CN1780589A - Energy based devices and methods for treatment of patent foramen ovale - Google Patents

Abstract

A process, a device and a system for curing patent foramen oval (PFO) are disclosed. The process comprises advancing a pipe guide to one position in a heart which is convenient for curing the PFO, at least partially gathering tissues which are close to the PFO, exerting energy on the tissues, thereby basically rapidly closing the PFO. The pipe guide generally comprises an elongated pipe body, at least one tissue adherence component on the distal end or the vicinity of the distal end which is used to gather the tissues and at least one energy transport component on the distal end or the vicinity of the distal end which is used to exert energy on the tissues. The tissue adherence component also is used as the energy transport component in some examples. The energy which is exerted can be monopole radio frequency energy or bipolar radio frequency energy, or any other suitable energy such as laser, microwave, supersonic wave and resistance heating, etc.

Description

Energy-based devices and methods for treating patent foramen ellipsoid

related application

This application claims priority to the following U.S. Provisional Patent Applications: Nos. 60/458,854 filed March 27, 2003 (Attorney Docket No. 022128-000100US); Nos. 60/ 478,035 (Attorney Docket No. 022128-000110US); Nos. 60/490082 filed July 24, 2003 (Attorney Docket No. 022128-000120US); incorporated herein by reference in their entireties. This application is related to the following U.S. patent applications: Nos. 10/665974 filed September 16, 2003 (Attorney Docket No. 022128-000300US); Nos. 10/679245 filed October 2, 2003 (Attorney No. 022128-000200US); Nos. 10/787532 filed February 25, 2004 (Attorney Document No. 022128-000130US); and Nos. 10/_______ (Attorney Document No. 022128-000130US) filed concurrently with this application No. 022128-000400US), the entire contents of which are incorporated herein by reference.

technical field

The present invention generally relates to medical devices and methods. In particular, the present invention relates to energy-based devices, systems and methods for treating patent foramen ovale.

Background technique

The blood circulation of a fetus is very different from that of an adult. Because fetal blood is oxygenated by the placenta and not by the fetal lungs, blood is generally shunted away from the lungs to surrounding tissues through multiple blood vessels and pores that remain open (ie, open) during fetal life, Usually the patent foramen closes soon after birth. For example, fetal blood flows from the right atrium through the foramen oval directly into the left atrium, and part of the blood that circulates through the great vessels of the pulmonary artery flows through the ductus arteriosus to the aorta. This cycle of the fetus is shown in Figure 1 of the accompanying drawings.

When the fetus is born, a new life begins to breathe, and the blood pressure in the left atrium is higher than the blood pressure in the right atrium. In most babies, a flap of tissue closes the foramen oval and heals together. About 20,000 babies are born each year in the United States without this tissue flap, so the hole remains open, known as an atrial septal defect (ASD). In a higher percentage of the population (estimates range from 5% to 20% of the population), skin flaps are present but do not heal together. This case is called a patent foramen ellipsoid (PFO). Every time the blood pressure in the right atrium is higher than the blood pressure in the left atrium, the blood pressure pushes open the patent oval foramen, allowing blood to flow from the right atrium to the left atrium.

Because the patent foramen ellipsoid usually has little effect on the blood circulation of the whole body, it has been considered a relatively benign case. More recently, however, it has been discovered that a significant number of people experience a sudden loss of brain function, at least in part, due to PFO. In some cases, sudden brain function can be caused because the PFO allows blood containing small clots to flow directly from the venous circulation to the arterial circulation and into the brain, rather than into the lungs, where the clots can become trapped and gradually dissolve lost. In other cases, a thrombus can form in the open channel of the PFO itself and be dislodged when blood pressure causes blood to flow from the right atrium to the left atrium. It is estimated that PFO patients who have experienced a sudden loss of brain function of unknown etiology are at an annual risk of 4% for another sudden loss of brain function.

Further research is now linking PFO to sudden loss of brain function. Currently, if a person with a PFO experiences two or more sudden loss of brain function, the US health care system reimburses for surgical or other interventions to definitively close the PFO. However, it may well be possible to obtain a more preventive approach to closing the PFO to prevent sudden loss of brain function in the future. However, since the morbidity due to PFO is relatively low, the cost and possible side effects and complications of such a procedure must be low. For example, in young patients, the PFO sometimes closes itself over time without any adverse health effects.

Another prevalent and debilitating condition - chronic migraine - is also associated with PFO. Although the exact reason has not been explained, closure of the PFO has been shown to eliminate or significantly reduce migraine in many patients. Furthermore, prophylactic PFO closure may be warranted for the treatment of chronic migraine if a relatively non-invasive procedure is available.

Currently available interventional treatments for PFO are often relatively invasive treatments and/or have potential disadvantages. One strategy is to simply close the PFO during open heart surgery performed for other purposes, such as heart valve surgery. This is usually accomplished with a simple procedure, eg, one or two stitches on the PFO with vascular sutures. However, it is difficult to justify performing open-heart surgery purely to close an asymptomatic PFO or even a very small ASD.

A number of percutaneous interventional devices for closing the PFO have been proposed and developed. Most of these devices are the same or similar to ASD shutdown devices. They are usually "clamshell" or "double umbrella" shaped devices that deploy an area of biocompatible metal mesh or fabric (e.g., ePTFE or Dacron) on each side of the atrial septum, along with a central axial element Hold in place to close the PFO. The umbrella then heals into the atrial septum, with the healing response forming a uniform layer of tissue or "pannus" over the device. For example, such devices have been developed by companies such as Nitinol Medical Technologies, Inc. (Boston, MA) and AGA Medical, Inc. (White Bear Lake, MN). US Patent No. 6,401,720 describes a method and apparatus for thoracoscopic endocardiac surgery, which may be used in the treatment of PFO.

While the provided devices work well in some cases, they also present a number of challenges. For example, complications have fairly frequently resulted in improper deployment, embolization of the device into the circulation, and fracture of the device, among others. In some instances, a deployed device does not fully heal into the septal wall, leaving exposed tissue that itself can become a foci for thrombosis. Furthermore, currently available devices are often complex and expensive to manufacture, making their use in the prophylactic treatment of PFO impractical. Additionally, currently available devices typically close a PFO by placing material on either side of the PFO tunnel, compressing and sharply opening the tunnel until blood clots on the device and causes flow to stop.

Research into methods and compounds for tissue welding has been carried out for many years. Such a study is described, for example, in "Feedback-Controlled Bipolar Container Sealing for High Burst Strength" by Kennedy et al., Surg. Endosc. (1998) 12:876-878. Of particular interest are those developed by McNally et al. (as shown in US Patent No. 6,391,049) and Fusion Medical (as shown in US Patent Nos. 5,156,613, 5,669,934, 5,824,015, and 5,931,165). These techniques all reveal energy delivered to tissue junctions and patches in order to connect tissues and create healing between arteries, bowels, nerves, and more. Also of interest are several patents filed by inventor Sinofsky that relate to laser suturing biological materials (eg, US Patent Nos. 5,725,522, 5,569,239, 5,540,677, and 5,071,417). However, none of these disclosed inventions demonstrate methods or devices suitable for positioning PFO tissue for welding or delivering energy to the PFO to be welded.

In two patent applications by Stambaugh et al. (PCT Publications Nos. WO99/18870 and WO99/18871), thermal burns to patent foramen ovale are described. However, the described devices and methods cause burns to the PFO tissue and it is hoped that eventually scab tissue will form to close the PFO. Using such devices and methods, the PFO remains virtually open right after surgery, only closing (if it closes at all) at a later time. Therefore, the surgeon does not know whether the treatment is working until long after the treatment operation has been done. Often, scab tissue may not form, or may not fully form resulting in a still open PFO.

Accordingly, it would be advantageous to have improved methods and devices for treating PFO. Ideally, such methods and devices would assist in sealing the PFO during, immediately, or shortly after a therapeutic procedure is performed. It would also be desirable that such devices and methods would leave no foreign material (or very little material) inside the patient's heart. Furthermore, such methods and devices are preferably relatively simple to manufacture and use, thus rendering prophylactic treatment of PFO, eg, preventing sudden loss of brain function, a viable option. The present invention will satisfy at least some of the above objects.

Contents of the invention

The present invention generally provides methods, devices and systems for treating patent foramen ovale (PFO). As described in various embodiments, a PFO may be closed substantially sharply by at least partially bringing together tissue adjacent to a patent foramen ovale using a catheter device and applying energy to the tissue. The so-called "basically" refers to the formation of a stable tissue bridge that can withstand physiological pressure across the PFO. However, a substantially closed PFO may still have one or more small gaps or openings that, at least in some cases, close over time through the healing process. By "sharply" is meant that the PFO is substantially closed when the closing procedure is completed. Thus, the abrupt closure differentiates the embodiments described below from the prior art, which is based on delayed closure of the PFO by tissue healing and scarring. "Acutely" does not imply a temporary meaning for the purposes of this application, as various embodiments generally provide permanent (or at least long-term) closure of the PFO.

The phrase "tissue adjacent to a PFO," or simply "PFO tissue," for the purposes of this application, means any tissue within, around, or near the PFO that can be used or manipulated to help close the PFO. organize. For example, tissue adjacent to a PFO includes tissue of the first atrial septum, tissue of the second atrial septum, tissue of the atrial septum lateral to the first or second atrial septum, tissue within the tunnel of the PFO, the right atrial surface of the atrial septum, or Tissue on the surface of the left atrium, etc. By "applied energy" is meant that energy can be transmitted to or from the PFO tissue. For example, if cryogenic energy is applied, thermal energy can be said to be transported out of the tissue. In various embodiments, any number of energy transfer devices and energy forms may be used to provide such energy transfer. For example, the type of energy employed may include radio frequency energy, cryogenic energy, laser energy, ultrasonic energy, resistive heating energy, microwave energy, and the like.

Applying energy to tissue to substantially sharply PFO is sometimes referred to as "tissue welding." Preferably, the tissue welding methods of the present invention are performed without the use of tissue binders or other foreign materials. However, in certain embodiments, one or more solder materials may be used to advantage. Various combinations and other tissue welding materials are more fully described in US Patent Application No. 10/665,974, previously incorporated by reference. Examples of tissue binders or adhesives that may be used include, but are not limited to: body blood, albumin, collagen, fibrin, cyanoacrylate adhesives, clam silk adhesives, polymeric hot melt Adhesives etc.

Certain embodiments described below provide for bringing together (or "attaching" tissue) tissue adjacent to a PFO. In various embodiments, attachment of tissue can be performed before, during, and/or after applying or removing energy to the tissue. Generally, the application or removal of energy will serve to modify the collagen within the PFO tissue. If the tissue is attached before and/or during modification while the collagen within the tissue is modified again, the collagen within the once separated tissue will stick together to assemble the tissue. Accordingly, certain embodiments include one or more devices that gather (and possibly maintain) tissue before, during, and/or after application or removal of energy. By providing substantially abrupt closure of a PFO, the devices, systems and methods may advantageously prevent sudden loss of brain function, treat migraines, and/or prevent or treat other medical conditions caused or exacerbated by the PFO.

In one aspect of the invention, a method of treating a PFO includes advancing a catheter device to a location within the heart to treat a patent foramen ellipsoid, and at least partially bringing together tissue adjacent to the PFO with the catheter device, and using the catheter device to Energy is applied to the tissue, essentially closing the PFO sharply. In some embodiments, the tissue is brought together prior to applying energy. Alternatively, the tissue can be held together while energy is applied. In certain embodiments, the tissue may also be held together after energy is applied to allow the tissue to cool, reformulate, turn off the PFO, and/or the like. Optionally, the method further comprises effectively cooling the tissue after application of the energy.

In some embodiments, after energy is applied, the catheter device can be moved to a different position relative to the PFO, the tissue can be brought together again, and energy can be applied again. Certain embodiments include multiple repetitions of the steps of moving, gathering, and applying energy. In such embodiments, the PFO can be substantially closed with the catheter device by moving along the FPO, typically from one side of the PFO to the other, bringing the tissue together, and applying energy multiple times. Such a method may be referred to as "spot welding" of the PFO tissue. In certain embodiments, one or more biasing features on the catheter may be used to bias the side of the catheter toward the PFO. For example, the shape of the catheter body, an expandable member, a biased wire, etc. can help push the catheter to one side. Typically, the catheter is movable across the PFO, bringing tissue together and applying energy at multiple locations along this path. In one embodiment, for example, tissue attachment members (which may also be configured to apply energy to tissue) compress tissue between the members. As they do so, they also squeeze a shaped catheter between tissue, the cross-sectional shape of the catheter body being such that it is pushed into a new position as the tissue is squeezed down. For example, the catheter body may have a triangular, oval, diamond or other shape. After applying energy at the first location, the tissue attachment member moves to the second location and again presses down on the tissue and catheter body, thereby pushing the catheter body to a third location and so on.

A variety of other suitable techniques are also contemplated for moving across the PFO and "spot welding" the tissue. In another embodiment, for example, a large stationary electrode is positioned in the right or left atrium, while a smaller moving electrode is moved along the PFO in the other atrium to form a spot weld. In other embodiments, one or more electrodes may rotate around the circumference of the PFO.

Advancing the catheter device to a location within the heart to treat the PFO may be accomplished using any suitable technique. In some embodiments, for example, a first distal portion of the catheter is advanced to a location within the right atrium, and the first distal portion is used to bring tissue together. In some embodiments, a second distal portion can be advanced into or through the PFO, and the first and second distal portions are then used to attach tissue. In some embodiments, the second portion extends through the PFO and into the left atrium such that the first portion contacts tissue from the right atrium side and the second portion contacts tissue from the left atrium side. In various embodiments, one or both parts can then be manipulated to bring tissue together between them. For example, one or both parts may move axially towards each other. In some embodiments, one portion moves axially toward the other portion, which remains relatively stationary to act as a "backstop" or surface against which to bring the tissue together. A number of such backstops are described in patent applications Serial Nos. 60/458,854, 60/478,035 and 60/490082, which were incorporated by reference above. Alternatively, either one or both parts can also be used to apply energy to the tissue.

At least partially bringing the tissues together may be accomplished in any number of suitable ways. For example, as just described, the first and/or second distal end portions of the catheter device can be moved toward each other to capture, pinch, pinch, grasp or otherwise attach tissue between the two components. In another embodiment, tissue may be brought together by expanding one or more expandable members. For example, an expandable member may expand within the right or left atrium to push against the tissues and thereby bring them together. In another embodiment, one expandable member may expand in the right atrium while a second expandable member expands in the left atrium, the expansion causing tissue to compress together between the two members. Similar results can be achieved by using an expandable member and a "backstop" member, as described above. Certain embodiments also include moving one expandable member toward the other to further bring tissue together. For example, one expandable member may slide axially along the catheter device toward the other expandable member. Again, any suitable technique may be used.

In other variant embodiments, bringing the tissue together may include deploying an expansion member within the PFO. An expansion member, such as a bifurcated "fish mouth" shaped member, is typically placed within a sheath while advancing into the PFO. Then, the sheath is retracted to allow the prongs to spread apart from each other. Such an inflatable "fish mouth", two prongs can be constructed of shape memory materials, spring loaded materials, and the like. By spreading the PFO laterally between the two prongs, the tissue is brought together in the area between the two prongs. In certain embodiments, one or more expandable members may be coupled to the prong or catheter device to further assist in engaging the tissue together. Optionally, the method may further comprise contacting the left atrial surface of at least one of the first interatrial septum and the second interatrial septum with a distal portion of the expandable member, and retracting the expandable member to bring together tissue adjacent the PFO together. For example, the distal portion may contact the first interatrial septum and draw it toward the right side of the heart to contact the second interatrial septum. At some point after the expansion member is used to attach tissue adjacent the PFO, it may be advantageous to retract the expansion member to a position within the catheter device. In some embodiments, for example, the expansion member can be retracted prior to removal of the catheter device.

In other embodiments, the first distal end portion and/or the second distal end portion of the catheter device may be advanced into tissue adjacent the PFO. In other words, one or more portions of the catheter device may be caused to penetrate into the PFO of adjacent tissue. For example, such an embodiment may include the use of a jaw-like device such that the first and second tissue attachment members comprise opposing jaws. In one embodiment, for example, the first distal portion is advanced into the second interatrial septal tissue. Optionally, the second distal portion may be advanced into the first interatrial septal tissue. The first and second tissue-attachment members can then move together to bring the tissue together. In yet another embodiment, a jig-like device may be used that may or may not pierce tissue. With the clip, one part of the clip can contact tissue from the right atrium and another part can contact tissue from the left atrium. Again, any of a number of other suitable techniques, some of which are more fully described in U.S. Patent Application Nos. 60/458,854, 60/478,035, 60/490082, 10/665974, and 10/679245 , which are all cited above for reference.

In some embodiments, the catheter device is advanced over a guide wire. The guidewire typically extends through the PFO and may include an extension along its length for extending within the PFO. Optionally, the guide wire can be extended into the left atrium, the method optionally comprising: contacting a left atrial surface of at least one of the first interatrial septum and the second interatrial septum with a distal portion of the guide wire, and The guide wire is retracted to bring together the tissue adjacent to the PFO.

Any suitable type of energy can be applied to the PFO tissue to provide abrupt closure of the PFO. In some embodiments, for example, monopolar or bipolar radio frequency energy may be applied, while in other variant embodiments cryogenic, resistive heating, ultrasonic, microwave or laser energy, heating fluids such as saline may be applied. form of heat, etc. In various embodiments, energy is applied by energizing a single conductive member or multiple conductive members of the catheter device. In general, any suitable means for supplying energy may be considered. In one embodiment, applying energy to the tissue includes applying energy to a conductive fluid and releasing the conductive fluid from the catheter device to contact the tissue. For example, a conductive fluid such as saline can be introduced into one or more expandable components of a catheter device, energy such as radio frequency energy can be applied to the fluid, and the fluid is then passed from the expandable components through the inflatable components. At least one (preferably a plurality) of apertures are released. The energized conductive fluid can then contact tissue to close the PFO.

Certain embodiments of the method may also include monitoring the energy applied to the tissue. For example, monitoring energy may include monitoring tissue temperature, tissue impedance, and/or the like. Such a method may also include determining when sufficient energy has been supplied to the tissue to shut down the PFO abruptly. Optionally, the method may further include ceasing the application of energy when sufficient energy has been applied.

Any of the above methods may further include directly viewing the PFO and adjacent tissue with at least one visualization device coupled to the catheter device. Such a visualization device may include a fiber optic device, an ultrasound device, or any other suitable visualization device.

In another aspect of the invention, a method of treating a patent foramen ellipsoid in the heart comprises: advancing a catheter device to a location within the heart to treat the patent foramen ellipsoid; The tissue of the hole is brought together; applying energy to the tissue with the catheter device while at least partially holding the tissue together; and at least partially holding the tissue together for a sufficient time after applying the energy to substantially close Closed oval hole. Such a method may include any of the features of the embodiments described above.

In another aspect of the invention, a catheter device for treating a patent foramen ovale in the heart includes an elongated catheter body having a proximal end and a distal end positioned at or near the distal end of the catheter body for at least one tissue attachment member at least partially bringing together tissue adjacent to the patent foramen ovale, and at least one energy delivery member located at or near the distal end to apply energy to the tissue to substantially close the PFO abruptly . In some embodiments, the at least one tissue attachment member includes a first tissue attachment member for contacting tissue from the right atrium of the heart. Optionally, in various embodiments, a second tissue attachment member may be included for accessing tissue from either the right atrium or the left atrium. For example, in one embodiment, the first and second members may comprise a set of opposing jaws that may be used to bring tissue together from within the right atrium, optionally advanced through one or more adjacent PFOs. organization. In certain embodiments, the second portion may be advanced through the PFO to contact tissue from the left atrium. Any number of different tissue attachment surfaces can be included.

As noted above, for example, one or both of the first and second tissue attachment members may comprise expandable members, either (or both) being slidable axially toward each other to gather tissue therebetween. In other embodiments, an expandable member and a shape-expandable "backstop" member may be used. For example, the expandable member can include a shape memory device that can be advanced into the left atrium and deployed to contact tissue. An inflatable balloon is deployable and movable axially along the catheter to collect tissue between it and the deployed backstop. Any one or more of such expandable members may also include at least one aperture to allow conductive fluid to escape from the expandable member to contact tissue. Some embodiments include multiple apertures, and some embodiments include two expandable members with apertures.

In other embodiments, the first and second tissue attachment members are configured as two arms of a clamp, with one arm positioned within the right atrium and the other positioned within the left atrium to clamp tissue together. Still other embodiments include a set of opposed jaws and a hook or clamp member to orient tissue toward the clamps. In other embodiments, the first and second portions are configured as a clip, "hair clip," etc., wherein the opposing shapes of the first and second attachment members push the tissue together. For example, in one embodiment, one of the members may be shaped as a hook or similar curved member to hook over the PFO for tissue contact from the left atrium, while the other member may be relatively straight for contact with tissue from the right atrium. contact organizations. Thus, tissue can grab together between two parts, bringing them together, unlike an item placed between the two clips of a hair clip or within the arc of a paper clip.

Certain embodiments of the device also include a guide member for advancing through the PFO on which the catheter device is slidably disposed. For example, the guide member may include a guide catheter and at least one expandable member disposed within the guide catheter, wherein the guide catheter is retractable to expose the expandable member, thereby allowing it to expand within the PFO. The expandable member, in turn, may have any suitable configuration, but in certain embodiments it includes at least two members that expand apart to provide lateral force to tissue adjacent the PFO, e.g., a "fish mouth" shape. or bifurcated expandable parts. When exposed, the expandable member can also provide a pulling force on tissue adjacent to the PFO. To provide expandability, the expandable member may be made of a shape memory material, which may be spring loaded and/or the like.

In other alternative embodiments, the guide member may comprise a guide wire having an expandable portion along its length. For example, the expandable portion may be a divided portion comprising an expandable shape memory material. Alternatively, the guide member may include at least one tip configured to contact the left atrial surface of tissue adjacent the PFO. Such an end can conform to the surface of the left atrium. The guide member is retractable to engage at least one distal end with a surface of the left atrium. In any of the embodiments described above, one or more guide members, or components of guide members, may serve as one or more energy transfer members. For example, in some embodiments, an expansion member can be used as a monopolar or bipolar RF electrode.

The at least one energy delivery component of the catheter device may comprise any suitable energy delivery device or combination of devices. For example, the delivery component may deliver radiofrequency energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy, laser energy, or any other form of energy used to treat PFO tissue. In a preferred embodiment, the energy transmission element comprises a monopolar or two bipolar radio frequency transmission elements. For example, such a transport member may be curved to approximate the curvature of the PFO. In other embodiments, straight transport members, mesh or braided transport members, multiple pin-point transport members, etc. may be used.

In certain embodiments, one or more energy delivery components are coupled to one or more tissue attachment components. In some embodiments, for example, one or more energy delivery elements are used as tissue attachment elements. In certain embodiments, the energy delivery member is movable along at least a portion of a circumference of at least one tissue attachment member. In an alternative embodiment, the energy delivery member includes a guide member for advancing through the PFO, wherein the catheter device is slidably disposed on the guide member. Furthermore, the guide member typically includes at least one expandable portion to expand within the PFO to at least partially bring tissue adjacent the PFO together, and in some embodiments the expandable member acts as an energy delivery member. In still other embodiments, an energy delivery member may be coupled to a tissue attachment member and a guide member/expandable member.

As noted above, in one embodiment, the at least one energy transfer member includes one or more energy transfer members disposed within the expandable member to apply energy to a conductive fluid. The energy transfer component also includes one or more conductive fluids that are introduced into the expandable component and then allowed to escape from the expandable component, typically through a plurality of holes. In various embodiments, one, two or more expandable members with porous, conductive fluid and energy transfer portions may be included. In one embodiment, RF energy is delivered to a saline solution as the conducting fluid, but in other varied embodiments, other forms of energy and/or conducting fluids may be used.

Some embodiments of the catheter device may also include at least one sensor coupled to the catheter device for detecting the amount of energy supplied to the tissue by the at least one energy delivery component. For example, the sensor may be an infrared sensor, a thermistor, a thermocouple, etc., but any sensor may be used. Optionally, a microprocessor may be coupled to the at least one sensor to process the sensed data to determine when the energy supplied has reached the desired level of energy.

In another aspect of the invention, a system for treating a patent foramen ovale in the heart includes a catheter device and at least one guide member for guiding the catheter device to a position for treating the patent foramen ovale. The catheter device includes an elongated catheter body having a proximal end and a distal end, at least one tissue attachment member positioned at or near the distal end of the catheter body for at least partially bringing together tissue adjacent to the patent foramen ellipsoid , and at least one energy delivery member located at or adjacent to the distal end for applying energy to tissue to substantially close the patent foramen ellipsoid. The catheter device may include any of the features or variations described above.

These and other embodiments will be described in detail in the following description with reference to the accompanying drawings.

Brief description of the drawings

1 is a schematic diagram of fetal blood circulation;

2 is a schematic diagram of a catheter device according to an embodiment of the present invention, the catheter passes through the internal vena cava and right atrium, and passes through the PFO;

3 is a perspective view of a distal portion of a catheter device having two expandable members according to an embodiment of the present invention;

4 is a perspective view of a distal portion of a catheter device having two expandable members according to another embodiment of the present invention;

5 is a perspective view of a distal portion of a catheter device having an expandable member according to another embodiment of the present invention;

6 is a perspective view of a distal portion of a catheter device having an expandable member and a shape memory member according to another embodiment of the present invention;

7 is a perspective view of a distal portion of a catheter device having two expandable members coupled to two prongs according to another embodiment of the present invention;

8 is a perspective view of a distal portion of a catheter device having an expandable member and two prongs according to another embodiment of the present invention;

9 is a cross-sectional view of a distal portion of a catheter device having two tissue attachment members and a shaped catheter body according to another embodiment of the present invention;

10 is a perspective view of a distal portion of a catheter device having two tissue attachment members and a shaped catheter body according to another embodiment of the present invention;

11A-11C are perspective views of a distal portion of a catheter device illustrating a method of bringing tissue together according to another embodiment of the invention;

12A and 12B are perspective views of a distal portion of a catheter device having two opposing jaws according to another embodiment of the present invention;

13A and 13B are perspective views of a distal portion of a catheter device having two opposing jaws according to another embodiment of the present invention;

14 is a perspective view of a distal portion of a catheter device having a two-pronged tissue attachment member with vacuum in accordance with another embodiment of the present invention;

15A and 15B are perspective views of a distal portion of a catheter device having two opposing jaws and an arcuate member according to another embodiment of the present invention;

16A and 16B are perspective views of a distal portion of a catheter device having a magnetic tissue attachment member according to another embodiment of the present invention;

17 is a perspective view of a distal portion of a catheter device with clamped tissue attachment members according to another embodiment of the present invention;

Figure 18 is a right atrium view of a PFO with a stationary energy delivery component located within the right atrium and a plurality of tissue welds according to another embodiment of the present invention;

19 is a perspective view of a distal portion of a catheter device having two expandable members and a guide wire extending through the right and left atria of the heart according to another embodiment of the present invention; and

20A-20C are perspective views of a distal portion of a catheter device having two separate tissue attachment members according to another embodiment of the present invention.

Detailed ways

The devices and methods of the present invention generally heal a patent foramen ovale (PFO) by applying energy. The method includes advancing a catheter device to a location within the heart to at least partially bring tissue together using the catheter to apply energy to tissue adjacent a PFO, thereby substantially closing the PFO sharply. Devices of the present invention generally include a catheter device having a proximal end and a distal end, at least one tissue attachment member, and at least one energy delivery member adjacent the distal end.

Figure 1 is a schematic diagram of the fetal blood circulation. The figure shows the oval foramen, where an arrow indicates blood flow from the right atrium to the left atrium of the fetus. After a baby is born, if the foramen ellipsoid fails to close (thus, becoming a PFO), blood can flow from the right atrium to the left atrium and vice versa, as described above, leading to sudden loss of brain function, migraines, and other possible adverse health effects increased risk of disease.

Referring to FIG. 2 , an embodiment of a catheter device 10 for treating PFO suitably includes a catheter body 12 and one or more tissue attachment members 14 . Catheter device 10 may be advanced through a patient's vasculature to a location within the heart to treat a PFO. For example, as shown, catheter device 10 is advanced through the vena cava into the right atrium of the heart. In an alternate embodiment, the catheter device may be advanced through the aorta to the left ventricle and then into the left atrium of the heart to treat the PFO. In some embodiments, two separate parts of a catheter device can be advanced into the right and left atrium. In another embodiment, a guide wire or other component of the catheter device can be extended from outside the patient's body through the vasculature. to the right atrium, through the PFO to the left atrium, and through the aorta to the vasculature to exit the patient from a second side. Accordingly, various embodiments may utilize any suitable access technique to place a catheter device within a site to treat a PFO.

Catheter body 12 generally comprises an elongated flexible body having at least one lumen. Catheter body 12 may be fabricated from any suitable material or combination of materials known in the catheter art, as will be disclosed below, eg, PTFE, other polymers, and the like. Catheter body 12 may also have any suitable size, profile, diameter, shape, etc. As shown in FIG. Alternatively, catheter body 12 may be slidably disposed on a guide member (not shown), such as a guide catheter, guide wire, or the like. In certain embodiments, such a guide member may include one or more expansion members or other similar devices for deployment within the PFO to aid in attachment of adjacent tissue. For a further description of such expandable guide members, reference is made to US Patent Application No. 10/679,245, which was incorporated by reference above.

Tissue attachment member 14 may generally include any one, two or more devices to help bring tissue adjacent the PFO together. As shown in FIG. 2, one component 14 may be positioned within the right atrium to access tissue (such as second atrial septal tissue) from the right atrium side, while the other component 14 may be advanced through the PFO to access tissue from the left atrium. In certain embodiments, tissue attachment members 14 may be pre-shaped and fabricated from shape memory materials, spring stainless steel, etc., so that when they are released from catheter body 12, they assume a shape that allows them to gather tissue in Together.

Catheter device 10 also includes at least one energy delivery component. In the illustrated embodiment, one or both tissue attachment members 14 may also serve as energy delivery members. In various embodiments, the energy transfer member is capable of bringing tissue together, the energy transfer member may be coupled to the tissue attachment member, or the energy transfer member may be separate from and not coupled to the tissue attachment member. Also in various embodiments, one energy delivery component may be used to provide monopolar radio frequency (RF), two delivery components may be used to provide bipolar RF energy, or more than two delivery components may be used part.

Referring now to FIG. 3, another embodiment of a catheter device 20 for treating PFO suitably includes a catheter body 22, a first expandable member 27 having a first energy delivery member 23, and a first energy delivery member 27 having a second energy delivery member. The second expandable part 28 of the part 25, such that each expandable part 27, 28 comprises a plurality of holes 24 allowing the passage of the conducting fluid 26. The expandable members 27, 28 can be positioned for treatment in the right atrium (first member 27) and left atrium (second member 28), and then expanded to separate the second interatrial septum SS and the first interatrial septum SP. Tissues and/or other tissues adjacent to the PFO are brought together. In some embodiments, one or both expandable members 27, 28 may also be moved axially along catheter body 22, for example, by sliding to bring tissue together between the two expandable members 27, 28. . For example, the second expandable member 28 may be provided on a separate catheter body disposed on or within the catheter body 22 to allow the second member 28 to slide axially back and forth along the catheter body 22 .

The expandable members 27, 28 may comprise any suitable material or combination of materials now known, or materials developed in the future. Inflatable balloon components for use on catheters are well known and any suitable variant may be used in various embodiments of the invention. The expandable members 27, 28 may be made of a compliant elastomeric material, polymer, etc. and may have any suitable shape after expansion.

Energy can be applied to the tissue by introducing one or more conductive fluids, such as saline solution, into the expandable members 27, 28, and energy (such as RF energy) is applied to the conductive fluids through the energy transmission members 25, 23 26, fluid 26 is then allowed to pass through aperture 24 to contact tissue. Thus, fluid 26 can provide the tissue with the energy needed to cause the PFO to close. After delivering the energy to the tissue near the PFO, the conducted fluid 26 is dissipated harmlessly in the body.

In various embodiments, the energy delivery component may comprise any of a number of devices and may deliver any suitable type of energy to close a PFO. For example, some types of energy that may be employed include radio frequency, cryogenic, resistive heating, ultrasonic, microwave, and laser energy. The radiofrequency energy transmitting element may be monopolar or bipolar, and the monopolar catheter device may also include a grounding element. The energy transfer component may also have any suitable configuration, many of which will be described below with reference to specific embodiments. In certain embodiments, the energy delivery member is fixedly coupled to the tissue attachment member, while in other embodiments the energy delivery member is movable within the tissue attachment member, for example, movable around the circumference of the PFO tissue at multiple PFO tissue is welded at each position. In some embodiments, this can be achieved by circulating a cooled or heated fluid within the expandable members 27 and 28 without allowing such fluid to pass out of the expandable members 27 and 28 . In these embodiments, holes 24 may be eliminated from the design.

The energy delivery components 23, 25 provide sufficient energy delivery for a sufficient time to weld tissue. For example, the energy delivery may span from about 0.5 seconds to about 15 minutes, preferably from about 30 seconds to about 5 minutes. In certain embodiments, power delivery may be from about 0.5 watts to about 100 watts, and preferably, from about 5 watts to about 50 watts. In various embodiments, any other suitable combination of energy and time may also be used. In an experimental example, a PFO within a portion of heart tissue taken from a pig was tested in a flowing saline solution, and fixed by applying suction to the PFO tissue and applying RF energy of about 25 watts for 7 minutes. is closed. RF energy application was then stopped, but tissue attachment was continued for an additional 1 minute to keep the tissue attached while cooling the tissue to allow the collagen within the tissue to reorganize and join together to form a stable tissue bridge. In varying embodiments, other energy application amounts, energy application times, tissue attachment times, etc. may also be used.

Certain embodiments will utilize unipolar or bipolar radio frequency (RF) energy, although any suitable type of energy may be delivered by the energy delivery components in various embodiments. For example, a device may use monopolar RF energy, where energy is applied to all conductive elements simultaneously, cycling through an external ground pad attached to the patient's skin. Alternatively, bipolar energy may be applied to all conducting elements simultaneously, cycling through a ground element housed anywhere on the catheter device. Other embodiments may include applying bipolar energy between two or more energy delivery components that are electrically isolated from each other within the catheter device.

A control system coupled to the energy delivery component or the tissue attachment component, or otherwise disposed within the catheter device, can detect the amount of energy supplied to the PFO tissue and, optionally, upon detection of a change in energy supply conditions, then Energy supply may be automatically stopped, for example, if the resistance or impedance within the PFO tissue or catheter device increases, so does the energy available from the catheter device and/or the like. In some embodiments, when the supplied energy reaches a desired level, such as enough energy to substantially shut down the PFO, the energy supply may be automatically stopped. The supplied energy may be monitored by any suitable method, eg, monitoring temperature or impedance within the PFO tissue, etc. In certain embodiments, one or more sensors coupled to the tissue attachment member, energy delivery member, or any other portion of the catheter device may be used to monitor for such markers. Examples of sensor devices include, but are not limited to, infrared sensors, thermistors, and thermocouples. Optionally, a control system may also include a microprocessor coupled to sensors to determine when the required power has been supplied and/or when to automatically stop power delivery. In alternative embodiments, a microprocessor can be attached to the catheter device which can detect, monitor and control the energy supply, thus, no separate sensor is required.

4 shows a slightly different embodiment of a catheter device 30 having a catheter body 32, a first expandable member 37 and a second expandable member 38 with an energy transmission member 35 and a plurality of allowable A hole 34 through which fluid 36 passes. In this embodiment, the first expandable member 37 can be used as a tissue attachment member without providing additional energy transmission.

Referring to FIG. 5 , another embodiment of a catheter device 40 for treating PFO includes a catheter body 42 , an expandable member 48 having a plurality of holes 44 to allow passage of fluid 46 , and an energy delivery member 45 . In this embodiment, expansion of the expandable member 48 may be sufficient to bring the tissue together, or a proximally directed force may be applied to the expandable member 48, for example, by pulling back on the catheter body 42 to bring the tissue together. Together.

Referring now to FIG. 6, an embodiment of a catheter device 50 includes a catheter body 52, an expandable member 57 having an energy transfer member 53 disposed therein and means on its surface for passage of a conductive fluid 56. Aperture 54, and a shaped distal portion 59. The shaped distal portion 59 resides within the left atrium and acts as a surface or "stop" such that tissue can be brought together between the shaped distal portion 59 and the expandable member 57 . In the illustrated embodiment, the shaped distal portion 59 is a helical coil, which may be made of shape memory material, spring stainless steel, etc., so that it has a relatively straight configuration, but assumes a coiled configuration when released. In other embodiments, other backstop arrangements may be used, such as that described more fully in US Patent Application No. 60/478,035, which was incorporated by reference above.

7 shows another embodiment of a catheter device 60 comprising a catheter body 62, a bifurcated tissue attachment member 64, and two expandable members coupled to the two prongs 64 to provide further tissue attachment. 66. The prongs of the tissue attachment member 64 may comprise Nitinol, some other shape memory material, etc. The tissue attachment member 64 is normally released from the catheter body 62 within a PFO allowing the prongs 64 to expand. The tissue between the prongs is thus brought together and essentially flattened or "fish mouthed". To further attach tissue, expandable member 66 can be expanded, and optionally proximal force can be applied, such as by pulling back onto catheter body 62, with expandable member 66 pushing the tissue together. The prongs 64 then serve as energy delivery components to apply energy to the tissue. Typically, the prongs 64 are bipolar RF energy transmitting components, although alternative embodiments are contemplated.

In an alternative embodiment, referring now to FIG. 8, a catheter device 70 may include a catheter body 72, a bifurcated tissue attachment member 74, and a separate expandable member 76 for enhancing tissue attachment. Furthermore, tissue attachment member 74 may also serve as an energy delivery member. Additionally or alternatively, a plurality of holes may be provided in the expandable member 76 for introducing conductive fluid as part of the energy supply system.

Referring now to FIG. 9 , in another embodiment, a catheter device 80 suitably includes a catheter body 86 , a first tissue attachment member 82 and a second tissue attachment member 84 . As noted above, one or both tissue attachment members 82, 84 may be coupled to or may serve as energy delivery members. In this embodiment, the first tissue attachment member 82 is configured to contact tissue from the right atrium (such as the second interatrial septum SS), and the second tissue attachment member 84 is configured to contact tissue from the left atrium (such as the first interatrial septum SP). . In contacting and bringing the tissue together (hollow-ended arrows), the tissue attachment members 82, 84 also engage (or compress) the tissue together against the catheter body 86 . When force is applied to catheter body 86, due to its cross-sectional shape, it is pushed to one side (solid-ended arrow). In the illustrated embodiment, catheter body 86 has a triangular cross-section, but in alternative embodiments, it may have other shapes, such as oval, ellipsoid, diamond, and the like. When the catheter body 86 is pushed sideways, the tissue attachment/energy delivery components 82, 84 are used to apply energy to tissue at the first location. The tissue attachment members 82, 84 can then be moved sideways toward the catheter body 86 to bring adjacent tissue together, thereby pushing the catheter body 86 further along the PFO. Energy can then be reapplied to the tissue at the second location. Using such a technique, the catheter device 80 can be moved across a PFO from side to side, applying energy and closing the PFO as the device 80 moves. In other words, the catheter device "walks" along the PFO, followed by tissue spot welding.

Figure 10 is an embodiment of a catheter device 90 that may be used in a method similar to that just described. Device 90 includes a catheter body 92 , a first tissue attachment member 94 , and a second tissue attachment member 96 and is shown disposed over a guide wire 98 . In this embodiment, the tissue attachment members 94, 96 also serve as energy delivery members. The first tissue attachment member 94 is a spring loaded jaw and the second tissue attachment member 96 is a shape memory energy delivery member, eg, an electrode. As described above, when tissue attachment members 94, 96 bring together tissue adjacent the PFO, they bring the tissue together against catheter body 92, thereby squeezing catheter body 92 aside. After applying energy to the tissue, the tissue attachment members 94, 96 can then be moved again toward the catheter body 92 and used to bring the tissue together again, thereby squeezing the catheter body 92 out of the way again. To facilitate such a technique, catheter body 92 may include one or more smooth surfaces to allow it to slide sideways more easily. Catheter body 92 may also include a coating, bond, etc. of a tissue welding substance, such as albumin that is partially wiped off the catheter body each time it is squeezed to the side, thereby increasing the applied energy to the tissue to close the PFO. Catheter body 92 may also include one or more holes for directing fluid at the site of energy application, for use as a welding fluid, or to otherwise enhance tissue welding.

In the embodiment shown in FIGS. 9 and 10, as well as other embodiments, a catheter device may also include a biasing member for biasing the catheter device toward the side of the PFO to initiate a PFO closure procedure. For example, an expandable member may be coupled to a catheter body, usually on one side of the catheter body, so that when the catheter device is positioned within the PFO and the expandable member is expanded, the catheter device is pushed against one side of the PFO. side. The tissue can then be brought together and welded on that side, and the expandable member can be tapered to allow the catheter device to move towards the other side of the PFO, bringing the tissue together and applying energy as it moves . A similar result can be achieved with an offset wire, a catheter body having an offset shape, and the like.

Referring now to FIGS. 11A-11C , in another embodiment, a catheter device 100 for treating PFO includes a catheter body 106 , a first tissue attachment member 104 and a second tissue attachment member 102 . The tissue attachment members 102, 104 include energy delivery members of shape memory material made from Nitinol or any other suitable shape memory material. To deploy the tissue-attachment members 102, 104, the catheter body 106 is first advanced through the PFO (as shown in FIG. 11A). Catheter body 106 is then withdrawn/retracted while second tissue attachment member 102 is advanced (solid-tipped arrow) to release second tissue attachment member 102 from the distal end of catheter body 106 . As shown in FIG. 11B , the catheter body 106 can then be advanced again to push against a surface of the second tissue attachment member 102, thereby opening the attachment member (solid-ended arrow) to engage tissue adjacent the PFO (such as the first atrial septum) superior. The technique is similar to spreading the two prongs of a hairpin. As shown in FIG. 11C , after placing the second tissue attachment member 102 in contact with the first interatrial septum, the catheter body 106 can be retracted again and the first tissue attachment member 104 can be advanced to expose the first member 104 . The tissues are then brought together between the two tissue attachment members 102, 104, and the tissue attachment members 102, 104 are used to apply energy to the tissue to close the PFO.

12A and 12B illustrate another embodiment of a catheter device 110 for treating a PFO, which includes a catheter body and a pair of opposing jaws 114 . Jaws 114 may be used to grasp tissue adjacent to the PFO, such as tissue of the second interatrial septum SS and first interatrial septum SP, to bring them together for energy application and tissue welding. The jaw 114 may also include energy delivery components, eg, two electrodes for a bipolar RF device, one electrode and an energy return component for a monopolar RF device, and the like. In certain embodiments, one or both jaws 114 may be advanced through (or in other words penetrate) the PFO tissue. Here, one clamp is advanced into the first interatrial septum SP as indicated by the dashed line. Figure 12A shows the jaws 114 expanded, while Figure 12B shows the jaws 114 drawn back together, drawing the tissue together.

Referring to Figures 13A and 13B, catheter device 110 is shown with two jaws 114 penetrating tissue adjacent the PFO. Again, the jaws 114 are open in Figure 13A and pulled back together in Figure 13B to draw the tissue together.

Referring now to Figure 14, in one embodiment, a catheter device 120 for treating PFO suitably includes a catheter body 122 and a bifurcated "fish mouth" shaped tissue attachment member 124 having a plurality of vacuum holes 126 for Vacuum force is applied to improve tissue attachment. As described above, the tissue attachment prongs 124 can be deployed within the PFO to bring the tissue together, and the vacuum holes 126 can then be used to further attach the tissue. Energy may then be applied through the tissue attachment prongs 124, which in one embodiment may include bipolar RF energy delivery components.

Referring to FIGS. 15A and 15B , another embodiment of a catheter device 130 suitably includes a catheter body 132 , a gripping tissue attachment member 134 , and a shape memory tissue attachment member 136 . These tissue attachment members 134, 136 can be used to access tissue from the right and left atrial sides of the PFO (as shown in Figure 15A) and then used to bring the tissue together (as shown in Figure 15B). One or both tissue attachment members 134, 136 may also serve as energy delivery members.

In FIGS. 16A and 16B , a catheter device 140 includes a catheter body 142 , a positively charged magnet 144 and a negatively charged magnet 146 . The magnets 144, 146 serve dual roles as tissue attachment members and energy delivery members, as shown in Figure 16B, bringing tissue together between them due to the opposing polarities of the magnets.

In another embodiment, as shown in FIG. 17, the tissue attachment component 150 of a catheter device for treating a PFO may include a clamp that includes a clip for positioning in the right atrium, as seen from a perspective view within the right atrium. A first clamp arm 152 and a second clamp arm 154 are positioned within the left atrium. The two arms 152, 154 are then brought together to bring the tissue together.

In FIG. 18 , again from a perspective view within the right atrium, only one electrode 162 is shown. In one embodiment of the device, a relatively large electrode 162 can be positioned within the right atrium and remain in approximately the same position throughout the procedure. A smaller electrode can then be placed in the left atrium and moved along the tissue of the PFO to form a tissue spot weld 164 to close the PFO. Pressure and bipolar RF energy are directed between the smaller and larger electrodes 162 to bring tissue together and apply energy to close the PFO.

Referring now to FIG. 19, in another embodiment, a catheter system 170 for treating PFO may include a first catheter body 172 having a first expandable member 176, a first catheter body 172 having a second expandable member 178. The second catheter body 174, and a guide wire 179. In one embodiment, the guide wire extends from an entry point in the patient, such as a common vein, through the internal vena cava IVC, right atrium RA, PFO, and left atrium LA, then through the left ventricle, the aorta, and finally through the exit femoral artery. Catheter bodies 172, 174 can be advanced along the guidewire to sites within the right and left atria, respectively. In an alternate embodiment, two guidewires may be used, which may be coupled within the PFO or somewhere within the heart.

In another embodiment, as shown in FIGS. 20A-20C , a catheter device 180 includes a catheter body 182 , a left atrial tissue attachment member 184 and a separate right atrial tissue attachment member 186 . Figure 20A shows catheter body 182 and left atrial component 184 from a right atrium view with left atrial component 184 hooked on the PFO into the left atrium. Figure 20B is a detail view taken from a perspective view of the distal end of the left atrial component 184 hooked into the left atrium. Figure 20C shows the left atrial component 184 and right atrial component 186 in place for attachment of the tissue of the PFO. In one embodiment, the left atrial component 184 can be rotated (arc arrow) to move the hooked portion along the left atrium of the PFO to apply energy at multiple locations.

While the foregoing description is complete and precise, it describes only a few exemplary embodiments of the invention. Various changes, additions, omissions, etc. may be made to one or more embodiments of the present invention without departing from the scope of the present invention. Furthermore, different elements of the present invention may be combined to achieve any of the above-mentioned effects. Accordingly, the above description is provided for the purpose of illustration only and should not be construed as limiting the scope of the invention as set forth in the appended claims.

Claims (136)

1. A method for treating patent foramen ellipsoid in the heart, the method comprising: Advancing a catheter device to a location within the heart to treat a patent foramen ellipsoid; using a catheter device to at least partially bring together tissue adjacent to the patent foramen ovale; and Energy is applied to the tissue with the catheter device, essentially closing the patent foramen ovale sharply. 2. The method of claim 1, wherein the tissue is brought together prior to applying the energy. 3. The method of claim 2, further comprising holding the tissue together while applying energy. 4. The method of claim 3, further comprising holding the tissues together to allow them to cool after applying the energy. 5. The method of claim 4, further comprising: moving at least part of the catheter device to a different position relative to the tissue; bring the organization together again at least in part; and Apply energy to the tissue again. 6. The method of claim 5, further comprising the steps of repeatedly moving, bringing tissue together, and applying energy at a plurality of locations along the patent foramen ovale. 7. The method of claim 6, wherein the steps of repeatedly moving, bringing tissue together, and applying energy begin on the first side of the patent foramen ellipsoid and continue across the patent foramen ellipsoid to the second side. side. 8. The method of claim 7, further comprising biasing at least a portion of the catheter device toward the first side using a biasing device on the catheter prior to first bringing the tissue together. 9. The method of claim 7, wherein moving at least part of the catheter body comprises: bringing tissue together between two energy delivery components, wherein the tissue is brought together against a catheter body of the catheter device , wherein bringing the tissue together against the catheter body pushes the catheter body to a different position. 10. The method of claim 7, wherein moving at least a portion of the catheter device comprises moving at least one energy delivery component to a different position. 11. The method of claim 10, wherein moving at least part of the catheter device comprises moving the two energy delivery components to different positions. 12. The method of claim 11, wherein moving at least a portion of the catheter device further comprises moving a catheter body to a different position. 13. The method of claim 4, further comprising effectively cooling the tissue after applying the energy. 14. The method of claim 1, wherein advancing the catheter comprises positioning the first distal portion of the catheter within the right atrium of the heart. 15. The method of claim 14, wherein advancing the catheter further comprises passing a second distal portion of the advancing catheter at least partially through the patent foramen ellipsoid. 16. The method of claim 15, further comprising advancing the second distal portion through the patent foramen ellipsoid into the left ventricle. 17. The method of claim 15, further comprising retracting a catheter body or sheath to expose at least the second distal portion. 18. The method of claim 15, wherein at least partially bringing the tissue together comprises applying force to the tissue by manipulating at least one of the first and second distal portions. 19. The method of claim 18, wherein bringing the tissues together comprises: manipulating one of the first and second distal portions to apply force to the tissue; and The other of the first and second distal end portions is maintained in a relatively stable position to serve as an abutable surface to bring tissue together. 20. The method of claim 18, wherein bringing the tissue together comprises moving the first and second distal end portions toward each other to bring the tissue therebetween. 21. The method of claim 18, wherein bringing the tissue together comprises expanding at least one expandable member on at least one of the first and second distal portions. 22. The method of claim 21, wherein bringing the tissues together comprises: expanding a first expandable member on the first distal portion; and A second expandable member is expanded on the second distal portion. 23. The method of claim 22, further comprising axially moving at least one of the first and second expandable members along the catheter device toward the other expandable member to bring tissue together between them. 24. The method of claim 18, wherein manipulating at least one of the first and second distal portions comprises advancing at least one portion into one of the tissues adjacent to the patent foramen ellipsoid. 25. The method of claim 24, wherein the first distal portion is advanced into the second interatrial septal tissue. 26. The method of claim 25, wherein the second distal portion is advanced into the first interatrial septal tissue, wherein the first and second distal portions come together to bring the tissue together. 27. The method of claim 16, wherein bringing the tissue together comprises applying a magnetic attraction between the first and second distal portions. 28. The method of claim 1, wherein advancing the catheter comprises passing an expandable distal portion of the advancing catheter at least partially through the patent foramen ellipsoid, the expandable distal portion being disposed within a sheath . 29. The method of claim 28, wherein bringing the tissue together comprises: retracting the sheath to expose the inflatable distal portion, thereby allowing it to expand to place the tissue in the portions of the inflatable member grouped together. 30. The method of claim 1, wherein applying energy comprises applying at least one of the following: radio frequency energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy, and laser energy. 31. The method of claim 30, wherein at least one of monopolar radiofrequency energy and bipolar radiofrequency energy is applied. 32. The method of claim 30, wherein applying energy comprises energizing a single conductive member of the catheter device 33. The method of claim 30, wherein applying energy comprises energizing a plurality of conductive members of the catheter device. 34. The method of claim 30, wherein applying energy comprises: energizing at least one conductive fluid within the catheter device; and The conducted fluid is released from within the catheter device to contact tissue. 35. The method of claim 34, wherein energizing the conductive fluid comprises applying radio frequency energy to the fluid disposed within at least one expandable component of the catheter device. 36. The method of claim 35, wherein the fluid comprises saline solution. 37. The method of claim 35, wherein releasing the conducted fluid comprises allowing the fluid to flow out of at least one aperture located in at least one expandable member. 38. The method of claim 37, further comprising directing fluid into the expandable member. 39. The method of claim 1, wherein applying energy comprises modifying collagen within the tissue. 40. The method of claim 1, further comprising monitoring the amount of energy applied to the tissue. 41. The method of claim 40, wherein monitoring the magnitude of the energy comprises monitoring the temperature of the tissue. 42. The method of claim 40, wherein monitoring the magnitude of the energy comprises monitoring the impedance of the tissue. 43. The method of claim 40, further comprising determining when sufficient energy has been applied to the tissue to substantially abruptly close the patent foramen ellipsoid. 44. The method of claim 43, further comprising ceasing the application of energy when sufficient energy has been applied. 45. The method of claim 1, further comprising directly viewing the patent foramen ellipsoid and tissue with at least one visualization device coupled to the catheter device. 46. A method of treating a patent foramen ellipsoid in the heart, the method comprising: Advancing a catheter device to a location within the heart to treat a patent foramen ellipsoid; using a catheter device to at least partially bring together tissue adjacent to the patent foramen ovale; applying energy to tissue with the catheter device while at least partially holding the tissue together; and The tissue is at least partially held together after application of the energy for a sufficient time to substantially close the patent foramen ellipsoid. 47. A catheter device for treating a patent foramen ellipsoid in the heart, the catheter device comprising: an elongated catheter body having a proximal end and a distal end; at least one tissue attachment member positioned at or near the distal end of the catheter body to at least partially bring together tissue adjacent to the patent foramen ovale; and At least one energy delivery member is located at or near the distal end for applying energy to tissue to substantially abruptly close the patent foramen ellipsoid. 48. The catheter device of claim 47, wherein the at least one tissue attachment member comprises at least a first tissue attachment member to access tissue adjacent the patent foramen ellipsoid from the right atrium of the heart. 49. The catheter device of claim 48, wherein at least one tissue attachment member further comprises at least a second tissue attachment member for accessing tissue adjacent the patent foramen ellipsoid from the right atrium. 50. The catheter device of claim 49, wherein the first and second tissue attachment members comprise opposing jaws, wherein at least one of the first and second members is advanceable through adjacent patent foramen ovale organization. 51. The catheter device of claim 50, wherein the first attachment member is advanced through the second atrial septal tissue and the second attachment member is advanced through the first atrial septal tissue. 52. The catheter device of claim 48, wherein at least one tissue attachment member further comprises at least a second tissue attachment portion for advancement through the patent foramen ellipsoid to access tissue from the left atrium of the heart. 53. The catheter device of claim 52, wherein at least one of the first and second tissue attachment members comprises an expandable member. 54. The catheter device of claim 53, wherein both the first and second tissue attachment members comprise expandable members, wherein at least one expandable portion is slidably disposed along the catheter body so as to be axially to move towards the other expandable member. 55. The catheter device of claim 53, wherein at least one expandable member includes at least one aperture for releasing conductive fluid to contact tissue. 56. The catheter device of claim 55, wherein at least one expandable member includes a plurality of apertures for releasing the conductive fluid. 57. The catheter device of claim 55, wherein one of the first and second members includes an expandable member and the other of the first and second members includes an expandable shaped portion, Therein, an expandable member and a shaping portion are brought together to bring tissue together. 58. The catheter device of claim 57, wherein the expandable shaped portion comprises a shape memory material that changes from an undeployed shape to a deployed shape when released from the catheter body. 59. The catheter device of claim 52, wherein the first and second tissue attachment members comprise a clamp for clamping the tissue together. 60. The catheter device of claim 52, wherein the first tissue-attachment member has a first expanded shape and the second tissue-attachment member has a second expanded shape, wherein when expanded into contact with tissue, The first and second components bring the tissues together. 61. The catheter device of claim 60, wherein the first shape generally comprises a curved hook for bending over the edge of the patent foramen ovale to apply force to tissue from the left atrium, wherein the first shape The second shape generally includes a rectilinear shape to apply pressure to tissue from the right atrium. 62. The catheter device of claim 52, wherein the first and second tissue attachment members comprise magnets having opposite polarities. 63. The catheter device of claim 52, wherein the first tissue attachment member includes a pair of opposing jaws for accessing the second interatrial septum from the right atrium, and the second tissue attachment member includes an arcuate member , so as to advance through the patent foramen ellipse to access the first interatrial septum from the left atrium. 64. The catheter device of claim 47, wherein at least one tissue attachment component comprises: at least two tissue attachment members for moving relative to each other to collect tissue therebetween; and At least one biasing member for biasing the tissue attachment member toward the first side of the patent foramen ovale. 65. The catheter device of claim 64, wherein the tissue attachment member is movable along the patent foramen ovale from a first side of the patent foramen ovale to an opposite second side. 66. The catheter device of claim 65, wherein the catheter body has a cross-sectional shape such that when tissue is brought together between the two tissue attachment members, the tissue pushes the catheter body relative to the patent foramen ellipsoid. different locations. 67. The catheter device of claim 66, wherein the shape is selected from the group consisting of triangular, oval, oval, and diamond. 68. The catheter device of claim 66, wherein the two tissue attachment members comprise: a shape memory tissue attachment component; and A jaw part. 69. The catheter device of claim 66, further comprising at least one aperture in the catheter body for releasing one or more fluids to enhance application of energy to tissue to close the patent foramen ovale. 70. The catheter device of claim 66, further comprising a coating on the catheter body that enhances the application of energy to the tissue when the tissue contacts the catheter body. 71. The catheter device of claim 47, wherein at least one tissue attachment member comprises an expandable member releasably disposed within the catheter body, wherein advancing the expandable member protrudes from the distal end of the catheter body, or relatively The catheter body is retracted from the expandable member to allow the expandable member to expand within the patent foramen ovale. 72. The catheter device of claim 71, wherein the expandable member includes two prongs that expand to provide a lateral force against tissue adjacent the patent foramen ovale. 73. The catheter device of claim 72, wherein the prongs do not extend into the left atrium of the heart. 74. The catheter device of claim 72, wherein the prongs are spring loaded. 75. The catheter device of claim 72, wherein the prongs comprise a shape memory material. 76. The catheter device of claim 72, wherein the prongs include at least one vacuum hole for applying a vacuum force to further bring the tissue together. 77. The catheter device of claim 47, further comprising a guide member for advancement through the patent foramen ovale, wherein the catheter device is slidably disposed on the guide member. 78. The catheter device of claim 77, wherein the guide member comprises a guide wire divided along a portion of its length, the divided portion comprising expandable shape memory material. 79. The catheter device of claim 77, wherein the guide member includes at least one tip for contacting the left atrial surface of tissue adjacent the patent foramen ellipsoid. 80. The catheter device of claim 79, wherein at least one tip is conformable to the surface of the left atrium. 81. The catheter device of claim 79, wherein the guide member is retractable to engage at least one distal end with a surface of the left atrium. 82. The catheter device of claim 77, wherein the guiding member comprises at least one energy transmitting member. 83. The catheter device of claim 82, wherein the guide member includes an expandable member for expansion within the patent foramen ovale, and wherein the expandable member includes at least one radio frequency energy transmitting member. 84. The catheter device of claim 47, wherein at least one energy transmitting component transmits at least one of the following energy: radiofrequency energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy, and laser energy. 85. The catheter device of claim 84, wherein at least one energy delivery member is movable relative to at least one tissue attachment member. 86. The catheter device of claim 84, wherein at least one energy delivery member is coupled to at least one tissue attachment member. 87. The catheter device of claim 84, wherein at least one energy delivery member comprises the at least one tissue attachment member. 88. The catheter device of claim 84, wherein the at least one energy transmitting component comprises at least one monopolar radiofrequency transmitting component. 89. The catheter device of claim 84, wherein the at least one energy transmitting element comprises at least two bipolar radiofrequency transmitting elements. 90. The catheter device of claim 84, wherein at least one energy delivery component comprises: at least one radiofrequency transmitting component disposed within an expandable component including at least one aperture for releasing fluid into contact with tissue; and At least one conductive fluid is disposed within the expandable member and exposed to the radiofrequency transmitting member. 91. The catheter device of claim 84, wherein the at least one energy transmitting element comprises at least one arcuate radiofrequency transmitting element. 92. The catheter device of claim 84, wherein at least one energy transmission component comprises at least one of a mesh material and a braided material. 93. The catheter device of claim 47, wherein at least one energy delivery member includes a guide member for advancement through the patent foramen ovale. 94. The catheter device of claim 93, wherein the guide member includes at least one expandable portion to expand within the patent foramen ovale to at least partially bring together tissue adjacent to the patent foramen ovale . 95. The catheter device of claim 47, further comprising at least one sensor coupled to the catheter device to detect energy supplied to the tissue by the at least one energy delivery component. 96. The catheter device of claim 95, wherein at least one sensor is selected from the group consisting of: an infrared sensor, a thermistor, and a thermocouple. 97. The catheter device of claim 95, further comprising a microprocessor coupled to at least one sensor to process detected data to determine when the energy supplied has reached the desired energy. 98. The catheter device of claim 47, further comprising a microprocessor coupled to the catheter device for monitoring and controlling energy delivered by the energy delivery member. 99. A system for treating a patent foramen ellipsoid in the heart, the system comprising: A catheter set comprising: an elongated catheter body having a proximal end and a distal end; at least one tissue attachment member positioned at or near the distal end of the catheter body to at least partially bring together tissue adjacent the patent foramen ovale; and at least one energy delivery member located at or near the distal end to apply energy to tissue to substantially close the patent foramen ellipsoid; and At least one guide member for guiding the catheter device to a position for treating the patent foramen ovale. 100. The system of claim 99, wherein the at least one tissue attachment member comprises at least a first tissue attachment member for accessing tissue adjacent the patent foramen ellipsoid from the right atrium of the heart. 101. The system of claim 100, wherein at least one tissue attachment member further comprises at least a second tissue attachment portion for accessing tissue adjacent the patent foramen ellipsoid from the right atrium. 102. The system of claim 101 , wherein the first and second tissue attachment members comprise opposing jaws, wherein at least one of the first and second members is advanceable through an opening adjacent to the patent foramen ovale. organize. 103. The system of claim 102, wherein the first attachment member is advanced through the second atrial septal tissue and the second attachment member is advanced through the first atrial septal tissue. 104. The system of claim 100, wherein at least one tissue attachment member further comprises at least a second tissue attachment portion for contacting tissue adjacent the patent foramen ellipsoid from the left atrium of the heart. 105. The system of claim 104, wherein the second tissue attachment member is advanced through the patent foramen ellipsoid into the left atrium to contact tissue. 106. The system of claim 105, wherein at least one of the first and second tissue attachment members comprises an expandable member. 107. The system of claim 106, wherein both the first and second tissue attachment members comprise expandable members, wherein at least one of the expandable members is slidably disposed along the catheter body so that Axially movable towards the other expandable member. 108. The system of claim 106, wherein at least one expandable member includes at least one aperture for releasing the conducted fluid into contact with the tissue. 109. The system of claim 108, wherein at least one expandable member includes a plurality of apertures for releasing the conducted fluid. 110. The system of claim 108, wherein one of the first and second members comprises an expandable member and the other of the first and second members comprises an expandable forming portion, wherein, The expandable member and the shaped portion come together to hold the tissue together. 111. The system of claim 110, wherein the expandable shaped portion comprises a shape memory material that changes from an undeployed shape to a deployed shape when released from the catheter body. 112. The system of claim 104, wherein the first and second tissue attachment members comprise a clamp for clamping the tissue together. 113. The system of claim 99, wherein at least one tissue attachment component comprises: at least two tissue attachment members for movement relative to each other to collect tissue therebetween; and At least one biasing member for biasing the tissue attachment member toward the first side of the patent foramen ovale. 114. The system of claim 113, wherein the tissue attachment member is movable along the patent foramen ovale from the first side to the opposite side of the patent foramen ovale. 115. The system of claim 99, wherein at least one tissue attachment member comprises an expandable member releasably disposed within the catheter body, wherein advancing the expandable member protrudes from the distal end of the catheter body to allow The expandable member expands within the patent foramen oval. 116. The system of claim 115, wherein the expandable member comprises at least two members that expand to provide a lateral force on tissue adjacent the patent foramen ovale. 117. The system of claim 116, wherein the exposed expansion member provides the lateral force without extending into the left atrium of the heart. 118. The system of claim 116, wherein the expandable member comprises a spring loaded member. 119. The system of claim 116, wherein the expandable member comprises a shape memory material. 120. The system of claim 99, wherein the guide member is advanced through the patent foramen ovale, and wherein the catheter device is slidably disposed on the guide member. 121. The system of claim 120, wherein the guide member comprises a guide wire divided along a portion of its length, the divided portion comprising expandable shape memory material. 122. The system of claim 121, wherein the guide member includes at least one tip for contacting the left atrial surface of tissue adjacent to the patent foramen ellipsoid. 123. The system of claim 122, wherein at least one end conforms to the surface of the left atrium. 124. The system of claim 122, wherein the guide member is retractable to engage at least one distal end with a surface of the left atrium. 125. The system of claim 99, wherein at least one energy delivery component transmits at least one of the following energies: radio frequency energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy, and laser energy. 126. The system of claim 125, wherein at least one energy delivery member is movable relative to at least one tissue attachment member. 127. The system of claim 125, wherein at least one energy delivery component is coupled to at least one tissue attachment component. 128. The system of claim 127, wherein the at least one energy delivery component comprises at least one monopolar radio frequency delivery component. 129. The system of claim 127, wherein the at least one energy delivery component comprises at least two bipolar radio frequency delivery components. 130. The system of claim 127, wherein at least one energy delivery component comprises: at least one radio frequency transmitting component disposed within an expandable component including at least one aperture for releasing fluid into contact with tissue; and At least one conductive fluid is disposed within the expandable member and exposed to the radio frequency transmitting member. 131. The system of claim 127, wherein the at least one energy transmitting element comprises at least one arcuate radio frequency transmitting element. 132. The system of claim 127, wherein at least one energy transfer component comprises at least one of a mesh material and a braided material. 133. The system of claim 99, further comprising at least one sensor coupled to the catheter device to detect energy supplied to the tissue by the at least one energy delivery component. 134. The system of claim 133, wherein at least one sensor is selected from the group consisting of: an infrared sensor, a thermistor, and a thermocouple. 135. The system of claim 133, further comprising a microprocessor coupled to at least one sensor to process detected data to determine when the supplied energy has reached the required energy. 136. The system of claim 99, further comprising a microprocessor coupled to the catheter device for monitoring and controlling energy delivered by the energy delivery member.

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