Patent foramen ovale closure device

A device for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The deployment device has a first tubular structure having proximal and distal ends. A second tubular structure is substantially coaxial to and slideably engaged within the first tubular structure. The second tubular structure has a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure. A third tubular structure is substantially coaxial to and slideably engaged within the second tubular structure. The third tubular structure is configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.

FIELD OF THE INVENTION

This invention relates to devices for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway.

BACKGROUND OF THE INVENTION

Patent foramen ovale (PFO) is an anatomical interatrial communication with potential for right-to-left shunting of blood. Foramen ovale has been known since the time of Galen. In 1564, Leonardi Botali, an Italian surgeon, was the first to describe the presence of foramen ovale at birth. However, the function of foramen ovale in utero was not known at that time. In 1877, Cohnheim described paradoxical embolism in relation to patent foramen ovale.

Patent foramen ovale is a flap-like opening between the atrial septa primum and secundum at the location of the fossa ovalis that persists after age one year. 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 (SP) against the walls of the septum secundum (SS), 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 (SP) to the septum secundum (SS).

Where anatomical closure of the foramen ovale does not occur, a patent foramen ovale (PFO) is created. A patent foramen ovale is a persistent, usually flap-like opening between the atrial septum primum (SP) and septum secundum (SS) of a heart. A patent foramen ovale results when either partial or no fusion of the septum primum (SP) to the septum secundum (SS) occurs. In the case of partial fusion or no fusion, a persistent passageway (PFO track) exists between the septum primum (SP) and septum secundum (SS). This opening or passageway is typically parallel to the plane of the septum primum, and has a mouth that is generally oval in shape. Normally the opening is relatively long, but quite narrow. The opening may be held closed due to the mean pressure in the left atrium (LA) being typically higher than in the right atrium (RA). In this manner, the septum primum acts like a one-way valve, preventing fluid communication between the right and left atria through the PFO track. However, at times, the pressure may temporarily be higher in the right atrium, causing the PFO track to open up and allow some fluid to pass from the right atrium to the left atrium. 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 (PFO). It is believed that embolism via a PFO may be a cause of a significant number of ischemic strokes, particularly in relatively young patients. It has been estimated that in 50% of cryptogenic strokes, a PFO is present. Blood clots that form in the venous circulation (e.g., the legs) 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 a transient ischemic attack (TIA) in the presence of a PFO often are considered for medical therapy to reduce the risk of a recurrent embolic event.

Pharmacological therapy often includes oral anticoagulants or antiplatelet agents. These therapies may lead to certain side effects, including hemorrhage. If pharmacologic therapy is unsuitable, open heart surgery may be employed to close a PFO with stitches, for example. Like other open surgical treatments, this surgery is highly invasive, risky, requires general anesthesia, and may result in lengthy recuperation.

Nonsurgical closure of a PFO is possible with umbrella-like devices developed for percutaneous closure of atrial septal defects (ASD) (a condition where there is not a well-developed septum primum (SP)). Many of these conventional devices used for ASD, however, are technically complex, bulky, and difficult to deploy in a precise location. In addition, such devices may be difficult or impossible to retrieve and/or reposition should initial positioning not be satisfactory. Moreover, these devices are specially designed for ASD and therefore may not be suitable to close and seal a PFO, particularly because the septum primum (SP) overlaps the septum secundum (SS).

SUMMARY OF THE INVENTION

The present invention relates to a device for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such delivering device. The deployment device has a first tubular structure having proximal and distal ends. A second tubular structure is substantially coaxial to and slideably engaged within the first tubular structure. The second tubular structure has a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure. A third tubular structure is substantially coaxial to and slideably engaged within the second tubular structure. The third tubular structure is configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.

The present invention also related to a method of deploying a mechanical closure device through the septum of a heart to facilitate closing of a patent foramen ovale. The method comprises the steps of accessing the right atrium of the heart with a deployment device carrying the mechanical closure device. The mechanical closure device includes a proximal and distal anchor with a closure line attached there between. The deployment device is then advanced distally until the deployment device penetrates through the interatrial septum into the left atrium. Once in the left atrium, the distal end of the deployment device is oriented back towards the interatrial septum. The deployment device is advanced until the distal end of the deployment device penetrates through the interatrial septum into the right atrium. The distal anchor is deployed from the distal end of the deployment device into the right atrium and the deployment device is retracted back from the right atrium to the left atrium, and then from the left atrium to the right atrium, leaving a portion of the closure line between the proximal and distal anchors in the left atrium. The proximal anchor associated with the mechanical closure device is then deployed from the distal end of the deployment device into the right atrium.

DETAILED DESCRIPTION OF THE INVENTION

The various figures show embodiments of the patent foramen ovale (PFO) closure device and methods of using the device to close a PFO. The device and related methods are described herein in connection with mechanically closing a PFO. These devices, however, also are suitable for closing other openings or passageways, including other such openings in the heart, for example atrial septal defects, ventricular septal defects, and patent ducts arterioses, as well as openings or passageways in other portions of a body such as an arteriovenous fistula. The invention therefore is not limited to use of the inventive closure devices to close PFO's.

A human heart has four chambers. The upper chambers are called the left and right atria, and the lower chambers are called the left and right ventricles. A wall of muscle called the septum separates the left and right atria and the left and right ventricles. That portion of the septum that separates the two upper chambers (the right and left atria) of the heart is termed the atrial (or interatrial) septum while the portion of the septum that lies between the two lower chambers (the right and left ventricles) of the heart is called the ventricular (or interventricular) septum.

FIG. 1illustrates a short-axis view of the heart100at the level of the right atrium (RA) and left atrium (LA), in a plane generally parallel to the atrioventricular groove, and at the level of the aortic valve. This view is looking from caudal to cranial.FIG. 1also shows the septum primum (SP)105, a flap-like structure, which normally covers the foramen ovale115, an opening in the septum secundum (SS)110of the heart100. In utero, the foramen ovale115serves 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 (SP)105against the walls of the septum secundum (SS)110, covering the foramen ovale115and resulting in functional closure of the foramen ovale115. This closure is usually followed by anatomical closure of the foramen ovale115due to fusion of the septum primum (SP)105to the septum secundum (SS)110.

The PFO results when either partial or no fusion of the septum primum105to the septum secundum110occurs. When this condition exists, a passageway (PFO track)120between the septum primum105and septum secundum110may allow communication of blood between the atria. This PFO track120is typically parallel to the plane of the septum primum105, and has an opening that is generally oval in shape.FIG. 2illustrates the opening of the PFO track120as viewed from an end of the track. Normally the opening is relatively tall, but quite narrow. The opening may be held closed by the mean pressure in the left atrium, which is typically higher than the right atrium.FIG. 3is a close-up section view of the PFO track120held in the closed position by left atrial pressure. In this position, the septum primum105acts like a one-way valve, preventing fluid communication between the right and left atria through the PFO track120. Occasionally, the pressure in the right atrium may temporarily be higher than the left atrium. When this condition occurs, the PFO track120opens and allow some fluid to pass from the right atrium to the left atrium, as indicated inFIGS. 4A and 4B. In particular,FIG. 4Ais a cross-sectional view showing the PFO track ofFIG. 2in an open configuration. Similarly,FIG. 4Bis a close-up section view illustrating the PFO track in an open configuration.

Although the PFO track120is often held closed, the endothelialized surfaces of the tissues forming the PFO track120prevent the tissue from healing together and permanently closing the PFO track120. As can be seen inFIGS. 5A-5C, (a view from line “C-C” ofFIG. 1), the septum primum105is firmly attached to the septum secundum110around most of the perimeter of the Fossa Ovalis115, but has an opening along one side. The septum primum105is often connected, as shown, by two or more extensions of tissue along the sides of the PFO track120forming a tunnel.FIG. 5Dis a magnified section view of the PFO track120, showing the tunnel formed by the tissue extensions. Typically, the tunnel length in an adult human can range between 2 and 13 mm.

The present invention relates to a system and method for closing a passageway in a body. In a particular embodiment, the device is used to close the Patent Foramen Ovale in a human heart. One of ordinary skill in the art 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.

FIGS. 6A and 6Billustrate a device used to close the PFO according to one embodiment of the present invention. The device600comprises a flexible closure line625coupled to two expandable anchors620,621. Anchor620is coupled to distal end of the closure line625, while anchor621is coupled to the proximal end of the flexible closure line625. Anchor621is capable of sliding along closure line625and locking in desired location to cinch or take-up slack in closure line625length, bringing the proximal and distal anchors621,620respectively, closer together and effectively bringing the septum secundum110and the septum primum105in close proximation.

It should be noted that the septum secundum110and the septum primum105do not have to be tightly touching to effect proper closure of the PFO. Instead, the septum secundum110and the septum primum105must just be brought close enough to minimize flow from atria to atria (typically flow from left atria to right atria).

The locking mechanism incorporated into anchor621may be a device capable of allowing the closure line625to slide through anchor621in one direction, and prevent sliding movement in the opposite direction. Examples of functionally similar commercial locking mechanisms include the DePuy Mitek RAPIDLOC™ device; zip ties; and similar linear locking devices known in the art.

Alternatively, the anchor621may be fixed to the closure line625at a predetermined distance from anchor620. This may particularly be the case when the closure line625has an elastic or recoil ability and is capable of exerting tension when deployed, pulling the anchors620,621together and effectively compressing the septum primum105to the septum secundum110. In still a further embodiment of the invention, a closure device600may include an elastic closure line625and a slideable anchor621. In this embodiment, the anchor621is capable of allowing the flexible closure line625to slide through the anchor621in one direction, and prevent sliding movement in the opposite direction, while the closure line625exerts tension between the two anchors620,621. These configurations should not necessarily be considered limiting, and other combinations of components are contemplated, such as, for example, both anchors620and621being slideable along a substantially elastic or inelastic closure line625.

The closure line625may be any biocompatible filament known in the art that is capable of securing the septum primum105to the septum secundum110. In a preferred embodiment the closure line625is a surgical suture, such as a multifilament non-biodegradable suture, or a forced entangled fiber filament. Alternatively, the closure line625may be made from an elastic material capable of exerting tension when stretched. In yet another alternative embodiment, the closure line625may be geometrically configured to exhibit structurally elastic behavior. In another alternative embodiment, the closure line625may be made from an anelastic material such as elastomeric polymers that are capable of exerting tension when stretched. In yet another alternative embodiment, the closure line625may be made from a super elastic material such as a nickel titanium alloy.

The anchors620,621are expandable from a first, predeployed unexpanded configuration to a second expanded configuration. The anchors620,621are preferably constructed from a structurally deformable material.

Structurally deformable materials are materials that can elastically or plastically deform without compromising their integrity. Geometric structures, such as anchors620,621, made from a deformable material are capable of changing shape when acted upon by an external force, or removal or an external force.

Geometric structures made from structurally deformable materials are typically self expanding or mechanically expandable. In a preferred embodiment, the anchors620,621are made from a self-expanding material, such as Nitinol or a resilient polymer. However, the self-expanding anchors620,621may also be made from an elastically compressed spring temper biocompatible metals. These self-expanding structures are held in a constrained configuration by an external force, typically a capture sheath, and elastically deform when the constraining force is released.

Some structurally deformable materials may also be mechanically expandable. Geometric structures can be mechanically expanded by introduction of an external force, through, for example, a mechanical expansion means. Mechanical expansion means are well known in the art and include balloon or cage expansion devices.

Once an external mechanical force is introduced to the geometric structure, the structure plastically deforms to its desired final configuration.

The anchors620,621in their constrained state are capable of being held in a restrained low profile geometry for delivery, and assume an expanded shape capable of preventing the anchor620,621from retracting through the septum primum105or septum secundum110, as the case may be, once deployed.

In a preferred embodiment, the anchors620,621are cut from a Nitinol hypotube700by methods known in the art.FIG. 7Ais a perspective view of the anchor620in the cut pre-expanded form.

The anchor620is then formed into a desired expanded configuration and annealed to assume a stress-free (relaxed) state. In one embodiment of the invention, the anchor620,621is formed into a basket shaped configuration, having a plurality of legs710. A perspective view of the expanded basket anchor620according to one embodiment of the present invention is illustrated inFIG. 7B.

Once the closure device600is deployed, the basket shaped anchors620,621collapse under tensioning of the closure line625, into a flattened “flower petal” shape as illustrated inFIG. 7C. In this state, the anchors620,621are under strain. The super elastic properties of the anchors620,621under strain exert an axially outward force against the adjacent tissue, putting the closure line625in tension.

FIG. 8Aillustrates the closure device600having flower petal shaped anchors620,621deployed through the septum secundum and septum primum along the PFO tract to close the PFO according to one embodiment of the present invention. The proximal anchor621inFIG. 8Aalso includes a locking mechanism622integrated therein.

This anchor design should not be considered a limiting feature of the invention, as other shapes and configurations of anchors620,621are also contemplated by the present design. This may include, for example, expandable disc design, star design, j-hook design, or any expandable geometric shape. In addition other materials exhibiting similar characteristics, such as non-biodegradable swellable polymers, are similarly contemplated by the present invention. Still, other designs for anchors620,621may include long-aspect dimensioned objects axially aligned in needles605,610in the constrained state. Once deployed, the long axis of the anchor620,621rotates substantially perpendicular to the needle605,610longitudinal axis, effectively anchoring the closure line625in place.

AlthoughFIG. 8Aillustrates the closure device600deployed through the septum secundum110and septum primum105along the PFO track120, it should be understood that the closure device600may be deployed through other locations to achieve the same results, as illustrated inFIGS. 8B through 8J. For example,FIG. 8Billustrates one leg of the closure device600deployed through both the septum secundum110and septum primum105, while the second leg of the closure device600penetrates only through the septum secundum110.

Similarly,FIG. 8Cillustrates one leg of the closure device600deployed through both the septum secundum110and septum primum105, while the second leg of the closure device600penetrates only through the septum primum105.

FIG. 8Dillustrates one leg of the closure device600penetrating only through the septum secundum110, while the second leg of the closure device600penetrates only through the septum primum105.

FIG. 8Eillustrates each leg of the closure device600penetrating through the septum primum105, but not the septum secundum110. However, the distal anchor620is located to exert pressure against the septum secundum110and septum primum105when the closure device600is tensioned. This pressure forces the septum secundum110and septum primum105into close proximity and facilitates the PFO closure.

Each of the aboveFIGS. 8A through 8Eillustrate the anchors620,621and closure line625in a particular orientation. It should be understood that position of the anchor structures620,621may be reversed.

FIGS. 8A through 8Eillustrate the final position of each anchor device620,621in the right atrial chamber, with the closure line625looping from the right atrial chamber through the left atrial chamber and back into the right atrial chamber. However, it should be understood that the closure device600may be deployed such that the distal anchor620is located in the left atrial chamber, while the proximal anchor621is located in the right atrial chamber.

FIGS. 8F through 8Jillustrate the closure device600deployed at various locations across the septum primum105and/or septum secundum110. Although the penetration through the septum primum105and/or septum secundum110are shown at different locations, common to each of the illustrated deployments is the location of the distal anchor620and the proximal anchor621in the left and right atrial chambers respectively.

FIG. 8Fillustrates substantial closure of the PFO tract120with a single penetration through both the septum primum105and septum secundum110.

It should be noted that both the septum primum105and septum secundum110do not have to be penetrated to maintain close enough proximity between the septal tissues to achieve proper closure of the PFO.FIG. 8Gillustrates substantial closure of the PFO with a single penetration only through the septum primum105. In the illustrated embodiment, there is significant overlap between the septum primum105and septum secundum110creating a fairly long track120. The distal and proximal anchors620,621respectively are sized to exert enough force on the septum primum105and septum secundum110to facilitate closing of the PFO track120when the closure line625is tensioned.

The PFO closure device600can be used to facilitate closing the PFO track120when other defects in the septal wall are present. For example, the PFO closure device600may be used when an atrial septal aneurysm (ASA)805is present. An ASA is characterized as a saccular deformity, generally at the level of the fossa ovale, which protrudes to the right or left atrium, or both.FIG. 8Hillustrates substantial closure of the PFO, where an ASA is present, with a single penetration only through the septum primum105. However, the distal and proximal anchors,620and621respectively, are sized to contact both the septum primum105and septum secundum110to facilitate closing of the PFO track120.

The single penetration method may also be employed where there is minimal overlap between the septum primum105and septum secundum110. This so called “short tunnel” PFO may not be readily closed with prior art “intra-tunnel methods.FIG. 8Iillustrates substantial closure of the PFO with a single penetration through the septum primum105.

Similar to the single penetration method illustrated inFIGS. 8F through 8I, the closure device600may be deployed using a single penetration through the septum secundum110as illustrated inFIG. 8J.

The present invention utilizes a removable deployment device to introduce the mechanical closure device600into the atrium of the heart, preferably through a minimally invasive, transluminal procedure. One such deployment device630is shown inFIG. 6B.

Minimally invasive heart surgery refers to several approaches for performing heart operations that are less difficult and risky than conventional open-heart surgery. These approaches restore healthy blood flow to the heart without having to stop the heart and put the patient on a heart-lung machine during surgery. Minimally invasive procedures are carried out by entering the body through the skin, a body cavity or anatomical opening, but with the smallest damage possible to these structures. This results in less operative trauma for the patient. It also less expensive, reduces hospitalization time, causes less pain and scarring, and reduces the incidence of complications related to the surgical trauma, speeding the recovery.

One example of a minimally invasive procedure for performing heart surgery is a trans-thoracic laparoscopic (endoscopic) procedure. The part of the mammalian body that is situated between the neck and the abdomen and supported by the ribs, costal cartilages, and sternum is known as the thorax. This division of the body cavity lies above the diaphragm, is bounded peripherally by the wall of the chest, and contains the heart and lungs. Once into the thorax, the surgeon can gain access to the atrium of the heart through an atriotomy, a surgical incision of an atrium of the heart. For example, if the surgeon wishes to gain access to the right atrium they will perform an atriotomy in the right atrial appendage. The primary advantage of a trans-thoracic laparosopic procedure is that there is no need to make a large incision. Instead, the surgeon operates through 3 or 4 tiny openings about the size of buttonholes, while viewing the patient's internal organs on a monitor. There is no large incision to heal, so patients have less pain and recover sooner. Rather than a 6- to 9-inch incision, the laparoscopic technique utilized only 4 tiny openings—all less than ½ inch in diameter.

Another minimally invasive technique for gaining access to the heart and deploying the closure device is a percutaneous transluminal procedure. Percutaneous surgical techniques pertain to any medical procedure where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using an “open” approach where inner organs or tissue are exposed (typically with the use of scalpel). The percutaneous approach is commonly used in vascular procedures, where access to heart is gained through the venous or arterial systems. This involves a needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen of the needle. It is over this wire that other catheters can be placed into the blood vessel. This technique is known as the modified Seldinger technique. The PFO closure device600may also be deployed via percutaneous methods by steerable catheters or guidewires.

In the Seldinger technique a peripheral vein (such as a femoral vein) is punctured with a needle, the puncture wound is dilated with a dilator to a size sufficient to accommodate an introducer sheath, and an introducer sheath with at least one hemostatic valve is seated within the dilated puncture wound while maintaining relative hemostasis.

Penetration of the interatrial septum requires piecing the septal wall. In a preferred embodiment this penetration is accomplished by using a needle, trocar or similar device to accomplish non-core cutting of the interatrial septum. In one embodiment of the invention, the non-core cutting device is a tubular needle-like structure, however other configurations and shaped structures may be used as would be understood by one skilled in the art. The needle tube is a substantially rigid structure capable of penetrating the septum secundum110and septum primum105along the PFO track120. The needle is preferably sized to be 13 French or smaller, most preferably 10 French or smaller, and made from a biocompatible material, such as, for example surgical stainless steel, Nitinol, or Cobalt-Chromium alloys. It should be understood that these materials are not meant to limit the scope of the invention. Any biocompatible material capable of being sharpened and holding a sharp edge, and having sufficient strength to facilitate penetration through the septum secundum110and/or septum primum105, may be suitable. The needle is constructed with a tapered distal end, as is known in the art. In a preferred embodiment, the geometric configuration of the tapered distal end is optimized to minimize induced tissue trauma at the site of penetration. In addition, the needle is of sufficient body length to penetrate both the septum secundum110and septum primum105, while still maintaining the needed size and axial flexibility to navigate the tortuous vessel anatomy when being delivered to the heart percutaneously.

In another embodiment of the invention, penetrating the interatrial septum may be accomplished by drilling through the septum.

With the introducer sheath in place, the guiding catheter or delivery member630of the closure device is introduced through the hemostatic valve of the introducer sheath and is advanced along the peripheral vein, into the region of the vena cavae, and into the right atrium.

In one embodiment of the invention, the distal tip of the delivery device630is positioned against the interatrial septal wall. In the case of a septum having a PFO, the interatrial septal wall may be the septum primum105and/or septum secundum110, as the case may be. A needle or trocar associated with the delivery device630is then advanced distally until it punctures the septum primum105and or septum secundum110. A separate dilator may also be advanced with the needle through the septum primum105and/or septum secundum110to prepare an access port through the septum primum105and/or septum secundum110for seating the delivery device630. The delivery device630traverses across the septum and is seated in the left atrium, thereby providing access for closure devices600through its own inner lumen and into the left atrium.

It is however further contemplated that other left atrial access methods may be suitable substitutes for using the delivery device630and closure device600of the present invention. In one alternative variation not shown, a “retrograde” approach may be used, wherein the delivery device630is advanced into the left atrium from the arterial system. In this variation, the Seldinger technique is employed to gain vascular access into the arterial system, rather than the venous, for example, at a femoral artery. The delivery device630is advanced retrogradedly through the aorta, around the aortic arch, into the ventricle, and then into the left atrium through the mitral valve.

Once in the desired atrium of the heart the closure device600is deployed transeptally from one atria to the other. For the purpose of this invention, transeptally is defined as deployment from one atria to the other through the septum (septum primum105and/or septum secundum110), as apposed to intra-atrial access through the PFO tract120(tunnel). In the case of a heart having a patent foramen ovale, transeptal penetration may be through the septum primum (SP)105and/or septum secundum (SS)110, or visa versa, whichever the case may be. Preferably, the angle of transeptal penetration is between 45 and 135 degrees to the surface of the septum, but is most preferably orthogonal to the surface of the septum.

By way of example, in one embodiment of the present invention using right atrial access, the right atrium is first accessed by the delivery device630(and closure device600). The closure device600may then be deployed by penetrating the interatrial septum (septum primum105and/or septum secundum110) from the right atrial chamber to the left atrial chamber in the heart, and deploying the distal anchor620associated with the closure device600into the left atrial chamber. After successful deployment of the distal anchor620, the delivery device630may be partially withdrawn from the left atrial chamber to the right atrial chamber, leaving the distal anchor620in place. The proximal anchor621associated with the closure device600can then be deployed into the right atrial chamber. This substantially linear atrial deployment method is shown inFIGS. 8F through 8J.

In another embodiment of the invention, the right atrium is first accessed by the delivery device630(and closure device600). The closure device600may then be deployed by penetrating the interatrial septum (septum primum105and/or septum secundum110) from the right atrial chamber to the left atrial chamber in the heart. Once in the left atrial chamber, the delivery device630(and closure device600) are turned and re-penetrate the interatrial septum (septum primum105and/or septum secundum110) from the left atrial chamber to the right atrial chamber in the heart though a different access point. The various preferred access points are shown inFIGS. 8A through 8E. Once back in the right atrial chamber of the heart, the distal anchor620may be deployed. After successful deployment of the distal anchor620, the delivery device630may be partially withdrawn from the right atrial chamber to the left atrial chamber, leaving the distal anchor620in place in the right atrium. The delivery device630may then be withdrawn back through the interatrial septum (septum primum105and/or septum secundum110) from the left atrium to the right atrium. The proximal anchor621associated with the closure device600can then be deployed into the right atrial chamber.

Similar procedures are employed when left an atrial access technique is used. For example, in one embodiment of the present invention using left atrial access, the left atrium is first accessed by the delivery device630(and closure device600). The closure device600may then be deployed by penetrating the interatrial septum (septum primum105and/or septum secundum110) from the left atrial chamber to the right atrial chamber in the heart, and deploying the distal anchor620associated with the closure device into the first atrium. After successful deployment of the distal anchor620, the delivery device630may be partially withdrawn from the right atrial chamber to the left atrial chamber, leaving the distal anchor620in place. The proximal anchor621associated with the closure device can then be deployed into the left atrial chamber.

Once the proximal anchor is deployed, the closure device may be cinched to bring the proximal and distal anchors closer together. This results in the septum secundum110and the septum primum105being brought in close proximation to facilitate closure of the Patent Foramen Ovale. It should be noted that the septum secundum110and the septum primum105do not have to be tightly touching to effect proper closure of the PFO. Instead, the septum secundum110and the septum primum105must just be brought close enough to minimize flow from atria to atria (typically flow from right atria to left atria).

To achieve and maintain the proximity between the septum secundum110and the septum primum105, it may be necessary to adjust the proximal anchor by uni-axially cinching or sliding the proximal anchor620along closure line625. In one embodiment of the invention, cinching comprises uni-axially adjusting the proximal anchor relative to a closure line associated with the closure device. In another embodiment of the invention, cinching comprises incrementally adjusting the proximal anchor relative to a closure line associated with the closure device.

Once the closure device is cinched in place the method may further comprise assessing the degree of proximation between the septum secundum110and the septum primum105.

In one embodiment of the invention, the clinician may visually assess the proximation though an endoscopic or fluoroscopic procedure. In addition, other methods may be used to measure the proximation between the septum secundum110and the septum primum105, such as through pressure observation or infrared imaging.

After proper cinching, any unwanted length of closure line625that remains unconstrained within the right atrium may be mechanically removed. Devices known in the art capable of removing the excess closure line625include catheter-based snare and cut devices. In addition to independent devices, a mechanical cut and removal mechanism may be integrated into the deployment device.

The closure device will then be in position, with the anchors620,621opened against the septum secundum110, and the closure line625connecting the anchors620,621through the septum primum105and septum secundum110, thus holding the septum primum105in place.

In one embodiment of the invention, the removable deployment device630comprises three tube-like structures that are coaxially aligned. However, other configurations and shaped structures may be used as would be understood by one skilled in the art. The first outer tube605is a substantially rigid needle like structure capable of penetrating the septum secundum110and/or septum primum105along the PFO track120. The outer needle605is preferably sized to be 10 French or smaller and made from a biocompatible material, such as, for example surgical stainless steel, Nitinol, or Cobalt-Chromium alloys. It should be understood that these materials are not meant to limit the scope of the invention. Any biocompatible material capable of being sharpened and holding a sharp edge, and having sufficient strength to facilitate penetration through the septum secundum110and/or septum primum, may be suitable. The outer needle605is constructed with a tapered distal end, as is known in the art. In a preferred embodiment, the geometric configuration of the tapered distal end is optimized to minimize induced tissue trauma at the site of penetration. In addition, the outer needle605is of sufficient body length to penetrate both the septum secundum110and septum primum105, while still maintaining the needed size and axial flexibility to navigate the tortuous vessel anatomy when being delivered to the heart100.

The second or inner tube-like structure is inner needle610. The inner needle610is substantially coaxial with outer needle605and diametrically sized such that the inner needle610is slideably engaged within outer needle605. That is to say, the outside diameter of inner needle610is smaller than the inner bore diameter of outer needle605, allowing the inner needle610to telescope from outer needle605.

The inner needle610is substantially straight when constrained inside outer needle605, but is capable of assuming a curved shape after being telescopically released from the distal end of outer needle605. This curved shape may be assumed by mechanical manipulation, such as through manipulation of a pullwire, or preferably by some inherent characteristic or property of the inner tube610. These inherent characteristics and properties may include fabricating the inner tube610with features, such as circumferential kerf cuts and/or axially spiraling strain relief cuts that allow the inner tube610to naturally curve in the desired direction, or preferably, by fabricating the inner tube610from a material having shape memory characteristics. In addition, kerf cuts and axially spiraling strain relief cuts may be used on materials having shape memory characteristics.

In a preferred embodiment, the inner needle610is fabricated to resume a pre-determined configuration when telescoped from outer needle605. As can be seen in the embodiment illustrated inFIG. 6, the inner needle610resumes a “U-Shape” configuration. One material exhibiting shape memory or super-elastic characteristics is Nitinol.

Nitinol is utilized in a wide variety of applications, including medical device applications as described above. Nitinol or NiTi alloys are widely utilized in the fabrication or construction of medical devices for a number of reasons, including its biomechanical compatibility, its biocompatibility, its fatigue resistance, its kink resistance, its uniform plastic deformation, its magnetic resonance imaging compatibility, its ability to exert constant and gentle outward pressure, its dynamic interference, its thermal deployment capability, its elastic deployment capability, its hysteresis characteristics, and is moderately radiopaque.

Nitinol, as described above, exhibits shape memory and/or super-elastic characteristics. Shape memory characteristics may be simplistically described as follows. A metallic structure, for example, a Nitinol tube that is in an Austenitic phase may be cooled to a temperature such that it is in the Martensitic phase. Once in the Martensitic phase, the Nitinol tube may be deformed into a particular configuration or shape by the application of stress. As long as the Nitinol tube is maintained in the Martensitic phase, the Nitinol tube will remain in its deformed shape. If the Nitinol tube is heated to a temperature sufficient to cause the Nitinol tube to reach the Austenitic phase, the Nitinol tube will return to its original or programmed shape. The original shape is programmed to be a particular shape by well-known techniques.

Super-elastic characteristics may be simplistically described as follows. A metallic structure for example, a Nitinol tube that is in an Austenitic phase may be deformed to a particular shape or configuration by the application of mechanical energy. The application of mechanical energy causes a stress induced Martensitic phase transformation. In other words, the mechanical energy causes the Nitinol tube to transform from the Austenitic phase to the Martensitic phase. By utilizing the appropriate measuring instruments, one can determined that the stress from the mechanical energy causes a temperature drop in the Nitinol tube. Once the mechanical energy or stress is released, the Nitinol tube undergoes another mechanical phase transformation back to the Austenitic phase and thus its original or programmed shape. As described above, the original shape is programmed by well know techniques. The Martensitic and Austenitic phases are common phases in many metals.

Medical devices constructed from Nitinol are typically utilized in both the Martensitic phase and/or the Austenitic phase. The Martensitic phase is the low temperature phase. A material is in the Martensitic phase is typically very soft and malleable. These properties make it easier to shape or configure the Nitinol into complicated or complex structures. The Austenitic phase is the high temperature phase. A material in the Austenitic phase is generally much stronger than the material in the Martensitic phase. Typically, many medical devices are cooled to the Martensitic phase for manipulation and loading into delivery systems. When the device is deployed at body temperature, they return to the Austenitic phase.

Other materials that have shape memory characteristics may also be used, for example, some polymers and metallic composition materials. It should be understood that these materials are not meant to limit the scope of the invention. Any biocompatible material capable of being sharpened and holding a sharp edge, and having sufficient strength to facilitate penetration through the septum secundum110and/or septum primum, may be suitable. The inner needle610is constructed with a tapered distal end, as is known in the art. In a preferred embodiment, the geometric configuration of the tapered distal end is optimized to minimize induced tissue trauma at the site of penetration.

Regardless of the material used, the inner needle610must be flexible enough to remain substantially straight when constrained inside outer needle605, but rigid enough to puncture through the septum secundum110and septum primum105once deployed from the distal end of outer needle605.

The third concentric tube-like structure is plunger615. Similar to the relationship between the outer needle605and inner needle610, the plunger615is substantially coaxial with inner needle610and diametrically sized such that the plunger615is slideably engaged with inner needle610. That is to say, the outer diameter of plunger615is smaller than the inner bore diameter of inner needle610, allowing the plunger615to be pushed through and telescope from inner needle610. In the illustrated embodiment, plunger615is also appropriately sized to push anchor620from the distal end of the inner needle610.

During deployment, plunger615pushes against anchor620until anchor620is deployed from the distal end of inner needle610. The movement of anchor620necessarily translates, through closure line625, to movement of anchor621. Accordingly, the inside diameter of plunger615is smaller than the outside diameter of anchor620. Conversely, the outside diameter of anchor620must be smaller than the inside diameter of inner needle610. Anchor621slides through plunger615when pulled by anchor620via closure line625. Accordingly, the outside diameter of anchor621must be smaller than the inside diameter of plunger615.

In one embodiment of the invention, the plunger615is made from a flexible material such that it can be deformed by inner needle610upon inner needle610's release from the distal end of outer member605. Flexibility may also be imparted to the plunger615by geometry, such as fabricating the plunger615from spring steel into a tightly wound coil. However, the plunger615must also have the necessary longitudinal stiffness or “pushability” to be able to deploy the closure device600from the distal end of inner needle610. In a preferred embodiment, the plunger615is made from stainless steel, Nitinol, or Cobalt-Chromium alloy, but any material exhibiting the desired characteristics of flexibility and push-ability may be used.

Another embodiment of the invention may include a location monitoring system to facilitate placement of the deployment device630. In particular, the location monitoring device will assist in determining whether the clinician is in the correct chamber of the heart.

In a preferred embodiment, the location monitoring system includes the ability to measure localized pressure relative to the distal end of the deployment device630. The pressure measurement read by the location monitoring system may be achieved by electronic, mechanical and/or physical means, such as a solid-state pressure transducer, spring loaded diaphragm, hydraulic pressure port, and/or communicating manometer. These and other pressure measurement techniques would be known by one of skill in the art.FIG. 10is a perspective view illustrating exemplary sensors, such as a hydraulic pressure port655or electrical pressure transducer660.

By way of example it is well known that pressures vary in different locations within the cardiovascular system. Specifically, gage pressure in the right and left atrium are know to range from approximately 1-6 mmHg to 10 mmHg respectfully. Similarly, gage pressure within the ascending aorta ranges from approximately 120 to 160 mmHg during systole.

Before deployment, the clinician will first monitor pressure within the right atrium. This reading should indicate a pressure of 1-6 mmHg. The distal end of the outer needle605will be inserted through the septal wall (septum primum105and/or septum secundum110) and into the left atrium. The monitored pressure should change to approximately 10 mmHg. A much higher reading, such as in the range of approximately 120 to 160 mmHg, indicates puncture of the aorta. The clinician will then have to retract the outer needle605and reposition the delivery device630for re-entry. Similarly, once in the left atrium the inner needle610is advanced back into the right atrium. The clinician should observe a pressure change from 10 mmHg to 1-6 mmHg.

For delivery to the heart, the deployment device630(and thus the closure device600) is used in conjunction with an accessory device (not shown) known in the art. In a preferred embodiment, the accessory device may be a guiding catheter that tracks over a guidewire, and is steered through the vasculature into the right atrium.

In another embodiment, the accessory device and deployment device630may be formed as an integrated component, capable of being steered through the vasculature.

To facilitate deployment of the closure device600, the deployment device630may include features that provide backup support. This backup support may include, for example: an axially asymmetric expansion member attached along an outer shaft635, such as a balloon or self expanding cage640; a spline645; or imparting a shape650along the body of the deployment device630. Examples of these backup support features are illustrated inFIGS. 9A through 9C, respectively. It should be understood that the outer shaft635may be part of the guiding catheter, or integrated into the deployment device630. These and other such backup support devices would be understood by one of skill in the art. These backup support features can also be incorporated onto accessory devices, such as the guide catheter.

Still other embodiments utilizing known methods and apparatus to deliver the deployment device630and closure device600into the atrium of heart100would be obvious to one of skill in the art.

In one embodiment of the invention, the deployment device630is part of a guiding catheter assembly. The distal tip of a guiding catheter comprising the deployment device630is first positioned within the left atrium according to a transeptal access method, which is further described in more detail as follows. The right venous system is first accessed using the “Seldinger” technique, wherein a peripheral vein (such as a femoral vein) is punctured with a needle, the puncture wound is dilated with a dilator to a size sufficient to accommodate an introducer sheath, and an introducer sheath with at least one hemostatic valve is seated within the dilated puncture wound while maintaining relative hemostasis. With the introducer sheath in place, the guiding catheter or sheath is introduced through the hemostatic valve of the introducer sheath and is advanced along the peripheral vein, into the region of the vena cavae, and into the right atrium.

Once in the right atrium, the distal tip of the guiding catheter is positioned against the septum secundum110in the intra-atrial septal wall. The deployment device630is then advanced distally until the outer needle605punctures through both the septum secundum110and septum primum105into the left atrium. The configuration of the deployment device,630, including closure device600puncturing through the septum secundum110and septum primum105is shown inFIG. 11.

Once the deployment device630penetrates through both the septum secundum110and septum primum105, the inner needle610is advanced from the distal end of the outer needle605into the left atrium. As earlier described the inner needle610is constructed from a shape memory material and designed to assume a curved shape when telescopically released from the outer needle605.FIG. 12illustrates the configuration of the deployment device630and closure device600after the inner needle610is advanced from the distal end of the outer needle605into the left atrium.

After the inner needle610is deployed from the distal end of the outer needle605, the deployment device630is pulled back until the inner needle610penetrates through the septum primum105and septum secundum110, respectively, into the right atrium. In one embodiment of the invention, this is accomplished by ensuring that the inner needle610remains fixed relative to outer needle605, and then withdrawing the outer needle from the left atrium until the inner needle610makes the necessary penetration into the right atrium.FIG. 13illustrates the final position of the deployment device630and closure device600after the inner needle610penetrates into the right atrium.

After the inner needle610has penetrated the septum primum105and septum secundum110into the right atrium, the distal anchor620can be deployed. As earlier described, the anchor620is deployed into the right atrium by holding the inner needle610steady, and advancing the plunger615through the inner needle610. During deployment, plunger615pushes against the back portion of anchor620until anchor620is advanced from the distal end of inner needle610. The movement of anchor620necessarily translates, through closure line625, to movement of anchor621. As anchor620enters the right atrium the shape memory material properties allow the anchor620to assume it unconstrained shape.FIG. 14illustrates the anchor620deployed from the inner needle610by the plunger615according to one embodiment of the present invention.

To deploy proximal anchor621, the inner needle610is retracted back through outer needle610to a position indicated inFIG. 15. This will leave the plunger615and the closure assembly in place penetrating the septum primum105and septum secundum110in two places. The anchor621will remain in the constrained position inside plunger615. The plunger615is then retracted back through both outer needle605and inner needle610as shown inFIG. 16. This will leave the closure device600in place, with anchor620fully deployed against the septum secundum110, and anchor621constrained inside outer needle605. The outer needle605can then be withdrawn from the septum primum105and septum secundum110respectively, releasing the anchor621to the fully unrestrained shape. If necessary, anchor621may be slid toward anchor620along closure line625until sufficient compression is achieved between septum primum105and septum secundum110. Any unwanted length of closure line625that remains unconstrained within the right atrium may be mechanically removed. Devices known in the art capable of removing the excess closure line625include catheter-based snare and cut devices. In addition to independent devices, a mechanical cut and removal mechanism may be integrated into the deployment device630.

The closure device will then be in position, with the anchors620,621opened against the septum secundum110, and the closure line625connecting the anchors620,621through the septum primum105and septum secundum110, thus holding the septum primum105in place.

FIG. 17illustrates the closure device600in the fully deployed position.

These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading of the detailed description of this invention including the associated drawings.

Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims the invention might be practiced otherwise than as specifically described herein.