US20040117032A1 - Devices for less-invasive intracardiac interventions - Google Patents

Abstract

Devices, systems, and methods are provided for accessing the interior of the heart and performing procedures therein while the heart is beating. In one embodiment, a tubular access device having an inner lumen is provided for positioning through a penetration in a muscular wall of the heart, the access device having a means for sealing within the penetration to inhibit leakage of blood through the penetration. The sealing means may comprise a balloon or flange on the access device, or a suture placed in the heart wall to gather the heart tissue against the access device. An obturator is removably positionable in the inner lumen of the access device, the obturator having a cutting means at its distal end for penetrating the muscular wall of the heart. The access device is preferably positioned through an intercostal space and through the muscular wall of the heart. Elongated instruments may be introduced through the tubular access device into an interior chamber of the heart to perform procedures such as septal defect repair and electrophysiological mapping and ablation. A method of septal defect repair includes positioning a tubular access device percutaneously through an intercostal space and through a penetration in a muscular wall of the heart, passing one or more instruments through an inner lumen of the tubular access device into an interior chamber of the heart, and using the instruments to close the septal defect. Devices and methods for closing the septal defect with either sutures or with patch-type devices are disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is continuation-in-part of copending application Ser. No. 08/425,179, filed Apr. 20, 1995, which is a continuation-in-part of application Ser. No. 08/163,241, filed Dec. 6, 1993, which is a continuation in part of application Ser. No. 08/023,778, filed Feb. 22, 1993. The complete disclosures of all of these applications are hereby incorporated herein by reference for all purposes.[0001]
FIELD OF THE INVENTION
• The present invention relates generally to less-invasive surgery of the cardiovascular system. More specifically, the invention relates to thoracoscopic devices and techniques for performing surgical procedures within the heart and great vessels while the heart is beating.[0002]
BACKGROUND OF THE INVENTION
• Tens of thousands of people are born each year with congenital defects of the heart. Some of the more common types of congenital cardiac defects include atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosis (PDA). An ASD is a hole in the cardiac septum between the left and right atria, while a VSD is a hole in the septum between the left and right ventricles. Patent ductus arteriosis is incomplete closure of the opening between the pulmonary artery and the aorta that is present during fetal development. These conditions may cause blood to abnormally shunt from the right side of the heart to the left side of the heart without being properly oxygenated in the lungs, so that the body tissues supplied by the blood are deprived of oxygen. In addition, blood in the left side of the heart may shunt back to the right side through the defect rather than being pumped into the arterial system, causing abnormal enlargement of the right chambers of the heart.[0003]
• ASD's, VSD's and PDA can frequently be surgically repaired with significant success. Smaller defects may be reparable by simply suturing the defect closed, while larger defects may require a patch of polyester, expanded polytetrafluoroethylene, or a portion of the patient's own pericardium to be sutured into the heart to cover and occlude the defect.[0004]
• Ordinarily, such surgery is performed using open-chest techniques while the heart is under cardioplegic arrest and circulation is maintained by cardiopulmonary bypass. Using such techniques, a gross thoracotomy is created in order to gain access to the heart and great vessels, facilitating clamping and cannulation of the aorta for inducing cardioplegic arrest, and allowing instruments to be introduced into the chest cavity and into the heart to perform the surgical repair. The necessity of stopping the heart significantly heightens the risks attendant such procedures, particularly the risks of causing ischemic damage to the heart muscle, and of causing stroke or other injury due to circulatory emboli produced by aortic clamping and vascular cannulation. In addition, the creation of a gross thoracotomy produces significant morbidity and mortality, lengthens hospital stay and subsequent recovery, increases costs, and worsens the pain and trauma suffered by the patient. Moreover, many congenital defects are repaired in children under the age of ten years for whom the morbidity and mortality of open-chest surgery and cardioplegic arrest can be even greater than for older patients.[0005]
• In an effort to avoid the necessity of grossly opening the chest and stopping the heart, a number of intravascular devices have been developed for repair of ASD's, VSD's, and PDA. For example, U.S. Pat. No. 3,874,388 to King et al. discloses an intravascular delivery catheter introduced intraluminally from a peripheral vein into the right side of the heart which can be used to position an artificial umbrella-like patch across a septal defect and to anchor the patch to the cardiac septum. Other intravascular delivery devices and artificial patches for the repair of septal defects can be seen in U.S. Pat. No. 5,334,217, U.S. Pat. No. 5,284,488, U.S. Pat. No. 4,917,089, U.S. Pat. No. 4,007,743, and PCT Application No. PCT/US92/10141.[0006]
• While intravascular approaches to the repair of congenital defects may provide certain advantages, the most significant of which is the elimination of the need for gross thoracotomy and cardioplegic arrest, these techniques have suffered from a number of problems. One such problem is the difficulty in manipulating the artificial patches into position across a defect using only the proximal end of a long and flexible delivery catheter positioned through a tortuous arterial or venous lumen. Also problematic is the inadequacy of fixation of endovascularly-placed patches, creating a tendency of such patches to migrate or embolize after placement, which can allow blood to again shunt through the defect. In addition, once such a patch has been placed and the delivery catheter detached from the patch, relocating and repositioning the patch with the catheter is difficult, if not impossible, and may require open surgical correction. Moreover, in young children, the size of the peripheral vessels is extremely small, and damage to such vessels could have serious effects upon the growth of the child. Thus, the size of the devices which can be introduced through such vessels is greatly limited.[0007]
• In addition to ASD, VSD, and PDA, various other types of cardiac disease also may be diagnosed and treated by intervention within the interior chambers of the heart. For example, some cardiac arrhythmias such as ventricular tachycardias, supraventricular tachycardias, and atrial fibrillation, may be diagnosed by obtaining access into an interior chamber of the heart and by performing electrophysiological mapping to identify abnormal conduction pathways. Once these abnormal conduction pathways are identified, in some cases the disease may be treated by ablating selected cardiac tissue using radiofrequency (RF) energy or a medical laser to eliminate the abnormal pathways. A number of endovascular approaches have been developed which attempt to allow intracardiac mapping and ablation using catheters introduced transluminally from peripheral vessels into the heart. Such devices are disclosed, for example, in U.S. Pat. Nos. 4,960,134, 4,573,473, 4,628,937, and 5,327,889. However, endovascular mapping and ablation devices suffer from many of the same problems suffered by endovascular septal defect repair devices, including a lack of control and precise positionability from the proximal end of these highly flexible and elongated devices, the significant size constraints of peripheral vessels, and the inability to position the devices in all potentially diseased sites within the heart.[0008]
• What are needed, therefore, are devices and methods to enable the repair of ASD, VSD, PDA, and other congenital defects, as well as cardiac arrhythmias and other diseases of the heart, which eliminate the need for gross thoracotomy and cardioplegic arrest, but which overcome the forementioned problems with intravascular techniques. The devices and methods should facilitate a high level of control for precise manipulation within the heart. The devices and methods should produce a septal defect or PDA repair which is reliable and long-lasting, and should not be susceptible to migration, embolization, or reopening of a defect. The devices and methods for septal defect and PDA repair should allow the position of a repair patch to be inspected after initial placement and to be repositioned if necessary. Finally, the devices and methods should not risk damaging the peripheral vessels of the patient, nor should the size and configuration of the devices be limited by the size of the patient's peripheral vessels.[0009]
SUMMARY OF THE INVENTION
• The invention provides devices and methods that facilitate thoracoscopic access into the interior of the heart whether or not the heart is beating. This intracardiac access can be used to perform a variety of diagnostic and treatment procedures within the heart without the need for a gross thoracotomy or cardioplegic arrest. The invention provides devices and methods for the performance of a number of different procedures including the repair of ASD, VSD, PDA, and other cardiac abnormalities, electrophysiologic mapping and ablation for the treatment of cardiac arrhythmias, as well as a variety of other intracardiac procedures that can be performed thoracoscopically on a beating heart.[0010]
• In a first aspect of the invention, a tubular access device is provided for accessing an interior chamber of a patient's heart. The access device includes an elongated tubular body configured to extend percutaneously through an intercostal space between the ribs of the chest and through a muscular wall of the heart, and an inner lumen extending through the tubular body which provides an access channel into the heart. In an exemplary embodiment, the tubular access device has a length of at least 10 cm, and the inner lumen has a diameter of at least 5 mm. Preferably, the tubular access device is rigid to facilitate responsive and precise positionability from its proximal end.[0011]
• In one embodiment, the access device includes means near a distal end thereof for sealing peripherally around a surrounding penetration in the muscular heart wall through which the access device is positioned. The sealing means may comprise one or a pair of inflatable balloons, a radially-expandable portion of the tubular body, or a flange at the distal end of the body. A purse string suture or other tissue-gathering means may be applied to the muscular heart wall surrounding the tubular body and tightened to prevent blood from flowing through the penetration around the access device.[0012]
• The invention may further include an obturator positionable within an inner lumen of the tubular access device. The obturator may have means at its distal end for penetrating the muscular wall of the heart. The penetrating means may comprise a blade, radiofrequency electrode, or other type of cutting element. In a preferred embodiment, the obturator further includes means for selectively exposing the penetrating means, which may include a movable actuator for extending and retracting the cutting means from the distal end of the obturator.[0013]
• The access device may include a hemostasis valve in the inner lumen to prevent blood flow out of the heart through the inner lumen, and to allow instruments to be introduced through the inner lumen while maintaining hemostasis in the inner lumen. The hemostasis valve may be disposed at either the proximal end or the distal end of the access device. Alternatively, when the access device is utilized in the lower-pressure right atrium, right ventricle, or left atrium, the access device may be positioned in a generally vertical orientation so that blood flow through the inner lumen is prevented by the pressure head of blood within the inner lumen being greater than the pressure in the cardiac chamber, eliminating the need for a hemostasis valve. With the access device positioned through an intercostal space and through a wall of the heart, a straight and relatively large channel directly into the interior of the heart is available for the introduction of devices for diagnostic and treatment procedures.[0014]
• The invention further provides an assembly for visualization and access within a body cavity, and particularly, for visualization and access into a patient's heart. The assembly includes a guide sleeve having a distal end, a proximal end, and a lumen therebetween. An endoscope is slidably positionable in the lumen, the endoscope having a shaft, a channel extending longitudinally through the shaft, at least one lens in the channel, and, usually, an eyepiece at the proximal end of the shaft. Alternatively, the endoscope may be of the type in which a video-imaging charge-coupled device (CCD) chip is mounted at the distal end of an elongated shaft and electronically coupled to a video processor which sends a video signal to a monitor. A transparent bulb is disposed at the distal end of the shaft outside of the channel and optically aligned with the lens. In this way, the transparent bulb serves to displace blood away from the distal end of the endoscope to allow the user to view the interior of the heart. Usually, the transparent bulb will be placed in contact with the intracardiac surface to be viewed, and the assembly then manipulated to inspect the surface or to identify a particular feature on the surface such as a septal defect.[0015]
• The transparent bulb may be mounted to the distal end of the endoscope itself, or mounted to the end of a separate elongate sheath having a lumen in which the endoscope may be positioned with the distal end of the endoscope adjacent to the bulb. The use of a separate elongate sheath allows any of various commercially-available endoscopes to be utilized for intracardiac viewing without modification. The transparent bulb may also be mounted to a steerable endoscope having a deflectable end, or to a flexible sleeve in which a steerable endoscope may be positioned such that the sleeve may conform to the configuration of the endoscope.[0016]
• In some embodiments, the transparent bulb is substantially rigid, being made of a clear, rigid polymer or glass. In other embodiments, the transparent bulb may be an expandable member such as an inflatable balloon, allowing the bulb to be collapsed into a small configuration for introduction into the heart, then expanded within the heart. The transparent bulb preferably has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft, and may further have a convex distal surface, facilitating the viewing of an area within the heart that is wider than that seen through the endoscope alone.[0017]
• The guide sleeve has a length sufficient to reach an interior of a patient's heart from outside the patient's chest, usually being at least about 15 cm for pediatric use, or at least about 20 cm for adult use. The entire assembly is positionable in the heart through the inner lumen of the access device described above, or may be directly positioned in the heart through a penetration in a wall of the heart and sealed by means of a purse-string suture. The guide sleeve usually has an outer diameter of less than about 12 mm, and is preferably rigid to facilitate positioning the guide sleeve by manipulation of its proximal end. The guide sleeve may alternatively be flexible, with rigidity being provided by the placement of a rigid obturator or the endoscope itself through the guide sleeve.[0018]
• The access and visualization assembly is useful in various medical procedures, but will find particular utility in intracardiac procedures in which the heart is to remain beating, such as septal defect repair. In use, the guide sleeve and endoscope are positioned in the heart through the inner lumen of the access device of the invention or directly through a penetration in the heart wall. The transparent bulb is positioned in contact with the intracardiac surface to be viewed, such as the interatrial septum. The proximal end of the assembly is then manipulated from outside the chest to inspect the surface and identify the location of treatment, such as a septal defect. Once located, the distal end of the guide sleeve is positioned through the defect, and the endoscope and transparent bulb are then withdrawn from the guide sleeve. The guide sleeve thereafter provides a conduit directly to the septal defect from outside the heart without requiring further use of the endoscope or other visualization devices to locate the defect. Defect repair devices may then be positioned through the guide sleeve directly to the septal defect to achieve the repair.[0019]
• The invention also provides systems and methods for repairing atrial and ventricular septal defects through the guide sleeve of the above-described access and visualization assembly. The septal defect repair system includes a closure device for closing or occluding the septal defect, and a delivery device for introducing the closure device through the guide sleeve and into the interior of the heart.[0020]
• In a first embodiment, the closure device comprises a patch that may be attached to the cardiac septum to cover and occlude the septal defect. The patch includes a collapsible frame, and a flexible patch material attached to the frame. The flexible patch material may be an artificial biocompatible material such as polyester or expanded polytetrafluorethylene, or a portion of the patient's pericardium or other natural body membrane. The frame is configured to support the patch material at its outer edges in a generally flat configuration, and is sufficiently rigid to retain its shape against the pressure of blood within the heart, while having sufficient flexibility and resiliency to be collapsible for introduction through the inner lumen of the access device. In an exemplary embodiment the frame comprises a hub and a plurality of spokes extending radially outward from the hub. A circumferential wire or suture thread extending between the outer tips of the spokes may be provided to continuously support the outer edges of the patch. The hub is a rigid material such as stainless steel, is small enough to fit within the inner lumen of the access device, and is configured to be detachably coupled to the distal end of an delivery shaft (described below). The spokes are flexible, resilient wires of Nitinol™ or other material exhibiting similar super-elastic characteristics. The patch may be mounted to the frame by sutures, heat welding, adhesive, or other means.[0021]
• The patch includes a means for securing the patch to the cardiac septum. The securing means may comprise a second patch coupled to a central portion of the first patch and parallel thereto such that one patch may be positioned through the septal defect on the left side of the cardiac septum and the second patch positioned on the right side of the cardiac septum, with the outer edges of the two patches compressively engaging the cardiac septum between them. For example, in the hub and spoke embodiment describe above, two sets of spokes nay be mounted to the hub and a patch mounted to each set of spokes so that the two patches are generally parallel to each other and spaced slightly apart. Alternatively, the securing means may comprise a plurality of flexible wire struts coupled to a central part of the frame such that the outer ends of the struts will compressively engage the cardiac septum on the side opposite that on which the patch is positioned. Like the patch, the securing means is collapsible to allow introduction through the inner lumen of the access device. To facilitate secure fixation to the septum, the frame or the securing means may include pins or spikes pointing generally perpendicular to the patch to partially penetrate the cardiac septum when the patch has been positioned across the defect, preventing migration of the patch.[0022]
• The patch is introduced into the heart and positioned across the septal defect by means of a rigid delivery shaft which may be positioned through the guide sleeve. The delivery shaft includes an interior lumen or aperture at its distal end for receiving the patch and securing means in a collapsed configuration. The delivery shaft further includes a means for deploying the patch and the securing means, which may comprise a rod slidably disposed in a lumen through the delivery shaft. The rod includes means at its distal end for releasably coupling to the patch, such as a threaded extension which couples to a threaded hub in the patch frame. The rod may be advanced distally relative to the delivery shaft to deploy the patch from the aperture into the heart chamber on the side of the cardiac septum further away from the point of introduction, e.g., the left atrium if the device has been introduced into the heart through the right atrium. The patch is positioned against the septum, and the securing means is deployed on the side of the cardiac septum opposite the patch, e.g., the right atrium in the aforementioned case. The rod may then be decoupled from the patch and the delivery shaft is removed from the patient through the access device.[0023]
• Advantageously, the delivery shaft and deployment means are configured to allow the patch to be re-collapsed and repositioned if the position of the patch is not satisfactory after initial deployment. In one embodiment, the rod is drawn proximally relative to the delivery shaft, whereby the patch is collapsed by engagement with the distal end of the delivery shaft. The patch securing means may be collapsed in a similar manner, or by a separate mechanism. In an exemplary embodiment, one or more wires or sutures extend through a lumen in the delivery shaft and are coupled to the securing means, e.g. to the outer ends of the spokes or struts of the securing means. By exerting tension on the wires, the securing means is drawn proximally into a collapsed configuration to allow it to be received in the aperture in the delivery shaft. This allows the patch and securing means to be drawn back into the aperture in the delivery shaft and redeployed at the desired position.[0024]
• In an alternative embodiment, the septal defect closure device comprises a suturing device for applying at least one suture across the septal defect. The suturing device includes a rigid delivery shaft suitable for introduction through the guide sleeve, and a plurality of needle holders mounted to the delivery shaft for releasably holding at least two needles connected by a suture thread. The needle holders are movable between a contracted position suitable for introducing the needles through the septal defect into the cardiac chamber on the opposite side of the septum, and an expanded position in which the tips of the needles are aimed proximally toward the cardiac septum on opposing sides of the septal defect. In one embodiment, the needle holders are mounted on opposing sides of a balloon which may be deflated during introduction through a septal defect and then inflated to move the needles into the expanded position. The needle holders are then pulled proximally so that the needles penetrate the cardiac septum. A means is mounted to the delivery shaft for capturing the distal tips of the needles after penetrating the septum. For example, the needles may have barbed tips which engage a porous fabric disk slidably mounted to the delivery shaft. The needle capture means is retracted to draw the needles through the septum and out of the heart through the inner lumen of the access device. In this way, a plurality of sutures may be applied to the cardiac septum simultaneously. Knots may then be tied in the sutures extracorporeally, and, using a long-handled endoscopic knot-pusher, pushed through the access device into the heart so as to tighten the sutures and draw the opposing sides of the septal defect together.[0025]
• In a further aspect of the invention, a method of locating an opening in a patient's heart comprises the steps of positioning a visualization scope through a sleeve; positioning a distal end of the visualization scope into the heart through a penetration in a wall thereof; viewing the opening through the visualization scope; sliding the sleeve into the opening; and removing the visualization scope from the sleeve. The opening may comprise a septal defect, patent ductus arteriosus, or any of a variety of other intracardiac formations. The method may further include positioning the visualization scope in a sheath outside the heart such that a distal end of the visualization scope is adjacent to a transparent bulb on a distal end of the sheath; positioning the sheath in the heart through the sleeve; and viewing the opening through the transparent bulb.[0026]
• If the opening is a septal defect or patent ductus arteriosus, the method may further include the steps of positioning a repair device through the sleeve while the sleeve is positioned through the opening; and closing the opening with the repair device. The repair device may comprise a patch which is secured across the opening, or a device for suturing the opening closed. In most embodiments, the visualization scope and the sleeve are positioned through an access device extending from outside the chest through the penetration in the wall of the heart.[0027]
• While the method of the invention may find use in open-chest surgical procedures, it is preferably performed using thoracoscopic techniques, wherein the ribs and sternum remain intact and are not significantly retracted during each step of the procedure. Using such techniques, a working space may be created in the patient's chest cavity by collapsing one of the patient's lungs or using jet ventilation techniques. A viewing scope such as an endoscope or endoscopic surgical microscope may then be introduced through an intercostal space into the working space to view the exterior of the heart while the penetration is formed and the access device is introduced. The viewing scope may include a video camera to provide a video image of the heart for display on a monitor which can be viewed during the procedure. Alternatively, the heart may be viewed directly through a lens on the viewing scope or through a trocar sleeve positioned in an intercostal space. While it may be desirable to place the patient on cardiopulmonary bypass and arrest the heart during certain procedures, the invention facilitates the performance of a number of cardiac procedures while the heart is beating, without the need for cardiopulmonary bypass or cardioplegic arrest, and with significantly reduced risk of injury resulting from embolism.[0028]
• Usually, the method will be performed in the right atrium, right ventricle, or left atrium, in which blood pressure is lower than in the left ventricle. Preferably, the access device is positioned in a vertical orientation, usually from a lateral side of the chest, with the distal end of the access device disposed in the interior chamber. In this way, the static pressure head of blood within the inner lumen is equal to the pressure within the interior chamber, preventing the flow of blood out of the interior chamber through the inner lumen. In an exemplary embodiment, small incisions and/or access ports are placed in the third, fourth, fifth, or sixth intercostal spaces on a lateral side of the chest. At least three such ports are usually required, one for introduction of the access device, one for introduction of a visualization device such as an endoscope, and one for introduction of other instruments for suturing, retraction, and other purposes.[0029]
• In addition to the use of the assembly described above, visualization within the interior of the heart may be provided by various means. An ultrasonic probe may be positioned in the patient's esophagus, on the surface of the patient's chest, or in the chest cavity adjacent or in contact with the exterior of the heart to ultrasonically image the interior of the heart. An angioscope introduced into the heart endovascularly through a peripheral vessel may also be used for intracardiac visualization. Fluoroscopy is an additional technique for visualization.[0030]
• The devices and methods of the invention may also be useful in other types of cardiac treatment procedures, including repair and replacement of cardiac valves, electrophysiological mapping and ablation, Cox “maze” surgical transection of the atrium, transmyocardial laser revascularization, pulmonary thrombectomy, intracardiac inspection, removal of growths, myxomas, neoplasms, hypertrophic obstructive cardiopmyopathy and vegetations, and other diagnostic and treatment procedures.[0031]
• The nature and advantages of the invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying exemplary drawings.[0032]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of an intracardiac access device according to the invention.[0033]
• FIG. 2 is a front partial cut-away view of a patient's heart showing the intracardiac access device positioned through a wall thereof.[0034]
• FIGS.[0035]2A-2E are side views of a distal portion of the intracardiac access device of FIG. 1 showing various alternative types of sealing means.
• FIGS.[0036]3A-3C are side, top, and end views, respectively, of the obturator of an intracardiac access device according to the invention with the cutting means retracted.
• FIGS.[0037]3D-3F are side, top, and end views, respectively, of the obturator of an intracardiac access device according to the invention with the cutting means extended.
• FIG. 4 is a front cut-away view of a patient's chest showing cutting the pericardium to expose the heart according the method of the invention.[0038]
• FIG. 5 is a front cut-away view of a patient's chest showing the placement of a purse-string suture in a muscular wall of the heart according to the method of the invention.[0039]
• FIG. 6 is a front cut-away view of a patient's chest showing the penetration of the muscular wall of the heart according the method of the invention.[0040]
• FIG. 7 is a front cut-away view of a patient's chest showing the position of the access device of FIG. 1 through the penetration in the muscular wall of the heart according to the method of the invention.[0041]
• FIG. 8A is a front cut-away view of a patient's chest showing the position of the access device of FIG. 1 through the penetration in the muscular wall of the heart with a balloon-type sealing means expanded according to the method of the invention.[0042]
• FIG. 8B is a front cut-away view of a patient's chest showing the use of an endoscope having a balloon over its distal end in a method of visualizing the interior of the heart according to the invention.[0043]
• FIG. 9 is a front cut-away view of a patient's chest showing the deployment of a distal patch of a septal defect repair device in a chamber of the heart according to the method of the invention.[0044]
• FIG. 10 is a side elevational view of a partially-deployed distal patch of a septal defect repair device useful in the method of the invention.[0045]
• FIGS.[0046]11A-11B are side cross-sectional and end views, respectively, of a hub of the distal patch of FIG. 10.
• FIG. 12 is a side elevational view of a proximal patch of a septal defect repair device useful in the method of the invention.[0047]
• FIGS.[0048]13A-13B are side cross-sectional and end views, respectively, of a hub of the proximal patch of FIG. 12.
• FIG. 14 is a side cross-sectional view of the septal defect repair device of FIGS.[0049]10-13 positioned in a lumen of a delivery shaft according to the method of the invention.
• FIG. 15 is a front cut-away view of a patient's chest showing the expansion of the distal patch of FIG. 10 in the left side of the heart according to the method of the invention.[0050]
• FIG. 16 is a front cut-away view of a patient's chest showing the deployment of the proximal patch of FIG. 12 in the right side of the heart according to the method of the invention.[0051]
• FIG. 17 is a front cut-away view of a patient's chest showing the expansion of the proximal patch of FIG. 12 in the right side of the heart according to the method of the invention.[0052]
• FIG. 18 is a front cut-away view of a patient's chest showing the attachment of the proximal patch to the distal patch to repair the septal defect according to the method of the invention.[0053]
• FIG. 19 is a front cut-away view of a patient's chest showing the closure of the penetration in the muscular wall of the heart according to the method of the invention.[0054]
• FIG. 20 is a transverse cross-sectional view of the patient's chest showing an alternative technique for closing the penetration in the muscular wall of the heart according to the method of the invention.[0055]
• FIGS. 21A, 22A, and[0056]23 are top partial cut-away views of alternative embodiments of a septal defect repair device according to the principles of the invention.
• FIGS. 21B and 22B are side cross-sectional views of the septal defect repair devices of FIGS. 21A and 22A, respectively.[0057]
• FIG. 24A is a top partial cut-away view of a further embodiment of a septal defect repair device according to the principles of the invention.[0058]
• FIG. 24B is a side partial cut-away view of the septal defect repair device of FIG. 24A.[0059]
• FIG. 24C is a front view of a further embodiment of a septal defect repair device according to the invention.[0060]
• FIG. 24D is a side cross-section of the septal defect repair device of FIG. 24C.[0061]
• FIG. 24E is a side view of the septal defect repair device of FIG. 24C with the patch material removed.[0062]
• FIGS.[0063]24F-G are front and side views, respectively of a hub in the septal defect repair device of FIG. 24C.
• FIG. 24H is a side partial cross-section of the septal defect repair device of FIG. 24C in a collapsed configuration within a delivery shaft.[0064]
• FIG. 25A is a side cut-away view of the septal defect repair device of FIGS.[0065]24A-24B positioned in a collapsed configuration within a delivery shaft.
• FIG. 25B is a side cut-away view of an actuator handle for deployment of the septal defect repair device of FIGS.[0066]24-24B.
• FIGS.[0067]26A-26B is a side cross-sectional view showing the attachment of the septal defect repair device of FIGS.24A-24B to a cardiac septum according to the method of the invention.
• FIG. 27 is a front cut-away view of a patient's chest showing the introduction of a suturing device into the heart for repairing a septal defect in an alternative embodiment of the method of the invention.[0068]
• FIG. 28 is a front cut-away view of a patient's chest showing the expansion of a plurality of needles at the distal end of the suturing device according to the method of the invention.[0069]
• FIG. 29A is a front cut-away view of a patient's chest showing drawing the plurality of needles through the cardiac septum according to the method of the invention.[0070]
• FIG. 29B is a side view of the cardiac septum in the patient's chest of FIG. 29A showing the position of the needles through the cardiac septum according to the method of the invention.[0071]
• FIG. 30A is a side view of the cardiac septum of FIG. 29B showing capturing the needles in a capture disk according to the method of the invention.[0072]
• FIG. 30B is a side view of the cardiac septum of FIG. 30A showing withdrawing the needles from the cardiac septum according to the method of the invention.[0073]
• FIG. 31A is a top view of the cardiac septum of FIG. 30A showing the position of the sutures across the septal defect according to the method of the invention.[0074]
• FIGS.[0075]31B-31C are perspective views of the cardiac septum of FIG. 31 A showing tensioning and tying the sutures to close the septal defect according to the method of the invention.
• FIGS.[0076]32A-32D are side views of an alternative embodiment of a suture-type septal defect repair device according to the invention, showing the deployment of the needles in the cardiac septum and the capture of the needles according to the method of the invention.
• FIG. 33 is a front cut-away view of a patient's chest showing an electrophysiology device according to the invention positioned through the access device of FIG. 1 in a method of electrophysiological treatment according to the invention.[0077]
• FIG. 34 is a front cut-away view of a patient's chest showing an alternative embodiment of an electrophysiology device according to the invention positioned through the access device of FIG. 1 in a method of electrophysiological treatment according to the invention.[0078]
• FIGS.[0079]35A-35C are side partial cut-away views of an intracardiac visualization and access device according to the invention.
• FIGS.[0080]36A-E are anterior views of a heart in a patient's chest schematically illustrating the use of the intracardiac visualization and access device of FIGS.35A-C.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
• A first representative embodiment of an intracardiac access system according to the invention is illustrated in FIG. 1. The[0081]intracardiac access system20 includes atubular access device22 comprising arigid shaft24 having adistal end26, aproximal end28, and aninner lumen30 extending therebetween.Access device22 includes a means neardistal end26 for hemostatically sealing a cardiac penetration through whichshaft24 is introduced, which may comprise atoroidal balloon32. Aninflation lumen34 extends throughshaft24 and has anopening36 in communication with the interior ofballoon32. Aninflation fluid port38 is mounted toshaft24 atproximal end28 in communication withinflation lumen34 and is configured for connection to an inflation fluid delivery source such as a syringe or other balloon inflation device.
• [0082]Access device22 is configured to extend percutaneously through an intercostal space and through a muscular wall of the heart withdistal end26 positioned in an interior chamber of the heart andproximal end28 positioned outside of the patient's chest cavity. In an exemplary embodiment, the tubular access device has a length of about 10 to 30 cm, preferably about 25 cm, and an outer diameter of less than about 15 mm, and preferably about 5-10 mm. To allow introduction of instruments for visualization and surgical intervention within the heart,inner lumen30 has a diameter of at least about 5 mm. Preferably,access device22 is a rigid material such as stainless steel, titanium, or a rigid polymer, with a minimum durometer of about 75 Shore A. Alternatively,shaft24 ofaccess device22 may be all or partially flexible with a minimum durometer of about 35 Shore A, and may also include pull wires or other means for steering or deflectingdistal end26.
• As illustrated in FIG. 2,[0083]distal end26 ofaccess device22 is configured to be introduced through a penetration incardiac wall40 of heart H. The hemostatic sealing means,e.g. balloon32, functions to seal the penetration around the exterior ofshaft24 to prevent leakage of blood through the penetration from the interior of heart H. As illustrated in FIGS.2A-2E, a variety of hemostatic sealing means may be utilized.Balloon32 may be mounted toshaft24 spaced a short distance fromdistal end26 so as to be positionable against the exterior surface ofcardiac wall40, as shown in FIG. 2A.Balloon32 may alternatively be mounted close todistal end26 so as to be positionable against the interior surface ofcardiac wall40 as shown in FIG. 2B. In addition, a pair ofballoons32,42 may be mounted toshaft24 spaced slightly apart to provide a seal on both sides ofcardiac wall40, as shown in FIG. 2C.
• In a further alternative embodiment, not pictured, either or both of[0084]balloons32,42 of FIG. 2C may be replaced by expanding mechanical elements, such as moly-type fittings which are expanded under compression exerted by, for example, sliding a slidable sleeve axially overshaft24 which engages the proximal ends of the fittings.
• In a further embodiment, shown in FIG. 2D,[0085]shaft24 may have aflange44 disposed atdistal end26,flange44 having aproximal end46 with an outer diameter larger than that ofshaft24. When flange44 is introduced through a cardiac penetration,proximal end46 offlange44 may be positioned so as to abut and seal against the interior surface ofcardiac wall40.Flange44 preferably has taperedside walls48 to facilitate introduction through the cardiac penetration. As shown in FIG. 2,balloon32 may be mounted toshaft24 spaced proximal toflange44 to compresscardiac wall40 between the balloon and the flange and seal the cardiac penetration both interiorly and exteriorly.
• In another embodiment, illustrated in FIG. 2E,[0086]shaft24 has a radially-expandingportion50 neardistal end26 which may be selectively expanded whendistal end26 has been positioned through the cardiac penetration. Exemplary radially-expanding dilators and cannulae having a construction suitable for application to the present invention are disclosed in U.S. Pat. Nos. 5,183,464 and 4,921,479, which are incorporated herein by reference. Aballoon32 may also be mounted toshaft24 distally of radially-expandingportion50 to seal against the interior surface ofcardiac wall40.
• In each of the forementioned embodiments, it will frequently be advantageous to place a purse string suture in[0087]cardiac wall40 or apply another means of gathering tissue around the cardiac penetration through whichshaft24 is introduced to enhance hemostasis. The placement of such a purse-string suture is described in detail below.
• Referring now to FIGS.[0088]3A-3C and3D-3F,cardiac access system20 further includes anobturator52 removably positionable ininner lumen30.Obturator52 comprises atubular shaft54 having adistal end56, aproximal end58, and anaxial lumen59.Distal end56 is conical in shape and has atransverse slot57 in communication withaxial lumen59. A cutting means60 for forming a penetration in a heart wall is slidably received withinslot57, and, in an exemplary embodiment, comprises astainless steel blade62 having a sharpeneddistal edge64 tapering to apoint66.Blade62 is coupled to alinkage72 slidably disposed inaxial lumen59. Ahandle74 is mounted toproximal end58 ofshaft54, and a slidingactuator76 is mounted to handle74.Linkage72 is coupled toactuator76, so thatactuator76 may be used to slideblade62 distally to exposeedge64 andpoint66. Acompression spring78 is disposed within an aperture inhandle74 and engages acollar79 onlinkage72 tobias blade62 proximally so that it is protected withinslot57.
• [0089]Actuator76 may be configured to lock in a distal position in whichblade62 is fully exposed, in a proximal position in whichblade62 is fully exposed, or in any other position between the two. In an exemplary configuration,actuator76 comprises abutton77 having anupper portion81 of smaller diameter which is slidable within achannel80 inhandle74, and having alower portion82 of larger diameter designed to seat within adetent84 at the proximal end ofchannel80.Button77 is biased upward by aspring85 to automatically lock intodetent84 when aligned therewith. In this way,blade62 is locked in the proximal position and is unlikely to be inadvertently exposed by the user. When exposure ofblade62 is desired,button77 is pushed downward and distally. Release of pressure onbutton77causes blade62 to retract automatically.
• The length of[0090]shaft54 is selected so that whenobturator52 is disposed withininner lumen30, cutting means60 extends distally ofdistal end26 ofaccess device22 and handle74 is near or againstproximal end28 ofaccess device22. In this way,blade62 may be used to create a penetration in the heart wall whileobturator52 is positioned withinaccess device22, allowingaccess device22 to be introduced through the heart wall as or immediately after the penetration is formed, thereby minimizing blood loss through the penetration. Onceaccess device22 is introduced through the cardiac penetration,obturator52 is withdrawn frominner lumen30.
• As will be described more fully below,[0091]access device22 is usually introduced into the right atrium, right ventricle, or left atrium in a vertical or near-vertical orientation so that blood flow out of the heart throughinner lumen30 is prevented by gravity—i.e., the pressure head of blood ininner lumen30 is equal to that in the cardiac chamber. In such cases, there is no need for a hemostasis valve withininner lumen30. However, in cases in whichaccess device22 is to be introduced into the higher pressure chamber such as the left ventricle, or in whichaccess device22 is to be positioned in an orientation in which blood might flow throughinner lumen30, a hemostasis valve (not shown) may be provided withininner lumen30. The hemostasis valve may be positioned at the proximal end, the distal end, or a mid-position withininner lumen30, and will be configured to allow instruments to be introduced throughinner lumen30 with minimal blood loss. Suitable hemostasis valves are described, for example, in U.S. Pat. Nos. 4,000,739, 4,436,519, 5,154,701, 4,946,133, 5,000,745, 4,177,814, and 5,300,033, which are incorporated herein by reference.
• A method of accessing the interior of the heart according to the invention will now be described with reference to FIGS.[0092]4-8. The method will be described in relation to accessing a left or right atrium of the heart from the right side of the chest, but it should be understood that the principles described will be equally applicable to accessing the left or right ventricle and using any of a variety of approaches.
• The patient is prepared for cardiac surgery in the conventional manner, and general anesthesia is induced. The patient is positioned on the patient's left side so that the right lateral side of the chest is disposed upward. Two to three small incisions 2-3 cm in length are made between the ribs, usually in the third, fourth, or fifth intercostal spaces. Thoracoscopic access ports[0093]90 (e.g. trocar sleeves or other tubular cannulae), are positioned in each incision to retract away adjacent tissue and protect it from trauma as instruments are introduced into the chest cavity.Access ports90 have an outer diameter which does not require retraction, cutting or removal of ribs, preferably less than 14 mm, and an axial passage with a diameter less than about 12 mm.Access ports90 may also be non-circular in cross-section, or may be made of a flexible material to deform into a non-circular shape when introduced between two ribs. The right lung is deflated using conventional techniques, usually by introducing a tube through the patient's trachea into the right lung and applying a vacuum through the tube to deflate the lung. An endoscopic visualization device such as athoracoscope92 connected to a video monitor (not shown) by acable93 is introduced through one ofaccess ports90 to visualize the interior of the chest cavity. Atraumatic retraction instruments may be introduced throughaccess ports90 to assist in deflating and retracting the lung, thereby providing a working space within the chest cavity.
• Referring to FIG. 4, in order to gain access to the heart, an opening is made in the[0094]pericardium94 using thoracoscopic instruments introduced throughaccess ports90, includingthoracoscopic scissors96 andthoracoscopic forceps98. Instruments suitable for use in this procedure are described in U.S. Pat. No. 5,501,698, which is incorporated herein by reference. An opening approximately 2 cm-8 cm square is formed in the pericardium, exposing the exterior of theheart100.
• As shown in FIG. 5, a[0095]purse string suture102 is then placed in thewall104 ofheart100 around the site at which it is desired to introduceaccess device22. This is accomplished by usingthoracoscopic needle drivers106 to introduce into the chest cavity acurved suture needle108 attached to one end of asuture thread110, and to drive the needle through the heart wall to form a running stitch in a circular pattern approximately 12-14 mm in diameter. A double-armed suture may also be used, wherein thesuture thread110 has needles at both ends, allowing each needle to be used to form one semi-circular portion of the purse-string.Suture thread110 may be long enough to allow both ends of the suture to be drawn outside of the chest cavity once purse-string suture102 has been placed, or it may be shorter and manipulated within the chest cavity using thoracoscopic instruments.Suture needle108 is then cut fromthread110 using thoracoscopic scissors.
• [0096]Access device22 may now be introduced intoheart100. In some cases, it may be advantageous to first place the patient on cardiopulmonary bypass and to place the heart under cardioplegic arrest before introducingaccess device22. Preferably, however,heart100 remains beating during the procedure to avoid the trauma and risks associated with cardioplegic arrest.Obturator52 is positioned withininner lumen30 ofaccess device22 so thatdistal end56 of the obturator is exposed distally ofdistal end26 of the access device.Access device22 withobturator52 positioned therein is introduced through anaccess port90 into the chest cavity, anddistal end56 of the obturator is positioned againstheart wall104 centrally within the bounds of purse-string suture102.Button77 onhandle94 of the obturator is then pressed downward and distally so as to extendblade62 fromdistal end56, causingblade62 to penetrate throughheart wall104. A thoracoscopic grasping instrument (not shown) may be used to grasp the heart wall near purse string suture102 to counter the insertion force ofblade62 andaccess device22. Asblade62 penetrates the heart wall,access device22 is advanced distally in conjunction withobturator52 so that both devices extend into the heart through thepenetration114 formed inheart wall104.
• Once[0097]distal end26 ofaccess device22, includingballoon32 orflange44 if used, is within the interior ofheart100, purse-string suture102 is cinched tightly to form a hemostatic seal aroundaccess device22, as shown in FIG. 7. One or a pair ofthoracoscopic cinching devices116 may be used for this purpose. Each cinchingdevice116 comprises ashaft118 with aslidable hook120 at its distal end which can be used to grasp a loop of purse-string suture102.Hook120 may retracted proximally to frictionally retainsuture thread110 against the distal end ofshaft118. Loops on opposing sides of purse-string suture102 may be grasped in this manner, and cinchingdevices116 then withdrawn proximally to cinch purse-string suture102 tightly, thereby gathering heart wall tissue against the exterior ofaccess cannula22 to form a hemostatic seal. Cinchingdevices116 may be clamped in position to maintain tension onsuture thread110. Alternatively, aslidable sleeve122 may be provided aroundshaft118. Once a suture loop has been secured inhook120,slidable sleeve122 may be slid distally relative toshaft118 until it abuts against the surface ofheart wall104.Shaft118 is then pulled proximally relative tosleeve122 to obtain the desired degree of tension onsuture thread110.Sleeve122 is configured to frictionally retainshaft118 in position to maintain tension on the suture.
• If a balloon or radially-expanding portion of[0098]access device22 is used to enhance hemostasis, it is now activated. The use of aballoon32, described above in reference to FIG. 2B, is illustrated in FIG. 8A. Oncedistal end26 ofaccess device22 is introduced into the interior ofheart100,balloon32 is inflated by introducing an inflation fluid such as saline through inflation lumen34 (FIG. 1). A syringe or other commercially-available inflation device connected toinflation port38 may be used for this purpose.
• [0099]Obturator52 is then withdrawn frominner lumen30 ofaccess device22. As described above,access device22 is preferably positioned in a vertical orientation so that outflow of blood from the heart throughinner lumen30 is prevented by gravity—that is, the pressure head of blood withininner lumen30 is equal to that in the cardiac chamber. In other cases, a hemostasis valve (not shown) is provided withininner lumen30 to prevent blood flow from the heart, while allowing instruments to be introduced through the access device.
• The patient has now been prepared for a diagnostic or treatment procedure to be carried out within[0100]heart100 throughaccess device22. Advantageously, the need for gross thoracotomy, cardiopulmonary bypass and cardioplegic arrest have been avoided, while providing a relatively large, straight, and hemostatically-sealed access passage directly into the interior of the heart.
• Visualization within the heart may be accomplished in any of several ways. Trans-esophageal echocardiography may be used, wherein an ultrasonic probe is placed in the patient's esophagus or stomach to ultrasonically image the interior of the heart. An ultrasonic probe may also be placed through one of[0101]access ports90 into the chest cavity and adjacent the exterior of the heart for ultrasonically imaging the interior of the heart.
• Alternatively, as illustrated in FIG. 8B, an[0102]endoscope121 having an optically transparent bulb such as aninflatable balloon123 over itsdistal end125 may be introduced throughaccess device22 into the interior of the heart.Balloon123 may be inflated with a transparent inflation fluid such as saline to displace blood away fromdistal end125 and may be positioned against a site such as septal defect D in septum S, allowing the location, shape, and size of defect D to be visualized. In one embodiment,endoscope121 is a conventional, commercially-available endoscope such as a V. Mueller Model No. LA 7005 (V. Mueller, Inc, Deerfield, Ill.), having atubular shaft127 in which one or more lenses (not shown) are mounted, aneyepiece129 at its proximal end for looking throughtubular shaft127, and aconnector131 for connection to a light source which transmits light through optical fibers (not shown) extending throughtubular shaft127 todistal end125.Endoscope121 is slidably positioned in anouter sleeve133 having adistal end135 to whichballoon123 is attached.Outer sleeve133 has aluer connection137 on its proximal end in communication with an inflation lumen (not shown) extending throughouter sleeve133 to anoutlet port139 atdistal end135 within the interior ofballoon123.Luer connection137 is adapted for connection to asyringe141 for injecting a transparent inflation fluid such as saline intoballoon123 for inflation thereof. A tubular,compliant seal143 is attached to a proximal end ofouter sleeve133 to provide a fluid-tight seal betweenendoscope121 andouter sleeve133. It will be understood to those of skill in the art that, instead of using separateouter sleeve133,balloon123 could be mounted directly todistal end125 ofendoscope121 and an inflation lumen provided inshaft127 for inflation of the balloon.
• In use,[0103]endoscope121 is positioned inouter sleeve133 outside of the patient, and the two are together introduced throughinner lumen30 ofaccess device22 withballoon123 evacuated of fluid in a collapsed configuration. Onceballoon123 is within the heart, saline is injected intoballoon123 to inflate the balloon to a diameter of approximately 2-6 cm.Balloon123 is then positioned against the site to be visualized, e.g., septum S around defect D. The size and location of the defect D may then be visualized by looking througheyepiece129. Additionally,endoscope121 may include a video camera mount to allow video imaging and remote viewing of the interior of the heart on a video monitor.
• Instead of a balloon or bulb over[0104]distal end125, saline may be injected under pressure through a lumen inendoscope121 or inouter sleeve131 and out of a port at or neardistal end125 to displace blood away from the distal end to provide a transparent field of view.
• As a further visualization alternative, an endoscope may be utilized which employs a specialized light filter, so that only those wavelengths of light not absorbed by blood are transmitted into the heart. The endoscope utilizes a CCD chip designed to receive and react to such light wavelengths and transmit the image received to a video monitor. In this way, the endoscope can be positioned in the heart through[0105]access device22 and used to see through blood to observe a region of the heart A visualization system based on such principles is described in U.S. Pat. No. 4,786,155, which is incorporated herein by reference.
• In still another alternative for visualization, particularly useful in imaging an atrial or ventricular septal defect, a very small-profile light source such as an optical fiber is positioned in the left atrium or left ventricle, opposite the right atrium or right ventricle in which[0106]access device22 is positioned. The light source may be introduced throughaccess device22 and through the septal defect into the left side of the heart, or it may be introduced through a minute puncture in the left side of the heart. The puncture may be closed by a purse-string suture if needed. An endoscope is then positioned throughaccess device22 into the right side of the heart opposite the light source. The endoscope utilizes a CCD chip designed to receive and react to those light wavelengths transmitted through blood, as well as any light wavelengths transmitted through the interatrial or interventricular septum. This produces a shadow-like image of the septal defect, which is received by the CCD and displayed on a video monitor, thereby imaging the size, shape and location of the septal defect.
• With[0107]access device22 in position in the heart and a means of visualization in place, a number of intracardiac procedures may be performed. One such procedure is the repair of atrial septal defects, which will now be described with reference to FIGS.9-32.
• FIGS.[0108]9-20 illustrate an exemplary embodiment of a system and method for repairing an atrial septal defect according to the invention. In these Figures, an umbrella-type septal defect repair patch is shown which is similar to that that described in U.S. Pat. No. 3,874,388 to King, which is incorporated herein by reference. It should be understood, however, that any of a number of different septal defect repair patches may be utilized in conjunction with the system and method of the invention without departing from the principles hereof. Some of the septal defect repair patches which could be utilized are described, for example, in U.S. Pat. Nos. 4,007,743, 5,334,217, 4,917,089, 5,284,488, and 5,108,420, which are incorporated herein by reference. Another septal defect repair patch which could be used with the present invention is disclosed in PCI application No. PCI/US92/10141 to Pavcnik, published Jun. 10, 1993.
• As shown in FIG. 9, the septal defect repair system of the invention includes, in addition to[0109]access device22 described above, adefect repair device130 and a delivery means132.Defect repair device130 comprises, in this embodiment, a double umbrella-type patch similar to that described in the '388 patent to King. Delivery means132 comprises atubular delivery shaft134 having adistal end136 positionable throughinner lumen30 ofaccess device22, and a proximal end (not illustrated in FIG. 9) which is used to manipulate delivery means132 from outside of the chest cavity. An outertubular control rod138 is slidably disposed withindelivery shaft134, and aninner control rod140 is slidably disposed withinouter control rod138.Inner control rod140 has adistal end142 detachably coupled to adistal patch144 ofdefect repair device130.
• Preferably,[0110]delivery shaft134 is generally straight and rigid to facilitate introduction throughaccess device22 and manipulation of delivery means132 from its proximal end.Delivery shaft134 is thus stainless steel, titanium, another biocompatible metal, or a biocompatible polymer with a minimum durometer of 75 Shore A.Outer control rod138 andinner control rod140 are preferably also a rigid material such as stainless steel or titanium, although some flexibility may be tolerated in these members since they are supported exteriorly bydelivery shaft134, so long as the inner and outer control rods have sufficient column strength to perform their respective functions, as described below.
• The details of an exemplary embodiment of[0111]defect repair device130 are illustrated in FIGS.11,12A-12B,13 and14A-14B, which show a double-umbrella device similar to that disclosed in the King patent. FIG. 11 illustratesdistal patch144, which includes acentral hub146 to which a plurality, e.g. six, radially-extendingstruts148 are coupled.Hub146 and struts148 are a rigid material such as stainless steel or a biocompatible polymer.Struts148 include sharpenedpoints149 pointing generally perpendicular to the struts at their outer ends for penetrating the cardiac septum. A biocompatibleflexible fabric150 of a polyester such as Dacron™, an expanded polytetrafluoroethylene such as Gore-Tex® (W. L. Gore and Assoc., Inc.), silk, nylon, silastic, a portion of the patient's pericardium, or other biocompatible flexible material impervious to blood is attached tohub146 by akeeper152 and to struts148 bysutures154.
• As shown in FIGS.[0112]11A-11B, struts148 may be hingedly coupled tohub146 by means of ahinge ring156 which extends through aneyelet158 at the end of each strut.Hinge ring156 and struts148 are retained onhub146 bykeeper152. Alternatively, struts148 may be a resilient, flexible material and rigidly coupled tohub146 so as to naturally assume a radially expanded configuration when unrestrained. A plurality ofaxial grooves159 are provided onhub146 to receivestruts148 when collapsed inward.Hub146 further includes a threadedhole160 on its proximal end into which the threaded distal end ofinner control rod140 may be threaded. Acircumferential flange162 is disposed about the proximal end ofhub146 for attachment to the proximal patch of the defect repair device, as described below.
• Referring to FIGS. 12 and 13A-[0113]13B,defect repair device130 further includes aproximal patch164 having a construction much likedistal patch144. A plurality ofstruts166 are hingedly coupled to acentral hub168 by means of ahinge ring170 extending througheyelets172 in the inner ends of the struts. Eachstrut166 has an inwardly extendingpoint174 at its outer end for engaging the cardiac septum. Aflexible fabric membrane176 is attached tohub168 by akeeper180 and to struts166 bysutures182.Additional suture loops184 are attached to struts166 to allow attachment of tie wires for deployment ofproximal patch164, as described below.
• As shown in FIGS.[0114]13A-13B,hub168 has a plurality ofaxial grooves186 for receivingstruts166 in a collapsed configuration.Hub168 also has anaxial passage188 of sufficient diameter to allowinner control rod140 to extend slidably through it with minimal friction. On its distal end,hub168 has acavity190 having anannular groove192 for receivingcircumferential flange162 ofhub146 in a snap-fit relationship.
• Referring to FIG. 14, during introduction through[0115]access device22,distal patch144 andproximal patch64 are preferably positioned in a collapsed configuration withindelivery shaft134 neardistal end136.Inner control rod140 is positioned slidably throughouter control rod138, throughaxial passage188 inhub168 ofproximal patch164, and threaded intohole160 indistal patch144.Tie wires194 are attached to sutureloops184 and extend proximally throughdelivery shaft134 out of the chest cavity. As shown in FIG. 9,delivery shaft134 is introduced through the right atrium RA and into the left atrium LA through septal defect D.Inner control rod140 is then advanced distally relative todelivery shaft134 to deploydistal patch144 out ofdelivery shaft134 into left atrium LA.
• As illustrated in FIG. 15, with[0116]distal patch144 deployed in the left atrium,inner control rod140 is pulled proximally relative todelivery shaft134 untildistal end136 of the delivery shaft engages struts148 (not shown in FIG. 15), urgingstruts148 outward to a radially expanded position in whichdistal patch144 is generally disk-shaped and parallel to cardiac septumS. Delivery shaft134 andcontrol rod140 are then pulled proximally in the direction of arrow A1 untildistal patch144 engages septum S and points149 ofstruts148 partially penetrate septum S. This is done under visualization by TEE or one of the other techniques described above in order to ensure proper positioning ofdistal patch144 so as to fully block blood flow across defect D. If, after initial placement, shunting of blood is detected across the defect,distal patch144 may be repositioned by advancingdelivery shaft134 distally to disengagepatch144 from septum S, then manipulatingdelivery shaft134 to positiondistal patch144 in the desired location. The straightness, rigidity, and relatively short length ofdelivery shaft134 provide the user a high degree of control and precision in placing the patch in the best possible position on septum S.
• In some cases it may desirable to have the capacity to re-collapse[0117]distal patch144 and replace it withindelivery shaft134 for repositioning or removal from the patient. In such cases, tie wires may be provided which are coupled to the inner sides ofstruts148 and extend throughdelivery shaft134 out of the chest cavity. By tensioning the tie wires, struts148 may be urged back into a collapsed position anddistal patch144 then pulled back intodelivery shaft134.
• With[0118]distal patch144 anchored in septum S,proximal patch164 is next deployed in the right atrium RA, as illustrated in FIG. 16. This is accomplished by pullingdelivery shaft134 proximally to provide some space between itsdistal end136 and septum S.Outer control rod138 is then advanced distally relative todelivery shaft134 to deployproximal patch164 out ofdelivery shaft134 in the direction of arrow A2.Proximal patch164 andouter control rod138 slide relative toinner control rod140, which is maintained in tension to keepdistal patch144 against septum S.
• As shown in FIG. 17,[0119]tie wires194 are then tensioned so as lo urge struts166 outward into a radially expanded position in whichproximal patch164 is generally disk-shaped and parallel to septum S. As illustrated in FIG. 18,outer control rod138 andproximal patch164 are then advanced distally overinner control rod140 untilhub168 of the proximal patch engages and snaps intohub146 ofdistal patch144.Points174 on the ends ofstruts166 partially penetrate septum S to anchor the patch in position.Tie lines194 are removed fromproximal patch164, by, for example, cutting the tie lines with a cutting instrument introduced throughaccess device22 after removal ofdelivery shaft134. Alternatively,tie lines194 may be looped throughsuture loops184 onproximal patch164 so that both ends extend out of the chest cavity, in which case one end of each tie line is simply pulled through the suture loop to remove the tie line.
• It will be understood to those of ordinary skill in the art that a variety of different types of actuators of well-known construction may be employed at the proximal end of delivery means[0120]132 to allow the user to selectively deploydefect repair device130 in the heart. In one embodiment, not pictured, a handle is fixed to the proximal end ofdelivery shaft134 which is suitable for being grasped in the user's hand. A pair of slidable buttons are mounted to the handle, one being coupled to the proximal end of theinner control rod140 and the second being coupled to the proximal end ofouter control rod138. In this way, the user can independently deploydistal patch144 andproximal patch164 by sliding the respective buttons on the handle. A passage is also provided in the handle in communication with the interior ofdelivery shaft134 to allowtie wires194 to extend out of the delivery shaft outside of the patient's body.
• [0121]Delivery shaft134, along withinner control rod140 andouter control rod138, are then removed from the chest cavity throughaccess device22. If desired, the defect repair may be inspected by placing an endoscope with a transparent bulb or balloon over its distal end throughaccess device22 into right atrium RA. The bulb or balloon is positioned against septum S and/orproximal patch164 to inspect the position of the patch and to determine whether the septal defect has been completely occluded. Shunting of blood may also be detected using TEE or other ultrasonic technique. If patch position is satisfactory,access device22 may be removed from the patient. Balloon32 (if used) is deflated, andaccess device22 is withdrawn from the penetration inheart wall104. As shown in FIG. 19,sutures110 are pulled tight asaccess device22 is withdrawn to close the penetration without significant loss of blood from the heart. Knots are tied insutures110, usually extracorporeally, and slid into the chest cavity and againstheart wall104 using anendoscopic knot pusher196 introduced throughaccess port90. This may be done under visualization with an endoscope introduced through a separate access port90 (not shown in FIG. 19).Sutures110 are then trimmed off with a pair of endoscopic scissors.
• An alternative method of closing the penetration in the heart wall is illustrated in FIG. 20. In this technique, an endoscopic staple applier is used to apply one or more staples to the heart wall across the penetration. A staple applier such as, for example, an AutoSuture™ Powered Multifire Endo TA60 device available from United States Surgical Corp. of Norwalk, Conn., may be utilized. Under visualization using an endoscope positioned in an[0122]access port90,stapler198 is introduced through anaccess port200 in the anterior wall of the patient's chest so that theanvils202 are generally parallel toheart wall104. The heart wall around the penetration is pursed up using endoscopic forceps so thatanvils202 can be positioned around a portion of the myocardium that includes the penetration. The stapler is then actuated, applying a row of staples through the heart wall across the penetration to seal it closed.
• With the penetration in[0123]heart wall104 closed, the procedure is completed by removing allaccess ports90 and closing all percutaneous incisions. The right lung is re-inflated, the endotracheal tube is removed, and the patient is recovered from anesthesia.
• Additional embodiments of[0124]defect repair device130 of the invention are illustrated in FIGS.21A-21B,22A-22B,23, and24A-24B.Defect repair devices130A,130B,130C of FIGS.21-23 each include adistal patch206,208,210, and aproximal patch212,214,216. The patches are a flexible, biocompatible, and blood impervious material, preferably conducive to endothelialization after implantation. Suitable materials include polyester mesh, knit fabrics of expanded polytetrafluoroethylene treated for low porosity, absorbable polyhydroxybutyrate, autologous pericardium, bovine or porcine pericardium, polyurethane and polypropylene mesh. The proximal and distal patches are attached together in a parallel relationship by an attachment means218,220,222 forming a ring at the center of the patches. Attachment means218 may comprise a single suture in a circular running stitch, a plurality of individual knotted suture loops, rivets, or other fasteners, or adhesive bonding, heat welding, or ultrasonic welding. Awire support frame224,226,228 is attached around the outer edges of the distal and proximal patches, preferably by folding the outer edges of the patch around the frame and suturing or bonding the patch to itself, thereby enclosing the support frame within the patch material. On each patch,support frame224,226,228 is preferably a single continuous wire of Nitinolr™, a superelastic nickel-titanium alloy available from Raychem Corporation, titanium, or stainless steel.Support frame224,226,228 includes a plurality ofloops230,232,234 formed in the plane of each patch to allow for longitudinal flexing and bending of the frame to facilitate collapsing the patches during introduction. The loops may be formed outwardly to lie outside of the periphery of each side of the frame as illustrated in FIG. 21A, or inwardly to lie within the periphery of the frame as illustrated in FIGS. 22 and 23.
• In the embodiment of FIGS.[0125]22A-22B,defect repair device130B includes acentral hub236 attached to distal andproximal patches208,214.Hub236 has apost238 extending throughpatches208,214, and aretainer240 threaded or press-fit onto the distal end ofpost238, thereby fixinghub236 to the patches.Hub236 also has a threadedhole242 in its proximal end to which an introducer shaft may be threadably coupled. By allowingdefect repair device130 to be coupled to an introducer shaft viahub236, the user is given a higher degree of control in positioning and repositioning the patch, as described more fully below. It should be understood that any of the embodiments in FIGS.21A-21B and23 may be provided with a hub likehub236 of FIG. 22.
• [0126]Patches212,214,216 may have any of a variety of shapes including square or rectangular (FIGS. 21 and 22), hexagonal (FIG. 23), triangular, octagonal, pentagonal, circular, oval, or other shape. A defect repair device like those disclosed in U.S. Pat. No. 5,334,217 to Das, which is incorporated herein by reference, may also be utilized in conjunction with the present invention.
• FIGS.[0127]24A-24B illustrate still another embodiment ofdefect repair device130. In this embodiment,defect repair device130D has adistal patch244 of a flexible, biocompatible material attached to awire frame246, much likedistal patches206,208,210 of FIGS.21-23.Wire frame246 may be continuous wire of stainless steel, Nitinol™, or other biocompatible, resilient metal or polymer, and may include a plurality ofloops248 like those shown in FIGS.21-23. Rather than being attached to a proximal patch like the above-described embodiments, however,distal patch244 of FIG. 24 is attached to acentral hub250, to which are coupled a plurality of radially-extendingstruts252 on the proximal side ofpatch244 and parallel thereto. Whiledefect repair device130D is pictured with four such struts in FIGS.24A-24B, struts252 may be between three and twelve in number.Struts252 are Nitinol, stainless steel, or other flexible, resilient biocompatible metal or polymer, and are coupled tohub250 in such a way that the outer ends254 ofstruts252 are biased towardpatch244 and deflectable away frompatch244 about an axis perpendicular to the central axis ofhub250. An additional patch (not shown) may be attached tostruts252 to provide patches on both sides of septum S, although in most cases, a single patch on the higher pressure side of the septum (the left side of the heart) is sufficient to prevent interatrial or interventricular blood flow through a septal defect.
• In the embodiment shown, the inner ends[0128]256 ofstruts252 are formed in a loop which acts as a torsion spring to bias the struts towardpatch244. Alternatively, inner ends256 may be straight and anchored directly tohub250, wherein eachstrut252 acts as a leaf spring biased towardpatch244. Optionally,distal struts260 coupled tohub250 may be provided adjacent to or attached to patch244, distally and parallel tostruts252, so as to compressively engage septum S between the two sets of struts, as shown in FIG. 24B. In the embodiment shown, each ofstruts252 is formed with one ofdistal struts260 from a single continuous length of wire, with a first loop at theinner end256 of eachstrut252, and a second loop at theinner end262 of eachdistal strut260. Aretainer261, which may be a snap-ring, band, or loop of suture, retainsstruts252 anddistal struts260 onhub250.Struts252,260 may be round in cross-section, or rectangular so as to increase the moment of inertia in the transverse direction so that the struts tend to bend only about an axis perpendicular to the central axis ofhub250. Outer ends254,264 ofstruts252 anddistal struts260 may include asharp point258 oriented generally perpendicular to the straight portion of the strut so as to partially penetrate septum S, as shown in FIG. 24B.Points258 may alternatively be made long enough so that the points completely penetrate septum S, allowing visual inspection of strut deployment by observing emergence of each point on the opposite side of the septum. In one embodiment, outer ends254 are formed in a 270° loop so thatpoints258 attain a perpendicular orientation.Hub250 includes a threadedhole266 which may be coupled to an introducer shaft.
• [0129]Defect repair device130D of FIG. 24A is shown in FIG. 25A in a collapsed configuration withindelivery shaft134 for introduction into the heart throughaccess device22.Hub250 is threadably mounted to arod273 attached to the end of an elongatedtubular introducer shaft268 to facilitate deployment ofrepair device130D within the heart.Patch244 anddistal struts260 are collapsed together distally ofhub250, whilestruts252 are collapsed together proximally ofhub250. Spring loops at the inner ends256,262 ofstruts252,260 bias the struts outwardly against the inner wall ofdelivery shaft134. Aretraction wire270, which may be a length of suture or wire, is attached to theouter end254 of eachstrut252 and extend through the interior ofintroducer shaft268. After deployment ofrepair device130D,retraction wires270 may by used to retract the device back intodelivery shaft134 to reposition or remove the device. Bytensioning retraction wires270 from outside of the patient's body, struts252 are re-collapsed andrepair device130 may be pulled back intodelivery shaft134. Preferably,retraction wires270 are looped throughouter ends254 of the struts so that both ends of the retraction wires extend out of the body throughdelivery shaft134. In this way, oncerepair device130D is deployed satisfactorily,retraction wires270 may be removed by simply pulling one end. Short lengths of suture or wire (not shown) may also be connected betweenouter ends254 of adjacent pairs ofstruts252, and aretraction wire270 then looped through each short length. This configuration helps to maintain spacing betweenstruts252 and prevent tangling. Alternatively, a single retraction wire may extend through all of the loops at the outer ends ofstruts252, with both ends of the single retraction wire extending out of the patient's body throughdelivery shaft134.
• FIG. 25B illustrates an exemplary embodiment of an[0130]actuator handle249 mounted to a proximal end ofdelivery shaft134 for deployingrepair device130D.Delivery shaft134 is slidably received within anaxial bore251 in a distal end ofactuator handle249. Anactuator button253 is slidably mounted to apost255 attached to a proximal end ofdelivery shaft134, and is biased outwardly by aspring257.Button253 extends through anaxial channel259 inactuator handle249, and has an enlargedinner portion263 which is slidably received withindetents265 at spaced-apart positions alongchannel259. In this way,button253 is locked in position when enlargedinner portion263 is received indetents265, and to movedelivery shaft134,button253 is pushed inward and either proximally (to deployrepair device130D) or distally (toretact repair device130D).Detents265 are positioned so as to correspond respectively withrepair device130D being fully retracted withindelivery shaft134,distal patch244 being deployed fromdelivery shaft134, and struts252 being deployed fromdelivery shaft134.Introducer shaft268 extends out of the proximal end ofdelivery shaft134 and is rotatably mounted to the proximal end ofactuator handle249. Arotatable knob267 is mounted near the proximal end ofintroducer shaft268 and is exposed through aslot269 in the side of actuator handle249 to allow rotation ofintroducer shaft268 for decoupling fromrepair device130D.Retraction wires270 extend through the interior ofintroducer shaft268 and extend out of actuator handle249 through ahole271 in the proximal end thereof.
• FIGS. 26A and 26B illustrate the deployment of[0131]defect repair device130D of FIGS.24A-24B.Repair device130D is delivered through access device22 (not shown) into the heart in the collapsed configuration of FIG. 25 withindelivery shaft134. In the case of an atrial septal defect,delivery shaft134 is introduced so that itsdistal end136 is on the left atrial side of septum S, as shown in FIG. 26A.Introducer shaft268 is then advanced distally relative todelivery shaft134 untilpatch244 is deployed from thedistal end136 of the delivery shaft. Upon deployment,distal struts260 and/or frame246 (not shown) ofpatch244 spring outwardly to an expanded configuration in which patch244 is generally flat and parallel to septum S within the left atrium.Delivery shaft134 andintroducer shaft268 are then pulled proximally so thatpatch244 engages septum S and points258 ondistal struts260 penetrate into septumS. Delivery shaft134 is then pulled further proximally relative tointroducer shaft268 so that struts252 are deployed fromdelivery shaft134, allowing them to spring outwardly and toward septum S, anchoringpatch244 in position as shown in FIG. 26B.
• If the position of[0132]patch244 is not satisfactory,retraction wires270 may be tensioned to retractstruts252 back intodelivery shaft136.Introducer shaft268 may then be pulled proximally to retractpatch244 back into the delivery shaft, orintroducer shaft268 may be pushed distally to disengagepatch244 from septum S, then manipulated to reposition the patch at the desired location.Struts252 are then re-deployed in the manner described above. Oncepatch244 is positioned satisfactorily on septum S,retraction wires270 are removed fromstruts252,introducer shaft268 is decoupled fromhub250, and the introducer shaft anddelivery shaft134 are removed from the heart.Access device22 is then removed from the heart, the penetration in the heart wall is closed, and the procedure completed as described above.
• It should be noted that in any of the foregoing embodiments of[0133]defect repair device130, a portion of the patient's own pericardium may be excised and mounted to the frame or struts of the defect repair device as a patch. In an exemplary embodiment, endoscopic scissors and graspers are introduced throughaccess ports90 and used to cut and remove a portion of pericardium of suitable size to cover the septal defect. Exterior to the chest cavity, the pericardial patch is then sutured onto a wire frame similar toframes224,226,228 of FIGS.21-23, or onto struts likestruts252,260 of FIGS.24-26. If desired, two pericardial patches may be mounted to two frames or two sets of struts interconnected by a hub to provide patches on both sides of the cardiac septum. Once the pericardial patch is attached to the frame or struts, the defect repair device is introduced into the heart throughaccess device22 and attached to the cardiac septum as described above. Advantageously, the use of the patient's own pericardium reduces the risk of biologic incompatibility and other potential complications of artificial patch materials.
• A further embodiment of a septal defect repair device according to the invention is shown in FIGS.[0134]24C-24H. Referring to FIGS.24C-D,repair device130E comprises adistal patch450 and aproximal patch452 connected to acentral hub454. A plurality ofstruts456 are connected at their inner ends tohub454 and extend radially outward therefrom.Struts456 may be between2 and20 in number, more usually between3 and12 in number, and preferably between4 and9 in number, depending upon the shape and size ofpatches450,452. In the particular embodiment illustrated,patches450,452 are generally septagonal, with seven ofstruts456 extending outwardly fromhub454 to the apices of the septagon for each of the patches.
• [0135]Patches450,452 are made of a flexible biocompatible material suitable for implantation in the heart and conducive to endothelialization. Expanded polytetrafluoroethylene, polyester, or other man-made materials may be used, as well as bovine or porcine tissue, or autologous tissue such as a piece of the patient's pericardium. In a preferred embodiment,patches450,452 each consist of two layers, withstruts456 sandwiched between the two layers. The two layers are then attached to one another to attach patches to the struts. In an exemplary embodiment, eachpatch450,452 has anunderlayer453 made of a knitted polyester material such as Bard Style 6103 cardiovascular material, 0.20 mm in thickness, and anouter layer455 of polyester velour such as Bard Style 6108 cardiovascular material, 0.44 mm in thickness. The soft and porous velour surface ofouter layer455 is disposed on that side of each patch which faces outward toward the cardiac chamber so as to promote endothelialization over the exposed surface of the patch that comes into direct contact with blood.Inner layer453 andouter layer455 are then attached together using thermal or ultrasonic welding, a suitable biocompatible adhesive, sutures, staples or other appropriate fasteners. In a preferred embodiment,outer layer455 is ultrasonically welded toinner layer453 at a plurality of weld points457 around the periphery of the layers and along each side ofstruts456.Outer layer455 is attached tohub454 in the manner described below.
• [0136]Struts456 are preferably relatively stiff to supportpatches450,452 against the pressures of blood flow within the heart, being made of stainless steel, Nitinol, or other biocompatible metal or polymer. At the same time, struts456 are collapsible into a configuration suitable forpositioning delivery device130E withindelivery shaft134, as shown in FIG. 24H. Preferably, a single continuous piece of wire is used to form two opposingstruts456A,456B positionable on opposite sides of the cardiac septum. As shown in FIG.24E, whereinpatches450,452 have not yet been attached to the device, each of struts456A,456B has a coiledsection458 at its inner end that allows the strut to deflect about an axis perpendicular to the axis ofhub454.Struts456A are preferably biased toward the opposingstruts456B, and vice versa, as shown in FIG. 24E, so as to compress the cardiac septum between the two sets of struts, firmly maintaining the position of the device in the heart. At the outer ends of the struts, anadditional loop460 is formed, and preferably, on at least one side of the cardiac septum, theends462 ofstruts456 are sharpened and oriented generally orthogonal to the radial section of the strut (perpendicular to the plane of patch452) so as to penetrate the cardiac septum to anchor the device in position. In some embodiments, all ofstruts456 will have right-angled, sharpened ends462 to penetrate the cardiac septum.Loops460 serve not only as a convenient technique for formingends462 in a right-angled configuration, but further provide an eyelet through which a suture or retraction wire may be inserted for retracting theproximal patch452 after initial deployment, as described below.
• [0137]Hub454, illustrated in FIGS.24F-G, is preferably a rigid biocompatible metal or plastic suitable for implanting in the heart.Inner loops458 ofstruts456 are disposed inaxial slots464 inhub454.Struts456 are maintained onhub454 by means of a retainingring466 disposed abouthub454 in acircumferential recess468. Retainingring466 may consist of several wraps of suture material tied aroundhub454, or a metallic wire or snap ring. A threadedbore470 in one side ofhub454 facilitates attachment to a rod for deployment of the device, as described below.Hub454 further includes a means for connecting eachpatch450,452 to the hub, preferably comprising a plurality ofenergy directors472 extending axially from each end of the hub. In this embodiment,hub454 is made of a plastic suitable for thermal or ultrasonic welding topatches450,452. When assemblingrepair device130E,energy directors472 are contacted by a thermal or ultrasonic welding head which melts and compresses the energy directors against the end ofhub454 to weld the energy directors to the patch material, thereby fasteningouter layer455 tohub454.
• FIG. 24H illustrates[0138]repair device130E in a collapsed configuration withindelivery shaft134. The threaded distal end ofinner control rod268 is attached tohub454, and a suture or otherflexible retraction wire270 is threaded throughouter loops460 ofstruts456.Struts456 ofdistal patch450 are rotationally deflected away fromstruts456 ofproximal patch452 untilpatches450,452 may be inserted into the inner lumen ofdelivery shaft134, withouter ends462 engaging the inner surface ofdelivery shaft134. In this way, upon deployment of each patch from the delivery shaft, struts456 will spring back toward their unbiased configuration, shown in FIG. 24E, thereby expanding the patch to its fully expanded configuration of FIG. 24C. If, following initial deployment, it is desired to retractrepair device130E back intodelivery shaft134,retraction wire270 is tensioned, thereby re-collapsingproximal patch452.Delivery shaft134 is then advanced distally overproximal patch452 and overdistal patch450, which collapses as it is engaged by the delivery shaft. The device may then be repositioned and redeployed across the septal defect.
• FIGS.[0139]35A-D illustrate a visualization device and guide sleeve useful in connection with the septal defect repair devices of the invention. As shown in FIG. 35A, acontact scope400 includes atubular sheath402 having atransparent bulb404 of glass or a clear plastic such as acrylic, polystyrene, or polycarbonate at its distal end.Bulb404 has a convexdistal surface406 configured to provide a wide-angle view distally throughbulb404. Anaxial lumen408 extends throughsheath402 and terminates within or just proximal tobulb404. A pair offlanges410,412 are disposed at the proximal end ofsheath402 and are spaced axially apart from each other for reasons described below. Alternatively,bulb404 may be an expandable balloon in communication with an inflation lumen extending throughsheath402, similar to that described above in connection with FIG. 8B.
• [0140]Axial lumen408 is dimensioned to receive an endoscope orthoracoscope414, which may be any of a variety of commercially-available endoscopes or thoracoscopes, such as those described above in connection with FIG. 8B.Shaft416 ofthoracoscope414 is inserted intolumen408 anddistal end418 advanced up to the distal end oflumen408, enabling the user to look througheyepiece420 and view the body cavity throughbulb404. Optionally, a video camera may be connected to eyepiece420 to allow the user to view the body cavity on a video monitor. Afiber optic connector422 is also provided to facilitate connection of a light source which transmits light into the body cavity through optical fibers (not shown) extending longitudinally throughshaft416. In other embodiments,bulb404 may be mounted directly to the distal end ofthroracoscope414, eliminating the need forseparate sheath402.Bulb404 serves not only to provide a wide-angle view throughthoracoscope414, but further to displace blood away from the distal end of the thoracoscope to facilitate visualization within the blood-filled heart.Bulb404 may be placed against the surface of the septum, and manipulated to identify the location of a septal defect.
• FIG. 35B illustrates a[0141]guide sleeve424 useful in conjunction withcontact scope400 to maintain contact with a septal defect once located.Guide sleeve424 comprises atubular shaft426 preferably constructed of a fairly rigid material such as stainless steel or a rigid biocompatible polymer. Alongitudinal channel428 extends throughshaft426 and is configured to removably receivecontact scope400 such thatbulb404 may be positioned at thedistal end430 ofshaft426 withconvex surface406 protruding distally therefrom, as illustrated in FIG. 35C. In an exemplary embodiment,tubular shaft426 is about 15-30 cm in length for adult use, about 10-20 cm for pediatric use, with an outer diameter of about 7-12 mm and an inner diameter of about 5-10 mm. Aflange432 is provided at the proximal end ofshaft426 which contacts flange410 whencontact scope400 is properly positioned inguide sleeve424. Becausesheath402 has sufficient length to extend over the full length ofshaft416 ofendoscope414, the axial spacing offlange412 apart fromflange410 is selected to position the distal end ofguide sleeve424 proximate to the distal end ofsheath402 when the proximal end of the guide sleeve is againstflange410.
• The use of[0142]contact scope400 and guidesleeve424 is illustrated in FIGS.36A-36E. As shown in FIG. 36A,access device22 is introduced through atrocar sleeve90 and into the atrium or ventricle through an outer wall of the heart H in the manner described above. A purse string suture serves to seal the penetration in the wall of the heart to prevent blood loss.Thoracoscope414 is inserted intocontact scope400 which is inserted intoguide sleeve424, and the assembly is introduced throughaccess device22 into the heart. The user may view the interior of the heart througheyepiece420 andbulb404 to locate the septal defect to be repaired. Usuallybulb404 will be placed in contact with the cardiac septum and manipulated until the defect is found. Once the defect is located,guide sleeve424 is advanced distally until itsdistal end430 is positioned through the septal defect D, as shown in FIG. 36B.Contact scope400 andthoracoscope414 are then removed fromguide sleeve424.
• By positioning[0143]guide sleeve424 in septal defect D, the user maintains contact with the defect and can relocate it easily without repeated use ofcontact scope400. A defect repair device may then be inserted throughguide sleeve424 and used to close the defect. FIGS.36C-E illustrate the placement of a patch-typedefect repair device130E like that described above with reference to FIGS.24C-H. Delivery shaft134 is inserted throughguide sleeve424 so that its distal end is positioned through defect D, as shown in FIG. 36C.Guide sleeve424 may then be retracted proximally relative todelivery shaft134.Actuator button253 onhandle249 is then slid proximally so as to deploydistal patch450 on that side of the defect further away from the user, shown in FIG. 36D. Handle249 is then manipulated to bringdistal patch450 in contact with the septum around defect D. Actuator button is slid further proximally alonghandle249 to deployproximal patch452.
• At this point, patch placement can be checked by removing[0144]delivery shaft134 while leavingcontrol rod268 and the retraction wire or suture (not shown in FIG. 36E) connected to repairdevice130E.Contact scope400 andthoracoscope414 may be reinserted throughguide sleeve424 to inspect placement of the repair device. If repositioning is desired,delivery shaft134 may be reinserted throughguide sleeve424 andrepair device130E retracted into the delivery shaft for redeployment. If placement is satisfactory,control rod268 is decoupled fromrepair device130E anddelivery shaft134 removed from the heart.Guide sleeve424 is removed fromaccess device22, and the procedure completed as described above.
• It will be understood that, while[0145]contact scope400 and guidesleeve424 have been described in conjunction withdefect repair device130E, the contact scope and guide sleeve of the invention will be useful with any of the defect repair devices described herein, including other configurations of patch-type devices as well as the suture-based closure devices described below.
• In another embodiment of the invention, illustrated in FIGS.[0146]27-33, an apparatus and method are provided for closure of septal defects using sutures, rather than patch-type defect repair devices. In this embodiment, a plurality ofneedles274 are mounted to adistal end276 of anintroducer shaft278.Needles274 are held parallel tointroducer shaft278 in a generally circular arrangement coaxial with the introducer shaft.Needles274 may be between 2 and 12 in number, and preferably are 4, 6, or 8 in number, depending upon the size of the defect to be closed. A length of suture thread275 (best seen in FIG. 28) extends between each pair ofneedles274, each pair having one needle on opposite sides of an imaginaryline separating needles274 into two equal groups.
• Introducer[0147]shaft278 is preferably a rigid material such as stainless steel for optimum control in manipulating and positioningneedles274 from outside of the chest cavity. Alternatively, all or a distal portion ofintroducer shaft278 may be a flexible material and may include means for deflecting or steeringdistal end276, such as pull wires anchored internally todistal end276 and extending through the introducer shaft to an actuator at the proximal end for selectively tensioning the pull wires.Introducer shaft278 may be used to introduceneedles274 throughaccess device22 into the right atrium RA, and through septal defect D into left atrium LA, as illustrated in FIG. 27.Needles274 have sharpdistal tips280 oriented so as to point in a proximal direction toward septum S from left atrium LA, and are held removably at their proximal ends282 inneedle holders284 extending distally from the distal end ofintroducer shaft278.Needle holders284 comprise flexible rods of stainless steel, titanium, Nitinol® (Raychem Corp.), or a biocompatible polymer, having a needle holding cup285 (seen more clearly in FIGS.28-29) at their distal ends in which needles274 are inserted.
• An[0148]expandable element286 is disposed concentrically within the space surrounded byneedles274 distal tointroducer shaft278.Expandable element286 may comprise an inflatable balloon having an interior in communication with aninflation tube288 extending through an inner lumen inintroducer shaft278. Alternatively,expandable element286 may comprise a rigid camming element such as a disk, cylinder, or ball fixed to the end of amovable shaft288.
• As illustrated in FIG. 28,[0149]expandable element286 is expanded by, e.g., introducing an inflation fluid throughinflation tube288.Expandable member286 urgesneedle holders284 outward so thatdistal tips280 are pointed toward septum S around the periphery of defect D.
• With[0150]needle holders284 in a radially-expanded position,introducer shaft278 is drawn proximally relative to accessdevice22 so that needledistal tips280 penetrate septum S, as shown in FIGS.29A-29B. It can be seen that cups285 onneedle holders284 are held in an offset relationship toflexible rods287 so that whenrods285 engage septum S at the periphery of defect D, needles274 are spaced outwardly a predetermined distance from the edge of the defect to ensure adequate spacing and “bite” on the septal tissue. Preferably, eachneedle274 penetrates septum S about 1-3 mm from the edge of defect D.
• As best seen in FIG. 29B,[0151]introducer shaft278 may comprise a plurality ofaxial tubes290 in which needleholders284 are disposed.Needle holders284 are slidable withintubes290 so thatneedles274 may be moved proximally relative totubes290 untildistal tips280 enter the open distal ends292 oftubes290. A distal portion oftubes290 may be flared or widened to facilitate receivingneedles274. A means for capturing needles274 (not shown) is provided withintubes290 near distal ends292, such as a porous mesh or screen of a biocompatible material such as Gore-Tex®, cotton, or Dacron, which may be penetrated bydistal tips280 ofneedles274. Abarb294 is provided onneedles274 just proximal todistal tips280 which may be caught in the needle capturing means withintubes290 to retainneedles274 therein. Onceneedles274 are captured withintubes290,introducer shaft278 is drawn proximally relative toneedle holders284, pullingneedles274 through septumS. Expandable member286 may then be deflated, andexpandable member286 along withneedle holders284 are then pulled proximally through defect D. Introducer shaft278 (to which needles274 are attached at distal ends290),introducer shaft278, andinflation tube288 are then withdrawn from the heart throughaccess device22.
• In an alternative embodiment, illustrated in FIGS.[0152]30A-30B, the means for capturingneedles290 comprises anouter sleeve296 slidably disposed overintroducer shaft278.Outer sleeve296 has acapture disk298 on its distal end which has a penetrableouter layer300 comprising a porous mesh, sponge, or screen of a biocompatible material such as Gore-Tex®, cotton, or Dacron. To captureneedles274, as shown in FIG. 30A,expandable member286 is deflated, andouter sleeve296 is slid distally overintroducer shaft278 untildistal tips280 ofneedles274 penetrateouter layer300 ofcapture disk298.Barbs294 are caught in the porous material ofouter layer300.Outer sleeve296 may then be drawn proximally relative tointroducer shaft278 as shown in FIG. 30B, pullingneedles274 through septumS. Expandable member286 andneedle holders284 are then withdrawn through defect D. Outer sleeve296 (to which needles274 are attached),introducer shaft278, andinflation tube288 are then withdrawn from the heart throughaccess device22.
• [0153]Capture disk298 may be a flexible foam or solid material such as natural or synthetic rubber (e.g. silicone), thermoplastic elastomer, or polyurethane so as to be collapsible for introduction and removal from the heart throughaccess device22. Alternatively,capture disk298 may be an expandable member such as an inflatable balloon or expandable basket which allows introduction and removal throughaccess device22 in a collapsed state, and expansion into an expanded state within the heart for capturingneedles274. In either case,capture disk298 has sufficient rigidity when expanded to allowneedles274 to penetrateouter layer300 without the capture disk over-flexing or collapsing.
• As a further alternative technique for capturing[0154]needles274 after they have penetrated septum S, needles274 are removed fromcups285 by pushing distally onneedle holders284.Expandable member286 is then deflated and withdrawn through defect D along withneedle holders284.Introducer shaft278,inflation tube288 andneedle holders284 are then withdrawn from the heart throughaccess device22, leavingneedles274 extending through septum S. An elongated endoscopic needle driver (not shown) may then be introduced throughaccess device22 into the heart, and, under visualization with ultrasound, a endoscope, or fluoroscope, the needle driver is used to grasp eachneedle274 and pull it through septum S and out of the heart throughaccess device22.
• When needles[0155]274 have been withdrawn from the heart, at least one, and usually two to six loops of suture (depending upon the number of needle pairs used), will have been formed across defect D, as illustrated in FIGS.31A-31B.Suture threads275 are long enough, usually at least about 30 cm in length, to extend across defect D and through septum S, with both ends extending out of the heart and chest cavity throughaccess device22. In this way, sutures275 may be tensioned to draw defect D closed, and knots formed extracorporeally and pushed into the heart throughaccess device22 using an elongated endoscopic knot pusher. As shown in FIG. 31C, a plurality ofknots304 are formed in eachsuture275 and pushed against septum S to ensure tight closure ofdefect D. Sutures275 are then trimmed using elongated endoscopic scissors introduced throughaccess device22. Complete closure and absence of shunting is verified using transesophageal echocardiography or one of the other visualization techniques outlined above.
• An alternative embodiment of a septal defect repair device according to the invention is illustrated in FIGS.[0156]32A-32D. This embodiment ofdefect repair device130 is in many respects similar to that described above in connection with FIGS.27-30, the major difference being thatneedle holders284 are pre-shaped so as to be biased outward into the radially-expanded configuration shown in FIG. 32B.Needle holders284 may be stainless steel, a shape-memory alloy such as nickel-titanium, or another flexible and resilient metal or polymer.Needle holders284 may be long enough to extend entirely out of the body cavity throughaccess device22, or they may be attached to an introducer shaft (not shown) as in the above embodiments. As shown in FIG. 32A, a restrainingsleeve306 is slidably positioned overneedle holders284 and may be advanced distally relative to the needle holders to urgeneedle holders284 inward into a collapsed position for introduction throughaccess device22 and through defect D. A distal portion ofneedle holders284 is pre-shaped in an outward bend or curve so that, when restrainingsleeve306 is retracted,needle holders284 return to a radially-expanded position in which needles274 are positioned outside of a circle defined by the diameter of defect D. As in previous embodiments,needle holding cups285 are offset relative torods287 ofneedle holders284 so thatneedle holders284 move outward untilrods287 engage septum S at the periphery of defect D. Needles274 are then positioned at a predetermined spacing from the edge of defect D to ensure adequate “bite” into septal tissue.
• The embodiment of the defect repair device of FIGS.[0157]32A-32D is otherwise similar to the embodiments of FIGS.27-31 described above. As shown in FIGS.32C-32D, afterneedles274 have been drawn through septum S around defect D, the needles are captured by means of acapture disk298 with a porousouter layer300, or by another means such as endoscopic needle drivers introduced throughaccess device22, as described above. After capture ofneedles274, restrainingsleeve306 is advanced distally to collapseneedle holders284 inward, andneedle holders284, restrainingsleeve306,capture disk298, and needles274 are withdrawn from the heart throughaccess device22. This leaves sutures275 extending across defect D as shown in FIGS.31A-31B;sutures275 are then tensioned, knots are formed insutures275 extracorporeally, and the knots are pushed into the heart and against septum S using an endoscopic knot pusher, closing defect D as illustrated in FIG. 31C. A suitable knot pusher is disclosed in copending application Ser. No. 08/288,674, entitled “Surgical Knot Pusher and Method of Use,” filed Aug. 10, 1994, the disclosure of which is hereby incorporated herein by reference.
• It should be noted that while the method of the invention has been described in connection with the repair of atrial septal defects, it will be understood to those of ordinary skill in the art that the invention will be equally applicable to repair of ventricular septal defects, patent ductus arteriosus, and other defects of the heart.[0158]Access device22 may also be introduced through a wall of the right ventricle, left atrium, pulmonary artery, or pulmonary vein rather than the right atrium. Alternatively,access device22 may be introduced into the right atrium as previously described, with access to the right ventricle or pulmonary artery obtained from the right atrium through the tricuspid valve. Devices and techniques similar to those described above for atrial septal defects may be used for repairing ventricular defects and patent ductus arteriosus. Other repair devices designed specifically for ventricular septal defects and patent ductus arteriosus which are useful in the method of the present invention are described in U.S. Pat. No. 3,874,388, which has been incorporated herein by reference. The defect repair devices of the invention may also be used to repair the penetration in the heart wall made byaccess device22, and to repair other types of defects, holes, incisions, or punctures in other organs and tissue structures.
• In addition to repair of atrial and ventricular septal defects and patent ductus arteriosus, the devices and methods of the invention also facilitate various other intracardiac interventions, including electrophysiological mapping and ablation. FIGS. 33 and 34 illustrate two embodiments of an electrophysiological device according to the invention. In the embodiment of FIG. 33, an[0159]electrophysiology device310 is introduced throughaccess device22 into a chamber C of the heartH. Electrophysiology device310 includes arigid shaft312 having adistal end314 and aproximal end316. Usually, at least one inner lumen (not shown in FIG.33) extends throughshaft312 betweendistal end314 andproximal end316. A flexible and pre-shaped ordeflectable tip318 is attached todistal end314. Ahandle320 is attached toproximal end316. A plurality ofconductive electrode bands322 are mounted todeflectable tip318, each electrode band being separately electrically coupled by means of wires (not shown) withinshaft312 to aconnector324 onhandle320.Connector324 is adapted to be coupled to acord326 which is connected to a radiofrequency generator or electrocardiography machine (not shown) used in conventional mapping and ablation procedures. Anactuator328 is slidably coupled to handle320 and is connected todeflectable tip318 by at least one pull wire (not shown) extending slidably through an inner lumen inshaft312 and attached internally todeflectable tip318 near itsdistal end330. In this way, slidingactuator328 proximally onhandle320 deflectsdeflectable tip318 into a curved configuration, as illustrated in FIG. 33. Of course, various types of actuators may be used for deflection ofdeflectable tip318, including shapable or deflectable handles, joy-sticks, levers, pistol grips, and the like. In addition,shaft312 may be rotatably coupled to handle320, and a rotator knob (not shown) may be attached toshaft312 nearproximal end316 to allowdeflectable tip318 to be rotated about the longitudinal axis ofshaft312. Exemplary mechanisms for actuation and deflection ofdeflectable tip318 and other features which may be incorporated intoelectrophysiology device310 are disclosed in U.S. Pat. Nos. 4,960,134, 5,318,525, 5,368,592, 5,364,351, and 5,313,943, which are incorporated herein by reference. While these patents disclose highly flexible, endovascular electrophysiology catheters for introduction transluminally from a peripheral vessel into the heart, it will be understood to those of ordinary skill in the art that any of the features of endovascular electrophysiology devices may be easily incorporated into the more rigid, thoracoscopic electrophysiology device of the invention.
• [0160]Shaft312 has a length which is long enough to extend from within chamber C of heart H throughaccess device22 outside of the patient, usually being 20-30 cm in length.Shaft312 is preferably rigid, usually being made of stainless steel (with insulated electrodes and wires) or of a rigid biocompatible polymer, so as to facilitate precise and controllable positioning ofdeflectable tip318 from outside of the chestcavity using handle320.Deflectable tip318 is a non-conductive, flexible and biocompatible polymer such as polyurethane, silicone, thermoplastic elastomer, polyolefin, polyamide, or a fluoropolymer.
• In an alternative embodiment, illustrated in FIG. 34,[0161]electrophysiology device310 includes, rather than adeflectable tip318 as in the previous embodiment, anexpandable electrode array332 attached todistal end314 ofshaft312. In a preferred embodiment,electrode array332 comprises a plurality ofelectrode bands334 mounted in spaced-apart positions to anexpandable basket336.Expandable basket336 includes a plurality of axially-orientedbeams338, which are preferably a non-conductive, flexible and resilient polymer such as a polyolefin or polyamide, or a metal such as stainless steel or nickel-titanium alloy with an insulative coating to electrically isolate each ofelectrode bands334.Beams338 are coupled together at theirdistal ends340, and at their proximal ends are attached toshaft312. In one embodiment,shaft312 is a polymeric tubular extrusion, and beams338 are formed integrally withshaft312 as part of the same extrusion, by, for example cutting axial slits in a distal portion ofshaft312. As in the embodiment of FIG. 33, each ofelectrode bands334 is independently electrically coupled toconnector324 by a wire extending through an inner lumen inshaft312.
• Expandable[0162]basket336 is movable between a collapsed configuration suitable for introduction throughaccess device22 and an expanded configuration in which electrodebands334 are spread apart into a three-dimensional array, positioned at various distances both radially outward from and distal toshaft312, as shown in FIG. 34. In this way,electrode bands334 may be simultaneously positioned at a number of locations around the interior wall of chamber C. To moveexpandable basket336 between the collapsed and expanded configurations, a variety of different mechanisms may be utilized. In one embodiment, apull wire342 is coupled todistal ends340 ofbeams338, and extends slidably through a lumen inshaft312 for attachment toactuator328. In this way,actuator328 may be slid in a proximal direction to exert a compressive force onbeams338, causingbeams338 to bow outward into the expanded configuration. When pressure is released fromactuator328,beams338 recoil to their unstressed, straight configuration.
• In addition to the embodiment illustrated, various types of structures may be used for[0163]electrode array332, including those disclosed in U.S. Pat. Nos. 4,699,147, 4,660,571, 4,628,937, 4,522,212, 5,313,943, and 5,327,889, which are incorporated herein by reference. Although these patents describe endovascular electrophysiological catheters, it will be understood to those of ordinary skill in the art that the electrode array configurations, structures and deployment mechanisms disclosed may be easily adapted to the larger diameter, shorter and more rigid thoracoscopic electrophysiology device of the present invention.
• [0164]Electrophysiology device310 may be used for either mapping or ablation of conduction pathways in the heart. In use,electrophysiology device310 is introduced into chamber C of heart H throughinner lumen30 ofaccess device22. Chamber C may be the left or right ventricle, or left or right atrium, depending upon where the target site for mapping or ablation is located. If the target site is in the higher pressure left side of the heart,access device22 is provided with a hemostasis seal ininner lumen30 to allow introduction ofelectrophysiology device310 without significant leakage of blood. For the device of FIG. 33,deflectable tip318 is substantially straight and undeflected during introduction. For the device of FIG. 34,expandable basket336 is in a collapsed state in which beams338 are substantially straight and aligned withshaft312 during introduction. Once introduced into chamber C,deflectable tip318 is deflected (in the embodiment of FIG. 33) orexpandable basket336 is expanded into an expanded configuration (in the embodiment of FIG. 34) by slidingactuator328 onhandle320. Under visualization using transesophageal echocardiography or one of the other techniques described above,electrodes322,334 are positioned at the desired location against the wall of chamber C by manipulating the device withhandle320. The relatively short distance between the user and the interior of chamber C, as well as the rigidity ofshaft312, facilitate exceptionally controllable and precise manipulation of the device relative to endovascular catheter-based electrophysiology devices.
• When[0165]electrodes322,334 have been positioned at the desired site in chamber C, conduction pathways can be mapped by measuring the electrical potential between selected electrodes with sensitive electrocardiographic equipment. When aberrant pathways are found, they may be ablated by applying radiofrequency current from a radiofrequency generator through a selected electrode or electrodes onelectrophysiology device310 to the myocardial tissue. These techniques may be used to diagnose and/or treat ventricular tachycardias, ventricular fibrillation, supraventricular tachycardias such as Wolff-Parkinson-White Syndrome, atrial fibrillation, and other conduction-related diseases. Ablation may also be performed using a medical laser transmitted through an optical fiber introduced into the heart throughaccess device22, by techniques analogous to the endovascular laser ablation techniques disclosed in U.S. Pat. No. 5,104,393, which is incorporated herein by reference.
• In addition, thoracoscopic, endovascular, or open surgical devices and techniques may be used in conjunction with the devices and methods of the present invention. For example,[0166]electrophysiology device310 may be used to ablate selected cardiac tissue within the heart based on mapping information generated using endovascular mapping catheters or thoracoscopic mapping devices. Alternatively,electrophysiology device310 may be used for mapping conduction pathways in the heart, which are then treated by means of thoracoscopic, endovascular, or open-chest techniques. Such a technique could be used for treatment of ventricular and supraventricular tachycardias. Similarly, to treat atrial fibrillation, after intracardiac mapping has been performed using the electrophysiology device of the invention and/or endovascular mapping techniques, mechanical, laser, or RF cutting devices may be introduced throughaccess device22, and precise incisions or ablation lines may be made in the myocardium to create a directed conduction pathway between the sinoatrial node and the atrioventricular node to perform a Cox “maze” procedure.
• After the electrophysiology procedure is completed,[0167]deflectable tip318 is returned to its straightened configuration orexpandable basket336 is collapsed so thatbeams338 are again straight and aligned withshaft312.Electrophysiology device310 is then removed from the chest cavity throughaccess device22.
• In addition to repair of atrial and ventricular septal defects and cardiac mapping and ablation, the devices and techniques of the invention are useful in a variety of other intracardiac procedures. Low-profile, elongated instruments may be introduced through[0168]access device22 to inspect and repair the mitral, tricuspid, pulmonary or aortic valves. Commissurotomy may be performed, for example, by introducing a cutting instrument and incising the valve commissures to separate the valve leaflets. A collapsible valve prosthesis, such as those described in U.S. Pat. No. 5,370,685, or 5,411,552, which are incorporated herein by reference, could be introduced into the heart throughaccess device22 to replace a diseased heart valve. Transmyocardial laser revascularization may be performed by introducing a laser-transmitting optical fiber throughaccess device22 and using the laser to drill new blood-carrying conduits into the myocardium from within the heart chambers. Cutters, graspers, biters, and the like may be introduced throughaccess device22 to cut and remove unwanted tissue or other material from the heart and great vessels, such as thrombus (e.g. pulmonary thrombectomy), myxomas, neoplasms, vegetations, calcifications, and tissues affected by hypertrophic obstructive cardiopmyopathy. Catheters may also be introduced throughaccess device22 for positioning in the pulmonary artery, coronary sinus, or other locations for perfusion, drug delivery, fluid venting, and other purposes. Advantageously, many of these procedures can be performed while the heart is beating, without the need to place the patient on cardiopulmonary bypass and to induce cardioplegic arrest. In addition, these procedures can be performed without the need for a median sternotomy or other gross thoracotomy, reducing greatly the pain, recovery time, morbidity, and mortality associated with open heart surgery.
• While the above is a complete description of the preferred embodiments of the invention, it will be understood to one of ordinary skill in the art that certain modifications, substitutions, improvements and additions may be made without departing from the scope thereof, which is defined by the appended claims.[0169]

Claims (42)

What is claimed is:

1. An assembly for visualization and access within a body cavity comprising:

a sleeve having a distal end, a proximal end, and a lumen therebetween;

a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end,

a transparent bulb disposed at the distal end of the shaft outside of the channel and optically aligned with the lens.

2. The assembly ofclaim 1 wherein the transparent bulb is mounted to the distal end of the shaft.

3. The assembly ofclaim 1 wherein the transparent bulb is mounted to an elongate sheath having a proximal end, a distal end, and a lumen therebetween, the shaft being positionable in the lumen with the distal end of the shaft adjacent to the bulb.

4. The assembly ofclaim 1 wherein the transparent bulb is substantially rigid.

5. The assembly ofclaim 1 wherein the transparent bulb is made of a material selected from glass, acrylic, polystyrene, and polycarbonate.

6. The assembly ofclaim 1 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

7. The assembly ofclaim 1 wherein the transparent bulb has a distal surface, the distal surface being convex.

8. The assembly ofclaim 1 wherein sleeve has a length sufficient to reach an interior of a patient's heart from outside the patient's chest.

9. The assembly ofclaim 8 wherein the sleeve has a length of at least about 15 cm.

10. The assembly ofclaim 1 wherein the transparent bulb comprises an expandable member, the assembly further comprising an inflation lumen in communication with the expandable member for delivering an inflation fluid thereto.

11. The assembly ofclaim 1 wherein the sleeve is substantially rigid.

12. A contact scope for visualization within a body cavity comprising:

an elongate sheath having a distal end, a proximal end, a lumen therebetween, and a transparent bulb mounted to the distal end aligned with the lumen; and

a scope slidably positionable in the lumen, the scope having a shaft with a distal end, a proximal end and a channel therebetween, and a lens mounted in the channel near the distal end;

wherein the distal end of the shaft may be positioned within the lumen adjacent to the transparent bulb to allow viewing through the lens and the bulb.

13. The contact scope ofclaim 12 wherein the transparent bulb is substantially rigid.

14. The contact scope ofclaim 12 wherein the transparent bulb is made of a material selected from glass, acrylic, polystyrene, and polycarbonate.

15. The contact scope ofclaim 12 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

16. The contact scope ofclaim 12 wherein the transparent bulb has a distal surface, the distal surface being convex.

17. The contact scope ofclaim 12 wherein the transparent bulb comprises an expandable member, the sheath further comprising an inflation lumen in communication with the expandable member for delivering an inflation fluid thereto.

18. The contact scope ofclaim 12 further comprising a sleeve having an axial lumen, the sheath being removably positionable in the axial lumen.

19. A repair system for repairing a septal defect in a patient's heart, the repair system comprising:

a sleeve having a distal end, a proximal end, and a lumen therebetween;

a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end,

a transparent bulb disposed at the distal end of the shaft optically aligned with the lens; and

a septal defect closure device positionable through the lumen of the sleeve.

20. The repair system ofclaim 19 wherein the septal defect closure device comprises a delivery shaft having a distal end, a proximal end, and a patch releasably held at the distal end, the patch having a deployed configuration for positioning across a septal defect and a collapsed configuration for positioning through the lumen in the sleeve.

21. The repair system ofclaim 19 wherein the septal defect closure device is configured to apply a suture to the cardiac septum.

22. The repair system ofclaim 19 wherein the transparent bulb is mounted to the distal end of the shaft.

23. The repair system ofclaim 19 wherein the transparent bulb is mounted to an elongate sheath having a proximal end, a distal end, and a lumen therebetween, the shaft being positionable in the lumen with the distal end of the shaft adjacent to the bulb.

24. The repair system ofclaim 19 wherein the transparent bulb is substantially rigid.

25. The repair system ofclaim 19 wherein the transparent bulb comprises an expandable member, the assembly further comprising an inflation lumen in communication with the expandable member for delivering an inflation fluid thereto.

26. The repair system ofclaim 19 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

27. The repair system ofclaim 19 wherein the transparent bulb has a distal surface, the distal surface being convex.

28. The repair system ofclaim 19 wherein sleeve has a length sufficient to reach an interior of a patient's heart from outside the patient's chest.

29. The repair system ofclaim 28 wherein the sleeve has a length of at least about 15 cm.

30. The repair system ofclaim 19 wherein the sleeve has an outer diameter of less than about 12 mm.

31. The repair system ofclaim 19 wherein the sleeve is substantially rigid.

32. The repair system ofclaim 19 further comprising an access cannula having a distal end positionable through a wall of the heart, a proximal end, and an access channel therebetween, the sleeve being slidably positionable through the access channel into the heart.

33. The repair system ofclaim 32 wherein the access cannula has a flange on a distal end thereof for engaging an interior wall of the heart.

34. The repairs system ofclaim 32 further comprising an obturator removably positionable in the access channel.

35. The repair system ofclaim 34 wherein the obturator has a distal end configured to penetrate the wall of the heart.

36. A method of locating an opening in a patient's heart, comprising:

positioning a visualization scope through a sleeve;

positioning a distal end of the visualization scope into the heart through a penetration in a wall thereof;

viewing the opening through the visualization scope;

sliding the sleeve into the opening; and

removing the visualization scope from the sleeve.

37. The method ofclaim 36 further comprising the steps of:

positioning the visualization scope in a sheath outside the heart such that a distal end of the visualization scope is adjacent to a transparent bulb on a distal end of the sheath; and

positioning the sheath in the heart through the sleeve;

viewing the opening through the transparent bulb.

38. The method ofclaim 36 further comprising:

positioning a repair device through the sleeve while the sleeve is positioned through the opening; and

closing the opening with the repair device.

39. The method ofclaim 38 wherein the repair device comprises a patch which is secured across the opening.

40. The method ofclaim 36 wherein the visualization scope and the sleeve are positioned through an access cannula extending from outside the chest through the penetration in the wall of the heart.

41. The method ofclaim 36 wherein the heart remains beating during each of said steps.

42. The method ofclaim 36 wherein the opening comprises a septal defect.

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