,000 of the ischemic strokes are believed to be caused by a patent foramen ovale. However, the risk of recurrent stroke is higher in patients whose strokes are caused by a patent foramen ovale.
- Pharmacological therapies for stroke prevention such as oral or systemic administration of warfarin or the like have been inadequate due to serious side effects of the medications and lack of patient compliance in taking the medication.
- In general, the heart is divided into four chambers, the two upper being the left and right atria and the two lower being the left and right ventricles. The atria are separated from each other by a muscular wall, the interatrial septum, and the ventricles by the interventricular septum.
- Either congenitally or by acquisition, abnormal openings, holes or shunts can occur between the chambers of the heart or the great vessels (interatrial and interventricular septal defects or patent ductus arteriosus and aortico-pulmonary window respectively), causing shunting of blood through the opening. A patent foramen ovale is a condition wherein an abnormal opening is present in the septal wall between the two atria of the heart. Blood can flow directly between these two atria, compromising the normal flow of blood and efficiency of the patient's heart. The deformity is usually congenital, resulting from a failure of completion of the formation of the septum, or wall, between the two sides during fetal life when the heart forms from a folded tube into a four-chambered, two unit system.
- In contrast to other septal defects which tend to have a generally longitudinal axis, a patent foramen ovale tends to behave like a flap valve. Accordingly, the axis of the patent foramen ovale tends to be at an angle, and almost parallel to the septal wall.
- These deformities can carry significant sequelae. For example, with a patent foramen ovale, blood is shunted from the left atrium of the heart to the right, producing an over-load of the right heart. In addition to left-to-right shunts such as also occur in patent foramen ovale, the left side of the heart has to work harder because some of the blood which it pumps will recirculate through the lungs instead of going out to the rest of the body. The ill effects of these defects usually cause added strain on the heart with ultimate failure if not corrected.
- Previously, patent foramen ovale have required relatively extensive surgical techniques for correction. To date the most common method for closing intracardiac shunts, such as a patent foramen ovale, entails the relatively drastic technique of open-heart surgery, requiring opening the chest or sternum and diverting the blood from the heart with the use of a cardiopulmonary bypass. The heart is then opened, the defect is sewn shut by direct suturing with or without a patch of synthetic material (usually of Dacron, Teflon, silk, nylon or pericardium), and then the heart is closed. The patient is then taken off the cardiopulmonary bypass machine, and the chest is closed.
- In place of direct suturing, closures of a patent foramen ovale by means of a mechanical prosthesis have also been disclosed. A number of these devices, designed for closures of interauricular septal defects, have been used to correct patent foramen ovale.
- Although these devices have been known to effectively close other septal defects, there are few closure devices which have been developed specifically for closing patent foramen ovale. Although these devices have been effective in some cases, there is still much room for improvement.
- Notwithstanding the foregoing, there remains a need for a method and improved apparatus for correcting patent foramen ovale.
- Embodiments of the present invention provide a minimally invasive closure device for closing a patent foramen ovale. Improved delivery and positioning systems are also provided.
- In accordance with one embodiment, a closure device for closing a patent foramen ovale is provided. The device includes a proximal end, a distal end, a proximal segment, an intermediate segment, and a distal segment, wherein each of the segments is sequentially aligned. The device has a generally elongate configuration and a clip configuration. When the device is in its elongate configuration, the proximal and distal ends are pulled away from each other such that the proximal segment, intermediate segment, and distal segment become relatively more linear. When the device is in its clip configuration, the proximal segment and intermediate segment are drawn into a first clip-shaped portion sized and configured to be positioned over a septum secundum of the patent foramen ovale. The intermediate segment and distal segment are drawn into a second clip-shaped portion sized and configured to be positioned over a septum primum of the patent foramen ovale. The first clip-shaped portion and the second clip-shaped portion provide a force against the septum primum and septum secundum to pinch the two relatively closer together.
- In one embodiment, the closure device may be formed from a wire structure, more preferably one integral wire. In one embodiment, the proximal and distal segments are identical in shape, and may have identical shapes that form mirror images of each other across the patent foramen ovale to equally apply compressive force to both sides of the patent foramen ovale. In another embodiment, the proximal segment has a larger dimension than the distal segment, and more preferably has both a greater length and width than the distal segment. The distal segment may include a pair of wings adapted to extend over the tip of the septum primum. The device may also include loops, eyelets or other structure adapted for releasable engagement with a delivery system, as described below. The device may also include anchors or other tissue engaging structures to facilitate securement of the device in the patent foramen ovale.
- In accordance with another embodiment, a closure device for closing a patent foramen ovale is provided. The device includes a proximal segment, a distal segment, and an intermediate segment which may be integrally formed, preferably from an integral wire structure. A covering, sleeve or laminate structure is provided on at least one of the segments of the device. In one embodiment, a sleeve is provided over the intermediate segment and is adapted to be positioned in the tunnel of the patent foramen ovale. In another embodiment a laminate structure may be provided over at least the proximal or anterior portion. The sleeve may be made of a material that facilitates cellular in-growth, such as ePTFE.
- In accordance with one embodiment, a method of closing a patent foramen ovale having a septum primum and a septum secundum is provided. The method includes providing a closure device having a proximal end and a distal end and having a generally elongate configuration and a clip configuration. When the device is in its elongate configuration, the proximal and distal ends are pulled away from each other, and when the device is in its clip configuration the device has generally an S-shape. The device is releasably attached relative to a delivery device. The device is then delivered to the patent foramen ovale with the delivery device, the closure device being held relative to the delivery device in its elongate configuration. The closure device is deployed in the patent foramen ovale, such that the device when deployed includes a first clip-shaped portion positioned around the septum secundum and a second clip-shaped portion positioned around the septum primum.
- In accordance with a further embodiment, a method of closing a patent foramen ovale having a septum primum and a septum secundum in provided. The method includes providing a closure device having a proximal end, a distal end, a proximal segment, an intermediate segment and a distal segment. The method further includes deploying the closure device within the patent foramen ovale such that the distal segment lies along a surface of the septum primum within the left atrium of the patient. The proximal segment preferably lies along a surface of the septum secundum within the right atrium of the patient. The intermediate segment preferably lies in a channel or tunnel between the septum primum and the septum secundum. When the closure device is deployed, it exerts a force between the proximal segment and intermediate segment and between the intermediate segment and distal segment to draw or pinch the septum primum and septum secundum together.
- In accordance with another embodiment, a method of closing a patent foramen ovale is provided. The method includes positioning a closure device at a patent foramen ovale and deploying the closure device, such that the septum primum and septum secundum are secured together by the closure device.
- In a preferred delivery method, the closure device is self-expanding and may be releasably engaged with a percutaneous delivery device. In one embodiment, where the closure device has proximal, intermediate and distal segments, each of the segments is releasably engaged with the delivery device, such as by extending a core or guidewire through eyelets formed in each of the segments of the device. In another embodiment, the closure device may be internally or externally threaded to releasably engage a corresponding delivery device. This threading may be provided at the proximal end of the device, at the distal end of the device, or may be provided in proximal, intermediate and/or distal segments. The closure device may be delivered through an outer deployment catheter which guides the device to the patent foramen ovale.
- In accordance with one embodiment, a closure device for closing a patent foramen ovale is provided. The device includes a proximal segment and a distal segment which may be integrally formed. The device generally has a hook configuration, wherein the distal segment is sized and configured to be positioned over a septum primum of the patent foramen ovale. The proximal segment is sized and configured to extend through the tunnel of the patent foramen ovale, and at its proximal end, may increase in width to form wings to secure the closure device in place. In this configuration, the proximal segment is sized and configured to be positioned along a surface of the septum of the patent foramen ovale in the right atrium. The device may also include a sleeve or laminate structure between the proximal end and the distal segment, the sleeve or laminate structure adapted to be positioned in the patent foramen ovale tunnel. The sleeve or laminate structure is made of material adapted to facilitate cellular in-growth, such as ePTFE.
- In accordance with a further embodiment, a method of closing a patent foramen ovale is provided. The method includes positioning a closure device at a patent foramen ovale and deploying the closure device, such that the septum primum is secured by the closure device. In one embodiment, only the septum primum is secured by the closure device, with the device forming a hook over the tip of the septum primum to hold the septum primum in place. Preferably, the closure device may have wings in a proximal segment thereof that extend beyond the width of the tunnel of the patent foramen ovale. The wings as delivered are positioned in the right atrium against a surface of the septum primum.
- In another embodiment, delivery systems incorporating the devices used in the delivery methods are provided. According to one delivery system, a deployment catheter having a proximal end and a distal end is provided. An actuator extends through the deployment catheter. A closure device is releasably attached to the actuator. The actuator is adapted to advance the closure device from the distal end of the deployment catheter and position a distal segment of the closure device over a septum primum of the patent foramen ovale and position a proximal segment of the closure device over a septum secundum of the patent foramen ovale. The closure device is actuatable to pinch together the septum primum and septum secundum once delivered, and may be self-expanding and/or manually actuated. It will also be appreciated that the closure device can be delivered without the deployment catheter, such that the closure device is releasably secured and released from the actuator to deliver the device.
-
FIG. 1 is an anterior illustration of a heart, with the proximal parts of the great vessels. -
FIG. 2A is a perspective view of a closure device in accordance with one embodiment the present invention. -
FIG. 2B is a perspective view of a closure device in accordance with one embodiment of the present invention in a delivery state. -
FIG. 3 is a side elevational view of the closure device shown inFIG. 2A . -
FIG. 4 is a cross-sectional view of one of the segments of the closure device shown inFIG. 2A . -
FIG. 4A is an enlarged view of a portion of the segment ofFIG. 4 . -
FIG. 5 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 2A , shown schematically. -
FIG. 6 is a perspective view of the closure device ofFIG. 2A in a delivery state. -
FIG. 7 is a perspective view of the closure device ofFIG. 2A during a deployment state. -
FIG. 8 is a schematic cross-sectional view through the heart with a transeptal catheter deployed at a patent foramen ovale. -
FIG. 9 is a cross-sectional view of the catheter ofFIG. 8 through line 9-9. -
FIG. 10 is a partial cross-sectional view of an embodiment of the catheter ofFIG. 8 , with a closure device being delivered there through. -
FIG. 11A is a partial cross-sectional view of an embodiment of the catheter ofFIG. 8 , with an embodiment of a closure device illustrated being delivered using a torque rod. -
FIG. 11B is an enlarged view of a connecting portion of the closure device shown inFIG. 11A . -
FIG. 11C is a partial cross-sectional view of another embodiment of the catheter ofFIG. 8 , with another embodiment of a closure device being delivered there through. -
FIG. 11D is an enlarged view of a distal portion of the closure device shown inFIG. 11C . -
FIGS. 12A-E are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention. -
FIG. 13 is a perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 14 is a perspective view of the closure device ofFIG. 13 in a delivery state. -
FIG. 15 is a back elevational view of a closure device in accordance with another embodiment of the present invention. -
FIG. 16 is a side view of the closure device ofFIG. 15 . -
FIG. 17 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 15 . -
FIGS. 18A-E are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention. -
FIG. 19A is a front elevational view of a closure device in accordance with another embodiment of the present invention. -
FIG. 19B is a side elevational view of the closure device shown inFIG. 19A . -
FIG. 20 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 19 . -
FIGS. 21A-D are schematic views of a patent foramen ovale closure procedure in accordance with another embodiment of the present invention. -
FIG. 22A is a back view of a closure device in accordance with another embodiment of the present invention. -
FIG. 22B is a back view of a closure device in accordance with another embodiment of the present invention. -
FIG. 22C is a front view of the device ofFIG. 22B , showing a laminated structure attached thereto. -
FIG. 23 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 22A orFIG. 22B , shown schematically. -
FIGS. 24A-D are schematic views of a patent foramen ovale closure procedure in accordance with one embodiment of the present invention, shown inversely to the deployment orientation to facilitate explanation. -
FIG. 25 is a side elevational view of a closure device in accordance with another embodiment of the present invention. -
FIG. 26 is a side elevational view of the closure device ofFIG. 25 having a plurality of retention structures. -
FIG. 27 is a rear elevational view of the closure device ofFIG. 25 . -
FIG. 28 is a partial cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 25 . -
FIG. 29 is a front elevational view of the closure device ofFIG. 25 prior to expansion having a pull wire expansion system. -
FIG. 30 is a front elevational view of the closure device ofFIG. 25 after expansion having a pull wire expansion system. -
FIG. 31 is a front elevational view of the closure device ofFIG. 25 prior to expansion having a twisting expansion system. -
FIG. 32 is a front elevational view of the closure device ofFIG. 25 after expansion having a twisting expansion system. -
FIG. 33 is a schematic side view of a closure device in accordance with another embodiment of the present invention. -
FIG. 34 is an end view of the closure device ofFIG. 33 . -
FIG. 35 is a side view of a closure device in accordance with another embodiment of the present invention. -
FIG. 36 is an end view of the closure device ofFIG. 35 . -
FIG. 37 is a side view of a closure device in accordance with another embodiment of the present invention. -
FIGS. 38A-B are side schematic views showing the expansion of the closure device ofFIG. 37 . -
FIG. 39 is a side view of a closure device in accordance with another embodiment of the present invention. -
FIG. 40 is an end view of the closure device ofFIG. 39 . -
FIG. 41 is a side view of the closure device ofFIG. 39 in a collapsed state. -
FIG. 42 is a side view of a closure device in accordance with another embodiment of the present invention. -
FIG. 43 is an end view of the closure device ofFIG. 42 . -
FIGS. 44A-C are schematic views of a defect closure procedure in accordance with one embodiment of the present invention. -
FIG. 45 is a side view of the closure device ofFIG. 42 in a collapsed state. -
FIG. 46 is a perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 47 is a cross-sectional view of a patent foramen ovale closed with a closure device in accordance with another embodiment of the present invention. -
FIG. 48 is a cross-sectional view of a patent foramen ovale closed with a closure device in accordance with another embodiment of the present invention. -
FIG. 49 is a side elevational view of a closure device in accordance with another embodiment of the present invention. -
FIG. 50 is a front view of the closure device ofFIG. 49 . -
FIG. 51 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 40 . -
FIG. 52 is a perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 53 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 52 . -
FIG. 54 is a perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 55 is an enlarged perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 56 is a side view of the closure device ofFIG. 55 . -
FIG. 57 is a perspective view of a closure device in accordance with another embodiment of the present invention. -
FIG. 58 is a cross-sectional view of a patent foramen ovale closed with the closure device ofFIG. 57 . -
FIGS. 59A-C are schematic views of a defect closure procedure in accordance with one embodiment of the present invention. - For simplicity, preferred embodiments of the present invention will be described primarily in the context of a patent foramen ovale closure procedure. However, the devices and methods herein are readily applicable to a wider variety of closure or attachment procedures, and all such applications are contemplated by the present inventors. For example, additional heart muscle procedures such as atrial septal defect closure and patent ductus arteriosis closure are contemplated. Vascular procedures such as isolation or repair of aneurysms, anastomosis of vessel to vessel or vessel to prosthetic tubular graft joints may also be accomplished using the devices of the embodiments described herein. Attachment of implantable prostheses, such as attachment of the annulus of a prosthetic tissue or mechanical heart valve may be accomplished. A variety of other tissue openings, lumens, hollow organs and surgically created passageways may be closed. Adaptation of the devices and methods disclosed herein to accomplish procedures such as the foregoing will be apparent to those of skill in the art in view of the disclosure herein.
- Referring to
FIG. 1 , aheart 100 is illustrated to show certain portions including theleft ventricle 102, theleft atrium 104, the leftatrial appendage 106, thepulmonary artery 108, theaorta 110, theright ventricle 112, theright atrium 114, and the rightatrial appendage 116. As is understood in the art, theleft atrium 104 is located above theleft ventricle 102 and the two are separate by the mitral valve (not illustrated). - First Clip Embodiments
- Referring to FIGS. 2A and 3-7, there is illustrated one embodiment of an occlusion or
closure device 200 sized and configured to close a patent foramen ovale in accordance with one embodiment of the present invention. The closure device preferably comprises a wire shaped to form a clip, which is preferably shaped like a paperclip. As illustrated, in one embodiment the closure device can be considered to have generally an S-shape or two adjacent U-shaped or clip portions, as described further below. Theclosure device 200 has aproximal end 202 and adistal end 204. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter, as described below. - The
closure device 200 generally has three sections: aproximal segment 206, adistal segment 208, and anintermediate segment 210. As illustrated inFIG. 4 , each of these segments is preferably generally annular-shaped or oval-shaped forming a loop, and may be generally parallel to each other when thedevice 200 is in its deployment state, shown inFIG. 2A . It will be appreciated that the segments may have any suitable size and configuration for closing a patent foramen ovale, including round, oblong, rectangular, triangular and square. Each of thesegments wire 212 and may be separately or integrally formed. - In one embodiment, the three
segments distal end 206 b ofproximal segment 206 is connected to aproximal end 210 a ofintermediate segment 210, and adistal end 210 b ofintermediate segment 210 is connected to aproximal end 208 a ofdistal segment 208. As illustrated, thesesegments portions closure device 200 is also preferably provided with adetachment element 214 at itsproximal end 202, illustrated as an externally threaded portion. Alternatively, theproximal end 202 of thedevice 200 may be provided with a threaded aperture through which a delivery core is threadably engaged, a loop or eyelet, or other suitable structure as will be discussed herein for releasably connecting the device to a deployment system. - In one embodiment, a
wire 212 is used to form thesegments closure device 200 need not be formed from a wire, and can be an integral structure, for example, laser cut from a tube or other stock. It is also envisioned that other non-metallic biocompatible materials may be used to formwire 212. Thewire 212 may be solid or hollow. - As shown in
FIG. 4A , in one embodiment at least a portion of thewire 212 is covered with asleeve 224. Thesleeve 224 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials forsleeve 224 can be determined through routine experimentation by those of skill in the art. Thesleeve 224 may be provided on either one or all sections of the closure device. For example, theintermediate segment 210 alone or theentire device 200 may be provided withsleeve 224. In one embodiment, thesleeve 224 comprises two layers. The two layers may be bonded to each other around thewire 212 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. Thesleeve 224 in one embodiment preferably is securely attached to thedevice 200 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. - Referring back to
FIG. 2A , thedevice 200 is illustrated in its deployment state. Thedevice 200 may be self-expanding, having a remembered shape as illustrated inFIG. 2A . Alternatively, thedevice 200 may be mechanically actuated to assume its deployment state. As illustrated, thedevice 200 preferably includes alocking element 228 and retention elements, preferably in the form ofeyelets 230, for retaining thelocking element 228 to theclosure device 200. In one embodiment, theeyelets 230 are offset from one another on adjacent segments of the device. In another embodiment, theeyelets 230 are in line with the longitudinal axis of thedevice 200. Other details regarding a device having eyelets described above, as well as similar devices, may be found in U.S. Pat. Nos. 6,214,029, 6,551,344 and 6,440,152, which are hereby incorporated by reference in its entirety. The lockingelement 228 is used to longitudinally shorten and radially expand the device. The lockingelement 228 preferably comprises a locking string which is preferably used to both longitudinally shorten and radially expand and lock the device at the patent foramen ovale. Other details regarding the locking element described above as well as similar devices may be found in U.S. Pat. No. 5,861,003, which is hereby incorporated by reference in its entirety. Preferably, upon deployment and positioning of thedevice 200, the lockingelement 228 secures the locking string to retain thedevice 200 is the deployed position. The locking string may also be drawn proximally to increase the clamping force of thedevice 200 on the septa of the patent foramen ovale. It will be appreciated that thedevice 200 may still be self-expanding, with the locking string also mechanically actuating thedevice 200. - In some embodiments, the
device 200 may be made by laser cutting flat stock sheet. In another embodiment, thedevice 200 and theeyelets 230 may comprise a metal wire such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. -
FIG. 2B illustrates an alternative embodiment of a self-expanding closure device including at least one eyelet, and more preferably, a plurality ofeyelets 230 to assist with collapse ofdevice 200 into a delivery device. Thedevice 200 may have aproximal segment 206, anintermediate segment 210, and adistal segment 208 like the embodiment ofFIG. 2A , and preferably is formed from a single wire forming three similar shaped segments, which may be generally looped or oval in shape. Theeyelets 230 are integrally formed by small loops made in the wire, preferably at theproximal end 202,distal end 204, and at connectingportions eyelets 230 are configured to receive an actuator orcore 259, such as hypotubing, solid wire or a guidewire, to releasably secure thedevice 200 and stress the wire in a longitudinally stretched position during deployment as shown inFIG. 2B . Upon confirmation of optimal positioning in the patent foramen ovale or other structure, the core may be retracted proximally, thereby releasing thesegments - For use in a patent foramen ovale, the
segments device 200 in one embodiment has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in a further embodiment, about 2.5 cm. When thedevice 200 is longitudinally stretched, the overall length from thedistal end 204 to theproximal end 202 is preferably within the range of about 4 cm to about 20 cm and, in one embodiment, about 8 cm. Preferably thewire 212 has a diameter of 0.001-0.03 in. - Although the
device 200 is shown having a paperclip-like shape, it is envisioned that a number of variations of this shape can be utilized to provide the same results. For example, a bend may be provided in the device to aid in closure. For example, a bend may be placed in theintermediate segment 210, such that thedevice 200 is sized and configured to conform to the shape of the patent foramen ovale. Also, other non-circular or round shapes may be used for each segment, rather than the annular shape, as discussed above. -
FIG. 5 illustrates theclosure device 200 implanted in apatent foramen ovale 120, Thepatent foramen ovale 120 includes aseptum primum 116 having asurface 126 adjacent theleft atrium 104, and aseptum secundum 118 having asurface 124 adjacent theright atrium 114. A tunnel orchannel 122 is located between the septum primum 116 andseptum secundum 118. Theclosure device 200 may be delivered to thepatent foramen ovale 120 using any suitable technique, such as described below. Once positioned, thedistal segment 208 is positioned over thetip 130 of the septum primum 116 and lies along thesurface 126 of theseptum primum 116 adjacent theleft atrium 104. Theintermediate segment 210 lies between the septum primum 116 andseptum secundum 118 inchannel 122. Theproximal segment 206 is positioned over thetip 128 of theseptum secundum 118 and lies along thesurface 124 of theseptum secundum 118 adjacent theright atrium 114. After being delivered, theclosure device 200 exerts a force on the septum primum 116 andseptum secundum 118 to draw the two closer together, either through mechanical actuation or self-expansion of the device. In one embodiment, the proximal and distal segments are identical in shape, and may have identical shapes that form mirror images of each other across the patent foramen ovale to equally apply compressive force to both sides of the patent foramen ovale. - In one embodiment, the
closure device 200 is designed to be implanted using a deployment catheter, such as described with respect toFIGS. 8-12 below. As shown inFIG. 6 , thedevice 200 is designed to remain in a delivery or elongated state while in the catheter (not shown). In this delivery state, thedevice 200 can assume a generally elongate configuration wherein theproximal end 202 anddistal end 204 are pulled apart from each other in a generally linear manner. Upon delivery to the patent foramen ovale, thedevice 200 is radially expanded (FIG. 7 ) into a clip or generally S-shaped configuration to occlude or close the patent foramen ovale. As illustrated, when expanded, the proximal anddistal segments detachment element 214 to a delivery device such as an actuator prior to deployment, and is then detached atdetachment element 214 when properly positioned. In a further embodiment, thedetachment element 214 may use a tether line in addition to or instead of a threaded fitting. Tether lines are described in detail in U.S. Pat. Nos. 6,214,029, 6,440,152, and 6,551,344, which are incorporated in their entirety herein. The procedure for placing the closure device and delivery device will be described in further detail hereinafter. - As shown in
FIGS. 8-11 , a closure device deployment system is provided for delivery of a closure device to a patent foramen ovale. Referring toFIG. 8 , a closuredevice deployment system 240 comprises generally acatheter 242 for placing adetachable closure device 200 within a body cavity or lumen. Thecatheter 242 comprises an elongate flexibletubular body 246, extending between aproximal end 248 and adistal end 250. The catheter is shown in highly schematic form, for the purpose of illustrating the functional aspects thereof. The catheter body will have a sufficient length and diameter to permit percutaneous entry into the vascular system, and transluminal advancement through the vascular system to the desired deployment site. For example, in an embodiment intended for access at the femoral artery and deployment within the patent foramen ovale, thecatheter 242 will have a length within the range of from about 50 cm to about 150 cm, and a diameter of generally no more than about 15 French. Further dimensions and physical characteristics of catheters for navigation to particular sites within the body are well understood in the art and will not be further described herein. - The flexible body can be manufactured in accordance with any of a variety of known techniques. In one embodiment, the
flexible body 246 is extruded from any of a variety of materials such as HDPE, PEBAX, nylon, polyimide, and PEEK. Alternatively, at least a portion or all of the length of the tubular body may comprise a spring coil, solid walled hypodermic needle or other metal tubing, or braided reinforced wall, as are known in the art. - The
tubular body 246 is further provided with ahandle 252 generally on theproximal end 248 of thecatheter 242. Thehandle 252 may be provided with a plurality of access ports. Generally, handle 252 is provided with an access port which may be used as a guidewire port in an over the wire embodiment, and a deployment wire or actuator port. Additional access ports such as a contrast media introduction port, or others may be provided as needed, depending upon the functional requirements of the catheter. Thehandle 252 permits manipulation of the various aspects of the closuredevice deployment system 240, as will be discussed below. Handle 252 may be manufactured in any of a variety of ways, typically by injection molding or otherwise forming a handpiece for single-hand operation, using materials and construction techniques well known in the medical device arts. - An
actuator 244, as described below, is provided in accordance with one embodiment of the present invention, used to releasably engage and deploy theclosure device 200. Any of a variety of structures such as solid cores, polymeric or metal single or multiple strand wires, ribbons, or tubes can be used. Theactuator 244 may be retracted as with a pullwire design, or rotated as with a torque rod design, as will be discussed herein. Theactuator 244 may be hollow or solid. - In use, the deployment catheter is percutaneously introduced into the vascular system and transluminally advanced into the heart and, subsequently, to the patent foramen ovale using techniques which are known in the art.
- The patent foramen ovale may be accessed via catheter through a variety of pathways. It may be accessed from the arterial circuit. The catheter is introduced into the arterial vascular system, preferably in the femoral artery, and guided up the descending thoracic and/or abdominal aorta. The catheter may then be advanced into the left ventricle through the aortic outflow tract. Once in the left ventricle, the catheter may be directed up through the mitral valve and into the left atrium. When the catheter is in the left atrium, it may be directed into the patent foramen ovale and the closure device deployed.
- Alternatively, the patent foramen ovale may be accessed from the venous circuit. The catheter may be introduced into the venous system, preferably in the femoral vein, advanced into the inferior vena cava or superior vena cava and guided into the right atrium. The catheter may then be directed to the patent foramen ovale. Alternatively, once in the right atrium, the catheter may be advanced through the tricuspid valve and into the right ventricle and directed to the ventricular septal defect and the closure device deployed.
- As shown in
FIG. 10 , in a preferred construction, acatheter 242 having a single lumen is illustrated. Also shown is an actuator 244 that acts as the actuator for deploying thedevice 200. In the illustrated embodiment, the actuator may be an elongate body such as a core wire that extends to thehandle 252, and more preferably may be hollow to provide a passageway for thelocking element 228 described with respect toFIG. 2B above. Theactuator 244 may be removably attached to theproximal end 202 or other point of attachment on theclosure device 200, such as through a threaded attachment atdetachment element 214. Proximal retraction of theactuator 244 while resisting proximal motion of theclosure device 200 or distally pulling on the closure device will cause elongating of theclosure device 200 into its delivery state, as has been discussed. Theclosure device 200 is preferably loaded into thedeployment catheter 242 as shown inFIG. 10 . Theactuator 244 may be locked or removably attached with respect to theclosure device 200, and later severed or otherwise detached to enable removal of thedeployment catheter 242 and proximal retraction of theactuator 244. In addition to a threaded connection, locking of theactuator 244 with respect to theclosure device 200 may be accomplished in any of a variety of ways. For example, depending upon the desired catheter design, locking may be accomplished by using interference fit or friction fit structures, tether line, adhesives, a knot, or other technique known to one of ordinary skill in the art. - In the embodiment illustrated in
FIG. 10 , theactuator 244 is releasably connected to the proximal end of theclosure device 200. This permits distal advancement of theclosure device 200 through thecatheter 242 by distal movement of theactuator 244. The proximal end of theactuator 244 may be connected to any of a variety of controls, including rotational knobs, levers and slider switches, depending upon the design preference. To deploy thedevice 200, the actuator is pushed distally untilclosure device 200 exits thecatheter 242. Upon exiting the catheter, the locking element as described above may be actuated to cause the device to move to its deployed configuration. Alternatively, thedevice 200 may self-expand as it exits the catheter. After positioning of the device is confirmed, theactuator 244 is released from thedevice 200, and the actuator and deployment catheter are removed. Where a locking element is used, this locking element may be cut, released or otherwise secured to fix the position of the closure device. Further details on delivery methods are described below with respect toFIGS. 12A-12E . - When delivering a device such as in the embodiment of
FIG. 2B , in another embodiment, adetachment element 214 may be provided that comprises a threaded attachment located on thedistal segment 208. In this embodiment, thecore wire 259 is inserted through theeyelets 230 of theclosure device 200 and is distally threaded to connect with the detachment element, causing elongation of thedevice 200 into its delivery state. Theclosure device 200 is inserted into thedeployment catheter 242 with the core wire inserted through theeyelets 230 of thedevice 200 and attached at thedistal segment 208. The core wire may be advanced out of the deployment catheter to position the closure device in the patent foramen ovale, as discussed below. The core wire may then be detached from thedistal segment 208 and retracted proximally to deploy thedevice 200. A hollow push rod positioned proximal to the closure device and over thecore wire 259 may be used to assist in releasing the closure device from the core wire. Alternatively, the closure device may be positioned distally beyond the distal end of thedeployment catheter 242, and interference between thedeployment catheter 242 and theclosure device 200 may be used to assist in releasing the closure device from the core wire. As discussed, thedetachment element 214 may alternatively comprise a tether line, a threaded fitting, or other technique as is known to one of ordinary skill in the art to releasably secure theclosure device 200 to thecore wire 259. It will also be appreciated that in the embodiment ofFIG. 2B , no detachment element may even be necessary other than theeyelets 230 that secure theclosure device 200 to thecore wire 259. As the core wire is retracted proximally from theeyelets 230 in thesegments device 200 is released to its deployed shape, securing thesepta - The
actuator 244 orcore wire 259 in one embodiment extends axially throughout the length of thecatheter body 246, and is attached at its proximal end to a control on thehandle 252. Theactuator 244 orcore wire 259 may comprise any of a variety of structures which has sufficient lateral flexibility to permit navigation of the vascular system, and sufficient axial column strength to be pushed through thecatheter 242. Any of a variety of structures such as hypotube, solid core wire, “bottomed out” coil spring structures, or combinations thereof may be used, depending upon the desired performance of the finished device. In one embodiment, the core wire comprises stainless steel tubing. - As used herein, the term “core wire” is intended to include any of a wide variety of structures which are capable of transmitting axial tension or compression such as a pushing or pulling force with or without rotation from the
proximal end 248 to thedistal end 250 of thecatheter 242. Thus, monofilament or multifilament metal or polymeric rods or wires, woven or braided structures may be utilized. Alternatively, tubular elements such as a concentric tube positioned within the outertubular body 246 may also be used as will be apparent to those of skill in the art. -
FIGS. 11A-11D illustrate an alternate construction wherein a closure device is biased toward its deployment configuration, such as being made from a shape memory material, and may be radially enlarged or reduced by rotating a torque element extending through the deployment catheter. Referring toFIGS. 11A and 11C , arotatable torque rod 260 extends axially through thedeployment catheter 242, and also extends through theclosure device 200, preferably through at least one internally threaded portion provided in theclosure device 200. For example, as shown inFIG. 11B , an externally threadedportion 262 oftorque rod 260 may engage an internally threaded portion within connectingsegment 211 a. The rotatable torque rod may be encased in a plurality of tubes (not shown) within the closure device that are positioned approximately diametrically within any or all ofsegments torque rod 260 may be connected at a proximal manifold to a manual rotation device such as a hand crank, thumb wheel, rotatable knob or the like. Alternatively, thetorque rod 260 may be connected to a power driven source of rotational energy such as a motor drive or air turbine. - The terms torque rod or torque element are intended to include any of a wide variety of structures which are capable of transmitting a rotational torque throughout the length of a catheter body. For example, solid core elements such as stainless steel, nitinol or other nickel titanium alloys, or polymeric materials may be utilized. In an embodiment intended for implantation over a guidewire, the
torque rod 260 is preferably provided with an axially extending central guidewire lumen. This may be accomplished by constructing thetorque rod 260 from a section of hypodermic needle tubing, having an inside diameter of from about 0.001 inches to about 0.005 inches or more greater than the outside diameter of the intended guidewire.Tubular torque rods 260 may also be fabricated or constructed utilizing any of a wide variety of polymeric constructions which include woven or braided reinforcing layers in the wall. Torque transmitting tubes and their methods of construction are well understood in the intracranial access and rotational atherectomy catheter arts, among others, and are not described in greater detail herein. - One or more distal portions of the torque rod may be threaded as shown in
FIGS. 11B and 11D . More particularly, threadedportions 262 may be provided ontorque rod 260, to correspond to internally threaded portions of the distal segment 208 (FIG. 11D ) or the connectingportions FIG. 11B ). A distal threaded portion or distal rotating coupler, not shown, may be provided at thedistal end 204 of the device to receive the distal end of the torque rod. As will be appreciated by those of skill in the art in view of the disclosure herein, in one embodiment, rotation of thetorque rod 260 in a first direction relative to theclosure device 200 will cause thetorque rod 260 to advance distally. This distal advancement will stress the device and result in an axial elongation and radial reduction of theclosure device 200 as thetorque rod 260 is advanced distally into the threaded apertures of theclosure device 200. Rotation of thetorque rod 260 in a reverse direction will cause a proximal retraction of thetorque rod 260, thus enabling a radial enlargement and axial shortening of theclosure device 200. - In another embodiment, similar to that described with respect to
FIG. 2B above where only thedistal end 204 of thedevice 200 is threaded, the torque rod may be inserted througheyelets 230 formed at theproximal end 202 and connectingsegments device 200, and threadingly engaging thedistal end 204. Disengaging thetorque rod 260 from thedistal segment 208 will release thesegment 208, permitting thesegment 208 to collapse in its deployed position. The remainingsegments torque rod 260 from theeyelets 230 corresponding to eachsegment - With the
torque rod 260 threadingly engaging thedevice 200, upon placement of theclosure device 200 at the desired implantation site, thetorque rod 260 is rotated in a direction that produces an axial proximal retraction. This allows radial enlargement of the radially outwardlybiased closure device 200 at the implantation site. Continued rotation of thetorque rod 260 will cause the threaded portion to exit proximally through the one or more threaded apertures provided on theclosure device 200. - With the
torque rod 260 extending through thedeployment catheter 242, thedevice 200 may be provided beyond the distal end of thedeployment catheter 242, so that when the torque rod is rotated to move the torque rod proximally, the distal force applied by the deployment catheter on thedevice 200 allows the device to release the torque rod. Thedeployment catheter 242 may also be provided with an antirotation lock (not shown) between a distal end of thecatheter 242 and theclosure device 200. In general, the rotational lock may be conveniently provided by cooperation between a first surface on the distal end of thedeployment catheter 242, which engages a second surface on theclosure device 200, to rotationally link thedeployment catheter 242 and theclosure device 200. Any of a variety of complementary surface structures may be provided, such as an axial extension on one of the first and second surfaces for coupling with a corresponding recess on the other of the first and second surfaces. Such extensions and recesses may be positioned laterally offset from the axis of the catheter. Alternatively, they may be provided on the longitudinal axis with any of a variety of axially releasable anti-rotational couplings having at least one flat such as a hexagonal or other multifaceted cross sectional configuration. - Any other means known may be used for temporarily attaching the closure device to a delivery system such as a deployment catheter or actuator. For example, any of a variety of interference fit such as threaded fit or snap fit, pin/loop combinations, interfering diameters, or heat dissociable solders or polymer bonds may be utilized.
- The closure
device deployment system 240 thus permits theclosure device 200 to be maintained in a low crossing profile configuration, to enable transluminal navigation to a deployment site. Following positioning at or about the desired deployment site, distal advancement or proximal retraction of an actuator enables theclosure device 200 to radially enlarge. Radial enlargement in one embodiment occurs under the device's own bias. Alternatively, certain embodiments of the closure device can be enlarged under positive force, such as by inflation of a balloon or by a mechanical mechanism as is discussed elsewhere herein. Once the clinician is satisfied with the position of theclosure device 200, such as by injection of dye and visualization using conventional techniques, the actuator is proximally retracted thereby enabling detachment of theclosure device 200 from thedeployment system 240. - If, however, visualization reveals that the
closure device 200 is not at the location desired by the clinician, theclosure device 200 can be radially reduced and axially elongated, thereby enabling repositioning of theclosure device 200 at the desired site. In the embodiment ofFIG. 10 , this repositioning is allowed by pulling theclosure device 200 partially or wholly back into the catheter before release of the detachment element. In the embodiment ofFIGS. 11A-D , the torque rod can be distally advanced to reengage the internal threading of the closure device. In some embodiments the torque rod will be guided within tubes attached to the segments (discussed previously). Thus, theclosure device 200 can be enlarged or reduced by the clinician to permit repositioning and/or removal of theclosure device 200 as may be desired. - With reference to
FIGS. 12A-12E , a closure device 200 (shown schematically) is preferably positioned within a patent foramen ovale. Initially, thedevice 200 is collapsed inside adeployment catheter 242. Thecatheter 242 is then positioned at or near thepatent foramen ovale 120, as shown inFIG. 12A , more preferably through thechannel 122 between the septum primum and septum secundum. Then, as shown inFIG. 12B , thedistal segment 208 of the device is exposed and is pushed out, preferably using an actuator as described above, and deployed over theseptum primum 116. The deployment catheter is retracted while releasing theintermediate segment 210 to be positioned inside the patent foramen ovale channel 122 (shown inFIG. 12C ), along a surface of the septum primum and the septum secundum. Lastly, theproximal segment 206 is released from the deployment catheter and positioned against the septum secundum 118 (FIG. 12D ). The positioning of each of the segments relative to the septum primum and septum secundum can occur due to a natural bias of the device as it exits the catheter, due to a mechanical actuation of the distal segment into this position, as described above, or due to a combination of natural bias and mechanical actuation. In another embodiment, a core may hold eachsegment device 200 for deployment. - After optimal positioning and closure is achieved, the
device 200 can then be detached from the delivery system, as shown inFIG. 12E . In one embodiment,detachment element 214 comprises a flexible segment such as a hinge or braid to allow thedevice 200 to assume a final implanted attitude without undue distortion applied to the implant or the septa from the deployment catheter. Thedevice 200 can also be captured and retrieved at any time during the procedure as long as it is not fully detached from the delivery system. Once in position, the device clips the patent foramen ovale closed by exerting a force on the septum primum and septum secundum to draw the two together. - With reference to
FIGS. 13-14 , an alternative embodiment of a closure device in accordance with the present invention is shown. Theclosure device 300 preferably is shaped to form a clip-like device, similar to the closure device ofFIG. 2A . The closure device has aproximal end 302 and adistal end 304. The closure device generally has three sections: aproximal segment 306, adistal segment 308, and anintermediate segment 310. In contrast to the device shown inFIG. 2A , in theclosure device 300 shown inFIG. 13 , theintermediate segment 310 is preferably a single straight wire preferably covered in asleeve 324, rather than an elongated annular wire or loop. Theintermediate segment 310 may also be cut from flat stock sheet. Both the proximal anddistal segments segments wire 312 and are connected by connectingportions segments closure device 300 is also preferably provided with adetachment element 314 on proximal end, as discussed above. - When delivered, the
intermediate segment 310 is positioned in the channel between the septum primum 116 and theseptum secundum 118 to close thepatent foramen ovale 120, as was described in the embodiment above. Thedistal segment 308 is preferably positioned in the left atrium, while theproximal segment 306 is positioned in the right atrium. Theclosure device 300 is designed to be implanted using a delivery system, such as described above, and may have a collapsed or delivery state, as shown inFIG. 14 . - Preferably, the
wire 312 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. The wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock. The closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock. - The
intermediate segment 310 is preferably covered with asleeve 324. The wire of the proximal anddistal segments sleeve 324 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials forsleeve 324 can be determined through routine experimentation by those of skill in the art. In one embodiment, thesleeve 324 comprises two layers. The two layers may be bonded to each other around thewire 312 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. Thesleeve 324 in one embodiment preferably is securely attached to thedevice 300 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. In one embodiment, thesegments channel 122 in addition to the closure of the patent foramen ovale induced by the proximal anddistal segments - Preferably, the
device 300 includes alocking element 328 andretention elements 330 for retaining thelocking element 328 to theclosure device 300, as described above. The lockingelement 328 is used to longitudinally collapse the device and hold it in place at the patent foramen ovale. The lockingelement 328 preferably comprises a locking string which is preferably used to both expand and lock the device at thepatent foramen ovale 120. - For use in a patent foramen ovale, the
closure device 300 has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in one embodiment, about 2.5 cm. The overall length of theclosure device 300 from thedistal end 308 to theproximal end 306 is preferably within the range of from about 4 cm to about 20 cm and, in one embodiment, about 8 cm. Preferably the wire has a diameter of 0.001-0.03 in. - Single Clip or Hook Embodiment
- With reference to
FIGS. 15-17 , there is illustrated an additional embodiment of aclosure device 400. The device comprises a proximal or ananterior section 402 and a distal orposterior section 404. Afirst axis 406 passing through theanterior section 402, and asecond axis 408 passing through theposterior section 404, generally parallel to one another, are shown. Theanterior section 402 compriseswings 409, which are used to anchor the device into the correct atrium, preferably the right atrium. Thewings 409 preferably extend to beyond the edges of the patent foramen ovale to provide additional support todevice 400. The anterior andposterior sections tip 130 of theseptum primum 116. The device is provided with aloop 410 integral with the structure to attach thedevice 400 to the delivery device. Theanterior section 402,posterior section 404, andloop 410 are an integral structure and are formed of asingle wire 412. The device is preferably shaped like a hook, as can be seen with reference toFIG. 16 , and is preferably self-expanding into the hook shape. - The
anterior section 402 andposterior section 404 are positioned between the septum primum 116 and theseptum secundum 118 and hook over the septum primum 116 to close apatent foramen ovale 120, as shown inFIG. 17 . This embodiment stabilizes the flap of thepatent foramen ovale 120. Theposterior section 404 is positioned in the left atrium, while theanterior section 402 is positioned in the patent foramen ovale and extends out into the right atrium. Theanterior section 402 is preferably of such a length as to extend along the septum primum 116 to prevent the septum primum 116 from displacing into theleft atrium 104. Theposterior section 404 prevents thetip 130 of the septum primum 116 from displacing into theleft atrium 104 while theanterior section 402 secures thedevice 400 to theseptum primum 116. Theanterior section 402 is preferably sized and configured to extend along theright atrium 114 side of the septum primum 116 such that the base of theseptum primum 116 provides support to thedevice 400, which prevents displacement of theseptum primum tip 130 into theleft atrium 104. - Preferably, the
wire 412 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. The wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock. The closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock. - A portion of the
device 400 is preferably covered with asleeve 424 as shown inFIG. 16 . Thesleeve 424 bridges the fossa andpatent foramen ovale 120, while the wire structure stabilizes the flap of thepatent foramen ovale 120. Thesleeve 424 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials forsleeve 424 can be determined through routine experimentation by those of skill in the art. In one embodiment, thesleeve 424 comprises two layers. The two layers may be bonded to each other around thewire 412 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. Thesleeve 424 in one embodiment preferably is securely attached to thedevice 400 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. - Referring to
FIGS. 18A-E , aclosure device 400 such as described above is preferably positioned within a patent foramen ovale to be closed or occluded. In a patent foramen ovale application, the distal end of adeployment catheter 242 is positioned at or near thepatent foramen ovale 120, as shown inFIG. 18A . The position may be confirmed using fluoroscopy, echocardiography, or other imaging. Thedevice 400 is initially in a collapsed state withincatheter 242, such as described above. Theleft atrium segment 404 of thedevice 400 is exposed and positioned on theseptum primum 116 by advancing or rotating actuator 244 (not shown), as discussed herein. SeeFIG. 18B . Theanterior segment 402 is then positioned inside the patentforamen ovale channel 122 and on theseptum secundum 118 again by advancing or rotating actuator 244 (not shown) (FIG. 18C ). One of ordinary skill in the art will recognize that actuation of thedevice 400 may be accomplished as mentioned above. For example, actuation of thedevice 400 may be mechanically induced, self-expanding, a combination of mechanical and self-expanding. Additionally, deployment and detachment of the device may be accomplished as discussed above. For example, the device may be deployed via a tether line or torque rod, and detached accordingly as discussed previously. In one embodiment, a tether line, core wire orother actuator 244 may be attached toloop 410 for releasably deploying the device. - After optimal positioning and sealing is achieved, as shown in
FIG. 18D , thedevice 400 can then be detached from the delivery system, as shown inFIG. 18E . Thedevice 400 can also be captured and retrieved at any time during the procedure as long as it is not detached from theactuator 244. - Other Clip Embodiments
- Referring to
FIGS. 19-20 , there is illustrated another preferred embodiment of the present invention. Theclosure device 440 comprises a proximal or ananterior section 442, a distal orposterior section 444 and anintermediate section 446. Theposterior section 444 comprises twolegs 449 that extend generally parallel to a longitudinal axis of the device which form an exaggerated “T” shape with theintermediate section 446. Theanterior section 442 has a generally rectangular shape.Sections septum secundum 118. As illustrated, the anchors may be punched in the anterior andintermediate section device 440 surface.Hole 448 may be provided in proximal end ofanterior section 442 to facilitate attachment of a tether and the like toclosure device 440. - The
anterior section 442 is configured and positioned in the right atrium, theposterior section 444 is configured to be positioned in the left atrium, and theintermediate section 446 is configured to be positioned between the septum primum 116 and theseptum secundum 118. Theposterior section 444 hooks over the septum primum 116 and theanterior section 442 hooks over theseptum secundum 118 to occlude or close apatent foramen ovale 120, as shown inFIG. 20 . The septum primum 116 andseptum secundum 118 are held together by the clamping force exerted by the clips defined betweensections sections - In some embodiments, the clip structure can be made by laser cutting flat stock sheet. Preferably, the clip structure comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- Referring to
FIG. 21A , aclosure device 440 is preferably delivered to a defect to be occluded, such as a patent foramen ovale. In a patent foramen ovale application, the distal end of thedeployment catheter 242 is positioned at or near thepatent foramen ovale 120, as shown inFIG. 21A . The position may be confirmed using fluoroscopy, echocardiography, or other imaging. Thedevice 440 is initially in a collapsed state withincatheter 242. Thedevice 440 may be releasably attached to anactuator 244, which may be a push rod. The distal end of thedeployment catheter 242 is advanced between the septum primum 116 andseptum secundum 118 as shown inFIG. 21B . Theposterior portion 444 is advanced out of the distal end of thedeployment catheter 242 and over theseptum primum 116, as shown inFIG. 21C , preferably by withdrawing thecatheter 242 proximally. As thecatheter 242 is withdrawn, theposterior portion 444 flips over into theleft atrium 104 and hooks over theseptum primum 116. Theintermediate section 446 andanterior sections 442 are then delivered, as shown inFIG. 21D , by further withdrawing thecatheter 242 untilanterior section 442 flips over the septum secundum 188. After optimal positioning and sealing is achieved, as shown inFIG. 21D , thedevice 440 can then be detached from the actuator ortether line 260 anddeployment catheter 242. Thedevice 440 can also be captured and retrieved at any time during the procedure as long as it is not detached from the actuator. - In one embodiment, the
device 440, and more particularly theanterior portion 442, has a length L of about 1 inch, thickness t of about 0.02″, and a width W of about 0.475″. The length and width of the anterior portion are preferably greater than the length and width of the posterior portion. More preferably, the anterior portion may be approximately twice as long or greater than the posterior portion, and about 25% or more wider than the posterior portion. - With reference to
FIGS. 22A-C and 23, there is illustrated another preferred embodiment of the present invention. Thedevice 470 is preferably made from a single wire structure, and comprises a proximal or ananterior section 472, a distal orposterior section 474, and anintermediate section 476. Theposterior section 474 compriseswings 479 which are used to anchor the device into the left atrium. Theintermediate section 476 may include crossed wire portions as shown inFIG. 22A or non-crossed wire portions as shown inFIG. 22B . The anterior section may be hexagonal in shape. The anterior, posterior, andintermediate sections loop 480 at a proximal end of the device integral with the structure. Asecond loop 481 may be provided at the intersection of the anterior and intermediate sections. As shown inFIG. 22B , thedevice 470 may also comprise athird loop 484 at the distal end of theposterior section 474. The function of thefirst loop 480,second loop 481, andthird loop 484 will be discussed below with reference to loading and deployment of thedevice 470. Theanterior section 472,posterior section 474,intermediate section 476 and at least oneloop 480 are preferably an integral structure and are formed of asingle wire 482. The device is preferably shaped like a clip, as can be seen with reference toFIG. 23 , when the device is deployed. - As shown in
FIG. 23 , theanterior section 472 is positioned in the right atrium, theposterior section 474 is positioned in the left atrium, and theintermediate section 476 is positioned between the septum primum 116 and theseptum secundum 118. Theposterior section 474 hooks over the septum primum 116 and theanterior section 472 hooks over theseptum secundum 118 to occlude apatent foramen ovale 120, as shown inFIG. 23 . - Preferably, the
wire 482 comprises a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. The wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock. The closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock. - The device may be similarly dimensioned as the embodiment of
FIG. 19A . For use in a patent foramen ovale, the overall width ofdevice 470 may be any value or range of values from about 1 cm to about 5 cm, and, in one embodiment, may be about 2.5 cm. The overall length of theclosure device 470 may be any value or range of values from about 4 cm to about 20 cm and is, in one embodiment, about 8 cm. Preferably the diameter of the wire may be any value or range of values from about 0.001-0.030 in, and in one preferred embodiment is about 0.015 in. - In some embodiments, the
anterior section 472 may have a covering or be laminated.FIGS. 22B and 22C show the device ofFIG. 22B with alaminate structure 483 covering theanterior section 472. In some embodiments, the lamination may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for the lamination material can be determined through routine experimentation by those of skill in the art. In one embodiment, two layers of lamination are provided. The two layers may be bonded to each other around thewire 482 on theanterior section 472 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. The lamination material in one embodiment preferably is securely attached to thedevice 470 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. - Referring to
FIGS. 24A-D , there is illustrated a preferred method of loading the device illustrated inFIG. 22B for delivery. A mountingshaft 486 is inserted through thesecond loop 481 of thedevice 470 such that theanterior section 472 is closer to theproximal end 490 of the mountingshaft 486 and theposterior section 474 is closer to thedistal end 488 of the mountingshaft 486, as shown inFIG. 24A . As shown inFIG. 24B , theposterior section 474 and theintermediate section 476 are bent distally such that each wire of theintermediate section 476 is placed along opposite sides of the mountingshaft 486. The portion between theintermediate section 476 and theposterior section 474 rests on the mountingshaft 486 with thethird loop 484 extending somewhat radially from the mountingshaft 486. Thethird loop 484 is then bent over thedistal end 488 of the mountingshaft 486, as shown inFIG. 24C . - A
tether line 492 is looped through thefirst loop 480 on the proximal end of the device. A recapturewire 494 is inserted through thetether line 492 loop. The recapturewire 494 preferably does not pass through thefirst loop 480 of the device, as shown inFIG. 24D . When thetether line 492 is drawn proximally, the tether line cinches thefirst loop 480 of thedevice 470. Thetether line 492 is then drawn proximally such that theanterior section 472 is an adjacent to the mountingshaft 486. In another embodiment, the mountingshaft 486 may first be inserted through thefirst loop 480 and fixed with atether line 492, followed by the mounting procedure as explained previously. Thedevice 470,tether line 492, recapturewire 494, and mountingshaft 486 are then inserted into a sheath (not shown). - The placement of the
closure device 470 is schematically shown inFIG. 23 . For deployment, the sheath is advanced through thechannel 122 of the patent foramen ovale, such that the distal end of the sheath extends into theleft atrium 104 beyond thetip 130 of theseptum primum 116. The mountingshaft 486 is held in place while the sheath is slowly retracted proximally until theposterior section 474 is released from the sheath. Thewings 479 of theposterior section 474 may be extended out by slightly advancing the sheath distally while holding the mountingshaft 486 in place. The mountingshaft 486 and the sheath are then retracted proximally until thewings 479 of theposterior section 474 engage theseptum primum 116. The mountingshaft 486 is held in place while the sheath is retracted proximally allowing thewings 479 to secure the septum primum. The sheath is then retracted further until theentire device 470 is exposed. - The
tether line 492 and recapturewire 494 are advanced distally, allowing theanterior section 472 to advance and oppose the right atrium side of the septum secundum. With thetether line 492 and recapturewire 494 still secured to thefirst loop 480, theentire device 470 may be recaptured if required. Thetether line 492 and recapturewire 494 may also assist in repositioning theanterior section 472 of the device. Optimal positioning of the device may be confirmed using fluoroscopy, echocardiography, or other imaging. Once optimal positioning is confirmed, the mounting shaft is retracted proximally, and the recapturewire 494 is withdrawn proximally to release thetether line 492 loop. The mountingshaft 486,tether line 492, recapturewire 494, and sheath are then removed. - Referring to
FIGS. 25-32 , there is illustrated another preferred embodiment of the present invention. The device is shown in an unexpanded state inFIGS. 25 and 26 . Aclosure device 500 is provided having a softdistal tip 502, connected to adistal hub 504, and a softproximal tip 506, connected to aproximal hub 508. The device also comprises at least two sealingarms 510. The sealingarms 510 are preferably heat-set. When the device is expanded, thearms 510 have a generally round shape, as shown inFIG. 27 . Thedevice 500 also comprises at least twoanchors proximal hubs arms 510. The anchors deflect outwards upon expansion to retain the septum primum 116 andseptum secundum 118, as will be described. Thedevice 500 is preferably made from a laser-cut hypotube. Thedistal hub 504 andproximal hub 508 are drawn together, thereby compressing thedevice 500 and expanding the sealingarms 510 for positioning in apatent foramen ovale 120channel 122. - Preferably, the
closure device 500 is provided with one or more retention structures for retaining the device in the patent foramen ovale or other similar septal defects. SeeFIG. 26 . In the illustrated embodiment, a plurality of barbs or other anchoringelements 522 are provided, for engaging adjacent tissue to retain theclosure device 500 in its implanted position and to limit relative movement between the tissue and the closure device. The illustratedbarbs 522 are provided on theanchors - The
arms 510 are preferably positioned in thechannel 122 between the septum primum 116 and theseptum secundum 118 to close thepatent foramen ovale 120, as shown inFIG. 28 . Afirst anchor 513 is positioned in the left atrium, while asecond anchor 512 is positioned in the right atrium. Theanchors septum secundum 118, to close thepatent foramen ovale 120. - Preferably, the
device 500 is formed of a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. The material may also be biodegradable. Material having a circular, rectangular, or other cross-section may be utilized depending upon the manufacturing technique. One of ordinary skill in the art will recognize various methods of manufacturing thedevice 500. In one embodiment, for example, material with a circular cross section is cut such as by known laser cutting techniques from tube stock. The closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock. - The device may also comprise a sleeve over at least a portion of the device. The sleeve may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for sleeve can be determined through routine experimentation by those of skill in the art. In one embodiment, the sleeve comprises two layers. The two layers may be bonded to each other around the device in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. The sleeve in one embodiment preferably is securely attached to the
device 500 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. - The
device 500 is further provided with an expansion anddetachment element 514 at its distal end. The expansion anddetachment element 514 may be either a pull wire design (FIGS. 29-30 ), a turn screw design (FIGS. 31-32 ), a tether line, or other method known by one of ordinary skill in the art that may be used to collapse and lock the closure device in its expanded state. In one embodiment, the device is preferably attached viadetachment element 514 to a delivery system as described above prior to deployment, and is then detached atdetachment element 514 when properly positioned. The device can then be detached from the delivery system at the same place. In one embodiment, deployment and detachment of the device may be accomplished by torque rods, as discussed previously with reference toFIGS. 11A-B . In another embodiment, deployment and detachment may be accomplished by tether lines as previously discussed. Other methods that are known by one of ordinary skill in the art may also be used. - Umbrella and Acorn Embodiments
- Referring to
FIGS. 33-34 , alternate structures of a closure device in accordance with the present invention are illustrated. Theclosure device 600 comprises an occludingmember 602 comprising aframe 604 and abarrier 606. In the illustrated embodiment theframe 604 comprises a plurality of radially outwardly extendingspokes 608 each having a length within the range of from about 1 cm to 6 cm. The device has aproximal end 610 and adistal end 612 corresponding to aproximal hub 614 and adistal hub 616. Acentral hub 618 is also preferably provided between theproximal hub 614 anddistal hub 616. Theframe 604 andbarrier 606 form aproximal segment 620 and adistal segment 622. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. Proximal anddistal segments septum secundum 118 on both sides, thus sealing the patent foramen ovale. - The
spokes 608 are advanceable from a generally axially extending orientation such as from within a tubular introduction catheter to a radially inclined orientation. In a self-expandable embodiment, the spokes are biased radially outwardly such that the closure member expands to its enlarged, implantation cross-section under its own bias following deployment from the catheter. Alternatively, the closure member may be enlarged using any of a variety of enlargement structures such as an inflatable balloon, or a catheter for axially shortening the closure member, as is discussed further below. In yet a further embodiment, expansion of the device may be accomplished by torque rods, as discussed previously with reference toFIGS. 11A-B . Theproximal hub 614 may threadingly engage the torque rod such that rotation of the torque rod will expand or contract thedevice 600. Thedistal hub 616 may operate to support the distal end of the torque rod, permitting the torque rod to rotate freely upon its axis with thedistal hub 616. In another embodiment, thedistal hub 616 may also be threadingly engaged to the torque rod. - For deployment, the
device 600 is preferably advanced through thechannel 122 of thepatent foramen ovale 120 until the distal end of the catheter is beyond thetip 130 of theseptum primum 116. Thedevice 600 is preferably advanced until thedistal end 616 of thedevice 600 extends into theleft atrium 104. Thedistal segment 622 is exposed from the catheter, such that it expands to its enlarged, implantation cross-section and engages the septum primum 116 wall on theleft atrium 104 side. Thedevice 600 then is then drawn proximally to draw theseptum primum 116 toward theseptum secundum 118, closing thechannel 122. Theproximal segment 620 of thedevice 600 is then exposed and permitted to expand to its enlarged, implantation cross-section, securing theseptum secundum 118 to theseptum primum 116. - Depending upon the desired introduction crossing profile of the
collapsed closure device 600, as well as structural strength requirements in the deployed device, anywhere within the range of from about 3 spokes to about 40 spokes may be utilized. In some embodiments, anywhere from about 12 to about 24 spokes are utilized, and 18 spokes are utilized in one embodiment. - Preferably, the spokes comprise a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, rectangular cross section spokes are cut such as by known laser cutting techniques from tube stock, a portion of which forms the
hubs - The
barrier 606 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials forbarrier 606 can be determined through routine experimentation by those of skill in the art. Thebarrier 606 may be provided on either one or preferably both axially facing sides of the closure member. In one embodiment, thebarrier 606 comprises two layers, with one layer on each side of theframe 604. The two layers may be bonded to each other around thespokes 608 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. Thebarrier 606 preferably has a thickness of no more than about 0.003 in. - For use in a patent foramen ovale, the occluding
member 600 has an expanded diameter within the range of from about 10 mm to about 40 mm, and, in one embodiment, about 20 mm. The overall length of theclosure device 600 from thedistal end 612 to thedistal end 610 is within the range of from about 40 mm to about 100 mm and, in one embodiment, about 70 mm. - Modifications to the closure device are illustrated in
FIGS. 35-36 . Theclosure device 650 comprises aclosure member 652 comprising aframe 654 and abarrier 656. In the illustrated embodiment theframe 654 comprises a plurality of radially outwardly extendingspokes 658. The device has aproximal end 660 and adistal end 662, corresponding to aproximal hub 664 and adistal hub 666. Acentral hub 668 is also preferably provided between theproximal hub 664 anddistal hub 666. Theframe 654 andbarrier 656 form aproximal segment 670 and adistal segment 672. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. Proximal anddistal segments device 650 preferably corresponds to the deployment discussed above with reference toFIGS. 33-34 . - Referring to FIGS. 37 and 38A-B, a further variation of the closure device is shown. The
closure device 700 comprises aclosure member 702 comprising aframe 704 and abarrier 706. In one embodiment, theframe 704 comprises a plurality of radially outwardly extending supports (not shown). The device has aproximal end 710 and adistal end 712 corresponding to aproximal hub 714 and adistal hub 716. A softdistal tip 718 is also preferably provided at thedistal end 712, and is connected todistal hub 716. Theframe 704 andbarrier 706 form aproximal segment 720 and adistal segment 722. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. Proximal anddistal segments - With reference to
FIG. 38A , the device is shown in an unexpanded state. Proximal retraction on thedeployment line 730 while resisting proximal movement ofproximal hub 714 such as by using the distal end of thecatheter 732 will cause thedistal hub 716 to be drawn towards theproximal hub 714, thereby radially enlarging the cross-sectional area of theclosure device 700, as shown inFIG. 38B . Depending upon the material utilized for theclosure device 700, the supports 708 will retain the radially enlarged orientation by elastic deformation, or may be retained in the enlarged orientation such as by securing a slip knot immovably to thedeployment line 730 at the fully radially enlarged orientation. This may be accomplished in any of a variety of ways, using additional knots, clips, adhesives, or other techniques known in the art. A variety of alternative structures may be utilized, to open or enlarge theclosure device 700 under positive force, such as using a pullwire or a torque element, as will be discussed in further detail hereinafter. Deployment of thedevice 700 preferably corresponds to the deployment discussed above with reference toFIGS. 33-34 . - With reference to
FIGS. 39-41 , theclosure device 750 comprises an occludingmember 752 comprising aframe 754 and abarrier 756. In the illustrated embodiment theframe 754 comprises a plurality of radially outwardly extendingspokes 758. The device has a proximal end 760 adistal end 762 corresponding to aproximal hub 764 and adistal hub 766. Acentral hub 768 is also preferably provided between theproximal hub 764 anddistal hub 766. A softdistal tip 769 is also preferably provided at thedistal end 762, and is connected todistal hub 766. Theframe 754 andbarrier 756 form aproximal segment 770 and adistal segment 772. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. Proximal anddistal segments distal segments surface 774 and convex outwardly facingsurface 776. The device is shown in a collapsed state inFIG. 41 . Deployment of thedevice 750 preferably corresponds to the deployment discussed above with reference toFIGS. 33-34 . - Referring to
FIGS. 42-43 and 45, a variation of the closure device is shown. Theclosure device 800 comprises aframe 804 and abarrier 806. In the illustrated embodiment theframe 804 comprises a plurality of radially outwardly extendingspokes 808. The device has a proximal end 810 adistal end 812 corresponding to aproximal hub 814 and adistal hub 816. Theframe 804 andbarrier 806 form aproximal segment 820 and adistal segment 822. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. Proximal anddistal segments distal segments surface 824 and an angled outwardly facingsurface 826. Thedevice 800 is shown in a collapsed position inFIG. 45 . Deployment of thedevice 800 preferably corresponds to the deployment discussed above with reference toFIGS. 33-34 . - Referring to
FIGS. 44A-C , aclosure device 1400 is preferably positioned within a septal defect to be occluded, such as a patent foramen ovale or an atrial septal defect. In a patent foramen ovale application, thedistal end 1402 of thedelivery catheter 1404 is positioned at or near thepatent foramen ovale 120. The position may be confirmed using fluoroscopy, echocardiography, or other imaging. Thedevice 1400 is initially in a collapsed state incatheter 1404. The actuator 1408 (shown inFIG. 44C ) is thereafter proximally retracted or rotated, as with a torque rod, to place and expand theclosure device 1400 at thepatent foramen ovale 120. - As will be apparent from
FIG. 44B , proximal retraction or rotation on theactuator 1408 while resisting proximal movement ofproximal hub 1410 such as by using the distal end of thecatheter 1404 will cause thedistal hub 1412 to be drawn towards theproximal hub 1410. Theclosure device 1400 engages the septa walls thereby closing the patent foramen ovale. - The actuator may then be locked with respect to the proximal hub and severed or otherwise detached to enable removal of the deployment catheter and proximal extension of the actuator. Locking of the
actuator 1408 with respect to theclosure device 1400 may be accomplished in a variety of ways, such as by using interference fit or friction fit structures, adhesives, a knot or other techniques depending upon the desired catheter design, as discussed herein. After thedevice 1400 is locked in placed, thecatheter 1402 is detached from thedevice 1400 and removed from the patient. SeeFIG. 44 . Thedevice 1400 can also be captured and retrieved at any time during the procedure as long as it is not detached from the delivery catheter. - With reference to
FIG. 46 , an alternative embodiment of the closure device is shown. Theclosure device 850 comprises a proximalinflatable balloon 852 and a distalinflatable balloon 854 joined together at acentral hub 856. Thedevice 850 may also comprise a frame, comprising a plurality of supports. Thedevice 850 is preferably expanded by inflating theballoons inflation lumen 858. Thecentral hub 856 is positioned within the patent foramen ovale, while theproximal balloon 852 is preferably positioned in the right atrium and thedistal balloon 854 is positioned in the left atrium, to occlude the patent foramen ovale. - Any modifications to the device to accommodate these various aspects of the closure device as discussed herein may be readily accomplished by those of skill in the art in view of the disclosure herein.
- Tack Embodiments
- With reference to
FIGS. 47 and 48 , alternative embodiments are shown. In these embodiments, the patent foramen ovale is simply held together by positioning adevice septum secundum 118 together. In a first embodiment, thedevice 900 comprises aproximal end 906 and adistal end 908, having aproximal anchor 910 and adistal anchor 912. Alternatively, adevice 950 comprises aproximal end 956 and adistal end 958. The device has a screw-like configuration and comprises a coiled wire or threadedscrew 960. Theproximal end distal end device detachment zone - Preferably, the
device - In another preferred embodiment, with reference to
FIGS. 49-51 , aclosure device 1000 comprising a closure member is shown. The device comprises aproximal end 1002 and adistal end 1004, and acircular proximal section 1006 and circulardistal section 1008, which are connected via acenter strut 1010, forming an integral structure. Thecenter strut 1010 preferably contains a closure orthrombotic material 1011. Aloop 1012 is provided for holding and retrieving thedevice 1000. The proximal anddistal sections - The
center strut 1010 rests within thepatent foramen ovale 120 for occluding thechannel 122, engaging the septum primum 116 and theseptum secundum 118. Theproximal section 1006 is preferably positioned in the right atrium, while thedistal section 1008 is positioned in the left atrium. - Preferably, the
device 1000 is formed of a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. The wire may also be biodegradable. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one embodiment, a circular cross section wire is cut such as by known laser cutting techniques from tube stock. The closure device is preferably an integral structure, such as a single ribbon or wire, or element cut from a tube stock. - The
thrombotic material 1011 may include DACRON™, or others which can be determined through routine experimentation by those of skill in the art. - Channel-Filling Embodiments
- With reference to
FIG. 52 , there is illustrated another preferred embodiment of the present invention. Aclosure device 1050 comprising a porous sponge or sponge-like material is shown. Alternatively, theclosure device 1050 may comprise a fluid-filled bag with a porous or semi-porous other covering. In some embodiments, theclosure device 1050 has a generally cylindrical shape. In some embodiments, the sponge is at least as large as the defect to be filled. In some embodiments,tether 1055 extends throughclosure device 1050 and is used to attachclosure device 1050 todelivery catheter 1504.FIG. 53 illustrates the sponge-like closure device 1050 positioned at a patent foramen ovale. The sponge expands upon placement to close the defect and is secured in place by the septum primum 116 andseptum secundum 118. - In some embodiments, the sponge or sponge-like material may comprise collagen, PE, PTFE, Poly Vinyl Acetate (Ivalon), or Ethyl Vinyl Acetate. In some embodiments, the material may be bioresorbable. In some embodiments, the sponge promotes tissue ingrowth for more complete sealing of a septal defect, such as a patent foramen ovale.
- With reference to
FIG. 54 , ananchor device 1060 is illustrated. Theanchor device 1060 comprises aframe 1062 having a plurality ofretention elements 1064 provided thereon. In some embodiments, the frame may be perforated, while in other embodiments, the frame is solid. - In some embodiments, the
anchor device 1060 may be comprised of a plurality of laser cut strips 1065, as shown inFIG. 55 . The laser cut strips comprise a laser-cut body 1066 which can be twisted to revealanchors 1068. A detailed view of thebody 1066 and anchors 1068 is shown inFIG. 56 . By linking together a plurality of the laser cut strips 1065, a lattice of anchoring surfaces can be formed. The lattice of anchoring surfaces can also be placed within or through a patent foramen ovale. - As shown in
FIG. 57 , theanchor device 1060 may be used with the sponge-like closure device 1050 to form an anchoredsponge closure device 1070. The anchors may be used to further secure the sponge-like closure device in place.FIG. 58 illustratesclosure device 1070, whereinanchor devices 1060 secure the sponge-like closure device 1050 at a defect. - Referring to
FIG. 59A-C , a preferably method is shown of deploying theclosure device 1500 within a septal defect, such as a patent foramen ovale. In a patent foramen ovale application, thedistal end 1502 of thedelivery catheter 1504 is positioned at or near thepatent foramen ovale 120, as shown inFIG. 59A . The position may be confirmed using fluoroscopy, echocardiography, or other imaging. Thedevice 1500 is initially in a collapsed state withincatheter 1504. Thedevice 1500 may be releasably attached to anactuator 1508. Thedistal end 1502 of thedelivery catheter 1504 is advanced between the septum primum 116 andseptum secundum 118 as shown, and theposterior portion 1510 is advanced out of thedistal end 1502 of thedelivery catheter 1504, as shown inFIG. 59B . The intermediate section and posterior sections are then delivered, as shown inFIG. 59C . After optimal positioning and sealing is achieved, thedevice 1500 can then be detached from thedelivery catheter 1504. - Any of the closure devices disclosed herein may also be coated with a therapeutic substance, such as an anti-thrombogenic drug. The therapeutic substances are typically either impregnated into the device or carried in a polymer that coats the device. The therapeutic substances are released from the device or polymer once it has been implanted in the vessel. The device may be impregnated with at least one drug or coated with at least one drug by any known process in the art. The drug may be carried in a volatile or non-volatile solution. As used in this application, the term “drug” denotes any compound which has a desired pharmacological effect, or which is used for diagnostic purposes.
- Furthermore, the closure devices as disclosed herein are preferably asymmetrical. As has been discussed, the axis of a patent foramen ovale tends to be at an angle, and almost parallel to the septal wall. Accordingly, asymmetrical closure devices will be effective in closing septal defects having non-longitudinal axes, such as a patent foramen ovale.
- As a post implantation step for any of the closure devices disclosed herein, a radiopaque dye or other visualizable media may be introduced on one side or the other of the closure device, to permit visualization of any escaped blood or other fluid past the closure device. For example, in the context of a patent foramen ovale application, the closure device may be provided with a central lumen or other capillary tube or aperture which permits introduction of a visualizable dye from the deployment catheter through the closure device and into the space on the distal side of the closure device.
- While particular forms of the invention have been described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims (19)
1-7. (canceled)
8. A system for closing a patent foramen ovale with an overlapping septum primum and a septum secundum, comprising:
a delivery catheter having a lumen extending therethrough;
a closure device configured for being configured for placement in the opening in the heart and for collapsible containment within the lumen, the closure device comprising:
a wire;
an anterior section;
a posterior section;
at least one loop;
at least one wing configured to anchor the device into heart tissue; and
a tether extending through the at least one loop, the tether configured to releasably retain the closure device with the delivery catheter.
9. The system for closing a patent foramen ovale of claim 8 , wherein the tether extends through the lumen and is detachable from the at least one loop.
10. The system for closing a patent foramen ovale of claim 8 , wherein the closure device is self-expandable.
11. The system for closing a patent foramen ovale of claim 8 , wherein the wire, anterior section, posterior section and at least one loop are integral.
12. The system for closing a patent foramen ovale of claim 8 , wherein the wire comprises Nitinol.
13. The system for closing a patent foramen ovale of claim 8 , wherein the wire comprises stainless steel.
14. The system for closing a patent foramen ovale of claim 8 , the wings extending beyond the overlapping septum primum and a septum secundum of the patent foramen ovale to provide additional support to closure device.
15. The system for closing a patent foramen ovale of claim 8 , further comprising a material attached to the closure device configured to facilitate cellular in-growth.
16. A system for closing a defect in a human heart, comprising:
a wire frame having expandable anterior and posterior sections, wherein the wire frame is biased to be expanded such that the anterior and posterior sections engage tissue on opposite sides of the defect, and the wire frame is configured to be retrieved by collapsing the wire frame;
at least one loop in the anterior section of the wire frame;
at least one wing configured to anchor the device into heart tissue; and
a tether passing through the at least one loop; and
a delivery catheter having a lumen for delivering the wire frame in a collapsed configuration to the defect.
17. The system of claim 16 , wherein the posterior section includes a plurality of loops extending radially outwardly.
18. The system of claim 16 , further comprising a material on at least a portion of the wire frame configured to promote tissue growth.
19. The system of claim 18 , wherein the material is formed of a relatively porous material for permitting ingrowth of collagen or fibrous tissue into the material.
20. The system of claim 16 , comprising a plurality of loops in the anterior section of the wire frame and a plurality of tethers passing through the loops.
21. A tissue opening occluder for placement in an area formed by overlapping atrial septa of a patent foramen ovale (PFO), the overlapping atrial septa forming a PFO tunnel, the PFO tunnel having a generally planar geometry along a length of the tunnel from the left atrium to the right atrium, the tissue opening occluder comprising:
a planar support structure sized and configured to be deployed into position within the PFO tunnel between the overlapping atrial septa with a planar portion of the planar support structure configured to be generally parallel with a tissue wall extending along a length of the PFO tunnel from the left atrium to the right atrium, the planar portion comprising a first substantially planar tissue engaging side and a second substantially planar tissue engaging side, the planar portion having a flat configuration defined between the first and second substantially planar tissue engaging sides;
at least one wing configured to anchor the device into heart tissue; and
a material supported by the planar support structure and sized and configured to be positioned within the PFO tunnel between the overlapping atrial septa, the material promoting tissue growth to anchor the occluder in intimate contact with a tissue wall.
22. The tissue opening occluder of claim 21 , wherein the material is porous.
23. The tissue opening occluder of claim 21 , wherein the support structure is made of metal wire.
24. The tissue opening occluder of claim 21 , wherein the planar support structure further comprises at least one loop selectively attachable to a tether.
25. The tissue opening occluder of claim 21 , wherein the planar support structure further comprises wings configured to anchor the support structure into heart tissue.
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EP1596723A2 (en) | 2005-11-23 |
US20040220596A1 (en) | 2004-11-04 |
WO2004069055A3 (en) | 2004-12-09 |
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