US20140052174A1 - Devices and methods for closure of a patent foramen ovale - Google Patents
Devices and methods for closure of a patent foramen ovale Download PDFInfo
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- US20140052174A1 US20140052174A1 US14/067,255 US201314067255A US2014052174A1 US 20140052174 A1 US20140052174 A1 US 20140052174A1 US 201314067255 A US201314067255 A US 201314067255A US 2014052174 A1 US2014052174 A1 US 2014052174A1
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- wing
- arm
- closure device
- pfo
- septum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00619—Locking means for locking the implement in expanded state
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
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- Animal Behavior & Ethology (AREA)
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Abstract
The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.
Description
- Patent foramen ovale (“PFO”) is an anatomical interatrial communication with potential for right-to-left shunting of blood. Specifically, PFO is a flap-like opening between the atrial septa primum and secundum of the heart that persists after one year of age. In utero, the foramen ovale serves as a physiologic conduit for right-to-left shunting of blood in the fetal heart. After birth, with the establishment of pulmonary circulation, the increased left atrial blood flow and pressure presses the septum primum against the walls of the septum secundum, covering the foramen ovale and resulting in functional closure of the foramen ovale. This closure is usually followed by anatomical closure of the foramen ovale due to fusion of the septum primum to the septum secundum.
- If anatomical closure of the foramen ovale does not occur, a patent foramen ovale is created. A PFO results when either partial or no fusion of the septum primum and the septum secundum occurs. In the case of partial or no fusion, a persistent passageway or PFO track exists between the septum primum and the septum secundum. The passageway is typically parallel to the plane of the septum primum, and has a mouth that is generally oval in shape. Normally, the passageway is long and quite narrow. Because the mean left atrial pressure is typically higher than the mean right atrial pressure, the opening is usually held closed. However, at times, the mean right atrial pressure may exceed the mean left atrial pressure, causing the PFO track to open and allow the passage of blood (and possible blood clots) from the right atrium to the left atrium (and into systemic circulation). Although the PFO track is often held closed, the endothelialized surfaces of the tissues forming the PFO track prevent the tissues from healing together and permanently closing the PFO track.
- Studies have shown that a relatively large percentage of adults have a patent foramen ovale. It is believed that embolism via a PFO may be the cause of a significant number of ischemic strokes, particularly in relatively young patients. Such paradoxical embolism via PFO is considered in the diagnosis of patients who have suffered a stroke or transient ischemic attack (“TIA”) in the presence of a PFO and without another identified cause of ischemic attack. Blood clots that form in the venous circulation can embolize, and may enter the arterial circulation via the PFO, subsequently entering the cerebral circulation, resulting in an embolic stroke. Blood clots may also form in the vicinity of the PFO, and embolize into the arterial circulation and into the cerebral circulation. Patients suffering a cryptogenic stroke or TIA in the presence of a PFO are often considered for medical therapy to reduce the risk of a recurrent embolic event. Pharmacological therapy often includes oral anticoagulants or antiplatelet agents to block the formation of emboli. If pharmacotherapy is unsuitable, open heart surgery may be employed to close a PFO with stitches, for example. Like other open surgical procedures, this surgery is highly invasive, risky, requires general anesthesia, and may result in a lengthy recuperation.
- Nonsurgical closure of a PFO is possible with umbrella-like devices and a variety of similar mechanical closure devices originally developed for percutaneous closure of atrial septal defects (“ASD”), a condition where the septum primum is often under-developed and perforated. Many of the devices used for closure of an ASD, however, are often technically complex to manufacture and assemble, have a high septal profile, are difficult to deploy to a precise location, and are difficult to implant without deforming the atrial septa and PFO track. In addition, such devices may be difficult or impossible to reposition or retrieve in cases where the original positioning was unsatisfactory. Moreover, these devices are specially designed to close ASDs, or hole-like defects, and therefore are not optimally designed to close and seal a PFO, an overlapping, flap-like, passageway defect. Thus, when inserting an ASD device to close a PFO, the narrow opening and thin flap may form impediments to proper deployment of the device, resulting in residual leakage through the PFO. Even if an occlusive seal is formed, the device may be deployed in the PFO track at an angle, leaving some components insecurely seated against the septum and thereby increasing the risk of thrombus formation due to hemodynamic disturbances.
- Accordingly, there exists a need for instrumentation and techniques that facilitate more effective and efficient closure of aberrant, flap-like bodily openings such as patent foramen ovales.
- This disclosure relates to a closure device for closing physical anomalies and defects, including a patent foramen ovale, an atrial septal defect, and various other septal and vascular defects.
- In one exemplary aspect, the present disclosure is directed to a device for closing a patent foramen ovale (PFO). The device may comprise a first arm, a second arm, a first wing, and a second wing. The first arm may include a first body portion and a first tab portion, wherein the first body portion may include a first passage extending longitudinally therethrough. The second arm may include a second body portion and a second tab portion, wherein the second body portion may include a second passage extending longitudinally therethrough. The second passage may be sized to slidably receive the first tab portion and the first passage may be sized to slidably receive the second tab portion. The first wing may be pivotally connected to the first arm and the second wing may be pivotally connected to the second arm.
- In another exemplary aspect, the present disclosure is directed to a device for closing a patent foramen ovale (PFO). The device may comprise a first arm and a second arm. The first arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a first wing via a first hinge and the first hinge includes a first projection. The second arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a second wing via a second hinge and the second hinge includes a second projection. The distal end of the first arm may be configured to engage the second projection to pivot the second wing with respect to the second arm, and the distal end of the second arm may be configured to engage the first projection to pivot the first wing with respect to the first arm.
- In another exemplary aspect, the present disclosure is directed to a system for closing a patent foramen ovale (PFO) in a heart. The system may comprise a delivery catheter, a closure device, an outer tool, and an inner tool. The delivery catheter may have a lumen extending along a longitudinal axis. The closure device may be configured for delivery into the heart and for collapsible containment within the lumen. The closure device may comprise a first arm, a second arm, a first wing, and a second wing. The first arm may include a first body portion and a first tab portion, wherein the first body portion may include a first passage extending longitudinally therethrough. The second arm may include a second body portion and a second tab portion, wherein the second body portion may include a second passage extending longitudinally therethrough. The second passage may be sized to slidably receive the first tab portion and the first passage may be sized to slidably receive the second tab portion. The first wing may be pivotally connected to the first arm and the second wing may be pivotally connected to the second arm. The outer tool may be configured for attachment to the first body portion and have a lumen extending longitudinally through its length. The inner tool may be configured for attachment to the second tab portion. The lumen of the outer tool may be sized to receive a portion of the inner tool, wherein the inner tool is movable with respect to the outer tool to slide the second tab portion with respect to the first passage.
- In another exemplary aspect, the present disclosure is directed to a system for closing a patent foramen ovale (PFO) in a heart. The system may comprise a delivery catheter, a closure device, an outer tool, and an inner tool. The delivery catheter may have a lumen extending along a longitudinal axis. The closure device may be configured for delivery into the heart and for collapsible containment within the lumen. The closure device may comprise a first arm and a second arm. The first arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a first wing via a first hinge and the first hinge includes a first projection. The second arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a second wing via a second hinge and the second hinge includes a second projection. The distal end of the first arm may be configured to engage the second projection to pivot the second wing with respect to the second arm, and the distal end of the second arm may be configured to engage the first projection to pivot the first wing with respect to the first arm. The outer tool may be configured for attachment to the proximal end of the first arm and have a lumen extending longitudinally through its length. The inner tool may be configured for attachment to the distal end of the second arm. The lumen of the outer tool may be sized to receive a portion of the inner tool, wherein the inner tool is movable with respect to the outer tool to slide the distal end of the second arm with respect to the first hinge.
- In another exemplary aspect, the present disclosure is directed to a method for closing a patent foramen ovale (PFO) in a heart, where the PFO comprises a lumen between a septum primum and a septum secundum. The method may include the steps of: providing a closure device comprising a first wing, a first arm, a second arm, and a second wing; providing an assembly sheath having a lumen extending longitudinally through its length, the lumen sized and configured to contain the closure device in a collapsed configuration; providing a delivery catheter having a lumen extending longitudinally through its length, the lumen sized and configured to contain the assembly sheath; inserting the closure device into the lumen of the assembly sheath such that the closure device is in a collapsed configuration; advancing the delivery catheter into a desired location within the heart; connecting the assembly sheath to the delivery catheter; advancing the closure device through the assembly sheath into the delivery sheath; delivering the closure device at least partially within the PFO; withdrawing the delivery catheter such that the first arm and the second arm are positioned within the lumen of the PFO, the second wing is positioned in a left atrium of the heart, and the first wing is positioned in a right atrium of the heart; rotating the closure device such that the first wing and the second wing are about parallel to the septum secundum and the septum primum, respectively; and interlocking the first arm and second arm such that the second wing is positioned against the septum primum and the first wing is positioned against the septum secundum, wherein the first wing and the second wing exert force on the septum secundum and septum primum, respectively, to push overlapping layers of the septum secundum and the septum primum together to close the PFO.
- In another exemplary aspect, the present disclosure is directed to a method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum. The method may include the steps of: providing a first closure component including a first body portion connected between a first tab and a first wing, the first body portion including a first passage extending longitudinally therethrough; providing a second closure component including a second body portion connected between a second tab and a second wing, the second body portion including a second passage extending longitudinally therethrough; positioning the first and second body and tab portions into the patent foramen ovale; sliding the second tab portion within the first passage; sliding the first tab portion within the second passage; engaging the septum primum between the first and second body portions and the first wing; and engaging the septum secundum between the first and second body portions and the second wing.
- In another exemplary aspect, the present disclosure is directed to a method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum. The method may include the steps of: providing a first arm with proximal and distal ends, the proximal end pivotally connected to a first wing via a first hinge, the first hinge including a first projection; providing a second arm with proximal and distal ends, the proximal end pivotally connected to a second wing via a second hinge, the second hinge including a second projection; engaging the distal end of the first arm with the second projection to rotate the second wing with respect to the second arm; and engaging the distal end of the second arm with the first projection to rotate the first wing with respect to the first arm.
- Further aspects, forms, embodiments, objects, features, benefits, and advantages of the present invention shall become apparent from the detailed drawings and descriptions provided herein.
- Aspects of the present disclosure are best understood from the following detailed description when read with the accompanying figures. It is emphasized that various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. In addition, the present disclosure may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.
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FIG. 1 is a perspective view of a first embodiment of the closure device. -
FIG. 2 is an exploded view of the arms of the first embodiment of the closure device. -
FIGS. 3 a-3 c are detailed views of the linkage between the arms of the first embodiment of the closure device.FIG. 3 a is a perspective view, andFIGS. 3 b-3 c are cross-sectional side views. -
FIG. 4 is a perspective view of a hinge mechanism between the first arm and a first wing of the first embodiment of the closure device. In addition,FIG. 4 is a perspective view of outer and inner connector members attached to portions of the first arm and the second arm, respectively. -
FIGS. 5-10 are perspective views illustrating a first embodiment of a compression apparatus and the preparation of the first embodiment of the closure device for delivery. -
FIGS. 11 a-11 i are partial cross-sectional views illustrating a second embodiment of a compression apparatus and the preparation of a first embodiment of the closure device for delivery. -
FIGS. 12-15 are schematic views illustrating the delivery of the first embodiment of the closure device within the atria. -
FIGS. 16 a and 16 b are partial cross-sectional view of a deployment handle accompanied by a perspective view of the hinge mechanism of the first wing during deployment of the wings. -
FIGS. 17-19 are schematic views illustrating the deployment of the first embodiment of the closure device within the atria. -
FIGS. 20 a-20 c are detailed perspective views illustrating the hinge mechanism of the first wing during deployment of the wings of the first embodiment of the closure device. - For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments, or examples, illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
- The present invention relates to a system and method for closing overlapping layers of tissue in a human or animal body. The various figures show embodiments of a closure device and methods of assembling and using the device to close a patent foramen ovale (“PFO”) in a patient's heart. One of ordinary skill in the art, however, would understand that similar embodiments could be used to close other passageways and openings in the body without departing from the general intent or teachings of the present invention.
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FIG. 1 illustrates aclosure device 10 according to an exemplary embodiment of the present invention for closing a PFO. Theclosure device 10 includes a pair ofwings arms wing 12 is connected to thearm 16 via ahinge mechanism 20, and thewing 14 is connected to thearm 18 via ahinge mechanism 22. - The
wings sheets wings wings sheets wings - In the pictured embodiment in
FIG. 1 , thewings wings wings frames sheets -
FIG. 2 illustrates thearm 16 and thearm 18 being of substantially identical size and shape. In this embodiment, thearm 16 is shaped like an oblong paddle having arounded end 32 and arounded end 34. Thearm 16 includes abody portion 36 integrally and rigidly connected to atab portion 38. Thearm 16 includes anupper surface 39. In some embodiments, thebody portion 36 and thetab portion 38 may share a continuous upper surface. Thebody portion 36 includes anaperture 40 extending from theupper surface 39 through the body portion and includes apassage 41 extending longitudinally through the body portion from anopening 37 to theaperture 40. Thebody portion 36 is generally thicker than thetab portion 38. In this embodiment, theaperture 40 is generally circular and sized for a portion of thehinge mechanism 20 to operate therein. In other embodiments, the aperture may have other shapes such as a square or an oval. - The
arm 18 is also shaped like an oblong paddle and includes arounded end 42 and arounded end 44. Thearm 18 includes abody portion 46 integrally and rigidly connected to atab portion 48. Thearm 18 includes alower surface 49. In some embodiments, thebody portion 46 and thetab portion 48 may share a continuous lower surface. Thebody portion 46 includes anaperture 50 extending from thelower surface 49 through the body portion and includes apassage 51 extending longitudinally through the body portion from anopening 47 to theaperture 50. Thebody portion 46 is generally thicker than thetab portion 48. In this embodiment, theaperture 50 is generally circular and sized for a portion of thehinge mechanism 22 to operate therein. In other embodiments, the aperture may have other shapes such as a square or an oval. - The
surfaces arms surfaces arms surfaces arms -
FIG. 3 a shows a detailed view of the central interconnection between thearm 16 and thearm 18. Theopening 37 of thearm 16 receives theend 44 of thearm 18, and thetab 48 slides into thepassage 41. Simultaneously, theopening 47 of thearm 18 receives theend 34 of thearm 16, and thetab 38 slides into thepassage 51. The interconnection of thetabs passages passages tabs arms - In an alternative embodiment, as shown in
FIG. 3 b, thearms 16′ and 18′ are substantially similar toarms arms 16′ and 18′ can be interlocked as described above, but in this embodiment, areleasable locking mechanism 52 further secures thearms 16′, 18′ together. Thelocking mechanism 52 includes a set of mechanical connection structures configured as ridges. The mechanical connection structures comprise a set ofridges 54 extending fromtab 38′ to interlock with a set ofridges 55 extending from the inferior surface of thepassage 51′ and a set ofridges 56 extending fromtab 48′ to interlock with a set ofridges 57 extending from the superior surface ofpassage 41′. Theridges 54 may also interlock with theridges 56. Theridges arms 16′, 18′ sliding apart from each other than is offered to thearms 16′, 18′ sliding toward each other. Nevertheless, the resistance imparted by the locking mechanism may be overcome, by sufficient force, to release the interconnection of thearms 16′, 18′ and allow thearms 16′, 18′ to separate. - It is understood that the configuration of the releasable locking mechanism can include any of a variety of mechanical connection structures of various sizes, dimensions, shapes, and configurations. In addition, each
individual tab 38′, 48′ and eachindividual passage 41′, 51′ may include a variety of mechanical connection structures of various sizes, dimensions, shapes, and configurations. For example, in an alternative embodiment illustrated inFIG. 3 c, the mechanical connection structures on eachtab 38′, 48′ and inside eachpassage 41′, 51′ may comprisehemispheric protrusions 58 and triangular, teeth-like protrusions 59 to offer more resistance to thearms 16′, 18′ sliding apart from each other than is offered to thearms 16′, 18′ sliding toward each other. The resistance imparted by thehemispheric protrusions 58 may be overcome, by sufficient force, to release the interconnection of the arms and allow thearms 16′, 18′ to partially separate. Thetriangular protrusions 59, however, are shaped, configured, and positioned to prevent thearms 16′, 18′ from completely separating. It is understood that the configuration of the releasable locking mechanism can include any of a variety of mechanical connection structures of various sizes, dimensions, shapes, and configurations. -
FIG. 4 illustrates features of theclosure device 10 that slidably draw thearms wings outer tool 70 is releasably connected to thebody 36 of thearm 16. Theouter tool 70 is shaped as a hollow, cylindrical tube having a proximal end 72 (not shown) and a threadeddistal end 74. A threadedrecess 76 is formed in theend 32 of thearm 16. Theouter tool 70 is releasably connected to thearm end 32 by threaded engagement of the threadeddistal end 74 of the outer tool in the threadedrecess 76. In alternative embodiments, other connectors such as clamps, magnets, or spring-biased connectors may be used to connect the outer tool to thearm 16. - In
FIG. 4 , aninner tool 80 is shown releasably connected to theend 44 of thearm 18. Theinner tool 80 is configured as an elongate structure having a proximal end 82 (not shown) and a threadeddistal end 84. In various embodiments, the inner tool can be configured as a cable, a wire, or a rod, for example. A threadedrecess 86 is formed in theend 44 of thearm 18. Theinner tool 80 is releasably connected to thearm end 44 by threaded engagement of the threadeddistal end 84 of the inner tool in the threadedrecess 86. In alternative embodiments, other connectors such as clamps, magnets, or spring-biased connectors may be used to connect the inner tool to thearm 18. Theinner tool 80 is configured to be slidably received within theouter tool 70. As will be explained in further detail below, moving theinner tool 80 within and relative to theouter tool 70 causes thetab 48 to slide within thepassage 41 and thetab 38 to slide within thepassage 51. -
FIG. 4 also illustrates thehinge mechanism 20 attached to thearm 16. Thehinge mechanism 20 includes two hinge pins 90 and twohinge tips 92. The two hinge pins 90 are straight, rod-like structures extending through thebody 36 and into theaperture 40 of thearm 16 along alongitudinal axis 94. One end of eachhinge pin 90 is connected, either integrally or by a mechanical connector, to thesupport frame 28 of thewing 12, and the opposite end of each hinge pin extends into theaperture 40. Eachhinge tip 92 is a projection shaped as a curved rod extending from eachhinge pin 90 in a plane transverse or oblique to theaxis 94. - The
wing 12 is pivotally connected to thearm 16 and rotates around theaxis 94 via thehinge mechanism 20. As the physician exerts a pulling force on theproximal end 82 of theinner tool 80, thetab 48 of thearm 18 slides within thepassage 41 of thearm 16 in the direction of the pulling force. As thetab 48 slides into thepassage 41, thetab 38 of thearm 16 simultaneously slides within thepassage 51 of thearm 18, causing thearms hinge tips 92 are curved such that when thetab 48 is pulled by theinner tool 80 towards theend 32 of thearm 16, thetab 48 extends into theaperture 40 and contacts convex portions of thecurved hinge tips 92 to swivel thehinge tips 92 about theaxis 94, thereby causing the hinge pins 90 to rotate about theaxis 94. The rotation of the hinge pins 90 causes the simultaneous rotation of thewing 12 toward thearm 16. - The
hinge mechanism 22, as shown inFIG. 1 , is configured to be substantially identical to thehinge mechanism 20. Thehinge mechanism 22 includes two hinge pins and two hinge tips that are substantially identical in both structure and function to the hinge pins 90 and thehinge tips 92. Thewing 18 is pivotally connected to thearm 16 via thehinge mechanism 22. When theinner tool 80 is pulled and moved relative to theouter tool 70, thetab 38 of thearm 16 slides within thepassage 51 of thearm 18 in the direction opposite of the pulling force. The advancingend 34 of thetab 38 extends into theaperture 50 and contacts convex portions of the curved hinge tips of thehinge mechanism 22 to swivel the hinge tips and thereby cause the hinge pins to rotate. The rotation ofhinge mechanism 22 causes the simultaneous rotation of thewing 14 toward thearm 18. - In order to introduce the
closure device 10 into the atrial chambers through a minimally invasive, percutaneous procedure, the physician first compresses theclosure device 10 into a configuration that is sized to pass within a standard intraluminal delivery catheter.FIG. 5 illustrates a dumbbell-shapedcompression apparatus 102 designed to compress theclosure device 10 into a configuration that is sized for containment within anassembly sheath 104. Thecompression apparatus 102 includes aproximal tube 106, aproximal container 108, a connectingtube 110, adistal container 112, and a distalflush port 114. Theassembly sheath 104 is an elongate, cylindrical, hollow tube having a proximal end (not shown) and adistal end 116. Theassembly sheath 104 is sized and configured to receive and contain theclosure device 10 in a compressed state. The diameter of theassembly sheath 104 is sized such that the assembly sheath can flushly slide within theproximal tube 106, but cannot advance into the connectingtube 110. Thedistal end 116 of theassembly sheath 104 is removably and slidably engagable with theproximal tube 106. Theassembly sheath 104 possesses sufficient flexibility to flushly slide inside theproximal tube 106, but also possesses sufficient axial stiffness to maintain theclosure device 10 in a compressed state and to easily advance into a delivery sheath. - The
proximal container 108 and thedistal container 112 are configured to be substantially identical in size and shape. In the embodiment pictured inFIG. 5 , thecontainers containers closure device 10 in an expanded state. Thesecontainers upper walls lower walls upper walls lower walls upper walls closure device 10. Thecontainers proximal surfaces distal surface - The
containers tube 110, a rigid, cylindrical, hollow tube. The connectingtube 110 is sized and configured to slidably receive theclosure device 10 in a compressed state. The connectingtube 110 extends perpendicularly between thedistal surface 124 a of the proximal container and theproximal surface 122 b of the distal container, such that the lumens of thecontainers tube 110 are centrally aligned and contiguous. The connectingtube 110 comprises a transparent hemi-cylindricalupper portion 126 and an opaque hemi-cylindricallower portion 128 that are integrally connected to the transparent upper walls 118 and the opaque lower walls 120, respectively. - The
proximal tube 106 is a rigid, cylindrical, hollow tube extending perpendicularly from theproximal surface 122 a of theproximal container 108 such that theproximal tube 106 is coaxial with the connectingtube 110. Theproximal tube 106 comprises a transparent hemi-cylindricalupper portion 129 and an opaque hemi-cylindricallower portion 130 that are integrally connected to theupper wall 118 a and to thelower wall 120 a, respectively. It is understood that in alternative embodiments, any of the components described as opaque may be transparent or portions of components described as transparent may be opaque. The lumens of theproximal tube 106, theproximal container 108, the connectingtube 110, and thedistal container 112 are centrally aligned and contiguous. Theproximal tube 106 is sized and configured to slidably receive and introduce thedistal end 116 of theassembly sheath 104 into the lumen of theproximal container 108. - The distal
flush port 114 is a rigid, cylindrical hollow tube extending from thedistal surface 124 b of thedistal container 112 into the lumen of thedistal container 112 such that the distalflush port 114 is coaxial with the connectingtube 110 and theproximal tube 106. The distalflush port 114 comprises a transparent hemi-cylindricalupper portion 115 a and an opaque hemi-cylindricallower portion 115 b that are integrally connected to theupper wall 118 b and to thelower wall 120 b, respectively. - To begin the compression process, the physician first detaches or hingedly separates the
upper components lower components closure device 10 into thecompression apparatus 102 such that thearms tube 110 and thewings containers wing 12 is positioned within theproximal container 108 and thewing 14 is positioned within thedistal container 112. Within the connectingtube 110, thearms tab 48 extends at least partially within thepassage 41 and thetab 38 extends at least partially within thepassage 51. Theouter tool 70 and theinner tool 80 may be connected to thearm 16 and thearm 18, respectively, in the manner described above. It is understood that this connection of the tools to the arms may be performed either before or while theclosure device 10 is positioned in thecompression apparatus 102. The outer andinner tools proximal tube 106, and theassembly sheath 104 is advanced over the outer andinner tools - Next, the physician reattaches the
upper components lower components compression apparatus 102. The interior of thecompression apparatus 102 is flushed with saline through the distalflush port 114. - As
FIG. 6 illustrates, the compression process proceeds by advancing theouter tool 70 and thus thewhole closure device 10 toward the distalflush port 114. Thewing 12 is forced to deform into a compressed state as it enters the connectingtube 110 while thewing 14 swings freely in thedistal container 112. Theassembly sheath 104 is then advanced toward the connectingtube 110 until the assembly sheath abuts the connectingtube 110 within theproximal container 108. - As shown in
FIG. 7 , when theouter tool 70 is retracted, thewing 12 is drawn from the connectingtube 110 into theassembly sheath 104. Thefirst wing 12 maintains its compressed state as it is drawn into theassembly sheath 104. - As shown in
FIG. 8 , theouter tool 70 is further proximally retracted, thearms tube 110 into theassembly sheath 104 and thewing 14 is deformed into a compressed shape as it passes through the connectingtube 110. Thewing 14 maintains its compressed state as it is drawn into theassembly sheath 104. -
FIG. 9 illustrates theentire closure device 10 positioned inside theassembly sheath 104 with bothwings -
FIG. 10 illustrates theassembly sheath 104 separated from thecompression apparatus 102. Theassembly sheath 104 contains theclosure device 10 in a compressed state. -
FIGS. 11 a-11 i illustrate an alternative embodiment of a compression apparatus and the preparation of the first embodiment of the closure device for delivery. In this embodiment, thecompression apparatus 140 includes aproximal tube 142, a connectingbar 144, and adistal tube 146. The diameter of theassembly sheath 104 is sized such that theassembly sheath 104 can flushly slide within theproximal tube 142, but cannot advance into thedistal tube 146. Thedistal end 116 of theassembly sheath 104 is removably and slidably engagable with theproximal tube 142. Theassembly sheath 104 possesses sufficient flexibility to flushly slide inside theproximal tube 142 such that the lumen of theassembly sheath 104 is coaxial with the lumen of theproximal tube 142, but also possesses sufficient axial stiffness to maintain theclosure device 10 in a compressed state and to easily advance into a delivery sheath. - In the embodiment pictured in
FIGS. 11 a-11 i, theproximal tube 142 and thedistal tube 146 are configured as rigid, hollow, cylindrical tubes. Thedistal tube 146 is sized to have a length substantially similar to the length of thearms arm 16 is connected to thearm 18. Theproximal tube 142 can have a shorter length than the length of thedistal tube 146. Theproximal tube 142 comprises a transparent hemi-cylindricalupper portion 148 a and an opaque hemi-cylindricallower portion 150 a. Thedistal tube 146 comprises a transparent hemi-cylindricalupper portion 148 b and an opaque hemi-cylindricallower portion 150 b. The transparentupper portions lower portions upper portions closure device 10. - The
proximal tube 142 and thedistal tube 146 are connected by the connectingbar 144, a rigid, elongate bar. The connectingbar 144 is sized to hold both theproximal tube 142 and thedistal tube 146 at a distance apart from each other. The opaquelower portions proximal tube 142 anddistal tube 146, respectively, are fixedly attached to the connectingbar 144 such that theproximal tube 142 is spaced a distance apart from thedistal tube 146 and such that the lumens of theproximal tube 142 and thedistal tube 146 are co-axial. The lumens of theassembly sheath 104, theproximal tube 142, and thedistal tube 146 are all co-axial. - To begin the compression process, the physician first detaches the transparent hemi-cylindrical
upper portions tubes lower portions tubes 142. 146, respectively. As shown inFIG. 11 b, the physician then places theclosure device 10 into thecompression apparatus 140 such that thearms distal tube 146 and the wings swing freely. Specifically, thewing 12 is positioned within the space between theproximal tube 142 and thedistal tube 146, and thewing 14 is positioned distal to thedistal tube 146. Theouter tool 70 and theinner tool 80 may be connected to thearm 16 and thearm 18, respectively in the manner described above. It is understood that this connection of the tools to the arms may be performed either before or while theclosure device 10 is positioned in thecompression apparatus 140. Next, as shown inFIG. 11 c, the physician reattaches thetransparent components compression apparatus 140 to theopaque components compression apparatus 140. - As
FIG. 11 d illustrates, when the physician advances theouter tool 70 toward thedistal tube 146, theouter tool 70 simultaneously advances thewing 12 within thedistal tube 146. As thewing 12 advances into thedistal tube 146, thewing 12 is forced to deform into a compressed state as it enters thedistal tube 146 while thewing 14 swings freely distal to thedistal tube 146.FIG. 11 e shows that theassembly sheath 104 is then advanced through theproximal tube 142 and toward thedistal tube 146 until theassembly sheath 104 abuts thedistal tube 146. - As shown by
FIG. 11 f, when the physician proximally retracts theouter tool 70, thewing 12 is drawn from thedistal tube 146 into theassembly sheath 104 as thearms distal tube 146. Thewing 12 maintains its compressed state as it is drawn into theassembly sheath 104.FIG. 11 g illustrates that as theouter tool 70 is further proximally retracted, thearms distal tube 146 into theassembly sheath 104 and thewing 14 is forced to deform into a compressed shape as it passes through thedistal tube 146. Thewing 14 maintains its compressed state as it is drawn into theassembly sheath 104. -
FIG. 11 h illustrates theentire closure device 10 positioned inside theassembly sheath 104 with bothwings distal tube 146. -
FIG. 11 i illustrates theassembly sheath 104 separated from thecompression apparatus 140. Theassembly sheath 104 contains theclosure device 10 in a compressed state. - With the
closure device 10 compressed within theassembly sheath 104 using any of the compression methods described above or known in the art, it is configured for placement within a heart.FIG. 12 shows the two upper chambers in a human heart, theright atrium 152 and theleft atrium 154, separated by an interatrial septum containing aPFO track 156. The interatrial septum includes aseptum primum 158 and aseptum secundum 160. Though the anatomy of PFOs varies widely within the population, the septum primum 158 often extends to and overlaps with theseptum secundum 160 as shown inFIG. 12 . When a PFO is present, blood may travel through thePFO track 156 between the septum primum 158 and theseptum secundum 160. - The
closure device 10 is introduced into theatria closure device 10 may be delivered to the atria via percutaneous methods using a delivery catheter. First, a peripheral vein, such as a femoral vein, is punctured with a needle. A wire is inserted through the needle into the vein, and the needle is removed. A dilator and an introducer sheath with at least one hemostatic valve is inserted through the puncture wound, the wire and the dilator are removed, and the sheath is secured in place while maintaining relative hemostasis. With the introducer sheath in place, a catheter containing a guidewire is introduced through the hemostatic valve of the introducer sheath and advanced along the peripheral vein, into the region of theinferior vena cava 151 and theright atrium 152, and into theleft atrium 154 through thePFO track 156. The catheter is withdrawn while the guidewire is maintained in place. Adelivery sheath 162 and a second dilator are simultaneously introduced into the introducer sheath and advanced over the guidewire to extend from theright atrium 152 into theleft atrium 154 through thePFO track 156. The second dilator and the guidewire are then withdrawn. It is understood that alternative procedures and methods may be used to place thedelivery sheath 162 into thePFO track 156, between septum primum 158 and aseptum secundum 160. -
FIG. 13 illustrates thedelivery sheath 162, containing theclosure device 10, positioned within thePFO track 156 between the septum primum 158 andseptum secundum 160. Thedelivery sheath 162 is an elongate hollow tube with a proximal end 164 and adistal end 166. Thedistal end 166 of thedelivery sheath 162 is positioned within theleft atrium 154. Thedelivery sheath 162 can be a standard delivery sheath as is known in the art or a variation thereof, provided that thedelivery sheath 162 is sized to slidably accommodate theclosure device 10 in a compressed configuration. Thedelivery sheath 162 can be constructed of a radiopaque material or carry radiopaque markers. Theassembly sheath 104, containing theclosure device 10 in a compressed state, is connected to or aligned adjacent to the proximal end 164 of thedelivery sheath 162. Thecompressed closure device 10 is passed through theassembly sheath 104 into thedelivery sheath 162 such that thewing 14 of theclosure device 10 enters thedelivery sheath 162 before thewing 12 of theclosure device 10. Theclosure device 10 is then advanced, still in the compressed configuration, toward thedistal end 166 of thedelivery sheath 162 until thewing 14 is seated within thedistal end 166 of thedelivery sheath 162, as shown inFIG. 13 . Thewing 14 is housed within the distal end of thedelivery sheath 162 and positioned within theleft atrium 154. Thearms closure device 10 are housed within thedelivery sheath 162 and positioned across the PFO track between the overlappingseptum primum 158 andseptum secundum 160. Thewing 12 is housed within thedelivery sheath 162 and positioned within theright atrium 152. - As illustrated in
FIG. 14 , theclosure device 10 is delivered into the atria by withdrawing thedelivery sheath 162 from the heart while leaving theclosure device 10 in place across thePFO track 156. Thedelivery sheath 162 is withdrawn from theleft atrium 154 into theright atrium 152, and then is withdrawn from the heart entirely. The physician can maintain the position of theclosure device 10 by holding theouter tool 70 steady relative to thedelivery sheath 162 as thedelivery sheath 162 is withdrawn from the heart. As thedelivery sheath 162 is withdrawn and theclosure device 10 is released from thedelivery sheath 162, thewings - Thus, as shown in
FIG. 15 , thewing 14 is delivered within the left atrium, thearms wing 12 is delivered within the right atrium. The operator then rotates theouter tool 70 to rotate theclosure device 10 such that the surfaces of thewings septum secundum 160, as shown inFIG. 17 . -
FIGS. 16 a and 16 b depict the physical mechanism by which the physician deploys theclosure device 10. Deployment of theclosure device 10 is directed by maneuvering theinner tool 80 within theouter tool 70. The physician controls the movements of theouter tool 70 and theinner tool 80 by using adeployment handle 170. As shown inFIG. 16 a, thedeployment handle 170 has aproximal end 172 and adistal end 174. Theproximal end 72 of theouter tool 70 is fixedly attached to thedistal end 174 of thedeployment handle 170. The deployment handle 170 includes adeployment lever 176. Theproximal end 82 of theinner tool 80 is fixedly attached to aswivel hinge 178 within thedeployment lever 176. - As shown in
FIG. 16 b, when the physician pulls thedeployment lever 176 towards theproximal end 172 of thedeployment handle 170, theswivel hinge 178 rotates toward theproximal end 172, thereby pulling theinner tool 80 further inside thedeployment handle 170 and causing thetab 48 of thearm 18 to slide within thepassage 41 of thearm 16 toward thehinge mechanism 20. - As shown in
FIG. 20 a, when thetab 48 is pulled by theinner tool 80 towards thehinge mechanism 20, thetab 48 contacts the convex portions of thehinge tips 92 and swivels thehinge tips 92 within theaperture 40 of thearm 16, causing the hinge pins 90 to rotate. As shown inFIGS. 17 and 20 b, the rotation of the hinge pins 90 causes the simultaneous rotation of thewing 12 toward thearm 16. As thetab 48 slides into thepassage 41, thearms tab 38 of thearm 16 to simultaneously slide within thepassage 51 of thearm 18 toward the hinge mechanism 22 (not shown). When thetab 38 of thearm 16 contacts the convex portions of the hinge tips of thehinge mechanism 22, the hinge tips swivel within theaperture 50 of thearm 18 and cause the hinge pins to rotate. The rotation of the hinge pins of thehinge mechanism 22 causes the simultaneous rotation of thewing 14 toward thearm 18, as shown inFIGS. 17 and 18 . - Further retraction of the
inner tool 80 causes the tabs to further rotate the hinge tips. As shown inFIG. 19 and partially shown inFIG. 20 c, when thetabs passages wing 12 swivels upward to press against theseptum secundum 160 and thewing 14 swivels downward to press against theseptum primum 158. In addition, when thetabs passages arms wing 12 against theseptum secundum 160 and thewing 14 against theseptum primum 158. It should be noted that theseptum secundum 160 and the septum primum 158 do not have to be tightly touching along their entire lengths to effect proper closure of the PFO. Instead, it may be sufficient that theseptum secundum 160 and theseptum primum 158 are only brought close enough to allow tissue ingrowth to eventually seal the defect. - The physician may visually assess the delivery and deployment of the closure device by various methods including fluoroscopy, ultrasonography, and magnetic resonance imaging. For example, fluoro-visible dyes, such as radiopaque contrast, may be injected into the venous circulation and atria such that the venous vasculature and atrial chambers are visible using a fluoroscopic imaging device. Such a procedure, known as a type of venogram, allows the physician to localize a desired target location and to guide proper device positioning while performing the implantation procedure. In addition, an ultrasonic probe may be positioned in the patient's esophagus, within the patient's chest cavity, or on the patient's chest to image the heart. Moreover, the individual components of the
closure device 10 and thedelivery sheath 162 can include radiopaque fillers or markers that permit the physician to fluoroscopically visualize their location and orientation within the patient. Such radiopaque markers or fillers may be fabricated from noble metals such as platinum and gold, and may be attached to theclosure device 10 using a variety of known methods such as adhesive bonding, lamination between two layers of polymers, or vapor deposition, for example. - After deploying the
closure device 10 across the PFO track, the physician can reposition theclosure device 10 by rotating, retracting, or advancing theouter tool 70 by rotating, retracting, or advancing the deployment handle 170 itself. After final positioning of theclosure device 10, theinner tool 80 is disconnected from theclosure device 10 by reverse threading thedistal end 84 from thearm 18, theouter tool 70 is disconnected from theclosure device 10 by reverse threading thedistal end 74 from thearm 16, and both theinner tool 80 and theouter tool 70 are removed from the heart. - In some instances it may be necessary for the physician to remove the
closure device 10 from the heart. For example, the physician may need to remove theclosure device 10 from the heart if theclosure device 10 is not appropriately sized for theparticular PFO track 156 and/or if theclosure device 10 cannot adequately seal thePFO track 156. The physician may use a suitable foreign body retrieval device, as is known in the art, to remove theclosure device 10 from the heart. In some embodiments, thearm 16 has a retrieval formation such as a hook-like protrusion 96, as shown inFIG. 4 , disposed on thebody 36 at theend 32. The physician can retrieve theclosure device 10 by using the foreign body retrieval device to snare or hook thearm 16 at theprotrusion 96 and pull thearm 16 into a retrieval sheath. Pulling thearm 16 into the retrieval sheath will partially separate thearm 16 from thearm 18, thereby disengaging the lockedhinge mechanisms wings atria closure device 10 completely into retrieval sheath. As the physician retracts thewings wings entire closure device 10 from the patient's body. - In one exemplary aspect, the present disclosure is directed to a system for closing a patent foramen ovale (PFO) in a heart. The system may comprise a delivery catheter, a closure device, an outer tool, and an inner tool. The delivery catheter may have a lumen extending along a longitudinal axis. The closure device may be configured for delivery into the heart and for collapsible containment within the lumen. The closure device may comprise a first arm, a second arm, a first wing, and a second wing. The first arm may include a first body portion and a first tab portion, wherein the first body portion may include a first passage extending longitudinally therethrough. The second arm may include a second body portion and a second tab portion, wherein the second body portion may include a second passage extending longitudinally therethrough. The second passage may be sized to slidably receive the first tab portion and the first passage may be sized to slidably receive the second tab portion. The first wing may be pivotally connected to the first arm and the second wing may be pivotally connected to the second arm. The outer tool may be configured for attachment to the first body portion and have a lumen extending longitudinally through its length. The inner tool may be configured for attachment to the second tab portion. The lumen of the outer tool may be sized to receive a portion of the inner tool, wherein the inner tool is movable with respect to the outer tool to slide the second tab portion with respect to the first passage.
- In another exemplary aspect, the present disclosure is directed to a system for closing a patent foramen ovale (PFO) in a heart. The system may comprise a delivery catheter, a closure device, an outer tool, and an inner tool. The delivery catheter may have a lumen extending along a longitudinal axis. The closure device may be configured for delivery into the heart and for collapsible containment within the lumen. The closure device may comprise a first arm and a second arm. The first arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a first wing via a first hinge and the first hinge includes a first projection. The second arm may include proximal and distal ends, wherein the proximal end is pivotally connected to a second wing via a second hinge and the second hinge includes a second projection. The distal end of the first arm may be configured to engage the second projection to pivot the second wing with respect to the second arm, and the distal end of the second arm may be configured to engage the first projection to pivot the first wing with respect to the first arm. The outer tool may be configured for attachment to the proximal end of the first arm and have a lumen extending longitudinally through its length. The inner tool may be configured for attachment to the distal end of the second arm. The lumen of the outer tool may be sized to receive a portion of the inner tool, wherein the inner tool is movable with respect to the outer tool to slide the distal end of the second arm with respect to the first hinge.
- The devices, systems, and methods described herein provide an improved and more efficient system of PFO closure. Applicants note that the procedures disclosed herein are merely exemplary and that the services and methods disclosed herein may be utilized for numerous other medical processes and procedures. Although several selected embodiments have been illustrated and described in detail, it will be understood that they are exemplary, and that a variety of substitutions and alterations are possible without departing from the spirit and scope of the present invention, as defined by the following claims.
Claims (21)
1.-25. (canceled)
26. A method for closing a patent foramen ovale (PFO) in a heart, the PFO comprising a lumen between a septum primum and a septum secundum, the method comprising the steps of:
providing a closure device comprising a first wing, a first arm, a second arm, and a second wing;
providing an assembly sheath having a lumen extending longitudinally through its length, the lumen sized and configured to contain the closure device in a collapsed configuration;
providing a delivery catheter having a lumen extending longitudinally through its length, the lumen sized and configured to contain the assembly sheath;
inserting the closure device into the lumen of the assembly sheath such that the closure device is in a collapsed configuration;
advancing the delivery catheter into a desired location within the heart;
connecting the assembly sheath to the delivery catheter;
advancing the closure device through the assembly sheath into the delivery sheath;
delivering the closure device at least partially within the PFO;
withdrawing the delivery catheter such that the first arm and the second arm are positioned within the lumen of the PFO, the second wing is positioned in a left atrium of the heart, and the first wing is positioned in a right atrium of the heart;
rotating the closure device such that the first wing and the second wing are about parallel to the septum secundum and the septum primum, respectively; and
interlocking the first arm and second arm such that the second wing is positioned against the septum primum and the first wing is positioned against the septum secundum, wherein the first wing and the second wing exert force on the septum secundum and septum primum, respectively, to push overlapping layers of the septum secundum and the septum primum together to close the PFO.
27. The method of claim 26 wherein positioning the second wing in a left atrium of the heart includes withdrawing the delivery catheter such that the second wing self-expands into a predetermined shape, and positioning the first wing in a right atrium of the heart includes withdrawing the delivery catheter such that the first wing self-expands into a predetermined shape.
28. The method of claim 27 wherein the predetermined shape is an ellipse.
29. The method of claim 26 wherein inserting the closure device into the lumen of the assembly sheath comprises: positioning the first wing in a first container of a compression device; positioning the second wing in a second container of the compression device; positioning the first and second arms in a connecting member of the compression device; inserting the assembly sheath into the compression device such that the assembly sheath extends at least partially into the first container of the compression device; and compressing the first and second wings into the assembly sheath.
30. The method of claim 29 further including the step of flushing the first container, the second container, and the connecting tube with liquid prior to compressing the first wing.
31. The method of claim 26 wherein inserting the closure device into the lumen of the assembly sheath comprises: positioning the first wing between a first tube and a second tube of a compression device; positioning the second wing distal to the second tube of the compression device; positioning the first and second arms in the second tube of the compression device; inserting the assembly sheath into the compression device such that the assembly sheath extends at least partially into the first tube of the compression device; and compressing the first and second wings into the assembly sheath.
32. A method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum, the method comprising:
providing a first closure component including a first body portion connected between a first tab and a first wing, the first body portion including a first passage extending longitudinally therethrough;
providing a second closure component including a second body portion connected between a second tab and a second wing, the second body portion including a second passage extending longitudinally therethrough;
positioning the first and second body and tab portions into the patent foramen ovale;
sliding the second tab portion within the first passage;
sliding the first tab portion within the second passage;
engaging the septum primum between the first and second body portions and the first wing; and
engaging the septum secundum between the first and second body portions and the second wing.
33. A method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum, the method comprising:
providing a first arm with proximal and distal ends, the proximal end pivotally connected to a first wing via a first hinge, the first hinge including a first projection;
providing a second arm with proximal and distal ends, the proximal end pivotally connected to a second wing via a second hinge, the second hinge including a second projection;
engaging the distal end of the first arm with the second projection to rotate the second wing with respect to the second arm; and
engaging the distal end of the second arm with the first projection to rotate the first wing with respect to the first arm.
34. The method of claim 32 , further including rotating the first and second body and tab portions within the patent foramen ovale until the first wing and the second wing are substantially parallel to the septum primum and the septum secundum, respectively.
35. The method of claim 32 , further including engaging a first hinge portion disposed on the first body portion with the second tab.
36. The method of claim 35 , wherein engaging the septum primum between the first and second body portions and the first wing comprises rotating the first wing about the first hinge element.
37. The method of claim 32 , further including engaging a second hinge portion disposed on the second body portion with the first tab.
38. The method of claim 37 , wherein engaging the septum secundum between the first and second body portions and the second wing comprises rotating the second wing about the second hinge element.
39. The method of claim 32 , wherein sliding the second tab portion within the first passage and sliding the first tab portion within the second passage includes expanding the first wing and second wing, respectively, into a pre-determined shape.
40. The method of claim 32 , further including interlocking the first tab portion and the second tab portion such that the first wing and the second wing are secured in place about the PFO.
41. The method of claim 33 , wherein engaging the distal end of the first arm with the second projection comprises rotating the second projection toward the proximal end of the second arm.
42. The method of claim 33 , wherein engaging the distal end of the second arm with the first projection comprises rotating the first projection toward the proximal end of the first arm.
43. The method of claim 33 , further including sliding the distal end of the first arm into a first passage extending longitudinally within a proximal portion of the second arm, and sliding the distal end of the second arm into a second passage extending longitudinally within a proximal portion of the first arm.
44. The method of claim 43 , further including securing the distal end of the first arm within the passage of the second arm, and securing the distal end of the second arm within the passage of the first arm.
45. The method of claim 33 , further including interlocking the distal end of the first arm with the distal end of the second arm.
Priority Applications (1)
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US14/067,255 US20140052174A1 (en) | 2011-04-28 | 2013-10-30 | Devices and methods for closure of a patent foramen ovale |
Applications Claiming Priority (2)
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US13/096,081 US8591543B2 (en) | 2011-04-28 | 2011-04-28 | Devices and methods for closure of a patent foramen ovale |
US14/067,255 US20140052174A1 (en) | 2011-04-28 | 2013-10-30 | Devices and methods for closure of a patent foramen ovale |
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US13/096,081 Division US8591543B2 (en) | 2011-04-28 | 2011-04-28 | Devices and methods for closure of a patent foramen ovale |
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US10307167B2 (en) | 2012-12-14 | 2019-06-04 | Corquest Medical, Inc. | Assembly and method for left atrial appendage occlusion |
US10314594B2 (en) | 2012-12-14 | 2019-06-11 | Corquest Medical, Inc. | Assembly and method for left atrial appendage occlusion |
US10813630B2 (en) | 2011-08-09 | 2020-10-27 | Corquest Medical, Inc. | Closure system for atrial wall |
US20140142689A1 (en) | 2012-11-21 | 2014-05-22 | Didier De Canniere | Device and method of treating heart valve malfunction |
US9724082B2 (en) * | 2013-03-15 | 2017-08-08 | Cook Medical Technologies Llc | Delivery system for tissue opening closures |
US9566443B2 (en) | 2013-11-26 | 2017-02-14 | Corquest Medical, Inc. | System for treating heart valve malfunction including mitral regurgitation |
US10842626B2 (en) | 2014-12-09 | 2020-11-24 | Didier De Canniere | Intracardiac device to correct mitral regurgitation |
CN106923885B (en) * | 2015-12-31 | 2019-07-09 | 先健科技(深圳)有限公司 | Occluder for left auricle |
IT201800020707A1 (en) * | 2018-12-21 | 2020-06-21 | Eustaquio Maria Onorato | Patent foramen ovale occlusion device. |
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US20070198038A1 (en) * | 2001-12-03 | 2007-08-23 | Cohen Adam L | Microdevices for Tissue Approximation and Retention, Methods for Using, and Methods for Making |
US20110092988A1 (en) | 2002-10-29 | 2011-04-21 | Microfabrica Inc. | Microdevices for Tissue Approximation and Retention, Methods for Using, and Methods for Making |
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WO2005110240A1 (en) * | 2004-05-07 | 2005-11-24 | Nmt Medical, Inc. | Catching mechanisms for tubular septal occluder |
JP4418785B2 (en) | 2004-09-29 | 2010-02-24 | テルモ株式会社 | Patent application for patent foramen ovale and instrument for patent foramen ovale |
US20060241687A1 (en) * | 2005-03-16 | 2006-10-26 | Glaser Erik N | Septal occluder with pivot arms and articulating joints |
WO2006130836A2 (en) | 2005-06-02 | 2006-12-07 | Cordis Corporation | Patent foramen ovale closure device |
US8162974B2 (en) | 2006-02-02 | 2012-04-24 | Boston Scientific Scimed, Inc. | Occlusion apparatus, system, and method |
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2011
- 2011-04-28 US US13/096,081 patent/US8591543B2/en active Active
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2012
- 2012-04-13 WO PCT/US2012/033420 patent/WO2012148696A1/en active Application Filing
- 2012-04-13 EP EP12715534.9A patent/EP2701609A1/en not_active Withdrawn
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2013
- 2013-10-30 US US14/067,255 patent/US20140052174A1/en not_active Abandoned
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US5108420A (en) * | 1991-02-01 | 1992-04-28 | Temple University | Aperture occlusion device |
US7867250B2 (en) * | 2001-12-19 | 2011-01-11 | Nmt Medical, Inc. | Septal occluder and associated methods |
US8029532B2 (en) * | 2006-10-11 | 2011-10-04 | Cook Medical Technologies Llc | Closure device with biomaterial patches |
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WO2012148696A1 (en) | 2012-11-01 |
EP2701609A1 (en) | 2014-03-05 |
US8591543B2 (en) | 2013-11-26 |
US20120277791A1 (en) | 2012-11-01 |
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Owner name: CARDIOTULIP LLC, TEXAS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ABO-AUDA, WAEL;ABUGHAZALEH, WALEED;SIGNING DATES FROM 20110425 TO 20110426;REEL/FRAME:031706/0636 |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |